- Soliris® (eculizumab) Net Product Sales Increased 37 Percent to
- 2013 Non-GAAP EPS Increased 47 Percent to
- Steady Soliris Growth in PNH Worldwide -
- aHUS Launch Progresses in U.S. and
- Strong Progress Across Lead Development Programs -
- Establishment of mRNA Research Capabilities Through Strategic Agreement With Moderna Therapeutics -
- 2014 Guidance: Revenue
Full Year 2013 Financial Highlights
-
2013 net product sales increased 37 percent to
$1.551 billion , compared to$1.134 billion in 2012. -
2013 GAAP net income was
$252.9 million , or$1.27 per share, which was impacted by$0.48 per share related to a non-cash tax expense associated with centralizing certain business operations and$0.17 per share related to impairment of intangible assets. 2012 GAAP net income was$254.8 million , or$1.28 per share. -
2013 non-GAAP net income increased 47 percent to
$624.2 million , or$3.08 per share, compared to 2012 non-GAAP net income of$425.2 million , or$2.13 per share.
Fourth Quarter 2013 Financial Highlights
-
Q4 2013 net product sales increased 38 percent to
$441.9 million , compared to$320.5 million in Q4 2012. -
Q4 2013 GAAP net loss was
$19.0 million , or$0.10 per share, which was impacted by$0.48 per share related to a non-cash tax expense associated with centralizing certain business operations and$0.17 per share related to impairment of intangible assets. Q4 2012 GAAP net income was$81.0 million , or$0.40 per share. -
Q4 2013 non-GAAP net income increased 45 percent to
$177.7 million , or$0.87 per share, compared to Q4 2012 non-GAAP net income of$122.3 million , or$0.60 per share.
Soliris is approved in nearly 50 countries for the treatment of patients
with PNH, including
Alexion's non-GAAP operating results are GAAP operating results adjusted for the impact of certain items described below. A full reconciliation of GAAP to non-GAAP financial results is included later in this press release.
Full Year 2013 Non-GAAP Financial Results
The Company
reported non-GAAP net income of
Alexion's non-GAAP operating expenses for the full year 2013 were
Full Year 2013 GAAP Financial Results
Alexion reported GAAP
net income of
Alexion's GAAP operating expenses for the full year 2013 were
Fourth Quarter Non-GAAP Financial Results
The Company
reported non-GAAP net income of
Alexion's non-GAAP operating expenses for Q4 2013 were
Fourth Quarter GAAP Financial Results
Alexion reported a
GAAP net loss of
On a GAAP basis, operating expenses for Q4 2013 were
Balance Sheet
As of
"In 2013, we provided Soliris to an increasing number of patients with
PNH and aHUS worldwide. We demonstrated steady growth in PNH, grew
steadily the number of new patients with aHUS receiving Soliris in the
U.S. and the first countries of
Research and Development Progress
Alexion
currently has development programs underway with eculizumab (Soliris)
and additional highly innovative therapeutic candidates that have the
potential to become first-in-class therapies for patients with severe
and ultra-rare disorders.
Ultra-Rare Disease Programs With Eculizumab
- Transplant: Antibody-Mediated Rejection (AMR) - Enrollment is ongoing in the Company-sponsored, multinational living-donor kidney transplant trial in patients at elevated risk of AMR and in the expanded Company-sponsored, multinational deceased-donor kidney transplant trial in patients at elevated risk of AMR.
-
Transplant: Delayed Graft Function (DGF) - Alexion is planning
to commence a single, multinational registration trial for the
prevention of delayed graft function (DGF) in renal transplant
patients. Earlier this month, eculizumab received an orphan drug
designation from the
U.S. Food and Drug Administration (FDA) for the prevention of delayed graft function (DGF) in renal transplant patients.
- Neurology: Neuromyelitis Optica (NMO) - Alexion is planning to commence a single, multinational, placebo-controlled, registration trial in relapsing NMO.
- Neurology: Myasthenia Gravis (MG) - Alexion is planning to commence a single, multinational, placebo-controlled, registration trial in severe, refractory MG.
Ultra-Rare Disease Programs with Additional Highly Innovative Therapeutics
- Asfotase Alfa: Alexion is developing asfotase alfa as a treatment for patients with pediatric-onset hypophosphatasia (HPP), an ultra-rare, inherited and life-threatening metabolic disease. The Company received Breakthrough Therapy designation for asfotase alfa in pediatric-onset HPP in Q2 2013. Alexion completed the initial analysis of its natural history study in infants with HPP and has now initiated a natural history study in juveniles with HPP.
- cPMP Replacement Therapy (ALXN 1101): Alexion is developing cPMP as a treatment for patients with Molybdenum Cofactor Deficiency (MoCD) Type A, a severe, ultra-rare and genetic metabolic disorder that causes catastrophic and irreversible neurologic damage within the first few weeks of life. The Company received Breakthrough Therapy designation for cPMP replacement therapy for patients with MoCD Type A in Q3 2013. A natural history study in MoCD patients is ongoing and Alexion plans to initiate a synthetic cPMP bridging study.
- ALXN1007: Alexion is preparing to commence two Phase 2 proof-of-concept studies of ALXN1007, a novel anti-inflammatory antibody, in severe and life-threatening ultra-rare disorders.
Establishment of mRNA Research Capabilities
Beyond its current development programs, the Company announced
on
2014 Financial Guidance
In 2014, 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 is approved in the
U.S. (2007),
More information including the full U.S. prescribing information on Soliris is available at www.soliris.net.
About Alexion
Alexion is a biopharmaceutical company
focused on serving patients with severe and rare disorders through the
innovation, development and commercialization of life-transforming
therapeutic products. Alexion is the global leader in complement
inhibition and has developed and markets Soliris® (eculizumab) as a
treatment for patients with PNH and aHUS, two debilitating, ultra-rare
and life-threatening disorders caused by chronic uncontrolled complement
activation. Soliris is currently approved in nearly 50 countries for the
treatment of PNH, and in
[ALXN-E]
This news release contains forward-looking statements, including
statements related to guidance regarding anticipated financial results
for 2014, 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, medical and
commercial potential of Alexion's complement-inhibition technology and
other technologies, and plans for clinical programs for each of our
product candidates. 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,
interruptions or failures in the manufacture and supply of Soliris and
our product candidates, progress in establishing and developing
commercial infrastructure, failure to satisfactorily address the issues
raised by the
In addition to financial information prepared in accordance with
GAAP, this news release also contains non-GAAP financial measures that
Alexion believes, when considered together with the GAAP information,
provide investors and management with supplemental information relating
to performance, trends and prospects that promote a more complete
understanding of our operating results and financial position during
different periods. The non-GAAP results exclude the impact of the
following GAAP items: share-based compensation expense,
acquisition-related costs, amortization of purchased intangible assets,
intellectual property settlements, upfront and milestone payments
related to license and collaboration agreements, intangible asset
impairments, non-cash taxes, and taxes related to acquisition
structuring. These non-GAAP financial measures are not intended to be
considered in isolation or as a substitute for, or superior to, the
financial measures prepared and presented in accordance with GAAP and
should be reviewed in conjunction with the relevant GAAP financial
measures. Please refer to the attached Reconciliation of GAAP to
Non-GAAP Net Income for explanations of the amounts adjusted to arrive
at non-GAAP net income and non-GAAP earnings per share amounts for the
three and twelve month periods ended
|
|
|||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||||||
| (unaudited) | |||||||||||||||||||
| Three months ended | Twelve months ended | ||||||||||||||||||
|
|
|
||||||||||||||||||
|
2013 |
2012 |
2013 | 2012 | ||||||||||||||||
| Net product sales | $ | 441,909 | $ | 320,526 | $ | 1,551,346 | $ | 1,134,114 | |||||||||||
| Cost of sales: | |||||||||||||||||||
| Cost of sales | 51,552 | 33,147 | 168,375 | 126,214 | |||||||||||||||
| Change in contingent liability from intellectual property settlements | - | - | 9,181 | (53,377 | ) | ||||||||||||||
| Total cost of sales | 51,552 | 33,147 | 177,556 | 72,837 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 85,785 | 63,409 | 317,093 | 222,732 | |||||||||||||||
| Selling, general and administrative | 134,819 | 112,624 | 489,720 | 384,678 | |||||||||||||||
| Acquisition-related costs | (1,945 | ) | 3,365 | 5,029 | 22,812 | ||||||||||||||
| Impairment of intangible assets | 33,521 | - | 33,521 | 26,300 | |||||||||||||||
| Amortization of purchased intangible assets | 105 | 105 | 417 | 417 | |||||||||||||||
| Total operating expenses | 252,285 | 179,503 | 845,780 | 656,939 | |||||||||||||||
| Operating income | 138,072 | 107,876 | 528,010 | 404,338 | |||||||||||||||
|
Other expense |
95 |
|
606 |
|
1,741 |
|
6,772 |
|
|||||||||||
| Income before income taxes | 137,977 | 107,270 | 526,269 | 397,566 | |||||||||||||||
| Income tax provision |
156,969 |
26,298 | 273,374 | 142,744 | |||||||||||||||
|
Net income (loss) |
$ |
(18,992 |
) | $ | 80,972 | $ | 252,895 | $ | 254,822 | ||||||||||
|
Earnings (loss) per common share |
|||||||||||||||||||
| Basic | $ | (0.10 | ) | $ | 0.42 | $ | 1.29 | $ | 1.34 | ||||||||||
| Diluted | $ | (0.10 | ) | $ | 0.40 | $ | 1.27 | $ | 1.28 | ||||||||||
|
Shares used in computing earnings (loss) per common share |
|||||||||||||||||||
| Basic | 196,430 | 194,141 | 195,532 | 190,461 | |||||||||||||||
| Diluted | 196,430 | 201,061 | 199,712 | 198,501 | |||||||||||||||
|
|
||||||||||||||||||||||
| RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS | ||||||||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||||||||
| (unaudited) | ||||||||||||||||||||||
| Three months ended | Twelve months ended | |||||||||||||||||||||
|
|
|
|||||||||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||||||||
|
Net income (loss) reconciliation: |
||||||||||||||||||||||
|
GAAP net income (loss) |
$ |
(18,992 |
) | $ | 80,972 | $ | 252,895 | $ | 254,822 | |||||||||||||
| Share-based compensation expense | 19,794 | 13,691 | 76,203 | 54,013 | ||||||||||||||||||
| Acquisition-related costs (1) | (1,945 | ) | 3,365 | 5,029 | 22,812 | |||||||||||||||||
| Amortization of purchased intangible assets | 105 | 105 | 417 | 417 | ||||||||||||||||||
| Change in contingent liability from intellectual property settlements (2) | - | - | 9,181 | (53,377 | ) | |||||||||||||||||
| Upfront and milestone payments related to license and collaboration agreements (3) | - | - | 14,500 | - | ||||||||||||||||||
| Impairment of intangible assets (4) | 33,521 | - | 33,521 | 26,300 | ||||||||||||||||||
| Non-cash taxes (5) | 145,266 | 24,158 | 232,460 | 98,364 | ||||||||||||||||||
| Taxes related to acquisition structuring (6) | - | - | - | 21,812 | ||||||||||||||||||
| Non-GAAP net income | $ |
177,749 |
$ | 122,291 | $ | 624,206 | $ | 425,163 | ||||||||||||||
|
GAAP earnings (loss) per share - diluted |
$ | (0.10 | ) | $ | 0.40 | $ | 1.27 | $ | 1.28 | |||||||||||||
| Non-GAAP earnings per share - diluted | $ | 0.87 | $ | 0.60 | $ | 3.08 | $ | 2.13 | ||||||||||||||
|
Shares used in computing diluted earnings (loss) per share (GAAP) |
196,430 | 201,061 | 199,712 | 198,501 | ||||||||||||||||||
| Shares used in computing diluted earnings per share (non-GAAP) | 203,586 | 202,249 | 202,943 | 199,787 | ||||||||||||||||||
| Cost of sales reconciliation: | ||||||||||||||||||||||
| GAAP cost of sales | $ | 51,552 | $ | 33,147 | $ | 177,556 | $ | 72,837 | ||||||||||||||
| Share-based compensation expense | (865 | ) | (876 | ) | (3,214 | ) | (2,815 | ) | ||||||||||||||
| Change in contingent liability from intellectual property settlements (2) | - | - | (9,181 | ) | 53,377 | |||||||||||||||||
| Non-GAAP cost of sales | $ | 50,687 | $ | 32,271 | $ | 165,161 | $ | 123,399 | ||||||||||||||
| Research and development reconciliation: | ||||||||||||||||||||||
| GAAP research and development | $ | 85,785 | $ | 63,409 | $ | 317,093 | $ | 222,732 | ||||||||||||||
| Share-based compensation expense | (5,944 | ) | (3,466 | ) | (23,905 | ) | (13,839 | ) | ||||||||||||||
| Upfront and milestone payments related to license and collaboration agreements (3) | - | - | (14,500 | ) | - | |||||||||||||||||
| Non-GAAP research and development | $ | 79,841 | $ | 59,943 | $ | 278,688 | $ | 208,893 | ||||||||||||||
|
Selling, general and administrative reconciliation: |
||||||||||||||||||||||
| GAAP selling, general and administrative | $ | 134,819 | $ | 112,624 | $ | 489,720 | $ | 384,678 | ||||||||||||||
| Share-based compensation expense | (12,985 | ) | (9,349 | ) | (49,084 | ) | (37,359 | ) | ||||||||||||||
| Non-GAAP selling, general and administrative | $ | 121,834 | $ | 103,275 | $ | 440,636 | $ | 347,319 | ||||||||||||||
| Income tax provision reconciliation: | ||||||||||||||||||||||
| GAAP income tax provision | $ |
156,969 |
$ | 26,298 | $ | 273,374 | $ | 142,744 | ||||||||||||||
|
Non-cash taxes (5) |
(145,266 | ) | (24,158 | ) | (232,460 | ) | (98,364 | ) | ||||||||||||||
| Taxes related to acquisition structuring (6) | - | - | - | (21,812 | ) | |||||||||||||||||
| Non-GAAP income tax provision | $ |
11,703 |
$ | 2,140 | $ | 40,914 | $ | 22,568 | ||||||||||||||
| (1 | ) | The following table summarizes acquisition-related costs: | ||||||||||||||||||||
| Three months ended | Twelve months ended | |||||||||||||||||||||
|
|
|
|
||||||||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||||||||
| Acquisition-related costs: | ||||||||||||||||||||||
| Separately-identifiable employee costs | $ | - | $ | 117 | $ | 248 | $ | 3,669 | ||||||||||||||
| Professional fees | - | 1,031 | 775 | 12,593 | ||||||||||||||||||
| Changes in fair value of contingent consideration | (1,945 | ) | 2,217 | 4,006 | 6,550 | |||||||||||||||||
| $ | (1,945 | ) | $ | 3,365 | $ | 5,029 | $ | 22,812 | ||||||||||||||
| (2) |
In
In |
|
| (3) |
In
In |
|
| (4) |
During the three and twelve months ended
During the twelve months ended |
|
| (5) |
Non-cash taxes represents the adjustment from GAAP tax expense to
the amount of taxes that are payable in cash on our operating
profits.
The adjustment includes tax amounts that are not currently payable
in cash due to the continued utilization of our US net operating
losses and credits. In addition, during the three and twelve
months ended |
|
| (6) |
The tax provision for the twelve months ended |
|
|
|
||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
|
|
|
|||||||
| 2013 | 2012 | |||||||
| Cash and cash equivalents | $ | 529,857 | $ | 989,501 | ||||
| Marketable securities | 984,994 | - | ||||||
| Trade accounts receivable, net | 421,752 | 295,598 | ||||||
| Inventories | 102,602 | 94,521 | ||||||
| Deferred tax assets, current | 41,432 | 26,086 | ||||||
| Other current assets |
106,220 |
89,894 | ||||||
| Property, plant and equipment, net | 201,109 | 165,629 | ||||||
| Deferred tax assets, noncurrent | 3,394 | 13,954 | ||||||
| Intangible assets, net | 609,719 | 646,678 | ||||||
| Goodwill | 254,073 | 253,645 | ||||||
| Other noncurrent assets |
62,544 |
38,054 | ||||||
| Total assets | $ |
3,317,696 |
$ | 2,613,560 | ||||
| Accounts payable and accrued expenses | $ |
423,940 |
$ | 271,275 | ||||
| Current portion of long-term debt | 48,000 | 48,000 | ||||||
| Other current liabilities |
110,489 |
40,814 | ||||||
| Long-term debt, less current portion | 65,000 | 101,000 | ||||||
| Contingent consideration, noncurrent | 106,744 | 139,002 | ||||||
|
Deferred tax liabilities, noncurrent |
101,241 |
19,827 |
||||||
| Other noncurrent liabilities | 80,203 |
22,792 |
||||||
| Total liabilities |
935,617 |
642,710 | ||||||
| Total stockholders' equity | 2,382,079 | 1,970,850 | ||||||
| Total liabilities and stockholders' equity | $ |
3,317,696 |
$ | 2,613,560 | ||||
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