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Provided September 13, 2018. Provided August 3, 2018.
A pione e r in pe t the ra pe utic s. De live ring sa fe a nd e ffe c tive the ra pe utic s tha t e le va te the sta nda rd o f c a re in ve te rina ry me dic ine
1 Provided September 13, 2018. Provided August 3, 2018. Safe Har - - PowerPoint PPT Presentation
A pione e r in pe t the ra pe utic s. De live ring sa fe a nd e ffe c tive the ra pe utic s tha t e le va te the sta nda rd o f c a re in ve te rina ry me dic ine 1 Provided September 13, 2018. Provided August 3, 2018. Safe Har bor
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Provided September 13, 2018. Provided August 3, 2018.
A pione e r in pe t the ra pe utic s. De live ring sa fe a nd e ffe c tive the ra pe utic s tha t e le va te the sta nda rd o f c a re in ve te rina ry me dic ine
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Provided September 13, 2018.
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 anticipated financial performance; our anticipated use of cash in 2018; our ability to bring innovative therapeutics to the market; steps necessary for and timing of regulatory submissions and approvals of therapeutic candidates; study, development and commercialization of therapeutics or therapeutic candidates, including without limitation ongoing efforts to commercialize ENTYCE and NOCITA; timing of anticipated study results; increased market recognition of and demand for our therapeutics; our beliefs on sales coverage of our pet therapeutics in our MSAs in the U.S.; and statements regarding the Company's efforts, plans and opportunities, including, without limitation, 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 management's current expectations. These statements are neither promises nor guarantees, 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 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 our operations; risks relating to the impairment of intangible assets; risks pertaining to stockholder class action lawsuits; unstable market and economic conditions; restrictions 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 or achieve commercial success; product liability lawsuits that could cause us to incur substantial liabilities and limit 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 alternatives to our therapeutic candidates, and failure to compete effectively; failure to identify, license 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 failure 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; risks 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
collaboration agreement and/or the co-promotion agreement with Elanco; failure to obtain ownership of issued 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 regulation 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 law 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, 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, 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.
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$0 $10 $20 $30 $40 $50 $60 $70 $80
1994 1996 1998 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018E ($Billions)
Pet Owner Spend - US
Households with Pets
90M 94M
Source: APPA March 2018
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Provided September 13, 2018.
“Snoopy Generation” “Brian Generation”
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Historical Situation
Emerging Trends
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Provided September 13, 2018.
Source: United States Government Federal Register based on FDA fiscal year. * Pet New Chemical Entities defined by Aratana as new chemical entities not previously fully approved in humans or pets (excluding parasite drugs) 39 27 41 45 22 39
6 4 4 5 10 2 2 2 2012 2013 2014 2015 2016 2017
NMEs for Humans NADAs for cats/dogs Pet NCEs*
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Build Brand Awareness
Encourage Trial, Penetration and Retention
Enable and Measure
Educate and Train
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Dispensed in Clinic/Pharmacy/Home Delivery
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Provided September 13, 2018.
10 Lower Higher Higher Lower
Relevance to Specialists Primary Care Adoption
Direct +/- Contract Selling Co-promotion & Distribution Direct & Distribution
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Provided September 13, 2018.
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Our sales team covers MSAs of approximately 80% of multi-specialty & 40% of general practices Our recent experience indicates > 50% of pet therapeutic revenue is from
Data on file as of December 2017.
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Provided September 13, 2018.
been ordered by 10,000 U.S. veterinary clinics and more than half of ENTYCE customers re-ordered in the second quarter of 2018
therapeutic specialists, net sales were 250% higher than non-targeted accounts in the second quarter. We have observed a positive correlation between net sales an the number of educational events and promotion by our therapeutic specialists
showed that of the veterinarians prescribing ENTYCE, 90% are doing so because of the therapeutic’s efficacy
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Opportunity ENTYCE Clinics 40%
$1.3M $0.8M $1.3M
Q4 2017* Q1 2018 Q2 2018
ENTYCE Net Product Sales
~25,000 U.S. Veterinary Clinics
ENTYCE Clinics
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*Approximately half as initial stocking orders
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Provided September 13, 2018.
interactions to educate & discuss the long- acting local anesthetic’s impact on the veterinary surgical protocol
surgeons, 90% of those surveyed were aware of NOCITA and they’re prescribing NOCITA because it provides 72 hours of pain relief and its safety profile
expansion to include its use as a peripheral nerve block to provide regional post-
in cats
supplier of NOCITA, Pacira, and anticipate commencing a post-approval submission process for a smaller vial size. If approved, we anticipate a 10 mL vial could be available in the fall of 2019
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Provided September 13, 2018.
Re-ordered 65% Initial Only 35%
$150K $330K $650K $730K $1.1M $1.5M $1.8M
Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018
NOCITA Net Product Sales 30%
Corporate Account Orders
Customers in 2017
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Provided September 13, 2018.
GALLIPRANT is already the second-leading NSAID tablet stocked by veterinarians and has achieved approximately 13% market share1
thirds stocking GALLIPRANT in 20182
safety profile as the top reason for stocking3
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1. Elanco third-party market research on file. A sample of veterinary clinics as of June 2018. 2. Data on file as of June 2018. 3. Third-party research on file as of September 2017.
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Provided September 13, 2018.
Source: VetStreet, Elanco Market Share Report, published January 2018
*GALLIPRANT is marketed in collaboration with Elanco Animal Health
$5M $4M $6M $8M $9M $10M Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018
GALLIPRANT* Sales
U.S. SOM and Market Size
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Chart is not comprehensive.
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Provided September 13, 2018.
that is thought to work by inhibiting the EP4 receptor downstream on the arachidonic cascade
indications in dogs and cats
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~$9.8 million to cover existing debt principal obligations
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“I have nothing that works well for
makes it difficult to diagnose or treat the underlying condition.” “Lack of appetite can be very distressful to owners. If the dog isn’t eating they call me and if I can’t fix the problem, it can be
for euthanasia.” 10 million dogs are inappetent 4 million dogs are treated for inappetence
(2M chronic/2M acute)
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muscle wasting
1Ettinger SJ, Feldman EC. Textbook of Veterinary Internal Medicine. Vol 1. 7th ed. St. Louis, MO: Saunders Elsevier; 2010. 2Liu DT, Brown DC, Silverstein DC. Early nutritional support is associated with decreased length of hospitalization in dogs with septic peritonitis: a
retrospective study of 45 cases (2000-2009). J Vet Emerg Crit Care (San Antonio). 2012;22(4):453-459.
3Seller CA, Ravalia A. Anaesthetic implications of anorexia nervosa. Anaesthesia. 2003;58(5):437-443.
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Unde r lying c onditions that c an le ad to inappe te nc e
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29 29 20 5 Chronic Conditions Acute Conditions Aging Pet Conditions End-of-Life Conditions
(n=409) (n=373) (n=393) (n=393) Aratana Research Sept. 2015. Q120. On average, how many days of treatment are needed by dogs suffering from inappetence due to each of the following condition types over the course of one year? (Base: Treat dogs with condition type)
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approved drugs to stimulate appetite; clinicians were using drugs extra-label to treat inappetence
unsatisfied with products available to treat in inappetence1
for an effective product indicated to treat inappetence1 Be for e E NT YCE , tr e atme nt options we r e limite d
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(n=166)
agonist that mimics the effect of ghrelin (the “hunger hormone”)
ghrelin, ENTYCE binds to specific cell receptors and affects signaling in the hypothalamus, causing the feeling of hunger. Me c hanism of Ac tion
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appetite stimulation in dogs
mimics ghrelin (the “hunger hormone”) to trigger feelings of hunger
appetite in dogs
veterinarian can diagnose and treat the underlying chronic or acute condition Summar y
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Post- Ope r ative Pain
1Lascelles BDX, Kirkby Shaw K. (2016), An extended release local anesthetic: potential for future use in veterinary surgical patients? Vet Med Sci, 2:229-238. doi:10.1002/vms3.43.
Graph: Tomas et al. 2015. Canine arthrotomy model. The Veterinary Journal 2015 Jun;204(3):293-8.
20 40 60
6 24 30 48 54 72
SI % BW distribution Time (hours)
performed
wound healing, which lasts approximately 72 hours
time analgesics should be provided following surgery1
preventing transduction and transmission of pain signals
and do not appear to delay tissue healing1
1Epstein ME, Rodanm I, Griffenhagen G, et al. 2015 AAHA/AAFP pain management guidelines for dogs and cats. J Feline Med Surg. 2015;17(3)251-272. 2Mathews K, Kronen PW, Lascelles D, et al. Guidelines for recognition, assessment and treatment of pain. J Small Ani. 2014;55(6):E10-E68
A long-acting local anesthetic that lasts up to 72 hours post-surgery
suspension that releases over time
surgical site to provide local post-
cruciate ligament surgery in dogs
to provide regional postoperative analgesia following onychectomy in cats
multivesicular liposomes containing bupivacaine
administration prior to surgery
mL/kg per forelimb, for a total dose
nerve block technique2
administration as a nerve block in cats
1NOCITA Prescribing Information, August 3, 2018. 2Enomoto M, Lascelles BDX, Gerard MP. Defining the local nerve blocks for feline distal thoracic limb surgery: a cadaveric study. JFMS 2016;18(10):838-845.
degree of tissue trauma and associated pain1
effective means of preventing/relieving pain, however, previous options have limitations
anesthetic that controls post-op pain with
following canine CCL surgery or feline
1Epstein ME, Rodanm I, Griffenhagen G, et al. 2015 AAHA/AAFP pain management guidelines for dogs and cats. J Feline Med Surg. 2015;17(3):251-272.