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Share Name | Share Symbol | Market | Type |
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Alexion Pharmaceuticals Inc | NASDAQ:ALXN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 182.50 | 183.00 | 185.00 | 0 | 01:00:00 |
– Soliris® (eculizumab) Net Product Sales of $636 Million; Increased 24% Year-on-Year Despite Currency Headwinds; 31% Volume Increase Year-on-Year –
– 2015 Revenue Guidance Increased Reflecting Strong Growth of Soliris in PNH and aHUS –
– Positive CHMP Opinions Received for Strensiq™ (asfotase alfa) for Hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) for Lysosomal Acid Lipase Deficiency (LAL-D) in the European Union –
– Strensiq Approved in Japan; Kanuma NDA Filed in Japan –
– Exceeded Target Enrollment in Eculizumab Refractory Myasthenia Gravis Registration Trial –
– Completed Synageva Acquisition –
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the second quarter of 2015. Net product sales of Soliris® (eculizumab) grew to $636 million, a 24% increase, compared to $512.5 million for the same period in 2014, despite currency headwinds. Non-GAAP diluted earnings per share (EPS) for the second quarter of 2015 were $1.44, compared to $1.12 in the second quarter of 2014. On a GAAP basis, diluted EPS for the second quarter of 2015 was $0.83 per share, impacted by $40.1 million, or $0.20 per share, related to acquisition and restructuring costs resulting from the Synageva acquisition, compared to $0.83 in the second quarter of 2014.
“In the second quarter of 2015, we achieved many significant commercial, development and financial milestones while also closing the Synageva acquisition to strengthen our position as the global leader in serving patients with devastating and rare diseases,” said David Hallal, Chief Executive Officer of Alexion. “In the second half of 2015, we will continue to serve more patients with PNH and aHUS, while simultaneously launching Strensiq and Kanuma globally, and advancing our broad pipeline of innovative therapies to support our future growth.”
Second Quarter 2015 Financial Highlights
Product and Pipeline Updates
Complement Portfolio
Metabolic Portfolio
Preclinical Portfolio
2015 Financial Guidance
Alexion today announced that the Company is revising upward its revenue guidance for 2015 from the previous range of $2.55 to $2.6 billion, now to the higher and narrower range of $2.6 to $2.62 billion, which includes an approximately negative 6 percent, or $160 million, foreign exchange impact compared to 2014 exchange rates.
Alexion is reducing its 2015 non-GAAP tax rate guidance to the lower range of 3 percent to 4 percent, from the previous range of 7 percent to 9 percent. Alexion is also reducing its longer-term non-GAAP tax rate guidance to the lower range of 12 percent to 14 percent in 2019 and beyond, from the previous range of 14 percent to 16 percent, a reduction of 2 percent.
Alexion is also revising 2015 non-GAAP financial guidance as follows, which reflects the inclusion of Synageva financial results into Alexion’s consolidated results beginning June 22, 2015, the acquisition closing date:
Cost of sales 8% to 9% of net product sales Research and development expense $520 to $540 million Selling, general and administrative expense $690 to $710 million Interest expense$55 million
Effective tax rate 3% to 4 % Diluted shares outstanding 219 millionAs a result of these changes, Alexion is revising 2015 non-GAAP EPS guidance to the range of $4.70 to $4.80 per share, from the previous range of $5.60 to $5.80 per share.
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, July 30, at 10:00 a.m., Eastern Time. To participate in this call, dial 1-888-500-6973 (USA) or + 719-457-2643 (International), passcode 3227303 shortly before 10:00 a.m., Eastern Time. A replay of the call will be available for a limited period following the call, beginning at 1:00 p.m., Eastern Time. The replay number is 1-888-203-1112 (USA) or +1-719-457-0820 (International), passcode 3227303. The audio webcast and slide presentation can be accessed on the Investor page of Alexion’s website at: http://ir.alexionpharm.com.
About Soliris® (eculizumab)
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), European Union (2007), Japan (2010) and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. PNH is a debilitating, ultra-rare and life-threatening blood disorder, characterized by complement-mediated hemolysis (destruction of red blood cells). Soliris is also approved in the U.S. (2011), European Union (2011), Japan (2013) and other countries as the first and only treatment for patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, or TMA (blood clots in small vessels). aHUS is a debilitating, ultra-rare and life-threatening genetic disorder characterized by complement-mediated TMA. Soliris is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). For the breakthrough medical innovation in complement inhibition, Alexion and Soliris have received some of the pharmaceutical industry's highest honors: the Prix Galien USA (2008, Best Biotechnology Product) and France (2009, Rare Disease Treatment).
More information including the full U.S. prescribing information on Soliris is available at www.soliris.net.
About Strensiq™ (asfotase alfa)
Strensiq™ (asfotase alfa) is an investigational first-in-class bone-targeted enzyme replacement therapy designed to address the underlying cause of hypophosphatasia (HPP)—deficient alkaline phosphatase (ALP). By replacing deficient ALP, treatment with Strensiq aims to improve the elevated enzyme substrate levels and improve the body's ability to mineralize bone, thereby preventing serious skeletal and systemic patient morbidity and premature death.
The FDA granted Breakthrough Therapy designation for Strensiq and accepted Alexion’s Biologics License Application (BLA) for Priority Review. Alexion has also submitted a Marketing Authorization Application (MAA) for Strensiq to the EMA. Strensiq is approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with HPP.
About Kanuma™ (sebelipase alfa)
Kanuma™ (sebelipase alfa) is an investigational first-in-class enzyme replacement therapy designed to address the underlying cause of lysosomal acid lipase deficiency (LAL-D). By replacing deficient LAL, treatment with Kanuma aims to reduce substrate accumulation and improve lipid metabolism to prevent chronic lipid accumulation, vital organ damage and premature death.
The FDA granted Breakthrough Therapy designation for Kanuma for LAL Deficiency presenting in infants. The FDA accepted the Kanuma BLA for Priority Review, and the EMA validated the MAA for Kanuma and is reviewing it under accelerated assessment. In addition, a New Drug Application for Kanuma has been submitted to Japan’s MHLW.
About Alexion
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. Alexion is also establishing a premier global metabolic rare disease franchise with the development of two late-stage therapies, Strensiq™ (asfotase alfa) for hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) for Lysosomal Acid Lipase Deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors across diverse platforms, including evaluating potential indications for Soliris in additional severe and ultra-rare disorders. This press release and further information about Alexion can be found at: www.alexion.com.
[ALXN-E]
This news release contains forward-looking statements, including statements related to guidance regarding anticipated financial results for 2015, assessment of the Company's financial position and commercialization efforts, medical benefits and commercial potential for Soliris, Strensiq and Kanuma, medical and commercial potential of Alexion's complement-inhibition technology and other technologies, commercial potential associated with the expected launches of Strensiq and Kanuma in 2015, 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 our products, delays, interruptions or failures in the manufacture and supply of our products and our product candidates, progress in establishing and developing commercial infrastructure, failure to satisfactorily address the issues raised by the FDA in regulatory correspondence, the possibility that results of clinical trials are not predictive of safety and efficacy results of our products in broader patient populations in the disease studied or other diseases, the risk that strategic transactions 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 possibility that clinical trials of our product candidates could be delayed or that additional research and testing is required by regulatory agencies, the adequacy of our pharmacovigilance and drug safety reporting processes, the risk that third party payors (including governmental agencies) will not reimburse or continue to reimburse for the use of our products at acceptable rates or at all, risks regarding government investigations, the risk that estimates regarding the number of patients with PNH, aHUS or other diseases are inaccurate, and a variety of other risks set forth from time to time in Alexion's filings with the U.S. Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended March 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission, including the Registration Statement on Form S-4 filed on May 22, 2015. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.
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, upfront and milestone payments related to license and collaboration agreements, intangible asset impairments, restructuring expenses, 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 June 30, 2015 and 2014.
(Tables Follow)
ALEXION PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (unaudited) Three months ended Six months ended June 30 June 30 2015 2014 2015 2014 Net product sales $ 635,983 $ 512,495 $ 1,236,316 $ 1,079,111 Other revenue 227 - 227 - Total revenues 636,210 512,495 1,236,543 1,079,111 Cost of sales 52,007 39,626 121,406 72,565 Operating expenses: Research and development 131,693 92,554 352,773 284,011 Selling, general and administrative 221,383 159,477 408,499 288,768 Impairment of intangible asset - - - 3,464 Acquisition-related costs 33,821 1,989 45,800 1,951 Restructuring expenses 16,224 - 23,276 - Total operating expenses 403,121 254,020 830,348 578,194 Operating income 181,082 218,849 284,789 428,352 Other income (expense) (3,790 ) (203 ) (552 ) 2,205 Income before income taxes 177,292 218,646 284,237 430,557 Income tax provision 7,077 52,151 22,699 104,708 Net income $ 170,215 $ 166,495 $ 261,538 $ 325,849 Earnings per common share Basic $ 0.84 $ 0.84 $ 1.30 $ 1.65 Diluted $ 0.83 $ 0.83 $ 1.29 $ 1.62 Shares used in computing earnings per common share Basic 202,234 197,880 200,806 197,838 Diluted 204,546 201,524 203,302 201,715 ALEXION PHARMACEUTICALS, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (in thousands, except per share amounts) (unaudited) Three months ended Six months ended June 30 June 30 2015 2014 2015 2014 Net income reconciliation: GAAP net income $ 170,215 $ 166,495 $ 261,538 $ 325,849 Share-based compensation expense 67,000 28,414 109,797 52,254 Acquisition-related costs (1) 33,821 1,989 48,778 1,951 Upfront and milestone payments related to license and collaboration agreements 1,750 - 114,250 101,925 Impairment of intangible assets - - - 3,464Restructuring expenses (2)
16,224 - 23,276 -Non-cash taxes (3)
8,722 32,174 5,050 56,228 Non-GAAP net income $ 297,732 $ 229,072 $ 562,689 $ 541,671 GAAP earnings per share - diluted $ 0.83 $ 0.83 $ 1.29 $ 1.62 Non-GAAP earnings per share - diluted $ 1.44 $ 1.12 $ 2.72 $ 2.65 Shares used in computing diluted earnings per share (GAAP) 204,546 201,524 203,302 201,715 Shares used in computing diluted earnings per share (non-GAAP) 206,934 204,435 205,488 204,631 Cost of sales reconciliation: GAAP cost of sales $ 52,007 $ 39,626 $ 121,406 $ 72,565 Share-based compensation expense (1,344 ) (964 ) (2,753 ) (1,847 ) Non-GAAP cost of sales $ 50,663 $ 38,662 $ 118,653 $ 70,718 Research and development expense reconciliation: GAAP research and development expense $ 131,693 $ 92,554 $ 352,773 $ 284,011 Share-based compensation expense (13,329 ) (7,453 ) (24,413 ) (15,437 ) Upfront and milestone payments related to license and collaboration agreements (1,750 ) - (114,250 ) (101,925 ) Non-GAAP research and development expense $ 116,614 $ 85,101 $ 214,110 $ 166,649 Selling, general and administrative expense reconciliation: GAAP selling, general and administrative expense $ 221,383 $ 159,477 $ 408,499 $ 288,768 Share-based compensation expense (52,327 ) (19,997 ) (82,631 ) (34,970 ) Non-GAAP selling, general and administrative expense $ 169,056 $ 139,480 $ 325,868 $ 253,798 Income tax provision reconciliation: GAAP income tax provision $ 7,077 $ 52,151 $ 22,699 $ 104,708Non-cash taxes (3)
(8,722 ) (32,174 ) (5,050 ) (56,228 ) Non-GAAP income tax provision (benefit) $ (1,645 ) $ 19,977 $ 17,649 $ 48,480(1) The following table summarizes acquisition-related costs:
Three months ended Six months ended June 30 June 30 2015 2014 2015 2014 Acquisition-related costs: Transaction costs $ 26,799 $ - $ 29,777 $ - Integration costs 2,978 - 2,978 - Changes in fair value of contingent consideration 4,044 1,989 16,023 1,951 $ 33,821 $ 1,989 $ 48,778 $ 1,951 (2)Restructuring expenses of $16.2 million were related to $10.3 million resulting from the Synageva acquisition and an additional $5.9 million related to the European headquarters relocation.
(3)Non-cash taxes represents the adjustment from GAAP tax expense to the amount of taxes that are payable (receivable) in cash in the current period. In the second quarter 2015, the Company completed the acquisition of Synageva which resulted in a benefit to both GAAP and non-GAAP taxes from the utilization of Synageva's operating losses in 2015. The tax benefit recorded in the second quarter is resulting from the application of the lower full year tax rate to the first half of the year.
ALEXION PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) June 30, December 31, 2015 2014 Cash and cash equivalents $ 1,322,123 $ 943,999 Marketable securities 172,229 1,017,567 Trade accounts receivable, net 535,824 432,888 Inventories 234,347 176,441 Prepaid expenses and other current assets 268,715 225,134 Property, plant and equipment, net 555,388 392,248 Intangible assets, net 4,824,520 587,046 Goodwill 5,007,142 254,073 Other assets 247,431 172,566 Total assets $ 13,167,719 $ 4,201,962 Accounts payable and accrued expenses $ 454,384 $ 439,248 Deferred revenue 88,366 58,837 Current portion of long-term debt 131,250 48,000Deferred tax liabilities, current
42,018 12,476 Other current liabilities 53,151 48,179 Long-term debt, less current portion 3,368,750 9,500 Facility lease obligation 129,560 107,099 Contingent consideration 129,546 116,425 Other liabilities 217,823 60,180 Total liabilities 4,614,848 899,944 Total stockholders' equity 8,552,871 3,302,018 Total liabilities and stockholders' equity $ 13,167,719 $ 4,201,962
View source version on businesswire.com: http://www.businesswire.com/news/home/20150730005382/en/
Alexion:MediaStephanie Fagan, 203-271-8223Senior Vice President, Corporate CommunicationsorKim Diamond, 203-439-9600Executive Director, Corporate CommunicationsorInvestorsElena Ridloff, CFA, 203-699-7722Executive Director, Investor Relations
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