FibroGen Reports Second Quarter 2020 Financial Results
August 06 2020 - 4:02PM
FibroGen, Inc. (NASDAQ:FGEN) reported financial results for the
second quarter of 2020 and provided an update on the company’s
recent developments.
“Despite this difficult time, we continue to be inspired by our
unique opportunity to leverage world-class science to benefit
patients,” said Enrique Conterno, Chief Executive
Officer, FibroGen. “I am pleased with the progress we are
making with roxadustat across a number of fronts; including our
engagement with the FDA, the European submission, and our
impressive sales in China. Additionally, we recently initiated
three new trials with pamrevlumab: our Phase 3 study with DMD and
two trials in patients hospitalized with COVID-19.”
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 dialysis-dependent and
non-dialysis-dependent patients, is under review with a
Prescription Drug User Fee Act (PDUFA) date of December 20,
2020.
- Marketing authorization application (MAA) for roxadustat for
the treatment of anemia in adult patients with CKD, both on
dialysis and not on dialysis, accepted by the European Medicines
Agency (EMA) for regulatory review in May.
- Japan sNDA for roxadustat for the treatment of anemia of CKD in
non-dialysis-dependent patients is under review.
- Presented results from the DOLOMITES Phase 3 study at the 57th
ERA-EDTA Virtual Congress in which roxadustat demonstrated
non-inferiority to darbepoetin alfa in achievement of hemoglobin
correction in non-dialysis-dependent patients with CKD.
- Continued enrollment of Phase 3 roxadustat clinical trial in
anemia associated with myelodysplastic syndromes (MDS) and Phase 2
roxadustat clinical trial in chemotherapy-induced anemia
(CIA).
Pamrevlumab
- Initiated a randomized, double-blind, placebo-controlled
Phase 2 study investigating the efficacy and safety of
pamrevlumab in approximately 130 hospitalized patients with acute
COVID-19 infection in the U.S.
- Initiated BOREA, a Phase 2/3 investigator-initiated clinical
trial investigating the efficacy and safety of pamrevlumab in
approximately 68 patients hospitalized with COVID-19 in Italy.
- Reopened enrollment of the ZEPHYRUS Phase 3 clinical trial of
pamrevlumab in patients with IPF after pausing for two months to
minimize the risk of exposure to COVID-19.
- Continued enrollment of the LAPIS Phase 3 clinical trial of
pamrevlumab in patients with locally advanced unresectable
pancreatic cancer (LAPC).
Upcoming Events
- Plan to initiate ZEPHYRUS 2, a second IPF Phase 3 clinical
trial similar in size and design to ZEPHYRUS, as COVID-19
conditions improve.
- Plan to initiate LELANTOS, a Phase 3, randomized, double-blind,
placebo-controlled trial of pamrevlumab in approximately 90
patients with non-ambulatory Duchenne muscular dystrophy
(DMD).
Corporate and Financial
- Total revenue for the second quarter of 2020 was $42.9 million,
as compared to $191.6 million for the second quarter of 2019. The
current quarter revenue consisted of $15.7 million in net
roxadustat sales in China, $19.0 million in development revenue,
and $8.2 million in roxadustat API sales to Astellas in Japan.
- Net loss for the second quarter of 2020 was $85.3 million, or
$0.95 net loss per basic and diluted share, compared to a net
income of $116.0 million, or $1.34 net income per basic share and
$1.26 per diluted share one year ago.
- At June 30, 2020, FibroGen had $716.0 million in cash, cash
equivalents, restricted time deposits, investments, and
receivables.
- Based on our latest forecast, we reiterate our year-end 2020
estimate to be in the range of $720 to $730 million in cash, cash
equivalents, restricted time deposits, investments, and
receivables.
- Amended China Agreement with AstraZeneca in July 2020 such that
both parties are optimally aligned to maximize the economic value
of the roxadustat franchise, with more predictable economics and
profitability for FibroGen.
- Appointed Thane Wettig to the newly-created position of Chief
Commercial Officer.
- Appointed Aoife Brennan, M.B., B.Ch., President and CEO of
Synlogic, Inc. (NASDAQ:SYBX) to board of directors effective August
5, 2020.
- Appointed Ben Cravatt, Ph.D., Professor and the Norton B.
Gilula Chair of Chemical Biology in the Department of Chemistry at
The Scripps Research Institute to board of directors effective
August 5, 2020.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Thursday,
August 6, 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 second quarter 2020 financial results conference call, and
use passcode 8363719. A replay of the webcast will be available
shortly after the call for a period of two weeks. To access the
replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and use passcode 8363719.
About Roxadustat Roxadustat is a
first-in-class, orally administered small molecule HIF-PH inhibitor
that promotes erythropoiesis through increasing endogenous
production of erythropoietin, and improved iron absorption,
transport and mobilization. Roxadustat is approved in China for the
treatment of anemia in adult patients with CKD, both on dialysis
and not on dialysis. In Japan it is approved for the treatment of
anemia in CKD patients on dialysis and a supplemental NDA for the
treatment of anemia in CKD patients not on dialysis is under
regulatory review. The roxadustat NDA for the treatment of anemia
in CKD is under review by the U.S. Food and Drug Administration
with a Prescription Drug User Fee Act date of December 20, 2020.
The Marketing Authorization Application for roxadustat for the
treatment of anemia in CKD was filed by our partner Astellas and
accepted by the European Medicines Agency for review on May 21,
2020. Roxadustat is also in clinical development for anemia
associated with myelodysplastic syndromes (MDS) and for
chemotherapy-induced anemia (CIA).
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in
territories including Japan and Europe. 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.
About Pamrevlumab Pamrevlumab is a
first-in-class antibody developed by FibroGen that inhibits the
activity of connective tissue growth factor (CTGF), a common factor
in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3
clinical development for the treatment of idiopathic pulmonary
fibrosis (IPF) and locally advanced unresectable pancreatic cancer
(LAPC), and in Phase 2 clinical development for the treatment of
Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19). For
information about pamrevlumab studies currently recruiting
patients, please visit www.clinicaltrials.gov.
About FibroGen FibroGen, Inc. is a
biopharmaceutical company committed to 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 to
advance innovative medicines to treat unmet needs. The Company is
currently developing and commercializing roxadustat, an oral small
molecule inhibitor of HIF prolyl hydroxylase activity, for anemia
associated with chronic kidney disease (CKD). Roxadustat is also in
clinical development for anemia associated with myelodysplastic
syndromes (MDS) and for chemotherapy-induced anemia (CIA).
Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical
development for the treatment of idiopathic pulmonary fibrosis
(IPF), locally advanced unresectable pancreatic cancer (LAPC),
Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). 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 and our Quarterly
Report on Form 10-Q for quarter ended June 30, 2020 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, 2020 |
|
|
December 31, 2019 |
|
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
429,269 |
|
|
$ |
126,266 |
|
|
Short-term investments |
|
256,317 |
|
|
|
407,491 |
|
|
Accounts receivable, net |
|
26,519 |
|
|
|
28,455 |
|
|
Inventory |
|
8,582 |
|
|
|
6,887 |
|
|
Prepaid expenses and other current assets |
|
6,481 |
|
|
|
133,391 |
|
|
Total current assets |
|
727,168 |
|
|
|
702,490 |
|
|
|
|
|
|
|
|
|
|
Restricted time deposits |
|
2,072 |
|
|
|
2,072 |
|
|
Long-term investments |
|
229 |
|
|
|
61,118 |
|
|
Property and equipment, net |
|
36,984 |
|
|
|
42,743 |
|
|
Finance lease right-of-use assets |
|
34,368 |
|
|
|
39,602 |
|
|
Other assets |
|
6,862 |
|
|
|
9,372 |
|
|
Total assets |
$ |
807,683 |
|
|
$ |
857,397 |
|
|
|
|
|
|
|
|
|
|
Liabilities, stockholders’ equity and non-controlling
interests |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
5,015 |
|
|
$ |
6,088 |
|
|
Accrued and other liabilities |
|
50,464 |
|
|
|
83,816 |
|
|
Deferred revenue |
|
9,813 |
|
|
|
490 |
|
|
Finance lease liabilities, current |
|
12,279 |
|
|
|
12,351 |
|
|
Total current liabilities |
|
77,571 |
|
|
|
102,745 |
|
|
|
|
|
|
|
|
|
|
Long-term portion of lease obligations |
|
940 |
|
|
|
1,141 |
|
|
Product development obligations |
|
16,959 |
|
|
|
16,780 |
|
|
Deferred revenue, net of current |
|
138,242 |
|
|
|
99,449 |
|
|
Finance lease liabilities, non-current |
|
31,586 |
|
|
|
37,610 |
|
|
Other long-term liabilities |
|
127,242 |
|
|
|
64,266 |
|
|
Total liabilities |
|
392,540 |
|
|
|
321,991 |
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
395,872 |
|
|
|
516,135 |
|
|
Non-controlling interests |
|
19,271 |
|
|
|
19,271 |
|
|
Total equity |
|
415,143 |
|
|
|
535,406 |
|
|
Total liabilities, stockholders’ equity and
non-controlling interests |
$ |
807,683 |
|
|
$ |
857,397 |
|
|
|
(1) The condensed consolidated balance sheet
amounts at December 31, 2019 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, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
— |
|
|
$ |
150,581 |
|
|
$ |
— |
|
|
$ |
150,581 |
|
Development and other revenue |
|
18,957 |
|
|
|
40,985 |
|
|
|
38,402 |
|
|
|
64,848 |
|
Product revenue, net |
|
15,693 |
|
|
|
— |
|
|
|
20,648 |
|
|
|
— |
|
Drug product revenue |
|
8,238 |
|
|
|
— |
|
|
|
8,238 |
|
|
|
— |
|
Total revenue |
|
42,888 |
|
|
|
191,566 |
|
|
|
67,288 |
|
|
|
215,429 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
3,076 |
|
|
|
— |
|
|
|
4,047 |
|
|
|
— |
|
Research and development |
|
61,414 |
|
|
|
52,008 |
|
|
|
116,315 |
|
|
|
102,505 |
|
Selling, general and administrative |
|
63,535 |
|
|
|
26,739 |
|
|
|
113,138 |
|
|
|
48,948 |
|
Total operating costs and expenses |
|
128,025 |
|
|
|
78,747 |
|
|
|
233,500 |
|
|
|
151,453 |
|
Income (loss) from operations |
|
(85,137 |
) |
|
|
112,819 |
|
|
|
(166,212 |
) |
|
|
63,976 |
|
Interest and other, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(651 |
) |
|
|
(736 |
) |
|
|
(1,284 |
) |
|
|
(1,507 |
) |
Interest income and other, net |
|
644 |
|
|
|
4,125 |
|
|
|
3,810 |
|
|
|
8,303 |
|
Total interest and other, net |
|
(7 |
) |
|
|
3,389 |
|
|
|
2,526 |
|
|
|
6,796 |
|
Income (loss) before income taxes |
|
(85,144 |
) |
|
|
116,208 |
|
|
|
(163,686 |
) |
|
|
70,772 |
|
Provision for (benefit from) income taxes |
|
169 |
|
|
|
205 |
|
|
|
(25 |
) |
|
|
180 |
|
Net income (loss) |
$ |
(85,313 |
) |
|
$ |
116,003 |
|
|
$ |
(163,661 |
) |
|
$ |
70,592 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.95 |
) |
|
$ |
1.34 |
|
|
$ |
(1.84 |
) |
|
$ |
0.82 |
|
Diluted |
$ |
(0.95 |
) |
|
$ |
1.26 |
|
|
$ |
(1.84 |
) |
|
$ |
0.77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used to calculate net
income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
89,451 |
|
|
|
86,445 |
|
|
|
88,835 |
|
|
|
86,077 |
|
Diluted |
|
89,451 |
|
|
|
91,728 |
|
|
|
88,835 |
|
|
|
92,069 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact: FibroGen, Inc.
Media Inquiries: Sara Iacovino
1.703.474.4452sara.iacovino@gcihealth.com
Investors: Michael Tung, M.D.Corporate Strategy / Investor
Relations1.415.978.1434mtung@fibrogen.com
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