Genmab: A Hidden Gem in Oncology with Catalysts on the Horizon

In an era where biotech stocks are often priced on potential rather than performance, Genmab A/S (NASDAQ: GMAB) stands out as an undervalued gem. Despite robust clinical data from its lead oncology therapies and a shareholder-friendly buyback program, the company trades at multiples far below its peers. Investors who prioritize catalyst-driven opportunities and value investing principles may find this a compelling entry point.

### Clinical Catalysts: A Pipeline of Breakthroughs
Genmab's recent clinical milestones underscore its potential to redefine treatment paradigms in hematologic malignancies and solid tumors.

#### Epcoritamab (Epkinly/TEPKINLY): Expanding into Combination Therapies
Epcoritamab, a first-in-class bispecific antibody targeting CD3 and CD20, has already secured accelerated approval in the U.S. and EU for relapsed/refractory follicular lymphoma (R/R FL). Now, Genmab is advancing combination therapies to broaden its addressable market:
- Phase 3 EPCORE FL-1 Trial: Results demonstrated a statistically significant improvement in overall response rate (ORR) for epcoritamab plus rituximab/lenalidomide (R2) in R/R FL patients. A supplemental Biologics License Application (sBLA) submission to the FDA is expected in late 2024, with potential approval by mid-2025.
- DLBCL Breakthrough: At the recent European Hematology Association (EHA) Congress, Genmab revealed data from its Phase Ib/II EPCORE NHL-2 trial. When combined with R-ICE (rituximab, ifosfamide, carboplatin, etoposide), epcoritamab achieved an 87% ORR in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients eligible for stem cell transplants, including a 65% complete response (CR) rate. This suggests epcoritamab could become a cornerstone in high-risk DLBCL regimens.

#### Rina-S (Rinatabart Sesutecan): A Promising ADC for Solid Tumors
Genmab's folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), Rina-S, is delivering encouraging results in heavily pretreated cancers:
- Endometrial Cancer: In the Phase 1/2 RAINFOL-01 trial, Rina-S achieved a 50% confirmed ORR in advanced endometrial cancer, with no severe ocular or neuropathic toxicities—a critical differentiator from competitors like Roche's Polivy.
- Ovarian Cancer Expansion: Genmab plans a Phase 3 trial (RAINFOL-02) for platinum-resistant ovarian cancer, targeting FDA approval by late 2026. If successful, Rina-S could carve out a significant niche in a $3.5 billion ADC market.



### Share Buyback: Strengthening Value for Long-Term Holders
Genmab's financial strategy reinforces its appeal to value investors:
- Aggressive Repurchases: As of June 13, 2025, the company had repurchased 95% of its 2.2 million-share buyback program, reducing dilution from restricted stock units (RSUs) and boosting EPS. The program, expected to conclude by July 10, has already shrunk outstanding shares by 3.95% of total capital.
- Strong Balance Sheet: With $3 billion in cash, Genmab can fund its buyback and R&D without dilution, a rarity in the biotech sector.



### Valuation: A Discounted Bargain
Genmab's valuation metrics starkly contrast its fundamentals:
- P/E of 11.26: Well below peers like Exelixis (P/E 9.9) and Axsome (P/E 6.4), despite stronger clinical progress.
- EV/FCF of 8.17: Reflects robust cash flow generation, with no debt.
- GuruFocus GF Value: Analysts estimate a $50.51 intrinsic value, implying a 132% upside from June 2025 prices.

### Risks to Consider
- Regulatory Delays: FDA approval timelines for epcoritamab's combination therapies or Rina-S could slip, though the data to date is compelling.
- Competitive Landscape: ADCs like Polivy (Roche) and loncastuximab tesirine (ADC Therapeutics) pose threats, requiring Genmab to demonstrate superior efficacy or safety.

### Investment Thesis: A Buy on Dip with Catalysts Ahead
Genmab's pipeline and financial discipline position it as a value play with multiple near-term catalysts:
1. FDA Decision for Epcoritamab/R2 in FL (H2 2025): Approval could expand revenue by 20-30%.
2. RAINFOL-02 Phase 3 Data (2026): Positive results for ovarian cancer would unlock a multibillion-dollar market.
3. Buyback Completion: Reducing shares further could lift EPS and attract institutional interest.

For value investors, Genmab's current price represents a rare opportunity to buy a clinically validated oncology leader at a discount. With a GF Value implying a near doubling from current levels, the risk-reward calculus leans heavily in favor of accumulation ahead of these catalysts.

Final Call: Buy Genmab on dips below $28/share, with a 12-month price target of $50. Monitor for FDA updates and ICML conference data (June 17-21, 2025) for near-term upside triggers.