-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RCcnETUmvcon+laEyyBMGNJ7z1LXK4mFCtANTFJEswpIzfXyJseXdb1s+RuQJcSv bVb65Ey/N6Y+Azv/byj8Sg== 0001157523-07-011566.txt : 20071121 0001157523-07-011566.hdr.sgml : 20071121 20071121172234 ACCESSION NUMBER: 0001157523-07-011566 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071116 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Termination of a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071121 DATE AS OF CHANGE: 20071121 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANIKA THERAPEUTICS INC CENTRAL INDEX KEY: 0000898437 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 043145961 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14027 FILM NUMBER: 071264008 BUSINESS ADDRESS: STREET 1: 236 WEST CUMMINGS PARK CITY: WOBURN STATE: MA ZIP: 01801 BUSINESS PHONE: 6179326616 MAIL ADDRESS: STREET 1: 236 WEST CUMMINGS PARK CITY: WOBURN STATE: MA ZIP: 01801 FORMER COMPANY: FORMER CONFORMED NAME: ANIKA RESEARCH INC DATE OF NAME CHANGE: 19930309 8-K 1 a5552649.txt ANIKA THERAPEUTICS, INC. 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): November 16, 2007 Anika Therapeutics, Inc. - -------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in Charter) Delaware 000-21326 04-3145961 - -------------------------------------------------------------------------------- (State of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 32 Wiggins Avenue, Bedford, MA 01730 - -------------------------------------------------------------------------------- (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code: (781) 457-9000 ---------------------------- 160 New Boston Street, Woburn, Massachusetts 01801 - -------------------------------------------------------------------------------- (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: [_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [_] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [_] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [_] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Section 1 - Registrant's Business and Operations Item 1.01. Entry Into a Material Definitive Agreement. Item 1.02. Termination of a Material Definitive Agreement. On November 16, 2007, Anika Therapeutics, Inc. (the "Company") agreed to terminate the License and Development Agreement (the "License Agreement") with Galderma Pharma S.A., a joint venture between Nestle and L'Oreal ("Galderma"), and the Supply Agreement (together with the License Agreement, the "Agreements") with Galderma and Galderma S.A., an affiliate of Galderma for the exclusive worldwide development and commercialization of hyaluronic acid based cosmetic tissue augmentation ("CTA") products. Both Agreements were entered into on June 30, 2006. Pursuant to the Agreements, Anika was responsible for the development and manufacturing of the CTA products, and Galderma was responsible for the commercialization, including distribution and marketing, of the CTA products worldwide. The Company and Galderma mutually agreed to the termination of the Agreements. Under the terms of the Agreements, the Company received an upfront payment of $1 million. The Agreements also set forth milestone events related to final regulatory approvals of the CTA products in the United States and Europe, respectively, that entitled the Company to aggregate milestone payments of up to $5 million for the initial CTA product (of which $3.5 million was received) and up to an additional $1.5 million for each additional CTA product that the parties agreed to develop and market. In addition, the Agreements would have provided the Company with transfer payments for supplying Galderma with the CTA products and royalties based on sales of the Company's CTA products by Galderma to its customers. The Agreements also provided for a number of additional milestone payments of up to $14.5 million if CTA product net sales exceed certain net sales targets. Under the terms of the Agreements, Galderma would have supported the development of the Company's CTA products, including reimbursement for certain development costs for the enhancement of the initial CTA product, line extensions and clinical trial support, and the Company was responsible for obtaining regulatory approvals. The Agreements had an initial term of ten years, unless earlier terminated pursuant to any one of several early termination rights of each party or renewed. To terminate the Agreements, on November 16, 2007, the Company, Galderma and Galderma S.A. entered into a Termination Agreement (the "Termination Agreement"). Pursuant to the Termination Agreement, the Company will reacquire worldwide control of the future development and marketing of ELEVESS, the brand name of the Company's CTA products, and pay Galderma $4,250,000 for the worldwide rights and ownership of the ELEVESS trademark and all related packaging, marketing and promotional materials, as well as the clinical studies, marketing research and training materials developed by Galderma. The Termination Agreement contains mutual covenants and indemnifications that clarify the post-termination rights and obligations of the parties and is subject to certain closing conditions. The foregoing description of the Agreements and the Termination Agreement does not purport to be complete and is qualified in its entirety by reference to the text of such agreements, which, in the case of the Agreements, have been previously filed with the Securities and Exchange Commission, or, in the case of the Termination Agreement, will be filed with the Company's Annual Report on Form 10-K for the year ending December 31, 2007. The Company issued a press release concerning the Termination Agreement, which is attached hereto as Exhibit 99.1. Section 9 - Financial Statements and Exhibits Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description - ------------- ----------------------------------------------------------------- 99.1 Press Release issued by Anika Therapeutics, Inc. on November 20, 2007 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. November 21, 2007 By: /s/ KEVIN W. QUINLAN ------------------------------------- Kevin W. Quinlan Chief Financial Officer (Principal Financial Officer) Exhibit Index Exhibit No. Description - ------------- ----------------------------------------------------------------- 99.1 Press Release issued by Anika Therapeutics, Inc. on November 20, 2007 EX-99.1 2 a5552649ex99-1.txt EXHIBIT 99.1 Exhibit 99.1 Anika Therapeutics and Galderma Agree to Terminate License, Development and Supply Agreements Anika Therapeutics' to Reacquire Worldwide Rights to ELEVESS Brand BEDFORD, Mass.--(BUSINESS WIRE)--Nov. 20, 2007--Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has agreed with Galderma Pharma S.A. and Galderma S.A. (together, "Galderma") to terminate its license, development and supply agreements for the ELEVESS family of products. The agreement is subject to certain closing conditions and is expected to close before the end of November. Under the termination agreement, Anika will reacquire the worldwide control of the future development and marketing of ELEVESS. Anika will pay Galderma $4,250,000 for the worldwide rights and ownership of the "ELEVESS" trademark, and all related packaging, marketing and promotional materials, as well as the clinical studies, marketing research, and training materials developed by Galderma. The Company had previously announced that it is in negotiations to terminate the license and supply agreements with Galderma. "We believe the future is bright for ELEVESS," said Charles H. Sherwood, Ph.D., Anika's President and Chief Executive Officer. "Our product is ready for market and we want to proceed expeditiously toward commercialization. With an enhanced product that now is approved in the United States, the European Union and Canada, we would like to launch the product as soon as possible in 2008 with a new partner or initially on our own. There already has been considerable interest expressed by new potential partners, which we are pursuing. In the meantime, Anika sponsored pre-launch activities continue including reaching out to opinion leaders." About ELEVESS ELEVESS is the first injectable soft-tissue filler for facial wrinkles, scar remediation and lip augmentation to incorporate lidocaine, a local anesthetic that improves patient comfort and satisfaction and provides physicians with a new alternative for their aesthetic practice. Designed for longer durability based on its new proprietary cross-linking technology and its higher concentration of Anika's chemically modified hyaluronic acid (HA), ELEVESS has been approved for sale in the United States, the European Union and Canada. About Anika Therapeutics, Inc. Headquartered in Bedford, Mass., Anika Therapeutics, Inc. 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. Anika's products include ORTHOVISC(R), a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek; HYVISC(R), a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc.; the ELEVESS(TM) family of aesthetic dermatology products for facial wrinkles, scar remediation and lip augmentation; AMVISC(R), AMVISC(R) Plus, STAARVISC(TM)-II and Shellgel(TM) injectable viscoelastic HA products for ophthalmic surgery; INCERT(R), an HA-based anti-adhesive for surgical applications; and next generation products for joint health and aesthetic dermatology based on the Company's proprietary, chemically modified HA. The statements made in this press release which are not statements of historical fact are 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, without limitation, statements that may be identified by words such as "expectations," "remains," "focus," "expected," "prospective," "expanding," "building," "continue," "progress," "plan," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," "expect" and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. These statements also include: (i) the Company's expectations regarding its cosmetic dermatology product, ELEVESS, including statements concerning the market for ELEVESS, anticipated product launch and potential partners, and (ii) statements concerning Galderma and ELEVESS. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties and other factors. The Company's actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors including: (i) the risk that the termination agreement between the Company and Galderma does not close and the Company does not reacquire all rights to the ELEVESS family of products; (ii) the Company's ability to license ELEVESS to a new distribution partner on terms favorable to the Company, if at all; (iii) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain clinical data to support a pre-market approval application and/or FDA approval, and/or receive FDA or other regulatory approvals of its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (iv) the Company's research and product development efforts and their relative success, including whether the Company has any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of our manufacturing operations and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas or (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated. Any delay in receiving any regulatory approvals may adversely affect the Company's competitive position. Even if regulatory approvals are obtained, there is a risk that meaningful sales of the products may not be achieved. There is also a risk that (i) the Company's existing distributors (including its distributor in Turkey) or customers will not continue to place orders at historical levels or that any of them will seek to modify or terminate existing arrangements, (ii) the Company's efforts to enter into long-term marketing and distribution arrangements, including with new international distributors for ORTHOVISC, will not be successful, (iii) new distribution arrangements will not result in meaningful sales of the Company's products, (iv) the Company will be unable to achieve performance and sales threshold milestones in its distribution agreements, (v) competitive products will adversely impact the Company's product sales, (vi) the estimated size(s) of the markets which the Company has targeted its products will fail to be achieved, (vii) lack of adequate coverage and reimbursement provided by governments and other third party payers for our products and services, including non-reimbursement of ORTHOVISC in Turkey, could have a material adverse effect on our results of operations, or (viii) increased sales of the Company's products, including HYVISC(R), ORTHOVISC , or its ophthalmic products, will not continue or sales will decrease or not reach historical sales levels, or even if such increases occur that such increases will improve gross margins, any of which may have a material adverse effect on the Company's business and operations. There can be no assurance that the Company will license ELEVESS to a new distribution partner on terms favorable to the Company or at all. Certain other factors that might cause the Company's actual results to differ materially from those in the forward-looking statements include those set forth under the headings "Business," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in each of the Company's Annual Report on Form 10-K for the year ended December 31, 2006 and on Form 10-Q for the period ended September 30, 2007, as well as those described in the Company's other press releases and SEC filings. CONTACT: Anika Therapeutics, Inc. Charles H. Sherwood, 781-457-9000 Ph.D., CEO or Kevin W. Quinlan, 781-457-9000 CFO -----END PRIVACY-ENHANCED MESSAGE-----