- 3Q18 total revenues of
$1,026.5 million , a 20 percent increase over 3Q17 and a 26 percent volume increase - 3Q18 GAAP diluted EPS of
$1.47 per share; non-GAAP diluted EPS of$2.02 per share - Updated 2018 full-year guidance given the strength of the business
- Positive topline Phase 3 data for eculizumab in patients with neuromyelitis optica spectrum disorder (NMOSD); regulatory submissions planned for early 2019
- Announced agreement to acquire Syntimmune and collaboration with Dicerna
"We continued to execute on our key objectives this quarter, further strengthening our core business and again delivering strong top and bottom-line growth," said
Third Quarter 2018 Financial Highlights
- Total net product sales were
$1,026.5 million in the third quarter of 2018, compared to$1,044.7 million in the second quarter of 2018. Second quarter revenue benefited from favorable timing of orders from certain non-U.S. markets that access Alexion medicines through a tender process as well as approximately$18.2 million related to order timing ahead of theJuly 4th holiday inthe United States , compared to the third quarter of 2018. - Soliris® (eculizumab) net product sales were
$888.0 million , compared to$755.4 million in the third quarter of 2017, representing an 18 percent increase. Soliris® volume increased 24 percent year-over-year. - Strensiq® (asfotase alfa) net product sales were
$113.2 million , compared to$87.0 million in the third quarter of 2017, representing a 30 percent increase. Strensiq® volume increased 37 percent year-over-year. - Kanuma® (sebelipase alfa) net product sales were
$25.3 million , compared to$16.4 million in the third quarter of 2017, representing a 54 percent increase. Kanuma® volume increased 74 percent year-over-year. - GAAP cost of sales was
$90.6 million , compared to$157.0 million in the same quarter last year. Non-GAAP cost of sales was$87.3 million , compared to$70.8 million in the same quarter last year. - GAAP R&D expense was
$174.8 million , compared to$195.7 million in the same quarter last year. Non-GAAP R&D expense was$162.3 million , compared to$175.7 million in the same quarter last year. - GAAP SG&A expense was
$258.7 million , compared to$270.6 million in the same quarter last year. Non-GAAP SG&A expense was$224.5 million , compared to$229.0 million in the same quarter last year. - GAAP income tax expense was
$11.2 million , compared to an income tax benefit of$19.8 million in the same quarter last year. Non-GAAP income tax expense was$75.8 million , compared to$35.7 million in the same quarter last year. Both GAAP and non-GAAP income tax benefit /expense for the third quarter of 2017 included a benefit from the conclusion of a routineIRS audit for the 2013-2014 years. - GAAP diluted EPS was
$1.47 per share, compared to$0.35 per share in the same quarter last year. The third quarter of 2018 included$18.2 million of restructuring and related expenses compared to$164.7 million in the third quarter of 2017. Non-GAAP diluted EPS was$2.02 per share, compared to$1.44 per share in the third quarter of 2017.
Research and Development
PHASE 3
- UltomirisTM - Paroxysmal Nocturnal Hemoglobinuria (PNH): Applications for the approval of UltomirisTM (also known as ALXN1210) in adults with PNH have been accepted by regulatory authorities in the U.S., the
European Union (EU) andJapan .The U.S. Food and Drug Administration (FDA ) has set a Prescription Drug User Fee Act (PDUFA) date ofFebruary 18, 2019 , as part of an expedited eight-month review following the company's use of a rare disease priority review voucher. The applications are supported by comprehensive data from two rigorous Phase 3 clinical studies. InSeptember 2018 , UltomirisTM was granted Orphan Drug Designation inJapan . In addition, a Phase 3 study of UltomirisTM in children and adolescents with PNH is currently underway. - ALXN1210- Atypical Hemolytic Uremic Syndrome (aHUS): Enrollment is complete in the Phase 3 trial of ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naïve adolescent and adult patients with aHUS. Results from this study are expected in early 2019. Alexion intends to file for regulatory approval in aHUS following approval in PNH. A Phase 3 study of ALXN1210 in children with aHUS is currently underway.
- ALXN1210- Subcutaneous: In late 2018,Alexion plans to initiate a single, PK-based Phase 3 study of ALXN1210 delivered subcutaneously once per week to support registration in PNH and aHUS.
- Eculizumab - Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD): In
September 2018 , Alexion announced positive results from the Phase 3 PREVENT study, in which patients with anti-aquaporin-4 (AQP4) auto antibody-positive NMOSD received eculizumab or placebo on top of stable standard-of-care therapy. The study met its primary endpoint of time to first adjudicated on-trial relapse, demonstrating that treatment with eculizumab reduced the risk of relapse by 94.2 percent compared to placebo (p<0.0001). At 48 weeks, 97.9 percent of patients receiving eculizumab were free of relapse compared to 63.2 percent of patients receiving placebo. No cases of meningococcal infection were observed. Eculizumab was generally well tolerated with a safety profile consistent with that seen in previous clinical studies and real-world use in its three approved indications. Based on the significant need for an approved treatment, the company is rapidly preparing regulatory submissions in the U.S., EU andJapan , and expects to submit applications in early 2019. - WTX101 - Wilson Disease: Enrollment is underway in a Phase 3 study of WTX101 in Wilson disease, a rare genetic disorder with devastating hepatic and neurological consequences. The study is now powered for superiority. WTX101 is a first-in-class oral copper-binding agent with a unique mechanism of action to access and bind to serum copper and promote its removal from the liver.
PHASE 1/2
- SYNT001: In
September 2018 , Alexion announced an agreement to acquire Syntimmune. Pending relevant regulatory approvals, the acquisition is expected to close in the fourth quarter of 2018. The acquisition will add anti-FcRn antibody SYNT001 to the company's clinical pipeline. SYNT001 is currently in Phase 1b/2a development in patients with warm autoimmune hemolytic anemia (WAIHA) and in patients with pemphigus vulgaris (PV) or pemphigus foliaceus (PF). In 2019, the company plans to initiate two pivotal trials - one in WAIHA following successful completion of the current Phase 1b/2a study, and one in an undisclosed indication. - ALXN1810 - Subcutaneous: Alexion initiated a Phase 1 study of subcutaneous ALXN1210 co-administered with Halozyme's ENHANZE® drug-delivery technology, PH20, in the third quarter of 2018. Pending co-formulation data, this next-generation subcutaneous formulation will be called ALXN1810 and has the potential to further extend the dosing interval to once every two weeks or once per month.
PRE-CLINICAL
- Dicerna - GalXCTM : In
October 2018 , Alexion began a collaboration withDicerna Pharmaceuticals, Inc. to jointly discover and develop up to four subcutaneously delivered GalXCTM RNA interference (RNAi) candidates, currently in pre-clinical development, for the treatment of complement-mediated diseases. - Complement Pharma - CP010: Alexion is collaborating with Complement Pharma to co-develop CP010, a pre-clinical C6 inhibitor that has the potential to treat multiple neurological disorders.
2018 Financial Guidance
Alexion is increasing revenue guidance, non-GAAP operating margin guidance, and non-GAAP EPS guidance. Full guidance updates are outlined below.
Previous (as of July 26, 2018) | Updated (as of October 24, 2018) | |||||||
Total revenues | $3,980 to $4,010 million | $4,020 to $4,050 million | ||||||
Soliris revenues | $3,420 to $3,440 million | $3,460 to $3,480 million | ||||||
Metabolic revenues | $560 to $570 million | $560 to $570 million | ||||||
R&D (% total revenues) | ||||||||
GAAP | 20% to 21% | 18% to 19% | ||||||
Non-GAAP | 18% to 19% | 16% to 17% | ||||||
SG&A (% total revenues) | ||||||||
GAAP | 26% to 27% | 26% to 27% | ||||||
Non-GAAP | 22% to 23% | 22% to 23% | ||||||
Operating margin | ||||||||
GAAP | 11% to 14% | 0% to 5% | ||||||
Non-GAAP | 49% to 50% | 51% to 52% | ||||||
Earnings (loss) per share | ||||||||
GAAP | $1.25 to $1.50 | $-0.08 to $0.26 | ||||||
Non-GAAP | $7.00 to $7.15 | $7.45 to $7.60 | ||||||
Updated 2018 financial guidance assumes the following:
- A foreign currency headwind, net of hedging activities, of approximately
$10 million . - Unfavorable Soliris® revenue impact of
$90 to $110 million from ALXN1210 and other clinical trial recruitment versus prior year. - GAAP guidance reflects the preliminary financial impact of the announced agreement to acquire Syntimmune and the recently announced collaboration with Dicerna. Alexion expects to account for Syntimmune as an asset acquisition during the fourth quarter of 2018. In addition, non-GAAP financial guidance includes the preliminary impact of operating expenses for Syntimmune.
- GAAP effective tax rate of 70 to 150 percent impacted by non-deductible pre-tax acquisition charges; non-GAAP effective tax rate of 14 to 15 percent.
Alexion expects to incur additional restructuring and related expenses in 2018 of up to approximately
Alexion’s financial guidance is based on current foreign exchange rates net of hedging activities and does not include the effect of acquisitions, license and collaboration agreements, intangible asset impairments, litigation charges, changes in fair value of contingent consideration or restructuring and related activity outside of the previously announced activities that may occur after the issuance of this press release.
Conference Call/Webcast Information:
Alexion will host a conference call/audio webcast to discuss the third quarter 2018 results today at
About Alexion
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the
[ALXN-E]
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995, including statements related to: updated guidance regarding anticipated financial results for 2018 (and the assumptions related to such guidance); the strength of our core business; plans to make future regulatory submissions for eculizumab and ALXN1210 and the timing related thereto (and that eculizumab could be the first approved therapy for patients with NMOSD); Soliris® in gMG is experiencing sustained growth; Company continues to look for additional business development opportunities and advancing internal programs to further long-term growth; timing for the initiation of clinical trials and the timing of expected receipt/release of results of clinical trials; the anticipated closing of, and closing date for, the acquisition of Syntimmune; potential benefits of current products and products under development and in clinical trials (including further extended dosing intervals); anticipated restructuring and related expenses in 2018; Alexion's future clinical, regulatory, and commercial plans for ALXN1210 and other product candidates; goal of building out the clinical pipeline; our strategy and plans; and potential of our commercial business and pipeline programs.Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ materially from those forward-looking statements, including for example: our dependence on sales from our principal product (Soliris®); future competition from biosimilars and other products; decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of our products; delays or failure of product candidates to obtain regulatory approval; delays or the inability to launch product candidates due to regulatory restrictions, anticipated expense or other matters; interruptions or failures in the manufacture and supply of our products and our product candidates; failure to satisfactorily address matters raised by the
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, restructuring and related expenses, upfront payments related to licenses and collaborations, acquired in-process research and development assets, impairment of intangible assets, change in value of equity securities without readily determinable fair values, litigation charges, gain or loss on sale of a business or asset and certain 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 2018 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 nine month periods ended
Prior year amounts may have been adjusted to conform to current year rounding presentation.
(Tables Follow)
ALEXION PHARMACEUTICALS, INC. |
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TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in millions, except per share amounts) |
|||||||||||||||||||||||||
(unaudited) |
|||||||||||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||||||||||
September 30 | September 30 | ||||||||||||||||||||||||
2018 | 2017(1) | 2018 | 2017(1) | ||||||||||||||||||||||
Net product sales | $ | 1,026.5 | $ | 858.8 | $ | 3,001.6 | $ | 2,640.1 | |||||||||||||||||
Other revenue | — | 0.3 | 0.8 | 1.3 | |||||||||||||||||||||
Total revenues | 1,026.5 | 859.1 | 3,002.4 | 2,641.4 | |||||||||||||||||||||
Cost of sales | 90.6 | 157.0 | 277.5 | 309.6 | |||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||
Research and development | 174.8 | 195.7 | 524.8 | 613.4 | |||||||||||||||||||||
Selling, general and administrative | 258.7 | 270.6 | 793.1 | 798.0 | |||||||||||||||||||||
Acquired in-process research and development | — | — | 803.7 | — | |||||||||||||||||||||
Amortization of purchased intangible assets | 80.0 | 80.0 | 240.1 | 240.1 | |||||||||||||||||||||
Change in fair value of contingent consideration | 53.5 | 3.7 | 110.9 | 31.8 | |||||||||||||||||||||
Restructuring expenses | 10.3 | 72.0 | 26.4 | 98.7 | |||||||||||||||||||||
Impairment of intangible assets | — | — | — | 31.0 | |||||||||||||||||||||
Total operating expenses | 577.3 | 622.0 | 2,499.0 | 1,813.0 | |||||||||||||||||||||
Operating income | 358.6 | 80.1 | 225.9 | 518.8 | |||||||||||||||||||||
Other income and expense: | |||||||||||||||||||||||||
Investment income | 5.9 | 4.5 | 119.4 | 12.9 | |||||||||||||||||||||
Interest expense | (24.6 | ) | (25.0 | ) | (73.7 | ) | (73.3 | ) | |||||||||||||||||
Other income (expense) | 2.2 | (1.4 | ) | 3.5 | 0.1 | ||||||||||||||||||||
Income before income taxes | 342.1 | 58.2 | 275.1 | 458.5 | |||||||||||||||||||||
Income tax expense (benefit) | 11.2 | (19.8 | ) | 152.5 | 45.2 | ||||||||||||||||||||
Net income | $ | 330.9 | $ | 78.0 | $ | 122.6 | $ | 413.3 | |||||||||||||||||
Earnings per common share | |||||||||||||||||||||||||
Basic | $ | 1.48 | $ | 0.35 | $ | 0.55 | $ | 1.84 | |||||||||||||||||
Diluted | $ | 1.47 | $ | 0.35 | $ | 0.55 | $ | 1.83 | |||||||||||||||||
Shares used in computing earnings per common share | |||||||||||||||||||||||||
Basic | 222.9 | 223.3 | 222.5 | 224.1 | |||||||||||||||||||||
Diluted | 224.6 | 225.0 | 224.2 | 225.5 |
(1) | Prior year amounts may have been adjusted to conform to current year rounding presentation. | |
ALEXION PHARMACEUTICALS, INC. |
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TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS |
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(in millions, except per share amounts) |
|||||||||||||||||||||||
(unaudited) |
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Three months ended | Nine months ended | ||||||||||||||||||||||
September 30 | September 30 | ||||||||||||||||||||||
2018 | 2017(8) | 2018 | 2017(8) | ||||||||||||||||||||
GAAP net income | $ | 330.9 | $ | 78.0 | $ | 122.6 | $ | 413.3 | |||||||||||||||
Before tax adjustments: | |||||||||||||||||||||||
Cost of sales: | |||||||||||||||||||||||
Share-based compensation | 3.3 | 3.2 | 12.2 | 8.1 | |||||||||||||||||||
Fair value adjustment in inventory acquired | — | — | — | 5.2 | |||||||||||||||||||
Restructuring related expenses (1) | — | 83.0 | 5.8 | 83.0 | |||||||||||||||||||
Research and development expense: | |||||||||||||||||||||||
Share-based compensation | 12.5 | 19.0 | 42.5 | 55.3 | |||||||||||||||||||
Upfront payments related to licenses and collaborations | — | — | — | 9.4 | |||||||||||||||||||
Restructuring related expenses (1) | — | 1.0 | 0.1 | 1.0 | |||||||||||||||||||
Selling, general and administrative expense: | |||||||||||||||||||||||
Share-based compensation | 29.8 | 35.2 | 96.2 | 109.0 | |||||||||||||||||||
Restructuring related expenses (1) | 7.9 | 6.4 | 18.0 | 6.4 | |||||||||||||||||||
Litigation charges (2) | — | — | 7.1 | — | |||||||||||||||||||
Gain on sale of asset (3) | (3.5 | ) | — | (3.5 | ) | — | |||||||||||||||||
Acquired in-process research and development (4) | — | — | 803.7 | — | |||||||||||||||||||
Amortization of purchased intangible assets | 80.0 | 80.0 | 240.1 | 240.1 | |||||||||||||||||||
Change in fair value of contingent consideration (5) | 53.5 | 3.7 | 110.9 | 31.8 | |||||||||||||||||||
Restructuring expenses (1) | 10.3 | 72.0 | 26.4 | 98.7 | |||||||||||||||||||
Impairment of intangible assets | — | — | — | 31.0 | |||||||||||||||||||
Investment income: | |||||||||||||||||||||||
Change in value of equity securities without readily determinable fair values (6) | — | — | (100.8 | ) | — | ||||||||||||||||||
Other income: | |||||||||||||||||||||||
Restructuring related expenses (1) | — | 2.3 | (0.1 | ) | 2.3 | ||||||||||||||||||
Adjustments to income tax expense (7) | (64.6 | ) | (55.5 | ) | (68.9 | ) | (94.7 | ) | |||||||||||||||
Non-GAAP net income | $ | 460.1 | $ | 328.3 | $ | 1,312.3 | $ | 999.9 | |||||||||||||||
GAAP earnings per common share - diluted | $ | 1.47 | $ | 0.35 | $ | 0.55 | $ | 1.83 | |||||||||||||||
Non-GAAP earnings per common share - diluted | $ | 2.02 | $ | 1.44 | $ | 5.78 | $ | 4.38 | |||||||||||||||
Shares used in computing diluted earnings per common share (GAAP) | 224.6 | 225.0 | 224.2 | 225.5 | |||||||||||||||||||
Shares used in computing diluted earnings per common share (non-GAAP) | 227.4 | 227.5 | 227.0 | 228.2 | |||||||||||||||||||
(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: |
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Three months ended | Nine months ended | |||||||||||||||||||||||||||||||||||||||||||||
September 30, 2018 | September 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||
Employee |
Asset- |
Other | Total |
Employee |
Asset- |
Other | Total | |||||||||||||||||||||||||||||||||||||||
Cost of Sales | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 5.8 | $ | — | $ | 5.8 | ||||||||||||||||||||||||||||||
Research and Development |
|
— |
|
— |
|
— | — | — | 0.1 | — | 0.1 | |||||||||||||||||||||||||||||||||||
Selling, General and Administrative |
|
— |
|
7.9 |
|
— | 7.9 | — | 18.0 | — | 18.0 | |||||||||||||||||||||||||||||||||||
Restructuring Expense |
|
2.8 |
|
— |
|
7.5 | 10.3 | 6.9 | — | 19.5 | 26.4 | |||||||||||||||||||||||||||||||||||
Other (Income) Expense |
|
— |
|
— |
|
— | — | — | — | (0.1 | ) | (0.1 | ) | |||||||||||||||||||||||||||||||||
$ | 2.8 | $ | 7.9 | $ | 7.5 | $ | 18.2 | $ | 6.9 | $ | 23.9 | $ | 19.4 | $ | 50.2 | |||||||||||||||||||||||||||||||
(2) | During the second quarter of 2018, we recorded $7.1 million in litigation charges in connection with ongoing investigations. | |
(3) | In September 2018, we sold all assets, rights and obligations of the ALXN1101 program to a third party and, as a result, we recognized a gain on the sale of ALXN1101 during the three and nine months ended September 30, 2018. | |
(4) | During the second quarter of 2018, we completed the acquisition of Wilson Therapeutics AB. The acquisition was accounted for as an asset acquisition, as substantially all of the fair value of the gross assets acquired is concentrated in a single asset, WTX101, an early Phase III development asset. The value of the acquired in-process research and development asset related to WTX101 was expensed during the second quarter and nine months ended September 30, 2018 due to the stage of development of this asset. | |
(5) | The change in the expense associated with the fair value of contingent consideration for the three and nine months ended September 30, 2018, as compared to the same periods in 2017 was primarily due to amending certain contingent milestone payments due under our prior merger agreement with Enobia Pharma Corp. in September 2018 as well as due to increases in the likelihood and anticipated timing of payments for contingent consideration. | |
(6) | On January 1, 2018, we adopted a new standard that changes the accounting for equity investments and, as a result, we recognized an unrealized gain of $100.8 million in investment income during the first quarter and nine months ended September 30, 2018, respectively, to adjust our investment in Moderna Therapeutics, Inc. to fair value. | |
(7) | Alexion's non-GAAP income tax expense excludes the tax effect of pre-tax adjustments to GAAP profit and adjustments to provisional estimates of the impact of Tax Cuts and Jobs Act we recorded in Q4 2017. | |
(8) | Prior year amounts may have been adjusted to conform to current year rounding presentation. |
ALEXION PHARMACEUTICALS, INC. | |||||
TABLE 3: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL GUIDANCE | |||||
(in millions, except per share amounts and percentages) | |||||
(unaudited) | |||||
Twelve months ending | |||||
December 31, 2018 | |||||
Low | High | ||||
GAAP net (loss) income | $ (17) | $ 58 | |||
Before tax adjustments: | |||||
Share-based compensation | 215 | 200 | |||
Fair value adjustment of inventory acquired | - | - | |||
Upfront payments related to licenses and collaborations | 27 | 25 | |||
Acquired in-process research and development | 1,204 | 1,204 | |||
Amortization of purchased intangible assets | 320 | 320 | |||
Change in fair value of contingent consideration | 111 | 111 | |||
Restructuring and related expenses | 175 | 50 | |||
Change in value of equity securities without readily determinable fair values | (101) | (101) | |||
Litigation charges | 7 | 7 | |||
Gain on sale of asset | (4) | (4) | |||
Adjustments to income tax expense | (247) | (146) | |||
Non-GAAP net income | $ 1,691 | $ 1,725 | |||
Diluted GAAP earnings (loss) per common share |
$(0.08) |
$0.26 | |||
Diluted non-GAAP earnings per common share | $7.45 | $7.60 | |||
Operating expense and margin (% total revenues) | |||||
GAAP research and development expense | 19% | 18% | |||
Share-based compensation | 1% | 1% | |||
Upfront payments related to licenses and collaborations | 1% | 1% | |||
Restructuring related expenses | 0% | 0% | |||
Non-GAAP research and development expense | 17% | 16% | |||
GAAP selling, general and administrative expense | 27% | 26% | |||
Share-based compensation | 3% | 3% | |||
Restructuring related expenses | 0% | 0% | |||
Litigation charges | 0% | 0% | |||
Gain on sale of asset |
0% |
0% |
|||
Non-GAAP selling, general and administrative expense | 23% | 22% | |||
GAAP operating margin | 0% | 5% | |||
Share-based compensation | 5% | 5% | |||
Upfront payments related to license and collaborations | 1% | 1% | |||
Acquired in-process research and development | 30% | 30% | |||
Litigation charges | 0% | 0% | |||
Gain on sale of asset | 0% | 0% | |||
Amortization of purchased intangible assets | 8% | 8% | |||
Change in fair value of contingent consideration | 3% | 3% | |||
Restructuring and related expenses | 4% | 1% | |||
Non-GAAP operating margin | 51% | 52% | |||
Income tax expense (% of income before income taxes) | |||||
GAAP income tax expense | 150% | 70% | |||
Tax effect of pre-tax adjustments to GAAP net income and adjustments |
(135)% | (56)% | |||
Non-GAAP income tax expense | 15% | 14% |
Amounts may not foot due to rounding.
ALEXION PHARMACEUTICALS, INC. |
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TABLE 4: NET PRODUCT SALES BY GEOGRAPHY |
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(in millions) |
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(unaudited) |
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Three months ended | Nine months ended | ||||||||||||||||||||||||||
September 30 | September 30 | ||||||||||||||||||||||||||
2018 | 2017(1) | 2018 | 2017(1) | ||||||||||||||||||||||||
Soliris |
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United States | $ | 404.5 | $ | 307.6 | $ | 1,136.3 | $ | 913.5 | |||||||||||||||||||
Europe | 262.1 | 248.4 | 766.3 | 738.3 | |||||||||||||||||||||||
Asia Pacific | 98.2 | 81.8 | 277.3 | 241.4 | |||||||||||||||||||||||
Rest of World | 123.2 | 117.6 | 406.4 | 459.0 | |||||||||||||||||||||||
Total Soliris | $ | 888.0 | $ | 755.4 | $ | 2,586.3 | $ | 2,352.2 | |||||||||||||||||||
Strensiq |
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United States | $ | 86.6 | $ | 70.6 | $ | 275.7 | $ | 203.9 | |||||||||||||||||||
Europe | 16.6 | 9.6 | 47.0 | 23.3 | |||||||||||||||||||||||
Asia Pacific | 7.2 | 5.2 | 19.2 | 13.3 | |||||||||||||||||||||||
Rest of World | 2.8 | 1.6 | 7.1 | 3.7 | |||||||||||||||||||||||
Total Strensiq | $ | 113.2 | $ | 87.0 | $ | 349.0 | $ | 244.2 | |||||||||||||||||||
Kanuma |
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United States | $ | 13.7 | $ | 11.4 | $ | 38.6 | $ | 31.2 | |||||||||||||||||||
Europe | 4.7 | 3.6 | 16.4 | 8.7 | |||||||||||||||||||||||
Asia Pacific | 0.8 | 0.7 | 2.9 | 1.8 | |||||||||||||||||||||||
Rest of World | 6.1 | 0.7 | 8.4 | 2.0 | |||||||||||||||||||||||
Total Kanuma | $ | 25.3 | $ | 16.4 | $ | 66.3 | $ | 43.7 | |||||||||||||||||||
Net Product Sales |
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United States | $ | 504.8 | $ | 389.6 | $ | 1,450.6 | $ | 1,148.6 | |||||||||||||||||||
Europe | 283.4 | 261.6 | 829.7 | 770.3 | |||||||||||||||||||||||
Asia Pacific | 106.2 | 87.7 | 299.4 | 256.5 | |||||||||||||||||||||||
Rest of World | 132.1 | 119.9 | 421.9 | 464.7 | |||||||||||||||||||||||
Total Net Product Sales | $ | 1,026.5 | $ | 858.8 | $ | 3,001.6 | $ | 2,640.1 |
(1) | Prior year amounts may have been adjusted to conform to current year rounding presentation. |
ALEXION PHARMACEUTICALS, INC. |
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TABLE 5: CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in millions) |
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(unaudited) |
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September 30 | December 31 | ||||||||||
2018 | 2017(2) | ||||||||||
Cash and cash equivalents | $ | 1,228.9 | $ | 584.4 | |||||||
Marketable securities | 306.2 | 889.7 | |||||||||
Trade accounts receivable, net | 910.2 | 726.5 | |||||||||
Inventories | 432.7 | 460.4 | |||||||||
Prepaid expenses and other current assets | 370.4 | 292.9 | |||||||||
Property, plant and equipment, net | 1,443.4 | 1,325.4 | |||||||||
Intangible assets, net | 3,713.6 | 3,954.4 | |||||||||
Goodwill | 5,037.4 | 5,037.4 | |||||||||
Other assets | 400.8 | 312.2 | |||||||||
Total assets | $ | 13,843.6 | $ | 13,583.3 | |||||||
Accounts payable and accrued expenses | $ | 592.0 | $ | 710.2 | |||||||
Revolving credit facility | 250.0 | — | |||||||||
Current portion of long-term debt | 61.2 | 167.4 | |||||||||
Current portion of contingent consideration | 95.8 | — | |||||||||
Other current liabilities (1) | 28.4 | 74.9 | |||||||||
Long-term debt, less current portion | 2,533.3 | 2,720.7 | |||||||||
Contingent consideration | 179.4 | 168.9 | |||||||||
Facility lease obligation | 361.2 | 342.9 | |||||||||
Deferred tax liabilities | 442.8 | 365.0 | |||||||||
Other liabilities | 129.8 | 140.2 | |||||||||
Total liabilities | 4,673.9 | 4,690.2 | |||||||||
Total stockholders' equity (1) | 9,169.7 | 8,893.1 | |||||||||
Total liabilities and stockholders' equity | $ | 13,843.6 | $ | 13,583.3 |
(1) | In May 2014, the Financial Accounting Standards Board issued a comprehensive new standard which amends revenue recognition principles. We adopted this standard in the first quarter 2018. Upon adoption of the new standard, we reduced our deferred revenue balance reported in Other current liabilities by $10.4 million, with an offsetting increase of $6.0 million in retained earnings due to the cumulative impact of adopting this new standard. The adjusted deferred revenue balance, as of January 1, 2018, was $5.5 million. We recognized this amount in revenue in the first quarter of 2018. | |
(2) | Prior year amounts may have been adjusted to conform to current year rounding presentation. | |
View source version on businesswire.com: https://www.businesswire.com/news/home/20181024005225/en/
Source:
Alexion:
Media
Megan Goulart, 857-338-8634
Senior Director, Corporate Communications
or
Investors
Susan Altschuller, Ph.D., 857-338-8788
Vice President, Investor Relations