<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) July 21, 1999
CENTOCOR, INC.
-----------------------------------------------------------------
(Exact name of registrant as specified in its charter)
Pennsylvania 0-11103 23-2117202
--------------------------------------------------------------
(State or other (Commission file (IRS Employer
jurisdiction of number) Identification No.)
incorporation)
200 Great Valley Parkway, Malvern, Pennsylvania 19355
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (215) 651-6000
--------------
Not applicable
-----------------------------------------------------------------
(Former name or former address, if changed since last report)
<PAGE>
Item 5. Other Events
------------
On July 21, 1999, Centocor, Inc. issued a news release relating to its
financial results for the second quarter of 1999, a copy of which is filed
herewith as Exhibit 99 and is incorporated herein by reference.
Item 7. Exhibits
--------
99 Centocor, Inc. news release dated July 21, 1999
SIGNATURES
-----------
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CENTOCOR, INC.
Registrant
Dated: July 28, 1999 By: /s/ George D. Hobbs
------------------------------
George D. Hobbs, Senior Vice
President and General Counsel
EXHIBIT INDEX
99 Centocor, Inc. news release dated July 21, 1999
<PAGE>
Exhibit 99
News Release
For Immediate Release Contacts: Investors Media
--------- -----
Bill Newbould Christopher Allman
(610) 651-6122 (610) 651-6546
CENTOCOR ACHIEVES RECORD QUARTERLY PRODUCT SALES
- Announces Positive X-Ray Data From Attract Trial -
MALVERN, Pa., July 21, 1999 - Centocor, Inc. (Nasdaq: CNTO) today reported net
income of $9.1 million, or $0.13 per basic and diluted earnings per share, for
the second quarter of 1999. In the second quarter of 1998, net income from
operations, excluding a net after-tax gain from significant one-time events of
$17.4 million, or $0.24 per basic and diluted share, was $1.9 million, or $0.03
per basic and diluted share.
Centocor also announced that it has obtained and plans to submit to the Food and
Drug Administration (FDA) positive radiographic (x-ray) data at 30 and 54 weeks
from an ongoing clinical study of REMICADE /TM/ (infliximab) in patients with
rheumatoid arthritis. The results show a benefit favoring REMICADE with
methotrexate over methotrexate alone at all doses studied. The company believes
the findings meet the prospectively defined endpoint of prevention of
progression of joint damage, as measured by radiographic assessment.
Product sales were a record $115.1 million for the 1999 second quarter, an
increase of 65% from product sales of $69.9 million in the 1998 second quarter
which included $7.0 million in sales from the company's diagnostics business
that was sold in November 1998. Excluding diagnostic sales, product sales rose
83% from the year-ago second quarter.
The gross margin was 67.6% for the second quarter of 1999 versus 65.1% in the
same period of 1998, and operating earnings before interest and taxes were 16.4%
of sales in the 1999 second quarter versus 6.2% for the three months ended June
30, 1998.
For the first half of 1999, net income from operations was $16.1 million, or
$0.23 per basic share and $0.22 per diluted share. This compares with operating
net income of $3.5 million, or $0.05 per basic and diluted share, for the six
months ended June 30, 1998.
Net income for the first half of 1999, including a one-time, after-tax gain from
the sale of an equity investment of $3.1 million, or $0.04 per basic and diluted
share, was $19.2 million, or $0.27 per basic and diluted share. For the six
months ended June 30, 1998, the basic and diluted loss was $1.72 per share on a
net loss of $121.0 million, including special charges primarily in connection
with the RETAVASE acquisition, which was completed March 13, 1998.
For the first six months of 1999, product sales were $215.6 million, a 92.7%
increase from $111.9 million in the first half of 1998, which excludes $14.5
million in diagnostic sales. The gross margin was 67.7% and 64.3% for the first
six months of 1999 and 1998, respectively, and operating earnings before
interest and taxes improved to 14.9% for the 1999 first half compared with 3.7%
for the first six months of 1998.
<PAGE>
- 2 -
Product Review
ReoPro[] (abciximab)
- --------------------
[] Second quarter end sales to customers by Eli Lilly and Company, Centocor's
marketing partner for ReoPro, were a record $114.3 million for the second
quarter of 1999, up 13% from $101 million reported in both the year-ago second
quarter and the first quarter of 1999. The 1999 second quarter total reflects
record quarterly U.S. sales of $92.4 million and record quarterly international
sales of $21.9 million. International sales grew 51% from the 1998 second
quarter.
[] Centocor sales to Lilly were $65.6 million in the 1999 second quarter, an
increase of 38% from $47.5 million in the same period of 1998.
[] For the six months ended June 30, 1999, ReoPro end sales were $215.2 million
versus $170.9 million in the same period last year, a 26% increase. Centocor's
sales to Lilly were $123.6 million in the first six months of 1999, up 33% from
$93.2 million in the same period of 1998.
[] In June, ReoPro reached a major milestone in its history when cumulative
sales passed the $1 billion mark. Since its launch in early 1995, more than
750,000 patients have been treated with ReoPro.
[] During the quarter, four peer-reviewed articles about ReoPro clinical trial
data appeared in leading medical journals, as follows: the April 20 issue of
Circulation published one-year results from the EPILOG trial; The New England
Journal of Medicine featured an article on a substudy from the CAPTURE trial in
the May 27 issue; the Journal of the American College of Cardiology included an
article on the GRAPE pilot study; and an article and editorial discussing the
positive results of the TIMI 14 trial appeared in the June 1 issue of
Circulation. Together with an article published in the March issue of the
Journal of the American College of Cardiology, this makes five peer-reviewed
articles about ReoPro in four months. This is a tribute to the quality of
ReoPro's clinical trial data, which over the years has been a major factor in
its success.
[] During the quarter, Centocor and Lilly announced they have initiated the
Acute Coronary Syndromes Registry(TM) (ACS Registry), a database that follows
patients with ACS from symptom onset through outcome. The goal of the
multicenter, observational study is to define optimal treatment strategies for
the nearly two million Americans who suffer from acute myocardial infarction and
unstable angina each year.
RETAVASE[] (reteplase)
- ---------------------
[] RETAVASE sales were a record $24.9 million for the second quarter of 1999,
rising 64% from $15.2 million in the year-ago second quarter. For the six
months, sales were $45.3 million in 1999 versus $27.4 million in 1998, an
increase of 65%.
[] As a result of the announcement on June 3 that Roche will exercise its call
option on the remaining Genentech, Inc. shares it does not already own in
accordance with the consent decree between Roche and the Federal Trade
Commission in connection with Roche's acquisition of Corange, Ltd., Genentech
will dismiss all pending litigation against Centocor regarding RETAVASE.
Corange was the parent company of Boehringer Mannheim, the manufacturer of
RETAVASE, when Centocor acquired the U.S. and Canadian marketing rights to
RETAVASE in March 1998.
<PAGE>
- 3 -
[] During the quarter, the GUSTO IV-AMI trial, designed to evaluate the
combination therapy of ReoPro and RETAVASE in the treatment of heart attacks,
began enrolling patients.
[] The July 1999 issue of American Heart Journal includes an article and related
editorial on a study that showed RETAVASE to compare favorably with alteplase in
massive pulmonary embolism.
[] At the upcoming European Society of Cardiology meeting, to be held August 28-
September 1, final data will be presented from the SPEED trial, the pilot study
for GUSTO IV-AMI. Final results from the TIMI 14 trial, which evaluated the
combination therapy of ReoPro and low-dose fibrinlolytics in the treatment of
heart attacks, are expected to be presented at the American Heart Association
meeting in November.
FRAGMIN(R) (dalteparin sodium injection)
- ----------------------------------------
(S) On May 26, the FDA approved FRAGMIN for the treatment of unstable angina
and non-Q-wave myocardial infarction for the prevention of ischemic
complications due to blood clot formation in patients on concurrent aspirin
therapy. Centocor began co-promoting FRAGMIN with Pharmacia & Upjohn in March.
REMICADE[] (infliximab)
- ----------------------
(S) Sales of REMICADE were $23.3 million for the second quarter of 1999
compared with $21.1 million for the 1999 first quarter. For the first half of
1999, REMICADE sales were $44.4 million.
(S) On May 24, the European Union's Committee for Proprietary Medicinal
Products (CPMP) issued a positive opinion recommending that REMICADE be approved
for marketing in Europe for the treatment of severe Crohn's disease. The CPMP
opinion is the basis for a European Commission approval, typically issued within
three to four months of the CPMP's recommendation. Upon final approval,
Schering-Plough Corp. will be the exclusive distributor of the drug in Europe.
(S) At the Digestive Disease Week meeting in mid-May, data presented from a
study in pediatric Crohn's patients showed that REMICADE dramatically improved
symptoms of the disease in the majority of the children with no significant
adverse effects from the treatment.
(S) The May 5 issue of The New England Journal of Medicine featured an article
about a clinical trial involving 94 patients that demonstrated REMICADE's
effectiveness in healing fistulas, a serious complication of Crohn's disease.
(S) A summary of results from the ATTRACT trial, presented at the European
League Against Rheumatism meeting in Glasgow, Scotland, on June 7, showed that
REMICADE produced significant reductions of signs and symptoms that were
sustained or further reduced from 30 weeks through 54 weeks of therapy in
patients with advanced rheumatoid arthritis. In addition, REMICADE was
generally well tolerated and side effects were minimal.
(S) During the quarter, patient enrollment began in the ACCENT trial, designed
to evaluate the benefits of REMICADE as maintenance therapy for Crohn's disease.
Currently, REMICADE is indicated for short-term management of the disease.
<PAGE>
- 4 -
(S) On June 11, the FDA honored Richard V. McCloskey, M.D., vice president
and chief medical officer for Centocor, with the Commissioner's Special Citation
for his role in helping develop REMICADE as a treatment for patients with
Crohn's disease.
Other
(S) On July 1, Standard & Poor's assigned a double-`B' corporate credit rating
to Centocor, Inc. At the same time, S&P assigned a single-`B'-plus rating to
Centocor's outstanding $460 million, 4 3/4% convertible subordinated notes due
2000. The credit rating agency also rated the company's outlook as positive.
Certain of the matters discussed herein with respect to future earnings,
clinical studies and the Company's products may constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements are based on current expectations,
estimates and projections about the Company's industry, management's beliefs and
certain assumptions made by the Company's management. Investors are cautioned
that matters subject to forward-looking statements involve risks and
uncertainties, including economic, competitive, governmental, technological and
other factors discussed in the Company's filings with the Securities and
Exchange Commission, which may affect the Company's business and prospects.
These statements are not guarantees of future performance and are subject to
certain risks, uncertainties and assumptions that are difficult to predict.
Unless required by law, the Company undertakes no obligation to update publicly
any forward-looking statements, whether as a result of new information, future
events or otherwise.
On the Internet: More company information can be found on Centocor's homepage at
WWW.CENTOCOR.COM
- XXX -
(Tables Attached)
ReoPro[] is a registered trademark of Eli Lilly and Company.
<PAGE>
CENTOCOR, INC.
SUMMARY STATEMENT OF OPERATIONS
(in thousands except per share data)
(Unaudited)
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------------------
For the three months ended For the six months ended
June 30, 1999 June 30, 1998 June 30, 1999 June 30, 1998
- -------------------------------------------------------- --------------- --------------- --------------- ---------------
<S> <C> <C> <C> <C>
Revenues:
Sales $ 115,125 $ 69,880 $ 215,622 $ 126,385
Contracts 1,996 21,002 2,246 21,362
- -------------------------------------------------------- --------------- --------------- --------------- ---------------
117,121 90,882 217,868 147,747
Costs and expenses 98,256 66,578 185,825 123,118
Special charges* -- -- -- 145,405
Other income (expense), net** (3,639) (3,574) (10) 1,349
- -------------------------------------------------------- --------------- --------------- --------------- ---------------
Income (loss) before provision
for income taxes 15,226 20,730 32,033 (119,427)
Income tax provision 6,090 1,450 12,813 1,600
- -------------------------------------------------------- --------------- --------------- --------------- ---------------
Net income (loss) $ 9,136 $ 19,280 $ 19,220 $ (121,027)
======================================================== =============== =============== =============== ===============
Earnings per share from operations (basic) $ 0.13 $ 0.03 $ 0.23 $ 0.05
======================================================== =============== =============== =============== ===============
Earnings per share from operations (diluted) $ 0.13 $ 0.03 $ 0.22 $ 0.05
======================================================== =============== =============== =============== ===============
Basic earnings (loss) per share*** $ 0.13 $ 0.27 $ 0.27 $ (1.72)
======================================================== =============== =============== =============== ===============
Diluted earnings (loss) per share $ 0.13 $ 0.27 $ 0.27 $ (1.72)
======================================================== =============== =============== =============== ===============
Weighted average number
of shares outstanding 70,939 70,384 70,901 70,284
======================================================== =============== =============== =============== ===============
Weighted average common and dilutive
equivalent shares outstanding 72,663 72,144 72,518 70,284
======================================================== =============== =============== =============== ===============
</TABLE>
*Special charges for the six months ended June 30, 1998 includes a charge of
$139.4 million relating to the acquisition of RETAVASE and a charge of $6.0
million related to a restructuring of Centocor Diagnostics Inc.
**Other income (expense), net for the six months ended June 30, 1999 includes a
gain on sale of the Company's investment in Biometric Imaging, Inc. of $5.2
million. Other income (expense), net for the six months ended June 30, 1998
includes a gain on the sale of the Company's investment in ChromaVision Medical
Systems, Inc. for $6.9 million and a charge of $4.7 million related to the
settlement of litigation.
***Net Income from operations for the six months ended June 30, 1999, which
excludes the gain on sale of the Company's investment in Biometric Imaging,
Inc., is $0.23 per share (basic) and $0.22 per share (diluted). For the six
months ended June 30, 1998 net income from operations excluding significant
one-time items such as REMICADE contract revenue, special charges, gain on sale
of the Company's Chroma Vision Medical Systems, Inc. investment and litigation
charges is $0.05 per share (basic and diluted). Net income from operations for
the three months ended June 30, 1998, which excludes significant one-time items
such as REMICADE contract revenue of $20 million and a litigation charge of $1.3
million, is $0.03 per share (basic and diluted).
<PAGE>
CENTOCOR, INC
QUARTERLY STATEMENTS OF OPERATIONS
(in thousands except per share data)
(Unaudited)
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------------------
YEAR YEAR
TO DATE TO DATE
THROUGH THROUGH
For the three months ended: 3.31.98 6.30.98 9.30.98 12.31.98 12.31.98 3.31.99 6.30.99 6.30.99
- ------------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
REVENUES
Sales $ 56,505 $ 69,880 $ 87,602 $ 102,724 $ 316,711 $ 100,497 $115,125 $ 215,622
Contracts 360 21,002 67 -- 21,429 250 1,996 2,246
----------------------------------------------------------------------------------------------
56,865 90,882 87,669 102,724 338,140 100,747 117,121 217,868
COSTS AND EXPENSES
Cost of sales 20,760 24,422 32,220 30,853 108,255 32,364 37,258 69,622
Research and development 19,913 16,048 12,728 18,232 66,921 20,951 21,559 42,510
Marketing, general and
administrative 15,867 26,108 36,123 41,659 119,757 34,254 39,439 73,693
Special charges 145,405 -- -- -- 145,405 -- -- --
----------------------------------------------------------------------------------------------
201,945 66,578 81,071 90,744 440,338 87,569 98,256 185,825
OTHER INCOME (EXPENSE)
Interest income 4,164 3,636 3,357 3,515 14,672 2,231 2,003 4,234
Interest expense (2,687) (5,634) (5,815) (5,037) (19,173) (5,327) (4,657) (9,984)
Litigation charge (3,430) (1,300) -- -- (4,730) -- -- --
Gain on sale of investment 6,931 -- -- -- 6,931 5,196 -- 5,196
Gain on sale of Diagnostics
related assets -- -- -- 18,620 18,620 -- -- --
Other (55) (276) (388) 503 (216) 1,529 (985) 544
----------------------------------------------------------------------------------------------
4,923 (3,574) (2,846) 17,601 16,104 3,629 (3,639) (10)
Income (loss) before provision
(benefit) for income taxes (140,157) 20,730 3,752 29,581 (86,094) 16,807 15,226 32,033
Provision for income taxes 150 1,450 265 2,071 3,936 6,723 6,090 12,813
Income tax benefit -- -- -- (282,317) (282,317) -- -- --
----------------------------------------------------------------------------------------------
Net income (loss) $(140,307) $ 19,280 $ 3,487 $ 309,827 $ 192,287 $ 10,084 $ 9,136 $ 19,220
==============================================================================================
Basic earnings (loss) per share $ (2.00) $ 0.27 $ 0.05 $ 4.38 $ 2.73 $ 0.14 $ 0.13 $ 0.27
==============================================================================================
Diluted earnings (loss) per share $ (2.00) $ 0.27 $ 0.05 $ 3.86 $ 2.59 $ 0.14 $ 0.13 $ 0.27
==============================================================================================
Weighted average number
of shares outstanding 70,185 70,384 70,502 70,680 70,437 70,863 70,939 70,901
==============================================================================================
Weighted average common and
dilutive equivalent shares
outstanding 70,185 72,144 71,974 81,706 81,435 72,388 72,663 72,518
==============================================================================================
</TABLE>
<PAGE>
CENTOCOR, INC.
SUMMARY OF CONSOLIDATED BALANCE SHEET INFORMATION
(in thousands except per share data)
(Unaudited)
<TABLE>
<CAPTION>
-----------------------------------------------------------------------------------------
MARCH 31, JUNE 30, SEPTEMBER 30, DECEMBER 31, MARCH 31, JUNE 30,
1998 1998 1998 1998 1999 1999
-----------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C>
SELECTED
BALANCE SHEET CAPTION:
CASH & CASH INVESTMENTS $ 297,821 $ 246,791 $ 214,157 $ 220,270 $ 206,977 $ 189,329
EQUITY INVESTMENTS 2,554 3,193 6,650 6,332 4,962 5,923
NET FIXED ASSETS 89,958 106,816 132,605 155,423 182,082 206,319
DEFERRED TAX ASSETS -- -- -- 312,188 305,684 300,899
OTHER ASSETS 334,337 368,119 379,408 387,876 365,540 404,052
-----------------------------------------------------------------------------------------
TOTAL ASSETS $ 724,670 $ 724,919 $ 732,820 $1,082,089 $1,065,245 $1,106,522
=========================================================================================
DEBT $ 520,534 $ 465,882 $ 466,316 $ 466,383 $ 465,882 $ 465,607
OTHER LIABILITIES 94,535 126,172 123,318 129,487 107,082 140,136
-----------------------------------------------------------------------------------------
TOTAL LIABILITIES 615,069 592,054 589,634 595,870 572,964 605,743
SHAREHOLDERS' EQUITY 109,601 132,865 143,186 486,219 492,281 500,779
-----------------------------------------------------------------------------------------
TOTAL LIABILITIES &
SHAREHOLDERS' EQUITY $ 724,670 $ 724,919 $ 732,820 $1,082,089 $1,065,245 $1,106,522
=========================================================================================
COMMON STOCK OUTSTANDING 70,193 70,415 70,540 70,756 70,902 70,966
BOOK VALUE PER SHARE $ 1.56 $ 1.89 $ 2.03 $ 6.87 $ 6.94 $ 7.06
</TABLE>
<PAGE>
CENTOCOR, INC.
SUPPLEMENTAL STATEMENTS OF OPERATIONS DATA
(in thousands except per share data)
(Unaudited)
<TABLE>
<CAPTION>
- -------------------------------------------------------------------------------------------------------------------------
Three months ended June 30, 1999 1998 Proforma 1998*
- -------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C>
REVENUES:
Sales $ 115,125 $ 69,880 $ 62,880
Contracts 1,996 21,002 20,000
------------ ----------- --------------
117,121 90,882 82,880
COSTS AND EXPENSES:
Cost of sales 37,258 24,422 20,893
Research and development 21,559 16,048 14,716
Marketing, general and administrative 39,439 26,108 24,158
------------ ----------- --------------
98,256 66,578 59,767
OTHER INCOME (EXPENSE):
Interest income 2,003 3,636 3,636
Interest expense (4,657) (5,634) (5,634)
Litigation settlement -- (1,300) (1,300)
Other (985) (276) (93)
------------ ----------- --------------
(3,639) (3,574) (3,391)
Income before provision for income taxes 15,226 20,730 19,722
Provision for income taxes 6,090 1,450 7,889
------------ ----------- --------------
Net income $ 9,136 $ 19,280 $ 11,833
============ =========== ==============
Basic earnings per share $ 0.13 $ 0.27 $ 0.17
============ =========== ==============
Diluted earnings per share $ 0.13 $ 0.27 $ 0.16
============ =========== ==============
Weighted average number of shares
outstanding 70,939 70,384 70,384
============ =========== ==============
Weighted average common and dilutive
equivalent shares outstanding 72,663 72,144 72,144
============ =========== ==============
Operating statistics:
Gross margin as a percentage of sales 67.6% 65.1% 66.8%
Operating EBIT $ 18,865 $ 4,304 $ 3,113
Operating EBIT as a percentage of sales 16.4% 6.2% 5.0%
Net income from operations (after tax) $ 9,136 $ 1,888 $ 613
Operating earnings per share (basic and diluted) $ 0.13 $ 0.03 $ 0.01
</TABLE>
* 1998 Proforma shows the effects of removing the Diagnostic business activities
and assumes a 40% effective tax rate.
<PAGE>
CENTOCOR, INC.
SUPPLEMENTAL STATEMENTS OF OPERATIONS DATA
(in thousands except per share data)
(Unaudited)
<TABLE>
<CAPTION>
- -------------------------------------------------------------------------------------------------------------------------
Six months ended June 30, 1999 1998 Proforma 1998*
- -------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C>
REVENUES:
Sales $ 215,622 $ 126,385 $ 111,878
Contracts 2,246 21,362 20,000
------------ ----------- --------------
217,868 147,747 131,878
COSTS AND EXPENSES:
Cost of sales 69,622 45,182 38,537
Research and development 42,510 35,961 31,382
Marketing, general and administrative 73,693 41,975 38,290
Special charges -- 145,405 139,437
------------ ----------- --------------
185,825 268,523 247,646
OTHER INCOME
Interest income 4,234 7,800 7,800
Interest expense (9,984) (8,321) (8,321)
Gain on sale of investment 5,196 6,931 --
Litigation settlement -- (4,730) (4,730)
Other 544 (331) (148)
------------ ----------- --------------
(10) 1,349 (5,399)
Income (loss) before provision for income taxes 32,033 (119,427) (121,167)
Provision for income taxes 12,813 1,600 8,680
------------ ----------- --------------
Net income (loss) $ 19,220 $ (121,027) $ (129,847)
============ =========== ==============
Basic earnings per share $ 0.27 $ (1.72) $ (1.85)
============ =========== ==============
Diluted earnings per share $ 0.27 $ (1.72) $ (1.85)
============ =========== ==============
Weighted average number of shares
outstanding 70,901 70,284 70,284
============ =========== ==============
Weighted average common and dilutive
equivalent shares outstanding 72,518 70,284 70,284
============ =========== ==============
Operating statistics:
Gross margin as a percentage of sales 67.7% 64.3% 65.6%
Operating EBIT $ 32,043 $ 4,629 $ 3,669
Operating EBIT as a percentage of sales 14.9% 3.7% 3.3%
Net income from operations (after tax) $ 16,102 $ 3,513 $ 1,800
Operating earnings per share (basic) $ 0.23 $ 0.05 $ 0.03
Operating earnings per share (diluted) $ 0.22 $ 0.05 $ 0.03
</TABLE>
* 1998 Proforma shows the effects of removing the Diagnostic business activities
and assumes a 40% effective tax rate.
