Decided to look up our nearest competitor for COMBO. They are starting to follow CYDY's playbook now. Moving forward with NAFLD/NASH and TNBC.
TaiMed ... currently US$1.09B market cap ... THTX is currently US$227M market cap ...
Cannacord Initiates Coverage for THTX with $12 PT (300%+ increase from current SP)
Generating cash in HIV, NASH is next in Phase III; initiating with a BUY and $12 PT
Growing stable of treatments in company's core area – HIV
Theratechnologies has two approved products on the market: Trogarzo for the treatment of multi-drug-resistant HIV-1 infection and Egrifta SV (tesamorelin) for HIV-associated lipodystrophy. Additionally, the company has requested a Type C meeting with the FDA to propose the overall design including endpoints for a Phase III registrational study for tesamorelin in HIV-associated non-alcoholic fatty liver disease (NAFLD) as well as non- alcoholic steatohepatitis (NASH).
Type C meeting with FDA key for 2020 NASH Phase III
It has only been a few years since the FDA proposed acceptable endpoints likely to demonstrate clinical benefit in Phase III studies for NASH. To date, only one company has completed a trial using these endpoints, which require ~2,000+ patients for proper powering. We believe Theratechnologies has a strong chance of getting the FDA to agree to a smaller 500-patient trial in HIV-associated NASH for the following reasons:
• HIV-associated NAFLD/NASH is orphan in size
• No current trials for NASH are looking at NASH in HIV
• HIV patients are at much higher risk for developing NASH • Tesamorelin has a >9-year commercial safety record
New formulation, Egrifta SV, launches in the U.S.
We believe second-generation Egrifta, Egrifta SV, has attributes that will spur longer usage of the drug and potentially grow the market. The new version comes as a single vial (SV), does not require cold-chain shipping or refrigeration by the end-user, and is four times more concentrated resulting in a much smaller dose, which aids in reducing injection pain. An additional financial advantage to the new formulation is an increased concentration, which translates into lower COGS.
Formulation improvement continues: F1 to F4, soon F8
While Egrifta SV has been launched for HIV-associated lipodystrophy, the company will conduct bioequivalence studies in 2020 for an F8 formulation, which is eight times more potent than original Egrifta. The F8 formulation will be implemented in the Phase III trial for HIV-associated NAFLD/NASH that will be discussed with the FDA. The even further reduction in volume would allow for once-weekly re-constitution and the potential for using an injector for administration.
Trogarzo sales continue to grow in multi-drug-resistant HIV
Trogarzo was first approved by the FDA in March 2018 and EMA in September 2019, and continues to demonstrate strong sales growth in a niche market of approximately 10K to 12K patients. While the market is small by patient numbers, sales are a different story with every 1,000 patients on drug translating to $100M in net sales.
TaiMed ... currently US$1.09B market cap ... THTX is currently US$227M market cap ...
Cannacord Initiates Coverage for THTX with $12 PT (300%+ increase from current SP)
Generating cash in HIV, NASH is next in Phase III; initiating with a BUY and $12 PT
Growing stable of treatments in company's core area – HIV
Theratechnologies has two approved products on the market: Trogarzo for the treatment of multi-drug-resistant HIV-1 infection and Egrifta SV (tesamorelin) for HIV-associated lipodystrophy. Additionally, the company has requested a Type C meeting with the FDA to propose the overall design including endpoints for a Phase III registrational study for tesamorelin in HIV-associated non-alcoholic fatty liver disease (NAFLD) as well as non- alcoholic steatohepatitis (NASH).
Type C meeting with FDA key for 2020 NASH Phase III
It has only been a few years since the FDA proposed acceptable endpoints likely to demonstrate clinical benefit in Phase III studies for NASH. To date, only one company has completed a trial using these endpoints, which require ~2,000+ patients for proper powering. We believe Theratechnologies has a strong chance of getting the FDA to agree to a smaller 500-patient trial in HIV-associated NASH for the following reasons:
• HIV-associated NAFLD/NASH is orphan in size
• No current trials for NASH are looking at NASH in HIV
• HIV patients are at much higher risk for developing NASH • Tesamorelin has a >9-year commercial safety record
New formulation, Egrifta SV, launches in the U.S.
We believe second-generation Egrifta, Egrifta SV, has attributes that will spur longer usage of the drug and potentially grow the market. The new version comes as a single vial (SV), does not require cold-chain shipping or refrigeration by the end-user, and is four times more concentrated resulting in a much smaller dose, which aids in reducing injection pain. An additional financial advantage to the new formulation is an increased concentration, which translates into lower COGS.
Formulation improvement continues: F1 to F4, soon F8
While Egrifta SV has been launched for HIV-associated lipodystrophy, the company will conduct bioequivalence studies in 2020 for an F8 formulation, which is eight times more potent than original Egrifta. The F8 formulation will be implemented in the Phase III trial for HIV-associated NAFLD/NASH that will be discussed with the FDA. The even further reduction in volume would allow for once-weekly re-constitution and the potential for using an injector for administration.
Trogarzo sales continue to grow in multi-drug-resistant HIV
Trogarzo was first approved by the FDA in March 2018 and EMA in September 2019, and continues to demonstrate strong sales growth in a niche market of approximately 10K to 12K patients. While the market is small by patient numbers, sales are a different story with every 1,000 patients on drug translating to $100M in net sales.
