Gyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Gyre Therapeutics (NASDAQ: GYRE) reported its Q4 and full year 2024 financial results, highlighting key developments in both commercial and clinical portfolios. The company generated $105.8 million in revenue for 2024, down from $113.5 million in 2023, primarily due to decreased ETUARY sales.
Key highlights include:
- Pivotal Phase 3 trial data in CHB-associated liver fibrosis expected in Q2 2025
- Planned commercial launch of nintedanib for IPF and avatrombopag for CLD-associated thrombocytopenia in 2025
- Full year 2025 revenue guidance of $118-128 million, projecting 11.3-20.8% growth
- Cash position of $51.2 million as of December 31, 2024
For Q4 2024, the company reported net income of $0.6 million, compared to a $101.0 million loss in Q4 2023. Full-year 2024 net income was $17.9 million, versus an $85.5 million loss in 2023.
Gyre Therapeutics (NASDAQ: GYRE) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando sviluppi chiave nei portafogli commerciale e clinico. L'azienda ha generato 105,8 milioni di dollari di fatturato per il 2024, in calo rispetto ai 113,5 milioni di dollari del 2023, principalmente a causa della diminuzione delle vendite di ETUARY.
I punti salienti includono:
- Dati della fase 3 cruciale sulla fibrosi epatica associata all'HBV attesi nel secondo trimestre del 2025
- Lancio commerciale pianificato di nintedanib per l'IPF e avatrombopag per la trombocitopenia associata a CLD nel 2025
- Previsioni di fatturato per l'intero anno 2025 comprese tra 118 e 128 milioni di dollari, con una crescita prevista del 11,3-20,8%
- Posizione di cassa di 51,2 milioni di dollari al 31 dicembre 2024
Per il quarto trimestre del 2024, l'azienda ha riportato un utile netto di 0,6 milioni di dollari, rispetto a una perdita di 101,0 milioni di dollari nel quarto trimestre del 2023. L'utile netto per l'intero anno 2024 è stato di 17,9 milioni di dollari, contro una perdita di 85,5 milioni di dollari nel 2023.
Gyre Therapeutics (NASDAQ: GYRE) informó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando desarrollos clave en sus carteras comercial y clínica. La compañía generó 105,8 millones de dólares en ingresos para 2024, una disminución respecto a los 113,5 millones de dólares en 2023, principalmente debido a la disminución de las ventas de ETUARY.
Los aspectos destacados incluyen:
- Datos del ensayo pivotal de fase 3 sobre la fibrosis hepática asociada al CHB que se esperan en el segundo trimestre de 2025
- Lanzamiento comercial planeado de nintedanib para la FPI y avatrombopag para la trombocitopenia asociada a CLD en 2025
- Guía de ingresos para el año completo 2025 de 118 a 128 millones de dólares, proyectando un crecimiento del 11,3-20,8%
- Posición de efectivo de 51,2 millones de dólares al 31 de diciembre de 2024
Para el cuarto trimestre de 2024, la compañía reportó un ingreso neto de 0,6 millones de dólares, en comparación con una pérdida de 101,0 millones de dólares en el cuarto trimestre de 2023. El ingreso neto para el año completo 2024 fue de 17,9 millones de dólares, frente a una pérdida de 85,5 millones de dólares en 2023.
Gyre Therapeutics (NASDAQ: GYRE)는 2024년 4분기 및 연간 재무 결과를 발표하며 상업 및 임상 포트폴리오의 주요 발전 사항을 강조했습니다. 회사는 2024년 1억 580만 달러의 수익을 기록했습니다, 이는 2023년 1억 1350만 달러에서 감소한 수치로, 주로 ETUARY 판매 감소로 인한 것입니다.
주요 사항은 다음과 같습니다:
- 2025년 2분기에 예상되는 CHB 관련 간 섬유증에 대한 중요한 3상 시험 데이터
- 2025년 IPF용 닌테다닙 및 CLD 관련 혈소판 감소증용 아바트롬보팩 상업적 출시 계획
- 2025년 전체 수익 가이던스 1억 1800만~1억 2800만 달러, 11.3-20.8% 성장 예상
- 2024년 12월 31일 기준 현금 보유액 5120만 달러
2024년 4분기 동안 회사는 60만 달러의 순이익을 보고했으며, 이는 2023년 4분기 1억 1010만 달러의 손실과 비교됩니다. 2024년 전체 연간 순이익은 1790만 달러로, 2023년 8550만 달러의 손실과 대조됩니다.
Gyre Therapeutics (NASDAQ: GYRE) a publié ses résultats financiers du quatrième trimestre et de l'année 2024, mettant en avant des développements clés dans ses portefeuilles commercial et clinique. L'entreprise a généré 105,8 millions de dollars de revenus pour 2024, en baisse par rapport à 113,5 millions de dollars en 2023, principalement en raison de la baisse des ventes d'ETUARY.
Les points saillants incluent :
- Données d'essai cruciales de phase 3 sur la fibrose hépatique associée au CHB attendues au deuxième trimestre 2025
- Lancement commercial prévu de nintedanib pour l'IPF et d'avatrombopag pour la thrombocytopénie associée à la CLD en 2025
- Prévisions de revenus pour l'année complète 2025 entre 118 et 128 millions de dollars, projetant une croissance de 11,3 à 20,8%
- Position de trésorerie de 51,2 millions de dollars au 31 décembre 2024
Pour le quatrième trimestre 2024, l'entreprise a rapporté un bénéfice net de 0,6 million de dollars, contre une perte de 101,0 millions de dollars au quatrième trimestre 2023. Le bénéfice net pour l'année entière 2024 s'élevait à 17,9 millions de dollars, contre une perte de 85,5 millions de dollars en 2023.
Gyre Therapeutics (NASDAQ: GYRE) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei wichtige Entwicklungen in den kommerziellen und klinischen Portfolios hervorgehoben. Das Unternehmen erzielte 105,8 Millionen Dollar Umsatz für 2024, ein Rückgang von 113,5 Millionen Dollar im Jahr 2023, hauptsächlich aufgrund gesunkener ETUARY-Verkäufe.
Wichtige Highlights sind:
- Wichtige Phase-3-Studienergebnisse zur mit CHB assoziierten Leberfibrose, die im zweiten Quartal 2025 erwartet werden
- Geplanter Markteintritt von Nintedanib für IPF und Avatrombopag für CLD-assoziierte Thrombozytopenie im Jahr 2025
- Umsatzprognose für das gesamte Jahr 2025 zwischen 118 und 128 Millionen Dollar, was ein Wachstum von 11,3-20,8% prognostiziert
- Liquiditätsposition von 51,2 Millionen Dollar zum 31. Dezember 2024
Für das vierte Quartal 2024 meldete das Unternehmen einen Nettogewinn von 0,6 Millionen Dollar, verglichen mit einem Verlust von 101,0 Millionen Dollar im vierten Quartal 2023. Der Nettogewinn für das gesamte Jahr 2024 betrug 17,9 Millionen Dollar, im Vergleich zu einem Verlust von 85,5 Millionen Dollar im Jahr 2023.
- Net income improved to $17.9 million in 2024 from $85.5 million loss in 2023
- Projected revenue growth of 11.3-20.8% for 2025
- Two new product launches planned for 2025
- Strong cash position of $51.2 million
- Revenue declined 6.8% to $105.8 million in 2024 from $113.5 million in 2023
- ETUARY sales decreased by $7.1 million due to Chinese economic fluctuations
- Generic drug revenue decreased by $0.6 million
- Operating expenses increased due to public company costs
Insights
Gyre Therapeutics' financial results paint a picture of a company navigating through market headwinds while positioning for future growth. Despite full-year revenue declining 6.8% to $105.8 million from $113.5 million, the company has achieved a remarkable turnaround in profitability, posting net income of $17.9 million compared to an $85.5 million loss in 2023.
The revenue decline was attributed to economic fluctuations in China affecting demand for anti-fibrosis drugs and overall healthcare spending reduction. However, Q4 showed early signs of stabilization with revenue up 3% to
Looking forward, Gyre's 2025 revenue guidance of $118-128 million represents 11.3-20.8% growth, driven by two planned product launches. The company's
What's particularly notable is how Gyre improved profitability despite revenue challenges, suggesting enhanced operational efficiency and cost management. The
Gyre's clinical pipeline progression represents a significant near-term value driver alongside its commercial operations. The upcoming F351 Phase 3 data readout in Q2 2025 for CHB-associated liver fibrosis is particularly important as it will not only potentially unlock the Chinese market but also inform the planned U.S. Phase 2 trial in MASH-associated liver fibrosis.
The company's pipeline shows strategic diversification across multiple fibrotic conditions. Beyond F351, Gyre has advanced F573 (a caspase inhibitor for acute liver failure) through Phase 2, with completion expected by end of 2026. Their pulmonary program includes F230 (selective endothelin receptor agonist) entering Phase 1 for pulmonary arterial hypertension, while F528 (novel anti-inflammatory) advances in preclinical development for COPD.
On the commercial front, the planned 2025 launches of nintedanib and avatrombopag in China represent important near-term revenue opportunities. Nintedanib's approval across multiple indications (IPF, SSc-ILD, and PF-ILD) provides treatment options for related fibrotic conditions, while avatrombopag addresses thrombocytopenia in both chronic liver disease and ITP patients.
This dual approach of advancing novel clinical assets while expanding commercial products creates multiple potential inflection points. The company's established commercial infrastructure in China should facilitate the integration of these new products without proportional increases in selling expenses, potentially driving margin improvement in 2025.
Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025
Commercial launch in the PRC of generic nintedanib for the treatment of IPF and avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia expected in 2025
Initiation of U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis expected in 2025
Full year 2025 total revenue guidance of
SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update.
“2025 is shaping up to be a pivotal year for Gyre across both our commercial-stage and clinical-stage portfolios. We plan to expand and enhance our commercial product offerings through the additions of nintedanib for IPF, SSc-ILD and PF-ILD, as well as avatrombopag for CLD-associated thrombocytopenia and chronic idiopathic thrombocytopenia (“ITP”). Given our proven track record and extensive sales and marketing platform, we are confident in our ability to successfully launch and expand these two products in the PRC,” said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. “In parallel, 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.”
Full Year 2024 Business Highlights and Upcoming Milestones
Commercial-Stage Updates
- ETUARY (Pirfenidone) sales update: For the year ended December 31, 2024, Gyre Pharmaceuticals generated
$105.0 million primarily in sales of ETUARY. - Nintedanib: In May 2024, Gyre Pharmaceuticals executed a comprehensive agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. to obtain the drug registration certificate for and became the marketing authorization holder of nintedanib, the other product approved for the treatment of treatment of idiopathic pulmonary fibrosis (“IPF”). In addition, it has also been approved for the treatment of SSc-ILD and PF-ILD. Gyre Pharmaceuticals plans to initiate commercialization of the nintedanib product in the PRC in 2025.
- Avatrombopag: In June 2024, Gyre Pharmaceuticals received approval from China’s National Medical Products Administration (“NMPA”) for avatrombopag maleate tablets for the treatment of thrombocytopenia associated with chronic liver disease (“CLD”) and chronic idiopathic thrombocytopenia (“ITP”) in adult patients undergoing elective diagnostics procedures or therapy. Gyre Pharmaceuticals plans to begin commercialization of avatrombopag in 2025.
Pipeline Development Updates
F351 (Hydronidone):
- All patients completed 52-week pivotal Phase 3 trial in chronic hepatitis B (“CHB”)-associated liver fibrosis in the PRC. In October 2024, Gyre Pharmaceuticals announced the last patient completed the 52-week pivotal Phase 3 trial. The trial is evaluating 248 patients with CHB-associated liver fibrosis in the PRC with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one stage after taking F351 in combination with entecavir. Gyre expects to report topline data in the second quarter of 2025.
- Plans to initiate a Phase 2 clinical trial in metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis in 2025. Pending the results from the pivotal Phase 3 trial in CHB-associated liver fibrosis, Gyre intends to initiate a Phase 2 proof-of-concept trial in the U.S. to evaluate F351 for the treatment of MASH-associated liver fibrosis in 2025.
F573:
- F573 is a caspase inhibitor and a potential Category 1 new drug for the treatment of acute/acute on-chronic liver failure (“ALF/ACLF”). Completion of the Phase 2 clinical trial of F573 as a treatment for ALF/ACLF is expected by the end of 2026.
F230:
- F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension (“PAH”), is expected to begin a Phase 1 trial in 2025.
F528:
- F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre plans to submit an IND application in 2026.
Corporate Updates
- In January 2025, appointed Ping Zhang to the Company’s Board of Directors as the lead independent director and member of the Nominating Committee. In addition, Ying Luo, Ph.D., resigned as Chairman and member of the Board of Directors of Gyre and Gyre Pharmaceuticals, Gyre’s majority indirectly owned subsidiary in the People’s Republic of China (“PRC”), to focus on other responsibilities at GNI Group Ltd. Songjiang Ma has been appointed Chairman of the Board of Directors of Gyre Pharmaceuticals.
Financial Results
Cash Position
As of December 31, 2024, Gyre had cash, cash equivalents, short-term and long-term bank deposits of
Financial Results for the Three Months Ended December 31, 2024
- Revenues: Revenues for the three months ended December 31, 2024 were
$27.9 million , compared to$27.1 million for the same period in 2023. The$0.8 million increase was primarily driven by a$1.0 million increase in ETUARY's revenue and a$0.2 million decrease in generic drug revenue. The growth in ETUARY sales was attributed to the active expansion of the IPF treatment market, increased market penetration, and a stronger focus on ETUARY sales. To support future revenue growth, Gyre Pharmaceuticals plans to commercially launch two new products, nintedanib and avatrombopag, in 2025, which will be supported by its extensive sales and marketing platform in the PRC. - Cost of Revenues: For the three months ended December 31, 2024, cost of revenues was
$1.2 million , compared to$1.3 million for the same period in 2023. The$0.1 million decrease was primarily driven by a$0.2 million decrease in generic drug cost due to the decrease in sales and a$0.1 million decrease in factory stoppage loss due to factory renovation in 2023, offset by a$0.2 million increase due to the increase of ETUARY's cost due to the increase in sales. - Selling and Marketing Expense: For the three months ended December 31, 2024, selling and marketing expense was
$16.9 million , compared to$16.5 million for the same period in 2023. The increase was primarily driven by a$2.1 million increase in promotion expense and conference expenses, offset by a$1.1 million decrease in selling and marketing payroll costs, a$0.3 million decrease in stock-based compensation expense and a$0.3 million decrease in travel and miscellaneous expenses. - Research and Development Expense: For the three months ended December 31, 2024, research and development expense was
$3.7 million , compared to$4.6 million for the same period in 2023. The decrease was primarily driven by a$0.5 million decrease in pre-clinical and clinical research expenses and a$0.5 million decrease in stock-based compensation expense, offset by a$0.1 million increase in miscellaneous expense. - General and Administrative Expense: For the three months ended December 31, 2024, general and administrative expense was
$5.5 million , compared to$10.1 million for the same period in 2023. The decrease was primarily driven by a$5.8 million decrease in stock-based compensation cost, offset by a$0.8 million increase in the functional and administrative department's personnel cost and a$0.4 million increase in professional expense, including legal and consulting fees. - Income (Loss) from Operations: For the three months ended December 31, 2024, income from operations was
$0.7 million , compared to$91.1 million loss from operation for the same period in 2023. The increase in income from operations was driven primarily by acquired in-process research and development expense recognized in the fourth quarter of 2023 and there was no such expense in the same period in 2024. - Net Income (Loss): For the three months ended December 31, 2024, net income was
$0.6 million , compared to$101.0 million net loss for the same period in 2023. - Non-GAAP Adjusted Net Income: For the three months ended December 31, 2024, non-GAAP adjusted net income was
$1.1 million , compared to$2.1 million for the same period in 2023. The decrease was primarily driven by the costs of being a public company for three months in 2024, as compared to two months in 2023.
Financial Results for the Full Year Ended December 31, 2024
- Revenues: Revenues for the full year ended December 31, 2024 were
$ 105.8 million , compared to$113.5 million for the same period in 2023. The$7.7 million decrease was primarily driven by a$7.1 million decrease in ETUARY's revenue and a$0.6 million decrease in generic drug revenue as a result of decreased sales volumes. The decrease in ETUARY and generic drug sales volumes was due to fluctuations in the Chinese economy that significantly affected demand for anti-fibrosis drugs and decreasing healthcare spending generally. To support future revenue growth, Gyre plans to commercially launch two new products, nintedanib and avatrombopag, in 2025, which will be supported by Gyre Pharmaceuticals' extensive sales and marketing platform across the PRC. - Cost of Revenues: For the full year ended December 31, 2024, cost of revenues was
$3.9 million , compared to$4.6 million for the same period in 2023. The$0.7 million decrease was primarily driven by a$0.5 million factory stoppage loss due to factory renovation in 2023, which did not occur in 2024, and a$0.2 million decrease due to decreased sales volumes. - Selling and Marketing Expense: For the full year ended December 31, 2024, selling and marketing expense was
$57.5 million , compared to$61.2 million for the same period in 2023. The decrease was primarily driven by a$2.4 million decrease in conference costs and promotion expense due to decreased sales activities, a$0.9 million decrease in selling and marketing payroll costs due to the decrease of sales of ETUARY in 2024, a$0.3 million decrease in share base compensation expense, and a$0.1 million decrease in miscellaneous expenses. - Research and Development Expense: For the full year ended December 31, 2024, research and development expense was
$12.0 million , compared to$13.8 million for the same period in 2023. The decrease was primarily from Gyre Pharmaceuticals, and was driven by a$0.3 million decrease in materials and utilities, a$1.3 million decrease in pre-clinical research expense due to several research and development projects advancing to the clinical trials stage or reaching the application phase in 2024, and a$0.4 million decrease in staff cost due to reduced headcount, and a$0.5 million decrease in stock-based compensation, related to options being fully vested in 2023, which did not occur in 2024, This overall decrease was partially offset by a 0.7 million increase in general research and development expense from Gyre Therapeutics due to increased consulting fees. - General and Administrative Expense: For the full year ended December 31, 2024, general and administrative expense was
$16.1 million , compared to$14.7 million for the same period in 2023. The increase was primarily driven by costs associated with being a public company, including a$1.9 million increase in professional expense, a$2.1 million increase in miscellaneous expenses and a$3.0 million increase in the functional and administrative department's personnel cost, offset by a$5.6 million decrease in stock-based compensation cost. - Income (loss) from Operations: For the full year ended December 31, 2024, income from operations was
$16.2 million , compared to$67.2 million loss for the same period in 2023. The increase in income from operations was driven primarily by acquired in-process research and development expense recognized in 2023 and there was no such expense in the same period in 2024. - Net Income (loss): For the full year ended December 31, 2024, net income was
$17.9 million , compared to$85.5 million net loss for the same period in 2023. - Non-GAAP Adjusted Net Income: For the full year ended December 31, 2024, non-GAAP adjusted net income was
$16.9 million , compared to$25.4 million for the same period in 2023. The decrease was primarily driven by a$7.7 million decline in revenue and a$1.1 million increase in operating expenses. Despite these changes, the gross profit margin remained consistent.
Full Year 2025 Financial Guidance
For the full year 2025, the Company expects to generate revenues of
Guidance Range | |
Total Revenue | |
Please note the following regarding the total revenue guidance:
- Guidance assumes a constant foreign currency exchange rate.
- Guidance assumes no significant economic disruption or downturn.
Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.
About Hydronidone (F351)
F351 is a structural analogue of the approved anti-fibrotic (IPF) drug Pirfenidone and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (“HSCs”), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of MASH fibrosis (CCI4+Western High Fat Diet).
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company's experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC, initiation of Gyre’s Phase 2 trial in the U.S. for F351 for the treatment of MASH-associated liver fibrosis, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, initiation of Phase 1 trial of F230 for the treatment of PAH and IND submission of F528 in COPD, the expectations regarding commercial launch of nintedanib and avatrombopag maleate tablets, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 27, 2024 and in other filings with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
For Investors:
Stephen Jasper
stephen@gilmartinir.com
Gyre Therapeutics, Inc. | |||||||||||||||
Consolidated Statements of Operations | |||||||||||||||
(In thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended December 31, (Unaudited) | Year Ended December 31, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Revenues | $ | 27,872 | $ | 27,148 | $ | 105,757 | $ | 113,450 | |||||||
Operating expenses: | |||||||||||||||
Cost of revenues | 1,177 | 1,250 | 3,884 | 4,636 | |||||||||||
Selling and marketing | 16,856 | 16,464 | 57,511 | 61,159 | |||||||||||
Research and development | 3,712 | 4,568 | 12,024 | 13,780 | |||||||||||
General and administrative | 5,464 | 10,055 | 16,109 | 14,662 | |||||||||||
Acquired in-process research and development | — | 83,104 | — | 83,104 | |||||||||||
Divestiture losses | — | 2,711 | — | 2,711 | |||||||||||
Loss on disposal of property and equipment | (2 | ) | 102 | 66 | 628 | ||||||||||
Total operating expenses | 27,207 | 118,254 | 89,594 | 180,680 | |||||||||||
Income (loss) from operations | 665 | (91,106 | ) | 16,163 | (67,230 | ) | |||||||||
Other income (expense), net: | |||||||||||||||
Interest income, net | 346 | 326 | 1,547 | 1,044 | |||||||||||
Other expense, net | (433 | ) | (237 | ) | (1,659 | ) | (1,518 | ) | |||||||
Change in fair value of warrant liability | 194 | (9,261 | ) | 7,167 | (9,261 | ) | |||||||||
Income (loss) before income taxes | 772 | (100,278 | ) | 23,218 | (76,965 | ) | |||||||||
Provision for income taxes | (203 | ) | (699 | ) | (5,320 | ) | (8,515 | ) | |||||||
Net income (loss) | 569 | (100,977 | ) | 17,898 | (85,480 | ) | |||||||||
Net income attributable to noncontrolling interest | 668 | 29 | 5,813 | 7,453 | |||||||||||
Net income (loss) attributable to common stockholders | $ | (99 | ) | $ | (101,006 | ) | $ | 12,085 | $ | (92,933 | ) | ||||
Net income (loss) per share attributable to common stockholders: | |||||||||||||||
Basic | $ | (0.00 | ) | $ | (1.39 | ) | $ | 0.14 | $ | (1.41 | ) | ||||
Diluted | $ | (0.00 | ) | $ | (1.39 | ) | $ | 0.05 | $ | (1.41 | ) | ||||
Weighted average shares used in calculating net income (loss) per share attributable to common stockholders: | |||||||||||||||
Basic | 85,952,413 | 72,489,183 | 85,094,948 | 65,831,675 | |||||||||||
Diluted | 85,952,413 | 72,489,183 | 102,293,526 | 65,831,675 | |||||||||||
Gyre Therapeutics, Inc. | |||||||
Consolidated Balance Sheets | |||||||
(In thousands, except share and per share amounts) | |||||||
December 31, 2024 | December 31, 2023 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 11,813 | $ | 33,509 | |||
Short-term bank deposits | 14,858 | — | |||||
Notes receivable | 4,373 | 389 | |||||
Accounts receivable, net | 19,589 | 15,163 | |||||
Other receivables from GNI | 230 | 1,287 | |||||
Inventories, net | 6,337 | 4,281 | |||||
Prepaid assets | 1,189 | 1,547 | |||||
Receivable from GCBP | 4,961 | — | |||||
Other current assets | 1,436 | 1,045 | |||||
Total current assets: | 64,786 | 57,221 | |||||
Property and equipment, net | 23,880 | 23,288 | |||||
Long-term receivable from GCBP | — | 4,722 | |||||
Intangible assets, net | 273 | 205 | |||||
Right-of-use assets | 1,818 | 489 | |||||
Land use rights, net | 1,432 | 1,493 | |||||
Deferred tax assets | 5,619 | 4,695 | |||||
Long-term certificates of deposit | 24,568 | 23,431 | |||||
Other assets, noncurrent | 3,030 | 995 | |||||
Total assets | $ | 125,406 | $ | 116,539 | |||
Liabilities, convertible preferred stock, and equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 108 | $ | 355 | |||
Contract liabilities | 61 | 39 | |||||
Due to related parties | 227 | 1,369 | |||||
CVR excess closing cash payable | — | 1,085 | |||||
Accrued expenses and other current liabilities | 10,615 | 11,935 | |||||
Income tax payable | 2,831 | 5,054 | |||||
Operating lease liabilities, current | 713 | 210 | |||||
CVR derivative liability | 4,961 | — | |||||
Total current liabilities: | 19,516 | 20,047 | |||||
Operating lease liabilities, noncurrent | 885 | 199 | |||||
Deferred government grants | 928 | 213 | |||||
CVR derivative liability, noncurrent | — | 4,722 | |||||
Warrant liability, noncurrent | 5,668 | 12,835 | |||||
Other noncurrent liabilities | 7 | 49 | |||||
Total liabilities | $ | 27,004 | $ | 38,065 | |||
Commitments and Contingencies | |||||||
Convertible Preferred Stock, | — | 64,525 | |||||
Equity: | |||||||
Common stock, | 86 | 77 | |||||
Additional paid-in capital | 136,185 | 68,179 | |||||
Statutory reserve | 3,098 | 3,098 | |||||
Accumulated deficit | (73,453 | ) | (85,538 | ) | |||
Accumulated other comprehensive loss | (2,597 | ) | (1,644 | ) | |||
Total Gyre stockholders’ equity (deficit) | 63,319 | (15,828 | ) | ||||
Noncontrolling interest | 35,083 | 29,777 | |||||
Total equity | 98,402 | 13,949 | |||||
Total liabilities, convertible preferred stock, and equity | $ | 125,406 | $ | 116,539 | |||
Gyre Therapeutics, Inc. | |||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures | |||||||||||||||
(in thousands) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended December 31, | Years Ended December 31, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Net income (loss) | $ | 569 | $ | (100,977 | ) | $ | 17,898 | $ | (85,480 | ) | |||||
Acquired in-process research and development (1) | — | 83,104 | — | 83,104 | |||||||||||
(Gain) loss from change in fair value of warrants (2) | (194 | ) | 9,261 | (7,167 | ) | 9,261 | |||||||||
Stock-based compensation | 567 | 7,281 | 831 | 7,281 | |||||||||||
Divestiture losses (3) | — | 2,711 | — | 2,711 | |||||||||||
Provision for income taxes | 203 | 699 | 5,320 | 8,515 | |||||||||||
Non-GAAP adjusted net income | $ | 1,145 | $ | 2,079 | $ | 16,882 | $ | 25,392 | |||||||
(1) Reflects adjustments for a reverse asset acquisition with CPI as the accounting acquirer and Catalyst as the legal acquirer.
(2) Reflects adjustments for fair value of warrants based on the Black-Sholes option pricing model.
(3) Reflects adjustments loss from the divestiture of all assets other than
