- Medical device developer PolyNovo witnessed increased revenue from NovoSorb BTM sales in all direct markets.
- PolyNovo stated that the hernia program has now several prototypes to address the market and regulatory requirements.
- The Company has plans to enter the EU and Middle East markets via distributors.
ASX 200-listed medical device player PolyNovo Limited (ASX:PNV) updated the market with its half-year results for the period ending 31 December 2020.
While the COVID-19 pandemic has impacted second-quarter sales in the US, the Company has achieved many new account acquisitions. With these acquisitions, PolyNovo is well-positioned to accomplish increased sales once hospitals and surgeons increase surgical capacity.
Besides, PolyNovo continues to expand its global direct sales team. The US sales team continues to rise, driving new account acquisitions and servicing incoming demand from surgeons to adopt NovoSorb BTM.
Let us dive deeper and discuss the half-year performance of PolyNovo in detail-
Key initiatives and achievements
During the half-year 2021, the key initiatives and achievements by PolyNovo included-
- The regulatory approval and market launch of NovoSorb BTM (Biodegradable Temporising Matrix) in Benelux, Greece, Finland, Norway, Sweden, Taiwan, and Turkey.
- During the first half of 2021, PNV witnessed increased revenue from NovoSorb BTM sales in all direct markets and the DACH region via its distributor.
- The Company achieved its first sales to distributors in Finland and Taiwan.
- During the period, PolyNovo obtained approval from the US Food and Drug Administration (FDA) for NovoSorb BTM IDE (Investigational Device Exemption) pivotal trial supported with BARDA funding.
The Company also updated that its hernia program now has several prototypes to address the market as well as regulatory requirements. PolyNovo continues to evaluate the optimum product configuration to meet the requirement of surgeons and patients. The Company to further refine the regulatory strategy for ensuring the best pathway to FDA authorisation.
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Moreover, the Company has entered Poland and Turkey markets in January 2021 and Italy in February through distributor appointment.
- Total revenue was reported at A$12.60 million, up by 25.3% on 1H FY20.
- Commercial sales of NovoSorb BTM in the first half rose by 31.2% to A$11.25 million on the prior corresponding period.
- Revenue from the BARDA clinical trial program was reported at A$1.35 million.
- Strong BTM Product Sales in December 2020 exceeded the budget in the US, New Zealand, and Taiwan.
- During the first half of FY21, the Company opened thirty-five new accounts throughout all direct markets.
- In the calendar year 2020, the Company opened 109 new accounts that represent 89% growth as compared to the calendar year 2019.
Outlook: the way forward
The Company anticipates lumpy sales with the restart of elective surgery across the regions, currently challenging to project.
Stock Information: On 23 February 2021, PNV shares were trading at A$2.395, down 0.623% at AEDT 2:29 PM. The Company’s market capitalisation stood at A$1.59 billion.