Oasmia Pharmaceuticals is an innovative pharmaceutical development company focused on next‐generation chemotherapy drugs for both human and animal applications.
Oasmia Pharmaceuticals has commissioned Nordea Markets to produce a research report with the aim of providing investors with quality research on the company, which owing to its size might otherwise not receive much attention from the financial markets.
Decision time – Updated 5 March 2018
CHMP opinion expected in April
Oasmia reported an operating loss of SEK 25.2m in Q3 compared with a loss of SEK 34.9m last year. Net sales were SEK 0.7m in Q3, driven by invoiced deliveries of goods to its partner in Russia.
The supplementary data analysis regarding a previous PK study for Apealea has now been completed, in response to questions from the EMA. Oasmia expects to receive a notification from the assessor during April (CHMP will host a meeting on 23-26 April), implying potential market authorisation by the summer. In addition, the process for listing Oasmia’s US subsidiary, AdvaVet Inc, is ongoing and a listing prospectus is expected to be submitted to the SEC soon.
Sales of Paclical in Russia have formerly started, with Oasmia shipping products to its distributor during November and January. However, this is still not fully reflected in revenue, as only manufacturing costs are invoiced and it will later receive share of profit.
We make some adjustments to our near-term estimates to reflect the company’s revenue recognition in Russia and the CHMP opinion on Apealea in April. Our long-term forecasts are unchanged, apart from adjustments owing to FX movements. Assuming the company can deliver on forecasts, we derive a value of share price between SEK 5.7 and SEK 6.8 per share, based on a WACC of 16.2-17.8%.
Activities on several frontiers – Updated 4 December 2017
Quarterly review – Oasmia Pharmaceuticals
Oasmia Pharmaceuticals reported an operating loss of SEK 22.1m in Q2 compared with a loss of SEK 35.9m last year. Net sales were SEK 1.7m in Q2, driven by distribution rights, and the first Paclical order in Russia was shipped in November. The company also reiterated its ambition to list its veterinary assets in the US, which will likely happen during the first half of next year. The registration process for Apealea in Europe has been a bumpy ride. In September, the company requested extra time (clock stop) to compile supplementary analysis of data from a previously conducted pharmacokinetic study, in response to a question from the assessor. Oasmia intends to submit the results as soon as possible, implying an EMA decision in the next few months.
We make adjustments to our near-term estimates to reflect a delayed EMA decision, which pushes sales uptake in the EU and the US. Our long-term assumptions are largely unchanged.
Proprietary drug delivery technology
Oasmia is an innovative pharmaceutical development company focused on next-generation chemotherapy drugs for human and animal applications. Its product pipeline is built on an in-house developed drug delivery technology, XR-17, which enhances formulations by creating micelles that encapsulate the API and improve water solubility without the use of any toxic solvents.
Founded almost 20 years ago, Oasmia has been on a long journey, but it could soon be able to capitalise on its early research efforts. Paclical, its lead asset and a combination of paclitaxel and XR-17, has completed ph III and is awaiting a response from the EMA about market approval.
Updated 4 September 2017, with Quarterly review
Updated 19 June 2017, with impressions from Oasmia’s 2017 CMD
Updated report – 13 June 2017
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This report has been reviewed, for the purpose of verification of fact or sequence of facts, by the issuer of the relevant financial instruments mentioned in the report prior to publication. The review has led to changes of facts in the report. Completion date: 5 March 2018, 08:11 CET