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Investor releaseQuarter not tagged2026-09-02Argenx Has Delivered 18 Consecutive Quarters of Sales Growth -- but Is the Biotech Stock Still Underrated?
Motley Fool
Argenx Has Delivered 18 Consecutive Quarters of Sales Growth -- but Is the Biotech Stock Still Underrated?
To say that Argenx (NASDAQ: ARGX) is growing is an understatement. The drugmaker has delivered an impressive 18 consecutive quarters of revenue growth. Its sales soared 60% year over year in the second quarter of 2026 and 17% sequentially. Investors have recognized Argenx's success. The biotech stock is handily beating the overall market so far this year and has more than doubled over the last three years. But is Argenx still underrated? Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue » There's no secret about where Argenx's revenue growth is coming from. The company's Vyvgart and Vyvgart Hytrulo therapies continue to gain momentum in treating severe autoimmune diseases. Vyvgart is approved in the U.S. for generalized myasthenia gravis (gMG) and in Japan for the treatment of immune thrombocytopenia (ITP). Vyvgart Hytrulo combines Vyvgart with recombinant human hyaluronidase PH20, Halozyme's (NASDAQ: HALO) drug delivery technology. It's also approved for gMG and for chronic inflammatory demyelinating polyneuropathy (CIDP). But Argenx's top line is only part of the story. The company reported earnings of $472 million in Q2, nearly double its profit from the prior year period. Its operating margins are expanding. Argenx CFO Karl Gubitz recently told Reuters that rivals in the gMG market were "all behind Vyvgart." Gubitz also noted that only about 20% of gMG patients are currently receiving novel biologics, leaving Argenx with significant room for future growth. Meanwhile, the CIDP market penetration for the Vyvgart franchise is only in its early stages. Argenx recently reported a big clinical win. On Aug, 17, 2026, the company announced positive results from a late-stage study evaluating Vyvgart Hytrulo for the treatment of autoimmune myositis, an autoimmune disease that affects around 100,000 people in the U.S. Management believes this indication represents a multibillion-dollar opportunity. More good news could be right around the corner. Argenx expects to report results from its Phase 3 study of empasiprubart in the treatment of multifocal motor neuropathy (MMN) in the fourth quarter of 2026. If those results look good, the company will be…Read full documentShow less
To say that Argenx (NASDAQ: ARGX) is growing is an understatement. The drugmaker has delivered an impressive 18 consecutive quarters of revenue growth. Its sales soared 60% year over year in the second quarter of 2026 and 17% sequentially. Investors have recognized Argenx's success. The biotech stock is handily beating the overall market so far this year and has more than doubled over the last three years. But is Argenx still underrated? Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue » There's no secret about where Argenx's revenue growth is coming from. The company's Vyvgart and Vyvgart Hytrulo therapies continue to gain momentum in treating severe autoimmune diseases. Vyvgart is approved in the U.S. for generalized myasthenia gravis (gMG) and in Japan for the treatment of immune thrombocytopenia (ITP). Vyvgart Hytrulo combines Vyvgart with recombinant human hyaluronidase PH20, Halozyme's (NASDAQ: HALO) drug delivery technology. It's also approved for gMG and for chronic inflammatory demyelinating polyneuropathy (CIDP). But Argenx's top line is only part of the story. The company reported earnings of $472 million in Q2, nearly double its profit from the prior year period. Its operating margins are expanding. Argenx CFO Karl Gubitz recently told Reuters that rivals in the gMG market were "all behind Vyvgart." Gubitz also noted that only about 20% of gMG patients are currently receiving novel biologics, leaving Argenx with significant room for future growth. Meanwhile, the CIDP market penetration for the Vyvgart franchise is only in its early stages. Argenx recently reported a big clinical win. On Aug, 17, 2026, the company announced positive results from a late-stage study evaluating Vyvgart Hytrulo for the treatment of autoimmune myositis, an autoimmune disease that affects around 100,000 people in the U.S. Management believes this indication represents a multibillion-dollar opportunity. More good news could be right around the corner. Argenx expects to report results from its Phase 3 study of empasiprubart in the treatment of multifocal motor neuropathy (MMN) in the fourth quarter of 2026. If those results look good, the company will be well-positioned to launch its second "pipeline-in-a-product." Argenx is scheduled to make four other important announcements next year. It plans to report top-line results from a pivotal study of Vyvgart in treating ITP in the first half of 2027 and from another pivotal study in treating Sjogren's disease in the second half. The company also expects to report results from two studies evaluating empasiprubart in treating CIDP in the second half of 2027. The recent acquisition of Forte Biosciences adds another promising candidate to Argenx's pipeline, the anti-CD122 antibody FB102. Argenx expects to announce results from a Phase 2 study of the experimental therapy for celiac disease and from a Phase 1b study for alopecia areata before the end of 2026. Is Argenx underrated? The verdict is "yes," according to Wall Street. Of the 23 analysts surveyed by S&P Global (NYSE: SPGI) in August, 20 rated the stock as a "buy" or "strong buy." The other three recommended holding Argenx. The 12-month price target for the stock reflects a potential upside of roughly 14%. Sure, Argenx looks expensive, with shares trading at 37.5 times forward earnings. However, growth stocks with significant opportunities usually command premium valuations. Given Vyvgart's expansion opportunities and its promising pipeline, I agree with analysts. Despite its tremendous success, Argenx remains an underrated biotech stock. Before you buy stock in Argenx Se, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Argenx Se wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $437,097!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,355,077!* Now, it’s worth noting Stock Advisor’s total average return is 978% — a market-crushing outperformance compared to 213% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of September 2, 2026. Keith Speights has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Argenx Se and S&P Global. The Motley Fool has a disclosure policy. Argenx Has Delivered 18 Consecutive Quarters of Sales Growth -- but Is the Biotech Stock Still Underrated? was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-08-17Zai Lab and argenx Announce Positive Topline Results from Phase 3 ALKIVIA Trial of Efgartigimod in Autoimmune Myositis
Business Wire
Zai Lab and argenx Announce Positive Topline Results from Phase 3 ALKIVIA Trial of Efgartigimod in Autoimmune Myositis
Study met primary endpoint of mean Total Improvement Score (TIS) at Week 52 in the combined study population of IMNM and DM patients (p=0.0011) Patient improvements observed early and sustained throughout study; consistent treatment effect across IMNM and DM First Phase 3 study to show statistically significant and clinically meaningful improvements in disease activity in IMNM, a subtype with no approved therapy SHANGHAI & CAMBRIDGE, Mass. & AMSTERDAM, August 17, 2026--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & NASDAQ: ARGX), today announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. Study met its primary endpoint (p=0.0011) In the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, patients treated with efgartigimod demonstrated statistically significant and clinically meaningful 15.4 point greater improvement in mean Total Improvement Score (TIS) at Week 52 versus placebo (47.95 vs 32.56). Rapid and sustained treatment benefit In the combined population, patients treated with efgartigimod consistently showed improvements over placebo starting at Week 4 that were statistically significant and sustained through the full year of treatment, even with steroid tapering. Magnitude of clinical improvement consistent across both IMNM and DM In prespecified subtype analyses, the primary endpoint of Mean TIS at 52 weeks was also met in IMNM patients treated with efgartigimod (p=0.0048), with a 14.8 point greater improvement over placebo (45.05 vs 30.24). In DM, a similar clinically meaningful improvement of 14.5 points (p=0.1093) was observed (51.51 vs 36.96), though statistical significance was not reached in this smaller cohort. Clinical impact observed in both muscle and skin measures In both IMNM and DM, all six core set measures of TIS contributed to the treatment effect, each favoring efgartigimod over placebo, spanning muscle strength, everyday physical function, and disease activity beyond the muscle. In DM, improvement in skin disease activity was also observed. Efgartigimod was well-tolerated by patients in the ALKIVIA study. The observed safety profile was consistent with prior studies and the known safety profile of efgartigimod. "The Phase 3 ALKIVIA results de…Read full documentShow less
Study met primary endpoint of mean Total Improvement Score (TIS) at Week 52 in the combined study population of IMNM and DM patients (p=0.0011) Patient improvements observed early and sustained throughout study; consistent treatment effect across IMNM and DM First Phase 3 study to show statistically significant and clinically meaningful improvements in disease activity in IMNM, a subtype with no approved therapy SHANGHAI & CAMBRIDGE, Mass. & AMSTERDAM, August 17, 2026--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & NASDAQ: ARGX), today announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. Study met its primary endpoint (p=0.0011) In the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, patients treated with efgartigimod demonstrated statistically significant and clinically meaningful 15.4 point greater improvement in mean Total Improvement Score (TIS) at Week 52 versus placebo (47.95 vs 32.56). Rapid and sustained treatment benefit In the combined population, patients treated with efgartigimod consistently showed improvements over placebo starting at Week 4 that were statistically significant and sustained through the full year of treatment, even with steroid tapering. Magnitude of clinical improvement consistent across both IMNM and DM In prespecified subtype analyses, the primary endpoint of Mean TIS at 52 weeks was also met in IMNM patients treated with efgartigimod (p=0.0048), with a 14.8 point greater improvement over placebo (45.05 vs 30.24). In DM, a similar clinically meaningful improvement of 14.5 points (p=0.1093) was observed (51.51 vs 36.96), though statistical significance was not reached in this smaller cohort. Clinical impact observed in both muscle and skin measures In both IMNM and DM, all six core set measures of TIS contributed to the treatment effect, each favoring efgartigimod over placebo, spanning muscle strength, everyday physical function, and disease activity beyond the muscle. In DM, improvement in skin disease activity was also observed. Efgartigimod was well-tolerated by patients in the ALKIVIA study. The observed safety profile was consistent with prior studies and the known safety profile of efgartigimod. "The Phase 3 ALKIVIA results demonstrate a clinically meaningful and statistically significant treatment benefit in the overall study population, including a significant improvement in patients with IMNM, a subtype with no approved therapies," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "For patients in China living with autoimmune myositis, these results offer hope for a new targeted treatment option that could meaningfully improve muscle strength, physical function and other manifestations of this debilitating disease. Zai Lab is proud to have participated in this global trial and looks forward to working with argenx to bring this therapy to patients in China as quickly as possible." "For decades, people living with autoimmune myositis have relied on corticosteroids and broad immunosuppression, and those with IMNM have had no approved option at all. These are the first Phase 3 results to show that precision targeting of FcRn with efgartigimod can deliver meaningful benefit in this disease," said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "The patient response to efgartigimod was durable and multidimensional: separation from placebo emerged early and held through a full year of treatment, with a treatment effect of comparable magnitude in IMNM and DM. This confirms that pathogenic IgG autoantibodies are key drivers of autoimmune myositis. We are grateful to the patients, caregivers, and investigators who made this pioneering study possible." "For people living with myositis, the goal is straightforward: regain strength and function, and get off long-term steroids. Until now we have had limited targeted therapies to offer patients," said Rohit Aggarwal, M.D., M.S., Professor of Medicine and Co-Director of the Myositis Center at the University of Pittsburgh, and an ALKIVIA investigator. "IMNM is the most refractory form of this disease and many of these patients carry irreversible muscle damage, which makes meaningful improvement genuinely difficult to achieve. That is what makes these results so compelling and groundbreaking. In DM, the magnitude of improvement was comparable – and for a community where treatment options remain limited and the burden of chronic steroids is just as heavy, that matters. Together these results tell us that reducing pathogenic autoantibodies is clinically meaningful and a major step forward for patients who are in need of a targeted treatment." Detailed results from the ALKIVIA study will be presented at an upcoming medical meeting. Efgartigimod continues to be evaluated as a potential treatment in other autoimmune rheumatologic diseases, including Sjögren’s disease and systemic sclerosis. About the ALKIVIA Study The ALKIVIA study was a global, randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of autoimmune myositis across IMNM, DM and PM. The ALKIVIA study enrolled 264 patients who had active disease and were on background treatment. Participants were randomized (1:1) to receive weekly injections of efgartigimod PH20 SC or matched placebo PH20 SC. The study was conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 89 patients completed the study, followed by Phase 3. The Phase 3 study enrolled 175 patients and included a protocol-mandated corticosteroid taper throughout the study. The primary endpoint of Phase 3 was the mean Total Improvement Score (TIS) at the end of the treatment period of 52 weeks of all treated patients compared to placebo. Prespecified analyses evaluated the combined IMNM and DM population and each subtype separately. argenx has an exclusive license agreement with Zai Lab for the development and commercialization of VYVGART and VYVGART Hytrulo in Greater China. Through this agreement, Zai Lab recruited Chinese patients into the ALKIVIA trial. About Autoimmune Myositis Autoimmune myositis is a heterogenous disease spectrum with autoimmune-mediated pathophysiology, characterized by chronic inflammation and progressive muscle weakness, and in some subtypes by skin involvement and other extramuscular manifestations. Proximal muscle weakness is a hallmark clinical feature across subtypes. Approximately 100,000 people in the United States live with autoimmune myositis, including approximately 20,000 with IMNM and approximately 40,000 with DM. Up to 80 percent of patients report long-term disability despite treatment. There are currently no targeted treatments available, and care relies primarily on corticosteroids and broad immunosuppressants, which are associated with significant cumulative toxicity, including metabolic, cardiovascular, musculoskeletal and infectious complications. Advances in the understanding of autoimmune myositis biology have highlighted the central role of antibody-mediated immunity, with pathogenic IgG autoantibodies contributing to muscle fiber damage and extramuscular manifestations across subtypes. FcRn maintains circulating IgG levels by recycling IgG antibodies, including pathogenic autoantibodies. Efgartigimod is designed to selectively block FcRn, reducing pathogenic IgG autoantibodies while preserving other aspects of immune function. About VYVGART VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo® is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. About argenx argenx is a global immunology innovation company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube. Zai Lab Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for development and commercialization of efgartigimod in Greater China, the safety and efficacy of efgartigimod, and the potential treatment of patients with autoimmune myositis and other autoimmune disorders in Greater China. These forward-looking statements may contain words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov. This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). View source version on businesswire.com: https://www.businesswire.com/news/home/20260817193010/en/ Contacts For more information, please contact:Zai Lab Investor Relations: Christine Chiou / Cyan Liu+1 (917) 886-6929 / +86 195 3130 [email protected] / [email protected] Zai Lab Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 [email protected] / [email protected] argenx Media Contact: Colin [email protected] argenx Investor Contact: Alexandra [email protected]
Investor releaseQuarter not tagged2026-08-07Halozyme's Q2 Earnings Beat Estimates, 2026 Outlook Raised, Stock Up
Zacks
Halozyme's Q2 Earnings Beat Estimates, 2026 Outlook Raised, Stock Up
Halozyme Therapeutics HALO reported second-quarter 2026 adjusted earnings of $2.28 per share, which comprehensively beat the Zacks Consensus Estimate of $1.82. Earnings rose 48.1% year over year. Total revenues in the second quarter increased 48% year over year to $481 million. Revenues also surpassed the Zacks Consensus Estimate of $410 million. The top-line growth was primarily driven by increased product sales and higher royalty payments. HALO received royalty payments from J&J JNJ for subcutaneous Darzalex (daratumumab) as well as argenx ARGX for Vyvgart Hytrulo. Several companies use Halozyme’s Enhanze technology to develop a subcutaneous formulation of their currently marketed drugs. The company has several marketed partnered drugs based on this technology, including the subcutaneous (SC) formulation of J&J’s Darzalex, argenx’s Vyvgart Hytrulo and Roche’s Phesgo. Shares of Halozyme were up in pre-market trading today owing to the better-than-expected results as well as the increased 2026 outlook. The stock has rallied 27.5% year to date compared with the industry’s increase of 4.4%. Image Source: Zacks Investment Research Halozyme’s top line comprises product sales, royalties and revenues under collaborative agreements. Royalty revenues totaled $307.7 million in the second quarter, up 50% from the year-ago quarter’s level. This was mainly due to the robust demand for JNJ's subcutaneous Darzalex and ARGX's Vyvgart Hytrulo, on which it earns royalties. Royalty revenues beat our model estimate of $277.2 million. Product sales were $129.6 million in the second quarter, up 59% from the year-ago quarter’s level. HALO has two commercial proprietary products, Hylenex and Xyosted, with the latter acquired from Antares Pharma in 2022. Product sales beat our model estimate of $99.3 million. Revenues under collaborative agreements were $43.6 million in the reported quarter, up almost 13.2% year over year. Adjusted EBITDA was $328.8 million in the reported quarter, compared with $225.5 million in the year-ago quarter. Halozyme had cash, cash equivalents and marketable securities of $231.9 million as of June 30, 2026, compared with $320.9 million as of March 31, 2026. Halozyme raised its total revenue guidance for 2026. The company now expects total revenues in the range of $1.84 billion to $1.91 billion for 2026, compared with the previous expectation of $1.71 bill…Read full documentShow less
Halozyme Therapeutics HALO reported second-quarter 2026 adjusted earnings of $2.28 per share, which comprehensively beat the Zacks Consensus Estimate of $1.82. Earnings rose 48.1% year over year. Total revenues in the second quarter increased 48% year over year to $481 million. Revenues also surpassed the Zacks Consensus Estimate of $410 million. The top-line growth was primarily driven by increased product sales and higher royalty payments. HALO received royalty payments from J&J JNJ for subcutaneous Darzalex (daratumumab) as well as argenx ARGX for Vyvgart Hytrulo. Several companies use Halozyme’s Enhanze technology to develop a subcutaneous formulation of their currently marketed drugs. The company has several marketed partnered drugs based on this technology, including the subcutaneous (SC) formulation of J&J’s Darzalex, argenx’s Vyvgart Hytrulo and Roche’s Phesgo. Shares of Halozyme were up in pre-market trading today owing to the better-than-expected results as well as the increased 2026 outlook. The stock has rallied 27.5% year to date compared with the industry’s increase of 4.4%. Image Source: Zacks Investment Research Halozyme’s top line comprises product sales, royalties and revenues under collaborative agreements. Royalty revenues totaled $307.7 million in the second quarter, up 50% from the year-ago quarter’s level. This was mainly due to the robust demand for JNJ's subcutaneous Darzalex and ARGX's Vyvgart Hytrulo, on which it earns royalties. Royalty revenues beat our model estimate of $277.2 million. Product sales were $129.6 million in the second quarter, up 59% from the year-ago quarter’s level. HALO has two commercial proprietary products, Hylenex and Xyosted, with the latter acquired from Antares Pharma in 2022. Product sales beat our model estimate of $99.3 million. Revenues under collaborative agreements were $43.6 million in the reported quarter, up almost 13.2% year over year. Adjusted EBITDA was $328.8 million in the reported quarter, compared with $225.5 million in the year-ago quarter. Halozyme had cash, cash equivalents and marketable securities of $231.9 million as of June 30, 2026, compared with $320.9 million as of March 31, 2026. Halozyme raised its total revenue guidance for 2026. The company now expects total revenues in the range of $1.84 billion to $1.91 billion for 2026, compared with the previous expectation of $1.71 billion to $1.81 billion. Total revenues are expected to grow due to increased royalty revenues and higher product sales from API. Royalty revenues are now anticipated in the range of $1.22-$1.25 billion versus the earlier projection of $1.13-$1.17 billion. Adjusted EBITDA is expected in the range of $1.23-$1.28 billion, compared with the earlier projection of $1.13-$1.21 billion. Adjusted earnings are now expected in the range of $8.65-$9.00 per share in 2026, up from $7.75-$8.25 per share guided earlier. Halozyme’s adjusted earnings per share guidance included the impact of approximately $60 million related to the recent Hypercon and Surf Bio investment. The adjusted earnings per share guidance does not consider the impact of potential future share repurchases. Halozyme Therapeutics, Inc. price-consensus-eps-surprise-chart | Halozyme Therapeutics, Inc. Quote Halozyme currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Liquidia Corporation LQDA, currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report argenex SE (ARGX) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-07OmniAb Inc (OABI) (Q2 2026) Earnings Call Highlights: Revenue Surges 243% as Two Programs Leap ...
GuruFocus.com
OmniAb Inc (OABI) (Q2 2026) Earnings Call Highlights: Revenue Surges 243% as Two Programs Leap ...
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. OmniAb Inc (NASDAQ:OABI) reported a strong second quarter with total revenue of $13.4 million, a significant increase from $3.9 million in the same period last year, driven by higher milestone revenue. The company's partner portfolio has advanced significantly, with two programs (rimantomib and persentabartosentican) jumping from Phase 1 directly into Phase 3 during Q2, highlighting the potential of its technology. OmniAb Inc (NASDAQ:OABI) is the only company in the world with a transgenic chicken platform that creates fully human antibody sequences, providing a unique competitive advantage for targeting conserved or difficult-to-drug targets. The company is seeing increasing partner interest and signed new agreements with Argenx and Rosa Therapeutics, indicating strong demand for its OmniChicken and OmniDab platforms. OmniAb Inc (NASDAQ:OABI) improved its net loss to $5.9 million in Q2 2026, compared to a net loss of $15.9 million in the year-ago period, and raised its full-year 2026 revenue guidance to $32 million-$36 million. The company's cash position grew to $52 million in Q2, and it expects to end 2026 with $37 million-$41 million in cash, reflecting improved financial management and operational efficiencies. OmniAb Inc (NASDAQ:OABI) is seeing strong adoption of its Omni Ultra technology, which opens new markets for ultra-long CDRH3 antibodies and peptides, driving inbound interest and potential new applications. The company's exploration platform is gaining traction with the sale of two instruments in Q2, and management believes it can become a meaningful complement to the antibody business with durable revenue streams. OmniAb Inc (NASDAQ:OABI) is well-positioned to benefit from AI and machine learning trends, leveraging its OmniDeep suite and exploration platform to generate proprietary data for novel target discovery. OmniAb Inc (NASDAQ:OABI)'s revenue is heavily dependent on milestone payments, which can vary significantly from quarter to quarter, making financial results lumpy and less predictable. The company still faces a significant gap between its operating expenses and revenue, with expected 2026 GAAP operating expenses of $84 million-$88 million versus revenue of $32 mil…Read full documentShow less
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. OmniAb Inc (NASDAQ:OABI) reported a strong second quarter with total revenue of $13.4 million, a significant increase from $3.9 million in the same period last year, driven by higher milestone revenue. The company's partner portfolio has advanced significantly, with two programs (rimantomib and persentabartosentican) jumping from Phase 1 directly into Phase 3 during Q2, highlighting the potential of its technology. OmniAb Inc (NASDAQ:OABI) is the only company in the world with a transgenic chicken platform that creates fully human antibody sequences, providing a unique competitive advantage for targeting conserved or difficult-to-drug targets. The company is seeing increasing partner interest and signed new agreements with Argenx and Rosa Therapeutics, indicating strong demand for its OmniChicken and OmniDab platforms. OmniAb Inc (NASDAQ:OABI) improved its net loss to $5.9 million in Q2 2026, compared to a net loss of $15.9 million in the year-ago period, and raised its full-year 2026 revenue guidance to $32 million-$36 million. The company's cash position grew to $52 million in Q2, and it expects to end 2026 with $37 million-$41 million in cash, reflecting improved financial management and operational efficiencies. OmniAb Inc (NASDAQ:OABI) is seeing strong adoption of its Omni Ultra technology, which opens new markets for ultra-long CDRH3 antibodies and peptides, driving inbound interest and potential new applications. The company's exploration platform is gaining traction with the sale of two instruments in Q2, and management believes it can become a meaningful complement to the antibody business with durable revenue streams. OmniAb Inc (NASDAQ:OABI) is well-positioned to benefit from AI and machine learning trends, leveraging its OmniDeep suite and exploration platform to generate proprietary data for novel target discovery. OmniAb Inc (NASDAQ:OABI)'s revenue is heavily dependent on milestone payments, which can vary significantly from quarter to quarter, making financial results lumpy and less predictable. The company still faces a significant gap between its operating expenses and revenue, with expected 2026 GAAP operating expenses of $84 million-$88 million versus revenue of $32 million-$36 million. OmniAb Inc (NASDAQ:OABI) continues to operate at a net loss, with a year-to-date net loss of $13.6 million, and relies on future milestones and royalties to close the funding gap. The exploration platform's revenue contribution is still early-stage, with only four instruments in the field, and management notes it is too early to discuss consumables or consistent sales cadence. The company's cash runway, while improved, is still limited, and it may need to seek external funding if milestone payments or partner progress do not materialize as expected. OmniAb Inc (NASDAQ:OABI) faces potential delays in partner programs, as seen with the need for additional preclinical work for certain antibody programs, which could slow the progression of its pipeline. The company's revenue guidance for the back half of 2026 implies lower quarterly revenue, reflecting the front-end loading of milestone achievements and potential conservatism in guidance. OmniAb Inc (NASDAQ:OABI) is still in a period where royalties are not yet a significant revenue stream, and the transition to royalty-based income depends on partner programs advancing to potential approvals. Warning! GuruFocus has detected 3 Warning Signs with OABI. Is OABI fairly valued? Test your thesis with our free DCF calculator. Q: Given the strong quarter and the raised guidance, how should we think about closing the gap between current spend and expected revenues? Will you continue to self-fund, or will you need to draw funds from outside?A: Matt Foehr (CEO) and Kurt (CFO) expressed strong confidence in the company's position, highlighting $340 million in potential milestones tied to late-stage assets and a robust flow of new deal interest. Kurt detailed that the company started the year with $54 million in cash and expects to burn only about $15 million in 2026, providing a long runway. He emphasized that as the clinical milestone base grows and matures, it will generate more milestones, and with a scalable infrastructure keeping expenses tight, additional revenue will drop to the bottom line, naturally closing the gap over time. Q: Can you provide color on how the number of post-discovery preclinical programs has evolved over the last six months and how you see that group growing through the end of the year?A: Matt Foehr (CEO) noted continued "nice progression" and "graduation" of programs across all stages, from discovery to preclinical and into the clinic. He confirmed that four new programs entered the clinic this year, with more expected before year-end. He also mentioned that recent regulatory guidance changes around preclinical work for certain antibody programs could serve as a long-term tailwind, particularly for smaller partners, potentially accelerating the path to clinical entry. Q: Regarding the Exploration platform, what are you seeing from a utilization standpoint, and how is the sales pipeline shaping up? Will sales remain lumpy, or are you starting to see a more consistent cadence?A: Matt Foehr (CEO) stated the team remains "very excited" about the Exploration opportunity, with growing conviction that it will be a meaningful complement to the antibody business. He confirmed two units were sold in Q2, bringing the total to four in the field, but noted it's still early to discuss consumables trends. Amechi (President) added that differentiated life sciences instruments like the Exploration Platform have the potential to create diverse and durable revenue streams, including instruments, consumables, software, and service, with more details to be shared at the upcoming Investor Day. Q: With the improved funding environment for pharma and biotech, are you seeing that benefit already, or is there a lag? When might those dollars start to flow to you?A: Matt Foehr (CEO) observed "very nice growth in partners and programs net of attrition" over the last couple of years. He noted that larger partners are taking "bigger swings" at major indications with substantial unmet need, and there's an uptick in smaller, well-funded partners as well. He highlighted new licenses with Rosa Therapeutics and Argenix as examples of both emerging and global-leading partners ramping up activity, indicating the improved funding environment is already translating into new business. Q: How should we think about the relative impact of Exploration sales on margins as that product ramps up?A: Kurt (CFO) explained that the company has "very good margins on the instrument and even better margins on the consumables." He cautioned that quarterly margins could vary based on the mix of instrument, consumable, and service revenue, but emphasized that the overall margin profile is expected to remain strong and continue. Q: Has Omni Ultra been a big focus in partner conversations? What has the feedback been, and how do you see its contribution to new deals over the next 12-18 months?A: Matt Foehr (CEO) stated that Omni Ultra is "absolutely opening new markets" and driving substantial inbound interest, alongside OmniAb. He highlighted its dual modality for antibodies and peptides, and its applicability in high-value areas like ion channels and GPCRs, as well as for brain shuttling and multi-specifics. He expressed pleasure with the dialogue and the signing of new programs, expecting to share more as partners begin discussing data. Q: The raised guidance implies lower revenue in the back half of the year. How much of that is conservatism versus one-off dynamics in the front half?A: Kurt (CFO) clarified that milestone achievements are "front end loaded for 2026," which is the primary driver of the revenue pattern. He emphasized there is nothing negative happening in other revenue lines; in fact, service revenue is expected to be better in 2026 than in 2025. He declined to provide more granular guidance but indicated the back-half expectations are based on the current visibility of milestone timing. Q: Can you provide color on your portfolio's exposure to lab-in-the-loop and AI for antibody drug discovery? How is OmniAb leveraging that, and to what extent is it influencing the business now?A: Matt Foehr (CEO) reiterated the company's strong belief in AI as a tailwind, referencing the OmniDeep brand launched over three years ago. He explained that AI/ML tools are woven throughout the technology stack, starting with proprietary, high-quality input data from transgenic animalstermed "biological intelligence." The Exploration platform generates massive datasets of hits and misses that feed deep learning models to suggest new hits, driving efficiency. He sees this as a powerful combination for navigating the growing number of novel targets, accelerating drug discovery. Q: How do you feel about the pace of deal flow going forward? Is this a model that accelerates with time, or stays steady with greater value? How should we think about the OmniAb model on a 3-5 year horizon?A: Matt Foehr (CEO) pointed to the company's track record of growing programs and partners net of attrition even during industry headwinds, which speaks to the differentiation of its technologies. He highlighted that partners are progressing programs into the clinic, with some late-stage programs described as "pipeline in a product." He emphasized that while milestones will continue to grow, the layering in of royaltiesmany of which are tieredwill add significant power to the model over the long term. Q: Congratulations on the Exploration sales. Given the few in the ecosystem, what are you seeing from a utilization standpoint?A: Matt Foehr (CEO) reiterated excitement about the Exploration opportunity, noting it's contributing to revenue growth. While it's still early to discuss consumables, he confirmed two units were sold in the quarter, bringing the total to four in the field. Amechi (President) added that the platform has the potential to create diverse, durable revenue streams, and the company will share For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-07-28argenx (ENXTBR:ARGX) Stock Looks Fairly Valued With Modest Upside On Earnings
Simply Wall St.
argenx (ENXTBR:ARGX) Stock Looks Fairly Valued With Modest Upside On Earnings
Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St. argenx stock has delivered a very strong 202.6% return over the past five years, yet its current valuation checks point to a more mixed picture rather than a clear bargain or clear overvaluation. With the share price around US$789.80 and expectations building around its immunology pipeline and recent deals, investors are weighing how much of that story is already reflected in the valuation. A 202.6% five year return shows argenx has already rewarded long term holders, which raises the bar for any further upside to be justified by fundamentals. The planned US$2.2b acquisition of Forte Biosciences and the push to broaden Vyvgart indications can support long term revenue expectations. At the same time, integration risk and execution across a larger pipeline may limit how much investors are prepared to pay today. A value score of 4 out of 6 suggests argenx screens as neither plainly cheap nor clearly expensive on the wider set of valuation checks. The issue now is whether argenx's current price already reflects its growth ambitions in immunology or still leaves room for further return over time. argenx delivered 54.3% returns over the last year. See how this stacks up to the rest of the Biotechs industry. P/E is a useful check for argenx because it already reports earnings and is valued as a commercial immunology business rather than a purely early stage biotech. On this measure, argenx trades on a P/E of about 32.7x, which is above the broader biotech industry average of roughly 25.8x but below the peer group average of about 67.5x. The Fair P/E Ratio for argenx is estimated at around 37.6x, based on its size, profitability profile and risk. That is higher than today’s 32.7x, which suggests some headroom before the multiple would line up with this tailored benchmark. Despite the recent Forte Biosciences acquisition announcement raising interest in argenx and its pipeline, the current P/E still sits at a discount to the level suggested by this fair value yardstick. On balance, argenx stock appears undervalued on the P/E multiple compared with the Fair Ratio benchmark. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives for argenx pick up where this valuation puzzle leaves off. They explain…Read full documentShow less
Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St. argenx stock has delivered a very strong 202.6% return over the past five years, yet its current valuation checks point to a more mixed picture rather than a clear bargain or clear overvaluation. With the share price around US$789.80 and expectations building around its immunology pipeline and recent deals, investors are weighing how much of that story is already reflected in the valuation. A 202.6% five year return shows argenx has already rewarded long term holders, which raises the bar for any further upside to be justified by fundamentals. The planned US$2.2b acquisition of Forte Biosciences and the push to broaden Vyvgart indications can support long term revenue expectations. At the same time, integration risk and execution across a larger pipeline may limit how much investors are prepared to pay today. A value score of 4 out of 6 suggests argenx screens as neither plainly cheap nor clearly expensive on the wider set of valuation checks. The issue now is whether argenx's current price already reflects its growth ambitions in immunology or still leaves room for further return over time. argenx delivered 54.3% returns over the last year. See how this stacks up to the rest of the Biotechs industry. P/E is a useful check for argenx because it already reports earnings and is valued as a commercial immunology business rather than a purely early stage biotech. On this measure, argenx trades on a P/E of about 32.7x, which is above the broader biotech industry average of roughly 25.8x but below the peer group average of about 67.5x. The Fair P/E Ratio for argenx is estimated at around 37.6x, based on its size, profitability profile and risk. That is higher than today’s 32.7x, which suggests some headroom before the multiple would line up with this tailored benchmark. Despite the recent Forte Biosciences acquisition announcement raising interest in argenx and its pipeline, the current P/E still sits at a discount to the level suggested by this fair value yardstick. On balance, argenx stock appears undervalued on the P/E multiple compared with the Fair Ratio benchmark. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives for argenx pick up where this valuation puzzle leaves off. They explain what would need to be true about argenx's future growth, margins and earnings for the stock to be worth materially more or less than today’s price. Each narrative focuses on the assumptions behind its fair value so you can compare those with how the business actually performs over time. The community is split on argenx, with one camp seeing meaningful upside left in the story and the other warning the stock already bakes in a lot of good news. Bull case: 11% undervalued Read the full Bull Case to see why argenx could be undervalued Bear case: 15% overvalued Read the full Bear Case to see why argenx could be overvalued Do you think there's more to the story for argenx? Head over to our Community to see what others are saying! argenx screens as undervalued on its current P/E relative to the tailored fair multiple, yet the broader valuation checks sit in a mixed zone rather than clearly cheap. That combination leaves the stock looking more like a balanced risk and reward trade off rather than a straightforward value idea. The key question from here is whether argenx can deliver on its immunology pipeline and manage the Forte Biosciences integration cleanly enough for earnings and confidence to grow into, or beyond, the current multiple. 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 ARGX.BR. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-07-23argenx Reports Half Year 2026 Financial Results and Provides Second Quarter Business Update
GlobeNewswire
argenx Reports Half Year 2026 Financial Results and Provides Second Quarter Business Update
Strong second quarter performance with $1.5 billion in global product net sales, representing 60% year-over-year growth and 17% quarter-over-quarter growth Successfully launched VYVGART and VYVGART Hytrulo in anti-AChR antibody negative (“seronegative”) gMG, expanding patient reach to all gMG serotypes Registrational autoimmune myositis study readout on track for 3Q26, marking a key milestone for VYVGART expansion into rheumatology Registrational MMN study readout for empasiprubart on track for 4Q26, supporting a second pipeline-in-a-product opportunity Management to host conference call today at 2:30 PM CET (8:30 AM ET) July 23, 2026 7:00 AM CET Amsterdam, the Netherlands - argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, today announced its half year 2026 results and provided a second quarter business update. “Our strong second quarter performance reflects continued execution of our Vision 2030 strategy and our commitment to accelerate immunology innovation,” said Karen Massey, Chief Executive Officer. “During the quarter, we further strengthened our leadership in FcRn with the launch of the expanded label for VYVGART and VYVGART Hytrulo to now include all gMG serotypes, providing physicians with a single treatment option for the broadest adult gMG patient population. With important registrational study readouts in the second half, as well as continued progress with our early-stage pipeline, we are advancing the next wave of innovation, reinforcing our ambition to build a leading multi-asset immunology company.” Vision 2030argenx continues to advance its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into registrational development by 2030. Expanding global VYVGART opportunity and shaping the long-term future of FcRnVYVGART® (IV: efgartigimod alfa-fcab; SC: efgartigimod alfa and hyaluronidase-qvfc) is the first-and-only approved treatment for all serotypes of adult patients living with generalized myasthenia gravis (gMG). It is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. As the leading targeted biologic in MG and CIDP, argenx is progressing multiple label expansions while building the future of FcRn by advancing novel FcRn p…Read full documentShow less
Strong second quarter performance with $1.5 billion in global product net sales, representing 60% year-over-year growth and 17% quarter-over-quarter growth Successfully launched VYVGART and VYVGART Hytrulo in anti-AChR antibody negative (“seronegative”) gMG, expanding patient reach to all gMG serotypes Registrational autoimmune myositis study readout on track for 3Q26, marking a key milestone for VYVGART expansion into rheumatology Registrational MMN study readout for empasiprubart on track for 4Q26, supporting a second pipeline-in-a-product opportunity Management to host conference call today at 2:30 PM CET (8:30 AM ET) July 23, 2026 7:00 AM CET Amsterdam, the Netherlands - argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, today announced its half year 2026 results and provided a second quarter business update. “Our strong second quarter performance reflects continued execution of our Vision 2030 strategy and our commitment to accelerate immunology innovation,” said Karen Massey, Chief Executive Officer. “During the quarter, we further strengthened our leadership in FcRn with the launch of the expanded label for VYVGART and VYVGART Hytrulo to now include all gMG serotypes, providing physicians with a single treatment option for the broadest adult gMG patient population. With important registrational study readouts in the second half, as well as continued progress with our early-stage pipeline, we are advancing the next wave of innovation, reinforcing our ambition to build a leading multi-asset immunology company.” Vision 2030argenx continues to advance its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into registrational development by 2030. Expanding global VYVGART opportunity and shaping the long-term future of FcRnVYVGART® (IV: efgartigimod alfa-fcab; SC: efgartigimod alfa and hyaluronidase-qvfc) is the first-and-only approved treatment for all serotypes of adult patients living with generalized myasthenia gravis (gMG). It is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. As the leading targeted biologic in MG and CIDP, argenx is progressing multiple label expansions while building the future of FcRn by advancing novel FcRn pipeline candidates and new delivery modalities. Generated $1.5 billion in global product net sales in the second quarter of 2026, representing 17% quarter-over-quarter growth, and a year-over-year increase of 60% or $0.6 billion Launched expanded label for VYVGART and VYVGART Hytrulo® in the U.S., which now includes all gMG serotypes (anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative) On track with plans to expand VYVGART into ocular myasthenia gravis (oMG) following positive ADAPT OCULUS results Topline results from registrational ALKIVIA study (myositis) expected in third quarter of 2026 Topline results from registrational ADVANCE-NEXT study (primary ITP) expected in first half of 2027 Topline results from registrational UNITY study (Sjogren’s disease) expected in second half of 2027 Registrational study in Graves’ disease (GD) ongoing, expanding development into thyroid-driven autoimmunity VYVGART SC autoinjector positioned to launch in 2027 for all approved indications Progressing two future FcRn molecules: ARGX-213, designed for monthly dosing, is Phase 3 ready, and ARGX-124 is expected to complete Phase 1 evaluation by end of 2026 Advancing empasiprubart, argenx’s second pipeline-in-a-product opportunityEmpasiprubart (anti-C2) is argenx’s second pipeline-in-a-product opportunity and is being evaluated in registrational studies in multifocal motor neuropathy (MMN) and CIDP, and in a combination study with VYVGART in gMG. Topline results from registrational EMPASSION study (MMN) expected in fourth quarter of 2026 Topline results from registrational EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027 Data from Phase 2 VARVARA study (delayed graft function, DGF) support further evaluation of empasiprubart in transplant setting based on signal at 52 weeks Advancing ADAPT-Forward combination study, evaluating empasiprubart as a potential add-on therapy to efgartigimod in gMG Delivering next wave of immunology innovationBy the end of 2026, argenx expects to have ten molecules in clinical development across its immunology pipeline, including adimanebart (MuSK agonist), ARGX-121 (anti-IgA), ARGX-109 (anti-IL-6) and additional candidates emerging from the Immunology Innovation Program. Together, these programs support argenx's goal of building a durable pipeline of differentiated medicines. Phase 2 study of adimanebart in spinal muscular atrophy (SMA) ongoing; registrational study in congenital myasthenic syndromes (CMS) expected to begin in 2026 Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) expected to start in 2026 First-in-human Phase 1 study of TSP-101 (Fn14 inhibitor) is ongoing ARGX-118 (Galectin-10 inhibitor) and ARGX-125 (first-in-class bispecific antibody against an undisclosed target) are on track to enter Phase 1 studies in 2026 SECOND QUARTER 2026 FINANCIAL RESULTS argenx SEUNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS *Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of research and development expenses and loss from investment in a joint venture. DETAILS OF THE FINANCIAL RESULTS Total operating income for the three and six months ended June 30, 2026, was $1.5 billion and $2.9 billion, respectively, compared to $1.0 billion and $1.8 billion, respectively, for the same periods in 2025, and mainly consists of: Product net sales of VYVGART for the three and six months ended June 30, 2026, were $1.5 billion and $2.8 billion, respectively, compared to $0.9 billion and $1.7 billion, respectively, for the same periods in 2025. Other operating income for the three and six months ended June 30, 2026, was $26 million and $41 million, respectively, compared to $19 million and $36 million, respectively, for the same periods in 2025. The other operating income for the three and six months ended June 30, 2026 and 2025, primarily relates to research and development tax incentives and payroll tax rebates. Total operating expenses for the three and six months ended June 30, 2026 were $1.0 billion and $2.0 billion, respectively, compared to $0.8 billion and $1.4 billion, respectively, for the same periods in 2025, and mainly consist of: Cost of sales for the three and six months ended June 30, 2026, was $145 million and $266 million, respectively, compared to $111 million and $192 million for the same periods in 2025, respectively. The cost of sales was related to the sale of VYVGART. Research and development expenses for the three and six months ended June 30, 2026, were $0.5 billion and $0.9 billion, respectively, compared to $0.3 billion and $0.6 billion, respectively, for the same periods in 2025. The research and development expenses mainly relate to advancing efgartigimod, empasiprubart, and adimanebart across multiple registrational studies, plus early-stage pipeline and preclinical programs. Selling, general and administrative expenses for the three and six months ended June 30, 2026, were $0.4 billion and $0.8 billion, respectively, compared to $0.3 billion and $0.6 billion, respectively, for the same periods in 2025. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of the VYVGART franchise, and personnel expenses. Financial income for the three and six months ended June 30, 2026, was $48 million and $92 million, respectively, compared to $38 million and $76 million, respectively, for the same periods in 2025. Income tax for the three and six months ended June 30, 2026 and 2025 is detailed below: Profit for the three and six-month periods ended June 30, 2026, was $0.5 billion and $0.8 billion, respectively, compared to a profit of $0.2 billion and a loss of $0.4 billion, respectively, for the same periods in 2025. The basic profit per share was $7.58 for the three months ended June 30, 2026, compared to a basic profit per share of $4.02 for the same period in 2025. The basic profit per share was $13.47 for the six months ended June 30, 2026, compared to a basic loss per share of $6.80 for the same period in 2025. Cash flow from operating activities for the six months ended June 30, 2026 was $0.7 billion compared to a cash flow used in operating activities for the same period in 2025 of $0.4 billion. Cash, cash equivalents and current financial assets1 consisted of $3.6 billion in cash, cash equivalents and $1.6 billion in current financial assets which totaled $5.2 billion as of June 30, 2026, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025. EXPECTED FINANCIAL CALENDAR October 22, 2026: Third Quarter 2026 Financial Results and Business Update February 25, 2027: Full-year 2026 Financial Results and Fourth Quarter 2026 Business Update CONFERENCE CALL DETAILSThe half-year 2026 financial results and second quarter business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. Participants can access the conference call by dialing 800-590-8290 (United States and Canada) or 240-690-8800 (International). Country specific dial-in numbers are listed below: Belgium 32 2290 4635France 33 172 001717Netherlands 31 20 795 2683United Kingdom 44 203 393 1560Japan 81 3 4520 9761Switzerland 41 43 210 51 68 Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call. A replay of the webcast will be available on the argenx website. About VYVGART VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo® is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube. This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). ContactsMedia:Ben [email protected] Investors:Alexandra Roy [email protected] Forward Looking StatementsThe contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements generally can be identified by the use of forward-looking words, such as “aim”, “anticipate”, “aspire”, “believe”, “can”, “continue”, “could”, “estimate”, “expect”, “entail”, “forecast”, “future”, “goals”, “hope”, “intend”, “is designed to”, “likely”, “may”, “might”, “objective”, “plan”, “possible”, “potential”, “pursue”, “project”, “predict”, “seek”, “should”, “strategy”, “target”, “will” and other words and terms of similar meaning and expression, including in connection with any discussion of future operating or financial performance. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the initiation, timing, progress, development and results of preclinical and clinical trials of argenx’s product candidates, including new indications, alternative dosing regimens, treatment modalities, and methods of administration, including statements regarding when results or interim analysis of the clinical trials will be available or made public; the expansion of argenx’s business, including the further development of argenx’s sales and marketing abilities and its Immunology Innovation Program, and the value of its pipeline; the potential attributes, benefits, and side effects of argenx’s products and product candidates, including new indications, alternative dosing regimens and treatment modalities, and their competitive position with respect to other alternative treatments; argenx’s ability to advance product candidates into, and successfully complete, clinical trials; argenx’s estimates of the number of patients who suffer from the diseases it is targeting and the number of patients that will enroll in its clinical trials; the demand and commercialization of argenx’s products and product candidates, including new indications, alternative dosing regimens, treatment modalities, and methods of administration, if approved; the anticipated timing or likelihood of market or regulatory decisions relating to or of argenx’s products, including new indications, alternative dosing regimens, treatment modalities, and methods of administration; the anticipated pricing and reimbursement of argenx’s products and product candidates, if approved; argenx’s plans to have various programs to help patients afford its products, including patient assistance and co-pay coupon programs for eligible patients; argenx’s ability to establish sales, marketing and distribution capabilities for any of its products and product candidates that achieve regulatory approval; argenx’s regulatory strategy and its ability to establish and maintain manufacturing arrangements for its products and product candidates; the scope and duration of protection, including any exclusivity period, argenx is able to establish and maintain for intellectual property rights covering its products and product candidates, platform and technology, including its intention to seek patent term extensions where available; argenx’s estimates regarding expenses, future revenues, cash flow, capital requirements and its needs for additional financing; argenx’s expectation that it will benefit from the Belgian innovation income deduction; argenx’s financial performance, including potential volatility in the price of its ordinary shares and American Depositary Shares; the competition argenx faces in its drug discovery, development, and commercialization efforts; the rate and degree of market acceptance of argenx’s products and product candidates, if approved, by its patients as safe, effective and cost-effective; the potential benefits of argenx’s current collaborations, including the possibility to access partner technology platforms or capabilities; argenx’s plans and ability to enter into or maintain current collaborations for additional programs or product candidates; argenx’s plans and ability to enter into or maintain current new distribution partnerships; argenx’s long-term growth strategy to develop and market additional products and product candidates, including efgartigimod for new indications, empasiprubart and adimanebart; the impact of government laws and regulations, including tariffs, export controls, sanctions and other regulations on argenx’s business; argenx’s expectations with respect to the timing and amount of any dividends (if any); argenx’s plans regarding its supply chain, including its reliance on third parties, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; regional instability and conflicts; and argenx’s business strategies, including Vision 2030, plans, projects, goals and targets and the timing, outcomes and benefits thereof. A further list and description of these and other risks, uncertainties, and factors that could cause actual results to differ materially from those referred to in the forward-looking statements can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these risks and uncertainties, the reader is advised not to place undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press release. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. Alternative Performance Measures StatementIn this document, argenx's financial results are provided in accordance with IFRS® Accounting Standards (IFRS) and using a non-IFRS financial measure, cash, cash equivalents and current financial assets. This value should not be viewed as a substitute for the company’s IFRS financial information and is provided as a complement to financial information provided in accordance with IFRS and should be read in conjunction with the most directly comparable IFRS financial information as set out below. Management believes this non-IFRS financial measure is useful for securities analysts, investors and other interested parties to gain a more complete understanding of the company's available financial liquidities given that the company’s current financial assets are held in term accounts with an initial maturity of more than three months but less than twelve that may be used to meet its financial obligations. Such non-IFRS financial information, as calculated herein, may not be comparable to similarly named measures used by other companies and should not be considered comparable to IFRS financial measures. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, an analysis of the company's financial results as reported under IFRS. A reconciliation of the IFRS financial information to non-IFRS financial information is included below: Cash, cash equivalents and current financial assets totaled $5.2 billion as of June 30, 2026, compared to $4.4 billion as of December 31, 2025. The balance as of the period ended June 30, 2026 consisted of $3.6 billion in cash, cash equivalents and $1.6 billion in current financial assets and the balance as of the period ended December 31, 2025 consisted of $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets. 1 A non-IFRS Alternative Performance Measure (APM). Refer to the “Alternative Performance Measures Statement” below for a reconciliation to the IFRS financial information.
Investor releaseQuarter not tagged2026-07-23argenx SE (ARGNF) Q2 2026 Earnings Call Highlights: Robust Growth and Strategic Advances
GuruFocus.com
argenx SE (ARGNF) Q2 2026 Earnings Call Highlights: Robust Growth and Strategic Advances
This article first appeared on GuruFocus. Product Net Sales: $1.5 billion for Q2 2026, 60% year-over-year growth, 17% quarter-over-quarter growth. US Product Net Sales: $1.3 billion, 15% quarter-over-quarter growth. Japan Product Net Sales: $102 million, 55% quarter-over-quarter growth, including a $25 million one-off benefit. Operating Expenses: $1 billion for Q2 2026, an increase of $129 million from Q1. R&D and SG&A Investment: $903 million in Q2 2026. Operating Profit: $494 million, 146% year-over-year increase. Tax Rate: 11% of profit before tax for the quarter. Cash Balance: $5.2 billion at the end of Q2 2026, an increase of $744 million from the beginning of the year. Warning! GuruFocus has detected 5 Warning Sign with ARGNF. Is ARGNF fairly valued? Test your thesis with our free DCF calculator. Release Date: July 23, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. argenx SE (ARGNF) reported its 18th consecutive quarter of growth, highlighting strong momentum and consistent performance. VYVGART has been approved for seronegative generalized Myasthenia Gravis (gMG), making it the first treatment approved across all serotypes of gMG. The company achieved a 60% year-over-year growth in product net sales, with significant contributions from the US, Japan, and other regions. argenx SE (ARGNF) has a robust pipeline with two registrational readouts expected before the end of the year, supporting its goal of achieving 10 labeled indications. The company maintains a strong financial position with a cash balance of $5.2 billion, allowing for reinvestment in scientific innovation and potential business development opportunities. Total operating expenses increased by $129 million compared to the first quarter, reflecting higher R&D and SG&A investments. The company faces competition in the MG market, with new launches and upcoming launches from competitors potentially impacting market share. There are concerns about the efficacy and safety of FcRn therapies, with some competitors suggesting potential dropouts due to safety observations. The development of Empasiprubart in the transplant setting did not support DGF as an indication, indicating challenges in expanding its use. The company faces challenges in changing entrenched habits among physicians and payers to adopt VYVGART as a first-line treatment for…Read full documentShow less
This article first appeared on GuruFocus. Product Net Sales: $1.5 billion for Q2 2026, 60% year-over-year growth, 17% quarter-over-quarter growth. US Product Net Sales: $1.3 billion, 15% quarter-over-quarter growth. Japan Product Net Sales: $102 million, 55% quarter-over-quarter growth, including a $25 million one-off benefit. Operating Expenses: $1 billion for Q2 2026, an increase of $129 million from Q1. R&D and SG&A Investment: $903 million in Q2 2026. Operating Profit: $494 million, 146% year-over-year increase. Tax Rate: 11% of profit before tax for the quarter. Cash Balance: $5.2 billion at the end of Q2 2026, an increase of $744 million from the beginning of the year. Warning! GuruFocus has detected 5 Warning Sign with ARGNF. Is ARGNF fairly valued? Test your thesis with our free DCF calculator. Release Date: July 23, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. argenx SE (ARGNF) reported its 18th consecutive quarter of growth, highlighting strong momentum and consistent performance. VYVGART has been approved for seronegative generalized Myasthenia Gravis (gMG), making it the first treatment approved across all serotypes of gMG. The company achieved a 60% year-over-year growth in product net sales, with significant contributions from the US, Japan, and other regions. argenx SE (ARGNF) has a robust pipeline with two registrational readouts expected before the end of the year, supporting its goal of achieving 10 labeled indications. The company maintains a strong financial position with a cash balance of $5.2 billion, allowing for reinvestment in scientific innovation and potential business development opportunities. Total operating expenses increased by $129 million compared to the first quarter, reflecting higher R&D and SG&A investments. The company faces competition in the MG market, with new launches and upcoming launches from competitors potentially impacting market share. There are concerns about the efficacy and safety of FcRn therapies, with some competitors suggesting potential dropouts due to safety observations. The development of Empasiprubart in the transplant setting did not support DGF as an indication, indicating challenges in expanding its use. The company faces challenges in changing entrenched habits among physicians and payers to adopt VYVGART as a first-line treatment for CIDP. Q: How might the future growth trajectory change with the launch in the seronegative population, and are there any tailwinds from the broader population now that most plans are not requiring serology testing? A: Beth DelGiacco, Vice President, Corporate Communications & Investor Relations, stated that the company expects the growth trajectory to remain consistent with prior years, despite the launch of the seronegative population. The seronegative launch is expected to contribute to growth, similar to previous launches like the pre-filled syringe. Q: What is the status of the ocular MG filing, and how could it impact VYVGART's revenue trajectory? A: Beth DelGiacco mentioned that the ocular MG filing is progressing with urgency due to the unmet need in this patient population. Sandrine Gerard, Chief Commercialization Officer, added that the potential approval could support growth momentum, as many ocular MG patients are treated by neurologists familiar with VYVGART. Q: Can you discuss the competitive landscape and any feedback from the field regarding VYVGART's efficacy and safety? A: Karen Massey, CEO, emphasized that argenx has maintained market leadership despite competition. Sandrine Gerard highlighted that VYVGART is used earlier in treatment lines due to its strong efficacy and safety profile, with 60% of patients achieving minimal symptom expression. Q: What should we expect from the myositis trial readout, and what is the potential path to filing, particularly in DM? A: Karen Massey explained that success in the myositis trial would be a positive readout on the primary endpoint in one or more subsets. The company sees both indications as potential blockbusters and strategically important for entering rheumatology. Q: Can you provide more details on the Empasiprubart development and its potential impact on MMN? A: Luc Truyen, Chief Medical Officer, stated that the Phase 2 study showed an in-treatment signal in renal parameters, but it does not support DGF as an indication. Karen Massey added that the most important data point for MMN is the positive Phase 2 study results. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-07-23argenex Q2 Earnings Call Highlights
MarketBeat
argenex Q2 Earnings Call Highlights
Interested in argenex SE? Here are five stocks we like better. argenx posted a strong quarter, with second-quarter product net sales rising 60% year over year to $1.5 billion and operating profit jumping 146% to $494 million. The company ended the quarter with $5.2 billion in cash and financial assets. VYVGART continues to drive growth across myasthenia gravis and CIDP, boosted by the expanded label for seronegative generalized MG. Management said the label expansion adds about 11,000 addressable patients and is already seeing broad payer coverage and strong physician adoption. The pipeline now takes center stage as argenx expects two registrational readouts before year-end 2026: VYVGART in autoimmune myositis and empasiprubart in MMN. The company also highlighted additional next-generation immunology programs and said it remains open to external deals to broaden beyond FcRn. 2 Ways to Play the Big Pharma Patent Cliff argenex (NASDAQ:ARGX) reported what executives described as one of its strongest quarters to date, driven by continued growth for VYVGART across myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, as well as early momentum from a newly expanded label in generalized myasthenia gravis. On the company’s second-quarter 2026 earnings call, Chief Executive Officer Karen Massey said argenx delivered its 18th consecutive quarter of growth and is advancing toward its Vision 2030 plan, which includes a goal of reaching 10 labeled indications and advancing five late-stage molecules by 2030. → 3 Photonics Companies Making Quantum Tech Possible 3 Healthcare Pathbreakers With Long-Term Tailwinds “The team delivered one of our strongest quarters yet,” Massey said. “This momentum reflects the value VYVGART continues to deliver for patients.” Chief Financial Officer Karl Gubitz said product net sales were $1.5 billion in the second quarter, up 60% from the prior year and 17% from the first quarter. U.S. product net sales totaled $1.3 billion, while Japan contributed $102 million, the rest of the world contributed $136 million, and product supply to Zai Lab in China accounted for $5 million. → Could Truth API Become Trump Media’s First Meaningful Revenue Driver? 5 medical stocks growing earnings by triple digits Gubitz said U.S. market growth was 15% quarter over quarter, with gross-to-net and net pricing similar to prior quarters. In Japan,…Read full documentShow less
Interested in argenex SE? Here are five stocks we like better. argenx posted a strong quarter, with second-quarter product net sales rising 60% year over year to $1.5 billion and operating profit jumping 146% to $494 million. The company ended the quarter with $5.2 billion in cash and financial assets. VYVGART continues to drive growth across myasthenia gravis and CIDP, boosted by the expanded label for seronegative generalized MG. Management said the label expansion adds about 11,000 addressable patients and is already seeing broad payer coverage and strong physician adoption. The pipeline now takes center stage as argenx expects two registrational readouts before year-end 2026: VYVGART in autoimmune myositis and empasiprubart in MMN. The company also highlighted additional next-generation immunology programs and said it remains open to external deals to broaden beyond FcRn. 2 Ways to Play the Big Pharma Patent Cliff argenex (NASDAQ:ARGX) reported what executives described as one of its strongest quarters to date, driven by continued growth for VYVGART across myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, as well as early momentum from a newly expanded label in generalized myasthenia gravis. On the company’s second-quarter 2026 earnings call, Chief Executive Officer Karen Massey said argenx delivered its 18th consecutive quarter of growth and is advancing toward its Vision 2030 plan, which includes a goal of reaching 10 labeled indications and advancing five late-stage molecules by 2030. → 3 Photonics Companies Making Quantum Tech Possible 3 Healthcare Pathbreakers With Long-Term Tailwinds “The team delivered one of our strongest quarters yet,” Massey said. “This momentum reflects the value VYVGART continues to deliver for patients.” Chief Financial Officer Karl Gubitz said product net sales were $1.5 billion in the second quarter, up 60% from the prior year and 17% from the first quarter. U.S. product net sales totaled $1.3 billion, while Japan contributed $102 million, the rest of the world contributed $136 million, and product supply to Zai Lab in China accounted for $5 million. → Could Truth API Become Trump Media’s First Meaningful Revenue Driver? 5 medical stocks growing earnings by triple digits Gubitz said U.S. market growth was 15% quarter over quarter, with gross-to-net and net pricing similar to prior quarters. In Japan, net product sales increased 55% sequentially, or $35 million, though reported sales included a one-time benefit of about $25 million tied to a distribution model change. Total operating expenses were $1 billion in the quarter, up $129 million from the first quarter. Combined research and development and selling, general and administrative expenses were $903 million, which Gubitz said reflected “disciplined investment” in clinical development and commercial capabilities. Operating profit was $494 million, up 146% year over year. The company ended the quarter with $5.2 billion in cash, cash equivalents and current financial assets, an increase of more than $744 million from the start of the year. → AeroVironment’s Stock Is Down, But Drone Demand Is Taking Off Chief Commercialization Officer Sandrine Piret-Gerard said VYVGART growth continued across both MG and CIDP and across all regions, with new patient demand remaining consistently high. She said the prefilled syringe has been an important driver of demand, with about 80% of U.S. prefilled syringe patients in the second quarter new to VYVGART. Piret-Gerard said the company now has a repeat prescriber base of more than 5,000 neurologists and is seeing increased use earlier in the treatment journey. In response to a question, she clarified that the 80% figure referred specifically to the second quarter, while the launch-to-date figure for prefilled syringe patients new to VYVGART was about 70%. Executives also highlighted the recent approval of VYVGART for seronegative generalized myasthenia gravis. Massey said the drug is now the first and only treatment approved across all serotypes of generalized MG, including triple seronegative patients. Piret-Gerard said the label expansion increases the addressable MG market by 11,000 patients and has generated positive feedback from patients and physicians. On payer coverage, Piret-Gerard said policies now cover about 55% of U.S. commercial lives within 10 weeks of launch, and most plans are removing serology testing requirements. She said the expanded label is also having a “halo effect” on broader gMG prescribing, including in seropositive patients. In CIDP, Piret-Gerard said argenx is working to expand beyond its initial 12,000-patient addressable population in the United States. She said about 24,000 U.S. patients are being treated for CIDP, with roughly half considered well managed on existing therapy, though the company believes many patients have adapted their lives around lost function. The company cited data from a phase 4 switch study presented at the Peripheral Nerve Society meeting showing that 87% of patients on IVIG switched successfully to VYVGART. Piret-Gerard also pointed to data presented at the American Academy of Neurology showing that 87.5% of treatment-naive CIDP patients benefited from a clinical response. She said VYVGART use in treatment-naive patients remains a developing opportunity, but adoption takes time because many physicians start patients on IVIG and many payers still require some IVIG experience. Massey said argenx has two registrational readouts expected before the end of 2026: VYVGART in autoimmune myositis and empasiprubart in multifocal motor neuropathy, or MMN. For autoimmune myositis, Massey said the company is on track for a third-quarter readout and is evaluating both immune-mediated necrotizing myopathy, or IMNM, and dermatomyositis, or DM. She said there are no approved treatments today for IMNM and that argenx has breakthrough designation from the FDA in that subtype. Chief Medical Officer Luc Truyen, who joined for the question-and-answer session, said the company will analyze the IMNM and DM subsets independently. Massey said success would be a positive readout on the primary endpoint in one or more subsets, and that both IMNM and DM could represent potential blockbuster indications on their own. For empasiprubart, Massey said the first registrational readout in MMN is expected later this year. Truyen said the phase 3 trial compares empasiprubart head to head against IVIG after patients are stabilized on IVIG, with grip strength as the endpoint. Massey said success would be a positive readout on the primary endpoint of non-inferiority, with superiority representing upside. Massey said argenx is also advancing additional pipeline candidates, including next-generation FcRn molecules ARGX-213 and ARGX-124, the IgA “sweeper” ARGX-121, and earlier-stage programs ARGX-118, ARGX-125 and TSP-101. She said ARGX-213 is “phase III-ready,” while ARGX-124 is in phase 1 and could be positioned for late-stage development by year-end. Discussing ARGX-121, Massey said phase 1 data showed about a 90% reduction in IgA within days, maintained through day 28 after a single dose. Truyen said key opinion leaders had responded enthusiastically to the depth and speed of IgA reduction as the company moves into IgA nephropathy. On business development, Massey said the company’s capital allocation strategy remains focused on fueling VYVGART growth, advancing the internal pipeline and using the strength of the balance sheet to pursue external opportunities. She said argenx is focused on immunology assets with novel biology and significant unmet patient need, while seeking to diversify beyond FcRn. “We hold the bar high,” Massey said, “but I can tell you when we find those opportunities where we can have an impact for patients, we will leverage the flexibility of the balance sheet to be able to go after them.” argenx (NASDAQ: ARGX) is a biotechnology company focused on the discovery, development and commercialization of antibody-based therapeutics for severe autoimmune and neuromuscular diseases. The company uses its proprietary SIMPLE Antibody platform to generate differentiated antibodies and engineered Fc regions, and it pursues mechanisms that modulate the neonatal Fc receptor (FcRn) to reduce pathogenic IgG levels. Argenx's research and development activities span target identification, preclinical development and late-stage clinical programs aimed at addressing unmet needs in immunology. The company's lead product, efgartigimod (marketed as Vyvgart), is an FcRn antagonist developed to reduce circulating IgG antibodies and treat IgG-mediated disorders. 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 "argenex Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.
TranscriptFY2026 Q22026-07-23FY2026 Q2 earnings call transcript
Earnings source - 123 paragraphs
FY2026 Q2 earnings call transcript
Good morning. My name is Layla, and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. Thank you. I would like to introduce Beth DelGiacco, Vice President of Corporate Affairs. You may now begin your call.
Thank you. A press release was issued earlier today with our second quarter 2026 financial results and business update. This can be found on our website along with the presentation for today's webcast. Before we begin on slide two, I would like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. argenx is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I am joined on the call today by Karen Massey, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Sandrine Piret-Gerard, Chief Commercialization Officer. Luc Truyen, Chief Medical Officer, will be available during the Q&A.
I will now turn the call over to Karen.
Thank you, Beth, and welcome everyone. I will begin on slide three. The team delivered one of our strongest quarters yet, marking our 18th consecutive quarter of growth. This momentum reflects the value VYVGART continues to deliver for patients. The continued expansion of both MG and CIDP markets and our ability to unlock new opportunities for growth, most recently with the seronegative MG approval. The progress we are seeing across the business brings us closer to realizing Vision 2030, our roadmap for delivering near, medium, and long-term growth.
Looking ahead, we have two registrational readouts before year-end, which support our goal of achieving 10 labeled indications. Together with our differentiated immunology pipeline, these programs position us to extend our growth well beyond 2030. Our success today creates the opportunity to reinvest in the best science we can find wherever we can find it, fueling the next phase of argenx growth. Slide four.
VYVGART continues to change what is possible for patients with MG and CIDP, and we see strong growth across both indications in all regions. We're reaching more patients than ever before, driven by our commitment to bring meaningful innovation to the treatment experience. Last year, we introduced our prefilled syringe, expanding our prescriber base and supporting our goal to reach patients earlier in their treatment journey. This year, we reached another important milestone with the approval of VYVGART for seronegative gMG. VYVGART is now the first and only treatment approved across all serotypes of gMG, including for triple seronegative patients who previously had no approved treatment option. This is transformational for patients and physicians, removing the need for testing. With ocular MG ahead, we are moving forward in our ambition to make VYVGART the treatment of choice across all MG patients. Slide five.
We have two important readouts ahead that represent the next chapter of our growth strategy, broadening our leadership in neurology with empasiprubart and extending the impact of FCRN into new therapeutic areas, starting with rheumatology. VYVGART has the potential to have a similar impact in rheumatology as it has had in neurology. Autoimmune myositis is our entry point. It represents both a near-term label expansion opportunity and the foundation for long-term leadership. What continues to motivate us is the urgent patient need. In IMNM, patients can progress from their first symptoms to needing a wheelchair within a matter of months. We heard this at R&D Day. There are no approved treatments today. This sense of urgency to deliver for patients is what is driving our filing strategy based on the benefit-risk of each subtype on its own.
We saw a clear signal in both IMNM and DM in the phase II, we're on track for a readout this quarter. Myositis is just the beginning. We believe a first-in-class launch in myositis can establish the foundation for broader leadership in rheumatology with data expected in the second half of 2027. Slide six. empasiprubart remains on track to become our second pipeline in a product with our first registrational readout in MMN expected later this year. MMN represents one of the clearest unmet needs in neurology. empasiprubart has the potential to offer a differentiated approach supported by the efficacy, durability, and safety profile observed in the phase II ARDA study. We continue to see growing enthusiasm from the neurology community, particularly around the safety profile and the sustained improvements in grip strength observed in the open label extension. These are outcomes that matter in patients' daily lives.
Our ambition extends well beyond MMN. The unique biology of C2 inhibition has the potential to benefit a broader range of patients. From our ongoing phase III program in CIDP to our combination study in MG. We are focused on unlocking the full potential of this mechanism for patients. Slide seven. It's an incredibly exciting time to be building a company around scientific innovation. The pace of discovery is accelerating, our job is to find the most promising science that can change outcomes for patients. Our goal is to advance five late-stage molecules by 2030 to fuel long-term growth, we are pursuing this through two pathways. We're extending our leadership in FCRN, we're broadening our immunology pipeline. We are already delivering against this strategy. Our future FCRN molecules, ARGX-213 and ARGX-124, as well as our IgA sweeper, ARGX-121, are progressing towards late-stage development
ARGX-118, ARGX-125, and TSP-101, now in phase I, each represent new pipeline and product opportunities. Together, these investments reflect a disciplined capital allocation strategy focusing on delivering durable growth over the long term. With that, I'll turn the call over to Karl.
Thank you, Karen. Slide eight. I am pleased to present the second quarter 2026 financial results in this morning's press release. We continue to increase the number of patients that we treat, resulting in growing revenues. Product net sales for the second quarter were $1.5 billion, representing 60% year-over-year growth and 17% quarter-over-quarter growth. By region, product net sales were $1.3 billion in the U.S., $102 million in Japan, $136 million across the rest of the world, and $5 million related to product supply to Zai Lab in China. Our U.S. market grew by 15% quarter-over-quarter, with a gross-to-net and net pricing similar to prior quarters. In Japan, quarter-over-quarter net product sales growth is 55% or $35 million. Reported sales include a one-off benefit of approximately $25 million due to a change in our distribution model. Next slide nine.
Total operating expenses in the second quarter were $1 billion, representing an increase of $129 million compared to the first quarter. We have stepped up our combined R&D and SG&A investment to $903 million in the quarter. This increase is deliberate and reflects disciplined investment in multiple mid- and late-stage clinical development programs and commercialization capabilities to support our growing multiproduct portfolio. Operating profit in the second quarter is $494 million, an increase of 146% year-over-year. Tax for the quarter is 11% of profit before tax. We ended the quarter with a cash balance of $5.2 billion, including cash equivalents, and current financial assets, an increase of more than $744 million from the beginning of the year. Our capital allocation priority continues to be building durable long-term revenue growth.
At the same time, we are well on track to deliver a financial profile that includes increasing operating margins, sustained earnings growth, and a significant cash generation. I now turn the call over to Sandrine, who will provide details on the commercial front.
Thank you, Karl. I'll begin on slide 10. What continues to set argenx apart is our ability to translate the patient-first approach into execution across the entire treatment journey. From educating healthcare providers to supporting patients through ongoing care, we are focused on removing friction at every step. This is an approach that continues to deliver results. More HCPs are choosing to prescribe Vyvgart as their preferred biologics for MG and CIDP. More patients are requesting Vyvgart, and as a result, getting on treatment earlier. Patients are remaining on treatment because Vyvgart continues to make a meaningful difference in how they feel and function in their daily lives. Today, we have patients who started in our very first quarter of launch and remain on therapy 18 quarters later. These strong fundamentals are reflected in our performance this quarter, and they continue to position us well for future growth.
Slide 11. This quarter, we continue to see growth driven by both MG and CIDP across all regions, with new patient demand remaining at a consistently high level. The prefilled syringe continues to be an important driver of this demand across both MG and CIDP. Its convenience and flexibility are supporting broader adoption of Vyvgart. In the second quarter, approximately 80% of prefilled syringe patients in the U.S. have been new to Vyvgart. We also see increasing breadth and depth of prescriptions for Vyvgart. Physician confidence in Vyvgart is reflected in a repeat prescriber base of more than 5,000 neurologists and increasing use earlier in the treatment journey. While early into launch, we also saw a contribution to growth from our seronegative expansion in gMG. Vyvgart is now the first and only biologic approved across all serotypes of generalized MG, significantly expanding our addressable market in MG by 11,000 patients.
Slide 12. Our recent approval across all serotypes of gMG, MuSK positive, triple seronegative, and LRP4 positive, strengthens Vyvgart's leadership in MG and advances our goal of reaching the broadest patient population. We are pleased with the early response to the label expansion, with extremely positive patient and HCP feedback. We have established relationships with more than 80% of seronegative MG treaters and see the recent Vyvgart label expansion having a halo effect on all gMG prescriptions, also driving increased uptake by prescribers in the seropositive population. On the payer side, we leverage the credibility and relationship we have built to secure policies covering approximately 55% of U.S. commercial lives, all within 10 weeks since launch. Most plans are removing the serology testing requirement, making it simpler for physicians to prescribe VYVGART as the go-to option in MG.
There is also tremendous excitement and hope among patients, particularly triple seronegative patients who previously had no approved therapies available. One of these patients, Zach, shared, "I shut off my computer and cried. Hope. This is finally real hope for the seronegative community." As we look ahead in MG, we see significant opportunity to reach patients earlier in the treatment journey and, pending approval, expand into ocular MG. These patients continue to face a meaningful burden of disease, underscoring the need for additional treatment options and reinforcing our commitment to serving the full MG community. Slide 13. Let's move to the opportunity in CIDP. Within our initial 12,000-patient addressable population in the U.S., we are driving further adoption through physician education and continued evidence generation. At the same time, we are laying out the groundwork to expand beyond this.
Today, approximately 24,000 patients are being treated for CIDP in the U.S., and roughly half are considered well managed on their current therapy. Yet, what we consistently hear is that many have learned to live around their disease, often without realizing how much function they have lost. This is exactly why generating data that shows meaningful functional improvement matters. Our GRIT-strong results demonstrate the impact VYVGART can have on outcomes that are important in patients' daily life and meaningful to the physicians treating them. Similarly, we have generated evidence that helps physicians navigate practical treatment decisions, including transitioning appropriate patients from IVIG to VYVGART. We presented recently at PNS the results of our phase IV switch study showing that 87% of patients on IVIG switched successfully to VYVGART, helping address the question, how do I switch from IVIG to VYVGART?
We continue to explore the opportunity to reach patients earlier in their disease journey. We see significant potential among the large population of untreated patients, where all data suggests that treatment-naive patients may derive meaningful benefits from earlier treatment. Slide 14. Looking ahead, we are preparing the organization for the next wave of growth. We view autoimmune myositis as a strategic entry point into rheumatology, with the potential for VYVGART to establish early leadership as the first sSARM. We are augmenting our best-in-class launch playbook in MG and CIDP to be launch-ready for myositis. We are already engaging with 650 KOL treating autoimmune myositis, advancing disease state education, engaging patient communities, and getting ready to expand our field force footprint. With that, let me turn the call back to Karen for closing remarks.
Thank you, Sandrine. As you heard today, we continue to see strong momentum across the business, with significant opportunities ahead for VYVGART and a pipeline positioned to sustain growth well into the future. While there is much to be proud of in the first half of the year, there is even more ahead. We enter the second half of 2026 with multiple opportunities to advance innovation and further our mission of transforming the lives of people living with autoimmune disease. I want to thank our team, patients, and strategic partners for their continued commitment as we continue this mission together. With that, operator, we'll open the call for questions.
If you would like to ask a question, please press star five on your telephone keypad. You may remove yourself at any time by pressing star five again. We would like to remind callers to please limit to one question. We'll pause just a moment. Our first question will come from Myles Minter. Your line is now open. Please go ahead.
Thanks very much. Congrats on the quarter. Looking forward to the myositis data in the third quarter here as well. I'll keep it to one on the commercial business. You've delivered quarter-over-quarter sort of mid-teens % growth if you take out the first quarter seasonality. I just had a question on whether that sort of future growth trajectory might change with the launch in the seronegative population here, whether there's any sort of tailwinds that we should think about from the broader population now that most plans are not requiring the serology testing for that population. Thanks very much.
Thanks for the question, Myles. I would agree with you. It is incredible, 18 quarters in, that we're still delivering consistent growth quarter-over-quarter. What I would say related to the quarterly trends, of course, every quarter has its own dynamics. After Q1 seasonality, we generally see some rebound in Q2, but we expect the shape of the curve for the remainder of the year to look pretty consistent to what you've seen it in prior years. We're off to a strong start, of course, with seronegative. We've had the same dynamic in prior years with the launch of the PFS and that type of thing. I would expect it to continue to look to grow and to look similar to prior years. Thanks for the question, Myles.
Our next question will come from Derek Archila with Wells Fargo.
Hey, good morning. Congrats on the quarter here. Excellent results. I just wanted to understand, where do things stand with the ocular MG filing? I guess, maybe going to more tailwinds, assuming approval, I guess how do you think Ocular could be a growth driver, does that really materially change VYVGART's revenue trajectory? Thanks.
Yeah, thanks for the question. We're moving forward with urgency on Ocular MG filing. There's a big patient unmet need in Ocular MG. Of course, there's no advanced therapies approved in this patient population. We will be the first and only approved treatment in this population. We'll update you when we have a PDUFA date. Maybe, Sandrine, you could comment a little bit on how you see the outlook if we do have an ocular approval.
Thanks, Karen, and Derek for the question. I see the Ocular MG potential approval as another way to continue and to support our growth momentum. Over the last five years, we basically have had five launches when you think about that. This would give us another launch to continue that growth momentum. We're well-positioned because many of these patients are being treated by neurologists, and this is already a population of providers that we visit and that have experience with the drug. I'm very confident that this will be adding another leg to our growth for the long term.
Our next question will come from Tazeen Ahmad with BofA.
Hi. Good morning. Thanks for taking my question. Karen, and maybe Sandrine, I wanted to get your thoughts about the competitive landscape. You're right, your 18 quarter is in and you've had commanding share. There continue to be new launches and upcoming launches, and some of the competitors that are talking about what advantages their products might have include comments such as efficacy may not necessarily be where it needs to be with FcRns in general, and that patients might be dropping off therapy due to safety observations. Can you maybe share with us your feedback from the field about what doctors' satisfaction is vis-a-vis their patient commentary on both efficacy, and can you talk to us about dropouts as a result of any safety concerns? Thanks.
Yeah. Thank you, Tazeen, for the question. Let me just comment broadly on competition, then I'll hand it over to Sandrine. We've had this question a lot. I would say we launched in MG, and I like to say that argenx put MG on the map, and there's been a lot of competition that has followed us into the space. Throughout that, we've maintained our leadership in the market. You can see, for example, four out of five physicians continue to say that they choose VYVGART before any other biologic. Sandrine, maybe you want to comment on specifically the efficacy advantage and any other dynamics you see in the market.
Yes. VYVGART, like you said, Karen, is being seen and is being used today earlier than the others. The others are used more in refractory populations, and it's being used in earlier lines. The reason is that the label supports it and the data support it. When you look at the data, I wonder if anybody else can demonstrate an MSE that we have. We have 60% of patients that have reached minimal symptom expression, and then that MSE is sustained over time. I haven't seen, until now, other competitors being able to demonstrate MSE or even speak about MSE. That's really what stands out when you speak about the efficacy of VYVGART.
If you combine that with its safety over more than 25,000 patient years, this is a very strong combination of safety and efficacy profiles that puts us in a position to be used earlier lines. That's why, until now, we haven't really seen a meaningful impact on our growth trajectory.
Our next question will come from Alex Thompson with Stifel.
Great. Thanks for taking our question. For Karen, could you walk us through sort of what we should expect to see now at the top line for myositis in terms of both primary endpoint clinical data as well as the potential path to filing, particularly in DM? Thanks.
Thanks, Alex. We're really looking forward to the readout in Q3, and we're on track. Just to set the stage, what we see as success for myositis is positive readout on the primary endpoint in one or more subsets. That's the data that we'll share. You'll remember from our myositis day that we shared that we see both of these indications on their own as potential blockbuster indications. They both have significant unmet need, and they're both actually strategically important to us. If we proceed with an approval, this will be important because it'll be the first-in-class FcRn approval in rheumatology. We'll be looking for positive data on the primary endpoint in one or more subsets. Beth, you want to share a little bit more about what they can expect to see at top-line results?
We're still working out the specific details of what the communication will look like. What we know is that this is an important event with positive data for argenx. It's our entry into rheumatology, and we'll want to capture that in our communication, and we'll also want to capture the primary endpoint analysis in IMNM and in DM. The details are still to come, but you can assume that those are the key topics of the communication.
Our next question will come from Akash Tewari with Jefferies.
Thanks so much. Can you give a little more color on your stat plan for myositis? Based on your public comments, it seems like there is no alpha split. DM and IMNM are now being run independently as two separate trials. Is that the correct read here? If the effect size in DM for your phase II trials was replicated in phase III, would the trial hit stat sig or not? If not, what are some reasons that efficacy could improve from phase II to phase III? Thank you.
Thanks for the questions, Akash. We have Luc here, so I'll ask him to comment.
Thanks, Akash. You are correct. The way we now approach the analysis of the phase III is that we will independently analyze the subset, so each has their own chance to win. As you also know from the research day, of course, the enrollment differed between subsets, so that will affect the intrinsic power. Nevertheless, the analysis plans are completely in parallel. With respect to your question on effect size, if we see effect size in phase III, in the end, that will be observed in phase II. You could make the assumption that because it's twice as long and twice as big, that that would increase the chance for a statistics difference, which is certainly true, but not a guarantee. We just still have to turn the data cards, see what we have, and then determine our path forward.
Whether stat sig or stat negative, we are working on a plan forward in the end.
Our next question will come from Rajan Sharma with Goldman Sachs.
Hi. Thanks for taking my question. I've actually got one on empasiprubart. Could you just provide a little more color on the DGF update, please? It seems like you're progressing development, but not in DGF itself. Can you maybe help us understand what the forward path is here in terms of indications and when you may be in a position to move to a pivotal trial and what it was that you saw in the 52-week data that gives you confidence to move forward? I'm just wondering if there's any additional reassurance into MMN based on what you've seen in the DGF trial. Thank you.
Yeah. Happy to have Luc comment on this. Just a reminder, this was a phase II proof of concept study. What we wanted to do was use it to explore and learn about the use of empa in the transplant setting broadly, with a focus on DGF in the particular study. Luc, maybe you can talk about what we saw and the path forward.
Yeah. Thanks, Karen. Thanks for the question. As already said, this was a relatively small trial, basically evaluating a hypothesis whether we could influence reperfusion injury with this mechanism. The transplant situation lends itself to this. We had chosen as a target DGF, which is a relatively short-term goal. When we saw the data at 24 weeks, we found an intriguing signal, which made us decide, let's continue the exploration of the study up to 52 weeks, which more or less confirmed that there is something in the renal parameters here that is affected, which gives us an interesting perspective on exploring the transplant. However, it does not support DGF, which, as I said, is a short-term readout to be continued as an indication.
Maybe just to comment on the second part of your question around MMN read-through. I don't think I would take any read-through for MMN other than we did see some effect of the drug. In particular for MMN with the readout in Q4, I think the most important data point to look at there was our positive phase II study, where on the endpoint of grip strength, both in the initial phase Part A as well as the open label extension, we saw positive results. Thanks for the question.
Our next question will come from Yatin Suneja with Guggenheim.
Hey, guys. Thank you for taking my question. Again, excellent results, congrats again. Quick one on the pipeline, specifically on ARGX-121, the IgAN program. Could you maybe talk a little bit about the profile that you have seen in phase I that is enabling you to move into phase II? What level of IgA reduction you saw, how should we think about frequency, all of that? Thank you.
Thanks for the question about ARGX-121. We're really excited about ARGX-121 and broadening our pipeline with the IgA sweeper. We had shared data specifically from phase I and with the profile that showed that ARGX-121 reduces IgA by about 90% within a matter of days, and that reduction is maintained all the way out till day 28 with one single dose. Very impressive data, and we're moving very quickly with urgency into IgAN. Perhaps, Luc, you could share your thoughts on the IgAN program, clinical development program.
With such a signal in phase I, we are very excited to keep this really moving fast. When we showed those data to key opinion leaders, they were also very enthusiastic, and this speed and depth really puts it aside from, as we all know, IgAN has quite some efforts going on, but our signature of the drug here really set us apart and is really offering us great hopes for the phase II and the phase III that we can bring a meaningful drug to patients.
Our next question will come from Yaron Werber with Cowen.
Great. Thanks so much. Congrats on a really nice quarter. Just a question for you on MMN, and thanks for putting that slide into the deck that shows the grip strength change from baseline. What we hear from clinicians is that eight points is clinically meaningful, and I believe the primary is non-inferiority, and then you have superiority. Can you maybe just talk about that phase III trial design, maybe a little bit of the powering or whatever you can share as to what do you expect from baseline? Thank you.
Maybe Luc has a particular view. Talk about the study design.
Thanks for the question because it allows us to talk to what are we really trying to achieve at argenx. With the phase II data, as you remember, we had an 81% reduction in the need for rescue with IVIG for those that received empasiprubart. To the point where we said, if every rescue we need to take forward is on IVIG, we might as well do IVIG head-to-head, which would also provide the most meaningful data for prescribers. We designed this trial where, after stabilization on IVIG and optimizing, that we initiate either a continuation of the IVIG regimen or a switch to empasiprubart. The endpoint here is indeed grip strength, which we picked in conversation with the agencies because there were quite meaningful data available, which allowed us to define a non-inferiority margin.
The non-inferiority margin is set, pretty relevantly, but we also have the opportunity to go to superiority. Based on the phase II data, and what we learned on IVIG, that there is, in my opinion, a great chance that we could show that, but the non-inferiority at least gives us the ability to at least provide the best information.
Thanks, Luc. Just to wrap it up, what I would say is what we see as success is a positive readout on the primary endpoint, non-inferiority, and obviously upside would be superiority. When we speak to KOLs and prescribers, we certainly hear excitement about the fact that we have a head-to-head versus IVIG. Certainly with our experience in CIDP, we have some experience competing in that space as well. I think we're set up for success, assuming a positive readout towards the end of the year with MMN.
Our next question will come from Danielle Brill with Truist.
Hey, guys. This is Alex on for Danielle. Thanks for the question and congrats on the quarter. Just a question on CIDP as it pertains to the current commercial dynamics as well as the ongoing EMPA trials. As far as it relates to the commercial read-through of the CIDP launch, in the regions where VYVGART is available, who are the types of patients who are enrolling in the EMPA CIDP trials instead of trialing VYVGART? Thanks.
Hi. Yeah. Maybe to start, just to lay out our strategy with CIDP. We see that CIDP is a heterogeneous disease and there is significant unmet need. Until VYVGART launched, there hadn't been innovation in the space for 30 years, and we've seen the strong uptake of VYVGART in CIDP. What we know is with the disease heterogeneity, that there is also IgM driving the disease, and so that's why we have the study with empasiprubart where we think we have strong biology rationale. Our hypothesis is that there are some patients. We have a 70% response rate with VYVGART. Those patients that don't respond to VYVGART might have more IgM-driven disease, and so we think that there's an opportunity for empasiprubart in those patients.
There also might be patients where they have sort of multiple drivers of the disease, and so an overlap that might be eligible for both VYVGART and empasiprubart. Our strategy here is to study empasiprubart, and we're enrolling empasiprubart in a broad patient population so we can understand the impact of empasiprubart on the disease. Once we have the data readout, we can analyze that data as well as the VYVGART data and really understand what is driving the best outcome for patients and move forward with a commercial strategy from there. Thanks for the question.
Our next question will come from Thomas Smith with Leerink Partners.
Hey, guys. Good morning. Thanks for taking our questions, let me add my congrats on the really strong quarter here. On the pipeline, could you just provide some updated thoughts on how you're thinking about advancement between your next-gen FcRn candidates ARGX-213 and ARGX-124? Any additional color on the target profile you're aiming for with ARGX-124 with respect to IgG lowering or dosing interval or other potential differentiation? How do you think about indication selection between life cycle management and potential expansion opportunities across those candidates? Thanks so much.
Yeah. Thanks for the question. Our goal with FcRn is to maintain our leadership and even advance our leadership for decades to come, and we have a few pieces or parts to that strategy. Our next-generation molecules, 213 and 124 that you referred to, 213 is we call it phase III-ready, and 124, we're in phase I at the moment, and by the end of the year, we'll be in a position to move it into late-stage clinical development. At the moment, we're working with our teams based on that data to assess the two molecules. Of course, Argenx-213 we know has a Q4W dosing schedule.
Argenx-124, we're further categorizing the advantages that it will bring over VYVGART at the moment, and then we'll be in a position where we can lay out what the strategy is for the full portfolio between VYVGART, 213 and 124. The other component of our strategy that's really exciting is that we are in development of an oral FcRn, and that program also moves forward quickly at the moment. Thanks for the question.
Our next question will come from Sean Laaman with Morgan Stanley.
Good morning, Karen and team. Hope everyone's well. Karen, just going back to the seronegative gMG impact. What specifically prescribing trends have most exceeded your expectations, and how should investors think about the revenue contribution from seronegative patients over the next 12-24 months?
Thanks for the question. I'll hand it over to Sandrine in a moment, but I'd be remiss if I didn't just say, first of all, that I'm really proud to see seronegative launch. It really is the argenx playbook in action. We made a commitment to this patient population many years ago when we launched VYVGART, that we would bring this innovation to seronegative patients. To see that happening in the market and being so positively responded to is really exciting. Sandrine, maybe you could comment a little bit more on the dynamics you're seeing with the launch.
Thank you, Karen, and thank you for asking a question on seronegative, because for me, this is a big event in the second quarter, so it's great to have someone asking that question. I spent time in the field over the last few weeks to listen directly and hear the feedback from prescribers, but also from patients. Although we are only 10 weeks in, so it's still very early, the feedback is overwhelmingly positive. You saw the quotes I had in the presentation from the patients. Many were actually waiting for solutions because they had been excluded from clinical trials, especially the triple seronegative patients, and they were really waiting for an option. A lot of hope, a lot of enthusiasm for the patient side. Some of them were calling the physician to make sure that they had access to the product as soon as possible.
On the provider side, what is interesting is that when you look at what the provider are saying is that they consider now that the fact that we add seronegative to the label is that we now have a fully loaded gMG label, and that adds simplicity in decision-making, streamlining decision-making. They quote, "I consider now VYVGART as the go-to option for all my gMG." One of the things we have observed over the first few weeks is that it has really a strong halo effect beyond the seronegative patients onto the positive serotype patient, and that was something that we were expecting, but it's great to see confirmed.
What we are also very happy about is that the payers have been approving quite quickly and endorsing their policy VYVGART in seronegative, where we have roughly 55% of the covered lives yet already less than three months after launch. I had said that it would take three to six months to get to roughly 90%, and we are well on track to get there. What is also very important is not just the quantity of coverage, but also the quality. Seeing that the majority of the plans are removing the testing requirements for the serotype is also making the life of the providers easy. If I would summarize, it's all about leadership in MG with that approval, but also simplicity of decision-making for the providers. Great feedback until now.
Thank you.
Our next question will come from Samantha Semenkow with Citi.
Hi, good morning, and thanks very much for taking the question. Just one on CIDP for me. You outlined in your slides market expansion opportunity. I'm wondering what you're seeing in the data about treatment-naive patients utilizing VYVGART as a first-line. Are you seeing a shift towards these patients being treated more frequently? If so, how should we think about the progression of the launch in that segment going forward? Thanks very much.
Thanks for the CIDP question. Sandrine, maybe you can comment.
It's indeed a very big opportunity for us to really make sure that VYVGART is used as early as possible because still the majority of the patients start with IVIG when they start a treatment for CIDP. We publish data, and we are generating more and more evidence to show that if you are prescribing VYVGART for treatment-naive patients, actually you see clinical benefits. We presented a study at AAN where we show that 87.5% of the patients that were treatment-naive benefited from a clinical response. We are using data to encourage physicians to try VYVGART in earlier line patients, and they are seeing good results. It's taking time.
It's taking time because you have to change entrenched habits, and you have also to make sure that payers are supporting that, because still the majority of them are requiring some kind of experience with IVIG. That's what we are working on. You see more and more traction in the treatment-naive population as well as in the patients that are seen as well managed but need some more functional improvement.
Our next question will come from Gavin Clark-Gartner with Evercore ISI.
Hey, thanks for taking the question. Just following the recent ralipracimat update, are you considering any changes to your CIDP development plans for EMPA? I guess on this point, did this outcome change what you think the likelihood of EMPA meeting superiority versus IVIG is in either CIDP or MMN? Thank you.
Yeah. Thanks for the question, Gavin. As a reminder, before I hand it over to Luc, our clinical development program for CIDP for empasiprubart has two studies. One is the head-to-head versus IVIG, and the other is a placebo-controlled study. I think it's around the placebo-controlled study that you're particularly asking for, but also maybe some comments, Luc, on your confidence in the IVIG study as well.
Yeah. What is important to realize, CIDP, we used the term already, is a heterogeneous disease also. Therefore, your selection of patients matters. We took particular care in that HERE study to install, for example, that clinical education committee, which now has become the standard. We continue to exclude possible CIDP patients, for example, as one of the differences. If you then on top of that, go with very refractory patients, you may come in a situation where the disease has burned out more or less. What's your ability to change? We, of course, want to learn, we will be looking more closely at these data and evaluate is there anything we need to do to optimize our studies, we are continuing with our plans to continue both.
Yeah. Maybe just one more comment on that has made me reflect on is that it's very clear from this that it's not easy to run successful clinical trials in CIDP. One advantage that we have is that we do have the VYVGART experience, and we've been able to demonstrate that ability. That gives me additional confidence as well.
Our next question will come from Sophia Graeff with JPMorgan.
Good afternoon. Thanks for taking my question. One on the upcoming myositis trial. You commented that you currently no longer see a path forward for polymyositis patients. Given the strong evidence that ASIS is autoantibody driven, would there be scope to run an ASIS specific trial in future or is this population still a bit too small to target?
Thank you for that question. We, of course, want to reach as many patients as we can. Just from a technical point of view in this trial with the enrollment numbers, we just can't get there, but we will learn. ASIS is not just confined to PM, and polymyositis itself is heterogeneous and has been a bit kind of being more and more allocated to the other subsets as we get to know more. We will definitely look at the data as they come and determine a path forward for ASIS.
Thank you.
Our next question will come from Victor Floch with BNPP.
Hey, thanks so much for taking our question. Maybe just one on the PFS. I've noticed in your slide that the proportion of PFS patients new to VYVGART actually increased to 80% from 68% in Q1, which is quite impressive. I was just wondering whether it makes you incrementally more bullish about the auto-injector opportunity and whether there's any chance you can share more details on the remaining development milestone for the auto-injector and the expected launch timing. Thank you very much.
Yeah. Thanks for the question on PFS. I'll hand over to Sandrine in a moment. Just to confirm, auto-injector is on target or on schedule for 2027 launch. Maybe some of the dynamics you're seeing with prefilled syringe in the market, Sandrine.
Yeah. Thank you for your question, Victor. Indeed, I wrote on the slide 80% of the patients that are on PFS in the second quarter in the U.S. are new to VYVGART. It's true expansion for us. You compare to last time where we said 68%. Last time, 68% was launched today. These were the patients since the launch. This time, we should actually just for Q2. If you look at launch to date, to compare apples with apples, we would be at 70%. It's a slight increase, but it's not 80%. 80% is really the last quarter, and it shows that actually more and more of the patients that start on VYVGART actually are truly new or start on PFS, sorry, are new to VYVGART. Thank you for the question.
Our next question will come from Andy Chen with Wolfe.
Hi, thank you for taking my question. This is Jason taking it for Andy. I just wanted to ask a question in terms of seronegative approval and what its effect on this quarter's earnings has. Also, I wanted to ask in terms of the launch curve of seronegative and ocular, will they be similar or what might there be in terms of subtle differences and anything to think about when we're looking at the uptake of ocular? Thank you.
Yes, thanks for the question. Karl, maybe you can comment on the dynamics of the quarter.
Thank you, Karen, and thank you Jason for the question. Sandrine already mentioned in the prepared remarks, the quarter was driven by strong fundamentals and PFS was the key driver of growth. However, seronegative of course, is also a contributor, in particular, the triple negative patients where we see the huge unmet need, and also the halo effect the seronegative had on the broader gMG market. Of course, we expect that to also flow into Q3. In terms of ocular, I think as we always said, you need continued innovation to maintain the growth. Regular new launches, of course, is what we need, and I think we are very excited that we're going to continue to deliver that for patients. Thank you for the question.
Your next question will come from Luca Issi with RBC Capital Markets.
Oh, great. Thanks so much for taking the question, and congrats on another great quarter. Maybe Luc, just want to circle back on a prior question. Myositis, you mentioned that IMNM and DM are independent analyses. Each of them has its own chance to hit the stats. Did the FDA still ask you to split the alpha between the two trials, given that this was originally structured as an all-comer trial that enrolled both populations together? Are each trial at this point completely independent from one another, and there's absolutely no crosstalk between the two trials? I guess the other way to ask the question, are these trials successful if the P value is below 0.05?
Do you need to hit P value below 0.025? Again, you're splitting the alpha between the two trials. Any color there much appreciated. Thank you.
Yeah. I want to stay consistent with how we answered that at the R&D day, which is we're not going to comment on a specific alpha value. Even in these rare diseases, even with alphas that are in between 0.05 and 0.1 even, you can have a conversation. It's not that we can go in there, but I'm just saying we're not going to disclose the actual alpha value. Yeah, the data card is to be turned soon.
Yeah. Maybe just to give you some additional insight and color on the strategy and the filing strategy. As Luc shared earlier, the analysis plan is independent of each other. IMNM and then DM separately. They are two separate analysis plans. Our filing strategy and path forward is in IMNM. Recall that there are no approved treatments in IMNM, we have breakthrough designation with the FDA and have had those communications based on that with the FDA. In DM, what we will be looking for, of course, is statistical significance, and once we have that data, we will be able to continue discussions with the FDA on what the path forward is there.
What I want to come back to is that with this myositis study, what we have given ourselves the opportunity to do is have two opportunities for label expansion, both or each of them individually as potential blockbuster indication, IMNM and DM. We are on track for Q3. We will turn the data card, and we will determine the path forward from there.
Got it. Thanks so much.
Our next question will come from Sebastiaan van de Sype with Kempen.
Hi, guys. Congrats on the excellent quarter, and thanks for taking the question. Can you maybe share your latest thinking on your ambitions regarding business development and M&A? What should or should we not expect in this aspect for the next 12-24 months? Can you maybe describe the profile of assets that you'll be looking for to add to your pipeline? Thank you.
Yeah. Thanks for the question. Our overall capital allocation strategy is very much focused on delivering growth, both in the short, mid, and long term. In line with that, our capital allocation strategy focuses on, number one, fueling VYVGART growth, number two, funding and accelerating our internal pipeline. That includes our FCRN assets that I was talking about earlier, but also beyond FCRN. Then, of course, with the strength of our balance sheet, we also have the opportunity to look at business development. Now, looking at business development opportunities in order to identify potential new assets is not a new strategy for us. In all ways, the approach that argenx has taken has been to partner to look for novel biology, new mechanisms of action, where there's significant unmet patient need.
In the past, we partnered with academic institutions in order to identify that biology and build those molecules. With the strength of our balance sheet, and our continued profitability, we can now widen the lens and also look at biotech companies that are pursuing, but we use the same bar for those business development opportunities as we do for our internal pipeline. That bar is that it has to be novel biology, and it has to be in areas where there is significant unmet patient need. We hold the bar high, but I can tell you when we find those opportunities where we can have an impact for patients, we will leverage the flexibility of the balance sheet to be able to go after them and continue to build our pipeline. Thanks for the question.
Our next question will come from Douglas Tsao with H.C. Wainwright.
Hi, good morning. Thanks for taking the questions. I'm curious in terms of the CIDP opportunity and the slide where you indicate the number of patients who are diagnosed but not treated. I'm just curious if your sense is, if those patients aren't being treated, just given the sort of tolerability issues related to IVIG, and is VYVGART's sort of tolerability become an attractive sort of attribute that you are going to sort of try to sell to clinicians in terms of bringing those patients back into treatment?
Yeah. Thanks for the question, Douglas. I think what you can see from that slide that I find exciting is that it's clear we're just at the beginning of the growth curve for CIDP, and there's a lot of opportunity for continued growth. Maybe, Sandrine, you can share what you're seeing in the market around those patients.
Yes. Thank you, Karen. Indeed, CIDP, lots of opportunities for further growth within the addressable market we started with at launch, but also way beyond that. What I noticed when I discussed CIDP with patients, but most importantly with providers, is that it's a disease which is not well understood and where there is not really a true dialogue between the patients and the providers, where actually the unmet need is underestimated. Even when a patient is being treated and is thought as being well-managed, actually, this is not the case because there is not this true dialogue. I often use the example like, you would ask somebody, "Are you doing okay?
Can you brush your hair in the morning?" The person say, "Yes, I can." Then when you ask how they will do that, they say, "I'm lying on my bed to brush my hair," which shows that there is really a muscle weakness there and that we must show to this patient and this provider that you can make a difference by putting them on treatment like VYVGART.
This is the same happening for patients who are not on treatment, and that have been diagnosed because they underestimate their level of how they function every day. They have accommodated their life. They have moved from a house to an apartment. They don't drive anymore. They have just lowered the bar of what their life should look like, what their quality of life should look like. What we're trying to do is generate data to show that you can get your life back if you really take that seriously. This takes time, this takes a lot of data generation, and it takes also patience to go and have the discussion with their providers. That's what we are trying to do.
Our next question will come from Qize Ding with Redburn.
Hi, thanks for taking my question. Can I just ask a quick follow-up question on the BD? Are you interested in the assets within the same therapy areas that could further strengthen your existing portfolio? Or are you looking for complementary assets that could broaden your portfolio? Thank you so much.
Yeah. Thanks for the question. When we build our pipeline, whether it's with internal assets or through business development, we're focused on immunology assets, but we are focused on diversifying our pipeline beyond FCRN. You can see that within our internal pipeline. Of course, we have empasiprubart, we have ARGX-121. We also have molecules in earlier stage development that are very exciting. When we look at internal and external molecules, we set the bar as what we're looking for is novel biology, and we need to have clarity on how we can de-risk that novel biology to move into patients. We keep the bar high on that, as well as these areas of high unmet patient need, where we could be bringing the first-in-class or the best-in-class assets forward for patients.
That's the strategy that we have for both our internal pipeline as well as business development.
Our next question will come from Xian Deng with UBS.
Hi, thank you for taking my question. One on DM, please. Just wondering, there are some studies or evidence suggesting DM is more sort of interferon 1-driven disease, and the role of autoantibodies is not as clear as that in IMNM. Just wondering for your DM study, but I think on the other hand, especially in DM, some autoantibodies have very strong predictive power to prognosis and symptoms, et cetera. Just wondering, do you see some several subtypes of DM that potentially have better response and are you enriching those for the study? Thank you.
Yeah, thanks for the question. Maybe I can just start by sharing at a high level what we shared at R&D Day, which is we see a clear biology rationale for both IMNM and DM. They are both autoantibody-driven diseases. Maybe Luc, you can provide a little more detail.
Yeah. Again, the theme of these diseases are not driven by just one mechanism, which is why we thought that multiple modes of action are moving forward. The DM is more clearly is more in the Interferon one pathway, as you indicate, which we feel is clearly a demonstrated driver, mostly in skin pathophysiology, but some in the muscle. We feel that given the demonstrated level of autoantibodies presence in these diseases and their targets, that addressing primarily the autoantibodies has a role to play. In that sense, our Phase II subsid data demonstrate that there was a signal in DM, which could not be driven by Interferon one. Yeah, there's place for more than one approach here.
Yes. That was what I was going to just close out with. I think that's important, Luc. There's been really very limited innovation in the myositis space for many, many years. I think if you zoom out, there is room for more than one mechanism of action in DM. In particular, what I think is going to be important, is to look at the muscle involvement and the impact of these mechanisms of action on the muscle, because that is the defining feature of this disease, and that's something that we'll be looking for in our Phase III readout. Thanks for the question.
Our final question will come from Niall Alexander with Deutsche Bank.
Hi, good afternoon. It's Niall Alexander from Deutsche Bank. Thanks for taking my questions. Just one on VYVGART pricing and channel mix. It'd be helpful seeing if you can provide the actual realized list price per average subcutaneous patient at present. Any color you can give on gross to net pricing and discount. In addition, it'd be great to get a sense of the channel split for VYVGART sales right now. Thank you.
Thank you. Yeah, of course. The list prices in the U.S. is public information, and you can also reach out to us if you need help with it. I think what is important is that the gross to net and the net price per patients have continued to be stable. It's the same in Q2 as it was in prior quarters. Over time, you'll see a slight increase in gross to net quarter-over-quarter, and that is because PFS, prefilled syringe for self-injection, do have a slightly higher gross to net than the other presentations, but that of course, is offset by higher adherence. I think what we can say is that the net prices per patient continues to be stable, and there's nothing really new to say. Thank you for the question.
There are no further questions. This concludes our conference for today. Thank you for participating. You may now disconnect.
Investor releaseQuarter not tagged2026-07-16argenx to Report Half Year 2026 Financial Results and Second Quarter Business Update on July 23, 2026
GlobeNewswire
argenx to Report Half Year 2026 Financial Results and Second Quarter Business Update on July 23, 2026
July 16, 2026Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, July 23, 2026 at 2:30 p.m. CET (8:30 a.m. ET) to discuss its half year 2026 financial results and provide a second quarter business update. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation. Participants can access the conference call by dialing 800-590-8290 (United States and Canada) or 240-690-8800 (International). Country specific dial-in numbers are listed below: Belgium 32 2290 4635France 33 172 001717Netherlands 31 20 795 2683United Kingdom 44 203 393 1560Japan 81 3 4520 9761Switzerland 41 43 210 51 68 Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call. About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube. Contacts Media: Ben [email protected] Investors: Alexandra [email protected]
Investor releaseQuarter not tagged2026-05-12Halozyme's Q1 Earnings & Revenues Beat Estimates, Stock Up
Zacks
Halozyme's Q1 Earnings & Revenues Beat Estimates, Stock Up
Halozyme Therapeutics HALO reported first-quarter 2026 adjusted earnings of $1.60 per share, which beat the Zacks Consensus Estimate of $1.54. Earnings rose 44.1% year over year. Total revenues in the first quarter increased 42% year over year to $376.7 million. Revenues too surpassed the Zacks Consensus Estimate of $358 million. The top-line growth was primarily driven by an increase in product sales as well as higher royalty payments. HALO received royalty payments from Roche RHHBY for Phesgo and J&J JNJ for subcutaneous Darzalex (daratumumab), as well as argenx ARGX for Vyvgart Hytrulo. Several companies use HALO’s Enhanze technology to develop a subcutaneous formulation of their currently marketed drugs. Halozyme now has several marketed partnered drugs based on this technology, including the subcutaneous (SC) formulation of J&J’s Darzalex, Roche’s Phesgo and argenx’s Vyvgart Hytrulo. Shares of Halozyme were up 3.6% in after-hours trading on Monday owing to the better-than-expected results. However, the stock has lost 1.3% year to date compared with the industry’s 2.6% decline. Image Source: Zacks Investment Research Halozyme’s top line comprises product sales, royalties and revenues under collaborative agreements. Royalty revenues totaled $240.7 million in the first quarter, up 43% from the year-ago quarter’s level. This was mainly due to the robust demand for RHHBY's Phesgo, JNJ's subcutaneous Darzalex and ARGX's Vyvgart Hytrulo, on which it earns royalties. Royalty revenues, however, missed our model estimate of $256.6 million. Product sales were $130.4 million in the first quarter, up 67.2% from the year-ago quarter’s level. HALO has two commercial proprietary products, Hylenex and Xyosted, with the latter acquired from Antares Pharma in 2022. Product sales beat our model estimate of $91.1 million. Revenues under collaborative agreements were $5.6 million in the reported quarter, down almost 70% year over year. Adjusted EBITDA was $229.5 million in the reported quarter, compared with $162 million in the year-ago quarter. Halozyme had cash, cash equivalents and marketable securities of $320.9 million as of March 31, 2026, compared with $145.4 million as of Dec. 31, 2025. Halozyme reiterated its total revenue guidance for 2026, which it had provided earlier this year. The company continues to expect total revenues in the range of $1.71 billion to $1.81…Read full documentShow less
Halozyme Therapeutics HALO reported first-quarter 2026 adjusted earnings of $1.60 per share, which beat the Zacks Consensus Estimate of $1.54. Earnings rose 44.1% year over year. Total revenues in the first quarter increased 42% year over year to $376.7 million. Revenues too surpassed the Zacks Consensus Estimate of $358 million. The top-line growth was primarily driven by an increase in product sales as well as higher royalty payments. HALO received royalty payments from Roche RHHBY for Phesgo and J&J JNJ for subcutaneous Darzalex (daratumumab), as well as argenx ARGX for Vyvgart Hytrulo. Several companies use HALO’s Enhanze technology to develop a subcutaneous formulation of their currently marketed drugs. Halozyme now has several marketed partnered drugs based on this technology, including the subcutaneous (SC) formulation of J&J’s Darzalex, Roche’s Phesgo and argenx’s Vyvgart Hytrulo. Shares of Halozyme were up 3.6% in after-hours trading on Monday owing to the better-than-expected results. However, the stock has lost 1.3% year to date compared with the industry’s 2.6% decline. Image Source: Zacks Investment Research Halozyme’s top line comprises product sales, royalties and revenues under collaborative agreements. Royalty revenues totaled $240.7 million in the first quarter, up 43% from the year-ago quarter’s level. This was mainly due to the robust demand for RHHBY's Phesgo, JNJ's subcutaneous Darzalex and ARGX's Vyvgart Hytrulo, on which it earns royalties. Royalty revenues, however, missed our model estimate of $256.6 million. Product sales were $130.4 million in the first quarter, up 67.2% from the year-ago quarter’s level. HALO has two commercial proprietary products, Hylenex and Xyosted, with the latter acquired from Antares Pharma in 2022. Product sales beat our model estimate of $91.1 million. Revenues under collaborative agreements were $5.6 million in the reported quarter, down almost 70% year over year. Adjusted EBITDA was $229.5 million in the reported quarter, compared with $162 million in the year-ago quarter. Halozyme had cash, cash equivalents and marketable securities of $320.9 million as of March 31, 2026, compared with $145.4 million as of Dec. 31, 2025. Halozyme reiterated its total revenue guidance for 2026, which it had provided earlier this year. The company continues to expect total revenues in the range of $1.71 billion to $1.81 billion for 2026, implying year-over-year growth of 22% to 30%. Total revenues are expected to grow due to increased royalty revenues and higher product sales from API. Royalty revenues are anticipated in the range of $1.13-$1.17 billion, implying year-over-year growth of 30% to 35%. Adjusted EBITDA is expected in the band of $1.13-$1.21 billion, implying a year-over-year surge of 71% to 83%. Adjusted earnings are expected in the range of $7.75-$8.25 per share in 2026, implying growth of 87% to 99% year over year. HALO’s adjusted earnings per share guidance included the impact of approximately $60 million related to the recent Hypercon and Surf Bio investment. The adjusted earnings per share guidance does not consider the impact of potential future share repurchases. Halozyme Therapeutics, Inc. price-consensus-eps-surprise-chart | Halozyme Therapeutics, Inc. Quote Halozyme currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report argenex SE (ARGX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-05-12AbCellera Biologics Q1 Earnings Call Highlights
MarketBeat
AbCellera Biologics Q1 Earnings Call Highlights
Interested in AbCellera Biologics Inc.? Here are five stocks we like better. AbCellera’s lead program ABCL635 advanced with interim Phase 1 data showing it was generally well-tolerated, with no serious adverse events or liver toxicity, and the company said it remains on track for Phase 2 top-line data in Q3 2026. The company highlighted target-engagement evidence for ABCL635, including sustained, dose-dependent testosterone suppression, which management said supports the idea that the antibody can reach its intended NK3R target in the hypothalamus. AbCellera ended Q1 with about CAD 655 million in available liquidity including government funding, while narrowing its quarterly net loss slightly year over year as it continues to shift resources toward its internal pipeline. Argenx's 28% Surge & Promising Product Propel Investor Confidence AbCellera Biologics (NASDAQ:ABCL) said its first quarter of 2026 was marked by progress in its internal drug pipeline, including interim Phase 1 data for its lead program, ABCL635, and continued preparation for multiple clinical catalysts expected over the next two years. President and CEO Dr. Carl Hansen said the company entered 2026 in a “strong financial position,” with major platform and infrastructure projects “substantially complete” and its internal pipeline positioned for several upcoming readouts. The company’s priorities for the year include top-line data for ABCL635 and ABCL575, advancing ABCL688 and ABCL386 through IND-enabling activities, and adding at least one new development candidate. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum The most closely watched milestone is the Phase 2 readout for ABCL635, which Hansen said remains expected in the third quarter of 2026. The program is being developed as a potential first-in-class antibody medicine for the non-hormonal treatment of moderate to severe vasomotor symptoms, or hot flashes, associated with menopause. Chief Medical Officer Dr. Sarah Noonberg presented interim Phase 1 data for ABCL635, an antibody targeting NK3R, a GPCR target that has been clinically validated in hot flashes. The Phase 1 trial was a randomized, double-blind, placebo-controlled study in healthy volunteers, including a single ascending dose portion and a multiple ascending dose portion. → 3 Ways to Target the Resources Powering AI and Data Centers Noonberg said unblinded da…Read full documentShow less
Interested in AbCellera Biologics Inc.? Here are five stocks we like better. AbCellera’s lead program ABCL635 advanced with interim Phase 1 data showing it was generally well-tolerated, with no serious adverse events or liver toxicity, and the company said it remains on track for Phase 2 top-line data in Q3 2026. The company highlighted target-engagement evidence for ABCL635, including sustained, dose-dependent testosterone suppression, which management said supports the idea that the antibody can reach its intended NK3R target in the hypothalamus. AbCellera ended Q1 with about CAD 655 million in available liquidity including government funding, while narrowing its quarterly net loss slightly year over year as it continues to shift resources toward its internal pipeline. Argenx's 28% Surge & Promising Product Propel Investor Confidence AbCellera Biologics (NASDAQ:ABCL) said its first quarter of 2026 was marked by progress in its internal drug pipeline, including interim Phase 1 data for its lead program, ABCL635, and continued preparation for multiple clinical catalysts expected over the next two years. President and CEO Dr. Carl Hansen said the company entered 2026 in a “strong financial position,” with major platform and infrastructure projects “substantially complete” and its internal pipeline positioned for several upcoming readouts. The company’s priorities for the year include top-line data for ABCL635 and ABCL575, advancing ABCL688 and ABCL386 through IND-enabling activities, and adding at least one new development candidate. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum The most closely watched milestone is the Phase 2 readout for ABCL635, which Hansen said remains expected in the third quarter of 2026. The program is being developed as a potential first-in-class antibody medicine for the non-hormonal treatment of moderate to severe vasomotor symptoms, or hot flashes, associated with menopause. Chief Medical Officer Dr. Sarah Noonberg presented interim Phase 1 data for ABCL635, an antibody targeting NK3R, a GPCR target that has been clinically validated in hot flashes. The Phase 1 trial was a randomized, double-blind, placebo-controlled study in healthy volunteers, including a single ascending dose portion and a multiple ascending dose portion. → 3 Ways to Target the Resources Powering AI and Data Centers Noonberg said unblinded data from the single ascending dose portion showed that ABCL635 was “generally well-tolerated.” Across cohorts, there were no reports of serious adverse events, severe adverse events, adverse events leading to discontinuation, or liver toxicity. She said the absence of liver-related adverse events was “an important differentiator” for the program. The overall incidence of any adverse event was 50% in both the ABCL635 treatment group and the pooled placebo group. Most reported adverse events were grade 1. Noonberg said the only potential signal was self-limiting headache clustered in the 900 mg cohort, generally mild and resolving without complication. No headache adverse events were reported in the 600 mg cohort. → Quantum Earnings Season Is Ramping Up—What to Watch From 2 Major Players ABCL635 also showed pharmacokinetic characteristics that the company believes support monthly subcutaneous dosing. Noonberg said the drug exhibited “favorable linear pharmacokinetics” across doses, with low variability and an estimated half-life of about 24 days. A key question for the program was whether an antibody could access NK3R in the hypothalamus. Noonberg said testosterone levels in men were used as a surrogate biomarker for NK3R target engagement, based on prior validation in the early development of the small molecule fezolinetant. According to Noonberg, a single dose of ABCL635 produced sustained, dose-dependent testosterone suppression in men over a four-week period, with recovery to baseline by eight to 12 weeks. She said doses of 300 mg, 600 mg and 900 mg were associated with sustained testosterone reductions of 50% to more than 75% for several weeks. The company also observed dose-dependent suppression of FSH and LH at those doses. “Based on these pharmacodynamic data, we feel confident that ABCL635 is able to reach the KNDy neurons in the infundibular nucleus, and we have addressed an important scientific risk for this program,” Noonberg said. The ongoing Phase 2 portion is a randomized, double-blind, placebo-controlled, multicenter study of approximately 80 patients with moderate to severe vasomotor symptoms. Participants receive a single 600 mg dose of ABCL635 or placebo. The primary efficacy endpoint is at four weeks, with patients followed for an additional eight weeks to evaluate drug concentration and efficacy relationships. Noonberg said the Phase 2 study is enrolling well and remains on track for top-line efficacy and safety data in the third quarter. If successful, the company plans to discuss a late-stage development program for menopause-associated vasomotor symptoms and evaluate potential use in hot flashes associated with breast and prostate cancer treatments. Hansen said AbCellera expects a top-line Phase 1 readout for ABCL575 in the fourth quarter of 2026. The company describes ABCL575 as a potential best-in-class OX40L antagonist. Hansen reiterated that AbCellera’s plan is to complete Phase 1 studies before seeking a partner and that the company does not currently intend to develop the program beyond Phase 1 on its own. Beyond ABCL635 and ABCL575, Hansen said the company is on track to have up to three additional clinical-stage programs by the end of 2027. That includes undisclosed programs ABCL688 and ABCL386, which he said are expected to begin clinical development in Phase 1/2 studies with a path to early proof of concept in patients. The company also aims to select a fifth development candidate in the first half of 2026. Chief Financial Officer Andrew Booth said AbCellera ended the quarter with approximately CAD 531 million in cash equivalents and marketable securities, down CAD 30 million from the prior quarter. He said the company has roughly CAD 125 million in available committed government funding, bringing available liquidity to approximately CAD 655 million. Revenue for the quarter was about CAD 8 million, compared with approximately CAD 4 million in the same quarter of 2025, consisting mostly of research fees. Booth said research fee revenue is expected to trend lower as the company focuses on its internal pipeline. Research and development expenses were approximately $47 million, about $4 million higher than a year earlier, reflecting investment in internal programs. Sales, general and administrative expenses were about $12 million, compared with roughly $19 million last year. Booth said the more than 35% decrease was related to the conclusion of intellectual property litigation and team changes tied to the internal pipeline focus. AbCellera reported a net loss of roughly $43 million for the first quarter, compared with a loss of about $46 million a year earlier. The loss was $0.14 per share on a basic and diluted basis. Booth said the company continues to believe it has sufficient liquidity to fund at least the next three years of pipeline investments. During the question-and-answer session, analysts focused heavily on the interpretation of ABCL635’s testosterone suppression data and how it may translate into efficacy for patients with hot flashes. Hansen cautioned that the biomarker is not a direct measure of efficacy, saying the Phase 2 trial is designed to answer that question. Hansen said the company’s base commercial profile for ABCL635 would be a product with efficacy comparable to small molecules, a cleaner safety profile without liver monitoring and once-monthly subcutaneous dosing. Noonberg added that the 12-week follow-up in Phase 2 should help the company build a pharmacokinetic and pharmacodynamic model to support discussions with regulators about late-stage development. AbCellera Biologics Inc (NASDAQ: ABCL) is a biotechnology company specializing in the discovery and development of therapeutic antibodies. The company's technology platform integrates single-cell screening, microfluidics, high-throughput sequencing and artificial intelligence to rapidly identify and optimize antibody candidates against a wide range of disease targets. By combining experimental data with machine learning, AbCellera accelerates early-stage drug discovery and improves the efficiency of lead candidate selection. AbCellera primarily operates through partnerships with pharmaceutical and biotechnology firms, offering its antibody discovery services on a fee-for-service and milestone-driven basis. 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 "AbCellera Biologics Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

