CIMA LABS Reports Record Third Quarter Operating Results; Full-Year 2002 Financial Guidance Increased Due to Outlook for Strong Fourth Quarter.Business Editors EDEN PRAIRIE Eden Prairie A city of eastern Minnesota, a residential suburb of Minneapolis. Population: 57,300. , Minn.--(BUSINESS WIRE)--Oct. 31, 2002 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:CIMA) today reported record operating results for the third quarter of 2002 ended September September: see month. 30: -- Operating revenues totaled $12.5 million, an increase of 42% from $8.8 million in the year-earlier period and up 23% from $10.2 million in this year's second quarter. -- Operating income totaled $2.3 million, an increase of 107% from $1.1 million in the third quarter of 2001 and up 18% from $2.0 million in this year's second quarter. -- Net income increased 14% to $4.4 million or $0.30 per diluted share, from $3.8 million or $0.24 per diluted share a year ago. Third quarter net income was also up 5% from $4.2 million or $0.28 per diluted share in this year's second quarter. John M. Siebert, Ph.D., president and chief executive officer, commented: "CIMA's excellent third quarter performance was driven by strong operating contributions from each component of our business. CIMA shipped a record number of fast-dissolve tablets; royalty income reflects the accelerating growth in our partners' sales of fast-dissolve products; and record levels of product development fees and licensing revenues are indicative of the magnitude and value of our product development pipeline. During the third quarter, we announced a major collaborative col·lab·o·rate intr.v. col·lab·o·rat·ed, col·lab·o·rat·ing, col·lab·o·rates 1. To work together, especially in a joint intellectual effort. 2. agreement with Aventis Aventis Is a pharmaceutical and lab assay testing company. It was formed in 1999 when Rhône-Poulenc S.A. merged with Hoechst AG. The merged company was based in Strasbourg, France. Sanofi-Aventis was formed in 2004 when Sanofi-Synthélabo purchased Aventis. Pharmaceuticals, Inc. to develop 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 (fexofenadine fexofenadine /fex·o·fen·a·dine/ (fek?so-fen´ah-den) an antihistamine (H1-receptor antagonist) used as the hydrochloride salt in the treatment of hay fever and chronic idiopathic urticaria. ), one of the leading non-sedating antihistamines Antihistamines Definition Antihistamines are drugs that block the action of histamine (a compound released in allergic inflammatory reactions) at the H1 on the market today. Our relationship with Aventis follows announcements earlier this year of new collaborations with Schering-Plough Schering-Plough Corporation (NYSE: SGP) is a pharmaceutical company which traces its history back to 1851 when Ernst Schering founded Schering AG in Germany. Following the entry of the United States into World War II in 1941, U.S. and Wyeth. We believe our increasingly successful strategy of developing important new fast-dissolve products in collaboration Working together on a project. See collaborative software. with major pharmaceutical companies sets the stage for progressively stronger operating results over the next few years." John Hontz, Ph.D., 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. , said, "During the third quarter, development was completed on several projects in our product development pipeline. Over the next three to nine months, we expect to add several new partner-funded feasibility fea·si·ble adj. 1. Capable of being accomplished or brought about; possible: a feasible plan. See Synonyms at possible. 2. projects to our product development pipeline. During the fourth quarter, we will ship to Wyeth pre-launch supplies of DuraSolv(R) loratadine loratadine /lor·at·a·dine/ (lah-rat´ah-den) a nonsedating antihistamine used in the treatment of allergic rhinitis, chronic idiopathic urticaria, and asthma. lor·at·a·dine n. , a pharmaceutical equivalent to Claritin Clar·i·tin A trademark for the drug loratadine. loratadine Alavert, Claritin, Claritin RediTabs, Clarityn (UK) Pharmacologic class: Histamine1-receptor antagonist (second-generation) (R) RediTabs(R). One to two additional product introductions are possible during 2003, followed by another three to five in 2004. In addition, clinical trials on OraVescent(R) 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 , one of our proprietary products, commenced in the third quarter. " Financial Review Sales of fast-dissolve products that CIMA manufactures for its partners rose 13% in this year's third quarter from the year-earlier period and by 31% from this year's second quarter. Sales of CIMA's branded prescription products accounted for 76% of total third quarter product sales, up from 36% in last year's third quarter. As expected, third quarter sales of OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). products increased from this year's second quarter and are expected to grow further in the fourth quarter. It is anticipated that total product sales should reach a new record level in this year's fourth quarter. CIMA receives product development fees and licensing revenues from its collaborative partners. Reflecting the year-over-year growth in CIMA's product development pipeline, this revenue category rose 64% in this year's third quarter in comparison to the year-earlier period. This revenue category, which was also up 6% from this year's second quarter, varies between quarters primarily due to the timing of scheduled milestone “Milemarker” redirects here. For the American indie rock band, see Milemarker (band). A milestone or kilometre sign is one of a series of numbered markers placed along a road at regular intervals, typically at the side of the road or in a median. payments. CIMA's partners pay royalties based on their sales of the fast-dissolve products manufactured by the Company. Reflecting the continued growth of our partners' sales, royalty revenues rose 118% in this year's third quarter in comparison to the year-earlier period and by 28% from this year's second quarter. Royalties accounted for 26% of third quarter operating revenues operating revenue Revenue from any regular source. Revenue from sales is adjusted for discounts and returns when calculating operating revenue. Compare other revenue. , compared to 25% in this year's second quarter and 17% in the third quarter of 2001. Further growth in royalty revenues is anticipated as the branded prescription products introduced primarily in 2001 become increasingly established in their therapeutic categories and geographic markets. It is anticipated that this growth will be augmented in 2003 by Wyeth's sales of DuraSolv loratadine, as well as additional market launches later in that year. R&D expense increased 119% to $3.4 million, or 27% of total operating revenues, in the third quarter of 2002, from $1.5 million, or 18% of total operating revenues, in the year-earlier quarter. R&D expense was also up 36% from $2.5 million, or 24% of total operating revenues, in this year's second quarter. For full-year 2002, R&D expense related to CIMA's proprietary products is expected to amount to approximately $1.0 million, of which approximately $700,000 was incurred during the first nine months of this year. Selling, general and administrative expense increased 51% to $1.8 million, or 15% of total operating revenues, in this year's third quarter, from $1.2 million, or 14% of total operating revenues, in the third quarter of 2001. SG&A expense was down 5% from $1.9 million, or 19% of total operating revenues, in this year's second quarter. 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. increased 107% to $2.3 million in this year's third quarter from $1.1 million in the third quarter of 2001. For the first nine months of 2002, operating income increased 84% to $5.8 million from $3.1 million in the comparable nine-month period of 2001. Since turning profitable in the fourth quarter of 1999, CIMA has not incurred income tax expense due to the recognition of approximately $13.1 million of U.S. tax credits carried over from the years when the Company was not profitable. Without these credits, CIMA's cumulative tax expense for this period of time would have been approximately $11.9 million, based on a tax rate of 40%. For the first nine months of 2002, the Company has reported a $1.1 million bottom-line bot·tom-line adj. 1. Concerned exclusively with costs and profits: bottom-line issues. 2. Ruthlessly realistic; pragmatic: a bottom-line political strategy. tax benefit. CIMA expects to recognize its remaining tax benefits in the fourth quarter of 2002. Cash and available-for-sale securities totaled $140.7 million at the end of this year's third quarter, down from $149.5 million at the end of 2001. For the third quarter and first nine months of 2002, cash of $9.4 million and $26.9 million, respectively, was used to fund capital expenditures supporting expansion of R&D and manufacturing capacity. These growth-related capital expenditures are expected to total approximately $37.0 million to $39.0 million in 2002, up from prior estimates of approximately $35.0 million. Due to these uses of cash, as well as lower interest rates 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. , other income, principally investment income on cash reserves, declined to $1.4 million in this year's third quarter from $2.7 million in the year-earlier period and from $1.9 million in this year's second quarter. Fourth Quarter/Full-Year 2002 Guidance For the fourth quarter of 2002 ending December December: see month. 31, CIMA expects earnings of $0.41 to $0.44 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 on operating revenues of $14.0 to $15.0 million. Reflecting the strength of CIMA's operations, operating income is expected to be in the range of $3.2 to $3.7 million. As a result, CIMA is raising its full-year earnings forecast to $1.23 to $1.26 per diluted share on operating revenues of $45.0 to $46.0 million, operating income in the range of $9.0 to $9.5 million and an estimated bottom-line tax benefit of $2.0 to $2.5 million. The timing of milestone payments from partner-funded product development collaborations, the rate of spending on infrastructure initiatives and taxes will affect where operating revenues and earnings fall within these targeted ranges. Consistent with its prior practice, the Company will present financial guidance for 2003 in its press release announcing fourth quarter operating results in February February: see month. . 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 our technologies, an active drug ingredient
An ingredient is something that forms part of a mixture (in a general sense). , which we frequently taste-mask, 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. We develop and manufacture fast-dissolve versions of drugs for pharmaceutical company partners for whom we currently produce three branded prescription pharmaceuticals and two over-the-counter brands. CIMA is also developing proprietary products utilizing our fast-dissolve technologies, as well as our new OraVescent(R) enhanced absorption, transmucosal transmucosal /trans·mu·co·sal/ (trans?mu-ko´s'l) entering through, or across, a mucous membrane. transmucosal, drug delivery system. Cautionary Statement This press release, including the information related to CIMA's expectations about earnings and revenues, new product development agreements, new product introductions, marketing efforts of third parties, sources of future revenues, other income, 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. 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, and returns on investments. 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.
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Third Quarter Conference Call and Replay
CIMA Labs will review its third quarter operating results in a
conference call at 4:30 PM Eastern today. Investors can listen to the
conference call at www.cimalabs.com or www.vcall.com. Listeners should
go to one of these web sites at least 15 minutes before the scheduled
start time to download and install any necessary audio software. For
those who cannot listen to the live webcast, a replay will be
available shortly after the teleconference at the Vcall web site. A
replay of the conference call also will be available through November
7 at 719-457-0820 and providing the 511345 confirmation code.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share)
(Unaudited) (Unaudited)
For the 3 Months Ended For the 9 Months Ended
---------------------- ----------------------
September September September September
30, 30, 30, 30,
2002 2001 2002 2001
----------- ---------- ------------ ---------
Operating Revenues:
Net sales $6,094 $5,376 $14,970 $13,273
Product development
fees and licensing 3,242 1,972 8,610 5,883
Royalties 3,205 1,469 7,544 3,676
----------- ---------- ------------ ---------
Total operating revenues 12,541 8,817 31,124 22,832
Operating expenses:
Cost of goods sold 4,997 4,930 12,165 11,648
Research and product
development 3,388 1,549 7,927 4,399
Selling, general and
administrative 1,839 1,220 5,259 3,648
----------- ---------- ------------ ---------
Total operating expenses 10,224 7,699 25,351 19,695
Operating income 2,317 1,118 5,773 3,137
Other income 1,449 2,685 5,126 7,572
----------- ---------- ------------ ---------
Income before provision
for taxes 3,766 3,803 10,899 10,709
Income tax expense
(benefit) (617) (38) (1,056) 196
----------- ---------- ------------ ---------
Net income $4,383 $3,841 $11,955 $10,513
=========== ========== ============ =========
Net income per basic
share $.31 $.26 $.84 $.72
=========== ========== ============ =========
Net income per diluted
share $.30 $.24 $.82 $.68
=========== ========== ============ =========
Weighted average of
number of shares:
Basic 14,209 14,715 14,172 14,564
Diluted 14,598 15,699 14,598 15,557
SELECTED BALANCE SHEET DATA
(in thousands)
September 30, December 31,
2002 2001
(Unaudited) (Audited)
-------------- --------------
Cash, cash equivalents and available-for-
sale securities - Current and
Noncurrent $ 140,688 $ 149,505
Trade accounts receivable, net 10,243 8,963
Inventories, net 3,340 3,771
Property, plant and equipment, net 52,466 27,761
Deferred tax assets, net 9,475 6,200
Total Assets 218,395 198,931
Current liabilities 11,919 4,154
Stockholders' Equity 206,476 194,777
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