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SAN FRANCISCO, Nov. 09, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2021 and provided an update on the Company’s recent developments.
“We and our partner Astellas are excited to be making Evrenzo available to patients in Europe,” said Enrique Conterno, Chief Executive Officer, FibroGen. “In addition to continuously looking at opportunities to maximize the value of our portfolio of assets, following the complete response letter for roxadustat in the U.S., we are implementing a comprehensive plan which includes a cost reduction effort that will enable us to focus on our strategic priorities of development of pamrevlumab, roxadustat, and advancing our pipeline.”
Recent Key Events and Other Developments
Regulatory:
Clinical:
China:
Clinical Presentations / Publications:
Upcoming Data Milestones:
Corporate
Financial:
Conference Call and Webcast Details FibroGen will host a conference call and webcast today, Tuesday, November 9, 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 third quarter 2021 financial results conference call, and use confirmation number 1747879. A replay of the webcast will be available shortly after the call for a period of 7 days. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 1747879.
About RoxadustatRoxadustat, an oral medication, is the first in a new class of medicines comprising 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 of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).
Roxadustat is approved in European Union (EU) member states, including the European Economic Area (EEA) countries, as well as in Japan, China, Chile, and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under 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 PamrevlumabPamrevlumab 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 idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
About FibroGenFibroGen, 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), 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), and Duchenne muscular dystrophy (DMD). FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology and autoimmune space. 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, 2021 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)
| September 30, 2021 | December 31, 2020 | ||||
| (Unaudited) | (1) | ||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | $ | 274,527 | $ | 678,393 | |
| Short-term investments | 211,875 | 8,144 | |||
| Accounts receivable, net | 35,994 | 41,883 | |||
| Inventory | 29,315 | 16,530 | |||
| Prepaid expenses and other current assets | 21,688 | 10,160 | |||
| Total current assets | 573,399 | 755,110 | |||
| Restricted time deposits | 2,072 | 2,072 | |||
| Long-term investments | 142,636 | 244 | |||
| Property and equipment, net | 29,052 | 33,647 | |||
| Finance lease right-of-use assets | 771 | 29,606 | |||
| Equity method investment in unconsolidated variable interest entity | 3,421 | 2,728 | |||
| Operating lease right-of-use assets | 94,055 | 2,043 | |||
| Other assets | 5,107 | 1,390 | |||
| Total assets | $ | 850,513 | $ | 826,840 | |
| Liabilities, stockholders’ equity and non-controlling interests | |||||
| Current liabilities: | |||||
| Accounts payable | $ | 23,868 | $ | 24,789 | |
| Accrued and other liabilities | 151,346 | 118,333 | |||
| Deferred revenue | 23,256 | 6,547 | |||
| Finance lease liabilities, current | 15 | 12,330 | |||
| Operating lease liabilities, current | 10,831 | 1,188 | |||
| Total current liabilities | 209,316 | 163,187 | |||
| Product development obligations | 17,914 | 18,697 | |||
| Deferred revenue, net of current | 162,415 | 138,474 | |||
| Finance lease liabilities, non-current | 5 | 25,391 | |||
| Operating lease liabilities, non-current | 91,478 | 853 | |||
| Other long-term liabilities | 24,322 | 38,789 | |||
| Total liabilities | 505,450 | 385,391 | |||
| Total stockholders’ equity | 325,792 | 422,178 | |||
| Non-controlling interests | 19,271 | 19,271 | |||
| Total equity | 345,063 | 441,449 | |||
| Total liabilities, stockholders’ equity and non-controlling interests | $ | 850,513 | $ | 826,840 | |
(1) The condensed consolidated balance sheet amounts at December 31, 2020 are derived from audited financial statements.
Condensed Consolidated Statements of Operations(In thousands, except per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| (Unaudited) | |||||||||||||||
| Revenue: | |||||||||||||||
| License revenue | $ | 116,434 | $ | — | $ | 116,434 | $ | — | |||||||
| Development and other revenue | 26,097 | 20,663 | 60,325 | 59,065 | |||||||||||
| Product revenue, net | 13,442 | 22,683 | 42,175 | 43,331 | |||||||||||
| Drug product revenue | — | 686 | (168 | ) | 8,924 | ||||||||||
| Total revenue | 155,973 | 44,032 | 218,766 | 111,320 | |||||||||||
| Operating costs and expenses: | |||||||||||||||
| Cost of goods sold | 3,266 | 2,207 | 9,746 | 6,253 | |||||||||||
| Research and development | 75,880 | 58,476 | 273,123 | 174,792 | |||||||||||
| Selling, general and administrative | 25,853 | (48,981 | ) | 89,186 | 64,157 | ||||||||||
| Total operating costs and expenses | 104,999 | 11,702 | 372,055 | 245,202 | |||||||||||
| Income (loss) from operations | 50,974 | 32,330 | (153,289 | ) | (133,882 | ) | |||||||||
| Interest and other, net: | |||||||||||||||
| Interest expense | (109 | ) | (580 | ) | (965 | ) | (1,864 | ) | |||||||
| Interest income and other income (expenses), net | (1,303 | ) | 1,482 | (2,120 | ) | 5,292 | |||||||||
| Total interest and other, net | (1,412 | ) | 902 | (3,085 | ) | 3,428 | |||||||||
| Income (loss) before income taxes | 49,562 | 33,232 | (156,374 | ) | (130,454 | ) | |||||||||
| Provision for income taxes | 106 | 215 | 235 | 190 | |||||||||||
| Investment income (loss) in unconsolidated variable interest entity | 342 | (13 | ) | 664 | (13 | ) | |||||||||
| Net income (loss) | $ | 49,798 | $ | 33,004 | $ | (155,945 | ) | $ | (130,657 | ) | |||||
| Net income (loss) per share | |||||||||||||||
| Basic | $ | 0.54 | $ | 0.36 | $ | (1.69 | ) | $ | (1.46 | ) | |||||
| Diluted | $ | 0.54 | $ | 0.35 | $ | (1.69 | ) | $ | (1.46 | ) | |||||
| Weighted average number of common shares used to calculate net income (loss) per share: | |||||||||||||||
| Basic | 92,644 | 90,558 | 92,206 | 89,414 | |||||||||||
| Diluted | 92,808 | 93,678 | 92,206 | 89,414 | |||||||||||
Contacts:FibroGen, Inc.
Investors:Michael Tung, M.D.Corporate Strategy / Investor Relations415.978.1434mtung@fibrogen.com
Media:Meichiel KeenanAssociate Director, Public Affairsmkeenan@fibrogen.com
____________________1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.
