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ULTOMIRIS - NMOSD: A Phase 3 study of ULTOMIRIS in NMOSD is underway. The contract, which averaged around $456 last year, was at $972 on Thursday.Renovation activity is expected to stay “extremely strong,” according to Brendan Lowney, principal of macroeconomics at FEA. We have also seen initial signs of slowing new patient initiations and delays in treatment starts and will continue to monitor this environment as the pandemic continues. Alexion will host a conference call/audio webcast to discuss the first quarter 2020 results today at 8:00 a.m. Eastern Time. Those who got in early have made tremendous profits. This higher concentration formulation is designed to reduce infusion time by more than 50 percent to approximately 45 minutes. ULTOMIRIS - Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA): Alexion plans to initiate limited dose-ranging studies in the second half of 2020, followed by Phase 3 trials in 2021, pending regulatory feedback. Obviously, that would be bad news for OCGN stock. Even with the $23 million in proceeds from its recent direct offering, Ocugen still doesn’t have the balance sheet to support that lofty number, either. Whether risk-hungry or risk-averse, you should tread carefully with OCGN stock. But that said, while there’s a chance for nimble traders to make some fast gains, this is still a big gamble. Here’s what’s coming. Luc Mathys, head of fixed income in the unit, was also suspended from his role, the person said. If Covaxin Fails, There’s Very Little to Soften the Blow The recently released Phase 3 interim results look promising. During the three months ended March 31, 2020 and March 31, 2019, we recognized unrealized losses (gains) of 9.2 million and $(33.8) million, respectively, in investment income to adjust our strategic equity investments to fair value. BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the second quarter of 2020.Total revenues in the second quarter were $1,444.6 million, a 20 percent increase compared to the same period in 2019. ALXN2040 (Danicopan/ACH-4471) - PNH with Extravascular Hemolysis (EVH): ALXN2040 - C3 Glomerulopathy (C3G): Phase 2 studies of ALXN2040 in C3G is underway. But that rule was yanked by the Trump administration soon after Trump took office in 2017. The indemnity was provided in a letter to Credit Suisse’s Nova Lux fund. Total revenues in the first quarter were $1,444.8 million, a 27 percent increase compared to the same period in 2019. The Trump administration's WHD released guidance letters based on the proposed rule as late as just a few days before President Joe Biden took office. "Any commenter feedback addressing or suggesting such a replacement or otherwise requesting that the department adopt any specific guidance if the rule is withdrawn will be considered to be outside the scope of [the announcement]," the WHD said in its statement. We have also seen initial signs of slowing new patient initiations and delays in treatment starts and will continue to monitor this environment as the pandemic continues. Given the high level of stimulus and savings rates, the country could see “monster retail sales,” as the economy opens up, Fath said. For the three months ended March 31, 2020, we recorded $38.1 million of acquisition-related costs in connection with the Achillion acquisition. Clinical Trials: We are committed to continuing our clinical trials with as little interruption as possible, while also being sensitive to the local dynamics and pressures in many countries and locations where these trials are being conducted. Alexion is continually monitoring the evolving situation and adjusting our operations as needed to support the safety and well-being of our employees and the patients and communities we serve. BOSTON--(BUSINESS WIRE)--Oct. 29, 2020-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the third quarter of 2020. The indirect bid for the 10-year sale, a proxy for international participation as it includes the likes of foreign central banks, was the lowest since August.“I was surprised to hear bullish commentaries on the U.S. Treasury auctions because to me they have showed a clear bearish pattern,” said Althea Spinozzi, a strategist at Saxo Bank A/S, who sees this week as a consolidation before the selloff resumes. BOSTON--(BUSINESS WIRE)-- [CDATA[>*/ Alexion also uses these non-GAAP financial measures to establish budgets, set operational goals and to evaluate the performance of the business. ULTOMIRIS - Atypical Hemolytic Uremic Syndrome (aHUS): In April 2020, Alexion announced a positive opinion for ULTOMIRIS in aHUS from the European Medicines Agency Committee for Medicinal Products for Human Use. China has also increased its appetite for lumber, and FEA forecasts the Asian nation will need to boost imports by around 14%.“There’s not going to be enough fiber to supply global demand for saw timber over the next decade,” Jannke said, adding that only the southern U.S. and Russia have significant amounts of excess timber. The 10-year rate has failed to close above 1.60% since early 2020, though it has surpassed that level in volatile intraday trading several times in recent weeks.“We’re talking about a fair amount of stimulus -- both fiscal and monetary -- going forward,” BTG Pactual Asset Management’s John Fath said, referring to the $1.9 trillion pandemic-relief bill and prospects for more, along with the Federal Reserve’s pledge to stay accommodative. That is the environment that led us to decide we should consider Bitcoin as a treasury reserve asset.”‘Every Scar’Not everyone agrees with the strategy.“Saylor equated Bitcoin to a bank – that’s just ridiculous,” said Marc Lichtenfeld, chief income strategist at the Oxford Club, a financial-research firm that has no stake in MicroStrategy. It reported earnings per share of … 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). Moderna spiked when it began to work on its Covid-19 vaccine. We’re still very early. Alexion Pharmaceuticals, Inc. today announced financial results for the first quarter of 2020. A replay of the call will be available for a limited period following the call. Head of Investor Relations. Alexion Q4 and Full Year 2020 Results. "The reclassification of employees as independent contractors, or the use of independent contracting relationships as opposed to employment, decreases access to employer-provided fringe benefits such as health care or retirement benefits," it said in one section. Total revenues in the first quarter were $1,444.8 million, a 27 percent increase compared to the same period in 2019. More articles by John Kingston New federal rule on worker classification may not see light of day Labor Department tackles employee classification; AB5 may not be affected PRO Act with its ABC test approved in House See more from BenzingaClick here for options trades from BenzingaIncreasingly Difficult Yearly Comps Are A Distraction; The Market Is RollingPPP Money Flowing To Transportation, Warehousing At Same Rate As Before© 2021 Benzinga.com. While the COVID-19 impact varies by study and program, generally, we expect there will be little timing impact on fully-enrolled trials and a timing shift of at least three months on trials that are enrolling patients and activating sites, or have not yet started to do so. The Nasdaq 100 Index gauge slumped after accelerating vaccinations in the U.S. and the passage of the $1.9 trillion pandemic-relief bill sent Treasury yields past 1.64%. TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS, Cost of sales (exclusive of amortization of purchased intangible assets), 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 other strategic agreements (1). Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the first quarter of 2020. “There will be no peace before we get U.S. 10s to 2%.”(Updates throughout. The decision came on the same day as a court in Australia shot down a last-ditch effort by Greensill to force the insurer to provide more coverage. 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 month periods ended March 31, 2020 and 2019 and projected twelve months ending December 31, 2020. For those looking to short it, watch out. “We find it hard to see where this fiber’s going to come from.”(Adds details of industry letter in first three paragraphs. "We had a strong first quarter across our global commercial business, driven by substantial growth in the number of patients we're treating with our medicines. Updated 2020 financial guidance assumes a GAAP effective tax rate of 15.0 to 16.0 percent and a non-GAAP effective tax rate of 15.5 to 16.5 percent. Business Impact: We have taken proactive measures designed to mitigate the risk of potential interruptions in supply and/or access to patients' customary site-of-care locations. Non-GAAP diluted EPS for the first quarter of 2020 was $3.22, a 35 percent increase versus the first quarter of 2019. GAAP income tax expense was $106.0 million, compared to income tax benefit of $46.1 million in the first quarter of 2019. lumber imports will need to increase by roughly 14% to 15% this year, Jannke said. Acquisition-related costs primarily consist of transaction costs, costs associated with the accelerated vesting of stock options previously granted to Achillion employees and restructuring-related costs. Alexion plans to expand the AG10 program into Japan in 2020, pending regulatory feedback. Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the second quarter of 2020. A resurgence of the virus in Italy coupled with division over AstraZeneca Plc’s Covid-19 vaccine also hit sentiment. 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. Timing your 2020 tax return could make all the difference for your stimulus check. As InvestorPlace’s Vince Martin discussed on Mar. ULTOMIRIS - gMG: A Phase 3 study of ULTOMIRIS in adults with gMG is underway. Business Impact: We have taken proactive measures designed to mitigate the risk of potential interruptions in supply and/or access to patients' customary site-of-care locations. ULTOMIRIS - Amyotrophic Lateral Sclerosis (ALS): In March 2020, Alexion began dosing patients in a Phase 3 study of ULTOMIRIS in ALS. While there’s an opportunity here for another short-term spike, this long-shot vaccine play remains very speculative. Study results are expected in the first half of 2021. What happens if Covaxin doesn’t get a green light from the FDA? Bitcoin traded above $60,000 Saturday. Clinical Trials: We are committed to continuing our clinical trials with as little interruption as possible, while also being sensitive to the local dynamics and pressures in many countries and locations where these trials are being conducted. Acquisition-related costs primarily consist of transaction costs, costs associated with the accelerated vesting of stock options previously granted to Achillion employees and restructuring-related costs. The tests include such provisions as the level of control the employer has over the worker and the "degree of permanence" in the job. The Biden administration is not proposing an immediate substitute, which means previous rules are back in effect. Trading for far less than $1 per share for most of 2020, OCGN stock went into hyperdrive starting in late December. Non-GAAP R&D expense was $185.7 million, compared to $159.4 million in the first quarter of 2019. During the three months ended March 31, 2020, we recorded $21.5 million in litigation charges in connection with ongoing investigations. ULTOMIRIS - Renal Diseases: Alexion plans to initiate a proof-of-concept trial of ULTOMIRIS in patients with various renal diseases in 2020. During the three months ended March 31, 2020, we recorded $21.5 million in litigation charges in connection with ongoing investigations. 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. If the acquisition gets all needed regulatory clearances, as well as approvals by the shareholders of both companies, the deal is expected to be finalized in the third quarter of 2021. On Wednesday, Alexion reported revenue for the first quarter of 2020 of $1.4 billion, 27% higher than a year earlier. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. 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. And that’s after pulling back some 46% from its highs set last month. The WHD first announced in February it was considering delaying the rule that was to go into effect in March, then delayed to May and now has withdrawn it. Non-GAAP income tax expense was $141.2 million, compared to $100.9 million in the first quarter of 2019. “They’ve failed to show strong demand from foreign investors, leaving Treasuries prone to volatility as we head into FOMC week, where a 20-year sale and 10-year TIPS auction are going to test the market as well.”The Federal Open Market Committee’s meeting next week is set to be the next major focus point for traders. Michel Degen, head of asset management in Switzerland and EMEA, is being replaced on an interim basis by Filippo Rima, according to a person with knowledge of the matter. Alexion is decreasing total revenues and EPS guidance and increasing non-GAAP operating margin guidance. But as WHD said in a subheadline about the elevation of two of those standards under the economic realities test, "the rule's standard has never been used by any court or by WHD and is not supported by the [FLSA]'s text or case law." Megan Goulart, 857-338-8634 We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means wherever possible. The 2020 GAAP and non-GAAP tax rates do not benefit from one-time events that benefited the tax rates in 2019. During the three months ended March 31, 2019, we recorded expense of $21.2 million in connection with an upfront payment on a strategic agreement that we entered into with Zealand Pharma A/S. Alexion's non-GAAP income tax expense for the three months ended March 31, 2020 and 2019 excludes the tax effect of pre-tax adjustments to GAAP profit. European Medicines Agency Committee for Medicinal Products, https://www.businesswire.com/news/home/20200506005293/en/, Do Not Sell My Personal Information (CA Residents Only), Received positive CHMP opinion for ULTOMIRIS® (ravulizumab) in atypical hemolytic uremic syndrome (aHUS) in the EU, Advanced ULTOMIRIS as standard of care in PNH with more than 67% patient conversion from SOLIRIS® (eculizumab) in, Further diversified development-stage and commercial-stage portfolios with close of Achillion acquisition and announced agreement to acquire Portola, Provided update on COVID-19 related activities and impact. While both stocks have pulled back a bit since then, it’s clear that any sort of progress with Ocugen’s attempts to bring a vaccine to America will result in similar upward moves. 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’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. Yet, further positive news about Covaxin could send it soaring once more. We also made significant progress diversifying our portfolio through business development, with the close of the Achillion acquisition and the announcement that we have entered into an agreement to acquire Portola," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. But most Americans won’t see what’s going on until it’s too late. Net product sales were $6,069.1 million, compared to $4,990.0 million in 2019. Thanks to their dedication, I am confident we will be able to continue executing on our strategy and delivering long-term shareholder value by advancing our mission of developing and delivering transformative medicines.". Thanks to their dedication, I am confident we will be able to continue executing on our strategy and delivering long-term shareholder value by advancing our mission of developing and delivering transformative medicines.". A July 2015 rule further clarified the definition. 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); our expectations regarding the affects COVID-19 will have on our business and operations, including clinical trials and product supply; the strength of our business and continued growth; plans to expand the Company's pipeline; 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, a higher concentration formulation of ULTOMIRIS, SOLIRIS, ALXN1840, CAEL-101, AG10, ALXN2040 and ALXN1830; potential benefits of current products and products under development and in clinical trials; plans for development programs with third parties; and Alexion's future clinical, regulatory, and commercial plans for ULTOMIRIS and other products and product candidates. OCGN Stock Spiked on the Rumor, Could Soar on the News As I discussed back in February, the risk-return of buying Ocugen — as it trades at inflated prices — doesn’t look worth it on the surface. 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. Under the $1.9 trillion relief bill known as the American Rescue Plan, any student debt wiped away through the end of 2025 wouldn’t be counted as income for tax purposes. But, with interim results from its Phase 3 clinical trial showing Covaxin “demonstrates 81% efficacy,” Ocugen may be one step closer to getting it approved in the States. It’s started an internal probe into the collapse of the supply chain finance strategy.The scandal is also raising fresh questions about the firm’s risk management after a series of missteps and Warner’s role after she signed off on a $140 million loan to Greensill in late October, overruling some risk managers, people familiar with the matter said recently. COVID-19 Development Program: We are exploring the potential role of ULTOMIRIS and SOLIRIS for the treatment of severe COVID-19 and have recently initiated a Phase 3 randomized controlled trial of ULTOMIRIS in a subset of adults with COVID-19. And with the disappearance of health care benefits, commenters on the original proposed rule noted that such a shift "increases the prevalence of independent contracting (to) state and federal governments." For the first quarter ended March 31, Alexion earned $3.22 per share on $1.44 billion in sales, up a respective 35% and 27% year over year. So, if Covaxin is a bust, OCGN stock will head fast back towards its prior price levels. Alexion is decreasing total revenues and EPS guidance and increasing non-GAAP operating margin guidance. ALXN1720: Seven of nine cohorts are complete in a Phase 1 healthy volunteer study of ALXN1720, a novel anti-C5 albumin-binding bi-specific mini-body that binds and prevents activation of human C5.
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