UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
______________
FORM
10-Q
______________
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934.
For
the quarterly period ended March 31, 2010
Commission
File Number 1-32302
ANTARES PHARMA, INC.
|
|
|
|
A
Delaware Corporation
|
IRS
Employer Identification No.
41-1350192
|
250
Phillips Blvd, Suite 290
Ewing,
New Jersey 08618
(609)
359-3020
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the Registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x
No [ ]
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes
[ ] No [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer [ ]
|
Accelerated
filer [ ]
|
Non
–accelerated filer [ ]
(do
not check if a smaller
reporting
company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes
[ ] No x
The
number of shares outstanding of the registrant’s Common Stock, $.01 par value,
as of May 7, 2010 was 82,962,851.
ANTARES
PHARMA, INC.
INDEX
|
|
|
|
PAGE
|
|
|
|
|
|
PART
I.
|
|
|
FINANCIAL
INFORMATION
|
|
|
|
|
|
|
|
Item
1.
|
|
Financial
Statements
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheets, as of March 31, 2010 (Unaudited) and December 31,
2009
|
3
|
|
|
|
|
|
|
|
|
Consolidated
Statements of Operations (Unaudited) for the three months ended March 31,
2010 and 2009
|
4
|
|
|
|
|
|
|
|
|
Consolidated
Statements of Cash Flows (Unaudited) for the three months ended March 31,
2010 and 2009
|
5
|
|
|
|
|
|
|
|
|
Notes
to Consolidated Financial Statements
|
6
|
|
|
|
|
|
|
Item
2.
|
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
12
|
|
|
|
|
|
|
Item
3.
|
|
Quantitative
and Qualitative Disclosures About Market Risk
|
19
|
|
|
|
|
|
|
Item
4.
|
|
Controls
and Procedures
|
19
|
|
|
|
|
|
|
|
|
|
|
PART
II.
|
|
|
OTHER
INFORMATION
|
|
|
|
|
|
|
|
Item
1A.
|
|
Risk
Factors
|
20
|
|
|
|
|
|
|
Item
6.
|
|
Exhibits
|
20
|
|
|
|
|
|
|
|
|
SIGNATURES
|
21
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|
|
PART
I – FINANCIAL INFORMATION
Item
1. FINANCIAL STATEMENTS
ANTARES
PHARMA, INC.
CONSOLIDATED
BALANCE SHEETS
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
11,545,964
|
|
|
$
|
13,559,088
|
|
Accounts
receivable
|
|
|
1,719,261
|
|
|
|
1,542,272
|
|
Inventories
|
|
|
312,540
|
|
|
|
329,553
|
|
Deferred
costs
|
|
|
848,487
|
|
|
|
963,053
|
|
Prepaid
expenses and other current assets
|
|
|
131,155
|
|
|
|
155,255
|
|
Total
current assets
|
|
|
14,557,407
|
|
|
|
16,549,221
|
|
|
|
|
|
|
|
|
|
|
Equipment,
molds, furniture and fixtures, net
|
|
|
308,288
|
|
|
|
317,310
|
|
Patent
rights, net
|
|
|
730,678
|
|
|
|
742,399
|
|
Goodwill
|
|
|
1,095,355
|
|
|
|
1,095,355
|
|
Deferred
costs
|
|
|
408,250
|
|
|
|
408,250
|
|
Other
assets
|
|
|
30,756
|
|
|
|
30,838
|
|
Total
Assets
|
|
$
|
17,130,734
|
|
|
$
|
19,143,373
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,008,304
|
|
|
$
|
1,882,158
|
|
Accrued
expenses and other liabilities
|
|
|
953,568
|
|
|
|
1,048,619
|
|
Deferred
revenue
|
|
|
4,167,643
|
|
|
|
5,311,516
|
|
Total
current liabilities
|
|
|
7,129,515
|
|
|
|
8,242,293
|
|
|
|
|
|
|
|
|
|
|
Deferred
revenue – long term
|
|
|
1,996,154
|
|
|
|
2,050,550
|
|
Total
liabilities
|
|
|
9,125,669
|
|
|
|
10,292,843
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
Equity:
|
|
|
|
|
|
|
|
|
Preferred
Stock: $0.01 par, authorized 3,000,000 shares, none
outstanding
|
|
|
-
|
|
|
|
-
|
|
Common
Stock: $0.01 par; authorized 150,000,000
shares;
|
|
|
|
|
|
|
|
|
82,392,768
and 81,799,541 issued and outstanding at
|
|
|
|
|
|
|
|
|
March
31, 2010 and December 31, 2009, respectively
|
|
|
823,928
|
|
|
|
817,995
|
|
Additional
paid-in capital
|
|
|
140,353,961
|
|
|
|
139,614,459
|
|
Accumulated
deficit
|
|
|
(132,491,540
|
)
|
|
|
(130,882,597
|
)
|
Accumulated
other comprehensive loss
|
|
|
(681,284
|
)
|
|
|
(699,327
|
)
|
|
|
|
8,005,065
|
|
|
|
8,850,530
|
|
Total
Liabilities and Stockholders’ Equity
|
|
$
|
17,130,734
|
|
|
$
|
19,143,373
|
|
See
accompanying notes to consolidated financial statements.
ANTARES
PHARMA, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
|
|
For
the Three Months Ended March 31,
|
|
|
|
2010
|
|
|
2009
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
|
1,326,052
|
|
|
$
|
823,751
|
|
Development
revenue
|
|
|
805,247
|
|
|
|
746,837
|
|
Licensing
revenue
|
|
|
836,073
|
|
|
|
697,707
|
|
Royalties
|
|
|
396,714
|
|
|
|
96,775
|
|
Total
revenue
|
|
|
3,364,086
|
|
|
|
2,365,070
|
|
|
|
|
|
|
|
|
|
|
Cost
of revenue:
|
|
|
|
|
|
|
|
|
Cost
of product sales
|
|
|
656,460
|
|
|
|
444,116
|
|
Cost
of development revenue
|
|
|
658,519
|
|
|
|
645,054
|
|
Total
cost of revenue
|
|
|
1,314,979
|
|
|
|
1,089,170
|
|
Gross
profit
|
|
|
2,049,107
|
|
|
|
1,275,900
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
2,085,825
|
|
|
|
2,206,759
|
|
Sales,
marketing and business development
|
|
|
330,521
|
|
|
|
335,517
|
|
General
and administrative
|
|
|
1,217,632
|
|
|
|
1,312,014
|
|
|
|
|
3,633,978
|
|
|
|
3,854,290
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(1,584,871
|
)
|
|
|
(2,578,390
|
)
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,190
|
|
|
|
18,637
|
|
Interest
expense
|
|
|
(1,296
|
)
|
|
|
(195,233
|
)
|
Foreign
exchange losses
|
|
|
(25,310
|
)
|
|
|
(6,952
|
)
|
Other,
net
|
|
|
1,344
|
|
|
|
(13,417
|
)
|
|
|
|
(24,072
|
)
|
|
|
(196,965
|
)
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(1,608,943
|
)
|
|
$
|
(2,775,355
|
)
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per common share
|
|
$
|
(0.02
|
)
|
|
$
|
(0.04
|
)
|
|
|
|
|
|
|
|
|
|
Basic
and diluted weighted average common shares outstanding
|
|
|
82,265,477
|
|
|
|
68,049,666
|
|
See
accompanying notes to consolidated financial statements.
ANTARES
PHARMA, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
|
|
For
the Three Months Ended March 31,
|
|
|
|
2010
|
|
|
2009
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(1,608,943
|
)
|
|
$
|
(2,775,355
|
)
|
Adjustments
to reconcile net loss to net cash used in
operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
44,238
|
|
|
|
56,884
|
|
Stock-based
compensation expense
|
|
|
332,617
|
|
|
|
262,772
|
|
Amortization
of debt discount and issuance costs
|
|
|
-
|
|
|
|
51,705
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(202,438
|
)
|
|
|
561,977
|
|
Inventories
|
|
|
17,013
|
|
|
|
4,840
|
|
Prepaid
expenses and other current assets
|
|
|
21,224
|
|
|
|
(32,905
|
)
|
Deferred
costs
|
|
|
114,566
|
|
|
|
342,229
|
|
Other
assets
|
|
|
(7
|
)
|
|
|
(16
|
)
|
Accounts
payable
|
|
|
140,963
|
|
|
|
507,918
|
|
Accrued
expenses and other current liabilities
|
|
|
(90,666
|
)
|
|
|
(236,456
|
)
|
Deferred
revenue
|
|
|
(1,151,766
|
)
|
|
|
(996,732
|
)
|
Net
cash used in operating activities
|
|
|
(2,383,199
|
)
|
|
|
(2,253,139
|
)
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases
of equipment, molds, furniture and fixtures
|
|
|
(11,277
|
)
|
|
|
(1,081
|
)
|
Additions
to patent rights
|
|
|
(22,743
|
)
|
|
|
(30,533
|
)
|
Net
cash used in investing activities
|
|
|
(34,020
|
)
|
|
|
(31,614
|
)
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds
from exercise of stock options and warrants
|
|
|
412,817
|
|
|
|
-
|
|
Principal
payments on long-term debt
|
|
|
-
|
|
|
|
(620,497
|
)
|
Net
cash provided by (used in) financing activities
|
|
|
412,817
|
|
|
|
(620,497
|
)
|
|
|
|
|
|
|
|
|
|
Effect
of exchange rate changes on cash and cash equivalents
|
|
|
(8,722
|
)
|
|
|
(15,727
|
)
|
|
|
|
|
|
|
|
|
|
Net
decrease in cash and cash equivalents
|
|
|
(2,013,124
|
)
|
|
|
(2,920,977
|
)
|
Cash
and cash equivalents:
|
|
|
|
|
|
|
|
|
Beginning
of period
|
|
|
13,559,088
|
|
|
|
13,096,298
|
|
End
of period
|
|
$
|
11,545,964
|
|
|
$
|
10,175,321
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes to consolidated financial statements
ANTARES PHARMA, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
1.
Description of Business
Antares
Pharma, Inc. (the “Company” or “Antares”) is an emerging pharma company that
focuses on self-injection pharmaceutical products and technologies and topical
gel-based products. The Company's injection technology platforms include Vibex™
disposable pressure-assisted auto injectors, Vision™ reusable needle-free
injectors, and disposable multi-use pen injectors. Pharmaceutical and
biotechnology companies are viewed as the Company's primary
customers.
In the
injector area, the Company has licensed its reusable needle-free injection
device for use with human growth hormone (“hGH”) to Teva Pharmaceutical
Industries, Ltd. (“Teva”), Ferring Pharmaceuticals BV (“Ferring”) and JCR
Pharmaceuticals Co., Ltd. (“JCR”). In August 2009, the Company announced
that Teva launched its Tjet®
injector system, which uses the Company’s needle-free device to administer
Teva’s Tev-Tropin® brand
hGH. The Company has also licensed both disposable auto and pen
injection devices to Teva for use in certain fields and
territories. In 2009, the Company received a payment of $4,076,375
from Teva for tooling and for an advance for the design, development and
purchase of additional tooling and automation equipment, all of which is related
to a fixed, single-dose, disposable injector product containing epinephrine
using the Company’s Vibex™ auto injector platform. In addition, the
Company continues to support existing customers of its reusable needle-free
devices for the home or alternate site administration of insulin in the U.S.
market through distributors.
In the
gel-based area, the Company’s lead product candidate, Anturol®, an
oxybutynin ATD™ gel for the treatment of overactive bladder (“OAB”), is
currently under evaluation in a pivotal Phase 3 trial, for which the Company
expects to file a New Drug Application (“NDA”) in 2010. The Company
also has a partnership with BioSante Pharmaceuticals, Inc. (“BioSante”) that
includes LibiGel®
(transdermal testosterone gel) in Phase 3 clinical development for the treatment
of female sexual dysfunction (“FSD”), and Elestrin®
(estradiol gel) currently marketed in the U.S. for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause.
The
Company has operating facilities in the U.S. and Switzerland. The
U.S. operation manufactures and markets the Company’s reusable needle-free
injection devices and related disposables, and develops its disposable
pressure-assisted auto injector and pen injector systems. These operations,
including all development and some U.S. administrative activities, are located
in Minneapolis, Minnesota. The Company’s Pharma division is located
both in the U.S. and in Muttenz, Switzerland, where pharmaceutical products are
developed utilizing the Company’s transdermal systems. The Company’s
corporate offices are located in Ewing, New Jersey.
The
accompanying unaudited consolidated financial statements have been prepared in
accordance with generally accepted accounting principles in the United State of
America for interim financial information and with the instructions to Form 10-Q
and Article 10 of the Securities and Exchange Commission's Regulation
S-X. Accordingly, they do not include all of the information and
footnotes required by accounting principles generally accepted in the
United
States of
America for complete financial statements. In the opinion of
management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been included. The
accompanying consolidated financial statements and notes should be read in
conjunction with the Company’s Annual Report on Form 10-K for the year ended
December 31, 2009. Operating results for the three-month period ended
March 31, 2010 is not necessarily indicative of the results that may be expected
for the year ending December 31, 2010.
3.
Stockholders’ Equity
Common
Stock
|
Stock
option exercises in the first three months of 2010 resulted in proceeds of
$412,817 and in the issuance of 570,500 shares of common
stock.
|
|
Stock
Options and Warrants
|
The
Company records compensation expense associated with share based awards granted
to employees at the fair value of the award on the date of grant. The
expense is recognized over the period during which an employee is required to
provide services in exchange for the award.
The
Company’s 2008 Equity Compensation Plan (the “Plan”) allows for the grants of
options, restricted stock, stock units, stock appreciation rights and/or
performance awards to officers, directors, consultants and
employees. Under the Plan, the maximum number of shares of stock that
may be granted to any one participant during a calendar year is 1,000,000
shares. Options to purchase shares of common stock are granted at
exercise prices not less than 100% of the fair market value on the dates of
grant. The term of the options range from three to eleven years and
they vest in varying periods. As of March 31, 2010, the Plan had
712,399 shares available for grant. The number of shares available
for grant does not take into consideration potential stock awards that could
result in the issuance of shares of common stock if certain performance
conditions are met, discussed under “Stock Awards” below. Stock
option exercises are satisfied through the issuance of new shares.
A summary
of stock option activity under the Plan as of March 31, 2010, and the changes
during the three-month period then ended is as
follows:
|
|
Number
of
Shares
|
|
|
Weighted
Average
Exercise
Price
($)
|
|
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
|
|
Aggregate
Intrinsic
Value
($)
|
|
Outstanding
at December 31, 2009
|
|
|
8,339,684 |
|
|
|
1.13 |
|
|
|
|
|
|
|
Granted
|
|
|
200,000 |
|
|
|
1.30 |
|
|
|
|
|
|
|
Exercised
|
|
|
(570,500 |
) |
|
|
0.72 |
|
|
|
|
|
|
|
Cancelled
|
|
|
(36,200 |
) |
|
|
1.56 |
|
|
|
|
|
|
|
Outstanding
at March 31, 2010
|
|
|
7,932,984 |
|
|
|
1.16 |
|
|
|
6.7 |
|
|
|
2,844,000 |
|
Exercisable
at March 31, 2010
|
|
|
5,679,674 |
|
|
|
1.30 |
|
|
|
5.8 |
|
|
|
1,608,000 |
|
During
the first three months of 2010 and 2009 the Company granted options to purchase
a total of 200,000 and 50,000 shares of its common stock,
respectively. The options were granted at
exercise
prices of $1.30 and $0.48 in 2010 and 2009, respectively, which equaled the fair
value of the Company’s common stock on the dates of the grants.
Total
recognized compensation expense for stock options was approximately $274,000 and
$243,000 for the first three months of 2010 and 2009,
respectively. As of March 31, 2010, there was approximately $914,000
of total unrecognized compensation cost related to nonvested outstanding stock
options that is expected to be recognized over a weighted average period of
approximately two years.
The per
share weighted average fair value of options granted during the first three
months of 2010 and 2009 were estimated as $0.70 and $0.31 on the date of grant
using the Black-Scholes option pricing model based on the assumptions noted in
the table below. Expected volatilities are based on the historical
volatility of the Company’s stock price. The weighted average
expected life is based on both historical and anticipated employee
behavior.
|
|
March
31,
|
|
|
|
2010
|
|
|
2009
|
|
Risk-free
interest rate
|
|
2.5
|
%
|
|
1.6
|
%
|
Annualized
volatility
|
|
61.0
|
%
|
|
82.0
|
%
|
Weighted
average expected life, in years
|
|
5.0
|
|
|
5.0
|
|
Expected
dividend yield
|
|
0.0
|
%
|
|
0.0
|
%
|
Warrants
to purchase a total of 18,295,409 shares of common stock were outstanding at
March 31, 2010. The weighted average exercise price of the warrants
was $1.56.
The
weighted average exercise price of the stock options and warrants outstanding at
March 31, 2010 and 2009 was $1.44 and $1.58, respectively.
Stock
Awards
The
employment agreements with the Chief Executive Officer, Chief Financial Officer
and other members of executive management include stock-based incentives under
which the executives could be awarded up to approximately 1,530,000 shares of
common stock upon the occurrence of various triggering events. Of
these shares, 22,727 were awarded in the first quarter of 2010 and 180,681 were
awarded prior to 2010. A total of approximately $2,100 of
compensation expense was recorded in the first quarter of 2010 in connection
with awards considered probable of achievement.
A total
of 435,768 shares of common stock have been granted as stock awards to members
of management, of which 170,768 were granted in the first quarter of
2010. The majority of the stock awards vest over a three year period,
although 25,000 shares granted in the first quarter of 2010 vested
immediately. A total of 265,769 of the shares granted are unvested as
of March 31, 2010. Expense is recognized on a straight line basis
over the vesting period and is based on the fair value of the stock on the grant
date. The fair value of each stock award is determined based on the
number of shares granted and the market price of the Company’s common stock on
the date of grant. Expense recognized in connection with these awards
was approximately $52,000 and $12,000 in the first quarters of 2010 and 2009,
respectively. The weighted average fair value of the shares granted
in 2010 was $1.30 per share.
4. Net
Loss Per Share
Basic
loss per common share is computed by dividing net loss applicable to common
stockholders by the weighted-average number of common shares outstanding for the
period. Diluted loss per common share reflects the potential dilution
from the exercise or conversion of securities into common
stock. Potentially dilutive stock options and warrants excluded from
dilutive loss per share because of their effect was anti-dilutive totaled
26,228,393 and 21,060,966 at March 31, 2010 and 2009,
respectively. The table below discloses the basic and diluted loss
per common share.
|
|
Three
Months Ended
March
31,
|
|
|
|
2010
|
|
|
2009
|
|
Net
loss
|
|
$
|
(1,608,943
|
)
|
|
$
|
(2,775,355
|
)
|
Basic
and diluted weighted average common shares outstanding
|
|
|
82,265,477
|
|
|
|
68,049,666
|
|
Basic
and diluted net loss per common share
|
|
$
|
(0.02
|
)
|
|
$
|
(0.04
|
)
|
5. Industry
Segment and Operations by Geographic Areas
The
Company has one operating segment, drug delivery, which includes the development
of drug delivery transdermal products and drug delivery injection devices and
supplies.
The
geographic distributions of the Company’s identifiable assets and revenues are
summarized in the following tables:
The
Company has total assets located in two countries as follows:
|
|
March
31,
2010
|
|
|
December
31,
2009
|
|
Switzerland
|
|
$ |
1,482,814 |
|
|
$ |
1,759,362 |
|
United
States of America
|
|
|
15,647,920 |
|
|
|
17,384,011 |
|
|
|
$ |
17,130,734 |
|
|
$ |
19,143,373 |
|
Revenues
by customer location are summarized as follows:
|
|
For
the Three Months Ended
March
31,
|
|
|
|
2010
|
|
|
2009
|
|
United
States of America
|
|
$ |
1,700,175 |
|
|
$ |
1,123,421 |
|
Europe
|
|
|
1,546,934 |
|
|
|
1,182,735 |
|
Other
|
|
|
116,977 |
|
|
|
58,914 |
|
|
|
$ |
3,364,086 |
|
|
$ |
2,365,070 |
|
|
Significant
customers comprising 10% or more of total revenue are as
follows:
|
|
For
the Three Months Ended
March
31,
|
|
2010
|
|
|
2009
|
Ferring
|
$
|
1,526,937
|
|
|
$
|
824,842
|
Teva
|
|
1,328,038
|
|
|
|
592,316
|
Population
Council
|
|
-
|
|
|
|
393,242
|
Undisclosed
|
|
-
|
|
|
|
338,220
|
6. Comprehensive
Loss
|
|
Three
Months Ended
March
31,
|
|
|
|
2010
|
|
|
2009
|
|
Net
loss
|
|
$
|
(1,608,943
|
)
|
|
$
|
(2,775,355
|
)
|
Change
in cumulative translation adjustment
|
|
|
18,043
|
|
|
|
73,723
|
|
Comprehensive
loss
|
|
$
|
(1,590,900
|
)
|
|
$
|
(2,701,632
|
)
|
7. Revenue
Recognition Change
In the
third quarter of 2009, the Company elected early adoption of Financial
Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2009-13,
“Revenue Arrangements with Multiple Deliverables” (“ASU
2009-13”). ASU 2009-13, which amended FASB ASC 605-25,
“Multiple-Element Arrangements,” is effective for arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010, but
allows for early adoption. ASU 2009-13 requires a vendor to allocate
revenue to each unit of accounting in arrangements involving multiple
deliverables. It changes the level of evidence of standalone selling
price required to separate deliverables by allowing a vendor to make its best
estimate of the standalone selling price of deliverables when vendor specific
objective evidence or third party evidence of selling price is not
available. As a result of adoption of ASU 2009-13, deferred revenues
and deferred costs associated with one License, Development and Supply Agreement
with Teva will be recognized as revenues and expenses earlier than would
otherwise have occurred. Adoption of ASU 2009-13 had no impact on the
accounting for any of the Company’s other revenue arrangements containing
multiple deliverables. Revenues and expenses generated in connection
with future multiple element arrangements will likely often be recognized over
shorter periods than would have occurred prior to adoption of ASU
2009-13.
The
Company elected to adopt ASU 2009-13 on a prospective basis, with retrospective
application to January 1, 2009. Because ASU 2009-13 was adopted in
the third quarter of 2009, the amounts reported in the first and second quarters
of 2009 are required to be adjusted and reported as if adoption occurred on
January 1, 2009.
The table
below reconciles the first quarter 2009 amounts as previously reported to the
amounts as reported in the consolidated statement of operations after applying
adjustments reflecting adoption of ASU 2009-13 on a prospective basis with
retrospective application to January 1, 2009.
|
|
Three
Months Ended March 31, 2009
|
|
|
|
As
Previously
|
|
|
Adoption
|
|
|
As
Reported
|
|
|
|
Reported
|
|
|
Adjustments
|
|
|
After
Adoption
|
|
Development
revenue
|
|
$ |
680,170 |
|
|
$ |
66,667 |
|
|
$ |
746,837 |
|
Licensing
revenue
|
|
|
425,707 |
|
|
|
272,000 |
|
|
|
697,707 |
|
Total
revenue
|
|
|
2,026,403 |
|
|
|
338,667 |
|
|
|
2,365,070 |
|
Cost
of development and licensing revenue
|
|
|
267,739 |
|
|
|
377,315 |
|
|
|
645,054 |
|
Total
cost of revenue
|
|
|
711,855 |
|
|
|
377,315 |
|
|
|
1,089,170 |
|
Gross
profit
|
|
|
1,314,548 |
|
|
|
(38,648 |
) |
|
|
1,275,900 |
|
Operating
loss
|
|
|
(2,539,742 |
) |
|
|
(38,648 |
) |
|
|
(2,578,390 |
) |
Net
loss
|
|
|
(2,736,707 |
) |
|
|
(38,648 |
) |
|
|
(2,775,355 |
) |
Basic
and diluted net loss per common share
|
|
$ |
(0.04 |
) |
|
|
|
|
|
$ |
(0.04 |
) |
8. New
Accounting Pronouncements
In April
2010, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update (ASU) 2010-17 (ASU 2010-17), Revenue
Recognition—Milestone Method (Topic 605), which provides guidance on
defining a milestone and determining when it may be appropriate to apply the
milestone method of revenue recognition for research or development
transactions. Research or development arrangements frequently include payment
provisions whereby a portion or all of the consideration is contingent upon
milestone events such as successful completion of phases in a study or achieving
a specific result from the research or development efforts. The amendments in
this ASU provide guidance on the criteria that should be met for determining
whether the
milestone
method of revenue recognition is
appropriate. ASU 2010-17 is effective for fiscal years and interim periods
within those years beginning on or after June 15, 2010, with early adoption
permitted. This ASU is effective for the Company on January 1,
2011. The Company is currently evaluating the impact, if any,
ASU 2010-17 will have on the Company’s consolidated financial
statements.
Item
2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Forward-Looking
Statements
Management’s
discussion and analysis of the significant changes in the consolidated results
of operations, financial condition and cash flows of the Company is set forth
below. Certain statements in this report may be considered to be
“forward-looking statements” as that term is defined in the U.S. Private
Securities Litigation Reform Act of 1995, such as statements that include the
words “expect,” “estimate,” “project,” “anticipate,” “should,” “intend,”
“probability,” “risk,” “target,” “objective” and other words and terms of
similar meaning in connection with any discussion of, among other things, future
operating or financial performance, strategic initiatives and business
strategies, regulatory or competitive environments, our intellectual property
and product development. In particular, these forward-looking
statements include, among others, statements about:
·
|
the
impact of new accounting
pronouncements;
|
·
|
our
expectations regarding the product development of Anturol®;
|
·
|
our
expectations regarding continued product development with
Teva;
|
·
|
our
plans regarding potential manufacturing and marketing
partners;
|
·
|
our
expectations regarding a net loss for the year ending December 31, 2010;
and
|
·
|
our
ability to raise additional financing, reduce expenses or generate funds
in light of our current and projected level of operations and general
economic conditions.
|
The words
“may,” “will,” “expect,” “intend,” “anticipate,” “estimate,” “believe,”
“continue,” and similar expressions may identify forward-looking statements, but
the absence of these words does not necessarily mean that a statement is not
forward-looking. Forward-looking statements involve known and unknown
risks, uncertainties and achievements, and other factors that may cause our or
our industry’s actual results, levels of activity, performance, or achievements
to be materially different from the information expressed or implied by these
forward-looking statements. While we believe that we have a
reasonable basis for each forward-looking statement contained in this report, we
caution you that these statements are based on a combination of facts and
factors currently known by us and projections of the future about which we
cannot be certain. Many factors may affect our ability to achieve our
objectives, including:
·
|
our
inability to compete successfully against new and existing competitors or
to leverage our marketing capabilities and our research and development
capabilities;
|
·
|
delays
in product introduction and marketing or interruptions in
supply;
|
·
|
a
decrease in business from our major customers and
partners;
|
·
|
adverse
economic and political conditions;
|
·
|
our
inability to obtain additional financing, reduce expenses or generate
funds when necessary;
|
·
|
our
inability to attract and retain key personnel;
and
|
·
|
our
inability to effectively market our services or obtain and maintain
arrangements with our customers, partners and
manufacturers.
|
In
addition, you should refer to the “Risk Factors” section of our Annual Report on
Form 10-K for the year ended December 31, 2009 for a discussion of other factors
that may cause our actual results to differ materially from those described by
our forward-looking statements. As a result of these factors, we
cannot assure you that the forward-looking statements contained in this report
will prove to be accurate and, if our forward-looking statements prove to be
inaccurate, the inaccuracy may be material.
We
encourage readers of this report to understand forward-looking statements to be
strategic objectives rather than absolute targets of future
performance. Forward-looking statements speak only as of the date
they are made. We do not intend to update publicly any
forward-looking statements to reflect circumstances or events that occur after
the date the forward-looking statements are made or to reflect the occurrence of
unanticipated events except as required by law. In light of the
significant uncertainties in these forward-looking statements, you should not
regard these statements as a representation or warranty by us or any other
person that we will achieve our objectives and plans in any specified time
frame, if at all.
The
following discussion and analysis, the purpose of which is to provide investors
and others with information that we believe to be necessary for an understanding
of our financial condition, changes in financial condition and results of
operations, should be read in conjunction with the financial statements, notes
and other information contained in this report.
Antares
Pharma, Inc. is an emerging pharma company that focuses on self-injection
pharmaceutical products and technologies and topical gel-based products.
Our injection technology platforms include Vibex™ disposable pressure-assisted
auto injectors, Vision™ reusable needle-free injectors, and disposable multi-use
pen injectors. We currently view pharmaceutical and biotechnology
companies as our primary customers.
In the
injector area, we have licensed our reusable needle-free injection device for
use with hGH to Teva, Ferring and JCR. In August 2009, we announced that
Teva launched its Tjet®
injector system, which uses our needle-free device to administer Teva’s
Tev-Tropin® brand
hGH. We have also licensed both disposable auto and pen injection
devices to Teva for use in certain fields and territories. In 2009,
we received a payment of $4,076,375 from Teva for tooling and for an advance for
the design, development and purchase of additional tooling and automation
equipment, all of which is related to a fixed, single-dose, disposable injector
product containing epinephrine using our Vibex™ auto injector
platform. In addition, we continue to support existing customers of
our reusable needle-free devices for the home or alternate site administration
of insulin in the U.S. market through distributors.
In the
gel-based area, our lead product candidate, Anturol®, an
oxybutynin ATD™ gel for the treatment of OAB, is currently under evaluation in a
pivotal Phase 3 trial, for which we expect to file an NDA in
2010. Spending on this program in the first quarter of 2010 was
approximately $1,300,000, and we expect spending in 2010 to be approximately
$5,000,000. We also have a partnership with BioSante that
includes
LibiGel®
(transdermal testosterone gel) in Phase 3 clinical development for the treatment
of FSD, and Elestrin®
(estradiol gel) currently marketed in the U.S for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause.
We have
operating facilities in the U.S. and Switzerland. Our U.S. operation
manufactures and markets our reusable needle-free injection devices and related
disposables, and develops our disposable pressure-assisted auto injector and pen
injector systems. These operations, including all development and some U.S.
administrative activities, are located in Minneapolis, Minnesota. Our
Pharma division is located both in the U.S. and in Muttenz, Switzerland, where
pharmaceutical products are developed utilizing our transdermal
systems. Our corporate offices are located in Ewing, New
Jersey.
We
incurred a net loss of $1,608,943 for the three-month period ended March 31,
2010 and we expect to report a net loss for the year ending December 31,
2010. We have not historically generated sufficient revenue to
provide the cash needed to support our operations, and have continued
to operate primarily by raising capital and incurring debt. In order
to better position ourselves to take advantage of potential growth opportunities
and to fund future operations, during 2009 we raised additional capital and took
steps to reduce our monthly cash obligations. We believe that the
combination of our current cash and cash equivalents balance, our recent
reductions in our monthly cash outflows, our projected product sales, product
development revenue, license revenues, milestone payments and royalties will
provide us with sufficient funds to support operations for at least the next 12
months.
Results
of Operations
Three
Months Ended March 31, 2010 and 2009
Revenues
Total
revenue for the three months ended March 31, 2010 increased to $3,364,086 from
$2,365,070 in the same period of the prior year. Product revenue
increased to $1,326,052 in the first quarter of 2010 from $823,751 in the first
quarter of 2009 primarily due to sales of Tjet®
needle-free injector devices and disposable components to Teva following Teva’s
August 2009 launch of our needle-free device with their hGH Tev-Tropin®,
along with an increase in sales to Ferring. Development revenue
increased to $805,247 in the first quarter of 2010 from $746,837 in the first
quarter of 2009 primarily due to auto injector development work under a 2009
amendment to a License, Development and Supply Agreement with Teva that
originated in 2006. The 2010 development revenue is primarily
recognition of a portion of the payment received under the amendment in 2009 of
$4,076,375, all of which was originally deferred. Licensing revenue
increased in the first quarter of 2010 to $836,073 from $697,707 in the prior
year, primarily due to recognition of revenue deferred in 2009 under an
Exclusive License Agreement with Ferring, in addition to milestone payments
received in connection with an existing License Agreement with
BioSante. Royalty revenue increased in the first quarter to $396,714
in 2010 from $96,775 in 2009 primarily due to royalties received from Teva in
connection with sales of their hGH Tev-Tropin®.
Cost
of Revenues and Gross Margins
The cost
of product sales are related to our reusable needle free injector devices and
disposable components. For the three-month period ended March 31,
2010, cost of product sales was $656,460 compared to $444,116 for the same
period of the prior year. Gross margins were 50% and 46% in
three-month periods ended March 31, 2010 and 2009, respectively. The
gross margin increase was primarily
due to a
higher volume of product sales absorbing a relatively unchanged level of fixed
overhead expenses.
The cost
of development revenue consists primarily of direct external costs, some of
which may have been previously incurred and deferred, along with labor costs and
an allocation of certain overhead expenses based on actual costs and time spent
related to revenue generating development arrangements. Cost of development
revenue was $658,519 and $645,054 for the first quarters of 2010 and 2009,
respectively. The increase in 2010 compared to 2009 was primarily due
to an increase in development costs recognized related to a License, Development
and Supply Agreement with Teva for a product utilizing our auto injector
technology.
Research
and Development
The
majority of research and development expenses consist of external costs for
studies and analysis activities, design work and prototype
development. While we are typically engaged in research and
development activities involving each of our drug delivery programs, over 75% of
our total research and development expenses in each year were generated in
connection with projects related to transdermal gel products, primarily
Anturol®. Research
and development expenses were $2,085,825 and $2,206,759 in the three-month
periods ended March 31, 2010 and 2009, respectively. The decrease in
the first quarter of 2010 compared to the prior year was due primarily to a
slight decrease in expenses related to the Phase III study of Anturol®. Expenses
incurred related to research and development activities in Switzerland decreased
in the first quarter of 2010 compared to 2009 as a result of the transaction
with Ferring at the end of 2009. However, there was minimal change in
the amount of reported research and development expenses in 2010
compared to 2009 because a portion of the expenses incurred in the first quarter
of 2009 were directly related to development revenue and were therefore recorded
as cost of development revenue, reducing the amount recorded as research and
development expense.
Sales,
Marketing and Business Development
Sales,
marketing and business development expenses totaled $330,521 and $335,517 for
the three-month periods ended March 31, 2010 and 2009,
respectively. Decreases in expenses in 2010 compared to 2009 related
to the operations in Switzerland and decreases in consulting fees were offset by
increases in payroll and travel expenses due to the addition of a senior level
business development employee in January of this year.
General
and Administrative
General
and administrative expenses totaled $1,217,632 and $1,312,014 in the three-month
periods ended March 31, 2010 and 2009, respectively. General and
administrative expenses associated with the operations in Switzerland decreased
significantly as a result of the transaction with Ferring at the end of
2009. These decreases were partially offset by increases in noncash
stock compensation expenses and other payroll expenses.
Other
Income (Expense)
Other
expense was $24,072 and $196,965 in the three-month periods ended March 31, 2010
and 2009, respectively. The decrease in expense resulted primarily from a
decrease in interest expense of $193,937 due to the retirement of our credit
facility in the third quarter of 2009.
Liquidity
and Capital Resources
We have
not historically generated sufficient revenue to provide the cash needed to
support our operations, and we have continued to operate primarily by raising
capital and incurring debt. In order to better position ourselves to
take advantage of potential growth opportunities and to fund future operations,
during 2009 we raised additional capital and took steps to reduce our monthly
cash obligations.
In July
2009, we raised gross proceeds of $8,500,000 in a registered direct offering
through the sale of shares of our common stock and warrants. We sold
a total of 10,625,000 units, each unit consisting of (i) one share of common
stock and (ii) one warrant to purchase 0.4 of a share of common stock (or a
total of 4,250,000 shares), at a purchase price of $0.80 per
unit. The warrants will be exercisable six months after issuance at
$1.00 per share and will expire five years from the date of
issuance.
In
September 2009, we raised gross proceeds of $3,000,000 through the sale of
2,727,273 units to certain institutional investors, each unit consisting of (i)
one share of common stock and (ii) one warrant to purchase 0.4 of a share of
common stock (or a total of 1,090,909 shares), at a purchase price of $1.10 per
unit. The warrants will be exercisable six months after issuance at $1.15 per
share and will expire five years from the date of issuance.
The
proceeds from the sale of common stock and warrants in September 2009 were used
to pay off the remaining balance of our credit facility, reducing our monthly
debt service requirements. The credit facility had originated in
2007, when we received gross proceeds of $7,500,000 in two tranches of
$5,000,000 and $2,500,000 to help fund working capital needs. The per
annum interest rate was 12.7% in the case of the first tranche and 11% in the
case of the second tranche. The maturity date (i) with respect to the
first tranche was forty-two months from February 2007 and (ii) with respect to
the second tranche was thirty-six months from December 2007.
In the
fourth quarter of 2009, we reduced our monthly overhead when we entered into an
Asset Purchase Agreement with Ferring. Under this agreement, Ferring assumed
responsibility for all of our facility and equipment lease obligations in
connection with our operations in Switzerland, and the majority of our employees
at that location were hired by Ferring effective January 1,
2010. Subsequent to the Ferring agreement we entered into a
month-to-month office lease agreement at a new Swiss location in a much smaller
space at a significantly reduced monthly rate.
In the
first quarter of 2010, we received proceeds of $412,817 in connection with
exercises of options to purchase shares of our common stock, which resulted in
the issuance of 570,500 shares of our common stock.
At March
31, 2010, we had cash and cash equivalents of $11,545,964. We believe
that the combination of our current cash and cash equivalents balance and
projected product sales, product development, license revenues, milestone
payments and royalties will provide us with sufficient funds to support
operations for at least the next 12 months. We do not currently have
any bank credit lines. In the future, if we need additional financing
and are unable to obtain such financing when needed, or obtain it on favorable
terms, we may be required to curtail development of new products, limit
expansion of operations or accept financing terms that are not as attractive as
we may desire.
Cash
Flows
Net Cash Used in Operating
Activities
Net cash
used in operating activities was $2,383,199 and $2,253,139 for the three-month
periods ended March 31, 2010 and 2009, respectively. The decrease in
the loss of $1,166,412 to $1,608,943 for the first quarter of 2010 from
$2,772,355 for the first quarter of 2009 was offset by significant differences
in changes in operating assets and liabilities, particularly accounts receivable
and accounts payable.
Net Cash Provided by (Used in)
Investing Activities
Net cash
used in investing activities was $34,020 in the first three months of 2010
compared to $31,614 in the first three months of 2009. Cash used for
purchases of equipment, molds, furniture and fixtures was $11,277 in 2010
compared to $1,081 in 2009 and additions to patent rights was $22,743 in 2010
compared to $30,533 in 2009.
Net Cash Provided by (Used in)
Financing Activities
Net cash
provided by financing activities in the first three months of 2010 was $412,817
from the exercise of stock options and net cash used in financing activities in
the first three months of 2009 was $620,497 due to principal payments on
long-term debt.
Research
and Development Programs
Our
current research and development activities are primarily related to
Anturol® and
device development projects.
Anturol®. We
are currently evaluating Anturol® for
the treatment of OAB. In the fourth quarter of 2007 we initiated a
Phase III pivotal trial designed to evaluate the efficacy of
Anturol® when
administered topically once daily for 12 weeks in patients predominantly with
urge incontinence episodes. The randomized, double-blind, parallel,
placebo-controlled, multi-center trial is expected to involve 600 patients (200
per arm) using two dose strengths (selected from the Phase II clinical trial)
versus a placebo. Enrollment expanded to approximately sixty centers throughout
the United States in 2009. In addition to the Phase III trial, we
have incurred significant costs related to Anturol®
manufacturing development. We have contracted with Patheon, Inc.
(“Patheon”), a manufacturing development company, to supply clinical quantities
of Anturol® and
to develop a commercial manufacturing process for Anturol®. With
Patheon, we have completed limited commercial scale up activities associated
with Anturol®
manufacturing. As of March 31, 2010, we have incurred total external
costs of approximately $14,200,000 in connection with our Anturol®
research and development, of which approximately $1,300,000 was incurred in the
first quarter of 2010. We intend to seek a marketing partner to help
fund the development of Anturol® and
to commercially launch Anturol® if
approved by the U.S. Food and Drug Administration. To date, we have
not entered into an agreement with a marketing partner. However, in
the third quarter of 2009, we raised gross proceeds of $11,500,000 through the
sale of shares of our common stock and warrants. Because of the
additional funding received, we are continuing the Anturol®
development program and expect total expenses for Anturol® to be
approximately $5,000,000 in 2010. Although the Phase III program for
Anturol® is
continuing, the rate of progress of the program will be determined by the level
of expenditures, which may be affected by the timing of engaging a marketing
partner.
Device Development
Projects. We are engaged in research and development
activities related to our Vibex™ disposable pressure-assisted auto injectors and
our disposable pen injectors. We have signed license agreements with
Teva for our Vibex™ system for use with epinephrine and an undisclosed product
and for our pen injector device for two undisclosed products. Our
pressure-assisted auto injectors are designed to deliver drugs by injection from
single-dose prefilled syringes. The auto injectors are in the
advanced commercial stage of development. The disposable pen injector
device is designed to deliver drugs by injection through needles from multi-dose
cartridges. The disposable pen is in the early stage of development
where devices are being evaluated in clinical studies. Our
development programs consist of determination of the device design, development
of prototype tooling, production of prototype devices for testing and clinical
studies, performance of clinical studies, and development of commercial tooling
and assembly. As of March 31, 2010, we have incurred total external
costs of approximately $5,000,000 in connection with research and development
activities associated with our auto and pen injectors, of which approximately
$600,000 was incurred in the first quarter of 2010. As of March 31,
2010, approximately $3,700,000 of the total costs of $5,000,000 had been
deferred, of which approximately $2,400,000 has been recognized as cost of sales
and $1,300,000 remains deferred. This remaining deferred balance will
be recognized as cost of sales over the same period as the related deferred
revenue will be recognized. The development timelines of the auto and
pen injectors related to the Teva products are controlled by Teva. We
expect development related to the Teva products to continue in 2010, but the
timing and extent of near-term future development will be dependent on certain
decisions made by Teva. In 2009, we received a payment from Teva in
the amount of $4,076,375 in connection with an amendment to a License,
Development and Supply Agreement signed in July 2006 related to a fixed,
single-dose, disposable injector product containing epinephrine using our Vibex™
auto injector platform. Although this payment and certain upfront and milestone
payments have been received from Teva, there have been no commercial sales from
the auto injector or pen injector programs, timelines have been extended and
there can be no assurance that there ever will be commercial sales or future
milestone payments under these agreements.
Other research and development
costs. In addition to the Anturol®
project and Teva related device development projects, we incur direct costs in
connection with other research and development projects related to our
technologies and indirect costs that include salaries, administrative and other
overhead costs of managing our research and development
projects. Total other research and development costs were
approximately $700,000 for the quarter ended March 31, 2010.
Off-Balance
Sheet Arrangements
We do not
have any off-balance sheet arrangements, including any arrangements with any
structured finance, special purpose or variable interest entities.
Critical
Accounting Policies
We have
identified certain of our significant accounting policies that we consider
particularly important to the portrayal of our results of operations and
financial position and which may require the application of a higher level of
judgment by management and, as a result, are subject to an inherent level of
uncertainty. These policies are characterized as “critical accounting
policies” and address revenue recognition and valuation of long-lived and
intangible assets and goodwill, as more fully described under “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” in our
Annual Report on Form 10-K for the year ended December 31, 2009. We
have made no changes to these policies during the three-month period ended March
31, 2010.
Item
3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
Our
primary market risk exposure is foreign exchange rate fluctuations of the Swiss
Franc to the U.S. dollar as the financial position and operating results of our
subsidiaries in Switzerland are translated into U.S. dollars for consolidation.
Our exposure to foreign exchange rate fluctuations also arises from transferring
funds to our Swiss subsidiaries in Swiss Francs. In addition, we have exposure
to exchange rate fluctuations between the Euro and the U.S. dollar in connection
with the licensing agreement entered into in January 2003 with Ferring, which
established pricing in Euros for products sold under the supply agreement and
for all royalties. In March 2007, we amended the 2003 agreement with
Ferring, establishing prices in U.S. dollars rather than Euros for certain
products, reducing the exchange rate risk. Most of our sales and
licensing fees are denominated in U.S. dollars, thereby significantly mitigating
the risk of exchange rate fluctuations on trade receivables. We do not currently
use derivative financial instruments to hedge against exchange rate risk.
Because exposure increases as intercompany balances grow, we will continue to
evaluate the need to initiate hedging programs to mitigate the impact of foreign
exchange rate fluctuations on intercompany balances. The effect of
foreign exchange rate fluctuations on our financial results for the three-month
period ended March 31, 2010 was not material.
Item
4.
|
CONTROLS
AND PROCEDURES
|
Disclosure
Controls and Procedures
The
Company’s management, with the participation of the Company’s Chief Executive
Officer and Chief Financial Officer, has evaluated the effectiveness of the
Company’s disclosure controls and procedures (as such term is defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended)
as of the end of the period covered by this report. Based on such
evaluation, the Company’s Chief Executive Officer and Chief Financial Officer
have concluded that the Company’s disclosure controls and procedures as of the
end of the period covered by this report have been designed and are functioning
effectively to provide reasonable assurance that the information required to be
disclosed by the Company in reports filed under the Securities Exchange Act of
1934, as amended, is recorded, processed, summarized and reported within the
time periods specified in the Securities and Exchange Commission’s rules and is
accumulated and communicated to management, including the Company’s principal
executive and principal financial officers, or persons performing similar
functions, as appropriate to allow timely decisions regarding required
disclosure.
Internal
Control over Financial Reporting
There
have not been any changes in the Company’s internal control over financial
reporting during the fiscal quarter to which this report relates that have
materially affected, or are reasonably likely to materially affect, the
Company’s internal control over financial reporting.
A control
system, no matter how well conceived and operated, can provide only reasonable,
not absolute, assurance that the objectives of the control system are met.
Because of the inherent limitations in all control systems, no evaluation of
controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the Company have been detected. The design of
any system of controls is also based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future conditions;
over time, control may become inadequate because of changes in conditions, or
the degree of compliance with the policies or procedures may
deteriorate. Because of the inherent limitations in a cost-effective
control system, misstatements due to error or fraud may occur and not be
detected.
PART
II - OTHER INFORMATION
Item
1A.
|
RISK
FACTORS.
|
|
|
|
|
|
In
addition to the other information contained in this report, you should
carefully consider the risk factors discussed in Part I, “Item
1A. Risk Factors” in our Annual Report on Form 10-K for the
year ended December 31, 2009, which could materially affect our business,
financial condition or future results. The risks described in
our Annual Report on Form 10-K are not the only risks facing
us. Additional risks and uncertainties not currently known to
us or that we currently deem to be immaterial also may materially
adversely affect our business, financial condition and/or operating
results.
|
|
Item
6.
|
EXHIBITS.
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|
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(a)
|
Exhibit
Index
|
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Exhibit No.
|
Description
|
|
|
31.1
|
Certificate
of the Chief Executive Officer of Antares Pharma, Inc. required by
Rule 13a-14(a) under the Securities Exchange Act of 1934, as
amended.
|
|
|
|
|
|
|
31.2
|
Certificate
of the Chief Financial Officer of Antares Pharma, Inc. required by
Rule 13a-14(a) under the Securities Exchange Act of 1934, as
amended.
|
|
|
|
|
|
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32.1
|
Certificate
of the Chief Executive Officer of Antares Pharma, Inc. required by
Rule 13a-14(b) under the Securities Exchange Act of 1934, as
amended.
|
|
|
|
|
|
|
32.2
|
Certificate
of the Chief Financial Officer of Antares Pharma, Inc. required by
Rule 13a-14(b) under the Securities Exchange Act of 1934, as
amended.
|
|
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 thereunto
duly authorized.
|
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ANTARES
PHARMA, INC.
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May
13,2010
|
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/s/
Paul K. Wotton
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Dr.
Paul K. Wotton
|
|
|
President
and Chief Executive Officer
|
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|
|
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/s/
Robert F. Apple
|
|
|
Robert
F. Apple
|
|
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Executive
Vice President and Chief Financial Officer
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21