0001509190-18-000048.txt : 20181101 0001509190-18-000048.hdr.sgml : 20181101 20181101161729 ACCESSION NUMBER: 0001509190-18-000048 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20181101 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20181101 DATE AS OF CHANGE: 20181101 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: 181153975 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-20181101x8k.htm 8-K 20180930 8K



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): November 1, 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 November 1, 2018, Aratana Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 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 November 1, 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: November 1, 2018

 

 

 

By:

 

 

 

 

 

 

 

 

/s/ Steven St. Peter

 

 

 

 

 

 

Steven St. Peter

 

 

 

 

 

 

 

 

 

 

President and Chief Executive Officer






EX-99.1 2 petx-20181101xex99_1.htm EX-99.1 Exhibit 991

Exhibit 99.1





Aratana Therapeutics Reports Third Quarter 2018 Financial Results



LEAWOOD, Kan., November 1, 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 third quarter 2018 financial results. For the third quarter ended September 30, 2018, Aratana reported total net revenues of $21.6 million and net income of $8.8 million or $0.19 diluted earnings per share. The net revenues for the quarter included a $15.0 million commercial milestone, which resulted in profitability for the quarter.



"It’s evident there is significant enthusiasm among our customers in the pet therapeutics segment of the animal health industry. We believe a majority of U.S. veterinary clinics have already purchased two or more of our therapeutics," stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. "We are especially pleased with the strong performance of Galliprant, which in addition to gaining market share, also earned Aratana its first commercial milestone.”



Business Updates

·

Aratana recorded ENTYCE®  (capromorelin oral solution) net product sales of $1.3 million in the third quarter of 2018. While ENTYCE net product sales to distributors remained consistent with net product sales generated in the prior quarter, in target accounts served by Aratana’s sales team, purchases have increased sequentially quarter-over-quarter. Approximately half of the approximately 25,000 veterinary clinics in the United States have ordered ENTYCE, an appetite stimulant for dogs, although nearly half of net product sales are from the clinics where Aratana’s sales team has had direct interactions. The Company plans to continue its efforts to build the inappetence market through education and extending duration of ENTYCE therapy.

·

In the third quarter of 2018, the Company reported $1.9 million of NOCITA® (bupivacaine liposome injectable suspension) net product sales compared to $0.7 million in the third quarter of 2017. NOCITA provides local post-operative analgesia for certain canine and feline surgeries and continues to show sequential growth primarily due to strong re-order rates. Aratana believes the sequential growth is also correlated to strong brand awareness and satisfaction among surgeons.

·

In August 2018, the Company received FDA approval expanding the NOCITA label as a peripheral nerve block to provide regional post-operative analgesia following onychectomy in cats. Results from a study in client-owned cats showed NOCITA demonstrated a statistically significant improvement in pain evaluation success rates and was well-tolerated. NOCITA is currently available in a 20 mL vial size and Aratana anticipates commencing the regulatory process to add a 10 mL vial size. If approved, the 10 mL vial size could be available to veterinarians in the fall of 2019. 

·

Aratana recorded $18.4 million in licensing and collaboration revenue in the third quarter of 2018 for GALLIPRANT® (grapiprant tablets) from Elanco Animal Health, Inc., which included a $15.0 million commercial milestone for GALLIPRANT net product sales exceeding $35.0 million. Licensing and collaboration revenue also included $3.4 million of revenue generated from Elanco’s net product sales of GALLIPRANT of approximately $18.0 million. During the third quarter of 2018, Elanco introduced re-supply of the 100mg SKUs. According to third-party market research conducted through August 2018, GALLIPRANT continues to grow market share in a competitive category and is the leading branded NSAID prescribed by veterinarians. Under the collaboration agreement with Elanco, the Company is entitled to two additional payments totaling up to $60 million upon the achievement of certain sales milestones.

·

In August 2018, Aratana submitted the Target Animal Safety technical section to the FDA’s Center for Veterinary Medicine for AT-002 (capromorelin) for cats. Target enrollment for the pivotal field effectiveness study evaluating the therapeutic candidate for weight management in cats with chronic kidney disease is anticipated to be completed in mid-2019. Aratana anticipates submitting the technical section for chemistry, manufacturing and controls (CMC) in 2018.



 

 


 

 

Financial Results

The Company recorded net income of $8.8 million for the third quarter of 2018 or $0.19 diluted earnings per share compared to a net loss of $8.9 million or $0.21 diluted net loss per share for the corresponding quarter of 2017. Aratana reported $21.6 million in net revenues for the quarter ended September 30, 2018 compared to $6.2 million in net revenues in the third quarter of 2017. In the third quarter of 2018, net revenues included a $15.0 million one-time GALLIPRANT commercial milestone; $3.4 million in licensing and collaboration revenue for net product sales of GALLIPRANT by Elanco; $1.9 million in net product sales of NOCITA; and $1.3 million in net product sales of ENTYCE. In comparison, in the third quarter of 2017, the Company recognized $3.2 million in product sales of GALLIPRANT related to the sale of finished goods to Elanco; $1.2 million in GALLIPRANT licensing and collaboration revenue; a one-time payment of $1.0 million for the manufacturing transfer of GALLIPRANT to Elanco; and $0.7 million in net product sales of NOCITA.



The cost of product sales totaled $2.2 million in the third quarter of 2018 compared to $3.7 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.



Research and development expenses totaled $1.5 million in the third quarter of 2018 compared to $3.2 million for the corresponding period in 2017. The decrease in research and development expenses was primarily due to fewer on-going pivotal studies compared to the corresponding period in 2017.



Selling, general and administrative expenses totaled $7.0 million for the third quarter ended September 30, 2018 compared to $6.9 million for the same period in 2017.



As of September 30, 2018, Aratana had approximately $56.4 million in cash, cash equivalents, restricted cash and short-term investments, which includes net proceeds in the third quarter from its at-the-market sales agreement of approximately $4.9 million. The one-time $15.0 million GALLIPRANT commercial milestone earned from Elanco is expected to be paid to Aratana in the fourth quarter of 2018. The Company continues to make its scheduled principal debt payments, which are approximately $5.3 million for the remainder of 2018. Aratana anticipates its cash, cash equivalents, restricted cash and short-term investments to be approximately $60.0 million at 2018 year-end.





Webcast & Conference Call Details

The Company will host a live conference call on Friday, November 2, 2018 at 8:30 a.m. ET to discuss financial results from the third quarter ended September 30, 2018.



Interested participants and investors may access the audio webcast (https://www.webcaster4.com/Webcast/Page/421/28063)  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 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 10125816:

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 (https://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 local infiltration injection in dogs only. Do not use in dogs younger than 5 months of age, dogs that are pregnant, lactating or intended for breeding. 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 (https://www.aratana.com/wp-content/uploads/2016/08/NOCITA-Prescribing-Information.pdf)  for more detail.



NOCITA® (bupivacaine liposome injectable suspension) is for use as a peripheral nerve block in cats only. Do not use in cats younger than 5 months of age, that are pregnant, lactating, or intended for breeding. Do not administer by intravenous or intra‐arterial injection. Adverse reactions in cats may include elevated body temperature, infection or chewing/licking at the surgical site. Avoid concurrent use with bupivacaine HCl, lidocaine or other amide local anesthetics. Please see the full Prescribing Information (https://www.aratana.com/wp-content/uploads/2018/08/NOCITA-Package-Insert.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; the expected timing of payment of the $15.0 million commercial milestone earned in the third quarter of 2018; potential future milestone payments; our anticipated use of cash in the remainder of 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; timing of anticipated study results; increased market recognition of and demand for our therapeutics; efforts to build the inappetence market; potential use and timing of availability of the 10 mL vial size of NOCITA; and statements regarding the Company's efforts, plans and opportunities, including, without limitation, advancing our therapeutic candidates and offering safe and effective therapeutics that elevate the standard of care in veterinary medicine.



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

 

Nine Months Ended



 

September 30,

 

September 30,



 

2018

 

2017

 

2018

 

2017

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Licensing and collaboration revenue

 

$

18,385 

 

$

2,192 

 

$

21,982 

 

$

3,899 

Product sales

 

 

3,170 

 

 

3,971 

 

 

8,524 

 

 

11,217 

Total revenues

 

 

21,555 

 

 

6,163 

 

 

30,506 

 

 

15,116 

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

2,172 

 

 

3,690 

 

 

4,013 

 

 

10,475 

Royalty expense

 

 

1,346 

 

 

441 

 

 

3,067 

 

 

1,117 

Research and development

 

 

1,507 

 

 

3,220 

 

 

5,288 

 

 

11,574 

Selling, general and administrative

 

 

7,010 

 

 

6,910 

 

 

21,418 

 

 

21,323 

Amortization of intangible assets

 

 

129 

 

 

85 

 

 

388 

 

 

235 

In-process research and development

 

 

 —

 

 

 —

 

 

500 

 

 

 —

Total costs and expenses

 

 

12,164 

 

 

14,346 

 

 

34,674 

 

 

44,724 

Income (loss) from operations

 

 

9,391 

 

 

(8,183)

 

 

(4,168)

 

 

(29,608)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

159 

 

 

138 

 

 

441 

 

 

311 

Interest expense

 

 

(716)

 

 

(870)

 

 

(2,357)

 

 

(2,601)

Other expense, net

 

 

(1)

 

 

(5)

 

 

(4)

 

 

(14)

Total other expense

 

 

(558)

 

 

(737)

 

 

(1,920)

 

 

(2,304)

Net income (loss)

 

$

8,833 

 

$

(8,920)

 

$

(6,088)

 

$

(31,912)

Net income (loss) per share, basic and diluted

 

$

0.19 

 

$

(0.21)

 

$

(0.13)

 

$

(0.80)

Weighted average shares outstanding, basic

 

 

47,310,408 

 

 

42,445,553 

 

 

46,128,197 

 

 

39,820,573 

Weighted average shares outstanding, diluted

 

 

47,485,384 

 

 

42,445,553 

 

 

46,128,197 

 

 

39,820,573 



 

 


 

 



ARATANA THERAPEUTICS, INC.

Consolidated Balance Sheets (Unaudited)

(Amounts in thousands)





 

 

 

 

 

 



 

 

 

 

 

 



 

September 30, 2018

 

December 31, 2017

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash, cash equivalents and short-term investments

 

$

56,021 

 

$

67,615 

Accounts receivable, net and prepaid expenses and other current assets

 

 

21,315 

 

 

4,048 

Inventories

 

 

13,732 

 

 

13,576 

Total current assets

 

 

91,068 

 

 

85,239 

Property and equipment, net

 

 

811 

 

 

1,166 

Goodwill

 

 

40,846 

 

 

41,295 

Intangible assets, net

 

 

6,228 

 

 

6,616 

Restricted cash

 

 

351 

 

 

350 

Other long-term assets

 

 

499 

 

 

526 

Total assets

 

$

139,803 

 

$

135,192 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable, accrued expenses and other current liabilities

 

$

5,905 

 

$

11,163 

Licensing and collaboration commitment

 

 

200 

 

 

7,000 

Current portion – loans payable

 

 

22,583 

 

 

17,333 

Total current liabilities

 

 

28,688 

 

 

35,496 

Loans payable, net

 

 

2,660 

 

 

19,492 

Other long-term liabilities

 

 

60 

 

 

70 

Total liabilities

 

 

31,408 

 

 

55,058 

Total stockholders’ equity

 

 

108,395 

 

 

80,134 

Total liabilities and stockholders’ equity

 

$

139,803 

 

$

135,192