Anika Therapeutics Reports Second Quarter 2005 Financial Results.WOBURN, Mass. -- 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 NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ANIK ANIK Canadian COMSAT ) today reported financial results for the second quarter and six months ended June 30, 2005. Total revenue for the second quarter of fiscal 2005 increased 12.1% to $7,020,000 from $6,262,000 in the second quarter of 2004. The company posted net income of $1,337,000, or $.12 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, for the 2005 second quarter, compared with $765,000, or $.07 per diluted share, for the same period last year. Total revenue for the six-month period ended June 30, 2005 rose 15.4% to $14,311,000 from $12,403,000 for the comparable period last year. Net income was $2,539,000, or $.22 per diluted share, for the first six months of 2005, compared with $8,551,000, or $.75 per diluted share, for the first six months of 2004. The 2004 net income figures include a one-time tax benefit amounting to $7,039,000, or $.62 per diluted share, recorded in the first quarter of last year. During the quarter and six months ended June 30, 2005, the company recorded contract revenue of $2,249,000 and $3,167,000, respectively. Product revenue was $4,084,000 for the second quarter, versus $5,690,000 in the same period last year. For the six-month period, product revenue was $9,761,000 versus $11,259,000 in the comparable period in 2004. Product revenue in the second fiscal quarter of 2005 was adversely affected by defective defective adj. not being capable of fulfilling its function, ranging from a deed of land to a piece of equipment. (See: defect, defective title) vendor-supplied finished goods packaged with the 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" product, resulting in a recall of 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. product which reduced sales in the quarter by $1,359,000. While the company expects to recapture recapture n. in income tax, the requirement that the taxpayer pay the amount of tax savings from past years due to accelerated depreciation or deferred capital gains upon sale of property. (See: income tax) RECAPTURE, war. most of these sales of ophthalmic product over the balance of the year, it is still assessing the overall financial impact on results for 2005. Sales of the company's 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) product were $2,192,000 in the second quarter versus $2,796,000 in the same period last year. The company expects the previously announced involvement of the DePuy Mitek division of Johnson & Johnson to begin impacting OrthoVisc sales in the third quarter of this year. For the six-month period, OrthoVisc sales were $4,593,000 versus $5,071,000 in the comparable period of 2004. Ophthalmic product sales for the second quarter were $1,570,000 versus $2,688,000 in the second quarter of 2004, which reflects the impact of the recall discussed above, and were $4,339,000 for the six-month period compared with $5,062,000 last year. Second quarter sales of Hyvisc(R), the company's veterinary product, increased to $322,000 from $206,000 in the year ago period. For the six-month period, Hyvisc sales totaled $829,000 versus $1,126,000 last year. Product gross margin for the quarter was 48.2% versus 57.1% in the 2004 second quarter, reflecting the impact of the recall and product mix. For the six-month period ended June 30, product gross margin was 47.6% versus 54.1% in the comparable period last year. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. were $2,936,000 for the second quarter of 2005, compared with $2,532,000 in the second quarter of 2004. The increase reflects continued research and development activity associated with two clinical trials and an increase in selling, general and administrative expenses related to increases in professional service fees. For the six-month period, total operating expenses increased to $5,427,000 from $4,747,000 in 2004. Anika's cash and cash equivalents at June 30, 2005 totaled $39,930,000. The company has no long-term debt Long-Term Debt Loans and financial obligations lasting over one year. Notes: For example debts obligations such as bonds and notes which have maturities greater than one year would be considered long-term debt. . Conference Call Information The company will hold a conference call to review its financial results, business highlights and outlook on Thursday, July 28, 2005, at 9:00 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 . In addition, the company may address during the conference call its business and financial developments and trends, including those involving product lines and business partners; and other business and financial matters affecting the company, which may contain information that has not been previously disclosed. 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 broadcast at www.anikatherapeutics.com. The call will be archived and accessible on the same Web site for one year shortly after the completion of the call. 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. Anika products include OrthoVisc(R), a treatment for 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. of the knee available internationally and marketed in the U.S. by DePuy Mitek and Ortho Biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. Products, L.P., and Hyvisc(R), a 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 marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc. Anika manufactures Amvisc(TM) and Amvisc Plus(TM), HA viscoelastic products for ophthalmic surgery. It also produces STAARVISC(TM)-II, which is distributed 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 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 and margin growth; (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 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. and European markets, for osteoarthritis of the knee; (vii) the Company's objectives towards increasing market share for ORTHOVISC(R) in international and domestic markets or otherwise penetrate growing markets for osteoarthritis of the knee; (viii) the Company's corporate objectives and research and development and collaboration opportunities, including, without limitation, intended preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. development of potential cosmetic cosmetic /cos·met·ic/ (koz-met´ik) 1. pertaining to cosmesis. 2. a beautifying substance or preparation. cos·met·ic n. tissue augmentation AUGMENTATION, old English law. The name of a court erected by Henry VIII., which was invested with the power of determining suits and controversies relating to monasteries and abbey lands. products and commencement of INCERT(R) clinical trials; (ix) the Company's plans for augmenting its infrastructure; and (x) the Company's expectations regarding ophthalmic product sales during the remainder of 2005 and the impact of the ophthalmic product recall on future 2005 financial results. 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 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. approval, and/or receive FDA or other regulatory approvals of its products, 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 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 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, German, Canadian, Middle Eastern and French economies, 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; (iii) new distribution arrangements, including the agreement with Ortho Biotech Products, L.P. (and DePuy Mitek) pertaining per·tain intr.v. per·tained, per·tain·ing, per·tains 1. To have reference; relate: evidence that pertains to the accident. 2. to ORTHOVISC(R), will not result in meaningful sales of the Company's products; (iv) the Company will be unable to achieve performance and sales threshold milestones in its distribution agreements; (v) competitive products will adversely impact the Company's product sales; (vi) the estimated size(s) of the markets which the Company has targeted its products will fail to be achieved; or (vii) increased sales of the Company's products, including HYVISC(R), ORTHOVISC(R), or its ophthalmic products, will not continue or sales will decrease or not reach historical sales levels, or even if such increases occur that such increases will improve gross margins, 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, 2004, and its Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2005 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)
Quarter Ended Six Months Ended
June 30, June 30,
2005 2004 2005 2004
----------- ----------- ----------- ------------
Product revenue $4,084,000 $5,690,000 $9,761,000 $11,259,000
Licensing, milestone
and contract revenue 2,936,000 572,000 4,550,000 1,144,000
----------- ----------- ----------- ------------
Total revenue 7,020,000 6,262,000 14,311,000 12,403,000
Cost of product
revenue 2,117,000 2,442,000 5,111,000 5,163,000
----------- ----------- ----------- ------------
Gross profit 4,903,000 3,820,000 9,200,000 7,240,000
Operating expenses:
Research and
development 1,461,000 1,125,000 2,660,000 2,032,000
Selling, general and
administrative 1,475,000 1,407,000 2,767,000 2,715,000
----------- ----------- ----------- ------------
Total operating
expenses 2,936,000 2,532,000 5,427,000 4,747,000
----------- ----------- ----------- ------------
Income from operations 1,967,000 1,288,000 3,773,000 2,493,000
Interest income 275,000 80,000 487,000 126,000
----------- ----------- ----------- ------------
Income before income
taxes 2,242,000 1,368,000 4,260,000 2,619,000
Income tax expense
(benefit)
Provision for income
taxes 905,000 603,000 1,721,000 1,107,000
Benefit from release
of valuation
allowance - - - (7,039,000)
----------- ----------- ----------- ------------
Net income $1,337,000 $765,000 $2,539,000 $8,551,000
=========== =========== =========== ============
Basic net income per
common share $0.13 $0.08 $0.25 $0.85
=========== =========== =========== ============
Basic shares
outstanding 10,391,538 10,060,866 10,330,883 10,024,138
=========== =========== =========== ============
Diluted net income per
common share $0.12 $0.07 $0.22 $0.75
=========== =========== =========== ============
Diluted shares
outstanding 11,458,827 11,396,116 11,302,663 11,333,899
=========== =========== =========== ============
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
June 30, December 31,
2005 2004
------------ ------------
ASSETS
Current assets:
Cash and cash equivalents $39,930,000 $39,339,000
Accounts receivable, net 2,744,000 2,354,000
Inventories 4,037,000 4,227,000
Current portion deferred income taxes 1,824,000 1,824,000
Prepaid expenses and other current
assets 616,000 1,339,000
------------ ------------
Total current assets 49,151,000 49,083,000
Property and equipment 10,675,000 10,349,000
Less accumulated depreciation (9,616,000) (9,394,000)
------------ ------------
Net property and equipment 1,059,000 955,000
Long-term deposits 143,000 143,000
Deferred income taxes 9,357,000 9,357,000
------------ ------------
Total assets $59,710,000 $59,538,000
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $381,000 $791,000
Other accrued expenses 1,458,000 2,041,000
Deferred revenue 3,112,000 4,116,000
------------ ------------
Total current liabilities 4,951,000 6,948,000
Long-term deferred revenue 20,250,000 22,227,000
Stockholders' equity:
Common stock 105,000 103,000
Additional paid-in capital 34,243,000 32,639,000
Retained earnings (deficit) 161,000 (2,379,000)
------------ ------------
Total stockholders' equity 34,509,000 30,363,000
------------ ------------
Total liabilities and stockholders' equity $59,710,000 $59,538,000
============ ============
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