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This excerpt taken from the ELN 6-K filed Mar 30, 2007. Revenue
from Marketed Products
Total revenue from marketed products increased to
$249.9 million in 2006 from $204.3 million in 2005.
The 22% increase reflects higher sales of Maxipime, Azactam
and Prialt.
In June 2006, the FDA approved the re-introduction 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, in October 2006, approval was
received for the
38 Elan
Corporation, plc 2006 Annual Report
Table of Contents
Financial Review
marketing of Tysabri in
Canada. The distribution of Tysabri in both the United
States and the European Union commenced in July 2006. Global
in-market net sales of Tysabri, which we market in
collaboration with Biogen Idec, were $38.1 million in 2006,
consisting of $28.2 million in the United States and
$9.9 million in the European Union.
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
product revenues and most development and commercialisation
costs. Biogen Idec is responsible for manufacturing the product.
In the United States, we purchase Tysabri from Biogen
Idec and are responsible for distribution. In the EU market,
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.
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
2006 or 2005, 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 increased 14% to $159.9 million in
2006 from $140.3 million in 2005. The increase primarily
reflects growth in the demand for the product. The basic patent
on Maxipime expired in March 2007. Two other US patents
covering Maxipime formulations will expire in February
2008. Bristol-Myers recently received correspondence from
lawyers for Apotex stating that Apotex intends to enter the US
market with Apotex’s cefepime hydrochloride upon receiving
approval from the FDA. Bristol-Myers has requested additional
information from Apotex to determine if Apotex’s form of
cefepime hydrochloride, if approved by the FDA, infringes
Bristol-Myers patents. If Apotex or others are able to introduce
generic competitors to Maxipime our revenues from, and
gross margin for, Maxipime will be materially and
adversely affected.
Azactam revenue increased 35% to $77.9 million in
2006 from $57.7 million in 2005 primarily due to increased
demand. Azactam lost its patent exclusivity in October
2005 and its sales are expected to be adversely impacted by
generic competition. However, to date, no generic Azactam
product has been approved.
Prialt revenue increased to $12.1 million in 2006
from $6.3 million in 2005, which was primarily due to
increased demand. Prialt was launched in the US 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, 2007. (A) Revenue
from marketed products
Total revenue from marketed products increased to
$215.3 million in 2005 from $174.5 million in 2004.
The increase of 23% primarily reflects higher sales of
Maxipime and Azactam, and initial sales of
Tysabri and Prialt. Azactam lost its patent
exclusivity in October 2005, and the basic patent on Maxipime
expires in March 2007. Two US patents covering Maxipime
formulations may provide patent protection until February
2008. The expiration of these patents is expected to result in
generic competition for these products, which is expected to
adversely impact future revenues. However, to date, no generic
Azactam product has been approved.
Maxipime revenue increased from $117.5 million in
2004 to $140.3 million in 2005. The 19% increase reflects
growth in demand, a price increase of 8% taken at the end of
2004, and improved supply conditions. We experienced third party
supply shortages and disruptions with Maxipime during
2005. This led to a significant decline in inventories held by
our wholesale customers and hospitals and, consequently,
affected our ability to meet demand. The supply situation
improved beginning in the third quarter of 2005.
As reported by IMS Health Inc., Azactam prescription
demand for 2005 increased by 6% over 2004, while the
corresponding revenues increased from $50.6 million in 2004
to $57.7 million in 2005, or 14%. The difference between
prescription and revenue growth rates is due to changing
wholesaler inventory levels and price increases taken during the
period.
The FDA granted accelerated approval of Tysabri in late
November 2004 for the treatment of patients in the United States
with all forms of relapsing remitting MS. Revenue from
Tysabri amounted to $11.0 million in 2005 and
$6.4 million in 2004. The commercialization and clinical
dosing of Tysabri was voluntarily suspended in February
2005. On March 7-8, 2006, the PCNS Advisory Committee reviewed
and voted unanimously to recommend that Tysabri be
reintroduced as a treatment for relapsing forms of MS. In June
2006, the FDA approved the re-introduction 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 in October 2006, approval was
received for the
Table of Contents
marketing of Tysabri in Canada. The distribution of
Tysabri in both the United States and European Union
commenced in July 2006.
Prialt, a new treatment for severe chronic pain, was
approved by the FDA in the United States in December 2004 and
approved in Europe in February 2005. We began selling Prialt
in the US market in early 2005 and revenue from sales of
Prialt was $6.3 million in 2005 (2004: $Nil). On
March 20, 2006, we completed the sale of the
European rights to Prialt to Eisai, while retaining the
product rights in the United States.
This excerpt taken from the ELN 6-K filed Mar 31, 2006. Revenue from Marketed
Products
Total revenue from marketed products increased to
$204.3 million in 2005 from $168.1 million in 2004.
The 22% increase primarily reflects higher sales of Maxipime
and Azactam, and initial sales of Prialt,
which was launched in the United States in the first half of
2005. Azactam lost its patent exclusivity in October
2005, and the basic patent on Maxipime expires in March
2007. Two U.S. patents covering Maxipime
formulations may provide patent protection until 2008. The
expiration of these patents is expected to result in generic
competition for these products, which is expected to adversely
impact future revenues. However, to date, no generic Azactam
product has been approved.
Maxipime revenue increased from $117.5 million to
$140.3 million. The 19% increase reflects growth in demand,
a price increase of 8% taken at the end of 2004, and improved
supply conditions. We experienced third-party supply shortages
and disruptions with Maxipime during 2005. This led to a
significant decline in inventories held by our wholesale
customers and hospitals and, consequently, affected our ability
to meet demand. The supply situation improved beginning in the
third quarter of 2005.
As reported by IMS Health, Azactam prescription demand
for 2005 increased by 6% over 2004, while the corresponding
revenues increased from $50.6 million to
$57.7 million, or 14%. The difference between prescription
and revenue growth rates is due to changing wholesaler inventory
levels and price increases taken during the period.
Prialt, a new treatment for severe chronic pain, was
approved by the FDA in December 2004 and approved in Europe in
February 2005. We began selling Prialt in the
U.S. market in early 2005 and revenue from sales of
Prialt was $6.3 million in 2005 (2004: $Nil). On 20
March 2006, we completed the sale of the European rights to
Prialt to Eisai, while retaining the product rights in
the United States.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. (A) Revenue
from marketed products
Total revenue from marketed products increased to
$215.3 million in 2005 from $174.5 million in 2004.
The increase of 23% primarily reflects higher sales of
Maxipime and Azactam, and initial sales of
Tysabri and Prialt. Azactam lost
its patent exclusivity in October 2005, and the basic patent on
Maxipime expires in March 2007. Two U.S. patents
covering Maxipime formulations may provide patent
protection until 2008. The expiration of these patents is
expected to result in generic competition for these products,
which is expected to adversely impact future revenues. However,
to date, no generic Azactam product has been approved.
Maxipime revenue increased from $117.5 million to
$140.3 million. The 19% increase reflects growth in demand,
a price increase of 8% taken at the end of 2004, and improved
supply conditions. We experienced third party supply shortages
and disruptions with Maxipime during 2005. This led to a
significant decline in inventories held by our wholesale
customers and hospitals and, consequently, affected our ability
to meet demand. The supply situation improved beginning in the
third quarter of 2005.
As reported by IMS Health Inc., Azactam prescription
demand for 2005 increased by 6% over 2004, while the
corresponding revenues increased from $50.6 million to
$57.7 million, or 14%. The difference between prescription
and revenue growth rates is due to changing wholesaler inventory
levels and price increases taken during the period.
The FDA granted accelerated approval of Tysabri in late
November 2004 for the treatment of patients in the United States
with all forms of relapsing remitting MS. Revenue from
Tysabri amounted to $11.0 million in 2005 and
$6.4 million in 2004. The marketing and clinical dosing of
Tysabri was voluntarily suspended in February 2005. On
March 7-8, 2006, the PCNS Advisory Committee reviewed and voted
unanimously to recommend that Tysabri
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be reintroduced as a treatment for relapsing forms of MS. On
March 21, 2006, we and Biogen Idec were informed by the FDA
that the agency would extend its regulatory review of
Tysabri by up to 90 days in order to complete a full
review of the Tysabri risk management plan. Under the
revised timeline, we anticipate an action from the FDA about the
reintroduction of Tysabri as a treatment for relapsing
forms of MS on or before June 28, 2006.
Prialt, a new treatment for severe chronic pain, was
approved by the FDA in the United States in December 2004 and
approved in Europe in February 2005. We began selling Prialt
in the U.S. market in early 2005 and revenue from sales
of Prialt was $6.3 million in 2005 (2004: $Nil). On
March 20, 2006, we completed the sale of the
European rights to Prialt to Eisai, while retaining the
product rights in the United States.
This excerpt taken from the ELN 6-K filed Oct 27, 2005. Revenue from marketed products
Revenue from marketed products was $52.1 million in the third quarter of 2005, compared to $45.5 million recorded in the same period of 2004 due to increased sales of Maxipime and Azactam, and the sales of Prialt which was launched in 2005.
As previously reported, we have experienced third party supply shortages and disruptions with Maxipime during 2005. This has led to a significant decline in inventories that are held by our wholesale customers and hospitals and, consequently, on our ability to meet demand. As a result of the inventory shortages, Maxipime prescription volume demand for July and August of 2005 decreased by 5%, compared to the same period in 2004. Revenue for the third quarter of 2005 increased by 2% from $33.0 million in the third quarter of 2004 to $33.8 million. The supply situation improved during the third quarter and we expect to be able to meet demand and wholesaler inventory requirements during the fourth quarter of 2005. We will continue to actively manage the supply of Maxipime which is manufactured by a third party.
Azactam prescription volume demand for July and August of 2005 increased by 4%, compared to the same period of 2004, while revenue for the quarter increased from $12.5 million to $17.0 million, or 36%. Changing wholesaler inventory levels primarily explains the difference between Azactam prescription growth rate and revenue growth in the third quarter of 2005. Azactam lost patent exclusivity in October 2005 and we anticipate generic competition will have an impact on sales of Azactam from the end of the year.
Prialt, a new treatment for severe chronic pain, was approved in the U.S. in December 2004. Revenue from Prialt for the third quarter of 2005 was $1.5 million, down from $1.8 million reported in the second quarter of 2005, due to increased demand offset by reduced wholesaler inventories.
8
Elan Third Quarter 2005 Financial Results
This excerpt taken from the ELN 6-K filed Jul 28, 2005. Revenue from marketed products
Revenue from marketed products was $55.2 million in the second quarter of 2005, compared to $35.6 million recorded in the same period of 2004. The increase primarily reflects increased sales of Maxipime and Azactam.
As previously reported, we experienced third party supply shortages with Maxipime during the early part of 2005. As a result of inventory shortages, Maxipime prescription volume demand for April and May of 2005 decreased by 3%, compared to the same period in 2004. However, prescription volume demand has increased by 24% for the first five months ended May 31, 2005, compared to the same period in 2004. Revenue for the second quarter of 2005 increased from $26.5 million in the second quarter of 2004 to $39.9 million, or 51%, which resulted from a combination of supply shortages in the second quarter of 2004, increased demand for the first five months ended May 31, 2005 and re-stocking of wholesaler inventory following the supply shortages in the first quarter of 2005. We will continue to closely monitor the supply level for Maxipime.
Azactam prescription volume demand for April and May of 2005 increased by 14%, compared to the same period of 2004, while revenue for the quarter increased from $9.1 million to $14.8 million, or 63%. Changing wholesaler inventory levels primarily explains the difference between Azactam prescription growth rate and revenue growth in the second quarter of 2005. Azactam loses patent exclusivity in October 2005 and we anticipate generic competition will have an impact on sales of Azactam from the end of the year.
Prialt, a new treatment for severe chronic pain, was approved in the U.S. in December 2004 and launched in the U.S. in the first quarter of 2005. Revenue from Prialt for the second quarter of 2005 was $1.8 million, compared to $1.0 million in the first quarter of 2005.
8
Elan Second Quarter 2005 Financial Results
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