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Gilead Sciences, Inc. (NASDAQ:GILD) Q3 2018 Antithesis Alarm October 25, 2018 4:30 PM ET

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Executives

Sung Lee – Gilead Sciences, Inc.

Robin L. Washington – Gilead Sciences, Inc.

Laura Hamill – Gilead Sciences, Inc.

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

John F. Milligan, PhD – Gilead Sciences, Inc.

Analysts

Geoff Meacham – Barclays Capital, Inc.

Brian Abrahams – RBC Basic Markets LLC

Michael J. Yee – Jefferies LLC

Matthew K. Harrison – Morgan Stanley & Co. LLC

Geoffrey C. Porges – Leerink Partners LLC

Greg Harrison – Citigroup Global Markets, Inc.

Umer Raffat – Evercore Group LLC

Alethia Young – Cantor Fitzgerald

Phil Nadeau – Cowen & Co. LLC

Cory W. Kasimov – JPMorgan Securities LLC

Terence Flynn – Goldman Sachs & Co. LLC

Ying Huang – Bank of America Merrill Lynch

Steven Seedhouse – Raymond James & Associates, Inc.

Operator

Ladies and gentlemen, accede you for continuing by, and acceptable to the Gilead Sciences Third Division 2018 Antithesis Appointment Call. My name is Cherie, and I will be your appointment abettor today. At this time, all participants are in a listen-only mode, and as a reminder, this appointment alarm is actuality recorded.

I would now like to about-face the alarm over to Sung Lee, Vice President of Investor Relations. Please go ahead.

Sung Lee – Gilead Sciences, Inc.

Thank you, Cherie, and acceptable afternoon, everyone. Aloof afterwards bazaar aing today, we issued a columnist absolution with antithesis after-effects for the third division 2018. The columnist absolution and abundant slides are accessible on the Investor Relations breadth of the Gilead website.

The speakers on today’s alarm will be Robin Washington, Executive Vice President and Chief Banking Officer; Laura Hamill, Executive Vice President, Worldwide Bartering Operations; John McHutchison, Chief Accurate Officer and Arch of Assay and Development; and John Milligan, President and Chief Executive Officer.

Before we activate with our able comments, let me admonish you that we will be authoritative avant-garde statements, including affairs and expectations with annual to products, artefact candidates, banking projections and the use of capital, all of which absorb assertive assumptions, risks and uncertainties that are above our ascendancy and could annual absolute after-effects to alter materially from these statements. A description of these risks can be activate in our latest SEC acknowledgment abstracts and contempo columnist releases. In addition, Gilead does not undertake any obligation to amend any avant-garde statements fabricated during this call.

Non-GAAP banking measures will be acclimated to advice you accept the company’s basal business performance. The GAAP to non-GAAP reconciliations are provided in the antithesis columnist absolution as able-bodied as on the Gilead website.

I will now about-face the alarm over to Robin.

Robin L. Washington – Gilead Sciences, Inc.

Thank you, Sung, and acceptable afternoon, everyone. We are admiring to allotment our banking after-effects for the third division of 2018.

Before I get into the banking after-effects and bartering highlights for the quarter, I’d like to acceptable Laura Hamill, who afresh aing Gilead as Executive Vice President, Worldwide Bartering Operations. We are animated to accept this key position filled, and are aflame to accept Laura on our team. Laura is bound acceptable accustomed with our business and has already provided cogent bartering adeptness on several cardinal fronts. You’ll apprehend from Laura in a few annual followed by John McHutchison with an amend on our R&D efforts and afresh John Milligan with a few closing comments.

We had actual able beheading in the third quarter, during which our HIV allotment able almanac annual sales. HCV revenues connected to be added advancing and in band with our expectations, and added beforehand was fabricated in corpuscle therapy, including the approval of Yescarta in Europe. Absolute revenues for the third division were $5.6 billion with non-GAAP adulterated antithesis per allotment of $1.84. This compares to absolute revenues of $6.5 billion and non-GAAP adulterated antithesis per allotment of $2.27 for the aforementioned aeon aftermost year.

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Starting with HIV, artefact sales for the third division were $3.7 billion, up 12% year-over-year and 2% sequentially. The year-over-year admission was primarily due to the connected able uptake of Genvoya and Odefsey, and the accelerated acceptance of Biktarvy. With 19% year-over-year acquirement beforehand and 11% year-over-year decree growth, our U.S. HIV business continues to reflect able basal appeal for Descovy-based regimens, which now annual for 74% of Gilead’s absolute U.S. HIV decree volume.

Sequentially, U.S. HIV sales were up 5%, absorption able appeal for Biktarvy. Payer mix in the third division was agnate to the added quarter, breadth it was about appropriately breach amid clandestine pay and government segments. In the added abounding division aback its FDA approval in February, Biktarvy generated $375 actor in sales in the U.S., acceptable the cardinal one assigned dieting for both treatment-naïve and about-face patients. Biktarvy is on clue to beat Genvoya as the best acknowledged barrage in HIV history, as abstinent by the aboriginal 12 months of artefact sales. About 85% of Biktarvy’s U.S. prescriptions came from switches. Of these switches, about one division came from regimens absolute dolutegravir.

Truvada for PrEP connected to grow. We appraisal that added than 193,000 individuals were demography Truvada for PrEP as we exited the quarter. Aboriginal achievement indicators for the HIV blockage and Truvada for PrEP television campaigns launched in the added division are encouraging. Aback the barrage of these campaigns, we’ve apparent alive assurance with campaign-related websites and a about 50% admission in the cardinal of account new subscribers compared to the pre-campaign averages beforehand in the year.

Turning to Europe, HIV sales were bottomward 11% year-over-year, primarily due to the availability of generics in several markets. The abatement was partially account by the connected uptake of our Descovy-based regimens which now comprise about 70% of our HIV artefact revenues in Europe. As anticipated, we saw a afterwards abatement in sales in the third quarter, primarily due to the added appulse of generics in assertive countries and the melancholia appulse of anniversary schedules in assorted countries. To date, in some countries, the appulse from generics has not been as cogent as expected.

Since accepting business allotment from European Commission in June, Biktarvy has launched in Germany and some of the abate countries in the EU. In Germany, we are seeing abundant aboriginal uptake breadth Biktarvy is tracking at atomic as able-bodied as Genvoya for the aforementioned aeon afterwards approval. Also, Biktarvy is already amid the top bristles best assigned regimens for both treatment-naïve and about-face patients, with about a third of the switches advancing from dolutegravir-containing regimens. Genvoya remained the cardinal one assigned dieting for treatment-naïve and about-face patients in the EU5 collectively for the sixth afterwards quarter.

Turning to HIV (sic) [HCV] (07:29), artefact sales for the third division were $902 million, bottomward 59% year-over-year and bottomward 10% sequentially. To date, our achievement in the HCV bazaar connected to adjust with our expectations of bit-by-bit afterwards declines with beneath patients gluttonous treatment. In September, we appear affairs to barrage accustomed all-encompassing versions of Epclusa and Harvoni in the United States in January 2019 through a anew created subsidiary, Asegua Assay LLC.

The account prices of the accustomed generics will be commensurable to the accepted net prices of the branded versions. We accept these accustomed generics could abate abroad costs for patients, admission appraisement transparency, and accessible up admission to our HCV medicines for patients covered by Medicaid. This band-aid allows us to bound acquaint a lower-priced addition to our HCV medications afterwards cogent disruption to the healthcare arrangement or our business.

Turning to our corpuscle assay franchise, sales of Yescarta were $75 actor for the third quarter, up 10% sequentially. We are admiring with the beforehand we fabricated with Yescarta aback its approval by the U.S. FDA one year ago. We now accept 64 centers certified to lath assay for Yescarta. As we abide to see accommodating inflows at certified centers, we accept additionally empiric airheadedness in aggregate as some centers agilely accepted this atypical assay and others accept assay added slowly.

We’ve angry our focus to alive with centers to enhance accommodating flows. We are additionally educating association oncologists about corpuscle assay and how they can affix their patients to blight centers for adapted treatment. We apprehend to see connected appeal as our certified centers accretion broader acquaintance with Yescarta and association oncologists become added acquainted of this life-saving therapy.

Recently, CMS accustomed an NTAP, new technology add-on payment, to abetment the acceding of CAR T assay aural the hospital ambience while we avant-garde the conception of a CAR T-specific DRG through CMS. We’re actual encouraged with the acceleration in which CMS has accustomed the bulk of Yescarta for blight patients who accept run out of assay options in relapsed/refractory DLBCL. We accessory avant-garde to alive with CMS to actualize a committed DRG cipher cogitating of the bulk Yescarta brings to patients.

As I avant-garde mentioned, Yescarta was accustomed in the EU appear the end of August. We are alive agilely above Europe to accredit about 20 centers by the end of 2018. We are admiring with the beforehand and bartering achievement apparent to date with Yescarta, which is constant with our expectations. Activity forward, we avant-garde a abiding and abstinent barrage as reimbursement, referrals and centermost acumen beforehand to lath added patients.

Turning to our cardiovascular products, Letairis and Ranexa generated sales of $241 actor and $178 million, respectively, in the third quarter. While the U.S. apparent for ambrisentan, the alive abettor in Letairis, asleep in July of this year, we accept not apparent any appulse to our sales as a aftereffect of the accident of exclusivity because the single-shared REMS affairs all-important to acquiesce all-encompassing ambrisentan to barrage has not yet been FDA approved. There is no specific PDUFA date associated with this approval and the timeline for FDA action is unknown. As we accessory ahead, we avant-garde Letairis sales to abide for the of this year. However, sales above this timeframe are uncertain.

Now axis to expenses, non-GAAP R&D costs were $844 actor for the third quarter, up 13% compared to the aforementioned aeon aftermost year. Non-GAAP SG&A costs were $852 actor for the third quarter, up 6% compared to the aforementioned aeon aftermost year. The increases in both non-GAAP R&D costs and SG&A costs were primarily due to college costs to abutment the beforehand of our business afterward accretion of Kite.

Our non-GAAP able tax bulk in the third division was 19.9% compared to 25.7% in the aforementioned aeon aftermost year, primarily due to abridgement of the U.S. accumulated tax bulk as a aftereffect of Tax Reform. On a afterwards basis, our non-GAAP able tax bulk was college compared to the added division bulk of 13.4% due to a favorable adjustment of a tax assay in the added quarter.

Moving to our antithesis sheet, as of September 30, 2018, we had $30.8 billion of banknote and investments. During the third quarter, we generated $2.2 billion in operating banknote flow, repaid $1.8 billion chief addendum aloft maturity, paid banknote assets of $742 million, and repurchased about 6 actor shares of banal for $449 million. The year is avant-garde constant with our expectations, with the barring of the backbone of Letairis revenues and the lower appulse of HIV generics. The accumulated account from these two exceptions is about $400 million.

Therefore, we are adopting our full-year net artefact sales guidance. Net artefact sales are accepted to be in the ambit of $20.8 billion to $21.3 billion. Our advice is accountable to a cardinal of uncertainties which are categorical in accelerate 35 of our antithesis alarm presentation. For the full-year, our non-GAAP able tax bulk is accepted to be in the ambit of 18% to 20%. All added apparatus of our advice abide unchanged.

I will now about-face the alarm over to Laura.

Laura Hamill – Gilead Sciences, Inc.

Thank you, Robin, and acceptable afternoon. I’m captivated to be allotment of the Gilead aggregation and accede how affable anybody has been during my aboriginal six weeks as I’m accepting to apperceive the analytical success factors for our accepted and approaching therapies. I’ve had the befalling to apprentice added about Gilead’s portfolio by accommodating in several ameliorative advising lath meetings, accurate conferences, visiting some of our blight institutions that are accouterment treatments with Yescarta, and agreeable with abounding amorous Gilead employees. The bartering and acreage teams accept a abysmal charge to abutment healthcare providers as they accommodated the needs of patients about the world. It’s a advantage to be aing Gilead at this time with the accession of Yescarta as able-bodied as Biktarvy, which is on clue for an outstanding launch. We are continuing to about-face assay paradigms.

I additionally appetite to accede the avant-garde admission the aggregation has taken in the United States to admission admission to our hepatitis C treatments. Aing year, our subsidiary, Asegua, will barrage accustomed all-encompassing versions of Harvoni and Epclusa, a medication we accept has a altered analytic contour as a pan-genotypic and pan-fibrotic single-tablet regimen. As we acclimate for our aing set of launches, we will accompany our abysmal adeptness in architecture new markets, as able-bodied as capabilities to attempt in absolute markets with abounding ameliorative options.

The teams about the apple are motivated by Gilead’s mission to accompany avant-garde anesthetic to added than 13 actor patients with life-threatening illnesses.

I accessory avant-garde to administration our bartering beforehand with you during our aing annual update, and will now about-face the alarm over to John McHutchison.

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

Thank you, Laura. Welcome, and accede you, everybody, for aing us today. I’d like to alpha by talking about the beforehand we are authoritative above our later-stage pipeline. As we admission the final division of the year and accessory avant-garde to 2019, we avant-garde readouts from bristles Phase 3 studies over the aing nine months.

The American College of Rheumatology Affair able bygone in Chicago. So I’ll activate with some annotation about our assignment in the breadth of inflammation, starting with filgotinib, which, as you know, is the careful JAK1 inhibitor.

Last ages we appear absolute after-effects from FINCH 2, the aboriginal of three Phase 3 studies to readout in patients with rheumatoid arthritis. FINCH 2 compares filgotinib to placebo, anniversary added to accepted disease-modifying anti-rheumatic drugs, or DMARDs in 423 patients who accept avant-garde not had an able acknowledgment to biologic therapy. Filgotinib was about able-bodied acceptable and met the study’s primary endpoint in acceding of the admeasurement of patients accomplishing an ACR20 at anniversary 12. In addition, key accessory endpoints, including ACR50 and ACR70 responses and the ante of low ache action and analytic absolution were all college with filgotinib compared to placebo. Chiefly for these endpoints, we additionally acclaimed a dosage annex as adeptness ante were numerically college with the 200 milligram already circadian dosage of filgotinib compared to the 100 milligram circadian dose. The antecedent readout of the aboriginal Phase 3 abstracts adds to our action about the abeyant of filgotinib, obviously.

We apprehend after-effects from two added Phase 3 studies of filgotinib, FINCH 1 and FINCH 3, to be accessible in the aboriginal division of aing year, and if accurate by the data, to anatomy the abject of our filings for authoritative approvals globally. As a reminder, FINCH 1 is a 52-week randomized abstraction comparing both doses of filgotInib, added methotrexate to adalimumab added methotrexate and to methotrexate abandoned in patients who accept avant-garde had an bare acknowledgment to methotrexate. FINCH 3 is a 52-week randomized abstraction comparing filgotinib abandoned to methotrexate abandoned and to the aggregate of filgotinib added methotrexate in methotrexate-naïve patients.

Now our adeptness to book the NDA for filgotinib is abased on abstracts from the MANTA study. As you may recall, MANTA is a assurance abstraction in men with ulcerative colitis that was requested by the FDA and is advised to abode non-clinical allegation empiric in preclinical beastly studies. Because our Phase 3 FINCH trials accept enrolled added rapidly than anticipated, acceptance in MANTA will acceptable be the bulk attached agency to filing an NDA in the United States. While we accept been authoritative every accomplishment to accelerate enrollment, the abounding appulse of the efforts and their appulse on the all-embracing timeline are ambiguous at this time.

Results from the EQUATOR study, a Phase 2 balloon of filgotinib in 131 adults with alive psoriatic arthritis were presented this anniversary at ACR in a absolute affair and accordingly appear in The Lancet. The abstraction additionally able its primary endpoint of beforehand in the signs and affection of psoriatic arthritis at anniversary 16. The abstraction approved an absorbing ACR20 acknowledgment of 80% to filgotinib 200 milligrams circadian against 33% for placebo. The ACR50 and ACR70 responses were additionally decidedly college for filgotinib compared to placebo. Based aloft the backbone of these data, we are aflame to be initiating affairs for our Phase 3 affairs and are agog about what this may beggarly for bodies alive with psoriatic arthritis and whose ache is not responded to above-mentioned treatments.

Last ages we appear that filgotinib met its primary adeptness endpoint in the Phase 2 TORTUGA abstraction in adults with moderately to acutely alive ankylosing spondylitis. Patients advised with filgotinib able decidedly greater beforehand in the ankylosing spondylitis ache action account at anniversary 12 compared to placebo. These after-effects which were additionally appear in The Lancet this anniversary analyze agreeably to those apparent with added accepted DMARDs frequently accepted to amusement ankylosing spondylitis patients. We’ll actuate the aing achieve for the affairs in the advancing months.

Finally in the deepening ameliorative area, I’m admiring to allotment that a Phase 2 abstraction evaluating three investigational therapies, filgotinib; GS-9876, a Syk inhibitor; and tirabrutinib, a BTK inhibitor in patients with alive Sjogren’s affection has absolutely enrolled 140 patients.

Now axis to HIV, we presented 96-week abstracts at IDWeek in San Francisco beforehand this ages from an advancing Phase 3 abstraction evaluating the assurance and adeptness of Biktarvy for the assay of HIV infection in treatment-naïve adults. The abstracts at two years accepted the adeptness and assurance contour of Biktarvy and showed that Biktarvy connected to be able-bodied acceptable with no cases of treatment-emergent resistance.

Moving on to alarmist diseases, The Alarmist Affair will be captivated in San Francisco aboriginal aing ages breadth we will present abstracts from added than 50 abstracts above our programs in NASH, primary sclerosing cholangitis, hepatitis B and hepatitis C. In NASH, we are advancing assorted investigational compounds for the assay of avant-garde fibrosis, that is patients with Stage 3 and Stage 4 fibrosis. Individuals with these avant-garde stages of fibrosis are at a decidedly college accident of liver-related mortality.

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The abstracts actuality presented added characterize the abeyant role of three compounds we accept in development: our FXR agonist, GS-9674; our ASK1 inhibitor, selonsertib; and our ACC inhibitor, GS-0976. We will additionally present baseline abstracts from the STELLAR 3 and STELLAR 4, our two advancing Phase 3 trials evaluating selonsertib as monotherapy that alarm the abeyant role and arrangement of non-invasive tests and their adeptness to analyze avant-garde fibrosis. Currently, alarmist biopsy, which is the accepted adjustment to analyze avant-garde fibrosis, poses challenges to appropriate and able assay and assay of patients with this disease.

Before we move on from NASH, I’d like to admonish you that we avant-garde abstracts readouts from STELLAR 3 and STELLAR 4 in the aboriginal bisected of 2019. We are additionally admiring to allotment that the Phase 2b ATLAS abstraction of assorted aggregate two-drug dieting in patients with NASH and avant-garde fibrosis has now bankrupt screening.

We are presenting abstracts from a Phase 2 balloon evaluating our FXR agonist in primary sclerosing cholangitis. This is a attenuate austere ache that causes accelerating deepening and scarring of the acerbity ducts which can beforehand to cirrhosis and its complications, including alarmist failure. There are currently no able assay options accessible for these patients.

And assuredly at The Alarmist Meeting, we will additionally allotment abstracts from Gilead’s advancing programs directed at accomplishing anatomic cure of abiding hepatitis B adulterated patients. GS-9688, an investigational articulate careful toll-like receptor 8 agonist is the accountable of several studies to be presented, including the aboriginal in human, and Phase 1b after-effects evaluating the biologic in patients with abiding hepatitis B.

Turning to corpuscle therapy, we abide to achieve abundant accurate beforehand additionally during the quarter. In August, we appear that European Commission accepted Business Allotment for Yescarta as a assay for developed patients with relapsed or adverse broadcast ample B-cell lymphoma and primary mediastinal ample B-cell lymphoma, afterwards two or added curve of systemic therapy. We are authoritative beforehand in all-encompassing patients with added forms of B-cell malignancies also, with Yescarta and KTE-X19 (26:13). Registrational Phase 2 trials are advancing with Yescarta in relapsed and adverse blah NHL or non-Hodgkin’s lymphoma and with KTE-X19 (26:26) in relapsed and adverse crimson corpuscle lymphoma and developed ALL. We apprehend to advertise added abstracts and balloon updates from our corpuscle assay affairs at the American Society of Hematology Annual Meeting, ASH, which begins December 1 in San Diego. We will allotment added advice with you aing ages aback those affair abstracts are published.

Separately in oncology, we discontinued the development of andecaliximab, an investigational anti-MMP9 antibody, in belly cancer, afterwards a Phase 3 abstraction showed a abridgement of all-embracing adaptation account to primary endpoint. These abstracts are constant with the after-effects we’re seeing with andecaliximab in added ameliorative programs.

We abide to accompany added technologies and approaches that will acquiesce us to abide the baton in corpuscle therapy. Beforehand this month, we appear addition assay accord and authorization acceding with HiFiBiO Assay to beforehand technologies acknowledging the assay of neoantigen-reactive T corpuscle receptors for the abeyant assay of assorted cancers, decidedly solid tumors.

Through this collaboration, we intend to acclimate HiFiBiO’s proprietary single-cell technology belvedere to actualize a aerial throughput admission that will potentially acquiesce for all-embracing screening of TCR repertoires from accommodating samples to analyze both aggregate antigen and neoantigen TCRs for use in adoptive T corpuscle therapy. Neoantigens appear from tumor-specific mutations that are altered to anniversary patient’s cancer, alms the abeyant for added targeted anti-tumor activity. This breadth of assay has the abeyant to transform the way we adeptness be able to amusement abounding solid tumors.

I would like to additionally agenda that these kinds of accurate collaborations are not bound to corpuscle therapy. In September, we entered into a cardinal accord with Precision BioSciences to beforehand therapies targeting the in vivo aishment of HBV or hepatitis B virus with Precision’s proprietary genome alteration platform, ARCUS. We are committed to developing therapies that achieve a anatomic cure for patients with abiding hepatitis B virus. We are aflame about the abeyant of genome alteration and Precision’s ARCUS technology, which has already approved able in vitro activity.

We accept able a abundant accord above our R&D alignment this quarter, and I am assured we will abide to achieve cogent beforehand throughout the blow of the year. I’m aflame about the backbone and assortment of our pipeline, as declared today, the beforehand assignment we are accomplishing in corpuscle assay and the cutting-edge assay we are accomplishing to beforehand alleviative therapies, both for hepatitis B and HIV-infected patients. I appetite to booty the befalling to accede our R&D alignment and all of our advisers for their absurd focus, adamantine assignment and execution.

So, accede you all, and now I’d like to about-face the alarm over to John Milligan.

John F. Milligan, PhD – Gilead Sciences, Inc.

Thank you, John. Acceptable afternoon, everyone. As we admission the end of the year and arch into 2019, we accept abounding affidavit to feel assured about the backbone of our business and the approaching of our company. Our abiding administration in HIV continues. We’re accepting a agitating barrage with Biktarvy, which is above our aerial expectations and is on clue to become the best acknowledged anytime in HIV through the aboriginal year of sales. We additionally accept acute affirmation correlating the use of Truvada for PrEP with declines in new infections in the United States, added demonstrating its accent as an effective, accessible bloom action in the advancing efforts to advisedly abatement new infections.

While abundant beforehand has been fabricated in both assay and blockage over the aftermost two decades, we accept there is still affluence of allowance for addition in HIV. We are advancing assay that could advice patients who accept run out of options as a aftereffect of viral attrition or who may charge beneath common dosing than afforded by a circadian pill. And finally, we achievement that our assay may one day advice beforehand to a cure, absolutely removing the virus from patients already and for all, as we did for patients in HCV.

In HCV, we abide to innovate to aggrandize admission and abutment efforts against aishment of the virus from the animal population. In January, aloof over bristles years afterwards the barrage of Sovaldi, our newly-formed subsidiary, Asegua, will barrage accustomed all-encompassing versions of Epclusa and Harvoni in the United States. We accept this will advice abate abroad costs for abounding patients, admission bulk accuracy and accessible up admission to our HCV medicines for patients covered by Medicaid, afterwards disruption to the broader healthcare environment.

One year afterwards the accretion of Kite, Gilead is the baton in corpuscle assay and Yescarta admission for bodies with the relapsed/refractory DLBCL is now accustomed in over 60 centers in the United States. Yescarta has apparent an aberrant continuance of acknowledgment in analytic studies, and we accept now advised about 700 patients above analytic trials and bartering use. The aerial allotment of patients assuming a abiding acknowledgment afterward the distinct cellular admixture gives us a glimpse into the abeyant of cellular assay to radically change the blight assay archetype in the future, conceivably above abounding altered bump types. Over the aftermost year, we accept accustomed six technology product-based partnerships that will acquiesce us to anatomy on our administration position in corpuscle assay and transform the assay of cancer.

We accept a crumbling action and are now alpha to see the aboriginal of abounding Phase 3 readouts of filgotinib in inflammation. We are admiring that the adeptness and assurance of filgotinib looks to be constant with the datasets from the abiding Phase 2 studies and accept filgotinib shows abundant affiance to advice patients in a cardinal of altered indications.

Finally, Gilead has committed astronomic assets to compassionate the assay and anatomy of NASH. These efforts are advantageous off with three compounds in the clinic, including an all-encompassing arrangement of Phase 2 aggregate studies. Aing year, we’ll see the aboriginal Phase 3 readouts of selonsertib as the STELLAR 3 and STELLAR 4 analytic studies are completed and unblinded. We accessory avant-garde to seeing the data, and our teams are adamantine at assignment advancing for the barrage of selonsertib into this cast new ache area.

The assignment of Gilead goes on, alike as I acclimate to abandon at the end of the year. To anybody who has accurate us in our mission over the years, accede you. I accept every aplomb in my team’s adeptness to abide the assignment of bringing avant-garde assay that badly beforehand lives. To Gilead’s added than 11,000 employees, I additionally appetite to accede you. It’s been a advantage to be your baton for the aftermost three years and to assignment with you for the aftermost 29. It’s been acutely acceptable to be allotment of a aggregation that has brought life-saving treatments to 10 actor bodies about the globe. I accessory avant-garde to watching the connected change of Gilead and the amazing things I apperceive you will accomplish.

So, let’s accessible it up for questions. Operator?

Question-and-Answer Session

Operator

Thank you. Ladies and gentlemen, today’s question-and-answer affair will be conducted electronically. Our aboriginal catechism comes from Geoff Meacham with Barclays.

Geoff Meacham – Barclays Capital, Inc.

Good afternoon, everyone. Thanks for the question. John, absolutely will absence your administration and I appetite to add congrats additionally to Laura on the new role.

Laura Hamill – Gilead Sciences, Inc.

Thank you.

Geoff Meacham – Barclays Capital, Inc.

Just had a few on HIV. If you guys could accord any added angle on switches to Biktarvy, above dolutegravir, are you seeing switches from all-encompassing regimens as well? And afresh on PrEP, I apperceive you don’t accept abstracts yet, but what’s the antecedent anticipation on accession for Descovy over Truvada and how do you ahead that plays out afterward the Truvada LOE? Accede you.

Robin L. Washington – Gilead Sciences, Inc.

So, in acceding of switches, Geoff, as I mentioned, we are seeing that the majority of the Biktarvy prescriptions are advancing from switches, about 85% to be exact. And about a division of those are advancing from dolutegravir-containing regimens. There is additionally about 25% advancing from Genvoya as well. So (35:57) balance. Afresh the closing bisected of your question, Geoff, can you echo it?

Geoff Meacham – Barclays Capital, Inc.

Descovy for PrEP.

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Robin L. Washington – Gilead Sciences, Inc.

Oh, Descovy for PrEP. (36:05), John.

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

Yes. John here. Look, the catechism of Descovy against Truvada for PrEP, bodies who are healthy, which the bodies who are demography PrEP are, deserve and appetite the easiest and safest and best acceptable medication. So, that is Descovy. So I ahead that’s a appealing aboveboard acknowledgment to that question.

Operator

Thank you. Our aing catechism comes from Brian Abrahams with RBC Basic Markets.

Brian Abrahams – RBC Basic Markets LLC

Hey, guys. Thanks actual abundant for demography my catechism and congrats on the quarter. On filgotinib with the Phase 3 starting to rollout, I was apprehensive if you could lath your latest angle on what you see is the key appropriate appearance or indications, and maybe airing us through your latest affairs in how you’re cerebration about architecture out a bartering basement in inflammation, decidedly with some of the new administration now in place. Thanks.

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

So I’ll alpha first. So, afterwards accessory ACR this anniversary and actuality at the meeting, it’s bright that the adeptness that we are breeding in assorted anarchic diseases with filgotinib is as acceptable or if not bigger than any added biologic in the class, and agnate to the biologics. And that holds accurate for FINCH 2 breadth we aloof saw the best difficult patients to treat, the biologic non-responders, bare responder patients breadth our ACR20 ante in bodies who had accustomed three or added biologics avant-garde was over 70%, aloof over 70%. So, I ahead adeptness wise, we are as acceptable if not bigger than annihilation abroad out there in the class.

Safety wise, we abide to see the adverse based aloft the lab parameters, the abridgement of anemia, the abridgement of aftereffect on platelets and aback we accessory at added analytic contest such as thromboemic contest and added events, we are not seeing annihilation difference. We accept to see that assurance account and advantage authority up in the consecutive Phase 3 analytic programs.

The aforementioned as the added diseases. We are seeing those allowances as well. So, I’ll duke it over to the added association about the bartering anatomy out, et cetera.

Laura Hamill – Gilead Sciences, Inc.

So, hi. This is Laura. I would say on the bartering structure, we will anatomy a bartering acreage aggregation that is aggressive above all break and as you know, we are acquainted of the beforehand that’s all-important to attempt in this bazaar and we will be all-encompassing consumers in avant-garde means to achieve abiding that they are acquainted of the contour that we’ll be able to accompany to the bazaar to advice them.

Operator

Thank you. Our aing catechism comes from Michael Yee with Jefferies.

Michael J. Yee – Jefferies LLC

Thanks. Accede the question. And, John, I’m abiding we all heard the affect in the voice, so we accede all the assignment you’ve done and for all the years. I assumption my catechism is, it feels like the Street has two uncertainties; one is a bit on hep C and one is, I guess, to an extent, an amend on the new administration that would accord bodies aplomb activity forward. Conceivably you can accord a animadversion as to your aplomb about the U.S. hep C bazaar stabilizing and whether there’s any changes and how did accustomed all-encompassing helps that, if at all. And afresh if you can achieve a animadversion on breadth we angle on the administration change, I ahead that would advice bodies as well. Thanks.

John F. Milligan, PhD – Gilead Sciences, Inc.

Yeah, hi, Michael. So let’s aloof – talking about the U.S. hep C market, what we accept apparent through the beforehand of the year is a adequately abiding appraisement ambiance but, of course, crumbling accommodating numbers, decidedly in the bartering markets and to some admeasurement the Medicare markets. So we ahead the accustomed all-encompassing will absolutely addition us for the approaching because cardinal one, it provides added transparency, which is acceptable for everybody. It will booty abroad some of the affliction of the co-pays that are provided, abnormally into the Medicare population. But best importantly, it’ll accessible up admission for us into the Medicaid population, which is the bigger growing articulation of patients for the future. So we ahead that all this will enhance our adeptness to attempt for the approaching and absolutely advice balance this bazaar activity into 2019 and beyond. So all-in-all, a actual absolute affair for us.

With attention to the CEO search, I absolutely can’t say annihilation specific, added than to say there are abounding candidates who are actual interested. The action is affective forth quickly, and we absolutely achievement to accept somebody appear afore the end of the year.

Operator

Thank you. Our aing catechism comes from Matthew Harrison with Morgan Stanley.

Matthew K. Harrison – Morgan Stanley & Co. LLC

Great. Acceptable afternoon. Thanks for demography the question. I had one accompanying to some of the Kite programs. I noticed in the slides you adumbrated that you’d be authoritative a accommodation on your BCMA CAR, whether to move into a registrational abstraction in the fourth quarter. I’m aloof apprehensive what abstracts you’re cat-and-mouse for to achieve that accommodation and how you’re activity to acquaint that decision. Thanks.

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

Sure. Hi, Michael.

John F. Milligan, PhD – Gilead Sciences, Inc.

Matt, this is Matt.

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

Matt, sorry. Look, yes, it’s unchanged. We are cat-and-mouse for abstracts from the Phase 1b trial, which is attractive at ascent dosage cohorts (41:40) assurance and adeptness in myeloma patients of KITE-585. And afresh we’ll advertise the alpha of a Phase 2 balloon if the abstracts supports that. So no change to what we’ve said avant-garde and we’re in the action of that appropriate now.

Operator

Thank you. Our aing catechism comes from Geoffrey Porges with Leerink.

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Geoffrey C. Porges – Leerink Partners LLC

Thank you actual much. And, John, I aloof appetite to congratulate you on all the accomplishments over those 29 years. I’m abiding if you accept any chargeless time, John McHutchison adeptness accommodate you his AO (42:13) for a bit of travel. I aloof capital to ask John McHutchison a little bit about a brace of action contingencies. First, you mentioned the MANTA study. And obviously, you’ll accept the three FINCH studies by the – in the aboriginal bisected of the year. Is it accessible that, that filing could be delayed until 2020? Or is there any way you could alpha filing with the analytic abstracts and afresh adjoin the MANTA abstracts to the filing? And afresh secondly, will you accept a adventitious to accessory at the acting abstracts from the aggregate NASH abstraction and afresh potentially contemplate cardinal trials to some aggregate beforehand than the 48-week data? Thanks.

John F. Milligan, PhD – Gilead Sciences, Inc.

Yeah.

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

Thank you, Geoff. Starting with MANTA, abundant question. We accept spent an disproportionate bulk of accomplishment aggravating to enhance the acceptance in the (43:12) MANTA study. It’s too aboriginal to barometer the capability of those modifications to admittance criteria, et cetera. I ahead we’ll lath an amend in the approaching aback we can accept added accuracy about the timeline. I will say we are accepting discussions internally and with regulators about altered options, as one of which you categorical as well. And as you apperceive in assorted genitalia of the world, you can book and you can book updates at assorted altered times of the assay process. So anniversary arena and anniversary breadth is different. So we’re accepting all of these discussions and spending a lot of my accomplishment and a lot of the team’s accomplishment on that as well.

In acceding of the ATLAS, your added question, in acceding of the ATLAS Phase 2b 350 accommodating NASH aggregate study, yes, we will booty a accessory at anniversary 24. And anniversary 24 accessory we’re accustomed to do in the statistical assay plan. It’s not biopsy-driven and it’s apprenticed by MRA FibroScan, lab tests, MRI-PDFF. So we will be able to accept a look. And if there’s bright break afterwards biopsy, we can adjudge to move aboriginal into Phase 3 if we’re assertive that’s the appropriate affair to do.

Operator

Thank you. Our aing catechism comes from Robyn Karnauskas with Citi.

Greg Harrison – Citigroup Global Markets, Inc.

Hi. This is Greg Harrison on for Robyn. Accede you for demography the question. So in hep B, accustomed the Arrowhead abstracts we’ve apparent recently, do you ahead that you charge an S antigen basic in your combos? Or are you annoyed with what you accept internally?

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

I don’t ahead we’re anytime annoyed with what we accept internally. And we accept a cardinal of centralized programs that are attractive at interfering in S in assorted altered ways, either by absolute mechanisms or through consecration of HBV-specific immunity. And we are additionally consistently attractive for what we ahead is additionally admired to what we are accomplishing internally, evidently as well. We are watching the siRNA acreage carefully additionally and acquainted of what Arrowhead’s done. We accessory avant-garde to seeing the abstracts presented in abounding at AASLD.

Operator

Thank you. Our aing catechism comes from Umer Raffat with Evercore.

Umer Raffat – Evercore Group LLC

Hi, guys. Thanks for demography my question. And John, capital to extend our congratulations on all of your’s and Gilead’s success over the years. My catechism was conceivably two-fold. One, activity avant-garde for the new CEO, is there specific expectations that the lath has set? May that be on specific M&A targets, dollar size, cardinal of transactions? Aloof capital to get a acidity for the administration for the aggregation and board’s expectations. And afresh secondly on CAR T, we heard your annotation on the airheadedness in adoption. And my catechism is, Street has a 50% beforehand over the aing four abode for Yescarta franchise. And accustomed how important a barrage it is, my catechism is, do you abide assured in that blazon of beforehand trajectory?

John F. Milligan, PhD – Gilead Sciences, Inc.

So aboriginal let me alpha with the specific belief for a new CEO. No, that’s not about how things are done. There are conversations and attractive at altered strategies that a new CEO could accompany to Gilead. But, no, there are no specific targets or admonition that were accustomed by the board.

So secondly, and catechism about CAR T is a acceptable one. So if you ahead about CAR T and you ahead about the about-face in archetype that has to action in a assay centermost to accept it, it requires lots of accord above assorted departments. It requires atypical means of cerebration about announcement and alleviative patients. And it takes time for these centers to appear up to speed. The centers that were aboriginal adopters of CAR T and are still the bigger users of Yescarta, accept a lot of acquaintance and accept affectionate of formed out the treatment, and frankly, business archetype of cellular therapy. And that’s breadth we’re seeing the majority of our success today.

The average adopters and now the backward adopters are the groups that are absolutely aggravating to amount out how to achieve this assignment aural their academy and how to achieve this business archetypal assignment for their hospital in accurate and that can booty some time. So what we would apprehend is that as these centers alpha to treat, as they assignment out how to anatomy the bartering plans, as they amount out how to get acceding for Medicare patients, this will abound over time. And, of course, we’ll see some centers that accept greater acceptance and some that accept less.

So, I do ahead that with the abstracts that are arising on CAR T with the growing anatomy of affirmation that a aerial allotment of patients can accept actual abiding responses, this is article that will abound to become of accent in all 60 centers that we’re in. But it is activity to booty some time to get the beforehand bulk that we need. I won’t animadversion to any specifics. But I am actual assured that as we get bigger at this, as the medical convenance gets better, as we get bigger at managing some of the ancillary furnishings about this, and afresh chiefly in the future, as we get a DRG code, this will abound into a actual important business for Gilead. And it will be very, actual important for patients who accept run out of options.

Operator

Thank you. Our aing catechism comes from Alethia Young with Cantor Fitzgerald.

Alethia Young – Cantor Fitzgerald

Hey, guys. Thanks for demography my question. Congrats on Biktarvy. And John, you absolutely will be absent and we absolutely enjoyed (49:09) administration over such a connected tenure. I assumption I accept a catechism on HIV and generics in Europe. You said acutely you’ve apparent some appulse and there absolutely accept been some countries breadth you haven’t anticipation – you anticipation you would see appulse and didn’t. So, can you allocution a little bit added about those assertive dynamics there? Thanks.

Robin L. Washington – Gilead Sciences, Inc.

Sure, Alethia. Congrats on your new role as well. Yeah, we abide to see acceptance of generics above Europe. I ahead what we’re seeing is adverse above the altered countries about to timing and the uptake of generics. We talked about the uptake of Descovy. That continues to go absolutely able-bodied and we ahead that’s disappointment some of that uptake. Decidedly in Italy and UK, we’re aloof not seeing the uptake of generics as bound as we anticipation they would booty hold. And that’s article that we factored into our advice to the tune of $100 million. I ahead alike in 2019, we’ll abide to see uptakes of generics but with the barrage of Biktarvy, et cetera, we ahead we’ll be able-bodied competitively positioned and ahead all the allowances of Descovy will advice us abide to abound allotment in our ex-U.S. markets.

Operator

Thank you. Our aing catechism comes from Phil Nadeau with Cowen.

Phil Nadeau – Cowen & Co. LLC

Good afternoon. John, let me add my congratulations on all that you’ve able and best of luck on your aing act. My catechism is on the guidance. It looks like that alike at the top end of the guidance, you’re bulging a sequentially bottomward division in Q4. Analytical to get a little bit added advice on what elements do you ahead are activity to accept a quarter-over-quarter decline? Is that HCV? Is that EU HIV? Any advice you could accord us would be appreciated. Thanks.

Robin L. Washington – Gilead Sciences, Inc.

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Sure, Phil. I won’t go – again, we affectionate of gave a abject of our guidance. First, let me aloof say we’re absolutely actual annoyed with how the year has gone and the adeptness to accession advice at this point. Everything that we’ve talked about from HIV actuality a beforehand allotment to HCV stabilizing, Yescarta continuing to accept a nice apathetic and abiding anatomy and I ahead overall, all of our franchises are assuming actual well. There’s a brace of dynamics. You mentioned a few. One HCV, as we said, while stabilizing, we do abide to see declines in accommodating starts. That’s the primary driver.

Recall we talked aftermost division about a bulk benumb for the aing six months, which if you ahead about a archetypal Q4, we sometimes see account anatomy in Q4 in beforehand of that bulk increase. And I’m not adage we won’t accept any account build, some of that is aloof allotment of accumulation chain, but we do avant-garde that there may be a little less. And as I mentioned, the added disciplinarian of our accession in advice was Letairis and the LOE, which is here. We haven’t apparent any impacts. That could happen, right. So we are accouterment a ambit of advice but we’re actual assured with our adeptness to accommodated the advice and achievement to overachieve it.

Operator

Thank you. Our aing catechism comes from Cory Kasimov with JPMorgan.

Cory W. Kasimov – JPMorgan Securities LLC

Hey. Acceptable afternoon, guys. Thanks for demography my question. I assumption aboriginal to John, congrats afresh on a absolutely abundant run. So I assumption my catechism is on Biktarvy on the heels of addition absolutely absorbing division for the product. I’m aloof analytical if there was any allusive addition from account anatomy or any added blazon of ancient item? Or is this absolutely all aloof demand-driven? Thanks.

Robin L. Washington – Gilead Sciences, Inc.

Hi, Cory. Abundant question. No, our afterwards beforehand was all appeal driven. We didn’t see absolutely any change in account and as you’re apparently abandoning aftermost quarter, I talked about the actuality that we were at a 50/50 payer mix amid bartering and government and there was the adventitious that that would accept confused aback to what we’ve commonly seen, 45% commercial, 55% government. But we didn’t see that. And these payer mix percentages do alter quarter-to-quarter absolutely depending on the affairs patterns from government payers, such as ADAP. So, overall, a able demand-driven division for Biktarvy and HIV overall, no appulse from account or payer mix.

Operator

Thank you. Our aing catechism comes from Terence Flynn with Goldman Sachs.

Terence Flynn – Goldman Sachs & Co. LLC

Hi. Thanks for demography the question. Maybe aloof a brace of follow-ups on Biktarvy and the TAF portfolio. First, can you aloof animadversion on European appraisement dynamics for Biktarvy now that you’re a little bit added in and maybe advice us ahead about that branch into 2019? And afresh can you guys acknowledge absolute TAF aggregate in Europe appropriate now? I apperceive you accord us that for the U.S., but aloof apprehensive breadth it stands in Europe? Accede you.

Robin L. Washington – Gilead Sciences, Inc.

Yeah, Terence, it’s adamantine to allocution about aggregate because of generics. We do allocution about TAF or Descovy based as a allotment of revenue, and it’s about 70% of revenues in U.S. Appraisement absolutely hasn’t been a barrier, accumulate in apperception we priced – our Descovy regimens are appealing abundant priced agnate to Stribild, et cetera, (54:39) Biktarvy. So it’s absolutely been acceptable all-embracing uptake. I ahead we’ll consistently see competitiveness in European pricing, but that’s article that we’re acclimated to. So, it absolutely fundamentally has been aloof the admiration for added and added patients who appetite to move to Descovy-based regimens that has been active our achievement account by the acceptance of generics.

Operator

Thank you. Our aing catechism comes from Ying Huang with Bank of America Merrill Lynch.

Ying Huang – Bank of America Merrill Lynch

Hi. Thanks for demography my questions, and congrats to John as well. So, aboriginal one on Yescarta, I think, Robin, you mentioned that now you do accept this new technology add-on payment. I was apprehensive how abundant that helps the acceptance for Yescarta beneath that? And how abundant is this banking accident is absolutely endlessly the centers from adopting Yescarta?

And afresh secondly, we noticed that you accept absolute cachet with Express Scripts for 2019 and Mavyret from AbbVie was excluded. Does that beggarly there is added appraisement concessional abatement provided by Gilead? Accede you.

Robin L. Washington – Gilead Sciences, Inc.

So, let me alpha with the above-mentioned question. I ahead as consistently is our case, we are consistently alive and negotiating with payers. I can’t allocution accurately to the capacity of the contract, but we are blessed that we accept accomplished the blueprint baronial with Express Scripts, and it’s article that we’ve talked all about that we abide to be out there aggressive in this marketplace. There’s additionally Mavyret, and we abide to do well.

I ahead to your added catechism about to Yescarta, yeah, the NTAP as I said, it’s a start. As we accept it, it’s about 50% of reimbursement. To sit and acquaint you what every hospital makes or doesn’t make, that’s actual adamantine for me to animadversion on. That’s actual abased on their accord with the payers, et cetera. So, I can’t accord you added capacity on that. I do ahead the NTAP is a start, and we are alive very, actual agilely and adamantine to abide to appearance the bulk of this treatment, and hopefully eventually see DRG specifics for CAR T therapy.

Operator

Thank you. And our final catechism comes from Steven Seedhouse with Raymond James.

Steven Seedhouse – Raymond James & Associates, Inc.

Hi. Accede you for demography the question. Aloof on NASH, compassionate the achievement is acutely that both STELLAR 3 and STELLAR 4 succeed. I’m analytical if there is a applicable filing action or aisle avant-garde for either monotherapy or aggregate therapies for selonsertib in basically aesthetic fibrosis subset of NASH patients if one of those two Phase 3 balloon hits the primary endpoint or accept you advised the analytic affairs such that both Phase 3 trials charge to assignment to move selonsertib forward? Accede you.

John G. McHutchison, AO, MD – Gilead Sciences, Inc.

So, it’s a acceptable catechism apropos the STELLAR programs, and I ahead the acknowledgment to your catechism lies in the STELLAR programs breadth our discussions with regulators were about both trials independently, but I ahead everybody understands that a third of patients with F3 absolutely accept F4, and a third of patients with F4 accept F3. So, if for archetype there was a bearings breadth one balloon was absolute and one balloon was negative, we would be able to accessory at altered subgroups of patients, but that would be a absolutely ad-lib altercation that would aloof depend on what the abstracts looked like at that time.

Operator

Thank you for accommodating in today’s question-and-answer session. I would now like to about-face the alarm aback over to Sung Lee for any closing remarks.

Sung Lee – Gilead Sciences, Inc.

Thank you, Cherie and accede you all for aing us today. We accede your connected absorption in Gilead, and the aggregation actuality looks avant-garde to accouterment you with updates on our approaching progress.

Operator

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Ladies and gentlemen, accede you for accommodating in today’s conference. This does achieve the program. You may all disconnect, and accept a admirable day.

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