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Last edited 7 months ago

28-Oct-2019:  FDA Provides Guidance on Bronchitol Approval Steps - FDA Expected to Complete Review Q2 2020

24-Oct-2019:  Pharmaxis Cancer Drug Progressing in Clinic

18-Oct-2019:  Pharmaxis FY2019 Annual Report

17-Oct-2019:  Pharmaxis Receives $6.2m R&D Tax Incentive

26-July-2019:  Investor Presentation

25-July-2019:  Quarterly Shareholder Update - June 2019

 

Disclosure:  I have been in and out of PXS for a number of years.  I do currently hold some PXS shares.  I did see them a few years back as possibly the next Acrux (ASX:ACR) back when Acrux was flying - they got over $4/share in 2012 - and are now back down to about 22 cents/share - however the milestone payments tended to take longer than expected with Pharmaxis and so the expected capital returns (or special dividends) to shareholders never came, and the PXS SP remained stubbornly in a trading range between 25c and 35c from January 1st 2016 to June 30 this year (2019), mostly staying close to the lower end of that range.  I did trade the range a few times, but I was out for most of the last year.  I've recently got back in because they've dropped below 25c - getting down to 18c in August and again in September, but are now starting to trend up again (trading at 21c as I write this, up 1c from Friday's 20c close) and their newsflow has started to increase again, as you will see from all the October news releases above.  Obviously highly speculative, but they have a drug for cystic fibrosis (CF) called Bronchitol that is approved and selling in Germany, Italy, Greece and Nordic countries by Chiesi (under license), in certain other European countries and in Russia by specialist distributors, and by Pharmaxis themselves in Australia and smaller countries.  They also have Aridol, used to diagnose Asthma, Aridol is approved and sold in the USA, Australia, South Korea and a number of European countries.  They recently received Canadian approval for Aridol also (in June 2019).  They have plenty of other drugs in various stages of development, as can be seen in their presentation that is linked to above, and they don't have the same regulatory risk that Acrux had with Axiron, their testosterone replacement therapy, where Acrux thought their target market was a LOT bigger than what it ended up being.  What killed off the hype with Acrux was the realisation that their flagship drug Axiron will likely only ever be approved for the treatment of medically diagnosed hypogonadism resulting in low testosterone in adult males.  That market is a lot smaller than what they had previously perceived to be the total addressable market for that drug.  It also meant that the remainder of the big milestone payments that Eli Lilly were going to pay to Acrux will likely never be paid, or they'll be years away, because they were linked to sales milestones that were based on that previous concept of Axiron's total addressable market.  The issue with otherwise healthy males taking testosterone supplements is that it can possibly increase their risk of heart attacks and strokes.  The FDA was not convinced that the benefits outweighed the risks except in limited cases like medically diagnosed hypogonadism.  I made plenty of money in Acrux, and then I lost money when the FDA killed the dream.  Pharmaxis is a different kettle of seafood, but there are clearly still risks.  They are a biotech who are pumping a lot of money back into R&D, are still involved in a number of trial and regulatory processes, and only have two of their drugs currently in the marketplace.  There is always plenty of potential, especially if you read the material produced by the company themselves (such as their own investor presentations), and they won't highlight the risks except in the opening or closing disclaimer and in other smallprint, so buyer beware!  DYOR!  However, there are a few people here with higher than average risk appetites, so perhaps this may be of interest to some.

Wow - that was a longer than usual "Disclosure" statement.

 

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