Theratechnologies Inc. operates as a biopharmaceutical company. The company focuses on the development and commercialization of innovative therapies addressing unmet medical needs. The company commercializes two approved products for people living with HIV, namely: EGRIFTA SV and Trogarzo. In addition to the sale of its products, the company is conducting research and development activities and it has a pipeline of investigational medicines in the areas of oncology and NASH.
Strategy
The compa...
Theratechnologies Inc. operates as a biopharmaceutical company. The company focuses on the development and commercialization of innovative therapies addressing unmet medical needs. The company commercializes two approved products for people living with HIV, namely: EGRIFTA SV and Trogarzo. In addition to the sale of its products, the company is conducting research and development activities and it has a pipeline of investigational medicines in the areas of oncology and NASH.
Strategy
The company's business strategy is to develop a portfolio of complementary products, compatible with its expertise in drug development and its commercialization know-how.
Products and Pipeline
EGRIFTA SV
Tesamorelin is the active peptide comprising EGRIFTA SV. Tesamorelin is a stabilized 44 amino acid human growth hormone-releasing factor analogue (GRF). The company's long-acting peptide method is a peptide stabilization process which increases the target protein's resistance to enzymatic degradation, while maintaining its natural specificity. This usually results in a more stable and efficient compound, which can thus prolong its duration of action. Tesamorelin induces growth hormone secretion in a natural and pulsatile way. The clinical results obtained to date using tesamorelin suggest a therapeutic potential in both anabolic and lipolytic indications. Tesamorelin for injection induces the release of growth hormone which causes a reduction in excess visceral abdominal fat (lipohypertrophy) in HIV-infected adult patients without reducing or interfering with subcutaneous fat, and, as such, has no clinically significant effect on undesired loss of subcutaneous fat (lipoatrophy).
EGRIFTA SV (tesamorelin for injection) is a new formulation of EGRIFTA, which was originally approved by the FDA in 2010 and was launched in the United States in 2011. EGRIFTA SV was approved by the FDA in 2018, was launched in 2019 and has replaced EGRIFTA in such country. EGRIFTA SV can be kept at room temperature, comes in a single vial and has a higher concentration resulting in a smaller volume of administration. EGRIFTA SV is the only approved therapy in the United States for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. We have been commercializing this product in the United States since May 1, 2014.
Lipodystrophy
Lipodystrophy is characterized by abnormalities in the production and storage of fat. It has two components: lipohypertrophy, and excessive abdominal fat accumulation, and lipoatrophy, the noticeable, localized loss of fat tissue under the skin. In patients with lipohypertrophy, fat accumulation occurs mostly around the waist and may also occur in other regions, including breast tissue and in dorsocervical tissues in the neck, resulting in a buffalo hump. Excess fat also appears as lipomas, or benign tumors composed of fat cells. In patients with lipoatrophy, the loss of fat tissue generally occurs in the limbs and facial area.
Trogarzo (ibalizumab-uiyk)
Trogarzo (ibalizumab-uiyk) is a CD-4 directed post-attachment HIV-1 inhibitor. Trogarzo was approved by the FDA on March 6, 2018, and was made commercially available in the United States on April 30, 2018. In the United States, Trogarzo is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with MDR HIV-1 infection failing their ARV regimen. Trogarzo was the first HIV treatment approved with a new mechanism of action. The treatment is administered every two weeks. It is a long-acting ARV therapy that can lead to an undetectable viral load in combination with other ARVs. Since its approval, Trogarzo was included in the treatment guidelines issued by the International Antiviral Society-United States and the treatment guidelines issued by the U.S. Department of Health and Human Services.
Trogarzo was also approved by the EMA in 2019 and is no longer under licence to the company in Europe further to its decision to terminate and return to TaiMed its commercialization rights to this product in April 2022.
Trogarzo was developed by TaiMed and pursuant to an amended and restated distribution agreement entered into on March 6, 2017 (TaiMed Agreement) the company has an exclusive license to commercialize this product in the United States and Canada.
Trogarzo is administered by intravenous infusion as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP. The Trogarzo loading dose can also be administered as an undiluted intravenous (IV) push over 90 seconds, and the maintenance dose can be administered as an undiluted IV push over 30 seconds.
Unlike other ARV agents, Trogarzo binds primarily to the second extracellular domain of the CD4 receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents the HIV virus from infecting CD4+ immune cells while preserving normal immunological function. Trogarzo ® is active across all major HIV clades and irrespective of tropism.
Life Cycle
On October 3, 2022, the FDA approved the 30-second IV Push method of administration for the maintenance dose of Trogarzo and on December 13, 2023, the FDA approved the IV Push administration of the loading dose of Trogarzo. IV Push is a method by which the undiluted medication is pushed by syringe for faster administration into the body's circulation and is designed to make Trogarzo administration easier and more convenient for people with HIV and their health care providers.
On October 13, 2023, the company announced results from a study evaluating the intramuscular (IM) method of administration of Trogarzo. This study (TMB-302), conducted in partnership with TaiMed, enrolled 21 subjects (7 HIV-positive and 14 HIV-negative) to assess the pharmacokinetics, efficacy, and safety of the IM administration of Trogarzo as compared to the IV infusion. Mean Trogarzo trough concentrations were greater than 15 µg/mL, suggesting that IM injection was sufficient at maintaining the drug trough concentration above the therapeutic level of 0.3 µg/mL.
The company has completed the study of the use of the IM method of administration of Trogarzo and on January 2, 2024, it announced the filing of a sBLA with the FDA seeking approval of the IM method of administration for maintenance doses of Trogarzo. The company is awaiting a Prescription Drug User Fee Act (PDUFA) date.
Research and Development Activities
In addition to the sale of its products, the company is conducting research and development activities. The company has established a promising pipeline of investigational medicines in areas of high unmet need, including oncology and NASH. In previous years, the company has also worked on extending the lifecycle of tesamorelin and ibalizumab-uiyk. With respect to the latter, the company improved the method of administration of both the loading dose and the maintenance dose by obtaining approval of an IV Push method of administration and it has filed a sBLA with the FDA seeking the approval of an IM method of administration of the maintenance dose.
Lifecyle Management of Tesamorelin in Lipodystrophy
F8 Formulation
On September 25, 2023, the company announced the filing of a sBLA with the FDA seeking the approval of the F8 Formulation. On January 23, 2024, the company received a CRL from the FDA. The company will address the FDA's questions and intends to pursue the approval of the F8 Formulation.
The F8 Formulation is eight times more concentrated than EGRIFTA and two times more concentrated than the F4 formulation sold under the trade name EGRIFTA SV. The company plans to withdraw EGRIFTA SV from the market if and when the F8 Formulation is approved by the FDA. The F8 Formulation can be kept at room temperature, comes in a single vial and has a higher concentration resulting in a smaller volume of administration than EGRIFTA SV. The F8 Formulation has the distinct advantage of requiring a single reconstitution per seven days of daily therapy.
Once approved, the F8 Formulation could be used in the company's proposed Phase 2b/3 clinical trial studying tesamorelin for the treatment of NASH in the general population.
EGRIFTA SV
Following the launch of EGRIFTA SV in the United States in 2019, the company received a number of complaints from patients relating to the reconstitution of EGRIFTA SV. In March 2021, the company proactively decided to submit to the FDA a CBE supplement to the IFU included in the EGRIFTA SV product labeling and, per the timelines set forth in the regulation. The company implemented these changes, which included an amended IFU. The company also provided patients with detailed training through its call center, THERA Patient Support, related to the changes. The FDA responded to the company's CBE supplement with a CRL asking it to carry out a HFS to ensure that patients reconstitute EGRIFTA SV in the proper manner. As of November 30, 2023, the company had completed the first part of the HFS, the formative study. The validation study remains to be conducted and the results thereof remain to be filed and accepted by the FDA. The company has until September 15, 2024, to submit the HFS results to the FDA. The company intends to apply for an extension of this deadline.
Multi -Dose Pen Injector
In 2021, the company began developing a device in the form of a pen for the administration of tesamorelin. This pen was intended to be used in conjunction with the F8 Formulation. To date, its development is not completed, and it has halted all activities in relation to the development of this device.
Tesamorelin for NASH in the General Population
On September 10, 2020, the company announced its intent to study tesamorelin for the potential treatment of NASH in the general population using the F8 Formulation. In November 2020, the company filed an Investigational New Drug Application (IND) with the FDA for a Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH and it received a Study May Proceed letter for such Phase 3 clinical trial from the FDA in December 2020.
The company continues to pursue potential NASH partners in the marketplace. The company continues to maintain that the further development of tesamorelin allows the company to keep its positioning as one of the few options for drug developers to immediately partner with a company in order to launch a Phase 2b/3 NASH clinical trial.
Oncology
SORT1+ Technology Platform
SORT1+ Technology is the name the company gave its platform that provides for the development of new proprietary peptides for cancer drug development targeting SORT1 receptors. SORT1 is a receptor that plays a significant role in protein internalization, sorting and trafficking.
In preclinical data, the company's lead investigational PDC, sudocetaxel zendusortide, derived from its SORT1+ Technology, has shown to improve anti-tumor activity and reduce neutropenia and systemic toxicity compared to traditional chemotherapy. Additionally, in preclinical models, sudocetaxel zendusortide has shown to bypass the multidrug resistance protein 1 (MDR1; also known as P-glycoprotein) and inhibit the formation of vasculogenic mimicry - two key resistance mechanisms to chemotherapy treatment. Sudocetaxel zendusortide combines the company's proprietary peptide and the cytotoxic drug, docetaxel.
The company acquired the SORT1+ Technology platform following the acquisition of all of the issued and outstanding shares of Katana BioPharma Inc. (Katana) on February 25, 2019 (Katana Agreement). Katana had the exclusive worldwide rights, through a royalty-bearing licence agreement entered into with Transfert Plus, LP (Transfert Plus), to a technology platform using peptides as a vehicle to specifically deliver cytotoxic agents to sortilin receptors, which are overexpressed on cancer cells (Transfert Plus License Agreement). Katana has since been wound up into Theratechnologies and we became a party to the Transfer Plus License Agreement.
Sudocetaxel Zendusortide Phase 1 Clinical Trial
In March 2021, the company initiated a Phase 1 clinical trial evaluating sudocetaxel zendusortide for the treatment of cancers where the sortilin receptor is expressed. The Phase 1 clinical trial design included a Part A dose escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumor activity of sudocetaxel zendusortide administered once every three weeks in patients with advanced solid tumors refractory to available anti- cancer therapies. Part B of the Phase 1 clinical trial, also known as the basket trial initially consisted in recruiting a total of approximately 70 patients to study the safety and tolerability of sudocetaxel zendusortide in the following various solid tumor types, including HR+ breast cancer, triple negative breast cancer, ovarian cancer, endometrial cancer, melanoma, thyroid cancer, small cell lung cancer, and prostate cancer. As per the study protocol, the MTD is established once a significant adverse event is observed in two or more patients.
Part A of the Phase 1 clinical trial was completed in the summer of 2022. The company then reported that a total of 18 heavily pre-treated patients, who received an average of eight prior cancer treatments, were enrolled in the dose escalation portion of the study. Following the safety observations at 420 mg/m2 including grade 3 neuropathy, grade 4 neutropenia, grade 3 ocular changes (visual acuity, keratitis and ocular surface dryness) and grade 2 skin toxicities (rash, pruritis and inflammation), the dose of sudocetaxel zendusortide was decreased to 300 mg/m2 for the next dose level and was expanded to a total of six patients.
In addition, the company reported that 300 mg/m 2 appeared to be a well-tolerated dose level. The company further reported the observation of signs of efficacy in three heavily pretreated patients.
In December 2022, after consulting with the company's investigators, it decided to voluntarily pause the enrollment of patients and revisit the study design of its clinical trial studying sudocetaxel zendusortide in various types of cancer.
Following the voluntary pause, the company formed a Scientific Advisory Committee to help determine the best developmental path forward for sudocetaxel zendusortide which led to the filing of an amended protocol with the FDA.
On June 2, 2023, the company announced the FDA's agreement to our amended Phase 1 trial protocol for sudocetaxel zendusortide following the submission of such amended protocol. The amended protocol is designed to improve the therapeutic window of sudocetaxel zendusortide and extend its duration of therapy. The amended protocol includes a change in the frequency of administration to weekly dosing and a narrowing of the patient population to focus on those with high-grade serous ovarian cancer, including high-grade peritoneal or fallopian tube cancer, or high-grade endometrioid cancer - a population in which preliminary efficacy has been observed thus far and has known high SORT1 expression.
Markets
EGRIFTA SV
EGRIFTA SV is solely commercialized in the United States and almost all of the company's revenues are generated from one customer, McKesson (as defined below). Prior to November 2019, the date on which EGRIFTA SV became commercially available in the United States, EGRIFTA was also commercialized in the United States and Canada. However, EGRIFTA is no longer offered for sale in the United States since being replaced by EGRIFTA SV in the 2020 fiscal year. The company also discontinued the sale of EGRIFTA in Canada in October 2022.
In November 2022, the company entered into an agreement with foreign distributors providing them with the exclusive right to distribute EGRIFTA SV under named patient programs only in various countries based in the regions of Latin America, Middle East, North Africa and Turkey and Central and Eastern Europe. In July 2023, the company also entered into an agreement with a foreign distributor providing it with the exclusive right to distribute EGRIFTA SV under named patient programs in various countries based in Western Europe, Nordic Region and the United Kingdom.
Trogarzo
Since the last fiscal year, Trogarzo is solely commercialized in the United States. For the fiscal years ended on November 30, 2022 and 2021, Trogarzo was also commercialized in certain European countries.
In Canada, the company is responsible, but under no obligation, to seek the approval of Trogarzo from Health Canada. No filing seeking the approval of Trogarzo has been made in Canada and to date, it is unlikely that a filing seeking the approval of Trogarzo in Canada will be made.
Prior to December 15, 2022, the TaiMed Agreement provided the company with the exclusive rights to commercialize Trogarzo in the European Union countries and in certain additional European countries (European Territory). Trogarzo was then commercially available in the European Territory through the company's European subsidiary, Theratechnologies Europe Limited, until December 15, 2022, the effective date on which all of its commercialization rights to Trogarzo were returned to TaiMed under the TaiMed Agreement. Since the company's decision to return to TaiMed its commercial rights to Trogarzo in the European Territory, we have ceased all activities related to the commercialization of this product in the various European countries in which such activities were ongoing. The EMA has since withdrawn the marketing approval of Trogarzo in Europe.
Manufacturing
EGRIFTA SV
The company relies on third-party service providers, i.e. Bachem and Jubilant to manufacture and supply all of its required raw materials, drug substance and drug product for sales of EGRIFTA SV. The company will rely on LSNE for the manufacture of the F8 Formulation if and when approved.
Active Pharmaceutical Ingredient
On July 31, 2023, the company signed a manufacturing and supply agreement with Bachem (Bachem Agreement) relating to the manufacture and supply of the active pharmaceutical ingredient of tesamorelin (API) for EGRIFTA SV.
Finished Product
The company has an agreement with Jubilant providing for the manufacture and supply of the finished form of EGRIFTA SV for commercial sale in the United States and for tesamorelin in connection with clinical trials (Jubilant Agreement). Under the Jubilant Agreement, Jubilant must fill vials with tesamorelin, lyophilize it, label and package those vials and deliver them to locations in accordance with the company's instructions.
The company has an agreement with LSNE, providing for the manufacturing and commercial supply of the F8 Formulation with an effective date of May 11, 2020.
The company also provides patients with the administration boxes which include the necessary supplies to administer the product. These administration boxes are consisting of alcohol swabs, syringes, needles and water for injection. The packaging of these administration boxes for EGRIFTA SV is done through Sharp Packaging Services, LLC (Sharp) and will be done through Almac Pharma Services LLC (Almac) for the F8 Formulation if and when approved.
Trogarzo
TaiMed is the company's sole supplier of Trogarzo. TaiMed has subcontracted the manufacture of Trogarzo to WuXi in China, and to Samsung, in South Korea.
Sudocetaxel Zendusortide
Active Pharmaceutical Ingredient
The company has an agreement with STA Pharmaceutical Hong Kong Limited (STA) providing for the manufacture of its peptide (TH19P01) and to produce sudocetaxel zendusortide.
Finished Product
The company relies on Piramal Pharma Solutions, Inc. (Piramal) to manufacture the finished form of sudocetaxel zendusortide as vials of sterile solution for injection. The vials are then shipped to Sharp Clinical Services, LLC, with whom the company has an agreement for the labelling and packaging of the vials for clinical trials.
Distribution Channels
EGRIFTA SV
In connection with the commercialization of its products in the United States, the company has entered into various agreements with third-party service providers to distribute its products to patients. The distribution of EGRIFTA SV is tightly controlled and is only available through certain selected pharmacies.
Logistics Service Provider and Distributor
In 2017, the company entered into an amended and restated master services agreement with RxC Acquisition Company, LLC, doing business as RxCrossroads by McKesson and subsequently assigned to McKesson Specialty Care Distribution LLC (McKesson) along with two amended and restated statements of work (collectively, McKesson Agreement). Under the terms of the McKesson Agreement, McKesson acts as the company's exclusive third-party logistics service provider for all of its products in the United States and as such, provides it with warehousing and logistical support services, including inventory control, account management, customers support, product return management and fulfillment of orders.
Under the McKesson Agreement, McKesson also acts as the company's exclusive third-party distributor of its products in the United States. In such role, McKesson purchases products from the company and takes title thereto. McKesson's purchases of the company's products are triggered by its expectations of market demand over a certain period of time. McKesson fulfills orders received from authorized wholesalers and certain authorized specialty pharmacies and, with respect to EGRIFTA SV, delivers it directly to that authorized wholesaler's client, namely a specialty pharmacy forming part of its network of specialty pharmacies, or directly to those authorized specialty pharmacies.
Wholesalers
The company's supply chain of EGRIFTA SV in the United States consists of a limited number of wholesalers through which specialty pharmacies it has contracted with can order EGRIFTA SV. These wholesalers accept purchase orders from those specialty pharmacies, purchase EGRIFTA SV from McKesson, and resell this product to these specialty pharmacies. The company's wholesalers do not handle the physical delivery of EGRIFTA SV. The shipping and delivery of EGRIFTA SV to those specialty pharmacies is handled by McKesson.
Specialty Pharmacies
The company has entered into agreements with various specialty pharmacies across the United States providing them with the right to order EGRIFTA SV from its authorized wholesalers and distribute EGRIFTA SV to patients in the United States through their networks of local pharmacies. In addition, a limited number of those specialty pharmacies are authorized to purchase EGRIFTA SV directly from McKesson for their own retail specialty pharmacy stores.
Trogarzo
Logistics Service Provider and Distributor
McKesson also acts as the company's exclusive third-party logistics service provider and exclusive third-party distributor for Trogarzo in the United States under the McKesson Agreements. Orders for Trogarzo are made directly by a limited number of specialty pharmacies and specialty distributors and delivery of Trogarzo is made directly to those specialty pharmacies and specialty distributors by McKesson.
Specialty Pharmacies and Distributors
The company has entered into agreements with specialty pharmacies, specialty distributors, and infusion therapy providers that have a large U.S. network capable of handling drug products whose administration is made intravenously. These specialty pharmacies and specialty distributors have the capacity to deliver Trogarzo to patients, physicians or infusion centers. Each of those specialty pharmacies and specialty distributors purchase Trogarzo from McKesson and deliver it to infusion centers, physicians or patients for home-infusion.
Marketing
The company's marketing and sales activities in the United States for EGRIFTA SV and Trogarzo are conducted from its head office in Montreal, Quebec, Canada. The company has also retained the services of Syneos Health (Syneos), a third party service provider, to assist it with market access and reimbursement activities in the United States. The market access and reimbursement teams provided by Syneos are solely dedicated to the company's products. Syneos is a recognized provider of services around the globe. The company has renewed its agreement with Syneos and it entered into an amendment to its amended and restated master service agreement in this respect effective as of December 1, 2021 (Syneos Agreement) pursuant to which Syneos will continue providing us with certain services in connection with the commercialization of EGRIFTA SV and Trogarzo in the United States until November 30, 2024.
The company has contracted with Asembia, LLC (Asembia) for the provision of services related, amongst other things, to a call center. The call center, THERA Patient Support, guides physicians and patients through the process of initiating treatment under reimbursement. This process, which can be complex and time-consuming, begins with a referral and concludes with the final reimbursement decision. THERA Patient Support also helps patients adhering to their treatment and answering questions about the company's products.
Intellectual Property
The company relies on multiple patents related to tesamorelin, the active ingredient of EGRIFTA SV in the United States and in other countries. For instance, the F8 Formulation is patent protected in the United States until 2033. The company also has additional patents in the United States covering tesamorelin for the treatment of NASH scheduled to expire in 2040. Moreover, the company's PDCs stemming from its licensed SORT1+ Technology platform is also patent protected in the United States and other countries and patent applications are pending in various countries.
Apart from the patents and trade secrets, the company relies on specific licensing agreements which are essential to maintain our commercial and R&D activities, namely:
The distribution and marketing agreement with TaiMed granting the company the exclusive right to market Trogarzo in Canada and in the United States.
The licensing agreement with Katana granting the company a worldwide exclusive license to use and develop the SORT1+ Technology Platform.
The licensing agreement with the Massachusetts General Hospital (MGH) for the development of tesamorelin for the potential treatment of NASH in the general population.
Government Regulations
The marketing of EGRIFTA SV and Trogarzo within the United States may also be subject to various federal and state laws pertaining to health care fraud and abuse, including but not limited to the federal Anti-kickback Statute, Civil Monetary Penalties Law, and False Claims Act and analogous state laws. Drug products must be manufactured and packaged in accordance, among other things, with GMP and both Bachem and Jubilant, the contract manufacturers of EGRIFTA SV, as well as WuXi and Samsung, the manufacturer of Trogarzo, must adhere to GMPs in connection with the manufacture, labeling, packaging, and any other quality-related functions for these products. The company's research and development activities are subject to GCPs.
Drug products must be manufactured and packaged in accordance, among other things, with GMP and both Bachem and Jubilant, the contract manufacturers of EGRIFTA SV, as well as WuXi and Samsung, the manufacturer of Trogarzo, must adhere to GMPs in connection with the manufacture, labeling, packaging, and any other quality-related functions for these products.
In the United States and in other countries, sales of EGRIFTA SV and Trogarzo will depend in large part on the availability of reimbursement from third-party payors. These payors include both government (such as Federal Medicare and State Medicaid, AIDS Drug Assistance Programs and special needs plans in the United States) and privately managed care organizations, as well as pharmacy benefit managers.
History
Theratechnologies Inc. was founded in 1993. The company was incorporated under Part IA of the Companies Act (Quebec) in 1993.
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