Fortress Biotech(US:FBIO)2023-05-14 16:00Financial Performance - Journey's commercial portfolio generated net revenue of $12.2 million for the three months ended March 31, 2023, down from $20.8 million in the same period of 2022[179]. - For the three months ended March 31, 2023, net revenue was $12.4 million, a decrease of 48% from $23.9 million in the same period of 2022[196][207]. - Product revenue, net decreased by $8.6 million, or 42%, primarily due to higher gross-to-net allowances and lower unit sales volumes for key products[205][207]. - The company reported a net loss attributable to common stockholders of $21.5 million for the three months ended March 31, 2023, an increase of 37% from a net loss of $15.8 million in the same period of 2022[205]. - As of March 31, 2023, the company had an accumulated deficit of $655.7 million, indicating ongoing financial challenges[198]. - Collaboration revenue decreased to $0.2 million in Q1 2023 from $0.6 million in Q1 2022, reflecting changes in project timelines[196][208]. - Total other income increased by $5.9 million, or 269%, from a loss of $2.2 million in Q1 2022 to an income of $3.7 million in Q1 2023[216]. - Cash used in operating activities decreased by $3.6 million from $46.9 million in Q1 2022 to $43.2 million in Q1 2023[221]. - Net cash provided by financing activities decreased by $32.8 million from $50.0 million in Q1 2022 to $17.2 million in Q1 2023[223]. - Cash and cash equivalents as of March 31, 2023, totaled $152.5 million, with $55.3 million related to Fortress[224]. Research and Development - Research and development expenses for the three months ended March 31, 2023 were approximately $35.3 million, a slight decrease from $36.7 million in the same period of 2022[200]. - Research and development spending at Checkpoint increased by $1.1 million, primarily due to increased regulatory costs[212]. - The increase in research and development licenses acquired was $4.2 million, or 100%, due to a new license with AnnJi[213]. - Research and development expenses decreased by $1.4 million, or 4%, from $36.7 million in Q1 2022 to $35.3 million in Q1 2023[210]. Product Development and Milestones - CUTX-101 demonstrated a 79% reduction in the risk of death in patients treated within four weeks of birth compared to historical controls, with median overall survival of 177.1 months versus 16.1 months[184]. - Cosibelimab's Biologics License Application was accepted by the FDA with a PDUFA goal date of January 3, 2024, indicating no potential filing review issues[184]. - DFD-29 achieved a 66.04% treatment success rate in Investigator's Global Assessment compared to 33.33% for Oraycea, demonstrating nearly double the efficacy[184]. - MB-106 is generating favorable safety and efficacy data, with a product profile compared to CD19-directed CAR Ts that have an annualized run rate of $3 billion in net sales[190]. - Dotinurad was approved in Japan in 2020 and is expected to begin pivotal clinical trials in early 2024, following positive Phase 3 results in over 1,000 patients[190]. - The FDA is expected to accept AstraZeneca's BLA submission for CAEL-101 for review during calendar year 2024[184]. - Fortress's subsidiaries and partner companies are actively pursuing multiple late-stage product candidates, including CAEL-101 and CUTX-101, with significant clinical milestones anticipated in 2023 and 2024[184]. Expenses and Cost Management - Selling, general and administrative expenses were approximately $25.3 million for the three months ended March 31, 2023, compared to $26.3 million in the same period of 2022[202]. - Cost of goods sold decreased by $1.8 million, or 21%, primarily due to lower product royalties related to decreased sales volumes[209]. - Stock-based compensation expenses decreased by $473,000, or 33%, from $1.42 million in Q1 2022 to $947,000 in Q1 2023[210]. - General and administrative expenses decreased by $0.9 million, or 4%, from $26.3 million in Q1 2022 to $25.3 million in Q1 2023[214]. Financing Activities - The company completed a registered direct offering in February 2023, raising approximately $13.9 million in gross proceeds[194]. - Mustang executed a 15-for-1 reverse stock split in April 2023 to comply with Nasdaq listing requirements[194]. - For the three-month period ended March 31, 2023, the Company issued approximately 0.6 million shares at an average price of $0.76, resulting in gross proceeds of $0.5 million[227]. - On February 10, 2023, the Company completed a registered direct offering, issuing 16,642,894 shares at a purchase price of $0.835 per share, securing approximately $13.3 million in net proceeds[228]. - As of March 31, 2023, approximately $11.1 million of securities remain available for sale under the 2020 Shelf registration statement[227]. - As of March 31, 2023, approximately $14.8 million of the Checkpoint shelf remains available for sale through the Checkpoint 2020 S-3[233]. - In March 2023, Checkpoint filed a new shelf registration statement allowing for the sale of up to $150 million of its securities, effective May 5, 2023[234]. - During the three months ended March 31, 2023, Urica issued an aggregate of 34,160 Urica Class B Preferred Stock at a price of $25.00 per share, for gross proceeds of $0.8 million[238]. - Avenue received $2.8 million in net proceeds from a registered direct offering and concurrent private placement of common stock and warrants[236]. - As of March 31, 2023, there have been no sales of securities under the Mustang 2021 S-3 registration statement[231]. - The Company has determined that liability classification is appropriate for certain instruments, which were accounted for as liabilities as of March 31, 2023[238]. - There were no material changes in the Company's contractual obligations and commitments during the three months ended March 31, 2023[239].