- Soliris® (eculizumab) Net Product Sales Increased 38 Percent to
- EU Marketing Authorization Application for Asfotase Alfa Accepted by EMA; Accelerated Assessment Granted -
- Eculizumab MG Registration Trial Underway -
- Dosing Completed in Living-Donor and Deceased-Donor Eculizumab AMR Trials -
- 2014 Guidance Increased for Revenue and Non-GAAP EPS -
Second Quarter 2014 Financial Highlights:
- Q2 2014 net product sales increased 38 percent to
$512.5 million , compared to$370.1 million in Q2 2013.
- Q2 2014 GAAP net income increased 74 percent to
$166.5 million , or$0.83 per share, compared to Q2 2013 GAAP net income of$95.9 million , or$0.48 per share. - Q2 2014 non-GAAP net income increased 56 percent to
$229.1 million , or$1.12 per share, compared to Q2 2013 non-GAAP net income of$147.2 million , or$0.73 per share.
Alexion is serving patients with PNH and aHUS in nearly 50 countries. Both PNH and aHUS are severe and life-threatening ultra-rare disorders caused by chronic uncontrolled complement activation.
"In the second quarter of 2014, we served an increasing number of new patients with PNH and aHUS worldwide while simultaneously reaching several significant milestones across our pipeline, including the filing of our MAA for asfotase alfa for HPP in
Second Quarter 2014 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.
Second Quarter 2014 Non-GAAP Financial Results:
The Company reported non-GAAP net income of
Alexion's non-GAAP operating expenses for Q2 2014 were
Second Quarter 2014 GAAP Financial Results:
Alexion reported GAAP net income of
On a GAAP basis, operating expenses for Q2 2014 were
Balance Sheet:
As of
Research and Development Progress:
Alexion has development programs underway with highly innovative therapeutic candidates that have the potential to become first-in-class therapies for patients with severe and ultra-rare disorders.
Asfotase Alfa
- Alexion filed a marketing authorization application (MAA) for asfotase alfa, a targeted enzyme replacement therapy for the treatment of patients with hypophosphatasia (HPP), with the
European Medicines Agency (EMA) which has been validated and granted accelerated assessment. - The Company continues to add to the rolling Biologics License Application (BLA) submission with the
U.S. Food and Drug Administration (FDA). Alexion received Breakthrough Therapy designation from theFDA for asfotase alfa in 2013. - Additionally, a natural history study in juveniles with HPP is ongoing.
Ultra-Rare Disease Programs With Eculizumab
- Transplant: Antibody-Mediated Rejection (AMR) - Dosing has now been completed in the Company-sponsored, multinational living-donor kidney transplant trial in patients at elevated risk of AMR. Additionally, both enrollment and dosing have been completed 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 preparing to commence a single, multinational registration trial for the prevention of DGF in renal transplant patients.
- Neurology: Neuromyelitis Optica (NMO) - Enrollment and dosing are ongoing in a Company-sponsored single, multinational, placebo-controlled, registration trial in relapsing NMO.
- Neurology: Myasthenia Gravis (MG) - Enrollment and dosing are on-going in a single, multinational, placebo-controlled, registration trial in refractory MG.
Ultra-Rare Disease Programs with Additional Highly Innovative Therapeutics
- cPMP Replacement Therapy (ALXN 1101) - A natural history study in patients with molybdenum cofactor deficiency (MoCD) and a synthetic cPMP bridging study are both on-going. Alexion received Breakthrough Therapy designation for its cPMP replacement therapy in 2013, which is being developed for patients with MoCD Type A.
- ALXN1007 - Alexion has commenced screening in a Phase 2 proof-of-concept study of ALXN1007, a novel anti-inflammatory antibody, in patients with antiphospholipid syndrome (APS).
2014 Financial Guidance
Alexion today announced that the Company is revising upward its revenue guidance for 2014 from the previous range of
Alexion is reiterating the other elements of its 2014 financial guidance as provided in the press release issued on
Conference Call/Webcast Information:
Alexion will host a conference call/audio 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 nearly 40 countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. This press release and further information about Alexion can be found at www.alexionpharma.com.
[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, upfront and milestone payments related to license and collaboration agreements, intangible asset impairments, 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 Financial Results for explanations of the amounts adjusted to arrive at non-GAAP net income and non-GAAP earnings per share amounts for the three and six month periods ended
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Net product sales | $ | 512,495 | $ | 370,091 | $ | 1,079,111 | $ | 709,032 | ||||||||
| Cost of sales | 39,626 | 39,377 | 72,565 | 74,646 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 92,554 | 68,563 | 284,011 | 143,099 | ||||||||||||
| Selling, general and administrative | 159,477 | 123,189 | 288,768 | 232,015 | ||||||||||||
| Impairment of intangible asset | - | - | 3,464 | - | ||||||||||||
| Acquisition-related costs | 1,989 | 1,167 | 1,951 | 4,401 | ||||||||||||
| Amortization of purchased intangible assets | - | 104 | - | 208 | ||||||||||||
| Total operating expenses | 254,020 | 193,023 | 578,194 | 379,723 | ||||||||||||
| Operating income | 218,849 | 137,691 | 428,352 | 254,663 | ||||||||||||
| Other income (expense) | (203 | ) | (428 | ) | 2,205 | (659 | ) | |||||||||
| Income before income taxes | 218,646 | 137,263 | 430,557 | 254,004 | ||||||||||||
| Income tax provision | 52,151 | 41,378 | 104,708 | 75,902 | ||||||||||||
| Net income | $ | 166,495 | $ | 95,885 | $ | 325,849 | $ | 178,102 | ||||||||
| Earnings per common share | ||||||||||||||||
| Basic | $ | 0.84 | $ | 0.49 | $ | 1.65 | $ | 0.92 | ||||||||
| Diluted | $ | 0.83 | $ | 0.48 | $ | 1.62 | $ | 0.90 | ||||||||
| Shares used in computing earnings per common share | ||||||||||||||||
| Basic | 197,880 | 195,247 | 197,838 | 193,944 | ||||||||||||
| Diluted | 201,524 | 199,299 | 201,715 | 198,096 | ||||||||||||
| RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS | ||||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||||
| (unaudited) | ||||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||||
| Net income reconciliation: | ||||||||||||||||||
| GAAP net income | $ | 166,495 | $ | 95,885 | $ | 325,849 | $ | 178,102 | ||||||||||
| Share-based compensation expense | 28,414 | 17,957 | 52,254 | 34,812 | ||||||||||||||
| Acquisition-related costs (1) | 1,989 | 1,167 | 1,951 | 4,401 | ||||||||||||||
| Amortization of purchased intangible assets | - | 104 | - | 208 | ||||||||||||||
| Upfront and milestone payments related to license and collaboration agreements | - | - | 101,925 | 3,000 | ||||||||||||||
| Impairment of intangible asset | - | - | 3,464 | - | ||||||||||||||
| Non-cash taxes (2) | 32,174 | 32,117 | 56,228 | 58,021 | ||||||||||||||
| Non-GAAP net income | $ | 229,072 | $ | 147,230 | $ | 541,671 | $ | 278,544 | ||||||||||
| GAAP earnings per share - diluted | $ | 0.83 | $ | 0.48 | $ | 1.62 | $ | 0.90 | ||||||||||
| Non-GAAP earnings per share - diluted | $ | 1.12 | $ | 0.73 | $ | 2.65 | $ | 1.38 | ||||||||||
| Shares used in computing diluted earnings per share (GAAP) | 201,524 | 199,299 | 201,715 | 198,096 | ||||||||||||||
| Shares used in computing diluted earnings per share (non-GAAP) | 204,435 | 202,593 | 204,631 | 201,340 | ||||||||||||||
| Cost of sales reconciliation: | ||||||||||||||||||
| GAAP cost of sales | $ | 39,626 | $ | 39,377 | $ | 72,565 | $ | 74,646 | ||||||||||
| Share-based compensation expense | (964 | ) | (717 | ) | (1,847 | ) | (1,592 | ) | ||||||||||
| Non-GAAP cost of sales | $ | 38,662 | $ | 38,660 | $ | 70,718 | $ | 73,054 | ||||||||||
| Research and development reconciliation: | ||||||||||||||||||
| GAAP research and development | $ | 92,554 | $ | 68,563 | $ | 284,011 | $ | 143,099 | ||||||||||
| Share-based compensation expense | (7,453 | ) | (5,068 | ) | (15,437 | ) | (10,158 | ) | ||||||||||
| Upfront and milestone payments related to license and collaboration agreements | - | - | (101,925 | ) | (3,000 | ) | ||||||||||||
| Non-GAAP research and development | $ | 85,101 | $ | 63,495 | $ | 166,649 | $ | 129,941 | ||||||||||
| Selling, general and administrative reconciliation: | ||||||||||||||||||
| GAAP selling, general and administrative | $ | 159,477 | $ | 123,189 | $ | 288,768 | $ | 232,015 | ||||||||||
| Share-based compensation expense | (19,997 | ) | (12,172 | ) | (34,970 | ) | (23,062 | ) | ||||||||||
| Non-GAAP selling, general and administrative | $ | 139,480 | $ | 111,017 | $ | 253,798 | $ | 208,953 | ||||||||||
| Income tax provision reconciliation: | ||||||||||||||||||
| GAAP income tax provision | $ | 52,151 | $ | 41,378 | $ | 104,708 | $ | 75,902 | ||||||||||
| Non-cash taxes (2) | (32,174 | ) | (32,117 | ) | (56,228 | ) | (58,021 | ) | ||||||||||
| Non-GAAP income tax provision | $ | 19,977 | $ | 9,261 | $ | 48,480 | $ | 17,881 | ||||||||||
| (1) | The following table summarizes acquisition-related costs: | |||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||||
| Acquisition-related costs: | ||||||||||||||||||
| Separately-identifiable employee costs | $ | - | $ | - | $ | - | $ | 248 | ||||||||||
| Professional fees | - | - | - | 775 | ||||||||||||||
| Changes in fair value of contingent consideration | 1,989 | 1,167 | 1,951 | 3,378 | ||||||||||||||
| $ | 1,989 | $ | 1,167 | $ | 1,951 | $ | 4,401 | |||||||||||
| (2) | Non-cash taxes represents the adjustment from GAAP tax expense to the amount of taxes that are payable in cash in the current period. | |
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
| (in thousands) | ||||||||||
| (unaudited) | ||||||||||
|
June 30, |
||||||||||
| 2014 | 2013 | |||||||||
| Cash and cash equivalents | $ | 612,045 | $ | 529,857 | ||||||
| Marketable securities | 982,317 | 984,994 | ||||||||
| Trade accounts receivable, net | 440,699 | 421,752 | ||||||||
| Inventories | 144,859 | 102,602 | ||||||||
| Deferred tax assets, current | 50,281 | 41,432 | ||||||||
| Other current assets | 111,105 | 106,220 | ||||||||
| Property, plant and equipment, net | 273,326 | 201,109 | ||||||||
| Intangible assets, net | 599,786 | 609,719 | ||||||||
| Goodwill | 254,073 | 254,073 | ||||||||
| Deferred tax assets, noncurrent | 7,417 | 3,394 | ||||||||
| Other noncurrent assets | 77,902 | 62,544 | ||||||||
| Total assets | $ | 3,553,810 | $ | 3,317,696 | ||||||
| Accounts payable and accrued expenses | $ | 240,809 | $ | 423,940 | ||||||
| Current portion of long-term debt | 48,000 | 48,000 | ||||||||
| Other current liabilities | 128,892 | 110,489 | ||||||||
| Long-term debt, less current portion | 33,500 | 65,000 | ||||||||
| Contingent consideration, noncurrent | 108,232 | 106,744 | ||||||||
|
Deferred tax liabilities, noncurrent |
96 | 101,241 | ||||||||
| Other noncurrent liabilities | 112,699 | 80,203 | ||||||||
| Total liabilities | 672,228 | 935,617 | ||||||||
| Total stockholders' equity | 2,881,582 | 2,382,079 | ||||||||
| Total liabilities and stockholders' equity | $ | 3,553,810 | $ | 3,317,696 | ||||||
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