For the quarterly period ended September 30, 2011
|
A Delaware Corporation | IRS Employer Identification No. 41-1350192 |
Large accelerated filer o | Accelerated filer x | Non –accelerated filer o | Smaller reporting company o |
(do not check if a smaller | |||
reporting company) |
PAGE
|
||||
PART I.
|
FINANCIAL INFORMATION
|
|||
Item 1.
|
Financial Statements
|
|||
3
|
||||
4
|
||||
5
|
||||
6
|
||||
Item 2.
|
12
|
|||
Item 3.
|
19
|
|||
Item 4.
|
19
|
|||
PART II.
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||||
Item 1A.
|
21
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|||
Item 6.
|
21
|
|||
22
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||||
September 30,
|
December 31,
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||||||
2011
|
2010
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||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current Assets:
|
|||||||
Cash and cash equivalents
|
$
|
17,118,832
|
$
|
9,847,813
|
|||
Short-term investments
|
8,996,150
|
-
|
|||||
Accounts receivable, net
|
1,986,786
|
1,245,560
|
|||||
Inventories, net
|
351,494
|
272,463
|
|||||
Deferred costs
|
1,197,331
|
915,689
|
|||||
Prepaid expenses and other current assets
|
255,027
|
193,985
|
|||||
Total current assets
|
29,905,620
|
12,475,510
|
|||||
Long-term investments
|
6,047,665
|
-
|
|||||
Equipment, molds, furniture and fixtures, net
|
494,075
|
327,535
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|||||
Patent rights, net
|
921,563
|
803,426
|
|||||
Goodwill
|
1,095,355
|
1,095,355
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|||||
Deferred costs
|
-
|
408,250
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|||||
Other assets
|
31,424
|
31,226
|
|||||
Total Assets
|
$
|
38,495,702
|
$
|
15,141,302
|
|||
Liabilities and Stockholders’ Equity
|
|||||||
Current Liabilities:
|
|||||||
Accounts payable
|
$
|
1,829,387
|
$
|
1,773,259
|
|||
Accrued expenses and other liabilities
|
1,652,957
|
1,818,769
|
|||||
Deferred revenue
|
3,278,789
|
3,080,062
|
|||||
Total current liabilities
|
6,761,133
|
6,672,090
|
|||||
Deferred revenue – long term
|
839,795
|
1,842,594
|
|||||
Total liabilities
|
7,600,928
|
8,514,684
|
|||||
Stockholders’ Equity:
|
|||||||
Preferred Stock: $0.01 par, authorized 3,000,000 shares, none outstanding
|
-
|
-
|
|||||
Common Stock: $0.01 par; authorized 150,000,000 shares;
|
|||||||
103,509,310 and 84,157,865 issued and outstanding at
|
|||||||
September 30, 2011 and December 31, 2010, respectively
|
1,035,093
|
841,579
|
|||||
Additional paid-in capital
|
171,634,372
|
143,318,671
|
|||||
Accumulated deficit
|
(141,207,784
|
)
|
(136,973,795
|
)
|
|||
Accumulated other comprehensive loss
|
(566,907
|
)
|
(559,837
|
)
|
|||
30,894,774
|
6,626,618
|
||||||
Total Liabilities and Stockholders’ Equity
|
$
|
38,495,702
|
$
|
15,141,302
|
For the Three Months Ended
September 30,
|
For the Nine Months Ended
September 30,
|
||||||||||||||||||
2011
|
2010
|
2011
|
2010
|
||||||||||||||||
Revenue:
|
|||||||||||||||||||
Product sales
|
$
|
2,197,029
|
$
|
1,654,215
|
$
|
5,820,691
|
$
|
4,132,245
|
|||||||||||
Development revenue
|
952,557
|
401,723
|
2,725,275
|
1,704,165
|
|||||||||||||||
Licensing revenue
|
123,419
|
582,817
|
608,445
|
2,462,735
|
|||||||||||||||
Royalties
|
646,032
|
483,305
|
1,877,046
|
1,237,988
|
|||||||||||||||
Total revenue
|
3,919,037
|
3,122,060
|
11,031,457
|
9,537,133
|
|||||||||||||||
Cost of revenue:
|
|||||||||||||||||||
Cost of product sales
|
1,028,376
|
798,532
|
2,741,783
|
2,047,357
|
|||||||||||||||
Cost of development revenue
|
778,674
|
280,982
|
1,911,397
|
1,343,097
|
|||||||||||||||
Total cost of revenue
|
1,807,050
|
1,079,514
|
4,653,180
|
3,390,454
|
|||||||||||||||
Gross profit
|
2,111,987
|
2,042,546
|
6,378,277
|
6,146,679
|
|||||||||||||||
Operating expenses:
|
|||||||||||||||||||
Research and development
|
1,429,210
|
2,332,712
|
5,124,877
|
6,661,325
|
|||||||||||||||
Sales, marketing and business development
|
390,260
|
204,750
|
1,202,127
|
776,549
|
|||||||||||||||
General and administrative
|
1,559,018
|
1,170,041
|
4,325,699
|
3,509,630
|
|||||||||||||||
3,378,488
|
3,707,503
|
10,652,703
|
10,947,504
|
||||||||||||||||
Operating loss
|
(1,266,501
|
)
|
(1,664,957
|
)
|
(4,274,426
|
)
|
(4,800,825
|
)
|
|||||||||||
Other income (expense)
|
(32,758
|
)
|
33,557
|
40,437
|
8,228
|
||||||||||||||
Net loss
|
$
|
(1,299,259
|
)
|
$
|
(1,631,400
|
)
|
$
|
(4,233,989
|
)
|
$
|
(4,792,597
|
)
|
|||||||
Basic and diluted net loss per common share
|
$
|
(0.01
|
)
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.06
|
)
|
|||||||
Basic and diluted weighted average common shares outstanding
|
103,311,772
|
83,615,043
|
94,793,953
|
82,937,306
|
For the Nine Months Ended September 30,
|
||||||
2011
|
2010
|
|||||
Cash flows from operating activities:
|
||||||
Net loss
|
$
|
(4,233,989
|
)
|
$
|
(4,792,597
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||
Depreciation and amortization
|
121,469
|
137,492
|
||||
Gain on sale of equipment, molds, furniture and fixtures
|
(30,000
|
)
|
(14,980
|
)
|
||
Stock-based compensation expense
|
1,488,887
|
889,188
|
||||
Changes in operating assets and liabilities:
|
||||||
Accounts receivable
|
(744,700
|
)
|
626,165
|
|||
Inventories
|
(79,031
|
)
|
42,596
|
|||
Prepaid expenses and other current assets
|
(49,666
|
)
|
68,687
|
|||
Deferred costs
|
126,608
|
348,335
|
||||
Accounts payable
|
55,503
|
(292,715
|
)
|
|||
Accrued expenses and other current liabilities
|
(168,336
|
)
|
173,559
|
|||
Deferred revenue
|
(824,002
|
)
|
(2,511,529
|
)
|
||
Net cash used in operating activities
|
(4,337,257
|
)
|
(5,325,799
|
)
|
||
Cash flows from investing activities:
|
||||||
Purchases of equipment, molds, furniture and fixtures
|
(227,763
|
)
|
(61,621
|
)
|
||
Additions to patent rights
|
(153,650
|
)
|
(82,196
|
)
|
||
Proceeds from sales of equipment, molds, furniture and fixtures
|
30,000
|
14,980
|
||||
Purchases of investment securities |
(15,053,981
|
)
|
-
|
|||
Net cash used in investing activities
|
(15,405,394
|
)
|
(128,837
|
)
|
||
Cash flows from financing activities:
|
||||||
Proceeds from exercise of stock options and warrants
|
5,972,900
|
2,035,480
|
||||
Proceeds from sale of common stock
|
21,280,718
|
-
|
||||
Taxes paid related to net share settlement of equity awards
|
(233,291
|
)
|
-
|
|||
Net cash provided by financing activities
|
27,020,327
|
2,035,480
|
||||
Effect of exchange rate changes on cash and cash equivalents
|
(6,657
|
)
|
87,152
|
|||
Net increase (decrease) in cash and cash equivalents
|
7,271,019
|
(3,332,004
|
)
|
|||
Cash and cash equivalents:
|
||||||
Beginning of period
|
9,847,813
|
13,559,088
|
||||
End of period
|
$
|
17,118,832
|
$
|
10,227,084
|
||
|
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 subcutaneous and intramuscular injection technology platforms include VIBEX™ disposable pressure-assisted auto injectors, Vision™ reusable needle-free injectors, and disposable multi-use pen injectors.
|
|
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”), with Teva and Ferring being the Company’s two primary customers. The Company’s needle-free injection device is used by Teva with the Tjet® injector system to administer their 5mg Tev-Tropin® brand hGH marketed in the U.S. and the Company’s needle-free injection device is used by Ferring with their 4mg and 10mg hGH formulations marketed as Zomajet® 2 Vision and Zomajet® Vision X, respectively, in Europe and Asia. The Company has also licensed both disposable auto and pen injection devices to Teva for use in certain fields and territories and is engaged in product development activities for Teva utilizing these devices. The Company is currently developing commercial tooling and automation equipment for Teva related to a fixed, single-dose, disposable injector product containing epinephrine using the Company’s VIBEX™ auto injector platform. In addition to development of products with partners, in August 2011, the Company announced positive results from a clinical study evaluating its proprietary VIBEX™ MTX methotrexate injection system being developed for the treatment of rheumatoid arthritis. The Company also continues to support existing customers of its reusable needle-free devices for the administration of insulin in the U.S. market through distributors.
|
|
In the gel-based area, the Company received notice from the U.S. Food and Drug Administration (“FDA”) in April 2011 of the FDA’s acceptance for filing for review of a New Drug Application (“NDA”) for Anturol®, an oxybutynin ATD™ gel for the treatment of overactive bladder (“OAB”). The NDA submission was supported by a Phase 3 clinical trial conducted by the Company. In July 2011, the Company entered into a licensing agreement with Watson Pharmaceuticals, Inc. (“Watson”) under which Watson will commercialize Anturol®, once approved. 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 two facilities in the U.S. The Parenteral Products division located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company’s reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted auto injector and pen injector systems. The Company’s Pharma division is located in Ewing, New Jersey, where pharmaceutical products are developed utilizing both the Company’s transdermal systems and drug/device combination products. The Company’s corporate offices are also located in Ewing, New Jersey.
|
2.
|
Basis of Presentation
|
|
The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States 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, 2010. Operating results for the nine months ended September 30, 2011 are not necessarily indicative of the results that may be expected for the year ending December 31, 2011.
|
|
Investments
|
|
All short-term and long-term investments are U.S. Treasury bills or U.S. Treasury notes that are classified as held-to-maturity because the Company has the positive intent and ability to hold the securities to maturity. The securities are carried at their amortized cost. The fair value of all securities is determined by quoted market prices. All long-term investments mature in less than two years. At September 30, 2011 the short-term investments had a fair value of $8,995,140 and a carrying value of $8,996,150 and the long-term investments had a fair value of $6,039,369 and a carrying value of $6,047,665.
|
3.
|
Stockholders' Equity
|
|
Warrant and stock option exercises in the first nine months of 2011 and 2010 resulted in proceeds of $5,972,900 and $2,035,480, respectively, and in the issuance of 4,439,008 and 1,804,884 shares of common stock, respectively.
|
|
Stock Options and Warrants
|
Number of
Shares
|
Weighted
Average
Exercise
Price ($)
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
Aggregate
Intrinsic
Value ($)
|
||||
Outstanding at December 31, 2010
|
7,657,876
|
1.18
|
|||||
Granted
|
971,409
|
1.75
|
|||||
Exercised
|
(713,736
|
)
|
1.37
|
||||
Cancelled
|
(69,550
|
)
|
3.96
|
||||
Outstanding at September 30, 2011
|
7,845,999
|
1.21
|
7.0
|
8,987,230
|
|||
Exercisable at September 30, 2011
|
5,993,359
|
1.12
|
6.4
|
7,456,011
|
September 30,
|
||||
2011
|
2010
|
|||
Risk-free interest rate
|
1.7
|
%
|
2.1
|
%
|
Annualized volatility
|
58.5
|
%
|
61.0
|
%
|
Weighted average expected life, in years
|
5.0
|
5.0
|
||
Expected dividend yield
|
0.0
|
%
|
0.0
|
%
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||
Net loss
|
$
|
(1,299,259
|
)
|
$
|
(1,631,400
|
)
|
$
|
(4,233,989
|
)
|
$
|
(4,792,597
|
)
|
Basic and diluted weighted average common shares outstanding
|
103,311,772
|
83,615,043
|
94,793,953
|
82,937,306
|
||||||||
Basic and diluted net loss per
common share
|
$
|
(0.01
|
)
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.06
|
)
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||
United States of America | $ | 2,525,192 | $ | 1,500,552 | $ | 6,338,645 | $ | 4,746,888 | ||||||
Europe
|
1,292,370
|
|
1,557,820
|
|
4,323,273
|
|
4,513,015
|
|||||||
Other | 101,475 | 63,688 | 369,539 | 277,230 | ||||||||||
|
$
|
3,919,037
|
|
$
|
3,122,060
|
|
$
|
11,031,457
|
|
$
|
9,537,133
|
|
Significant customers comprising 10% or more of total revenue are as follows:
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||
Teva
|
$
|
1,945,134
|
$
|
1,290,478
|
$
|
5,519,202
|
$
|
3,953,783
|
||||||
Ferring
|
1,287,009
|
1,557,819
|
4,321,573
|
4,473,920
|
||||||||||
Watson
|
432,353
|
-
|
432,353
|
-
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
2011
|
2010
|
2011
|
2010
|
||||||||||||
Net loss
|
$
|
(1,299,259
|
)
|
$
|
(1,631,400
|
)
|
$
|
(4,233,989
|
)
|
$
|
(4,792,597
|
)
|
|||
Change in cumulative translation adjustment
|
(33,375
|
)
|
(41,977
|
)
|
(7,070
|
)
|
43,161
|
||||||||
Comprehensive loss
|
$
|
(1,332,634
|
)
|
$
|
(1,673,377
|
)
|
$
|
(4,241,059
|
)
|
$
|
(4,749,436
|
)
|
Item 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
·
|
our expectations regarding the product development and manufacturing of Anturol®;
|
·
|
our expectations regarding continued product development with Teva;
|
·
|
our plans regarding potential manufacturing and marketing partners;
|
·
|
our future cash flow;
|
·
|
our expectations regarding the year ending December 31, 2011;
|
·
|
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; and
|
·
|
the impact of new accounting pronouncements.
|
·
|
delays in product introduction and marketing or interruptions in supply;
|
·
|
a decrease in business from our major customers and partners;
|
·
|
our inability to compete successfully against new and existing competitors or to leverage our marketing capabilities and our research and development capabilities;
|
·
|
our inability to obtain additional financing, reduce expenses or generate funds when necessary;
|
·
|
our inability to attract and retain key personnel;
|
·
|
adverse economic and political conditions; and
|
·
|
our inability to effectively market our services or obtain and maintain arrangements with our customers, partners and manufacturers.
|
Item 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
Item 4.
|
CONTROLS AND PROCEDURES
|
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. | ||
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. | ||
|
SIGNATURES
|
|
ANTARES PHARMA, INC.
|
November 8, 2011
|
/s/ Paul K. Wotton
|
|
Dr. Paul K. Wotton
|
||
President and Chief Executive Officer
|
||
November 8, 2011
|
/s/ Robert F. Apple
|
|
Robert F. Apple
|
||
Executive Vice President and Chief Financial Officer
|
1.
|
I have reviewed this report on Form 10-Q for the fiscal quarter ended September 30, 2011 of Antares Pharma, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:
|
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
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/s/ Paul K. Wotton | |
Dr. Paul K. Wotton | ||
President and Chief Executive Officer | ||
1.
|
I have reviewed this report on Form 10-Q for the fiscal quarter ended September 30, 2011 of Antares Pharma, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:
|
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
/s/ Robert F. Apple | |
Robert F. Apple | |||
Executive Vice President and Chief Financial Officer | |||
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Paul K. Wotton
|
||||
Dr. Paul K. Wotton
President and Chief Executive Officer
|
||||
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Robert F. Apple
|
||||
Robert F. Apple
Executive Vice President and Chief Financial Officer
|
||||
CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) (USD $) | Sep. 30, 2011 | Dec. 31, 2010 |
---|---|---|
Stockholders' Equity: | ||
Preferred Stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred Stock, shares authorized (in shares) | 3,000,000 | 3,000,000 |
Preferred Stock, shares outstanding (in shares) | 0 | 0 |
Common Stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common Stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common Stock, shares issued (in shares) | 103,509,310 | 84,157,865 |
Common Stock, shares outstanding (in shares) | 103,509,310 | 84,157,865 |
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2011 | Sep. 30, 2010 | Sep. 30, 2011 | Sep. 30, 2010 | |
Revenue: | ||||
Product sales | $ 2,197,029 | $ 1,654,215 | $ 5,820,691 | $ 4,132,245 |
Development revenue | 952,557 | 401,723 | 2,725,275 | 1,704,165 |
Licensing revenue | 123,419 | 582,817 | 608,445 | 2,462,735 |
Royalties | 646,032 | 483,305 | 1,877,046 | 1,237,988 |
Total revenue | 3,919,037 | 3,122,060 | 11,031,457 | 9,537,133 |
Cost of revenue: | ||||
Cost of product sales | 1,028,376 | 798,532 | 2,741,783 | 2,047,357 |
Cost of development revenue | 778,674 | 280,982 | 1,911,397 | 1,343,097 |
Total cost of revenue | 1,807,050 | 1,079,514 | 4,653,180 | 3,390,454 |
Gross profit | 2,111,987 | 2,042,546 | 6,378,277 | 6,146,679 |
Operating expenses: | ||||
Research and development | 1,429,210 | 2,332,712 | 5,124,877 | 6,661,325 |
Sales, marketing and business development | 390,260 | 204,750 | 1,202,127 | 776,549 |
General and administrative | 1,559,018 | 1,170,041 | 4,325,699 | 3,509,630 |
Total Operating Expenses | 3,378,488 | 3,707,503 | 10,652,703 | 10,947,504 |
Operating loss | (1,266,501) | (1,664,957) | (4,274,426) | (4,800,825) |
Other income (expense) | (32,758) | 33,557 | 40,437 | 8,228 |
Net loss | $ (1,299,259) | $ (1,631,400) | $ (4,233,989) | $ (4,792,597) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.01) | $ (0.02) | $ (0.04) | $ (0.06) |
Basic and diluted weighted average common shares outstanding (in shares) | 103,311,772 | 83,615,043 | 94,793,953 | 82,937,306 |
Document And Entity Information (USD $) | 9 Months Ended | |
---|---|---|
Sep. 30, 2011 | Jun. 30, 2010 | |
Entity Registrant Name | Antares Pharma, Inc. | |
Entity Central Index Key | 0001016169 | |
Current Fiscal Year End Date | --12-31 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Public Float | $ 87,572,915 | |
Entity Common Stock, Shares Outstanding | 103,513,137 | |
Document Fiscal Year Focus | 2010 | |
Document Fiscal Period Focus | Q3 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2011 |
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Revenue Recognition | 9 Months Ended |
---|---|
Sep. 30, 2011 | |
Deferred Revenue Disclosure [Abstract] | |
Revenue Recognition | 7. Revenue Recognition In January of 2011, the Company amended the license, development and supply agreement with Teva originally entered into in December of 2007 under which the Company will develop and supply a disposable pen injector for use with two undisclosed patient-administered pharmaceutical products. Under the original agreement, an upfront payment, development milestones, and royalties on Teva’s product sales, as well as a purchase price for each device sold were to be received by the Company under certain circumstances. Based on an analysis under accounting literature applicable at the time of the agreement, the entire arrangement was considered a single unit of accounting. Therefore, payments received and 10 development costs incurred were deferred and were to be recognized from the start of manufacturing through the end of the initial contract period. Changes to the original agreement as a result of the amendment included the following: (i) Teva will pay for future device development activities, (ii) Teva will pay for and own all commercial tooling developed and produced under the agreement, and (iii) certain potential milestone payments were eliminated. The Company has determined that the changes to the agreement as a result of the amendment are a material modification to the agreement. Because the agreement was materially modified, the accounting was re-evaluated under the applicable current revenue recognition accounting standards. The re-evaluation resulted in the agreement being separated into multiple units of accounting and resulted in changes to both the method of revenue recognition and the period over which revenue will be recognized. The provisions of the current standards are to be applied as if they were applicable from inception of the agreement. Under the new accounting, the original license fee received will be recognized as revenue over the development period, the development milestone payments previously received were recognized as revenue immediately and revenue during the manufacturing period will be recognized as devices are sold and royalties are earned. For the nine months ended September 30, 2011, the accounting change resulting from the material modification resulted in recognition of development and licensing revenue previously deferred of $304,600 and $316,666, respectively, and recognition of costs previously deferred of $408,250. |
Stockholders' Equity | 9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity |
Common Stock In May 2011, the Company sold a total of 14,375,000 shares of common stock at a price of $1.60 per share in a public offering, which resulted in net proceeds of $21,280,718 after deducting offering expenses of $1,719,282.
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 ten to eleven years and they vest in varying periods. In May 2011, the shareholders approved an amendment to the Plan to increase the maximum number of shares authorized for issuance by 2,000,000 to 13,500,000 from 11,500,000. As of September 30, 2011, the Plan had 1,718,358 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 September 30, 2011, and the changes during the nine months then ended is as follows: 7
During the first nine months of 2011 and 2010 the Company granted options to purchase a total of 971,409 and 647,487 shares of its common stock, respectively. The options were granted at weighted average exercise prices of $1.75 and $1.49 in 2011 and 2010, respectively. All options were granted at exercise prices 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 $699,600 and $648,000 for the first nine months of 2011 and 2010, respectively. As of September 30, 2011, there was approximately $1,185,000 of total unrecognized compensation cost related to nonvested outstanding stock options that is expected to be recognized over a weighted average period of approximately 1.7 years. The per share weighted average fair value of options granted during the first nine months of 2011 and 2010 were estimated as $0.89 and $0.79 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.
In the first nine months of 2011, 3,307,759 warrants with exercise prices ranging from $1.50 to $2.00 were exercised resulting in proceeds to the Company of $4,994,450 and 800,000 warrants with an exercise price of $0.80 were exercised under a cashless provision resulting in the issuance of 417,513 shares of common stock. A total of 3,502,016 warrants with an exercise price of $1.50 expired unexercised. Warrants to purchase a total of 10,075,284 shares of common stock were outstanding at September 30, 2011. The weighted average exercise price of the warrants was $1.66. The weighted average exercise price of the stock options and warrants outstanding at September 30, 2011 and 2010 was $1.46 and $1.44, respectively. Stock Awards The employment agreements or performance stock bonus agreements with certain members of executive management include stock-based incentives under which the executives could be awarded shares of the Company’s common stock upon the occurrence of various triggering events. As of September 30, 2011, potential future awards under these agreements totaled approximately 275,000 shares of common stock. There were 145,454 and 45,454 shares awarded under these agreements in the first nine months of 2011 and 2010, respectively. At times, the Company grants shares of its common stock to members of management 8 and other employees in lieu of cash bonus awards or in recognition of special achievements. A total of 408,267 and 213,268 shares of common stock were granted as stock awards in the first nine months of 2011 and 2010, respectively. As of September 30, 2011, a total of 158,780 shares previously granted were unvested. 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 $754,460 and $213,800 in the first nine months of 2011 and 2010, respectively. The weighted average fair value of the shares granted in 2011 and 2010 was $1.81 and $1.34 per share, respectively. A portion of the shares vested in 2011 were net-share settled such that the Company withheld shares with value equivalent to the employees’ minimum statutory obligation for the applicable income and other employment taxes, and remitted the cash to the appropriate taxing authorities. The total shares withheld were 121,182, and were based on the value of the shares on their vesting date as determined by the Company’s closing stock price. Total payments for the employees’ tax obligations to the taxing authorities were $233,291 and are reflected as a financing activity within the Consolidated Statements of Cash Flows. These net-share settlements had the effect of share repurchases by the Company as they reduced the number of shares that would have otherwise been issued as a result of the vesting and did not represent an expense to the Company. Long Term Incentive Program On May 17, 2011, the Board of Directors of the Company approved a new long term incentive program for the benefit of its executive officers. Pursuant to the long term incentive program, the Company’s executive officers were awarded stock options and performance stock units with a value targeted at the median level of the Company’s peer group as disclosed in its 2011 definitive proxy statement. Two thirds of that value for each officer is delivered in the form of stock options and one third of that value is delivered in the form of performance stock units. A total of 317,000 options were granted on May 17, 2011 under this program. The stock options (i) have a ten-year term, (ii) have an exercise price equal to the closing price of the Company’s common stock, as reported on AMEX, on the date of grant ($1.66), (iii) vest in quarterly installments over three years, and (iv) were otherwise granted on the same standard terms and conditions as other stock options granted pursuant to the Plan. The performance stock unit awards made to the executive officers will be vested and convert into actual shares of the Company’s common stock based on the Company’s attainment of certain performance goals measured over the three-year period beginning January 1, 2011 and ending December 31, 2013 and the executive officer’s continued employment with the Company through that period. Each performance criterion has levels of achievement designated as threshold, target and maximum with 50% of the performance stock units vesting if the threshold level is achieved; 100% of the performance stock units vesting if the target level is achieved and 150% of the performance stock units vesting if the maximum level is achieved. A total of 182,000 performance stock units were awarded at the target level. In the event that the actual performance level achieved does not meet threshold performance (i.e., less than 50%) for an applicable performance measure, then no performance stock units will be earned and vested for that performance measure. Threshold level performance may be achieved for one performance measure and not another based on the Company’s actual performance during the three year performance period. |
New Accounting Pronouncements | 9 Months Ended |
---|---|
Sep. 30, 2011 | |
New Accounting Pronouncements [Abstract] | |
New Accounting Pronouncements | 9. New Accounting Pronouncements In January 2010, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2010-06 (“ASU 2010-06”), Fair Value Measurements and Disclosures (Topic 820), “Improving Disclosures about Fair Value Measurements.” ASU 2010-06 requires new disclosures about significant transfers in and out of Level 1 and Level 2 fair value measurements and the reasons for such transfers and in the reconciliation for Level 3 fair value measurements to disclose separately information about purchases, sales, issuances and settlements. ASU 2010-06 is effective for interim and annual reporting periods beginning after December 15, 2009, except for disclosures about purchases, sales, issuances and settlements in the reconciliation for Level 3 fair value measurements. Those disclosures are effective for fiscal years beginning after December 15, 2010. The adoption of ASU 2010-06 did not have an impact on the Company’s consolidated financial statements. In April 2010, the FASB issued authoritative 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 recent guidance discusses the criteria that should be met for determining whether the milestone method of revenue recognition is appropriate. The guidance is effective for fiscal years and interim periods within those years beginning on or after June 15, 2010, with early adoption permitted. This guidance was effective for us on January 1, 2011. Adoption of this guidance has not had a material impact on the Company’s consolidated financial statements as the Company has not received any milestone payments after the effective date. |
License Agreements | 9 Months Ended |
---|---|
Sep. 30, 2011 | |
License Agreements [Abstract] | |
License Agreements [Text Block] | 8. License Agreements On July 11, 2011, the Company announced with Watson Pharmaceuticals, Inc. an exclusive licensing agreement for Watson to commercialize the Company’s topical oxybutynin gel product, Anturol®, in the U.S. and Canada. A New Drug Application for Anturol® is currently under review by the Food and Drug Administration (“FDA”). The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) date of December 8, 2011. Under terms of the agreement, Watson will make payments for certain manufacturing start-up activities and will make milestone payments based on the achievement of regulatory approval and certain sales levels. Upon launch of the product, the Company will receive escalating royalties based on product sales in the U.S. and Canada. A portion of the milestone payments based on the achievement of regulatory approval is subject to reimbursement to Watson if launch quantities are not delivered within a certain defined time period. After delivery of initial launch quantities to Watson by the Company, Watson will assume responsibility for manufacture and supply of the product. Arrangement consideration will be allocated to the separate units of accounting based on the relative selling prices. Selling prices are determined using vendor specific objective evidence (“VSOE”), when available, third-party evidence (“TPE”), when available, or an estimate of selling price when neither of the first two options is available for a given unit of accounting. Selling prices in this arrangement were determined using estimated selling prices because VSOE and TPE were not available. The primary factors considered in determining selling price estimates in this arrangement were estimated costs, reasonable margin estimates and historical experience. As is typical with the Company’s multi-element arrangements, the Company has determined that the license and development activities, which include the manufacturing start-up activities, do not have value to the customer on a stand-alone basis as proprietary knowledge about the product and technology is required to complete the development activities. As a result, these deliverables do not qualify for treatment as separate units of accounting. Accordingly, the license and development activities will be accounted for as a single unit of accounting and arrangement consideration allocated to these deliverables will be recognized as revenue over the development period, which ends upon delivery of launch quantities. The sales based milestone payments will be recognized as revenue when earned, revenue for launch quantities will be recognized when product is delivered to Watson and royalties will be recognized as revenue when earned. Revenue recognition for a portion of the milestone payments based on the achievement of regulatory approval will be dependent upon delivery of launch quantities to Watson by the Company. For the three-month and nine-month periods ended September, 30, 2011, the Company has recognized revenue of $432,000 in connection with manufacturing start-up activities. |
Description of Business | 9 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2011 | |||||||||
Description of Business [Abstract] | |||||||||
Description of Business | 1. Description of Business
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Net Loss Per Share | 9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss 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 their effect was anti-dilutive totaled 17,921,283 and 25,225,596 at September 30, 2011 and 2010, respectively. The table below discloses the basic and diluted loss per common share. 9
|
Industry Segment and Operations by Geographic Areas | 9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Industry Segment and Operations by Geographic Areas [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Industry Segment and Operations by Geographic Areas | 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. Revenues by customer location are summarized as follows:
|
Comprehensive Loss | 9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Loss [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Loss | 6. Comprehensive Loss
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Basis of Presentation | 9 Months Ended | ||||||||||||||||
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Sep. 30, 2011 | |||||||||||||||||
Basis of Presentation [Abstract] | |||||||||||||||||
Basis of Presentation |
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