FibroGen Reports Second Quarter 2020 Financial Results
- Strong Second Quarter China Roxadustat Net Sales of
- Conference Call Today at
“Despite this difficult time, we continue to be inspired by our unique opportunity to leverage world-class science to benefit patients,” said Enrique Conterno, Chief Executive Officer, FibroGen. “I am pleased with the progress we are making with roxadustat across a number of fronts; including our engagement with the FDA, the European submission, and our impressive sales in
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 dialysis-dependent and non-dialysis-dependent patients, is under review with a Prescription Drug User Fee Act (PDUFA) date ofDecember 20, 2020 .- Marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis, accepted by the
European Medicines Agency (EMA) for regulatory review in May. Japan sNDA for roxadustat for the treatment of anemia of CKD in non-dialysis-dependent patients is under review.- Presented results from the DOLOMITES Phase 3 study at the 57th
ERA-EDTA Virtual Congress in which roxadustat demonstrated non-inferiority to darbepoetin alfa in achievement of hemoglobin correction in non-dialysis-dependent patients with CKD. - Continued enrollment of Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS) and Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA).
Pamrevlumab
- Initiated a randomized, double-blind, placebo-controlled Phase 2 study investigating the efficacy and safety of pamrevlumab in approximately 130 hospitalized patients with acute COVID-19 infection in the
U.S. - Initiated BOREA, a Phase 2/3 investigator-initiated clinical trial investigating the efficacy and safety of pamrevlumab in approximately 68 patients hospitalized with COVID-19 in
Italy . - Reopened enrollment of the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with IPF after pausing for two months to minimize the risk of exposure to COVID-19.
- Continued enrollment of the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
Upcoming Events
- Plan to initiate ZEPHYRUS 2, a second IPF Phase 3 clinical trial similar in size and design to ZEPHYRUS, as COVID-19 conditions improve.
- Plan to initiate LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab in approximately 90 patients with non-ambulatory Duchenne muscular dystrophy (DMD).
Corporate and Financial
- Total revenue for the second quarter of 2020 was
$42.9 million , as compared to$191.6 million for the second quarter of 2019. The current quarter revenue consisted of$15.7 million in net roxadustat sales inChina ,$19.0 million in development revenue, and$8.2 million in roxadustat API sales to Astellas inJapan . - Net loss for the second quarter of 2020 was
$85.3 million , or$0.95 net loss per basic and diluted share, compared to a net income of$116.0 million , or$1.34 net income per basic share and$1.26 per diluted share one year ago. - At
June 30, 2020 ,FibroGen had$716.0 million in cash, cash equivalents, restricted time deposits, investments, and receivables. - Based on our latest forecast, we reiterate our year-end 2020 estimate to be in the range of
$720 to$730 million in cash, cash equivalents, restricted time deposits, investments, and receivables. - Amended China Agreement with AstraZeneca in
July 2020 such that both parties are optimally aligned to maximize the economic value of the roxadustat franchise, with more predictable economics and profitability forFibroGen . - Appointed
Thane Wettig to the newly-created position of Chief Commercial Officer. - Appointed
Aoife Brennan , M.B., B.Ch., President and CEO ofSynlogic, Inc. (NASDAQ:SYBX) to board of directors effectiveAugust 5, 2020 . - Appointed
Ben Cravatt , Ph.D., Professor and the Norton B. Gilula Chair of Chemical Biology in theDepartment of Chemistry atThe Scripps Research Institute to board of directors effectiveAugust 5, 2020 .
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, and improved iron absorption, transport and mobilization. Roxadustat is 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)
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 429,269 | $ | 126,266 | ||||
| Short-term investments | 256,317 | 407,491 | ||||||
| Accounts receivable, net | 26,519 | 28,455 | ||||||
| Inventory | 8,582 | 6,887 | ||||||
| Prepaid expenses and other current assets | 6,481 | 133,391 | ||||||
| Total current assets | 727,168 | 702,490 | ||||||
| Restricted time deposits | 2,072 | 2,072 | ||||||
| Long-term investments | 229 | 61,118 | ||||||
| Property and equipment, net | 36,984 | 42,743 | ||||||
| Finance lease right-of-use assets | 34,368 | 39,602 | ||||||
| Other assets | 6,862 | 9,372 | ||||||
| Total assets | $ | 807,683 | $ | 857,397 | ||||
| Liabilities, stockholders’ equity and non-controlling interests | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,015 | $ | 6,088 | ||||
| Accrued and other liabilities | 50,464 | 83,816 | ||||||
| Deferred revenue | 9,813 | 490 | ||||||
| Finance lease liabilities, current | 12,279 | 12,351 | ||||||
| Total current liabilities | 77,571 | 102,745 | ||||||
| Long-term portion of lease obligations | 940 | 1,141 | ||||||
| Product development obligations | 16,959 | 16,780 | ||||||
| Deferred revenue, net of current | 138,242 | 99,449 | ||||||
| Finance lease liabilities, non-current | 31,586 | 37,610 | ||||||
| Other long-term liabilities | 127,242 | 64,266 | ||||||
| Total liabilities | 392,540 | 321,991 | ||||||
| Total stockholders’ equity | 395,872 | 516,135 | ||||||
| Non-controlling interests | 19,271 | 19,271 | ||||||
| Total equity | 415,143 | 535,406 | ||||||
| Total liabilities, stockholders’ equity and non-controlling interests | $ | 807,683 | $ | 857,397 | ||||
(1) The condensed consolidated balance sheet amounts at
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
| Three Months Ended |
Six Months Ended |
||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| (Unaudited) | |||||||||||||||
| Revenue: | |||||||||||||||
| License revenue | $ | — | $ | 150,581 | $ | — | $ | 150,581 | |||||||
| Development and other revenue | 18,957 | 40,985 | 38,402 | 64,848 | |||||||||||
| Product revenue, net | 15,693 | — | 20,648 | — | |||||||||||
| Drug product revenue | 8,238 | — | 8,238 | — | |||||||||||
| Total revenue | 42,888 | 191,566 | 67,288 | 215,429 | |||||||||||
| Operating costs and expenses: | |||||||||||||||
| Cost of goods sold | 3,076 | — | 4,047 | — | |||||||||||
| Research and development | 61,414 | 52,008 | 116,315 | 102,505 | |||||||||||
| Selling, general and administrative | 63,535 | 26,739 | 113,138 | 48,948 | |||||||||||
| Total operating costs and expenses | 128,025 | 78,747 | 233,500 | 151,453 | |||||||||||
| Income (loss) from operations | (85,137 | ) | 112,819 | (166,212 | ) | 63,976 | |||||||||
| Interest and other, net: | |||||||||||||||
| Interest expense | (651 | ) | (736 | ) | (1,284 | ) | (1,507 | ) | |||||||
| Interest income and other, net | 644 | 4,125 | 3,810 | 8,303 | |||||||||||
| Total interest and other, net | (7 | ) | 3,389 | 2,526 | 6,796 | ||||||||||
| Income (loss) before income taxes | (85,144 | ) | 116,208 | (163,686 | ) | 70,772 | |||||||||
| Provision for (benefit from) income taxes | 169 | 205 | (25 | ) | 180 | ||||||||||
| Net income (loss) | $ | (85,313 | ) | $ | 116,003 | $ | (163,661 | ) | $ | 70,592 | |||||
| Net income (loss) per share | |||||||||||||||
| Basic | $ | (0.95 | ) | $ | 1.34 | $ | (1.84 | ) | $ | 0.82 | |||||
| Diluted | $ | (0.95 | ) | $ | 1.26 | $ | (1.84 | ) | $ | 0.77 | |||||
| Weighted average number of common shares used to calculate net income (loss) per share: | |||||||||||||||
| Basic | 89,451 | 86,445 | 88,835 | 86,077 | |||||||||||
| Diluted | 89,451 | 91,728 | 88,835 | 92,069 | |||||||||||
Contact:
Media Inquiries:
1.703.474.4452
sara.iacovino@gcihealth.com
Investors:
Corporate Strategy / Investor Relations
1.415.978.1434
mtung@fibrogen.com
Source: FibroGen, Inc