Full Press Release Details
FibroGen Reports First Quarter 2021 Financial Results
Roxadustat net product revenue in China of $15.4 million, on a US GAAP basis
Total roxadustat net sales in China of $43.5 million1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca, compared to $29.2 million last quarter
FDA to hold Advisory Committee Meeting on Roxadustat NDA - tentative date July 15, 2021
SAN FRANCISCO, May 10, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2021 and provided an update on the Company's recent developments.
"We are pleased at the continued adoption and growth of roxadustat in China," said Enrique Conterno, Chief Executive Officer, FibroGen. "We are looking forward to the roxadustat FDA advisory committee meeting and the approval decision in Europe over the next few months, as well as advancing our late stage pamrevlumab and roxadustat clinical programs, focused on areas of high unmet need."
Recent Key Events and Other Developments
Upcoming Data Catalysts
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, May 10, 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 first quarter 2021 financial results conference call, and use confirmation number 2036817. 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 2036817.
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 the U.S., the New Drug Application is under review by the U.S. Food and Drug Administration. In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia of CKD in patients both on dialysis and not on dialysis was filed by our partner Astellas and accepted by the European Medicines Agency for review on 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. 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 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
| March 31, 2021 | December 31, 2020 | ||||||
| (Unaudited) | (1) | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 433,508 | $ | 678,393 | |||
| Short-term investments | 110,724 | 8,144 | |||||
| Accounts receivable, net | 40,543 | 41,883 | |||||
| Inventory | 20,764 | 16,530 | |||||
| Prepaid expenses and other current assets | 16,155 | 10,160 | |||||
| Total current assets | 621,694 | 755,110 | |||||
| Restricted time deposits | 2,072 | 2,072 | |||||
| Long-term investments | 93,679 | 244 | |||||
| Property and equipment, net | 30,933 | 33,647 | |||||
| Finance lease right-of-use assets | 27,311 | 29,606 | |||||
| Equity method investment in unconsolidated variable interest entity | 2,483 | 2,728 | |||||
| Other assets | 9,129 | 3,433 | |||||
| Total assets | $ | 787,301 | $ | 826,840 | |||
| Liabilities, stockholders' equity and non-controlling interests | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 24,061 | $ | 24,789 | |||
| Accrued and other liabilities | 119,781 | 119,521 | |||||
| Deferred revenue | 10,725 | 6,547 | |||||
| Finance lease liabilities, current | 12,480 | 12,330 | |||||
| Total current liabilities | 167,047 | 163,187 | |||||
| Product development obligations | 17,962 | 18,697 | |||||
| Deferred revenue, net of current | 151,491 | 138,474 | |||||
| Finance lease liabilities, non-current | 22,193 | 25,391 | |||||
| Other long-term liabilities | 38,335 | 39,642 | |||||
| Total liabilities | 397,028 | 385,391 | |||||
| Total stockholders' equity | 371,002 | 422,178 | |||||
| Non-controlling interests | 19,271 | 19,271 | |||||
| Total equity | 390,273 | 441,449 | |||||
| Total liabilities, stockholders' equity and non-controlling interests | $ | 787,301 | $ | 826,840 |
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Revenue: | ||||||||
| License revenue | $ | - | $ | - | ||||
| Development and other revenue | 14,587 | 19,446 | ||||||
| Product revenue, net | 15,362 | 4,955 | ||||||
| Drug product revenue | 8,480 | - | ||||||
| Total revenue | 38,429 | 24,401 | ||||||
| Operating costs and expenses: | ||||||||
| Cost of goods sold | 3,401 | 970 | ||||||
| Research and development | 74,676 | 54,902 | ||||||
| Selling, general and administrative | 30,779 | 49,603 | ||||||
| Total operating costs and expenses | 108,856 | 105,475 | ||||||
| Loss from operations | (70,427 | ) | (81,074 | ) | ||||
| Interest and other, net: | ||||||||
| Interest expense | (501 | ) | (633 | ) | ||||
| Interest income and other income (expenses), net | (453 | ) | 3,165 | |||||
| Total interest and other, net | (954 | ) | 2,532 | |||||
| Loss before income taxes | (71,381 | ) | (78,542 | ) | ||||
| Provision for income taxes | 134 | (194 | ) | |||||
| Investment loss in unconsolidated variable interest entity | (240 | ) | - | |||||
| Net loss | $ | (71,755 | ) | $ | (78,348 | ) | ||
| Net loss per share - basic and diluted | $ | (0.78 | ) | $ | (0.89 | ) | ||
| Weighted average number of common shares used to calculate net loss per share - basic and diluted | 91,688 | 88,219 |
Corporate Strategy / Investor Relations