Executive Summary

Q2 2025 revenue was $26.8M (+6% YoY), GAAP basic EPS was $0.00; non‑GAAP adjusted net income was $2.9M, reflecting higher operating expenses offsetting new product contributions .
Product mix shifted: ETUARY® sales declined YoY while Etorel (nintedanib) and Contiva (avatrombopag) contributed first partial quarter revenues post launch; full‑year revenue guidance of $118–$128M was reaffirmed and maintained .
Strategic pipeline catalysts: Hydronidone (F351) met the pivotal Phase 3 primary endpoint in CHB‑associated liver fibrosis; the company plans an NMPA NDA submission in Q3 2025 and a U.S. Phase 2 MASH fibrosis trial in 2H 2025 .
Leadership change: Ping Zhang was appointed Interim CEO with Dr. Han Ying transitioning to SVP, Science; management emphasized global expansion and accelerating fibrosis‑first programs as key drivers .
No Wall Street consensus estimates were available via S&P Global for Q2; results cannot be benchmarked to street expectations at this time (consensus unavailable; Values retrieved from S&P Global).*

What Went Well and What Went Wrong

What Went Well

New launches drove incremental sales: Etorel generated $1.6M and Contiva $1.5M in Q2, supporting revenue growth despite ETUARY® pressure .
Hydronidone pivotal success: “Achieved statistically significant ≥1‑stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002)”—a potential first‑in‑class anti‑fibrotic for CHB fibrosis with accelerated approval path in China .
Management focus and continuity: “As interim CEO, I am excited to work closely with our leadership team to strengthen Gyre’s global footprint and accelerate our progress toward delivering transformative therapies to patients” .

What Went Wrong

Margin compression and lower operating income: Income from operations fell to $2.2M from $3.2M YoY driven by $2.6M higher operating expenses (selling/marketing, G&A, R&D) .
ETUARY® headwinds: ETUARY® sales declined YoY due to 2024’s one‑time rural campaign, tougher macro in China, and increased competition in IPF; similar pressures drove the H1 revenue decline vs. prior year .
Net income lower YoY: Net income fell to $1.6M from $4.5M in prior‑year Q2, reflecting higher opex and reduced contribution from warrant liability fair value changes .

Financial Results

Metric	Q4 2024	Q1 2025	Q2 2025
Revenue ($USD Millions)	$27.872	$22.058	$26.771
GAAP Basic EPS ($)	$(0.00)	$0.03	$0.00
Net Income ($USD Millions)	$0.569	$3.734	$1.576
Non-GAAP Adjusted Net Income ($USD Millions)	$1.145	$2.887	$2.932
Income from Operations ($USD Millions)	$0.665	$2.273	$2.171
Cost of Revenues ($USD Millions)	$1.177	$0.894	$1.151
Gross Profit ($USD Millions)	$26.695	$21.164	$25.620
Gross Margin (%)	95.8%	95.9%	95.7%
EBIT Margin (%)	2.4%	10.3%	8.1%
Net Income Margin (%)	2.0%	16.9%	5.9%

Segment/Product Breakdown (Q2 2025)

Product	Q2 2025 Sales ($USD Millions)
ETUARY® (pirfenidone)	$23.5
Etorel (nintedanib)	$1.6
Contiva (avatrombopag)	$1.5

Operating Expense Detail

Metric	Q4 2024 ($MM)	Q1 2025 ($MM)	Q2 2025 ($MM)
Selling & Marketing	$16.856	$10.841	$15.194
Research & Development	$3.712	$3.095	$3.425
General & Administrative	$5.464	$4.955	$4.829
Total Operating Expenses	$27.207	$19.785	$24.600

Balance Sheet / Liquidity KPIs

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash & Cash Equivalents ($MM)	$11.813	$15.045	$36.491
Short-Term Bank Deposits ($MM)	$14.858	$14.846	$17.874
Long-Term Certificates of Deposit ($MM)	$24.568	$21.367	$21.528
Total Cash, Equivalents & Deposits ($MM)	$51.2	$51.3	$75.9
Accounts Receivable, Net ($MM)	$19.589	$20.150	$24.629
Inventories, Net ($MM)	$6.337	$7.878	$8.861

Notes:

Gross profit and margins are calculated from cited Revenues and Cost of Revenues; all inputs and period references are cited above .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue ($USD Millions)	FY 2025	$118–$128	$118–$128	Maintained

No guidance provided for margins, OpEx, OI&E, tax rate, or dividends in these materials .

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available; themes below track narrative across the last three quarters via press releases.

Topic	Q4 2024 (Prior-2)	Q1 2025 (Prior-1)	Q2 2025 (Current)	Trend
Hydronidone clinical progress	Phase 3 CHB trial completed; topline data expected Q2 2025	Data lock and timing reaffirmed for Q2 2025	Pivotal Phase 3 met primary endpoint; NDA planned Q3 2025; U.S. Phase 2 in 2H 2025	Strong positive data; regulatory acceleration
Commercial launches (nintedanib, avatrombopag)	Plan to launch both in 2025	Avatrombopag launched Mar; nintedanib on track for May	Etorel (nintedanib) launched June; Contiva (avatrombopag) contributing	Execution progressing; new product contribution rising
ETUARY® performance	$105.0M FY sales; market leader; macro pressures noted	Q1 decline vs elevated prior year; competition and macro cited	Q2: YoY decline; partially offset by new products	Stable leadership but pressured; mix shift underway
China macro/competition	Macro impacts on IPF and healthcare spend	Weaker economy and competitive IPF landscape	Continued competition and macro pressures	Persistent headwind
U.S. expansion (MASH)	Plan to initiate U.S. Phase 2 in 2025	Strategy reiterated	IND and Phase 2 timing in 2H 2025	Advancing toward U.S. proof‑of‑concept
Corporate/Leadership	Board changes and governance updates	Exec Chair appointment (Ping Zhang)	Interim CEO appointment; CEO transition to SVP, Science	Leadership aligned to scale/org focus

Management Commentary

Ping Zhang (Interim CEO): “As interim CEO, I am excited to work closely with our leadership team to strengthen Gyre’s global footprint and accelerate our progress toward delivering transformative therapies to patients.”
Han Ying (CEO, Q1 2025): “The successful launch of avatrombopag and our growing commercial footprint with hepatology and hematology specialists provide a strong foundation for our future growth.”
Clinical positioning: “Hydronidone may become the first therapy specifically indicated for reversing liver fibrosis in CHB patients… foundation for broader expansion into MASH‑related fibrosis in the United States.”

Q&A Highlights

No Q2 2025 earnings call transcript was available; therefore, no Q&A highlights or guidance clarifications could be extracted (searched and not found) [ListDocuments earnings-call-transcript: 0].

Estimates Context

Wall Street consensus estimates for revenue, EPS, and EBITDA for Q2 were unavailable for GYRE via S&P Global at the time of this analysis; as such, comparisons to consensus and beat/miss assessments cannot be made (consensus unavailable; Values retrieved from S&P Global).*
Given the product launch trajectory and pivotal data, we expect future coverage to broaden; current lack of estimates reduces near‑term sell‑side anchoring.

Key Takeaways for Investors

Mix shift underway: New launches (Etorol, Contiva) are incrementally offsetting ETUARY® pressures; expect 2H revenue acceleration from broader commercialization and launch ramp .
Hydronidone pivotal data is a material catalyst with high statistical significance and favorable safety; NDA submission in China and U.S. Phase 2 initiation are near‑term inflection points for valuation .
Margins compressed QoQ due to higher operating expenses; watch selling and marketing investment intensity as launches scale, and G&A as public‑company costs normalize .
Liquidity improved meaningfully post equity offering; cash, equivalents, and deposits reached $75.9M—providing runway to execute commercial ramp and U.S. clinical plans .
Leadership transition aligns execution with pipeline expansion; interim CEO emphasizes global footprint and operational acceleration, reducing key person risk amid growth .
Macro in China and IPF competition remain headwinds to ETUARY®; sustained progress in new indications and products is critical to diversify revenue .
With no available Street estimates, trading may be more catalyst‑driven: near‑term focus on NMPA NDA filing, any regulatory feedback, and initiation of U.S. MASH Phase 2; monitoring further product sales trajectories will be key for 2H guide confidence .

GYRE THERAPEUTICS, INC. (GYRE)·Q2 2025 Earnings Summary