Regeneron Pharmaceuticals, Inc. (REGN) Earnings

Management highlights

### Core Business Performance - Regeneron delivered its second consecutive quarter of double-digit top and bottom-line growth, with 17% YoY total revenue growth and 11% YoY non-GAAP diluted EPS growth - Dupixent, ILEA-HD, and Libtayo all set all-time quarterly net sales records, with strong momentum heading into H2 2026 - Over 1.5 million patients are actively treated with Dupixent globally across 9 FDA-approved indications, and ILEA/ILEA-HD have exceeded 100 million total doses administered since 2011 ### Pipeline Progress - Simdiceran (C5 siRNA for generalized myasthenia gravis [GMG]) has accepted regulatory submissions at the FDA (PDUFA date November 2026) and EMA (decision expected H2 2027); registrational data for the simdiceran + pozelmab combination for paroxysmal nocturnal hemoglobinuria (PNH) is expected Q4 2026 - First-in-human trial for a long-acting IL-13 antibody (a Dupixent follow-on) has dosed initial healthy volunteers, with atopic dermatitis patient dosing planned for Q3 2026; next-generation Dupixent (SupiDupi) is expected to be clinic-ready by early 2027 - Positive early data for linazific (BCMAxCD3 bispecific) in systemic light chain amyloidosis: 100% of patients achieved complete hematologic response at the highest tested dose, with the registrational Phase 2 portion ongoing; pivotal trial data is expected 2027-2028 - The Factor XI anticoagulation program remains on track to initiate all remaining Phase 3 studies in 2026, with initial data expected H1 2027 - Olareptatide (dual GLP-1/GIP agonist for obesity) is on track to initiate Phase 3 studies in H2 2026, with top-line Phase 3 data from China to be presented October 2026; the combination of olareptatide + Praluent (PCSK9 antibody) continues to advance, with 52-week data to be presented in October 2026 - An FDA decision for garetosimab (for fibrodysplasia ossificans progressiva [FOP]) is expected August 2026; if approved, it will be the first ever treatment for FOP - Early promising data for Regeneron-developed Ebola antibodies shows prevention of mortality in non-human primates even after symptom onset, with discussions ongoing with global health authorities to support the ongoing DRC outbreak ### Capital Allocation - The company's core priority remains investing in internal R&D, but management is not averse to M&A, only to overpaying for transactions; Regeneron is actively evaluating a wide range of external business development opportunities that align with its core expertise - In H1 2026, Regeneron deployed $2.5 billion to share repurchases, business development, and dividends, repurchasing $2 billion of shares total ($1.2 billion in Q2 alone), reducing outstanding shares by 2.4 million; $2.5 billion of repurchase authorization remains as of Q2 end ### Collaboration Update - The 20-year collaboration with Sanofi has been one of the most productive in biopharma history, and the companies have held productive early discussions to expand the collaboration to include several Dupixent follow-on programs

Guidance

- With the full repayment of the Sanofi development balance completed in Q2 2026, Sanofi collaboration revenue will step up in Q3 2026 to reflect Regeneron's full share of collaboration profits - For H2 2026: Dupixent global YoY net sales growth is expected to remain strong but moderate relative to H1 2026, due to annualizing recent indication launches and tougher prior-year comparisons; ILEA-HD is expected to deliver sequential quarterly demand growth in the low to mid-teens in Q3 and Q4 2026; ILEA is expected to see sequential quarterly demand declines in the low to mid-teens due to conversion and competition; Libtayo growth is expected to continue in H2 2026 - Approval of the ILEA-HD pre-filled syringe is targeted by the end of 2026 - Multiple Phase 3 trial initiations are expected in the obesity portfolio in H2 2026

Segment performance

1. Immunology & Inflammation: Dupixent global net sales were $6.0 billion, up 38% year-over-year (YoY) on a constant currency basis, contributing 46% of total Q2 2026 revenue. U.S. sales grew 42% YoY to $4.6 billion, driven by growth across blockbuster indications and uptake in new indications. 2. Retinal: Combined U.S. net sales of ILEA and ILEA-HD reached $1.008 billion, up 7% quarter-over-quarter (QoQ), contributing 23.4% of total Q2 2026 revenue. ILEA-HD U.S. net sales were $596 million, up 52% YoY and 27% QoQ, and now accounts for 60% of U.S. retinal franchise net sales (up from 34% YoY). ILEA U.S. net sales were $412 million, down 45% YoY due to conversion to ILEA-HD and competitive pressure. ILEA/ILEA-HD net sales outside the U.S. were $667 million, inclusive of $366 million of ILEA-HD sales. 3. Oncology: Libtayo global net sales were $489 million, up 29% YoY on a constant currency basis, contributing 11.4% of total Q2 2026 revenue. U.S. sales grew 38% YoY to $343 million, with Libtayo capturing 20% of new-to-brand prescriptions for first-line non-small cell lung cancer in the U.S. Linazepic, a newly launched oncology asset, reported modest early commercial growth, with positive physician feedback. 4. Rare Disease: Evkeeza (for homozygous familial hypercholesterolemia) delivered net sales of $53 million, up 29% YoY. Otarmony, the first gene therapy for genetic childhood hearing loss, has dosed its first patients, with early launch activities ongoing. Sanofi collaboration revenue reached an all-time high of $2.2 billion, contributing 51.2% of total Q2 2026 revenue, with $2 billion of that coming from Regeneron's share of collaboration profits, up 59% YoY. Total Q2 2026 revenue was $8.5 billion, growing 17% YoY overall.

Risks & headwinds

- ILEA faces increasing competitive pressure, including the upcoming launch of multiple aflibercept 2 mg biosimilars, which will drive continued sales declines - Early and mid-stage pipeline candidates carry inherent clinical development risk; not all programs will successfully reach approval - A temporary bulk manufacturing interruption at the Limerick, Ireland facility negatively impacted GAAP gross margin in Q2 2026, though production resumed normal levels by the end of the quarter - Drug pricing regulation and changes to payer coverage/reimbursement policies could negatively impact net sales and margins - Ongoing negotiations to expand the Sanofi collaboration may not result in a finalized agreement on acceptable terms for both parties

Analyst Q&A

• Q: With the Sanofi development balance repaid and growing excess cash, how does management approach M&A after prior comments about being cautious on large deals? /

  A: Management clarified it is not averse to M&A, only to overpaying for transactions that do not create long-term shareholder value. Regeneron tilts more capital toward high-return internal R&D in line with its core strengths, but actively evaluates all external opportunities of any size, and will pursue deals that are strategically aligned and reasonably priced.

• Q: Can you share updates on expanding the Sanofi collaboration for Dupixent follow-on assets, and how would you accelerate development of these assets? /

  A: The 20-year Sanofi collaboration is one of the most productive in industry history, and the companies have held productive early discussions between leadership about adding follow-on Dupixent portfolio assets (including the long-acting IL-13 antibody and next-generation Dupixent) to the alliance. Regeneron has unmatched experience developing and commercializing I&I assets in this space, and any expanded partnership would leverage that shared existing expertise to speed development.

• Q: What is the status of the ILEA-HD pre-filled syringe FDA review, and why are multiple contract manufacturers involved? /

  A: The FDA initially did not act by the prior expected Q2 2026 timeline, but the company has held productive recent discussions and clarified the approval path. Multiple (more than two) contract manufacturers are now engaged to provide backup manufacturing capacity, and management is leaving no stone unturned to secure approval by the end of 2026 or sooner. Management emphasized ILEA-HD is already performing extremely well even without this enhancement.

• Q: What differentiates Regeneron's siRNA MASH asset from approved therapies, especially given GLP-1 uptake in this category? /

  A: Unlike approved and pipeline agents that work indirectly to treat MASH (most often by reducing food intake), Regeneron's candidate is based on genetic discoveries from the Regeneron Genetics Center that directly target the causal mechanism of the disease. Management believes mimicking these naturally protective genetic mechanisms could lead to deeper, faster disease reversal than current indirect approaches, with data expected to be presented later in 2026.

• Q: What is your differentiation for simdiceran in GMG versus existing marketed therapies? /

  A: Simdiceran offers consistent, steady disease control via convenient quarterly subcutaneous injections, unlike existing FCRN therapies that require repeated cycling and are associated with recurring loss of efficacy over time. It also delivers best-in-class cross-study efficacy without requiring full complement inhibition, a potential long-term safety benefit that will be further validated via real-world evidence after approval. The company is actively preparing for a November 2026 launch.