Antares Pharma Reports Fourth Quarter and Full Year 2014 Operating and Financial Results

EWING, N.J.–(BUSINESS WIRE)–

Antares Pharma, Inc. (ATRS) today reported operating and
financial results for the fourth quarter and full year ended December
31, 2014. The Company reported record revenue of $8.4 million for the
fourth quarter of 2014 and $26.5 million for the full year ended
December 31, 2014. Net loss per share was $0.08 and $0.27 for the same
periods. Antares ended the year with $40.0 million in cash and
investments and no debt.

“Our vision of growing Antares from a company solely dependent on
licensing and development revenues to a specialty pharmaceutical company
commercializing its own products continues to gain momentum,” said
Eamonn P. Hobbs, President and Chief Executive Officer of the Company.
“We remain focused on growing OTREXUP, planning for future commercial
product opportunities such as QuickShot Testosterone and VIBEX
Sumatriptan, and believe the coming year will feature a number of
catalysts including a potential decision by the FDA on the approvability
and therapeutic equivalence of the VIBEX epinephrine pen ANDA filed by
our partner Teva Pharmaceutical Industries Ltd.”

Fourth Quarter 2014 and Recent Highlights

  • Increased the number of prescriptions to 6,738 and unique prescribers
    of OTREXUP™ (methotrexate) injection to approximately 1,400 physicians
    at the end of the fourth quarter as compared to 5,478 prescriptions
    and approximately 1,000 physicians at the end of the third quarter and
    generated approximately 15,700 prescriptions for the full year 2014,
    according to Symphony Health Solutions.
  • Announced positive top-line pharmacokinetic results that showed that
    the primary endpoint was achieved in the Company’s ongoing,
    multi-center, phase 3 clinical study (QST-13-003) evaluating the
    efficacy and safety of testosterone enanthate administered once-weekly
    by subcutaneous injection using the QuickShot® auto
    injector in testosterone deficient adult males. The Company also
    received written recommendations from the U.S. Food and Drug
    Administration (FDA) related to its clinical development program for
    QuickShot® Testosterone (testosterone enanthate) injection
    (QS T). Based on the number of subjects in previous studies and in the
    current phase 3 study, the Company anticipates that it may need
    approximately 70 additional subjects exposed to QS T for six months.
  • Announced that the FDA had issued a complete response letter regarding
    the Company’s Abbreviated New Drug Application (ANDA) for VIBEX® Sumatriptan
    Injection USP for the acute treatment of migraine, providing revisions
    to labelling and citing minor deficiencies.
  • Disclosed FDA updates to the Company’s collaboration with Teva
    including Teva’s submission of the final amendment to the VIBEX® epinephrine
    pen ANDA in December 2014 and the FDA acceptance of Teva’s filing of
    an ANDA in October 2014 for exenatide, formerly referred to as Teva
    “Pen 2”.
  • Entered into a new development and licence agreement with an
    undisclosed pharmaceutical partner to develop and supply an auto
    injector for an already approved and marketed injectable product in
    need of a life cycle management program.

Fourth Quarter and Year End 2014 Financial Results

Total revenue was $8.4 million and $26.5 million for the three months
and year ended December 31, 2014, respectively, compared to $4.7 million
and $20.6 million for the comparable periods in 2013. 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 $4.5 million and
$13.2 million for the three months and year ended December 31, 2014,
respectively, compared to $0.9 million and $11.0 million for the
comparable periods in 2013. The increase in product sales for the three
months ended December 31, 2014 over the fourth quarter of 2013 was
primarily driven by the launch of OTREXUP™, while the increase for the
full year 2014 was driven by the launch of OTREXUP™, offset by a
reduction in VIBEX® epinephrine pens sold to Teva in 2013.

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 $2.3 million and $7.2
million for the three months and year ended December 31, 2014,
respectively, compared to $1.5 million and $4.1 million for the
comparable periods in 2013.

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
$0.9 million and $3.7 million for the three months and year ended
December 31, 2014, respectively, compared to $0.6 million and $0.8
million for the comparable periods in 2013. The increase in the full
year 2014 licensing revenue is primarily related to recognition of
deferred revenue in connection with our promotion and license agreement
with LEO Pharma, Inc. for promotion of OTREXUP™ for the psoriasis
indication.

Royalty revenue is recognized primarily from the in-market sales of
products sold by our partners. Royalty revenue was $0.7 million and $2.4
million for the three months and year ended December 31, 2014,
respectively, compared to $1.7 million and $4.7 million for the
comparable periods in 2013. The decrease in royalties is primarily due
to the decision made by Teva in April 2014 to recall the drug product,
Tev-Tropin® (not the device supplied by the Company) and
hence temporarily eliminate all revenues related to Tev-Tropin®
in the U.S. for the balance of the year.

Total gross profit decreased in the fourth quarter of 2014 to $3.0
million compared to $4.1 million in 2013 and increased for the year to
$15.3 million in 2014 compared to $11.4 million in 2013. The Company
recognized a non-cash expense of $2.2 million in the fourth quarter of
2014 and $3.6 million in the full year 2014 related to excess and
obsolete inventory of OTREXUP™ produced in previous years in preparation
for the launch.

Total operating expenses were approximately $13.0 million and $10.0
million for the fourth quarters of 2014 and 2013, respectively, and
approximately $50.4 million and $32.3 million for the years ended
December 31, 2014 and 2013, respectively. The increases in operating
expenses were driven by costs associated with the launch of OTREXUP™,
higher spend on litigation with Medac Pharma, Inc. and higher research
and development expense primarily related to QS T.

Net loss was approximately $10.1 million and $5.6 million for the fourth
quarters of 2014 and 2013, respectively, and $35.2 million and $20.5
million for the years ended December 31, 2014 and 2013. Net loss per
share was $0.27 and $0.16 for the years ended December 31, 2014 and
2013, respectively. Net loss per share was $0.08 and $0.04 for the
fourth quarters of 2014 and 2013, respectively.

At December 31, 2014, cash and investments totalled approximately $40.0
million compared to approximately $69.1 million at December 31, 2013.

Conference Call, Call Replay and Webcast

Antares Executives will provide a Company update and review 2014
operating results via webcast and conference call on Thursday, March 12,
2015, 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
1-719-325-2455 (International). Callers should reference the Antares
Pharma conference call or conference identification code 8802999.
Callers can access the slide presentation on the “ATRS Investor
Information” section of the Company’s website under the “Presentations”
tab which is found under the “Reports and Documents” tab. Webcast and
telephone replays of the conference call will be available from 11:30
a.m. ET on Thursday, March 12, 2015 through 11:30 a.m. ET on Friday,
March 27, 2015. To access the replay, callers should dial 1-888-203-1112
(US) or 1-719-457-0820 (International) and enter passcode 8802999.

About Antares Pharma

Antares Pharma focuses on self-administered parenteral pharmaceutical
products. The Company markets OTREXUP™ (methotrexate) injection for
subcutaneous use in the treatment of adults with severe active
rheumatoid arthritis and children with active polyarticular juvenile
idiopathic arthritis. LEO Pharma markets OTREXUP™ to dermatologists for
adults with severe recalcitrant psoriasis. Antares Pharma is also
developing QuickShot® Testosterone for testosterone
replacement therapy, and VIBEX® Sumatriptan for the acute
treatment of migraines. 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 Pharmaceutical Industries, Ltd. that includes VIBEX®
epinephrine, exenatide multi-dose pen, and another undisclosed
multi-dose pen. Our reusable needle-free injector for use with human
growth hormone (hGH) is sold worldwide by Ferring Pharmaceuticals BV.

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, including statements made with respect to
the growth of the Company from a company solely dependent on licensing
and development revenues to a specialty pharmaceutical company
commercializing its own products; the growth of sales of OTREXUP™; the
approval by the U.S. Food and Drug Administration (FDA) of VIBEX
®
Epinephrine Pen, the timing thereof and the therapeutic
equivalence rating therefor; the timing, cost and design, including
number of patients, of the study to provide additional data based on
recommendations from the FDA regarding the clinical development program
for QuickShot
® Testosterone (QS T); FDA action
with respect to ANDA filed for the exenatide pen; FDA action with
respect to VIBEX
® Sumatriptan; product
candidates in development; 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. Such forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties that may
cause actual results to differ materially from those anticipated by the
forward-looking statements. 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, 2014, 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 Year Ended
December 31, Increase December 31, Increase
2014   2013 (Decrease) 2014   2013 (Decrease)
OTREXUP™ $ 2,818 $ - N/A $ 7,310 $ - N/A
Needle-free injector devices and components 813 728 12 % 4,409 3,496 26 %
Auto injector and pen injector devices 840 177 375 % 1,477 6,952

(79

)%

Other product sales   -   - -     -   510

N/A

 
Total product sales 4,471 905 394 % 13,196 10,958 20 %
Development revenue 2,292 1,459 57 % 7,246 4,139 75 %
Licensing revenue 925 642 44 % 3,709 849 337 %
Royalties   714   1,739 (59

)%

  2,351   4,672

(50

)%

Total revenue $ 8,402 $ 4,745 77 % $ 26,502 $ 20,618 29 %
 
 
ANTARES PHARMA, INC.
Table 2 – CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands except per share amounts)
   

For the Three Months Ended

For the Year Ended

December 31,

December 31,
2014   2013 2014   2013
Product sales $ 4,471 $ 905 $ 13,196 $ 10,958
Development revenue 2,292 1,459 7,246 4,139
Licensing revenue 925 642 3,709 849
Royalties   714     1,739     2,351     4,672  
Total Revenue 8,402 4,745 26,502 20,618
 
Cost of revenue   5,423     685     11,237     9,197  
Gross Profit 2,979 4,060 15,265 11,421
 
Research and development 5,735 3,477 18,638 15,263
Selling, general and administrative   7,284     6,530     31,740     17,008  
Total Operating Expenses   13,019     10,007     50,378     32,271  
 
Operating loss (10,040 ) (5,947 ) (35,113 ) (20,850 )
Other income and expenses   (8 )   12     (14 )   43  
Net loss before income taxes (10,048 ) (5,935 ) (35,127 ) (20,807 )
Income tax provision (benefit)   25     (300 )   25     (300 )
Net loss $ (10,073 ) $ (5,635 ) $ (35,152 ) $ (20,507 )
 
Basic and diluted net loss per common share $ (0.08 ) $ (0.04 ) $ (0.27 ) $ (0.16 )
 
Basic and diluted weighted average common shares outstanding

131,694

127,836

130,550

126,897

 
 
ANTARES PHARMA, INC.
Table 3 – CONSOLIDATED CONDENSED BALANCE SHEETS
(amounts in thousands)
 
December 31, December 31,
2014 2013
Assets
Cash and investments $ 40,031 $ 69,090
Accounts receivable 3,510 1,034
Inventory 5,860 6,461
Equipment, molds, furniture and fixtures, net 10,829 6,952
Patent rights 2,885 1,345
Goodwill 1,095 1,095
Other assets   4,563   2,955
Total Assets $ 68,773 $ 88,932
 
Liabilities and Stockholders’ Equity
Accounts payable and accrued expenses $ 15,707 $ 11,832
Deferred revenue 11,870 6,386
Stockholder’s equity   41,196   70,714
Total Liabilities and Stockholders’ Equity $ 68,773 $ 88,932
 

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Antares Pharma Reports Fourth Quarter and Full Year 2014 Operating and Financial Results
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