Attached files
| file | filename |
|---|---|
| 8-K - 8-K - ARATANA THERAPEUTICS, INC. | d653201d8k.htm |
| EX-10.1 - EX-10.1 - ARATANA THERAPEUTICS, INC. | d653201dex101.htm |
| EX-99.1 - EX-99.1 - ARATANA THERAPEUTICS, INC. | d653201dex991.htm |
| EX-10.2 - EX-10.2 - ARATANA THERAPEUTICS, INC. | d653201dex102.htm |
 January 6,
2014 Exhibit 99.2 |
 2
Special
Note
Regarding
Forward-Looking
Statements
Safe Harbor Statement
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 statements regarding our
expectations regarding the approval of products; the prospects for Okapi Sciences; expected
product launch dates; the sufficiency of financial resources; expected future cash
balance and liquidity; expectations regarding development programs, trials, studies, and approval; expectations regarding in-license
initiatives, divestitures and partnerships; and expectations regarding the Company’s
plans and opportunities.
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
limited operating history and expectations of losses for the foreseeable future; our lack of commercial sales; our failure to obtain any necessary
additional financing; our substantial dependence on the success of certain of our current
compounds, AT-001, AT-002 and AT-003, the product candidates acquired in
our Vet Therapeutics transaction and the antiviral compounds acquired in the Okapi Sciences transaction, which are still in development; our
inability to identify, license, develop and commercialize additional product candidates; 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; uncertainties regarding the outcomes of studies regarding
our products; effects of competition; our failure to attract and keep senior management and
key scientific personnel; our complete reliance on third-party manufacturers and
third parties to conduct all our target animal studies and certain other development efforts; our lack of a sales organization; our
significant costs of operating as a public company; our lack of effective internal control
over financial reporting; changes in distribution channels for pet therapeutics;
consolidation of our customers; impacts 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; our failure to comply with
regulatory requirements; 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
most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission, or SEC, and 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.
|
 3
Investment Highlights
Large, growing market
De-risked drug development
Private-pay
Portfolio approach
Scalable and capital-efficient
Pure-play, first mover |
 4
Acquisition of Okapi Sciences NV
Strategic Rationale
Provides
a
European
base
of
operations
and
footprint
Enhances product portfolio
with six additional product candidates
bringing the PETX pipeline to > 20 products
Additional
de
novo
product
generation
capability
Antivirals
are
an
underserved
market
in
pet
therapeutics
Diversifies pipeline
further reducing risk
Continued
emphasis
on
innovation
–
Better coordination of clinical and regulatory activities
–
Enhanced business development and in-licensing capability
–
Flexibility with respect to European commercialization |
 5
Okapi Sciences NV
Leuven, Belgium |
 6
Okapi Key Personnel
Dr. Erwin Blomsma
—
PhD ‘95 / Postdoc at KU Leuven
—
Janssen Pharmaceutical
—
Avantium / Crystallics
Professor Dr. Johan Neyts
—
PhD ’93 / PostDoc University of North Carolina
—
Source of know-how and IP
Dr. Stefaan Wera
PhD ‘92 / Postdoc at Academic Institute, Basel
Belgian biotech startup experience
Dr. Nesya Goris
—
PhD ‘08 / Veterinary Sciences at Ghent University
—
Vet & Agrochemical Research Centre
—
Head of R&D at Okapi Sciences |
 7
Okapi Key Relationships
-
Discovery research
-
Development research
-
Project management
-
Regulatory
-
Business development
-
Operational support
-
Management
-
IP, rights
-
Know-how
-
PoC work
-
Medchem
Academia / Industry
-
Joint R&D
-
Distribution
-
M&S
-
PhV
-
R&D support
L D R Partners
-
Investors
-
Governments
-
Regulatory support
-
Analytical / QP
-
Scientific advice
-
MAA / ASMF / etc
CMO
-
Chemical development
-
Process development
-
VICH stability work
-
cGMP production
-
Development support
-
Analytical / GLP / GCP
-
cGMP analytical
-
Regulatory studies
CRO
-
Scientific advisors
-
Legal, IP, BD, etc |
 8
80% of pets get viral infections
Only symptoms can be treated,
not the infection
Under-recognized, under-
diagnosed
Lack of Antivirals for Pets
Feline
Herpesvirus
Calicivirus
Parvo Virus
FIV |
 9
Okapi Pipeline
*Referring to expected first launch in US or Europe
Feline immunodeficiency
Feline herpes
Canine drug –
Lymphoma
Canine drug –
Parvovirus
Feline drug –
Calicivirus
De Novo
Pre-Clinical
Clinical
Approval Launch*
2015
2017
2017+
2018+
2018+
2019+ |
 10
Feline Herpes is a common virus
in cats
–
95% of cats exposed
–
3% with symptoms in US and EU
–
Ocular symptoms most common
Vaccinations are only option
–
Kittens vaccinated at 6 weeks
Similar to humans, virus not cured
AT-006
Feline Herpes
Calici
Herpes
FIV
FELV
FIP
Parvo
I
n
c
i
d
e
n
c
e |
 11
FIV is a serious viral disease in cats
–
2% incidence in the US
–
>10% incidence in parts of Europe and Asia
Vaccinations are only option (US only)
–
Kittens vaccinated at 6 weeks
–
Not fully protective
Cats can have shorter lives after
infection and illness
AT-007
Feline immunodeficiency virus
Calici
Herpes
FIV
FELV
FIP
Parvo
I
n
c
i
d
e
n
c
e |
 12
Other Assets
Production animal products
–
Molecules may work in livestock and could become crucial in
containing viral outbreaks
–
Swine Flu, Foot & Mouth Disease, etc.
–
Funded largely with subsidies and grants
–
To be divested or spun-out after value inflection
–
Production animal companies have interest
Koi herpes diagnostic
–
To be divested or spun-out after value inflection |
 13
Portfolio Construction
Toxicology data are available
Effectiveness data are available
Manufacturing is scaled-up
Key Attributes
Unmet medical need
High incidence or prevalence
Known mechanism of action
Nuance in science
“Early
de-risking”
Early De-Risking
Leveraging the investment in human therapeutics
Pharmaceuticals
Biologics |
 14
De-Risked Product Development
Proof of Concept in Lab Animals
Animal Toxicology
SAR Chemistry, Selection of Lead
Animal pK
In vitro
Chemistry Optimization
IND Filing
Human Clinical Studies
Phase I
Phase II
Final Formulation
Phase III
NDA
Proof of Concept in Dogs/Cats
pK in Dogs/Cats
API and Formulation Development
Dose Selection
Probe Safety in Dogs/Cats
Final Formulation
Field Studies
NADA
EU
Approval
De-Risking
Cat molecule
YR1
YR2
YR3
YR4
YR5
YR6
YR7
YR8
YR9
YR10
YR11
YR12
YR13
Toxicology |
 15
Aratana’s Pipeline
AT-011 Dog
Canine Parvovirus
AT-012 Cat
Feline Calicivirus
Lymphoma Diagnostic
AT-013 Cat
Lymphoma
AT-010 Dog
Atopic Dermatitis
Diagnostic Koi Carp
KHV Infections
AT-009 Mast Cell –
Dog
AT-007 Cat
Feline Immunodeficiency virus
AT-006 Cat
Feline Herpesvirus
Option 1
Alpha
AT-008 Dog
Lymphoma
AT-002 Dog
Appetite Stimulant
Option 2
Beta
AT-003 Dog
Post-operative Pain
AT-004 Dog
B-Cell Lymphoma
Option 3
Gamma
AT-003 Cat
Post-operative pain
AT-005 Dog
T-Cell Lymphoma
AT-001 Cat
Osteoarthritis
AT-002 Cat
Appetite Stimulant
AT-001 Dog
Osteoarthritis
Proof of Concept
Pilot
Pivotal / Commercial |
 16
Deal Structure
Approximately €33.3M total consideration
Stock Purchase
€10.3M cash paid at closing
€11M promissory note
Due December 31, 2014, subject to mandatory prepayment upon an
equity financing
7% interest
€12M post-closing consideration
Due April 7, 2014, subject to mandatory prepayment in cash upon an
equity financing
If not paid in cash by April 7, 2014, payable in stock based on 10-day
average closing price before April 4
Collar = 1,060,740 share maximum, 707,160 share minimum |
 17
Our Financial Profile
Partnering opportunities globally
Out-licensing of non-core products
Advancing product portfolio
Begin to build commercial capabilities
Fund operations through 2014
Top Institutional Investors
Wellington Management
Adage Capital Partners
Special Situations Funds
JPMorgan Chase & Co
Jennison Associates
Fidelity Investments
Principal Financial Group
D.E. Shaw & Co.
Hutchin Hill Capital
Kopp Investment Advisors
Current financial resources are expected
to enable:
Continue to identify non-dilutive sources
of capital |
 18
Landscape
Big Animal Health
Biotech
Canfel Therapeutics |
 19
Investment Highlights
Large, growing market
De-risked drug development
Private-pay
Portfolio approach
Scalable and capital-efficient
Pure-play, first mover |