Anika Therapeutics Reports 74% Revenue Increase to $6.4 Million for 2004 Third Quarter.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 that revenue for the third quarter ended September 30, 2004, increased 74% to $6,407,000 from $3,688,000 in the third quarter of 2003. The company posted net income of $884,000, or $0.08 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 2004 third quarter, compared with net income of $420,000, or $0.04 per diluted share, for the 2003 third quarter. For the nine-month period ended September 30, 2004, revenue rose 81% to $18,810,000 from $10,390,000 for the comparable period last year. Net income was $9,435,000, or $0.83 per diluted share, for the first nine months of 2004, compared with $26,000, essentially a break-even on a per share basis, for the first nine months of 2003. Year-to-date results for 2004 include a one-time tax benefit amounting to $7,039,000, equal to $0.62 per fully diluted share, recorded in the first quarter. Third quarter 2004 product revenue was $5,554,000, an increase of 52% from $3,666,000 for the same period last year. For the nine months ended September 30, 2004, product revenue was $16,813,000, an increase of 63% from $10,339,000 for the comparable period last year. Total revenue for the quarter and nine months ended September 30, 2004, reflects licensing, milestone and contract revenue of $853,000 and $1,997,000, respectively, which includes $550,000 and $1,650,000 attributable to the amortization of previously announced milestone payments received in connection with the licensing and supply agreement with Ortho Biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. , the company's U.S. marketing and distribution partner for OrthoVisc. OrthoVisc sales accounted for 38% of the total product sales for the third quarter, primarily reflecting continued strength in international markets and growing market share in the U.S. "Internationally, Turkey and Canada continue to be high performing regions for OrthoVisc," said Charles Sherwood This article is about the pocket knife manufacturer. For other uses, see Charles D. Sherwood. Charles Sherwood of Camillus, New York was a leading manufacturer of pocket knives in the United States during the late 1890s. , Ph.D., president and chief executive officer of Anika Therapeutics. "In the U.S. market, our traction to date has been slower than we would like, but we remain enthusiastic and are working closely with our distribution partner to further stimulate adoption and awareness for OrthoVisc. "We are making excellent strides towards advancing two additional products through the regulatory process toward commercialization," continued Sherwood. "We have completed enrollment in our 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 study for Anika's cosmetic 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. product (CTA An abbreviation for cum testamento annexo, Latin for "with the will annexed." ) for correcting nasolabial folds. Our commercial partner Ortho Neutrogena is funding this study and is working closely with us on developing possible line extensions of hyaluronic acid-based dermatological dermatological, dermatologic pertaining to dermatology; of or affecting the skin. products. Finally, our human pilot study of HA-based INCERT(R) for the prevention of internal adhesions Adhesions Definition Adhesions are fibrous bands of scar tissue that form between internal organs and tissues, joining them together abnormally. or scarring scar 1 n. 1. A mark left on the skin after a surface injury or wound has healed. 2. A lingering sign of damage or injury, either mental or physical: following spinal surgery is moving along nicely with 50% enrollment at two centers in the United Kingdom." Sales of the company's 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. products accounted for 56% of total product sales in the 2004 third quarter. These sales represented a 27% increase over ophthalmic product sales in the third quarter of last year. Sales of Hyvisc(R), the company's product 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. , were down 16% for the quarter as compared to the prior-year comparable quarter, but up 47% from the second quarter. Hyvisc accounted for approximately 6% of product sales for the period. Gross margin on product revenue for the third quarter of 2004 was 55.9% compared with 47.4% for the same period last year, underscoring a continuing shift in revenue mix, increased unit volumes and manufacturing efficiency gains. 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. rose 79% to $2,445,000 for the third quarter of 2004 as compared to $1,367,000 in the third quarter of 2003. Contributing to this were higher research and development expenses of $988,000 versus $482,000 in the same period last year, attributable to the ongoing clinical trials for INCERT(R) and CTA. In addition, selling, general and administrative expenses related to increases in personnel costs and professional service fees also rose during the quarter. A provision for taxes of $734,000 related to third quarter income was recorded. This represents a 45.3% tax rate. Anika's cash and cash equivalents at September 30, 2004, totaled $34.0 million. This compares with $33.5 million at June 30, 2004, and $14.6 million at December 31, 2003. The company continues to have 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 on Friday, October 29, 2004, 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 broadcast at http://www.anikatherapeutics.com. The call will be archived and accessible on the same Web site for one year beginning at approximately 2:00 p.m. EDT, Friday, October 29, 2004. About Anika Therapeutics, Inc. Headquartered in Woburn, 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. Anika products include OrthoVisc(R), a treatment for osteoarthritis of the knee, available internationally and marketed in the U.S. by Ortho Biotech Products, L.P., and Hyvisc(R), a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc. Anika manufactures Amvisc(TM) and Amvisc Plus(TM), 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 CoEase(TM), which is marketed by Advanced Medical Optics Advanced Medical Optics, Inc., (NYSE: EYE) (known as AMO) is a global medical device leader focused on the discovery and delivery of innovative vision technologies that optimize the quality of life for people of all ages. , Inc.; STAARVISC(TM)-II, 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. 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, (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, including Germany and France, 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 tissue augmentation products and commencement of INCERT(R) clinical trials, and (ix) the results of the U.S. launch for ORTHOVISC(R). 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 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. 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 to 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 Reports 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, 2003, and its Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended June 30, 2004, 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 Nine Months Ended
September 30, September 30,
2004 2003 2004 2003
Product revenue $5,554,000 $3,666,000 $16,813,000 $10,339,000
Licensing,
milestone and
contract revenue 853,000 22,000 1,997,000 51,000
----------- ----------- ------------ ------------
Total revenue 6,407,000 3,688,000 18,810,000 10,390,000
Cost of product
revenue 2,451,000 1,930,000 7,614,000 5,745,000
----------- ----------- ------------ ------------
Gross profit 3,956,000 1,758,000 11,196,000 4,645,000
Operating expenses:
Research and
development 988,000 482,000 3,020,000 1,939,000
Selling, general
and
administrative 1,457,000 885,000 4,172,000 2,945,000
----------- ----------- ------------ ------------
Total operating
expenses 2,445,000 1,367,000 7,192,000 4,884,000
----------- ----------- ------------ ------------
Income (loss) from
operations 1,511,000 391,000 4,004,000 (239,000)
Interest income 107,000 29,000 233,000 111,000
----------- ----------- ------------ ------------
Income (loss)
before income tax
expense (benefit) 1,618,000 420,000 4,237,000 (128,000)
Income tax expense
(benefit):
Provision
(benefit) for
income taxes 734,000 - 1,841,000 (154,000)
Benefit from
release of
valuation
allowance - - (7,039,000) -
----------- ----------- ------------ ------------
Net income (loss) $884,000 $420,000 $9,435,000 $26,000
=========== =========== ============ ============
Basic net income
(loss) per share $0.09 $0.04 $0.94 $0.00
Basic shares
outstanding 10,140,925 9,959,904 10,063,351 9,945,195
Diluted net income
(loss) per share $0.08 $0.04 $0.83 $0.00
Diluted shares
outstanding 11,506,999 10,422,066 11,406,098 10,271,681
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
(unaudited)
September 30, December 31,
2004 2003
ASSETS
Current assets:
Cash and cash equivalents $34,003,000 $14,592,000
Restricted cash - 818,000
Accounts receivable, net 3,075,000 1,421,000
Inventories 4,166,000 3,627,000
Current portion deferred income
taxes 1,363,000 -
Prepaid expenses and other
current assets 1,405,000 81,000
------------------ ----------------
Total current assets 44,012,000 20,539,000
Property and equipment 10,295,000 9,875,000
Less accumulated depreciation (9,202,000) (8,684,000)
------------------ ----------------
Net property and equipment 1,093,000 1,191,000
Long-term deposits 143,000 143,000
Deferred income taxes 8,818,000 -
------------------ ----------------
Total assets $54,066,000 $21,873,000
================== ================
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable $836,000 $349,000
Other accrued expenses 1,587,000 1,297,000
Deferred revenue 3,571,000 378,000
Income taxes payable - 65,000
------------------ ----------------
Total current liabilities 5,994,000 2,089,000
Long-term deferred revenue 20,186,000 1,800,000
Stockholders' equity:
Common stock 102,000 100,000
Additional paid-in capital 31,918,000 31,480,000
Treasury stock - (27,000)
Accumulated deficit (4,134,000) (13,569,000)
------------------ ----------------
Total stockholders' equity 27,886,000 17,984,000
------------------ ----------------
Total liabilities and
stockholders' equity $54,066,000 $21,873,000
================== ================
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