Vectura Group Live Discussion

Live Discuss Polls Ratings Documents

Ripley94 28 Oct 2019

Topped up VEC… XXXX Not been lucky with this sector at all , Was looking @ BIIB ( Alzheimer , “come back news” had a big recent rise ! ) Big boys obviously aware of news before. & VRTX ( Cystic Fibrous … NHS deal )… both on main news Friday 25th October 2019.

Ripley94 22 Oct 2019

Topped up VEC… XXXX E-mail ( W ) Consolidation just done money paid on 25th Oct .

Ripley94 09 Oct 2019

Topped up VEC… XXXX Return of capital ( 6p per share ) Consolidation 12p for 13p.

d_gaser 17 Jul 2019

V.E.C up date look plus returning £50m to shareholders update Chippenham, UK - 17 July 2019: Vectura Group plc (LSE: VEC) (“Vectura” or “the Group”) today confirms its R&D investment priorities, announces a proposed £50 million capital return and provides an unaudited pre-close trading update. Paul Fry, Interim Chief Executive Officer of Vectura, commented: "Vectura has a rich heritage in developing innovative inhaled drug delivery solutions and we believe we provide a differentiated offering to partners. We see an attractive, growing market opportunity for these services, and this is where our focus is set for the future. Today we are confirming that our R&D investment priorities will be clearly aligned to this partnering focus. "Given the Group’s focus is now primarily on organic growth, with lower risk R&D spend supported by partners, it is our intention to return £50 million to shareholders this year, with the Board continuing to review our capital allocation strategy on a regular basis. “Vectura made a positive start to trading during H1 2019, with flutiform® product supply revenues making an important contribution to growth. We are pleased to be able to re-confirm our financial guidance and outlook expectations for 2019.” R&D investment priorities Vectura is a provider of innovative inhaled drug delivery solutions that enable partners to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies. Following the successful build out of its generics portfolio, Vectura will continue to focus on securing new partner contracts for the development of inhaled therapies, including novel molecules. For these contracts the Group will move towards offering development services where a smaller proportion of the overall contract value is delivered through contingent milestones. The Group will continue to invest in new proprietary platform technologies, creating intellectual property to drive future licensing and royalty income. In 2018, the Group invested approximately 55% (c. £30 million) of its total R&D spend in platform technologies and existing partnered programmes. The R&D investment that has historically been focused outside these priorities will be progressively re-deployed towards new partner contracts. Return of capital In light of the Group’s reducing R&D risk profile, future cash generation expectations and strong cash balance, the Board has approved, in principle, a capital return of approximately £50 million, commencing in 2019. The proposed return of capital is currently expected to be structured as a tender offer, although the Board continues to review other options. Further details regarding the specific mechanism for, and the timing of, the return of capital will be provided at the time of the Group’s interim results in September. The Board recognises that considerable financial upsides remain in the outlook for the Group, and, in the absence of future inorganic growth opportunities, it intends to make additional future ‘special’ returns of excess capital arising from operations or from material one-off events, by the most appropriate mechanism. Current trading and outlook Vectura made a positive start to trading in 2019, with flutiform® in-market demand and partner supply chain management resulting in product supply revenues being ahead of the Board’s expectations for H1 2019. Given the Group’s visibility of flutiform® product supply volumes for the rest of 2019, the Group expects this strong performance to continue into the second half of the year. Following a constructive end of Phase II meeting with the FDA in May, Vectura continues to seek a partner for VR647 Phase III development and commercialisation. Irrespective of the outcome of these discussions the Group maintains its financial guidance and outlook expectations for 2019.

d_gaser 24 May 2019

Vec recieves £2.5 on European Market submission of QVM149 0700 +010: $2.5m milestone payment for QVM149 submission RNS Number : 0548A Vectura Group plc 24 May 2019 Vectura receives $2.5m milestone payment for the European regulatory submission of QVM149 BE HAPPY Dave Chippenham, UK - 24 May 2019: Vectura Group plc (LSE: VEC) (“Vectura” or “the Group”), announced today that it will receive a $2.5million milestone payment under an exclusive licence agreement with Novartis AG. The payment was triggered following the acceptance of Novartis’ valid Marketing Authorisation Application (MAA) by the EU Regulatory Authorities for the regulatory approval of QVM149. QVM149 is a potential new inhaled combination therapy for inadequately controlled asthma. Vectura’s Chief Executive Officer, James Ward-Lilley, said: “We are pleased to see the progression of the QVM149 program and the acceptance of the EU registration dossier ahead of its original timeline. Based on the strong Phase II study results for QVM149 presented at ATS this week, we believe this new asthma treatment has the potential to have a competitive profile and provide an important and compelling additional option for physicians and patients.” QVM149 combines comprehensive bronchodilation of indacaterol acetate (a LABA [long-acting beta agonist]) and glycopyrronium bromide (a LAMA [long-acting muscarinic receptor antagonists) with mometasone furoate (an inhaled corticosteroid) in a precise once-daily formulation delivered in a dry-powder inhaler device. Vectura and Sosei Heptares exclusively licensed glycopyrronium bromide and certain intellectual property relating to its use and formulation to Novartis in April 2005. Novartis is responsible for the development and commercialisation of QVM149. Vectura is due to receive a further milestone payment of $5.0 million on European regulatory approval of the product and thereafter royalties on net sales from launch.

d_gaser 22 May 2019

Novatis release results for QVM149 dry powder asthma treatment Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inhaled treatment • New inhaled combination for asthma treatment (indacaterol acetate, glycopyrronium bromide and mometasone furoate - IND/GLY/MF) was superior to the standard of care (long-acting beta-agonist/inhaled corticosteroid - LABA/ICS) in terms of lung function in a phase II study • In another phase II study, IND/GLY/MF was superior to placebo in lung function improvement irrespective of administration time of morning or evening • The combination of IND/GLY/MF is in development as a once-daily inhaled treatment for asthma, delivering the comprehensive bronchodilation of indacaterol/glycopyrronium and the established efficacy of mometasone via the dose-confirming Breezhaler® • IND/GLY/MF demonstrated a favorable safety and tolerability profile in both phase II studies Basel, May 22, 2019 - Novartis announced today that new phase II data for IND/GLY/MF (QVM149), an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate, delivered with the dose-confirming Breezhaler® inhalation device, was presented at the 2019 annual international congress of the American Thoracic Society (ATS). In two phase II clinical studies, IND/GLY/MF was superior to the comparators, salmeterol/fluticasone propionate (a standard-of-care treatment)[1] and placebo[2], separately by demonstrating improvement in lung function in patients with asthma. In one study, IND/GLY/MF also demonstrated improvements versus placebo irrespective of administration time of morning or evening[2]. In the phase II CQVM149B2208 study ( Identifier: NCT03063086), both once-daily doses of IND/GLY/MF (150/50/160 Mu g, high-dose ICS; 150/50/80 Mu g, medium-dose ICS) met the primary endpoint with statistically significant improvements of peak FEV1 (forced expiratory volume in 1 second) versus twice daily salmeterol/fluticasone propionate (50/500 Mu g, high-dose ICS) with mean differences of 172 mL (95% CI: 137, 208) and 159 mL (95% CI: 123, 195), respectively (p<0.001)[1]. Additionally, compared with salmeterol/fluticasone propionate 50/500 Mu g twice a day, both high and medium doses of IND/GLY/MF met the secondary endpoint with statistically significant improvements (p<0.001) in FEV1AUC (FEV1 area under the curve) across both time intervals of FEV1AUC5min-1h and FEV1AUC5min-23h45min[1]. “These results demonstrate that this novel combination offering dual bronchodilation plus an inhaled corticosteroid can provide further lung function benefits to patients with asthma beyond established therapies,” said Dr Henrik Watz, Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research. In study CQVM149B2209 ( Identifier: NCT03108027), once-daily IND/GLY/MF provided consistent and substantial lung function benefits over the entire 24-hour dosing interval in adult patients with asthma, irrespective of dosing time (morning or evening). The study met the primary endpoint by demonstrating the improved FEV1 for both morning and evening administrations of IND/GLY/MF versus placebo over 14 days, with mean differences of 610 mL (90% CI: 538, 681) and 615 mL (90% CI: 544, 687) respectively[2]. The safety data from both studies suggest that IND/GLY/MF has a favorable safety and tolerability profile. The adverse events observed in the IND/GLY/MF groups were comparable to placebo (CQVM149B2209)[2] and salmeterol/fluticasone propionate (CQVM149B2208) [1], with no serious adverse events reported in any treatment period in both studies. While phase III trials are ongoing, Novartis plans to present more data and analyses at future medical conferences to address the clinical and regulatory path forward for IND/GLY/MF delivered by Breezhaler®. “Despite the availability of numerous asthma treatments, more than one-third of asthma patients remain uncontrolled and continue to experience symptoms and/or exacerbations,” said Linda Armstrong, MD, Respiratory Development Unit Head. “These phase II studies’ results are a promising stride forward for this once daily combination. Together with a dose-confirming Breezhaler® inhalation device, which is well established in COPD, this new combination, if approved, has the potential to improve lives of those with uncontrolled asthma.” About QVM149 (IND/GLY/MF) The combination of indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF) is currently in development for the treatment of inadequately controlled asthma. This formulation combines comprehensive bronchodilation of indacaterol acetate (a LABA [long-acting beta agonist]) and glycopyrronium bromide (a LAMA [long-acting muscarinic receptor antagonists]) with mometasone furoate (high- or medium-dose ICS [inhaled corticosteroid]) in a precise once-daily formulation, delivered with the dose-confirming Breezhaler® device. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura. Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA, for use in QVM149 (Worldwide excluding US).

d_gaser 07 May 2019

Vec win £89m + against GSK It appears VEC have won their litigation against GSK in the US courts, and have been awarded £89m in partial damages up to 2019 . How ever further awards could be awarded ,as the court found GKN infringed VEC Patents wilfully and deliberately, That means VEC could double this award as the infringement will still carry on until 2021 .GKN may come to an out of court settlement . BE HAPPY DAVE

Ripley94 05 Apr 2019

Topped up VEC… XXXX Bed & Isa 73.71 / 73.62 Dropped in my favour not speedy took 45mins.

d_gaser 03 Jan 2019

VEC up date looks good ,shares up 12.33% in morning trading 0700 +000: Pre-close trading update confirms good progress RNS Number : 0203M Vectura Group plc 03 January 2019 This contains inside information Pre-close trading update confirms good progress against 2018 goals Chippenham, UK - 03 January 2019: Vectura Group plc (LSE: VEC) (“Vectura” or “the Group”) today announces an unaudited 2018 pre-close trading update. The Group expects revenue to be in line with, and EBITDA to be materially above, current market consensus expectations. Vectura will report its preliminary results for the year ended 31 December 2018 on Tuesday 26 March 2019. Highlights: •Vectura revenues continue to grow in line with expectations, underpinned by positive in-market sales performance of: o flutiform® total in-market sales[1] were up 8.6% for the 12 month period to September 2018 - Europe +3.7%, Japan +13.9% and rest of world (ROW) +19.7% - all at constant exchange rates (CER) compared to the 12 months to September 2017 o Ultibro® total in-market sales1 were up 12.2% for the 12 month period to September 2018 - Europe +9.7%, Japan -0.8% and ROW +27.3% - all at CER compared to the 12 months to September 2017 •Agreement signed with Hikma pharmaceuticals for the global development and commercialisation of generic versions of GSK’s Ellipta® portfolio, receiving an upfront milestone of US$15 million •Continuing to build and progress generic pipeline, including the Ellipta® portfolio, VR315 and VR2081 •Significant progress on nebulised portfolio, despite disappointing VR475 results, including positive VR647 Phase II data and the development of three new Vectura enhanced therapies, targeting niche or orphan disease segments •R&D transformation successfully creating capacity to support new programmes as well as cost efficiencies •Strong operational performance delivering EBITDA growth materially ahead of market expectations, with closing cash and cash equivalents of approximately £108 million James Ward-Lilley, Chief Executive Officer of Vectura, commented: “Vectura has made good progress in the year with positive top line performance, pipeline evolution aligned with our refocused investment strategy, and strong operational execution. We look forward to 2019 with key news flow on VR315, partnering of VR647, further disclosure and momentum on our new Vectura Enhanced Nebulised assets as well as Phase III results from QVM149, our inhaled triple combination therapy for asthma, partnered with Novartis.” Financial guidance The Group maintains its guidance that it expects to meet 2018 consensus revenue growth expectations. Adjusted EBITDA is expected to be materially ahead of market consensus expectations, due to overall revenue mix, productivity initiatives and margin improvements. The Group expects its R&D investment for the full year 2018 to be at, or around, the bottom of the £55 million to £65 million guidance range. Our 2019 guidance for R&D expenditure remains unchanged at £45 million to £55 million. Pipeline progress Inhaled generics Open-Inhale-Close dry powder inhaler device On 8 November 2018, Vectura signed a global agreement with Hikma for the development and commercialisation of generic versions of GSK’s Ellipta® portfolio, utilising Vectura’s proprietary Open-Inhale-Close (OIC) dry powder inhaler device, receiving an upfront milestone of $15 million. The new OIC development programmes are underway. VR315 (Hikma, US) Recruitment is progressing well on the repeat clinical study for VR315, and Hikma anticipates being able to submit data from the study to the US Food and Drug Administration (“FDA”) during 2019 to support its regulatory application, enabling a potential US launch in 2020, as previously communicated. VR2081 (Sandoz, US) Vectura is continuing its pMDI development work on VR2081, a generic version of an existing major inhaled combination therapy for asthma and COPD in the US, with the first clinical trial batches delivered to the Group’s partner Sandoz. VR410 (Pulmatrix, US) VR410 is a branded generic alternative to Spiriva® HandiHaler® (tiotropium bromide) in the US. Following a review of our generic pipeline priorities, Vectura and Pulmatrix have mutually agreed to terminate the agreement and cease further development of this project. Vectura Enhanced Nebulised Technology VR647 (Paediatric asthma, US) On 21 August 2018, two positive studies were completed; (Pharmacokinetic and Usability) supporting progression to a Phase III development programme. The Phase III study initiation is planned in 2019, following an end-of-phase II consultation with the FDA. As previously indicated, the Group will seek to partner VR647 development and commercialisation during 2019. VR475 (Severe adult asthma, EU) On 26 November 2018, Vectura announced that its Phase III study of VR475 in adult and adolescent patients with severe uncontrolled asthma did not meet its primary endpoint and the Group would not be pursuing further development and partnering of the programme. Whilst the primary endpoint did not achieve statistical significance, positive trends and clinically meaningful differences between VR475 and placebo, and versus conventionally nebulised budesonide, reinforce the differential characteristics of Vectura’s guided inhalation system versus conventional nebulisation. These data support our confidence in Vectura’s nebulised platform, including the ongoing VR647 programme, as well as the three additional earlier stage nebulised programmes using non-budesonide molecules. New VEC enhanced nebulised therapies (VeNT) programmes Vectura is progressing three new pipeline projects based on combining existing proven molecules with our proprietary breath controlled nebulised technology. These assets are targeting niche or orphan disease segments in multi-billion US dollar markets with individual peak year sales potential in excess of US$250 million, and are being developed for the inhaled management of cardiopulmonary vascular disease, cystic fibrosis and infection in post-transplant immunocompromised patients. Vectura will outline progress on these programmes during 2019. VR465 (Ablynx, ALX-0171 anti-RSV nanobody - a Sanofi Company) The results of the Ablynx ALX-0171 anti-RSV nanobody Phase II programme were positive for the primary endpoint of anti-viral efficacy and target exposure was achieved; however, consistent clinical efficacy was not observed across secondary endpoints. Sanofi has deprioritised this programme and is not continuing with it. Attendance at 37th Annual J.P. Morgan Healthcare Conference Vectura will be attending the 37th Annual J.P. Morgan Healthcare Conference, 7-10 January 2019 in San Francisco, California. James Ward-Lilley, CEO, will give a presentation at 9.30am PT on Thursday 10th January. Ends-

d_gaser 13 Dec 2018

VEC loose U.K patent dispute with GlaxoSmithKline PLC Vectura Group PLC (VEC.LN) said Thursday that a U.K. court ruled against it in a patent dispute with GlaxoSmithKline PLC (GSK.LN). The judgment related to a 2010 patent agreement between Vectura and GSK over Ellipta-branded products for lung disease and asthma. Vectura said it was disappointed by the ruling and will consider its options, including seeking permission to appeal. Vectura said it doesn’t believe the result will materially affect proceedings in the U.S. related to the same patent agreement. Shares at 1242 GMT were down 1.60 pence, or 2.2%, at 71.05 pence. We Want to Hear from You Join the conversation Comment MarketWatch Partner Center Most Popular

Ripley94 26 Nov 2018

Topped up VEC… XXXX Went to 79p on the 8th November , but back down @ 68p today there is a court case going on . The swing is 15 %

wilko_my_boy 05 Oct 2018

Investors Cronicle Can anybody copy IC article to discussion

Ripley94 13 Sep 2018

Topped up VEC… XXXXX 12 % lower then by back. 68.5p 21st March 2018

Matal 12 Sep 2018

Interim Accounts .Revenue up 1.4% to £79.9m This is the most important bit, an agreed partnership with one of the majors could be announced anytime soon and when it does, it’ll light a bonfire under GSK and provide lift off for VEC. Anticipated Major News flow 2018 -2019 Potential generics licensing deal, H2 2018 Open-Inhaled-Close Device As previously announced, Vectura has received feedback from the FDA that its Open-Inhale-Close device could be considered for use in an AB-rated substitutable generic drug-device combination for the GSK Ellipta® portfolio. This is a significant opportunity, with consensus analyst projections of global net sales of the Ellipta® products of approximately $3bn in the US by 2022. Device and formulation development with Vectura’s Open-Inhale-Close dry powder inhaler is continuing, with good progress being made in parallel with ongoing strategic partnering discussions. “we continue to make good progress in our open-inhale-closed program, which we talked about for the first time at the beginning of this year. This product is a potential multiproduct development for an AB-rated substitutable generic program addressing the currently strongly performing GSK Ellipta portfolio. Device and formulation development is progressing well, and there is continued interest in partnering this valuable Suite of potential assets”.

Matal 11 Sep 2018

Interim Accounts .Revenue up 1.4% to £79.9m Okay. So let’s turn to the royalties received from Novartis Ultibro and Seebri, the second-most important driver of the revenue growth on the inhaled side. Novartis continued to see growth for Ultibro, with total end market sales up 11.4 – 11.5%, driven by strong growth in particular in Europe of almost 9% and rest of the world growth of 25%. Ultibro is highly differentiated in the COPD arena and remains the only LAMA/LABA combination with demonstrated superiority versus ICS/LABA in terms of the exacerbations reduction the most serious asthma endpoint prior to mortality, of course. Ex Ultibro U.S. maintains its market leadership, despite now growing less strongly in the fast-growing LABA/LAMA market with multiple entrants, new entrants, most notably from Boehringer Europe. But you can see the impact to the sales for entry tapering off, and the rate of uptake for these new entrants is now slowing. Ultibro reported end market sales were over $500 million in the first – for the first time on an MAT basis and H1 this year. And combined Ultibro Seebri end market sales were close to 700 million growing at almost 10% MAT Q2 '18. Despite the lack of growth in Japan and the absence so far of meaningful revenues from the U.S. to date, we continue to see positive outlook for Ultibro and Seebri overall with combined percentage of revenue continuing to be close to $1 billion. Although it’s not my focus today, it will be remiss of me not to mention the further potential we see from Novartis triple therapy in asthma here in Europe with the program QVM149, with a Phase III European trials progressing well and due to report next year. So I touched on the major growth drivers on our inhaled business, so let me just say a couple of words on our other non-inhaled portfolio. As I said, for the first time, we’re providing more detail on these assets given the relatively broad and total size of these products to our business overall. The like-for-like comparison revenue showed a significant but a negative 17.4 reduction versus H1, as shown by the chart and as expected. The loss of the post patent expiry royalties for ADVATE, in particular, and also – along with a significant reduction in supply chain or reduction of – which benefited from a competitive lack of supply in H1 2017. Combined, these drove a 16.3% reduction in revenue between H1 and H2 last year, but you can see that between H2 and H1 this year, that decline is just 1.3%, which is a much normal decline when you take away those exceptional reductions. Moving now to R&D costs. As I mentioned, the introductory comments we certainly see a significant reduction in the R&D spend from GBP 31.4 million to GBP 25.3 million as a result of really 3 things. Number one, the refocused portfolio prioritization, aligned to our reinvestment strategy we announced in the beginning of the year. We’re also benefiting from the productivity investment initiatives we are implementing, but the third element is the phasing element to our spend, and we do expect further cost in particular for VR647 and 475 to flow through the P&L before the end of the year. And as a result of that, we are maintaining our R&D guidance for the full year of GBP 55 million to GBP 65 million. A key point I would like to make as well to make every asset to manage our total R&D spend. The majority of this investment is, in fact, recouped from our partners, as you can see from the numbers here. So a combination of licensing and milestones and development services essentially means our model allows us to recoup more than 50% of our total R&D costs from partners. This is a basic function of our model. And in fact, for the 12-month period up to the end of June this year, approximately 62% of R&D spend was effectively covered by partner revenues. So now I’d like to summarize our guidance for the rest of the year, which is largely unchanged based on continuing end market performance and visibility of forward orders. The board maintains its revenue growth outlook and expectations. As I said, we should see an acceleration in the growth rate partly driven by relatively weak comparative H2 performance in 2017. We expect higher second half R&D costs and maintain our guidance, as I just mentioned. And CapEx expected to be in the range of GBP 10 million to GBP 50 million as indicated previously. Having summarized the key progress to make from a financial perspective, we’ll focus the rest of the presentation on our pipeline and news flow for the rest of the year. And at this point, I’ll hand over firstly to Roger to start the updates on our overall pipeline progress. Roger? Roger Heerman, Vectura Group plc - EVP of Commercial & Business Development [2] Thank you, James, and good morning, everyone. My name is Roger Heerman. I’m the Executive Vice President of Commercial and Business Development here at Vectura. Over the course of my pharmaceutical industry career, I spent 15 years specifically working in the respiratory area, including the last 8.5 years here at Vectura. My pharmaceutical career started as a sales rep at GSK in the respiratory division selling ADVAIR in the U.S. I guess, you could say being here at Vectura today is bringing me full cycle on the life cycle of that product as generization of inhaled products in the U.S. market approaches. I’d like to start with giving a short overview of Vectura’s portfolio, which is aligned to the refocused reinvestment priorities announced at the start of this year. As you’re aware, in January, we announced our strategic investment priorities away from early-stage novel formulation device and partnering. These types of programs typically carry high molecular risks and extended periods of lower revenue. Today, we are now more focused on outlets with the highest likely value returns and lower molecular risks. You can see in the slide our large inhaled generics portfolio, where we continue to believe we have the wherewithal, capabilities, experience and expertise to be highly successful. This segment is characterized by high barriers to entry. And today, there are a few competitors entering this highly valuable U.S. market with AB-rated programs. Secondly, this portfolio reflects our increased focus in Vectura’s enhanced nebulized therapies. Following the approval of Breelib in Europe and the progress we’ve made with our own nebulized portfolio, we are further extending the leverage of this platform, announcing additional new programs, which Gonzalo will discuss in a few moments. Another area I would like to call your attention to is our potentially AB-rated substitutable generic products, which I will discuss a little bit further in the next couple of slides. As a final point on the pipeline, as you saw yesterday and as James mentioned earlier, the progress we’ve made with flutiform’s breath-actuated k-Haler device, the launch in Europe, initially in the U.K., with further launches anticipated across European countries in the coming months. We believe we are clearly at a tipping point for inhaled respiratory medications in the U.S. And I’m excited to spend the next few minutes reviewing the markets for generics and the progress we are making for with our development portfolio in the generics space. As I said, we remain committed to our belief that the respiratory market will behave like other disease areas. Generics will gain approval offering wider and more affordable access to these important medications for patients. We at Vectura are pleased to be in the leading group of companies developing and progressing these products. As you know, Vectura has already demonstrated the ability to develop and gain approval for generic products with our AirFluSal product in Europe. And as James mentioned in our earlier – in his earlier comments, we’ve also gained approval for our VR632 program of SYMBICORT generic in Europe with our partner Sandoz. So let’s spend a few minutes focusing on the U.S. market today. Reported U.S. sales of respiratory products of approximately $23 billion in 2017 with nearly 65 million inhalers sold in the key DPI and pMDI maintenance classes. However, less than 1% of all sales for generic products – they were less than 1% of all these sales were for generic products. And this is despite the fact that many of the underlying molecules in these products are long past their patent expiration. As you know, one of the key classes currently in focus is the ICS/LABA class. In this area, the 2 main competitors, ADVAIR and SYMBICORT, have seen declines in sales values as they battle for market share and as they have attempted to build a buffer against generic entry. As you can see in this slide, evaluate pharma reported sales of $2.1 billion for ADVAIR and $1.1 billion for SYMBICORT in 2017, which is down from $2.5 billion and $1.2 billion, respectively, in 2016. While we see the declines in value, the underlying volume of the ICS/LABA market remained stable at 35.8 million units. We remain confident in the value of the market based on the margin and volume available for generic products to capture once approved and launched. But our focus is not solely on VR315 or generic ADVAIR. Based on our experience, device and formulation expertise, we, along with partners, are well positioned to progress further generic products in the other current and emerging major classes in the inhaled respiratory space. Here, you can see the potential size of some of the products we believe Vectura is well positioned to progress. As James mentioned, the Ellipta range of products is estimated to be about GBP 3 billion by 2022. – tiotropium for Boehringer is currently at GBP 1.8 billion and the combination LABA/LAMA is expected to be about GBP 0.6 billion by 2024. These products provide significant additional opportunity for our generics business moving forward. So what progress are we making on the current and emerging GX development portfolio? On 315, we have already discussed the large market opportunity that remains despite the price erosion we’ve seen. With our partner Hikma, we are 1 of the 3 sponsors of programs under regulatory review. Recruitment is progressing on a key clinical study, and Hikma plans to submit data to the FDA in 2019, which could allow for potential launch in 2020. In terms of other programs, we announced last year at our Capital Markets Day the licensing of our VR2081, a generic of an existing major inhaled combination therapy for asthma and COPD in the U.S. using a pMDI. The development work on that program is progressing in line with our expectations. Our tiotropium program, VR410, that we licensed from – is progressing with ongoing formulation and development work, and we will conclude our technical feasibility and commercial opportunity to review in the second half of this year and look forward to providing more information on that program once that work is complete. Finally, as we highlighted this year – or earlier this year, our open inhaled close device platform, which we would target as substitutional genetics to the Ellipta range of products is continuing with device and formulation development, and good progress is being made with our strategic partnering discussions. As you can see, the market for inhaled generics means a significant opportunity. Vectura along with its partners is uniquely positioned to be one of the leaders in this area based on our formulation and device capabilities and expertise. And we look forward to continue to share our progress with the market going forward. With that, I would like to turn it over Gonzalo de Miquel, who will speak about our nebulized programs. Roger Heerman, Vectura Group plc - EVP of Commercial & Business Development [3] Thank you, Roger. Good morning, everyone. My name is Gonzalo de Miquel. I’m the Chief Medical Officer at Vectura. And for 20 years, I’ve worked in the respiratory drug development in the pharmaceutical industry in different companies. And I’ve been lucky enough to see some of the asthma drugs has been working on reaching the market and having patients to live better lives. There are many companies today spending hundreds, if not thousands of millions, developing new drugs for asthma and other disease. However, in spite of these huge investments, the asthma, for instance, remains a global health problem, affecting more than 235 million people worldwide. And only in the U.K., every 10 seconds, one person suffers a life-threatening asthma attack. So after so many years working in respiratory, I have come to the conclusion that it may sound a bit provocative, but I’m sure that most of my colleagues, my medical colleagues, would agree with it, which is that, although new therapies, new mechanism of action are needed, they are needed for treating just a few patients, a small group of patients. Because for the vast majority of patients suffering from asthma, the current available therapies aren’t good enough. Actually, many deaths and many life-threatening events could be avoided just by delivering these already available drugs to the right type of action at the – in the right month and also by ensuring a more compliant and more frequent and regular intake of these medications. This is really what I like about Vectura, this unique and very pragmatic approach to this global health problem. As we design and develop devices and formulations, specifically to optimize the drug amount delivered to the right site of action deeper into the lung, deeper into the small airways. So our devices are enabled with the flow and volume control technology that maximizes the dose delivered into the lung, decreasing the amount that is swallowed and then absorbed in the gut and then reaching the blood stream, causing secondary events. This more efficient delivery allows for a reduction in the viability of doses and also allows for a reduction in treatment times. In addition, we enhance our devices with e-technology and connectivity features to allow to improve adherence and compliance through apps and connections to laptops and smartphones. Actually, the effectiveness and the acceptability of our devices have already been proven with the recent approval and successful launch in Europe of Breelib with our handheld nebulizer and also through the results of our recent clinical studies. So as you will see in the next slides, we have a healthy portfolio going forward, based on these unique nebulized technology. So let me start first this portfolio review with our project VR647. VR647 is specifically developed to treat childhood asthma in the U.S., where the unmet medical need as high. As there are very few established approved products for available – for children with asthma, being nebulized the only inhaled steroid, which is approved for children under 4 years. So VR647 is looking to provide an alternative for this treatment to conventional nebulized therapy in children with asthma, offering a similar or better efficacy with a lower total steroid dose, shorter treatment times and a high-tech monitoring system to prove that the right dose has been effectively delivered. And I will come back to that because this is very important. Our market research tell us that in spite of the available generic budesonide in the U.S. market, VR647 profile supports a premium price over generics and price parity with – so it represents – 647 represents a significant marketable opportunity as the use of nebulized budesonide is widespread and stable. So as you might be aware, we recently reported on the results of our Phase II clinical trials for 647. We reported the methodology study with a mouthpiece and pharmacokinetic studies. Prior to that, a solid proof-of-concept study running 20 pediatric patients strongly suggested superior efficacy of our devices at a quarter of the conventional dose of budesonide versus standard nebulizer, giving us a very strong confidence to move forward. So what have been the results of the most recent Phase II trials? So let’s go first to the methodology or usability study. Traditionally, it was thought that – believed that young children below 4 years couldn’t use a mouthpiece effectively, particularly if it was connected with a breath-activated device. And we challenged that assumption. So we took 40 kids, 40 children aged 1 to 4 inclusive, and tested them with a mouthpiece to inhale a fixed volume of aerosol with our device 647. Our study demonstrates that more than 90% of children aged 2 and above could perfectly – were perfectly able to use the device with a mouthpiece, and most were able to do so already at the first attempt. It was a very intuitive maneuver and actually majority required more aid from parents or caregivers. So this was a very successful result for the program progression because it allowed us to determine the lowest age range in our Phase III program and also in our future label. So – but also because the mouthpiece is a much better, much more efficient system to deliver drugs into the lung than any other, like the facemasks. So in addition, we got a very positive feedback on one of the main concerns of parents and carers regarding the use of conventional nebulizers in young children, namely, if the kid has effectively taken the drug and how much has the kid will have taken. And because with conventional nebulizers, there is no way to know if the kid has taken the drug or the drug has been sprayed out into the lung area. So our unique nebulizers actually provide a real-time information on the dose delivered and on the remaining inhalations left to complete treatment. This is – this reassuring feedback was very highly appreciated by the health care providers, health care professionals involved in the study as well as the parents. So in the pharmacokinetic study, we showed that with the fraction of the dose, our technology can achieve similar exposure in the lung as a conventional nebulizer. This is vital because we want to prevent unnecessary exposures to steroids to kids and avoid adverse events. Additionally, because we need to deliver less drug with our technology, treatment times were reduced from the in-clinic delivery time of 6 to 7 minutes with the conventional nebulizer to 1 minutes to 2 minutes with our device. In the study, the nurse monitored very closely the delivery times and stopped the conventional nebulizer as soon as certain volume had been reached or certain remaining volume had been reached. However, at home, normally, the conventional nebulizers take between 10 and 15 minutes to complete. So if any of you have children, you will understand how difficult it is to make kids comply with treatments that require them staying still for 10 minutes or more twice a day every day over a long period of time. So you will appreciate the importance of this progress. So these results give us information we need to move to a Phase III study. But prior to that, we plan to meet with the FDA and discuss with them the Phase III program as quickly as possible. Rest assured that these results will be fully published in a peer-reviewed journal as soon as we can. And also, we will communicate them in the relevant scientific fora. So now let me move on – sorry – let me move on to our next wholly owned project, VR475. So while 647 aimed to deliver lesser drug – less drug with the same or better efficacy than the conventional nebulizer, VR475 aims to use our existing technology to deliver the same amount of drug but achieve better outcomes. So better efficacy outcomes, but with no impact on safety. In fact, the study we are conducting, which is ongoing, is designed to confirm that 475 reduces the frequency of exacerbations and improve the asthma control and the lung functions in adults and adults with severe asthma. And these are patients are – asthmatic patients that are uncontrolled despite the use of high doses of inhaled steroid and a second control medication. So doing so, VR475 will become an additional alternative step in the treatment of asthma of this patient before the expensive – before having to resort to expensive biologics or unsafe oral steroids. This program is focused in Europe, and the Phase III clinical trial is progressing well. We expect to see headline results by the end of this year. Partnering activities will progress once we have the clinical data results. So I have updated you on the progress we are making in 2 of our key budesonide programs, and we believe that opportunities do not stop here. To be on the proven device formulation development capabilities that Vectura is well known for, I’m very pleased to be able to talk today for the first time about the progress of our R&D strategy. We call this progress the VENT strategy, which stands for Vectura enhanced nebulized therapy strategy. Like with budesonide, we can use our proprietary technology even further, taking other existing drugs, approved drugs either for respiratory conditions or non-respiratory conditions, and repurpose them and reformulate them to improve and optimize their efficacy and safety profile, providing you more effective treatment for airways diseases with high unmet needs. So actually, there are many conditions in – with high unmet needs in the respiratory field. And there are great opportunities to improve this already existing therapies by delivering them better into the right site of action with our formulation and nebulization capabilities. So after further assessments, we have prioritized a number of conditions, amongst which we have the inhaled management of difficult-to-treat cardiopulmonary disease that, although rare, it can be life-threatening, and there are few available treatment options. We have also found inhaled treatment for the underlying inflammation in cystic fibrosis, for which there is no available anti-inflammatory today. And also for the prevention and treatment of pulmonary infections in transplanted immunocompromised patients, which are very susceptible to all kinds of infections. And here, there is a lot of opportunities as well. So these are 2 enhanced nebulized strategy are for us are like – very high likelihood of success because the drugs we are targeting are already proven to be safe and effective. This makes the development times shorter and also shorter time to realize the value. These untapped respiratory niche market represents a multibillion opportunity today, and each of these niche opportunities could easily deliver peak sales of above GBP 250 million each. So we’ve made headroom in our R&D budget, and we have already initiated development of some lead candidates. And I’m really excited by this really fine strategy. I hope in the next interactions we will be in a better position to give you more details of these assets on the progress of them. And with this, I would like to conclude my pipeline review and hand over to James Ward-Lilley. James Ward-Lilley, Vectura Group plc - CEO & Executive Director [4] Thank you, Gonzalo. Thank you, Roger. We’ll come back to these 2 gentlemen during the Q&A segment. Before I close, I’d like to quickly recap on the key messages I see from today’s presentation. First and foremost, we clearly see the business is regaining momentum, and that’s a positive outlook after what was a challenging '17. We see growth in H1 underpinned by the continued inhaled market performance. And importantly, a good step up in flutiform revenues to Vectura in particular and alignment normalization with market performance of flutiform. We’re also seeing, as Gonzalo and Roger have shown, a good progression in our refocus pipeline with the approval and continued development of key milestone catalysts for our generic portfolio and our focus in our unique nebulized platform is being increasingly validated. And we see particularly exciting prospects with a new series of enhanced assets that Gonzalo has just described. This really is doing what Vectura what does the best, leveraging its unique formulation device assets with the potential to significantly improve therapy for patients as well as providing potential for very meaningful returns to shareholders. We continue to demonstrate our focus on operational excellence, stepping up productivity, improving margins and creating capacity to do more of the same or to lower costs. And with revenue growth of cash-generative assets alongside operational excellence and tight financial management and capital allocation discipline, we continue and are able to build on our strong existing balance sheet. Vectura’s positive momentum is set to continue in H2. We look forward to a series of additional catalysts as we close the year and head into 2019. As mentioned, we continue to make good progress in our partnering discussions to the open-inhale-closed program device. And following the positive 647 results, our minds are now clearly focused on the VR475 Phase III results, which, as Gonzalo said, we expect to see the headline results for before the end of the year. As I said several times before and as mentioned by Gonzalo, we set a high bar as the endpoint for that Phase III study. But if successful, we believe this product device combination could make a very meaningful difference to the lives of severe asthmatic patients and that’s real alternative ahead of the fast-growing and very expensive biologics segment.