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Corporate Presentation Fall 2015 Safe Harbor Statement Special - PowerPoint PPT Presentation

Corporate Presentation Fall 2015 Safe Harbor Statement Special Note Regarding Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All


  1. Corporate Presentation Fall 2015

  2. Safe Harbor Statement Special Note Regarding Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements with respect to expectations regarding the timing of discussions with the FDA and/or USDA and approval and licensure of products; development programs, clinical trials and studies, including without limitation the timing of full enrollment in and the announcement of results of such trials and studies; commercialization and manufacturing of products, including without limitation establishing larger manufacturing capacities for AT-004 and AT-005; the sufficiency of financial resources; expected future cash balance and liquidity; licensing initiatives and collaborations; the Company’s plans and opportunities, including without lim itation offering a unique portfolio of innovative therapeutics; and the Company’s belief that its products and product candidates will result in improved outcomes f or pets. These forward- looking statements are based on management’s current expectations. These statements are neither promises nor guara ntees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; our lack of commercial sales; our failure to obtain any necessary additional financing; market conditions and our ability to raise capital under the shelf registration statement from the sale of our securities; our substantial dependence on the success of certain of our lead product candidates; our dependence on novel technologies and compliance with complex regulatory requirements; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; our inability to realize all of the anticipated benefits of our acquisitions of Vet Therapeutics and Okapi Sciences; uncertainties regarding the outcomes of studies regarding our products; the uncertainty of outcomes of the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our inability to identify, license, develop and commercialize additional product candidates; our failure to attract and keep senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers, partners and other third parties which conduct our target animal studies and certain other development efforts; unanticipated difficulties or challenges in the relatively new field of biologics development and manufacturing; our ability to market our products only for the treatment of indications for which they are approved; our small commercial organization; difficulties managing the growth of our organization; our significant costs of operating as a public company; risks related to the restatement of our financial statements for the year ended December 31, 2013 and the identification of a material weakness in our internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; limitations on our ability to use our net operating carryforwards; impact of generic products; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process; our failure to comply with regulatory requirements or obtain foreign regulatory approvals; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an “emerging growth company,” as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the significant control over our business by our principal stockholders and management; the potential that a significant portion of our total outstanding shares could be sold into the market in the near future; effects of anti- takeover provisions in our charter documents and under Delaware law; and our intention not to pay dividends. These and other important factors discussed under the caption "Risk Factors" in the Company’s Annual Report on Form 10 -K filed with the Securities and Exchange Commission, or SEC, on March 16, 2015, along with our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this presentation. Any such forward-looking statements represent management's estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation. 2

  3. Investment Highlights   Large, growing market Portfolio approach   De-risked drug development Scalable and capital-efficient   Private-pay First mover, pure-play 3

  4. Our Market U.S. Pet Owners Spend ($Billions)  Large and growing – 2014 U.S. pet spend of $58B  Insensitive to recent recessions  68% of U.S. households – 96M cats – 83M dogs  Medicalization drives growth – Historically, limited innovation – Pet therapeutics underrepresented Source: APPA. 4

  5. A Favorable Comparison Humans Pets Development Multiple Species Steps Direct to Species ~$1.3B ~$10M ~10 Years ~5 Years Third Party Payer Private Pay Commercial Generic Pressure Innovator Brand Loyalty Difficult & Indirect Accessible & Direct 5

  6. Regulatory Environment Year 1 Year 2 Year 3 Year 4 Year 5 FDA Center for Veterinary Medicine Proof of Concept INAD Chemistry, Mfg. & Controls (CMC) Safety Pilot ---> Pivotal Effectiveness Labeling, FOI Summary, Other Administrative NADA Year 1 Year 2 Year 3 Year 4 Year 5 USDA - Center for Veterinary Biologics Proof of Concept Manufacturing File for Product License Preclinical Field Safety and Efficacy Conditional Product License* Extended Field Safety and Efficacy Study Full Product License * Conditional licenses granted under special circumstances 6

  7. Initial Product Portfolio 2012 2013 2014 2015 2016 2017 2018 AT-001 Osteoarthritis/Pain Proof of Concept Safety & Effectiveness Chemistry, Mfg. & Control (CMC) US US EU EU Approval AT-002 Inappetence Proof of Concept Safety & Effectiveness Chemistry, Mfg. & Control (CMC) US US EU EU Approval AT-003 Post-Operative Pain Proof of Concept Safety & Effectiveness Chemistry, Mfg. & Control (CMC) US US EU EU Approval 7

  8. Our Pipeline Field Studies* Proof of Commercial Pilot Pivotal Concept in 2016 AT-004 AT-001 AT-002 AT-010 AT-009 Monoclonal Antibody DJD Pain Weight Gain B-cell Lymphoma Atopic Dermatitis Mast Cell Tumor AT-005 AT-012 AT-011 AT-007 AT-003 Monoclonal Antibody Feline Calicivirus Canine Parvovirus T-cell Lymphoma Immunodeficiency Virus Post-operative Pain AT-001 AT-017 AT-018 AT-016 AT-015 Osteoarthritis Lymphoma Atopic Dermatitis Allogeneic Stem Cell OA Lymphoma AT-002 AT-002 AT-Iota AT-006 Appetite Stimulant Weight Gain Periodontal Feline Herpesvirus AT-003 AT-008 Post-operative Pain Lymphoma AT-014 Osteosarcoma * Current or next intended field study 8

  9. Our Industry Historically, not innovation-focused Total number of NADAs NADAs for dogs / cats Pet therapeutic NCEs* 2011 12 6 2 2012 11 6 0 2013 6 4 2 2014 11 4 0 * NCE defined as new chemical entity not previously approved in humans or animals (excluding parasite drugs) 9

  10. Commercial Environment Practice Revenue Mix Annual Other Pharma Exams 9%  Innovation is valued 17% Vaccinations  Medicines are high 15% margin to practice Diagnostics Flea-Tick 17%  Facing pressure from Product Sales 6% alternative channels Heartworm Product Sales 6% Surgery Pet Food 17% Non-Invasive Sales Procedures 4% 9% Source: DVM Newsmagazine’s State of the Profession Report 2012. 10

  11. Planned Sales Effort Specialty and Primary Care  Direct sales force covering approximately two dozen territories  Supplemented by distributors  Corporate sales and eCommerce  Alignment with veterinarians ‒ Desire innovation ‒ Prescribe and dispense medications ‒ Partner mentality  Scalable commercial model Unique ability when compared to human therapeutics to focus on ROI given differences in payer and pharmacy environments 11

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