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Biotech / Medical : anika research(anik) -- Ignore unavailable to you. Want to Upgrade?


To: chirodoc who wrote (100)2/24/1998 9:47:00 AM
From: Jon Nunley  Read Replies (1) | Respond to of 328
 
Anika Therapeutics Reports 1997 Year-End Results

Company Records First Year of Profitability

Tuesday February 24, 6:30 am Eastern Time

Company Press Release

WOBURN, Mass.--(BW HealthWire)--Feb. 24, 1998--Anika Therapeutics (NASDAQ:ANIK - news) 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(R) 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(R) 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.

''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(R)
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(R) within the United States for the treatment of equine
osteoarthritis. Anika also manufactures AMVISC(R) and AMVISC(R) 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 formulation 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, Dec. 31, 1997 Dec. 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

-0-

ANIKA THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS (Unaudited)

Three months ended Twelve months ended
Dec. 31, Dec. 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 ($1.06)

Diluted earnings
(loss) per share $0.35 ($0.50)(a) $0.44 ($1.06)(a)

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

(a) Calculation results in antidiluted earnings per share, as
such, presentation on statement of operations reverts back to basic.



To: chirodoc who wrote (100)2/24/1998 9:48:00 AM
From: Jon Nunley  Respond to of 328
 
Anika Therapeutics Announces ORTHOVISC PMA Accepted for Filing
By FDA

FDA Advisory Panel will not be required

Tuesday February 24, 6:31 am Eastern Time

Company Press Release

WOBURN, Mass.--(BW HealthWire)--Feb. 24, 1998-- 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 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, distributed by Wyeth-Ayerst Laboratories and Hyalgan,
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 within the United States for the treatment of equine
osteoarthritis. Anika also manufactures AMVISC and AMVISC 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 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.