PDA

View Full Version : PXS--Pharmaxis Ltd



stolwyk
02-11-2004, 10:42 AM
PXS--PHARMAXIS Ltd.

This is one of the 6 Bio stocks previously selected.

Website: http://www.pharmaxis.com.au/

Chart: http://bigcharts.marketwatch.com/javachart/javachart.asp?symb=AU%3APXS&time=&freq=

Quarterly Report: Outflow: $2.04 mill. Cash: $22.9 mill

There is a trading halt in progress to raise more cash so as to fund completely Phase III of a trial. Current price: 83 cents
______________________________________

Today's AFR- Street Talk:

Pharmaxis goes solo with Aridol

Respiratory disease drug developer Pharmaxis is achieving something few Australian biotechs can claim by taking its asthma diagnosis test Aridol through Phase III trials and funding the whole process itself.

Pharmaxis was in a trading halt yesterday while it raises $15million in a placement through the same broker it used when it floated last year, Wilson HTM. The biotech will not return to the screens until tomorrow, but is expected to pitch the issue at a 10per cent discount to its last close of 83¢, compared with its float issue price of 50¢.

The company's last cashflow statement shows it had $23million in cash at the end of the last quarter, so it is not in dire need of the money. Pharmaxis's strategy, unlike many biotechs, is to fund drug development through each stage, rather than bring in a big pharmaceutical company to pay for the privilege in return for the bulk of the returns.

Assuming the drug has some merit, the longer it can be funded internally, the more valuable the drug becomes to the big companies.

Aridol is but one part of the company's portfolio, and Pharmaxis also has high hopes for the Bronchitol product, a therapeutic treatment for cystic fibrosis and chronic obstructive pulmonary disease.

Aridol is a patented, inhaleable dry powder designed to identify patients with active asthma and provide information on the disease's severity and the effectiveness of treatment. The dose causes the airway to contract and the amount of air a patient can exhale in one second measures the severity of the illness. As it stands, doctors rely on older tests that can be inaccurate and cumbersome.

Asthma is obviously a significant burden on the health system, costing the United States some $US15billion ($20billion) last year and killing 4500 people there and 400 in Australia. Pharmaxis expects to start generating cashflow from Aridol within the next 12 months.
___________________________________________


Gerry
Holds PXS
Readers, please do your own research and you decide if and when to buy, hold or sell any stocks.

stolwyk
02-11-2004, 11:51 AM
27 Sept: media release: BRONCHIECTASIS CLINICAL TRIAL:

http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=343430

Extract:

"Pharmaxis announces positive results from Phase II trial of BronchitolTM Pharmaxis (ASX:PXS) today announced that the Phase II BronchitolTM clinical trial has demonstrated the safety and feasibility of using Bronchitol in longer term Phase III clinical
trials in patients with bronchiectasis, a respiratory disease affecting more than 600,000 people worldwide.

Dr Alan Robertson, Pharmaxis CEO said that results from the study were very impressive.

“The success of this bronchiectasis trial is a very significant milestone in the development
of Bronchitol.

The positive outcome from this exploratory study takes us an important step closer to getting Bronchitol into the marketplace,” he said.

Bronchitol is a patented, inhalable, dry powder that can be administered by a convenient, hand-held, pocket sized device. It is manufactured by Pharmaxis in the company’s TGAapproved manufacturing facility.

Bronchitol is being developed for the management of
various chronic obstructive lung diseases, in particular bronchiectasis, chronic bronchitis and cystic fibrosis.

Brett Charlton, Pharmaxis Medical Director, said: “the positive results from this and earlier studies, and feedback from many patients in the study that their lives were improved after only 2 weeks therapy, is very encouraging in this difficult to treat disease”.

The double blind, placebo controlled, crossover trial enrolled 60 adults aged from 18 to 75 who suffer from bronchiectasis, a form of chronic obstructive lung disease. It commenced in November 2003 and was conducted at hospitals in Sydney and Melbourne in Australia, and Auckland in New Zealand.

A statistically significant improvement in a quality of life score was observed after two weeks treatment with
Bronchitol and statistically significant improvements were also seen in sleep quality as reflected in a ‘sleepiness’ score.

The improvement in quality of life was considered
clinically significant. Patients with an unclear chest at commencement of treatment had a highly significant improvement in their bronchiectasis symptoms score on
Bronchitol compared with placebo.

Out of the 60 patients recruited, 3 withdrew during the study; 2 whilst on placebo and one whilst on Bronchitol. Adverse events occurred with similar frequency on both Bronchitol and placebo treatments.

No serious adverse events were recorded and no deleterious effects on lung function or infections were observed.
The primary objective of the trial was to compare the effects of twice daily treatment of Bronchitol on the disability and handicap associated with bronchiectasis before and after treatment and against placebo.

Disability and handicap was assessed by quality of life and symptom questionnaires, as well as exercise testing. The trial was conducted in accordance with the International Committee of Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).

Bronchiectasis is an irreversible dilation of the main airways to the lungs, commonly accompanied by chronic infection. There are many causes of bronchiectasis and the disease can develop at any age, although symptoms may not be apparent until later in life.

Most patients are affected by chronic cough and phlegm. The symptoms often begin quietly, usually after a respiratory infection, and tend to worsen gradually over a period of years.

Pharmaxis is aiming to have all studies completed to enable submission of a general marketing approval for bronchiectasis with the TGA by 2006.

To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.

ends#
For further information, please contact:
Alan Robertson - Pharmaxis Chief Executive Officer
Ph: (02) 9454 7216 or alan.robertson@pharmaxis.com.au
Released through:
Ashley Rambukwella – Financial & Corporate Relations
Ph: (02) 8264 1004 / m. 0407 231 282 or a.rambukwella@fcr.com.au

About Pharmaxis
Pharmaxis is a developer of innovative pharma

stolwyk
02-11-2004, 11:59 AM
26 Oct: ARIDOL PHASE III ASTHMA TRIAL SUCCESSFUL

http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=347045

Extract:
Pharmaxis (ASX:PXS) is pleased to announce the Phase III clinical trial of AridolTM achieved its endpoints. The trial was designed to evaluate Aridol as a test for asthma.

The positive results mean the company will apply for marketing authorisation later this year in Australia, and early in 2005 in Europe. Subject to regulatory approval, sales of Aridol are
expected to commence in 2005.

The annual revenue potential of Aridol as a management tool for Asthma is estimated to be in excess of $250 million".

02-11-2004, 04:21 PM
Gerry a new record 100%

stolwyk
03-11-2004, 10:20 AM
Placement of $16.5 Million & Share Purchase Plan

Pharmaxis Announces Placement of $16.5 million and Share Purchase Plan
Strong support has enabled Pharmaxis (ASX:PXS) to raise $16.5 million through a fully underwritten placement to Australian institutions and sophisticated investors.

The placement replenishes the company’s cash funds expended on its successful clinical trials during 2004 and therefore allows Pharmaxis to proceed with a new international Phase III trial for BronchitolTM in 2005.

Pharmaxis will issue 22 million new fully paid ordinary shares at 75 cents, an 8.9 per cent discount to Pharmaxis’s volume weighted average share price over the past 30 days. The shares to be issued will rank equally with existing ordinary shares in the capital of the
company.

The settlement of the placement is fully underwritten by Wilson HTM Limited and is scheduled to take place in two tranches. Sale of the first tranche of 16.2 million shares closes on 12 November 2004, while the issue of the second 5.8 million share tranche is
subject to shareholder approval at a general meeting intended to be held on 13 December 2004.

A share purchase plan will be offered to all shareholders who hold shares on 8 November 2004 and will enable them to purchase up to $5,000 worth of fully paid ordinary shares at the institutional placement price of 75 cents. The share plan offer opens on 10 November
and closes on 3 December 2004.

Alan Robertson, chief executive officer of Pharmaxis said “We are particularly delighted with the strong support from the participating institutions. The proceeds of the placement and the share purchase plan will give the company cash reserves of more than $39 million,
allowing us to embark on the international Phase III clinical trial for Bronchitol and at the same time prepare for the marketing of our asthma management test AridolTM.

The placement follows successful results from Pharmaxis’s Phase II clinical trial of Bronchitol in bronchiectasis and its Phase III Aridol asthma trial. Aridol is the first management tool for asthma and offers an improved health outcome for asthma patients.

Bronchitol is a patented, inhalable, dry powder that can be administered by a convenient, hand-held, pocket sized device. Bronchitol is being developed for the management of various chronic obstructive lung diseases, in particular bronchiectasis, chronic bronchitis and cystic fibrosis. It is manufactured by Pharmaxis in the company’s TGA approved manufacturing facility in Sydney.

To find out more about Pharmaxis, go to http://www.pharmaxis.com.au
__________________________________________________ _____

stolwyk
19-11-2004, 02:28 PM
PRESENTATION:
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=350403

stolwyk
19-11-2004, 03:13 PM
Pharmaxis Establishes Level One American Depositary Receipt (ADR) Program:

http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=349461

Extract:
A Level One ADR Program facilitates the purchase of Pharmaxis shares by US investors.

Under the program, one ADR is equivalent to 15 ordinary shares of Pharmaxis.

The ADR’s trade in the US over-the-counter (OTC) market under the symbol PHMXY (CUSIP number
71715J105).

stolwyk
22-11-2004, 10:02 AM
Pharmaxis files Aridol IND in the USA:
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=350565

Extract:
"Alan Robertson, Pharmaxis chief executive officer said that the filing of the IND was an important event in the continuing globalisation of Aridol: “The recently completed Australian Aridol trial allows us to apply for marketing authorisation in Europe and Australia.

This study has been designed to extend our authorisation to the American market,” he said.
“The filing of the IND represents the culmination of a significant effort by very many people and is indicative of the quality and expertise of the team we have assembled. The results
from this trial and the recently completed, successful Phase III Australian trial will form the basis of a marketing application to be submitted to the FDA in 2005.” said Dr Robertson.

The Phase III clinical trial will be conducted over ten sites in the US and will recruit 130 subjects. The objective of the trial is to determine sensitivity and specificity of Aridol with respect to clinical diagnosis of asthma".

stolwyk
25-02-2005, 01:22 PM
23 Dec, 2004:
US FDA Grants Approval For Aridol Phase III Trial:
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=354608

18 Jan: Applies for Regulatory Approval to market Aridol
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=356321

9 Febr: Pharmaxis to Commence UK Trial in Cystic Fibrosis
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=358485

23 Febr: US FDA Grants Bronchitol Orhpan Drug Status
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=360322

25-02-2005, 03:45 PM
Gerry still a one way B.S.I see. Far better you leave this for Hot Copper

stolwyk
04-03-2005, 11:32 AM
2 March: Expands senior management team.
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=361578

Bought on 17 Sept 2004 for 84 cents; now $1.30

stolwyk
08-03-2005, 12:49 PM
8 March: Updated Investor Presentation:

http://stocknessmonster.com/news-history?S=PXS&E=ASX&Year=2005

stolwyk
15-04-2005, 11:47 AM
March 31 quarterly report:

http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=366218

Cash $36.9 mill

msgoldenhair
22-06-2005, 06:21 PM
PXS is having a good run atm...nice chart...apparently US investors are buying in on

stolwyk
22-06-2005, 08:02 PM
Yes, I am very pleased with it.

There is a somewhat constant push, sometimes slow but then picking up speed.

See how we go.

Gerry

stolwyk
28-06-2005, 11:50 AM
Hit $1.85, retraced, now $1.73

Graph still steep:

http://bigcharts.marketwatch.com/javachart/javachart.asp?symb=AU%3APXS&time=&freq=

STO was 100, now 83

stolwyk
20-07-2005, 10:51 AM
US FDA GRANTS BRONCHITOL ORPHAN DRUG STATUS FOR
TREATMENT OF CYSTIC FIBROSIS


http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=375529

stolwyk
29-07-2005, 03:08 PM
Commitments Test Entity - Fourth Quarter Report

Outflow: $3.05 mill

Cash: $33.4 mill





Share price: 1.86

stolwyk
17-08-2005, 12:38 PM
Quarterly Report to Shareholders
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=378288

stolwyk
23-08-2005, 12:45 PM
Lists ADRs on NASDAQ

http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=378990

"Pharmaxis Ltd (ASX:PXS), announced today that it has received approval from NASDAQ to list its American Depositary Receipts (ADRs) on the NASDAQ National Market under the symbol PXSL (CUSIP number: 71715J
10 5).

No new shares will be issued in conjunction with the listing and one ADR will continue to be equivalent to 15 Pharmaxis ordinary shares. The Bank of New York remains the depositary bank".

Share price: $2.07

stolwyk
29-08-2005, 12:14 PM
http://www.pharmaxis.com.au/


Yesterday, Gliontos on H/C referred to:

http://biz.yahoo.com/prnews/050826/to162.html?.v=9

Extract:
Aug. 26: PATCH: "We have enjoyed a phenomenal growth rate from our share ownership in our pharmaceutical investment and we would expect that the value of our investment to receive a significant boost from successful clinical results next week."

Comment: He is referring to PXS. Normally he should'nt be making those remarks.

Patch is the second largest shareholder in PXS.

Topped up at $2.24 this morning. Now $2.32 (+14).

We'll see what these PXS results will be. Thanks Gliontos!

Gerry
Readers, please do your own research and you decide if and when to buy, hold or sell any stocks.

stolwyk
31-08-2005, 11:43 AM
Bronchitol Cystic Fibrosis Trial Results Positive

http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=380284


Extract:

"Pharmaxis has received Orphan Drug Status from the Food and Drug Administration (FDA) for Bronchitol in cystic fibrosis.

Pharmaxis plans to present additional data from the study at the internationally important 19th Annual North American Cystic Fibrosis Conference to be held in Baltimore, MD in October".

Share price: $2.28

stolwyk
01-09-2005, 10:03 AM
$2.68 on the Nasdaq. See what happens here today

Gerry


This arose from last post on previous thread:



Posted - 29/08/2005 : 1:14:50 PM
----------------------------------------------
http://www.pharmaxis.com.au/


Yesterday, Gliontos on H/C referred to:

http://biz.yahoo.com/prnews/050826/to162.html?.v=9

Extract:
Aug. 26: PATCH: "We have enjoyed a phenomenal growth rate from our share ownership in our pharmaceutical investment and we would expect that the value of our investment to receive a significant boost from successful clinical results next week."

Comment: He is referring to PXS. Normally he should'nt be making those remarks.

Patch is the second largest shareholder in PXS.

Topped up at $2.24 this morning. Now $2.32 (+14).

We'll see what these PXS results will be. Thanks Gliontos!

Gerry
Readers, please do your own research and you decide if and when to buy, hold or sell any stocks.

stolwyk
27-09-2005, 08:13 PM
Share price:$2.81 (+21) Turnover: 368k shares.

http://bigcharts.marketwatch.com/javachart/javachart.asp?symb=AU%3APXS&time=&freq=

STO=91

At this stage, some care is needed in case it retraces.


Gerry

stolwyk
04-10-2005, 07:34 PM
Share price $3.12.

Having bought it for 84 cents on 17 Sept. 2004 (See page 1), it has proven to be an excellent investment, sofar.


Gerry

stolwyk
18-10-2005, 09:15 PM
INVESTOR PRESENTATION:

http://stocknessmonster.com/stock-quote?S=PXS&E=ASX

stolwyk
07-11-2005, 07:04 PM
Research report from Wilson:

Global Capital Raising to transition to a Global
Speciality Pharmaceutical Company

http://www.pharmaxis.com.au/library/PXS20051005.pdf

Extracts:
"We have increased our valuation of PXS to $488M as the capital raising reduces the risk profile of the company. The additional capital is to be raised via an IPO in the US and a placement n Australia. We believe there is significant upside to our valuation as the company overcomes various clinical, regulatory and commercialisation hurdles.

Our valuation in the next 12-24 months can increase by approximately $333M. Moreover, for each 10% penetration Bronchitol makes into the cystic fibrosis market over and above our current peak share forecast of 20%, our valuation increases by $82M".

"It is important to note that Bronchitol will probably be used in far more indications than we are currently forecasting. The drug clears mucus from lungs in a manner that does not rely on complex biochemical pathways. As such we believe other uses can include treating conditions such as:
o Pneumonia
o Severe lung infections which lead to or are caused by build up of mucus in the lungs.
The above point cannot be emphasised enough. Bronchitol clears mucus from lungs.

This capital raising gives the company the ability to develop the product for a range of other applications, increasing the upside risk to valuation".

To ensure rapid adoption of Aridol in the global market, PXS is conducting 18 international clinical trials around the world. These trials are not paid for by PXS, but PXS receives the intellectual property arising from these investigations.

These trials are typically run by key opinion leaders, keen to determine whether Aridol is effective in the treatment/management of various respiratory diseases/indications. These key opinion leaders would be instrumental in the development of protocols for the use of
Aridol by general practitioners. Of course, the fact that key opinion leaders are conducting these trials, increases our confidence that awareness of the product will lead to rapid adoption of Aridol".

stolwyk
14-11-2005, 01:49 PM
Bronchitol Granted Orphan Drug Status in Europe

http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=390188

stolwyk
15-11-2005, 06:10 PM
AGM Presentations

http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=390447

COLIN
21-06-2010, 04:15 PM
Trading Halt, pending announcement of results from their second international Phase III trial of the patented Bronchitol in patients with cystic fibrosis. Likely to be negative or positive? Fisher Funds appears to have great faith in the ability of this company to deliver - Barramundi (BRM on the NZX) had over 10% of its portfolio in PXS at 31/3/10.

(I was surprised to find that there have been no posts specifically on this thread since the late Gerry was still with us, although PXS has probably been commented on in other threads re Biotechs)

floyd
22-06-2010, 10:23 AM
i've held pxs since the 80c days, sold and brought a couple of times but going back 6-7 posts in this thread i notice its was 3.14 in 2005........ 5 years later we're still here. heres hoping the 2nd lot of results are just as positive as the 1st and pxs can get regulatory approval.

COLIN
23-06-2010, 10:18 PM
i've held pxs since the 80c days, sold and brought a couple of times but going back 6-7 posts in this thread i notice its was 3.14 in 2005........ 5 years later we're still here. heres hoping the 2nd lot of results are just as positive as the 1st and pxs can get regulatory approval.

Announcement out today, and seems positive. So, why the extremely adverse market reaction? I haven't studied the announcement closely (been away from home, most of the day) but I am greatly puzzled.

Huang Chung
23-06-2010, 10:58 PM
Announcement out today, and seems positive. So, why the extremely adverse market reaction? I haven't studied the announcement closely (been away from home, most of the day) but I am greatly puzzled.


The bit that says "The primary endpoint comparing the FEV

1 mL improvement of Bronchitol to control over the 26 weeks, narrowly missed statistical significance (p=0.059)." seems to imply that they didn't quite reach the threshold which would indicate that the test results weren't a fluke. I reckon that's why they were hammered Colin.

COLIN
24-06-2010, 03:32 PM
The bit that says "The primary endpoint comparing the FEV

1 mL improvement of Bronchitol to control over the 26 weeks, narrowly missed statistical significance (p=0.059)." seems to imply that they didn't quite reach the threshold which would indicate that the test results weren't a fluke. I reckon that's why they were hammered Colin.



Thanks for that explanation, HC. I must admit these biotech reports get a bit technical for me at times.
So, what do they do now - start all over again, in the hope of exceeding the threshold next time? That would take another six months, or more, and might not achieve any better result. Or do they just walk away from trying to prove Bronchitol's efficacy for this particular purpose and concentrate on its other proven benefits?

Huang Chung
24-06-2010, 08:08 PM
Thanks for that explanation, HC. I must admit these biotech reports get a bit technical for me at times.
So, what do they do now - start all over again, in the hope of exceeding the threshold next time? That would take another six months, or more, and might not achieve any better result. Or do they just walk away from trying to prove Bronchitol's efficacy for this particular purpose and concentrate on its other proven benefits?

I guess they'll see what the FDA has to say, but they might have to do even more trials, which come and a cost, both in time and in dollars.

Still, a better outcome than if the tests indicated little or no patient benefit.

COLIN
19-10-2010, 05:20 PM
Well, they took off once they announced on 6 October that the FDA had approved Aridol. And up nearly 10% today, when the overall market has been rather tepid.

What I don't understand, though, is the odd-looking nature of the individual share parcels that are being bid/offered/sold, e.g. the 1206's and the small trades. Is it staff exercising their options, or computer bots, or what?

COLIN
19-10-2010, 05:51 PM
What I don't understand, though, is the odd-looking nature of the individual share parcels that are being bid/offered/sold, e.g. the 1206's and the small trades. Is it staff exercising their options, or computer bots, or what?

Also noticed similar string of repetitive figures on another bio-tech which had a bit of a lift today - ACR - where there seem to be several "1,413" parcels strung out on the buy side.

Is it just my suspicious mind?

Voltaire
25-05-2011, 12:13 PM
PXS down over 70% on negative Bronchitol result.

Don't hold PXS but ditched NZ BRM shares which had PXS recorded as about 12% of holding (prior to this result)

Huang Chung
25-05-2011, 06:04 PM
And PXS wasn't a small cap either.

Lots of hurt on this one unfortunately.

winner69
25-05-2011, 07:33 PM
A stolwyk ramp of old ..... and nobody took the bait on this time ... or least nobody replied to his posts

he was a legend that stolwyk ... had some good stocks in his heyday

Hope the sharetrader forum in heaven has been as good for you as this one was

buns
25-05-2011, 07:38 PM
This is a fisher funds holding to right?

Will ber her last bio tech i suspect

Arbitrage
26-05-2011, 09:36 AM
Yes it is a Fisher holding. See the discussion under BRM Barramundi on the Sharetrader NZX forum.

derek.zoolander
27-05-2011, 07:34 AM
From the fisher funds website-

Obviously the drop the in the Pharmaxis share price yesterday was a tremendous disappointment to us and a massive surprise to many investors in the company.

In short it seems that the European Medicines Authority (the regulator) is unlikely, at least at the first hurdle, to grant marketing authorisation for Pharmaxis to market its drug Bronchitol for Cystic Fibrosis in Europe. As the share price response indicates this was a massive negative surprise not only to us but to the analyst and investor community at large.

Assuming that Bronchitol receives a formal negative decision when the regulator meets again in late June (not definite), we believe Pharmaxis will probably appeal the outcome.

This appeal process would represent a delay of 6 months on the original timetable for a European marketing approval, assuming a successful outcome.

The chances of success in the appeal process are difficult to ascertain. Since January 2009 8 drugs have appealed negative decisions, with 3 of those appeals proving successful. PXS believes it will eventually prevail and receive European marketing approval.

The challenge for us right now is to assess what this means for the company’s future. Clearly the risk of ultimate failure to achieve this marketing authorisation has gone up although the key issues raised would seem to be addressable in any review process.
Unfortunately, for now though, the risk faced by PXS has risen substantially we have decided to exit our position in the company and watch the review process from the sidelines.

Whilst the balance of probabilities suggests the company may be successful a major negative shock of this scale leads us to believe this is the prudent approach.

Frank

winner69
27-05-2011, 07:53 AM
From the fisher funds website-

Obviously the drop the in the Pharmaxis share price yesterday was a tremendous disappointment to us and a massive surprise to many investors in the company.

In short it seems that the European Medicines Authority (the regulator) is unlikely, at least at the first hurdle, to grant marketing authorisation for Pharmaxis to market its drug Bronchitol for Cystic Fibrosis in Europe. As the share price response indicates this was a massive negative surprise not only to us but to the analyst and investor community at large.

Assuming that Bronchitol receives a formal negative decision when the regulator meets again in late June (not definite), we believe Pharmaxis will probably appeal the outcome.

This appeal process would represent a delay of 6 months on the original timetable for a European marketing approval, assuming a successful outcome.

The chances of success in the appeal process are difficult to ascertain. Since January 2009 8 drugs have appealed negative decisions, with 3 of those appeals proving successful. PXS believes it will eventually prevail and receive European marketing approval.

The challenge for us right now is to assess what this means for the company’s future. Clearly the risk of ultimate failure to achieve this marketing authorisation has gone up although the key issues raised would seem to be addressable in any review process.
Unfortunately, for now though, the risk faced by PXS has risen substantially we have decided to exit our position in the company and watch the review process from the sidelines.

Whilst the balance of probabilities suggests the company may be successful a major negative shock of this scale leads us to believe this is the prudent approach.

Frank

WOW .... not taking the punt on the near 50/50 chance of getting approvals

Now they concentrate on investing in soemthing new .... or buying more of what they have

Some would say this is the time to buy PXS -- esp the multitudes who believ Fisher has a track record of buying high and selling low

Suppose Roger not impressed

buns
27-05-2011, 08:20 AM
Put it all into ACL/another bio tech to get your 70% back instantly!

buns
27-05-2011, 08:21 AM
I'm kind of joking

And hoping a little bit as an ACL shareholder.

Stranger_Danger
27-05-2011, 08:35 AM
Carmel has been great to me over the years, but I don't know about this one.

I find it really hard to see a stock like PXS as anything other than a gambling chip. I don't know the science, I'm not wired into what a regulator may decide in a year, I don't know whats going on in other labs around the world that may be doing a similar thing, better.

I'm interested by the magnitude of the fall, but haven't got a clue how to value it or get a strong clue about their future prospect. I think Carmel can keep this one.

derek.zoolander
27-05-2011, 08:46 AM
Yeah agree that the stock looked like one glorified gambling chip- surprised that an investment fund such as fisher would buy so much into a stock like that, where essentially the majority of the value was hinged on one, non market ready drug. Easy to say all this in hindsight though...

buns
27-05-2011, 09:30 AM
Again, some ticked off (unlucky investors) are getting away from the point.

FF knew the risk in PXS. And they were not at the ‘gambling’ stage at all. It is really the only hit or miss stock in their portfolio, its risk profile coupled with the safety of its other holdings allowed it to hold this.

Don’t discount Bio techs all together, a lot do, hence the great investment opportunity. They can really get smashed at times for no reason (right now) and really give investors great risk reward opportunities. I hope Fisher buys undervalued Bio techs going forward IF THEY FIT the portfolios risk profile.

You should read over how a listed bio tech goes from A to B.

I would say a drug with anything below a stage 3 success is a gamble. PXS was past this.

The reward in a bio tech can quite often be an instant monopoly.

An example of another bio tech. ACL (I’m not trying to market my holdings, but it’s the only one I know well enough to use an example)

Background:
• ACL have developed fondaparinux (Fonda), the first generic version of the near half billion dollar (US) drug Arixtra, an anti coagulant used to treat blood clots
• Fonda is a copy (generic) of a branded drug by GSK called Arixtra. Arixtra has global sales of USD450m annually and is growing at 15-20% pa in the US. Sales should reach 500m is 2011 and it has the potential to reach 1b over time. While first generics normally take 40-50% market share form the branded product, ACL can expect to take +50% market share from Arixtra. Late 2012 the Euro patent is free, hence Fonda can be sold to larger markets again.

Approval
• ACL submitted an ANDA giving it rights to quicker approval
• Both ACL and Dr Reddy’s (marketing partner) have publicly announced that they believe all steps in the FDA ANDA process are complete satisfactorily and that the next communication they will receive will be the approval letter.
• Interestingly there are 10 steps in the ANDA approval process that the FDA staff must follow. And the final of these is to check the manufacturing plants to ensure they meet various safety standards. This was completed in January 2010 and as such there are no more steps in the process. Theoretically ACL are now simply waiting on the FDA’s internal decision making process.

Monopoly
• The 2011 average ADNA approval time its expected to hit 35 months. So assuming someone knew how to replicate this very hard and expensive to make drug, the 2 in the market right now will enjoy a monopoly for at least 4 years.

Valuation
• I don’t want to sell ACL in this post, but instead show the upside in these bio techs. ACL for instance is trading at 60c, using a PE of around 12 or EBITDA/EV around 5/6 they should hit about $1.50 just on the fonda revenues. Taking this into account, if Fisher had a portfolio of different stage bio techs instead of just one, she would only need maybe 1/3 (late stage 3+ companies) to come to break even.

Stranger_Danger
27-05-2011, 10:08 AM
Yeah agree that the stock looked like one glorified gambling chip- surprised that an investment fund such as fisher would buy so much into a stock like that, where essentially the majority of the value was hinged on one, non market ready drug. Easy to say all this in hindsight though...

I'm not saying it in hindsight. I've never had this stock on my radar before.

I'm saying it looking forward - ie, forgetting the fall and the past, the business at todays price looks like a gambling chip. And I don't mean that as an insult - to me, they're in the business of "finding a business", and that finding effort is utterly dependant on binding rulings by third parties.

If you haven't guessed already, biotech isn't really my thing.

Beagle
27-05-2011, 10:39 AM
WOW .... not taking the punt on the near 50/50 chance of getting approvals

Now they concentrate on investing in soemthing new .... or buying more of what they have

Some would say this is the time to buy PXS -- esp the multitudes who believ Fisher has a track record of buying high and selling low

Suppose Roger not impressedActually I think Fisher were very dumb to sell after a drop of that magnitide but obviously buying high and selling low is one of their special investment "skills" Even dumber still is having 12% of your portfolio in an emerging biotech in the first place. They seem determined to destroy investors value and their reputation is in complete tatters as far as I am concerned.

macduffy
27-05-2011, 11:13 AM
I don't hold PXS - or Barramundi - but I'd have to agree with Roger that having 12% of a portfolio in an unproven biotech doesn't make sense for a fund which purports to be an Australian growth equities fund. I'm not averse to having a small bet on biotechs from time to time but I treat them as I would an oil and gas or mining explorer, limiting exposure to no more than 5% of my portfolio. CST - currently emboiled in a "contested" takeover - has been good in this respect but I've also had some disappointments. The key is to limit exposure and act quickly to cut losses, admittedly not easy when holding such a big chunk as Fishers have/had here.

drillfix
27-05-2011, 11:36 AM
Well worded there Macduff.

And a great description of a very balanced discipline that is and example for many newbs to read.

777
27-05-2011, 12:21 PM
Has it been considered that perhaps it was the selling by FF that caused the large drop?

macduffy
27-05-2011, 01:00 PM
Has it been considered that perhaps it was the selling by FF that caused the large drop?

Fishers weren't the only big holder to sell but there's little doubt that the weight of their holding contributed to the extent of the fall.

COLIN
27-05-2011, 02:04 PM
Fishers weren't the only big holder to sell but there's little doubt that the weight of their holding contributed to the extent of the fall.

Ironic that they are up 28% today (at this stage)! Not a good look for Carmel.

Arbitrage
27-05-2011, 03:59 PM
I wonder whether she will mention it in her regular newspaper column on how to invest?

percy
27-05-2011, 06:46 PM
I don't hold PXS - or Barramundi - but I'd have to agree with Roger that having 12% of a portfolio in an unproven biotech doesn't make sense for a fund which purports to be an Australian growth equities fund. I'm not averse to having a small bet on biotechs from time to time but I treat them as I would an oil and gas or mining explorer, limiting exposure to no more than 5% of my portfolio. CST - currently emboiled in a "contested" takeover - has been good in this respect but I've also had some disappointments. The key is to limit exposure and act quickly to cut losses, admittedly not easy when holding such a big chunk as Fishers have/had here.

Sage advice.

Toulouse - Luzern
28-05-2011, 01:47 PM
Hi all,
Good posts on this thread.
I wonder about FFM risk appraisals on PXS and for their AGF and BRM portfolio based on the binary event, approval given to PXS, or approval not given.
As set out earlier in this thread the clinical trial result was marginal...
FFM raised their stake and bought an extra 95,000 PXS at avge of $2.97 in the month before the announcement.
It seems to me that Shrewd Crude expertise may give us an insight on the way this hand was played.
Cheers

COLIN
30-05-2011, 01:13 PM
Up 46% (so far) today! Carmel dear, what have you done! Or what are you doing, may perhaps be more to the point? Shorting, longing, or just lounging?

Beagle
30-05-2011, 01:21 PM
Out spending her millions and could'nt give a #*@K.

winner69
30-05-2011, 02:58 PM
Out spending her millions and could'nt give a #*@K.

Prob spending company money on a new outfit and hairdo .... must look seductive for the next photo shoot

In the SST she was sort of comparing Linkedin to Rakon and admitted that Rakon was pretty expensive when they started buying and was even expensive when they sold

Toulouse - Luzern
02-06-2011, 07:37 PM
WA Today comment:

"The management of the biotech Pharmaxis seem to be much slower than their shareholders in working out what sort of announcements can be material to one's share price."

Read more: http://www.watoday.com.au/business/the-lightbulb-that-failed-at-pharmaxis-20110531-1feoc.html#ixzz1O6d4IkGi
http://www.watoday.com.au/business/the-lightbulb-that-failed-at-pharmaxis-20110531-1feoc.html

drillfix
02-06-2011, 08:31 PM
Haaa, What a Joke.

Sounds more like the need of a Head being Lopped off from one of the board and presented on a platter at a shareholders meeting.

I am surprised such news or presented information and reaction does not incriminate them under the Corporate Governance chapters.

COLIN
24-10-2011, 11:00 AM
Good news from Europe.

About a 50% gain on the pre-open.

drillfix
24-10-2011, 12:06 PM
Good news from Europe.

About a 50% gain on the pre-open.


Wow, huge gap up Colin. Are you holding?

Toulouse - Luzern
24-10-2011, 03:05 PM
Be interesting to see if and how much Fisher Fund Australian Growth unit price lifts with todays PXS trading ...
I am still holding via FFM Aust Growth if they still have a holding ...

winner69
24-10-2011, 07:40 PM
Be interesting to see if and how much Fisher Fund Australian Growth unit price lifts with todays PXS trading ...
I am still holding via FFM Aust Growth if they still have a holding ...

,,, said they exited back in May ... and no signs of them buying back in

Toulouse - Luzern
26-10-2011, 03:07 PM
Hi
Ok, the latest unit price (25 Oct 2011) for FFM Australia Growth is NZD 2.2048.
This is up $0.0362 or 1.67% from NZD 2.1686 on 21 Oct 2011.
Other positives besides PXS include;
(1) ASX was up about 80 pips the same day as the PXS news so other FFM holdings were also up
(2) AUDNZD moved positively for NZ based ASX holders although I don't know about FFM hedging of AUD (if any).
(4) PXS is still listed as one FFM Australian Growth stock among about 19 stocks.

From FFM October newsletter on Australian Growth Funds:
Portfolio Holdings - Austbrokers, Bravura, Credit Corp, CSG, Dart
Energy, DWS, Solutions, McMillan Shakespeare, Nanosonics, Nick
Scali, Pharmaxis, Reckon, Retail Food Group, The Reject Shop, Toxfree,
Treasury Group, Universal Biosensors, Vision Group, WHK Group.

winner69
24-04-2013, 04:32 PM
what goes up comes down by the looks of it

40% down today on not getting approvals

Don't think Fishers have this any more

RGR367
14-04-2021, 12:47 PM
Looking good to hit 10 cents again with today's announcement of a cash placement.
And WOW, it's been a while when this thread was updated :D Glad I'm just a couple of month's old to this stock.
GLTAH