FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for
the third quarter 2022 and provided an update on the company’s
recent developments.
“I am very pleased with our progress across our clinical
development programs with 3 pivotal trials expected to read out for
pamrevlumab in 2023 and two more in 2024. Notably, our Phase 3
trials of roxadustat in the U.S. and Europe for anemia of
myelodysplastic syndromes, and chemotherapy-induced anemia in China
add two more pivotal readouts next year,” said Enrique Conterno,
Chief Executive Officer, FibroGen. “The strategic financing
transaction with NovaQuest provides additional non-dilutive capital
which strengthens our balance sheet to support the development and
commercialization of pamrevlumab while continuing to advance and
expand our pipeline.”
Recent Developments:
- Announced non-dilutive royalty
monetization transaction with NovaQuest Capital Management secured
by 22.5% of roxadustat royalty revenue in the territories licensed
to Astellas Pharma Inc., providing $50 million to support our
strategic priorities.
- Completed enrollment of the
MATTERHORN Phase 3 study of roxadustat in patients with anemia of
myelodysplastic syndromes (MDS).
- Roxadustat continues to gain
approvals in additional countries around the world. It is now
approved in China, Europe, Japan, and numerous other territories
for the treatment of anemia in chronic kidney disease (CKD)
patients on dialysis and not on dialysis.
China Performance:
- FibroGen’s net
product revenue under U.S. GAAP from the sale of roxadustat in
China was $17.4 million compared to $13.4 million in the third
quarter of 2021, an increase of 29%.
- Third quarter total
roxadustat net sales in China1 by FibroGen and the distribution
entity (JDE) jointly owned by FibroGen, and AstraZeneca was $59.0
million, compared to $57.8 million in the third quarter of
2021.
- Roxadustat continues
to be the number one brand based on value share in the anemia of
CKD market in China.
Upcoming Milestones:
Pamrevlumab
- Topline data from the LELANTOS-1 Phase 3 study of pamrevlumab
in non-ambulatory DMD patients expected 1H 2023.
- Topline data from the ZEPHYRUS-1 Phase 3 study of pamrevlumab
in IPF expected mid-2023.
- Topline data from the LELANTOS-2 Phase 3 study of pamrevlumab
in ambulatory DMD patients expected 2H 2023.
- Topline data from the LAPIS Phase 3 study of pamrevlumab in
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 MDS expected 1H 2023.
- Topline data from the China Phase 3 study of roxadustat for the
treatment of chemotherapy-induced anemia (CIA) expected
mid-2023.
Financial:
- Total revenue for the third quarter
of 2022 was $15.7 million, as compared to $156.0 million for the
third quarter of 2021, which included $120 million of milestone
payments from Astellas related to the EU approval of
roxadustat.
- Net loss for the third quarter of
2022 was $91.7 million, or $0.98 net loss per basic and diluted
share, compared to a net income of $49.8 million, or $0.54 net
income per basic and diluted share one year ago.
- At September 30, 2022, FibroGen had
$441.6 million in cash - defined as cash, cash equivalents,
investments, and accounts receivable.
- Today we announced a non-dilutive
royalty monetization transaction with NovaQuest Capital Management,
providing $50 million to support our strategic priorities.
- After this transaction and based on
our latest forecast, we anticipate our 2022 ending cash balance to
be $380-$410 million.
_________________________
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 7,
2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss
financial results and provide a business update. A live audio
webcast of the call may be accessed in the investor section of the
Company’s website, 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 the 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 our
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
our product candidates, and our clinical programs. These
forward-looking statements include, but are not limited to,
statements about our plans, objectives, representations and
contentions and are not historical facts 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.
Our 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 our various
programs, including the enrollment and results from ongoing and
potential future clinical trials, and other matters that are
described in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2021 and our Quarterly Report on Form 10-Q for
the quarter ended September 30, 2022, 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 we undertake 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, 2022 |
|
|
December 31, 2021 |
|
(Unaudited) |
|
|
(1) |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
155,960 |
|
|
$ |
171,223 |
|
Short-term investments |
|
252,560 |
|
|
|
233,967 |
|
Accounts receivable, net |
|
15,328 |
|
|
|
17,401 |
|
Inventory |
|
39,950 |
|
|
|
31,015 |
|
Prepaid expenses and other current assets |
|
10,426 |
|
|
|
20,453 |
|
Total current assets |
|
474,224 |
|
|
|
474,059 |
|
|
|
|
|
|
Restricted time deposits |
|
2,072 |
|
|
|
2,072 |
|
Long-term investments |
|
17,780 |
|
|
|
167,796 |
|
Property and equipment,
net |
|
22,287 |
|
|
|
28,277 |
|
Equity method investment in
unconsolidated variable interest entity |
|
4,631 |
|
|
|
3,825 |
|
Operating lease right-of-use
assets |
|
82,903 |
|
|
|
91,112 |
|
Other assets |
|
4,940 |
|
|
|
6,680 |
|
Total assets |
$ |
608,837 |
|
|
$ |
773,821 |
|
|
|
|
|
|
Liabilities,
stockholders’ equity and non-controlling interests |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
19,323 |
|
|
$ |
26,097 |
|
Accrued and other liabilities |
|
213,806 |
|
|
|
172,599 |
|
Deferred revenue |
|
7,361 |
|
|
|
15,857 |
|
Operating lease liabilities, current |
|
11,504 |
|
|
|
10,944 |
|
Total current liabilities |
|
251,994 |
|
|
|
225,497 |
|
|
|
|
|
|
Product development
obligations |
|
15,422 |
|
|
|
17,613 |
|
Deferred revenue, net of
current |
|
199,758 |
|
|
|
186,801 |
|
Operating lease liabilities,
non-current |
|
81,091 |
|
|
|
88,776 |
|
Other long-term
liabilities |
|
14,299 |
|
|
|
26,021 |
|
Total liabilities |
|
562,564 |
|
|
|
544,708 |
|
|
|
|
|
|
Total stockholders’
equity |
|
26,306 |
|
|
|
209,146 |
|
Non-controlling interests |
|
19,967 |
|
|
|
19,967 |
|
Total equity |
|
46,273 |
|
|
|
229,113 |
|
Total liabilities,
stockholders’ equity and non-controlling interests |
$ |
608,837 |
|
|
$ |
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
— |
|
|
$ |
116,434 |
|
|
$ |
22,590 |
|
|
$ |
116,434 |
|
Development and other revenue |
|
2,453 |
|
|
|
26,097 |
|
|
|
19,672 |
|
|
|
60,325 |
|
Product revenue, net |
|
17,359 |
|
|
|
13,442 |
|
|
|
59,495 |
|
|
|
42,175 |
|
Drug product revenue |
|
(4,077 |
) |
|
|
— |
|
|
|
4,610 |
|
|
|
(168 |
) |
Total revenue |
|
15,735 |
|
|
|
155,973 |
|
|
|
106,367 |
|
|
|
218,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
4,308 |
|
|
|
3,266 |
|
|
|
15,355 |
|
|
|
9,746 |
|
Research and development |
|
75,182 |
|
|
|
75,880 |
|
|
|
235,163 |
|
|
|
273,123 |
|
Selling, general and administrative |
|
29,902 |
|
|
|
25,853 |
|
|
|
90,722 |
|
|
|
89,186 |
|
Total operating costs and expenses |
|
109,392 |
|
|
|
104,999 |
|
|
|
341,240 |
|
|
|
372,055 |
|
Income (loss) from
operations |
|
(93,657 |
) |
|
|
50,974 |
|
|
|
(234,873 |
) |
|
|
(153,289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other,
net: |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(84 |
) |
|
|
(109 |
) |
|
|
(321 |
) |
|
|
(965 |
) |
Interest income and other income (expenses), net |
|
1,798 |
|
|
|
(1,303 |
) |
|
|
6,672 |
|
|
|
(2,120 |
) |
Total interest and other, net |
|
1,714 |
|
|
|
(1,412 |
) |
|
|
6,351 |
|
|
|
(3,085 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before
income taxes |
|
(91,943 |
) |
|
|
49,562 |
|
|
|
(228,522 |
) |
|
|
(156,374 |
) |
Provision for income taxes |
|
114 |
|
|
|
106 |
|
|
|
250 |
|
|
|
235 |
|
Investment income in unconsolidated variable interest entity |
|
407 |
|
|
|
342 |
|
|
|
1,293 |
|
|
|
664 |
|
Net income
(loss) |
$ |
(91,650 |
) |
|
$ |
49,798 |
|
|
$ |
(227,479 |
) |
|
$ |
(155,945 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share -
basic and diluted |
$ |
(0.98 |
) |
|
$ |
0.54 |
|
|
$ |
(2.43 |
) |
|
$ |
(1.69 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares used to calculate net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
93,767 |
|
|
|
92,644 |
|
|
|
93,431 |
|
|
|
92,206 |
|
Diluted |
|
93,767 |
|
|
|
92,808 |
|
|
|
93,431 |
|
|
|
92,206 |
|
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
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