The plant is not currently approved by the MHLW in Japan or other regulatory agencies to manufacture Soliris and we will not be capable of manufacturing Soliris for commercial sale in Japan on our own until such time as we have received MHLW approval of our manufacturing facility, if ever. Our clinical and preclinical quantities of other product candidates are produced ARIMF. If we do not maintain our regulatory approvals for Soliris, the value of our company and our results of operations will be materially harmed. See additional discussion below under the headings “Government initiatives that affect coverage and reimbursement of drug products could adversely affect our business” and “The credit and financial market conditions may aggravate certain risks affecting our business.” In addition, certain countries establish pricing and reimbursement amounts by reference to the price of the same or similar products in other countries. Our product liability insurance may not cover all potential types of liabilities or may not cover certain liabilities completely. We have and may in the future obtain patents or the right to practice patents through ownership or license. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement carrying amounts and tax basis of assets and liabilities using enacted tax rates in effect for years in which the temporary differences are expected to reverse. Soliris is a humanized monoclonal antibody that effectively blocks terminal complement activity at the doses currently prescribed. Important risk factors could cause actual future results and other future events to differ materially from those currently estimated by management, including, but not limited to, the risks that: a condition to the closing the proposed acquisition may not be satisfied; a regulatory approval that may be required for the proposed acquisition is delayed, is not obtained or is obtained subject to conditions that are not anticipated; management’s time and attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; the credit ratings of the combined company declines following the proposed acquisition; legal proceedings are instituted against Alexion, AstraZeneca or the combined company; Alexion is unable to retain key personnel; and the announcement or the consummation of the proposed acquisition has a negative effect on the market price of the capital stock of Alexion or on Alexion’s operating results. All obligations of each borrower under the credit facilities, and the guarantees of those obligations, are secured, subject to certain exceptions, by substantially all of each borrower's assets and the assets of certain guarantors, including the pledge of the equity interests of certain of our subsidiaries and real estate located in Smithfield, Rhode Island, but excluding intellectual property and assets of certain foreign subsidiaries. We continue to monitor economic conditions, including volatility associated with international economies, associated impacts on the financial markets and our business, and the sovereign debt crisis in Europe. The FDA authorized our Investigational New Drug Application (IND) for studying the safety and efficacy of eculizumab in treating patients with severe, refractory MG, an ultra-rare autoimmune syndrome characterized by uncontrolled complement activation leading to the failure of neuromuscular transmission. We are subject to environmental laws and potential exposure to environmental liabilities. The credit and economic conditions in Greece, Italy and Spain, among other members of the European Union have deteriorated throughout 2011 and into 2012. We have made preliminary plans for structuring the Enobia legal entities, including a determination of which legal entities will own the acquired assets, which could create a tax liability during 2012. Our clinical programs, including investigator sponsored clinical programs, are as follows: Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), STEC-HUS (Shiga-toxin producing E. Coli Hemolytic Uremic Syndrome), Presensitized Renal Transplant - Living Donor, Dry Age-Related Macular Degeneration (AMD)*. change in operating assets and liabilities primarily relates to: due to the increased number of patients treated with Soliris globally, as well as reimbursement and price approvals in additional territories. Such research partners may be unwilling to grant us exclusive rights to technology or products developed through such collaborations. Under our charter, our board of directors has the authority, without further action by stockholders, to. in research and development payroll and benefit expense related primarily to global expansion of staff supporting our increasing number of clinical and development programs. Also in November 2011, the EC granted marketing authorization for Soliris to treat pediatric and adult patients with aHUS in Europe. TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS, Cost of sales (exclusive of amortization of purchased intangible assets), Acquired in-process research and development, Amortization of purchased intangible assets, Change in fair value of contingent consideration, Shares used in computing earnings per common share, TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS, Fair value adjustment in inventory acquired (1), Upfront payments related to licenses and other strategic agreements (2). In particular, use of C5 Inhibitors, such as Soliris, is associated with an increased risk for certain types of infection, including Meningococcal infection. Outside the United States, our ability to market any of our potential products is dependent upon receiving marketing approvals from the appropriate regulatory authorities. In our opinion, the accompanying unaudited consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of our financial statements for interim periods in accordance with accounting principles generally accepted in the United States. We do not use derivative financial instruments for speculative trading purposes. We cannot assure you that the Enobia, Taligen and Orphatec acquisitions, or any other acquisition or in-licensing of new products, will result in short-term or long-term benefits to us. Unless required by law, we undertake no obligation to update publicly any forward-looking statements, whether because of new information, future events or otherwise. If we cannot raise adequate funds to satisfy our capital requirements, we may have to delay, scale-back or eliminate our research and development activities or future operations. We have made preliminary plans for structuring the Enobia legal entities, including a determination of which legal entities will own the acquired assets, which could create a tax liability during 2012. This increase was also due to increases in payroll and benefits of $2,000 within our general and administrative functions to support our infrastructure growth as a global commercial entity. The United States Foreign Corrupt Practices Act (FCPA) and similar anti-bribery laws in other countries prohibit companies and their representatives from offering, promising, authorizing or making payments to foreign officials for the purpose of obtaining or retaining business. A costly license, or inability to obtain a necessary license, could have a material adverse effect on our business. On May 20, 2011, we effected a two-for-one stock split, paid in the form of a. stock dividend. In February 2012, we completed a business combination of Enobia. The goodwill attributable to our acquisition of Enobia has been recorded as a noncurrent asset and is not amortized, but is subject to an annual review for impairment. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, we accrue a liability for the estimated loss. . Clinical development costs have been accumulated and allocated to each of our programs, while product development and discovery research costs have not been allocated. If any of our patents are narrowed, invalidated or become unenforceable, competitors may develop and market products similar to ours that do not conflict with or infringe our patents rights, which could have a material adverse effect on our financial condition. aHUS is a genetic ultra-rare disease characterized by chronic uncontrolled complement activation and thrombotic microangiopathy, the formation of blood clots in small blood vessels throughout the body, causing a reduction in platelet count (thrombocytopenia) and life-threatening damage to the kidney, brain, heart and other vital organs. Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid. At. Subsequent adjustments for further declines in credit rating are recorded as bad debt expense as a component of selling, general and administrative expense. Until required for use in the business, we may invest our cash reserves in money market funds and high quality commercial, corporate and U.S. government and agency bonds and commercial paper in accordance with our investment policy. We do not provide US taxes on the undistributed earnings of its non-US subsidiaries as these earnings are intended to be permanently reinvested in the businesses offshore. CLL is a type of cancer of the blood and bone marrow. The final amounts and timing could change based on various factors such as finalization of asset valuations and further tax analyzes related to the acquired assets. The term loan facility requires minimum quarterly payments of $12,000 starting in June 2012, and we expect to generate sufficient cash flow from our operations to fund the required principal and interest payments. Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the third quarter of 2020. We agreed to make an upfront payment of $610,000 subject to purchase price adjustments, which resulted in us making an upfront cash payment of, for 100% of Enobia's capital stock. ALXN 1007 is a novel humanized antibody designed to target rare and severe inflammatory disorders and is a product of our proprietary antibody discovery technologies. In this way, asfotase alfa is designed to normalize the genetically defective metabolic process and prevent or reverse the severe, crippling and life-threatening complications of dysregulated mineral metabolism in patients with HPP. This hierarchy prioritizes the inputs into three broad levels as follows. We sell Soliris to a limited number of customers, and we evaluate the creditworthiness of each such customer on a regular basis. The range of estimated milestone payments is from, if no clinical milestones are achieved for any product to. We record distribution and other fees paid to our customers as a reduction of revenue, unless we receive an identifiable and separate benefit for the consideration and we can reasonably estimate the fair value of the benefit received. We could decide to abandon development or be required to spend considerable resources not otherwise contemplated. Alexion Pharmaceuticals, Inc. (“Alexion”, the “Company”, “we”, “our” or “us”) is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. In addition, the future success of such transactions would depend in part on our ability to manage the rapid growth associated with any such acquisitions or in-licensing. In addition to the upfront payments, the purchase agreements for the Enobia, Taligen and Orphatec acquisitions also include contingent payments totaling up to $470,000, $367,000 and $42,000, respectively, if and when certain development and. We may also use the facilities for working capital requirements, acquisitions and other general corporate purposes. We recognize investment income primarily from our portfolio of cash equivalents and marketable securities. Further, we have limited experience manufacturing the drug candidates that we acquired from Enobia, Taligen and Orphatec, such as asfotase alfa. Alexion Pharmaceuticals, Inc.(ALXN Quick Quote ALXN - Free Report) is scheduled to release fourth-quarter 2020 results on Feb 4, before market open.The company has … Because we are a Delaware corporation, the anti-takeover provisions of Delaware law could make it more difficult for a third party to acquire control of us, even if the change in control would be beneficial to stockholders. Although a number of specialty distributors and specialty pharmacies, which supply physician office clinics, hospital outpatient clinics, infusion clinics, home health care providers, and governmental organizations, distribute Soliris, they generally carry a very limited inventory and may be reluctant to distribute Soliris in the future if demand for the product does not increase. We are exposed to fluctuations in foreign currency exchange rates in the normal course of our business. Even if we are able to find alternatives they may ultimately be insufficient for our needs. The loss of his services could materially and adversely affect our ability to achieve our objectives. Any of these results could decrease or prevent any sales of Soliris or substantially increase the costs and expenses of commercializing and marketing Soliris. Although we have evaluated these government initiatives and the impact on our business, we cannot know with certainty whether any such law, rule or regulation. Natural disasters, acts of war or terrorism, shipping embargos, labor unrest or political instability, could adversely affect our operations, including our ability to supply and commercialize Soliris. The E.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that: Title 17 of the Code of Federal Regulations. We continue to maintain a valuation allowance against certain other deferred tax assets where realization is not certain. However, we will not be capable of manufacturing Soliris at ARIMF for commercial sale in Japan or other territories until such time as we have received the required regulatory approval for our facility, if ever. The approval process varies from country to country and the requirements governing the conduct of clinical trials, product manufacturing, product licensing, pricing and reimbursement vary greatly from country to country. Gains and losses on these hedge transactions are designed to offset gains and losses on underlying balance sheet exposures. In those circumstances, we would not be able to obtain regulatory approval in such country on a timely basis, if ever. We expect that cash generated from operations will be sufficient to meet debt service obligations. In the ordinary course of our business, we collect and store sensitive data, including intellectual property, our proprietary business information and that of our suppliers, customers and business partners, and personally identifiable information. Revenue is recorded upon receipt of the product by the end customer, which is typically a hospital, physician’s office, private or government pharmacy or other health care facility. If it is finally determined that we infringe the Novartis patent, we may be required to pay royalties to Novartis on sales of Soliris regarding certain manufacturing technology. The following table summarizes the calculation of basic and diluted EPS for the three months ended. We must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. These costs relate to efforts on our clinical and preclinical products, our product development and our discovery research efforts. * Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections. If Soliris fails to achieve or maintain market acceptance among the medical community or patients in a particular country, we may not be able to market and sell it successfully in such country, which would limit our ability to generate revenue and could harm our overall business. At, , two individual customers accounted for 18% and 11% of the accounts receivable balance. The requirements governing drug pricing vary widely from country to country, and we cannot guarantee that we will have the capabilities or resources to successfully conclude the necessary processes and commercialize Soliris in every or even most countries in which we seek to sell Soliris. We manage our foreign currency transaction risk within specified guidelines through the use of derivatives. Such obligations and liabilities, which to date have not been material, could have a material impact on our business and financial condition. As of, under the revolving credit facility, and we had open letters of credit of, Our borrowing availability was approximately. Executive Director, Corporate Communications, Investors For example, the governments of Germany and Spain each approved increases to mandatory rebates on the sales of pharmaceutical products. (Gains) and losses related to strategic equity investments include unrealized gains and losses in investment income to adjust our strategic equity investments to fair value. We are authorized to sell product that is manufactured in our facility in the United States, the European Union and certain other territories. We may expand our business through acquisitions or in-licensing opportunities that could disrupt our business and harm our financial condition. We depend on a very limited number of third party providers for other services with respect to our clinical and commercial requirements, including product finishing, packaging, vialing and labeling. (eculizumab) is the first and only therapeutic approved for patients with two ultra-rare and severe disorders resulting from chronic uncontrolled activation of the complement component of the immune system: paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare and life-threatening blood disorder, and atypical hemolytic uremic syndrome (aHUS), an ultra-rare and life-threatening genetic disease. Changes in pricing or the amount of reimbursement in countries where we currently commercialize Soliris may also reduce our profitability and worsen our financial condition. Cost of sales as a percentage of net revenue was. The new standard allows companies an option to first assess qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis for determining if it is necessary to perform the two-step quantitative goodwill impairment test. Although we do not believe that the manufacture of Soliris infringes a valid patent claim owned by Novartis, we cannot guarantee that we will be successful in defending against such action. On January 28, 2011, we acquired all of the outstanding capital stock of Taligen Therapeutics, Inc. (Taligen) in a transaction accounted for under the acquisition method of accounting for business combinations. In addition, our business requires using sensitive technology, techniques and proprietary compounds that we protect as trade secrets. We can provide no assurance that we will be able to manufacture our drug products at ARIMF under conditions required by the FDA or foreign regulatory agencies on a timely basis, if at all. of a gain recognized in accumulated other comprehensive income is expected to be reclassified to revenue over the next 12 months. Beginning in 2013, the Sunshine provisions require manufacturers to publicly report gifts and payments made to physicians and teaching hospitals. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. , respectively, associated with the foreign exchange contracts not designated as hedging instruments under the guidance. Regulatory authorities must approve the facilities in which our products are manufactured vialed, packaged and labeled prior to granting marketing approval for any product candidate. complications shown to be due to rapid destruction of a larger number of PNH red blood cells; however, we have not studied the delay or termination of treatment in enough patients to determine that such complications in the future are unlikely to occur. The following table provides information regarding research and development expenses: in research and development expense, as compared to the same period in the prior year, was primarily related to the following: in external clinical development expenses related primarily to an expansion of studies of eculizumab for non-PNH indications and studies of HPP associated with our acquisition of Enobia (see table below). This is due to several factors, including general market conditions, sales of Soliris, the announcement of the results of our clinical trials or product development and the results of our efforts to obtain regulatory approval for our products. For a complete discussion of these critical accounting policies, refer to “Critical Accounting Policies and Use of Estimates” within “Item 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations” included within our Form 10-K for the year ended December 31, 2011. Although we believe we can find alternative distributors on a relatively short notice, our revenue during that period of time may suffer and we may incur additional costs to replace a distributor. If our trade secrets were exposed, it would help our competitors and adversely affect our business prospects. Soliris and many of our product candidates are genetically engineered antibodies, including recombinant humanized antibodies, recombinant human antibodies, or recombinant human single chain antibodies. will adversely affect coverage and reimbursement of Soliris, or to what extent, until such laws, rules and regulations are promulgated, implemented and enforced. Product development costs are those incurred in performing duties related to manufacturing development and regulatory functions. We incurred significant debt to finance the acquisition of Enobia and we will have substantial expenses as we continue our research and development efforts, integrate the programs we acquired from Enobia, Taligen and Orphatec, continue to conduct clinical trials, including the clinical trial initiated during the third quarter of 2011 to investigate eculizumab as a treatment for patients with STEC-HUS, and continue to develop manufacturing, sales, marketing and distribution capabilities in the United States and abroad. Under controlled settings, patients in our eculizumab trials all receive vaccination against Meningococcal infection prior to first administration of Soliris and patients who are prescribed Soliris in most countries are required by prescribing guidelines to be vaccinated prior to receiving their first dose. During the course of treatment, patients may suffer adverse events, including death, for reasons that may or may not be related to Soliris. We believe we will have sufficient available cash to pay the liability when it becomes due. Since our foreign currency hedges are designed to offset gains and losses on our monetary assets and liabilities, we do not expect that a hypothetical 10% adverse fluctuation in exchange rates would result in a material change in the fair value of our foreign currency sensitive net assets, which include our monetary assets and liabilities and our foreign exchange forward contracts. As of December 31, 2011, we had approximately $464.9 million of U.S. federal net operating loss carryforwards (NOL's), available to reduce taxable income in future years. Government initiatives that affect coverage and reimbursement of drug products could adversely affect our business. Manufacture of a biologic requires a multi-step controlled process and even minor problems or deviations could result in defects or failures. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. It is not possible to predict how long the approval processes of the FDA or any other applicable federal or foreign regulatory authority or agency for any of our product candidates will take or whether any such approvals ultimately will be granted. In connection with the acquisition of Enobia in February 2012, we borrowed approximately, under the facility and used our available cash for the remaining purchase price. As in several other conditions with severe and uncontrolled complement activation, including aHUS, complement activation in STEC-HUS results in TMA. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Alexion stockholders in connection with the proposed mergers, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Selling, general and administrative expense: Change in fair value of contingent consideration (4), (Gains) and losses related to strategic equity investments(9), Gain related to modification of purchase option(10), 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). Investors and security holders will be able to obtain free copies of the registration statement and proxy statement/prospectus (if and when available) and other documents containing important information about Alexion, AstraZeneca and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. With the consent of the lenders and the administrative agent and subject to satisfaction of certain conditions, we may increase the facility by, depending on our consolidated leverage ratio of our cash to liabilities (as calculated in accordance with the Credit Agreement). The estimates of amounts potentially owed to other third parties may be influenced by the outcome of future litigation or other claims, if any, the results of which are uncertain.
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