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Research: Healthcare
Shield Therapeutics (STX) has announced a technical update to findings from the AEGIS-H2H post-marketing study. The re-analysis demonstrates that Feraccru/Accrufer is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. We note the product did not meet the primary endpoint of non-inferiority at 12 weeks vs IV iron, but did correct anaemia and maintain Hb levels over the long term phase (as defined by the 40-week extension phase of the trial). While we note AEGIS H2H was not required as a registration study (thus the regulatory status of the product is unaffected by the study), the headline results of long-term Hb correction is comparable to IV iron for chronic conditions of anaemia. We believe this will have positive implications for health economic outcomes, pricing strategies and partnering opportunities. The next key inflection point is a US partnering deal; we expect Accrufer launch later this year once a partner has been found. Our valuation of STX is unchanged at £381.7m or 326p/share.
Written by
Shield Therapeutics |
AEGIS-H2H update – non-inferiority at 24 weeks |
Corporate news |
Pharma & biotech |
7 August 2020 |
Share price performance
Business description
Analysts
Shield Therapeutics is a research client of Edison Investment Research Limited |
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Shield Therapeutics (STX) has announced a technical update to findings from the AEGIS-H2H post-marketing study. The re-analysis demonstrates that Feraccru/Accrufer is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. We note the product did not meet the primary endpoint of non-inferiority at 12 weeks vs IV iron, but did correct anaemia and maintain Hb levels over the long term phase (as defined by the 40-week extension phase of the trial). While we note AEGIS H2H was not required as a registration study (thus the regulatory status of the product is unaffected by the study), the headline results of long-term Hb correction is comparable to IV iron for chronic conditions of anaemia. We believe this will have positive implications for health economic outcomes, pricing strategies and partnering opportunities. The next key inflection point is a US partnering deal; we expect Accrufer launch later this year once a partner has been found. Our valuation of STX is unchanged at £381.7m or 326p/share.
Year end |
Revenue (£m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/18 |
11.88 |
(5.15) |
(1.5) |
0.0 |
N/A |
N/A |
12/19 |
0.72 |
(9.07) |
(7.5) |
0.0 |
N/A |
N/A |
12/20e |
12.66 |
1.14 |
2.0 |
0.0 |
N/A |
N/A |
12/21e |
8.99 |
(4.31) |
(3.2) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
AEGIS-H2H was a 52-week, open-label Phase III study in 242 inflammatory bowel disease patients with mild to severe IDA, randomised (1:1) onto either oral Feraccru or IV ferric carboxymaltose (Ferinject). The trial was a non-inferiority study, with the primary endpoint a non-inferior comparison between Feraccru and IV Iron as showing a 2g/dL improvement in Hb levels or achieving normalisation. Shield has announced that the re-analysis shows the primary endpoint of the study was not met after 12 weeks of treatment on Feraccru (the first phase of the study), although the average increase in Hb levels in Feraccru patients was~2.5g/dL which is clinically significant (vs ~3g/dL for IV). However, at the long-term phase (using the intention to treat population), by week 24, 65% of the Feraccru/Accrufer patients still being monitored had achieved normal levels of Hb, compared with 68% of IV patients. At weeks 24, 36 and 52, the mean increases in Hb levels in those patients still being monitored were 2.93 g/dL, 3.16 g/dL and 2.72 g/dL in the Feraccru/Accrufer arm compared with 2.84 g/dL, 2.70 g/dL and 2.79 g/dL in the IV arm respectively.
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Research: Industrials
Market conditions have affected Tyman’s regional operations in different ways; with revenues recovering now and a settled funding outlook, the COVID-19 challenges appear to have been navigated well so far. The company typically has a seasonal H2 trading bias; the extent to which the recovery to date can be sustained in this important period will be a key determinant of the full year outturn. Other actions taken should also aid the recovery phase. Our estimates remain suspended at this time.