GYRE THERAPEUTICS, INC. (GYRE)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 revenue was $22.06M, down 18.8% year over year and 20.8% sequentially, reflecting lower ETUARY sales after a one-time Q1 2024 campaign, macro softness in China, and increased IPF competition; GAAP net income was $3.73M and GAAP basic EPS was $0.03. Management reaffirmed FY2025 revenue guidance of $118–$128M, citing H2 contributions from nintedanib and avatrombopag .
• Commercial catalysts: initial avatrombopag revenue of $0.3M in March launch; nintedanib commercialization on track for May 2025, expected to support second-half growth; ETUARY delivered $21.7M in Q1 sales despite the YoY decline .
• Pipeline catalysts: Hydronidone (F351) Phase 3 in CHB-associated liver fibrosis achieved database lock; topline results expected in Q2 2025, positioning Gyre for a U.S. Phase 2 in MASH .
• Liquidity: Cash, equivalents, and deposits totaled $51.3M at 3/31/25; management believes cash plus operating cash flow funds 12 months of requirements .
• Street context: No S&P Global consensus estimates were available for Q1 2025 EPS or revenue in our pull; coverage appears limited. Values retrieved from S&P Global.*

What Went Well and What Went Wrong

What Went Well

• Reaffirmed FY2025 revenue guidance at $118–$128M, underscoring confidence in commercial execution and upcoming launches, with management highlighting “a meaningful step forward in expanding our market presence” and the initial push into oncology supportive care via pirfenidone in RILI/CIP .
• Positive operating profitability despite revenue pressure: income from operations was $2.27M (vs. $0.67M in Q4 2024), aided by disciplined selling and marketing spend; gross margin remained structurally high given low cost of revenues .
• Pipeline and portfolio progression: avatrombopag commercialization began in March; nintedanib commercialization on track for May; F351 pivotal program locked and on track for Q2 topline readout .

What Went Wrong

• Revenue fell $5.11M YoY primarily due to a $5.2M ETUARY decline after a non-recurring Q1 2024 campaign, macroeconomic softness in China, and competition; generic products decreased $0.2M offset by $0.3M from avatrombopag .
• Operating expenses mix headwinds: R&D rose to $3.10M (data analysis for F351) and G&A rose to $5.00M (personnel/stock comp and annual meeting costs), pressuring operating leverage vs. Q1 2024 .
• Net income declined to $3.73M from $9.94M YoY, impacted by lower operating income and less favorable change in warrant fair value vs. prior year .

Financial Results

P&L comparison (YoY and sequential)

Notes: Gross Profit, Gross Margin %, and Net Income Margin % are calculated from cited revenue and cost/net income figures.

Non-GAAP

Reconciliation items include warrant fair value changes, stock-based compensation, and income taxes .

Product/Revenue detail (Q1 2025)

KPIs and Balance Sheet (Q1 2025)

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available in our document set; themes below draw from press releases.

Management Commentary

• “This quarter marked a meaningful step forward in expanding our market presence, particularly in the liver space… The successful launch of avatrombopag… and the recent NMPA approval to initiate a clinical trial of pirfenidone in radiation-induced lung injury… supports our ability to enter the oncology supportive care space.” – Han Ying, Ph.D., CEO .
• On revenue cadence and reaffirmed guide: management anticipates revenue growth over the remainder of 2025 driven by nintedanib (May launch) and avatrombopag ramp, and reaffirmed FY25 revenue guidance of $118–$128M .
• Liquidity positioning: $51.3M in cash and deposits at quarter-end; cash resources plus commercial cash flow expected to fund 12 months of operations .

Q&A Highlights

• No Q1 2025 earnings call transcript was available in our document set; no Q&A items to report.

Estimates Context

• S&P Global consensus estimates for Q1 2025 EPS and revenue were not available in our data pull; coverage appears limited for GYRE at this time. Values retrieved from S&P Global.*
• Implication: With no published consensus, we cannot quantify beats/misses; near-term estimate revisions (if any) are likely to hinge on nintedanib launch trajectory, avatrombopag ramp, and F351 topline.

Key Takeaways for Investors

• Near-term catalysts are stacked: nintedanib launch (May), avatrombopag ramp, and F351 CHB topline (Q2), all of which can re-accelerate revenue in H2 and alter the medium-term narrative .
• Despite revenue pressure, operating income remained positive and gross margins are structurally high; execution on OpEx discipline will be key as R&D and G&A saw YoY increases tied to program and public company costs .
• Reaffirmed FY2025 revenue guidance provides a confidence anchor; watch June–December monthly trajectories post-nintedanib launch to assess guide achievability .
• China macro and IPF competition remain the principal commercial risks; diversification into hepatology (avatrombopag) and ILD (nintedanib) should mitigate single-product dependence .
• Regulatory/clinical optionality: Positive F351 CHB data in the PRC could inform U.S. MASH strategy/timing and open an additional commercial vector longer-term .
• Liquidity supports near-term operations and launch activities; additional capital needs would depend on U.S. clinical pace and any incremental BD opportunities .
• With no visible consensus, stock reactions may skew to discrete catalysts (F351 topline, nintedanib uptake) and qualitative tone in future updates.

Citations:

• Q1 2025 8-K press release and financials
• Q4 2024 8-K press release and financials
• Q3 2024 8-K press release and financials

*Estimates note: S&P Global consensus was not available in our GetEstimates pull for GYRE during this analysis; Values retrieved from S&P Global.