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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 fourth quarter and full year of 2016. Total revenues for the full year of 2016 were $3.084 billion, an 18 percent increase compared to 2015. The negative impact of foreign currency on total revenue year over year was 3 percent or $74 million, net of hedging activities. On a GAAP basis, diluted earnings per share (EPS) for the full year of 2016 was $1.76 per share, compared to $0.67 per share in 2015. Non-GAAP diluted EPS for the full year of 2016 was $4.62 per share. Non-GAAP diluted EPS was $4.65 per share for the full year of 2015, reflecting a reduction of $0.34 per share to conform to the current non-GAAP income tax expense definition.
Total revenues in the fourth quarter grew to $831 million, a 19 percent increase compared to the same period in 2015. The negative impact of foreign currency on total revenue in the fourth quarter was 2 percent or $12 million, net of hedging activities. On a GAAP basis, diluted EPS for the fourth quarter of 2016 was $0.41 per share, compared to $0.29 per share in the fourth quarter of 2015. Non-GAAP diluted EPS for the fourth quarter of 2016 was $1.26 per share. Non-GAAP diluted EPS was $1.04 per share in the fourth quarter of 2015, reflecting a reduction of $0.09 per share to conform to the current non-GAAP income tax expense definition. Both GAAP and non-GAAP results are inclusive of legal, accounting, and other costs associated with the Audit and Finance Committee's completed investigation.
"In 2016 the global Alexion team delivered on our patient-centered objectives as we grew our leadership in complement by serving more patients with PNH and aHUS, and continued to build our metabolic franchise with the global launches of Strensiq and Kanuma. We also achieved important regulatory milestones towards new indications for Soliris and initiated two registration studies for ALXN1210 to drive our future growth," said David Brennan, Interim Chief Executive Officer of Alexion. "Our 2017 guidance reflects double-digit revenue and EPS growth as we continue to grow our complement and metabolic franchises, prepare for the potential launches of Soliris in refractory gMG, and focus on our highest priority R&D programs."
Full Year 2016 Financial Highlights
Fourth Quarter 2016 Financial Highlights
Share Repurchase Authorization
The Company also announced that its Board of Directors has increased the size of the Company's share repurchase authorization to a total of $1 billion. The Board’s authorization is open-ended.
Product and Pipeline Updates
Complement Portfolio
Metabolic Portfolio
Immuno-Oncology Program
2017 Financial Guidance
GAAP Guidance Non-GAAP Guidance Total revenues $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 Metabolic revenues $375 to $400 million $375 to $400 million Research and development expense (% total revenues) 24% to 27% 22% to 23% Selling, general and administrative expense (% total revenues) 29% to 30% 25% to 26%Operating margin
25% to 28% 43% to 44% Earnings per share $2.55 to $3.05 $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 fourth quarter and full year 2016 results, at 10:00 a.m. Eastern Time. To participate in the call, dial 877-681-3372 (USA) or 719-325-4794 (International), passcode 5877612 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 5877612. 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 SEC and DOJ, 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 shifting foreign exchange rates, 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 September 30, 2016 and in our other filings with the U.S. Securities and Exchange Commission. 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 2016 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 and twelve month periods ended December 31, 2016 and 2015 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 Twelve months ended December 31 December 31 2016 2015 2016 2015 Net product sales $ 831 $ 701 $ 3,082 $ 2,603 Other revenue - - 2 1 Total revenues 831 701 3,084 2,604 Cost of sales 68 58 258 233 Operating expenses: Research and development 206 191 757 709 Selling, general and administrative 259 242 954 863 Amortization of purchased intangible assets 80 80 322 117 Change in fair value of contingent consideration 5 19 36 64 Acquisition-related costs - 3 2 39 Restructuring expenses 1 11 3 42 Impairment of intangible assets 85 - 85 - Total operating expenses 636 546 2,159 1,834 Operating income 127 97 667 537 Other income and expense: Investment income 3 1 11 8 Interest expense (25 ) (23 ) (97 ) (48 ) Foreign currency (loss) gain (1 ) (1 ) (5 ) 1 Income before income taxes 104 74 576 498 Income tax expense 11 7 177 354 Net income $ 93 $ 67 $ 399 $ 144 Earnings per common share Basic $ 0.41 $ 0.30 $ 1.78 $ 0.68 Diluted $ 0.41 $ 0.29 $ 1.76 $ 0.67 Shares used in computing earnings per common share Basic 225 225 224 213 Diluted 226 228 227 216 ALEXION PHARMACEUTICALS, INC. TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (in millions, except per share amounts) (unaudited) Three months ended Twelve months ended December 31 December 31 2016 2015 2016 2015 GAAP net income $ 93 $ 67 $ 399 $ 144 Before tax adjustments: Cost of sales: Share-based compensation 3 3 11 7 Fair value adjustment of inventory acquired (1) 2 - 11 - Research and development expense: Share-based compensation 14 21 57 64 Upfront and milestone payments related to license and collaboration agreements 6 15 10 130 Selling, general and administrative expense: Share-based compensation 25 44 124 156 Amortization of purchased intangible assets (2) 80 80 322 117 Change in fair value of contingent consideration 5 18 36 64 Acquisition-related costs (3) - 3 2 39 Restructuring expenses 1 12 3 42 Impairment of intangible assets (4) 85 - 85 - Adjustments to income tax expense (5) (6) (27 ) (23 ) (6 ) 251 Non-GAAP net income $ 287 $ 240 $ 1,054 $ 1,014 GAAP earnings per share - diluted $ 0.41 $ 0.29 $ 1.76 $ 0.67 Non-GAAP earnings per share - diluted (6) $ 1.26 $ 1.04 $ 4.62 $ 4.65 Shares used in computing diluted earnings per share (GAAP) 226 228 227 216 Shares used in computing diluted earnings per share (non-GAAP) 228 230 228 218 (1) Inventory fair value adjustment associated with the amortization of Kanuma inventory step-up related to the purchase accounting for Synageva. (2) In the third quarter of 2015, the Company initiated amortization of its purchased intangible assets due to the regulatory approvals for Strensiq and Kanuma. (3) The following table summarizes acquisition-related costs: Three months ended Twelve months ended December 31 December 31 2016 2015 2016 2015 Acquisition-related costs: Transaction costs $ - $ - $ - $ 27 Integration costs - 3 2 12 $ - $ 3 $ 2 $ 39 (4) During the fourth quarter of 2016, the Company recognized an impairment charge related to SBC-103, an early stage, clinical indefinite-lived intangible asset related to the Synageva acquisition. (5) 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. (6) Previously reported non-GAAP tax expense and diluted EPS have been modified to conform to the current non-GAAP income tax definition adopted in Q2 2016. Previously reported non-GAAP EPS was $1.13 and $4.99 for the three and twelve months ended December 31, 2015, respectively. 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 $ 578 $ 692 Before tax adjustments: Share-based compensation 231 207 Fair value adjustment in inventory acquired 5 5 Upfront and milestone payments related to licenses and collaborations 51 — Amortization of purchased intangible assets 320 320 Change in fair value of contingent consideration 14 14 Adjustments to income tax expense (54 ) (36 ) Non-GAAP net income $ 1,145 $ 1,202 Diluted GAAP earnings per share $ 2.55 $ 3.05 Diluted Non-GAAP earnings per share $ 5.00 $ 5.25 Operating expense and margin (% total revenues) GAAP research and development expense 27 % 24 % Share-based compensation (3 )% (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 % 29 % Share-based compensation (4 )% (4 )% 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 2 % 0 % Amortization of purchased intangible assets 9 % 9 % Change in fair value of contingent consideration 0 % 1 % Non-GAAP operating margin 43 % 44 % ALEXION PHARMACEUTICALS, INC. TABLE 4: NET PRODUCT SALES (in millions) (unaudited) Three months ended Twelve months ended December 31 December 31 2016 2015 2016 2015 Soliris $ 749 $ 689 $ 2,843 $ 2,591 Strensiq 71 12 210 12 Kanuma 11 — 29 — Total net product sales $ 831 $ 701 $ 3,082 $ 2,603 ALEXION PHARMACEUTICALS, INC. TABLE 5: NET PRODUCT SALES BY GEOGRAPHY (in millions) (unaudited) Three months ended Twelve months ended December 31 December 31 2016 2015 2016 2015 United States $ 354 $ 273 $ 1,257 $ 951 Europe 244 222 961 841 Asia-Pacific 85 73 318 276 Rest of World 148 133 546 535 Total net product sales $ 831 $ 701 $ 3,082 $ 2,603 ALEXION PHARMACEUTICALS, INC. TABLE 6: CONDENSED CONSOLIDATED BALANCE SHEETS (in millions) (unaudited) December 31 December 31 2016 2015 Cash and cash equivalents $ 966 $ 1,010 Marketable securities 327 375 Trade accounts receivable, net 650 533 Inventories 375 290 Prepaid expenses and other current assets 260 208 Property, plant and equipment, net 1,036 697 Intangible assets, net 4,303 4,708 Goodwill 5,037 5,048 Other assets 299 228 Total assets $ 13,253 $ 13,097 Accounts payable and accrued expenses $ 572 $ 460 Deferred revenue 37 21 Current portion of long-term debt 167 166 Other current liabilities 23 6 Current portion of contingent consideration 24 56 Long-term debt, less current portion 2,888 3,254 Facility lease obligation 233 151 Contingent consideration 129 121 Deferred tax liabilities (1) 396 529 Other liabilities 90 74 Total liabilities 4,559 4,838 Total stockholders' equity (1) 8,694 8,259 Total liabilities and stockholders' equity $ 13,253 $ 13,097 (1) In March 2016, the FASB issued a new standard intended to simplify certain aspects of the accounting for employee share-based payments. We elected to early adopt this standard during the third quarter of 2016. The adoption of the new standard requires recognition of excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. As a result, $238 million associated with previously unrecognized excess tax benefits was recorded as a deferred tax asset and an increase in retained earnings as of the beginning of 2016.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170216005317/en/
AlexionMediaStephanie Fagan, 475-230-3777Senior Vice President, Corporate CommunicationsorKim Diamond, 475-230-3775Executive Director, Corporate CommunicationsorInvestorsElena Ridloff, CFA, 475-230-3601Vice President, Investor Relations
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