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Anika Therapeutics Reports Fourth Quarter Financial Results and Completion of Orthovisc Trial.


Business Editors and Health/Medical Writers

WOBURN, Mass.--(BUSINESS WIRE)--March 15, 2000

1998 and 1999 Results Restated for Revenue Recognized under

ORTHOVISC Distribution Agreement

and Adoption of Staff Accounting Bulletin 101

Anika Therapeutics therapeutics

Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry.
, Inc. (Nasdaq:ANIK ANIK Canadian COMSAT ) today reported financial results for the fourth quarter and year ended December 31, 1999. The company also announced a restatement Restatement

A revision in a company's earlier financial statements.

Notes:
The need for restating financial figures can result from fraud, misrepresentation, or a simple clerical error.
 of previously reported results of operations for fiscal 1998 and the first three quarters of 1999.

Revenue for the fourth quarter of 1999 was $3,618,000 compared with $3,403,000 (as restated) for the fourth quarter of 1998. Net income for the fourth quarter of 1999 was $368,000, or $0.04 per diluted di·lute  
tr.v. di·lut·ed, di·lut·ing, di·lutes
1. To make thinner or less concentrated by adding a liquid such as water.

2. To lessen the force, strength, purity, or brilliance of, especially by admixture.
 share, compared with $608,000 (as restated), or $0.06 per diluted share, for the same period last year. Revenue, net income and diluted per share earnings for the quarter ended December 31, 1998 were previously reported as $3,339,000, $769,000 and $.07, respectively.

Revenue for the year ended December 31, 1999 was $13,483,000 compared with $13,273,000 (as restated) for 1998. Income before cumulative adjustment for the change in accounting principle for non-refundable fees as described below for 1999 was $1,129,000, or $0.12 per share, compared with $3,752,000 (as restated), or $0.34 per diluted share, for the prior year. Revenue, net income and diluted per share earnings for the year ended December 31, 1998 were previously reported as $13,870,000, $4,349,000 and $0.40, respectively. Including the cumulative adjustment for the change in accounting principle for non-refundable fees, the net loss for 1999 was $2,496,000, or $0.26 per share. The cumulative adjustment of $3,625,000 was retroactively ret·ro·ac·tive  
adj.
Influencing or applying to a period prior to enactment: a retroactive pay increase.



[French rétroactif, from Latin
 recorded in the first quarter of 1999.

Restated Results

As a result of an informal inquiry by the Securities and exchange Commission (SEC), Anika and its independent public accountants have completed a thorough review of its revenue recognition policy for revenue received from Zimmer, Inc., a division of Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were  Co., under a distribution agreement for ORTHOVISC, Anika's osteoarthritis osteoarthritis
 or osteoarthrosis or degenerative joint disease

Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first.
 product. As a result of this review, and after consultation with the SEC, Anika has revised its revenue recognition policy for ORTHOVISC sales to Zimmer and is restating its operating results for 1998 and the first three quarters of 1999.

Under the revised revenue recognition policy, revenue will be recognized at the time of shipment to Zimmer based upon the minimum per unit price under the distribution agreement at the time of sale to Zimmer. Anika had previously recognized revenue for ORTHOVISC sales to Zimmer based upon an estimate of the average selling price The average sales price of goods or commodities. Especially used in the retail sector and technology distribution.  which would be obtained by Zimmer upon sale of the ORTHOVISC to its customers, as specified under the distribution agreement. Any additional amounts earned by Anika above the contractual minimum per unit price will be recognized when Zimmer sells the ORTHOVISC to its customers and Anika is able to determine its share of the actual per unit sales unit sales

Sales measured in terms of physical units rather than dollars. Unit sales data are often used by financial analysts when evaluating the health of a company.
 price. Anika had also recognized revenue in 1998 and the first three quarters of 1999 for ORTHOVISC which was held in its refrigerators at Zimmer's request. Under the company's revised revenue recognition policy, this revenue will be recorded when the ORTHOVISC is shipped to Zimmer. Amounts paid by Zimmer in excess of the amount recognized under the revised revenue recognition policy is recorded by Anika as deferred revenue and amounted to $1,420,000 at December 31, 1999.

The company has also adopted the provisions of SEC Staff Accounting Bulletin 101 (SAB SAB Spontaneous abortion. See Abortion.  101) in its restated 1999 operating results. The issuance of SAB 101 changes revenue recognition practices for non-refundable up-front payments, including $2,500,000 and $1,500,000, respectively, received from Zimmer in the fourth quarter of 1997 and the second quarter of 1998. These amounts were previously recognized in the period received. In accordance with SAB 101, the company has retroactively recorded the cumulative effect of the change in accounting principle of $3,625,000 as a charge in the first quarter of 1999. These payments will be recognized as revenue ratably over the 10-year term of the distribution agreement. The amount received and deferred to future periods is $3,225,000 at December 31, 1999 and is included in deferred revenue.

It should be noted that, under the terms of the distribution agreement, Anika has and will continue to invoice Zimmer for ORTHOVISC at the time the product is filled into sterile sterile /ster·ile/ (ster´il)
1. unable to produce offspring.

2. aseptic.


ster·ile
adj.
1. Not producing or incapable of producing offspring.

2.
 syringes, QA released and then placed into a segregated, Zimmer-only section of Anika's large refrigerated re·frig·er·ate  
tr.v. re·frig·er·at·ed, re·frig·er·at·ing, re·frig·er·ates
1. To cool or chill (a substance).

2. To preserve (food) by chilling.
 storage unit. Zimmer is then obligated ob·li·gate  
tr.v. ob·li·gat·ed, ob·li·gat·ing, ob·li·gates
1. To bind, compel, or constrain by a social, legal, or moral tie. See Synonyms at force.

2. To cause to be grateful or indebted; oblige.
 to pay Anika within 45 days.

The restatement of operating results and change in accounting principle had no effect on the company's cash position.

Operational Highlights

The company reached an important milestone during the quarter, said J. Melville Engle, chairman, president and chief executive officer, with the final patient completing the ORTHOVISC Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  on February 28, 2000. The study, which consisted of 385 patients with osteoarthritis of the knee, was conducted with leading rheumatologists and orthopedic orthopedic /or·tho·pe·dic/ (-pe´dik) pertaining to the correction of deformities of the musculoskeletal system; pertaining to orthopedics.  surgeons at 22 centers in the U.S. and Canada. Patients enrolled in the study were followed out to six months following the treatment regimen regimen /reg·i·men/ (rej´i-men) a strictly regulated scheme of diet, exercise, or other activity designed to achieve certain ends.

reg·i·men
n.
1.
 of three injections over a two-week period.

"We were pleased to see patient drop out rates in the study to be within our internal expectations. Other data from the trial will continue to be blinded until the statistical analysis is completed. According to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 the study protocol, neither physicians nor patients know whether patients were treated with injections of ORTHOVISC or a saline saline /sa·line/ (sa´len) (sa´lin) salty; of the nature of a salt; containing a salt or salts.

normal saline , physiological saline physiologic saline solution.
 control," Engle said. "The next phase in this process is to have our contract research organization collect and validate the clinical data and to prepare it for independent statistical analysis. If the clinical data are positive, we plan to submit a pre-market approval (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
) application with the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) later this year."

The company incurred approximately $700,000 and $2,100,000, respectively, in expenses primarily related to the clinical trial during the quarter and full year of 1999.

In other events at the company, Engle said Scott P. Bruder, Anika's vice president, research and development, accepted a senior position with DePuy, Inc., a Johnson & Johnson company. Bruder continues his affiliation with Anika as a member of its scientific advisory board and will be available to assist with ORTHOVISC data interpretation and the FDA application.

A conference call will be held today at 11:00 a.m. Eastern Standard Time at which management will discuss the quarter's results. To participate, please call 888-813-7836 five to 10 minutes prior to the start of the call.

About Anika Therapeutics

Anika Therapeutics, Inc. (www.anikatherapeutics.com) develops, manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing of bone, cartilage cartilage (kär`təlĭj), flexible semiopaque connective tissue without blood vessels or nerve cells. It forms part of the skeletal system in humans and in other vertebrates, and is also known as gristle.  and soft tissue. These products are based on hyaluronic acid hyaluronic acid: see mucopolysaccharide.
Hyaluronic acid

A polysaccharide which is an integral part of the gel-like substance of animal connective tissue; it supposedly serves as a lubricant and shock absorbent in the joints.
 (HA), a naturally occurring, biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function.  polymer found throughout the body. In addition to ORTHOVISC(R), a treatment for osteoarthritis of the knee (not approved for sale in the U.S.), Anika markets HYVISC(R) in the U.S. for the treatment of equine equine

Any member of the ungulate family Equidae, which includes the modern horses, zebras, and asses, all in the genus Equus, as well as more than 60 species known only from fossils. Equines descended from the dawn horse (see Eohippus).
 osteoarthritis through Boehringer Ingelheim Vetmedica, Inc. and manufactures AMVISC(TM) and AMVISC(TM)Plus, HA viscoelastic Adj. 1. viscoelastic - having viscous as well as elastic properties
natural philosophy, physics - the science of matter and energy and their interactions; "his favorite subject was physics"
 products for ophthalmic ophthalmic /oph·thal·mic/ (of-thal´mik) ocular (1).

oph·thal·mic
adj.
Of or relating to the eye; ocular.


Ophthalmic
Pertaining to the eye.
 surgery, for Bausch & Lomb Surgical. Therapies currently under development include INCERT(R), a family of HA products designed to prevent post-surgical adhesions Adhesions Definition

Adhesions are fibrous bands of scar tissue that form between internal organs and tissues, joining them together abnormally.
. Anika is also collaborating with Orquest, Inc. to manufacture Ossigel(R), an injectable in·ject·a·ble
adj.
Capable of being injected. Used of a drug.

n.
A drug or medicine that can be injected.
 formulation of basic fibroblast growth factor Basic fibroblast growth factor, also known as bFGF or FGF2, is a member of the fibroblast growth factor family.

In normal tissue, basic fibroblast growth factor is present in basement membranes and in the subendothelial extracellular matrix of blood
 combined with HA designed to accelerate the healing of bone fractures Fractures Definition

A fracture is a complete or incomplete break in a bone resulting from the application of excessive force.
Description
.

The statements made in this press release which are not statements of historical fact are forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 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 any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors, which include the following, among others. In particular there can be no assurance that the Company and/or Zimmer will obtain European or other reimbursement Reimbursement

Payment made to someone for out-of-pocket expenses has incurred.
 approvals or if such approvals are obtained they will be obtained on a timely basis or at a satisfactory level of reimbursement. In addition, there can be no assurance that the results of the ORTHOVISC(R) clinical trial will produce data supporting the efficacy of ORTHOVISC. Even if the results of the Company's clinical trials are validated and support the efficacy of ORTHOVISC, there can be no assurance that the Company will: (i) submit a pre-market approval application in a timely manner or at all or (ii) receive FDA or other regulatory approvals of ORTHOVISC or that such approvals will be obtained in a timely manner or without the need for additional clinical trials. In addition, there can be no assurance that any delay in receiving any such approvals will not adversely effect the Company's competitive position. Furthermore, there can be no assurance that Zimmer will place additional orders in 2000 or that Zimmer will not terminate the distribution agreement. 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 "Risk Factors and Certain Factors Affecting Future Operating Results" and "Management's Discussion and Analysis Management's discussion and analysis (MD&A)

A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial
" in the Company's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 filed with the SEC on March 31, 1999 as well as those described in the Company's other SEC filings for 1999.


STATEMENTS  OF  OPERATIONS

                     Three months ended       Twelve months ended
                        December 31,               December 31,
                     1999         1998          1999          1998
                             (As Restated)              (As Restated)
                        (Unaudited)

Product revenue  $ 3,518,316  $ 3,402,581  $ 13,082,662  $ 11,773,343
Licensing
  payments           100,000         --         400,000     1,500,000
 Total revenue     3,618,316    3,402,581    13,482,662    13,273,343
Cost of sales      1,613,694    1,904,867     6,440,166     6,014,181
 Gross profit      2,004,622    1,497,714     7,042,496     7,259,162
Operating
 expenses:
 Research and
  development      1,328,563      571,495     4,154,479     1,955,940
 Selling,
  general and
  administrative     764,029      621,700     3,029,394     2,731,142
  Total
   operating
   expenses        2,092,592    1,193,195     7,183,873     4,687,082
    Income (loss)
     from
     operations      (87,970)     304,519      (141,377)    2,572,080
Interest income,
 net                 464,137      329,671     1,302,063     1,307,825
    Income before
     income taxes    376,167      634,190     1,160,686     3,879,905
Income taxes           7,721       25,829        31,412       127,557
    Income before
     cumulative
     effect of
     change in
     accounting
     principle       368,446      608,361     1,129,274     3,752,348
Cumulative effect
 of change in
 accounting
  principle             --           --      (3,625,000)         --
    Net income
     (loss)       $  368,446   $  608,361  ($ 2,495,726) $  3,752,348

Basic earnings
 (loss) per share:
  Income before
   cumulative
   effect of
   change in
   accounting
   principle     $      0.04  $      0.06  $       0.12  $       0.38
  Cumulative
   effect
   of change in
   accounting
   principle            0.00         0.00         (0.38)         0.00
  Net income
  (loss)         $      0.04  $      0.06  ($      0.26) $       0.38

Shares used for
 computing basic
 EPS               9,941,901    9,791,461     9,740,560     9,885,587

Diluted earnings
 (loss) per
  share:
  Income before
   cumulative
   effect of
   change in
   accounting
   principle     $      0.04  $      0.06  $       0.12  $       0.34
  Cumulative
   effect of
   change in
   accounting
   principle            0.00         0.00         (0.38)         0.00
  Net income
   (loss)        $      0.04  $      0.06  ($      0.26) $       0.34

Shares used for
 computing
 diluted  EPS     10,305,481   10,564,628     9,740,560    11,006,139



Anika Therapeutics, Inc.

Balance Sheets as of,                   December 31,    December 31,
                                            1999            1998
                                                       (As Restated)
ASSETS

Current assets:
  Cash and cash equivalents            $  6,440,705    $ 10,712,520
  Short-term investments                  8,184,870      12,007,503
  Accounts receivable                     2,106,452       3,032,737
  Inventories                             5,493,701       3,522,019
  Prepaid expenses                          721,206         250,023
          Total current assets           22,946,934      29,524,802

Property and equipment                    8,116,233       6,376,405
Less accumulated depreciation             4,587,692       3,809,723
          Net property and equipment      3,528,541       2,566,682

  Long-term investments                   5,558,029            --
  Notes receivable from officers            353,000         193,000
  Long term deposits                        124,600         108,500
          Total Assets                 $ 32,511,104    $ 32,392,984

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:
  Accounts payable                     $    629,080    $    891,493
  Accrued expenses                        1,552,661       1,356,586
  Deferred revenue                        4,617,505         796,368
          Total current liabilities       6,799,246       3,044,447

Advance rent payment                           --            50,215

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  9,991,943 shares,
   respectively                              99,919          99,919
  Additional paid-in capital             31,959,316      34,439,676
  Deferred compensation                    (615,001)     (1,074,699)
  Treasury stock, (at cost)
   200,863 and 344,500 shares,
   respectively                            (959,870)     (1,889,794)
  Accumulated deficit                    (4,772,506)     (2,276,780)
    Total stockholders' equity           25,711,858      29,298,322
    Total Liabilities and
     Stockholders' Equity              $ 32,511,104    $ 32,392,984
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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