FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for
the fourth quarter and full year of 2019 and provided an update on
the company’s recent developments.
“I am thrilled to be joining FibroGen at such an important
inflection point for the company. In 2019 we submitted the
roxadustat U.S. New Drug Application (NDA), launched roxadustat in
China and Japan, and initiated pivotal programs for pamrevlumab in
idiopathic pulmonary fibrosis (IPF) and locally advanced
unresectable pancreatic cancer (LAPC),” said Enrique Conterno,
Chief Executive Officer, FibroGen. “We begin 2020 with a strong
foundation on which to build and with continued commitment to
unlocking new treatment options that improve patients’ lives.
"FibroGen has a unique opportunity to leverage its world class
science in three areas of focus: ensuring the regulatory and
commercial success of roxadustat – a potentially transformational
oral medicine in anemia therapy, first demonstrated in patients
with chronic kidney disease; accelerating the development of
pamrevlumab, in the three high-value indications of IPF, LAPC, and
Duchenne muscular dystrophy (DMD); and advancing innovation of our
hypoxia-inducible factor (HIF) and connective tissue growth factor
(CTGF) platforms.”
Key Events in Recent Months and Other
Developments
Roxadustat
- U.S. NDA for roxadustat for the treatment of anemia of chronic
kidney disease (CKD), in non-dialysis-dependent and
dialysis-dependent patients, accepted with a Prescription Drug User
Fee Act (PDUFA) date of December 20, 2020.
- Received expanded approval of roxadustat (China tradename:
爱瑞卓®) in China for the treatment of anemia in CKD patients who are
not dialysis-dependent.
- Achieved roxadustat inclusion in the China National
Reimbursement Drug List.
- In Japan, partner Astellas received approval of and launched
roxadustat (Japan trade name Evrenzo®) in anemia in
dialysis-dependent CKD patients, and submitted the supplemental NDA
for the non-dialysis indication this past January.
- Results from the open-label portion of our Phase 3 study of
roxadustat for treatment of anemia in patients with myelodysplastic
syndromes (MDS) presented at the 2019 American Society of
Hematology Annual Meeting. The randomized placebo-controlled,
double-blind portion of this global Phase 3 study is
ongoing.
- Initiated Phase 2 open-label study of roxadustat for
chemotherapy-induced anemia (CIA).
Pamrevlumab
- Initiated the ZEPHYRUS Phase 3 clinical study of pamrevlumab in
patients with idiopathic pulmonary fibrosis (IPF).
- In 2020, we will initiate ZEPHYRUS 2, a second IPF Phase 3
study similar in design to ZEPHYRUS.
- We plan to enroll approximately 340 patients in each
study.
- Initiated the LAPIS Phase 3 clinical trial of pamrevlumab
for the treatment of patients with locally advanced unresectable
pancreatic cancer (LAPC).
Upcoming Events
- In Europe, partner Astellas expects to submit Marketing
Authorization Application (MAA) for roxadustat for treatment of
dialysis- and non-dialysis-dependent CKD anemia in the second
quarter of 2020.
- Plan to initiate a pamrevlumab Phase 3 study in DMD in the
second half 2020.
Corporate and Financial
- Net loss for the fourth quarter of 2019 was $98.1 million, or
$1.12 net loss per basic and diluted share, compared to a net
income of $21.0 million, or $0.25 net income per basic share and
$0.23 net income per diluted share one year ago.
- Net loss for the year was $77.0 million, or $0.89 net loss per
basic and diluted share, compared to a net loss of $86.4 million,
or $1.03 net loss per basic and diluted share one year ago.
- At December 31, 2019, FibroGen had $627.1 million in cash,
restricted time deposits, cash equivalents, investments, and
receivables.
- Based on our latest forecast, we estimate our 2020 ending cash
to be in the range of $720 million to $730 million.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday,
March 2, 2020, 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 (877) 658-9081 (U.S.
and Canada) or 1 (602) 563-8732 (international), reference the
FibroGen fourth quarter 2019 financial results conference call, and
use confirmation number 8058848. A replay of the
webcast will be available shortly after the call for a period of
four weeks. To access the replay, please dial 1 (855) 859-2056
(domestic) or 1 (404) 537-3406 (international), and use passcode
8058848.
About Roxadustat
Roxadustat is a first-in-class, orally administered small
molecule HIF-PH inhibitor that promotes erythropoiesis through
increasing endogenous production of erythropoietin, improving iron
regulation, and overcoming the negative impact of inflammation on
hemoglobin synthesis and red blood cell production by
downregulating 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 chronic
kidney disease (CKD) patients, including in the presence of
inflammation and without a need for supplemental intravenous iron.
Roxadustat is currently approved in China for the treatment of
anemia in CKD patients on dialysis and patients not on dialysis and
approved in Japan for the treatment of anemia in CKD patients on
dialysis. The NDA filing for roxadustat for the treatment of CKD
anemia was accepted by the U.S. Food and Drug Administration in
February 2020. Astellas is in the process of preparing an MAA for
submission to the European Medicines Agency in the second quarter
of 2020. 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), and in a Phase 2
U.S. trial for treatment of chemotherapy-induced anemia.
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia 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 the
U.S., China, and other markets in the Americas and in Australia/New
Zealand as well as Southeast Asia.
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 in Phase 3
clinical development for the treatment of idiopathic pulmonary
fibrosis (IPF) and for the treatment of locally advanced
unresectable pancreatic cancer (LAPC), and in Phase 2 clinical
development for the treatment of Duchenne muscular dystrophy (DMD).
The U.S. Food and Drug Administration has granted Orphan Drug
Designation to pamrevlumab for the treatment of patients with IPF,
LAPC, and DMD. Pamrevlumab has also received Fast Track designation
from the U.S. Food and Drug Administration for the treatment of
patients with IPF and LAPC. Across all clinical studies,
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, California, with
subsidiary offices in Beijing and Shanghai, People’s Republic of
China, is a leading biopharmaceutical company discovering,
developing and commercializing a pipeline of first-in-class
therapeutics. The company applies its pioneering expertise in
hypoxia-inducible factor (HIF) and 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, an oral
small molecule inhibitor of HIF prolyl hydroxylase activity, is
approved by the National Medical Products Administration in China
for CKD patients on dialysis and not on dialysis and by the
Ministry of Health, Labour and Welfare in Japan for CKD patients on
dialysis. The NDA filing for roxadustat for the treatment of CKD
anemia was accepted by the U.S. Food and Drug Administration in
February 2020. Astellas is in the process of preparing an MAA for
submission to the European Medicines Agency in the second quarter
of 2020. 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), and in a Phase 2
U.S. trial for treatment of chemotherapy-induced anemia.
Pamrevlumab, an anti-CTGF human monoclonal antibody, is in 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). 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 and commercialization of the company’s
product candidates, our financial results, the potential safety and
efficacy profile of our product candidates, our clinical programs
and regulatory events, 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, 2019 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)
|
December 31,
2019 |
|
|
December 31,
2018 |
|
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
126,266 |
|
|
$ |
89,258 |
|
|
Short-term investments |
|
407,491 |
|
|
|
532,144 |
|
|
Accounts receivable, net |
|
28,455 |
|
|
|
63,684 |
|
|
Inventory |
|
6,887 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
|
133,391 |
|
|
|
4,929 |
|
|
Total current assets |
|
702,490 |
|
|
|
690,015 |
|
|
|
|
|
|
|
|
|
|
Restricted time deposits |
|
2,072 |
|
|
|
4,145 |
|
|
Long-term investments |
|
61,118 |
|
|
|
55,820 |
|
|
Property and equipment, net |
|
42,743 |
|
|
|
127,198 |
|
|
Finance lease right-of-use assets |
|
39,602 |
|
|
|
— |
|
|
Other assets |
|
9,372 |
|
|
|
3,420 |
|
|
Total assets |
$ |
857,397 |
|
|
$ |
880,598 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities, stockholders’
equity and non-controlling interests |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
6,088 |
|
|
$ |
9,139 |
|
|
Accrued and other liabilities |
|
83,816 |
|
|
|
66,123 |
|
|
Deferred revenue |
|
490 |
|
|
|
13,771 |
|
|
Finance lease liabilities, current |
|
12,351 |
|
|
|
— |
|
|
Total current liabilities |
|
102,745 |
|
|
|
89,033 |
|
|
|
|
|
|
|
|
|
|
Long-term portion of lease obligations |
|
1,141 |
|
|
|
97,157 |
|
|
Product development obligations |
|
16,780 |
|
|
|
16,798 |
|
|
Deferred rent |
|
— |
|
|
|
3,038 |
|
|
Deferred revenue, net of current |
|
99,449 |
|
|
|
136,109 |
|
|
Finance lease liabilities, non-current |
|
37,610 |
|
|
|
— |
|
|
Other long-term liabilities |
|
64,266 |
|
|
|
9,993 |
|
|
Total liabilities |
|
321,991 |
|
|
|
352,128 |
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
516,135 |
|
|
|
509,199 |
|
|
Non-controlling interests |
|
19,271 |
|
|
|
19,271 |
|
|
Total equity |
|
535,406 |
|
|
|
528,470 |
|
|
Total liabilities,
stockholders’ equity and
non-controlling interests |
$ |
857,397 |
|
|
$ |
880,598 |
|
|
(1) The condensed consolidated
balance sheet amounts at December 31, 2018 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, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(1) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
14,569 |
|
|
$ |
7,947 |
|
|
$ |
177,086 |
|
|
$ |
22,269 |
|
Development and other revenue |
|
28,607 |
|
|
|
35,331 |
|
|
|
114,115 |
|
|
|
125,913 |
|
Product revenue, net |
|
(35,202 |
) |
|
|
64,776 |
|
|
|
(34,624 |
) |
|
|
64,776 |
|
Total revenue |
|
7,974 |
|
|
|
108,054 |
|
|
|
256,577 |
|
|
|
212,958 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
905 |
|
|
|
— |
|
|
|
1,147 |
|
|
|
— |
|
Research and development |
|
56,797 |
|
|
|
70,284 |
|
|
|
209,265 |
|
|
|
235,839 |
|
Selling, general and administrative |
|
50,708 |
|
|
|
17,851 |
|
|
|
135,479 |
|
|
|
63,812 |
|
Total operating costs and expenses |
|
108,410 |
|
|
|
88,135 |
|
|
|
345,891 |
|
|
|
299,651 |
|
Income (loss) from operations |
|
(100,436 |
) |
|
|
19,919 |
|
|
|
(89,314 |
) |
|
|
(86,693 |
) |
Interest and other, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(668 |
) |
|
|
(2,734 |
) |
|
|
(2,876 |
) |
|
|
(10,991 |
) |
Interest income and other, net |
|
3,053 |
|
|
|
3,772 |
|
|
|
15,548 |
|
|
|
11,568 |
|
Total interest and other, net |
|
2,385 |
|
|
|
1,038 |
|
|
|
12,672 |
|
|
|
577 |
|
Income (loss) before income taxes |
|
(98,051 |
) |
|
|
20,957 |
|
|
|
(76,642 |
) |
|
|
(86,116 |
) |
Provision for income taxes |
|
72 |
|
|
|
5 |
|
|
|
328 |
|
|
|
304 |
|
Net income (loss) |
$ |
(98,123 |
) |
|
$ |
20,952 |
|
|
$ |
(76,970 |
) |
|
$ |
(86,420 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(1.12 |
) |
|
$ |
0.25 |
|
|
$ |
(0.89 |
) |
|
$ |
(1.03 |
) |
Diluted |
$ |
(1.12 |
) |
|
$ |
0.23 |
|
|
$ |
(0.89 |
) |
|
$ |
(1.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used to calculate net
income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
87,352 |
|
|
|
85,096 |
|
|
|
86,633 |
|
|
|
84,062 |
|
Diluted |
|
87,352 |
|
|
|
91,260 |
|
|
|
86,633 |
|
|
|
84,062 |
|
(1) The condensed consolidated
statement of operations amounts for the year ended
December 31, 2018 are derived from audited financial
statements.
Contact:FibroGen, Inc.
Media Inquiries: Sara Iacovino
1.703.474.4452sara.iacovino@gcihealth.com
Investors: Michael Tung, M.D.Investor
Relations1.415.978.1433ir@fibrogen.com
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