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 24, 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 October 22, 1997:
MEDIMMUNE REPORTS PRODUCT SALES INCREASE 128 PERCENT
IN THIRD QUARTER
Gaithersburg, MD, October 22, 1997 -- MedImmune, Inc. (Nasdaq:MEDI) today
reported that product sales in the third quarter 1997 increased 128 percent
to $10.6 million from $4.6 million in the third quarter 1996. The increase
is primarily attributable to sales of RespiGam (Respiratory Syncytial Virus
Immune Globulin Intravenous (Human)) which increased from $0.5 million in the
third quarter 1996 to $7.0 million in the third quarter 1997.
"Demand for RespiGam for the 1997/1998 RSV season began earlier and is
stronger than we had expected. We are gratified by the enthusiastic response
of our customers and we are working to insure the broadest availability of
product for this season," commented Wayne T. Hockmeyer, Ph.D., Chairman and
Chief Executive Officer. Dr. Hockmeyer added that, "As the RSV season
reaches full force, we expect RespiGam sales to further increase in fourth
quarter 1997."
Third quarter 1997 total revenues were $10.7 million with a net loss of $13.7
million or $0.57 per share on 23.9 million shares compared to third quarter
1996 total revenues of $4.8 million with a net loss of $10.2 million or $0.47
per share on 21.7 million shares. Cost of sales increased to $5.3 million in
third quarter 1997 from $2.9 million in third quarter 1996 reflecting
increased unit volume partially offset by decreased cost per unit. Research
and development expenses increased to $9.3 million from $7.8 million,
primarily reflecting $1.3 in license payments associated with humanized
monoclonal antibodies, including the previously announced license with
Protein Design Labs. Selling, administrative and general expenses increased
to $6.6 million in third quarter 1997 from $5.0 million in third quarter 1996
primarily reflecting increased co-promotion expenses to American Home
Products Corporation (NYSE:AHP) for RespiGam due to increased sales of the
product.
The third quarter operating loss included other operating expenses of $3.1
million which primarily reflect manufacturing start-up costs. Manufacturing
start-up costs include costs associated with the start-up, validation and
licensure of MedImmune's new manufacturing facilities as well as payments to
certain contract manufacturers working with the Company to provide
supplemental commercial production capacity for MEDI-493 (palivizumab).
MedImmune expects additional manufacturing start-up charges will be incurred
throughout the remainder of 1997 and 1998.
MEDI-493 is a humanized monoclonal antibody which has been evaluated in a
Phase 3 double-blind, placebo-controlled clinical trial for its ability to
prevent respiratory syncytial virus (RSV) disease in high-risk infants. The
Company expects by year end to submit to the FDA a Biologic License
Application requesting marketing clearance of MEDI-493 in the United States.
The Company also plans to submit applications in 1998 requesting marketing
authorization in Europe and Canada.
RespiGam, a polyclonal antibody product enriched in antibodies against RSV,
is licensed for the prevention of serious RSV disease in certain high-risk
children (please see full prescribing information). RSV is the most common
cause of lower respiratory infections in infants and children worldwide. RSV
outbreaks typically occur during the late fall, winter and early spring.
Healthy children and individuals with adequate immune systems often acquire a
benign chest cold when infected with RSV. In contrast, premature infants and
children with BPD are at increased risk for acquiring severe RSV disease
(pneumonia and bronchiolitis), often requiring hospitalization. In the
United States alone, over 90,000 children are hospitalized and 4,500 die from
RSV disease annually. The cost of treating a high-risk child hospitalized
for RSV can be over $70,000.
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 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 cautions that there can be no assurance that
MEDI-493 will be licensed for marketing by regulatory authorities.
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,
------------------ -----------------
1997 1996 1997<F1> 1996
--------- --------- -------- ---------
<S> <C> <C> <C> <C> <C>
Revenues:
Product sales $ 10,575 $ 4,632 $ 26,931 $ 18,086
Contracts 84 148 277 5,055
--------- --------- --------- ---------
10,659 4,780 27,208 23,141
--------- --------- --------- ---------
Costs and expenses:
Cost of sales 5,258 2,924 13,903 11,046
Research and development 9,342 7,817 33,283 20,059
Selling, admin and general 6,603 5,043 17,371 13,602
Other operating expenses 3,094 -- 3,718 --
--------- --------- --------- ---------
24,297 15,784 68,275 44,707
--------- --------- --------- ---------
Interest income, net (19) 842 879 2,796
--------- --------- --------- ---------
Net loss $(13,657) $(10,162) $(40,188) $(18,770)
========= ========= ========= =========
Loss per share $ (0.57) $ (0.47) $ (1.77) $ (0.90)
========= ========= ========= =========
Shares used in computing 23,938 21,656 22,718 20,782
loss per share
========= ========= ========= =========
<FN>
<F1>Certain 1997 amounts have been reclassified to conform with the current
presentation.
</FN>
</TABLE>
CONDENSED BALANCE SHEETS
<TABLE>
<CAPTION>
September 30, December 31,
1997 1996
------------ -------------
unaudited
<S> <C> <C>
Assets:
Cash and marketable securities $ 30,788 $114,765
Trade and contract receivables, net 11,432 10,287
Inventory, net 28,793 6,060
Property and equipment, net 60,711 29,087
Other assets 4,356 3,772
------------ ------------
$136,080 $163,971
============ ============
Liabilities and shareholders' equity:
Accounts payable $ 4,358 $ 3,942
Accrued expenses 14,634 10,509
Long term debt 76,292 70,874
Other liabilities 4,740 5,781
Shareholders' equity 36,056 72,865
------------ ------------
$136,080 $163,971
============ ============
24,137 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.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, President and Chief Operating Officer
(Principal financial and accounting officer)
(DATE) October 24, 1997
