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Anika Therapeutics Announces Financial Results for 2003 Second Quarter.


Business Editors

WOBURN, Mass.--(BUSINESS WIRE)--July 30, 2003

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 announced financial results for the second quarter and six-month period ended June 30, 2003.

For the second quarter, Anika posted revenues of $3,318,000, compared with $3,421,000 for the same period last year. Net loss for the quarter was reduced to $81,000, or $.01 per share, compared with a net loss of $1,157,000, or $.12 per share, for the second quarter of 2002.

Revenue for the six-month period ended June 30, 2003, increased 15% to $6,702,000 versus $5,811,000 in the comparable period last year. The net loss was $394,000, or $.04 per share, for the first six months of 2003, compared with $2,961,000, or $.30 per share, in the first six months of 2002.

"Revenue was impacted during the most recent quarter due to a drop in sales of HYVISC(R), our treatment for 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 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.
. Sales of this product to our distributors were up in the first quarter of 2003 and on a year-to-date Year-to-date (YTD)

The period beginning at the start of the calendar year up to the current date.
 basis over the same periods of 2002, reflecting an inventory replenishment replenishment

the addition of an appropriate quantity of properly prepared solution containing the correct concentration of chemicals to the developer solutions used in radiography.
 for certain units shipped without required regulatory approval in the latter part of 2002, as we previously reported," said Charles H. Sherwood, Ph.D., president and chief executive officer. "Sales of our human osteoarthritis product, ORTHOVISC Orthovisc Orthopedics An injectable hyaluronic acid for treating osteoarthritis of the knee; viscoelastic and lubricating properties are similar to normal synovial fluid. See Hyaluronic acid. (R), grew 13% in overseas markets and 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.
 sales to our distributors held steady at levels yielding 4% growth. These results, combined with our ongoing program to improve our manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations.  and reduce cost of sales, and lower research and development and other corporate expenses, translated to a significantly narrowed net loss for the second quarter as compared to the second quarter of 2002.

"We also achieved a significant milestone this quarter with the submission of the pre-market Pre-Market

Trading done before the regular market opens.

Notes:
Participation by market makers and ECNs is voluntary, so in pre-market there may be less liquidity than during normal hours of trading.
 approval application to the U.S. Food and Drug Administration for ORTHOVISC for the treatment of osteoarthritis of the knee," Sherwood said. "With that review under way, management is now focused on evaluating potential distribution partners for the commercialization of ORTHOVISC in the U.S. assuming 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.
 marketing clearance."

Gross margins for the second quarter ended June 30, 2003 rose to 44.4% from 35.7% in the same period last year, primarily underscoring the benefit of manufacturing efficiencies the company implemented last year. Similarly, gross margins for the six-month period increased to 43.1% from 26.2% as reported in the same period last year.

Research and development expenses declined 38% to $648,000 versus $1,050,000 for the second quarter of 2002. For the six-month period, research and development expenses decreased 32% to $1,457,000 compared with $2,140,000 in the comparable period last year. The decrease in these costs in the three and six-month periods was due primarily to the completion of the Phase III Noun 1. phase III - 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 FDA  pivotal clinical study of ORTHOVISC in late 2002.

Selling, general and administrative expenses for the quarter ended June 30, 2003 declined 32% to approximately $945,000 versus $1,388,000 in the comparable period last year. For the six-months ended June 30, 2003, selling, general and administrative expenses amounted to $2,060,000, as compared with $2,468,000 for the first six months of 2002.

Cash and short-term Short-term

Any investments with a maturity of one year or less.


short-term

1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time.
 investments at June 30, 2003 totaled $11.5 million compared with $13.0 million at March 31, 2003.

Conference Call Information

The company will hold a conference call to review its financial results Thursday, July 31, 2003 at 11:00 a.m. EDT EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

EDT 
. To listen to the conference call, dial 706-634-1550 approximately 10 minutes before the starting time Noun 1. starting time - the time at which something is supposed to begin; "they got an early start"; "she knew from the get-go that he was the man for her"
commencement, get-go, offset, outset, showtime, start, kickoff, beginning, first
 and reference Anika Therapeutics. In addition, the conference call will be available to interested parties through a live audio Internet Internet

Publicly accessible computer network connecting many smaller networks from around the world. It grew out of a U.S. Defense Department program called ARPANET (Advanced Research Projects Agency Network), established in 1969 with connections between computers at the
 broadcast at http://www.anikatherapeutics.com/newset.htm. The call will be archived and accessible on the same Web site for one year beginning at 2:00 p.m. EDT Thursday, July 31, 2003.

About Anika Therapeutics, Inc.

Headquartered in Woburn, Mass., Anika Therapeutics, Inc. (www.anikatherapeutics.com) develops, manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing Healing
See also Medicine.

Achilles’ spear

had power to heal whatever wound it made. [Gk. Lit.: Iliad]

Agamede

Augeas’ daughter; noted for skill in using herbs for healing. [Gk. Myth.
 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 osteoarthritis through Boehringer Ingelheim Vetmedica, Inc. and manufactures AMVISC(R) and AMVISC(R) 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 surgery, for Bausch & Lomb. It also produces STAARVISC(TM)-II for distribution by STAAR STAAR Second Time Around Aussie Rescue, Inc. (Bryan, TX)
STAAR Space Technology Applications Astronomy & Rocket Research (Scottish Rocket Programme) 
 Surgical Company and Shellgel(TM) for Cytosol cytosol /cy·to·sol/ (sit´ah-sol) the liquid medium of the cytoplasm, i.e., cytoplasm minus organelles and nonmembranous insoluble components.cytosol´ic

cy·to·sol
n.
 Ophthalmics, Inc.

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 Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements that may be identified by words such as "expectations," "remains," "focus," "expected," "prospective," "expanding," "building," "continue," "progress," "efforts," "hope," "believe," "objectives," opportunities," "will," "seek," and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. These statements also include statements regarding: (i) the Company's efforts and expectations in entering into long-term Long-term

Three or more years. In the context of accounting, more than 1 year.


long-term

1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term.
 arrangements to market and distribute ophthalmic and osteoarthritis products, (ii) the level of the Company's revenue or sales in particular geographic areas and/or for particular products, (iii) the market share of any of the Company's products, (iv) expectations regarding future results of operations, including the Company's expectations regarding cash utilization, (v) the Company's intention to strengthen, expand and grow its ophthalmic franchise and the growth of the Company's ophthalmic business, (vi) the Company's goal of obtaining FDA approval for ORTHOVISC(R), (vii) the Company's expectations of the size of the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  market for osteoarthritis of the knee, (viii) the Company's intention to increase market share for ORTHOVISC(R) in international (and, eventually, domestic) markets or otherwise penetrate growing markets for osteoarthritis of the knee, (ix) the Company's expectations for inventory turns, and (x) the Company's corporate objectives and research and development and collaboration opportunities, including, without limitation, intended commencement of INCERT INCERT Surgery Bioabsorbable, implantable sponge designed to prevent postsurgical adhesion formation. See Adhesions. (R) clinical trials. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties and other factors. 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 including: (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain clinical data to support a pre-market approval application and/or FDA approval, and/or receive FDA or other regulatory approvals of its products, including ORTHOVISC(R), or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) the success of the Company's efforts to improve the financial performance of its core business; (iii) the Company's research and product development efforts and their relative success, including whether the Company has any meaningful sales of any new products resulting from such efforts; (iv) the cost effectiveness and efficiency of our manufacturing operations and production planning Production planning

The function of a manufacturing enterprise responsible for the efficient planning, scheduling, and coordination of all production activities.
; (v) the strength of the Turkish economy in general and other economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas or (vi) future determinations by the Company to allocate To reserve a resource such as memory or disk. See memory allocation.  resources to products and in directions not presently contemplated. Any delay in receiving any regulatory approvals may adversely affect the Company's competitive position. Even if regulatory approvals are obtained, there is a risk that meaningful sales of the products may not be achieved. There is also a risk that (i) the Company's existing distributors or customers will not continue to place orders at historical levels or that any of them will seek to modify or terminate existing arrangements, (ii) the Company's efforts to enter into long-term marketing and distribution arrangements will not be successful, including enlisting a domestic distribution partner for ORTHOVISC(R), (iii) new distribution arrangements will not result in meaningful sales of the Company's products, or (iv) increased sales of the Company's products, including HYVISC(R) or its ophthalmic products, will not continue or sales will decrease or not reach historical sales levels, any of which may have a material adverse effect on the Company's business and operations. 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 "Business," "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
 of Financial Condition and Results of Operations" in each of 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.
 for the year ended December 31, 2002, its Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended March 31, 2003 and Current Reports on Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 8-K.
, as well as those described in the Company's other press releases and SEC filings.

                  Anika Therapeutics, Inc. and Subsidiaries
                    Consolidated Statements of Operations
                              (Unaudited)

                         Three Months Ended       Six Months Ended
                              June 30,                June 30,
                           2003        2002        2003        2002
                       ----------------------- -----------------------

Product revenue        $3,303,000  $3,416,000  $6,673,000  $5,801,000
License revenue            15,000       5,000      29,000      10,000
                       ----------------------- -----------------------
  Total revenue         3,318,000   3,421,000   6,702,000   5,811,000
Cost of product revenue 1,846,000   2,202,000   3,815,000   4,289,000
                       ----------------------- -----------------------
  Gross profit          1,472,000   1,219,000   2,887,000   1,522,000
Operating expenses:
  Research and
   development            648,000   1,050,000   1,457,000   2,140,000
  Selling, general and
   administrative         945,000   1,388,000   2,060,000   2,468,000
                       ----------------------- -----------------------
Total operating
 expenses               1,593,000   2,438,000   3,517,000   4,608,000
                       ----------------------- -----------------------
Loss from operations     (121,000) (1,219,000)   (630,000) (3,086,000)
  Interest income, net     40,000      62,000      82,000     125,000
                       ----------------------- -----------------------
Loss before income tax
 benefit                  (81,000) (1,157,000)   (548,000) (2,961,000)
  Income tax benefit           --          --     154,000          --
                       ----------------------- -----------------------
Net loss                 $(81,000)$(1,157,000)  $(394,000)$(2,961,000)
                       ======================= =======================

Basic and diluted net
 loss per common share     $(0.01)     $(0.12)     $(0.04)     $(0.30)
                       ======================= =======================
Shares used to
 calculate basic and
 diluted net loss per
 common share           9,941,121   9,934,280   9,937,719   9,934,280
                       ======================= =======================



              Anika Therapeutics, Inc. and Subsidiaries
                     Consolidated Balance Sheets

                                               June 30,   December 31,
                                                  2003        2002
                                              ------------------------
                    ASSETS                    (Unaudited)
Current assets:
   Cash and cash equivalents                  $11,453,000 $11,002,000
   Marketable securities                               --   2,500,000
   Accounts receivable, net                     2,105,000   1,198,000
   Inventories                                  3,228,000   2,924,000
   Prepaid expenses and other current assets      249,000     320,000
                                              ------------------------
       Total current assets                    17,035,000  17,944,000
Property and equipment, at cost                 9,752,000   9,619,000
Less:  accumulated depreciation                (8,175,000) (7,679,000)
                                              ------------------------
                                                1,577,000   1,940,000
Long-term deposits                                143,000     143,000
Notes receivable from officers                     59,000      59,000
                                              ------------------------
Total assets                                  $18,814,000 $20,086,000
                                              ========================

     LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
   Accounts payable                              $406,000    $845,000
   Accrued expenses and other current
    liabilities                                 1,003,000   1,703,000
   Customer deposit                                    --     327,000
   Deferred revenue                               726,000     147,000
                                              ------------------------
       Total current liabilities                2,135,000   3,022,000

Stockholders' equity:
   Preferred stock, $.01 par value; 1,250,000
    shares authorized, no shares issued and
    outstanding                                        --          --
   Common stock, $.01 par value; 30,000,000
    shares authorized, 9,991,943 shares issued    100,000     100,000
   Additional paid-in capital                  31,649,000  31,640,000
   Treasury stock (at cost, 57,663 shares)       (280,000)   (280,000)
   Accumulated deficit                        (14,790,000)(14,396,000)
                                              ------------------------
       Total stockholders' equity              16,679,000  17,064,000
                                              ------------------------
Total liabilities and stockholders' equity    $18,814,000 $20,086,000
                                              ========================

COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 30, 2003
Words:2006
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