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Share Name | Share Symbol | Market | Type |
---|---|---|---|
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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 182.50 | 183.00 | 185.00 | 0 | 01:00:00 |
Delaware | 000-27756 | 13-3648318 |
------------------ | ------------------ | --------------- |
(State or other jurisdiction of of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): | |
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Date: February 3, 2016 | ALEXION PHARMACEUTICALS, INC. |
By: /s/ Michael V. Greco | |
Name: Michael V. Greco | |
Title: Senior Vice President of Law and Corporate Secretary | |
• | Soliris® (eculizumab) net product sales were $2.590 billion compared to $2.146 billion in 2014, excluding the impact of $88 million in 2014 for reimbursement of shipments in prior years. |
• | Strensiq® (asfotase alfa) net product sales were $12 million. |
• | Non-GAAP R&D expense was $516 million compared to $368 million for 2014. GAAP R&D expense was $709 million compared to $514 million for 2014. |
• | Non-GAAP SG&A expense was $706 million compared to $556 million in 2014. GAAP SG&A expense was $863 million compared to $630 million in 2014. |
• | Non-GAAP diluted EPS was $4.99, compared to $5.21 in 2014. Full year 2014 non-GAAP EPS included $0.37 per share related to reimbursement of prior year shipments. On a GAAP basis, diluted EPS was $0.67 per share compared to $3.26 in 2014. Full year 2014 GAAP EPS included $0.31 per share related to reimbursement of prior year shipments. |
• | As of December 31, 2015, Alexion held cash, cash equivalents and marketable securities of $1.385 billion. |
• | Soliris net product sales were $689 million compared to $600 million in the same quarter last year, despite continued currency headwinds as well as macroeconomic factors in Latin American countries. |
• | Strensiq net product sales were $11.6 million. |
• | Non-GAAP R&D expense was $155 million compared to $108 million in the same quarter last year. GAAP R&D expense was $191 million compared to $129 million in the same quarter last year. |
• | Non-GAAP SG&A expense was $198 million compared to $164 million in the same quarter last year. GAAP SG&A expense was $242 million compared to $184 million in the same quarter last year. |
• | Non-GAAP diluted EPS was $1.13, compared to $1.30 in the same quarter last year. On a GAAP basis, diluted EPS was $0.29 per share compared to $0.76 in the same quarter last year. |
• | Q4 2014 non-GAAP EPS increased 49 percent to $1.30 per share, compared to Q4 2013 non-GAAP EPS of $0.87 per share. |
• | Eculizumab- Myasthenia Gravis (MG): Enrollment is complete in the REGAIN study, a single, multinational, placebo-controlled, registration trial of eculizumab in refractory MG, and preliminary data are expected in mid-2016. |
• | Eculizumab- Neuromyelitis Optica Spectrum Disorder (NMOSD): Alexion expects to complete enrollment in the PREVENT study, a single, multinational, placebo-controlled, registration trial of eculizumab in relapsing NMOSD, in 2016. |
• | Eculizumab- Delayed Graft Function (DGF): Enrollment is complete in the PROTECT study, a single, multinational DGF prevention registration trial with eculizumab, and preliminary data are expected in the second half of 2016. |
• | ALXN1210: Alexion has completed enrollment in a Phase 1/2 clinical study of ALXN1210, its highly innovative longer-acting C5 antibody, in patients with paroxysmal nocturnal hemoglobinuria (PNH) and is enrolling patients in a Phase 2 PNH study. In the fourth quarter, Alexion reported data showing a rapid reduction of LDH in initial patients with PNH receiving ALXN1210. Alexion expects to initiate a clinical program in patients with atypical hemolytic uremic syndrome (aHUS) in 2016. |
• | ALXN1007: Enrollment is ongoing in a Phase 2 proof-of-concept study of ALXN1007, a complement inhibitor that targets C5a, in patients with graft-versus-host disease involving the lower gastrointestinal tract (GI-GVHD). In the fourth quarter, Alexion reported interim Phase 2 data, showing an overall response rate at 28 days in patients with acute GI-GVHD. |
• | Strensiq: Strensiq was approved by the U.S. Food and Drug Administration (FDA) under Breakthrough Therapy Designation and Priority Review for the treatment of patients with perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP) in the fourth quarter of 2015. Alexion received a Rare Pediatric Disease Priority Review Voucher with the FDA approval. Strensiq was also approved in the European Union and Japan in the third quarter of 2015. |
• | Kanuma™ (sebelipase alfa): Kanuma was approved by the FDA under Breakthrough Therapy Designation and Priority Review for the treatment of patients of all ages with a diagnosis of lysosomal acid lipase deficiency (LAL-D) in the fourth quarter of 2015, and launched in the first quarter of 2016. Alexion received a Rare Pediatric Disease Priority Review Voucher with the FDA approval. Kanuma was also approved in the European Union in the third quarter of 2015. |
• | SBC-103: Alexion is enrolling patients in a Phase 1/2 trial of SBC-103, a recombinant form of the NAGLU enzyme, in patients with mucopolysaccharidosis IIIB, or MPS IIIB or Sanfilippo B. In the fourth quarter, Alexion reported interim data showing a dose-dependent reduction in heparan sulfate levels in cerebral spinal fluid at 12 weeks in patients with MPS-IIIB. Six-month data will be presented as a late-breaker abstract at the WORLDSymposium meeting in March. Alexion has also completed enrollment in a natural history study of patients with MPS IIIB. |
• | cPMP Replacement Therapy (ALXN 1101): Alexion has initiated a pivotal study to evaluate ALXN1101 in neonates with Molybdenum Cofactor Deficiency (MoCD) Type A. Alexion received Breakthrough Therapy designation for its cPMP replacement therapy. |
• | Alexion has more than 30 diverse preclinical programs across a range of therapeutic modalities, with four of these programs expected to enter the clinic in 2016. |
Constant Currency Guidance (1) | Foreign Exchange | Financial Guidance (2) | |||
Total product revenues | $3,170 to $3,220 million | ($120 million) | $3,050 to $3,100 million | ||
Soliris revenues | $2,900 to $2,925 million | ||||
Metabolic franchise revenues | $150 to $175 million | ||||
Cost of sales | 8% to 9% | ||||
Research and development | $650 to $680 million | ||||
Selling, general and administrative | $760 to $790 million | ||||
Interest expense | $100 million | ||||
Effective tax rate | 7% to 8% | ||||
Earnings per share | $5.31 to $5.51 | ($0.31) | $5.00 to $5.20 | ||
Diluted shares outstanding | 230 million |
ALEXION PHARMACEUTICALS, INC. | |||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||
(unaudited) | |||||||||||||||||
Three months ended | Twelve months ended | ||||||||||||||||
December 31 | December 31 | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Net product sales | $ | 700,425 | $ | 599,476 | $ | 2,602,532 | $ | 2,233,733 | |||||||||
Other revenues | 442 | — | 1,515 | ||||||||||||||
Total revenues | 700,867 | 599,476 | 2,604,047 | 2,233,733 | |||||||||||||
Cost of sales | 57,626 | 49,439 | 233,089 | 173,862 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 191,035 | 129,110 | 709,472 | 513,782 | |||||||||||||
Selling, general and administrative | 241,576 | 183,776 | 862,595 | 630,209 | |||||||||||||
Amortization of purchased intangible assets | 79,976 | — | 116,584 | — | |||||||||||||
Change in fair value of contingent consideration | 18,550 | 10,041 | 64,257 | 20,295 | |||||||||||||
Acquisition-related costs | 3,358 | — | 39,210 | — | |||||||||||||
Restructuring expenses | 11,432 | 15,365 | 42,169 | 15,365 | |||||||||||||
Impairment of intangible asset | — | 8,050 | — | 11,514 | |||||||||||||
Total operating expenses | 545,927 | 346,342 | 1,834,287 | 1,191,165 | |||||||||||||
Operating income | 97,314 | 203,695 | 536,671 | 868,706 | |||||||||||||
Other income and expense: | |||||||||||||||||
Investment income | 1,442 | 2,196 | 8,519 | 8,373 | |||||||||||||
Interest expense | (23,151 | ) | (549 | ) | (47,744 | ) | (2,982 | ) | |||||||||
Foreign currency gain (loss) | (1,059 | ) | (1 | ) | 696 | (1,990 | ) | ||||||||||
Income before income taxes | 74,546 | 205,341 | 498,142 | 872,107 | |||||||||||||
Income tax provision | 7,942 | 52,009 | 353,757 | 215,195 | |||||||||||||
Net income | $ | 66,604 | $ | 153,332 | $ | 144,385 | $ | 656,912 | |||||||||
Earnings per common share | |||||||||||||||||
Basic | $ | 0.30 | $ | 0.77 | $ | 0.68 | $ | 3.32 | |||||||||
Diluted | $ | 0.29 | $ | 0.76 | $ | 0.67 | $ | 3.26 | |||||||||
Shares used in computing earnings per common share | |||||||||||||||||
Basic | 225,472 | 198,676 | 213,431 | 198,103 | |||||||||||||
Diluted | 227,967 | 201,732 | 215,933 | 201,623 |
ALEXION PHARMACEUTICALS, INC. | |||||||||||||||||
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS | |||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||
(unaudited) | |||||||||||||||||
Three months ended | Twelve months ended | ||||||||||||||||
December 31 | December 31 | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Net income reconciliation: | |||||||||||||||||
GAAP net income | $ | 66,604 | $ | 153,332 | $ | 144,385 | $ | 656,912 | |||||||||
Share-based compensation expense | 66,280 | 33,840 | 227,133 | $ | 114,461 | ||||||||||||
Fair value adjustment of inventory acquired (1) | 91 | — | 91 | — | |||||||||||||
Amortization of purchased intangible assets (2) | 79,976 | — | 116,584 | — | |||||||||||||
Change in fair value of contingent consideration | 18,550 | 10,041 | 64,257 | 20,295 | |||||||||||||
Acquisition-related costs (3) | 3,358 | — | 39,210 | — | |||||||||||||
Restructuring expenses (4) | 11,432 | 15,365 | 42,169 | 15,365 | |||||||||||||
Impairment of intangible assets | — | 8,050 | — | 11,514 | |||||||||||||
Upfront and milestone payments related to license and collaboration agreements | 15,500 | 8,000 | 129,750 | 109,925 | |||||||||||||
Non-cash taxes (5) | (1,864 | ) | 37,355 | 324,978 | 137,449 | ||||||||||||
Non-GAAP net income | $ | 259,927 | $ | 265,983 | $ | 1,088,557 | $ | 1,065,921 | |||||||||
GAAP earnings per share - diluted | $ | 0.29 | $ | 0.76 | $ | 0.67 | $ | 3.26 | |||||||||
Non-GAAP earnings per share - diluted | $ | 1.13 | $ | 1.30 | $ | 4.99 | $ | 5.21 | |||||||||
Shares used in computing diluted earnings per share (GAAP) | 227,967 | 201,732 | 215,933 | 201,623 | |||||||||||||
Shares used in computing diluted earnings per share (non-GAAP) | 230,148 | 204,270 | 218,251 | 204,459 |
Three months ended | Twelve months ended | ||||||||||||||||
December 31 | December 31 | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Cost of sales reconciliation: | |||||||||||||||||
GAAP cost of sales | $ | 57,626 | $ | 49,439 | $ | 233,089 | $ | 173,862 | |||||||||
Share-based compensation expense | (2,407 | ) | (1,268 | ) | (6,630 | ) | (4,174 | ) | |||||||||
Fair value adjustment of inventory acquired (1) | (91 | ) | — | (91 | ) | — | |||||||||||
Non-GAAP cost of sales | $ | 55,128 | $ | 48,171 | $ | 226,368 | $ | 169,688 | |||||||||
Research and development expense reconciliation: | |||||||||||||||||
GAAP research and development expense | $ | 191,035 | $ | 129,110 | $ | 709,472 | $ | 513,782 | |||||||||
Share-based compensation expense | (20,735 | ) | (12,829 | ) | (64,235 | ) | (36,203 | ) | |||||||||
Upfront and milestone payments related to license and collaboration agreements | (15,500 | ) | (8,000 | ) | (129,750 | ) | (109,925 | ) | |||||||||
Non-GAAP research and development expense | $ | 154,800 | $ | 108,281 | $ | 515,487 | $ | 367,654 | |||||||||
Selling, general and administrative expense reconciliation: | |||||||||||||||||
GAAP selling, general and administrative expense | $ | 241,576 | $ | 183,776 | $ | 862,595 | $ | 630,209 | |||||||||
Share-based compensation expense | (43,138 | ) | (19,743 | ) | (156,268 | ) | (74,084 | ) | |||||||||
Non-GAAP selling, general and administrative expense | $ | 198,438 | $ | 164,033 | $ | 706,327 | $ | 556,125 | |||||||||
Income tax provision reconciliation: | |||||||||||||||||
GAAP income tax provision | $ | 7,942 | $ | 52,009 | $ | 353,757 | $ | 215,195 | |||||||||
Non-cash taxes (5) | 1,864 | (37,355 | ) | (324,978 | ) | (137,449 | ) | ||||||||||
Non-GAAP income tax provision | $ | 9,806 | $ | 14,654 | $ | 28,779 | $ | 77,746 | |||||||||
(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, 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 | |||||||||||||||||
Acquisition-related costs: | 2015 | 2014 | 2015 | 2014 | ||||||||||||||
Transaction costs | $ | 156 | $ | — | $ | 26,955 | $ | — | ||||||||||
Professional fees | 3,202 | — | 12,255 | — | ||||||||||||||
$ | 3,358 | $ | — | $ | 39,210 | $ | — | |||||||||||
(4 | ) | In the fourth quarter 2015, restructuring expenses includes $11.2 million related to exit costs associated with the US headquarters relocation to New Haven, CT. During the twelve months ended December 31, 2015 restructuring expenses of $42.2 million includes $17.6 million related to the European headquarters relocation, $13.4 million resulting from the acquisition of Synageva, and $11.2 million related to exit costs associated with the US headquarters relocation to New Haven, CT. | ||||||||||||||||
(5 | ) | Non-cash taxes represents the adjustment from GAAP tax expense to the amount of taxes that are payable in cash in the current period. In the third quarter 2015, the Company recorded a $315.6 million GAAP income tax expense resulting from a non-cash deferred income tax expense from the integration of Synageva. The deferred income tax expense resulted from the integration of Synageva assets into our captive partnership. | ||||||||||||||||
ALEXION PHARMACEUTICALS, INC. | ||||||||||||||||||
REVENUES | ||||||||||||||||||
(in thousands) | ||||||||||||||||||
(unaudited) | ||||||||||||||||||
Three months ended | Twelve months ended | |||||||||||||||||
December 31 | December 31 | |||||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||||
Soliris (1) | $ | 688,477 | $ | 599,476 | $ | 2,590,197 | $ | 2,233,733 | ||||||||||
Strensiq | 11,612 | — | 11,969 | — | ||||||||||||||
Kanuma | 336 | — | 366 | — | ||||||||||||||
Total net product revenues | 700,425 | 599,476 | 2,602,532 | 2,233,733 | ||||||||||||||
Royalty revenue | 442 | — | 1,515 | — | ||||||||||||||
Total other revenue | 442 | — | 1,515 | — | ||||||||||||||
Total revenues | $ | 700,867 | $ | 599,476 | $ | 2,604,047 | $ | 2,233,733 | ||||||||||
(1 | ) | Included within the Soliris revenues for the twelve months ended December 31, 2014 is a reimbursement of $88 million for shipments made in years prior to January 1, 2014 as a result of an agreement with the French government. |
ALEXION PHARMACEUTICALS, INC. | ||||||||||||||||||
NET PRODUCT REVENUES GEPGRAPHY | ||||||||||||||||||
(in thousands) | ||||||||||||||||||
(unaudited) | ||||||||||||||||||
Three months ended | Twelve months ended | |||||||||||||||||
December 31 | December 31 | |||||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||||
United States | $ | 272,725 | $ | 212,966 | $ | 951,307 | $ | 730,089 | ||||||||||
Europe (1) | 221,622 | 197,644 | 840,465 | 836,134 | ||||||||||||||
Asia-Pacific | 73,360 | 65,562 | 276,350 | 244,059 | ||||||||||||||
Other | 132,718 | 123,304 | 534,410 | 423,451 | ||||||||||||||
Total net product revenues | $ | 700,425 | $ | 599,476 | $ | 2,602,532 | $ | 2,233,733 | ||||||||||
(1 | ) | Included within the Soliris revenues for the twelve months ended December 31, 2014 is a reimbursement of $88 million for shipments made in years prior to January 1, 2014 as a result of an agreement with the French government. |
ALEXION PHARMACEUTICALS, INC. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(in thousands) | ||||||||
(unaudited) | ||||||||
December 31 | December 31 | |||||||
2015 | 2014 | |||||||
Cash and cash equivalents | $ | 1,010,111 | $ | 943,999 | ||||
Marketable securities | 374,904 | 1,017,567 | ||||||
Trade accounts receivable, net | 532,832 | 432,888 | ||||||
Inventories | 289,874 | 176,441 | ||||||
Prepaid expenses and other current assets | 217,628 | 225,134 | ||||||
Property, plant and equipment, net | 697,025 | 392,248 | ||||||
Intangible assets, net | 4,707,914 | 587,046 | ||||||
Goodwill | 5,047,885 | 254,073 | ||||||
Other assets | 255,057 | 172,566 | ||||||
Total assets | $ | 13,133,230 | $ | 4,201,962 | ||||
Accounts payable and accrued expenses | 460,708 | 439,248 | ||||||
Deferred revenue | 20,504 | 58,837 | ||||||
Current portion of long-term debt | 175,000 | 48,000 | ||||||
Other current liabilities | 62,038 | 60,655 | ||||||
Long-term debt, less current portion | 3,281,250 | 9,500 | ||||||
Contingent consideration | 121,424 | 116,425 | ||||||
Facility lease obligation | 151,307 | 107,099 | ||||||
Deferred tax liabilities | 528,990 | 7,046 | ||||||
Other liabilities | 73,393 | 53,134 | ||||||
Total liabilities | 4,874,614 | 899,944 | ||||||
Total stockholders' equity | 8,258,616 | 3,302,018 | ||||||
Total liabilities and stockholders' equity | $ | 13,133,230 | $ | 4,201,962 |
ALEXION PHARMACEUTICALS, INC. | |||||||||||||
NET PRODUCT SALES BY SIGNIFICANT GEOGRAPHIC REGION | |||||||||||||
(in thousands) | |||||||||||||
(unaudited) | |||||||||||||
Twelve months ended | |||||||||||||
December 31 | |||||||||||||
2014 | 2013 | % Variance | |||||||||||
United States | $ | 153,332 | $ | 561,405 | 30 | % | |||||||
Europe (1) | 836,134 | 514,987 | 62 | % | |||||||||
Asia Pacific | 244,059 | 203,538 | 20 | % | |||||||||
Other | 423,451 | 271,416 | 56 | % | |||||||||
Total net product sales | $ | 2,233,733 | $ | 1,551,346 | 44 | % | |||||||
(1 | ) | In March 2014, we entered into an agreement with the French government which positively impacted prospective reimbursement of Soliris and also provided for reimbursement for shipments made in years prior to January 1, 2014. As a result of the agreement, in the first quarter of 2014, we recognized $88 million of net product sales from Soliris in France relating to years prior to January 1, 2014. |
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