21 March 2018

- Performance in-line with expectations, with strong in-market growth from key inhaled products -

 

Chippenham, UK - 21 March 2018: Vectura Group plc (LSE: VEC) ("Vectura", "the Group", "the Company"), an industry-leading inhaled product formulation, device design and development business, today announces its preliminary results for the year ended 31 December 2017. 

Financial highlights

  • Full year reported revenue of £148.0 million, in line with Board expectations (reported 9m 2016: £126.5 million)
    • 2016 full-year proforma[1],[2] revenue was £183.6 million. 2017 reported revenue was lower due to reduced revenues from non-recurring sources[3] of £16.6 million in 2017 compared to £57.3 million in the 2016 proforma
    • 2017 underlying2,[4] revenue was £131.4 million; +4.0% driven by the Group’s key-inhaled products
    • 2017 underlying revenue from flutiform®, Ultibro® and Seebri® Breezhaler® +5.4% to  £85.8 million
      • Strong annual in-market net sales growth from key products: flutiform® +11.8% (CER) and Ultibro® Breezhaler® +20.6% (CER) [5],[6]
      • Group reported revenue growth was moderated compared to in-market sales growth by previously-reported destocking in flutiform® and Ultibro® Breezhaler® supply chains, which had no impact on in-market sales momentum
  • IFRS-reported operating loss of £96.2 million, due to the impact of a full year, non-cash charge for amortisation and impairment of intangible assets of £109.7 million, arising from prior acquisitions (9m 2016: £44.5 million operating loss and £64.0 million amortisation charge)
    • Adjusted EBITDA2,[7] was ahead of expectations at £25.8 million profit (reported 9m 2016: £34.1 million profit), driven by in-line revenue performance, delivery of merger synergy savings and tight R&D cost management. R&D costs of £60.3 million were at the lower end of the guidance range (reported 9m 2016: £45.6 million)
    • The reduction in adjusted EBITDA versus reported 9m 2016 reflects a full year of R&D costs in 2017
  • Ongoing disciplined capital allocation and working capital management delivered strong operating cash inflows and the Group ended the year with a closing cash balance of £103.7 million (31 December 2016: £92.5 million)


Operational highlights

Refocused pipeline investment with progression of key priority programmes

  • Inhaled generics
    • Two major new generics programmes added to the pipeline (VR2081 and VR410), with the potential for development of additional combination therapy (LAMA/LABA)
    • Following FDA interactions, Vectura is progressing the development of its Open-Inhale-Close device which has the potential to be an AB-rated substitutable generic drug-device combination for the GSK Ellipta® portfolio. This is a significant opportunity, with analyst projections of global net sales of the Ellipta® products of approximately $6 billion by 2023[8]. Pharmaceutical development has commenced, in parallel with partnering discussions
    • Post period update – Following the FDA rejection of CRL dispute resolution process, Hikma confirmed the enrolment of the first patients in a repeat clinical programme for VR315 (US) will take place in the coming weeks.  Potential approval and launch during 2020
  • Vectura enhanced therapies utilising our proprietary smart nebulisation technology
    • Lead programmes, VR475 (EU) Phase III and VR647 (US) Phase II, progressing well with potential extension of portfolio under assessment following technology validation from BreelibTM EU approval and launch

Tight financial management with R&D and capital allocation discipline

  • Merger integration completed and on track to deliver £11 million to £12 million annual cost synergies from 2018. Majority of these annual synergy savings realised in 2017
  • Effective prioritisation of R&D portfolio and Operational Excellence review to deliver productivity gains and reduced pipeline risk whilst maintaining significant value potential
  • Post period update – £15 million share buyback completed on 28 February 2018

Outlook

With continuing strong in-market product performance, together with delivery of synergy savings and Operational Excellence benefits, the Board maintains its 2018 revenue growth expectations and reiterates its previously-reduced R&D investment guidance range of £55 million to £65 million for the year. 

 

[1] The 2016 reported comparative results cover a shortened nine-month period and reflect the enlarged merged business for almost seven months. Therefore, in order to support a clear and effective assessment of the Group’s performance in 2017, the Directors have provided additional unaudited proforma full-year financial information for 2016. A reconciliation of 2016 reported results to 2016 unaudited proforma full-year financial information is provided in the Financial Review

[2] This press release includes certain non-IFRS measures, including full-year comparative financial information, underlying financial information and adjusted EBITDA. Reconciliation of these measures to their most directly comparable IFRS measures is provided in the Financial Review

[3] Non-recurring sources of revenue comprises milestones, development services and non-recurring royalties from ADVATE® and GSK Ellipta® products. Refer to the Financial Review for further information 

[4] Underlying revenues exclude the impact of licensing milestones and development services revenues, which can vary materially from period to period, and also exclude material royalties that are not recurring as a result of patent expiry or legal dispute.  A reconciliation of reported and proforma full-year financial information to underlying financial information is provided in the Financial Review   

[5] In-market net sales are internal calculations using IQVIA Health (IMS) data based on sales to pharmacies and excluding certain minor countries which are not covered by IQVIA. In-market net sales are not the same as sales to wholesalers on which royalties are payable to the Group. All percentages quoted at constant currency rates

[6] Constant currency (CER) removes the effects of currency movements from the percentage growth rate quoted. Constant currency figures are taken either from partner announcements or from IQVIA data and are not calculated by the Company

[7] Adjusted EBITDA is defined as operating loss adding back amortisation and impairment, depreciation, share-based payments and exceptional items

[8] Global Data, extracted Q4 2017

“It has been an important year of progress for Vectura. We have delivered a good set of financial results, in line with market expectations, and our key partnered inhaled products, flutiform® and Ultibro® Breezhaler®, have continued to show strong in-market growth. Notwithstanding the disappointing delays we have seen for our VR315 (US) generic Advair® programme, we continue to see substantial value in the development of complex inhaled generics. In light of this, we have extended our valuable inhaled generics portfolio. In addition, we have also progressed our enhanced therapy pipeline and fully delivered our merger integration plans. Our refocused investment strategy, announced in January 2018, is underpinned by a strong core business, tight financial discipline and a skilled workforce. We are committed to fully leveraging the capabilities and technologies that differentiate us to maximise the value of our pipeline at a substantially lower cost and relative risk. We have clearly defined priorities and we look forward to a series of significant news flow catalysts during 2018.”

James Ward-Lilley

Chief Executive Officer of Vectura

Analyst briefing

James Ward-Lilley, Chief Executive Officer, and Andrew Derodra, Chief Financial Officer, will present the Preliminary Results for analysts today at 9.30am to 10.30am GMT. 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:

 

Participant local dial-in: 

+44 (0)330 336 9105

Participant free phone dial-in: 

0800 358 6377

Participant code:

7882963 

 

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

 

- Ends -

 

Enquiries

 

Vectura Group plc

+44 (0)1249 667 700

Andrew Derodra – Chief Financial Officer

David Ginivan – Vice President Communications

Elizabeth Knowles – Director Investor Relations and Analysis

Julia Wilson– Director Investor Relations

 

 

 

 

 

Consilium Strategic Communications

+44 (0)20 3709 5700

Mary-Jane Elliott / Philippa Gardner / Jessica Hodgson

 vectura@consilium-comms.com

       

 

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.

 

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