SNY

It has been about a month since the last earnings report for Kymera Therapeutics, Inc. (KYMR). Shares have added about 10.2% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Kymera Therapeutics due for a pullback? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent catalysts for Kymera Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. KYMR Q2 Earnings and Revenues Top Estimates on Gilead, Sanofi Payments Kymera Therapeutics reported a second-quarter 2026 loss of 62 cents per share, narrower than the Zacks Consensus Estimate of a loss of 64 cents. The company posted a loss of 95 cents per share in the year-ago period. Revenues surged to $65 million from $11.5 million in the year-ago quarter and surpassed the Zacks Consensus Estimate of $39 million. KYMR's Collaboration Revenues Drive Top-Line Growth All second-quarter revenues came from collaboration agreements. Kymera recognized a $45 million option exercise fee related to Gilead Sciences, Inc.’s exclusive license for KT-200, its oral CDK2 molecular glue degrader candidate. The company also recorded a $20 million milestone payment after Sanofi initiated a phase I study of KT-485, an oral, potent and selective second generation IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa patients. Management said all deferred revenues have now been recognized. Consequently, Kymera does not expect additional revenues in 2026. Future collaboration revenues will depend on milestones achieved under the Gilead or Sanofi agreements in 2027 and beyond. Kymera's R&D Spending Rises With Clinical Activity Research and development expenses increased 52.4% year over year to $119.48 million. The increase reflected higher investments in the STAT6 program, platform and discovery programs, along with continued expansion of the R&D organization. R&D expenses included $10.4 million of stock-based compensation. Excluding that noncash expense, adjusted cash R&D spending was $109.1 million. General and administrative expenses rose 19.7% to $21.13 million. The increase was driven by higher legal and professional service costs, personnel expenses and facility-related spending. Kymera Maintains Cash Runway Into 2029 Cash, cash equivalents and marketable securities totaled $1.50 billion as of June 30, 2026, compared with $1.62 billion at the end of 2025. Management maintained its expectation that available capital will be sufficient to fund operations through 2029. The runway is expected to support completion of KT-621’s phase IIb studies in atopic dermatitis and asthma, as well as KT-579’s planned lupus proof-of-concept program. Kymera also expects to fund the initial stages of a phase III asthma study and most of the planned phase III atopic dermatitis study for KT-621. Kymera Accelerates KT-621 Development Timeline KT-621, an investigational once-daily oral STAT6 degrader, is being developed for type II inflammatory diseases. Kymera completed enrollment in the BROADEN2 phase IIb study of KT-621 in moderate-to-severe atopic dermatitis (AD) nearly six months ahead of schedule. Top-line data are now expected by year-end 2026, six months earlier than the company’s previous target. Subject to regulatory discussions, phase III studies in atopic dermatitis are planned to begin by mid-2027. The trial is evaluating three doses of the once-daily oral STAT6 degrader against placebo. Its primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index score at week 16. Enrollment is also underway in the BREADTH phase IIb study in patients with moderate-to-severe eosinophilic asthma. Kymera continues to expect top-line data in late 2027 and has initiated an open-label extension that permits eligible participants to receive KT-621 for up to 52 additional weeks. KYMR Advances IRF5 and Partnered Programs Beyond STAT6, Kymera is progressing KT-579, a first-in-class oral degrader of IRF5, a transcription factor positioned as a master regulator across autoimmune diseases. Enrollment is ongoing in the phase I study of KT-579 in healthy volunteers, with data expected in the fourth quarter of 2026. The study is assessing whether the oral IRF5 degrader can achieve more than 90% degradation in blood while maintaining a favorable safety profile. Kymera plans to initiate a proof-of-concept study in lupus patients soon after completing the healthy-volunteer trial. Update on KYMR’s Partnered Programs Sanofi initiated the first-in-human phase I study evaluating KT-485 (SAR447971) in adult healthy volunteers and hidradenitis suppurativa patients. KT-485 has the potential to offer a novel oral approach for a variety of chronic immuno-inflammatory diseases.  Under the agreement, Sanofi is responsible for the program's development, regulatory and commercialization activities. In April 2026, Gilead Sciences exercised its option to exclusively license KT-200, Kymera's first-in-class oral CDK2 molecular glue degrader, triggering a $45 million milestone payment. KT-200 is being developed for breast cancer and other solid tumors and has the potential to improve the current standard of care. Gilead plans to advance the candidate into IND-enabling studies, with an IND filing targeted for 2027. It turns out, estimates revision have trended downward during the past month. The consensus estimate has shifted -24.69% due to these changes. At this time, Kymera Therapeutics has a poor Growth Score of F, a grade with the same score on the momentum front. Following the exact same course, the stock has a score of F on the value side, putting it in the lowest quintile for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Kymera Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Kymera Therapeutics belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, TG Therapeutics (TGTX), has gained 14.5% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. TG Therapeutics reported revenues of $240.34 million in the last reported quarter, representing a year-over-year change of +70.3%. EPS of $0.05 for the same period compares with $0.17 a year ago. TG Therapeutics is expected to post earnings of $0.36 per share for the current quarter, representing a year-over-year change of -85.2%. Over the last 30 days, the Zacks Consensus Estimate has changed +9.9%. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for TG Therapeutics. Also, the stock has a VGM Score of F. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kymera Therapeutics, Inc. (KYMR) : Free Stock Analysis Report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Novartis stock climbed after the Swiss drugmaker announced positive results Tuesday from two late-stage trials of its oral multiple sclerosis drug remibrutinib, raising expectations that the medicine could become a major revenue driver. By Tuesday's European midday session, Novartis shares had gained 4.5%, pushing the stock's gain for the year to 18%, according to the Wall Street Journal. The two Phase III studies, called REMODEL-1 and REMODEL-2, each enrolled approximately 1,000 patients with relapsing multiple sclerosis and compared remibrutinib against teriflunomide, sold by Sanofi under the brand name Aubagio. Both trials met their primary endpoint, reducing the annualized relapse rate, and showed superiority over teriflunomide across all key secondary endpoints, including a reduction in MRI brain lesions, the company said. The drug also produced clinically meaningful results in slowing disability progression. Novartis said remibrutinib showed no liver safety signal across more than 4,500 clinical trial participants in multiple indications, with no cases meeting Hy's Law criteria. Other medicines in the BTK inhibitor category — which stands for Bruton's tyrosine kinase — have run into trouble with regulators because of liver-toxicity findings, according to Reuters. In December, the U.S. Food and Drug Administration declined to approve Sanofi's tolebrutinib after that drug failed to show superiority to Aubagio in preventing relapses. UBS analyst Matt Weston told clients that "remi looks like it is at least a best-in-class oral agent." Weston added that remibrutinib's pairing of robust relapse control with a cleaner liver-safety record made it "a no-brainer" compared with competing drugs. Reuters reported that two patients died during the trials, with investigators determining the deaths were unconnected to the study drug. Analysts said they would be looking for more detailed safety data. The company intends to pursue regulatory approval for remibrutinib in relapsing multiple sclerosis across major markets, with complete trial data to be shared at an upcoming medical conference in Toronto. "Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile," said Shreeram Aradhye, Novartis's chief medical officer, in the company's announcement. Remibrutinib is already approved in the U.S. and the European Union under the brand name Rhapsido for the skin condition chronic spontaneous urticaria. The company has identified remibrutinib as a key pipeline asset as it works to offset revenue lost when blockbuster heart drug Entresto faced generic competition. Multiple sclerosis drug Kesimpta grew 32% to $1.42 billion in the second quarter, underscoring the commercial potential of the MS franchise. Among a trio of high-profile Novartis development programs expected to produce readouts this year, the REMODEL trials represent the first positive outcome. The company is also awaiting results from studies of heart drug pelacarsen and gene therapy del-desiran.

Initiated the first-in-human Phase 1 trial of STX-1150, a novel LDL-C lowering therapy powered by ELXR, a highly engineered epigenetic silencing technology designed to deliver ultra-long-acting cholesterol lowering without permanent genetic changes Awarded more than $25 million from the California Institute for Regenerative Medicine (CIRM) to advance both STX-1200 for Lp(a) lowering and STX-1400 for triglyceride lowering toward clinical entry Completed upsized initial public offering, including full exercise of the underwriters’ purchase option, and a concurrent private placement to Sanofi, generating approximately $155.5 million in aggregate gross proceeds Cash, cash equivalents, and marketable securities of $43.0 million as of June 30, 2026, plus approximately $140.6 million of net proceeds raised from the July 2026 IPO and concurrent private placement, provides funding into the first half of 2029 ALAMEDA, Calif., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Scribe Therapeutics Inc. (“Scribe Therapeutics” or “the Company”) (Nasdaq: SCTX), a clinical-stage biotechnology company engineering purpose-built in vivo CRISPR technologies designed to extend healthy lifespan through disease prevention and durable therapeutic intervention, today reported financial results for the second quarter ended June 30, 2026, and provided recent corporate and pipeline updates. “The second quarter and the weeks immediately following represented a transformational period for Scribe,” said Benjamin Oakes, Ph.D., co-founder and Chief Executive Officer of Scribe Therapeutics. “We advanced our lead silencing asset STX-1150 into the clinic, secured significant grant support from CIRM to develop our next two cardiometabolic assets, and successfully completed our initial public offering. These achievements position us to execute across a broadly differentiated portfolio of CRISPR genetic medicines designed to address the three major lipid drivers of atherosclerotic cardiovascular disease: LDL-C, Lp(a), and triglycerides. Our purpose-built technologies are uniquely poised to democratize access to the cardioprotective effects of beneficial human genetics. Guided by nature's blueprint for improved cardiovascular health, our aim is to shift the treatment paradigm of heart disease from chronic intervention of symptoms toward durable disease prevention and lifespan extension.” Pipeline Highlights STX-1150: In vivo epigenetic silencing therapy for LDL-C lowering Initiated first-in-human Phase 1 clinical trial in Australia for Scribe’s epigenetic silencing therapy STX-1150. Presented late-breaking data at the European Atherosclerosis Society (EAS) Congress supporting STX-1150 for persistent LDL-C lowering after a single dose. Epigenetic silencing with STX-1150 is designed to address a major limitation of current LDL-C lowering approaches and is positioned to recapitulate the cardioprotective effects of human genetics. Clinical data expected in the first half of 2027. STX-1200 and STX-1400: Advancing cardiometabolic gene editing programs targeting genetically driven, severely elevated Lp(a) and triglycerides, respectively. Awarded approximately $25.7 million in combined non-dilutive CIRM grants. Awarded $12.7 million for advancing STX-1200 toward clinical entry as early as 2027. Awarded $13.0 million for advancing STX-1400 toward clinical entry as early as 2027. Platform and Scientific Leadership Published updated findings in bioRxiv, highlighting the ELXR platform's novel enhancements in potency and safety enabling the durable repression of target genes without permanent DNA modification. The publication illustrates a novel framework for engineering context-aware epigenetic therapies. Further demonstrated that these engineering approaches developed molecules that decrease off-targets by up to 10x and increase on-target activity across loci as much as 4x. To the Company's knowledge, this is the first example of an epigenetic therapy with an allosterically gated sequential proofreading mechanism that meaningfully widens the therapeutic window of CRISPR approaches. Corporate Highlights Nasdaq listing. Common stock began trading on the Nasdaq Global Market on July 24, 2026, under the ticker symbol “SCTX.” Scribe upsized its initial public offering and priced at the high end of the range at $15.00 per share. The Company also completed a concurrent private placement to Sanofi at the IPO price. Approximately $155.5 million in aggregate gross proceeds. Capital raised from the IPO, the full exercise of the underwriters’ option, and the concurrent private placement totaled $155.5 million before underwriting discounts, commissions, and offering expenses. Funding into the first half of 2029. Based on Scribe’s current operating plan, the Company believes its existing cash, cash equivalents, and investments, together with net proceeds from the IPO and the concurrent private placement, will be sufficient to fund its operating expenses and capital expenditure requirements into the first half of 2029. Second Quarter 2026 Financial Results Cash position: Cash, cash equivalents, and marketable securities were $43.0 million as of June 30, 2026, compared with $58.0 million as of December 31, 2025. Cash, cash equivalents, and marketable securities of $43.0 million as of June 30, 2026, plus approximately $140.6 million of net proceeds raised from the July 2026 IPO and concurrent private placement, provides funding into the first half of 2029. Collaboration revenue: Collaboration revenue was $1.9 million for the three months ended June 30, 2026, compared with $4.9 million for the prior year period in 2025. The decrease was primarily attributable to lower reimbursable research and development activities and reduced revenue recognition under the Company's collaboration arrangements. Research and development expenses: Research and development expenses were $8.8 million for the three months ended June 30, 2026, compared with $13.9 million for the prior year period in 2025. The decrease was primarily attributable to lower personnel-related costs and reduced spending on preclinical research programs, partially offset by increased expenditures supporting the advancement of the STX-1150 Phase 1 clinical trial, including clinical and manufacturing activities. General and administrative expenses: General and administrative expenses were $2.5 million for the second quarter of 2026, compared with $2.6 million for the second quarter of 2025. The decrease was primarily attributable to lower administrative costs. Net loss: Net loss was $6.5 million, or $2.62 per basic and diluted share, for the three months ended June 30, 2026, compared with a net loss of $9.9 million, or $4.08 per basic and diluted share, for the same period in 2025. About Scribe Therapeutics Inc.Scribe Therapeutics is a clinical-stage biotechnology company engineering CRISPR-based technologies into purpose-built in vivo genetic medicines designed to become standard of care treatments for patients suffering from highly prevalent diseases, starting with cardiometabolic disease. Leveraging its CRISPR by Design™ approach and nature’s blueprint for improved cardiovascular health, Scribe’s initial programs focus on addressing the key drivers of ASCVD such as elevated LDL-C, lipoprotein(a), and triglycerides. The company’s lead candidate, STX-1150, is a novel liver-targeted therapy designed to epigenetically silence the PCSK9 gene and reduce LDL-C levels without inducing permanent DNA changes. To broaden and accelerate the impact of its engineered CRISPR technologies for patients, Scribe has formed strategic collaborations with world-leading pharmaceutical companies including Sanofi and Eli Lilly. Co-founded by Nobel Prize winner Jennifer Doudna and backed by leading life sciences investors, Scribe is advancing scalable, transformative, and preventative genetic medicines with the goal of improving outcomes and democratizing access to the protective effects of beneficial human genetics. To learn more, visit www.scribetx.com. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this press release, including statements regarding Scribe’s strategy, business plans and objectives; the therapeutic potential, safety, efficacy, durability, scalability and clinical or commercial prospects of Scribe’s product candidates and technologies; the design, initiation, enrollment, conduct, timing and results of preclinical studies and clinical trials; the timing of clinical data and other anticipated milestones; the advancement of STX-1150, STX-1200, STX-1400 and other programs; the expected use and benefits of CIRM funding; and Scribe’s expected cash runway and financial position are forward-looking statements. The words “aim,” “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “seek,” “should,” “target,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are based on management’s current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those described under the heading “Risk Factors” in Scribe’s filings with the U.S. Securities and Exchange Commission, including its final prospectus filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, and future reports that Scribe may file with the SEC. Except as required by law, Scribe undertakes no obligation to update any forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events. Investor Contact:Investor Relations, Scribe [email protected] Media Contact:Thermal for Scribe [email protected]

For income investors, there's a solid stock that pays a handsome dividend and, due to a recent decline in its share price, is trading at a bargain-basement price. I'm talking about Sanofi (NASDAQ: SNY), the French multinational pharmaceutical that is focused on immunology, vaccines, and rare diseases. The stock pays a $0.61 quarterly dividend, yielding about 5.4% (the annual dividend divided by the share price). That's a handsome yield by any measure. And when you factor in the impact of the company's stock buybacks, that yield rises to near 11%. And the company has raised its dividend for 30 consecutive years, making it a member of the European Dividend Aristocrats® (a registered trademark of Standard & Poor's Financial Services LLC). Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue » And yet, Sanofi's share price is down about 6.5% this year. Part of that is because the drugmaker canceled several major late-stage programs, raising valid investor concerns about its drug pipeline. Does that spell opportunity now for investors? Let's see. But the company recently posted strong second-quarter results. It earned $1.22 a share on revenue of $13.48 billion, both of which beat analysts' expectations. And sales of its blockbuster immunology drug, Dupixent, climbed 38% to 5.15 billion euros, surpassing 5 billion euros in a quarter for the first time. But investors considering Sanofi's shares need to look forward, not back. And the company just got some very good news: In July, the U.S. Food and Drug Administration (FDA) approved the company's on-body injector for isatuximab, sold under the brand name Sarclisa, which treats multiple myeloma, a type of bone marrow and blood cancer. As a result, the stock has rebounded in recent weeks and is up about 6% so far in August. Wall Street thinks it can continue to climb. The average analyst price target for the stock is $53.72, representing a nearly 18% gain from the current share price. Of the 10 analysts who follow the stock, five rate it a "Buy" and five a "Hold." And the stock is inexpensive right now, trading at slightly more than nine times forward earnings. Consider that major drugmakers like Eli Lilly (NYSE: LLY), Merck (NYSE: MRK), and Johnson & Johnson (NYSE: JNJ) are all trading at more than 20 times forward earnings. So, for investors looking for stocks trading cheaply relative to peers that deliver a strong dividend yield and have potential for future price appreciation, Sanofi right now checks all the boxes. Before you buy stock in Sanofi, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Sanofi wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $443,461!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,307,633!* Now, it’s worth noting Stock Advisor’s total average return is 973% — a market-crushing outperformance compared to 213% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 26, 2026. Matthew Benjamin has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Eli Lilly and Merck. The Motley Fool recommends Johnson & Johnson. The Motley Fool has a disclosure policy. Sanofi Boasts a Dividend Yield of 5.4%, Trades Below 9x Earnings, and Just Got an FDA Win. Are Income Investors Missing a Rare Opportunity? was originally published by The Motley Fool

Randomized Phase 2 trial in microsatellite stable colorectal cancer (MSS CRC) ongoing, with results expected in 1H 2027; potential registration trial expected in 2027 once recommended dose regimen has been established Data reported at AACR from triple combination therapy in 1L hepatocellular carcinoma (HCC) and late-line MSS CRC highlights muzastotug’s potential as a backbone combination treatment for multiple tumor types across all lines of therapy Initiated dosing in a global Phase 1/2 basket trial evaluating muzastotug in combination with a next-generation investigational IO agent through a clinical collaboration with Sanofi Investigator-initiated Phase 2 trial of muzastotug in neoadjuvant setting for colorectal cancer is ongoing Cash and cash equivalents of $127.9 million include proceeds of public offering in April 2026; provide runway into late 2028 SAN DIEGO and SUZHOU, China, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the six months ended June 30, 2026, and provided corporate updates. “The first half of 2026 was a period of meaningful advances for the company, as our lead program, muzastotug, a masked, anti-CTLA-4 SAFEbody, continues to demonstrate compelling efficacy and a favorable safety profile in MSS CRC and HCC,” said Peter Luo, Ph.D., CEO and President of R&D at Adagene. “The strength of muzastotug as a potential backbone therapy continues to be recognized with recent collaborations and the clinical data to date demonstrates the enhanced safety of muzastotug relative to legacy CTLA-4 therapies, even at approximately ten times higher doses. This enhanced safety allows muzastotug to be used as a potential backbone therapy in combination with pembrolizumab and/or other standard of care therapies, such as fruquintinib. We remain encouraged by the durable benefit we are seeing.” “We also welcomed Peter Lebowitz to our Scientific and Strategic Advisory Board, further strengthening the clinical expertise guiding our programs;” continued Dr. Luo. “The equity offering in April brought in new investors and extended our cash runway into late 2028, allowing us to accelerate our pipeline and deliver on our mission to transform cancer immunotherapy for patients.” PIPELINE HIGHLIGHTS Muzastotug (ADG126) Phase 1b/2 study in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases. Updated data announced in April 2026 highlighted clinical results from patients that have been treated with a muzastotug dose of either 10 mg/kg or 20 mg/kg, in combination with pembrolizumab. Across 67 patients in all cohorts, a low 4% overall discontinuation rate, no dose limiting toxicities, and no Grade 4 or 5 treatment-related adverse events (TRAEs); Grade 3 TRAEs were 15% in the 10 mg/kg cohorts and 38% in the 20 mg/kg cohorts, which were generally transient and manageable. Enrollment into the randomized Phase 2 trial is well on-track, and results are expected in 1H 2027. The Phase 2 trial is enrolling patients into two arms designed to allow dose regimen selection for the Phase 3 trial. Both arms include an induction phase to drive early efficacy and a maintenance phase to prolong overall survival. A potential registration trial is expected to begin once the recommended dose regimen has been established, supported by the Fast Track Designation and FDA alignment under Project Optimus. Triple combination Phase 1b/2 study of muzastotug, atezolizumab and bevacizumab, in patients with first-line HCC: Data presented at the American Association for Cancer Research (AACR) annual meeting in April 2026 included results from the study which is evaluating the triple combination of muzastotug, atezolizumab and bevacizumab compared to atezolizumab and bevacizumab as an active control arm. Interim results from six patients in the muzastotug arm (18.8 months median duration of follow-up) demonstrated a 66.7% ORR (4/6) using HCC-specified modified RECIST v1.1 criteria. ORR was 50.0% (3/6) using RECIST v1.1 criteria. The median PFS was 8.2 months (same for both RECIST criteria) and the median OS was not yet reached at the data cut but was greater than 22 months. These results compared favorably to the 40 patients in the active control arm (17.2 months median duration of follow-up) that demonstrated an ORR of 32.5% (13/40) using HCC-specified modified RECIST v1.1 criteria, median PFS of 5.5 months, and median OS of 17.5 months. Using RECIST v1.1 criteria, the ORR was 17.5% (7/40) and the median PFS was 4.3 months. The triplet regimen of muzastotug, atezolizumab and bevacizumab was well-tolerated with safety data comparable to the doublet active control arm of atezolizumab and bevacizumab. Grade 3 or greater TRAEs were 50% (3/6) in the muzastotug arm and 45% (18/40) in the active control arm, which supports the potential for continuous dosing with muzastotug. Ongoing muzastotug plus atezolizumab treatment after bevacizumab discontinuation suggests potential flexibility to modify individual agents during safety-related interruptions while preserving durable clinical benefit from the muzastotug and atezolizumab doublet for an extended period of time. Triple combination Phase 1b/2 study of muzastotug, pembrolizumab and fruquintinib in patients with advanced or metastatic MSS CRC: In data presented at AACR, interim results from the study demonstrated a 25% confirmed ORR (1/4) among patients at a dose of 10 mg/kg every 6 weeks (Q6W) of muzastotug (6.7 months median follow-up), and a 40% ORR (2/5) among patients at a dose of 15 mg/kg Q6W of muzastotug (5.9 months median follow-up). The triplet regimen was well-tolerated with no new safety signals, relative to known CTLA-4, PD-1, and fruquintinib monotherapy and combination safety data. There were no dose-limiting toxicities, 25 – 60% Grade 3 TRAEs, and no Grade 4 or Grade 5 TRAEs. Investigator-initiated Phase 2 trial of muzastotug in the neoadjuvant setting, in combination with pembrolizumab, for the treatment of MSS CRC: Patients in this study received muzastotug up to 20 mg/kg in combination with pembrolizumab prior to surgery. Using paired tumor biopsies collected before and after treatment, the study evaluates muzastotug’s pharmacokinetic profile in tumor tissue and its pharmacodynamic effects on the immune landscape of the tumor microenvironment. These analyses are designed to further elucidate muzastotug’s unique mechanism of action and its potential to deliver an enhanced therapeutic index. Additionally, the trial’s primary endpoint is the rate of Major Pathologic Response (MPR), defined as ≤10% residual viable tumor in the surgical specimen, and is being evaluated in up to 20 patients. Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability. Preliminary clinical data will inform future development of muzastotug in the neoadjuvant setting. COLLABORATION UPDATES Sanofi: A global Phase 1/2 basket trial evaluating muzastotug in combination with a next-generation investigational IO agent in patients with advanced solid tumors is being sponsored and conducted by Sanofi as part of an external clinical collaboration. Incyte: Established clinical collaboration to evaluate muzastotug in combination with Incyte’s TGFβR2xPD-1 bispecific antibody (INCA33890), a leading PD-1-based bispecific program which has demonstrated promising clinical efficacy and safety data as a monotherapy in immune checkpoint sensitive and insensitive cancers, including MSS CRC with and without liver metastases. A Phase 1 combination study in 3L MSS CRC patients with and without liver metastases, sponsored and conducted by Incyte, is expected to begin later this year. Exelixis: Preclinical data was presented at AACR from antibody-drug conjugate, XB404, built with Adagene’s SAFEbody masking technology and designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects. XB404 demonstrated dose-related tumor growth inhibition and improved survival in cell line models. Investigational New Drug (IND)-enabling studies are ongoing. ConjugateBio: The collaboration is ongoing with bispecific ADCs utilizing an Adagene-derived antibody, further demonstrating scalable platform potential. CORPORATE UPDATES Added Peter Lebowitz, M.D., Ph.D., former Global Head of Oncology R&D for Johnson & Johnson, to the Scientific and Strategic Advisory Board (SAB), who is helping guide the clinical development of muzastotug, including strategies to advance the program into registration studies. Completed underwritten public offering of American depositary shares in April 2026 with approximately $70 million in gross proceeds. FINANCIAL HIGHLIGHTS Cash and Cash Equivalents:Cash and cash equivalents were US$127.9 million as of June 30, 2026, compared to US$74.5 million as of December 31, 2025. Cash and cash equivalents included proceeds received from the ATM offering and underwritten public offering completed in April 2026. The company expects a cash runway extending into late 2028. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$5.7 million as of June 30, 2026 from US$6.1 million as of December 31, 2025. The associated loan proceeds were primarily used to pay for the company’s R&D activities in China. Net Revenue:Net revenue was US$1.6 million for the six months ended June 30, 2026, compared to nil for the same period in 2025. The increase reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology licensing agreements with Sanofi and Exelixis, respectively. Research and Development (R&D) Expenses:R&D expenses were US$14.0 million for the six months ended June 30, 2026, compared to US$12.0 million for the same period in 2025. The increase of approximately 16.2% in R&D expenses reflects continued clinical focus and development of muzastotug, the company’s masked, anti-CTLA-4 SAFEbody ADG126. Administrative Expenses:Administrative expenses were US$4.2 million for the six months ended June 30, 2026, compared to US$3.7 million for the same period in 2025. The increase was mainly due to increase in both personnel and office-related expenses. Net Loss:Net loss attributable to Adagene Inc.’s shareholders was US$16.4 million for the six months ended June 30, 2026, compared to US$13.5 million for the same period in 2025. Ordinary Shares Outstanding:As of June 30, 2026, there were 83,929,180 ordinary shares issued and outstanding. Each American depositary share, or ADS, represents one and one quarter (1.25) ordinary shares of the company. Non-GAAP Net Loss: Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding share-based compensation expenses, was US$14.2 million for the six months ended June 30, 2026, compared to US$11.4 million for the same period in 2025. Please refer to the section in this press release titled “Reconciliation of GAAP and Non-GAAP Results” for details. Non-GAAP Financial Measures: The company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the period, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the period help identify underlying trends in the company’s business that could otherwise be distorted by the effect of certain expenses that the company includes in its loss for the period. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the period provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its financial and operational decision-making. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the period should not be considered in isolation or construed as an alternative to operating profit, loss for the period or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss and non-GAAP net loss per ordinary shares for the period and the reconciliation to their most directly comparable GAAP measures. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the period here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the company’s data. The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the period represent net loss attributable to ordinary shareholders for the period excluding share-based compensation expenses. Share-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. The company believes that the exclusion of share-based compensation expenses from the net loss in the Reconciliation of GAAP and Non-GAAP Results assists management and investors in making meaningful period-to-period comparisons in the company's operating performance or peer group comparisons because (i) the amount of share-based compensation expenses in any specific period may not directly correlate to the company’s underlying performance, (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, and (iii) other companies may use different forms of employee compensation or different valuation methodologies for their share-based compensation. Please see the “Reconciliation of GAAP and Non-GAAP Results” included in this press release for a full reconciliation of non-GAAP net loss and non-GAAP net loss per ordinary shares for the period to net loss attributable to ordinary shareholders for the period. About AdageneAdagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody precision masking technology in multiple approaches at the vanguard of science. Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies, while minimizing on-target off-tumor toxicity in healthy tissues. Adagene’s lead clinical program, muzastotug (ADG126), is a masked, anti-CTLA-4 SAFEbody with FDA Fast Track designation that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. Muzastotug is currently in Phase 1b/2 and Phase 2 clinical studies in combination with anti-PD-1 therapy, particularly focused on microsatellite stable (MSS) metastatic colorectal cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multi-specific T-cell engagers. For more information, please visit: https://investor.adagene.com.Follow Adagene on WeChat, LinkedIn and X. SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Safe Harbor Statement This press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Investor Contacts:Raymond [email protected] Corey DavisLifeSci [email protected] Unaudited Consolidated Balance Sheets Unaudited Consolidated Statements of Comprehensive Loss Reconciliation of GAAP and Non-GAAP Results

Interested in Novavax, Inc.? Here are five stocks we like better. Q2 revenue fell to $57 million from $239 million a year earlier, largely because the prior-year quarter included a $202 million milestone benefit. Novavax ended the quarter with $743 million in cash and receivables and cut combined non-GAAP R&D and SG&A costs by 36% year over year. Novavax highlighted potential near-term Sanofi payments totaling $200 million, including a $125 million milestone tied to starting a Phase III COVID-19/influenza vaccine trial and a $75 million manufacturing technology-transfer payment expected around mid-2027. The company raised its 2026 adjusted revenue outlook to $235 million-$275 million and lowered its GAAP R&D and SG&A expense midpoint to $390 million. It also reported expanding Matrix-M partnerships into oncology, advanced its C. difficile vaccine toward potential clinical entry in 2027, and maintained targets for non-GAAP profitability as early as 2028. Analysts Think These Stocks Could More Than Double in Value Novavax (NASDAQ:NVAX) reported second-quarter 2026 revenue of $57 million and a net loss of $53 million, while highlighting progress in its Sanofi partnership, expanding use of its Matrix-M adjuvant platform and continued cost reductions. Revenue declined from $239 million a year earlier, primarily because the second quarter of 2025 included a $202 million benefit from a biologics license application approval milestone and a Takeda amendment, Chief Financial Officer Jim Kelly said. The latest quarter included $19 million in product sales, up 76% year over year, driven by demand for Matrix-M from Takeda and Serum Institute. Novavax also recorded $36 million in Sanofi-related revenue, largely from research-and-development reimbursements and amortization. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Is Biotech’s Bull Run Over? Examining Election Impacts The company ended the quarter with $743 million in cash and accounts receivable. Kelly said Novavax reduced combined non-GAAP R&D and selling, general and administrative expenses by 36% year over year during the quarter. Chief Executive Officer John Jacobs said Sanofi has confirmed its intention to be among the first companies to enter the COVID-19/influenza combination-vaccine market. Sanofi is in advanced discussions with regulators on the timing of a Phase III study for a program combining Nuvaxovid with Sanofi’s influenza vaccines, according to Novavax. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Moderna Dips on Q2 Earnings But Can It Rip on a Short Squeeze? Initiation of that Phase III study in either the U.S. or European Union would trigger a $125 million milestone payment to Novavax. Separately, Novavax expects to earn a $75 million manufacturing technology-transfer milestone from Sanofi around mid-2027. Kelly said the anticipated payment would extend the company’s cash runway from 2028 into 2029. Jacobs said the two potential milestones provide visibility to an additional $200 million in near-term payments, on top of more than $1 billion in upfront payments, milestones, royalties and cost savings that Novavax has already realized through its Sanofi relationship. → Ulta's Growth Is Real, But So Are the Risks Sanofi is preparing a broader commercial campaign for Nuvaxovid in the U.S., including pharmacy activation and direct-to-consumer outreach, Chief Strategy Officer Elaine O’Hara said. The partner also plans to expand availability to markets including the United Kingdom, Germany and Canada during the coming season. Kelly described the U.S. COVID-19 vaccine market as primarily consumer- and retail-driven, saying more than 85% of vaccinations are administered through retail channels. He said Novavax expects Sanofi’s direct-to-consumer campaign and retail presence to support a multi-year effort to establish the protein-based vaccine option in the market. Novavax said the vaccine Sanofi plans to distribute matches the strain selections of U.S. and other regulators, and Jacobs said the company remains on track to deliver doses to Sanofi. Management emphasized expanding interest in Matrix-M, the company’s saponin-based adjuvant. Jacobs said four of the world’s 10 largest pharmaceutical companies now have licensing or material transfer agreements involving Matrix-M. Licensed partners and material transfer agreement holders collectively have rights to more than 30 areas of experimentation in infectious disease and oncology, according to the company. O’Hara said Novavax executed a material transfer agreement during the second quarter with a leading global pharmaceutical company active in immuno-oncology for therapeutic cancer-vaccine applications. She said cancer-vaccine programs may generate meaningful clinical data and development milestones more quickly than infectious-disease vaccines because trials typically enroll patients with active disease. Head of R&D Bob Walker said Novavax is increasingly focused on Matrix-M’s possible oncology applications. A study published by Novavax in npj Vaccines showed that Matrix-M supports antigen cross-presentation and downstream CD8 T-cell activation, he said. Walker also cited Stanford research published in Science Advances on saponin adjuvants used alone or with innate immune stimulators. Novavax is conducting internal oncology research across multiple target types and expects partner work to add independent data sets. Jacobs said the company believes Matrix-M “as it stands today” may have potential in oncology, while Novavax is also evaluating other approaches that could expand its use across both oncology and infectious disease. Novavax said it initiated good manufacturing practice production and pre-investigational new drug interactions with the FDA for its multivalent C. difficile vaccine candidate. Walker said the company remains on track for potential clinical entry as early as 2027. The candidate is intended to cover most circulating C. difficile clades and ribotypes, according to Walker. In response to analyst questions, he said Novavax is generally pursuing preventive vaccines and that Phase I plans are not being disclosed in detail, beyond describing the study as a standard dose-escalation effort focused on safety. Walker also said preclinical models have shown evidence that the candidate could induce mucosal immunity, although the company will discuss the finding further if it is observed in human studies. Novavax raised its 2026 adjusted total revenue framework to $235 million to $275 million, from a prior midpoint that was $5 million lower. The midpoint of $255 million reflects a $5 million increase in adjusted supply sales, a $10 million increase in other partner-related revenue, and a $10 million reduction in partner R&D reimbursements as Novavax completes obligations more efficiently. The company expects most remaining 2026 revenue to arrive in the fourth quarter, driven by the COVID-19 vaccine season. Its adjusted revenue framework excludes Sanofi supply sales, royalties and milestones. Novavax also reduced its midpoint guidance for combined 2026 GAAP R&D and SG&A expenses by $10 million to $390 million. It reiterated expected non-GAAP R&D and SG&A expenses, net of partner reimbursements, of $325 million at the midpoint. Looking to 2028, the company continues to target combined non-GAAP R&D and SG&A expenses of $150 million to $200 million, non-GAAP profitability as early as 2028, and repayment of pandemic-era advance purchase agreement liabilities by the first quarter of 2029. Kelly said Novavax anticipates reducing headcount to less than half of its first-quarter 2026 level and is exploring a reduction of more than 50% in its operating footprint. 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]. The article "Novavax Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

BioMarin Pharmaceutical BMRN reported second-quarter 2026 adjusted earnings of $1.20 per share, which beat the Zacks Consensus Estimate of 96 cents. However, the bottom line declined 16.7% year over year from $1.44. Total revenues were $989.7 million, up 20% year over year, beating the Zacks Consensus Estimate of $922 million. Growth was driven by new Amicus-acquired products, Voxzogo patient additions and stronger Palynziq demand. Shares of BioMarin were up 4.4% in after-market trading on Thursday following the earnings announcement. The positive stock reaction came as both earnings and revenues topped expectations and management raised key elements of its 2026 financial guidance. Year to date, BMRN stock has gained 3.4% compared with the industry’s 3.6% growth. Image Source: Zacks Investment Research Net product revenues totaled nearly $984.4 million, up about 21% year over year, driven by higher revenues from the company’s Metabolic Conditions drugs, as well as Voxzogo. Voxzogo generated $253 million in sales, up 14% year over year from $221 million. Sales also beat the Zacks Consensus Estimate of $238.2 million. The number of children treated globally increased more than 20% year over year. BioMarin said about 90% of U.S. children treated with Voxzogo remained on therapy through the end of July after a competing product entered the market. More than half of new U.S. patient starts during the quarter were children under two years of age. Metabolic Conditions revenues totaled $695 million, up 25% year over year. The portfolio now comprises seven therapies, including Galafold and Pombiliti-Opfolda, which were added following the Amicus acquisition. Palynziq sales jumped 27% to $135 million, topping the Zacks Consensus Estimate of $112.7 million. Naglazyme revenues rose 5% to $135 million, which also came above the consensus estimate of $125.9 million. Brineura sales increased 4% to $51 million. Vimizim revenues fell 10% to $194 million, reflecting the timing of large government orders outside the United States. Sales missed the Zacks Consensus Estimate of $205.8 million. Aldurazyme sales declined 21% to $44 million due to timing of order fulfillment to Sanofi SNY. Galafold contributed $106 million following the Amicus acquisition. BioMarin said the therapy maintained broad-based patient growth, supported by increased diagnosis and patient identification. The Sanofi-related Aldurazyme order timing was a separate headwind within the portfolio. BioMarin signed a collaboration agreement with Sanofi’s subsidiary, Genzyme, for Aldurazyme. SNY, through Genzyme, is BMRN’s sole customer for Aldurazyme. The Sanofi subsidiary is responsible for marketing and selling Aldurazyme to third parties. Kuvan generated $24 million in second-quarter sales, down 11% from $27 million a year earlier. Roctavian revenues were $12 million, up 33% year over year from $9 million. Royalty and other revenues were $5.3 million compared with $12.4 million in the year-ago quarter. BioMarin raised its 2026 total revenue guidance to $3.875-$3.925 billion from $3.825-$3.925 billion. Metabolic Conditions revenue guidance was maintained at $2.725-$2.775 billion. Voxzogo revenue guidance was increased to $1-$1.05 billion from $975-$1.025 billion. Other revenues are expected to be in the range of $100-$125 million in 2026, unchanged from the previous guidance. Adjusted earnings guidance was raised to $4.90-$5.10 per share from $4.85-$5.05. BioMarin submitted a supplemental new drug application (NDA) to the FDA seeking approval of Voxzogo for hypochondroplasia after the phase III CANOPY-HCH-3 study met its primary endpoint. The company expects to provide an update on the application status with its third-quarter earnings update. The FDA also accepted BioMarin's supplemental NDA for full approval of Voxzogo in children with achondroplasia, with a Feb. 28, 2027, target action date. Meanwhile, the company discontinued BMN 401 after the ENERGY 3 study failed to meet one of its two co-primary endpoints for the treatment of ENPP1 deficiency. A data update from the phase II/III study of BMN 333 for achondroplasia is expected in 2027. In the second quarter, the European Commission approved Palynziq for adolescents aged 12 years and older with phenylketonuria (PKU). The label expansion broadens access to Palynziq, which enables patients with PKU to achieve physiologic phenylalanine levels while reducing dietary restrictions, regardless of disease severity. BioMarin Pharmaceutical Inc. price-consensus-eps-surprise-chart | BioMarin Pharmaceutical Inc. Quote BioMarin's quarter showed broad commercial momentum, with Voxzogo growth and the newly acquired Galafold contribution supporting a strong revenue beat. Palynziq and Naglazyme also exceeded expectations, while Vimizim and Aldurazyme faced order-timing pressure. The raised outlook adds to the positive read-through from the quarter, though product-level volatility remains evident. In particular, Aldurazyme's decline reflected order fulfillment timing to Sanofi, making SNY-related ordering an important factor to watch alongside competitive dynamics in Voxzogo. BioMarin currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33, while estimates for 2027 have increased from $3.64 to $3.92 during the same time. HRMY shares have gained 3.5% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Novavax Inc (NASDAQ:NVAX) has secured licensing or material transfer agreements with 4 of the TOP10 global pharmaceutical companies, including Pfizer, for its Matrix-M adjuvant, covering over 30 areas of exploration in infectious disease and oncology. The Sanofi partnership is progressing well, with Sanofi confirming its intent to be a first mover in the combination COVID-19/influenza vaccine market and entering advanced regulatory discussions for a Phase 3 study, which would trigger a $125 million milestone payment. The company is seeing strong momentum in oncology, executing an MTA with a leading global pharma company in immuno-oncology and generating encouraging preclinical data supporting Matrix-M's potential in therapeutic cancer vaccines. Novavax Inc (NASDAQ:NVAX) is on track to achieve an approximately 90% reduction in operating expenses from peak, with a 36% decrease in combined R&D and SG&A expenses in Q2 2026, and is reiterating its goal of reaching non-GAAP profitability as early as 2028. The company increased its full-year 2026 revenue guidance to between $235 million and $275 million, driven by strong demand for Matrix-M from commercial partners like Takeda and Serum Institute, and expects to extend its cash runway into 2029 with the anticipated $75 million manufacturing tech transfer milestone from Sanofi. Novavax Inc (NASDAQ:NVAX) reported a net loss of $53 million in Q2 2026, with total revenue of $57 million, a significant decline from $239 million in the prior year, largely due to the absence of one-time milestone payments. The company's future profitability is heavily dependent on the timing of Sanofi's combination vaccine launch, which remains uncertain and outside of Novavax's direct control. Novavax Inc (NASDAQ:NVAX) faces potential non-cash fixed asset write-offs of up to $35 million in 2027 as part of its plan to reduce its operating footprint by over 50%. The company is reducing its partner R&D reimbursements guidance by $10 million for 2026, reflecting lower expected reimbursements as it delivers efficiently on partner-related obligations. Novavax Inc (NASDAQ:NVAX) remains reliant on a few key partners, particularly Sanofi, for significant milestone payments and commercial success, and the company cannot provide guidance on partner activities, creating uncertainty for investors. Warning! GuruFocus has detected 7 Warning Signs with NVAX. Is NVAX fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more color on Sanofi's advanced discussions with regulators regarding the Phase 3 study for the combined COVID-19/influenza vaccine, and what needs to be aligned for that trial to start?A: John Jacobs (President and CEO) confirmed that Sanofi has explicitly stated their intent to be among the first movers in the combination vaccine market and are in advanced discussions with regulators regarding Phase 3 study timing. He emphasized that these statements are directly from Sanofi and have been signed off by them, reflecting their strong commitment despite recent leadership changes. The initiation of a Phase 3 study in either the US or EU would trigger a $125 million milestone payment to Novavax. Q: What is the updated 2026 financial outlook, and how does the expected $75 million manufacturing tech transfer milestone from Sanofi impact the cash runway?A: Jim Kelly (Chief Financial Officer) announced an increased full-year 2026 revenue framework of $235 million to $275 million in adjusted total revenues, a $5 million increase at midpoint. He also confirmed the expectation to earn a $75 million manufacturing tech transfer milestone from Sanofi by mid-2027, which would extend the current cash runway from 2028 into 2029. The company reiterated its 2028 non-GAAP R&D and SG&A expense guidance of $150 million to $200 million and the goal of reaching non-GAAP profitability as early as 2028. Q: How much of the 2026 COVID-19 vaccine uptake assumptions depend on contract wins versus physician/patient-driven uptake, including Sanofi's DTC outreach?A: Jim Kelly (CFO) explained that the US market is consumer and retail-driven, with over 85% of shots coming through the retail market. Sanofi has contracted with all major US retailers and is rolling out a direct-to-consumer advertising campaign emphasizing the favorable tolerability profile of Nuvaxovid. John Jacobs added that Sanofi is also launching in additional international markets this year, including the UK, Germany, and Canada, positioning for a robust season and a multi-year long-term market-building strategy. Q: Can you provide details on the Phase 1 trial design for the C. difficile vaccine candidate, and are potential Phase 2/3 costs embedded in the 2028 operating expense framework?A: Bob Walker (Head of R&D) stated that the Phase 1 trial design is a standard dose escalation study focused on characterizing safety and demonstrating an adequate safety profile for further development. Jim Kelly (CFO) confirmed that the company has contemplated the ability to fund advanced development programs like C. diff, potentially as early as 2028, within the provided forward-looking expense guidance range. The company is on track for potential clinical entry as early as 2027, having initiated GMP manufacturing and pre-IND interactions with the FDA. Q: Given the recent leadership changes at Sanofi and their portfolio review, what tangible steps give you confidence that the combo vaccine remains a strategic priority for them?A: John Jacobs (CEO) emphasized that despite internal changes at Sanofi, they are seeing more engagement behind the scenes, not less. He stressed that the statements about Sanofi's intent to be a first mover in the combination vaccine market and their advanced regulatory discussions are directly provided by Sanofi and signed off by them. The company is "leaning in" with stronger commitment, and Novavax is more encouraged than ever about the partnership's potential. Q: What is the biggest need in the COVID-flu combination vaccine market, and what level of engagement will Novavax have with Sanofi as they take their combination program into Phase 3?A: Jim Kelly (CFO) highlighted the continued burden of disease, especially in the over-65 population, citing recent data on deaths and hospitalizations. Elaine O'Hara (Chief Strategy Officer) clarified that Novavax does not provide guidance or advice to Sanofi on their combo program, as they are technically competitors in that arena with their own combination influenza/COVID program. The company views the advancement to Phase 3 as a critical value-unlocking catalyst. Q: Can you provide an update on the Pfizer partnership and the progress of the 30+ areas of exploration under MTA agreements?A: Elaine O'Hara (Chief Strategy Officer) stated that Novavax continues to collaborate with Pfizer and uphold commitments under the license agreement, expressing excitement about the progress being made, though contractually restricted from discussing specific fields. Regarding the 30+ areas of exploration, she noted that each MTA is different, with partners evaluating different indications and moving on different timelines, making it difficult to predict when they might progress into full licensing agreements. The company is encouraged by the quality and diversity of organizations evaluating Matrix-M. Q: Is the C. diff vaccine candidate being developed as a prophylactic or therapeutic vaccine, and who would be the target population?A: Bob Walker (Head of R&D) indicated that while it is early days, the general philosophy is to develop a preventive vaccine, but the company is considering all options as they build the database. He noted that the candidate has the potential to cover the vast majority of circulating C. diff clades and ribotypes, and the company is exploring the possibility of inducing mucosal immunity, though preclinical models are limited and they will discuss this further if observed in human studies. Q: Do your oncology partners want Matrix-M as it currently exists, or are they licensing the components to experiment with different formulations?A: Bob Walker (Head of R&D) confirmed that Novavax believes the final version of Matrix-M as it stands today has potential in oncology and is exploring its potential deeply. The company is also looking at other approaches to expand its utility, including combining it with innate immune stimulators like TLR agonists. He noted that early data generated internally and shared under NDA with a recent partnera top-10 pharma and global leader in oncologyencouraged them to evaluate Matrix-M across a variety of oncology targets. Q: Has the strain selection for the fall COVID-19 vaccine season been completed, and is Novavax prepared to scale manufacturing for this season's strain?A: Bob Walker (Head of R&D) confirmed that the vaccine Sanofi will distribute in the US matches the strain selection of US and other regulators, and Novavax is on track for delivering doses to Sanofi. Jim Kelly (CFO) added that this is the final year of Novavax offering commercial support directly to Sanofi, and Sanofi is well-prepared to For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Kymera Therapeutics, Inc. KYMR reported a second-quarter 2026 loss of 62 cents per share, narrower than the Zacks Consensus Estimate of a loss of 64 cents. The company posted a loss of 95 cents in the year-ago period. Revenues surged to $65 million from $11.5 million in the year-ago quarter and surpassed the Zacks Consensus Estimate of $39 million. Year to date, shares of KYMR have surged 35.6% compared to the industry’s 2.6% gain. Image Source: Zacks Investment Research All second-quarter revenues came from collaboration agreements. Kymera recognized a $45 million option exercise fee related to Gilead Sciences, Inc.’s GILD exclusive license for KT-200, its oral CDK2 molecular glue degrader candidate. The company also recorded a $20 million milestone payment after Sanofi SNY initiated a phase I study of KT-485, an oral, potent and selective second generation IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa patients. Management said all deferred revenues have now been recognized. Consequently, Kymera does not expect additional revenues in 2026. Future collaboration revenues will depend on milestones achieved under the Gilead or Sanofi agreements in 2027 and beyond. Research and development expenses increased 52.4% year over year to $119.48 million. The increase reflected higher investments in the STAT6 program, platform and discovery programs, along with continued expansion of the R&D organization. R&D expenses included $10.4 million of stock-based compensation. Excluding that noncash expense, adjusted cash R&D spending was $109.1 million. General and administrative expenses rose 19.7% to $21.13 million. The increase was driven by higher legal and professional service costs, personnel expenses and facility-related spending. Cash, cash equivalents and marketable securities totaled $1.50 billion as of June 30, 2026, compared with $1.62 billion at the end of 2025. Management maintained its expectation that available capital will fund operations into 2029. The runway is expected to support completion of KT-621’s phase IIb studies in atopic dermatitis and asthma, as well as KT-579’s planned lupus proof-of-concept program. Kymera also expects to fund the initial stages of a phase III asthma study and most of the planned phase III atopic dermatitis study for KT-621. KT-621, an investigational once-daily oral STAT6 degrader, is being developed for type II inflammatory diseases. Kymera completed enrollment in the BROADEN2 phase IIb study of KT-621 in moderate-to-severe atopic dermatitis (AD) nearly six months ahead of schedule. Top-line data are now expected by year-end 2026, six months earlier than the company’s previous target. Subject to regulatory discussions, phase III studies in atopic dermatitis are planned to begin by mid-2027. The trial is evaluating three doses of the once-daily oral STAT6 degrader against placebo. Its primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index score at week 16. Enrollment is also underway in the BREADTH phase IIb study in patients with moderate-to-severe eosinophilic asthma. Kymera continues to expect top-line data in late 2027 and has initiated an open-label extension that permits eligible participants to receive KT-621 for up to 52 additional weeks. Beyond STAT6, Kymera is progressing KT-579, a first-in-class oral degrader of IRF5, a transcription factor positioned as a master regulator across autoimmune diseases. Enrollment is ongoing in the phase I study of KT-579 in healthy volunteers, with data expected in the fourth quarter of 2026. The study is assessing whether the oral IRF5 degrader can achieve more than 90% degradation in blood while maintaining a favorable safety profile. Kymera plans to initiate a proof-of-concept study in lupus patients soon after completing the healthy-volunteer trial. Sanofi initiated the first-in-human phase I study evaluating KT-485 (SAR447971) in adult healthy volunteers and hidradenitis suppurativa patients. KT-485 has the potential to offer a novel oral approach for a variety of chronic immuno-inflammatory diseases.  Under the agreement, Sanofi is responsible for the program's development, regulatory and commercialization activities. In April 2026, Gilead Sciences exercised its option to exclusively license KT-200, Kymera's first-in-class oral CDK2 molecular glue degrader, triggering a $45 million milestone payment. KT-200 is being developed for breast cancer and other solid tumors and has the potential to improve the current standard of care. Gilead plans to advance the candidate into IND-enabling studies, with an IND filing targeted for 2027. Kymera put up an impressive performance in the second quarter. The pipeline progress is encouraging. R&D expenses continue to increase as the company advances its pipeline. Kymera Therapeutics, Inc. price-consensus-eps-surprise-chart | Kymera Therapeutics, Inc. Quote The investment thesis centers on pipeline execution in targeted protein degradation, led by KT-621 in phase II for AD and asthma. Additional positive pipeline updates on KT-621 will be a boost for the stock. The pipeline offers additional opportunities beyond KT-621. Phase I data for the IRF5 degrader KT-579 is expected in the fourth quarter of 2026, followed by a planned proof-of-concept study in lupus. Partnered programs with GILD and SNY also reduce some development burden while generating milestone-based revenues. Kymera’s strong cash balance supports pipeline development and limits near-term financing pressure, although spending will increase as the company expands its clinical and commercial infrastructure. Kymera Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kymera Therapeutics, Inc. (KYMR) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

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 GAITHERSBURG, Md., Aug. 6, 2026 /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. 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 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: 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. Revenue Framework Footnotes 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 CallNovavax 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 NovavaxNovavax, 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 MeasuresThe 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 StatementsThis 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. Contacts: InvestorsNaina Zaman240-410-5353 [email protected] Media Yvonne [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/novavax-reports-second-quarter-2026-financial-results-and-operational-highlights-302844473.html

This article first appeared on GuruFocus. Net Sales: EUR356.5 million in H1 2026, down 13.5% year-over-year (down 11.8% on a comparable basis). Core EBITDA: EUR20.7 million, representing a 5.8% margin, down from a 9.6% margin in H1 2025. EBITDA: Negative EUR43.1 million, reflecting non-recurring costs related to the Focus 27 transformation. Operating Income: Negative EUR135.7 million, including EUR92.6 million in depreciation and amortization, of which EUR33 million related to impairments. Net Loss: EUR141.5 million in H1 2026, compared to a net loss of EUR28.5 million in H1 2025. Capital Expenditures (CapEx): EUR39.1 million, representing 11% of net sales, with 64% dedicated to growth and performance initiatives. Net Debt: EUR37.9 million at the end of H1 2026, compared with a net cash position of EUR68.2 million at the end of 2025. API Solutions to Sanofi: Decreased by 36.2% (down 28.4% excluding the Averil divestment), impacted by product discontinuations. API Solutions to Other Clients: Decreased by 11%, due to weaker demand for corticosteroids and complex molecules in Frankfurt. Total CDMO Sales: Increased by 2%, with a 13.8% increase for Sanofi and an 8.2% decrease for other customers. Non-Recurring Items: Totaled EUR63.8 million, including EUR42.5 million in employee-related expenses (one-off linked to Frankfurt redundancy plan) and EUR11.1 million in idle costs. Full-Year 2026 Outlook: Net sales expected down around 10% on a comparative basis; core EBITDA margin expected around 6% at constant perimeter, impacted by approximately EUR9 million adverse foreign exchange effect. Warning! GuruFocus has detected 6 Warning Signs with EAPIF. Is EAPIF fairly valued? Test your thesis with our free DCF calculator. Release Date: July 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Focus 27 transformation is progressing on schedule, with the signing of the Brindisi divestment agreement marking a key milestone. CDMO sales increased by 2% overall, with a 13.8% rise for Sanofi, and commercial phase projects now represent 94% of total CDMO sales. Cost efficiency improved through disciplined execution of Focus 27, with further reductions in sales and general expenses. The company maintains a strong liquidity position with a 451 million RCF, of which only a small portion has been drawn, and no covenants until H1 2027. New commercial leadership and organizational changes are building momentum in CDMO, with increased RFPs from top-tier pharma companies and interest in fermentation capabilities. Net sales declined 13.5% year-over-year, with a 11.8% drop on a comparable basis, impacted by product discontinuations and softer demand. Core EBITDA margin fell to 5.8% from 9.6% in H1 2025, due to lower fixed cost absorption and adverse foreign exchange effects. Net loss widened significantly to 141.5 million in H1 2026, from 28.5 million in H1 2025, driven by impairments and restructuring costs. The appreciation of the Hungarian forint is expected to weigh approximately 9 million on full-year core EBITDA, leading to a revised margin outlook of around 6%. The company's net debt position turned to 37.9 million from a net cash position of 68.2 million at end-2025, reflecting working capital and investment outflows. Q: How much of the API solutions weakness do you consider temporary versus structural? Do you expect customer demand to improve in 2027 or should we continue to assume a challenging market environment? A: David Sanyal (CEO) explained that the answer is not black and white. There is a structural change in demand for highly commoditized simple small molecules, similar to those previously discontinued in Frankfurt, which they expect to continue declining over the next couple of years. However, they also see temporary demand weakness driven by a significant destocking effect at customers post-COVID, which should impact 2026 and possibly part of 2027. For some products, demand remains strong, justifying continued investment in capacity and performance improvements. Q: CDMO performed better than expected in H1. Should we expect this momentum to continue into H2 and 2027? A: David Sanyal (CEO) confirmed that they are seeing interesting momentum building in CDMO, supported by new hires with strong industry backgrounds. They are progressing on long-term programs with top-tier pharma companies and seeing significant RFPs from other large pharma firms. He also highlighted a new demand driver: their fermentation capabilities, which have become available following the loss of B12 volumes, are triggering interest and could bring future volumes to their sites. Q: You mentioned commercial organization improvement. What does that mean exactly? Do you have concrete elements, please? A: David Sanyal (CEO) acknowledged that past commercial performance was not where it needed to be due to external factors like market headwinds and competition, as well as internal issues like an aging portfolio and suboptimal practices. To address this, they appointed a new Head of Commercial, Frederic Robert, about a year ago. The short-term objectives include strengthening customer engagement, increasing field presence, improving opportunity conversion, and building a more performance-driven organization. They have reorganized regions, brought in new talent, and built a new marketing organization to enhance their value proposition. Q: How does the Brindisi site sale fit into the overall Focus 27 framework plan, and what kind of milestone does it represent? Also, could you provide an update on the closure costs in comparison to the costs planned initially? A: David Sanyal (CEO) stated that the divestment of Brindisi was always part of the Focus 27 plan, with a target to complete it by the end of 2027. The signing with Uve Pharma occurred on July 29, 2026, and they expect closing in the next couple of months. Olivier Falout (CFO) added that they have committed to supporting the site for a two-year transformation period with a total cost of EUR60 million, covering operations, CapEx, and transformation. Q: You expect to pay EUR30 million to the buyer at the end of 2026, followed by EUR15 million in each of '27 and '28. Are there no revenues expected from the site over that period? A: Olivier Falout (CFO) clarified that the site's revenues will belong to the new owner, Uve Pharma, and they do not expect any additional P&L impact except for a small TSA (Transitional Services Agreement) for a few hundred thousand euros. David Sanyal (CEO) added a caveat: for certain products like B12 Salts, Euroapi remains the IP owner, and the new buyer will manufacture them as a CMO, with Euroapi continuing to distribute these products. Q: What level of restructuring costs and impairment charges do you expect to recognize in H2? A: Olivier Falout (CFO) stated that they expect significantly more restructuring costs in H1 than in H2, as they have already accrued for some costs that will occur in H2. The main portion of these costs is already reflected in the books at the end of H1. Q: Could you speak about your liquidity position, which has turned into net debt now, and the cash burn you expect going forward? How much headroom is left in your RCF? A: Olivier Falout (CFO) confirmed that the situation was forecasted and they have substantial headroom. There are no covenants until the end of H1 2027, and the covenant at that time will be set at 4x, leaving plenty of room. David Sanyal (CEO) added that they have a EUR451 million RCF signed with a pool of banks, of which very little has been drawn, and the full-year 2026 cash flow position is expected to be in line with original assumptions. Q: Please explain where we stand in the restructuring process in terms of related one-off costs for idle costs, transformation, and employees. You already said employee-related costs will be lower in H2. Is the remainder completed now and one-offs should decline from here? A: Olivier Falout (CFO) confirmed that this is the plan, as the Focus 27 plan is well organized and largely achieved. They do not expect the same level of transformation costs in the near future, and for 2026, the transformation costs have been mainly performed or accrued by the end of H1. David Sanyal (CEO) added that while they have gone beyond original cost reduction assumptions, the top-line has not developed as planned, so they remain adaptive and will amend plans as needed, with a strong focus on building commercial momentum. Q: Regarding the total closure cost for Brindisi, he understands that EUR60 million transformation costs are planned for the next two years. However, he is not seeing the overall cost picture here in comparison to the initial plan. Can you please clarify? A: Olivier Falout (CFO) explained that they did not disclose the initial cost expectations in detail, but cash-wise, they were prepared to be even more aggressive if necessary. The final SPA contract with Uve Pharma sets the EUR60 million threshold, which represents a good solution for the group regarding the Brindisi site. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus. Net Loss: $194.3 million, or a loss of $1.36 per share, for the fiscal 2026 third quarter ended June 30, 2026. Revenue: Approximately $75 million for the quarter, up from $28 million in the prior year quarter. Commercial Revenue: Approximately $2.4 million from Redemplo sales, more than double the approximately $1 million recorded in fiscal quarter two. Collaboration Revenue: Approximately $26 million from Sarepta, $20 million from Novartis, $25 million from Madrigal, and $1.2 million from Sanofi. Total Operating Expenses: Approximately $245 million, compared to $193 million in the prior year quarter. R&D Expense: Approximately $198 million, up $36 million year-over-year. SG&A Expense: Approximately $47 million, up $16 million year-over-year. Cash and Investments: Approximately $1.6 billion as of June 30, 2026. Common Shares Outstanding: 141.1 million at quarter end. Priority Review Voucher: $215 million payment expected in fiscal fourth quarter following HSR clearance. Warning! GuruFocus has detected 7 Warning Signs with ARWR. Is ARWR fairly valued? Test your thesis with our free DCF calculator. Release Date: August 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive top-line Phase III results from SHASTA-3 and SHASTA-4 studies, with both meeting primary and all pre-specified secondary endpoints, showing median triglyceride reductions of 79% and 81%. Significant reduction in acute pancreatitis events, with a 78% reduction in the broad SHTG population and a 100% reduction in the highest-risk subgroup. Favorable safety and tolerability profile with no new safety signals, no clinically meaningful liver enzyme changes, no hypersensitivity, and no thrombocytopenia signal. Strong commercial momentum in the FCS launch, with prescriptions more than doubling quarter-over-quarter and over 400 unique prescribers. Expansion of regulatory approvals for Redemplo to five geographies, including the EU, Australia, Canada, China, and the U.S., with a unique label covering clinically diagnosed FCS patients in Europe. Acquisition of a priority review voucher to potentially accelerate FDA review of the SNDA for SHTG, potentially bringing the drug to market four months earlier. Robust pipeline progress, including positive interim data for ARO-INHBE in obesity/MASH, full enrollment of the Phase III Yosemite study for zodasiran, and upcoming data readouts for ARO-DiRPA and ARO-MAP-T. Strong balance sheet with approximately $1.6 billion in cash and investments, providing financial flexibility for ongoing development and commercialization. Partnership strategy yielding significant milestones, including a $25 million upfront payment from Madrigal for ARO-PNPLA-3, with potential for up to $975 million in milestones and royalties. Scalable commercial infrastructure designed to support future indications and multiple products, with plans to expand field force to address over 20,000 HCP targets for SHTG. Net loss widened to $194.3 million in the quarter, compared to $175.2 million in the prior year, driven by higher R&D and SG&A expenses. R&D expenses increased by $36 million year-over-year, reflecting continued high investment in clinical development and manufacturing. SG&A expenses rose to $47 million, up from $31 million, due to increased commercial headcount and launch support costs. The acquisition of the priority review voucher for $215 million represents a significant cash outlay, with the return dependent on successful approval and launch. Commercial revenue from Redemplo remains modest at approximately $2.4 million for the quarter, indicating early-stage launch revenue generation. The SHTG market launch is expected to be a slow ramp due to the need for extensive physician and patient education, potentially limiting near-term revenue growth. Uncertainty regarding ex-U.S. market revenue due to factors like MFN and varying reimbursement processes, which could impact international sales. The company is under embargo for detailed SHASTA-3/4 data until ESC, limiting transparency and potentially affecting investor confidence. The Phase III Yosemite study for zodasiran is not expected to complete until mid-2027, with data in the second half of 2027, delaying potential revenue from this program. The company faces competitive pressure in the SHTG market, with a competitor already launched, and the need to justify a premium price for Redemplo. Q: With the SHASTA-3 and SHASTA-4 data in hand, what are the gating factors for the sNDA submission by year-end 2026, and can you comment on any imbalances in liver fat, ALP elevations, or glycemic parameters?A: James Hamilton (CMO & Head of R&D) stated that the team is focused on generating sNDA modules and study reports to file by the end of the year, with a pre-sNDA meeting with the FDA planned. He declined to comment on specific safety data details, citing the embargo until the ESC presentation. Q: What top-line data will you share from the ARO-MAP-T Phase 1 study in September, and what level of target knockdown are you looking for?A: James Hamilton (CMO & Head of R&D) explained that the September readout will be from healthy volunteers, focusing on safety and total tau knockdown as the primary pharmacodynamic biomarker. He reiterated that the benchmark for success remains a 50% to 60% knockdown, a level that has shown clinical improvements in other studies. Q: How will you scale the sales force for the potential SHTG launch, and what is the sequencing over the next several months?A: Andy Davis (SVP & Head of Global Cardiometabolic Franchise) stated that the field force will expand from addressing over 5,000 HCP targets to over 20,000, including specialists and primary care physicians who act like specialists. The final onboarding and optimization of the field force is expected to be completed before the end of the year to prepare for a potential accelerated SHTG launch in Q2 2027. Q: What proportion of patients in SHASTA-3 and SHASTA-4 received an MRI to assess liver fat, and will you continue the SHASTA-5 trial?A: James Hamilton (CMO & Head of R&D) declined to provide details on the MRI subgroup, citing the embargo. He confirmed that there are no plans to terminate the SHASTA-5 study at this time, and it will continue to run without changes until the label is better understood. Q: Which triglyceride responder analysis is more important for establishing plozasiran's value, and will the priority review voucher allow for Part D coverage for most of 2027?A: James Hamilton (CMO & Head of R&D) noted that the 500 mg/dL threshold is key for reducing acute pancreatitis risk, while Chris Anzalone (CEO) added that both 150 and 500 mg/dL thresholds are important, as normalizing a large percentage of patients is an attractive goal. Andy Davis (SVP) stated that the market access team will interact with payers as soon as data is published to prepare for policy development and coverage throughout 2027. Q: How do you see the difference in prescribing between the U.S. and European markets for SHTG, and how much of the $3-4 billion peak sales estimate is U.S.-based?A: Chris Anzalone (CEO) stated that the overwhelming majority of the peak sales estimate is U.S.-based. Andy Davis (SVP) added that European markets are very outcomes-based, making the statistically significant reduction in acute pancreatitis events from the pooled analysis incredibly important for demonstrating value, though the MFN uncertainty makes it difficult to project ex-U.S. revenue. Q: With the Ionis launch underway, how should we think about the right analogs for the SHTG commercial opportunity, and how important are the initial quarters for validating the market size?A: Andy Davis (SVP) emphasized the importance of getting out of the gates quickly, focusing on educating providers and working with payers to accelerate the ramp. He noted a high degree of overlap between FCS and SHTG prescribers, which bodes well for the ramp. Chris Anzalone (CEO) added that SHTG is a large market opportunity, but the launch will be a relatively slow ramp as it is a brand-new market requiring significant education. Q: What is the current weekly prescription run rate for Redemplo, and has the prescription-to-drug conversion rate hit steady state?A: Andy Davis (SVP) confirmed the run rate is approximately 20-30 new prescriptions per week, consistent with prior disclosures. He noted that the market access team is working hard to navigate prior authorizations and appeals, and with new field personnel onboarding this month, he expects an inflection point in both prescriptions and the conversion funnel to patient shipments. Q: Will the SHTG launch be segmented to the highest-risk patients or broader across patients with TGs above 500, and how will this reflect on the commercial build?A: Andy Davis (SVP) stated that while the data supports Redemplo across the spectrum of SHTG patients, the initial focus will be on high-risk patients with the highest unmet need and payer willingness to pay. Chris Anzalone (CEO) added that the data shows it's important to lower triglycerides for anyone above 500 mg/dL, as pancreatitis events occurred in patients below 880 mg/dL, but the broader market will require time and education. Q: How are you thinking about price differential versus the competitor now that you have the SHASTA data?A: Andy Davis (SVP) declined to discuss pricing or contracting strategy but noted the $45,000 WAC is justified by the product's efficacy, safety, and convenience. Chris Anzalone (CEO) confirmed there are no plans to change the price, citing the better safety profile, greater TG reduction, quarterly dosing, lack of liver enzyme monitoring, and simple 25 mg dose as reasons for the premium. Q: What other CNS targets are you excited about if the ARO-MAP-T Phase 1 data is positive?A: James Hamilton (CMO & Head of R&D) stated that the company has many undisclosed targets in its preclinical pipeline. He noted that wholly owned programs will likely not be disclosed until around the time of CTA filing due to the competitive nature of the siRNA space. Q: What are the plans for marketing Redemplo in the newly approved geographies (U.S., Canada, Australia, Europe), and how will revenue be recognized?A: Andy Davis (SVP) explained that Arrowhead is marketing directly in those countries using commercial partners, with the exception of China, where San For the complete transcript of the earnings call, please refer to the full earnings call transcript.