FibroGen Reports Fourth Quarter and Full Year 2017 Financial Results
Roxadustat U.S. Phase 3 Program in CKD Anemia Enrollment Completion and Data Readout in 2018
Pamrevlumab Phase 2 IPF Study Achieves Statistically Significant Attenuation of Lung Fibrosis as Measured by Quantitative HRCT
Conference Call and Webcast to be Held Today at
“In 2017, we continued to make significant progress on key clinical and regulatory milestones. Our first NDA submission for roxadustat was accepted for review by the
Recent Developments and Highlights
Roxadustat for CKD Anemia in U.S./ROW
- With our partner
AstraZeneca , we have agreed to a timeline for Phase 3 enrollment completion in the second quarter of 2018 and data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019 - DSMB recommended Phase 3 clinical studies to continue under current protocols with no changes
Roxadustat for CKD Anemia in
- Positive efficacy and safety results reported from two Phase 3 trials
- New Drug Application accepted for filing by the CFDA
Roxadustat for CKD Anemia in
- Our partner Astellas has completed three of six Phase 3 trials
- Topline positive Phase 3 results reported in peritoneal dialysis study
Roxadustat for MDS Anemia
- Enrollment commenced in our first U.S./Europe Phase 3 study for the treatment of anemia in myelodysplastic syndromes (MDS)
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)
- Statistically significant high-resolution computed tomography (HRCT) results achieved in our randomized double-blind, placebo-controlled Phase 2b study
- Positive Phase 2b study results presented at
European Respiratory Society (ERS) International Congress 2017
Pamrevlumab for Pancreatic Cancer
- Reported positive interim Phase 2 open-label results at 2017 ASCO-GI conference showing a majority of pamrevlumab-treated patients converted from unresectable to resectable cancer; all resection evaluations complete and results continue to be favorable for pamrevlumab
Corporate and Financial
- Net loss for the fourth quarter of 2017 was
$22.1 million , or$0.27 per share, compared to$34.0 million , or$0.54 per share one year ago - Net loss for the year ended
December 31, 2017 , was$126.2 million , or$1.73 per share, compared to$61.7 million , or$0.98 per share one year ago - At
December 31, 2017 ,FibroGen had$762.2 million in cash, restricted time deposits, cash equivalents, investments, and receivables- Received a
$15.0 million milestone payment fromAstraZeneca in the fourth quarter of 2017 upon roxadustat NDA submission to CFDA - Completed financings in
April 2017 and inAugust 2017 with net proceeds of$115.1 million and$356.2 million , respectively
- Received a
2018 Outlook
- U.S. Phase 3 CKD anemia enrollment completion in the second quarter of 2018
- U.S. Phase 3 CKD anemia data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019
- NDA approval decision expected in
China for CKD anemia by the end of 2018 - Expect to confirm plans with our partner Astellas for regulatory submissions in
Europe andJapan - Anticipate data readout from two Japan Phase 3 hemodialysis studies, a long-term conversion study and a correction (ESA-naïve) study, in the first quarter of 2018
- Anticipate initiation of roxadustat Phase 2/3 clinical study in
China for anemia associated with MDS in first half of 2018 - Expect to present HRCT and health-related quality-of-life results from the IPF Phase 2b trial at an upcoming scientific conference
- Design pivotal trials for IPF and locally advanced pancreatic cancer
Conference Call and Webcast Details
About Roxadustat
Roxadustat is a first-in-class oral therapeutic in global Phase 3 clinical development as a treatment for anemia associated with chronic kidney disease (CKD) with the potential to offer a safer and more effective, convenient, and accessible treatment than current therapies. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), promotes erythropoiesis, or the production of red bloods, by increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin, including in the presence of inflammation and without need for supplemental intravenous iron.
The roxadustat Phase 3 program is the largest Phase 3 clinical program in anemia to date, and is supported by extensive Phase 2 results demonstrating correction and maintenance of hemoglobin levels in anemia in multiple subpopulations of CKD dialysis and non-dialysis patients. A New Drug Application (NDA) has been accepted for review by the
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 of the company's product candidates pamrevlumab and roxadustat, the potential safety and efficacy profile of our product candidates, and our clinical, regulatory, and commercial plans, 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,” “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, 2017 | December 31, 2016 | |||||||
| (Unaudited) | (1) |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 673,658 | $ | 173,782 | ||||
| Short-term investments | 62,060 | 79,397 | ||||||
| Accounts receivable | 8,452 | 10,448 | ||||||
| Prepaid expenses and other current assets | 4,800 | 2,889 | ||||||
| Total current assets | 748,970 | 266,516 | ||||||
| Restricted time deposits | 5,181 | 6,217 | ||||||
| Long-term investments | 10,506 | 71,010 | ||||||
| Property and equipment, net | 129,476 | 123,657 | ||||||
| Other assets | 4,517 | 2,152 | ||||||
| Total assets | $ | 898,650 | $ | 469,552 | ||||
| Liabilities, stockholders' equity and non-controlling interests | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,509 | $ | 6,223 | ||||
| Accrued liabilities | 63,781 | 50,914 | ||||||
| Deferred revenue | 7,968 | 7,988 | ||||||
| Total current liabilities | 77,258 | 65,125 | ||||||
| Long-term portion of lease financing obligations | 97,763 | 97,352 | ||||||
| Product development obligations | 17,244 | 14,854 | ||||||
| Deferred rent | 3,657 | 4,212 | ||||||
| Deferred revenue, net of current | 112,231 | 106,709 | ||||||
| Other long-term liabilities | 8,047 | 6,191 | ||||||
| Total liabilities | 316,200 | 294,443 | ||||||
| Total stockholders’ equity | 563,179 | 155,838 | ||||||
| Non-controlling interests | 19,271 | 19,271 | ||||||
| Total equity | 582,450 | 175,109 | ||||||
| Total liabilities, stockholders' equity and non-controlling interests | $ | 898,650 | $ | 469,552 | ||||
(1) The condensed consolidated balance sheet amounts at December 31, 2016 are derived from audited financial statements.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||||||
| (Unaudited) | (Unaudited) | (1) |
||||||||||||||||||
| Revenue: | ||||||||||||||||||||
| License and milestone revenue | $ | 35,126 | $ | 23,551 | $ | 96,056 | $ | 137,352 | ||||||||||||
| Collaboration services and other revenue | 7,383 | 8,362 | 29,612 | 42,225 | ||||||||||||||||
| Total revenue | 42,509 | 31,913 | 125,668 | 179,577 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 52,469 | 50,607 | 196,517 | 187,206 | ||||||||||||||||
| General and administrative | 13,851 | 12,585 | 51,760 | 46,025 | ||||||||||||||||
| Total operating expenses | 66,320 | 63,192 | 248,277 | 233,231 | ||||||||||||||||
| Loss from operations | (23,811 | ) | (31,279 | ) | (122,609 | ) | (53,654 | ) | ||||||||||||
| Interest and other, net: | ||||||||||||||||||||
| Interest expense | (1,806 | ) | (2,750 | ) | (9,706 | ) | (10,725 | ) | ||||||||||||
| Interest income and other, net | 3,651 | 217 | 6,433 | 2,628 | ||||||||||||||||
| Total interest and other, net | 1,845 | (2,533 | ) | (3,273 | ) | (8,097 | ) | |||||||||||||
| Loss before income taxes | (21,966 | ) | (33,812 | ) | (125,882 | ) | (61,751 | ) | ||||||||||||
| Provision for (benefit from) income taxes | 156 | 189 | 321 | (71 | ) | |||||||||||||||
| Net loss | $ | (22,122 | ) | $ | (34,001 | ) | $ | (126,203 | ) | $ | (61,680 | ) | ||||||||
| Net loss per share - basic and diluted | $ | (0.27 | ) | $ | (0.54 | ) | $ | (1.73 | ) | $ | (0.98 | ) | ||||||||
| Weighted average number of common shares used to calculate net loss per share - basic and diluted | 82,151 | 63,345 | 72,987 | 62,744 | ||||||||||||||||
(1) The condensed consolidated statements of operations amounts for the year ended December 31, 2016 are derived from audited financial statements.
Contact
Vice President, Investor Relations and Corporate Communications
1 (415) 978-1433
kbergman@fibrogen.com