Fortress Biotech Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights
15 11월 2023 - 6:10AM
Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative
biopharmaceutical company focused on efficiently acquiring,
developing and commercializing or monetizing promising therapeutic
products and product candidates, today announced financial results
and recent corporate highlights for the third quarter ended
September 30, 2023.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman,
President and Chief Executive Officer, said, “In the third quarter
of 2023, Fortress and our partner companies and subsidiaries
continued to advance our diverse portfolio of drug candidates. Our
total consolidated net revenue this quarter was $34.8 million,
which includes an upfront payment of $19 million that Journey
Medical received upon entering into an exclusive license agreement
with Maruho for commercialization of Qbrexza® in additional
territories in Asia. We’re looking forward to multiple significant
near-term milestones, including potentially up to four New Drug
Application (“NDA”) and Biologics License Application (“BLA”)
submissions to the U.S. Food and Drug Administration (“FDA”)
between 2023 and 2025, one of which is a NDA for DFD-29 to treat
rosacea around the end of this year. We are also anticipating the
PDUFA goal date of January 3, 2024, for cosibelimab, our
investigational anti-PD-L1 antibody, as a treatment for patients
with metastatic or locally advanced cutaneous squamous cell
carcinoma (“cSCC”).”
Recent Corporate
Highlights2:
Marketed Dermatology
Products
- Journey Medical Corporation
(Nasdaq: DERM) (“Journey Medical”), our partner company, primarily
focuses on selling and marketing of prescription dermatology
products.
- In September 2023, Journey Medical
entered into an exclusive license agreement with Maruho Co., Ltd.
(“Maruho”), a Japanese company specializing in dermatology as well
as Journey’s exclusive licensing partner that developed and is
commercializing Qbrexza® (Rapifort®) in Japan. Under the terms of
the Agreement, Journey Medical received a $19 million nonrefundable
upfront payment and granted Maruho an exclusive license to develop
and commercialize Qbrexza (glycopyrronium tosylate hydrate) for the
treatment of hyperhidrosis in South Korea, Taiwan, Hong Kong,
Macau, Thailand, Indonesia, Malaysia, Philippines, Singapore,
Vietnam, Brunei, Cambodia, Myanmar and Laos (the “Territory”).
Maruho is responsible for all development and commercialization
costs for the program throughout the Territory.
- Journey Medical’s total net
revenues in the third quarter of 2023 were $34.5 million, an
increase of $18.4 million, or 114%, compared to total net revenues
of $16.1 million in the third quarter of 2022.
- Journey Medical’s total product net
revenues were $15.3 million for the third quarter of 2023, compared
to third quarter 2022 total product net revenues of $16.0
million.
Fortress, through its subsidiaries,
partner companies and partners, has a broad and diverse pipeline of
clinical-stage programs being evaluated in over 20 ongoing clinical
trials. We look forward to potential filings of up to four NDA and
BLA submissions from 2023 through 2025, including:
- DFD-29 – modified release oral
minocycline for rosacea
- Cosibelimab – anti-PD-L1 antibody
for solid tumors
- CUTX-101 – copper histidinate for
Menkes disease
- CAEL-101 – light chain
fibril-reactive monoclonal antibody for AL amyloidosis
We also expect to continue to advance
our early-to-mid-clinical-stage candidates, some of which may begin
pivotal trials during the next twelve to eighteen months,
including:
- Dotinurad – urate transporter
(URAT1) inhibitor for gout and hyperuricemia
- IV tramadol – intravenous small
molecule for acute post-operative pain
- MB-106 – CD20-targeted CAR-T cell
therapy for hematologic malignancies
- Triplex – multi-antigen, modified
vaccinia Ankara-based (MVA) vaccine for cytomegalovirus (CMV)
- MB-117 – ex vivo lentiviral gene
therapy for newborns with XSCID (X-linked severe combined
immunodeficiency)
- MB-217 – ex vivo lentiviral gene
therapy for previously transplanted children and young adults with
XSCID
- AJ201 – Nrf1 and Nrf2 activator, androgen receptor degradation
enhancer for spinal and bulbar muscular atrophy (SBMA), also known
as Kennedy’s Disease
- BAER-101 – GABAA α2/3 positive
allosteric modulator for refractory epilepsies
- MB-109 – IL13Rα2-targeted CAR-T cell therapy combined with
HSV-1 oncolytic virus for recurrent glioblastoma and high-grade
astrocytomas
General Corporate:
- In November 2023, Fortress raised
approximately $10.0 million in gross proceeds in a public
offering.
- In October 2023, Fortress effected
a 1-for-15 reverse stock split of its issued and outstanding common
stock to bring the Company into compliance with Nasdaq’s minimum
bid price requirement for continued listing.
Financial Results:
- As of September 30, 2023, Fortress’
consolidated cash, cash equivalents and restricted cash totaled
$74.7 million, compared to $89.2 million as of June 30, 2023, a
decrease of $14.5 million during the quarter.
- Fortress’ consolidated cash, cash
equivalents and restricted cash, totaling $74.7 million as of
September 30, 2023, includes $37.7 million attributable to Fortress
and private subsidiaries, $0.2 million attributable to Avenue, $1.8
million attributable to Checkpoint, $10.3 million attributable to
Mustang Bio and $24.7 million attributable to Journey Medical.
- Subsequent to the end of the third
quarter, in November 2023, Fortress raised approximately $10.0
million in gross proceeds in a public offering and Avenue raised
approximately $5.0 million in gross proceeds in a public offering.
In addition, in October 2023, Checkpoint raised approximately $11.1
million in gross proceeds from the exercise of warrants and Mustang
Bio raised approximately $4.4 million in gross proceeds in a
registered direct offering.
- Fortress’ consolidated net revenue
totaled $34.8 million for the third quarter of 2023, which included
$15.3 million in net product revenue generated from our marketed
dermatology products. This compares to consolidated net revenue
totaling $16.5 million for the third quarter of 2022, which
included $16.0 million in net product revenue generated from our
marketed dermatology products.
- Consolidated research and
development expenses including license acquisitions were $20.3
million for the third quarter of 2023, compared to $29.9 million
for the third quarter of 2022.
- Consolidated selling, general and
administrative expenses were $21.7 million for the third quarter of
2023, compared to $30.1 million for the third quarter of 2022.
- Consolidated net loss attributable
to common stockholders was $7.1 million, or $0.94 per share, for
the third quarter of 2023, compared to consolidated net loss
attributable to common stockholders of $24.5 million, or $4.11 per
share for the third quarter of 2022.
About Fortress Biotech Fortress
Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical
company focused on efficiently acquiring, developing and
commercializing or monetizing promising therapeutic products and
product candidates. The company has eight marketed prescription
pharmaceutical products and over 25 programs in development at
Fortress, at its majority-owned and majority-controlled partners
and subsidiaries and at partners and subsidiaries it founded and in
which it holds significant minority ownership positions. Such
product candidates span six large-market areas, including oncology,
rare diseases and gene therapy, which allow it to create value for
shareholders. Fortress advances its diversified pipeline through a
streamlined operating structure that fosters efficient drug
development. The Fortress model is focused on leveraging its
significant biopharmaceutical industry expertise and network to
further expand the company’s portfolio of product opportunities.
Fortress has established partnerships with some of the world’s
leading academic research institutions and biopharmaceutical
companies to maximize each opportunity to its full potential,
including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center,
St. Jude Children’s Research Hospital, Nationwide Children’s
Hospital and Sentynl. For more information, visit
www.fortressbiotech.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, as amended. As used
below and throughout this press release, the words “we”, “us” and
“our” may refer to Fortress individually or together with one or
more partner companies, as dictated by context. Such statements
include, but are not limited to, any statements relating to our
growth strategy and product development programs, ability to
generate shareholder value, ability of our products to receive
necessary approvals, including FDA approval, ability of our
products and therapies to help patients and any other statements
that are not historical facts. Forward-looking statements are based
on management’s current expectations and are subject to risks and
uncertainties that could negatively affect our business, operating
results, financial condition and stock price. Factors that could
cause actual results to differ materially from those currently
anticipated include, risks relating to: our growth strategy;
financing and strategic agreements and relationships; our need for
substantial additional funds and uncertainty relating to
financings; our ability to identify, acquire, close and integrate
product candidates successfully and on a timely basis; our ability
to attract, integrate and retain key personnel; the early stage of
products under development; the results of research and development
activities; uncertainties relating to preclinical and clinical
testing; risks relating to the timing of starting and completing
clinical trials; the ability to secure and maintain third-party
manufacturing, marketing and distribution of our and our partner
companies’ products and product candidates; government regulation;
patent and intellectual property matters; competition; as well as
other risks described in our SEC filings. We expressly disclaim any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in our expectations or any changes in events,
conditions or circumstances on which any such statement is based,
except as may be required by law, and we claim the protection of
the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. The information
contained herein is intended to be reviewed in its totality, and
any stipulations, conditions or provisos that apply to a given
piece of information in one part of this press release should be
read as applying mutatis mutandis to every other instance of such
information appearing herein.
Company Contact:Jaclyn JaffeFortress Biotech,
Inc.(781) 652-4500ir@fortressbiotech.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
FORTRESS BIOTECH, INC. AND
SUBSIDIARIESUnaudited Condensed Consolidated
Balance Sheets ($ in thousands except for share
and per share amounts)
|
September 30, |
|
December 31, |
|
2023 |
|
2022 |
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
72,307 |
|
|
$ |
178,266 |
|
Accounts receivable, net |
|
7,989 |
|
|
|
28,208 |
|
Inventory |
|
11,024 |
|
|
|
14,159 |
|
Other receivables - related party |
|
165 |
|
|
|
138 |
|
Prepaid expenses and other current assets |
|
6,341 |
|
|
|
9,661 |
|
Total current assets |
|
97,826 |
|
|
|
230,432 |
|
|
|
|
|
|
|
Property, plant and equipment,
net |
|
6,854 |
|
|
|
13,020 |
|
Operating lease right-of-use
asset, net |
|
17,507 |
|
|
|
19,991 |
|
Restricted cash |
|
2,438 |
|
|
|
2,688 |
|
Intangible asset, net |
|
21,102 |
|
|
|
27,197 |
|
Other assets |
|
4,822 |
|
|
|
973 |
|
Total
assets |
$ |
150,549 |
|
|
$ |
294,301 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
81,406 |
|
|
$ |
97,446 |
|
Income taxes payable |
|
84 |
|
|
|
— |
|
Common stock warrant liabilities |
|
5,430 |
|
|
|
13,869 |
|
Operating lease liabilities, short-term |
|
2,413 |
|
|
|
2,447 |
|
Partner company convertible preferred shares, short-term, net |
|
3,797 |
|
|
|
2,052 |
|
Partner company line of credit |
|
— |
|
|
|
2,948 |
|
Partner company installment payments - licenses, short-term,
net |
|
3,000 |
|
|
|
7,235 |
|
Other short-term liabilities |
|
1,221 |
|
|
|
1,718 |
|
Total current liabilities |
|
97,351 |
|
|
|
127,715 |
|
|
|
|
|
|
|
Notes payable, long-term,
net |
|
45,791 |
|
|
|
91,730 |
|
Operating lease liabilities,
long-term |
|
18,944 |
|
|
|
21,572 |
|
Partner company installment
payments - licenses, long-term, net |
|
— |
|
|
|
1,412 |
|
Other long-term
liabilities |
|
1,706 |
|
|
|
1,847 |
|
Total
liabilities |
|
163,792 |
|
|
|
244,276 |
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit) |
|
|
|
|
|
Cumulative redeemable perpetual preferred stock, $0.001 par value,
15,000,000 authorized, 5,000,000 designated Series A shares,
3,427,138 shares issued and outstanding as of
September 30, 2023 and December 31, 2022,
respectively, liquidation value of $25.00 per share |
|
3 |
|
|
|
3 |
|
Common
stock, $0.001 par value, 200,000,000 shares authorized, 8,937,587
and 7,366,283 shares issued and outstanding as of
September 30, 2023 and December 31, 2022,
respectively |
|
9 |
|
|
|
7 |
|
Additional paid-in-capital |
|
702,253 |
|
|
|
675,944 |
|
Accumulated deficit |
|
(685,591 |
) |
|
|
(634,233 |
) |
Total
stockholders' equity attributed to the Company |
|
16,674 |
|
|
|
41,721 |
|
|
|
|
|
|
|
Non-controlling interests |
|
(29,917 |
) |
|
|
8,304 |
|
Total
stockholders' equity (deficit) |
|
(13,243 |
) |
|
|
50,025 |
|
Total liabilities and stockholders' equity
(deficit) |
$ |
150,549 |
|
|
$ |
294,301 |
|
|
|
|
|
|
|
|
|
FORTRESS BIOTECH, INC. AND
SUBSIDIARIESUnaudited Condensed Consolidated
Statements of Operations($ in thousands except for
share and per share amounts)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue |
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
15,279 |
|
|
$ |
16,043 |
|
|
$ |
44,405 |
|
|
$ |
55,074 |
|
Collaboration revenue |
|
182 |
|
|
|
364 |
|
|
|
546 |
|
|
|
1,518 |
|
Revenue - related party |
|
31 |
|
|
|
48 |
|
|
|
97 |
|
|
|
118 |
|
Other revenue |
|
19,260 |
|
|
|
73 |
|
|
|
19,519 |
|
|
|
2,629 |
|
Net
revenue |
|
34,752 |
|
|
|
16,528 |
|
|
|
64,567 |
|
|
|
59,339 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold - product revenue |
|
6,429 |
|
|
|
7,221 |
|
|
|
20,645 |
|
|
|
23,057 |
|
Research and development |
|
20,288 |
|
|
|
29,855 |
|
|
|
87,702 |
|
|
|
99,707 |
|
Research and development - licenses acquired |
|
60 |
|
|
|
47 |
|
|
|
4,293 |
|
|
|
48 |
|
Selling, general and administrative |
|
21,733 |
|
|
|
30,139 |
|
|
|
71,512 |
|
|
|
85,457 |
|
Asset impairment |
|
— |
|
|
|
— |
|
|
|
3,143 |
|
|
|
— |
|
Total
operating expenses |
|
48,510 |
|
|
|
67,262 |
|
|
|
187,295 |
|
|
|
208,269 |
|
Loss
from operations |
|
(13,758 |
) |
|
|
(50,734 |
) |
|
|
(122,728 |
) |
|
|
(148,930 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
547 |
|
|
|
419 |
|
|
|
2,296 |
|
|
|
711 |
|
Interest expense and financing fee |
|
(2,534 |
) |
|
|
(3,393 |
) |
|
|
(13,255 |
) |
|
|
(8,897 |
) |
Change in fair value of warrant liabilities |
|
4,542 |
|
|
|
— |
|
|
|
10,708 |
|
|
|
— |
|
Other income |
|
620 |
|
|
|
648 |
|
|
|
(2,049 |
) |
|
|
648 |
|
Total
other income (expense) |
|
3,175 |
|
|
|
(2,326 |
) |
|
|
(2,300 |
) |
|
|
(7,538 |
) |
Loss
before income tax expense |
|
(10,583 |
) |
|
|
(53,060 |
) |
|
|
(125,028 |
) |
|
|
(156,468 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income
tax expense |
|
141 |
|
|
|
— |
|
|
|
142 |
|
|
|
— |
|
Net loss |
|
(10,724 |
) |
|
|
(53,060 |
) |
|
|
(125,170 |
) |
|
|
(156,468 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to non-controlling interests |
|
5,679 |
|
|
|
30,549 |
|
|
|
73,812 |
|
|
|
96,841 |
|
Net loss attributable to Fortress |
|
(5,045 |
) |
|
|
(22,511 |
) |
|
|
(51,358 |
) |
|
|
(59,627 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred A dividends declared and paid |
|
(2,008 |
) |
|
|
(2,008 |
) |
|
|
(6,024 |
) |
|
|
(6,024 |
) |
Net loss attributable to common stockholders |
$ |
(7,053 |
) |
|
$ |
(24,519 |
) |
|
$ |
(57,382 |
) |
|
$ |
(65,651 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per common share attributable to common stockholders - basic and
diluted |
$ |
(0.94 |
) |
|
$ |
(4.11 |
) |
|
$ |
(7.94 |
) |
|
$ |
(11.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding - basic and diluted |
|
7,498,653 |
|
|
|
5,961,663 |
|
|
|
7,231,004 |
|
|
|
5,886,131 |
|
_______________1 Includes CAEL-101, an asset in development at
Caelum Biosciences (a former subsidiary now 100% owned by
AstraZeneca’s Alexion) with respect to which Fortress remains
eligible to receive substantial milestone payments.2 The
development programs depicted in this press release include product
candidates in development at Fortress, at Fortress’ private
subsidiaries (referred to herein as “subsidiaries”), at Fortress’
public subsidiaries (referred to herein as “partner companies”) and
at entities with which one of the foregoing parties has a
significant business relationship, such as an exclusive license or
an ongoing product-related payment obligation (such entities
referred to herein as “partners”). The words “we”, “us” and “our”
may refer to Fortress individually, to one or more of our
subsidiaries and/or partner companies, or to all such entities as a
group, as dictated by context.
Fortress Biotech (NASDAQ:FBIO)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Fortress Biotech (NASDAQ:FBIO)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024