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2026-09-10 05:19 6d ago
2026-09-10 01:02 6d ago
Novavax rozšiřuje Matrix-M prostřednictvím partnerství a onkologie
NVAX Novavax
FMP Stock News 78
Original source text
Analysts Think These Stocks Could More Than Double in ValueNovavax NASDAQ: NVAX outlined its strategy to expand the use of its Matrix-M adjuvant platform through licensing partnerships, internal research programs and commercialization alliances, with management highlighting progress in infectious disease vaccines and early oncology work at the Cantor Healthcare Conference.

Chief Executive Officer John Jacobs said the company has shifted over the past three years from a business centered on commercializing its COVID-19 vaccine to one focused on licensing its technology to larger pharmaceutical partners while maintaining selective internal research and development efforts.

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Is Biotech’s Bull Run Over? Examining Election ImpactsJacobs said Novavax has reduced its expense base by 80% to 90% over that period while retaining key capabilities and establishing a cash runway of more than two years. The company formally launched its updated strategy in January 2025, he said.

Partner activity and Matrix-M platform Jacobs said four of the world’s 10 largest pharmaceutical companies are now working with Novavax, including direct license partners Sanofi and Pfizer, as well as companies operating under material transfer agreements, or MTAs. Under MTAs, partners gain access to Novavax technology for experimentation in their own laboratories.

Moderna Dips on Q2 Earnings But Can It Rip on a Short Squeeze?According to Jacobs, one newly signed top-10 pharmaceutical partner is also a global oncology leader. Across its partnerships, Novavax currently has about 30 distinct areas of exploration spanning infectious diseases, oncology targets, tumor types, viral and bacterial diseases, and vaccine platforms.

Bob Walker, Novavax’s head of research and development, described Matrix-M as a saponin-based adjuvant currently used in two commercially available vaccines: Nuvaxovid, the company’s COVID-19 vaccine, and the R21 malaria vaccine. He said R21 is World Health Organization pre-qualified and has been administered to millions of children in Africa.

Walker said the company has safety and tolerability experience from tens of millions of people who have received Matrix-M-containing vaccines. He also said the adjuvant can be antigen-sparing, allowing a lower dose of antigen while seeking the same immune benefit, which may offer manufacturing and production-cost advantages.

Novavax is evaluating Matrix-M in difficult-to-treat or difficult-to-prevent infectious diseases, including a C. difficile vaccine candidate that Walker said the company is working to advance into the clinic. Jacobs said the candidate could enter the clinic as early as next year.

Oncology research plans Management also emphasized the company’s oncology ambitions. Walker said the research focus is on using Matrix-M to help convert “cold” tumors into tumors that are more accessible to the immune system. He said Matrix-M can activate both antibody responses and cell-mediated T-cell responses, including CD8 cells that play a role in tumor-directed immunity.

Novavax is conducting work in tumor models associated with head and neck cancer, colorectal cancer, pancreatic cancer and melanoma, Walker said. The company is studying Matrix-M used with tumor antigens to induce targeted immune responses. Partners are also conducting preclinical work in their respective areas of investigation.

Walker said Novavax expects to receive both internal and partner-generated preclinical data in the coming months, adding that the company has seen early signs it considers encouraging.

Nuvaxovid commercialization and combination vaccine opportunity Chief Financial Officer Jim Kelly said Sanofi is Novavax’s lead commercialization partner for Nuvaxovid in the United States, Europe, Canada and other major markets, while Takeda remains its partner in Japan. Kelly said Nuvaxovid shipments to U.S. retail locations occurred over the preceding weekend, following late-August approvals that were in line with other COVID-19 vaccines.

Kelly estimated the global COVID-19 vaccine market in 2026 at roughly $5 billion, with an approximately even split between the U.S. and international markets. He said the influenza market is valued at about $5 billion to $6 billion and that a combined COVID-19 and flu market could exceed $10 billion.

Sanofi is promoting Nuvaxovid availability across retail channels and has begun a digital direct-to-consumer program for people seeking a protein-based COVID-19 vaccine option, Kelly said. He added that Sanofi has released data from its COMPARE study, while Novavax previously presented results from the SHIELD-Utah study related to Nuvaxovid tolerability.

Management said Sanofi is in advanced discussions with regulators regarding pivotal Phase III studies for COVID-19 and flu combination products. Kelly said Novavax expects Sanofi to advance late-stage programs, though he noted Novavax does not speak for its partner.

Financial milestones Kelly said Novavax has received $800 million in upfront payments and milestones from its Pfizer and Sanofi agreements over the past three years. The company has stated an objective of reaching non-GAAP profitability as early as 2028, which Kelly said would imply revenue of more than $150 million under its guided cost structure.

He identified $200 million in potential Sanofi-related milestones, including $75 million tied to a Nuvaxovid manufacturing technology transfer that Novavax expects by mid-next year and $125 million upon Sanofi initiating a pivotal Phase III combination-vaccine study in the U.S. or Europe.

Looking ahead a year, Jacobs said Novavax would seek evidence of continued execution by Sanofi and other partners, additional partnerships, growth in Nuvaxovid market share, and proof-of-concept oncology data supporting Matrix-M’s potential role in cancer immunotherapy.

About Novavax (NASDAQ:NVAX)Novavax, Inc is a clinical-stage biotechnology company headquartered in Gaithersburg, Maryland, that specializes in the discovery, development and commercialization of next-generation vaccines to prevent serious infectious diseases. Founded in 1987, the company has built a platform based on recombinant nanoparticle technology and its proprietary Matrix-M™ adjuvant to enhance immune responses.

The company's lead product is NVX-CoV2373, a protein-based vaccine designed to elicit a robust immune response against the SARS-CoV-2 virus.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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2026-08-31 17:12 16d ago
2026-08-31 11:38 16d ago
Novavax roste po schválení vakcíny na klíčových trzích
NVAX Novavax
FMP Stock News 72
Original source text
Shares of Novavax Inc. (NASDAQ:NVAX) are trading higher Monday morning. The stock is extending its 30% monthly gains as investors respond positively to regulatory approvals across major jurisdictions for its updated protein-based COVID-19 vaccine ahead of the 2026–2027 autumn vaccination campaign, alongside broader sector strength bolstered by positive late-stage oncology clinical trial results across the biotech landscape.

Novavax shares are climbing with conviction. Why is NVAX stock surging? Global Regulatory Clearances Validate Licensing Partnership StrategyThe momentum behind Novavax follows regulatory milestones secured late last week when the U.S. FDA granted approval for updated COVID-19 vaccines targeting dominant circulating variants.

Clearances for Novavax’s XFG-adapted Nuvaxovid vaccine alongside commercial partners Sanofi and Takeda ensure timely distribution heading into the fall immunization season.

The approvals could serve as proof of concept for Novavax’s pivoted operating model, which leverages partner infrastructure to maintain steady high-margin licensing royalties without heavy internal commercial overhead.

Competitive Landscape: Landmark Merck-Moderna Phase 3 Cancer Vaccine Milestone The broader vaccine landscape was reshaped in August by major news from Merck & Co and Moderna Inc. The two pharmaceutical giants announced that their Phase 3 INTerpath-001 clinical trial evaluating intismeran autogene (mRNA-4157), a personalized mRNA cancer vaccine, in combination with Keytruda successfully met its primary endpoint.

The combination regimen significantly improved recurrence-free survival and distant metastasis-free survival in patients with high-risk stage III/IV melanoma following surgical resection. The breakthrough late-August trial results validated mRNA technology beyond infectious disease and sparked an August rally in the State Street SPDR S&P Biotech ETF (NYSE:XBI).

Q2 Financial Beat And Executive Focus On Operational EfficiencyThe regulatory tailwinds build on Novavax’s second-quarter earnings delivered on August 6. Second-quarter revenue reached $415 million, driven by strategic milestone payments and cost-reduction initiatives, helping narrow operating losses and bolster the cash position.

During Novavax’s second-quarter earnings call, President and Chief Executive Officer John C. Jacobs emphasized the structural transformation of the business:

"Our second-quarter performance underscores the strength of our lean operating model and strategic partnerships. By combining our protein-based technology with commercial leaders like Sanofi, we are expanding global patient access while maintaining strict cost discipline and generating durable value across our broader pipeline."

NVAX Price Action: Novavax shares were up 4.10% at $9.64 at the time of publication on Monday, according to Benzinga Pro data.

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2026-08-06 15:41 1mo ago
2026-08-06 10:51 1mo ago
Novavax ve 2. čtvrtletí snížil ztrátu a překonal odhady tržeb
NVAX Novavax
FMP Stock News 78
Original source text
Novavax (NVAX - Free Report) came out with a quarterly loss of $0.32 per share versus the Zacks Consensus Estimate of a loss of $0.36. This compares to earnings of $0.62 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +11.11%. A quarter ago, it was expected that this vaccine maker would post a loss of $0.25 per share when it actually produced a loss of $0.06, delivering a surprise of +76%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Novavax, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $56.7 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 13.31%. This compares to year-ago revenues of $239.24 million. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Novavax shares have added about 14.6% since the beginning of the year versus the S&P 500's gain of 12.8%.

What's Next for Novavax?While Novavax has outperformed 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 Novavax was favorable. 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 #1 (Strong Buy) for the stock. So, the shares are expected to outperform 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 -$0.01 on $106.06 million in revenues for the coming quarter and -$0.19 on $371.85 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, Medical - Biomedical and Genetics is currently in the top 44% 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, BioStem Technologies, Inc. (BSEM - Free Report) , is yet to report results for the quarter ended June 2026. The results are expected to be released on August 12.

This company is expected to post quarterly loss of $0.50 per share in its upcoming report, which represents a year-over-year change of -554.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

BioStem Technologies, Inc.'s revenues are expected to be $6.4 million, down 87% from the year-ago quarter.
2026-08-06 13:15 1mo ago
2026-08-06 08:00 1mo ago
Novavax zvýšil celoroční výhled tržeb a snížil náklady
NVAX Novavax
FMP Stock News 92
Original source text
Reported total revenue of $57 million for the second quarter of 2026 and raised full-year 2026 Revenue Framework Improved GAAP Combined R&D and SG&A expense guidance by $10 million at mid-point  Sanofi confirmed with Novavax that they are in advanced discussions with regulators regarding their Phase 3 COVID-19-Influenza Combination trial timing and intend to be among the first movers in the combination vaccine segment Completion of manufacturing technology transfer to Sanofi expected in mid-2027 and would trigger a $75 million milestone payment to Novavax Multiple partner-led experiments with Matrix-M are currently underway in a wide array of infectious disease and oncology targets On track to advance C. difficile vaccine program into the clinic as early as 2027 , /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for the second quarter ended June 30, 2026.

"We're encouraged by the momentum we're seeing across our business as we continue to advance our strategy," said John C. Jacobs, President and Chief Executive Officer, Novavax. "As we enter the second half of 2026 and prepare for next year, we believe we are well positioned to deliver several important partner milestones while we advance our internal R&D programs and progress our MTA collaborations. This continued progress reinforces our confidence in our strategy and the potential to drive vaccine innovation to create meaningful value for our shareholders."

Second Quarter 2026 and Recent Highlights

Key Business Highlights

Sanofi partnership continues to advance, supporting significant potential near- and long-term value creation. Sanofi confirmed with Novavax they intend to be among the first movers in the combination vaccine segment and that they are in advanced discussions with regulators regarding their Phase 3 COVID-19-Influenza Combination (CIC) trial timing. Initiation of this trial in the U.S. or European Union will trigger a $125 million milestone to Novavax. Manufacturing technology transfer to Sanofi for Nuvaxovid™ is expected to be completed in mid-2027, which would trigger a $75 million milestone payment to Novavax. Sanofi is expanding the commercial reach of Nuvaxovid through broader commercial activities in the U.S. and launches in the United Kingdom, Germany and Canada from 2026 onwards, with Novavax eligible to receive royalties in the high teens to low twenties as a percentage of Sanofi's global net sales. Sanofi received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its H5 pandemic influenza vaccine candidate (SP0335) utilizing Matrix-M®. A growing body of scientific evidence supports Matrix-M's utility in oncology and infectious disease. Multiple scientific evaluations by partners and potential partners are underway, enabling future licensing opportunities. Advanced Novavax's differentiated C. difficile vaccine candidate into pre-IND interactions with the FDA and initiated GMP manufacturing process, supporting potential clinical entry as early as 2027. Second Quarter 2026 Total Revenue

$ in millions

Q2 2026

Q2 2025

Change

%

Nuvaxovid Sales 1

$          0

$          (2)

$            2

N/A

Supply Sales 2

19

13

6

47 %

Product Sales

19

11

8

76 %

Sanofi 3

36

199

(164)

(82 %)

Takeda

0

27

(27)

(99 %)

Serum

2

2

0

N/A

Licensing, Royalties
and Other Revenue

38

229

(191)

(83 %)

Total Revenue

$        57

$       239

$       (183)

(76 %)

Notes

1.

Nuvaxovid Sales reflects product sales where Novavax is the commercial market lead and records revenue related to the sales and distribution of its COVID-19 vaccine.

2.

Supply Sales includes sales of finished product, adjuvant and other supplies from Novavax to its license partners.

3.

Sanofi includes revenue recognized under the license agreement including upfront payments, milestones, royalties and transition services reimbursement.

Second Quarter 2026 Financial Results

Total revenue for the second quarter of 2026 was $57 million, a 76% decrease compared to $239 million in the same period in 2025. The prior year's second quarter 2025 total revenue included the benefit of $202 million from the combination of a $175 million milestone earned for the Nuvaxovid U.S. Biologics License Application (BLA) approval and a $27 million Takeda amendment. Product sales of $19 million in the second quarter of 2026 were 76% higher than the same period in 2025 due to higher Matrix-M adjuvant demand and sales to license partners. Cost of sales for the second quarter of 2026 were $14 million, compared to $15 million in the same period in 2025.
  Research and development (R&D) expenses for the second quarter of 2026 were $71 million, compared to $79 million in the same period in 2025. R&D expenses reimbursed by partners in the second quarter of 2026 were $23 million. Non-GAAP R&D expenses, net of partner reimbursement, were $48 million in the second quarter of 2026, a 34% decrease when compared to $73 million in the same period in 2025. The lower Non-GAAP R&D expenses were driven by the ongoing Novavax cost reduction program as it streamlines operations and makes targeted R&D investments. Selling, general and administrative expenses (SG&A) expenses for the second quarter of 2026 were $27 million, a 39% decrease compared to $44 million for the same period in 2025. The decrease was primarily due to the transition of lead commercial activities to Sanofi and the elimination of commercial infrastructure plus the ongoing general administrative cost reduction program.  Net loss for the second quarter of 2026 was $53 million, compared to net income of $107 million in the same period in 2025. The prior years, second quarter of 2025 net income benefited from $202 million from a combination of a $175 million milestone earned for the Nuvaxovid U.S. BLA approval and a $27 million Takeda amendment. Cash, cash equivalents, marketable securities and restricted cash (Cash) were $724 million as of June 30, 2026, compared to $751 million as of December 31, 2025. Financial Framework

Improves Full Year 2026 Financial Guidance

Novavax improved its Full Year 2026 Financial Guidance by reducing Combined R&D and SG&A Expense guidance while maintaining Non-GAAP Combined R&D and SG&A Expense guidance and expects to achieve the following results:

$ in millions

Full Year 2026

(as of Aug 6, 2026)

Full Year 2026

(as of May 6, 2026)

Combined R&D and SG&A
Expenses

$370 - $410

$380 - $420

Less: R&D Reimbursements

($60 - $70)

($70 - $80)

Non-GAAP Combined R&D and
SG&A Expenses

$310 - $340

$310 - $340

Non-GAAP Combined R&D and SG&A Expenses exclude R&D Reimbursements, which are amounts reimbursed by Novavax's license partners. See "Non-GAAP Financial Measures" below. R&D Reimbursements are recorded as revenue under Licensing, Royalties and Other Revenue. 

Raises Full Year 2026 Revenue Framework

For 2026, Novavax raised its 2026 Revenue Framework and expects to achieve Adjusted Total Revenue4 to between $235 million and $275 million. Novavax transitioned lead commercial responsibility of Nuvaxovid beginning with the 2025-2026 COVID-19 vaccination season to Sanofi for select markets. Since Novavax is reliant on Sanofi's sales forecasts for certain revenue components, these are not included in the Full Year 2026 Revenue Framework.

$ in millions

Full Year 2026

(as of Aug 6, 2026)

Full Year 2026

(as of May 6, 2026)

Nuvaxovid Product Sales1

$35 - $45

$35 - $45

Adjusted Supply Sales2

$45 - $55

$40 - $50

Adjusted Licensing, Royalties and
Other Revenue3

$155 - $175

$155 - $175

Adjusted Total Revenue4

$235 - $275

$230 - $270

Sanofi Supply Sales, Sanofi Royalties
and Sanofi Milestones

No guidance

No guidance

Revenue Framework Footnotes

Revenue Category

Revenue Framework Footnotes

Nuvaxovid Product
Sales1

$35 million to $45 million in Nuvaxovid Product Sales by Novavax
under existing Advance Purchase Agreements and commercial
agreements. 

Adjusted Supply
Sales2

$45 million to $55 million in Adjusted Supply Sales associated with
collaborations with the Serum Institute on R21/Matrix-M™ and
collaboration partners for COVID-19 vaccine, including Serum and
Takeda and other partner related clinical and commercial supply
sales. 

Adjusted Licensing,
Royalties and Other
Revenue3 



$60 million to $70 million in R&D Reimbursement. Under the
Sanofi co-exclusive licensing agreement, Novavax is eligible to
receive reimbursement for costs incurred related to select R&D
and technology transfer activities during the transition
performance period.



$60 million to $70 million in Other Partner related revenue
including royalties and milestones from Pfizer, Serum on
R21/Matrix-M and collaboration partners for COVID-19 vaccine,
including Serum and Takeda. Includes a $30 million upfront
payment under the Pfizer agreement received in the first quarter
of 2026.



$35 million amortization related to the $500 million Upfront
Payment and the $50 million Database Lock Milestone. Revenue
recognition will occur over the transition performance period.

Adjusted Total
Revenue4



Adjusted Total Revenue is a Non-GAAP Financial Measure.
Adjusted Total Revenue is total revenue excluding Sanofi Supply
Sales, Sanofi Royalties and Sanofi Milestones. See "Non-GAAP
Financial Measures."

Components of Revenue excluded from the Full Year 2026 Revenue Framework are described below. 

Sanofi Supply Sales

Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2026-2027 COVID-19 vaccination season and the reimbursement for this supply will be recorded as product sales. Sanofi Royalties

Sanofi will lead commercial activities for the 2026-2027 COVID-19 vaccination season in select markets, including the U.S. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi global net sales. Sanofi Milestones

Novavax is eligible to receive up to $350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi CIC products. For each new vaccine using Matrix-M, Novavax is eligible to receive up to $200 million in launch and sales milestones and mid-single digit sales royalties for 20 years. Conference Call
Novavax will discuss second quarter 2026 financial results and operational highlights at 8:30 a.m. Eastern Time on Thursday, August 6, 2026. Dial-in information can be found here. A webcast of the conference call can also be accessed on the Novavax website at ir.novavax.com/events.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including its Matrix-M adjuvant and protein-based nanoparticles. The Company's corporate growth strategy is designed to deliver value via three key strategic pillars: partnering its technology, targeted and capital-efficient R&D innovation and a lean and efficient operating model. This includes maximizing impact through partnerships for its marketed products (Nuvaxovid, R21/Matrix-M), Matrix technology and R&D assets. Please visit novavax.com and LinkedIn for more information.

Non-GAAP Financial Measures
The Company presents the following non-GAAP financial measures in this press release: Non-GAAP Combined R&D and SG&A Expenses, Adjusted Total Revenue and Adjusted Licensing, Royalties and Other Revenue. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in the United States (GAAP). The Company believes that the presentation of these adjusted financial measures is useful to investors as they provide additional information on comparisons between periods by including certain items that affect overall comparability. The Company uses these non-GAAP financial measures for business planning purposes and to consider underlying trends of its business. Non-GAAP financial measures should be considered in addition to, and not as an alternative for, the Company's reported results prepared in accordance with GAAP. Our use of non-GAAP financial measures may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. The Company is unable to reconcile these revenue forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable effort because the Company is reliant on Sanofi sales forecasts for certain revenue categories, which are not available.

Forward-Looking Statements
This press release contains forward-looking statements relating to the future of Novavax, its mission; its corporate strategy and operating plans, objectives and prospects; its value drivers and strategic priorities; its partnerships, including expectations with respect to potential partner product sales and royalties, milestones and other commercial objectives, and cost reimbursement, Matrix-M's potential utility in partners' vaccine portfolios and plans for additional potential partnering activities; the development of Novavax's clinical and preclinical product candidates and pipeline advancement opportunities the conduct, timing and potential results from clinical trials, conducted by Novavax or its partners, ; expectations as to the timing and outcome of future and pending regulatory filings and actions; full year 2026 financial guidance and revenue framework; and Novavax's future financial or business performance. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, Novavax's ability to successfully and timely obtain and maintain full U.S. FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver its COVID-19 vaccine; the impact of delays in obtaining regulatory approval, including regulatory decisions impacting labeling, approval or authorization, including the scope of the indicated population, product dosage, manufacturing processes, shelf life, safety, for our product candidates; challenges in conducting the PMC study, our ability to obtain adequate additional funding to maintain our current level of operations and fund the further development of our vaccine candidates; challenges related to Novavax's partnership with Sanofi, including collaboration on the Nuvaxovid PMC, and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; the impact of potential legislative, regulatory, or policy changes under the current presidential administration, including any adverse impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance; uncertainty with respect to pricing, third-party reimbursement and healthcare reform; uncertainty in the regulatory pathway for Novavax's COVID -19 Vaccine; the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions; Novavax's ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of its COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidates, stand-alone influenza vaccine candidates or other candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

NOVAVAX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share information)

Three Months Ended

Six Months Ended

June 30,

June 30,

2026

2025

2026

2025

(unaudited)

(unaudited)

Revenue:

   Product sales

$        18,854

$       10,724

$           61,054

$      632,402

   Licensing, royalties and other

37,844

228,516

135,158

273,493

Total revenue

56,698

239,240

196,212

905,895

Expenses:

   Cost of sales

14,246

15,325

44,941

29,439

   Research and development

70,693

79,233

166,165

168,170

   Selling, general and administrative

26,665

43,612

55,442

91,702

Total expenses

111,604

138,170

266,548

289,311

Income (loss) from operations

(54,906)

101,070

(70,336)

616,584

Other income (expense):

   Interest expense

(5,689)

(5,518)

(10,590)

(11,241)

   Other income, net

8,919

11,902

20,744

21,957

Income (loss) before income tax expense

(51,676)

107,454

(60,182)

627,300

   Income tax expense

1,711

946

2,696

2,146

Net income (loss)

$       (53,387)

$     106,508

$         (62,878)

$      625,154

Net income (loss) per share:

  Basic

$           (0.32)

$           0.66

$             (0.38)

$            3.87

  Diluted

$           (0.32)

$           0.62

$             (0.38)

$            3.55

Weighted average number of common shares outstanding:

  Basic

164,574

162,019

163,929

161,536

  Diluted

164,574

177,215

163,929

177,410

SELECTED CONSOLIDATED BALANCE SHEET DATA

(in thousands)

June 30, 2026

December 31, 2025

(unaudited)

Cash and cash equivalents

$                  191,458

$                  240,634

Marketable securities

527,882

494,450

Total restricted cash

4,582

15,418

Total current assets

771,098

978,276

Working capital

440,524

518,326

Total assets

955,575

1,176,512

Long-term debt

291,490

244,213

Total stockholders' deficit

(190,707)

(127,753)

NOVAVAX, INC.

Reconciliation of GAAP to NON-GAAP Financial Results

(unaudited)

Three Months Ended

Six Months Ended

($ in millions)

June 30,

June 30,

2026

2025

2026

2025

R&D Expenses

$70.7

$79.2

$166.2

$168.2

Adjustments:

R&D Reimbursement

22.6

6.5

50.3

17.7

Non-GAAP R&D Expenses

$48.1

$72.8

$115.9

$150.4

Combined R&D and SG&A Expenses

$97.4

$122.8

$221.6

$259.9

Adjustments:

R&D Reimbursement

22.6

6.5

50.3

17.7

Non-GAAP Combined R&D and SG&A
Expenses

$74.8

$116.4

$171.3

$242.1

Contacts:

Investors
Naina Zaman
240-410-5353
[email protected]

Media

Yvonne Sprow
844-264-8571
[email protected]

SOURCE Novavax, Inc.
2026-07-28 23:51 1mo ago
2026-07-28 18:45 1mo ago
Novavax klesá před výsledky, trh očekává ztrátu EPS
NVAX Novavax
FMP Stock News 72
Original source text
Novavax (NVAX - Free Report) closed at $7.37 in the latest trading session, marking a -1.6% move from the prior day. This move lagged the S&P 500's daily gain of 0.21%. Meanwhile, the Dow experienced a rise of 1.03%, and the technology-dominated Nasdaq saw a decrease of 0.22%.

The stock of vaccine maker has fallen by 19.98% in the past month, lagging the Medical sector's loss of 0.43% and the S&P 500's gain of 1.7%.

The upcoming earnings release of Novavax will be of great interest to investors. The company is predicted to post an EPS of -$0.36, indicating a 158.06% decline compared to the equivalent quarter last year. Meanwhile, the Zacks Consensus Estimate for revenue is projecting net sales of $50.04 million, down 79.08% from the year-ago period.

For the annual period, the Zacks Consensus Estimates anticipate earnings of -$0.19 per share and a revenue of $371.85 million, signifying shifts of -107.36% and -66.9%, respectively, from the last year.

Investors should also take note of any recent adjustments to analyst estimates for Novavax. Such recent modifications usually signify the changing landscape of near-term business trends. As a result, upbeat changes in estimates indicate analysts' favorable outlook on the business health and profitability.

Based on our research, we believe these estimate revisions are directly related to near-term stock moves. To benefit from this, we have developed the Zacks Rank, a proprietary model which takes these estimate changes into account and provides an actionable rating system.

Ranging from #1 (Strong Buy) to #5 (Strong Sell), the Zacks Rank system has a proven, outside-audited track record of outperformance, with #1 stocks returning an average of +25% annually since 1988. Over the past month, the Zacks Consensus EPS estimate has remained steady. Novavax is currently sporting a Zacks Rank of #1 (Strong Buy).

The Medical - Biomedical and Genetics industry is part of the Medical sector. This industry, currently bearing a Zacks Industry Rank of 92, finds itself in the top 38% echelons of all 250+ industries.

The Zacks Industry Rank is ordered from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.

Make sure to utilize Zacks.com to follow all of these stock-moving metrics, and more, in the coming trading sessions.