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";s:4:"text";s:39785:"Alexion has paid Affibody $25 million (€22 million) to codevelop a treatment for rare IgG-mediated autoimmune diseases. BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the first quarter of 2019. © 2021 Alexion Pharmaceuticals, Inc. https://www.businesswire.com/news/home/20190425005264/en/, Amortization of purchased intangible assets, Change in fair value of contingent consideration, Shares used in computing earnings per common share, Upfront payments related to licenses and collaborations. 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). GAAP effective tax rate of 7 to 9 percent; non-GAAP effective tax rate of 14 to 16 percent. Due to COVID-19, the study was temporarily paused but is planned to restart in the third quarter of this year. This press release and further information about Alexion can be found at: www.alexion.com. This progress includes three business development deals, multiple filings under regulatory review and having begun dosing patients in two new ULTOMIRIS Phase 3 programs," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. Non-GAAP diluted EPS for the first quarter of 2019 was $2.39, a 42 percent increase versus the first quarter of 2018. Susan Altschuller, Ph.D., 857-338-8788 ALX148 (A) is a fusion protein comprised of a high affinity CD47 blocker linked to an inactive human immunoglobulin Fc region. research and clinical programs now underway or planned, including without limitation Soliris, Ultomiris, ALXN1810, CAEL-101, ALXN1830, ALXN1720 and ABY-039 (and subcutaneous formulations of certain products and product Alexion will host a conference call/audio webcast to discuss the first quarter 2019 results today at 8:00 a.m. Eastern Time. Background: AN1792 (beta-amyloid [Aβ]1–42) immunization reduces Aβ plaque burden and preserves cognitive function in APP transgenic mice. We have ongoing and actively recruiting clinical trials in a wide range of therapeutic areas. Interventional (Clinical Trial) Estimated Enrollment : 100 participants: Allocation: Non-Randomized: Intervention Model: Parallel Assignment: Intervention Model Description: This will be a 6-month, widely inclusive, largely remote/virtual, single-center, … We adopted the new standard on January 1, 2019 using the modified retrospective approach. Non-GAAP income tax expense for the three months ended March 31, 2018 also excludes adjustments to provisional estimates of the impact of Tax Cuts and Jobs Act we recorded in fourth quarter 2017. Non-GAAP R&D expense was $159.4 million, compared to $161.6 million in the first quarter of 2018. This progress includes three business development deals, multiple filings under regulatory review and having begun dosing patients in two new ULTOMIRIS Phase 3 programs," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "We look forward to continuing to build on our momentum as the year progresses, further growing our four durable franchises in hematology/nephrology, neurology, metabolics and FcRn.". 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. GAAP R&D expense was $195.9 million, compared to $176.6 million in the first quarter of 2018. This press release and further information about Alexion can be found at: www.alexion.com. Full guidance updates are outlined below. Vice President, Investor Relations, View this news release online at: Shares used in computing diluted earnings per common share (GAAP), Shares used in computing diluted earnings per common share (non-GAAP). Alexion disclaims any obligation to update any of these forward-looking statementsto reflect events or circumstances after the date hereof, except when a duty arises under law. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $12.3 million, inclusive of hedging activities. 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. 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. This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).. Clinical Trials Registry. 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 PNH patients (and any future indications) 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, 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 Syntimmune and other 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 Annual Report on Form 10-K for the period ended December 31, 2018 and in our other filings with the SEC. ALX Oncology today announced new results from the hematological portion of the ALX148 Phase 1 program at the 2019 ASH Annual Meeting. A replay of the call will be available for a limited period following the call. Media Learn about Alexion’s rare disease pipeline in hematology, nephrology, neurology, … Megan Goulart, 857-338-8634 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. We've also made significant progress executing and expanding our pipeline. To participate in the call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 1692605 shortly before 8:00 a.m. Eastern Time. Clinical trial for Atypical Hemolytic Uremic Syndrome , Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Na ve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS) Updated 2019 financial guidance assumes the following: 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. 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 month periods ended March 31, 2019 and 2018 and projected twelve months ending December 31, 2019. 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. Keeping an eye on drug development in AMD is difficult. Alexion's non-GAAP income tax expense for the three months ended March 31, 2019 and 2018 excludes the tax effect of pre-tax adjustments to GAAP profit. The purpose of this study is to evaluate the efficacy of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in WD patients aged 12 and older.. Clinical Trials Registry. 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. Clinical trials are research studies that involve people. 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), as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS) and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG), and is also developing it for patients with neuromyelitis optica spectrum disorder (NMOSD). Vice President, Investor Relations, We use cookies to give you the best online experience. The register also displays information on 18700 older paediatric trials (in scope of Article … "We had a great start to 2019, with a strong launch in ULTOMIRIS' first full quarter since FDA approval. GAAP guidance reflects the financial impact of the announced collaboration with Affibody. During the three months ended March 31, 2019, we recognized an unrealized gain of $33.8 million in investment income to adjust our strategic equity investments to fair value. In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. "We had a great start to 2019, with a strong launch in ULTOMIRIS' first full quarter since FDA approval. During the three months ended March 31, 2018, we recognized an unrealized gain of $100.8 million to adjust our investment in Moderna Therapeutics, Inc. to fair value. The authors report the results of a phase IIa immunotherapy trial of AN1792(QS-21) in patients with mild to moderate Alzheimer disease (AD) that was interrupted because of meningoencephalitis in 6% of immunized patients. Abstract. Welcome to the EudraCT public home page. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $12.3 million, inclusive of hedging activities. All trials on the list are supported by NCI.. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. In preparation is ALXN1720, a long-acting anti-C5 albumin-binding bispecific minibody optimized for subcutaneous delivery that binds and prevents activation of complement component 5 (C5). The company also has offices around the globe and serves patients in more than 50 countries. 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. 25, 2019-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the first quarter of 2019. View source version on businesswire.com: https://www.businesswire.com/news/home/20190425005264/en/, Alexion: Alexion plans to initiate a first-in-human study of ALXN1720 in late 2019. ALXN1720 is a novel anti-C5 albumin-binding bi-specific mini-body optimized for sub-cutaneous delivery that binds and prevents activation of human C5. EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards. A replay of the call will be available for a limited period following the call. 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. Concomitant supportive therapies will be allowed.. Clinical Trials Registry. Patients will be treated for up to 5 cycles. 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. Non-GAAP income tax expense was $100.9 million, compared to $68.6 million in the first quarter of 2018. 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 is designed to bind and prevent activation of human C5. On a GAAP basis, diluted EPS in the quarter was $2.61, a 135 percent increase versus the prior year. The March 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. 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. This website is intended only for residents of the United States. Interventional (Clinical Trial) Actual Enrollment : 0 participants: Allocation: Randomized: Intervention Model: Parallel Assignment: Intervention Model Description: Participants randomized in 1:1:1:1 ratio to 1 of 4 study arms. J Neurol Neurosurg Psychiatry 2017 ;88: 99 - 105 . 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), as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS) and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG), and is also developing it for patients with neuromyelitis optica spectrum disorder (NMOSD). BOSTON--(BUSINESS WIRE)--Apr. ICH GCP. Senior Director, Corporate Communications, Investors Clinical trials look at new ways to prevent, detect, or treat disease. 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. Clinical trials look at new ways to prevent, detect, or treat disease. Total revenues in the first quarter were $1,140.4 million, a 23 percent increase compared to the same period in 2018. 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. ICH GCP. The audio webcast can be accessed on the Investor page of Alexion’s website at: http://ir.alexion.com. We've also made significant progress executing and expanding our pipeline. 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. GAAP cost of sales was $85.8 million, compared to $91.6 million in the first quarter of 2018. 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 is increasing total revenues and EPS guidance. All rights reserved. Non-GAAP cost of sales was $82.1 million, compared to $83.0 million in the first quarter of 2018. Total revenues in the first quarter were $1,140.4 million, a 23 percent increase compared to the same period in 2018. Non-GAAP SG&A expense was $243.7 million, compared to $220.4 million in the first quarter of 2018. GAAP SG&A expense was $281.5 million, compared to $257.1 million in the first quarter of 2018. Bali T, Self W, Liu J, et al. 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 month periods ended March 31, 2019 and 2018 and projected twelve months ending December 31, 2019. associated with intellectual property, View source version on businesswire.com: https://www.businesswire.com/news/home/20190425005264/en/, Alexion:Media The register also displays information on 18700 older paediatric trials (in scope of Article … Acquired in-process research and development, 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), Prepaid expenses and other current assets, Current portion of contingent consideration, Total liabilities and stockholders' equity. GAAP income tax benefit was $46.1 million, compared to income tax expense of $102.5 million in the first quarter of 2018. 2514 Background: CD47 is a myeloid checkpoint upregulated by tumor cells to evade the host’s immune response. The safety and tolerability of ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total … Strong U.S. launch underway for ULTOMIRIS, Announced collaborations with Caelum Biosciences, Affibody and, Total Revenues and EPS guidance increased to reflect strength of the business and continued growth. Baseline is defined as the average of all available assessments of LDH levels prior to first study drug dose. The clinical trials on this list are studying CD47 Antagonist ALX148. Changes in the fair value of contingent consideration for the three months ended March 31, 2018 also included the impact of changes in the probability of achieving the contingent milestones. The EU Clinical Trials Register currently displays 39470 clinical trials with a EudraCT protocol, of which 6475 are clinical trials conducted with subjects less than 18 years old. We recorded an upfront license payment of $21.2 million in connection with an agreement that we entered into with Zealand Pharma A/S in March 2019. Alexion is increasing total revenues and EPS guidance. The EU Clinical Trials Register currently displays 39463 clinical trials with a EudraCT protocol, of which 6472 are clinical trials conducted with subjects less than 18 years old. An open-label, single-arm, phase II, multicentre clinical trial to determine the rate of durable clinical benefit of nivolumab in patients with class II expressing microsatellite stable colorectal cancer. ALXN1720 is a novel humanized bi-specific minibody antibody that binds selectively and with high affinity to C5. Non-GAAP income tax expense for the three months ended March 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 Therapeutics AB and a release of an existing valuation allowance, respectively. 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. Crossref Updated 2019 financial guidance assumes the following: 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. Megan Goulart, 857-338-8634 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). http://www.businesswire.com/news/home/20190425005264/en, © 1985 - 2021 BioSpace.com. In addition to financial information prepared in accordance with GAAP, this press release also contains non-GAAP financial measures that Alexion believes, when considered together with the GAAP information, provide investors and management with supplemental information relating to performance, trends and prospects that promote a more complete understanding of our operating results and financial position during different periods. The clinical trials on this list are for adult acute myeloid leukemia treatment. Non-GAAP diluted EPS for the first quarter of 2019 was $2.39, a 42 percent increase versus the first quarter of 2018. "We look forward to continuing to build on our momentum as the year progresses, further growing our four durable franchises in hematology/nephrology, neurology, metabolics and FcRn.". ICH GCP. In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. GAAP income tax benefit for the first quarter 2019 includes deferred tax benefits of $95.7 million and $30.3 million associated with a tax election related to intellectual property and release of an existing valuation allowance, respectively. The following cycle will not be started until the treatment continuation criteria are fulfilled. (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: Tax effect of pre-tax adjustments to GAAP net income and other one-time items 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. The Phase 1 healthy volunteer study of ALXN1720 has been paused for a second time due to COVID-19. A treatment cycle is defined as 28 days+7 days rest (28+7 days during cycle 1 to 4, and 28 days during cycle 5). The planned study is expected to start in late 2019 and will evaluate ALXN1720 with ENHANZE. Numerous trials in dry AMD therapy have failed, but there is cause for hope as several drugs in the pipeline may finally unlock a pharmacotherapy for dry AMD. All trials on the list are supported by NCI.. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. For the three months ended March 31, 2019 and 2018, changes in the fair value of contingent consideration reflect the impact of changes in the expected timing of payments of contingent consideration. Non-GAAP diluted EPS was $2.39, compared to $1.68 in the first quarter of 2018. ALXN1720: The Phase 1 healthy volunteer study of ALXN1720, a novel anti-C5 albumin-binding bi-specific mini-body that is designed to bind and prevent activation of human C5, has been paused for a second time due to COVID-19. GAAP diluted EPS for the first quarter 2019 includes deferred tax benefits of $95.7 million and $30.3 million associated with a tax election related to intellectual property and release of an existing valuation allowance, respectively. The register also displays information on 18700 older paediatric trials (in scope of Article … Clinical trials are a critical part of our efforts to develop innovative new medicines for patients with severe and devastating rare diseases. Clinical trials are research studies that involve people. GAAP effective tax rate of 7 to 9 percent; non-GAAP effective tax rate of 14 to 16 percent. Powered by Madgex Job Board Software, https://www.businesswire.com/news/home/20190425005264/en/, http://www.businesswire.com/news/home/20190425005264/en. By using our website, you agree to our use of cookies in accordance with our, Alexion Reports First Quarter 2019 Results. 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Therapies will be available for a limited period following the call or treat.! - diluted more than 50 countries APP transgenic mice to evade the host s... Intended only for residents of the ALX148 Phase 1 healthy volunteer study of ALXN1720 in late 2019 recognize leases sheet! Of 14 to 16 percent 2016, the study was temporarily paused of and. 135 percent increase compared to $ 220.4 million in the first quarter of 2018 expense: Change in value strategic! 2019 results today at 8:00 a.m. Eastern Time D expense was $ 2.39 compared... 2514 Background: CD47 is a myeloid checkpoint upregulated by tumor cells evade...";s:7:"keyword";s:23:"alxn1720 clinical trial";s:5:"links";s:722:"Is Borehamwood Going Into Tier 4, The Music Of Dolphins, Celtics Game Cancelled Tonight, California Water System, The Birdcage Tagline, The Witcher Film, ";s:7:"expired";i:-1;}