BTG trading in line as shareholders muster for AGM

The FTSE 250 firm said that in oncology, ‘TheraSphere’ revenues grew in all geographies, with another record number of patients treated in the three months to June.

TheraSphere was now sold direct in Turkey, where BTG recently established a sales operation.

Additionally, its cryoablation unit had made a “very strong” start to year, particularly in the European Union with the transition to direct sales in Germany, Spain and the UK.

BTG said the EPOCH Phase III study was now more than 85% enrolled, and was on track to report top-line data in 2019.

“EPOCH is designed to support a premarket approval (PMA) for TheraSphere in the US as a second-line treatment for patients with metastatic colorectal cancer,” BTG’s board explained.

“Success would expand use of TheraSphere into a new patient population of around 60,000 patients per year across the US and five largest EU countries combined.”

The STOP-HCC study of TheraSphere in patients with hepatocellular carcinoma was now fully enrolled, the company added.

It was also designed to support a PMA application in the US, and was on track to report top-line data in 2019.

Success there would enhance the continued expansion of TheraSphere as a treatment for patients with hepatocellular carcinoma.

The board said the SOLSTICE cryoablation study demonstrated local tumour control in 88% of patients with lung metastases, while maintaining quality of life.

In the MOTION cryoablation study, 61% of patients with bone metastases experienced a “clinically meaningful” reduction in pain and an improved quality of life, it added.

“These studies support the continued expansion of cryoablation into a range of cancers beyond kidney cancer and both are being prepared for formal publication.

“Immuno-oncology is transforming cancer treatment and there is intense research into combination treatments to improve efficacy.

“BTG is excited about the potential to enhance the efficacy of immuno-oncology drugs by combining them with the company's interventional oncology treatments.”

Nine grants had now been awarded in a programme with the Society of Interventional Oncology to explore that combination approach in a range of cancers.

BTG said “promising” first data from the programme was presented at the World Congress of Interventional Oncology in June, which it added demonstrated that local embolisation promoted a robust immune response in tumours that had few immune cells prior to treatment.

The company was also supporting a number of investigator-initiated studies at “leading” US academic hospitals, exploring the combination of the company's interventional oncology products with marketed immuno-oncology drugs.

In addition, it was working towards the initiation of company-sponsored clinical studies.

On the product innovation front, BTG said its investment in research and development was continuing to deliver new products, including an expanded range of embolising beads such as the visible ‘LUMI’ bead, and advanced dosimetry software for TheraSphere.

New needles were being added to the cryoablation systems, with one being a flexible needle for delivery down a bronchoscope to enhance access to lung tumours.

BTG said new systems being introduced included a portable CT cryoablation system, and a system that added tumour visualisation to the ablation procedure.

A new ablation modality targeting liver tumours was also under development.

In vascular, the board said a good performance in the first quarter of the 2019 financial year reflected the continued growth of ‘EKOS’ as a treatment for pulmonary embolism (PE) in the US.

European expansion was continuing, and a direct sales team had been established in Germany.

‘KNOCOUT PE’ was said to be progressing well, with the international registry study designed to provide real world clinical and utilisation data to support further growth in EKOS in PE across many geographies.

Sales of the ‘CentreCross’, ‘MicroCross’ and ‘MultiCross’ devices acquired from Roxwood were continuing to build following their transition to BTG's vascular sales force in early 2018, with June the strongest sales month to date.

Looking at its other interventional medicine, BTG said orders and reorders of ‘Varithena’ had continued to build month-on-month following the introduction of new CPT reimbursement codes in the US in January 2018.

The board said it was continuing to monitor the impact of the new codes on physician adoption and on insurer coverage and payment practice, which should be clear by the end of 2018.

As it announced in June, an Advisory Committee Panel of the US Food & Drug Administration (FDA) voted against recommending the approval of ‘Elevair’ - known as the ‘PneumRx Coils’ in the EU - for the treatment of people with severe emphysema.

BTG anticipated that the FDA would conclude its review of the PMA application for Elevair late in the summer.

On the pharmaceuticals front, the firm said its product portfolio had made a “very good” start to the year, benefitting from ‘CroFab’ orders at the start of the new bite season.

The timing of ‘DigiFab’ expiry orders, and the continued worldwide growth of ‘Voraxaze’, had also had a positive impact on sales.

“BTG remains confident that CroFab is well-placed to maintain its leadership position following the potential introduction of another antivenin after October,” the board said.

It noted that CroFab had a broad label, with a strong track record of efficacy and safety in more than 50,000 patients treated to date.

“Following a strong financial performance last year in which we grew revenues 10% and underlying profits 20%, I am pleased to report that trading since 1 April is in line with expectations and the board reiterates its guidance for the full year,” said BTG CEO Louise Makin.

“We are now well on our way in transforming BTG into a product sales business with diverse and sustainable revenue streams and I am particularly pleased about the progress we are making in implementing our Interventional Medicine leadership strategy.

“There is real momentum across our portfolio and each of the core pillars of interventional oncology, interventional vascular and pharmaceuticals continues to perform well.”

Makin said the company's product sales business was well placed to deliver growth organically.

“We remain ambitious to use our significant financial resources to augment this with acquisitions to deliver on our vision of being a world leader in interventional medicine, transforming patient care and creating significant long-term value for shareholders.”