MONTREAL, April 03, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX:TH) (NASDAQ:THTX), a commercial-stage biopharmaceutical company, today announced the Company will report financial results and provide a business update for its first quarter 2025 ended February 28 on Wednesday, April 9, 2025, at 8:30 a.m. ET. The call will be hosted by Paul Lévesque, President and Chief Executive Officer, who will be joined by other members of the management team, including Phili ...

Core Insights - Theratechnologies Inc. presented data indicating the limitations of using body mass index (BMI) alone for assessing cardiovascular (CV) risk in people with HIV (PWH), emphasizing the need for screening excess visceral abdominal fat (EVAF) to better identify at-risk individuals [1][2][3] Group 1: Study Findings - The VAMOS study characterized BMI as a poor independent surrogate for excess visceral adiposity and CV risk in PWH, particularly highlighting high CV risk in participants with normal or overweight BMI but high levels of EVAF [2][3] - The study involved 170 PWH who had achieved virological suppression on antiretroviral therapy (ART) for at least one year, comparing 10-year atherosclerotic cardiovascular disease (ASCVD) risk scores across different BMI categories [3][4] - Obese individuals (BMI 30-34.9 kg/m2) had the highest prevalence of EVAF at 88%, while 43% of PWH with normal BMI (20-25 kg/m2) and 47% of those classified as overweight (BMI 25-29.9 kg/m2) also exhibited EVAF [3][4] Group 2: Clinical Implications - PWH with EVAF had significantly higher 10-year ASCVD risk scores compared to those without EVAF, regardless of BMI, indicating the importance of considering EVAF in risk assessments [4][5] - The findings suggest that healthcare providers focusing solely on BMI may overlook a significant population of normal-weight and overweight individuals with HIV who are at risk due to EVAF [5] - The study advocates for the use of simple and more precise tools, such as waist circumference measurement, to identify PWH at risk of cardiovascular disease [5]

Corporate Presentation January 2025 NASDAQ: THTX TSX: TH Forward-Looking Information The following presentation contains statements that are considered forward-looking information within the meaning of securities regulation. The Forward-Looking Information ("FLI") in this presentation relates to future events or our future performance. The FLI are based on a number of assumptions and are associated with a number of risks, uncertainties and other unknown factors that may cause our actual results, levels of a ...

Theratechnologies Inc. (NASDAQ:THTX) Q4 2024 Earnings Conference Call February 26, 2024 8:30 AM ET Company Participants Joanne Choi - Senior Director, Investor Relations Paul Levesque - President & CEO Philippe Dubuc - SVP & CFO John Leasure - Global Commercial Officer Conference Call Participants Andre Uddin - Research Capital Operator Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Theratechnologies Fourth Quarter and Fiscal Year 2024 Earnings Call. We would like to remind ev ...

Financial Performance - For the fiscal year ended November 30, 2024, the Corporation incurred a net loss of $8,306,000, a decrease from a net loss of $23,957,000 in 2023 and $47,237,000 in 2022[46]. - The Corporation had positive cash flows from operating activities of $2,379,000 for the fiscal year ended November 30, 2024, compared to negative cash flows of $5,678,000 in 2023[46]. - As of November 30, 2024, the Corporation's cash amounted to $5,899,000, with bonds and money market funds totaling $3,937,000, while the accumulated deficit reached $416,887,000[46]. - The Corporation's financial results are subject to estimates and assumptions, and significant differences between estimates and actual results could negatively impact its financial position[179]. - The Corporation's financial position may be negatively impacted if actual future payments for allowances exceed its estimates[184]. Operational Risks - The Corporation's ability to continue as a going concern is contingent upon achieving positive cash flows and meeting covenants of the TD Credit Agreement and IQ Credit Agreement[46]. - The Loan Agreements impose significant operating and financial restrictions on the Corporation, limiting its ability to incur additional debt or make certain investments[68]. - The company relies on third-party manufacturers and distributors, which exposes it to risks that could adversely affect revenues and operations[84]. - The company does not have state licensure in the United States to distribute its products, relying on McKesson for distribution[87]. - The company has not qualified alternative manufacturers for its products, which could delay commercialization if current manufacturers face issues[86]. - The company may face operational disruptions if McKesson or RXC 3PL becomes unavailable, impacting distribution and sales[91]. - The company may face significant fines or penalties if promotional materials are deemed to promote off-label use, which could adversely affect its reputation and financial condition[138]. - The company relies on third-party service providers for distribution and manufacturing, and any failure to meet obligations could materially affect its business and financial results[161]. Product Development and Regulatory Approvals - The Corporation's long-term profitability will depend on the successful commercialization of EGRIFTA SV® and Trogarzo® in the U.S. and obtaining Health Canada approval for olezarsen and donidalorsen[57][58]. - The FDA allowed the Corporation to sell and distribute newly manufactured batches of EGRIFTA SV® on February 13, 2025, despite the product being manufactured without an approved PAS[49]. - The Prescription Drug User Fee Act (PDUFA) goal date for the F8 Formulation decision is set for March 25, 2025[94]. - The FDA issued a Complete Response Letter (CRL) regarding the F8 Formulation, raising questions about chemistry, manufacturing, and controls[113]. - The Corporation must file Human Factors Study (HFS) results by September 15, 2025, or risk sanctions and potential prohibition of EGRIFTA SV® sales[118]. - The Corporation is required to complete a HFS for EGRIFTA SV® by September 15, 2025, with the first part completed and the validation study pending[120]. - The company plans to submit olezarsen for priority review and donidalorsen for standard review to Health Canada in 2025[110]. - The company plans to submit olezarsen for FCS to Health Canada for review in 2025, potentially making it the first approved treatment for FCS in Canada[234]. Market and Competitive Landscape - The company's revenue growth is currently dependent on the commercialization of EGRIFTA SV® and Trogarzo® in the United States, with any unsatisfactory sales levels having a material adverse effect[72]. - EGRIFTA SV® accounts for over 50% of the Corporation's annual revenues, and the imposition of a 25% tariff on goods imported into the United States could adversely affect its financial results and profits[168]. - The patent protection for tesamorelin related to the reduction of excess abdominal fat in HIV-infected adult patients expired in August 2023, exposing the company to potential competition from biosimilar products[142]. - The company has no patent protection for the formulation of EGRIFTA SV®, which could lead to revenue reduction if biosimilars enter the market[143]. - The Corporation's revenue growth could be materially adversely impacted if a vaccine or cure for HIV is discovered[109]. Supply Chain and Inventory Management - The company does not have a long-term supply agreement with Jubilant for EGRIFTA SV®, which may lead to supply issues[81]. - The Corporation does not have a long-term supply agreement for bacteriostatic water for injection (BWFI), which may lead to supply issues[95]. - The company estimates it has an inventory of EGRIFTA SV® for up to six months, subject to underlying demand[80]. - The company may face drug shortage issues if the PAS filed with the FDA is not approved, which would prevent the release of additional batches of EGRIFTA SV®[79]. Clinical Trials and Research Development - The development of sudocetaxel zendusortide is uncertain, as future R&D activities in oncology will depend on finding partnership deals[121]. - The Corporation plans to phase down preclinical oncology research while continuing a Phase 1 clinical trial of sudocetaxel zendusortide in advanced ovarian cancer[122]. - On November 21, 2024, the Corporation submitted an amendment to the Phase 1 clinical trial protocol to assess higher doses of sudocetaxel zendusortide[124]. - The conduct of clinical trials is subject to various risks, including negative results and challenges in patient recruitment, which could delay or prevent trials[127]. - Any delays in clinical trials could adversely affect the Corporation's business prospects and long-term growth potential[130]. - Preliminary efficacy and safety data from the Phase 1b trial of sudocetaxel zendusortide showed favorable tolerability, leading to recommendations for continued evaluation[216]. Funding and Financial Stability - The Corporation may require additional funding to sustain growth and develop marketing capabilities, but market conditions may limit access to public capital[175]. - The company secured up to $75 million in new credit facilities, including a $40 million senior secured financing with TD Bank and a $15 million subordinated term loan from its largest shareholder, Investissement Québec[214]. - The company has not made any material capital expenditures in the last three financial years, but incurred capital divestiture of $6.4 million in the fiscal year ended November 30, 2022[218]. Human Resources and Management - The loss of key employees could materially adversely affect the Corporation's business and growth potential, as its success depends on retaining qualified personnel[176]. - The Corporation faces intense competition for qualified personnel, which could limit its operational capabilities and hinder business growth[177]. Cybersecurity and Data Management - The Corporation relies on third-party information technology systems for data storage, which exposes it to cybersecurity risks that could materially impact its reputation and financial condition[170].

Exhibit 99.1 Theratechnologies Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2024 Montreal – February 26, 2025 – Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, today reported business highlights and financial results for the fourth quarter and full year of fiscal year 2024, ended November 30, ...

Core Insights - Theratechnologies Inc. reported a strong financial performance for the fourth quarter and full year of fiscal year 2024, with a revenue increase of 6.6% in Q4 and 5.0% for the full year, driven by sales of EGRIFTA SV® and Trogarzo® [2][30][3] Financial Performance - Fourth-quarter revenue reached $25 million, up from $23.5 million in the same period last year, while annual revenue totaled $85.9 million compared to $81.8 million in 2023 [3][30] - EGRIFTA SV® net sales for Q4 were $17.7 million, a 4.2% increase year-over-year, and full-year sales were $60.1 million, reflecting a 12% growth [2][31] - Trogarzo® net sales in Q4 were $7.3 million, up 12.8% from the previous year, but full-year sales decreased by 8.3% to $25.7 million due to competitive pressures [2][32] - Adjusted EBITDA for Q4 was $7.8 million, a 56% increase from Q4 2023, and for the full year, it surpassed $20 million compared to a negative $3 million in 2023 [3][42] Operational Highlights - The company secured $75 million in new credit facilities, which will enhance liquidity and support growth strategies [3][10] - A temporary supply disruption for EGRIFTA SV® was resolved, allowing the company to resume distribution as of February 13, 2025 [5][49] - The FDA has set a PDUFA action date of March 25, 2025, for the updated F8 formulation of tesamorelin, which could replace the current formulation [9] Strategic Developments - The company in-licensed two new investigational drugs, olezarsen and donidalorsen, to drive long-term growth in Canada [11][60] - Theratechnologies is actively seeking a partner for its oncology program to advance the development of its novel peptide drug conjugates [4][13] Cost Management - R&D expenses for Q4 were $5.9 million, up from $5.2 million in the previous year, primarily due to an impairment loss related to the oncology program [20][34] - Selling expenses increased to $7.0 million in Q4, reflecting growth in commercial operations [23] - General and administrative expenses rose to $5.1 million, attributed to higher stock-based compensation [25] Cash Flow and Financial Position - The company reported positive cash flows from operating activities of $2.4 million for the year, a significant improvement from a negative cash flow in 2023 [46][55] - As of November 30, 2024, cash and cash equivalents totaled $5.9 million, with an accumulated deficit of $416.9 million [46]

Core Viewpoint - Theratechnologies Inc. has submitted a Prior Approval Supplement (PAS) to the FDA regarding changes in the manufacturing environment for EGRIFTA SV®, which is necessary for the distribution of recently manufactured batches [1] Group 1: Manufacturing and Regulatory Updates - The PAS will be reviewed by the FDA within four months, and approval is required before distributing the new batches of EGRIFTA SV® [1] - The company is in discussions with the FDA to expedite the release of EGRIFTA SV® to prevent a product shortage for patients [2] Group 2: Product Availability - Existing inventory levels of EGRIFTA SV® are projected to meet patient demand until mid-January 2025 [2] - EGRIFTA SV® is exclusively distributed in the United States [4] Group 3: Company Information - Theratechnologies focuses on developing and commercializing innovative therapies to address unmet medical needs [5]

Core Viewpoint - Theratechnologies has entered into a licensing agreement with Ionis Pharmaceuticals to develop and commercialize two investigational RNA-targeted medicines, olezarsen and donidalorsen, in Canada, expanding its existing HIV portfolio and addressing unmet medical needs [1][2]. Group 1: Agreement Details - The agreement grants Theratechnologies exclusive rights in Canada for olezarsen, aimed at treating familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG), and for donidalorsen, intended for hereditary angioedema (HAE) [1][2]. - Ionis will receive a $10 million upfront payment and milestone payments up to $12.75 million based on regulatory achievements and sales targets, along with tiered double-digit royalties on annual net sales [10][11]. Group 2: Product Information - Olezarsen is designed to lower the production of apoC-III, a protein that regulates triglyceride metabolism, and is being evaluated for FCS and sHTG [3]. - FCS is characterized by extremely elevated triglyceride levels and can lead to life-threatening pancreatitis, with a prevalence in Canada similar to the global average, but significantly higher in regions like Eastern Québec [4]. - sHTG affects a larger patient population, with an estimated 3 million patients in the U.S. and a similar prevalence in Canada [5]. Group 3: Regulatory Status - The FDA has accepted the New Drug Application (NDA) for olezarsen for FCS with a PDUFA action date of December 19, 2024, and Theratechnologies plans to submit to Health Canada in 2025 [6]. - Ionis has completed enrollment for the Phase 3 olezarsen clinical program for sHTG, with results expected in the second half of 2025 [7]. - The NDA for donidalorsen for HAE has also been accepted by the FDA, with a PDUFA action date of August 21, 2025, and submissions are progressing in Europe [9]. Group 4: Company Background - Theratechnologies is a biopharmaceutical company focused on developing innovative therapies for unmet medical needs, with a commitment to sustained growth and shareholder value [2][13]. - Ionis Pharmaceuticals has a strong pipeline in RNA-targeted medicines and aims to deliver innovative treatments for serious diseases [14].

Core Viewpoint - Theratechnologies Inc. has resumed the production of EGRIFTA SV® after a voluntary shutdown due to FDA inspection observations, and is working to ensure market availability and avoid patient shortages in 2025 [1][3]. Group 1: Production and Quality Control - The production of EGRIFTA SV® has resumed, and one newly manufactured batch has completed quality control, pending FDA approval for market release [2]. - Two additional batches of EGRIFTA SV® are currently in production [2]. - The company is managing existing inventory levels to meet patient demand until mid-January 2025 [2]. Group 2: Regulatory Collaboration - Theratechnologies is collaborating closely with the FDA and other stakeholders to prevent a shortage of EGRIFTA SV® at the patient level in 2025 [3]. Group 3: Future Updates - The company will provide updates on any further material developments regarding EGRIFTA SV® [4].