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].

Core Viewpoint - Theratechnologies Inc. has secured a $40 million three-year nondilutive, senior secured syndicated financing to optimize its capital structure and support its business development strategy, which is expected to free up approximately $19 million in cash by 2025 [1][2]. Financing Details - The new financing includes a $25 million senior secured term loan and a $15 million senior secured revolving facility, with an interest rate of SOFR plus 2.75%, significantly lower than the previous facility's rate of SOFR + 9.50% [2]. - The term loan will be amortized over seven years and matures on November 27, 2027, with $5 million already drawn from the revolving facility [2]. - Additionally, Investissement Québec will provide a $15 million second ranking secured subordinated term loan, with an interest rate currently set at US Government rates plus 7.23%, totaling 11.45% [3]. Financial Position - Post-financing, the company will have a total debt of $45 million and an estimated cash balance of approximately $20 million, resulting in a net debt position of about $25 million [4]. Strategic Implications - The financing is viewed as a critical milestone for the company's strategic focus on commercializing innovative therapies through business development deals and partnerships, enhancing profitability and strengthening the balance sheet for long-term growth [2].

Core Points - Theratechnologies Inc. has resubmitted its supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the FDA, aiming to simplify dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy [1][2] - The resubmission addresses concerns raised in the FDA's Complete Response Letter (CRL) issued in January 2024, which primarily focused on chemistry, manufacturing, and controls (CMC), as well as immunogenicity risk [2] - The FDA is expected to review the updated sBLA within four months, with a decision anticipated around the end of March 2025 [3] Product Information - EGRIFTA SV® (tesamorelin for injection) is currently approved in the U.S. for reducing excess abdominal fat in HIV-infected adult patients with lipodystrophy [4] - EGRIFTA SV® functions as a growth hormone releasing factor (GHRF) analog, stimulating the production and release of endogenous growth hormone [4] Company Overview - Theratechnologies is a biopharmaceutical company focused on developing and commercializing innovative therapies to address unmet medical needs [8]

Core Insights - Theratechnologies Inc. announced data highlighting the link between excess visceral abdominal fat (EVAF) and cardiovascular disease (CVD) risk in people with HIV, along with the potential of tesamorelin to mitigate this risk [1][2] VAMOS Study Findings - The VAMOS study, a multicenter observational study, found that 58% of participants with HIV had EVAF, with a mean visceral fat area of 148 cm² [2][4] - Higher EVAF was associated with increased 10-year atherosclerotic cardiovascular disease (ASCVD) risk and traditional risk factors such as insulin resistance and lipid levels [3][4] - A positive correlation was observed between EVAF and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores, as well as triglyceride:high-density lipoprotein (TG:HDL) ratios [2][3] Tesamorelin Impact on CVD Risk - Data from two phase 3 studies indicated that tesamorelin treatment led to a modest reduction in 10-year ASCVD risk scores, with an estimated change of -0.4% [5][6] - The reduction in CVD risk was more significant among participants with higher baseline risk, primarily driven by decreases in total cholesterol [5][6] - The study involved 543 participants, with 44% on lipid-lowering therapies, 37% on antihypertensive treatment, and 18% on diabetes medications [5]

Core Insights - Theratechnologies Inc. is conducting the PROMISE-US study to evaluate long-term clinical outcomes for heavily treatment-experienced individuals with HIV, focusing on the efficacy and safety of ibalizumab [1][3][4] Group 1: Study Design and Objectives - PROMISE-US is a phase 4, multicenter, observational study designed to assess the long-term efficacy and safety of ibalizumab-based regimens compared to other regimens in heavily treatment-experienced individuals [3][4] - The primary objective is to evaluate the long-term efficacy and durability of ibalizumab in combination with other antiretroviral therapies [4] - The study captures patient-reported outcomes such as satisfaction and adherence to treatment, making it the first real-world registry study for this patient population [3] Group 2: Participant Characteristics and Findings - As of November 2023, 114 participants were enrolled, with 70 in the control cohort and 42 receiving ibalizumab [5] - Participants receiving ibalizumab had higher viral loads (p = 0.0629) and declining CD4 T cells (p = 0.001) compared to those not on ibalizumab [5] - Ibalizumab was well tolerated, with no infusion reactions reported, and 80% of participants in the ibalizumab cohort remained on therapy for over 12 months [6] Group 3: Implications and Future Directions - The study aims to provide insights into the factors contributing to maintaining virologic response in heavily treatment-experienced individuals, addressing a significant unmet need in HIV treatment [7] - Theratechnologies is committed to analyzing data from PROMISE-US to understand the long-term safety and efficacy of ibalizumab, particularly in combination with long-term injectable therapies [7]

Financial Data and Key Metrics Changes - The company reported an adjusted EBITDA of $7.2 million and a net profit of $3 million for Q3 2024, demonstrating a significant turnaround [7][22] - Revenues for the quarter increased by 8% year-over-year, driven primarily by EGRIFTA SV, which saw a 27% increase in net sales compared to Q3 2023 [7][18] - The company revised its revenue guidance for 2024 to between $83 million and $85 million, while increasing adjusted EBITDA guidance to $17 million to $19 million [9][23] Business Line Data and Key Metrics Changes - EGRIFTA SV net sales reached $16.7 million in Q3 2024, up from $13.2 million in the same quarter last year, reflecting strong growth in enrollments and unique patients [18] - Trogarzo net sales decreased to $5.9 million in Q3 2024 from $7.7 million in the same quarter last year, attributed to competitive pressures [18][19] Market Data and Key Metrics Changes - The company noted that EGRIFTA SV has recorded its best performance in recent history, capturing patients and new prescribers at an unprecedented rate [7] - Despite challenges, Trogarzo sales have stabilized, and the company does not expect further declines in the upcoming year [8][19] Company Strategy and Development Direction - The company is focused on commercializing innovative treatments and has adapted its cost structure to support this strategic pivot [6][10] - There is an emphasis on finding new products to market and entering partnerships, leveraging the company's experience with EGRIFTA and Trogarzo [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in avoiding patient-level impacts from supply constraints and anticipates making up for sales not recorded in Q4 2024 in early 2025 [11][12] - The company is optimistic about the resubmission of the F8 formulation of Tesamorelin to the FDA by the end of November [13] Other Important Information - The company is preparing for a potential drug shortage by managing inventory closely and has multiple manufacturing slots scheduled [25][27] - The cash position at the end of Q3 2024 was approximately $39 million, indicating a strong financial footing [23] Q&A Session Summary Question: Can you provide any color on the remediation efforts being undertaken by the manufacturer? - Management confirmed ongoing discussions with manufacturers and expressed confidence in the timeline for resuming production [25][26] Question: Are you only looking at commercially available assets for new products? - The company is open to both in-licensing and acquiring drugs, focusing on compelling value propositions [31][32] Question: Do you plan on setting up a backup facility for EGRIFTA? - Management indicated that they do not plan to set up a backup facility but will build a solid inventory instead [32] Question: What is the expected timeline for the final data on TH1902? - The final analysis is expected towards the end of this year [35] Question: How will you ensure the sustainability of EBITDA and bottom line performance? - The current operating structure is deemed ideal for sustaining growth without additional costs [39]

Three- and nine-month periods ended August 31, 2024 and 2023 (Unaudited) THERATECHNOLOGIES INC. Table of Contents (In thousands of United States dollars) (Unaudited) Exhibit 99.1 | | Page | | --- | --- | | Interim Consolidated Statements of Financial Position | 1 | | Interim Consolidated Statements of Comprehensive Income (Loss) | 2 | | Interim Consolidated Statements of Changes in Equity | 3 | | Interim Consolidated Statements of Cash Flows | 4 | | Notes to Interim Consolidated Financial Statements | 5 - 2 ...

Core Insights - Theratechnologies Inc. is set to present three posters at IDWeek 2024, focusing on innovative therapies for HIV-related health issues [1][3] Group 1: Poster Presentations - One poster will discuss the link between excess visceral abdominal fat (EVAF) and increased cardiovascular risk in individuals with HIV [2] - Another poster will present findings on how tesamorelin, a growth hormone-releasing factor analog, can reduce EVAF and lower cardiovascular disease risk in HIV patients [2] - A third poster will outline the study design and baseline characteristics of the PROMISE-US trial, which examines the outcomes of multidrug-resistant HIV patients treated with ibalizumab [2][4] Group 2: Event Details - IDWeek 2024 will take place from October 16-19 in Los Angeles, California, and is a significant meeting for professionals in infectious diseases [1][4] - The presentations will occur on October 17, 2024, during sessions focused on HIV complications and treatment [4] Group 3: Company Overview - Theratechnologies is a biopharmaceutical company dedicated to developing and commercializing innovative therapies that address unmet medical needs [5]