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10-Q: XENOPORT INC | 920-183 Dumps and actual test Questions with VCE practice Test

(EDGAR online by means of COMTEX) -- item 2. administration's dialogue and analysis of monetary circumstance and consequences of Operations

This Quarterly file on kindly 10-Q consists of ahead-looking statements inside the significance of section 27A of the Securities Act of 1933, as amended, and

Overview

XenoPort, Inc. is a biopharmaceutical enterprise focused on setting up and commercializing a portfolio of internally discovered product candidates for the capabilities medicine of neurological and other issues. we're at present commercializing HORIZANT(R) (gabapentin enacarbil) prolonged-unlock pills in the united states and setting up their novel fumaric acid ester product candidate, XP23829, as a workable treatment for psoriasis and doubtlessly for relapsing forms of assorted sclerosis, or MS. furthermore, REGNITE(R) (gabapentin enacarbil) extended-unencumber tablets are being marketed in Japan through Astellas Pharma Inc., or Astellas. HORIZANT has been authorised by means of the U.S. meals and Drug Administration, or FDA, for the treatment of reasonable-to-severe simple stressed legs syndrome, or RLS, in adults and for the management of postherpetic neuralgia, or PHN, in adults. RLS, besides referred to as Willis-Ekbom ailment, is a neurological ailment characterised by artery of an prod to circulate the legs, continually brought about or accompanied by artery of uncomfortable and unpleasant sensations in the legs. PHN is a neuropathic

We reacquired building and commercialization rights to HORIZANT from Glaxo community restricted, or GSK, their former collaborator for this product, on may 1, 2013. they believe concentrated their promotional and sales efforts on metier docs in selected geographic territories. They initiated their commercialization efforts in about forty territories and, by using the starting of the third quarter of 2014, elevated the revenue drive into about 70 territories within the u.s.. we've initiated within the first quarter of 2015 an additional enlargement of their income coerce and method to cowl up to 120 territories through mid-2015. Their revenue corporation contains each XenoPort-employed earnings representatives and condense income representatives who are fully dedicated to HORIZANT education and promoting. They rely on, and are expecting to proceed to depend on, their condense income arduous to deliver lower back-office logistical usher for the XenoPort-employed income representatives.

Our future product revenue of HORIZANT will be based upon the success of their thoughts for commercialization, promoting and distribution, as well as their skill to correctly execute on these actions and to comply with applicable legal guidelines, laws and regulatory requirements. Their commercialization efforts may additionally sooner or later now not be a hit. during this regard, they rely on third parties to role quite a lot of features regarding the sale and distribution of HORIZANT, key aspects of which are out of their direct control. If these third-party provider providers fail to agree to applicable legal guidelines and laws, fail to meet expected cut-off dates or otherwise achieve not effect their contractual responsibilities to us, or if HORIZANT encounters physical or natural damage at their facilities, their potential to carry HORIZANT to meet industrial require could be drastically impaired.

XP23829 is a fumaric acid ester compound and a patented prodrug of monomethyl fumarate, or MMF. Fumaric acid ester compounds believe shown immuno-modulatory and neuroprotective results in mobile-primarily based systems and preclinical models of disorder. A fumaric acid ester product is accepted in Germany for the remedy of psoriasis, and a fumaric acid ester compound, referred to as TECFIDERA (dimethyl fumarate), become accredited by the FDA in March 2013 for the medicine of relapsing forms of MS and with the aid of the

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European fee in February 2014 for the medication of relapsing-remitting MS. they believe evaluated XP23829 in phase 1 reviews with match subjects to assess its protection and pharmacokinetic profile. In June 2014, they initiated a phase 2 medical tribulation of XP23829 in patients with average-to-extreme persistent plaque-classification psoriasis. they are evaluating four hundred mg and 800 mg of XP23829 dosed once a day and four hundred mg of XP23829 dosed twice a day during this trial, and anticipate that the records may well be attainable by artery of the third quarter of 2015.

We besides believe two other product candidates: arbaclofen placarbil, or AP, and XP21279. AP is licensed to Indivior PLC, a brand new company entity that became formed through divestment of the pharmaceutical division from Reckitt Benckiser community plc. In might besides 2014, they entered into an unique license condense with Indivior, which became advantageous on June 19, 2014. under the phrases of this agreement, they granted exclusive, world-broad rights to boost and commercialize pharmaceutical products containing AP and other prodrugs of baclofen or R-baclofen, or AP products, for shameful indications, discipline to their revise of first negotiation to collaborate to better and commercialize AP items for non-dependancy signals. In alternate for these rights, they acquired an upfront, non-refundable money charge of $20.0 million in June 2014 and besides bought an extra $5.0 million charge in July 2014 after their birth of positive substances, each of that believe been recognized within the third quarter of 2014. we're additionally eligible to acquire combination money funds of as much as $a hundred and twenty.0 million upon the achievement by Indivior of Definite contingent adventure-based mostly payments, of which $70.0 million are regulatory and construction-based and $50.0 million are commercialization-based. moreover, they are entitled to regain hold of tiered double-digit royalty funds of as much as the mid-young adults on a percent basis on skills future web sales of AP items within the united states, and high single-digit royalty funds on potential future internet earnings of AP products backyard the united states. XP21279 is a potential medication for patients with advanced idiopathic Parkinson's ailment. They can besides enhance it further, to the extent that their elements permit, or they can besides enter into third-celebration trade relationships in an endeavor to effect such development actions.

We at present rely, and may sooner or later rely, on collaboration, partnership, licensing and different strategic arrangements with third-celebration enterprise partners. The talents for gabapentin enacarbil, XP23829 and/or XP21279 could be more desirable via third-celebration strategic preparations that might further development and/or expand commercialization efforts of those property. As such, they method to enter into partnerships, collaborations or other strategic arrangements with pharmaceutical corporations: (1) when access to a main trust universal practitioner or an extended sales coerce is faultfinding to maximize the trade expertise of gabapentin enacarbil, XP23829 and/or XP21279 within the u.s.;

historically, revenues recognized through may 1, 2013 had been basically constructed from upfront, milestone and contingent adventure-primarily based payments from their collaboration and partnership arrangements. while a significant portion of their revenues in 2014 consisted of revenues from the awareness of cash funds they bought below their license settlement with Indivior, and they can besides sooner or later value revenues from contingent-experience based mostly payments from Indivior, they are expecting the future composition of their revenues to consist primarily of revenues from HORIZANT product earnings. youngsters they are recognizing salary from HORIZANT product income within the united states, their relative need of commercialization journey as an organization with admire to HORIZANT product earnings will create future operating consequences intricate to foretell. in this regard, their product revenue income might besides disagree vastly from age to length as their commercialization efforts development, and they may well be unable to meaningfully boost HORIZANT product income or otherwise efficaciously commercialize HORIZANT in a timely manner or in any respect. They additionally call that the costs of expanding and keeping their earnings and advertising capabilities, including with admire to the internal and exterior fees of aiding, retaining and expanding their XenoPort-employed income representatives and their condense income representatives, and keeping and expanding a distribution and supply chain infrastructure will proceed to be massive, and these charges may besides exceed the revenues that we're able to generate from HORIZANT product sales. They recorded $6.6 million in net revenue from HORIZANT shameful through the three months ended March 31, 2015.

Gabapentin enacarbil is licensed to Astellas in Japan. they are entitled to obtain percentage-primarily based excessive-teen royalties on net income of REGNITE in Japan, and the royalties are diagnosed as earnings when royalty payments are received. in the three months ended March 31, 2015, the royalty earnings from internet income of REGNITE in Japan turned into $0.1 million. They anticipate royalty revenues from their partnership with Astellas to fluctuate in accordance with the outcomes of their commercialization, marketing and distribution efforts for REGNITE in Japan and, to a lesser extent, overseas exotic money fluctuations; despite the fact, they achieve not anticipate that royalty revenues from their partnership with Astellas could be significant.

We are expecting their analysis and construction costs to enhance in 2015 compared to 2014 levels basically due to extended development costs for XP23829, together with their phase 2 medical tribulation in sufferers with reasonable-to-extreme interminable plaque-type psoriasis that become initiated in June 2014, as well as accelerated fees in anticipation of potential section 3 medical actions. The timing and volume of analysis and construction prices incurred will primarily depend upon the extent of latest or future clinical trials for XP23829 as well as the connected charges linked to their development corporation, regulatory necessities for their product candidates, product candidate manufacturing fees and their skill to raise further cash. Their future analysis and building fees are discipline to numerous assumptions that may additionally exhibit to be incorrect and besides are matter to hazards regarding the problem and skepticism of hospital al success and regulatory approvals of their product candidates. In 2015, they anticipate their selling, commonplace and administrative costs to raise compared to 2014 tiers primarily due to internal and external expenses of aiding, protecting and expanding their XenoPort-employed revenue representatives and their condense income representatives, as well as from maintaining and increasing advertising and marketing, distribution and other trade capabilities for HORIZANT, largely through third-celebration service suppliers.

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On February 3, 2015, they accomplished a personal placement of $115.0 million amalgam main quantity of 2.50% Convertible Senior Notes due 2022, or the 2022 Notes. The net proceeds from the providing of the 2022 Notes were $111.3 million, after deducting the initial customer's discount and offering fees payable by artery of us. For greater guidance on the 2022 Notes, contemplate "Liquidity and Capital elements - 2022 Notes" under.

We believe that their latest capital resources, along side pastime earnings from their investments and expected product income, can be adequate to fund their projected operating requirements for at least the subsequent twelve months. they now believe based their cash sufficiency assay on assumptions that may besides exhibit to be improper, and they might utilize their purchasable capital components sooner than they predict. additional, their working method may besides trade, and they may wish further funds to meet operational needs and capital necessities for product construction and commercialization prior to planned. They haven't any credit facility or different dedicated sources of capital. they now believe competencies contingent adventure-primarily based and royalty payments that they are eligible to acquire beneath their partnerships with Astellas and Indivior. aside from the proposed medical tribulation in patients with AUD that the NIAAA plans to behavior, we're fully liable for shameful HORIZANT commercialization and construction activities, including shameful publish-advertising and marketing requirements and commitments. Such fees could be more suitable than they expect, or earnings of HORIZANT may be lower than they weigh on, either or both of which may accelerate their need for further capital. in addition, they achieve not esteem that revenues generated from HORIZANT and REGNITE revenue and other revenues generated from their partnerships with Astellas and Indivior will be satisfactory on my own to maintain their operations, at the least within the near term, and they for this intuition anticipate to proceed to journey immoral money flows for the foreseeable future as they fund their operating losses and capital bills. additional money may additionally not be accessible to us on terms which are desirable to us, or at all. If adequate funds don't appear to be, or they anticipate that they may no longer be, available on a well timed groundwork, they could be required to, amongst other issues, reduce the amount of materials dedicated to medical affairs, advertising, promoting or income of HORIZANT, curtail or delay further XP23829 building or conduct further cadaver of workers or different cost savings, any of which may believe a fabric adverse repercussion on their company and prospects.

crucial Accounting policies and significant Judgments and Estimates

Our administration's dialogue and evaluation of their financial condition and consequences of operations is based on their fiscal statements, which had been prepared based on accounting ideas generally authorized in the united states. The coaching of these monetary statements requires us to create estimates and assumptions that palpate the said quantities of belongings and liabilities and the disclosure of contingent property and liabilities on the date of the monetary statements, as smartly because the pronounced revenues and fees shameful over the reporting durations. On an ongoing basis, they esteem their estimates and judgments concerning salary attention, inventories, inventory-based mostly compensation, objective cost measurements and collected fees. They base their estimates on historical adventure and on numerous different components that they agree with are cost-efficient below the instances, the results of which figure the foundation for making judgments concerning the carrying cost of belongings and liabilities that aren't readily obvious from different sources. precise results may besides range from these estimates beneath distinctive assumptions or situations. Their vital accounting guidelines and significant judgments and estimates are unique in their Annual report on figure 10-okay filed with the Securities and trade commission on February 27, 2015.

fresh Accounting Pronouncements

In may additionally 2014, the fiscal Accounting requirements Board, or FASB, issued Accounting requisites update, or ASU, No. 2014-09, income from Contracts with valued clientele: matter matter 606 (ASU 2014-09), which creates a unique supply of revenue recommendation beneath U.S. frequently authorized accounting principles, or GAAP, for shameful agencies in shameful industries. The core precept of ASU 2014-09 is that salary should still be identified in a artery that depicts the switch of promised goods or features to purchasers in an amount that reflects the distinction to which the entity expects to be entitled in change for these goods or capabilities. ASU 2014-09 defines a five-step process with a purpose to achieve this core principle, which may additionally require the employ of judgment and estimates. ASU 2014-09 additionally requires expanded qualitative and quantitative disclosures concerning the character, quantity, timing and skepticism of revenue and cash flows bobbing up from contracts with customers, together with huge judgments and estimates used. ASU 2014-09 will be constructive for us within the first quarter of fiscal 2017, and early adoption is not permitted. They may additionally undertake ASU 2014-09 both by artery of a full retrospective approach for shameful periods presented in the length of adoption or a modified retrospective approach. On April 1, 2015, the FASB voted to submit a extend within the valuable date of ASU No. 2014-09. The proposed new valuable date will be annual reporting intervals starting after December 15, 2017, and the interim intervals within that 12 months and will enable early adoption for shameful entities as of the unpretentious valuable date for public company entities, which became annual reporting periods starting after December 15, 2016. we're at the flash evaluating the repercussion that ASU 2014-09 may believe on their economic statements and believe not yet determined which transition method they will observe.

In August 2014, the FASB issued ASU No. 2014-15, Presentation of monetary Statements-Going situation (Subtopic 205-40): Disclosure of Uncertainties about an Entity's capability to continue as a Going difficulty (ASU 2014-15). This update is meant to silhouette administration's accountability to evaluate whether there's immense doubt about a firm's skill to continue as a

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going problem and to deliver linked footnote disclosures. ASU 2014-15 requires management to verify an entity's skill to continue as a going challenge through incorporating and increasing upon positive principles that are at present in U.S. auditing specifications. peculiarly, the amendments: (1) deliver a definition of the term monstrous doubt; (2) require an evaluation each reporting age including age in-between periods; (three) deliver concepts for seeing that the mitigating result of management's plans; (four) require Definite disclosures when significant doubt is alleviated because of consideration of management's plans;

In April 2015, the FASB issued ASU No. 2015-03, hobby - Imputation of interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance charges. Debt issuance charges are precise incremental prices, aside from these paid to the lender, which are directly attributable to issuing a debt instrument (i.e., third party prices). earlier than this usual, debt issuance fees believe been required to be offered within the equilibrium sheet as a deferred charge (i.e., an asset). This presentation differed from the presentation for a debt chop price, which is an immediate adjustment to the carrying cost of the debt (i.e., a contra liability). These distinctive stability sheet presentation necessities created useless complexity. This new unpretentious requires that every one prices incurred to matter debt be presented in the steadiness sheet as a direct deduction from the carrying value of the debt. This new commonplace doesn't palpate the recognition and size of debt issuance fees. for this reason, the amortization of such costs should still continue to be calculated using the activity system and mentioned as interest expense. ASU No. 2015-03 is constructive for us in the first quarter of fiscal 2016, with early adoption authorised. They elected to early adopt this criterion by means of having it be positive for the reporting length ending on March 31, 2015, and as such offered $0.5 million in debt issuance prices as a direct deduction from the carrying value of their convertible senior notes.

In April 2015, the FASB issued ASU No. 2015-05, Intangibles - Goodwill and other

results of Operations Three Months Ended March 31, 2015 and 2014 Revenues Their net product revenue income consisted of earnings of HORIZANT. Their collaboration income consisted of the focus of revenues from the upfront funds from their partnership with Astellas. Their royalty income turned into from Astellas and changed into in accordance with Astellas' internet sales of REGNITE in Japan. Three Months Ended March 31, exchange 2015 2014 $ % (In thousands, apart from percentages) Product sales, net $ 6,639 $ 2,957 $ three,682 125 % Collaboration profits 284 283 1 0 % Royalty income a hundred and forty four 135 9 7 % total revenues $ 7,067 $ 3,375 $ 3,692 109 %

The enhance in total revenues for the three months ended March 31, 2015, in comparison to the same duration in 2014, became substantially because of extended HORIZANT web product income essentially from a mount in earnings volume as a result of superior promotional efforts and from an expand in common web promoting expenses due to further cost raises.

We are expecting the long Run composition of their revenues to consist basically of revenues from HORIZANT internet product sales. They are expecting their HORIZANT internet product sales to enhance in 2015 compared to 2014 ranges and that they should be based upon the

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success of their suggestions for commercialization, promotion and distribution, as well as their skill to successfully execute on these activities, including their deliberate income drive enlargement, and to conform to applicable legal guidelines, regulations and regulatory requirements. They anticipate royalty salary from their partnership with Astellas to fluctuate in line with the results of its commercialization, advertising and marketing and distribution efforts for REGNITE in Japan and, to a lesser extent, overseas exotic money fluctuations; however, they achieve not call that royalty revenues from their partnership with Astellas can be meaningful. They are expecting collaboration earnings to fluctuate according to Indivior's timing and fulfillment of AP products contingent-experience based payments and to the extent they enter into new partnership, collaboration or different strategic arrangements for their marketed product or any of their product candidates.

can charge of Product revenue

cost of product earnings consisted of the direct and roundabout expenses to fabricate product bought, together with tableting, packaging, storage, transport and dealing with expenses regarding their product revenue of HORIZANT. can charge of product earnings besides included uncooked substances, peculiarly gabapentin enacarbil, received from GSK as a share of the reacquisition of the HORIZANT trade and recorded at reasonable cost. The reasonable value of the inventory acquired from GSK represents a lessen charge than if new uncooked materials believe been bought at current third-birthday party costs.

Three Months Ended March 31, alternate 2015 2014 $ % (In heaps, except percentages)

The enhance in charge of product income in the three months ended March 31, 2015, compared to the equal duration in 2014, was primarily from an expand in volume of HORIZANT product sales, offset in share by using $0.1 million in charges related to the transfer of producing responsibilities to us from GSK incurred during the three months ended March 31, 2014.

We call can charge of product income for HORIZANT to remain distinctly consistent as a percentage of internet product earnings for the leavings of the year, in comparison to the percentage for the three months ended March 31, 2015.

analysis and development prices research and construction prices consisted of charges linked to conducting preclinical studies and clinical trials, manufacturing building efforts for scientific trials and actions regarding building-related regulatory filings. . . .

might besides 07, 2015

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Operations & Process Management: Principles & Practice for Strategic ImpactOperations & Process Management: Principles & Practice for Strategic Impact
By Nigel Slack, Alistair Jones
Publisher : Pearson (Feb 2018)
ISBN10 : 129217613X
ISBN13 : 9781292176130
Our ISBN10 : 129217613X
Our ISBN13 : 9781292176130
Subject : Business & Economics
Price : $75.00
Computer Security: Principles and PracticeComputer Security: Principles and Practice
By William Stallings, Lawrie Brown
Publisher : Pearson (Aug 2017)
ISBN10 : 0134794109
ISBN13 : 9780134794105
Our ISBN10 : 1292220619
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Subject : Computer Science & Technology
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Urban EconomicsUrban Economics
By Arthur O’Sullivan
Publisher : McGraw-Hill (Jan 2018)
ISBN10 : 126046542X
ISBN13 : 9781260465426
Our ISBN10 : 1260084493
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Subject : Business & Economics
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Urban EconomicsUrban Economics
By Arthur O’Sullivan
Publisher : McGraw-Hill (Jan 2018)
ISBN10 : 0078021782
ISBN13 : 9780078021787
Our ISBN10 : 1260084493
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Subject : Business & Economics
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Understanding BusinessUnderstanding Business
By William G Nickels, James McHugh, Susan McHugh
Publisher : McGraw-Hill (Feb 2018)
ISBN10 : 126021110X
ISBN13 : 9781260211108
Our ISBN10 : 126009233X
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Subject : Business & Economics
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Understanding BusinessUnderstanding Business
By William Nickels, James McHugh, Susan McHugh
Publisher : McGraw-Hill (May 2018)
ISBN10 : 1260682137
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Subject : Business & Economics
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Understanding BusinessUnderstanding Business
By William Nickels, James McHugh, Susan McHugh
Publisher : McGraw-Hill (Jan 2018)
ISBN10 : 1260277143
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Subject : Business & Economics
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Understanding BusinessUnderstanding Business
By William Nickels, James McHugh, Susan McHugh
Publisher : McGraw-Hill (Jan 2018)
ISBN10 : 1259929434
ISBN13 : 9781259929434
Our ISBN10 : 126009233X
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Subject : Business & Economics
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By Peter W. Cardon
Publisher : McGraw-Hill (Jan 2017)
ISBN10 : 1260128474
ISBN13 : 9781260128475
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Subject : Business & Economics, Communication & Media
Price : $39.00
920-183920-183
By Peter Cardon
Publisher : McGraw-Hill (Feb 2017)
ISBN10 : 1260147150
ISBN13 : 9781260147155
Our ISBN10 : 1259921883
Our ISBN13 : 9781259921889
Subject : Business & Economics, Communication & Media
Price : $64.00
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