FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for
the third quarter 2023 and provided an update on the Company’s
recent developments.
“Today, we reported another quarter of strong roxadustat volume
growth in China, achieving the highest ever value share, at 42%, in
the anemia of CKD category,” said Thane Wettig, Chief Executive
Officer, FibroGen. “The continued strength of our China business,
sooner than expected realization of our corporate cost reduction
efforts and our strong balance sheet provide us a cash runway into
2026. Over the next 12 months, we will obtain data read-outs from
our two late-stage pancreatic cancer trials, start a Phase 2
metastatic castrate-resistant prostate cancer trial, and file two
immuno-oncology INDs. 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.”
Recent Developments and Key Events of Third Quarter
2023:
- Appointed Thane Wettig as Chief Executive Officer.
- Supplemental New Drug Application (sNDA) accepted by the China
Health Authority for roxadustat for the treatment of patients with
chemotherapy-induced anemia (CIA). Expect approval decision of CIA
in China in mid-2024.
- Successful implementation of cost reduction plan, now resulting
in an expected reduction of total annualized expenses of $120
million.
- Reported negative topline results from the LELANTOS-2 Phase 3
study of pamrevlumab for the treatment of ambulatory patients with
Duchenne muscular dystrophy (DMD).
- Presented Phase 3 data of roxadustat for CIA in patients with
non-myeloid malignancies in an oral presentation at the European
Society for Medical Oncology Congress 2023.
- FibroGen and its partners presented five roxadustat abstracts,
including four poster presentations and one late-breaker poster
presentation, at the recent American Society of Nephrology (ASN)
Kidney Week 2023 conference.
- Presented preclinical data for the FG-3165 anti-Gal9 antibody
program at the Society for Immunotherapy of Cancer Annual Meeting
2023.
China Performance:
- Achieved third quarter net product revenue under U.S. GAAP from
the sale of roxadustat in China of $29.4 million compared to $17.4
million in the third quarter of 2022, an increase of 69% year over
year.
- Achieved third quarter total roxadustat net sales in China1 by
FibroGen and the distribution entity (JDE) jointly owned by
FibroGen and AstraZeneca of $77.1 million, compared to $59.0
million in the third quarter of 2022, an increase of 31% year over
year, driven by 37% 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 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.
Oncology Pipeline
- Expect topline clinical trial results from Phase 1 monotherapy
trial of FG-3246, a first-in-class antibody-drug conjugate (ADC)
targeting a novel epitope on CD46 for metastatic
castration-resistant prostate cancer (mCRPC) by 1Q 2024.
- Anticipate the initiation of a Phase 2 trial of FG-3246 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 third quarter of 2023 was $40.1 million,
as compared to $15.7 million for the third quarter of 2022, an
increase of 155% year over year.
- Net loss for the third quarter of 2023 was $63.6 million, or
$0.65 net loss per basic and diluted share, compared to a net loss
of $91.7 million, or $0.98 net loss per basic and diluted share one
year ago.
- Restructuring charge for the third quarter of 2023 was $12.6
million, or $0.13 impact to net loss per basic and diluted share,
resulting from the reduction in U.S. workforce announced in July
2023.
- At September 30, 2023, cash – defined as cash, cash
equivalents, investments, and accounts receivable – was $283.0
million.
- 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, November 6,
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). 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. 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 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 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) and metastatic pancreatic cancer.
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) and a
Supplemental New Drug Application (sNDA) has been accepted by the
China Health Authority. FibroGen recently expanded its research and
development portfolio to include product candidates in oncology.
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
company’s financial performance, 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 September 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)
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
120,914 |
|
|
$ |
155,700 |
|
Short-term investments |
|
130,426 |
|
|
|
266,308 |
|
Accounts receivable, net |
|
31,694 |
|
|
|
16,299 |
|
Inventory |
|
40,696 |
|
|
|
40,436 |
|
Prepaid expenses and other current assets |
|
40,378 |
|
|
|
14,083 |
|
Total current assets |
|
364,108 |
|
|
|
492,826 |
|
|
|
|
|
|
|
|
Restricted time deposits |
|
2,072 |
|
|
|
2,072 |
|
Long-term investments |
|
— |
|
|
|
4,348 |
|
Property and equipment, net |
|
14,512 |
|
|
|
20,605 |
|
Equity method investment in unconsolidated variable interest
entity |
|
4,534 |
|
|
|
5,061 |
|
Operating lease right-of-use assets |
|
71,248 |
|
|
|
79,893 |
|
Other
assets |
|
3,952 |
|
|
|
5,282 |
|
Total assets |
$ |
460,426 |
|
|
$ |
610,087 |
|
|
|
|
|
|
|
|
Liabilities, stockholders’ equity and non-controlling
interests |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
19,220 |
|
|
$ |
30,758 |
|
Accrued and other liabilities |
|
170,986 |
|
|
|
219,773 |
|
Deferred revenue |
|
7,325 |
|
|
|
12,739 |
|
Operating lease liabilities, current |
|
11,884 |
|
|
|
10,292 |
|
Total current liabilities |
|
209,415 |
|
|
|
273,562 |
|
|
|
|
|
|
Product development obligations |
|
16,942 |
|
|
|
16,917 |
|
Deferred revenue, net of current |
|
154,206 |
|
|
|
185,722 |
|
Operating lease liabilities, non-current |
|
70,035 |
|
|
|
79,593 |
|
Senior secured term loan facilities, non-current |
|
71,666 |
|
|
|
— |
|
Liability related to sale of future revenues, non-current |
|
49,109 |
|
|
|
49,333 |
|
Other
long-term liabilities |
|
4,255 |
|
|
|
6,440 |
|
Total liabilities |
|
575,628 |
|
|
|
611,567 |
|
|
|
|
|
|
Redeemable non-controlling interests |
|
21,480 |
|
|
|
— |
|
Total
stockholders’ deficit attributable to FibroGen |
|
(157,169 |
) |
|
|
(21,447 |
) |
Nonredeemable non-controlling interests |
|
20,487 |
|
|
|
19,967 |
|
Total
deficit |
|
(136,682 |
) |
|
|
(1,480 |
) |
Total liabilities, redeemable non-controlling interests and
deficit |
$ |
460,426 |
|
|
$ |
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
2,649 |
|
|
$ |
— |
|
|
$ |
9,649 |
|
|
$ |
22,590 |
|
Development and other revenue |
|
6,775 |
|
|
|
2,453 |
|
|
|
15,825 |
|
|
|
19,672 |
|
Product revenue, net |
|
29,390 |
|
|
|
17,359 |
|
|
|
77,439 |
|
|
|
59,495 |
|
Drug product revenue, net |
|
1,320 |
|
|
|
(4,077 |
) |
|
|
17,701 |
|
|
|
4,610 |
|
Total revenue |
|
40,134 |
|
|
|
15,735 |
|
|
|
120,614 |
|
|
|
106,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
4,243 |
|
|
|
4,308 |
|
|
|
13,441 |
|
|
|
15,355 |
|
Research and development |
|
61,194 |
|
|
|
75,182 |
|
|
|
231,158 |
|
|
|
235,163 |
|
Selling, general and administrative |
|
25,573 |
|
|
|
29,902 |
|
|
|
91,029 |
|
|
|
90,722 |
|
Restructuring charge |
|
12,606 |
|
|
|
— |
|
|
|
12,606 |
|
|
|
— |
|
Total operating costs and expenses |
|
103,616 |
|
|
|
109,392 |
|
|
|
348,234 |
|
|
|
341,240 |
|
Loss from
operations |
|
(63,482 |
) |
|
|
(93,657 |
) |
|
|
(227,620 |
) |
|
|
(234,873 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other,
net: |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(5,022 |
) |
|
|
(84 |
) |
|
|
(10,464 |
) |
|
|
(321 |
) |
Interest income and other income (expenses), net |
|
4,296 |
|
|
|
1,798 |
|
|
|
7,984 |
|
|
|
6,672 |
|
Total interest and other, net |
|
(726 |
) |
|
|
1,714 |
|
|
|
(2,480 |
) |
|
|
6,351 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes |
|
(64,208 |
) |
|
|
(91,943 |
) |
|
|
(230,100 |
) |
|
|
(228,522 |
) |
Provision for (benefit from) income taxes |
|
84 |
|
|
|
114 |
|
|
|
(77 |
) |
|
|
250 |
|
Investment income in unconsolidated variable interest entity |
|
677 |
|
|
|
407 |
|
|
|
2,023 |
|
|
|
1,293 |
|
Net loss |
$ |
(63,615 |
) |
|
$ |
(91,650 |
) |
|
$ |
(228,000 |
) |
|
$ |
(227,479 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
$ |
(0.65 |
) |
|
$ |
(0.98 |
) |
|
$ |
(2.35 |
) |
|
$ |
(2.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares used to calculate net loss per share - basic and
diluted |
|
98,245 |
|
|
|
93,767 |
|
|
|
96,901 |
|
|
|
93,431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:FibroGen, Inc.
Investors:David DeLucia, CFAVice President of
Corporate FP&A / Investor Relationsddelucia@fibrogen.com
Media:Meichiel KeenanDirector, Investor
Relations and Corporate Communicationsmkeenan@fibrogen.com
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