FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for
the second quarter 2023 and provided an update on the Company’s
recent developments.
“We saw another record quarter of roxadustat sales in China, and
we recently submitted the sNDA to the China Health Authority for
chemotherapy-induced anemia,” said Thane Wettig, Interim Chief
Executive Officer, FibroGen. “As I assume the leadership role, I am
very optimistic about our future. Within the next year, we have
three pamrevlumab read-outs and key milestones for our early-stage
pipeline, which combined with our deeply experienced team and
strong cash position, set us up well for delivering value to
patients and shareholders.”
Recent Developments and Key Events of Second Quarter
2023:
- Appointed Thane Wettig as Interim
Chief Executive Officer.
- Entered into exclusive license for
FOR46 (now FG-3246), a first-in-class CD46-targeting ADC for the
treatment of metastatic castration-resistant prostate cancer
(mCRPC).
- Reported positive topline data from
Company’s Phase 3 clinical study of roxadustat for treatment of
anemia in patients receiving concurrent chemotherapy treatment for
non-myeloid malignancies in China.
- Filed Supplemental New Drug
Application (sNDA) with China Health Authority for roxadustat in
patients with chemotherapy-induced anemia.
- Announced a non-dilutive term loan
facility with investment funds managed by Morgan Stanley Tactical
Value (MSTV), which resulted in proceeds to FibroGen of $75
million.
- Reported negative topline results
from MATTERHORN Phase 3 clinical study of roxadustat for treatment
of anemia in patients with transfusion-dependent lower risk
myelodysplastic syndromes (MDS).
- Reported negative topline results
from the LELANTOS-1 Phase 3 study of pamrevlumab for the treatment
of non-ambulatory patients with Duchenne muscular dystrophy
(DMD).
- Reported negative topline results
from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in patients with
idiopathic pulmonary fibrosis (IPF). Discontinued ZEPHYRUS-2 Phase
3 study of pamrevlumab in patients with IPF.
- Implemented a cost reduction plan,
resulting in an expected reduction of total annualized U.S. GAAP
expenses of $100-120 million.
China Performance:
- Achieved second quarter net product
revenue under U.S. GAAP from the sale of roxadustat in China of
$23.9 million compared to $23.3 million in the second quarter of
2022.
- Achieved second quarter total
roxadustat net sales in China1 by FibroGen and the distribution
entity (JDE) jointly owned by FibroGen and AstraZeneca of $76.4
million, compared to $53.1 million in the second quarter of 2022,
an increase of 44%, driven by over 40% growth in volume.
- Roxadustat continues to be the
number one brand based on value share in the anemia of chronic
kidney disease market in China.
Upcoming Milestones:
Pamrevlumab
- Topline data from the LELANTOS-2
Phase 3 study of pamrevlumab in ambulatory DMD patients expected in
3Q 2023.
- Topline data from the LAPIS Phase 3
study of pamrevlumab in locally advanced unresectable pancreatic
cancer (LAPC) expected in 1Q 2024.
- Topline data from the PanCAN
Precision PromiseSM Phase 2/3 study of pamrevlumab in metastatic
pancreatic cancer expected in 1H 2024.
Early-Stage Oncology Pipeline
- Anticipate the initiation of a Phase
2 trial of FG-3246, a first-in-class ADC targeting a novel epitope
on CD46 for 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 2H 2024.
Financial:
- Total revenue for the second quarter
of 2023 was $44.3 million, as compared to $29.8 million for the
second quarter of 2022, an increase of 49%.
- Net loss for the second quarter of
2023 was $87.7 million, or $0.90 net loss per basic and diluted
share, compared to a net loss of $72.6 million, or $0.78 net loss
per basic and diluted share one year ago.
- Research and development expenses
for the second quarter of 2023 included a one-time, non-cash charge
of acquired in-process research and development expenses of $24.6
million, or $0.25 impact to net loss per basic and diluted share,
resulting from the recent exclusive license for FG-3246 from Fortis
Therapeutics.
- At June 30, 2023, cash – defined as
cash, cash equivalents, investments, and accounts receivable – was
$361.3 million, including proceeds received during the quarter from
the Company’s use of its at-the-market equity facility and the
closing of the recently announced term loan.
- We expect our cash, cash
equivalents, investments, and accounts receivable to be sufficient
to fund our operating plans into 2026.
_______________________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.
Conference Call and Webcast Details FibroGen
will host a conference call and webcast today, Monday, August 7,
2023, 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 in to 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), a common factor
in fibrotic and proliferative disorders characterized by persistent
and excessive scarring that can lead to organ dysfunction and
failure. Pamrevlumab is in Phase 3 clinical development for the
treatment of locally advanced unresectable pancreatic cancer
(LAPC), ambulatory Duchenne muscular dystrophy (DMD), 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 DMD and LAPC. The U.S. Food and Drug Administration
has also granted Rare Pediatric Disease Designation to pamrevlumab
for the treatment of patients with DMD. Pamrevlumab has
demonstrated a safety and tolerability profile that has supported
ongoing clinical investigation in DMD, 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) in China.
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. FibroGen and
AstraZeneca are collaborating on the development and
commercialization of roxadustat for the potential treatment of
anemia in the U.S., China, and other markets not licensed to
Astellas.
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 connective tissue
growth factor (CTGF) biology and hypoxia-inducible factor (HIF) to
advance innovative medicines for the treatment of unmet needs.
Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical
development for the treatment of locally advanced unresectable
pancreatic cancer (LAPC), metastatic pancreatic cancer, and
ambulatory Duchenne muscular dystrophy (DMD). Roxadustat (爱瑞卓®,
EVRENZO™) is currently approved in China, Europe, Japan, and
numerous other countries for the treatment of anemia in CKD
patients on dialysis and not on dialysis. Roxadustat is in clinical
development for chemotherapy-induced anemia (CIA) in China.
FibroGen recently expanded its research and development portfolio
to include product candidates in the immuno-oncology space along
with an exclusive license for FG-3246. 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 the company’s product
candidates, the potential safety and efficacy profile of its
product candidates, and its clinical programs. These
forward-looking statements include, but are not limited to,
statements under the caption “Upcoming Milestones”, statements
regarding the expected cost reduction savings, the statement that
FibroGen expects its cash, cash equivalents, investments, and
accounts receivable to be sufficient to fund its operating plans
into 2026, 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, 2022, and our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023,
each 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) |
|
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
|
(Unaudited) |
|
|
(1) |
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
$ |
152,585 |
|
|
$ |
155,700 |
|
Short-term investments |
|
183,131 |
|
|
|
266,308 |
|
Accounts receivable, net |
|
25,599 |
|
|
|
16,299 |
|
Inventory |
|
41,179 |
|
|
|
40,436 |
|
Prepaid expenses and other current assets |
|
8,863 |
|
|
|
14,083 |
|
Total current assets |
|
411,357 |
|
|
|
492,826 |
|
|
|
|
|
|
|
Restricted time
deposits |
|
2,072 |
|
|
|
2,072 |
|
Long-term
investments |
|
— |
|
|
|
4,348 |
|
Property and
equipment, net |
|
16,829 |
|
|
|
20,605 |
|
Equity method
investment in unconsolidated variable interest entity |
|
6,112 |
|
|
|
5,061 |
|
Operating lease
right-of-use assets |
|
74,404 |
|
|
|
79,893 |
|
Other assets |
|
4,353 |
|
|
|
5,282 |
|
Total assets |
$ |
515,127 |
|
|
$ |
610,087 |
|
|
|
|
|
|
|
Liabilities, stockholders’ equity and non-controlling
interests |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
$ |
12,802 |
|
|
$ |
30,758 |
|
Accrued and other liabilities |
|
162,769 |
|
|
|
219,773 |
|
Deferred revenue |
|
7,490 |
|
|
|
12,739 |
|
Operating lease liabilities, current |
|
11,011 |
|
|
|
10,292 |
|
Total current liabilities |
|
194,072 |
|
|
|
273,562 |
|
|
|
|
|
|
|
Product
development obligations |
|
17,365 |
|
|
|
16,917 |
|
Deferred revenue,
net of current |
|
165,416 |
|
|
|
185,722 |
|
Operating lease
liabilities, non-current |
|
73,813 |
|
|
|
79,593 |
|
Senior secured
term loan facilities, non-current |
|
71,408 |
|
|
|
— |
|
Liability related
to sale of future revenues, non-current |
|
48,399 |
|
|
|
49,333 |
|
Other long-term
liabilities |
|
4,961 |
|
|
|
6,440 |
|
Total liabilities |
|
575,434 |
|
|
|
611,567 |
|
|
|
|
|
|
|
Redeemable
non-controlling interests |
|
21,480 |
|
|
|
— |
|
Total
stockholders’ deficit attributable to FibroGen |
|
(102,274 |
) |
|
|
(21,447 |
) |
Nonredeemable
non-controlling interests |
|
20,487 |
|
|
|
19,967 |
|
Total deficit |
|
(81,787 |
) |
|
|
(1,480 |
) |
Total
liabilities, redeemable non-controlling interests and
deficit |
$ |
515,127 |
|
|
$ |
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 June 30, |
|
|
Six Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
1,000 |
|
|
$ |
— |
|
|
$ |
7,000 |
|
|
$ |
22,590 |
|
Development and other revenue |
|
5,158 |
|
|
|
5,457 |
|
|
|
9,050 |
|
|
|
17,219 |
|
Product revenue, net |
|
23,889 |
|
|
|
23,256 |
|
|
|
48,049 |
|
|
|
42,137 |
|
Drug product revenue, net |
|
14,272 |
|
|
|
1,093 |
|
|
|
16,381 |
|
|
|
8,687 |
|
Total revenue |
|
44,319 |
|
|
|
29,806 |
|
|
|
80,480 |
|
|
|
90,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
5,708 |
|
|
|
6,809 |
|
|
|
9,199 |
|
|
|
11,048 |
|
Research and development |
|
95,478 |
|
|
|
70,963 |
|
|
|
169,964 |
|
|
|
159,981 |
|
Selling, general and administrative |
|
31,181 |
|
|
|
30,258 |
|
|
|
65,455 |
|
|
|
60,820 |
|
Total operating costs and expenses |
|
132,367 |
|
|
|
108,030 |
|
|
|
244,618 |
|
|
|
231,849 |
|
Loss from
operations |
|
(88,048 |
) |
|
|
(78,224 |
) |
|
|
(164,138 |
) |
|
|
(141,216 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other,
net: |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(3,069 |
) |
|
|
(141 |
) |
|
|
(5,441 |
) |
|
|
(238 |
) |
Interest income and other income (expenses), net |
|
2,652 |
|
|
|
5,199 |
|
|
|
3,687 |
|
|
|
4,876 |
|
Total interest and other, net |
|
(417 |
) |
|
|
5,058 |
|
|
|
(1,754 |
) |
|
|
4,638 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes |
|
(88,465 |
) |
|
|
(73,166 |
) |
|
|
(165,892 |
) |
|
|
(136,578 |
) |
Provision for income taxes |
|
(235 |
) |
|
|
23 |
|
|
|
(161 |
) |
|
|
136 |
|
Investment income in unconsolidated variable interest
entity |
|
550 |
|
|
|
565 |
|
|
|
1,346 |
|
|
|
885 |
|
Net loss |
$ |
(87,680 |
) |
|
$ |
(72,624 |
) |
|
$ |
(164,385 |
) |
|
$ |
(135,829 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
$ |
(0.90 |
) |
|
$ |
(0.78 |
) |
|
$ |
(1.71 |
) |
|
$ |
(1.46 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares used to calculate net loss per share -
basic and diluted |
|
97,729 |
|
|
|
93,475 |
|
|
|
96,218 |
|
|
|
93,260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:FibroGen, Inc.
Investors:David DeLucia, CFAHead of Corporate
FP&A / Investor Relationsddelucia@fibrogen.com
Media:Michael
Szumeramszumera@fibrogen.com
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