Recent Highlights
- Synagis(R) worldwide sales of $523 million increased 9 percent in first
six months of 2005 over the 2004 period
- Year-to-date earnings of $70 million, or $0.28 per diluted share
- Stock repurchase program accelerated during second quarter; $67 million
in stock repurchased in first six months of 2005
- Preliminary analysis of Phase 3 bridging study for FluMist(R) and CAIV-T
shows primary endpoint of comparable immunogenicity achieved
- Data from several FluMist and CAIV-T studies supporting broad protection
against influenza presented at the Pediatric Academic Societies' (PAS)
Annual Meeting
- Phase 1/2 study data for Numax(TM) presented at PAS Annual Meeting
showing acceptable safety profile
- Phase 2 data showing positive overall survival results for melanoma
patients treated with Vitaxin(R) presented at the American Society of
Clinical Oncology (ASCO) Annual Meeting
- Preliminary Phase 1 clinical trial results of siplizumab indicate the
antibody safe and well tolerated in patients with certain T-cell
lymphomas and leukemias presented at ASCO
- Preclinical data demonstrating a correlation between interleukin-9
(IL-9) and increased airway hyperreactivity presented at the Annual
International Conference of the American Thoracic Society
- Collaboration established with Avalon Pharmaceuticals to discover and
develop small molecules for inflammatory diseases
- MedImmune's scientific founders honored with 2005 Albert B. Sabin
Humanitarian Award for their contributions to creating innovative and
breakthrough advancements in medicine
GAITHERSBURG, Md., July 21 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that total revenues for the 2005 second quarter
were $88 million, including a 10-percent increase in sales of Synagis
(palivizumab) in the U.S. to $43 million. Worldwide sales of Synagis were $51
million in the 2005 second quarter, while worldwide sales of Ethyol(R)
(amifostine) totaled $23 million and Cytogam(R) (cytomegalovirus immune
globulin intravenous (human)) totaled $11 million. MedImmune's quarterly
results are heavily impacted by the seasonal use of two of its four marketed
products, Synagis and FluMist (Influenza Virus Vaccine Live, Intranasal), both
of which are prescribed to help prevent serious respiratory viruses that most
commonly occur in the fall and winter months. Total revenues in the 2004
second quarter were $94 million, which included $56 million of worldwide sales
from Synagis, $25 million from Ethyol, and $8 million from CytoGam. Sales of
Synagis outside the U.S. in the 2004 second quarter were $16 million,
reflecting earlier than normal stocking of inventories prior to the start of
the 2004-2005 respiratory syncytial virus season.
Total revenues in the first six months of 2005 grew to $598 million due to
a 9-percent increase in worldwide sales of Synagis to $523 million. In the
first six months of 2005, sales of Ethyol were $45 million and sales of
CytoGam were $22 million. Total revenues in the 2004 period were $583 million
due to $478 million in worldwide sales of Synagis, $49 million in sales of
Ethyol, and $18 million in sales of CytoGam.
"In the second quarter, we continued to execute on our 2005 objectives,"
commented David M. Mott, president and chief executive officer. "We made
significant clinical progress with the completion of the influenza vaccine
bridging study and with the preparatory steps required for unblinding the
Phase 3 efficacy trial results with the investigational, next-generation
refrigerator stable formulation influenza vaccine, CAIV-T, in the fall. In
addition to the continuing progress of the pipeline, domestic sales of Synagis
grew 12 percent in the first half of 2005 to $483 million."
In connection with the dissolution in last year's second quarter of
MedImmune's relationship with Wyeth for the development and marketing of the
company's influenza vaccine technology, certain charges impacted results for
2004. In the discussion below, MedImmune has provided the overall results for
both the second quarter and six months ending June 30 with and without the
impact of these charges, as well as a reconciliation in the accompanying
schedules so that the underlying trends in the operations of the business can
be more readily identified.
Additional Results for the 2005 Second Quarter
For the second quarter of 2005, MedImmune reported a net loss of $44
million, or $0.18 per share, compared to a net loss in the 2004 second quarter
of $100 million, or $0.40 per share. Excluding the charges associated with
the termination of the Wyeth agreements, MedImmune's net loss for the 2005
second quarter remained $44 million, or $0.18 per share, compared to $29
million, or $0.12 per share, in the 2004 second quarter.
Gross margins on product sales were 67 percent in the 2005 second quarter
and 59 percent in the 2004 second quarter. Excluding the impact of FluMist,
gross margins were 71 percent in the 2005 second quarter and 76 percent in the
2004 second quarter, primarily reflecting the favorable impact of higher
international sales of Synagis during the 2004 second quarter.
Research and development (R&D) expenses increased to $79 million in the
2005 second quarter from $57 million in the 2004 second quarter, due to
increased expenses from ongoing preclinical activities and clinical trials for
product candidates, including Numax and CAIV-T.
Selling, General and Administrative (SG&A) costs in the 2005 second
quarter increased to $61 million from $58 million in the comparable 2004
period, primarily due to costs associated with expanding the pediatric sales
organization and increased co-promotion expense related to sales of Synagis in
the U.S.
Additional Results for Six-Month Period Ended June 30, 2005
For the first six months of 2005, MedImmune reported net earnings of $70
million, or $0.28 per diluted share, compared to net earnings of $11 million,
or $0.04 per diluted share in the first six months of 2004. Excluding the
charges associated with the termination of the Wyeth agreements, MedImmune's
net earnings for the 2005 first half were $71 million, or $0.28 per diluted
share, compared to $82 million, or $0.33 per share, in the 2004 first half.
Gross margins on product sales for the 2005 first half were 75 percent
compared to 66 percent in the 2004 first half. Excluding the impact of
FluMist, gross margins were 76 percent and 75 percent in the 2005 first half
and in the 2004 first half, respectively.
R&D expenses increased to $147 million in the 2005 first half from $107
million in the 2004 period, due to increased expenses from ongoing preclinical
activities and clinical trials for product candidates, including Numax and
CAIV-T. MedImmune's R&D expenditures in the first six months of 2005 were 25
percent of product sales versus 19 percent in the first half of 2004,
reflecting the continuing investment to bring new products to market as part
of the company's long-range plan.
SG&A costs in the 2005 first half increased to $218 million from $182
million in the 2004 first half due primarily to additional costs associated
with the expansion of the pediatric sales organization and increased co-
promotion expense related to sales of Synagis in the U.S.
The effective tax rate for the 2005 first half was 35 percent compared to
49 percent in the 2004 first half. The higher effective tax rate in 2004 was
due primarily to $7 million of charges associated with the termination of the
Wyeth agreements that were non-deductible for income tax purposes.
Cash and marketable securities as of June 30, 2005 were $1.8 billion, up
from $1.7 billion as of December 31, 2004, primarily due to operating cash
flow generated during the first six months of 2005. During the first six
months of 2005, MedImmune repurchased approximately 2.6 million shares of
common stock at a total cost of $67 million.
Looking Ahead in 2005
MedImmune is reconfirming its previously stated annual guidance for 2005
originally issued on February 3, 2005. The company's guidance is provided as
a convenience to investors. Guidance and objectives provided by the company
are projections and are based upon numerous assumptions, many of which
MedImmune cannot control and that may not develop as MedImmune expects. For a
discussion of the risks associated with these forward-looking statements, see
the Disclosure Notice below.
Conference Call & Webcast
MedImmune is offering a live webcast of a discussion by MedImmune
management of its earnings and other business results on Thursday, July 21,
2005 at 8:00 a.m. eastern time. The live webcast may be accessed in the
investor section of MedImmune's website, http://www.medimmune.com. A replay
of the webcast will also be available via the MedImmune website until July 28,
2005. An audio replay of the webcast will be available beginning at 10:00
a.m. eastern time on July 21, 2005 and ending at midnight July 28, 2005 by
calling 888-286-8010. The passcode for the audio replay is 83844310.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of infectious disease,
cancer and inflammatory diseases. With approximately 2,000 employees
worldwide, MedImmune is headquartered in Maryland. For more information,
visit the company's website.
DISCLOSURE NOTICE: This announcement contains historical financial
information as of and for the three-month and six-month periods ended June 30,
2005 and June 30, 2004 that is unaudited and certain audited balance sheet
information as of December 31, 2004. MedImmune assumes no obligation to
update this information based on new information or future performance except
as may be specifically required by applicable law or regulation.
This announcement also contains forward-looking statements regarding
MedImmune's future financial performance and business prospects. Those
statements involve substantial risks and uncertainties and are present in the
section captioned "Looking Ahead in 2005," as well as other sections
containing statements with words such as "anticipate," "believe," "estimate,"
"expect," "intend," "project" or other terms of similar meaning. Those
statements reflect management's current beliefs and are based on numerous
assumptions, which MedImmune cannot control and which may not develop as
MedImmune expects for reasons set forth in MedImmune's Annual Report on Form
10-K for the year ended December 31, 2004, its subsequent quarterly reports on
Form 10-Q, its current reports on Form 8-K filed for events occurring in 2005
and other public disclosures and filings with the U.S. Securities and Exchange
Commission. Consequently, actual results may differ materially from those
projected in the forward-looking statements.
MedImmune is also developing several products for potential future
marketing and the overall success of these development efforts is important
for the company's long-term prospects. There can be no assurance that such
development efforts will succeed, that such products will receive required
regulatory clearance or that, even if such regulatory clearance is received,
such products will ultimately achieve commercial success.
This press release, including the reconciliation of certain data presented
in this release to their most comparable GAAP measures, can be found on
MedImmune's website at http://www.medimmune.com in the box marked "News" or
with the archived press releases on the Investor Summary page.
MedImmune, Inc.
Consolidated Statements of Operations (Unaudited)
(in millions, except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2005 2004 2005 2004
Revenues:
Product sales $84.7 $90.7 $593.4 $573.9
Other revenue 3.8 2.9 4.9 8.7
88.5 93.6 598.3 582.6
Costs and expenses:
Cost of sales 28.0 37.3 147.8 195.5
Research and
development 78.8 57.1 147.2 106.9
Selling, general and
administrative 60.9 58.1 218.4 181.8
Other operating
expenses 2.9 2.1 5.5 3.9
Impairment of
intangible asset - 73.0 - 73.0
Acquired in-process
research and
development (IPR&D) - 24.7 - 24.7
Technology transfer
and transition
expenses 0.5 11.5 1.4 11.5
171.1 263.8 520.3 597.3
Interest income, net 15.7 14.4 30.4 28.4
(Loss) gain on
investment activities (1.2) 0.6 (0.9) 7.3
(Loss) earnings before
income taxes (68.1) (155.2) 107.5 21.0
(Benefit) provision
for income taxes (23.9) (54.9) 37.6 10.3
Net (loss) earnings $(44.2) $(100.3) $69.9 $10.7
Basic (loss) earnings
per share $(0.18) $(0.40) $0.28 $0.04
Shares used in
computing basic
(loss) earnings
per share 247.4 248.7 247.7 248.5
Diluted (loss)
earnings per
share(1) $(0.18) $(0.40) $0.28 $0.04
Shares used in
computing diluted
(loss) earnings
per share(1) 247.4 248.7 257.0 249.8
(1) In accordance with EITF No. 04-8, "The Effect of Contingently
Convertible Debt on Diluted Earnings per Share," which became effective during
the fourth quarter of 2004, the company's 1% Convertible Senior Notes, which
represent 7.3 million potential shares of common stock, are now included in
diluted earnings per share using the if-converted method, regardless of
whether the market price trigger has been met, unless the effect is anti-
dilutive. Earnings used in computing diluted earnings per share, after assumed
conversion of convertible notes, were $71.0 million for the six months ended
June 30, 2005.
MedImmune, Inc.
Selected Financial Information (Unaudited)
(in millions, except per share data)
Presented in the following table is a reconciliation of reported net
earnings (loss) under GAAP to net earnings (loss) excluding items related to
the termination of the Wyeth collaboration for FluMist during 2004. The
transition activities associated with Wyeth's exit from the collaboration are
substantially complete. MedImmune's management excludes the impact of the
charges associated with the termination of the Wyeth collaboration when
evaluating the company's ongoing performance, and provides the following
reconciliation to aid investors in their understanding of underlying
performance trends.
Three Months Ended Six Months Ended
June 30, June 30,
2005 2004 2005 2004
Item:
Net (loss) earnings,
as reported(1) $(44.2) $(100.3) $69.9 $10.7
Impairment of
intangible asset(2) - 73.0 - 73.0
Acquired in-process
research and
development(3) - 24.7 - 24.7
Technology transfer
and transition
expenses(4) 0.5 11.5 1.4 11.5
Income taxes(5) (0.2) (37.9) (0.5) (37.9)
Net (loss) earnings,
as adjusted $(43.9) $(29.0) $70.8 $82.0
Basic (loss) earnings
per share,
as reported $(0.18) $(0.40) $0.28 $0.04
Diluted (loss)
earnings per share,
as reported $(0.18) $(0.40) $0.28 $0.04
Basic (loss)
earnings per share,
as adjusted $(0.18) $(0.12) $0.29 $0.33
Diluted (loss)
earnings per share,
as adjusted(6) $(0.18) $(0.12) $0.28 $0.33
Shares used to
compute (loss)
earnings per share:
Basic, as reported 247.4 248.7 247.7 248.5
Diluted, as reported 247.4 248.7 257.0 249.8
Basic, as adjusted 247.4 248.7 247.7 248.5
Diluted, as adjusted 247.4 248.7 257.0 257.1
(1) Prepared in accordance with accounting principles generally accepted
in the United States (GAAP).
(2) Represents the addback of the noncash impairment charge associated
with the termination of our collaboration with Wyeth for the
unamortized portion of the intangible asset initially recorded upon
our acquisition of MedImmune Vaccines, Inc.
(3) Represents the addback of the portion of the amounts paid to Wyeth for
the reacquisition of the influenza vaccines franchise that was
allocated to in-process research and development (IPR&D).
(4) Represents the addback of the payments for certain transition
activities, largely comprised of amounts paid to Wyeth for the
manufacture of CAIV-T clinical trial materials, transition of clinical
trial data, and transfer of manufacturing technology knowledge.
(5) Represents the adjustment to income taxes associated with the
impairment of intangible asset, IPR&D and the technology transfer and
transition charges.
(6) Earnings used in computing adjusted diluted earnings per share, after
assumed conversion of convertible notes, were $71.9 million and $83.9
million for the six months ended June 30, 2005 and June 30, 2004,
respectively.
MedImmune, Inc.
Condensed Consolidated Balance Sheets
(in millions)
June 30, December 31,
2005 2004
(unaudited)
Assets:
Cash and marketable securities $1,771.2 $1,706.1
Trade and contract receivables, net 16.6 206.6
Inventory, net 87.5 64.1
Deferred taxes, net 147.4 177.9
Property and equipment, net 332.3 310.9
Goodwill and intangible assets, net 33.5 37.9
Other assets 57.2 60.9
$2,445.7 $2,564.4
Liabilities and shareholders' equity:
Accounts payable $17.3 $15.1
Accrued expenses 197.4 337.3
Other liabilities 44.1 30.3
Long-term debt 506.6 507.1
Shareholders' equity 1,680.3 1,674.6
$2,445.7 $2,564.4
Common shares outstanding 246.6 248.5
SOURCE MedImmune, Inc.
CONTACT:
Investors:
Peter Vozzo, +1-301-398-4358
John Filler,
+1-301-398-4086
Media:
Jamie Lacey, +1-301-398-4035
both of MedImmune,
Inc.