EX-99.1 2 a09-5236_1ex99d1.htm EX-99.1

Exhibit 99.1

 

For Immediate Release

 

Media Contact:

 

Investor Contact:

February 11, 2009

 

Erin Emlock

 

Patrick Flanigan

 

 

(617) 768-6923

 

(617) 768-6563

 

 

Strong Fourth Quarter for Genzyme Concludes Productive Year

 


 

Non-GAAP EPS Reaches $1.04 in Fourth Quarter and $4.00 for 2008

 


 

Company Provides Confident Outlook for 2009

 

CAMBRIDGE, Mass. — Genzyme Corp. (NASDAQ: GENZ) today announced solid fourth-quarter revenue and earnings growth and provided guidance for 2009 that underscored its positive outlook for the year.

 

GAAP net income rose to $86.7 million, or $0.31 per diluted share, compared with $78.9 million, or $0.29 per diluted share, in the prior fourth quarter.  Non-GAAP net income increased 16 percent to $288.5 million compared with $249.2 million in the fourth quarter of 2007.  Non-GAAP earnings rose 14 percent to $1.04 per diluted share from $0.91 per diluted share in the same period in 2007.

 

GAAP figures for the quarter include a non refundable upfront fee to Osiris Therapeutics Inc. for a late-stage product candidate, amortization and stock compensation expenses, and a charge to write off overhead and material associated with incomplete process validation runs at the company’s Belgium manufacturing facility.

 

“We had an excellent year last year and exceeded our earnings expectations despite the economic environment and the challenges we faced with Myozyme,” said Henri A. Termeer, Genzyme chairman and chief executive officer.  “We delivered on our

 



 

financial objectives but did not ignore our future.  We continued to expand and invest in our pipeline and now have seven exciting late-stage programs with the potential to sustain our growth over the long term.  Genzyme is stronger today than it was a year ago, and we feel confident about our future.”

 

As previously announced, fourth-quarter revenue rose 13 percent to $1.17 billion, reflecting an approximate $39 million negative impact of foreign exchange, compared with $1.04 billion in the same period in 2007.

 

Individual product sales for the fourth quarter and the year, along with expectations for the longer-term growth of Genzyme’s business segments, were detailed in a January 13, 2009, press release coinciding with the company’s presentation at the JPMorgan Healthcare Conference.

 

2008 Results

 

Total revenue in 2008 increased 21 percent to $4.6 billion from $3.8 billion in 2007.  GAAP net income was $421.1 million, or $1.50 per diluted share, compared with $480.2 million, or $1.74 per diluted share, in 2007.  Non-GAAP net income increased 18 percent to $1.1 billion, compared with $939.9 million in 2007.  Non-GAAP earnings increased 15 percent to $4.00 per diluted share from $3.47 in 2007.

 

Genzyme generated approximately $1.5 billion in cash predominantly from operations in 2008 and utilized this cash flow to substantially eliminate all debt, invest in its global infrastructure, repurchase shares, and complete strategic transactions that significantly strengthened its late-stage pipeline.

 

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Financial Guidance for 2009

 

Earnings

 

·                  Genzyme is on-track to achieve its goal of 20 percent compound average non-GAAP earnings growth from 2006 — 2011.  Non-GAAP earnings are projected to rise to approximately $7.00 per diluted share by 2011.

 

·                  Non-GAAP earnings in 2009 are expected to increase to $4.70 per diluted share.  GAAP earnings, which include amortization and stock compensation expenses, are expected to reach $3.50 per diluted share.

 

·                  Non-GAAP earnings in the first quarter of 2009 are expected to be similar to earnings for the fourth quarter of 2008.  Genzyme anticipates that its non-GAAP earnings will accelerate starting in the second quarter, as two key regulatory approvals for Myozyme® (alglucosidase alfa) are secured: E.U. approval of Myozyme produced at the 4000 L scale, which will help provide the capacity to meet the strong global demand for the product; and U.S. approval of Myozyme produced at the 2000 L scale, which will be called Lumizyme (alglucosidase alfa), giving the company the ability to promote the Pompe disease therapy produced at this scale in the U.S. market.  Mozobil (plerixafor injection), which was launched last month, will also help drive earnings growth.

 

Revenue

 

·                  Revenue is expected to reach $5.2 — $5.4 billion in 2009.  This reflects an approximate $150 million unfavorable impact of foreign exchange.  Genzyme anticipates strong volume growth in all five of its business segments:

 

Total revenue for the Genetic Disease segment is expected to reach $2.47 — $2.53 billion this year, compared with $2.23 billion in 2008.

 

·                  Within this segment, Myozyme revenue is expected to increase to $430 — $440 million, compared with $296 million in 2008.  The company anticipates FDA action by February 28 on its filing for U.S. approval of Lumizyme.  European Commission approval of Myozyme produced at the 4000 L scale would be expected in April under the standard review procedure.  Genzyme has requested expedited review of its application.

 

·                  Revenue for Fabrazyme® (agalsidase beta), an important growth driver that is performing well in a competitive marketplace, is expected to rise to $560 — $570 million in 2009 from $494 million last year.

 

·                  Cerezyme® (imiglucerase for injection) revenue is expected to reach $1.25 — $1.28 billion, compared with $1.24 billion in 2008, reflecting its mature status and the impact of foreign exchange.

 

The Cardiometabolic and Renal segment’s total revenue is expected to increase to $1.04 — $1.07 billion this year, compared with $956 million in 2008.

 

3



 

·                  Within this segment, Genzyme’s sevelamer therapies, Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride), are expected to produce revenues of $725 — $735 million in 2009, compared with $678 million last year.  Anticipated key drivers include E.U. approval of Renvela and the expansion of the product’s U.S. indication to include the treatment of patients with chronic kidney disease who are not on dialysis, both of which are expected in mid-2009.  Genzyme is working to transition all remaining U.S. Renagel patients to Renvela, with the goal of completing the transition by September 30, 2009.

 

Total revenue for the Biosurgery segment is expected to reach $540 — $570 million this year, compared with $491 million in 2008.

 

·                  FDA approval for Synvisc-One is expected soon, and the product is expected to be a significant growth driver for the franchise over the longer term.

 

The Hematologic Oncology segment’s total revenue is expected to rise to $185 — $210 million this year, compared with $117 million in 2008.

 

·                  Within this segment, Mozobil revenue in 2009 is expected to reach $40 — $50 million.  The launch of this treatment is going well, with broad adoption by transplant centers.  Mozobil was approved in the United States in December, and E.U. approval is expected in the second half of 2009.  Genzyme expects that the product will become an integral part of the treatment regimen for stem-cell transplantation because of the clinical and economic benefits it offers to patients, physicians and transplant centers.

 

Other revenue is expected to reach $1.02 — $1.08 billion in 2009, compared with $814 million in 2008.

 

·                  This segment includes revenue from the company’s Genetics, Diagnostics, Transplant and Pharmaceuticals businesses, and other product revenue.

 

Gross Margin

 

·                  The non-GAAP gross margin for 2009 is expected to be approximately 75 percent of revenues, compared with 76 percent in 2008.  The gross margin reflects underutilized capacity at the two plants where larger scale production of Myozyme is starting to come online.  It also reflects changes in product mix.

 

Expenses

 

·                  Non-GAAP selling, general and administrative expenses are expected to represent approximately 26 percent of revenue in 2009, lower than SG&A expenses of 27 percent of revenue in 2008.  SG&A spending this year will reflect several major

 

4



 

product launches, including Mozobil in the United States and Europe and Synvisc-One, Lumizyme, and Clolar® (clofarabine) for adult AML in the United States.

 

·                  Non-GAAP research and development spending is expected to represent approximately 16 percent of revenue in 2009, consistent as a percentage of revenue with R&D spending in 2008.  Genzyme continues to make a significant investment in its pipeline to sustain its future growth.  The company is currently conducting approximately 100 clinical trials.

 

Tax Rate

 

·                  Genzyme’s non-GAAP tax rate this year is expected to be approximately 29 percent.  The GAAP tax rate is expected to be 30 percent.

 

Capital Expenditures

 

·                  Capital expenditures are expected to total $600 — $650 million this year.  Genzyme continues to make a significant investment in manufacturing capacity to support the growth of existing products and prepare for the launch of products in late-stage development.  Construction is underway on two new manufacturing facilities: one for Thymoglobulin® (anti-thymocyte globulin, rabbit) in France, and one for cell culture production in Framingham, Mass.

 

Development Programs

 

Genzyme’s R&D pipeline includes seven major late-stage programs with the potential to sustain the company’s growth beyond 2011:

 

Clolar for adult AML

 

Genzyme has filed for FDA approval of Clolar as a first-line therapy for adult acute myeloid leukemia.  If this application receives priority review, Clolar could be approved for this indication in the first half of 2009.  An E.U. filing is anticipated in the second half of 2009, with approval expected in the first half of 2010.  Clolar is currently approved in the United States and Europe for the treatment of acute lymphoblastic leukemia in relapsed and refractory pediatric patients.

 

Alemtuzumab for multiple sclerosis

 

Genzyme continues to enroll patients in two phase 3 trials of alemtuzumab, which has the potential to become a new standard of care in the treatment of multiple sclerosis. Enrollment in the study involving previously untreated patients is expected to conclude by mid year, and enrollment in the study involving treatment-experienced patients is expected to conclude in the first half of next year.  The design of the latter study has been modified to eliminate its high-dose arm based on final phase 2 data showing that both the high and low doses of alemtuzumab were efficacious when compared to

 

5



 

interferon beta-1a.  Results for the treatment naïve study are expected in 2011, and Genzyme anticipates approval of alemtuzumab in 2012.

 

Mipomersen for high-risk hypercholesterolemia

 

Genzyme and Isis Pharmaceuticals Inc. formed a collaboration in 2008 to develop and commercialize the novel lipid-lowering drug mipomersen for patients with high cholesterol who are at high risk of cardiovascular disease.  The companies have begun three late-stage studies of mipomersen during the past year, and a fourth is currently screening patients.  The companies have also completed enrollment in a phase 3 trial involving patients with homozygous familial hypercholesterolemia.  Top-line data are expected in mid-2009.  The submission of a U.S. marketing application for this indication is anticipated during the second half of 2010, and the first approval is expected in 2011.  An outcome study is expected to begin by mid-2010.

 

Prochymal for graft vs. host disease and Crohn’s disease

 

Genzyme and Osiris Therapeutics Inc. formed a collaboration last year to develop and commercialize the adult stem cell treatment Prochymal.  Data from phase 3 studies of Prochymal in graft vs. host disease (GvHD) and Crohn’s disease are expected in 2009, and Osiris also expects to seek FDA approval for the GvHD indication this year.

 

GENZ-112638 for Gaucher disease

 

Genzyme is preparing to initiate two phase 3 studies of Genz-112638, a potential oral therapy for Gaucher disease, following the positive outcome of a recent meeting with the FDA to discuss study design.  Patient enrollment is expected to begin during the first half of the year.  Final results from the open-label phase 2 study will be presented February 20 at the Lysosomal Disease Network’s WORLD Symposium.

 

Ataluren for Duchenne muscular dystrophy

 

Genzyme and PTC Therapeutics Inc. formed a collaboration in 2008 to develop and commercialize ataluren (formerly known as PTC124), a novel oral therapy for the treatment of genetic disorders due to nonsense mutations, which is potentially applicable to hundreds of diseases.  A pivotal phase 2b trial of ataluren in Duchenne muscular dystrophy (DMD) is fully enrolled and results are expected next year.  A trial in cystic fibrosis (CF) is expected to begin during the first half of this year.

 

Other Key Programs

 

Genzyme expects to begin a pivotal trial of an advanced phosphate binder (APB) this year.  The APB is designed to more effectively bind phosphate for a substantial improvement in potency over existing therapies while maintaining all the benefits of sevelamer.  The company anticipates that the APB will be approved by the time the core patent estate for sevelamer expires in 2014.

 

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During the first half of 2010, Genzyme expects to file an IND for a potential second-generation enzyme replacement therapy for Pompe disease that in preclinical studies to date has demonstrated a five-fold greater substrate clearance vs. alglucosidase alfa.

 

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 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 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.

 

With many established products and services helping patients in approximately 100 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 immune disease, and diagnostic testing.  Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.

 

This press release contains forward-looking statements regarding Genzyme financial outlook and business plans and strategies, including without limitation: its anticipated compound average earnings growth rate from 2006-2011; its Q1 2009, YE 2009 and YE 2011 EPS guidance and drivers of EPS growth; its projected 2009 revenues for the company, for each business segment, for certain products, including Myozyme, Fabrazyme, Cerezyme, Renagel/Renvela, and Mozobil, and all other revenues, as well as the anticipated drivers of such revenue growth; the expected timing of receipt of regulatory approvals for alglucosidase alfa produced at the 2000L scale in the US and 4000L scale in the EU; its regulatory approval plans and timetables for existing products, including EU approval of Renvela, US approval of Renvela for use in CKD patients not on dialysis, EU approval of Mozobil, US approval of Synvisc-One, US and EU approval of Clolar for use in adult patients with AML, and US approval of alemtuzumab-MS; its plans and estimated timetables for new and next-generation product filings and approvals, including for mipomersen, Genz-112638, Prochymal, Ataluren, and APB; its projected 2009 non-GAAP gross margin, SG&A and R&D expenses as a percentage of revenues; its expected 2009 GAAP and non-GAAP tax rates; and its projected 2009 capital expenditures. 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: the ability of Genzyme and its collaboration partners to successfully complete preclinical and clinical development of new products, including mipomersen, Prochymal, Genz-112638, and Ataluren; Genzyme’s ability to expand the use of current and next-generation products in existing and new indications, including Renvela, Synvisc-ONE, Mozobil, Clolar, alemtuzumab-MS and the APB;

 

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Genzyme’s ability to obtain and maintain regulatory approvals for products and manufacturing facilities, including alglucosidase alfa produced at the 2000L and 4000L scales 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 September 30, 2008. 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®, Renagel®, Renvela®, Synvisc®, and Clolar® are registered trademarks and Mozobil™, Synvisc-One™ and Lumizyme™ are trademarks of Genzyme Corporation or its subsidiaries.  Prochymal is a trademark of Osiris Therapeutics Inc.  All rights reserved.

 

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.

 

Conference Call Information

 

Genzyme will host a conference call today at 11:00 a.m. Eastern.   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 February 18, 2009.

 

Upcoming Events

 

Genzyme will host a conference call on April 22 at 11: 00 a.m. Eastern to discuss financial results for the first quarter of 2009.  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 April 29, 2009.

 

#     #     #

 

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GENZYME CORPORATION (GENZ)

Consolidated Statements of Operations
(Unaudited, amounts in thousands, except per share amounts)

 

 

Three Months Ended

 

Year Ended

 

 

 

December 31,

 

December 31,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

1,173,560

 

$

1,036,758

 

$

4,605,039

 

$

3,813,519

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of products and services sold

 

290,711

 

262,657

 

1,148,562

 

927,330

 

Selling, general and administrative

 

341,329

 

308,377

 

1,338,190

 

1,187,184

 

Research and development

 

358,430

 

197,323

 

1,308,330

 

737,685

 

Amortization of intangibles

 

59,884

 

51,804

 

226,442

 

201,105

 

Charge for impaired assets

 

2,036

 

 

2,036

 

 

Purchase of in-process research and development

 

 

106,350

 

 

106,350

 

Total operating costs and expenses

 

1,052,390

 

926,511

 

4,023,560

 

3,159,654

 

Operating income

 

121,170

 

110,247

 

581,479

 

653,865

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Equity in income of equity method investments

 

13

 

8,489

 

201

 

7,398

 

Minority interest

 

625

 

 

2,217

 

3,932

 

Gain (loss) on investments in equity securities, net

 

861

 

(969

)

(3,340

)

13,067

 

Other

 

(1,021

)

(747

)

(1,861

)

(637

)

Investment income

 

11,245

 

18,509

 

51,260

 

70,196

 

Interest expense

 

(822

)

(2,864

)

(4,418

)

(12,147

)

Total other income (expenses)

 

10,901

 

22,418

 

44,059

 

81,809

 

Income before income taxes

 

132,071

 

132,665

 

625,538

 

735,674

 

Provision for income taxes

 

(45,421

)

(53,766

)

(204,457

)

(255,481

)

Net income

 

$

86,650

 

$

78,899

 

$

421,081

 

$

480,193

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.32

 

$

0.30

 

$

1.57

 

$

1.82

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

$

0.31

 

$

0.29

 

$

1.50

 

$

1.74

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

270,658

 

265,418

 

268,490

 

263,895

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

284,338

 

283,374

 

285,595

 

280,767

 

 


All amounts herein are presented in accordance with GAAP and are provided for quantitative analysis only and should be read in conjunction with the text of the Earnings Release. In addition, Genzyme believes that certain non-GAAP financial measures, when considered together with the GAAP figures, can enhance the overall understanding of Genzyme’s past financial performance and its prospects for the future. Please refer to our GAAP to Non-GAAP Reconciliations attached to the Earnings Releases for the above respective periods, which are included in the Investors section of our website at www.genzyme.com. The non-GAAP financial measures are provided with the intent of providing investors with a more complete understanding of the trends underlying our operating results and financial position and are among the primary indicators Genzyme management uses for planning and forecasting purposes and measuring the company’s performance.

 

Please refer to our Form 10-Q’s and Form 10-K’s for an in-depth discussion and analysis of our results of operations and financial position and for detailed information regarding specific material transactions in a particular period.

 

(1)          In accordance with EITF 04-8, the shares issuable upon conversion of our $690.0 million in principal of 1.25% convertible senior notes are included in diluted weighted average shares outstanding for purposes of computing diluted earnings per share, unless the effect would be anti-dilutive. The notes were redeemed for primarily cash on December 1, 2008. Accordingly, interest and debt fees related to these notes of $1.3 million and $1.9 million, net of tax, for the three months ended December 31, 2008 and 2007, respectively, and $6.9 million and $7.5 million, net of tax, for the years ended December 31, 2008 and 2007, respectively, have been added back to net income. Approximately 6.4 million shares and 8.9 million shares issuable upon conversion of these notes prior to redemption have been included in diluted weighted average shares outstanding for the three months ended and the year ended December 31, 2008, respectively. Approximately 9.7 million shares issuable upon conversion of these notes have been included in diluted weighted average shares outstanding for the same periods of 2007.

 



 

GENZYME CORPORATION (GENZ)
Condensed Consolidated Balance Sheets

(Unaudited, amounts in thousands)

 

 

December 31,

 

December 31,

 

 

 

2008

 

2007

 

 

 

 

 

 

 

Cash and all marketable securities

 

$

973,775

 

$

1,460,394

 

Other current assets

 

1,852,220

 

1,661,740

 

Property, plant and equipment, net

 

2,306,567

 

1,968,402

 

Intangibles, net (1)

 

3,285,298

 

2,959,480

 

Other noncurrent assets

 

518,764

 

251,725

 

Total assets

 

$

8,936,624

 

$

8,301,741

 

 

 

 

 

 

 

Current liabilities

 

$

914,265

 

$

1,502,406

 

Noncurrent liabilities (1)

 

687,163

 

186,398

 

Stockholders’ equity

 

7,335,196

 

6,612,937

 

Total liabilities and stockholders’ equity

 

$

8,936,624

 

$

8,301,741

 

 


(1)     Effective January 1, 2008, in connection with the restructuring of BioMarin/Genzyme LLC, our joint venture with BioMarin Pharmaceutical Inc., we licensed certain rights to commercialize Aldurazyme from the joint venture and began consolidating the results of the joint venture at fair value in accordance with FIN 46R.  As of December 31, 2008, intangibles, net, and noncurrent liabilities each include a net $456,475K for the fair values associated with the joint venture’s manufacturing and commercialization rights to Aldurazyme. Excluding these rights, the fair value of the assets and liabilities of the joint venture as of December 31, 2008 was not significant.

 



 

Genzyme Corporation (GENZ)

Analyst Schedule

(Unaudited, amounts in thousands, except percentage amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

Q4-08
vs.
Q4-07

 

 

 

 

 

 

 

 

 

Q4-07

 

Q1-08

 

Q2-08

 

Q3-08

 

Q4-08

 

% B/(W)

 

FY 2006

 

FY 2007

 

FY 2008

 

Total revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic Diseases

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cerezyme

 

$

300,312

 

$

304,303

 

$

319,360

 

$

309,280

 

$

306,034

 

2

%

$

1,007,036

 

$

1,133,153

 

$

1,238,977

 

Fabrazyme

 

114,661

 

116,475

 

126,608

 

125,619

 

125,558

 

10

%

359,274

 

424,284

 

494,260

 

Myozyme

 

62,496

 

67,324

 

77,222

 

76,663

 

74,967

 

20

%

59,238

 

200,728

 

296,176

 

Aldurazyme

 

 

37,015

 

38,834

 

38,236

 

37,579

 

 

 

 

 

151,664

 

Other Genetic Diseases

 

7,289

 

9,772

 

10,437

 

11,367

 

14,039

 

93

%

410

 

8,314

 

45,615

 

Total Genetic Diseases product and service revenue

 

484,758

 

534,889

 

572,461

 

561,165

 

558,177

 

15

%

1,425,958

 

1,766,479

 

2,226,692

 

R&D Revenue

 

5

 

 

 

 

 

 

 

1,000

 

1,059

 

 

Total Genetic Diseases

 

484,763

 

534,889

 

572,461

 

561,165

 

558,177

 

15

%

1,426,958

 

1,767,538

 

2,226,692

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiometabolic and Renal

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renagel and Renvela (including Sevelamer)

 

166,173

 

168,694

 

168,567

 

170,992

 

169,476

 

2

%

515,119

 

602,670

 

677,729

 

Hectorol

 

29,855

 

29,076

 

30,852

 

33,825

 

34,400

 

15

%

93,360

 

115,708

 

128,153

 

Subtotal

 

196,028

 

197,770

 

199,419

 

204,817

 

203,876

 

4

%

608,479

 

718,378

 

805,882

 

Thyrogen

 

30,881

 

33,785

 

39,448

 

38,153

 

37,062

 

20

%

93,687

 

113,587

 

148,448

 

Other Cardiometabolic and Renal

 

92

 

251

 

333

 

573

 

496

 

>100

%

 

103

 

1,653

 

Total Cardiometabolic and Renal product and service revenue

 

227,001

 

231,806

 

239,200

 

243,543

 

241,434

 

6

%

702,166

 

832,068

 

955,983

 

R&D revenue

 

102

 

32

 

85

 

56

 

27

 

(74

)%

2,142

 

1,200

 

200

 

Total Cardiometabolic and Renal

 

227,103

 

231,838

 

239,285

 

243,599

 

241,461

 

6

%

704,308

 

833,268

 

956,183

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Biosurgery

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Synvisc

 

62,685

 

56,142

 

70,927

 

67,513

 

68,512

 

9

%

233,858

 

242,319

 

263,094

 

Sepra products

 

29,746

 

30,604

 

34,780

 

33,001

 

35,278

 

19

%

85,338

 

104,318

 

133,663

 

Other Biosurgery

 

21,122

 

24,313

 

24,690

 

21,787

 

20,908

 

(1

)%

67,480

 

74,673

 

91,698

 

Total Biosurgery product and service revenue

 

113,553

 

111,059

 

130,397

 

122,301

 

124,698

 

10

%

386,676

 

421,310

 

488,455

 

R&D revenue

 

666

 

603

 

818

 

661

 

563

 

(15

)%

893

 

5,337

 

2,645

 

Total Biosurgery

 

114,219

 

111,662

 

131,215

 

122,962

 

125,261

 

10

%

387,569

 

426,647

 

491,100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hematologic Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Hematologic Oncology product and service revenue

 

21,628

 

22,691

 

26,443

 

26,328

 

27,437

 

27

%

49,179

 

69,927

 

102,899

 

R&D revenue

 

1,216

 

1,189

 

1,903

 

2,292

 

9,055

 

>100

%

8,097

 

7,006

 

14,439

 

Total Hematologic Oncology

 

22,844

 

23,880

 

28,346

 

28,620

 

36,492

 

60

%

57,276

 

76,933

 

117,338

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic/Diagnostics product and service revenue

 

108,872

 

114,748

 

116,863

 

121,163

 

124,840

 

15

%

355,866

 

410,917

 

477,614

 

Transplant product and service revenue

 

47,424

 

45,930

 

47,763

 

47,784

 

50,723

 

7

%

155,966

 

174,826

 

192,200

 

Other product and service revenue

 

27,981

 

31,009

 

29,296

 

28,598

 

30,252

 

8

%

93,716

 

108,577

 

119,155

 

Total Other product and service revenue

 

184,277

 

191,687

 

193,922

 

197,545

 

205,815

 

12

%

605,548

 

694,320

 

788,969

 

R&D revenue

 

3,552

 

6,105

 

5,905

 

6,393

 

6,354

 

79

%

5,354

 

14,813

 

24,757

 

Total Other

 

187,829

 

197,792

 

199,827

 

203,938

 

212,169

 

13

%

610,902

 

709,133

 

813,726

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

1,036,758

 

$

1,100,061

 

$

1,171,134

 

$

1,160,284

 

$

1,173,560

 

13

%

$

3,187,013

 

$

3,813,519

 

$

4,605,039

 

 

All amounts herein are presented in accordance with GAAP and are provided for quantitative analysis only and should be read in conjunction with the text of the Earnings Release and our audited financial statements filed with the Securities and Exchange Commission.  Please refer to our Form 10-Q’s and Form 10-K’s for an in-depth discussion and analysis of our results of operations and financial position and for detailed information regarding specific material transactions in a particular period.

 



GENZYME CORPORATION

RECONCILIATION OF GAAP TO NON-GAAP EARNINGS

For the Three Months Ended December 31, 2008

(Amounts in thousands, except percentage and per share data)

 

 

 

 

 

 

 

(1)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Dilution

 

(2)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Due to

 

Validation/

 

(3)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

Inventory

 

License

 

 

 

FAS 123R

 

GAAP

 

 

 

NON-GAAP

 

Equivalents

 

Write-offs

 

Fee

 

Amortization

 

Expense

 

As Reported

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income Statement Classification:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

 

 

$

1,173,560

 

 

 

 

 

 

 

 

 

 

 

 

 

$

1,173,560

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of products and services sold

 

 

 

$

(270,293

)

 

 

$

(12,614

)

 

 

 

 

$

(7,804

)

 

 

$

(290,711

)

Gross margin

 

77

%

$

903,267

 

 

 

$

(12,614

)

 

 

 

 

$

(7,804

)

75

%

$

882,849

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

 

$

(317,599

)

 

 

 

 

 

 

 

 

$

(23,730

)

 

 

$

(341,329

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

$

(188,040

)

 

 

$

(11,039

)

$

(146,000

)

 

 

$

(13,351

)

 

 

$

(358,430

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangibles

 

 

 

$

 

 

 

 

 

 

 

$

(59,884

)

 

 

 

 

$

(59,884

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Charge for impaired asset

 

 

 

$

(2,036

)

 

 

 

 

 

 

 

 

 

 

 

 

$

(2,036

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity in income (loss) of equity method investments

 

 

 

$

13

 

 

 

 

 

 

 

 

 

 

 

 

 

$

13

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Minority interest

 

 

 

$

625

 

 

 

 

 

 

 

 

 

 

 

 

 

$

625

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gains (losses) on investments in equity securities

 

 

 

$

861

 

 

 

 

 

 

 

 

 

 

 

 

 

$

861

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

$

(1,021

)

 

 

 

 

 

 

 

 

 

 

 

 

$

(1,021

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

 

 

$

11,245

 

 

 

 

 

 

 

 

 

 

 

 

 

$

11,245

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

 

$

(822

)

 

 

 

 

 

 

 

 

 

 

 

 

$

(822

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

 

$

406,493

 

$

 

$

(23,653

)

$

(146,000

)

$

(59,884

)

$

(44,885

)

 

 

$

132,071

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Provision for) benefit from income taxes

 

29

%

$

(118,006

)

$

 

$

5,724

 

$

52,401

 

$

1,116

 

$

13,344

 

34

%

$

(45,421

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

 

 

$

288,487

 

$

 

$

(17,929

)

$

(93,599

)

$

(58,768

)

$

(31,541

)

 

 

$

86,650

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

$

1.07

 

$

 

$

(0.07

)

$

(0.35

)

$

(0.22

)

$

(0.12

)

 

 

$

0.32

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

 

 

$

1.04

 

$

(0.02

)

$

(0.06

)

$

(0.33

)

$

(0.21

)

$

(0.11

)

 

 

$

0.31

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

270,658

 

 

 

 

 

 

 

 

 

 

 

 

 

270,658

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

 

 

277,928

 

6,410

 

 

 

 

 

 

 

 

 

 

 

284,338

 

 



 

GENZYME CORPORATION

RECONCILIATION OF GAAP to NON-GAAP CASH GENERATED

For the Three Months Ended December 31, 2008

(Amounts in thousands)

 

Non-GAAP Net Income

 

$

288,487

 

 

 

 

 

Depreciation, net of tax

 

24,684

 

 

 

 

 

Proceeds from the issuance of common stock

 

24,150

 

 

 

 

 

Non-GAAP Cash Generated

 

$

337,321

 

 


Notes:

 

The amounts above represent the Non-GAAP operations and financial position of Genzyme Corporation for the three months ended December 31, 2008.  Genzyme believes that certain non-GAAP financial measures, when considered together with the GAAP figures, can enhance the 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 investors with a more complete understanding of the trends underlying our operating results and financial position and are among the primary indicators Genzyme management uses for planning and forecasting purposes and measuring the company’s performance.  Such non-GAAP financial measures should not be considered in isolation or used as a substitute for GAAP.

 

(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 $1,257K, net of tax, have been added back to net income and approximately 6,410K shares have been added to diluted weighted average shares outstanding for purposes of computing GAAP As-Reported diluted earnings per share.

 

(2)  Represents the write-off of inventory associated with partial production runs $(12,614)K and validation costs associated with our Belgium facility $(11,039)K.

 

(3)  Represents an up-front expense for the license or purchase of certain intellectual property and technology, of which $(130,000)K relates to our collaboration with Osiris Therapeutics, Inc.; and $(10,000)K and $(6,000)K each relate to transactions with two other third parties.

 



 

GENZYME CORPORATION

RECONCILIATION OF GAAP TO NON-GAAP EARNINGS

Year to Date as of December 31, 2008

(Amounts in thousands, except percentage and per share data)

 

 

 

 

 

 

 

Dilution

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Due to

 

Validation/

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

Inventory

 

Strategic Equity

 

Gain (Loss) on

 

License

 

 

 

FAS 123R

 

GAAP

 

 

 

NON-GAAP

 

Equivalents

 

Write-offs

 

Investment

 

Investments

 

Fees

 

Amortization

 

Expense

 

As Reported

 

Income Statement Classification:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

 

 

$

4,605,039

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

4,605,039

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of products and services sold

 

 

 

$

(1,108,393

)

 

 

$

(12,614

)

 

 

 

 

 

 

 

 

$

(27,555

)

 

 

$

(1,148,562

)

Gross margin

 

76

%

$

3,496,646

 

 

 

$

(12,614

)

 

 

 

 

 

 

 

 

$

(27,555

)

75

%

$

3,456,477

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

 

$

(1,235,445

)

 

 

 

 

 

 

 

 

 

 

 

 

$

(102,745

)

 

 

$

(1,338,190

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

$

(749,718

)

 

 

$

(11,039

)

$

(69,900

)

 

 

$

(421,000

)

 

 

$

(56,673

)

 

 

$

(1,308,330

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangibles

 

 

 

$

 

 

 

 

 

 

 

 

 

 

 

$

(226,442

)

 

 

 

 

$

(226,442

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Charge for impaired assets

 

 

 

$

(2,036

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

(2,036

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity in income (loss) of equity method investments

 

 

 

$

201

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

201

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Minority interest

 

 

 

$

2,217

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

2,217

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gains (losses) on investments in equity securities

 

 

 

$

1,913

 

 

 

 

 

 

 

$

(5,253

)

 

 

 

 

 

 

 

 

$

(3,340

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

$

(1,861

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

(1,861

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

 

 

$

51,260

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

51,260

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest Expense

 

 

 

$

(4,418

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

(4,418

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

 

$

1,558,759

 

$

 

$

(23,653

)

$

(69,900

)

$

(5,253

)

$

(421,000

)

$

(226,442

)

$

(186,973

)

 

 

$

625,538

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Provision for) benefit from income taxes

 

29

%

$

(451,038

)

$

 

$

5,724

 

$

13,428

 

$

390

 

$

94,900

 

$

75,399

 

$

56,740

 

33

%

$

(204,457

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

 

 

$

1,107,721

 

$

 

$

(17,929

)

$

(56,472

)

$

(4,863

)

$

(326,100

)

$

(151,043

)

$

(130,233

)

 

 

$

421,081

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

$

4.12

 

$

 

$

(0.07

)

$

(0.21

)

$

0.02

 

$

(1.21

)

$

(0.56

)

$

(0.50

)

 

 

$

1.57

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

 

 

$

4.00

 

$

(0.11

)

$

(0.06

)

$

(0.20

)

$

(0.01

)

$

(1.14

)

$

(0.53

)

$

(0.45

)

 

 

$

1.50

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

268,490

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

268,490

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

 

 

276,744

 

8,851

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

285,595

 

 



 

GENZYME CORPORATION

RECONCILIATION OF GAAP to NON-GAAP CASH GENERATED

For the Year Ended December 31, 2008

(Amounts in thousands)

 

 

 

Q1-08

 

Q2-08

 

Q3-08

 

Q4-08

 

2008

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Net Income

 

$

260,895

 

$

268,546

 

$

289,793

 

$

288,487

 

$

1,107,721

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation, net of tax

 

22,500

 

23,286

 

23,881

 

24,684

 

94,351

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from the issuance of common stock

 

90,243

 

36,765

 

167,595

 

24,150

 

318,753

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Cash Generated

 

$

373,638

 

$

328,597

 

$

481,269

 

$

337,321

 

$

1,520,825

 

 


Notes:

 

The amounts above represent the Non-GAAP operations and financial position of Genzyme Corporation in 2008.  A reconciliation of GAAP to Non-GAAP net income for each quarter is available in the investors section at www.genzyme.com.  Genzyme believes that certain non-GAAP financial measures, when considered together with the GAAP figures, can enhance the 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 investors with a more complete understanding of the trends underlying our operating results and financial position and are among the primary indicators Genzyme management uses for planning and forecasting purposes and measuring the company’s performance.  Such non-GAAP financial measures should not be considered in isolation or used as a substitute for GAAP.

 

(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 $6,915K, net of tax, have been added back to net income and approximately 8,851K shares have been added to diluted weighted average shares outstanding for purposes of computing GAAP As-Reported diluted earnings per share.

 



 

GENZYME 2009 GUIDANCE

 

 

 

2009 Guidance

 

DESCRIPTION

 

Ranges

 

Genetic Diseases

 

$

2,465

 

$

2,525

 

 

 

 

 

 

 

Cardiometabolic and Renal

 

1,035

 

1,065

 

 

 

 

 

 

 

Biosurgery

 

540

 

570

 

 

 

 

 

 

 

Hematologic Oncology

 

185

 

210

 

 

 

 

 

 

 

Other

 

1,020

 

1,075

 

TOTAL REVENUE

 

$

5,200

 

$

5,400

 

 

 

 

 

 

 

*GROSS MARGIN

 

approx.

 

75

%

 

 

 

 

 

 

*SG&A

 

approx.

 

26

%

*R&D

 

approx.

 

16

%

Net Interest / Other

 

approx.

 

30

 

 

 

 

 

 

 

TAX RATE - GAAP

 

approx.

 

30

%

*TAX RATE - NON-GAAP

 

approx.

 

29

%

 

 

 

 

 

 

GAAP EPS

 

approx.

 

$

3.50

 

AMORTIZATION

 

approx.

 

$

0.70

 

FAS123R EXPENSE

 

approx.

 

$

0.50

 

*NON-GAAP EPS

 

 

 

$

4.70

 

 

 

 

 

 

 

WTD AVERAGE DILUTED SHARES O/S

 

280

 

282

 

 

 

 

 

 

 

CAPITAL EXPENDITURES

 

$

600

 

$

650

 

 

This financial guidance, which is provided as part of a press release dated February 11, 2009, is subject to all of the qualifications and limitations described therein.  Actual results may differ from these forward-looking statements due to the numerous factors described in the press release.

 

*Non-GAAP excludes the impact of amortization, one-time events and FAS123R expense.

 

SELECT PRODUCT GUIDANCE:

 

 

 

 

 

Cerezyme

 

$

1,250

 

$

1,275

 

Fabrazyme

 

560

 

570

 

Myozyme

 

430

 

440

 

Mozobil

 

40

 

50

 

Renagel/Renvela

 

725

 

735