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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 |
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial results for the first quarter of 2017. Total revenues in the quarter were $870 million, a 24 percent increase compared to the same period in 2016. First quarter revenues included a benefit of $29 million from a change in revenue recognition in 2017 for certain non-U.S. markets; excluding the benefit of this accounting change, revenues increased to $841 million, a 20 percent increase compared to the same period in 2016. The negative impact of foreign currency on total revenue year-over-year was 2 percent or $12 million, net of hedging activities. On a GAAP basis, diluted earnings per share (EPS) in the quarter was $0.75 per share, compared to $0.41 per share in the first quarter of 2016. Non-GAAP diluted EPS for the first quarter of 2017 was $1.38 per share. Non-GAAP diluted EPS was $0.99 per share in the first quarter of 2016, including a reduction of $0.12 per share to conform to the current non-GAAP income tax expense definition.
"We delivered continued double-digit revenue growth in the quarter from our complement and metabolic portfolios and achieved important regulatory milestones towards the potential approval of Soliris as a treatment for patients with refractory gMG in the U.S., Europe and Japan. We also demonstrated strong commercial execution for Soliris while simultaneously enrolling patients with PNH and aHUS into the ALXN1210 Phase 3 trials," said Ludwig Hantson, Chief Executive Officer of Alexion. "Alexion’s strong performance in the first quarter positions us well for continued success in 2017 and beyond. As we continue to grow our business, we will be anchored by a culture of compliance and driven by passion and dedication to patients. I am excited to work with our team to capitalize on Alexion’s fundamentals to drive continued momentum and long-term growth by enhancing our commercial, R&D and capital allocation priorities to drive superior financial performance and shareholder returns."
First Quarter 2017 Financial Highlights
Product and Pipeline Updates
Complement Portfolio
Metabolic Portfolio
Immuno-Oncology Program
2017 Financial Guidance
Alexion is reiterating its 2017 revenue and operating margin guidance provided on the fourth quarter and full year 2016 earnings call and increasing its GAAP and non-GAAP EPS guidance.
Updated GAAP Updated Non-GAAP Prior Non-GAAP Guidance Prior GAAP Guidance Guidance Guidance Total revenues $3,400 to $3,500 million $3,400 to $3,500 million $3,400 to $3,500 million $3,400 to $3,500 million Soliris revenues $3,025 to $3,100 million $3,025 to $3,100 million $3,025 to $3,100 million $3,025 to $3,100 million Metabolic revenues $375 to $400 million $375 to $400 million $375 to $400 million $375 to $400 million R&D (% total revenues) 24% to 26% 24% to 27% 22% to 23% 22% to 23% SG&A (% total revenues) 28% to 30% 29% to 30% 25% to 26% 25% to 26% Operating margin 25% to 28% 25% to 28% 43% to 44% 43% to 44% Earnings per share $2.80 to $3.20 $2.55 to $3.05 $5.10 to $5.30 $5.00 to $5.25Alexion’s 2017 financial guidance is based on current foreign exchange rates net of hedging activities and does not include the effect of business combinations, license and collaboration agreements, asset acquisitions, intangible asset impairments, changes in fair value of contingent consideration or restructuring activity that may occur after the day prior to the date of this press release.
Conference Call/Webcast Information:
Alexion will host a conference call/audio webcast to discuss the first quarter 2017 results, at 10:00 a.m. Eastern Time. To participate in the call, dial 888-329-8877 (USA) or 719-457-2648 (International), passcode 6536169 shortly before 10:00 a.m. Eastern Time. A replay of the call will be available for a limited period following the call. The replay number is 888-203-1112 (USA) or 719-457-0820 (International), passcode 6536169. The audio webcast can be accessed on the Investor page of Alexion’s website at: http://ir.alexionpharm.com.
About Alexion
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion is the global leader in complement inhibition and has developed and commercializes 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. In addition, Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Alexion is advancing its rare disease pipeline with highly innovative product candidates in multiple therapeutic areas. This press release and further information about Alexion can be found at: www.alexion.com.
[ALXN-E]
This press release contains forward-looking statements, including statements related to guidance regarding anticipated financial results for 2017, assessment of the Company's commercialization efforts and commercial potential for Soliris, Strensiq and Kanuma, medical and commercial potential of each of Alexion's product candidates, launch expectations for Strensiq and Kanuma, and plans for regulatory filings and clinical programs for 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 the adequacy of our research, 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, failure to satisfactorily address matters raised by the FDA and other regulatory agencies, the possibility that results of clinical trials are not predictive of safety and efficacy results of our products in broader patient populations, the possibility that current rates of adoption of Soliris in PNH, aHUS or other diseases are not sustained, the possibility that clinical trials of our product candidates could be delayed, 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, including investigations of Alexion by the U.S. Securities and Exchange Commission (SEC) and U.S. Department of Justice, the risk that anticipated regulatory filings are delayed, the risk that estimates regarding the number of patients with PNH, aHUS, HPP and LAL-D are inaccurate, the risks of changing foreign exchange rates, and a variety of other risks set forth from time to time in Alexion's filings with the SEC, including but not limited to the risks discussed in Alexion's Annual Report on Form 10-K for the period ended December 31, 2016 and in our other filings with the SEC. 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 press 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, fair value adjustment of inventory acquired, amortization of purchased intangible assets, changes in fair value of contingent consideration, acquisition-related costs, restructuring expenses, upfront and milestone payments related to licenses and collaborations, impairment of intangible assets and adjustments to income tax expense. 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 Reconciliations of GAAP to non-GAAP Financial Results and GAAP to non-GAAP 2017 Financial Guidance 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 March 31, 2017 and 2016 and projected twelve months ended December 31, 2017.
(Tables Follow)
ALEXION PHARMACEUTICALS, INC. TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in millions, except per share amounts) (unaudited) Three months ended March 31 2017 2016 Net product sales $ 869 $ 700 Other revenue 1 1 Total revenues 870 701 Cost of sales 69 59 Operating expenses: Research and development 219 176 Selling, general and administrative 262 233 Amortization of purchased intangible assets 80 80 Change in fair value of contingent consideration 4 (15 ) Acquisition-related costs — 1 Restructuring expenses 24 1 Total operating expenses 589 476 Operating income 212 166 Other income and expense: Investment income 4 1 Interest expense (24 ) (24 ) Other income 2 — Income before income taxes 194 143 Income tax expense 24 51 Net income $ 170 $ 92 Earnings per common share Basic $ 0.76 $ 0.41 Diluted $ 0.75 $ 0.41 Shares used in computing earnings per common share Basic 224 225 Diluted 226 227 ALEXION PHARMACEUTICALS, INC. TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (in millions, except per share amounts) (unaudited) Three months ended March 31 2017 2016 GAAP net income $ 170 $ 92 Before tax adjustments: Cost of sales: Share-based compensation 2 3 Fair value adjustment in inventory acquired (1) 2 1 Research and development expense: Share-based compensation 16 15 Upfront and milestone payments related to licenses and collaborations 9 3 Selling, general and administrative expense: Share-based compensation 36 38 Amortization of purchased intangible assets 80 80 Change in fair value of contingent consideration 4 (15 ) Acquisition-related costs — 1 Restructuring expenses (2) 24 1 Adjustments to income tax expense (3) (4) (27 ) 8 Non-GAAP net income $ 316 $ 227 GAAP earnings per common share - diluted $ 0.75 $ 0.41 Non-GAAP earnings per common share - diluted (4) $ 1.38 $ 0.99 Shares used in computing diluted earnings per common share (GAAP) 226 227 Shares used in computing diluted earnings per common share (non-GAAP) 229 229 (1) Inventory fair value adjustment associated with the amortization of Kanuma inventory step-up related to the purchase accounting for Synageva. (2) Restructuring expenses of $24 million are related to the company-wide restructuring initiated in the first quarter 2017. (3) Alexion's non-GAAP income tax expense definition excludes the tax effect of pre-tax adjustments to GAAP net income and intercompany transactions with our captive foreign partnership which would become due and payable only upon liquidation of a substantial portion of our non-US business interests. (4) Previously reported non-GAAP tax expense and diluted EPS have been modified to conform to the current non-GAAP income tax expense definition adopted in Q2 2016. Previously reported non-GAAP EPS was $1.11 for the three months ended March 31, 2016. ALEXION PHARMACEUTICALS, INC. TABLE 3: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL GUIDANCE (in millions, except per share amounts and percentages) (unaudited) Twelve months ended December 31, 2017 Low High GAAP net income $ 635 $ 726 Before tax adjustments: Share-based compensation 230 197 Fair value adjustment in inventory acquired 5 5 Upfront and milestone payments related to licenses and collaborations 16 9 Amortization of purchased intangible assets 320 320 Change in fair value of contingent consideration 14 14 Restructuring expenses 34 24 Adjustments to income tax expense (86 ) (81 ) Non-GAAP net income $ 1,168 $ 1,214 Diluted GAAP earnings per share $ 2.80 $ 3.20 Diluted Non-GAAP earnings per share $ 5.10 $ 5.30 Operating expense and margin (% total revenues) GAAP research and development expense 26 % 24 % Share-based compensation (2 )% (2 )% Upfront and milestone payments related to licenses and collaborations (1 )% 0 % Non-GAAP research and development expense 23 % 22 % GAAP selling, general and administrative expense 30 % 28 % Share-based compensation (4 )% (3 )% Non-GAAP selling, general and administrative expense 26 % 25 % GAAP operating margin 25 % 28 % Share-based compensation 7 % 6 % Fair value adjustment in inventory acquired 0 % 0 % Upfront and milestone payments related to licenses and collaborations 1 % 0 % Amortization of purchased intangible assets 9 % 9 % Change in fair value of contingent consideration 0 % 0 % Restructuring expenses 1 % 1 % Non-GAAP operating margin 43 % 44 % ALEXION PHARMACEUTICALS, INC. TABLE 4: NET PRODUCT SALES (in millions) (unaudited) Three months ended March 31 2017 2016 Soliris $ 783 $ 665 Strensiq 74 33 Kanuma 12 2 Total net product sales $ 869 $ 700 ALEXION PHARMACEUTICALS, INC. TABLE 5: NET PRODUCT SALES BY GEOGRAPHY (in millions) (unaudited) Three months ended March 31 2017 2016 United States $ 360 $ 265 Europe 248 227 Asia-Pacific 83 72 Rest of World 178 136 Total net product sales $ 869 $ 700 ALEXION PHARMACEUTICALS, INC. TABLE 6: CONDENSED CONSOLIDATED BALANCE SHEETS (in millions) (unaudited) March 31 December 31 2017 2016 Cash and cash equivalents $ 713 $ 966 Marketable securities 749 327 Trade accounts receivable, net 660 650 Inventories 396 375 Prepaid expenses and other current assets (1) 215 260 Property, plant and equipment, net 1,138 1,036 Intangible assets, net 4,223 4,303 Goodwill 5,037 5,037 Other assets 304 299 Total assets $ 13,435 $ 13,253 Accounts payable and accrued expenses $ 607 $ 572 Deferred revenue 16 37 Current portion of long-term debt 167 167 Current portion of contingent consideration 25 24 Other current liabilities 22 23 Long-term debt, less current portion 2,846 2,888 Contingent consideration 132 129 Facility lease obligation 270 233 Deferred tax liabilities 384 396 Other liabilities 110 90 Total liabilities 4,579 4,559 Total stockholders' equity (1) 8,856 8,694 Total liabilities and stockholders' equity $ 13,435 $ 13,253 (1) In October 2016, the FASB issued a new income tax standard that eliminates the exception for an intra-entity asset transfer other than inventory. We elected to early adopt this standard in the first quarter 2017. As a result of the adoption, we recorded a $19 million decrease in retained earnings, primarily resulting from the elimination of previously recorded prepaid tax assets.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170427005442/en/
Alexion Contacts:MediaStephanie Fagan, 475-230-3777Senior Vice President, Corporate CommunicationsorKim Diamond, 475-230-3775Executive Director, Corporate CommunicationsorInvestorsElena Ridloff, CFA, 475-230-3601Vice President, Investor RelationsorCatherine Hu, 475-230-3599Director, Investor Relations
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