November 2, 2026·38 min read
Regeneron (REGN), Financial Analysis
Insights derived from analysing SEC filings. Independent analysis, not a publication of the SEC.
Total revenues Q3 2026
$5.12bn
+36.3% year on year (Q3 2025 $3.75bn)
Total operating expenses Q3 2026
$3.07bn
+12.5% year on year (Q3 2025 $2.73bn)
Operating margin Q3 2026
40.0%
+12.7 pts year on year (Q3 2025 27.3%)
Key findings
- Sanofi revenue drove the quarter. Total revenues $5.12bn in Q3 2026, +36.3%; Sanofi collaboration revenue rose $1.11bn to $2.72bn, 81.3% of the $1.36bn increase. Operating margin 40.0% against 27.3%.
- Part of the Q3 growth comes from a completed repayment. Regeneron's Dupixent and Kevzara profit share was reduced by repayment of Sanofi funded development costs until the balance was repaid on 30 Jun 2026; Q3 2025 carried a $268.1m deduction, Q3 2026 none. With that amount added back to Q3 2025, growth is 27.2% (computed); 9M 2026 growth is 24.4%.
- Q4 2026 adds a $1.0bn up front payment. The 10-Q states that the $1.0bn up front payment received from Sanofi under the Sixth Amendment of 1 Oct 2026 will be recorded to collaboration revenue in Q4 2026; it equals 25.7% of Q4 2025 revenue of $3.88bn (computed). Up to $7.0bn of milestones may follow.
- Dupixent sales $6.54bn, +34.7%. Regeneron's profit share was 37.9% of Dupixent and Kevzara sales against 29.0%. Rival biologics grew from smaller bases: Lilly Ebglyss $202m (+59.1%), AstraZeneca Tezspire $429m (+50.0%).
- EYLEA HD replaces EYLEA. U.S. EYLEA HD $698.8m (+62.3%), 63.6% of U.S. franchise sales; EYLEA $399.7m ((41.3%)) against biosimilars; U.S. franchise (1.1%); Bayer collaboration revenue (22.6%). Libtayo $550m (+50.6%).
- Shares at $943.66 on 2 Nov 2026, +13.3% on results day, 20.8x TTM diluted EPS and 17.1x TTM non GAAP EPS; net cash $16.2bn. Three year scenarios: base $1,008, best $1,654, worst $427.
Figures are read from the Forms 10-K for FY2022, FY2023 and FY2025 with their prior year comparatives back to FY2021, the Forms 10-Q for Q1 to Q3 2026, the Forms 8-K with all their exhibits, incl. the quarterly earnings releases (Ex 99.1) with the CFO commentary they contain, the J.P. Morgan Healthcare Conference release (Ex 99.1), the CEO and CSO performance share unit agreements (Ex 10.1, 10.2) and their supplemental information (Ex 99.1), the Sixth Amendment to the Sanofi antibody collaboration (Ex 10.4 to the Q3 2026 Form 10-Q), the 2026 proxy statement, the Form 8-K Item 5.07 vote results, Schedules 13G and Forms 4 on the record for central index key 872589, and the filings of 9 other companies used in chapters 2 to 4 and 7. Regeneron files no separate CFO commentary exhibit: CFO commentary comes from the earnings releases and from reports of the Q1 to Q3 2026 calls; no full Q3 2026 call transcript was available on 2 Nov 2026. Accession numbers for every filing used appear in the Sources appendix. The market price is a trade of 2 November 2026 during the session.
1 Revenue & Business Model
- Storyline: revenue moves from EYLEA product sales to the Sanofi profit share. Collaboration revenue was 55.2% of TTM revenue; Sanofi alone 53.2% of Q3 2026 revenue against 43.1% a year earlier. Chapters 2 to 4 cover the three revenue drivers: Dupixent and the Sanofi alliance, the EYLEA franchise, and Libtayo and oncology.
- One segment, three revenue types. Net product sales ($6.31bn in FY2025, 44.0%) are U.S. EYLEA HD and EYLEA, global Libtayo, U.S. Praluent and smaller products; collaboration revenue ($7.33bn, 51.1%) is Regeneron's share of profits on sales recorded by Sanofi (Dupixent, Kevzara) and Bayer (EYLEA outside the U.S.); other revenue ($702.6m) is mainly royalties.
- Profit split: Dupixent and Kevzara U.S. profits 50/50, outside the U.S. 35% rising to 45% for Regeneron; EYLEA outside the U.S. 50/50 with Bayer. Two customers took 50% and 27% of gross product revenue in FY2025 (10-K).
- Revenue FY2021 $16.07bn to FY2025 $14.34bn, a (2.8)% CAGR including $6.19bn of COVID 19 antibody revenue in FY2021; 9.8% excluding it. TTM Q3 2026 $16.90bn.
- Net sales of Regeneron discovered products were about $25.7bn in 9M 2026, recorded by Regeneron or its partners: Dupixent $17.4bn, EYLEA HD and EYLEA $5.1bn, Libtayo $1.5bn (Q3 2026 release, Table 5). Regeneron records only its product sales and profit shares as revenue.
- 15,410 employees at 31 Dec 2025; about 50 product candidates in clinical development (Q3 2026 release).
Table 1.1 Revenue by product and partner ($bn)
| Line | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 | 9M 2025 | 9M 2026 | 9M change (%) |
|---|---|---|---|---|---|---|---|---|
| EYLEA HD (U.S.) | 0.00 | 0.00 | 0.17 | 1.20 | 1.64 | 1.13 | 1.76 | 56.0 |
| EYLEA (U.S.) | 5.79 | 6.26 | 5.72 | 4.77 | 2.75 | 2.17 | 1.29 | (40.8) |
| Libtayo (global) | 0.31 | 0.45 | 0.86 | 1.22 | 1.45 | 1.03 | 1.48 | 43.9 |
| Praluent (U.S.) | 0.17 | 0.13 | 0.18 | 0.24 | 0.26 | 0.19 | 0.22 | 17.1 |
| Other products | 0.02 | 0.05 | 0.15 | 0.20 | 0.21 | 0.12 | 0.23 | 101.6 |
| REGEN COV (U.S., COVID 19 antibody) | 5.83 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | n/a |
| Sanofi collaboration | 1.90 | 2.83 | 3.80 | 4.53 | 5.88 | 4.24 | 6.50 | 53.2 |
| Bayer collaboration | 1.41 | 1.43 | 1.49 | 1.50 | 1.42 | 1.10 | 0.83 | (24.8) |
| Roche collaboration (Ronapreve) | 0.36 | 0.63 | 0.21 | 0.00 | 0.00 | 0.00 | 0.00 | n/a |
| Other collaboration | 0.00 | 0.03 | 0.01 | 0.03 | 0.02 | 0.01 | 0.02 | 68.0 |
| Other revenue | 0.28 | 0.37 | 0.54 | 0.52 | 0.70 | 0.46 | 0.67 | 45.4 |
| Total revenues | 16.07 | 12.17 | 13.12 | 14.20 | 14.34 | 10.46 | 13.01 | 24.4 |
EYLEA HD, EYLEA and Praluent net product sales are U.S. only; Libtayo global from Jul 2022. Sanofi collaboration revenue is net of development balance repayment until Q2 2026. Other revenue is mainly royalties and profit shares.
Table 1.2 Revenue by type, last five quarters
| Line | Q3 2025 | Q4 2025 | Q1 2026 | Q2 2026 | Q3 2026 |
|---|---|---|---|---|---|
| Net product sales ($bn) | 1.59 | 1.67 | 1.53 | 1.64 | 1.81 |
| Collaboration revenue ($bn) | 1.97 | 1.97 | 1.90 | 2.46 | 3.00 |
| Other revenue ($bn) | 0.20 | 0.24 | 0.17 | 0.19 | 0.31 |
| Total revenues ($bn) | 3.75 | 3.88 | 3.61 | 4.29 | 5.12 |
| Collaboration revenue share (%) | 52.4 | 50.7 | 52.7 | 57.2 | 58.7 |
Table 1.3 Net sales recorded by Regeneron or partners, last five quarters
| Product and region | Q3 2025 | Q4 2025 | Q1 2026 | Q2 2026 | Q3 2026 |
|---|---|---|---|---|---|
| Dupixent U.S. ($bn) | 3.62 | 3.73 | 3.56 | 4.56 | 5.06 |
| Dupixent rest of world ($bn) | 1.24 | 1.21 | 1.32 | 1.44 | 1.48 |
| EYLEA HD and EYLEA U.S. ($bn) | 1.11 | 1.08 | 0.94 | 1.01 | 1.10 |
| EYLEA HD and EYLEA rest of world (Bayer) ($bn) | 0.85 | 0.82 | 0.73 | 0.67 | 0.64 |
| Libtayo U.S. ($bn) | 0.22 | 0.29 | 0.29 | 0.34 | 0.40 |
| Libtayo rest of world ($bn) | 0.15 | 0.14 | 0.15 | 0.15 | 0.15 |
Dupixent sales and EYLEA sales outside the U.S. are recorded by Sanofi and Bayer; Regeneron books a share of profits on them.
2 Dupixent & Sanofi: Full Profit Share From Q3 2026
- Sanofi collaboration revenue $2.72bn in Q3 2026, +68.5%, 53.2% of total revenues. It consists of Regeneron's share of Dupixent and Kevzara profits ($2.57bn, +76.9%) plus manufacturing reimbursement.
- Dupixent global sales $6.54bn, +34.7%: U.S. $5.06bn (+39.9%), rest of world $1.48bn (+19.2%); 9M 2026 $17.4bn. Kevzara $255.6m (+66.0%).
- Effect of the completed repayment, as filed: until 30 Jun 2026 Regeneron repaid Sanofi funded development costs out of its profit share ($644.8m in 9M 2025, $530.0m in 9M 2026; $595m outstanding at 31 Dec 2025). Q3 2025 carried $268.1m, Q3 2026 nothing. The profit share rose to 37.9% of combined sales from 29.0%; adding the $268.1m back to Q3 2025, total revenue growth is 27.2% against 36.3% reported (computed).
- Effect of the up front payment, as filed: the $1.0bn up front payment received under the Sixth Amendment of 1 Oct 2026 will be recorded to collaboration revenue in Q4 2026, equal to 25.7% of Q4 2025 total revenues (computed); in Q4 2025 the development balance was still being repaid ($595m outstanding at 31 Dec 2025). Q4 2026 growth therefore includes the up front payment, and comparisons from Q3 2027 on no longer include the repayment effect.
How immunology biologics are changing
- Dupixent sales $6.54bn in Q3 2026 against AbbVie Rinvoq $2.71bn; over 1.5m patients treated by mid 2026 (Q2 2026 call); new FDA approvals in allergic fungal rhinosinusitis and young children with CSU in Q1 2026.
- Newer biologics grow from smaller bases: Lilly Ebglyss (IL 13) $202m (+59.1%), AstraZeneca Tezspire $429m (+50.0%), Rinvoq +23.9%, while Novartis Xolair fell 25.0% on biosimilar entry.
- Long acting follow ons: the Sixth Amendment adds four long acting antibodies against IL 13, IL 4, IL 4R alpha and IL 4 x IL 13 (one in Phase 1, three to enter the clinic in 2027); Dupixent's U.S. composition of matter patent runs to Mar 2031.
Table 2.1 Dupixent against immunology competitors
| Company and product | Period | Sales | Growth (%) | Filed detail |
|---|---|---|---|---|
| Regeneron and Sanofi: Dupixent (IL 4R alpha) | Q3 2026 | $6.54bn | 34.7 | U.S. $5.06bn (+39.9%); rest of world $1.48bn (+19.2%) |
| Regeneron and Sanofi: Kevzara (IL 6R) | Q3 2026 | $256m | 66.0 | recorded by Sanofi; profits shared as for Dupixent |
| AbbVie: Rinvoq (JAK inhibitor) | Q3 2026 | $2.71bn | 23.9 | competes in atopic dermatitis |
| AstraZeneca: Tezspire (TSLP) | Q3 2026 | $429m | 50.0 | severe asthma; Fasenra $602m (+13%) |
| Amgen: Tezspire (Amgen share) | Q2 2026 | $486m | 42.0 | co developed with AstraZeneca |
| Eli Lilly: Ebglyss (IL 13) | Q3 2026 | $202m | 59.1 | atopic dermatitis; Q3 2025 $127m |
| Novartis: Xolair (anti IgE) | Q3 2026 | $331m | (25.0) | asthma, CSU and food allergy; biosimilar entry |
Dupixent and Kevzara sales are recorded by Sanofi. Amgen and AstraZeneca share Tezspire; Amgen had not filed Q3 2026 at the time of writing.
Table 2.2 Sanofi profit share, last five quarters
| Line | Q3 2025 | Q4 2025 | Q1 2026 | Q2 2026 | Q3 2026 |
|---|---|---|---|---|---|
| Dupixent global net sales ($bn) | 4.86 | 4.94 | 4.88 | 6.00 | 6.54 |
| Kevzara global net sales ($bn) | 0.15 | 0.15 | 0.14 | 0.21 | 0.26 |
| Regeneron share of antibody profits ($bn) | 1.46 | 1.49 | 1.45 | 2.03 | 2.57 |
| Share of Dupixent and Kevzara sales (%) | 29.0 | 29.2 | 28.9 | 32.8 | 37.9 |
| Sanofi collaboration revenue ($bn) | 1.62 | 1.64 | 1.61 | 2.17 | 2.72 |
| Sanofi collaboration revenue growth (%) | n/a | n/a | 35.7 | 50.6 | 68.5 |
Share of sales is Regeneron's share of antibody profits divided by Dupixent plus Kevzara global net sales. Profit shares to Q2 2026 are net of development balance repayment.
3 EYLEA HD & EYLEA: Conversion Against Biosimilars
- U.S. EYLEA HD $698.8m in Q3 2026, +62.3%, and EYLEA $399.7m, (41.3%); the U.S. franchise of $1.10bn was (1.1%). EYLEA HD was 63.6% of U.S. franchise sales against 38.8% a year earlier.
- Drivers (10-Q): EYLEA HD volume rose on demand, partly offset by a lower net selling price; EYLEA fell on biosimilar competition and switching to EYLEA HD. FY2025 U.S. EYLEA HD and EYLEA sales fell 27% to $4.38bn.
- Outside the U.S. (Bayer): EYLEA 8 mg and EYLEA sales $642.7m ((24.7%)); Regeneron's profit share $211.5m against $311.9m; Bayer collaboration revenue $266.8m ((22.6%)). Global EYLEA HD and EYLEA sales $1.74bn ((11.4%)).
- Next steps (10-Q and call): EYLEA HD pre filled syringe approval targeted by end of 2026 with several third party fillers; FDA approved dosing intervals up to five months in Q1 2026.
How the retinal market is changing
- Biosimilars of the 2 mg dose: U.S. regulatory exclusivity ended in May 2024; Amgen Pavblu, the only commercially available U.S. biosimilar in Q2 2026, sold $287m (+121.0%); a settlement keeps Samsung's biosimilar out of the U.S. until Jan 2027; Regeneron expects more launches.
- Higher dose, longer intervals: EYLEA HD dosing up to every five months competes with Roche's Vabysmo, the main branded rival; Roche does not file with the SEC, so no Vabysmo figure appears here.
- Outside the U.S.: Regeneron settled with Sam Chun Dang (Aug 2026) and Sandoz (Oct 2026); the EPO revoked one EYLEA patent in Apr 2026.
Table 3.1 EYLEA franchise against the biosimilar ($m unless stated)
| Company and product | Period | Sales | Growth (%) | Filed detail |
|---|---|---|---|---|
| Regeneron: EYLEA HD (U.S.) | Q3 2026 | $698.8m | 62.3 | 63.6% of U.S. EYLEA franchise sales (Q3 2025 38.8%) |
| Regeneron: EYLEA 2 mg (U.S.) | Q3 2026 | $399.7m | (41.3) | biosimilars and switching to EYLEA HD |
| Regeneron: U.S. EYLEA franchise | Q3 2026 | $1.10bn | (1.1) | EYLEA HD plus EYLEA |
| Bayer: EYLEA HD and EYLEA outside the U.S. | Q3 2026 | $642.7m | (24.7) | Regeneron profit share $211.5m against $311.9m |
| Amgen: Pavblu (aflibercept biosimilar) | Q2 2026 | $287m | 121.0 | only commercially available U.S. EYLEA biosimilar in Q2 2026 |
Amgen figures are Q2 2026; Amgen had not filed Q3 2026 at the time of writing. Bayer and Samsung Bioepis are not SEC registrants; sales outside the U.S. are from Regeneron's release.
4 Libtayo & Oncology: Adjuvant Use and New Launches
- Libtayo $550m in Q3 2026, +50.6%: U.S. $395.8m (+80.6%), rest of world $154.2m (+5.5%); 9M 2026 $1.48bn (+44%). Regeneron records Libtayo sales globally and pays royalties to Sanofi.
- Drivers: approval as the first immunotherapy for high risk adjuvant cutaneous squamous cell carcinoma in the U.S. and EU in Q4 2025 and in Japan in Aug 2026; 20% of new to brand first line NSCLC prescriptions in Q2 2026 (Q2 2026 call).
- New oncology products: Lynozyfic (BCMA x CD3) $19m in Q3 2026 after $17m in Q2; Ordspono (odronextamab) target action date Feb 2027 in DLBCL; a Libtayo dosing sBLA has a Mar 2027 date.
- Other products: Praluent (U.S.) $81.5m (+20.4%), against Amgen Repatha $953m (+37%) in Q2 2026; Evkeeza $55m; Pasatru approved for FOP in Aug 2026.
How the oncology market is changing
- PD 1 and PD L1 drugs move to subcutaneous dosing: Merck Keytruda incl. Qlex $8.60bn (+5.6%); Bristol Myers Squibb Opdivo $2.37bn, (6.2%), with subcutaneous Qvantig $334m (+398.5%); AstraZeneca Imfinzi $1.99bn (+24.0%).
- Bispecific antibodies in myeloma: J&J Tecvayli $312m (+76.6%) and Talvey $171m (+40.9%) against Regeneron's Lynozyfic at $19m.
- New mechanisms: Summit Therapeutics reported Phase 3 data for the PD 1 x VEGF bispecific ivonescimab in Sep 2026, with no product revenue.
Table 4.1 Libtayo and oncology products against competitors
| Company and product | Period | Sales | Growth (%) | Filed detail |
|---|---|---|---|---|
| Regeneron: Libtayo (PD 1) | Q3 2026 | $550m | 50.6 | U.S. $395.8m (+80.6%); rest of world $154.2m (+5.5%) |
| Regeneron: Lynozyfic (BCMA x CD3) | Q3 2026 | $19m | n/a | launched Q3 2025; Q2 2026 $17m |
| Merck: Keytruda incl. Keytruda Qlex (PD 1) | Q3 2026 | $8.60bn | 5.6 | subcutaneous Qlex ahead of the 2028 U.S. patent expiry |
| Bristol Myers Squibb: Opdivo (PD 1) | Q3 2026 | $2.37bn | (6.2) | subcutaneous Opdivo Qvantig $334m (+398.5%) |
| AstraZeneca: Imfinzi (PD L1) | Q3 2026 | $1.99bn | 24.0 | 9M 2026 $5.54bn (+28%) |
| Johnson & Johnson: Tecvayli (BCMA x CD3) | Sep 2026 quarter | $312m | 76.6 | multiple myeloma; Talvey $171m (+40.9%) |
Libtayo growth is computed from Regeneron's release in $m. J&J quarter ends 27 Sep 2026.
5 Financial Analysis & Ratios
- Operating margin 28.8% TTM against 24.9% in FY2025 and 55.7% in FY2021, when COVID 19 antibody sales lifted revenue; Q3 2026 40.0% against 27.3% after the Sanofi step up.
- Net income TTM $4.82bn, 28.5% of revenue, with other income of $869.0m; gains on securities fell to $60.3m in Q3 2026 from $577.7m, so net income rose +33.5% against operating income +99.5%.
- Cash flow TTM: operating cash flow $4.85bn, capital expenditure $1.02bn, free cash flow $3.83bn (22.6% of revenue). Receivables rose to $7.58bn from $5.74bn at FY2025.
- Balance sheet at 30 Sep 2026: cash and marketable securities $18.86bn; debt $2.71bn (senior notes due 2030 and 2050 and the $720m Tarrytown finance lease, now current); net cash $16.15bn.
- Capital returns 9M 2026: buybacks $2.36bn and dividends $290.3m; $2.16bn of the Apr 2026 $3.0bn authorization left; dividend $0.94 per quarter. Diluted shares 105.6m in Q3 2026 against 107.2m.
Table 5.1 Income statement, cash flow and balance sheet summary ($bn unless stated)
| Line item | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 | TTM Q3 2026 |
|---|---|---|---|---|---|---|
| Revenue | 16.1 | 12.2 | 13.1 | 14.2 | 14.3 | 16.9 |
| Gross profit | 13.6 | 10.6 | 11.3 | 12.2 | 12.2 | 14.5 |
| Research and development | 2.9 | 3.6 | 4.4 | 5.1 | 5.9 | 6.6 |
| Selling, general and administrative | 1.8 | 2.1 | 2.6 | 3.0 | 2.7 | 2.8 |
| Operating income | 8.9 | 4.7 | 4.0 | 4.0 | 3.6 | 4.9 |
| Net income | 8.1 | 4.3 | 4.0 | 4.4 | 4.5 | 4.8 |
| Diluted EPS ($) | 71.97 | 38.22 | 34.77 | 38.34 | 41.48 | 45.29 |
| Operating cash flow | 7.1 | 5.0 | 4.6 | 4.4 | 5.0 | 4.8 |
| Capital expenditure | (0.6) | (0.6) | (0.7) | (0.8) | (0.9) | (1.0) |
| Free cash flow | 6.5 | 4.4 | 3.9 | 3.7 | 4.1 | 3.8 |
| Stock based compensation | 0.6 | 0.7 | 0.9 | 1.0 | 1.0 | 1.0 |
| Cash and investments | 12.5 | 14.3 | 16.2 | 17.9 | 18.9 | 18.9 |
| Total debt | 2.7 | 2.7 | 2.7 | 2.7 | 2.7 | 2.7 |
| Total equity | 18.8 | 22.7 | 26.0 | 29.4 | 31.3 | 33.5 |
Gross profit is revenue less cost of goods sold and cost of collaboration and contract manufacturing; Regeneron reports only a gross margin on net product sales. Total debt is senior notes plus the finance lease. TTM equals Q4 2025 plus Q1 to Q3 2026.
Table 5.2 What changed, Q3 2026 against Q3 2025
| Metric | Q3 2025 | Q3 2026 | Change |
|---|---|---|---|
| Revenue ($bn) | 3.75 | 5.12 | 36.3% |
| Gross profit ($bn) | 3.23 | 4.54 | 40.5% |
| Operating income ($bn) | 1.03 | 2.05 | 99.5% |
| Net income ($bn) | 1.46 | 1.95 | 33.5% |
| Diluted EPS ($) | 13.62 | 18.45 | 35.5% |
| Operating cash flow ($bn) | 1.62 | 1.78 | 10.2% |
| Free cash flow ($bn) | 1.42 | 1.48 | 4.6% |
| Operating margin (%) | 27.3 | 40.0 | 12.7 pts |
| Net margin (%) | 38.9 | 38.1 | (0.8 pts) |
Table 5.3 Ratio analysis
| Ratio | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 | TTM Q3 2026 |
|---|---|---|---|---|---|---|
| Growth and margins | ||||||
| Revenue growth (%) | n/a | (24.3) | 7.8 | 8.3 | 1.0 | n/a |
| Gross margin (%) | 84.8 | 87.2 | 86.2 | 86.1 | 85.4 | 85.8 |
| Operating margin (%) | 55.7 | 38.9 | 30.9 | 28.1 | 24.9 | 28.8 |
| Net margin (%) | 50.2 | 35.6 | 30.1 | 31.1 | 31.4 | 28.5 |
| FCF margin (%) | 40.6 | 36.3 | 29.5 | 25.8 | 28.4 | 22.6 |
| Cost and investment intensity | ||||||
| R&D (%) revenue | 17.8 | 29.5 | 33.8 | 36.1 | 40.8 | 39.0 |
| SBC (%) revenue | 3.7 | 6.0 | 6.7 | 6.9 | 6.9 | 6.0 |
| Capex (%) revenue | 3.4 | 4.8 | 5.5 | 5.3 | 6.3 | 6.0 |
| Effective tax rate (%) | 13.4 | 10.7 | 5.9 | 7.7 | 13.9 | 15.3 |
| Returns | ||||||
| ROE (%) | 43.0 | 20.9 | 16.3 | 16.0 | 14.9 | 14.4 |
| ROA (%) | 31.7 | 15.9 | 12.7 | 12.5 | 11.5 | 10.8 |
| ROIC (%) | 86.7 | 38.4 | 30.6 | 26.0 | 20.4 | 23.8 |
| Asset turnover (x) | 0.63 | 0.42 | 0.40 | 0.38 | 0.35 | 0.38 |
| Liquidity and leverage | ||||||
| Current ratio (x) | 3.56 | 5.06 | 5.69 | 4.73 | 4.13 | 3.35 |
| Debt to equity (x) | 0.14 | 0.12 | 0.10 | 0.09 | 0.09 | 0.08 |
| Net cash ($bn) | 9.8 | 11.6 | 13.5 | 15.2 | 16.2 | 16.2 |
| Efficiency and cash quality | ||||||
| Days sales outstanding | 137 | 160 | 158 | 160 | 146 | 164 |
| Inventory days | 292 | 562 | 519 | 572 | 556 | 439 |
| FCF to net income (x) | 0.81 | 1.02 | 0.98 | 0.83 | 0.91 | 0.79 |
| Shareholder returns (%) FCF | 25 | 47 | 58 | 71 | 93 | 89 |
ROE and ROA use average balances for FY2022 to FY2025 and period end balances for FY2021 and TTM. Gross margin uses the constructed gross profit.
Table 5.4 Valuation snapshot at $943.66 per share, 2 Nov 2026
| Measure | Value |
|---|---|
| Market cap ($bn) | 97.6 |
| Enterprise value ($bn) | 81.4 |
| P/E (TTM) (x) | 20.8 |
| EV/Sales (TTM) (x) | 4.8 |
| EV/EBITDA (TTM) (x) | 15.1 |
| FCF yield (%) | 3.9 |
| Price/Book (x) | 2.9 |
Cost structure and profitability
- Total operating expenses $3.07bn in Q3 2026, +12.5%, against revenue +36.3%; costs fell to 60.0% of revenue from 72.7%.
- R&D 35.1% of Q3 2026 revenue against 39.3%; TTM 39.0%. FY2026 GAAP R&D guidance $6.600bn to $6.735bn against $5.85bn in FY2025, which included a $155m priority review voucher.
- Acquired IPR&D $250.4m in 9M 2026 ($101.9m, $127.0m and $21.5m by quarter), each pre announced in an Item 2.02 Form 8-K.
- Gross margin on net product sales 82% in Q3 2026 after 76% in Q1 2026, when the Limerick interruption added unabsorbed costs; COGS and COCM together were 11.2% of revenue.
- SG&A $677.8m, 13.2% of revenue; guidance lowered twice in 2026. Q4 2025 SG&A included about $60m of matching donations to Good Days, with up to $200m committed for 2026.
Table 5.5 Costs as % of revenue, last five quarters
| Line | Q3 2025 | Q4 2025 | Q1 2026 | Q2 2026 | Q3 2026 |
|---|---|---|---|---|---|
| Cost of goods sold (% of revenue) | 7.5 | 8.2 | 10.4 | 8.4 | 6.3 |
| Cost of collaboration and contract manufacturing (% of revenue) | 6.4 | 6.8 | 8.2 | 5.0 | 4.9 |
| Research and development (% of revenue) | 39.3 | 41.9 | 42.8 | 38.0 | 35.1 |
| Acquired IPR&D (% of revenue) | 2.2 | 0.5 | 2.8 | 3.0 | 0.4 |
| Selling, general and administrative (% of revenue) | 17.5 | 20.0 | 18.0 | 15.4 | 13.2 |
| Operating income (% of revenue) | 27.3 | 22.7 | 17.8 | 30.1 | 40.0 |
| Capital expenditure (% of revenue) | 5.4 | 6.4 | 6.4 | 5.6 | 5.9 |
| Gross margin on net product sales, as reported (%) | 82.3 | 81.0 | 75.7 | 78.0 | 82.2 |
| Effective tax rate (%) | 17.2 | 19.1 | 12.5 | 15.1 | 14.7 |
Table 5.6 Income from operations to net income ($bn)
| Line | Q3 2025 | Q3 2026 | 9M 2026 |
|---|---|---|---|
| Income from operations | 1.03 | 2.05 | 3.98 |
| Other income (expense), net | 0.76 | 0.25 | 0.69 |
| of which gains on securities | 0.58 | 0.06 | 0.15 |
| Interest expense | (0.02) | (0.01) | (0.03) |
| Income tax expense | (0.30) | (0.34) | (0.67) |
| Net income | 1.46 | 1.95 | 3.97 |
Gains on securities as stated in the 10-Q MD&A ($577.7m, $60.3m and $147.2m); they sit inside other income.
6 MD&A & Management Commentary
Q3 2026 results release, Form 10-Q and earnings call
- Q3 2026 (30 Oct 2026): total revenues $5.12bn (+36.3%); income from operations $2.05bn against $1.03bn; net income $1.95bn (+33.5%); diluted EPS $18.45 (+35.5%); non GAAP EPS $20.07 (+69.7%).
- Sanofi (10-Q): Regeneron's share of antibody profits $2.57bn on $6.80bn of Dupixent and Kevzara sales, 37.9% against 29.0%; Q3 2025 was reduced by $268.1m of development balance repayment, 9M 2026 by $530.0m (9M 2025 $644.8m).
- Up front payment (10-Q and release): the $1.0bn up front payment received from Sanofi under the Sixth Amendment will be recorded to collaboration revenue in Q4 2026; the company does not give revenue guidance, and its expense guidance excludes business development not yet completed.
- Costs: R&D $1.79bn (+21.7%), incl. clinical manufacturing $507.7m (+33%); SG&A $677.8m (+3.0%); gross margin on net product sales 82%, 79% for 9M 2026 after $161.3m of Limerick interruption costs in COGS and $14.8m in COCM; production was back to normal by 30 Jun 2026.
- Other income and tax: other income $246.5m against $755.8m as gains on securities fell; effective tax rate 14.7% against 17.2%, as Q3 2025 included a $44.5m deferred tax remeasurement.
- Call (30 Oct 2026): EYLEA HD physician unit demand +20% sequentially in Q3; management expects about 10% sequential demand growth in Q4, partly offset by price, and EYLEA demand down low to mid teens; EYLEA HD pre filled syringe approval targeted by end of 2026.
- Q2 2026 call (30 Jul 2026): EYLEA HD sales exceeded EYLEA for the first time; management expected a Q3 step up in Sanofi revenue after the development balance, about $3.1bn originally, was repaid.
Table 6.1 FY2026 guidance with every revision, and other outlook items
| Item | Outlook | Source |
|---|---|---|
| Revenue and EPS | not guided; guidance excludes business development not yet completed and acquired IPR&D | 8-K 30 Oct 2026, Ex 99.1 |
| Q4 2026 collaboration revenue | $1.0bn Sanofi up front payment to be recorded to collaboration revenue in Q4 2026; up to $7.0bn of further milestones | 10-Q Q3 2026 MD&A; Ex 99.1 |
| GAAP R&D | $6.600bn to $6.735bn (Jul: $6.500bn to $6.635bn; Jan: $6.450bn to $6.680bn) | Ex 99.1 of 30 Oct, 30 Jul and 30 Jan 2026 |
| Non GAAP R&D | $6.050bn to $6.150bn (Jul: $5.950bn to $6.050bn; Jan: $5.900bn to $6.100bn) | same |
| GAAP SG&A | $2.730bn to $2.860bn (Jul: $2.830bn to $2.960bn; Jan: $2.860bn to $3.040bn) | same |
| Non GAAP SG&A | $2.400bn to $2.500bn (Jul: $2.500bn to $2.600bn; Jan: $2.500bn to $2.650bn) | same |
| GAAP gross margin on net product sales | about 80% (Jul: 78% to 79%; Apr: 77% to 78%; Jan: 79% to 80%) | Ex 99.1 of 30 Oct, 30 Jul, 29 Apr and 30 Jan 2026 |
| Non GAAP gross margin on net product sales | about 86% (Jul: 84% to 85%; Jan: 83% to 84%) | same |
| GAAP COCM | $985m to $1.035bn, unchanged since Jul (non GAAP $970m to $1.020bn) | Ex 99.1 of 30 Oct 2026 |
| Capital expenditure | $1.050bn to $1.100bn (Jul: $1.030bn to $1.100bn; Apr: $1.100bn to $1.200bn; Jan: $1.100bn to $1.300bn); 9M 2026 $771m | Ex 99.1; 10-Q liquidity |
| GAAP effective tax rate | about 14% (Jul: 13% to 14%; Jan: 12% to 14%); non GAAP about 15% | Ex 99.1 of 30 Oct 2026 |
| Dividend | $0.94 per share payable 3 Dec 2026 to holders of record on 20 Nov 2026 | Ex 99.1 of 30 Oct 2026 |
| Buyback capacity | $2.157bn left at 30 Sep 2026 under the $3.0bn program of Apr 2026 | 10-Q Q3 2026 |
Management and CFO commentary
- CFO Christopher Fenimore, Q3 2026 release: third consecutive quarter of double digit growth in revenue and non GAAP EPS; the Sanofi step up in the first full quarter after repayment lifted revenue 36% and non GAAP EPS 70%.
- CFO, Q3 2026 release: guidance raised for GAAP gross margin to about 80% (from 78% to 79%); non GAAP tax rate about 15%; capex $1.05bn to $1.10bn.
- CFO, Q1 2026 call: Sanofi profit share $1.5bn, +42%; full profit share expected from Q3 after repayment by end of Q2; Limerick interruption cut GAAP gross margin to 76%; free cash flow $848m.
- CEO Leonard Schleifer, Q3 2026 release: record net sales for Dupixent, EYLEA HD and Libtayo; FDA decision on cemdisiran in generalized myasthenia gravis expected in Nov 2026; alliance with Sanofi widened to four long acting antibodies.
- CEO, Q1 2026 release: nearly 50 clinical candidates; the U.S. government agreement aligns prices with other high income countries.
- Marion McCourt, commercial, Q1 2026 call: EYLEA HD half of retina franchise net sales; Dupixent annualized sales near $20bn across more than 1.4m patients.
Table 6.2 Management statements in their own words
| Speaker | Date and source | Statement |
|---|---|---|
| Leonard Schleifer, co Chair, President and CEO | 30 Oct 2026, 8-K Ex 99.1 | “This was an outstanding quarter for Regeneron” |
| Christopher Fenimore, EVP Finance and CFO | 30 Oct 2026, 8-K Ex 99.1 | “positioning us to deliver one of our strongest years ever” |
| Marion McCourt, commercial lead | 29 Apr 2026, Q1 2026 call transcript | “EYLEA HD now contributes half of net sales for our retina franchise” |
Table 6.3 Key disclosures in the Forms 10-Q and 10-K
| Item | Disclosure |
|---|---|
| 10-Q Q3 2026, Sanofi | Profit share $2.57bn on $6.80bn of combined sales; development balance of $595m at 31 Dec 2025 fully repaid at 30 Jun 2026; Sixth Amendment adds four long acting IL 13, IL 4, IL 4R alpha and IL 4 x IL 13 antibodies with global profits and development costs shared 50/50 and an option on Sanofi's lunsekimig. |
| 10-Q Q3 2026, Bayer | Outside U.S. EYLEA 8 mg and EYLEA sales $642.7m (Q3 2025 $853.8m); Regeneron share of profits $211.5m after $14.8m of development cost reimbursement; Bayer balance of $296m at 31 Dec 2025 is repaid from 50% of Regeneron's profit share at 5% of the balance per quarter (10-K). |
| 10-Q Q3 2026, other revenue | Royalties and profit shares (Ilaris royalties from Novartis, ARCALYST profits from Kiniksa) $253.2m against $154.7m; other $56.8m. |
| 10-Q Q3 2026, R&D | Direct program costs $589.6m led by Lynozyfic $64.2m, the Factor XI antibodies $62.2m, Ordspono $57.9m and fianlimab $44.9m; itepekimab (COPD), REGN5713 to 5715 and REGN7999 discontinued in 2026. |
| 10-Q Q2 2026, U.S. Government Agreements | Medicaid prices at most favored nation levels for certain wholly owned products and future launches, Praluent on TrumpRx.gov, Otarmeni gene therapy free in the U.S.; exemption from Section 232 pharmaceutical tariffs to Jan 2029 tied to U.S. investment of more than $7bn plus about $2bn at Saratoga Springs. |
| 10-Q Q3 2026, legal | Dupixent T cell lymphoma product liability suits in a federal MDL (D.N.J., Jun 2026); new fianlimab securities class action (Jul 2026); Jan 2025 securities action dismissed in Sep 2026, under appeal; Praluent antitrust award against Amgen ($135.6m compensatory and $271.2m punitive) not recognized, post trial motions pending. |
| 10-K FY2025, patents | EYLEA U.S. formulation patents to Jun 2027 and method of treatment patents to Jan 2032; EYLEA HD U.S. patents to May 2039, one under PTAB review; Dupixent U.S. composition of matter patent to 28 Mar 2031 and EU protection to Sep 2032 or Mar 2033. |
| 10-K FY2025, tax | Effective tax rate 13.9% against the 21% statutory rate: Ireland rate differential (9.2) points, federal research credits (2.5) points, tax contingencies +2.4 points; unrecognized tax benefits that would affect the rate $520.9m. |
7 Peer Valuation & Sector Summary
- Summary across drivers: Regeneron's Q3 2026 revenue growth of 36.3% is second to LLY (38.6%) in the peer set; 9M growth was 24.4%. Operating margin TTM 28.8% against LLY 40.3%, VRTX 38.0% and AMGN 30.0%.
- Revenue model: 55.2% of Regeneron's TTM revenue is profit share from partners; reported revenue covers its share of underlying sales of Regeneron discovered products of about $25.7bn in 9M 2026, so margins and EV/Sales are not like for like with peers that record product sales.
- Valuation: REGN 4.8x EV/Sales and 20.8x TTM P/E with $16.2bn of net cash, against LLY 15.1x and 45.9x, VRTX 10.3x and 32.4x, AMGN 7.7x and 28.7x, BMY 3.2x and 13.8x; GILD 7.5x EV/Sales with a TTM loss.
Table 7.1 Peer comparison, latest reported trailing twelve months
| Company | Revenue TTM ($bn) | Revenue growth (%) | Gross margin (%) | Operating margin (%) | Net margin (%) | FCF margin (%) | ROE (%) | Net cash ($bn) | Market value ($bn) | EV/Sales (x) | P/E TTM (x) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| REGN | 16.9 | 36.3 | 85.8 | 28.8 | 28.5 | 22.6 | 14.4 | 16.2 | 98 | 4.8 | 20.8 |
| VRTX | 12.6 | 10.2 | 86.0 | 38.0 | 35.0 | 30.2 | 22.6 | 13.6 | 143 | 10.3 | 32.4 |
| AMGN | 38.1 | 7.8 | 69.5 | 30.0 | 23.0 | 26.7 | 86.0 | (43.3) | 251 | 7.7 | 28.7 |
| GILD | 31.0 | 6.8 | 79.9 | (7.6) | (12.5) | 44.5 | n/a | (19.8) | 212 | 7.5 | n/a |
| BMY | 50.0 | 6.9 | 69.9 | 23.1 | 21.7 | 18.6 | 44.1 | (29.9) | 128 | 3.2 | 13.8 |
| LLY | 86.5 | 38.6 | 83.6 | 40.3 | 31.9 | 22.7 | 68.5 | (44.6) | 1,264 | 15.1 | 45.9 |
Growth is the latest quarter year on year (REGN 9M 2026 +24.4%); VRTX and AMGN growth H1 2026 and margins TTM Q2 2026. REGN, LLY and GILD margins TTM Q3 2026; BMY operating and FCF margin TTM Q3 2026, gross and net margin 9M 2026. Gross margin for REGN is revenue less COGS and COCM. GILD operating and net loss after $11.8bn of acquired IPR&D. REGN price 2 Nov 2026; LLY and BMY market values 30 Oct 2026; other prices 2 Nov 2026. LLY market value on the EPS share count. ROE for REGN and LLY is TTM net income over period end equity.
8 Material Events & Contracts
- Ten Forms 8-K from Nov 2025 to Oct 2026: four results releases (Ex 99.1), three acquired IPR&D pre announcements, the J.P. Morgan conference release, the annual meeting results, the CEO and CSO PSU awards and the Sixth Amendment to the Sanofi collaboration. None was amended.
- Sixth Amendment (8-K of 6 Oct 2026): $1.0bn up front, to be recorded to collaboration revenue in Q4 2026 (10-Q), and up to $7.0bn of milestones; settles the information rights lawsuit Regeneron filed against Sanofi in Nov 2024.
Table 8.1 Forms 8-K filed in the last twelve months
| Date | Items | Event |
|---|---|---|
| 12 Jan 2026 | 2.02, 7.01, 9.01 | J.P. Morgan Healthcare Conference presentation (Ex 99.1) with preliminary Q4 2025 data: acquired IPR&D charge of about $19m ($0.14 per share); about $60m Q4 2025 SG&A charge for matching donations to Good Days. |
| 30 Jan 2026 | 2.02, 9.01 | Q4 2025 results (Ex 99.1): revenue $3.88bn (+3%), FY2025 $14.34bn (+1%); EPS $7.86, non GAAP $11.44; FY2025 Dupixent global sales $17.8bn (+26%); initial FY2026 guidance; dividend raised to $0.94; about $2bn Saratoga Springs manufacturing site planned. |
| 8 Apr 2026 | 2.02 | Q1 2026 acquired IPR&D charge of about $102m pre tax ($0.81 per share). No exhibits. |
| 29 Apr 2026 | 2.02, 9.01 | Q1 2026 results (Ex 99.1): revenue $3.61bn (+19%); EPS $6.75, non GAAP $9.47; $91.9m Limerick interruption costs in COGS; gross margin guidance cut to 77% to 78%; U.S. Government Agreements; new $3.0bn buyback. |
| 17 Jun 2026 | 5.07 | Annual meeting of 12 Jun 2026: five Class II directors elected, PwC ratified, say on pay approved. No exhibits. |
| 6 Jul 2026 | 2.02 | Q2 2026 acquired IPR&D charge of about $127m pre tax ($1.00 per share) for up front and opt in payments. No exhibits. |
| 30 Jul 2026 | 2.02, 9.01 | Q2 2026 results (Ex 99.1): revenue $4.29bn (+17%); EPS $12.23, non GAAP $14.29; Dupixent $6.0bn (+38%); Sanofi development balance fully repaid at 30 Jun 2026; guidance updated. |
| 30 Sep 2026 | 5.02, 9.01 | Ten year PSU awards to CEO Leonard Schleifer (cap 2.7m PSUs) and CSO George Yancopoulos (cap 2.9m) in place of annual equity awards until 2036; maximum requires nearly $30bn of annual revenue from new products (Ex 10.1, 10.2, 99.1); equity in new subsidiary Three Sevens Holding Corp. |
| 6 Oct 2026 | 1.01, 2.02, 8.01 | Sixth Amendment to the Sanofi antibody collaboration (1 Oct 2026): four long acting antibodies added, $1.0bn up front and up to $7.0bn of milestones, new product profits shared 50/50; Regeneron dismissed its Nov 2024 lawsuit; Q3 2026 acquired IPR&D about $22m ($0.18 per share). Agreement filed as Ex 10.4 to the Q3 2026 Form 10-Q. |
| 30 Oct 2026 | 2.02, 9.01 | Q3 2026 results (Ex 99.1): revenue $5.12bn (+36.3%); net income $1.95bn; EPS $18.45, non GAAP $20.07; Sanofi collaboration revenue $2.72bn; FDA approval of Pasatru (garetosmab) for FOP; gross margin and R&D guidance raised, SG&A guidance lowered. |
Table 8.2 Material contracts and financing arrangements
| Contract | Terms |
|---|---|
| Sanofi antibody collaboration (Sixth Amendment, Ex 10.4) | Dupixent and Kevzara: Sanofi records sales; U.S. profits 50/50, outside U.S. 35% rising to 45% for Regeneron; development balance repaid by 30 Jun 2026; four new antibodies with global profits and costs 50/50; $1.0bn up front, up to $7.0bn milestones. |
| Bayer EYLEA collaboration | Bayer records EYLEA 8 mg and EYLEA sales outside the U.S.; profits shared 50/50; $296m reimbursement balance at 31 Dec 2025 repaid from Regeneron's profit share. |
| Senior notes | 1.750% due 2030 ($1.24bn carrying value) and 2.800% due 2050 ($741.4m); interest about $44.4m a year. |
| Tarrytown headquarters lease financing | $720.0m, SOFR based, matures Mar 2027 with an option to extend five years or purchase; classified current at 30 Sep 2026. |
| Revolving credit facility | $750m, undrawn, matures Dec 2027, extendable. |
| U.S. Government Agreements (Apr 2026) | MFN pricing for Medicaid and future launches; Section 232 tariff exemption to Jan 2029 subject to U.S. investment commitments. |
| Business development 2025 to 2026 | Hansoh olatorepatide (GLP 1 and GIP) license, $80m up front (Jul 2025); Tessera, $150m paid (Jan 2026); Parabilis Medicines, $50m up front plus $75m equity (May 2026). |
| CEO and CSO PSU awards (Ex 10.1, 10.2) | Caps of 2.7m and 2.9m PSUs; revenue PSUs require at least $10bn of annual new product revenue, maximum near $30bn; shares held until Feb 2036; equity in Three Sevens Holding Corp. (Ex 10.3 to the Form 10-Q). |
9 Ownership, Voting Power & Annual Meeting
- Two share classes: 101.6m common shares (one vote, Nasdaq) and 1.82m unlisted Class A shares (ten votes) at 22 Oct 2026, so Class A carries 15.2% of votes. The 2026 proxy ownership table was not read for this analysis, so Class A holders and the directors and officers group stake are left out.
- Institutions (Schedule 13G): Vanguard Capital Management 7.66m shares, 7.37% (31 Mar 2026). No Schedule 13D in the last two years.
- Insiders, 12 months: no open market purchases; sales about $11m, all under preset trading plans, mostly after option exercises (Andrew Murphy about $3.2m, Marion McCourt $2.0m, Jason Pitofsky $1.6m, directors Zoghbi, Bassler and Guarini about $3.8m). CEO Schleifer and CSO Yancopoulos made no open market sales; each holds 595,077 vested 2020 PSUs in a holding period.
- Ten year PSU awards of 24 Sep 2026 replace annual equity grants for the CEO and CSO until 2036; at the $943.66 price the caps are worth about $2.5bn and $2.7bn if fully earned.
Table 9.1 Annual meeting vote results, 12 Jun 2026
| Proposal | For (bn votes) | Against (bn votes) | Abstain (bn votes) | For as % of votes cast | Result |
|---|---|---|---|---|---|
| Elect Joseph L. Goldstein | 0.072 | 0.031 | 0.000 | 70.1 | Elected |
| Elect Christine A. Poon | 0.079 | 0.024 | 0.000 | 76.8 | Elected |
| Elect David P. Schenkein | 0.099 | 0.004 | 0.000 | 96.0 | Elected |
| Elect Craig B. Thompson | 0.082 | 0.021 | 0.000 | 79.3 | Elected |
| Elect Huda Y. Zoghbi | 0.101 | 0.003 | 0.000 | 97.4 | Elected |
| Ratify PwC as auditor for FY2026 | 0.103 | 0.006 | 0.000 | 94.1 | Approved |
| Advisory vote on executive compensation | 0.096 | 0.007 | 0.000 | 93.3 | Approved |
Votes combine common stock (one vote) and Class A stock (ten votes). Broker non votes 5.5m on each item except the auditor ratification.
2026 annual meeting
- Virtual meeting of 12 Jun 2026: five Class II directors elected to serve until the 2027 meeting; PwC ratified; no shareholder proposals on the ballot.
- Director support: Joseph Goldstein 70.1% of votes cast, Christine Poon 76.8%, Craig Thompson 79.3%, David Schenkein 96.0%, Huda Zoghbi 97.4%; say on pay 93.3%.
- CEO update: strategy and business update; the available summaries report no figures.
Table 9.2 Holders of 5% or more from Schedules 13G, and earlier filings below 5%
| Holder | Shares (m) | % of class | As of |
|---|---|---|---|
| Vanguard Capital Management | 7.66 | 7.37 | 31 Mar 2026 |
| JPMorgan Chase & Co. | 4.74 | 4.4 | 30 May 2025 |
| FMR LLC | 3.36 | 3.2 | 30 Jun 2025 |
JPMorgan Chase and FMR reported holdings below 5% in amended filings of 2025. The Vanguard Group amended to zero in Mar 2026 after holdings moved to Vanguard Capital Management.
10 Risk Factors
- Item 1A of the FY2025 Form 10-K lists 35 summary risk factors in seven groups, as in FY2024; eight headings or opening factors were reworded, none added or removed. The comparison covers the summary headings and the first part of each Item 1A text.
Table 10.1 Risk factors and legal matters with filed figures
| Risk | Disclosure and change |
|---|---|
| Dependence on three products | Q3 2026 10-Q risk factor names Dupixent alongside EYLEA HD and EYLEA; U.S. EYLEA products were 31% of FY2025 revenue (42% in FY2024) and Sanofi collaboration revenue 41% (32%). |
| EYLEA biosimilars and patents | Amgen Pavblu on sale since Q4 2024; Samsung barred from the U.S. until Jan 2027 by settlement; more launches expected; patent case against Amgen with claim construction hearing on 1 Dec 2026; PTAB review of an EYLEA HD patent, oral argument 4 Dec 2026. |
| U.S. drug pricing | Apr 2026 agreements set MFN prices for Medicaid and future launches; Medicare negotiation for Part B drugs such as EYLEA HD and Libtayo from 2028; CMMI international reference pricing models proposed in Dec 2025. |
| Tariffs | Section 232 pharmaceutical tariffs effective 29 Sep 2026 for companies without agreements; Regeneron exempt to Jan 2029 subject to U.S. investment. |
| Partner dependence | Sanofi and Bayer record the sales behind 55% of TTM revenue; the 10-Q adds heavier reliance on Sanofi after the Sixth Amendment. |
| Manufacturing | Bulk production in Rensselaer, NY and Limerick, Ireland; Limerick interruption cost $176.1m in 9M 2026; prior complete response letters tied to third party filler inspections. |
| Government and product litigation | DOJ civil cases on patient assistance donations (2020) and EYLEA average sales price reporting (2024, 11 states intervened); qui tam case revived in part on 19 Aug 2026; Dupixent lymphoma MDL; amounts not estimable. |
| Dupixent exclusivity | U.S. composition of matter patent to 28 Mar 2031; EU protection to Sep 2032 or Mar 2033. |
How risk factors changed
- Comparison: 10-K FY2025 filed 4 Feb 2026 acc 0000872589-26-000008 against 10-K FY2024 filed 5 Feb 2025 acc 0001804220-25-000011.
- Scope as filed: the 35 summary risk factor headings of each year are matched one to one, and the first part of each Item 1A text (about 47KB of about 98KB) is compared; word counts and a full text comparison were not produced, so changes deeper in Item 1A may be missing. The Part II Item 1A sections of the 2026 Forms 10-Q were not compared line by line.
- Revenue concentration shifted from EYLEA to Dupixent: US EYLEA products fell to 31% of revenue from 42% while Sanofi collaboration revenue rose to 41% from 32%.
- Biosimilar competition moved into factor headings, with more US EYLEA biosimilar launches expected in H2 2026.
- Drug pricing text adds the 2025 MFN executive orders, the Jul 2025 presidential letter and CMMI international reference pricing models.
- Tariffs and trade restrictions now appear in a factor heading; FY2025 text names competition from Chinese biotechnology companies.
- The number of summary risk factors is unchanged at 35 across seven groups.
Table 10.2 Size of the risk factor section
| Measure | 10-K FY2024 | 10-K FY2025 |
|---|---|---|
| Risk factors (count) | 35 | 35 |
Table 10.3 Risk factors added, removed and materially reworded
| Change | Risk factor | What changed |
|---|---|---|
| Reworded | Substantial dependence on EYLEA HD, EYLEA and Dupixent | EYLEA HD now listed first; US EYLEA HD plus EYLEA fell to 31% of total revenue in 2025 from 42%, EYLEA HD rose to 37% of US EYLEA sales from 20%, Sanofi collaboration revenue rose to 41% of revenue from 32%, US EYLEA sales fell 42% against 17% a year earlier, and more EYLEA biosimilar launches are expected in H2 2026. |
| Reworded | Coverage, reimbursement and copay assistance | Heading adds copay assistance from third parties; text cites lost EYLEA share to compounded bevacizumab in 2025 because of patient affordability and limited charity copay funds. |
| Reworded | Pricing policies, regulations and pricing strategy | Heading adds pricing regulations and the company's own pricing strategy; text adds the May 2025 MFN executive order, the Jul 2025 presidential letter to Regeneron, the Apr 2025 order and two mandatory Medicare payment models proposed by CMMI in Dec 2025. |
| Reworded | Competition | Heading adds “including biosimilars”; Pavblu (Amgen) named as launched in Q4 2024. FY2025 text also names competition from Chinese biotechnology companies, including state backed enterprises; the FY2024 text compared did not reach this paragraph. |
| Reworded | Drug development and regulatory approval | Scope widened from “drug products” to “drug and biologic products”. |
| Reworded | Manufacturing regulatory compliance | Adds contract manufacturers alongside collaborators; commercialization factor adds FDA's increasing focus on manufacturing facilities and bulk manufacturing by third parties. |
| Reworded | Tax, tariffs and operations outside the US | Heading adds tariffs and other trade restrictions. |
| Reworded | Public health outbreaks | Drops the explicit COVID 19 pandemic reference. |
Table 10.4 Risk factor updates in quarterly reports since the annual filing
| Filing | Change disclosed |
|---|---|
| 10-Q Q1 2026 (0000872589-26-000016) | Not compared line by line; the filing discusses most favored nation pricing and tariffs (full text search). |
| 10-Q Q2 2026 (0000872589-26-000025) | Not compared line by line. |
| 10-Q Q3 2026 (0000872589-26-000034) | Changes read against the FY2025 Form 10-K: dependence risk now names Dupixent with EYLEA HD and EYLEA; new text on the Apr 2026 U.S. Government Agreements (MFN pricing); Section 232 pharmaceutical tariffs from 29 Sep 2026 (Regeneron exempt to Jan 2029); Section 301 tariffs of 10% or 12.5% from 24 Jul 2026; wider AI use risk; heavier reliance on Sanofi after the amendment; Medicare negotiation for Part B drugs from 2028. |
11 Stock Price, Scenarios & Sensitivity
- REGN traded at $943.66 on 2 Nov 2026, after a 13.3% rise on 30 Oct 2026 from $818.77 to $927.89; 1.4% below the 52 week high of $957.37 and 59.5% above the low of $591.52.
- Valuation: 20.8x TTM diluted EPS of $45.29; 17.1x TTM non GAAP EPS of $55.27; 4.8x EV/Sales; free cash flow yield 3.9%. TTM revenue excludes the $1.0bn Q4 2026 up front payment.
- Scenario model: revenue grows from TTM Q3 2026 $16.90bn for three years; operating margin as stated; net interest of $685m a year (Q3 2026 interest income of $181.8m less interest expense, annualized); 15% tax rate; 105.6m diluted shares adjusted for buybacks; price equals TTM Q3 2029 EPS times exit P/E.
Critical factors and core assumptions
Table 11.1 Critical factors behind the best case
| Factor | Current value | Best case requires | Evidence in filings and calls |
|---|---|---|---|
| Dupixent sales and profit share | Q3 2026 $6.54bn, +34.7%; profit share 37.9% of Dupixent and Kevzara sales | Dupixent above $30bn of sales by 2029; outside U.S. share at the 45% tier | Release Table 5; 10-Q collaboration note |
| EYLEA HD against biosimilars | U.S. EYLEA HD $698.8m (+62.3%); EYLEA $399.7m ((41.3%)) | U.S. franchise grows again from 2027 with the pre filled syringe | Q3 2026 call; 10-Q |
| Pipeline conversion | about 50 clinical candidates; Lynozyfic $19m; Pasatru approved Aug 2026 | several approvals 2026 to 2028 with multi billion dollar sales | PSU terms target $10bn to $30bn of new product revenue |
| Cost discipline | TTM R&D $6.60bn, 39.0% of revenue | R&D grows slower than revenue; operating margin mid 30s | SG&A guidance lowered twice in 2026 |
| U.S. pricing policy | MFN agreements; Part B negotiation from 2028 | limited price effect on EYLEA HD and Libtayo; tariff exemption kept | 10-Q Q3 2026 risk factors |
| Capital return | 9M 2026 buybacks $2.36bn; dividend $0.94 per quarter | share count falls about 2% a year | diluted shares 105.6m against 107.2m a year earlier |
- Revenue base TTM Q3 2026 $16.90bn; operating income $4.86bn (28.8% margin). The $1.0bn up front payment is treated as one time and left out.
- Best case: 10% revenue CAGR, 36% operating margin, 22x P/E, share count (6%).
- Base case: 5% revenue CAGR, 31% margin, 18x P/E, share count (3%).
- Worst case: (3%) revenue CAGR as more EYLEA biosimilars launch and pricing rules tighten, 22% margin, 13x P/E, share count unchanged.
- Profit splits unchanged: Sanofi 50/50 in the U.S. and up to 45% outside; no Dupixent biosimilar before 2031; no large acquisition.
Scenarios, three years forward
Table 11.2 Scenario analysis, TTM Q3 2026 to TTM Q3 2029
| Measure | Worst case | Base case | Best case |
|---|---|---|---|
| Revenue CAGR, 3 years (%) | (3.0) | 5.0 | 10.0 |
| Revenue, TTM Q3 2029 ($bn) | 15.4 | 19.6 | 22.5 |
| Operating margin, TTM Q3 2029 (%) | 22.0 | 31.0 | 36.0 |
| Net income, TTM Q3 2029 ($bn) | 3.5 | 5.7 | 7.5 |
| EPS, TTM Q3 2029 ($) | 32.82 | 56.00 | 75.19 |
| Exit P/E (x) | 13.0 | 18.0 | 22.0 |
| Implied price ($) | 427 | 1,008 | 1,654 |
| Change against $943.66 (%) | (55) | 7 | 75 |
| Implied annual return (%) | (23.2) | 2.2 | 20.6 |
Implied annual return excludes dividends ($0.94 per share quarterly).
Sensitivity analysis
Table 11.3 Sensitivity of implied price to revenue CAGR and operating margin at 18x P/E
| Revenue CAGR \ Operating margin | 22% | 26% | 31% | 34% | 36% |
|---|---|---|---|---|---|
| (3%) | $609 | $701 | $816 | $885 | $931 |
| 0% | $658 | $758 | $885 | $960 | $1,011 |
| 5% | $745 | $862 | $1,008 | $1,096 | $1,154 |
| 8% | $802 | $929 | $1,088 | $1,183 | $1,247 |
| 10% | $841 | $976 | $1,144 | $1,244 | $1,312 |
Cells show implied share price in year 3. Current price $943.66. Blue cells sit above it, red cells below.
Table 11.4 Sensitivity of implied price to exit P/E and operating margin at 5% revenue CAGR
| Exit P/E \ Operating margin | 22% | 26% | 31% | 34% | 36% |
|---|---|---|---|---|---|
| 13x | $538 | $622 | $728 | $791 | $833 |
| 15x | $621 | $718 | $840 | $913 | $962 |
| 18x | $745 | $862 | $1,008 | $1,096 | $1,154 |
| 20x | $828 | $958 | $1,120 | $1,217 | $1,282 |
| 22x | $911 | $1,053 | $1,232 | $1,339 | $1,410 |
Cells show implied share price in year 3. Current price $943.66. Blue cells sit above it, red cells below.
Disclaimer
This analysis is for information only and is not financial advice. It is derived from public SEC filings retrieved via sec-api.io and is not a publication of the U.S. Securities and Exchange Commission. Scenario values are model outputs under stated assumptions and are not forecasts. Data as of 2 November 2026.
Sources
All company figures are read from SEC filings retrieved through the sec-api.io MCP server. Call statements are taken from reports of the Q1 to Q3 2026 earnings calls held by the company; no full Q3 2026 transcript was available on 2 Nov 2026.
Table A.1 Filings used, with accession numbers
| Form | Period | Filed | Accession number |
|---|---|---|---|
| 10-Q | Q3 2026 | 30 Oct 2026 | 0000872589-26-000034 |
| 8-K (2.02) Ex 99.1 | Q3 2026 | 30 Oct 2026 | 0000872589-26-000032 |
| 8-K (1.01, 2.02, 8.01) | Oct 2026 | 6 Oct 2026 | 0001104659-26-113895 |
| 8-K (5.02) | Sep 2026 | 30 Sep 2026 | 0001104659-26-112340 |
| 10-Q | Q2 2026 | 30 Jul 2026 | 0000872589-26-000025 |
| 8-K Ex 99.1 | Q2 2026 | 30 Jul 2026 | 0000872589-26-000023 |
| 8-K (5.07) | AGM 2026 | 17 Jun 2026 | 0001104659-26-075127 |
| 10-Q | Q1 2026 | 29 Apr 2026 | 0000872589-26-000016 |
| 8-K Ex 99.1 | Q1 2026 | 29 Apr 2026 | 0000872589-26-000014 |
| DEF 14A | 2026 | 24 Apr 2026 | 0001308179-26-000340 |
| 10-K | FY2025 | 4 Feb 2026 | 0000872589-26-000008 |
| 8-K Ex 99.1 | Q4 2025 | 30 Jan 2026 | 0000872589-26-000004 |
| 8-K (2.02, 7.01) | Jan 2026 | 12 Jan 2026 | 0001104659-26-002691 |
| 10-K | FY2023 | 5 Feb 2024 | 0001804220-24-000009 |
| 10-K | FY2022 | 6 Feb 2023 | 0001804220-23-000008 |
| Schedule 13G | Mar 2026 | 30 Apr 2026 | 0002100119-26-001017 |
| Amgen 8-K Ex 99.1 | Q2 2026 | 4 Aug 2026 | 0000318154-26-000124 |
Table A.2 Peer and competitor filings used
| Company | Form | Filed | Accession number |
|---|---|---|---|
| AbbVie | 8-K Ex 99.1 | 30 Oct 2026 | 0001551152-26-000033 |
| Amgen | 8-K Ex 99.1 | 4 Aug 2026 | 0000318154-26-000124 |
| AstraZeneca | 6-K | 30 Oct 2026 | 0001654954-26-009256 |
| Bristol Myers Squibb | 10-Q (Q3 2026) | 29 Oct 2026 | 0000014272-26-000024 |
| Eli Lilly | 10-Q (Q3 2026) | 29 Oct 2026 | 0000059478-26-000108 |
| Johnson & Johnson | 10-Q (Sep 2026 quarter) | 21 Oct 2026 | 0000200406-26-000197 |
| Merck | 8-K Ex 99.1 | 29 Oct 2026 | 0001104659-26-119825 |
| Novartis | 6-K Ex 99.1 | 27 Oct 2026 | 0001114448-26-000014 |
| Summit Therapeutics | 8-K Ex 99.1 | 14 Sep 2026 | 0001599298-26-000078 |
Table B.1 Exhibits to Forms 8-K filed in the last twelve months
| Filed | Exhibit | Document | Content |
|---|---|---|---|
| 12 Jan 2026 | Ex 99.1 | J.P. Morgan Healthcare Conference presentation | Corporate update by Leonard Schleifer and George Yancopoulos with preliminary unaudited Q4 and FY2025 figures; Q4 2025 acquired IPR&D charge about $19m pre tax, about $0.14 per diluted share |
| 30 Jan 2026 | Ex 99.1 | Q4 and FY2025 results | Q4 2025 revenue $3.884bn (up 3%); FY2025 revenue $14.343bn (up 1%); FY2025 Dupixent global sales (recorded by Sanofi) $17.8bn (up 26%); Q4 2025 $4.9bn (up 34%) |
| 8 Apr 2026 | none | No exhibit other than the cover page | Item 2.02 text only: Q1 2026 acquired IPR&D |
| 29 Apr 2026 | Ex 99.1 | Q1 2026 results | Revenue $3.605bn (up 19%); Sanofi collaboration revenue $1.605bn (up 36%); Dupixent global sales $4.9bn (up 33%); EYLEA HD US $468m (up 52%); EYLEA US $473m (down 36%); Libtayo global $438m (up 54%) |
| 17 Jun 2026 | none | No exhibit other than the cover page | Item 5.07 vote results in the 8-K body |
| 6 Jul 2026 | none | No exhibit other than the cover page | Item 2.02 text only: Q2 2026 acquired IPR&D |
| 30 Jul 2026 | Ex 99.1 | Q2 2026 results | Revenue $4.291bn (up 17%); Sanofi collaboration revenue $2.174bn (up 51%); Bayer $276m (down 33%); Dupixent global sales $6.0bn (up 38%); EYLEA HD US $596m (up 52%); EYLEA US $412m (down 45%); Libtayo $489m (up 30%) |
| 30 Sep 2026 | Ex 99.1 | Supplemental information on 2026 CEO and CSO PSU awards | One time 10 year PSU awards to Leonard Schleifer and George Yancopoulos replace annual equity grants until 2036; Maximum earnout requires nearly $30bn of annual revenue from newly approved products; no revenue PSUs below $10bn |
| 30 Sep 2026 | Ex 10.1 | 2026 PSU award agreement, CEO | CEO cap 2,700,000 PSUs, activity based earnout capped at 100,000 PSUs below $10bn of new product revenue |
| 30 Sep 2026 | Ex 10.2 | 2026 PSU award agreement, CSO | CSO cap 2,900,000 PSUs, activity based earnout capped at 300,000 PSUs below $10bn of new product revenue |
| 6 Oct 2026 | none | No exhibit other than the cover page | Items 1.01, 2.02, 8.01 text; agreement filed later as Ex 10.4 to the Form 10-Q |
| 30 Oct 2026 | Ex 99.1 | Q3 2026 results | Revenue $5.116bn (up 36%); Sanofi collaboration revenue $2.724bn (up 68%), profit share $2.575bn against $1.456bn; Dupixent global sales $6.5bn (up 35%); EYLEA HD US $699m (up 62%); EYLEA US $400m (down 41%); Libtayo $550m (up 51%) |
