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 23, 1998
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 April 22, 1998:
MEDIMMUNE POSTS RECORD FIRST QUARTER SALES AND EARNINGS
Gaithersburg, MD, April 22, 1998 -- MedImmune, Inc. (Nasdaq:MEDI) today
reported net income for the quarter ended March 31, 1998 of $13.2 million or
$0.44 per share on a diluted basis compared to a net loss of $14.3 million or
$0.65 per share on a diluted basis for the same period in 1997. Total
revenues for the quarter increased nearly six-fold to $59.3 million from
$10.1 million in first quarter 1997. In first quarter 1998, sales of
RespiGam (Respiratory Syncytial Virus Immune Globulin Intravenous (Human))
increased more than six-fold to $32.1 million from $5.2 million in first
quarter 1997 and sales of CytoGam (Cytomegalovirus Immune Globulin
Intravenous (Human)) in the quarter more than doubled to $10.8 million from
$5.0 million in first quarter 1997.
"The Company is very pleased with the sales performance of our two marketed
products," commented Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive
Officer. "The 523 percent increase in RespiGam sales reflects strong demand
for the product and our success in increasing product supply over the last
year to meet this demand. We are gratified by the contribution RespiGam is
making in the fight to prevent serious RSV disease in high risk infants."
Dr. Hockmeyer added that "the recent increase in the demand for CytoGam
reflects both the impact of recent marketing initiatives as well as product
substitution resulting from the current shortage of non-specific intravenous
immune globulin products."
For the quarter ended March 31, 1998, total revenues of $59.3 million
included other revenues of $16.4 million compared with a negligible amount of
other revenues during first quarter 1997. Other revenues in first quarter
1998 consisted primarily of a $15.0 million payment from SmithKline Beecham
(NYSE:SBH) associated with initiation of an alliance announced in December
1997 relating to MedImmune's HPV vaccine candidates. The financial results
for the first quarter 1998 do not include a provision for income taxes
because of the existence of $159 million in net operating loss carry
forwards.
Research and development expenses decreased to $5.7 million in first quarter
1998 from $13.4 million in first quarter 1997 primarily reflecting the
completion in third quarter 1997 of a Phase 3 clinical trial evaluating
Synagis (palivizumab). Selling, general and administrative expenses
increased to $12.9 million in first quarter 1998 from $6.1 million in first
quarter 1997 primarily attributed to increased co-promotion payments to
American Home Products (NYSE:AHP) due to higher RespiGam sales. Other
operating expenses increased to $5.8 million in first quarter 1998 from $0.3
million in first quarter 1997. The increase was attributed to manufacturing
start-up costs associated with the validation and licensure of MedImmune's
new manufacturing facilities as well as payments to certain third parties
working with the Company to provide additional production capacity for
Synagis. MedImmune expects further manufacturing start-up charges will be
incurred throughout 1998 and 1999.
Cash and marketable securities at March 31, 1997 were $133.7 million
reflecting: (1) the private placement during the quarter of 1.7 million
shares of common stock resulting in net proceeds to the Company of $66.3
million; (2) completion during the quarter of the sale of 83,410 shares of
common stock to SmithKline Beecham in connection with the companies' HPV
vaccine alliance for net proceeds to the Company of $5.0 million; and (3)
positive cash flow from operations.
CytoGam is an intravenous immune globulin enriched in antibodies against
cytomegalovirus (CMV) and is marketed by MedImmune in the United States for
the attenuation of primary CMV disease in donor-positive / recipient-negative
kidney transplant patients (please see full prescribing information).
RespiGam is an intravenous immune globulin enriched in antibodies against
respiratory syncytial virus (RSV) and is marketed by MedImmune in the United
States for the prevention of serious lower respiratory tract infection caused
by RSV in children under 24 months of age with BPD or a history of premature
birth (i.e., less than or equal to 35 weeks gestation). RespiGam is the first
product demonstrated to be safe and effective in reducing the incidence and
duration of RSV hospitalization and severity of RSV illness in these high-
risk infants (please see full prescribing information). RSV is the most
common cause of pneumonia and bronchiolitis in infants and children.
Synagis is a humanized monoclonal antibody which binds to a protein on the
surface of RSV. A Phase 3 clinical trial evaluating Synagis as a potential
agent to prevent serious RSV disease in high-risk infants has been completed
and a Biologic License Application including these data was submitted to the
FDA in December, 1997.
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 and CytoGam are manufactured by
Massachusetts Biologic Laboratories. MedImmune markets two products through
its hospital-based sales force and has five 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 cannot predict the extent or duration of the
intravenous immune globulin supply shortage. No assurances can be given that
the Company will receive clearance by the FDA to market Synagis, or, if such
clearance is received, that it will be received in a timely manner.
MedImmune also cautions that RSV disease occurs primarily during the winter
months; the Company believes its operating results will reflect that
seasonality for the foreseeable future.
Table Follows
<TABLE>
<CAPTION>
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
- ------------------------------------------------------------------
Three Months Ended March 31,
---------------------------
<S> <C> <C>
1998 1997*
-------- --------
Revenues:
Product sales $ 42,893 $ 10,131
Other 16,445 7
-------- --------
59,338 10,138
-------- --------
Costs and expenses:
Cost of sales 22,275 5,215
Research and development 5,668 13,368
Selling, administrative and general 12,926 6,147
Other operating expenses 5,802 289
-------- --------
46,671 25,019
-------- --------
Interest income, net 538 559
-------- --------
Net earnings (loss) $ 13,205 $ (14,322)
======== ========
Basic earnings (loss) per share $ 0.51 $ (0.65)
======== ========
Shares used in computing
basic earnings (loss) per share 25,944 21,874
======== ========
Diluted earnings (loss) per share $ 0.44 $ (0.65)
======== ========
Shares used in computing
diluted earnings (loss) per share 31,577 21,874
======== ========
* Certain amounts have been reclassified to conform with the current
year presentation
</TABLE>
<TABLE>
<CAPTION>
Condensed Balance Sheets
- ------------------------------------------------------------------
<S> <C> <C>
March 31, December 31,
1998 1997
-------- --------
unaudited
Assets:
Cash and marketable securities $ 133,683 $ 50,326
Trade and contract receivables, net 21,123 18,300
Inventory, net 31,448 31,303
Property and equipment, net 66,286 65,254
Other assets 5,862 5,153
-------- --------
$ 258,402 $ 170,336
======== ========
Liabilities and shareholders' equity:
Accounts payable $ 5,501 $ 4,535
Accured expenses 28,551 27,682
Long term debt 87,133 87,649
Other liabilities 9,700 9,934
Shareholders' equity 127,517 40,536
-------- --------
$ 258,402 $ 170,336
======== ========
Common shares outstanding 26,509 24,445
======== ========
</TABLE>
(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) April 23, 1998
