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: October 20, 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 office (Zip Code)
Registrant's telephone number, including area code (301) 417-0770
No Exhibits are being filed with this report
CytoGam, RespiGam and Synagis are registered trademarks of the Company.
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MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated October 20, 1999:
FOR IMMEDIATE RELEASE
MEDIMMUNE REVENUES DOUBLE IN 1999 THIRD QUARTER
Third Quarter Highlights
o Revenues Total $48.9 Million
o Earnings Per Diluted Share Reach $0.08 ($0.10 Before One-Time Item)
o Sales of Synagis Total $24.4 Million
Gaithersburg, MD, October 20, 1999 -- MedImmune, Inc. (Nasdaq: MEDI) today
reported that revenues more than doubled in the 1999 third quarter from the 1998
third quarter. Total revenues of $48.9 million in the 1999 third quarter
included product sales of $32.2 million and $16.7 million in other revenues,
including a $15 million milestone payment from Abbott Laboratories (NYSE: ABT)
for the European approval of Synagis (palivizumab) in August. Total revenues of
$23.8 million in the 1998 third quarter included $22.2 million in product sales
and $1.7 million of other revenues. Sales of Synagis in the 1999 third quarter
totaled $24.4 million, a 43-percent increase over the $17.0 million in sales of
Synagis reported in the 1998 third quarter. In the 1999 quarter, international
sales of Synagis totaled $2.3 million. Synagis is marketed for the prevention of
serious respiratory syncytial virus (RSV) disease in pediatric patients at high
risk for RSV disease, a seasonal affliction that typically runs from October
through April in the United States (see full prescribing information at
www.medimmune.com/products/synagispi.htm). The drug was launched in the United
States in September 1998.
"We are enthused to be starting the second RSV season with Synagis available to
help prevent serious RSV disease in high-risk children," said Wayne T.
Hockmeyer, Ph.D., chairman and chief executive officer. "In preparing for the
start of the RSV season, our sales and marketing organization, in conjunction
with the Ross Products Division of Abbott Laboratories, was busy during the
third quarter educating doctors, nurses and other caregivers on the benefits of
using Synagis, as well as implementing reimbursement programs that should make
it more financially convenient for doctors to provide the drug to appropriate
patients. We also recently initiated a direct-to-consumer advertising campaign
aimed at parents of high-risk children with the intent to increase their
understanding of RSV disease and encourage discussion of RSV with their
pediatricians. We believe our programs will help us build upon the successes
experienced during the first season of Synagis sales."
Additional Third Quarter Results
Net earnings for the 1999 third quarter were $5.1 million, or $0.08 per diluted
share, compared to a net loss of $11.1 million, or $0.21 per share, in the 1998
third quarter. Excluding one-time expenses associated with the pending
acquisition of U.S. Bioscience, Inc. (Amex: UBS), net earnings for the 1999
third quarter would have been $6.5 million, or $0.10 per diluted share.
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Gross margins of 66 percent in the 1999 quarter reflect increased reserves for
CytoGam Medicaid rebates compared to the 69 percent gross margin in the 1998
third quarter. Selling, general and administrative costs rose to $18.3 million
in the 1999 third quarter from $14.3 million in 1998 third quarter, due to costs
associated with the intended acquisition of U.S. Bioscience, Inc. and higher
promotion-related expenses for Synagis. Research and development expenses
increased to $10.2 million in third quarter 1999 from $5.8 million in third
quarter 1998 due to a larger number of active clinical trials. Other operating
expenses decreased to $4.4 million in third quarter 1999 from $8.5 million in
third quarter 1998, reflecting increased production activity for Synagis at
MedImmune's new manufacturing facility in Frederick, Maryland.
Cash and marketable securities at September 30, 1999 increased to $159.3 million
from $134.9 million at December 31, 1998, primarily reflecting cash provided by
operations.
Nine-Month Results
For the nine-month period ending September 30, 1999, MedImmune reported revenues
of $187.9 million, a 74-percent increase over the first nine months of 1998 when
revenues totaled $107.8 million. Revenues in the 1999 period were primarily
comprised of $141.9 million in sales of Synagis and $22.3 million of sales of
CytoGam (Cytomegalovirus Immune Globulin Intravenous (Human)). In the 1998
period, revenues included $32.3 million in sales of RespiGam (Respiratory
Syncytial Virus Immune Globulin Intravenous(Human)), $23.8 million in sales of
CytoGam, and $17.0 million in sales of Synagis. As expected since its launch in
the third quarter of 1998, Synagis has largely replaced RespiGam in the
marketplace, causing the shift in revenues.
Net earnings for the first nine months of 1999 were $23.6 million, or $0.37 per
diluted share, compared to a net loss of $16.4 million, or $0.31 per share in
the first nine months of 1998. Gross margins for the nine-month period improved
to 72 percent in 1999 from 40 percent in 1998, primarily reflecting the shift in
product mix to Synagis, which has a higher profit margin than CytoGam and
RespiGam. Selling, general and administrative expenses for the first nine months
of 1999 rose to $65.2 million from $30.4 million in the same period in 1998,
primarily reflecting increased promotional and co-promotional expenses related
to Synagis. Research and development costs increased 48 percent in the 1999
period to $27.8 million from $18.8 million in the first three quarters of 1998
due to the initiation of additional clinical studies for Synagis and other
development-stage compounds. Other expenses for the 1999 nine-month period were
$16.3 million, a decrease of 51 percent from the previous year when other
operating expenses totaled $33.4 million.
Other Third Quarter Activities
"During the third quarter, we focused a great deal of attention on growing our
business," commented Dr. Hockmeyer. "We acquired rights to a new catalytic
antibody that we think could eventually have potential in the treatment of
cocaine overdose and addiction. We announced our agreement to acquire U.S.
Bioscience, a biotechnology company with a strong focus in the cancer market. We
also announced the European approval of Synagis, raising the number of countries
that have now approved our drug to 24 worldwide. Several more international
applications are pending and our partner, Abbott International, is busy rolling
out the appropriate programs to advance this product in the various targeted
markets. As you can see, our activities in the third quarter have added
substantially to the growth of our business by expanding our reach into new
markets, diversifying our pipeline, and broadening our horizons into new
therapeutic specialties."
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o The anti-cocaine catalytic antibody, which was exclusively licensed from
Columbia University, is in preclinical research. Over the next two years,
MedImmune expects to humanize and optimize the antibody before moving into
human clinical testing.
o On October 12, 1999, MedImmune and U.S. Bioscience filed an S-4
Registration Statement related to MedImmune's pending acquisition of U.S.
Bioscience. Under the terms of the agreement, MedImmune will acquire all of
U.S. Bioscience's outstanding shares in a tax-free, stock-for-stock merger
that is intended to be accounted for as a pooling-of-interests transaction.
MedImmune hopes to complete the transaction later this year.
o Synagis is now approved in Argentina, Austria, Australia, Belgium, Brazil,
Colombia, Denmark,Finland, France, Germany, Greece,Ireland, Italy, Kuwait,
Luxembourg, Mexico, Netherlands, New Zealand, Portugal, Spain, Sweden,
United Kingdom, United States, and Uruguay. It is also available under
special permit in Chile. Currently, the product is available in all those
countries listed above, but at varying degrees of commercial rollout in
regards to reimbursement and pricing that must be handled differently in
each country.
Synagis is a humanized monoclonal antibody marketed for the prevention of
serious lower respiratory tract disease caused by respiratory syncytial virus in
pediatric patients at high risk of RSV disease (see full prescribing information
at www.medimmune.com/products/synagispi.htm). CytoGam is an intravenous immune
globulin enriched in antibodies against cytomegalovirus (CMV) and is marketed
for the attenuation of primary CMV disease in donor-positive/recipient-negative
kidney transplant patients (see full prescribing information at
www.medimmune.com/products/cytopi1.htm). RespiGam is an intravenous immune
globulin enriched in antibodies against RSV and is marketed 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 (see full prescribing
information at www.medimmune.com /pro-ducts /resppi.htm).
MedImmune, located in Gaithersburg, Maryland, is a biotechnology company focused
on developing and marketing products that address medical needs in areas such as
infectious disease, transplantation medicine, autoimmune disorders and cancer.
MedImmune markets three products through its hospital-based sales force and has
five 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. The FDA is
currently reviewing a supplement to MedImmune's Biologic License Application to
allow production of Synagis at its Frederick manufacturing facility. No
assurance can be given that the FDA will approve the plant to supply Synagis.
The company has recently filed an S-4 Registration Statement related to its
pending acquisition of U.S. Bioscience. There can be no assurance that this
acquisition will close, or that if it closes, no assurance can be given that
MedImmune will integrate the operations of the two companies without
encountering difficulties, including possible unanticipated costs, failure to
retain key U.S. Bioscience employees, or the diversion of management attention.
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.
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- Table Follows -
<TABLE>
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
- ----------------------------------------------
Three Months Ended Nine Months Ended
September 30, September 30,
1999 1998* 1999 1998*
<S> <C> <C> <C> <C>
--------- --------- --------- ---------
Revenues:
Product sales $ 32,201 $ 22,181 $ 167,397 $ 73,224
Contracts 16,710 1,659 20,474 34,545
--------- --------- --------- ---------
48,911 23,840 187,871 107,769
--------- --------- --------- ---------
Costs and expenses:
Cost of sales 10,828 6,903 46,649 43,661
Research and development 10,214 5,766 27,849 18,761
Selling, administrative and general 18,315 14,286 65,230 30,430
Other operating expenses 4,429 8,509 16,313 33,447
--------- --------- --------- ---------
43,786 35,464 156,041 126,299
--------- --------- ---------- ---------
Interest income, net 1,788 572 4,718 2,115
--------- --------- --------- ---------
Income (loss) before income taxes 6,913 (11,052) 36,548 (16,415)
Provision for income taxes 1,774 -- 12,935 --
--------- --------- --------- ---------
Net earnings (loss) $ 5,139 $ (11,052) $ 23,613 $ (16,415)
========= ========= ========= =========
Basic earnings (loss) per share $ 0.08 $ (0.21) $ 0.41 $ (0.31)
========== ========= ========= =========
Shares used in computing basic
earnings (loss) per share 62,890 53,310 58,041 52,754
========= ========= ========= =========
Diluted earnings (loss) per share $ 0.08 $ (0.21) $ 0.37 $ (0.31)
========= ========= ========= =========
Shares used in computing
diluted earnings (loss) per share 67,036 53,310 66,213 52,754
========= ========= ========= =========
Condensed Balance Sheets
- ------------------------
September 30, December 31,
1999 1998
--------- ---------
unaudited
<S> <C> <C>
Assets:
Cash and marketable securities $ 159,310 $ 134,882
Trade and contract receivables, net 23,711 34,837
Inventory, net 28,673 24,709
Deferred taxes, net 108,806 77,518
Property and equipment, net 81,575 74,822
Other assets 14,333 6,352
--------- ---------
$ 416,408 $ 353,120
========= =========
Liabilities and shareholders' equity:
Accounts payable $ 4,189 $ 4,052
Accrued expenses 24,358 33,397
Long term debt 19,695 85,892
Other liabilities 10,822 19,947
Shareholders' equity 357,344 209,832
--------- --------
$ 416,408 $ 353,120
========= ========
Common shares outstanding 63,278 54,655
========= ========
</TABLE>
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*Prior year share and per share amounts have been restated to give effect for
the 2 for 1 stock split on December 31, 1998.
SIGNATURES
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 hereunto duly authorized.
MEDIMMUNE, INC.
----------------
(Registrant)
Signed By /s/David M. Mott
October 21, 1999 David M. Mott, Vice Chairman and
Chief Financial Officer
