Neuren Pharma’s Q1 DAYBUE sales disappoint
4DMedical’s CT LVAS technology gets reimbursement in US
Melodiol’s Canadian subsidiary, Mernova, continues to make strong progress
Neuren’s Q1 disappoints
Neuren Pharma (ASX:NEU) slumped by over -10% this morning after revealing that its Q1 2024 net sales took a bit of a hit.
Neuren’s Q1 net sales of DAYBUE (trofinetide) in the US came in at US$75.9 million, below its guidance of US$76 to US$82 million, and far below the Q4 2023 sales of US$87.1 million.
Neuren put the decline down to some seasonal effects, including refills due in January actioned in December prior to the holidays, and reduced Rett clinic days in January.
Plus, Neuren said more patients bailed on treatment during Q1 after a surge of new patients in previous quarters.
But the company says it’s seeing new patients hopping back on board, with numbers climbing each of the last six weeks.
About a quarter of the 5,000 diagnosed Rett syndrome patients in the US have now kicked off therapy.
And the numbers sticking with the DAYBUE treatment were better than expected — 58% are still on board after nine months of treatment, which is 10% higher than what was seen in clinical trials.
In terms of royalty payments, anticipated payments to Neuren for DAYBUE are:
Q1 2024 royalties of $11.6 million
Full-year 2024 royalties of between $61 million and $70 million plus sales milestone revenue of $77 million
Due to all these factors, Neuren’s full year guidance for net sales in 2024 has been reiterated at between US$370 and US$420 million.
DAYBUE makes traction outside of US
DAYBUE (trofinetide) has received approval from the US FDA as a treatment for Rett syndrome in both adult and pediatric patients aged two years and above.
Neuren has exclusively licensed the global rights for the development and commercialisation of trofinetide to US-based Acadia Pharmaceuticals.
Although DAYBUE is presently only approved in the US, Acadia has been making significant strides in its international expansion efforts.
This includes the acceptance for filing of a New Drug Submission in Canada, with priority review granted, potentially leading to approval by the end of 2024.
Additionally, a pediatric investigation plan (PIP) has been filed with and accepted by the European Medicines Agency, with expectations of submitting a Marketing Authorisation Application in Q1 2025.
Furthermore, a formal meeting with the Japanese regulatory agency (PMDA) to discuss the clinical plan is on the agenda for Q2 2024.
4DMedical’s CT LVAS receives reimbursement in US
Respiratory imaging technology company, 4DMedical (ASX:4DX), announced that its CT LVAS technology has been incorporated into existing Category III Current Procedural Terminology (CPT) codes.
From today, CT LVAS scans conducted in a US hospital outpatient facility for Medicare beneficiaries may be billed to Centers for Medicare & Medicaid Services (CMS) with a reimbursement of US$650.50.
CMS reimbursement opens up access to CT LVAS at more than 4,000 Medicare-certified hospitals nationwide in the US, making this technology compatible with existing CT scanners and accessible to Medicare beneficiaries dealing with lung disease.
Notably, the payment level established by CMS serves as a reference point for private health insurers when setting their pricing, often resulting in higher rates.
The company now has reimbursement for both CT LVAS and XV LVAS, having last year successfully established a new CPT code, identifying the use of XV LVAS at the CMS rate of US$299.
Melodiol continues to make strong progress
Meanwhile, Melodiol Global Health (ASX:ME1) says its wholly owned Canadian subsidiary, Mernova, continues to make strong operational progress in Q2.
In the quarter, Mernova received purchase orders for $1.3m. This strong start to the quarter follows unaudited Q1 revenues of $1.75m, and FY23 revenues of $6.9m.
In recent weeks, Mernova has also achieved further new product launches.
“Mernova continues to deliver strong revenue figures and we are very proud of the team for their ongoing commitment to high quality cannabis,” said Melodiol’s CEO and managing director, William Lay.
“We look forward to generating further purchase orders as new products and formats become available.”
Share prices today:
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