- Third quarter 2024 revenues increased 11% to $3.72 billion versus third quarter 2023
- Third quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 23% to $3.82 billion versus third quarter 2023
- Third quarter 2024 U.S. net sales for EYLEA HD® and EYLEA® increased 3% versus third quarter 2023 to $1.54 billion, including $392 million from EYLEA HD
- Third quarter 2024 Libtayo® global net sales increased 24% to $289 million versus third quarter 2023
- Third quarter 2024 GAAP diluted EPS increased 30% to $11.54 and non-GAAP diluted EPS(a) increased 8% to $12.46 versus third quarter 2023; third quarter 2024 includes unfavorable $0.43 impact from acquired IPR&D charge
- FDA approved Dupixent as first-ever biologic therapy in U.S. for treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype
- Positive results reported for Dupixent pivotal trials in chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP); CSU sBLA resubmitted and BP sBLA submission planned for fourth quarter 2024
"Regeneron had a strong third quarter marked by 11% revenue growth. We continued to deepen the impact of our commercialized medicines this quarter, with ongoing leadership for our retinal franchise, expanded global reach of Libtayo, and notable growth from Dupixent," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Over one million patients around the globe are currently being treated with Dupixent, with more to come following the approvals for COPD in the U.S., Europe and China. Our remarkably diverse clinical portfolio now includes approximately 40 product candidates and many pivotal studies underway. We continue to invest in the world-class research and development engine that drives our scientific and clinical productivity, with data expected over the next twelve months in diseases as varied as non-small cell lung cancer, thrombosis, retinal vein occlusion, severe allergy, COPD, melanoma, and obesity."
Financial Highlights
| ($ in millions, except per share data) | Q3 2024 | Q3 2023 | % Change | ||||||
| Total revenues | $ | 3,721 | $ | 3,363 | 11 | % | |||
| GAAP net income | $ | 1,341 | $ | 1,008 | 33 | % | |||
| GAAP net income per share - diluted | $ | 11.54 | $ | 8.89 | 30 | % | |||
| Non-GAAP net income(a) | $ | 1,462 | $ | 1,329 | 10 | % | |||
| Non-GAAP net income per share - diluted(a) | $ | 12.46 | $ | 11.59 | 8 | % | |||
Business Highlights
Key Pipeline Progress
Regeneron has approximately 40 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:
EYLEA HD (aflibercept) 8 mg
- The Company announced positive three-year (156-week) data from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). At three years, the longer-term data showed the vast majority of EYLEA HD patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year. Of the EYLEA HD patients who completed the full 156 weeks of treatment, 48% were assigned a dosing interval of ≥20 weeks at the end of the third year. The results were presented at the American Academy of Ophthalmology (AAO) Annual Meeting.
- In September 2024, the U.S. Food and Drug Administration (FDA) approved Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. With this approval, Dupixent is the first biologic medicine approved in the United States, European Union (EU), and China to treat these patients.
- In September 2024, the FDA approved Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending expanded approval of Dupixent in the EU to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE). The European Commission (EC) is expected to announce a final decision in the coming months.
- The Company and Sanofi announced that a confirmatory Phase 3 trial met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores from baseline. This positive trial confirms results from the first Phase 3 trial of Dupixent in this setting and these data supported the recent resubmission of a supplemental Biologics License Application (sBLA) to the FDA.
- The Company and Sanofi announced that a Phase 3 trial in bullous pemphigoid met the primary and all key secondary endpoints evaluating the investigational use in adults with moderate-to-severe disease. In the trial, five times more Dupixent patients achieved sustained disease remission compared to those on placebo. This trial will support global regulatory submissions, including the anticipated fourth quarter 2024 submission in the United States.
- In August 2024, the EC approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
- The Company announced five-year results from the final pre-specified overall survival (OS) analysis of a Phase 3 trial, which evaluated Libtayo (cemiplimab) monotherapy versus chemotherapy as a first-line treatment for certain adults with advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The results were presented at the IASLC 2024 World Conference on Lung Cancer.
- The Company submitted a regulatory application in Japan for Libtayo for first-line advanced NSCLC (monotherapy and chemotherapy combination).
- A Phase 2 study for Libtayo in neoadjuvant NSCLC was initiated.
- The Company presented new, two-year results at the European Society for Medical Oncology (ESMO) Annual Meeting, evaluating the investigational combination of fianlimab, an antibody to LAG-3, and Libtayo in adults with advanced melanoma across three independent expansion cohorts of a first-in-human, multi-cohort trial. These longer-term results show high clinical activity, including deepening responses, per a blinded independent central review.
- In August 2024, the FDA issued a Complete Response Letter (CRL) for the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in R/R multiple myeloma that has progressed after at least three prior therapies. The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer. Resolution of this issue will be required for both FDA and EC regulatory approvals.
- A Phase 3 study was initiated for pozelimab, an antibody to C5, in combination with cemdisiran, an siRNA therapy, in geographic atrophy.
- A Phase 2 study for REGN7999, an antibody to TMPRSS6, for the treatment of iron overload in patients with beta-thalassemia was initiated.
Revenues
| ($ in millions) | Q3 2024 | Q3 2023 | % Change | |||||||
| Net product sales: | ||||||||||
| EYLEA HD - U.S. | $ | 392 | $ | 43 | * | |||||
| EYLEA - U.S. | 1,145 | 1,448 | (21 | %) | ||||||
| Total EYLEA HD and EYLEA - U.S. | 1,537 | 1,491 | 3 | % | ||||||
| Libtayo - Global | 289 | 232 | 25 | % | ||||||
| Praluent® - U.S. | 53 | 40 | 33 | % | ||||||
| Evkeeza® - U.S. | 32 | 19 | 68 | % | ||||||
| Inmazeb® - Global | 35 | 4 | * | |||||||
| Total net product sales | 1,946 | 1,786 | 9 | % | ||||||
| Collaboration revenue: | ||||||||||
| Sanofi | 1,263 | 1,065 | 19 | % | ||||||
| Bayer | 391 | 377 | 4 | % | ||||||
| Other | 6 | (3 | ) | * | ||||||
| Other revenue | 114 | 138 | (17 | %) | ||||||
| Total revenues | $ | 3,720 | $ | 3,363 | 11 | % | ||||
| * Percentage not meaningful | ||||||||||
Sanofi collaboration revenue increased in the third quarter of 2024, compared to the third quarter of 2023, due to an increase in the Company's share of profits from commercialization of antibodies, which were $1.09 billion in the third quarter of 2024, compared to $863 million in the third quarter of 2023. 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. Sanofi collaboration revenue in the third quarter of 2023 was positively impacted by the recognition of the final $50 million sales-based milestone.
Refer to Table 4 for a summary of collaboration revenue.
Operating Expenses
| GAAP | %
Change | Non-GAAP(a) | % Change | ||||||||||||||||
| ($ in millions) | Q3 2024 | Q3 2023 | Q3 2024 | Q3 2023 | |||||||||||||||
| Research and development (R&D) | $ | 1,272 | $ | 1,075 | 18 | % | $ | 1,146 | $ | 954 | 20 | % | |||||||
| Acquired in-process research and development (IPR&D) | $ | 56 | $ | 100 | (44 | %) | * | * | n/a | ||||||||||
| Selling, general, and administrative (SG&A) | $ | 714 | $ | 641 | 11 | % | $ | 613 | $ | 534 | 15 | % | |||||||
| Cost of goods sold (COGS) | $ | 262 | $ | 225 | 16 | % | $ | 217 | $ | 181 | 20 | % | |||||||
| Cost of collaboration and contract manufacturing (COCM) | $ | 229 | $ | 212 | 8 | % | * | * | n/a | ||||||||||
| Other operating expense (income), net | $ | 8 | $ | (1 | ) | ** | $ | - | * | ** | |||||||||
| * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded. | |||||||||||||||||||
| ** Percentage not meaningful | |||||||||||||||||||
- GAAP and non-GAAP R&D expenses increased in the third quarter of 2024, compared to the third quarter of 2023, driven by the advancement of the Company's clinical pipeline, including late-stage oncology programs, and higher headcount and headcount-related costs.
- Acquired IPR&D for the third quarter of 2024 included a $45 million development milestone in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc. Acquired IPR&D expense in the third quarter of 2023 related to a $100 million development milestone in connection with the Company's collaboration with Alnylam Pharmaceuticals, Inc.
- GAAP and non-GAAP SG&A expenses increased in the third quarter of 2024, compared to the third quarter of 2023, due to higher commercialization-related expenses to support the Company's launch of EYLEA HD and higher headcount and headcount-related costs partly related to the Company's international commercial expansion.
- GAAP and non-GAAP COGS increased in the third quarter of 2024, compared to the third quarter of 2023, primarily due to higher start-up costs for the Company's Rensselaer, New York fill/finish facility.
GAAP other income (expense) included the recognition of net unrealized gains on equity securities of $135 million in the third quarter of 2024, compared to $100 million of net unrealized losses in the third quarter of 2023. GAAP and Non-GAAP other income (expense) also included interest income of $187 million in the third quarter of 2024, compared to $134 million in the third quarter of 2023.
In the third quarter of 2024, the Company's GAAP effective tax rate (ETR) was 10.2%, compared to 9.3% in the third quarter of 2023. The GAAP ETR increased in the third quarter of 2024, compared to the third quarter of 2023, due to a lower benefit from income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate. In the third quarter of 2024, the non-GAAP ETR was 10.7%, compared to 11.9% in the third quarter of 2023.
GAAP net income per diluted share was $11.54 in the third quarter of 2024, compared to $8.89 in the third quarter of 2023. Non-GAAP net income per diluted share was $12.46 in the third quarter of 2024, compared to $11.59 in the third quarter of 2023. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.
During the third quarter of 2024, the Company repurchased shares of its common stock and recorded the cost of the shares, or $738 million, as Treasury Stock. As of September 30, 2024, $2.9 billion remained available for share repurchases under the Company's share repurchase program.
2024 Financial Guidance(c)
The Company's full year 2024 financial guidance consists of the following components:
| 2024 Guidance | ||||
| Prior | Updated | |||
| GAAP R&D | $5.020-$5.170 billion | $5.055-$5.145 billion | ||
| Non-GAAP R&D(a) | $4.500-$4.600 billion | $4.525-$4.575 billion | ||
| GAAP SG&A | $2.920-$3.060 billion | $2.930-$3.020 billion | ||
| Non-GAAP SG&A(a) | $2.550-$2.650 billion |
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