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This excerpt taken from the ELN 6-K filed Mar 31, 2008. Product
Revenue from our Biopharmaceuticals Business
Total revenue from our Biopharmaceuticals business decreased 12%
to $222.9 million in 2007 from $252.3 million in 2006.
The decrease primarily reflects the decline in sales of
Maxipime due to generic competition, offset by higher
sales of Azactam.
In June 2006, the FDA approved the reintroduction of Tysabri
for the treatment of relapsing forms of MS. Approval for the
marketing of Tysabri in the European Union was also
received in June 2006 and has subsequently been received in a
number of other countries. The distribution of Tysabri in
both the United States and the ROW recommenced in July 2006.
Global in-market net sales of Tysabri, which we market in
collaboration with Biogen Idec, were $342.9 million in 2007
(2006: $38.1 million), consisting of $217.4 million
(2006: $28.2 million) in the United States and
$125.5 million (2006: $9.9 million) in the European
Union.
Elan Corporation, plc 2007 Annual
Report 39
Table of Contents
Tysabri was developed and is now being marketed in
collaboration with Biogen Idec. In general, subject to certain
limitations imposed by the parties, we share with Biogen Idec
most development and commercialisation costs for Tysabri.
Biogen Idec is responsible for manufacturing the product. In the
United States, we purchase Tysabri from Biogen Idec and
are responsible for distribution. Outside of the United States,
Biogen Idec is responsible for distribution.
Our collaboration with Biogen Idec for Tysabri is a
jointly-controlled operation in accordance with International
Accounting Standards (IAS) 31, “Financial Reporting of
Interests in Joint Ventures,” (IAS 31). A
jointly-controlled operation is an operation of a joint venture
that involves the use of the assets and other resources of the
venturers rather than establishing a corporation, partnership or
other entity, or a financial structure that is separate from the
venturers themselves. Each venturer uses its own property, plant
and equipment and carries its own inventories. It also incurs
its own expenses and liabilities and raises its own finance,
which represent its own obligations.
The Tysabri collaboration operating profit or loss is
calculated excluding R&D expenses (we record our share of
the total Tysabri collaboration R&D expenses within
our R&D expenses). In accordance with IAS 31, in any period
where an operating loss has been incurred by the collaboration
on sales of Tysabri, we do not recognise any Tysabri
product revenue. In any period where an operating profit has
been generated by the collaboration on sales of Tysabri,
we recognise as revenue our share of the collaboration profit
from the sale of Tysabri, plus our directly-incurred
collaboration expenses on these sales. Accordingly, we have not
recognised any product revenue from Tysabri in either
2007 or 2006, since Tysabri incurred an operating loss in
both years. Our actual operating profit or loss on Tysabri
differs from our share of the collaboration operating profit
or loss, because certain Tysabri-related expenses are not
shared through the collaboration and certain unique risks are
retained by each party.
Maxipime revenue decreased 23% to $122.5 million in
2007 from $159.9 million in 2006. The decrease in 2007 was
principally due to the introduction of generic competition. In
June 2007, the first generic formulation of cefepime
hydrochloride was approved by the FDA. Generic cefepime
hydrochloride was launched shortly thereafter, and we expect it
will continue to materially and adversely affect our revenues
from, and gross margin for, Maxipime.
Azactam revenue increased 11% to $86.3 million in
2007 from our 2006 sales level of $77.9 million. The
increase was primarily due to increased demand. Azactam
lost its patent exclusivity in October 2005, and its future
sales are expected to be negatively impacted by generic
competition, although to date no generic form of Azactam
has been approved.
Prialt revenue increased 2% to $12.3 million in 2007
from our 2006 sales level of $12.1 million. The increase
was primarily due to increased demand. Prialt was
launched in the U.S. market in the first quarter of 2005.
In March 2006, we completed the sale of the European
rights to Prialt to Eisai, while retaining the product
rights in the United States. We had not made any commercial
sales of Prialt in Europe prior to this divestment.
This excerpt taken from the ELN 20-F filed Feb 28, 2008. (A) Product
revenue from our Biopharmaceuticals business
Total product revenue from our Biopharmaceuticals business
increased 68% to $454.6 million in 2007 from
$269.8 million in 2006. The increase primarily reflects
higher sales of Tysabri and Azactam, partially
offset by the decline in sales of Maxipime due to generic
competition. In 2006, total Biopharmaceuticals product revenue
increased 23% to $269.8 million from $219.6 million in
2005. The increase reflects higher sales of Tysabri,
Maxipime, Azactam and Prialt as a result of
strong demand.
The FDA initially granted approval of Tysabri in November
2004 for the treatment of relapsing forms of MS and our
commercial distribution began shortly thereafter. The revenue
from sales of Tysabri amounted to $11.0 million in
2005 prior to the voluntary suspension of the commercialization
and clinical dosing of the product in February 2005 due to
safety concerns. In June 2006, the FDA approved the
reintroduction of Tysabri for the treatment of relapsing
forms of MS. Approval for the marketing of Tysabri in the
European Union was also received in June 2006 and has
subsequently been received in a number of other countries. The
distribution of Tysabri in both the United States and the
ROW recommenced in July 2006.
Tysabri was developed and is now being marketed in
collaboration with Biogen Idec. In general, subject to certain
limitations imposed by the parties, we share with Biogen Idec
most of the development and commercialization costs for
Tysabri. Biogen Idec is responsible for manufacturing the
product. In the United States, we purchase Tysabri from
Biogen Idec and are responsible for distribution. Consequently,
we record as revenue the net sales of Tysabri in the
U.S. market. We purchase product from Biogen Idec at a
price that includes the cost of
Table of Contents
manufacturing, plus Biogen Idec’s gross profit on
Tysabri, and this cost, together with royalties payable
to other third parties, is included in cost of sales.
Outside of the United States, Biogen Idec is responsible for
distribution and we record as revenue our share of the profit or
loss on these sales of Tysabri, plus our
directly-incurred expenses on these sales.
Global in-market net sales of Tysabri can be analyzed as
follows (in millions):
At the end of December 2007, approximately 21,100 patients
were on therapy worldwide, comprising approximately 20,400 on
commercial therapy and approximately 700 in MS clinical trials.
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