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London, UK, 06 October 2015
BTG plc (LSE: BTG), the specialist healthcare company, announces the following update for the six months to 30 September 2015 ahead of the publication of its Interim Results on 10 November 2015.
We are making good progress in implementing our growth strategy to become a leader in Interventional Medicine. Strong first half performances from the Interventional Oncology and EKOS products have been supplemented by a full six months of revenues from PneumRx. Physician interest in Varithena® (polidocanol injectable foam) remains strong and insurance coverage is expanding, but this has not yet translated into sales growth. Specialty Pharmaceuticals revenue is similar to that in H1 14/15, while Licensing revenues are higher. We currently anticipate that full year Group revenue will be in the lower half of our guidance range of £410m to £440m (at an exchange rate of £1:$1.61).
Louise Makin, BTG’s CEO, commented: “There is good momentum across the business and we expect to deliver double-digit revenue growth over the full year. We anticipate continued strong commercial execution from Interventional Oncology and EKOS. We are focused on accelerating market adoption of Varithena® by continuing to expand reimbursement coverage, and we remain confident of its long-term potential. We will continue to seek to secure wider European reimbursement for the PneumRx Coils and look forward to data from the RENEW study in the US around the end of 2015. Overall, we are successfully implementing our growth strategy, using the strong financial underpin from Specialty Pharmaceuticals and Licensing to invest in commercial expansion, innovation and development activities to generate further enhanced growth.”
Interventional Vascular: Varithena®
We continue to receive very positive feedback on the clinical profile and patient acceptability of this varicose veins treatment from US physicians. At the end of September 2015, 524 physicians (468 in mid-July 2015) had enrolled for training with 248 (223 in mid-July 2015) having treated patients or scheduling patients for treatment. We are also making good progress as we seek to establish widespread insurance coverage and appropriate payment levels for the product and procedure. Approximately 139 million US lives (130 million in mid-July 2015) of ~320 million total US insured lives are now covered by payers who have given favourable policy coverage for Varithena®, with ~72 million lives (56 million in mid-July 2015) covered by payers who have also paid claims at appropriate rates for both product and procedure.
As noted previously, Varithena® claims currently take significantly longer to settle than claims for established treatment options, and longer than our previous guidance had anticipated. As a result, the majority of physicians are not yet regularly reordering after completing their initial patient evaluations. Based on our current expectations of the timing of gaining coverage from key insurers, and of how long that is likely to take to result in increased physician reordering, we now believe that full year revenue is likely to be around the same level as in the prior year.
We expect continued progress in achieving positive policy determinations, adequate payment levels and reduced claim settlement times from payers as we move through the second year of the two-year controlled launch programme. Together with the ongoing physician interest and positive clinical experience, we continue to anticipate that there will be an inflection point leading to strong sales growth during our 2016/17 financial year and we remain confident that Varithena® can reach $250m annual sales by 2021 in the US reimbursed and self-pay sectors.
In addition, Varithena® has the potential to achieve a further $250m per annum in revenue by 2021 from a combination of geographic expansion and new indications. Regulatory approval was granted in Canada during the period and we anticipate the commercial launch in the first half of 2016. We are continuing development of related products to treat other venous disorders, with potential approvals from 2017.
Interventional Vascular: EkoSonic® Endovascular System
A growing base of US hospitals using the EkoSonic® interventional treatment for blood clots, and the specific clearance for use in the US to treat pulmonary embolism, have contributed to strong revenue growth. We have begun recruiting patients into our next pulmonary embolism study OPTALYSE, as we look to provide further clinical evidence of the role of EkoSonic® in treating this condition. We expect growth of over 20% for the full year.
A strong first half in the Interventional Oncology franchise reflects the continued growth in the US of TheraSphere® and the initial positive impact of expanding its EU sales force, together with a steady overall performance from the Bead products. We anticipate further progress, with TheraSphere® continuing to make further inroads in the US and European markets and Beads growing steadily in the US and Europe, where the full impact of selling direct is expected to be realised in future years. We have hired our first sales representatives in Canada who are initially detailing TheraSphere®. In Asia, our partner SciClone Pharmaceuticals has won its first provincial tender in China for DC Bead®, and in Japan our partner Eisai has received expanded approval for DC Bead® to treat hypervascular tumours and arteriovenous malformations; TheraSphere® has been approved in Singapore and South Korea. Interventional Oncology is on track to deliver around mid-teens revenue growth over the full year.
In May 2015 we reported top-line data from the French-government-sponsored REVOLENS study, showing that at six months post-treatment the PneumRx Endobronchial Coil System was superior to the standard of care for improving exercise capacity in patients with severe emphysema. Data from this study will be used to support an application for full reimbursement in France, which is anticipated by the end of 2016. Sales are currently concentrated in a small number of markets and securing wider and full reimbursement coverage in key European markets is the main focus of our commercial activities.
Patient follow-up continues in the RENEW study in the US, with top-line data anticipated around the end of 2015. We expect to submit a PMA application in H1 2016 that could lead to US approval around the end of 2016 as priority review has been granted.
The Interventional Pulmonology market is at an early stage in its development. We do not currently provide annual sales guidance but PneumRx has strong growth potential and we are targeting sales of $250m by 2021.
Seasonal weather patterns in the US have led to slightly reduced wholesaler orders for the snakebite treatment CroFab® than in H1 14/15. We have also seen somewhat lower orders for the digoxin overdose treatment DigiFab® compared with the prior period, which benefitted from cyclical replacement of expired stock by US hospitals. Following two years of 20%+ growth, we anticipate more typical single-digit revenue growth this financial year.
Our partner Wellstat Therapeutics’ new drug application (NDA) for uridine triacetate has been accepted for review by the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act action date in March 2016. The NDA seeks approval of uridine triacetate as a treatment for patients at risk of serious toxicity following an overdose of the chemotherapy agent 5-fluorouracil (5-FU).
Revenues were slightly ahead of those in the prior period, driven by increased royalties from Zytiga® (abiraterone acetate) and Lemtrada® (alemtuzumab). We expect that full year revenue will show single digit percentage growth over the prior year.
Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Ben Atwell/Simon Conway
+44 (0)20 3727 1000
BTG is a growing international specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of liver tumours, severe blood clots, varicose veins and advanced emphysema, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges. To learn more about BTG, please visit: www.btgplc.com.
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