Gossamer Bio, Inc. (GOSS)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 delivered $9.379M in total revenue (license + collaboration services), narrowing net loss to $(33.0)M or $(0.15) per share; cash and marketable securities were $294.5M with runway into H1 2027 .
• Clinical timelines maintained: PROSERA Phase 3 in PAH tracking to topline in Q4 2025; registrational Phase 3 in PH-ILD expected to commence in H2 2025; Japan granted Orphan Drug Designation for PAH in January 2025 .
• Prior quarters frame the setup: revenue was largely collaboration-related in Q3 ($9.48M) and dominated by a one-time $88.8M license revenue in Q2; Q4 revenue mix included $1.93M license and $7.45M collaboration revenue .
• Stock reaction catalysts near-term: unchanged PROSERA timeline, PH-ILD Phase 3 initiation in H2 2025, and continued KOL interest given tolerability profile vs. sotatercept; management emphasized best-in-class safety and a potential 25–30m 6MWD base-case outcome without hemoglobin increase as a compelling clinical profile .

What Went Well and What Went Wrong

What Went Well

• Clinical execution and timelines intact: “Topline results from the PROSERA Study are expected in the fourth quarter of 2025,” and PH-ILD Phase 3 to start H2 2025, preserving key 2025–2027 commercial path signals .
• Balance sheet durability: $294.5M in cash, cash equivalents and marketable securities at year-end; runway into H1 2027 reduces near-term financing risk .
• Regulatory momentum: Japan Ministry of Health, Labour and Welfare granted Orphan Drug Designation for PAH in January 2025, supporting international regulatory optionality .

What Went Wrong

• R&D investment rose YoY in Q4 (to $36.1M from $30.0M), reflecting continued spend into registrational programs; total liabilities increased to $285.8M from $249.1M YoY .
• Q4 revenue was modest and primarily non-product (license + collaboration services); ongoing absence of commercial product sales keeps P&L driven by external collaboration flows and OPEX .
• No standalone Q4 earnings call transcript available; investors relied on the March 12 Barclays fireside chat for qualitative context rather than a dedicated earnings Q&A .

Financial Results

Notes:

• Q4 revenue composition was mixed: $1.93M license revenue and $7.45M collaboration service revenue .
• FY context: Q2 included a one-time $88.8M license revenue tied to the Chiesi collaboration, which shaped 2024’s full-year total revenue of $114.7M .

KPIs and Balance Sheet (selected)

Guidance Changes

Earnings Call Themes & Trends

Note: No formal Q4 earnings call transcript published; themes below reflect Q2–Q3 releases and the Mar. 12, 2025 Barclays fireside chat.

Management Commentary

• CEO tone on 2025 objectives: “We believe that seralutinib... has the potential to reshape the treatment paradigm... the Gossamer team remains intensely focused on execution of the PROSERA Study to ensure topline results by end of the year.”
• Clinical program clarity: “Enrollment is ongoing in the PROSERA Study... primary endpoint is change in 6MWD at week 24... Topline results... expected in the fourth quarter of 2025.”
• International/regulatory: “Japan’s MHLW granted seralutinib Orphan Drug Designation... PMDA allowed inclusion of Japanese trial sites... PROSERA could form the basis of a marketing application in Japan.”
• Safety and efficacy positioning vs. sotatercept (fireside chat): “A 25–30-meter increase in 6-minute walk... without any increase in hemoglobin... would put us in best-in-class efficacy. We already know we have best-in-class safety.”
• Background sotatercept in PROSERA: “Very few patients [on stable background sotatercept]... I’d be shocked if we had more than a handful... by end of enrollment.”

Q&A Highlights

• PROSERA enrichment and patient severity: Management emphasized the REVEAL Lite risk score to enroll sicker patients vs. Phase 2, improving likelihood of detecting a treatment effect at week 24 .
• 6MWD outcome framing: Base-case 25–30m increase seen as “home run” if achieved without hemoglobin elevation, contrasting with sotatercept’s Hb-driven 6MWD contribution .
• Background sotatercept: Protocol allows it but requires stable dosing ≥6 months; very limited uptake expected due to tolerability/dose adjustments in real world .
• Market positioning: Seralutinib targeted as a long-duration, best-in-class safety/tolerability option, potentially as third-line after ERA/PDE5, with sotatercept later in sequence .
• Pricing philosophy: Intends to align with inhaled Tyvaso/low-dose sotatercept range, with longer time-on-therapy driving per-patient revenue opportunity .

Estimates Context

• S&P Global consensus for Q4 2024 EPS and revenue was unavailable at time of query due to a rate limit; therefore, we cannot provide a vs. consensus beat/miss assessment for this quarter. We will update when S&P Global data become available.
• Given the non-product revenue mix (license and collaboration services), reported results may be less comparable to prior consensus frameworks anchored on clinical-stage OPEX and collaboration accounting .

Key Takeaways for Investors

• Timelines unchanged and central: PROSERA topline remains a Q4 2025 catalyst; PH-ILD Phase 3 site activation expected in H2 2025—two major de-risking events within the next 12 months .
• Balance sheet provides runway into H1 2027, supporting completion of pivotal programs without immediate financing, a positive setup into data readout .
• Q4 revenue composition (license + services) underscores a P&L driven by collaboration accounting rather than product sales; watch for continued collaboration revenue cadence in 2025 .
• Competitive narrative leans on safety/tolerability and hemoglobin-neutral efficacy—management’s framing of a 25–30m 6MWD outcome as base-case sets investor expectations into topline .
• Limited background sotatercept in PROSERA reduces confounding; enrichment strategy aims to heighten sensitivity to efficacy at week 24 .
• Regulatory momentum (Japan Orphan Designation; PMDA site inclusion) expands optionality for global filings post-PROSERA .
• Trading lens: With timelines maintained and a strong cash runway, the next inflection is execution updates (enrollment completion, PH-ILD Phase 3 start); absence of an EPS/revenue consensus comparison this quarter limits near-term estimate revisions but preserves the 2H25 data-catalyst narrative .

Appendix: Other Relevant Q4-period Press Releases

• PVRI 2025 Congress: One oral and three posters on seralutinib (including synergy with sotatercept and sustained benefits/biomarkers in TORREY OLE) .

Sources:

• Q4 2024 press release and attached 8-K (financials, timelines, Orphan Designation, balance sheet)
• Q3 2024 press release (comparatives, cash, service revenue)
• Q2 2024 press release (one-time license revenue context, Chiesi collaboration structure)
• Barclays fireside chat transcript (qualitative clinical and competitive positioning; Q&A)