FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for
the first quarter of 2020 and provided an update on the company’s
recent developments.
“During 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. “The COVID-19 pandemic has presented a
number of unprecedented challenges, including in the conduct and
enrollment of our clinical trials. Nevertheless, I want to reassure
patients, healthcare providers, and stakeholders of our continued
commitment to bring to patients our potential first-in-class
medicines for the treatment of chronic and life-threatening
conditions. Our strong financial position gives us sufficient
runway to navigate this storm.”
“We remain focused on ensuring the regulatory and commercial
success of roxadustat, a potentially transformational oral medicine
in anemia therapy, first demonstrated in patients with chronic
kidney disease. With pamrevlumab, our monoclonal antibody targeting
connective tissue growth factor (CTGF), we are implementing a
comprehensive plan to accelerate development across the three
indications of idiopathic pulmonary fibrosis (IPF), locally
advanced unresectable pancreatic cancer (LAPC), and Duchenne
muscular dystrophy (DMD) once the situation with COVID-19 improves.
Finally, we continue to advance the innovation of our
hypoxia-inducible factor (HIF) and CTGF platforms.”
Key Events in Recent Months and Other
Developments |
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Roxadustat |
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U.S. NDA for roxadustat for the treatment of anemia of chronic
kidney disease (CKD), in non-dialysis-dependent and
dialysis-dependent patients, is under review with a Prescription
Drug User Fee Act (PDUFA) date of December 20, 2020. |
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Japan sNDA for roxadustat for the treatment of anemia of chronic
kidney disease (CKD) in non-dialysis-dependent patients is under
review. |
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Presented new analyses from our Phase 3 roxadustat trials at the
annual National Kidney Foundation Spring Clinical meeting which
demonstrated: |
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Roxadustat corrected and maintained hemoglobin in non-dialysis
dependent patients with anemia using similar doses regardless of
iron status at baseline. |
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Roxadustat reduced the risk of red blood cell transfusions and IV
iron rescue compared to placebo in non-dialysis CKD patients,
regardless of iron status at baseline. |
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Roxadustat reduced the risk of red blood cell transfusion during
anemia treatment in dialysis dependent CKD patients vs. epoetin
alfa. |
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Pamrevlumab |
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To minimize the risk of exposure to COVID-19 in the vulnerable
patient population with compromised lung function from idiopathic
pulmonary fibrosis (IPF), paused near-term enrollment of ZEPHYRUS
Phase 3 clinical trial of pamrevlumab in patients with IPF. |
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Continue to enroll the LAPIS Phase 3 clinical trial of pamrevlumab
in patients with locally advanced unresectable pancreatic cancer
(LAPC). |
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Upcoming Events |
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In Europe, the Marketing Authorization Application filing for
roxadustat for the treatment of anemia in both dialysis- and
non-dialysis-dependent patients with CKD is expected in the second
quarter of 2020. |
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Plan to initiate ZEPHYRUS 2, a second IPF Phase 3 clinical trial
similar in size and design to ZEPHYRUS, as COVID-19 conditions
improve. |
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Plan to initiate LELANTOS, a Phase 3 global clinical trial of
pamrevlumab in DMD in the second half 2020. This trial will enroll
approximately 90 patients randomized 1:1 to placebo and have a
treatment period of 52 weeks. |
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Corporate and
Financial |
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Total revenue for the first quarter of 2020 was $24.4 million, as
compared to $23.9 million for the first quarter of 2019. The
current quarter revenue consisted of $19.4 million in development
revenue, and $5.0 million in net roxadustat sales in China. |
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Net loss for the first quarter of 2020 was $78.3 million, or $0.89
net loss per basic and diluted share, compared to a net income of
$45.4 million, or $0.53 net loss per basic and diluted share one
year ago. |
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At March 31, FibroGen had $598.4 million in cash, cash equivalents,
restricted time deposits, investments, and receivables. |
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Based on our latest forecast, we reiterate our year end 2020
estimate to be in the range of $720 million to $730 million in
cash, cash equivalents, restricted time deposits, investments, and
receivables. |
Conference Call and Webcast DetailsFibroGen
will host a conference call and webcast today, Thursday, May 7,
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 first quarter 2020 financial results conference call, and
use passcode 9946439. 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 9946439.
About RoxadustatRoxadustat 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 CKD patients on dialysis and patients not on dialysis,
and is approved in Japan 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. FDA with a Prescription Drug User Fee Act date
of December 20, 2020. Our partner Astellas expects the Marketing
Authorization Application filing for roxadustat for the treatment
of anemia in CKD in the second quarter of 2020. Roxadustat is also
in clinical development for anemia associated with myelodysplastic
syndromes (MDS) and for chemotherapy-induced anemia.
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). 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. Pamrevlumab,
an anti-CTGF human monoclonal antibody, is in clinical development
for the treatment of idiopathic pulmonary fibrosis (IPF), locally
advanced unresectable pancreatic cancer, and 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 and our Quarterly
Report on Form 10-Q for quarter ended March 31, 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.
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Condensed
Consolidated Balance Sheets (In thousands) |
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March 31, 2020 |
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December 31, 2019 |
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(Unaudited) |
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(1) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
121,560 |
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$ |
126,266 |
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Short-term investments |
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413,869 |
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407,491 |
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Accounts receivable, net |
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58,540 |
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28,455 |
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Inventory |
|
8,408 |
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|
6,887 |
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Prepaid expenses and other current assets |
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134,028 |
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133,391 |
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Total current assets |
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736,405 |
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702,490 |
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Restricted time deposits |
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2,072 |
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2,072 |
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Long-term investments |
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223 |
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61,118 |
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Property and equipment,
net |
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40,058 |
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42,743 |
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Finance lease right-of-use
assets |
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37,017 |
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39,602 |
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Other assets |
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8,602 |
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|
9,372 |
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Total assets |
$ |
824,377 |
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$ |
857,397 |
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Liabilities,
stockholders’ equity and non-controlling interests |
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Current liabilities: |
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Accounts payable |
$ |
2,865 |
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$ |
6,088 |
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Accrued and other liabilities |
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42,309 |
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83,816 |
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Deferred revenue |
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8,531 |
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|
490 |
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Finance lease liabilities, current |
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12,396 |
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|
12,351 |
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Total current liabilities |
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66,101 |
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102,745 |
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Long-term portion of lease obligations |
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1,040 |
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|
1,141 |
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Product development obligations |
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16,536 |
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16,780 |
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Deferred revenue, net of current |
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139,404 |
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99,449 |
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Finance lease liabilities, non-current |
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34,545 |
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37,610 |
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Other long-term liabilities |
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89,122 |
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64,266 |
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Total liabilities |
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346,748 |
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321,991 |
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Total stockholders’ equity |
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458,358 |
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516,135 |
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Non-controlling interests |
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19,271 |
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19,271 |
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Total equity |
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477,629 |
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535,406 |
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Total liabilities, stockholders’ equity and
non-controlling interests |
$ |
824,377 |
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$ |
857,397 |
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(1) The condensed consolidated
balance sheet amounts at December 31, 2019 are derived from
audited financial statements.
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Condensed
Consolidated Statements of Operations |
(In thousands,
except per share data) |
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Three Months Ended March 31, |
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2020 |
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2019 |
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(Unaudited) |
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Revenue: |
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License revenue |
$ |
— |
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$ |
— |
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Development and other revenue |
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19,446 |
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23,863 |
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Product revenue, net |
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4,955 |
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— |
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Total revenue |
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24,401 |
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|
|
23,863 |
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Operating costs and
expenses: |
|
|
|
|
|
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Cost of goods sold |
|
970 |
|
|
|
— |
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Research and development |
|
54,902 |
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|
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50,496 |
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Selling, general and administrative |
|
49,603 |
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|
|
22,210 |
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Total operating costs and expenses |
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105,475 |
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|
|
72,706 |
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Loss from
operations |
|
(81,074 |
) |
|
|
(48,843 |
) |
Interest and other,
net: |
|
|
|
|
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Interest expense |
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(633 |
) |
|
|
(770 |
) |
Interest income and other, net |
|
3,165 |
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|
|
4,177 |
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Total interest and other, net |
|
2,532 |
|
|
|
3,407 |
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Loss before income
taxes |
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(78,542 |
) |
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(45,436 |
) |
Benefit from income taxes |
|
(194 |
) |
|
|
(25 |
) |
Net loss |
$ |
(78,348 |
) |
|
$ |
(45,411 |
) |
|
|
|
|
|
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Net loss per share - basic and diluted |
$ |
(0.89 |
) |
|
$ |
(0.53 |
) |
|
|
|
|
|
|
|
|
Weighted average number of common shares used to calculate net
loss per share - basic and diluted |
|
88,219 |
|
|
|
85,704 |
|
(1) The condensed consolidated
statement of operations amounts for the year ended
December 31, 2019 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.Corporate Strategy / Investor
Relations1.415.978.1434mtung@fibrogen.com
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