PFE

Pfizer stock has quietly put up a 25.6% gain over the past year, yet broad valuation checks still do not flag it as either clearly cheap or clearly expensive. With mixed signals on value and fresh product news in the background, investors are weighing how much of the recent optimism is already reflected in the share price. The 25.6% 1 year return suggests sentiment toward Pfizer has improved meaningfully, which raises the bar for further upside driven purely by valuation. Approval of Pfizer and BioNTech's updated COVID 19 vaccine and ongoing exposure to markets such as cytotoxic drugs and rare disease treatments can support long term earnings potential, while product concentration, patent cycles and competition in key therapy areas may limit how much investors are willing to pay for that growth. With a value score of 3 out of 6 and multiples that lean toward an overvalued read, the overall picture is a mixed one rather than a clear bargain. The issue now is whether Pfizer's recent share price recovery already reflects the main drivers of its long term valuation or if there is still room for investors to justify paying the current multiples. Compare Pfizer's recent 25.6% 1 year rebound with other companies that also screen as higher quality yet not obviously cheap through 53 high quality undervalued stocks. The P/E multiple is a useful way to think about Pfizer because earnings remain a key focus for many investors when judging large pharmaceutical stocks. Pfizer currently trades at a P/E of 37.8x, which is more than double the Pharmaceuticals industry average of 16.5x and still below the peer group average of 56.4x. That places the stock at a premium to the broader sector even though it does not screen as the richest option among large peers. A fair P/E based on Pfizer’s profile is estimated at 28.4x, which is meaningfully below the current 37.8x level. This indicates that the stock is priced higher than what the tailored model implies given its mix of growth opportunities, margins, scale and risks. Despite fresh attention around the FDA approval of the updated COVID 19 vaccine, the P/E already reflects a confident view and leaves less room for earnings disappointment than for many sector peers. On the P/E multiple alone, Pfizer stock appears overvalued compared with both its tailored fair ratio and the wider Pharmaceuticals industry. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives pick up where the valuation puzzle for Pfizer leaves off by spelling out which assumptions on growth, margins and earnings would need to hold for Pfizer's stock to be worth materially more or less than it is today, and they sit on the company’s Community page. Rather than a single multiple or model output, each narrative lays out its own fair value assumptions so you can later compare them with the company’s actual results. Community views on Pfizer split between a patient growth story and a more cautious read on the transition after the COVID period. Bull case: roughly fairly valued Read the full Bull Case to see why Pfizer could be undervalued Bear case: roughly fairly valued Read the full Bear Case to see why Pfizer could be overvalued Do you think there's more to the story for Pfizer? Head over to our Community to see what others are saying! Pfizer now screens as overvalued on its current P/E compared with both sector averages and its tailored fair multiple, so the easy valuation case looks largely used up. For you as an investor, the key question is whether Pfizer can deliver on the earnings and pipeline expectations that are already baked into this richer multiple. The crux of the bull versus bear debate is how smoothly Pfizer replaces COVID era revenues with newer products while managing patent expiries and competition in core therapies. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include PFE. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

A month has gone by since the last earnings report for Pfizer (PFE). Shares have added about 12.4% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Pfizer due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Pfizer Inc. before we dive into how investors and analysts have reacted as of late. Pfizer reported second-quarter 2026 adjusted earnings per share of 77 cents, which beat the Zacks Consensus Estimate of 68 cents per share. Earnings were flat year over year.Revenues came in at $15.03 billion, up 3% from the year-ago quarter on a reported basis and 1% on an operational basis. Total revenues beat the Zacks Consensus Estimate of $14.45 billion. Growth in Eliquis, Padcev, the Vyndaqel family and Lorbrena offset steep declines in COVID-19 products. International revenues rose 3% on an operational basis to $6.18 billion. U.S. revenues were flat at $8.86 billion.Excluding BioNTech-partnered Comirnaty and Paxlovid, revenues increased 5% operationally. Pfizer’s newly launched and acquired products delivered $3.2 billion in revenues and grew 18% operationally in the quarter. Excluding one-time items recorded in the second quarter of 2025, primarily related to the legacy Seagen in-line portfolio, this operational growth would have been 27%.Adjusted selling, informational and administrative (SI&A) expenses declined 3% (operationally) in the quarter to $3.34 billion due to lower spending in corporate enabling functions. Adjusted R&D expenses rose 12% to $2.73 billion due to higher spending on oncology and obesity pipeline. Pfizer reports its revenues under three broad sub-segments of its Biopharma operating segment — Primary Care, Specialty Care and Oncology. In first-quarter 2026, Pfizer created a new Hospital and Biosimilars Division within its Biopharma segment, moving certain off-patent brands, generic sterile injectables and biosimilars out of Specialty Care and Oncology. Primary Care sales declined 2% on an operational basis to $5.5 billion. Oncology revenues rose 2% to $4.17 billion, while Specialty Care sales increased 7% to $3.35 billion. Hospital and Biosimilars revenues declined 2% to $1.64 billion. In Primary Care, alliance revenues and direct sales from Eliquis increased 19% to $2.43 billion as higher demand trends globally were partially offset by price and generic erosion in some ex-U.S. markets. Eliquis sales beat the Zacks Consensus Estimate of $1.98 billion.Global Prevnar family revenues declined 4% to $1.34 billion and missed the consensus estimate of $1.39 billion. U.S. sales fell 13%, more than offsetting a 10% increase in the international market. U.S. sales declined due to lower vaccination rates in the pediatric and adult indications. International sales rose due to continued increases in demand in both the adult and pediatric indications.Direct sales and alliance revenues from partner BioNTech for Comirnaty were $261.0 million in the quarter, down 34% year over year, missing the consensus estimate of $278 million. The decrease reflected a smaller favorable adjustment to the returns provision and lower U.S. utilization following narrower vaccination recommendations.Paxlovid revenues plunged 95% to $21 million due to lower COVID-19 infections and reduced government purchases in some international markets. Sales fell well short of the consensus estimate of $119 million.Nurtec ODT/Vydura contributed $421.0 million in the quarter, up 17% year over year, driven by strong demand and prescription growth. Among the new products, Pfizer’s RSV vaccine, Abrysvo, recorded sales of $208 million, up 43% on an operational basis, driven by launch uptake and favorable timing of deliveries in some international markets and favorable buying patterns in the United States. In Oncology, Ibrance revenues were flat at $1.06 billion, exceeding the Zacks Consensus Estimate of $1.05 billion.Padcev sales climbed 23% to $667 million and surpassed the consensus estimate of $661 million. Padcev benefited from strong demand trends mainly due to market share gains in first-line metastatic urothelial cancer and launch momentum from the new muscle-invasive bladder cancer indication. Xtandi alliance revenues declined 6% to $534 million. Lorbrena revenues rose 37% to $354 million, driven by market share gains in the first-line ALK-positive metastatic NSCLC treatment setting in the United States, China, and some other international countries. Adcetris sales fell 23% to $196 million. Inlyta revenues decreased 12% to $218 million. Braftovi/Mektovi revenues rose 23% to $223 million.New drug, Elrexfio, generated sales of $89 million in the quarter, up 5% year over year. Vyndaqel family revenues increased 8% to $1.76 billion, slightly exceeding the Zacks Consensus Estimate of $1.75 billion. The Vyndaqel family includes global revenues from Vyndaqel as well as revenues from Vyndamax in the United States and Vynmac in Japan. Growth reflected continued patient diagnosis and improved access in international markets, along with U.S. market expansion, which partially offset the impact of price erosion as a result of new payer contracts in the United States.Xeljanz sales declined 23% to $251 million, while Enbrel revenues fell 10% to $142 million. Cibinqo sales rose 34% to $94 million. Within Hospital and Biosimilars, oncology biosimilar sales increased 1% to $359 million, and Inflectra revenues rose 23% to $171 million. Pfizer raised the lower end of its 2026 revenue guidance, backed by continued strong performance of its new and acquired products. The company now expects revenues between $60.5 billion and $62.5 billion, compared with the previous range of $59.5 billion to $62.5 billion. The range indicates a decline from 2025 revenues of $62.6 billion due to lower revenues from COVID products and loss of revenues from the upcoming patent cliff. The revised outlook reflects approximately $1.5 billion of better-than-expected non-COVID product performance, partly offset by a $1 billion reduction in expected COVID-19 product revenues. Pfizer now expects around $4 billion from COVID-19 products in 2026, lower than the prior expectation of around $5 billion.Paxlovid demand is expected to be limited due to low COVID infection levels. Meanwhile, most sales of Comirnaty are expected later in the year, in line with the seasonal vaccination period.The adjusted earnings guidance was reaffirmed at $2.80-$3.00 per share. However, the guidance now absorbs a 10 cents per share charge related to its licensing deal with Chinese biotech Innovent Biologics that will be recorded in the third quarter of 2026.Adjusted gross margin is expected to be in the mid-70s range, similar to the past several years. Adjusted R&D expenses are expected to be in the range of $10.5 billion to $11.5 billion in 2026, while adjusted SI&A spending is targeted between $12.5 billion and $13.5 billion. The adjusted effective tax rate is expected to be approximately 15% in 2026. Pfizer also said it expects additional cost savings of $2.5 billion, which it expects to realize from 2027 through 2029.Pfizer remains on track to achieve approximately $5.7 billion in net savings from its ongoing cost realignment program by the end of 2026 and has expanded the initiative with an additional $1 billion in expected SG&A savings through 2029, bringing total savings from the program to about $6.7 billion through 2029. Separately, the company has expanded its multi-year manufacturing optimization program, which is now expected to generate approximately $3 billion in cumulative cost-of-goods savings by 2029. Overall, Pfizer expects approximately $9.7 billion in total net savings from its productivity enhancement initiative through 2029. In the past month, investors have witnessed a downward trend in estimates review. The consensus estimate has shifted -8.39% due to these changes. At this time, Pfizer has a average Growth Score of C, a grade with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a grade of B on the value side, putting it in the second quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Pfizer has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Pfizer is part of the Zacks Large Cap Pharmaceuticals industry. Over the past month, AbbVie (ABBV), a stock from the same industry, has gained 6.3%. The company reported its results for the quarter ended June 2026 more than a month ago. AbbVie reported revenues of $16.99 billion in the last reported quarter, representing a year-over-year change of +10.2%. EPS of $3.65 for the same period compares with $2.97 a year ago. For the current quarter, AbbVie is expected to post earnings of $3.86 per share, indicating a change of +107.5% from the year-ago quarter. The Zacks Consensus Estimate has changed -0.5% over the last 30 days. AbbVie has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D. 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 Pfizer Inc. (PFE) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

With central banks lifting interest rates to tackle inflation, investors are hunting for themes that do not rely purely on cheap money to grow. Artificial intelligence in healthcare is one such story. It focuses on software and data rather than heavy assets. This article highlights three Transformative AI Healthcare Stocks from our screener that apply algorithms to diagnostics, treatment decisions, and hospital efficiency. The three stocks that follow are only a starting sample from this theme. The full screen surfaced 35 more companies with equally compelling narratives that are not covered in the article. To go deeper into this opportunity, analyze and identify your own highest conviction ideas directly in the Transformative Artificial intelligence (AI) Healthcare Stocks screener. Pfizer is one of the largest global biopharma companies, discovering, developing, manufacturing and selling treatments across internal medicine, vaccines, oncology, rare diseases and biosimilars. Its direct link to transformative AI comes from the collaboration with Boltz, PBC to build biomolecular AI foundation models aimed at speeding up drug discovery and sharpening precision in how new therapies are designed. The Global Biopharmaceuticals Business generates about US$62.3b in revenue, with only a small part of that tied directly to AI efforts, and Pfizer’s market cap is about US$162.2b. Investors looking at Pfizer get access to a broad late stage pipeline in areas such as oncology and obesity, as well as a clear AI angle through its biomolecular modeling work with Boltz that targets faster, more precise drug development. At the same time, there are real watchpoints, including a heavy patent expiry cycle, regulatory pressure on drug pricing and a recent large one off loss that clouds profit trends. The interest lies in whether this AI enabled R&D push, combined with ongoing cost saving efforts and a strong global commercial footprint, can turn that complexity into a more efficient, higher value portfolio over the rest of the decade. Pfizer’s AI fueled drug design push could reshape a US$162.2b giant; however, patent cliffs and pricing pressure still loom large. Get the fuller picture with the 2 key rewards and 4 important warning signs Tempus AI runs a healthcare data and diagnostics platform that links genomic testing, clinical records and imaging with its Next AI and Algos tools to support precision diagnostics, treatment decisions and trial matching. The company generates about US$1.4b in revenue from Medical Labs and Research, largely tied to diagnostics services such as NGS tests and pathology, which in turn feed its AI models and data products. Tempus AI has a market cap of roughly US$11.4b. Investors watching how AI is reshaping diagnostics may want Tempus AI on their radar. The company combines a growing diagnostics franchise with a large de identified data asset and AI tools that support oncology, cardiovascular risk detection and trial matching, helped by collaborations with big pharma and leading hospitals. At the same time, Tempus is still loss making, carries meaningful debt and has seen insider selling, so expectations around AI driven growth and a move toward profitability within a few years carry execution risk. The key question is whether the data flywheel and higher margin data and application revenue can turn today’s complex story into a more durable healthcare AI platform over time. Tempus AI is building an accelerating data and diagnostics engine, yet the real story sits in how its losses, debt and insider selling line up against the 1 key reward and 2 important warning signs Medtronic is a large global medical device company that supplies hospitals and specialists with everything from cardiac implants and neuromodulation systems to surgical tools and insulin pumps, and now layers AI into key parts of that portfolio. Its clearest tie to transformative AI is the surgical video and analytics platform in the Medical Surgical Portfolio, which uses machine learning on intraoperative video to support decisions and smoother workflows, alongside AI enabled remote monitoring software in cardiovascular care. Medtronic has a market cap of about US$116.0b. Medtronic gives you exposure to AI inside the operating room and at the bedside, where its video analytics, robotic assisted surgery and remote monitoring tools aim to improve how complex procedures are done and how chronic conditions are managed. The potential prize is growth in higher value, data rich platforms as procedure volumes and digital health adoption move forward, backed by a large installed base and a long track record in devices. The catch is that underperforming segments, margin pressure and execution risk around big launches such as Hugo robotics and new diabetes systems could affect returns if adoption is slower than expected. For investors willing to watch those fault lines closely, Medtronic’s AI driven shift could be an important factor in how the next few years play out. Medtronic’s AI push in the operating room could be more than hype, particularly if higher value platforms shift the earnings mix. Scan the analyst forecasts for Medtronic to see what expectations might be missing. Fresh stock themes move fast. By the time most investors notice the breakout momentum, the best entry points can be gone. Scan these curated ideas before the crowd and review them in detail. Hunt for early-stage stories with real balance sheet strength by reviewing the curated 22 elite penny stocks with strong financials before momentum starts and prices move higher. Track where real earnings power meets AI momentum by checking the hand picked 75 profitable AI stocks that aren't just burning cash while expectations are still under the radar. Target reliable cash flows and payout resilience by scanning the curated 12 dividend fortresses before yields change and income opportunities become more widely followed. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Nvidia (NVDA) has done it again, delivering one of the most remarkable quarterly earnings reports I can recall. Second-quarter revenue surged 106% year-over-year to $96.2 billion, with gross margins of roughly 75% and net income of $59.7 billion. Nvidia also returned $25 billion to shareholders during the quarter, while growth expectations for the coming year moved sharply higher. The numbers themselves are extraordinary. But what makes this quarter historic is not simply the growth rate. It is the combination of growth and scale. There have been other periods when enormous companies posted comparable growth, but nearly all came with important caveats. Oil majors roughly doubled nominal revenue during the 1970s, but much of that was driven by commodity prices and ultimately reversed. Pfizer nearly doubled from a $42 billion revenue base during the pandemic, but that was largely a one-time vaccine windfall. Amazon added $106 billion in revenue in 2020, but did so at a fraction of Nvidia’s profitability. Nvidia is now approaching a $400 billion annual revenue run rate, equivalent to roughly 1.3% of US GDP. There is historical precedent for an individual company reaching that kind of economic scale, General Motors approached 3% of GDP in the 1950s, but it took GM 50 years to get there. And that gets to the larger question surrounding the company and the AI boom. The best historical comparison for Nvidia may not be another fast-growing technology company. It may instead be the dominant capital-goods suppliers behind previous investment booms: locomotive and rail-equipment manufacturers in the nineteenth century, telecom equipment vendors during the late 1990s or the suppliers behind other massive infrastructure buildouts. That distinction matters. Nvidia's revenue ultimately depends on the capital-spending decisions of a relatively concentrated group of enormous customers. When spending is accelerating, the economics can be spectacular. But if those customers suddenly pull back, growth can slow very quickly. Jensen Huang clearly understands that this is the central question facing Nvidia. That is why so much of the earnings call focused not simply on demand for GPUs, but on the economics customers are generating from them. “Its tokens are productive and profitable. Now, compute is revenue.” That claim is enormously important because it gets directly at the biggest concern surrounding the AI boom: Are companies actually making money on all of this infrastructure? During the telecom bubble, enormous amounts of fiber were laid in anticipation of future demand, only for much of it to sit unused for years. If AI infrastructure were following the same path, Nvidia's extraordinary growth would look considerably more vulnerable. So far, however, the evidence increasingly suggests otherwise. Dylan Patel of SemiAnalysis estimates that compute can rent for roughly $13 million per megawatt, while leading AI labs can generate as much as $50 million per megawatt in revenue from that infrastructure. Just as importantly, Patel notes that much of today's compute capacity is contracted before it is even built, which is close to the opposite of a speculative overbuild. Only a year ago, many AI companies were losing money on every token they served. Today, inference economics have improved substantially, utilization remains extremely high and the largest AI companies continue to demand more compute than the industry can readily provide. That does not mean the AI boom is without risk. If anything, the constraint may increasingly shift from demand to financing. Patel estimates the broader AI infrastructure buildout could exceed $11 trillion through 2029, with trillions potentially requiring outside credit. At some point, the sheer scale of that borrowing could push capital costs higher and slow the pace of investment. But that is a very different concern from the idea that AI infrastructure is being built without customers or economic value behind it. For now, the evidence continues to suggest that the GPUs Nvidia is selling are being heavily utilized, generating revenue for their owners and increasingly producing attractive economics. That makes today's AI buildout look considerably different from the dark fiber of the dot-com era, and gives Nvidia's extraordinary growth much stronger fundamental backing. Perhaps the most remarkable part of the Nvidia story is that, despite this growth, the valuation is not particularly extreme. NVDA currently trades around 23.5x forward earnings and carries a Zacks Rank #2 (Buy). Following a quarter like this, I would also expect analysts to continue raising earnings estimates, potentially providing another tailwind for the Zacks Rank. The technical setup is equally encouraging. NVDA shares have spent much of the last year moving through two major consolidations. As shown in the chart, the stock is once again pressing against resistance near its previous highs and appears to be attempting another breakout. With Nvidia now providing further confirmation of both the extraordinary demand for its GPUs and the profitability being generated by AI compute, a successful breakout from this consolidation could mark the beginning of another meaningful advance. Image Source: TradingView There are still legitimate risks, as there always are. Nvidia depends heavily on an extraordinary capital-spending cycle among a relatively small number of customers. Financing requirements are becoming enormous, memory costs could pressure margins and eventually the economics of the AI buildout will have to justify trillions of dollars in investment. But the evidence available today continues to move in Nvidia's favor. Demand remains exceptional, utilization is high and AI infrastructure increasingly appears capable of producing attractive economics for its owners. Nvidia's growth remains almost without historical precedent, and yet the stock trades at a valuation that looks surprisingly reasonable relative to that growth. The AI investment cycle will not continue at this pace forever. No capital-spending boom does. But Nvidia's latest quarter offers little evidence that the cycle is approaching its end. For now, it remains difficult to make a compelling case against owning NVDA. 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 NVIDIA Corporation (NVDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Xtandi® (enzalutamide) is indicated as monotherapy for the treatment of patients with non-metastatic prostate cancer (nmCSPC) at high risk of metastasis and for the treatment of patients with metastatic prostate cancer (mCSPC) who are maintaining treatment with a GnRH analogue. Global sales for Xtandi® (marketed by Astellas Pharma and Pfizer) reached approximately $8 billion and $6 billion globally in 2024 and 2025, respectively. The main composition of matter patents for enzalutamide (sold as Xtandi) expire in 2026 in Europe and 2027 in the United States (Patent US9126941 & Patent US8183274) with a U.S. price cut scheduled to begin in 2027. New data from a VCaP prostate cancer cell line that features high expression of wild-type androgen receptors, demonstrated that a combination of Aramchol with enzalutamide resulted in 3–4-fold increase in cell death compared with enzalutamide as a single agent. RAMAT-GAN, Israel, Aug. 17, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic and oncology diseases, today announced significant results from a pre-clinical study of a combination of Aramchol and Xtandi® (enzalutamide) for prostatic cancer. Prostate cancer is the second most common cancer in men worldwide and remains a significant cause of cancer-related morbidity and mortality. Androgen signaling plays a central role in the development and progression of prostate cancer. For this reason, anti-androgen therapy and related androgen axis-targeting approaches represent important modalities in the treatment of prostate cancer. Despite the availability of anti-androgen therapies, there remains a need for improved treatment regimens that may be used alone or in combination with existing anti-androgen therapies, including in patients having resistant, recurrent, advanced, metastatic, or otherwise difficult-to-treat prostate cancer. Recent publications indicate that prostate cancer tumors can adapt to SoC treatments such as enzalutamide by altering their lipid metabolism. Both enzalutamide-sensitive and resistant cells depend on this lipid desaturation pathway. Combining enzalutamide (an androgen receptor blocker) with an SCD1 inhibitor blocks this lipid synthesis and desaturation, potentially leading to decreased cell viability, and delayed development of drug resistance. The data we present today, demonstrate that a combination of Aramchol (an SCD1 inhibitor) with enzalutamide resulted in 3–4-fold increase in cell death (compared with enzalutamide as a single agent) and that the interaction gets stronger, the longer the drugs are on board. The VCaP prostate cancer cell line features high expression of wild-type androgen receptors, the clinically relevant AR-V7 splice variant, and the TMPRSS2-ERG gene fusion, sourced from a vertebral metastasis of a 59 year old Caucasian mCSPC patient. Previously Galmed demonstrated that Aramchol synergistically interacts with docetaxel (Taxotere®) a potent, semisynthetic chemotherapy medication, to cause greater than additive killing in a whole range of tumor types where docetaxel is approved, including prostate cancer cells. The results from those studies support the further evaluation of Aramchol in combination with approved prostate cancer therapies, including combining Aramchol with enzalutamide (with or without GnRH analogue) and as the anti-androgen interaction starts to wear off, switch to a combination of Aramchol with docetaxel. Allen Baharaff, Galmed's Co-founder and CEO, commented: "The data we present today is a result of our research work in prevention of drug resistance to blockbuster agents in oncology (as previously reported in our earlier press releases). Global sales for Xtandi® (marketed by Astellas Pharma and Pfizer) reached approximately $8 billion and $6 billion globally in 2024 and 2025 (accounting for roughly 4% of Pfizer's total revenue). The main composition of matter patents for enzalutamide (sold as Xtandi®) expire in 2026 in Europe and 2027 in the United States (Patent US9126941 & Patent US8183274). A combination of Aramchol and enzalutamide could potentially become a lifecycle management for Xtandi® in light of the U.S. price cut scheduled to begin in 2027 as well as a key differentiating factor for any generic competitor trying to capture a portion of this multibillion-dollar market. Galmed is planning to initiate discussions with potential partners based on a patent application for the combination that has been recently submitted". About Galmed Pharmaceuticals Ltd.: Galmed Pharmaceuticals Ltd. is a biopharmaceutical and medical device company focused on developing innovative solutions for gastrointestinal, cardiometabolic and oncology indications. The Company is advancing Aramchol and related product candidates for GI oncology and other potential indications, while also exploring novel targeted delivery technologies and therapeutic approaches for cardiometabolic diseases. In addition, through its wholly owned subsidiary, Colospan Ltd., the Company is developing and commercializing CG-100, a medical device designed to address complications associated with colorectal surgery. Galmed's strategy is to build a diversified platform that leverages its expertise in drug development, medical devices and gastrointestinal disease to address significant unmet medical needs. Forward-Looking Statements: Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to how a combination of Aramchol and enzalutamide could potentially become a lifecycle management for Xtandi® in light of the U.S. price cut scheduled to begin in 2027 as well as a key differentiating factor for any generic competitor trying to capture a portion of this multibillion-dollar market and how Galmed is planning to initiate discussions with potential partners based on a patent application for the combination that has been recently submitted. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, our inability to recognize the anticipated benefits of the acquisition of Colospan; expectations with respect to future performance and growth of Colospan; the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of CG-100, Aramchol or any other medical device or product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to CG-100, Aramchol or any other medical device or product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of CG-100, Aramchol and any future medical devices or product candidates; our ability to comply with all applicable post-market regulatory requirements for CG-100, Aramchol, or any other medical device or product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for CG-100, Aramchol, or any medical device or other product candidate; third-party payor reimbursement for CG-100, Aramchol, or any other medical device or product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of CG-100 Aramchol or any other medical device or product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of CG-100, Aramchol or any other medical device or product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our CG-100 or product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 31, 2026 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. View original content to download multimedia:https://www.prnewswire.com/news-releases/galmed-announces-first-time-results-in-prostate-oncology-studies-aramchol-demonstrates-3-4-fold-increase-in-cell-death-compared-to-enzalutamide-xtandi-alone-in-prostate-cancer-models-302852805.html

Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. Pfizer stock has delivered a roughly 28% decline over the past five years, yet recent gains and a mixed set of valuation checks mean the current price is not an obvious bargain or clear bubble. With fresh product news and shifting expectations around its portfolio, investors are weighing whether the recent rebound leaves enough room for attractive long term returns. The share price is down about 28% over five years. This points to a company that has yet to fully reward long term holders despite a stronger showing in the last year. Progress on Pfizer and Valneva's Lyme disease vaccine candidate can support confidence in future cash flows, while legal and product related risks such as the Chantix settlement may limit how much of a premium the market is willing to put on the stock. The broader checks give Pfizer a mixed read on value, with the company scoring 3 out of 6 on Simply Wall St's valuation framework, so it does not stand out as clearly cheap or clearly expensive. The issue now is whether the current price for Pfizer properly reflects that mixed valuation picture or pushes the stock too far in either direction. Find out why Pfizer's 14.0% return over the last year is lagging behind its peers. The P/E ratio is a useful way to look at Pfizer because earnings are still the main anchor for how investors value this large pharmaceutical business. Pfizer currently trades on a P/E of 35.2x, which is more than double the pharmaceuticals industry average of 16.9x and also below the peer group average of 52.5x. That places the stock at a premium to the broader sector, even if it does not sit at the very top of the peer range. Simply Wall St's fair P/E for Pfizer, which adjusts for its specific growth outlook, margins, size and risk profile, is 24.6x. The current 35.2x multiple is therefore meaningfully higher than this tailored estimate. Despite the recent Lyme disease vaccine progress and stronger non Covid revenue mix, the P/E still indicates investors are paying a higher valuation for Pfizer shares relative to what this framework suggests is justified. On this P/E yardstick, Pfizer stock appears overvalued. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives pick up where Pfizer's valuation puzzle leaves off and spell out which combinations of future growth, margins and earnings would need to play out for the stock to be worth meaningfully more or less than today's price. Rather than focus on a single multiple or model output, each narrative lays out the assumptions behind its view of fair value so you can compare those expectations with Pfizer's reported results over time. Community views on Pfizer sit on opposite sides of the fence, with one camp leaning into the pipeline story and the other focused on pressure from pricing and patents. Bull case: 8% undervalued Read the full Bull Case to see why Pfizer could be undervalued Bear case: 7% overvalued Read the full Bear Case to see why Pfizer could be overvalued Do you think there's more to the story for Pfizer? Head over to our Community to see what others are saying! Pfizer looks overvalued on current market multiples, which suggests the recent optimism already prices in a fair amount of good news. With broader valuation checks sitting in a mixed range, the stock does not screen as a clear bargain or an obvious bubble. The key question from here is whether Pfizer can deliver enough durable earnings growth from its pipeline to make the current premium feel routine rather than stretched, especially in the face of pricing and legal pressures highlighted by recent events. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include PFE. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Interested in Valneva SE Sponsored ADR? Here are five stocks we like better. First-half performance weakened: Revenue fell to €65.8 million from €97.6 million, while the operating loss widened to €49.9 million, partly due to IXCHIQ-related provisions and inventory impairments. Valneva maintained its 2026 outlook for product sales of €135 million–€150 million and total revenue of €145 million–€160 million, supported by €121.5 million in cash and restructuring measures expected to improve second-half cash flow. Lyme vaccine regulatory progress remains pivotal: Pfizer has filed with the European Medicines Agency and expects regulatory decisions within 12 months, with potential financial self-sustainability beginning in 2027 if the vaccine is approved and commercialized. Novavax’s dispute resolution and upcoming earnings call Valneva (NASDAQ:VALN) reported lower first-half revenue and wider losses for 2026, while maintaining its full-year sales outlook and emphasizing its cash position, restructuring measures and expectations for regulatory progress on its Lyme disease vaccine candidate with Pfizer. CEO Thomas Lingelbach said the company ended the period with more than €120 million in cash following disciplined cash management, a recent offering and a restructuring program that included workforce reductions, project reprioritization and a focus on core operations. Cash at June 30 was €121.5 million, compared with €109.6 million at the end of 2025. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Product sales totaled €64 million in the first half, down from €91 million a year earlier. Total revenue fell to €65.8 million from €97.6 million, largely reflecting lower product sales and the absence of a prior-year upfront payment tied to a licensing agreement with the Serum Institute of India for Valneva’s single-shot chikungunya vaccine. CFO Peter Bühler said IXIARO sales declined to €44 million from €54.7 million. The decrease reflected a transition to a new German distributor in January, the timing of deliveries to the U.S. Department of Defense and a €1.5 million adverse foreign-exchange effect. The company expects to sign a new U.S. Department of Defense supply contract in the coming months and begin recognizing sales under that agreement in the second half. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand DUKORAL sales declined to €14.7 million from €17.4 million. The prior-year period benefited from one-time doses supplied to Mayotte during a cholera outbreak, while 2026 sales were affected by the German distributor transition and some weakening in travel markets due to geopolitical factors. IXCHIQ sales were €4.4 million, compared with €7.5 million in the first half of 2025. While the current period included the first shipment of drug substance to Brazilian partner Instituto Butantan, the prior-year period included 40,000 doses sold to La Réunion during a chikungunya outbreak and U.S. travel sales. Bühler said Valneva is evaluating IXCHIQ’s future commercial strategy, including a potential greater focus on endemic markets because of slow travel-market uptake. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Third-party product revenue fell to €1 million from €11.4 million after distribution agreements ended in December 2025 without renewal. Valneva reported an operating loss of €49.9 million for the first half, compared with a €16.8 million loss a year earlier. Adjusted EBITDA loss widened to €40.1 million from €6 million. Cost of goods and services rose to €59.5 million from €47.2 million. Bühler attributed the increase partly to exceptional IXCHIQ-related charges, including a €9.7 million provision for cancellation fees on external manufacturing commitments and a €4.5 million non-cash impairment on excess inventory following lower-than-expected sales. Research and development spending declined to €30.2 million from €32.4 million due to reprioritization and rescheduling of activities. Marketing and distribution expense fell to €13.5 million from €20.3 million, while general and administrative expense declined to €15.4 million from €19 million. The first-half figures included €3.2 million in one-time restructuring costs. The company expects its restructuring actions to produce favorable profit-and-loss and cash-flow effects in the second half and beyond. Bühler said Valneva expects gross margin to improve in the second half as first-half nonrecurring items do not repeat, though full-year gross margin may remain below the prior year’s level. Lingelbach said Pfizer continues to be positive about the outlook for the Lyme disease vaccine candidate, referred to during the call as LB6V. Pfizer has said it expects regulatory decisions within the next 12 months, according to Valneva. Valneva said the vaccine showed point efficacy above 70% and a favorable safety profile, though the lower bound of the 95% confidence interval missed the targeted threshold in one analysis. Lingelbach noted that the lower confidence-interval bound exceeded 20% in a second prespecified analysis and said the company believes the totality of evidence, disease burden and potential health-economic benefit support the program. During the question-and-answer session, Lingelbach confirmed Pfizer has filed with the European Medicines Agency and said European and U.S. regulatory activities are independent processes. He said he expects Europe could move first, while Pfizer continues to work with the FDA in support of a planned biologics license application submission. Valneva shares development costs with Pfizer through licensure under the existing agreement. Lingelbach said any further investment in the program after licensure, including potential post-marketing work, would be addressed later and is not currently covered by the contract. For IXCHIQ, Valneva is supporting a Brazilian pilot vaccination campaign in adults ages 18 to 59, where more than 50,000 people have been vaccinated. Lingelbach said Brazil’s government aims to vaccinate at least 100,000 people as part of active pharmacovigilance before broader public-health deployment. Butantan’s locally manufactured version of the vaccine has been approved and is expected to be incorporated into Brazil’s public health system. The company also expects results in coming months from two studies of its in-licensed tetravalent Shigella vaccine candidate: an adult controlled human infection study and an infant immunogenicity and safety study. Lingelbach said Valneva plans to determine next development steps based on the data, including whether potential optimization of dose, schedule or formulation is needed. Valneva reaffirmed 2026 guidance for product sales of €135 million to €150 million and total revenue of €145 million to €160 million. Management said the commercial business is expected to continue generating positive cash flow. Lingelbach corrected an earlier statement on timing for potential financial self-sustainability, saying the company sees potential to reach that position beginning in 2027, subject to Lyme vaccine approval and subsequent commercialization by Pfizer. Valneva SE is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases. Headquartered in Saint-Herblain, France, the company applies inactivated whole-cell and recombinant technology platforms to address public health needs. Valneva's research and development efforts span a range of viral and bacterial pathogens, with an emphasis on travel-related and emerging infectious diseases. Among its marketed products, Valneva offers IXIARO®/JESPECT® for the prevention of Japanese encephalitis and DUKORAL® for the prevention of cholera and diarrhea caused by enterotoxigenic Escherichia coli. 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 "Valneva Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Total product sales of €64.0 million Solid cash position of €121.5 million as of end June 2026 Regulatory decisions for Lyme disease vaccine candidate expected in the next twelve months2 Lyon (France), August 13, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its condensed consolidated financial results for the first half of the year ended June 30, 2026, provided key corporate updates, and reaffirmed its financial guidance for 2026. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company’s website (Financial Reports – Valneva). Valneva will provide a live webcast of its half year 2026 results conference call beginning at 3 p.m. CEST / 9 a.m. EDT today. This webcast will also be available on the Company’s website. Please refer to this link: https://edge.media-server.com/mmc/p/zd7jniit/lan/en First-half 2026 Financial Update Total revenues were €65.8 million, including €64.0 million in product sales, compared with €97.6 million and €91.0 million, respectively, in the first half of 2025. The year-over-year decrease primarily reflects the planned wind-down of third-party sales (down €10.5 million versus the first half of 2025) and the expected phasing of product sales, including the distribution transition in Germany and timing of IXIARO® shipments to the U.S. Department of Defense (DoD). Cash position was €121.5 million as of June 30, 2026, compared with €109.7 million as of December 31, 2025. This strong cash position reflects the positive impact of restructuring initiatives, disciplined cash management and €37 million in gross proceeds from the successful reserved offering completed in the second quarter of 2026. Net loss of €63.3 million compared with a net loss of €20.8 million in the first half of 2025, reflecting lower gross margin due to lower sales and manufacturing volumes as well as one-off impacts on cost of goods sold, including IXCHIQ®-related contract termination costs and inventory write-offs. Financial Outlook Despite the continued adverse impact of the geopolitical environment on travel, Valneva reaffirmed its 2026 guidance with expected product sales of €135 million to €150 million and total revenues of €145 million to €160 million. Product gross margins are expected to improve in the second half of the year following one-off effects in the first half of 2026 Valneva successfully implemented a global restructuring initiative4 to reduce its cash burn through a significant workforce reduction, the reprioritization and rescheduling of R&D activities and the streamlining of its global operations. As part of this initiative, the Company also agreed to sell its Nantes site in France for €6.2 million. A preliminary sale agreement has been signed with Nantes Métropole, and the transaction is expected to close in September 2026. Peter Bühler, Valneva’s Chief Financial Officer, commented, “Our focus over the past few months, following the Lyme VALOR results has been to restructure and refocus our operations. The successful financing completed in April has enabled us to build and maintain a strong cash position, allowing us to prioritize resources on our core business and key strategic priorities while preserving the flexibility to accelerate growth should the Lyme program progress successfully toward licensure and commercialization.” Financial Information(Unaudited results, consolidated per IFRS) Clinical Stage ProgramsLYME DISEASE VACCINE CANDIDATE – LB6V (formerly VLA15) Regulatory decisions expected in the next twelve months In March 2026, Valneva and Pfizer announced topline results from the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial (NCT05477524) evaluating their investigational six valent OspA-based Lyme disease vaccine candidate LB6V6.Since then, Pfizer has been engaging with regulatory authorities to align on potential pathways to licensure and has expressed optimism regarding the vaccine candidate's regulatory approval prospects7. Regulatory decisions are expected in the next twelve months8.LB6V is currently the only Lyme disease vaccine candidate in late-stage clinical development. The program has received PRIME designation from the European Medicines Agency (EMA) and Fast Track designation from the U.S. Food and Drug Administration (FDA).If approved, LB6V has the potential to address a significant unmet medical need, with more than 80 million people in the United States and over 200 million people in Europe estimated to live in areas at elevated risk of Lyme disease. CHIKUNGUNYA VACCINE - IXCHIQ® / VLA1553Ongoing post-marketing commitments activities, including Pilot Vaccination Campaign in Brazil Several post-marketing commitments activities for IXCHIQ® are ongoing. These include the ongoing Pilot Vaccination Strategy (PVS) in Brazil. This is the first large-scale public vaccination campaign using IXCHIQ® in a real-world setting, conducted by the Brazilian Ministry of Health with support from Valneva and its local partner, Instituto Butantan. To date, approximately 50,000 adults aged 18 to 59 years have already been vaccinated as part of this campaign.The PVS, together with several studies that are ongoing or in preparation9,10,11,12, will serve as the basis for current and planned post-marketing Phase 4 studies evaluating the effectiveness and safety of IXCHIQ® to generate real-world evidence in larger and more specialized populations. SHIGELLA VACCINE CANDIDATE – S4V2First Phase 2 results expected shortly S4V2 is the world’s most clinically advanced tetravalent vaccine candidate against shigellosis, the second leading cause of fatal diarrhea worldwide. Two clinical trials of S4V2, a Phase 2 infant safety and immunogenicity trial13, and a Phase 2b Human Challenge trial (CHIM)14, sponsored by LimmaTech Biologics AG, are ongoing. Results from both studies are expected in the third quarter of 2026. Based on the outcome of these studies and the future R&D strategy, Valneva will determine the appropriate next steps, including whether to assume responsibility for the vaccine candidate's late-stage clinical development15.No approved multivalent Shigella vaccine is currently available outside of Russia or China, and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)16. In October 2024, the U.S. FDA granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need17. The global market opportunity for a vaccine against Shigella is estimated to exceed $500 million annually18. First-Half 2026 Financial Review                         (Unaudited, consolidated under IFRS) Revenues Valneva’s total revenues were €65.8 million in the six months ended June 30, 2026, compared to €97.6 million for the same period in 2025. The decrease was primarily attributable to the planned discontinuation of the majority of third-party sales, the expected phasing of product sales, including the timing of IXIARO® shipments to the U.S. DoD, the distributor transition in Germany as well as non-recurring outbreak-related sales of DUKORAL® and IXCHIQ® recorded during the first half of 2025 that did not repeat in 2026. Other revenues, including revenues from collaborations, licensing and services, amounted to €1.8 million in the first half of 2026 compared to €6.5 million for the same period in 2025, which included revenues recognized under the exclusive license agreement with the Serum Institute of India for IXCHIQ®, which was terminated in 2025. Product Sales Total product sales amounted to €64.0 million in the first half of 2026, compared to €91.0 million in the first half of 2025. In line with Valneva’s strategy and prior communications, third-party distribution activities have significantly decreased following the expiration of the Company’s main distribution agreement in 2025. Consequently, third-party product sales decreased by €10.5 million, or 91.6%, to €1.0 million in the first half of 2026 and are expected to represent less than 5% of product sales by the end of the year.Valneva’s commercial portfolio comprises three vaccines: IXIARO®/JESPECT®, DUKORAL® and IXCHIQ®. Japanese Encephalitis Vaccine IXIARO®/JESPECT® Sales of IXIARO®/JESPECT® were €44.0 million in the first half of 2026, compared with €54.7 million in the first half of 2025. The year-over-year comparison primarily reflects the transition to a new distributor in Germany in January 2026 as well as the product sales phasing, notably the timing of deliveries to the U.S. DoD. Deliveries under the contract signed in January 2025 continued during the period, and Valneva expects to make additional IXIARO® deliveries to the DoD during the remainder of 2026, including under a new contract expected in the third quarter. Foreign currency fluctuations had an adverse impact of €1.5 million on IXIARO®/JESPECT® sales during the first half of 2026. Cholera / ETEC19-Diarrhea Vaccine DUKORAL® DUKORAL® sales were €14.7 million in the first half of 2026, compared with €17.4 million in the first half of 2025. The prior-year period benefited from one-time sales associated with the supply of vaccine doses to Mayotte in response to a cholera outbreak. Sales in the first half of 2026 were also affected by the transition to a new distributor in Germany in January 2026. Existing inventory held by the previous distributor remained sufficient to meet market demand during the period, temporarily reducing product shipments, while the geopolitical situation continued to adversely affect travel. Deliveries under the new distribution arrangement are gradually resuming. Foreign currency fluctuations had an adverse impact of €0.4 million on DUKORAL® sales during the first half of 2026. Chikungunya Vaccine IXCHIQ® IXCHIQ® sales were €4.4 million in the first half of 2026 including initial shipments of the vaccine’s drug substance to Instituto Butantan, compared with €7.5 million in the first half of 2025. The prior-year period benefited from sales in the U.S. and from 40,000 doses provided to the French island of La Réunion in response to a chikungunya outbreak. In light of the product uptake in travel, the Company is currently evaluating its future commercial strategy for IXCHIQ® including a potential focus on endemic markets. Operating Result and adjusted EBITDACosts of goods and services sold were €59.5 million in the first half of 2026, compared to €47.2 million in the first half of 2025. As a result, gross profit decreased to €6.3 million. The decrease in gross profit was primarily attributable to lower sales and manufacturing volumes across the portfolio, adverse cost impacts related to IXCHIQ® inventory provisions and third-party manufacturing, supply contract termination costs, and higher idle manufacturing costs that were neither capitalized nor allocated to products. As a result, product-level gross margin before unallocated costs decreased to €14.7 million in the first half of 2026 from €54.4 million in the first half of 2025. Gross profit was further reduced by €9.4 million in unallocated manufacturing costs, including idle capacity and other costs not allocated to products, compared to €6.0 million in the first half of 2025. * as % of total revenues * as % of total revenues IXIARO® gross margin was 56.4% in the first half of 2026, compared to 65.5% in the first half of 2025. The decrease mainly reflects lower volumes and adverse changes in manufacturing costs, partly offset by a favorable average selling price and product/country mix effect. The prior year gross margin had benefited from a particularly high manufacturing volume and related cost absorption.DUKORAL® gross margin was 24.7% in the first half of 2026, compared to 52.9% in the first half of 2025 and 33.3% for the full year 2025. Gross profit decreased to €3.6 million in the first half of 2026 from €9.2 million in the first half of 2025, mainly due to lower volumes. In the first half of 2025, production timing and the prior-year manufacturing shutdown resulted in favorable absorption and inventory valuation effects. By contrast, the first half of 2026 was adversely impacted by inventory valuation and revaluation effects, as well as higher failed batch costs. Gross margin for IXCHIQ® was negative, mostly impacted by one-time cancellation fees related to external manufacturing commitments of €9.7 million and a €4.5 million non-cash impairment of excess inventory, both resulting from lower than anticipated sales. The financial impact reflects the company’s decision to shift its commercial focus for chikungunya to endemic territories where the risk of chikungunya virus infection is highest. Third-party product gross profit was €0.2 million in the first half of 2026, compared to €4.5 million in the first half of 2025. The decrease reflects the planned wind-down of third-party distribution activities. Cost of services amounted to €0.8 million in the first half of 2026 compared to €4.6 million in the first half of 2025, which included revenue recognition from the IXCHIQ license agreement with Serum Institute of India, terminated in December 2025. Research and development expenses declined to €30.2 million in the first half of 2026, compared to €32.4 million for the same period in 2025. The decrease was largely attributable to the reprioritization and rescheduling of R&D activities. Marketing and distribution expenses totaled €13.5 million in the first half year of 2026, down significantly from €20.3 million in the first half year of 2025. The decrease primarily reflects lower advertising and promotional expenses related to IXCHIQ® as well as reduced personnel, warehousing and distribution costs. General and administrative expenses decreased to €15.4 million in the first half of 2026, from €19.0 million in the same period of 2025. The reduction was primarily driven by lower personnel costs and savings in advisory and professional services. In the first half of 2026, €3.2 million of expenses were recognized across the affected functions in connection with the workforce reduction and restructuring program initiated in the second quarter of 2026. Other income, net of other expenses, decreased to €2.9 million in the first half of 2026 from €4.6 million in the same period of 2025. The decrease was primarily attributable to lower R&D tax credits, partially offset by higher grant income. Valneva recorded an operating loss of €49.9 million in the first half of 2026 compared with an operating loss of €16.8 million in the same period of 2025. The increase in operating loss was mainly driven by lower product sales and one-time charges related to IXCHIQ® recorded in the first half of 2026, which were not incurred in the prior-year period. Adjusted EBITDA loss (as defined below) was €40.1 million in the first half of 2026, compared with an adjusted EBITDA loss of €6.0 million in the corresponding period of 2025. Operating Loss and Net Result Operating loss was €49.9 million in the first half of 2026 compared to €16.8 million in the first half of 2025. In the first half of 2026, about 50% of the operating loss was generated by IXCHIQ®.Net loss was €63.3 million in the first half of 2026 compared to a net loss of €20.8 million in the first half of 2025. The increase was primarily driven by lower gross profit, reflecting lower product sales and higher COGS, including IXCHIQ®-related manufacturing contract cancellation fees, inventory charges and idle capacity costs. The loss was partly offset by lower R&D, marketing and distribution, and G&A expenses. Finance expense and currency effects resulted in a net finance expense of €13.1 million in the first half year of 2026, compared with a net finance expense of €2.7 million in the first half year of 2025. The increased expenses were mainly attributable to unfavorable movements in the USD/EUR exchange rate, resulting in a foreign currency loss of €3.9 million in the first half of 2026 compared with a foreign currency gain of €7.8 million in the first half year of 2025. Cash Flow and Liquidity Net cash used in operating activities amounted to €13.7 million in the first half of 2026 compared to €10.9 million in the same period of 2025. The increase in the first half of 2026 was primarily driven by increased losses during the period, partially offset by lower net working capital requirements. Cash inflows from investing activities amounted to €0.6 million in the first half of 2026 compared to cash outflows of €1.6 million in the same period of 2025. Cash inflows in the first half of 2026 were largely attributable to proceeds from investments in money market funds. By contrast, cash outflows in the first half year of 2025 were mainly related to the purchase of equipment, partially offset by interest income. Net cash generated by financing activities amounted to €24.5 million in the first half of 2026 compared to a net cash inflow of €9.3 million in the same period in 2025. Cash generated during the first half of 2026 included net proceeds of €34.3 million from a capital raise completed in the second quarter of 2026. By comparison, cash inflows in the same period of 2025 included net proceeds from capital raises of €20.1 million. Both quarters included interest payments, amounting to €8.9 million in the first six months of 2026 and €9.5 million in the same period of the prior year. Cash and cash equivalents were €121.5 million as at June 30, 2026, compared to €109.7 million at December 31, 2025. Non-IFRS Financial Measures Management uses and presents IFRS results as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva’s current performance, performance trends, and financial condition. Adjusted EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provides additional analytical tool. Adjusted EBITDA is defined as earnings / (loss) for the period before income tax, finance (income)/expense, foreign exchange (gain)/loss, amortization, depreciation, and impairment. A reconciliation of Adjusted EBITDA to net loss for the period, which is the most directly comparable IFRS measure, is set forth below: Product sales (excluding third-party sales) at constant exchange rate: References to changes in net sales at constant exchange rate (CER) indicate that currency fluctuation effects have been removed. Net sales for the period in question are recalculated using the exchange rates applied in the prior period, as detailed below: About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in France. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements with respect to: future financial performance and financial guidance including projected product sales, total revenue and total R&D investments; Valneva’s plans for investment in future growth; the timing of orders for commercial products; plans and expectations regarding the development, commercialization and commercial prospects of Valneva’s product candidates and commercial products, including the prospects and timing of actions relating to clinical studies and trials and product approvals, such as study initiations, study advancements, data readouts, submissions, filings, approvals, and label expansions; the expected benefits and availability of Valneva’s commercial products and product candidates; and potential growth opportunities and trends, including the assumptions and expectations regarding total market opportunity targeted by Valneva’s product candidates and commercial products. These forward-looking statements are based on Valneva’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Valneva’s business, strategy, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: Valneva’s success in the commercialization of its commercial products; uncertainties and delays involved in the development and manufacture of vaccines; the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including tariffs and other trade policies, the conflict in Ukraine and the conflict in the Middle East, fluctuations in inflation and uncertain credit and financial markets, on Valneva’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Valneva’s ability to realize the benefits of its collaboration and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; the impact of the global and European credit crisis; the ability to obtain or maintain patent or other proprietary intellectual property protection and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors” in Valneva’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) and the Autorité des marchés financiers (“AMF”) on March 18, 2026, and in other filings made with the SEC and AMF from time to time. Valneva is providing this information as of the date of this press release and expressly disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. 1 Valneva Announces the Successful Completion of an €84 million Reserved Offering - Valneva2 https://s206.q4cdn.com/795948973/files/doc_financials/2026/q2/Q2-2026-Earnings-Charts-FINAL.pdf3 https://s206.q4cdn.com/795948973/files/doc_events/2026/Jun/08/PFE-USQ_Transcript_2026-06-08.pdf4 Valneva Reports First Quarter 2026 Financial Results and Provides Corporate Updates - Valneva 5 For additional information on Adjusted EBITDA, please refer to the “Non-IFRS Financial Measures” section at the end of the PR6 2026_03_23_Lyme-Phase-3-Data-Read-out_PR_EN_FINAL.pdf7 https://s206.q4cdn.com/795948973/files/doc_events/2026/Jun/08/PFE-USQ_Transcript_2026-06-08.pdf8 https://s206.q4cdn.com/795948973/files/doc_financials/2026/q2/Q2-2026-Earnings-Charts-FINAL.pdf9 Study Details | NCT07347002 | Observational Study to Assess the Effectiveness of VLA1553 Vaccine in Preventing Chikungunya During a Pilot Vaccination Strategy in Brazil | ClinicalTrials.gov10 Study Details | NCT07414524 | VLA1553-403 Pregnancy Surveillance Study | ClinicalTrials.gov11 Study Details | NCT07254702 | Prospective Safety Cohort Study After VLA1553 Vaccination in Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil | ClinicalTrials.gov12 CEPI, Chikungunya13 Valneva and LimmaTech Announce First Vaccination in Phase 2 Infant Study of Tetravalent Shigella Vaccine Candidate S4V2 - Valneva14 Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V215 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate - Valneva16 Immunization, Vaccines and Biologicals (who.int)17 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva18 LEK analysis19 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed; ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. Attachment 2026_08_13_VLA_H1_2026_PR_EN_Final

Pfizer’s second quarter results reflected stability in its core business despite ongoing challenges in COVID-related product demand. The company’s performance was shaped by strong execution in its non-COVID portfolio, with management highlighting robust revenue contributions from acquired brands and recent launches. CEO Albert Bourla attributed operational progress to “continued strategic progress” and emphasized the value generated by recent acquisitions such as Seagen and Biohaven. Management also pointed to the success of brands like Eliquis and Padcev, noting that commercial teams “performed with excellence and precision” across major therapeutic areas. Is now the time to buy PFE? Find out in our full research report (it’s free). Revenue: $15.03 billion vs analyst estimates of $14.4 billion (2.6% year-on-year growth, 4.4% beat) Adjusted EPS: $0.77 vs analyst estimates of $0.68 (12.9% beat) The company slightly lifted its revenue guidance for the full year to $61.5 billion at the midpoint from $61 billion Management reiterated its full-year Adjusted EPS guidance of $2.90 at the midpoint Operating Margin: 27.9%, in line with the same quarter last year Organic Revenue rose 1% year on year Market Capitalization: $154.2 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Evan Seigerman (BMO Capital Markets) asked about the benchmarks for success in the upcoming MEVPRO-1 prostate cancer trial; Chief Scientific Officer Chris Boshoff clarified that a clinically meaningful benefit of 30% over standard care would validate the mechanism. Christopher Schott (JPMorgan) questioned the drivers behind the non-COVID revenue guidance increase and Padcev’s growth outlook; Interim CFO Cecile Guegan pointed to broad strength across key brands, with Padcev expected to moderate but remain a major growth engine. Umer Raffat (Evercore ISI) inquired about the commercial potential of mevrometostat; Commercial Chief Aamir Malik emphasized its global opportunity and scale across the disease continuum if approved. Akash Tewari (Jefferies) probed efficacy and future plans for atirmociclib and the impact of proposed changes to 340B hospital payments; Boshoff highlighted atirmociclib’s tolerability and planned adjuvant trials, while CEO Bourla noted regulatory uncertainty on reimbursement changes. Terence Flynn (Morgan Stanley) pressed on the sustainability of the dividend amid business development constraints; CEO Bourla asserted that even under stressed scenarios, the dividend would be maintained and could eventually grow post patent expirations. In the next several quarters, the StockStory team will be watching (1) clinical readouts for late-stage oncology and obesity programs, (2) the pace of cost savings realization and manufacturing optimization, and (3) the expansion of commercial uptake for recently acquired brands and new product launches. Progress on artificial intelligence integration and further regulatory milestones will also be important indicators of execution. Pfizer currently trades at $26.97, up from $25.03 just before the earnings. At this price, is it a buy or sell? See for yourself in our full research report (it’s free for active Edge members). ALSO WORTH WATCHING: Top 5 Momentum Stocks. The best time to own a great stock is when the market is finally noticing it. These aren’t just high-quality businesses. Something is happening with them right now. Elite fundamentals meet near-term momentum — both boxes checked at the same time. Find out which stocks our AI platform is flagging this week. See this week’s Strong Momentum stocks — FREE. Get Our Strong Momentum Stocks for Free HERE. Stocks that have made our list include now familiar names such as Nvidia (+1,460% between June 2020 and June 2025) as well as under-the-radar businesses like the once-micro-cap company Tecnoglass (+1,552% between June 2020 and June 2025). Find your next big winner with StockStory today.

This article first appeared on GuruFocus. Cash and Cash Equivalents: $50.8 million as of June 30, 2026, excluding net proceeds from the July 2026 royalty financing. Revenue: No revenue for Q2 2026, compared to $14.2 million in Q2 2025, primarily due to prior collaboration revenue from Pfizer and GSK being fully realized. R&D Expenses: $3.4 million in Q2 2026, down from $10.7 million in Q2 2025, due to reduced clinical activity following the early completion of the Utebzi Phase 3 trial. G&A Expenses: $6.5 million in Q2 2026, up from $5.9 million in Q2 2025, driven by higher business development, legal, and consulting costs. Net Loss: $9.6 million for Q2 2026, compared to a net loss of $1.7 million in Q2 2025. Diluted Net Loss Per Share: $0.16 for Q2 2026, versus $0.03 in Q2 2025. Cash Runway Guidance: Updated to fund operations into the second half of 2029, including the $35 million nonrefundable upfront payment to Innovent. Warning! GuruFocus has detected 4 Warning Signs with SPRO. Is SPRO fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. FDA approval of Utebzi, the first oral carbapenem antibiotic, provides a significant commercial milestone and potential revenue stream through GSK partnership. In-licensing of SP001, a third-generation anti-CD40L antibody, diversifies pipeline into high-unmet-need immunology, with potential across multiple autoimmune indications. Closed $105 million non-dilutive, non-recourse royalty financing, strengthening balance sheet and extending cash runway into the second half of 2029. Appointment of Dr. Debra Zack as CMO brings deep immunology expertise, enhancing clinical development capabilities for SP001. SP001's mechanism targeting CD40L offers a differentiated approach by modulating upstream immune activation, potentially addressing multiple disease pathways in IgG4-RD. No revenue recorded in Q2 2026, down from $14.2 million in Q2 2025, due to completion of prior collaboration agreements. Net loss widened to $9.6 million in Q2 2026 from $1.7 million in Q2 2025, reflecting increased expenses and lack of revenue. SP001 is still in early clinical stages, with Phase 2 trial not expected to begin until Q2 2027, indicating a long path to potential commercialization. The royalty financing carries a 10% annual interest rate and nine-year maturity, with payments derived solely from Utebzi milestones/royalties, which may be uncertain. Dependence on GSK's successful launch and sales of Utebzi for future royalty income, which is subject to market and regulatory risks. Q: How are you thinking about assessing the magnitude and significance of clinical benefit in the planned Phase 2 trial for SP001 in IgG4-RD, and how does this align with the product's potential market positioning? Additionally, what structural features of the molecule suggest it could be best-in-class in the CD40 ligand category?A: Dr. Debra Zack (CMO): For the Phase 2 trial, we will focus on symptom control, disease control over time, and reduction in steroid and DMARD use, rather than flare suppression, which is typically reserved for Phase 3 trials. The structural features of SP001, being a fully humanized, Fc-silent IgG1 monoclonal antibody, offer a very specific interaction with the target and favorable pharmacokinetics compared to other molecules in the CD40 ligand space, which are often fusion proteins. This specificity makes it a very attractive candidate. Q: How might SP001 be deployed in the current treatment landscape for IgG4-RD, and how does the commercial experience with Uplizna inform your view of the market opportunity?A: Esther Rajavelu (CEO): We cannot comment on Uplizna's uptake, but the IgG4-RD market is early in its life cycle. Diagnosis rates are expected to improve, especially with the new diagnostic code established in October 2023. As patient communities and prescriber awareness grow, we anticipate a higher uptake and increasing diagnosis rates, similar to other rare diseases. Dr. Zack added that SP001 could be used to maintain disease control, smoothing out the current cycle of flares and remissions, and could be used after other agents like B-cell depleters to provide sustained control. Q: Can you elaborate on the key highlights and strategic milestones for Spero in the second quarter of 2026?A: Esther Rajavelu (CEO): We achieved four major milestones: the FDA approved Utebzi, the first oral carbapenem for complicated UTIs; we in-licensed SP001 and repositioned the pipeline toward immune-mediated diseases; we closed a $105 million non-dilutive, non-recourse royalty financing; and we hired Dr. Debra Zack as our Chief Medical Officer. These events have strengthened our balance sheet and positioned us to execute on our new immunology-focused strategy. Q: What is the significance of the FDA approval of Utebzi, and what are the next steps for commercialization?A: Esther Rajavelu (CEO): The FDA approved Utebzi on June 17, 2026, for complicated urinary tract infections, including pyelonephritis. It is the first and only oral carbapenem approved in the US. GSK holds exclusive commercialization rights worldwide (excluding certain Asian territories) and expects Utebzi to be available to US patients in the second half of 2026. This approval provides Spero with the opportunity to pursue growth in immunological diseases. Q: Can you provide details on the $105 million royalty financing and its impact on the company's cash runway?A: Esther Rajavelu (CEO): We closed a $105 million non-dilutive, non-recourse royalty financing with Healthcare Royalty. The notes carry a 10% annual interest rate and a nine-year maturity, with payments derived solely from GSK's milestone and royalty payments on Utebzi. After the notes are repaid, Spero retains 35% of additional proceeds. This transaction strengthens our balance sheet and extends our cash runway into the second half of 2029, providing capital to fund SP001's clinical development. Q: What is the rationale for targeting CD40 ligand with SP001, and why is this mechanism attractive for immune-mediated diseases?A: Dr. Debra Zack (CMO): CD40 ligand is an upstream immune activation signal at the interface of adaptive and innate immunity. Blocking it interrupts a critical activation signal, modulating the conversation between T cells, B cells, and antigen-presenting cells before they become pathogenic. This mechanism has the potential to modulate multiple components of the disease process simultaneously, making it attractive across multiple autoimmune indications, not just IgG4-RD. Q: What is the current treatment landscape for IgG4-RD, and where does SP001 fit in?A: Dr. Debra Zack (CMO): IgG4-RD is a serious, chronic fibroinflammatory disease affecting nearly every organ system. Currently, patients are monitored until flares, then treated with off-label options like steroids or DMARDs. If uncontrolled, they may progress to B-cell depleters like rituximab or Uplizna. This creates a cycle of remission and relapse. SP001, by targeting CD40 ligand upstream, could disrupt the pathologic interaction between T cells and B cells, potentially stopping the fibroinflammatory process and providing more consistent disease control. Q: What are the financial results for the second quarter of 2026?A: Esther Rajavelu (CEO): As of June 30, 2026, the company had cash and cash equivalents of $50.8 million, which does not reflect the July royalty financing proceeds. There was no revenue for Q2 2026, compared to $14.2 million in Q2 2025, due to prior collaboration revenue being fully realized. R&D expenses decreased to $3.4 million from $10.7 million, primarily due to reduced clinical activity. G&A expenses increased to $6.5 million from $5.9 million. The net loss was $9.6 million, or $0.16 per share, compared to a net loss of $1.7 million, or $0.03 per share, in the prior year period. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Transitioned the corporate focus to immune-mediated diseases following the FDA approval of Utebzi, the first oral carbapenem for complicated urinary tract infections. In-licensed SP001, a third-generation fully humanized Fc silent IgG1 monoclonal antibody targeting CD40 ligand, to serve as the new lead clinical asset. Secured $105 million in non-dilutive, non-recourse royalty financing from Healthcare Royalty to fund the immunology pipeline without exposing core assets to Utebzi commercial risk. Appointed Dr. Debra Zack as Chief Medical Officer to leverage her 25 years of experience in rheumatology and immunology for the development of SP001. Attributed the year-over-year revenue decline to the full realization of collaboration revenue from Pfizer and GSK and the completion of government award funding. Reduced R&D expenses significantly due to the early completion of the Utebzi Phase III trial and associated lower personnel-related costs. Positioned the company with a cash runway extending into the second half of 2029, covering the $35 million upfront payment for SP001 and future clinical operations. Plans to initiate a Phase II trial for SP001 in IgG4-related disease (IgG4-RD) in the second quarter of 2027, focusing on establishing proof of concept. Anticipates increased diagnosis rates for IgG4-RD driven by the implementation of a specific diagnostic code in October 2023 and evolving treatment guidelines. Expects GSK to make Utebzi available to U.S. patients in the second half of 2026, which will trigger the milestone and royalty streams used to service the new debt. Intends to evaluate additional development opportunities for SP001 beyond IgG4-RD to expand the asset's value proposition across multiple autoimmune indications. Assumes a clinical strategy for IgG4-RD that aims to disrupt the pathologic interaction between T cells and B cells to stop fibroinflammatory progression. The $105 million royalty financing is structured as senior secured notes with a 10% interest rate, payable solely from Utebzi-related proceeds from GSK. Spero retains 35% of Utebzi milestone and royalty proceeds after the notes are fully repaid, preserving long-term upside from the antibiotic asset. Management highlighted that the financing is non-recourse, meaning Spero's other assets and cash are protected regardless of Utebzi's commercial performance. Identified the current IgG4-RD landscape as having high unmet need, as existing off-label treatments often lead to a cycle of remission and relapse. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management stated that SP001's specific PK profile and monoclonal antibody structure offer potentially better control and specificity compared to fusion protein competitors. The Phase II trial will prioritize symptom control and reduction in steroid/DMARD use, while flare suppression will be the primary focus of a subsequent Phase III trial. The mechanism targets the 'crosstalk' between T cells and B cells, aiming to modulate the immune response before it becomes pathogenic. Management envisions SP001 as a way to 'smooth out' treatment regimens by providing durable long-term control, unlike current B-cell depleters that allow disease return upon repopulation. The drug could potentially be used as an adjunct or follow-up to existing therapies to prevent the relentless return of fibroinflammatory damage. The company expects the market to expand as rheumatologists become more aware of the disease and patient communities coalesce around new approved therapies.