FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical
company, today reported financial results for the first quarter of
2017 and provided an update on the company’s recent developments.
“This is an exciting time for FibroGen, as we
prepare for an eventful second half of the year across our
pipeline. In the third quarter of 2017, we anticipate reporting
topline Phase 2 clinical trial results for pamrevlumab in
idiopathic pulmonary fibrosis patients, and we are preparing to
complete submission of the roxadustat China NDA for the treatment
of anemia in non-dialysis and dialysis CKD patients,” said Thomas
B. Neff, FibroGen’s Chief Executive Officer. “We are gratified by
the support we received from new and current investors in our
recent equity offering, which raised $115.1 million in net
proceeds. This financing will support our plans to increase the
number of studies and accelerate development in other anemia
categories in China, including for roxadustat in anemias in certain
oncology settings.”
Recent Developments AND
HIGHLIGHTSU.S. Roxadustat for Anemia in Chronic
Kidney Disease (CKD)
- The independent data safety monitoring board (DSMB) recommended
in April that all trials continue with no modifications to current
protocols.
- On track to submit the NDA for roxadustat in the U.S. in
2018.
U.S. Roxadustat for Anemia in
Myelodysplastic Syndromes (MDS)
- Received approval from FDA to conduct Phase 3 study for the
treatment of anemia in MDS. This study is planned to start in the
third quarter of 2017.
China Roxadustat Anemia in CKD: Dialysis
and Non-Dialysis
- Positive Phase 3 results from two pivotal trials in China were
announced on January 30, 2017.
- On target for NDA submission in China in the third quarter of
2017.
China Roxadustat for Myelodysplastic
Syndromes (MDS)
- Received approval from the CFDA to undertake a Phase 2/3 study
for the treatment of anemia in MDS. We plan to start this study in
the fourth quarter of 2017.
Pamrevlumab in Idiopathic
Pulmonary Fibrosis (IPF)
- On track to report topline Phase 2 study results from a
double-blind, placebo-controlled study, and a double-blind,
active-controlled sub-study for the treatment of IPF in the third
quarter of 2017.
Pamrevlumab in Pancreatic
Cancer
- Positive findings from an ongoing open-label, randomized Phase
1/2 study in locally advanced pancreatic cancer were presented at
the 2017 Gastrointestinal Cancers Symposium in January.
- Positive results from a prior Phase 1/2 trial were published
online in January 2017 in the Journal of Cancer Clinical
Trials.
Corporate and Financial
Highlights
- Net loss per basic and diluted share for the quarter ended
March 31, 2017 was $0.52, as compared to $0.45 a year ago.
- At March 31, 2017, FibroGen had $314.2 million of cash,
restricted time deposits, cash equivalents, investments, and
receivables.
- In addition, we completed an equity financing on April 11, 2017
that generated $115.1 million in net proceeds.
Conference Call Details FibroGen
will host a conference call and webcast today, May 9, 2017, 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 1 (888) 771-4371 (U.S.
and Canada) or 1 (847) 585-4405 (international), reference the
FibroGen First Quarter 2017 conference call, and use the
confirmation number 44595888. 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 (domestic) or (630) 652-3042
(international), and use the confirmation number 4459 5888#.
About RoxadustatRoxadustat
(FG-4592) is a first-in-class, orally administered small molecule
currently in global Phase 3 clinical development as a potential
therapy for anemia associated with chronic kidney disease (CKD).
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI) that promotes erythropoiesis through increasing
endogenous erythropoietin, improving iron regulation, and reducing
hepcidin. Administration of roxadustat has been shown to induce
coordinated erythropoiesis – increasing red blood cell count while
maintaining plasma erythropoietin levels within or near normal
physiologic range in multiple subpopulations of CKD patients –
including in the presence of inflammation and without a need for
supplemental intravenous iron.
Roxadustat is currently advancing through Phase 3
clinical trials worldwide, supported by extensive Phase 2 clinical
data demonstrating correction and maintenance of hemoglobin levels
in multiple subpopulations of CKD anemia patients. To date,
roxadustat has been evaluated in Phase 1 and Phase 2 studies
involving more than 1,400 subjects. Globally, a total of 17 studies
are currently underway involving a total of more than 11,000
patients. Of these, 15 are Phase 3 pivotal studies comprising
10,400 patients, and are currently being conducted to support
independent regulatory approvals of roxadustat in both non-dialysis
and dialysis CKD patients in the U.S., Europe, Japan, and China.
Later this year, roxadustat will also enter a Phase 3 clinical
trial in the U.S., and a Phase 2/3 trial in China, for the
treatment of anemia in patients with myelodysplastic syndromes
(MDS). For information about roxadustat studies currently
recruiting patients, please visit www.clinicaltrials.gov.
About PamrevlumabPamrevlumab
(FG-3019) is an investigational therapeutic antibody developed by
FibroGen to inhibit the activity of connective tissue growth factor
(CTGF), a common factor in chronic fibrotic and proliferative
disorders characterized by persistent and excessive scarring that
can lead to organ dysfunction and failure. FibroGen is currently
conducting clinical studies of pamrevlumab in idiopathic pulmonary
fibrosis, pancreatic cancer, and Duchenne muscular dystrophy (DMD).
In desmoplastic or fibrotic cancers, such as pancreatic cancer,
CTGF in the extensive fibrous stroma associated with the tumor
promotes abnormal proliferation of stromal cells and tumor cells.
Studies in a transgenic mouse model of pancreatic cancer indicate
that treatment with pamrevlumab in combination with chemotherapy
may enhance the efficacy of chemotherapy and improve survival. For
information about pamrevlumab studies currently recruiting
patients, please visit www.clinicaltrials.gov.
About FibroGen, Inc.FibroGen,
Inc., headquartered in San Francisco with subsidiary offices in
Beijing and Shanghai, PRC, is a leading science-based
biopharmaceutical company discovering and developing a pipeline of
first-in-class therapeutics. The company applies its
pioneering expertise in fibrosis and hypoxia-inducible factor (HIF)
biology and clinical development to advance innovative medicines
for the treatment of anemia, fibrotic disease, and cancer.
Roxadustat, the company’s most advanced product candidate, is an
oral small molecule inhibitor of HIF prolyl hydroxylase activity in
Phase 3 clinical development for the treatment of anemia in chronic
kidney disease (CKD) and is entering Phase 3 development for anemia
in lower risk myelodysplastic syndromes (MDS). Pamrevlumab, a
fully-human monoclonal antibody that inhibits the activity of
connective tissue growth factor (CTGF), is in Phase 2 clinical
development for the treatment of idiopathic pulmonary fibrosis
(IPF), pancreatic cancer, and Duchenne muscular dystrophy (DMD).
FibroGen is also developing a biosynthetic cornea in China. For
more information, please visit www.fibrogen.com.
Forward-Looking StatementsThis
release contains forward-looking statements regarding our strategy,
future plans and prospects, including statements regarding the
development of the Company's product candidates, roxadustat and
pamrevlumab, the potential safety and efficacy profile of our
product candidates, the timelines for reporting of our clinical
data reporting, potential milestones, and regulatory submissions,
our clinical plans and our financial projections. 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,” “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 non-clinical
and clinical programs, including enrollment of our Phase 3 trials
and other clinical trials, and our collaboration partners’ clinical
trials for roxadustat in anemia associated with CKD, the continued
progress of our plans and programs in China, clinical development
of and regulatory filing outcomes for anemia associated with
myelodysplastic syndrome, the enrollment and results from ongoing
clinical trials for pamrevlumab in IPF, and pancreatic cancer, and
other matters that are described in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2016, and our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2017, 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) |
|
|
|
|
|
|
|
March 31, 2017 |
|
|
December 31, 2016 |
|
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
170,598 |
|
|
$ |
173,782 |
|
|
Short-term investments |
|
72,824 |
|
|
|
79,397 |
|
|
Accounts
receivable |
|
7,248 |
|
|
|
10,448 |
|
|
Prepaid
expenses and other current assets |
|
5,911 |
|
|
|
2,889 |
|
|
Total
current assets |
|
256,581 |
|
|
|
266,516 |
|
|
|
|
|
|
|
|
|
|
Restricted time
deposits |
|
6,217 |
|
|
|
6,217 |
|
|
Long-term
investments |
|
53,155 |
|
|
|
71,010 |
|
|
Property and equipment,
net |
|
122,818 |
|
|
|
123,657 |
|
|
Other assets |
|
2,985 |
|
|
|
2,152 |
|
|
Total assets |
$ |
441,756 |
|
|
$ |
469,552 |
|
|
|
|
|
|
|
|
|
|
Liabilities,
stockholders' equity and non-controlling interests |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
$ |
2,950 |
|
|
$ |
6,223 |
|
|
Accrued
liabilities |
|
49,179 |
|
|
|
50,914 |
|
|
Deferred
revenue |
|
7,984 |
|
|
|
7,988 |
|
|
Total
current liabilities |
|
60,113 |
|
|
|
65,125 |
|
|
|
|
|
|
|
|
|
|
Long-term portion of
lease financing obligations |
|
97,536 |
|
|
|
97,352 |
|
|
Product development
obligations |
|
15,152 |
|
|
|
14,854 |
|
|
Deferred rent |
|
4,075 |
|
|
|
4,212 |
|
|
Deferred revenue, net
of current |
|
108,068 |
|
|
|
106,709 |
|
|
Other long-term
liabilities |
|
5,840 |
|
|
|
6,191 |
|
|
Total
liabilities |
|
290,784 |
|
|
|
294,443 |
|
|
|
|
|
|
|
|
|
|
Total stockholders’
equity |
|
131,701 |
|
|
|
155,838 |
|
|
Non-controlling
interests |
|
19,271 |
|
|
|
19,271 |
|
|
Total equity |
|
150,972 |
|
|
|
175,109 |
|
|
Total
liabilities, stockholders' equity and non-controlling
interests |
$ |
441,756 |
|
|
$ |
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 March 31, |
|
|
2017 |
|
|
2016 |
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
License
and milestone revenue |
$ |
|
19,581 |
|
|
$ |
|
19,738 |
|
Collaboration services and other revenue |
|
|
7,310 |
|
|
|
|
8,544 |
|
Total
revenue |
|
|
26,891 |
|
|
|
|
28,282 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
46,732 |
|
|
|
|
43,650 |
|
General
and administrative |
|
|
11,530 |
|
|
|
|
11,417 |
|
Total
operating expenses |
|
|
58,262 |
|
|
|
|
55,067 |
|
Loss from
operations |
|
|
(31,371 |
) |
|
|
|
(26,785 |
) |
Interest and
other, net: |
|
|
|
|
|
|
|
|
|
Interest
expense |
|
|
(2,375 |
) |
|
|
|
(2,777 |
) |
Interest
income and other, net |
|
|
645 |
|
|
|
|
1,416 |
|
Total
interest and other, net |
|
|
(1,730 |
) |
|
|
|
(1,361 |
) |
Loss before
income taxes |
|
|
(33,101 |
) |
|
|
|
(28,146 |
) |
Provision for (benefit
from) income taxes |
|
|
60 |
|
|
|
|
(305 |
) |
Net
loss |
$ |
|
(33,161 |
) |
|
$ |
|
(27,841 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
|
$ |
(0.52 |
) |
|
|
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares used to calculate net loss per share - basic and
diluted |
|
|
64,037 |
|
|
|
|
62,184 |
|
Contact
FibroGen, Inc.
Karen L. Bergman
VP, Investor Relations and Corporate Communications
+1 (415) 978-1433
kbergman@fibrogen.com
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