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Gyre Therapeutics Reports Third Quarter 2024 and Year-To-Date Financial Results and Provides Business Update

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Gyre Therapeutics (NASDAQ: GYRE) reported Q3 2024 financial results with revenues of $25.5 million, down from $32.0 million in Q3 2023. The company completed its pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis, with data expected in Q1 2025. Key developments include planned commercial launches of avatrombopag and nintedanib in 2025, and preparations for a U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis. The company reported Q3 net income of $2.9 million, down from $7.5 million in Q3 2023, with cash and equivalents of $15.9 million as of September 30, 2024.

Gyre Therapeutics (NASDAQ: GYRE) ha riportato i risultati finanziari del terzo trimestre 2024 con ricavi di 25,5 milioni di dollari, in calo rispetto ai 32,0 milioni di dollari del terzo trimestre 2023. L'azienda ha completato il suo importante studio di fase 3 per F351 nella fibrosi epatica associata a CHB, con dati attesi nel primo trimestre del 2025. Sviluppi chiave includono il lancio commerciale previsto di avatrombopag e nintedanib nel 2025, e i preparativi per uno studio di fase 2 negli Stati Uniti di F351 nella fibrosi epatica associata a MASH. L'azienda ha riportato un reddito netto di 2,9 milioni di dollari nel terzo trimestre, in calo rispetto ai 7,5 milioni di dollari del terzo trimestre 2023, con liquidità e equivalenti di 15,9 milioni di dollari al 30 settembre 2024.

Gyre Therapeutics (NASDAQ: GYRE) informó los resultados financieros del tercer trimestre de 2024 con ingresos de 25.5 millones de dólares, una disminución respecto a los 32.0 millones de dólares en el tercer trimestre de 2023. La compañía completó su ensayo pivotal de fase 3 para F351 en la fibrosis hepática asociada a CHB, con datos esperados para el primer trimestre de 2025. Desarrollos clave incluyen lanzamientos comerciales planificados de avatrombopag y nintedanib en 2025, y preparativos para un ensayo de fase 2 en EE. UU. de F351 en la fibrosis hepática asociada a MASH. La compañía reportó un ingreso neto de 2.9 millones de dólares en el tercer trimestre, en comparación con los 7.5 millones de dólares en el tercer trimestre de 2023, con efectivo y equivalentes de 15.9 millones de dólares al 30 de septiembre de 2024.

Gyre Therapeutics (NASDAQ: GYRE)는 2024년 3분기 재무 결과를 발표하면서 수익이 2,550만 달러로, 2023년 3분기의 3,200만 달러에서 감소했다고 보고했습니다. 이 회사는 CHB 관련 간 섬유증을 위한 F351의 주요 3상 시험을 완료하였으며, 2025년 1분기에 데이터가 예상됩니다. 주요 개발 사항으로는 2025년에 avatrombopag 및 nintedanib의 상업 출시 계획과 MASH 관련 간 섬유증에서 F351의 미국 2상 시험 준비가 포함됩니다. 회사는 2024년 9월 30일 기준으로 현금 및 현금성 자산이 1,590만 달러인 3분기 순이익이 290만 달러로, 2023년 3분기의 750만 달러에서 감소했다고 보고했습니다.

Gyre Therapeutics (NASDAQ: GYRE) a annoncé les résultats financiers du troisième trimestre 2024 avec des revenus de 25,5 millions de dollars, en baisse par rapport à 32,0 millions de dollars au troisième trimestre 2023. L'entreprise a terminé son essai pivot de phase 3 pour F351 dans la fibrose hépatique associée à CHB, avec des données attendues pour le premier trimestre 2025. Données clés incluent des lancements commerciaux prévus d'avatrombopag et de nintedanib en 2025, ainsi que des préparatifs pour un essai de phase 2 aux États-Unis de F351 dans la fibrose hépatique associée à MASH. L'entreprise a rapporté un revenu net de 2,9 millions de dollars au troisième trimestre, en baisse par rapport à 7,5 millions de dollars au troisième trimestre 2023, avec des liquidités et des équivalents de 15,9 millions de dollars au 30 septembre 2024.

Gyre Therapeutics (NASDAQ: GYRE) berichtete über die finanziellen Ergebnisse des 3. Quartals 2024 mit einem Umsatz von 25,5 Millionen Dollar, was einem Rückgang von 32,0 Millionen Dollar im 3. Quartal 2023 entspricht. Das Unternehmen hat seine entscheidende Phase-3-Studie für F351 bei CHB-assoziierter Leberfibrose abgeschlossen, mit Daten, die im 1. Quartal 2025 erwartet werden. Wichtige Entwicklungen umfassen geplante Markteinführungen von Avatrombopag und Nintedanib im Jahr 2025 sowie Vorbereitungen für eine Phase-2-Studie von F351 in der USA bei MASH-assoziierter Leberfibrose. Das Unternehmen berichtete im 3. Quartal von einem Nettogewinn von 2,9 Millionen Dollar, ein Rückgang von 7,5 Millionen Dollar im 3. Quartal 2023, mit liquiden Mitteln und Äquivalenten in Höhe von 15,9 Millionen Dollar zum 30. September 2024.

Positive
  • Completed Phase 3 trial for F351 with 248 patients
  • Received NMPA approval for avatrombopag maleate tablets
  • Maintained profitability with Q3 net income of $2.9 million
  • Generated $25.3 million in ETUARY sales for Q3 2024
  • Cash position of $15.9 million sufficient for 12+ months of operations
Negative
  • Q3 revenue declined 20.3% YoY from $32.0M to $25.5M
  • Q3 net income decreased 61.3% YoY from $7.5M to $2.9M
  • Operating income dropped 67.2% YoY from $12.8M to $4.2M
  • G&A expenses increased significantly from $1.2M to $3.8M
  • Anti-fibrosis drug sales decreased due to Chinese economy fluctuations

Insights

Key financial metrics reveal mixed performance with concerning trends. Revenue declined 20.3% to $25.5M in Q3, primarily due to weakening anti-fibrosis drug sales in China. Operating income dropped significantly from $12.8M to $4.2M, a 67.2% decrease. The cash position of $15.9M appears tight given the planned commercial launches and clinical trials.

However, positive catalysts are on horizon with two commercial launches in 2025 - avatrombopag and nintedanib. The completion of F351's Phase 3 trial with data expected in Q1 2025 represents a major milestone. The company's strategy to diversify revenue streams through new product launches could help offset current market pressures.

The clinical pipeline shows promising developments across multiple indications. The completed Phase 3 trial for F351 in CHB-associated liver fibrosis with 248 patients represents a significant advancement. The expansion into MASH-associated liver fibrosis demonstrates strategic diversification of the platform. The preclinical portfolio, particularly F230 for PAH and F528 for COPD, indicates strong potential for long-term growth.

The commercial portfolio strengthening with avatrombopag for thrombocytopenia and nintedanib for IPF provides near-term revenue opportunities. These additions complement the existing ETUARY franchise and position Gyre as a stronger player in specialty pharmaceuticals.

Last patient completed pivotal Phase 3 trial in CHB-associated liver fibrosis in the PRC with data expected in Q1 2025

On track to initiate U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis in 2025

Commercial launch of avatrombopag maleate tablets expected by the first half of 2025

Commercial launch of nintedanib expected in 2025

Cash and cash equivalents totaled $15.9 million as of September 30, 2024

SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced financial results for the third quarter and nine months ended September 30, 2024, and provided a business update.

“Our team has made great progress over the last several months and recently achieved a significant milestone with the final patient completing 52 weeks of study in our pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis. We are encouraged by F351’s potential as a novel treatment for this fibrotic disease and are excited to share topline results in the first quarter 2025,” said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. “With several upcoming milestones in 2025, including the commercial launch of two new products in the PRC as well as the anticipated initiation of a U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis, we remain confident in Gyre’s ability to deliver in the clinic and the commercial market for patients in need.”

Third Quarter 2024 Business Highlights and Upcoming Milestones

Commercial-Stage Updates

  • ETUARY (Pirfenidone) sales update: For the quarter ended September 30, 2024, Gyre Pharmaceuticals, Gyre’s majority indirectly owned subsidiary in the People’s Republic of China (“PRC”), generated $25.3 million in sales of ETUARY.
  • 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”) in adult patients undergoing elective diagnostics procedures or therapy. This approval expands Gyre’s rare disease product lines and provides a treatment option for a common and potentially life-threatening hematologic complication in patients with CLD. Gyre anticipates launching avatrombopag in the PRC in the first half of 2025 and plans to leverage its existing extensive sales and marketing platform.
  • Nintedanib: Gyre Pharmaceuticals is planning to start commercializing nintedanib, a small-molecule drug for the treatment of idiopathic pulmonary fibrosis ("IPF"), which was acquired from Jiangsu Wangao Pharmaceuticals Co., Ltd., in the PRC in 2025. Nintedanib is the other product approved for the treatment of IPF, which is currently approved globally for the treatment of IPF. Nintedanib is expected to provide patients more choices and benefits, and further enhance Gyre Pharmaceuticals’ leading position in the pulmonary fibrosis market.

Clinical Development Updates

F351 (Hydronidone):

  • All patients completed 52-week Phase 3 trial evaluating F351 for the treatment of Chronic Hepatitis B (“CHB”)-associated liver fibrosis. In October 2024, Gyre Pharmaceuticals announced the final patient had completed the 52-week pivotal Phase 3 trial in patients with CHB-associated liver fibrosis in the PRC. The trial evaluated 248 patients 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 Pharmaceuticals remains on track to report topline data in the first 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 PRC Phase 3 trial in CHB-associated liver fibrosis, Gyre intends to initiate a Phase 2 proof-of-concept clinical trial to evaluate F351 for the treatment of MASH-associated liver fibrosis in 2025.

F573:

  • Ongoing Phase 2 trial in the PRC. Gyre Pharmaceuticals is conducting a randomized, double-blind, placebo-controlled Phase 2 clinical trial in the PRC to assess the safety and efficacy of F573, a caspase inhibitor for injection in the treatment of acute/acute on-chronic liver failure.

Preclinical Development Updates

  • F230: F230 is a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension (“PAH”). In May 2024, Gyre Pharmaceuticals received NMPA approval for its Investigational New Drug (“IND”) application to evaluate for F230 tablets for the treatment of PAH and expects to initiate a Phase 1 trial in 2025.
  • F528: F528 is a novel anti-inflammation agent that targets the inhibition of multiple inflammatory cytokines and has the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”) with low toxicity in vivo. Gyre Pharmaceuticals is evaluating F528 in preclinical studies as a potential first-line therapy for the treatment of COPD.

Corporate Updates

  • In August 2024, Gyre announced the appointment of David M. Epstein, Ph.D., to its Board of Directors. Dr. Epstein has extensive global experience in biotech companies across the United States and Asia. Dr. Epstein is a co-founder of PairX Bio Pte. Ltd., where he currently serves as director, President and Chief Executive Officer. Dr. Epstein co-founded and served as President and Chief Executive Officer of Black Diamond Therapeutics, leading the company through its January 2020 IPO. Prior to Black Diamond, Dr. Epstein was Vice Dean, Innovation & Entrepreneurship and Associate Professor at Duke-NUS Medical School in Singapore.

Financial Results

Cash Position

As of September 30, 2024, Gyre had cash and cash equivalents of $15.9 million. Based on current plans, Gyre anticipates that its cash resources as of September 30, 2024 will enable it to fund operations through at least 12 months following the issuance of the condensed financial statements.

Financial Results for the Three Months Ended September 30, 2024

  • Revenues: Revenues for the three months ended September 30, 2024 were $25.5 million, compared to $32.0 million for the same period in 2023. The $6.5 million decrease was primarily driven by a $6.4 million decrease in anti-fibrosis drug sales and a $0.1 million decrease in generic drug sales due to fluctuations in the Chinese economy significantly affecting demand for anti-fibrosis drugs and decreasing healthcare spending generally. To support future revenue growth, we plan to commercially launch new products, such as nintedanib and avatrombopag, in early 2025, which will be supported by our extensive sales and marketing platform across the PRC.
  • Cost of Revenues: For the three months ended September 30, 2024, cost of revenues was $1.0 million, compared to $1.2 million for the same period in 2023. The decrease was primarily driven by a $0.1 million factory stoppage loss due to factory renovation in 2023 and a $0.1 million decrease in sales quantity.
  • Selling & Marketing Expense: For the three months ended September 30, 2024, selling and marketing expense was $13.7 million, compared to $13.9 million for the same period in 2023. The decrease was primarily driven by a $0.9 million decrease in conference costs due to a decrease in conference activity, a $0.9 million decrease in staff cost as well as a $0.1 million decrease in other expenses, partially offset by a $1.5 million increase in promotional expenses and a $0.2 million increase in travel expense.
  • R&D Expense: For the three months ended September 30, 2024, research and development expense was $2.8 million, compared to $3.0 million for the same period in 2023. The decrease was primarily from Gyre Pharmaceuticals, and was driven by a $0.5 million decrease in pre-clinical research expense and a $0.2 million decrease in staff cost due to the decrease in headcount in the research and development department, partially offset by a $0.5 million increase in our clinical trial expense and clinical trial expense from Gyre Pharmaceuticals.
  • G&A Expense: For the three months ended September 30, 2024, general and administrative expense was $3.8 million, compared to $1.2 million for the same period in 2023. The increase was primarily driven by costs associated with being a public company, including a $0.9 million increase in functional and administrative department's personnel and stock compensation costs, a $0.6 million increase in miscellaneous expenses, and a $1.2 million increase in professional expense.
  • Income from operations: For the three months ended September 30, 2024, income from operations was $4.2 million, compared to $12.8 million for the same period in 2023.
  • Net Income: For the three months ended September 30, 2024, net income was $2.9 million, compared to $7.5 million in net income for the same period in 2023.

Financial Results for the Nine Months Ended September 30, 2024

  • Revenues: For the nine months ended September 30, 2024, revenue was $77.9 million, compared to $86.3 million for the same period in 2023. The $8.4 million decrease was primarily driven by a $8.0 million decrease in anti-fibrosis drug sales and a $0.4 million decrease in generic drugs due to the same factors mentioned above. If approved by the NMPA for commercial use, we expect that F351 for the treatment of CHB-associated liver fibrosis in the PRC will support revenue growth in the future, which will be supported by our extensive sales and marketing platform across the PRC.
  • Cost of Revenues: For the nine months ended September 30, 2024, cost of revenues was $2.7 million, compared to $3.4 million for the same period in 2023. The decrease was primarily driven by a $0.4 million factory stoppage loss due to factory renovation in 2023, and a $0.4 million decrease in generic drug cost due to the decrease of sales, offset by a $0.1 million increase of the staff cost and new equipment depreciation.
  • Selling & Marketing Expense: For the nine months ended September 30, 2024, selling and marketing expense was $40.7 million, compared to $44.7 million for the same period in 2023. The decrease was primarily driven by a $5.3 million decrease in conference costs due to a decrease in conference activity, partially offset by a $1.0 million increase in promotional expenses, a $0.2 million increase in staff costs due to an increase in staff headcount, and a $0.1 million increase in other expenses.
  • R&D Expense: For the nine months ended September 30, 2024, research and development expense was $8.3 million, compared to $9.2 million for the same period in 2023. The $1.5 million decrease from Gyre Pharmaceuticals was primarily driven by a $1.0 million decrease in pre-clinical research expenses, a $0.3 million decrease in materials and utilities, and a $0.2 million decrease in staff cost due to the decrease in headcount in the research and development department. These decreases were offset by a $0.6 million increase in our clinical trial costs and research and development consulting costs.
  • G&A Expense: For the nine months ended September 30, 2024, general and administrative expense was $10.6 million, compared to $4.6 million for the same period in 2023. The increase was primarily driven by costs associated with being a public company, including a $2.9 million increase in functional and administrative department’s personnel and stock compensation costs, a $1.8 million increase in miscellaneous expenses, and a $1.3 million increase in professional expense.
  • Income from operations: For the nine months ended September 30, 2024, income from operations was $15.6 million, compared to $24.4 million for the same period in 2023.
  • Net Income: For the nine months ended September 30, 2024, net income was $17.3 million, compared to $15.5 million for the same period in 2023.

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 (2023 net sales of $112.1 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by early 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).

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, the U.S. IND submission of F351 in MASH-associated liver fibrosis, initiation of Gyre’s Phase 2 trial and comprehensive Phase 2/3 clinical program in the U.S. for F351, timing of topline results from Phase 2 clinical trial in the PRC of F573 for acute/acute on-chronic liver failure and initiation of Phase 1 trial of F230 for the treatment of PAH, the expectations regarding generic drug nintedanib, the anticipated commercial launch of 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.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
 
  Three Months Ended September 30,  Nine Months Ended September 30, 
  2024  2023  2024  2023 
Revenues $25,488  $32,042  $77,885  $86,302 
Operating expenses:            
Cost of revenues  958   1,184   2,707   3,386 
Selling and marketing  13,699   13,928   40,655   44,695 
Research and development  2,775   3,009   8,312   9,212 
General and administrative  3,823   1,157   10,645   4,607 
Total operating expenses  21,255   19,278   62,319   61,900 
Income from operations  4,233   12,764   15,566   24,402 
Other income (expense), net:            
Interest income, net  523   283   1,201   718 
Other expense, net  (598)  (1,333)  (1,226)  (1,281)
Change in fair value of warrant liability  (228)     6,973    
Loss on disposal of assets, net     (526)  (68)  (526)
Income before income taxes  3,930   11,188   22,446   23,313 
Provision for income taxes  (1,074)  (3,678)  (5,117)  (7,816)
Net income  2,856   7,510   17,329   15,497 
Net income attributable to noncontrolling interest  1,732   3,534   5,145   7,424 
Net income attributable to common stockholders $1,124  $3,976  $12,184  $8,073 
Net income per share attributable to common stockholders:            
Basic $0.01  $0.06  $0.14  $0.13 
Diluted $0.01  $0.05  $0.05  $0.10 
Weighted average shares used in calculating net income per share attributable to common stockholders:            
Basic  85,643,646   63,588,119   84,807,041   63,588,119 
Diluted  102,640,373   78,904,324   102,505,585   78,907,695 



Gyre Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
 
  September 30, 2024  December 31, 2023 
  (Unaudited)    
Assets      
Current assets:      
Cash and cash equivalents $15,866  $33,509 
Short-term bank deposits  9,226    
Accounts and note receivables, net  19,487   15,552 
Other receivables from GNI  1,287   1,287 
Inventories, net  6,379   4,281 
Prepaid assets  1,051   1,547 
Other current assets  1,513   1,045 
Total current assets  54,809   57,221 
Property and equipment, net  24,442   23,288 
Long-term receivable from GCBP  4,900   4,722 
Intangible assets, net  184   205 
Right-of-use assets  1,984   489 
Land use rights, net  1,479   1,493 
Deferred tax assets  5,161   4,695 
Long-term certificates of deposit  29,515   23,431 
Other assets, noncurrent  2,766   995 
Total assets $125,240  $116,539 
Liabilities, convertible preferred stock, and equity      
Current liabilities:      
Accounts payable $303  $355 
Deferred revenue  36   39 
Due to related parties  1,288   1,369 
CVR excess closing cash payable     1,085 
Accrued expenses and other current liabilities  9,553   11,935 
Income tax payable  2,842   5,054 
Operating lease liabilities, current  694   210 
Total current liabilities  14,716   20,047 
Operating lease liabilities, noncurrent  1,101   199 
Deferred government grants  185   213 
CVR derivative liability, noncurrent  4,900   4,722 
Warrant liability, noncurrent  5,862   12,835 
Other noncurrent liabilities  2   49 
Total liabilities  26,766   38,065 
Convertible Preferred Stock, $0.001 par value, 5,000,000 shares authorized; nil shares and 13,151 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively     64,525 
Stockholders’ equity:      
Common stock, $0.001 par value, 400,000,000 shares authorized; 85,769,526 shares and 76,595,616 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively  85   77 
Additional paid-in capital  134,296   68,179 
Statutory reserve  3,098   3,098 
Accumulated deficit  (73,354)  (85,538)
Accumulated other comprehensive loss  (946)  (1,644)
Total Gyre stockholders’ equity (deficit)  63,179   (15,828)
Noncontrolling interest  35,295   29,777 
Total equity  98,474   13,949 
Total liabilities, convertible preferred stock, and equity $125,240  $116,539 



Gyre Therapeutics, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(In thousands)
(Unaudited)
 
 Three Months Ended September 30,  Nine Months Ended September 30, 
 2024  2023  2024  2023 
Net income$2,856  $7,510  $17,329  $15,497 
Loss (gain) from change in fair value of warrants (1) 228      (6,973)   
Stock-based compensation 237      264    
Provision for income taxes 1,074   3,678   5,117   7,816 
Non-GAAP adjusted net income$4,395  $11,188  $15,737  $23,313 
 
(1) Reflects adjustments for fair value of warrants based on the Black-Scholes option pricing model.



FAQ

What were Gyre Therapeutics (GYRE) Q3 2024 revenue and earnings?

Gyre Therapeutics reported Q3 2024 revenue of $25.5 million and net income of $2.9 million.

When will Gyre Therapeutics (GYRE) release F351 Phase 3 trial results?

Gyre Therapeutics expects to release topline data from the F351 Phase 3 trial in CHB-associated liver fibrosis in Q1 2025.

What is Gyre Therapeutics' (GYRE) cash position as of Q3 2024?

Gyre Therapeutics had cash and cash equivalents of $15.9 million as of September 30, 2024.

When will Gyre Therapeutics (GYRE) launch avatrombopag in China?

Gyre Therapeutics plans to launch avatrombopag in China in the first half of 2025.

Gyre Therapeutics, Inc.

NASDAQ:GYRE

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1.26B
93.42M
74.7%
1.38%
0.48%
Biotechnology
Pharmaceutical Preparations
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United States of America
SAN DIEGO