FibroGen Reports Third Quarter 2020 Financial Results
- Strong Third Quarter China Roxadustat Net Sales of
- Conference Call Today at
“I am pleased with our progress with roxadustat across a number of fronts; including engagement with the FDA, commercial preparations in the
Key Events in Recent Months and Other Developments
Roxadustat
FibroGen and its partners presented 42 abstracts, including 10 oral presentations and 2 late-breaker poster presentations, at the recentAmerican Society of Nephrology (ASN) Kidney Week 2020 Reimagined conference:
• Two late-breaking abstracts explored the cardiovascular outcomes of patients with anemia of chronic kidney disease (CKD) treated with roxadustat, including associations between achieved hemoglobin levels and risk of Major Adverse Cardiovascular Events (MACE) and MACE+.
• New analyses showed the efficacy of roxadustat across the continuum of patients with anemia of CKD – both on dialysis and not on dialysis – including different dialysis modalities, iron repletion status, and comorbidities.
• Presentations addressed the safety profile of roxadustat related to neoplasms, hypertension, and ophthalmological effects.
• Additional presentations explored the increased risk of red blood cell transfusion at lower hemoglobin levels and the impact of roxadustat on rates of hospitalization due to heart failure.U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease, 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, is under review by the
European Medicines Agency (EMA). Japan sNDA for roxadustat for the treatment of anemia of CKD in non-dialysis-dependent patients is under review by thePharmaceuticals and Medical Devices Agency (PMDA).- Continued enrollment of the 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 LELANTOS, a Phase 3 trial of pamrevlumab in patients with non-ambulatory Duchenne muscular dystrophy (DMD).
- Continued enrollment of the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
- 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 Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) as COVID-19 conditions improve.
- Plan to initiate LELANTOS-2, a Phase 3 trial of pamrevlumab in patients with ambulatory Duchenne muscular dystrophy (DMD) by year-end.
Corporate and Financial
- Total revenue for the third quarter of 2020 was
$44.0 million , as compared to$33.2 million for the third quarter of 2019. The current quarter revenue consisted of$22.7 million in net roxadustat sales inChina ,$20.7 million in development revenue,$2.3 million for sales of bulk drug product, and a net reduction of$1.7 million for certain adjustments. - Net income for the third quarter of 2020 was
$33.0 million , or$0.36 net income per basic and$0.35 per diluted share, compared to a net loss of$49.4 million , or$0.57 net loss per basic and diluted share one year ago. - 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 . As a result, we reversed approximately$84.4 million of co-promotion expenses as a reduction to selling, general and administrative expenses in the third quarter of 2020. - At
September 30, 2020 ,FibroGen had$719.3 million in cash, cash equivalents, restricted time deposits, investments, and receivables. - Based on our latest forecast, we now estimate our year-end 2020 balance for cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of
$770 to$780 million . - Appointed
Percy Carter , MBA, PhD, to the newly-created position of Chief Scientific Officer.
Conference Call and Webcast Details
About Roxadustat
Roxadustat is a first-in-class, oral small molecule HIF-PH inhibitor that promotes erythropoiesis through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production. 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)
2020 |
2019 |
|||||||
| (Unaudited) | (1) |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 532,468 | $ | 126,266 | ||||
| Short-term investments | 155,398 | 407,491 | ||||||
| Accounts receivable, net | 26,252 | 28,455 | ||||||
| Inventory | 11,803 | 6,887 | ||||||
| Prepaid expenses and other current assets | 11,563 | 133,391 | ||||||
| Total current assets | 737,484 | 702,490 | ||||||
| Restricted time deposits | 2,072 | 2,072 | ||||||
| Long-term investments | 247 | 61,118 | ||||||
| Property and equipment, net | 36,153 | 42,743 | ||||||
| Finance lease right-of-use assets | 32,028 | 39,602 | ||||||
| Other assets | 4,031 | 9,372 | ||||||
| Total assets | $ | 812,015 | $ | 857,397 | ||||
| Liabilities, stockholders’ equity and non-controlling interests | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,553 | $ | 6,088 | ||||
| Accrued and other liabilities | 90,572 | 83,816 | ||||||
| Deferred revenue | 7,912 | 490 | ||||||
| Finance lease liabilities, current | 12,311 | 12,351 | ||||||
| Total current liabilities | 118,348 | 102,745 | ||||||
| Long-term portion of lease obligations | 839 | 1,141 | ||||||
| Product development obligations | 17,790 | 16,780 | ||||||
| Deferred revenue, net of current | 137,954 | 99,449 | ||||||
| Finance lease liabilities, non-current | 28,514 | 37,610 | ||||||
| Other long-term liabilities | 37,639 | 64,266 | ||||||
| Total liabilities | 341,084 | 321,991 | ||||||
| Total stockholders’ equity | 451,660 | 516,135 | ||||||
| Non-controlling interests | 19,271 | 19,271 | ||||||
| Total equity | 470,931 | 535,406 | ||||||
| Total liabilities, stockholders’ equity and non-controlling interests | $ | 812,015 | $ | 857,397 | ||||
(1) The condensed consolidated balance sheet amounts at
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
| Three Months Ended |
Nine Months Ended |
||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| (Unaudited) | |||||||||||||||
| Revenue: | |||||||||||||||
| License revenue | $ | — | $ | 11,935 | $ | — | $ | 162,517 | |||||||
| Development and other revenue | 20,663 | 20,660 | 59,065 | 85,507 | |||||||||||
| Product revenue, net | 22,683 | 579 | 43,331 | 579 | |||||||||||
| Drug product revenue | 686 | — | 8,924 | — | |||||||||||
| Total revenue | 44,032 | 33,174 | 111,320 | 248,603 | |||||||||||
| Operating costs and expenses: | |||||||||||||||
| Cost of goods sold | 2,207 | 242 | 6,253 | 242 | |||||||||||
| Research and development | 58,476 | 49,963 | 174,792 | 152,467 | |||||||||||
| Selling, general and administrative | (48,981 | ) | 35,823 | 64,157 | 84,772 | ||||||||||
| Total operating costs and expenses | 11,702 | 86,028 | 245,202 | 237,481 | |||||||||||
| Income (loss) from operations | 32,330 | (52,854 | ) | (133,882 | ) | 11,122 | |||||||||
| Interest and other, net: | |||||||||||||||
| Interest expense | (580 | ) | (702 | ) | (1,864 | ) | (2,209 | ) | |||||||
| Interest income and other, net | 1,469 | 4,193 | 5,279 | 12,496 | |||||||||||
| Total interest and other, net | 889 | 3,491 | 3,415 | 10,287 | |||||||||||
| Income (loss) before income taxes | 33,219 | (49,363 | ) | (130,467 | ) | 21,409 | |||||||||
| Provision for income taxes | 215 | 76 | 190 | 256 | |||||||||||
| Net income (loss) | $ | 33,004 | $ | (49,439 | ) | $ | (130,657 | ) | $ | 21,153 | |||||
| Net income (loss) per share | |||||||||||||||
| Basic | $ | 0.36 | $ | (0.57 | ) | $ | (1.46 | ) | $ | 0.24 | |||||
| Diluted | $ | 0.35 | $ | (0.57 | ) | $ | (1.46 | ) | $ | 0.23 | |||||
| Weighted average number of common shares used to calculate net income (loss) per share: |
|||||||||||||||
| Basic | 90,558 | 87,007 | 89,414 | 86,390 | |||||||||||
| Diluted | 93,678 | 87,007 | 89,414 | 91,995 | |||||||||||
Contacts:
Investors:
Corporate Strategy / Investor Relations
+1.415.978.1434
mtung@fibrogen.com
Media Inquiries:
+1.610.574.9196
jennifer.harrington@gcihealth.com
Source: FibroGen, Inc