EX-99.1 2 a09-31698_2ex99d1.htm EX-99.1

Exhibit 99.1

 

 

For Immediate Release

 

Media Contact:

 

Investor Contact:

October 21, 2009

 

Erin Emlock

 

Patrick Flanigan

 

 

(617) 768-6923

 

(617) 768-6563

 

Genzyme Reports Third-Quarter Financial Results

 


 

Progress Continues at Allston Manufacturing Facility

 

CAMBRIDGE, Mass. — Genzyme Corp. (NASDAQ: GENZ) today reported that third-quarter revenue was $1.06 billion, compared with $1.16 billion in the same period a year ago.  Results reflect the impact of the temporary interruption in production of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) associated with the remediation of the company’s Allston manufacturing facility.

 

GAAP net income was $16.0 million, or $0.06 per diluted share, compared with $119.6 million, or $0.42 per diluted share, in the third quarter of 2008.  Non-GAAP net income was $83.9 million, or $0.31 per diluted share, compared with $151.4 million, or $0.53 per diluted share, in the same period last year.  Non-GAAP net income excludes purchase accounting and inventory step-up associated with the acquisition of Bayer oncology assets, and stock compensation.

 

GAAP and non-GAAP net income in this year’s third quarter reflect the $23.7 million pre-tax cost of the temporary Allston shutdown and related remediation costs.  Net income also includes the $7.0 million pre-tax impact of a payment to acquire technology from Targeted Genetics.  These expenses, along with lost Cerezyme/Fabrazyme revenue and a shift in product mix, reduced the gross margin to approximately 67 percent of revenue during the third quarter.

 

The company expects its 2009 non-GAAP EPS to be approximately $2.26, compared with previous guidance of $2.35 — $2.90.  This reflects the decision to write off Cerezyme work-in-process material, the cost of remediating the Allston plant, and management of customer-level inventories related to the Bayer transaction.

 

Genzyme generated approximately $363 million in cash from operations during the third quarter.  The company continues to reinvest cash to expand its manufacturing infrastructure and repurchase shares to offset dilution.  During the third quarter, Genzyme repurchased 5.5 million shares for $307 million.  To date this year, the company has repurchased 7.5 million shares for $414 million, and is on track to reacquire a total of 20 million shares by May 2010, in-line with the goals of its existing three-year stock buyback program.  Currently Genzyme has 274 million diluted shares outstanding.

 

“During the next 12 months, we will invest in our existing business and pipeline, while making changes to become stronger and build for our future,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer.  “In particular, we will concentrate on recapturing momentum in our genetic disease business, where we will commit the resources to provide the highest level of service and support to patients and physicians.”

 



 

Recovery of the Allston Plant

 

Genzyme has successfully re-started all six bioreactors at Allston for the production of Cerezyme and Fabrazyme.  The company this month began filling vials of newly produced Cerezyme and anticipates that the product will be available for shipment starting at the end of November.  Genzyme has completed the first production cycles for Fabrazyme, is preparing to begin the next, and anticipates that the first shipments of new Fabrazyme will take place in late-December.  The company expects that it will be able to fully meet anticipated demand for these therapies in the first quarter of 2010.

 

The current limited inventory of both products is being distributed through conservation programs to help ensure that the most vulnerable patients continue to receive treatment.  Clinical guidelines developed by expert physicians, patient group leaders and regulators are in place globally to help support doctors and patients in their decisions about product usage during this period.

 

As part of its efforts to strengthen its manufacturing operations, Genzyme has appointed a new site leader at the Allston plant, is recruiting additional executives to oversee manufacturing and quality control, and has hired third-party quality assurance and compliance experts to review Genzyme’s operations.

 

In addition, construction continues on a new manufacturing facility for Cerezyme and Fabrazyme in Framingham, Mass.  The plant is expected to be mechanically complete with all cell culture and bioreactor suites installed by the end of this year, and the first engineering runs for Fabrazyme are planned for the first half of 2010.  The first FDA approval for commercial production at the plant is anticipated in 2011 for Fabrazyme, with Cerezyme to follow.  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 more than 100 people associated with the start-up of this facility.

 

Lumizyme Progress

 

Genzyme is also expanding manufacturing capacity for Myozyme® (alglucosidase alfa) / Lumizyme™ (alglucosidase alfa).  The company has transitioned all production to its Geel, Belgium facility, where it is adding a third 4000 L bioreactor.  Upon EMEA and FDA approvals of this bioreactor, the company will have the capacity to provide treatment for approximately 3,000 patients.  Genzyme is actively seeking to acquire additional manufacturing capacity for Myozyme to support the longer-term growth of this product.

 

With the completion of the current projects in Belgium and Framingham, Genzyme will have more than quadrupled its biologics manufacturing capacity since 2004.  The company is investing more than $1 billion to expand the Allston and Belgium facilities and to construct the new Framingham plant.

 

Genzyme has received FDA clearance 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.  The PDUFA date for Lumizyme (the 2000 L product) is November 14.  Upon approval, Genzyme plans to submit a supplemental BLA for the 4000 L process.  A standard review period is four months, which would mean an FDA action date by the end of March 2010.  An FDA approval would enable widespread access to the treatment for U.S. patients.

 

2



 

Third-Quarter Results and Pipeline Updates

 

Genetic Disease

 

Within this segment, Myozyme revenue grew to $86.0 million, compared with $76.7 million in the third quarter of 2008.  European sales are continuing to re-accelerate this year following the first-quarter E.U. approval of production at the 4000 L scale, which expanded supply.  Second-quarter sales were $79.3 million.

 

Cerezyme revenue was $93.6 million, compared with $309.3 million in the same period last year, and Fabrazyme sales were $115.2 million compared with $125.6 million last year.  Revenue for both products reflects the impact of the temporary interruption in production due to the Allston remediation.  Third-quarter sales of Aldurazyme® (laronidase) were $40.3 million, compared with $38.2 million in the third quarter of 2008.

 

Genzyme has begun enrollment in the first of two global, multi-center, phase 3 trials of Genz-112638, a potential new oral therapy for Gaucher disease type 1.  Genzyme is accelerating this development program in an effort to bring this potential therapy to patients as quickly as possible.  Currently over 35 centers in more than 20 countries are participating in these trials, and the company expects that the number of recruiting centers will continue to increase, as more sites receive regulatory approval.

 

Genzyme is collaborating with PTC Therapeutics Inc. 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 recently began enrolling patients.

 

Biosurgery

 

Within the Biosurgery segment, sales of Synvisc® (hylan G-F 20) increased 30 percent to $87.5 million, from $67.5 million in last year’s third quarter.  This strong growth is being driven by the successful U.S. launch of Synvisc-One® (hylan G-F 20), which is exceeding expectations.  The product was launched in March and now represents more than 50 percent 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, and its launch has significantly improved Genzyme’s market share and competitive position.  By reducing the burden and cost of multiple injections, Synvisc-One is expanding the market for viscosupplementation products and extending the benefits of this therapeutic approach to a broader set of patients.

 

Sales of Sepra® products grew 15 percent to $37.8 million, from $33 million in the third quarter of 2008, with growth driven by increasing use of the Seprafilm® adhesion barrier in C-section and other gynecologic procedures.

 

3



 

Cardiometabolic and Renal

 

Within this segment, sales of Genzyme’s sevelamer therapies, Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride), were $181.7 million in the third quarter, compared with $171.0 million in the same period last year.

 

Genzyme has begun the launch of Renvela in Europe, following the product’s approval there in June.  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 for dialysis patients in the U.S. last year, received FDA approval of the powder formulation for that indication during the third quarter, and plans to launch the new formulation next month.

 

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.

 

Sales of Thyrogen® (thyrotropin alfa for injection) were $41.7 million compared with $38.2 million during the third quarter of 2008.

 

The first phase 3 study of mipomersen, in patients with homozygous familial hypercholesterolemia (FH), met its primary endpoint and full results will be presented at the American Heart Association meeting next month.  Enrollment is complete in the second phase 3 study of mipomersen, in patients with heterozygous FH, and results are anticipated during the first half of next year.  Genzyme is collaborating with Isis Pharmaceuticals Inc. on the development of this treatment.

 

Hematologic Oncology

 

Revenue from the company’s Hematologic Oncology segment more than doubled to $88.0 million, from $34.1 million in the same period last year.  This increase was driven by new revenue from Leukine® (sargramostim), Campath® (alemtuzumab) and Fludara® (fludarabine phosphate), following the closing of the transaction with Bayer at the end of May.  Revenue, however, was lower than expected as the company worked this quarter to manage inventories, integrate these products into its business across several new geographies, and hire and train new personnel to support the expanded business.  Genzyme expects these activities to continue throughout the fourth quarter.

 

Third-quarter growth in this segment was also driven by Clolar® (clofarabine injection) and Mozobil® (plerixafor injection).  Mozobil was launched in Europe following approval there in August.  Genzyme is also making excellent progress in the ongoing U.S. launch of the product, and sales for the first three quarters of 2009 are tracking to the company’s guidance of $40 — $50 million for the year.

 

Genzyme has requested a meeting with the FDA to discuss a path forward for the potential use of Clolar in adult patients with acute myeloid leukemia, following the receipt of a complete response letter regarding the company’s sNDA this month.  The agency has recommended that a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.  Genzyme is conducting a randomized, placebo-controlled phase 3 trial comparing Clolar in combination with cytarabine to cytarabine alone in relapsed and refractory adult AML

 

4



 

patients.  The trial continues to exceed patient accrual expectations, and results are expected in 2011.

 

At the December American Society of Hematology meeting there will be 12 oral presentations on Genzyme’s hematologic oncology products, including new data on expanded indications in development for Mozobil, Clolar and Campath with the potential to drive future growth.  Data will be presented from a phase 3 trial of Campath’s use in combination with Fludara in relapsed or refractory chronic lymphocytic leukemia patients, which recently met its primary endpoint.  There will be presentations on Clolar’s use in AML, non-Hodgkins lymphoma, myelodysplastic syndromes and as a conditioning regimen for bone marrow transplantation.  Mozobil pharmacoeconomic data, as well as data on the product’s development for use in chemosensitization, will also be presented.

 

Genzyme’s alemtuzumab for multiple sclerosis showed a durable treatment benefit in a review of four-year phase 2 trial data, which was presented at the ECTRIMS annual meeting last month.  Enrollment has been completed ahead of schedule in both phase 3 studies of the product, with results expected in 2011 and U.S. approval anticipated in 2012.

 

Other Revenue — Transplant, Genetics and Diagnostics

 

Other revenue, which includes the company’s Transplant, Genetics and Diagnostics businesses, was $208.4 million compared to $198.5 million during the third quarter of 2008.

 

Genetics revenue increased 12 percent to $91.9 million from $82.1 million in the same period last year, driven by volume increases from new and existing clients in the reproductive and oncology businesses.

 

Within the Transplant business, sales of Thymoglobulin® (anti-thymocyte globulin, rabbit) were $55.6 million, a 16 percent increase over $47.8 million in last year’s third quarter, driven by continued geographic expansion.  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.  Pending regulatory authority approval, commercial production is anticipated to begin at the site next year.  Genzyme continues to explore expanded uses for Thymoglobulin, including in Type 1 diabetes, where it is conducting a phase 2 trial in conjunction with the Immune Tolerance Network.

 

Operating Expenses

 

Genzyme’s non-GAAP operating expenses (which include non-GAAP SG&A, R&D, and amortization) in the third quarter were $619.2 million, compared with $652.8 million in the third quarter of 2008.  GAAP operating expenses were $657.9 million compared with $691.7 million in the same period last year.  GAAP and non-GAAP operating expenses for the third quarter of 2008 included a $100 million licensing fee to PTC for ataluren.

 

Developing New Markets

 

During the third quarter, Genzyme broke ground on a new R&D facility in Beijing.  The initiative is a key element in Genzyme’s ongoing global expansion and commitment to establishing a long-term presence in this important market.  Genzyme currently has offices in Beijing and Shanghai, and markets Synvisc, Thymoglobulin and Fludara in China.  In addition, Genzyme is building its presence in India, and this year launched Renvela and Synvisc-One there. 

 

5



 

Genzyme also markets Thymoglobulin and Thyrogen in the country, has a commercial office in New Delhi, and is engaged in clinical development work.

 

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 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 203-369-0172.  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.

 

Upcoming Events

Genzyme will host a conference call on February 17, 2010 at 11:00 a.m. Eastern to discuss financial results for the fourth quarter of 2009, and 2010 guidance.  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 203-369-0261.  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 24, 2010.

 

This press release contains forward-looking statements regarding Genzyme’s financial outlook and business plans and strategies, including without limitation: its Q4 and YE 2009 non-GAAP EPS guidance; its expectations regarding the timing of shipments of newly-produced Cerezyme and Fabrazyme and when the company anticipates being able to meet full demand for these products; its regulatory plans, timetables and expectations for approval of alglucosidase alfa produced using the 2000L scale process by the FDA, the 4000L scale process by the FDA, and the additional 4000L bioreactor by the EMEA and the FDA; its plans to increase manufacturing capacity for Cerezyme, Fabrazyme, Myozyme and Thymoglobulin, including expectations regarding the timing of receipt of regulatory approvals of the new facilities and the effect the additional capacity in Framingham, Geel and Lyon will have on Genzyme’s ability to meet anticipated demand for these products; its expectations regarding the timing of receipt of clinical data and U.S. approval for alemtuzumab for MS; its plans and estimated timetables for new and next-generation product clinical trials, filings and regulatory approvals, including for Genz-112638, APB, mipomersen, and ataluren; its plans to drive future growth of Mozobil, Clolar and Campath by developing expanded indications for these products; its strategy for moving forward on Clolar in AML and the expected timing of receipt of clinical trial results; its sales expectations for oncology products; and its plans to launch the powder formulation of Renvela in the U.S and the timing thereof. These statements are subject to risks and uncertainties that could cause

 

6



 

actual results to differ materially from those forecasted. These risks and uncertainties include, among others that: Genzyme encounters additional manufacturing problems due to mechanical failures, viral or bacterial contamination, or any other reason; Genzyme encounters further supply problems due to low product yields, or a determination by a regulatory authority that product produced at its Allston facility or any other facility cannot be released; Genzyme is unable to obtain and/or maintain regulatory approvals for its products, manufacturing processes and manufacturing facilities, including securing FDA approval for alglucosidase alfa produced at the 2000L scale in Allston and the 4000L scale in Geel on expected timeframes or at all; Genzyme is unable to file for U.S. approval for the alglucosidase alfa produced using the 4000L process within the expected timeframe due to a failure to obtain FDA approval of the product manufactured using the 2000L process, failure to secure agreement as to strategy, including its decision to file a sBLA to the 4000L BLA, or any other reason; Genzyme and its collaboration partners are unable to successfully complete clinical development of new products, including Genz-112638, mipomersen and ataluren, at all or on expected timeframes; Genzyme is unable to expand the use of current and next-generation products in existing and new indications, including Synvisc-ONE, Mozobil, alemtuzumab-MS, APB, Clolar and Campath; Genzyme is unable to manufacture its products and product candidates in a timely and cost effective manner and in sufficient quantities to meet demand; Genzyme’s integration of products and development programs acquired from Bayer is more costly or time-consuming than forecasted; Genzyme is unable to maintain and enforce its intellectual property rights; Genzyme is unsuccessful in identifying and marketing to new patients; the availability and extent of reimbursement from third party payers is restrained; and the risks and uncertainties described in Genzyme’s SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption “Risk Factors” in Genzyme’s Quarterly Report on Form 10-Q for the period ended June 30, 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®, Fabrazyme®, Myozyme®, Synvisc®, Synvisc-One®, Sepra®, Seprafilm®, Renvela®, Renagel®, Thyrogen®, Mozobil®, Clolar®, Campath® and Thymoglobulin® are registered trademarks and Lumizyme™ is a trademark 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.  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.

 

#     #     #

 

7



 

GENZYME CORPORATION (GENZ)

 

Consolidated Statements of Operations

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

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

1,057,514

 

$

1,160,284

 

$

3,434,895

 

$

3,431,479

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of products and services sold

 

359,407

 

285,208

 

1,005,742

 

857,851

 

Selling, general and administrative

 

367,347

 

331,170

 

1,039,436

 

996,861

 

Research and development

 

219,275

 

305,242

 

636,722

 

949,900

 

Amortization of intangibles

 

71,280

 

55,295

 

192,823

 

166,558

 

Contingent consideration expense

 

28,197

 

 

37,287

 

 

Total operating costs and expenses

 

1,045,506

 

976,915

 

2,912,010

 

2,971,170

 

Operating income

 

12,008

 

183,369

 

522,885

 

460,309

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Gain (loss) on investments in equity securities, net

 

(651

)

(14,129

)

(1,332

)

(4,201

)

Gain on acquisition of business

 

 

 

24,159

 

 

Other

 

616

 

(133

)

(2,419

)

940

 

Investment income

 

4,544

 

11,793

 

14,038

 

40,015

 

Interest expense

 

 

(792

)

 

(3,596

)

Total other income (expenses)

 

4,509

 

(3,261

)

34,446

 

33,158

 

Income before income taxes

 

16,517

 

180,108

 

557,331

 

493,467

 

Provision for income taxes

 

(522

)

(60,512

)

(158,276

)

(159,036

)

Net income

 

$

15,995

 

$

119,596

 

$

399,055

 

$

334,431

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.06

 

$

0.44

 

$

1.48

 

$

1.25

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

$

0.06

 

$

0.42

 

$

1.45

 

$

1.19

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

268,957

 

269,176

 

269,923

 

267,767

 

 

 

 

 

 

 

 

 

 

 

Diluted (1)

 

273,741

 

288,179

 

275,375

 

286,003

 

 


 

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 September 30, 2008, and $5.7 million, net of tax, for the nine months ended September 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 nine months ended September 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)

 

 

 

September 30,

 

December 31,

 

 

 

2009

 

2008

 

 

 

 

 

 

 

Cash and all marketable securities

 

$

988,872

 

$

973,691

 

Other current assets

 

1,947,836

 

1,886,522

 

Property, plant and equipment, net

 

2,695,231

 

2,306,567

 

Intangibles, net

 

3,779,951

 

3,055,772

 

Other noncurrent assets

 

559,001

 

448,724

 

Total assets

 

$

9,970,891

 

$

8,671,276

 

 

 

 

 

 

 

Current liabilities

 

$

1,097,440

 

$

914,283

 

Noncurrent liabilities

 

1,258,120

 

451,000

 

Stockholders’ equity

 

7,615,331

 

7,305,993

 

Total liabilities and stockholders’ equity

 

$

9,970,891

 

$

8,671,276

 

 



 

Genzyme Corporation (GENZ)

Analyst Schedule

(Unaudited, amounts in thousands, except percentage amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

Q3-09

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Q3-08

 

 

 

 

 

 

 

 

 

Q3-08

 

Q4-08

 

Q1-09

 

Q2-09

 

Q3-09

 

% B/(W)

 

FY 2007

 

FY 2008

 

YTD 09/30/09

 

Total revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic Diseases

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cerezyme

 

$

309,280

 

$

306,034

 

$

295,970

 

$

298,087

 

$

93,599

 

(70

)%

$

1,133,153

 

$

1,238,977

 

$

687,656

 

Fabrazyme

 

125,619

 

125,558

 

122,201

 

134,302

 

115,161

 

(8

)%

424,284

 

494,260

 

371,664

 

Myozyme

 

76,663

 

74,967

 

67,392

 

79,273

 

85,980

 

12

%

200,728

 

296,176

 

232,645

 

Aldurazyme

 

38,236

 

37,579

 

36,837

 

39,190

 

40,331

 

5

%

 

151,664

 

116,358

 

Other Genetic Diseases

 

11,367

 

14,039

 

14,650

 

17,301

 

19,217

 

69

%

8,314

 

45,615

 

51,168

 

Total Genetic Diseases product and service revenue

 

561,165

 

558,177

 

537,050

 

568,153

 

354,288

 

(37

)%

1,766,479

 

2,226,692

 

1,459,491

 

R&D Revenue

 

 

 

 

 

 

 

 

1,059

 

 

 

Total Genetic Diseases

 

561,165

 

558,177

 

537,050

 

568,153

 

354,288

 

(37

)%

1,767,538

 

2,226,692

 

1,459,491

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiometabolic and Renal

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renagel and Renvela (including Sevelamer)

 

170,992

 

169,476

 

170,599

 

175,398

 

181,702

 

6

%

602,670

 

677,729

 

527,699

 

Hectorol

 

33,825

 

34,400

 

33,030

 

28,981

 

36,869

 

9

%

115,708

 

128,153

 

98,880

 

Subtotal

 

204,817

 

203,876

 

203,629

 

204,379

 

218,571

 

7

%

718,378

 

805,882

 

626,579

 

Thyrogen

 

38,153

 

37,062

 

38,826

 

42,860

 

41,691

 

9

%

113,587

 

148,448

 

123,377

 

Other Cardiometabolic and Renal

 

573

 

496

 

494

 

753

 

742

 

29

%

103

 

1,653

 

1,989

 

Total Cardiometabolic and Renal product and service revenue

 

243,543

 

241,434

 

242,949

 

247,992

 

261,004

 

7

%

832,068

 

955,983

 

751,945

 

R&D revenue

 

56

 

27

 

13

 

8

 

156

 

179

%

1,200

 

200

 

177

 

Total Cardiometabolic and Renal

 

243,599

 

241,461

 

242,962

 

248,000

 

261,160

 

7

%

833,268

 

956,183

 

752,122

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Biosurgery

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Synvisc

 

67,513

 

68,512

 

63,171

 

82,417

 

87,526

 

30

%

242,319

 

263,094

 

233,114

 

Sepra products

 

33,001

 

35,278

 

34,304

 

36,038

 

37,831

 

15

%

104,318

 

133,663

 

108,173

 

Other Biosurgery

 

21,787

 

20,908

 

21,485

 

20,002

 

19,643

 

(10

)%

74,673

 

91,698

 

61,130

 

Total Biosurgery product and service revenue

 

122,301

 

124,698

 

118,960

 

138,457

 

145,000

 

19

%

421,310

 

488,455

 

402,417

 

R&D revenue

 

661

 

563

 

562

 

870

 

647

 

(2

)%

5,337

 

2,645

 

2,079

 

Total Biosurgery

 

122,962

 

125,261

 

119,522

 

139,327

 

145,647

 

18

%

426,647

 

491,100

 

404,496

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hematologic Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Hematologic Oncology product and service revenue

 

26,328

 

27,437

 

34,423

 

55,078

 

87,982

 

234

%

69,927

 

102,899

 

177,483

 

R&D revenue

 

7,726

 

15,104

 

8,775

 

5,918

 

7

 

(100

)%

18,601

 

36,148

 

14,700

 

Total Hematologic Oncology

 

34,054

 

42,541

 

43,198

 

60,996

 

87,989

 

158

%

88,528

 

139,047

 

192,183

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic/Diagnostics product and service revenue

 

121,163

 

124,840

 

129,194

 

132,955

 

133,748

 

10

%

410,917

 

477,614

 

395,897

 

Transplant product and service revenue

 

47,784

 

50,723

 

52,666

 

56,060

 

55,604

 

16

%

174,826

 

192,200

 

164,330

 

Other product and service revenue

 

28,598

 

30,252

 

23,501

 

22,423

 

18,496

 

(35

)%

108,577

 

119,155

 

64,420

 

Total Other product and service revenue

 

197,545

 

205,815

 

205,361

 

211,438

 

207,848

 

5

%

694,320

 

788,969

 

624,647

 

R&D revenue

 

959

 

305

 

778

 

596

 

582

 

(39

)%

3,218

 

3,048

 

1,956

 

Total Other

 

198,504

 

206,120

 

206,139

 

212,034

 

208,430

 

5

%

697,538

 

792,017

 

626,603

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

1,160,284

 

$

1,173,560

 

$

1,148,871

 

$

1,228,510

 

$

1,057,514

 

(9

)%

$

3,813,519

 

$

4,605,039

 

$

3,434,895

 

 

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 September 30, 2009

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER DISCRETE ITEMS

 

 

 

 

 

 

 

Bayer

 

 

 

 

 

 

 

(included in GAAP and Non-GAAP results)

 

 

 

GAAP

 

Acquisition

 

FAS 123R

 

 

 

 

 

Allston

 

Technology

 

 

 

As Reported

 

Related

 

Expense

 

NON-GAAP (1)

 

Remediation

 

Purchase

 

Income Statement Classification:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

 

 

$

 1,057,514

 

 

 

 

 

 

 

$

 1,057,514

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of products and services sold

 

 

 

$

 (359,407

)

$

 17,740

 

$

 7,575

 

 

 

$

 (334,092

)

$

 23,735

 

 

 

Gross margin

 

66

%

$

 698,107

 

$

 17,740

 

$

 7,575

 

68

%

$

 723,422

 

$

 23,735

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

 

$

 (367,347

)

 

 

$

 24,648

 

 

 

$

 (342,699

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

$

 (219,275

)

 

 

$

 14,058

 

 

 

$

 (205,217

)

 

 

$

 7,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangibles

 

 

 

$

 (71,280

)

 

 

 

 

 

 

$

 (71,280

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration expense

 

 

 

$

 (28,197

)

$

 28,197

 

 

 

 

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gains (losses) on investments in equity securities

 

 

 

$

 (651

)

 

 

 

 

 

 

$

 (651

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain on acquisition of business

 

 

 

$

 —

 

 

 

 

 

 

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

$

 617

 

 

 

 

 

 

 

$

 617

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

 

 

$

 4,543

 

 

 

 

 

 

 

$

 4,543

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

 

$

 —

 

 

 

 

 

 

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

 

$

 16,517

 

$

 45,937

 

$

 46,281

 

 

 

$

 108,735

 

$

 23,735

 

$

 7,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Provision for) benefit from income taxes

 

3.16

%

$

 (522

)

$

 (11,646

)

$

 (12,700

)

22.87

%

$

 (24,868

)

$

 (4,225

)

$

 (1,574

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

 

 

$

 15,995

 

$

 34,291

 

$

 33,581

 

 

 

$

 83,867

 

$

 19,510

 

$

 5,426

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

$

 0.06

 

$

 0.13

 

$

 0.12

 

 

 

$

 0.31

 

$

 0.07

 

$

 0.02

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted

 

 

 

$

 0.06

 

$

 0.13

 

$

 0.12

 

 

 

$

 0.31

 

$

 0.07

 

$

 0.02

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

268,957

 

268,957

 

268,957

 

 

 

268,957

 

268,957

 

268,957

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted

 

 

 

273,741

 

273,741

 

273,741

 

 

 

273,741

 

273,741

 

273,741

 

 


Notes:

 

(1) Represents the Non-GAAP results of operations for Genzyme Corporation for the three months ended September 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.