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GYRE THERAPEUTICS, INC. (GYRE)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $27.9M, up 3.0% year-over-year and 9.4% sequential; operating income of $0.7M and net income of $0.6M reflected lapping large in‑process R&D charges in Q4 2023 and controlled OpEx .
  • FY25 revenue guidance introduced at $118–$128M, implying 11.3%–20.8% growth vs FY24; driven by PRC launches of nintedanib and avatrombopag plus ETUARY sales momentum .
  • Commercial portfolio traction continued: ETUARY FY24 net sales were $105.0M; new launches are expected to expand the pulmonary fibrosis and hematology footprint in 2025 .
  • Clinical catalysts near term: topline Phase 3 F351 (CHB-associated liver fibrosis) data expected in Q2 2025; U.S. Phase 2 MASH-associated liver fibrosis trial initiation targeted for 2025 .

What Went Well and What Went Wrong

What Went Well

  • Sequential revenue growth (+9.4% QoQ) and positive operating income ($0.7M) in Q4 reflect disciplined spending and normalization after prior one-offs .
  • Commercial readiness: “We plan to expand and enhance our commercial product offerings through the additions of nintedanib… as well as avatrombopag…” underscoring confidence in 2025 launches and PRC sales platform .
  • Pipeline momentum: “We expect to share topline data from our pivotal Phase 3 trial in CHB-associated liver fibrosis in the second quarter of 2025,” a near-term clinical catalyst that can reshape the growth profile .

What Went Wrong

  • FY24 revenue declined to $105.8M from $113.5M, driven by weaker ETUARY and generic sales amid macro softness in China; adjusted net income fell to $16.9M from $25.4M .
  • Q4 non-GAAP adjusted net income slipped to $1.1M versus $2.1M in Q4 2023, with public company costs offsetting benefits from lower R&D and G&A variability .
  • Limited quarter-specific product detail for ETUARY in Q4 versus Q2–Q3 disclosures, reducing transparency on intra-quarter product mix; management cited market expansion qualitatively but did not quantify product splits for Q4 .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$25.225 $25.488 $27.872
Cost of Revenues ($USD Millions)$0.770 $0.958 $1.177
Gross Profit Margin (%)96.9% (calc from )96.2% (calc from )95.8% (calc from )
Income from Operations ($USD Millions)$3.262 $4.233 $0.665
Operating Margin (%)12.9% (calc from )16.6% (calc from )2.4% (calc from )
Net Income ($USD Millions)$4.538 $2.856 $0.569
EPS – Basic ($USD)$0.04 $0.01 $0.00
EPS – Diluted ($USD)$0.01 $0.01 $0.00
Non-GAAP Adjusted Net Income ($USD Millions)$3.138 $4.395 $1.145

YoY Q4 lens: Revenue +$0.8M to $27.9M, cost of revenues down $0.1M, operating income improved to $0.7M from $(91.1)M due to lapping acquired in‑process R&D in Q4 2023; net income improved to $0.6M from $(101.0)M .

Segment/KPI Highlights

KPI / SegmentQ2 2024Q3 2024Q4 2024
ETUARY Sales ($USD Millions)$25.1 $25.3 N/A (not disclosed)
Cash & Cash Equivalents ($USD Millions)$16.1 $15.9 $11.8 (balance sheet); $51.2 incl. short/long-term bank deposits
Short-Term Bank Deposits ($USD Millions)$9.0 $9.226 $14.858
Long-Term Certificates/Deposits ($USD Millions)$28.8 $29.515 $24.568
Selling & Marketing ($USD Millions)$14.414 $13.699 $16.856
R&D ($USD Millions)$3.355 $2.775 $3.712
G&A ($USD Millions)$3.424 $3.823 $5.464

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025N/A$118–$128M Introduced

Notes: Guidance assumes constant FX and no significant economic disruption .

Earnings Call Themes & Trends

Transcript for Q4 2024 was not available via our document tools or IR archives; themes below reflect disclosures from Q2–Q4 press releases.

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Commercial launches (nintedanib, avatrombopag)Nintedanib rights acquired; avatrombopag NMPA approval; launch plans in PRC Launch timelines reiterated; avatrombopag expected 1H25; nintedanib 2025 Launches expected in 2025; expanding PRC presence Consistent execution; nearing commercialization
F351 clinical programPhase 3 CHB topline by early 2025; planning U.S. IND and Phase 2a MASH in 2025 Last patient completed; topline expected Q1 2025; U.S. Phase 2 to initiate 2025 Topline expected Q2 2025; U.S. Phase 2 MASH to initiate 2025 Slight timing shift to Q2 2025; plan intact
Additional pipeline (F573, F230, F528)F573 Phase 2 ongoing; F230 IND approved; F528 preclinical F573 Phase 2 ongoing; F230 Phase 1 in 2025; F528 preclinical F573 Phase 2 completion by end 2026; F230 Phase 1 in 2025; F528 IND in 2026 Clear timelines; steady progress
China macro impact on salesNormalization post COVID surge; FX headwind Demand softness impacting anti‑fibrosis sales FY24 revenue decline tied to macro and healthcare spending softness Macro headwinds persisted in FY24
Corporate/governance updatesRussell index additions, board appointment Board appointment (Epstein) Board changes incl. new lead independent director; chair transition at PRC subsidiary Governance refresh continues

Management Commentary

  • “2025 is shaping up to be a pivotal year for Gyre… we are confident in our ability to successfully launch and expand these two products in the PRC.” — Han Ying, Ph.D., CEO .
  • “We expect to share topline data from our pivotal Phase 3 trial in CHB-associated liver fibrosis in the second quarter of 2025, which will help inform our U.S. Phase 2 proof-of-concept trial of F351 in MASH-associated liver fibrosis.” — Han Ying, Ph.D., CEO .
  • Commercial context: ETUARY FY24 net sales of $105.0M underpins the PRC commercial base to support nintedanib and avatrombopag launches .

Q&A Highlights

No Q4 2024 earnings call transcript was available in our document system or IR archives; therefore, Q&A themes and clarifications are not accessible for this quarter .

Estimates Context

  • S&P Global (Capital IQ) Wall Street consensus for Q4 2024 EPS and revenue, and FY2025 revenue/target price were unavailable due to SPGI daily request limits during retrieval; as a result, we cannot quantify beats/misses this quarter. Values would be retrieved from S&P Global when accessible.
  • Given the lack of consensus figures, focus shifts to management’s FY25 revenue guidance of $118–$128M and upcoming clinical/commercial catalysts as primary drivers of estimate revisions and stock narrative .

Key Takeaways for Investors

  • Revenue stability with sequential growth and positive operating income in Q4 suggests normalized run-rate post 2023 one-offs; FY24 softness was macro-driven in PRC anti‑fibrosis demand .
  • Bolded catalyst: FY25 revenue guidance $118–$128M targets double-digit growth, anchored by two product launches and ETUARY base; monitor launch timing, pricing, and reimbursement in PRC to gauge attainment .
  • Near-term clinical inflection: F351 Phase 3 CHB fibrosis topline in Q2 2025 could validate platform and inform U.S. Phase 2 MASH strategy; outcome will be material for medium-term valuation .
  • Expense discipline matters: Q4 operating income benefit vs prior year driven by lapping in‑process R&D; sustained control of S&M/G&A will be key to margin trajectory in 2025 .
  • Liquidity mix: Year-end liquidity included cash plus bank deposits totaling $51.2M; balance sheet shows cash of $11.8M, with significant certificates/deposits supporting operational runway .
  • Watch China macro/healthcare spending trends: FY24 declines reflected demand softness; product launches diversify revenue drivers but macro sensitivity remains .
  • Trading implications: Shares likely to react to (1) F351 topline timing/data quality, (2) PRC launch execution for nintedanib/avatrombopag, and (3) any updates to FY25 guidance as launches progress .