Vertex Pharmaceuticals (VRTX 0.07%) has dominated the cystic fibrosis (CF) drug market for more than a decade. This has been a very lucrative business for the biotech, and it could continue generating steady revenue and earnings from its CF products until the late 2030s, when its most important products will lose patent exclusivity. However, since it takes a long time to develop brand-new drugs, it's a good idea for Vertex Pharmaceuticals to start preparing for these patent cliffs.
Besides, there is always the possibility (however remote, considering past attempts) that another company will succeed in cracking the CF code and market competing medicines. If that happens, Vertex's shares could fall off a cliff. That's why it's important for the company to diversify its portfolio, and Vertex Pharmaceuticals recently announced an acquisition that will help it do so.
Image source: The Motley Fool.
A new acquisition could move the needle On July 6, Vertex Pharmaceuticals announced it was acquiring Crinetics Pharmaceuticals (CRNX 0.06%), a biotech focused on developing medicines for endocrine diseases, for $10 billion in cash. The buyout will grant Vertex Pharmaceuticals access to Palsonify, a medicine approved to treat acromegaly, a rare condition caused by a benign pituitary tumor that produces too much growth hormone, causing abnormal growth of bones, organs, and other tissues.
The U.S. Food and Drug Administration approved Palsonify in 2025. Beyond this marketed product, Crinetics Pharmaceuticals boasts several interesting pipeline candidates that Vertex will inherit. For instance, Crinetics is developing atumelnant, an investigational therapy for congenital adrenal hyperplasia (CAH), a group of rare genetic disorders that can be dangerous, even life-threatening, for newborns in severe cases.
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Vertex Pharmaceuticals believes that Crinetics Pharmaceuticals' Palsonify and phase 3 assets have a combined peak revenue potential of about $5 billion. That's a meaningful amount for a company that generated $12 billion in revenue last year. That's why this acquisition -- and the clinical and commercial progress Vertex could make thanks to it -- is worth keeping an eye on for investors.
Vertex Pharmaceuticals' strong outlook Vertex Pharmaceuticals has already made good progress in diversifying its lineup and pipeline. The company's approved portfolio includes Journavx, a medicine for acute pain, and Casgevy, a gene editing therapy for two rare blood-related disorders. It could also get regulatory approval for povetacicept, an investigational medicine for IgA nephropathy, by the end of November. It boasts several other pipeline programs as well and should earn additional approvals and label expansions over the next few years.
In the meantime, Vertex Pharmaceuticals' core business should continue driving strong financial results. In other words, the company's long-term prospects look increasingly strong, as it rides the success of its CF business and launches new products. The bottom line: Vertex is a top biotech stock to buy.
KING OF PRUSSIA, Pa., July 14, 2026 (GLOBE NEWSWIRE) -- Vertex, Inc. (NASDAQ:VERX), a leading provider of enterprise compliance technology for global commerce, today announced that it will release second quarter 2026 financial results after the market close on Monday, August 3, 2026. A conference call to discuss the results will be held at 5:00 p.m. Eastern Time that same day.
Those wishing to participate should register in advance for the live event at https://vertex-earnings-q2-2026.open-exchange.net/registration.
A live webcast of the event will also be available at the company’s investor relations website at https://ir.vertexinc.com. An audio-only replay of the conference call will be available on the investor relations website for one year.
About Vertex
Vertex, Inc. is a leading provider of tax and compliance technology for global commerce, combining deep domain expertise with advanced technologies and responsible AI to help businesses transact, comply, and grow with confidence. Powered by AI-driven tax automation, Vertex enables global enterprises to manage complex tax workflows with greater speed, accuracy, and agility. Headquartered in North America, and with offices in South America and Europe, Vertex empowers the world’s leading brands to simplify the complexity of continuous compliance.
For more information, visit www.vertexinc.com or follow us on X and LinkedIn.
Investor Relations contact:
Joe Crivelli
Vertex, Inc. [email protected]
When a company acquires another business, there's often going to be a premium involved, especially if it's in good shape or has some promising assets in its portfolio. But normally, you don't see a company pay double what its current valuation is.
That's what Vertex Pharmaceuticals (VRTX 1.00%) recently did when it announced a $10 billion purchase of Crinetics Pharmaceuticals (CRNX +0.10%), a company that specializes in endocrine disorders and diseases. Vertex agreed to pay a 102% premium for the stock, slightly more than double its valuation. While it was great news for Crinetics investors, it didn't sit all that well with Vertex investors, and the stock proceeded to fall sharply on the news.
Why did Vertex pay so much for the healthcare company?
Image source: Getty Images.
Management was "floored" by this one drug Vertex expects the assets it gets from Crinetics to add as much as $5 billion in revenue. And what really stood out to management was a particularly attractive drug: atumelnant. The drug isn't approved yet, but Vertex executives were thrilled with its progress in clinical trials as a treatment for congenital adrenal hyperplasia (CAH).
Atumelnant is a once-daily pill that has been well-tolerated in trials without serious adverse events and which helped bring patients' hormone levels back down to near normal levels. It has the potential to be a leading therapy for CAH, assuming it obtains approval.
"When we saw that data, we were floored. That is very, very important to this field."
"We are also excited by the significant potential of atumelnant to transform the treatment landscape for CAH, setting a new standard of care where patients do not have to choose between managing their excess adrenal androgens and enduring the side effects of high-dose steroids."
- Dr. Reshma Kewalramani, Vertex CEO
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Vertex remains a top growth stock to own The high price tag that Vertex paid for Crinetics stock may have alarmed investors, as shares of Vertex fell sharply on the news. Prior to the announcement on July 6, the stock was trading near its 52-week high at around $530, but would end up falling to just over $485 as of the end of last week. While it's not a huge sell-off, it does indicate that investors had a bit of initial apprehension when it was announced.
If, however, management is correct in assessing the value of the drugs it acquired and they do generate significant revenue and profit growth for Vertex, buying the stock today could prove to be a good move in the long run. Paying top dollar for quality assets can be necessary, and the good news here is that Vertex didn't have to take on debt to do the deal and is funding it via cash.
Overall, it looks like a good low-risk move for Vertex to make, reinforcing why it's an excellent growth stock to hold for the long run, as it's always looking for ways to expand.
Vertex Pharmaceuticals (VRTX 1.00%) has a robust business that centers around cystic fibrosis therapies. But its growth rate has been slowing down of late. And despite having a stellar pipeline and encouraging growth prospects, the stock's returns over the past year have been nominal.
Now, with the company announcing plans for a big $10 billion acquisition of Crinetics Pharmaceuticals (CRNX +0.11%), could that make the pharma stock a much better buy, perhaps even a no-brainer buy at its current valuation?
Image source: Getty Images.
The deal could inject a ton of growth into Vertex's business Crinetics is a company that develops treatments for endocrine diseases and disorders. This is a company that's still in its early growth stages, as last year its revenue totaled less than $8 million and its net loss was over $465 million.
But it has multiple promising assets in its portfolio, including Palsonify, which was approved last year to treat acromegaly, which is a hormonal disorder that can cause an enlargement of certain parts of the body. Atumelnant is not approved yet, but it is in the midst of clinical trials and is a treatment for congenital adrenal hyperplasia, which relates to multiple genetic conditions that impact the adrenal glands. Combined, these drugs could add $5 billion in annual revenue to Vertex's top line. The deal is expected to close fairly soon -- in the third quarter of this year.
That is significant given that last year, Vertex's revenue totaled $12 billion, which was an increase of nearly $1 billion, or about 9%, from the previous year. This acquisition could drastically grow its business.
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Should investors buy the dip on Vertex Pharmaceuticals? Despite the promising growth angle here, Vertex's stock has fallen after announcing the cash deal. That isn't entirely surprising, as the acquiring company normally sees its shares fall after a major acquisition, as investors may be concerned about the price paid for the business, the drag on earnings in the short term, and whether it will truly pay off. In short, it adds some risk.
However, with Vertex's management doing a great job of growing the business over the years and raking in some strong profits, it appears to be a well-calculated move. The healthcare stock is a bit expensive, trading at 29 times its trailing earnings, but given how much more diverse the business has become and its enhanced growth prospects, it could be a no-brainer buy on weakness right now, particularly for long-term investors.
Vertex’s Crinetics Deal Balances Growth with Integration RiskVertex Pharmaceuticals NASDAQ: VRTX said it has entered into a definitive agreement to acquire Crinetics Pharmaceuticals for $85 per share in cash, a transaction Vertex executives described as a strategic expansion into specialty endocrinology.
On a conference call announcing the deal, Vertex CEO and President Dr. Reshma Kewalramani said the transaction has a total equity value of about $10 billion, or $8.8 billion net of estimated cash acquired. She said Crinetics brings two lead endocrine assets that Vertex believes could generate more than $5 billion in combined peak annual sales: PALSONIFY, an approved oral therapy for acromegaly, and atumelnant, an investigational therapy in pivotal development for congenital adrenal hyperplasia, or CAH.
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CRISPR Therapeutics Gains After Earnings as Pipeline Hope Grows“Crinetics is an excellent strategic fit for Vertex,” Kewalramani said, citing the company’s focus on serious diseases, specialty markets, well-understood biology and potentially best-in-class medicines.
PALSONIFY Seen as Blockbuster Opportunity Kewalramani said PALSONIFY is the first and only once-daily oral therapy for adults with acromegaly, a rare hormonal disorder caused by excess growth hormone. She said the drug was launched in the U.S. in October 2025 and was more recently approved by the European Medicines Agency.
How Royalty Pharma Prints Cash Without Biotech's Biggest RisksVertex executives emphasized that many patients with acromegaly continue to need lifelong medical therapy after surgery. Kewalramani said current injectable somatostatin receptor ligands can be inconvenient, painful and associated with low patient compliance.
In Phase 3 data discussed on the call, Kewalramani said 83% of patients switching from injectable therapies maintained IGF-1 levels within the normal range on PALSONIFY, compared with 4% on placebo. In a separate study that included treatment-naive patients and others who had stopped prior treatment, 56% of PALSONIFY-treated patients achieved IGF-1 normalization, compared with 5% on placebo.
Duncan McKechnie, Vertex’s executive vice president and chief commercial officer, said PALSONIFY generated $10.3 million in net product revenue in the first quarter of 2026, based on data previously disclosed by Crinetics. He said the product achieved a 40% to 50% share of new-to-brand prescriptions in its second quarter of launch, with uptake across pituitary centers and community endocrinologists.
McKechnie said payer coverage currently stands at 60% through formal coverage or medical exceptions, and Crinetics has indicated it is on track to reach 75% coverage by the third quarter of 2026.
Atumelnant Positioned for CAH and Cushing’s Syndrome Vertex also highlighted atumelnant, a once-daily oral ACTH receptor antagonist currently enrolling patients in a Phase 3 CAH study. Kewalramani said classic CAH affects about 17,000 people in the U.S. and more than 15,000 outside the U.S.
She said patients with CAH require lifelong glucocorticoid therapy, often at high doses, to manage androgen excess. That creates what Vertex described as a dual burden: androgen-related complications and the long-term consequences of supraphysiologic glucocorticoid exposure.
McKechnie said Phase 2 data from the TouCAHn study showed a 67% reduction from baseline in mean A4 androgen levels, even as glucocorticoid dosing was tapered. He said 87% of patients achieved physiologic glucocorticoid dosing while A4 reduction was maintained.
“We believe atumelnant achieves the previously unattainable holy grail of CAH management,” McKechnie said, describing the ability to normalize androgen levels while allowing physiologic glucocorticoid dosing.
Kewalramani also pointed to potential use in ACTH-dependent Cushing’s syndrome, where atumelnant is in Phase 2 development. She said early study data showed rapid lowering of urine-free cortisol, including normalization in five of six patients in an 80 mg cohort while on physiologic glucocorticoid doses.
Financial Terms and Closing Timeline Charles Wagner, Vertex’s executive vice president and chief operating and financial officer, said Vertex expects to finance the acquisition with cash on hand and debt supported by $4.5 billion of fully committed bridge financing.
The transaction is subject to customary closing conditions, including approval by Crinetics shareholders and regulatory approvals. Vertex currently expects the deal to close in the third quarter of 2026.
Wagner said the acquisition is expected to have a modest impact on 2026 revenue and non-GAAP operating expenses, assuming the anticipated closing timeline. Vertex plans to provide updated 2026 guidance at closing. He added that the transaction is expected to be accretive to non-GAAP operating income in 2029.
Wagner said endocrinology will become Vertex’s fifth disease-area pillar, alongside cystic fibrosis, heme, acute pain and renal disease. He cited Vertex’s current marketed and pipeline products, including ALYFTREK, TRIKAFTA, CASGEVY, JOURNAVX and povetacicept, while saying Crinetics adds an on-market endocrine product and a pivotal-stage program.
Executives Address Deal Premium and Development Risks During the question-and-answer portion of the call, analysts asked about the transaction price, the peak sales outlook and safety considerations for atumelnant.
In response to a question from Michael Yee of UBS about the acquisition premium, Wagner said Vertex sees “a lot of intrinsic value” in Crinetics, pointing to the potential for best-in-class products and more than $5 billion in peak sales. He said the valuation was roughly 2 times peak sales, which he described as in line with other deals involving high-quality commercial or near-commercial assets.
Asked about liver safety for atumelnant, Kewalramani said Vertex reviewed the available data across CAH and ACTH-dependent Cushing’s syndrome. She said the company saw a handful of minor liver function test elevations, with no cases involving both liver function tests and bilirubin, and that most resolved without intervention while patients continued therapy.
Vertex executives said they do not expect the acquisition to change the company’s capital allocation strategy, which remains focused on internal and external innovation. Kewalramani said the timing of the deal reflects the availability of the company, the maturity of the data and Vertex’s view that it can support PALSONIFY’s global launch and prepare for atumelnant’s potential commercialization.
About Vertex Pharmaceuticals NASDAQ: VRTXVertex Pharmaceuticals Inc is a Boston-based biotechnology company focused on the discovery, development and commercialization of therapies for serious diseases. Founded in 1989, Vertex built its reputation on research-driven drug development and is best known for its work in cystic fibrosis (CF), where its portfolio of small-molecule CFTR modulators transformed standards of care for many people with the disease. The company operates research and development, manufacturing and commercial organizations and serves patients and healthcare systems in multiple international markets.
Vertex's marketed products center on CFTR modulators that target the underlying cause of cystic fibrosis rather than just treating symptoms.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Vertex Pharmaceuticals (VRTX 0.45%) is a biotech company that has steadily delivered growth to investors, thanks to its dominance in cystic fibrosis (CF) treatment. The company's portfolio of CF drugs has transformed the lives of patients and helped Vertex's earnings soar well into the billions of dollars. This is likely to continue as Vertex's solid intellectual property extends its leadership through at least the late 2030s.
And in recent years, Vertex has made moves to make this story even brighter. This is by broadening its presence into other areas, with launches of a gene editing treatment for blood disorders and a pain management drug. The company has also used acquisitions to grow, and this brings me to the recent $10 billion move.
Vertex this week announced its acquisition of Crinetics Pharmaceuticals (CRNX +0.16%), a company that may add $5 billion in peak annual revenue to Vertex's top line. With this deal taking shape, is Vertex a buy? Let's find out.
Image source: Getty Images.
Vertex's CF leadership First, let's take a look at Vertex's portfolio and general situation prior to the Crinetics move. As mentioned, the biotech is the global CF leader, specializing in CFTR modulators. These therapies correct the malfunctioning protein that causes symptoms of the disease. Since genetic mutations result in different problems with the protein, one CFTR modulator may not work for every patient. But Vertex's top drugs, Alyftrek and Trikafta, cover a lot of territory: They have the potential to treat more than 90% of the CF population.
Meanwhile, the company continues to work on possible treatments, in partnership with Moderna, for patients who can't be treated by the company's CFTR modulators. And Vertex is also developing its next generation of CF therapies. Considering the company's expertise in this area and deep pipeline, there's reason to be optimistic about leadership lasting well into the future -- and fueling steady growth. And an advancing pipeline in serious rare diseases, as well as the more common area of pain, should further bolster growth over the long run.
This expansion into other treatment areas is already bearing fruit. Earlier this year, the biotech predicted that non-CF products would contribute at least $500 million to 2026 revenue. The company has established a long track record of growth, with revenue climbing more than 600% over the past decade to $12 billion in the latest full year. And profit has also advanced, reaching more than $3 billion.
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A recently approved drug Now, let's consider the Crinetics move. Vertex is buying the company, which offers it access to the recently approved Palsonify for acromegaly, a chronic disorder caused by the overproduction of growth hormone. About 20,000 Americans are living with this disorder today. Palsonify could stand out because it's the first daily, oral treatment -- a more convenient option than the current infusions. The companies say early uptake of the drug has been strong.
Along with a pipeline of candidates and research, the deal also gives Vertex phase 3 asset atumelnant for congenital adrenal hyperplasia (CAH). The disorder, impacting 17,000 people in the U.S., involves excess androgen production that results in a variety of serious symptoms. Atumelnant could reshape the treatment landscape for this disease and also holds potential to treat Cushing's syndrome.
Together, these treatments may bring in peak revenue of $5 billion, and Vertex says this would support its goal of producing sustained revenue growth in the double digits.
Vertex is paying $10 billion, or $85 per share, in an all-cash deal. This is two times the projected peak sales figure -- and this level of sales isn't necessarily guaranteed since atumelnant hasn't yet reached the regulatory approval stage. So, this isn't a dirt cheap price, and the intended goals aren't guaranteed. This means some risk is involved.
Still, it's a fair price considering the strength of the late-stage pipeline and a wise move for Vertex as Crinetics fits nicely into its portfolio. Crinetics' specialty in rare endocrine disorders resembles Vertex's focus on CF: Both companies prioritize serious diseases within a specialty area and with significant unmet need. And these diseases involve well-understood biology that may be targeted to transform their treatment. Vertex is also entering this story at the right time, shortly after the Palsonify launch, so that it may apply its commercialization expertise early on. And this adds an important new specialty area to the Vertex portfolio.
Though this deal may not generate enormous results overnight -- it's expected to be accretive to non-GAAP operating income in 2029 -- I think it's worth the wait. And that makes Vertex a fantastic biotech growth stock to buy and hold.
On Monday, Crinetics and Vertex entered into a definitive agreement under which Vertex will acquire Crinetics for $85 per share in cash, representing a total equity value of approximately $10 billion.
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Vertex Pharmaceuticals NASDAQ: VRTX recently announced its plans to acquire Crinetics Pharmaceuticals NASDAQ: CRNX for $10 billion. The deal, which has already been approved by the board of directors of both companies, is expected to close in the third quarter of 2026.
Vertex Pharmaceuticals Today
VRTX
Vertex Pharmaceuticals
$522.25 -7.34 (-1.39%)
As of 07/7/2026 04:00 PM Eastern
52-Week Range$362.50▼
$533.67P/E Ratio30.98
Price Target$557.09
Vertex will pay $85 per share in cash for a total equity value of approximately $10 billion, or approximately $8.8 billion net of estimated cash acquired. Vertex expects to finance the acquisition using a combination of cash on hand and debt.
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At the time of the announcement, CRNX was trading at around $42 per share. Vertex is willing to pay a $85 per share premium for the company's pipeline depth outside its core cystic fibrosis (CF) franchise. The Crinetics pipeline will also strengthen Vertex’s position in specialty therapeutics.
Investors liked what they heard, with CRNX up around 98% immediately after the announcement. The larger question is what the deal means, and doesn’t mean, for the broader biotech sector.
Big Pharma Will Still Pay Up for De-Risked Biotech AssetsDeals like this are not uncommon in the biopharmaceutical space. Companies like Crinetics assume the risk of moving a drug through the clinical trial stage (sometimes with the financial backing of a larger biotech company). Then, when regulatory approval is granted, or is a near certainty, a company like Vertex buys the company for access to its pipeline.
In this case, Vertex has been looking to expand beyond its leadership role in the CF space. But drug development is time-consuming and expensive. That’s why it was willing to pay a premium for Crinetics, which has enticing, de-risked assets.
What Does Crinetics Add to the Vertex Portfolio?Immediately, Vertex will start to see revenue from PALSONIFY. This is the only once-daily oral therapy for adults with acromegaly, a rare and debilitating condition caused by a pituitary tumor that secretes growth hormone. There are an estimated 20,000 cases in the United States as of this writing.
Crinetics received U.S. Food and Drug Administration (FDA) approval for PALSONIFY in September 2025. The drug was also recently approved by the European Medicines Agency (EMA) and is under review by other global regulatory bodies. Since its approval and launch, PALSONIFY has shown strong demand across all patient segments, prescribing activity expansion, and—crucially—growing reimbursement coverage.
Crinetics also has an advanced pipeline candidate, Atumelant, a once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist for treatment of congenital adrenal hyperplasia (CAH). The drug is currently in Phase 3 development.
Classic CAH is a rare, chronic genetic condition affecting the adrenal glands, and there are significant unmet needs. The most severe form of the disease impacts 17,000 patients in the United States. In the Phase 2 study, Atumelnant was generally well tolerated with no treatment-related severe or serious adverse events to date.
What This Deal Doesn’t Say About the Biotech TradeMany analysts are forecasting a breakout in the biotech sector. There are several reasons for this belief:
Patent cliffs at large pharmaceutical companies
Depressed biotech valuations
Cash-rich balance sheets
Pipeline productivity concerns
Vertex has a long patent runway for its cystic fibrosis portfolio. CASGEVY (developed in partnership with CRISPR Therapeutics NASDAQ: CRSP) and JOURNAVX, which provide exposure to gene therapy and non-opioid pain medication, have only recently been approved, so there’s plenty of runway.
Trading at around 31x earnings, VRTX is trading at a premium to its historic average and right around the S&P 500 average as of July 7. Plus, as of March 31, Vertex’s trailing 12 month (TTM) free cash flow was $3.71 billion. That’s healthy, but the company has had volatility with FCF over the last five years.
That leaves pipeline concerns. While it’s not fair to say that Vertex is concerned about the depth of its pipeline, this acquisition does help with the breadth. Having treatments in endocrinology will be the company’s fifth major business pillar to go with cystic fibrosis, hematology, pain, and renal therapies.
Current Price$522.25High Forecast$641.00Average Forecast$557.09Low Forecast$436.00Vertex Pharmaceuticals Stock Forecast Details
Here’s where investors should be watching closely. The Vertex analyst forecasts on MarketBeat don’t indicate that analysts have rerated or repriced VRTX since the announcement.
However, H.C. Wainwright maintains its Buy rating with a Street-high $641 price target. That’s 15% above the consensus price target as of July 7.
The company’s earnings are coming up on August 3, and analysts may be waiting to hear what management says on the earnings call before reconsidering their outlook. But the strategic fit is clear. Vertex is buying its way into the rare disease space, but it’s a purchase that investors believe will pay off for shareholders.
Should You Invest $1,000 in Vertex Pharmaceuticals Right Now?Before you consider Vertex Pharmaceuticals, you'll want to hear this.
MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Vertex Pharmaceuticals wasn't on the list.
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In the latest big-ticket deal in the pharmaceutical industry, Vertex Pharmaceuticals (VRTX 1.31%) and Crinetics Pharmaceuticals (CRNX +98.74%) announced in a joint press release that Vertex is acquiring Crinetics. This won’t come cheap, to put it mildly; it’s a premium-priced deal that will cost billions of dollars. Here’s a look at whether that’s likely to be capital well spent.
Quite a pricey premiumVertex is paying $85 per share to acquire Crinetics, to be paid entirely in cash. This values the latter pharmaceutical company at approximately $10 billion, or roughly $8.8 billion when accounting for the cash and short-term investments Crinetics has on hand. As for the per-share price, $85 is slightly more than double the level at which Crinetics closed on Monday.
Image source: Getty Images.
The boards of directors at both companies have unanimously approved the deal, which is expected to close in the third calendar quarter of this year.
Vertex is buying a company that recently earned its first Food and Drug Administration (FDA) approval. This was for its Palsonify, a treatment for the rare endocrine disorder acromegaly (characterized by excessive growth hormone production). This medication was greenlit by the regulator last September for adult use, and since it’s currently the only approved acromegaly treatment administered as a once-daily pill (as opposed to a monthly injection), it has quite a strong position in the market — in its first full quarter following approval, the drug brought in $10.7 million in revenue.
Palsonify was also approved for the same indication by the 27-country European Union’s European Commission at the end of this past April.
Crinetics also has a pipeline distinguished by one standout drug candidate in particular. This is atumelnant, which targets the most severe form of congenital adrenal hyperplasia (CAH), an affliction of the adrenal glands. While this disorder is rarer than acromegaly, it has a significant unmet medical need — meaning that if it comes to market, it’ll have excellent sales potential from the start. That might not be too far in the future, as the drug is currently in late Phase 3 clinical development.
Other pipeline drugs in Crinetics lab target afflictions such as hyperparathyroidism, Graves’ disease, diabetes, and obesity, with the latter a durably hot segment of the pharmaceutical market.
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Immediate return on investmentIn the press release, the two companies quoted Vertex CEO Reshma Kewalramani as saying that his company “can build on the strong momentum of the Palsonify launch by applying our experience in commercializing medicines for rare genetic diseases.”
He added that “we are also excited by the significant potential of atumelnant to transform the treatment landscape for CAH.”
His company clearly believes owning Crinetics will produce immediate results thanks to the latter company’s already-popular commercialized drug. It described atumelnant as a product with multi-billion dollar potential if it can also earn approval for another affliction, Cushing’s syndrome (a hormonal disorder that arises from over-exposure to cortisol). So we can assume management feels that $10 billion is a reasonable price for the investigational drug alone.
Together, Palsonify and the potentially dual-indication atumelnant could bring in $5 billion in annual sales for the Crinetics-owning Vertex.
Future blockbusters?In short, Vertex could eventually have in its portfolio not one but two blockbuster drugs (i.e., those that generate at least $1 billion in annual sales). It’s got plenty of cash in its coffers, with over $5.5 billion in greenbacks as of the end of March. It’s also secured a $4.5 billion bridge loan from lenders Bank of America (BAC 0.07%) and Morgan Stanley (MS 0.03%).
I think this is a bold and impressive move by Vertex, which gives the company, at the very least, an already-strong commercialized product with Palsonify, despite the fairly limited size of the product’s addressable market. So far, it looks like atumelnant has similar potential and could even be the company’s No. 1 if it’s ultimately approved for both desired indications. This deal is definitely worth it, in my view, despite the gasp-inducing price tag and monster premium to Crinetics’ share price.
Vertex Pharmaceuticals (VRTX 1.31%) is making its biggest bet in years. On Monday, the company agreed to acquire Crinetics Pharmaceuticals (CRNX +98.74%) for $85 per share in cash. That works out to a total equity value of about $10 billion, or roughly $8.8 billion net of the cash Crinetics holds. Both companies' boards approved the deal unanimously, and Vertex expects it to close in the third quarter of 2026.
For a company that has spent decades built almost entirely around cystic fibrosis, this is a meaningful step into a new disease area. Here's what the deal buys, how Vertex is paying for it, and whether the price looks reasonable.
Image source: Getty Images.
What Crinetics brings Perhaps the biggest asset Crinetics brings is a drug called PALSONIFY -- the first and only once-daily oral therapy approved for adults with acromegaly. It won U.S. approval in September 2025 and was recently cleared in Europe. Vertex says its early launch has shown strong demand across patient groups. Until PALSONIFY arrived, most patients relied on large-needle injectable treatments, so an oral option fills a real gap.
Behind it sits atumelnant, a once-daily oral drug in late-stage development for congenital adrenal hyperplasia, another rare endocrine condition. The drug has also shown early promise in Cushing's syndrome.
Together, Vertex says these assets boast more than $5 billion in combined annual peak-sales potential.
Crinetics notably also brings a drug-discovery platform focused on endocrine diseases -- a pipeline of earlier-stage programs, and intellectual property protection that extends into the 2040s.
How Vertex is paying for it This is an all-cash deal, and Vertex isn't paying entirely out of pocket. The company plans to fund the purchase with a mix of cash on hand and debt, supported by $4.5 billion of fully committed bridge financing from Bank of America and Morgan Stanley.
Vertex can afford it. The company held about $13 billion in cash and marketable securities at the end of the first quarter, and its base cystic fibrosis business keeps generating substantial cash. First-quarter revenue rose 8% year over year to about $3 billion, and the company reaffirmed full-year guidance of roughly $13 billion. Layering some debt on top to close a $10 billion acquisition is well within reach for a company generating this kind of recurring cash flow.
It helps that Vertex isn't overleveraging itself. The bridge financing is meant to be temporary, refinanced over time rather than left on the balance sheet as permanent leverage. In other words, this is a well-capitalized business adding to its portfolio.
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Whether the price is disciplined Here's the part that matters most for Vertex shareholders. At $85 per share and more than $5 billion in combined peak-sales potential, Vertex is paying about two times peak sales. And peak sales, by definition, are years away and far from guaranteed. Atumelnant is still in trials, and even PALSONIFY's launch is only a few quarters old.
Vertex acknowledges the timeline. It expects the deal to become accretive to non-GAAP (adjusted) operating income only in 2029, though it says PALSONIFY's ongoing launch should start adding to revenue right away.
Even so, there is a solid case that the price is fair. Vertex isn't a serial acquirer reaching outside its expertise. It's buying assets that fit its stated strategy of targeting serious diseases with well-understood biology, small commercial footprints, and high unmet need. That is the same profile that made its cystic fibrosis franchise so profitable. The deal also solves a real problem. Vertex needs growth engines beyond cystic fibrosis, and building a new specialty franchise from scratch would take far longer than buying one with an approved, launching drug.
So, is this a smart deal for Vertex?
Overall, I think it's a reasonable one. But the company is paying full price for assets whose biggest payoffs are still ahead. That said, Vertex is buying under a strategy it knows well, using a balance sheet that can absorb the cost, and addressing its diversification needs in a single move. So, for a business that has long needed a second act, paying up for a new growth pillar looks like a solid idea. Now we just need the pipeline to deliver.
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second quarter 2026 financial results on Monday, August 3, 2026, after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (833) 630-2124 (U.S.) or +1 (412) 317-0651 (International) and reference the “Vertex Pharmaceuticals Second Quarter 2026 Earnings Call.”
The conference call will be webcast live and a link to the webcast can be accessed through Vertex's website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company's website.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.
Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.
Crinetics Pharmaceuticals shares surged after Vertex Pharmaceuticals announced an agreement to acquire the endocrinology-focused biotech company in a deal valued at approximately $10 billion.
The all-cash transaction values Crinetics at $85 per share and is expected to close during the current quarter, subject to customary conditions.
The acquisition sparked a sharp rally in CRNX stock.
CRNX shares climbed nearly 100% in pre-market trading on Tuesday to around $83.69.
Vertex shares, meanwhile, declined modestly following the announcement.
The transaction comes amid a wave of pharmaceutical industry acquisitions, as large drugmakers seek to strengthen their development pipelines by acquiring smaller biotechnology companies with promising therapies.
According to a joint press release, Vertex expects Crinetics' portfolio, including its approved acromegaly treatment Palsonify and investigational therapy Atumelnant, to contribute an estimated $5 billion in peak annual sales.
Crinetics focuses on therapies for endocrine disorders.
The company markets Palsonify, a once-daily oral treatment approved by the US Food and Drug Administration in September for acromegaly, a rare hormonal disorder caused in most cases by a noncancerous pituitary gland tumour that leads to excessive growth hormone production during adulthood.
The disease can result in enlargement of the face, jaw, hands, and feet, along with symptoms including joint pain, headaches, and nausea.
Crinetics said Palsonify works by lowering insulin-like growth factor to help alleviate these symptoms.
The company's pipeline also includes Atumelnant, a once-daily oral treatment under development for congenital adrenal hyperplasia (CAH), a group of inherited disorders affecting the adrenal glands.
The condition leads to excessive production of male sex hormones known as androgens.
Patients with CAH are commonly treated with high-dose glucocorticoids, which are associated with multiple side effects.
Crinetics is developing Atumelnant as an alternative treatment approach.
The company also said the therapy has demonstrated potential in treating Cushing's syndrome, a rare hormonal disorder characterised by excessive cortisol levels that can cause rapid weight gain, muscle weakness, bruising and high blood pressure.
Vertex Chief Executive Officer Reshma Kewalramani described the acquisition as strategically aligned with the company's long-term growth plans.
"Its focus on serious diseases in specialty markets with significant unmet need, well-understood causal human biology, and potentially best-in-class medicines could deliver transformative benefit to patients," she said in a statement.
Kewalramani added that Vertex intends to build on its experience in rare genetic diseases to continue expanding the commercial potential of Palsonify.
Vertex has established its business around treatments for cystic fibrosis and has also expanded into gene-editing therapies through its partnership with CRISPR Therapeutics.
Crinetics closed at slightly above $42 per share before the announcement, meaning Vertex's offer represents a premium of more than 100%.
According to the companies, the acquired portfolio could generate approximately $5 billion in peak annual sales.
Vertex reported total revenue of $12 billion last year, making the acquisition a significant addition to its long-term growth strategy.
Market analysts also viewed the strategic rationale positively.
Citi analyst Geoff Meacham said the acquisition aligns well with Vertex's existing strengths in specialty diseases and biologically targeted medicines.
"The fit is clear, given existing expertise in specialty markets, serious diseases, causal biology, and measurable biomarkers. The $5 billion peak sales framing adds another route to sustain double-digit topline growth."
Meacham maintained a Buy rating on Vertex and set a price target of $585, indicating further upside from the stock's previous closing level.
Vertex expects to finance the acquisition using a combination of cash on hand and debt, supported by $4.5 billion of fully committed bridge financing.
Vertex’s cash, cash equivalents, and total marketable securities as of March 31, 2026, were $13.0 billion.
The transaction was approved by both the Vertex and Crinetics Boards of Directors and is anticipated to close in the third quarter of 2026.
Palsonify And Atumelnant Expand Vertex’s Rare Disease Portfolio"Crinetics is an excellent strategic fit for Vertex," said Reshma Kewalramani, CEO and President of Vertex.
Crinetics’ marketed medicine, Palsonify (paltusotine), received FDA approval in September 2025.
The European Medicines Agency recently approved Palsonify.
It is the first and only once-daily oral therapy for adults with acromegaly, a rare and debilitating condition caused by a pituitary tumor that secretes excess growth hormone, which affects an estimated 20,000 diagnosed people in the U.S.
Crinetics’ most advanced pipeline candidate, atumelnant, is a once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist currently in Phase 3 development for congenital adrenal hyperplasia (CAH).
Classic CAH, the most severe form of the disease, with 17,000 addressable patients in the U.S., is a rare, chronic genetic condition affecting the adrenal glands.
In Phase 2 studies, patients taking atumelnant were able to achieve near normalization of excess androgen levels on physiologic replacement doses of glucocorticoids.
Vertex Expects Revenue And Profit Growth From AcquisitionThe transaction is expected to contribute immediately to Vertex’s revenue growth via the ongoing launch of Palsonify, which has blockbuster potential in acromegaly.
Longer term, atumelnant has the potential to be a multi-billion-dollar opportunity in CAH, with additional upside from its potential in Cushing’s syndrome.
At peak, these assets have the potential to deliver more than $5 billion in combined annual revenue, which will further Vertex’s goal of delivering sustained double-digit revenue growth, in addition to operating margins.
The transaction is expected to become accretive to adjusted operating income in 2029.
Analyst Sees UpsideWilliam Blair on Monday wrote, "…it is the first time we have heard of a multi-billion dollar sales potential for a CAH product."
Analyst Myles Minter further added that the deal is on the higher side on a stock price premium basis, but views this as reasonable if the peak sales number can be achieved.
William Blair also wrote, "Based on management commentary, we believe significantly more of the >$5 billion peak sales potential is weighted toward the atumelnant opportunity, which carries more risk given the late-clinical-stage nature of the ACTH receptor antagonist."
Price Action: Crinetics Pharmaceuticals shares were up 98.88% at $83.59, and Vertex Pharmaceuticals shares were down 0.30% at $528.00 during premarket trading on Tuesday, according to Benzinga Pro data.
Photo: courtesy of Vertex
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Robinhood, Dell Lead 5 Stocks Near Buy Points With AI Tailwinds Crinetics stock nearly doubled late Monday after Vertex Pharmaceuticals pledged $10 billion to buy the endocrinology-focused biotech company. The smaller company sells Palsonify, a treatment for acromegaly, and is working on a treatment for congenital adrenal hyperplasia, or CAH, called atumelnant. Both drugs are daily pills and, together with the rest of Crinetics Pharmaceuticals' (CRNX) pipeline, would add an estimated…
The acquisition would add to Vertex's pipeline and potentially grow its annual revenue by $5 billion with the addition of Crinetics-developed drugs Palsonify and Atumelnant, the company said.
When a stock hits a 52-week high, that's a great sign the business is doing well. And when it hits a new all-time high, then you know the market is really excited about what's ahead for the business. But at the same time, there can also be concerns that its valuation is getting too steep, and that there may be plenty of downside risk.
Vertex Pharmaceuticals (VRTX +0.27%) is a top healthcare company and a leader in cystic fibrosis treatments. Its stock has been doing exceptionally well this year, with gains of around 17%, far above the S&P 500's returns of about 10% thus far. And amid the rise in value, the stock has hit a new all-time high. Is it too late to buy shares of Vertex, or could there still be more gains ahead?
Image source: Getty Images.
Investors are hopeful for much more growth ahead for Vertex In its most recent earnings results, Vertex's numbers didn't look all that impressive; the pharma company's sales were up just 8%, totaling roughly $3 billion for the period ending March 31. And its growth rate has been declining in recent years.
But the hope for investors is that in the long run, there may be much more growth to come, with gene therapy Casgevy still in its early rollout. Non-opioid pain medication Journavx was also approved just over a year ago, and thus, Vertex still has some levers to pull on to drive its growth rate higher in the future. Plus, it has many ongoing trials that could unlock many more opportunities in the future.
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Is Vertex's stock still worth buying right now? Vertex is currently trading at around 31 times its trailing earnings, which is far higher than the S&P 500 average of 25. Even based on the company's expected future earnings, the stock may be a bit expensive as its price-to-earnings-growth (PEG) multiple is around 2.0, which factors in the growth that analysts expect from the business over the next five years. When a stock's PEG is around 1.0 or lower, it's considered a good buy, but with Vertex being well above that, this may be a sign that there may be too much future growth already priced into the stock's value right now. It may rise higher, but it may also be approaching a peak.
Although Vertex's business looks promising and it has plenty of growth potential, it's not a stock I'd buy today because of its high valuation, as that can drastically impact future returns. There are better and more reasonably priced growth stocks to choose from today.
BOSTON & SAN DIEGO--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases, today announced that the companies have entered into a definitive agreement under which Vertex will acquire Crinetics for $85.00 per share in cash, for a total equity value of approximately $10.0 billion, or approximately.
A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston, Massachusetts, U.S., October 23, 2019. REUTERS/Brian Snyder/File Photo Purchase Licensing Rights, opens new tab
CompaniesJuly 6 (Reuters) - Vertex Pharmaceuticals (VRTX.O), opens new tab will buy Crinetics Pharmaceuticals (CRNX.O), opens new tab for a total equity value of about $10 billion, the companies said on Monday.
Shares of Crinetics more than doubled in extended trading, while those of Vertex were marginally down.
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The acquisition gives Vertex access to Palsonify, which was approved by the U.S. Food and Drug Administration in September 2025 to treat adults with acromegaly, a rare hormonal disorder caused by excess growth hormone. The companies said the once-daily oral therapy has shown early commercial momentum since launch.
Crinetics’ experimental drug, atumelnant, is in late-stage development for congenital adrenal hyperplasia, or CAH, a rare genetic disorder affecting the adrenal glands.
The companies said Palsonify and atumelnant could together generate more than $5 billion in peak annual sales. Vertex expects the deal to add immediately to revenue growth and become accretive to non-GAAP operating income in 2029.
Vertex will pay $85 per Crinetics share, the companies said, with the deal expected to close in the third quarter of 2026.
Reporting by Puyaan Singh in Bengaluru; Editing by Jonathan Ananda
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Key Takeaways Vertex gained FDA approval to expand Casgevy to patients aged two and older with SCD or TDT.VRTX's Casgevy is the first genetic therapy approved for children as young as two with both disorders.VRTX said label expansion applications remain under review in the United Kingdom and Saudi Arabia. Vertex Pharmaceuticals (VRTX - Free Report) announced that the FDA has approved its one-shot gene therapy, Casgevy (exagamglogene autotemcel), for the treatment of individuals aged two years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent beta thalassemia (TDT).
Following the latest nod, Casgevy became the first and only genetic therapy to be approved for treating children as young as two years for both severe SCD and TDT, both inherited blood disorders.
Regulatory filings seeking approval for the label expansion of Casgevy are currently under review in the United Kingdom and the Kingdom of Saudi Arabia for the given indication.
Casgevy was previously approved for treating SCD and TDT in patients aged 12 years and older.
VRTX’s Price PerformanceYear to date, shares of Vertex have rallied 9.8% compared with the industry’s increase of 7%.
Image Source: Zacks Investment Research
More on VRTX’s Ongoing Activities With CasgevyWe remind investors that Vertex leads the global development and commercialization of Casgevy under the terms of the 2021 agreement, with support from CRISPR Therapeutics (CRSP - Free Report) .
Per the collaboration agreement, Vertex splits the program costs and profits in a 60:40 ratio with CRISPR Therapeutics.
In the first quarter of 2026, Casgevy’s sales were $42.9 million, down from $54.3 million recorded in the fourth quarter of 2025 due to quarter-to-quarter variability in Casgevy infusions.
Nonetheless, Casgevy’s launch metrics look positive with growing cell collections and product infusions. Vertex is also making rapid progress in the drug’s access and reimbursement.
In May 2026, Vertex signed a reimbursement agreement with Germany’s GKV-Spitzenverband for Casgevy, ensuring sustainable patient access for eligible individuals aged 12 years and older with severe SCD or TDT.
In 2026, Vertex expects continued quarter-to-quarter variability in Casgevy infusions, which the company expects will smooth out in 2027 and beyond. If commercialization of Casgevy ramps up successfully over the next few years, Vertex Pharmaceuticals believes the therapy has multibillion-dollar commercial potential.
VRTX Zacks Rank & Stocks to ConsiderVertex currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 8.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $3.02, while estimates for 2027 have increased from $2.91 to $4.92 during the same time. LQDA shares have surged 130% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston, Massachusetts, U.S., October 23, 2019. REUTERS/Brian Snyder/File Photo Purchase Licensing Rights, opens new tab
CompaniesJuly 1 (Reuters) - The U.S. Food and Drug Administration approved expanded use of Vertex Pharmaceuticals' (VRTX.O), opens new tab gene therapy in children as young as two with inherited blood disorders, including sickle cell disease, the first such treatment cleared for this age group.
Casgevy, a one-time treatment made from a patient's own blood stem cells, was previously approved for patients aged 12 and older with sickle cell disease or transfusion-dependent beta thalassemia.
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Here are further details: -
Sickle cell disease is a painful, inherited blood disorder in which the body makes sickle-shaped hemoglobin, preventing red blood cells from properly carrying oxygen to the body's tissues.
In a trial of children aged five to under 12 with sickle cell disease, all eight evaluable patients had no severe vaso-occlusive crises or painful episodes for at least 12 straight months within the first 24 months of infusion.
In beta thalassemia, eight of nine evaluable children achieved transfusion independence for 12 consecutive months, with a median duration of 20.1 months.
The FDA granted approval to Vertex in 53 days after filing under the Commissioner's National Priority Voucher, its new fast-track program designed to shorten review time for a drug application.
In 2023, the FDA approved Vertex's and Genetix Biotherapeutics' gene therapies for sickle cell disease in patients 12 years and older.
Other long-term treatment options for sickle cell disease include bone marrow transplant, which requires matching donors, and the chemotherapy drug hydroxyurea.
Reporting by Puyaan Singh in Bengaluru; Editing by Vijay Kishore
Our Standards: The Thomson Reuters Trust Principles., opens new tab
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved expanded use of CASGEVY® (exagamglogene autotemcel) for the treatment of people ages 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent beta thalassemia (TDT). CASGEVY is the first approved genetic therapy indicated for children as young as 2 years for both SCD and TDT.
Choosing between a high-growth clinical-stage player and an established industry titan can be difficult for investors. This comparison examines Dyne Therapeutics (DYN 1.24%) and Vertex Pharmaceuticals (VRTX +0.22%) to help you determine the better buy.
Dyne focuses on delivering targeted nucleic acid medicines to muscle tissue using its proprietary delivery platform. Vertex is the global leader in cystic fibrosis treatment and is now diversifying its pipeline into new areas like acute pain and sickle cell disease. Both companies operate in the high-stakes world of biotechnology but represent different levels of corporate maturity.
The case for Dyne TherapeuticsDyne Therapeutics is a clinical-stage company among biotech stocks that aims to treat rare, genetically driven diseases through its proprietary FORCE platform. It is currently developing therapies for conditions like Duchenne muscular dystrophy and myotonic dystrophy type 1, which have high unmet medical needs. Because the company is still in the development phase, it currently has no commercial customers and relies on external capital to fund its research.
In FY 2025, Dyne had no revenue because the company is still testing its lead drug candidates and has no products on the market. This lack of sales resulted in a net loss of $446.2 million for the year. This loss was wider than the $317.4 million net loss reported in the prior fiscal year, largely due to higher clinical trial and laboratory costs.
The current debt-to-equity ratio stands at approximately 0.2x. A current ratio measures a company's ability to pay short-term obligations, indicating its liquidity strength to fund future trials. Free cash flow was negative at approximately $405.1 million in FY 2025.
Vertex Pharmaceuticals is a powerhouse in the medical sector, known for its dominant position in cystic fibrosis treatments. Its product portfolio includes blockbuster drugs that are distributed primarily through a limited number of specialty pharmacies and wholesalers. Beyond its core niche, the company is actively diversifying into new therapeutic areas, such as acute pain and type 1 diabetes, to ensure long-term growth.
In FY 2025, revenue reached $12 billion, representing a year-over-year increase of nearly 10%. The company reported net income of nearly $4 billion, resulting in a net margin of approximately 32.7%. Net margin indicates how much of every dollar in revenue actually becomes profit after all expenses, and the company's P/S ratio, which compares its stock price to its total sales, reflects its market standing.
Its current debt-to-equity ratio is approximately 0.1x. This ratio compares total debt to shareholder equity, and a lower number indicates a conservative approach to borrowing. Free cash flow for FY 2025 was close to $3.2 billion. Free cash flow is the cash a company generates after accounting for the money spent to maintain or expand its asset base.
Risk profile comparisonFinancial sustainability remains a primary concern for Dyne Therapeutics, given the company’s history of significant operating losses. It depends on a loan agreement with Hercules Capital that includes strict financial covenants, which could restrict its operations if its cash reserves fall too low. Additionally, its drug candidates are in early clinical stages, which means there is a high risk of failure to demonstrate safety or efficacy during trials.
Vertex Pharmaceuticals faces significant revenue concentration because its business is heavily dependent on its cystic fibrosis portfolio. Any safety issues or new competition from large peers such as AbbVie Inc. (ABBV 0.19%) could materially harm its financial results. The company also deals with global pricing pressures from government cost-containment efforts and ongoing intellectual property litigation involving ToolGen related to gene-editing technology.
Valuation comparisonVertex Pharmaceuticals trades at a premium reflecting its profitability, while Dyne Therapeutics has no sales or earnings expected in 2026 to base ratios on.
MetricDyne TherapeuticsVertex PharmaceuticalsSector BenchmarkForward P/En/a26x24.8xP/S ration/a10.3xSector benchmark uses the SPDR XLV sector ETF.
Valuation metrics sourced from Financial Modeling Prep (FMP) and may differ from other data providers.
Which stock would I buy in 2026?These are two companies at different stages of their pharmaceutical life.
Dyne Therapeutics may not have revenue, but its $3.7 billion market cap is a sign of investors’ faith in the business. Dyne is preparing its first product for Duchenne Muscular Dystrophy to enter the market in the first quarter of fiscal 2027, with its second product, DM1, planned for a year later.
Long-term revenue projections are inherently more speculative, but analysts see Dyne making $53 million in sales in 2027 and $277 million in 2028, and reaching well over $1 billion in 2030. That’s a great outlook.
Vertex, meanwhile, is building on its dominant position in cystic fibrosis treatment, investing heavily in research and development. In just a few years, Vertex has expanded its CF drug treatments so it now could treat 95% of all CF patients in the U.S. Approvals in other markets are coming through, which means the market for its existing drugs continues to expand. The company is also deep in trials for a drug to treat conditions that lead to renal failure, a new market for Vertex. The U.S. has accelerated approval for povetacicept in IgA nephropathy, a treatment that would be a blockbuster ($1 billion-plus in lifetime sales) if approved.
Dyne is a very promising company that looks on track to generate revenue next year. But Vertex continues to be a fast grower, with Wall Street seeing sales grow more than $1 billion this year to over $13 billion, with nearly $4.5 billion net income. With an expanding market, heavy R&D, and a decent price-to-forward earnings ratio, Vertex gets the nod.
Vertex Pharmaceuticals Incorporated maintains a dominant, monopoly position in cystic fibrosis, driving highly predictable, recurring revenue and justifying its valuation premium. VRTX is leveraging its CF cash flows to expand into pain, hematology, and renal franchises, with promising catalysts in each area, notably Pove for IgAN. Non-CF franchises are gaining traction, with Journavx and Casgevy contributing to revenue growth; renal (Pove) is positioned to become a major driver post-2027.
Starting the week on an auspicious note, Vertex (VERX +1.23%) stock is rising this morning. Shares of the software company are bouncing higher after an analyst initiated coverage with a bullish outlook.
As of 11:02 a.m ET, shares of Vertex are up 4.4%, retreating from an earlier gain of 7.5%.
Image source: Getty Images.
This firm sees strong revenue growth ahead Initiating coverage today with a buy rating, TD Cowen assigned a $14 price target to Vertex, a software specialist that helps businesses maintain compliance with tax laws. TD Cowen based its bullish outlook on the belief that the company can maintain double-digit revenue growth through fiscal 2028 and possible beyond.
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Based on Vertex's stock closing at $11.37 on Friday, TD Cowen's $14 price target implies upside of 23.1%.
TD Cowen's price target is consistent with other firms. In early May, for example, Jefferies and Morgan Stanley assigned price targets of $14 and $19, respectively.
Is Vertex stock a buy after today's news? Underperforming the market, Vertex stock has suffered in 2026, falling more than 41% year to date as of this writing. While the company achieved growth across several metrics in the first quarter of 2026, investors remain skeptical. Vertex reported net revenue retention of 105% in Q1 2026, down from 109% during the same period last year.
Although the company's decline in net revenue retention is undesirable, it reported strong sales and free cash flow growth in Q1 2026. With shares of the tech stock trading at 11.8 times operating cash flow -- a discount to its five-year average cash flow multiple of 31.8 -- now looks like a good time to consider a position while the stock is sitting in the bargain bin.
Scott Levine has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Jefferies Financial Group. The Motley Fool has a disclosure policy.
SummaryVertex Pharmaceuticals Incorporated's R&D success extends beyond its cystic fibrosis franchise.VRTX's Povetacicept could be approved by the FDA as early as November 30th for the treatment of an autoimmune disease called immunoglobulin A nephropathy.On the other hand, despite the high commercial expectations for Journavx and Casgevy, demand remains soft.This "duo" generated only $71.9 million in revenue for VRTX in Q1, a 11.2% decline year-on-year.That's why I believe VRTX stock's risk/reward is balanced. unomat/iStock via Getty Images
Since my February article, "Vertex Pharmaceuticals Stock: Is The Bull Run Over," Vertex Pharmaceuticals Incorporated (VRTX) shares have declined by as much as 12%, hitting a low of $412.9 on May 5, before rallying
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Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.
HOUSTON--(BUSINESS WIRE)--Vertex Energy, Inc. (“Vertex” or the “Company”) today announced it is advancing a project at its Mobile, Alabama refinery to produce crude-derived conventional Group III base oils through the Company’s existing hydrocracker and related processing infrastructure, providing lubricant manufacturers and blenders with an additional domestic source of high-quality Group III supply.
We believe the planned investments, combined with our existing hydrocracker, give Vertex a compelling pathway to supply the conventional Group III market and support customers seeking reliable domestic supply.
Share The project is designed to add an incremental 6,000 barrels per day of conventional Group III production capacity and support production of 4 cSt, 6 cSt, and 8 cSt Group III base oils using an existing crude-derived hydrocracked vacuum gas oil stream produced at the Company’s Mobile, Alabama refinery. Combined with the Company’s existing re-refined Group III base oil production, this additional capacity is expected to make Vertex the leading Group III producer in North America. Vertex has completed preliminary design work and has procured a high-pressure lubricants hydrotreating unit. The Company plans to start production of conventional Group III base oils in 2029.
“This project reflects a major milestone in our continued focus on improved profitability and margin stabilization,” said Mark Smith, Chief Executive Officer of Vertex Energy. “We believe the planned investments, combined with our existing hydrocracker, give Vertex a compelling pathway to supply the conventional Group III market and support customers seeking reliable domestic supply.”
Group III base oils are used in a range of high-performance lubricant applications, including automotive and industrial lubricants that require strong performance characteristics and consistent product quality. The project will complement Vertex’s existing fuels and re-refined base oil operations, with the Company continuing to produce transportation fuels and 4 cSt and 6 cSt re-refined Group III base oils as part of its integrated platform while adding conventional Group III production capability.
For more information on Vertex, visit the Company’s website at vertexenergy.com.
ABOUT VERTEX ENERGY
Vertex is a leading specialty refiner of base oils and conventional fuels. The Company operates an integrated used motor oil (“UMO”) collection and processing network across the southern United States, securing a reliable feedstock supply for its base oil re-refining operations. Vertex provides U.S.-produced refined products with global reach, delivering solutions that enhance performance and value for its customers.
Key Takeaways Vertex is advancing kidney disease candidates to diversify beyond its cystic fibrosis business.VRTX completed a rolling U.S. filing for povetacicept in IgAN after positive phase III data.Vertex expects its kidney portfolio to generate several billion dollars annually over the next decade. Vertex Pharmaceuticals Incorporated (VRTX - Free Report) is a clear leader in the global cystic fibrosis (CF) market. The company has built a dominant position through scientific innovation, first-mover advantages, and a portfolio of highly effective CFTR modulator therapies that have transformed the treatment paradigm for most CF patients.
Although Vertex’s cystic fibrosis (CF) franchise remains highly resilient, sustaining long-term growth will require diversification beyond its core business. To achieve this, the company is rapidly advancing a portfolio of mid- to late-stage pipeline candidates across several disease areas outside of CF.
Among its non-CF pipeline candidates, Vertex’s kidney disease programs are drawing significant investor interest. The company is building one of the most differentiated kidney disease franchises in biotech by targeting the underlying biological mechanisms of multiple kidney disorders, rather than merely treating symptoms or slowing disease progression.
The company's renal portfolio currently consists of key pipeline candidates like VX-407 for autosomal dominant polycystic kidney disease (ADPKD), inaxaplin for APOL1-mediated kidney disease (AMKD) and povetacicept for IgA nephropathy (IgAN) and primary membranous nephropathy (pMN). It is believed that povetacicept and inaxaplin represent significant commercial opportunities.
Povetacicept was added to Vertex’s portfolio from the Alpine acquisition in 2024. Vertex believes povetacicept has pipeline-in-a-product potential for B-cell-mediated diseases. Povetacicept is designed to target two proteins, namely BAFF and APRIL, which are jointly responsible for causing multiple serious autoimmune diseases. Based on positive interim data from the RAINIER phase III study in IgAN, a rolling BLA filing for povetacicept for IgAN was completed in March 2026 for potential accelerated approval in the United States.
Data from the RAINIER study showed that povetacicept led to a rapid, deep and sustained improvement in proteinuria (excess protein in the urine), a direct consequence of IgAN. Vertex is also conducting a pivotal phase II/III study of povetacicept for a second potential renal indication, pMN. Vertex has also initiated a phase II study on povetacicept for the treatment of gMG in the first half of 2026.
With potential approvals in IgAN and pMN, povetacicept could emerge as a major growth driver for Vertex, with analysts forecasting blockbuster sales and peak annual revenues in the multi-billion-dollar range.
Vertex expects its kidney disease portfolio to become a significant long-term growth driver, generating several billion dollars in annual revenues over the next decade while diversifying the company’s revenue base.
VRTX’s Price, Valuation and EstimatesVertex stock has risen 0.7% over the past year, underperforming the industry’s 24.2% growth.
Image Source: Zacks Investment Research
From a valuation standpoint, Vertex is slightly expensive. Going by the price/earnings ratio, the company’s shares currently trade at 22.47 forward earnings, higher than 17.38 for the industry. The stock is, however, trading below its five-year mean of 24.86.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 earnings has risen from $19.01 per share to $19.15 per share over the past 60 days, while that for 2027 has deteriorated from $21.38 per share to $21.19 per share over the same time frame.
Image Source: Zacks Investment Research
VRTX’s Zacks RankVertex has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings estimates for Indivior Pharmaceuticals have risen from $3.33 per share to $4.05 per share, while those for 2027 have increased from $3.66 per share to $4.27 per share. INDV shares have risen 6.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, earnings per share estimates for Liquidia have risen from $1.50 to $2.97, while those for 2027 have increased from $2.91 to $4.81. LQDA shares have gained 106.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore for 2026 have improved from a loss of 88 cents per share to earnings of 6 cents per share, while those for 2027 have increased from 24 cents per share to 87 cents per share over the same timeframe. IMCR shares have lost 17.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
Vertex Pharmaceuticals (VRTX 1.60%) and Eli Lilly (LLY 1.16%) are two leading drugmakers that dominate their respective core therapeutic areas. Vertex has a monopoly in the market for drugs that treat cystic fibrosis (CF), a rare disease that affects patients' lungs. Eli Lilly leads the market for anti-obesity medicines and has a strong presence in diabetes care. Despite their strong performances in these fields, both are actively trying to decrease their exposure to their most important markets. What's more, Vertex and Eli Lilly have chosen a diversification path that puts them on an eventual collision course. Here's what investors should know.
Image source: The Motley Fool.
Revolutionizing the market for pain management There are plenty of medicines to help patients who suffer from acute or chronic pain. However, many options carry significant potential side effects. For instance, opioid-based pain medications can cause gastrointestinal side effects, but those are mild compared to the possibility that patients will develop dependence -- or perhaps even addiction -- to them. That's why there is a need for new, non-opioid options. Vertex Pharmaceuticals has made significant strides in that direction. Last year, it received approval for Journavx to treat moderate-to-severe acute pain. It became the first oral non-opioid pain signal inhibitor to receive the green light from the U.S. Food and Drug Administration.
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Journavx hasn't generated much revenue yet, but we could see the medicine's sales ramp up over the next few years. It could also earn a label expansion in diabetic peripheral neuropathy (DPN). Further, Vertex Pharmaceuticals is developing another pain medicine, VX-993, that is undergoing phase 2 studies in DPN. These products could go a long way in helping Vertex decrease its exposure to its CF portfolio. Meanwhile, Eli Lilly has made several acquisitions to dip its toes in this space.
Last year, Lilly acquired SiteOne Therapeutics in a deal valued at up to $1 billion in upfront and milestone payments. The key asset from that transaction was STC-004, an investigational non-opioid treatment for chronic pain. And more recently, Eli Lilly announced it would acquire 4E Therapeutics for an undisclosed amount. 4E Therapeutics' platform focuses on developing non-opioid treatments for chronic pain. Its lead asset, 4ET1103, showed a robust safety profile in a phase 1 study.
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Can Eli Lilly catch up to Vertex Pharmaceuticals? Vertex has a lead in this market, and it will likely be at least a couple of years (or so) before Eli Lilly launches a competitor. However, a first-move advantage -- while important -- isn't everything. Provided Eli Lilly's candidates post stronger efficacy results than Vertex's, the former could still dominate this space. That's what Eli Lilly did in the weight management space. Despite Zepbound earning approval more than two years after its main competitor, Wegovy, Zepbound now has the lead.
Still, it's too early to tell whether Eli Lilly will pull off the same feat in this niche. It's also worth pointing out that there could be plenty of room for multiple winners. Vertex Pharmaceuticals estimates that there are 80 million patients in North America and Europe who suffer from acute pain, with several million more in smaller niches such as DPN. So, both Vertex Pharmaceuticals and Eli Lilly could capitalize on this opportunity.
Which stock is a buy? Vertex Pharmaceuticals has lagged broader equities over the past 12 months, but the company continues to post solid financial results thanks to its dominance in the CF market. Also, the biotech leader is slowly generating more revenue from newer, non-CF launches, including Journavx and a gene editing medicine for a pair of blood-related disorders called Casgevy. Vertex Pharmaceuticals expects at least $500 million in revenue from this duo this year. Lastly, the company should expand its lineup even more soon. It is inching closer to earning approval for povetacicept, a medicine for IgA Nephropathy (a kidney disease), and it boasts several other pipeline candidates.
These factors suggest that Vertex Pharmaceuticals could perform well over the medium term, making it an attractive stock to buy now. We could say the same about Eli Lilly. The pharmaceutical giant has a deep pipeline in its core area, which will help it capitalize on the fast-growing weight-loss market. It also has blockbusters and attractive pipeline candidates in other fields. Eli Lilly is generating strong revenue and earnings and boasts a solid dividend program, making the stock an excellent pick for investors.
Vertex Pharmaceuticals remains the leader in cystic fibrosis but is now executing a tangible diversification into pain, renal, and gene therapies. VRTX's CF franchise continues to grow via ALYFTREK's launch, geographic expansion, and penetration into younger and rare mutation populations, supporting robust revenue. New products JOURNAVX and CASGEVY are gaining traction, and the renal pipeline—especially povetacicept—could become a second franchise with multi-billion-dollar potential.
On April 24, 2026, Vertex Inc VERX shares rose 7.2% today, currently trading at $12.52. The stock has fluctuated within a 52-week range of $10.59 to $42.44, reflecting significant volatility over the past year.
GF Value™ verdict: The current price of $12.52 represents a 65.0% discount to the GF Value™ estimate of $35.82.GF Score™: The stock holds a score of 65/100, indicating an above-average rating.Most notable signal: Insiders have shown confidence by purchasing $6.4M in stock over the last three months, with no selling activity reported. Is VERX Overvalued or Undervalued? The current share price of Vertex Inc VERX at $12.52 is significantly below the GF Value™ estimate of $35.82, suggesting that the stock could be undervalued by approximately 65.0%. This difference indicates a substantial margin of safety for potential investors, as the market price does not reflect the intrinsic value suggested by the GF Value™. However, it is essential to consider that the GF Valuation label indicates a "Possible Value Trap," which means that while the stock appears undervalued based on the GF Value™, there may be underlying issues that could hinder its recovery or growth.
GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates. Investors are encouraged to perform thorough due diligence, as the current undervaluation must be assessed against the company's financial health and market conditions.
How Does VERX's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 313.0x 299.9x Forward P/E 17.3x N/A Vertex Inc's current P/E (TTM) ratio stands at 313.0x, which is slightly above its 5-year median of 299.9x. In contrast, the forward P/E ratio of 17.3x suggests a more favorable valuation going forward. This P/E analysis aligns with the GF Value™ verdict, indicating that while the stock is currently trading above its historical valuation metrics, the potential for future earnings growth may warrant consideration. However, the high current P/E could also signal that the market is pricing in significant future growth, which may not materialize.
What Does VERX's GF Score™ Tell Us? Metric Rating GF Score™ 65 Financial Strength 4/10 Profitability 4/10 Growth 8/10 Valuation 2/10 Momentum 2/10 The GF Score™ of 65/100 reflects an above-average rating for Vertex Inc, highlighted primarily by its strong growth rank of 8/10. However, the valuation and momentum ranks are notably weak at 2/10, suggesting potential concerns about the stock's current price performance and overall valuation metrics. The financial strength and profitability ranks are also average, indicating that while the company exhibits growth potential, it may face challenges in maintaining financial stability and profitability in the near term.
What Are Insiders Doing with VERX Stock? Recent insider activity for Vertex Inc shows a strong buying trend, with insiders purchasing $6.4 million worth of shares in the last three months and no reported selling. This pattern of insider buying can be a positive signal, indicating that those with the most knowledge of the company's operations and prospects believe that the stock is undervalued and has significant upside potential. Such confidence from insiders often suggests that they foresee improvements in the company's performance or market conditions.
What This Means for Investors Based on the analysis, Vertex Inc VERX appears to be undervalued according to GF Value™, with a substantial margin of safety. However, potential investors should exercise caution due to the "Possible Value Trap" label, which implies that while the stock seems attractive at its current price, underlying financial metrics may present risks that need further investigation.
For the complete analysis, visit the Vertex Inc VERX stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities.
Frequently Asked Questions What is VERX's GF Score™?
VERX's GF Score™ is 65/100, indicating an above-average rating based on key aspects affecting long-term returns.
Is VERX overvalued or undervalued?
VERX is currently considered undervalued, with a GF Value™ estimate suggesting a significant upside potential compared to its current price.
What is VERX's P/E ratio?
VERX's P/E (TTM) is 313.0x, which is slightly above its 5-year median of 299.9x, indicating that the stock is trading at higher valuation multiples compared to its historical averages.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].
Key Takeaways VRTX is set to report Q1 results on May 4, with consensus estimates of $2.98B revenue and $4.20 EPS.Trikafta/Kaftrio demand likely led CF growth, while Alyftrek launch progressed in the U.S. and Europe.Casgevy and Journavx sales are expected to rise as access, reimbursement and prescriptions improve. Vertex Pharmaceuticals (VRTX - Free Report) is scheduled to report its first-quarter 2026 results on May 4, after market close. The Zacks Consensus Estimate for the to-be-reported quarter’s revenues is pegged at $2.98 billion, while the same for earnings is $4.20 per share.
Let’s see how things might have shaped up before the announcement.
Factors Likely to Influence VRTX's Q1 ResultsVertex’s revenues in the to-be-reported quarter are likely to have been driven by strong demand for blockbuster cystic fibrosis (“CF”) medicine, Trikafta/Kaftrio (Trikafta’s brand name in Europe), in the United States. The Zacks Consensus Estimate for Trikafta/Kaftrio sales is currently pegged at $2.40 billion.
However, higher Trikafta/Kaftrio sales are likely to have caused sales erosion of VRTX’s other CF drugs — Symdeko (marketed as Symkevi in Europe), Orkambi and Kalydeco.
Though Vertex’s CF franchise sales continue to grow, driven by demand growth of Trikafta/Kaftrio in younger age groups, we expect investors to focus on the sales performance of its fifth CF medicine, Alyftrek (vanza triple), during the first quarter.
Alyftrek sales increased sequentially in the last reported quarter, a trend most likely to have continued in the to-be-reported quarter. Per management, the U.S. launch of Alyftrek is progressing well across all patient groups, while in ex-U.S. markets, the early launch of Alyftrek is off to a strong start in multiple European countries, where patients have reimbursed access.
Year to date, shares of Vertex have plunged 6.1% compared with the industry’s decline of 1.2%.
Image Source: Zacks Investment Research
VRTX’s Other New Products Sales Expectation for Q1Vertex and its partner CRISPR Therapeutics’ (CRSP - Free Report) one-shot gene therapy, Casgevy, was approved in late 2023/early 2024 for two blood disorders — sickle cell disease and transfusion-dependent beta-thalassemia.
Vertex leads the global development and commercialization of Casgevy under the terms of the 2021 agreement, with support from CRISPR Therapeutics.
Casgevy sales increased significantly on a sequential basis in the last quarter due to robust patient growth. Vertex is also making rapid progress in the drug’s access and reimbursement.
In 2026, Vertex expects significant growth in Casgevy’s sales as the therapy’s launch metrics look positive, with growing cell collections and product infusions. Investors will be keen to get more updates on the same on the upcoming earnings call.
VRTX’s novel non-opioid pain medicine Journavx (suzetrigine) was approved by the FDA in January 2025. Journavx’s sales improved sequentially in the last quarter, driven by strong prescription growth. Also, the drug’s launch metrics and early reimbursement progress look favorable. Vertex expects higher sales from Journavx in the first quarter as prescription volumes are rising.
Several updates related to Vertex’s pipeline candidates, which are in mid- to late-stage studies for treating diseases like acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, and cell therapy for type I diabetes, are also expected on the upcoming earnings call.
VRTX's Earnings Surprise HistoryVertex has a mixed history of earnings surprises over the trailing four quarters. The company beat earnings estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, delivering an average surprise of 1.88%. In the last reported quarter, VRTX posted a negative earnings surprise of 0.79%.
Earnings Whispers for VRTX StockOur proven model does not conclusively predict an earnings beat for Vertex this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat, which is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
VRTX’s Earnings ESP: Vertex’s Earnings ESP is -0.54% as the Most Accurate Estimate currently stands at $4.18, lower than the Zacks Consensus Estimate of $4.20.
VRTX’s Zacks Rank: Vertex currently carries a Zacks Rank #3. You can see the complete list of today’s Zacks #1 Rank stocks here.
Stocks to ConsiderHere are some stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle.
Agenus (AGEN - Free Report) has an Earnings ESP of +7.69% and a Zacks Rank #1 at present.
Shares of AGEN have risen 30.2% year to date. The company’s earnings beat estimates in two of the trailing four quarters, while missing the mark on the other two occasions. Agenus delivered an average earnings surprise of 31.42%.
Inovio Pharmaceuticals (INO - Free Report) has an Earnings ESP of +3.33% and a Zacks Rank #2 at present.
Shares of INO have lost 32.8% year to date. The company’s earnings beat estimates in each of the trailing four quarters. INO delivered an average earnings surprise of 57.94%.
– Total revenue of $2.99 billion, an 8% increase compared to first quarter 2025 –
– Povetacicept program continues rapid advancement: Completed rolling BLA submission for U.S. accelerated approval for povetacicept in IgA nephropathy, following positive Phase 3 interim analysis data; initiated Phase 3 portion of Phase 2/3 study in primary membranous nephropathy and Phase 2 proof-of-concept study in generalized myasthenia gravis –
– Continued progress across broad clinical-stage pipeline, including label expansion of eligible U.S. patient populations for ALYFTREK and TRIKAFTA and completion of U.S. regulatory submission for approval of CASGEVY in children ages 5 to less than 12 years old with SCD or TDT–
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the first quarter ended March 31, 2026, and reiterated its full year 2026 financial guidance.
“Vertex is off to a strong start in 2026, driven by leadership in cystic fibrosis; growth in sickle cell disease, beta thalassemia, and acute pain; as well as rapid pipeline progress,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “CASGEVY and JOURNAVX delivered more than 25 percent of our growth this quarter, underscoring the strength of the increasingly diversified revenue base. As we execute across the commercial portfolio and pipeline and build our fourth franchise in nephrology, Vertex is poised to continue to deliver for patients and create long-term value.”
First Quarter 2026 Results
Total revenue increased 8% to $2.99 billion compared to the first quarter of 2025, primarily driven by the continued performance of cystic fibrosis (CF) therapies and growth from diversification into additional disease areas. In the U.S., total revenue increased 7% to $1.78 billion due to continued strong CF patient demand, including from new initiations of ALYFTREK; higher realized net prices in CF versus the prior year; and contributions from CASGEVY and JOURNAVX. Outside the U.S., total revenue increased 9% to $1.21 billion due to strong CF performance across multiple geographies, including ALYFTREK uptake, increased CASGEVY revenue, and a favorable impact from foreign exchange.
Combined GAAP and non-GAAP R&D, Acquired IPR&D and SG&A expenses were $1.5 billion and $1.3 billion, respectively, in the first quarter of 2026, compared to $1.4 billion and $1.2 billion, respectively, for the first quarter of 2025. These increases were primarily due to commercial investment to support the launch of JOURNAVX in acute pain and the build-out of the renal franchise, led by povetacicept in IgAN.
GAAP effective tax rate was 17.7% compared to 11.5% for the first quarter of 2025, primarily due to higher excess tax benefits related to stock-based compensation and lower pre-tax book income in the first quarter of 2025 due to an intangible asset impairment charge.
Non-GAAP effective tax rate was 19.6% compared to 18.8% for the first quarter of 2025.
GAAP net income was $1.0 billion compared to $646 million for the first quarter of 2025, as a result of increased product revenue, partially offset by increased operating expenses and income tax expenses. In addition, first quarter 2025 results included a $379.0 million intangible asset impairment charge.
Non-GAAP net income was $1.1 billion, an increase of $93 million compared to the first quarter of 2025, primarily due to increased product revenue, partially offset by increased operating and income tax expenses in the first quarter of 2026.
Cash, cash equivalents, and total marketable securities as of March 31, 2026, were $13.0 billion, compared to $12.3 billion as of December 31, 2025. The increase was primarily due to cash flows from operating activities, partially offset by repurchases of Vertex’s common stock pursuant to its share repurchase programs.
Full Year 2026 Financial Guidance
Vertex today reiterated full year 2026 financial guidance. Vertex’s total revenue guidance of $12.95 billion to $13.1 billion includes expectations for continued growth in CF, including the ongoing U.S. rollout and ex-U.S. launches of ALYFTREK, as well as $500 million or more in revenue from non-CF products, including increased patient infusions of CASGEVY through Vertex’s global ATC network and growth in prescriptions and revenue from the second year of the launch of JOURNAVX. Vertex’s guidance for both combined GAAP and non-GAAP R&D, AIPR&D, and SG&A expenses includes expectations for continued investment in multiple mid- and late-stage clinical development programs and commercialization capabilities, and approximately $100 million of currently anticipated AIPR&D expenses. This guidance also includes an immaterial cost impact from tariffs in 2026 based on currently known tariff rates and regulations.
Vertex’s financial guidance is summarized below:
Current FY 2026
Previous FY 2026
Total revenue
Unchanged
$12.95 to $13.1 billion
Non-CF product revenue
Unchanged
$0.5 billion or greater
Combined GAAP R&D, AIPR&D and SG&A expenses *
Unchanged
$6.3 to $6.45 billion
Combined non-GAAP R&D, AIPR&D and SG&A expenses*
Unchanged
$5.65 to $5.75 billion
Non-GAAP effective tax rate
Unchanged
19.5% to 20.5%
*The difference between the combined GAAP R&D, AIPR&D and SG&A expenses and the combined non-GAAP R&D, AIPR&D and SG&A expenses guidance relates primarily to $650 million to $700 million of stock-based compensation expense.
**Combined GAAP and non-GAAP R&D, AIPR&D and SG&A expenses guidance includes approximately $100 million of AIPR&D expenses.
Key Business Highlights
Marketed Products
Cystic Fibrosis (CF) Portfolio
Vertex has worked for more than 20 years to discover and develop medicines to treat the underlying cause of CF. Vertex CFTR modulators can treat approximately 95 percent of all people living with CF in core markets, including patients as young as one month old. ALYFTREK, the newest marketed CFTR modulator, is approved in the U.S., the United Kingdom (U.K.), the European Union (EU), Canada, New Zealand, Switzerland, Australia, and Israel for the treatment of patients 6 years and older. Vertex anticipates that the number of CF patients taking its medicines will continue to grow through new approvals and reimbursement agreements, treatment of younger patients, increased survival, and expansion into additional geographies. Recent progress includes:
The U.S. Food and Drug Administration (FDA) recently approved label extensions for ALYFTREK and TRIKAFTA, expanding availability of these medicines to approximately 95% of all people with CF in the United States. This label expansion was supported by clinical and/or in vitro data from 564 variants demonstrating response to ALYFTREK and 521 variants demonstrating response to TRIKAFTA. With this approval, approximately 800 more people with CF in the U.S. are now eligible for the first time for a medicine that treats the underlying cause of their disease. Vertex recently secured reimbursement agreements for ALYFTREK in Scotland, Spain, Sweden, Switzerland, New Zealand, Israel, and Finland and is working to secure access for eligible patients in additional countries. Following recently reported positive results from the study of ALYFTREK in children ages two to five years, Vertex is on track to submit for global regulatory approvals in the first half of 2026. Vertex continues to enroll and dose the pivotal study of ALYFTREK in children ages one to less than two years. Following recently reported positive results from the study of TRIKAFTA in children ages one to less than two years, Vertex has begun submissions for global regulatory approvals for TRIKAFTA in this age group. CASGEVY for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)
CASGEVY is a non-viral, ex vivo, CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT that has been shown to reduce or eliminate vaso-occlusive crises (VOCs) for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved in the U.S., the U.K., the EU, the Kingdom of Saudi Arabia (KSA), the Kingdom of Bahrain, Qatar, Canada, Switzerland, the United Arab Emirates (UAE), and Kuwait for patients 12 years and older with SCD or TDT. In total, there are more than 60,000 eligible patients in these countries, including approximately 37,000 in North America and Europe and more than 23,000 in the Middle East. Recent highlights include:
Vertex recorded first quarter 2026 CASGEVY revenue of $43 million. Vertex recently secured a pricing agreement for CASGEVY for eligible patients with SCD or TDT in Germany. Vertex is now working through final implementation to provide long-term reimbursed access to patients at a sustainable price. Vertex completed the regulatory submission in the U.S. for approval of CASGEVY in children ages 5 to less than 12 years old with SCD or TDT. The FDA awarded Vertex a Commissioner’s National Priority Voucher for this pediatric submission, indicating an accelerated timeline for review once the submission is accepted. JOURNAVX (suzetrigine) for the treatment of moderate-to-severe acute pain
JOURNAVX is a first-in-class, oral, selective, non-opioid NaV1.8 pain signal inhibitor, approved in the U.S. for the treatment of moderate-to-severe acute pain.
Since the launch of JOURNAVX in March 2025, more than 1 million prescriptions have now been filled for JOURNAVX across the hospital and retail settings for a broad range of acute pain conditions. In the first quarter of 2026, more than 350,000 prescriptions were filled, and Vertex recorded revenue of $29 million. The Centers for Medicare and Medicaid Services (CMS) have approved the inclusion of JOURNAVX in the NOPAIN Act separate payment list, with a retroactive payment date of January 23, 2026. Addition to the NOPAIN list provides a separate payment for non-opioid medicines such as JOURNAVX in the hospital outpatient and ambulatory surgical center settings. Vertex has reached an agreement with a major pharmacy benefit manager for Medicare Part D coverage for JOURNAVX, effective May 1. The agreement adds approximately 10 million lives covered under Part D. Twenty-two states now provide coverage for JOURNAVX via Medicaid. In total, approximately 240 million individuals now have reimbursed access to JOURNAVX across a wide range of commercial and government payers. Select R&D Pipeline Programs
Cystic Fibrosis
Consistent with its commitment to serial innovation and bringing as many patients as possible to normal levels of CFTR function, Vertex is evaluating VX-828, the first of the next-generation 3.0 CFTR corrector class, in a proof-of-concept study in people with CF. Vertex is on track to complete dosing in this study in the first half of 2026 and share results in the second half. Vertex is enrolling and dosing first-in-human studies with VX-581 and VX-272, additional next-generation 3.0 CFTR correctors. Vertex has ended the Phase 1/2 study of VX-522 after observing persistent tolerability issues in the study. The early termination precludes assessment of efficacy and full safety and prevents further development of the VX-522 program. Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
Vertex continues to advance preclinical assets for gentler conditioning for CASGEVY, which could broaden the eligible patient population. Acute and Peripheral Neuropathic Pain (PNP)
Vertex is on track to complete enrollment in both Phase 3 studies of suzetrigine in diabetic peripheral neuropathy (DPN), a form of peripheral neuropathic pain (PNP), by the end of 2026. Vertex also continues to enroll and dose people with DPN in a Phase 2 study of VX-993. Vertex continues to advance preclinical assets that inhibit NaV1.7 for use alone or in combination with a NaV1.8 inhibitor in acute and neuropathic pain. IgA Nephropathy (IgAN) and Other B Cell-Mediated Diseases
Vertex is developing povetacicept for multiple diseases. Povetacicept is a dual inhibitor of the BAFF and APRIL cytokines, which play key roles in the pathogenesis of multiple B cell-mediated autoimmune diseases. Povetacicept has pipeline-in-a-product potential and represents a potentially best-in-class approach to control B cell activity in IgAN, primary membranous nephropathy (pMN), and generalized myasthenia gravis (gMG).
In March, Vertex reported positive Week 36 interim analysis results for the primary and all secondary endpoints in the RAINIER Phase 3 trial of povetacicept in adults with IgAN. Based on these results, Vertex completed the submission of its rolling biologics license application (BLA) to the FDA in March for potential accelerated approval in the U.S. Vertex is using a Priority Review Voucher and therefore expects the FDA review of povetacicept’s BLA to be expedited to six months from the date of the FDA’s acceptance of the BLA. Vertex recently completed enrollment in the Phase 2 portion of the Phase 2/3 OLYMPUS pivotal study of povetacicept in people with pMN and initiated the Phase 3 portion. Enrollment and dosing in the trial are ongoing. The FDA has granted Fast Track and Orphan Drug designations for povetacicept in pMN, and the EMA has granted Priority Medicines (PRIME) designation. Vertex has initiated a placebo-controlled, Phase 2 dose-ranging proof-of-concept study evaluating povetacicept for the treatment of gMG. APOL1-Mediated Kidney Disease (AMKD)
Vertex has discovered and advanced multiple oral, small molecule inhibitors of APOL1 function, pioneering a new class of medicines that targets the underlying cause of this genetic kidney disease.
In the second half of 2025, Vertex completed enrollment in the interim analysis cohort of the AMPLITUDE Phase 2/3 trial of inaxaplin in people with primary AMKD and will conduct the pre-planned interim analysis for potential accelerated approval after this cohort reaches 48 weeks of treatment. Vertex expects to share data from the interim analysis in early 2027. The AMPLITUDE study is on track to complete full enrollment in the second half of 2026. Vertex has completed enrollment in the AMPLIFIED Phase 2 study of inaxaplin. AMPLIFIED is a study of people with AMKD with moderate proteinuria, and people with AMKD and Type 2 diabetes — populations not being studied in the AMPLITUDE trial. Vertex is on track to complete dosing and share data from the AMPLIFIED study in the second half of 2026. Type 1 Diabetes (T1D)
Vertex is evaluating stem cell-derived, fully differentiated islet cell therapies for patients suffering from T1D, with the goal of developing a potential one-time functional cure for this disease.
Vertex has completed the internal manufacturing analysis for the Phase 1/2/3 study of zimislecel in people with T1D and has resumed dosing in the study. Multiple patients have been treated since the resumption of dosing. The company expects to provide updated timelines for study completion later this year. Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Vertex is developing small molecule correctors that restore function to polycystin 1 (PC1) protein variants, with the goal of addressing the underlying cause of ADPKD.
Vertex is enrolling and dosing AGLOW, a Phase 2 study of VX-407 in patients with a subset of variants in the PKD1 gene, which encodes the PC1 protein, estimated to be up to approximately 30,000 (or up to approximately 10%) of the overall patient population living with ADPKD. AGLOW is a 24-patient, single-arm, 52-week, Phase 2 proof-of-concept study that will evaluate the effect of VX-407 on height-adjusted total kidney volume (htTKV). AGLOW is on track to complete enrollment in the second half of 2026. Myotonic Dystrophy Type 1 (DM1)
Vertex is evaluating multiple approaches that target the underlying cause of DM1. Vertex’s lead approach, VX-670, is an oligonucleotide linked to a cyclic peptide, which holds the potential to promote effective delivery into cells and address the causal biology of DM1.
Vertex continues to enroll and dose the MAD portion of the GALILEO global Phase 1/2 clinical trial of VX-670 in people with DM1; the study is assessing both safety and efficacy. Vertex is on track to complete enrollment and dosing in the trial and share results in the second half of 2026. Additional Earlier Stage R&D Programs
Consistent with its overall strategy, Vertex takes a serial innovation approach to all of its programs, with additional assets or approaches across its portfolio.
Non-GAAP Financial Measures
In this press release, Vertex's financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial results and guidance exclude from Vertex's pre-tax income (i) stock-based compensation expense, (ii) intangible asset amortization expense, (iii) gains or losses related to the fair value of the company's strategic investments, (iv) increases or decreases in the fair value of contingent consideration, (v) an intangible asset impairment charge, and (vi) other adjustments. The company's non-GAAP financial results also exclude from its provision for income taxes the estimated tax impact related to its non-GAAP adjustments to pre-tax income described above and certain discrete items. These results should not be viewed as a substitute for the company’s GAAP results and are provided as a complement to results provided in accordance with GAAP. Management believes these non-GAAP financial measures help indicate underlying trends in the company's business, are important in comparing current results with prior period results and provide additional information regarding the company's financial position that the company believes is helpful to an understanding of its ongoing business. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, to manage the company's business and to evaluate its performance. The company’s calculation of non-GAAP financial measures likely differs from the calculations used by other companies. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.
The company provides guidance regarding combined R&D, AIPR&D and SG&A expenses and effective tax rate on a non-GAAP basis. Unless otherwise noted, the guidance regarding combined R&D, AIPR&D and SG&A expenses does not include estimates associated with any potential future business development transactions, including collaborations, asset acquisitions and/or licensing of third-party intellectual property rights. The company does not provide guidance regarding its GAAP effective tax rate because it is unable to forecast with reasonable certainty the impact of excess tax benefits related to stock-based compensation and the possibility of certain discrete items, which could be material.
Vertex Pharmaceuticals Incorporated
Consolidated Statements of Income
(unaudited, in millions, except per share amounts)
Three Months Ended March 31,
2026
2025
Revenues:
Product revenues, net
$
2,986.9
$
2,760.2
Other revenues
—
10.0
Total revenues
2,986.9
2,770.2
Costs and expenses:
Cost of sales
392.8
363.0
Research and development expenses
961.6
979.7
Acquired in-process research and development expenses
0.5
19.8
Selling, general and administrative expenses
493.7
396.4
Intangible asset impairment charge
—
379.0
Change in fair value of contingent consideration
0.2
2.2
Total costs and expenses
1,848.8
2,140.1
Income from operations
1,138.1
630.1
Interest income, net
114.8
117.9
Other expense, net
—
(17.6
)
Income before provision for income taxes
1,252.9
730.4
Provision for income taxes
221.5
84.1
Net income
$
1,031.4
$
646.3
Net income per common share:
Basic
$
4.06
$
2.52
Diluted
$
4.02
$
2.49
Shares used in per share calculations:
Basic
254.1
256.9
Diluted
256.3
259.5
Vertex Pharmaceuticals Incorporated
Total Revenues
(unaudited, in millions)
Three Months Ended March 31,
2026
2025
TRIKAFTA/KAFTRIO
$
2,354.7
$
2,535.5
ALYFTREK
424.4
53.9
Other CF product revenues (1)
135.9
155.3
Total CF product revenues, net
2,915.0
2,744.7
CASGEVY
42.9
14.2
JOURNAVX
29.0
1.3
Product revenues, net
2,986.9
2,760.2
Other revenues
—
10.0
Total revenues
$
2,986.9
$
2,770.2
1: Includes KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI
Vertex Pharmaceuticals Incorporated
Reconciliation of GAAP to Non-GAAP Financial Information
(unaudited, in millions, except percentages)
Three Months Ended March 31,
2026
2025
GAAP cost of sales
$
392.8
$
363.0
Stock-based compensation expense
(3.2
)
(2.6
)
Intangible asset amortization expense
(5.0
)
(5.0
)
Non-GAAP cost of sales
$
384.6
$
355.4
GAAP research and development expenses
$
961.6
$
979.7
Stock-based compensation expense
(101.7
)
(100.1
)
Intangible asset amortization expense
(0.6
)
(0.6
)
Non-GAAP research and development expenses
$
859.3
$
879.0
Acquired in-process research and development expenses
$
0.5
$
19.8
GAAP selling, general and administrative expenses
$
493.7
$
396.4
Stock-based compensation expense
(61.5
)
(63.4
)
Non-GAAP selling, general and administrative expenses
$
432.2
$
333.0
Combined non-GAAP R&D, AIPR&D and SG&A expenses
$
1,292.0
$
1,231.8
GAAP other expense, net
$
—
$
(17.6
)
Decrease in fair value of strategic investments
2.0
15.0
Non-GAAP other income (expense), net
$
2.0
$
(2.6
)
GAAP provision for income taxes
$
221.5
$
84.1
Tax adjustments (2)
58.6
160.1
Non-GAAP provision for income taxes
$
280.1
$
244.2
GAAP effective tax rate
17.7
%
11.5
%
Non-GAAP effective tax rate
19.6
%
18.8
%
Vertex Pharmaceuticals Incorporated
Reconciliation of GAAP to Non-GAAP Financial Information (continued)
(unaudited, in millions, except per share amounts)
Three Months Ended March 31,
2026
2025
GAAP operating income
$
1,138.1
$
630.1
Stock-based compensation expense
166.4
166.1
Intangible asset impairment charge
—
379.0
Intangible asset amortization expense
5.6
5.6
Increase in fair value of contingent consideration
0.2
2.2
Non-GAAP operating income
$
1,310.3
$
1,183.0
GAAP net income
$
1,031.4
$
646.3
Stock-based compensation expense
166.4
166.1
Intangible asset impairment charge
—
379.0
Intangible asset amortization expense
5.6
5.6
Decrease in fair value of strategic investments
2.0
15.0
Increase in fair value of contingent consideration
0.2
2.2
Total non-GAAP adjustments to pre-tax income
174.2
567.9
Tax adjustments (2)
(58.6
)
(160.1
)
Non-GAAP net income
$
1,147.0
$
1,054.1
Net income per diluted common share:
GAAP
$
4.02
$
2.49
Non-GAAP
$
4.47
$
4.06
Shares used in diluted per share calculations:
GAAP and Non-GAAP
256.3
259.5
2: In the three months ended March 31, 2026 and 2025, “Tax adjustments” included the estimated income taxes related to non-GAAP adjustments to the company's pre-tax income and excess tax benefits related to stock-based compensation.
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Balance Sheets
(unaudited, in millions)
March 31, 2026
December 31, 2025
Assets
Cash, cash equivalents and marketable securities
$
7,246.7
$
6,608.1
Accounts receivable, net
1,996.1
2,052.8
Inventories
1,766.7
1,686.8
Prepaid expenses and other current assets
720.8
853.3
Total current assets
11,730.3
11,201.0
Property and equipment, net
1,608.4
1,520.3
Goodwill and other intangible assets, net
1,506.5
1,512.2
Deferred tax assets
2,947.8
2,897.9
Operating lease assets
1,685.1
1,562.7
Long-term marketable securities
5,749.9
5,712.3
Other long-term assets
1,256.4
1,236.6
Total assets
$
26,484.4
$
25,643.0
Liabilities and Shareholders' Equity
Accounts payable and accrued expenses
$
3,473.5
$
3,432.9
Other current liabilities
407.1
428.3
Total current liabilities
3,880.6
3,861.2
Long-term operating lease liabilities
1,986.5
1,846.5
Other long-term liabilities
1,255.4
1,269.5
Shareholders' equity
19,361.9
18,665.8
Total liabilities and shareholders' equity
$
26,484.4
$
25,643.0
Common shares outstanding
254.2
254.0
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America, and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit at www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief, or current expectation of Vertex and members of the Vertex senior management team. Forward-looking statements are not purely historical and may be accompanied by words such as “anticipates,” “may,” “forecasts,” “expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,” “estimates,” and other words and terms of similar meaning. Such statements include, without limitation, Dr. Kewalramani's statements in this press release, the information provided regarding future financial performance and operations, the section captioned “Full Year 2026 Financial Guidance” and statements regarding (i) expectations for $500 million or more in non-CF product revenue and an immaterial cost impact from tariffs in 2026, (ii) expectations for continued growth in CF, including by increasing the number of CF patients taking its medicines through new approvals and reimbursement agreements, treatment of younger patients, increased survival, and expansion into additional geographies, (iii) beliefs regarding Vertex’s work to secure access to ALYFTREK in additional countries, (iv) beliefs regarding the anticipated benefits, eligible patient population, and access to CASGEVY, (v) expectations regarding the potential benefits and access to JOURNAVX, and anticipated benefits of being added to the NOPAIN list, (vi) expectations to submit for approval with global regulators for ALYFTREK in children ages two to five years in the first half of 2026, and to enroll and dose in the pivotal study of ALYFTREK in children ages one to less than two years, (vii) expectations to complete dosing in the clinical trial evaluating VX-828 in the first half of 2026, plans to share VX-828 data in the second half of 2026, and expectations for the VX-581 and VX-272 studies, (viii) expectations for CASGEVY, including expectations for potential accelerated timelines for review of the FDA submission, and advancing preclinical assets for gentler conditioning for CASGEVY, which could broaden the eligible patient population, (ix) expectations to complete enrollment in both Phase 3 studies of suzetrigine in DPN by the end of 2026, plans for the Phase 2 study of VX-993 in DPN, and plans for advancement of additional preclinical assets that inhibit NaV1.7, (x) expectations with respect to povetacicept, including beliefs about its potential benefits and therapeutic scope, its potential to be a best-in-class approach to control B cell activity in IgAN, pMN and gMG, and its potential to be a pipeline-in-a-product, expectations regarding povetacicept in IgAN, including the anticipated expedited review of the BLA, and expectations for povetacicept in pMN, including with respect to enrollment and dosing in the study, (xi) expectations regarding the AMPLITUDE Phase 2/3 trial of inaxaplin in AMKD, including expectations regarding the interim analysis, plans to share data in early 2027, and expectations to complete full enrollment in the second half of 2026, and expectations to complete dosing in the AMPLIFIED Phase 2 study of inaxaplin and share data in the second half of 2026, (xii) expectations regarding the clinical benefits and goals for zimislecel in T1D, and expectations to provide updated timelines for study completion in 2026, (xiii) expectations regarding the ADPKD program and the Phase 2 study evaluating VX-407, including expectation to complete enrollment in the AGLOW study in the second half of 2026, (xiv) beliefs regarding the potential benefits and clinical status of VX-670 for the treatment in people with DM1 and expectations to complete enrollment and dosing in the trial and share results in the second half of 2026, and (xv) the company’s beliefs with respect to additional assets or approaches across its portfolio. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the company's expectations regarding its 2026 full year revenues, expenses, and effective tax rates and that impact from tariffs in 2026 may be incorrect (including because one or more of the company's assumptions underlying its expectations may not be realized), that we may be unable to further successfully commercialize ALYFTREK as a treatment for CF, JOURNAVX as a treatment for acute pain, and CASGEVY as a treatment for SCD and TDT, that external factors may have different or more significant impacts on the company's business or operations than the company currently expects, that data from preclinical testing or clinical trials, especially if based on a limited number of patients, may not be indicative of final results or available on anticipated timelines, that patient enrollment in the company’s trials may be delayed, that the company may not realize the anticipated benefits from collaborations with third parties, that data from the company's development programs may not support registration or further development of its potential medicines in a timely manner, or at all, due to safety, efficacy or other reasons, that regulatory submissions or approvals may not occur on the anticipated timeline, or at all, that interactions with regulators may cause delays in the company’s pipeline programs, and that anticipated commercial launches may be delayed, if they occur at all. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Vertex’s business, particularly those risks listed under the heading “Risk Factors” and the other cautionary factors discussed in Vertex’s periodic reports filed with the SEC, including Vertex’s annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, all of which are filed with the Securities and Exchange Commission (SEC) and available through the company's website at www.vrtx.com and on the SEC’s website at www.sec.gov. You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
Conference Call and Webcast
The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (833) 630-2124 (U.S.) or +1(412) 317-0651 (International) and reference the “Vertex Pharmaceuticals First Quarter 2026 Earnings Call.”
The conference call will be webcast live and a link to the webcast can be accessed through Vertex's website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company's website.
Vertex Pharmaceuticals on Monday beat Wall Street estimates for first-quarter adjusted profit, helped by a near eight-fold surge in sales of its new cystic fibrosis treatment.
Vertex Pharmaceuticals Inc (NASDAQ:VRTX) reported mixed financial results for the first quarter after the market close on Monday.
Vertex reported first-quarter revenue of $2.99 billion, missing analyst estimates of $3.03 billion, according to Benzinga Pro. The company posted first-quarter adjusted earnings of $4.47 per share, beating estimates of $4.31 per share.
"CASGEVY and JOURNAVX delivered more than 25 percent of our growth this quarter, underscoring the strength of the increasingly diversified revenue base. As we execute across the commercial portfolio and pipeline and build our fourth franchise in nephrology, Vertex is poised to continue to deliver for patients and create long-term value," said Reshma Kewalramani, president and CEO of Vertex.
Vertex affirmed its full-year revenue guidance of $12.95 billion to $13.10 billion versus estimates of $13.06 billion.
Vertex shares fell 2.7% to trade at $418.83 on Tuesday.
These analysts made changes to their price targets on Vertex following earnings announcement.
RBC Capital analyst Brian Abrahams maintained the stock with an Outperform rating and raised the price target from $541 to $543. Bernstein analyst William Pickering maintained the stock with an Outperform rating and lowered the price target from $577 to $572. Considering buying VRTX stock? Here’s what analysts think:
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-The agreement ensures sustainable access to this innovative therapy for eligible patients ages 12 years and older in Germany-
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that a reimbursement agreement was signed with the GKV-Spitzenverband for its CRISPR/Cas9 gene-edited therapy, CASGEVY® (exagamglogene autotemcel). This agreement secures sustainable access to this innovative one-time treatment for eligible patients in Germany ages 12 years and older living with severe sickle cell disease or transfusion-dependent beta thalassemia.
“For the first time in Germany, a long-term, sustainable access agreement to a gene therapy has been established for people living with sickle cell disease and transfusion-dependent beta thalassemia,” said Ludovic Fenaux, Senior Vice President, Vertex International. “This agreement represents significant progress for people living with these two devastating and life-shortening diseases. We are pleased to collaborate across the health care system to ensure the value of CASGEVY is recognized and sustainable patient access is secured.”
With this agreement, Germany joins a growing number of countries that have reimbursed CASGEVY, including Austria, Denmark, Italy, the Kingdom of Saudi Arabia, the United Arab Emirates, the United Kingdom and the United States. Vertex remains committed to working with government and reimbursement authorities globally to ensure sustainable access for eligible patients.
About Sickle Cell Disease (SCD)
SCD is a debilitating, progressive, life-shortening genetic disease. SCD patients report health-related quality of life scores well below the general population and significant health care resource utilization. SCD affects the red blood cells, which are essential for carrying oxygen to all organs and tissues of the body. SCD causes severe pain, organ damage and shortened life span due to misshapen or “sickled” red blood cells. The clinical hallmark of SCD is vaso-occlusive crises (VOCs), which are caused by blockages of blood vessels by sickled red blood cells and result in severe and debilitating pain that can happen anywhere in the body at any time. SCD requires lifelong treatment and significant use of health care resources, and ultimately results in reduced life expectancy, decreased quality of life and reduced lifetime earnings and productivity. In Europe, the mean age of death for patients living with SCD is around 40 years.
About Transfusion-Dependent Beta Thalassemia (TDT)
TDT is a serious, life-threatening genetic disease. TDT patients report health-related quality of life scores below the general population and significant health care resource utilization. TDT requires frequent blood transfusions and iron chelation therapy throughout a person’s life. Due to anemia, patients living with TDT may experience fatigue and shortness of breath, and infants may develop failure to thrive, jaundice and feeding problems. Complications of TDT can also include an enlarged spleen, liver and/or heart, misshapen bones and delayed puberty. TDT requires lifelong treatment and significant use of health care resources, and ultimately results in reduced life expectancy, decreased quality of life and reduced lifetime earnings and productivity. In Europe, the mean age of death for patients living with TDT is 50-55 years.
About CASGEVY® (exagamglogene autotemcel)
CASGEVY® is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene through a precise double-strand break. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT.
CASGEVY is approved for eligible SCD and TDT patients 12 years and older by multiple regulatory bodies around the world. In the European Union, CASGEVY is approved for patients 12 years of age and older with either severe SCD with recurrent VOCs or TDT, for whom hematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen matched related HSC donor is not available.
For complete product information, please see the Summary of Product Characteristics (SmPC) at www.ema.europa.eu.
U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR CASGEVY
WHAT IS CASGEVY?
CASGEVY is a one-time therapy used to treat people ages 12 years and older with:
sickle cell disease (SCD) who have frequent vaso-occlusive crises or VOCs beta thalassemia (β-thalassemia) who need regular blood transfusions CASGEVY is made specifically for each patient, using the patient’s own edited blood stem cells, and increases the production of a special type of hemoglobin called hemoglobin F (fetal hemoglobin or HbF). Having more HbF increases overall hemoglobin levels and has been shown to improve the production and function of red blood cells. This can eliminate VOCs in people with sickle cell disease and eliminate the need for regular blood transfusions in people with beta thalassemia.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about CASGEVY?
After treatment with CASGEVY, you will have fewer blood cells for a while until CASGEVY takes hold (engrafts) into your bone marrow. This includes low levels of platelets (cells that usually help the blood to clot) and white blood cells (cells that usually fight infections). Your doctor will monitor this and give you treatment as required. The doctor will tell you when blood cell levels return to safe levels.
Tell your healthcare provider right away if you experience any of the following, which could be signs of low levels of platelet cells: severe headache abnormal bruising prolonged bleeding bleeding without injury such as nosebleeds; bleeding from gums; blood in your urine, stool, or vomit; or coughing up blood Tell your healthcare provider right away if you experience any of the following, which could be signs of low levels of white blood cells: fever chills infections You may experience side effects associated with other medicines administered as part of the treatment regimen for CASGEVY. Talk to your physician regarding those possible side effects. Your healthcare provider may give you other medicines to treat your side effects.
How will I receive CASGEVY?
Your healthcare provider will give you other medicines, including a conditioning medicine, as part of your treatment with CASGEVY. It’s important to talk to your healthcare provider about the risks and benefits of all medicines involved in your treatment.
After receiving the conditioning medicine, it may not be possible for you to become pregnant or father a child. You should discuss options for fertility preservation with your healthcare provider before treatment.
STEP 1: Before CASGEVY treatment, a doctor will give you mobilization medicine(s). This medicine moves blood stem cells from your bone marrow into the blood stream. The blood stem cells are then collected in a machine that separates the different blood cells (this is called apheresis). This entire process may happen more than once. Each time, it can take up to one week.
During this step rescue cells are also collected and stored at the hospital. These are your existing blood stem cells and are kept untreated just in case there is a problem in the treatment process. If CASGEVY cannot be given after the conditioning medicine, or if the modified blood stem cells do not take hold (engraft) in the body, these rescue cells will be given back to you. If you are given rescue cells, you will not have any treatment benefit from CASGEVY.
STEP 2: After they are collected, your blood stem cells will be sent to the manufacturing site where they are used to make CASGEVY. It may take up to 6 months from the time your cells are collected to manufacture and test CASGEVY before it is sent back to your healthcare provider.
STEP 3: Shortly before your stem cell transplant, your healthcare provider will give you a conditioning medicine for a few days in hospital. This will prepare you for treatment by clearing cells from the bone marrow, so they can be replaced with the modified cells in CASGEVY. After you are given this medicine, your blood cell levels will fall to very low levels. You will stay in the hospital for this step and remain in the hospital until after the infusion with CASGEVY.
STEP 4: One or more vials of CASGEVY will be given into a vein (intravenous infusion) over a short period of time.
After the CASGEVY infusion, you will stay in hospital so that your healthcare provider can closely monitor your recovery. This can take 4-6 weeks, but times can vary. Your healthcare provider will decide when you can go home.
What should I avoid after receiving CASGEVY?
Do not donate blood, organs, tissues, or cells at any time in the future What are the possible or reasonably likely side effects of CASGEVY?
The most common side effects of CASGEVY include:
Low levels of platelet cells, which may reduce the ability of blood to clot and may cause bleeding Low levels of white blood cells, which may make you more susceptible to infection Your healthcare provider will test your blood to check for low levels of blood cells (including platelets and white blood cells). Tell your healthcare provider right away if you get any of the following symptoms:
fever chills infections severe headache abnormal bruising prolonged bleeding bleeding without injury such as nosebleeds; bleeding from gums; blood in your urine, stool, or vomit; or coughing up blood These are not all the possible side effects of CASGEVY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of CASGEVY
Talk to your healthcare provider about any health concerns.
Please see full Prescribing Information including Patient Information for CASGEVY.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.
Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the statements by Ludovic Fenaux, in this press release, and statements regarding Vertex’s expectations for the benefits of CASGEVY, expectations for access to CASGEVY for eligible patients in Germany, and Vertex’s plans to continue working with government and reimbursement authorities globally to ensure sustainable access for eligible patients. While we believe the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy, and other reasons, anticipated patient populations may be different than expected, and other risks listed under the heading “Risk Factors” in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company's website at www.vrtx.com. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
Vertex Pharmaceuticals Incorporated delivered strong Q1 2026 earnings, with $2.99bn revenue and $4.02 EPS, but revenue growth is slowing as CF market saturates. VRTX's cystic fibrosis franchise remains dominant and highly profitable, but diversification efforts—Casgevy, Journavx, and povetacicept—face slow uptake or intense competition. Forward P/E of ~26.5x and P/S of ~8.3x are above Big Pharma averages, reflecting market concerns about future growth for VRTX beyond CF.
KING OF PRUSSIA, Pa., May 07, 2026 (GLOBE NEWSWIRE) -- Vertex, Inc. (NASDAQ: VERX) (“Vertex” or the “Company”), a leading provider of enterprise compliance technology for global commerce, today announced financial results for its first quarter ended March 31, 2026.
“We delivered a strong first quarter, with revenue and adjusted EBITDA above the higher end of our guidance as well as stability across customer demand and retention,” said Chris Young, President and Chief Executive Officer of Vertex. “As we exited the quarter, we were encouraged by consistent customer behavior and solid execution across the business, even within a mixed macro environment.”
Mr. Young continued, “In addition, in the first quarter we acquired Brinta, an AI-first e-invoicing startup in Latin America. The acquisition of Brinta enables us to expedite our country coverage in Latin America while bringing an AI-native architecture built for one of the most complex real-time compliance environments in the world. That capability includes automation with control and speed with auditability which is where global compliance is heading.”
Mr. Young concluded, “In April, we announced our Value Creation Plan, which is expected to further transform Vertex into a more effective, AI-leading organization. The Value Creation Plan is expected to accelerate profitability and free cash flow while providing resources to invest in the opportunities that matter most. This is not a short-term cost exercise—it is a deliberate reset designed to build a stronger, more profitable foundation that gives us greater flexibility to invest in innovation and long-term growth. We remain confident in the strength of our customer relationships, our market position, and the significant opportunity ahead.”
First Quarter 2026 Financial Results
Total revenues of $196.6 million, up 11.1% year-over-year.Software subscription revenues of $167.1 million, up 10.9% year-over-year.Cloud revenues of $96.8 million, up 20.7% year-over-year.Annual Recurring Revenue (“ARR”) was $687.6 million, up 11.2% year-over-year.Average Annual Revenue per direct customer (“AARPC”) was $140,464 at March 31, 2026, compared to $126,534 at March 31, 2025, and $137,867 at December 31, 2025.Net Revenue Retention (“NRR”) was 105%, compared to 109% at March 31, 2025, and 105% at December 31, 2025.Gross Revenue Retention (“GRR”) was 95%, compared to 95% at March 31, 2025, and 94% at December 31, 2025.Income (loss) from operations of $(10.6) million, compared to $4.5 million for the same period in the prior year.Non-GAAP operating income of $37.6 million, compared to $31.3 million for the same period in the prior year.Net income (loss) of $(2.5) million, compared to $11.1 million for the same period in the prior year.Net loss per basic and diluted Class A and Class B shares of $0.02, compared to net income per basic and diluted Class A and Class B shares of $0.07 for the same period in the prior year.Non-GAAP net income of $28.7 million and Non-GAAP diluted earnings per share (“EPS”) of $0.17.Adjusted EBITDA of $44.1 million, compared to $37.2 million for the same period in the prior year. Adjusted EBITDA margin of 22.4%, compared to 21.0% for the same period in the prior year. Definitions of certain key business metrics and the non-GAAP financial measures used in this press release and reconciliations of such measures to the most directly comparable GAAP financial measures are included below under the headings “Definitions of Certain Key Business Metrics” and “Use and Reconciliation of Non-GAAP Financial Measures.”
Financial Outlook
For the second quarter of 2026, the Company currently expects:
Revenues of $200.0 million to $204.0 million;Adjusted EBITDA of $47.0 million to $50.0 million. For the full-year 2026, the Company currently expects:
Revenues of $823.5 million to $831.5 million;Cloud revenue growth of 25 percent; andAdjusted EBITDA of $202.0 million to $208.0 million. John Schwab, Chief Financial Officer added, “The cost actions we took in April due to the Value Creation Plan are expected to significantly increase earnings leverage in 2026 and beyond. Accordingly, we are increasing our Adjusted EBITDA guidance for the full year. On a fully annualized basis we expect the cost actions to save approximately $60 to $70 million dollars of cash spend beginning in 2027.”
The Company is unable to reconcile forward-looking Adjusted EBITDA to net income (loss), the most directly comparable GAAP financial measure, without unreasonable efforts because the Company is currently unable to predict with a reasonable degree of certainty the type and extent of certain items that would be expected to impact net income (loss) for these periods but would not impact Adjusted EBITDA. Such items may include stock-based compensation expense, depreciation and amortization of capitalized software costs and acquired intangible assets, severance expense, acquisition contingent consideration, changes in the fair value of acquisition contingent earn-outs, amortization of cloud computing implementation costs, severance expenses, acquisition-related retained employee compensation, transaction costs, and other items. The unavailable information could have a significant impact on the Company’s net income (loss). The foregoing forward-looking statements reflect the Company’s expectations as of today’s date. Given the number of risk factors, uncertainties and assumptions discussed below, actual results may differ materially. The Company does not intend to update its financial outlook until its next quarterly results announcement.
Important disclosures in this earnings release about and reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are provided below under “Use and Reconciliation of Non-GAAP Financial Measures.”
Conference Call and Webcast Information
Vertex will host a conference call at 8:30 a.m. Eastern Time today, May 7, 2026, to discuss its first quarter 2026 financial results.
Those wishing to participate should register in advance for the live conference call at https://vertex-earnings-q1-2026.open-exchange.net/registration.
A live webcast of the call will also be available at the Company’s investor relations website at https://ir.vertexinc.com. An audio-only replay of the conference call will be available on the investor relations website for one year.
About Vertex
Vertex, Inc. is a leading global provider of indirect tax solutions. The Company’s mission is to deliver the most trusted tax technology enabling global businesses to transact, comply and grow with confidence. Vertex provides solutions that can be tailored to specific industries for major lines of indirect tax, including sales and consumer use, value added and payroll. Headquartered in North America, and with offices in South America and Europe, Vertex empowers the world’s leading brands to simplify the complexity of continuous compliance.
For more information, visit www.vertexinc.com; follow us on X and LinkedIn; or subscribe on YouTube.
Forward-Looking Statements
Any statements made in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies, and our stock repurchase program. Forward-looking statements are based on Vertex management’s beliefs, as well as assumptions made by, and information currently available to, them. Because such statements are based on expectations as to future financial and operating results and are not statements of fact, actual results may differ materially from those projected. Factors which may cause actual results to differ materially from current expectations include, but are not limited to: our ability to maintain and grow revenue from existing customers and new customers, and expand their usage of our solutions; our ability to maintain and expand our strategic relationships with third parties; our ability to adapt to technological change and successfully introduce new solutions or provide updates to existing solutions; risks related to failures in information technology or infrastructure; risks related to our reliance on government infrastructure to support our e-invoicing services; challenges in using and managing use of Artificial Intelligence in our business; incorrect or improper implementation, integration or use of our solutions; failure to attract and retain qualified technical and tax-content personnel; competitive pressures from other tax software and service providers and challenges of convincing businesses using native enterprise resource planning functions to switch to our software; our ability to accurately forecast our revenue and other future results of operations based on recent success; our ability to offer specific software deployment methods based on changes to customers’ and partners’ software systems; our ability to continue making significant investments in software development and equipment; our ability to sustain and expand revenues, maintain profitability, and to effectively manage our anticipated growth; our ability to successfully diversify our solutions by developing or introducing new solutions or acquiring and integrating additional businesses, products, services, or content; our ability to successfully integrate acquired businesses and to realize the anticipated benefits of such acquisitions; risks related to the fluctuations in our results of operations; risks related to our expanding international operations; our exposure to liability from errors, delays, fraud or system failures, which may not be covered by insurance; our ability to adapt to organizational changes and effectively implement strategic initiatives; risks related to our determinations of customers’ transaction tax and tax payments; risks related to changes in tax laws and regulations or their interpretation or enforcement; our ability to manage cybersecurity and data privacy risks; our involvement in material legal proceedings and audits; risks related to undetected errors, bugs or defects in our software; risks related to utilization of open-source software, business processes and information systems; our ability to effectively protect, maintain, and enhance our brand; changes in application, scope, interpretation or enforcement of laws and regulations; global economic weakness and uncertainties, including the economic uncertainty created by the changing legal, regulatory, or taxation landscape in the United States, and disruption in the capital and credit markets; business disruptions related to natural disasters, epidemic outbreaks, including a global endemic or pandemic, terrorist acts, political events, or other events outside of our control; our ability to comply with anti-corruption, anti-bribery, and similar laws; our ability to protect our intellectual property; changes in interest rates, security ratings and market perceptions of the industry in which we operate, or our ability to obtain capital on commercially reasonable terms or at all; our ability to maintain an effective system of disclosure controls and internal control over financial reporting, or ability to remediate any material weakness in our internal controls; risks related to our Class A common stock and controlled company status; risks related to our stock repurchase program; risks related to our indebtedness and adherence to the covenants under our debt instruments; our expectations regarding the effects of the Capped Call Transactions (as defined in our Form 10-K) and regarding actions of the Option Counterparties (as defined in our Form 10-K) and/or their respective affiliates; risks associated with our Value Creation Plan; and the other factors described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 (“Form 10-K”), filed with the Securities and Exchange Commission (the “SEC”) on February 24, 2026, as may be subsequently updated by our other SEC filings. Copies of such filings may be obtained from the Company or the SEC.
All forward-looking statements reflect our beliefs and assumptions only as of the date of this press release. We undertake no obligation to update forward-looking statements to reflect future events or circumstances.
Definitions of Certain Key Business Metrics
Annual Recurring Revenue (“ARR”)
We derive the vast majority of our revenues from recurring software subscriptions. We believe ARR provides us with visibility to our projected software subscription revenues in order to evaluate the health of our business. Because we recognize subscription revenues ratably, we believe investors can use ARR to measure our expansion of existing customer revenues, new customer activity, and as an indicator of future software subscription revenues. ARR is based on monthly recurring revenues (“MRR”) from software subscriptions for the most recent month at period end, multiplied by twelve. MRR is calculated by dividing the software subscription price, inclusive of discounts, by the number of subscription covered months. MRR only includes direct customers with MRR at the end of the last month of the measurement period. AARPC represents average annual revenue per direct customer and is calculated by dividing ARR by the number of software subscription direct customers at the end of the respective period.
Net Revenue Retention (“NRR”)
We believe that our NRR provides insight into our ability to retain and grow revenues from our direct customers, as well as their potential long-term value to us. We also believe it demonstrates to investors our ability to expand existing customer revenues, which is one of our key growth strategies. Our NRR refers to the ARR expansion during the 12 months of a reporting period for all direct customers who were part of our customer base at the beginning of the reporting period. Our NRR calculation takes into account any revenues lost from departing direct customers or those who have downgraded or reduced usage, as well as any revenue expansion from migrations, new licenses for additional products or contractual and usage-based price changes.
Gross Revenue Retention (“GRR”)
We believe our GRR provides insight into and demonstrates to investors our ability to retain revenues from our existing direct customers. Our GRR refers to how much of our MRR we retain each month after reduction for the effects of revenues lost from departing direct customers or those who have downgraded or reduced usage. GRR does not take into account revenue expansion from migrations, new licenses for additional products or contractual and usage-based price changes. GRR does not include revenue reductions resulting from cancellations of customer subscriptions that are replaced by new subscriptions associated with customer migrations to a newer version of the related software solution.
Customer Count
The following table shows Vertex’s direct customers, as well as indirect small business customers sold and serviced through the Company’s one-to-many channel strategy.
CustomersQ1 2025Q2 2025Q3 2025Q4 2025Q1 2026Direct4,8884,8624,8564,8674,895Indirect481504516515530Total5,3695,3665,3725,3825,425
Use and Reconciliation of Non-GAAP Financial Measures
In addition to our results determined in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and key business metrics described above, we have calculated non-GAAP cost of revenues, non-GAAP gross profit, non-GAAP gross margin, non-GAAP research and development expense, non-GAAP selling and marketing expense, non-GAAP general and administrative expense, non-GAAP operating income, non-GAAP net income, non-GAAP diluted EPS, Adjusted EBITDA, Adjusted EBITDA margin, free cash flow and free cash flow margin, which are each non-GAAP financial measures. We have provided tabular reconciliations of each of these non-GAAP financial measures to its most directly comparable GAAP financial measure.
Management uses these non-GAAP financial measures to understand and compare operating results across accounting periods, for internal budgeting and forecasting purposes, and to evaluate financial performance and liquidity. Our non-GAAP financial measures are presented as supplemental disclosure as we believe they provide useful information to investors and others in understanding and evaluating our results, prospects, and liquidity period-over-period without the impact of certain items that do not directly correlate to our operating performance and that may vary significantly from period to period for reasons unrelated to our operating performance, as well as comparing our financial results to those of other companies. Our definitions of these non-GAAP financial measures may differ from similarly titled measures presented by other companies and therefore comparability may be limited. In addition, other companies may not publish these or similar metrics. Thus, our non-GAAP financial measures should be considered in addition to, not as a substitute for, or in isolation from, the financial information prepared in accordance with GAAP, and should be read in conjunction with the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on February 24, 2026 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, to be filed with the SEC.
We calculate these non-GAAP financial measures as follows:
Non-GAAP cost of revenues, software subscriptions is determined by adding back to GAAP cost of revenues, software subscriptions, the stock-based compensation expense, and depreciation and amortization of capitalized software and acquired intangible assets included in cost of subscription revenues for the respective periods.Non-GAAP cost of revenues, services is determined by adding back to GAAP cost of revenues, services, the stock-based compensation expense included in cost of revenues, services for the respective periods.Non-GAAP gross profit is determined by adding back to GAAP gross profit the stock-based compensation expense, and depreciation and amortization of capitalized software and acquired intangible assets included in cost of subscription revenues for the respective periods.Non-GAAP gross margin is determined by dividing non-GAAP gross profit by total revenues for the respective periods.Non-GAAP research and development expense is determined by adding back to GAAP research and development expense the stock-based compensation expense and transaction costs related to acquired technology included in research and development expense for the respective periods.Non-GAAP selling and marketing expense is determined by adding back to GAAP selling and marketing expense the stock-based compensation expense and the amortization of acquired intangible assets included in selling and marketing expense for the respective periods.Non-GAAP general and administrative expense is determined by adding back to GAAP general and administrative expense the stock-based compensation expense, amortization of cloud computing implementation costs, severance expense, acquisition-related retained employee compensation, and transaction costs included in general and administrative expense for the respective periods.Non-GAAP operating income is determined by adding back to GAAP loss or income from operations the stock-based compensation expense, depreciation and amortization of capitalized software and acquired intangible assets, amortization of cloud computing implementation costs, severance expense, acquisition contingent consideration, changes in the fair value of acquisition contingent earn-outs, acquisition-related retained employee compensation, and transaction costs included in GAAP loss or income from operations for the respective periods.Non-GAAP net income is determined by adding back to GAAP net income or loss income tax benefit or expense, stock-based compensation expense, depreciation and amortization of capitalized software and acquired intangible assets, amortization of cloud computing implementation costs, severance expense, acquisition contingent consideration, changes in the fair value of acquisition contingent earn-outs, acquisition-related retained employee compensation, and transaction costs included in GAAP loss or income from operations for the respective periods, to determine non-GAAP income or loss before income taxes. Non-GAAP income or loss before income taxes is then adjusted for income taxes calculated using the respective statutory tax rates for applicable jurisdictions, which for purposes of this determination were assumed to be 25.5%.Non-GAAP net income per diluted share of Class A and Class B common stock (“Non-GAAP diluted EPS”) is determined by dividing non-GAAP net income by the weighted average shares outstanding of all classes of common stock, inclusive of the impact of dilutive common stock equivalents to purchase such common stock, including stock options, restricted stock awards, restricted stock units and employee stock purchase plan shares. Additionally, the dilutive effect of shares issuable upon conversion of the senior convertible notes is included in the calculation of Non-GAAP diluted EPS by application of the if-converted method.Adjusted EBITDA is determined by adding back to GAAP net income or loss the net interest income or expense, income tax expense or benefit, depreciation and amortization of property and equipment, depreciation and amortization of capitalized software and acquired intangible assets, amortization of cloud computing implementation costs, severance expense, acquisition contingent consideration, changes in the fair value of acquisition contingent earn-outs, acquisition-related retained employee compensation, and transaction costs included in GAAP net income or loss for the respective periods.Adjusted EBITDA margin is determined by dividing Adjusted EBITDA by total revenues for the respective periods.Free cash flow is determined by adjusting net cash provided by (used in) operating activities by purchases of property and equipment and capitalized software additions for the respective periods.Free cash flow margin is determined by dividing free cash flow by total revenues for the respective periods. We encourage investors and others to review our financial information in its entirety, not to rely on any single financial measure and to view these non-GAAP financial measures in conjunction with the related GAAP financial measures.
Vertex, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited) As of March 31, As of December 31,(In thousands, except per share data) 2026
2025
(unaudited) Assets Current assets: Cash and cash equivalents $252,455 $314,009 Funds held for customers 17,698 24,286 Accounts receivable, net of allowance of $13,225 and $11,466, respectively 158,998 183,446 Prepaid expenses and other current assets 59,358 38,966 Total current assets 488,509 560,707 Property and equipment, net of accumulated depreciation 220,407 209,727 Capitalized software, net of accumulated amortization 35,253 35,480 Goodwill and other intangible assets 405,355 396,006 Deferred commissions 30,879 31,907 Deferred income tax asset 129 85 Operating lease right-of-use assets 8,830 9,678 Long-term investment 15,000 15,000 Other assets 10,006 12,245 Total assets $1,214,368 $1,270,835 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $35,630 $37,557 Accrued expenses 36,607 43,642 Customer funds obligations 15,180 21,802 Accrued salaries and benefits 32,199 23,992 Accrued variable compensation 16,682 34,593 Deferred revenue, current 393,107 382,839 Current portion of operating lease liabilities 4,327 4,283 Current portion of finance lease liabilities 44 55 Purchase commitment and contingent consideration liabilities, current 32,800 25,900 Total current liabilities 566,576 574,663 Deferred revenue, net of current portion 5,290 5,209 Debt, net of current portion 338,041 337,477 Operating lease liabilities, net of current portion 7,686 8,903 Finance lease liabilities, net of current portion 46 54 Purchase commitment and contingent consideration liabilities, net of current portion 41,300 79,600 Deferred income tax liabilities 8,925 5,664 Deferred other liabilities — 345 Total liabilities 967,864 1,011,915 Stockholders' equity: Preferred shares, $0.001 par value, 30,000 shares authorized; no shares issued and outstanding — — Class A voting common stock, $0.001 par value, 300,000 shares authorized; 78,882 and 77,580 shares issued and outstanding, respectively 79 77 Class B voting common stock, $0.001 par value, 150,000 shares authorized; 82,156 and 82,156 shares issued and outstanding, respectively 82 82 Treasury stock, at cost, 1,875 and 504 shares, respectively (30,135) (10,094)Additional paid in capital 332,910 316,327 Accumulated deficit (48,614) (46,104)Accumulated other comprehensive loss (7,818) (1,368)Total stockholders' equity 246,504 258,920 Total liabilities and stockholders' equity $1,214,368 $1,270,835 Vertex, Inc. and Subsidiaries
Consolidated Statements of Comprehensive Income (Loss)
(Unaudited) Three months ended March 31,(In thousands, except per share data)2026 2025 (unaudited)Revenues: Software subscriptions$167,146 $150,761 Services 29,500 26,301 Total revenues 196,646 177,062 Cost of revenues: Software subscriptions 51,176 44,245 Services 20,601 19,823 Total cost of revenues 71,777 64,068 Gross profit 124,869 112,994 Operating expenses: Research and development 24,550 20,886 Selling and marketing 52,635 48,155 General and administrative 54,339 45,028 Depreciation and amortization 6,442 5,880 Change in fair value of acquisition contingent earn-outs (5,738) (14,700)Other operating expense, net 3,247 3,259 Total operating expenses 135,475 108,508 Income (loss) from operations (10,606) 4,486 Interest income, net (957) (1,539)Income (loss) before income taxes (9,649) 6,025 Income tax benefit (7,139) (5,105)Net income (loss) (2,510) 11,130 Other comprehensive (income) loss: Foreign currency translation adjustments, net of tax 6,450 (15,105)Unrealized loss on investments, net of tax — 9 Total other comprehensive income (loss), net of tax 6,450 (15,096)Total comprehensive income (loss)$(8,960) $26,226 Net income (loss) per share of Class A and Class B, basic$(0.02) $0.07 Net income (loss) per share of Class A and Class B, diluted$(0.02) $0.07 Vertex, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited) Three months ended March 31,(In thousands) 2026 2025 (unaudited)Cash flows from operating activities: Net income (loss) $(2,510) $11,130 Adjustments to reconcile net income (loss) to net cash provided by operating activities: Depreciation and amortization 27,053 22,266 Amortization of cloud computing implementation costs 1,037 1,006 Provision for subscription cancellations and non-renewals 936 192 Amortization of deferred financing costs 680 680 Change in fair value of contingent consideration liabilities (5,738) (14,700)Stock-based compensation expense 18,508 21,044 Deferred income taxes 1,810 (929)Non-cash operating lease costs 1,773 779 Other 1 (7)Changes in operating assets and liabilities, net of the effects of business acquisition(s): Accounts receivable 23,396 11,772 Prepaid expenses and other current assets (21,449) (13,169)Deferred commissions 1,028 (56)Accounts payable (1,968) (11,279)Accrued expenses (7,341) 2,956 Accrued and deferred compensation (10,562) (26,785)Deferred revenue 11,247 11,156 Operating lease liabilities (2,083) (1,068)Other 2,157 (183)Net cash provided by operating activities 37,975 14,805 Cash flows from investing activities: Acquisition of businesses and assets, net of cash acquired (21,968) — Property and equipment additions (24,660) (21,394)Capitalized software additions (5,656) (5,661)Purchase of investment securities, available-for-sale — (2,398)Proceeds from sales and maturities of investment securities, available-for-sale — 11,607 Net cash used in investing activities (52,284) (17,846)Cash flows from financing activities: Net increase (decrease) in customer funds obligations (6,621) 3,227 Repurchases of shares (20,041) — Payments for taxes related to net share settlement of stock-based awards (7,143) (25,034)Proceeds from exercise of stock options 97 1,166 Payments for acquisition contingent cash earn-out (19,600) — Payments of finance lease liabilities (20) (12)Net cash used in financing activities (53,328) (20,653)Effect of exchange rate changes on cash, cash equivalents and restricted cash (505) 1,310 Net decrease in cash, cash equivalents and restricted cash (68,142) (22,384)Cash, cash equivalents and restricted cash, beginning of period 338,295 326,066 Cash, cash equivalents and restricted cash, end of period $270,153 $303,682 Reconciliation of cash, cash equivalents and restricted cash to the Condensed Consolidated Balance Sheets, end of period: Cash and cash equivalents $252,455 $270,395 Restricted cash—funds held for customers 17,698 33,287 Total cash, cash equivalents and restricted cash, end of period $270,153 $303,682 Summary of Non-GAAP Financial Measures
(Unaudited) Three months ended March 31, (Dollars in thousands, except per share data) 2026 2025 Non-GAAP cost of revenues, software subscriptions $29,345 $26,163 Non-GAAP cost of revenues, services $18,930 $18,127 Non-GAAP gross profit $148,371 $132,772 Non-GAAP gross margin 75.5 % 75.0 %Non-GAAP research and development expense $20,684 $16,534 Non-GAAP selling and marketing expense $46,767 $41,818 Non-GAAP general and administrative expense $37,044 $36,602 Non-GAAP operating income $37,621 $31,339 Non-GAAP net income $28,741 $24,494 Non-GAAP diluted EPS $0.17 $0.15 Adjusted EBITDA $44,063 $37,219 Adjusted EBITDA margin 22.4 % 21.0 %Free cash flow $7,659 $(12,250) Free cash flow margin 3.9 % (6.9)% Vertex, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited) Three months ended March 31, (Dollars in thousands) 2026
2025
Non-GAAP Cost of Revenues, Software Subscriptions: Cost of revenues, software subscriptions $51,176 $44,245 Stock-based compensation expense (1,745) (2,227) Depreciation and amortization of capitalized software and acquired intangible assets – cost of subscription revenues (20,086) (15,855) Non-GAAP cost of revenues, software subscriptions $29,345 $26,163 Non-GAAP Cost of Revenues, Services: Cost of revenues, services $20,601 $19,823 Stock-based compensation expense (1,671) (1,696) Non-GAAP cost of revenues, services $18,930 $18,127 Non-GAAP Gross Profit: Gross profit $124,869 $112,994 Stock-based compensation expense 3,416 3,923 Depreciation and amortization of capitalized software and acquired intangible assets – cost of subscription revenues 20,086 15,855 Non-GAAP gross profit $148,371 $132,772 Non-GAAP Gross Margin: Total Revenues $196,646 $177,062 Non-GAAP gross margin 75.5 % 75.0 % Non-GAAP Research and Development Expense: Research and development expense $24,550 $20,886 Stock-based compensation expense (3,866) (4,352) Non-GAAP research and development expense $20,684 $16,534 Non-GAAP Selling and Marketing Expense: Selling and marketing expense $52,635 $48,155 Stock-based compensation expense (5,343) (5,806) Amortization of acquired intangible assets – selling and marketing expense (525) (531) Non-GAAP selling and marketing expense $46,767 $41,818 Non-GAAP General and Administrative Expense: General and administrative expense $54,339 $45,028 Amortization of cloud computing implementation costs – general and administrative expense (1,037) (1,006) Stock-based compensation expense (5,883) (6,963) Severance expense(1) (7,408) (457) Acquisition-related retained employee compensation(2) (417) — Transaction costs(3) (2,550) — Non-GAAP general and administrative expense $37,044 $36,602 Vertex, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP Financial Measures (continued)
(Unaudited) Three months ended March 31,(In thousands, except per share data) 2026 2025Non-GAAP Operating Income: Income (loss) from operations $(10,606) $4,486 Stock-based compensation expense 18,508 21,044 Depreciation and amortization of capitalized software and acquired intangible assets – cost of subscription revenues 20,086 15,855 Amortization of acquired intangible assets – selling and marketing expense 525 531 Amortization of cloud computing implementation costs – general and administrative expense 1,037 1,006 Severance expense(1) 7,408 457 Change in fair value of acquisition contingent earn-outs (5,738) (14,700)Acquisition-related retained employee compensation(2) 417 — Transaction costs(3) 5,984 2,660 Non-GAAP operating income $37,621 $31,339 Non-GAAP Net Income: Net income (loss) $(2,510) $11,130 Income tax benefit (7,139) (5,105)Stock-based compensation expense 18,508 21,044 Depreciation and amortization of capitalized software and acquired intangible assets – cost of subscription revenues 20,086 15,855 Amortization of acquired intangible assets – selling and marketing expense 525 531 Amortization of cloud computing implementation costs – general and administrative expense 1,037 1,006 Severance expense(1) 7,408 457 Change in fair value of acquisition contingent earn-outs (5,738) (14,700)Acquisition-related retained employee compensation(2) 417 — Transaction costs(3) 5,984 2,660 Non-GAAP income before income taxes 38,578 32,878 Income tax adjustment at statutory rate(4) (9,837) (8,384)Non-GAAP net income $28,741 $24,494 Non-GAAP Diluted EPS: Non-GAAP net income $28,741 $24,494 Interest expense (net of tax), convertible senior notes(5) 903 903 Non-GAAP net income used in dilutive per share computation $29,644 $25,397 Weighted average Class A and B common stock, diluted 161,283 162,724 Dilutive effect of convertible senior notes(5) 9,498 9,498 Total average Class A and B shares used in dilutive per share computation 170,781 172,222 Non-GAAP diluted EPS $0.17 $0.15 (1) The three months ended March 31, 2026 includes $6,170 in severance costs related to the Value Creation Plan.(2) The three months ended March 31, 2026 includes compensation expense recognized related to the additional cash consideration payments of $10,000 to the sellers in connection with the acquisition of Brinta (the “Additional Cash Consideration”).(3) The three months ended March 31, 2026 and 2025 include legal expenses associated with pending litigation related to claims the Company has made against a competitor. The three months ended March 31, 2026 also includes $2,550 in costs incurred to support the execution of our Value Creation Plan.(4) Non-GAAP income before income taxes is adjusted for income taxes using the respective statutory tax rates for applicable jurisdictions, which for purposes of this determination were assumed to be 25.5%.(5) We use the if-converted method to compute diluted earnings per share with respect to our convertible senior notes. Interest expense and additional dilutive shares related to the notes are added back to the calculation when their impact is dilutive. In periods when the impact is anti-dilutive, there is no add-back of interest expense or additional dilutive shares related to the notes. Vertex, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP Financial Measures (continued)
(Unaudited) Three months ended March 31, (Dollars in thousands) 2026 2025 Adjusted EBITDA: Net income (loss) $(2,510) $11,130 Interest income, net (957) (1,539) Income tax benefit (7,139) (5,105) Depreciation and amortization – property and equipment 6,442 5,880 Depreciation and amortization of capitalized software and acquired intangible assets – cost of subscription revenues 20,086 15,855 Amortization of acquired intangible assets – selling and marketing expense 525 531 Amortization of cloud computing implementation costs – general and administrative expense 1,037 1,006 Stock-based compensation expense 18,508 21,044 Severance expense(1) 7,408 457 Change in fair value of acquisition contingent earn-outs (5,738) (14,700) Acquisition-related retained employee compensation(2) 417 — Transaction costs(3) 5,984 2,660 Adjusted EBITDA $44,063 $37,219 Adjusted EBITDA Margin: Total revenues $196,646 $177,062 Adjusted EBITDA margin 22.4 % 21.0 %(1) The three months ended March 31, 2026 includes $6,170 in severance costs related to the Value Creation Plan.(2) The three months ended March 31, 2026 includes compensation expense recognized related to the Additional Cash Consideration obligation associated with the acquisition of Brinta.(3) The three months ended March 31, 2026 and 2025 include legal expenses associated with pending litigation related to claims the Company has made against a competitor. The three months ended March 31, 2026 also includes $2,550 in costs incurred to support the execution of our Value Creation Plan. Three months ended March 31, (Dollars in thousands) 2026 2025 Free Cash Flow: Cash provided by operating activities $37,975 $14,805 Property and equipment additions (24,660) (21,394) Capitalized software additions (5,656) (5,661) Free cash flow $7,659 $(12,250) Free Cash Flow Margin: Total revenues $196,646 $177,062 Free cash flow margin 3.9 % (6.9)% Investor Relations Contact:
Joe Crivelli
Vertex, Inc. [email protected]
Vertex (VERX - Free Report) came out with quarterly earnings of $0.17 per share, beating the Zacks Consensus Estimate of $0.16 per share. This compares to earnings of $0.15 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +5.13%. A quarter ago, it was expected that this company would post earnings of $0.17 per share when it actually produced earnings of $0.17, delivering no surprise.
Over the last four quarters, the company has surpassed consensus EPS estimates two times.
Vertex, which belongs to the Zacks Internet - Software industry, posted revenues of $196.65 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 1.04%. This compares to year-ago revenues of $177.06 million. The company has topped consensus revenue estimates four times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Vertex shares have lost about 36.6% since the beginning of the year versus the S&P 500's gain of 7.6%.
What's Next for Vertex?While Vertex has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Vertex was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.17 on $203.13 million in revenues for the coming quarter and $0.73 on $826.8 million in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Internet - Software is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Ceva (CEVA - Free Report) , another stock in the same industry, has yet to report results for the quarter ended March 2026. The results are expected to be released on May 11.
This chip designer is expected to post quarterly earnings of $0.02 per share in its upcoming report, which represents a year-over-year change of -66.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Ceva's revenues are expected to be $26.23 million, up 8.2% from the year-ago quarter.
Vertex (VERX - Free Report) reported $196.65 million in revenue for the quarter ended March 2026, representing a year-over-year increase of 11.1%. EPS of $0.17 for the same period compares to $0.15 a year ago.
The reported revenue compares to the Zacks Consensus Estimate of $194.62 million, representing a surprise of +1.04%. The company delivered an EPS surprise of +5.13%, with the consensus EPS estimate being $0.16.
While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health.
Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance.
Here is how Vertex performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:
Annual Recurring Revenue: $687.6 million versus $676.42 million estimated by four analysts on average.Net Revenue Retention Rate: 105% compared to the 104.4% average estimate based on two analysts.Revenues- Services: $29.5 million versus $27.87 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a +12.2% change.Revenues- Software subscriptions: $167.15 million versus $166.7 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a +10.9% change.View all Key Company Metrics for Vertex here>>>
Shares of Vertex have returned +9.1% over the past month versus the Zacks S&P 500 composite's +11.4% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term.
Vertex remains a "Buy" as its tax compliance software business shows resilience amid broad SaaS sector weakness. Despite a ~20% YTD and 60% 1-year decline, VERX delivered a strong Q1 beat-and-raise, with accelerating growth and expanding margins. Fears of AI disruption are overblown for VERX, given the complexity and criticality of tax compliance, reinforcing its competitive moat.
CocaCola (NYSE:KO) EVP Jennifer Mann Sells 23,984 SharesMarketBeat
CocaCola Company (The) (NYSE:KO - Get Free Report) EVP Jennifer Mann sold 23,984 shares of the firm's stock in a transaction dated Wednesday, June 10th. The stock was sold at an average price of $83.41, for a total value of $2,000,505.44. Following the completion of the transaction, the executive vice president owned 157,400 shares of the company's stock, valued at approximately $13,128,734. The trade was a 13.22% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is available at the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.
NYSE:KO
Read CocaCola (NYSE:KO) EVP Jennifer Mann Sells 23,984 Shares
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Dutch Bros (NYSE:BROS) Major Shareholder Sells $15,759,829.98 in StockMarketBeat
Dutch Bros Inc. (NYSE:BROS - Get Free Report) major shareholder Dm Individual Aggregator, Llc sold 261,054 shares of the company's stock in a transaction dated Wednesday, June 10th. The stock was sold at an average price of $60.37, for a total transaction of $15,759,829.98. Following the completion of the sale, the insider owned 2,671,855 shares in the company, valued at $161,299,886.35. This represents a 8.90% decrease in their position. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Large shareholders that own at least 10% of a company's shares are required to disclose their transactions with the SEC.
NYSE:BROS
Read Dutch Bros (NYSE:BROS) Major Shareholder Sells $15,759,829.98 in Stock
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Insider Selling: Dutch Bros (NYSE:BROS) Major Shareholder Sells 261,055 Shares of StockMarketBeat
Dutch Bros Inc. (NYSE:BROS - Get Free Report) major shareholder Dm Individual Aggregator, Llc sold 261,055 shares of the business's stock in a transaction dated Thursday, June 11th. The stock was sold at an average price of $63.02, for a total value of $16,451,686.10. Following the completion of the transaction, the insider owned 2,410,800 shares in the company, valued at approximately $151,928,616. This trade represents a 9.77% decrease in their position. The transaction was disclosed in a filing with the SEC, which is available at this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Large shareholders that own at least 10% of a company's shares are required to disclose their transactions with the SEC.
NYSE:BROS
Read Insider Selling: Dutch Bros (NYSE:BROS) Major Shareholder Sells 261,055 Shares of Stock
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Travis Boersma Sells 749,999 Shares of Dutch Bros (NYSE:BROS) StockMarketBeat
Dutch Bros Inc. (NYSE:BROS - Get Free Report) Chairman Travis Boersma sold 749,999 shares of Dutch Bros stock in a transaction that occurred on Wednesday, June 10th. The stock was sold at an average price of $60.39, for a total transaction of $45,292,439.61. Following the completion of the sale, the chairman owned 2,671,855 shares of the company's stock, valued at $161,353,323.45. This represents a 21.92% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.
Dutch Bros Inc. (NYSE:BROS - Get Free Report) Chairman Travis Boersma sold 750,000 shares of the company's stock in a transaction that occurred on Thursday, June 11th. The shares were sold at an average price of $63.02, for a total value of $47,265,000.00. Following the sale, the chairman owned 2,410,800 shares in the company, valued at approximately $151,928,616. This trade represents a 23.73% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is available at this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.
KING OF PRUSSIA, Pa., May 19, 2026 (GLOBE NEWSWIRE) -- Vertex Inc. (NASDAQ: VERX) (“Vertex” or the “Company”), a leading provider of enterprise compliance technology for global commerce, today announced the release of new global research revealing that gaps between IT, Tax, and Finance teams are becoming a growing barrier to compliance. These gaps are exposing organizations to disruption and putting revenue at risk as regulatory demands accelerate.
The 2026 study, How IT, Tax, and Finance Misalignment Is Putting Revenue at Risk, is based on a Vertex commissioned survey of 1,050 senior IT, Finance, and Tax leaders across manufacturing, retail, technology, healthcare, financial services, professional services, legal, and others in the U.S., UK, and Europe. The findings show that despite widespread awareness of the benefits of close collaboration, these key teams often fail to work together effectively. As a result, many businesses are facing challenges around governance, data quality, and ownership at a time when compliance increasingly happens in real time. At the same time, businesses are accelerating ERP modernization, automation, and AI initiatives to manage growing scale and complexity. This could amplify fragmentation if underlying issues remain unresolved.
“These findings are consistent with what we are seeing across the market,” said Kevin Permenter, Research Director, Financial Applications and Agents at IDC. “Many organizations recognize the need for closer alignment between IT, Tax and Finance, but are still early in translating that into consistent operating models. As compliance requirements move closer to real time and organizations accelerate investment in automation and AI, gaps in governance, data quality and ownership are becoming more visible and more impactful on business outcomes.”
Sal Visca, Chief Technology Officer at Vertex also shared: “When tax, IT, and finance teams aren’t aligned from the start, businesses can end up with systems that look fine in concept but struggle in practice, leading to blocked transactions, delayed revenue, and higher risk.”
Key findings from the research include:
Ambition exceeds execution: Only 12% of organizations say they have achieved full, end-to-end tax technology integration, even though 94% expect stronger collaboration across IT, Tax, and Finance.AI adoption is outpacing governance: Meanwhile, 26% of businesses are already using AI-assisted integration monitoring, often before governance models are fully in place.Poor collaboration hurts ROI: Nearly a third (31%) link poor collaboration to data issues, wasted investment, or weak returns on tax technology initiatives.Tax is underrepresented: Tax teams are consulted on tax technology decisions just 37% of the time, compared with 52% for IT and 49% for Finance.Data confidence is low: Confidence in tax-ready data remains fragile, with only 37% reporting high confidence in the quality of their master data.
Regional insights highlight differing levels of exposure:
U.S.: 77% of organizations report high concern, driven by rising transaction volumes (82%), data complexity (80%), and the pace of digital transformation (79%).UK: 75% of businesses report concern, with misalignment already having an impact as 26% report wasted spend and 29% cite fragmented systems.DACH: This region has reported the most structural challenge, with a 35-point gap between IT and Tax involvement and clear cost impacts, including 38% citing wasted spend and 38% fragmented systems.
“As governments roll out e-invoicing mandates and real-time reporting rules, compliance is becoming a gatekeeper for transactions, not a box to tick after the fact,” said Visca. “At the same time, organizations are accelerating ERP upgrades, automation, and AI to manage scale and complexity. If IT, Tax and Finance are not aligned on ownership and decision-making, it will lead to magnified risk, allowing errors to move further and faster through the business.”
The report makes clear that technology alone is not the answer. Organizations that manage tax compliance most effectively bring IT, Tax, and Finance together early, set clear roles and decision rights, align on shared measures of success, and keep governance up to date as regulations and systems evolve.
The full report is available to download here.
About the Study
The research was commissioned by Vertex and fielded by Censuswide in January 2026. The survey reached 1,050 senior IT, Tax, and Finance decision-makers at organizations with annual revenues ranging from $100 million to over $1 billion across the U.S., U.K., France, DACH (Germany, Austria, and Switzerland), Nordics (Denmark, Norway, Sweden, Finland), and Benelux (Belgium and the Netherlands). The study examined how organizations collaborate on indirect tax compliance, tax technology implementation, and governance in the face of evolving regulatory requirements.
About Vertex
Vertex, Inc. is a leading provider of tax and compliance technology for global commerce, combining deep domain expertise with advanced technologies and responsible AI to help businesses transact, comply, and grow with confidence. Powered by AI-driven tax automation, Vertex enables global enterprises to manage complex tax workflows with greater speed, accuracy, and agility. Headquartered in North America, and with offices in South America and Europe, Vertex empowers the world’s leading brands to simplify the complexity of continuous compliance.
For more information, visit www.vertexinc.com or follow us on X and LinkedIn; or subscribe on YouTube.
KING OF PRUSSIA, Pa., June 01, 2026 (GLOBE NEWSWIRE) -- Vertex, Inc. (NASDAQ:VERX), a leading provider of enterprise compliance technology for global commerce, today announced that Chris Young, President and Chief Executive Officer, and John Schwab, Chief Financial Officer, will present at the 46th Annual William Blair Growth Stock Conference on Wednesday, June 3, 2026 at 2:40 PM Central Time.
A live webcast and replay of the presentation will be available on Vertex’s investor relations website at ir.vertex.com.
About Vertex
Vertex, Inc. is a leading provider of tax and compliance technology for global commerce, combining deep domain expertise with advanced technologies and responsible AI to help businesses transact, comply, and grow with confidence. Powered by AI-driven tax automation, Vertex enables global enterprises to manage complex tax workflows with greater speed, accuracy, and agility. Headquartered in North America, and with offices in South America and Europe, Vertex empowers the world’s leading brands to simplify the complexity of continuous compliance.
For more information, visit www.vertexinc.com or follow us on X and LinkedIn; or subscribe on YouTube.
Investor Relations contact:
Joe Crivelli
Vertex, Inc. [email protected]
VRTX stock falls 7.9% in three months as Journavx and Casgevy sales missed expectations, but CF growth, Alyftrek momentum and renal pipeline progress stand out.
Key Takeaways Vertex's BLA for povetacicept in adults with IgAN has been accepted by the FDA.The FDA is expected to make a decision on the application for povetacicept by Nov. 30, 2026.If approved, VRTX plans to launch povetacicept as a once-every-four-weeks at-home auto-injector. Vertex Pharmaceuticals (VRTX - Free Report) announced that the FDA has accepted its biologics license application (BLA) seeking approval for its investigational candidate, povetacicept, for treating adults with immunoglobulin A nephropathy (IgAN), a rare progressive kidney disease.
With the FDA accepting the BLA, a decision from the regulatory body is expected on Nov 30, 2026.
If approved, povetacicept, an investigational engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation-inducing ligand) cytokines, will become the first commercialized therapy in Vertex’s emerging nephrology franchise.
The company plans to launch povetacicept in a low-volume (<0.5 mL) subcutaneous auto-injector delivered once every four weeks via at-home administration, upon potential approval.
Year to date, shares of Vertex have lost 3.3% against the industry’s rise of 0.7%.
Image Source: Zacks Investment Research
VRTX’s Recent Development Activities With PovetaciceptBased on positive interim data from the RAINIER phase III study in IgAN, a rolling BLA filing for povetacicept for IgAN was completed in March 2026. Data from the RAINIER study showed that povetacicept led to a rapid, deep and sustained improvement in proteinuria (excess protein in the urine), a direct consequence of IgAN.
Vertex believes povetacicept has pipeline-in-a-product potential for B-cell-mediated diseases. Povetacicept is designed to target two proteins, namely BAFF and APRIL, which are jointly responsible for the cause of multiple serious autoimmune diseases.
Vertex is also conducting a pivotal phase II/III study of povetacicept for a second potential renal indication, primary membranous nephropathy (pMN). Vertex has also initiated a phase II study on povetacicept for treating generalized myasthenia gravis (gMG) in the first half of 2026.
Povetacicept was added to Vertex’s portfolio following the acquisition of Alpine in 2024. Vertex believes povetacicept holds significant commercial opportunities.
Growing Competition in the Targeted SpaceUpon potential approval, povetacicept is likely to face competition from the likes of Calliditas Therapeutics’ Tarpeyo, Novartis’ (NVS - Free Report) Fabhalta and Travere Therapeutics’ (TVTX - Free Report) Filspari.
Novartis’ Fabhalta is approved under the accelerated pathway for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression. The NVS drug is also approved for complement 3 glomerulopathy and paroxysmal nocturnal hemoglobinuria indications.
Both Calliditas’ Tarpeyo and Travere’s Filspari are approved for a similar indication — to slow the decline in kidney function in adults with primary IgAN who are at risk of disease progression.
VRTX’s Zacks RankVertex currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
- ALYFTREK Phase 3 data on children with cystic fibrosis ages 2 to 5 with vanzacaftor/tezacaftor/deutivacaftor-responsive genotypes including F/F and F/MF shows 65% reached sweat chloride levels of <30 mmol/L; Vertex on track to initiate global regulatory submissions in first half of 2026 -
- Long-term 96-week interim analyses from two open-label extension studies demonstrate positive safety and efficacy profile of ALYFTREK in people with cystic fibrosis ages 6 and older -
- Phase 3 data on TRIKAFTA® in children 1 to <2 years also presented; Vertex has initiated global regulatory submissions -
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data demonstrating the potentially transformative impact of treating cystic fibrosis (CF) with ALYFTREK ® (vanzacaftor/tezacaftor/deutivacaftor) in children ages 2 to 5, as well as data from 96-week interim analyses of two open-label extension studies of ALYFTREK in children 6 to 11 years and people 12 years and older demonstrating the long-term safety and efficacy profile of the medicine. The data, presented at the European Cystic Fibrosis Conference, show children ages 2 to 5 with vanzacaftor/tezacaftor/deutivacaftor-responsive genotypes including those who are homozygous for the F508del mutation (F/F) and those who have F508del/minimal function mutations (F/MF) on ALYFTREK had further improvement in CFTR function from a TRIKAFTA ® baseline as measured by sweat chloride (SwCl), with 65% having achieved SwCl <30 mmol/L after treatment with ALYFTREK. Vertex also presented Phase 3 data of children ages 1 to <2 with TRIKAFTA (elexacaftor/tezacaftor/ivacaftor). Vertex plans to submit for global regulatory approvals of ALYFTREK in children ages 2 to 5 in the first half of 2026, and the company has begun global regulatory submissions for TRIKAFTA in children ages 1 to <2.
“The data we’re presenting today bring us to the cusp of our 25-year mission to advance medicines that restore CFTR function to people living with CF,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “They show that ALYFTREK is the first medicine to bring the majority of children ages 2 to 11 to SwCl below 30 mmol/L, which is incredibly exciting because SwCl <30mmol/L is the median value seen in carriers who are known to have normal health and is a key marker of restoration of CFTR function.”
“As someone who has been treating people with CF for more than 20 years and whose center is involved in the ALYFTREK 2 to 5 years clinical program, I have seen firsthand how the medicine can help patients achieve better CFTR function through reduction in sweat chloride and improve other important markers of disease like exocrine pancreatic function,” said Professor Marcus A. Mall, M.D., Professor and Chair of the Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine and Cystic Fibrosis Center at Charité Universitätsmedizin Berlin. “The findings add to the evidence base exploring CFTR modulation in very young children with cystic fibrosis. Taken together with existing data, these results underscore the rationale for studying treatments that aim to restore CFTR function as early as possible in the disease course.”
Data presented in children ages 2-5 treated with ALYFTREK
“A Phase 3 open-label clinical trial of vanzacaftor/tezacaftor/deutivacaftor in children aged 2-5 years with cystic fibrosis” was presented as a late-breaking abstract and oral presentation in the “Late-Breaking Science” session on June 5 from 5:00 p.m. to 6:30 p.m. GMT+1. Data from 67 children who all completed the 24-week, Phase 3, open-label study show that ALYFTREK was generally safe and well tolerated, consistent with the established safety profile. The primary endpoint of the study was safety and tolerability. Treatment with ALYFTREK resulted in a rapid, clinically meaningful improvement in CFTR function with a mean reduction in sweat chloride from a baseline on TRIKAFTA of -9.6 mmol/L (95% CI -12.1 to -7.0) through Week 24, with 92% of children achieving SwCl concentrations of <60 mmol/L (the diagnostic threshold for CF), and 65% of children reaching SwCl values of <30 mmol/L. These improvements in CFTR function surpass those seen in trials with any other CFTR modulator in this age group.
Longer-term data presented on ALYFTREK and TRIKAFTA
Vertex also presented multiple abstracts on clinical and real-world evidence on ALYFTREK and TRIKAFTA as listed below. These abstracts will be published in the Journal of Cystic Fibrosis:
“Long-term safety and efficacy of vanzacaftor/tezacaftor/deutivacaftor in people with cystic fibrosis aged 12 years and older: 96-week interim analysis from an open-label extension study.” (Poster 143) “Long-term safety and efficacy of vanzacaftor/tezacaftor/deutivacaftor in children with cystic fibrosis aged 6 years and older: 96-week interim analysis from an open-label extension study”; also presented as an oral presentation (WS01.3) during the symposium “Clinical and functional impact of highly effective modulators” on June 4 from 3:00–4:30 p.m. GMT+1. “Demographic and clinical characteristics of children with CF aged 2-5 years initiating ELX/TEZ/IVA in LONGITUDE — a UK CF Registry observational study.” (Poster P432) Data presented in children ages 1 to <2 treated with TRIKAFTA
“A Phase 3, 24-Week, Open-Label Study of Elexacaftor/Tezacaftor/Ivacaftor in Children with Cystic Fibrosis 12 to <24 Months of Age” (WS01.2) was featured in an oral presentation as part of the symposium “Clinical and functional impact of highly effective modulators” on June 4 from 3:00–4:30 p.m. GMT+1 and the abstract will be published in the Journal of Cystic Fibrosis:. Results from a 24-week, Phase 3, open-label study of TRIKAFTA in 54 enrolled children aged 12 to <24 months was presented. The primary endpoint was safety and tolerability. TRIKAFTA was generally safe and well tolerated; the safety data are consistent with the established safety profile. Treatment with TRIKAFTA in this age group resulted in rapid, statistically significant and clinically meaningful decrease in SwCl, with a mean reduction of -71.8 mmol/L from a baseline without CFTR modulator treatment through Week 24, with 98.0% of children achieving concentrations <60 mmol/L and 68.6% reaching <30 mmol/L.
The uses of ALYFTREK in children with CF 2 to 5 years old, and TRIKAFTA in children with CF 1 to <2 years old, are investigational.
U.S. IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR ALYFTREK AND TRIKAFTA
WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE
Elevated transaminases have been observed in patients treated with ALYFTREK.
TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Cases of liver failure leading to transplantation and death have been reported in both clinical trials and the postmarketing setting in patients with and without a history of liver disease taking TRIKAFTA, a fixed-dose combination drug containing elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA), the same or similar active ingredients as ALYFTREK. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA.
Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating ALYFTREK or TRIKAFTA, then every month during the first 6 months of treatment, every 3 months for the next 12 months, and at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or liver function test (LFT) elevations at baseline.
Interrupt ALYFTREK or TRIKAFTA for significant elevations in LFTs or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If resolved, resume treatment only if benefit is expected to outweigh risk. Closer monitoring is advised after resuming treatment.
ALYFTREK or TRIKAFTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C). ALYFTREK or TRIKAFTA is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B). ALYFTREK or TRIKAFTA should only be considered when there is a clear medical need and benefit outweighs risk. If ALYFTREK is used, monitor patients closely. If TRIKAFTA is used, use with caution at a reduced dosage and monitor patients closely.
WARNINGS AND PRECAUTIONS
DRUG-INDUCED LIVER INJURY AND LIVER FAILURE
Elevated transaminases have been observed in patients treated with ALYFTREK. TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Liver failure leading to transplantation and death has been reported in patients with and without a history of liver disease taking TRIKAFTA. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA Assess LFTs in all patients prior to initiating ALYFTREK or TRIKAFTA, then every month during the first 6 months of treatment, every 3 months for the next 12 months, and at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or LFT elevations at baseline, or a history of elevated LFTs with drugs containing ELX, TEZ, and/or IVA Interrupt ALYFTREK or TRIKAFTA in the event of signs or symptoms of liver injury, which may include: Significant elevations in LFTs (e.g., ALT or AST >5x the upper limit of normal (ULN) or ALT or AST >3x ULN with bilirubin >2x ULN) Clinical symptoms suggestive of liver injury (e.g., jaundice, right upper quadrant pain, nausea, vomiting, altered mental status, ascites) Consider referral to a hepatologist and follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If resolved, and if benefit is expected to outweigh risk, resume treatment with close monitoring ALYFTREK and TRIKAFTA should not be used in patients with severe hepatic impairment, are not recommended in patients with moderate hepatic impairment, and should only be considered when there is a clear medical need and benefit outweighs risk. If ALYFTREK is used, monitor patients closely. If TRIKAFTA is used, use with caution at a reduced dosage and monitor patients closely HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS
Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported in the postmarketing setting for TRIKAFTA. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue ALYFTREK or TRIKAFTA and institute appropriate therapy. Consider benefits and risks to determine whether to resume treatment PATIENTS WHO DISCONTINUED OR INTERRUPTED ELX-, TEZ-, OR IVA-CONTAINING DRUGS DUE TO ADVERSE REACTIONS
ALYFTREK
There are no available safety data for ALYFTREK in patients who previously discontinued or interrupted treatment with drugs containing ELX, TEZ, or IVA due to adverse reactions. Consider benefits and risks before using ALYFTREK in these patients and if used, closely monitor for adverse reactions INTRACRANIAL HYPERTENSION (IH)
IH has been reported in the postmarketing setting with TRIKAFTA, which contains the same or similar active ingredients as ALYFTREK. Clinical manifestations of IH include headache, blurred vision, diplopia, and potential vision loss; papilledema can be found on fundoscopy. If an unusual headache or visual disturbances occur during treatment, and IH is suspected, interrupt treatment and refer for prompt medical evaluation. Consider benefits and risks to determine whether to resume treatment. Patients should be monitored until IH resolution and for recurrence. Patients with elevated vitamin A levels may be at increased risk NEUROPSYCHIATRIC EVENTS, INCLUDING SUICIDAL THOUGHTS AND BEHAVIORS
Serious neuropsychiatric events, including symptoms of anxiety, depression, suicidal ideation and behavior, and sleep disturbances, have been reported in the postmarketing setting in patients with and without a previous history of neuropsychiatric symptoms taking ALYFTREK or TRIKAFTA. Symptoms may occur within the first 3 months of treatment. Assess patients for baseline neuropsychiatric symptoms and monitor for new or worsening symptoms. Consider the benefits and risks to determine if treatment should be interrupted at symptom occurrence or resumed with symptom improvement DRUG INTERACTIONS
Use With CYP3A Inducers
Following concomitant use of strong or moderate CYP3A inducers with ALYFTREK, exposures of vanzacaftor, TEZ, and deutivacaftor were decreased, which may reduce ALYFTREK effectiveness. Concomitant use with strong or moderate CYP3A inducers is not recommended Exposure to IVA is significantly decreased and exposure to ELX and TEZ are expected to decrease with concomitant use of CYP3A inducers, which may reduce effectiveness of TRIKAFTA. Concomitant use with strong CYP3A inducers is not recommended Use With CYP3A Inhibitors
Exposure to vanzacaftor, TEZ, and deutivacaftor or ELX, TEZ, and IVA are increased when used concomitantly with strong or moderate CYP3A inhibitors. The dose of ALYFTREK or TRIKAFTA should be reduced when used concomitantly with moderate or strong CYP3A inhibitors CATARACTS
Non-congenital lens opacities have been reported in pediatric patients treated with TRIKAFTA, which contains IVA (similar to an active ingredient in ALYFTREK). Baseline and follow-up ophthalmological examinations are recommended in pediatric patients ADVERSE REACTIONS
ALYFTREK
Serious adverse reactions that occurred more frequently with ALYFTREK than with ELX/TEZ/IVA in 2 or more patients (≥0.4%) were influenza (1.5%), increased AST (0.4%), increased GGT (0.4%), depression (0.4%), and syncope (0.4%) The most common adverse reactions occurring in ≥5% of patients and at a frequency higher than ELX/TEZ/IVA by ≥1% were cough, nasopharyngitis, upper respiratory tract infection (URTI), headache, oropharyngeal pain, influenza, fatigue, increased ALT and AST, rash, and sinus congestion TRIKAFTA
Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo included rash (1% vs <1%) and influenza (1% vs 0%) The most common adverse reactions occurring in ≥5% of patients treated with TRIKAFTA and at a rate higher than placebo by ≥1% were headache; URTI; abdominal pain; diarrhea; rash; increased ALT, blood creatine phosphokinase, AST, and blood bilirubin; nasal congestion; rhinorrhea; rhinitis; influenza; sinusitis; and constipation USE IN SPECIFIC POPULATIONS
PEDIATRIC USE
Safety and effectiveness have not been established for ALYFTREK in patients <6 years, nor for TRIKAFTA in patients <2 years. The use in children under these ages is not recommended INDICATIONS
ALYFTREK is indicated for the treatment of patients ≥6 years who have a clinical diagnosis of CF and ≥1 variant in the CFTR gene that is responsive based on clinical and/or in vitro data or results in CFTR protein production.
TRIKAFTA is indicated for the treatment of patients ≥2 years who have a clinical diagnosis of CF and ≥1 variant in the CFTR gene that is responsive based on clinical and/or in vitro data or results in CFTR protein production.
If the patient’s genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of ≥1 indicated variant.
Please see full U.S. Prescribing Information, including Boxed WARNING, for ALYFTREK and TRIKAFTA.
About Cystic Fibrosis
Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 112,000 people, including approximately 97,000 people in the United States, Europe, Australia and Canada. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving.
Learn more about the importance of sweat chloride (SwCl) in cystic fibrosis.
Today Vertex CF medicines are treating over 75,000 people with CF across more than 60 countries on six continents. This represents approximately 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.
Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the statements made by Carmen Bozic, M.D. and Marcus A. Mall, M.D., and statements about company’s expectations to initiate global regulatory submissions for ALYFTREK in children with CF ages 2 to 5 years in the first half of 2026, expectations for the clinical benefits of ALYFTREK and TRIKAFTA, and expectations for the global regulatory submissions for TRIKAFTA in children with CF ages 1 to <2 years. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the company may be unable to make the anticipated regulatory submissions on the expected timeline, or at all, that data from the company's research and development programs may not support registration or further development of its compounds due to safety, efficacy, and other risks, and other risks listed under the heading “Risk Factors” in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company's website at www.vrtx.com. You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
