FibroGen Reports Fourth Quarter and Full Year 2019 Financial Results
- Roxadustat NDA submission accepted with PDUFA date of
December 20, 2020 - Pamrevlumab pivotal trials for treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC) underway
Enrique Conterno appointed Chief Executive Officer
“I am thrilled to be joining
"
Key Events in Recent Months and Other Developments
Roxadustat
U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in non-dialysis-dependent and dialysis-dependent patients, accepted with a Prescription Drug User Fee Act (PDUFA) date ofDecember 20, 2020 .- Received expanded approval of roxadustat (
China tradename: 爱瑞卓®) inChina for the treatment of anemia in CKD patients who are not dialysis-dependent. - Achieved roxadustat inclusion in the China National Reimbursement Drug List.
- In
Japan , partner Astellas received approval of and launched roxadustat (Japan trade name Evrenzo®) in anemia in dialysis-dependent CKD patients, and submitted the supplemental NDA for the non-dialysis indication this past January. - Results from the open-label portion of our Phase 3 study of roxadustat for treatment of anemia in patients with myelodysplastic syndromes (MDS) presented at the 2019
American Society of Hematology Annual Meeting. The randomized placebo-controlled, double-blind portion of this global Phase 3 study is ongoing. - Initiated Phase 2 open-label study of roxadustat for chemotherapy-induced anemia (CIA).
Pamrevlumab
- Initiated the ZEPHYRUS Phase 3 clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
- In 2020, we will initiate ZEPHYRUS 2, a second IPF Phase 3 study similar in design to ZEPHYRUS.
- We plan to enroll approximately 340 patients in each study.
- Initiated the LAPIS Phase 3 clinical trial of pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer (LAPC).
Upcoming Events
- In
Europe , partner Astellas expects to submit Marketing Authorization Application (MAA) for roxadustat for treatment of dialysis- and non-dialysis-dependent CKD anemia in the second quarter of 2020. - Plan to initiate a pamrevlumab Phase 3 study in DMD in the second half 2020.
Corporate and Financial
- Net loss for the fourth quarter of 2019 was
$98.1 million , or$1.12 net loss per basic and diluted share, compared to a net income of$21.0 million , or$0.25 net income per basic share and$0.23 net income per diluted share one year ago. - Net loss for the year was
$77.0 million , or$0.89 net loss per basic and diluted share, compared to a net loss of$86.4 million , or$1.03 net loss per basic and diluted share one year ago. - At
December 31, 2019 ,FibroGen had$627.1 million in cash, restricted time deposits, cash equivalents, investments, and receivables. - Based on our latest forecast, we estimate our 2020 ending cash to be in the range of
$720 million to$730 million .
Conference Call and Webcast Details
About Roxadustat
Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin synthesis and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of chronic kidney disease (CKD) patients, including in the presence of inflammation and without a need for supplemental intravenous iron. Roxadustat is currently approved in
Astellas and
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by
About
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, our financial results, 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)
| December 31, 2019 | December 31, 2018 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 126,266 | $ | 89,258 | ||||
| Short-term investments | 407,491 | 532,144 | ||||||
| Accounts receivable, net | 28,455 | 63,684 | ||||||
| Inventory | 6,887 | — | ||||||
| Prepaid expenses and other current assets | 133,391 | 4,929 | ||||||
| Total current assets | 702,490 | 690,015 | ||||||
| Restricted time deposits | 2,072 | 4,145 | ||||||
| Long-term investments | 61,118 | 55,820 | ||||||
| Property and equipment, net | 42,743 | 127,198 | ||||||
| Finance lease right-of-use assets | 39,602 | — | ||||||
| Other assets | 9,372 | 3,420 | ||||||
| Total assets | $ | 857,397 | $ | 880,598 | ||||
| Liabilities, stockholders’ equity and non-controlling interests | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,088 | $ | 9,139 | ||||
| Accrued and other liabilities | 83,816 | 66,123 | ||||||
| Deferred revenue | 490 | 13,771 | ||||||
| Finance lease liabilities, current | 12,351 | — | ||||||
| Total current liabilities | 102,745 | 89,033 | ||||||
| Long-term portion of lease obligations | 1,141 | 97,157 | ||||||
| Product development obligations | 16,780 | 16,798 | ||||||
| Deferred rent | — | 3,038 | ||||||
| Deferred revenue, net of current | 99,449 | 136,109 | ||||||
| Finance lease liabilities, non-current | 37,610 | — | ||||||
| Other long-term liabilities | 64,266 | 9,993 | ||||||
| Total liabilities | 321,991 | 352,128 | ||||||
| Total stockholders’ equity | 516,135 | 509,199 | ||||||
| Non-controlling interests | 19,271 | 19,271 | ||||||
| Total equity | 535,406 | 528,470 | ||||||
| Total liabilities, stockholders’ equity and non-controlling interests | $ | 857,397 | $ | 880,598 | ||||
(1) The condensed consolidated balance sheet amounts at
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
| Three Months Ended December 31, | Years Ended December 31, |
||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| (Unaudited) | (Unaudited) | (1) | |||||||||||||
| Revenue: | |||||||||||||||
| License revenue | $ | 14,569 | $ | 7,947 | $ | 177,086 | $ | 22,269 | |||||||
| Development and other revenue | 28,607 | 35,331 | 114,115 | 125,913 | |||||||||||
| Product revenue, net | (35,202 | ) | 64,776 | (34,624 | ) | 64,776 | |||||||||
| Total revenue | 7,974 | 108,054 | 256,577 | 212,958 | |||||||||||
| Operating costs and expenses: | |||||||||||||||
| Cost of goods sold | 905 | — | 1,147 | — | |||||||||||
| Research and development | 56,797 | 70,284 | 209,265 | 235,839 | |||||||||||
| Selling, general and administrative | 50,708 | 17,851 | 135,479 | 63,812 | |||||||||||
| Total operating costs and expenses | 108,410 | 88,135 | 345,891 | 299,651 | |||||||||||
| Income (loss) from operations | (100,436 | ) | 19,919 | (89,314 | ) | (86,693 | ) | ||||||||
| Interest and other, net: | |||||||||||||||
| Interest expense | (668 | ) | (2,734 | ) | (2,876 | ) | (10,991 | ) | |||||||
| Interest income and other, net | 3,053 | 3,772 | 15,548 | 11,568 | |||||||||||
| Total interest and other, net | 2,385 | 1,038 | 12,672 | 577 | |||||||||||
| Income (loss) before income taxes | (98,051 | ) | 20,957 | (76,642 | ) | (86,116 | ) | ||||||||
| Provision for income taxes | 72 | 5 | 328 | 304 | |||||||||||
| Net income (loss) | $ | (98,123 | ) | $ | 20,952 | $ | (76,970 | ) | $ | (86,420 | ) | ||||
| Net income (loss) per share | |||||||||||||||
| Basic | $ | (1.12 | ) | $ | 0.25 | $ | (0.89 | ) | $ | (1.03 | ) | ||||
| Diluted | $ | (1.12 | ) | $ | 0.23 | $ | (0.89 | ) | $ | (1.03 | ) | ||||
| Weighted average number of common shares used to calculate net income (loss) per share: | |||||||||||||||
| Basic | 87,352 | 85,096 | 86,633 | 84,062 | |||||||||||
| Diluted | 87,352 | 91,260 | 86,633 | 84,062 | |||||||||||
(1) The condensed consolidated statement of operations amounts for the year ended
Contact:
Media Inquiries:
1.703.474.4452
sara.iacovino@gcihealth.com
Investors:
Investor Relations
1.415.978.1433
ir@fibrogen.com
Source: FibroGen, Inc