Richard Davies wrote: The UK has a good crop of technology pioneers in cloud computing - for example ElasticHosts, FlexiScale, Flexiant, OnApp - and also some strong government initiatives such as G-Cloud.
We will have to see whether this kind of technical leadership converts into swift mass-market adoption or not.
BRIDGEWATER, NJ -- (MARKET WIRE) -- 12/11/07 -- Alpharma Inc. (NYSE: ALO), a global
specialty pharmaceutical company, announced today that the company expects
2008 revenue growth in the range of 13% to 15%, and 2008 diluted earnings
per share ("EPS") in the range of $0.30 to $0.50, excluding the EPS impact
of potential milestone payments associated with the company's recent
licensing agreements. The 2008 outlook is based on the following key
assumptions:
-- Revenue growth in the company's Pharmaceuticals business in the range
of 35% to 40% driven by the expected January 2008 launch of its topical
NSAID (non-steroidal anti-inflammatory drug) product, the FLECTOR® Patch,
in addition to continued KADIAN® growth. The outlook also assumes 6% to
8% year-over-year combined revenue growth in the company's Active
Pharmaceutical Ingredients and Animal Health businesses.
-- Consolidated gross profit margins consistent with 2007 levels of
approximately 57%.
-- Research and development investment consistent with 2007 levels of
approximately 11% of revenues.
-- Selling, general and administrative expenses increasing over 2007
levels by $75 million to $85 million, primarily reflecting investments in
the Pharmaceuticals business to support the company's FLECTOR® Patch
launch. These investments include a major sales force expansion, the
engagement of a contract sales organization, and significant advertising
and promotion.
-- Potential milestone payments associated with the company's recent
licensing agreements have been excluded from the full year 2008 EPS outlook
of $0.30 to $0.50. These milestones include potential payments related to
ketoprofen in Transfersome® gel totaling up to $77 million (approximately
$1.75 EPS).
Alpharma's President and Chief Executive Officer, Dean Mitchell, commented,
"In 2007, we developed an excellent foundation for growth, and as a result,
we remain confident in our ability to achieve the strategic goals we
announced in December 2006. With a combination of internal clinical success
and licensing agreements, our Pharmaceuticals business has developed a
strong new product pipeline, and our Active Pharmaceutical Ingredients and
Animal Health businesses have continued to perform well against their
initiatives to drive future growth. In 2008, our priority will be
execution, beginning with an intense focus on our expected January launch
of the FLECTOR® Patch, followed by our NDA filing with the FDA for
approval of our abuse-deterrent extended release opioid, ALO-01."
Excluding potential milestone payments, earnings before interest, taxes,
depreciation and amortization ("EBITDA") is projected to be in a range of
approximately $78 million to $92 million, and the company is targeting
positive free cash flow for 2008. Free cash flow represents operating cash
flow less capital expenditures.
The company's 2008 outlook does not include any potential EPS dilution from
the company's convertible notes and stock warrants, based on the company's
current stock price.
Presentation of Information in this Press Release
In an effort to provide investors with additional information regarding
Alpharma's expected results as determined by U.S. Generally Accepted
Accounting Principles (GAAP), the company also has provided certain
non-GAAP information which management utilizes in its analysis of its
business and which it believes also provides useful information to
investors. This information includes earnings before interest, taxes,
depreciation, and amortization (EBITDA), and free cash flow (FCF)
representing operating cash flow, less capital expenditures.
Statements made in this release include forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. These
statements, including those relating to future financial expectations,
involve certain risks and uncertainties that could cause actual results to
differ materially from those in the forward-looking statements. The 2008
outlook assumes no material adverse events contemplated by the risk factors
described in the Company's SEC filings. Information on other important
potential risks and uncertainties not discussed herein may be found in the
Company's filings with the Securities and Exchange Commission, including
its Form 10-K for the year ended December 31, 2006, and its Form 10-Q for
the quarter ended September 30, 2007.
Conference Call Information
Alpharma management will hold a conference call to discuss the preliminary
financial outlook for 2008 at 5:00 P.M. Eastern Standard Time on December
11, 2007. The link, which includes a presentation to accompany the call,
can be accessed through the Alpharma website. The call will be open to all
interested parties and may be accessed by using the following information:
CONFERENCE CALL ACCESS
U.S. Dial In: (800) 351-4892
International Dial In: (334) 323 7224
Conference ID: ALPHARMA
In addition, for those unable to participate at the time of the call, a
rebroadcast will be available following the call from December 11, 2007 at
9:00 PM Eastern Standard Time until December 25, 2007 at midnight Eastern
Standard Time. The rebroadcast may be accessed on the Internet at
http://www.streetevents.com or by telephone using the following
information:
REBROADCAST ACCESS
U.S. Dial In: (877) 919-4059
International Dial In: (334) 323-7226
Participant Code: 21709203
About Alpharma
Alpharma Inc. (NYSE: ALO) is a global specialty pharmaceutical company with
leadership positions in products for humans and animals. Alpharma is
presently active in more than 60 countries. Alpharma has a growing branded
pharmaceutical franchise in the U.S. pain market with its KADIAN®
(morphine sulfate extended-release) Capsules, and an innovative
pharmaceutical product pipeline that consists of several novel approaches
to treat pain, including the FLECTOR® Patch (diclofenac epolamine topical
patch), which is expected to launch in January 2008. In addition, Alpharma
is among the world's leading producers of several specialty
pharmaceutical-grade bulk antibiotics and is internationally recognized as
a leading provider of pharmaceutical products for poultry and livestock.
About KADIAN® Capsules
KADIAN® (morphine sulfate extended-release) Capsules are an
extended-release formulation of morphine sulfate indicated for the
management of moderate-to-severe chronic pain, when a continuous,
around-the-clock opioid analgesic is needed for an extended period of time.
Capsules can be taken once-daily (q24h) or twice-daily (q12h), as
prescribed, to provide up to 24 hours of pain relief. Capsules will now be
available in eight strengths: 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100
mg and 200 mg. KADIAN® offers flexible dosing and administration options
that allow physicians to fine tune titration schedules and tailor treatment
for individual patient needs.
KADIAN® is a Schedule II controlled substance, with an abuse liability
similar to other opioid analgesics. The 100 mg and 200 mg capsules are for
use in opioid-tolerant patients only. KADIAN® capsules are to be
swallowed whole. The pellets in the capsules are not to be chewed,
crushed, or dissolved due to the risk of rapid release and absorption of a
potentially fatal dose of morphine. Serious adverse reactions that may be
associated with KADIAN® therapy include: respiratory depression,
respiratory arrest, circulatory depression, cardiac arrest, hypotension,
and/or shock.
About Ketoprofen in Transfersome® Gel
The licensed product candidate combines ketoprofen and IDEA AG's ("IDEA")
novel proprietary Transfersome® technology. In August 2006, IDEA
reported the positive outcome of a Phase III efficacy and safety trial of
osteoarthritis of the knee. In May 2007, IDEA submitted a regulatory filing
to the European Agency for the Evaluation of Medicinal Products (EMEA) for
approval of the product for the short and long-term treatment of
osteoarthritis, including data from four Phase II and Phase III clinical
studies in over 2000 patients.
In June 2007, IDEA received an approval for ketoprofen in Transfersome®
gel from Swiss regulators for the treatment of inflammation and pain
related to osteoarthritis. This approval was based on the first pivotal
European trial, which demonstrated that both ketoprofen in Transfersome®
gel and Celebrex® (celecoxib), improved patient's conditions comparably
and progressively over the six-week study period and are both statistically
superior to placebo. The much broader EMEA submission package also
included a long-term open-label, safety and efficacy trial with patients
treated with ketoprofen in Transfersome® gel for up to 18 months.
Alpharma believes that IDEA's EMEA filing package, including the positive
Phase III trial in Europe will be helpful for its U.S. NDA filing strategy.
IDEA plans, and will fund and conduct, two additional late stage clinical
studies: a second pivotal, placebo-controlled, Phase III US study in
osteoarthritis patients, and a multi-arm, placebo-controlled, Phase III
European study, which will also compare Ketoprofen in Transfersome® gel
to Celebrex® in a sub-study. The latter is anticipated to help evaluate
ketoprofen in Transfersome® gel as a viable alternative to oral NSAIDs,
including COX-2 products.
About the FLECTOR® Patch
The FLECTOR® Patch is a 10x14 cm adhesive patch containing 180 mg of
diclofenac epolamine applied on a non-woven felt backing and covered with a
polypropylene release liner. FLECTOR® Patch contains 1.3% epolamine salt
of diclofenac, and has been approved by the FDA for the treatment of acute
pain due to minor strains, sprains and contusions. Since its initial
approval by Swiss regulatory authorities in 1993, FLECTOR® Patch has been
approved for sale in 39 countries throughout the world. IBSA's patented
diclofenac epolamine was specifically developed to achieve a significant
release of active from the patch and promote subsequent absorption through
the skin. Application to the injured area twice a day results in a local
analgesic and anti-inflammatory effect with only minor systemic exposure to
diclofenac. FLECTOR® Patch is contraindicated for the treatment of
peri-operative pain in the setting of coronary artery bypass graft surgery.
Safety Aspects of NSAIDs
NSAIDs may cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke, which can be fatal. This risk
may increase with duration of use. Patients with cardiovascular disease or
risk factors for cardiovascular disease may be at greater risk. NSAIDs
cause an increased risk of serious gastrointestinal adverse events
including bleeding, ulceration, and perforation of the stomach or
intestines, which can be fatal. These events can occur at any time during
use and without warning symptoms. Elderly patients are at greater risk for
serious gastrointestinal events. Topically applied NSAIDS, such as
FLECTOR® Patch and ketoprofen in Transfersome® gel, are designed to
minimize systemic exposure and may provide physicians with expanded options
to treat pain.