<PAGE>
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.
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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
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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
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EXHIBIT INDEX
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Exhibit Page
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99.1 Press Release dated February 24, 1998 5
99.2 Press Release dated February 24, 1998 9
4
<PAGE>
ANIKA News Release
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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.
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"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.
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ANIKA THERAPEUTICS, INC.
<TABLE>
<CAPTION>
Balance Sheets as of, December 31, 1997 December 31, 1996
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<S> <C> <C>
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
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Total current assets 27,750,029 6,031,852
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Property and equipment 4,138,365 3,865,330
Less accumulated depreciation 3,325,321 3,046,286
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Net property and equipment 813,044 819,044
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Loan receivable due from officer 75,000 --
Long term deposits 111,265 68,765
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Total Assets $28,749,338 $6,919,661
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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
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Total current liabilities 2,421,140 1,805,548
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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)
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Total stockholders' equity 26,224,286 2,368,811
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Total Liabilities and Stockholders' Equity $28,749,338 $6,919,661
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</TABLE>
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ANIKA THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS (Unaudited)
<TABLE>
<CAPTION>
Three months ended Twelve months ended
December 31, December 31,
1997 1996 1997 1996
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<S> <C> <C> <C> <C>
Product revenue $3,443,615 $1,003,208 $9,255,338 $4,633,743
Licensing payments 2,550,000 -- 2,700,000 --
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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
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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
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Total operating expenses 1,301,437 2,293,143 4,050,263 4,882,280
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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 --
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Net income (loss) $3,058,521 $(2,359,603) $3,344,437 $(4,599,220)
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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
--------- --------- --------- ---------
</TABLE>
* Calculation results in antidiluted earnings per share, as such,
presentation on statement of operations reverts back to basic.
<PAGE>
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-
<PAGE>
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.
