Anika Therapeutics
Anika Therapeutics, Inc. (Form: 10-Q, Received: 11/06/2014 06:04:50)
 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


 

FORM 10-Q

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2014

 

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                    to

 


 

Commission File Number 000-21326

 

Anika Therapeutics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Massachusetts 04-3145961
(State or Other Jurisdiction of (I.R.S. Employer Identification No.)
Incorporation or Organization)  
   
32 Wiggins Avenue, Bedford, Massachusetts 01730
(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (781) 457-9000

 

Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report: N/A

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x       No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes x No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer  o   Accelerated filer  x  

Non-accelerated filer  o

(Do not check if a smaller

reporting company)

 

Smaller reporting

company  o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)

Yes  o     No  x

 

As of October 31, 2014 there were 14,504,014 outstanding shares of Common Stock, par value $.01 per share.

 

 
 

 

PART I: FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS

 

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(unaudited)

 

ASSETS  

September 30,

2014

 

December 31,

2013

Current assets:                
Cash and cash equivalents   $ 71,772,194     $ 63,333,160  
Marketable securities     19,999,600       -  
Accounts receivable, net of reserves of $546,455 and $593,023 at September 30, 2014 and December 31, 2013, respectively     20,170,095       18,736,845  
Inventories     13,582,456       10,996,785  
Prepaid income taxes     1,343,576       -  
Current portion deferred income taxes     659,040       659,040  
Prepaid expenses and other     1,128,693       865,957  
Total current assets     128,655,654       94,591,787  
Property and equipment, at cost     53,379,965       52,413,423  
Less: accumulated depreciation     (21,343,322 )     (19,474,712 )
      32,036,643       32,938,711  
Long-term deposits and other     69,054       69,080  
Intangible assets, net     16,033,944       18,998,409  
Goodwill     8,702,295       9,443,894  
Total assets   $ 185,497,590     $ 156,041,881  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable   $ 1,167,545     $ 2,793,911  
Accrued expenses     5,253,693       5,537,881  
Deferred revenue     12,885       180,433  
Income taxes payable     -       770,276  
Total current liabilities     6,434,123       9,282,501  
Other long-term liabilities     948,858       1,133,544  
Long-term deferred revenue     56,573       2,054,941  
Deferred tax liability     8,353,531       7,936,864  
Commitments and contingencies (Note 10)                
Stockholders’ equity:                
Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively     -       -  
Common stock, $.01 par value; 30,000,000 shares authorized, 14,800,453 and 14,289,308 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively     148,004       142,893  
Additional paid-in-capital     76,064,383       70,606,031  
Accumulated other comprehensive loss     (3,595,487 )     (1,699,095 )
Retained earnings     97,087,605       66,584,202  
Total stockholders’ equity     169,704,505       135,634,031  
Total Liabilities and Stockholders’ Equity   $ 185,497,590     $ 156,041,881  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

2
 

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income

(unaudited)

 

    Three Months Ended September 30,   Nine Months Ended September 30,
      2014       2013       2014       2013  
Product revenue   $ 21,975,312     $ 17,023,346     $ 57,593,873     $ 51,585,242  
Licensing, milestone and contract revenue     80,111       731,092       24,746,497       2,244,584  
Total revenue     22,055,423       17,754,438       82,340,370       53,829,826  
                                 
Operating expenses:                                
Cost of product revenue     5,724,800       5,377,568       15,418,732       16,530,070  
Research & development     1,999,867       1,618,012       6,160,740       5,029,974  
Selling, general & administrative     4,044,538       3,188,669       11,401,399       10,536,462  
Restructuring credits     -       (196,084 )     -       (442,869 )
Total operating expenses     11,769,205       9,988,165       32,980,871       31,653,637  
Income from operations     10,286,218       7,766,273       49,359,499       22,176,189  
Interest income (expense), net     9,937       (32,816 )     16,339       (108,755 )
Income before income taxes     10,296,155       7,733,457       49,375,838       22,067,434  
Provision for income taxes     4,125,355       2,776,199       18,872,435       8,147,282  
Net income   $ 6,170,800     $ 4,957,258     $ 30,503,403     $ 13,920,152  
                                 
Basic net income per share:                                
Net income   $ 0.42     $ 0.36     $ 2.09     $ 1.03  
Basic weighted average common shares outstanding     14,758,781       13,682,449       14,626,933       13,534,334  
Diluted net income per share:                                
Net income   $ 0.40     $ 0.33     $ 1.97     $ 0.95  
Diluted weighted average common shares outstanding     15,434,875       14,958,965       15,469,237       14,673,879  
                                 
Net income   $ 6,170,800     $ 4,957,258     $ 30,503,403     $ 13,920,152  
Other comprehensive income (loss):                                
Unrealized gain on securities, net of tax     431       -       431       -  
Foreign currency translation adjustment     (1,679,968 )     916,474       (1,896,823 )     507,119  
Total other comprehensive income (loss)     (1,679,537 )     916,474       (1,896,392 )     507,119  
Comprehensive income   $ 4,491,263     $ 5,873,732     $ 28,607,011     $ 14,427,271  

  

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3
 

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

 (unaudited) 

 

    Nine Months Ended September 30,
    2014   2013
Cash flows from operating activities:                
Net income   $ 30,503,403     $ 13,920,152  
Adjustments to reconcile net income to net cash provided by operating activities:                
Depreciation and amortization     3,576,441       3,579,474  
Stock-based compensation expense     1,196,361       1,156,929  
Provision for doubtful accounts     -       24,098  
Provision for inventory     220,207       165,803  
Gain on sale of assets     -       (442,341 )
Tax benefit from exercise of stock options     (9,236,708 )     (764,181 )
Changes in operating assets and liabilities:                
Accounts receivable     (1,840,407 )     4,667,839  
Inventories     (2,923,628 )     (3,430,655 )
Prepaid expenses, other current and long-term assets     183,481       531,449  
Long-term deposits and other     -       25,497  
Accounts payable     (992,822 )     124,679  
Accrued expenses     (989,291 )     (642,430 )
Deferred revenue     (2,078,543 )     (2,150,000 )
Income taxes     7,771,001       766,598  
Other long-term liabilities     (167,123 )     (373,712 )
Net cash provided by operating activities     25,222,372       17,159,199  
                 
Cash flows from investing activities:                
Purchase of marketable securities     (19,999,169 )     -  
Proceeds from sale of assets     -       530,865  
Purchase of property and equipment     (920,132 )     (235,803 )
Net cash provided by (used in) investing activities     (20,919,301 )     295,062  
                 
Cash flows from financing activities:                
Proceeds from exercise of stock options     1,379,294       2,932,649  
Tax benefit from exercise of stock options     9,236,708       764,181  
Minimum tax withholding on share based awards     (6,348,900 )     -  
Principal payments on debt     -       (1,200,000 )
Net cash provided by financing activities     4,267,102       2,496,830  
                 
Exchange rate impact on cash     (131,139 )     36,870  
                 
Increase in cash and cash equivalents     8,439,034       19,987,961  
Cash and cash equivalents at beginning of period     63,333,160       44,067,477  
Cash and cash equivalents at end of period   $ 71,772,194     $ 64,055,438  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4
 

ANIKA THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

( unaudited )

 

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 information and 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.

 

2. Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and in accordance with accounting principles generally accepted in the United States (“U.S.”). The financial statements include the accounts of Anika Therapeutics, Inc. and its subsidiaries. Inter-company transactions and balances have been eliminated. The year-end consolidated balance sheet is derived from our audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the U.S. In the opinion of management, these unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary to fairly state the condensed consolidated financial position of the Company as of September 30, 2014, the results of its operations for the three and nine-month periods ended September 30, 2014 and 2013, and cash flows for the nine-month periods ended September 30, 2014 and 2013.

 

The accompanying unaudited condensed consolidated financial statements and related notes should be read in conjunction with the Company’s annual financial statements filed with its Annual Report on Form 10-K for the year ended December 31, 2013. The results of operations for the three and nine-month periods ended September 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014. Certain prior period amounts have been reclassified to conform to the current period presentation. There was no impact on operating income.

 

A revision was made on the condensed consolidated statement of cash flows for the six months ended June 30, 2014 to correctly reflect the tax benefit from exercise of certain equity awards. This revision has an impact on the statement of cash flows as a reduction of cash provided by operating activities of $2.5 million with a corresponding increase to cash provided by financing activities related to the tax benefit from exercise of stock options for the six months ended June 30, 2014 of the same amount. This revision has no impact on the statement of operations or cash position. The revision to the condensed consolidated statement of cash flows represents amounts that are not deemed to be material, individually or in the aggregate, to the prior period condensed consolidated financial statements.

 

3.

Marketable Securities

 

    September 30, 2014
   

Amortized

Cost

 

Unrealized

Gains, Net of Tax

 

Unrealized

Losses, Net of Tax

 

Fair

Value

United States Treasury securities   $ 14,999,169     $ 699     $ (268 )   $ 14,999,600  
Bank certificates of deposit     5,000,000       -       -       5,000,000  
    $ 19,999,169     $ 699     $ (268 )   $ 19,999,600  

 

The Company considers securities with maturities of three months or less from the purchase date to be cash equivalents. Interest is recorded when earned. All of the Company’s investments are classified as available-for-sale and are carried at fair value with unrealized gains and losses recorded as a component of accumulated other comprehensive income, net of related income taxes.

 

4. Fair Value Measurements

 

Fair value is an exit price, representing the amount that would be received from the sale of an asset or paid to transfer a liability in an orderly transaction between market participants based on assumptions that market participants would use in pricing an asset or liability. As a basis for classifying the fair value measurements, a three-tier fair value hierarchy, which classifies the fair value measurements based on the inputs used in measuring fair value, was established as follows: (Level 1) observable inputs such as quoted prices in active markets for identical assets or liabilities; (Level 2) significant other observable inputs that are observable either directly or indirectly; and (Level 3) significant unobservable inputs in which there is little or no market data, which requires the Company to develop its own assumptions. This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. On a recurring basis, the Company records its marketable securities at fair value.

 

5
 

The Company’s investments are all classified within Level 1 and Level 2 of the fair value hierarchy. The Company’s investments classified within Level 1 of the fair value hierarchy are valued using quoted market prices. The Company’s investments classified within Level 2 of the fair value hierarchy are valued based on matrix pricing compiled by third party pricing vendors, using observable market inputs such as interest rates, yield curves, and credit risk.

 

The fair value hierarchy of the Company’s cash equivalents and marketable securities at fair value is as follows:

 

       

Fair Value Measurements at Reporting

Date Using

    September 30, 2014  

Quoted Prices in

Active Markets

for Identical Assets

(Level 1)

 

Significant Other

Observable Inputs

(Level 2)

 

Significant

Unobservable

Inputs

(Level 3)

Money market funds   $ 49,285,168     $ -     $ 49,285,168     $ -  
                                 
Marketable securities:                                
United States Treasury securities     14,999,600       14,999,600       -       -  
Bank certificates of deposit     5,000,000       -       5,000,000       -  
Total marketable securities   $ 19,999,600     $ 14,999,600     $ 5,000,000     $ -  

 

        Fair Value Measurements at Reporting
Date Using
    December 31, 2013   Quoted Prices in
Active Markets
 for Identical Assets 
 (Level 1)
  Significant Other
Observable Inputs 
(Level 2)
 

Significant

Unobservable

Inputs

(Level 3)

Money market funds   $ 34,266,501     $ -     $ 34,266,501     $ -  

 

 

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 nine-month periods ended September 30, 2014 and 2013, respectively, was estimated on the grant date using the Black-Scholes option-pricing model with the following assumptions:

 

6
 
 

Three Months Ended

September 30,

  2014   2013
Risk free interest rate 1.30% - 1.39%     -
Expected volatility   53.28%     -
Expected lives (years)   4     -
Expected dividend yield   0.00%     -

 

 

Nine Months Ended

September 30,

  2014   2013
Risk free interest rate 1.16% - 1.39%   0.61% - 0.70%
Expected volatility   53.28%     57.60%
Expected lives (years)   4     4
Expected dividend yield   0.00%     0.00%

 

The Company recorded $390,578 and $368,603 of share-based compensation expense for the three-month periods ended September 30, 2014 and 2013, respectively, for equity compensation awards. The Company recorded $1,196,361 and $1,156,929 of share-based compensation expense for the nine-month periods ended September 30, 2014 and 2013, respectively, for equity compensation awards. The Company presents the expenses related to stock-based compensation awards in the same expense line items as cash compensation paid to the respective recipients.

 

There were 7,000 and 139,240 stock options granted under the Plan during the three and nine-month periods ended September 30, 2014, respectively. There were no Restricted Stock Awards (“RSAs”) or Restricted Stock Units (“RSUs”) granted under the Plan during the three-month period ended September 30, 2014. There were 9,365 RSUs granted to members of the Company’s Board of Directors under the Plan during the nine-month period ended September 30, 2014. There were 30,700 RSAs granted to Company employees under the Plan during the nine-month period ended September 30, 2014. The stock options, RSAs and RSUs granted to employees and directors become exercisable or vest ratably over four years from the date of grant.

 

A portion of the stock options granted during the nine-month period ended September 30, 2014 contained certain performance features, as compared to established targets, in addition to time-based vesting conditions. The compensation costs associated with these grants was estimated using the Black-Scholes valuation method factored for the estimated probability of achieving the performance goals.

 

As of September 30, 2014, there was approximately $4.2 million of total unrecognized compensation cost related to non-vested stock options, stock appreciation rights (“SARs”), RSAs and RSUs granted under the Company’s incentive Plans. This cost is expected to be recognized over a weighted-average period of 3.0 years.

 

The total intrinsic value of stock options and SARs exercised during the nine-month periods ended September 30, 2014 and 2013 was $25,473,089 and $4,095,833, respectively. Cash received from the exercise of stock options during the three and nine-month periods ended September 30, 2014 and 2013 were $17,513 and $1,379,294, and $1,804,773 and $2,932,649, respectively. During the second quarter of 2014, the Company acquired and subsequently retired 133,774 common shares related to an employee SARs exercise, to meet minimum statutory tax withholding requirements.

 

There were 936,097 options and SARs outstanding under the Company’s incentive Plans as of September 30, 2014 with a weighted-average exercise price of $13.54 per share, an aggregate intrinsic value of approximately $21.8 million, and a weighted-average remaining contractual term of 6.8 years. None of the options or SARs outstanding at September 30, 2014 or 2013, 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 containing service conditions generally become exercisable ratably over one to four years, have a ten year contractual term and sometimes contain performance conditions. 

 

7
 
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 nine-month periods ended September 30, 2014 and 2013 are as follows: 

 

    Three Months Ended September 30,   Nine Months Ended September 30,
    2014   2013   2014   2013
Shares used in the calculation of basic earnings per share     14,758,781       13,682,449       14,626,933       13,534,334  
Effect of dilutive securities:                                
Stock options, SARs, and RSAs     676,094       1,276,516       842,304       1,139,545  
Diluted shares used in the calculation of earnings per share     15,434,875       14,958,965       15,469,237       14,673,879  

 

Equity awards of 122,967 and 118,725 shares were outstanding for the three and nine-month periods ended September 30, 2014, respectively, and were not included in the computation of diluted earnings per share because the awards’ impact on earnings per share was anti-dilutive. There were no anti-dilutive equity awards for the three month period ended September 30, 2013. Equity awards of 88,278 shares were outstanding for the nine-month period ended September 30, 2013, and were not included in the computation of diluted earnings per share because the awards’ impact on earnings per share was anti-dilutive.   

 

7. Inventories

 

Inventories consist of the following:

 

   

September 30,

2014

 

December 31,

2013

Raw materials   $ 6,843,441     $ 5,926,030  
Work-in-process     2,325,667       2,308,233  
Finished goods     4,413,348       2,762,522  
Total   $ 13,582,456     $ 10,996,785  

 

Inventories are stated at the lower of cost or market, with cost being determined using the first-in, first-out method. Work-in-process and finished goods inventories include materials, labor, and manufacturing overhead.

 

8.   Intangible Assets and Goodwill

 

In connection with the acquisition of Anika Therapeutics S.r.l. (“Anika S.r.l.”), the Company acquired various intangible assets and goodwill. The Company evaluated the various intangible assets and related cash flows from these intangible assets, as well as the useful lives and amortization methods related to these intangible assets. The in-process research and development (“IPR&D”) intangible assets initially have indefinite lives and are reviewed periodically to assess the project status, valuation, and disposition, including write-off(s) for abandoned projects. Until such determination is made, they are not amortized. 

 

The Company reviews its long-lived assets for impairment at least annually. Additionally, the Company will initiate a review for impairment if events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of the assets are no longer appropriate. Each impairment test will be based on a comparison of the undiscounted cash flows to the recorded value of the asset. If impairment is indicated, the asset is written down to its estimated fair value.

 

8
 

Intangible assets as of September 30, 2014 and December 31, 2013 consist of the following:

 

        September 30, 2014   December 31, 2013
    Gross Value  

Currency

Translation

Adjustment

 

Accumulated

Amortization

 

Net Book

Value

 

Net Book

Value

  Useful Life
Developed technology   $ 16,700,000     $ (1,828,214 )   $ (4,779,123 )   $ 10,092,663     $ 11,753,003       15  
In-process research & development     5,502,686       (638,426 )     -       4,864,260       5,286,127       Indefinite  
Distributor relationships     4,700,000       (440,953 )     (4,084,944 )     174,103       863,655       5  
Patents     1,000,000       (107,910 )     (271,208 )     620,882       719,574       16  
Elevess trade name     1,000,000       -       (717,964 )     282,036       376,050       9  
Total   $ 28,902,686     $ (3,015,503 )   $ (9,853,239 )   $ 16,033,944     $ 18,998,409          

 

The aggregate amortization expense related to intangible assets was $518,699 and $521,387 for the three-month periods ended September 30, 2014 and 2013, respectively. The aggregate amortization expense related to intangible assets was $1,593,260 and $1,555,796 for the nine-month periods ended September 30, 2014 and 2013, respectively.

 

Changes in the carrying value of goodwill for the three and nine-month periods ended September 30, 2014 were as follows:

 

Goodwill  

Three

Months Ended

September 30,

2014

 

Nine

Months Ended

September 30,

2014

                 
Balance, beginning   $ 9,360,884     $ 9,443,894  
Effect of foreign currency adjustments     (658,589 )     (741,599 )
Balance, ending   $ 8,702,295     $ 8,702,295  

 

9.

Accrued Expenses

 

Accrued expenses consist of the following:

 

   

September 30,

2014

 

December 31,

2013

Labor and related expenses   $ 2,842,234     $ 2,870,147  
Clinical trial costs     962,031       882,651  
Professional fees     382,423       383,231  
Research grants     562,558       610,498  
Restructuring costs     11,909       24,638  
Other     492,538       766,716  
Total   $ 5,253,693     $ 5,537,881  

 

10. Commitments and Contingencies

 

In certain of its contracts, the Company warrants to its customers that the products it manufactures conform to the product specifications as in effect at the time of delivery of the product. The Company may also warrant that the products it manufactures do not infringe, violate or breach any patent or intellectual property rights, trade secret or other proprietary information of any third party. On occasion, the Company contractually indemnifies its customers against any and all losses arising out of, or in any way connected with, any claim or claims of breach of its warranties or any actual or alleged defect in any product caused by the negligence or acts or omissions of the Company. The Company maintains a products liability insurance policy that limits its exposure. Based on the Company’s historical activity in combination with its insurance policy coverage, the Company believes the estimated fair value of these indemnification agreements is minimal. The Company has no accrued warranties and has no history of claims paid.

 

On July 7, 2010, Genzyme Corporation filed a complaint against the Company in the United States District Court for the District of Massachusetts seeking unspecified damages and equitable relief. The complaint alleged that the Company infringed U.S. Patent No. 5,143,724 by manufacturing MONOVISC® in the United States for sale outside the United States and would infringe U.S. Patent Nos. 5,143,724 and 5,399,351 if the Company manufactured and sold MONOVISC in the United States. On March 7, 2014, Genzyme and the Company filed a joint motion to lift the stay in Genzyme’s lawsuit against the Company and to dismiss with prejudice all of Genzyme’s claims. On March 10, 2014, the District Court granted the motion to dismiss with prejudice all of Genzyme’s claims against the Company and the case was terminated.

 

9
 

The Company is also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these other legal proceedings to have a material adverse effect on its financial position, results of operations or cash flow. 

 

11. Mitek Monovisc Agreement

 

In December 2011, the Company entered into a fifteen-year licensing agreement (the “Mitek MONOVISC Agreement”) with DePuy Synthes Mitek Sports Medicine, a division of DePuy Orthopaedics, Inc., to exclusively market MONOVISC in the U.S. The Company received an upfront payment of $2,500,000 in December 2011. This non-refundable upfront payment did not have standalone value without Anika’s completion of development obligations which included obtaining regulatory approval of the product and resolving the patent litigation. As a result, we recognized the upfront payment over the development obligation period. During the first quarter of 2014, the Company received FDA approval of MONOVISC and resolved the patent lawsuit with Genzyme Corporation. As a result of the full delivery of its development obligations under this agreement, the Company recognized approximately $2,200,000 which represents the remaining balance of deferred revenue relating to the initial $2,500,000 payment in accordance with current generally accepted principles on revenue recognition. In the first quarter of 2014, the Company also received a milestone payment of $17,500,000 as a result of achieving FDA approval for MONOVISC and resolving the patent litigation with Genzyme. This milestone payment was fully recognized as revenue during the three months ended March 31, 2014. On April 15, 2014 the first U.S. commercial sale of MONOVISC was made by our commercial partner, DePuy Synthes Mitek Sports Medicine. Under the terms of the Mitek MONOVISC Agreement, the Company earned and collected a milestone payment of $5 million, which was fully recognized as revenue in the second quarter of 2014.

 

12. Income Taxes

 

Provisions for income taxes were $4,125,355 and $18,872,435 for the three and nine-month periods ended September 30, 2014, respectively, based on effective tax rates of 40% and 38%. Provisions for income taxes were $2,776,199 and $8,147,282 for the three and nine-month periods ended September 30, 2013, respectively, based on effective tax rates of 36% and 37%, respectively. The increase in income taxes over the three-month period ended September 30, 2014 was primarily due to increased net income. The increase in income taxes over the nine-month period ended September 30, 2014 was primarily due to increased net income, which reflected $24,652,778 in milestone and contract revenue associated with our U.S. license agreement for MONOVISC. See the previous discussion under Note 11. The increase in the effective tax rate for each of the periods ended 2014, as compared to the same periods ended in 2013, was driven primarily by the unavailability of the federal R&D tax credit in 2014, due to its expiration on December 31, 2013, and a relative decrease to our estimated production activities deduction.

 

The Company files income tax returns in the U.S. on a federal basis, 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. Our filings from 2011 through the present tax year remain subject to examination by the IRS and other taxing authorities for U.S. federal and state tax purposes. Our filings from 2009 through the present tax year 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. We have concluded that the positive evidence outweighs the negative evidence and, thus, those deferred tax assets are realizable on a “more likely than not” basis. As such, we have not recorded a valuation allowance at September 30, 2014 or December 31, 2013. 

 

 13.

 Segment and Geographic Information

 

The Company has one reportable operating segment, the results of which are disclosed in the accompanying unaudited condensed consolidated financial statements.

 

10
 

Product revenue by product group is as follows:

 

    Three Months Ended September 30,   Nine Months Ended September 30,
    2014   2013   2014   2013
  Orthobiologics     $ 18,899,873     $ 12,830,566     $ 48,750,277     $ 40,620,339  
  Dermal       401,355       267,766       938,966       1,066,409  
  Surgical       1,452,946       1,136,248       4,581,496       3,955,134  
  Ophthalmic       366,138       1,425,609       938,134       2,818,407  
  Veterinary       855,000       1,363,157       2,385,000       3,124,953  
        $ 21,975,312     $ 17,023,346     $ 57,593,873     $ 51,585,242  

 

Total revenue by geographic location and as a percentage of overall total revenue, for the three and nine-month periods ended September 30, 2014 and 2013 are as follows;

 

    Three Months Ended September 30,
    2014   2013
   

Total

Revenue

 

Percentage of

Revenue

 

Total

Revenue

 

Percentage of

Revenue

Geographic Location:                                
United States   $ 18,455,167       84 %   $ 14,485,821       82 %
Europe     1,784,414       8 %     1,656,656       9 %
Other     1,815,842       8 %     1,611,961       9 %
Total   $ 22,055,423       100 %   $ 17,754,438       100 %

 

    Nine Months Ended September 30,
    2014   2013
   

Total

Revenue

 

Percentage of

Revenue

 

Total

Revenue

 

Percentage of

Revenue

Geographic Location:                                
United States   $ 72,935,722       89 %   $ 42,251,336       78 %
Europe     5,274,071       6 %     5,226,619       10 %
Other     4,130,577       5 %     6,351,871       12 %
Total   $ 82,340,370       100 %   $ 53,829,826       100 %

 

14. Restructuring Credits

 

In December 2012, the Company announced the closure of its tissue engineering facility in Abano Terme, Italy due to the Company’s inability to meet strict regulatory standards established by the European Medicines Agency (“EMA”) for Advanced Therapy Medicinal Products, which became effective on January 1, 2013. The restructuring plan involved a workforce reduction as well as associated asset abandonments. The Company recorded restructuring and impairment charges in the fourth quarter of 2012 of approximately $2.5 million. Of the total restructuring and impairment charges related to the tissue engineering operation, approximately $1.2 million was related to the non-cash termination and related impairment of an IPR&D project, $0.3 million was related to the disposal of property and equipment, and $0.1 million was related to the disposal of inventory. We completed the restructuring plan and related activities in 2013. Certain previously impaired and written-off equipment was sold, resulting in restructuring credits of $196,084 and $442,869 in the three and nine months ended September 30, 2013, respectively.

 

11
 

The following table summarizes restructuring accrual activity for the nine-period ended September 30, 2014:

 

    Restructuring Accrual
   

Employee

Severance and

Related Benefits

 

Activity

Termination and

Facility Closure

Costs

  Total
December 31, 2013   $ 21,709     $ 2,929     $ 24,638  
Cash Proceeds (Disbursements)     (10,130 )     (1,425 )     (11,555 )
Foreign Exchange Impact     (1,050 )     (124 )     (1,174 )
September 30, 2014   $ 10,529     $ 1,380     $ 11,909  

 

15. New Accounting Standards

 

In June 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update ("ASU") No. 2014-12, “Compensation - Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide that a Performance Target Could be Achieved after the Requisite Service Period, which requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. Thus, the performance target should not be reflected in estimating the grant date fair value of the award. This update further clarifies that compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. The new guidance is effective for the Company beginning January 1, 2016. Early adoption is permitted. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.

 

In May 2014, the FASB issued ASU No. 2014-09, "Revenue from Contracts with Customers." ASU 2014-09 supersedes the revenue recognition requirements in "Topic 605, Revenue Recognition" and requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 is effective retrospectively for annual or interim reporting periods beginning after December 15, 2016, with early application not permitted. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.

 

In April 2014, the FASB issued ASU No. 2014-08, "Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity." ASU 2014-08 provides a narrower definition of discontinued operations than that provided under existing U.S. GAAP. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, which disposal represents a strategic shift that has, or will have, a major effect on the reporting entity's operations and financial results, should be reported in the financial statements as a discontinued operation. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. ASU 2014-08 is effective prospectively for disposals (or classifications as held for disposal) of components of an entity that occur in annual or interim periods beginning after December 15, 2014. The Company does not expect the adoption of ASU 2014-08 to have a material impact on its consolidated financial statements.  

12
 
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding:

 

· Our future sales and product revenue, including geographic expansions, possible retroactive price adjustments, and expectations of unit volumes or other offsets to price reductions;

 

· Our manufacturing capacity, 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 and/or maintain compliance with laws and regulations;

 

· The timing of and/or receipt of Food and Drug Administration (“FDA”), foreign or other regulatory approvals, clearances, and/or reimbursement approvals of current, new or potential products, and any limitations on such approvals;

 

· Our intention to seek patent protection for our products and processes, and to 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, license or supply agreements, and 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 expectations of product revenue results in future quarters and for the full year 2014;

 

· Our current strategy, including our corporate objectives, research and development activities and collaboration activities;

 

· Our expectations regarding our orthobiologics products, including existing products and expectations regarding new products, expanded uses of existing products, new distribution partnerships and revenue growth;

 

· Our intention to increase our market share for orthobiologics products in domestic and international markets or otherwise penetrate growing markets for osteoarthritis of the knee and other joints;

 

· Our expectations regarding next generation orthobiologics product development, clinical trials, regulatory approvals and commercial launches;

 

· Our and Bausch & Lomb’s performance under the non-exclusive, three-year contract for the supply of AMVISC ® and AMVISC ® Plus ophthalmic viscoelastic products, our expectations regarding revenue from ophthalmic products, and the impact that such agreement’s expiration will have on our results of operations going forward;

 

·

Our ability to commercialize ANIKAVISC® and ANIKAVISC® Plus and our expectations regarding such commercialization and the potential profits generated thereby;

 

· Our ability to license our aesthetics product to new distribution partners domestically and outside the U.S., and our expectations regarding development of aesthetics product line extensions;

 

·

Our ability and the ability of our distribution partners, to market our aesthetics dermatology product; and our expectations regarding the distribution and sales of our ELEVESS® product and the timing thereof;

 

· Our expectations regarding HYVISC ® sales;

 

13
 
· Our expectations regarding product gross margin;

 

· Our expectations regarding CINGAL ® , including the expense associated therewith, the timing of submission of our CE Mark application, and our ability to obtain regulatory approvals for this product;

 

· Possible negotiations or re-negotiations with existing or new distribution or collaboration partners;

 

· Our ability to continue streamlining operations and improving our manufacturing capabilities;

 

· 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 expectations regarding the adequacy and usage of such cash;

 

· Our expectation for capital expenditures and future amounts of interest income and expense;

 

· 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 manage the operations of Anika S.r.l. as a company generating continued profits;

 

· The strength of the economies in which the Company operates or will operate, as well as the political stability of any of those geographic areas;

 

· Our ability to effectively prioritize the many research and development projects underway;

 

· Our ability to expand the therapeutic applications of our existing products and create new applications for our HA technology;

 

· Our ability to obtain U.S. approval for 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; and

 

· Our ability to successfully defend the Company against lawsuits and claims, and the uncertain financial impact such lawsuits and claims and related defense costs may have on the Company.

 

Furthermore, additional statements identified by words such as “will,” “likely,” “may,” “believe,” “expect,” “anticipate,” “intend,” “seek,” “designed,” “develop,” “would,” “future,” “can,” “could,” and other expressions that are predictions of or indicate future events and trends and which do not relate to historical matters, also identify forward-looking statements.

 

You should not rely on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, some of which are beyond our control, including those factors described in the section titled “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. These risks, uncertainties and other factors may cause our actual results, performance or achievement to be materially different from anticipated future results, performance or achievement, expressed or implied by the forward-looking statements. These forward-looking statements are based upon the current assumptions of our management and are only expectations of future results. You should carefully review all of these factors, and you should be aware that there may be other factors that could cause these differences, including those factors discussed herein and in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this Quarterly Report on Form 10-Q, as well as the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2013 and in our press releases and other filings with the Securities and Exchange Commission. We undertake no obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors of new information, future events or other changes.

 

 

14
 

Management Overview

 

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.

 

Anika’s proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to intended therapeutic uses. Our patented technologies chemically modify the HA molecule to allow for longer residence time in the body. Anika Therapeutics, Inc.’s wholly-owned subsidiary, Anika Therapeutics S.r.l., has over 20 products currently commercialized. These products are also all made from HA, based on two technologies: “HYAFF,” which is a solid form of HA, and ACP gel, an autocross-linked polymer of HA. Both technologies are protected by an extensive portfolio of owned and licensed patents. We offer therapeutic products from these aforementioned technologies in the following areas:

 

    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    

 

Please see Management’s Discussion and Analysis of Financial Condition and Results of Operations-Management Overview (Item 7) to the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, for a description of each of the above therapeutic areas, including the individual products.

 

Research and Development

 

Anika’s research and development efforts primarily consist of the development of new medical applications for our HA-based technologies, the management of clinical trials and studies for certain product candidates, the preparation and processing of applications for regulatory approvals or clearances at all relevant stages of product development, and process development and scale-up manufacturing activities related to our existing and new products. Our development focus includes products for tissue protection, healing and repair. Our investment in R&D varies considerably depending on the timing, number and size of clinical trials and studies underway. We anticipate that we will commit significant resources to research and development, including clinical trials, in the future.

  

During the first quarter of 2014, the Company received FDA approval of MONOVISC and resolved the patent lawsuit with Genzyme Corporation. The Company received a milestone payment of $17,500,000 under the Mitek MONOVISC Agreement related to FDA approval of MONOVISC and the successful resolution of the Genzyme patent litigation. As a result of the full delivery of our development obligations under this agreement, the Company also recognized the remaining balance of deferred revenue relating to the initial $2,500,000 non-refundable up-front payment. Both amounts were fully recognized as revenue during the three months ended March 31, 2014.

 

A key product currently under development is CINGAL, which is based on our HA material with an added active therapeutic molecule designed to provide broad pain relief for a longer period of time. We completed the formulation and biocompatibility studies of the product. During the second quarter of 2013, we commenced a multinational phase III clinical trial to obtain the clinical data necessary for a CE Mark submission and approval, and to support other product registrations including in the United States. Enrollment in the clinical trial was completed in February 2014, and the last patient follow-up was completed in September 2014. We expect to submit our CE Mark application by December 31, 2014, or shortly thereafter.

 

HYALOFAST™ is an innovative biodegradable matrix for human bone marrow mesenchymal stem cells used in connection with soft tissue regeneration. HYALOFAST received CE Mark approval in September 2009, and it is currently commercially available in Europe and certain international countries. During the second quarter of 2014, we submitted a proposed investigational device protocol to the FDA. Our current plan is to begin a phase III clinical trial in 2015.

15
 

The technologies obtained through our acquisition of Anika S.r.l. have enhanced our research and development capabilities, and our pipeline of product candidates. Anika S.r.l. has research and development programs for new products including HYALOFAST and HYALOSPINE™, an adhesion prevention gel for use after spinal surgery. Our research and development efforts may not be successful in (1) developing our existing product candidates, (2) expanding the therapeutic applications of our existing products, or (3) resulting in new applications for our HA technology. There is also a risk that we may choose not to pursue development of potential product candidates. We also may not be able to obtain regulatory approval for any new applications we develop. 

 

Litigation and Other Legal Matters

 

On July 7, 2010, Genzyme Corporation filed a complaint against the Company in the United States District Court for the District of Massachusetts seeking unspecified damages and equitable relief. The complaint alleged that the Company infringed U.S. Patent No. 5,143,724 by manufacturing MONOVISC in the United States for sale outside the United States and would infringe U.S. Patent Nos. 5,143,724 and 5,399,351 if the Company manufactured and sold MONOVISC in the United States. On March 7, 2014 Genzyme and the Company filed a joint motion to lift the stay in Genzyme’s lawsuit against the Company and to dismiss with prejudice all of Genzyme’s claims. On March 10, 2014, the District Court granted the motion to dismiss with prejudice all of Genzyme’s claims against the Company and the case was terminated.

 

We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations or cash flows. 

 

Results of Operations

 

  Three and Nine Months Ended September 30, 2014 Compared to the Three and Nine Months Ended September 30, 2013

 

    Three Months Ended September 30,   Nine Months Ended September 30,
    2014   2013   Inc/(Dec)   2014   2013   Inc/(Dec)
Product revenue   $ 21,975,312     $ 17,023,346       29 %   $ 57,593,873     $ 51,585,242       12 %
Licensing, milestone and contract revenue     80,111       731,092       (89 %)     24,746,497       2,244,584       1002 %
Total revenue     22,055,423       17,754,438       24 %     82,340,370       53,829,826       53 %
                                                 
Operating expenses:                                                
Cost of product revenue     5,724,800       5,377,568       6 %     15,418,732       16,530,070       (7 %)
Research & development     1,999,867       1,618,012       24 %     6,160,740       5,029,974       22 %
Selling, general & administrative     4,044,538       3,188,669       27 %     11,401,399       10,536,462       8 %
Restructuring credits     -       (196,084 )     (100 %)     -       (442,869 )     (100 %)
Total operating expenses     11,769,205       9,988,165       18 %     32,980,871       31,653,637       4 %
Income from operations     10,286,218       7,766,273       32 %     49,359,499       22,176,189       123 %
Interest income (expense), net     9,937       (32,816 )     (130 %)     16,339       (108,755 )     (115 %)
Income before income taxes     10,296,155       7,733,457       33 %     49,375,838       22,067,434       124 %
Provision for income taxes     4,125,355       2,776,199       49 %     18,872,435       8,147,282       132 %
Net income   $ 6,170,800     $ 4,957,258       24 %   $ 30,503,403     $ 13,920,152       119 %
Product gross profit   $ 16,250,512     $ 11,645,778       40 %   $ 42,175,141     $ 35,055,172       20 %
Product gross margin     74 %     68 %             73 %     68 %        

 

16
 

Product Revenue

 

Product revenue for the quarter ended September 30, 2014 was $21,975,312, an increase of 29%, as compared to $17,023,346 for the quarter ended September 30, 2013. Product revenue for the nine-month period ended September 30, 2014 was $57,593,873, an increase of 12%, as compared to $51,585,242 for the nine-month period ended September 30, 2013. For the three months ended September 30, 2014, increases in product revenue from our Orthobiologics, Dermal and Surgical franchises were partially offset by timing related decreases in revenue from our Ophthalmic and Veterinary products. The increase in the nine-month period ended September 30, 2014 from the prior year period was primarily driven by MONOVISC product sales increases both domestically and internationally.

 

The following table presents product revenue by group for the three and nine-month periods ended September 30, 2014 and 2013:

 

    Three Months Ended September 30,   Increase (Decrease)
    2014   2013   $   %
  Orthobiologics     $ 18,899,873     $ 12,830,566     $ 6,069,307       47 %
  Dermal       401,355       267,766       133,589       50 %
  Surgical       1,452,946       1,136,248       316,698       28 %
  Ophthalmic       366,138       1,425,609       (1,059,471 )     (74 %)
  Veterinary       855,000       1,363,157       (508,157 )     (37 %)
        $ 21,975,312     $ 17,023,346     $ 4,951,966       29 %

 

    Nine Months Ended September 30,   Increase (Decrease)
    2014   2013   $   %
  Orthobiologics     $ 48,750,277     $ 40,620,339     $ 8,129,938       20 %
  Dermal       938,966       1,066,409       (127,443 )     (12 %)
  Surgical       4,581,496       3,955,134       626,362       16 %
  Ophthalmic       938,134       2,818,407       (1,880,273 )     (67 %)
  Veterinary       2,385,000       3,124,953       (739,953 )     (24 %)
        $ 57,593,873     $ 51,585,242     $ 6,008,631       12 %

 

Orthobiologics

 

Our orthobiologics franchise consists of our joint health and orthopedic products. Overall, sales increased 47% and 20% for the three and nine-month periods ended September 30, 2014, as compared to the same periods in 2013. The growth in the third quarter of 2014 reflected revenue from MONOVISC sales in the U.S. as a result of the product launch in April 2014. We expect orthobiologics product revenue to increase in 2014 as compared to 2013.

 

Dermal

 

Our dermal franchise consists of advanced wound care products and aesthetic dermal fillers. In July 2014, the Company entered into a new agreement with Medline Industries Inc. to commercialize HYALOMATRIX in the U.S. on an exclusive basis through 2019. For the three and nine month periods ended September 30, 2014, dermal product sales increased 50% and decreased 12%, respectively to $401,355 and $938,966, as compared to the same periods in 2013. The fluctuations primarily reflect order timing by our distribution partners. Anika’s advanced wound care products treat complex skin wounds ranging from burns to diabetic ulcers, with HYALOMATRIX® and HYALOFILL® as the lead products. We expect revenue from our dermal products to grow in the fourth quarter from the third quarter of 2014.

 

Surgical  

 

Our surgical franchise consists of products used to prevent post-surgical adhesions in abdominal-pelvic, spinal, and ear, nose and throat (“ENT”) disorders. Sales of our surgical products increased 28% and 16% for the three and nine-month periods ended September 30, 2014 to $1,452,946 and $4,581,496 respectively, as compared to the same periods in 2013. The year-to-date increase of surgical product revenue was primarily due to strong demand for our HYALOBARRIER® product from our European and Asian partners. For the full year 2014, we expect revenue from our surgical products to increase as compared to 2013. 

 

17
 

Ophthalmic

 

Our ophthalmic franchise consists of HA viscoelastic products used in ophthalmic surgery. Ophthalmic product sales decreased 74% and 67% to $366,138 and $938,134, respectively, for the three and nine-month periods ended September 30, 2014, as compared to the same periods in 2013. The decrease was primarily attributable to Bausch & Lomb (“B&L”) delaying its contractual minimum purchases until the fourth quarter of 2014. We expect the overall ophthalmic revenue to be lower in 2014, as compared to 2013, due to the terms of the current Bausch & Lomb supply agreement. B&L’s current contract expires at the end of this year and will not be renewed. Given that the ophthalmic franchise is not part of our core business, and that it has been steadily diminishing for the past few years, we do not expect this event to have a material impact on our results going forward.

 

Veterinary

 

Veterinary revenue from HYVISC decreased by 37% to $855,000 and 24% to $2,385,000 for the three and nine-month periods ended September 30, 2014, respectively, as compared to the same periods in 2013. We expect the overall veterinary revenue to be slightly lower in 2014, as compared to 2013 due to order timing and a slight downward trend in the number of performance horses in the U.S. We continue to look at other veterinary applications and opportunities to expand geographic territories.

  

Licensing, milestone and contract revenue   

 

Licensing, milestone and contract revenue for the three and nine-month periods ended September 30, 2014 was $80,111 and $24,746,497, respectively, as compared to $731,092 and $2,244,584 for the same periods in 2013. Revenue for the quarter ended June 30, 2014 included a $5,000,000 milestone payment associated with our U.S. license agreement for MONOVISC. The year to date September 30, 2014 increase in licensing, milestone and contract revenue included a $17,500,000 milestone payment resulting from the resolution of the patent litigation with Genzyme and the FDA approval of MONOVISC, and the recognition of an approximately $2,200,000 remaining unamortized upfront payment previously received in December 2011. These payments are related to development obligations under the license agreement. The FDA’s approval of our MONOVISC product during the quarter ended March 31, 2014 completed the delivery of our development obligations under the license agreement, and resulted in the immediate recognition of the $17.5 million milestone payment, as well as the full recognition of prior deferred revenue in the first quarter of 2014. During the second quarter of 2014, a $5,000,000 milestone payment associated with the first commercial sale of MONOVISC in the U.S. was earned, received, and recognized as revenue.

 

Product gross profit and margin   

 

Product gross profit and margin for the three and nine-month periods ended September 30, 2014 was $16,250,512 and $42,175,141, or 74% and 73%, respectively, of the product revenue. Product gross margin for the three and nine-month periods ended September 30, 2013 was $11,645,778 and $35,055,172, or 68% of the product revenue for each period, respectively. The increase in product gross margin for the three and nine-month periods ended September 30, 2014, as compared to the same periods in 2013, is attributable to a more favorable product mix, materials cost reduction, and continued efficiency gains at our Bedford, Massachusetts manufacturing facility. This quarter’s product gross margin may not be indicative of the rest of the year due to dynamics including the future mix of our product sales and other factors.

 

Research and development   

 

Research and development expenses for the three and nine-month periods ended September 30, 2014 were $1,999,867 and $6,160,740, or 9% and 8% of total revenue, respectively. This primarily reflects the completion of patient follow-up activities of our phase III Cingal clinical trial during the first nine months of 2014, as compared to trial start-up activities in the same periods last year. Research and development spending is expected to increase in future quarters as we further develop new products based on our existing technology assets.  

 

Selling, general and administrative   

 

Selling, general and administrative (“SG&A”) expenses for the three and nine-month periods ended September 30, 2014 were $4,044,538 and $11,401,399, or, representing 19% and 14% of total revenue, respectively. SG&A expenses increased for both the three and nine-month periods ending September 30, 2014, as compared to the same periods in 2013, primarly as a result of increases in personnel related costs, external professional fees, and corporate goverance costs. Included in the first quarter of 2013 were certain non-recurring external professional fees and personnel costs. We expect general and administrative expenses to increase in 2014, as compared to 2013, reflective of the support required to grow our business both domestically and internationally.

 

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Income taxes

 

Provisions for income taxes were $4,125,355 and $18,872,435 for the three and nine-month periods ended September 30, 2014, based on effective tax rates of 40% and 38%, respectively. Provisions for income taxes were $2,776,199 and $8,147,282 for the three and nine-month periods ended September 30, 2013, respectively, based on effective tax rates of 36% and 37%, respectively. The increase in income taxes over the three-month period ended September 30, 2014 was primarily due to increased net income. The increase in income taxes over the nine-month period ended September 30, 2014 was primarily due to increased net income, which reflected $24,652,778 in milestone and contract revenue associated with our U.S. license agreement for MONOVISC. The increase in the effective tax rate for each of the periods ended 2014, as compared to the same periods ended in 2013, was driven primarily by the unavailability of the federal R&D tax credit in 2014, due to its expiration on December 31, 2013, and a relative decrease to our estimated production activities deduction.

 

The Company files income tax returns in the U.S. on a federal basis, 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. Our filings from 2011 through the present tax year remain subject to examination by the IRS and other taxing authorities for U.S. federal and state tax purposes. Our filings from 2009 through the present tax year 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. We have concluded that the positive evidence outweighs the negative evidence and, thus, those deferred tax assets are realizable on a “more likely than not” basis. As such, we have not recorded a valuation allowance at September 30, 2014 or December 31, 2013. 

 

Liquidity and Capital Resources

 

We require cash to fund our operating expenses and capital expenditures. We expect that our requirements for cash to fund operations will increase as the scope of our operations expands. Historically, we have generated positive cash flow from operations, which together with our available cash and investments, have met our cash requirements. Cash, cash equivalents and investments totaled approximately $91.8 million and $63.3 million at September 30, 2014 and December 31, 2013, respectively. Working capital totaled approximately $122.2 million at September 30, 2014 and $85.3 million at December 31, 2013. The Company believes it has adequate financial resources to support its business for the next twelve months.

 

Cash provided by operating activities was $25,222,372 for the nine months ended September 30, 2014, as compared to cash provided by operating activities of $17,159,199 for the same period in the prior year. This increase in cash provided by operations was due primarily to a total of $22.5 million milestone payments received under the Mitek MONOVISC Agreement. This cash inflow is partially offset by an increase in inventory due to anticipated future sales demand.

 

Cash used in investing activities was $20,919,301 for the nine months ended September 30, 2014 as compared to cash provided by investing activities of $295,062 for the same period in 2013. The increase in cash used in investing activities is primarily the result of the purchase of approximately $20.0 million in marketable securities during the third quarter as well as higher capital expenditures in 2014 as compared to the same period in 2013, which included the proceeds received from the sale of property and equipment in the prior year period relating to our reorganization of Anika S.r.l. in the beginning of 2013.

 

Cash provided by financing activities was $4,267,102 for the nine months ended September 30, 2014, as compared to cash provided by financing activities of $2,496,830 for the same period in 2013. The increase in cash provided by financing activities in the current year’s period is attributable to the increased tax benefits received in regards to employees’ exercise of stock options during the first nine months of 2014, partially offset by minimum tax withholdings on share-based awards.

 

Critical Accounting Estimates

 

During the nine months ended September 30, 2014, the Company received FDA approval of MONOVISC and the patent litigation related to MONOVISC was also resolved. As a result, the Company shortened the estimate of the performance period related to the Mitek MONOVISC Agreement. There were no other significant changes in our critical accounting estimates during the nine months ended September 30, 2014, as compared to the estimates disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013.

 

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Recent Accounting Pronouncements

 

In June 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-12, “Compensation - Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide that a Performance Target Could be Achieved after the Requisite Service Period, which requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. Thus, the performance target should not be reflected in estimating the grant date fair value of the award. This update further clarifies that compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. The new guidance is effective for the Company beginning January 1, 2016. Early adoption is permitted. The Company is currently evaluating the impact of this new standard on its financial statements.

 

In May 2014, the FASB issued ASU No. 2014-09, "Revenue from Contracts with Customers." ASU 2014-09 supersedes the revenue recognition requirements in "Topic 605, Revenue Recognition" and requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 is effective retrospectively for annual or interim reporting periods beginning after December 15, 2016, with early application not permitted. The Company is currently evaluating the impact of this new standard on its financial statements.

 

In April 2014, the FASB issued ASU No. 2014-08, "Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity." ASU 2014-08 provides a narrower definition of discontinued operations than under existing U.S. GAAP. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, that represents a strategic shift that has, or will have, a major effect on the reporting entity's operations and financial results should be reported in the financial statements as discontinued operations. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. ASU 2014-08 is effective prospectively for disposals (or classifications as held for disposal) of components of an entity that occur in annual or interim periods beginning after December 15, 2014. The Company does not expect the adoption of ASU 2014-08 to have a material impact on the consolidated financial statements.  

 

Contractual Obligations and Other Commercial Commitments

 

We have had no material changes outside the ordinary course to our contractual obligations disclosed in our Annual Report on Form 10-K for the period ended December 31, 2013.

 

To the extent that funds generated from our operations, together with our existing capital resources, are insufficient to meet future requirements, we will be required to obtain additional funds through equity or debt financings, strategic alliances with corporate partners and others, or through other sources. No assurance can be given that any additional financing will be made available to us or will be available on acceptable terms should such a need arise.

 

Off-balance Sheet Arrangements

 

The Company does not use special purpose entities or other off-balance sheet financing techniques, except for operating leases, that we believe have, or are reasonably likely to have, a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity or capital resources.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

There have been no material changes to our market risks since the date of our Annual Report on Form 10-K for the year ended December 31, 2013.

 

As of September 30, 2014, we did not utilize any derivative financial or commodity instruments for which fair value disclosure would be required under ASC 825, Financial Instruments , or ASC 815, Derivatives and Hedging . Our marketable securities investments consist of money market funds primarily invested in certificates of deposit, commercial paper, U.S. Treasury obligations and repurchase agreements secured by U.S. Treasury obligations that are carried on our books at fair market value.

 

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Primary Market Risk Exposures

 

Our primary market risk exposure is in the area of currency rate risk. We have three supplier contracts denominated in foreign currencies. Unfavorable fluctuations in exchange rates would have a negative impact on our financial statements. The impact of changes in currency exchange rates for these supplier contracts on our financial statements was immaterial for the three months ended September 30, 2014. The impact of exchange rates related to the consolidation of the balance sheet amounts for our Anika S.r.l. subsidiary resulted in an unfavorable currency translation adjustment of $1,896,823 during the first nine months of 2014.

 

Our investment portfolio of cash equivalents and marketable securities is subject to interest rate fluctuations, changes in credit quality of the issuer or other factors.

 

ITEM 4. CONTROLS AND PROCEDURES

 

  (a) Evaluation of disclosure controls and procedures.
     
  As required by Rule 13a-15 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we carried out an evaluation under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based upon that evaluation, the chief executive officer and principal financial officer have concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in Securities and Exchange Commission rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including our chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure. On an on-going basis, we review and document our disclosure controls and procedures, and our internal control over financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our business.

 

  (b) Changes in internal controls over financial reporting.
     
  There were no changes in our internal control over financial reporting during the three-month period ended September 30, 2014 that have materially affected, or that are reasonably likely to materially affect, our internal controls over financial reporting.

 

 

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PART II: OTHER INFORMATION

 

ITEM 1.  LEGAL PROCEEDINGS

 

On July 7, 2010, Genzyme Corporation filed a complaint against the Company in the United States District Court for the District of Massachusetts seeking unspecified damages and equitable relief. The complaint alleged that the Company infringed U.S. Patent No. 5,143,724 by manufacturing MONOVISC in the United States for sale outside the United States and would infringe U.S. Patent Nos. 5,143,724 and 5,399,351 if the Company manufactured and sold MONOVISC in the United States. On March 7, 2014, Genzyme and the Company filed a joint motion to lift the stay in Genzyme’s lawsuit against the Company and to dismiss with prejudice all of Genzyme’s claims. On March 10, 2014, the District Court granted the motion to dismiss with prejudice all of Genzyme’s claims against the Company and the case was terminated.

 

We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations or cash flow. 

 

ITEM 1A. RISK FACTORS

 

To our knowledge there have been no material changes to the risk factors described in “Part I., Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2013. In addition to the other information set forth in this report, you should carefully consider the factors discussed in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2013, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

 

ITEM 5. OTHER INFORMATION

 

On November 5, 2014, our Board of Directors approved a form of indemnification agreement for our directors and authorized the Company to enter into such an agreement with each of our directors.  Under the terms of the agreement, consistent with the provisions of our Articles of Incorporation, Bylaws and applicable law, the Company agrees to indemnify each director, to the maximum extent permitted by the laws of the Commonwealth of Massachusetts, from claims and losses arising from their service as a director.  Subject to certain procedures outlined in the agreement, we are required to advance expenses incurred as a result of any such proceeding as to which a director could be indemnified.  The agreement provides procedures for the determination of a person’s right to receive indemnification consistent with applicable laws.  We anticipate that we will enter into substantially similar agreements with any new directors.  The form of indemnification agreement is attached hereto as Exhibit 10.1 and incorporated by reference herein.  The foregoing summary of the indemnification agreement is qualified in its entirety by the text of the Exhibit.

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ITEM 6. EXHIBITS

 

Exhibit No.   Description
         
*10.1   Form of Director Indemnification Agreement
         
(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
         
    The following materials from Anika Therapeutics, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, as filed with the SEC on November 5, 2014, formatted in XBRL (eXtensible Business Reporting Language), as follows:
         
    i.   Condensed Consolidated Balance Sheets as of September 30, 2014 (unaudited) and December 31, 2013
         
    ii.   Condensed Consolidated Statements of Operations and Comprehensive Income for the Three and Nine Months Ended September 30, 2014 and September 30, 2013 (unaudited)
         
    iii.   Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2014 and September 30, 2013 (unaudited)
         
    iv.   Notes to Condensed Consolidated Financial Statements (unaudited)

 

* Filed herewith
**  Furnished herewith.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    ANIKA THERAPEUTICS, INC.
   
Date: November 5, 2014 By: /s/ SYLVIA CHEUNG
    Sylvia Cheung
    Chief Financial Officer
    (Authorized Officer and Principal Financial Officer)

 

 

 

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Exhibit 10.1

 

DIRECTOR INDEMNIFICATION AGREEMENT

This Indemnification Agreement (“ Agreement ”) is made as of November 5, 2014 by and between Anika Therapeutics, Inc., a Massachusetts corporation (the “ Company ”), and ____________ (“ Indemnitee ”).

 

RECITALS

 

WHEREAS, the Company desires to attract and retain the services of highly qualified individuals, such as Indemnitee, to serve the Company;

 

WHEREAS, in order to induce Indemnitee to provide or continue to provide services to the Company, the Company wishes to provide for the indemnification of, and advancement of expenses to, Indemnitee to the maximum extent permitted by law;

 

WHEREAS, the Articles of Organization (as amended and in effect on the date hereof, the “ Charter ”) and the Bylaws (as amended and in effect on the date hereof, the “ Bylaws ” and, together with the Charter, the “ Organizational Documents ”) of the Company require indemnification of the directors, officers and employees of the Company, and Indemnitee may also be entitled to indemnification pursuant to the Massachusetts Business Corporation Act (the “ MBCA ”);

 

WHEREAS, the Bylaws and the MBCA expressly provide that the indemnification provisions set forth therein are not exclusive, and thereby contemplate that contracts may be entered into between the Company and members of the board of directors, officers and other persons with respect to indemnification;

 

WHEREAS, the Board of Directors of the Company (the “ Board ”) has determined that the increased difficulty in attracting and retaining highly qualified persons such as Indemnitee is detrimental to the best interests of the Company’s shareholders;

 

WHEREAS, it is reasonable, prudent and necessary for the Company contractually to obligate itself to indemnify, and to advance expenses on behalf of, such persons to the fullest extent permitted by applicable law, regardless of any amendment or revocation of the Organizational Documents so that they will serve or continue to serve the Company free from undue concern that they will not be so indemnified; and

 

WHEREAS, this Agreement is a supplement to and in furtherance of the indemnification provided in the Organizational Documents and any resolutions adopted pursuant thereto, and shall not be deemed a substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder.

 

NOW, THEREFORE, in consideration of the premises and the covenants contained herein, the Company and Indemnitee do hereby covenant and agree as follows:

 

1
 

Section 1. Services to the Company . Indemnitee agrees to serve as a director of the Company. Indemnitee may at any time and for any reason resign from such position (subject to any other contractual obligation or any obligation imposed by law), in which event the Company shall have no obligation under this Agreement to continue Indemnitee in such position. This Agreement shall not be deemed an employment contract between the Company (or any of its subsidiaries or any Enterprise) and Indemnitee.

 

Section 2. Definitions .

 

As used in this Agreement:

 

(a) “ Change in Control ” shall mean (i) the sale of all or substantially all of the assets of the Company on a consolidated basis to an unrelated person or entity, (ii) a merger, reorganization or consolidation pursuant to which the holders of the Company’s outstanding voting power and outstanding stock immediately prior to such transaction do not own a majority of the outstanding voting power and outstanding stock or other equity interests of the resulting or successor entity (or its ultimate parent, if applicable) immediately upon completion of such transaction, (iii) the sale of all of the capital stock of the Company to an unrelated person, entity or group thereof acting in concert, or (iv) any other transaction in which the owners of the Company’s outstanding voting power immediately prior to such transaction do not own at least a majority of the outstanding voting power of the Company or any successor entity immediately upon completion of the transaction other than as a result of the acquisition of securities directly from the Company.

 

(b) “ Corporate Status ” describes the status of a person as a current or former director of the Company or current or former director, manager, partner, officer, employee, agent or trustee of any other Enterprise which such person is or was serving at the request of the Company.

 

(c) “ Enforcement Expenses ” shall include all reasonable attorneys’ fees, court costs, transcript costs, fees of experts, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, and all other out-of-pocket disbursements or expenses of the types customarily incurred in connection with an action to enforce indemnification or advancement rights, or an appeal from such action. Expenses, however, shall not include fees, salaries, wages or benefits owed to Indemnitee.

 

(d) “ Enterprise ” shall mean any corporation (other than the Company), partnership, joint venture, trust, employee benefit plan, limited liability company, or other legal entity of which Indemnitee is or was serving at the request of the Company as a director, manager, partner, officer, employee, agent or trustee.

 

(e) “ Expenses ” shall include all reasonable attorneys’ fees, court costs, transcript costs, fees of experts, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, and all other out-of-pocket disbursements or expenses of the types customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, being or preparing to be a witness in, or otherwise participating in, a Proceeding or an appeal resulting from a Proceeding. Expenses, however, shall not include amounts paid in settlement by Indemnitee, the amount of judgments or fines against Indemnitee or compensatory, service or similar fees, salaries, wages or benefits owed to Indemnitee.

 

2
 

(f) “ Special Legal Counsel ” means a law firm, or a partner (or, if applicable, member or shareholder) of such a law firm, that is experienced in matters of Massachusetts corporation law and neither presently is, nor in the past has been, retained to represent: (i) the Company, any subsidiary of the Company, any Enterprise or Indemnitee in any matter material to any such party; or (ii) any other party to the Proceeding giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term “Special Legal Counsel” shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement. The Company agrees to pay the reasonable fees and expenses of the Special Legal Counsel referred to above and to fully indemnify such counsel against any and all expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.

 

(g) The term “ Proceeding ” shall include any threatened, pending or completed action, suit, alternate dispute resolution mechanism, or proceeding, whether brought in the right of the Company or otherwise and whether of a civil, criminal, administrative, arbitrative or investigative nature, and whether formal or informal, in which Indemnitee was, is or will be involved as a party or otherwise, by reason of the fact that Indemnitee is or was a director of the Company or is or was serving at the request of the Company as a director, manager, partner, officer, employee, agent or trustee of any Enterprise or by reason of any action taken by Indemnitee or of any action taken on his or her part while acting as a director of the Company or while serving at the request of the Company as a director, manager, partner, officer, employee, agent or trustee of any Enterprise, in each case whether or not serving in such capacity at the time any liability or expense is incurred for which indemnification, reimbursement or advancement of expenses can be provided under this Agreement; provided , however , that the term “Proceeding” shall not include any action, suit or arbitration, or part thereof, initiated by Indemnitee to enforce Indemnitee’s rights under this Agreement as provided for in Section 12(a) of this Agreement.

 

Section 3. Indemnity in Third-Party Proceedings . The Company shall indemnify Indemnitee to the extent set forth in this Section 3 if Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding, other than a Proceeding by or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 3, Indemnitee shall be indemnified against all Expenses, judgments, fines, penalties, excise taxes, and amounts paid in settlement actually and reasonably incurred by Indemnitee or on his or her behalf in connection with such Proceeding or any claim, issue or matter therein, if (A) Indemnitee conducted himself or herself in good faith and in a manner he or she reasonably believed to be in the best interests of the Company, or at least not opposed to the best interests of the Company, and, in the case of a criminal proceeding, had no reasonable cause to believe that his or her conduct was unlawful, or (B) Indemnitee engaged in conduct for which he or she shall not be liable under a provision of the Charter as authorized by Section 2.02(b)(4) of the MBCA (or any successor provision). The conduct of Indemnitee with respect to an employee benefit plan for a purpose Indemnitee reasonably believed to be in the best interests of the participants in, and the beneficiaries of, the plan is conduct that satisfies clause (A) of the preceding sentence.

 

3
 

Section 4. Indemnity in Proceedings by or in the Right of the Company . The Company shall indemnify Indemnitee to the extent set forth in this Section 4 if Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding by or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 4, Indemnitee shall be indemnified against all Expenses, judgments, fines, penalties, excise taxes, and amounts paid in settlement actually and reasonably incurred by Indemnitee or on his or her behalf in connection with such Proceeding or any claim, issue or matter therein, if (A) Indemnitee conducted himself in good faith and in a manner he or she reasonably believed to be in the best interests of the Company, or at least not opposed to the best interests of the Company, or (B) Indemnitee engaged in conduct for which he or she shall not be liable under a provision of the Charter as authorized by Section 2.02(b)(4) of the MBCA (or any successor provision). The conduct of Indemnitee with respect to an employee benefit plan for a purpose Indemnitee reasonably believed to be in the best interests of the participants in, and the beneficiaries of, the plan is conduct that satisfies clause (A) of the preceding sentence.

 

Section 5. Indemnification for Expenses of a Party Who is Successful . Notwithstanding any other provisions of this Agreement and except as provided in Section 7, to the extent that Indemnitee is a party to or a participant in any Proceeding and is wholly successful, on the merits or otherwise, in such Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by him or her in connection therewith. If in such Proceeding Indemnitee is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on his or her behalf in connection with each successfully resolved claim, issue or matter to the extent permitted by law. For purposes of this Section 5 and without limitation, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to be a successful result as to such claim, issue or matter.

 

Section 6. Reimbursement for Expenses of a Witness or in Response to a Subpoena . Notwithstanding any other provision of this Agreement, to the extent that Indemnitee, by reason of his or her Corporate Status, (i) is a witness in any Proceeding to which Indemnitee is not a party and is not threatened to be made a party or (ii) receives a subpoena with respect to any Proceeding to which Indemnitee is not a party and is not threatened to be made a party, the Company shall reimburse Indemnitee for all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection therewith.

 

Section 7. Exclusions . Notwithstanding any provision in this Agreement to the contrary, the Company shall not be obligated under this Agreement:

 

(a) to indemnify for amounts otherwise indemnifiable hereunder (or for which advancement is provided hereunder) if and to the extent that Indemnitee has otherwise actually received such amounts under any insurance policy, contract, agreement or otherwise;

 

4
 

(b) to indemnify for an accounting of profits made from the purchase and sale (or sale and purchase) by Indemnitee of securities of the Company within the meaning of Section 16(b) of the Securities Exchange Act of 1934, as amended, or similar provisions of state statutory law or common law;

 

(c) to indemnify with respect to any Proceeding, or part thereof, brought by Indemnitee against the Company, any legal entity which it controls, any director or officer thereof or any third party, unless (i) the Board has consented to the initiation of such Proceeding or part thereof and (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law; provided , however , that this Section 7(c) shall not apply to (A) counterclaims or affirmative defenses asserted by Indemnitee in an action brought against Indemnitee or (B) any action brought by Indemnitee for indemnification or advancement from the Company under this Agreement or under any directors’ and officers’ liability insurance policies maintained by the Company in the suit for which indemnification or advancement is being sought as described in Section 12; or

 

(d) to provide any indemnification or advancement of expenses that is prohibited by applicable law (as such law exists at the time payment would otherwise be required pursuant to this Agreement).

 

Section 8. Advancement of Expenses . Subject to Section 9(b), the Company shall advance, to the extent not prohibited by law, the Expenses incurred by Indemnitee in connection with any Proceeding, and such advancement shall be made within thirty (30) days after the receipt by the Company of a statement or statements requesting such advances (which shall include invoices received by Indemnitee in connection with such Expenses but, in the case of invoices in connection with legal services, any references to legal work performed or to expenditures made that would cause Indemnitee to waive any privilege accorded by applicable law need not be included with the invoice) from time to time, whether prior to or after final disposition of any Proceeding. Advances shall be unsecured and interest free. Advances shall be made without regard to Indemnitee’s ability to repay the expenses and without regard to Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement. Indemnitee shall qualify for advances upon the execution and delivery to the Company of an undertaking in the form attached hereto as Exhibit A . The right to advances under this Section 8 shall in all events continue until final disposition of any Proceeding, including any appeal therein. Nothing in this Section 8 shall limit Indemnitee’s right to advancement pursuant to Section 12(e) of this Agreement.

 

Section 9. Procedure for Notification and Defense of Claim .

(a) To obtain indemnification under this Agreement, Indemnitee shall submit to the Company a written request therefor specifying the basis for the claim, the amounts for which Indemnitee is seeking payment under this Agreement, and all documentation related thereto as reasonably requested by the Company (a “ Written Indemnification Request ”).

 

(b) In the event that the Company shall be obligated hereunder to provide indemnification for or make any advancement of Expenses with respect to any Proceeding, the Company shall be entitled to assume the defense of such Proceeding, or any claim, issue or matter therein, with counsel approved by Indemnitee (which approval shall not be unreasonably withheld or delayed) upon the delivery to Indemnitee of written notice of the Company’s election to do so. After delivery of such notice, approval of such counsel by Indemnitee and the retention of such counsel by the Company, the Company will not be liable to Indemnitee under this Agreement for any fees or expenses of separate counsel subsequently employed by or on behalf of Indemnitee with respect to the same Proceeding; provided that (i) Indemnitee shall have the right to employ separate counsel in any such Proceeding at Indemnitee’s expense and (ii) if (A) the employment of separate counsel by Indemnitee has been previously authorized by the Company, (B) Indemnitee shall have reasonably concluded that there may be a conflict of interest between the Company and Indemnitee in the conduct of such defense, or (C) the Company shall not continue to retain such counsel to defend such Proceeding, then the reasonable fees and expenses actually and reasonably incurred by Indemnitee with respect to his or her separate counsel shall be Expenses hereunder.

 

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(c) In the event that the Company does not assume the defense in a Proceeding pursuant to paragraph (b) above, then the Company will be entitled to participate in the Proceeding at its own expense.

 

(d) The Company shall not be liable to indemnify Indemnitee under this Agreement for any amounts paid in settlement of any Proceeding effected without its prior written consent (which consent shall not be unreasonably withheld or delayed). The Company shall not, without the prior written consent of Indemnitee (which consent shall not be unreasonably withheld or delayed), enter into any settlement which (i) includes an admission of fault of Indemnitee, any non-monetary remedy imposed on Indemnitee or any monetary damages for which Indemnitee is not wholly and actually indemnified hereunder or (ii) with respect to any Proceeding with respect to which Indemnitee may be or is made a party or may be otherwise entitled to seek indemnification hereunder, does not include the full release of Indemnitee from all liability in respect of such Proceeding.

Section 10. Procedure Upon Application for Indemnification .

 

(a) Upon written request by Indemnitee for indemnification pursuant to Section 9(a), a determination, if such determination is required by applicable law, with respect to the permissibility thereof shall be made in the specific case: (i) if a Change in Control shall have occurred, by Special Legal Counsel in a written opinion to the Board, or (ii) if a Change in Control shall not have occurred, by the Company in accordance with applicable law. In the case that such determination is made by Special Legal Counsel, a copy of Special Legal Counsel’s written opinion shall be delivered to Indemnitee and, if it is so determined that Indemnitee is entitled to indemnification, payment to Indemnitee shall be made within thirty (30) days after such determination. Indemnitee shall cooperate with the Special Legal Counsel or the Company, as applicable, in making such determination with respect to the permissibility of indemnification of Indemnitee, including providing to such counsel or the Company, upon reasonable advance request, any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to such determination. Any out-of-pocket costs or expenses (including reasonable attorneys’ fees and disbursements) actually and reasonably incurred by Indemnitee in so cooperating with the Special Legal Counsel or the Company shall be borne by the Company (irrespective of the determination as to the permissibility of indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee harmless therefrom.

 

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(b) If the determination of permissibility of indemnification is to be made by Special Legal Counsel pursuant to Section 10(a), the Special Legal Counsel shall be selected by the Company in accordance with applicable law. The Indemnitee may, within ten (10) days after written notice of such selection, deliver to the Company a written objection to such selection; provided , however , that such objection may be asserted only on the ground that the Special Legal Counsel so selected does not meet the requirements of “Special Legal Counsel” as defined in Section 2 of this Agreement, and the objection shall set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person so selected shall act as Special Legal Counsel. If such written objection is so made and substantiated, the Special Legal Counsel so selected may not serve as Special Legal Counsel unless and until such objection is withdrawn or the Massachusetts Court (as defined in Section 22) has determined that such objection is without merit. If, within twenty (20) days after the later of (i) submission by Indemnitee of a Written Indemnification Request, and (ii) the final disposition of the Proceeding, including any appeal therein, no Special Legal Counsel shall have been selected without objection, Indemnitee may petition the Massachusetts Court for resolution of any objection which shall have been made by Indemnitee to the selection of Special Legal Counsel and/or for the appointment as Special Legal Counsel of a person selected by the court or by such other person as the court shall designate. The person with respect to whom all objections are so resolved or the person so appointed shall act as Special Legal Counsel under Section 10(a) hereof. Upon the due commencement of any judicial proceeding or arbitration pursuant to Section 12(a) of this Agreement, Special Legal Counsel shall be discharged and relieved of any further responsibility in such capacity (subject to the applicable standards of professional conduct then prevailing).

 

Section 11. Presumptions and Effect of Certain Proceedings .

(a) To the extent permitted by applicable law, in making a determination with respect to the permissibility of indemnification hereunder, it shall be presumed that Indemnitee is entitled to indemnification under this Agreement if Indemnitee has submitted a Written Indemnification Request in accordance with Section 9(a) of this Agreement, and the Company shall have the burden of proof to overcome that presumption in connection with the making of any determination contrary to that presumption. Neither (i) the failure of the Company or of Special Legal Counsel to have made a determination prior to the commencement of any action pursuant to this Agreement that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor (ii) an actual determination by the Company or by Special Legal Counsel that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct.

 

(b) The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee did not meet the applicable standard of conduct for indemnification under this Agreement.

 

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(c) The knowledge and/or actions, or failure to act, of any director, manager, partner, officer, employee, agent or trustee of the Company, any subsidiary of the Company, or any Enterprise shall not be imputed to Indemnitee for purposes of determining the right to indemnification under this Agreement.

 

Section 12. Remedies of Indemnitee .

 

(a) Subject to Section 12(f), in the event that (i) a determination is made pursuant to Section 10 of this Agreement that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to Section 8 of this Agreement, (iii) no determination of entitlement to indemnification shall have been made pursuant to Section 10(a) of this Agreement within sixty (60) days after receipt by the Company of the Written Indemnification Request for which a determination of permissibility thereof is to be made other than by Special Legal Counsel, (iv) payment of indemnification or reimbursement of expenses is not made pursuant to Section 5 or 6 or the last sentence of Section 10(a) of this Agreement within thirty (30) days after receipt by the Company of a Written Indemnification Request therefor (which shall include any invoices received by Indemnitee but, in the case of invoices in connection with legal services, any references to legal work performed or to expenditures made that would cause Indemnitee to waive any privilege accorded by applicable law need not be included with the invoice) or (v) payment of indemnification pursuant to Section 3 or 4 of this Agreement is not made within thirty (30) days after a determination has been made that Indemnitee is entitled to indemnification, Indemnitee shall be entitled to an adjudication by the Massachusetts Court of his or her entitlement to such indemnification or advancement. Alternatively, Indemnitee, at his or her option, may seek an award in arbitration to be conducted by a single arbitrator pursuant to the Commercial Arbitration Rules of the American Arbitration Association. Indemnitee shall commence such proceeding seeking an adjudication or an award in arbitration within one hundred and eighty (180) days following the date on which Indemnitee first has the right to commence such proceeding pursuant to this Section 12(a); provided , however , that the foregoing time limitation shall not apply in respect of a proceeding brought by Indemnitee to enforce his or her rights under Section 5 of this Agreement. The Company shall not oppose Indemnitee’s right to seek any such adjudication or award in arbitration.

 

(b) In the event that a determination shall have been made pursuant to Section 10(a) of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding or arbitration commenced pursuant to this Section 12 shall be conducted in all respects as a de novo trial, or arbitration, on the merits and Indemnitee shall not be prejudiced by reason of that adverse determination. In any judicial proceeding or arbitration commenced pursuant to this Section 12, the Company shall have the burden of proving Indemnitee is not entitled to indemnification or advancement, as the case may be.

 

(c) If a determination shall have been made pursuant to Section 10(a) of this Agreement that Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any judicial proceeding or arbitration commenced pursuant to this Section 12, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading, in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law.

 

8
 

(d) The Company shall be precluded from asserting in any judicial proceeding or arbitration commenced pursuant to this Section 12 that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court or before any such arbitrator that the Company is bound by all the provisions of this Agreement.

 

(e) The Company shall indemnify Indemnitee to the fullest extent permitted by law against any and all Enforcement Expenses and, if requested by Indemnitee, shall (within thirty (30) days after receipt by the Company of a Written Indemnification Request therefor) advance, to the extent not prohibited by law, such Enforcement Expenses to Indemnitee, which are incurred by Indemnitee in connection with any action brought by Indemnitee for indemnification or advancement from the Company under this Agreement or under any directors’ and officers’ liability insurance policies maintained by the Company, regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification, advancement or insurance recovery, as the case may be, in the suit for which indemnification or advancement is being sought. Such Written Indemnification Request for advancement shall include invoices received by Indemnitee in connection with such Enforcement Expenses but, in the case of invoices in connection with legal services, any references to legal work performed or to expenditures made that would cause Indemnitee to waive any privilege accorded by applicable law need not be included with the invoice.

(f) Notwithstanding anything in this Agreement to the contrary, no determination as to entitlement to indemnification under this Agreement shall be required to be made prior to the final disposition of the Proceeding, including any appeal therein.

 

Section 13. Non-exclusivity; Survival of Rights; Insurance; Subrogation .

 

(a) The rights of indemnification and to receive advancement as provided by this Agreement shall not be deemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the Organizational Documents, any agreement, a vote of shareholders or a resolution of directors, or otherwise. No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee in his or her Corporate Status prior to such amendment, alteration or repeal. To the extent that a change in Massachusetts law, whether by statute or judicial decision, permits greater indemnification or advancement than would be afforded currently under the Organizational Documents and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such change. No right or remedy herein conferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy.

(b) To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors, managers, partners, officers, employees, agents or trustees of the Company or of any other Enterprise, Indemnitee shall be covered by such policy or policies in accordance with its or their terms to the maximum extent of the coverage available for any such director, manager, partner, officer, employee, agent or trustee under such policy or policies. If, at the time of the receipt of a notice of a claim pursuant to the terms hereof, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies.

 

9
 

(c) In the event of any payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights.

(d) The Company’s obligation to provide indemnification or advancement hereunder to Indemnitee who is or was serving at the request of the Company as a director, manager, partner, officer, employee, agent or trustee of any other Enterprise shall be reduced by any amount Indemnitee has actually received as indemnification or advancement from such other Enterprise.

Section 14. Duration of Agreement . This Agreement shall continue until and terminate upon the later of: (a) ten (10) years after the date that Indemnitee shall have ceased to serve as a director of the Company or (b) one (1) year after the final termination of any Proceeding, including any appeal, then pending in respect of which Indemnitee is granted rights of indemnification or advancement hereunder and of any proceeding commenced by Indemnitee pursuant to Section 12 of this Agreement relating thereto. This Agreement shall be binding upon the Company and its successors and assigns and shall inure to the benefit of Indemnitee and his or her heirs, executors and administrators. The Company shall require and cause any successor (whether direct or indirect by purchase, merger, consolidation or otherwise) to all, substantially all or a substantial part, of the business and/or assets of the Company, by written agreement in form and substance satisfactory to Indemnitee, expressly to assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place.

Section 15. Severability . If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable for any reason whatsoever: (a) the validity, legality and enforceability of the remaining provisions of this Agreement (including, without limitation, each portion of any section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby and shall remain enforceable to the fullest extent permitted by law; (b) such provision or provisions shall be deemed reformed to the extent necessary to conform to applicable law and to give the maximum effect to the intent of the parties hereto; and (c) to the fullest extent possible, the provisions of this Agreement (including, without limitation, each portion of any section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested thereby.

 

10
 

Section 16. Enforcement .

 

(a) The Company expressly confirms and agrees that it has entered into this Agreement and assumed the obligations imposed on it hereby in order to induce Indemnitee to serve, or continue to serve, as a director of the Company, and the Company acknowledges that Indemnitee is relying upon this Agreement in serving as a director of the Company.

(b) This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof; provided , however , that this Agreement is a supplement to and in furtherance of the Organizational Documents and applicable law, and shall not be deemed a substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder.

Section 17. Modification and Waiver . No supplement, modification or amendment, or waiver of any provision, of this Agreement shall be binding unless executed in writing by the parties thereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions of this Agreement nor shall any waiver constitute a continuing waiver. No supplement, modification or amendment of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee prior to such supplement, modification or amendment.

 

Section 18. Notice by Indemnitee . Indemnitee agrees promptly to notify the Company in writing upon being served with any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding or matter which may be subject to indemnification, reimbursement or advancement as provided hereunder. The failure of Indemnitee to so notify the Company shall not relieve the Company of any obligation which it may have to Indemnitee under this Agreement or otherwise.

 

Section 19. Notices . All notices, requests, demands and other communications under this Agreement shall be in writing and shall be deemed to have been duly given if (i) delivered by hand and receipted for by the party to whom said notice or other communication shall have been directed, (ii) mailed by certified or registered mail with postage prepaid, on the third (3 rd ) business day after the date on which it is so mailed, (iii) mailed by reputable overnight courier and receipted for by the party to whom said notice or other communication shall have been directed or (iv) sent by facsimile or e-mail transmission, with receipt of oral confirmation that such transmission has been received:

 

(a) If to Indemnitee, at such address as Indemnitee shall provide to the Company.

(b) If to the Company to:

 

Anika Therapeutics, Inc.

32 Wiggins Avenue

Bedford, Massachusetts 01730

Attention: Chief Financial Officer
Fax: (781) 305-9720
E-Mail: scheung@anikatherapeutics.com

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or to any other address as may have been furnished to Indemnitee by the Company.

 

Section 20. Contribution . To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailable to Indemnitee for any reason whatsoever, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amount incurred by Indemnitee, whether for judgments, fines, penalties, excise taxes, amounts paid or to be paid in settlement and/or for Expenses, in connection with any Proceeding in such proportion as is deemed fair and reasonable in light of all of the circumstances in order to reflect (i) the relative benefits received by the Company and Indemnitee in connection with the event(s) and/or transaction(s) giving rise to such Proceeding; and/or (ii) the relative fault of the Company (and its directors, officers, employees and agents) and Indemnitee in connection with such event(s) and/or transactions.

 

Section 21. Internal Revenue Code Section 409A . The Company intends for this Agreement to comply with the Indemnification exception under Section 1.409A-1(b)(10) of the regulations promulgated under the Internal Revenue Code of 1986, as amended (the “ Code ”), which provides that indemnification of, or the purchase of an insurance policy providing for payments of, all or part of the expenses incurred or damages paid or payable by Indemnitee with respect to a bona fide claim against Indemnitee or the Company do not provide for a deferral of compensation, subject to Section 409A of the Code, where such claim is based on actions or failures to act by Indemnitee in his capacity as a service provider of the Company. The parties intend that this Agreement be interpreted and construed with such intent.

 

Section 22. Applicable Law and Consent to Jurisdiction . This Agreement and the legal relations between the parties shall be governed by, and construed and enforced in accordance with, the laws of the Commonwealth of Massachusetts, without regard to its conflict of laws rules. Except with respect to any arbitration commenced by Indemnitee pursuant to Section 12(a) of this Agreement, the Company and Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Business Litigation Session of the Massachusetts Superior Court (the “ Massachusetts Court ”), and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of the Massachusetts Court for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) consent to service of process at the address set forth in Section 19 of this Agreement with the same legal force and validity as if served upon such party personally within the Commonwealth of Massachusetts, (iv) waive any objection to the laying of venue of any such action or proceeding in the Massachusetts Court, and (v) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in the Massachusetts Court has been brought in an improper or inconvenient forum.

 

Section 23. Headings . The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement or to affect the construction thereof.

 

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Section 24. Identical Counterparts . This Agreement may be executed in one or more counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement. Only one such counterpart signed by the party against whom enforceability is sought needs to be produced to evidence the existence of this Agreement.

 

[Remainder of Page Intentionally Left Blank]

 

 

 

 

 

 

 

 

 

 

 

 

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IN WITNESS WHEREOF, the parties have caused this Agreement to be signed as of the day and year first above written.

 

 

 

  ANIKA THERAPEUTICS, INC.
     
     
  By:  
    Name:
    Title:
     
     
     
    [Name of Indemnitee]

 

 

 

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Exhibit A

 

Form of Undertaking

 

[Date]

 

Anika Therapeutics, Inc.

32 Wiggins Avenue

Bedford, Massachusetts 01730

 

Re: Request for Advancement of Expenses

 

Ladies and Gentlemen:

 

Reference is made to the Indemnification Agreement (the “ Agreement ”) by and between Anika Therapeutics, Inc. (the “ Company ”) and the undersigned, ________ (“ Indemnitee ”). Capitalized terms not defined herein shall have those meanings as set forth in the Agreement. Pursuant to Section 8 of the Agreement, Indemnitee hereby requests advancement of Expenses incurred as a result of Indemnitee being, or being threatened to be made, a party in the following Proceeding(s): _________________________________.

 

In accordance with Section 8 of the Agreement, Indemnitee hereby:

 

(1) affirms [his/her] good faith belief that [he/she] has met the relevant standard of conduct described in Section 8.51 of the Massachusetts Business Corporation Act (“MBCA”) or the Proceeding involves conduct for which liability has been eliminated under a provision of the Company’s articles of organization as authorized by Section 2.02(b)(4) of the MBCA; and

 

(2) undertakes to repay the advancement of Expenses if [he/she] is not entitled to mandatory indemnification under Section 8.52 of the MBCA and it is ultimately determined that [he/she] has not met the relevant standard of conduct described in Section 8.51 of the MBCA.

 

Very truly yours,

 

___________, Indemnitee

 

 

 

 

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Exhibit 31.1

 

CERTIFICATION

 

I, Charles H. Sherwood, certify that:

 

  1. I have reviewed this report on Form 10-Q for the quarterly period ended September 30, 2014 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: November 5, 2014 /s/ CHARLES H. SHERWOOD
  Charles H. Sherwood, Ph.D.
  Chief Executive Officer
  Principal Executive Officer

Exhibit 31.2

 

CERTIFICATION

 

I, Sylvia Cheung, certify that:

 

  1.

I have reviewed this report on Form 10-Q for the quarterly period ended September 30, 2014 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:  November 5, 2014 /s/ SYLVIA CHEUNG
  Sylvia Cheung
  Chief Financial Officer
  Principal Financial Officer

Exhibit 32.1

 

Section 906 Certification

 

The undersigned officers of Anika Therapeutics, Inc. (the “Company”) hereby certify to their knowledge and in their respective capacities that the Company’s quarterly report on Form 10-Q to which this certification is attached (the “Report”), as filed with the Securities and Exchange Commission on the date hereof, fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: November 5, 2014 /s/ CHARLES H. SHERWOOD
  Charles H. Sherwood, Ph.D.
  Chief Executive Officer
  Principal Executive Officer
 

 

 

 Date: November 5, 2014 /s/ SYLVIA CHEUNG
  Sylvia Cheung
  Chief Financial Officer
  Principal Financial Officer

 

This certification shall not be deemed “filed” for any purpose, nor shall it be deemed to be incorporated by reference into any filing, under the Securities Act of 1933, as amended, or the Exchange Act.