Theratechnologies (TSX:TH)(NASDAQ:THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.
The company’s business strategy is to grow revenues from Theratechnologies’s existing and future assets in North America and Europe and to develop a portfolio of complementary products that are compatible with the company’s expertise in drug development and commercialization know-how.
Regulatory approvals
Currently, the company has two approved products — namely, EGRIFTA and Trogarzo in the United States, the European Union, and the United Kingdom. EGRIFTA was originally approved by the U.S. Food and Drug Administration (FDA) in November 2010 and was launched in the United States in January 2011.
Exclusive marketing
EGRIFTA can be kept at room temperature, comes in a single vial, and has a higher concentration resulting in a smaller volume of administration. The drug is currently the only approved therapy in the United States for the reduction of excess abdominal fat in human immunodeficiency virus (HIV) infected patients. EGRIFTA is also approved by Health Canada and was launched in Canada in June 2015.
In Canada, EGRIFTA is the only approved drug for the treatment of excess visceral adipose tissue, as assessed by high waist circumference in adult HIV-infected patients. EGRIFTA is marketed exclusively by the company in Canada and Mexico’s health agency has also approved the drug.
Benefitting from early-access programs
The company’s Trogarzo injection was approved by the FDA in March 2018 and was made commercially available in the United States. Trogarzo is also commercially available in Germany and in other countries through early access programs.
Trogarzo is the first HIV treatment approved with a new mechanism of action in more than 10 years. The treatment is infused every two weeks. It is the first in a new class of antiretrovirals (ARV), and is a long-acting ARV therapy that can lead to an undetectable viral load in combination with other ARVs.
Promising pipeline of investigational medicines
In addition to the sale of company’s products, Theratechnologies is also conducting research and development activities. The company has a promising pipeline of investigational medicines in the areas of oncology. Tesamorelin, the active ingredient in EGRIFTA, is designed to increase endogenous growth hormone secretion. Tesamorelin has a well-established safety profile, with more than 10 years of product history.
Robust business strategy
The company plans on initiating a phase-three clinical trial to study tesamorelin for the treatment of various types of cancers. Theratechnologies’s business strategy is focused on increasing sales of EGRIFTA and Trogarzo in the United States. Further, the company plan to launch Trogarzo in key countries of the E.U. and obtain reimbursements for the product.
Potential product acquisitions
Further, the company is beginning a phase-one clinical trial using Theratechnologies’s products in various types of cancers in the second quarter of 2021. The company is pursuing potential product acquisitions, in-licensing transactions, or other similar opportunities that are complementary to the company’s business. The company is also managing its financial position to ensure it can successfully execute business objectives. This could lead to a significantly higher stock price.
