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 24, 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 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 July 22, 1998:
MEDIMMUNE REVENUES INCREASE OVER 400 PERCENT IN FIRST HALF
Gaithersburg, MD, July 22, 1998 -- MedImmune, Inc. (Nasdaq:MEDI) today reported
that revenues in the first half of 1998 increased over five-fold to $83.9
million from $16.5 million in the first half of 1997. The net loss in first
half 1998 decreased to $5.4 million, or $0.20 per share, from a net loss of
$26.5 million, or $1.20 per share, in first half 1997. The reported net loss in
1998 included two one-time charges in second quarter 1998 with net effect
totaling approximately $18 million related to buying down certain royalty
obligations for Synagis (palivizumab; previously identified as MEDI-493) and
reserving against certain inventories of RespiGam (Respiratory Syncytial Virus
Immune Globulin Intravenous (Human)).
"We are pleased with the continued growth of the business and look forward to
the launch of Synagis following its recent approval for marketing by the FDA,"
said Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive Officer. Dr.
Hockmeyer added that, "We believe the royalty buydown was a terrific opportunity
to invest in the future potential of Synagis and should result in improved gross
margins for the product. The RespiGam inventory reserve reflects the
anticipated shift in customer demand from RespiGam to Synagis and the resulting
obsolescence of this inventory."
For the second quarter ended June 30, 1998, total revenues increased to $24.6
million from $6.4 million in second quarter 1997. Product revenues for the
second quarter of $8.2 million included CytoGam (Cytomegalovirus Immune Globulin
Intravenous (Human)) and RespiGam revenues of $7.6 million and $0.5 million,
respectively, compared with CytoGam and RespiGam revenues of $5.3 million and
$1.0 million, respectively, for the second quarter 1997. Other revenues in
second quarter 1998 of $16.4 million consisted primarily of a $15.0 million
payment from Abbott Laboratories (NYSE:ABT) related to approval of Synagis and
research payments from SmithKline Beecham (NYSE:SBH) for MedImmune's HPV vaccine
program.
For second quarter 1998, MedImmune reported a net loss of $18.6 million or $0.70
per share compared to a net loss of $12.2 million or $0.55 per share for the
same period in 1997. Cost of sales in second quarter 1998 included a one-time
$10.5 million charge to reserve for certain RespiGam inventories including raw
materials purchased prior to Synagis approval. This reserve was partially offset
by reimbursement from American Home Products Corp. (NYSE:AHP) related to its
RespiGam co-promotion agreement with the Company. The decrease in selling,
general and administrative expenses, from $4.6 million in second quarter 1997 to
$3.2 million in second quarter 1998, primarily reflects that reimbursement.
Research and development expenses decreased to $7.3 million in second quarter
1998 from $10.6 million in second quarter 1997 primarily reflecting the
completion in third quarter 1997 of a Phase 3 clinical trial evaluating Synagis.
Other operating expenses increased to $19.1 million in second quarter 1998 from
$0.3 million in second quarter 1997. The increase is attributed to: (1) a
previously announced one-time $10.3 million buy-down of certain Synagis royalty
obligations to improve future gross margins; (2) manufacturing start-up costs
associated with the validation and licensure of MedImmune's new manufacturing
facilities; and (3) charges for the start-up of additional production capacity
for Synagis obtained from certain third parties. Cash and marketable securities
at June 30, 1998 were $131.0 million compared to $133.7 million at March 31,
1998 reflecting slightly negative cash flow from operations.
Synagis is a humanized monoclonal antibody 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 respiratory syncytial virus (RSV) in
pediatric patients at high risk of RSV disease (please see full prescribing
information 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 at 15 mg/kg and is given 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 October and lasts
through March or April.
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 at www.medimmune.com/products/resppi.htm).
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 at
www.medimmune.com/products/cytopi1.htm).
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 three products through its hospital-
based sales force and has four 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. The FDA is
currently reviewing a supplement to MedImmune's Biologic License Application to
allow production of Synagis at Boehringer Ingelheim's (BI's) manufacturing
facility. Supply from BI is expected to be required to meet market demand. No
assurance can be given that BI will be approved by the FDA to supply Synagis in
time for the RSV season or at all. 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
<TABLE>
<CAPTION>
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
- ---------------------------------------------------------------------------
Three Months Ended Six Months Ended June
June 30, 30,
---------------------- ---------------------
<S> <C> <C> <C> <C>
1998 1997* 1998 1997*
---------- ---------- ---------- ---------
Revenues:
Product sales $ 8,150 $ 6,225 $ 51,043 $ 16,356
Other 16,441 186 32,886 193
---------- ---------- ---------- ---------
24,591 6,411 83,929 16,549
---------- ---------- ---------- ---------
Costs and expenses:
Cost of sales 14,483 3,430 36,758 8,645
Research and development 7,327 10,573 12,995 23,941
Selling, administrative and 3,218 4,621 16,144 10,768
general
Other operating expenses 19,136 335 24,938 624
---------- ---------- ---------- ---------
44,164 18,959 90,835 43,978
---------- ---------- ---------- ---------
Interest income, net 1,005 339 1,543 898
---------- ---------- ---------- ---------
Net loss $(18,568) $(12,209) $ (5,363) $(26,531)
========== ========== ========== ==========
Net loss per share, basic and $ (0.70) $ (0.55) $ (0.20) $ (1.20)
diluted
========== ========== ========== ==========
Shares used in computing loss
per share, basic and diluted 26,527 22,319 26,234 22,097
========== ========== ========== ==========
*Certain amounts have been reclassified to conform with the current
presentation.
</TABLE>
<TABLE>
<CAPTION>
Condensed Balance Sheets
- --------------------------------------------------------------------------------
<S> <C> <C>
June 30, December 31,
1998 1997
------------ ------------
unaudited
Assets:
Cash and marketable securities $ 130,967 $ 50,326
Trade and contract receivables, net 1,973 18,300
Inventory, net 28,937 31,303
Property and equipment, net 67,319 65,254
Other assets 5,402 5,153
------------ ------------
$ 234,598 $ 170,336
============ ============
Liabilities and shareholders' equity:
Accounts payable $ 2,267 $ 4,535
Accrued expenses 26,939 27,682
Long term debt 87,235 87,649
Other liabilities 8,367 9,934
Shareholders' equity 109,790 40,536
------------ ------------
$ 234,598 $ 170,336
============ ============
Common shares outstanding 26,571 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) July 24, 1998
