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 1, 1999
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 and Synagis is
a trademark.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated January 27, 1999:
MEDIMMUNE REPORTS RECORD YEAR
Synagis Sales Reach $110 million for 1998
Gaithersburg, MD, January 27, 1999 -- MedImmune, Inc. (Nasdaq: MEDI) today
reported that total revenues for the quarter ended December 31, 1998
increased 73 percent to $92.9 million from $53.8 million in the quarter ended
December 31, 1997. Total revenues in fourth quarter 1998 included net
product sales of $92.8 million for Synagis(palivizumab) and $9.2 million for
CytoGam (Cytomegalovirus Immune Globulin Intravenous (Human)). Total
revenues were offset by $12.5 million for an estimate of potential returns of
RespiGam (Respiratory Syncytial Virus Immune Globulin Intravenous (Human))
which now is obsolete because of the launch of Synagis. Total revenues for
the year ended December 31, 1998, including $109.7 million for sales of
Synagis, increased 148 percent to $200.7 million from $81.0 million for the
1997 year.
Reported earnings for fourth quarter 1998 were $72.7 million or $1.13 per
share on a diluted basis on 64.4 million shares compared with earnings in
fourth quarter 1997 of $3.3 million or $0.06 per share on a diluted basis on
59.9 million shares. Reported earnings for the full year 1998 were $56.2
million or $0.91 per share on a diluted basis on 63.4 million shares compared
with a loss in the full year 1997 of $36.9 million or $0.80 per share on a
basic and diluted basis on 46.3 million shares. On December 31, 1998, cash
and marketable securities were $134.9 million compared with $100.4 million on
September 30, 1998 primarily reflecting positive cash flow from operations.
Results in fourth quarter 1998 included two adjustments: 1) a $47.4 million
tax benefit reflecting the reversal of a valuation allowance for net
operating loss and research and development tax credit carry forwards now
expected to be realized and 2) the $12.5 million RespiGam return estimate
described above. Excluding these two items, earnings for fourth quarter 1998
would have been $37.7 million or $0.59 per share on a diluted basis, and for
the 1998 year would have been $21.3 million or $0.37 per share on a diluted
basis.
The Synagis launch has exceeded even our own expectations and we believe we
are well on our way to making this one of the most successful biotech product
launches ever," commented Wayne T. Hockmeyer, Ph.D., Chairman and Chief
Executive Officer. Our successes in 1998 go beyond Synagis and encompass all
areas of the business. We continue to see growth in sales of our first
product CytoGam, we have made excellent progress in our R&D pipeline, we have
maintained tight control over operating costs and we closed the year with the
strongest balance sheet in the history of MedImmune. We are grateful to our
employees, partners and shareholders for their contributions to our success
and look forward to an outstanding 1999.
For fourth quarter 1998, net sales of Synagis were $92.8 million compared
with no Synagis sales in fourth quarter 1997 because Synagis was approved for
marketing and launched in 1998. Sales of Synagis totaled $109.7 million
since they commenced September 15, 1998. Net sales of CytoGam in fourth
quarter 1998 increased 43 percent to $9.2 million from $6.4 million in fourth
quarter 1997 primarily reflecting strong international sales. Net sales of
RespiGam, which were $31.9 million in fourth quarter 1997, were negative
$12.5 million in fourth quarter 1998 because of the estimate for returns
reflecting obsolescence of RespiGam following the introduction of Synagis.
Other revenues decreased 82 percent to $2.7 million in fourth quarter 1998
from $15.4 million in fourth quarter 1997 primarily because of a $15.0
million payment in fourth quarter 1997 from Abbott Laboratories relating to
the Synagis alliance, offset partly by R&D reimbursement from SmithKline
Beecham (SB) in fourth quarter 1998 pursuant to the human papillomavirus
vaccine alliance.
In fourth quarter 1998, gross margins improved to 71 percent from 46 percent
in fourth quarter 1997. Excluding the effect of the estimate for RespiGam
returns, gross margins would have been 74 percent in fourth quarter 1998.
In fourth quarter 1998, sales, general and administration expenses increased
to $31.6 million from $14.4 million in fourth quarter 1997. The increase,
primarily related to the launch of Synagis, included increased selling and
marketing expenses, as well as a co-promotion commission to Abbott accrued in
accordance with the threshold-based co-promotion agreement between MedImmune
and Abbott for sale of Synagis in the United States.
In fourth quarter 1998, other operating expenses decreased to $3.0 million
from $7.8 million in fourth quarter 1997 primarily because of one-time
payments to third parties in fourth quarter 1997 to provide additional
production capacity for Synagis. Other operating expenses in fourth quarter
1998 are primarily related to manufacturing start-up costs associated with
MedImmune's new manufacturing facility located in Frederick, Maryland.
Synagis is a humanized monoclonal antibody which was approved for marketing
in June 1998 by the U.S. Food and Drug Administration (FDA) for the
prevention of serious lower respiratory tract disease caused by RSV in
pediatric patients at high risk of RSV disease (please see full prescribing
information attached and at www.medimmune.com/products/synagispi.htm).
Synagis is the first monoclonal antibody to be licensed for any infectious
disease. Synagis is administered by intramuscular injection once per month
during anticipated periods of RSV prevalence in the community. RSV is the
most common cause of pneumonia and bronchiolitis in infants and children. In
the Northern Hemisphere, the RSV season typically commences in November and
lasts through April but it may begin earlier or persist later in certain
communities.
CytoGam is an intravenous immune globulin enriched in antibodies against
cytomegalovirus (CMV) and is marketed by MedImmune in the United States for
the prophylaxis against CMV disease associated with transplantation of
kidney, lung, liver, pancreas, and heart (please see full prescribing
information attached and at www.medimmune.com/products/cytopi1.htm).
RespiGam is an intravenous immune globulin enriched in antibodies against 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 was 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 attached and at
www.medimmune.com/products/resppi.htm).
MedImmune, located in Gaithersburg, Maryland, 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
markets three products through its hospital-based sales force and has four
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. MedImmune 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
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations
<TABLE>
<CAPTION>
Three Months Ended Year Ended
December 31 December 31,
--------------------- ----------------------
Unaudited
1998 1997* 1998 1997*
---------- ---------- --------- ----------
<S> <C> <C> <C> <C>
Revenues:
Product sales $ 90,216 $ 38,340 $ 163,440 $ 65,271
Other 2,723 15,417 37,268 15,693
---------- ---------- --------- ----------
92,939 53,757 200,708 80,964
---------- ---------- --------- ----------
Cost and expenses:
Cost of sales 26,575 20,530 70,236 34,433
Research and development 7,014 7,386 25,775 40,669
Selling, administrative
and general 31,578 14,364 62,008 31,735
Other operating expenses 3,048 7,825 36,495 11,543
---------- ---------- --------- ----------
68,215 50,105 194,514 118,380
---------- ---------- --------- ----------
Interest income, net 503 (358) 2,618 521
---------- ---------- --------- ----------
Income (loss) before
income taxes 25,227 3,294 8,812 (36,895)
Income tax benefit 47,428 - 47,428 -
---------- ---------- --------- ----------
Net earnings (loss) $ 72,655 $ 3,294 $ 56,240 $ (36,895)
======== ======== ======== ========
Basic earnings (loss) per
share $ 1.34 $ 0.07 $ 1.06 $ (0.80)
======== ======== ======== ========
Shares used in computing
basic earnings (loss) per
share 54,231 48,747 53,130 46,264
======== ======== ======== ========
Diluted earnings (loss)
per share $ 1.13 $ 0.06 $ 0.91 $ (0.80)
======== ======== ======== ========
Shares used in computing
basic earnings (loss) per
share 64,409 59,887 63,401 46,264
======== ======== ======== ========
</TABLE>
Condensed Balance Sheets
<TABLE>
<CAPTION>
December 31, December 31,
1998 1997*
---------- ---------
<S> <C> <C>
Assets:
Cash and marketable securities $ 134,882 $ 50,326
Trade and contract receivables net 34,837 18,300
Inventory, net 24,709 31,303
Deferred taxes, net 77,518 -
Property and equipment, net 74,822 65,254
Other assets 6,352 5,153
---------- ---------
$ 353,120 $ 170,336
========= =========
Liabilities and shareholders' equity:
Accounts payable $ 4,052 $ 4,535
Accrued expenses 33,397 27,682
Other liabilities 19,947 9,934
Long term debt 85,892 87,649
Shareholders' equity 209,832 40,536
---------- ---------
$ 353,120 $ 170,336
========= =========
Common shares outstanding 54,655 48,889
========= =========
</TABLE>
*Prior year share and per share amounts have been restated to give effect for
the for the 2 for 1 stock split on December 31, 1998.
(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 1, 1999
