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, 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 February 4, 1998:
MEDIMMUNE REPORTS PROFIT ON RECORD REVENUES
IN FOURTH QUARTER
Gaithersburg, MD, February 4, 1998 -- MedImmune, Inc. (Nasdaq:MEDI) today
reported basic earnings per share of $0.14 in fourth quarter 1997 compared
with a basic loss per share of $0.50 in fourth quarter 1996. Total revenues
for the quarter nearly tripled to $53.8 million from $18.0 million in fourth
quarter 1996.
"Fourth quarter 1997 was a remarkable period for MedImmune," commented Wayne
T. Hockmeyer, Ph.D., Chairman and Chief Executive Officer. "We reported a
profit on record revenues, entered into important strategic alliances with
Abbott Laboratories, Boehringer Ingelheim, and SmithKline Beecham, submitted
investigational new drug applications to begin clinical trials in psoriasis
and graft versus host disease with our novel antibody known as MEDI-507, and
submitted an application to the FDA requesting marketing clearance of
Synagis."
Synagis (palivizumab; previously identified as MEDI-493) is a humanized anti-
RSV monoclonal antibody. Respiratory syncytial virus (RSV) is the most
common cause of lower respiratory infections in infants and children.
For the fourth quarter ended December 31, 1997, total revenues of $53.8
million included RespiGam (Respiratory Syncytial Virus Immune Globulin
Intravenous (Human)) sales of $31.9 million, CytoGam (Cytomegalovirus Immune
Globulin Intravenous (Human)) sales of $6.4 million and other revenues of
$15.4 million compared with fourth quarter 1996 total revenues of $18.0
million which included RespiGam sales of $13.9 million, CytoGam sales of $3.8
million and other revenues of $0.3 million. Other revenues in fourth quarter
1997 consisted primarily of a $15.0 million license payment from Abbott
Laboratories (NYSE:ABT) associated with an alliance announced in December
1997 relating to Synagis. Cost of sales and other operating expenses in
fourth quarter 1997 were negatively affected by the establishment of certain
reserves. The Company reported diluted earnings per share in fourth quarter
1997 of $0.13 on 29.9 million shares and basic earnings per share in fourth
quarter 1997 of $0.14 per share on 24.4 million shares compared with a basic
and diluted loss per share in fourth quarter 1996 of $0.50 on 21.7 million
shares.
Subsequent to the close of fourth quarter 1997, the Company completed the
private placement of 1.7 million shares of common stock resulting in net
proceeds to the Company of $66.3 million. In addition, upon closing the
previously announced alliance with SmithKline Beecham (NYSE:SBH) relating to
the Company's HPV vaccine technology, the Company received a $15.0 million
payment and also completed the sale of 83,410 shares of common stock to
SmithKline Beecham resulting in net proceeds to the company of $5.0 million.
For the full year ended December 31, 1997, total revenues of $81.0 million
included RespiGam sales of $45.0 million, CytoGam sales of $20.3 million and
other revenues of $15.7 million compared with 1996 total revenues of $41.1
million which included RespiGam sales of $17.3 million, CytoGam sales of
$18.4 million and other revenues of $5.3 million. For the full year, the
Company reported a net loss of $36.9 million or basic and diluted loss per
share of $1.59 on 23.1 million shares compared with a net loss of $29.5
million or basic and diluted loss per share of $1.41 in 1996 on 21.0 million
shares. The increase was primarily attributed to increased co-promotion
expenses to American Home Products (NYSE:AHP) due to higher RespiGam sales,
increased manufacturing start-up costs and increased clinical costs
associated with completion of a Phase 3 clinical trial for Synagis.
Manufacturing start-up costs included costs associated with the start-up,
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 that continuing
manufacturing start-up charges will be incurred throughout 1998 and 1999.
Cash and marketable securities at December 31, 1997 were $50.3 million.
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 expects to file a supplement to its Synagis
Biologic License Application for additional manufacturing capacity utilizing
Boehringer Ingelheim's facility in Biberach, Germany. Product manufactured
by Boehringer Ingelheim will be required to launch Synagis, if and when
approved by regulatory authorities. MedImmune cautions that there can be no
assurance that Synagis will be licensed for marketing by regulatory
authorities or that product can be successfully manufactured at the
Boehringer Ingelheim facility. 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>
<CAPTION>
MEDIMMUNE, INC.
SELECTED FINANCIAL INFORMATION
(in thousands, except per share date)
CONDENSED STATEMENTS OF OPERATIONS
Three Months Ended
Year Ended
December 31,
December 31,
1997 1996
1997<F1> 1996
Unaudited
<S> <C> <C> <C> <C> <C>
Revenues: $ 38,340 $ 17,696 $ 65,271 $ 35,782
Product sales 15,417 262 15,693 5,317
Other --------- --------- --------- ---------
53,757 17,958 80,964 41,099
--------- --------- --------- ---------
Costs and expenses:
Cost of sales 20,530 8,632 34,433 19,678
Research and development 7,386 12,133 40,669 32,192
Selling, administrative and 14,364 8,563 31,735 22,165
general
Other operating expenses 7,825 ---- 11,543 ----
--------- --------- --------- ---------
50,105 29,328 118,380 74,035
--------- --------- --------- ---------
Interest (expense) income, net (358) 596 521 3,392
--------- --------- --------- ---------
Net earnings (loss) $ 3,294 $(10,774) $(36,895) $(29,544)
========= ========= ========= =========
Basic earnings (loss) per share $ 0.14 $ (0.50) $ (1.59) $ (1.41)
========= ========= ========= =========
Shares used in computing
basic earnings (loss) per 24,373 21,725 23,132 21,019
share
========= ========= ========= =========
Diluted earnings (loss) per $ 0.13 $ (0.50) $ (1.59) $ (1.41)
share
========= ========= ========= =========
Shares used in computing
diluted earnings (loss) per 29,944 21,725 23,132 21,019
share
========= ========= ========= =========
CONDENSED BALANCE SHEETS
December December
31, 31,
1997 1996
Assets:
Cash and marketable $ 50,326 $ 114,765
securities
Trade and contract 18,300 10,287
receivables, net
Inventory, net 28,857 6,060
Property and equipment, net 65,254 29,087
Other assets 7,599 3,772
---------- ----------
$ 170,336 $ 163,971
========== ==========
Liabilities and shareholders'equity:
Accounts payable $ 4,535 $ 3,942
Accrued expenses 27,682 10,509
Long term debt 85,363 70,874
Other liabilities 12,220 5,781
Shareholders' equity 40,536 72,865
---------- ----------
$ 170,336 $ 163,971
========== ==========
Common shares outstanding 24,445 21,837
========== ==========
<FN>
<F1> Certain 1997 amounts have been reclassified to conform with the current
presentation.
</FN>
</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) February 6, 1998
