- Soliris® Net Product Sales Increased 40 Percent to
- Continued Strong Uptake of Soliris by New Patients in Core
Territories: U.S.,
- aHUS and Transplant Programs Advance —
- Taligen and Orphatec Acquisitions Expand Rare Disease Pipeline -
Fourth Quarter 2010 Financial Highlights:
-
Q4 2010 net product sales increased 41 percent to
$156.0 million , compared to$110.6 million in Q4 2009. -
Q4 2010 GAAP net income was
$26.5 million , or$0.28 per share, compared to Q4 2009 GAAP net income of$237.1 million , or$2.59 per share, which included a non-recurring tax benefit of$215.5 million , or$2.36 per share. -
Q4 2010 non-GAAP net income increased 71 percent to
$48.6 million , or$0.51 per share, compared to Q4 2009 non-GAAP net income of$28.5 million , or$0.31 per share.
Full-Year 2010 Financial Highlights:
-
2010 net product sales increased 40 percent to
$541.0 million , compared to$386.8 million in 2009. -
2010 GAAP net income was
$97.0 million , or$1.04 per share, compared to 2009 GAAP net income of$295.2 million , or$3.26 per share, which included a non-recurring tax benefit of$215.5 million , or$2.38 per share. -
2010 non-GAAP net income increased 54 percent to
$167.3 million , or$1.78 per share, compared to 2009 non-GAAP net income of$108.4 million , or$1.18 per share.
Soliris, approved in the U.S. (2007),
Historically, Alexion's non-GAAP operating results have been equal to GAAP operating results less the impact of share-based compensation and taxes that are not payable in cash (non-cash taxes). Additionally, acquisition-related expenses are excluded from non-GAAP results. The following summary table is provided for investors' convenience.
|
(in thousands, except per-share data) |
|||||||||||||||
| Three Months Ended | Twelve Months Ended | ||||||||||||||
| December 31, | December 31, | ||||||||||||||
| 2010 | 2009 | 2010 | 2009 | ||||||||||||
| Net product sales | $ | 155,975 | $ | 110,649 | $ | 540,957 | $ | 386,800 | |||||||
| GAAP net income | $ | 26,450 | $ | 237,127 | $ | 97,030 | $ | 295,166 | |||||||
| Share-based compensation | 7,605 | 6,878 | 32,338 | 28,731 | |||||||||||
| Acquisition expense | 722 | - | 722 | - | |||||||||||
| Non-cash taxes | 13,860 | (215,516 | ) | 37,229 | (215,516 | ) | |||||||||
| Non-GAAP net income | $ | 48,637 | $ | 28,489 | $ | 167,319 | $ | 108,381 | |||||||
| Shares used in computing diluted earnings per share (GAAP) | 94,293 | 91,449 | 93,037 | 90,582 | |||||||||||
| Shares used in computing diluted earnings per share (non-GAAP) | 95,208 | 92,532 | 94,247 | 91,780 | |||||||||||
| GAAP earnings per share - diluted | $ | 0.28 | $ | 2.59 | $ | 1.04 | $ | 3.26 | |||||||
| Non-GAAP earnings per share - diluted | $ | 0.51 | $ | 0.31 | $ | 1.78 | $ | 1.18 | |||||||
Fourth Quarter Non-GAAP Financial Results:
The Company reported non-GAAP net income of
Alexion's non-GAAP operating expenses for Q4 2010 were
Fourth Quarter GAAP Financial Results:
Alexion reported GAAP net income of
On a GAAP basis, operating expenses for Q4 2010 were
Full Year 2010 Non-GAAP Financial Results:
The Company reported non-GAAP net income of
Alexion's non-GAAP operating expenses for the full year 2010 were
Full Year 2010 GAAP Financial Results:
Alexion reported GAAP net income of
Alexion's GAAP operating expenses for the full year 2010 were
Balance Sheet:
As of
During the fourth quarter of 2010, Alexion made significant progress on advancing the development of eculizumab as a treatment for patients suffering from additional rare and severe complement-mediated disorders beyond PNH, with a focus on its two lead nephrology programs in aHUS and transplant.
atypical Hemolytic Uremic Syndrome (aHUS)
In
The Company has completed dosing in these two Phase 2 clinical studies of eculizumab as an investigational treatment for patients with aHUS. A separate clinical study in pediatric patients with aHUS, as well as an additional study in adult patients, is ongoing.
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, or AHR. The Company is
supporting investigator-initiated studies in elevated-risk kidney
transplantation in the U.S. and
Acquisition of Orphatec Assets:
This morning, Alexion announced that it has purchased patents and assets
from
Deficiency of the cofactor leads to accumulation of neurotoxic sulfite, resulting in uncontrollable seizures, severe and rapid neurological damage and death. There are currently no treatment options for patients with MoCD Type A.
The investigational therapy is designed to replace the deficient cPMP,
which enables MoCD production so that the infant's body can eliminate
the toxic sulfite. Scientific discoveries underlying this highly
innovative therapy were pioneered in
The Orphatec assets were purchased with an upfront cash payment of
approximately
Taligen Acquisition:
On
"In 2010, we exceeded our clinical and commercial objectives. We served
significantly greater numbers of patients with PNH in our core
territories of the U.S.,
2011 Financial Guidance:
In 2011, worldwide net product sales are expected to be within a 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 U.S.,
About Alexion:
[ALXN-E]
This news release contains forward-looking statements, including
statements related to guidance regarding anticipated financial results
for 2011, projected tax rates, assessment of the Company's financial
position and commercialization efforts, potential benefits and
commercial potential for Soliris, potential of Alexion's
complement-inhibition technology for treatment of diseases other than
PNH; plans for clinical programs for Soliris in non-PNH indications and
for samalizumab; plans for recently acquired companies and programs;
progress in developing commercial infrastructure and interest about
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, delays in arranging
satisfactory manufacturing capabilities and establishing commercial
infrastructure, delays in developing or adverse changes in commercial
relationships, the possibility that results of clinical trials are not
predictive of safety and efficacy results of Soliris in broader patient
populations, 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, 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 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 | Twelve Months Ended | ||||||||||||||||
| December 31, | December 31, | ||||||||||||||||
| 2010 | 2009 | 2010 | 2009 | ||||||||||||||
| Net product sales | $ | 155,975 | $ | 110,649 | $ | 540,957 | $ | 386,800 | |||||||||
| Cost of sales (1) | 20,222 | 12,892 | 64,437 | 45,059 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development (1) | 27,177 | 23,215 | 98,394 | 81,915 | |||||||||||||
| Selling, general and administrative (1) | 63,547 | 51,887 | 227,488 | 172,767 | |||||||||||||
| Total operating expenses | 90,724 | 75,102 | 325,882 | 254,682 | |||||||||||||
| Operating income | 45,029 | 22,655 | 150,638 | 87,059 | |||||||||||||
| Other expense | (782 | ) | (61 | ) | (1,627 | ) | (350 | ) | |||||||||
| Debt exchange expense | - | - | - | (3,395 | ) | ||||||||||||
| Income before income taxes | 44,247 | 22,594 | 149,011 | 83,314 | |||||||||||||
| Income tax provision (benefit) | 17,797 | (214,533 | ) | 51,981 | (211,852 | ) | |||||||||||
| Net income | $ | 26,450 | $ | 237,127 | $ | 97,030 | $ | 295,166 | |||||||||
| Earnings per common share | |||||||||||||||||
| Basic | $ | 0.29 | $ | 2.70 | $ | 1.09 | $ | 3.46 | |||||||||
| Diluted | $ | 0.28 | $ | 2.59 | $ | 1.04 | $ | 3.26 | |||||||||
| Shares used in computing earnings per common share | |||||||||||||||||
| Basic | 90,068 | 87,885 | 89,271 | 85,326 | |||||||||||||
| Diluted | 94,293 | 91,449 | 93,037 | 90,582 | |||||||||||||
|
(1 |
) |
The following represents share-based compensation expense included in the respective captions of the |
||||||||||||||
|
|
condensed consolidated statements of operations above: | |||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| Share-based compensation expense: | ||||||||||||||||
| Cost of sales | $ | 411 | $ | - | $ | 1,266 | $ | - | ||||||||
| Research and development | 1,739 | 2,886 | 7,878 | 9,049 | ||||||||||||
| Selling, general and administrative | 5,455 | 3,992 | 23,194 | 19,682 | ||||||||||||
| $ | 7,605 | $ | 6,878 | $ | 32,338 | $ | 28,731 | |||||||||
| ALEXION PHARMACEUTICALS, INC. | ||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| (in thousands) | ||||||
| (unaudited) | ||||||
| December 31, | December 31, | |||||
| 2010 | 2009 | |||||
| Cash, cash equivalents and marketable securities | $ | 361,605 | $ | 176,220 | ||
| Trade accounts receivable, net | 168,732 | 113,731 | ||||
| Inventories, net | 62,165 | 40,885 | ||||
| Deferred tax assets, current | 19,643 | 16,726 | ||||
| Other current assets | 34,411 | 25,894 | ||||
| Property, plant and equipment, net | 162,240 | 164,691 | ||||
| Deferred tax assets, noncurrent | 154,569 | 194,308 | ||||
| Other noncurrent assets | 48,672 | 53,946 | ||||
| Total assets | $ | 1,012,037 | $ | 786,401 | ||
| Accounts payable and accrued expenses | $ | 123,056 | $ | 78,445 | ||
| Other current liabilities | 15,459 | 6,817 | ||||
| Long term debt | 3,718 | 9,918 | ||||
| Other noncurrent liabilities | 10,068 | 2,865 | ||||
| Total liabilities | 152,301 | 98,045 | ||||
| Total stockholders' equity | 859,736 | 688,356 | ||||
| Total liabilities and stockholders' equity | $ | 1,012,037 | $ | 786,401 | ||
Sr.
Director, Corporate Communications
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