Pre-close trading update confirms good progress

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 10^th  January.

- Ends-

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Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

About Vectura

Vectura is an industry-leading inhaled product formulation, device design and development business offering a uniquely integrated inhaled drug delivery platform. We develop inhalation products to help patients suffering from airways diseases.

Vectura has eight key inhaled, two non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Bayer, Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork.

Vectura's strategy is to fully leverage its differentiated technology and skills, maximising value by enhancing the delivery and performance of inhaled products and through the development of high-quality generic alternatives to branded therapies.

For further information, please visit Vectura's website at www.vectura.com.