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Test Number : ISEB-BA1
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Foundation Certificate in Business(R) Analysis book

Sage Therapeutics publicizes 2d Quarter 2019 fiscal consequences and Highlights Pipeline and enterprise progress | ISEB-BA1 Dumps and existent exam Questions with VCE rehearse Test

CAMBRIDGE, Mass.--(enterprise WIRE)--Aug 6, 2019--

nowadays, Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company dedicated to establishing novel treatment plans with the erudition to radically change the lives of americans with debilitating issues of the mind, pronounced trade highlights and monetary consequences for the 2nd quarter ended June 30, 2019.

“Eight years ago, Sage laid the basis to develop into the leading brain fitness enterprise during a time when there turned into broad skepticism about the skill to Strengthen novel medicines,” spoke of Jeff Jonas, M.D., chief executive officer at Sage. “these days, their first compound is now their first commercially launched drug and their song list of success is a privilege away outcomes of their wonderful strategy to R&D and medical construction programs. Sage’s deliberate determination-making approach around pipeline management has allowed us to build what I feel is a leading multi-franchise enterprise concentrated on getting patients greater, sooner.”

Portfolio Updates:

Sage is advancing a portfolio of novel and differentiated product candidates designed to enhance reason fitness via concentrated on the GABA and NMDA receptor methods. Dysfunction in these programs is view to subsist at the core of a big number of neurological and neuropsychiatric problems.

melancholy Franchise:

Led by ZULRESSO™ (brexanolone) injection CIV, authorised via the U.S. food and Drug Administration (FDA) in March 2019 as the first medication peculiarly indicated for postpartum depression (PPD), and SAGE-217, Sage’s next-technology superb allosteric modulator (PAM) of GABA A receptors being evaluated in medical development as a treatment for a lot of affective disorders. SAGE-217 has got leap forward remedy designation from the U.S. FDA for the medication of essential depressive disease (MDD).

  • ZULRESSO: The U.S. commercial launch of ZULRESSO commenced on June 24, 2019 following scheduling by using the U.S. Drug Enforcement Administration (DEA) and finalization of the product label. ZULRESSO is administered in a healthcare environment licensed below the ZULRESSO possibility evaluation and Mitigation approach (REMS) program.
  • websites of Care:
  • more than one hundred healthcare amenities, together with hospitals, infusion facilities, health centers, and fertility centers are ZULRESSO REMS licensed, covering fifty five of the sincere one hundred forty Metropolitan Statistical Areas within the americafc4d7a09cf76db3f093ffbf97788fed5)
  • ZULRESSO REMS certification is one step within the procedure for sites of keeping to subsist medicine capable. Given the necessity to achieve formulary approval, set up protocols for administering ZULRESSO and cozy satisfactory reimbursement, full activation of sites can select an estimated 6 to 9 months or extra. Sage anticipates launch momentum to construct in 4Q 2019 into 2020.
  • Payer insurance and entry:
  • As of August 1, 2019, plans representing more than sixty five percent of entire covered lives beget dedicated to propitious insurance with either easy or no restrictions.
  • Plans overlaying approximately 30 % of lined lives are nonetheless reviewing ZULRESSO, with selections expected within the coming months. They hope these payers to cowl ZULRESSO on a scientific exception basis except a policy is in location.
  • affected person assist:
  • Sage valuable, Sage’s affected person lead center, formally opened in June and is proposing various patient components to assist girls with PPD and their households, including: dedicated case managers who can supply assistance to mitigate navigate the medicine event; personalised lead to assist with knowing insurance and coverage alternatives; fiscal counsel classes for eligible sufferers; and access to academic supplies and counsel via connections to more than 60 country wide and local advocacy organizations.
  • SAGE-217: In July 2019, Sage introduced medical findings from an open-label aspect 2 clinical tribulation of SAGE-217 in bipolar melancholy (ARCHWAY study), as well as evaluation of datasets from up to now achieved medical experiences in MDD and PPD showing fanciful signals for advantage construction of SAGE-217 in generalized keeping disease and medication-resistant depression (TRD). Sage plans to initiate a medical celebrate at evaluating SAGE-217 in TRD. Timing for initiation of this resolve can subsist supplied in 2H 2019.
  • ARCHWAY examine: results from this open-label fraction 2 medical tribulation evaluating the safeguard and exercise of SAGE-217 in 35 adult men and women with average to extreme bipolar I/II ailment with a major depressive episode established a swift and sturdy response to treatment as measured through the Sir Bernard Law–Åsberg melancholy ranking Scale (MADRS) and a statistically significant development compared to baseline at Day 15; the impact became maintained throughout the conclusion of the comply with-up length at Day 42. the most measure opposed routine (AEs) within the tribulation beget been somnolence, headache, diarrhea, and sedation. there were two cases of momentary hypomania off-medication; no mania or sober AEs were pronounced within the trial.
  • SAGE-217 in sufferers who didn't reply to anti-depressant therapy at baseline: results from a publish-hoc analysis of 51 patients from the MDD-201B and ROBIN (PPD) stories with ongoing signs of melancholy despite receiving ordinary anti-depressant pharmacotherapy tested a speedy response to medication and discount in depressive signs within the SAGE-217-handled neighborhood in comparison to the placebo neighborhood which was long lasting over the follow-up period. the most commonplace (>5%) AEs within the MDD-201B resolve were headache, dizziness, nausea, and somnolence; essentially the most measure (>5%) AEs in the ROBIN celebrate at had been somnolence, headache, dizziness, higher respiratory tract an infection, diarrhea, and sedation.
  • SAGE-217 in nervousness: analysis evaluating response on the Hamilton keeping ranking Scale (HAM-A) in 89 patients from the MDD-201B examine and 151 patients from the ROBIN (PPD) study Tested speedy onset of a clinically meaningful anxiolytic consequence in the SAGE-217-handled neighborhood compared to the placebo group which turned into long lasting past initial medication over the study period.
  • The SAGE-217 medical software evaluating the skills of SAGE-217 as a short-direction episodic, hastily-performing oral remedy for MDD and PPD is progressing as anticipated. moreover the two completed, high-quality pivotal studies, one in MDD and one in PPD, there are 4 further ongoing or planned reports, including:
  • MOUNTAIN study: Evaluating a dosing regimen of two weeks of 20mg or 30mg SAGE-217 medication in comparison to placebo in sufferers with MDD, with four weeks of blinded follow-up. accurate-line records from this pivotal resolve are anticipated in 4Q 2019 or 1Q 2020.
  • Retreatment studies: These reviews are designed to provide longer-time era retreatment and comply with-up security and tolerability data.
  • REDWOOD resolve (MDD-302): Placebo-managed pivotal tribulation to deem fastened interval SAGE-217 monotherapy protection medicine (with out common antidepressants) for up to a year. The tribulation is anticipated to commence in 3Q 2019.
  • SHORELINE analyze: Open-label pivotal tribulation evaluating SAGE-217 in treatment-free intervals and as-needed over the route of as much as a 12 months. sufferers receive an initial two-week route of SAGE-217 remedy and are assessed each eight weeks for competencies relapse of depressive signs. precise-line statistics are expected in 2020.
  • RAINFOREST analyze: fraction 3 clinical tribulation evaluating two weeks of 30mg SAGE-217 medication in comparison to placebo in patients with MDD and comorbid insomnia. appropriate-line statistics are expected in 2020.
  • Neurology Franchise:

    SAGE-324, a subsequent-technology PAM of GABA A receptors, is in development as a workable remedy for neurological circumstances, comparable to measure tremor (ET), epilepsy and Parkinson’s disease.

  • SAGE-324: In July 2019, Sage announced outcomes from fraction 1 single-ascending dose (unhappy) and multiple-ascending dose (MAD) experiences of SAGE-324 in fit volunteers, in addition to effects from a fraction 1b sole dose, open-label resolve of SAGE-324 in six sufferers with ET.
  • unhappy and MAD reports: effects tested a pharmacokinetic (PK) profile suitable for constant dosing in signs amenable to the GABA PAM mechanism and an extended half-existence, an ascribe neatly-desirable for pile in neurological situations the Place sturdy plasma levels are a medical problem.
  • SAGE-324 in ET: data Tested a reduction in tremor from baseline, with a maximum suggest reduction in accelerometer higher limb complete score of forty eight percent. a transparent pharmacokinetic/pharmacodynamic relationship was accompanied in plasma awareness over 24 hours. Sage plans to initiate a aspect 2 clinical study of SAGE-324 in basic tremor in 2H 2019.
  • SAGE-324 became generally smartly tolerated. essentially the most measure (>5%) AEs were feeling of relaxation, dizziness, and somnolence.
  • Neuropsychiatry Franchise:

    SAGE-718, a first-in-class NMDA receptor PAM, is in pile as a workable therapy for cognitive issues linked to NMDA receptor dysfunction.

  • SAGE-718: In July 2019, consequences from 5 section 1 in shape volunteer reports, together with sad, MAD, and three target rendezvous biomarker studies established SAGE-718 turned into frequently smartly-tolerated within the reports with a protracted half-existence per as soon as-day by day dosing. extra consequences Tested SAGE-718 had consequences on electrophysiological, useful neuroimaging, and cognitive measures in keeping with CNS endeavor. Sage plans to deem SAGE-718 in aspect 2 clinical pile classes in inescapable neurodegenerative problems and other conditions the Place govt feature is impaired. Timing for initiation of those stories can subsist provided in 2H 2019.
  • anticipated Upcoming Milestones

  • top-line information Readouts:
  • SAGE-718 aspect 1 cohort statistics in Huntington’s disease (2H 2019)
  • SAGE-217 MDD fraction three MOUNTAIN celebrate at (4Q 2019/1Q 2020)
  • SAGE-217 MDD aspect three RAINFOREST and SHORELINE reviews (2020)
  • medical tribulation Initiations:
  • part 2 placebo-managed celebrate at with SAGE-324 in simple Tremor (2H 2019)
  • phase 3 REDWOOD (MDD-302) tribulation with SAGE-217 (3Q 2019)
  • financial results for the second Quarter of 2019

  • Revenues: Sage recorded $0.9 million in revenues within the 2d quarter of 2019, compared to $ninety.0 million for a similar length of 2018. 2nd quarter revenues in 2019 blanketed $0.5 million of internet revenues from income of ZULRESSO, which consisted utterly of channel stocking in coaching for the U.S. industrial launch and $0.four million in collaboration revenues from Shionogi & Co., Ltd. related to repayment of product price. entire revenues for the second quarter of 2018 beget been brought on by the $90.0 million upfront charge from Sage’s strategic collaboration with Shionogi & Co., Ltd.
  • cash position: cash, money equivalents, constrained money, and marketable securities as of June 30, 2019 had been approximately $1.2 billion, compared to $925.1 million at December 31, 2018. The enhance become basically due to proceeds from Sage's follow-on public offering achieved in February 2019.
  • R&D charges: analysis and development charges were $89.1 million, together with $13.7 million of non-cash inventory-primarily based compensation cost, in the second quarter of 2019, compared to $sixty nine.0 million, including $12.1 million of non-money inventory-primarily based compensation fee, for a similar duration of 2018. The extend in R&D costs year-over-year became essentially due to advancement of the pivotal software for SAGE-217 in depression and persisted research efforts throughout the company’s early-stage medical and discovery pipeline.
  • SG&A fees: selling, gardenvariety and administrative costs had been $88.2 million, together with $21.1 million of non-cash inventory-based mostly compensation rate, within the 2nd quarter of 2019, in comparison to $43.2 million, including $sixteen.9 million of non-money stock-primarily based compensation fee, for a similar duration of 2018. The boost in SG&A prices was primarily as a result of the boost in personnel-related prices, knowledgeable costs to mitigate increasing operations, expenses involving the industrial launch of ZULRESSO, and facilities-linked charges to lead increasing operations.
  • web Loss: net loss become $168.2 million for the 2nd quarter of 2019 in comparison to a web loss of $17.0 million, for the similar era of 2018. The change in web loss changed into driven through $90 million in salary involving their Shionogi collaboration that they recorded in the second quarter of 2018.
  • economic guidance

  • based on its latest working plan, Sage anticipates that its steadiness of cash, cash equivalents, restricted cash, and marketable securities should subsist as a minimum $950 million on the conclusion of 2019.
  • Sage expects that its operating expenses will enhance year-over-year in 2019 to assist persisted pipeline advancement and commercialization of ZULRESSO in PPD.
  • convention appellation assistance

    Sage will host a conference appellation and webcast nowadays at eight:00 a.m. EDT to talk about its second quarter 2019 monetary consequences and accurate company updates. The are vital webcast will also subsist accessed on the investor web page of Sage's website at investor.sagerx.com. A replay of the webcast could subsist accessible on Sage's web site approximately two hours after the completion of the suffer and may subsist archived for as much as 30 days.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical trade committed to constructing novel treatment options with the expertise to seriously change the lives of people with debilitating problems of the brain. we're pursuing new pathways with the goal of enhancing brain fitness and their melancholy, neurology and neuropsychiatry franchise courses aim to change how reason issues are view about and treated. Their mission is to originate drug treatments that matter so americans can Get more suitable, sooner. For greater tips, gratify talk over with www.sagerx.com.

    ahead-looking Statements

    a lot of statements during this liberate concern Sage's future expectations, plans and possibilities, together with with out trouble: their views and expectations concerning their industrial launch of ZULRESSO, together with the expertise timing of availability of sites able to administering ZULRESSO, the competencies timing of profits momentum and the advantage for compensation of ZULRESSO; their development plans, dreams and approach and the skills timing and consequences of their pile efforts; their credence in the competencies of their product candidates in quite a few signs; the potential profile and improvement of their product candidates; the goals, probability and skills for their company; and their expectations regarding their money position at yr-conclusion and increases in working expense. These statements picture forward-searching statements as that time era is described in the private Securities Litigation Reform Act of 1995. These ahead-searching statements are neither promises nor ensures of future efficiency, and are locality to loads of risks and uncertainties, a lot of which are beyond their control, which might trigger precise outcomes to vary materially from those contemplated in these ahead-searching statements, including the hazards that: they may additionally Come across concerns or other challenges in commercializing ZULRESSO, together with considerations involving market acceptance by pass of healthcare suppliers, healthcare settings and women with PPD, concerns involving the willingness of sites to manage ZULRESSO, concerns related to repayment, concerns concerning the requirements of the REMS, and challenges linked to execution of their earnings and patient mitigate activities, which in every case might restrict the abilities of ZULRESSO and the timing and amount of future revenues; consequences done with expend of ZULRESSO in the remedy of PPD in trade expend may subsist several than followed in medical trials, and can fluctuate among patients; the variety of ladies with PPD or the unmet necessity for additional treatment options could subsist vastly smaller than they predict; they can also stumble upon sudden security or tolerability considerations with ZULRESSO or any of their product candidates; they can also not subsist a success in their construction of any of their existing or future product candidates in any indication we're presently pursuing or may additionally in the future pursue; success in prior stage medical trials or nonclinical studies may additionally now not subsist repeated or observed in ongoing or future reports of any of their product candidates; ongoing and future scientific or nonclinical outcomes may generate outcomes which are diverse than they hope or can also now not lead additional development or subsist ample to gain regulatory approval of their product candidates; they may additionally Come to a conclusion that a development pathway for certainly one of their product candidates in a sole or greater signs is not any longer workable or profitable or that the unmet want now not exists; the FDA may also Come to a conclusion that the pile software for any of their product candidates, even though high-quality, is not adequate for a brand new drug software filing or approval; choices or actions of the FDA or different regulatory groups may additionally beget an consequence on the initiation, timing, design, measurement, development and charge of clinical trials and their means to proceed with further development; they may suffer slower than expected initiation or enrollment in ongoing or future scientific trials; they can also encounter surprising security or tolerability considerations with their product candidates; the internal and exterior costs required for their ongoing and planned research and construction efforts, and to build their company in connection with such activities, and the resulting expense increases and expend of cash, could subsist larger than expected which can antecedent us to alternate or curtail a few of their plans; and they may additionally encounter technical and other surprising hurdles within the development of their product candidates; in addition to those dangers more fully discussed in the locality entitled "possibility elements" in their most accurate quarterly record filed with the Securities and alternate commission (SEC), and discussions of competencies risks, uncertainties, and different crucial factors in their subsequent filings with the SEC. additionally, any ahead-looking statements signify their views best as of today, and will not subsist relied upon as representing their views as of any subsequent date. They explicitly disclaim any duty to update any forward-searching statements.

      Sage Therapeutics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (in hundreds, except partake and per partake information) (unaudited)   Three Months Ended June 30, Six Months Ended June 30,

    2019

    2018

    2019

    2018

    Product profits, internet

    $

    519

    $

    -

    $

    519

    $

    -

    Collaboration earnings

    354

    90,000

    819

    90,000

    complete revenue

    873

    ninety,000

    1,338

    90,000

      operating prices and prices: can suffuse of items sold

    forty four

    -

    forty four

    -

    analysis and building

    89,059

    68,980

    175,457

    118,250

    promoting, typical and administrative

    88,227

    43,167

    172,146

    72,016

    total operating charges and expenses

    177,330

    112,147

    347,647

    a hundred ninety,266

      Loss from operations

    (176,457)

    (22,147)

    (346,309)

    (one hundred,266)

    interest profits, web

    eight,220

    5,137

    14,662

    eight,666

    different income, internet

    sixteen

    32

    20

    24

    web loss

    $

    (168,221)

    $

    (sixteen,978)

    $

    (331,627)

    $

    (ninety one,576)

    internet loss per partake - basic and diluted

    $

    (3.28)

    $

    (0.36)

    $

    (6.sixty five)

    $

    (2.02)

    Weighted common shares marvelous - basic and diluted

    fifty one,257,640

    forty six,541,716

    forty nine,882,377

    forty five,439,666

    Sage Therapeutics, Inc. and Subsidiaries Condensed Consolidated stability Sheets (in thousands) (unaudited)   June 30,2019 December 31,2018 money, money equivalents, restrained cash and investments

    $

    1,238,916

    $

    925,143

    total belongings

    $

    1,315,547

    $

    952,705

    total liabilities

    $

    112,672

    $

    89,734

    complete stockholders' fairness

    $

    1,202,875

    $

    862,971

     

    About ZULRESSO™ (brexanolone) injection CIV

    ZULRESSO, the first medicine specifically authorized via the U.S. food and Drug Administration (FDA) for the treatment of postpartum depression (PDD) in adults, is a positive allosteric modulator of both synaptic and extrasynaptic GABA A receptors. Allosteric modulation of neurotransmitter receptor recreation results in varying degrees of favored recreation in preference to comprehensive activation or inhibition of the receptor.

    what is ZULRESSO?

    ZULRESSO™ (brexanolone) CIV is a prescription medication utilized in adults to handle a undeniable ilk of depression known as Postpartum depression.

    important defense assistance

    what is probably the most crucial tips I may soundless learn about ZULRESSO?

    ZULRESSO may antecedent sober facet outcomes, including:

  • extreme sedation and unexpected loss of focus. ZULRESSO can antecedent you to believe very sleepy (excessive sedation) or tide out (lack of recognition). Your healthcare provider should soundless determine you for symptoms of extravagant sleepiness every 2 hours while you are conscious.
  • all through your ZULRESSO infusion, command your healthcare issuer confiscate away in case you believe such as you can not live awake privilege through the time you're constantly unsleeping or if you feel fancy you are going to pass out. Your healthcare issuer may reduce your dose or cease the infusion unless indicators travel away.
  • You necessity to beget a caregiver or loved one with you to advocate keeping for your infant(ren) entire the pass through your ZULRESSO infusion.
  • because of the risk of much harm on account of extreme sedation or unexpected necessity of recognition, ZULRESSO is simply purchasable through a constrained software known as the ZULRESSO REMS.
  • before receiving ZULRESSO, command your healthcare company about entire of your medical circumstances, including in case you:

  • drink alcohol
  • have kidney problems
  • are pregnant or deem you could subsist pregnant. It isn't universal if ZULRESSO will harm your unborn baby.
  • there's a being pregnant registry for females who're exposed to ZULRESSO privilege through pregnancy. The aim of the registry is to assemble advice in regards to the health of ladies exposed to ZULRESSO and their baby. in case you become pregnant privilege through treatment with ZULRESSO, check with your healthcare provider about registering with the countrywide pregnancy Registry for Antidepressants at 1-844-405-6185 or consult with https://womensmentalhealth.org/scientific-and-research-classes/pregnancyregistry/antidepressants/
  • are breastfeeding or design to breastfeed. ZULRESSO passes into breast milk. check with your healthcare provider in regards to the dangers and advantages of breastfeeding and about the most confiscate option to feed your baby whereas receiving ZULRESSO.
  • tell your healthcare issuer about entire the medicines you take, including prescription and over-the-counter drugs, vitamins, and natural dietary supplements.

    ZULRESSO and some drugs can also beget interaction with every different and antecedent sober side outcomes.

    specifically command your healthcare provider if you select other antidepressants, opioids, or vital nervous gadget (CNS) depressants (such as benzodiazepines).

    recognize the medicines you are taking. preserve a listing of them to betray your healthcare provider and pharmacist for those who Get a new drugs. Your healthcare company will select if other drugs can subsist enthusiastic about ZULRESSO.

    How will I receive ZULRESSO?

    ZULRESSO is given to you via constant intravenous (IV) infusion into your vein. The infusion will ultimate for a complete of 60 hours (2.5 days).

    What may soundless I avert whereas receiving ZULRESSO?

  • ZULRESSO may originate you feel dizzy and sleepy. don't drive a motor vehicle or Do different unhealthy actions after your ZULRESSO infusion except your feeling of sleepiness has completely gone away. observe “ what's essentially the most crucial information I may soundless know about ZULRESSO? ”
  • don't drink alcohol whereas receiving ZULRESSO.
  • What are the workable facet results of ZULRESSO?

    ZULRESSO can antecedent censorious facet effects, including:

  • See “ what is essentially the most vital information I may soundless learn about ZULRESSO? ”
  • expanded risk of suicidal innovations or moves. ZULRESSO and other antidepressant drug treatments might also boost suicidal options and actions in some americans 24 years of age and younger. melancholy or other censorious mental ailments are essentially the most censorious factors of suicidal suggestions or actions.
  • How am i able to celebrate forward to and select a celebrate at to preserve away from suicidal thoughts and movements?

  • Pay shut attention to any alterations, above entire surprising changes in mood, behavior, concepts, or emotions, or if you Strengthen suicidal suggestions or actions.
  • tell your healthcare company amend away if you beget any new or sudden adjustments in mood, conduct, recommendations, or feelings.
  • keep entire comply with-up visits along with your healthcare company as scheduled. appellation your healthcare company between visits as mandatory, specially if you beget concerns about symptoms.
  • inform your healthcare company privilege away if in case you beget any of here symptoms, notably in the event that they are new, worse, or subsist anxious you:

  • attempts to commit suicide, techniques about suicide or dying, new or worse melancholy, different queer alterations in habits or mood
  • the most ordinary facet consequences of ZULRESSO include:

  • Sleepiness, dehydrate mouth, passing out, flushing of the dermis or face.
  • These don't seem to subsist the entire side consequences of ZULRESSO.

    call your medical professional for clinical suggestions about facet effects. You may additionally record facet effects to FDA at 1-800-FDA-1088.

    Please observe full Prescribing suggestions including Boxed Warning and medicine ebook for ZULRESSO™ and discuss any questions you may additionally beget along with your healthcare company.

    View source version on businesswire.com:https://www.businesswire.com/information/home/20190806005258/en/

    CONTACT: Investor Contact:

    Maren Killackey, 617-949-4113

    maren.killackey@sagerx.com

    Media Contact:

    Alexis Smith, 617-588-3740

    alexis.smith@sagerx.com

    keyword: united states NORTH the united states MASSACHUSETTS

    trade keyword: BIOTECHNOLOGY other fitness fitness PHARMACEUTICAL

    supply: Sage Therapeutics

    Copyright enterprise Wire 2019.

    PUB: 08/06/2019 06:30 AM/DISC: 08/06/2019 06:30 AM

    http://www.businesswire.com/information/home/20190806005258/en


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