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NEKTAR THERAPEUTICS (NKTR)·Q1 2025 Earnings Summary
Executive Summary
- Q1 2025 revenue was $10.46M, down year-over-year due to the sale of the Huntsville manufacturing facility eliminating product sales; GAAP net loss was $50.9M (–$0.24 per share) and non-GAAP net loss (ex-equity method loss) was $46.4M (–$0.22 per share) .
- Management guided FY 2025 revenue to ~$40M, R&D $110–$120M, G&A $60–$65M, non-cash interest expense ~$20M; cash runway into Q4 2026 and expected year-end cash/investments of ~$100M .
- Versus SPGI consensus for Q1 2025, revenue missed ($10.46M vs $15.36M*) and reported GAAP EPS is not directly comparable to SPGI “Primary EPS” (–$2.496* estimate; –$3.606* actual) which reflects SPGI normalization rather than GAAP per-share figures .
- Near-term stock catalysts center on June topline REZOLVE-AD Phase 2b induction data in atopic dermatitis and December REZOLVE-AA topline data in alopecia areata; FDA Fast Track designation for AD supports regulatory interactions post-Phase 2 .
What Went Well and What Went Wrong
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What Went Well
- “We are on track to report topline data in June from the Phase 2 study of rezpegaldesleukin in atopic dermatitis… [and] in December… in alopecia areata,” highlighting two value-creating catalysts in 2025 .
- FDA Fast Track designation for rezpegaldesleukin in AD enhances regulatory engagement and potential expedited review; global Phase 2b AD trial enrollment completed (398 patients) .
- Strong liquidity: $220.7M cash and investments; runway into Q4 2026 per CFO, supporting key trials without near-term dilution .
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What Went Wrong
- Revenue declined YoY to $10.46M from $21.64M due to elimination of product sales after Huntsville facility sale; non-cash equity method loss of $4.5M from Gannet BioChem widened GAAP net loss .
- R&D and G&A increased YoY (R&D $30.5M vs $27.4M; G&A $24.3M vs $20.1M), reflecting development and legal costs, partially offsetting COGS elimination .
- Q1 2025 revenue missed SPGI consensus by ~$4.9M*; SPGI “Primary EPS” framework shows a larger loss than GAAP per-share, complicating comparisons and potentially pressuring sentiment near-term .
Financial Results
Revenue composition (Q1 2025):
- Non-cash royalty revenue: $10.460M; License/collaboration: $0.000M; Product sales: $0.000M .
Cash and investments:
- Cash & investments: $220.7M (3/31/2025) vs $269.1M (12/31/2024) .
Guidance Changes
Note: No prior formal guidance in Q4 press release; current ranges provided by CFO in Q1 call .
Earnings Call Themes & Trends
Management Commentary
- CEO Howard Robin: “As a first-in-class T regulatory cell biologic, rezpegaldesleukin is poised to emerge as an important novel mechanism to treat millions of patients with chronic autoimmune disorders” .
- CSO Jonathan Zalevsky: The AD Phase 2b aims to “identify a proper dose for an initial 16-week induction… and also… a maintenance dose regimen” with key secondary endpoints (EASI-75/90, vIGA, itch) and proactive steps to manage placebo rate via global sites and dermatologist-led centers .
- CFO Sandra Gardiner: “We ended the first quarter of 2025 with $220.7 million in cash and investments… expect quarterly revenue to remain at a similar level… totaling approximately $40 million for the full year… end 2025 with approximately $100 million” and runway into Q4 2026 .
Q&A Highlights
- AD Phase III planning: Company plans to pursue end-of-Phase II meeting based on 16-week induction data without waiting for maintenance completion; intent to keep momentum into Phase III .
- Dosing and design: Weight-based dosing will be maintained into Phase III; well-powered Phase 2b design increases probability of significance across dose arms .
- Placebo management: Expect lower placebo rates vs prior Phase 1b through geographic diversification and site quality controls .
- Partnership strategy: Nektar seeks collaboration to execute Phase III while retaining significant ownership; aims to minimize dilutive financing .
- Alopecia kinetics/remission: Longer induction (36 weeks) designed to capture hair regrowth dynamics; off-drug assessment to evaluate remittive potential versus JAK inhibitors .
Estimates Context
- Values marked with * are retrieved from S&P Global; caution: SPGI “Primary EPS” may reflect normalization and is not directly comparable to GAAP basic/diluted EPS per share. Values retrieved from S&P Global.
- Miss vs consensus: Revenue missed by ~$4.9M*, driven by elimination of product sales post-Huntsville sale; EPS comparisons are distorted by framework differences .
Key Takeaways for Investors
- Two near-term clinical catalysts (June AD induction topline; December AA topline) can re-rate the stock; Fast Track for AD supports expedited regulatory path if data are compelling .
- Q1 revenue mix is now entirely non-cash royalty; absence of product sales structurally lowers reported revenue versus 2024, a dynamic likely to persist through 2025 per guidance .
- Operating expenses skew higher in H1 due to AD study operations; expect non-ratable OpEx across quarters—use FY guidance ranges for modeling .
- Liquidity remains robust with runway into Q4 2026 and expected YE cash/investments ~$100M, but Phase III execution will likely require a partner; collaboration discussions planned .
- Oncology optionality via NKTR-255 readouts and external collaborations; immunology pipeline breadth with NKTR-0165/0166 adds medium-term value levers .
- Litigation against Lilly provides potential, non-core upside but low visibility; base case should exclude until milestones emerge .
- Near-term trading positioning should focus on AD topline readout expectations (placebo mitigation, endpoint breadth, dose selection clarity) and subsequent FDA interactions .
Appendix: Prior Quarter Comparatives and Q1 Supporting Data
- Q4 2024: Revenue $29.175M; GAAP EPS $0.03; included $40.4M gain from Huntsville sale; FY 2024 revenue $98.427M; FY GAAP net loss $118.961M .
- Q3 2024: Revenue $24.124M; GAAP EPS –$0.18; R&D $35.031M; G&A $18.957M .
- Q1 2025 balance sheet: Cash & equivalents $38.894M; short-term investments $179.738M; total cash & investments $220.7M; total liabilities $242.503M; equity $13.738M .
Relevant press releases (Q1 2025):
- FDA Fast Track for AD (Feb 10, 2025) .
- TrialNet Phase 2 T1D collaboration (Feb 24, 2025) .
- Completion of AA Phase 2b enrollment (Feb 26, 2025) .