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: April 28, 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 releases dated April 23 and 24, 1997.
MEDIMMUNE REPORTS PRODUCT SALES INCREASE 53 PERCENT DURING FIRST
QUARTER 1997
Gaithersburg, MD, April 23, 1997 -- MedImmune, Inc. (Nasdaq:MEDI) today
reported product sales for the quarter ended March 31, 1997 increased
53 percent to $10.1 million from $6.6 million in first quarter 1996.
CytoGam (Cytomegalovirus Immune Globulin Intravenous (Human)) sales
increased 20 percent in first quarter 1997 to $5.0 million from $4.2
million in first quarter 1996. RespiGam (Respiratory Syncytial Virus
Immune Globulin Intravenous (Human)) sales increased 109 percent in
first quarter 1997 to $5.2 million from $2.5 million in first quarter
1996. Supply constraints limited RespiGam sales in first quarter 1997.
Total first quarter 1997 revenues were $10.1 million with a net loss of
$14.3 million or $0.65 per share on 21.9 million shares compared to
first quarter 1996 revenues of $11.4 million with a net loss of $1.6
million or $0.08 per share on 19.3 million shares. Research and
development expenses increased in first quarter 1997 to $13.4 million
from $5.4 million in first quarter 1996, principally reflecting
increased clinical research expenses primarily due to MedImmune's 1,502-
patient, placebo-controlled Phase 3 clinical trial evaluating the
ability of MEDI-493 to prevent respiratory syncytial virus disease in
certain infants. First quarter 1996 total revenues included a one-time
$4.5 million research payment to MedImmune from American Home Products
Corporation.
Selling, administrative and general expenses increased to $6.4 million
in first quarter 1997 from $4.4 million in first quarter 1996 related
primarily to: 1) increased sales and marketing expenses due to the full
quarter of sales force costs in first quarter 1997 as well as increased
marketing costs associated with the full launch of RespiGam and 2)
increased expenses associated with construction of MedImmune's
manufacturing facility in Frederick, Maryland. At March 31, 1997,
MedImmune had cash and marketable securities of $93.0 million.
"The Company greatly appreciates the patience of our customers and the
efforts of our sales force in helping to minimize the impact of our
RespiGam supply constraints during the first quarter," commented David
M. Mott, President and Chief Operating Officer of MedImmune. "We
continue to work with the product's manufacturer, Massachusetts
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
capability to provide additional production capacity beyond that
available at Massachusetts Biologic Laboratories."
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 (please see full prescribing information). CytoGam and
RespiGam are manufactured by Massachusetts Biologic Laboratories.
MedImmune markets CytoGam and RespiGam 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 the requirement for licensure by the FDA of the
Frederick Manufacturing Center as well as other risks and uncertainties
discussed in the Company's filings with the U.S. Securities and
Exchange Commission. CytoGam and RespiGam are registered trademarks of
MedImmune, Inc.
- Table Follows -
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
<TABLE>
<S> <C> <C>
Three Months
Ended March 31,
1997 1996
--------- ---------
Revenues:
Product sales $10,131 $ 6,624
Contracts 7 4,810
--------- ---------
10,138 11,434
--------- ---------
Costs and expenses:
Cost of sales 5,215 4,059
Research and development 13,368 5,393
Selling, administrative and 6,436 4,357
general
--------- ---------
25,019 13,809
--------- ---------
Interest income, net 559 807
--------- ---------
Net loss $(14,322) $ (1,568)
========= =========
Loss per share $ (0.65) $ (0.08)
========= =========
Shares used in computing loss per 21,874 19,294
share
========= =========
</TABLE>
Condensed Balance Sheets
<TABLE>
<S> <C> <C>
March 31, December 31,
1997 1996
------------- ---------------
Assets:
Cash and marketable securities $ 92,968 $ 114,765
Trade and contract receivables, net 7,838 10,287
Inventory, net 8,998 6,060
Property and equipment, net 41,536 29,087
Other assets 4,233 3,772
--------- ---------
$ 155,573 $ 163,971
========= =========
Liabilities and shareholders' equity:
Accounts payable $ 3,175 $ 3,942
Accrued expenses 16,277 10,509
Long term debt 73,245 70,874
Other liabilities 3,891 5,781
Shareholders' equity 58,985 72,865
--------- ---------
$ 155,573 $ 163,971
========= =========
Common shares outstanding 21,902 21,837
========= =========
</TABLE>
MEDIMMUNE ANNOUNCES CANDIDATE VACCINE PREVENTS
URINARY TRACT INFECTIONS
-- Results of Animal Studies Presented in Today's Science --
Gaithersburg, MD, April 24, 1997 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced that a candidate vaccine was able to prevent urinary
tract infections (UTIs) in mice. UTIs, caused by the bacterium
Escherichia coli (E. coli), create a significant medical problem which
result in 7-8 million physician and hospital visits per year at a cost
of greater than $1 billion. The results presented in today's Science
demonstrate the potential effectiveness of this vaccine against a broad
range of E. coli strains. MedImmune's research team, led by Solomon
Langermann, Ph.D., is developing its candidate vaccine for human use in
collaboration with the laboratories of Scott Hultgren, Ph.D., at
Washington University School of Medicine in St. Louis and Staffan
Normark, M.D., Ph.D., at the Karolinska Institute in Stockholm, Sweden.
"UTIs are among the most common infections for which individuals, women
in particular, seek medical care," commented Thomas M. Hooton, M.D.,
Associate Professor of Medicine at the University of Washington School
of Medicine. "UTIs range from sporadic bladder infections to frequent
recurrent bladder infections to potentially dangerous infections of the
kidneys. A preventative vaccine would be an exciting advancement in
controlling these diseases and the results presented in today's Science
provide a strong scientific basis for the development of such a
vaccine."
Currently there are no vaccines to prevent UTIs. Most infections can
be treated with antibiotics, however recurrence is common and emerging
antibiotic resistant bacteria create an additional threat. Earlier
attempts to use pili, the hair-like protein appendages on the surface
of bacteria, as vaccine targets were not successful in protecting
against a broad range of pathogenic bacteria, including E. coli, due to
the variation in the major component of the pili. The identification
of specific proteins, or "adhesins", at the end of pili which
facilitate the attachment of E. coli to human tissue, provided a novel
target for vaccine development. MedImmune's vaccine strategy is based
on blocking the disease-causing bacteria from binding and accumulating
in the bladder. The novel target of MedImmune's vaccine candidate is
the FimH adhesin. FimH does not vary widely among the different
strains of E. coli which cause UTIs and therefore provides an ideal
vaccine candidate. The Company is currently conducting vaccination
studies in monkeys with the Karolinska Institute in Sweden and hopes to
move forward with human clinical evaluation during 1998.
The article in Science is titled, "Prevention of Mucosal Escherichia
coli Infection by FimH-Adhesin-Based Systemic Vaccination" (Vol. 276,
pp. 607-611). The conclusions by MedImmune and its collaborators at
Washington University outlined in the publication are as follows:
- - FimH is required for infection: The E. coli UTI clinical isolate
NU14, containing FimH, bound to the surface of mouse and human
bladder tissue in vitro; a FimH deletion strain was unable to bind.
- - FimH antibodies block a broad range of E. coli strains: Antibodies
generated to FimH blocked the ability of E. coli (94% of the
isolates tested, 49/52) to bind to human bladder cells in vitro.
- - Vaccination with FimH protects: Mice immunized with the FimH
vaccine were protected from challenge with the bacteria (both
active and passive challenge); greater than 99% reduction of
bladder bacteria was shown for the entire length of the study (29
weeks).
"This is the first experimental demonstration that an adhesin-based
vaccine is effective," commented Solomon Langermann, Ph.D., Director,
Department of Immunology and Molecular Genetics at MedImmune and lead
author on the publication. "Our discoveries represent significant
progress towards a novel vaccination strategy which has initially shown
promise for UTIs and may be applicable for combating other bacterial
diseases as well."
UTIs are a significant medical problem and one of the most common
disorders prompting medical attention in otherwise healthy women and
children. It is estimated that by age 30 roughly 50 percent of women
have had at least one infection and 2-10 percent are affected by
recurrent infections. Females are generally more prone to UTIs simply
due to their anatomy. Recent studies have shown that, on average,
women who are 18-40 years old get 1-2 infections over a two year
period. Older adults are also at risk with the incidence as high as 33
out of 100 people.
Adhesin-based vaccines may be an effective strategy applicable to many
other diseases which are caused by organisms that express pilus-
associated adhesins, such as otitis media, pneumonia, meningitis and
gonorrhea. MedImmune has ongoing efforts in this area of basic
discovery.
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. MedImmune currently
markets two products through its hospital-based sales force and has six
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. Successful
development of a urinary tract vaccine will require several phases of
clinical evaluation and will be subject to regulatory approval from
authorities like the FDA in the U.S. There can be no assurance that
such approvals will be obtained.
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: April 28, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and
accounting officer)
