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Theratechnologies(THTX) - 2025 Q1 - Quarterly Report
2025-04-09 13:51
Exhibit 99.1 Interim Consolidated Financial Statements (In thousands of United States dollars) THERATECHNOLOGIES INC. Three-month periods ended February 28, 2025 and February 29, 2024 (Unaudited) T H E RAT E C H N O L O G I E S I N C . Ta b l e o f C o n t e n t s ( I n t h o u s a n d s o f U n i t e d S t a t e s d o l l a r s ) ( U n a u d i t e d ) P a g e I n t e r i m C o n s o l i d a t e d S t a t e m e n t s o f F i n a n c i a l P o s i t i o n 1 I n t e r i m C o n s o l i d a t e d S t a t e m e ...
Theratechnologies Reports Financial Results for the First Quarter 2025 and Reviews Key Achievements
Newsfilter· 2025-04-09 11:30
Core Insights - Theratechnologies reported a total revenue of $19 million for Q1 2025, reflecting a year-over-year growth of 17% [2][15][30] - The company achieved a net profit of $117,000, a significant improvement from a net loss of $4.48 million in Q1 2024 [30][34] - EGRIFTA SV® net sales increased by 44.8% to $13.88 million, while Trogarzo® sales decreased by 22.4% to $5.17 million [2][18] Financial Performance - Total revenue for Q1 2025 was $19,047,000 compared to $16,247,000 in Q1 2024, marking a 17.2% increase [15] - EGRIFTA SV® sales reached $13,880,000, up from $9,586,000 in the previous year, driven by higher unit sales and pricing [16] - Trogarzo® sales fell to $5,167,000 from $6,661,000, primarily due to lower unit sales [18] Recent Developments - The FDA approved EGRIFTA WR™ on March 25, 2025, which is expected to enhance the company's product offerings for treating excess visceral abdominal fat in adults with HIV [3][37] - The company resumed distribution of EGRIFTA SV® on February 14, 2025, following a temporary supply disruption due to a manufacturing shutdown [9][36] - The approval of the Prior Approval Supplement (PAS) for EGRIFTA SV® on April 7, 2025, allows for regular distribution without further FDA authorization [10][37] Research and Development - R&D expenses decreased by 21.2% to $2,969,000 in Q1 2025, attributed to lower spending on life-cycle management and oncology programs [22] - The company presented data at CROI highlighting the limitations of BMI in assessing cardiovascular risk in people with HIV [11] Guidance and Outlook - The company estimates FY2025 revenue to be between $80 million and $83 million, considering the impact of the supply disruption and the new product launch [13] - Adjusted EBITDA for Q1 2025 was $2,321,000, a significant improvement from a loss of $247,000 in the same period last year [28]
Theratechnologies Receives FDA Approval of Prior Approval Supplement (PAS) for EGRIFTA SV® sBLA
Newsfilter· 2025-04-08 11:00
Core Insights - The FDA has approved Theratechnologies' Prior Approval Supplement (PAS) for EGRIFTA SV®, allowing unrestricted distribution and removing previous supply uncertainties [1][2][3] - The new formulation, EGRIFTA WR™, has also been approved by the FDA and is set to replace EGRIFTA SV® in the U.S. market [2][3] Company Overview - Theratechnologies Inc. is a commercial-stage biopharmaceutical company focused on innovative therapies, particularly for HIV-related conditions [1][8] - The company aims to improve patient experience with the new EGRIFTA WR™ formulation, which is designed to be more convenient [3] Product Information - EGRIFTA SV® (tesamorelin for injection) is the only FDA-approved treatment for reducing excess abdominal fat in adults with HIV and lipodystrophy [1][3] - Tesamorelin acts as a growth hormone-releasing factor (GHRF) analog, stimulating the production and release of endogenous growth hormone [3] Regulatory Developments - The approval of the PAS eliminates the need for discretionary product release, enabling the company to resume regular distribution of EGRIFTA SV® [2] - The transition to EGRIFTA WR™ is anticipated to enhance patient compliance and overall treatment experience [3]
Theratechnologies to Announce First Quarter 2025 Financial Results and Provide Business Update
Newsfilter· 2025-04-03 20:30
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 ...
Theratechnologies CROI Presentation Highlights Limitations of Using BMI to Assess Cardiovascular (CV) Risk in People with HIV
Newsfilter· 2025-03-12 11:30
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]
Theratechnologies(THTX) - 2024 Q4 - Earnings Call Presentation
2025-02-26 18:29
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(THTX) - 2024 Q4 - Earnings Call Transcript
2025-02-26 18:21
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 ...
Theratechnologies(THTX) - 2024 Q4 - Annual Report
2025-02-26 13:32
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].
Theratechnologies(THTX) - 2024 Q4 - Annual Report
2025-02-26 13:30
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, ...
Theratechnologies Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2024
Newsfilter· 2025-02-26 12:30
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]