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. 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, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. (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 is a breakthrough, potentially lifesaving treatment for two rare blood diseases, affecting about 180 patients in Canada. 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. (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. This website is intended only for residents of the United States. Alexion has been named to the Forbes' list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. 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. It was the first ever treatment for either of these rare, orphan conditions. Alexion Stock Dips On Patent Worries. (1) In February 2016, the Financial Accounting Standards Board issued a new standard that requires lessees to recognize leases on-balance sheet. This website is intended only for residents of the United States. Related Links October 2019 … 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. A replay of the call will be available for a limited period following the call. The non-GAAP results 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 collaborations, acquired in-process research and development assets, impairment of intangible assets, change in value of strategic equity investments, litigation charges, gain or loss on sale of a business or asset and certain adjustments to income tax expense. SOLIRIS ® (eculizumab) net product sales were $962.0 million, compared to $800.1 million in the first quarter of 2018, representing a 20 percent increase. 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. We adopted the new standard on January 1, 2019 using the modified retrospective approach. An orphan disease by definition effects 200,000 people or less in the United States. 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. © 2021 Alexion Pharmaceuticals, Inc. https://www.businesswire.com/news/home/20200130005195/en/. Soliris is a pharmaceutical used to treat an orphan disease, atypical hemolytic-uremic syndrome (aHUS). 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.". Selling, general and administrative expense: Acquired in-process research and development (3), Change in fair value of contingent consideration (4), Change in value of strategic equity investments (5), Non-GAAP earnings per common share - diluted, Shares used in computing diluted earnings per common share (GAAP), Shares used in computing diluted earnings per common share (non-GAAP). "In 2019, we continued to strengthen the foundation of our business by executing on our strategy to lead, expand and diversify. 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. The drug is the source of 80 percent of Alexion's annual revenue. "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.". Despite the threat to sales of Soliris represented by Selexis and Generium, Alexion is continuing to develop the product. We adopted the new standard on January 1, 2019 using the modified retrospective approach. Megan Goulart, 857-338-8634 It now expects its fiscal 2019 revenue to be $22.4 billion–$22.9 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. (1) In February 2016, the Financial Accounting Standards Board issued a new standard that requires lessees to recognize leases on-balance sheet. Eculizumab, sold under the brand name Soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica.In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. (Alexion) It brought in $981 million from Soliris sales in the second quarter of the year, according to financial records.. "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. Senior Director, Corporate CommunicationsInvestors On a GAAP basis, diluted EPS in the quarter was $2.08, a 41 percent increase versus the prior year. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $13.1 million, inclusive of hedging activities. The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body’s defence system called the ‘complement system’.. Non-GAAP diluted EPS for the fourth quarter of 2019 was $2.71, a 27 percent increase versus the fourth quarter of 2018. Alexion estimates combined Soliris and Ultomiris sales will be around $4 billion for 2019. Total revenues in the fourth quarter were $1,384.3 million, a 23 percent increase compared to the same period in 2018. 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). 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. Updated guidance includes the financial impact of the recently announced agreement to acquire Achillion, which closed in January 2020. 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. In the same quarter, Amgen raised the lower end of its fiscal 2019 revenue guidance. 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. 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. 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. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747). Although the patient population intended for Ultomiris, a … (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. 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 medicines. SOLIRIS patent expiration date, news, international patents, biosimilar launch. 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. Total net product sales were $1,140.2 million in the first quarter of 2019, compared to $930.4 million in the first quarter of 2018. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $45.1 million, inclusive of hedging activities. 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). 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. 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) 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). Alexion is increasing revenues and EPS guidance. Alexion’s Ultomiris — The next-gen Soliris. 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 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 the first nine months of 2019, free cash flow grew 7% year over year to $2.4 billion. ... third-quarter Soliris sales rose 12% to an annualized $4.0 billion. 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. 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. Read full article. 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. 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. The audio webcast can be accessed on the Investor page of Alexion’s website at: http://ir.alexion.com. Alexion also uses these non-GAAP financial measures to establish budgets, set operational goals and to evaluate the performance of the business. A replay of the call will be available for a limited period following the call. 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. TABLE 3: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL GUIDANCE, (in millions, except per share amounts and percentages), TABLE 5: CONDENSED CONSOLIDATED BALANCE SHEETS, Prepaid expenses and other current assets (1), Current portion of contingent consideration, Noncurrent operating lease liabilities (1), Total liabilities and stockholders' equity. In the beginning, Soliris was the only approved drug for two rare conditions . 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. "With consistent and strong execution, we have delivered another record performance in the third quarter, building on our momentum from the first half of 2019. Alexion climbs on strong Soliris sales forecast. 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. Vice President, Investor Relations, We use cookies to give you the best online experience. The negative impact of foreign currency on total revenues year-over-year was less than 1 percent, or $2.5 million, inclusive of hedging activities. SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Jun 28, 2019 11:20am. 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). Non-GAAP income tax expense for the three and nine months ended September 30, 2018 excludes adjustments to provisional estimates of the impact of Tax Cuts and Jobs Act we recorded in fourth quarter 2017. In 2011, the FDA approved Soliris to treat atypical hemolytic uremic syndrome (aHUS). During the twelve months ended December 31, 2019, we recorded expense of $103.4 million in connection with upfront payments on strategic agreements that we entered into with Stealth, Immune Pharma, Eidos Therapeutics, Inc., Affibody AB and Zealand Pharma A/S. SOLIRIS net product sales were $1,013.1 million, compared to $976.7 million in the fourth quarter of 2018, representing a … (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). This press release and further information about Alexion can be found at: www.alexion.com. Launched in 2007, the FDA approved Soliris to treat paroxysmal nocturnal hemoglobinuria (PNH). 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 non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business. Full guidance updates are outlined below. 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. Expanded pipeline with 19 clinical-stage development programs planned for 2020 across 10 assets, including 2 Factor D inhibitors, following completion of Achillion acquisition. 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. 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.
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