FibroGen Reports Third Quarter 2022 Financial Results

07 Nov 2022
www.globenewswire.com
Financial StatementAntibodyOrphan DrugFirst in ClassFast Track
FibroGen Reports Third Quarter 2022 Financial Results
Continued advancement of pamrevlumab clinical trials – topline data from five pivotal Phase 3 trials beginning in 1H 2023 through mid-2024
Completed enrollment of MATTERHORN Phase 3 study of roxadustat in patients with anemia of myelodysplastic syndromes with topline data expected 1H 2023
Strong roxadustat volume growth in China of over 80% vs 3Q 2021
Announced non-dilutive royalty monetization transaction with NovaQuest for $50 million of capital secured by 22.5% of roxadustat royalty revenue in the Astellas territories
SAN FRANCISCO, Nov. 07, 2022 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2022 and provided an update on the company’s recent developments.
“I am very pleased with our progress across our clinical development programs with 3 pivotal trials expected to read out for pamrevlumab in 2023 and two more in 2024. Notably, our Phase 3 trials of roxadustat in the U.S. and Europe for anemia of myelodysplastic syndromes, and chemotherapy-induced anemia in China add two more pivotal readouts next year,” said Enrique Conterno, Chief Executive Officer, FibroGen. “The strategic financing transaction with NovaQuest provides additional non-dilutive capital which strengthens our balance sheet to support the development and commercialization of pamrevlumab while continuing to advance and expand our pipeline.”
Recent Developments:
Announced non-dilutive royalty monetization transaction with NovaQuest Capital Management secured by 22.5% of roxadustat royalty revenue in the territories licensed to Astellas Pharma Inc., providing $50 million to support our strategic priorities.
Completed enrollment of the MATTERHORN Phase 3 study of roxadustat in patients with anemia of myelodysplastic syndromes (MDS).
Roxadustat continues to gain approvals in additional countries around the world. It is now approved in China, Europe, Japan, and numerous other territories for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis.
China Performance:
FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $17.4 million compared to $13.4 million in the third quarter of 2021, an increase of 29%.
Third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen, and AstraZeneca was $59.0 million, compared to $57.8 million in the third quarter of 2021.
Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.
Topline data from the LELANTOS-1 Phase 3 study of pamrevlumab in non-ambulatory DMD patients expected 1H 2023.
Topline data from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in IPF expected mid-2023.
Topline data from the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory DMD patients expected 2H 2023.
Topline data from the LAPIS Phase 3 study of pamrevlumab in LAPC expected 1H 2024.
Topline data from the ZEPHYRUS-2 Phase 3 study of pamrevlumab in IPF expected mid-2024.
Topline data from the MATTERHORN Phase 3 study of roxadustat in anemia of MDS expected 1H 2023.
Topline data from the China Phase 3 study of roxadustat for the treatment of chemotherapy-induced anemia (CIA) expected mid-2023.
Financial:
Total revenue for the third quarter of 2022 was $15.7 million, as compared to $156.0 million for the third quarter of 2021, which included $120 million of milestone payments from Astellas related to the EU approval of roxadustat.
Net loss for the third quarter of 2022 was $91.7 million, or $0.98 net loss per basic and diluted share, compared to a net income of $49.8 million, or $0.54 net income per basic and diluted share one year ago.
At September 30, 2022, FibroGen had $441.6 million in cash - defined as cash, cash equivalents, investments, and accounts receivable.
Today we announced a non-dilutive royalty monetization transaction with NovaQuest Capital Management, providing $50 million to support our strategic priorities.
After this transaction and based on our latest forecast, we anticipate our 2022 ending cash balance to be $380-$410 million.
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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.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, November 7, 2022, 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 access the call by phone, please go to this link (registration link), and you will be provided with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. 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), and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD), and Fast Track designation to pamrevlumab for the treatment of patients with IPF, DMD, and LAPC. The U.S. Food and Drug Administration has also granted Rare Pediatric Disease Designation to pamrevlumab for the treatment of patients with DMD. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in IPF, DMD, and LAPC. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
Roxadustat, 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 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 China, Europe, Japan, and numerous other countries 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, and other markets not licensed to Astellas.
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 connective tissue growth factor (CTGF) biology and hypoxia-inducible factor (HIF) to advance innovative medicines for the treatment of unmet needs. 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), metastatic pancreatic cancer, and Duchenne muscular dystrophy (DMD). Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes (MDS), and in Phase 3 clinical development in China for the treatment of chemotherapy-induced anemia (CIA). 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, and our clinical programs. 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, 2021 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, each as 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, 2022 December 31, 2021 (Unaudited) (1)Assets Current assets: Cash and cash equivalents$155,960 $171,223 Short-term investments 252,560 233,967 Accounts receivable, net 15,328 17,401 Inventory 39,950 31,015 Prepaid expenses and other current assets 10,426 20,453 Total current assets 474,224 474,059 Restricted time deposits 2,072 2,072 Long-term investments 17,780 167,796 Property and equipment, net 22,287 28,277 Equity method investment in unconsolidated variable interest entity 4,631 3,825 Operating lease right-of-use assets 82,903 91,112 Other assets 4,940 6,680 Total assets$608,837 $773,821 Liabilities, stockholders’ equity and non-controlling interests Current liabilities: Accounts payable$19,323 $26,097 Accrued and other liabilities 213,806 172,599 Deferred revenue 7,361 15,857 Operating lease liabilities, current 11,504 10,944 Total current liabilities 251,994 225,497 Product development obligations 15,422 17,613 Deferred revenue, net of current 199,758 186,801 Operating lease liabilities, non-current 81,091 88,776 Other long-term liabilities 14,299 26,021 Total liabilities 562,564 544,708 Total stockholders’ equity 26,306 209,146 Non-controlling interests 19,967 19,967 Total equity 46,273 229,113 Total liabilities, stockholders’ equity and non-controlling interests$608,837 $773,821
(1) The condensed consolidated balance sheet amounts at December 31, 2021 are derived from audited financial statements.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
Three Months Ended
September 30, Nine Months Ended
September 30, 2022 2021 2022 2021 (Unaudited) Revenue: License revenue$— $116,434 $22,590 $116,434 Development and other revenue 2,453 26,097 19,672 60,325 Product revenue, net 17,359 13,442 59,495 42,175 Drug product revenue (4,077) — 4,610 (168)Total revenue 15,735 155,973 106,367 218,766 Operating costs and expenses: Cost of goods sold 4,308 3,266 15,355 9,746 Research and development 75,182 75,880 235,163 273,123 Selling, general and administrative 29,902 25,853 90,722 89,186 Total operating costs and expenses 109,392 104,999 341,240 372,055 Income (loss) from operations (93,657) 50,974 (234,873) (153,289) Interest and other, net: Interest expense (84) (109) (321) (965)Interest income and other income (expenses), net 1,798 (1,303) 6,672 (2,120)Total interest and other, net 1,714 (1,412) 6,351 (3,085) Income (loss) before income taxes (91,943) 49,562 (228,522) (156,374)Provision for income taxes 114 106 250 235 Investment income in unconsolidated variable interest entity 407 342 1,293 664 Net income (loss)$(91,650) $49,798 $(227,479) $(155,945) Net income (loss) per share - basic and diluted$(0.98) $0.54 $(2.43) $(1.69) Weighted average number of common shares used to calculate net income (loss) per share: Basic 93,767 92,644 93,431 92,206 Diluted 93,767 92,808 93,431 92,206 Contacts:
Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
415.978.1434
mtung@fibrogen.com
Media:
Meichiel Keenan
Investor Relations and Corporate Communications
mkeenan@fibrogen.com


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