FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for
the fourth quarter and full year 2022 and provided an update on the
company’s recent developments.
“We are proud of the significant progress advancing our clinical
pipeline in 2022 and excited and well-prepared to deliver results
from five pivotal phase 3 trials in 2023,” said Enrique Conterno,
Chief Executive Officer, FibroGen. “FibroGen represents a
catalyst-rich opportunity with each of these trials representing an
opportunity to provide a novel treatment to address a significant
unmet medical need.”
Upcoming Milestones:
Pamrevlumab
- Topline data from the LELANTOS-1
Phase 3 study of pamrevlumab in non-ambulatory Duchenne muscular
dystrophy (DMD) patients expected 2Q 2023.
- Topline data from the ZEPHYRUS-1
Phase 3 study of pamrevlumab in idiopathic pulmonary fibrosis (IPF)
expected mid-2023.
- Topline data from the LELANTOS-2
Phase 3 study of pamrevlumab in ambulatory DMD patients expected 3Q
2023.
- Topline data from the LAPIS Phase 3
study of pamrevlumab in locally advanced unresectable pancreatic
cancer (LAPC) expected 1H 2024.
- Topline data from the ZEPHYRUS-2
Phase 3 study of pamrevlumab in IPF expected mid-2024.
Roxadustat
- Topline data from the MATTERHORN
Phase 3 study of roxadustat in anemia of myelodysplastic syndromes
(MDS) expected 2Q 2023.
- Topline data from the China Phase 3
study of roxadustat for the treatment of chemotherapy-induced
anemia (CIA) expected 2Q 2023.
Preclinical
Pipeline
- Expect to file up to two INDs:
FG-3165 (anti-Gal9 antibody) and FG-3163 (anti-CCR8 antibody) in 2H
2023.
Recent Developments and Key Events of 2022
- Completed enrollment of the
LELANTOS-1 Phase 3 clinical trial of pamrevlumab in non-ambulatory
patients with DMD.
- Completed enrollment of the
ZEPHYRUS-1 Phase 3 clinical trial of pamrevlumab in patients with
IPF.
- Our partner Astellas received
approval for roxadustat in Russia for the treatment of adult
patients with symptomatic anemia associated with chronic kidney
disease (CKD), which triggered a $25 million milestone which
FibroGen recorded in 1Q 2022.
- Completed enrollment of the
LELANTOS-2 Phase 3 clinical trial of pamrevlumab in ambulatory
patients with DMD.
- Completed non-dilutive revenue
interest monetization transaction providing $50 million with
NovaQuest Capital Management to support our strategic
priorities.
- Completed enrollment of the
MATTERHORN Phase 3 study of roxadustat in patients with anemia of
MDS.
- In 1Q 2023, completed enrollment of
the China Phase 3 study of roxadustat in patients with
chemotherapy-induced anemia (CIA).
- In 1Q 2023, Partner Eluminex
Biosciences implanted the first patient with a biosynthetic cornea
in their pivotal clinical trial in China.
- Continuation in the Pancreatic
Cancer Action Network's (PanCAN) Precision PromiseSM adaptive trial
platform evaluating pamrevlumab [and standard of care] for patients
with metastatic pancreatic cancer.
China:
- Fourth quarter FibroGen’s net
product revenue under U.S. GAAP from the sale of roxadustat in
China was $23.4 million compared to $5.5 million in the fourth
quarter of 2021, an increase of 328%.
- Full year 2022 FibroGen’s net
product revenue under U.S. GAAP from the sale of roxadustat in
China was $82.9 million compared to $47.6 million in the full year
2021, an increase of 74%.
- Fourth quarter total roxadustat net
sales in China1 by FibroGen and the distribution entity jointly
owned by FibroGen and AstraZeneca (JDE) was $53.1 million, compared
to $32.0 million in the fourth quarter of 2021.
- Full year 2022 total roxadustat net
sales in China1 by FibroGen and the JDE was $208.8 million,
compared to $186.1 million in the full year 2021, 12% growth in net
sales driven by over 80% growth in volume.
- Roxadustat continues to be the
number one brand based on value share in the anemia of CKD market
in China.
Financial:
- Total revenue for the fourth quarter
of 2022 was $34.4 million, as compared to $16.5 million for the
fourth quarter of 2021.
- Total revenue for 2022 was $140.7
million as compared to $235.3 million in 2021, which included $120
million of milestone payments from Astellas related to the EU
approval of roxadustat.
- Net loss for the fourth quarter of
2022 was $66.2 million, or $0.70 net loss per basic and diluted
share, compared to a net loss of $134.1 million, or $1.45 net loss
per basic and diluted share one year ago.
- Net loss for the year was $293.7
million, or $3.14 net loss per basic and diluted share, compared to
a net loss of $290.0 million, or $3.14 net loss per basic and
diluted share one year ago.
- At December 31, 2022, FibroGen had
$442.7 million in cash - defined as cash, cash equivalents,
investments, and accounts receivable.
- Going forward, we believe we are
funded through multiple key clinical milestones and we expect our
cash, cash equivalents, investments, and accounts receivable to be
sufficient to fund our operating plans into the second half of 2024
even without additional financing.
Conference Call and Webcast Details FibroGen
will host a conference call and webcast today, Monday, February 27,
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 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), 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 idiopathic pulmonary fibrosis (IPF), locally advanced
unresectable pancreatic cancer (LAPC), and 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 (ODD), and
Fast Track designation to pamrevlumab for the treatment of patients
with IPF, 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 IPF, DMD, and LAPC.
Pamrevlumab is an investigational drug and not approved for
marketing by any regulatory authority. For information about
pamrevlumab studies currently recruiting patients, 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 anemia of chronic kidney disease (CKD) and anemia associated
with myelodysplastic syndromes (MDS), and for chemotherapy-induced
anemia (CIA).
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 idiopathic pulmonary fibrosis
(IPF), locally advanced unresectable pancreatic cancer (LAPC),
metastatic pancreatic cancer, and 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 Phase 3 clinical development in the U.S. and Europe for
anemia associated with myelodysplastic syndromes (MDS), and in
Phase 3 clinical development in China for treatment of
chemotherapy-induced anemia (CIA). FibroGen recently expanded its
research and development portfolio to include product candidates in
the immuno-oncology and autoimmune space. 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”, the statement
that FibroGen expects its cash, cash equivalents, investments, and
accounts receivable to be sufficient to fund its operating plans
into the second half of 2024 even without additional financing, 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, as filed with the Securities and
Exchange Commission (SEC) on February 27, 2023, 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, 2022 |
|
|
December 31, 2021 |
|
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
155,700 |
|
|
$ |
171,223 |
|
|
Short-term investments |
|
266,308 |
|
|
|
233,967 |
|
|
Accounts receivable, net |
|
16,299 |
|
|
|
17,401 |
|
|
Inventory |
|
40,436 |
|
|
|
31,015 |
|
|
Prepaid expenses and other current assets |
|
14,083 |
|
|
|
20,453 |
|
|
Total current assets |
|
492,826 |
|
|
|
474,059 |
|
|
|
|
|
|
|
|
Restricted time deposits |
|
2,072 |
|
|
|
2,072 |
|
|
Long-term investments |
|
4,348 |
|
|
|
167,796 |
|
|
Property and equipment,
net |
|
20,605 |
|
|
|
28,277 |
|
|
Equity method investment in
unconsolidated variable interest entity |
|
5,061 |
|
|
|
3,825 |
|
|
Operating lease right-of-use
assets |
|
79,893 |
|
|
|
91,112 |
|
|
Other assets |
|
5,282 |
|
|
|
6,680 |
|
|
Total assets |
$ |
610,087 |
|
|
$ |
773,821 |
|
|
|
|
|
|
|
|
Liabilities,
stockholders’ equity and non-controlling interests |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
30,758 |
|
|
$ |
26,097 |
|
|
Accrued and other liabilities |
|
219,773 |
|
|
|
172,599 |
|
|
Deferred revenue |
|
12,739 |
|
|
|
15,857 |
|
|
Operating lease liabilities, current |
|
10,292 |
|
|
|
10,944 |
|
|
Total current liabilities |
|
273,562 |
|
|
|
225,497 |
|
|
|
|
|
|
|
|
Product development
obligations |
|
16,917 |
|
|
|
17,613 |
|
|
Deferred revenue, net of
current |
|
185,722 |
|
|
|
186,801 |
|
|
Operating lease liabilities,
non-current |
|
79,593 |
|
|
|
88,776 |
|
|
Liability related to sale of
future revenues, non-current |
|
49,333 |
|
|
|
— |
|
|
Other long-term
liabilities |
|
6,440 |
|
|
|
26,021 |
|
|
Total liabilities |
|
611,567 |
|
|
|
544,708 |
|
|
|
|
|
|
|
|
Total stockholders’ equity
(deficit) |
|
(21,447 |
) |
|
|
209,146 |
|
|
Non-controlling interests |
|
19,967 |
|
|
|
19,967 |
|
|
Total equity (deficit) |
|
(1,480 |
) |
|
|
229,113 |
|
|
Total liabilities,
stockholders’ equity and non-controlling interests |
$ |
610,087 |
|
|
$ |
773,821 |
|
|
(1) The condensed consolidated
balance sheet amounts at December 31, 2021 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, |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(1) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
22,590 |
|
|
$ |
116,434 |
|
Development and other revenue |
|
4,517 |
|
|
|
9,951 |
|
|
|
24,189 |
|
|
|
70,275 |
|
Product revenue, net |
|
23,374 |
|
|
|
5,463 |
|
|
|
82,869 |
|
|
|
47,638 |
|
Drug product revenue |
|
6,476 |
|
|
|
1,129 |
|
|
|
11,086 |
|
|
|
962 |
|
Total revenue |
|
34,367 |
|
|
|
16,543 |
|
|
|
140,734 |
|
|
|
235,309 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
4,924 |
|
|
|
3,125 |
|
|
|
20,280 |
|
|
|
12,871 |
|
Research and development |
|
61,628 |
|
|
|
113,920 |
|
|
|
296,791 |
|
|
|
387,043 |
|
Selling, general and administrative |
|
33,966 |
|
|
|
34,739 |
|
|
|
124,688 |
|
|
|
123,925 |
|
Total operating costs and expenses |
|
100,518 |
|
|
|
151,784 |
|
|
|
441,759 |
|
|
|
523,839 |
|
Loss from
operations |
|
(66,151 |
) |
|
|
(135,241 |
) |
|
|
(301,025 |
) |
|
|
(288,530 |
) |
|
|
|
|
|
|
|
|
|
|
|
Interest and other,
net: |
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(1,119 |
) |
|
|
(110 |
) |
|
|
(1,440 |
) |
|
|
(1,075 |
) |
Interest income and other income (expenses), net |
|
923 |
|
|
|
1,042 |
|
|
|
7,596 |
|
|
|
(1,078 |
) |
Total interest and other, net |
|
(196 |
) |
|
|
932 |
|
|
|
6,156 |
|
|
|
(2,153 |
) |
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes |
|
(66,347 |
) |
|
|
(134,309 |
) |
|
|
(294,869 |
) |
|
|
(290,683 |
) |
Provision for income taxes |
|
108 |
|
|
|
112 |
|
|
|
358 |
|
|
|
347 |
|
Investment income in unconsolidated variable interest
entity |
|
280 |
|
|
|
342 |
|
|
|
1,573 |
|
|
|
1,007 |
|
Net loss |
$ |
(66,175 |
) |
|
$ |
(134,079 |
) |
|
$ |
(293,654 |
) |
|
$ |
(290,023 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
$ |
(0.70 |
) |
|
$ |
(1.45 |
) |
|
$ |
(3.14 |
) |
|
$ |
(3.14 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares used to calculate net loss per share - basic and
diluted |
|
94,032 |
|
|
|
92,774 |
|
|
|
93,582 |
|
|
|
92,349 |
|
(1) The condensed consolidated
statement of operations amounts for the year ended
December 31, 2021 are derived from audited financial
statements.
Contacts:FibroGen, Inc.
Investors:Michael Tung, M.D.Corporate Strategy
/ Investor Relations415.978.1434mtung@fibrogen.com
Media:Meichiel KeenanInvestor Relations and
Corporate Communicationsmkeenan@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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