-- Soliris® (eculizumab)
Net Product Sales Increased 48% to
-- Guidance Revised Upward for Revenues and Non-GAAP EPS --
-- Soliris for aHUS Granted Priority Review in the US —
-- STEC-HUS Program Added to Development Pipeline --
Second Quarter 2011 Financial Highlights:
-
Q2 2011 revenues increased 48 percent to
$185.7 million , compared to$125.8 million in Q2 2010 -
Q2 2011 GAAP net income increased 60 percent to
$34.7 million , or$0.18 per share, compared to GAAP net income of$21.8 million , or$0.12 per share, in Q2 2010 -
Q2 2011 non-GAAP net income increased 54 percent to
$56.8 million , or$0.29 per share, compared to non-GAAP net income of$36.9 million , or$0.20 per share, in Q2 2010
Soliris, approved in the US (2007),
Alexion's non-GAAP operating results are equal to GAAP operating results less the impact of share-based compensation, taxes that are not payable in cash (non-cash taxes), amortization of acquired intangible assets, and costs associated with acquisitions. A reconciliation of GAAP and non-GAAP results is summarized below:
|
(in thousands of US dollars, except per-share data) |
||||||||||||||
| Three months ended | Six months ended | |||||||||||||
| June 30 | June 30 | |||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||
| Total revenues | $ | 185,699 | $ | 125,834 | $ | 351,825 | $ | 243,412 | ||||||
| GAAP net income | $ | 34,745 | $ | 21,773 | $ | 61,575 | $ | 42,707 | ||||||
| Share-based compensation | 11,834 | 8,250 | 23,165 | 16,354 | ||||||||||
| Acquisition-related costs | 1,000 | - | 10,928 | - | ||||||||||
| Amortization of purchased intangibles | 104 | - | 174 | - | ||||||||||
| Non-cash tax expense | 9,095 | 6,923 | 17,205 | 12,439 | ||||||||||
| Non-GAAP net income | $ | 56,778 | $ | 36,946 | $ | 113,047 | $ | 71,500 | ||||||
| Shares used in computing diluted earnings per share (GAAP) |
191,187 |
185,150 | 190,790 | 184,680 | ||||||||||
| Shares used in computing diluted earnings per share (non-GAAP) |
193,048 |
187,704 | 192,605 | 187,222 | ||||||||||
| GAAP earnings per share - diluted | $ | 0.18 | $ | 0.12 | $ | 0.32 | $ | 0.23 | ||||||
| Non-GAAP earnings per share - diluted | $ | 0.29 | $ | 0.20 | $ | 0.59 | $ | 0.38 | ||||||
The Company effected a 2-for-1 stock split in the form of a 100 percent
stock dividend on
Second Quarter Non-GAAP Financial Results:
The Company reported non-GAAP net income of
Alexion's non-GAAP operating expenses for Q2 2011 were
Second Quarter GAAP Financial Results:
Alexion reported GAAP net income of
On a GAAP basis, operating expenses for Q2 2011 were
Balance Sheet:
As of
"In the second quarter, we continued to serve a growing number of new
patients with PNH in our core territories of the US,
Research and Development Programs:
aHUS Regulatory Submissions
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). The
STEC-HUS
Following authorization by the Paul-Ehrlich-Institut (PEI), Germany's
healthcare regulatory body for biologics, and an access program for
patients initiated in May, Alexion initiated an open-label clinical
trial to investigate eculizumab as a treatment for patients with
2011 Financial Guidance:
Alexion's 2011 revenue guidance has been revised upward, from the
previously announced range of
On a non-GAAP basis, guidance for 2011 R&D expenses has been increased
from the previous range of
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 amounts. Alexion believes that these non-GAAP financial measures, when considered together with the GAAP amounts, 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 for measuring the Company's performance. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP amounts. A reconciliation of the GAAP to non-GAAP amounts 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, medical and
commercial potential of Alexion's complement-inhibition technology and
other technologies; plans for clinical programs for each of our product
candidates; 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 Therapeutics 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 | Six months ended | |||||||||||||||
| June 30 | June 30 | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Net product sales | $ | 185,699 | $ | 125,834 | $ | 351,825 | $ | 243,412 | ||||||||
| Cost of sales (1) | 21,745 | 13,721 | 40,973 | 27,720 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | 35,646 | 23,690 | 66,456 | 46,064 | ||||||||||||
| Selling, general and administrative (1) | 78,180 | 56,098 | 144,037 | 106,733 | ||||||||||||
| Acquisition-related costs (2) | 1,000 | - | 10,928 | - | ||||||||||||
| Amortization of purchased intangibles | 104 | - | 174 | - | ||||||||||||
| Total operating expenses | 114,930 | 79,788 | 221,595 | 152,797 | ||||||||||||
| Operating income | 49,024 | 32,325 | 89,257 | 62,895 | ||||||||||||
| Other income (expense) | 63 | (242 | ) | 656 | (739 | ) | ||||||||||
| Income before income taxes | 49,087 | 32,083 | 89,913 | 62,156 | ||||||||||||
| Income tax provision (3) | 14,342 | 10,310 | 28,338 | 19,449 | ||||||||||||
| Net income | $ | 34,745 | $ | 21,773 | $ | 61,575 | $ | 42,707 | ||||||||
| Earnings per common share | ||||||||||||||||
| Basic | $ | 0.19 | $ | 0.12 | $ | 0.34 | $ | 0.24 | ||||||||
| Diluted | $ | 0.18 | $ | 0.12 | $ | 0.32 | $ | 0.23 | ||||||||
| Shares used in computing earnings per common share | ||||||||||||||||
| Basic | 182,962 | 178,004 | 182,347 | 177,510 | ||||||||||||
| Diluted |
191,187 |
185,150 | 190,790 | 184,680 | ||||||||||||
| (1) |
The following table summarizes the share-based compensation expense included in the respective captions of the condensed consolidated statements of operations: |
|||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30 | June 30 | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Share-based compensation expense: | ||||||||||||||||
| Cost of sales | $ | 572 | $ | 250 | $ | 1,117 | $ | 565 | ||||||||
| Research and development | 2,245 | 2,025 | 4,978 | 4,110 | ||||||||||||
| Selling, general and administrative | 9,017 | 5,975 | 17,070 | 11,679 | ||||||||||||
| $ | 11,834 | $ | 8,250 | $ | 23,165 | $ | 16,354 | |||||||||
| (2) |
The following table summarizes the acquisition-related costs included in the condensed consolidated statements of operations: |
|||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30 | June 30 | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Transaction and separation costs | $ | 255 | $ | - | $ | 10,047 | $ | - | ||||||||
| Adjustments to fair value of contingent consideration | 745 | - | 881 | - | ||||||||||||
| $ | 1,000 | $ | - | $ | 10,928 | $ | - | |||||||||
| (3) |
The following table summarizes the non-cash tax expense representing the reduction in cash taxes attributable to the utilization of US net operating losses (NOL's): |
|||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30 | June 30 | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Non-cash taxes | $ | 9,095 | $ | 6,923 | $ | 17,205 | $ | 12,439 | ||||||||
| ALEXION PHARMACEUTICALS, INC. | ||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| (in thousands) | ||||||
| (unaudited) | ||||||
| June 30, | December 31, | |||||
| 2011 | 2010 | |||||
| Cash, cash equivalents and marketable securities | $ | 368,009 | $ | 361,605 | ||
| Trade accounts receivable, net | 212,720 | 168,732 | ||||
| Inventories, net | 75,222 | 62,165 | ||||
| Deferred tax assets, current | 20,863 | 19,643 | ||||
| Other current assets | 23,581 | 34,411 | ||||
| Property, plant and equipment, net | 163,763 | 162,240 | ||||
| Deferred tax assets, noncurrent | 135,518 | 154,569 | ||||
| Intangibles assets, net | 94,019 | 24,146 | ||||
| Goodwill | 80,033 | 19,954 | ||||
| Other noncurrent assets | 5,847 | 4,572 | ||||
| Total assets | $ | 1,179,575 | $ | 1,012,037 | ||
| Accounts payable and accrued expenses | $ | 154,683 | $ | 123,056 | ||
| Other current liabilities | 33,086 | 15,459 | ||||
| Long term debt | - | 3,718 | ||||
| Contingent consideration | 17,601 | - | ||||
| Other noncurrent liabilities | 20,703 | 10,068 | ||||
| Total liabilities | 226,073 | 152,301 | ||||
| Total stockholders' equity | 953,502 | 859,736 | ||||
| Total liabilities and stockholders' equity | $ | 1,179,575 | $ | 1,012,037 | ||
Sr.
Director, Corporate Communications
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