-----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, Dlol4YiEDfz68AVnfLHnQvN92A1VaA4pWcCYlaHlqPGSaHwoyUmUSsjSkgOoIp0T tQeDvoFMhBTLeCJ9mUn4uA== 0001047469-98-007613.txt : 19980226 0001047469-98-007613.hdr.sgml : 19980226 ACCESSION NUMBER: 0001047469-98-007613 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19980224 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19980225 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANIKA THERAPEUTICS INC CENTRAL INDEX KEY: 0000898437 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 043145961 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-21326 FILM NUMBER: 98549448 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 8-K 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) February 24, 1998 ANIKA THERAPEUTICS, INC. (Exact name of registrant as specified in charter) Massachusetts (State or Other Jurisdiction of Incorporation) 000-21326 04-3145961 (Commission file number) (IRS employer identification number) 236 West Cummings Park, Woburn, Massachusetts 01801 (Address of principal executive offices) (Zip code) (781) 932-6616 (Registrant's telephone number, including area code) Anika Research, Inc. (Former Name) This document contains a total of 10 pages, including exhibits. Item 5. Other Events On February 24, 1998, the Board of Directors of Anika Therapeutics, Inc. (the "Company") announced its year-end results for the fiscal year ended December 31, 1997. A copy of the press release announcing the year-end results is attached hereto as Exhibit 99.1 and is incorporated by reference herein. The Company also announced that it has received notification from the U.S. Food and Drug Administration's Center for Devices and Radiological Health (the "FDA") that the Company's application for Pre-Market Approval ("PMA") for its ORTHOVISC-Registered Trademark- therapy for the treatment of osteoarthritis of the knee has been accepted for filing, with a filing date of December 31, 1997. In addition, the notification stated that the FDA will not refer the PMA to the Orthopedic and Rehabilitation Advisory Panel for review and recommendation. A copy of the press release announcing the acceptance of the Company's PMA is attached hereto as Exhibit 99.2 and is incorporated by reference herein. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits Exhibit 99.1. Press Release issued by the Company on February 24, 1998. Exhibit 99.2. Press Release issued by the Company on February 24, 1998. 2 SIGNATURE 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 hereunto duly authorized. ANIKA THERAPEUTICS, INC. Date: February 25, 1998 By: /s/ Sean F. Moran ------------------ Sean F. Moran Vice President of Finance and Treasurer (Principal Financial and Accounting Officer) 3 EXHIBIT INDEX ------------- Exhibit Page - ------- ---- 99.1 Press Release dated February 24, 1998 5 99.2 Press Release dated February 24, 1998 9 4 EX-99.1 2 EXHIBIT 99.1 ANIKA News Release - ------------------------------------------------------------------------------- FOR IMMEDIATE RELEASE - --------------------- Contact: Anika Therapeutics, Inc. Pondel Parsons & Wilkinson Sean Moran, C.F.O. Susan Klein, (508) 358-4315 (781) 932-6616, x102 Robert Whetstone, (310) 207-9300 ANIKA THERAPEUTICS REPORTS 1997 YEAR-END RESULTS Company records first year of profitability WOBURN, MASSACHUSETTS, February 24, 1998 (NASDAQ:ANIK) . . . ANIKA THERAPEUTICS, INC. today reported record sales and its first year of profitability for the year ended December 31, 1997. Net income for 1997 was $3,344,000, or $0.44 per diluted share, versus a net loss of $4,599,000, or $1.06 per diluted share for 1996. Annual revenue for the year increased 158 percent to $11,955,000 from $4,634,000 for the prior year. For the fourth quarter ended December 31, 1997, net income was $3,059,000, or $0.35 per diluted share, compared with a net loss of $2,360,000, or $0.50 per diluted share, for the final quarter of 1996. Revenues for the quarter rose to $5,994,000 from $1,003,000 for the same period last year. Included in the fourth quarter results are the shipment of $1.0 million of backlogged orders and a $2.5 million licensing payment received from Zimmer, Inc., a subsidiary of Bristol-Myers Squibb. In November 1997, the company signed an exclusive multi-year marketing and distribution agreement with Zimmer for Anika's ORTHOVISC-registered trademark- osteoarthritis treatment. As part of the agreement, Anika could potentially receive an additional $20.5 million from Zimmer contingent upon achieving certain regulatory and sales milestones. Also contributing to revenue and income growth for the current year was the commencement on January 1, 1997 of a new five year AMVISC-registered trademark- supply contract with Chiron Vision, a division of Bausch & Lomb Surgical and increased international sales of ORTHOVISC. The company ended the year with cash and cash equivalents of $22.7 million, an increase of $20.0 million from the prior year, primarily attributable to a secondary equity offering completed in the fourth quarter of 1997 which raised a net amount of approximately $17 million. - more "This was a year of major accomplishment and significant growth," said J. Melville Engle, president and chief executive officer. ""In addition to our agreement with Zimmer, we completed a pivotal U.S. clinical trial for ORTHOVISC and filed a Pre-Market Approval application with the Food and Drug Administration. We completed a preclinical trial of our INCERT-Registered Trademark- product designed to prevent post-surgical adhesions. We also executed our strategy of deploying our ultra-pure, biocompatible hyaluronic acid as a delivery vehicle by signing an exclusive manufacturing agreement with Orquest, Inc. to formulate and produce OSSIGEL-TM-." "From a financial perspective, we recorded profits from operations exclusive of the licensing payment received from Zimmer. Additionally, our cash position has been strengthened considerably. The funds raised from the secondary offering will assist us in financing the expansion of our manufacturing operations and the development of our product pipeline," Engle said. Subsequent to year end, Anika entered into an agreement with a team of physicians at the New York Center for Voice and Swallowing Disorders at Roosevelt/St. Luke's Hospital. Under the agreement, Anika will collaborate with the team to investigate the use of a hyaluronic acid formulation to protect vocal anatomy during surgery. Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products and devices intended to promote the protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika currently markets ORTHOVISC outside the United States for the treatment of osteoarthritis in humans and HYVISC-Registered Trademark- within the United States for the treatment of equine osteoarthritis. Anika also manufactures AMVISC-Registered Trademark- and AMVISC-Registered Trademark- Plus, HA products used as viscoelastic supplements in ophthalmic surgery for Chiron Vision, a division of Bausch & Lomb Surgical. Therapies currently under development include INCERT, an HA product designed to prevent post-surgical adhesions and HA oligosaccharides for the treatment of cancer. Anika is also collaborating with Orquest, Inc. to manufacture OSSIGEL, an injectable formation of basic fibroblast growth factor combined with HA designed to accelerate the healing of bone fractures. Balance Sheets and Statements of Operations for the Company are attached. ### This press release includes forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company's actual results could differ materially from those set forth in the forward-looking statements. Certain factors that might cause such a difference are set forth as Risk Factors in the Company's Final Prospectus filed with the Securities and Exchange Commission on November 25, 1997. ANIKA THERAPEUTICS, INC.
Balance Sheets as of, December 31, 1997 December 31, 1996 - ------------------------------------------------------------------------------------------------------ ASSETS Current assets: Cash and cash equivalents $22,679,820 $2,704,665 Accounts receivable 1,918,293 539,004 Inventories 2,541,552 2,481,646 Prepaid expenses 610,364 306,537 - ------------------------------------------------------------------------------------------------------ Total current assets 27,750,029 6,031,852 - ------------------------------------------------------------------------------------------------------ Property and equipment 4,138,365 3,865,330 Less accumulated depreciation 3,325,321 3,046,286 - ------------------------------------------------------------------------------------------------------ Net property and equipment 813,044 819,044 - ------------------------------------------------------------------------------------------------------ Loan receivable due from officer 75,000 -- Long term deposits 111,265 68,765 - ------------------------------------------------------------------------------------------------------ Total Assets $28,749,338 $6,919,661 - ------------------------------------------------------------------------------------------------------ - ------------------------------------------------------------------------------------------------------ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 967,986 $ 550,314 Accrued expenses 1,253,154 1,055,234 Deferred revenue 200,000 200,000 - ------------------------------------------------------------------------------------------------------ Total current liabilities 2,421,140 1,805,548 - ------------------------------------------------------------------------------------------------------ Advance rent payment 103,912 142,775 Redeemable convertible preferred stock; $.01 par value: authorized 750,000 shares; issued and outstanding no shares and 126,259 shares, respectively; liquidation and redemption value of $20.00 per share plus accrued dividends -- 2,602,527 Stockholders' equity: Undesignated preferred stock, $.01 par value: authorized 1,250,000 shares; no shares issued and outstanding -- -- Common stock, $.01 par value: authorized 15,000,000 shares; issued and outstanding 9,691,091 shares and 4,930,719 shares, respectively 96,911 49,307 Additional paid-in capital 32,156,504 11,693,070 Accumulated deficit (6,029,129) (9,373,566) - ------------------------------------------------------------------------------------------------------ Total stockholders' equity 26,224,286 2,368,811 - ------------------------------------------------------------------------------------------------------ Total Liabilities and Stockholders' Equity $28,749,338 $6,919,661 - ------------------------------------------------------------------------------------------------------ - ------------------------------------------------------------------------------------------------------
ANIKA THERAPEUTICS, INC. STATEMENTS OF OPERATIONS (Unaudited)
Three months ended Twelve months ended December 31, December 31, 1997 1996 1997 1996 - ------------------------------------------------------------------------------------------------------------- Product revenue $3,443,615 $1,003,208 $9,255,338 $4,633,743 Licensing payments 2,550,000 -- 2,700,000 -- - ------------------------------------------------------------------------------------------------------------- Total revenue 5,993,615 1,003,208 11,955,338 4,633,743 Cost of sales 1,728,171 1,113,185 4,744,123 4,517,591 - ------------------------------------------------------------------------------------------------------------- Gross profit 4,265,444 (109,977) 7,211,215 116,152 Operating expenses: Research and development 480,703 1,140,565 1,957,796 2,488,657 Selling, general and administrative 820,734 1,152,578 2,092,467 2,393,623 - ------------------------------------------------------------------------------------------------------------- Total operating expenses 1,301,437 2,293,143 4,050,263 4,882,280 - ------------------------------------------------------------------------------------------------------------- Income (loss) from operations 2,964,007 (2,403,120) 3,160,952 (4,766,128) Interest income, net (156,932) (43,517) (262,162) (166,908) Income (loss) before income taxes 3,120,939 (2,359,603) 3,423,114 (4,599,220) Income taxes 62,418 -- 78,677 -- - ------------------------------------------------------------------------------------------------------------- Net income (loss) $3,058,521 $(2,359,603) $3,344,437 $(4,599,220) - ------------------------------------------------------------------------------------------------------------- - ------------------------------------------------------------------------------------------------------------- Basic earnings (loss) per share $0.46 ($0.50) $0.60 $(1.60) ----- ------- ----- ------ Diluted earnings (loss) per share $0.35 ($0.50)* $0.44 $(1.06)* ----- ------- ----- ------ Shares used for computing basic EPS 6,656,229 4,807,581 5,436,474 4,549,233 --------- --------- --------- --------- Shares used for computing diluted EPS 8,695,028 4,807,581 7,587,393 4,549,233 --------- --------- --------- ---------
* Calculation results in antidiluted earnings per share, as such, presentation on statement of operations reverts back to basic. EX-99.2 3 EX-99.2 Exhibit 99.2 ANIKA News Release - -------------------------------------------------------------------------------- FOR IMMEDIATE RELEASE Contact: Anika Therapeutics, Inc. Pondel Parsons & Wilkinson Sean Moran, C.F.O. Susan Klein, (508) 358-4315 (781) 932-6616, x102 Robert Whetstone, (310) 207-9300 ANIKA THERAPEUTICS ANNOUNCES ORTHOVISC-Registered Trademark- PMA ACCEPTED FOR FILING BY FDA FDA Advisory Panel will not be required WOBURN, MASSACHUSETTS, February 24, 1998 (NASDAQ:ANIK)...ANIKA THERAPEUTICS, INC. today announced it has received notification from the U.S. Food and Drug Administration's Center for Devices and Radiological Health that the Company's application for Pre-Market Approval (PMA) for its ORTHOVISC-Registered Trademark- therapy for the treatment of osteoarthritis of the knee has been accepted for filing, with a filing date of December 31, 1997. In addition, the notification stated that the FDA will not refer the PMA to the Orthopedic and Rehabilitation Advisory Panel for review and recommendation. Acceptance of the application for filing means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. "Our staff worked very diligently to compile this submission, and we are doing everything in our power to satisfy the FDA's information needs regarding ORTHOVISC," said J. Melville Engle, president and chief executive officer. "We realize that this is one of several hurdles we must pass, but it was an important one and we are pleased with the outcome." Two other HA products for osteoarthritis of the knee, Synvisc-Registered Trademark-, distributed by Wyeth-Ayerst Laboratories and Hyalgan-Registered Trademark-, distributed by Sanofi Pharmaceuticals, Inc., received FDA approvals during 1997. Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products and devices intended to promote the protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid (HA), a naturally occurring biocompatible polymer found throughout the body. Anika currently markets ORTHOVISC outside the United States for the treatment of osteoarthritis in humans and HYVISC-Registered Trademark- within the United States for the treatment of equine osteoarthritis. Anika also manufactures AMVISC-Registered Trademark- and AMVISC-Registered Trademark- Plus, HA products used as viscoelastic supplements in ophthalmic surgery for Chiron Vision, a division of Bausch & Lomb Surgical. -more- Therapies currently under development include INCERT-Registered Trademark-, an HA product designed to prevent post-surgical adhesions and HA oligosaccharides for the treatment of cancer. Anika is also collaborating with Orquest, Inc. to manufacture OSSIGEL-TM-, an injectable formulation of basic fibroblast growth factor combined with HA designed to accelerate the healing of bone fractures. This press release includes forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company's actual results could differ materially from those set forth in the forward-looking statements. Certain factors that might cause such a difference include the risk that the ORTHOVISC PMA may not be approved or may be significantly delayed and those other factors are set forth as Risk Factors in the Company's Final Prospectus filed with the Securities and Exchange Commission on November 25, 1997. -----END PRIVACY-ENHANCED MESSAGE-----