INVESTOR PRESENTATION

Transcription

1 INVESTOR PRESENTATION May 2018

2 2 FORWARD-LOOKING INFORMATION The following presentation contains statements that are considered forward-looking information ( FLI ) within the meaning of securities regulation. The FLI in this presentation relates to future events or our 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 our 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 May 8, 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) our promotional activities and increased presence within the medical and scientific communities will increase our patient base in the United States and continue to grow EGRIFTA sales by 10-15% in fiscal 2018; (2) the long-term use of EGRIFTA will not change its known safety and efficacy profile; (3) our relations with our suppliers of services will be conflict free; (4) data on the size on the potential market for multidrug resistant HIV-1 patients are accurate; (5) Trogarzo TM will be reimbursed in the United States by third party payers; (6) we will be able to find and enter into agreements with third parties to in-license or acquire other products; (7) our current and future income will be sufficient to fund our business plan; and (8) our strategies and business plan will not be substantially modified. The FLI in our presentations may not materialize; accordingly, investors should not place undue reliance on it. We refer you to the Risk Factors section of our Annual Information Form dated February 6, 2018 available at and at for a description of the risks involved in the conduct of our business. EGRIFTA is a registered trademark of Theratechnologies Inc. Trogarzo is a trademark of TaiMed Biologics, Inc. under license to Theratechnologies Inc.

3 3 THERATECHNOLOGIES At a glance Founded in Montreal in 1993 Publicly traded on the TSX Experienced management and board of directors Financial M&A Pharmaceutical Commercial Regulatory Corporate governance

4 4 THERATECHNOLOGIES At a glance Evolved from biotech to specialty pharmaceutical company Focus on HIV niche products Mostly overlooked by big pharma Smaller patient population not suited for large-scale infrastructure Growth strategy Focus on existing assets Significant commercial potential Geographic expansion to Europe Product or license acquisitions Optimize sales force through addition of other HIV-related treatments

5 5 OUR APPROVED PRODUCTS Focusing on HIV niche markets Trogarzo TM (ibalizumab-uiyk) injection Approved by the FDA on March 6, 2018 Indicated for the treatment of patients with multidrug resistant HIV-1 First in a new class of antiretrovirals (CD4-directed post-attachment HIV-1 inhibitors) Commercial rights acquired for U.S.A., Europe and Canada from TaiMed Biologics Significant market potential EGRIFTA (tesamorelin for injection) Only treatment approved for HIV-associated lipohypertrophy FDA approval in 2010 Also approved in Canada and Mexico Commercialized in the U.S. and Canada by Theratechnologies 2017 net sales of CAD$ 42.9 million

6 6 Corporate and commercial structure Optimal patient and physician reach FUNCTIONS Head office (Canada) 30 Sales team (U.S.) 41 Reimbursement team (U.S.) 5 Medical Science Liaison (U.S.) 6 Call center (U.S.) 9 Total 91 Complementary products maximize effectiveness Dedicated team with focus on our portfolio Supply chain well structured for both products Optimal tax structure to benefit from our NOLs

7 7 Trogarzo Breaking new grounds in HIV Indicated for patients with multidrug resistant HIV-1 First HIV treatment with a new mechanism of action in over 10 years Breakthrough Therapy and Orphan Drug designations by the FDA First non-daily treatment in HIV (once every two week infusion) First biologic in the treatment of HIV First monoclonal antibody in HIV Regulatory exclusivity in the U.S. until March 2030

8 8 Trogarzo U.S. Potential Market* for Multidrug Resistant HIV-1 US HIV infected population 1.2 million US MDR HIV population K US HIV treated population K * EU patient population is of similar size Annual population requiring new treatment K

9 9 Trogarzo Efficacy profile Clinical program included 292 patients Open-label Phase III trial Primary endpoint 0.5 log 10 reduction in viral load after 7 days Results 82.5% success rate (33/40, p<0.0001) Average viral load reduction was 1.1 log 10 after 7 days Secondary endpoint results Mean reduction in viral load was 1.6 log 10 at week 25 43% of patients achieved undetectable viral load (<50 copies/ml) with a mean reduction of 3.1 log 10

10 10 Trogarzo Safety profile Generally well tolerated during clinical trial program Most common drug-related adverse reactions (incidence 5%) Diarrhea (8%) Dizziness (8%) Nausea (5%) Rash (5%) No cross-resistance No drug-to-drug interaction More information on Trogarzo TM is available at

11 11 Trogarzo Launch plan Trogarzo is now available to patients in the United States Commercially launched on April 30, 2018 Sales force fully trained Started detailing to physicians on April 2 nd Work diligently with public and private payers to ensure timely reimbursement Minimize patient access hurdles Patient assistance program Co-pay program Rebates to public payers Integrated distribution system

12 12 EGRIFTA Product key features: Only FDA approved treatment for the reduction of visceral adipose tissue (VAT) in HIV patients with lipodystrophy Condition easy to diagnose Demonstrated efficacy and safety Most common side effects include: joint pain, pain in legs and arms, swelling in your legs, muscle pain, tingling, numbness and pricking, nausea, vomiting. More information on Product addresses condition affecting 15,000 patients in the U.S. alone Sales reached CAD$ 42.9 million in % sales growth expected in % growth reported in Q Significant gross margin to support growth initiatives

13 13 MOVING FORWARD Growth strategy Successfully launch Trogarzo in the U.S. Ensure rapid market acceptance Timeframe of 4-5 years to reach peak sales Grow EGRIFTA revenues Build on expanded sales team Provides predictable cash inflows Obtain approval for Trogarzo in Europe Filing will proceed with US FDA regulatory packaged, as discussed with EMEA Expand product portfolio Product acquisitions In-licensing agreements

14 FINANCIAL INFORMATION

15 15 TAIMED PARTNERSHIP Financial structure highlights North American Agreement European Agreement Date of agreement March 18, 2016 March 6, 2017 Term 12 years from FDA approval 12 years from approval (country-bycountry basis) Transfer Price 52% of Net Sales 52% (57% of annual sales exceeding US$50M in European Territory) Payment at signature US$1M (cash) US$3M (common shares) Upfront and launch milestone Development milestones Commercial milestones US$4M (common shares) US$5.5M (cash payable through an increase in transfer price) US$3M (Intramuscular administration approval) Up to US$207M upon reaching various sales levels (up to US$1B) and label expansion objectives US$5M (cash payable one year after launch) US$5M (cash payable once EU sales reach US$50M) 50% of European clinical trial costs (if any) Up to US$80M upon reaching various sales levels (up to US$1B)

16 16 EGRIFTA REVENUES (in 000 CA$) Since regaining commercial rights 60,000 50, % 40,000 30,000 20,000 10,000, E

17 17 ANNUAL RESULTS 10 EBITDA (in millions of CA$) * EBITDA *2014 results reflect investment made to relaunch EGRIFTA in the U.S. *2017 results reflect investment made to prepare TROGARZO launch in the U.S.

18 18 FINANCIAL HIGHLIGHTS Solid cash position - CA$ 32.5 million at February 28, 2018 Balance of payment on EGRIFTA repurchase US$4 million due May 1, 2019 (US$4 million repaid on May 1, 2018) Non-interest bearing Market cap = ± CAD$ 825 million Share capital outstanding 75 million common shares 2.3 million options outstanding

19 19 CONCLUSION Theratechnologies is poised for significant growth over the short, mid and long term EGRIFTA sales to continue growing 10-15% in 2018 Trogarzo addressable market is between 20 to 25,000 patients in the U.S. alone Significant market opportunity for Trogarzo in Europe Product acquisition and/or in-licensing to provide additional momentum and further infrastructure optimization

20 THANK YOU