Theratechnologies Inc Stock Price, News & Analysis

Theratechnologies has resubmitted its supplemental Biologics License Application (sBLA) to the FDA for the F8 formulation of tesamorelin, addressing concerns raised in January 2024's Complete Response Letter. The F8 formulation aims to replace EGRIFTA SV® with simplified dosing for treating excess abdominal fat in HIV patients with lipodystrophy. The FDA's previous concerns focused on chemistry, manufacturing and controls, and immunogenicity risk information. The FDA will review the updated application within four months, with a decision expected around March 2025. The new formulation is patent protected until 2033.

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.