0001509190-18-000021.txt : 20180503 0001509190-18-000021.hdr.sgml : 20180503 20180503161129 ACCESSION NUMBER: 0001509190-18-000021 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20180503 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20180503 DATE AS OF CHANGE: 20180503 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARATANA THERAPEUTICS, INC. CENTRAL INDEX KEY: 0001509190 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 383826477 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35952 FILM NUMBER: 18803874 BUSINESS ADDRESS: STREET 1: 11400 TOMAHAWK CREEK PARKWAY, SUITE 340 CITY: LEAWOOD STATE: KS ZIP: 66211 BUSINESS PHONE: 913.353.1000 MAIL ADDRESS: STREET 1: 11400 TOMAHAWK CREEK PARKWAY, SUITE 340 CITY: LEAWOOD STATE: KS ZIP: 66211 8-K 1 petx-20180503x8k.htm 8-K 20180331



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549



FORM 8-K



CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): May 3, 2018

 

ARATANA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)







 

 

 

 

 

 

 

 

 

Delaware

 

001-35952

 

38-3826477

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)



11400 Tomahawk Creek Parkway, Suite 340, Leawood, KS 66211

(Address of principal executive offices) (Zip Code)

(913) 353-1000

(Registrant’s telephone number, include area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:



Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)







 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)





 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 



 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).



Emerging growth company  



If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  


 

Item 2.02.                                        Results of Operations and Financial Condition.

 

On May 3, 2018, Aratana Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2018. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. 

The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits.





 

 



 

(d)

Exhibits:

 

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release issued on May 3, 2018.

 

 

 






 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ARATANA THERAPEUTICS, INC.

 

 

 

 

Date: May 3, 2018

 

 

 

By:

 

 

 

 

 

 

 

 

/s/ Steven St. Peter

 

 

 

 

 

 

Steven St. Peter

 

 

 

 

 

 

 

 

 

 

President and Chief Executive Officer




EX-99.1 2 petx-20180503xex99_1.htm EX-99.1 Exhibit 991

Exhibit 99.1



Aratana Therapeutics Reports First Quarter 2018 Financial Results



LEAWOOD, Kan., May 3, 2018 —  Aratana Therapeutics, Inc. (Nasdaq: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative therapeutics for dogs and cats, announced its first quarter 2018 financial results. In the first quarter ended March 31, 2018, Aratana reported total net revenues of $4.0 million and a net loss of $8.5 million or $0.19 diluted loss per share.



“We are encouraged by the continued growth of Nocita and Galliprant, as well as these initial months of Entyce penetration in veterinary clinics,” stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. “With respect to Entyce, we remain focused on building the canine inappetence market. Our efforts include educating veterinarians about acute and chronic inappetence, and utilizing Entyce as a new therapeutic tool. Veterinarian and customer feedback that we have received has been very positive and we continue to be excited about the potential of Entyce.”



Recent Updates

·

Aratana recorded ENTYCE® (capromorelin oral solution) net product sales of $0.8 million in the first quarter of 2018. The previous quarter had included initial distributor stocking orders, and hence, reported revenues were sequentially lower in the first quarter of 2018 compared to the previous quarter. However, move-out of ENTYCE from distributors to veterinary clinics was higher in the first quarter of 2018 compared to the previous quarter. The Company anticipates continued growth and a tighter correlation between shipments to distributors and move-out to veterinary clinics throughout 2018. Aratana believes that approximately one-third of veterinary clinics in the United States have already ordered ENTYCE, and while Aratana continues to be focused on initial clinic penetration, it is increasingly focused on re-order rates and average days of therapy to further grow net product sales.

·

In the first quarter of 2018, the Company reported $1.5 million of NOCITA® (bupivacaine liposome injectable suspension) net product sales. The therapeutic, which provides local post-operative analgesia for cranial cruciate ligament surgery in dogs, continues to show sequential growth due to new account penetration and strong re-order rates.

·

Aratana recorded $1.7 million in licensing and collaboration revenue in the first quarter of 2018 from Elanco Animal Health (a division of Eli Lilly & Co.) for GALLIPRANT® (grapiprant tablets). GALLIPRANT, which is for the control of pain and inflammation associated with osteoarthritis in dogs, has quickly established itself as the second-leading therapeutic in a competitive category. Assuming GALLIPRANT quarterly sales remain consistent with the first quarter 2018 sales, Aratana expects to achieve a $15.0 million commercial milestone in 2018. In January 2018, Elanco and Aratana announced GALLIPRANT was granted marketing authorization in the European Union. Aratana is also entitled to receive royalties and milestones related to sales of GALLIPRANT outside-the-United States.

·

In April 2018, the Company received the effectiveness technical section complete letter from the FDA’s Center for Veterinary Medicine (CVM) for AT-003 (bupivacaine liposome injectable suspension) in cats and plans to file a supplemental New Animal Drug Application with CVM in the coming weeks. If approved, the Company anticipates the NOCITA label will be expanded to include its use as a peripheral nerve block to provide regional post-operative analgesia following onychectomy in cats.

·

As is required by the U.S. Department of Agriculture to progress from conditional licensure to full licensure, Aratana has initiated the extended field study for its Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014) at approximately two dozen veterinary oncology practice groups across the United States and study sites have started enrolling dogs.

·

In February 2018, Aratana licensed exclusive, worldwide rights from AskAt Inc. to develop and commercialize AT-019, a potent and innovative EP4 receptor antagonist therapeutic candidate for pain, inflammation and other indications.



 

 


 

 

Financial Results

The first quarter 2018 net loss was $8.5 million or $0.19 diluted loss per share compared to a net loss of $12.6 million or $0.34 diluted loss per share for the corresponding quarter ended March 31, 2017. Aratana reported $4.0 million in net revenues for the quarter ended March 31, 2018 compared to $3.8 million in net revenues in the first quarter of 2017. In the first quarter of 2018, the Company recognized $1.5 million in net product sales of NOCITA, $0.8 million in net product sales of ENTYCE and $1.7 million in licensing and collaboration revenue from Elanco. In comparison, net revenues in the first quarter of 2017 included $2.5 million in GALLIPRANT product sales to Elanco, $0.9 million in licensing and collaboration revenue from Elanco and $0.3 million in net product sales of NOCITA.



The cost of product sales totaled $0.5 million in the first quarter of 2018 in comparison to $3.1 million in the corresponding period in 2017. The decrease year-over-year in cost of product sales was primarily due to Elanco assuming responsibility for GALLIPRANT manufacturing.



Selling, general and administrative expenses totaled $7.7 million for the first quarter ended March 31, 2018 compared to $7.5 million for the same period in 2017. The small increase in the first quarter of 2018 was primarily due to expanded adoption and awareness efforts for the Company’s marketed therapeutics. Aratana continues to expect selling, general and administrative expenses to remain relatively consistent throughout 2018.   



Research and development expenses totaled $2.2 million in the first quarter of 2018 compared to $4.7 million for the corresponding quarter ended March 31, 2017. The decrease in research and development expenses was primarily due to fewer on-going pivotal studies compared to the corresponding period in 2017.



As of March 31, 2018, Aratana had approximately $67.3 million in cash, cash equivalents, restricted cash and short-term investments, which includes net proceeds in the quarter from its at-the-market sales agreement of approximately $15.5 million. During the quarter, Aratana paid approximately $7.2 million for ENTYCE active pharmaceutical ingredient inventories and separately, it made $3.0 million in debt principal payments. Consistent with previous guidance, for the remaining three quarters of 2018, the Company expects approximately $22.0 million of additional cash to be used for on-going operations, as well as another approximately $14.3 million of cash to be used to cover its existing debt principal obligations for the remainder of the year.



Webcast & Conference Call Details

The Company will host a live conference call on Friday, May 4, 2018 at 8:30 a.m. ET to discuss financial results from the first quarter ended March 31, 2018.



Interested participants and investors may access the audio webcast (https://www.webcaster4.com/Webcast/Page/421/25422) 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 first quarter 2018 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 10119437:



1 (877) 344-7529 (U.S.) 
1 (855) 669-9658 (Canada) 
1 (412) 317-0088 (International)





About Aratana Therapeutics

Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative therapeutics for dogs and cats. As a pioneer in pet therapeutics, Aratana’s mission is to deliver safe and effective therapeutics that elevate the standard of care in veterinary medicine. We work with companion animal veterinarians to bring new therapeutics to market that support the needs of pets and their owners. For more information, please visit www.aratana.com.

 

 


 

 

IMPORTANT SAFETY INFORMATION

GALLIPRANT® (grapiprant tablets) is not for use in humans. For use in dogs only. Keep this and all medications out of reach of children and pets. Store out of reach of dogs and other pets in a secured location in order to prevent accidental ingestion or overdose. Do not use in dogs that have a hypersensitivity to grapiprant. If Galliprant is used long term, appropriate monitoring is recommended. Concomitant use of Galliprant with other anti-inflammatory drugs, such as COX-inhibiting NSAIDs or corticosteroids, should be avoided. Concurrent use with other anti-inflammatory drugs or protein-bound drugs has not been studied. The safe use of Galliprant has not been evaluated in dogs younger than 9 months of age and less than 8 lbs (3.6 kg), dogs used for breeding, pregnant or lactating dogs, or dogs with cardiac disease. The most common adverse reactions were vomiting, diarrhea, decreased appetite, and lethargy. Please see full product label or call 1-888-545-5973 for full prescribing information (https://assets.ctfassets.net/0kto1cmw1iq5/5PEbZTfRluMA00u4MaQYUU/8df5bee10c6fa00d378f86de0259c429/galliprantpi.pdf).



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 (http://www.aratana.com/wp-content/uploads/2016/12/ENTYCE-Pkg_Insert-8_5x11-FINAL.pdf?_ga=2.77189909.1895746144.1518451955-445940098.1507233446) for more detail.



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 (http://www.aratana.com/wp-content/uploads/2016/08/NOCITA-Prescribing-Information.pdf)  for more detail.



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 anticipated financial performance; future milestone payments; 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 regarding the timing and filing of a supplemental NADA for NOCITA and expanding the NOCITA label; expectations regarding trends in selling, general and administrative expenses; 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 or termination of the development of grapiprant therapeutic candidates and commercialization of grapiprant products that may arise from termination of or failure to perform under the 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 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, 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 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



 

March 31,



 

2018

 

2017

Revenues

 

 

 

 

 

 

Licensing and collaboration revenue

 

$

1,706 

 

$

903 

Product sales

 

 

2,337 

 

 

2,892 

Total revenues

 

 

4,043 

 

 

3,795 

Costs and expenses

 

 

 

 

 

 

Cost of product sales

 

 

536 

 

 

3,094 

Royalty expense

 

 

806 

 

 

323 

Research and development

 

 

2,205 

 

 

4,654 

Selling, general and administrative

 

 

7,699 

 

 

7,495 

Amortization of intangible assets

 

 

130 

 

 

64 

In-process research and development

 

 

500 

 

 

 —

Total costs and expenses

 

 

11,876 

 

 

15,630 

Loss from operations

 

 

(7,833)

 

 

(11,835)

Other income (expense)

 

 

 

 

 

 

Interest income

 

 

141 

 

 

85 

Interest expense

 

 

(853)

 

 

(860)

Other expense, net

 

 

(3)

 

 

(2)

Total other expense

 

 

(715)

 

 

(777)

Net loss

 

$

(8,548)

 

$

(12,612)

Net loss per share, basic and diluted

 

$

(0.19)

 

$

(0.34)

Weighted average shares outstanding, basic and diluted

 

 

44,788,068 

 

 

36,711,601 



 

 


 

 



ARATANA THERAPEUTICS, INC.

Consolidated Balance Sheets (Unaudited)

(Amounts in thousands)





 

 

 

 

 

 



 

 

 

 

 

 



 

March 31, 2018

 

December 31, 2017

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash, cash equivalents and short-term investments

 

$

66,925 

 

$

67,615 

Accounts receivable, net and prepaid expenses and other current assets

 

 

3,701 

 

 

4,048 

Inventories

 

 

13,952 

 

 

13,576 

Total current assets

 

 

84,578 

 

 

85,239 

Property and equipment, net

 

 

1,047 

 

 

1,166 

Goodwill

 

 

41,683 

 

 

41,295 

Intangible assets, net

 

 

6,486 

 

 

6,616 

Restricted cash

 

 

350 

 

 

350 

Other long-term assets

 

 

528 

 

 

526 

Total assets

 

$

134,672 

 

$

135,192 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable, accrued expenses and other current liabilities

 

$

4,804 

 

$

11,163 

Licensing and collaboration commitment

 

 

200 

 

 

7,000 

Current portion – loans payable

 

 

20,083 

 

 

17,333 

Total current liabilities

 

 

25,087 

 

 

35,496 

Loans payable, net

 

 

13,882 

 

 

19,492 

Other long-term liabilities

 

 

67 

 

 

70 

Total liabilities

 

 

39,036 

 

 

55,058 

Total stockholders’ equity

 

 

95,636 

 

 

80,134 

Total liabilities and stockholders’ equity

 

$

134,672 

 

$

135,192