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Research: Healthcare
Sequana Medical announced that the American Medical Association has issued six new Category III Current Procedural Terminology (CPT III) codes for the alfapump system. The issue of these codes augments the existing ICD-10 procedure codes and is expected to assist healthcare professionals and insurers in identifying specific procedures related to the alfapump system for reimbursement. This may broaden and facilitate the future US utilisation and reimbursement for the alfapump for the treatment of recurrent and refractory ascites (RRA) on regulatory approval. Sequana had submitted a Premarket Approval application to the US FDA on 27 December for the alfapump device and we remain confident that there is a high likelihood of a positive regulatory approval decision in H224, given the robust efficacy data from the POSEIDON North American pivotal study.
Sequana Medical |
New CPT III codes to support reimbursement |
Reimbursement update |
Pharma and biotech |
5 January 2024 |
Share price performance
Business description
Analyst
Sequana Medical is a research client of Edison Investment Research Limited |
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Sequana Medical announced that the American Medical Association has issued six new Category III Current Procedural Terminology (CPT III) codes for the alfapump system. The issue of these codes augments the existing ICD-10 procedure codes and is expected to assist healthcare professionals and insurers in identifying specific procedures related to the alfapump system for reimbursement. This may broaden and facilitate the future US utilisation and reimbursement for the alfapump for the treatment of recurrent and refractory ascites (RRA) on regulatory approval. Sequana had submitted a Premarket Approval application to the US FDA on 27 December for the alfapump device and we remain confident that there is a high likelihood of a positive regulatory approval decision in H224, given the robust efficacy data from the POSEIDON North American pivotal study.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
0.4 |
(24.4) |
(1.36) |
0.0 |
N/A |
N/A |
12/22 |
0.9 |
(30.9) |
(1.37) |
0.0 |
N/A |
N/A |
12/23e |
0.7 |
(31.8) |
(1.14) |
0.0 |
N/A |
N/A |
12/24e |
1.8 |
(33.1) |
(1.17) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
CPT codes provide US healthcare professionals and insurers with a method of identifying medical services and procedures for reimbursement. While existing ICD-10 procedure codes, as discussed in our prior note, provide a primary basis for US alfapump reimbursement, the additional CPT codes help clarify the instances where reimbursement for alfapump-related procedures can occur. CPT III codes are temporary codes specifically assigned to new and developing technologies, procedures and services. These codes are also intended to be used by health agencies for data collection to potentially substantiate more widespread usage of the new emerging technology, procedure and/or service to justify the establishment of a permanent (Category I) CPT code.
The six newly added CPT III reimbursement codes (0870T, 0871T, 0872T, 0873T, 0874T, 0875T) will be effective from 1 July 2024 for procedures related to the alfapump system, including the implantation, replacement, revision, removal and programming of the alfapump system, and replacement of the associated indwelling and/or peritoneal catheters.
We believe that US approval of the alfapump would mark a pivotal shift in Sequana’s commercial profile, given the strong market need for improved treatments for RRA that can boost patient quality of life, particularly in light of the rising prevalence of non-alcoholic steatohepatitis. We also note that in addition to the alfapump in RRA, the company’s Direct Sodium Removal (DSR) technology represents a novel approach for treating diuretic-resistant chronic heart failure and/or cardiometabolic syndrome and, with early positive efficacy data in the non-randomized cohort of the US MOJAVE Phase Ib/IIa study, we await progression of this trial to the randomized cohort phase in the coming weeks following a review of data by the study’s independent Data and Safety Monitoring Board.
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Research: Consumer
Topps Tiles’ (TPT’s) Q124 update indicates that trading was a little softer towards the end of the quarter than was reported for the first eight weeks, ie at the time of the FY23 results. However, the end of Q124 had a more challenging comparative than the start of the period since TPT enjoyed stronger sales as Q123 progressed. The ongoing revenue weakness is not surprising given the weak repairs, maintenance and installation market backdrop, but management believes the strength of its offer and customer service has translated into further market share gains in the period. Our forecasts for FY24 and FY25 are unchanged. The shares continue to look attractively valued versus historical multiples, relative growth rates and expected profitability.