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Wednesday June 19, 4:01 pm Eastern Time
Press Release
SOURCE: Genzyme General
Genzyme General Revises 2002 Financial Guidance
CAMBRIDGE, Mass., June 19 /PRNewswire-FirstCall/ -- Genzyme General (Nasdaq: GENZ - News), a division of Genzyme Corp., today revised its financial guidance for the second quarter and for the full year. The new guidance includes lower revenue expectations for Renagel® (sevelamer hydrochloride) and diagnostic products and increased expectations for Cerezyme® (imiglucerase for injection) and other therapeutic products. The new Renagel guidance reflects a better understanding of the near-term growth pattern for the product. Genzyme now projects that Renagel's growth rate will reaccelerate beginning in the second half of this year.
"The catalysts for Renagel's growth are in place," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "We now have a clearer sense of the timing of their impact on the acceleration of the product's adoption curve. The longer-term potential for Renagel continues to be tremendous. We remain highly confident in our outlook for the product and in the fundamental strength of all of our businesses."
For 2002, Genzyme General now expects total revenues of between $1.10-$1.15 billion, approximately 4 percent lower than the previous guidance range. Diluted earnings per share attributable to Genzyme General stock are expected in the range of $1.18-$1.23, prior to amortization and one-time events. Earnings for the second quarter of 2002 are expected to be in the range of $.25-$.26 per share.
Renagel sales for the year are now expected to be between $200-$210 million, compared to previous guidance of $260-$280 million. For the second quarter, Renagel revenues are expected to be approximately $40 million, reflecting some continued reduction of higher-than-anticipated wholesaler inventory. Genzyme has taken steps to better understand the buying patterns of its Renagel wholesalers, and it will establish new controls based on this analysis.
Genzyme has also made progress this year in a number of other areas key to Renagel's growth. In the manufacturing area, it successfully completed the installation of a second tableting line at its existing contract manufacturer and is on track to qualify a third line next quarter at a backup contract manufacturer. It also has installed the equipment at its new tableting facility in Waterford, Ireland, and is performing the final qualifying production runs at its new bulk sevelamer manufacturing facility in Haverhill, U.K, in preparation for regulatory approval of the plant in the second half of this year.
In addition, Genzyme has completed the expansion of its Renagel sales force, which now stands at 80 people (up from 48) in the United States and 76 (up from 44) in Europe. Most of the new sales representatives have completed training and have begun calling on clinicians and dialysis centers. The impact of the sales force expansion will begin to be felt later this year. In Europe, Genzyme continues to make excellent progress with the introduction of the 800 mg Renagel tablet.
In Brazil, Genzyme recently received reimbursement approval for Renagel. Genzyme continues to finalize labeling details and expects to receive its first order from the federal government in Brazil soon.
A draft of the new K/DOQI clinical guidelines on managing bone disease and mineral metabolism in dialysis patients is now expected to be available in July, approximately six months later than expected originally. Publication of a final set of guidelines is not expected until the beginning of next year.
Genzyme's Treat to Goal study comparing Renagel with calcium-based phosphate binders will be published in July, and the impact of the data will begin to be felt later in the year as the paper becomes widely available.
Other Adjustments to Guidance
Genzyme raised its 2002 guidance for Cerezyme® (imiglucerase for injection) from $580-$600 million to $600-$610 million, based on an increase in the number of patients on therapy. Genzyme also increased its combined revenue guidance for other therapeutic products, including Thyrogen® (thyrotropin alfa for injection), WelChol(TM) (colesevelam hydrochloride), and pharmaceutical intermediates, from $85-$100 million to $90-$105 million.
Genzyme confirmed its previous revenue guidance for Fabrazyme(TM) (agalsidase beta) of between $25-$40 million. This forecast is based on Fabrazyme sales in Europe and other markets outside the United States. Genzyme remains confident that it will receive approval to market Fabrazyme in the United States this year.
Revenue expectations for Genzyme General's diagnostics businesses were reduced slightly from $180-$185 million to $175-$185 million.
Please see the attached table for additional details on Genzyme General's revised guidance.
Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has five therapeutic products on the market and a strong pipeline of therapeutic products in development focused on the treatment of genetic diseases and other chronic debilitating disorders with well-defined patient populations. Genzyme General is a division of Genzyme Corp.
This press release contains forward-looking statements, including statements about: Genzyme General's anticipated revenues and earnings per share for the year 2002 and the second quarter of 2002; anticipated Renagel sales for the second quarter of 2002 and for the year 2002; the expected drivers for Renagel sales; expectations concerning Renagel's growth and future demand for the product; manufacturing plans; the anticipated timing of shipments of Renagel from a contract manufacturer; the anticipated timing of qualifying runs and receipt of regulatory approvals for facilities; expectations concerning the performance of the sales force for Renagel; the potential receipt of an order from the federal government in Brazil and the anticipated timing thereof; expectations concerning publication of the K/DOQI clinical guidelines and data from the Treat to Goal study and the anticipated impact thereof; anticipated revenues for Genzyme General's products for the year 2002, including Cerezyme, Thyrogen, WelChol, pharmaceutical intermediates and Fabrazyme; the potential receipt of U.S. marketing approval for Fabrazyme and the anticipated timing thereof; and expected 2002 revenues from Genzyme General's diagnostics businesses. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: the ability to increase and sustain market acceptance of Renagel and to do so in a manner consistent with the anticipated timing; the ability to improve patient compliance and optimize dosing of Renagel; the accuracy of Genzyme General's information about the markets for Renagel, including growth projections and competitive products and product candidates; the actual impact of the publication of K/DOQI guidelines and the data from the Treat to Goal study on decisions made by physicians and on Renagel sales; the results and timing of qualifying runs at facilities; the actual timing and content of submissions to and decisions made by regulatory authorities manufacturing facilities for Renagel, Fabrazyme, and Genzyme General's other products and services; the results of clinical trials; the availability and extent of reimbursement from third-party payers for Renagel and Genzyme General's other products and services; the ability to manufacture sufficient quantities of Renagel and Genzyme General's other products for development and commercialization activities and to do so in a timely and cost efficient manner; the actual results of Genzyme General's total operations in 2002; Genzyme General's ability to identify additional patients for its products and services; the effectiveness of Genzyme General's sales force for Renagel and other products; the competitive environment for Genzyme General's products and services; the FDA's response to the clarification and additional data provided by Genzyme related to the BLA for Fabrazyme; Genzyme's ability to adequately respond to additional requests for data or clarification that may be made by the FDA, if any, related to the BLA for Fabrazyme; the ability to maintain distribution, licensing and supply agreements; and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation Exhibit 99.2 to Genzyme's 2001 Annual Report on Form 10-K. Genzyme General Division common stock is a series of common stock of Genzyme Corporation. Therefore, holders of Genzyme General Division common stock are subject to all of the risks and uncertainties described in the those reports. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements.
Genzyme®, Cerezyme®, Thyrogen® are registered trademarks and Fabrazyme(TM) is a trademark of Genzyme Corporation. Renagel® is a registered trademark of GelTex Pharmaceuticals, Inc. WelChol(TM) is a trademark of Sankyo Pharma Inc. All rights reserved.
Conference Call Information
Genzyme will host a conference call today at 5:00 p.m. Eastern to discuss its revised financial guidance for 2002. To participate in the call, please dial 719-457-2728. A replay of the call will be available from 8:00 p.m. Eastern today through midnight on June 26. To listen to the replay, please dial 719-457-0820 and use pass code 160933. Today's call also can be heard live on Genzyme's Web site at www.genzyme.com/corp/investors/events_home.asp. The call will be available on the Web site through June 26.
Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States. |
