SAN FRANCISCO--(BUSINESS WIRE)--May 12, 2015--
FibroGen, Inc. (NASDAQ:FGEN) (“FibroGen”), a research-based
biopharmaceutical company, today reported financial results for the
quarter ended March 31, 2015.
“FibroGen and its partners, AstraZeneca and Astellas, continue to make
excellent progress in the global development of roxadustat for the
treatment of anemia in patients with chronic kidney disease,” said
Thomas B. Neff, chief executive officer of FibroGen. “Patient enrollment
in the seven Phase 3 studies required for approval in the U.S. and
Europe is advancing as planned. In China, we expect to begin patient
enrollment in both Phase 3 studies required for regulatory approval in
the fourth quarter of 2015. In April 2015, the roxadustat data safety
monitoring board completed its scheduled quarterly review of the data
collected to date from the seven active Phase 3 roxadustat studies and
recommended that the program proceed with no protocol changes. We expect
to submit roxadustat regulatory filings in China in 2016 and in the U.S.
in 2018.”
Other Program Updates
FG-3019
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In idiopathic pulmonary fibrosis, we continue to enroll patients in a
136 patient Phase 2 placebo controlled study in the U.S. and expect to
open additional clinical sites outside of the U.S. in the third
quarter of 2015.
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In pancreatic cancer, we are evaluating in an open-label Phase 2 study
the ability of FG-3019, in combination with gemcitabine and
nab-paclitaxel, to convert inoperable pancreatic cancer to operable
cancer.
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In Duchenne muscular dystrophy, following an expert advisory panel
review completed in March 2015, we plan to file an IND, and to
commence a Phase 2 study in non-ambulatory patients in the second half
of 2015.
FG-5200 (Corneal Implant)
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A pilot study of a corneal implant containing our proprietary human
collagen Type III is entering its seventh year with study patients
having undergone successful replacement surgery and continuing to have
vision regain. We plan to advance the development of our FG-5200
corneal implant in China and expect to receive responses from China
regulatory authorities regarding the development priority status in
the coming months.
Financial Highlights
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The final audited reports of two long-term roxadustat pre-clinical
carcinogenicity studies were completed, further supporting the safety
profile of roxadustat and triggering a $15.0 million milestone payment
by AstraZeneca.
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Revenue was $16.3 million and operating expenses were $61.0 million
for the first quarter of 2015. Net loss per share for the first
quarter of 2015 was $(0.78) based on 59.2 million shares outstanding
compared to net loss per share of $(0.27) for the first quarter of
2014 based on the same number of shares outstanding on a pro-forma
basis.
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On March 31, 2015, we had $296.4 million of cash, cash equivalents,
investments, and receivables. In addition to the milestone payment of
$15.0 million received last week, we expect to receive a
non-contingent license payment of $120.0 million from AstraZeneca in
the second quarter of 2015.
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Under the agreement with AstraZeneca, our total funding obligations
for roxadustat development in chronic kidney disease (CKD) outside
China are limited to $116.5 million, of which $52.1 million remained
at the end of the first quarter of 2015. Based on current internal and
partner projections, we continue to expect that our funding obligation
will be met by the fourth quarter of 2015. Thereafter, Astellas and
AstraZeneca will be responsible for funding roxadustat development in
CKD through launch for all territories, excluding China.
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. We have capitalized on our extensive
experience in fibrosis and hypoxia-inducible factor (HIF) biology to
generate multiple programs targeting various therapeutic areas. Our most
advanced product candidate, roxadustat, or 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 chronic kidney
disease (CKD). Our second product candidate, FG-3019, is a monoclonal
antibody in Phase 2 clinical development for the treatment of idiopathic
pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis.
Forward Looking Statements
This release contains forward-looking statements, including statements
regarding our milestones, clinical plans and financial projections. Our
actual results may differ materially from those indicated in these
forward-looking statements due to risks and uncertainties, including the
continued progress and timing of our various clinical programs,
including the timing of enrollment of the Phase 3 clinical trials for
roxadustat in CKD and the initiation and enrollment in ongoing and IND
filing for planned clinical trials for FG-3019 in idiopathic pulmonary
fibrosis and pancreatic cancer, and Duchenne muscular dystrophy,
respectively; the potential to achieve and receive approximately $120
million in non-contingent license payments from AstraZeneca in the
second quarter of 2015; the continued progress of our plans and programs
in China; and other matters that are described in our Annual Report on
Form 10-K for the year ended December 31, 2014 filed with the Securities
and Exchange Commission on March 26, 2015, including the risk factors
set forth in that filing. Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date of this release and we undertake no obligation to update any
forward-looking statement in this press release, except as required by
law.
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Condensed Consolidated Balance Sheets
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(In thousands)
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March 31,
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December 31,
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2015
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2014
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(Unaudited)
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(1)
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Assets
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Current assets:
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Cash and cash equivalents
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$
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128,369
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$
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165,455
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Short-term investments
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14,322
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14,364
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Accounts receivable
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6,963
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13,453
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Prepaid expenses and other current assets
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5,746
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4,966
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Total current assets
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155,400
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198,238
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Restricted cash
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7,254
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7,254
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Long-term investments
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139,518
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144,269
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Property and equipment, net
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131,660
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132,171
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Other assets
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1,708
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1,596
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Total assets
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$
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435,540
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$
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483,528
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Liabilities, stockholders' equity and non-controlling interests
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Current liabilities:
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Accounts payable
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$
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2,433
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$
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4,551
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Accrued liabilities
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42,466
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48,985
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Deferred revenue
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9,058
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9,218
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Total current liabilities
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53,957
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62,754
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Long-term portion of lease financing obligations
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96,873
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96,818
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Product development obligations
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14,774
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16,465
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Deferred rent
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5,024
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5,131
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Deferred revenue, net of current
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60,326
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60,988
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Other long-term liabilities
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699
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696
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Total stockholders’ equity
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184,616
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221,405
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Non-controlling interests
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19,271
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19,271
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Total equity
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203,887
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240,676
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Total liabilities and equity
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$
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435,540
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$
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483,528
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(1) The condensed consolidated balance sheet amounts at
December 31, 2014 are derived from audited financial statements.
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Condensed Consolidated Statements of Operations
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(In thousands, except per share data, unaudited)
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Three Months Ended March 31,
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2015
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2014
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Revenue:
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License and milestone revenue
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$
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11,506
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$
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14,685
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Collaboration services and other revenue
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4,792
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3,191
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Total revenue
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16,298
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17,876
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Operating expenses:
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Research and development
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50,539
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25,650
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General and administrative
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10,482
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6,432
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Total operating expenses
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61,021
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32,082
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Loss from operations
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(44,723
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)
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(14,206
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)
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Interest expense
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(2,758
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)
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(2,726
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)
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Interest and other income, net
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843
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692
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Loss before income taxes
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(46,638
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)
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(16,240
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)
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Benefit from income taxes
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271
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-
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Net loss
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$
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(46,367
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)
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$
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(16,240
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)
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Net loss per basic and diluted share
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$
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(0.78
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)
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$
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(1.23
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)
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Weighted average number of common shares used in net loss per
basic and diluted share
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59,197
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13,210
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(2)
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(2) On a pro-forma basis, the 13.2 million weighted shares
would be reported as 59.2 million shares based on the following:
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Common Shares
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(In Millions)
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Weighted average shares as of March 31, 2014
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13.2
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Shares sold in initial public offering
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9.3
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Concurrent private placement - AstraZeneca
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1.1
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Conversion of preferred shares upon initial public offering
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33.9
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Conversion of European subsidiary shares
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1.0
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Option exercises
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0.7
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Weighted average shares as of March 31, 2015
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59.2
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ABOUT NON-GAAP FINANCIAL MEASURES
To supplement our condensed consolidated financial statements, which are
prepared and presented in accordance with U.S. generally accepted
accounting principles ("GAAP"), we present non-GAAP net loss per share
for the first quarter of 2014 on a pro-forma basis. The presentation of
this financial information is not intended to be considered in isolation
or as a substitute for, or superior to, the financial information
prepared and presented in accordance with GAAP.
We define non-GAAP net loss per share as GAAP net loss for the three
months ended March 31, 2014 divided by the weighted average number of
common shares outstanding for the same period in 2015. Weighted average
common shares as of March 31, 2015 were 59.2 million. With a starting
point of 13.2 million weighted shares as of March 31, 2014, we sold 9.3
million shares in our initial public offering in November 2014,
concurrent private placement of 1.1 million shares with AstraZeneca. The
resulting automatic conversion of the Company’s outstanding convertible
preferred stock into 33.9 million shares of common stock, plus the
resulting exchange of our European subsidiary’s preferred shares into
1.0 million shares of common stock, and 0.7 million shares related to
option exercises, resulted in 35.4 million converted shares. The total
of the above results in 59.2 million weighted average common shares at
March 31, 2015, compared to 13.2 million common shares as of March 31,
2014.
Source: FibroGen, Inc.
FibroGen, Inc.
Greg Mann, 415-978-1433
gmann@fibrogen.com
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