The Cyclopharm Limited (ASX: CYC) share price was sent soaring today after the company announced a business update.
Cyclopharm shares went as high as 14.41% in afternoon trade before closing 6.78% up at $2.52 per share.
What Cyclopharm does
Cyclopharm is an ASX-listed radiopharmaceutical company headquartered in New South Wales. It currently has a market capitalisation of just over $203 million.
As stated on the company's website, "the company's mission is to provide nuclear medicine and other clinicians with the ability to improve patient care outcomes."
The health company aims to achieve this objective through the provision of its core radiopharmaceutical product, Technegas, which is used in functional lung ventilation imaging.
What happened?
Today, the Cyclopharm share price went soaring after the company announced an update on its progress towards gaining United States Food and Drug Administration (USFDA) approval. The company needs USFDA approval in order to begin sales of Technegas, its flagship product, in the US.
The company announced that its phase 3 trials have met their Primary and Secondary Efficacy Endpoints in September of last year. As such, it will continue its ongoing "positive" dialogue with the USFDA in order to get its approval of Technegas.
Based on these discussions, the company remains highly confident the approval process is on track to be completed in the second half of FY21.
Cyclopharm also updated its guidance for FY20 revenue. The company stated that despite the challenges of COVID-19, revenue is expected to be in line with that of FY19, which was approximately $14 million.
US market entry
With the impending approval of Technegas, Cyclopharm has begun undertaking activities to ensure it is well placed to rapidly roll out its product. These activities include building inventory reserves, finalising agreements for third party distribution, service and installation, and administrative support.
According to Cyclopharm, the existing market for nuclear medicine ventilation in the US is estimated to be roughly US$90 million annually.
Based on Cyclopharm's experience in the Canadian market, it remains confident that Technegas can achieve a 50% share of the USA market over 2 to 3 years, with an 80% share representing around 480,000 procedures per annum achievable over a 5 to 7 year period.
