flutiform®

flutiform® continues to perform well in competitive markets, supported by recent lifecycle progress

£79.6m
Revenue

43.3%
Gross profit margin

We expect that the launch of the breath-activated flutiform® k-haler® and the addition of the positive opinion for the paediatric indication of flutiform® in Europe will reinforce the continued differentiation of the product.

flutiform® (Mundipharma, Europe and Rest of world (excl. North America) / Kyorin, Japan)

flutiform® generated total in-market sales of €221.7m, up 8.5% in value (CER) and up 12.2% in volume1, contributing £79.6m revenue for Vectura, up 13.7% compared to 2017.

The European ICS/LABA market is a highly competitive and genericised market which declined by 3.3%1 in value during 2018. Despite the slowing of in-market sales growth rates, flutiform® sales in Europe grew 2.0%, to €114.4m, and grew 2.7% in volume, reaching a market value share of 3.8% of the ICS/LABA market1. We expect that the launch of the breath-activated flutiform® k-haler® and the addition of the positive opinion for the paediatric indication of flutiform® will reinforce the continued differentiation of the product in this challenging market.

The less mature and non-genericised Japanese market grew by 3.3%1 in value. In-market sales of flutiform® grew strongly, up 12.8% value and 17.4% in volume, to €87.2m1, despite price reductions of approximately 5.8% in place since April 2018. flutiform® reached a market share of 15.4% in volume and 12.2% in value, up 1.2pp and 0.7pp respectively compared to 2017 1.

flutiform® remains at an early stage of its lifecycle in rest of world territories and has continued to grow strongly, with in-market sales of €20.1m up 35.1% compared to 2017 1.

flutiform® sales by region(€m MAT)1

1 IQVIA SMART MIDAS constant currency sales. Royalties payable by partners to the Group are based on agreed contractual definitions of net sales, which differ from IQVIA reported sales, and may include other adjustments or deductions.

Ultibro® Breezhaler®

Ultibro® Breezhaler® maintaining ex-US LAMA/LABA class leadership

£13.7m
Revenue

100%
Gross profit margin

Ultibro® Breezhaler® continues its class-leadership of the dual bronchodilator class (ex. US), with growth of 7.9% compared to 2017, despite increased competition.

Ultibro® Breezhaler® and Utibron™ Neohaler® Inhalation Powder (Novartis/Sunovion, US)

Ultibro® Breezhaler® continues its class-leadership of the dual bronchodilator LAMA/LABA class (ex. US), with growth of 7.9% compared to 20171, despite increased competition. In-market sales in Europe grew by 6.3%, to $385.4m and also grew strongly in rest of world, up 23.2% to $73.4m1. Vectura recognised royalties of £17.8m in respect of sales of Ultibro® Breezhaler® and Seebri® Breezhaler® (2017: £17.3m).

Japanese in-market growth remains low at 0.4% with in-market sales of $45.8m, and limited sales in the US of $7.4m1 reflecting the challenge for the fourth market entrant in a competitive market and market access restrictions.

Novartis expects the QVM149 Phase III study completion in H2 2019 with regulatory submission in Europe and Japan also in H2 2019, triggering a filing milestone to Vectura of $2.5m. The Group will earn royalties on net sales upon launch of the product. The product has the potential to be one of the first LAMA/LABA/ICS therapies for asthma. Current consensus estimates sales of $238m by 2024.2

Ultibro® sales by region (US$m MAT)1

1 IQVIA SMART MIDAS constant currency sales. Royalties payable to the Group by partners are based on agreed contractual definitions of net sales, which differ from IQVIA reported sales and may include other adjustments or deductions.

2 Evaluate Pharma Consensus Worldwide Peak Sales extracted March 2019.

OUR IN-MARKET PRODUCTS

Novel IP Licensing

Seebri® Breezhaler®

(EU and RoW – launched 2012)

Seebri™ Neohaler®

(US – launched late 2017)

COPD
Easy to use DPI device and effective bronchodilator (LAMA).
Generic partnering

AirFluSal® Forspiro®

(EU and RoW, ex. US – launched 2014)

Asthma/COPD
Anti-inflammatory and bronchodilator (ICS/LABA) delivered using Vectura’s proprietary GyroHaler® DPI device is a cost-effective alternative to Seretide® and/or other ICS/LABA treatments.
Vectura enhanced therapies

BreelibTM

(EU and ROW, ex. US – launched in 2017)

Pulmonary arterial hypertension
Vectura’s proprietary handheld FOX® nebuliser used to deliver Bayer’s iloprost solution – delivery technology reduces mean inhalation time per treatment vs other smart nebuliser (10.9 minvs 2.6 min) meaning that a typical patient’s inhalation time per day is reduced by 76%.
Novel IP Licensing

Relvar® Ellipta®/Breo® Ellipta®

(Global)
Launched 2013 (US and RoW)
Launched 2014 (EU)

Asthma/COPD
Once-daily anti-inflammatory and bronchodilator (ICS/LABA) which utilises Vectura’s formulation IP.
Novel IP Licensing

Incruse® Ellipta®

(Global)
Launched 2014 (RoW)
Launched 2015 (US and EU)

COPD
Once-daily bronchodilator (LAMA) which utilises Vectura’s formulation IP.
Novel IP Licensing

Anoro® Ellipta®

(Global)
Launched 2014 (US, EU and RoW)

COPD
Once-daily dual bronchodilator (LAMA/LABA) which utilises Vectura’s formulation IP.
Novel IP Licensing

Trelegy® Ellipta®

(Global)
Launched 2017 (US and EU)

COPD
Once-daily triple therapy (ICS/LABA/LAMA) which utilises Vectura’s formulation IP.
Novel IP Licensing

Seebri® Breezhaler®

(EU and RoW – launched 2012)

Seebri™ Neohaler®

(US – launched late 2017)

COPD
Easy to use DPI device and effective bronchodilator (LAMA).
Generic partnering

AirFluSal® Forspiro®

(EU and RoW, ex. US – launched 2014)

Asthma/COPD
Anti-inflammatory and bronchodilator (ICS/LABA) delivered using Vectura’s proprietary GyroHaler® DPI device is a cost-effective alternative to Seretide® and/or other ICS/LABA treatments.
Vectura enhanced therapies

BreelibTM

(EU and ROW, ex. US – launched in 2017)

Pulmonary arterial hypertension
Vectura’s proprietary handheld FOX® nebuliser used to deliver Bayer’s iloprost solution – delivery technology reduces mean inhalation time per treatment vs other smart nebuliser (10.9 minvs 2.6 min) meaning that a typical patient’s inhalation time per day is reduced by 76%.
Novel IP Licensing
Novel IP Licensing

Relvar® Ellipta®/Breo® Ellipta®

(Global)
Launched 2013 (US and RoW)
Launched 2014 (EU)

Asthma/COPD
Once-daily anti-inflammatory and bronchodilator (ICS/LABA) which utilises Vectura’s formulation IP.
Novel IP Licensing

Incruse® Ellipta®

(Global)
Launched 2014 (RoW)
Launched 2015 (US and EU)

COPD
Once-daily bronchodilator (LAMA) which utilises Vectura’s formulation IP.
Novel IP Licensing

Anoro® Ellipta®

(Global)
Launched 2014 (US, EU and RoW)

COPD
Once-daily dual bronchodilator (LAMA/LABA) which utilises Vectura’s formulation IP.
Novel IP Licensing

Trelegy® Ellipta®

(Global)
Launched 2017 (US and EU)

COPD
Once-daily triple therapy (ICS/LABA/LAMA) which utilises Vectura’s formulation IP.
Royalties earned on sales of the Ellipta® products are capped at £9m p.a.