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Marketing and Distribution Agreement

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Presentation on theme: "Marketing and Distribution Agreement"— Presentation transcript:

1 Marketing and Distribution Agreement
for Ibalizumab March 18, 2016

2 Forward-Looking Statement
The following presentation contains statements that are considered forward-looking information (“FLI”) within the meaning of securities regulation which statements may contain such words as “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions. The FLI in this presentation relates to future events or future performance. The FLI are based on a number of assumptions and are associated with a number of risks, uncertainties and other unknown factors that may cause actual results, levels of activity, performance or achievements to be materially different from those implied by the FLI. Such FLI reflects our current views with respect to future events and is given as at March 18, We undertake no obligation and do not intend to update or revise the FLI contained in this presentation, except as required by law. Certain assumptions made in preparing the FLI include, but are not limited to, the following: (1) Ibalizumab will be approved by the FDA; (2) the timelines to complete the Phase III trial, the filing of the BLA, the issuance of the decision by the FDA and the launch of the product are accurate; (3) the assessment of the patient population is accurate; (4) Ibalizumab will be accepted by physicians and patients as a new treatment; and (5) revenues generated from the sale of Ibalizumab will grow our business and create shareholders value. The risks and uncertainties associated with the FLI include, but are not limited to, the risk that (i) the Phase III trial does not generate positive data; (ii) the FDA does not approve Ibalizumab; (iii) delays occur in completing the Phase III trial, the filing of the BLA, the issuance of the decision by the FDA and/or the launch of the product; (iv) if approved, the marketplace does not accept Ibalizumab as a new treatment; (v) we are unable to generate enough revenues from the sale of this product to cover our expenses. The FLI in our presentations may not materialize; accordingly, investors should not place undue reliance on it. For additional risks about Theratechnologies, we refer you to the “Risk Factors” section of our Annual Information Form dated February 24, 2016 available at and EGRIFTA® is a registered trademark of Theratechnologies Inc.

3 Marketing and Distribution Agreement
for Ibalizumab Luc Tanguay, President and CEO

4 Announcement summary Exclusive Marketing & Distribution Agreement for Ibalizumab in the United States and Canada Mutually beneficial Both organizations will continue to focus on their respective expertise Transaction will create value for both organizations Ibalizumab fits perfectly within our infrastructure HIV infected patients, as for EGRIFTA® Same treating physicians as EGRIFTA® Niche product Primary indication market size could be comparable to EGRIFTA® Breakthrough therapy designation from the FDA To treat serious or life threatening condition Substantial improvement over existing therapies 12-year exclusivity granted by the FDA Priority review status granted by the FDA

5 Announcement summary If approved, Ibalizumab will generate revenues in the short term (12-15 months) Optimization of existing sales and marketing infrastructure Increased field presence to also benefit EGRIFTA® Deal structure based on sales results and commercial success Reasonable upfront and milestone payments Top-line revenue sharing arrangement

6 Product overview Ibalizumab is a novel HIV entry inhibitor
First humanized monoclonal antibody to treat HIV Blocks the internalization of the virus in the cell First drug to bind to Domain 2 of the CD4 receptor

7 Product overview Target Population
Patients living with multi-drug resistant HIV-1 Administered intravenously (IV), twice a month Twice-monthly intramuscular (IM) injection formulation in development Once per month IM formulation also in development All formulations are covered by the agreement Orphan drug designation by the FDA Breakthrough therapy designation by the FDA Priority review granted status by the FDA Biologics License Application (BLA) expected to be filed in Q4 2016 Decision could be as early as first half of 2017 due to priority review granted by the FDA

8 Phase III Trial Phase III trial underway Open label
30 patients (more than two thirds of patients enrolled and having received treatment to date) Patient screening for the study anticipated to close later this month 24-week study First dose at Day 7 Primary endpoint: Percentage of patients achieving > 0.5 log decrease in viral load at day 14 (one week after treatment) Secondary endpoint at week 24: Validation of sustained efficacy and safety

9 Clinical Results to date
Ibalizumab has been the subject of 4 Phase I and II clinical trials Cumulative results Safety Ibalizumab is safe and well tolerated Used in 247 patients (some for up to 4 years) No drug-related significant adverse events Not CD4+ cell depleting and not immunogenic Efficacy Significant viral load reduction (greater than 1.0 log10) with single doses Durable viral load reductions] Increased CD4+ T cell count, multiple dose studies bi-weekly and monthly doses PK Elimination of Ibalizumab is saturable and dose-dependant Bi-weekly or monthly doses feasible

10 End of Phase III Recruitment
Expected timeline Q1 2016 Q3 2016 Q4 2016 Q2 2017 Q3 2017 End of Phase III Recruitment End of Phase III Trial FDA Filing FDA Decision(1) Product Launch (1) Priority review status is usually completed within 6 months

11 Market FDA orphan drug designation based on estimated patient population of 38,000 Initial indication patient population between 8,000-10,000 Treatment experienced Documented resistance Detectable viral loads Additional patient populations Patients intolerant to anti-retroviral therapy Patients on therapy who become non-compliant

12 Commercialization EGRIFTA® and Ibalizumab to be detailed by the same dedicated sales force Both products to receive support from our Medical Science Liaison Team Leverage our specialized call center for interactions with HIV healthcare professionals Specialty distribution model for both products Reimbursement handled by our Managed Markets Team

13 Competition HIV infected patients live longer and can become resistant to multiple drug classes Recently approved drugs with new mechanisms of action have limitations that Ibalizumab overcomes Development of resistance Drug interactions Cross-resistance Twice-daily dosing Injection site reactions Expensive testing required

14 Proposed Collaboration
TaiMed remains the product sponsor with the FDA Responsible for all pre-approval clinical trials Will continue to develop new formulations Will conduct Phase III trials for label expansion TaiMed will be responsible for manufacturing Theratechnologies will buy finished product at specified transfer price from TaiMed Theratechnologies will be the BLA holder and will be responsible for all aspects of commercialization

15 Financial aspects TaiMed to receive 52% of net sales
Theratechnologies to keep 48% of net sales Upfront payments and milestones US$2 million upon execution, US$1 million in cash, and US$1 million in common shares of Theratechnologies being priced at signature and to be issued upon commercial launch of Ibalizumab US$8,5 million at launch US$3 million in common shares of Theratechnologies US$5,5 million based on net sales of the product

16 Financial aspects US$3 million at launch of the twice-monthly IM formulation US$7 million upon sales reaching US$20 million over four consecutive quarters Up to US$200 million for once-monthly intramuscular formulation targeting expanded patient population Upon label expansion based on phase III trial Specific amount based on potential additional sales Milestones paid at launch and upon achieving annual sales level up to US$1 billion

17 Conclusion Significant transaction for Theratechnologies
Deal respects our financial capacity Product portfolio expansion with minimal risk Highly complementary product Deal leverages our existing infrastructure Sustained focus on our core business Short-term new market product opportunity Positions Theratechnologies as a key player in niche HIV Ibalizumab and Egrifta® both address important medical needs for HIV patients Ibalizumab could represent a safe and effective option in a patient population in dire need Perfect fit between our two companies

18 Question period for analysts
Marketing and Distribution Agreement for Ibalizumab March 18, 2016 Question period for analysts


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