Q2 revenue of $22 million represents +25% growth year-over-year Positive net income of $1 million realized with Adjusted EBITDA1 of $5.5 million Fiscal 2024 revenue guidance confirmed between $87 and $90 million and an Adjusted EBITDA in the range of $13 to $15 million MONTREAL, July 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 second quarter of fiscal year 2024 ended May 31, 2024 (Q2 2024). All figures are in US dollars unless otherwise stated. Revenue for Q2 2024 and First Half Fiscal 2024 (in thousands of dollars)   Three monthsended May 31 % change Six months ended May 31 % change   2024 2023   2024 2023   EGRIFTA SV® net sales 16,200 10,853 49.3% 25,786 23,564 9.4% Trogarzo® net sales 5,817 6,696 (13.1%) 12,478 13,893 (10.2%) Revenue 22,017 17,549 25.5% 38,264 37,457 2.2% "I am pleased to wrap up this very strong second quarter with $22 million in revenue, $1 million in net income and $5.5 million in Adjusted EBITDA," said Paul Lévesque, President and Chief Executive Officer at Theratechnologies. "At this halfway mark of our fiscal year, we can reaffirm our full year 2024 guidance of revenues between $87 and $90 million and an Adjusted EBITDA in the range of $13 to $15 million. EGRIFTA SV® remains our priority brand, with key performance metrics showing consistent growth and continued strong gross margins. Moving forward we expect sales to align with patient demand, now that inventory levels have returned to normal. We continue to demonstrate strength on the bottom-line with our fourth straight quarter of near-flat-to-positive Adjusted EBITDA. In fact, for the first time in the Company's recent history, we recorded a positive net income marking the beginning of a new and profitable journey for Theratechnologies. "Regarding our pipeline, we are still addressing questions from the FDA on the tesamorelin F8 sBLA following our Type A meeting earlier this year. The FDA has confirmed a four-month review. In oncology, we continue to be focused on generating results from Part 3 of our Phase 1 clinical trial of sudocetaxel zendusortide in advanced ovarian cancer. I am pleased to confirm that we have fully recruited for the second cohort of the study, with six patients already having completed the first treatment cycle at the higher dose of 2.5 mg/kg and evaluable for safety. In parallel, we have advanced three additional peptide-drug conjugates (PDCs) using the same payloads as antibody-drug conjugate (ADC) technology, such as exatecan. We continue to engage with interested parties to further fund the development of our lead PDC candidate and SORT1+ TechnologyTM platform." Recent Highlights: Reorganization of Preclinical Oncology Research Activities On March 22, 2024, the Company announced that it would phase down its preclinical oncology research activities while continuing to conduct its ongoing Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. The phasing down of preclinical research activities is aligned with the Company's business strategy to focus on its commercial business and generating positive Adjusted EBITDA and positive net income. As a result, for the three and six-month periods ended May 31, 2024, $336,000 was recorded in charges related to severance and other expenses and a charge of approximately $200,000 is expected to be recorded in the second half of 2024. In addition, the Company recorded in the three and six-month periods ended May 31, 2024, $766,000 in accelerated depreciation on equipment in research and development expenses. Sudocetaxel Zendusortide Presentation at ASCO 2024 Demonstrates Signs of Long-Term Efficacy and Manageable Safety Profile in Patients with Solid Tumors At the 2024 American Society of Clinical Oncology (ASCO) annual meeting, the Company presented Phase 1 data from Parts 1 and 2 of the clinical trial with its lead investigational PDC candidate sudocetaxel zendusortide demonstrating signs of long-term efficacy and a manageable safety profile in patients with solid tumors. Study results suggest a unique, multimodal mechanism of action for sudocetaxel zendusortide that are distinct from other cancer therapeutics, including induction of immune cell infiltration even in "cold" tumor models, inhibition of vasculogenic mimicry, targeting of chemotherapy-resistant cancer stem cells, and activation of the cGAS/STING immune pathway. Additionally, investigators observed an early efficacy signal primarily in female cancers (ovarian cancer, endometrial cancer, triple-negative breast cancer [TNBC]), with seven of 16 participants (44%) achieving a clinical benefit (complete response + partial response + stable disease), as confirmed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Theratechnologies Reports on its Annual Meeting of Shareholders At its annual meeting of shareholders held on May 9, 2024, shareholders proceeded to elect its candidates to the Company's Board of Directors for a one-year term and appointed KPMG LLP as the Company's auditors for the current fiscal year. All candidates proposed for the position of director were elected, including recently appointed Directors Elina Tea and Jordan Zwick. Frank Holler will now act as Chairman of the Board of Directors. Fiscal 2024 Revenue and Adjusted EBITDA Guidance The Company's anticipated Fiscal 2024 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. Theratechnologies anticipates Adjusted EBITDA, a non-IFRS measure, to be between $13 and $15 million for Fiscal 2024. Second 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- and six month periods ended May 31, 2024 ("Second 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 capitalized terms have the meaning ascribed thereto in our MD&A. Second Quarter Fiscal 2024 Financial Results For the three- and six-month periods ended May 31, 2024, consolidated revenue was $22,017,000 and $38,264,000, compared to $17,549,000 and $37,457,000 for the same periods ended May 31, 2023, representing year-over-year increases of 25.5% for the second quarter and 2.2% for the first half of the Fiscal 2024. For the second quarter of Fiscal 2024, net sales of EGRIFTA SV® were $16,200,000 compared to $10,853,000 in the second quarter of fiscal 2023, representing an increase of 49.3% year-over-year.  Stronger sales of EGRIFTA SV® in the second quarter were mostly the result of strong demand for the product, combined with weaker than usual sales in Q2 of last year stemming from drawdowns in inventory early in the second quarter of 2023. Net sales for the six-month period ended May 31, 2024, which amounted to $25,786,000 compared to $23,564,000 in the same period in 2023, representing growth of 9.4%. Trogarzo® net sales in the second quarter of Fiscal 2024 amounted to $5,817,000 compared to $6,696,000 for the same quarter of 2023, representing a decrease of 13.1% year-over-year.  Lower sales of Trogarzo® were mostly due to competitive pressures in the multi-drug resistant segment of the HIV-1 market, where Trogarzo remains an important part of the treatment arsenal but has lost market share to market leaders in the segment. For the six-month period ended May 31, 2024, Trogarzo® net sales were $12,478,000 compared to $13,893,000 in the same period in 2023.  Cost of Sales For the three- and six-months ended May 31, 2024, cost of sales was $4,547,000 and $9,831,000 compared to $4,909,000 and $9,602,000 for the same periods in fiscal 2023. Cost of Sales   Three monthsended May 31 Six months ended May 31   2024 2023 2024 2023   ($000s) % of Revenue ($000s) % of Revenue ($000s) % of Revenue ($000s) % of Revenue EGRIFTA SV® 1,549 9.6% 1,187 10.9% 3,436 13.3% 2,226 9.4% Trogarzo® 2,998 51.5% 3,722 55.6% 6,395 51.2% 7,376 53.0% Total 4,547 20.7% 4,909 28.0% 9,831 25.7% 9,602 25.6% For the three- and six-month periods ended May 31, 2024, EGRIFTA SV® cost of sales was affected by a $251,000 and $1,088,000 provision related to the manufacturing of a batch of F8 formulation of tesamorelin, as the F8 formulation has not yet been approved by the FDA for commercialization. Trogarzo® cost of sales is contractually established at 52% of net sales, subject to periodic adjustment for returns or other factors. R&D Expenses R&D expenses in the three- and six-month periods ended May 31, 2024, amounted to $4,725,000 and $8,477,000 compared to $10,389,000 and $19,745,000 in the comparable periods of fiscal 2023. R&D expenses in the three-month period ended May 31, 2024, include the accelerated depreciation ($766,000) of equipment used as part of the preclinical oncology research activities, following the decision to cease early-stage R&D ...