Full Press Release Details
Fortress Biotech Reports Record Third Quarter
2021 Financial Results and Recent Corporate Highlights
Net revenue for third quarter of 2021 increased
123% year-over-year to $21.1 million, a quarterly record
Journey Medical Corporation, a Fortress partner
company, launched its $35.2 million initial public offering
AstraZeneca acquired Caelum Biosciences;
Fortress received $56.9 million upfront1
Rolling NDA submission for CUTX-101 for the
treatment of Menkes disease is expected to be initiated in the fourth quarter of 2021
Top-line results from registration-enabling
study of cosibelimab in metastatic cutaneous squamous cell carcinoma expected around year-end 2021
New York, NY - November 15, 2021
- Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring,
developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, today announced
financial results and recent corporate highlights for the third quarter ended September 30, 2021.
Lindsay A. Rosenwald, M.D., Fortress' Chairman
and Chief Executive Officer, said, "Fortress and our partner companies continue to achieve significant clinical and corporate milestones
as we develop new treatment options for patients in need and create long-term value for our shareholders. We attained a new quarterly
record for net revenue, $21.1 million, which is an increase of 123% year-over-year. Journey Medical Corporation ("Journey"),
our partner company, launched its initial public offering ("IPO") of 3,520,000 shares at $10.00 per share for gross proceeds
of $35.2 million. Additionally, AstraZeneca's Alexion acquired Caelum Biosciences, Inc. ("Caelum") a company founded
by Fortress, for an upfront payment of approximately $150 million paid to Caelum shareholders, of which approximately $56.9 million was
paid to Fortress.1 The agreement also provides
for additional contingent payments to Caelum stockholders totaling up to $350 million, payable upon the achievement of regulatory and
commercial milestones. Fortress is eligible to receive 42.4% of all proceeds from the transaction, totaling up to approximately $212 million.
Our CAR T cell therapy portfolio continues to advance, with a $2 million grant awarded by the National Cancer Institute ("NCI")
to partially fund our Mustang Bio, Inc. ("Mustang Bio")-sponsored Phase 1/2 trial of MB-106, a CD20-targeted, autologous CAR
T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") or chronic lymphocytic leukemia
("CLL"). Finally, we announced positive data from two completed pivotal studies in patients with Menkes disease treated with
CUTX-101 at the 2021 American Academy of Pediatrics National Conference & Exhibition."
Dr. Rosenwald continued, "Looking ahead,
we anticipate continued regulatory and clinical progress including initiating the rolling submission of the new drug application ("NDA")
for CUTX-101 for the treatment of Menkes disease to the U.S. Food and Drug Administration ("FDA") later this quarter and
reporting top-line results from the registration-enabling study of cosibelimab in metastatic cutaneous squamous cell carcinoma around
year-end. We also look forward to the upcoming data presentations of MB-106 and AL amyloidosis treatment CAEL-101 at the American Society
of Hematology Annual Meeting ("ASH2021")."
In each case, figures are net of miscellaneous transcation expenses and a 10% holdback for an indemnification escrow.
Recent Corporate Highlights2:
Marketed Dermatology Products and Product Candidates
CUTX-101 (Copper Histidinate for Menkes disease)
CAEL-101 (Light Chain Fibril-reactive Monoclonal
Antibody for AL Amyloidosis)
Includes product candidates in development at Fortress, majority-owned and controlled partners and partners 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 and partners, as dictated by context.
Cosibelimab (formerly CK-301, an anti-PD-L1
MB-106 (CD20-targeted CAR T Cell Therapy)
MB-101 (IL13R 2-targeted CAR T Cell Therapy)
Novel CAR T Technology
MB-107 and MB-207 (Lentiviral Gene Therapies
for X-linked Severe Combined Immunodeficiency ("XSCID"))
Ex Vivo Lentiviral Gene Therapy for
RAG1 Severe Combined Immunodeficiency ("RAG1-SCID")
To assist our stockholders in understanding
our company, we have prepared non-GAAP financial results for the three months ended September 30, 2021 and 2020. These results
exclude the operations of our three partner companies that were public at September 30, 2021: Avenue, Checkpoint and Mustang Bio.
The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress' core operations,
which comprise our commercial-stage business, our privately held development-stage entities, as well as our business development and
Use of Non-GAAP Measures:
In addition to the GAAP financial measures as
presented in our Form 10-Q that will be filed with the Securities and Exchange Commission ("SEC") on November 15, 2021, the
Company has, in this press release, included certain non-GAAP measurements. The non-GAAP net income (loss) attributable to common stockholders
is defined by the Company as GAAP net income (loss) attributable to common stockholders, less net losses attributable to common stockholders
from our public partner companies Avenue, Checkpoint and Mustang Bio. 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 income (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, Qbrexza inventory step-up and depreciation expense.
The Company included the partial realization of gain in connection with the exercise of the Caelum option.
Management believes use 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 results. However, non-GAAP income (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.
tables below provide a reconciliation from GAAP to non-GAAP measures:
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| ($ in thousands except for share and per share amounts) | 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Net loss attributable to common stockholders | $ | (20,781 | ) | $ | (15,547 | ) | $ | (33,138 | ) | $ | (41,231 | ) | ||||
| Net loss attributable to common stockholders - Avenue 1 | (196 | ) | (234 | ) | (636 | ) | (718 | ) | ||||||||
| Net loss attributable to common stockholders - Checkpoint 2 | (2,126 | ) | (886 | ) | (4,995 | ) | (1,798 | ) | ||||||||
| Net loss attributable to common stockholders - Mustang 3 | (3,085 | ) | (3,082 | ) | (8,499 | ) | (7,332 | ) | ||||||||
| Non-GAAP net income (loss) attributable to common stockholders | $ | (15,374 | ) | $ | (11,345 | ) | $ | (19,007 | ) | $ | (31,383 | ) | ||||
| Stock based compensation | 2,594 | 1,678 | 7,404 | 5,264 | ||||||||||||
| Non-cash interest | 2,037 | 1,662 | 2,745 | 1,154 | ||||||||||||
| Amortization of licenses | 658 | 355 | 1,983 | 1,065 | ||||||||||||
| Amortization of debt discount | 720 | 2,120 | 1,623 | 5,238 | ||||||||||||
| Depreciation | 1,590 | 148 | 1,868 | (645 | ) | |||||||||||
| Increase in fair value of investment 4 | (8,376 | ) | (575 | ) | (39,294 | ) | (575 | ) | ||||||||
| Change in fair value of derivative liabilities 5 | 2 | 803 | 184 | 1,189 | ||||||||||||
| Qbrexza inventory step-up 6 | 3,001 | - | 4,239 | - | ||||||||||||
| Realization in Caelum investment 7 | 56,860 | - | 56,860 | - | ||||||||||||
| Fortress non-GAAP income (loss) attributable to common stockholders | $ | 43,711 | $ | (5,154 | ) | $ | 18,603 | $ | (19,882 | ) | ||||||
| Per common share - basic and diluted: | ||||||||||||||||
| Net income (loss) attributable to common stockholders (GAAP) | $ | (0.26 | ) | $ | (0.20 | ) | $ | (0.41 | ) | $ | (0.59 | ) | ||||
| Non-GAAP net income (loss) attributable to common stockholders | $ | (0.19 | ) | $ | (0.15 | ) | $ | (0.23 | ) | $ | (0.45 | ) | ||||
| Fortress non-GAAP income (loss) attributable to common stockholders | $ | 0.54 | $ | (0.07 | ) | $ | 0.23 | $ | (0.29 | ) | ||||||
| Weighted average common shares outstanding - basic and diluted | 81,348,243 | 76,093,211 | 81,056,165 | 69,404,499 |
to non-GAAP research and development and selling, general and administrative costs:
| For the quarter ended September 30, | For the nine months ended September 30, | |||||||||||||||
| ($ in thousands) | 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Research and development 1 | $ | 28,080 | $ | 13,756 | $ | 85,811 | $ | 46,146 | ||||||||
| Less: | ||||||||||||||||
| Research and development Avenue | 278 | 466 | 864 | 2,382 | ||||||||||||
| Research and development Checkpoint | 9,384 | 2,543 | 20,795 | 8,207 | ||||||||||||
| Research and development Mustang 2 | 14,651 | 7,925 | 38,046 | 26,948 | ||||||||||||
| Non-GAAP research and development costs | $ | 3,767 | $ | 2,822 | $ | 26,108 | $ | 8,609 | ||||||||
| Selling, general and administrative | $ | 22,221 | $ | 15,383 | $ | 59,145 | $ | 45,358 | ||||||||
| Less: | ||||||||||||||||
| Selling, general and administrative Avenue | 594 | 571 | 1,960 | 1,832 | ||||||||||||
| Selling, general and administrative Checkpoint 3 | 1,759 | 1,573 | 5,109 | 4,622 | ||||||||||||
| Selling, general and administrative Mustang 4 | 2,226 | 1,640 | 6,522 | 5,325 | ||||||||||||
| Non-GAAP selling, general and administrative costs | $ | 17,641 | $ | 11,599 | $ | 45,553 | $ | 33,579 |
About Fortress Biotech
Fortress Biotech, Inc. ("Fortress")
is an innovative biopharmaceutical company that was ranked in Deloitte's 2019 and 2020 Technology Fast 500 , annual rankings
of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors,
based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing
high-potential marketed and development-stage drugs and drug candidates. The company has seven marketed prescription pharmaceutical products
and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners 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 Statements
This press release may contain "forward-looking