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: October 9, 1998
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 offices) (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 October 21, 1998:
MEDIMMUNE REVENUES INCREASE NEARLY FOUR-FOLD
IN FIRST THREE QUARTERS OF 1998
Gaithersburg, MD, October 21, 1998 -- MedImmune, Inc. (Nasdaq: MEDI) today
reported that revenues for the nine months ended September 30, 1998 increased
nearly four-fold to $107.8 million from $27.2 million in the nine months ended
September 30, 1997. Total revenues of $23.8 million in third quarter 1998
included $17.0 million of Synagis (palivizumab; previously identified as MEDI-
493) product sales. Synagis, marketed by the Company for the prevention of
serious respiratory syncytial virus (RSV) disease in pediatric patients at high
risk for RSV disease, was launched in the U.S. in mid-September 1998.
"We are very pleased with the initial response of our customers, payors and the
medical community to the launch of Synagis," said Wayne T. Hockmeyer, Ph.D.,
Chairman and Chief Executive Officer. "We are grateful for the outstanding
efforts thus far by our own marketing and sales organization and by our partners
in the Ross Products Division of Abbott Laboratories (NYSE: ABT). Together with
our collaborators and partners, we take great pride in the contributions Synagis
is making in the fight to prevent serious RSV disease in high risk infants." Dr.
Hockmeyer added, "While we are off to an excellent start, a great deal of work
remains to insure a successful launch of Synagis.
For the quarter ended September 30, 1998, total revenues increased 124 percent
to $23.8 million from $10.7 million in the prior year's third quarter. Revenues
for third quarter included Synagis and CytoGam (Cytomegalovirus Immune Globulin
Intravenous (Human)) product sales of $17.0 million and $5.4 million,
respectively. In last year's third quarter, Synagis had yet to be launched and
thus produced no revenues while CytoGam produced revenues of $3.6 million.
RespiGam revenues during third quarter 1997 were $7.0 million and were not a
contributor to revenues during third quarter 1998, which reflects the
anticipated shift in customer demand from RespiGam to Synagis. Other revenues
in third quarter 1998 of $1.7 million consisted primarily of research payments
from SmithKline Beecham (NYSE: SBH) for MedImmune's HPV vaccine program.
For third quarter 1998, MedImmune reported a net loss of $11.1 million or $0.41
per share compared to a net loss of $13.7 million or $0.57 per share for the
same period in 1997. Gross margins improved to 69 percent from 50 percent in
the 1998 third quarter reflecting the lower costs to produce Synagis. The
increase in selling, general and administrative expenses, from $6.6 million in
third quarter 1997 to $14.3 million in third quarter 1998, primarily reflects
the co-promotion expense to Abbott Laboratories and increased marketing and
sales costs related to the launch of Synagis.
Research and development expenses decreased to $5.8 million in third quarter
1998 from $9.3 million in third quarter 1997. Higher research and development
expenses in 1997 primarily reflected additional payments made to third parties
to secure intellectual property rights for Synagis and for the Phase 3 clinical
study for Synagis. Other operating expenses increased to $8.5 million in third
quarter 1998 from $3.1 million in third quarter 1997. The increase is
attributed to manufacturing start-up costs associated with MedImmune's new
manufacturing facilities. Cash and marketable securities at September 30, 1998
were $100.4 million compared to $131.0 million at June 30, 1998.
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 respiratory syncytial virus
(RSV) in pediatric patients at high risk of RSV disease (please see full
prescribing information 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 October and lasts through
March or April.
CytoGam is an intravenous immune globulin enriched in antibodies against
cytomegalovirus (CMV) and is marketed by MedImmune in the United States for the
attenuation of primary CMV disease in donor-positive/recipient-negative kidney
transplant patients (please see full prescribing information 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 BPD or a history of premature birth (i.e., less than or equal to 35
weeks gestation). RespiGam was the first product demonstrated to be safe and
effective in reducing the incidence and duration of RSV hospitalization and
severity of RSV illness in these high-risk infants (please see full prescribing
information at www.medimmune.com/products/resppi.htm).
MedImmune, located in Gaithersburg, Maryland, is a biotechnology company focused
on developing and marketing products for the prevention and treatment of
infectious diseases and for use in transplantation medicine. MedImmune markets
three products through its hospital-based sales force and has four 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. 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.
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30,
---------------------- ----------------------
1998 1997 1998 1997
---------- ---------- ---------- --------
<S> <C> <C> <C> <C>
Revenues:
Product sales $ 22,181 $ 10,575 $ 73,224 $ 26,931
Contracts 1,659 84 34,545 277
---------- ---------- ---------- ---------
23,840 10,659 107,769 27,208
---------- ---------- ---------- ---------
Cost and expenses:
Cost of sales 6,903 5,258 43,661 13,903
Research and development 5,766 9,342 18,761 33,283
Selling, admin and general 14,286 6,603 30,430 17,371
Other operating expenses 8,509 3,094 33,447 3,718
---------- ---------- ---------- ---------
35,464 24,297 126,299 68,275
---------- ---------- ---------- ---------
Interest income, net 572 (19) 2,115 879
---------- ---------- ---------- ---------
Net loss $ (11,052) $ (13,657) $ (16,415) $(40,188)
========= ========= ========= =========
Loss per share, basic and $ (0.41) $ (0.57) $ (0.62) $ (1.77)
diluted
========= ========= ========= =========
Shares used in computing
loss per share, basic and 26,655 23,938 26,377 22,718
diluted
========= ========= ========= =========
</TABLE>
Condensed Balance Sheets
<TABLE>
<CAPTION>
September December
30, 31,
1998 1997
---------- ---------
unaudited
<S> <C> <C>
Assets:
Cash and marketable securities $ 100,350 $ 50,326
Trade and contract receivables, net 16,188 18,300
Inventory, net 28,570 31,303
Property and equipment, net 69,020 65,254
Other assets 5,528 5,153
---------- ---------
$ 219,656 $ 170,336
========= =========
Liabilities and shareholder's equity:
Accounts payable $ 2,580 $ 4,535
Accrued expenses 23,596 27,682
Long term debt 86,671 87,649
Other liabilities 6,553 9,934
Shareholders' equity $100,256 $ 40,536
---------- ---------
$219,656 $ 170,336
========= =========
Common shares outstanding 26,719 24,445
========= =========
</TABLE>
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) October 23, 1998
