Theratechnologies Inc. Common - THTX STOCK NEWS

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.

Theratechnologies will present long-term efficacy, safety, and pharmacokinetic data on the use of TH1902 in solid tumors at the 2024 ASCO Meeting. The presentation will focus on the Phase 1 clinical trial of sudocetaxel zendusortide in patients with cancers that have high SORT1 expression. Part 3 of the trial in advanced ovarian cancer is ongoing, providing valuable insights into the novel peptide-drug conjugate.