Aratana Therapeutics Reports Third Quarter 2014 Results

KANSAS CITY, Kan., Nov. 10, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals, today announced its third quarter 2014 results.

"We continue to execute on multiple fronts," stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. "This quarter, we advanced our priority programs, expanded our portfolio to other important diseases and improved our balance sheet."

Aratana's diversified portfolio consists of more than 18 therapeutic candidates: two have received conditional licensure, one has been submitted for licensure, more than a dozen are in active development and several additional candidates are in pre-development.

Recent Highlights:

  • AT-001 (grapiprant, EP4 receptor antagonist for osteoarthritis pain): Aratana completed enrollment in the pivotal field effectiveness study in client-owned dogs at the end of October; Aratana continues to anticipate top-line results by the end of 2014 and marketing approval in 2016.
  • AT-002 (capromorelin, ghrelin agonist for appetite stimulation): Aratana continues to enroll the pivotal field effectiveness trial in client-owned dogs and continues to anticipate top-line results in the first quarter of 2015 and marketing approval in 2016.
  • AT-003 (bupivacaine extended release injectable suspension for post-operative pain): During the quarter, Aratana announced positive results of a pilot study in client-owned dogs and met with the FDA to discuss the design of the pivotal field effectiveness which it expects to start by the end of 2014. Aratana continues to anticipate top-line results in the second quarter of 2015 and marketing approval in 2016.
  • In October 2014, investigators presented initial clinical trial results at the Veterinary Cancer Society meeting on AT-004, our partnered product in the U.S. and Canada to aid in the treatment of B-cell lymphoma.
  • Aratana continues to enroll dogs in two studies investigating the use of AT-005, the Company's conditionally licensed monoclonal antibody to aid in the treatment of T-cell lymphoma, in combination with chemotherapy. Aratana commenced a limited commercial introduction of AT-005 in the fourth quarter of 2014. After receipt of a full license for AT-005 from the United States Department of Agriculture (USDA), which Aratana continues to anticipate in 2015, the Company plans to further expand commercial availability.
  • During the third quarter of 2014, the Company received positive results from the recently closed study of AT-006, the Company's partnered antiviral for treatment of ocular lesions associated with feline ocular herpes infection.  The Company anticipates that the study results will assist in designing a plan for concurrent U.S. and EU product development.
  • In October 2014, Aratana completed an exclusive license for its AT-Gamma option program, now known as AT-018, with Atopix Therapeutics Ltd. The Company anticipates initiating a pilot study to treat atopic dermatitis in dogs in early 2015.

Financial Results:
For the three months ended September 30, 2014, Aratana reported a net loss of ($10.1) million, or ($0.35) basic earnings per share, compared to a loss of ($4.7) million for the same period in 2013.  For the nine months ended September 30, 2014, the Company reported a net loss of ($28.6) million, or ($1.01) basic earnings per share versus ($11.4) million for the same period in 2013.

The Company reported revenue of $0.04 million for the three months ended September 30, 2014 and a total of $0.5 million in revenue for the first nine months of 2014.  In the third quarter of 2014, the revenue was primarily related to the recognition of license and collaboration fees and manufacturing services related to AT-004, the B-cell monoclonal antibody for lymphoma. For the nine month period, the revenue also included R&D collaboration revenue from AT-006, the antiviral for treatment of ocular lesions associated with feline ocular herpes infection.

Research and development expenses totaled $6.1 million for the three months ended September 30, 2014 compared to $3.2 million for the third quarter of 2013.  For the nine months ended September 30, 2014, research and development expenses totaled $13.9 million compared to $7.8 million for the same period in 2013.  The increase in research and development expenses was due primarily to advancing the development of the pipeline programs as noted above, as well as the increase in the number of products in development as a result of the Vet Therapeutics and Okapi Sciences acquisitions and other licensing arrangements.

During 2014, the Company has increased its development portfolio by licensing rights to novel technology.  As of September 30, 2014, the Company recorded in-process R&D of $1.2 million to obtain licenses for AT-014 for the treatment of osteosarcoma in dogs, three additional cancer immunotherapy products for the treatment of other types of cancer and AT-016 for allogeneic stem cell therapy technology for the treatment of osteoarthritis in dogs.

During the three months ended September 30, 2014, general and administrative expenses were $3.9 million as compared to $1.4 million for the same period in 2013. For the nine months ended September 30, 2014, general and administrative expenses were $12.9 million as compared to $3.9 million for the same period in 2013. The increases were associated primarily to costs associated with becoming a public company, increased professional fees associated with acquisitions, and the addition of general operating expenses related to the San Diego, California and Leuven, Belgium entities in 2014.  During 2014, Aratana has continued to build a commercial infrastructure, which includes personnel, systems and other costs associated with preparing our products for market introduction.

During the three months ended September 30, 2014, the Company recorded amortization expenses of $0.6 million related to its acquired B-cell (AT-004) and T-cell (AT-005) lymphoma products and $1.7 million for the nine month period ended September 30, 2014.

As of September 30, 2014, Aratana had a total of approximately $108.3 million in cash, cash equivalents, investments and short-term marketable securities. On September 22, 2014, Aratana completed a public offering in which the Company issued and sold 5,175,000 shares of common stock for net proceeds of approximately $44.8 million after deducting underwriting discounts and commissions and other offering expenses.  For the nine months ending September 30, 2014, Aratana used approximately $22.8 million of cash for operating activities.  As reported in the first quarter of 2014, the Company was successful in raising net proceeds of approximately $90.5 million through a public offering of common stock that closed in February 2014.  The proceeds were partially used to fund the purchase of Okapi Sciences for approximately $44.4 million and repay $3 million of promissory notes to the former shareholders of Vet Therapeutics.  Including the net proceeds from the public offering completed in September 2014, the Company now believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations through 2016.

The Company will host a conference call at 8:30 a.m. ET on November 11, 2014 to discuss the third quarter 2014 results.  Please find conference details below.

Conference Call and Webcast

Date:    Tuesday, November 11, 2014
Time:    8:30 a.m. Eastern Time

Conference call numbers:
Interested participants and investors may access the conference call by dialing:
    1 (866) 364-3820 (U.S.)
    1 (855) 669-9657 (Canada)
    1 (412) 902-4210 (International)

Webcast:
Accessible via the Investor Relations section of the Company's website at aratana.investorroom.com

A replay of the conference call and webcast will be available for up to 90 days beginning at approximately 10:30 a.m. E.T.  November 11, 2014 by dialing 1 (877) 344-7529 (U.S.),
1 (855) 669-9658 (Canada), 1 (412) 317-0088 (International) Conference ID: 10055885

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.

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