PRINCETON, N.J., May 05, 2026 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, today reported financial results for the first quarter ending March 31, 2026.
First Quarter 2026 Highlights
First quarter revenues of $391.9 million increased 2.4% on a reported basis and 1.3% on an organic basis compared to the prior year. First quarter GAAP earnings per diluted share of $(0.06), compared to $(0.33) in the prior year. Adjusted earnings per diluted share of $0.54, compared to $0.41 in the prior year.Reaffirming 2026 full year revenue guidance of $1.662 billion to $1.702 billion and updating 2026 adjusted earnings per share guidance from a range of $2.30 to $2.40 to a range of $2.40 to $2.50. As noted in a separate press release issued this morning, Stuart Essig has been appointed as Integra’s next President and Chief Executive Officer and Michael McBreen has been promoted to Chief Commercial Officer. “Our first-quarter results reflected solid product demand and the continued impact of our transformation efforts. We are seeing improving performance across the organization as operational rigor and improved execution take hold,” said Stuart Essig, chairman and chief executive officer.
“During the quarter, we continued to drive improved supply reliability, supporting strong growth in Integra Skin and our return to market with PriMatrix® and Durepair®. We made meaningful progress at our state-of-the-art Braintree manufacturing facility and remain on track to begin production of SurgiMend® by the end of June to support a fourth quarter launch. Building on these efforts, we are focused on maintaining disciplined execution and remain confident in our ability to deliver our full-year commitments to our customers, patients, and shareholders."
First Quarter 2026 Consolidated Performance
Total reported revenues of $391.9 million increased 2.4% on a reported basis and 1.3% on an organic basis compared to the prior year.
The Company reported GAAP gross margin of 55.4%, compared to 50.8% in the first quarter of 2025. Adjusted gross margin was 64.1%, compared to 62.2% in the prior year.
Adjusted EBITDA for the first quarter of 2026 was $76.2 million, or 19.4% of revenue, compared to $63.6 million, or 16.6% of revenue, in the prior year.
The Company reported a GAAP net loss of $(4.6) million, or $(0.06) per diluted share, in the first quarter of 2026, compared to GAAP net loss of $(25.3) million, or $(0.33) per diluted share, in the prior year.
Adjusted net income for the first quarter of 2026 was $41.6 million, or $0.54 per diluted share, compared to $31.7 million, or $0.41 per diluted share, in the prior year.
First Quarter 2026 Segment Performance
The Company is changing its segment names, with Codman Specialty Surgical renamed Specialty Surgery and Tissue Technologies renamed Tissue Reconstruction. Product brand names remain unchanged. The change to segment names has no financial impact.
Specialty Surgery (~70% of Revenues)
Total revenues were $283.1 million, representing reported growth of 0.9% and an organic decline of (0.6)% compared to the first quarter of 2025.
Sales in Neuro increased 1.9% on an organic basis primarily driven by growth in Certas® Plus, CUSA® and Bactiseal®Sales in Instruments declined (7.7%) on an organic basis due to order timingENT sales declined (3.8)% as growth in MicroFrance® ENT instruments was offset by declines in other products Tissue Reconstruction (~30% of Revenues)
Total revenues were $108.8 million, representing reported growth of 6.7% and organic growth of 6.4% compared to the first quarter of 2025. Key drivers for the quarter include:
Mid-single digit growth in wound reconstruction, driven by double-digit growth in Integra Skin, DuraSorb® and the relaunch of PriMatrix®, partially offset by MediHoney®Sales in private label grew 7.1% primarily due to a favorable prior year comparable Balance Sheet, Cash Flow and Capital Allocation
The Company generated cash flow from operations of $9.8 million in the quarter. Net debt at the end of the quarter was $1.6 billion, and the consolidated total leverage ratio was 4.1x.
As of the end of the quarter, the Company had total liquidity of approximately $488 million, including $265.5 million in cash plus short-term investments and the remainder available under its revolving credit facility.
2026 Revenue and Adjusted Earnings Per Share Guidance
For the second quarter 2026, the Company expects reported revenues in the range of $410 million to $425 million, representing reported growth of (1.3%) to 2.3% and organic growth of (1.5%) to 2.1%. The Company expects adjusted EPS in a range of $0.44 to $0.52 per share.
For the full year 2026, the Company is reiterating its revenue guidance range to $1.662 billion to $1.702 billion. The revenue range represents reported growth of 1.6% to 4.1% and organic growth of 0.8% to 3.3%. The Company is updating its expected adjusted EPS to a range of $2.40 to $2.50 per share reflecting the first quarter benefits from the IEEPA tariffs.
The Company’s organic sales growth guidance for the second quarter and the full year excludes acquisitions and divestitures, as well as the effects of foreign currency.
Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 a.m. ET on Thursday, May 5, 2026, to discuss first quarter 2026 financial results and forward-looking financial guidance. The conference call will be hosted by Integra's senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra's management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.
A live webcast will be available on the Investors section of the Company’s website at investor.integralife.com. For those planning to participate on the call, register here to receive dial-in details and an individual pin. While not required, it is recommended to join 10 minutes prior to the event’s start. A webcast replay of the conference call will be available on the Investors section of the company website following the call.
About Integra
Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies are trusted by healthcare professionals to deliver life-saving care. For our latest news and information, visit www.integralife.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements. Some of these forward-looking statements may contain words like “will,” “believe,” “may,” “could,” “would,” “might,” “possible,” “should,” “expect,” “intend,” "forecast," "guidance," “plan,” “anticipate,” "target," or “continue,” the negative of these words, other terms of similar meaning or they may use future dates. Forward-looking statements contained in this news release include, but are not limited to, statements concerning: future business, operational and financial performance and the Company’s expectations and plans with respect to market opportunity, business and operational performance, strategic initiatives, capabilities, resources, manufacturing capabilities, product development, product availability and regulatory approvals, including expectations regarding the Company’s compliance master plan to improve the Company's quality systems. It is important to note that the Company’s goals and expectations are not predictions of actual performance. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such risks and uncertainties include, but are not limited, to the following: increased geopolitical instability and
other macroeconomic factors, including trade barriers and related restrictions (including tariffs and related countermeasures), armed conflict and acts of terrorism, geopolitical tension and instability, supply chain disruptions, and interest rate and foreign currency rate fluctuations, on the Company’s suppliers, vendors and customers and on the Company’s business and financial condition, results of operations and cash flows; the Company's ability to execute its financial, strategic and operating plans effectively; the Company's ability to remediate quality systems violations; difficulties in implementing the Company’s compliance master plan; difficulties or delays in obtaining and maintaining required regulatory approvals, including the costs thereof; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products; the failure of the company’s suppliers, vendors, and other third parties to meet contractual, regulatory and other obligations; the anticipated development of markets the Company sells its products into and the success of the Company’s products in these markets; the Company’s ability to predict accurately the demand for its products and products under development; increasing industry competition; the coverage and reimbursement decisions of third-party payors; trends toward health care cost containment; difficulties in controlling expenses, including costs to procure and manufacture the Company’s products; the ability of the Company to successfully manage leadership and organizational changes and the impact of changes in management or staff levels; the impact of goodwill and intangible asset impairment charges if future operating results of acquired businesses are significantly less than the results anticipated at the time of the acquisitions, the geographic distribution of where the Company generates its taxable income; changes to applicable laws, regulations and enforcement guidance, including tax laws and global health care reforms; fluctuations in foreign currency exchange rates; the amount of our bank borrowings outstanding and other factors influencing liquidity; breaches, failures or other disruptions of our or our vendors’ or customers’ information technology systems or products; and the economic, competitive, governmental, technological, and other risk factors and uncertainties identified under the heading “Risk Factors” included in Item 1A of Integra's Annual Report on Form 10-K for the year ended December 31, 2025 and information contained in subsequent filings with the Securities and Exchange Commission.
These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise, except as otherwise required by law.
Discussion of Adjusted Financial Measures
In addition to our GAAP results, we provide certain non-GAAP measures, including organic revenues, adjusted earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted net income, adjusted gross margin, adjusted earnings per diluted share, and net debt. Organic revenues consist of total revenues excluding the effects of currency exchange rates, revenues from current-period acquisitions and product divestitures. Adjusted EBITDA consists of GAAP net income excluding: (i) depreciation and amortization; (ii) other income (expense); (iii) interest income and expense; (iv) income tax expense (benefit); (v) impairment charges; and (vi) those operating expenses also excluded from adjusted net income. The measure of adjusted net income consists of GAAP net income, excluding: (i) structural optimization charges; (ii) divestiture, acquisition and integration-related charges; (iii) EU Medical Device Regulation-related charges; (iv) charges related to the manufacturing stoppage and voluntary global recall of all products manufactured at the Company’s Boston, Massachusetts facility and distributed between March 1, 2018 and May 22, 2023, as previously disclosed in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 23, 2023 (the “recall”) and the transition of Boston-related manufacturing operations to the Company’s Braintree, Massachusetts facility; (v) intangible asset amortization expense; (vi) income tax impact from adjustments; and (vii) impairment charges. The measure of adjusted gross margin is calculated by dividing adjusted gross profit by total revenues. Adjusted gross profit consists of GAAP gross profit adjusted for: (i) structural optimization charges; (ii) divestiture, acquisition and integration-related charges; (iii) charges related to the recall and the transition of Boston-related manufacturing operations to the Company’s Braintree, Massachusetts facility; (iv) EU Medical Device Regulation-related charges; and (v) intangible asset amortization expense. The adjusted earnings per diluted share measure is calculated by dividing adjusted net income attributable to diluted shares by diluted weighted average shares outstanding. The measure of net debt consists of GAAP total debt (excluding deferred financing costs) less short-term investments, cash and cash equivalents.
Reconciliations of GAAP revenues to organic revenues, GAAP net income to adjusted EBITDA, and adjusted net income, GAAP gross margin to adjusted gross margin, GAAP total debt to net debt, and GAAP earnings per diluted share to adjusted earnings per diluted share all for the quarters ended March 31, 2026 and 2025.
The Company is providing forward-looking guidance regarding organic revenue and adjusted earnings per diluted share but is not providing reconciliations to the most directly comparable forward-looking GAAP financial measures because certain GAAP expense items and the impact of changes in foreign exchange rates are highly variable and management is unable to predict them with reasonable certainty and without unreasonable effort. Specifically, the actual impact of changes in foreign exchange rates and the financial impact and timing of divestitures, acquisitions, integrations, structural optimization, efforts to comply with the EU Medical Device Regulation, and income tax impact from adjustments are uncertain, depend on various dynamic factors and are not reasonably ascertainable at this time. The unavailable information could have a material impact on GAAP results.
The Company believes that the presentation of organic revenues and the other non-GAAP measures provide important supplemental information to management and investors regarding financial and business trends relating to the Company's financial condition and results of operations. For further information regarding why Integra believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company's Current Report on Form 8-K regarding this earnings press release filed today with the Securities and Exchange Commission. This Current Report on Form 8-K is available on the SEC's website at www.sec.gov or on our website at www.integralife.com.
Investor Relations Contact:
Chris Ward
(609) 772-7736 [email protected]
INTEGRA LIFESCIENCES HOLDINGS CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended March 31, 2026 2025 Total revenue, net$391,918 $382,653 Costs and expenses: Cost of goods sold 174,936 188,221 Research and development 23,501 24,728 Selling, general and administrative 178,235 181,497 Intangible asset amortization 3,776 3,704 Total costs and expenses 380,448 398,150 Operating income (loss) 11,470 (15,497)Interest income 4,106 4,420 Interest expense (22,465) (18,815)Other income (expense), net 4,480 (144)Loss before income taxes (2,409) (30,036)Provision for income taxes 2,208 (4,743)Net loss$(4,617) $(25,293) Net loss per share Diluted$(0.06) $(0.33) Weighted average common shares outstanding 76,951 76,463 The following table presents revenues disaggregated by the major sources for the three months ended March 31, 2026 and 2025 (amounts in thousands):
Three Months Ended March 31, 2026 2025ChangeNeurosurgery$198,195 $190,9123.8%Instruments 47,233 50,950(7.3)%ENT 37,707 38,802(2.8)%Total Codman Specialty Surgical 283,135 280,6640.9% Wound Reconstruction and Care 79,648 74,7796.5%Private Label 29,135 27,2107.1%Total Tissue Technologies 108,783 101,9896.7%Total reported revenues$391,918 $382,6532.4% Impact of changes in currency exchange rates (4,452) — Total organic revenues(1)$387,467 $382,6531.3% (1) Organic revenues have been adjusted to exclude foreign currency (current period), acquisitions and to account for divested and discontinued products. Items included in GAAP net income and location where each item is recorded are as follows:
(In thousands)Three Months Ended March 31, 2026 ItemTotal AmountCOGS(a)SG&A(b)R&D(c)Amort (d)OI&E(e)Tax(f)Acquisition, divestiture and integration-related charges
9,286 2,5886,120578——— EU Medical Device Regulation charges7,887
1,153
3,338
3,397
—
—
—
Boston Recall/Braintree Transition7,728
7,135
575
19
—
—
—
Intangible asset amortization expense27,005
23,230
—
—
3,775
—
—
Estimated income tax impact from above adjustments and other items
(7,541
)
—
—
—
—
—
(7,541
)
Depreciation expense11,235
—
—
—
—
—
—
a) COGS - Cost of goods sold
b) SG&A - Selling, general and administrative
c) R&D - Research & development
d) Amort. - Intangible asset amortization
e) OI&E - Other income & expense
f) Tax - Income tax expense (benefit) Items included in GAAP net income and location where each item is recorded are as follows:
(In thousands) Three Months Ended March 31, 2025 ItemTotal AmountCOGS(a)SG&A(b)R&D(c)Amort (d)OI&E(e)Tax(f)Acquisition, divestiture and integration-related charges
26,473 22,769—— 3,704—— Estimated income tax impact from above adjustments and other items
(12,167)——— ——(12,167)Depreciation expense
10,456 ——— ——— a) COGS - Cost of goods sold
b) SG&A - Selling, general and administrative
c) R&D - Research & development
d) Amort. - Intangible asset amortization
e) OI&E - Other income & expense
f) Tax - Income tax expense (benefit) RECONCILIATION OF NON-GAAP ADJUSTMENTS - GAAP NET INCOME TO ADJUSTED EBITDA
(UNAUDITED)
(In thousands)
Three Months Ended March 31, 2026 2025 GAAP net loss$(4,617) $(25,293)Non-GAAP adjustments: Depreciation and intangible asset amortization expense 38,240 36,929 Other (income) expense, net (4,480) (320)Interest expense, net 18,118 14,394 Income tax expense 2,208 (4,743)Structural optimization charges 9,286 10,663 EU Medical Device Regulation charges 7,887 10,944 Boston Recall/Braintree Transition 7,728 14,810 Acquisition, divestiture and integration-related charges 1,812 6,224 Total of non-GAAP adjustments 80,799 88,902 Adjusted EBITDA$76,182 $63,609 RECONCILIATION OF NON-GAAP ADJUSTMENTS - GAAP NET INCOME TO MEASURES OF ADJUSTED NET INCOME AND ADJUSTED EARNINGS PER SHARE
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended March 31, 2026 2025 GAAP net loss$(4,617) $(25,293)Non-GAAP adjustments: Structural optimization charges 9,286 10,663 Acquisition, divestiture and integration-related charges 1,812 6,224 EU Medical Device Regulation charges 7,887 10,944 Boston Recall/Braintree Transition 7,728 14,810 Intangible asset amortization expense 27,005 26,473 Estimated income tax impact from adjustments and other items (7,541) (12,167)Total of non-GAAP adjustments 46,177 56,947 Adjusted net income$41,560 $31,654 Adjusted diluted net income per share$0.54 $0.41 Weighted average common shares outstanding for diluted net income per share 77,198 76,586 CONDENSED BALANCE SHEET DATA
(UNAUDITED) (In thousands)
March 31,
2026 December 31,
2025 Short term investments$28,693 $28,693Cash and cash equivalents 236,809 235,048Trade accounts receivable, net 264,413 278,849Inventories, net 495,035 492,735 Current and long-term borrowing under senior credit facility 1,789,005 1,768,306Borrowings under securitization facility 76,400 87,800Convertible securities — — Stockholders' equity$1,042,406 $1,043,463 CONDENSED STATEMENT OF CASH FLOWS
(UNAUDITED) (In thousands)
Three Months Ended March 31, 2026 2025 Net cash (used) provided by operating activities$9,803 $(11,257)Net cash used in investing activities (14,848) (35,920)Net cash provided by financing activities 8,297 35,377 Effect of exchange rate changes on cash and cash equivalents (1,491) 4,529 Net decrease in cash and cash equivalents$1,761 $(7,271) RECONCILIATION OF NON-GAAP ADJUSTMENTS - GAAP OPERATING CASH FLOW TO
MEASURES OF FREE CASH FLOW AND ADJUSTED FREE CASH FLOW CONVERSION
(UNAUDITED)
(In thousands) Three Months Ended March 31, 2026 2025 Net cash provided by operating activities$9,803 $(11,257) Purchases of property and equipment (14,848) (28,920)Free cash flow$(5,045)$(40,177) Adjusted net income(1)$41,560 $31,654 Adjusted free cash flow conversion (12.1)% (126.9)% Twelve Months Ended March 31, 2026 2025 Net cash provided by operating activities$71,445 $102,368 Purchases of property and equipment (67,365) (117,872)Free cash flow$4,080 $(15,504) Adjusted net income(1)$181,287 $185,652 Adjusted free cash flow conversion 2.3% (8.4)% (1) Adjusted net income for quarters ended March 31, 2026 and 2025 are reconciled above. Adjusted net income for remaining quarters in the trailing twelve months calculation have been previously reconciled and are publicly available in the Quarterly Earnings Call Presentations on our website at investor.integralife.com under Events & Presentations. The Company calculates adjusted free cash flow conversion by dividing its free cash flow by adjusted net income. The Company believes this measure is useful in evaluating the significance of the cash special charges in its adjusted earnings measures.
RECONCILIATION OF NON-GAAP ADJUSTMENTS - NET DEBT CALCULATION
(UNAUDITED) (In thousands) March 31,
2026December 31,
2025Short-term borrowings under senior credit facility$38,750 $38,750 Long-term borrowings under senior credit facility 1,750,255 1,729,556 Borrowings under securitization facility 76,400 87,800 Convertible securities — — Deferred financing costs netted in the above 2,870 3,257 Short term investments (28,693) (28,693)Cash & Cash Equivalents (236,809) (235,048)Net Debt$1,602,773 $1,595,622 RECONCILIATION OF NON-GAAP ADJUSTMENTS - GAAP GROSS PROFIT TO MEASURES OF ADJUSTED GROSS PROFIT AND ADJUSTED GROSS MARGIN
(UNAUDITED)
(In thousands, except percentages)
Three Months Ended March 31, 2026 2025 Total revenues, net$391,918 $382,653 Cost of goods sold 174,936 188,221 Reported Gross Profit 216,982 194,432 Structural optimization charges 2,588 4,276 Acquisition, divestiture and integration-related charges 28 671 Boston Recall/Braintree Transition 7,135 14,386 EU Medical Device Regulation 1,153 1,375 Intangible asset amortization expense 23,230 22,769 Adjusted Gross Profit$251,116 $237,909 Total Revenues$391,918 $382,653 Adjusted Gross Margin 64.1% 62.2%
Integra LifeSciences (IART - Free Report) came out with quarterly earnings of $0.54 per share, beating the Zacks Consensus Estimate of $0.41 per share. This compares to earnings of $0.41 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +32.78%. A quarter ago, it was expected that this medical device maker would post earnings of $0.79 per share when it actually produced earnings of $0.83, delivering a surprise of +5.06%.
Over the last four quarters, the company has surpassed consensus EPS estimates four times.
Integra, which belongs to the Zacks Medical - Instruments industry, posted revenues of $391.92 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 2.74%. This compares to year-ago revenues of $382.65 million. The company has topped consensus revenue estimates three 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.
Integra shares have lost about 14.3% since the beginning of the year versus the S&P 500's gain of 5.2%.
What's Next for Integra?While Integra 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 Integra 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 $0.54 on $424.24 million in revenues for the coming quarter and $2.34 on $1.67 billion 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, Medical - Instruments is currently in the bottom 42% 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.
Another stock from the same industry, Stereotaxis Inc. (STXS - Free Report) , has yet to report results for the quarter ended March 2026. The results are expected to be released on May 12.
This company is expected to post quarterly loss of $0.05 per share in its upcoming report, which represents a year-over-year change of +28.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Stereotaxis Inc.'s revenues are expected to be $9.1 million, up 21.8% from the year-ago quarter.
For the quarter ended March 2026, Integra LifeSciences (IART - Free Report) reported revenue of $391.92 million, up 2.4% over the same period last year. EPS came in at $0.54, compared to $0.41 in the year-ago quarter.
The reported revenue compares to the Zacks Consensus Estimate of $381.46 million, representing a surprise of +2.74%. The company delivered an EPS surprise of +32.78%, with the consensus EPS estimate being $0.41.
While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance.
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 Integra performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:
Organic Revenue Growth: 1.3% versus -1.9% estimated by two analysts on average.Revenue- Tissue Technologies- Wound Reconstruction and Care: $79.65 million versus $70.98 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +6.5% change.Revenue- Tissue Technologies- Total: $108.78 million versus the two-analyst average estimate of $99.48 million. The reported number represents a year-over-year change of +6.7%.Revenue- Codman Specialty Surgical- Total: $283.14 million versus $281.62 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +0.9% change.Revenue- Tissue Technologies- Private Label: $29.14 million compared to the $28 million average estimate based on two analysts. The reported number represents a change of +7.1% year over year.View all Key Company Metrics for Integra here>>>
Shares of Integra have returned +14.4% over the past month versus the Zacks S&P 500 composite's +9.5% 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.
Integra LifeSciences (IART - Free Report) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.
A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.
Since a changing earnings picture is a powerful factor influencing near-term stock price movements, the Zacks rating system is very useful for individual investors. They may find it difficult to make decisions based on rating upgrades by Wall Street analysts, as these are mostly driven by subjective factors that are hard to see and measure in real time.
As such, the Zacks rating upgrade for Integra is essentially a positive comment on its earnings outlook that could have a favorable impact on its stock price.
Most Powerful Force Impacting Stock PricesThe change in a company's future earnings potential, as reflected in earnings estimate revisions, and the near-term price movement of its stock are proven to be strongly correlated. The influence of institutional investors has a partial contribution to this relationship, as these big professionals use earnings and earnings estimates to calculate the fair value of a company's shares. An increase or decrease in earnings estimates in their valuation models simply results in higher or lower fair value for a stock, and institutional investors typically buy or sell it. Their bulk investment action then leads to price movement for the stock.
For Integra, rising earnings estimates and the consequent rating upgrade fundamentally mean an improvement in the company's underlying business. And investors' appreciation of this improving business trend should push the stock higher.
Harnessing the Power of Earnings Estimate RevisionsAs empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock movements, tracking such revisions for making an investment decision could be truly rewarding. Here is where the tried-and-tested Zacks Rank stock-rating system plays an important role, as it effectively harnesses the power of earnings estimate revisions.
The Zacks Rank stock-rating system, which uses four factors related to earnings estimates to classify stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record, with Zacks Rank #1 stocks generating an average annual return of +25% since 1988. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here >>>> .
Earnings Estimate Revisions for IntegraFor the fiscal year ending December 2026, this medical device maker is expected to earn $2.38 per share, which is unchanged compared with the year-ago reported number.
Analysts have been steadily raising their estimates for Integra. Over the past three months, the Zacks Consensus Estimate for the company has increased 6.2%.
Bottom LineUnlike the overly optimistic Wall Street analysts whose rating systems tend to be weighted toward favorable recommendations, the Zacks rating system maintains an equal proportion of "buy" and "sell" ratings for its entire universe of more than 4,000 stocks at any point in time. Irrespective of market conditions, only the top 5% of the Zacks-covered stocks get a "Strong Buy" rating and the next 15% get a "Buy" rating. So, the placement of a stock in the top 20% of the Zacks-covered stocks indicates its superior earnings estimate revision feature, making it a solid candidate for producing market-beating returns in the near term.
You can learn more about the Zacks Rank here >>>
The upgrade of Integra to a Zacks Rank #2 positions it in the top 20% of the Zacks-covered stocks in terms of estimate revisions, implying that the stock might move higher in the near term.
PRINCETON, N.J., May 08, 2026 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, today announced that chief financial officer Lea Knight will present at the BofA Securities 2026 Health Care Conference on May 12, 2026 at 4:20pm PT.
A live webcast of the presentation will be available on the Integra LifeSciences investor relations website under EVENTS & PRESENTATIONS.
About Integra LifeSciences
Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies are trusted by healthcare professionals to deliver life-saving care. For our latest news and information, visit www.integralife.com.
3 Undervalued Midcaps Ready to PopIntegra LifeSciences NASDAQ: IART is keeping its core strategy intact following a leadership change that returned Stuart to the roles of chairman and chief executive officer, Chief Financial Officer Lea Knight said during a Bank of America med tech conference discussion hosted by analyst Rei Tan.
Knight said the company’s board and former CEO Mojdeh Poul reached a mutual decision for Poul to step down. She said Stuart has backed the operational transformation work already underway, including efforts to strengthen operational capabilities and quality management systems.
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“Those are initiatives led by Mojdeh Poul, but they had the approval of the Board, and Stuart has also given it his full force and backing,” Knight said.
She added that the company’s focus areas — neurosurgery, tissue reconstruction and ENT — will remain unchanged. Knight said those markets represent a total addressable market of about $9 billion, with Integra operating in niche categories where it is generally ranked first or second.
Integra Points to Lower Volatility After Q1 Results Knight said Integra’s first-quarter results offered an early proof point that its transformation efforts are gaining traction. The company reported revenue and earnings per share above the high end of its guidance, which Knight said reflected operational improvements.
She said internal indicators supporting management’s confidence include fewer and less severe supply disruptions, better visibility from a supply chain “control tower,” improved yields and stronger external regulatory audit results. Cash flow also improved meaningfully in the first quarter, she said.
“As we measure all of these indicators, what we’re seeing, in fact, is it is helping to lower the volatility, which is going to be the key to allow us to perform more consistently from a growth perspective,” Knight said.
Knight reiterated that the company views its recent challenges as supply-related rather than demand-related. She said Integra does not expect to expand its commercial sales force in the near term, instead focusing on consistent product supply, returning products to market and using analytical tools to improve commercial execution.
Braintree Facility and SurgiMend Relaunch in Focus Discussing manufacturing, Knight said issues at Integra’s Boston facility stemmed from “an accumulation of gaps” in the quality management system that were compounded by the physical limitations of the site. By contrast, she described the Braintree facility as a “world-class tissue manufacturing facility” designed to improve process flow and efficiency.
Knight said Integra has revamped its quality management system, reduced manual processes, validated manufacturing protocols and added new leadership at the site. The company remains on track to operationalize Braintree in June, build inventory in the third quarter and support a fourth-quarter launch of SurgiMend back into the market.
She said the market for surgical matrices in breast reconstruction is about $800 million and growing at double-digit rates. Knight also said market trends have become more favorable for Integra, including a shift away from human ADM toward xenografts and resorbable synthetics, areas aligned with SurgiMend and DuraSorb.
Integra expects to pursue PMA labels for SurgiMend and DuraSorb in implant-based breast reconstruction, with Knight saying the company expects those in 2027. She said the relaunch strategy will be “phased and disciplined,” beginning with key prior users.
PriMatrix Relaunch and Reimbursement Dynamics Knight said Integra is pleased with the relaunch of PriMatrix, which returned to the market in the fourth quarter of 2025 after being off the market for more than two years. She said the initial launch was controlled, with broader expansion in the first quarter, and performance has been consistent with expectations.
Some prior users have returned, while others want Integra to continue demonstrating reliable supply, Knight said. She added that the company does not believe it needs to meaningfully change pricing to regain share because of product differentiation and clinical trust.
On wound care reimbursement, Knight said about 90% of Integra’s business is in the inpatient acute setting, where reimbursement under DRGs has not changed. She said wound reconstruction products delivered double-digit growth in the first quarter.
For the approximately 10% of the business in outpatient settings, Knight said Integra has not seen the same disruption as others. She pointed to the company’s product price, size options and clinical evidence, noting that Integra was already priced in line with the current reimbursement rate of $127 per square centimeter.
Growth Outlook, ENT Pressures and Capital Allocation Knight said both tissue reconstruction and specialty surgery are expected to contribute to growth, though tissue reconstruction is expected to grow faster as supply reliability improves and products return to the market. She said SurgiMend should contribute to growth in 2026, with PMA labels for SurgiMend and DuraSorb expected to support further growth in 2027.
In ENT, Knight said Integra continues to face reimbursement-related headwinds in balloon sinuplasty, which affected results in 2025 and are expected to continue into 2026. She said growth opportunities are stronger in navigation systems and Eustachian tube products, which could eventually help return ENT to a mid-single-digit to high-single-digit growth trajectory.
On capital allocation, Knight said debt repayment remains the priority. Integra is targeting a leverage range of 2.5 times to 3.5 times, and Knight said the company expects to be just outside the upper end of that range by the end of 2026 and within the range in 2027.
Knight said M&A could eventually return to the strategy, but only after operations stabilize and cash flow improves. Potential deals would likely be tuck-in to midsize opportunities in neurosurgery, tissue reconstruction, ENT or adjacent markets.
Tariffs, Cost Savings and Cash Flow Knight said Integra recorded a $0.10 first-quarter EPS benefit relative to guidance from tariffs. That included a $0.03 refund for prior-year tariffs and $0.07 of avoided tariff expense after IEEPA tariffs were ruled unlawful.
For the full year, Integra now expects tariff impacts of about $0.10 to EPS, compared with a prior expectation of $0.32. Knight said the company has not reflected a potential additional $0.12 benefit in guidance because tariff policy remains uncertain.
Integra has identified $25 million to $30 million in cost savings initiatives that Knight said are fully implemented. The savings come from manufacturing efficiencies, yield improvements, operating model changes and lower third-party costs in SG&A.
Knight said the company is targeting operating cash flow of $200 million for the year, an improvement of $150 million, and free cash flow of about $140 million after negative free cash flow in the prior year. She cited improved EBITDA, working capital gains, lower EU MDR and Braintree startup spending, and normalized capital expenditures as drivers.
“It feels good to see evidence that the transformation is working,” Knight said in closing. “We still have a lot of work to do.”
About Integra LifeSciences NASDAQ: IARTIntegra LifeSciences Corporation is a global medical technology company specializing in products and innovations for neurosurgery, regenerative medicine and reconstructive procedures. The company develops and markets surgical instruments, implants and advanced wound care solutions designed to support tissue repair and functional recovery. Its product portfolio includes collagen-based matrices, dural substitutes, hemostatic agents and specialized spinal and peripheral fixation devices.
Founded in 1989 and headquartered in Plainsboro, New Jersey, Integra has expanded its capabilities through targeted acquisitions and internal research efforts.
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Each stock is given an alphabetic rating of A, B, C, D or F based on their value, growth, and momentum qualities. With this system, an A is better than a B, a B is better than a C, and so on, meaning the better the score, the better chance the stock will outperform.
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Value ScoreFinding good stocks at good prices, and discovering which companies are trading under their true value, are what value investors like to focus on. So, the Value Style Score takes into account ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and a host of other multiples to highlight the most attractive and discounted stocks.
Growth ScoreGrowth investors, on the other hand, are more concerned with a company's financial strength and health, and its future outlook. The Growth Style Score examines things like projected and historic earnings, sales, and cash flow to find stocks that will experience sustainable growth over time.
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VGM ScoreIf you like to use all three kinds of investing, then the VGM Score is for you. It's a combination of all Style Scores, and is an important indicator to use with the Zacks Rank. The VGM Score rates each stock on their shared weighted styles, narrowing down the companies with the most attractive value, best growth forecast, and most promising momentum.
How Style Scores Work with the Zacks Rank The Zacks Rank is a proprietary stock-rating model that harnesses the power of earnings estimate revisions, or changes to a company's earnings expectations, to help investors build a successful portfolio.
Investors can count on the Zacks Rank's success, with #1 (Strong Buy) stocks producing an unmatched +23.7% average annual return since 1988, more than double the S&P 500's performance. But the model rates a large number of stocks, and there are over 200 companies with a Strong Buy rank, plus another 600 with a #2 (Buy) rank, on any given day.
But it can feel overwhelming to pick the right stocks for you and your investing goals with over 800 top-rated stocks to choose from.
That's where the Style Scores come in.
To maximize your returns, you want to buy stocks with the highest probability of success. This means picking stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you find yourself looking at stocks with a #3 (Hold) rank, make sure they have Scores of A or B as well to ensure as much upside potential as possible.
The direction of a stock's earnings estimate revisions should always be a key factor when choosing which stocks to buy, since the Scores were created to work together with the Zacks Rank.
Here's an example: a stock with a #4 (Sell) or #5 (Strong Sell) rating, even one with Style Scores of A and B, still has a downward-trending earnings outlook, and a bigger chance its share price will decrease too.
Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.
Stock to Watch: Integra LifeSciences (IART - Free Report) Headquartered in Plainsboro, NJ, Integra LifeSciences is one of the world leaders in regenerative medicine. The company develops, manufactures and markets cost-effective surgical implants and medical instruments. The company now manufactures and sells products in the following two global reportable business segments: Codman Specialty Surgical (CSS) and Tissue Technologies.
IART is a #2 (Buy) on the Zacks Rank, with a VGM Score of A.
Momentum investors should take note of this Medical stock. IART has a Momentum Style Score of B, and shares are up 26.6% over the past four weeks.
Three analysts revised their earnings estimate upwards in the last 60 days for fiscal 2026. The Zacks Consensus Estimate has increased $0.10 to $2.42 per share. IART boasts an average earnings surprise of +16.8%.
With a solid Zacks Rank and top-tier Momentum and VGM Style Scores, IART should be on investors' short list.
Investors looking for stocks in the Medical - Instruments sector might want to consider either Integra LifeSciences (IART) or Masimo (MASI). But which of these two stocks presents investors with the better value opportunity right now?
It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.
The research service features daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, all of which will help you become a smarter, more confident investor.
It also includes access to the Zacks Style Scores.
What are the Zacks Style Scores? Developed alongside the Zacks Rank, the Zacks Style Scores are a group of complementary indicators that help investors pick stocks with the best chances of beating the market over the next 30 days.
Each stock is assigned a rating of A, B, C, D, or F based on their value, growth, and momentum characteristics. Just like in school, an A is better than a B, a B is better than a C, and so on -- that means the better the score, the better chance the stock will outperform.
The Style Scores are broken down into four categories:
Value ScoreFinding good stocks at good prices, and discovering which companies are trading under their true value, are what value investors like to focus on. So, the Value Style Score takes into account ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and a host of other multiples to highlight the most attractive and discounted stocks.
Growth ScoreGrowth investors, on the other hand, are more concerned with a company's financial strength and health, and its future outlook. The Growth Style Score examines things like projected and historic earnings, sales, and cash flow to find stocks that will experience sustainable growth over time.
Momentum ScoreMomentum traders and investors live by the saying "the trend is your friend." This investing style is all about taking advantage of upward or downward trends in a stock's price or earnings outlook. Employing factors like one-week price change and the monthly percentage change in earnings estimates, the Momentum Style Score can indicate favorable times to build a position in high-momentum stocks.
VGM ScoreIf you like to use all three kinds of investing, then the VGM Score is for you. It's a combination of all Style Scores, and is an important indicator to use with the Zacks Rank. The VGM Score rates each stock on their shared weighted styles, narrowing down the companies with the most attractive value, best growth forecast, and most promising momentum.
How Style Scores Work with the Zacks Rank The Zacks Rank is a proprietary stock-rating model that harnesses the power of earnings estimate revisions, or changes to a company's earnings expectations, to help investors build a successful portfolio.
It's highly successful, with #1 (Strong Buy) stocks producing an unmatched +23.7% average annual return since 1988. That's more than double the S&P 500. But because of the large number of stocks we rate, there are over 200 companies with a Strong Buy rank, plus another 600 with a #2 (Buy) rank, on any given day.
But it can feel overwhelming to pick the right stocks for you and your investing goals with over 800 top-rated stocks to choose from.
That's where the Style Scores come in.
To maximize your returns, you want to buy stocks with the highest probability of success. This means picking stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you find yourself looking at stocks with a #3 (Hold) rank, make sure they have Scores of A or B as well to ensure as much upside potential as possible.
As mentioned above, the Scores are designed to work with the Zacks Rank, so any change to a company's earnings outlook should be a deciding factor when picking which stocks to buy.
For instance, a stock with a #4 (Sell) or #5 (Strong Sell) rating, even one that boasts Scores of A and B, still has a downward-trending earnings forecast, and a much greater likelihood its share price will decline as well.
Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.
Stock to Watch: Integra LifeSciences (IART - Free Report) Headquartered in Plainsboro, NJ, Integra LifeSciences Holdings Corporation is one of the world leaders in regenerative medicine. The company develops, manufactures and markets surgical implants and medical instruments. In its first-quarter 2026 report, the company renamed two of its segments: Codman Specialty Surgical was renamed Specialty Surgery, while Tissue Technologies was renamed Tissue Reconstruction.
IART is a #2 (Buy) on the Zacks Rank, with a VGM Score of A.
It also boasts a Value Style Score of B thanks to attractive valuation metrics like a forward P/E ratio of 6.25; value investors should take notice.
Three analysts revised their earnings estimate higher in the last 60 days for fiscal 2026, while the Zacks Consensus Estimate has increased $0.10 to $2.42 per share. IART also boasts an average earnings surprise of +16.8%.
With a solid Zacks Rank and top-tier Value and VGM Style Scores, IART should be on investors' short list.
Key Takeaways DaVita's dialysis business and Integrated Kidney Care momentum support its long-term growth outlook.Integra benefits from stronger Specialty Surgery demand and improved supply execution momentum.LyondellBasell and Braskem pair discounted valuations with solid long-term growth expectations. In the equity market, investors often seek strategies that can balance risk and reward, especially during periods of heightened volatility and economic uncertainty. While some investors favor deeply discounted value stocks and others pursue high-growth opportunities, a blended approach has increasingly proven effective in navigating changing market conditions.
This has led to the growing popularity of the GARP (growth at a reasonable price) strategy, which combines the core principles of value and growth investing. Rather than focusing solely on undervalued stocks or aggressive growth plays, GARP investors look for companies that offer sustainable earnings growth while still trading at attractive valuations. The approach aims to capture long-term upside potential without overpaying for momentum-driven stocks.
The success of this hybrid investing strategy has been evident in several outperforming stocks across sectors in recent years. Companies with strong fundamentals, resilient earnings growth and reasonable valuations have delivered substantial returns, highlighting the effectiveness of balancing value with growth characteristics. Here, we discuss four such stocks: DaVita (DVA - Free Report) , Integra LifeSciences (IART - Free Report) , Braskem (BAK - Free Report) and LyondellBasell Industries (LYB - Free Report) .
A Few More Words on GARPGARP investing gives priority to one of the popular value metrics, the price/earnings growth (PEG) ratio. Although it is categorized under value investing, this strategy follows the principles of both growth and value investing.
The PEG ratio is defined as (Price/ Earnings)/Earnings Growth Rate.
It relates the stocks’ P/E ratios to the future earnings growth rates.
While P/E alone gives an idea of stocks that are trading at a discount, PEG, while adding the growth element to it, helps identify stocks with solid future potential.
A lower PEG ratio, preferably less than 1, is always better for GARP investors.
Say, for example, if a stock's P/E ratio is 10 and the expected long-term growth rate is 15%, the company's PEG will come down to 0.66, a ratio indicating both undervaluation and future growth potential.
Unfortunately, this ratio is often neglected due to investors' limitations in calculating the future earnings growth rate of a stock.
There are some drawbacks to using the PEG ratio, though. It does not consider the very common situation of changing growth rates, such as the forecast of the first three years at a very high growth rate, followed by a sustainable but lower growth rate over the long term.
Hence, PEG-based investing can be even more rewarding if some other relevant parameters are also taken into consideration.
Here are the screening criteria for a winning strategy:
PEG Ratio less than X Industry Median
P/E Ratio (using F1) less than X Industry Median (For more accurate valuation purposes)
Zacks Rank #1 (Strong Buy) or 2 (Buy) (Whether good market conditions or bad, stocks with a Zacks Rank #1 or #2 have a proven history of success.)
Market Capitalization greater than $1 Billion (This helps us to focus on companies that have strong liquidity.)
Average 20-Day Volume greater than 50,000: A substantial trading volume ensures that the stock is easily tradable.
Percentage Change F1 Earnings Estimate Revisions (4 Weeks) greater than 5%: Upward estimate revisions add to the optimism, suggesting further bullishness.
Value Score of less than or equal to B: Our research shows that stocks with a Value Style Score of A or B, when combined with a Zacks Rank #1, 2 or 3 (Hold), offer the best upside potential.
Growth Score of less than or equal to B: Our research shows that stocks with a Growth Style Score of A or B, when combined with a Zacks Rank #1, 2 or 3, offer the best upside potential.
Our PEG-Driven PicksHere are four stocks that qualified for the screening:
DaVita: Headquartered in Denver, CO, DaVita is a leading provider of dialysis services in the United States to patients suffering from chronic kidney failure, also known as end-stage renal disease. Its U.S. dialysis segment remains the primary earnings driver, supported by steady reimbursement and cost control. Management also highlighted continued momentum within the Integrated Kidney Care during first-quarter 2026
DVA can be an impressive GARP investment pick with its Zacks Rank #1, a Value Score of B and a Growth Score of B. Apart from a discounted PEG and P/E, the stock has an impressive long-term expected growth rate of 20.2%.
You can see the complete list of today’s Zacks #1 Rank stocks here.
Integra: Headquartered in Plainsboro, NJ, Integra LifeSciences Holdings Corporation is one of the world leaders in regenerative medicine. The company develops, manufactures and markets surgical implants and medical instruments. Integra is seeing steadier demand in Specialty Surgery, supported by its neurosurgery franchise and a broader ENT platform from Acclarent, while improving supply execution is helping conversion and capital equipment placements.
IART has a Zacks Rank #2, a Value Score of B and a Growth Style Score of B. Integra also has a five-year expected growth rate of 5.9%.
Braskem: Braskem manufactures and sells petrochemicals, thermoplastic resins and fuels in Brazil and international markets. Its portfolio includes polyethylene, polypropylene, PVC and basic chemicals, along with utilities, industrial services, electricity and natural gas supply.
BAK stock can be an impressive GARP investment pick with its Zacks Rank #2, a Value Score of A and a Growth Score of B. Apart from a discounted PEG and P/E, Braskem has an impressive long-term expected growth rate of 16.8%.
LyondellBasell: Based in Houston, TX, LyondellBasell is among the leading plastics, chemical and refining companies globally with operations across 18 countries. The company’s products are used across various industries, including electronics, automotive parts, packaging, construction materials and biofuels.
LYB can also be an impressive GARP investment pick with its Zacks Rank #1, a Value Score of B and a Growth Score of B. Apart from a discounted PEG and P/E, the stock also has a solid long-term historical growth rate of 49.4%.
Have you been paying attention to shares of Integra LifeSciences (IART - Free Report) ? Shares have been on the move with the stock up 56.2% over the past month. The stock hit a new 52-week high of $16.62 in the previous session. Integra has gained 32.5% since the start of the year compared to the -4.5% move for the Zacks Medical sector and the -15.5% return for the Zacks Medical - Instruments industry.
What's Driving the Outperformance?The stock has an impressive record of positive earnings surprises, having beaten the Zacks Consensus Estimate in each of the last four quarters. In its last earnings report on May 5, 2026, Integra reported EPS of $0.54 versus consensus estimate of $0.41 while it beat the consensus revenue estimate by 2.74%.
For the current fiscal year, Integra is expected to post earnings of $2.42 per share on $1.67 in revenues. This represents a 8.52% change in EPS on a 2.24% change in revenues. For the next fiscal year, the company is expected to earn $2.57 per share on $1.73 in revenues. This represents a year-over-year change of 6.3% and 3.27%, respectively.
Valuation MetricsIntegra may be at a 52-week high right now, but what might the future hold for the stock? A key aspect of this question is taking a look at valuation metrics in order to determine if the company is due for a pullback from this level.
On this front, we can look at the Zacks Style Scores, as they provide investors with an additional way to sort through stocks (beyond looking at the Zacks Rank of a security). The individual style scores for Value, Growth, Momentum and the combined VGM Score run from A through F. The idea behind the style scores is to help investors pick the most appropriate Zacks Rank stocks based on their individual investment style.
Integra has a Value Score of B. The stock's Growth and Momentum Scores are B and D, respectively, giving the company a VGM Score of A.
In terms of its value breakdown, the stock currently trades at 6.8X current fiscal year EPS estimates, which is not in-line with the peer industry average of 22.7X. On a trailing cash flow basis, the stock currently trades at 3.9X versus its peer group's average of 15.3X. Additionally, the stock has a PEG ratio of 1.15. This isn't enough to put the company in the top echelon of all stocks we cover from a value perspective.
Zacks RankWe also need to look at the Zacks Rank for the stock, as this supersedes any trend on the style score front. Fortunately, Integra currently has a Zacks Rank of #2 (Buy) thanks to favorable earnings estimate revisions from covering analysts.
Since we recommend that investors select stocks carrying Zacks Rank of 1 (Strong Buy) or 2 (Buy) and Style Scores of A or B, it looks as if Integra fits the bill. Thus, it seems as though Integra shares could have a bit more room to run in the near term.
PRINCETON, N.J., June 02, 2026 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, today announced that chief financial officer Lea Knight will present at the 2026 Jefferies Global Healthcare Conference on June 3, 2026 at 10:30am ET.
A live webcast of the presentation will be available on the Integra LifeSciences investor relations website under EVENTS & PRESENTATIONS.
About Integra LifeSciences
Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies are trusted by healthcare professionals to deliver life-saving care. For our latest news and information, visit www.integralife.com.
Investors interested in Medical - Instruments stocks are likely familiar with Integra LifeSciences (IART - Free Report) and Masimo . But which of these two stocks presents investors with the better value opportunity right now? Let's take a closer look.
There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Style Scores highlight companies with specific traits.
Integra LifeSciences and Masimo are sporting Zacks Ranks of #2 (Buy) and #3 (Hold), respectively, right now. This means that IART's earnings estimate revision activity has been more impressive, so investors should feel comfortable with its improving analyst outlook. But this is just one factor that value investors are interested in.
Value investors analyze a variety of traditional, tried-and-true metrics to help find companies that they believe are undervalued at their current share price levels.
Our Value category highlights undervalued companies by looking at a variety of key metrics, including the popular P/E ratio, as well as the P/S ratio, earnings yield, cash flow per share, and a variety of other fundamentals that have been used by value investors for years.
IART currently has a forward P/E ratio of 6.48, while MASI has a forward P/E of 30.99. We also note that IART has a PEG ratio of 1.10. This metric is used similarly to the famous P/E ratio, but the PEG ratio also takes into account the stock's expected earnings growth rate. MASI currently has a PEG ratio of 1.81.
Another notable valuation metric for IART is its P/B ratio of 1.17. The P/B ratio is used to compare a stock's market value with its book value, which is defined as total assets minus total liabilities. For comparison, MASI has a P/B of 11.86.
Based on these metrics and many more, IART holds a Value grade of B, while MASI has a Value grade of D.
IART sticks out from MASI in both our Zacks Rank and Style Scores models, so value investors will likely feel that IART is the better option right now.
It has been about a month since the last earnings report for Integra LifeSciences (IART - Free Report) . Shares have added about 15% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Integra due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its latest earnings report in order to get a better handle on the important catalysts.
Integra Q1 Earnings & Revenues Beat Estimates Integra LifeSciences Holdings Corporation (IART - Free Report) delivered adjusted earnings per share (EPS) of 54 cents for the first quarter of 2026, which beat the Zacks Consensus Estimate by 32.8%. The metric increased 31.7% year over year.
GAAP loss per share was 6 cents in the quarter compared with the year-ago period’s loss of 33 cents.
IART’s RevenuesTotal revenues in the first quarter rose 2.4% year over year to $391.9 million. The metric topped the Zacks Consensus Estimate by 2.7%. Organically, revenues rose 1.3% year over year.
Integra’s 2026 & Q2 GuidanceFor full-year 2026, the company expects revenues to be in the range of $1.66-$1.70 billion, representing reported growth of 1.6% to 4.1%. The Zacks Consensus Estimate is pegged at $1.67 billion, indicating 2.2% year-over-year growth.
Meanwhile, the company updated its expected adjusted EPS to a range of $2.40-$2.50. The Zacks Consensus Estimate for the metric is pegged at $2.42 per share.
For the second quarter of 2026, Integra expects reported revenues in the range of $410-$425 million. The Zacks Consensus Estimate is pegged at $417.5 million.
Adjusted EPS is expected to be in the range of 44-52 cents. The Zacks Consensus Estimate for the metric is pegged at 49 cents per share.
How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a downward trend in estimates review.
The consensus estimate has shifted -10.74% due to these changes.
VGM ScoresCurrently, Integra has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. However, the stock has a grade of B on the value side, putting it in the top 40% for value investors.
Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Integra has a Zacks Rank #2 (Buy). We expect an above average return from the stock in the next few months.
Performance of an Industry PlayerIntegra belongs to the Zacks Medical - Instruments industry. Another stock from the same industry, Integer (ITGR - Free Report) , has gained 5.3% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026.
Integer reported revenues of $439.58 million in the last reported quarter, representing a year-over-year change of +0.5%. EPS of $1.20 for the same period compares with $1.31 a year ago.
For the current quarter, Integer is expected to post earnings of $1.38 per share, indicating a change of -11% from the year-ago quarter. The Zacks Consensus Estimate has changed -4.2% over the last 30 days.
Integer has a Zacks Rank #4 (Sell) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D.
It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.
Featuring daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, the research service can help you become a smarter, more self-assured investor.
Zacks Premium also includes the Zacks Style Scores.
What are the Zacks Style Scores? Developed alongside the Zacks Rank, the Zacks Style Scores are a group of complementary indicators that help investors pick stocks with the best chances of beating the market over the next 30 days.
Each stock is given an alphabetic rating of A, B, C, D or F based on their value, growth, and momentum qualities. With this system, an A is better than a B, a B is better than a C, and so on, meaning the better the score, the better chance the stock will outperform.
The Style Scores are broken down into four categories:
Value ScoreFinding good stocks at good prices, and discovering which companies are trading under their true value, are what value investors like to focus on. So, the Value Style Score takes into account ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and a host of other multiples to highlight the most attractive and discounted stocks.
Growth ScoreGrowth investors are more concerned with a stock's future prospects, and the overall financial health and strength of a company. Thus, the Growth Style Score analyzes characteristics like projected and historic earnings, sales, and cash flow to find stocks that will see sustainable growth over time.
Momentum ScoreMomentum investors, who live by the saying "the trend is your friend," are most interested in taking advantage of upward or downward trends in a stock's price or earnings outlook. Utilizing one-week price change and the monthly percentage change in earnings estimates, among other factors, the Momentum Style Score can help determine favorable times to buy high-momentum stocks.
VGM ScoreIf you like to use all three kinds of investing, then the VGM Score is for you. It's a combination of all Style Scores, and is an important indicator to use with the Zacks Rank. The VGM Score rates each stock on their shared weighted styles, narrowing down the companies with the most attractive value, best growth forecast, and most promising momentum.
How Style Scores Work with the Zacks Rank The Zacks Rank is a proprietary stock-rating model that harnesses the power of earnings estimate revisions, or changes to a company's earnings expectations, to help investors build a successful portfolio.
#1 (Strong Buy) stocks have produced an unmatched +23.7% average annual return since 1988, which is more than double the S&P 500's performance over the same time frame. However, the Zacks Rank examines a ton of stocks, and there can be more than 200 companies with a Strong Buy rank, and another 600 with a #2 (Buy) rank, on any given day.
But it can feel overwhelming to pick the right stocks for you and your investing goals with over 800 top-rated stocks to choose from.
That's where the Style Scores come in.
To maximize your returns, you want to buy stocks with the highest probability of success. This means picking stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you find yourself looking at stocks with a #3 (Hold) rank, make sure they have Scores of A or B as well to ensure as much upside potential as possible.
As mentioned above, the Scores are designed to work with the Zacks Rank, so any change to a company's earnings outlook should be a deciding factor when picking which stocks to buy.
Here's an example: a stock with a #4 (Sell) or #5 (Strong Sell) rating, even one with Style Scores of A and B, still has a downward-trending earnings outlook, and a bigger chance its share price will decrease too.
Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.
Stock to Watch: Integra LifeSciences (IART - Free Report) Headquartered in Plainsboro, NJ, Integra LifeSciences Holdings Corporation is one of the world leaders in regenerative medicine. The company develops, manufactures and markets surgical implants and medical instruments. In its first-quarter 2026 report, the company renamed two of its segments: Codman Specialty Surgical was renamed Specialty Surgery, while Tissue Technologies was renamed Tissue Reconstruction.
IART is a #2 (Buy) on the Zacks Rank, with a VGM Score of B.
It also boasts a Value Style Score of B thanks to attractive valuation metrics like a forward P/E ratio of 7.01; value investors should take notice.
Three analysts revised their earnings estimate upwards in the last 60 days for fiscal 2026. The Zacks Consensus Estimate has increased $0.10 to $2.42 per share. IART boasts an average earnings surprise of +16.8%.
With a solid Zacks Rank and top-tier Value and VGM Style Scores, IART should be on investors' short list.
Capricorn Fund Managers Ltd purchased a new position in shares of Clearwater Analytics Holdings, Inc. (NYSE:CWAN – Free Report) during the 4th quarter, according to its most recent disclosure with the Securities and Exchange Commission. The firm purchased 124,611 shares of the company’s stock, valued at approximately $3,006,000.
A number of other hedge funds and other institutional investors have also modified their holdings of CWAN. FNY Investment Advisers LLC lifted its stake in shares of Clearwater Analytics by 339.8% during the fourth quarter. FNY Investment Advisers LLC now owns 15,000 shares of the company’s stock valued at $361,000 after buying an additional 11,589 shares during the period. Trust Point Inc. acquired a new position in Clearwater Analytics in the 4th quarter valued at $221,000. Norden Group LLC purchased a new position in shares of Clearwater Analytics during the 4th quarter worth $313,000. First Bank & Trust acquired a new stake in shares of Clearwater Analytics during the fourth quarter worth $223,000. Finally, Congress Asset Management Co. grew its position in shares of Clearwater Analytics by 18.8% in the fourth quarter. Congress Asset Management Co. now owns 839,499 shares of the company’s stock valued at $20,249,000 after purchasing an additional 132,569 shares during the period. 50.10% of the stock is currently owned by hedge funds and other institutional investors.
Clearwater Analytics News Roundup Here are the key news stories impacting Clearwater Analytics this week:
Positive Sentiment: Institutional buying: Several large funds have recently increased positions (AQR, UBS, Woodline), signaling continued institutional interest that can stabilize the share base. Institutional Holdings Report Neutral Sentiment: Analyst stance is largely muted (consensus “Hold”) and several brokers have price targets clustered near the mid-$20s; that suggests limited near-term upside from analyst revisions. Neutral Sentiment: Insiders still retain large stakes (CEO Sandeep Sahai remains a >1.4M-share holder), which reduces—but does not eliminate—concerns that executives are exiting entirely. CEO SEC Filing Negative Sentiment: Clustered insider selling: Multiple senior officers sold shares the same day (CEO, CFO, CTO, CRO and another insider — ~127k shares total, ~ $3M at reported prices). Clustered top-executive sales often weigh on sentiment because they look like officers taking money off the table. Insider Trades Negative Sentiment: Options flow indicates downside positioning: unusually large put buying (~17,402 puts, ~+71% vs. average daily put volume), which can increase short-term selling pressure and volatility. Negative Sentiment: Shareholder litigation/investigation: Plaintiffs’ firm Scott+Scott launched an investigation into whether Clearwater’s directors breached fiduciary duties tied to the proposed buyout by Warburg Pincus and Permira — legal scrutiny can delay the transaction, add uncertainty to deal terms, and create potential liability. Investor Alert Insider Buying and Selling at Clearwater Analytics In other Clearwater Analytics news, CFO James S. Cox sold 21,631 shares of the stock in a transaction on Tuesday, March 31st. The shares were sold at an average price of $23.80, for a total transaction of $514,817.80. Following the transaction, the chief financial officer directly owned 485,419 shares in the company, valued at $11,552,972.20. This represents a 4.27% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which is available through this link. Also, CRO Scott Stanley Erickson sold 18,790 shares of the firm’s stock in a transaction on Tuesday, March 31st. The stock was sold at an average price of $23.80, for a total transaction of $447,202.00. Following the transaction, the executive directly owned 155,119 shares of the company’s stock, valued at approximately $3,691,832.20. This represents a 10.80% decrease in their ownership of the stock. The disclosure for this sale is available in the SEC filing. In the last three months, insiders have sold 780,842 shares of company stock valued at $18,360,889. Corporate insiders own 3.31% of the company’s stock.
Analyst Upgrades and Downgrades Several equities analysts recently weighed in on the company. Jefferies Financial Group downgraded Clearwater Analytics to a “hold” rating in a research report on Friday, January 16th. William Blair reaffirmed a “market perform” rating on shares of Clearwater Analytics in a research note on Monday, December 22nd. Warburg Research set a $24.55 price objective on shares of Clearwater Analytics in a report on Monday, December 22nd. Morgan Stanley reiterated an “equal weight” rating and set a $24.55 price objective (down from $27.00) on shares of Clearwater Analytics in a research note on Tuesday, January 27th. Finally, Oppenheimer downgraded shares of Clearwater Analytics from an “outperform” rating to a “market perform” rating in a research note on Monday, December 22nd. Three analysts have rated the stock with a Buy rating, ten have assigned a Hold rating and one has given a Sell rating to the stock. According to MarketBeat, Clearwater Analytics currently has an average rating of “Hold” and an average target price of $26.17.
View Our Latest Stock Analysis on Clearwater Analytics
Clearwater Analytics Price Performance Shares of NYSE CWAN opened at $23.80 on Monday. The company has a quick ratio of 1.83, a current ratio of 1.83 and a debt-to-equity ratio of 0.40. Clearwater Analytics Holdings, Inc. has a fifty-two week low of $15.73 and a fifty-two week high of $26.94. The business has a 50 day moving average price of $23.52 and a two-hundred day moving average price of $21.69. The firm has a market cap of $7.03 billion, a PE ratio of -169.95, a price-to-earnings-growth ratio of 3.31 and a beta of 0.64.
Clearwater Analytics Company Profile (Free Report)
Clearwater Analytics LLC is a global provider of web-based investment portfolio accounting, reporting, and analytics solutions. The company’s software-as-a-service platform automates complex processes involved in investment data aggregation, reconciliation, valuation, and regulatory reporting. Serving institutional investors—including insurers, asset managers, corporations, government entities, and asset owners—Clearwater Analytics enables clients to optimize performance visibility, risk management, and operational efficiency.
Founded in 2004 and headquartered in Boise, Idaho, Clearwater Analytics has grown its global footprint with offices across North America, Europe, and the Asia-Pacific region.
Read More Five stocks we like better than Clearwater Analytics Want to see what other hedge funds are holding CWAN? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Clearwater Analytics Holdings, Inc. (NYSE:CWAN – Free Report).
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Insiders may stand to receive substantial financial benefits not available to ordinary shareholders.
The proposed transactions may contain terms that could limit superior competing offers.
Shareholders are encouraged to contact the firm to discuss their rights and options at no cost or obligation. We would handle any matter on a contingent fee basis, whereby you would not be responsible for out-of-pocket payment of our legal fees or expenses.
, /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to:
Odyssey Marine Exploration, Inc. (NASDAQ: OMEX)'s merger with American Ocean Minerals Corporation. If you are an Odyssey shareholder, click here to learn more about your legal rights and options.
Penumbra, Inc. (NYSE: PEN)'s sale to Boston Scientific Corporation for $374.00 in cash or 3.8721 shares of Boston Scientific common stock. If you are a Penumbra shareholder, click here to learn more about your rights and options.
Sun Country Airlines Holdings, Inc. (NASDAQ: SNCY)'s sale to Allegiant Travel Company for 0.1557 shares of Allegiant common stock and $4.10 in cash for each Sun Country share. If you are a Sun Country shareholder, click here to learn more about your rights and options.
Clearwater Analytics Holdings, Inc. (NYSE: CWAN)'s sale to Permira and Warburg Pincus for $24.55 per share in cash. If you are a Clearwater shareholder, click here to learn more about your rights and options.
On behalf of shareholders, Halper Sadeh LLC may seek increased consideration, additional disclosures and information, or other relief and benefits.
Halper Sadeh LLC represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Halper Sadeh LLC
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Zachary Halper, Esq.
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NEW YORK & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Clearwater Analytics Holdings, Inc. (NYSE: CWAN) to Permira and Warburg Pincus. Under the terms of the proposed transaction, shareholders of Clearwater will receive $24.55 in cash for each share of Clearwater that they own. KSF is seeking to determine whether this consideration and the process that l.
Clearwater Analytics Holdings, Inc. (NYSE:CWAN – Get Free Report) CTO Souvik Das sold 10,000 shares of the business’s stock in a transaction on Wednesday, April 8th. The stock was sold at an average price of $24.01, for a total transaction of $240,100.00. Following the completion of the sale, the chief technology officer directly owned 200,109 shares of the company’s stock, valued at approximately $4,804,617.09. The trade was a 4.76% decrease in their position. The sale was disclosed in a filing with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.
Souvik Das also recently made the following trade(s):
On Tuesday, March 31st, Souvik Das sold 14,686 shares of Clearwater Analytics stock. The stock was sold at an average price of $23.80, for a total transaction of $349,526.80. On Monday, March 9th, Souvik Das sold 10,000 shares of Clearwater Analytics stock. The stock was sold at an average price of $23.37, for a total transaction of $233,700.00. On Wednesday, February 18th, Souvik Das sold 88,848 shares of Clearwater Analytics stock. The stock was sold at an average price of $23.44, for a total transaction of $2,082,597.12. On Monday, February 9th, Souvik Das sold 10,000 shares of Clearwater Analytics stock. The stock was sold at an average price of $23.89, for a total transaction of $238,900.00. Clearwater Analytics Price Performance Shares of NYSE CWAN opened at $24.05 on Wednesday. The firm has a market cap of $7.11 billion, a PE ratio of -171.77, a PEG ratio of 3.34 and a beta of 0.64. The firm has a fifty day moving average of $23.51 and a 200 day moving average of $21.97. The company has a debt-to-equity ratio of 0.40, a quick ratio of 1.83 and a current ratio of 1.83. Clearwater Analytics Holdings, Inc. has a one year low of $15.73 and a one year high of $25.07.
Wall Street Analysts Forecast Growth Several equities research analysts have issued reports on the stock. Weiss Ratings cut shares of Clearwater Analytics from a “hold (c)” rating to a “sell (d+)” rating in a research note on Monday, February 23rd. Wells Fargo & Company cut shares of Clearwater Analytics from an “overweight” rating to an “equal weight” rating and lowered their target price for the stock from $27.00 to $24.55 in a research note on Thursday, January 8th. Jefferies Financial Group cut shares of Clearwater Analytics to a “hold” rating in a research note on Friday, January 16th. DA Davidson reaffirmed a “neutral” rating and set a $24.55 target price on shares of Clearwater Analytics in a research note on Thursday, February 19th. Finally, Morgan Stanley reaffirmed an “equal weight” rating and set a $24.55 target price (down from $27.00) on shares of Clearwater Analytics in a research note on Tuesday, January 27th. Three research analysts have rated the stock with a Buy rating, ten have given a Hold rating and one has assigned a Sell rating to the stock. According to MarketBeat, Clearwater Analytics presently has a consensus rating of “Hold” and a consensus price target of $26.17.
Get Our Latest Report on CWAN
Institutional Trading of Clearwater Analytics Institutional investors and hedge funds have recently bought and sold shares of the stock. EverSource Wealth Advisors LLC raised its holdings in Clearwater Analytics by 211.1% in the 4th quarter. EverSource Wealth Advisors LLC now owns 1,061 shares of the company’s stock valued at $26,000 after buying an additional 720 shares during the period. Los Angeles Capital Management LLC purchased a new stake in Clearwater Analytics in the 4th quarter valued at about $26,000. SBI Securities Co. Ltd. raised its holdings in Clearwater Analytics by 627.5% in the 4th quarter. SBI Securities Co. Ltd. now owns 1,375 shares of the company’s stock valued at $33,000 after buying an additional 1,186 shares during the period. Caitong International Asset Management Co. Ltd purchased a new stake in Clearwater Analytics in the 4th quarter valued at about $33,000. Finally, Private Trust Co. NA raised its holdings in Clearwater Analytics by 643.3% in the 4th quarter. Private Trust Co. NA now owns 1,546 shares of the company’s stock valued at $37,000 after buying an additional 1,338 shares during the period. 50.10% of the stock is currently owned by hedge funds and other institutional investors.
About Clearwater Analytics (Get Free Report)
Clearwater Analytics LLC is a global provider of web-based investment portfolio accounting, reporting, and analytics solutions. The company’s software-as-a-service platform automates complex processes involved in investment data aggregation, reconciliation, valuation, and regulatory reporting. Serving institutional investors—including insurers, asset managers, corporations, government entities, and asset owners—Clearwater Analytics enables clients to optimize performance visibility, risk management, and operational efficiency.
Founded in 2004 and headquartered in Boise, Idaho, Clearwater Analytics has grown its global footprint with offices across North America, Europe, and the Asia-Pacific region.
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Special meeting of stockholders to be held on May 6, 2026Is the buyout price of $24.55 too low? PHILADELPHIA, April 16, 2026 (GLOBE NEWSWIRE) -- On April 8, 2026, Clearwater Analytics Holdings, Inc. (NYSE: CWAN) (“Clearwater”) reported that it has scheduled a special meeting of stockholders to be held on May 6, 2026, during which it will ask its investors to vote to approve the $24.55 per share stockholder buyout proposal.
As that meeting date has now been set, Kaskela Law alerts Clearwater shareholders that they now only have a limited period of time – prior to the special meeting of stockholders – to act if they wish to preserve their legal rights and options with respect to buyout transaction.
Click here to receive additional information about your rights: https://kaskelalaw.com/case/clearwater-analytics-buyout/
On December 21, 2025, Clearwater announced that it had agreed to be acquired by a group of private equity funds at a price of $24.55 per share. Following the closing of the proposed transaction, Clearwater shareholders will be cashed out of their investment position and the company’s shares will no longer be publicly traded.
Kaskela Law’s investigation has discovered that the transaction appears to have significant conflicts of interest, thus making the sales process and proposed $24.55 per share price unfair to Clearwater shareholders. Notably, at the time the transaction was announced, several analysts were maintaining price targets for Clearwater shares of over $35.00 per share.
“We are investigating this transaction and encourage Clearwater shareholders who think the buyout price is too low to promptly contact Kaskela Law to preserve their legal rights before the special meeting of stockholders” said attorney D. Seamus Kaskela, who is leading the firm’s investigation.
Clearwater shareholders are encouraged to promptly contact Kaskela Law (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750, or by email at [email protected], to preserve their legal rights and options. Investors may also request additional information about this matter by clicking on the following link (or by copying and pasting the link into your browser if necessary):
Kaskela Law exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis. For additional information about the firm, including the firm’s recent monetary recoveries for investors in mergers & acquisition litigation, please visit our website (www.kaskelalaw.com) or contact us today at (888) 715 – 1740.
KASKELA LAW LLC
D. Seamus Kaskela, Esquire
Adrienne Bell, Esquire
18 Campus Boulevard, Suite 100
Newtown Square, PA 19073
(484) 229 – 0750
www.kaskelalaw.com
This communication may constitute attorney advertising in certain jurisdictions.
NEW YORK--(BUSINESS WIRE)---- $CWAN #NYSE--Scott+Scott Attorneys at Law LLP has launched an urgent investigation into whether the directors of Clearwater Analytics Holdings, Inc. (NYSE: CWAN) breached their fiduciary duties to Clearwater's shareholders in approving a buyout by Warburg Pincus LLC and Permira Advisers LLC. Attorney Joseph A. Pettigrew is heading the investigation—what shareholders need to know:On December 20, 2025, Clearwater announced it had entered into an agreement to be bought out by an inves.
Philadelphia, Pennsylvania--(Newsfile Corp. - April 18, 2026) - On April 8, 2026, Clearwater Analytics Holdings, Inc. (NYSE: CWAN) ("Clearwater") reported that it has scheduled a special meeting of stockholders to be held on May 6, 2026, during which it will ask its investors to vote to approve the $24.55 per share stockholder buyout proposal.
As that meeting date has now been set, Kaskela Law alerts Clearwater shareholders that they now only have a limited period of time – prior to the special meeting of stockholders – to act if they wish to preserve their legal rights and options with respect to buyout transaction.
Click here to receive additional information about your rights: https://kaskelalaw.com/case/clearwater-analytics-buyout/
On December 21, 2025, Clearwater announced that it had agreed to be acquired by a group of private equity funds at a price of $24.55 per share. Following the closing of the proposed transaction, Clearwater shareholders will be cashed out of their investment position and the company's shares will no longer be publicly traded.
Kaskela Law's investigation has discovered that the transaction appears to have significant conflicts of interest, thus making the sales process and proposed $24.55 per share price unfair to Clearwater shareholders. Notably, at the time the transaction was announced, several analysts were maintaining price targets for Clearwater shares of over $35.00 per share.
Clearwater shareholders who would like to learn more about the investigation and their legal rights and options are encouraged to contact lead investigative attorney Adrienne Bell, Esq. at (484) 229 - 0750, by email at [email protected], or by filling out our online form at:
Kaskela Law exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis. For additional information about the firm, including our recent monetary recoveries for investors, please visit our website (www.kaskelalaw.com) or contact us today at (888) 715 - 1740.
KASKELA LAW LLC
D. Seamus Kaskela, Esquire
Adrienne Bell, Esquire
18 Campus Boulevard, Suite 100
Newtown Square, PA 19073
(484) 229 - 0750
www.kaskelalaw.com
This communication may constitute attorney advertising in certain jurisdictions.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/293201
Source: Kaskela Law LLC
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Clearwater Analytics Holdings, Inc. (NYSE:CWAN – Get Free Report) CFO James Cox sold 18,700 shares of the business’s stock in a transaction on Wednesday, April 15th. The stock was sold at an average price of $24.07, for a total value of $450,109.00. Following the completion of the transaction, the chief financial officer directly owned 480,419 shares in the company, valued at approximately $11,563,685.33. This represents a 3.75% decrease in their position. The transaction was disclosed in a filing with the SEC, which is accessible through this hyperlink. The sale was made to cover tax withholding obligations related to the vesting of equity awards.
Clearwater Analytics Price Performance Clearwater Analytics stock opened at $24.10 on Friday. The company has a debt-to-equity ratio of 0.40, a quick ratio of 1.83 and a current ratio of 1.83. The firm has a market cap of $7.12 billion, a P/E ratio of -172.13, a P/E/G ratio of 3.35 and a beta of 0.64. The business’s fifty day moving average is $23.54 and its two-hundred day moving average is $22.06. Clearwater Analytics Holdings, Inc. has a 52 week low of $15.73 and a 52 week high of $25.07.
Institutional Investors Weigh In On Clearwater Analytics A number of institutional investors and hedge funds have recently added to or reduced their stakes in the stock. Rockefeller Capital Management L.P. increased its holdings in Clearwater Analytics by 28.3% in the fourth quarter. Rockefeller Capital Management L.P. now owns 44,848 shares of the company’s stock valued at $1,082,000 after purchasing an additional 9,890 shares during the last quarter. Larry Mathis Financial Planning LLC bought a new stake in Clearwater Analytics in the fourth quarter valued at about $228,000. Ovata Capital Management Ltd bought a new stake in shares of Clearwater Analytics in the fourth quarter worth about $6,811,000. Alberta Investment Management Corp bought a new stake in shares of Clearwater Analytics in the fourth quarter worth about $13,850,000. Finally, Mercer Global Advisors Inc. ADV bought a new stake in shares of Clearwater Analytics in the fourth quarter worth about $400,000. Institutional investors own 50.10% of the company’s stock.
Wall Street Analyst Weigh In CWAN has been the subject of a number of recent research reports. DA Davidson restated a “neutral” rating and set a $24.55 target price on shares of Clearwater Analytics in a research report on Thursday, February 19th. UBS Group downgraded Clearwater Analytics from a “buy” rating to a “neutral” rating and dropped their target price for the stock from $30.00 to $24.55 in a research report on Monday, January 26th. Oppenheimer downgraded Clearwater Analytics from an “outperform” rating to a “market perform” rating in a research report on Monday, December 22nd. Loop Capital downgraded Clearwater Analytics from a “buy” rating to a “hold” rating and dropped their target price for the stock from $25.00 to $24.55 in a research report on Monday, December 22nd. Finally, Warburg Research set a $24.55 target price on Clearwater Analytics in a research report on Monday, December 22nd. Three equities research analysts have rated the stock with a Buy rating, ten have given a Hold rating and one has issued a Sell rating to the company’s stock. According to data from MarketBeat, Clearwater Analytics currently has a consensus rating of “Hold” and a consensus price target of $26.17.
View Our Latest Report on Clearwater Analytics
About Clearwater Analytics (Get Free Report)
Clearwater Analytics LLC is a global provider of web-based investment portfolio accounting, reporting, and analytics solutions. The company’s software-as-a-service platform automates complex processes involved in investment data aggregation, reconciliation, valuation, and regulatory reporting. Serving institutional investors—including insurers, asset managers, corporations, government entities, and asset owners—Clearwater Analytics enables clients to optimize performance visibility, risk management, and operational efficiency.
Founded in 2004 and headquartered in Boise, Idaho, Clearwater Analytics has grown its global footprint with offices across North America, Europe, and the Asia-Pacific region.
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HONG KONG, SINGAPORE & SYDNEY--(BUSINESS WIRE)--Insurance executives across Asia Pacific are accelerating into private markets. Within five years, the 150 executives surveyed by Clearwater Analytics (NYSE: CWAN) expect to allocate a third of their combined $3.8 trillion in assets to private debt, private equity, infrastructure and other alternatives up from 20% today. The infrastructure supporting these ambitions, however, is not keeping pace. Ninety-three percent of those same executives ackno.
BOISE, Idaho--(BUSINESS WIRE)--Clearwater Analytics Holdings, Inc. (NYSE: CWAN), (“CWAN” or the “Company”), the most comprehensive technology platform for investment management, will release financial results for the first quarter ended March 31, 2026 after the U.S. financial markets close on Thursday, May 7, 2026. As a result of the execution of a definitive agreement (the “Merger Agreement”) pursuant to which an investor group led by Permira and Warburg Pincus will acquire all of the outstand.
Wall Street analysts expect Clearwater Analytics (CWAN - Free Report) to post quarterly earnings of $0.16 per share in its upcoming report, which indicates a year-over-year increase of 23.1%. Revenues are expected to be $222.99 million, up 75.8% from the year-ago quarter.
The current level reflects no revision in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reappraised their initial projections over this period.
Prior to a company's earnings release, it is of utmost importance to factor in any revisions made to the earnings projections. These revisions serve as a critical gauge for predicting potential investor behaviors with respect to the stock. Empirical studies consistently reveal a strong link between trends in earnings estimate revisions and the short-term price performance of a stock.
While investors typically rely on consensus earnings and revenue estimates to gauge how the business may have fared during the quarter, examining analysts' projections for some of the company's key metrics often helps gain a deeper insight.
That said, let's delve into the average estimates of some Clearwater Analytics metrics that Wall Street analysts commonly model and monitor.
The combined assessment of analysts suggests that 'Number of Clients' will likely reach 2,602 . Compared to the current estimate, the company reported 1,400 in the same quarter of the previous year.
Analysts' assessment points toward 'Net revenue retention rate' reaching 109.7%. Compared to the current estimate, the company reported 114.0% in the same quarter of the previous year.
The average prediction of analysts places 'Total ARR' at $865.66 million. The estimate is in contrast to the year-ago figure of $493.90 million.
View all Key Company Metrics for Clearwater Analytics here>>>
Clearwater Analytics shares have witnessed a change of +1.1% in the past month, in contrast to the Zacks S&P 500 composite's +10.3% move. With a Zacks Rank #3 (Hold), CWAN is expected closely follow the overall market performance in the near term. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> .
BOISE, Idaho--(BUSINESS WIRE)--Clearwater Analytics Holdings, Inc. (NYSE: CWAN) (“CWAN” or the “Company”), the most comprehensive technology platform for investment management, today announced its financial results for the quarter ended March 31, 2026. “We delivered a strong start to 2026 with Q1 revenue of $221.2 million, up 74% year-over-year. GenAI tools are woven into the fabric of our organization, enabling both technical and non-technical employees to deliver internal automation and new p.
Clearwater Analytics (CWAN - Free Report) came out with quarterly earnings of $0.16 per share, in line with the Zacks Consensus Estimate . This compares to earnings of $0.13 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of -2.44%. A quarter ago, it was expected that this automated investment accounting software developer would post earnings of $0.15 per share when it actually produced earnings of $0.15, delivering no surprise.
Over the last four quarters, the company has not been able to surpass consensus EPS estimates.
Clearwater Analytics, which belongs to the Zacks Internet - Software industry, posted revenues of $221.23 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 0.79%. This compares to year-ago revenues of $126.86 million. The company has topped consensus revenue estimates three 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.
Clearwater Analytics shares have added about 0.6% since the beginning of the year versus the S&P 500's gain of 7.6%.
What's Next for Clearwater Analytics?While Clearwater Analytics 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 Clearwater Analytics 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 $232.66 million in revenues for the coming quarter and $0.70 on $949.6 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.
One other stock from the same industry, PagerDuty (PD - Free Report) , is yet to report results for the quarter ended April 2026.
This software developer is expected to post quarterly earnings of $0.24 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
PagerDuty's revenues are expected to be $119.18 million, down 0.5% from the year-ago quarter.
BOISE, Idaho & NEW YORK & CHICAGO & LONDON & HONG KONG--(BUSINESS WIRE)--Clearwater Analytics (NYSE: CWAN) today released the 2026 Insurance Investment Outsourcing Report (IIOR), produced in partnership with DCS Financial Consulting. The report captures $5.5 trillion in third-party general account insurance assets under management across 96 asset managers, a 23% increase year-over-year and a 65% increase since 2021, alongside $1.8 trillion in assets under advisement across 12 investment consult.
Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. But finding a great growth stock is not easy at all.
By their very nature, these stocks carry above-average risk and volatility. Moreover, if a company's growth story is over or nearing its end, betting on it could lead to significant loss.
However, the task of finding cutting-edge growth stocks is made easy with the help of the Zacks Growth Style Score (part of the Zacks Style Scores system), which looks beyond the traditional growth attributes to analyze a company's real growth prospects.
Clearwater Analytics (CWAN - Free Report) is on the list of such stocks currently recommended by our proprietary system. In addition to a favorable Growth Score, it carries a top Zacks Rank.
Research shows that stocks carrying the best growth features consistently beat the market. And returns are even better for stocks that possess the combination of a Growth Score of A or B and a Zacks Rank #1 (Strong Buy) or 2 (Buy).
While there are numerous reasons why the stock of this automated investment accounting software developer is a great growth pick right now, we have highlighted three of the most important factors below:
Earnings GrowthArguably nothing is more important than earnings growth, as surging profit levels is what most investors are after. For growth investors, double-digit earnings growth is highly preferable, as it is often perceived as an indication of strong prospects (and stock price gains) for the company under consideration.
While the historical EPS growth rate for Clearwater Analytics is 120.3%, investors should actually focus on the projected growth. The company's EPS is expected to grow 28.1% this year, crushing the industry average, which calls for EPS growth of 23.8%.
Cash Flow GrowthWhile cash is the lifeblood of any business, higher-than-average cash flow growth is more important and beneficial for growth-oriented companies than for mature companies. That's because, growth in cash flow enables these companies to expand their businesses without depending on expensive outside funds.
Right now, year-over-year cash flow growth for Clearwater Analytics is 243.2%, which is higher than many of its peers. In fact, the rate compares to the industry average of 6.9%.
While investors should actually consider the current cash flow growth, it's worth taking a look at the historical rate too for putting the current reading into proper perspective. The company's annualized cash flow growth rate has been 43.5% over the past 3-5 years versus the industry average of 17%.
Promising Earnings Estimate RevisionsSuperiority of a stock in terms of the metrics outlined above can be further validated by looking at the trend in earnings estimate revisions. A positive trend is of course favorable here. Empirical research shows that there is a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
There have been upward revisions in current-year earnings estimates for Clearwater Analytics. The Zacks Consensus Estimate for the current year has surged 2.1% over the past month.
Bottom LineWhile the overall earnings estimate revisions have made Clearwater Analytics a Zacks Rank #2 stock, it has earned itself a Growth Score of B based on a number of factors, including the ones discussed above.
You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
This combination positions Clearwater Analytics well for outperformance, so growth investors may want to bet on it.
BOISE, Idaho & NEW YORK & CHICAGO & LONDON & HONG KONG--(BUSINESS WIRE)--Clearwater Analytics (NYSE: CWAN) today introduced new AI-enabled products built on the same trusted investment data foundation supporting more than $10 trillion in global assets. The new products extend Clearwater's platform across operations, risk, and private markets workflows, helping institutional investors move faster without sacrificing transparency, control, or auditability. “Every firm in this industry wants AI th.
Clearwater Analytics (NYSE: CWAN) today introduced new AI-enabled products built on the same trusted investment data foundation supporting more than $10 trillion in global assets.
The new products extend Clearwater’s platform across operations, risk, and private markets workflows, helping institutional investors move faster without sacrificing transparency, control, or auditability.
“Every firm in this industry wants AI that works,” said Sandeep Sahai, Chief Executive Officer at Clearwater Analytics. “What firms are discovering is that AI is only as good as the data it runs on. Clearwater was built around a trusted investment record. That allows firms to bring AI directly into the workflows that drive investment operations, risk, and portfolio oversight.”
The announcement includes three new products: Clearwater Compass, Total Portfolio Oversight, and Fund Analytics.
Clearwater Compass
AI for Investment Operations and Accounting
Clearwater Compass embeds AI into investment operations and accounting workflows, helping teams automate exception management, improve reconciliation transparency, and accelerate close processes with full auditability.
The first Compass capabilities available today are Smart Suspense and Recon Transparency.
Smart Suspense automates the matching and categorization of unapplied cash, replacing spreadsheet-driven workflows with a centralized operational workspace and complete audit visibility. Recon Transparency gives clients live visibility into reconciliation breaks Clearwater processes on their behalf, including source files, resolution status, root-cause analysis, and collaborative workflows that replace manual email chains. “When reconciliations, exceptions, and close workflows are connected directly to the investment record, firms can move faster while maintaining the controls institutional investors expect,” said Lisa Widdowson, Head of Product, Insurance and Asset Owners at Clearwater Analytics.
Total Portfolio Oversight
One View Across Investment and Risk
Developed with Blackstone and now live in production, Total Portfolio Oversight brings investment and risk teams together on a shared view spanning public and private assets. The solution combines portfolio oversight, risk exposure, shock analysis, and direct portfolio query capabilities in one experience, all connected to the same trusted investment record. Total Portfolio Oversight is currently being expanded to a select group of institutional beta clients.
Fund Analytics
Bringing Structure to Private Markets Data
Fund Analytics extends Clearwater’s platform into private markets, where investment teams still rely heavily on fragmented GP reports, capital statements, PDFs, spreadsheets, and manual processes.
The solution uses AI to extract, validate, and structure private markets data across funds, exposures, and performance metrics. Investment teams gain earlier visibility into portfolio changes, look-through exposure, peer benchmarking, and scenario analysis, all connected to the same trusted investment record used across the broader Clearwater platform.
Together, these products extend Clearwater’s investment platform across operations, risk, and private markets, helping institutional investors move faster with trusted data and embedded intelligence.
To learn more, visit Clearwater Analytics.
About CWAN
Clearwater Analytics (NYSE: CWAN) is transforming investment management with the industry’s most comprehensive cloud-native platform for institutional investors across global public and private markets. While legacy systems create risk, inefficiency, and data fragmentation, CWAN’s single-instance, multi-tenant architecture delivers real-time data and AI-driven insights throughout the investment lifecycle. The platform eliminates information silos by integrating portfolio management, trading, investment accounting, reconciliation, regulatory reporting, performance, compliance, and risk analytics in one unified system. Serving leading insurers, asset managers, hedge funds, banks, corporations, and governments, CWAN supports over $10 trillion in assets globally.Learn more at www.cwan.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260603752616/en/
BOISE, Idaho & NEW YORK & CHICAGO & LONDON & HONG KONG--(BUSINESS WIRE)--Clearwater Analytics (NYSE: CWAN) today announced new factor risk capabilities for hedge funds and asset managers, helping investment teams make faster decisions with greater visibility into portfolio risk. For many firms, factor risk remains disconnected from the investment process. Portfolio managers often wait hours or until the next day to understand the risk implications of a trade, while Chief Investment Officers (CI.
ArrowMark Colorado Holdings LLC lowered its holdings in Legend Biotech Corporation Sponsored ADR (NASDAQ: LEGN) by 4.6% during the third quarter, according to its most recent filing with the Securities and Exchange Commission. The fund owned 938,678 shares of the company's stock after selling 44,832 shares during the quarter. ArrowMark Colorado Holdings LLC
Legend Biotech Corporation Sponsored ADR (NASDAQ:LEGN – Get Free Report) has been assigned an average rating of “Moderate Buy” from the fifteen research firms that are presently covering the company, Marketbeat reports. One equities research analyst has rated the stock with a sell rating, three have issued a hold rating and eleven have given a buy rating to the company. The average 12-month price target among brokerages that have issued a report on the stock in the last year is $58.3077.
A number of equities research analysts have weighed in on LEGN shares. Morgan Stanley decreased their price target on shares of Legend Biotech from $50.00 to $49.00 and set an “overweight” rating on the stock in a research note on Wednesday, March 11th. UBS Group reduced their price objective on shares of Legend Biotech from $54.00 to $48.00 and set a “buy” rating for the company in a report on Monday, December 8th. Cantor Fitzgerald decreased their target price on shares of Legend Biotech from $75.00 to $74.00 and set an “overweight” rating on the stock in a research report on Wednesday, December 17th. Jefferies Financial Group reissued a “buy” rating and issued a $69.00 price target on shares of Legend Biotech in a research report on Tuesday, March 10th. Finally, Oppenheimer assumed coverage on shares of Legend Biotech in a research note on Wednesday, January 7th. They set an “outperform” rating and a $75.00 price target for the company.
View Our Latest Analysis on LEGN
Legend Biotech Price Performance Legend Biotech stock opened at $19.14 on Friday. The business has a 50 day moving average price of $18.19 and a two-hundred day moving average price of $24.55. Legend Biotech has a 12 month low of $16.24 and a 12 month high of $45.30. The stock has a market cap of $3.54 billion, a price-to-earnings ratio of -23.93 and a beta of 0.08.
Legend Biotech (NASDAQ:LEGN – Get Free Report) last released its quarterly earnings data on Wednesday, March 11th. The company reported $0.01 earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of ($0.17) by $0.18. The business had revenue of $306.30 million for the quarter, compared to analysts’ expectations of $310.21 million. Legend Biotech had a negative return on equity of 21.93% and a negative net margin of 28.86%.Legend Biotech’s quarterly revenue was up 64.2% on a year-over-year basis. During the same period in the previous year, the business posted $0.07 earnings per share. On average, analysts expect that Legend Biotech will post -1.31 earnings per share for the current fiscal year.
Insider Activity at Legend Biotech In related news, CEO Ying Huang sold 9,936 shares of the firm’s stock in a transaction that occurred on Wednesday, March 25th. The stock was sold at an average price of $8.77, for a total transaction of $87,138.72. Following the completion of the transaction, the chief executive officer owned 247,438 shares in the company, valued at $2,170,031.26. This trade represents a 3.86% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available through the SEC website. 0.02% of the stock is owned by company insiders.
Institutional Inflows and Outflows Hedge funds have recently bought and sold shares of the stock. Clearstead Advisors LLC boosted its stake in shares of Legend Biotech by 76.5% in the 3rd quarter. Clearstead Advisors LLC now owns 847 shares of the company’s stock valued at $28,000 after purchasing an additional 367 shares in the last quarter. Parallel Advisors LLC grew its holdings in shares of Legend Biotech by 171.9% in the 3rd quarter. Parallel Advisors LLC now owns 1,047 shares of the company’s stock worth $34,000 after purchasing an additional 662 shares during the last quarter. OFI Invest Asset Management increased its position in shares of Legend Biotech by 102.6% during the 3rd quarter. OFI Invest Asset Management now owns 1,228 shares of the company’s stock worth $40,000 after purchasing an additional 622 shares in the last quarter. Raymond James Financial Inc. bought a new position in Legend Biotech during the 2nd quarter valued at about $78,000. Finally, Harvest Fund Management Co. Ltd bought a new position in Legend Biotech during the 3rd quarter valued at about $104,000. 70.89% of the stock is currently owned by institutional investors and hedge funds.
About Legend Biotech (Get Free Report)
Legend Biotech (NASDAQ: LEGN) is a commercial-stage biopharmaceutical company specializing in the development and commercialization of chimeric antigen receptor T-cell (CAR-T) therapies for oncology. Headquartered in Somerset, New Jersey, with research and development operations in Shanghai, the company leverages a global infrastructure to advance innovative cellular therapies. Legend Biotech pursues a strategy of strategic collaboration to extend its reach, most notably through its partnership with Janssen Biotech, a subsidiary of Johnson & Johnson.
The company’s lead asset, ciltacabtagene autoleucel (commercially marketed as Carvykti), is a B-cell maturation antigen (BCMA)–directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma.
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Legend Biotech (LEGN +4.07%) was one of the healthier healthcare stocks on the market as the trading week kicked off on Monday. Not one, but two, bullish analyst updates helped propel the biotech stock to a sturdy 18% gain on Monday, a performance that sharply contrasted with the 0.2% slump of the S&P 500 index.
A pharmaceutical giant swoops That morning, both H.C. Wainwright's Mitchell Kapoor and RBC Capital's Leonid Timashev reiterated their equivalents of buy recommendations on Legend. Of the pair, Timashev is the more bullish, as his price target is $62 per share, while Kapoor's is $50.
Image source: Getty Images.
According to reports, the RBC prognosticator was inspired by Eli Lilly's announcement early Monday that it is buying clinical-stage oncology drug developer Kelonia Therapeutics in a deal potentially worth up to $7 billion. Like Kelonia, Legend harnesses chimeric antigen receptor T-cell therapy (CAR-T) in its investigational drugs.
As for H.C. Wainwright's Kapoor, according to reports, he waxed bullish in his update about the generally encouraging progress of all Legend pipeline programs. He noted that data from an early stage in vivo trial of the company's CD19/CD20 should be published in the near future. If successful, this form of therapy could hold great promise for the treatment of certain cancers.
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Potentially legendary It's understandable that, as Timashev pointed out, the Eli Lilly/Kelonia deal sparked excitement about Legend's future. For once, though, this isn't just hope or hype -- Legend has innovative, very promising science supporting its pipeline programs. This is absolutely a biotech to watch, in my view, purely on the strength of those programs.
Eric Volkman has no position in any of the stocks mentioned. The Motley Fool recommends Legend Biotech. The Motley Fool has a disclosure policy.
Legend Biotech Corporation Sponsored ADR (LEGN - Free Report) shares ended the last trading session 18.4% higher at $25.07. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 21.6% gain over the past four weeks.
The sudden rise in the stock price is likely fueled by investor optimism over the continued strong sales of Carvykti, Legend Biotech’s one-time therapy for relapsed or refractory multiple myeloma, developed and marketed in partnership with Johnson & Johnson. The company has a broad clinical pipeline comprising several oncology candidates being developed across various stages.
This company is expected to post quarterly loss of $0.02 per share in its upcoming report, which represents a year-over-year change of +71.4%. Revenues are expected to be $308.38 million, up 58.1% from the year-ago quarter.
While earnings and revenue growth expectations are important in evaluating the potential strength in a stock, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
For Legend Biotech, the consensus EPS estimate for the quarter has been revised 17.5% lower over the last 30 days to the current level. And a negative trend in earnings estimate revisions doesn't usually translate into price appreciation. So, make sure to keep an eye on LEGN going forward to see if this recent jump can turn into more strength down the road.
The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>
Legend Biotech belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Harmony Biosciences Holdings, Inc. (HRMY - Free Report) , closed the last trading session 1.5% lower at $29.53. Over the past month, HRMY has returned 8.2%.
Harmony Biosciences' consensus EPS estimate for the upcoming report has remained unchanged over the past month at $0.76. Compared to the company's year-ago EPS, this represents a change of -2.6%. Harmony Biosciences currently boasts a Zacks Rank of #5 (Strong Sell).
In my opinion, Legend Biotech Corporation is an attractive acquisition target for Johnson & Johnson. Carvykti, which they are jointly developing, is quickly catching up in sales with Darzalex, J&J's blockbuster for the treatment of multiple myeloma. So, sales of Carvykti reached $597 million in Q1, up 61.8% year-on-year, beating my 'best case' scenario by $15 million.
April 28, 2026 08:00 ET | Source: Legend Biotech USA Inc.
SOMERSET, N.J., April 28, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will host a conference call for investors at 8:00 am ET on Tuesday, May 12, 2026, to review first quarter 2026 financial results.
During the conference call and accompanying webcast, senior management will provide an overview of quarterly financial performance.
Investors and other interested parties may access the live audio webcast via this weblink.
A replay of the webcast, along with the earnings press release, will be available in the Investor Relations section of the Legend Biotech website under Events and Presentation approximately two hours after the conclusion of the call.
ABOUT LEGEND BIOTECH
With over 2,900 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at www.legendbiotech.com and follow us on X (formerly Twitter) and LinkedIn.
Leading experts across cell therapy, oncology, and immunology will provide strategic input as Legend advances and expands beyond its current portfolio May 04, 2026 08:00 ET | Source: Legend Biotech USA Inc.
SOMERSET, N.J., May 04, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced the engagement with a group of distinguished scientific advisors who will provide strategic input as Legend advances its pipeline and future research priorities.
The advisors, who include Renier Brentjens, M.D., Ph.D., Spencer Fisk, Carl June, M.D., Maximilian F. Konig, M.D., Anthony Polverino, Ph.D., and Georg Schett, M.D., bring deep expertise spanning oncology, immunology, development, and manufacturing of cell-based therapies.
“These advisors bring an exceptional breadth of experience that will help guide our scientific priorities and identify new opportunities for innovation,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “As we look to advance and expand beyond our current portfolio, their perspectives will help shape our long-term scientific direction as we build a diversified, next-generation cell therapy pipeline focused on areas of high unmet need.”
Through ongoing engagement, these advisors will contribute their perspectives across emerging science, translational research, clinical development, and manufacturing priorities, including the identification of future areas of unmet need.
Collectively, these advisors reinforce the evolution of Legend Biotech as an end-to-end cell therapy company and the advancement of a next-generation pipeline with the potential to expand patient access and unlock new therapeutic possibilities.
About the Advisors
Renier Brentjens, M.D., Ph.D. – A pioneer in CAR-T cell therapy, Dr. Brentjens serves as Deputy Director and Chair of the Department of Medicine at Roswell Park Comprehensive Cancer Center. He pioneered the early clinical development of CD19-directed CAR-T cell therapies, developed armored CAR-T cells to overcome the tumor microenvironment, and is actively exploring preclinical and clinical work advancing CAR-Ts against solid tumor antigens. Recently, Dr. Brentjens was named a recipient of the Warren Alpert Foundation Prize for his pioneering applications of CAR-T cell therapy.Spencer Fisk – A seasoned CMC and technical operations leader, Mr. Fisk currently serves as Chief Technology & Quality Officer at Ottimo Pharma. At Novartis, he initiated CMC development and later led the manufacturing readiness for the approval and global commercial launch of the first FDA-approved CAR-T cell therapy for acute lymphoblastic leukemia (ALL). He brings more than 35 years of industry experience from Merck, Genentech, and other leading and innovative biopharmaceutical organizations.Carl June, M.D. – A globally recognized immunologist and pioneer of CAR-T therapy, Dr. June led the development of the first U.S. Food and Drug Administration (FDA)-approved CAR-T therapy and co-founded several biotech companies. He is Director of the Center for Cellular Immunotherapies at the University of Pennsylvania and Director of the Parker Institute for Cancer Immunotherapy. Dr. June’s lab studies various mechanisms of lymphocyte activation related to immune tolerance and adoptive immunotherapy for cancer and chronic infection.Maximilian F. Konig, M.D. – A physician-scientist, Director of the Cellular Therapy Program (Autoimmunity), and Co-Director of the Center for Autoimmunity and Immuno-Oncology at Johns Hopkins University, Dr. Konig specializes in rheumatology and immunology. His lab pioneers the development of antigen-specific and precision immunotherapy platforms for autoimmune diseases. He is also the scientific co-founder of Winnow Therapeutics.Anthony Polverino, Ph.D. – A veteran R&D leader in oncology and immunology, Dr. Polverino previously served as Chief Scientific Officer at Zymeworks and Kite Pharma, where he contributed to the approval of a CD19-targeted CAR-T cell therapy. He brings more than two decades of research leadership experience from Amgen and other biopharmaceutical organizations.Georg Schett, M.D. – A leading rheumatologist and immunologist, Dr. Schett serves as Professor of Internal Medicine, Head of the Department of Medicine 3 - Rheumatology and Immunology at Uniklinikum Erlangen and Vice President of Research at Friedrich-Alexander-Universität Erlangen-Nürnberg. He pioneered the application of CD19-directed CAR-T therapy in autoimmune diseases, including early clinical studies demonstrating drug-free remission in patients with severe lupus. About Legend Biotech
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI® patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X and LinkedIn.
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives, and the advancement of its pipeline and product portfolio. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2026. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
May 12, 2026 07:00 ET | Source: Legend Biotech USA Inc.
CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales increased 62% versus first quarter of 2025 to approximately $597 millionCARVYKTI® now available across 18 global markets, following recent launches in Italy, Poland, the Czech Republic, and AustraliaAdvanced early-stage cell therapy portfolio, with multiple data presentations expected at medical conferences in 2026Cash and cash equivalents, and time deposits of $834.6 million, as of March 31, 2026. SOMERSET, N.J., May 12, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its first quarter 2026 unaudited financial results and key corporate highlights.
“We believe CARVYKTI’s continued adoption and strong year‑over‑year growth reinforce our leadership in BCMA CAR‑T and the strength of our underlying operating model,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “As scale continues to build, we are seeing operating leverage translate into improving margins, supporting our path toward sustainable profitability. This continued progress is enabling us to advance our broad pipeline of cell therapy programs and extend the impact of our platform to address unmet needs for patients across multiple indications.”
Key Business Developments
Compared to the first quarter of 2025, CARVYKTI® net trade sales increased 62% in the first quarter of 2026 to approximately $597 million, with U.S. net trade sales growth of 36% and ex-U.S. net trade sales growth of 222%.Launched CARVYKTI® in Italy, Poland, the Czech Republic, and Australia, bringing availability to more than 300 global sites and 18 global markets.Continued to optimize CARVYKTI® manufacturing capabilities, including increasing manufacturing success rate to 99%, decreasing turnaround time, and delivering over 95% on-time order releases for final product delivery date during the first quarter of 2026.Advanced early-stage cell therapy portfolio, with multiple data presentations expected at medical conferences in 2026.In April 2026, achieved milestones totaling $55 million in connection with the Janssen Agreement (as defined below).Cash and cash equivalents, and time deposits of $834.6 million as of March 31, 2026, which Legend Biotech believes will provide financial runway beyond 2026, when Legend Biotech believes it will achieve a company-wide profit1. First Quarter 2026 Financial Results
Cash Position: Cash and cash equivalents, and time deposits were $834.6 million as of March 31, 2026.
Collaboration Revenue: Collaboration revenue was $298.4 million for the three months ended March 31, 2026, compared to $185.6 million for the three months ended March 31, 2025. The increase of $112.8 million was due to an increase in revenue generated from sales of CARVYKTI® in connection with the Janssen collaboration and license agreement (the “Janssen Agreement”).
License and Other Revenue: License revenue was $6.7 million for the three months ended March 31, 2026, compared to $9.4 million for the three months ended March 31, 2025. The decrease of $2.7 million was primarily attributed to revenue recognized under the license agreement with Novartis Pharma AG, which was recognized over time as Legend Biotech conducts a Phase 1 clinical trial for LB2102.
Cost of Collaboration Revenue: Cost of collaboration revenue was $175.4 million for the three months ended March 31, 2026, compared to $69.5 million for the three months ended March 31, 2025. The increase of $105.9 million was primarily due to Legend Biotech’s share of the cost of sales in connection with CARVYKTI® sales under the Janssen Agreement, as well as one-time additional costs incurred for capacity expansion and depreciation charges.
Research and Development Expenses: Research and development expenses were $85.7 million for the three months ended March 31, 2026, compared to $101.9 million for the three months ended March 31, 2025. The decrease of $16.2 million was primarily driven by lower expenditures in the cilta-cel clinical program as the patient dosing phases of major trials concluded, partially offset by higher pipeline-related research and development activities.
Administrative Expenses: Administrative expenses were $40.0 million for the three months ended March 31, 2026, compared to $31.5 million for the three months ended March 31, 2025. The increase of $8.5 million was primarily driven by higher professional fees.
Selling and Distribution Expenses: Selling and distribution expenses were $50.1 million for the three months ended March 31, 2026, compared to $41.0 million for the three months ended March 31, 2025. The increase of $9.1 million was primarily due to higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities, which rose with collaboration revenue.
Operating loss: Operating loss for the three months ended March 31, 2026, was $49.8 million compared to $51.7 million for the three months ended March 31, 2025. The year-over-year improvement of $1.9 million was primarily due to higher gross profit from CARVYKTI®.
Net Loss: Net loss was $54.3 million for the three months ended March 31, 2026, compared to a net loss of $101.0 million for the three months ended March 31, 2025. The year-over-year improvement of $46.7 million was primarily driven by lower unrealized foreign currency exchange losses compared to the prior period, as well as improved operating performance reflecting higher gross profit from CARVYKTI®.
Adjusted Net Loss: Adjusted net loss was $10.5 million for the three months ended March 31, 2026, compared to an adjusted net loss of $27.0 million for the three months ended March 31, 2025. The year-over-year improvement of $16.5 million was primarily driven by improved operating performance, reflecting higher gross profit from CARVYKTI®.
_____________________
1 Company-wide profit defined as Adjusted Net Income
Webcast/Conference Call Details:
Legend Biotech will host its quarterly earnings call and webcast today at 8:00 am ET. To access the webcast, please visit this weblink.
A replay of the webcast will be available on Legend Biotech’s website at https://investors.legendbiotech.com/events-and-presentations.
About Legend Biotech
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X and LinkedIn.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to the expected timing of initiation, completion, and results and data of Legend Biotech’s early-stage cell therapy portfolio; statements relating to the expected timing of initiation, completion, and results and data of Legend Biotech’s early-stage cell therapy portfolio; statements relating to CARVYKTI®, including Legend Biotech’s expectations for CARVYKTI® and its therapeutic potential; statements related to Legend Biotech’s ability to fund its operations beyond 2026 and to achieve profitability in 2026; and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the Securities and Exchange Commission (SEC) on March 10, 2026 and Legend Biotech’s other filings with the SEC. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
(UNAUDITED, DOLLARS IN MILLIONS, EXCEPT PER SHARE DATA)
Three Months Ended
March 31, 2026 2025REVENUE License and other revenue*$6.7 $9.4 Collaboration revenue 298.4 185.6 Total revenue 305.1 195.0 Cost of collaboration revenue (175.4) (69.5)Cost of license and other revenue (0.5) (1.8)Research and development expenses (85.7) (101.9)Administrative expenses (40.0) (31.5)Selling and distribution expenses (50.1) (41.0)Other operating expenses** (3.2) (1.0)Operating loss (49.8) (51.7)Finance costs (5.5) (5.1)Finance income 7.3 12.1 Other expense, net (5.1) (54.5)Loss before tax (53.1) (99.2)Income tax expense (1.2) (1.8)Net loss$(54.3) $(101.0) LOSS PER SHARE Basic$(0.15) $(0.27)Diluted$(0.15) $(0.27) Weighted average shares outstanding: Basic 370.2 367.5 Diluted 370.2 367.5 *Certain prior year amounts included within other revenue have been combined into the license and other revenue line for comparative purposes.
** Certain prior year amounts have been reclassified to present loss on asset impairment into the other operating expenses line for comparative purposes.
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(DOLLARS IN MILLIONS)
March 31, 2026
December 31, 2025
(Unaudited) NON-CURRENT ASSETS Property, plant and equipment$121.4 $116.3 Right-of-use assets 331.1 285.2 Collaboration prepaid leases 35.0 72.7 Other non-current assets 26.5 12.4 Total non-current assets 514.0 486.6 CURRENT ASSETS Collaboration inventories, net 37.1 32.0 Trade receivables 1.7 13.1 Prepayments, other receivables and other assets 209.3 253.4 Time deposits 188.2 46.7 Cash and cash equivalents 646.4 901.9 Total current assets 1,082.7 1,247.1 TOTAL ASSETS$1,596.7 $1,733.7 CURRENT LIABILITIES Trade payables$74.3 $83.0 Tax payable 20.3 19.2 Other payables and accruals 130.2 195.4 Lease liabilities 11.2 7.4 Contract liabilities 6.0 11.3 Collaboration interest-bearing advanced funding 266.0 319.1 Other current liabilities 1.1 1.0 Total current liabilities 509.1 636.4 NON-CURRENT LIABILITIES Lease liabilities long term 112.1 87.2 Other non-current liabilities 7.8 8.0 Total non-current liabilities 119.9 95.2 TOTAL LIABILITIES$629.0 $731.6 EQUITY Share capital 0.1 0.1 Reserves 967.6 1,002.0 Total equity$967.7 $1,002.1 TOTAL LIABILITIES AND SHAREHOLDER'S EQUITY$1,596.7 $1,733.7 LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(UNAUDITED; DOLLARS IN MILLIONS)
Three Months Ended March 31, 2026 2025Loss before tax$(53.1) $(99.2)Cash flows used in operating activities (85.1) (103.6)Cash flows (used in) provided by investing activities (168.0) 256.6 Cash flows (used in) provided by financing activities (1.2) 0.6 Effect of foreign exchange rate changes, net (1.2) 1.4 Net (decrease) increase in cash and cash equivalents (255.5) 155.0 Cash and cash equivalents at beginning of the period 901.9 286.7 CASH AND CASH EQUIVALENTS AT END OF THE PERIOD$646.4 $441.7 ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS Cash and bank balances$834.6 $1,005.5 Less: Pledged deposits — 0.1 Time deposits 188.2 563.7 Cash and cash equivalents as stated in the statement of financial position$646.4 $441.7 RECONCILIATION OF IFRS TO NON-IFRS MEASURES
We use Adjusted Net Loss and Adjusted Net Loss per Share (which we sometimes refer to as “Adjusted EPS” “ANL per Share”) as performance metrics. Adjusted Net Loss and ANL per share are not defined under IFRS, are not a measure of operating income, operating performance, or liquidity presented in accordance with IFRS, and are subject to important limitations. Our use of Adjusted Net Loss has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under IFRS. For example:
Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted Net Loss does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements.Adjusted Net Loss excludes unrealized foreign exchange gain or loss.Adjusted Net Loss does not reflect changes in, or cash requirements for, our working capital needs.In addition, Adjusted Net Loss excludes such as share based compensation expense, which has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy. Also, our definition of Adjusted Net Loss and ANL per Share may not be the same as similarly titled measures used by other companies.
However, we believe that providing information concerning Adjusted Net Loss and ANL per Share enhances an investor’s understanding of our financial performance. We use Adjusted Net Loss as a performance metric that guides management in its operation of and planning for the future of the business. We believe that Adjusted Net Loss provides a useful measure of our operating performance from period to period by excluding certain items that we believe are not representative of our core business. We define Adjusted Net Loss as net loss adjusted for (1) non-cash items such as depreciation and amortization, share based compensation, impairment loss, and (2) unrealized foreign exchange gain or loss.
ANL per Share is computed by dividing Adjusted Net Loss by the weighted average shares outstanding.
A reconciliation between Adjusted Net Loss and Net Loss, the most directly comparable measure under IFRS, has been provided in the table below.
LEGEND BIOTECH CORPORATION
RECONCILIATION OF IFRS TO NON-IFRS
(UNAUDITED; DOLLARS IN MILLIONS, EXCEPT PER SHARE DATA) Three Months ended March 31, 2026 2025Net loss$(54.3) $(101.0)Depreciation and amortization 15.7 5.3 Share-based compensation 19.3 15.9 Impairment charges (1) 2.9 1.0 Unrealized foreign exchange loss/(gain) (2) 5.9 51.8 Adjusted net loss (ANL)$(10.5) $(27.0) ANL per share: ANL per share - basic$(0.03) $(0.07)ANL per share - diluted$(0.03) $(0.07) (1) Included in Other operating expenses
(2) Included in Other income/(expense), net
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Legend Biotech Corp (NASDAQ:LEGN) reported downbeat results for the first quarter on Tuesday.
The company posted quarterly losses of 3 cents per share which missed the analyst consensus estimate of losses of 2 cents per share. The company reported quarterly sales of $305.100 million which missed the analyst consensus estimate of $307.035 million.
Legend Biotech shares rose 1.3% to trade at $28.63 on Wednesday.
These analysts made changes to their price targets on Legend Biotech following earnings announcement.
RBC Capital analyst Leonid Timashev maintained Legend Biotech with an Outperform rating and raised the price target from $62 to $64. Morgan Stanley analyst Matthew Harrison maintained the stock with an Overweight rating and lowered the price target from $49 to $48. TD Cowen analyst Yaron Werber maintained the stock with a Hold and raised the price target from $21 to $29. Considering buying LEGN stock? Here’s what analysts think:
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Biotech dealmaking accelerated heading into the JPM 2026 Healthcare Conference as large drugmakers face looming patent cliffs and hunt for growth. Five therapeutic categories are absorbing most strategic capital: radiopharmaceuticals, next-gen GLP-1, autologous CAR-T, allogeneic cell therapy, and antibody-drug conjugates. Below are the publicly traded category leaders in each. Each is a well-positioned standalone business with M&A optionality, not a takeout prediction.
5. ADC Therapeutics: Pure-Play ADCs ADC Therapeutics (NYSE: ADCT) is one of the few remaining pure-play, commercial-stage ADC names after Pfizer paid $43 billion for Seagen and AbbVie bought ImmunoGen. Lead drug Zynlonta generated $20.03 million in Q1 2026 net product revenue, up 15% year over year, and Q1 revenue of $20.85 million beat the consensus estimate.
The major catalyst is LOTIS-5 Phase 3 topline data expected in Q2 2026, with peak U.S. revenue potential pegged at $600 million to $1 billion and cash runway into 2028. Risks include negative shareholders’ equity of $216.4 million, a Portnoy Law Firm investigation announced in April 2026 over LOTIS-7 safety, and Redmile Group disposing roughly 5.9 million shares in early April 2026. Shares trade near $3.50 apiece.
4. Allogene Therapeutics: Off-the-Shelf CAR-T Allogene Therapeutics (NASDAQ: ALLO) leads the allogeneic CAR-T category that big pharma views as the manufacturing solution to the scalability challenges of patient-specific autologous therapy. The ALPHA3 interim analysis showed 58.3% measurable residual disease (MRD) clearance, versus 16.7% in the observation arm, with no cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease. Q1 EPS met expectations at −$0.18, and an April 2026 raise of $200.4 million (gross) extended the runway into Q1 2029.
The challenge is scale. The market cap is roughly $803.9 million, the stock trades near $2.30, and shares are down 23.9% over the past month after the dilutive offering. Long-dated catalysts (interim EFS mid-2027) keep this in the higher-risk bucket.
3. Legend Biotech: The Autologous Powerhouse Legend Biotech (NASDAQ: LEGN | LEGN Price Prediction) anchors the autologous CAR-T category through its heavyweight partnership with Johnson & Johnson. In recent clinical updates, Carvykti demonstrated a 99% overall response rate (ORR) and 86% complete response/stringent complete response in the CARTITUDE-4 study, with a 94% MRD negativity rate that underscores its “best-in-class” efficacy.
Financial momentum is equally robust: Carvykti generated $597 million in Q1 2026 net trade sales, a 62% year-over-year increase. With a cash position of approximately $1.3 billion and a runway extending through 2026 profitability, Legend has largely de-risked its balance sheet. However, some risks persist, including high operational expenses related to the massive Obelisc manufacturing expansion. Shares are trading for more than $28.00 after a 62.1% rally in the past month, driven by those blowout sales figures and renewed acquisition speculation.
2. Viking Therapeutics: Next-Gen GLP-1 Viking Therapeutics (NASDAQ: VKTX) is the most-named independent in obesity. VK2735 is a dual GLP-1/GIP agonist with VANQUISH-1 fully enrolled (about 4,500 patients) ahead of schedule, and oral VK2735 produced up to 12.2% mean weight reduction at 13 weeks in Phase 2. Phase 2 VENTURE data appeared in the journal Obesity in January 2026.
Polymarket currently prices a 59.5% implied probability of Viking being acquired before 2027, though that figure reflects thin-volume prediction-market sentiment and should be interpreted cautiously. The consensus analyst target stands at $92.33, well above the current share price of approximately $31.50. Risks include a FY2025 net loss of $359.64 million and a Q4 EPS miss of −$1.38 versus the −$0.8958 consensus.
1. Lantheus: Radiopharmaceuticals Lantheus Holdings (NASDAQ: LNTH) tops the list as the only profitable, commercial-scale name beating expectations every quarter. Q1 2026 revenue of $377.33 million exceeded the $354.42 million consensus by 6.46%, and adjusted EPS of $1.46 beat the $1.2292 estimate by 18.78%. Definity grew 6.8%, and Neuraceq added $35.44 million, partially offsetting Pylarify’s 6.5% year-over-year decline.
Management reaffirmed FY2026 revenue guidance of $1.40 billion to $1.45 billion and adjusted EPS of $5.00 to $5.25, and the company secured FDA approval for Pylarify TruVu ahead of a planned Q4 2026 phased launch. CEO Mary Anne Heino said the team is “laying the groundwork for growth acceleration beginning in 2027.” Shares are up 44.9% year to date to around $96.50 and trade at a 23x trailing P/E. The SPECT business sale closed in January 2026, sharpening focus on radiopharma—a space where Novartis has built a franchise around Pluvicto.
A Framework for Retail Investors Buying biotech purely on takeout hopes is a coin flip. The cleaner approach is owning category leaders whose standalone fundamentals justify the position, with M&A optionality as a free call. Lantheus offers the strongest standalone profile; Viking, Legend, Allogene, and ADC Therapeutics carry higher clinical and dilution risk for bigger asymmetric payoffs. Position sizing matters most, because biotech drawdowns can be severe and unforgiving.
First Beijing Investment Ltd disclosed a new position in Legend Biotech (LEGN +4.07%), acquiring 2,296,335 shares in the first quarter, with the estimated trade valued at $43.78 million based on average quarterly pricing, according to a May 13, 2026, SEC filing.
Legend Biotech develops cell therapies for cancer, with a pipeline spanning hematologic malignancies and solid tumors.
Initiated new stake: 2,296,335 shares; estimated trade value $43.78 million (based on quarterly average price)Quarter-end position value at $41.54 million, representing a net valuation change that includes price movementsTrade represented a 1.89% increase in 13F reportable assets under managementPost-trade: 2,296,335 shares held, valued at $41.54 millionPosition accounts for 1.79% of 13F AUM, which places it outside the fund's top five holdingsWhat happenedAccording to an SEC filing dated May 13, 2026, First Beijing Investment Ltd established a new stake in Legend Biotech, purchasing 2,296,335 shares. The estimated transaction value was $43.78 million, calculated using the average closing price for the first quarter. The quarter-end value of this position stood at $41.54 million, reflecting both purchase activity and share price movement during the period.
What else to knowNew position: stake represents 1.79% of 13F reportable assets under management as of March 31, 2026Top holdings after the filing:NASDAQ: PDD: $832.68 million (35.9% of AUM)NYSE: YMM: $747.01 million (32.2% of AUM)NYSE: EDU: $509.40 million (22.0% of AUM)NYSE: RLX: $132.29 million (5.7% of AUM)NASDAQ: KSPI: $32.17 million (1.4% of AUM)As of May 15, 2026, Legend Biotech shares were priced at $27.55, down 0.5% over the prior year, underperforming the S&P 500 by 25.7 percentage pointsCompany OverviewMetricValuePrice (as of market close 2026-05-15)$27.55Market Capitalization$5.08 billionRevenue (TTM)$1.14 billionNet Income (TTM)($250.98 million)Company SnapshotLegend Biotech develops and commercializes novel cell therapies, including its lead CAR-T product candidate for multiple myeloma and a pipeline targeting various hematologic malignancies and solid tumors.The company generates revenue primarily through the development and licensing of its cell therapy portfolio, leveraging strategic collaborations such as its agreement with Janssen Biotech for ciltacabtagene autoleucel.Legend Biotech targets oncology patients, healthcare providers, and pharmaceutical partners in the United States, China, and international markets.Legend Biotech Corporation is a clinical-stage biopharmaceutical company focused on advancing innovative cell therapies for cancer and related diseases. The company leverages proprietary CAR-T technologies and strategic partnerships to address high unmet medical needs in oncology. With a growing portfolio and international presence, Legend Biotech aims to establish a competitive position in the global biotechnology sector.
What this transaction means for investorsFirst Beijing runs a hyper-concentrated book — three names make up roughly 90% of its reported assets, all in Chinese tech and consumer. Adding Legend Biotech at 1.79% of AUM is a toe-dip into a different corner of the China ADR universe, not a conviction call. The stock had already given back meaningful ground before this position was opened, which is worth knowing, but the filing doesn't tell you why First Beijing bought or what their target is. A small new position from a fund this concentrated says less than the same allocation would from a more diversified manager. If you're trying to decide whether Legend Biotech belongs in your portfolio, the CAR-T pipeline and the Janssen partnership are the questions that matter — this 13F just tells you one institution got off the sidelines at a depressed price.
Seena Hassouna has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Joint Stock Kaspi.kz and Legend Biotech. The Motley Fool has a disclosure policy.
Preliminary results from Phase 1 data for LB2102 to reinforce early evidence of activity in solid tumors in a rapid oral presentation New data from the CARTITUDE-4 study to highlight a cytogenetic subgroup analysis of patients who responded to bridging therapy will be featured in a poster presentationCompany to host on-site investor relations event and webcast on Sunday, May 31, at 6:15 p.m. CT
SOMERSET, N.J., May 21, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, today announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, including a rapid oral presentation highlighting preliminary Phase 1 data for LB2102, its investigational DLL3-targeted CAR-T therapy for relapsed or refractory small-cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma (LCNEC).
The Company will also present new data on CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) at ASCO, contributing to the growing body of clinical evidence from the CARTITUDE program that supports its demonstrated efficacy and safety profile in patients with multiple myeloma.
“ASCO provides an important forum to share advancements across our emerging and established CAR-T cell therapy programs,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “The rapid oral presentation for LB2102 underscores continued progress in extending CAR-T approaches into solid tumors, with preliminary data demonstrating a manageable safety profile and early evidence of clinical activity. Additionally, new analyses of CARVYKTI further reinforce the robust clinical profile demonstrated across several studies in multiple myeloma.”
LB2102 represents part of the Company’s broader strategy to expand CAR-T therapies beyond hematologic malignancies and into solid tumors. In November 2023, Legend Biotech’s subsidiary, Legend Biotech Ireland Limited, entered into a license agreement with Novartis Pharma AG (the Novartis Agreement), granting Novartis an exclusive worldwide license to develop, manufacture, and commercialize certain Legend Biotech CAR-T cell therapies targeting DLL3.
Under the Novartis Agreement, Legend Biotech is responsible for conducting the current Phase 1 clinical trial of LB2102 in the United States, while Novartis is responsible for conducting all other development, manufacturing, and commercialization for the licensed products, including LB2102.
In addition to the LB2102 presentation, a subgroup analysis of patients from the CARTITUDE-4 trial who responded to bridging therapy will be presented as a poster. The data highlights the efficacy and safety of patients who received treatment according to their risk level—both high and standard-risk cytogenetics—and achieved a partial response or better after bridging therapy.
Additionally, a separate multi‑study analysis on the incidence and characterization of immune effector cell-associated enterocolitis (IEC-EC) from CARVYKTI® clinical trials will also be presented as a poster.
CARVYKTI® is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI® is now commercially available in 18 countries and has been used to treat more than 10,000 patients to date.
ASCO Presentations (May 29-June 2, 2026)
Abstract No.TitleInformationAbstract #8012
Rapid Oral PresentationPreliminary results from an ongoing Phase 1 study of LB2102, a dnTGFBR2-armored DLL3-targeted autologous CAR-T cell therapy, in patients with relapsed or refractory SCLC or LCNECSession Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Date/Time: Sunday, May 31, 2026, 5:00–5:06 PM CDT
Location: Arie Crown TheaterAbstract #7533
PosterImmune effector cell-associated enterocolitis (IEC-EC) incidence and characterization in cilta-cel-treated patients with RRMM in CARTITUDE clinical studiesSession Title: Hematologic Malignancies—Plasma Cell Dyscrasia
Poster Board: 412
Date/Time: Monday, June 1, 2026, 9:00 AM-12:00 PM CDT
Location: Hall A
Abstract #7536
PosterCiltacabtagene autoleucel in lenalidomide-refractory multiple myeloma responding to bridging therapy: CARTITUDE-4 cytogenetic subgroup analysisSession Title: Hematologic Malignancies—Plasma Cell Dyscrasia
Poster Board: 415
Date/Time: Monday, June 1, 2026, 9:00 AM-12:00 PM CDT
Location: Hall A
Investor Relations Event Details:
Legend Biotech will host an in-person investor relations event on Sunday, May 31, 2026, at 6:15 p.m. CT (7:15 p.m. ET) during the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
The event will feature clinician experts and a discussion about how CARVYKTI® is transforming the multiple myeloma treatment landscape.
Investors and other interested parties may join the live webcast through this weblink or by visiting Legend Biotech’s website under Events and Presentations.
CARVYKTI® IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIESCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI®. Provide supportive care and/or corticosteroids as needed.
Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI®.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI®.
Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®.
Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI®. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®.
WARNINGS AND PRECAUTIONS
INCREASED EARLY MORTALITY – In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).
CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI®.
Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS.
Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
NEUROLOGIC TOXICITIES, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively.
Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (≥2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%).
Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.
Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.
Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson’s disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment.
Guillain-Barré Syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.
Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.
Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.
Peripheral Neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff.
Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.
Cranial Nerve Palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).
The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.
Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.
HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.
Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®.
HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.
PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI® infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.
Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.
INFECTIONS: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI® infusion.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade ≥3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.
Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.
Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.
Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.
HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis.
Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®.
HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.
Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.
IMMUNE EFFECTOR CELL-ASSOCIATED ENTERCOLITIS (IEC-EC) has occurred in patients treated with CARVYKTI®. Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists.
In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting.
SECONDARY MALIGNANCIES: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.
Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.
ADVERSE REACTIONS
The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.
Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®.
ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)
Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single-domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.i
In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.
In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.
ABOUT MULTIPLE MYELOMA
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.ii In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.iii While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems, or infections.iv
ABOUT CARTITUDE-4
CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.v
ABOUT LB2102
NCT05680922 is a Phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells (LB2102) in patients with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.vi
ABOUT SMALL-CELL LUNG CANCER
Lung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.vii Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.viii,ix An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year.16 This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.15,x
ABOUT LEGEND BIOTECH
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X and LinkedIn.
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to: Legend Biotech’s strategies and objectives; the benefits of CARVYKTI, including its emerging curative potential; and the potential of LB2102, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2026. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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i CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
ii American Cancer Society. “What is Multiple Myeloma?”. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html.Accessed March 2024.
iii American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html.Accessed March 2024.
iv American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023.
v ClinicalTrials.Gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024.
vi ClinicalTrials.gov. DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: https://www.clinicaltrials.gov/study/NCT05680922. Accessed May 2025
vii American Cancer Society. “Key Statistics for Lung Cancer.” https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed November 2022.
viii Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121(5):664-72.
ix Rare Diseases. “Rare Disease Database.” https://rarediseases.org/rare-diseases/small-cell-lung-cancer. Accessed November 2022.
x Gong J, Salgia R. Managing patients with relapsed small-cell lung cancer. J Oncol Pract. 2018;14(6):359-66.
