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: February 6, 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 is a registered trademark and
RespiGam is a trademark 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 February 6, 1997.
MEDIMMUNE REPORTS PRODUCT SALES INCREASE 250 PERCENT FOR Q4 1996
-- Successful launch of new product to prevent
serious RSV disease in infants --
Gaithersburg, MD, February 6, 1997 -- MedImmune, Inc. (Nasdaq:MEDI)
today reported that product sales for the quarter ended December 31,
1996 increased 250 percent to $17.7 million from $5.1 million in 1995.
The increase was due principally to $13.9 million in sales of RespiGam
(Respiratory Syncytial Virus Immune Globulin Intravenous (Human)).
RespiGam was approved for marketing in January 1996 for prevention of
serious lower respiratory tract infection caused by respiratory
syncytial virus (RSV) in children under 24 months of age with
bronchopulmonary dysplasia or a history of premature birth (i.e., less
than or equal to 35 weeks gestation; please see full prescribing
information).
"Initial demand for RespiGam has confirmed both the medical need and
market potential for this product," commented David M. Mott, President
and Chief Operating Officer of MedImmune. "We have been in a back
order situation since before year end and are currently working with
our customers to allocate the supply of product which will be available
during the remainder of the 1996/1997 RSV season. We are working with
the product's manufacturer, Massachusetts Public Health Biologic
Laboratories, to ensure that an adequate supply of RespiGam will be
available for future RSV seasons. Progress continues on construction
of our own manufacturing facility which would have the potential to
provide additional production capacity beyond that available at
Massachusetts Public Health Biologic Laboratories."
Total 1996 revenues were $41.1 million with a net loss of $29.5 million
or $1.41 per share on 21.0 million shares, compared to 1995 revenues of
$27.4 million and a net loss of $22.7 million or $1.41 per share on
16.1 million shares. Product sales in 1996 increased 121 percent to
$35.8 million including RespiGam sales of $17.3 million and CytoGam
(Cytomegalovirus Immune Globulin Intravenous (Human)) sales of $18.4
million. The 14 percent increase in CytoGam sales represents the
fourth consecutive year of double-digit sales growth for MedImmune's
first product. For fourth quarter 1996, MedImmune had total revenues
of $18.0 million and a net loss of $10.8 million, or $0.50 per share on
21.7 million shares compared to fourth quarter 1995 revenues of $7.0
million and a net loss of $8.6 million or $0.49 per share on 17.4
million shares. MedImmune had cash and marketable securities of $114.8
million at December 31, 1996.
The net loss in the fourth quarter 1996 increased to $10.8 million from
$8.6 million in fourth quarter 1995. Excluding one-time charges in
1995, the increase was primarily attributable to 1) increased cost of
sales partially offset by better overall gross margins, 2) increased
selling, administrative and general expenses, principally associated
with supporting the launch of RespiGam and 3) increased research and
development expenditures. The increased research and development
expenses are primarily due to the commencement of a 1,503-patient Phase
3 clinical trial of MEDI-493, MedImmune's second generation product
being evaluated for the prevention of serious RSV disease. The Company
expects clinical trial expenses for MEDI-493 to remain high through the
first half of 1997 and then to decrease significantly in the second
half of 1997 following completion of the Phase 3 trial.
RSV is the leading cause of pneumonia and bronchiolitis in infants.
RSV outbreaks occur worldwide during the late fall, winter and early
spring. In the United States alone, over 90,000 children are
hospitalized and 4,500 die from RSV disease annually. Premature
infants and children who suffer from a chronic lung condition known as
bronchopulmonary dysplasia (BPD) are at increased risk for acquiring
severe RSV disease. Each year approximately 100,000 of these children
are at the highest risk for developing serious RSV disease.
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. CytoGam and RespiGam
are polyclonal antibody products enriched in antibodies against
cytomegalovirus (CMV) and respiratory syncytial virus (RSV),
respectively. CytoGam is used for attenuation of primary CMV disease
associated with kidney transplantation (please see full prescribing
information), and RespiGam is used to prevent serious RSV disease, the
leading cause of bronchiolitis and pneumonia in certain high-risk
children. CytoGam and RespiGam are manufactured by Massachusetts Public
Health Biologic Laboratories. MedImmune markets CytoGam and RespiGam
through its hospital-based sales force and has seven 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.
- Table Follows -
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
<TABLE>
<S> <C> <C> <C> <C>
Three Months Year ended
Ended December 31, December 31,
1996 1995 1996 1995
--------- --------- --------- ---------
(unaudited)
Revenues:
Product sales $ 17,696 $ 5,052 $ 35,782 $ 16,173
Contracts 262 1,933 5,317 11,263
--------- --------- --------- ---------
17,958 6,985 41,099 27,436
--------- --------- --------- ---------
Costs and expenses:
Cost of sales 8,632 2,915 19,678 10,678
Research and development 12,133 5,893 32,192 26,417
Selling, administrative 8,563 4,550 22,165 11,719
and general
Other operating expenses -- 2,700 -- 2,700
--------- --------- --------- ---------
29,328 16,058 74,035 51,514
--------- --------- --------- ---------
Interest income, net 596 483 3,392 1,407
--------- --------- --------- ---------
Net loss $(10,774) $ (8,590) $(29,544) $(22,671)
========= ========= ========= =========
Loss per share $ (0.50) $ (0.49) $ (1.41) $ (1.41)
========= ========= ========= =========
Shares used in computing loss 21,725 17,431 21,019 16,061
per share
========= ========= ========= =========
</TABLE>
Condensed Balance Sheets
<TABLE>
<S> <C> <C>
December 31, December 31,
1996 1995
------------- -------------
Assets:
Cash and marketable securities $ 114,765 $ 38,039
Trade and contract receivables, net 10,287 3,897
Inventory, net 6,060 6,027
Property and equipment, net 29,087 8,255
Other assets 3,772 1,114
--------- ---------
$ 163,971 $ 57,332
========= =========
Liabilities and shareholders' equity:
Accounts payable $ 3,942 $ 2,318
Accrued expenses 10,509 6,538
Long term debt 70,874 1,984
Other liabilities 5,781 2,713
Shareholders' equity 72,865 43,779
--------- ---------
$ 163,971 $ 57,332
========= =========
Common shares outstanding 21,837 17,706
========= =========
</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: February 6, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
