- 2017 Total Revenues of
$3.551 Billion , a 15 Percent Increase Over 2016 and a 17 Percent Volume Increase - 2017 GAAP Diluted EPS of
$1.97 Per Share, a 12 Percent Increase Over 2016; Non-GAAP Diluted EPS of$5.86 Per Share, a 27 Percent Increase Over 2016 - Continued Double-Digit Volume Growth of Soliris in 2017 Despite Rapid Enrollment in ALXN1210 Trials
- Initial Launches Underway for Soliris in Patients with AchR Antibody-Positive Generalized Myasthenia Gravis (gMG) in the
U.S. ,Germany andJapan - Data from ALXN1210 Phase 3 PNH Naive and Switch Studies Expected in Second Quarter of 2018
- Four New Independent Directors With Deep Biopharmaceutical Experience Appointed to
Alexion 's Board of Directors - 2018 Guidance: Revenue
$3.850 to$3.950 Billion ; GAAP Diluted EPS$4.35 to$4.75 Per Share; Non-GAAP Diluted EPS$6.60 to$6.80 Per Share
Total revenues in the fourth quarter were
"2017 was a year of rapid transformation for
Full Year 2017 Financial Highlights
- Soliris® (eculizumab) net product sales were
$3,144.1 million , compared to$2,843.2 million in 2016, representing an 11 percent increase. Soliris volume increased 11 percent year-over-year. - Strensiq® (asfotase alfa) net product sales were
$339.8 million , compared to$209.4 million in 2016, representing a 62 percent increase. Strensiq volume increased 74 percent year-over-year.
- Kanuma® (sebelipase alfa) net product sales were
$65.6 million , compared to$29.1 million in 2016, representing a 125 percent increase. Kanuma volume increased 136 percent year-over-year.
- GAAP cost of sales was
$454.2 million , inclusive of restructuring related expenses of$152.1 million , compared to$258.3 million in 2016. Non-GAAP cost of sales was$285.8 million , compared to$236.4 million in 2016. - GAAP R&D expense was
$878.4 million , inclusive of restructuring related expenses of$16.3 million , compared to$757.2 million in 2016. Non-GAAP R&D expense was$736.3 million , compared to$690.0 million in 2016. - GAAP SG&A expense was
$1,094.4 million , inclusive of restructuring related expenses of$10.9 million , compared to$953.0 million in 2016. Non-GAAP SG&A expense was$927.8 million , compared to$829.3 million in 2016. - GAAP income tax expense was
$104.5 million , compared to$176.8 million in 2016. GAAP income tax expense includes a$45.8 million charge related toU.S. tax reform. The charge fromU.S. tax reform includes a transition tax expense of$177.9 million and deferred tax expense related to the new GILTI minimum tax of$165.4 million , partially offset by the$297.5 million benefit of revaluing balance sheet taxes. Non-GAAP income tax expense was$186.7 million , compared to$182.8 million in 2016. Both GAAP and non-GAAP income tax expense for 2017 include a benefit from the conclusion of a routineIRS audit for the years 2013 and 2014. - GAAP diluted EPS was
$1.97 per share, inclusive of restructuring and related expenses of$286.5 million , compared to$1.76 per share in 2016. Non-GAAP diluted EPS was$5.86 per share, compared to$4.62 per share in 2016.
Fourth Quarter 2017 Financial Highlights
- Soliris net product sales were
$791.9 million , compared to$748.7 million in the fourth quarter of 2016, representing a 6 percent increase. Soliris volume increased 6 percent year-over-year. - Strensiq net product sales were
$95.6 million , compared to$70.5 million in the fourth quarter of 2016, representing a 36 percent increase. Strensiq volume increased 43 percent year-over-year.
- Kanuma net product sales were
$21.9 million , compared to$11.0 million in the fourth quarter of 2016, representing a 99 percent increase. Kanuma volume increased 82 percent year-over-year.
- GAAP cost of sales was
$144.6 million , inclusive of restructuring related expenses of$69.1 million , compared to$67.6 million in the same quarter last year. Non-GAAP cost of sales was$72.5 million , compared to$62.3 million in the same quarter last year. - GAAP R&D expense was
$265.0 million , inclusive of restructuring related expenses of$15.3 million , compared to$205.9 million in the same quarter last year. Non-GAAP R&D expense was$188.6 million , compared to$186.1 million in the same quarter last year. - GAAP SG&A expense was
$296.4 million , inclusive of restructuring related expenses of$4.5 million , compared to$258.5 million in the same quarter last year. Non-GAAP SG&A expense was$245.2 million , compared to$234.0 million in the same quarter last year. - GAAP income tax expense was
$59.3 million , compared to$11.7 million in the same quarter last year, driven primarily by the$45.8 million charge related toU.S. tax reform. Non-GAAP income tax expense was$46.8 million , compared to$37.7 million in the same quarter last year. - GAAP diluted EPS was
$0.13 per share, inclusive of restructuring and related expenses of$95.1 million , compared to$0.41 per share in the same quarter last year. Non-GAAP diluted EPS was$1.48 per share, compared to$1.26 per share in the fourth quarter of 2016.
Board of Directors Update
In the last six months,
Research and Development
Complement Portfolio Updates
- Soliris® (eculizumab)- Generalized Myasthenia Gravis (gMG): In
December 2017 , theMinistry of Health, Labour and Welfare (MHLW) inJapan approved Soliris as a treatment for patients with gMG who are anti-acetylcholine receptor (AchR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). - Soliris (eculizumab)- Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD): Enrollment is complete in the PREVENT study, a single, multinational, placebo-controlled Phase 3 trial of Soliris in patients with NMOSD.
Alexion expects to report data in mid-2018. - ALXN1210- Paroxysmal Nocturnal Hemoglobinuria (PNH): Enrollment is complete in a Phase 3 trial comparing ALXN1210 administered intravenously every eight weeks to Soliris in complement inhibitor treatment-naive patients with PNH and in a Phase 3 PNH Switch study of ALXN1210 administered intravenously every eight weeks compared to patients currently treated with Soliris.
Alexion expects to report data from these studies in the second quarter of 2018. - ALXN1210- Atypical Hemolytic Uremic Syndrome (aHUS): Enrollment and dosing are ongoing in a Phase 3 trial with ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naive adolescent and adult patients with aHUS. Enrollment is expected to be complete in the second quarter of 2018 and
Alexion expects to report data from this study in the fourth quarter of 2018. Enrollment and dosing are also ongoing in a Phase 3 trial of ALXN1210 in pediatric patients with aHUS. - ALXN1210- Subcutaneous:
Alexion plans to initiate in late 2018 a single, PK-based Phase 3 study of ALXN1210 delivered subcutaneously once per week to support registration in PNH and aHUS. InDecember 2017 ,Alexion entered into a collaboration and license agreement with Halozyme Therapeutics, Inc. that enables the Company to useHalozyme's ENHANZE® drug-delivery technology in the development of subcutaneous formulations for its portfolio of products, including a next-generation subcutaneous formulation of ALXN1210 to potentially further extend the dosing interval to once every two weeks or once per month.
2018 Financial Guidance
|
|||||||
Total revenues | |||||||
Soliris revenues | |||||||
Metabolic revenues | |||||||
R&D (% total revenues) | |||||||
GAAP | 20% to 22% | ||||||
Non-GAAP | 18% to 20% | ||||||
SG&A (% total revenues) | |||||||
GAAP | 26% to 28% | ||||||
Non-GAAP | 23% to 24% | ||||||
Operating margin | |||||||
GAAP | 31% to 34% | ||||||
Non-GAAP | 48% to 49% | ||||||
Earnings per share | |||||||
GAAP | |||||||
Non-GAAP | |||||||
2018 financial guidance assumes the following:
- A foreign currency benefit, net of hedging activities, of
$45 million to$55 million - Unfavorable Soliris revenue impact of
$90 million to$110 million from ALXN1210 and other clinical trial recruitment versus prior year - GAAP effective tax rate of 15 to 17 percent; non-GAAP effective tax rate of 16 to 18 percent (both inclusive of Alexion's provisional assessment of the impact of
U.S. tax reform)
Alexion's 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 and related activity outside of the previously announced activities that may occur after the day prior to the date of this press release.
Conference Call/Webcast Information:
About
[ALXN-E]
This press release contains forward-looking statements, including statements related to guidance regarding anticipated financial results for 2018, anticipated savings, costs and expenses related to the Company's 2017 restructuring, the expected timing of data disclosure, anticipated impact of ALXN1210 and other clinical trial recruitment, plans for regulatory filings and clinical programs for our product candidates, anticipated changes to the Company's R&D strategy and the potential impact of
In addition to financial information prepared in accordance with GAAP, this press release also contains non-GAAP financial measures that
Prior year amounts may have been adjusted to conform to current year rounding presentation.
(Tables Follow)
TABLE 1: CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(in millions, except per share amounts) | |||||||||||||||||
(unaudited) | |||||||||||||||||
Three months ended | Twelve months ended | ||||||||||||||||
2017 | 2016(1) | 2017 | 2016(1) | ||||||||||||||
Net product sales | $ | 909.4 | $ | 830.2 | $ | 3,549.5 | $ | 3,081.7 | |||||||||
Other revenue | 0.3 | 0.6 | 1.6 | 2.4 | |||||||||||||
Total revenues | 909.7 | 830.8 | 3,551.1 | 3,084.1 | |||||||||||||
Cost of sales | 144.6 | 67.6 | 454.2 | 258.3 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 265.0 | 205.9 | 878.4 | 757.2 | |||||||||||||
Selling, general and administrative | 296.4 | 258.5 | 1,094.4 | 953.0 | |||||||||||||
Amortization of purchased intangible assets | 80.0 | 80.0 | 320.1 | 322.2 | |||||||||||||
Change in fair value of contingent consideration | 9.2 | 5.0 | 41.0 | 35.7 | |||||||||||||
Acquisition-related costs | — | — | — | 2.3 | |||||||||||||
Restructuring expenses | 5.9 | 1.3 | 104.6 | 3.0 | |||||||||||||
Impairment of intangible assets | — | 85.0 | 31.0 | 85.0 | |||||||||||||
Total operating expenses | 656.5 | 635.7 | 2,469.5 | 2,158.4 | |||||||||||||
Operating income | 108.6 | 127.5 | 627.4 | 667.4 | |||||||||||||
Other income and expense: | |||||||||||||||||
Investment income | 5.6 | 2.9 | 18.5 | 10.9 | |||||||||||||
Interest expense | (25.1 | ) | (24.4 | ) | (98.4 | ) | (96.9 | ) | |||||||||
Other income (expense) | 0.2 | (1.5 | ) | 0.3 | (5.2 | ) | |||||||||||
Income before income taxes | 89.3 | 104.5 | 547.8 | 576.2 | |||||||||||||
Income tax expense | 59.3 | 11.7 | 104.5 | 176.8 | |||||||||||||
Net income | $ | 30.0 | $ | 92.8 | $ | 443.3 | $ | 399.4 | |||||||||
Earnings per common share | |||||||||||||||||
Basic | $ | 0.13 | $ | 0.41 | $ | 1.98 | $ | 1.78 | |||||||||
Diluted | $ | 0.13 | $ | 0.41 | $ | 1.97 | $ | 1.76 | |||||||||
Shares used in computing earnings per common share | |||||||||||||||||
Basic | 223.3 | 223.8 | 223.9 | 224.3 | |||||||||||||
Diluted | 225.0 | 225.6 | 225.4 | 226.3 |
(1) | Prior year amounts may have been adjusted to conform to current year rounding presentation. |
TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS | |||||||||||||||||
(in millions, except per share amounts) | |||||||||||||||||
(unaudited) | |||||||||||||||||
Three months ended | Twelve months ended | ||||||||||||||||
2017 | 2016(4) | 2017 | 2016(4) | ||||||||||||||
GAAP net income | $ | 30.0 | $ | 92.8 | $ | 443.3 | $ | 399.4 | |||||||||
Before tax adjustments: | |||||||||||||||||
Cost of sales: | |||||||||||||||||
Share-based compensation | 3.0 | 2.9 | 11.1 | 11.1 | |||||||||||||
Fair value adjustment in inventory acquired | — | 2.4 | 5.2 | 10.8 | |||||||||||||
Restructuring related expenses (1) | 69.1 | — | 152.1 | — | |||||||||||||
Research and development expense: | |||||||||||||||||
Share-based compensation | 21.1 | 13.8 | 76.4 | 57.6 | |||||||||||||
Upfront and milestone payments related to licenses and collaborations | 40.0 | 6.0 | 49.4 | 9.6 | |||||||||||||
Restructuring related expenses (1) | 15.3 | — | 16.3 | — | |||||||||||||
Selling, general and administrative expense: | |||||||||||||||||
Share-based compensation | 46.7 | 24.5 | 155.7 | 123.7 | |||||||||||||
Restructuring related expenses (1) | 4.5 | — | 10.9 | — | |||||||||||||
Amortization of purchased intangible assets | 80.0 | 80.0 | 320.1 | 322.2 | |||||||||||||
Change in fair value of contingent consideration | 9.2 | 5.0 | 41.0 | 35.7 | |||||||||||||
Acquisition-related costs | — | — | — | 2.3 | |||||||||||||
Restructuring expenses (1) | 5.9 | 1.3 | 104.6 | 3.0 | |||||||||||||
Impairment of intangible assets (2) | — | 85.0 | 31.0 | 85.0 | |||||||||||||
Other income and expense: | |||||||||||||||||
Restructuring related expenses (1) | 0.3 | — | 2.6 | — | |||||||||||||
Adjustments to income tax expense (3) | 12.5 | (26.0 | ) | (82.2 | ) | (6.0 | ) | ||||||||||
Non-GAAP net income | $ | 337.6 | $ | 287.7 | $ | 1,337.5 | $ | 1,054.4 | |||||||||
GAAP earnings per common share - diluted | $ | 0.13 | $ | 0.41 | $ | 1.97 | $ | 1.76 | |||||||||
Non-GAAP earnings per common share - diluted | $ | 1.48 | $ | 1.26 | $ | 5.86 | $ | 4.62 | |||||||||
Shares used in computing diluted earnings per common share (GAAP) | 225.0 | 225.6 | 225.4 | 226.3 | |||||||||||||
Shares used in computing diluted earnings per common share (non-GAAP) | 227.6 | 227.8 | 228.1 | 228.3 | |||||||||||||
(1) | The following table summarizes the total restructuring and related expenses recorded by type of activity and the classification within the Reconciliation of GAAP to non-GAAP Financial Results: |
Three months ended | Twelve months ended | |||||||||||||||||||||||||||||||
Employee | Asset- | Employee | Asset- | |||||||||||||||||||||||||||||
Separation | Related | Separation | Related | |||||||||||||||||||||||||||||
Costs | Charges | Other | Total | Costs | Charges | Other | Total | |||||||||||||||||||||||||
Cost of Sales | $ | — | $ | 69.1 | $ | — | $ | 69.1 | $ | — | $ | 152.1 | $ | — | $ | 152.1 | ||||||||||||||||
Research & Development | — | 15.3 | — | 15.3 | — | 16.3 | — | 16.3 | ||||||||||||||||||||||||
Selling , General and Administrative | — | 4.5 | — | 4.5 | — | 10.9 | — | 10.9 | ||||||||||||||||||||||||
Restructuring Expense | 1.0 | — | 4.9 | 5.9 | 87.3 | — | 17.3 | 104.6 | ||||||||||||||||||||||||
Other expense | — | — | 0.3 | 0.3 | — | — | 2.6 | 2.6 | ||||||||||||||||||||||||
$ | 1.0 | $ | 88.9 | $ | 5.2 | $ | 95.1 | $ | 87.3 | $ | 179.3 | $ | 19.9 | $ | 286.5 |
(2) | In the second quarter 2017, we recognized an impairment charge of |
|
(3) |
|
|
(4) | Prior year amounts may have been adjusted to conform to current year rounding presentation. |
TABLE 3: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL GUIDANCE | |||||||||
(in millions, except per share amounts and percentages) | |||||||||
(unaudited) | |||||||||
Twelve months ending | |||||||||
Low | High | ||||||||
GAAP net income | $ | 982 | $ | 1,074 | |||||
Before tax adjustments: | |||||||||
Share-based compensation | 247 | 217 | |||||||
Amortization of purchased intangible assets | 320 | 320 | |||||||
Change in fair value of contingent consideration | 15 | 15 | |||||||
Restructuring and related expenses | 70 | 30 | |||||||
Adjustments to income tax expense | (129 | ) | (106 | ) | |||||
Non-GAAP net income | $ | 1,505 | $ | 1,550 | |||||
Diluted GAAP earnings per common share | $ | 4.35 | $ | 4.75 | |||||
Diluted non-GAAP earnings per common share | $ | 6.60 | $ | 6.80 | |||||
Operating expense and margin (% total revenues) | |||||||||
GAAP research and development expense | 22 | % | 20 | % | |||||
Share-based compensation | (2 | )% | (2 | )% | |||||
Restructuring related expenses | 0 | % | 0 | % | |||||
Non-GAAP research and development expense | 20 | % | 18 | % | |||||
GAAP selling, general and administrative expense | 28 | % | 26 | % | |||||
Share-based compensation | (4 | )% | (3 | )% | |||||
Restructuring related expenses | 0 | % | 0 | % | |||||
Non-GAAP selling, general and administrative expense | 24 | % | 23 | % | |||||
GAAP operating margin | 31 | % | 34 | % | |||||
Share-based compensation | 7 | % | 6 | % | |||||
Amortization of purchased intangible assets | 8 | % | 8 | % | |||||
Change in fair value of contingent consideration | 0 | % | 0 | % | |||||
Restructuring and related expenses | 2 | % | 1 | % | |||||
Non-GAAP operating margin | 48 | % | 49 | % | |||||
Income tax expense (% of income before income taxes) |
|||||||||
GAAP income tax expense | 17 | % | 15 | % | |||||
Tax effect of pre-tax adjustments to GAAP net income |
1 | % | 1 | % | |||||
Non-GAAP income tax expense | 18 | % | 16 | % |
TABLE 4: NET PRODUCT SALES BY GEOGRAPHY | ||||||||||||||||
(in millions) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three months ended | Twelve months ended | |||||||||||||||
2017 | 2016(1) | 2017 | 2016(1) | |||||||||||||
Soliris |
||||||||||||||||
$ | 321.5 | $ | 285.4 | $ | 1,235.0 | $ | 1,058.5 | |||||||||
246.9 | 237.0 | 985.2 | 939.7 | |||||||||||||
86.7 | 80.8 | 328.1 | 303.8 | |||||||||||||
Rest of World | 136.8 | 145.5 | 595.8 | 541.2 | ||||||||||||
Total Soliris | $ | 791.9 | $ | 748.7 | $ | 3,144.1 | $ | 2,843.2 | ||||||||
Strensiq |
||||||||||||||||
$ | 76.2 | $ | 59.7 | $ | 280.1 | $ | 177.5 | |||||||||
12.3 | 5.4 | 35.6 | 15.3 | |||||||||||||
5.3 | 3.6 | 18.6 | 13.0 | |||||||||||||
Rest of World | 1.8 | 1.8 | 5.5 | 3.6 | ||||||||||||
Total Strensiq |
$ | 95.6 | $ | 70.5 | $ | 339.8 | $ | 209.4 | ||||||||
Kanuma |
||||||||||||||||
$ | 11.2 | $ | 8.4 | $ | 42.4 | $ | 20.4 | |||||||||
5.9 | 1.7 | 14.6 | 6.3 | |||||||||||||
0.9 | 0.4 | 2.7 | 1.3 | |||||||||||||
Rest of World | 3.9 | 0.5 | 5.9 | 1.1 | ||||||||||||
Total Kanuma | $ | 21.9 | $ | 11.0 | $ | 65.6 | $ | 29.1 | ||||||||
Net Product Sales |
||||||||||||||||
$ | 408.9 | $ | 353.5 | $ | 1,557.5 | $ | 1,256.4 | |||||||||
265.1 | 244.1 | 1,035.4 | 961.3 | |||||||||||||
92.9 | 84.8 | 349.4 | 318.1 | |||||||||||||
Rest of World | 142.5 | 147.8 | 607.2 | 545.9 | ||||||||||||
Total Net Product Sales | $ | 909.4 | $ | 830.2 | $ | 3,549.5 | $ | 3,081.7 |
(1) | Prior year amounts may have been adjusted to conform to current year rounding presentation. |
TABLE 5: CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(in millions) | ||||||||
(unaudited) | ||||||||
2017 | 2016(2) | |||||||
Cash and cash equivalents | $ | 584.4 | $ | 966.0 | ||||
Marketable securities | 889.7 | 327.4 | ||||||
Trade accounts receivable, net | 726.5 | 649.6 | ||||||
Inventories | 460.4 | 374.7 | ||||||
Prepaid expenses and other current assets (1) | 292.9 | 260.5 | ||||||
Property, plant and equipment, net | 1,325.4 | 1,035.6 | ||||||
Intangible assets, net | 3,954.4 | 4,303.1 | ||||||
5,037.4 | 5,037.4 | |||||||
Other assets | 312.2 | 299.0 | ||||||
Total assets | $ | 13,583.3 | $ | 13,253.3 | ||||
Accounts payable and accrued expenses | $ | 710.2 | $ | 572.1 | ||||
Deferred revenue | 15.9 | 36.6 | ||||||
Current portion of long-term debt | 167.4 | 167.0 | ||||||
Current portion of contingent consideration | — | 23.8 | ||||||
Other current liabilities | 59.0 | 23.4 | ||||||
Long-term debt, less current portion | 2,720.7 | 2,888.1 | ||||||
Contingent consideration | 168.9 | 129.1 | ||||||
Facility lease obligations | 342.9 | 233.4 | ||||||
Deferred tax liabilities | 365.0 | 395.5 | ||||||
Other liabilities | 140.2 | 90.5 | ||||||
Total liabilities | 4,690.2 | 4,559.5 | ||||||
Total stockholders' equity (1) | 8,893.1 | 8,693.8 | ||||||
Total liabilities and stockholders' equity | $ | 13,583.3 | $ | 13,253.3 |
(1) | In |
|
(2) | Prior year amounts may have been adjusted to conform to current year rounding presentation. |
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