-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, BSaxbS6B2NpfjPxgREZOIY5PU6zDgIhVcRL57laFGkTSeqV11wbED+Ip5B2PLbd2 CE3wP6hMpBAq3rFCJgPgCw== 0000913610-03-000028.txt : 20030428 0000913610-03-000028.hdr.sgml : 20030428 20030428160733 ACCESSION NUMBER: 0000913610-03-000028 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20030428 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030428 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SANGSTAT MEDICAL CORP CENTRAL INDEX KEY: 0000913610 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943076069 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-22890 FILM NUMBER: 03666951 BUSINESS ADDRESS: STREET 1: 6300 DUMBARTON CIRCLE CITY: FREMONT STATE: CA ZIP: 94555 BUSINESS PHONE: 5107894300 MAIL ADDRESS: STREET 1: 6300 DUMBARTON CIRCLE CITY: FREMONT STATE: CA ZIP: 94555 8-K 1 form8kfinal.htm FORM 8-K DATED APRIL 28, 2003 SECURITIES AND EXCHANGE COMMISSION

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549


FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

April 28, 2003
(Date of earliest event reported)

Message

SANGSTAT MEDICAL CORPORATION
(Exact name of Registrant as specified in its charter)

                          Delaware                                                                           0-22890                                                                  94-3076-069
(State of incorporation or organization)                                     (Commission File No.)                                     (IRS Employer Identification No.)

6300 Dumbarton Circle
Fremont, CA 94555
(Address of principal executive offices)

(510) 789-4300
(Registrant’s telephone number, including area code)



Item 5.                    Other Events

                                On April 28, 2003, SangStat Medical Corporation issued the attached press release announcing its sales and earnings for the period ended March 31, 2003.

Item 7.                    Exhibits.

                                (a)           Not applicable.

                                (b)           Not applicable.

                                (c)           Not applicable.

                                Exhibit No.                                                                                             Description                                                          

                                99.1                                         Press release dated April 28, 2003.

Item 9.                    Regulation FD Disclosure

                                Incorporated by reference is a press release issued by the Registrant on April 28, 2003, regarding earnings for the first quarter 2003, attached as Exhibit 99.1.  This information is being furnished pursuant to Item 12 – Results of Operations and Financial Condition, of Form 8-K and is being presented under Item 9 of Form 8-K in accordance with interim guidance issued by the Securities and Exchange Commission in Release Nos.  33-8216 and 34-47583.  This information is not deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 and is not incorporated by reference into any Securities Act registration statements.

2



SIGNATURE

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

                                                                                                                                SANGSTAT MEDICAL CORPORATION



                                                                                                                                By:          /s/ Stephen G. Dance                                          
                                                                                                                                                Stephen G. Dance
Date:  April 28, 2003                                                                                                             Chief Financial Officer

3



EXHIBIT INDEX

                Exhibit No.                                                                            Description                                                                          

                99.1                         Press release dated April 28, 2003.

4


EX-99.1 3 pressrelease.htm PRESS RELEASE

EXHIBIT 99.1

 

 

Contact:

Stephen G. Dance

 

510-789-4304

FOR IMMEDIATE RELEASE

SANGSTAT ANNOUNCES Q1 2003 EARNINGS PER SHARE OF $0.07 ON REVENUES OF $29.5 MILLION

Fremont, Calif.- April 28, 2003 - SangStat Medical Corporation (Nasdaq: SANG) today announced first quarter 2003 earnings per share (EPS) of $0.07 and worldwide revenues of $29.5 million, an increase of 22 percent over first quarter 2002.  Sales of SangStat's lead marketed product, Thymoglobulin® [anti-Thymocyte globulin, rabbit] in North America in the first quarter of 2003 were $13.7 million, a 30 percent increase over first quarter 2002 sales.

SangStat generated $1.8 million in net income in the first quarter of 2003 and reduced its outstanding debt by $2.0 million.  SangStat ended the first quarter of 2003 with available cash, cash equivalents and short-term investments of $94.6 million.  The first quarter results included a one-time benefit to net income of $0.7 million from the favorable settlement of a lawsuit that SangStat had appealed to the French Supreme Court.

“In the first quarter of 2003 we completed the first Phase II studies of RDP58, our novel anti-inflammatory,” said Rick Murdock, Chairman, President and CEO.  “While we are proud of our continued success with Thymoglobulin in solid organ transplantation, RDP58’s promising results in ulcerative colitis may open up markets that are many times larger than those we currently access.”

Research and development expenses, including discovery research, regulatory, and clinical expenses, were $4.4 million in the first quarter of 2003 versus $4.3 million for the first quarter of 2002. Selling, general and administrative expenses in the first quarter of 2003 were $9.3 million compared to $8.0 million in the first quarter of 2002.

Thymoglobulin

Thymoglobulin sales have continued to drive SangStat’s top and bottom lines.  In the first quarter of 2003 Thymoglobulin sales in North America reached $13.7 million, an increase of 30 percent over the first quarter 2002 and an 18 percent decrease from fourth quarter 2002.  Historically, sales of Thymoglobulin are lower in the first quarter, due to seasonal trends.

SangStat currently maintains about a 50 percent dollar market share of the immunosuppressive antibody market.  Since Thymoglobulin is the price leader in the class, the Company believes its share of the patient market is significantly smaller, approximately 35 percent, leaving room for continued growth.  SangStat believes that current and future clinical studies of Thymoglobulin set the stage for continued growth in sales.  SangStat intends to initiate new studies in 2003 to assess Thymoglobulin’s effectiveness at preventing acute rejection in living-donor kidney transplants and as a conditioning agent in bone marrow transplantation (BMT). 

Gengraf™ (cyclosporine capsules)

According to IMS Health reports, end-user demand for Gengraf grew to a high of 18.6% of the cyclosporine dollar market in the first two months of the first quarter of 2003.  Gengraf has also achieved 17.9% of the prescription market, making it the leading generic cyclosporine according to IMS.  Factory sales of Gengraf in the first quarter 2003 were $7.8 million, an increase of 17 percent over first quarter 2002 and a slight increase of 1 percent over fourth quarter 2002. The Company believes that wholesaler destocking, which began in the fourth quarter of 2002, continued into the first quarter of 2003.  SangStat anticipates that wholesaler stocking and destocking issues may continue in the future.

On March 27, 2003 a federal court ruled that Gengraf® (cyclosporine) does not infringe a Novartis patent. The Delaware District Court granted a motion filed by Abbott Laboratories requesting the Court to overturn a prior jury verdict, from July 2002, that had found infringement. Novartis had sued Abbott to prevent sales of Gengraf.  Although Novartis stated its intent to pursue an appeal of the court’s ruling, this decision significantly reduced the uncertainty surrounding SangStat’s sales of Gengraf.

RDP58

SangStat completed initial Phase II studies of RDP58, its potent anti-inflammatory peptide, in the first quarter of 2003 in both ulcerative colitis (UC) and Crohn’s disease.  The preliminary results of the Phase II studies of RDP58 at 100mg, 200mg and 300mg per day in UC and Crohn’s were released on April 9, 2003.  The Phase II studies of RDP58 demonstrated a peak response rate of 77 percent and a 71 percent remission rate among patients with ulcerative colitis taking 200mg/day of active drug.  Patients with ulcerative colitis who received 300mg/day of RDP58 achieved similar response and remission rates.


Overall, both the response and remission rates were statistically significant.  In Crohn’s disease, although 66 percent of patients treated with 200mg/day of RDP58 achieved a response, the study did not yield a statistically significant dose response.  SangStat believes that additional analysis and clinical studies using higher dosing and longer administration may be needed to determine efficacy in Crohn’s disease. 

SangStat also initiated a U.S. Phase Ib study in chemotherapy-induced diarrhea in the first quarter of 2003.  In addition to RDP58, SangStat is developing second and third generation anti-inflammatory peptides and hopes to begin pre-clinical testing of new compounds later this year.

Webcast/Conference Call

SangStat will host an investor conference call today (Monday), April 28, 2003 at 4:30pm EDT (1:30pm PDT) to discuss the first quarter results.  The call can be accessed either through the call in numbers or through the audio webcast via a link on SangStat’s website at www.Sangstat.com . The access numbers for the call are as follows:

US:

888-331-0066

 

 

Int’l:

203-748-8964

 

 

Password: SangStat

The replay will be available at least until the end of the day on Friday, May 2.  It can be accessed by calling:

US:

888-566-0859

 

 

Int’l:

402-220-0449

SangStat

SangStat is a global biotechnology company focused on immunology and working to discover, develop and market high value therapeutic products in the autoimmune, hematology/oncology and immunosuppression areas.  SangStat’s U.S. headquarters are in Fremont, California.  SangStat also maintains a strong European presence, including direct sales and marketing forces in France, Germany, Italy, Spain, and the UK, and distributors throughout the rest of the world. SangStat’s stock is traded on the Nasdaq under the symbol “SANG”.  The company’s web site is located at www.sangstat.com.

This press release contains forward-looking statements that involve risks and uncertainties. Forward-looking statements reflect SangStat’s current views with respect to future events. Forward-looking statements include future financial, sales or operating results, expenses, Gengraf sales, anticipated clinical developments and timelines, and potential uses or properties of products or product candidates. Actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated. Factors that could cause actual results to differ materially include, without limitation:  progress and results of the Thymoglobulin and RDP58 studies; market conditions or other developments such as new competitors; increased sales or price reductions by competitors; reduction in margin on key products; reduction in demand or failure of demand to reach anticipated levels; manufacturing matters and potential delays; increases in expenses; changes in reimbursement for products; patent and other litigation including results from the pending Gengraf litigation; licensing or product transactions; delays in clinical trial enrollment; complications or delays in conducting pre- clinical or clinical trials; problems obtaining approvals from regulatory agencies; or changes in management. For a discussion of these and other factors that might result in different outcomes, see “Risk Factors” in SangStat’s 2002 Annual Report on Form 10-K, its 2003 quarterly reports on Form 10-Q and other documents filed with the Securities and Exchange Commission. SangStat assumes no obligation to update any such forward-looking statements, risks or reasons why actual results might differ.

# # #


SANGSTAT MEDICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)

 

 

Three Months Ended March 31,

 

 

 


 

 

 

2003

 

2002

 

 

 


 


 

REVENUES:

 

 

 

 

 

 

 

 

Net product sales

 

$

28,738

 

$

23,355

 

 

Revenue from collaborative agreements

 

 

790

 

 

789

 

 

 

 



 



 

 

Total revenues

 

 

29,528

 

 

24,144

 

 

 



 



 

 

 

 

 

 

 

 

 

COSTS AND OPERATING EXPENSES:

 

 

 

 

 

 

 

 

Cost of product sales

 

 

13,684

 

 

10,623

 

 

Research and development

 

 

4,426

 

 

4,318

 

 

Selling, general and administrative

 

 

9,252

 

 

7,953

 

 

Amortization of intangible assets

 

 

250

 

 

250

 

 

 

 



 



 

 

Total costs and operating expenses

 

 

27,612

 

 

23,144

 

 

 



 



 

 

 

 

 

 

 

 

 

 

Income from operations

 

 

1,916

 

 

1,000

 

 

 

 

 

 

 

 

 

OTHER INCOME - NET

 

 

734

 

 

111

 

EQUITY IN NET LOSS OF AFFILIATE

 

 

(404

)

 

—  

 

 

 



 



 

INCOME FROM OPERATIONS BEFORE INCOME TAXES

 

 

2,246

 

 

1,111

 

 

 

 

 

 

 

 

 

INCOME TAX PROVISION

 

 

422

 

 

433

 

 

 



 



 

NET INCOME

 

$

1,824

 

$

678

 

 

 



 



 

 

 

 

 

 

 

 

 

NET INCOME PER COMMON SHARE - BASIC

 

$

0.07

 

$

0.03

 

NET INCOME PER COMMON SHARE - DILUTED

 

$

0.07

 

$

0.03

 

 

 

 

 

 

 

 

 

Shares Used in Per Share Computations - Basic

 

 

26,445

 

 

24,032

 

Shares Used in Per Share Computations - Diluted

 

 

26,521

 

 

24,766

 


 

CONDENSED CONSOLIDATED BALANCE SHEET DATA:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31,
2003

 

December 31,
2002

 

 

 



 



 

Cash and Equivalents and Short-term Investments

 

$

94,589

 

$

97,512

 

Other Current Assets

 

 

56,825

 

 

59,457

 

Property and Equipment - Net

 

 

5,645

 

 

5,824

 

Investment in Affiliate

 

 

2,632

 

 

3,036

 

Intangible Assets

 

 

7,392

 

 

7,642

 

Other Assets

 

 

18,792

 

 

18,966

 

 

 



 



 

 

 

 

 

 

 

 

 

 

Total

 

$

185,875

 

$

192,437

 

 

 



 



 

 

 

 

 

 

 

 

 

Current Liabilities

 

$

44,990

 

$

43,439

 

Deferred Revenue

 

 

2,368

 

 

3,158

 

Notes Payable and Capital Leases

 

 

5,929

 

 

15,920

 

Stockholders’ Equity

 

 

132,588

 

 

129,920

 

 

 



 



 

 

 

 

 

 

 

 

 

 

Total

 

$

185,875

 

$

192,437

 

 

 

 



 



 

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