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Futura Medical
AGM statement confirms MED3000 filings on track

Futura Medical confirms the timelines for the regulatory filings for MED3000, its novel erectile dysfunction (ED) treatment, are on track. Dialogues with both the US FDA and European Notified Body have been constructive. The EU Notified Body has begun its review of the supporting documentation and the FDA filing is still expected by end-Q320. There have been no COVID-19 related delays but, in our view, these remain a consideration. We assume the review processes will take a minimum of 12 months in both cases, so have approvals pencilled in for Q421. Commercialisation discussions are expected to start in earnest once the status of the regulatory approvals is known. Our DCF-based model, using conservative assumptions, values Futura Medical at £153.8m, equivalent to 60.9p a share.

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  • 29 Jun 20
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Bonesupport Holding Ab
Swings and roundabouts

SEK 378m in (gross) proceeds from Bonesupport’s directed share issue will help it scale up and maintain necessary investment to drive CERAMENT’s growth trajectory. Bonesupport’s commercially driven strategy is delivering, with investment in new US sales territories converting into enhanced sales and new distributors now in place in key European countries. However, with the impact of the COVID-19 pandemic starting to be felt in Q120, guidance of 40+% annual revenue growth from 2020 will be off a lower base. H120 sales will be negatively impacted by postponed elective surgeries due to reprioritisation of healthcare resources; H220 is currently difficult to assess. Around 70% of proceeds will be directed into commercial activities, principally supporting CERAMENT G US launch (first approval could now occur in late 2020 following the De Novo FDA filing for chronic osteomyelitis in April) and in optimising infrastructure in Europe. We update our valuation to SEK41.5/share, or SEK2.62bn.

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  • 29 Jun 20
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Hutchison China Meditech
General Atlantic invests $100m at 10% premium

General Atlantic, a global growth equity investor, has invested $100m in Hutchison China MediTech (Chi-Med) via a private placement. The new shares, in the form of 4.0m ADS (each equivalent to 5 ordinary shares) are priced at $25.00 per ADS, a 10.4% premium to the prior 30 day volume weighted average price. The fund raise could increase to $200m as it includes a warrant, valid for 18 months, to purchase an additional $100m of ADS at a price of $30.00 (a 32.5% premium to the prior average price).

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  • 25 Jun 20
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Mereo Biopharma Group
Private placement raises $70m (£56m)

Mereo Biophama has successfully raised an impressive $70m (£56m) gross through a private placement with new and current US institutional investors. The fund raise was led by Orbimed and brought in Vivo Capital, Surveyor Capital (a Citadel company), Pontifax Venture Capital, Samsara BioCapital, Commodore Capital, and funds managed by Janus Henderson Investors. Existing investors such as Boxer Capital (Tavistock Group) and Aspire Capital Fund also participated.

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  • 04 Jun 20
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Hutchison China Meditech
ASCO 2020: savo and suru data drives regulatory progress

Hutchison China MediTech (Chi-Med) presented savolitinib and surufatinib data at the American Society of Clinical Oncology (ASCO) 2020 virtual meeting which highlight recent clinical and regulatory progress. Encouraging, albeit limited, data from the SAVOIR trial has contributed to resumption of development plans for savolitinib in papillary renal cell carcinoma (PRCC). Separately Chi-Med announced that its third NDA submission, the China NDA for savolitinib in non-small cell lung cancer with MET exon 14 skipping mutations (MET ex14m NSCLC) has been accepted for review. The company also announced its intention to start a rolling US NDA submission for surufatinib in neuroendocrine tumours (NET) in late-2020 following a positive preNDA meeting with the FDA. Our Chi-Med valuation is £5.08/share or $32.99/ADS.

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  • 04 Jun 20
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Futura Medical
Nearing the critical point in Erectile Dysfunction

Futura Medical is approaching a key point as the first of the regulatory filings for its novel erectile dysfunction (ED) treatment, MED3000, is expected within the next few months. MED3000 is a fast-acting gel that has proven clinical efficacy, a fast onset of action, and an attractive commercial profile. The ED market opportunity is sizeable, especially once MED3000 becomes widely available over the counter (OTC). Optimally addressing the various elements of the demographic segments and needs of the different geographies will, in our view, require careful selection of commercial partners. We expect the partnering discussions to start in earnest once the status of the regulatory approvals is known. Our DCF-based model, using conservative assumptions, values Futura Medical at £153.8m, equivalent to 60.9p a share.

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  • 02 Jun 20
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