soliris sales 2019

On a GAAP basis, diluted EPS for the full year of 2019 was $10.70, inclusive of one-time tax benefits related to intra-entity asset transfers of intellectual property, compared to $0.35 in the prior year, inclusive of $1,183.0 million of expense related to the value of the in-process research and development assets acquired in 2018. Jun 28, 2019 11:20am. This website is intended only for residents of the United States. Senior Director, Corporate CommunicationsInvestors The company's 2019 financial guidance is also being provided on both a reported and a non-GAAP basis. By using our website, you agree to our use of cookies in accordance with our, Alexion Reports Third Quarter 2019 Results. Please refer to the attached Reconciliations of GAAP to non-GAAP Financial Results and GAAP to non-GAAP 2020 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, 2019 and 2018 and projected twelve months ending December 31, 2020. For the twelve months ended December 31, 2018, the change in the fair value of contingent consideration expense 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. Total revenues in the fourth quarter were $1,384.3 million, a 23 percent increase compared to the same period in 2018. Our key achievements include establishing ULTOMIRIS as the market leader in PNH within the first year of launch, expanding our C5 portfolio to make neurology our largest franchise in the U.S., and further diversifying our pipeline with seven business development deals adding five clinical-stage assets to our portfolio," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. (1) Represents contingent milestone payments associated with acquisitions of legal entities accounted for as asset acquisitions. During the three and twelve months ended December 31, 2019, we recognized a net gain of $19.7 million and $32.8 million in investment income, respectively, relating to our Moderna investment. An orphan disease by definition effects 200,000 people or less in the United States. Non-GAAP income tax expense for the twelve months ended December 31, 2019 also excludes certain one-time tax benefits of $95.7 million and $30.3 million associated with a tax election made with respect to intellectual property of Wilson and a release of an existing valuation allowance, respectively, and excludes a one-time tax expense of $10.2 million related to the July 1, 2019 integration of Wilson intellectual property into the Alexion corporate structure. But Alexion gave mixed 2019 guidance, and Alexion stock dipped in reaction. In patients with PNH, aHUS, myasthenia gravis and NMOSD, the complement proteins are over-active and damage the patients’ own cells. (1) In February 2016, the Financial Accounting Standards Board issued a new standard that requires lessees to recognize leases on-balance sheet. The acquisitions were both accounted for as asset acquisitions, as substantially all of the fair value of the gross assets acquired were concentrated in a single asset. A replay of the call will be available for a limited period following the call. (Alexion) During the three and twelve months ended December 31, 2018, we recognized unrealized gains of $57.7 million and $43.1 million, respectively, in investment income to adjust our strategic equity investments to fair value. Non-GAAP income tax expense for the three and twelve months ended December 31, 2018 excludes adjustments to provisional estimates of the impact of Tax Cuts and Jobs Act we recorded in fourth quarter 2017. "I am confident we are well positioned for the future and will build on our momentum in 2020, with a continued focus on delivering long-term shareholder value by advancing our mission of developing and delivering transformative medicines for people with rare diseases.". Alexion’s Ultomiris — The next-gen Soliris. We adopted the new standard on January 1, 2019 using the modified retrospective approach. Table 2014-2019 MEA Soliris Key Players Sales (Tons) List Table 2014-2019 MEA Soliris Key Players Market Share List Table 2014-2024 MEA Soliris Demand (Tons) List by Type Table 2014-2019 MEA Soliris Price (USD/Ton) List by Type Table 2014-2024 Egypt Soliris Market Size (M USD) and Market Volume (Tons) List Soliris (eculizumab) is a member of the selective immunosuppressants drug class and is commonly used for Hemolytic Uremic Syndrome, Myasthenia Gravis, Neuromyelitis Optica, and others. Revenues for 2019 came in at $4.9 billion, up 21% from that in 2018. Alexion disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law. Expanded pipeline with 19 clinical-stage development programs planned for 2020 across 10 assets, including 2 Factor D inhibitors, following completion of Achillion acquisition. Alexion Stock Dips On Patent Worries. By using our website, you agree to our use of cookies in accordance with our, Alexion Reports Fourth Quarter and Full Year 2019 Results. During the nine months ended September 30, 2019, we recorded upfront license payments of $76.3 million in connection with agreements that we entered into with Eidos, Affibody AB and Zealand Pharma A/S. Additionally, during the three and twelve months ended December 31, 2019, we recognized an unrealized gain of $19.3 million and $26.9 million, respectively, in investment income to adjust our remaining strategic equity investments to fair value. TABLE 3: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL GUIDANCE, (in millions, except per share amounts and percentages), Gains and losses related to strategic equity investments, Diluted non-GAAP earnings per common share, Operating expense and margin (% total revenues), Non-GAAP research and development expense, GAAP selling, general and administrative expense, Non-GAAP selling, general and administrative expense, Income tax expense (% of income before income taxes), Tax effect of pre-tax adjustments to GAAP net income. In 2019 the drug generated $3.95 billion in sales, which made up the majority of Alexion’s $4.99 billion 2019 revenue haul. To participate in the call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 3571658 shortly before 7:30 a.m. Eastern Time. (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: (2) During the three months ended September 30, 2019, we recorded an upfront license payment of $30.1 million in connection with an agreement that we entered into with Eidos Therapeutics, Inc. (Eidos). The non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business. The nine months ended September 30, 2018 included the recognition of an unrealized gain of $100.8 million on our investment in Moderna Therapeutics, Inc. following the completion of a new round of equity financing in the first quarter 2018. This press release does not constitute an offer of any securities for sale … The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $45.1 million, inclusive of hedging activities. Soliris is an important drug for Alexion. 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. It is also by far the highest revenue-generating agent in Alexion’s drug portfolio. 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. Continued strong SOLIRIS gMG and NMOSD launches, making neurology largest franchise in U.S. (5) During the three and nine months ended September 30, 2019, we recognized an unrealized gain of $12.0 million and $20.6 million, respectively, in investment income to adjust our strategic equity investments to fair value. Fourth Quarter 2019 Financial Highlights. Upon adoption of the new lease standard, we derecognized $472.8 million of property, plant and equipment and other assets and $372.2 million of facility lease obligations associated with previously existing build-to-suit arrangements which resulted in a decrease of $90.3 million to retained earnings, net of tax. 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). Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. In October 2019, the Board of Directors approved a new share repurchase authorization of $1 billion. The repurchase program does not have an expiration date and we are not obligated to acquire a particular number of shares of common stock. (4) Changes in the fair value of contingent consideration expense for the three and twelve months ended December 31, 2019 as well as the three months ended December 31, 2018 include the impact of changes in the expected timing of achieving contingent milestones, in addition to the interest component related to the passage of time. SOLIRIS ® (eculizumab) net product sales were $990.5 million, compared to $888.0 million in the third quarter of 2018, representing a 12 percent increase. 2020 financial guidance assumes a GAAP effective tax rate of 15.5 to 16.5 percent and a non-GAAP effective tax rate of 16.0 to 17.0 percent for the year. Total revenues in the third quarter were $1,263.1 million, a 23 percent increase compared to the same period in 2018. Alexion is increasing revenues and EPS guidance. Megan Goulart, 857-338-8634 Soliris is Alexion's only source of revenue, so a March warning letter from the FDA detailing some problems at the Rhode Island plant where the drug … The audio webcast can be accessed on the Investor page of Alexion’s website at: http://ir.alexion.com. In addition, we capitalized $326.1 million and $255.3 million of right of use assets and lease liabilities, respectively, within our condensed consolidated balance sheet upon adoption. SOLIRIS volume increased 11 percent year-over-year. Sales of Alexion's Soliris/Ultomiris franchise are expected to climb 17% year over year to a whopping $5 billion in 2020. Soliris is a pharmaceutical used to treat an orphan disease, atypical hemolytic-uremic syndrome (aHUS). Alexion estimates combined Soliris and Ultomiris sales will be around $4 billion for 2019. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Related Links October 2019 … Alexion disclaims any obligation 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, we capitalized $326.1 million and $255.3 million of right of use assets and lease liabilities, respectively, within our condensed consolidated balance sheet upon adoption. Alexion earnings and evenue also topped expectations as Soliris sales spiked. The company also has offices around the globe and serves patients in more than 50 countries. ... third-quarter Soliris sales rose 12% to an annualized $4.0 billion. (3) During the second and fourth quarters of 2018, we completed the acquisitions of Wilson Therapeutics AB (Wilson) and Syntimmune, Inc. (Syntimmune), respectively. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $13.1 million, inclusive of hedging activities. Please refer to the attached Reconciliations of GAAP to non-GAAP Financial Results and GAAP to non-GAAP 2019 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 September 30, 2019 and 2018 and projected twelve months ending December 31, 2019. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). In February 2019, the FDA granted priority review for Soliris in neuromyelitis optica spectrum disorder (NMOSD), setting a PDUFA action date of June 28 2019. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. The audio webcast can be accessed on the Investor page of Alexion’s website at: http://ir.alexion.com. Alexion will host a conference call/audio webcast to discuss the third quarter 2019 results today at 8:00 a.m. Eastern Time. (7) Alexion's non-GAAP income tax expense for the three and twelve months ended December 31, 2019 and 2018 excludes the tax effect of pre-tax adjustments to GAAP profit. Despite the threat to sales of Soliris represented by Selexis and Generium, Alexion is continuing to develop the product. Alexion climbs on strong Soliris sales forecast. (3) In connection with the agreement of the final working capital adjustment for the Syntimmune acquisition, we recognized a benefit of $4.1 million associated with previously acquired in-process research and development in the second quarter of 2019. (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: (2) During the three months ended December 31, 2019, we recorded expense of $27.1 million in connection with upfront payments on strategic agreements that we entered into with Stealth BioTherapeutics Corp. (Stealth) and Immune Pharmaceuticals (Immune Pharma). In conjunction with this amendment, we recognized a gain of $32.0 million in other income and (expense), which reflects an increase in the fair value of the option, less incremental upfront funding and the change in the fair value of contingent payments which we also modified as part of the amendment. "We also continued to expand our portfolio with two additional approvals - ULTOMIRIS for atypical HUS in the U.S. and SOLIRIS for NMOSD in the EU - and three new business development transactions that further diversify our pipeline, including an agreement to acquire Achillion. Net product sales were $1,384.2 million in the fourth quarter of 2019, compared to $1,128.5 million in the fourth quarter of 2018. The September 30, 2019 condensed consolidated balance sheet is presented under the new standard, while the December 31, 2018 condensed consolidated balance sheet is not adjusted and continues to be reported under the accounting standards in effect for that period. This press release contains forward-looking statements, including statements related to: guidance regarding anticipated financial results for 2019 (and the assumptions related to such guidance); the strength of our business and continued growth; plans to expand the Company's pipeline; Company's goal of continuing to build on momentum as the year progresses; future plans for, and the timing for, the commencement of future clinical trials and the expected timing of the receipt of results of certain clinical trials and studies, including clinical programs for ULTOMIRIS in aHUS, NMOSD, HSCT-TMA, ALS, PPMS and a subcutaneous administration in PNH and aHUS and for ALXN1830 in WAIHA and gMG; potential benefits of current products and products under development and in clinical trials; plans for development programs with third parties including, Eidos, Affibody, Dicerna, Zealand, Stealth and Complement Pharma; the potential to treat a broad range of complement mediated diseases with the product to be developed with Zealand; the anticipated closings of the Achillion acquisition and the Immune Pharma asset acquisition; and Alexion's future clinical, regulatory, and commercial plans for ULTOMIRIS and other products and product candidates. (4) Changes in the fair value of contingent consideration expense for the three and nine months ended September 30, 2019 include the impact of changes in the expected timing of achieving contingent milestones, in addition to the interest component related to the passage of time. Non-GAAP diluted EPS for the fourth quarter of 2019 was $2.71, a 27 percent increase versus the fourth quarter of 2018. Vice President, Investor Relations, We use cookies to give you the best online experience. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second anti-FcRn therapy, a second oral Factor D inhibitor and a third complement inhibitor. "In 2019, we continued to strengthen the foundation of our business by executing on our strategy to lead, expand and diversify. SOLIRIS can cause serious side effects including serious infusion-related reactions. Updated 2019 financial guidance assumes a GAAP effective tax rate of 5 to 6 percent and a non-GAAP effective tax rate of 13 to 14 percent for the year. The December 31, 2019 condensed consolidated balance sheet is presented under the new standard, while the December 31, 2018 condensed consolidated balance sheet is not adjusted and continues to be reported under the accounting standards in effect for that period. In the beginning, Soliris was the only approved drug for two rare conditions . Alexion’s Soliris costs about $500,000 per patient, per year, making it one of the most costly medicines. The non-GAAP results, determined in accordance with our internal policies, exclude the impact of the following GAAP items (see reconciliation tables below for additional information): 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 other strategic agreements, acquired in-process research and development, impairment of purchased intangible assets, gains and losses related to strategic equity investments, litigation charges, gain or loss on sale of a business or asset, gain or loss related to purchase options, contingent milestone payments associated with acquisitions of legal entities accounted for as asset acquisitions, acquisition-related costs and certain adjustments to income tax expense. In the same quarter, Amgen raised the lower end of its fiscal 2019 revenue guidance. TABLE 5: CONDENSED CONSOLIDATED BALANCE SHEETS, Prepaid expenses and other current assets (1), Current portion of contingent consideration, Total liabilities and stockholders' equity. The Medicare Part B Drug and Biological Average Sales Price Quarterly Payment files for calendar year 2019 are located in the "Downloads" section below. SOLIRIS net product sales were $975.5 million, compared to $980.8 million in the second quarter of 2019. 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). SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. ULTOMIRIS net product sales were $251.1 million, compared to $54.2 million in the second quarter of 2019, representing a 363 percent increase. 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 other strategic agreements, intangible asset impairments, litigation charges, changes in fair value of contingent consideration, gains or losses related to strategic equity investments or restructuring and related activity outside of the previously announced activities that may occur after the issuance of this press release. The 2020 GAAP and non-GAAP tax rates do not benefit from one-time events that benefited the tax rates in 2019. TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS, Acquired in-process research and development, Amortization of purchased intangible assets, Change in fair value of contingent consideration, Shares used in computing earnings per common share, TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS, Upfront payments related to licenses and collaborations (2). Upon adoption of the new lease standard, we derecognized $472.8 million of property, plant and equipment and other assets and $372.2 million of facility lease obligations associated with previously existing build-to-suit arrangements which resulted in a decrease of $90.3 million to retained earnings, net of tax. 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. In connection with the agreement of the final working capital adjustment for the Syntimmune acquisition, we recognized a benefit of $4.1 million associated with previously acquired in-process research and development in the second quarter of 2019. Alexion compares favorably to most peers over the near-term (2019-2024) and unfavorably in long-term (2024-2029) revenue growth rates. (6) In December 2019, we amended the terms of our agreement with Caelum Biosciences (Caelum) with respect to the option to acquire the remaining equity in Caelum. Selling, general and administrative expense: Acquired in-process research and development (3), Change in fair value of contingent consideration (4), (Gains) and losses related to strategic equity investments (5), GAAP earnings (loss) per common share - diluted, Non-GAAP earnings per common share - diluted, Shares used in computing diluted earnings (loss) per common share (GAAP), Shares used in computing diluted earnings per common share (non-GAAP).

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