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 25, 1997
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.
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 23, 1997:
MEDIMMUNE REPORTS FIRST HALF 1997 RESULTS
Gaithersburg, MD, July 23, 1997 -- MedImmune, Inc. (Nasdaq:MEDI) today
reported product sales for the first six months ended June 30, 1997
increased to $16.4 million from $13.5 million in the first six months of
1996. The increase is primarily attributable to increased sales of
RespiGam (Respiratory Syncytial Virus Immune Globulin Intravenous
(Human)), the Company's polyclonal antibody product to prevent RSV
pneumonia and bronchiolitis in high-risk infants (please see full
prescribing information).
Total second quarter 1997 revenues were $6.4 million with a net loss of
$12.2 million or $0.55 per share on 22.3 million shares compared to
second quarter 1996 revenues of $6.9 million with a net loss of $7.0
million or $0.33 per share on 21.4 million shares. Research and
development expenses increased in second quarter 1997 to $10.6 million
from $6.8 million in second quarter 1996, principally reflecting
increased clinical research expenses relating to MedImmune's 1,502-
patient Phase 3 clinical trial evaluating the ability of the Company's
monoclonal antibody, MEDI-493, to prevent respiratory syncytial virus
disease in high-risk infants. The Company recently announced positive
results of this trial and, based on these results, intends to file a
Biologic License Application by year end to request licensure by the
U.S. Food and Drug Administration. At June 30, 1997, MedImmune had cash
and marketable securities of $63.9 million.
"We are very pleased with the recently announced success of our Phase 3
trial for MEDI-493," said Wayne T. Hockmeyer, Ph.D., Chairman and Chief
Executive Officer of MedImmune. "Having now completed that study, we
expect research and development expenses in the second half to be
significantly lower than they were in the first half of 1997. We also
anticipate significant RespiGam sales will resume when the RSV season
begins again in the fourth quarter."
MedImmune is a biotechnology company focused on developing and marketing
products for the prevention and treatment of infectious diseases and
for use in transplantation medicine. RespiGam is a polyclonal antibody
product enriched in antibodies against respiratory syncytial virus
(RSV) used to prevent serious RSV disease, the leading cause of
bronchiolitis and pneumonia in certain high-risk children (please see
full prescribing information). RespiGam is manufactured by
Massachusetts Biologic Laboratories. MedImmune markets two products
through its hospital-based sales force and has six new product
candidates in clinical trials. MedImmune is located in Gaithersburg,
MD.
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, Inc.
Selected Financial Information
(in thousands, except per share data)
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
<TABLE>
<S> <C> <C> <C> <C>
Three Months Ended Six Months Ended
June 30, June 30,
================== ================
1997 1996 1997 1996
------- ------- ------- -------
Revenues:
Product sales $ 6,225 $ 6,830 $ 16,356 $ 13,454
Contracts 186 97 193 4,907
-------- -------- -------- --------
6,411 6,927 16,549 18,361
-------- -------- -------- --------
Costs and expenses:
Cost of sales 3,430 4,063 8,645 8,122
Research and development 10,573 6,849 23,941 12,242
Selling, administrative
and general 4,956 4,202 11,392 8,559
-------- -------- -------- --------
18,959 15,114 43,978 28,923
-------- -------- -------- --------
Interest income, net 339 1,147 898 1,954
-------- -------- -------- --------
Net loss $(12,209) $ (7,040) $(26,531) $ (8,608)
======== ======== ======== ========
Loss per share $ (0.55) $ (0.33) $ (1.20) $ (0.42)
======== ======== ======== ========
Shares used in computing
loss per share 22,319 21,386 22,097 20,340
======== ======== ======== ========
</TABLE>
CONDENSED BALANCE SHEETS
<TABLE>
<S> <C> <C>
June 30, Dec. 31,
1997 1996
-------- --------
unaudited
Assets:
Cash and marketable securities $ 63,893 $114,765
Trade and contract receivables, net 7,323 10,287
Inventory, net 15,959 6,060
Property and equipment, net 51,634 29,087
Other assets 5,032 3,772
-------- --------
$143,841 $163,971
======== ========
Liabilities and shareholders' equity:
Accounts payable $ 1,141 $ 3,942
Accrued expenses 12,939 10,509
Long term debt 76,759 70,874
Other liabilities 5,927 5,781
Shareholders' equity 47,075 72,865
-------- --------
$143,841 $163,971
======== ========
Common shares outstanding 23,767 21,837
======== ========
</TABLE>
SIGNATURE
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 thereunto duly authorized.
MEDIMMUNE, INC.
Registrant)
Date: July 25, 1997 /s/ David M. Mott
President and Chief Operating Officer
(Principal financial and
accounting officer)
