-- Soliris® (eculizumab)
Net Product Sales Increased 41% to
-- Continued Steady Growth in Core Territories: US,
-- US and EU Marketing Applications Submitted for Soliris as a Treatment for Patients with aHUS --
First Quarter 2011 Financial Highlights:
-
Q1 2011 revenues increased 41 percent to
$166.1 million , compared to$117.6 million in Q1 2010 -
Q1 2011 GAAP net income included a negative impact of
$6.9 million , or$0.07 per share, from costs related to two acquisitions that occurred during the quarter. Including this negative impact of$0.07 per share, Q1 2011 GAAP net income increased to$26.8 million , or$0.28 per share, compared to GAAP net income of$20.9 million , or$0.23 per share, in Q1 2010 -
Q1 2011 non-GAAP net income increased 63 percent to
$56.3 million , or$0.59 per share, compared to non-GAAP net income of$34.6 million , or$0.37 per share, in Q1 2010
Soliris, approved in the US (2007),
Historically, Alexion's non-GAAP operating results have been equal to GAAP operating results less both the impact of share-based compensation and taxes that are not payable in cash (non-cash taxes). With the completion of two acquisitions in the quarter, Alexion's non-GAAP operating results will now also exclude amortization of acquired intangible assets and costs associated with acquisitions. The following summary table is provided for investors' convenience:
(in thousands of US dollars, except per-share data) |
|||||||
Three months ended | |||||||
March 31 | |||||||
2011 | 2010 | ||||||
Total revenues | $ | 166,126 | $ | 117,578 | |||
GAAP net income | $ | 26,830 | $ | 20,934 | |||
Share-based compensation | 11,331 | 8,104 | |||||
Acquisition-related costs | 9,928 | - | |||||
Amortization of purchased intangibles | 69 | - | |||||
Non-cash tax expense | 8,110 | 5,516 | |||||
Non-GAAP net income | $ | 56,268 | $ | 34,554 | |||
Shares used in computing diluted earnings per share (GAAP) | 95,183 | 92,090 | |||||
Shares used in computing diluted earnings per share (non-GAAP) | 96,082 | 93,364 | |||||
GAAP earnings per share - diluted | $ | 0.28 | $ | 0.23 | |||
Non-GAAP earnings per share - diluted | $ | 0.59 | $ | 0.37 | |||
First Quarter Non-GAAP Financial Results:
The Company reported non-GAAP net income of
Alexion's non-GAAP operating expenses for Q1 2011 were
First Quarter GAAP Financial Results:
Alexion reported GAAP net income of
On a GAAP basis, operating expenses for Q1 2011 were
Balance Sheet:
As of
"In the early months of 2011, we achieved steady growth in serving
patients with PNH in our core territories, and started laying the
initial groundwork for expanding into new major countries. At the same
time, we have reached a key milestone in our aHUS program with our US
and EU regulatory submissions," said
Research and Development Programs:
aHUS Submissions
In early April, the Company announced that it has submitted marketing
applications to the
Transplant: Acute Humoral Kidney Rejection (AHR)
Eculizumab is being investigated as a treatment for patients undergoing
kidney transplant who are at elevated risk of antibody mediated
rejection, also known as acute humoral rejection (AHR). Alexion today
announced that it has recently concluded successful discussions with
regulators regarding the clinical protocols for two global,
company-sponsored controlled clinical trials evaluating eculizumab to
prevent AHR in patients undergoing kidney transplant in living- or
deceased-donor settings. The Company is preparing to initiate these
studies later this year. Alexion continues to support
investigator-initiated studies in elevated-risk kidney transplantation
in the US and
New Product Development
Alexion has established a
2011 Financial Guidance:
Earlier this month, Alexion updated its 2011 revenue guidance, from the
previously announced range of
Other items of previously announced 2011 guidance are being reiterated at this time.
Conference Call/Web Cast Information:
Alexion will host a conference call/webcast to discuss matters mentioned
in this release. The call is scheduled for today,
About Soliris:
Soliris is a first-in-class terminal complement inhibitor developed from
the laboratory through regulatory approval and commercialization by
Alexion. Soliris has been approved in the US,
About Alexion:
This press release includes certain non-GAAP financial measures that involve adjustments to GAAP figures. Alexion believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Alexion's past financial performance and its prospects for the future. The non-GAAP financial measures are included with the intent of providing both management and investors with a more complete understanding of underlying operational results and trends. In addition, these non-GAAP financial measures are among the primary indicators Alexion management uses for planning and forecasting purposes and measuring the Company's performance. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP figures. A reconciliation of the GAAP to non-GAAP figures is included in this press release.
[ALXN-E]
This news release contains forward-looking statements, including
statements related to guidance regarding anticipated financial results
for 2011, assessment of the Company's financial position and
commercialization efforts, medical benefits and commercial potential for
Soliris for PNH and aHUS and other potential indications, expansion of
clinical and commercial operations to additional countries, potential of
Alexion's complement-inhibition technology and other technologies; plans
for clinical programs for each of our product candidates; plans for
recently acquired companies and programs; progress in developing
commercial infrastructure, and interest and acceptance regarding Soliris
in the patient, physician and payor communities. Forward-looking
statements are subject to factors that may cause Alexion's results and
plans to differ from those expected, including for example, decisions of
regulatory authorities regarding marketing approval or material
limitations on the marketing of Soliris for PNH and aHUS and other
potential indications, delays in arranging satisfactory manufacturing
capabilities and establishing commercial infrastructure, the possibility
that results of clinical trials are not predictive of safety and
efficacy results of Soliris in broader patient populations in the
disease studied or other diseases, the risk that recent acquisitions
will not result in short-term or long-term benefits, risks related to
the integration of the operations of Taligen into Alexion, the
possibility that initial results of commercialization are not predictive
of future rates of adoption of Soliris in PNH, aHUS or other diseases,
the risk that third parties will not agree to license any necessary
intellectual property to Alexion on reasonable terms or at all, the risk
that third party payors (including governmental agencies) will not
reimburse for the use of Soliris at acceptable rates or at all, the risk
that estimates regarding the number of patients with PNH, aHUS or other
disorders is inaccurate, and a variety of other risks set forth from
time to time in Alexion's filings with the
ALEXION PHARMACEUTICALS, INC. | |||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
(in thousands, except per share amounts) | |||||||||
(unaudited) | |||||||||
Three months ended | |||||||||
March 31 | |||||||||
2011 | 2010 | ||||||||
Net product sales | $ | 166,126 | $ | 117,578 | |||||
Cost of sales (1) | 19,228 | 13,999 | |||||||
Operating expenses: | |||||||||
Research and development (1) | 30,810 | 22,374 | |||||||
Selling, general and administrative (1) | 65,858 | 50,635 | |||||||
Acquisition-related costs (2) | 9,928 | - | |||||||
Amortization of purchased intangibles | 69 | - | |||||||
Total operating expenses | 106,665 | 73,009 | |||||||
Operating income | 40,233 | 30,570 | |||||||
Other income (expense) | 593 | (497 | ) | ||||||
Income before income taxes | 40,826 | 30,073 | |||||||
Income tax provision | 13,996 | 9,139 | |||||||
Net income | $ | 26,830 | $ | 20,934 | |||||
Earnings per common share | |||||||||
Basic | $ | 0.30 | $ | 0.24 | |||||
Diluted | $ | 0.28 | $ | 0.23 | |||||
Shares used in computing earnings per common share | |||||||||
Basic | 90,862 | 88,506 | |||||||
Diluted | 95,183 | 92,090 | |||||||
(1) |
The following table summarizes the share-based compensation expense |
||||||||
Three months ended | |||||||||
March 31 | |||||||||
2011 | 2010 | ||||||||
Share-based compensation expense: | |||||||||
Cost of sales | $ | 545 | $ | 315 | |||||
Research and development | 2,733 | 2,085 | |||||||
Selling, general and administrative | 8,053 | 5,704 | |||||||
$ | 11,331 | $ |
8,104 |
||||||
(2) |
Acquisition-related costs during the quarter ended March 31, 2011
include |
||||||||
ALEXION PHARMACEUTICALS, INC. | ||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(in thousands) | ||||||
(unaudited) | ||||||
March 31, | December 31, | |||||
2011 | 2010 | |||||
Cash, cash equivalents and marketable securities | $ | 348,784 | $ | 361,605 | ||
Trade accounts receivable, net | 200,729 | 168,732 | ||||
Inventories, net | 74,398 | 62,165 | ||||
Deferred tax assets, current | 20,470 | 19,643 | ||||
Other current assets | 24,915 | 34,411 | ||||
Property, plant and equipment, net | 160,625 | 162,240 | ||||
Deferred tax assets, noncurrent | 144,844 | 154,569 | ||||
Intangibles assets, net | 95,249 | 24,146 | ||||
Goodwill | 79,114 | 19,954 | ||||
Other noncurrent assets | 5,401 | 4,572 | ||||
Total assets | $ | 1,154,529 | $ | 1,012,037 | ||
Accounts payable and accrued expenses | $ | 125,648 | $ | 123,056 | ||
Other current liabilities | 27,816 | 15,459 | ||||
Revolving credit facility | 60,000 | - | ||||
Long term debt | 3,718 | 3,718 | ||||
Contingent consideration | 15,617 | - | ||||
Other noncurrent liabilities | 20,365 | 10,068 | ||||
Total liabilities | 253,164 | 152,301 | ||||
Total stockholders' equity | 901,365 | 859,736 | ||||
Total liabilities and stockholders' equity | $ | 1,154,529 | $ | 1,012,037 |
Sr.
Director, Corporate Communications
or
or
Source:
News Provided by Acquire Media