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CIMA LABS Updates Third-Quarter and Full-Year 2003 Guidance.


Business Editors/Health/Medical Writers

EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Oct. 9, 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
: CIMA) announced today that it is updating its guidance for the third quarter and full year 2003. Third-quarter revenues are expected to be within the Company's previously announced guidance range of $19.0 million to $20.5 million, but earnings per diluted share will be affected by expenses related to CIMA's proposed merger with aaiPharma, Inc. (NASDAQ: AAII AAII

See: American Association of Individual Investors
). CIMA also is narrowing its full-year revenue guidance to a range of $72 million to $75 million from its earlier range of $70 million to $75 million.

For the third quarter, the Company expects to incur merger-related advisory, investment banking, legal and administrative expenses in connection with the proposed merger with aaiPharma, Inc. in the range of $3.5 million to $4.0 million. Under Generally Accepted Accounting Principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records.

Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting
 (GAAP GAAP

See: Generally Accepted Accounting Principles


GAAP

See generally accepted accounting principles (GAAP).
), CIMA is required, as the accounting acquiree in the transaction, to expense costs related to the merger as they are incurred. Additionally, for U.S. federal tax purposes, these costs are not tax deductible.

CIMA previously expected third-quarter 2003 GAAP EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format.  to be in the range of $0.24 to $0.27. Solely as a result of the anticipated merger-related expenses, CIMA now expects to report GAAP diluted third-quarter earnings per share in the range of $0.03 to $0.06. In the fourth quarter, CIMA expects to incur additional merger-related expenses that the Company is unable to quantify at the present time and, as a result, is withdrawing its full-year 2003 earnings guidance.

"We continue to expect another solid year of revenue growth for CIMA in 2003," said CIMA Chairman of the Board 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.  Steven B. Ratoff. "Product sales to our partners are meeting or exceeding our expectations and royalty revenues are trending upward. As a result, we are narrowing our full-year revenue range toward the high end. We now expect 2003 revenues to be in the range of $72 million to $75 million, compared with our previous expectation of $70 million to $75 million. However, the mix of our revenues will be different than we previously anticipated.

"We remain in active discussions regarding new projects with current and potential partners, and we are excited about the opportunities that exist in our pipeline. In addition, reflecting the preferences of existing and potential CIMA partners as well as current trends in the pharmaceutical industry, we have, in certain instances, modified our approach to business development. In these instances, we anticipate that development activities will generate less revenue in the early stages and more revenue from long-term milestones. We also have renegotiated the nature and timing of payments for certain in-process R&D activities," said Ratoff.

CIMA expects to report its third-quarter 2003 financial results on October 30, 2003.

CIMA Reschedules 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.
 Meeting for 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  Clinical Trials

CIMA also announced today that it will hold its meeting with the Food & Drug Administration (FDA) to discuss Phase III clinical trial Noun 1. phase III clinical trial - 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  protocols for the Company's OraVescent Fentanyl breakthrough cancer pain medication prior to the end of the year. CIMA had originally expected to meet with the FDA in October, but scheduling conflicts have necessitated a temporary postponement.

"We are prepared and look forward to meeting with the FDA. In addition, we believe that we are on target to achieve our previously announced plans to file a regulatory submission for OraVescent Fentanyl late in 2004 or early 2005, with a product launch occurring in late 2005 or early 2006," said Ratoff.

OraVescent Fentanyl combines Fentanyl citrate fentanyl citrate
n.
A narcotic analgesic used as a supplementary analgesic agent in general anesthesia.


fentanyl citrate Warning - High-alert drug!

Sublimaze
, a pharmaceutical compound indicated for breakthrough cancer pain, with CIMA's proprietary OraVescent transmucosal drug delivery technology. Pharmacokinetic studies conducted late in 2002 indicated that OraVescent Fentanyl is faster acting and provides greater absorption than the leading Fentanyl treatment.

About CIMA

CIMA develops and manufactures prescription and over-the-counter products based upon its proprietary, orally disintegrating drug delivery technologies, OraSolv(R) and DuraSolv(R). Based on these technologies, an active drug ingredient, which the Company frequently taste-masks, is formulated into a new, orally disintegrating dosage form that dissolves quickly in the mouth without chewing or the need for water. The Company develops and manufactures orally disintegrating versions of drugs for pharmaceutical company partners for whom CIMA currently produces three branded prescription pharmaceuticals and three over-the-counter brands. CIMA is also developing proprietary products utilizing its orally disintegrating technologies, as well as its new OraVescent(R) enhanced absorption, transmucosal drug delivery technology.

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 within the meaning of the "Safe Harbor" provisions 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 are based on the current expectations and beliefs of CIMA's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The forward-looking statements contained in this press release include statements about future financial and operating results, the proposed merger of aaiPharma and CIMA, and a potential meeting with the U.S. Food and Drug Administration (FDA) regarding OraVescent Fentanyl. These statements are not guarantees of future performance, involve certain risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. Therefore, actual outcomes and results may differ materially from what is expressed herein.

In any forward-looking statement in which CIMA expresses an expectation or belief as to future results, that expectation or belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be achieved or accomplished. Risks and uncertainties pertaining to the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: unexpected costs related to the merger or 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.
; the impact of uncertainty surrounding the merger on CIMA's business; the impact of competition, new data, supply issues or marketplace trends on the market for CIMA's products; technical, regulatory or manufacturing issues, new data or intellectual property disputes that may affect CIMA's programs; the ability to develop and market products in a timely manner; and difficulties in gaining approval of new products. Additional economic, business, competitive and/or regulatory factors affecting CIMA's business generally that may cause actual results to differ materially are discussed in its filings with the Securities and Exchange Commission, including its 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 fiscal year ended December 31, 2002, especially in the 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
 section, its most recent Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 and its Current Report 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.
. CIMA does not undertake any obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 9, 2003
Words:1133
Previous Article:MFIC Corporation Comments on Stock Price and Volume Improvement, on Current Operations, and MMR Program Progress.
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