-----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, AS7czpV8MCsWwK9KYFU5bHr0oxLGMfFS09Ppyac7JemHAGqzn3EA0a1NoODqy2AW RlpSk1WyntyiKRIU7KKq1g== 0001157523-07-007152.txt : 20070724 0001157523-07-007152.hdr.sgml : 20070724 20070724170657 ACCESSION NUMBER: 0001157523-07-007152 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070724 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070724 DATE AS OF CHANGE: 20070724 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: 07996802 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 a5455112.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): July 24, 2007 Anika Therapeutics, Inc. (Exact name of registrant as specified in its charter) -------------------- Massachusetts 000-21326 04-314-5961 (State or other jurisdiction of Commission file number (I.R.S. Employer incorporation or organization) Identification No.) 160 New Boston Street, Woburn, MA 01801 (Address of principal executive offices) (Zip code) Registrant's telephone number, including area code: 781-932-6616 (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 2--Financial Information Item 2.02. Results of Operations and Financial Condition. The following information, including the exhibit attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing. On July 24, 2007, Anika Therapeutics, Inc. issued a press release announcing its financial results for the second quarter and six months ended June 30, 2007. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference. Section 9--Financial Statements and Exhibits Item 9.01. Financial Statements and Exhibits. (d) Exhibits. 99.1 Press Release of Anika Therapeutics, Inc. dated July 24, 2007. [Remainder of page left blank intentionally] SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be filed on its behalf by the undersigned hereunto duly authorized. Anika Therapeutics, Inc. Dated: July 24, 2007 By: /s/ Kevin W. Quinlan ------------------------------------ Kevin W. Quinlan Chief Financial Officer Exhibit Index 99.1 Press Release of Anika Therapeutics, Inc. dated July 24, 2007 . EX-99.1 2 a5455112ex991.txt EXHIBIT 99.1 Exhibit 99.1 Anika Therapeutics Reports Second-Quarter Fiscal 2007 Financial Results ORTHOVISC Domestic Revenue Increases 66%; Product Revenue Increases 18% Sequentially WOBURN, Mass.--(BUSINESS WIRE)--July 24, 2007--Anika Therapeutics, Inc. (Nasdaq: ANIK) today reported financial results for the second quarter ended June 30, 2007. Revenue Anika reported product revenue of $6,332,000 for the second quarter of 2007 compared with $7,115,000 in the year ago period. Product revenue for the first six months of 2007 was $11,706,000 compared with $13,381,000 in the first six months of 2006. The decline in product revenue was due to the change in the Turkish government's reimbursement policy previously announced in October 2006. This resulted in a loss of ORTHOVISC(R) sales during the second half of 2006, and through May of 2007. ORTHOVISC sales in Turkey were $2.4 million and $3.8 million for the second quarter and first half of 2006, respectively. U.S. ORTHOVISC revenue increased 66% in the quarter, compared with last year's second quarter, fueled primarily by the unique reimbursement code assigned to ORTHOVISC in January and an increased number of Mitek sales specialists. Three- and six-month international sales of ORTHOVISC were lower in 2007 versus the same periods in 2006 primarily due to the impact of Turkish sales. Revenue in the ophthalmic business increased 14% in the second quarter of 2007 compared with the second quarter of 2006. Anika also reported strong HYVISC(R) revenue, which increased 215% year over year to $701,000 in the second quarter. During the three and six months ending June 30, 2007, licensing, milestone and contract revenue was $768,000 and $1,532,000, respectively, compared with $683,000 and $1,370,000 in the prior year periods. Total revenue for the second quarter of 2007 was $7,100,000 compared with $7,798,000 in the second quarter of 2006. Total revenue for the first six months of 2007 was $13,238,000 compared with $14,751,000 in the first six months of 2006. Product Gross Margin Product gross margin for the second quarter of 2007 was 52% compared with 59% in the second quarter of 2006. For the first six months of 2007, product gross margin was 53% compared with 56% for the six month period in 2006. The decline in product gross margin for both periods is due primarily to product mix and timing of orders in both years. The company currently expects product gross margin to be higher in the second half of 2007, and for the full year 2007 gross margin to be comparable to full year 2006. Operating Expenses Total operating expenses, excluding cost of product revenue, were $2,712,000 for the second quarter of 2007 compared with $3,106,000 for the second quarter of 2006. Total operating expenses, excluding cost of product revenue, for the first six months of 2007 were $5,135,000 compared with $5,972,000 for the first six months of 2006. Operating expenses for both 2007 periods were lower than their respective 2006 periods due to higher clinical trial costs incurred in 2006 related to an ELEVESS European study, as well as legal costs incurred to complete the distribution agreement signed with Galderma in mid-2006. Net Income Net income for the second quarter of 2007 was $1,365,000, or $0.12 per diluted share, compared with $1,352,000, or $0.12 per diluted share, for the same period last year. Net income for the six month period of 2007 was $2,566,000, or $0.23 per share, compared with $2,233,000, or $0.20 per diluted share, for the first six months of 2006. The modest improvement in net income resulted despite lower revenue and gross margins in both the second quarter and six month periods due to lower operating expenses, higher interest income, and a lower effective tax rate. The lower tax rate reflects higher state investment tax credits as a result of the Anika's ongoing investment in a new facility. Other Anika's cash, cash equivalents and short-term investments at June 30, 2007 were $48,267,000 compared with $47,167,000 at December 31, 2006. Second-Quarter Highlights and Outlook "The U.S. and European approval of our new cosmetic dermatology product, ELEVESS(TM), a 66% second quarter increase in U.S. ORTHOVISC revenues, rebound in ophthalmic revenue, and strong veterinary sales punctuated a successful second quarter," said Charles H. Sherwood, Ph.D., Anika's president and chief executive officer. "This contributed to second-quarter 2007 product revenue increasing 18% over the sequential first quarter." "ORTHOVISC unit sales in the U.S. more than doubled during the second quarter and first half of 2007, continuing the positive trend we saw last quarter and all of last year," added Sherwood. "We are encouraged by the response physicians are having to ORTHOVISC after the receipt of the product's new reimbursement code in January and the addition of Mitek sales specialists. Internationally, the resumption of modest shipments to Turkey should make future quarterly comparisons of ORTHOVISC sales favorable as we work to rebuild our sales outside the U.S." "Our plans for the ORTHOVISC franchise in the second half of 2007 include targeting increased sales, both domestically and internationally, by expanding our product portfolio and seeking new international distribution partners," said Sherwood. "We also are focused on receiving approval to market our first single-injection osteoarthritis product in Europe by the end of the year." "Receiving FDA approval of ELEVESS is truly a milestone achievement in our commercialization efforts with Galderma Pharma," added Sherwood. "We are now positioned to benefit from the rapid growth in the global market for cosmetic fillers and we expect Galderma to launch ELEVESS worldwide in the second half of this year." Conference Call Information The company will hold a conference call to review its financial results and business highlights on Wednesday, July 25, 2007, at 9:00 a.m. ET. In addition, the company may address during the conference call its business and financial developments and trends, including those involving product lines and business partners, and other business and financial matters affecting the company, which may contain information that has not been previously disclosed. To listen to the conference call, dial 800-901-5259 (International callers use 617-786-4514) and use the passcode 56481863. Please call approximately 10 minutes before the starting time and reference Anika Therapeutics. In addition, the conference call will be available to interested parties through a live audio Internet broadcast at www.anikatherapeutics.com. The call will be archived and accessible on the same website shortly after the conclusion of the call. About Anika Therapeutics, Inc. Headquartered in Woburn, 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.; and the ELEVESS(TM) family of cosmetic dermatology products for facial wrinkles, scar remediation and lip augmentation, which will be marketed by Galderma Pharma. Anika also develops and manufactures Amvisc(R) and Amvisc Plus(R), HA viscoelastic products for ophthalmic surgery. It also produces STAARVISC(TM)-II, which is distributed by STAAR Surgical company and Shellgel(TM) for Cytosol Ophthalmics, Inc. 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," 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 statements regarding: (i) the company's expectations regarding its cosmetic dermatology product, ELEVESS(TM), including its expectations regarding a worldwide launch by Galderma, (ii) product gross margin (iii) international sales of ORTHOVISC(R) and the impact on ORTHOVISC sales from international distribution agreements and product registrations around the world, and (iv) prospects for domestic and international ORTHOVISC sales, market approvals and clinical enrollments, and (v) statements made under the heading Second-Quarter Highlights and Outlook. 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 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; (ii) 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; (iii) the cost effectiveness and efficiency of our manufacturing operations and production planning; (iv) 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 (v) 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, including the agreement with Galderma Pharma S.A. pertaining to its ELEVESS(TM) product, 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. 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 March 31, 2007, as well as those described in the company's other press releases and SEC filings. Anika Therapeutics, Inc. and Subsidiary Consolidated Statements of Operations (unaudited) Quarter Ended Six Months Ended June 30, June 30, --------------------- ----------------------- 2007 2006 2007 2006 ---------- ---------- ----------- ----------- Product revenue $6,331,966 $7,115,484 $11,706,004 $13,381,318 Licensing, milestone and contract revenue 767,596 682,557 1,531,604 1,369,684 ---------- ---------- ----------- ----------- Total revenue 7,099,562 7,798,041 13,237,608 14,751,002 Operating expenses: Cost of product revenue 3,023,781 2,890,904 5,516,703 5,938,722 Research & development 996,051 1,129,877 1,843,392 2,206,669 Selling, general & administrative 1,716,099 1,976,600 3,291,149 3,765,599 ---------- ---------- ----------- ----------- Total operating expenses 5,735,931 5,997,381 10,651,244 11,910,990 ---------- ---------- ----------- ----------- Income from operations 1,363,631 1,800,660 2,586,364 2,840,012 Interest income, net 575,831 489,772 1,142,608 950,846 ---------- ---------- ----------- ----------- Income before income taxes 1,939,462 2,290,432 3,728,972 3,790,858 Provision for income taxes 574,611 938,367 1,163,344 1,558,043 ---------- ---------- ----------- ----------- Net income $1,364,851 $1,352,065 $2,565,628 $2,232,815 ========== ========== =========== =========== Basic net income per share: Net income $0.12 $0.13 $0.23 $0.21 Basic weighted average common shares outstanding 11,018,053 10,601,336 10,949,629 10,564,902 Diluted net income per share: Net income $0.12 $0.12 $0.23 $0.20 Diluted weighted average common shares outstanding 11,376,673 10,955,156 11,342,280 10,969,569 Anika Therapeutics, Inc. and Subsidiary Consolidated Balance Sheets (unaudited) June 30, December 31, 2007 2006 ------------ ------------ ASSETS Current assets: Cash and cash equivalents $44,751,227 $47,167,432 Short term investment 3,515,949 -- Accounts receivable, net 6,751,264 3,509,508 Inventories 5,537,691 5,395,596 Current portion deferred income taxes 1,312,901 1,312,901 Prepaid expenses and other receivables 427,665 220,445 ------------ ------------ Total current assets 62,296,697 57,605,882 Property and equipment, at cost 16,054,707 13,255,240 Less: accumulated depreciation (10,573,883) (10,237,232) ------------ ------------ 5,480,824 3,018,008 Long-term deposits and other 399,300 193,050 Deferred income taxes 7,484,459 7,296,689 ------------ ------------ Total Assets $75,661,280 $68,113,629 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable $2,616,131 $965,180 Accrued expenses 1,496,690 1,573,835 Deferred revenue 3,135,718 2,905,099 Income taxes payable 264,257 17,253 Other long-term liabilities 305,195 64,525 Long-term deferred revenue 17,499,712 17,099,712 ------------ ------------ Total liabilities 25,317,703 22,625,604 Stockholders' equity Preferred stock -- -- Common stock 111,287 107,727 Additional paid-in-capital 39,549,132 37,262,768 Retained earnings 10,683,158 8,117,530 ------------ ------------ Total stockholders' equity 50,343,577 45,488,025 ------------ ------------ Total Liabilities and Stockholders' Equity $75,661,280 $68,113,629 ============ ============ Anika Therapeutics, Inc. and Subsidiary Supplemental Financial Data - (unaudited) Product Gross Margin and Revenue by Product Line Quarter Ended June 30, -------------------------------- % % 2007 Ttl 2006 Ttl ---------- ---- ---------- ----- Ophthalmic Products $2,889,585 46% $2,545,170 36% ORTHOVISC 2,655,059 42% 4,337,094 61% HYVISC 701,172 11% 222,720 3% Other 86,150 1% 10,500 0% ---------- ---- ---------- ----- $6,331,966 100% $7,115,484 100% ========== ==== ========== ===== Product gross profit $3,308,185 $4,224,580 Product gross margin 52% 59% Product Revenue by Geography Quarter Ended June 30, -------------------------------- % % 2007 Ttl 2006 Ttl ---------- ---- ---------- ----- Domestic $4,901,224 77% $3,276,355 46% International 1,430,742 23% 3,839,129 54% ---------- ---- ---------- ----- $6,331,966 100% $7,115,484 100% ========== ==== ========== ===== Anika Therapeutics, Inc. and Subsidiary Supplemental Financial Data - (unaudited) Product Gross Margin and Revenue by Product Line Six Months Ended June 30, ---------------------------------- % % 2007 Ttl 2006 Ttl ----------- ---- ----------- ---- Ophthalmic Products $5,174,706 44% $5,482,340 41% ORTHOVISC 5,298,356 45% 6,978,518 52% HYVISC 1,130,097 10% 909,960 7% Other 102,845 1% 10,500 0% ----------- ---- ----------- ---- $11,706,004 100% $13,381,318 100% =========== ==== =========== ==== Product gross profit $6,189,301 $7,442,596 Product gross margin 53% 56% Product Revenue by Geography Six Months Ended June 30, ---------------------------------- % % 2007 Ttl 2006 Ttl ----------- ---- ----------- ---- Domestic $9,118,905 78% $7,150,472 53% International 2,587,099 22% 6,230,846 47% ----------- ---- ----------- ---- $11,706,004 100% $13,381,318 100% =========== ==== =========== ==== CONTACT: Anika Therapeutics, Inc. Charles H. Sherwood, Ph.D., 781-932-6616 CEO or Kevin W. Quinlan, 781-932-6616 CFO -----END PRIVACY-ENHANCED MESSAGE-----