• FibroGen Reports Fourth Quarter and Full Year 2020 Financial Results

    Источник: Nasdaq GlobeNewswire / 01 мар 2021 16:01:00   America/New_York

    • Strong Fourth Quarter China Roxadustat Net Sales of $29.2 Million and 2020 full-year Net Sales of $72.5 Million

    • FDA to hold Advisory Committee Meeting on Roxadustat New Drug Application

    SAN FRANCISCO, March 01, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2020 and provided an update on the company’s recent developments.

    “While disappointed with the news today, FibroGen and AstraZeneca remain confident in the efficacy and safety profile of roxadustat based on positive results from a global Phase 3 program encompassing more than 8,000 patients,” said Enrique Conterno, Chief Executive Officer, FibroGen. “With strong roxadustat commercial results in China, we continue to drive forward in our three main areas of focus: ensuring the regulatory and commercial success of roxadustat; accelerating the development of pamrevlumab in the three high-value indications of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF); and building our research capabilities in both hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology while adding to our clinical development pipeline.”

    Key Events in 2020 and Other Developments

    Roxadustat

    • Regulatory:
      • The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will hold an advisory committee (AdCom) meeting to review the new drug application (NDA) for roxadustat in the U.S. The companies have not received a confirmed AdCom meeting date from the FDA.
      • In November 2020, Japan's Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO® (roxadustat) for the treatment of anemia of CKD in adult patients not on dialysis.
      • The Marketing Authorization Application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD was accepted for regulatory review by the European Medicines Agency (EMA) in May 2020, with an expected decision by mid-2021.
    • Clinical:
      • Enrollment was completed in the WHITNEY US Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA) in 4Q 2020.
      • Enrollment continued in the MATTERHORN Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS).
      • Enrollment was completed in the ASPEN and DENALI Phase 3b roxadustat clinical trials in dialysis patients with anemia of CKD.
    • Publications / Presentations:
      • Roxadustat data was presented at the following scientific meetings in 2020:
        • The National Kidney Foundation Spring Clinical Meeting
        • The 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress
        • The American Society of Nephrology (ASN) Kidney Week 2020 Reimagined
        • The 62nd American Society of Hematology (ASH) Annual Meeting and Exposition
      • Roxadustat Phase 3 manuscripts on the treatment of anemia of CKD were published in peer-reviewed medical journals:

    Pamrevlumab

    • Enrollment continued in the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
    • Enrollment continued in the LELANTOS Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy (DMD). 
    • Enrollment continued in the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
    • In December, we initiated a second Phase 3 clinical trial of pamrevlumab, ZEPHYRUS-2, in patients with idiopathic pulmonary fibrosis (IPF).

    Upcoming Data Catalysts

    • Data from the Phase 2 WHITNEY study of roxadustat in chemotherapy-induced anemia (CIA) expected 2H 2021.
    • Data from the Phase 3 MATTERHORN study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2022.
    • Resection data from the Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) expected 2H 2022.
    • Data from the Phase 3 LELANTOS study of pamrevlumab in Duchenne muscular dystrophy (DMD) expected 2H 2022.

    2020 Key Executive Additions

    • Percy Carter, Ph.D., was appointed to the newly created position of Chief Scientific Officer.
    • Mark Eisner, M.D., M.P.H., was appointed as Chief Medical Officer.
    • Thane Wettig was appointed to the newly created position of Chief Commercial Officer.

    Financial

    • Total revenue for the fourth quarter of 2020 was $65.0 million, as compared to $8.0 million for the fourth quarter of 2019. The current quarter revenue consists of net product revenues of $29.2 million for roxadustat sales in China, $21.5 million in development revenue, and $14.3 million in license revenue related to NDD approval in Japan. Total net roxadustat sales in China for 2020 were $72.5 million.
    • Net loss for the fourth quarter of 2020 was $58.6 million, or $0.64 net loss per basic and diluted share, compared to a net loss of $98.1 million, or $1.12 net loss per basic and diluted share one year ago.
    • Net loss for the year was $189.3 million, or $2.11 net loss per basic and diluted share, compared to a net loss of $77.0 million, or $0.89 net loss per basic and diluted share one year ago.
    • At December 31, 2020, FibroGen had $732.1 million in cash, restricted time deposits, cash equivalents, investments, and receivables.
    • Based on our latest forecast, we estimate our 2021 ending cash to be in the range of $660 to $670 million.
    • The China Agreement with AstraZeneca was amended in July 2020 to maximize the economic value of the roxadustat franchise for both parties with more predictable economics and profitability for FibroGen.

    Conference Call and Webcast Details
    FibroGen will host a conference call and webcast today, Monday, March 1, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen fourth quarter and full year 2020 financial results conference call, and use confirmation number 3055327. A replay of the webcast will be available shortly after the call for a period of four weeks. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 3055327.

    About Roxadustat
    Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

    Roxadustat is approved in China, Japan, and Chile for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia in with chronic kidney disease (CKD) in NDD and DD patients was filed by Astellas Pharma Inc. (Astellas) and accepted by the European Medicines Agency for review in May 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

    About Pamrevlumab
    Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Condensed Consolidated Balance Sheets
    (In thousands)

     December 31,
    2020    		  December 31,
    2019    		 
     (Unaudited)  (1) 
    Assets       
    Current assets:       
    Cash and cash equivalents$678,393  $126,266 
    Short-term investments 8,144   407,491 
    Accounts receivable, net 41,883   28,455 
    Inventory 16,530   6,887 
    Prepaid expenses and other current assets 10,160   133,391 
    Total current assets 755,110   702,490 
            
    Restricted time deposits 2,072   2,072 
    Long-term investments 244   61,118 
    Property and equipment, net 33,647   42,743 
    Finance lease right-of-use assets 29,606   39,602 
    Equity method investment in unconsolidated variable interest entity 2,728   — 
    Other assets 3,433   9,372 
    Total assets$826,840  $857,397 
            
    Liabilities, stockholders’ equity and non-controlling interests       
    Current liabilities:       
    Accounts payable$24,789  $6,088 
    Accrued and other liabilities 119,521   83,816 
    Deferred revenue 6,547   490 
    Finance lease liabilities, current 12,330   12,351 
    Total current liabilities 163,187   102,745 
            
    Product development obligations 18,697   16,780 
    Deferred revenue, net of current 138,474   99,449 
    Finance lease liabilities, non-current 25,391   37,610 
    Other long-term liabilities 39,642   65,407 
    Total liabilities 385,391   321,991 
            
    Total stockholders’ equity 422,178   516,135 
    Non-controlling interests 19,271   19,271 
    Total equity 441,449   535,406 
    Total liabilities, stockholders’ equity and non-controlling interests$826,840  $857,397 
            

    (1)   The condensed consolidated balance sheet amounts at December 31, 2019 are derived from audited financial statements.

    Condensed Consolidated Statements of Operations
    (In thousands, except per share data)

     Three Months Ended
    December 31,    		  Years Ended
    December 31,    		 
     2020  2019  2020  2019 
             
     (Unaudited)  (Unaudited)  (1) 
    Revenue:               
    License revenue$14,323  $14,569  $14,323  $177,086 
    Development and other revenue 21,527   28,607   80,592   114,115 
    Product revenue, net 29,165   1,122   72,498   1,700 
    Drug product revenue (17)  (36,324)  8,906   (36,324)
    Total revenue 64,998   7,974   176,319   256,577 
    Operating costs and expenses:               
    Cost of goods sold 2,615   905   8,869   1,147 
    Research and development 78,133   56,797   252,924   209,265 
    Selling, general and administrative 42,249   50,708   106,406   135,479 
    Total operating costs and expenses 122,997   108,410   368,199   345,891 
    Loss from operations (57,999)  (100,436)  (191,880)  (89,314)
    Interest and other, net:               
    Interest expense (538)  (668)  (2,402)  (2,876)
    Investment loss in unconsolidated variable
    interest entity    		 (190)  —   (202)  — 
    Interest income and other, net 264   3,053   5,553   15,548 
    Total interest and other, net (464)  2,385   2,949   12,672 
    Loss before income taxes (58,463)  (98,051)  (188,931)  (76,642)
    Provision for income taxes 171   72   360   328 
    Net loss$(58,634) $(98,123) $(189,291) $(76,970)
                    
    Net loss per share - basic and diluted$(0.64) $(1.12) $(2.11) $(0.89)
                    
    Weighted average number of common shares used to calculate net loss per share - basic and diluted 91,166   87,352   89,854   86,633 
                    

    (1)   The condensed consolidated statement of operations amounts for the year ended December 31, 2019 are derived from audited financial statements.

    Contacts:
    FibroGen, Inc.

    Investors:
    Michael Tung, M.D.
    Corporate Strategy / Investor Relations
    415.978.1434
    mtung@fibrogen.com 

    Media:
    Jennifer Harrington
    610.574.9196
    Jennifer.Harrington@gcihealth.com 


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