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8-K - 8-K - ANTARES PHARMA, INC.atrs-8k_20160308.htm

Exhibit 99.1

 

 

 

  

 

 

 

 

ANTARES PHARMA REPORTS FOURTH QUARTER AND FULL YEAR

2015 OPERATING AND FINANCIAL RESULTS

 

FOURTH QUARTER AND FULL YEAR REVENUES DRIVEN BY OTREXUP™ AND EPINEPHRINE AUTO INJECTOR DEVICE SALES

 

EIGHTH CONSECUTIVE QUARTER OF INCREASED PRODUCT REVENUE GROWTH

 

 

EWING, NJ, March 8, 2016 -- Antares Pharma, Inc. (NASDAQ: ATRS) today reported operating progress and financial results for the fourth quarter and full year ended December 31, 2015.  The Company reported revenue of $11.8 million for the fourth quarter of 2015 and $45.7 million for the full year ended December 31, 2015.  Net loss per share was $0.04 and $0.14 for the fourth quarter and full year 2015.  Antares ended the year with $47.9 million in cash and investments and no debt.

 

“I am pleased to announce results for the Company which feature a 72% increase in total revenues from a variety of sources for the year.  We continued growing the product sales portion of total revenue, recording our eighth consecutive quarterly increase,” said Robert F. Apple, President and Chief Executive Officer of the Company.   “The fourth quarter also brought continued progress from our pipeline with the approval of our abbreviated new drug application for Sumatriptan Injection USP for the acute treatment of migraine and cluster headache. As we look ahead to 2016, we believe continued revenue growth and progress in our pipeline should create increased shareholder value.”

 

Fourth Quarter 2015 and Recent Highlights

 

 

·

Increased the number of quarterly prescriptions written to 9,060 and unique prescribers of OTREXUP™ (methotrexate) injection to approximately 2,000 physicians at the end of the fourth quarter as compared to 6,738 prescriptions and approximately 1,400 physicians at the end of the fourth quarter of 2014. The Company more than doubled prescriptions written by generating approximately 33,000 for the full year 2015 as compared to 15,700 for the same period in 2014, according to Symphony Health Solutions.

 

 

·

Announced that the U.S. Food and Drug Administration (FDA) approved our Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache.

 

 

·

Delivered $4.9 million in pre-launch epinephrine devices to Teva in the fourth quarter.

 

 

·

Identified our previously undisclosed Alliance Business partner as AMAG Pharmaceuticals.  Antares is developing a subcutaneous auto injector for their product Makena, a prescription hormone medicine (progestin) used to lower the risk of preterm birth in women who are pregnant with one baby and who have delivered one baby too early in the past.  Current administration of Makena is done intramuscularly through a 21 gauge needle.

 

 

·

Completed ahead of schedule, enrolment in a dose-blinded, multiple-dose, concentration controlled 26-week safety and pharmacokinetic study of QuickShot® Testosterone (QS T) administered subcutaneously once each week to adult males with hypogonadism.  This supplemental safety study is scheduled for completion in May 2016.

 

 


 

 

·

Announced that the last patient had completed treatment in the dose-blinded, multiple-dose 52 week Phase 3 study to evaluate the efficacy and safety of QuickShot® Testosterone (QS T) administered subcutaneously once each week to adult males with hypogonadism.  

 

 

·

Appointed Robert F. Apple to the position of President and Chief Executive Officer.   Mr. Apple most recently served as the Company’s Executive Vice President and Chief Operating Officer.  

 

 

·

Our partner, Teva, received a complete response letter (CRL) from the FDA on February 23, 2016 related to their epinephrine auto injector ANDA.  According to Teva, the FDA identified certain major deficiencies.  Teva is evaluating the CRL and intends to submit a response.  Due to the major nature of the CRL, Teva expects that its epinephrine product will be substantially delayed from their previously anticipated second half 2016 launch date and that any launch will not take place before 2017.

 

Fourth Quarter and Year End 2015 Financial Results

 

Total revenue was $11.8 million and $45.7 million for the three months and year ended December 31, 2015, respectively, compared to $8.4 million and $26.5 million for the comparable periods in 2014. See Table 1 attached for further details on revenues.  

 

Product sales represent sales of our proprietary products and devices or device components to our partners.  Product sales were $9.0 million and $27.5 million for the three months and year ended December 31, 2015, respectively, compared to $4.5 million and $13.2 million for the comparable periods in 2014.  The increase in product sales for the three months and full year ended December 31, 2015 over the same periods in 2014 was primarily driven by the continued growth of OTREXUP™ and the sale of pre-launch quantities of the epinephrine auto injector to Teva.

 

Development revenues represent amounts earned under arrangements with partners in which we develop new products on their behalf.  Frequently, we receive payments from our partners that are initially deferred and recognized as revenue over a development period or upon completion of defined deliverables.  Development revenue was $0.9 million and $8.9 million for the three months and year ended December 31, 2015, respectively, compared to $2.3 million and $7.2 million for the comparable periods in 2014.

 

Licensing revenues represent the amounts recognized from up-front or milestone payments received from partners that are initially deferred and recognized over the life of our agreements.  Licensing revenue was $1.1 million and $7.2 million for the three months and year ended December 31, 2015, respectively, compared to $0.9 million and $3.7 million for the comparable periods in 2014.  The increase in the full year 2015 licensing revenue is primarily related to final recognition of deferred revenue in connection with the termination of our promotion and license agreement with LEO Pharma, Inc.

 

Royalty revenue is recognized primarily from the in-market sales of products sold by our partners.  Royalty revenue was $0.8 million and $2.0 million for the three months and year ended December 31, 2015, respectively, compared to $0.7 million and $2.4 million for the comparable periods in 2014.  

 

Total gross profit increased in the fourth quarter of 2015 to $5.8 million compared to $3.0 million in the same period in 2014 and increased for the full year to $26.2 million in 2015 compared to $15.3 million in 2014.  

 

Total operating expenses were approximately $12.3 million and $13.0 million for the fourth quarters of 2015 and 2014, respectively, and approximately $46.7 million and $50.4 million for the years ended December 31, 2015 and 2014, respectively.  The decreases in operating expenses were driven by a reduction in costs associated with the OTREXUP launch as well as a reduction in legal fees incurred in connection with the Medac litigation.

 

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Net loss was approximately $6.6 million in the fourth quarter ended December 31, 2015 compared to $10.1 million for the same period in 2014 and $20.7 million for the year ending December 31, 2015 compared to $35.2 million for the full year in 2014.  Net loss per share was $0.04 for the quarter ended December 31, 2015 compared to $0.08 for the same quarter in 2014.  Net loss per share was $0.14 and $0.27 for the years ended December 31, 2015 and 2014, respectively.  

 

At December 31, 2015, cash and investments totalled approximately $47.9 million compared to approximately $40.0 million at December 31, 2014.

 

Conference Call, Call Replay and Webcast

 

Antares executives will provide a Company update and review fourth quarter and full year 2015 financial results via webcast and conference call on Tuesday, March 8, 2016, at 8:30 a.m. ET (Eastern Time). The webcast of the conference call, which will include a slide presentation, can be accessed through the link located on the “ATRS Investor Information” section of the Company’s website (www.antarespharma.com) under the “Webcast” tab.  Alternatively, callers may participate in the audio portion of the conference call by dialing 1-888-455-2296 (US), or 1-719-457-2628 (International).  Callers should reference the Antares Pharma conference call or conference identification code 7743006. Callers can access the slide presentation on the “ATRS Investor Information” section of the Company’s website under the “Presentations” tab. Webcast and telephone replays of the conference call will be available from 11:30 a.m. ET on Tuesday, March 8, 2016, through 11:30 a.m. ET on Wednesday, March 23, 2016. To access the replay, callers should dial 1-888-203-1112 (US) or 1-719-457-0820 (International) and enter passcode 7743006.  

 

About Antares Pharma

 

Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP™ (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy, and has recently received a therapeutically equivalent approval for VIBEX® Sumatriptan USP for the acute treatment of migraine and cluster headache in the U.S.  The Company's technology platforms include VIBEX® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has a multi-product license and development deal with Teva Pharmaceutical Industries, Ltd. that includes VIBEX® epinephrine, exenatide multi-dose pen, and another undisclosed multi-dose pen which have not been approved.  Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V.

 

 

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

 

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: the timing of the launch of Vibex Sumatriptan Injection USP and the amount of revenue from the same, the timing and results of the phase 3 studies for QuickShot® Testosterone (QS T) and acceptance of the data by the U.S. Food and Drug Administration (FDA); the Company’s ability to successfully complete a New Drug Application for QS T and submit to the FDA and approval of the same by the FDA; Teva’s ability to adequately and timely respond to the FDA’s complete response letter (CRL) related to their epinephrine auto injector ANDA and FDA approval of the same, the timing and therapeutic equivalence rating thereof, and any revenue pre or post FDA approval; FDA action with respect to Teva’s ANDA for the Exenatide pen; continued growth of prescriptions and sales of OTREXUP™;  the timing and results of research projects, clinical trials,  and product candidates in development including the development

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project with AMAG Pharmaceuticals for a subcutaneous auto injector for their product Makena and Teva’s undisclosed Pen 1 project; actions by the FDA or other regulatory agencies with the respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2015, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

 

 

Contacts:

Jack Howarth

Vice President, Corporate Affairs

609-359-3016

jhowarth@antarespharma.com

TABLES FOLLOW

 

 


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ANTARES PHARMA, INC.

Table 1 - CONSOLIDATED REVENUE DETAILS

(amounts in thousands, except for percentages)

(unaudited)

 

 

 

 

Three Months Ended 

December 31,

 

 

Increase

 

 

Year Ended December 31,

 

 

Increase

 

 

 

2015

 

 

2014

 

 

(Decrease)

 

 

2015

 

 

2014

 

 

(Decrease)

 

OTREXUP™

 

$

3,307

 

 

$

2,818

 

 

 

17%

 

 

$

13,250

 

 

$

7,310

 

 

 

81%

 

Needle-free injector devices and components

 

 

863

 

 

 

813

 

 

 

6%

 

 

 

4,203

 

 

 

4,409

 

 

 

(5)%

 

Auto injector and pen injector devices

 

 

4,873

 

 

 

840

 

 

 

480%

 

 

 

10,080

 

 

 

1,477

 

 

 

582%

 

Total product sales

 

 

9,043

 

 

 

4,471

 

 

 

102%

 

 

 

27,533

 

 

 

13,196

 

 

 

109%

 

Development revenue

 

 

868

 

 

 

2,292

 

 

 

(62)%

 

 

 

8,892

 

 

 

7,246

 

 

 

23%

 

Licensing revenue

 

 

1,130

 

 

 

925

 

 

 

22%

 

 

 

7,242

 

 

 

3,709

 

 

 

95%

 

Royalties

 

 

763

 

 

 

714

 

 

 

7%

 

 

 

1,991

 

 

 

2,351

 

 

 

(15)%

 

Total revenue

 

$

11,804

 

 

$

8,402

 

 

 

40%

 

 

$

45,658

 

 

$

26,502

 

 

 

72%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANTARES PHARMA, INC.

Table 2 - CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

(amounts in thousands except per share amounts)

(unaudited)

 

 

 

 

For the Three Months Ended

 

 

For the Year Ended

 

 

 

December 31,

 

 

December 31,

 

 

 

2015

 

 

2014

 

 

2015

 

 

2014

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

9,043

 

 

$

4,471

 

 

$

27,533

 

 

$

13,196

 

Development revenue

 

 

868

 

 

 

2,292

 

 

 

8,892

 

 

 

7,246

 

Licensing revenue

 

 

1,130

 

 

 

925

 

 

 

7,242

 

 

 

3,709

 

Royalties

 

 

763

 

 

 

714

 

 

 

1,991

 

 

 

2,351

 

Total revenue

 

 

11,804

 

 

 

8,402

 

 

 

45,658

 

 

 

26,502

 

Cost of revenue

 

 

5,975

 

 

 

5,423

 

 

 

19,458

 

 

 

11,237

 

Gross profit

 

 

5,829

 

 

 

2,979

 

 

 

26,200

 

 

 

15,265

 

Research and development

 

 

5,642

 

 

 

5,735

 

 

 

19,731

 

 

 

18,638

 

Selling, general and administrative

 

 

6,677

 

 

 

7,284

 

 

 

26,931

 

 

 

31,740

 

Total operating expenses

 

 

12,319

 

 

 

13,019

 

 

 

46,662

 

 

 

50,378

 

Operating loss

 

 

(6,490

)

 

 

(10,040

)

 

 

(20,462

)

 

 

(35,113

)

Other income (expense)

 

 

39

 

 

 

(8

)

 

 

(22

)

 

 

(14

)

Net loss before income taxes

 

 

(6,451

)

 

 

(10,048

)

 

 

(20,484

)

 

 

(35,127

)

Income tax provision

 

 

175

 

 

 

25

 

 

 

175

 

 

 

25

 

Net loss

 

$

(6,626

)

 

$

(10,073

)

 

$

(20,659

)

 

$

(35,152

)

Basic and diluted net loss per common share

 

$

(0.04

)

 

$

(0.08

)

 

$

(0.14

)

 

$

(0.27

)

Basic and diluted weighted average common shares outstanding

 

 

154,829

 

 

 

131,694

 

 

 

146,594

 

 

 

130,550

 


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ANTARES PHARMA, INC.

Table 3 – CONSOLIDATED CONDENSED BALANCE SHEETS

(amounts in thousands)

(unaudited)

 

 

 

 

December 31,

 

 

December 31,

 

 

 

2015

 

 

2014

 

Assets

 

 

 

 

 

 

 

 

Cash and investments

 

$

47,911

 

 

$

40,031

 

Accounts receivable

 

 

7,952

 

 

 

3,510

 

Inventories

 

 

5,724

 

 

 

5,860

 

Equipment, molds, furniture and fixtures, net

 

 

14,793

 

 

 

10,829

 

Patent rights, net

 

 

2,435

 

 

 

2,885

 

Goodwill

 

 

1,095

 

 

 

1,095

 

Other assets

 

 

4,652

 

 

 

4,563

 

Total Assets

 

$

84,562

 

 

$

68,773

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

11,675

 

 

$

15,707

 

Deferred revenue

 

 

5,844

 

 

 

11,870

 

Stockholders’ equity

 

 

67,043

 

 

 

41,196

 

Total Liabilities and Stockholders’ Equity

 

$

84,562

 

 

$

68,773

 

 

 

 

 

 

 

 

 

 

 

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