Vectura Group plc: Interim Results For The Six Months Ended 30 June 2018

Vectura regaining momentum with continued inhaled revenue and adjusted EBITDA growth
Chippenham, UK - 11 September 2018 -- Vectura Group plc (LSE: VEC) (“Vectura” or “the Group”) announces its unaudited Interim Results for the six months ended 30 June 2018 and reiterates its current guidance for the full year.

Financial & Operational Highlights

Financial

• Total reported revenue for the period of £79.9m up 1.4% (+2.1% constant exchange rates (CER))

o Inhaled portfolio revenue up 7.1%. Following H2 2017 de-stocking, flutiform® revenues to Vectura are normalising with revenue up 3.1% vs H1 and 6.1% vs H2 2017.

o As expected, other (non-inhaled) portfolio revenues were down 17.4% due to non-recurrence of 2017 post patent royalties and lower product supply revenues.

• Guidance for R&D costs of £55-65m for 2018 remains unchanged reflecting the Group’s refocussed portfolio prioritisation and initiatives to transform R&D productivity. R&D costs of £25.3m were 19.4% lower than H1 2017. The group anticipates a step up in phasing of R&D costs in H2 2018, principally related to VR475 and VR647.
• Operating loss has reduced by £11.1m, mainly driven by a decrease of £8.1m of amortisation and lower R&D costs partially offset by exceptional items.
• Adjusted EBITDA² of £24.6m is up 51.9% vs H1 2017 benefiting from productivity initiatives, including good progress in procurement and supply chain, and R&D phasing, with operating margin before amortisation and exceptional items at 25.9%, vs 15.7% H1 2017.
• Cash balance of £83.9m (December 2017: £103.7m) reflecting completion of share buyback programme, capital investment and annual cash flow phasing.

• Vectura Enhanced Nebulised Technology

o Phase II pharmacokinetic and mouthpiece usability studies for VR647 support the progression of a Phase III programme. VR475 Phase III programme on track with headline results expected in Q4 2018.

o Progressing a series of new pipeline projects with significant potential future value.

• Inhaled Generics

o VR315: recruitment is progressing on a repeat clinical study, Hikma anticipates being able to submit data to FDA in 2019, potential launch in 2020.

o VR632 was approved in Europe, with launches planned in 2019.

o Device and formulation development with Open-Inhale-Close dry powder inhaler is continuing, with good progress being made in strategic partnering discussions.

Commenting on the interim results, James Ward-Lilley, Chief Executive Officer of Vectura, said:

“Vectura is regaining momentum after a challenging 2017. Inhaled in-market growth is continuing with flutiform® stock levels normalising resulting in total inhaled Vectura revenues increasing 7.1% vs H1 2017. Our refocussed pipeline is making progress with Phase II VR647 results a key highlight in H1 2018. We have identified and are progressing a series of new pipeline projects, and we look forward to the read-out of the VR475 Phase III adult asthma study later this year. With positive in-market momentum and additional pipeline catalysts, we look forward to delivering against our strategy in the second half of 2018 and we maintain our full-year guidance.”

Analyst briefing

James Ward-Lilley, Chief Executive Officer, will present the Interim Results for analysts today at 9.30am BST. The presentation will be held at the offices of Numis Securities Ltd., 10 Paternoster Square, London, EC4M 7LT. There will be a simultaneous live conference call.

Dial-in details are:

A live webcast of the meeting and the presentation slides, will be available on Vectura’s website: https://www.vectura.com/investors/presentations-and-webcasts

- 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.

¹ In order to simplify how we present our portfolio of assets and ensure consistency with how we assess the performance of the Group internally, we have aggregated the performance of our inhaled assets, reported previously as eight products marketed by partners and other inhaled assets as “inhaled”. The eight products are flutiform®, Seebri® Breezhaler®, Ultibro® Breezhaler®, AirFluSal® Forspiro®, three GSK Ellipta® products and Breelib^TM. The remaining assets were previously described as legacy “oral” and “non-inhaled” and are simply shown as “Other (non-inhaled)”.

² Adjusted EBITDA is a non-GAAP measure which is calculated as operating loss, adding back amortisation and impairment, depreciation, share based payments and exceptional items.

³Adjusted EBITDA was reported as £18.9m in H1 2017 as it included the £2.7m one off R&D accrual release, which was separately disclosed. In order to present adjusted EBITDA on a consistent basis with the Annual Report and Accounts 2017, management has excluded the one off R&D accrual release from adjusted EBITDA as an exceptional item