Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN), Cheshire, Conn., has
announced financial results for the quarter ended June 30, 2007.
Second Quarter Highlights:
* During April 2007, Alexion initiated commercial sales of
SolirisTM (eculizumab) in the United States for the treatment of
paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening
blood disorder.
* Soliris product sales in the United States and Europe totaled
$9.8 million.
* All Soliris patients from the Phase III extension clinical trial
in the United States and early access program in the United States have
been converted to commercial product.
* New patients who did not participate in Soliris clinical trials
or the early access program currently represent the majority of
commercial Soliris patients in the United States.
* The European Commission granted marketing approval for Soliris
for all patients with PNH.
* Alexion acquired exclusive world-wide rights to FLAER, a highly
sensitive diagnostic test for PNH.
Second Quarter Financial Results:
For the second quarter, Alexion Pharmaceuticals, Inc. has reported
revenues of $9.8 million compared to revenues of $0.3 million for the
same period last year. All reported revenues from this quarter are
Soliris product sales.
Cost of product sales for the three months ended June 30, 2007 was
$1.1 million, resulting in a gross profit of $8.7 million. Product sold
during the three months ended June 30, 2007 was previously expensed,
prior to submission of the Biologic License Application (BLA), and
therefore was not included in the cost of product revenues during this
period. Cost of product sales includes estimated royalty costs related
to the sale of Soliris and other manufacturing costs.
Operating expenses for the second quarter were $38.0 million,
compared to $34.9 million for the same period last year. Research and
development expenses for the quarter ended June 30, 2007 were $15.2
million compared to $23.5 million for the same period last year. The
decrease in second quarter 2007 research and development expenses
compared to the same period in 2006 is related to the termination of the
pexelizumab programs in late 2006, as well as the transition of Soliris
from research and development stages to a commercial product. Selling,
general and administrative expenses were $22.8 million for the three
months ended June 30, 2007, compared to $11.4 million for the same
period last year. The increase in selling, general and administrative
expenses for the second quarter of 2007 is primarily related to the
development of commercial operations and other infrastructure to support
the launch of Soliris in the United States and Europe.
Operating expenses for the three months reported include $5.3
million of share-based compensation expense compared to $3.7 million in
the same period last year.
The company posted investment income for the three months ended
June 30, 2007 of $2.2 million compared to $2.0 million for the same
period last year, reflecting higher market interest rates. For the three
months ended June 30, 2007, interest expense was $0.5 million compared
to $0.7 million for the same period last year.
The company incurred a net loss for the quarter ended June 30, 2007
of $27.2 million, or $0.75 basic and diluted net loss per common share,
compared to a net loss of $33.2 million, or $1.06 basic and diluted net
loss per common share, for the same period during 2006. Excluding
share-based compensation, the company incurred a non-GAAP net loss for
the quarter ended June 30, 2007 of $21.8 million, or $0.61 per common
share, versus a non-GAAP net loss of $29.5 million, or $0.94 per common
share, for the same period during 2006.
In connection with the purchase and upgrade of its manufacturing
facility in Rhode Island, the company capitalized renovation and upgrade
costs of $16.0 million during the quarter ended June 30, 2007.
Cumulative capitalized expenses related to the facility totaled $58.8
million as of June 30, 2007. Construction of the Rhode Island facility
is now substantially complete and engineering runs are anticipated in
2007. Completion of engineering runs will enable the company to begin
validation production for regulatory approval of the facility.
As of June 30, 2007, the company had $152.4 million in cash, cash
equivalents, and marketable securities compared to $250.1 million at
December 31, 2006. The decrease is attributable to the ongoing
completion of the manufacturing facility, as well as the continued
development of commercial operations. As of June 30, 2007, $9.5 million
of cash was restricted and designated for completion of the
manufacturing facility in Rhode Island.
In addition to the $152.4 million in cash, cash equivalents, and
marketable securities reported as of June 30, 2007, in July 2007 the
company amended its existing Rhode Island manufacturing facility
mortgage loan agreement to borrow an additional $18 million, resulting
in an aggregate principal balance of $44 million.
Non-GAAP Financial Information - Non-GAAP financial information is
utilized by the Company's management to provide a useful measure of
comparative operating performance of the company. Non-GAAP financial
information excludes the effect of share-based compensation expense.
Reconciliation between non-GAAP financial measures and GAAP financial
measures is included in the table accompanying this press release
following the unaudited Selected Financial Data.
Soliris Commercial Update United States During the quarter, all
patients from the Phase III extension clinical trial in the U.S. and
early access program in the U.S. have been converted to commercial
Soliris. Patients identified prior to launch but who did not participate
in clinical trials, together with patients identified after launch,
currently represent the majority of commercial patients in the United
States.
"Initial results of the U.S. launch of Soliris have exceeded
our expectations," said Dr. Leonard Bell, CEO of Alexion. "Our
field force and OneSource team are working successfully with physicians,
patients and payers to communicate the significant clinical benefits of
Soliris and to secure access to therapy. So far, we are making
significant progress toward achieving our top priority of making Soliris
available to every PNH patient who can benefit from it."
The company is moving forward with several commercial and clinical
development initiatives:
* Alexion recently acquired exclusive world-wide rights to FLAER, a
highly sensitive diagnostic test for PNH. The FLAER test has been shown
to permit a more accurate determination of the size of the PNH clone as
compared to standard flow cytometry. Increased use of the FLAER test has
the potential to improve both the rate and accuracy of diagnosis for
PNH.
* During the quarter, the company announced the expansion of the
EXPLORE study, which is examining the frequency and clinical
characteristics of PNH in patients with aplastic anemia, myelodysplastic
syndrome and other bone marrow disorders. The company is now planning to
enroll up to 10,000 bone marrow disorder patients in the study.
Soliris Commercial Update International
On June 22, 2007, Alexion announced that the European Commission
granted marketing approval for Soliris for all patients with PNH. Since
that time, the company has been working on completing the reimbursement
processes, which vary by country. The company continues to sell Soliris
on a named-patient basis in Europe. Alexion expects to make Soliris
commercially available during the fourth quarter of this year in Germany
and the United Kingdom, followed by other major European countries in
2008.
"The science, clinical data and approved product label in
Europe all support broad access to Soliris for the treatment of PNH. We
are working with officials in major markets to secure reimbursement, and
we expect initial commercial launch during the fourth quarter of this
year," said David Keiser, president and COO of Alexion. "We
continue to attract exceptional talent into the organization as we scale
up our commercial operations on a country by country basis. Like the
U.S., our goal in Europe is that every patient who can benefit from
Soliris, will have access to Soliris."
In June 2007, Alexion was informed by the Australian regulatory
authorities that it had granted priority review status for the recently
submitted Soliris New Drug Application.
Financial Guidance
For 2007, earlier guidance of GAAP-based total operating expenses
in the range of $160 to $180 million remains unchanged. Excluding the
expense of employee stock options and other share-based compensation
expense, the projected non-GAAP total operating expenses for 2007 in the
range of $140 to $160 million remains unchanged.
The financial results and the amount of net loss that is likely in
2007 will vary depending upon many factors, including the level of
increases in Soliris product sales, acceptance of Soliris in the medical
community, pricing of Soliris in Europe and reimbursements from
third-party insurers, government agencies and other third party payors.
About Alexion
Alexion Pharmaceuticals, Inc. is a biotechnology company working to
develop and deliver life-changing drug therapies for patients with
serious and life-threatening medical conditions. The company is engaged
in the discovery, development and commercialization of therapeutic
products aimed at treating patients with a wide array of severe disease
states, including hematologic diseases, cancer, and autoimmune
disorders. In March 2007, the FDA granted marketing approval for the
company's first product, Soliris for all patients with PNH and the
company began commercial sale of Soliris in the U.S. during April 2007.
In June 2007, the European Commission granted marketing approval for
Soliris in the European Union for all patients with PNH. The company is
evaluating other potential indications for Soliris as well as other
formulations of eculizumab for additional clinical indications, and is
actively pursuing development of other antibody product candidates in
early stages of development.
For more information, visit http://www.alexionpharm.com or call
908/369-7168.
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