-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DjcdBnqrBne03NQGwflH+prdhJ+sFHfUAxFSxwySaYqM3He7uwXWQIDjHU1AoCr4 wZd73n07gcXFnLpERzBJMQ== 0001104659-07-076558.txt : 20071024 0001104659-07-076558.hdr.sgml : 20071024 20071024101436 ACCESSION NUMBER: 0001104659-07-076558 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071024 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071024 DATE AS OF CHANGE: 20071024 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENZYME CORP CENTRAL INDEX KEY: 0000732485 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061047163 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14680 FILM NUMBER: 071187105 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6172527500 MAIL ADDRESS: STREET 1: ONE KENDALL SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 a07-27341_18k.htm 8-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D. C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED):

October 24, 2007

GENZYME CORPORATION

(Exact name of registrant as specified in its charter)

Massachusetts

 

0-14680

 

06-1047163

(State or other jurisdiction of

 

(Commission file number)

 

(IRS employer identification

incorporation or organization)

 

 

 

number)

 

500 Kendall Street, Cambridge, Massachusetts  02142

(Address of Principal Executive Offices)  (Zip Code)

Registrant’s telephone number, including area code:

(617) 252-7500

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o          Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o          Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o          Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



 

Item 2.02               Results of Operations and Financial Condition.

 

On October 24, 2007, Genzyme Corporation issued a press release containing its results of operations and financial condition for the three month period ended September 30, 2007.  A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The press release furnished herewith includes certain non-GAAP financial measures that involve adjustments to GAAP figures.  Genzyme believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Genzyme’s past financial performance and its prospects for the future.  The non-GAAP financial measures are included with the intent of providing both management and investors with a more complete understanding of underlying operational results and trends.  In addition, these non-GAAP financial measures are among the primary indicators Genzyme management uses for planning and forecasting purposes and measuring the company’s performance.  These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP figures.  A reconciliation of the non-GAAP to GAAP figures can be found following the text of the press release.

 

Item 9.01                                             Financial Statements and Exhibits.

(d)                                                 Exhibits

99.1                                             Press Release of Genzyme Corporation dated October 24, 2007.

 

 

2



 

SIGNATURE

                    Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

GENZYME CORPORATION

 

 

 

 

 

Dated: October 24, 2007

 

By:

/s/ Michael S. Wyzga

 

 

 

 

Michael S. Wyzga

 

 

 

 

Executive Vice President, Finance;

 

 

 

 

Chief Financial Officer; and

 

 

 

 

Chief Accounting Officer

 

 

 

3


EX-99.1 2 a07-27341_1ex99d1.htm EX-99.1

Exhibit 99.1

 

For Immediate Release

Media Contact:

Investor Contact:

October 24, 2007

Bo Piela
(617) 768-6579

Sally Curley
(617) 768-6140

 

Genzyme Reports Strong Earnings Growth in Third Quarter

 


 

Non-GAAP EPS Grew 23 Percent

 

CAMBRIDGE, Mass. – Genzyme Corporation (NASDAQ: GENZ) today reported a significant increase in third-quarter non-GAAP profit. The increase was driven once again by strong sales and continued operating leverage. Revenue grew 19 percent to $960.2 million from $808.6 million in the same period a year ago, reflecting continued momentum across most product areas.

 

GAAP net income rose to $159.3 million, or $0.58 per diluted share, compared with $16.0 million, or $0.06 per diluted share, in the quarter a year ago.

 

Non-GAAP net income grew 23 percent to $241.3 million, or $0.90 per diluted share, from $195.9 million, or $0.73 per diluted share, in the same period last year. Non-GAAP figures for this year’s third quarter exclude pre-tax stock-compensation expenses of $44.4 million, amortization of $49.8 million, a charge of $19.2 million related to the acquisition of Bioenvision Inc., a manufacturing-related charge of $11.8 million, and the effect of contingent convertible debt.

 

Genzyme said in July that it expects non-GAAP earnings to grow at a compound average of 20 percent during the five-year period from 2006 through 2011. The company added today that it expects non-GAAP earnings to increase to approximately $4.00 per diluted share next year and that earnings are projected to rise to approximately $7.00 per diluted share by 2011. Genzyme’s growth over this period is

 

(more)

 



 

being led by three key drivers: increasing sales of existing products, the launch of new products now approaching the market, and continued operating leverage from the company’s global infrastructure.

 

“We grew earnings at a compound average of more than 20 percent over the past decade, and we are committed to delivering a similarly strong rate of growth over the next five-year period,” said Chairman and Chief Executive Officer Henri A. Termeer.

 

During the third quarter, Genzyme generated approximately $280 million in cash from operations. The company is using a portion of its cash from operations to repurchase shares under a three-year program intended to reduce the dilutive effect of equity compensation programs. Since the program began in the second quarter, the company has spent $181.2 million to repurchase 2.8 million shares.

 

Genzyme continues to make excellent progress in building its businesses to drive future growth, and the past three months have been particularly productive. The company obtained marketing approvals for three new products; expanded its oncology franchise by securing worldwide rights to its leukemia drug clofarabine; and reported highly encouraging results for the two most prominent product candidates in its pipeline— Mozobil (plerixafor) and alemtuzumab for multiple sclerosis. Highlights for the period include the following:

 

—The FDA approved Renvela® (sevelamer carbonate) for chronic kidney disease patients on dialysis, marking the first step in Genzyme’s program to expand the use of sevelamer to a broader set of patients and drive the product’s long-term growth. The company expects to launch Renvela for dialysis patients during the first quarter of next year. It also plans to seek FDA approval in the first half of next year for Renvela’s use by patients with earlier stages of chronic kidney disease. An FDA advisory committee voted this week to recommend that the agency extend the indications for phosphate binders to include pre-dialysis patients with hyperphosphatemia.

 

2



 

—Genzyme is preparing to launch two products that will add incrementally to the top line while primarily utilizing existing sales and marketing resources. Specifically, the company won approval in Japan to market Elaprase (idursulfase) for the treatment of Hunter syndrome. Elaprase is being commercialized by Genzyme in Asia under an agreement with Shire Human Genetic Therapies Inc. In addition, Genzyme obtained European Union clearance to market Cholestagel® (colesevelam hydrochloride), a cholesterol-lowering agent for the treatment of primary hypercholesterolemia.

 

—Genzyme completed its acquisition of Bioenvision following a favorable merger vote by Bioenvision shareholders earlier this week. The transaction provides Genzyme with worldwide rights for clofarabine, which is currently approved in the United States for the treatment of acute lymphoblastic leukemia in relapsed and refractory pediatric patients. Genzyme is developing clofarabine for significantly larger indications, including use as a first-line therapy for the treatment of adult acute myeloid leukemia. The company expects to file for such an indication in the United States next year.

 

The FDA approved expanded labeling for Campath® (alemtuzumab) to include first-line treatment of B-cell chronic lymphocytic leukemia, significantly increasing the number of patients eligible to receive the product. European approval of an expanded indication is expected this year, following the positive opinion issued this month by the Committee for Medicinal Products for Human Use.

 

—Genzyme reported top-line three-year results from a completed Phase 2 clinical trial comparing alemtuzumab with Rebif® (interferon beta-1a) for the treatment of multiple sclerosis. The study showed that patients taking alemtuzumab experienced at least a 73 percent reduction in the risk for relapse and at least a 70 percent reduction in the risk for progression of clinically significant disability after three years of follow up, when compared to patients treated with interferon beta-1a. The data also showed that mean disability scores improved from baseline in the alemtuzumab patients and declined in the Rebif patients. Genzyme and Bayer Schering Pharma AG, Germany, have begun enrolling patients in two Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis.

 

—Genzyme also reported that both of its pivotal trials of Mozobil met their primary endpoints and that the company would file in the first half of 2008 for U.S. and European approval for the product’s use in treating patients with multiple myeloma and patients with lymphoma. Genzyme plans to launch the product early in 2009. Mozobil is an innovative product intended to facilitate and improve the outcome of stem-cell transplantation procedures. Genzyme expects peak sales of Mozobil in the transplant setting of $400 million, and the company is exploring additional indications for the product, including chemosensitization procedures. Results from the pivotal studies of Mozobil will be presented at the American Society of Hematology annual meeting in December.

 

3



 

Therapeutics

 

Sales of Myozyme® (alglucosidase alfa) rose to $53.6 million, compared with $20.4 million in the same period a year ago. Genzyme expects to submit an application to the FDA by the end of this month for approval of a larger scale manufacturing process to supply Myozyme for the U.S. market. An agency decision is expected in the first quarter of next year. Production at this larger scale is already approved by more than 30 countries. To ensure that treatment is available to all U.S. patients who need it, Genzyme is managing a temporary clinical access program through which patients may receive Myozyme produced at the larger scale. The study of Myozyme involving patients with late-onset Pompe disease will conclude this year, and results will be submitted to regulatory authorities by the middle of next year.

 

Sales of Fabrazyme® (agalsidase beta) increased 12 percent to $104.6 million, compared with $93.2 million in the same quarter last year. Sales of Cerezyme® (imiglucerase for injection) grew 13 percent to $286.1 million, compared with $252.2 million in the third quarter a year ago. Sales of Aldurazyme® (laronidase) grew 29 percent to $32.3 million, compared with $25.0 million in last year’s third quarter. Aldurazyme is marketed through a joint venture with BioMarin Pharmaceutical Inc.

 

Genzyme has completed enrollment in the Phase 2 trial of the small molecule Genz-112638, a novel oral therapy being developed for the treatment of Gaucher disease. Initial observations from the first group of patients enrolled in this open-label study were highly encouraging, and Genzyme has requested a meeting with the FDA to discuss an expedited development strategy. The company believes this product could reach the market within 3-4 years and provide an additional treatment option for physicians and Gaucher patients.

 

4



 

Sales of Thyrogen® (thyrotropin alfa for injection) grew 20 percent in the third quarter to $26.8 million, compared with $22.4 million in the period a year ago. Genzyme expects U.S. approval for Thyrogen’s use in thyroid cancer remnant ablation procedures this year.

 

Renal

 

Within the Renal business, sales of Renagel® (sevelamer hydrochloride) rose 14 percent to $154.2 million, up from $134.7 million in the third quarter a year ago. The clinical evidence supporting Renagel is allowing the product to retain pricing power and increase market share in the competitive and growing market for phosphate binders. Results from the Dialysis Clinical Outcomes Revisited (D-COR) study of Renagel were published online in Kidney International in August and in the journal itself this month. The study compared mortality and morbidity outcomes for patients on Renagel and patients receiving calcium-based phosphate binders.

 

Sales of Hectorol® (doxercalciferol) rose 19 percent to $30.3 million from $25.5 million a year ago. The most significant growth was in the 0.5 microgram capsule, the dose indicated for chronic kidney disease patients who are not on dialysis. Hectorol is enabling Genzyme to establish itself in this market prior to the introduction of Renvela for a pre-dialysis indication.

 

Transplant

 

Sales of Thymoglobulin® (anti-thymocyte globulin, rabbit) and Lymphoglobuline® (anti-thymocyte globulin, equine) rose 9 percent in the third quarter to $41.0 million, compared with $37.6 million in the same period last year.

 

5



 

Biosurgery

 

Within the Biosurgery unit, third-quarter sales of Synvisc (hylan G-F 20) grew 9 percent to $61.2 million, compared with sales of $55.9 million in last year’s third quarter. Genzyme anticipates U.S. and European regulatory action this year on its marketing applications for the single-injection regimen Synvisc-One. The company is confident that this product—delivered through a single knee injection—will simplify osteoarthritis pain management, reduce the overall cost of therapy and offer a treatment option that may dynamically expand the benefits of viscosupplementation to a broader number of patients.

 

Additionally, Genzyme plans to pursue CE Mark approval for hylastan in the European Union. Hylastan is an alternatively formulated viscosupplementation product that, like Synvisc-One, was designed to simplify osteoarthritis pain management by reducing the number of required knee injections. Genzyme expects to submit an application to European regulatory authorities in the first half of next year.

 

Sales of Sepra® products rose 25 percent to $26.4 million in the third quarter, up from $21.1 million in last year’s third quarter. This increase is somewhat greater than in previous quarters and reflects the growing use of Seprafilm® adhesion barrier in larger markets such as gynecologic surgery. Genzyme’s expanded U.S. Sepra sales force is helping to broaden use of the product

 

Genetic Diagnostics

 

Genetics revenue grew 19 percent in the third quarter to $73.1 million, up from $61.4 million in the same quarter last year. The Genetics business has been experiencing strong growth, driven by an increasing demand for diagnostic testing services. Genzyme is investing in additional information technology and infrastructure to continue to strengthen the competitive advantages the Genetics unit has created.

 

6



 

Other

 

Other revenue increased 25 percent in the third quarter to $82.3 million, compared with $66.1 million in the same quarter last year. Other revenue includes sales of diagnostic products and pharmaceutical intermediates, royalties from the sale of WelChol® (colesevelem hydrochloride), and oncology revenue.

 

Oncology revenue increased 38 percent to $22.7 million from $16.5 million in the third quarter a year ago. Oncology revenue includes sales of Clolar® (clofarabine for injection) and profits and royalties for Campath.

 

Expenses

 

Third-quarter non-GAAP operating expenses increased 14 percent compared with the same quarter last year, while revenue grew 19 percent, underscoring the leverage Genzyme is gaining from its global commercial infrastructure. Non-GAAP selling, general and administrative expenses were $245.2 million compared to $214.9 million in the third quarter last year. Non-GAAP SG&A spending represented 26 percent of revenue in the quarter, down from 27 percent in the third quarter last year.

 

Non-GAAP research and development spending rose to $162.3 million in the third quarter, up from $143.0 million in last year’s third quarter, reflecting increased spending on late-stage programs. Non-GAAP R&D spending represented 17 percent of revenue, consistent with recent quarters.

 

As noted, Genzyme recorded an $11.8 million manufacturing-related charge during the quarter, which reflects the write off of four finished lots of Thymoglobulin that did not meet the company’s specifications. Several additional finished lots of the product are currently under review to determine whether they meet quality specifications.

 

7



 

About Genzyme

 

One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.

 

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and diagnostic testing. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease and other areas of unmet medical need.

 

This press release contains forward-looking statements regarding Genzyme’s financial outlook and business plans and strategies, including: its non-GAAP earnings estimate for 2008 and 2011; its expectation of a 20% compound average non-GAAP earnings growth rate through 2011; and its product development plans and timelines and regulatory filing and action estimates, including the timing of the launch of Renvela for dialysis patients, the timing of the US filing for the use of Renvela by patients with earlier stages of CKD, the timing of the US filing for use of Clolar as a first-line treatment in adult AML, the receipt of European approval of Campath as a first-line treatment in B-CLL,  the timing of the launch of Mozobil in multiple myeloma and non-Hodgkin’s lymphoma and the expected peak product revenues in the transplant setting, the timing of GENZ-112638 product launch, the timing of the receipt of FDA approval for Thyrogen in thyroid cancer ablation, and the timing of the receipt of FDA approval for a larger-scale Myozyme manufacturing process. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: Genzyme’s ability to successfully

 

8



 

complete preclinical and clinical development of its products; Genzyme’s ability to expand the use of current products in existing and new indications; Genzyme’s ability to obtain and maintain regulatory approvals for products and manufacturing facilities, including the larger-scale production of Myozyme and the timing of receipt of such approvals; Genzyme’s ability to manufacture products and product candidates in a timely and cost effective manner and in sufficient quantities to meet demand; Genzyme’s ability to maintain and enforce intellectual property rights; Genzyme’s ability to successfully identify and market to new patients; the scope of third-party reimbursement coverage for Genzyme’s products and services; and the risks and uncertainties described in Genzyme’s SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption “Risk Factors” in Genzyme’s Quarterly Report on Form 10-Q for the period ended June 30, 2007. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today’s date and Genzyme undertakes no obligation to update or revise the statements.

 

Genzyme®, Myozyme®, Fabrazyme®, Cerezyme®, Thyrogen®, Renagel®, Hectorol®, Thymoglobulin®, Lymphoglobuline®, Synvisc®, Sepra®, Seprafilm®, Campath® and Clolar® are registered trademarks and Mozobil™, Renvela™, Hylastan™ are trademarks of Genzyme Corporation or its subsidiaries. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. Elaprase™ is a trademark of Shire Human Genetic Therapies Inc. WelChol® is a trademark of Sankyo Pharma. All rights reserved.

 

Conference Call Information

 

Genzyme Corporation will host a conference call today at 11:00 a.m. Eastern Time to discuss third-quarter financial results.  To participate in the call, please dial 773-799-3828 and refer to pass code “Genzyme.”  A replay of this call will be available by dialing 402-998-1342.  This call will also be Webcast live on the investor events section of www.genzyme.com.  Replays of the call and the Webcast will be available until midnight on October 31, 2007.

 

Upcoming Events

 

Genzyme Corporation will host a conference call February 13, 2008, at 11:00 a.m. Eastern Time to discuss four-quarter financial results.  To participate in the call, please dial 773-799-3828 and refer to pass code “Genzyme.”  A replay of this call will be available by dialing 203-369-1503. This call will also be Webcast live on the investor events section of www.genzyme.com.  Replays of the call and the Webcast will be available until midnight February 20, 2008.

 

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 1-678-999-4572 outside the United States.

 

# # #

 

9



 

GENZYME CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP EARNINGS
For the Quarter Ended September 30, 2007
(Amounts in thousands, except per share data)

 

 

 

 

 

 

Dilution

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Due to

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock

 

Manufacturing

 

Acquisition

 

 

 

FAS 123R

 

GAAP

 

 

 

NON-GAAP

 

Equivalents

 

Related

 

Related

 

Amortization

 

Expense

 

As Reported

 

Income Statement Classification:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

960,159

 

 

 

 

 

 

 

 

 

 

 

$

960,159

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of products and services sold

 

$

(227,060

)

 

 

$

(11,773

)

 

 

 

 

$

(5,779

)

$

(244,612

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

$

(245,215

)

 

 

 

 

 

 

 

 

$

(25,091

)

$

(270,306

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

(162,282

)

 

 

 

 

 

 

 

 

$

(13,518

)

$

(175,800

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangibles

 

$

 

 

 

 

 

 

 

$

(49,819

)

 

 

$

(49,819

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity in income (loss) of equity method investments

 

$

6,502

 

 

 

 

 

$

(19,150

)

 

 

 

 

$

(12,648

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Minority interest

 

$

5

 

 

 

 

 

 

 

 

 

 

 

$

5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gains (losses) on investments in equity securities

 

$

1,105

 

 

 

 

 

 

 

 

 

 

 

$

1,105

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

$

913

 

 

 

 

 

 

 

 

 

 

 

$

913

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

$

18,222

 

 

 

 

 

 

 

 

 

 

 

$

18,222

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

$

(1,474

)

 

 

 

 

 

 

 

 

 

 

$

(1,474

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

$

350,875

 

$

 

$

(11,773

)

$

(19,150

)

$

(49,819

)

$

(44,388

)

$

225,745

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Provision for) benefit from income taxes -

 

 

$

(109,558

)

$

 

$

4,274

 

$

6,962

 

$

17,797

 

$

14,093

 

$

(66,432

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

241,317

 

$

 

$

(7,499

)

$

(12,188

)

$

(32,022

)

$

(30,295

)

$

159,313

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.92

 

$

 

$

(0.029

)

$

(0.046

)

$

(0.122

)

$

(0.115

)

$

0.61

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

$

0.90

 

$

(0.024

)

$

(0.027

)

$

(0.044

)

$

(0.115

)

$

(0.109

)

$

0.58

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

262,775

 

 

 

 

 

 

 

 

 

 

 

262,775

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

269,520

 

9,686

 

 

 

 

 

 

 

 

 

279,206

 


(1)  

GAAP As-Reported diluted earnings per share and diluted weighted average shares outstanding reflect the adoption of EITF 04-8. In accordance with the provisions of EITF 04-8, interest and debt fees related to our 1.25% convertible senior notes of $1,886K, net of tax, have been added back to net income and approximately 9,686K shares have been added to diluted weighted average shares for purposes of computing GAAP As-Reported diluted earnings per share.

 

 



 

Genzyme Corporation (GENZ)
Analyst Schedule
(Unaudited, amounts in thousands, except percentage amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

Q3-07

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Q3-06

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

%

 

 

 

 

 

YTD

 

 

 

Q3-06

 

Q4-06

 

Q1-07

 

Q2-07

 

Q3-07

 

B/(W)

 

FY 2005

 

FY 2006

 

9/30/07

 

Total revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renal

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renagel phosphate binder (including Sevelamer)

 

$

134,722

 

$

135,143

 

$

137,384

 

$

144,954

 

$

154,159

 

14

%

$

417,485

 

$

515,119

 

$

436,497

 

Hectorol

 

25,482

 

26,562

 

28,293

 

27,295

 

30,265

 

19

%

34,515

 

93,360

 

85,853

 

Other Renal

 

 

 

 

 

 

 

 

 

 

 

Total Renal product and service revenue

 

160,204

 

161,705

 

165,677

 

172,249

 

184,424

 

15

%

452,000

 

608,479

 

522,350

 

Renal R&D revenue

 

 

 

 

 

 

 

 

 

 

 

Total Renal

 

160,204

 

161,705

 

165,677

 

172,249

 

184,424

 

15

%

452,000

 

608,479

 

522,350

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Therapeutics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cerezyme enzyme

 

252,227

 

261,811

 

263,791

 

282,979

 

286,071

 

13

%

932,322

 

1,007,036

 

832,841

 

Fabrazyme enzyme

 

93,170

 

96,560

 

100,664

 

104,349

 

104,610

 

12

%

305,064

 

359,274

 

309,623

 

Thyrogen hormone

 

22,396

 

24,575

 

26,338

 

29,540

 

26,828

 

20

%

77,740

 

93,687

 

82,706

 

Myozyme enzyme

 

20,402

 

30,254

 

37,919

 

46,745

 

53,568

 

163

%

3,827

 

59,238

 

138,232

 

Other Therapeutics

 

72

 

183

 

167

 

705

 

153

 

113

%

2,292

 

410

 

1,025

 

Total Therapeutics product and service revenue

 

388,267

 

413,383

 

428,879

 

464,318

 

471,230

 

21

%

1,321,245

 

1,519,645

 

1,364,427

 

Therapeutics R&D revenue

 

 

68

 

638

 

431

 

121

 

 

 

789

 

1,068

 

1,190

 

Total Therapeutics

 

388,267

 

413,451

 

429,517

 

464,749

 

471,351

 

21

%

1,322,034

 

1,520,713

 

1,365,617

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Transplant

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Thymoglobulin/Lymphoglobuline

 

37,619

 

39,250

 

39,442

 

41,376

 

41,036

 

9

%

127,739

 

149,541

 

121,854

 

Other Transplant

 

1,622

 

1,997

 

1,655

 

2,048

 

1,845

 

14

%

18,143

 

6,425

 

5,548

 

Total Transplant product and service revenue

 

39,241

 

41,247

 

41,097

 

43,424

 

42,881

 

9

%

145,882

 

155,966

 

127,402

 

Transplant R&D revenue

 

 

 

180

 

 

 

 

 

30

 

 

180

 

Total Transplant

 

39,241

 

41,247

 

41,277

 

43,424

 

42,881

 

9

%

145,912

 

155,966

 

127,582

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Biosurgery

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Synvisc viscosupplementation product and services

 

55,930

 

61,075

 

53,596

 

64,863

 

61,175

 

9

%

218,908

 

233,858

 

179,634

 

Sepra products

 

21,054

 

22,908

 

23,115

 

25,076

 

26,381

 

25

%

68,171

 

85,338

 

74,572

 

Other Biosurgery

 

16,465

 

16,312

 

19,934

 

16,724

 

16,893

 

3

%

65,953

 

67,480

 

53,551

 

Total Biosurgery product and service revenue

 

93,449

 

100,295

 

96,645

 

106,663

 

104,449

 

12

%

353,032

 

386,676

 

307,757

 

Biosurgery R&D revenue

 

 

888

 

1,748

 

1,226

 

1,697

 

 

 

144

 

893

 

4,671

 

Total Biosurgery

 

93,449

 

101,183

 

98,393

 

107,889

 

106,146

 

14

%

353,176

 

387,569

 

312,428

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic Testing

 

61,360

 

61,004

 

66,158

 

73,714

 

73,050

 

19

%

222,328

 

240,857

 

212,922

 

Total Genetics product and service revenue

 

61,360

 

61,004

 

66,158

 

73,714

 

73,050

 

19

%

222,328

 

240,857

 

212,922

 

Genetics R&D revenue

 

 

 

 

 

 

 

 

 

 

 

Total Genetics

 

61,360

 

61,004

 

66,158

 

73,714

 

73,050

 

19

%

222,328

 

240,857

 

212,922

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other product and service revenue

 

62,863

 

70,605

 

75,615

 

67,589

 

74,825

 

19

%

220,195

 

257,904

 

218,029

 

Total Other product and service revenue

 

62,863

 

70,605

 

75,615

 

67,589

 

74,825

 

19

%

220,195

 

257,904

 

218,029

 

Other R&D revenue

 

3,190

 

5,046

 

6,546

 

3,805

 

7,482

 

135

%

19,197

 

15,525

 

17,833

 

Total Other

 

66,053

 

75,651

 

82,161

 

71,394

 

82,307

 

25

%

239,392

 

273,429

 

235,862

 

Total revenues

 

$

808,574

 

$

854,241

 

$

883,183

 

$

933,419

 

$

960,159

 

19

%

$

2,734,842

 

$

3,187,013

 

$

2,776,761

 

 

 



 

Genzyme Corporation (GENZ)
Analyst Schedule
(Unaudited, amounts in thousands, except percentage and per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

Q3-07

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Q3-06

 

 

 

 

 

YTD

 

 

 

Q3-06

 

Q4-06

 

Q1-07

 

Q2-07

 

Q3-07

 

% B/(W)

 

FY 2005

 

FY 2006

 

9/30/07

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total product and service revenue

 

$

805,384

 

$

848,239

 

$

874,071

 

$

927,957

 

$

950,859

 

18

%

$

2,714,682

 

$

3,169,527

 

$

2,752,887

 

Total R&D revenue

 

3,190

 

6,002

 

9,112

 

5,462

 

9,300

 

192

%

20,160

 

17,486

 

23,874

 

Total revenues

 

808,574

 

854,241

 

883,183

 

933,419

 

960,159

 

19

%

2,734,842

 

3,187,013

 

2,776,761

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total product and service gross profit (1,2)

 

620,708

 

649,527

 

671,608

 

710,359

 

706,247

 

14

%

2,082,030

 

2,433,856

 

2,088,214

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SG&A expense (1,3)

 

239,700

 

266,551

 

269,021

 

339,480

 

270,306

 

(13

%)

787,839

 

1,010,400

 

878,807

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

R&D expense (1,4)

 

162,293

 

166,394

 

166,120

 

198,442

 

175,800

 

(8

%)

502,657

 

649,951

 

540,362

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangibles

 

50,542

 

53,238

 

50,017

 

49,465

 

49,819

 

1

%

181,632

 

209,355

 

149,301

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of in-process research and development (5)

 

 

552,900

 

 

 

 

 

 

29,200

 

552,900

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Charge for impaired goodwill (6)

 

219,245

 

 

 

 

 

100

%

 

219,245

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

(47,882

)

(383,554

)

195,562

 

128,434

 

219,622

 

559

%

600,862

 

(190,509

)

543,618

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity in income (loss) of equity method investments (7)

 

4,530

 

5,075

 

5,612

 

5,945

 

(12,648

)

(379

%)

151

 

15,705

 

(1,091

)

Minority interest

 

2,545

 

2,677

 

3,912

 

15

 

5

 

(100

%)

11,952

 

10,418

 

3,932

 

Gain (loss) on investments in equity securities (8)

 

128

 

(1,807

)

12,788

 

143

 

1,105

 

763

%

5,698

 

73,230

 

14,036

 

Other

 

(873

)

(714

)

(525

)

(278

)

913

 

205

%

(1,535

)

(2,045

)

110

 

Investment income

 

16,760

 

16,600

 

16,219

 

17,246

 

18,222

 

9

%

31,429

 

56,001

 

51,687

 

Interest expense

 

(3,772

)

(3,233

)

(4,188

)

(3,621

)

(1,474

)

61

%

(19,638

)

(15,478

)

(9,283

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes (1)

 

(28,564

)

(364,956

)

229,380

 

147,884

 

225,745

 

890

%

628,919

 

(52,678

)

603,009

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Provision for) benefit from income taxes (1)

 

44,530

 

96,722

 

(71,193

)

(64,090

)

(66,432

)

(249

%)

(187,430

)

35,881

 

(201,715

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) (1)

 

$

15,966

 

$

(268,234

)

$

158,187

 

$

83,794

 

$

159,313

 

898

%

$

441,489

 

$

(16,797

)

$

401,294

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share-diluted (1,9,10)

 

$

0.06

 

$

(1.02

)

$

0.57

 

$

0.31

 

$

0.58

 

867

%

$

1.65

 

$

(0.06

)

$

1.45

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding-diluted (1,9,10)

 

278,271

 

262,803

 

279,924

 

280,564

 

279,206

 

0

%

272,224

 

261,124

 

279,898

 

 

 



 

Genzyme Corporation (GENZ)
Analyst Schedule
(Unaudited, amounts in thousands, except percentage amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

YTD

 

 

 

Q3-06

 

Q4-06

 

Q1-07

 

Q2-07

 

Q3-07

 

 

 

FY 2005

 

FY 2006

 

9/30/07

 

Total product and service revenue

 

$

805,384

 

$

848,239

 

$

874,071

 

$

927,957

 

$

950,859

 

 

 

$

2,714,682

 

$

3,169,527

 

$

2,752,887

 

As a % of total product and service revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renagel phosphate binder (including Sevelamer)

 

17

%

16

%

16

%

16

%

16

%

 

 

15

%

16

%

16

%

Hectorol

 

3

%

3

%

3

%

3

%

3

%

 

 

1

%

3

%

3

%

Cerezyme enzyme

 

31

%

31

%

30

%

31

%

30

%

 

 

34

%

32

%

30

%

Fabrazyme enzyme

 

11

%

11

%

12

%

11

%

11

%

 

 

11

%

11

%

11

%

Thyrogen hormone

 

3

%

3

%

3

%

3

%

3

%

 

 

3

%

3

%

3

%

Myozyme enzyme

 

3

%

3

%

4

%

5

%

6

%

 

 

0

%

2

%

5

%

Thymoglobulin/Lymphoglobuline

 

5

%

5

%

5

%

4

%

4

%

 

 

5

%

5

%

4

%

Synvisc viscosupplementation product and services

 

7

%

7

%

6

%

7

%

6

%

 

 

8

%

7

%

7

%

Sepra products

 

3

%

3

%

3

%

3

%

3

%

 

 

3

%

3

%

3

%

Genetics testing

 

8

%

7

%

7

%

8

%

8

%

 

 

8

%

8

%

8

%

Other

 

10

%

11

%

11

%

9

%

10

%

 

 

11

%

10

%

10

%

 

 

100

%

100

%

100

%

100

%

100

%

 

 

100

%

100

%

100

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total product and service gross margin

 

77

%

77

%

77

%

77

%

74

%

 

 

77

%

77

%

76

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

808,574

 

$

854,241

 

$

883,183

 

$

933,419

 

$

960,159

 

 

 

$

2,734,842

 

$

3,187,013

 

$

2,776,761

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SG&A expense as a % of total revenue

 

30

%

31

%

30

%

36

%

28

%

 

 

29

%

32

%

32

%

R&D expense as a % of total revenue

 

20

%

19

%

19

%

21

%

18

%

 

 

18

%

20

%

19

%

Operating income (loss) as a % of total revenue

 

(6

%)

(45

%)

22

%

14

%

23

%

 

 

22

%

(6

%)

20

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Benefit from income taxes as a % of profit (loss) before tax

 

156

%

27

%

31

%

43

%

29

%

 

 

30

%

68

%

33

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheet Information:

 

9/30/06

 

12/31/06

 

3/31/07

 

6/30/07

 

09/30/07

 

 

 

12/31/05

 

12/31/06

 

9/30/07

 

Cash and all marketable securities

 

$

1,675,599

 

$

1,285,604

 

$

1,450,125

 

$

1,497,648

 

$

1,449,548

 

 

 

$

1,089,102

 

$

1,285,604

 

$

1,449,548

 

Other current assets

 

1,319,235

 

1,377,437

 

1,436,061

 

1,503,734

 

1,587,600

 

 

 

1,179,093

 

1,377,437

 

1,587,600

 

Property, plant and equipment, net

 

1,513,632

 

1,610,593

 

1,670,848

 

1,742,651

 

1,850,754

 

 

 

1,320,813

 

1,610,593

 

1,850,754

 

Intangibles, net (6)

 

2,773,653

 

2,790,819

 

2,756,036

 

2,720,421

 

2,689,126

 

 

 

3,078,461

 

2,790,819

 

2,689,126

 

Other assets (11)

 

142,919

 

126,735

 

161,595

 

190,411

 

265,273

 

 

 

211,396

 

126,735

 

265,273

 

Total assets

 

$

7,425,038

 

$

7,191,188

 

$

7,474,665

 

$

7,654,865

 

$

7,842,301

 

 

 

$

6,878,865

 

$

7,191,188

 

$

7,842,301

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

552,091

 

$

651,439

 

$

661,321

 

$

710,377

 

$

693,208

 

 

 

$

550,023

 

$

651,439

 

$

693,208

 

Noncurrent liabilities (11)

 

1,088,114

 

879,038

 

866,893

 

866,068

 

865,322

 

 

 

1,178,975

 

879,038

 

865,322

 

Stockholders’ equity

 

5,784,833

 

5,660,711

 

5,946,451

 

6,078,420

 

6,283,771

 

 

 

5,149,867

 

5,660,711

 

6,283,771

 

Total liabilities and stockholders’ equity

 

$

7,425,038

 

$

7,191,188

 

$

7,474,665

 

$

7,654,865

 

$

7,842,301

 

 

 

$

6,878,865

 

$

7,191,188

 

$

7,842,301

 

 

 



 

Notes:

(1)  

Reflects the adoption of Financial Accounting Standards Board, or FASB, Statement of Financial Accounting Standards No., or FAS, 123R, “Share-Based Payment, an amendment of FASB Statement Nos. 123 and 95,” using the modified prospective basis effective January 1, 2006.  For the periods presented, we recorded pre-tax charges for stock-based compensation expense and related tax benefits of:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

YTD

 

YTD

 

 

 

 

Q3-06

 

Q4-06

 

Q1-07

 

Q2-07

 

Q3-07

 

 

 

 

 

12/31/06

 

9/30/07

 

 

Cost of products and services sold

 

$

(5,663

)

$

(8,537

)

$

(5,896

)

$

(6,865

)

(5,779

)

 

 

 

 

$

(21,430

)

$

(18,540

)

 

Selling, general and administrative expense

 

(24,421

)

(25,262

)

(22,499

)

(35,248

)

(25,091

)

 

 

 

 

(121,822

)

(82,838

)

 

Research and development expense

 

(14,556

)

(14,566

)

(12,312

)

(19,143

)

(13,518

)

 

 

 

 

(65,248

)

(44,973

)

 

Total pre-tax charges for stock compensation expense

 

(44,640

)

(48,365

)

(40,707

)

(61,256

)

(44,388

)

 

 

 

 

(208,500

)

(146,351

)

 

Tax benefit

 

14,312

 

14,094

 

12,432

 

18,703

 

14,093

 

 

 

 

 

66,331

 

45,228

 

 

Stock-based compensation expense, net of tax

 

$

(30,328

)

$

34,271

)

$

(28,275

)

$

(42,553

)

$

(30,295

)

 

 

 

 

$

(142,169

)

$

(101,123

)

 

 

Diluted earnings per share and diluted weighted average shares outstanding for these periods were computed according to the provisions of FAS 123R.

 

 

(2)  

Includes a charge of $(11,773)K recorded in September 2007 to write off four finished lots of our Thymoglobulin inventory, which did not meet our specifications.

 

 

(3)  

Includes a charge of $(64,000)K recorded in June 2007 to settle the litigation related to the consolidation of our former tracking stocks.

 

 

(4)  

Includes a charge of $(25,000)K for an upfront milestone payment paid to Ceregene Inc. in June 2007 for the development and commercialization of certain gene therapy products.

 

 

(5)  

Includes charges for the purchase of in-process research and development of $(552,900)K related to our acquisition of AnorMED Inc. in November 2006, $(7,000)K related to our acquisition of gene therapy assets from Avigen, Inc. in December 2005, $(12,700)K related to our acquisition of Bone Care International, Inc. in July 2005 and $(9,500)K related to our acquisition of Verigen AG in February 2005.

 

 

(6)  

Represents the write off of the goodwill related to our Genetics reporting unit in September 2006 in accordance with FAS 142, “Goodwill and Other Intangible Assets.”

 

 

(7)  

Includes a charge of $(19,150)K related to completion of the first step of the two step acquisition process under which we acquired Bioenvision, Inc. In July 2007, we acquired approximately 22% of the outstanding shares of Bioenvision common stock on an as-converted basis, including all outstanding shares of Bioenvision preferred stock, for approximately $(72,229)K of cash.  Subsequently, in October 2007, following a favorable merger vote by Bioenvision's shareholders, we completed the second step of the acquisition and acquired the remaining outstanding shares of Bioenvision's common stock.  The full purchase accounting for the acquisition of Bioenvision, including the impact of the second step, will be recorded in our consolidated financial statements in October 2007.

 

 

(8)  

Includes pre-tax gains of $69,359K related to the liquidation of our investment in the common stock of Cambridge Antibody Technology Group plc in May and June 2006, and $10,848K related to the sale of our entire investment in the common stock of Therapeutic Human Polyclonals, Inc. in March 2007, which had a zero cost-basis.

 

 

(9)  

All periods, except the three months and the year ended December 31, 2006 include:  (i) the dilutive effect of options, stock purchase rights and warrants to purchase shares of Genzyme Stock and (ii) the potentially dilutive effect of the assumed conversion of our 1.25% convertible senior notes.

 

 

 

For the three months and the year ended December 31, 2006, excludes:  (i) the dilutive effect of options, stock purchase rights and warrants to purchase shares of Genzyme Stock and (ii) the potentially dilutive effect of the assumed conversion of our convertible senior notes because the effect would be anti-dilutive due to our net loss for both of those periods.

 

 

(10)  

All periods, except the three months and the year ended December 31, 2006, reflect the adoption of Emerging Issues Task Force Issue No. 04-8, "The Effect of Contingently Convertible Debt on Diluted Earnings Per Share," or EITF 04-8.  As a result of the adoption of EITF 04-8, interest and debt fees, net of tax, related to our $690,000K in principal of 1.25% convertible senior notes, which were issued in December 2003, have been added back to net income and the 9,686K shares issuable upon conversion of these notes are now included in diluted weighted average shares outstanding for purposes of computing diluted earnings per share, unless the effect would be anti-dilutive.

 

 

(11)  

Other assets includes net deferred tax assets of $54,401K as of June 30, 2007 and $78,243K as of September 30, 2007, as compared to net deferred tax liabilities reported as a component of noncurrent liabilities in all other periods presented.

 

 



 

GENZYME CORPORATION (GENZ)

Consolidated Statements of Operations

(Unaudited, amounts in thousands, except per share amounts)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

Total revenues

 

$

960,159

 

$

808,574

 

$

2,776,761

 

$

2,332,772

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of products and services sold (1,2)

 

244,612

 

184,676

 

664,673

 

536,959

 

Selling, general and administrative (1,3)

 

270,306

 

239,700

 

878,807

 

743,849

 

Research and development (1,4)

 

175,800

 

162,293

 

540,362

 

483,557

 

Amortization of intangibles

 

49,819

 

50,542

 

149,301

 

156,117

 

Charge for impaired goodwill (5)

 

 

219,245

 

 

219,245

 

Total operating costs and expenses

 

740,537

 

856,456

 

2,233,143

 

2,139,727

 

Operating income (loss)

 

219,622

 

(47,882

)

543,618

 

193,045

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Equity in income (loss of equity method investments (6)

 

(12,648

)

4,530

 

(1,091

)

10,630

 

Minority interest

 

5

 

2,545

 

3,932

 

7,741

 

Gain on investments in equity securities (7)

 

1,105

 

128

 

14,036

 

75,037

 

Other

 

913

 

(873

)

110

 

(1,331

)

Investment income

 

18,222

 

16,760

 

51,687

 

39,401

 

Interest expense

 

(1,474

)

(3,772

)

(9,283

)

(12,245

)

Total other income (expenses

 

6,123

 

19,318

 

59,391

 

119,233

 

Income (loss) before income taxes (1)

 

225,745

 

(28,564

)

603,009

 

312,278

 

(Provision for) benefit from income taxes (1)

 

(66,432

)

44,530

 

(201,715

)

(60,841

Net income (1)

 

$

159,313

 

$

15,966

 

$

401,294

 

$

251,437

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.61

 

$

0.06

 

$

1.52

 

$

0.96

 

 

 

 

 

 

 

 

 

 

 

Diluted (1,8)

 

$

0.58

 

$

0.06

 

$

1.45

 

$

0.93

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

262,775

 

261,541

 

263,387

 

260,565

 

 

 

 

 

 

 

 

 

 

 

Diluted (1,8)

 

279,206

 

278,271

 

279,898

 

277,130

 


(1)  

In accordance with the provisions of Financial Accounting Standards Board, or FASB, Statement of Financial Accounting Standards No., or FAS, 123R, “Share-Based Payment, an amendment of FASB Statement Nos. 123 and 95,” we recorded pre-tax charges for stock-based compensation expense and related tax benefits of:

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

 

September 30,

 

September 30,

 

 

 

 

2007

 

2006

 

2007

 

2006

 

       

Cost of products and services sold

 

$

(5,779

)

$

(5,663

)

$

(18,540

)

$

(12,893

)

 

Selling, general and administrative expense

 

(25,091

)

(24,421

)

(82,838

)

(96,560

)

 

Research and development expense

 

(13,518

)

(14,556

)

(44,973

)

(50,682

)

 

Total pre-tax charges for stock-based compensation expense

 

(44,388

)

(44,640

)

(146,351

)

(160,135

)

 

Tax benefit

 

14,093

 

14,312

 

45,228

 

52,237

 

 

Stock-based compensation expense, net of tax

 

$

(30,295

)

$

(30,328

)

$

(101,123

)

$

(107,898

)

 

 

Diluted earnings per share and diluted weighted average shares outstanding for the three and nine months ended September 30, 2007 and 2006 were computed according to the provisions of FAS 123R.

 

 

(2)  

Includes a charge of $(11,773)K recorded in September 2007 to write off four finished lots of our Thymoglobulin inventory, which did not meet our specifications.

 

 

(3)  

Includes a charge of $(64,000)K recorded in June 2007 to settle the litigation related to the consolidation of our former tracking stocks.

 

 

(4)  

Includes a charge of $(25,000)K for an upfront milestone payment paid to Ceregene Inc. in June 2007 for the development and commercialization of certain gene therapy products.

 

 

(5)  

Represents the write off of the goodwill related to our Genetics reporting unit in September 2006 in accordance with FAS 142, “Goodwill and Other Intangible Assets.”

 

 



 

(6)  

Includes a charge of $(19,150)K related to completion of the first step of the two step acquisition process under which we acquired Bioenvision, Inc. In July 2007, we acquired approximately 22% of the outstanding shares of Bioenvision common stock on an as-converted basis, including all outstanding shares of Bioenvision preferred stock, for approximately $72,229K of cash.  Subsequently, in October 2007, following a favorable merger vote by Bioenvision’s shareholders, we completed the second step of the acquisition and, effective October 23, 2007, acquired the remaining outstanding shares of Bioenvision’s common stock.  The full purchase accounting for the acquisition of Bioenvision, including the impact of the second step, will be recorded in our consolidated financial statements for October 2007.

 

 

(7)  

For the nine months ended September 30, 2007, includes a pre-tax gain of $10,848K recorded on the sale of our entire investment in the common stock of Therapeutic Human Polyclonals Inc. in March 2007, which had a zero cost basis.  For the nine months ended September 30, 2006, includes pre-tax gains of $69,359K related to the liquidation of our investment in the common stock of Cambridge Antibody Technology Group plc in May and June 2006.

 

 

(8)  

Reflects the retroactive application of the adoption of Emerging Issues Task Force Issue No. 04-8, “The Effect of Contingently Convertible Debt on Diluted Earnings Per Share,” or EITF 04-8.  As a result of the adoption of EITF 04-8, the 9,686K shares issuable upon conversion of our $690,000K in principal of 1.25% convertible senior notes, which were issued in December 2003, are now included in diluted weighted average shares outstanding for purposes of computing diluted earnings per share, unless the effect would be anti-dilutive.  In accordance with EITF 04-8, interest and debt fees related to these notes of $1.9 million, net of tax, for the three months ended September 30, 2007 and 2006, and $5.7 million, net of tax, for the nine months ended September 30, 2007 and 2006, have been added back to net income and 9,686K shares have been added to diluted weighted average shares outstanding for each of those periods for purposes of computing diluted earnings per share.

 

GENZYME CORPORATION (GENZ)

 

 

 

September 30,

 

December 31,

 

Condensed Consolidated Balance Sheets

 

2007

 

2006

 

(Unaudited, amounts in thousands)

 

 

 

 

 

Cash and all marketable securities

 

$

1,449,548

 

$

1,285,604

 

Other current assets

 

1,587,600

 

1,377,437

 

Property, plant and equipment, net

 

1,850,754

 

1,610,593

 

Intangibles, net

 

2,689,126

 

2,790,819

 

Other assets (1,2)

 

265,273

 

126,735

 

Total assets

 

$

7,842,301

 

$

7,191,188

 

 

 

 

 

 

 

Current liabilities

 

$

693,208

 

$

651,439

 

Noncurrent liabilities (1)

 

865,322

 

879,038

 

Stockholders’ equity

 

6,283,771

 

5,660,711

 

Total liabilities and stockholders’ equity

 

$

7,842,301

 

$

7,191,188

 


(1)  

Other assets as of September 30, 2007 includes $78,243K of net deferred tax assets, as compared to net deferred tax liabilities of $10,909K as of December 31, 2006, which were included as a component of noncurrent liabilities.

 

 

(2)  

Includes $72,229K related to the completion of the first step of our two step acquisition of Bioenvision, including $25,200K for the acquisition of all of the outstanding Bioenvision preferred stock and $47,029K for the acquisition of a portion of the outstanding shares of Bioenvision common stock.  Effective October 23, 2007, following a favorable merger vote by Bioenvision’s shareholders, we completed the second step of the acquisition and acquired the remaining outstanding shares of Bioenvision common stock.  The full purchase accounting for our acquisition of Bioenvision, including the impact of the second step, will be recorded in our consolidated financial statements for October 2007.

 

 


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