Roxadustat U.S. Phase 3 Topline Clinical
Data Readout on Track for Fourth Quarter of 2018
FibroGen, Inc. (NASDAQ: FGEN), a biopharmaceutical company, today
reported financial results for the second quarter of 2018 and
provided an update on the company’s recent developments.
“We are encouraged by the progress of our discussions with the
FDA in advancing the development of pamrevlumab in IPF and locally
advanced pancreatic cancer into pivotal Phase 3 clinical trials,
including with the potential for accelerated approval in LAPC,”
said Thomas B. Neff, FibroGen’s Chief Executive Officer.
“Meanwhile, we are on track with timelines for regulatory
submission of roxadustat for the treatment of CKD anemia in
multiple regions, as we have made significant progress toward
approval in China, and our studies for U.S. approval are completing
and will read out in the fourth quarter of this year.”
Recent Developments and
HighlightsRoxadustat for Anemia
in Chronic Kidney Disease (CKD) in the
U.S./EU
- U.S. Phase 3 trial enrollment completed
- Topline Phase 3 clinical data readout on target for the fourth
quarter of 2018
- Pooled MACE safety data anticipated in early 2019
- New Drug Application (NDA) submission to the U.S. Food and Drug
Administration (FDA) on target for the first half of 2019
- In its most recent and final review, the data safety monitoring
board recommended Phase 3 clinical studies continue under current
protocols with no changes
Roxadustat for Anemia in CKD in China
- NDA approval decision by the State Drug Administration (SDA)
anticipated by year-end 2018
Roxadustat for Anemia Associated with MDS in
China
- Patient dosing underway in Phase 2/3 study
Roxadustat for Anemia in CKD in Japan
- Astellas and FibroGen announced positive topline results from
double-blind Phase 3 study in hemodialysis CKD patients in May
2018
- Astellas plans to submit NDA for anemia associated with
dialysis-dependent CKD in 2018
- Astellas expects to announce topline data readout from the
first of two ongoing non-dialysis-dependent CKD Phase 3 studies in
the fourth quarter of 2018
Pamrevlumab for Idiopathic Pulmonary Fibrosis
(IPF)
- Positive Phase 2b efficacy and safety results (improvements in
lung function (FVC), quantitative measure of fibrosis (HRCT)
and quality of life (SGRQ)) reported in multiple poster
presentations at the 2018 American Thoracic Society (ATS)
Conference in May 2018
- Met with the FDA on IPF Phase 3 design; Phase 3 study planned
to begin in early 2019
Pamrevlumab for Pancreatic Cancer
- Positive Phase 1/2 clinical results showing higher rates of
eligibility for surgical resection and tumor resection rates in
patients treated with roxadustat, presented at the 2018 American
Society of Clinical Oncology (ASCO) Annual Meeting in June
2018
- Agreement with the FDA on pivotal trial design with
approximately 260 patients; trial planned to begin in early
2019
Corporate and Financial
- Net loss for the second quarter was $23.4 million, or ($0.28)
per share, compared to $31.9 million, or ($0.46) per share,
primarily due to recognition of a milestone payment for an upcoming
Japan NDA submission
- At June 30, 2018, FibroGen had $733.7 million of cash, cash
equivalents, investments, restricted time deposits, and
receivables
- The weighted average number of common shares used to calculate
net loss per share was 83.8 million shares and 69.6 million shares
for the second quarters of 2018 and 2017, respectively. Total
shares outstanding as of June 30, 2018 were 84.2 million
shares
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Tuesday,
August, 7, 2018, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)
to discuss financial results and provide a business update. A live
audio webcast of the call may be accessed in the investor section
of the company’s website, www.fibrogen.com. To participate in the
conference call by telephone, please dial 1 (888) 771-4371 (U.S.
and Canada) or 1 (847) 585-4405 (international), reference the
FibroGen second quarter 2018 financial results conference call, and
use passcode 47339190#. A replay of the webcast will be available
shortly after the call for a period of two weeks. To access the
replay, please dial 1 (888) 843-7419 (domestic) or 1 (630) 652-3042
(international), and use passcode 47339190#.
About Roxadustat Roxadustat (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.
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in
patients with CKD in territories including Japan, Europe, the
Commonwealth of Independent States, the Middle East, and South
Africa. AstraZeneca and FibroGen are collaborating on the
development and commercialization of roxadustat for the treatment
of anemia in patients with CKD in the U.S., China, and other
markets.
Roxadustat is advancing through Phase 3 clinical trials
worldwide, with multiple trials completed. The Phase 3 program is
supported by extensive Phase 2 clinical data demonstrating
correction and maintenance of hemoglobin levels in multiple
subpopulations of CKD anemia patients. Globally, the Phase 3
program encompasses a total of 15 Phase 3 studies to support
independent regulatory approvals of roxadustat in both
non-dialysis-dependent and dialysis-dependent CKD patients in the
U.S., Europe, Japan, and China. Roxadustat is currently in Phase 3
clinical development for the treatment of anemia associated with
myelodysplastic syndromes (MDS) in the U.S. and in Phase 2/3
development for MDS in China.
About Pamrevlumab Pamrevlumab is a
first-in-class antibody developed by FibroGen to inhibit the
activity of connective tissue growth factor (CTGF), a common factor
in fibrotic and proliferative disorders characterized by persistent
and excessive scarring that can lead to organ dysfunction and
failure. Pamrevlumab is advancing towards Phase 3 clinical
development for the treatment of idiopathic pulmonary fibrosis
(IPF) and pancreatic cancer and has been granted Orphan Drug
Designation (ODD) in each of these indications, and is currently in
a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab
has received Fast Track designation from the U.S. Food and Drug
Administration for the treatment of patients with locally advanced
unresectable pancreatic cancer. Across all trials, pamrevlumab has
consistently demonstrated a good safety and tolerability profile to
date. For information about pamrevlumab studies currently
recruiting patients, please visit www.clinicaltrials.gov.
About FibroGen FibroGen, Inc., headquartered in
San Francisco, with subsidiary offices in Beijing and Shanghai, is
a leading biopharmaceutical company discovering and developing a
pipeline of first-in-class therapeutics. The company applies
its pioneering expertise in hypoxia-inducible factor (HIF),
connective tissue growth factor (CTGF) 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, completing worldwide
Phase 3 clinical development for the treatment of anemia in chronic
kidney disease (CKD), with a New Drug Application (NDA) currently
under review in China by the State Drug Administration (SDA).
Roxadustat is in Phase 3 clinical development in the U.S. and
Europe and in Phase 2/3 development in China for anemia associated
with myelodysplastic syndromes (MDS). Pamrevlumab, an
anti-CTGF human monoclonal antibody, is advancing towards Phase 3
clinical development for the treatment of idiopathic pulmonary
fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2
trial for Duchenne muscular dystrophy (DMD). FibroGen is also
developing a biosynthetic cornea in China. For more information,
please visit www.fibrogen.com.
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,” “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 December 31, 2017, and our Quarterly Report on Form 10-Q for
the fiscal quarter ended June 30, 2018 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, 2018 |
|
|
December 31, 2017 (1) |
|
|
(Unaudited) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
643,803 |
|
|
$ |
673,658 |
|
Short-term investments |
|
28,094 |
|
|
|
62,060 |
|
Accounts
receivable |
|
30,189 |
|
|
|
8,452 |
|
Prepaid
expenses and other current assets |
|
17,997 |
|
|
|
4,800 |
|
Total
current assets |
|
720,083 |
|
|
|
748,970 |
|
|
|
|
|
|
|
|
|
Restricted time
deposits |
|
5,181 |
|
|
|
5,181 |
|
Long-term
investments |
|
10,587 |
|
|
|
10,506 |
|
Property and equipment,
net |
|
128,829 |
|
|
|
129,476 |
|
Other assets |
|
5,239 |
|
|
|
4,517 |
|
Total assets |
$ |
869,919 |
|
|
$ |
898,650 |
|
|
|
|
|
|
|
|
|
Liabilities,
stockholders’ equity and non-controlling interests |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
$ |
3,222 |
|
|
$ |
5,509 |
|
Accrued
liabilities |
|
49,492 |
|
|
|
63,781 |
|
Deferred
revenue |
|
37,845 |
|
|
|
16,670 |
|
Total
current liabilities |
|
90,559 |
|
|
|
85,960 |
|
|
|
|
|
|
|
|
|
Long-term portion of
lease financing obligations |
|
97,473 |
|
|
|
97,763 |
|
Product development
obligations |
|
16,981 |
|
|
|
17,244 |
|
Deferred rent |
|
3,350 |
|
|
|
3,657 |
|
Deferred revenue, net
of current |
|
137,436 |
|
|
|
138,241 |
|
Other long-term
liabilities |
|
9,318 |
|
|
|
8,047 |
|
Total
liabilities |
|
355,117 |
|
|
|
350,912 |
|
|
|
|
|
|
|
|
|
Total stockholders’
equity |
|
495,531 |
|
|
|
528,467 |
|
Non-controlling
interests |
|
19,271 |
|
|
|
19,271 |
|
Total equity |
|
514,802 |
|
|
|
547,738 |
|
Total
liabilities, stockholders’ equity and non-controlling
interests |
$ |
869,919 |
|
|
$ |
898,650 |
|
(1) The condensed consolidated balance
sheet amounts at December 31, 2017 are recast from audited
financial statements to reflect the adoption of the new revenue
standards as of January 1, 2018.
Condensed Consolidated Statements of
Operations(In thousands, except per share data)
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
2018 |
|
|
2017 (1) |
|
|
2018 |
|
|
2017 (1) |
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(1) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
revenue |
$ |
14,323 |
|
|
$ |
— |
|
|
$ |
14,323 |
|
|
$ |
- |
|
Development and other revenue |
|
29,629 |
|
|
|
30,268 |
|
|
|
61,553 |
|
|
|
59,710 |
|
Total
revenue |
|
43,952 |
|
|
|
30,268 |
|
|
|
75,876 |
|
|
|
59,710 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
52,138 |
|
|
|
46,981 |
|
|
|
109,112 |
|
|
|
93,713 |
|
General
and administrative |
|
15,055 |
|
|
|
13,425 |
|
|
|
30,605 |
|
|
|
24,955 |
|
Total
operating expenses |
|
67,193 |
|
|
|
60,406 |
|
|
|
139,717 |
|
|
|
118,668 |
|
Loss from
operations |
|
(23,241 |
) |
|
|
(30,138 |
) |
|
|
(63,841 |
) |
|
|
(58,958 |
) |
Interest and
other, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
(2,750 |
) |
|
|
(2,757 |
) |
|
|
(5,519 |
) |
|
|
(5,132 |
) |
Interest
income and other, net |
|
2,646 |
|
|
|
1,031 |
|
|
|
4,717 |
|
|
|
1,677 |
|
Total
interest and other, net |
|
(104 |
) |
|
|
(1,726 |
) |
|
|
(802 |
) |
|
|
(3,455 |
) |
Loss before
income taxes |
|
(23,345 |
) |
|
|
(31,864 |
) |
|
|
(64,643 |
) |
|
|
(62,413 |
) |
Provision for income
taxes |
|
75 |
|
|
|
48 |
|
|
|
174 |
|
|
|
109 |
|
Net
loss |
$ |
(23,420 |
) |
|
|
(31,912 |
) |
|
$ |
(64,817 |
) |
|
$ |
(62,522 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.28 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.94 |
) |
Weighted average number
of common shares used to calculate net loss per share - basic and
diluted |
|
83,750 |
|
|
|
69,638 |
|
|
|
83,309 |
|
|
|
66,853 |
|
(1) The condensed consolidated statements
of operations amounts for the three and six months ended June 30,
2017 are recast from unaudited financial statements to reflect the
adoption of the new revenue standards as of January 1, 2018.
ContactFibroGen, Inc.Karen L. BergmanVice
President, Investor Relations and Corporate Communications1 (415)
978-1433kbergman@fibrogen.com
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