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Theratechnologies Inc. (symbol: THTX) is a biopharmaceutical company that markets prescription products across the United States, Europe, and Canada. Founded in 1993 and headquartered in Montreal, Canada, the company is dedicated to addressing the unmet medical needs of patients living with HIV and other serious health conditions.
Core Products:
- EGRIFTA and EGRIFTA SV: These products help reduce excess abdominal fat in HIV-infected patients with lipodystrophy, improving their quality of life.
- Trogarzo: A vital injection treatment for multidrug-resistant HIV-1 infected patients, offering hope to those who have limited treatment options.
Pipeline Products:
- F8 Formulation: A promising treatment for HIV-associated lipodystrophy, currently in development.
- TH-1902: A potential breakthrough in the treatment of triple-negative breast cancer.
- TH-1904: Targeting ovarian cancer, another pipeline product with significant potential.
Theratechnologies generates significant revenue from its relationship with RxCrossroads, a major customer based in the United States. The company's strategic partnerships and innovative products showcase its commitment to improving patient outcomes in serious medical conditions. With a dedicated focus on research and development, Theratechnologies continues to make strides in the biopharmaceutical industry.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) presented data at IDWeek 2024 highlighting the impact of excess visceral abdominal fat (EVAF) on cardiovascular disease (CVD) risk in people with HIV (PWH). Two studies were presented:
1. The VAMOS study showed that EVAF is prevalent (58%) in PWH on modern anti-retroviral therapy (ART) and is associated with higher CVD risk factors and 10-year ASCVD risk.
2. An analysis of tesamorelin phase 3 studies demonstrated that tesamorelin-induced EVAF reduction may lower CVD risk in PWH, particularly in those with higher baseline risk.
These findings suggest that EVAF is an overlooked CVD risk factor in PWH, and tesamorelin may help reduce this risk by lowering EVAF.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) unveiled the study design and baseline characteristics of the PROMISE-US trial, focusing on ibalizumab in heavily treatment-experienced (HTE) people with HIV and multidrug resistance. The study aims to assess long-term clinical outcomes and factors contributing to virologic control. Key findings include:
1. Ibalizumab was more frequently selected for patients with lower CD4 counts and higher viral loads.
2. Most subjects on ibalizumab remained on therapy for over 24 months.
3. The study enrolled 114 participants: 70 in Cohort 1 (non-ibalizumab), 42 on ibalizumab (Cohort 2), and 2 screen failures.
4. Ibalizumab use was associated with higher viral loads (p = 0.0629) and declining CD4 T cells (p = 0.001).
5. 80% of Cohort 2 participants remained on ibalizumab for over 12 months.
6. No infusion reactions were reported, indicating good tolerability.
Theratechnologies reported strong Q3 2024 financial results with revenue of $22.6 million, up 8% year-over-year. The company achieved positive net income of $3.1 million or 6 cents per share, and Adjusted EBITDA of $7.2 million. EGRIFTA SV® sales grew 26.6% to $16.7 million, while Trogarzo® sales declined 22.9% to $5.9 million. The company revised its fiscal 2024 revenue guidance to $83-$85 million due to potential EGRIFTA SV® supply constraints, but increased Adjusted EBITDA guidance to $17-$19 million. Theratechnologies ended Q3 with $34.7 million in cash and $4.2 million in bonds/money market funds. The company faces some uncertainty around EGRIFTA SV® manufacturing and FDA approval timelines but expects to resume distribution in early 2025.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company, has announced it will report financial results and provide a business update for its third quarter ended August 31, 2024, on Thursday, October 10 at 8:30 a.m. ET. The conference call will be hosted by Paul Lévesque, President and CEO, joined by other management team members including Philippe Dubuc, Christian Marsolais, and John Leasure.
Participants are encouraged to join the call at least ten minutes in advance. The webcast link and dial-in information have been provided. A replay of the call will be available until October 17, 2024, with toll-free and international dial-in numbers provided. An archived webcast will also be available on the Company's Investor Relations website under 'Past Events'.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) announced a potential temporary supply disruption for EGRIFTA SV® in early 2025 due to its contract manufacturer's voluntary shutdown following an FDA inspection. The company is implementing measures to manage inventory levels until early January 2025, estimating a US$1.6 million shortfall in EGRIFTA SV® revenue for fiscal year 2024. Despite this, Theratechnologies remains confident in avoiding patient impact and delivering strong Adjusted EBITDA for the current fiscal year.
The manufacturer plans to resume activities by mid-October, with EGRIFTA SV® production scheduled for October 21, 2024. Theratechnologies must file a Prior Approval Supplement (PAS) with the FDA to resume distribution, which typically takes four months for review. The company will provide further updates on material developments.
Theratechnologies, a biopharmaceutical company (TSX: TH, NASDAQ: THTX), announced its participation in two investor conferences this September. President and CEO Paul Lévesque will present at both events:
1. H.C. Wainwright 26th Annual Global Investment Conference (Sept. 9-11, 2024) at Lotte New York Palace Hotel. A virtual presentation will be available to attendees on Sept. 9.
2. 2024 Cantor Global Healthcare Conference (Sept. 17-19, 2024) at InterContinental Barclay Hotel, New York. Lévesque will participate in a fireside chat on Sept. 18 from 8:00-8:30 a.m. ET.
The management team will be available for one-on-one meetings during both conferences, providing opportunities for investors to engage directly with the company.
Theratechnologies reported a strong second quarter for fiscal 2024, with revenue reaching $22 million, a 25% year-over-year increase. The company achieved a positive net income of $1 million and an Adjusted EBITDA of $5.5 million. For the full fiscal year 2024, Theratechnologies affirmed its revenue guidance between $87 million and $90 million, with Adjusted EBITDA projected between $13 million and $15 million.
EGRIFTA SV® sales saw a significant rise of 49.3% year-over-year, whereas Trogarzo® sales dropped by 13.1%. The company has also progressed in its oncology pipeline, completing the recruitment for the second cohort of a Phase 1 trial for sudocetaxel zendusortide.
Recently, Theratechnologies reorganized its preclinical oncology research activities and presented promising Phase 1 data at the ASCO 2024 meeting. General and administrative expenses and selling expenses saw reductions, contributing to improved financial performance. The cash position as of May 31, 2024, was $36.03 million, providing sufficient liquidity for the next 12 months.
Theratechnologies, a biopharmaceutical company, announced it will report its financial results and provide a business update for the second quarter ending May 31, 2024. The announcement will be made on July 10, 2024, at 8:30 a.m. ET. The call will be hosted by President and CEO Paul Lévesque, alongside other members of the management team including CFO Philippe Dubuc, CMO Christian Marsolais, and Global Commercial Officer John Leasure. Participants are encouraged to join the call early. Dial-in and replay information is available for interested parties.
Theratechnologies announced promising Phase 1 data for its investigational drug, sudocetaxel zendusortide, at the 2024 ASCO annual meeting.
The drug showed long-term disease stabilization in patients with solid tumors, lasting up to 45 weeks even after treatment ceased.
The study highlighted a unique, multimodal mechanism of action and a favorable safety profile. Notably, 44% of the female cancer patients achieved a clinical benefit rate.
The company is now moving into Part 3 of the Phase 1 trial, focusing on dose optimization.
Theratechnologies Inc. held its annual meeting of shareholders, where candidates for the Board of Directors were elected and KPMG LLP was appointed as auditors. The voting results showed high support for all candidates, with Frank Holler becoming the new Chair of the Board.
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