Full Press Release Details
FibroGen Reports Fourth Quarter and Full Year 2020 Financial Results
SAN FRANCISCO, March 1, 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
Upcoming Data Catalysts
2020 Key Executive Additions
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.
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.
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.
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
| 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 |
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 |
Corporate Strategy / Investor Relations