FibroGen Reports First Quarter 2022 Financial Results
- Completed enrollment in ZEPHYRUS-1 Phase 3 study of pamrevlumab in idiopathic pulmonary fibrosis
- 1Q 2022 revenue of
$60.8M , growth of 58% vs. 1Q 2021 - Significant roxadustat volume growth in
China in first quarter 2022 offsetting NRDL price reduction
“We continue our progress in advancing pamrevlumab in three high value indications and are delighted to have completed enrollment of the ZEPHYRUS-1 Phase 3 study in idiopathic pulmonary fibrosis,” said
Recent Developments:
- Completed enrollment of the ZEPHYRUS-1 Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
- Completed enrollment of the LELANTOS-1 Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy (DMD).
- Our partner Astellas received approval for roxadustat in
Russia for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD), which triggered a$25 million milestone payable to FibroGen (FGEN).
China Performance:
- FibroGen’s net product revenue under U.S. GAAP from sale of roxadustat in
China was$18.9 million compared to$15.4 million in the first quarter of 2021. Increase driven mainly due to release of deferred revenue. - First quarter total roxadustat net sales in
China 1 by FibroGen (FGEN) and the distribution entity (JDE) jointly owned by FibroGen (FGEN) and AstraZeneca was$43.5 million , flat as compared to the first quarter of 2021. This result was driven by an increase in volume of over 70% offset by the recent National Reimbursement Drug List (NRDL) price reduction. - Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in
China .
Upcoming Milestones:
- Interim analysis of event free survival of the LAPIS Phase 3 study of pamrevlumab in locally advanced pancreatic cancer (LAPC) to be conducted in 2Q 2022.
- Topline data from the LELANTOS-1 Phase 3 study of pamrevlumab in DMD expected 1H 2023.
- Expect to complete enrollment in the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory patients with DMD in 2Q 2022.
- Topline data from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in IPF expected mid-2023.
- Topline data from the MATTERHORN Phase 3 study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2023.
Financial:
- Total revenue for the first quarter of 2022 was
$60.8 million , as compared to$38.4 million for the first quarter of 2021. - Net loss for the first quarter of 2022 was
$63.2 million , or$0.68 net loss per basic and diluted share, compared to a net loss of$71.8 million , or$0.78 net loss per basic and diluted share one year ago. - At
March 31, 2022 , FibroGen (FGEN) had$565.4 million in cash - defined as cash, cash equivalents, investments, and accounts receivable. - Based on our latest forecast, we estimate a 2022 ending cash balance of
$310-340 million .
________________
1 Total roxadustat net sales in
Conference Call and Webcast Details
FibroGen (FGEN) will host a conference call and webcast today,
About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen (FGEN) 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). 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.
About Roxadustat
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 European Union (EU) member states, including the European Economic Area (EEA) countries, as well as in
Astellas and FibroGen (FGEN) are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including
About FibroGen (FGEN)
FibroGen, Inc. (FGEN) is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of potential 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), and Duchenne muscular dystrophy (DMD). 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). FibroGen (FGEN) 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
Condensed Consolidated Balance Sheets (In thousands) | |||||
(Unaudited) | (1) | ||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 185,896 | $ | 171,223 | |
Short-term investments | 242,179 | 233,967 | |||
Accounts receivable, net | 43,883 | 17,401 | |||
Inventory | 43,067 | 31,015 | |||
Prepaid expenses and other current assets | 9,390 | 20,453 | |||
Total current assets | 524,415 | 474,059 | |||
Restricted time deposits | 2,072 | 2,072 | |||
Long-term investments | 93,488 | 167,796 | |||
Property and equipment, net | 26,881 | 28,277 | |||
Equity method investment in unconsolidated variable interest entity | 4,155 | 3,825 | |||
Operating lease right-of-use assets | 87,990 | 91,112 | |||
Other assets | 6,933 | 6,680 | |||
Total assets | $ | 745,934 | $ | 773,821 | |
Liabilities, stockholders’ equity and non-controlling interests | |||||
Current liabilities: | |||||
Accounts payable | $ | 36,353 | $ | 26,097 | |
Accrued and other liabilities | 203,299 | 172,599 | |||
Deferred revenue | 4,744 | 15,857 | |||
Operating lease liabilities, current | 10,978 | 10,944 | |||
Total current liabilities | 255,374 | 225,497 | |||
Product development obligations | 17,374 | 17,613 | |||
Deferred revenue, net of current | 184,893 | 186,801 | |||
Operating lease liabilities, non-current | 85,948 | 88,776 | |||
Other long-term liabilities | 24,330 | 26,021 | |||
Total liabilities | 567,919 | 544,708 | |||
Total stockholders’ equity | 158,048 | 209,146 | |||
Non-controlling interests | 19,967 | 19,967 | |||
Total equity | 178,015 | 229,113 | |||
Total liabilities, stockholders’ equity and non-controlling interests | $ | 745,934 | $ | 773,821 |
(1) The condensed consolidated balance sheet amounts at
Condensed Consolidated Statements of Operations (In thousands, except per share data) | |||||||
Three Months Ended | |||||||
2022 | 2021 | ||||||
(Unaudited) | |||||||
Revenue: | |||||||
License revenue | $ | 22,590 | $ | — | |||
Development and other revenue | 11,762 | 14,587 | |||||
Product revenue, net | 18,881 | 15,362 | |||||
Drug product revenue | 7,594 | 8,480 | |||||
Total revenue | 60,827 | 38,429 | |||||
Operating costs and expenses: | |||||||
Cost of goods sold | 4,238 | 3,401 | |||||
Research and development | 89,018 | 74,676 | |||||
Selling, general and administrative | 30,564 | 30,779 | |||||
Total operating costs and expenses | 123,820 | 108,856 | |||||
Loss from operations | (62,993 | ) | (70,427 | ) | |||
Interest and other, net: | |||||||
Interest expense | (97 | ) | (501 | ) | |||
Interest income and other income (expenses), net | (322 | ) | (453 | ) | |||
Total interest and other, net | (419 | ) | (954 | ) | |||
Loss before income taxes | (63,412 | ) | (71,381 | ) | |||
Provision for income taxes | 113 | 134 | |||||
Investment income (loss) in unconsolidated variable interest entity | 320 | (240 | ) | ||||
Net loss | $ | (63,205 | ) | $ | (71,755 | ) | |
Net loss per share - basic and diluted | $ | (0.68 | ) | $ | (0.78 | ) | |
Weighted average number of common shares used to calculate net loss per share - basic and diluted | 93,043 | 91,688 | |||||
Contacts:
FibroGen, Inc. (FGEN)
Investors:
Corporate Strategy / Investor Relations
415.978.1434
mtung@fibrogen.com
Media:
Meichiel Keenan
Investor Relations and Corporate Communications
mkeenan@fibrogen.com
Image: https://ml.globenewswire.com/media/YjQyOTVkZmEtNDYzNC00NDY4LWE5ZjUtYmY5MzI4YzFmN2NiLTEwMTk1MzY=/tiny/FibroGen-Inc-.png
Image: Primary Logo
Source: FibroGen, Inc. (FGEN)