DUSA Pharmaceuticals Reports Fourth Quarter and Full Year 2005 Financial Results and Corporate Highlights.WILMINGTON Wilmington. 1 City (1990 pop. 71,529), seat of New Castle co., NE Del., on the Delaware River and tributary streams, the Christina and the Brandywine; settled 1638, inc. as a city 1832. , Mass. -- Record Kerastick(R) Sales Highlight Fourth Quarter Results DUSA DUSA Deputy Under Secretary of the Army DUSA Deakin University Student Association DUSA Dundee University Students' Association (Scotland) DUSA Designated Unclassified Subject Area Pharmaceuticals, 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 NMS See NetWare Management System. :DUSA) reported today fourth quarter and full year 2005 financial results and corporate highlights. During the fourth quarter and full year, the Company's revenues from product sales were $3,348,000 and $11,337,000 respectively, compared to $2,545,000 and $7,988,000 respectively in the comparable 2004 periods, reflecting record Kerastick(R) sales of the Company's Levulan(R) photodynamic therapy photodynamic therapy n. A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells. in dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. . Corporate Highlights: Levulan(R) Kerastick(R) 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. to end-users totaled 31,506 and 100,668 in the three and twelve month periods ended December 31, 2005, respectively. This represents an increase from 26,322 and 76,482 Kerastick(R) units sold in the three and twelve month periods ended December 31, 2004. The net number of BLU-U(R) units placed in doctors' offices during the fourth quarter of 2005 was 122. As of the end of 2005, there were 1,337 units in doctor's offices as compared with 914 units in doctor's offices at December 31, 2004. Bob Doman, DUSA's President and COO (Cell Of Origin) See mobile positioning. , stated "We are very pleased with the record Kerastick(R) sales results during the fourth quarter, which pushed total 2005 Kerastick(R) sales over 100,000 units, and total revenues over $11.3 million. We believe the positive fourth quarter results can be attributed to a number of factors, including continued market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" of Levulan(R) PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT with the addition of 256 new customers, positive impact of our actions taken to protect our intellectual property, the anticipated normalization In relational database management, a process that breaks down data into record groups for efficient processing. There are six stages. By the third stage (third normal form), data are identified only by the key field in their record. of inventory levels at physicians offices, a 5% price increase that became effective January 1, 2006, additional peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. articles and presentations at medical conferences related to our therapy, and the increased effectiveness of the expanded sales organization, many of whom were hired in the first half of this year. As we are also benefiting from decreased expenses, following our third quarter 2005 restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). , the positive combination of increased revenues and decreased expenses led to a significant reduction in our net loss for the quarter." "During the quarter, we also concluded the clinical portion of our Phase II trials using Levulan(R) PDT in the treatment of acne acne, common inflammatory disease of the hair follicles and sebaceous glands characterized by blackheads, whiteheads, pustules, nodules and, in the more severe forms, by cysts and scarring. The lesions appear on the face, neck, back, chest, and arms. and photo-damaged skin, respectively. Top-line acne results were issued last week. We continue to analyze the data and will incorporate the results into the next phase of our clinical development plan for Levulan(R) in acne. We expect that the results of the photodamage photodamage Photoaging Dermatology The structural and functional deterioration of sun-exposed skin, resulting in wrinkling, roughness, altered texture, discoloration, acral lentigines, mottled hyperpigmentation, ↓ epidermal thickness, basophilic degeneration trial should be ready for release in the next few weeks." "We are also very pleased to have recently completed our distribution agreement with Stiefel Laboratories on Levulan(R) PDT in dermatology for Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies. ; and we continue to work towards closing the Sirius Laboratories merger transaction during the first quarter of 2006," Mr. Doman concluded. Financial Highlights: For the three months ended December 31, 2005, DUSA's net loss was ($2,233,000), or ($0.13) per common share, compared to a loss of ($4,056,000), or ($0.24) per common share for the comparable 2004 period. For the twelve months ended December 31, 2005, DUSA's net loss was ($14,999,000), or ($0.89) per common share, compared to a loss of ($15,629,000), or ($0.96) per common share for the comparable 2004 period. Revenues for the three and twelve month periods ended December 31, 2005 were $3,348,000 and $11,337,000, compared to $2,545,000 and $7,988,000 in the comparable 2004 periods and were comprised of the following:
Three Months Ended Twelve Months Ended
December 31, December 31,
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2005 2004 2005 2004
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Kerastick(R) product sales
United States $2,568,000 $1,937,000 $7,957,000 $5,450,000
Canada 242,000 217,000 935,000 402,000
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Total $2,810,000 $2,154,000 $8,892,000 $5,852,000
BLU-U(R) product sales
United States $442,000 $314,000 $1,930,000 $1,795,000
Canada 96,000 77,000 515,000 341,000
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Total $538,000 $391,000 $2,445,000 $2,136,000
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Total product sales $3,348,000 $2,545,000 $11,337,000 $7,988,000
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The increase in 2005 Kerastick(R) revenues was driven mainly by increased volumes; as well as an increase in our average net selling price, which increased to $89.18 during the quarter ended December 31, 2005 from $81.80 for the comparable 2004 period. Fourth quarter of 2005 end-user Levulan(R) Kerastick(R) net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight to physicians totaled 31,506 Kerastick(R) units, including 28,038 sold in 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 3,468 sold in Canada, versus 26,322 in the fourth quarter of 2004, including 22,944 sold in the United States and 3,378 sold in Canada. The increase in 2005 BLU-U(R) revenues was also driven by an increase in our average selling price The average sales price of goods or commodities. Especially used in the retail sector and technology distribution. , which increased to $7,145 during the fourth quarter of 2005 from $6,872 for the comparable 2004 period. There were 74 units sold during the fourth quarter of 2005 versus 57 units in the comparable 2004 period. Total product gross margins for the three and twelve month periods ended December 31, 2005 were $1,916,000 or 57% and $5,124,000 or 45%, respectively, as compared to $1,283,000 or 50% and $4,113,000 or 51% for the comparable 2004 periods. Kerastick(R) margins increased on a pure dollar value basis to $1,868,000 in the fourth quarter of 2005 from $1,352,000 in the comparable 2004 period, and on a percentage basis to 66% from 63%. This increase in margin percentage is due to increased sales volumes and pricing. Our 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. goal is to achieve much higher gross margins on Kerastick(R) sales, which we believe will be significantly dependent on increased volume. BLU-U(R) gross margins were $49,000 or 9% for the fourth quarter of 2005 versus ($69,000) or (18%) in 2004. The increase in margins was due to increased pricing and lower overhead costs overhead costs see fixed costs. assigned as·sign tr.v. as·signed, as·sign·ing, as·signs 1. To set apart for a particular purpose; designate: assigned a day for the inspection. 2. to the product line as a result of the corporate restructuring which occurred earlier in the year. Our 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. strategy is to stay at or near break-even on device sales in an effort to drive Kerastick(R) sales volumes. However, our longer term goal is to move towards a reasonable profit margin on all device sales. Total operating costs operating costs npl → gastos mpl operacionales for the three and twelve month periods ended December 31, 2005 were $4,477,000 and $21,511,000, respectively as compared to $5,794,000 and $21,321,000 in the comparable 2004 periods. Research and development costs for the three and twelve month periods ended December 31, 2005 were $778,000 and $5,588,000 respectively, compared to $1,640,000 and $6,490,000 for the comparable 2004 periods, as we concluded the clinical portion of our Phase II clinical trials Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II for use of Levulan(R) PDT in photodamaged skin and moderate to severe acne vulgaris acne vul·gar·is n. An inflammatory eruption affecting the face, upper back, and chest, consisting of blackheads, cysts, papules, and pustules, and occurring primarily during puberty and adolescence. . Contributing to the decrease in spending for the three and twelve month periods ended December 31, 2005, compared with the comparable 2004 periods, is the Company's receipt of a refund TO REFUND. To pay back by the party who has received it, to the party who has paid it, money which ought not to have been paid. 2. On a deficiency of assets, executors and administrators cum testamento annexo, are entitled to have refunded to them legacies from the 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. for the 2003 and 2004 product and registration fees, which amounted to approximately $530,000. Marketing and sales costs for the quarter and year ended December 31, 2005 were $2,183,000 and $9,069,000 respectively, compared to $2,720,000 and $7,622,000 for the comparable 2004 periods. The increase in spending in the twelve month period ended December 31, 2005 compared with the comparable 2004 period is mainly attributed to increased personnel-related costs as a result of the expansion of our sales force. The decrease in spending for the three month period ended December 31, 2005, in comparison to the comparable 2004 period, is due primarily to decreased spending on marketing materials. General and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. for the quarter and year ended December 31, 2005 were $1,516,000 and $6,703,000 respectively, compared to $1,434,000 and $7,210,000 for the comparable 2004 periods. The decrease in spending for the full year to date in comparison to the prior year is mainly attributable to decreased legal costs due to the absence of patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. costs in Australia, partially offset by increased personnel-related costs. As of December 31, 2005, total cash, cash equivalents, and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has were $34,935,000, compared to $49,292,000 at the end of 2004. This decrease is primarily attributable to the funding of our operational expenses, most notably our marketing and sales and research and development efforts in support of our current and future products. Included in other current assets Other Current Assets A balance sheet item that includes the value of non-cash assets due within one year. Notes: Examples are things like prepaid expenses and accounts receivable. at December 31, 2005 in the accompanying Condensed con·dense v. con·densed, con·dens·ing, con·dens·es v.tr. 1. To reduce the volume or compass of. 2. To make more concise; abridge or shorten. 3. Physics a. Consolidated Balance Sheet consolidated balance sheet A balance sheet in which assets and liabilities of a parent company and its controlled subsidiaries are combined, thereby presenting balance sheet items for the parent and its subsidiaries as if they were a single firm. is approximately $830,000 of direct costs the Company incurred related to the previously announced definitive agreement to acquire all of the common stock of Sirius Laboratories Inc.
DUSA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31,
-------------------------------
2005 2004
(Unaudited)
-------------------------------
ASSETS
Current Assets
Cash and cash equivalents $4,210,675 $2,928,143
Marketable securities 30,579,486 46,222,969
Accounts receivable 373,130 711,016
Inventory 1,860,793 1,417,160
Other current assets 1,961,617 1,472,692
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Total current assets 38,985,701 52,751,980
Restricted cash 144,541 140,764
Restricted marketable securities - -
Property and equipment, net 2,971,869 3,481,888
Deferred charges and other assets 228,520 276,256
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TOTAL ASSETS $42,330,631 $56,650,888
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-------------------------------
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities
Accounts payable and accrued expenses $4,002,050 $3,722,716
Deferred revenue 94,283 230,715
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Total current liabilities 4,096,333 3,953,431
Other liabilities 205,570 190,439
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TOTAL LIABILITIES 4,301,903 4,143,870
TOTAL SHAREHOLDERS' EQUITY 38,028,728 52,507,018
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TOTAL LIABILITIES AND SHAREHOLDERS'
EQUITY $42,330,631 $56,650,888
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DUSA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended
December 31,
-------------------------------
2005 2004
(Unaudited) (Unaudited)
-------------------------------
REVENUES
Kerastick(R) Product Revenues, net $2,809,628 $2,153,222
BLU-U(R) Product Revenues, net 538,859 392,102
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PRODUCT REVENUES, NET 3,348,487 2,545,324
COST OF PRODUCT REVENUES
Kerastick(R) Cost of Product Revenues
and Royalties 941,940 800,722
BLU-U(R) Cost of Product Revenues 490,073 461,412
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COST OF PRODUCT REVENUES AND
ROYALTIES 1,432,013 1,262,134
GROSS MARGIN 1,916,474 1,283,190
OPERATING COSTS
Research and development 778,305 1,639,564
Marketing and sales 2,183,229 2,720,293
General and administrative 1,515,632 1,434,036
Restructuring - -
-------------------------------
TOTAL OPERATING COSTS 4,477,166 5,793,893
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LOSS FROM OPERATIONS (2,560,692) (4,510,703)
OTHER INCOME, NET 327,996 454,456
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NET LOSS $(2,232,696) $(4,056,247)
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BASIC AND DILUTED NET LOSS PER
COMMON SHARE $ (0.13) $ (0.24)
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-------------------------------
WEIGHTED AVERAGE NUMBER OF COMMON
SHARES OUTSTANDING 16,967,501 16,871,219
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-------------------------------
Twelve Months Ended
December 31,
-------------------------------
2005 2004
(Unaudited)
-------------------------------
REVENUES
Kerastick(R) Product Revenues, net $8,891,565 $5,850,835
BLU-U(R) Product Revenues, net 2,445,896 2,136,821
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PRODUCT REVENUES, NET 11,337,461 7,987,656
COST OF PRODUCT REVENUES
Kerastick(R) Cost of Product Revenues
and Royalties 3,583,650 2,023,685
BLU-U(R) Cost of Product Revenues 2,629,951 1,851,333
-------------------------------
COST OF PRODUCT REVENUES AND
ROYALTIES 6,213,601 3,875,018
GROSS MARGIN 5,123,860 4,112,638
OPERATING COSTS
Research and development 5,587,599 6,489,723
Marketing and sales 9,068,984 7,622,106
General and administrative 6,703,047 7,209,536
Restructuring 150,917 -
-------------------------------
TOTAL OPERATING COSTS 21,510,547 21,321,365
-------------------------------
LOSS FROM OPERATIONS (16,386,687) (17,208,727)
OTHER INCOME, NET 1,387,978 1,579,747
-------------------------------
NET LOSS $(14,998,709) $(15,628,980)
-------------------------------
-------------------------------
BASIC AND DILUTED NET LOSS PER
COMMON SHARE $ (0.89) $ (0.96)
-------------------------------
-------------------------------
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 16,932,138 16,317,078
-------------------------------
-------------------------------
DUSA Pharmaceuticals, Inc. is a biopharmaceutical company engaged primarily in the development and marketing of Levulan(R) Photodynamic Therapy (PDT) and Photodetection (PD) for multiple medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. , with a primary focus on dermatology. PDT and PD utilize light-activated compounds to induce in·duce v. 1. To bring about or stimulate the occurrence of something, such as labor. 2. To initiate or increase the production of an enzyme or other protein at the level of genetic transcription. 3. a therapeutic or detection effect. DUSA is a world leader in topically or locally applied PDT and PD. DUSA maintains offices in Wilmington, MA, Valhalla, NY and Toronto, Ontario. DUSA has also announced the signing of a definitive merger agreement with Sirius Laboratories of Vernon Hills Vernon Hill II (born circa 1946) is the founder and former chairman, president, and chief executive officer of Commerce Bancorp and Commerce Bank of Cherry Hill Township, New Jersey. , IL. Except for historical information, this news release contains certain 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. that represent our current expectations and beliefs concerning future events, and involve certain known and unknown risk and uncertainties. These forward-looking statements relate to beliefs regarding fourth quarter results, intention to incorporate recent acne results into development plans, timing of the results of the photodamage clinical trial, timing of the closing of the pending merger, and beliefs relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc gross margins being dependent on volume. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, changing market and regulatory conditions, the clinical trial process, the ability to obtain competitive levels of reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. by third-party payors, the maintenance of our patent portfolio, dependence on third-party manufacturers, the uncertainties of the litigation process, the ability to maintain our sales force, changes in our long and short term goals, fluctuations in the market price of the Company's common stock, unknown clinical trial results, the unknown sophistication so·phis·ti·cate v. so·phis·ti·cat·ed, so·phis·ti·cat·ing, so·phis·ti·cates v.tr. 1. To cause to become less natural, especially to make less naive and more worldly. 2. of the security holders of Sirius Laboratories, and other risks and uncertainties identified in DUSA's 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. DUSA Pharmaceuticals, Inc. (NASDAQ:DUSA) |
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