FibroGen Reports First Quarter 2024 Financial Results
2024年5月7日 - 5:02AM
FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for
the first quarter 2024 and provided an update on the company’s
recent developments.
“We are off to a strong start in 2024 marked by the
recent release of compelling Phase 1 data on FG-3246, our CD46
targeted antibody drug conjugate, in metastatic
castration-resistant prostate cancer and continued robust growth of
our roxadustat business in China,” said Thane Wettig, Chief
Executive Officer, FibroGen. “Looking ahead, we expect to report
topline data from our two late-stage clinical trials of pamrevlumab
in pancreatic cancer in the coming months. In addition, we have a
strong balance sheet and reaffirm our cash runway into 2026.”
Upcoming Milestones:
Pamrevlumab
- Topline data from the PanCAN Precision PromiseSM Phase 2/3
study of pamrevlumab in metastatic pancreatic cancer expected in
mid-2024, reflecting PanCAN’s updated timing to complete database
lock and subsequent analysis of the topline results by the
independent Statistical Monitoring Committee.
- Topline data from the LAPIS Phase 3 study of pamrevlumab in
locally advanced unresectable pancreatic cancer (LAPC) expected in
3Q 2024, due to the current trend in reported blinded overall
survival events needed to complete the study.
Roxadustat
- Expect approval decision for roxadustat in chemotherapy-induced
anemia (CIA) in China in the second half of 2024. If approved,
FibroGen will receive a $10 million milestone payment from
AstraZeneca.
Oncology Pipeline
- Initial data from Phase 1 investigator-initiated combination
study of FG-3246 with enzalutamide in metastatic
castration-resistant prostate cancer (mCRPC) to be presented at
ASCO 2024.
- Anticipate initiation of Phase 2 monotherapy dose optimization
study of FG-3246 in mCRPC in 2H 2024.
- Anticipate filing of an IND for FG-3175 (anti-CCR8 mAb) in
2025.
Recent Developments:
Oncology Pipeline
- Additional data from a total of 56 biomarker unselected and
heavily pre-treated patients in a Phase 1 monotherapy study of
FG-3246 in mCRPC reported.
- Efficacy analysis (includes adenocarcinoma patients receiving
doses ≥ 1.2 mg/kg):
- The median radiographic progression free survival (rPFS) in
this patient population was 8.7 months.
- For RECIST evaluable patients, 20% met the criteria of a
partial response, or measurable tumor reduction in size of ≥ 30%,
with a median duration of response of 7.5 months.
- PSA reductions of ≥ 50% were observed in 36% of PSA evaluable
patients.
- Safety analysis:
- The most frequent adverse events were consistent with other
MMAE-based antibody drug conjugates and included infusion-related
reactions, fatigue, weight loss, neutropenia, and peripheral
neuropathy.
- IND submitted for FG-3165 (Galectin-9 targeting mAb) for solid
tumors in April 2024.
Corporate
- Appointed Deyaa Adib, MD as Chief Medical Officer.
China:
- First quarter FibroGen net product revenue under U.S. GAAP from
the sale of roxadustat in China was $30.5 million compared to $24.2
million in the first quarter of 2023, an increase of 26% year over
year.
- First quarter total roxadustat net sales in China1 by FibroGen
and the distribution entity jointly owned by FibroGen and
AstraZeneca (JDE) was $79.4 million, compared to $64.1 million in
the first quarter of 2023, an increase of 24% year over year,
driven by a 39% increase in volume.
- Roxadustat continues to be the number one brand based on value
share in the anemia of CKD market in China.
- For 2024, we reiterate FibroGen’s full year net product revenue
under U.S. GAAP to range between $120 million to $135 million,
representing full year roxadustat net sales in China1 by FibroGen
and the JDE to range between $300 million to $340 million.
Financial:
- Total revenue for the first quarter of 2024 was $55.9 million,
as compared to $36.2 million for the first quarter of 2023, an
increase of 55% year over year. Total revenue increase was driven
by net product revenue in China and one-time drug product revenue
of $25.7 million recognized due to the termination of US/RoW
AstraZeneca agreement.
- Net loss for the first quarter of 2024 was $32.9 million, or
$0.33 net loss per basic and diluted share, compared to a net loss
of $76.7 million, or $0.81 net loss per basic and diluted share one
year ago.
- At March 31, 2024, FibroGen reported $214.7 million in cash -
defined as cash, cash equivalents, investments, and accounts
receivable.
- We expect our cash, cash equivalents, investments, and accounts
receivable to be sufficient to fund our operating plans into
2026.
Conference Call and Webcast
Details FibroGen will host a conference call and webcast
today, Monday, May 6, 2024, at 5:00 PM Eastern Time to discuss
financial results and provide a business update. Interested parties
may access a live audio webcast of the conference call via the
“Investor Relations” page of the Company’s website at
www.fibrogen.com. To access the call by phone, please go to this
link (registration link), and you will be provided with dial in
details. To avoid delays, we encourage participants to dial into
the conference call fifteen minutes ahead of the scheduled start
time. A replay of the webcast will also be available for a limited
time at the following link (webcast replay).
About PamrevlumabPamrevlumab is a
potential first-in-class antibody being developed by FibroGen to
inhibit the activity of connective tissue growth factor (CTGF).
Pamrevlumab is in Phase 3 clinical development for the treatment of
locally advanced unresectable pancreatic cancer (LAPC) and in Phase
2/3 for the treatment of metastatic pancreatic cancer. The U.S.
Food and Drug Administration has granted Orphan Drug Designation,
and Fast Track designation to pamrevlumab for the treatment of
patients with LAPC. Pamrevlumab has demonstrated a safety and
tolerability profile that has supported ongoing clinical
investigation in LAPC and metastatic pancreatic cancer. Pamrevlumab
is an investigational drug and not approved for marketing by any
regulatory authority. For information about our pamrevlumab studies
please visit www.clinicaltrials.gov.
About RoxadustatRoxadustat, an
oral medication, is the first in a new class of medicines
comprising HIF-PH inhibitors that promote erythropoiesis, or red
blood cell production, through increased endogenous production of
erythropoietin, improved iron absorption and mobilization, and
downregulation of hepcidin. Roxadustat is in clinical development
for chemotherapy-induced anemia (CIA) and a Supplemental New Drug
Application (sNDA) has been accepted by the China Health
Authority.
Roxadustat is approved in China, Europe, Japan, and
numerous other countries for the treatment of anemia of CKD in
adult patients on dialysis (DD) and not on dialysis (NDD). Several
other licensing applications for roxadustat have been submitted by
partners, Astellas and AstraZeneca, to regulatory authorities
across the globe, and are currently under review. Astellas and
FibroGen are collaborating on the development and commercialization
of roxadustat for the potential treatment of anemia in territories
including Japan, Europe, Turkey, Russia, and the Commonwealth of
Independent States, the Middle East, and South Africa. AstraZeneca
and FibroGen continue to collaborate on the development and
commercialization of roxadustat in China.
About FibroGen FibroGen, Inc. is a
biopharmaceutical company focused on accelerating the development
of novel therapies at the frontiers of cancer biology. Pamrevlumab,
a fully human anti-CTGF monoclonal antibody, is in clinical
development for the treatment of metastatic pancreatic cancer and
locally advanced unresectable pancreatic cancer (LAPC). Roxadustat
(爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and
numerous other countries for the treatment of anemia in chronic
kidney disease (CKD) patients on dialysis and not on dialysis.
Roxadustat is in clinical development for chemotherapy-induced
anemia (CIA) and a Supplemental New Drug Application (sNDA) has
been accepted for review by the China Health Authority. FG-3246
(also known as FOR46), a first-in-class antibody-drug conjugate
(ADC) targeting CD46 is in development for the treatment of
metastatic castration-resistant prostate cancer. This program also
includes the development of an associated CD46-targeted PET
biomarker. In addition, FibroGen has expanded its research and
development portfolio to include two immuno-oncology product
candidates for the treatment of solid tumors. For more information,
please visit www.fibrogen.com.
Forward-Looking Statements This
release contains forward-looking statements regarding FibroGen’s
strategy, future plans and prospects, including statements
regarding its clinical programs and those of its collaboration
partners Fortis, UCSF, and the Pancreatic Cancer Action Network.
These forward-looking statements include, but are not limited to,
statements regarding the efficacy, safety, and potential success of
FibroGen product candidates, and statements about FibroGen’s plans
and objectives 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. FibroGen’s 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 its various programs, including the
enrollment and results from ongoing and potential future clinical
trials, and other matters that are described in FibroGen’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2023, as
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 FibroGen undertakes
no obligation to update any forward-looking statement in this press
release, except as required by law.
___________________1 Total roxadustat net sales in
China includes sales made by the distribution entity as well as
FibroGen China’s direct sales, each to its own distributors. The
distribution entity jointly owned by AstraZeneca and FibroGen is
not consolidated into FibroGen’s financial statements.
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Condensed
Consolidated Balance Sheets(In thousands) |
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March 31, 2024 |
|
|
December 31, 2023 |
|
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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 |
$ |
105,734 |
|
|
$ |
113,688 |
|
Short-term investments |
|
71,865 |
|
|
|
121,898 |
|
Accounts receivable, net |
|
37,083 |
|
|
|
12,553 |
|
Inventory |
|
27,335 |
|
|
|
41,565 |
|
Prepaid expenses and other current assets |
|
36,150 |
|
|
|
41,855 |
|
Total current assets |
|
278,167 |
|
|
|
331,559 |
|
|
|
|
|
|
|
Restricted time deposits |
|
1,658 |
|
|
|
1,658 |
|
Property and equipment,
net |
|
12,166 |
|
|
|
13,126 |
|
Equity method investment in
unconsolidated variable interest entity |
|
5,776 |
|
|
|
5,290 |
|
Operating lease right-of-use
assets |
|
64,751 |
|
|
|
68,093 |
|
Other assets |
|
3,350 |
|
|
|
3,803 |
|
Total assets |
$ |
365,868 |
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$ |
423,529 |
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Liabilities,
stockholders’ equity and non-controlling interests |
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Current liabilities: |
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Accounts payable |
$ |
4,353 |
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|
$ |
17,960 |
|
Accrued and other liabilities |
|
164,286 |
|
|
|
172,891 |
|
Deferred revenue |
|
12,863 |
|
|
|
12,740 |
|
Operating lease liabilities, current |
|
15,231 |
|
|
|
14,077 |
|
Total current liabilities |
|
196,733 |
|
|
|
217,668 |
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|
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|
|
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Product development
obligations |
|
17,446 |
|
|
|
17,763 |
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Deferred revenue, net of
current |
|
147,118 |
|
|
|
157,555 |
|
Operating lease liabilities,
non-current |
|
62,511 |
|
|
|
66,537 |
|
Senior secured term loan
facilities, non-current |
|
72,213 |
|
|
|
71,934 |
|
Liability related to sale of
future revenues, non-current |
|
52,216 |
|
|
|
51,413 |
|
Other long-term
liabilities |
|
3,786 |
|
|
|
2,858 |
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Total liabilities |
|
552,023 |
|
|
|
585,728 |
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|
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|
|
|
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Redeemable non-controlling
interests |
|
21,480 |
|
|
|
21,480 |
|
Total stockholders’ deficit
attributable to FibroGen |
|
(228,122 |
) |
|
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(204,166 |
) |
Nonredeemable non-controlling
interests |
|
20,487 |
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|
|
20,487 |
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Total deficit |
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(207,635 |
) |
|
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(183,679 |
) |
Total liabilities,
redeemable non-controlling interests and deficit |
$ |
365,868 |
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$ |
423,529 |
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(1) The condensed consolidated balance sheet
amounts at December 31, 2023 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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2024 |
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|
2023 |
|
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(Unaudited) |
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Revenue: |
|
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License revenue |
$ |
— |
|
|
$ |
6,000 |
|
Development and other revenue |
|
878 |
|
|
|
3,891 |
|
Product revenue, net |
|
30,538 |
|
|
|
24,161 |
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Drug product revenue, net |
|
24,486 |
|
|
|
2,109 |
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Total revenue |
|
55,902 |
|
|
|
36,161 |
|
|
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|
|
|
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Operating costs and
expenses: |
|
|
|
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Cost of goods sold |
|
25,753 |
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|
|
3,491 |
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Research and development |
|
38,392 |
|
|
|
74,486 |
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Selling, general and administrative |
|
22,820 |
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|
|
34,275 |
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Total operating costs and expenses |
|
86,965 |
|
|
|
112,252 |
|
Loss from
operations |
|
(31,063 |
) |
|
|
(76,091 |
) |
|
|
|
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|
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Interest and other,
net: |
|
|
|
|
|
Interest expense |
|
(4,996 |
) |
|
|
(2,372 |
) |
Interest income and other income (expenses), net |
|
2,570 |
|
|
|
1,036 |
|
Total interest and other, net |
|
(2,426 |
) |
|
|
(1,336 |
) |
|
|
|
|
|
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Loss before income
taxes |
|
(33,489 |
) |
|
|
(77,427 |
) |
Provision for income taxes |
|
33 |
|
|
|
74 |
|
Investment income in unconsolidated variable interest entity |
|
589 |
|
|
|
796 |
|
Net loss |
$ |
(32,933 |
) |
|
$ |
(76,705 |
) |
|
|
|
|
|
|
Net loss per share - basic and
diluted |
$ |
(0.33 |
) |
|
$ |
(0.81 |
) |
|
|
|
|
|
|
Weighted average number of
common shares used to calculate net loss per share - basic and
diluted |
|
98,982 |
|
|
|
94,691 |
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Contacts:FibroGen,
Inc.
Investors:David DeLucia, CFAVice
President of Corporate FP&A / Investor
Relationsir@fibrogen.com
Media:Meichiel KeenanDirector,
Investor Relations and Corporate
Communicationsmedia@fibrogen.com
FibroGen (NASDAQ:FGEN)
過去 株価チャート
から 5 2024 まで 6 2024
FibroGen (NASDAQ:FGEN)
過去 株価チャート
から 6 2023 まで 6 2024