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
Date of Report: July 23, 1999
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 52-1555759
(State of Incorporation) (I.R.S. Employer
Identification No.)
35 West Watkins Mill Road, Gaithersburg, MD 20878
(Address of principal executive office (Zip Code)
Registrant's telephone number, including area code (301) 417-0770
No Exhibits are being filed with this report
CytoGam and RespiGam are registered trademarks of the Company and Synagis is a
trademark.
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MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated July 21, 1999:
FOR IMMEDIATE RELEASE
Contact:
William C. Roberts
Investor and Media Relations
MedImmune, Inc.
301-417-0770 x358
http://www.medimmune.com
MEDIMMUNE REPORTS 1999 FIRST HALF RESULTS
Gaithersburg, MD, July 21, 1999 -- MedImmune, Inc. (Nasdaq: MEDI) today reported
that total revenues in the first six months of 1999 were $139.0 million, an
increase of 66 percent compared with revenues of $83.9 million in the first half
of 1998. Net earnings for the first half of 1999 were $18.5 million, or $0.29
per share on a diluted basis, compared to a loss of $5.4 million, or $0.10 per
share, in the first half of 1998. The increase in revenues in the first half of
1999 is primarily attributable to sales of Synagis (palivizumab), the Company's
humanized monoclonal antibody approved for the prevention of serious lower
respiratory tract disease caused by respiratory syncytial virus (RSV) in
pediatric patients (please see full prescribing information at
http://www.medimmune.com/products/synagispi.htm).
Product sales for second quarter included revenue from CytoGam (Cytomegalovirus
Immune Globulin Intravenous (Human)) of $5.5 million, revenue from Synagis of
$1.3 million and other product sales of $1.4 million. Product sales in second
quarter of 1998 were $7.6 million for CytoGam and $0.6 million for other
products. Other revenues for both quarters included research funding from
SmithKline Beecham (NYSE:SBH) for MedImmune's HPV vaccine program and second
quarter 1998 included a $15 million payment from Abbott Laboratories (NYSE: ABT)
received upon U.S. Food and Drug Administration (FDA) approval of Synagis.
Cost of sales was $4.6 million for second quarter 1999 compared to $14.5 million
in the 1998 quarter. Cost of sales in second quarter 1998 included a one-time
$10.5 million charge for certain RespiGam inventories including raw materials
purchased prior to Synagis approval. Research and development spending increased
to $8.9 million in second quarter 1999 from $7.3 million in second quarter 1998
primarily due to increased clinical spending for MEDI-507 and additional Synagis
trials. Selling, administrative and general expenses increased to $9.9 million
in second quarter of 1999 from $3.2 million in the 1998 quarter, reflecting
overall spending increases in this area as well as reimbursement in 1998 from
American Home Products Corp. (NYSE:AHP) under the terms of the RespiGam
(Respiratory Syncytial Virus Immune Globulin Intravenous (Human)) co-promotion
agreement. Excluding the effect of a one-time charge of $10.3 million in June
1998 for buying down certain Synagis royalty obligations, other operating
expenses decreased to $6.0 million in second quarter 1999 from $8.8 million in
1998.
The net loss in second quarter 1999 was $10.4 million or $0.19 per share on 56.0
million shares compared to a loss of $18.6 million or $0.35 per share on 53.1
million shares in second quarter 1998. Second quarter 1999 included a benefit of
$7.0 million for income taxes; no tax benefit was recorded in second quarter
1998. Cash and marketable securities at June 30, 1999 were $184.2 million
compared to $134.9 million at December 31, 1998 reflecting positive cash flow
from operations. Subsequent to the quarter, in early July 1999, the Company
converted its seven percent convertible subordinated notes into 6.1 million
shares of common stock. This had the effect of reducing long term debt and
increasing shareholders' equity by approximately $60 million.
"We continue to be very pleased with our financial results as well as with the
growth and development of our business," said Wayne T. Hockmeyer, Ph.D.,
Chairman and Chief Executive Officer. "Having completed one of the most
successful biotech product launches in the U.S. ever during this past RSV
season, this quarter our attention and the attention of our partners at Abbott
Laboratories turned to the international marketplace. During second quarter we
received a positive opinion from the European Committee for Proprietary
Medicinal Products, which we hope to translate into a marketing authorization
for Europe later this year. We have now received approvals in nine countries and
filed for approval in 43. Also during the second quarter, our partners at Abbott
began a clinical trial in Japan which we hope will put us in a position to file
for marketing approval in that market next year."
Dr. Hockmeyer added, "Progress continues in other areas of the business as well.
During the second quarter, our manufacturing and regulatory groups achieved
another milestone with the submission of a supplement to our Biologic License
Application requesting authorization from the FDA to begin marketing Synagis
produced at our manufacturing facility in Frederick, Maryland. We are also on
track to submit Investigational New Drug Applications to the FDA to begin
clinical trials with two new vaccines later this year."
Synagis is a humanized monoclonal antibody which was approved for marketing in
June 1998 by the U.S. Food and Drug Administration for the prevention of serious
lower respiratory tract disease caused by RSV in pediatric patients at high risk
of RSV disease. Synagis is the first monoclonal antibody to be licensed for any
infectious disease. Synagis is administered by intramuscular injection once per
month during anticipated periods of RSV prevalence in the community. RSV is the
most common cause of pneumonia and bronchiolitis in infants and children. In the
Northern Hemisphere, the RSV season typically commences in November and lasts
through April but it may begin earlier or persist later in certain communities.
CytoGam is an intravenous immune globulin enriched in antibodies against
cytomegalovirus (CMV) and is marketed by MedImmune in the United States for the
prophylaxis against CMV disease associated with transplantation of kidney, lung,
liver, pancreas, and heart (please see full prescribing information attached and
at www.medimmune.com/products/cytopi1.htm).
RespiGam is an intravenous immune globulin enriched in antibodies against RSV
and is marketed by MedImmune in the United States for the prevention of serious
lower respiratory tract infection caused by RSV in children under 24 months of
age with bronchopulmonary dysplasia (BPD) or a history of premature birth
(please see full prescribing information attached and at
www.medimmune.com/products/resppi.htm).
MedImmune, located in Gaithersburg, Maryland, is a biotechnology company focused
on developing and marketing products that address medical needs in areas such as
infectious disease, transplantation medicine, autoimmune disorders and cancer.
MedImmune markets three products through its hospital-based sales force and has
five new product candidates in clinical trials.
This announcement may contain, in addition to historical information, certain
forward-looking statements that involve risks and uncertainties. Such statements
reflect management's current views and are based on certain assumptions. Actual
results could differ materially from those currently anticipated as a result of
a number of factors, including risks and uncertainties discussed in the
Company's filings with the U.S. Securities and Exchange Commission. The FDA is
currently reviewing a supplement to MedImmune's Biologic License Application to
allow production of Synagis at its Frederick manufacturing facility. No
assurance can be given that the FDA will approve the plant to supply Synagis.
MedImmune cautions that RSV disease occurs primarily during the winter months;
the Company believes its operating results will reflect that seasonality for the
foreseeable future.
-Table Follows-
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MedImmune, Inc.
Selected Financial Information (Unaudited)
(in thousands, except per share data)
Condensed Statements of Operations
<TABLE>
<S> <C> <C>
Three Months Ended June 30, Six Months Ended June 30,
--------------------------- ------------------------
1999 1998* 1999 1998*
---- ----- ---- -----
Revenues:
Product Sales $ 8,200 $ 8,150 $ 135,196 $ 51,043
Other 2,039 16,441 3,764 32,886
--------- --------- --------- ---------
10,239 24,591 138,960 83,929
--------- --------- --------- ---------
Costs and expenses:
Cost of sales 4,554 14,483 35,821 36,758
Research and development 8,852 7,327 17,635 12,995
Selling, admin. & gen 9,866 3,218 46,915 16,144
Other operating expenses 6,016 19,136 11,884 24,938
--------- --------- --------- ---------
29,288 44,164 112,255 90,835
--------- --------- --------- ---------
Interest income, net 1,671 1,005 2,930 1,543
--------- --------- --------- ---------
(Loss) income before income tax (17,378) (18,568) 29,635 (5,363)
(Benefit) provisionfor income taxes (7,017) -- 11,161 --
--------- --------- --------- ---------
Net (loss) earnings $ (10,361) $ (18,568) $ 18,474 $ (5,363)
========= ========= ========= =========
Basic (loss) earnings per share $ (0.19) $ (0.35) $ .33 $ (0.10)
========= ========= ========= =========
Shares used in computing(loss) earnings per share 55,972 53,054 55,570 52,469
========= ========= ========= =========
Diluted (loss) earnings per share $ (0.19) $ (0.35) $ 0.29 $ (0.10)
========= ========= ========= =========
Shares used in computing diluted (loss) earnings
per share 55,972 53,054 65,682 52,469
========= ========= ========= =========
MedImmune, Inc.
Condensed Balance Sheets June 30, Dec. 31,
1999 1998
--------- ---------
Assets:
Cash and marketable securities $184,232 $134,882
Trade and contract receivables, net 2,274 34,837
Inventory, net 20,983 24,709
Deferred taxes, net 95,801 77,518
Property and equipment, net 77,265 74,822
Other assets 15,281 6,352
-------- --------
$395,836 $353,120
======== ========
Liabilities and shareholders' equity:
Accounts payable $ 2,072 $ 4,052
Accrued expenses 20,954 33,397
Long-term debt 82,903 85,892
Other liabilities 17,286 19,947
Shareholders' equity 272,621 209,832
-------- --------
$395,836 $353,120
======== ========
Common shares outstanding 56,626 54,655
======== ========
*Prior year share and per share amounts have been restated to give effect for
the 2 for 1 stock split on December 31, 1998.
###
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(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) July 23, 1999
