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 first quarter ended March
31, 2022.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman,
President and Chief Executive Officer, said, “Together with our
subsidiaries and partner companies, Fortress had an exciting start
to the year with the acquisition and commercial launch of two
dermatology products, Amzeeq® and Zilxi®, bringing our total number
of marketed prescription products to nine. Fortress also has a
growing portfolio of 30 product candidates across our partner
companies, including 20 separate clinical programs in 30 ongoing
clinical trials. Four product candidates are in seven1 ongoing
pivotal clinical trials. We were pleased to announce positive
topline results from the registration-enabling study of cosibelimab
in metastatic cutaneous squamous cell carcinoma (“cSCC”) in January
2022. Throughout the remainder of 2022 we anticipate multiple key
regulatory and clinical inflection points, such as the submission
of a Biologics License Application (“BLA”) to the U.S. Food and
Drug Administration (“FDA”) for cosibelimab and the completion of
Cyprium’s CUTX-101 rolling submission of its New Drug Application
(“NDA”). CUTX-101 is eligible for a priority review voucher upon
FDA approval. Moreover, we expect the availability of clinical data
from many product candidates in ongoing clinical trials including
MB-106, MB-107, cosibelimab and Dotinurad.”
Dr. Rosenwald continued, “We ended the first
quarter with $289.7 million in consolidated cash, cash equivalents
and restricted cash. Additionally, we attained a new company
quarterly record for net revenue, $23.9 million, which is an
increase of 106% period-over-period. We believe that we are
well-positioned for success with multiple product candidates and
remain focused on creating long-term shareholder value through
asset monetizations, equity holdings/appreciation in our
subsidiaries and partner companies, annual equity dividends and
royalty revenues.”
Recent Corporate
Highlights2:
Marketed Dermatology Products and
Product Candidates
- Journey Medical Corporation
(“Journey Medical”), a Fortress partner company, currently has nine
prescription dermatology products.
- Our products generated net revenues
of $20.8 million in the first quarter of 2022, compared to first
quarter 2021 net revenues of $10.7 million, representing growth of
94%.
- In March 2022, Journey Medical
dosed the first patient in the Phase 3 clinical program of DFD-29
for the treatment of papulopustular rosacea. Topline data are
anticipated in the first quarter of 2023 with an NDA filing
expected in the second half of 2023.
- In January 2022, Journey Medical
received notice from its exclusive licensing partner in Japan,
Maruho Co., Ltd., that Japan's Ministry of Health, Labor and
Welfare approved Rapifort® Wipes 2.5% (glycopyrronium tosylate
hydrate) for the treatment of primary axillary hyperhidrosis. This
approval triggered a milestone payment of $10.0 million to Journey
Medical, of which $7.5 million was paid to Dermira, Inc.
(“Dermira”), a wholly owned subsidiary of Eli Lilly and Company,
pursuant to the terms of the Asset Purchase Agreement between
Journey Medical and Dermira, with net proceeds of $2.5 million to
Journey Medical.
- Also in January 2022, Journey
Medical entered into a definitive agreement with VYNE Therapeutics,
Inc. to acquire two FDA-approved topical minocycline products,
Amzeeq® and Zilxi®, and a Molecule Stabilizing Technology™ platform
for an upfront payment of $20.0 million and an additional $5.0
million on the one (1)-year anniversary of the closing of the
transaction in January 2023.
- Additionally, in January 2022,
Journey Medical expanded the borrowing capacity of the East West
Bank credit agreement to $30.0 million, which includes an increase
to the working capital line of credit to $10.0 million and the
addition of a $20.0 million term loan.
- We intend to launch an additional
prescription product in the second half of 2022.
CUTX-101 (Copper Histidinate for Menkes
disease)
- In December 2021, we initiated the
rolling submission of an NDA to the FDA for CUTX-101. We intend to
complete the rolling submission of the NDA for CUTX-101 in
mid-2022.
- In March 2022, our subsidiary
company, Cyprium Therapeutics, Inc (“Cyprium”) announced positive
data on CUTX-101 were presented as a “Top-Rated Abstract” and
Poster at the 2022 American College of Medical Genetics and
Genomics Clinical Genetics Meeting. The abstract can be viewed
here.
- CUTX-101 is currently in
development at Cyprium.
CAEL-101 (Light Chain Fibril-reactive
Monoclonal Antibody for AL Amyloidosis)
- On October 5, 2021, AstraZeneca
acquired Caelum for an upfront payment of approximately $150
million paid to Caelum shareholders, of which approximately $56.9
million was paid to Fortress, net of Fortress’ $6.4 million portion
of the $15 million, 24-month escrow holdback amount and other
miscellaneous transaction expenses. The agreement also provides for
additional potential payments to Caelum shareholders totaling up to
$350 million, payable upon the achievement of regulatory and
commercial milestones. Fortress is eligible to receive 42.4% of all
potential milestone payments, totaling up to approximately $212
million.
- There are two ongoing Phase 3
studies of CAEL-101 for AL amyloidosis. (ClinicalTrials.gov
Identifiers: NCT04512235 and NCT04504825).
- CAEL-101 was sourced by Fortress
and was developed by Caelum until the acquisition by AstraZeneca in
October 2021.
Cosibelimab (formerly CK-301, an
anti-PD-L1 antibody)
- In January 2022, we announced
positive topline results from our registration-enabling clinical
trial evaluating the safety and efficacy of our anti-PD-L1
antibody, cosibelimab, administered as a fixed dose of 800 mg every
two weeks in patients with metastatic cSCC. The study met its
primary endpoint, with cosibelimab demonstrating a confirmed
objective response rate of 47.4% (95% CI: 36.0, 59.1) based on
independent central review of 78 patients enrolled in the
metastatic cSCC cohort using Response Evaluation Criteria in Solid
Tumors version 1.1 criteria. Our partner company, Checkpoint
Therapeutics, Inc. (“Checkpoint”) intends to submit a BLA for
cosibelimab in 2022, followed by a Marketing Authorization
Application submission in Europe and other territories worldwide.
With a potentially favorable safety profile versus anti-PD-1
therapy and a plan to commercialize at a substantially lower price,
we believe cosibelimab has the potential to be a market disruptive
product in the $30 billion and growing PD-(L)1 class.
- In April 2022, we announced that
the results of our pivotal trial of cosibelimab in cSCC were
selected for poster presentation at the 2022 American Society of
Clinical Oncology Annual Meeting, to be held at McCormick Place, in
Chicago, June 3-7, 2022.
- Cosibelimab was sourced by Fortress
and is currently in development at Checkpoint.
MB-106 (CD20-targeted CAR T Cell
Therapy)
- In April 2022, we announced that
interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T
cell therapy for patients with relapsed or refractory B-cell
non-Hodgkin lymphomas (“NHL”) and chronic lymphocytic leukemia
(“CLL”), were presented at the 2022 Tandem Meetings I
Transplantation & Cellular Therapy Meetings of the American
Society of Transplantation and Cellular Therapy and Center for
International Blood & Marrow Transplant Research. Data
demonstrated high efficacy and a very favorable safety profile in
all patients (n=25). Five dose levels were used during the study,
and complete responses were observed at all dose levels. Durable
responses were observed in a wide range of hematologic malignancies
including follicular lymphoma (“FL”), CLL, diffuse large B-cell
lymphoma (“DLBCL”), and Waldenstrom macroglobulinemia (“WM”). An
overall response rate (“ORR”) of 96% and complete response (“CR”)
rate of 72% was observed in all patients across all dose levels.
Additionally, two patients had been previously treated with
CD19-directed CAR T therapy and subsequently relapsed, and both
responded to treatment, one patient with FL with a CR and the other
with DLBCL with a partial response. We expect to dose the first
patient in a Mustang-sponsored multicenter Phase 1/2 clinical trial
evaluating the safety and efficacy of MB-106 for relapsed or
refractory B-NHL and CLL in the second quarter of this year. A copy
of the abstract can be viewed on the meeting website here.
- Also in April 2022, MB-106 data
focused on CLL were presented at the 4th International Workshop on
CAR-T and Immunotherapies.
- In May 2022, we announced that
MB-106 CD20-targeted CAR T therapy data were selected for an oral
presentation at the European Hematology Association 2022
(“EHA2022”) Hybrid Congress scheduled to take place in June. Dr.
Mazyar Shadman of Fred Hutch will present updated interim data from
the ongoing Phase 1/2 clinical trial for B-NHL and CLL. A copy of
the abstract can be viewed online through the EHA2022 website
here.
- MB-106 was sourced by Fortress and
is currently in development at our partner company, Mustang Bio,
Inc. (“Mustang Bio”).
MB-107 and MB-207 (Lentiviral Gene
Therapies for XSCID)
- In May 2022, we announced that
interim Phase 1/2 data on treatment with the same lentiviral vector
used in MB-107, Mustang Bio’s lentiviral gene therapy for X-linked
severe combined immunodeficiency (“XSCID”), also known as bubble
boy disease, in newly diagnosed infants under the age of two, were
selected for an oral presentation during the Clinical Trials
Spotlight Symposium at the American Society of Gene & Cell
Therapy 25th Annual Meeting taking place May 16-19, 2022, both
virtually and in Washington, D.C. The presentation will include
updated data from a multicenter Phase 1/2 clinical trial for XSCID
in newly diagnosed infants under the age of two at St. Jude
Children’s Research Hospital, UCSF Benioff Children’s Hospital in
San Francisco and Seattle Children’s Hospital. The abstract can be
viewed on the meeting website here. Information on such website is
not part of this release.
- In the second half of 2022, we
expect to enroll the first patient in a pivotal multicenter Phase 2
clinical trial under Mustang Bio’s Investigational New Product Drug
Application (“IND”) to evaluate MB-107, a lentiviral gene therapy
for the treatment of infants under the age of two with XSCID.
- Mustang Bio filed an IND
application in December 2021 for its pivotal multicenter Phase 2
clinical trial of MB-207, a lentiviral gene therapy for the
treatment of patients with XSCID who have been previously treated
with a hematopoietic stem cell transplantation and for whom
re-treatment is indicated. The trial is currently on hold pending
CMC clearance from the FDA, and based on feedback from the Agency,
Mustang Bio expects to enroll the first patient in a pivotal
multicenter Phase 2 clinical trial in the first quarter of
2023.
- MB-107 and MB-207 were sourced by
Fortress and are currently in development at Mustang Bio.
Dotinurad (Urate Transporter (URAT1)
Inhibitor)
- In May 2021, we announced an
exclusive license agreement with Fuji Yakuhin Co. Ltd. to develop
Dotinurad in North America and Europe. Dotinurad is a potential
best-in-class urate transporter (URAT1) inhibitor for gout and
possibly other hyperuricemic indications including chronic kidney
disease (CKD) and heart failure. Dotinurad (URECE® tablet) was
approved in Japan in 2020 as a once-daily oral therapy for gout and
hyperuricemia. Dotinurad was efficacious and well-tolerated in more
than 500 Japanese patients treated for up to 58 weeks in Phase 3
clinical trials. Over 1,000 Japanese patients have been treated
safely with this drug.
- In December 2021, we filed an IND
with the FDA. We expect to initiate a Phase 1 clinical trial to
evaluate Dotinurad for the treatment of gout in the first half of
2022. We anticipate topline data from the Phase 1 trial in the
second half of 2022.
- Dotinurad was sourced by Fortress
and is currently in development at our subsidiary company, UR-1
Therapeutics.
MB-105 (PSCA-targeted CAR T Cell
Therapy)
- In February 2022, Phase 1 data on
MB-105, a prostate stem cell antigen (“PSCA”)-targeted CAR T cell
therapy administered systemically to patients with PSCA-positive
metastatic castration-resistant prostate cancer (“mCRPC”), were
presented by City of Hope at the 2022 American Society of Clinical
Oncology Genitourinary Cancers Symposium. The data indicated that
PSCA-targeted CAR T-cell therapy is feasible in patients with mCRPC
with dose-limiting toxicity of cystitis and is associated with
preliminary anti-tumor effect at a dose of 100 million cells plus
lymphodepletion. It was concluded that escalation up to the next
dose level of 300 million cells plus modified lymphodepletion can
proceed in the trial.
- MB-105 was sourced by Fortress and
is currently in development at Mustang Bio.
MB-109 (MB-101 (IL13Rα2-targeted CAR T
Cell Therapy) + MB-108 Oncolytic Virus)
- In April 2022, we announced our
plan to file an IND in the second half of 2022 to initiate a Phase
1 clinical trial combining CAR T cells and an oncolytic virus for
the treatment of recurrent glioblastoma (“rGBM”), supported by
interim data from two ongoing investigator-sponsored Phase 1
clinical trials evaluating two clinical candidates, MB‐101
(IL13Rα2‐targeted CAR T cell therapy licensed from City of Hope)
and MB-108 (C134 oncolytic virus licensed from Nationwide
Children’s Hospital). The data are from a late-breaking poster
presented at the American Association for Cancer Research Annual
Meeting 2022. Preclinical data also presented support the safety of
administering these two therapies sequentially to optimize
treatment in a regimen designated as MB-109.
- MB-101 and MB-108 were sourced by
Fortress and they are currently in development at Mustang Bio.
General Corporate
- In April 2022, Fortress
participated in a two-day summit hosted by the B. Riley Securities’
Healthcare Equity Research team that featured multiple programs
from Fortress’ diversified pipeline. Webcast replays are available
on Fortress’ website here.
Financial Results:
To assist our stockholders in understanding our
company, we have prepared non-GAAP financial results for the three
months ended March 31, 2022 and 2021. These results exclude the
operations of our four public partner companies: Avenue
Therapeutics, Inc. (“Avenue”), Checkpoint, Journey Medical and
Mustang Bio, as well as any one-time, non-recurring, non-cash
transactions. The goal in providing these non-GAAP financial
metrics is to highlight the financial results of Fortress’ core
operations, which are comprised of our privately held
development-stage entities, as well as our business development and
finance functions. See “Use of Non-GAAP Measures” below.
- As of March 31, 2022, Fortress’
consolidated cash, cash equivalents and restricted cash totaled
$289.7 million, compared to $308.0 million as of December 31, 2021,
a decrease of $18.3 million during the quarter.
- On a GAAP basis, Fortress’ net
revenue totaled $23.9 million for the first quarter of 2022, which
included $20.8 million in net revenue generated from our marketed
dermatology products. This compares to net revenue totaling $11.6
million for the first quarter of 2021, which included $10.7 million
in net revenue generated from our marketed dermatology
products.
- On a GAAP basis, consolidated
research and development expenses including license acquisitions
were $36.7 million for the first quarter of 2022, compared to $20.2
million for the first quarter of 2021. On a non-GAAP basis,
Fortress research and development expenses were $2.8 million for
the first quarter of 2022, compared to $4.1 million for first
quarter of 2021.
- On a GAAP basis, consolidated
selling, general and administrative expenses were $26.3 million for
the first quarter of 2022, compared to $17.5 million for the first
quarter of 2021. On a non-GAAP basis, Fortress selling, general and
administrative expenses were $6.2 million, for the first quarter of
2022, compared to $6.7 million for the first quarter of 2021.
- On a GAAP basis, consolidated net
loss attributable to common stockholders was $15.8 million, or
$0.18 per share, for the first quarter of 2022, compared to
consolidated net loss attributable to common stockholders of $8.8
million, or $0.11 per share for the first quarter of 2021.
- Fortress’ non-GAAP loss
attributable to common stockholders was $5.7 million, or $0.07 per
share, for the first quarter of 2022, compared to Fortress’
non-GAAP loss attributable to common stockholders of $8.5 million,
or $0.11 per share, for the first quarter of 2021.
Use of Non-GAAP Measures:
In addition to the GAAP financial measures as
presented in this press release and that will be presented in our
Form 10-Q to be filed with the Securities and Exchange Commission
(“SEC”) on May 12, 2022, the Company, in this press release, has
included certain non-GAAP measurements. The non-GAAP net loss
attributable to common stockholders is defined by the Company as
GAAP net loss attributable to common stockholders, less net losses
attributable to common stockholders from our public partner
companies Avenue, Checkpoint, Journey Medical and Mustang Bio
(“public partner companies”), as well as our former subsidiary,
Caelum. In addition, the Company has also provided a Fortress
non-GAAP loss attributable to common stockholders which is a
modified EBITDA calculation that starts with the non-GAAP loss
attributable to common stockholders and removes stock-based
compensation expense, non-cash interest expense, amortization of
licenses and debt discount, changes in fair values of investment,
changes in fair value of derivative liability, and depreciation
expense. The Company also provides non-GAAP research and
development expenses including license acquisitions, defined as
GAAP research and development costs, less research and development
costs of our public partner companies and non-GAAP consolidated
selling, general and administrative expenses, defined as GAAP
selling, general and administrative expenses, less selling, general
and administrative costs of our public partner companies.
Management believes each of these non-GAAP
measures provide meaningful supplemental information regarding the
Company's performance because (i) it allows for greater
transparency with respect to key measures used by management in its
financial and operational decision-making; (ii) it excludes the
impact of non-cash or, when specified, non-recurring items that are
not directly attributable to the Company's core operating
performance and that may obscure trends in the Company's core
operating performance; and (iii) it is used by institutional
investors and the analyst community to help analyze the Company's
standalone results separate from the results of its public partner
companies. However, non-GAAP loss attributable to common
stockholders and any other non-GAAP financial measures should be
considered as a supplement to, and not as a substitute for, or
superior to, the corresponding measures calculated in accordance
with GAAP. Further, non-GAAP financial measures used by the Company
and the manner in which they are calculated may differ from the
non-GAAP financial measures or the calculations of the same
non-GAAP financial measures used by other companies, including the
Company's competitors.
The tables below provide a reconciliation from
GAAP to non-GAAP measures:
|
|
|
|
|
|
|
|
|
|
For the three months ended March
31, |
|
($ in thousands except for share and per share
amounts) |
|
|
2022 |
|
20211 |
|
Net loss attributable to common
stockholders |
|
|
$ |
(15,760 |
) |
$ |
(8,822 |
) |
Net loss attributable to common stockholders - Avenue2 |
|
|
(535 |
) |
(225 |
) |
Net loss attributable to common stockholders - Checkpoint3 |
|
|
(2,924 |
) |
(1,158 |
) |
Net (loss) income attributable to common stockholders - Journey
Medical4 |
|
|
(817 |
) |
233 |
|
Net loss attributable to common stockholders - Mustang Bio5 |
|
|
(2,541 |
) |
(2,773 |
) |
Non-GAAP loss attributable to common
stockholders |
|
|
$ |
(8,943 |
) |
$ |
(4,899 |
) |
Stock based compensation |
|
|
2,782 |
|
1,866 |
|
Amortization of debt discount |
|
|
357 |
|
309 |
|
Depreciation |
|
|
100 |
|
141 |
|
Increase in fair value of investment in Caelum |
|
|
- |
|
(5,913 |
) |
Fortress non-GAAP loss attributable to common
stockholders |
|
|
$ |
(5,705 |
) |
$ |
(8,496 |
) |
|
|
|
|
|
|
|
Per common share - basic and diluted: |
|
|
|
|
|
|
Net loss attributable to common stockholders (GAAP) |
|
|
$ |
(0.18 |
) |
$ |
(0.11 |
) |
Non-GAAP net loss attributable to common stockholders |
|
|
$ |
(0.10 |
) |
$ |
(0.06 |
) |
Fortress non-GAAP loss attributable to common stockholders |
|
|
$ |
(0.07 |
) |
$ |
(0.11 |
) |
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted |
|
|
86,255,142 |
|
80,851,671 |
|
|
|
|
|
|
|
|
- Results for the
three months ended March 31, 2021 have been adjusted to present
Journey Medical separately as a public entity.
- Avenue net loss
for the three months ended March 31, 2022 and 2021 of $2.9 million
and $1.0 million, respectively, net of non-controlling interest of
$2.4 million and $0.8 million, respectively.
- Checkpoint net
loss of $16.8 million net of non-controlling interest of $13.6
million, Fortress MSA fee of $0.1 million, and Fortress financing
fee of $0.2 million for the three months ended March 31, 2022; and
net loss of $6.5 million net of non-controlling interest of $4.6
million, Fortress MSA fee of $0.1 million, and Fortress financing
fee of $0.6 million for the three months ended March 31, 2021.
- Journey Medical
net loss for the three months ended March 31, 2022 of $1.4 million
net of non-controlling interest of $0.5 million and tax expense
recognized on a stand-alone basis of $0.1 million; and net income
for the three months ended March 31, 2021 of $0.3 million, net
non-controlling interest of approximately $35,000.
- Mustang Bio net
loss of $19.8 million net of non-controlling interest of $16.2
million, Fortress MSA fee of $0.3 million and Fortress financing
fee of $0.8 million for the three months ended March 31, 2022; and
net loss of $15.0 million net of non-controlling interest of $10.9
million, Fortress MSA fee of $0.1 million and Fortress financing
fee of $1.2 million for the three months ended March 31, 2021.
Reconciliation to non-GAAP research and
development and general and administrative costs:
|
|
|
|
|
|
|
|
|
|
|
For the three months ended March 31, |
($ in thousands) |
2022 |
|
|
20211 |
Research and development1 |
$ |
36,722 |
|
|
$ |
20,154 |
Less: |
|
|
|
|
Research and development -
Avenue |
1,808 |
|
|
258 |
Research and development -
Checkpoint |
14,670 |
|
|
4,213 |
Research and development -
Journey Medical |
1,266 |
|
|
- |
Research and development -
Mustang Bio2 |
16,164 |
|
|
11,556 |
Non-GAAP research and
development costs |
$ |
2,814 |
|
|
$ |
4,127 |
|
|
|
|
|
Selling, general and
administrative |
$ |
26,270 |
|
|
$ |
17,542 |
Less: |
|
|
|
|
General and administrative -
Avenue |
1,055 |
|
|
743 |
General and administrative -
Checkpoint3 |
1,922 |
|
|
1,615 |
Selling, general and
administrative - Journey Medical |
14,715 |
|
|
6,226 |
General and administrative -
Mustang Bio4 |
2,402 |
|
|
2,210 |
Non-GAAP selling,
general and administrative costs |
$ |
6,177 |
|
|
$ |
6,748 |
|
|
|
|
|
- Includes Research and development
expense and Research and development - licenses acquired expense
for the three months ended March 31, 2021.
- Excludes $0.1 million of Fortress
MSA expense for each of the three months ended March 31, 2022 and
2021.
- Excludes $0.1 million of Fortress
MSA expense and $0.2 million Fortress financing fee for the three
months ended March 31, 2022; and $0.1 million of Fortress MSA
expense and $0.6 million Fortress financing fee for the three
months ended March 31, 2021.
- Excludes $0.1 million of Fortress
MSA expense and $0.8 million Fortress financing fee for the three
months ended March 31, 2022; and $0.1 million of Fortress MSA
expense and $1.2 million Fortress financing fee for the three
months ended March 31, 2021.
About Fortress Biotech Fortress
Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical
company focused on acquiring, developing and commercializing
high-potential marketed and development-stage drugs and drug
candidates. The company has nine marketed prescription
pharmaceutical products and over 30 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 driven by a world-class business
development team that is focused on leveraging its significant
biopharmaceutical industry expertise 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 plc,
City of Hope, Fred Hutchinson Cancer Research Center, St. Jude
Children’s Research Hospital, Nationwide Children’s Hospital and
Sentynl Therapeutics, Inc. 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, 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; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to 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, including
disruptions that may result from hostilities in Europe; our
dependence on third-party suppliers; risks relating to the COVID-19
outbreak and its potential impact on our employees’ and
consultants’ ability to complete work in a timely manner and on our
ability to obtain additional financing on favorable terms or at
all; our ability to attract, integrate and retain key personnel;
the early stage of products under development; our need for
substantial additional funds; 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.
Company Contacts:Jaclyn Jaffe and Bill
BegienFortress 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)
|
March 31, |
|
|
December 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash
and cash equivalents |
$ |
287,511 |
|
|
$ |
305,744 |
|
Accounts receivable, net |
|
31,183 |
|
|
|
23,112 |
|
Inventory |
|
16,137 |
|
|
|
9,862 |
|
Other
receivables - related party |
|
631 |
|
|
|
678 |
|
Prepaid expenses and other current assets |
|
5,724 |
|
|
|
7,066 |
|
Total current assets |
|
341,186 |
|
|
|
346,462 |
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
14,430 |
|
|
|
15,066 |
|
Operating lease right-of-use asset, net |
|
18,565 |
|
|
|
19,005 |
|
Restricted cash |
|
2,220 |
|
|
|
2,220 |
|
Intangible asset, net |
|
30,457 |
|
|
|
12,552 |
|
Other
assets |
|
1,072 |
|
|
|
1,198 |
|
Total assets |
$ |
407,930 |
|
|
$ |
396,503 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
91,268 |
|
|
$ |
90,660 |
|
Deferred revenue |
|
2,034 |
|
|
|
2,611 |
|
Income taxes payable |
|
346 |
|
|
|
345 |
|
Operating lease liabilities, short-term |
|
2,129 |
|
|
|
2,104 |
|
Partner company line of credit |
|
— |
|
|
|
812 |
|
Partner company installment payments - licenses, short-term (net of
imputed interest of $637 and $490 as of March 31, 2022 and
December 31, 2021, respectively) |
|
7,363 |
|
|
|
4,510 |
|
Total current liabilities |
|
103,140 |
|
|
|
101,042 |
|
|
|
|
|
|
|
|
|
Notes
payable, long-term (net of debt discount of $10,994 and $7,063 as
of March 31, 2022 and December 31, 2021,
respectively) |
|
85,056 |
|
|
|
42,937 |
|
Operating lease liabilities, long-term |
|
20,454 |
|
|
|
20,987 |
|
Partner company installment payments - licenses, long-term (net of
imputed interest of $284 and $373 as of March 31, 2022 and
December 31, 2021, respectively) |
|
3,716 |
|
|
|
3,627 |
|
Other
long-term liabilities |
|
1,986 |
|
|
|
2,033 |
|
Total liabilities |
|
214,352 |
|
|
|
170,626 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Cumulative redeemable perpetual preferred stock, $.001 par value,
15,000,000 authorized, 5,000,000 designated Series A shares,
3,427,138 shares issued and outstanding as of
March 31, 2022 and December 31, 2021,
respectively, liquidation value of $25.00 per share |
|
3 |
|
|
|
3 |
|
Common stock, $.001 par value, 170,000,000 shares authorized,
106,321,875 and 101,435,505 shares issued and outstanding as of
March 31, 2022 and December 31, 2021,
respectively |
|
106 |
|
|
|
101 |
|
Additional paid-in-capital |
|
660,973 |
|
|
|
656,033 |
|
Accumulated deficit |
|
(563,223 |
) |
|
|
(547,463 |
) |
Total
stockholders' equity attributed to the Company |
|
97,859 |
|
|
|
108,674 |
|
|
|
|
|
|
|
|
|
Non-controlling interests |
|
95,719 |
|
|
|
117,203 |
|
Total
stockholders' equity |
|
193,578 |
|
|
|
225,877 |
|
Total liabilities and stockholders' equity |
$ |
407,930 |
|
|
$ |
396,503 |
|
|
|
|
|
|
|
|
|
|
FORTRESS BIOTECH, INC. AND SUBSIDIARIES |
Unaudited Condensed Consolidated Statements of
Operations |
($ in thousands except for share and per share
amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
2021 |
|
Revenue |
|
|
|
|
|
|
|
Product revenue, net |
$ |
20,796 |
|
|
$ |
10,719 |
|
Collaboration revenue |
|
577 |
|
|
|
800 |
|
Revenue - related party |
|
52 |
|
|
|
68 |
|
Other revenue |
|
2,500 |
|
|
|
— |
|
Net revenue |
|
23,925 |
|
|
|
11,587 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of goods sold - product
revenue |
|
8,203 |
|
|
|
3,908 |
|
Research and development |
|
36,722 |
|
|
|
20,028 |
|
Research and development -
licenses acquired |
|
— |
|
|
|
126 |
|
Selling, general and
administrative |
|
26,270 |
|
|
|
17,542 |
|
Total operating expenses |
|
71,195 |
|
|
|
41,604 |
|
Loss from operations |
|
(47,270 |
) |
|
|
(30,017 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
Interest income |
|
142 |
|
|
|
227 |
|
Interest expense and financing
fee |
|
(2,350 |
) |
|
|
(2,189 |
) |
Change in fair value of
investments |
|
— |
|
|
|
5,913 |
|
Total other income
(expense) |
|
(2,208 |
) |
|
|
3,951 |
|
Net loss |
|
(49,478 |
) |
|
|
(26,066 |
) |
|
|
|
|
|
|
|
|
Net loss attributable to
non-controlling interests |
|
33,718 |
|
|
|
17,244 |
|
Net loss attributable
to common stockholders |
$ |
(15,760 |
) |
|
$ |
(8,822 |
) |
|
|
|
|
|
|
|
|
Net loss per common share -
basic and diluted |
$ |
(0.57 |
) |
|
$ |
(0.32 |
) |
Net loss per common share
attributable to non - controlling interests - basic and
diluted |
$ |
(0.39 |
) |
|
$ |
(0.21 |
) |
Net loss per common share
attributable to common stockholders - basic and diluted |
$ |
(0.18 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding - basic and diluted |
|
86,255,142 |
|
|
|
80,851,671 |
|
|
|
|
|
|
|
|
|
_________________________________
1 Includes two trials at our partner company Caelum Biosciences,
Inc. (“Caelum”) which was sold to AstraZeneca PLC as
successor-in-interest to Alexion Pharmaceuticals, Inc. in October
2021. Fortress remains eligible to receive up to approximately $155
million in future milestone payments from the transaction.2
Includes product candidates in development at Fortress,
majority-owned and controlled partners and/or subsidiaries, and
partners and/or subsidiaries in which Fortress holds significant
minority ownership positions. As used herein, the words “we”, “us”
and “our” may refer to Fortress individually or together with our
affiliates, subsidiaries, and partners, and the word “partner”
refers to either entities that are publicly traded and in which we
own or control a majority of the ownership position or third party
entities with whom we have a significant business relationship,
each as dictated by context.
Fortress Biotech (NASDAQ:FBIO)
Historical Stock Chart
From Apr 2024 to May 2024
Fortress Biotech (NASDAQ:FBIO)
Historical Stock Chart
From May 2023 to May 2024