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Marinomed Biotech AG (MARI-AT): Budesolv succeeds in pivotal Phase III trial

Dow Jones received a payment from EQS/DGAP to publish this press release.

goetzpartners securities Limited 
Marinomed Biotech AG (MARI-AT): Budesolv succeeds in pivotal Phase III trial 
 
25-Apr-2019 / 10:35 GMT/BST 
 
*Free to access research and investor meetings in a post-MiFID2 world.* 
 
*This research report is intended for use only by persons who qualify as 
professional investors or eligible counterparties (institutional investors) in 
the applicable jurisdiction, and not by any private individuals or other 
persons who qualify as retail clients.* 
 
*Published to the market and investors on 25th April 2019 @ 8.00am (BST).* 
 
*Marinomed Biotech AG (MARI-AT): Budesolv succeeds in pivotal Phase III trial* 
*Recommendation: OUTPERFORM* 
*Target Price: EUR95.00 * 
*Current Price: EUR79.00 (CoB on 24th April 2019)* 
 
*KEY TAKEAWAY* 
 
Marinomed reported that Budesolv met the primary endpoint of the pivotal Phase 
III trial in allergic rhinitis ("AR"), demonstrating non-inferiority to 
marketed product Rhinocort Aqua. Importantly, this was achieved at about 
one-sixth of the budesonide dose and with a preservative-free formulation. The 
positive outcome allows Marinomed to proceed with the regulatory process, and 
we therefore continue to expect approval in Europe in Q4/2020E or Q1/2021E 
depending on the availability of production slots for validation batches. Our 
fair value remains unchanged at EUR95 per share (c.20% upside) pending detail 
trial data later in Q2/2019E, which should also clarify whether Budesolv met 
the secondary endpoint designed to show a faster onset of action. We see this 
as a key differentiating factor for Budesolv to meet our c.EUR760m peak sales 
forecast (<4% market share). Marinomed intends to sell Budesolv as an OTC 
product, offering the opportunity to leverage the existing global network of 
partners used for its marketed product portfolio. Maintain OUTPERFORM. 
 
*Budesolv met the primary endpoint of non-inferiority vs. J&J's Rhinocort 
Aqua* 
 
Budesolv contains the glucocorticoid budesonide commonly used for allergy and 
autoimmune diseases, reformulated based on the proprietary Marinosolv 
platform. This increases the solubility, thus allowing for the administration 
of a much lower dose. The European Phase III trial (which enrolled 84 
patients, of whom 75 were eligible for the primary endpoint analysis) tested 
Budesolv as a nasal spray for AR, an inflammation of the nasal mucous 
membranes that affects up to 30% of people. The primary endpoint was 
non-inferiority vs. Rhinocort Aqua (budesonide suspension), Johnson & 
Johnson's ("J&J") successful OTC product with 2017 retail sales of $250m in 
the >$12bn AR market. Top-line data suggests that this endpoint was met. 
 
*Secondary endpoint designed to show faster onset of action still outstanding* 
 
Marinomed had planned to differentiate Budesolv through the inclusion of a 
secondary endpoint focused on showing faster onset of relief of minutes rather 
than days. We understand that the company does not yet have sufficient data to 
provide feedback on this endpoint and we therefore look forward to further 
details once the full data is published at the end of Q2/2019E. 
 
*Valuation unchanged pending detailed data later in Q2/2019E* 
 
As highlighted in our recent initiation of coverage report, a positive outcome 
for the Budesolv Phase III trial would lead us to increase the probability of 
success in AR to 85% (from 75%). Since the outcome also provides validation 
for the Marinosolv platform overall, we also intend to increase the 
probability of success for the second Marinosolv asset Tacrosolv (based on 
tacrolimus), specifically, to 20% (from 15%) in allergic conjunctivitis and to 
15% (from 10%) in dry eye disease. In aggregate, these changes would lift our 
fair value to EUR107 per share. 
 
Kind regards, 
 
Brigitte de Lima | Analyst 
 
goetzpartners Healthcare Research Team | Research Team 
 
goetzpartners securities Limited 
 
The Stanley Building, 7 Pancras Square, London, N1C 4AG, England, UK. 
 
T +44 (0) 203 859 7725 | brigitte.delima@goetzpartners.com / 
healthcareresearch@goetzpartners.com 
 
www.goetzpartnerssecurities.com [1] 
 
goetzpartners securities LinkedIn page [2] 
 
Registered in England No. 04684144. 
 
Managing Directors: Dr Stephan Goetz, Martin Brunninger and Ulrich Kinzel. 
 
*goetzpartners securities Limited - Team Members* 
 
Equity Research Analysts - Martin Brunninger, Brigitte de Lima, Chris Redhead, 
Martin Piehlmeier and Kieron Banerjee. 
 
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This research report is intended for use only by persons who qualify as 
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the applicable jurisdiction, and not by any private individuals or other 
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Dissemination of a CORPORATE NEWS, transmitted by EQS Group. 
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803373 25-Apr-2019 
 
 
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(END) Dow Jones Newswires

April 25, 2019 05:35 ET (09:35 GMT)

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