EX-99.1 2 a09-19333_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

For Immediate Release

 

Media Contact:

 

Investor Contact:

July 22, 2009

 

Erin Emlock

 

Patrick Flanigan

 

 

(617) 768-6923

 

(617) 768-6563

 

Genzyme Delivers Solid Second-Quarter Financial Results

 


 

Provides Updated 2009 Guidance

 


 

Reports Progress at Allston Manufacturing Facility

 

CAMBRIDGE, Mass. — Genzyme Corp. (NASDAQ: GENZ) today reported that second-quarter revenue rose to $1.23 billion, compared with $1.17 billion in the same period a year ago, an increase of 5 percent.  Including the $66 million impact of unfavorable currency exchange rates, revenue grew 11 percent in the second quarter.  Results reflect $13 million in lost revenue due to the interruption of Cerezyme® (imiglucerase for injection) shipments associated with the temporary shutdown of the company’s Allston manufacturing facility last month.

 

Second-quarter growth was driven by the reacceleration of Myozyme® (alglucosidase alfa) sales in Europe; strong U.S. launches of Synvisc-One (hylan G-F 20) and Mozobil® (plerixafor injection); new revenue from oncology products acquired from Bayer Healthcare; increased sales of Fabrazyme® (agalsidase beta); and double-digit growth in the company’s genetic testing business.

 

GAAP net income rose to $192.2 million, or $0.70 per diluted share, compared with $69.6 million, or $0.25 per diluted share, in the second quarter of 2008.  GAAP and non-GAAP net income in this year’s second quarter reflect the $15.7 million cost of remediation associated with the temporary shutdown of the Allston plant and the $6.6 million impact of the fair value step-up of inventory acquired from Bayer Healthcare.  GAAP net income in last year’s second quarter reflects a $175 million licensing fee associated with mipomersen.

 

Non-GAAP net income grew to $232.5 million, or $0.85 per diluted share, compared with $107.0 million, or $0.38 per diluted share, in the same period last year.  Non-GAAP net income excludes stock compensation and certain items associated with the purchase accounting for the Bayer business acquisition.

 

Genzyme generated approximately $281 million in cash during the second quarter, predominantly from operations.  The company used approximately $157 million primarily for investments in manufacturing.

 

“Results for the second quarter showed the strength of our diversified business, with many newer products, such as Synvisc-One, contributing to our growth,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer.  “We are working through the Allston manufacturing interruption in a constructive way.  At the same time, we are continuing to build the company for the future, making progress in our late-stage pipeline and bringing new products to patients.”

 



 

Allston Progress and Updated 2009 Guidance

 

Genzyme last month announced that it had detected a virus that impairs cell growth in a bioreactor used for Cerezyme production at its Allston facility.  The company decided to temporarily interrupt production at the plant — which was manufacturing Cerezyme, Fabrazyme and Myozyme — to sanitize the facility.

 

Genzyme has now completed the sanitization and is on-track to resume production at Allston this month.  When manufacturing resumes, Allston will be fully dedicated to the production of Cerezyme and Fabrazyme.  All Myozyme/Lumizyme™ (alglucosidase alfa) production will occur at the company’s 4000 L scale facility in Belgium.  Genzyme has already taken the initial steps in the cell culture process necessary for the re-start of production of Cerezyme and Fabrazyme at Allston.  The first release of both products is expected before the end of this year.

 

Cerezyme and Fabrazyme inventories are not sufficient to avoid shortages during the period of suspended production and recovery.  Genzyme is working closely with treating physicians, other health care providers, patient communities and regulatory officials worldwide to support patients with Gaucher and Fabry disease during the temporary period of supply constraint.  Treatment guidelines developed by expert physicians, patient group leaders and regulators are being implemented globally to help support doctors and patients in their decisions about product usage during this period, with the goal of conserving supply for the most vulnerable patients.

 

Genzyme is adjusting its 2009 financial guidance based on the estimated impact of the temporary Allston shutdown and revised assumptions about the timing of the expected availability of Lumizyme in the United States.

 

·      Cerezyme revenue guidance is being adjusted to $750 million — $1 billion from $1.250 billion — $1.275 billion.  The lower end of the guidance range reflects a scenario in which Genzyme would not be able to release any of the remaining work-in-process Cerezyme material that was unfinished when the plant was shut down; the higher end reflects a scenario in which the company is able to finish and release a significant portion of this material.  Genzyme has decided to discard the material from the end of the affected production run.  The company is conducting additional testing of the remaining material and continuing its discussions with regulatory authorities to determine whether the material may be finished and released, and if so, what portion of the material.

 

·      Fabrazyme revenue guidance is being adjusted to $510 million — $520 million from $560 million — $570 million to reflect product supply constraints due to the temporary halt in production at Allston.

 

·      Myozyme revenue guidance is being adjusted to $330 million — $340 million from $370 million — $380 million.  To provide more capacity in its Allston plant for Cerezyme and Fabrazyme, Genzyme has transitioned all Myozyme/Lumizyme production to its 4000 L Belgium facility, and is no longer manufacturing the product at the 2000 L scale.  FDA approval of the 4000 L process, which is now anticipated in the first quarter of 2010, will be necessary to expand supply and support an increase in U.S. sales.  Genzyme will begin to transition U.S. patients in the Myozyme Temporary Access Program from the product produced at the 2000 L scale to that produced at the 4000 L scale and will be providing 4000 L data to the FDA to support this transition.  The PDUFA date for Lumizyme (the 2000 L product) is November 14.  Upon approval, Genzyme will submit a supplemental BLA for the 4000 L process.  Genzyme anticipates a four-month FDA

 

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review of the sBLA, and if the FDA acts by the PDUFA date, a potential approval by the end of March 2010.

 

·      Genzyme’s gross margin guidance is being adjusted to a range of 72 — 73 percent of revenue from 75 percent.

 

·      Total 2009 revenue guidance is being adjusted to $4.6 billion — $5 billion from $5.15 billion — $5.35 billion.

 

·      GAAP EPS guidance is being adjusted to a range of $1.74 — $2.29 per diluted share from $3.02 per diluted share and non-GAAP EPS guidance is being adjusted to a range of $2.35 — $2.90 per diluted share from $3.52 per diluted share.  Non-GAAP EPS excludes the impact of stock compensation expenses and acquisition-related items.

 

Second-Quarter Results

 

Within the Genetic Disease segment, Myozyme revenue grew to $79.3 million, compared with $67.4 million in the first quarter of this year.  This reflects the re-acceleration of European sales following the February E.U. approval of production at the 4000 L scale, which expanded supply.  Second quarter sales of Myozyme were $77.2 million.

 

Genzyme has begun preparations to add a third 4000 L bioreactor to its Belgium facility to support the product’s growth over the longer-term.  The company anticipates this bioreactor will be approved for commercial production in mid-2011.

 

Cerezyme revenue was $298.1 million, compared with $319.4 million in the same period last year.  Revenue reflects both the impact of the temporary Allston shutdown as well as unfavorable currency exchange rates.

 

Genzyme is preparing to begin enrollment in two global, multi-center, phase 3 trials of Genz-112638, a potential new oral therapy for Gaucher disease type 1.  The first, a randomized, double-blind, placebo-controlled study, will include untreated Gaucher disease patients.  It is expected to enroll 36 patients who will be treated for 9 months.  The second trial will be a randomized conversion study involving patients who have previously received Cerezyme, with an anticipated enrollment of approximately 96 patients and a 9-month treatment period.  Genzyme is seeking to accelerate the regulatory process for this product globally in order to speed its approval.

 

Sales of Fabrazyme grew 6 percent, rising to $134.3 million from $126.6 million during the same period last year.  Including the $8.2 million impact of unfavorable currency exchange rates, revenue grew 13 percent.  Sales of Aldurazyme® (laronidase) were $39.2 million, compared with $38.8 million in the second quarter of 2008.

 

Construction continues on an additional manufacturing facility for Cerezyme and Fabrazyme in Framingham, Mass.  The plant is expected to be mechanically complete by the end of this year, and FDA approval for commercial production is anticipated in mid-2011.  This plant, which will include four 2000 L bioreactors, will provide substantial additional capacity to support the growth of the two products.  Genzyme has already hired approximately 100 people associated with the start-up of this facility.

 

Within the Biosurgery segment, sales of Synvisc® (hylan G-F 20) increased 16 percent to $82.4 million, from $70.9 million in last year’s second quarter.  This strong growth is being driven by the successful U.S. launch of Synvisc-One, which is exceeding expectations.  The product was launched in March and already represents more than half of all U.S. Synvisc business.  Synvisc-One is the only single-injection viscosupplement approved for the treatment of osteoarthritis knee pain in the United States.  By reducing the burden and cost of multiple injections, Synvsic-

 

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One is expanding the market for viscosupplementation products and extending the benefits of this therapeutic approach to a broader set of patients.

 

Within the Cardiometabolic and Renal segment, sales of Genzyme’s sevelamer therapies, Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride), were $175.4 million in the second quarter, compared with $168.6 million in the same period last year.

 

Genzyme has begun the launch of Renvela in Europe, following the product’s approval there last month.  The approval includes patients not on dialysis with serum phosphorus levels >1.78 mmol/L (5.5 mg/dL), and covers both the tablet and the powder formulations.  Genzyme launched Renvela tablets in the U.S. for dialysis patients last year, and the company expects FDA approval of the powder formulation for that indication this quarter.

 

Sales of Thyrogen® (thyrotropin alfa for injection) remained strong, increasing 9 percent to $42.9 million from $39.4 million, with growth driven by increased utilization of the treatment in thyroid remnant ablation procedures.

 

Revenue from the company’s Hematologic Oncology segment approximately doubled in the second quarter to $55.9 million, from $28.3 million in the same period last year.  This was driven by new revenue from Leukine® (sargramostim) and Fludara® (fludarabine), following the closing of the Bayer transaction at the end of May.  These products are enabling Genzyme to leverage and expand its existing oncology infrastructure to support a comprehensive portfolio of products for leukemia, bone marrow transplant and post-transplant complications.  This increased commercial presence will extend Genzyme’s reach into new markets and is expected to help accelerate the adoption of Clolar® (clofarabine) and Mozobil.

 

Second-quarter growth in this segment was also driven by the continued strong U.S. launch of Mozobil, which is being broadly adopted by transplant centers across the full continuum of stem cell mobilization, including the first-line setting.  Mozobil sales for the first half of 2009 are tracking to the company’s guidance of $40 — $50 million for the year.  In May the European Medicines Agency’s Committee for Human Medicinal Products adopted a positive opinion on the marketing authorization application for Mozobil, and a final decision from the European Commission is expected this quarter.  More than 1,000 patients in Europe have already been treated with Mozobil through a compassionate use program.

 

Other revenue grew 9 percent to $217.1 million from $199.8 million.  This segment includes the company’s Transplant, Genetics and Diagnostics businesses.  Genetics revenue increased 19 percent to $93.8 million from $78.5 million, driven by solid growth in reproductive and oncology testing services.  Within the Transplant business, sales of Thymoglobulin® (anti-thymocyte globulin, rabbit) were $53.6 million, a 19 percent increase over $45.2 million in the same period last year.  Construction is nearly complete on a new Thymoglobulin manufacturing facility in Lyon, France, which is intended to meet the anticipated long-term demand for the product, both for its current use and potential new indications.

 

Operating Expenses

 

Genzyme’s non-GAAP operating expenses (which include non-GAAP SG&A, R&D, and amortization) in the second quarter were $571 million, compared with $737 million (including the $175 million mipomersen licensing fee) in the second quarter of 2008.

 

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Development Programs

 

Genzyme’s pipeline includes several major late-stage programs with the potential to drive the company’s long-term growth:

 

·      Genzyme’s sNDA seeking approval of Clolar as a first-line therapy for adult acute myeloid leukemia is scheduled to be discussed at the September Oncologic Drugs Advisory Committee meeting, with FDA action expected this year.

 

·      Genzyme is making excellent progress in its development program for alemtuzumab, which has the potential to become a new standard of care in the treatment of multiple sclerosis.  Enrollment in the second of two phase 3 studies is progressing ahead of schedule due to strong physician and patient interest, and is now expected to be complete this quarter.  Results from both phase 3 studies are expected in 2011, and U.S. approval is anticipated in 2012.

 

·      Genzyme has completed enrollment in a pivotal trial of an advanced phosphate binder (APB) for patients with renal disease, and results are expected in the first quarter of next year.  The APB is designed to more effectively bind phosphate for a substantial improvement in potency while maintaining all the benefits of sevelamer.  The company anticipates that the APB would be approved by the time the core patent estate for sevelamer expires in 2014.

 

·      Genzyme and Isis Pharmaceuticals Inc. reported that the first phase 3 study of mipomersen, in patients with homozygous familial hypercholesterolemia (FH), met its primary endpoint.  Data from this study will form the basis of Genzyme’s initial regulatory filing for marketing approval, which is anticipated in the second half of 2010.     Enrollment was completed in the second phase 3 study of mipomersen, in patients with heterozygous FH, and results are anticipated in the first half of next year.

 

·      Genzyme and PTC Therapeutics Inc. are collaborating on ataluren, a novel oral therapy for the treatment of genetic disorders due to nonsense mutations.   A pivotal phase 2b trial of ataluren in Duchenne muscular dystrophy is fully enrolled and results are anticipated in the first half of next year.  A phase 3 trial in cystic fibrosis is expected to begin this quarter.

 

·      Genzyme and Osiris Therapeutics Inc. are in a collaboration to commercialize the adult stem cell treatment Prochymal.  Enrollment has been completed in the two phase 3 studies of Prochymal in graft vs. host disease and data are expected this 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 than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion.

 

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

 

5



 

focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.

 

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 203-369-1321.  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 July 29, 2009.

 

Upcoming Events

Genzyme will host a conference call on October 21 at 11:00 a.m. Eastern to discuss financial results for the third 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 203-369-0172.  This call will also be Webcast live on the investor events section of www.genzyme.com.  Replays of the call and the Webcast will be available until midnight on October 28, 2009.

 

This press release contains forward-looking statements regarding Genzyme’s financial outlook and business plans and strategies, including without limitation: its projected 2009 revenues for the company and for Cerezyme, Fabrazyme and Myozyme; its YE 2009 EPS guidance; its projected 2009 non-GAAP gross margin; its expectations regarding resumption of production at its Allston facility and the timing of producing new Cerezyme and Fabrazyme; its regulatory plans and expectations for approval of alglucosidase alfa produced using the 4000L scale process in the U.S., and the timing thereof; its plans to increase manufacturing capacity for Myozyme, Cerezyme and Fabrazyme and the timing thereof; its expectations regarding approval of a powder formulation of Renvela in the U.S.; its expectations for its Hematologic Oncology business, including adoption rates for Clolar and Mozobil and regulatory action on marketing applications for Mozobil in Europe and Clolar for adult AML patients in the U.S.; its expectations regarding the timing of receipt of clinical data and U.S. approval for alemtuzumab for MS; and its plans and estimated timetables for new and next-generation product clinical trials, filings or approvals, including for mipomersen, Genz-112638, Prochymal, ataluren, and APB. 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: that Genzyme is unable to resume normal production of Fabrazyme and Cerezyme in Allston by the end of July due to concerns from regulatory authorities regarding production at the facility, mechanical failures, additional contamination or any other reason; that the FDA and/or EMEA does not allow Genzyme to finish and release Cerezyme materials in progress at the time of the temporary shut-down; Genzyme’s ability to obtain and maintain regulatory approvals for products and manufacturing facilities, including for alglucosidase alfa produced at the 2000L and 4000L scales and for new manufacturing capacity, and the timing of receipt of such approvals; that Genzyme is unable to file for U.S. approval for the 4000L product within the expected timeframe due to a failure to obtain FDA agreement as to strategy or any other reason; 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; 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 successfully integrate the products and development program acquired from Bayer; Genzyme’s ability to maintain and enforce its intellectual property rights; Genzyme’s ability to successfully

 

6



 

identify and market to new patients; the availability and extent of reimbursement from third party payers; 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, 2009. 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®, Cerezyme®, Myozyme®, Mozobil®, Fabrazyme®, Aldurazyme®, Synvisc®, Renvela®, Renagel®, Thyrogen®, Clolar® and Thymoglobulin® are registered trademarks and Synvisc-One™ and Lumizyme™ are trademarks of Genzyme Corporation or its subsidiaries.  Fludara® and Leukine® are registered trademarks licensed to Genzyme Corporation.  Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.  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.

 

#     #     #

 

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GENZYME CORPORATION (GENZ)

 

Consolidated Statements of Operations

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

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

1,228,510

 

$

1,171,134

 

$

2,377,381

 

$

2,271,195

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of products and services sold

 

342,148

 

300,330

 

637,960

 

572,643

 

Selling, general and administrative

 

354,128

 

347,305

 

672,089

 

665,691

 

Research and development

 

210,522

 

381,861

 

417,447

 

644,658

 

Amortization of intangibles

 

63,945

 

55,605

 

121,543

 

111,263

 

Contingent consideration expense

 

9,090

 

 

9,090

 

 

Total operating costs and expenses

 

979,833

 

1,085,101

 

1,858,129

 

1,994,255

 

Operating income

 

248,677

 

86,033

 

519,252

 

276,940

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Gain (loss) on investments in equity securities, net

 

(105

)

9,153

 

(681

)

9,928

 

Gain on acquisition of business

 

20,975

 

 

20,975

 

 

Other

 

(2,056

)

582

 

(3,035

)

1,073

 

Investment income

 

4,144

 

13,352

 

9,494

 

28,222

 

Interest expense

 

 

(1,149

)

 

(2,804

)

Total other income (expenses)

 

22,958

 

21,938

 

26,753

 

36,419

 

Income before income taxes

 

271,635

 

107,971

 

546,005

 

313,359

 

Provision for income taxes

 

(79,402

)

(38,407

)

(158,286

)

(98,524

)

Net income

 

$

192,233

 

$

69,564

 

$

387,719

 

$

214,835

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.71

 

$

0.26

 

$

1.43

 

$

0.80

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

$

0.70

 

$

0.25

 

$

1.40

 

$

0.77

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

269,958

 

266,904

 

270,406

 

267,127

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

274,852

 

284,262

 

276,225

 

285,028

 

 


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, we believe that certain Non-GAAP financial measures, when considered together with the GAAP figures, can enhance the overall understanding of the company’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 filed as 8-K’s with the Securities and Exchange Commission at www.sec.gov.  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 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)          Prior to January 1, 2009, in accordance with EITF 04-8, the shares issuable upon conversion of our $690.0 million in principal of 1.25% convertible senior notes were included in diluted weighted average shares outstanding for purposes of computing diluted earnings per share, unless the effect was anti-dilutive.  Accordingly, interest and debt fees related to these notes of $1.9 million, net of tax, for the three months ended June 30, 2008, and $3.8 million, net of tax, for the six months ended June 30, 2008 have been added back to net income, and approximately 9.7 million shares issuable upon conversion of these notes, prior to redemption, have been included in diluted weighted average shares outstanding.  There are no similar adjustments to the computation of diluted earnings per share for the three and six months ended June 30, 2009, because the notes were redeemed, primarily for cash, on December 1, 2008.

 

GENZYME CORPORATION (GENZ)

 

Condensed Consolidated Balance Sheets

(Unaudited, amounts in thousands)

 

 

 

June 30,

 

December 31,

 

 

 

2009

 

2008

 

Cash and all marketable securities

 

$

1,049,383

 

$

973,691

 

Other current assets

 

2,135,253

 

1,886,522

 

Property, plant and equipment, net

 

2,550,269

 

2,306,567

 

Intangibles, net

 

3,837,013

 

3,055,772

 

Other noncurrent assets

 

529,413

 

448,724

 

Total assets

 

$

10,101,331

 

$

8,671,276

 

 

 

 

 

 

 

Current liabilities

 

$

1,117,587

 

$

914,283

 

Noncurrent liabilities

 

1,198,616

 

451,000

 

Stockholders’ equity

 

7,785,128

 

7,305,993

 

Total liabilities and stockholders’ equity

 

$

10,101,331

 

$

8,671,276

 

 



 

Genzyme Corporation (GENZ)

Analyst Schedule

(Unaudited, amounts in thousands, except percentage amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

Q2-09

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Q2-08

 

 

 

 

 

 

 

 

 

Q2-08

 

Q3-08

 

Q4-08

 

Q1-09

 

Q2-09

 

% B/(W)

 

FY 2007

 

FY 2008

 

YTD 06/30/09

 

Total revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic Diseases

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cerezyme

 

$

319,360

 

$

309,280

 

$

306,034

 

$

295,970

 

$

298,087

 

(7

)%

$

1,133,153

 

$

1,238,977

 

$

594,057

 

Fabrazyme

 

126,608

 

125,619

 

125,558

 

122,201

 

134,302

 

6

%

424,284

 

494,260

 

256,503

 

Myozyme

 

77,222

 

76,663

 

74,967

 

67,392

 

79,273

 

3

%

200,728

 

296,176

 

146,665

 

Aldurazyme

 

38,834

 

38,236

 

37,579

 

36,837

 

39,190

 

1

%

 

151,664

 

76,027

 

Other Genetic Diseases

 

10,437

 

11,367

 

14,039

 

14,650

 

17,301

 

66

%

8,314

 

45,615

 

31,951

 

Total Genetic Diseases product and service revenue

 

572,461

 

561,165

 

558,177

 

537,050

 

568,153

 

(1

)%

1,766,479

 

2,226,692

 

1,105,203

 

R&D Revenue

 

 

 

 

 

 

 

 

1,059

 

 

 

Total Genetic Diseases

 

572,461

 

561,165

 

558,177

 

537,050

 

568,153

 

(1

)%

1,767,538

 

2,226,692

 

1,105,203

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiometabolic and Renal

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renagel and Renvela (including Sevelamer)

 

168,567

 

170,992

 

169,476

 

170,599

 

175,398

 

4

%

602,670

 

677,729

 

345,997

 

Hectorol

 

30,852

 

33,825

 

34,400

 

33,030

 

28,981

 

(6

)%

115,708

 

128,153

 

62,011

 

Subtotal

 

199,419

 

204,817

 

203,876

 

203,629

 

204,379

 

2

%

718,378

 

805,882

 

408,008

 

Thyrogen

 

39,448

 

38,153

 

37,062

 

38,826

 

42,860

 

9

%

113,587

 

148,448

 

81,686

 

Other Cardiometabolic and Renal

 

333

 

573

 

496

 

494

 

753

 

126

%

103

 

1,653

 

1,247

 

Total Cardiometabolic and Renal product and service revenue

 

239,200

 

243,543

 

241,434

 

242,949

 

247,992

 

4

%

832,068

 

955,983

 

490,941

 

R&D revenue

 

85

 

56

 

27

 

13

 

8

 

(91

)%

1,200

 

200

 

21

 

Total Cardiometabolic and Renal

 

239,285

 

243,599

 

241,461

 

242,962

 

248,000

 

4

%

833,268

 

956,183

 

490,962

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Biosurgery

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Synvisc

 

70,927

 

67,513

 

68,512

 

63,171

 

82,417

 

16

%

242,319

 

263,094

 

145,588

 

Sepra products

 

34,780

 

33,001

 

35,278

 

34,304

 

36,038

 

4

%

104,318

 

133,663

 

70,342

 

Other Biosurgery

 

24,690

 

21,787

 

20,908

 

21,485

 

20,002

 

(19

)%

74,673

 

91,698

 

41,487

 

Total Biosurgery product and service revenue

 

130,397

 

122,301

 

124,698

 

118,960

 

138,457

 

6

%

421,310

 

488,455

 

257,417

 

R&D revenue

 

818

 

661

 

563

 

562

 

870

 

6

%

5,337

 

2,645

 

1,432

 

Total Biosurgery

 

131,215

 

122,962

 

125,261

 

119,522

 

139,327

 

6

%

426,647

 

491,100

 

258,849

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hematologic Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Hematologic Oncology product and service revenue

 

26,443

 

26,328

 

27,437

 

34,423

 

55,078

 

108

%

69,927

 

102,899

 

89,501

 

R&D revenue

 

1,903

 

2,292

 

9,055

 

1,484

 

852

 

(55

)%

7,006

 

14,439

 

2,336

 

Total Hematologic Oncology

 

28,346

 

28,620

 

36,492

 

35,907

 

55,930

 

97

%

76,933

 

117,338

 

91,837

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic/Diagnostics product and service revenue

 

116,863

 

121,163

 

124,840

 

129,194

 

132,955

 

14

%

410,917

 

477,614

 

262,149

 

Transplant product and service revenue

 

47,763

 

47,784

 

50,723

 

52,666

 

56,060

 

17

%

174,826

 

192,200

 

108,726

 

Other product and service revenue

 

29,296

 

28,598

 

30,252

 

23,501

 

22,423

 

(23

)%

108,577

 

119,155

 

45,924

 

Total Other product and service revenue

 

193,922

 

197,545

 

205,815

 

205,361

 

211,438

 

9

%

694,320

 

788,969

 

416,799

 

R&D revenue

 

5,905

 

6,393

 

6,354

 

8,069

 

5,662

 

(4

)%

14,813

 

24,757

 

13,731

 

Total Other

 

199,827

 

203,938

 

212,169

 

213,430

 

217,100

 

9

%

709,133

 

813,726

 

430,530

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

1,171,134

 

$

1,160,284

 

$

1,173,560

 

$

1,148,871

 

$

1,228,510

 

5

%

$

3,813,519

 

$

4,605,039

 

$

2,377,381

 

 

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 AND CASH GENERATED

For the Three Months Ended June 30, 2009

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bayer Acquisition Related

 

 

 

 

 

 

 

OTHER DISCRETE ITEMS

 

 

 

 

 

 

 

Contingent

 

Gain on

 

 

 

 

 

 

 

(included in GAAP and Non-GAAP results)

 

 

 

GAAP

 

Consideration

 

Acquisition

 

FAS 123R

 

 

 

 

 

Allston

 

Inventory

 

 

 

As Reported

 

Expense

 

of Business

 

Expense

 

NON-GAAP (1)

 

Remediation

 

Fair Value Step-up

 

Income Statement Classification:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

 

 

$

1,228,510

 

 

 

 

 

 

 

 

 

$

1,228,510

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of products and services sold

 

 

 

$

(342,148

)

 

 

 

 

$

7,570

 

 

 

$

(334,578

)

$

14,197

 

$

6,639

 

Gross margin

 

72

%

$

886,362

 

$

 

$

 

$

7,570

 

73

%

$

893,932

 

$

14,197

 

$

6,639

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

 

$

(354,128

)

 

 

 

 

$

37,817

 

 

 

$

(316,311

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

$

(210,522

)

 

 

 

 

$

19,780

 

 

 

$

(190,742

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangibles

 

 

 

$

(63,945

)

 

 

 

 

 

 

 

 

$

(63,945

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration expense

 

 

 

$

(9,090

)

$

9,090

 

 

 

 

 

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gains (losses) on investments in equity securities

 

 

 

$

(105

)

 

 

 

 

 

 

 

 

$

(105

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain on acquisition of business

 

 

 

$

20,975

 

 

 

$

(20,975

)

 

 

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

$

(2,056

)

 

 

 

 

 

 

 

 

$

(2,056

)

$

1,484

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

 

 

$

4,144

 

 

 

 

 

 

 

 

 

$

4,144

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

 

$

271,635

 

$

9,090

 

$

(20,975

)

$

65,167

 

 

 

$

324,917

 

$

15,681

 

$

6,639

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Provision for) benefit from income taxes

 

29.23

%

$

(79,402

)

$

(2,463

)

$

5,683

 

$

(16,198

)

28.43

%

$

(92,380

)

$

(5,665

)

$

(1,298

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

 

 

$

192,233

 

$

6,627

 

$

(15,292

)

$

48,969

 

 

 

$

232,537

 

$

10,016

 

$

5,341

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

$

0.71

 

$

0.02

 

$

(0.06

)

$

0.18

 

 

 

$

0.86

 

$

0.04

 

$

0.02

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted

 

 

 

$

0.70

 

$

0.02

 

$

(0.06

)

$

0.18

 

 

 

$

0.85

 

$

0.04

 

$

0.02

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

269,958

 

269,958

 

269,958

 

269,958

 

 

 

269,958

 

269,958

 

269,958

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted

 

 

 

274,852

 

274,852

 

274,852

 

274,852

 

 

 

274,852

 

274,852

 

274,852

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Net Income

 

 

 

$

232,537

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation, net of tax

 

 

 

29,144

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from the issuance of common stock

 

 

 

18,982

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Cash Generated

 

 

 

$

280,663

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Notes:

 

(1) Represents the Non-GAAP results of operations for Genzyme Corporation for the three months ended June 30, 2009.  We believe that certain Non-GAAP financial measures, when considered together with the GAAP figures, can enhance the overall understanding of the company’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 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.  Earnings per share are calculated as net income (loss) divided by weighted average shares outstanding.  Therefore, earnings per share may not add across due to rounding.

 



 

GENZYME 2009 GUIDANCE - NON-GAAP REVISED TO REFLECT ALLSTON MANUFACTURING PLANT INTERRUPTION

 

 

 

7.22.09 Guidance

 

5.6.09 Guidance

 

DESCRIPTION

 

Ranges

 

Ranges

 

Genetic Diseases

 

$

1,815

 

$

2,100

 

$

2,405

 

$

2,465

 

 

 

 

 

 

 

 

 

 

 

Cardiometabolic and Renal

 

1,035

 

1,065

 

1,035

 

1,065

 

 

 

 

 

 

 

 

 

 

 

Biosurgery

 

540

 

570

 

540

 

570

 

 

 

 

 

 

 

 

 

 

 

Hematologic Oncology

 

370

 

395

 

370

 

395

 

 

 

 

 

 

 

 

 

 

 

Other

 

835

 

890

 

835

 

890

 

TOTAL REVENUE

 

$

4,600

 

$

5,000

 

$

5,150

 

$

5,350

 

 

 

 

 

 

 

 

 

 

 

*GROSS MARGIN

 

72

%

73

%

approx.

 

75

%

 

 

 

 

 

 

 

 

 

 

*SG&A

 

28

%

27

%

approx.

 

26

%

*R&D

 

18

%

17

%

approx.

 

16

%

Amortization

 

approx.

 

(275

)

approx.

 

(275

)

Net Interest / Other

 

approx.

 

30

 

approx.

 

30

 

 

 

 

 

 

 

 

 

 

 

TAX RATE - GAAP

 

31

%

30

%

approx.

 

30

%

*TAX RATE - NON-GAAP

 

30

%

29

%

approx.

 

29

%

 

 

 

 

 

 

 

 

 

 

GAAP EPS

 

1.74

 

2.29

 

approx.

 

3.02

 

FAS141R ACQUISITION RELATED:

 

 

 

 

 

 

 

 

 

- Contingent Consideration Expense

 

0.17

 

0.17

 

approx.

 

0.00

 

- (Gain)/Loss on Acquisition of a Business

 

(0.06

)

(0.06

)

approx.

 

0.00

 

FAS123R - Stock Compensation

 

0.50

 

0.50

 

approx.

 

0.50

 

*NON-GAAP EPS

 

$

2.35

 

$

2.90

 

 

 

$

3.52

 

 

 

 

 

 

 

 

 

 

 

WTD AVERAGE DILUTED SHARES O/S

 

280

 

282

 

280

 

282

 

 

 

 

 

 

 

 

 

 

 

CAPITAL EXPENDITURES

 

$

600

 

$

650

 

$

600

 

$

650

 

 

This financial guidance, which is provided as part of a press release dated July 22, 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 significant acquisition related and FAS123R expenses.

 

 

 

7.22.09 Ranges

 

5.6.09 Ranges

 

SELECT PRODUCT GUIDANCE:

 

 

 

 

 

 

 

 

 

Cerezyme

 

$

750

 

$

1,000

 

$

1,250

 

$

1,275

 

Fabrazyme

 

510

 

520

 

560

 

570

 

Myozyme

 

330

 

340

 

370

 

380

 

Mozobil

 

40

 

50

 

40

 

50

 

Renagel/Renvela

 

725

 

735

 

725

 

735