Regeneron's Strategic Momentum and Near-Term Catalysts: Buy Before the June Shareholder Meeting

Regeneron Pharmaceuticals (NASDAQ: REGN) is positioned at a pivotal juncture, with a robust pipeline, resilient financials, and a series of high-stakes corporate presentations set to redefine investor sentiment. The company’s Q1 2025 results, while showing revenue headwinds in legacy products, underscore its ability to pivot toward growth drivers like Dupixent and EYLEA HD. Meanwhile, its May 20 presentation at the RBC Capital Markets Global Healthcare Conference unveiled breakthroughs in COPD, oncology, and anticoagulation that could propel REGN shares higher ahead of its June 13 shareholder meeting. Here’s why now is the time to act.

Q1 2025 Financials: Resilience Amid Transition

Regeneron’s first-quarter results revealed a mix of challenges and opportunities. While total revenue dipped 4% to $3.03 billion due to declining EYLEA sales (down 39% in the U.S. to $736 million), Dupixent sales surged 19% globally to $3.67 billion, driven by expanded indications in COPD (Japan) and chronic urticaria (U.S.). Non-GAAP net income fell 17% to $928 million, reflecting higher R&D spending (+6% to $1.33 billion) on its ambitious pipeline.

The key takeaway? Dupixent is the engine of growth, and its addressable market is expanding. With a 16% jump in GAAP EPS to $7.27, Regeneron’s profitability remains intact despite EYLEA’s struggles. The company also returned $1.05 billion to shareholders via buybacks, with $3.87 billion remaining under its program—a clear sign of confidence.

Pipeline Progress: From COPD to Oncology, This Is a Game-Changer

At the RBC conference, Regeneron unveiled data that could redefine its future:
1. Itapacumab for COPD: Targeting the IL-33 pathway, this therapy aims to reduce exacerbations by 20% in low-eosinophil patients, a subset with no effective treatments. An interim efficacy analysis has boosted confidence in Phase III success, with a readout expected in late 2025.
2. Libtayo/Fianlimab in Melanoma: A PD-1/LAG-3 combo showed 50–60% response rates in first-line metastatic melanoma, outperforming rivals. Phase III data, due by year-end, could position this as a new standard of care.
3. Factor XI Anticoagulant: A safer alternative to existing therapies, with genetic data suggesting reduced bleeding risks. Phase III trials are imminent, targeting high-risk populations first.

The 23andMe acquisition also looms large: combining its genetic database with Regeneron’s proprietary insights could accelerate drug discovery and personalize treatments, creating a moat against competitors.

Why the RBC Presentation Was a Catalyst for Confidence

The May 20 presentation was a masterclass in strategic storytelling. Management emphasized:
- Genetic Validation: Regeneron’s Genetics Center, with data on millions of patients, underpins its ability to pick “winners” like IL-33 in COPD and NPR1 in anticoagulation.
- Best-in-Class Molecules: Its antibody design platform ensures therapies like Libtayo (vs. Keytruda) and bispecifics for myeloma outperform rivals.
- Execution Track Record: 8/8 Phase III wins for Dupixent and the rapid development of EYLEA HD (now at $307M in Q1 sales) show a team that delivers.

The takeaway? Regeneron isn’t just a biotech—it’s a technology-driven pharmaceutical powerhouse.

Upcoming Catalysts to Watch

• June 13 Shareholder Meeting: Expect updates on the 23andMe integration and pipeline priorities.
• Q3/Q4 2025 Data Readouts:
• Itapacumab COPD Phase III (H2 2/025): A success could add $500M+ in annual sales by 2027.
• Libtayo/Fianlimab Melanoma (Q4): A win here could redefine oncology checkpoint therapy.
• FDA Decisions: EYLEA HD’s retinal vein occlusion application (August 2025) and the Factor XI program’s regulatory path.

Risk Factors—And Why They’re Manageable

• EYLEA Declines: Biosimilar competition is inevitable, but EYLEA HD’s 54% sales growth shows patient migration is underway.
• Regulatory Hurdles: The FDA’s Complete Response Letter for EYLEA HD’s pre-filled syringe (a supplier issue, not safety) is being addressed swiftly.
• 23andMe Integration: Privacy and data-use concerns exist, but Regeneron’s track record in regulatory matters gives comfort.

Valuation and Investment Thesis

At current levels, REGN trades at 19x 2025 consensus EPS—a discount to peers like Roche (RHHBY) and Amgen (AMGN). With Dupixent’s dominance and a pipeline poised to deliver, a rerating is inevitable.

Buy Recommendation:
- Price Target: $650–$700 (25–30% upside from current levels).
- Risks: Pipeline failures or delays, but the RBC data suggests these are low-probability outcomes.

Final Call to Action

Regeneron is at a tipping point. Its Q1 results show resilience, its pipeline is firing on all cylinders, and the RBC presentation has primed investors for a wave of catalysts. With the June shareholder meeting and Phase III readouts ahead, now is the time to buy REGN. The data—and the pipeline—are clear: this is a buy-and-hold growth story with multiyear upside.

Disclosure: The author holds no position in Regeneron at the time of writing.