OREANDA-NEWS. Antares Pharma, Inc. (NASDAQ:ATRS) today reported operating and financial results for the second quarter ended June 30, 2016.  The Company reported revenue of $12.2 million and a net loss per share of $0.04 for the second quarter and revenue of $24.5 million and a net loss of $0.09 per share for the first half of 2016.  Product sales, which represent sales of our proprietary products and devices or device components to our partners, rose to $8.7 million for the three months ended June 30, an increase of 49% compared to the second quarter of 2015.

“The Company reported another solid quarter of top-line results which included growth in Otrexup revenue and the delivery of significant quantities of sumatriptan injection USP to our commercial partner Teva,” said Robert F. Apple, President and Chief Executive Officer of the Company.  “In addition to the growth in product sales, I’m also pleased to report that development revenue nearly tripled versus last quarter as we continue to make progress on three important development projects including exenatide and teriparatide with our partner Teva and Makena with our partner AMAG. We believe that this continued quarterly increase in development revenue will ultimately translate into future product and royalty revenue assuming approval of these alliance projects.”

Second Quarter 2016 and Recent Highlights

  • Reported quarterly revenues of $12.2 million including $3.8 million in OTREXUP™ sales, $2.9 million in revenues generated from the delivery of sumatriptan injection single-dose, auto injectors to Teva Pharmaceutical Industries, Ltd. (Teva) and $1.0 million of epinephrine devices to Teva, bringing the cumulative total of pre-launch shipments of these devices to approximately $17.0 million.
     
  • Jointly announced with Teva the commercial availability of sumatriptan injection USP 4 mg and 6 mg for the treatment of acute migraine with or without aura, and acute cluster headaches in adults.
     
  • Increased the number of OTREXUP™ prescriptions by 16% versus the second quarter of 2015, and 9% versus the first quarter of 2016.
     
  • Announced the last patient had been treated in the QST-15-005 supplemental safety study for VIBEX® QuickShot® Testosterone (QST).  Data is due to be reported in the third quarter of 2016 and we continue our efforts to prepare the New Drug Application (NDA) for QST and expect to submit the NDA to the FDA by the end of the fourth quarter of 2016.
     
  • Announced Teva’s settlement of the patent litigation with AstraZeneca and Amylin Pharmaceuticals for the generic version of BYETTA® and a potential launch date of October 15, 2017, pending FDA approval.
     
  • Disclosed the “Pen 1” development project with Teva relates to a generic form of Forteo® (teriparatide [DNA origin] injection), which is an injectable treatment for osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid induced osteoporosis in men and postmenopausal women. Teva’s ANDA was accepted by the FDA and Eli Lilly and Company filed a patent infringement lawsuit against Teva in response to their paragraph IV certification. Teriparatide represents the second ANDA utilizing Antares’ multi-dose pen technology.  Based on available information, Antares believes that Teva may be the “first applicant” to file an ANDA for a generic equivalent of Forteo® and, should Teva’s ANDA be approved, may be entitled to 180 days of generic market exclusivity.

Second Quarter and First Half Financial Results

Total revenue was $12.2 million for the three months ended June 30, 2016, compared to $14.4 million for the comparable period in 2015. For the six months ended June 30, 2016, total revenue was $24.5 million, compared to total revenue of $22.8 million for the six months ended June 30, 2015. During the second quarter of 2015, $5.1 million in previously deferred licensing revenue was recognized due to the termination of the promotion and license agreement with LEO Pharma A/S, while no revenues related to LEO were recognized in 2016. 

Product sales represent sales of our proprietary products and devices or device components to our partners.  Product sales were $8.7 million for the three months ended June 30, 2016, compared to $5.8 million for the comparable period in 2015, and totalled $19.5 million for the six months ended June 30, 2016 compared to $10.5 million in the same period of 2015. The increase in product sales for the three and six months ended June 30, 2016 over the comparable periods of 2015 was primarily driven by the shipment of sumatriptan injection USP to Teva, the sale of pre-launch quantities of epinephrine auto injectors to Teva and continued growth of OTREXUP™.

Development revenue represents 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 $3.3 million and $4.4 million for the three and six months ended June 30, 2016, respectively, compared to $3.0 million and $5.4 million for the comparable periods in 2015.

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 $39 thousand for the three months ended June 30, 2016, compared to $5.2 million for the comparable period in 2015. Licensing revenue for the first half of 2016 totalled $89 thousand compared to $6.1 million for the first half of 2015. The decrease in licensing revenue is primarily related to payments previously received and deferred from LEO Pharma A/S that were fully recognized upon termination of our agreement in June 2015.

Royalty revenue is recognized primarily from the in-market sales of products sold by our partners. Royalty revenue was $0.2 million for the three months ended June 30, 2016, compared to $0.4 million for the comparable period in 2015. Royalty revenue for the first half of 2016 totalled $0.6 million compared to $0.8 million for the first half of 2015.

Total gross profit decreased in the second quarter of 2016 to $4.9 million compared to $9.7 million in the comparable period in 2015. Total gross profit for the first half of 2016 was $10.5 million as compared to $14.4 million in the first half of 2015. The decreases were primarily driven by the payments previously received and deferred from LEO Pharma A/S that were fully recognized as revenue and gross profit upon termination of our agreement in June 2015.

Total operating expenses were $11.0 million in the second quarter of 2016 compared to $11.2 million in the comparable period in 2015. Total operating expenses for the six months ended June 30, 2016 were approximately $24.2 million as compared to $22.6 million for the comparable period in 2015.

Net loss was approximately $6.1 million and $13.7 million for the second quarter and first half of 2016, respectively, compared to $1.5 million and $8.3 million for the comparable periods in 2015.

At June 30, 2016, cash and investments totalled approximately $36.6 million compared to approximately $47.9 million at December 31, 2015.

 

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. The Company and Teva Pharmaceutical Industries, Ltd. (Teva) recently announced the U.S. commercial launch of VIBEX® Sumatriptan Injection USP for the acute treatment of migraine and cluster headache.  Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy. 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 deal with Teva that includes VIBEX® epinephrine, exenatide multi-dose pen, and teriparatide multi-dose pen.  Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V. The Company is also working with AMAG Pharmaceuticals on a subcutaneous method of administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth. For more information, visit www.antarespharma.com.

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: Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP™; the timing and results of the phase 3 studies for QuickShot® Testosterone (QST) and acceptance of the data by the U.S. Food and Drug Administration (“FDA”); the timing and Company’s ability to successfully complete a New Drug Application (“NDA”) for QST,  acceptance of the NDA for QST by the FDA and approval of the same by the FDA; FDA action with respect to Teva’s Abbreviated New Drug Application (“ANDA”) filed for the Exenatide pen (generic version of Byetta) and future revenue from the same; Teva’s ability to adequately and timely respond to the Complete Response Letter received from the FDA for the VIBEX® epinephrine pen ANDA and approval by the FDA of the same, the timing and therapeutic equivalence rating thereof, and any future purchase orders and revenue pre or post FDA approval;; the outcome of the pending patent litigation between Teva Teva and Eli Lilly and Company regarding the Teriparatide multi-dose pen (generic version of Forteo) ; the timing and approval by the FDA of Teva’s ANDA for the Teriparatide multi-dose pen and any future revenue resulting therefrom;;  the timing and results of the development project with AMAG Pharmaceuticals for an auto injector for Makena; the timing and results of research projects, clinical trials,  and product candidates in development; 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.

TABLES FOLLOW

ANTARES PHARMA, INC.
Table 1 – CONSOLIDATED REVENUE DETAILS
(amounts in thousands, except for percentages)
(unaudited)
 
    Three Months Ended
June 30,		     Increase     Six Months Ended
June 30,		     Increase  
    2016     2015     (Decrease)     2016     2015     (Decrease)  
OTREXUP™   $ 3,810     $ 3,346         14 %     $ 7,120     $ 6,350         12 %  
Auto injector and pen injector devices     3,914       1,769         121 %       9,892       1,967         403 %  
Needle-free injector devices and components     966       725         33 %       2,519       2,146         17 %  
Total product sales     8,690       5,840         49 %       19,531       10,463         87 %  
Development revenue     3,267       3,027         8 %       4,366       5,416         (19 %)  
Licensing revenue (1)     39       5,186         (99 %)       89       6,069         (99 %)  
Royalties     232       367         (37 %)       561       820         (32 %)  
Total revenue   $ 12,228     $ 14,420         (15 %)     $ 24,547     $ 22,768         8 %  
                                                         
(1) Licensing revenue for the three and six month periods ended June 30, 2015 included $5.1 million for payments previously received and deferred under a promotion and marketing agreement with LEO Pharma A/S, which were recognized in revenue upon termination of the agreement in June 2015, while no revenues related to LEO were recognized in the three and six month periods ended June 30, 2016.
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 Six Months Ended  
    June  30,     June 30,  
    2016     2015     2016     2015  
Revenue:                                
Product sales   $   8,690       $ 5,840     $ 19,531     $ 10,463  
Development revenue       3,267         3,027       4,366       5,416  
Licensing revenue       39         5,186       89       6,069  
Royalties       232         367       561       820  
Total revenue       12,228         14,420       24,547       22,768  
Cost of revenue       7,318         4,708       14,094       8,382  
Gross profit       4,910         9,712       10,453       14,386  
Research and development       3,948         4,569       9,596       8,947  
Selling, general and administrative       7,014         6,605       14,618       13,642  
Total operating expenses       10,962         11,174       24,214       22,589  
Operating loss       (6,052 )       (1,462 )     (13,761 )     (8,203 )
Other income (expense)       (9 )       (45 )     43       (91 )
Net loss   $   (6,061 )      $ (1,507 )   $ (13,718 )   $ (8,294 )
Basic and diluted net loss per common share   $   (0.04 )     $ (0.01 )   $ (0.09 )   $ (0.06 )
Basic and diluted weighted average common shares outstanding       154,936         144,650       154,897       138,233