FibroGen, Inc. (NASDAQ:FGEN) reported financial results for the
third quarter of 2020 and provided an update on the company’s
recent developments.
“I am pleased with our progress with roxadustat across a number
of fronts; including engagement with the FDA, commercial
preparations in the U.S., and our impressive sales results in
China.” said Enrique Conterno, Chief Executive Officer, FibroGen.
“As the world navigates the effects of the COVID-19 pandemic, we
continue to advance our roxadustat and pamrevlumab clinical
programs.”
Key Events in Recent Months and Other
Developments
Roxadustat
- FibroGen and its partners presented 42 abstracts, including 10
oral presentations and 2 late-breaker poster presentations, at the
recent American Society of Nephrology (ASN) Kidney Week 2020
Reimagined conference: • Two late-breaking abstracts explored
the cardiovascular outcomes of patients with anemia of chronic
kidney disease (CKD) treated with roxadustat, including
associations between achieved hemoglobin levels and risk of Major
Adverse Cardiovascular Events (MACE) and MACE+. • New
analyses showed the efficacy of roxadustat across the continuum of
patients with anemia of CKD – both on dialysis and not on dialysis
– including different dialysis modalities, iron repletion status,
and comorbidities. • Presentations addressed the safety
profile of roxadustat related to neoplasms, hypertension, and
ophthalmological effects. • Additional presentations explored
the increased risk of red blood cell transfusion at lower
hemoglobin levels and the impact of roxadustat on rates of
hospitalization due to heart failure.
- U.S. NDA for roxadustat for the treatment of anemia of chronic
kidney disease, 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, is under review by the European
Medicines Agency (EMA).
- Japan sNDA for roxadustat for the treatment of anemia of CKD in
non-dialysis-dependent patients is under review by the
Pharmaceuticals and Medical Devices Agency (PMDA).
- Continued enrollment of the 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 LELANTOS, a Phase 3 trial of pamrevlumab in patients
with non-ambulatory Duchenne muscular dystrophy (DMD).
- Continued enrollment of the ZEPHYRUS Phase 3 clinical trial of
pamrevlumab in patients with idiopathic pulmonary fibrosis
(IPF).
- 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 Phase 3 trial of pamrevlumab in
patients with idiopathic pulmonary fibrosis (IPF) as COVID-19
conditions improve.
- Plan to initiate LELANTOS-2, a Phase 3 trial of pamrevlumab in
patients with ambulatory Duchenne muscular dystrophy (DMD) by
year-end.
Corporate and Financial
- Total revenue for the third quarter of
2020 was $44.0 million, as compared to $33.2 million for the third
quarter of 2019. The current quarter revenue consisted of $22.7
million in net roxadustat sales in China, $20.7 million in
development revenue, $2.3 million for sales of bulk drug product,
and a net reduction of $1.7 million for certain adjustments.
- Net income for the third quarter of
2020 was $33.0 million, or $0.36 net income per basic and $0.35 per
diluted share, compared to a net loss of $49.4 million, or $0.57
net loss per basic and diluted share one year ago.
- 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. As
a result, we reversed approximately $84.4 million of co-promotion
expenses as a reduction to selling, general and administrative
expenses in the third quarter of 2020.
- At September 30, 2020, FibroGen had
$719.3 million in cash, cash equivalents, restricted time deposits,
investments, and receivables.
- Based on our latest forecast, we now estimate our year-end 2020
balance for cash, cash equivalents, restricted time deposits,
investments, and receivables to be in the range of $770 to $780
million.
- Appointed Percy
Carter, MBA, PhD, to the newly-created position of Chief Scientific
Officer.
Conference Call and Webcast Details FibroGen
will host a conference call and webcast today, Thursday, November
5, 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 third quarter 2020 financial results conference call, and
use passcode 5994243. 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 5994243.
About RoxadustatRoxadustat is a first-in-class,
oral small molecule HIF-PH inhibitor that promotes erythropoiesis
through increased endogenous production of erythropoietin; improved
iron absorption, transport, and mobilization; and downregulation of
hepcidin, which helps to overcome the negative impact of
inflammation on hemoglobin synthesis and red blood cell production.
Roxadustat is approved in China for the treatment of anemia of
adult patients with CKD, both on dialysis and not on dialysis. In
Japan, roxadustat is approved for the treatment of anemia of CKD
patients on dialysis, and a supplemental NDA for the treatment of
anemia of CKD patients not on dialysis is under regulatory review.
The roxadustat NDA for the treatment of anemia of CKD in patients
both on dialysis and not on dialysis 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 of CKD in patients both
on dialysis and not on dialysis 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
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, 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 PamrevlumabPamrevlumab 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 Duchenne muscular dystrophy (DMD); and in Phase 2
clinical development for the treatment of coronavirus (COVID-19).
For information about pamrevlumab studies currently recruiting
patients, please visit www.clinicaltrials.gov.
About FibroGenFibroGen, 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 for the treatment of 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 September 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)
|
September 30, 2020 |
|
|
December 31, 2019 |
|
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
532,468 |
|
|
$ |
126,266 |
|
|
Short-term investments |
|
155,398 |
|
|
|
407,491 |
|
|
Accounts receivable, net |
|
26,252 |
|
|
|
28,455 |
|
|
Inventory |
|
11,803 |
|
|
|
6,887 |
|
|
Prepaid expenses and other current assets |
|
11,563 |
|
|
|
133,391 |
|
|
Total current assets |
|
737,484 |
|
|
|
702,490 |
|
|
|
|
|
|
|
|
|
|
Restricted time deposits |
|
2,072 |
|
|
|
2,072 |
|
|
Long-term investments |
|
247 |
|
|
|
61,118 |
|
|
Property and equipment,
net |
|
36,153 |
|
|
|
42,743 |
|
|
Finance lease right-of-use
assets |
|
32,028 |
|
|
|
39,602 |
|
|
Other assets |
|
4,031 |
|
|
|
9,372 |
|
|
Total assets |
$ |
812,015 |
|
|
$ |
857,397 |
|
|
|
|
|
|
|
|
|
|
Liabilities,
stockholders’ equity and non-controlling interests |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
7,553 |
|
|
$ |
6,088 |
|
|
Accrued and other liabilities |
|
90,572 |
|
|
|
83,816 |
|
|
Deferred revenue |
|
7,912 |
|
|
|
490 |
|
|
Finance lease liabilities, current |
|
12,311 |
|
|
|
12,351 |
|
|
Total current liabilities |
|
118,348 |
|
|
|
102,745 |
|
|
|
|
|
|
|
|
|
|
Long-term portion of lease
obligations |
|
839 |
|
|
|
1,141 |
|
|
Product development
obligations |
|
17,790 |
|
|
|
16,780 |
|
|
Deferred revenue, net of
current |
|
137,954 |
|
|
|
99,449 |
|
|
Finance lease liabilities,
non-current |
|
28,514 |
|
|
|
37,610 |
|
|
Other long-term
liabilities |
|
37,639 |
|
|
|
64,266 |
|
|
Total liabilities |
|
341,084 |
|
|
|
321,991 |
|
|
|
|
|
|
|
|
|
|
Total stockholders’
equity |
|
451,660 |
|
|
|
516,135 |
|
|
Non-controlling interests |
|
19,271 |
|
|
|
19,271 |
|
|
Total equity |
|
470,931 |
|
|
|
535,406 |
|
|
Total liabilities,
stockholders’ equity and non-controlling interests |
$ |
812,015 |
|
|
$ |
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
— |
|
|
$ |
11,935 |
|
|
$ |
— |
|
|
$ |
162,517 |
|
Development and other revenue |
|
20,663 |
|
|
|
20,660 |
|
|
|
59,065 |
|
|
|
85,507 |
|
Product revenue, net |
|
22,683 |
|
|
|
579 |
|
|
|
43,331 |
|
|
|
579 |
|
Drug product revenue |
|
686 |
|
|
|
— |
|
|
|
8,924 |
|
|
|
— |
|
Total revenue |
|
44,032 |
|
|
|
33,174 |
|
|
|
111,320 |
|
|
|
248,603 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
2,207 |
|
|
|
242 |
|
|
|
6,253 |
|
|
|
242 |
|
Research and development |
|
58,476 |
|
|
|
49,963 |
|
|
|
174,792 |
|
|
|
152,467 |
|
Selling, general and administrative |
|
(48,981 |
) |
|
|
35,823 |
|
|
|
64,157 |
|
|
|
84,772 |
|
Total operating costs and expenses |
|
11,702 |
|
|
|
86,028 |
|
|
|
245,202 |
|
|
|
237,481 |
|
Income (loss) from
operations |
|
32,330 |
|
|
|
(52,854 |
) |
|
|
(133,882 |
) |
|
|
11,122 |
|
Interest and other,
net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(580 |
) |
|
|
(702 |
) |
|
|
(1,864 |
) |
|
|
(2,209 |
) |
Interest income and other, net |
|
1,469 |
|
|
|
4,193 |
|
|
|
5,279 |
|
|
|
12,496 |
|
Total interest and other, net |
|
889 |
|
|
|
3,491 |
|
|
|
3,415 |
|
|
|
10,287 |
|
Income (loss) before
income taxes |
|
33,219 |
|
|
|
(49,363 |
) |
|
|
(130,467 |
) |
|
|
21,409 |
|
Provision for income
taxes |
|
215 |
|
|
|
76 |
|
|
|
190 |
|
|
|
256 |
|
Net income
(loss) |
$ |
33,004 |
|
|
$ |
(49,439 |
) |
|
$ |
(130,657 |
) |
|
$ |
21,153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.36 |
|
|
$ |
(0.57 |
) |
|
$ |
(1.46 |
) |
|
$ |
0.24 |
|
Diluted |
$ |
0.35 |
|
|
$ |
(0.57 |
) |
|
$ |
(1.46 |
) |
|
$ |
0.23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares usedto calculate net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
90,558 |
|
|
|
87,007 |
|
|
|
89,414 |
|
|
|
86,390 |
|
Diluted |
|
93,678 |
|
|
|
87,007 |
|
|
|
89,414 |
|
|
|
91,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts: FibroGen, Inc.
Investors:Michael Tung, MDCorporate Strategy /
Investor Relations+1.415.978.1434mtung@fibrogen.com
Media Inquiries:Jennifer
Harrington+1.610.574.9196jennifer.harrington@gcihealth.com
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