DNB Markets - Isofol Medical: Intensifying precommercial activities
Isofol Medical reported a Q3 operating loss of SEK52m, fairly in line with our forecast loss of SEK49m. The financial position remains solid with end-Q3 cash of SEK421m, which should take the company into 2023e. The next milestone in the ongoing phase III study is when 300 PFS events have occurred, enabling analysis of the data to begin; however, visibility on timing is murky but estimated around end-2021 or early 2022. Top-line data is expected in H1 2022 with a possible approval in H2 2023. The company continues to ramp up its precommercial activities to ensure a swift launch on potential approval. Our estimates are largely unchanged post-Q3 and we reiterate our SEK13–23 fair value.
Isofol Medical reported a Q3 operating loss of SEK52m, a tad higher than our forecast loss of SEK49m. The deviation is explained by less revenue attributable to reimbursements for costs related to clinical development in Japan by partner Solasia (cSEK5m reported versus our estimate of cSEK8m). Isofol Medical has a solid financial position with an end-Q3 cash position of cSEK421m.
Next milestone: 300 PFS events. With the phase III study fully recruited, the next step can commence when 300 patients have suffered an event of either tumour growth or death (i.e. a progression-free survival, PFS, event). Once this has happened, analysis of the data can begin, enabling the top-line readout. Timing of the 300 events depends on disease progression, but the current assessment suggests these should be reached by end-2021 or early 2022, with a subsequent top-line readout expected in H1 2022. Based on this timeline, and given positive data, we could see a filing in H2 2022 and a possible approval in H2 2023. The company has communicated that current financing provides a runway past filing.
Intensifying precommercial activities. In line with previous communication, Isofol Medical is stepping up activities to ensure a swift launch on potential approval. Our take is that the collaboration with Syneos Health is expanding with the recruitment of field-based medical personnel.
Fair value of SEK13–23 reiterated. We have made minor adjustments to our estimates following the Q3 report, which does not affect valuation.
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David Martinsson | Markets | Equity Research | Healthcare
Patrik Ling | DNB Markets | Equity Research | Senior Analyst Healthcare