LEAWOOD, Kan., Nov. 3, 2016 /PRNewswire/ -- Aratana
Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company
focused on the licensing, development and commercialization of
innovative biopharmaceutical products for companion animals,
announced its third quarter 2016 financial and operational results.
For the quarter ended September 30,
2016, Aratana reported a net loss of $13.4 million or $0.38 diluted net loss per share.
"We have become a fully integrated development and commercial
company with the FDA granting approval for our third therapeutic in
2016 and subsequent commercial launch," stated Steven St. Peter, M.D., President and Chief
Executive Officer of Aratana Therapeutics. "We are very pleased to
begin making our innovative therapeutics available to veterinarians
across the United States."
Recent Highlights
- Aratana was granted U.S. Food and Drug Administration (FDA)
approval of NOCITA® (bupivacaine liposome injectable
suspension) on August 12, 2016 to
provide local post-operative analgesia for cranial cruciate
ligament surgery in dogs. Nocita was made commercially available to
veterinarians in the United States
in October 2016.
- The Company continues to anticipate commercial launch of
ENTYCE® (capromorelin oral solution) in the first
quarter of 2017, assuming Aratana's supply of Entyce is approved
and released.
- In November 2016, Elanco
communicated to the Company that they anticipate commercial launch
of GALLIPRANT® (grapiprant tablets) in early 2017,
assuming Aratana's supply of Galliprant is approved and
released.
- Aratana continued to enroll dogs in the pivotal field safety
study for AT-014, an investigational canine osteosarcoma vaccine,
during the third quarter of 2016. The Company continues to
anticipate conditional licensure from the U.S. Department of
Agriculture in the first half of 2017.
- During the third quarter of 2016, our collaboration partner
initiated a pivotal field effectiveness study under an
FDA-concurred protocol for AT-016, an investigational allogeneic
stem cell treatment for canine osteoarthritis pain.
- In October 2016, Aratana reviewed
results of a pilot study investigating AT-018 in client-owned dogs
with recurrent atopic dermatitis receiving corticosteroids. While
the study did not demonstrate sufficient activity to merit
continued development in such clinical setting, Aratana intends to
further investigate AT-018 to prevent clinical signs in at-risk
dogs.
- The Company hired approximately two dozen Therapeutic
Specialists in territories across the
United States in the third quarter of 2016. The Company's
commercial organization also includes Regional Sales Leaders,
National Account Managers and Medical Scientific Liaisons, along
with the sales and marketing leadership.
Financial Results
The Company's third quarter net
loss was $13.4 million or
$0.38 diluted net loss per share,
compared to a net loss of $54.4
million or $1.58 diluted net
loss per share for the corresponding quarter ended September 30, 2015. For the third quarter ended
September 30, 2015, the net loss
included a $43.4 million impairment
charge. Revenues in the third quarter of 2016 totaled $40 thousand, including revenues from product
sales of BLONTRESS® (Canine Lymphoma Monoclonal Antibody
B-cell) and TACTRESS™ (Canine Lymphoma Monoclonal Antibody T-cell),
compared to $229 thousand in net
revenues from product sales during the corresponding quarter in
2015. For the first nine months of 2016, total revenues were
$38.3 million versus $615 thousand for the same nine month period in
2015. In the second quarter of 2016, the Company reported
$38.0 million in net revenue from the
$45.0 million payment received from
the collaboration agreement with Elanco Animal Health, Inc., a
division of Eli Lilly and Company. The remaining $7.0 million is held on the balance sheet as a
licensing and collaboration commitment.
Research and development expenses for the third quarter ended
September 30, 2016 totaled
$5.3 million compared to $6.2 million for the quarter ended September 30, 2015. For the first nine months of
2016, research and development costs totaled $21.4 million as compared to $18.5 million for the corresponding nine month
period in 2015. The increase in the nine month period was primarily
due to the $5.9 million in regulatory
milestones achieved for Galliprant, Entyce, Nocita and AT-016,
which was partially offset by a decrease in costs related to the
completion of several clinical studies for our lead programs.
Selling, general and administrative expenses totaled
$6.9 million for the third quarter
ended September 30, 2016 compared to
$5.0 million for the corresponding
period in 2015. Selling, general and administrative expenses for
the first nine months of 2016 and 2015 totaled $19.6 million and $14.1
million, respectively. The increase in the nine month period
was due to the continued investment in commercial activities to
prepare for the launches of our approved products. The increase in
the nine month period also reflected a credit of $1.2 million recorded in the first quarter of
2015 to reduce the fair value of a contingent consideration to
zero.
As of September 30, 2016, the
Company had $102.7 million of cash,
cash equivalents, restricted cash and short-term investments. This
represents an increase in cash of approximately $16.1 million from December 31, 2015, largely due to the upfront
payment received from Elanco of $45.0
million in the second quarter of 2016. During the quarter
ended September 30, 2016, the Company
agreed to sell 1,629,408 shares of Aratana common stock pursuant to
its sales agreement with Barclays Capital Inc. for approximately
$14.6 million, of which 1,416,052
shares settled during the third quarter of 2016. Net proceeds of
approximately $12.1 million were
received during the third quarter of 2016 and the remaining
approximately $2.5 million was
received subsequent to the third quarter of 2016. The Company has
not agreed to sell any additional shares since September 30, 2016.
Webcast & Conference Call Details
The Company will
host a live conference call on November 4,
2016 at 8:30 a.m. ET to
discuss financial results for the third quarter ended September 30, 2016.
Interested participants and investors may access the audio
webcast or use the conference call dial-in:
1 (866) 364-3820 (U.S.)
1 (855) 669-9657 (Canada)
1 (412) 902-4210 (International)
A replay of the third quarter results teleconference will be
available the same day of the event by approximately 11 a.m. ET and an audio webcast will be
accessible for 90 days in the Aratana Investor Room. For a replay
of the call, use the below dial-in and conference ID 10095395:
1 (877) 344-7529 (U.S.)
1 (855) 669-9658 (Canada)
1 (412) 317-0088 (International)
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 HCl, lidocaine or other amide local
anesthetics. Please see the full Prescribing
Information for more detail.
ENTYCE® (capromorelin oral solution) is for use in
dogs only. Do not use in breeding, pregnant or lactating dogs. Use
with caution in dogs with hepatic dysfunction or renal
insufficiency. Adverse reactions in dogs may include diarrhea,
vomiting, polydipsia, and hypersalivation. Should not be used in
dogs that have a hypersensitivity to capromorelin. Please see the
full Prescribing Information for more detail.
GALLIPRANT® (grapiprant tablets) is for use in dogs
only. Do not use in dogs younger than 9 months of age and less than
8 lbs (3.6 kg), dogs used for breeding, or in pregnant or lactating
dogs. Adverse reactions in dogs may include mild gastrointestinal
effects including, vomiting, diarrhea and decreased appetite.
Should not be used in dogs that have a hypersensitivity to
grapiprant. Avoid use with COX-inhibiting NSAIDs or
corticosteroids. Please see the full Prescribing Information for
more detail.
About Aratana Therapeutics
Aratana Therapeutics is a
pet therapeutics company focused on licensing, developing and
commercializing innovative biopharmaceutical products for companion
animals. Aratana believes that it can leverage the investment in
the human biopharmaceutical industry to bring therapeutics to pets
in a capital and time efficient manner. The Company's pipeline
includes therapeutic candidates targeting pain, inappetence,
cancer, viral diseases, allergy and other serious medical
conditions. Aratana believes the development and
commercialization of these therapeutics will permit veterinarians
and pet owners to manage pets' medical needs safely and
effectively, resulting in longer and improved quality of life for
pets. For more information, please visit www.aratana.com.
Forward-Looking Statements Disclaimer
This press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. All
statements contained in this press release 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 several innovative products to market;
expectations regarding the steps necessary for and timing of
regulatory submissions and approvals of product candidates;
expectations regarding the timing or scope of launch and
commercialization of approved products or product candidates;
expectations regarding product candidate studies, including with
respect to AT-018; and statements regarding the Company's plans and
opportunities, including, without limitation, 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 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 press release. Any such forward-looking statements
represent management's estimates as of the date of this press
release. 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 press release.
Contacts
For investor inquires:
Craig Tooman
ctooman@aratana.com
(913) 353-1026
For media inquiries:
Rachel Reiff
rreiff@aratana.com
(913) 353-1050
ARATANA
THERAPEUTICS, INC.
Consolidated
Statements of Operations (Unaudited)
(Amounts in
thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and
collaboration revenue
|
|
$
|
—
|
|
$
|
—
|
|
$
|
38,151
|
|
$
|
—
|
Product
sales
|
|
|
40
|
|
|
229
|
|
|
108
|
|
|
615
|
Total
revenues
|
|
|
40
|
|
|
229
|
|
|
38,259
|
|
|
615
|
Costs and
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
|
286
|
|
|
138
|
|
|
2,046
|
|
|
357
|
Royalty
expense
|
|
|
19
|
|
|
23
|
|
|
57
|
|
|
66
|
Research and
development
|
|
|
5,334
|
|
|
6,197
|
|
|
21,386
|
|
|
18,499
|
Selling, general and
administrative
|
|
|
6,924
|
|
|
4,997
|
|
|
19,623
|
|
|
14,061
|
Amortization of
intangible assets
|
|
|
91
|
|
|
483
|
|
|
281
|
|
|
1,449
|
Impairment of
intangible assets
|
|
|
—
|
|
|
43,398
|
|
|
2,780
|
|
|
43,398
|
Total costs and
expenses
|
|
|
12,654
|
|
|
55,236
|
|
|
46,173
|
|
|
77,830
|
Loss from
operations
|
|
|
(12,614)
|
|
|
(55,007)
|
|
|
(7,914)
|
|
|
(77,215)
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
116
|
|
|
33
|
|
|
276
|
|
|
147
|
Interest
expense
|
|
|
(859)
|
|
|
(226)
|
|
|
(2,554)
|
|
|
(661)
|
Other income,
net
|
|
|
(14)
|
|
|
—
|
|
|
(50)
|
|
|
5,141
|
Total other income
(expense)
|
|
|
(757)
|
|
|
(193)
|
|
|
(2,328)
|
|
|
4,627
|
Loss before income
taxes
|
|
|
(13,371)
|
|
|
(55,200)
|
|
|
(10,242)
|
|
|
(72,588)
|
Income tax
benefit
|
|
|
—
|
|
|
758
|
|
|
—
|
|
|
1,389
|
Net
loss
|
|
$
|
(13,371)
|
|
$
|
(54,442)
|
|
$
|
(10,242)
|
|
$
|
(71,199)
|
Net loss per share,
basic and diluted
|
|
$
|
(0.38)
|
|
$
|
(1.58)
|
|
$
|
(0.29)
|
|
$
|
(2.08)
|
Weighted average
shares outstanding, basic and diluted
|
|
|
35,092,686
|
|
|
34,405,646
|
|
|
34,837,169
|
|
|
34,293,357
|
ARATANA
THERAPEUTICS, INC.
Consolidated
Balance Sheets (Unaudited)
(Amounts in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2016
|
|
December 31,
2015
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash, cash equivalents
and short-term investments
|
|
$
|
102,341
|
|
$
|
86,202
|
Accounts receivable,
net and prepaid expenses and other current assets
|
|
|
3,029
|
|
|
1,511
|
Inventories
|
|
|
5,575
|
|
|
1,306
|
Total current
assets
|
|
|
110,945
|
|
|
89,019
|
Property and
equipment, net
|
|
|
2,122
|
|
|
2,555
|
Goodwill
|
|
|
40,275
|
|
|
39,781
|
Intangible assets,
net
|
|
|
13,333
|
|
|
15,067
|
Restricted
cash
|
|
|
350
|
|
|
350
|
Other long-term
assets
|
|
|
289
|
|
|
294
|
Total
assets
|
|
$
|
167,314
|
|
$
|
147,066
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts payable,
accrued expenses
|
|
$
|
8,567
|
|
$
|
5,647
|
Licensing and
collaboration commitment
|
|
|
7,000
|
|
|
—
|
Current portion –
loans payable
|
|
|
5,833
|
|
|
—
|
Other current
liabilities
|
|
|
8
|
|
|
37
|
Total current
liabilities
|
|
|
21,408
|
|
|
5,684
|
Loans payable,
net
|
|
|
34,235
|
|
|
39,710
|
Other long-term
liabilities
|
|
|
440
|
|
|
122
|
Total
liabilities
|
|
|
56,083
|
|
|
45,516
|
Total stockholders'
equity
|
|
|
111,231
|
|
|
101,550
|
Total liabilities and
stockholders' equity
|
|
$
|
167,314
|
|
$
|
147,066
|
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SOURCE Aratana Therapeutics, Inc.