x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Massachusetts
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04-3145961
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(State or Other Jurisdiction of
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(I.R.S. Employer Identification No.)
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Incorporation or Organization)
|
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32 Wiggins Avenue, Bedford, Massachusetts
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01730
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(Address of Principal Executive Offices)
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(Zip Code)
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Large accelerated filer o
|
Accelerated filer x
|
Non-accelerated filer o
(Do not check if a smaller
reporting company)
|
Smaller reporting
company o
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Anika Therapeutics, Inc. and Subsidiaries
|
||||||||
Condensed Consolidated Balance Sheets
|
||||||||
(unaudited)
|
||||||||
June 30,
|
December 31,
|
|||||||
2013
|
2012
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 54,140,459 | $ | 44,067,477 | ||||
Accounts receivable, net of reserves of $332,148 and $337,459 at June 30, 2013
and December 31, 2012, respectively
|
19,065,386 | 21,462,481 | ||||||
Inventories
|
10,357,798 | 8,283,472 | ||||||
Current portion deferred income taxes
|
1,989,422 | 2,031,583 | ||||||
Prepaid expenses and other
|
920,873 | 1,539,477 | ||||||
Total current assets
|
86,473,938 | 77,384,490 | ||||||
Property and equipment, at cost
|
51,618,726 | 52,376,013 | ||||||
Less: accumulated depreciation
|
(17,772,147 | ) | (17,263,032 | ) | ||||
33,846,579 | 35,112,981 | |||||||
Long-term deposits and other
|
154,050 | 171,053 | ||||||
Intangible assets, net
|
18,996,886 | 20,334,636 | ||||||
Goodwill
|
8,923,197 | 9,065,891 | ||||||
Total Assets
|
$ | 148,394,650 | $ | 142,069,051 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 2,699,678 | $ | 2,341,838 | ||||
Accrued expenses
|
4,503,551 | 5,837,044 | ||||||
Deferred revenue
|
1,527,917 | 2,875,067 | ||||||
Current portion of long-term debt
|
1,600,000 | 1,600,000 | ||||||
Income taxes payable
|
1,370,172 | 1,798,669 | ||||||
Total current liabilities
|
11,701,318 | 14,452,618 | ||||||
Other long-term liabilities
|
1,264,427 | 1,541,124 | ||||||
Long-term deferred revenue
|
2,069,444 | 2,152,778 | ||||||
Deferred tax liability
|
6,725,622 | 6,997,397 | ||||||
Long-term debt
|
7,200,000 | 8,000,000 | ||||||
Commitments and contingencies (Note 10)
|
- | - | ||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued
and outstanding at June 30, 2013 and December 31, 2012, respectively
|
- | - | ||||||
Common stock, $.01 par value; 30,000,000 shares authorized, 14,017,280 and
13,866,060 shares issued and outstanding at June 30, 2013 and December 31, 2012,
respectively
|
140,173 | 138,659 | ||||||
Additional paid-in-capital
|
67,385,076 | 65,431,424 | ||||||
Accumulated currency translation adjustment
|
(3,063,985 | ) | (2,654,630 | ) | ||||
Retained earnings
|
54,972,575 | 46,009,681 | ||||||
Total stockholders’ equity
|
119,433,839 | 108,925,134 | ||||||
Total Liabilities and Stockholders’ Equity
|
$ | 148,394,650 | $ | 142,069,051 |
Anika Therapeutics, Inc. and Subsidiaries
|
||||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Income
|
||||||||||||||||
(unaudited)
|
||||||||||||||||
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2013
|
2012
|
2013
|
2012
|
|||||||||||||
Product revenue
|
$ | 20,067,407 | $ | 18,882,277 | $ | 34,561,896 | $ | 32,495,605 | ||||||||
Licensing, milestone and contract revenue
|
760,970 | 742,492 | 1,513,492 | 1,489,824 | ||||||||||||
Total revenue
|
20,828,377 | 19,624,769 | 36,075,388 | 33,985,429 | ||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of product revenue
|
6,311,332 | 8,084,226 | 11,152,502 | 14,497,707 | ||||||||||||
Research & development
|
1,829,052 | 1,298,170 | 3,411,962 | 2,831,273 | ||||||||||||
Selling, general & administrative
|
3,400,679 | 4,108,503 | 7,347,793 | 7,459,519 | ||||||||||||
Restructuring charges
|
(111,178 | ) | - | (246,785 | ) | - | ||||||||||
Total operating expenses
|
11,429,885 | 13,490,899 | 21,665,472 | 24,788,499 | ||||||||||||
Income from operations
|
9,398,492 | 6,133,870 | 14,409,916 | 9,196,930 | ||||||||||||
Interest income (expense), net
|
(36,381 | ) | (49,129 | ) | (75,939 | ) | (100,332 | ) | ||||||||
Income before income taxes
|
9,362,111 | 6,084,741 | 14,333,977 | 9,096,598 | ||||||||||||
Provision for income taxes
|
3,467,219 | 2,347,873 | 5,371,083 | 3,447,611 | ||||||||||||
Net income
|
$ | 5,894,892 | $ | 3,736,868 | $ | 8,962,894 | $ | 5,648,987 | ||||||||
Basic net income per share:
|
||||||||||||||||
Net income
|
$ | 0.44 | $ | 0.28 | $ | 0.67 | $ | 0.43 | ||||||||
Basic weighted average common shares outstanding
|
13,510,573 | 13,262,023 | 13,459,049 | 13,212,424 | ||||||||||||
Diluted net income per share:
|
||||||||||||||||
Net income
|
$ | 0.40 | $ | 0.26 | $ | 0.62 | $ | 0.39 | ||||||||
Diluted weighted average common shares outstanding
|
14,578,927 | 14,443,794 | 14,484,978 | 14,302,439 | ||||||||||||
Net income
|
$ | 5,894,892 | $ | 3,736,868 | $ | 8,962,894 | $ | 5,648,987 | ||||||||
Other comprehensive income
|
||||||||||||||||
Foreign currency translation adjustment
|
340,095 | (1,600,204 | ) | (409,355 | ) | (843,743 | ) | |||||||||
Comprehensive income
|
$ | 6,234,987 | $ | 2,136,664 | $ | 8,553,539 | $ | 4,805,244 |
Anika Therapeutics, Inc. and Subsidiaries
|
||||||||
Condensed Consolidated Statements of Cash Flows
|
||||||||
(unaudited)
|
||||||||
Six Months Ended June 30,
|
||||||||
2013
|
2012
|
|||||||
Cash flows from operating activities:
|
||||||||
Net income
|
$ | 8,962,894 | $ | 5,648,987 | ||||
Adjustments to reconcile net income to net cash provided by operating activities:
|
||||||||
Depreciation and amortization
|
2,270,895 | 2,182,129 | ||||||
Stock-based compensation expense
|
788,326 | 633,073 | ||||||
Deferred income taxes
|
(269,149 | ) | 14,036 | |||||
Provision for doubtful accounts
|
- | 135,353 | ||||||
Provision for inventory
|
229,885 | 164,300 | ||||||
Tax benefit from exercise of stock options
|
(7,596 | ) | (400,325 | ) | ||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
1,796,522 | (892,265 | ) | |||||
Inventories
|
(2,324,269 | ) | (3,713,817 | ) | ||||
Prepaid expenses, other current and long-term assets
|
703,303 | 590,614 | ||||||
Long-term deposits and other
|
16,998 | 16,997 | ||||||
Accounts payable
|
878,228 | (170,035 | ) | |||||
Accrued expenses
|
(1,270,885 | ) | (920,168 | ) | ||||
Deferred revenue
|
(1,430,484 | ) | (1,433,334 | ) | ||||
Income taxes payable
|
(440,210 | ) | 1,679,579 | |||||
Other long-term liabilities
|
(271,532 | ) | (335 | ) | ||||
Net cash provided by operating activities
|
9,632,926 | 3,534,789 | ||||||
Cash flows from investing activities:
|
||||||||
Proceeds from sales of assets
|
246,785 | - | ||||||
Purchase of property and equipment, net
|
(109,871 | ) | (1,145,493 | ) | ||||
Net cash provided by (used in) investing activities
|
136,914 | (1,145,493 | ) | |||||
Cash flows from financing activities:
|
||||||||
Principal payments on debt
|
(800,000 | ) | (800,000 | ) | ||||
Proceeds from exercise of stock options
|
1,127,875 | 147,033 | ||||||
Tax benefit from exercise of stock options
|
7,596 | 400,325 | ||||||
Net cash provided by (used in) financing activities
|
335,471 | (252,642 | ) | |||||
Exchange rate impact on cash
|
(32,329 | ) | (4,268 | ) | ||||
Increase in cash and cash equivalents
|
10,072,982 | 2,132,386 | ||||||
Cash and cash equivalents at beginning of period
|
44,067,477 | 35,777,222 | ||||||
Cash and cash equivalents at end of period
|
$ | 54,140,459 | $ | 37,909,608 |
|
•
|
Level 1 – Valuation is based upon quoted prices for identical instruments traded in active markets. Level 1 instruments include securities traded on active exchange markets, such as the New York Stock Exchange.
|
|
•
|
Level 2 – Valuation is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market.
|
|
•
|
Level 3 – Valuation is generated from model-based techniques that use significant assumptions not observable in the market. These unobservable assumptions reflect our own estimates of assumptions market participants would use in pricing the asset or liability.
|
Three Months Ended
|
|||
June 30,
|
|||
2013
|
2012
|
||
Risk free interest rate
|
0.65%
|
-
|
|
Expected volatility
|
57.60%
|
-
|
|
Expected lives (years)
|
4
|
-
|
|
Expected dividend yield
|
0.00%
|
-
|
|
Six Months Ended
|
|||
June 30,
|
|||
2013
|
2012
|
||
Risk free interest rate
|
0.61% - 0.70%
|
0.64%
|
|
Expected volatility
|
57.60%
|
57.60%
|
|
Expected lives (years)
|
4
|
4
|
|
Expected dividend yield
|
0.00%
|
0.00%
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
2013
|
2012
|
2013
|
2012
|
|||||||||||||
Shares used in the calculation of Basic earnings per share
|
13,510,573 | 13,262,023 | 13,459,049 | 13,212,424 | ||||||||||||
Effect of dilutive securities:
|
||||||||||||||||
Stock options, SARs, RSAs, and shares held in escrow
|
1,068,354 | 1,181,771 | 1,025,929 | 1,090,015 | ||||||||||||
Diluted shares used in the calculation of earnings per share
|
14,578,927 | 14,443,794 | 14,484,978 | 14,302,439 |
June 30,
|
December 31,
|
|||||||
2013
|
2012
|
|||||||
Raw materials
|
$ | 6,160,860 | $ | 6,109,807 | ||||
Work-in-process
|
2,016,882 | 777,056 | ||||||
Finished goods
|
2,180,056 | 1,396,609 | ||||||
Total
|
$ | 10,357,798 | $ | 8,283,472 |
June 30, 2013
|
December 31, 2012 | ||||||||||||||||||||||
Gross Value
|
Currency
Translation
Adjustment
|
Accumulated Amortization
|
Net Book Value
|
Net Book Value
|
Useful Life
|
||||||||||||||||||
Developed technology
|
$ | 16,700,000 | $ | (1,609,247 | ) | $ | (3,472,667 | ) | $ | 11,618,086 | $ | 12,370,042 | 15 | ||||||||||
In-process research & development
|
5,502,686 | (512,634 | ) | - | 4,990,052 | 4,980,574 |
Indefinite
|
||||||||||||||||
Distributor relationships
|
4,700,000 | (483,620 | ) | (2,972,514 | ) | 1,243,866 | 1,733,453 | 5 | |||||||||||||||
Patents
|
1,000,000 | (96,203 | ) | (197,640 | ) | 706,157 | 749,166 | 16 | |||||||||||||||
Elevess trade name
|
1,000,000 | - | (561,275 | ) | 438,725 | 501,401 | 9 | ||||||||||||||||
Total
|
$ | 28,902,686 | $ | (2,701,704 | ) | $ | (7,204,096 | ) | $ | 18,996,886 | $ | 20,334,636 |
For the three
months ended:
|
For the six
months ended:
|
|||||||
June 30,
|
June 30,
|
|||||||
2013
|
2013
|
|||||||
Balance, beginning
|
$ | 8,792,165 | $ | 9,065,891 | ||||
Effect of foreign currency adjustments
|
131,032 | (142,694 | ) | |||||
Balance, ending
|
$ | 8,923,197 | $ | 8,923,197 |
June 30,
|
December 31,
|
|||||||
2013
|
2012
|
|||||||
Payroll and benefits
|
$ | 2,162,634 | $ | 2,477,833 | ||||
Professional fees
|
469,991 | 642,853 | ||||||
Clinical trial costs
|
67,767 | 102,414 | ||||||
Restructuring costs
|
283,063 | 933,732 | ||||||
Other
|
1,520,096 | 1,680,212 | ||||||
Total
|
$ | 4,503,551 | $ | 5,837,044 |
Agreement Type
|
Description
|
Term in Years
|
Lease
|
Rent of space in Abano Terme, Italy
|
Six
|
Finished goods supply
|
Manufacture and supply of goods
|
Five
|
Raw material supply
|
Hyaluronic acid powder
|
(EXPIRED)
|
Services
|
Finance, administrative, security and other
|
One to Six
|
Accounts receivable management
|
Collection of trade receivables outstanding as of December 30, 2009
|
(EXPIRED)
|
Marketing and promotion
|
Promote Anika Srl products in Italy through Fidia sales force
|
(TERMINATED)
|
Three Months Ended June 30,
|
Six Months Ended June 30, | |||||||||||||||
2013
|
2012
|
2013
|
2012
|
|||||||||||||
Orthobiologics
|
$ | 16,506,226 | $ | 10,903,364 | $ | 27,789,773 | $ | 21,020,209 | ||||||||
Dermal
|
557,059 | 155,735 | 798,643 | 657,051 | ||||||||||||
Surgical
|
1,830,022 | 1,464,505 | 2,818,886 | 2,448,133 | ||||||||||||
Ophthalmic
|
464,340 | 5,299,732 | 1,392,798 | 6,623,726 | ||||||||||||
Veterinary
|
709,760 | 1,058,941 | 1,761,796 | 1,746,486 | ||||||||||||
$ | 20,067,407 | $ | 18,882,277 | $ | 34,561,896 | $ | 32,495,605 |
Three Months Ended June 30,
|
||||||||||||||||
2013
|
2012
|
|||||||||||||||
Percentage of
|
Percentage of
|
|||||||||||||||
Revenue
|
Revenue
|
Revenue
|
Revenue
|
|||||||||||||
Geographic Location:
|
||||||||||||||||
United States
|
$ | 15,482,068 | 74 | % | $ | 16,728,331 | 85 | % | ||||||||
Europe
|
1,986,195 | 10 | % | 1,128,126 | 6 | % | ||||||||||
Other
|
3,360,114 | 16 | % | 1,768,312 | 9 | % | ||||||||||
Total
|
$ | 20,828,377 | 100 | % | $ | 19,624,769 | 100 | % |
Six Months Ended June 30,
|
||||||||||||||||
2013
|
2012
|
|||||||||||||||
Percentage of
|
Percentage of
|
|||||||||||||||
Revenue
|
Revenue
|
Revenue
|
Revenue
|
|||||||||||||
Geographic Location:
|
||||||||||||||||
United States
|
$ | 27,765,515 | 77 | % | $ | 27,835,044 | 82 | % | ||||||||
Europe
|
3,569,963 | 10 | % | 2,929,543 | 9 | % | ||||||||||
Other
|
4,739,910 | 13 | % | 3,220,842 | 9 | % | ||||||||||
Total
|
$ | 36,075,388 | 100 | % | $ | 33,985,429 | 100 | % |
Restructuring Accrual
|
||||||||||||
Employee
Severance and
Related Benefits
|
Activity
Termination and
Facility Closure
Costs
|
Total
|
||||||||||
December 31, 2012
|
$ | 801,453 | $ | 132,279 | $ | 933,732 | ||||||
Charges to Operations
|
- | - | - | |||||||||
Cash Proceeds, Disbursements
|
(613,870 | ) | (45,240 | ) | (659,110 | ) | ||||||
Write Offs and Abandonments
|
- | - | - | |||||||||
Foreign Exchange Impact
|
8,422 | 19 | 8,441 | |||||||||
June 30, 2013
|
$ | 196,005 | $ | 87,058 | $ | 283,063 |
●
|
Our expectations regarding future sales and product revenue, including geographic expansions, possible retroactive price adjustments, and expectations of unit volumes or other offsets to price reductions, for our products;
|
●
|
Our manufacturing capacity and efficiency gains and work-in-process manufacturing operations;
|
●
|
The timing, scope and rate of patient enrollment for clinical trials;
|
●
|
The development of possible line extensions and new products;
|
●
|
Our ability to achieve or maintain compliance with laws and regulations;
|
●
|
The timing of and/or receipt of Food and Drug Administration, foreign or other regulatory approvals, clearances, and/or reimbursement approvals and changes of current, new or potential products, and any limitations on such approvals and/ changes;
|
●
|
Our intention to seek patent protection for our products and processes, and protect our intellectual property;
|
●
|
Our ability to effectively compete against current and future competitors;
|
●
|
Negotiations with potential and existing partners, including our performance under any of our existing and future distribution or supply agreements or our expectations with respect to sales and sales threshold milestones pursuant to such agreements;
|
●
|
The level of our revenue or sales in particular geographic areas and/or for particular products, and the market share for any of our products;
|
●
|
Our current strategy, including our corporate objectives, research and development, and collaboration activities;
|
●
|
Our and Bausch & Lomb’s performance under the non-exclusive supply agreement for AMVISC® and AMVISC® Plus ophthalmic viscoelastic products that expires on December 31, 2014, and our expectations regarding revenue generated from ophthalmic products;
|
●
|
Our ability to commercialize AnikaVisc and AnikaVisc Plus, and our expectations regarding such commercialization and the potential revenue generated thereby;
|
●
|
Our expectations regarding our orthobiologics products, including expectations regarding new products, expanded uses of existing products, new distribution partnerships, and revenue growth;
|
●
|
Our intention to increase market share for our orthobiologics products in international and domestic markets or otherwise penetrate growing markets for osteoarthritis of the knee and other joints;
|
●
|
Our expectations regarding next generation osteoarthritis/orthobiologics product developments, clinical trials, regulatory approvals and commercial launches;
|
●
|
Our ability to license our aesthetics product to new distribution partners domestically and internationally; our ability, and the ability of our distribution partners, to market our aesthetic dermatology product; and our expectations regarding the distribution and sales of our HYDRELLE™/ELEVESS™ products and the timing thereof;
|
●
|
Our expectations regarding our existing aesthetics product line’s extensions;
|
●
|
Our expectations regarding product gross margin and profit;
|
●
|
Our expectations regarding U.S. MONOVISCTM and the results of the related premarket approval (“PMA”) filing with the FDA, including our PMA amendment in connection with recent discussions with the FDA following their rejection of our appeal of the non-approvable letter, and the likelihood of our obtaining such approval and/or the anticipated timing thereof;
|
●
|
Our expectations regarding the completion of CINGAL™ clinical trial, including the expense associated therewith, and our ability to obtain regulatory approvals for CINGAL;
|
●
|
Our expectation for changes in operating expenses, including research and development and selling, general and administrative expenses;
|
●
|
The rate at which we use cash, the amounts used and generated by operations, and our expectation regarding the adequacy of such cash;
|
●
|
Our expectation for capital expenditures spending and future amounts of interest income and expense;
|
●
|
Our ability to continue streamlining operations and improving our manufacturing activities and general business operations;
|
●
|
Possible negotiations or re-negotiations with existing or new distribution or collaboration partners;
|
●
|
Our ability to remain in compliance with debt covenants;
|
●
|
Our ability to obtain additional funds through equity or debt financings, strategic alliances with corporate partners and other sources, to the extent our current sources of funds are insufficient;
|
●
|
Our ability to successfully complete the restructuring of Anika S.r.l., including the closing of the tissue engineering facility in Abano Treme, Italy, and manage its operation from one with losses, into a company generating profits;
|
●
|
Our abilities to effectively commercialize the many research and development projects underway;
|
●
|
Our ability to obtain U.S. approval for the orthopedic and other product franchises of Anika S.r.l., including the timing and potential success of such efforts, and to expand sales of these products in the U.S., including the impact such efforts may have on our revenue;
|
●
|
Our ability to satisfactorily resolve the dispute with Fidia Farmaceutici S.p.A regarding the Merogel Injectable product; and
|
●
|
Our ability to successfully defend the Company against lawsuits and claims, including the Genzyme lawsuit, and the uncertain financial impact such lawsuits and claims and related defense costs may have on the Company.
|
Anika
|
Anika
S.r.l.
|
|
Orthobiologics
|
X
|
X
|
Dermal
Advanced wound care
Aesthetic dermatology
|
X
|
X
|
Surgical
Anti-adhesion
Ear, nose and throat care (“ENT”)
|
X
|
X
X
|
Ophthalmic
|
X
|
|
Veterinary
|
X
|
Three and Six Months Ended June 30, 2013 Compared to the Three and Six Months Ended June 30, 2012
|
||||||||||||||||||||||||||||||||
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||||||||||||||||||
2013
|
2012
|
$
Inc/(Dec)
|
%
Inc/(Dec)
|
2013
|
2012
|
$
Inc/(Dec)
|
%
Inc/(Dec)
|
|||||||||||||||||||||||||
Product revenue
|
$ | 20,067,407 | $ | 18,882,277 | $ | 1,185,130 | 6 | % | $ | 34,561,896 | $ | 32,495,605 | $ | 2,066,291 | 6 | % | ||||||||||||||||
Licensing, milestone and contract revenue
|
760,970 | 742,492 | 18,478 | 2 | % | 1,513,492 | 1,489,824 | 23,668 | 2 | % | ||||||||||||||||||||||
Total revenue
|
20,828,377 | 19,624,769 | 1,203,608 | 6 | % | 36,075,388 | 33,985,429 | 2,089,959 | 6 | % | ||||||||||||||||||||||
Operating expenses:
|
||||||||||||||||||||||||||||||||
Cost of product revenue
|
6,311,332 | 8,084,226 | (1,772,894 | ) | (22 | %) | 11,152,502 | 14,497,707 | (3,345,205 | ) | (23 | %) | ||||||||||||||||||||
Research & development
|
1,829,052 | 1,298,170 | 530,882 | 41 | % | 3,411,962 | 2,831,273 | 580,689 | 21 | % | ||||||||||||||||||||||
Selling, general & administrative
|
3,400,679 | 4,108,503 | (707,824 | ) | (17 | %) | 7,347,793 | 7,459,519 | (111,726 | ) | (1 | %) | ||||||||||||||||||||
Restructuring charges
|
(111,178 | ) | - | (111,178 | ) | N/M | (246,785 | ) | - | (246,785 | ) | N/M | ||||||||||||||||||||
Total operating expenses
|
11,429,885 | 13,490,899 | (2,061,014 | ) | (15 | %) | 21,665,472 | 24,788,499 | (3,123,027 | ) | (13 | %) | ||||||||||||||||||||
Income from operations
|
9,398,492 | 6,133,870 | 3,264,622 | 53 | % | 14,409,916 | 9,196,930 | 5,212,986 | 57 | % | ||||||||||||||||||||||
Interest income (expense), net
|
(36,381 | ) | (49,129 | ) | 12,748 | (26 | %) | (75,939 | ) | (100,332 | ) | 24,393 | (24 | %) | ||||||||||||||||||
Income before income taxes
|
9,362,111 | 6,084,741 | 3,277,370 | 54 | % | 14,333,977 | 9,096,598 | 5,237,379 | 58 | % | ||||||||||||||||||||||
Provision for income taxes
|
3,467,219 | 2,347,873 | 1,119,346 | 48 | % | 5,371,083 | 3,447,611 | 1,923,472 | 56 | % | ||||||||||||||||||||||
Net income
|
$ | 5,894,892 | $ | 3,736,868 | $ | 2,158,024 | 58 | % | $ | 8,962,894 | $ | 5,648,987 | $ | 3,313,907 | 59 | % | ||||||||||||||||
Product gross profit
|
13,756,075 | 10,798,051 | 2,958,024 | 27 | % | 23,409,394 | 17,997,898 | 5,411,496 | 30 | % | ||||||||||||||||||||||
Product gross margin
|
69 | % | 57 | % | 68 | % | 55 | % |
Three Months Ended June 30,
|
Increase (Decrease)
|
|||||||||||||||
2013
|
2012
|
$ | % | |||||||||||||
Orthobiologics
|
$ | 16,506,226 | $ | 10,903,364 | $ | 5,602,862 | 51 | % | ||||||||
Dermal
|
557,059 | 155,735 | 401,324 | 258 | % | |||||||||||
Surgical
|
1,830,022 | 1,464,505 | 365,517 | 25 | % | |||||||||||
Ophthalmic
|
464,340 | 5,299,732 | (4,835,392 | ) | (91 | %) | ||||||||||
Veterinary
|
709,760 | 1,058,941 | (349,181 | ) | (33 | %) | ||||||||||
$ | 20,067,407 | $ | 18,882,277 | $ | 1,185,130 | 6 | % |
Six Months Ended June 30,
|
Increase (Decrease)
|
|||||||||||||||
2013
|
2012
|
$ | % | |||||||||||||
Orthobiologics
|
$ | 27,789,773 | $ | 21,020,209 | $ | 6,769,564 | 32 | % | ||||||||
Dermal
|
798,643 | 657,051 | 141,592 | 22 | % | |||||||||||
Surgical
|
2,818,886 | 2,448,133 | 370,753 | 15 | % | |||||||||||
Ophthalmic
|
1,392,798 | 6,623,726 | (5,230,928 | ) | (79 | %) | ||||||||||
Veterinary
|
1,761,796 | 1,746,486 | 15,310 | 1 | % | |||||||||||
$ | 34,561,896 | $ | 32,495,605 | $ | 2,066,291 | 6 | % |
(a)
|
Evaluation of disclosure controls and procedures.
|
(b)
|
Changes in internal controls over financial reporting.
|
Exhibit No.
|
Description
|
|||
(31)
|
Rule 13a-14(a)/15d-14(a) Certifications | |||
*31.1
|
Certification of Charles H. Sherwood, Ph.D. pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||
*31.2
|
Certification of Sylvia Cheung pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||
(32)
|
Section 1350 Certifications | |||
**32.1
|
Certification of Charles H. Sherwood, Ph.D. and Sylvia Cheung, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||
(101)
|
XBRL | |||
101§
|
The following materials from Anika Therapeutics, Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, as filed with the SEC on August 5, 2013, formatted in XBRL (eXtensible Business Reporting Language), as follows: | |||
i. | Condensed Consolidated Balance Sheets as of June 30, 2013 (unaudited) and December 31, 2012 | |||
ii. | Condensed Consolidated Statements of Operations and Comprehensive Income for the Three and Six Months Ended June 30, 2013 and June 30, 2012 (unaudited) | |||
iii. | Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2013 and June 30, 2012 (unaudited) | |||
iv. | Notes to Condensed Consolidated Financial Statements (unaudited) |
*
|
Filed herewith
|
**
|
Furnished herewith.
|
§
|
As provided in Rule 406T of Regulation S-T, this information is furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933, as amended, and Section 18 of the Securities Exchange Act of 1934, as amended.
|
ANIKA THERAPEUTICS, INC.
|
||
August 6, 2013
|
By:
|
/s/ SYLVIA CHEUNG
|
Sylvia Cheung
|
||
Chief Financial Officer
|
||
(Authorized Officer and Principal Financial Officer)
|
1.
|
I have reviewed this report on Form 10-Q for the quarterly period ended June 30, 2013 of Anika Therapeutics, 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(s) 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 15d-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(s) 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.
|
Date: August 6, 2013
|
/s/ CHARLES H. SHERWOOD
|
Charles H. Sherwood, Ph.D.
|
|
Chief Executive Officer
|
|
Principal Executive Officer
|
1.
|
I have reviewed this report on Form 10-Q for the quarterly period ended June 30, 2013 of Anika Therapeutics, 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(s) 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 15d-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(s) 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.
|
Date: August 6, 2013
|
/s/ SYLVIA CHEUNG
|
Sylvia Cheung
|
|
Chief Financial Officer
|
|
Principal Financial Officer
|
Date: August 6, 2013
|
/s/ CHARLES H. SHERWOOD
|
Charles H. Sherwood, Ph.D.
|
|
Chief Executive Officer
|
|
Principal Executive Officer
|
|
Date: August 6, 2013
|
/s/ SYLVIA CHEUNG
|
Sylvia Cheung
|
|
Chief Financial Officer
|
|
Principal Financial Officer
|
Income Taxes
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Income Taxes |
12. Income
Taxes
Provisions
for income taxes were $3,467,219 and $5,371,083 for the three and
six-month periods ended June 30, 2013, respectively, based on
effective tax rates of 37.0 % and 37.5 %. Provisions for income
taxes were $2,347,873 and $3,447,611 for the three and six-month
periods ended June 30, 2012, respectively, based on effective tax
rates of 38.6% and 37.9%. The decrease in the effective tax rates
for the periods ended 2013, as compared to the same periods in the
previous year, are primarily due to increases in anticipated tax
credits and subsidiary earnings at a lower tax rate.
In
the normal course of business, Anika and its subsidiaries may be
periodically examined by various taxing authorities. We file income
tax returns in the U.S. federal jurisdiction, in certain U.S.
states, and in Italy. The associated tax filings remain subject to
examination by applicable tax authorities for a certain length of
time following the tax year to which those filings relate. The 2009
through 2012 tax years remain subject to examination by the IRS and
other taxing authorities for U.S. federal and state purposes. The
2009 through 2012 tax years remain subject to examination by the
appropriate governmental authorities in Italy.
In
connection with the preparation of the financial statements, the
Company performed an analysis to ascertain if it was more likely
than not that it would be able to utilize, in future periods, the
net deferred tax assets associated with its net operating loss
carryforward and its investment tax credit carryforward. We have
concluded that the positive evidence outweighs the negative
evidence and, thus, that those deferred tax assets are realizable
on a “more likely than not” basis. As such, we have not
recorded a valuation allowance at June 30, 2013 or
December 31, 2012, respectively.
|
Condensed Consolidated Statements of Operations and Comprehensive Income (unaudited) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Product revenue | $ 20,067,407 | $ 18,882,277 | $ 34,561,896 | $ 32,495,605 |
Licensing, milestone and contract revenue | 760,970 | 742,492 | 1,513,492 | 1,489,824 |
Total revenue | 20,828,377 | 19,624,769 | 36,075,388 | 33,985,429 |
Operating expenses: | ||||
Cost of product revenue | 6,311,332 | 8,084,226 | 11,152,502 | 14,497,707 |
Research & development | 1,829,052 | 1,298,170 | 3,411,962 | 2,831,273 |
Selling, general & administrative | 3,400,679 | 4,108,503 | 7,347,793 | 7,459,519 |
Restructuring charges | (111,178) | (246,785) | ||
Total operating expenses | 11,429,885 | 13,490,899 | 21,665,472 | 24,788,499 |
Income from operations | 9,398,492 | 6,133,870 | 14,409,916 | 9,196,930 |
Interest income (expense), net | (36,381) | (49,129) | (75,939) | (100,332) |
Income before income taxes | 9,362,111 | 6,084,741 | 14,333,977 | 9,096,598 |
Provision for income taxes | 3,467,219 | 2,347,873 | 5,371,083 | 3,447,611 |
Net income | 5,894,892 | 3,736,868 | 8,962,894 | 5,648,987 |
Basic net income per share: | ||||
Net income | $ 0.44 | $ 0.28 | $ 0.67 | $ 0.43 |
Basic weighted average common shares outstanding | 13,510,573 | 13,262,023 | 13,459,049 | 13,212,424 |
Diluted net income per share: | ||||
Net income | $ 0.40 | $ 0.26 | $ 0.62 | $ 0.39 |
Diluted weighted average common shares outstanding | 14,578,927 | 14,443,794 | 14,484,978 | 14,302,439 |
Net income | 5,894,892 | 3,736,868 | 8,962,894 | 5,648,987 |
Other comprehensive income | ||||
Foreign currency translation adjustment | 340,095 | (1,600,204) | (409,355) | (843,743) |
Comprehensive income | $ 6,234,987 | $ 2,136,664 | $ 8,553,539 | $ 4,805,244 |
Equity Incentive Plan
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Incentive Plan |
5.
Equity Incentive Plan
The
Company estimates the fair value of stock options and stock
appreciation rights using the Black-Scholes valuation model. Fair
value of restricted stock is measured by the grant-date price of
the Company’s shares. The fair value of each stock option
award during the three and six months ended June 30, 2013 and the
six months ended June 30, 2012 was estimated on the grant date
using the Black-Scholes option-pricing model with the following
assumptions:
The
Company recorded $365,367 and $788,326 of share-based compensation
expense for the three and six months ended June 30, 2013,
respectively, for equity compensation awards. The Company recorded
$312,563 and $633,073 of share-based compensation expense for the
three and six months ended June 30, 2012. The Company presents the
expenses related to stock-based compensation awards in the same
expense line items as cash compensation paid to the respective
employees.
At
the 2013 Annual Meeting of Stockholders on June 18, 2013, the
shareholders of the Company approved the amendment to the Anika
Therapeutics, Inc. Second Amended and Restated 2003 Stock Option
and Incentive Plan (the “2003 Plan”), which among other
things, increased the number of shares reserved for issuance under
the Company’s stock option and incentive plan by 650,000 to
3,800,000 shares.
There
were 20,000 stock options granted under the 2003 Plan during the
three months ended June 30, 2013. There were 374,500 stock options
granted under the Plan during the six months ended June 30, 2013.
There were no restricted stock units (“RSUs”) granted
to members of the Company’s Board of Directors during the
three months ended June 30, 2013. There were 13,800 RSUs granted to
members of the Company’s Board of Directors under the Plan
during the three months ended March 31, 2013. The stock options and
RSUs granted to employees and directors become exercisable or vest
ratably over four years from the date of grant.
As
of June 30, 2013, there was approximately $3.0 million of total
unrecognized compensation cost related to non-vested stock options,
stock appreciation rights (“SARs”), and restricted
stock awards (“RSAs”) granted under the Company’s
incentive plans. This cost is expected to be recognized over a
weighted-average period of 2.9 years.
The
total intrinsic value of stock options and SARs exercised during
the six-month periods ended June 30, 2013 and 2012 was $599,010 and
$1,241,759, respectively. Cash received from the exercise of stock
options during the three and six-month periods ended June 30, 2013
was $30,859 and $1,127,875, respectively. Cash received from the
exercise of stock options during the three and six-month periods
ended June 30, 2012 was $32,377 and $147,033,
respectively.
There
were approximately 1.9 million options and SARs outstanding under
the Company’s incentive plans at June 30, 2013 with a
weighted-average exercise price of $8.60 per share, an aggregate
intrinsic value of approximately $16.2 million, and a
weighted-average remaining contractual term of 6.27
years.
None
of the options or SARs outstanding at June 30, 2013 or 2012,
respectively, had cash-settlement features.
The
Company may satisfy the awards upon exercise, or upon fulfillment
of the vesting requirements for other equity-based awards, with
either authorized but unissued shares or shares reacquired by the
Company. Stock-based awards are granted with an exercise price
equal to the market price of the Company’s stock on the date
of grant. Awards contain service or performance conditions and
generally become exercisable ratably over one to four years and
have a ten year contractual term.
|
Intangible Assets and Goodwill (Tables)
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets | Intangible
assets as of June 30, 2013 and December 31, 2012 consist of the
following:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Changes in Carrying Value of Goodwill | Changes
in the carrying value of goodwill for the three and six months
ended June 30, 2013 were as follows:
|
Related Party
|
6 Months Ended | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
||||||||||||||||||||||
Related Party |
13. Related
Party
In
connection
with our acquisition of Anika S.r.l. on December 30, 2009, Fidia
Farmaceutici S.p.A. (“Fidia”) acquired ownership of
1,981,192 shares of the Company's common stock, of which 500,000
shares remain in escrow at June 30, 2013. As of June 30, 2013,
Fidia owns approximately 14.2% of the outstanding shares of the
Company.
Historically, Anika S.r.l. has relied on Fidia, its former parent
company, for several functional activities. In connection with
the purchase of Anika S.r.l., the Company has negotiated a lease
for approximately 26,000 square feet of office, laboratory and
warehouse space in Abano Terme, Italy, and a finished goods supply
agreement. As part of the acquisition, the Company, primarily
through Anika S.r.l., entered into a series of operating agreements
with Fidia as follows:
|
Accrued Expenses (Detail) (USD $)
|
Jun. 30, 2013
|
Dec. 31, 2012
|
---|---|---|
Schedule of Accrued Liabilities [Line Items] | ||
Payroll and benefits | $ 2,162,634 | $ 2,477,833 |
Professional fees | 469,991 | 642,853 |
Clinical trial costs | 67,767 | 102,414 |
Restructuring costs | 283,063 | 933,732 |
Other | 1,520,096 | 1,680,212 |
Total | $ 4,503,551 | $ 5,837,044 |
Segment and Geographic Information (Tables)
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2013
|
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Revenue by Product Group | Product
revenue by product group is as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue by Geographic Location and Percentage of Total Revenue | Total
revenue by geographic location and as a percentage of total
revenue, for the three and six months ended June 30, 2013 and 2012
are as follows:
|
Related Party (Tables)
|
6 Months Ended | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
||||||||||||||||||||||
Series of Operating Agreements | As part of the acquisition, the Company, primarily through Anika S.r.l., entered into a series of operating agreements with Fidia as follows:
|
Summary of Restructuring Accrual Activity (Detail) (USD $)
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Schedule Of Accrual Activity [Line Items] | |
December 31, 2012 | $ 933,732 |
Charges to Operations | |
Cash Proceeds, Disbursements | (659,110) |
Write Offs and Abandonments | |
Foreign Exchange Impact | 8,441 |
June 30, 2013 | 283,063 |
Employee Severance And Related Benefits
|
|
Schedule Of Accrual Activity [Line Items] | |
December 31, 2012 | 801,453 |
Charges to Operations | |
Cash Proceeds, Disbursements | (613,870) |
Write Offs and Abandonments | |
Foreign Exchange Impact | 8,422 |
June 30, 2013 | 196,005 |
Activity Termination and Facility Closure Costs
|
|
Schedule Of Accrual Activity [Line Items] | |
December 31, 2012 | 132,279 |
Charges to Operations | |
Cash Proceeds, Disbursements | (45,240) |
Write Offs and Abandonments | |
Foreign Exchange Impact | 19 |
June 30, 2013 | $ 87,058 |
Inventories (Detail) (USD $)
|
Jun. 30, 2013
|
Dec. 31, 2012
|
---|---|---|
Inventory [Line Items] | ||
Raw materials | $ 6,160,860 | $ 6,109,807 |
Work-in-process | 2,016,882 | 777,056 |
Finished goods | 2,180,056 | 1,396,609 |
Total | $ 10,357,798 | $ 8,283,472 |
Income Taxes - Additional Information (Detail) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Income Taxes [Line Items] | ||||
Income tax expense | $ 3,467,219 | $ 2,347,873 | $ 5,371,083 | $ 3,447,611 |
Effective income tax rate | 37.00% | 38.60% | 37.50% | 37.90% |
Federal | Minimum
|
||||
Income Taxes [Line Items] | ||||
Tax years subject to examination | 2009 | |||
Federal | Maximum
|
||||
Income Taxes [Line Items] | ||||
Tax years subject to examination | 2012 | |||
State | Minimum
|
||||
Income Taxes [Line Items] | ||||
Tax years subject to examination | 2009 | |||
State | Maximum
|
||||
Income Taxes [Line Items] | ||||
Tax years subject to examination | 2012 | |||
Italy | Minimum
|
||||
Income Taxes [Line Items] | ||||
Tax years subject to examination | 2009 | |||
Italy | Maximum
|
||||
Income Taxes [Line Items] | ||||
Tax years subject to examination | 2012 |
Equity Incentive Plan - Additional Information (Detail) (USD $)
|
1 Months Ended | 3 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 18, 2013
|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
Stock Awards
|
Jun. 30, 2013
Stock Awards
|
Jun. 30, 2013
Stock Awards
Minimum
|
Jun. 30, 2013
Stock Awards
Minimum
|
Jun. 30, 2013
Stock Awards
Maximum
|
Jun. 30, 2013
Stock Awards
Maximum
|
Jun. 30, 2013
Restricted Stock Units (RSUs)
|
Mar. 31, 2013
Restricted Stock Units (RSUs)
|
Jun. 30, 2013
Stock Options and Restricted Stock
|
Jun. 30, 2013
Stock Options and Restricted Stock
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Share based compensation expense | $ 365,367 | $ 312,563 | $ 788,326 | $ 633,073 | |||||||||||
Increase in shares reserved for grant under stock option and incentive plan | 650,000 | ||||||||||||||
Shares reserved for grant under stock option and incentive plan | 3,800,000 | ||||||||||||||
Stock options granted to employees | 20,000 | 374,500 | |||||||||||||
Restricted stock units granted to Board of Directors | 0 | 13,800 | |||||||||||||
Stock option and incentive plan, vesting period | 1 year | 1 year | 4 years | 4 years | 4 years | 4 years | |||||||||
Unrecognized stock-based compensation cost | 3,000,000 | 3,000,000 | |||||||||||||
Unrecognized stock-based compensation cost, weighted-average recognition period | 2 years 10 months 24 days | ||||||||||||||
Intrinsic value of stock options and SARs | 599,010 | 1,241,759 | |||||||||||||
Cash received from exercise of stock options | 30,859 | 32,377 | 1,127,875 | 147,033 | |||||||||||
Options and SARs outstanding | 1,900,000 | 1,900,000 | |||||||||||||
Weighted average exercise price per share | $ 8.60 | $ 8.60 | |||||||||||||
Intrinsic value of Options and SARs | $ 16,200,000 | $ 16,200,000 | |||||||||||||
Weighted average remaining contractual term | 6 years 3 months 7 days | 6 years 3 months 7 days | |||||||||||||
Stock based awards, contractual term | 10 years | 10 years |
Revenue by Product Group (Detail) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Revenue from External Customer [Line Items] | ||||
Product revenue | $ 20,067,407 | $ 18,882,277 | $ 34,561,896 | $ 32,495,605 |
Orthobiologics
|
||||
Revenue from External Customer [Line Items] | ||||
Product revenue | 16,506,226 | 10,903,364 | 27,789,773 | 21,020,209 |
Dermal
|
||||
Revenue from External Customer [Line Items] | ||||
Product revenue | 557,059 | 155,735 | 798,643 | 657,051 |
Surgical
|
||||
Revenue from External Customer [Line Items] | ||||
Product revenue | 1,830,022 | 1,464,505 | 2,818,886 | 2,448,133 |
Ophthalmic
|
||||
Revenue from External Customer [Line Items] | ||||
Product revenue | 464,340 | 5,299,732 | 1,392,798 | 6,623,726 |
Veterinary
|
||||
Revenue from External Customer [Line Items] | ||||
Product revenue | $ 709,760 | $ 1,058,941 | $ 1,761,796 | $ 1,746,486 |
Accrued Expenses (Tables)
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses | Accrued
expenses
consist of the following:
|
Nature of Business
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Nature of Business |
1. Nature
of Business
Anika
Therapeutics, Inc. (together with its subsidiaries,
“Anika,” the “Company,” “we,”
“us,” or “our”) develops, manufactures and
commercializes therapeutic products for tissue protection, healing,
and repair. These products are based on hyaluronic acid
(“HA”), a naturally occurring, biocompatible polymer
found throughout the body. Due to its unique biophysical and
biochemical properties, HA plays an important role in a number of
physiological functions such as the protection and lubrication of
soft tissues and joints, the maintenance of the structural
integrity of tissues, and the transport of molecules to and within
cells.
The
Company is subject to risks common to companies in the
biotechnology and medical device industries including, but not
limited to, development by the Company or its competitors of new
technological innovations, dependence on key personnel, protection
of proprietary technology, commercialization of existing and new
products, and compliance with the U.S. Food and Drug Administration
(“FDA”) and foreign regulations and approval
requirements as well as the ability to grow the Company’s
business.
|
Recent Accounting Pronouncements Issued or Adopted
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Recent Accounting Pronouncements Issued or Adopted |
3.
Recent Accounting Pronouncements Issued or Adopted
In
February 2013, the FASB issued Accounting Standards Update
(“ASU”) No. 2013-02, Comprehensive Income (Topic
220): Reporting of Amounts Reclassified Out of Accumulated Other
Comprehensive Income. The provisions of ASU 2013-02 are
effective for annual and interim periods beginning after December
15, 2012. The objective of this update is to improve the reporting
of reclassifications out of accumulated other comprehensive income.
The amendments in this update seek to attain that objective by
requiring an entity to report the effect of significant
reclassifications out of accumulated other comprehensive income on
the respective line items in net income if the amount being
reclassified is required under U.S. generally accepted accounting
principles to be reclassified in its entirety to net
income. The adoption of
this amendment did not have a material impact on our consolidated
financial position, results of operations, or cash
flows.
In
March 2013, the FASB issued ASU No. 2013-05, Foreign Currency Matters
(Topic 830): Parent’s Accounting for the Cumulative
Translation Adjustment upon Derecognition of Certain Subsidiaries
or Groups of Assets within a Foreign Entity or of an Investment in
a Foreign Entity. The provisions of
ASU 2013-05 are effective for annual and interim periods beginning
after December 15, 2013. The objective of the amendments in this
update is to resolve the diversity in practice about whether
Subtopic 810-10, Consolidation—Overall,
or Subtopic 830-30, Foreign Currency
Matters—Translation of Financial Statements, applies
to the release of the cumulative translation adjustment into net
income when a parent either sells a part or all of its investment
in a
foreign entity or no longer holds a controlling financial interest
in a subsidiary or group of assets that is a nonprofit activity or
a business (other than a sale of in substance real estate or
conveyance of oil and gas mineral rights) within a foreign
entity. The adoption of this amendment will not have a material
impact on our consolidated financial position, results of
operations, or cash flows.
|
Earnings Per Share
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
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Earnings Per Share |
6.
Earnings Per Share
The
Company reports earnings per share in accordance with ASC 260,
Earnings Per
Share, which establishes standards for computing and
presenting earnings per share. Basic earnings per share is computed
by dividing net income available to common shareholders by the
weighted average number of common shares outstanding during the
period. Diluted earnings per share is computed by dividing net
income available to common shareholders by the weighted average
number of common shares outstanding and the number of dilutive
potential common share equivalents during the period. Under the
treasury stock method, unexercised “in-the-money” stock
options are assumed to be exercised at the beginning of the period
or at issuance, if later. The assumed proceeds are then used to
purchase common shares at the average market price during the
period.
Basic
and diluted earnings per share for the three and six months ended
June 30, 2013 and 2012 are as follows:
In
connection with the acquisition of Anika Therapeutics S.r.l.
(“Anika S.r.l.”) on December 30, 2009, the Company
issued 1,981,192 shares of its common stock of which 500,000 of
these shares remain in escrow at June 30, 2013. These 500,000
shares are included in the diluted potential common shares but are
excluded from the basic earnings per share
calculation.
Equity
awards of 469,618 and 459,969 shares were outstanding for the three
and six months ended June 30, 2013, respectively, but were not
included in the computation of diluted earnings per share because
the awards’ impact on earnings per share was
anti-dilutive. Equity awards of 99,245 and 126,124 shares were
outstanding for the three and six months ended June 30, 2012,
respectively, but were not included in the computation of diluted
earnings per share because the awards’ impact on earnings per
share was anti-dilutive.
|
Fair Value Measurements
|
6 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
||||||||||
Fair Value Measurements |
4.
Fair Value Measurements
We measure certain assets and liabilities, such as
fixed income investments, at fair value based upon exit price,
representing the amount that would be received on the sale of an
asset or paid to transfer a liability, as the case may be, in an
orderly transaction between market participants. As such, fair
value may be based on assumptions that market participants would
use in pricing an asset or liability. To increase the comparability
of fair value measurements, the following hierarchical levels of
inputs to valuation methodologies are used:
Cash equivalents in money market accounts measured
and recorded at fair value on a recurring basis was $34,264,268 at
June 30, 2013 and December 31, 2012, and were classified as Level 1
instruments.
|
Related Party - Additional Information (Detail)
|
1 Months Ended | |
---|---|---|
Dec. 30, 2009
|
Jun. 30, 2013
|
|
Related Party Transaction [Line Items] | ||
Square footage of leased space | 26,000 | |
Anika Therapeutics S.r.l.
|
||
Related Party Transaction [Line Items] | ||
Issuance of common stock in connection with acquisition | 1,981,192 | |
Shares remain in escrow | 500,000 | |
Fidia Farmaceutici Spa
|
||
Related Party Transaction [Line Items] | ||
Percentage of ownership interests | 14.20% |
Restructuring Charges (Tables)
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Restructuring Accrual Activity | The
following table summarizes restructuring accrual activity for the
six months ended June 30, 2013:
|
Basic and Diluted Earnings Per Share (Detail)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Schedule of Earnings Per Share, Basic and Diluted, by Common Class [Line Items] | ||||
Shares used in the calculation of Basic earnings per share | 13,510,573 | 13,262,023 | 13,459,049 | 13,212,424 |
Effect of dilutive securities: | ||||
Stock options, SARs, RSAs, and shares held in escrow | 1,068,354 | 1,181,771 | 1,025,929 | 1,090,015 |
Diluted shares used in the calculation of earnings per share | 14,578,927 | 14,443,794 | 14,484,978 | 14,302,439 |
Changes in Carrying Value of Goodwill (Detail) (USD $)
|
3 Months Ended | 6 Months Ended |
---|---|---|
Jun. 30, 2013
|
Jun. 30, 2013
|
|
Goodwill [Line Items] | ||
Balance, beginning | $ 8,792,165 | $ 9,065,891 |
Effect of foreign currency adjustments | 131,032 | (142,694) |
Balance, ending | $ 8,923,197 | $ 8,923,197 |