FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for
the fourth quarter and full year 2023 and provided an update on the
company’s recent developments.
“We are extremely excited about the company’s prospects in
2024,” said Thane Wettig, Chief Executive Officer, FibroGen. “In
this year alone, we will obtain data read-outs from our two
late-stage pancreatic cancer trials, start a Phase 2 metastatic
castration-resistant prostate cancer trial, file an immuno-oncology
IND, and potentially receive approval for roxadustat in
chemotherapy-induced anemia in China. Furthermore, the continued
strength of our China business, accelerated realization of our
corporate cost reduction program, and our strong balance sheet
provide us a cash runway into 2026. These unique and exciting
programs, combined with the quality of our talented colleagues,
provide a strong foundation to create significant value for
shareholders relative to our current valuation.”
Upcoming Milestones:
Pamrevlumab
- Topline data from the PanCAN Precision Promise℠ Phase 2/3
study of pamrevlumab in metastatic pancreatic cancer expected in 2Q
2024.
- Topline data from the LAPIS Phase 3 study of pamrevlumab in
locally advanced unresectable pancreatic cancer (LAPC) expected in
2Q 2024.
Roxadustat
- Expect approval decision for roxadustat in chemotherapy-induced
anemia (CIA) in China in mid-2024. If approved, FibroGen will
receive a $10M milestone payment from AstraZeneca.
Oncology Pipeline
- Additional data from Phase 1 monotherapy study of FG-3246 in
metastatic castration-resistant prostate cancer (mCRPC) expected in
1Q 2024.
- Anticipate the initiation of a Phase 2 study of FG-3246 in
mCRPC in 2H 2024.
- Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody)
in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2025.
Recent Developments and Key Highlights of
2023:
Pamrevlumab
- Announced graduation and completion of the pamrevlumab arm in
Precision Promise℠, Pancreatic Cancer Action Network’s Phase 2/3
adaptive platform trial for metastatic pancreatic cancer.
- Pamrevlumab, in Stage 1 of the trial, achieved a protocol
pre-specified ≥ 35% predictive probability of success for the
primary endpoint of overall survival at the completion of the
trial.
Roxadustat
- Regained all rights to roxadustat from AstraZeneca in the
United States and other AstraZeneca territories, except China and
South Korea.
- Presented data from Phase 3 MATTERHORN study of roxadustat in
patients with anemia of lower risk transfusion-dependent
myelodysplastic syndromes at American Society of Hematology Annual
Meeting.
Corporate
- Thane Wettig appointed Chief Executive Officer.
- Successful execution of cost reduction plan, resulting in a
reduction of total annualized expenses of $120 million.
China:
- Fourth quarter FibroGen’s net product revenue under U.S. GAAP
from the sale of roxadustat in China was $23.5 million compared to
$23.4 million in the fourth quarter of 2022.
- Full year 2023 FibroGen’s net product revenue under U.S. GAAP
from the sale of roxadustat in China was $100.9 million compared to
$82.9 million in the full year 2022, an increase of 22%.
- Fourth quarter total roxadustat net sales in China¹ by
FibroGen and the distribution entity jointly owned by FibroGen and
AstraZeneca (JDE) was $66.5 million, compared to $53.1 million in
the fourth quarter of 2022, an increase of 25%.
- Full year 2023 total roxadustat net sales in China¹ by
FibroGen and the JDE was $284.1 million, compared to $208.8 million
in the full year 2022, an increase of 36%, driven by over 41%
growth in volume.
- Roxadustat continues to be the number one brand based on value
share in the anemia of CKD market in China and has secured renewal
on the National Reimbursement Drug List.
- For 2024, we anticipate 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 fourth quarter of 2023 was $27.1 million,
as compared to $34.4 million for the fourth quarter of 2022.
Reduction primarily driven by the change in net product revenue
assumptions under U.S. GAAP and drug product revenue shipment
timing.
- Total revenue for full year 2023 was $147.8 million as compared
to $140.7 million in 2022.
- Net loss for the fourth quarter of 2023 was $56.2 million, or
$0.57 net loss per basic and diluted share, compared to a net loss
of $66.2 million, or $0.70 net loss per basic and diluted share one
year ago.
- Net loss for the year was $284.2 million, or $2.92 net loss per
basic and diluted share, compared to a net loss of $293.7 million,
or $3.14 net loss per basic and diluted share one year ago.
- At December 31, 2023, FibroGen had $248.1 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,
February 26, 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 Pamrevlumab
Pamrevlumab 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 Roxadustat
Roxadustat, 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, an anti-CTGF fully human 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. FibroGen recently expanded its research and development
portfolio to include antibody-drug conjugate (ADC) and
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 the development and
commercialization of roxadustat, including its commercial
potential, and the potential safety and efficacy profile of
roxadustat. These forward-looking statements include but are not
limited to 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.
Condensed Consolidated Balance Sheets(In
thousands)
|
|
December 31, 2023 |
|
|
December 31, 2022 |
|
|
(Unaudited) |
|
|
(1) |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
113,688 |
|
|
$ |
155,700 |
|
Short-term investments |
|
|
121,898 |
|
|
|
266,308 |
|
Accounts receivable, net |
|
|
12,553 |
|
|
|
16,299 |
|
Inventory |
|
|
41,565 |
|
|
|
40,436 |
|
Prepaid expenses and other current assets |
|
|
41,855 |
|
|
|
14,083 |
|
Total current assets |
|
|
331,559 |
|
|
|
492,826 |
|
|
|
|
|
|
|
Restricted time deposits |
|
|
1,658 |
|
|
|
2,072 |
|
Long-term investments |
|
|
— |
|
|
|
4,348 |
|
Property and equipment,
net |
|
|
13,126 |
|
|
|
20,605 |
|
Equity method investment in
unconsolidated variable interest entity |
|
|
5,290 |
|
|
|
5,061 |
|
Operating lease right-of-use
assets |
|
|
68,093 |
|
|
|
79,893 |
|
Other assets |
|
|
3,803 |
|
|
|
5,282 |
|
Total assets |
|
$ |
423,529 |
|
|
$ |
610,087 |
|
|
|
|
|
|
|
Liabilities,
stockholders’ equity and non-controlling interests |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
17,960 |
|
|
$ |
30,758 |
|
Accrued and other liabilities |
|
|
172,891 |
|
|
|
219,773 |
|
Deferred revenue |
|
|
12,740 |
|
|
|
12,739 |
|
Operating lease liabilities, current |
|
|
14,077 |
|
|
|
10,292 |
|
Total current liabilities |
|
|
217,668 |
|
|
|
273,562 |
|
|
|
|
|
|
|
Product development
obligations |
|
|
17,763 |
|
|
|
16,917 |
|
Deferred revenue, net of
current |
|
|
157,555 |
|
|
|
185,722 |
|
Operating lease liabilities,
non-current |
|
|
66,537 |
|
|
|
79,593 |
|
Senior secured term loan
facilities, non-current |
|
|
71,934 |
|
|
|
— |
|
Liability related to sale of
future revenues, non-current |
|
|
51,413 |
|
|
|
49,333 |
|
Other long-term
liabilities |
|
|
2,858 |
|
|
|
6,440 |
|
Total liabilities |
|
|
585,728 |
|
|
|
611,567 |
|
|
|
|
|
|
|
Redeemable non-controlling
interests |
|
|
21,480 |
|
|
|
— |
|
Total stockholders’ deficit
attributable to FibroGen |
|
|
(204,166 |
) |
|
|
(21,447 |
) |
Nonredeemable non-controlling
interests |
|
|
20,487 |
|
|
|
19,967 |
|
Total deficit |
|
|
(183,679 |
) |
|
|
(1,480 |
) |
Total liabilities,
redeemable non-controlling interests and deficit |
|
$ |
423,529 |
|
|
$ |
610,087 |
|
|
(1) The condensed consolidated balance
sheet amounts at December 31, 2022 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, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(1) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
License revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9,649 |
|
|
$ |
22,590 |
|
Development and other revenue |
|
|
2,575 |
|
|
|
4,517 |
|
|
|
18,401 |
|
|
|
24,189 |
|
Product revenue, net |
|
|
23,510 |
|
|
|
23,374 |
|
|
|
100,949 |
|
|
|
82,869 |
|
Drug product revenue, net |
|
|
1,052 |
|
|
|
6,476 |
|
|
|
18,753 |
|
|
|
11,086 |
|
Total revenue |
|
|
27,137 |
|
|
|
34,367 |
|
|
|
147,752 |
|
|
|
140,734 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
5,406 |
|
|
|
4,924 |
|
|
|
18,848 |
|
|
|
20,280 |
|
Research and development |
|
|
51,702 |
|
|
|
61,628 |
|
|
|
282,861 |
|
|
|
296,791 |
|
Selling, general and administrative |
|
|
24,224 |
|
|
|
33,966 |
|
|
|
115,252 |
|
|
|
124,688 |
|
Restructuring charge |
|
|
— |
|
|
|
— |
|
|
|
12,606 |
|
|
|
— |
|
Total operating costs and expenses |
|
|
81,332 |
|
|
|
100,518 |
|
|
|
429,567 |
|
|
|
441,759 |
|
Loss from
operations |
|
|
(54,195 |
) |
|
|
(66,151 |
) |
|
|
(281,815 |
) |
|
|
(301,025 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other,
net: |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(5,068 |
) |
|
|
(1,119 |
) |
|
|
(15,532 |
) |
|
|
(1,440 |
) |
Interest income and other income (expenses), net |
|
|
2,496 |
|
|
|
923 |
|
|
|
10,480 |
|
|
|
7,596 |
|
Total interest and other, net |
|
|
(2,572 |
) |
|
|
(196 |
) |
|
|
(5,052 |
) |
|
|
6,156 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes |
|
|
(56,767 |
) |
|
|
(66,347 |
) |
|
|
(286,867 |
) |
|
|
(294,869 |
) |
Provision for (benefit from) income taxes |
|
|
80 |
|
|
|
108 |
|
|
|
3 |
|
|
|
358 |
|
Investment income in unconsolidated variable interest entity |
|
|
615 |
|
|
|
280 |
|
|
|
2,638 |
|
|
|
1,573 |
|
Net loss |
|
$ |
(56,232 |
) |
|
$ |
(66,175 |
) |
|
$ |
(284,232 |
) |
|
$ |
(293,654 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
|
$ |
(0.57 |
) |
|
$ |
(0.70 |
) |
|
$ |
(2.92 |
) |
|
$ |
(3.14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares used to calculate net loss per share - basic and
diluted |
|
|
98,496 |
|
|
|
94,032 |
|
|
|
97,303 |
|
|
|
93,582 |
|
|
(1) The condensed consolidated statement
of operations amounts for the year ended December 31, 2022 are
derived from audited financial statements.
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
_________________________________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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