Soliris® (eculizumab) Net Product Sales
Increased 38 Percent vs.
Continued Steady Growth in PNH; aHUS Launch Progressing
Guidance Revised Upward for Revenues and Non-GAAP EPS
Deceased-Donor Kidney Transplant Trial Enrollment Completed
Hypophosphatasia Infant Natural History Study Enrollment Completed
Single Myasthenia Gravis Registration Trial Now Planned
Retrospective cPMP Clinical Study in MoCD Commenced; First Study With Synthetic cPMP Planned
First Quarter 2013 Financial Highlights:
-
Q1 2013 net product sales increased 38 percent to
$338.9 million , compared to$244.7 million in Q1 2012.
-
Q1 2013 GAAP net income increased 81 percent to
$82.2 million , or$0.41 per share, compared to Q1 2012 GAAP net income of$45.4 million , or$0.23 per share. -
Q1 2013 non-GAAP net income increased 49 percent to
$131.3 million , or$0.65 per share, compared to Q1 2012 non-GAAP net income of$88.1 million , or$0.45 per share.
"The first quarter was particularly noteworthy for the significant
progress across our lead development programs. This included completing
enrollment in the deceased-donor kidney transplant trial and the
hypophosphatasia infant natural history study, initiating plans for a
single myasthenia gravis registration trial, and accelerating our cPMP
clinical programs," said
First Quarter 2013 Financial Results:
Alexion's non-GAAP operating results are GAAP operating results adjusted for the impact of certain items described below. A full reconciliation of GAAP results to non-GAAP results is included later in this press release.
First Quarter 2013 Non-GAAP Financial Results:
The Company reported non-GAAP net income of
Alexion's non-GAAP operating expenses for Q1 2013 were
First Quarter 2013 GAAP Financial Results:
Alexion reported GAAP net income of
On a GAAP basis, operating expenses for Q1 2013 were
Balance Sheet:
As of
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
- Neurology: NMO - Alexion is preparing to commence what it expects to be a single Company-sponsored, multi-national, placebo-controlled, registration trial in relapsing neuromyelitis optica (NMO).
- Neurology: MG — Alexion is also preparing to commence what it expects to be a single Company-sponsored, multi-national, placebo-controlled, registration trial in severe refractory myasthenia gravis (MG).
- Nephrology: Kidney Transplant — Enrollment has now been completed in the Company-sponsored, multi-national deceased-donor kidney transplant trial in patients at elevated risk of antibody mediated rejection (AMR). Enrollment in the Company-sponsored, multi-national living-donor kidney transplant trial in patients at elevated risk of AMR is on-going. Alexion is also expanding its kidney transplant program to include a delayed-graft function (DGF) clinical trial.
- Nephrology: STEC-HUS — The Company is obtaining and analyzing additional longer-term control clinical outcome data from an epidemiologic study in approximately 400 STEC-HUS patients who received only best supportive care during the 2011 German epidemic.
Ultra-Rare Disease Programs with Highly Innovative Therapeutics Beyond Eculizumab
- Asfotase Alfa: Alexion completed enrollment in a retrospective natural history study in infants with hypophosphatasia (HPP), an ultra-rare, inherited and life-threatening metabolic disease.
- cPMP Replacement Therapy: Alexion is developing a cPMP replacement therapy for the treatment of patients with Molybdenum Cofactor Deficiency Type A (MoCD), a severe, ultra-rare and genetic metabolic disorder that is fatal in newborns. Alexion has commenced a retrospective cPMP study in MoCD patients and a study with the Company's synthetic cPMP is planned.
- ALXN1102/1103: Enrollment continues in a Phase I study to characterize the mechanism of action and develop initial safety data for ALXN1102 and ALXN1103, intravenous and subcutaneous versions, respectively, of one of Alexion's novel complement inhibitors.
- ALXN1007: Alexion has completed dosing in a single-dose 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. The Company expects to meet with regulators to discuss a multi-dose Phase I study.
2013 Financial Guidance:
Alexion today announced that it is raising its 2013 revenue guidance
from the previous range of
Conference Call/Web Cast Information:
Alexion will host a conference call/audio web cast 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,
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: the impact of share-based compensation expense,
acquisition-related costs, taxes related to acquisition structuring,
intangible asset impairments, upfront and milestone payments
related to licensing and collaboration agreements, and non-cash taxes.
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 month
periods ended
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|||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three months ended | |||||||||||||||
|
|
|||||||||||||||
| 2013 | 2012 | ||||||||||||||
| Net product sales | $ | 338,941 | $ | 244,733 | |||||||||||
| Cost of sales | 35,269 | 28,268 | |||||||||||||
| Research and development | 74,536 | 45,408 | |||||||||||||
| Selling, general and administrative | 108,826 | 87,242 | |||||||||||||
| Acquisition-related costs | 3,234 | 13,673 | |||||||||||||
| Amortization of purchased intangible assets | 104 | 104 | |||||||||||||
| Total operating expenses | 186,700 | 146,427 | |||||||||||||
| Operating income | 116,972 | 70,038 | |||||||||||||
| Interest and other expense | (231 | ) | (2,229 | ) | |||||||||||
| Income before income taxes | 116,741 | 67,809 | |||||||||||||
| Income tax provision | 34,524 | 22,396 | |||||||||||||
| Net income | $ | 82,217 | $ | 45,413 | |||||||||||
| Earnings per common share | |||||||||||||||
| Basic | $ | 0.42 | $ | 0.24 | |||||||||||
| Diluted | $ | 0.41 | $ | 0.23 | |||||||||||
| Shares used in computing earnings per common share | |||||||||||||||
| Basic | 194,771 | 185,682 | |||||||||||||
| Diluted | 199,057 | 194,560 | |||||||||||||
|
|
|||||||
| RECONCILIATION OF GAAP TO NON-GAAP NET INCOME | |||||||
| (in thousands, except per share amounts) | |||||||
| (unaudited) | |||||||
| Three months ended | |||||||
|
|
|||||||
| 2013 | 2012 | ||||||
| GAAP net income | $ | 82,217 | $ | 45,413 | |||
| Share-based compensation expense (1) | 16,855 | 13,318 | |||||
| Acquisition-related costs (2) | 3,234 | 13,673 | |||||
| Amortization of purchased intangible assets | 104 | 104 | |||||
|
Upfront and milestone payments related to license and |
|||||||
|
collaboration agreements (3) |
3,000 | - | |||||
| Non-cash taxes (4) | 25,904 | 15,553 | |||||
| Non-GAAP net income | $ | 131,314 | $ | 88,061 | |||
| Shares used in computing diluted earnings per share (GAAP) | 199,057 | 194,560 | |||||
| Shares used in computing diluted earnings per share (non-GAAP) | 202,225 | 195,895 | |||||
| GAAP earnings per share - diluted | $ | 0.41 | $ | 0.23 | |||
| Non-GAAP earnings per share - diluted | $ | 0.65 | $ | 0.45 | |||
| (1) | The following table summarizes the share-based compensation expense for each expense category in our condensed consolidated statements of operations: |
| Three months ended | |||||||||||||
|
|
|||||||||||||
| 2013 | 2012 | ||||||||||||
| Share-based compensation expense: | |||||||||||||
| Cost of sales | $ | 875 | $ | 603 | |||||||||
| Research and development | 5,090 | 3,349 | |||||||||||
| Selling, general and administrative | 10,890 | 9,366 | |||||||||||
| $ | 16,855 | $ | 13,318 | ||||||||||
| (2) | The following table summarizes acquisition-related costs: | ||||||||||||
| Three months ended | |||||||||||||
|
|
|||||||||||||
| 2013 | 2012 | ||||||||||||
| Acquisition-related costs: | |||||||||||||
| Separately-identifiable employee costs | $ | 248 | $ | 2,296 | |||||||||
| Professional fees | 775 | 8,469 | |||||||||||
| Changes in fair value of contingent consideration | 2,211 | 2,908 | |||||||||||
| $ | 3,234 | $ | 13,673 | ||||||||||
| (3) |
In |
|
| (4) | 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. |
|
|
|||||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||||
| (in thousands) | |||||||||||||
| (unaudited) | |||||||||||||
|
March 31 |
|
||||||||||||
|
2013 |
2012 | ||||||||||||
| Cash and cash equivalents | $ | 1,022,960 | $ | 989,501 | |||||||||
| Trade accounts receivable, net | 323,907 | 295,598 | |||||||||||
| Inventories, net | 101,856 | 94,521 | |||||||||||
| Deferred tax assets, current | 19,995 | 26,086 | |||||||||||
| Other current assets | 81,323 | 89,894 | |||||||||||
| Property, plant and equipment, net | 164,966 | 165,629 | |||||||||||
| Deferred tax assets, noncurrent | 11,980 | 13,954 | |||||||||||
| Intangible assets, net | 644,965 | 646,678 | |||||||||||
| Goodwill | 254,073 | 253,645 | |||||||||||
| Other noncurrent assets | 59,856 | 38,054 | |||||||||||
| Total assets | $ | 2,685,881 | $ | 2,613,560 | |||||||||
| Accounts payable and accrued expenses | $ | 212,545 | $ | 271,275 | |||||||||
| Current portion of long-term debt | 48,000 | 48,000 | |||||||||||
| Other current liabilities |
35,202 |
40,814 | |||||||||||
| Long-term debt | 101,000 | 101,000 | |||||||||||
| Contingent consideration | 141,181 | 139,002 | |||||||||||
| Other noncurrent liabilities |
57,900 |
42,619 | |||||||||||
| Total liabilities | 595,828 | 642,710 | |||||||||||
| Total stockholders' equity | 2,090,053 | 1,970,850 | |||||||||||
| Total liabilities and stockholders' equity | $ | 2,685,881 | $ | 2,613,560 | |||||||||
Executive
Director, Corporate Communications
or
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