EX-99.1 2 a07-20120_1ex99d1.htm EX-99.1

 

Exhibit 99.1

For Immediate Release

 

Media Contact:

 

 

Investor Contact:

 

July 25, 2007

 

Bo Piela

 

Sally Curley

 

 

(617) 768-6579

 

(617) 768-6140

 

Genzyme Reports Significant Earnings Growth in Second Quarter

------------------------------------------

Expects Compound Earnings Growth of 20 Percent over Next Five Years

CAMBRIDGE, Mass. — Genzyme Corporation (Nasdaq: GENZ) reported today that strong revenue growth and solid operating leverage drove a significant increase in second-quarter non-GAAP profits, continuing the momentum of the past several quarters. Revenue rose 18 percent to $933.4 million from $793.4 million in the same period a year ago, driven once again by growth in most product areas.

GAAP net income rose to $139.9 million, or $0.51 per diluted share, compared with $134.5 million, or $0.49 per diluted share, in the quarter a year ago.

Non-GAAP net income grew 32 percent to $238.7 million from $181.2 million in the same period last year. Non-GAAP earnings rose 30 percent to $0.88 per diluted share from $0.68. Non-GAAP figures for this year’s second quarter exclude pre-tax stock-compensation expenses of $71.8 million, amortization of $49.5 million, a $25 million milestone payment to Ceregene Inc., and the effect of contingent convertible debt.

Genzyme expects to exceed its 2007 non-GAAP earnings guidance of $3.20-$3.30 per diluted share, given its strong results in the first half of the year. The company now expects non-GAAP earnings of $3.35-$3.40 per diluted share.

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Based on its strong and consistent performance, the potential of its deep product portfolio, and the leverage from its global infrastructure, Genzyme anticipates that non-GAAP earnings will grow at a compound average of 20 percent annually from 2006 through 2011.

“We are confident about the current strength of the company and have a bullish view of our future,” said Genzyme’s Chairman and Chief Executive Officer, Henri A. Termeer. “We remain focused on our goal of sustaining a 20 percent earnings growth rate. We evaluate every decision we make about internal programs and acquisitions in the context of this goal.”

During the second quarter, Genzyme generated approximately $290 million in cash from operations and increased its cash position to approximately $1.5 billion. The company has begun using a portion of its operating cash flow to repurchase up to 20 million of its outstanding common shares over the next three years to reduce the dilutive effect of its equity compensation programs. In the second quarter, the company repurchased approximately 1 million shares.

Genzyme has reported pivotal trial results this year for many late-stage development programs. These results provide greater clarity and certainty about the promise of a number of potential new products that the company expects will contribute to its growth over the longer term. Based on the results of these studies, Genzyme anticipates that during the next six to twelve months it will do the following:

—Apply for approval to market Mozobil (plerixafor), an innovative product intended to facilitate and improve the outcome of stem-cell transplantation procedures. In the pivotal trial of Mozobil involving patients with non-Hodgkin’s lymphoma, the product showed a treatment effect that was three times greater than the current standard of care. In the first half of next year, Genzyme intends to apply for U.S. and European approval to market Mozobil for a lymphoma indication. The company will also seek a multiple myeloma indication for Mozobil

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if the soon-to-be released results from a second phase 3 trial are also favorable. Genzyme’s global presence in the transplant field will provide an excellent platform for the anticipated introduction of Mozobil.

—Launch Renvela® (sevelamer carbonate) in the United States. Renvela is a second-generation, buffered form of Renagel® (sevelamer hydrochloride) that will enable Genzyme to expand the market for its phosphate binder by reaching patients with chronic kidney disease who have not progressed to dialysis. The FDA is currently reviewing Genzyme’s application for Renvela’s use by dialysis patients. The company expects to subsequently pursue a chronic kidney disease indication and to file for approval of a powder form of Renvela that may make it easier for patients to comply with their prescribed treatment program.

—Gain approval for Campath® (alemtuzumab) as a first-line treatment for B-cell chronic lymphocytic leukemia (B-CLL). The product is currently indicated for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Genzyme has filed to expand Campath’s U.S. and European labeling to include first-line treatment, which would significantly increase the number of patients eligible to receive the product. FDA action is expected in the third quarter.

Seek U.S. approval for the use of Clolar® (clofarabine for injection) as a first-line treatment for adult patients with acute myeloid leukemia (AML). Clolar is currently indicated for the treatment of acute lympblastic leukemia in relapsed and refractory pediatric patients. Genzyme is conducting two trials of Clolar involving adult patients with AML and expects to pursue an expanded U.S. indication next year.

—Launch Synvisc-One, an investigational combined-dose regimen of Synvisc® (hylan G-F 20) provided in a single injection. Genzyme is confident that a viscosupplementation product that can be delivered through a single knee injection will simplify osteoarthritis pain management, reduce the overall cost of therapy and offer a treatment option that may expand the benefits of viscosupplementation to a broader number of patients. The company has submitted U.S. and European applications for Synvisc-One, and action on both is expected this year.

—Apply for CE Mark approval of 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. The pivotal trial of hylastan showed that the product reduced knee pain in a significant and clinically meaningful way, and Genzyme believes that this result will support a CE mark approval in Europe. The pivotal study of hylastan did not meet its primary endpoint of showing that the product can provide superior pain relief to steroids.

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Therapeutics

Sales of Genzyme’s four treatments for lysosomal storage disorders showed continued strength in the second quarter, driven by the growing number of patients receiving therapy. Sales of Myozyme® (alglucosidase alfa) rose to $46.7 million, compared with $6.5 million in the same period a year ago following product launch. Last month, Genzyme launched Myozyme in Japan, and the company is preparing for approval in Brazil, another key market. Genzyme is pursuing FDA approval of a larger scale manufacturing process to supply Myozyme for the U.S. market, and an agency decision is now expected in the first half of next year. Production at this larger scale is already approved in 28 countries. The company is accelerating efforts to optimize product supply for the U.S. market until the FDA approves the larger-scale process. These efforts include temporarily transitioning some patients to a clinical access program through which they 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 available in the first part of next year for submission to regulatory authorities.

Sales of Fabrazyme® (agalsidase beta) increased 17 percent to $104.3 million, compared with $89.0 million in the same quarter last year. Sales of Cerezyme® (imiglucerase for injection) grew 11 percent to $283.0 million, compared with $254.0 million in the second quarter a year ago. Sales of Aldurazyme® (laronidase) grew 24 percent to $29.1 million, compared with $23.5 million in last year’s second quarter. Aldurazyme is marketed through a joint venture with BioMarin Pharmaceutical Inc.

Genzyme expects that it will receive approval to market Elaprase (idursulfase) in Japan by the end of this year. Elaprase is an enzyme replacement therapy for the

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treatment of the lysosomal storage disorder MPS II, also known as Hunter syndrome. Genzyme is commercializing Elaprase in Asia under an agreement with Shire plc.

Genzyme has completed enrollment in the open-label Phase 2 trial of the small molecule Genz-112638, a novel oral therapy being developed for the treatment of Gaucher disease. Based on positive results seen in the trial to date, the company intends to meet with regulatory agencies in the coming weeks to discuss an expedited development strategy. Initial observations for the first five patients were presented at Genzyme’s Analyst Day meeting in May and suggest that Genz-112638 may produce a rapid and meaningful impact on important clinical endpoints including reductions in spleen and liver volume, and an increase in platelet counts and hemoglobin concentration. Results for the sixth patient enrolled in the study have now been analyzed and are consistent with observations for the first five patients.

Sales of Thyrogen® (thyrotropin alfa for injection) grew 25 percent in the second quarter to $29.5 million, compared with $23.7 million in the period a year ago. Genzyme expects U.S. approval for Thyrogen’s use in thyroid cancer ablation procedures this year. This indication is included in the product’s labeling in the European Union and a number of other major markets. To potentially further broaden the use of thyrotropin alfa, Genzyme has initiated a phase 2 study of a novel formulation of recombinant TSH that will evaluate the product’s ability to benefit patients suffering from multinodular goiter.

Renal

Within the Renal business, sales of Renagel® (sevelamer hydrochloride) rose 14 percent to $145.0 million, up from $126.6 million in the second quarter a year ago. Renagel continues to gain market share based on its demonstrated clinical and

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economic benefits. Results from the Dialysis Clinical Outcomes Revisited (D-COR) study of Renagel have been accepted for publication in a major nephrology journal this fall. The study compared mortality and morbidity outcomes for patients on Renagel and patients receiving calcium-based phosphate binders.

Sales of Hectorol® (doxercalciferol) rose 22 percent to $27.3 million from $22.4 million a year ago. Hectorol is currently approved in the United States, and Genzyme is working to make the product available internationally.

Genzyme recently announced that the first of two phase 3 studies of tolevamer for Clostridium difficile-associated diarrhea did not meet its primary endpoint. This outcome changes the company’s expectation about the potential for commercializing tolevamer in the near future. Results from a second phase 3 study will be available later this year and will help Genzyme determine what contribution tolevamer might be able to make in addressing this serious unmet medical need.

Transplant

Sales of Thymoglobulin® (anti-thymocyte globulin, rabbit) and Lymphoglobuline® (anti-thymocyte globulin, equine) were $41.4 million in the second quarter, a 4 percent increase from $39.8 million in last year’s second quarter.

Biosurgery

Within the Biosurgery unit, second-quarter sales of Synvisc were $64.9 million, 2 percent greater than sales of $63.6 million in last year’s second quarter. Genzyme is focused on changing the clinical and economic picture in the competitive market for viscosupplementation products with the launch of the single-injection regimen, Synvisc-One.

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Sales of Sepra® products rose 14 percent to $25.1 million in the second quarter, up from $22.0 million in last year’s second quarter. This increase is relatively consistent with previous quarters and reflects the growing use of Seprafilm® adhesion barrier in larger markets such as gynecologic surgery. Genzyme has increased the size of its U.S. Sepra sales force to drive the future growth of this product.

Genetics

Genetics revenue increased by 21 percent in the second quarter, as the business continues to gain momentum, spurred by increasing market share, growth in its clinical trial business, and broader recognition throughout the health care industry of the value of diagnostics in improving outcomes. Revenue was a record $73.7 million compared with $61.0 million in the same period a year ago.

Other

Other revenue increased 8 percent in the second quarter to $71.4 million, compared with $66.4 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 significantly again this quarter, growing 27 percent to $17.4 million from $13.7 million in the second quarter a year ago. Oncology revenue includes sales of Clolar and profits and royalties for Campath.

Genzyme announced in May an agreement to acquire Bioenvision Inc. for approximately $345 million. The transaction process is moving forward as specified in the merger agreement. Bioenvision is preparing a proxy statement for its shareholders detailing the rationale for the merger and other material disclosures. A merger vote by Bioenvision shareholders is expected before the end of the year.

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Genzyme and partner Bayer Schering Pharma AG, Germany, are moving ahead with a major program to complete the development of alemtuzumab for patients with multiple sclerosis. The companies have had extensive conversations with regulatory authorities in the United States and Europe and are preparing to conduct two phase 3 clinical trials, one involving previously untreated patients and one involving patients receiving an approved therapy whose disease has progressed. The former trial is expected to begin this quarter. Three-year data from the phase 2 clinical trial of alemtuzumab for relapsing-remitting multiple sclerosis are expected to be available later this year.

Expenses

Second-quarter operating expenses increased 10 percent compared with the same quarter last year, while revenue grew 18 percent, underscoring the leverage Genzyme is gaining from its global commercial infrastructure. Non-GAAP selling, general and administrative expenses were $240.2 million compared to $220.4 million in the second quarter last year. Non-GAAP SG&A spending represented 26 percent of revenue in the quarter, down from 28 percent in the second quarter last year.

Non-GAAP research and development spending rose to $154.3 million in the second quarter, up from $138.6 million in last year’s second quarter, reflecting increased spending on late-stage programs. Non-GAAP R&D spending represented 17 percent of revenue, consistent with last year’s second quarter.

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

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than 9,500 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 2007; its expectation of a 20% compound average non-GAAP earnings growth rate through 2001; its product development plans and timelines and regulatory filing and action estimates, including for Mozobil in multiple myeloma and non-Hodgkin’s lymphoma, Renvela, Synvisc-One, Hylastan, Elaprase, Genz-112638, Thyrogen in thyroid ablation, TSH in multinodular goiter, Clolar in adult AML, Campath as first line treatment in B-CLL, alemtuzumab for MS, and Myozyme’s post-marketing study in late onset patients; its planned merger with Bioenvision, including the timing of Bioenvision’s proxy solicitation process and shareholder meeting; its estimated timeline for receipt of FDA approval for a larger-scale Myozyme manufacturing process and its Myozyme supply optimization efforts; and its expected drivers of future growth. 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 complete preclinical and clinical development of its products and services; 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; Genzyme’s

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success in optimizing U.S. supply of Myozyme; 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 March 31, 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 July 25, 2007 and Genzyme undertakes no obligation to update or revise the statements.

Genzyme®, Myozyme®, Fabrazyme®, Cerezyme®, Thyrogen®, Renagel®, Hectorol®, Thymoglobulin®, Lymphoglobuline®, Synvisc®, WelChol®, Sepra®, Seprafilm®, Campath® and Clolar® are registered trademarks and Mozobil™, Renvela™, Elaprase™, Hylastan™ are trademarks of Genzyme Corporation or its subsidiaries. All rights reserved.

# # #

Conference Call Information

Genzyme Corporation will host a conference call today at 11:00 a.m. Eastern Time to discuss second-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 August 1, 2007.

Upcoming Events

Genzyme Corporation will host a conference call October 24 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 October 31, 2007.

# # #

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.

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GENZYME CORPORATION

RECONCILIATION OF GAAP TO NON-GAAP EARNINGS

For the Three Months Ended June 30, 2007

(Amounts in thousands, except per share data)

 

 

 

Dilution

 

 

 

 

 

 

 

 

 

 

 

 

 

Due to

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

Milestone

 

 

 

FAS 123R

 

GAAP

 

 

 

NON-GAAP

 

Equivalents

 

Payment

 

Amortization

 

Expense

 

As Reported

 

Income Statement Classification:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

933,419

 

 

 

 

 

 

 

 

 

$

933,419

 

Cost of products and services sold

 

$

(210,733

)

 

 

 

 

 

 

$

(6,879

)

$

(217,612

)

Selling, general and administrative

 

$

(240,232

)

 

 

 

 

 

 

$

(43,018

)

$

(283,250

)

Research and development

 

$

(154,299

)

 

 

$

(25,000

)

 

 

$

(21,862

)

$

(201,161

)

Amortization of intangibles

 

$

 

 

 

 

 

$

(49,465

)

 

 

$

(49,465

)

Equity in income (loss) of equity method investments

 

$

5,945

 

 

 

 

 

 

 

 

 

$

5,945

 

Minority interest

 

$

15

 

 

 

 

 

 

 

 

 

$

15

 

Gains (losses) on investments in equity securities

 

$

143

 

 

 

 

 

 

 

 

 

$

143

 

Other

 

$

(278

)

 

 

 

 

 

 

 

 

$

(278

)

Investment income

 

$

17,246

 

 

 

 

 

 

 

 

 

$

17,246

 

Interest expense

 

$

(3,621

)

 

 

 

 

 

 

 

 

$

(3,621

)

Summary:

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

$

347,605

 

$

 

$

(25,000

)

$

(49,465

)

$

(71,759

)

$

201,381

 

(Provision for) benefit from income taxes

 

$

(108,940

)

$

 

$

9,072

 

$

17,654

 

$

20,782

 

$

(61,432

)

Net income (loss)

 

$

238,665

 

$

 

$

(15,928

)

$

(31,811

)

$

(50,977

)

$

139,949

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.90

 

$

 

$

(0.060

)

$

(0.121

)

$

(0.193

)

$

0.53

 

Diluted(1)

 

$

0.88

 

$

(0.022

)

$

(0.057

)

$

(0.113

)

$

(0.182

)

$

0.51

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

263,911

 

 

 

 

 

 

 

 

 

263,911

 

Diluted(1)

 

270,878

 

9,686

 

 

 

 

 

 

 

280,564

 


(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.

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GENZYME CORPORATION (GENZ)

Consolidated Statements of Operations

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

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

Total revenues

 

$

933,419

 

$

793,356

 

$

1,816,602

 

$

1,524,198

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of products and services sold (1)

 

217,612

 

185,333

 

420,075

 

352,283

 

Selling, general and administrative (1)

 

283,250

 

273,480

 

552,271

 

504,149

 

Research and development (1,2)

 

201,161

 

168,941

 

367,281

 

321,264

 

Amortization of intangibles

 

49,465

 

52,883

 

99,482

 

105,575

 

Total operating costs and expenses

 

751,488

 

680,637

 

1,439,109

 

1,283,271

 

Operating income

 

181,931

 

112,719

 

377,493

 

240,927

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Equity in income of equity method investments

 

5,945

 

3,854

 

11,557

 

6,100

 

Minority interest

 

15

 

2,750

 

3,927

 

5,196

 

Gain on investments in equity securities (3)

 

143

 

66,967

 

12,931

 

74,909

 

Other

 

(278

)

(319

)

(803

)

(458

)

Investment income

 

17,246

 

12,563

 

33,465

 

22,641

 

Interest expense

 

(3,621

)

(4,035

)

(7,809

)

(8,473

)

Total other income (expenses)

 

19,450

 

81,780

 

53,268

 

99,915

 

Income before income taxes(1)

 

201,381

 

194,499

 

430,761

 

340,842

 

Provision for income taxes(1)

 

(61,432

)

(60,002

)

(132,625

)

(105,371

)

Net income(1)

 

$

139,949

 

$

134,497

 

$

298,136

 

$

235,471

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.53

 

$

0.52

 

$

1.13

 

$

0.91

 

Diluted(1,4)

 

$

0.51

 

$

0.49

 

$

1.08

 

$

0.86

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

263,911

 

260,444

 

263,693

 

260,076

 

Diluted(1,4)

 

280,564

 

276,312

 

280,244

 

276,560

 


(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
June 30,

 

Six Months Ended
June 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

Cost of products and services sold

 

$

(6,879

)

$

(4,927

)

$

(12,775

)

$

(7,230

)

Selling, general and administrative expense

 

(43,018

)

(52,692

)

(65,517

)

(72,139

)

Research and development expense

 

(21,862

)

(25,269

)

(34,174

)

(36,126

)

Total pre-tax charges for stock-based compensation expense

 

(71,759

)

(82,888

)

(112,466

)

(115,495

)

Tax benefit

 

20,782

 

27,577

 

33,214

 

37,925

 

Stock-based compensation expense, net of tax

 

$

(50,977

)

$

(55,311

)

$

(79,252

)

$

(77,570

)

 

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

(2)             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.

(3)             For the six months ended June 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 three and six months ended June 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.

(4)             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 June 30, 2007 and 2006 and $3.8 million, net of tax, for the six months ended June 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.

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GENZYME CORPORATION (GENZ)

Condensed Consolidated Balance Sheets

(Unaudited, amounts in thousands)

 

 

June 30,

 

December 31,

 

 

 

2007

 

2006

 

Cash and all marketable securities

 

$

1,500,148

 

$

1,285,604

 

Other current assets

 

1,504,093

 

1,377,437

 

Property, plant and equipment, net

 

1,742,651

 

1,610,593

 

Intangibles, net

 

2,717,921

 

2,790,819

 

Other assets

 

192,490

 

126,735

 

Total assets

 

$

7,657,303

 

$

7,191,188

 

 

 

 

 

 

 

Current liabilities

 

$

645,798

 

$

651,439

 

Noncurrent liabilities

 

866,068

 

879,038

 

Stockholders’ equity

 

6,145,437

 

5,660,711

 

Total liabilities and stockholders’ equity

 

$

7,657,303

 

$

7,191,188

 

 

13




 

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

 

 

 

 

 

 

 

 

 

 

 

 

Q2-07

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Q2-06

 

 

 

 

 

YTD

 

 

 

Q2-06

 

Q3-06

 

Q4-06

 

Q1-07

 

Q2-07

 

% B/(W)

 

FY 2005

 

FY 2006

 

6/30/07

 

Total revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renal

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renagel phosphate binder (including Sevelamer)

 

$

126,599

 

$

134,722

 

$

135,143

 

$

137,384

 

$

144,954

 

14

%

$

417,485

 

$

515,119

 

$

282,338

 

Hectorol

 

22,412

 

25,482

 

26,562

 

28,293

 

27,295

 

22

%

34,515

 

93,360

 

55,588

 

Other Renal

 

(31

)

 

 

 

 

100

%

 

 

 

Total Renal product and service revenue

 

148,980

 

160,204

 

161,705

 

165,677

 

172,249

 

16

%

452,000

 

608,479

 

337,926

 

Renal R&D revenue

 

 

 

 

 

 

 

 

 

 

 

Total Renal

 

148,980

 

160,204

 

161,705

 

165,677

 

172,249

 

16

%

452,000

 

608,479

 

337,926

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Therapeutics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cerezyme enzyme

 

253,989

 

252,227

 

261,811

 

263,791

 

282,979

 

11

%

932,322

 

1,007,036

 

546,770

 

Fabrazyme enzyme

 

89,041

 

93,170

 

96,560

 

100,664

 

104,349

 

17

%

305,064

 

359,274

 

205,013

 

Thyrogen hormone

 

23,723

 

22,396

 

24,575

 

26,338

 

29,540

 

25

%

77,740

 

93,687

 

55,878

 

Myozyme enzyme

 

6,531

 

20,402

 

30,254

 

37,919

 

46,745

 

>100

%

3,827

 

59,238

 

84,664

 

Other Therapeutics

 

78

 

72

 

183

 

167

 

705

 

>100

%

2,292

 

410

 

872

 

Total Therapeutics product and service revenue

 

373,362

 

388,267

 

413,383

 

428,879

 

464,318

 

24

%

1,321,245

 

1,519,645

 

893,197

 

Therapeutics R&D revenue

 

 

 

68

 

638

 

431

 

 

 

789

 

1,068

 

1,069

 

Total Therapeutics

 

373,362

 

388,267

 

413,451

 

429,517

 

464,749

 

24

%

1,322,034

 

1,520,713

 

894,266

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Transplant

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Thymoglobulin/Lymphoglobuline

 

39,812

 

37,619

 

39,250

 

39,442

 

41,376

 

4

%

127,739

 

149,541

 

80,818

 

Other Transplant

 

1,400

 

1,622

 

1,997

 

1,655

 

2,048

 

46

%

18,143

 

6,425

 

3,703

 

Total Transplant product and service revenue

 

41,212

 

39,241

 

41,247

 

41,097

 

43,424

 

5

%

145,882

 

155,966

 

84,521

 

Transplant R&D revenue

 

 

 

 

180

 

 

 

 

30

 

 

180

 

Total Transplant

 

41,212

 

39,241

 

41,247

 

41,277

 

43,424

 

5

%

145,912

 

155,966

 

84,701

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Biosurgery

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Synvisc viscosupplementation product and services

 

63,590

 

55,930

 

61,075

 

53,596

 

64,863

 

2

%

218,908

 

233,858

 

118,459

 

Sepra products

 

21,961

 

21,054

 

22,908

 

23,115

 

25,076

 

14

%

68,171

 

85,338

 

48,191

 

Other Biosurgery

 

16,849

 

16,465

 

16,312

 

19,934

 

16,724

 

(1

)%

65,953

 

67,480

 

36,658

 

Total Biosurgery product and service revenue

 

102,400

 

93,449

 

100,295

 

96,645

 

106,663

 

4

%

353,032

 

386,676

 

203,308

 

Biosurgery R&D revenue

 

1

 

 

888

 

1,748

 

1,226

 

>100

%

144

 

893

 

2,974

 

Total Biosurgery

 

102,401

 

93,449

 

101,183

 

98,393

 

107,889

 

5

%

353,176

 

387,569

 

206,282

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic Testing

 

61,041

 

61,360

 

61,004

 

66,158

 

73,714

 

21

%

222,328

 

240,857

 

139,872

 

Total Genetics product and service revenue

 

61,041

 

61,360

 

61,004

 

66,158

 

73,714

 

21

%

222,328

 

240,857

 

139,872

 

Genetics R&D revenue

 

 

 

 

 

 

 

 

 

 

 

Total Genetics

 

61,041

 

61,360

 

61,004

 

66,158

 

73,714

 

21

%

222,328

 

240,857

 

139,872

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other product and service revenue

 

62,752

 

62,863

 

70,605

 

75,615

 

67,589

 

8

%

220,195

 

257,904

 

143,204

 

Total Other product and service revenue

 

62,752

 

62,863

 

70,605

 

75,615

 

67,589

 

8

%

220,195

 

257,904

 

143,204

 

Other R&D revenue

 

3,608

 

3,190

 

5,046

 

6,546

 

3,805

 

5

%

19,197

 

15,525

 

10,351

 

Total Other

 

66,360

 

66,053

 

75,651

 

82,161

 

71,394

 

8

%

239,392

 

273,429

 

153,555

 

Total revenues

 

$

793,356

 

$

808,574

 

$

854,241

 

$

883,183

 

$

933,419

 

18

%

$

2,734,842

 

$

3,187,013

 

$

1,816,602

 

 

14




 

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

 

 

 

 

 

 

 

 

 

 

 

 

Q2-07

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Q2-06

 

 

 

 

 

YTD

 

 

 

Q2-06

 

Q3-06

 

Q4-06

 

Q1-07

 

Q2-07

 

% B/(W)

 

FY 2005

 

FY 2006

 

6/30/07

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total product and service revenue

 

$

789,747

 

$

805,384

 

$

848,239

 

$

874,071

 

$

927,957

 

18

%

$

2,714,682

 

$

3,169,527

 

$

1,802,028

 

Total R&D revenue

 

3,609

 

3,190

 

6,002

 

9,112

 

5,462

 

51

%

20,160

 

17,486

 

14,574

 

Total revenues

 

793,356

 

808,574

 

854,241

 

883,183

 

933,419

 

18

%

2,734,842

 

3,187,013

 

1,816,602

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total product and service gross profit(1)

 

604,414

 

620,708

 

649,527

 

671,608

 

710,345

 

18

%

2,082,030

 

2,433,856

 

1,381,953

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SG&A expense(1)

 

273,480

 

239,700

 

266,551

 

269,021

 

283,250

 

(4

)%

787,839

 

1,010,400

 

552,271

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

R&D expense(1,2)

 

168,941

 

162,293

 

166,394

 

166,120

 

201,161

 

(19

)%

502,657

 

649,951

 

367,281

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangibles

 

52,883

 

50,542

 

53,238

 

50,017

 

49,465

 

6

%

181,632

 

209,355

 

99,482

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of in-process research and development(3)

 

 

 

552,900

 

 

 

 

 

29,200

 

552,900

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Charge for impaired goodwill(4)

 

 

219,245

 

 

 

 

 

 

 

219,245

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

112,719

 

(47,882

)

(383,554

)

195,562

 

181,931

 

61

%

600,862

 

(190,509

)

377,493

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity in income of equity method investments

 

3,854

 

4,530

 

5,075

 

5,612

 

5,945

 

54

%

151

 

15,705

 

11,557

 

Minority interest

 

2,750

 

2,545

 

2,677

 

3,912

 

15

 

(99

)%

11,952

 

10,418

 

3,927

 

Gain (loss) on investments in equity securities(5)

 

66,967

 

128

 

(1,807

)

12,788

 

143

 

(100

)%

5,698

 

73,230

 

12,931

 

Other

 

(319

)

(873

)

(714

)

(525

)

(278

)

13

%

(1,535

)

(2,045

)

(803

)

Investment income

 

12,563

 

16,760

 

16,600

 

16,219

 

17,246

 

37

%

31,429

 

56,001

 

33,465

 

Interest expense

 

(4,035

)

(3,772

)

(3,233

)

(4,188

)

(3,621

)

10

%

(19,638

)

(15,478

)

(7,809

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes (1)

 

194,499

 

(28,564

)

(364,956

)

229,380

 

201,381

 

4

%

628,919

 

(52,678

)

430,761

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Provision for) benefit from income taxes(1)

 

(60,002

)

44,530

 

96,722

 

(71,193

)

(61,432

)

(2

)%

(187,430

)

35,881

 

(132,625

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)(1)

 

$

134,497

 

$

15,966

 

$

(268,234

)

$

158,187

 

$

139,949

 

4

%

$

441,489

 

$

(16,797

)

$

298,136

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share-diluted(1,6,7)

 

$

0.49

 

$

0.06

 

$

(1.02

)

$

0.57

 

$

0.51

 

4

%

$

1.65

 

$

(0.06

)

$

1.08

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding-diluted(1,6,7)

 

276,312

 

278,271

 

262,803

 

279,924

 

280,564

 

2

%

272,224

 

261,124

 

280,244

 

 

15




 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

YTD

 

 

 

Q2-06

 

Q3-06

 

Q4-06

 

Q1-07

 

Q2-07

 

FY 2005

 

FY 2006

 

6/30/07

 

Total product and service revenue

 

$

789,747

 

$

805,384

 

$

848,239

 

$

874,071

 

$

927,957

 

$

2,714,682

 

$

3,169,527

 

$

1,802,028

 

As a % of total product and service revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renagel phosphate binder (including Sevelamer)

 

16

%

17

%

16

%

16

%

16

%

15

%

16

%

16

%

Hectorol

 

3

%

3

%

3

%

3

%

3

%

1

%

3

%

3

%

Cerezyme enzyme

 

32

%

31

%

31

%

30

%

31

%

34

%

32

%

30

%

Fabrazyme enzyme

 

11

%

11

%

11

%

12

%

11

%

11

%

11

%

11

%

Thyrogen hormone

 

3

%

3

%

3

%

3

%

3

%

3

%

3

%

3

%

Myozyme enzyme

 

1

%

3

%

3

%

4

%

5

%

0

%

2

%

5

%

Thymoglobulin/
Lymphoglobuline

 

5

%

5

%

5

%

5

%

4

%

5

%

5

%

4

%

Synvisc viscosupplementation product and services

 

8

%

7

%

7

%

6

%

7

%

8

%

7

%

7

%

Sepra products

 

3

%

3

%

3

%

3

%

3

%

3

%

3

%

3

%

Genetics testing

 

8

%

8

%

7

%

7

%

8

%

8

%

8

%

8

%

Other

 

10

%

10

%

11

%

11

%

9

%

11

%

10

%

10

%

 

 

100

%

100

%

100

%

100

%

100

%

100

%

100

%

100

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total product and service gross margin

 

77

%

77

%

77

%

77

%

77

%

77

%

77

%

77

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

793,356

 

$

808,574

 

$

854,241

 

$

883,183

 

$

933,419

 

$

2,734,842

 

$

3,187,013

 

$

1,816,602

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SG&A expense as a % of total revenue

 

34

%

30

%

31

%

30

%

30

%

29

%

32

%

30

%

R&D expense as a % of total revenue

 

21

%

20

%

19

%

19

%

22

%

18

%

20

%

20

%

Operating income (loss) as a % of total revenue

 

14

%

(6

)%

(45

)%

22

%

19

%

22

%

(6

)%

21

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

31

%

156

%

27

%

31

%

31

%

30

%

68

%

31

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheet Information:

 

6/30/06

 

9/30/06

 

12/31/06

 

3/31/07

 

6/30/07

 

12/31/05

 

12/31/06

 

6/30/07

 

Cash and all marketable securities

 

$

1,358,240

 

$

1,675,599

 

$

1,285,604

 

$

1,450,125

 

$

1,500,148

 

$

1,089,102

 

$

1,285,604

 

$

1,500,148

 

Other current assets

 

1,392,290

 

1,319,235

 

1,377,437

 

1,436,061

 

1,504,093

 

1,179,093

 

1,377,437

 

1,504,093

 

Property, plant and equipment, net

 

1,458,222

 

1,513,632

 

1,610,593

 

1,670,848

 

1,742,651

 

1,320,813

 

1,610,593

 

1,742,651

 

Intangibles, net (4)

 

3,028,777

 

2,773,653

 

2,790,819

 

2,756,036

 

2,717,921

 

3,078,461

 

2,790,819

 

2,717,921

 

Other assets

 

135,342

 

142,919

 

126,735

 

161,595

 

192,490

 

211,396

 

126,735

 

192,490

 

Total assets

 

$

7,372,871

 

$

7,425,038

 

$

7,191,188

 

$

7,474,665

 

$

7,657,303

 

$

6,878,865

 

$

7,191,188

 

$

7,657,303

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

616,632

 

$

552,091

 

$

651,439

 

$

661,321

 

$

645,798

 

$

550,023

 

$

651,439

 

$

645,798

 

Noncurrent liabilities

 

1,111,591

 

1,088,114

 

879,038

 

866,893

 

866,068

 

1,178,975

 

879,038

 

866,068

 

Stockholders’ equity

 

5,644,648

 

5,784,833

 

5,660,711

 

5,946,451

 

6,145,437

 

5,149,867

 

5,660,711

 

6,145,437

 

Total liabilities and stockholders’ equity

 

$

7,372,871

 

$

7,425,038

 

$

7,191,188

 

$

7,474,665

 

$

7,657,303

 

$

6,878,865

 

$

7,191,188

 

$

7,657,303

 

 

16




 

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 of 2006 and 2007 presented, we recorded pre-tax charges for stock-based compensation expense and related tax benefits of:

 

 

 

 

 

 

 

 

 

 

 

YTD

 

YTD

 

 

 

Q2-06

 

Q3-06

 

Q4-06

 

Q1-07

 

Q2-07

 

12/31/06

 

6/30/07

 

Cost of products and services sold

 

$

(4,927

)

$

(5,663

)

$

(8,537

)

$

(5,896

)

$

(6,879

)

$

(21,430

)

$

(12,775

)

Selling, general and administrative expense

 

(52,692

)

(24,421

)

(25,262

)

(22,499

)

(43,018

)

(121,822

)

(65,517

)

Research and development expense

 

(25,269

)

(14,556

)

(14,566

)

(12,312

)

(21,862

)

(65,248

)

(34,174

)

Total pre-tax charges for stock compensation expense

 

(82,888

)

(44,640

)

(48,365

)

(40,707

)

(71,759

)

(208,500

)

(112,466

)

Tax benefit

 

27,577

 

14,312

 

14,094

 

12,432

 

20,782

 

66,331

 

33,214

 

Stock-based compensation expense, net of tax

 

$

(55,311

)

$

(30,328

)

$

(34,271

)

$

(28,275

)

$

(50,977

)

$

(142,169

)

$

(79,252

)

 

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 $(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.

(3)             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.

(4)             Represents the write off of the goodwill related to our Genetics reporting unit.  In accordance with FAS 142, “Goodwill and Other Intangible Assets,” we completed the annual impairment tests for our $1.3 billion of net goodwill in the third quarter of 2006 and determined that the fair value of the net assets of our Genetics reporting unit was lower than the carrying value, indicating potential impairment.  Based on our analysis, we concluded that the goodwill assigned to our Genetics reporting unit is fully impaired.

(5)             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.

(6)             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 each of those periods.

(7)             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 for purposes of computing diluted earnings per share, unless the effect would be anti-dilutive.

17