Q1 2024 consolidated revenue of $16.2 million Report marks third consecutive quarter of near-flat-to-positive Adjusted EBITDA1 FY2024 revenue guidance confirmed between $87 and $90 million and an Adjusted EBITDA in the range of $13-15 million Acceleration of Phase 1 trial of sudocetaxel zendusortide in advanced ovarian cancer with enrollment of next cohort of patients underway at higher dose level MONTREAL, April 10, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today reported business highlights and financial results for the first quarter of fiscal year 2024 ended February 29, 2024 (Q1 2024). All figures are in US dollars unless otherwise stated. "I am pleased to wrap up the quarter by reaffirming our full year 2024 guidance of revenues between $87 and $90 million and an Adjusted EBITDA in the range of $13-15 million. Our new cost structure together with our strategic focus on commercial capabilities puts Theratechnologies on the brink of producing stronger cash flow and value for shareholders," said Paul Lévesque, President and Chief Executive Officer at Theratechnologies. "EGRIFTA SV® continues to be our engine of growth and according to key performance metrics such as enrollments and unique patients, we are on track to achieve and even surpass our long-term objectives. As anticipated during our recent fourth quarter call, we are experiencing some variability in revenue growth reporting based on the buildup and subsequent drawdown of inventories in the early part of fiscal 2023. Despite lower revenues this quarter, we expect a reverse trend in the second quarter and an evening out of revenues in the second half of 2024. We continue to demonstrate strength on the bottom line, with an improved net loss of $4.4 million versus a net loss of $10.4 million in Q1 2023. This quarter also marks our third consecutive quarter of near-flat-to-positive Adjusted EBITDA, up more than $3.6 million2 from Q1 2023." Lévesque added, "Following our recent Type A meeting with the FDA on the sBLA for tesamorelin F8, we remain on track to resubmit our file and receive a decision from the FDA on this new product formulation before the end of 2024. With M&A more important than ever to the evolution of portfolio and our overall growth strategy, I am confident that our positive trajectory of Adjusted EBITDA will facilitate the acquisition of new assets that should contribute to value creation for our business. We continue to prioritize our Phase 1 clinical trial studying sudocetaxel zendusortide in advanced ovarian cancer and welcome its acceleration with the recent milestone of the enrollment of the next cohort of patients at the higher dose level. Now that we have significantly advanced our oncology program with important evidence on multiple PDCs with different payloads, coupled with the more than 40 patients already treated with sudocetaxel zendusortide, we believe we are in a position of strength to continue engaging with a partner for additional developmental steps." First-Quarter 2024 Revenues(in thousands of U.S. dollars)   Three Months Ended Change   February 29, 2024 February 28, 2023   EGRIFTA SV® net sales 9,586 12,711 (24.6 %) Trogarzo® net sales 6,661 7,197 (7.4 %) Revenue 16,247 19,908 (18.4 %) Recent Highlights: Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology™ On February 15, 2024, the Company announced the completion of enrollment of the first six participants in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer, and on March 21, 2024, we announced that we were moving to the next dose level in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. The study's Medical Review Committee (MRC) has deemed the dose level in the first cohort of patients safe and has approved initiation of the next cohort with an increased dose, in accordance with the updated dose optimization protocol. Study centers are now actively recruiting patients for the second cohort, with one patient already enrolled and treated with the higher dose. On March 22, 2024, the Company announced that it will phase down its preclinical oncology research activities. The Company will continue to prioritize its ongoing Phase 1 clinical trial of sudocetaxel zendusortide, in patients with advanced ovarian cancer. The phasing down of research activities is aligned with the Company's focus on its commercial business and will further optimize its organizational cost structure, pursuant to the goal of generating positive Adjusted EBITDA. These changes are expected to result in a restructuring charge of approximately $600,000 in cash charges related to severance and other expenses and approximately $800,000 in non-cash charges. The Company anticipates all charges to be fully taken during 2024. Appointment of new members to the Board of Directors On March 21, 2024, the Company announced the appointment of Jordan Zwick, Chief Business Officer at Mirador Therapeutics Inc., to its Board of Directors and as a member of the Company's Audit Committee. On April 5, 2024, the Company announced the appointment of Elina Tea, CFA, Chief Financial Officer at GLS North America, to its Board of Directors, as the designated candidate to Investissement Québec ("IQ") pursuant to the shareholder rights agreement entered into between Theratechnologies and IQ in October 2023. Ms. Tea has also been appointed to the Company's Audit Committee. With the appointments of Jordan Zwick and Elina Tea, the Company's Audit Committee will now comprise four independent members including Gérald Lacoste and Frank Holler as Chair. American Association for Cancer Research ("AACR") On March 28, 2024, Theratechnologies announced that two posters would be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024, demonstrating the potential of its SORT1+ Technology™ platform – including novel camptothecin-peptide conjugates and its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), as anticancer treatments. These preclinical presentations reinforce existing data for sudocetaxel zendusortide to activate anti-PD-L1 immunotherapy tumor cell killing in SORT+1 cancers and provide the first evidence for novel camptothecin-peptide conjugates in the treatment of SORT1+ colorectal cancers. 2024 Revenue and Adjusted EBITDA Guidance Our anticipated FY2024 revenue guidance range is confirmed between $87 million and $90 million, or growth of the commercial portfolio in the range of 6.4% and 10.0%, as compared to the 2023 fiscal year results. We anticipate Adjusted EBITDA, a non-IFRS measure, to be between $13 and $15 million for fiscal 2024. First Quarter Fiscal 2024 Financial Results The financial results presented in this press release are taken from the Company's Management's Discussion and Analysis ("MD&A") and interim consolidated financial statements ("Interim Financial Statements") for the three-month period ended February 29, 2024 ("First Quarter Fiscal 2024") which have been prepared in accordance with International Accounting Standard ("IAS") 34, Interim Financial Reporting of International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB"). The MD&A and the Interim Financial Statements can be found at www.sedarplus.ca, on EDGAR at www.sec.gov and at www.theratech.com. Unless specified otherwise, all amounts in this press release are in U.S. dollars and all capitalized terms have the meaning ascribed thereto in our MD&A. First Quarter Fiscal 2024 Financial Results RevenueConsolidated revenue for the three months ended February 29, 2024, amounted to $16,247,000 compared to $19,908,000 for the same period last year, representing a decrease of 18.4%. For the first quarter of Fiscal 2024, sales of EGRIFTA SV® reached $9,586,000 compared to $12,711,000 in the first quarter of the prior year, representing a decrease of 24.6%. Lower sales of EGRIFTA SV® were mostly the result of lower unit sales due to unusual loading of inventories which occurred in the first quarter of 2023 (mostly in December 2022 and January 2023). EGRIFTA SV® sales were also impacted by larger government rebates and returns in the first quarter of fiscal 2024. In the first quarter of Fiscal 2024, Trogarzo® sales amounted to $6,661,000 compared to $7,197,000 for the same quarter of 2023, representing a decrease of 7.4%. Trogarzo® unit sales in the first quarter of 2024 were down mostly as a result of the inventory loading at specialty pharmacies that occurred in the first quarter of 2023. Cost of ...