CIMA LABS Announces Record Results for First Quarter of 2003; Revenues Nearly Double, Operating Income Rises More Than 150% Year-Over-Year.Business Editors/Health/Medical Writers EDEN PRAIRIE Eden Prairie A city of eastern Minnesota, a residential suburb of Minneapolis. Population: 57,300. , Minn.--(BUSINESS WIRE)--May 1, 2003 CIMA LABS INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (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. : CIMA) today reported record operating results for the first quarter of 2003 ended March 31. Revenues nearly doubled and operating income Operating Income The profit realized from a business' own operations. Notes: This would not include income from things such as investments in other firms. Also referred to as operating profit or recurring profit. was up more than 150% from the first quarter of 2002, driven by strong sales of Alavert(TM) and Remeron Remeron® Mirtazipine, see there (R) SolTabs(TM), fast-dissolve medications that CIMA manufactures for its partners Wyeth and Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. . -- Revenues totaled $16.7 million, an increase of 99% from the year-earlier period and nearly 8% sequentially from $15.5 million in the fourth quarter of 2002. -- Operating income was $3.9 million (23.2% of revenue), a 158% increase from the first quarter of 2002 and essentially flat with $4.0 million (25.9% of revenues) in the fourth quarter of 2002. -- Other income, principally investment income on cash reserves Cash reserves See: Cash investments cash reserves Investment funds that are held in short-term assets such as Treasury bills and certificates of deposit until more permanent investment opportunities are available. , declined $673,000, or approximately 39%, from the first quarter of 2002 due to lower reinvestment rates Reinvestment Rate The rate at which cash flows from fixed-income securities may be reinvested. Notes: Because of the additional interest income, bondholders can make larger investment returns if they reinvest received coupon payments. . -- Net income was $3.2 million, or $0.22 per share on a 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. basis, compared with first-quarter 2002 net income of $3.4 million, or $0.23 per diluted share. The decline in net income reflects CIMA recording income tax expense in the first quarter of 2003 compared to a small tax benefit recorded in the first quarter of 2002. A detailed discussion of CIMA's tax situation is included later in this release. "CIMA continued to perform well during the first quarter of 2003," stated Steven B. Ratoff, chairman and interim CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "In addition to generating record revenues on strong sales of Alavert and Remeron SolTabs, our business continued to evolve and mature. Operating income accounted for more than 78% of CIMA's first-quarter 2003 pre-tax income. This represents a significant improvement from the first quarter of 2002, when more than half of CIMA's pre-tax income was generated by our investment portfolio." "CIMA's shipments of Remeron SolTabs, our partner Organon's anti-depression medication, reached an all-time high in the first quarter of 2003, reflecting success in both the U.S. and international markets, where Organon continues to make progress with CIMA's fast-dissolve formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation . Remeron SolTab sales appeared not to have been affected by the introduction of a standard tablet See digitizer tablet and tablet computer. TABLET - A query language. ["Human Factor Comparison of a Procedural and a Non-procedural Query Language", C. Welty et al, ACM Trans Database Sys 6(4):626-649 (Dec 1981)]. generic form of mirtazapine mirtazapine /mir·taz·a·pine/ (mir?taz-ah-pen) an antidepressant structurally unrelated to any of the classes of antidepressants. in the U.S. In addition, Organon's ongoing European launch of Remeron SolTabs has been very successful. As a result, we now anticipate that overall customer demand for Remeron SolTabs will peak later in 2003 than we originally expected." "Sales of Alavert, our partner Wyeth's new over-the-counter fast-dissolve antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine. , grew rapidly in the first quarter," said Ratoff. "Alavert was launched by Wyeth late in the fourth quarter of 2002 with a strong national marketing and advertising campaign. Based on the market's response, we believe Alavert will be a significant contributor to CIMA's growth in 2003 and well into the future." During the quarter, CIMA continued to make progress with its product development pipeline. In March, Schwarz Pharma filed the second 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. submission related to its seven-product agreement with the Company, and CIMA expects additional submissions over the next two years. In addition, CIMA continued development of an as-yet-undisclosed branded prescription product for Schering-Plough as well as a fast-dissolve version of Allegra Al·leg·ra A trademark for the drug fexofenadine hydrochloride. fexofenadine hydrochloride Allegra, Telfast (UK) Pharmacologic class: Peripherally selective piperidine, selective histamine (R)for Aventis. The Company also moved forward on the prescription product it is developing for Alamo Alamo Eighteenth-century mission in San Antonio, Texas, site of a historic siege of a small group of Texans by a Mexican army (1836) during the Texas war for independence from Mexico. Pharmaceuticals. This product is expected to receive FDA approval later this year. In total, CIMA believes its partners will launch one or two new branded prescription products by the end of 2003. "Turning to our proprietary development activities, during the first quarter we made significant progress towards optimizing the OraVescent fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and formula, and we are currently preparing to conduct additional clinical trials later this year," said Ratoff. Stated chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. John Hontz, Ph.D., "Planning for the expansion of our manufacturing capacity has been a major focus for CIMA. The goal for these expansion efforts is to meet our partners' anticipated requirements for 2004. These plans include the installation of a bottling production line at our Brooklyn Park, Minnesota Brooklyn Park is a city in Hennepin County, Minnesota, United States. As of 2005, it had a population of 66,408. It is a northwestern suburb of Minneapolis, Minnesota. Geography According to the United States Census Bureau, the city has a total area of 68.8 km² (26. , facility by the end of 2003. In addition, we also are planning the addition of a third production line at our Eden Prairie, Minnesota The creator of this article, or someone who has substantially contributed to it, may have a conflict of interest regarding its subject matter. It may require cleanup to comply with Wikipedia's content policies, particularly neutral point of view. , facility by the end of the year. This expansion would double our annual capacity for blister-packaged tablets." Financial Review First-quarter 2003 sales of branded prescription and over-the-counter fast-dissolve products that CIMA manufactures for its partners increased 138% year-over-year and nearly 20% sequentially. "First-quarter sales benefited from the strength of Remeron SolTabs, both domestically and internationally, as well as solid performance from Zomig and the continued growth of Alavert," said James Hawley, CIMA's chief financial officer. CIMA receives product development fees and licensing revenues from its collaborative partners. In the first quarter of 2003, this revenue category decreased by 31% from the year-earlier period and by 44% sequentially. "Product development and licensing revenue reflects the timing of milestone payments and development work on certain projects, and can vary from quarter to quarter. This was the primary reason for the decline in product development fees and licensing revenues for the first quarter," said Hawley. CIMA's collaborative partners pay royalties based on their sales of the fast-dissolve products manufactured by the Company. Royalties on our partners' sales of the Company's fast-dissolve products increased by 172% in the first quarter of 2003 from first-quarter 2002 and by 19% from the sequential fourth quarter. The sequential growth in royalty payments is primarily attributable to an increase in royalty payments from Wyeth for Alavert. Other income, principally investment income on cash reserves, declined to $1.1 million in this year's first quarter from $1.7 million in the year-earlier period due primarily to lower reinvestment Reinvestment Using dividends, interest and capital gains earned in an investment or mutual fund to purchase additional shares or units, rather than receiving the distributions in cash. 1. In terms of stocks, it is the reinvestment of dividends to purchase additional shares. interest rates on cash reserves. CIMA has approximately $2 million of tax benefits remaining to be recognized, which it expects to record in future quarters in 2003. A normalized tax rate of approximately 40% is expected to apply to CIMA's earnings subsequent to recognizing the remaining $2 million of tax benefits. Excluding tax benefits of $200,000, earnings per diluted share at the fully taxed rate of 40% would be $0.20 for the first quarter of 2003 compared with $0.13 for the first quarter of 2002. CIMA's fully taxed earnings per share are a non-GAAP financial measure that the Company is using to provide a comparison to prior quarters. Cash and available-for-sale securities totaled $133 million at the end of the first quarter, compared with $131.7 million at the end of 2002. "CIMA's solid balance sheet and our expectation of continued strong cash flow from operating activities provide us with ample resources to fund our capital expansion projects and our investment in proprietary product development," said Hawley. Outlook "We believe that for the year 2003 our partners may sell as much as $500 million of products incorporating CIMA's technology," said Ratoff. "This would be more than double the $236 million sold in 2002. In addition, our anticipated growth in manufacturing and royalty revenues will continue to improve our ratio of operating income to other income, demonstrating the increasing maturity of our business as we continue to gain momentum with our pharmaceutical partners. Given this outlook, we continue to have confidence in our full-year revenue and earnings guidance." Second-Quarter and Full-Year 2003 Guidance For the second quarter of 2003, CIMA expects revenues to be in the range of $17.5 million to $19.0 million. Earnings per diluted share, based on an anticipated tax rate of 32% to 34%, are expected to be in the range of $0.22 to $0.25. For the full year 2003, the Company continues to expect revenue to be in the range of $70 million to $75 million. Earnings per share, based on a full-year tax rate of 31% to 33%, are expected to be in the range of $1.07 to $1.17 per diluted share. First Quarter Conference Call and Replay CIMA will review its first-quarter operating results in a conference call at 4:30 p.m. ET today. A replay of the conference call will be available for one week by dialing 719-457-0820 and providing the 248242 confirmation code. Investors also can listen to the conference call at www.cimalabs.com. Listeners should go to the Web site at least 15 minutes before the scheduled start time to download To receive a file transmitted over a network. In any communications session, "download" means receive, and "upload" means send. The download/upload often implies a big/little scenario, in which data is being downloaded from the "big" server into the "little" user's computer. and install any necessary audio software. About CIMA LABS CIMA develops and manufactures prescription and over-the-counter products based upon its proprietary, fast-dissolve drug delivery technologies, OraSolv(R) and DuraSolv(R). Based on its technologies, an active drug ingredient, which the Company frequently taste-masks, is formulated for·mu·late tr.v. for·mu·lat·ed, for·mu·lat·ing, for·mu·lates 1. a. To state as or reduce to a formula. b. To express in systematic terms or concepts. c. into a new, orally disintegrating dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. that dissolves quickly in the mouth without chewing chewing or mastication Up-and-down and side-to-side movements of the lower jaw, using the teeth to grind food for easier swallowing. During chewing, the tongue shapes food into a lump and saliva lubricates it for swallowing. or the need for water. CIMA's business involves a dual operating strategy. The Company develops and manufactures fast-dissolve versions of drugs for pharmaceutical company partners for whom CIMA currently produces three branded prescription pharmaceuticals and three over-the-counter brands. CIMA also is developing proprietary products utilizing its fast-dissolve technologies, as well as its new OraVescent(R) enhanced absorption, transmucosal drug delivery system. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement This press release contains 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 the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements include, but are not limited to those relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc CIMA's financial expectations for earnings and revenues for the second quarter and full year 2003, income tax benefits, new product introductions, marketing efforts of third parties, total sales of CIMA manufactured products, manufacturing capacity, and category leadership. A number of factors could cause actual results to differ materially from CIMA's assumptions and expectations. These factors include the successful completion of feasibility projects, consumer acceptance of CIMA's products, the receipt of firm orders for CIMA's products, the success of pharmaceutical companies in marketing CIMA's products, production costs, production yields, agreeing to commercial terms with pharmaceutical companies for new collaborative development and license agreements, capacity utilization Capacity Utilization measures the rate at which a firm makes use of their capital productive capacities, such as factories and machinery. Capacity Utilization generally rises when the economy is healthy and falls when demand softens. of product development and manufacturing resources, the outcome of tests in humans of proposed products, returns on investments, and recognition of income tax benefits. Additional factors that may cause actual results to differ from CIMA's assumptions and expectations include those set forth under the heading "Factors That Could Affect Future Results" included in CIMA's most recent filings with the Securities and Exchange Commission. All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements.
Condensed Statement of Operations
(in thousands, except per share)
Unaudited
Three Months Ended
March 31
2003 2002
Operating Revenues:
Net sales $10,068 $ 4,238
Product development fees and licensing 1,603 2,307
Royalties 5,002 1,838
Total operating revenues 16,673 8,383
Operating expenses:
Cost of goods sold 7,768 3,285
Research and product development 2,507 2,010
Selling, general and administrative 2,534 1,590
Total operating expenses 12,809 6,885
Operating income 3,864 1,498
Other income 1,066 1,739
Income before provision for taxes 4,930 3,237
Income tax expense (benefit) 1,772 (168)
Net income $ 3,158 $ 3,405
Net income per basic share $ 0.22 $ 0.24
Net income per diluted share $ 0.22 $ 0.23
Weighted average of number of shares:
Basic 14,282 14,159
Diluted 14,636 14,655
Pro forma: assumes income before tax is
subject to tax at a normalized rate of
40% (unaudited):
Net income as reported $ 3,158 $ 3,405
add back: Tax expense (benefit) as reported 1,772 (168)
less: tax expense at 40% (1,972) (1,295)
Pro forma net income $ 2,958 $ 1,942
Pro forma net income per diluted share $ 0.20 $ 0.13
Weighted average diluted shares 14,636 14,655
SELECTED BALANCE SHEET DATA
(in thousands)
March 31, December 31,
2003 2002
(unaudited) (audited)
Cash, cash equivalents and available-for-
sale securities - current & non-current $132,956 $131,681
Trade accounts receivable, net 13,427 14,621
Inventories, net 4,764 4,082
Property, plant & equipment, net 67,497 61,074
Deferred tax assets, net 9,910 11,414
Total assets 231,135 225,353
Current liabilities 14,193 12,052
Stockholders' equity 216,942 213,301
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