ANIKA THERAPEUTICS Reports Second Quarter Results
....probably because they filed an ammendment to application
Business Wire - July 21, 1998 06:48
WOBURN, Mass.--(BW HealthWire)--July 21, 1998--ANIKA THERAPEUTICS, INC. (Nasdaq:ANIK) today reported that net income for the second quarter ended June 30, 1998 increased to $2,201,000, or $.20 per diluted share, compared with $337,000, or $.04 per diluted share, for the same period last year. Revenues for the second quarter rose 88 percent to $4,596,000 from $2,450,000 for the corresponding quarter in 1997.
Included in revenues for the second quarter ended June 30, 1998 was a previously announced licensing payment of $1.5 million from Anika's ORTHOVISC distributor, Zimmer, Inc., a division of Bristol-Myers Squibb Company (NYSE:BMY). The payment was in return for expanding the existing marketing agreement for Anika's ORTHOVISC product to add most European countries and Latin America.
For the six months ended June 30, 1998, net income was $2,838,000, or $.26 per diluted share, compared with $553,000, or $.06 per diluted share, for the first six months of 1997. Revenues for the year-to-date period increased 68 percent to $7,350,000 from $4,377,000 for the same period last year.
Anika also announced that it has filed an amendment to its Pre-Market Approval (PMA) application for its ORTHOVISC product. ORTHOVISC is an injectable form of hyaluronic acid for treating osteoarthritis of the knee. The amendment to the company's original PMA, filed December 31, 1997, was submitted in response to discussions with the FDA and includes further analysis of the clinical data. Under the FDA's regulations, the agency will have up to an additional 180 days to review this amendment.
"We are working closely with the FDA to provide them with all the information they require to support our application," said J. Melville Engle, president and chief executive officer. "We are committed to making ORTHOVISC available to patients in the United States in the shortest time frame possible."
Engle said the increase in product revenues for the quarter ended June 30, 1998 was primarily due to increased international sales of ORTHOVISC for the treatment of osteoarthritis of the knee and increased sales of AMVISC and AMVISC Plus for ophthalmic surgery to Bausch & Lomb Surgical.
"During the quarter ORTHOVISC was launched in Canada in conjunction with Zimmer and in Spain through Grupo Ferrer Internacional. Our partners are enthusiastic and have made significant investments in marketing and sales operations," Engle said. We anticipate that Zimmer will be launching ORTHOVISC in Europe and Latin America during the second half of 1998."
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, bio-compatible polymer found throughout the body. Anika's currently marketed products consist of ORTHOVISC for the treatment of osteoarthritis in humans and HYVISC for the treatment of equine osteoarthritis. Anika also manufactures AMVISC and AMVISC Plus, HA products used as viscoelastic supplements in ophthalmic surgery, for 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 as a result of a number of factors. The factors that might cause the Company's actual results to differ materially from those set forth in the forward-looking statements include those factors set forth under the heading "Risk Factors" in the Company's 10-KSB filed with the Securities and Exchange Commission on March 31, 1998. In particular, if the FDA requires the Company to design and complete an additional clinical trial or trials to demonstrate the efficacy of ORTHOVISC, there can be no assurance that such a trial or trials can be completed in a timely manner or at all or, if completed, that the results of such a trial or trials will be consistent with the results of the Company's previous trials or will produce data supporting the efficacy of ORTHOVISC. Even if the Company is able to successfully design and complete additional clinical trials and the results thereof support the efficacy of ORTHOVISC, there can be no assurance that the Company will receive FDA or other regulatory approval of ORTHOVISC, or that such approval will be obtained in a timely manner or without the need for additional clinical trials.
ANIKA THERAPEUTICS, INC.
Balance Sheets as of, June 30, December 31,
1998 1997
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 23,507,849 $ 22,679,820
Accounts receivable 2,742,191 1,918,293
Inventories 2,781,688 2,541,552
Prepaid expenses 621,599 610,364
Total current assets 29,653,327 27,750,029
Property and equipment 5,768,572 4,138,365
Less accumulated depreciation 3,563,822 3,325,321
Net property and equipment 2,204,750 813,044
Loan receivable due from officer 75,000 75,000
Long term deposits 196,160 111,265
Total Assets $ 32,129,237 $ 28,749,338
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 906,381 $ 967,986
Accrued expenses 960,894 1,253,154
Deferred revenue 200,000 200,000
Total current liabilities 2,067,275 2,421,140
Advance rent payment 77,192 103,912
Stockholders' equity:
Undesignated preferred stock,
$.01 par value: authorized
1,250,000 shares; no shares
issued and outstanding -- --
Common stock, $.01 par value:
authorized 30,000,000 shares;
issued and outstanding 9,955,457
shares and 9,691,091 shares,
respectively 99,554 96,911
Additional paid-in capital 34,506,105 32,156,504
Unearned stock option compensation (1,430,221) --
Accumulated deficit (3,190,668) (6,029,129)
Total stockholders' equity 29,984,770 26,224,286
Total Liabilities and
Stockholders' Equity $ 32,129,237 $ 28,749,338
ANIKA THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS (Unaudited)
Three months Six months
ended ended
June 30, June 30,
1998 1997 1998 1997
Product revenue $3,095,966 $2,350,073 $5,850,385 $4,277,423
Licensing payments 1,500,000 100,000 1,500,000 100,000
Total revenue 4,595,966 2,450,073 7,350,385 4,377,423
Cost of sales 1,564,569 1,187,798 2,908,041 2,207,211
Gross profit 3,031,397 1,262,275 4,442,344 2,170,212
Operating expenses:
Research and
development 388,531 509,142 891,510 832,257
Selling, general
and administrative 704,228 435,999 1,240,214 830,420
Total operating
expenses 1,092,759 945,141 2,131,724 1,662,677
Income from
operations 1,938,638 317,134 2,310,620 507,535
Interest income, net 318,468 29,418 610,568 59,802
Income before
income taxes 2,257,106 346,552 2,921,188 567,337
Income taxes 55,651 9,508 82,727 13,924
Net income $2,201,455 $337,044 $2,838,461 $553,413
Basic earnings per share $0.22 $0.06 $0.29 $0.09
Shares used for
computing basic EPS 9,948,095 5,052,426 9,895,082 5,020,989
Diluted earnings per
share $0.20 $0.04 $0.26 $0.06
Shares used for
computing diluted EPS 11,197,949 7,336,833 11,039,747 7,224,872
CONTACT: Anika Therapeutics, Inc.
Sean Moran, C.F.O.
(781) 932-6616, x102
or
Pondel Parsons & Wilkinson
Susan Klein, (508) 358-4315
Robert Whetstone, (310) 207-9300 |
