In connection with
the Jefferies’ Animal Health Leadership Summit
on
September 21, 2016 in London
, Aratana Therapeutics, Inc. (the “Company”)
provided certain business updates
.
|
·
|
|
The Company
has recently hired approximately two dozen Therapeutic Specialists in territories across the United States and it intends to host i
t
s first National Sales Meeting the week of September 26, 2016 in Kansas City. The newly-hired sales representatives were
selected
from a pool of more than 3,000 candidates and are industry veterans, with an average of more than a decade of animal health experience. Regional Sales Leaders and Medical Scientific Liaisons, as well as experienced sales and marketing leadership, round out the
commercial
organization.
|
|
·
|
|
On
October 6-9,
2016,
t
he Company
will attend the American College of Veterinary Surgeons (ACVS) Surgery Summit in Seattle, by which time
the Company
believes its commercial organization will be fully operational.
The Company
’s commercial focus during the fourth quarter of 2016
is expected to
be NOCITA® (bupivacaine liposome injectable suspension)
,
a local post-operative analgesia for cranial cruciate ligament surgery in dogs.
|
|
·
|
|
The
C
ompany
plans to
host an
internal
Aratana
Counsel of
Experts meeting
on
September 22-23
, 2016
and
among other things,
provide updates on its
pipeline. With respect to its
investigational U.S.
Department of Agriculture (“
USDA
”)
-regulated therapeutic for canine osteosarcoma (AT-014
)
, the Company plans to report that e
nrollment
continues
in a safety study of AT-014 and
the Company
anticipates USDA conditional licensure in the first half of 2017. With respect to
its
U.S. Food and Drug Administration
-regulated allogeneic stem cell therapeutic for canine osteoarthritis pain (AT-016)
,
the Company
report
s that
results of a previously disclosed pilot field efficacy trial have been published in the September 16 edition of
Frontiers in Veterinary Science
(“A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs”).
|
Important Safety Information
NOCITA® (bupivacaine liposome injectable suspension) is for use in dogs only. Do not use in dogs younger than 5 months of age, dogs used for breeding, or in pregnant or lactating dogs. Do not administer by intravenous or intra-arterial injection. Adverse reactions in dogs may include discharge from incision, incisional inflammation and vomiting. Avoid concurrent use with bupivacaine HCI, lidocaine or other amide local anesthetics. Please see the full
Prescribing Information
for more details.
Forward-Looking Statements
Certain statements contained in this report, including without limitation statements regarding the Company’s expectations for its commercial organization, product licensure and launches, product pipeline, and upcoming events and presentations are forward-looking statements within the meaning of the federal securities laws. In this report, the words “anticipates,” “believes,” “expects,” “intends,” “future,” “could,” “estimates,” “plans,” “would,” “should,” “potential,” “continues” and similar words or expressions identify forward-looking statements. Such forward-looking statements involve 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 AT-004, AT-005, AT-007 and AT-011; unstable market and economic conditions; restrictions on our financial flexibility due to the terms of our credit facility; our substantial dependence upon the success of our product candidates; development of our biologic product 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 product candidates; failure of our product candidates that receive regulatory approval to obtain market approval or achieve commercial success; 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 product candidates, and failure to compete effectively; failure to identify, license or acquire, develop and commercialize additional product 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 product candidates; our small commercial sales organization, and any failure to create a sales force or collaborate with third-parties to commercialize our product candidates; difficulties in managing the growth of our company; significant costs of being 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 veterinarian customers; limitations on our ability to use our net operating loss carryforwards; impacts of generic products; safety or efficacy concerns with respect to our product candidates; effects of system failures or security breaches; failure to obtain ownership of issued patents covering our product 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 product 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 15, 2016, 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 report.
Any such forward-looking statements represent management's estimates as of the date of this
report
. 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
report
.