NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO), an innovative revenue-generating 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 second quarter ended June 30, 2020.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “Fortress has continued to efficiently and effectively execute on its growth objectives due to our unique business model. We are proud to have generated total net revenue of $21.4 million from our five marketed pharmaceutical products in the first half of 2020, a year-over-year increase of 50%, despite this unprecedented time. Moreover, during the second quarter, we acquired a broad platform technology from Columbia University to effectively deliver novel, proprietary oligonucleotides for the treatment of genetically driven cancers, with an initial target of KRAS-driven cancers. We are also exploring the potential of the platform to treat novel coronaviruses, such as COVID-19.”
Dr. Rosenwald continued, “Additionally, we continue to work with our partner companies to steadily build and advance our growing portfolio of commercial and development-stage product candidates. Our goal is to increase intrinsic value for our shareholders. In the second half of 2020, we look forward to a multitude of key inflection points, including: additional data from our registration-enabling clinical trial of cosibelimab in patients with metastatic cutaneous squamous cell carcinoma (“mCSCC”), the PDUFA date for IV tramadol in October and initiating the rolling submission of the New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for CUTX-101 for the treatment of Menkes disease. We also anticipate the potential launch of four more registration-enabling clinical trials this year, two CAEL-101 pivotal trials for AL amyloidosis and two MB-107 and MB-207 lentiviral gene therapy clinical trials for newly diagnosed infants and previously transplanted patients with X-linked severe combined immunodeficiency (“XSCID”).”
| Recent Corporate Highlights1: | ||||
| Marketed Dermatology Products | ||||
| Our dermatology products are marketed by our partner company, Journey Medical Corporation (“Journey”). | ||||
| Our products generated $21.4 million in revenues in the first half of 2020, compared to $14.3 million in the first half of 2019, representing growth of 50% year-over-year. Our products generated second quarter 2020 net revenues of $9.4 million, compared to second quarter 2019 net revenues of $8.2 million, a 15% increase. Second quarter sales were below expectations due to COVID-19. | ||||
| We intend to acquire up to two new prescription products in 2020. | ||||
| IV Tramadol | ||||
| In April 2020, Avenue Therapeutics (“Avenue”) announced that two e-posters highlighting efficacy and safety results from its Phase 3 program are available for online viewing from the cancelled Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine (“ASRA”). | ||||
| In June 2020, Avenue announced the following clinical study publications in peer-reviewed journals. | ||||
| In July 2020, Avenue announced the following publication of its Phase 3 bunionectomy study. | ||||
| The FDA assigned IV tramadol a PDUFA date of October 10, 2020. | ||||
| IV tramadol is currently in development at our partner company, Avenue. | ||||
| CUTX-101 (Copper Histidinate for Menkes disease) | ||||
| In June 2020, we announced the publication of a study, “Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome Aggregation Database (gnomAD),” in Molecular Genetics and Metabolism Reports. Assuming Hardy-Weinberg genetic equilibrium, the allelic frequency of loss-of-function variants suggests a minimum birth prevalence for Menkes disease of 1 in 34,810 males, higher than previously recognized. If likely pathogenic missense variants are included, the estimated birth prevalence could potentially be as high as 1 in 8,664 live male births. The study can be accessed here. | ||||
| In July 2020, we announced the publication of a study, “Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease,” in Molecular Genetics and Metabolism Reports. The study assessed the analytic validity of an ATP7A targeted next generation DNA sequencing assay as a potential newborn screen for Menkes disease, an X-linked recessive disorder of copper metabolism caused by mutations in ATP7A, an evolutionarily conserved copper-transporting ATPase. The study can be accessed here. | ||||
| In July 2020, we announced that the European Medicines Agency (“EMA”) Committee for Orphan Medicinal Products issued a positive opinion on Cyprium Therapeutics’ application for Orphan Drug Designation for Copper Histidinate, also referred to as CUTX-101, a potential treatment for Menkes disease. EMA Orphan Drug Designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and 10 years of market exclusivity. The FDA previously granted Orphan Drug, Fast Track and Rare Pediatric Disease Designations to CUTX-101 for the treatment of Menkes disease. | ||||
| We intend to begin the rolling submission of the NDA for CUTX-101 to the FDA in the fourth quarter of 2020. | ||||
| CUTX-101 is currently in development at our partner company, Cyprium Therapeutics, Inc. | ||||
| Cosibelimab (anti-PD-L1 antibody) | ||||
| In April 2020, we announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available. | ||||
| In July 2020, we announced that an abstract highlighting updated interim safety and efficacy data from the ongoing registration-enabling clinical trial of cosibelimab in patients with mCSCC was accepted for e-poster presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, to be held September 19-21, 2020. | ||||
| The registration-enabling study in mCSCC is currently over 50% enrolled, with full enrollment anticipated around year-end. With a potentially favorable safety profile and a plan to commercialize at a substantially lower price, we believe cosibelimab can be a market disruptive product in the $25 billion and growing PD-(L)1 class. | ||||
| Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. | ||||
| CAEL-101 (light chain fibril-reactive monoclonal antibody for AL amyloidosis) | ||||
| Dosing is complete in the Phase 2 dose selection portion of the program; the Phase 3 portion of the pivotal program is planned to begin in the third quarter of 2020, pending dose selection. | ||||
| CAEL-101 is currently in development at Caelum Biosciences, Inc. | ||||
| MB-107 and MB-207 (lentiviral gene therapies for XSCID) | ||||
| In April 2020, we announced that the EMA granted Advanced Therapy Medicinal Product (“ATMP”) classification to MB-107, a lentiviral gene therapy for the treatment of XSCID, also known as bubble boy disease. | ||||
| In May 2020, Mustang Bio, Inc. (“Mustang”) submitted an Investigational New Drug (“IND”) application to the FDA to initiate a multi-center Phase 2 clinical trial of MB-107 in newly diagnosed infants with XSCID who are under the age of two. The trial is expected to enroll 10 patients who, together with 15 patients enrolled in the current multicenter trial led by St. Jude Children’s Research Hospital, will be compared to 25 matched historical control patients who have undergone hematopoietic stem cell transplant (“HSCT”). The primary efficacy endpoint will be event-free survival. The initiation of this trial is currently on hold pending CMC clearance by the FDA, which is expected in early Q4 2020. Mustang is targeting top-line data from the trial in the second half of 2022. | ||||
| Mustang further expects to file an IND in the fourth quarter of 2020 for a registrational multi-center Phase 2 clinical trial of its lentiviral gene therapy in previously transplanted XSCID patients. This product will be designated MB-207. Mustang anticipates enrolling 20 patients and evaluating those subjects in comparison to matched historical control patients who have undergone a second HSCT. Mustang is targeting top-line data from this trial in the second half of 2022. | ||||
| MB-107 and MB-207 are currently in development at our partner company, Mustang. | ||||
| MB-104 (CS1-targeted CAR T cell therapy) | ||||
| In May 2020, City of Hope presented two posters pertaining to MB-104, an innovative CS1 CAR T cell therapy, at the virtual 23rd Annual Meeting of the American Society of Gene & Cell Therapy (“ASGCT”). | ||||
| MB-104 is currently in development at our partner company, Mustang. | ||||
| ONCOlogues (proprietary platform technology using PNA oligonucleotides) | ||||
| In May 2020, we entered into an exclusive worldwide licensing agreement with Columbia University to develop novel oligonucleotides for the treatment of genetically driven cancers. The proprietary platform produces oligomers, known as “ONCOlogues,” which are capable of binding gene sequences 1,000 times more effectively than complementary native DNA. | ||||
| In addition, we are exploring the potential of the platform to treat novel coronaviruses, such as COVID-19. | ||||
| The “Suppression of KRAS-G12D and BRAF-V600E Oncogene Transcription with PNA Conjugates,” data presentation from the ESMO Congress in 2019 can be found here. | ||||
| The ONCOlogues platform is currently in development at our partner company, Oncogenuity, Inc. | ||||
| General Corporate | ||||
| In May 2020, we closed on a gross total of approximately $11.5 million in an underwritten public offering of our 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock. | ||||
| In June 2020, Fortress and Avenue were added to the Russell 3000® index. | ||||
| • | As of June 30, 2020, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $199.9 million, compared to $152.5 million as of March 31, 2020 and $153.4 million as of December 31, 2019. |
| • | Fortress’ net revenue totaled $9.5 million for the second quarter of 2020, which included $9.4 million in net revenue generated from our marketed dermatology products. This compares to net revenue totaling $9.3 million for the second quarter of 2019, which included $8.2 million in net revenue generated from our marketed dermatology products. |
| • | On a GAAP basis, consolidated research and development expenses were $15.7 million for the second quarter of 2020, compared to $18.5 million for the second quarter of 2019. On a non-GAAP basis, research and development expenses were $1.7 million for the second quarter of 2020, compared to $1.2 million for second quarter of 2019. |
| • | On a GAAP basis, consolidated research and development expenses from license acquisitions totaled $1.6 million for the second quarter of 2020, compared to $0.2 million for the second quarter of 2019. |
| • | On a GAAP basis, consolidated general and administrative expenses were $14.5 million for the second quarter of 2020, compared to $13.4 million for the second quarter of 2019. On a non-GAAP basis, general and administrative expenses were $10.4 million, of which $4.8 million is attributed to Journey, for the second quarter of 2020, compared to $9.4 million, of which $4.9 million is attributed to Journey, for the second quarter of 2019. |
| • | On a GAAP basis, consolidated net loss attributable to common stockholders was $13.3 million, or $0.19 per share, for the second quarter of 2020, compared to net loss attributable to common stockholders of $13.1 million, or $0.24 per share for the second quarter of 2019. |
| • | Fortress’ non-GAAP loss attributable to common stockholders was $3.7 million, or $0.05 per share, for the second quarter of 2020, compared to Fortress’ non-GAAP loss attributable to common stockholders of $2.4 million, or $0.04 per share, for the second quarter of 2019. |
Use of Non-GAAP Measures:
In addition to the GAAP financial measures as presented in our Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on August 10, 2020, the Company, in this press release, has included certain non-GAAP measurements. The non-GAAP loss attributable to common stockholders is defined by the Company as GAAP net loss attributable to common stockholders, less net losses from our public partner companies Avenue, Checkpoint, and Mustang, as well as 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, and depreciation.
Management believes 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 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.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was recently ranked number 10 in Deloitte’s 2019 Technology Fast 500™, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has five 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 Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com.
