FibroGen, Inc. (NASDAQ:FGEN) reported financial results for the second quarter of 2020 and provided an update on the company’s recent developments.

“Despite this difficult time, we continue to be inspired by our unique opportunity to leverage world-class science to benefit patients,” said Enrique Conterno, Chief Executive Officer, FibroGen. “I am pleased with the progress we are making with roxadustat across a number of fronts; including our engagement with the FDA, the European submission, and our impressive sales in China. Additionally, we recently initiated three new trials with pamrevlumab: our Phase 3 study with DMD and two trials in patients hospitalized with COVID-19.”

Key Events in Recent Months and Other Developments

Roxadustat

  • U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in dialysis-dependent and non-dialysis-dependent patients, is under review with a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020.
  • Marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis, accepted by the European Medicines Agency (EMA) for regulatory review in May.
  • Japan sNDA for roxadustat for the treatment of anemia of CKD in non-dialysis-dependent patients is under review.
  • Presented results from the DOLOMITES Phase 3 study at the 57th ERA-EDTA Virtual Congress in which roxadustat demonstrated non-inferiority to darbepoetin alfa in achievement of hemoglobin correction in non-dialysis-dependent patients with CKD.
  • Continued enrollment of Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS) and Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA).

Pamrevlumab

  • Initiated a randomized, double-blind, placebo-controlled Phase 2 study investigating the efficacy and safety of pamrevlumab in approximately 130 hospitalized patients with acute COVID-19 infection in the U.S.
  • Initiated BOREA, a Phase 2/3 investigator-initiated clinical trial investigating the efficacy and safety of pamrevlumab in approximately 68 patients hospitalized with COVID-19 in Italy.
  • Reopened enrollment of the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with IPF after pausing for two months to minimize the risk of exposure to COVID-19.
  • Continued enrollment of the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).

Upcoming Events

  • Plan to initiate ZEPHYRUS 2, a second IPF Phase 3 clinical trial similar in size and design to ZEPHYRUS, as COVID-19 conditions improve.
  • Plan to initiate LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab in approximately 90 patients with non-ambulatory Duchenne muscular dystrophy (DMD).

Corporate and Financial

  • Total revenue for the second quarter of 2020 was $42.9 million, as compared to $191.6 million for the second quarter of 2019. The current quarter revenue consisted of $15.7 million in net roxadustat sales in China, $19.0 million in development revenue, and $8.2 million in roxadustat API sales to Astellas in Japan.
  • Net loss for the second quarter of 2020 was $85.3 million, or $0.95 net loss per basic and diluted share, compared to a net income of $116.0 million, or $1.34 net income per basic share and $1.26 per diluted share one year ago.
  • At June 30, 2020, FibroGen had $716.0 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
  • Based on our latest forecast, we reiterate our year-end 2020 estimate to be in the range of $720 to $730 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
  • Amended China Agreement with AstraZeneca in July 2020 such that both parties are optimally aligned to maximize the economic value of the roxadustat franchise, with more predictable economics and profitability for FibroGen.
  • Appointed Thane Wettig to the newly-created position of Chief Commercial Officer.
  • Appointed Aoife Brennan, M.B., B.Ch., President and CEO of Synlogic, Inc. (NASDAQ:SYBX) to board of directors effective August 5, 2020.
  • Appointed Ben Cravatt, Ph.D., Professor and the Norton B. Gilula Chair of Chemical Biology in the Department of Chemistry at The Scripps Research Institute to board of directors effective August 5, 2020.

Conference Call and Webcast Details  FibroGen will host a conference call and webcast today, Thursday, August 6, 2020, 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 second quarter 2020 financial results conference call, and use passcode 8363719. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 8363719.

About Roxadustat Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, and improved iron absorption, transport and mobilization. Roxadustat is approved in China for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis. In Japan it is approved for the treatment of anemia in CKD patients on dialysis and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia in CKD is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act date of December 20, 2020. The Marketing Authorization Application for roxadustat for the treatment of anemia in CKD was filed by our partner Astellas and accepted by the European Medicines Agency for review on May 21, 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan and Europe. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets.

About Pamrevlumab Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19). 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 to treat 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 idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). 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, our financial results, 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, 2019 and our Quarterly Report on Form 10-Q for quarter ended June 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)

  June 30, 2020     December 31, 2019  
  (Unaudited)     (1)  
Assets              
Current assets:              
Cash and cash equivalents $ 429,269     $ 126,266    
Short-term investments   256,317       407,491    
Accounts receivable, net   26,519       28,455    
Inventory   8,582       6,887    
Prepaid expenses and other current assets   6,481       133,391    
Total current assets   727,168       702,490    
               
Restricted time deposits   2,072       2,072    
Long-term investments   229       61,118    
Property and equipment, net   36,984       42,743    
Finance lease right-of-use assets   34,368       39,602    
Other assets   6,862       9,372    
Total assets $ 807,683     $ 857,397    
               
Liabilities, stockholders’ equity and non-controlling interests              
Current liabilities:              
Accounts payable $ 5,015     $ 6,088    
Accrued and other liabilities   50,464       83,816    
Deferred revenue   9,813       490    
Finance lease liabilities, current   12,279       12,351    
Total current liabilities   77,571       102,745    
               
Long-term portion of lease obligations   940       1,141    
Product development obligations   16,959       16,780    
Deferred revenue, net of current   138,242       99,449    
Finance lease liabilities, non-current   31,586       37,610    
Other long-term liabilities   127,242       64,266    
Total liabilities   392,540       321,991    
               
Total stockholders’ equity   395,872       516,135    
Non-controlling interests   19,271       19,271    
Total equity   415,143       535,406    
Total liabilities, stockholders’ equity and non-controlling interests $ 807,683     $ 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 June 30,     Six Months Ended June 30,  
  2020     2019     2020     2019  
     
  (Unaudited)  
Revenue:                              
License revenue $     $ 150,581     $     $ 150,581  
Development and other revenue   18,957       40,985       38,402       64,848  
Product revenue, net   15,693             20,648        
Drug product revenue   8,238             8,238        
Total revenue   42,888       191,566       67,288       215,429  
Operating costs and expenses:                              
Cost of goods sold   3,076             4,047        
Research and development   61,414       52,008       116,315       102,505  
Selling, general and administrative   63,535       26,739       113,138       48,948  
Total operating costs and expenses   128,025       78,747       233,500       151,453  
Income (loss) from operations   (85,137 )     112,819       (166,212 )     63,976  
Interest and other, net:                              
Interest expense   (651 )     (736 )     (1,284 )     (1,507 )
Interest income and other, net   644       4,125       3,810       8,303  
Total interest and other, net   (7 )     3,389       2,526       6,796  
Income (loss) before income taxes   (85,144 )     116,208       (163,686 )     70,772  
Provision for (benefit from) income taxes   169       205       (25 )     180  
Net income (loss) $ (85,313 )   $ 116,003     $ (163,661 )   $ 70,592  
                               
Net income (loss) per share                              
Basic $ (0.95 )   $ 1.34     $ (1.84 )   $ 0.82  
Diluted $ (0.95 )   $ 1.26     $ (1.84 )   $ 0.77  
                               
Weighted average number of common shares used to calculate net income (loss) per share:                              
Basic   89,451       86,445       88,835       86,077  
Diluted   89,451       91,728       88,835       92,069  
                               

Contact: FibroGen, Inc.

Media Inquiries: Sara Iacovino 1.703.474.4452sara.iacovino@gcihealth.com

Investors: Michael Tung, M.D.Corporate Strategy / Investor Relations1.415.978.1434mtung@fibrogen.com

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