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, 1996
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 51-1555759
(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
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained on the following press
release dated July 25, 1996.
MEDIMMUNE REPORTS RECORD PRODUCT SALES
Gaithersburg, MD, July 25, 1996 -- MedImmune, Inc. (Nasdaq:MEDI) today
reported that product sales for the six months ended June 30, 1996
increased 84 percent to $13.5 million from $7.3 million in the six months
ended June 30, 1995. Sales of CytoGam (Cytomegalovirus Immune Globulin
Intravenous (Human)) increased 43 percent in the first half 1996 to $10.5
million and sales of RespiGam (Respiratory Syncytial Virus Immune Globulin
Intravenous (Human)) were $3.0 million during the first half of 1996
following receipt of marketing approval on January 18, 1996. The full
launch of RespiGam is planned for fall 1996 in connection with the
commencement of the respiratory syncytial virus (RSV) season. Sales of
RespiGam are expected principally during the RSV season which typically
occurs from November through April.
Total revenues for the first half of 1996 increased to $18.4 million with a
net loss of $8.6 million or $0.42 per share on 20.3 million shares compared
to revenues of $13.8 million and a net loss of $10.3 million or $0.69 per
share on 15.0 million shares in the same period of 1995.
Product sales for the quarter ended June 30, 1996 increased 61 percent to
$6.8 million from $4.2 million in the second quarter 1995. Sales of
CytoGam increased 49 percent to $6.3 million for the quarter. Total second
quarter 1996 revenues were $6.9 million with a net loss of $7.0 million or
$0.33 per share on 21.4 million shares compared to 1995's second quarter
revenues of $7.9 million and net loss of $4.9 million or $0.32 per share on
15.4 million shares. At June 30, 1996, MedImmune had cash and marketable
securities of $81.1 million. Subsequent to the close of the quarter, on
July 8, 1996, a convertible subordinated note offering was completed for
additional net proceeds of $58 million.
"We are pleased to report record product sales for the second quarter and
for the first six months of 1996," commented David M. Mott, President and
Chief Operating Officer. "In addition to achieving 43 percent growth in
CytoGam sales, our sales and marketing group is making excellent progress
toward the full launch of RespiGam this fall. Of the largest 420 neonatal
and pediatric hospitals in the United States, 130 have added RespiGam to
their formularies and 111 protocols have been developed. Additionally, 40
of 51 state Medicaid programs have confirmed coverage and a number of the
largest health insurance plans in the United States have already approved
RespiGam for reimbursement."
Quarterly financial results may vary significantly due to seasonality of
RespiGam sales, research funding and expenditures for research, development
and marketing programs. In the third and fourth quarters of 1996, the
Company anticipates substantial increases in research and development
expenses, primarily reflecting costs of MEDI-493 and MEDI-500 clinical
trial programs. Production capacity may impose constraints on finished
product availability of CytoGam and RespiGam. The Company plans to
construct its own manufacturing facility to increase production capacity.
MedImmune, Inc. 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 cytomegalovirus (CMV) disease associated with
kidney transplantation, 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 currently markets two
products through its hospital-based sales force and has six new products 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 cannot predict the timing or outcome of
regulatory approval processes.
-- Table Follows --
<TABLE>
<CAPTION>
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
Three Months Six Months
Ended June 30, Ended June 30,
1996 1995 1996 1995
--------- --------- --------- ---------
<S> <C> <C> <C> <C>
Revenues
Product sales $ 6,830 $ 4,236 $ 13,454 $ 7,300
Contracts 97 3,624 4,907 6,487
--------- --------- --------- ---------
6,927 7,860 18,361 13,787
--------- --------- --------- ---------
Costs and expenses
Cost of sales 4,063 2,911 8,122 5,468
Research and development 6,849 7,991 12,242 14,559
Selling, administrative 4,202 2,138 8,559 4,658
and general
--------- --------- --------- ---------
15,114 13,040 28,923 24,685
Interest income, net 1,147 311 1,954 563
--------- --------- --------- ---------
Net loss $ (7,040) $ (4,869) $ (8,608) $(10,335)
========= ========= ========= =========
Loss per share $ (0.33) $ (0.32) $ (0.42) $ (0.69)
========= ========= ========= =========
Shares used in computing 21,386 15,436 20,340 15,029
loss per share
========= ========= ========= =========
</TABLE>
<TABLE>
<CAPTION>
Condensed Balance Sheets
June 30, 1996 December 31,1995
------------- ----------------
(unaudited)
<S> <C> <C>
Assets:
Cash and marketable securities $ 81,067 $ 38,039
Trade and contract receivables, net 7,573 3,919
Inventory, net 6,173 6,027
Property and equipment, net 10,445 8,255
Other assets 1,037 1,092
--------- ---------
$ 106,295 $ 57,332
========= =========
Liabilities and shareholders' equity
Accounts payable $ 1,367 $ 2,318
Accrued expenses 6,526 6,538
Other liabilities 4,708 4,697
Shareholders' equity 93,694 43,779
--------- ---------
$ 106,295 $ 57,332
========= =========
Common shares outstanding 21,655 17,706
========= =========
</TABLE>
NOTE: CytoGam is a registered trademark and
RespiGam is a trademark of the Company.
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, 1996 s/David M. Mott
President and Chief Operating Officer
Principal financial and accounting officer)