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: May 19, 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.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated April 21, 1999:
FOR IMMEDIATE RELEASE
Contacts:
Mark E. Kaufmann William C. Roberts
MedImmune, Inc. MedImmune, Inc.
Director, Planning and Analysis Investor and Media Relations
301-417-0770 x321 301-417-0770 x358
http://www.medimmune.com
MEDIMMUNE FIRST QUARTER PRODUCT SALES NEARLY TRIPLE
- Synagis Launch Reaches $226 million in First Season -
Gaithersburg, MD, April 21, 1999 -- MedImmune, Inc. (Nasdaq: MEDI) today
reported net sales of Synagis (palivizumab) in first quarter 1999 of $116.2
million and total product sales of $127.0 million, nearly triple first
quarter 1998. Net sales of Synagis for the 1998/1999 respiratory syncytial
virus (RSV) season have been $225.9 million through March 31, 1999. Earnings
per share more than doubled to $0.45 per share, diluted and fully taxed, on
65.5 million shares in first quarter 1999 from $0.21 per share, diluted but
untaxed, on 63.2 million shares in first quarter 1998.
"The Synagis U.S. launch has been one of the most successful in the history
of biotech," said Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive
Officer. "We are pleased with the initial response to the product and
estimate that we reached 15 to 20 percent of the children who could
potentially benefit from Synagis in this first season. We are focused now on
expanding the usage of Synagis in the United States during next RSV season
and look forward to launching Synagis in markets outside the United States
through our partner at Abbott International during the next season as well.
We also continue to work to expand the market potential for Synagis through
ongoing clinical trials in additional patient populations."
Dr. Hockmeyer added that, "Beyond Synagis we continue to make excellent
progress with the development of our R&D pipeline, with five additional
product candidates currently in clinical trials and two new product
candidates expected to enter the clinic by the end of this year. While much
of the focus is currently on our commercial success with Synagis, it is
important to remember that our R&D base has also never been stronger."
Total revenues in first quarter 1999 increased 117 percent to $128.7 million
from $59.3 million in first quarter 1998. Revenues in first quarter 1999
included: 1) net product sales of $116.2 million for Synagis; 2) net product
sales of $9.7 million for CytoGam (Cytomegalovirus Immune Globulin
Intravenous (Human)); 3) net product sales of $1.1 million for RespiGam and
by-products resulting from the production of CytoGam and RespiGam; and 4)
$1.7 million for payments associated primarily with government research
grants and MedImmune's collaboration with SmithKline Beecham regarding
MedImmune's human papillomavirus (HPV) vaccine. Revenues in first quarter
1998 included: 1) net product sales of $32.1 million for RespiGam; 2) net
product sales of $10.8 million for CytoGam; and 3) $16.4 million for other
revenues including a $15 million up-front payment from SmithKline Beecham to
enter into the HPV collaboration. Since its launch in September 1998,
Synagis has largely replaced RespiGam in the marketplace, as expected by the
Company.
1
<PAGE>
In first quarter 1999, product gross margins improved to 75 percent from 48
percent in first quarter 1998 primarily because of product mix. Synagis has
higher product gross margins than RespiGam and CytoGam. In first quarter
1999, research and development expenses increased 55 percent to $8.8 million
from $5.7 million primarily because of increased development activities,
including additional clinical studies of Synagis. Selling, general and
administrative expenses increased to $37.0 million in first quarter 1999 from
$12.9 million in first quarter 1998 primarily because of the commission
charge to the Ross Products division of Abbott Laboratories to co-promote
Synagis, as well as the increased selling and marketing expenses associated
with the launch of Synagis.
Earnings in first quarter 1999 grew 118 percent to $28.8 million from $13.2
million in first quarter 1998. First quarter 1999 included a charge of $18.2
million for income taxes; no tax expense was recorded in first quarter 1998.
At March 31, 1999, cash and marketable securities had increased to $194.1
million compared with $134.9 million at December 31, 1998, primarily
reflecting positive cash flows from operations.
Synagis is a humanized monoclonal antibody which was approved for marketing
in June 1998 by the U.S. Food and Drug Administration (FDA) for the
prevention of serious lower respiratory tract disease caused by RSV in
pediatric patients at high risk of RSV disease (please see full prescribing
information attached and at www.medimmune.com/products/synagispi.htm).
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, a biotechnology company located in Gaithersburg, Maryland,
develops and markets 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.
2
<PAGE>
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. MedImmune cautions that RSV disease occurs primarily
during the winter months; the Company believes its operating results will
continue to reflect that seasonality for the foreseeable future.
Table Follows -
<PAGE>
<TABLE>
<CAPTION>
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
- ------------------------------------------------------------------
Three Months Ended March 31,
---------------------------
<S> <C> <C>
1999 1998*
-------- --------
Revenues:
Product sales $126,996 $ 42,893
Other 1,725 16,445
-------- --------
128,721 59,338
-------- --------
Costs and expenses:
Cost of sales 31,267 22,275
Research and development 8,783 5,668
Selling, administrative and general 37,049 12,926
Other operating expenses 5,868 5,802
-------- --------
82,967 46,671
-------- --------
Interest income, net 1,259 538
-------- --------
Income before income taxes 47,013 13,205
Provision for income taxes 18,178 -
-------- --------
Net earnings $ 28,835 $ 13,205
======== ========
Basic earnings per share $ 0.52 $ 0.25
======== ========
Shares used in computing
basic earnings per share 55,162 51,888
======== ========
Diluted earnings per share $ 0.45 $ 0.21
======== ========
Shares used in computing
Diluted earnings (loss) per share 65,468 63,155
======== ========
</TABLE>
3
<PAGE>
<TABLE>
<CAPTION>
Condensed Balance Sheets
- ----------------------------------------------------------------------
<S> <C> <C>
March 31, December 31,
1999 1998
--------- ---------
Unaudited
Assets:
Cash and marketable securities $194,054 $134,882
Trade and contract receivables, net 42,329 34,837
Inventory, net 21,475 24,709
Deferred, taxes, net 73,485 77,518
Property and equipment, net 76,249 74,822
Other assets 9,249 6,352
-------- --------
$416,841 $353,120
======== ========
Liabilities and shareholders' equity:
Accounts payable $ 2,045 $ 4,052
Accured expenses 48,877 33,397
Long term debt 83,534 85,892
Other liabilities 21,485 19,947
Shareholders' equity 260,900 209,832
-------- --------
$416,841 $353,120
======== ========
Common shares outstanding 55,623 54,655
======== ========
</TABLE>
*Prior year share and per share amounts have been restated to give effect for
the 2 for 1 stock split on December 31, 1998.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) May 19, 1999
4
<PAGE>
