THERF updates

This post is to update you on recent Thera events.

  1. On May 1 they announced that the FDA released them from an obligation to conduct post-approval clinical studies for EGRIFTA (drug was approved in 2010 with a requirement to conduct post-approval trials later). Thera estimates this results in US$13 million in savings.

  2. On May 3 the CEO and CFO presented at the Bloom Burton Healthcare Investor Conference in Toronto. Maybe somebody like what they heard as the stock jumped 11% the next day.

  3. In the 12th may edition of Journal les affaires the CEO gave an interview saying he expects Trogarzo sales to reach US$500 million per year within 4-5 years. The paper requires a subscription and is in French. So I can only provide this translation made by a poster on a non-Fool board:

“The impact on the company’s business will be such that the President and CEO, Luc Tanguay, ensures that the revenue generated by Trogarzo’s sales will eventually be 10 times greater than the revenues generated by the company’s other commercialized drug, Egrifta.

The new flagship drug of the Montreal company and developed by TaiMed Biologics, a Taiwanese company listed on the Taipei Stock Exchange. But since it has no commercial activity, Theratechnologies has acquired the distribution rights. Everything should be in place to start marketing the drug in the month of May, and sales are expected to reach about $ 500 million in four or five years in the United States. In 2017, Theratechnologies sales totaled $ 42.9 million. In two years, the firm intends to tackle the European market.”

Maybe someone liked what they read since next trading day the stock jumped 13%. The AGM meeting is today and it would be nice if someone asked him to confirm this report. But we might just get “Things are looking good for the Trogarzo launch” and little else.

  1. Thera added to MSCI Global Small CAP Indexes, to take place as of close of May 31.…

  2. Maybe related to its addition to the index, Artisan International Small Cap Fund opened a 1% position with a purchase of 670,694 shares in Q1.

  3. In May the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH) in the United States awarded a grant to the Massachusetts General Hospital to conduct a study using EGRIFTA® in non-HIV patients suffering Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatosis Hepatosis (NAFLD-NASH). That was a mouthful :-)This could (someday if the study results are good, if they can gain a patent for this particular application, etc., etc.) widen application for their drug outside of HIV.

  4. Approvals by insurance companies continue. Approved by Medicare and a number of states for Medicaid. Some formularies closely adhere to the clean FDA label (good), while some have requirements beyond the FDA label (bad).

So I’m still quite bullish on Thera and look forward to the AGM and especially the next two quarterly results.


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From the AGM today:…

MONTREAL, May 16, 2018 (GLOBE NEWSWIRE) – Theratechnologies Inc. (TSX:TH) today disclosed, during its annual meeting, information on the number of scripts and reimbursement coverage for Trogarzo™ in the United States.

“We are quite pleased with the reaction from patients, physicians and payers since we announced the commercial availability of Trogarzo™ on April 30, 2018,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. “It did not take long to observe strong interest from HIV clinics and to obtain reimbursement from public and private payers,” added Mr. Tanguay.

“Major private insurers such as Cigna, Aetna, United Healthcare and Kaiser Permanente have already amended their reimbursement policy to include Trogarzo™. As we stand, about 25% of privately insured lives in the U.S. now have access to Trogarzo™. In addition, Medicare has quickly made it possible to approve individual requests. Medicaid coverage has been secured in California and Florida, among others, which, together, represent close to 20% of patients covered under Medicaid state plans. All this happened just two months after approval,” said Mr. Tanguay.

“While symbolic, we will reach the 100 prescription milestone within three weeks of commercial availability, which is reason to be optimistic about the demand for Trogarzo™,” added Mr. Tanguay.

“Our entire team continues to work very hard to quickly bring this unique product to patients faced with the challenge of multidrug resistant HIV,” concluded Mr. Tanguay.

Sounds good to me. An attendee at the meeting says Tanguay told him after the meeting that he would give updates on the number of patients for the next 12 months but then just report earnings. Giving the patient numbers is important because it takes a while for reimbursement.