Rheumatoid Arthritis Treatment Market 2034: EMA, PDMA, FDA Approval, Clinical Trials, Epidemiology, Revenue, Statistics, Therapies, and Companies by DelveInsight
Rheumatoid Arthritis Companies are Regeneron/Sanofi, Eli Lilly and Company, UCB BIOSCIENCES GmbH, AbbVie, Pfizer, Changchun GeneScience Pharma, Novartis, Istituto Giannina Gaslini, and others.
(Albany, USA) DelveInsight's "Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2034" report delivers an in-depth understanding of rheumatoid arthritis, historical and forecasted epidemiology as well as the Rheumatoid arthritis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The Rheumatoid Arthritis market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Rheumatoid Arthritis market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Rheumatoid Arthritis treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Rheumatoid Arthritis market.
Key Takeaways from the Rheumatoid Arthritis Market Report
According to DelveInsight, Rheumatoid Arthritis Market Size in the 7MM was estimated to be around USD 29,000 million in 2023, which is expected to grow during the forecast period (2024–2034).
Among the 7MM, the US accounted for the highest prevalent cases of rheumatoid arthritis in 2023, with around 1,430,000 cases were diagnosed with rheumatoid arthritis. Moreover, these cases are expected to increase during the forecast period.
Amongst EU4 and the UK, the diagnosed prevalent cases of rheumatoid arthritis were highest in Germany, while the lowest number of cases was in France in 2023.
In the US, the total age-specific prevalent cases of rheumatoid arthritis were highest in the age group for 55-64 years in 2023.
The leading Rheumatoid Arthritis Companies such as Regeneron/Sanofi, Eli Lilly and Company, UCB BIOSCIENCES GmbH, AbbVie, Pfizer, Changchun GeneScience Pharma, Novartis, Istituto Giannina Gaslini, and others.
Promising Rheumatoid Arthritis Therapies such as Sarilumab (Kevzara), Baricitinib, Certolizumab pegol, Upadacitinib, Tofacitinib, Sarilumab SAR153191 (REGN88), GenaKumab, AIN457, Etanercept, and others.
In February 2025, Inmedix® introduced its CloudHRV™ System to U.S. rheumatologists during the Rheumatology Winter Clinical Symposium held in Wailea, Maui. Cleared for commercialization by the U.S. FDA on January 17, 2025, the CloudHRV System is a heart rate variability (HRV) diagnostic tool intended for clinical use at the discretion of healthcare providers.
In February 2025, Zydus Lifesciences received final approval from the U.S. FDA to manufacture Ibuprofen and Famotidine tablets (800 mg/26.6 mg), marketed under the brand name Duexis. This combination therapy is prescribed for the relief of rheumatoid arthritis and osteoarthritis symptoms while also reducing the risk of upper gastrointestinal ulcers associated with long-term ibuprofen use.
In January 2025, Celltrion, a prominent South Korean biopharmaceutical firm, announced U.S. FDA approval for its biosimilar Avtozma. Developed as a biosimilar to Actemra, Avtozma is available in both intravenous and subcutaneous forms and is indicated for autoimmune conditions such as rheumatoid arthritis, giant cell arteritis, and COVID-19.
Additionally, in January 2025, Rise Therapeutics reported that the FDA accepted its Investigational New Drug (IND) application for a Phase 1 oncology trial of R-5780. The company continues to develop treatments targeting ulcerative colitis, rheumatoid arthritis, and type 1 diabetes.
In September 2024, Celltrion announced FDA approval for a Phase 3 clinical study of Zymfentra (CT-P13 SC, infliximab), its subcutaneous Remicade biosimilar, for rheumatoid arthritis treatment.
June 2024:- AbbVie- A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH).
Rheumatoid Arthritis Overview
Rheumatoid Arthritis is a chronic autoimmune disorder that primarily affects the joints, leading to inflammation, pain, and potential joint deformity. Rheumatoid Arthritis occurs when the immune system mistakenly attacks the synovium—the lining of the membranes that surround the joints. Rheumatoid Arthritis symptoms typically include joint stiffness, swelling, fatigue, and reduced range of motion, often affecting the wrists, hands, and knees symmetrically.
Rheumatoid Arthritis diagnosis involves a combination of physical examinations, blood tests for inflammatory markers, and imaging techniques such as X-rays or MRIs to assess joint damage. Rheumatoid Arthritis progression can vary widely, with some individuals experiencing mild symptoms and others facing significant disability if left untreated
Rheumatoid Arthritis treatment focuses on controlling inflammation and slowing disease progression through medications such as Disease-Modifying Anti-Rheumatic Drugs (DMARDs), biologics, and corticosteroids. Rheumatoid Arthritis management may also include lifestyle changes, physical therapy, and in severe cases, surgical intervention.
Rheumatoid Arthritis research continues to advance, aiming for more targeted therapies and earlier diagnosis. Rheumatoid Arthritis awareness is essential for early detection and intervention, which can significantly improve long-term outcomes. Rheumatoid Arthritis patients benefit from a multidisciplinary approach involving rheumatologists, physical therapists, and support groups to enhance quality of life and manage daily challenges.
Learn more about Rheumatoid Arthritis treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ Rheumatoid Arthritis Treatment Market
Rheumatoid Arthritis Epidemiology
The Rheumatoid Arthritis epidemiology section provides insights into the historical and current Rheumatoid Arthritis patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Rheumatoid Arthritis market report also provides the diagnosed patient pool, trends, and assumptions.
Rheumatoid Arthritis Epidemiology Segmentation:
Download the report to understand which factors are driving Rheumatoid Arthritis Epidemiology trends @ Rheumatoid Arthritis Prevalence
Rheumatoid Arthritis Marketed Drugs
• OLUMIANT (barticinib): Eli Lilly and Company/Incyte Corporation
OLUMIANT is an immunosuppressant that is indicated for use in inflammatory and autoimmune diseases, or in other terms, it is defined as a Janus kinase (JAK) inhibitor used to treat adults with moderate to severe RA who have not responded well enough to or could not tolerate at least one medicine called a tumor necrosis factor (TNF) antagonist. This novel agent achieved its approval on the basis of well-conducted late-stage clinical trials in countries like the US, Europe, and Japan. OLUMIANT is approved with a Boxed Warning for the risk of serious infections, malignancies, and thrombosis. Currently, OLUMIANT is conducting a Phase II trial (NCT04870203) in combination with adalimumab in rheumatoid arthritis
• RINVOQ (upadacitinib): AbbVie
RINVOQ- an AbbVie product is a prescription medicine used to treat adults with moderate to severe RA in whom methotrexate did not work well or could not be tolerated. In August 2019, AbbVie announced that the US FDA has approved RINVOQ for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate.
Rheumatoid Arthritis Emerging Drugs
• Rabeximod (Rob 803): Cyxone
Rabeximod is an orally available drug with a unique mechanism of action that selectively targets the inflammatory macrophage, a type of white blood cell that is the central orchestrator of the inflammatory process that causes tissue destruction and clinical symptoms in rheumatoid arthritis. Rabeximod has been extensively studied in Phase I and Phase II clinical trials. Safety studies reveal a favorable safety profile compared to anti-rheumatoid arthritis drugs such as anti-TNFα monoclonal antibodies and oral JAK inhibitors. In June 2022, Cyxone received a response from a Type B pre-IND meeting with the US FDA. The response from the FDA facilitates for Cyxone to continue planning the Phase IIb study with Rabeximod in rheumatoid arthritis.
• Imvotamab: IGM Biosciences
Imvotamab is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins. It has 10 binding units for CD20, and it may successfully bind to CD20 expressing B cells with more power (avidity) compared to an IgG bispecific antibody with only one or two binding units for CD20. The company is currently evaluating Imvotamab in Phase-Ib trial for severe rheumatoid arthritis and mostly autoimmune diseases mediated by B-cells. Additionally, in vitro studies show that Imvotamab is significantly more effective than rituximab in depleting low CD20 expressing cells.
Rheumatoid Arthritis Market Outlook
Rheumatoid Arthritis aims to control pain and inflammation and, ultimately, the goal is remission or at least low disease activity. The FDA that can slow the course of the disease and improve the quality of life has approved scarcely any drugs. Therefore, the management of rheumatoid arthritis remains supportive and symptom-based. In recent years, research on new treatment strategies has increased, taking heed of monoclonal antibodies, small molecules, and others. There are limited approved drugs that slow disease progression by prolonging autonomy and increasing survival rates. Moreover, approved by the US FDA to treat rheumatoid arthritis, including OLUMIANT, RINVOQ, and ORENCIA.
Rheumatoid Arthritis Drug Market
The pipeline holds multiple promising therapies in various stages of development, most of which are vaccines. Therapies like Rabeximod (Cyxon), Imvotamab (IGM Biosciences), and others are the drugs and Monoclonal antibodies currently in Phase II and Ib trials focusing on Macrophage inhibition and CD cells depletion, and more may follow in the future. The current pipeline does not hold great potential as most of the products are currently in initial and mid stage trials and most of the drugs failed in their last stage trials as the studies did not meet primary and secondary efficacy endpoints in rheumatoid arthritis treatment. However, Rabeximod by Cyxone is a new drug candidate and unique among marketed drugs as well as drugs in development as it selectively targets rheumatoid arthritis via the NFkB pathway of inflammatory macrophages, the central orchestrators of the inflammatory process responsible for tissue destruction and clinical symptoms in rheumatoid arthritis.
Scope of the Rheumatoid Arthritis Market Report
Coverage- 7MM
Rheumatoid Arthritis Companies- Major pharmaceutical and biotechnology companies such as Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), Sanofi (EPA: SAN), Eli Lilly and Company (NYSE: LLY), UCB BIOSCIENCES GmbH (part of UCB S.A., EBR: UCB), AbbVie Inc. (NYSE: ABBV), Pfizer Inc. (NYSE: PFE), Changchun GeneScience Pharma (SHE: 000661), Novartis (SWX: NOVN), Istituto Giannina Gaslini, and others.
Rheumatoid Arthritis Therapies- Sarilumab (Kevzara), Baricitinib, Certolizumab pegol, Upadacitinib, Tofacitinib, Sarilumab SAR153191 (REGN88), GenaKumab, AIN457, Etanercept, and others.
Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis Market Drivers and Barriers
Rheumatoid Arthritis Market Access and Reimbursement, Unmet Needs and Future Perspectives
Discover more about Rheumatoid Arthritis Drugs in development @ Rheumatoid Arthritis Clinical Trials Assessment and Pipeline Analysis
Table of Content
1 Key Insights
2 Report Introduction
3 Executive Summary
4 Key Events
5 Epidemiology and Market Forecast Flow Methodology
6 Rheumatoid Arthritis Market Overview at a Glance
7 Disease Background and Overview
8 Treatment and Management of Rheumatoid Arthritis
9 Guidelines for Management of Rheumatoid Arthritis with Synthetic and Biological Disease-modifying Antirheumatic Drugs (European Alliance of Associations for Rheumatology)
10 Treatment Guidelines for RA (National Institute for Health and Care Excellence)
11 Guidelines for Management of RA (American College of Rheumatology)
12 Clinical Practice Guidelines for RA (Italian Society for Rheumatology)
13 Guidelines for the use of methotrexate in patients with Rheumatoid Arthritis (Japan College of Rheumatology (JCR))
14 Treatment Algorithm
15 Epidemiology and Patient Population of 7MM
16 Patient Journey
17 Key Endpoints in Rheumatoid Arthritis Clinical Trials
18 Marketed Drugs
19 Emerging Drugs
20 Rheumatoid arthritis: 7MM Market Analysis
21 Unmet Needs
22 SWOT Analysis
23 Market Access and Reimbursement of Rheumatoid Arthritis Therapies
24 KOL Views
25 Appendix
26 DelveInsight Capabilities
27 Disclaimer
28 About DelveInsight
About DelveInsight
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Globe and Mail
01-08-2025
- Globe and Mail
Regeneron Reports Second Quarter 2025 Financial and Operating Results
Second quarter 2025 revenues increased 4% to $3.68 billion versus second quarter 2024 Dupixent ® global net sales (recorded by Sanofi) increased 22% to $4.34 billion EYLEA HD ® U.S. net sales increased 29% to $393 million; total EYLEA HD and EYLEA ® U.S. net sales decreased 25% to $1.15 billion GAAP EPS increased 3% to $12.81; non-GAAP EPS (a) increased 12% to $12.89 FDA approved Lynozyfic ™ (linvoseltamab) for relapsed or refractory multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria (CSU) FDA accepted for priority review Libtayo ® sBLA for adjuvant cutaneous squamous cell carcinoma (CSCC) In-licensed rights to late-stage dual GLP-1/GIP receptor agonist; reported interim 26-week data from Phase 2 COURAGE trial in obesity TARRYTOWN, N.Y., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the second quarter of 2025 and provided a business update. "Regeneron had a strong quarter, marked by significant growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo along with multiple regulatory approvals," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We have made significant progress in our oncology portfolio, including FDA approval for Lynozyfic for relapsed or refractory multiple myeloma, exciting emerging data from the lead-in cohorts of our pivotal programs in myeloma and lymphoma, as well as positive pivotal data supporting a potential upcoming FDA approval for Libtayo in adjuvant CSCC. Dupixent continues to be the world-leading treatment for diseases driven by type 2 inflammation, adding recent FDA approvals for bullous pemphigoid and chronic spontaneous urticaria, the seventh and eighth distinct indications for this important medicine. We are confident in the near- and long-term potential of our diverse pipeline and look forward to additional data and regulatory milestones later this year." Financial Highlights ($ in millions, except per share data) Q2 2025 Q2 2024 % Change Total revenues $ 3,676 $ 3,547 4 % GAAP net income $ 1,392 $ 1,432 (3 %) GAAP net income per share - diluted $ 12.81 $ 12.41 3 % Non-GAAP net income (a) $ 1,424 $ 1,351 5 % Non-GAAP net income per share - diluted (a) $ 12.89 $ 11.56 12 % "We are pleased with our second quarter financial performance, which reflects strong momentum across our business, highlighted by 4% revenue growth and 12% non-GAAP earnings growth," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "While we continue to prioritize internal investments, we also returned over $2.3 billion of capital to shareholders through share repurchases and dividends and committed over $7 billion to U.S. manufacturing investments, capital expenditures, and business development since the start of 2025, underscoring our commitment to deploy capital with the goal of driving long-term value creation." Business Highlights Key Pipeline Progress Regeneron has approximately 45 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent (dupilumab) In June 2025, the FDA approved Dupixent for the treatment of adults with bullous pemphigoid. Regulatory applications are under review in the European Union (EU) and Japan. In April 2025, the FDA approved Dupixent for the treatment of adults and adolescents aged 12 years and older with CSU who remain symptomatic despite antihistamine treatment. Regulatory applications were submitted to the FDA and in the EU for CSU in children aged 2 to 11 years. EYLEA HD (aflibercept) 8 mg The European Commission (EC) approved EYLEA 8 mg with extended dosing intervals of up to 6 months (24 weeks) for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The Company now expects regulatory approvals to be delayed for its currently pending FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of macular edema following retinal vein occlusion), which have PDUFA dates in August 2025. The anticipated delay is related to observations from an FDA general site inspection at the filler for EYLEA HD in these regulatory applications, Catalent Indiana LLC (recently acquired by Novo Nordisk A/S). This inspection was completed in mid-July and was not specific to EYLEA HD. Novo has been in communication with the FDA and expects to submit its response next week. Based on the Company's review of the observations and Novo's proposed response to the FDA, along with the progress the Company has made with alternate third-party fillers, the Company anticipates an expeditious resolution of the filling issues for EYLEA HD. Oncology Programs In July 2025, the FDA granted accelerated approval for Lynozyfic (linvoseltamab) to treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Additionally, the EC granted conditional marketing approval of Lynozyfic to treat adults with relapsed or refractory multiple myeloma who have received at least three prior therapies. In July 2025, Lynozyfic was added to the National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of multiple myeloma. The FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab) in adjuvant CSCC, with a target action date in October 2025. The Company announced detailed analyses from a Phase 3 trial of Libtayo in adjuvant CSCC. The results, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine, included additional data for the primary endpoint of disease-free survival (DFS) and the first presentation of key secondary endpoint outcomes. On July 30, 2025, the FDA issued a Complete Response Letter (CRL) for the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, which was also impacted by the Catalent Indiana LLC site inspection (as described above). Other Programs The Company announced interim 26-week results from the ongoing Phase 2 COURAGE trial investigating combinations of semaglutide and trevogrumab (myostatin antibody) with or without garetosmab (Activin A antibody) for the treatment of obesity. The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab preserved lean mass while increasing loss of fat mass. Final 26-week efficacy and safety results were consistent with the interim data and will be presented at the 61 st Annual Meeting of the European Association for the Study of Diabetes (EASD) in September 2025. A Phase 3 study for REGN7508, an antibody to Factor XI (catalytic domain), was initiated to evaluate the prevention of venous thromboembolism after total knee replacement surgery. Initiation of additional Phase 3 studies is planned for later this year and the first half of 2026. The Company and Sanofi announced that a Phase 3 trial, AERIFY-1, for itepekimab, an antibody to IL-33, in adults who were former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. The Company and Sanofi continue to evaluate the data to inform next steps for potential future COPD development. Corporate and Business Development Updates In July 2025, the Company's license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective. In-licensing a late-stage GLP1/GIP agonist enables the Company to study combinations with its products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions. A jury verdict in the U.S. District Court for the District of Delaware found that Amgen Inc. violated antitrust and tort laws by creating an anticompetitive bundling scheme which was designed to exclude Praluent from the market. In June 2025, the Company announced the launch of a matching program for donations to Good Days, an independent national non-profit charitable organization, to support their Retinal Vascular and Neovascular Disease Fund. The Company has committed to matching donations up to a total of $200 million at a one-to-one rate through the end of 2025, with the goal of enabling more patients to affordably access essential medicines that help protect their vision. The Company acquired an FDA Rare Pediatric Disease Priority Review Voucher from a third party for $155 million. Second Quarter 2025 Financial Results Revenues ($ in millions) Q2 2025 Q2 2024 % Change Net product sales: EYLEA HD - U.S. $ 393 $ 304 29 % EYLEA - U.S. 754 1,231 (39 %) Total EYLEA HD and EYLEA - U.S. 1,147 1,535 (25 %) Libtayo - U.S. 248 182 36 % Libtayo - ROW* 129 115 12 % Total Libtayo - Global 377 297 27 % Praluent ® - U.S. 66 56 18 % Evkeeza ® - U.S. 41 31 32 % Total net product sales 1,631 1,919 (15 %) Collaboration revenue: Sanofi 1,444 1,146 26 % Bayer 415 375 11 % Other 2 3 (33 %) Other revenue 184 104 77 % Total revenues $ 3,676 $ 3,547 4 % * Rest of world (ROW) Net product sales of EYLEA HD increased in the second quarter of 2025, compared to the second quarter of 2024, due to higher sales volumes driven by increased demand. Net product sales of EYLEA in the second quarter of 2025, compared to the second quarter of 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures, loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price. Sanofi collaboration revenue increased in the second quarter of 2025, compared to the second quarter of 2024, due to an increase in the Company's share of profits from the commercialization of antibodies, which were $1.282 billion and $988 million in the second quarter of 2025 and 2024, respectively. The change in the Company's share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales. Refer to Table 4 for a summary of collaboration revenue. Other revenue increased in the second quarter of 2025, compared to the second quarter of 2024, due to an increase in royalties and share of profits earned in connection with license agreements, which were $118 million and $69 million for the second quarter of 2025 and 2024, respectively. Operating Expenses GAAP % Change Non-GAAP (a) % Change ($ in millions) Q2 2025 Q2 2024 Q2 2025 Q2 2024 Research and development (R&D) $ 1,422 $ 1,200 19% $ 1,283 $ 1,072 20% Acquired in-process research and development (IPR&D) $ 10 $ 24 (58%) * * n/a Selling, general, and administrative (SG&A) $ 634 $ 759 (16%) $ 542 $ 667 (19%) Cost of goods sold (COGS) $ 276 $ 258 7% $ 222 $ 214 4% Gross margin on net product sales (c) 83% 87% 86% 89% Cost of collaboration and contract manufacturing (COCM) (d) $ 255 $ 222 15% * * n/a Other operating expense (income), net $ — $ 15 (100%) * $ — —% * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded GAAP and non-GAAP R&D expenses increased in the second quarter of 2025, compared to the second quarter of 2024, driven by the advancement of the Company's mid- and late-stage clinical pipeline. GAAP and non-GAAP SG&A expenses decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization. GAAP and non-GAAP gross margin on net product sales decreased in the second quarter of 2025, compared to the second quarter of 2024, partly due to ongoing investments to support the Company's manufacturing operations and higher inventory write-offs and reserves in the second quarter of 2025 compared to the second quarter of 2024. Other Financial Information GAAP other income (expense), net included the recognition of net unrealized gains on equity securities of $250 million in the second quarter of 2025, compared to $393 million in the second quarter of 2024. In the second quarter of 2025, the Company's GAAP effective tax rate (ETR) was 8.4%, compared to 12.0% in the second quarter of 2024. The GAAP ETR decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to the net change in uncertain tax positions, partly offset by lower tax benefits from less stock option exercises. During the second quarter of 2025, the release of liabilities for uncertain tax positions recognized upon the effective settlement of an IRS audit reduced the Company's GAAP ETR by 3.9%. In the second quarter of 2025, the non-GAAP ETR was 8.3%, compared to 10.8% in the second quarter of 2024. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. Capital Allocation During the second quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $1.070 billion, as Treasury Stock. As of June 30, 2025, $2.814 billion remained available for share repurchases under the Company's share repurchase programs. In July 2025, the Company's board of directors declared a cash dividend of $0.88 per share on the Company's common stock and Class A stock, payable on September 3, 2025 to shareholders of record as of August 18, 2025. 2025 Financial Guidance (b) The Company's full year 2025 financial guidance consists of the following components: 2025 Guidance Prior Updated GAAP R&D $5.560–$5.795 billion $5.660–$5.790 billion Non-GAAP R&D (a) $5.000–$5.200 billion $5.100–$5.200 billion GAAP SG&A $2.910–$3.095 billion $2.810–$2.940 billion Non-GAAP SG&A (a) $2.550–$2.700 billion $2.450–$2.550 billion GAAP gross margin on net product sales 83%–84% Approximately 83% Non-GAAP gross margin on net product sales (a) 86%–87% Approximately 86% COCM * $1.000–$1.150 billion $1.000–$1.050 billion Capital expenditures * $850–$950 million $880–$950 million GAAP effective tax rate 9%–11% 11%–13% Non-GAAP effective tax rate (a) 11%–13% Unchanged * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below: Projected Range ($ in millions) Low High GAAP R&D $ 5,660 $ 5,790 Stock-based compensation expense 560 590 Non-GAAP R&D $ 5,100 $ 5,200 GAAP SG&A $ 2,810 $ 2,940 Stock-based compensation expense 360 390 Non-GAAP SG&A $ 2,450 $ 2,550 GAAP gross margin on net product sales 83% 83% Intangible asset amortization expense 2% 2% Stock-based compensation expense 1% 1% Non-GAAP gross margin on net product sales 86% 86% GAAP ETR 11% 13% Income tax effect of GAAP to non-GAAP reconciling items <1% <1% Non-GAAP ETR 11% 13% (a) This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP other operating (income) expense, net, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as acquisition and integration costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flow, the Company believes that this non-GAAP measure provides a further measure of the Company's ability to generate cash flows from its operations. Additionally, the non-GAAP measures presented are intended to provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by the Company should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. (b) The Company's 2025 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release. (c) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. (d) Corresponding reimbursements from collaborators and others for manufacturing product is recorded within revenues. Conference Call Information Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2025 financial and operating results on Friday, August 1, 2025, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron's website at Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. About Regeneron Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using its proprietary technologies, such as VelociSuite ®, which produces optimized fully human antibodies and new classes of bispecific antibodies. Regeneron is shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center ® and pioneering genetic medicine platforms, enabling Regeneron to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook, or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, competing drugs and product candidates that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") (including biosimilar versions of Regeneron's Products); uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned, including without limitation EYLEA HD ® (aflibercept) Injection 8 mg, EYLEA ® (aflibercept) Injection, Dupixent ® (dupilumab), Libtayo ® (cemiplimab), Praluent ® (alirocumab), Kevzara ® (sarilumab), Evkeeza ® (evinacumab), Veopoz ® (pozelimab), Ordspono ™ (odronextamab), Lynozyfic ™ (linvoseltamab), other clinical programs discussed in this press release, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones described in this press release; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance, including GAAP and non-GAAP R&D, GAAP and non-GAAP SG&A, GAAP and non-GAAP gross margin on net product sales, COCM, capital expenditures, and GAAP and non-GAAP ETR; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2024 and its Form 10-Q for the quarterly period ended June 30, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided reconciliations of such non-GAAP financial measures. TABLE 1 TABLE 2 REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In millions, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenues: Net product sales $ 1,631.0 $ 1,918.6 $ 3,046.6 $ 3,679.9 Collaboration revenue 1,860.7 1,524.0 3,391.9 2,790.8 Other revenue 183.9 104.5 265.8 221.4 3,675.6 3,547.1 6,704.3 6,692.1 Expenses: Research and development 1,421.7 1,200.0 2,749.1 2,448.4 Acquired in-process research and development 10.0 23.9 22.3 31.0 Selling, general, and administrative 634.2 758.8 1,267.2 1,447.8 Cost of goods sold 275.6 257.8 541.1 498.2 Cost of collaboration and contract manufacturing 254.6 222.4 453.4 415.8 Other operating expense (income), net — 14.6 — 29.9 2,596.1 2,477.5 5,033.1 4,871.1 Income from operations 1,079.5 1,069.6 1,671.2 1,821.0 Other income (expense): Other income (expense), net 442.8 573.3 764.8 538.7 Interest expense (3.6) (14.8) (12.3) (30.9) 439.2 558.5 752.5 507.8 Income before income taxes 1,518.7 1,628.1 2,423.7 2,328.8 Income tax expense 127.1 195.8 223.4 174.5 Net income $ 1,391.6 $ 1,432.3 $ 2,200.3 $ 2,154.3 Net income per share - basic $ 13.24 $ 13.25 $ 20.78 $ 19.95 Net income per share - diluted $ 12.81 $ 12.41 $ 20.02 $ 18.68 Weighted average shares outstanding - basic 105.1 108.1 105.9 108.0 Weighted average shares outstanding - diluted 108.6 115.4 109.9 115.3 TABLE 3 Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP R&D $ 1,421.7 $ 1,200.0 $ 2,749.1 $ 2,448.4 Stock-based compensation expense 139.0 122.4 280.0 245.4 Acquisition and integration costs — 5.3 — 9.1 Non-GAAP R&D $ 1,282.7 $ 1,072.3 $ 2,469.1 $ 2,193.9 GAAP SG&A $ 634.2 $ 758.8 $ 1,267.2 $ 1,447.8 Stock-based compensation expense 91.8 82.6 187.0 168.8 Acquisition and integration costs — 9.7 0.8 28.5 Non-GAAP SG&A $ 542.4 $ 666.5 $ 1,079.4 $ 1,250.5 GAAP COGS $ 275.6 $ 257.8 $ 541.1 $ 498.2 Stock-based compensation expense 20.9 18.2 40.4 39.1 Acquisition and integration costs — 0.8 — 1.2 Intangible asset amortization expense 32.4 25.1 61.1 48.3 Non-GAAP COGS $ 222.3 $ 213.7 $ 439.6 $ 409.6 GAAP other operating expense (income), net $ — $ 14.6 $ — $ 29.9 Change in fair value of contingent consideration — 14.6 — 29.9 Non-GAAP other operating expense (income), net $ — $ — $ — $ — GAAP other income (expense), net $ 439.2 $ 558.5 $ 752.5 $ 507.8 Gains on investments, net (250.0) (392.6) (389.9) (196.5) Non-GAAP other income (expense), net $ 189.2 $ 165.9 $ 362.6 $ 311.3 GAAP net income $ 1,391.6 $ 1,432.3 $ 2,200.3 $ 2,154.3 Total of GAAP to non-GAAP reconciling items above 34.1 (113.9) 179.4 373.8 Income tax effect of GAAP to non-GAAP reconciling items (2.1) 32.8 (27.7) (61.0) Non-GAAP net income $ 1,423.6 $ 1,351.2 $ 2,352.0 $ 2,467.1 Non-GAAP net income per share - basic $ 13.55 $ 12.50 $ 22.21 $ 22.84 Non-GAAP net income per share - diluted $ 12.89 $ 11.56 $ 21.06 $ 21.09 Shares used in calculating: Non-GAAP net income per share - basic 105.1 108.1 105.9 108.0 Non-GAAP net income per share - diluted 110.4 116.9 111.7 117.0 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Effective tax rate reconciliation: GAAP ETR 8.4 % 12.0 % 9.2 % 7.5 % Income tax effect of GAAP to non-GAAP reconciling items (0.1 %) (1.2 %) 0.4 % 1.2 % Non-GAAP ETR 8.3 % 10.8 % 9.6 % 8.7 % Gross margin on net product sales reconciliation: GAAP gross margin on net product sales 83 % 87 % 82 % 86 % Intangible asset amortization expense 2 % 1 % 2 % 2 % Stock-based compensation expense 1 % 1 % 2 % 1 % Non-GAAP gross margin on net product sales 86 % 89 % 86 % 89 % Six Months Ended June 30, 2025 2024 Free cash flow reconciliation: Net cash provided by operating activities $ 2,189.5 $ 1,866.5 Capital expenditures (448.3) (314.4) Free cash flow $ 1,741.2 $ 1,552.1 TABLE 4 REGENERON PHARMACEUTICALS, INC. (In millions) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Sanofi collaboration revenue: Regeneron's share of profits in connection with commercialization of antibodies $ 1,282.1 $ 988.3 $ 2,300.2 $ 1,792.3 Reimbursement for manufacturing of commercial supplies 161.5 157.3 326.6 263.1 Total Sanofi collaboration revenue 1,443.6 1,145.6 2,626.8 2,055.4 Bayer collaboration revenue: Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States 383.4 353.0 700.7 686.9 Reimbursement for manufacturing of commercial supplies 31.6 22.1 58.2 44.2 Total Bayer collaboration revenue 415.0 375.1 758.9 731.1 Other collaboration revenue 2.1 3.3 6.2 4.3 Total collaboration revenue $ 1,860.7 $ 1,524.0 $ 3,391.9 $ 2,790.8 TABLE 5 Three Months Ended June 30, 2025 2024 % Change U.S. ROW Total U.S. ROW Total (Total Sales) EYLEA HD (a) $ 393.2 $ 241.7 $ 634.9 $ 304.2 $ 59.1 $ 363.3 75 % EYLEA (a) $ 754.3 $ 736.0 $ 1,490.3 $ 1,230.5 $ 848.7 $ 2,079.2 (28 %) Total EYLEA HD and EYLEA $ 1,147.5 $ 977.7 $ 2,125.2 $ 1,534.7 $ 907.8 $ 2,442.5 (13 %) Dupixent (b) $ 3,205.0 $ 1,139.6 $ 4,344.6 $ 2,610.2 $ 946.2 $ 3,556.4 22 % Libtayo (c) $ 247.8 $ 128.7 $ 376.5 $ 182.4 $ 115.0 $ 297.4 27 % Praluent (d) $ 65.8 $ 156.2 $ 222.0 $ 56.1 $ 135.8 $ 191.9 16 % Kevzara (b) $ 95.7 $ 56.5 $ 152.2 $ 65.1 $ 44.6 $ 109.7 39 % Other products (e) $ 42.1 $ 30.0 $ 72.1 $ 30.9 $ 21.9 $ 52.8 37 % Six Months Ended June 30, 2025 2024 % Change U.S. ROW Total U.S. ROW Total (Total Sales) EYLEA HD (a) $ 700.0 $ 388.1 $ 1,088.1 $ 504.2 $ 74.3 $ 578.5 88 % EYLEA (a) $ 1,490.3 $ 1,447.4 $ 2,937.7 $ 2,432.1 $ 1,682.9 $ 4,115.0 (29 %) Total EYLEA HD and EYLEA $ 2,190.3 $ 1,835.5 $ 4,025.8 $ 2,936.3 $ 1,757.2 $ 4,693.5 (14 %) Dupixent (b) $ 5,834.4 $ 2,175.8 $ 8,010.2 $ 4,828.2 $ 1,805.0 $ 6,633.2 21 % Libtayo (c) $ 440.3 $ 221.3 $ 661.6 $ 341.6 $ 219.7 $ 561.3 18 % Praluent (d) $ 122.6 $ 292.7 $ 415.3 $ 126.1 $ 267.1 $ 393.2 6 % Kevzara (b) $ 168.5 $ 100.1 $ 268.6 $ 115.1 $ 88.7 $ 203.8 32 % Other products (e) $ 73.2 $ 53.5 $ 126.7 $ 56.2 $ 40.8 $ 97.0 31 % Note: The table above includes net product sales of Regeneron-discovered products. Such net product sales are recorded by the Company or others, as further described in the footnotes below. (a) The Company records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States within Collaboration revenue. (b) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products within Collaboration revenue (c) The Company records global net product sales of Libtayo and pays Sanofi a royalty on such sales (d) The Company records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales, which is recorded within Other revenue. (e) Included in this line item are products which are sold by the Company and others. Refer to "Second Quarter 2025 Financial Results" section above for a complete listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST ®, which are recorded by Kiniksa.
Globe and Mail
30-07-2025
- Globe and Mail
Sleep Apnea Pipeline Outlook Report 2025: Key 10+ Companies and Breakthrough Therapies Shaping the Future Landscape
DelveInsight's, 'Sleep Apnea Pipeline Insight, 2025' report provides comprehensive insights about 10+ companies and 14+ pipeline drugs in Sleep Apnea pipeline landscape. It covers the Sleep Apnea pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Sleep Apnea pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Sleep Apnea Treatment Landscape. Click here to read more @ Sleep Apnea Pipeline Outlook Key Takeaways from the Sleep Apnea Pipeline Report In July 2025, Mineralys Therapeutics Inc. announced a study is a randomized, double-blind (DB), placebo controlled, crossover study. A 4-week screening period is followed by two DB 4-week treatment periods separated by a 2-week washout period. Participants must be 18 to 75 years old with moderate to severe OSA, hypertension and meet all applicable eligibility criteria. Participants who are medically prescribed and deemed compliant with positive airway pressure (PAP) therapy for greater than or equal to (>=) 4 hours per night (Continuous PAP [CPAP], or automatic PAP [autoPAP]) and for at least 3 months prior to the study enrollment are eligible for the study. In July 2025, Eli Lilly and Company announced a study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study. DelveInsight's Sleep Apnea pipeline report depicts a robust space with 10+ active players working to develop 14+ pipeline therapies for Sleep Apnea treatment. The leading Sleep Apnea Companies such as Apnimed, Incannex Healthcare, Fujian Shengdi Pharmaceutical, Eli Lilly and Company, RespireRx Phamaceuticals, Neurim Pharmaceuticals and others. Promising Sleep Apnea Pipeline Therapies such as Sivopixant, Acetazolamide, SAS0421a, VI-0521, Zonisamide, Sulthiame, AD128, BAY2586116 and others. Stay informed about the cutting-edge advancements in Sleep Apnea Treatments. Download for updates and be a part of the revolution in dermatology care @ Sleep Apnea Clinical Trials Assessment Sleep Apnea Emerging Drugs Profile AD109: Apnimed AD109 is an investigational oral therapy, a pill designed to target the underlying neuromuscular dysfunction in people living with mild, moderate, and severe obstructive sleep apnea (OSA). This novel treatment targets the hypoglossal motor nucleus (HMN) to increase signals in the upper airway dilator muscles during sleep to limit or prevent airway collapse. It is a potential first-in-class, novel, investigational combination dosed once daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines company's novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine). AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of current standard of care treatments that can be poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices). Currently, the drug is in the Phase III stage of its development for the treatment of Obstructive Sleep Apnea. Dronabinol: RespireRx Phamaceuticals Dronabinol is a synthetic form of tetrahydrocannabinol (THC), the active compound in cannabis, primarily used to treat nausea, vomiting, and appetite loss. Research has shown potential for dronabinol in treating sleep apnea by stimulating the body's endocannabinoid receptors, which may help reduce apnea episodes and stabilize breathing during sleep. While not yet FDA-approved for sleep apnea, clinical studies suggest it could be beneficial in managing obstructive sleep apnea (OSA) symptoms. Currently, the drug is in the Phase II stage of its development for the treatment of Sleep Apnea. Gal 475: Neurim Pharmaceuticals GAL-475 is a novel therapeutic agent for the treatment of sleep apnea syndromes. In a series of in vitro and in vivo studies in various animal models it demonstrated improvements in sleep apnea indices with reductions in both the frequency and severity of events, without stimulating minute ventilation or disturbing sleep. Preclinical pharmacology studies with GAL-475 suggest that the compound acts predominantly as a peripheral chemoreception modulator, and indicate that the compound is effective in increasing respiratory drive to the upper airways and ameliorating obstructive apneas and their attendant sequelae in rodent models of obstructive apnea at relatively low plasma levels. The primary site of action for GAL-475 appears to be at the level of the carotid body, a peripheral polymodal chemosensory organ, located at the carotid bifurcation, responsible for sensing changes in partial pressures of O2, CO2 or pH, and activating the brainstem respiratory center to produce hyperventilation. Currently, the drug is in the Phase I stage of its development for the treatment of Sleep Apnea. The Sleep Apnea pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Sleep Apnea with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Sleep Apnea Treatment. Sleep Apnea Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Sleep Apnea Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Sleep Apnea market. Get a detailed analysis of the latest innovations in the Sleep Apnea pipeline. Explore DelveInsight's expert-driven report today! @ Sleep Apnea Unmet Needs Sleep Apnea Companies Apnimed, Incannex Healthcare, Fujian Shengdi Pharmaceutical, Eli Lilly and Company, RespireRx Phamaceuticals, Neurim Pharmaceuticals and others. Sleep Apnea pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Sleep Apnea Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Discover the latest advancements in Sleep Apnea Treatment by visiting our website. Stay informed about how we're transforming the future of Dermatology @ Sleep Apnea Market Drivers and Barriers, and Future Perspectives Scope of the Sleep Apnea Pipeline Report Coverage- Global Sleep Apnea Companies- Apnimed, Incannex Healthcare, Fujian Shengdi Pharmaceutical, Eli Lilly and Company, RespireRx Phamaceuticals, Neurim Pharmaceuticals and others. Sleep Apnea Pipeline Therapies- Sivopixant, Acetazolamide, SAS0421a, VI-0521, Zonisamide, Sulthiame, AD128, BAY2586116 and others. Sleep Apnea Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Sleep Apnea Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III For a detailed overview of our latest research findings and future plans, read the full details of Sleep Apnea Pipeline on our website @ Sleep Apnea Emerging Drugs and Companies Table of Contents Introduction Executive Summary Sleep Apnea: Overview Pipeline Therapeutics Therapeutic Assessment Sleep Apnea– DelveInsight's Analytical Perspective Late Stage Products (Phase III) AD109: Apnimed Drug profiles in the detailed report….. Mid Stage Products (Phase II) Dronabinol: RespireRx Phamaceuticals Drug profiles in the detailed report….. Early Stage Products (Phase I) Gal 475: Neurim Pharmaceuticals Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Products Sleep Apnea Key Companies Sleep Apnea Key Products Sleep Apnea- Unmet Needs Sleep Apnea- Market Drivers and Barriers Sleep Apnea- Future Perspectives and Conclusion Sleep Apnea Analyst Views Sleep Apnea Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
National Post
29-07-2025
- National Post
ImmunoPrecise Antibodies (IPA) Reports Full Fiscal Year 2025 Results, Record Fourth Quarter Revenue, and Record Fourth Quarter Adjusted EBITDA
Article content AUSTIN, Texas — ImmunoPrecise Antibodies Ltd. ('IPA', 'Company', 'we' or 'us') (NASDAQ: IPA), a bio-native AI company operating at the intersection of TechBio and next-generation drug discovery, today announces its financial results for the fiscal year ended April 30, 2025. All numbers are expressed in Canadian dollars unless otherwise noted. Article content Financial Highlights: Article content Article content Achieved strong revenue for Fiscal Year 2025 of $24.5 million Delivered highest-ever fourth quarter revenue of $7.0 million Reported record fourth quarter Adjusted EBITDA of ($0.3) million, reflecting improved operating efficiency Achieved fourth quarter gross margin of 64%, up from 48% from Q4 FY24 BioStrand segment grew over 180% in Fiscal year 2025 and had gross margins approaching 90% BioStrand currently represents over 5% of total annual revenue this year, up from less than 2% in Fiscal Year 2024 Article content : Article content The Company's LENS ai ™ platform demonstrated that it's in silico epitope mapping achieves results on previously unseen antibody–antigen complexes with results that are on par with gold-standard X-ray crystallography—yet delivering structural insights in hours instead of weeks. An important breakthrough using the Company's HYFT®-powered LENS ai platform, as it identified a highly conserved epitope across all four dengue virus serotypes, a key milestone toward developing a potential universal dengue vaccine. Subsequently announced in silico data supporting the vaccine candidate's safety and its ability to activate a balanced immune response. IPA's AI-designed GLP-1 peptides outperformed or matched semaglutide in independent receptor activation studies, further validating the Company's HYFT-driven LENS ai platform. Entered a strategic USD $8–10 million partnership with a publicly traded biotechnology company focused on the discovery and development of antibody-drug conjugates and bispecific antibodies for potential oncology therapeutics. Realigned internal R&D strategy to focus on launching an AI-powered therapeutic pipeline, reinforcing IPA's shift toward a bio-native AI drug discovery model. ImmunoPrecise subsidiary signed material transfer agreement with Biotheus (now BioNTech), for the transfer and evaluation of antibody assets for bispecific tumor-targeting. Successfully engineered antibodies in silico to a challenging tumor target using LENS ai, advancing IPA's vision for accessible, next-generation therapeutics. Appointed industry veteran Jon Lieber to its Board of Directors, bringing over 30 years of strategic leadership across biotech, capital markets, and public company governance, further strengthening IPA's financial oversight and commercial execution. Named Jeff Fried, a recognized healthcare data visionary, to its Advisory Board. Fried has played a key role in advancing IPA's AI platform capabilities, particularly the integration of vector search to support large-scale, AI-driven discovery within LENS ai ecosystem. Regained compliance with Nasdaq minimum bid price requirement, reflecting strengthened investor confidence and continued alignment with strategic listing standards. Article content 'Fiscal 2025 was a record-setting year for IPA across multiple dimensions,' said Dr. Jennifer Bath, ImmunoPrecise Antibodies CEO. 'We delivered strong annual and record fourth quarter revenues, significantly improved gross margins, and achieved one of our strongest adjusted EBITDA performances in the Company's history, with a loss of only $316,000. This reflects our continued progress toward profitability while accelerating innovation through our HYFT-powered LENS ai platform. Our BioStrand segment alone grew by more than 180% in Fiscal 2025, highlighting the strength of our AI-driven pipeline. These results underscore the growing commercial validation of our technology, our strategic collaborations, and our ability to deliver real-world impact through next-generation antibody discovery and therapeutic design.' Article content 'As we look ahead to the next fiscal year, we are well-positioned to build on our momentum. We are poised to refocus our business on AI-based product development utilizing our LENS ai platform, powered by our patented HYFT technology. We anticipate the near-term completion of the previously announced divestiture of our Dutch subsidiary, as part of our continued focus on streamlining operations and aligning resources with strategic priorities. Together, these strategic steps will sharpen our focus, strengthen our core capabilities, and set the stage for an even brighter future for IPA,' concluded Dr. Bath. Article content Fourth Quarter 2025 Financial Results Article content Revenue for the three months ended April 30, 2025, was $7.0 million, representing an 8% increase compared to $6.5 million for the same period in 2024. Article content Gross profit for the three months ended April 30, 2025, was $4.5 million, up from $3.1 million in the same period last year. Gross margin for FY25 rose sharply to 64%, compared to 48% for FY24. This improvement was driven, in part, by a greater contribution from high-margin BioStrand revenues. Article content Research and development ('R&D') expenses totaled $1.1 million, down from $1.3 million in the prior-year quarter, due to reallocating project-related R&D efforts to cost of sales for clients. Article content Sales and marketing expenses increased to $1.0 million, compared to $0.9 million in the same period last year, due to an increase in digital campaign expenses. Article content General and administrative expenses declined to $3.7 million from $4.1 million, driven by ongoing cost control efforts. Article content Operating loss, excluding amortization and non-recurring charges, improved significantly to $1.4 million, compared to $3.2 million in the fourth quarter of Fiscal Year 2024. Article content Net loss narrowed to $2.2 million, a marked improvement from a net loss of $17.6 million in the same quarter last year, which included a $15 million non-cash impairment charge related to BioStrand's goodwill and intangible assets. Article content Adjusted EBITDA loss improved to $0.3 million, compared to a loss of $1.7 million in the fourth quarter of Fiscal Year 2024, reflecting improved gross profits and enhanced operating efficiency. Article content Full Year 2025 Financial Results Article content Revenue for Fiscal Year 2025 was $24.5 million, up slightly (without rounding) from $24.5 million in Fiscal Year 2024. Article content Gross Profit for Fiscal Year 2025 was $13.5 million, a 12.4% increase compared to $12.1 million in Fiscal Year 2024. Gross margin expanded by 600 basis points to 55%, up from 49% in the prior year. This margin improvement was driven by a greater revenue contribution from the high-margin BioStrand segment, coupled with an increased focus on cost efficiencies. Article content Research and development expenses were $4.9 million in Fiscal Year 2025, up from $4.0 million in Fiscal Year 2024, reflecting increased investment in R&D activities within the BioStrand segment. Article content Sales and marketing expenses were $4.3 million in Fiscal Year 2025, compared to $3.5 million in Fiscal Year 2024, reflecting increased spending on advertising related to digital campaign expenses. Article content General and administrative expenses totaled $14.7 million in Fiscal Year 2025, down from $15.6 million in Fiscal Year 2024, reflecting the Company's continued focus on operational efficiency and cost discipline. Article content Operating loss in Fiscal Year 2025, excluding amortization and non-recurring charges, improved to $10.4 million, compared to $11.1 million in Fiscal Year 2024. Article content Net loss in Fiscal Year 2025 was $30.2 million, or $(0.91) per share on a basic and diluted basis, compared to a net loss of $26.1 million or $(1.02) on a basic and diluted basis in Fiscal Year 2024. Article content Total cash, cash equivalents, and marketable securities, including restricted cash, were $10.8 million as of April 30, 2025. Article content Three Months Ended April 30, Year Ended April 30, (in thousands) 2025 $ 2024 $ 2025 $ 2024 $ Net loss (2,161 ) (17,610 ) (30,234 ) (26,115 ) Income taxes 261 (1,214 ) (4,033 ) (2,588 ) Amortization and depreciation 913 1,579 5,119 5,735 Accretion 2 4 10 19 Asset impairment charge — 15,031 21,184 15,031 Foreign exchange realized gain (loss) (33 ) 18 (5 ) 142 Interest expense 209 323 948 849 Interest and other income (3 ) 3 283 (23 ) Unrealized foreign exchange loss (gain) 443 (65 ) 594 (86 ) Share-based expense 53 237 445 1,535 Adjusted EBITDA (316 ) (1,694 ) (5,689 ) (5,501 ) Article content *All financial figures are in Canadian Dollars (CAD) unless otherwise stated. Article content Conference Call and Webcast Details Article content The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Friday, July 29, 2025, at 10:30AM ET. Article content The conference call will be webcast live and available for replay via a link provided in the Events section of the Company's IR pages at Article content ***Participant Dial-In Details*** Article content Participants call one of the allocated dial-in numbers (below) and advise the Operator of either the Conference ID 3224490 or Conference Name. Article content USA / International Toll +1 (646) 307-1963 USA – Toll-Free (800) 715-9871 Canada – Toll-Free (800) 715-9871 Article content ***Webcast Details*** Article content Attendee URL: Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. Article content Anyone listening to the call is encouraged to read the company's periodic reports available on the company's profile at and including the discussion of risk factors and historical results of operations and financial condition in those reports. Article content About ImmunoPrecise Antibodies Ltd. Article content ImmunoPrecise Antibodies Ltd. is an AI-driven biotherapeutic research, technology and scientifically robust life science company that discovers and develops customized and novel antibodies by generating proprietary and patented processes, procedures and innovative approaches to antibody discovery, development, and production. IPA has several subsidiaries in North America and Europe including entities such as Talem Therapeutics LLC, BioStrand BV, ImmunoPrecise Antibodies (Canada) Ltd. and ImmunoPrecise Antibodies (Europe) B.V. (collectively, the 'IPA Family'). Article content For more information, visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable United States and Canadian securities laws. These statements reflect the Company's expectations, plans, projections, and beliefs regarding future events or performance. Words such as 'expects,' 'anticipates,' 'intends,' 'believes,' 'plans,' 'potential,' 'will,' 'may,' 'continue,' and variations thereof are intended to identify forward-looking statements. Article content Forward-looking statements in this release include, but are not limited to, statements related to the Company's operational and financial outlook, the potential impact and continuity of strategic partnerships, including the recently announced commercial agreement and collaborations with cloud infrastructure providers, our projected growth in AI-driven revenues and margins, our ability to commercialize new technologies such as de novo antibody design and AI-designed GLP-1 therapeutics, future demand for our platform capabilities, ongoing strategic initiatives including business realignment and divestitures, and our ability to drive sustainable profitability. Article content The Company uses certain non-IFRS financial measures as supplemental indicators of its financial and operating performance. These non-IFRS financial measures are adjusted EBITDA and adjusted operating expenses. The Company believes these supplementary financial measures reflect the Company's ongoing business in a manner that allows for meaningful period-to-period comparisons and analysis of trends in its business. These non-IFRS measures do not have any standardized meaning prescribed under IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. Article content The Company defines adjusted EBITDA as operating earnings before taxes, amortization, depreciation, accretion, asset impairment charges, foreign exchange gain/loss, interest and other income and share-based compensation. Adjusted EBITDA is presented on a basis consistent with the Company's internal management reports. The Company discloses adjusted EBITDA to capture the profitability of its business before the impact of items not considered in management's evaluation of operating unit performance. The most directly comparable IFRS measure to adjusted EBITDA is net loss. Article content These statements are based on management's current expectations and assumptions and involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied. These include, but are not limited to: execution risks related to strategic partnerships, delays or failures in technology development or commercialization, market adoption of AI-based drug discovery tools, fluctuations in financial markets, general economic conditions, and risks related to funding requirements and liquidity. Article content The Company cautions readers not to place undue reliance on these forward-looking statements. All such statements are made as of the date of this release and, unless required by law, the Company assumes no obligation to update or revise them to reflect new events or circumstances. Article content IMMUNOPRECISE ANTIBODIES LTD. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (Unaudited – Expressed in Canadian dollars) (in thousands) April 30, 2025 $ April 30, 2024 $ ASSETS Current assets Cash 10,665 3,459 Amounts receivable, net 4,115 3,790 Tax receivable 143 414 Inventory 2,095 2,139 Unbilled revenue 548 277 Prepaid expenses 1,188 1,408 18,754 11,487 Restricted cash 126 86 Deposit on equipment 502 475 Property and equipment 15,762 16,696 Intangible assets 1,067 23,557 Goodwill 8,230 7,687 Total assets 44,441 59,988 LIABILITIES Current liabilities Accounts payable and accrued liabilities 5,283 4,372 Deferred revenue 1,090 1,352 Tax payable 475 553 Leases 1,850 1,563 Deferred acquisition payments 314 284 9,012 8,124 Leases 11,553 12,118 Deferred income tax liability 250 4,068 Total liabilities 20,815 24,310 SHAREHOLDERS' EQUITY Share capital 136,371 119,773 Contributed surplus 12,833 12,388 Accumulated other comprehensive income 3,216 2,077 Accumulated deficit (128,794 ) (98,560 ) 23,626 35,678 Total liabilities and shareholders' equity 44,441 59,988 Article content IMMUNOPRECISE ANTIBODIES LTD. CONSOLIDATED STATEMENTS OF CASH FLOWS For the year ended April 30, 2025 and 2024 (Unaudited – Expressed in Canadian dollars) (in thousands) 2025 $ 2024 $ Operating activities: Net loss for the period (30,234 ) (26,115 ) Items not affecting cash: Accretion 10 19 Amortization and depreciation 5,119 5,735 Asset impairment 21,184 15,031 Deferred income taxes (3,935 ) (1,773 ) Foreign exchange 622 15 Gain on investment (7 ) (2 ) Share-based expense 445 1,535 (6,796 ) (5,555 ) Changes in non-cash working capital related to operations: Amounts receivable (298 ) (601 ) Inventory 138 (102 ) Unbilled revenue (248 ) 360 Prepaid expenses 261 624 Accounts payable and accrued liabilities 827 983 Sales and income taxes payable and receivable 8 733 Deferred revenue (302 ) 374 Net cash used in operating activities (6,410 ) (3,184 ) Investing activities: Purchase of equipment (799 ) (1,397 ) Security deposit on leases — (141 ) Deferred acquisition payments — (146 ) Sale of QVQ Holdings BV shares — 121 Net cash used in investing activities (799 ) (1,563 ) Financing activities: Proceeds from share issuance, net of transaction costs 12,228 2,360 Proceeds from debenture 4,242 — Repayment of leases (1,577 ) (1,339 ) Net cash provided by financing activities 14,893 1,021 Increase (decrease) in cash during the period 7,684 (3,726 ) Foreign exchange (438 ) (1,095 ) Cash – beginning of the period 3,545 8,366 Cash – end of the period 10,791 3,545 Cash is comprised of: Cash 10,665 3,459 Restricted cash 126 86 10,791 3,545 Cash paid for interest — — Cash paid for income tax 2 — Article content Article content Article content Article content Article content Contacts Article content Article content Article content
