- Sales of Synagis(R) increased 12 percent to $472 million
- FluMist supplements approved by FDA to reduce normal allantoic fluid (NAF) and eliminate FreezeBox storage requirements
- Ex-U.S. distribution agreement with Abbott amended to include Numax(TM)
- Data from Phase 1 and Phase 1/2 clinical development trials for Numax presented in March at 7th International Symposium on Respiratory Viral Infections
- Amended licensing agreement signed with GlaxoSmithKline (GSK) for vaccines to prevent cervical cancer in Phase 3 development at GSK and Merck
- Dosing initiated in Phase 1 study for nasally administered RSV/PIV-3 vaccine
GAITHERSBURG, Md., April 21, 2005 /PRNewswire-FirstCall via COMTEX/ -- MedImmune, Inc.
(Nasdaq: MEDI) today announced that total revenues for the 2005 first quarter
increased to $510 million from $489 million in the 2004 first quarter.
Driving the growth in revenues was a 12-percent increase in worldwide sales of
Synagis (palivizumab) to $472 million in the 2005 first quarter compared to
$422 million in the 2004 first quarter. Sales of Ethyol(R) (amifostine) and
CytoGam(R) (cytomegalovirus immune globulin intravenous (human)) were $23
million and $12 million, respectively, in the first quarter 2005 versus $24
million and $10 million, respectively, in the 2004 first quarter. In the 2005
first quarter, sales of FluMist (Influenza Virus Vaccine Live, Intranasal)
were $3 million, as sales for the influenza vaccine continued into 2005. In
the 2004 first quarter, product sales of FluMist were $26 million, reflecting
revenue associated with vaccine that was shipped to MedImmune's former
partner, Wyeth, in 2003. While the product had been shipped in 2003, the
associated revenue was not recognized until the first quarter of 2004 when
returns and discounts could be reliably estimated.
"Synagis continued to set new worldwide sales records in the first quarter
of 2005, and achieved a 13-percent increase in domestic sales," stated David
M. Mott, president and chief executive officer. "In addition, we continued to
advance our pipeline by initiating patient enrollment in the Southern
Hemisphere for our pivotal Phase 3 study for Numax; completing patient
enrollment in our Phase 2 prostate cancer study with Vitaxin(R); and starting
a Phase 1 study with our intranasal RSV/PIV-3 vaccine. Through these
developments and other advances, we continue to make steady progress towards
our long-term goal of achieving approximately $2 billion in revenues in 2009."
MedImmune's net earnings for the 2005 first quarter also increased to $114
million, or $0.45 per diluted share, from $111 million, or $0.43 per diluted
share in the 2004 first quarter.
Gross margins on product sales were 76 percent in the 2005 first quarter
and 67 percent in the 2004 quarter. Gross margins for FluMist did not
materially impact overall margins for the 2005 first quarter, but reduced 2004
first quarter gross margins by eight percentage points.
Research and development expenses increased to $69 million in the 2005
first quarter from $50 million in the 2004 first quarter largely due to
increased expenses from ongoing preclinical activities and clinical trials for
product candidates, including Numax and CAIV-T.
Selling, general and administrative costs in the 2005 first quarter
increased to $158 million from $124 million in the 2004 first quarter, due
primarily to increased co-promotion expense related to sales of Synagis and
the impact of the ongoing costs associated with last year's expansion of the
pediatric commercial organization.
The effective tax rate for the 2005 first quarter was 35 percent compared
to 37 percent in the 2004 first quarter, reflecting an increase in the amount
of credits available for R&D activities.
Cash and marketable securities at March 31, 2005 were $1.9 billion, up
from $1.7 billion at December 31, 2004, primarily due to operating cash flow
generated in the first quarter. During the 2005 first quarter, MedImmune
repurchased about 700,000 shares of its common stock at a total cost of
approximately $17 million.
Looking Ahead in 2005
MedImmune is reconfirming its previously stated annual guidance for 2005
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, April 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 April
28, 2005. An audio replay of the webcast will be available beginning at 10:00
a.m. eastern time on April 21, 2005 and ending at midnight April 28, 2005 by
calling (888) 286-8010. The passcode for the audio replay is 26521150.
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 periods ended March 31, 2005 and
March 31, 2004 that is unaudited (except for the balance sheet information as
of December 31, 2004), and 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 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 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.
Consolidated Statements of Operations (unaudited)
(in millions, except per share data)
Three Months Ended
Product sales $508.7 $483.2
Other revenue 1.1 5.8
Costs and expenses:
Cost of sales 119.8 158.2
Research and development (1) 69.3 49.8
Selling, general and administrative 157.5 123.7
Other operating expenses 2.6 1.8
Interest income, net 14.7 14.0
Gain on investment activities 0.3 6.7
Earnings before income taxes 175.6 176.2
Provision for income taxes 61.5 65.2
Net earnings $114.1 $111.0
Basic earnings per share $0.46 $0.45
Shares used in computing basic earnings
per share 248.1 248.2
Diluted earnings per share (2) $0.45 $0.43
Shares used in computing diluted
earnings per share (2) 257.2 258.2
(1) Research and development expenses in the 2005 quarter include $0.9
million in transition expenses related to the termination of the Wyeth
agreements for the influenza vaccine franchise.
(2) In accordance with EITF No. 04-8, "The Effect of Contingently
Convertible Debt on Diluted Earnings per Share," which became effective during
2004, the Company's 1% Convertible Senior Notes 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. In
accordance with the EITF, prior period diluted earnings per share have been
restated for comparative purposes. Earnings used in computing diluted earnings
per share, after assumed conversion of convertible notes, was $114.7 million
and $112.2 million for the three months ended March 31, 2005 and 2004,
Condensed Consolidated Balance Sheets
March 31, December 31,
Cash and marketable securities $1,883.7 $1,706.1
Trade and contract receivables, net 219.2 206.6
Inventory, net 72.5 64.1
Deferred taxes, net 128.3 177.9
Property and equipment, net 318.8 310.9
Goodwill and intangible assets, net 35.7 37.9
Other assets 59.6 60.9
Liabilities and shareholders' equity:
Accounts payable $13.5 $15.1
Accrued expenses 408.3 337.3
Other liabilities 32.5 30.3
Long term debt 506.9 507.1
Shareholders' equity 1,756.6 1,674.6
Common shares outstanding 248.2 248.5
SOURCE MedImmune, Inc.
all of MedImmune, Inc.