Good afternoon ladies and gentlemen and welcome to the analyst call on the GSK fourth quarter 2019 results. I will now hand you over to Sarah Elton-Farr, Head of Investor Relations, who will introduce today's session..

Thank you. Good morning and good afternoon. Thank you for joining us for our full year 2019 results, which were issued earlier today. You should have received our press release and can view the presentation on GSK's website.

For those not able to view the webcast, slides that accompany today's call are located on the Investors section of the GSK website. Before we begin, please refer to slide two of our presentation for our cautionary statement. Our speakers today are Chief Executive Officer, Emma Walmsley, Iain Mackay, Chief Financial Officer and Dr.

Hal Barron, Chief Scientific Officer and President of R&D. And we have a broader team for Q&A. We request that you ask only a maximum of two questions so that everyone has a chance to participate. Our presentation will last for approximately 45 minutes, lightly longer than usual to give Hal time to update you on our R&D progress.

And with that, I will hand the floor over to Emma..

Thank you, SEF. When I became CEO of GSK in 2017, I laid out my three long term priorities for the company, innovation, performance and trust, all to be powered by a necessary change in culture.

In 2019, we made significant progress across all three of these priorities as we begin to work towards setting ourselves up as two new companies and I will talk more about that in a moment. Our strategy is continuing to deliver results.

You will hear from Hal on innovation and under his leadership, we have strengthened our pipeline, focusing and increasing our investments in R&D with exciting new developments in oncology and a significant number of positive results across the portfolio.

And with strengthened commercial and supply chain delivery, we are showing progress in launch execution in pharma and vaccines. In performance, we have delivered growth across the company with improvements in operational execution as we reshaped the group's portfolio.

In pharma, we continue to invest in our specialty capabilities with talented leaders ready to support the launches we anticipate this year. In consumer healthcare, we completed the transaction we announced at the end of 2018, our joint venture with Pfizer to create a new leading consumer healthcare company.

And on trust, we are also making good progress. We have continued to pioneer innovations in global health in TB, malaria and HIV. And we were delighted to see our performance on our trust commitments reflected in the Dow Jones Sustainability Index where GSK was listed for the first time as a top-ranked company in the sector.

I said the cultural change of GSK is very important. We are also making good progress on this to develop a more performance focused culture with a strong emphasis on ethics and values and we are seeing this reflected in 2019 achievements and our latest employee engagement survey.

In terms of financial results, I am happy that in the year of generic Advair, we saw group sales growth of 8% in CER terms or 4% on a pro forma basis and have delivered adjusted earnings growth of 1%. Sales benefited from a particularly strong performance in vaccines.

Our new products in pharma continue to do well and pro forma consumer sales were driven by a strong performance in oral health. Group operating margins decreased 2.1% on a CER basis to 26.6% as we invested behind our priority pipeline programs with pharma R&D spend up 16%.

The pharma margin also reflects both investing in new products and launch preparation and absorbing the price impact of generic competition in the ICS/LABA class. We are pleased to see margin improvements in vaccines and consumer. On a total basis, earnings per share were up 23% to £0.939 and adjusted earnings per share were up 1%.

Free cash flow for the year was strong at £5.1 billion, although down versus last year as anticipated. And today, we declared a dividend for the fourth quarter of £0.23, resulting in a total dividend for 2019 of £0.80 and we expect to pay £0.80 in 2020. Turning to our new launches.

I am pleased to see sales being driven by new data, further approvals and our improving commercial capabilities under new leadership. In respiratory, Trelegy continues to do well, driven primarily by an increase in U.S. market share. Globally, launches are also doing well and we now have the only once-daily triple therapy for COPD in 44 countries.

We met the primary endpoint of the CAPTAIN study in asthma patients and anticipate U.S. approval in the second half of the year. In asthma biologics, Nucala remains the market leader in total sales and continues to grow well, up 33%, benefiting from the introduction of self administration. The opportunity in this market remains significant.

In oncology, we were delighted to see positive data on all three of our pivotal readouts, Zejula in first-line maintenance therapy of ovarian cancer, belantamab mafodotin in the fourth-line treatment of multiple myeloma and dostarlimab in second-line treatment of the recurrent endometrial cancer.

Hal is going to take you through much more of the detail in a moment, but I am pleased we submitted these data to regulators and look forward to potential approvals later this year. 2019 was also an important year for HIV with a strong flow of positive data that further support the transition we are leading to two drug regimens.

Our new regimens are now growing at a rate that is offsetting the decline in all three drug regimens and we were pleased to see Dovato included in both U.S. and European treatment guidelines at the end of the year.

We continue to lead in HI innovation and are working to bring new therapies to market following the complete response letter related to CMC matters for our long acting two drug regimen, cabotegravir plus rilvipivirin. We are working with the FDA to determine next steps and bring this important treatment option to patients.

Later this year, we also anticipate U.S. approval for fostemsavir, our first-in-class attachment inhibitor for heavily treatment-experienced patients. And finally, in vaccines, Shingrix continues to be a major driver of our growth. We estimate that 14 million patients now have been vaccinated in the U.S.

with at least a dose since launch and plenty of opportunity remains. Our capacity expansion plans for this transformative product in our portfolio are making good progress. We continue to see high levels of demand in the U.S. and we are pleased to receive approval in China where we are planning a phased introduction later this year.

We are very focused on building the pipeline for our next wave of growth and have made significant progress. We have reported positive data on a number of our programs and this year, we have the potential for at least six new approvals, including in oncology, HIV and respiratory.

Last year, we closed transactions with TESARO and Merck KGaA, strengthening our position in oncology further. To help improve our R&D productivity over the longer term, we also initiated alliances to build out our platform technologies in genomics with the University of California and in cell therapy with Lyell.

The overall shape of our pipeline is changing and Hal will talk more to this but given the positive data we are generating, we are confident in investing behind the opportunities we see to support longer term growth.

Also key to the reshaping of the group is the delivery of a successful integration of the Pfizer consumer health business, delivery of synergies from the JV and investing in its future growth. We have a major opportunity to create a new leader in consumer health and to deliver material value to consumers and shareholders.

Since closing the JV at the end of July, we have made rapid initial progress announcing 500 critical leadership roles, completing closes in all major markets and co-locating employees in 31 locations globally so far.

Over the next two years, the integration will continue at speed with the majority of systems and process alignment work to be completed over the next 12 to 18 months. We are building best-in-class capabilities in innovation, digital and retail benefiting from the complementary strengths of the businesses.

And we are building an efficient and effective model to deliver synergy targets and operating margin improvement with a particular focus on overlapping commercial infrastructure and also streamlining the supply chain. In addition, we see considerable opportunity in procurement, logistics, media spend and marketing costs.

Of the £500 million synergies we are targeting we will reinvest up to 25% in our capabilities and portfolio behind the brands and markets with the most promise to generate long term sustainable topline growth. So our first priority remains, as I said many times, to invest in R&D and future growth drivers.

Today, we are also announcing the start of a new two-year program to prepare GSK for separation into two new leading companies, one in biopharma and one in consumer healthcare. Our intention remains to separate the company in around three years from the close of the transaction.

This program will use this unique catalyst to reset the capabilities and cost base of both companies and help support delivery of the significant value creation opportunities we see in both new GSK and new consumer healthcare. Internally, we are calling the program, future-ready.

For new GSK, the program will set up a leading biopharma company with an R&D approach focused on science relating to the immune system, use of genetics and new technologies by driving a common approach to R&D, which will help us be more effective in how we allocate our budget and share technical and scientific expertise to deliver the pipeline regardless of modality.

We will also improve our capabilities and efficiencies in global support functions continuing to simplify processes and systems and considering where our teams are based to deliver a cost base comparing favorably with industry benchmark.

We will continue to simplify and refocus our manufacturing network ensuring our supply chain is specialty ready and continue to improve working capital management, productivity and procurement with a relentless focus on quality, safety and service.

And we will further rationalize our portfolio through divestments to align with our strategic priorities. A number of assets are under review, including our prescription derms business.

For the new consumer healthcare company, this program will support the build of the key technology infrastructure an of course in due course the corporate functions necessary to operate as a standalone company.

While simultaneously, we will continue our work to fully integrate the Pfizer brand and business to deliver our plan synergies and invest in driving future growth.

Using the catalyst of separation, we believe our investment priorities together with our new two-year program, we will set each new company up with strong foundation for future performance. And Iain is now going to take you through some of the financial details behind this.

Iain?.

Thanks Emma. All the comments I make today will be on a constant currency basis except for I specify otherwise and I will cover both total and adjusted results. On slide 12, a summary of the group's results for 2019, which overall were at the upper end of our guidance and demonstrated continued execution on our strategic objectives.

Reported turnover growth was 8%, reflecting closure of the consumer joint venture with Pfizer with group revenue growth of 4% on a pro forma basis.

Total operating profit was up 23% with total earnings per share up 20%, also primarily reflecting reduced management charges and contingent consideration liabilities and put options compared with the previous year.

On an adjusted basis, operating profit was flat and on a reported basis and declined 3% pro forma while adjusted earnings per share was up 1%. I will go through the drivers behind these in more detail in a moment.

We made good progress in the year with free cash flow generating £5.1 billion, reflecting a number of factors, most importantly improved working capital management. And on currency, a weaker Sterling particularly against the U.S. dollar and Japanese yen resulted in a tailwind of 2% on sales and 3% to adjusted earnings per share.

Slide 13 summarizes the reconciliation of our total to adjusted results.

Main adjusting items in the year were intangible amortization with higher charges as a result of TESARO acquisition, major restructuring focused on improving the efficiency of the supply chain, but also some initial charges for the integration of the consumer healthcare JV with Pfizer.

Within transaction related, the main contributor was the unwind of the fair value uplift on inventory taken on as part of the consumer healthcare JV.

And finally, the disposals column includes the proceeds from the divestment of the travel vaccines as well as a gain from the revaluation of the embedded derivative in respect of GSK's exposure to movements in Hindustan Unilever share price. My comments from here onwards are on adjusted results unless stated otherwise.

Slide 14 summarizes the pharmaceutical business where revenues were flat in 2019. Emma has taken you through the performance of some of our key products. So I will just point out a couple of important considerations. Starting with respiratory, sales were up 15% with continued growth from Trelegy and Nucala across all regions.

This was partly offset by Relvar/Breo which declined 13% globally driven by 37% decline in the U.S., reflecting the impact of generic Advair on pricing in the ICS/LABA class. We continue to have good growth expectations outside the U.S. where sales grew 12% in Europe and 19% in international.

In HIV, revenues were up 1% with the dolutegravir franchise up 2% globally. The dynamics in this market reflect the impact of competition as well as a shift within our portfolio towards our two drug regimens with growth in Juluca and Dovato offsetting a decline in Triumeq. At a regional level, dolutegravir grew international and was flat in the U.S.

and Europe. We continue to build momentum with the two drug regimens as access and physician acceptance increases. As the transition in our portfolio continues this year, we expect 2020 revenues for HIV to be broadly flat excluding any material contribution from cabotegravir plus rilpivirine.

Our established pharmaceuticals portfolio declined 8% overall driven by U.S. adverse sales, which were down 56% as expected given generic competition. We expect pricing pressure in the ICS/LABA class to continue. This was offset by continued upside in Ventolin from the authorized generic launched in the U.S.

early in the year, which you will remember is an in-year benefit ahead of the introduction of substitutable generics expected in 2020. We also saw favorable RAR true-ups in the U.S., primarily on Flovent.

Outside respiratory, the remainder of the established pharma portfolio declined by 6% in 2019, in line with our expectation of mid to high single digit decline for the longer term for this part of established products portfolio excluding respiratory.

Overall, we expect to see pharma sales decline slightly in 2020 excluding divestments as the growth of our new product is offset by decline in established pharma. Turning to the operating margin.

We saw a decline in the year informed by an anticipated unfavorable product mix and price impacts including notably the impact of generic Advair as well as non-restructuring related manufacturing facility impairment and a number of legal settlements and importantly, by strategic choices we made to invest in R&D behind priority assets, promotional activity for new launches as well as building specialty capability.

Slide 15 gives you an overview of vaccines performance with sales up 19% driven mainly by Shingrix but also by our meningitis vaccines. Shingrix continues to benefit from our actions to increase the supply capacity with revenues in Q4 of £532 million pounds driven by continued strong uptake in the U.S. as well as in Germany and Canada.

We have been successful in expanding our supply capacity in 2019. Annualizing the Q4 performance with some slight improvements is we believe a reasonable run rate outlook for 2020.

With supply capacity acceleration achieved in 2019, at this time we see limited opportunity for further growth beyond 2020 until we bring our new facility online which we don't expect before 2024. In our meningitis portfolio, which had revenues of over £1 billion in 2019, Bexsero continued to perform well growing 16% with share gains in the U.S.

and strong demand across all regions. The operating margin of 41.4% in 2019 is higher than our medium term expectations due to enhanced operating leverage from Shingrix, positive inventory adjustments and higher royalties.

In the longer term, we continue to anticipate a margin in the mid-30s, as we increase investment in SG&A as we expand Shingrix geographically and in R&D as we invest behind priority assets. Note that we completed the divestment of travel vaccines, Rabipur and Encepur, in December and this had a slight drag on sales growth this year.

Turning to slide 16. Revenues of the new consumer healthcare JV were up 2% on a pro forma basis, despite a drag of around 1% from the combined impact of divestments and the phasing out of low-margin contract manufacturing. We saw good performance from our power brands, particularly in the U.S. and international.

Also, we saw some adverse impact in international during Q4 due to alignment of inventory market levels of some Pfizer brands. In oral health, Sensodyne grew double digits while in wellness, Panadol perform strongly and Advil was continued recovery from historical supply issues.

Respiratory overall had a weaker performance, reflecting a milder cold and flu season earlier in the year. We expect the divestment of the Indian nutrition business to Hindustan Unilever to close around the end of Q1 subject to legal and regulatory approvals.

We are moving forward with other divestments, which will continue through the year and as previously announced, are expected to generate net proceeds of £1 billion from these tail brand disposals which will fund integration and restructuring activities within consumer healthcare.

These disposals along with the Indian nutrition business represented 2019 revenues of approximately £1 billion. We expect to revise the external category reporting structure in place from Q1 2020 to appropriately reflect the key drivers of the combined businesses and we will provide you with details of this ahead of Q1 results.

We are pleased with the progress of the integration with further milestones we to be achieved over the next 24 months and we are very optimistic about the combination of these two portfolios.

The operating margin for the year was 20.8% reflecting the strong ongoing focus on cost control and benefits from restructuring and manufacturing while we continue to increase investment in key brands. On slide 17, we summarize sales and adjusted operating margins. Note that on royalties, these were higher in 2019, driven by Gardasil.

We expect royalties for 2020 to be around £300 million due to reduction in some of the other royalty streams.

I have already covered the drivers behind the other cost lines in some detail and to be clear, we will continue to prioritize investments in R&D to develop our pipeline and customer facing SG&A, building specialty teams and launching new products. Moving to bottom half of the P&L, I would highlight the following.

In interest expense, we continue to see the benefit of our refinancing activities with interest of £810 million which also included a fair value gain on interest rate swaps. We expect an interest expense of between £850 million and £900 million for 2020.

Effective tax rate of 16%, which was slightly better than expected reflects our ongoing progress in settling historic tax matters in key jurisdictions. We continue to expect to see an average effective tax rate of 19% over the medium term, although this will be slightly lower in the near term with our expectation for 2020 at around 17%.

On non-controlling interests, Q4 saw the first full quarter of Pfizer share of profits of new consumer healthcare JV. This will continue through 2020. We remain focused on driving greater cash discipline across the group and generated £5.1 billion of free cash flow in the year, reflecting good progress.

Also, as expected, it was a step down versus 2018 given the impact of Advair genericization.

The key drivers of free cash flow were improved operating cash flow and working capital management as well as a benefit from FX and proceeds from the sale of the travel vaccines, offset by the launch of generic Advair and related phasing of rebates and the upfront payment of €300 million to Merck KGaA.

We expect a step down in 2020 as we pay out higher distributions to non-controlling interests as we see the continued flow-through of rebates relating to Advair and as a result of the separation preparation program we have announced today.

However, we have made great progress in cash flow and working capital management in 2019 and our focus here will continue into 2020. As in 2019, we expect cash flows to be weighted to the second half of the year.

As Emma outlined earlier, we are today announcing a program over the next two years, which will help deliver the value creation opportunities we see within both new GSK and new consumer healthcare.

As we look towards new GSK, we will drive a common approach in pharma and vaccines R&D, further improve our capabilities and efficiencies and support functions and continue simplification of our manufacturing network.

In R&D, our focus is more about building capabilities and a common approach, improving capital allocation across R&D and less about realizing cost savings.

In the support functions, we will drive a leaner organization leveraging recent and ongoing technology investments to improve efficiency, deploy consistent operating models globally and pursue allocation strategy to ensure functions are best placed to support our footprint. In these areas, we will compare favorably with industry benchmarks.

In the pharma supply chain, we have made significant progress to simplify our manufacturing network. We have reduced our manufacturing footprint by 25% over the last three years. Under this program, we will maintain momentum, continue to review our network to ensure it's competitive and adapted to our portfolio.

Taken together, these actions will deliver £800 million of annual savings through a new major restructuring program which has estimated the total cost of £2.4 billion, comprising cash cost of £1.6 billion and non-cash cost of £800 million. This program will be substantially complete by 2022.

We will continue to prioritize allocation of capital within the portfolio through the divestment of non-core assets. And a number of assets including our prescription derms portfolio are under review. We expect the proceeds of divestments to broadly cover the cash cost of delivering new GSK.

This is an important aspect of capital allocation discipline to fund future growth and profitability with greater alignment to our strategic priorities. To set the new consumer healthcare company up for success, we need to build the key technology infrastructure and corporate functions necessary to operate as a standalone company.

We expect to complete the majority of this work in the next two years and our initial estimate of the one-time cost to establish these capabilities is in the range of £600 million to £700 million and will be incurred by the JV.

These will be included in our total results and there is no change to our adjusted operating margin outlook of mid to high 20s in 2022 for the consumer business as we outlined previously. Delivering this two-year program, we will set solid foundations for the future competitive growth and operating performance of new GSK and new consumer health.

Moving to 2020 guidance. On revenues, Shingrix will continue to be a growth driver with some slight improvements on the Q4 run rate being a reasonable guide for our full year 2020 expectation. pharma is expected to decline slightly driven by the established pharma portfolio while our new products continue to make good progress.

And in consumer, the divestments we are targeting will be a drag to topline growth. Our investment priorities remain clear. Given our positive data readouts, we expect to continue to grow our R&D investment at a rate similar to that delivered in 2019 and we will continue to invest in our new launches and building our specialty capability.

Taking these factors into account, we expect adjusted earnings per share in 2020 to be between minus 1% and minus 4% at CER compared to 2019, excluding the impact of any further material divestments. Our guidance today excludes any potential impact of Coronavirus which is yet to be seen.

Whilst we are not providing guidance on 2021 and 2022 at this stage, there are several points I would highlight as you think about the next few years. For Shingrix, at this time we see limited opportunity for further growth in supply capacity until we bring our new facility online which we don't expect for 2024.

In pharma, we do expect an increasing revenue contribution from our new launches. We will continue to grow our R&D investment in 2021 at a similar rate to that in 2019 and we will also continue to invest behind our new launches.

Therefore, overall, we would expect a slight incremental pressure in group adjusted operating margins in 2020 to stabilize in 2021 as we begin to see benefits from the program we have announced today.

From 2022 onwards, we expect to see most of the savings from the program flow through offsetting the increased investment and leading to meaningfully improved operating performance. Our intent to separate the company in around three years from close of the transaction remains unchanged.

As I said, we will pursuing divestments, on which we will keep you informed as we progress. In summary, I am pleased with our performance in 2019 and we will be building on this progress over the next two years.

I am confident that we are taking the right steps to prepare for successful separation, optimizing our operating model to ensure we have the right capabilities and cost bases in place to support investment in future growth and value creation within both new companies. And with that, I will hand over to Hal..

Thank you Iain. It has been approximately two years since I took over as head of R&D and I am very pleased with the progress we have made so far.

Today, I will be focusing on progress we have made over the last 12 months and two key medicines that we feel have great potential to transform how we treat patients, Zejula for ovarian cancer and belantamab mafodotin for multiple myeloma.

In addition, I will briefly discuss other assets that have made important progress in our pipeline and share key milestones for the year ahead. Before I get into my presentation, I want to take a moment to say that I am very excited about the R&D changes Emma mentioned earlier.

I believe that taking a common approach to how we conduct R&D at GSK will help us be more effective in how we discover and develop transformational therapies for patients. With that, let begin my presentation. I would like to start with a brief reminder of our approach to R&D at GSK, which is to leverage science, technology and culture.

Specifically, we are strengthening our R&D pipeline through focus on the science related to the immune system, the use of human genetics and other advance technologies such as functional genomics and machine learning while creating a culture that fosters an innovative mindset.

We made significant progress on this strategy in 2019 and substantially strengthened our pipeline. In the last 12 months, we achieved three major approvals, made eight submissions, had six positive readouts from pivotal studies and progressed four new assets into pivotal study.

Towards the end of my presentation, I will share brief update on our use of human genetics, functional genomics and machine learning to discover new targets. I am also pleased with the progress we are making in transforming our culture in R&D but I will not be focusing on that in today's presentation.

This slide shows the 39 medicines and 15 vaccines currently being developed. It's been a busy year with 20 assets progressing or being added, 14 terminations and three medicines being approved.

As I mentioned, we have also strengthened our late stage pipeline with four new assets progressing into pivotal studies including otilimab for patients with rheumatoid arthritis, bintrafusp alfa for patients with biliary tract cancer, gepotidacin for patients with uncomplicated urinary tract infections and gonorrhea and our ICOS agonist for patients with head and neck cancer.

Notably three of these four potential medicines are biologics. I previously said that we intend to be transparent about the decisions we are taking related to the pipeline. This slide shows our 2019 milestones.

And as you can see, it was a very successful year for R&D with 23 pipeline milestones having positive readouts, including all six pivotal studies. I now want to talk you about the Zejula and belantamab mafodotin, which both had positive pivotal data in 2019 and are expected to bring significant benefits to patients.

In July 2018, I shared how powerful I thought the combination of functional genomics and machine learning could be for R&D, particularly in identifying gene-gene interactions and exploring the concept of synthetic lethality to discover novel targets and improve R&D productivity including identifying which patients are likely to benefit from a given drug.

It was in part based on data generated from this approach that we predicted the PARP inhibitors should work in a much broader population of women with ovarian cancer than those who have the BRCA mutation. In July 2019, the result of the PRIMA study validated our thinking.

While we were confident Zejula would benefit patients with the BRCA mutation, as you can see in the middle panel, Zejula also had a dramatic benefit in BRCA wild-type patients whose tumor had evidence of a homologous recombination defect.

In fact, the benefit in progression free survival was similar to that seen in patients with the BRCA mutation, 11.4 months in wild-type patients versus 11.2 months in patients with the BRCA mutation.

In addition, we observed a clinically meaningful and statistically significant benefit in the homologous recombination proficient, so-called HRP patients, who represent approximately 50% of the overall population.

As you can see from the New England Journal publication of the PAOLA-1 study data, this was not observed with Olaparib where the hazard ratio for this population of patients was 1.0. The PAOLA-1 study hypothesized that combining Avastin with Olaparib would result in a synergistic effect essentially converting HRP patients to HRD patients.

Not only was that not the case, there was no incremental benefit of Olaparib when given with Avastin to HRP patients. So why is Zejula demonstrating this differentiated benefit in homologous recombination proficient patients. Well, one possibility is that Zejula's unique PK profile, which is highlighted in this paper by Sun et al.

The article compares the plasma PK and the tumor PK of both in Zejula and Olaparib in preclinical models. What they found was that at steady-state, there is a 3.3 times greater exposure of Zejula in the tumor xenograph compared to plasma whereas with Olaparib, the tumor exposure is less than plasma.

So where might this manifest? If you look preclinically in the BRCA mutant TNBC model, which you see on the top left here, the two drugs look very similar in terms of their efficacy and both are profound.

When you look at the BRCA wild-type ovarian model on the right, you can see that while Zejula has a statistically significant benefit in terms of tumor growth, this was not observed with Olaparib and that may be related to the concentration of drug in the tumor.

In addition, we had a poster at ESMO which provide a clinical confirmation that there was higher exposure to Zejula in tumor tissue versus plasma in patients with breast cancer. In fact, the data show that the concentration of Zejula was around 36 or greater in tumor tissue compared to plasma.

So to summarize, the PRIMA data demonstrates the value of monotherapy of Zejula for all women with ovarian cancer when given in the frontline setting of maintenance therapy. We have submitted these data in the U.S. having been chosen to participate in the FDA's real-time oncology review pilot program.

In 2019, we also received approval for Zejula of treatment of late stage ovarian cancer based on the QUADRA data and enrollment started for the pivotal MOONSTONE study investigating Zejula plus dostarlimab for platinum-resistant ovarian cancer patients which will actually read out in 2021.

Together, we believe these data will help establish Zejula as the most compelling PARP inhibitors for women with ovarian cancer. In addition, given Zejula's unique PK profile, including its ability to penetrate the blood-brain barrier, we plan to initiate one or two pivotal studies in patients with lung and/or breast cancer by year-end.

Now moving on to belantamab mafodotin, another molecule with a successful 2019. Bela-maf was one of the first assets I highlighted to you back in July 2018. This is our BCMA immuno-conjugate for patients with multiple myeloma. Based on data from a relatively small number of patients, we decided to aggressively accelerate development.

18 months later, we have treated over 550 patients and completed and submitted the pivotal study data in patients with relapsed/refractory myeloma who have failed a proteasome inhibitor, an IMiD and a anti-CD38 antibody, a group of patients who have limited treatment options.

In this patient population, bela-maf demonstrated a clinically meaningful overall response rate of 31% with a 2.5 mg/kg dose and 34% in the 3.4 mg/kg dose. As you can see, the median duration of response has not been reached in either arm at the time of the primary endpoint.

Now DREAMM-2 is the first of our pivotal studies for bela-maf and demonstrates the benefit this treatment could bring to patients with multiple myeloma. As I said, we have successfully filed these data in the U.S.

and Europe and as with Zejula, we are participating in the FDA's real-time oncology review pilot program and anticipate approval in the first half of 2020. As you can see in this slide, a robust development program is in place for bela-maf that will enable us to quickly move into earlier lines of treatment.

We have recently started our front-line pivotal study DREAMM-9 in combination with Velcade, Revlimid and dexamethasone. This study has an initial safety assessment phase to determine the appropriate dose.

DREAMM-7 and DREAMM-8 are our second line pivotal combination studies, which we expect to start this year based on data from the ongoing DREAMM-6 study and the investigator sponsored 418 study. We hope to share data from these two studies at medical meetings later this year.

We are also exploring novel combinations of bela-maf, including with Pembrolizumab in DREMM-4 and with our ICOS agonist and gamma-secretase inhibitor in DREMM-5. I wan to spend a couple of minutes discussing corneal events that we have seen in the bela-maf program, specifically in the DREAMM-2 study.

We take patient safety very seriously and helping clinicians understand and manage this unique adverse event will be important. Here are some facts. 71% of patients were diagnosed with keratopathy, that is a change in the corneal epithelium as seen on an eye exam, of whom about a quarter were asymptomatic.

27% of patients experienced grade three keratopathy and no patient had grade four or grade five keratopathy. 22% of patients experienced blurred vision and 14% expense dry eyes. Among the 95 treated patients, 42 or 44% had no eye symptoms nor clinically significant worsening in their vision.

41 or 43% experienced significant worsening of their visual acuity at some point during the trial, but most of these patients either fully recovered or had meaningful improvement in their visual acuity during the study or during the follow-up period. Importantly, only 1% of patients in discussions with the doctor decided to discontinue the treatment.

Thus keratopathy, although occurring in a little over two-thirds of patients was well-managed by the DREAMM-2 investigators in collaboration with their optho colleague. We have developed educational materials and programs to help ensure that upon launch patients treated with bela-maf are managed optimally.

While I spent the majority of this call discussing Zejula and bela-maf, we also continued to make good progress across our broad pipeline of innovative medicine.

In November, we presented promising data from a Phase 2a study with our novel antisense oligonucleotide for patients with chronic Hepatitis B and we are on track to move this asset into Phase 2b before the end of the year.

In October, we announced the start of our Phase 3 program for gepotidacin, potential first-in-class antibiotic for patients with gonorrhea and uncomplicated urinary tract infections. We expect this Phase 3 data to readout in 2021.

At ESMO in September, we presented data from the INDUCE-1 study showing promising antitumor activity with GSK '609, an ICOS receptor agonist in combination with pembrolizumab in head and neck squamous cell carcinoma.

These data supported initiation of a Phase 2/3 trial called INDUCE-3 to investigate the potential survival benefit of GSK '609 with pembrolizumab in front-line recurrent metastatic head and neck squamous cell carcinoma. INDUCE-3 is designed to have a registrational component, should it pass the Phase 2 interim gate.

And finally, towards the end of the year, the Phase 3 ASCEND program investigating daprodustat for patients with renal anemia was endorsed for continuation by an independent data monitoring committee increasing our confidence in this program.

Daprodustat was filed with the Japanese FDA earlier in the year and we feel increasingly confident about the science behind this potential new medicine and the very robust trials we have designed.

In addition to strengthening the pharma pipeline, we continue to make good progress in vaccine and we anticipate key data this year for two vaccine candidates, one for RSV and one for COPD. In children, respiratory syncytial virus, RSV, causes acute bronchiolitis which can lead to respiratory distress and hospitalization.

In older adults, the infection can cause pneumonia which can also lead to hospitalization.

We have three candidates RSV vaccines, a maternal vaccine which aims to achieve protection during the first six months of life, covering half of the burden of RSV, a pediatric vaccine that will expand that protection for up to two years and lastly a vaccine for older adults.

All three RSV vaccines have fast track designation from the FDA and we anticipate having key data in-house later this year. In addition to RSV, we are also progressing a therapeutic vaccine for patients with COPD. We know that two bacteria, haemophilus influenzae and moraxella catarrhalis, are associated with COPD exacerbations.

So we extracted the functional antigens from these bacteria and combined them with our ASO adjuvant, the same adjuvant used for Shingrix. Initial studies show that the vaccine is safe, highly immunogenic and induces very high functional antibodies against these bacteria.

GSK is the only company moving ahead with a vaccine for COPD patients and we should see proof of concept data by the end of this year. Turning to our approved medicines.

Luke Miels, Chris Corsica, our Head of Development, are all working together to strengthen the collaboration between our commercial and development organizations to make sure we are maximizing the full potential of our medicines for patients. Benlysta is a great example of this.

In late December, we announced headline data from our Phase 3 study in patients with lupus nephritis. Lupus nephritis is an inflammation of the kidneys that occurs in up to 60% of patients with systemic lupus erythematosus and can lead to end-stage kidney disease. This pivotal study met its primary endpoint and all secondary endpoints.

We expect to file these data in the first half of the year and Benlysta could be the first therapy for lupus nephritis to be approved in the United States. Nucala has a growing number of additional indications beyond severe eosinophilic asthma. We received approval for eosinophilic granulomatosis with polyangiitis at the end of 2017.

And now also have positive data in patients with hypereosinophilic syndrome which we expect to file in the first half of this year. We are also expecting to report data from a pivotal study in patients with nasal polyps in the first half of 2020, which we hope will add a fourth indications to Nucala.

And importantly, at the end of December, we dosed the first patient in our pivotal COPD study. Lastly, results from the Phase 3 CAPTAIN study supported the use of Trelegy for the 30% of patients with asthma who were on an ICS/LABA but the continue to expand symptoms. These data were filed with the FDA in October and we anticipate a decision this year.

As I mentioned at the start of my presentation, I want to spend a few minutes updating you on the progress of our efforts to use human genetics, functional genomics and machine learning to find novel and compelling drug targets.

We announced our collaboration with 23andMe in July 2018 and have now identified eight new targets including programs in oncology, immunology, neurology and cardiovascular disease and anticipate one of these projects will enter the clinic later this year.

We have also seen the benefit this collaboration will bring to clinical trial recruitment by successfully identifying and enrolling patients with primary biliary cirrhosis and cholestatic pruritus for a Phase 2 study of our IBAT inhibitor, linerixibat.

A laboratory for genomics research was announced in June with the University of California and is led by the CRISPR pioneers, Jennifer Doudna and Jonathan Weissman. We expect to have the first of our collaborative projects underway in the next few months.

In addition, we continue to attract extremely talented individuals to work in GSK R&D including Erik Ingelsson, previously Professor of Medicine and Genetics at Stanford, who recently joined us as our Head of Human Genetics.

We also now have 50 outstanding scientists across the globe in our AI/ML group and expect this number to grow to about 80 by year-end. I would like to conclude my presentation with a summary of key upcoming pipeline milestones for 2020.

We have a number of potential approvals this year including Zejula in front-line ovarian cancer, bela-maf in fourth-line multiple myeloma, dostarlimab in second-line endometrial cancer, Fostemsavir for patients with HIV, Trelegy for patients with asthma, daprodustat for patients with anemia from chronic disease and cabotegravir plus for our long-acting treatment for patients with HIV.

Pivotal data is anticipated for Nucala in patients with nasal polyps and from the BLISS-BELIEVE study investigating the combination of Benlysta with Rituxan in SLE.

In 2020, we also expect a substantial amount of proof of concept data throughout the year demonstrating the progress of our earlier stage pipeline including data on combination studies with various I-O agents. As I mentioned earlier, we are also looking forward to data on our potential RSV and COPD vaccines.

In summary, I am pleased with the progress we are making to prioritize and strengthen our pipeline, fueled by the increased investment in R&D that Iain mentioned earlier. I look forward to sharing my next update on R&D with you in July. And with that, I will hand over to Emma..

Thanks Hal. So to summarize, in 2019 we delivered a good performance with growth in sales and earnings and strong cash generation. We also made significant progress on all our IPT priorities, strengthening the pipeline, improving operational execution and reshaping the company.

In 2020, our first priority remains innovation and to progress our pipeline and support our new product launches. Recent data readouts underpin our decision to further increase investment in R&D and our long-term growth drivers.

At the same time, we are again focused on operational performance and execution, including delivering a successful integration in consumer health and as we have outlined today with the unique catalyst of the separation we are starting a new program to prepare GSK to become two new companies.

And in trust, we will continue to pursue actions to deliver the public commitments we set out. These support our business and ESG performance and mean that GSK continues to provide a broader contribution to society, in addition of course the financial returns.

All of this aims to support future growth and significant value creation with the formation of two new leading companies in biopharma and consumer, each with the opportunity to improve the health of hundreds of millions of people.

And finally and most importantly, I want to say a big thank you to all our employees and those who worked with us in 2019 for their enormous contribution. Without them, we would not succeed and we count on them now, as we prepare GSK for this exciting future. With that, operator, this team is ready to take your questions..

[Operator Instructions]. Our first question comes from the line of James Gordon from JPMorgan. You are live in the call, James. Please go ahead..

Hello. Thanks for taking the questions. This is James Gordon from JPMorgan. Two questions please. The first question is about consumer because the separation was the theme today. My questions are about the topline outlook.

So pro forma, there wasn't actually any consumer topline growth this quarter and more generally, I think, the market for consumer health is meant to be something like 2% to 3% growth and the players have underperformed a bit.

And more generally, in consumer, there has been some debate from some investors who ask whether consumer companies need to sacrifice some of the increase in the high profitability they have been achieving to invest more to actually to get faster growth.

So is that a valid question for the consumer health business? Is it possible, with that high-20s margins and also an exciting topline growth rate? And then the second question was just on SG&A book for the group.

So I know these various cost saving initiatives and the plan to shift some of SG&A to R&D, but SG&A was actually still up about 3% local currency pro forma.

So is there anything exceptional in Q4? Do we extrapolate that forward to the next few years? That you are not just in investment mode for R&D but SG&A is going to grow quite large as well and that's why no operating margin expansion until 2022?.

Thanks James. I will ask Iain in a moment to comment on SG&A. I think he covered a few of those points previously, particularly on our investment in the future growth drivers but it is worth coming back on the details on non-customer facing. And on consumer, Brian is also on the call.

So I will ask him to comment on the outlook just to reiterate that there were, in terms of Q4 topline, there were a couple of points. One point from divestments and one from alignment of stock levels across the Pfizer portfolio.

And fundamentally, we are still very confident both on extracting the synergies but also on the value that is going to be created by the combination of these two businesses and our investment in growth there. But Brian, would you like to give a bit more commentary on consumer and we will come back to Iain on SG&A..

Yes. Thanks Emma and thanks James. When you look at full year growth for the business, we grew 2%. We did have a 1% drag from divestments and phasing out a low-margin contract manufacturer as we previously communicated. In Q4, we were flat. And as Emma said, we had a point of drag from that and also some alignment of inventory levels.

If you across the portfolio, we still grew healthy on our power brands. We have a very clear strategic resource allocation. We saw mid single digit growth and double digit growth on brands like Sensodyne, Panadol and our gum health brand Parodontax. Now, the integration continues to go well.

We are on track and we are confident in delivering the £500 million synergies. And if you remember, when we communicated, that, we communicated we would invest 25% back of those synergies into innovation and growth.

So as I look at the make up of the business, I still am incredibly excited and optimistic about the combination of the two portfolios, our ability to grow, obviously ex-divestments as Iain laid out and we look at the mid to high 20 margins commitment by 2022, given where we are on integration and our confidence in the synergies, I believe we can also deliver that..

Thanks Brian. Next question please..

No, I didn't answer the SG&A question..

Sorry. No, I wasn't. Iain? Let's go back to SG&A..

Yes, absolutely. James, thanks for your question. I will give just a view on both the fourth quarter as well as the full year on SG&A.

In terms of fourth quarter, it was very much a consistent story around investing around customer facing activities whether it's continuing to build out our own specialty care capabilities but also ensuring the right support behind new product launches and commercial activities.

And that was true across both pharma and the consumer healthcare businesses in the fourth quarter. That's a consistent theme across the whole year. If you look at SG&A for the whole year that was also influenced by a number of legal settlements that we had and that was reflected most importantly in the third quarter.

But when you look at customer facing versus non-customer facing SG&A, both in the fourth quarter and across the year, we have kept non-customer facing SG&A very flat over the course of the year and the quarter and put, if you like, our eggs behind and making sure we have done the right decisions in investment around supporting new product launches and capability in the market..

Thanks Iain. Now, we can go to the next question, please..

Thank you. Your next question comes from Matthew Weston from Credit Suisse. Please go ahead, Matthew. You are live in the call..

Hi. Thank you very much. Two questions, if I can, please. For 2019, I think exactly 50% of pharma business revenue is now established products. It declined 8%.

Could you give us some indication of what we should expect going forward in 2020 and the midterm for that large product segment? And then secondly, Hal, there has been a great deal of investor focus on bintrafusp alfa. I noticed on slide 47, your catalyst that will inform progress, there is no mention of anything in 2021 in terms of readout.

There has been some suggestion of the trial being upsized in front line lung versus Keytruda. Could you just let us know what could drive any decision to upsize the study and whether it really is planned? Thank you..

Thanks. So we will come back to Hal on that in a second and then just ask Iain to comment on established products. So just as a reminder, this is a business or parts of business when we are considering the divestments review and wanting to focus on our core priorities that will be impacted.

And obviously we will update you on that as we go through this execution.

Iain?.

Yes. Matthew, in terms of, you are absolutely right, in 2019, we saw about 6% reduction in the established pharma portfolio over the prior year. And going forward, we would expect a mid to high single digit decline for that portfolio. That, I think, is very consistent with how we have guided and the actual fact how this portfolio has performed.

And just as an aide memoire, we obviously moved adverse Seretide into the established pharma portfolio at the beginning of the year as genericization, loss of exclusivity took place. But broadly speaking, mid to high single digit decline in the established pharma portfolio..

Thank you.

Hal, on bintrafusp please?.

Yes. You know, thank you, Matthew, for the question. We are pleased with the ongoing collaboration with our partners at Merck KGaA on the development of bintrafusp and have been deferring to them on much of the disclosure time lines related to the program. That said, the study is on track for the estimated primary completion at the end of 2021.

We will hopefully be able to have the data read out after that. but remember, that's an event driven trial. And there could be an interim analysis in 2020, which could lead to expansion of the study depending on what's evaluated. No interim data, as we have mentioned before, will be shared externally to protect the integrity of the study.

The data will only be provided once the study is completed and the endpoints are analyzed..

Thanks Hal. Next question, please..

Your next question comes from Andrew Baum from Citi. You are live in the call, Andrew. Please go ahead..

Thank you. Just one question..

Andrew, we can't hear you..

Can you hear me?.

No..

A little louder..

Hello.

Can you hear me?.

Marginally, try..

Yes. So what's the appetite of financial capacity and bandwidth for further BD on the pipeline, given the existing outward pressure required for expansion of the existing program that Iain alluded to in his presentation? Continued growth at the same levels as last year and I assume the same is true for 2021.

Does that allow for additional pipeline products to some in? Or is there still the capacity to do such?.

Thanks Andrew. So heard loud and clear. And the answer on this is, there is absolutely no change to what we have said previously in terms of the prioritization of our capital allocation. Our number one priority is to continue to strengthen the pipeline, be that organically or inorganically.

Obviously, we are particularly pleased with the positive data that's read out more recently and also pleased with the quality of the execution of the business development that we have done to-date.

So we will continue to keep an eye out for that with due alignment to the R&D strategy that Hal laid out and obviously the discipline in terms of some allocation of capital. Next question, please..

Your next question comes from Mark Purcell from Morgan Stanley. You are live in the call, Mark. Please go ahead..

Yes. And I thank you very much for taking my questions. I have two. First on Zejula. How breast and lung cancer starting a new set of trials within the year. Can I just ask, I mean we discussed PARP is potentially the new platinum in the summer of the first half results.

Just why is it taking 18 months before you move into pivotal in these new indications given the set of exciting data you presented today? Is this a case of waiting for internal and additional competitive external data points? Or is this a case of just managing the overall R&D spend? And then secondly on the COPD vaccine, clearly, multi-blockbuster potential.

But I hope could you provide us a little bit of an idea in terms the risk-reward here? When we sort of dig into this and clearly 35%, 45% of patients are persistently colonized by H influenzae and catarrhalis. But if you look at acute infective exacerbations, you will see the involvement of these two bacteria at around about 15%.

So clearly a very exciting program but given the acute exacerbations, you don't see much in terms of overcolonization of these bacteria.

Could you help us understand sort of what kind of signal we could see as we gauge the potentially enormous potential in the latter part of this decade?.

Thanks so much. So I am going to ask, actually Roger Connor spoke about the COPD vaccine. So I think he is on the line with us as well. And then we will ask Hal though, first of all, to comment on the PARP program..

Well, thanks for the question on the PARP and we view this as very exciting class and we think Zejula is very unique, both in its PK and its ability to cross the blood-brain barrier.

One of the our decision with regard to which indications and the design the trials, it was actually not driven really in any meaningful way by competitor data or budgetary constraints.

One of the interesting observations that came out of the PRIMA study which we think we have an explanation for and I went over, is regarding the 50% of patients who had no evidence of a homologous recombination defect to the HRP patients who benefited substantially.

Not only was there improvement in PFS but it's very early days and limited data, but there appeared to be suggestions of maybe even potential survival advantage in an early analysis.

That led us to rethink exactly how to design the trials, which populations to pursue, whether it's treatment, whether it's maintenance and what indications leading us to conclude in lung and breast but the populations within them and how to apply diagnostic with something that we were taking time to digest after PRIMA.

Having said that, we also are trying to take advantage of the potential unique feature of Zejula to cross the blood-brain barrier. So designing trials that might enable us to confirm the preclinical data that suggest it does cross and it is active was important.

So we are excited about getting those programs off the ground and being able to demonstrate significant benefits for those types of patients..

Thanks, Hal.

Rogers, do you want to comment on the COPD vaccine?.

Yes, certainly. Thanks for the question. I would just echo the excitement that we harbor around the development of the COPD vaccine that we have. We are the only company really working in this space. A couple of things just in terms of illustrating the opportunity. First of all, I would say, third largest cause of mortality globally in COPD.

So we think the opportunity is definitely there. In the U.S. alone, we estimate there is around 16 million people suffering from COPD. Obviously, in GSK and the development, we are in vaccines working very closely with our respiratory colleagues in pharmaceuticals because obviously the huge experience that we have as well there are will be key.

And the readout is a proof of concept. As you mentioned, it is going to be in the second half of this year. We are looking at a reduction in acute exacerbation linked to bacterial types. I think in terms of what we expect from the data, I think we will have to see.

What I would point out is that this vaccine does include the same adjuvant technology, our AS01 technology that we have within Shingrix as well. We are expecting to see efficacy data linked to that reduction in moderate to severe exacerbation and we are studying in a population of 40 to 80 year old.

So that said, but we are excited about the opportunity..

Thanks Roger. Next question, please..

Your next question comes from Graham Parry of Bank of America. You are live in the call, Graham. Please go ahead..

Thanks for taking the questions. So, first on is just to clarify the scale and quantity of divestments. So I think you said the amount of revenues that you envisage divesting would be £1 billion in related, say, Horlicks and other consumer divestments.

So can you just confirm the derms and other pharma divestments would be needed in order to cover the £2 billion cash restructuring costs and quantify what you expect lost revenues there to be? And perhaps any EPS dilution on top of your guidance in 2020 that you might envisage from that? And then secondly, when you talk about building R&D capabilities going forward, to envisage that's more weighted towards technologies or products and how do we intend to fund those acquisitions, if external M&A?.

Thanks Graham. I am going to ask Iain to pick up first of all on the shape of the divestments. So just to be clear, the £1 billion was referring to the consumer part of it in terms of net sales including Horlicks. And remember, we previously announced a program of consumer divestments.

So I will let Iain take up on that and then we will come back to Hal on what we mean in terms of building the R&D capabilities through the program, the new program we have announced today..

Yes. Sure, Graham. So divestments, so two buckets here broadly speaking. As Emma described, we had announced earlier at the time that we announced the formation of the JV with Pfizer that we would generate about $1 billion of net proceeds from disposals of tail brands within the consumer healthcare company.

We had obviously announced separately that we would dispose of our Horlicks and certain other brands to Hindustan Unilever which as I mentioned earlier are likely to close, we expect to close some time around the end of this quarter.

Now taking those, the consumer deals together in 2019, that's generated about $1 billion worth of revenue for the topline of consumer healthcare and from the tail brands excluding Hindustan, we would expect to generate $1 billion in net proceeds. That's bucket one.

Bucket two is divestments or assets that are under review across the board pharma portfolio. We mentioned or we announced today the fact that the prescription derms business is under consideration. That's a business, the portion of which we are considering as revenues between £200 million and £300 million. It's a good business.

It's not priority business for us, but certainly it's a good prospect in terms of interest for other people. In terms of the proceeds we would expect to generate from that portfolio reprioritization, we would expect to cover the cash costs of the restructuring program, the readiness for separation of £1.6 billion.

So just for clarity on that, the program we talked about is total cost of £2.4, £1.6 cash, £0.8 of impairments coming through that. And we would expect to generate proceeds that would cover that cash cost. Now within that, also we have mentioned derms as one of the business.

One of the areas we were looking at are also a number of equity holdings that we have which clearly there aren't revenues or operating margins partly attached to and that again represents an interesting opportunity for us to reprioritize capital allocation towards the growth drivers within the organization.

So helpfully, that helps clarify what we are doing. And obviously, as we proceed with these divestments, we will get information to the market about what we are doing and the impacts that has on the ongoing financial of the group..

Thanks Iain.

Hal?.

Yes. Thanks Graham. back So by R&D capabilities, I think I would think about that in three different buckets. First one you mentioned, which is technologies such as AI/ML, functional genomics, human genetics and our cell therapy programs.

I think we have made terrific progress there and advancing them further we will probably be focused on identifying new synthetic lethal combination and some new targets that are already emerging from some of the preliminary functional screens and that combined with, we have already had eight targets from 23andMe, we are just going to have a lot of stuff coming out of the technology that we need to execute on.

So that would be the second bucket as sort of executing on all the emerging data from the technologies. And lastly, capabilities to actually build up the ability to actually get the trials done and filed. The pipeline is very robust now, a lot of successes and we need the people and tools to actually turn all these medicines into approved drugs.

So capabilities on all three of those are where we are focused..

Thanks Hal.

Next question, please?.

Your next question comes from the line of Emmanuel Papadakis from Barclays. Please go ahead. You are live in the call..

Thanks very much. Emmanuel Papadakis from Barclays. Maybe just a couple on the pharma side in terms of potential moving parts in 2020. Congratulations on the PRIMA real-time oncology review.

Could you just share your thoughts in terms of what that might potentially imply in terms of commercial inflection in the second of the year and indeed what is embedded in your current guidance for the pharma business in 2020? And the second one is just on the cabotegravir CRL. CMC, I don't think typically implies huge delays historically.

But you have been rather elusive about clarifying when you expect to refile and the potential ranges around that. So any guidance you could provide would be helpful. Thank you..

Thanks so much Emmanuel. So we will come to Luke first on the commercial outlook for Zejula and then we will come to David, although I am not sure we are going to have definitive answer for you on the progress around the filing for the cab..

Sure. Thanks Emmanuel. Thanks for the question. So as we have communicated in the past, PRIMA really is the critical readout in the near term for this product.

We would expect it in the first half and then linked to that we would expect some changes in the NCCN guidelines, which of course, would then ideally place pressure on this persistent election by some physicians to watch and wait. We are well advanced and prepared for that. We reconfigured the sales force in October.

It has historically been footprint and based on Varubi which is the product that TESARO had for chemo-induced nausea and vomiting. So we took the decision to bite the bullet at that point and reframe the sales force. That's important because around 50% of scripts come from Tier 3 physicians.

It's quite disbursed for oncology, but we would expect to see that flowing through in the second half of next year, once we get the label and the guidelines. Of course, if it comes sooner, we would then update you..

Thanks Luke..

Yes. Thanks Emmanuel. So on cab, the CRL as we said, was entirely related to the CMC, not efficacy or safety or the clinical data. We do think it is definitely resolvable. I am not going to commit right now on time frames. I think we need to meet with the FDA. There is a process for that. It's called the Type 2 meeting and you have to apply and so forth.

But that meeting is likely to happen very soon, certainly during quarter one. And I think when we have that meeting, we would be in a much better position to be clearer on the way forward..

Thanks David.

Next question, please?.

Your next question comes from the line of Geoffrey Porges from Leerink. You are live in the call, Geoffrey. Please go ahead..

Thank you very much. Just a couple of growth drivers questions. First, on Shingrix.

Could you talk a little bit more about the slight supply increase, particularly in the context of the two flat quarters, sequentially flat quarters? And then could also discuss what the pricing trend you would expect over the next couple of years, given the fact that you are moving out of the U.S.

concentrated portfolio into markets such as China? Thanks..

Thanks. Well, I will ask Luke to comment on the pricing dynamic. Although we are obviously thoughtful about that with any geographic expansion, not least because the demand is not showing signs of slowing down. Just in terms of capacity increases though, I would say I am not sure I would agree that we have had two flat quarter on Shingrix.

But with the guidance that we gave today was that we would expect a roll forward of Q4 with a potential slight improvement through 2020. And I am incredibly pleased with the progress that Roger's team has made in terms of capacity expansion, particularly in terms of bulk yield.

And obviously, we are constantly seeing what further opportunities could be possible. But we don't expect much further improvement beyond that until we get into the step change of a new site in 2024, but we will keep you updated as the year progresses.

Luke, you want to comment on second question?.

Sure. Yes. So I mean, we are very focused in terms of mix and markets to introduce. You know, we are in Canada and Germany and we have seen quite striking uptakes there, which are limited by volume like in the U.S. Our approach globally is going to be to introduce this into the private market, at least for a considerable time.

We think there is significant opportunity there in the out-of-pocket segment and that's certainly consistent with what we have seen in Germany. And China is sort of the next one off the bank. What we are trying to do is align the price in these new markets with the U.S. price..

Thanks Luke.

Next question, please?.

Your next question comes from the line of Laura Sutcliffe from UBS. You are live in the call, Laura. Please go ahead..

Hello. Thanks for taking my questions. Firstly on the prescription dermatology business. You mentioned just now that it's a £200 million to £300 million of business in terms of sales.

Could you maybe tell us if you are looking at that as one block as part of the review? Or whether we might see products sold off piecemeal? And then secondly on 916, do you anticipate any patient monitoring requirements for the combination being studied in the DREAMM-9 trial? Thank you..

Thanks. So David, anything to add. I mean I am not sure..

Well, it's early in the review, Laura. So I am not going to get too much in it. I mean obviously we will do whatever we think is in the best interest of the company and the shareholders. As that review goes on, all options are on the table..

Hal, on 916?.

Yes. Thanks, Laura for the question. First, you know, as I said in the presentation, we take patient safety very seriously and helping clinicians understand and manage this unique adverse event will be important.

We are not the disclosing any discussions we are having with regulators but we think that it's going to be important that on the keratopathy that we think was well-managed by the DREAMM-2 investigators in collaboration with their optho colleagues is sort of replicated in the real-world.

We are developing educational materials and programs to help to make sure that happens on launch so that these patients get treated optimally. As we get more clarity with regulatory authorities, we can update you further..

Thanks Hal.

Next question, please?.

Your next question comes from the line of Naresh Chouhan from Intron Health. Please go ahead. You are live in the call..

Hi there. Thanks for taking my questions. One on dividend cover. I remember a while ago, you set some targets around dividend cover and that we see cash flow falling in 2019 is expected to be lower going into 2020.

Can just give us an update on how you are thinking about those targets? And then on the consumer health margin targets, can you help us to understand whether or not you need to have those divestments or potentially or likely lower margin products to help you get to the higher end of that range? Or whether you can hit those targets organically? Thanks..

So I will ask Iain to comment on the consumer margin redivestments.

And I am sorry I forgot, what was the first question?.

The dividend cover..

The dividend cover, yes, sorry. Well, the basic answer to that is we have absolutely no change to our policy around divi cover, which is a function of free cash flow from 1.25 to 1.5 and are actually pleased with the cash flow delivery this year. And we are clear on the policy and clear where it sits on our capital allocation priorities.

Iain, anything on the --.

No change on that front..

I am sorry, Naresh. I am not entirely sure I followed your question, consumer healthcare disposals.

Could you just run that one past me again? Lost him?.

Maybe we can come. Okay, maybe we will go to the next question and --.

Unless Naresh comes, okay..

Next question then, please..

That was your last question..

All right. Well, thank you everybody. We look forward to updating you again soon. Thanks very much..

Thank you Emma. Thank you everyone. That concludes your conference call for today. You may now disconnect. Thank you for joining and enjoy the rest of your day..