- Soliris® (eculizumab) Net Product Sales Increased 45 Percent to
- Continued Steady Growth of Soliris in PNH —
- aHUS Launch Progresses with Increasing Number of New Patients Starting on Soliris —
- Pipeline Advances with Five Therapeutic Candidates Targeting Severe and Ultra-Rare Disorders -
Fourth Quarter 2012 Financial Highlights:
-
Q4 2012 net product sales increased 41 percent to
$320.5 million , compared to$227.6 million in Q4 2011. -
Q4 2012 GAAP net income increased 68 percent to
$81.0 million , or$0.40 per share, compared to Q4 2011 GAAP net income of$48.2 million , or$0.25 per share. -
Q4 2012 non-GAAP net income increased 52 percent to
$122.3 million , or$0.60 per share, compared to Q4 2011 non-GAAP net income of$80.5 million , or$0.41 per share.
Full-Year 2012 Financial Highlights:
-
2012 net product sales increased 45 percent to
$1.134 billion , compared to$783.4 million in 2011. -
2012 GAAP net income increased 45 percent to
$254.8 million , or$1.28 per share, compared to 2011 GAAP net income of$175.3 million , or$0.91 per share. -
2012 non-GAAP net income increased 60 percent to
$425.2 million , or$2.13 per share, compared to 2011 non-GAAP net income of$266.1 million , or$1.38 per share.
Soliris is approved for patients with PNH in the US,
Alexion's non-GAAP operating results are equal to GAAP operating results adjusted for the impact of share-based compensation expense, acquisition-related costs, taxes related to acquisition structuring, intellectual property settlements, intangible asset impairments and non-cash taxes. A full reconciliation of non-GAAP results is included later in this press release.
Fourth Quarter Non-GAAP Financial Results:
The Company reported non-GAAP net income of
Alexion's non-GAAP operating expenses for Q4 2012 were
Fourth Quarter GAAP Financial Results:
Alexion reported GAAP net income of
On a GAAP basis, operating expenses for Q4 2012 were
Full Year 2012 Non-GAAP Financial Results:
The Company reported non-GAAP net income of
Alexion's non-GAAP operating expenses for the full year 2012 were
Full Year 2012 GAAP Financial Results:
Alexion reported GAAP net income of
Alexion's GAAP operating expenses for the full year 2012 were
Balance Sheet:
As of
"In 2012, we continued to expand the global presence of our PNH
operations as we also commenced our activities to transform the lives of
patients suffering with aHUS," said
Research and Development Progress:
Alexion currently has development programs underway with its five highly innovative therapeutic candidates: eculizumab (Soliris) and four additional novel therapeutic candidates beyond eculizumab that have the potential to become first-in-class therapies for patients with other severe and ultra-rare disorders.
Ultra-Rare Disease Programs With Eculizumab
-
Nephrology- STEC-HUS: Data from the full cohort of 198 enrolled
patients in the Company-sponsored
Shiga -toxin-producing E. coli hemolytic uremic syndrome (STEC-HUS) trial were presented at theAmerican Society of Nephrology (ASN) meeting. Preliminary findings from an exploratory post hoc, matched-control analysis of patients with severe STEC-HUS receiving eculizumab versus other patients who received only best supportive care during the German epidemic were also reported at ASN. - Nephrology- Kidney Transplant: Eculizumab is now being evaluated in two different potential kidney transplant indications. Enrollment is ongoing in Company-sponsored, multi-national, living-donor and deceased-donor kidney transplant trials in patients at elevated risk of Acute Humoral Rejection (AHR), also known as antibody mediated rejection. Alexion is also expanding its kidney transplant program to include a delayed-graft function (DGF) clinical trial.
-
Neurology- NMO: The Company has commenced discussions with
regulators in both
the United States andEurope to discuss plans for a Company-sponsored multi-national, placebo-controlled, registration trial in relapsing neuromyelitis optica (NMO). - Neurology- MG: Alexion continues to work with investigators to design the next clinical trial to evaluate eculizumab as a treatment for patients with severe myasthenia gravis (MG).
Ultra-Rare Disease Programs With Highly Innovative Therapeutic Candidates Beyond Eculizumab
- Asfotase Alfa: A natural history study is ongoing in infants with hypophosphatasia (HPP), an ultra-rare, inherited and life-threatening metabolic disease. The Company is also completing optimization of the manufacturing process for asfotase alfa.
- cPMP Replacement Therapy: Alexion is developing a cPMP replacement therapy for the treatment of patients with Molybdenum Cofactor Deficiency Type A, a severe, ultra-rare and genetic metabolic disorder that is fatal in newborns. The Company continues to accelerate the regulatory and manufacturing processes for this therapeutic candidate and expects to initiate clinical studies in mid-2013.
- ALXN1102/ALXN1103: Enrollment continues in a Phase I study to characterize the mechanism of action and develop initial safety data for ALXN1102 and ALXN1103, intravenous and sub-cutaneous versions, respectively, of one of Alexion's novel complement inhibitors.
- ALXN1007: The Company has completed dosing in a Phase I study of ALXN1007, a novel anti-inflammatory antibody, to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of this therapeutic candidate in healthy volunteers.
2013 Financial Guidance:
In 2013, 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 US,
About Alexion:
[ALXN-E]
This news release contains forward-looking statements, including
statements related to guidance regarding anticipated financial results
for 2013, 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 and progress in developing commercial infrastructure.
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 acquisitions will
not result in short-term or long-term benefits, the possibility that
current 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 or
continue to 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 are inaccurate, and a variety of other risks set
forth from time to time in Alexion's filings with the
In addition to financial information prepared in accordance with
GAAP, this news release also contains non-GAAP financial measures that
we believe, 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. 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
(Tables Follow)
|
|
|||||||||||||||||||||
| Three months ended | Twelve months ended | ||||||||||||||||||||
|
|
|
||||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||||||||
| Net product sales | $ | 320,526 | $ | 227,559 | $ | 1,134,114 | $ | 783,431 | |||||||||||||
| Cost of sales |
33,147 |
28,798 | 126,214 | 93,140 | |||||||||||||||||
| Gain on intellectual property settlement | - | - | (53,377 | ) | - | ||||||||||||||||
| Total cost of sales |
33,147 |
28,798 | 72,837 | 93,140 | |||||||||||||||||
| Research and development |
63,409 |
34,398 | 222,732 | 137,421 | |||||||||||||||||
| Selling, general and administrative |
112,624 |
86,567 | 384,678 | 308,176 | |||||||||||||||||
| Impairment of intangible asset | - | - | 26,300 | - | |||||||||||||||||
| Acquisition-related costs | 3,365 | 2,322 | 22,812 | 13,486 | |||||||||||||||||
| Amortization of purchased intangible assets |
105 |
104 | 417 | 382 | |||||||||||||||||
| Total operating expenses |
179,503 |
123,391 | 656,939 | 459,465 | |||||||||||||||||
| Operating income |
107,876 |
75,370 | 404,338 | 230,826 | |||||||||||||||||
| Interest and other expense |
606 |
|
1,292 |
|
6,772 |
|
1,158 |
|
|||||||||||||
| Income before income taxes |
107,270 |
74,078 | 397,566 | 229,668 | |||||||||||||||||
| Income tax provision | 26,298 | 25,908 | 142,744 | 54,353 | |||||||||||||||||
| Net income | $ |
80,972 |
$ | 48,170 | $ | 254,822 | $ | 175,315 | |||||||||||||
| Earnings per common share | |||||||||||||||||||||
| Basic | $ | 0.42 | $ | 0.26 | $ | 1.34 | $ | 0.96 | |||||||||||||
| Diluted | $ | 0.40 | $ | 0.25 | $ | 1.28 | $ | 0.91 | |||||||||||||
| Shares used in computing earnings per common share | |||||||||||||||||||||
| Basic | 194,141 | 184,452 | 190,461 | 183,220 | |||||||||||||||||
| Diluted | 201,061 | 193,370 | 198,501 | 191,806 | |||||||||||||||||
|
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
|||||||||||||||||||
| Three months ended | Twelve months ended | ||||||||||||||||||
|
|
|
||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||||||
| GAAP net income | $ |
80,972 |
$ | 48,170 | $ | 254,822 | $ | 175,315 | |||||||||||
| Share-based compensation expense (1) | 13,691 | 10,337 | 54,013 | 44,763 | |||||||||||||||
| Acquisition-related costs (2) | 3,365 | 2,322 | 22,812 | 13,486 | |||||||||||||||
| Amortization of purchased intangible assets |
105 |
104 | 417 | 382 | |||||||||||||||
| Non-cash taxes (3) |
24,158 |
19,547 |
98,364 |
32,155 | |||||||||||||||
| Tax related to acquisition structuring (4) |
- |
- |
21,812 |
- | |||||||||||||||
| Gain on intellectual property settlement (5) |
- |
- | (53,377 | ) | - | ||||||||||||||
| Impairment of intangible asset (6) | - | - | 26,300 | - | |||||||||||||||
| Non-GAAP net income | $ |
122,291 |
$ | 80,480 | $ | 425,163 | $ | 266,101 | |||||||||||
| Shares used in computing diluted earnings per share (GAAP) | 201,061 | 193,370 | 198,501 | 191,806 | |||||||||||||||
| Shares used in computing diluted earnings per share (non-GAAP) | 202,249 | 194,732 | 199,787 | 193,539 | |||||||||||||||
| GAAP earnings per share - diluted | $ | 0.40 | $ | 0.25 | $ | 1.28 | $ | 0.91 | |||||||||||
| Non-GAAP earnings per share - diluted | $ | 0.60 | $ | 0.41 | $ | 2.13 | $ | 1.38 | |||||||||||
| (1) |
The following table summarizes the share-based compensation expense for each expense category in our condensed consolidated statements of operations: |
|
| Three months ended | Twelve months ended | |||||||||||||||||||
|
|
|
|||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||||||
| Share-based compensation expense: | ||||||||||||||||||||
| Cost of sales | $ | 876 | $ | 613 | $ | 2,815 | $ | 2,375 | ||||||||||||
| Research and development | 3,466 | 2,270 | 13,839 | 9,759 | ||||||||||||||||
| Selling, general and administrative | 9,349 | 7,454 | 37,359 | 32,629 | ||||||||||||||||
| $ | 13,691 | $ | 10,337 | $ | 54,013 | $ | 44,763 | |||||||||||||
| (2 | ) | The following table summarizes acquisition-related costs: | ||||||||||||||||||
| Three months ended | Twelve months ended | |||||||||||||||||||
|
|
|
|||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||||||
| Acquisition-related costs: | ||||||||||||||||||||
| Separately-identifiable employee costs | $ | 117 | $ | - | $ | 3,669 | $ | 6,597 | ||||||||||||
| Professional fees | 1,031 | 2,039 | 12,593 | 5,489 | ||||||||||||||||
| Changes in fair value of contingent consideration | 2,217 | 283 | 6,550 | 1,400 | ||||||||||||||||
| $ | 3,365 | $ | 2,322 | $ | 22,812 | $ | 13,486 | |||||||||||||
| (3) |
Non-cash taxes represents the adjustment from GAAP tax expense to the amount of taxes that are payable in cash. 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 the third quarter of 2011, we elected to claim foreign tax and
orphan drug credits resulting in a tax benefit of |
||
| (4) |
The tax provision for the twelve months ended |
|
| (5) |
In |
|
| (6) |
During the three months ended |
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) |
||||||||||
|
|
December 31, | |||||||||
| 2012 | 2011 | |||||||||
| Cash and cash equivalents | $ | 989,501 | $ | 540,865 | ||||||
| Trade accounts receivable, net | 295,598 | 244,288 | ||||||||
| Inventories, net | 94,521 | 81,386 | ||||||||
| Deferred tax assets, current | 26,086 | 19,132 | ||||||||
| Other current assets | 89,894 | 55,599 | ||||||||
| Property, plant and equipment, net | 165,629 | 165,852 | ||||||||
| Deferred tax assets, noncurrent | 13,954 | 103,868 | ||||||||
| Intangible assets, net | 646,678 | 91,604 | ||||||||
| Goodwill | 253,645 | 79,639 | ||||||||
| Other noncurrent assets | 38,054 | 12,518 | ||||||||
| Total assets | $ | 2,613,560 | $ | 1,394,751 | ||||||
| Accounts payable and accrued expenses | $ |
271,275 |
$ | 199,653 | ||||||
| Current portion of long-term debt | 48,000 | - | ||||||||
| Other current liabilities |
40,814 |
28,132 | ||||||||
| Long-term debt | 101,000 | - | ||||||||
| Contingent consideration | 139,002 | 18,120 | ||||||||
| Other noncurrent liabilities | 42,619 | 14,354 | ||||||||
| Total liabilities | 642,710 | 260,259 | ||||||||
| Total stockholders' equity | 1,970,850 | 1,134,492 | ||||||||
| Total liabilities and stockholders' equity | $ | 2,613,560 | $ | 1,394,751 | ||||||
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