soliris sales 2019

Soliris Prices The cost for Soliris intravenous solution (10 mg/mL) is around $6,820 for a supply of 30 milliliters, depending on the pharmacy you visit. Under the Soliris REMS, prescribers must enroll in the program (5.2). On a GAAP basis, diluted EPS in the quarter was $4.00, inclusive of one-time tax benefits related to intra-entity asset transfers of intellectual property, compared to $(0.20) in the prior year, inclusive of $379.3 million of expense related to the value of the in-process research and development asset acquired in connection with our acquisition of Syntimmune in the fourth quarter of 2018. Alexion’s growth has been predominantly dependent on Soliris, as the drug represented 79% of 2019 total net product sales. The repurchase program does not have an expiration date and we are not obligated to acquire a particular number of shares of common stock. In the beginning, Soliris was the only approved drug for two rare conditions . By continuing to deliver on the ambitious transformation plan we laid out two-and-a-half years ago, we have successfully established a strong foundation for the future and look forward to building on this progress as we advance our mission of delivering life-changing therapies to people with rare diseases.". An orphan disease by definition effects 200,000 people or less in the United States. SOLIRIS net product sales were $1,013.1 million, compared to $976.7 million in the fourth quarter of 2018, representing a … (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. It brought in $981 million from Soliris sales in the second quarter of the year, according to financial records.. BOSTON--(BUSINESS WIRE)--Jan. 30, 2020-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the fourth quarter and full year of 2019. Soliris is an important drug for Alexion. (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. Billions of dollars in sales can evaporate overnight as drug patents expire and competitors enter the market. 1 INDICATIONS AND USAGE We adopted the new standard on January 1, 2019 using the modified retrospective approach. A replay of the call will be available for a limited period following the call. It is also by far the highest revenue-generating agent in Alexion’s drug portfolio. 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 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. (1) In February 2016, the Financial Accounting Standards Board issued a new standard that requires lessees to recognize leases on-balance sheet. Alexion is increasing revenues and EPS guidance. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $45.1 million, inclusive of hedging activities. (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). Read full article. 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. Although the patient population intended for Ultomiris, a … 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). For the three and nine months ended September 30, 2018, changes 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. Alexion is in the midst of a patent battle over Soliris, which is responsible for around 80 percent of the company’s revenue, bringing in $981 million in sales in the second quarter of 2019 alone. This website is intended only for residents of the United States. 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. 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. By using our website, you agree to our use of cookies in accordance with our, Alexion Reports Fourth Quarter and Full Year 2019 Results. (Alexion) Alexion estimates combined Soliris and Ultomiris sales will be around $4 billion for 2019. (5) On December 9, 2019, we sold our Moderna Therapeutics Inc. strategic equity investment. This press release contains forward-looking statements, including statements related to: guidance regarding anticipated financial results for 2020 (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, PNH, gMG, PPMS, a subcutaneous administration in PNH and aHUS, a higher concentration formulation of ULTOMIRIS, SOLIRIS in NMOSD and gMG, ALXN1840 in Wilson Disease, CAEL-101 in light chain (AL) amyloidosis, AG10 in ATTR-PN, danicopan in C3G and PNH patients with EVH, ACH-5228 for PNH 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, and Complement Pharma; the potential to treat a broad range of complement mediated diseases with the products to be developed with Zealand and Dicerna and the potential advantages of novel peptide therapies; the potential for the anti-eotaxin-1 antibody from Immune Pharma to treat inflammatory diseases; the potential for CP010 to treat multiple neurological disorders; and Alexion's future clinical, regulatory, and commercial plans for ULTOMIRIS and other products and product candidates. 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. 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 (loss) per common share, TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS, Upfront payments related to licenses and other strategic agreements (2). 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. Soliris sales came in at $3.9 billion.” Clearly, Soliris’ sales represent the bulk of Alexion’s current revenues, which is why the agreement with Amgen was so important. 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). 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. Non-GAAP diluted EPS for the full year of 2019 was $10.53, a 33 percent increase versus the prior year. This website is intended only for residents of the United States. Our teams continued to demonstrate launch excellence across the globe, with very rapid starts to the German and Japanese ULTOMIRIS PNH launches, where conversion is progressing ahead of the best-in-class U.S. launch at the same time points, as well as a strong start to the SOLIRIS NMOSD launch in the U.S.," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. The 2020 GAAP and non-GAAP tax rates do not benefit from one-time events that benefited the tax rates in 2019. 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. 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. (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. SOLIRIS can cause serious side effects including serious infusion-related reactions. 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. "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.". Total revenues in the fourth quarter were $1,384.3 million, a 23 percent increase compared to the same period in 2018. (6) Alexion's non-GAAP income tax expense for the three and nine months ended September 30, 2019 and 2018 excludes the tax effect of pre-tax adjustments to GAAP profit. The company also told Leerink it expects 10% of its business to be at risk to initial biosimilar competition in 2022 to 2023, a lower figure than what the investment bank had forecast. Revenues for 2019 came in at $4.9 billion, up 21% from that in 2018. 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. Vice President, Investor Relations, We use cookies to give you the best online experience. The company's 2019 financial guidance is also being provided on both a reported and a non-GAAP basis. Non-GAAP diluted EPS for the third quarter of 2019 was $2.79, a 38 percent increase versus the third quarter of 2018. (3) During the second and fourth quarters of 2018, we completed the acquisitions of Wilson Therapeutics AB (Wilson) and Syntimmune, Inc. (Syntimmune), respectively. 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. SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. 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. Alexion climbs on strong Soliris sales forecast. 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 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. The value of the acquired in-process research and development assets was expensed during the quarters the acquisitions were completed due to the stage of development of the assets. 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. Alexion’s Ultomiris — The next-gen Soliris. 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); our ability to facilitate the timely conversion of from SOLIRIS to ULTOMIRIS; payer, physician and patient acceptance of ULTOMIRIS as an alternative to SOLIRIS; appropriate pricing for ULTOMIRIS; future competition from biosimilars and novel 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 FDA and other regulatory agencies; results in early stage clinical trials may not be indicative of full results or results from later stage or larger clinical trials (or broader patient populations) and do not ensure regulatory approval; the possibility that results of clinical trials are not predictive of safety and efficacy and potency of our products (or we fail to adequately operate or manage our clinical trials) which could cause us to halt trials, delay or prevent us from making regulatory approval filings or result in denial of approval of our product candidates; unexpected delays in clinical trials; unexpected concerns that may arise from additional data or analysis obtained during clinical trials; future product improvements may not be realized due to expense or feasibility or other factors; uncertainty of long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; inability to complete planned acquisitions due to failure of regulatory approval or material changes in target or otherwise; inability to complete acquisitions and investments due to increased competition for technology; the possibility that current rates of adoption of our products are not sustained; the adequacy of our pharmacovigilance and drug safety reporting processes; failure to protect and enforce our data, intellectual property and proprietary rights and the risks and uncertainties relating to intellectual property claims, lawsuits and challenges against us (including intellectual property lawsuits relating to ULTOMIRIS brought by third parties against Alexion and inter partes review petitions submitted by third parties); the risk that third party payors (including governmental agencies) will not reimburse or continue to reimburse for the use of our products at acceptable rates or at all; failure to realize the benefits and potential of investments, collaborations, licenses and acquisitions; the possibility that expected tax benefits will not be realized; assessment of impact of recent accounting pronouncements; potential declines in sovereign credit ratings or sovereign defaults in countries where we sell our products; delay of collection or reduction in reimbursement due to adverse economic conditions or changes in government and private insurer regulations and approaches to reimbursement; uncertainties surrounding legal proceedings, company investigations and government investigations, including investigations of Alexion by the U.S. Securities and Exchange Commission (SEC) and U.S. Department of Justice; the risk that estimates regarding the number of patients with PNH, aHUS, gMG, NMOSD, HPP and LAL-D and other future indications we are pursuing are inaccurate; the risks of changing foreign exchange rates; risks relating to the potential effects of the Company's restructuring; risks related to the acquisition of companies and co-development and collaboration efforts; and a variety of other risks set forth from time to time in Alexion's filings with the SEC, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended September 30, 2019 and in our other filings with the SEC. (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). 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 company also has offices around the globe and serves patients in more than 50 countries. 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. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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. It now expects its fiscal 2019 revenue to be $22.4 billion–$22.9 billion. Alexion Stock Dips On Patent Worries. "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. View source version on businesswire.com: https://www.businesswire.com/news/home/20200130005195/en/, Media View source version on businesswire.com: https://www.businesswire.com/news/home/20191023005211/en/, Alexion: Media 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. This press release and further information about Alexion can be found at: www.alexion.com. BOSTON--(BUSINESS WIRE)--Oct. 23, 2019-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the third quarter of 2019. Non-GAAP income tax expense for the three and nine months ended September 30, 2019 excludes a one-time tax expense of $10.2 million related to the July 1, 2019 integration of Wilson Therapeutics intellectual property into the Alexion corporate structure. 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. 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. ... third-quarter Soliris sales rose 12% to an annualized $4.0 billion. Total revenues in the third quarter were $1,263.1 million, a 23 percent increase compared to the same period in 2018.

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