Total net revenue increased 14% to $18.7 million for second quarter of 2026 compared to second quarter of 2025
Partnered programs continue to advance with Crystalys Therapeutics announcing its $130 million Series B financing to support the late-stage global development and commercialization preparation for dotinurad, and royalties generated from the launches of ZYCUBO$(R)$ and UNLOXCYT$(TM)$
MIAMI, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2026.
Lindsay A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "The second quarter of 2026 reflected continued momentum across our portfolio and further progress in unlocking long-term shareholder value. Our subsidiary Urica Therapeutics, Inc.'s ("Urica") equity position in Crystalys Therapeutics, Inc. ("Crystalys") was strengthened by Crystalys' $130 million Series B financing, which will support the late-stage global development and commercialization preparation for dotinurad, a next-generation oral URAT1 inhibitor for gout, on which Urica is entitled to a 3% royalty on future net sales. Journey Medical also continues to scale Emrosi(R) , securing a third major GPO contract that expanded payer access to over 150 million commercial lives. Coming off the momentum of ZYCUBO(R) 's approval and the $205 million PRV sale in the first quarter, we enter the second half of 2026 with a favorable cash balance that positions us to continue executing on our pipeline and business development priorities."
Dr. Rosenwald added, "We continued to see encouraging clinical progress this quarter on our partnered programs. AstraZeneca reported additional prespecified subgroup analyses for anselamimab (formerly CAEL-101) showing a 62% improvement in survival and a 71% reduction in cardiovascular hospitalizations among kappa predominant light chain isotype patients in the CARES program, and indicated that it plans to submit these findings to regulatory authorities. Crystalys also continues to advance dotinurad's two global Phase 3 trials while initiating a new Phase 2 study in difficult-to-treat gout, broadening the program's potential patient population. With a diversified portfolio spanning commercial, late-stage, and development-stage programs, including royalties, milestones and equity, and a strengthened balance sheet following the ZYCUBO(R) PRV monetization, we believe Fortress is well positioned to advance strategic initiatives and drive long-term value for our shareholders."
Recent Corporate Highlights(1) :
Commercial Portfolio Updates
-- Journey Medical Expands Payer Access for Emrosi(R). At the end of March
2025, our partner company Journey Medical Corporation ("Journey Medical")
commercially launched Emrosi(R) (40mg Minocycline Hydrochloride
Modified-Release Capsules, consisting of 10mg immediate release and 30mg
extended release pellets), also known as DFD-29, for inflammatory lesions
of rosacea. Emrosi(R) was approved by the FDA in November 2024 and is
available by prescription at specialty pharmacy chains. In April 2026,
Journey Medical announced that it secured a contract with a third major
group purchasing organization (GPO) for Emrosi(R). As such, payer access
for Emrosi(R) expanded to over 150 million commercial lives as of April
1, 2026, which equates to approximately 85% of all commercial lives in
the United States that have access to Emrosi(R). Journey Medical reported
net product revenues of $17.8 million for the second quarter of 2026,
compared to net product revenues of $15.0 million for the second quarter
ended June 30, 2025.
-- Royalties. In the second quarter of 2026, Cyprium Therapeutics, Inc.
("Cyprium") recognized $0.2 million in royalty revenue on net sales of
ZYCUBO(R), and Fortress recognized $0.1 million in royalty income
(contingent consideration) on net sales of UNLOXCYT(TM), following their
recent commercial launches.
Clinical Updates
-- Phase 3 CARES Results for Anselamimab (CAEL-101); Regulatory Submission
of Prespecified Subgroup Analysis Planned. In the second quarter of 2026,
AstraZeneca announced additional prespecified subgroup analyses in
patients with kappa predominant light chain isotype, showing that
anselamimab (formerly known as CAEL-101) improved survival by 62%,
measured by time to all-cause mortality (HR 0.38; 95% CI 0.17, 0.86;
nominal p=0.012), and reduced the frequency of cardiovascular
hospitalizations by 71% (incidence risk ratio 0.29; 95% CI 0.10, 0.87;
nominal p=0.028) compared to placebo in the subgroup with kappa AL
amyloidosis. Although anselamimab did not achieve statistical
significance for the primary endpoint in its Phase III Cardiac Amyloid
Reaching for Extended Survival ("CARES") clinical program for Mayo stages
IIIa and IIIb AL amyloidosis patients, the drug showed clinically
meaningful improvement in the prespecified subgroup and was well
tolerated. AstraZeneca indicated that the company plans to submit the
prespecified subgroup analysis from the CARES trials to regulatory
authorities and disclosed regulatory submissions in the EU and Japan.
-- Dotinurad Progresses in Phase 3 Development with Crystalys Series B
Financing of $130 million; Initiation of Phase 2 Clinical Trial for
Difficult-to-Treat Gout. In July 2026, Crystalys, in which our
majority-owned and controlled subsidiary company Urica maintains an
equity position, announced a $130 million Series B financing to support
the late-stage global clinical development and commercialization
preparation for dotinurad. Patients continue to be enrolled in Crystalys'
two randomized, double-blind, multicenter global Phase 3 trials
evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor
with potential for best-in-class safety and efficacy for the treatment of
gout. In the second quarter of 2026, Crystalys also announced the
initiation of a Phase 2 study in difficult-to-treat gout.
-- Other Portfolio Programs Continue to Advance with Potential Upcoming Data
and Trial Initiations. Triplex is currently in multiple ongoing clinical
trials for cytomegalovirus (CMV) treatment and prevention in solid organ
and stem cell transplants, combination trials with CAR T cell therapies
for hematologic malignancies, and a potential data readout by the end of
2026 for prevention and control of CMV in patients co-infected with HIV
and CMV. A clinical trial evaluating MB-109, a combination CAR T cell
therapy and oncolytic virus, is anticipated to initiate in the fourth
quarter of 2026 for patients with IL13R<ALPHA>2-positive recurrent
glioblastoma and high-grade astrocytoma. There are also ongoing and
planned regulatory interactions with the FDA on trial designs for ATX-04
(selective <BETA>2-adrenergic agonist) for patients with Pompe disease
and FB-606 (membrane stabilizer) for patients with Duchenne muscular
dystrophy.
Financial Results:
-- As of June 30, 2026, Fortress' consolidated cash and cash equivalents
totaled $196.6 million, compared to $79.4 million as of December 31,
2025, an increase of $117.2 million year-to-date.
-- Fortress' consolidated cash and cash equivalents totaling $196.6 million
as of June 30, 2026, includes $153.8 million attributable to Fortress and
the private subsidiaries, $1.9 million attributable to Avenue, $15.1
million attributable to Mustang Bio and $25.6 million attributable to
Journey Medical.
-- Fortress' consolidated cash and cash equivalents totaled $79.4
million as of December 31, 2025, and includes $35.2 million
attributable to Fortress and private subsidiaries, $2.9 million
attributable to Avenue, $17.3 million attributable to Mustang and
$24.1 million attributable to Journey Medical.
-- Fortress' consolidated net revenue totaled $18.7 million for the second
quarter ended June 30, 2026, $17.8 million of which was generated from
our marketed dermatology products. This compares to consolidated net
revenue totaling $16.4 million for the second quarter of 2025, $15.0
million of which was generated from our marketed dermatology products.
-- Consolidated research and development expenses totaled $0.8 million for
the second quarter ended June 30, 2026, compared to $8.1 million for the
second quarter ended June 30, 2025.
-- Consolidated selling, general and administrative costs were $20.8 million
for the second quarter ended June 30, 2026, compared to $38.8 million for
the second quarter ended June 30, 2025.
-- Consolidated net loss attributable to common stockholders was $(2.5)
million, or $(0.08) per share basic and diluted, for the second quarter
ended June 30, 2026, compared to net income attributable to common
stockholders of $13.4 million, or $0.50 per share basic, and $0.45 per
share diluted, for the second quarter ended June 30, 2025.
About Fortress Biotech
Fortress Biotech, Inc. ("Fortress") is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income. The company has a portfolio of multiple marketed prescription pharmaceutical products and 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. Fortress' portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress' model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance 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, Nationwide Children's Hospital, Columbia University, Dana-Farber Cancer Center and Sentynl Therapeutics. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
Statements in this press release that are not descriptions of historical facts are "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. The words "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "might," "plans," "potential," "predicts," "should," or "will" or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These 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 uncertainties relating to financings; uncertainty related to the timing and amounts expected to be realized from future milestone, contingent value right, royalty or similar future revenue streams, if at all; 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 product candidates under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our 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 Jaffe
Fortress Biotech, Inc.
(781) 652-4500
ir@fortressbiotech.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Balance Sheets
($ in thousands except for share and per share amounts)
June 30, December 31,
2026 2025
---------- ----------------
ASSETS
Current assets
Cash and cash equivalents $ 196,576 $ 79,381
Accounts receivable, net 36,246 29,783
Inventory 8,156 9,624
Other receivables - related party 506 158
Prepaid expenses and other current
assets 4,022 4,895
-------- ---------
Total current assets 245,506 123,841
Property and equipment, net 2,412 2,519
Operating lease right-of-use asset, net 11,357 12,302
Restricted cash 1,220 1,220
Equity investments, at fair value 29,451 17,660
Intangible assets, net 25,510 27,605
Other assets 1,259 401
-------- ---------
Total assets $ 316,715 $ 185,548
======== =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses $ 49,325 $ 47,125
Income taxes payable 5,179 356
Common stock warrant liabilities -- 1
Operating lease liabilities,
short-term 2,246 2,127
Partner company notes payable,
short-term 5,000 --
Other current liabilities 268 135
-------- ---------
Total current liabilities 62,018 49,744
Notes payable, long-term, net 34,602 52,417
Operating lease liabilities, long-term 11,468 12,672
Partner company redeemable perpetual
preferred liability -- 7,085
Other long-term liabilities 2,541 1,447
-------- ---------
Total liabilities 110,629 123,365
-------- ---------
Commitments and contingencies
Stockholders' equity
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
June 30, 2026 and December 31, 2025,
respectively, liquidation value of
$25.00 per share 3 3
Common stock, $0.001 par value,
200,000,000 shares authorized,
33,311,012 and 31,364,094 shares issued
and outstanding as of June 30, 2026 and
December 31, 2025, respectively 33 31
Additional paid-in-capital 788,251 783,891
Accumulated deficit (624,147) (734,052)
-------- ---------
Total stockholders' equity attributed to
the Company 164,140 49,873
Non-controlling interests 41,946 12,310
-------- ---------
Total stockholders' equity 206,086 62,183
-------- ---------
Total liabilities and stockholders'
equity $ 316,715 $ 185,548
======== =========
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Unaudited CondensedConsolidated Statements of Operations
($ in thousands except for share and per share amounts)
Three Months Ended June
30, Six Months Ended June 30,
-------------------------- ----------------------------
2026 2025 2026 2025
------------ ------------ ------------ --------------
Revenue
Product revenue, net $ 17,839 $ 15,009 $ 33,760 $ 28,148
Other revenue 879 1,404 996 1,404
---------- ---------- ---------- ----------
Net revenue 18,718 16,413 34,756 29,552
---------- ---------- ---------- ----------
Operating expenses
Cost of goods -
(excluding amortization
of acquired intangible
assets) 6,143 4,939 12,361 9,729
Amortization of
acquired intangible
assets 969 1,064 2,095 2,129
Research and
development 805 8,126 1,345 12,060
Selling, general and
administrative 20,807 38,757 36,699 64,424
---------- ---------- ---------- ----------
Total operating expenses 28,724 52,886 52,500 88,342
---------- ---------- ---------- ----------
Loss from operations (10,006) (36,473) (17,744) (58,790)
Other income (expense)
Interest income 1,581 622 2,151 1,112
Interest expense and
financing fee (1,476) (2,518) (4,845) (5,324)
Gain on sale of
priority review
voucher, net of
expenses -- -- 158,873 --
Change in fair value of
partner company
derivative liability -- -- (7,085) --
Gain (loss) on common
stock warrant
liabilities -- (350) 1 (397)
Gain from
deconsolidation of
subsidiary 82 27,127 82 27,127
Other income (expense) 10,741 (62) 11,783 (73)
---------- ---------- ---------- ----------
Total other income 10,928 24,819 160,960 22,445
---------- ---------- ---------- ----------
Income (loss) before
income tax expense 922 (11,654) 143,216 (36,345)
Income tax expense 320 -- 5,452 --
---------- ---------- ---------- ----------
Net income (loss) 602 (11,654) 137,764 (36,345)
========== ========== ========== ==========
Attributable to
non-controlling
interests (1,070) 27,140 (27,859) 41,247
---------- ---------- ---------- ----------
Net income (loss)
attributable to
Fortress $ (468) $ 15,486 $ 109,905 $ 4,902
========== ========== ========== ==========
Preferred A dividends
cumulated, and Fortress'
share of subsidiary
deemed dividends (2,008) (2,131) (4,016) (4,261)
---------- ---------- ---------- ----------
Net income (loss)
attributable to common
stockholders $ (2,476) $ 13,355 $ 105,889 $ 640
========== ========== ========== ==========
Net income (loss) per
common share
attributable to common
stockholders - basic $ (0.08) $ 0.50 $ 3.34 $ 0.02
Net income (loss) per
common share
attributable to common
stockholders - diluted $ (0.08) $ 0.45 $ 2.86 $ 0.02
Weighted average common
shares outstanding -
basic 31,791,173 26,879,380 31,666,585 26,679,106
Weighted average common
shares outstanding -
diluted 31,791,173 29,824,182 37,011,700 29,182,033
___________________________
(1) This press release references products being developed or commercialized by Fortress, by Fortress' private or public subsidiaries (referred to herein as "subsidiaries" or "partner companies") and by entities with whom 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.
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