Enrollment Completed in Placebo-Controlled Study of FG-3019 (Pamrevlumab) in IPF
China Phase 3 Top Line Data Expected by Year-End 2016
–Webcast Conference Call Scheduled for 4:30pm EDT Today–
SAN FRANCISCO, Aug. 08, 2016 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) (“FibroGen”), a research-based biopharmaceutical company, today reported financial results for the quarter ended June 30, 2016.
“We continue to develop our multiple key programs across focused therapeutic areas,” said Thomas B. Neff, chief executive officer of FibroGen. “Working jointly with our partners, Astellas and AstraZeneca, we have advanced global clinical development for roxadustat for treatment of anemia in chronic kidney disease patients to Phase 3 in four independent regulatory pathways − the U.S., Europe, China, and Japan − and remain on track to initiate new drug application submissions in 2016 in China, and in 2018 in the U.S. We have completed enrollment in the placebo-controlled portion of our Phase 2 study of FG-3019 (now known as pamrevlumab) for treatment of idiopathic pulmonary fibrosis, and expect to report data from this study in the middle of next year, and our Phase 2 studies in pancreatic cancer and Duchenne muscular dystrophy continue to progress.”
Program Updates
Anemia of Chronic Kidney Disease (CKD): roxadustat (FG-4592)
- China Phase 3 enrollment on track: Completed enrollment in a 300-patient dialysis study, one of two Phase 3 pivotal trials in China; expect to complete enrollment in the second study, a 150-patient non-dialysis study now over 70% enrolled, in Q3 of this year. We expect first reportable data in each of the Phase 3 studies by the end of the year.
- The independent data safety monitoring board overseeing roxadustat U.S and Europe Phase 3 studies met in July 2016 to review the roxadustat safety data, and confirmed that the trials should proceed with current Phase 3 protocols without modification.
- Continue to expect to initiate new drug application submissions for roxadustat in 2016 for China and in 2018 for the U.S.
Fibrosis and Other Fibroproliferative Diseases: pamrevlumab (FG-3019)
- Completed enrollment in the 48-week main study portion of a placebo-controlled Phase 2 trial for treatment of IPF. We plan to report topline data for the entire study in mid-2017, including the six month combination therapy sub-study in which patients will receive pamrevlumab in combination with pirfenidone or nintedanib, which will continue to enroll until the end of the year.
- Continue to advance our Phase 2 trial in patients with unresectable, locally advanced pancreatic cancer, and anticipate that we will present available findings early next year.
- Enrollment continues in our open-label Phase 2 study of pamrevlumab in non-ambulatory Duchenne muscular dystrophy (DMD) patients.
Financial Highlights
- Net income per basic share for the quarter ended June 30, 2016, was $0.39, and $0.35 on a per diluted share basis.
- At June 30, 2016, FibroGen had $368.6 million of cash, cash equivalents, investments, receivables, and restricted cash.
- During the quarter ended June 30, 2016, we received a $62.0 million upfront payment under the AstraZeneca Agreement. We also recognized $10.0 million milestone revenue under the Astellas Agreement, which payment was received in early July 2016.
Conference Call Details
FibroGen will host a conference call and webcast today, August 8, 2016, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time), to discuss financial results and provide a business update. Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. To access the conference call by telephone, please dial (888) 771-4371 (U.S. and Canada) or (847) 585-4405 (international), reference the FibroGen Q2 2016 conference call, and use the passcode 43075857. It is recommended that listeners register 15 minutes before the scheduled start time to ensure a timely connection. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (U.S. and Canada) or (630) 652-3042 (international), reference the FibroGen Q2 2016 conference call, and use the passcode 43075857#.
About FibroGen
FibroGen is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics to treat serious unmet medical needs. The company utilizes its extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate development programs in multiple therapeutic areas. Its most advanced product candidate, roxadustat (FG-4592), is an oral small molecule inhibitor of HIF prolyl hydroxylases (HIF-PHs) in Phase 3 clinical development for the treatment of anemia in CKD. A second product candidate, pamrevlumab (FG-3019), our fully-human monoclonal antibody that inhibits the activity of CTGF, is in Phase 2 clinical development for the treatment of IPF, pancreatic cancer, and DMD. For more information please visit: www.fibrogen.com.
Forward-Looking Statements
This release contains forward-looking statements, including statements regarding our clinical data reporting, potential milestones, clinical plans, regulatory submissions, and financial projections. 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 clinical programs, including enrollment of the Phase 3 clinical trials for roxadustat in CKD, the continued progress of our plans and programs in China, the outcome of regulatory filings for anemia associated with myelodysplastic syndrome, the enrollment and results from ongoing clinical trials for pamrevlumab in IPF, pancreatic cancer, and DMD, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
| Condensed Consolidated Balance Sheets | |||||||||||
| (In thousands) | |||||||||||
| June 30, 2016 | December 31, 2015 | ||||||||||
| (Unaudited) | (1 | ) | |||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 190,411 | $ | 153,324 | |||||||
| Short-term investments | 40,105 | 27,847 | |||||||||
| Accounts receivable | 18,088 | 15,405 | |||||||||
| Prepaid expenses and other current assets | 3,705 | 3,988 | |||||||||
| Total current assets | 252,309 | 200,564 | |||||||||
| Restricted cash | 7,254 | 7,254 | |||||||||
| Long-term investments | 111,540 | 131,720 | |||||||||
| Property and equipment, net | 126,264 | 129,020 | |||||||||
| Other assets | 1,762 | 2,016 | |||||||||
| Total assets | $ | 499,129 | $ | 470,574 | |||||||
| Liabilities, stockholders' equity and non-controlling interests | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 3,474 | $ | 6,521 | |||||||
| Accrued liabilities | 47,942 | 47,932 | |||||||||
| Deferred revenue | 15,027 | 12,728 | |||||||||
| Total current liabilities | 66,443 | 67,181 | |||||||||
| Long-term portion of lease financing obligations | 97,395 | 97,042 | |||||||||
| Product development obligations | 15,515 | 15,085 | |||||||||
| Deferred rent | 4,461 | 4,702 | |||||||||
| Deferred revenue, net of current | 97,947 | 85,132 | |||||||||
| Other long-term liabilities | 4,991 | 4,607 | |||||||||
| Total liabilities | 286,752 | 273,749 | |||||||||
| Total stockholders’ equity | 193,106 | 177,554 | |||||||||
| Non-controlling interests | 19,271 | 19,271 | |||||||||
| Total equity | 212,377 | 196,825 | |||||||||
| Total liabilities, stockholders' equity and non-controlling interests | $ | 499,129 | $ | 470,574 | |||||||
(1) The condensed consolidated balance sheet amounts at December 31, 2015 are derived from audited financial statements.
| Condensed Consolidated Statements of Operations | |||||||||||||||||||
| (In thousands, except per share data) | |||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||||||
| (Unaudited) | |||||||||||||||||||
| Revenue: | |||||||||||||||||||
| License and milestone revenue | $ | 73,197 | $ | 106,879 | $ | 92,935 | $ | 118,385 | |||||||||||
| Collaboration services and other revenue | 16,083 | 13,671 | 24,628 | 18,463 | |||||||||||||||
| Total revenue | 89,280 | 120,550 | 117,563 | 136,848 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 52,392 | 51,555 | 96,041 | 102,094 | |||||||||||||||
| General and administrative | 10,376 | 9,680 | 21,794 | 20,162 | |||||||||||||||
| Total operating expenses | 62,768 | 61,235 | 117,835 | 122,256 | |||||||||||||||
| Income (loss) from operations | 26,512 | 59,315 | (272 | ) | 14,592 | ||||||||||||||
| Interest and other, net: | |||||||||||||||||||
| Interest expense | (2,438 | ) | (2,762 | ) | (5,215 | ) | (5,520 | ) | |||||||||||
| Interest income and other, net | 129 | 707 | 1,545 | 1,550 | |||||||||||||||
| Total interest and other, net | (2,309 | ) | (2,055 | ) | (3,670 | ) | (3,970 | ) | |||||||||||
| Income (loss) before income taxes | 24,203 | 57,260 | (3,942 | ) | 10,622 | ||||||||||||||
| Provision for (benefit from) income taxes | (113 | ) | 205 | (418 | ) | (66 | ) | ||||||||||||
| Net income (loss) | $ | 24,316 | $ | 57,055 | $ | (3,524 | ) | $ | 10,688 | ||||||||||
| Net income (loss) per share | |||||||||||||||||||
| Basic | $ | 0.39 | $ | 0.95 | $ | (0.06 | ) | $ | 0.18 | ||||||||||
| Diluted | $ | 0.35 | $ | 0.83 | $ | (0.06 | ) | $ | 0.15 | ||||||||||
| Weighted average number of common shares used to calculate net income (loss) per share: | |||||||||||||||||||
| Basic | 62,582 | 59,798 | 62,383 | 59,499 | |||||||||||||||
| Diluted | 69,022 | 68,752 | 62,383 | 69,354 | |||||||||||||||