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1Provided March 27, 2019; Aratana disclaims any duty to update
Accelerating Health through 1Data
Benefits of 1DataAn Animal Health Industry Perspective
K-State Olathe27 March 2019
Ernst Heinen, DVM, PhD
2Provided March 27, 2019; Aratana disclaims any duty to update
Special Note Regarding Forward-Looking StatementsThis presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Al l s tatements 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 our ability to bring innovative products to the market; study, development and commercialization of our approved therapeutics or therapeutic candi dates; and statements regarding the Company's efforts, plans and opportunities, including, without l imitation, advancing our therapeutic candidates and offering innovative therapeutics that help manage pet’s medical needs safely and effectively and that result in longer and improved quality of life for pets.
These forward-looking statements are based on the Company's current expectations. These s tatements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking s tatements, including, but not limited to, the following: our history of operating losses and our expectation that we will continue to incur losses for the foreseeable future; failure to obtain sufficient capital to fund ou r operations; ri sks relating to the impairment of intangible assets; ri sks pertaining to stockholder class action lawsuits; unstable market and economic conditions; restrictio ns on our financial flexibility due to the terms of our credit facility; our substantial dependence upon the commercial success of our therapeutics; development of our biologic therapeutic candidates is dependent upon relatively novel technologies and uncertain regulatory pathways, and biologics may not be commercially viable; denial or delay of regulatory approval for our existing or future therapeutic candidates; failure of our therapeutic candidates that receive regulatory approval to achieve market acceptance o r achieve commercial success; product liability lawsuits that could cause us to incur substantial liabilities and l imit commercialization of current and future therapeutics; failure to realize anticipated benefits of our acquisitions and difficulties associated with integrating the acquired businesses; development of pet therapeutics is a lengthy and expensive process with an uncertain outcome; competition in the pet therapeutics market, including from generic a lternatives to our therapeutic candidates, and failure to compete effectively; fa ilure to identify, l icense or acquire, develop and commercialize additional therapeutic candidates; failure to attract and retain senior management and key scientific personnel; our reliance on third-party
manufacturers, suppliers and partners; regulatory restrictions on the marketing of our approved therapeutics and therapeutic candidates; our small commercial sales organization, and any fa ilure to create a sales force or collaborate with third -parties to commercialize our approved therapeutics and therapeutic candidates; difficulties in managing the growth of our company; significant costs of being a public company; ri sks related to the effectiveness of our internal controls; changes in distribution channels for pet therapeutics; consolidation of our veterinarian customers; limitations on our ability to use our net operating loss carryforwards; the impact of tax reform legislation; impacts of generic products; safety or efficacy concerns with respect to our therapeutic candidates; effects of system failures or security breaches; delay or termination of the
development of grapiprant therapeutic candidates and commercialization of grapiprant products that may arise from termination of or failure to perform under the col laboration agreement and/or the co-promotion agreement with Elanco; failure to obtain ownership of i ssued patents covering our therapeutic candidates or failure to prosecute or enforce licensed patents; failure to comply with our obligations under our license agreements; effects of patent or other intellectual property lawsuits; failure to protect our intellectual property; changing patent laws and regulations; non-compliance with any legal or regulatory requirements; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process and the costs associated with government regulat ion of our therapeutic candidates; failure to obtain
regulatory approvals in foreign jurisdictions; effects of legislative or regulatory reform with respect to pet therapeutics; the volatility of the price of our common stock; our status as an emerging growth company, which could make our common stock less attractive to investors; dilution of our common stock as a result of future financings; the influence of certain significant stockholders over our business; and provisions in our charter documents and under Delaware l aw could delay or prevent a change in control. 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 14, 2018, a long with our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking s tatements
made in this presentation. Any such forward-looking s tatements represent the Company’s estimates as of the date of this presentation. While we may elect to update such forward-looking s tatements at some point in the future, we disclaim any obligation to do so, even i f subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation.
Safe Harbor Statement
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3Provided March 27, 2019; Aratana disclaims any duty to update
NADA StatisticsOriginal and Conditional NADAs
Calendar Year Total Livestock Horses Cat & Dogs New Chemical Entitles/New
Molecular Entities
2008 12 10 0 3 1
2009 10 6 0 4 2*
2010 9 1 4 4 1
2011 11 3 1 7 3
2012 11 5 0 6 3
2013 5 2 1 2 2
2014 10 3 3 4 1
2015 11 4 1 5 3**
2016 15+ 4 1 9 5
2017 9+ 8 0 1 0
2018 16+ 9 0 7 3
3
+ Number includes changes of use condition from OTC to VFD* GE Animal
Source: FDA CVM
4Provided March 27, 2019; Aratana disclaims any duty to update
Where can I find data on animal patients?
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5Provided March 27, 2019; Aratana disclaims any duty to update
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Visual credit: Zoetis
6Provided March 27, 2019; Aratana disclaims any duty to update
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18E
($Billions)
Our MarketPet Owner Spend - US
68%Households with Pets
90M94M
Source: APPA March 20186
7Provided March 27, 2019; Aratana disclaims any duty to update
The animal health industry has a significant and pervasive problem:
High quality data are not readily available
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8Provided March 27, 2019; Aratana disclaims any duty to update
Lack of data
▪ Demographics
▪ Health records
▪ Disease incidences
▪ Patient or disease registries
▪ Health surveys
▪ Prescription data
▪ Treatment costs
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9Provided March 27, 2019; Aratana disclaims any duty to update
Who has data?
▪ Diagnostic companies▪ Pet wearables▪ Pet insurances▪ Veterinary practice management services▪ Corporate veterinary hospitals▪ Lifetime studies▪ Pet pharmaceutical developers
But how do we integrate data from different sources?
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10Provided March 27, 2019; Aratana disclaims any duty to update
Lifetime prospective studies
▪ Golden Retriever Lifetime Study (USA) by Morris Animal Foundation3044 Golden Retriever (2012-2015)
▪ 9/11 Medical Surveillance Study of search dogs (USA)95 dogs from 9/11, 55 control dogs
▪ Generation Pub (UK) University of Bristol; Dogs TrustAll breeds, pubs 16 weeks of age or less over 2,200 dogs
▪ Dogslife (UK) Universities of Edinburgh, Manchester, and Liverpool, The Kennel ClubOver 7800 Labrador Retrievers *1 Jan 2010 and later
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11Provided March 27, 2019; Aratana disclaims any duty to update
Pivotal Clinical Field StudiesSome examples
▪ Revolution PLUS – Zoetis– Approved 9 Nov 2018– Flea, tick, mites, heart-, round-, and hookworms in cats
▪ Semintra – Boehringer Ingelheim– Approved 15 May 2018– Control of systemic hypertension in cats
▪ Pexion – Boehringer Ingelheim– Approved 4 Dec 2018– Treatment of noise aversion in dogs
▪ Entyce – Aratana– Approved 16 May 2016– Appetite stimulation in dogs
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12Provided March 27, 2019; Aratana disclaims any duty to update
revolution PLUS (selamectin and sarolaner topical solution)
▪ 17 Laboratory studies (186 laboratory cats)
▪ 3 Field studies (476 client owned cats)
▪ Field Flea Effectiveness and Safety Study
– n=429 (product 281, pos control 148)
– Three treatments 30 days apart, 90 days in-life
– Primary: flea count; secondary: FAD clinical signs, AEs
– Observations▪ Physical exam and body weight: 4x
▪ Hematology, blood chemistry, urinalysis: 2x
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13Provided March 27, 2019; Aratana disclaims any duty to update
Semintra(telmisartan oral solution)
▪ (1) 28-day field effectiveness and safety study, (2) followed by a 5-month field safety study
▪ (1) n=288 (product 192, placebo 96)(2) n=107 (product)
▪ Primary: SBP change from baseline; secondary: clinical relevant SBP reduction, distribution of change in SBP; AEs
▪ Observations– Physical exam, SBP: 7x– Retinal photography: 5x– Hematology, blood chemistry, urinalysis: 4x
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14Provided March 27, 2019; Aratana disclaims any duty to update
Pexion(imepitoin tablets)
▪ New Year’s Eve fireworks field study in Germany and The Netherlands
▪ n=238 (product 114, placebo 124)▪ Three days of treatment BID▪ Noise aversion assessment using the Lincoln
Sound Sensitivity Scale– Overall effect compared to previous noise events (fire
works)– Sum of behavior scores measure at 4 fixed time points
▪ AEs
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15Provided March 27, 2019; Aratana disclaims any duty to update
Entyce(capromorelin oral solution)
▪ Three day field effectiveness and safety study▪ Safety population n=244
Effectiveness population n=177 (product 121, placebo 56)
▪ Three days of treatment SID▪ Primary: owner appetite assessment
Secondary: owner appetite assessment questionnaire; body weight gain, AEs
▪ Observations– Appetite assessment: 2x– Physical exam, body weight: 2x– Hematology, blood chemistry, urinalysis: 2x
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16Provided March 27, 2019; Aratana disclaims any duty to update
What to do with data?
▪ Making better business decisions– Development decisions
– Project prioritization
– Targeted product launches
▪ Advance innovation faster, more predictably– Selection of suitable patients
– Selection of endpoints
– Biomarkers
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17Provided March 27, 2019; Aratana disclaims any duty to update
Canine Osteoarthritis Studies
▪ Rimadyl (carprofen) Hoffman-LaRoche, Pfizer, Zoetis
▪ EtoGesic (etodolac)Wyeth, Fort Dodge, Boehringer Ingelheim
▪ Deramaxx (deracoxib)G.D Searle, Novartis, Elanco
▪ Previcox (firocoxib)Merck, Merial, Boehringer Ingelheim
▪ Galliprant (grapiprant)Pfizer, RaQualia, Aratana/Elanco
Total of about 2,100 patients
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18Provided March 27, 2019; Aratana disclaims any duty to update
Thank You!
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