Allegheny Health Network warns most Signa customers could lose in-network coverage unless agreement is reached
In a letter sent to patients, Allegheny Health Networks said it has been "unable to reach a fair and mutually acceptable agreement" with Cigna after several months of negotiation.
"We understand how disconcerting and stressful this news may be for you, and please know that it is our sincerest hope that we will reach a new agreement with Cigna before June 30 that will enable you to continue receiving the health care services you need at AHN over the long term," AHN's letter read.
If the contract does end, the health system said it's "committed" to making sure there are no care disruptions for Cigna members who are actively in treatment. AHN also said it will try to ensure that transitions to new physicians, if necessary, are "seamless."
"In the unfortunate event that AHN's contract with Cigna does come to an end, however, our highest priority will be minimizing the inconvenience, stress, and burden of this development on you and other Cigna members," the letter says.
AHN encourages anyone with questions to contact the Cigna customer service line on the back of their card or call 1-800-997-1654.
In 2023, about 20,000 Cigna customers were at risk of losing in-network coverage at Allegheny Health Network facilities, but the two did reach an agreement.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Forbes
2 minutes ago
- Forbes
The Evolution Of EAPs: From Crisis Hotline To Proactive Health Engine
Stephen Sokoler, founder & CEO of Journey. Workplace mental health support has traveled a long arc since the 1930s, when early employee assistance programs (EAPs) emerged—primarily to address occupational alcoholism and acute crises. Over subsequent decades, programs added short‑term counseling and referral services but largely remained reactive, activated only after employees were already in distress. Engagement remained stubbornly low; traditional EAP utilization (registration required) in large U.S. employers has hovered in the single digits. Phase 2: Digital EAPs Improved Access, But Mostly After The Fact Around the mid‑2010s, a new wave of digital EAP and tech‑enabled mental health vendors streamlined access to therapists through apps, curated networks and rapid scheduling. That was a real advance. Employees no longer had to navigate phone trees or outdated provider directories, time‑to‑appointment shrank dramatically and venture investment into mental health tech surged (mental health tech funding topped roughly $5.5 billion in 2021). Yet the model still centered on therapy after symptoms appeared. And convenience carried a cost. In its independent 2025 assessment of virtual solutions for depression and anxiety, the Peterson Health Technology Institute (PHTI) reported that many blended‑care offerings—those that combine per‑member platform fees with broad access to therapy—increased total health spending, and clinical gains did not consistently offset costs. PHTI advised purchasers to steer employees with mild symptoms toward lower‑cost digital resources and reserve higher‑touch therapy for elevated need. According to SHRM, the average engagement with digital mental health platforms is very low (registration required), while, according to another source, typical pricing is cited in the $10 to $14 per employee, per month (PEPM) range, plus downstream clinical fees. Digital EAPs were therefore a needed step forward on access, but they didn't fully solve three persistent problems: • Reactivity: Help still depends on an employee raising a hand. • Cost Escalation: High unit pricing and therapy default pushed total spend upward. • Low Reach: Even improved models typically engage a minority of the workforce. Phase 3: Proactive, Preventive, People‑First A third wave is emerging: Proactive EAPs designed to support everyday mental fitness, surface risk early and right‑size care before issues snowball into crisis, absenteeism, disability or turnover. Some established players—Headspace, TELUS Health, Virgin Pulse, Workplace Options and others—have added proactive elements such as well-being apps, manager dashboards or push content. But in most cases, these features sit on top of a traditional EAP chassis, and engagement remains modest. A newer group of vendors (my own company among them) is attempting to build proactivity into the core operating and economic model: frequent outbound touch points, behavioral signal monitoring, stepped‑care routing and accountability for measurable engagement. What 'Proactive' Looks Like In Real Life Monday, 8:05 a.m.: Rosa, a line supervisor, badge‑scans into her plant. A breakroom screen pushes a one-tap mood check. 8:07 a.m.: She taps 'Stressed.' An immediate audio micro‑practice lands on her phone. 8:10 a.m.: Because her stress score has trended up three days running, the system offers a same‑day video session with a bilingual coach. 3:00 p.m.: Coach confirms early burnout and escalates Rosa to a therapist before she misses work or lands in urgent care. None of that required Rosa to 'call the EAP.' Here's why a proactive model is gaining momentum: • Earlier Intervention, Better Triage: Continuous light‑touch screening and self‑guided check‑ins can surface rising stress, sleep disruption, caregiving strain or trauma exposure long before acute depression shows up in claims data, enabling stepped care (self‑guided → coaching → therapy) aligned with the PHTI recommendation to match intensity to need. • Improved Cost Efficiency: When scalable tools like micro‑lessons, group sessions and asynchronous content carry much of the preventive load, costly one‑to‑one therapy can be preserved for higher‑acuity cases. Employers avoid 'therapy for everyone' cost curves without abandoning access. • Embedded In The Workday: Integrations with collaboration platforms (Teams, Slack), calendaring tools, learning portals and even badge or kiosk systems reduce stigma and friction. Support shows up where work happens instead of in a standalone benefit silo. • Aligned With HR And Business Priorities: Modern platforms increasingly surface population‑level insights—hot spots by location or job type, utilization patterns across demographic groups, EAP‑to‑medical handoffs—that help Benefits, DEI and People Analytics leaders steer strategy. Choosing What Comes Next If you put a digital EAP in place over the last few years, you were ahead of the curve—you tackled the access problem. The question now: How do you reach far more of your people earlier without breaking the budget? When evaluating next‑generation mental health partners, consider asking them about the following: • Engagement Reality: What percent of the eligible population interacts with any resource quarterly? Annually? How is that measured? • Acuity Match: How do you steer mild, moderate and high‑risk users to different levels of care? Show the algorithm. • Cost Transparency: What's the full cost stack (platform, session fees, add‑ons)? Model low, base and high utilization scenarios. • Data And Outcomes: Can you correlate participation with improvements in validated scales (e.g., PHQ‑9, GAD‑7), absenteeism or retention? • Workflow Integration: Where will employees actually see or feel the program—email, Teams, text, kiosk, manager prompts? From Hotlines To Help Desks To Health Engines Mental health at work shouldn't switch on only after things go wrong. Like stretching before lifting or hydrating before a marathon, care works best when it's part of the daily environment. We've moved from hotlines (call in crisis) to help desks (click to schedule) to emerging health engines (care before crisis) that engage continuously, detect early and direct the right level of support at the right time. The next era of EAPs will belong to employers and partners who make that proactive shift. Forbes Business Council is the foremost growth and networking organization for business owners and leaders. Do I qualify?
Yahoo
30 minutes ago
- Yahoo
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 $12.89 FDA approved Lynozyfic™ (linvoseltamab) for relapsed or refractory multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria (CSU) FDA accepted for priority review Libtayo® sBLA for adjuvant cutaneous squamous cell carcinoma (CSCC) In-licensed rights to late-stage dual GLP-1/GIP receptor agonist; reported interim 26-week data from Phase 2 COURAGE trial in obesity TARRYTOWN, N.Y., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the second quarter of 2025 and provided a business update. "Regeneron had a strong quarter, marked by significant growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo along with multiple regulatory approvals," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We have made significant progress in our oncology portfolio, including FDA approval for Lynozyfic for relapsed or refractory multiple myeloma, exciting emerging data from the lead-in cohorts of our pivotal programs in myeloma and lymphoma, as well as positive pivotal data supporting a potential upcoming FDA approval for Libtayo in adjuvant CSCC. Dupixent continues to be the world-leading treatment for diseases driven by type 2 inflammation, adding recent FDA approvals for bullous pemphigoid and chronic spontaneous urticaria, the seventh and eighth distinct indications for this important medicine. We are confident in the near- and long-term potential of our diverse pipeline and look forward to additional data and regulatory milestones later this year."($ 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."Key Pipeline ProgressRegeneron 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 61st 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 $155 million. Second Quarter 2025 Financial Results($ 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 $69 million for the second quarter of 2025 and 2024, respectively. GAAP % Change Non-GAAP(a) % Change ($ 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 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 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, 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 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 ( Non-GAAP Financial Measures 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. Contact Information: Ryan Crowe Christina Chan Investor Relations Corporate Affairs 914-847-8790 914-847-8827 TABLE 1 REGENERON PHARMACEUTICALS, CONSOLIDATED BALANCE SHEETS (Unaudited) June 30, December 31, 2025 2024 Assets: Cash and marketable securities $ 17,527.8 $ 17,912.6 Accounts receivable, net 5,610.0 6,211.9 Inventories 3,205.6 3,087.3 Property, plant, and equipment, net 4,840.7 4,599.7 Intangible assets, net 1,351.7 1,148.6 Deferred tax assets 3,572.2 3,314.1 Other assets 2,111.2 1,485.2 Total assets $ 38,219.2 $ 37,759.4 Liabilities and stockholders' equity: Accounts payable, accrued expenses, and other liabilities $ 4,887.0 $ 4,888.0 Finance lease liabilities 720.0 720.0 Deferred revenue 688.2 813.4 Long-term debt 1,985.1 1,984.4 Stockholders' equity 29,938.9 29,353.6 Total liabilities and stockholders' equity $ 38,219.2 $ 37,759.4 TABLE 2 REGENERON PHARMACEUTICALS, CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) 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 REGENERON PHARMACEUTICALS, OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) 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) 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, REVENUE (Unaudited) 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 REGENERON PHARMACEUTICALS, PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) 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.
Medscape
an hour ago
- Medscape
Nutrition Assistance Programs Combat Cognitive Decline
Nutrition assistance programs do more than fighting hunger. They also may help guard against age-related cognitive decline. Researchers found that people who participated in the US Supplemental Nutrition Assistance Program (SNAP) had slower cognitive decline over 10 years than peers who did not participate in the program. 'The chief policy implication of our study is that nutrition assistance programs like SNAP are not just anti-hunger tools — they are also public health tools that may help protect cognitive function and promote healthy aging,' lead author Linlin Da, MPH, PhD candidate, University of Georgia College of Public Health, Athens, Georgia, told Medscape Medical News . The study was presented on July 30 at the Alzheimer's Association International Conference (AAIC) 2025. Healthy Food, Healthy Brain Using the nationally representative Health and Retirement Study, researchers analyzed a racially and ethnically representative group of people aged 50 years or older. They compared 1131 individuals (mean age, 63 years) who were enrolled in SNAP in 2010 to 1216 individuals (mean age, 66 years) who were eligible for SNAP but did not participate in the program. 'Our study focused on SNAP — a real-world, policy-level intervention — rather than just individual food choices,' Da noted. As part of the study, memory and executive function were assessed every 2 years between 2010 and 2020 via telephone or web-based interviews. Individuals with an initial cognition summary score indicating cognitive impairment or dementia were excluded from the analysis. The researchers found that SNAP participants had a 0.10% slower decline in overall cognitive function ( P < .001 ), or 2-3 additional years of cognitive health over the 10-year period. 'For someone starting at a healthy cognitive score, this slower decline could delay reaching the threshold for mild cognitive impairment by nearly a decade,' Da noted in a conference statement. SNAP participants also had a slower decline in memory ( P < .001 ) and executive function ( P = .004 ) than peers not enrolled in SNAP. 'Our study is one of the first long-term, nationally representative studies to show that participation in a federal nutrition assistance program like SNAP is associated with slower cognitive decline in older adults,' Da told Medscape Medical News . Da said there are several biological and social mechanisms that may explain how SNAP participation slows cognitive decline, including improved nutrition. 'SNAP increases access to nutrient-dense foods that support brain health — such as fruits, vegetables, whole grains, and lean proteins. Better nutrition is linked to reduced inflammation, improved vascular health, and preservation of cognitive function over time,' Da explained. Reduced food insecurity and stress is another possibility. 'Chronic food insecurity is a significant source of psychological stress, which can negatively impact brain function. SNAP helps alleviate financial and emotional strain, leading to lower levels of chronic stress and potentially reducing harmful stress-related effects on memory and executive function,' Da said. 'We hope healthcare providers will see that potentially delaying cognitive impairment is another reason to help their patients-in-need secure access to food assistance,' co-author Suhang Song, PhD, assistant professor, Department of Health Policy and Management, University of Georgia College of Public Health, added in a conference statement. Equity Gaps While all racial and ethnic groups benefitted from SNAP participation, the protective effects on cognitive decline were smaller among non-Hispanic Black and Hispanic older adults compared with non-Hispanic White participants. There were 'racial and ethnic disparities in the cognitive benefits of SNAP, which points to important equity gaps in how nutrition policies may impact different populations,' Da said. 'We guess, even with SNAP, living in food deserts or areas with fewer healthy food options may limit the quality of nutrition people can access. This can especially affect Black and Hispanic communities, where structural barriers to healthy eating persist,' Da said. Commenting on this study for Medscape Medical News , Courtney Kloske, PhD, director of Scientific Engagement for the Alzheimer's Association, said it 'highlights the importance of nutritious foods and the impact that can have on the brain.' Maria Carrillo, PhD, chief science officer and medical affairs lead, Alzheimer's Association, noted that food insecurity can negatively affect cognitive function, and this is one of the first long-term studies to show that food assistance programs can positively impact cognition. 'Simple, everyday actions can make a difference in brain health and may even lower the risk of Alzheimer's disease and dementia. The Alzheimer's Association is committed to helping all people build these habits into their daily lives, including eating right, one of our 10 Healthy Habits for Your Brain,' Carrillo said in a statement.
