GENZ » Topics » Table of Contents

This excerpt taken from the GENZ 10-K filed Mar 1, 2010.

Table of Contents

    our expectations regarding the amortization of intangible assets related to our expected future contingent payments due to Bayer Schering Pharma A.G., or Bayer, Synpac (North Carolina), Inc., or Synpac, and Wyeth.

        These statements are subject to risks and uncertainties, and our actual results may differ materially from those that are described in this report. These risks and uncertainties include:

    the possibility that we may encounter additional manufacturing problems due to any reason, including mechanical failures, viral or bacterial contamination, cell growth at lower than expected levels, fill-finish issues, or regulatory issues;

    the possibility that we may be unable to produce new sevelamer hydrochloride and/or new sevelamer carbonate at our Haverhill, England facility in the expected time frames due to production problems or regulatory issues;

    the extent to which Gaucher and Fabry disease patients switch to competitors' products in place of Cerezyme or Fabrazyme or continue to reduce their doses of our products even after product supply stabilizes;

    our ability to maintain regulatory approvals for our products, services and manufacturing facilities and processes including our Allston facility; and to obtain approvals in the anticipated timeframes, including United States Food and Drug Administration, or FDA, approval of alglucosidase alfa produced at the 4000L scale, new manufacturing capacity and proposed changes to enhance our manufacturing processes;

    our ability to manufacture sufficient amounts of our products and maintain sufficient inventories, and to do so in a timely and cost-effective manner;

    our ability and the ability of our collaboration partners to successfully complete preclinical and clinical development of new products and services;

    our ability to expand the use of current and next generation products in existing and new indications;

    regulatory authorities' views regarding the safety, efficacy and risk-benefit profiles of our new or current products and our manufacturing processes;

    potential future write offs of inventory or product recalls;

    our ability to satisfy the post-marketing commitments made to regulatory agencies as a condition of the marketing approvals of Fabrazyme, Aldurazyme, Myozyme, Clolar and Mozobil;

    the availability of reimbursement for our products and services from third party payors, the extent of such coverage and the accuracy of our estimates of the payor mix for our products;

    the accuracy of our information regarding the products and resources of our competitors and potential competitors;

    competition from lower cost generic or biosimilar products;

    the impact of legislative or regulatory changes, including proposed healthcare reform in the United States;

    our ability to obtain and maintain adequate patent and other proprietary rights protection for our products and services and successfully enforce these proprietary rights;

    our reliance on third parties to provide us with materials and services in connection with the manufacture of our products;

3


Table of Contents

    the accuracy of our estimates of the size and characteristics of the markets to be addressed by our products and services, including growth projections;

    market acceptance of our products and services in expanded areas of use and new markets;

    our ability to successfully identify and market our products and services to new patients;

    our ability to effectively manage wholesaler inventories of our products and the levels of their compliance with our inventory management programs;

    our ability to continue to generate cash from operations and to effectively use our cash resources to grow our business;

    our ability to establish and maintain strategic license, collaboration and distribution arrangements and to successfully manage our relationships with licensors, collaborators, distributors and partners;

    the impact of changes in the exchange rates for foreign currencies on our product and service revenues in future periods;

    the outcome of legal proceedings by or against us;

    the possibility that our integration of the products and development programs acquired from Bayer may be more costly or time consuming than expected;

    the outcome of our IRS and foreign tax audits;

    general economic conditions; and

    the possible disruption of our operations due to terrorist activities, armed conflict, severe climate change or outbreak of diseases, including as a result of the disruption of operations of regulatory authorities, our subsidiaries, manufacturing facilities, customers, suppliers, distributors, couriers, collaborative partners, licensees or clinical trial sites.

        We refer to more detailed descriptions of these and other risks and uncertainties under the heading "Risk Factors" in Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations in Part II, Item 7 of this Form 10-K. We encourage you to read those descriptions carefully. We caution investors not to place substantial reliance on the forward-looking statements contained in this Form 10-K. These statements, like all statements in this Form 10-K, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.

This excerpt taken from the GENZ 10-Q filed May 11, 2009.

Table of Contents

    our ability to expand the use of current and next generation products in existing and new indications;

    our ability to obtain and maintain regulatory approvals for our products, services and manufacturing facilities and processes, and to do so in the anticipated timeframes, including our ability to obtain regulatory approvals for an expanded Renvela label and for alglucosidase alfa produced at the 2000L and 4000L scale in the United States and the timing of receipt of such approvals;

    regulatory authority views regarding the safety, efficacy and risk-benefit profiles of our products;

    the content and timing of submissions to and decisions made by the FDA, the European Agency for the Evaluation of Medicinal Products, or EMEA, and other regulatory agencies related to our products and services and the facilities and processes used to manufacture our products, including the timing and outcome of the FDA's re-inspection of our Allston, Massachusetts facility;

    our ability to accurately forecast the impact of regulatory delays on our financial position and results of operations;

    our ability to manufacture sufficient amounts of our products for development and commercialization activities and to do so in a timely and cost-effective manner;

    potential future write-offs of inventory or product recalls;

    our ability to satisfy the post-marketing commitments made to regulatory agencies as a condition of the marketing approvals of Fabrazyme, Aldurazyme, Myozyme, Clolar and Mozobil;

    our ability to obtain and maintain adequate patent and other proprietary rights protection for our products and services and successfully enforce these proprietary rights;

    our reliance on third parties to provide us with materials and services in connection with the manufacture of our products;

    the accuracy of our estimates of the size and characteristics of the markets to be addressed by our products and services, including growth projections;

    market acceptance of our products and services in expanded areas of use and new markets;

    our ability to successfully identify and market our products and services to new patients;

    our ability to increase market penetration of our products and services both outside and within the United States;

    the accuracy of our information regarding the products and resources of our competitors and potential competitors;

    competition from lower cost generic or biosimilar products;

    the availability of reimbursement for our products and services from third party payors, the extent of such coverage and the accuracy of our estimates of the payor mix for our products;

    our ability to effectively manage wholesaler inventories of our products and the levels of their compliance with our inventory management programs;

    our ability to continue to generate cash from operations and to effectively use our cash resources to grow our business;

3


Table of Contents

    our ability to establish and maintain strategic license, collaboration and distribution arrangements and to successfully manage our relationships with licensors, collaborators, distributors and partners;

    the impact of changes in the exchange rates for foreign currencies on our product and service revenues in future periods;

    the resolution of our dispute with our insurance carriers regarding our claim for coverage under a director and officer liability insurance program;

    the outcome of legal proceedings by or against us;

    the impact of our recent and future merger and acquisition activity;

    the receipt of regulatory approvals for our transaction with Bayer and our ability to successfully integrate the products and development programs that we would acquire from Bayer;

    the outcome of our IRS and foreign tax audits;

    general economic conditions; and

    the possible disruption of our operations due to terrorist activities, armed conflict, severe climate change or outbreak of diseases, including as a result of the disruption of operations of regulatory authorities, our subsidiaries, manufacturing facilities, customers, suppliers, distributors, couriers, collaborative partners, licensees or clinical trial sites.

        We refer to more detailed descriptions of these and other risks and uncertainties under the heading "Risk Factors" in Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations in Part I, Item 2 of this Form 10-Q. We encourage you to read those descriptions carefully. We caution investors not to place substantial reliance on the forward-looking statements contained in this Form 10-Q. These statements, like all statements in this Form 10-Q, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.

This excerpt taken from the GENZ DEF 14A filed Apr 13, 2009.

Table of Contents


NOTICE OF ANNUAL MEETING OF SHAREHOLDERS OF GENZYME CORPORATION

Date:   Thursday, May 21, 2009

Time:

 

2:00 - 4:00 p.m.

Place:

 

Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02142

Purpose:

 

We are holding the annual meeting for shareholders to consider four company sponsored proposals as follows:

 

 


 

The re-election of eight directors, each for a one-year term;

 

 


 

An amendment to our 2004 Equity Incentive Plan to increase the number of shares of common stock available for issuance under the plan by 2,500,000 shares;

 

 


 

Approval of the 2009 Employee Stock Purchase Plan; and

 

 


 

The ratification of our audit committee's selection of independent auditors.

 

 

We will also consider action on any other matter that may be properly brought before the meeting.

Only shareholders of record at the close of business on March 31, 2009 will be entitled to vote at the meeting.

This excerpt taken from the GENZ 10-Q filed Aug 11, 2008.

Table of Contents

    our expectations regarding the amortization of intangible assets related to our expected future contingent payments due to Synpac (North Carolina), Inc. and Wyeth.

        These statements are subject to risks and uncertainties, and our actual results may differ materially from those that are described in this report. These risks and uncertainties include:

    our ability to successfully complete preclinical and clinical development of our products and services;

    our ability to secure regulatory approvals for our products, services and manufacturing facilities, and to do so in the anticipated timeframes, including our ability to obtain and maintain regulatory approvals for alglucosidase alfa (Myozyme®) produced at the 2000L scale in the United States and 4000L scale in Europe and the timing of these anticipated approvals;

    the content and timing of submissions to and decisions made by the FDA, the EMEA, and other regulatory agencies related to our products and services and the facilities and processes used to manufacture our products;

    our ability to accurately forecast the impact of regulatory delays on our revenues, costs and earnings;

    our ability to manufacture sufficient amounts of our products for development and commercialization activities and to do so in a timely and cost-effective manner, including our ability to manufacture Thymoglobulin that meets our product specifications and in quantities sufficient to meet projected market demand and our ability to manufacture Myozyme at the 2000L and 4000L scales;

    our ability to satisfy the post-marketing commitments made as a condition of the marketing approvals of Fabrazyme, Aldurazyme, Myozyme and Clolar;

    our reliance on third parties to provide us with materials and services in connection with the manufacture of our products;

    the accuracy of our estimates of the size and characteristics of the markets to be addressed by our products and services, including growth projections;

    market acceptance of our products and services in expanded areas of use and new markets;

    our ability to identify new patients for our products and services;

    our ability to increase market penetration of our products and services both outside and within the United States;

    the accuracy of our information regarding the products and resources of our competitors and potential competitors;

    competition from lower cost generic or follow-on products;

    the availability of reimbursement for our products and services from third party payors, the extent of such coverage and the accuracy of our estimates of the payor mix for our products;

    our ability to effectively manage wholesaler inventories of our products and the levels of their compliance with our inventory management programs;

    our use of cash in business combinations or other strategic initiatives;

    the resolution of our dispute with our insurance carriers regarding our claim for coverage under a director and officer liability insurance program;

    the outcome of legal proceedings by or against us;

3


Table of Contents

    our ability to successfully integrate the business we acquired from Bioenvision, Inc., or Bioenvision;

    the outcome of our IRS and foreign tax audits; and

    the possible disruption of our operations due to terrorist activities, armed conflict, severe climate change or outbreak of diseases, including as a result of the disruption of operations of regulatory authorities, our subsidiaries, manufacturing facilities, customers, suppliers, distributors, couriers, collaborative partners, licensees or clinical trial sites.

        We have included more detailed descriptions of these and other risks and uncertainties under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Risk Factors," in Part I., Item 2. of this Quarterly Report on Form 10-Q. We encourage you to read those descriptions carefully. We caution investors not to place substantial reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.

Wikinvest © 2006, 2007, 2008, 2009, 2010, 2011, 2012. Use of this site is subject to express Terms of Service, Privacy Policy, and Disclaimer. By continuing past this page, you agree to abide by these terms. Any information provided by Wikinvest, including but not limited to company data, competitors, business analysis, market share, sales revenues and other operating metrics, earnings call analysis, conference call transcripts, industry information, or price targets should not be construed as research, trading tips or recommendations, or investment advice and is provided with no warrants as to its accuracy. Stock market data, including US and International equity symbols, stock quotes, share prices, earnings ratios, and other fundamental data is provided by data partners. Stock market quotes delayed at least 15 minutes for NASDAQ, 20 mins for NYSE and AMEX. Market data by Xignite. See data providers for more details. Company names, products, services and branding cited herein may be trademarks or registered trademarks of their respective owners. The use of trademarks or service marks of another is not a representation that the other is affiliated with, sponsors, is sponsored by, endorses, or is endorsed by Wikinvest.
Powered by MediaWiki