View Full Version : Alchemia (ACL)
tommy
21-10-2004, 04:57 PM
New drug! UP 49.06%! Lovely baby:):)
tommy
21-10-2004, 05:24 PM
21 October 2004
ASX / MEDIA RELEASE
Breakthrough for Alchemia antibiotic drug discovery technology
Australian biotechnology company Alchemia Limited (ASX: ACL) today
announced a significant breakthrough for the antibiotic stream of its early
stage drug discovery platform.
Independent test results have confirmed that Alchemia’s novel class of
antibiotic compounds have a unique mechanism of action that could
revolutionise the treatment of the most serious hospital-acquired infections.
Alchemia Managing Director Dr Tracie Ramsdale said the results proved that
Alchemia’s compounds were highly active against multi-drug resistant
organisms by specifically acting through an unchallenged mechanism of
action.
“These findings could potentially be the most extraordinary scientific
development in several decades in the fight against a broad range of multidrug
resistant gram-positive bacterial strains,” she said.
“Effectively these test results verify that our compounds are suitable
candidates for treating hospital-acquired infections. In the US alone, the
healthcare bill associated with treating hospital-acquired infections exceeds
$US4.5 billion each year.”
Dr Ramsdale said there were very few novel antibacterials in the global
pipeline targeted at treating multi-drug resistant bacteria in hospitals.
“Not only are there very few antibiotics in development but bacterial
resistance to existing drugs ‘of last resort’ is rapidly increasing – creating a
serious health issue for the international community,” she said.
The recent study was conducted by a world leader in microbial research – the
Antimicrobial Research Centre* at the University of Leeds. The results verified
that Alchemia’s compounds act by inhibiting transglycosylase (TG) enzyme
activity, preventing the bacteria from building new cell walls and resulting in
its eventual death.
Dr Ramsdale said the results marked an exciting scientific breakthrough for
Alchemia as no antibacterial drugs were available for human use that directly
inhibited the TG enzyme.
She said Alchemia would proceed immediately to study the efficacy of its
compounds in animal models of resistant bacterial infections.
“We would expect to receive the efficacy results from the animal studies by
the end of 2004,” she said.
“Once efficacy has been proven we will actively seek to develop this project
with a suitable partner who will undertake the necessary human clinical
trials.”
Alchemia’s antibacterial compounds have displayed significant activity
against clinical isolates of multi-drug resistant Gram-positive bacteria, such
as Staphylococcus aureus (MRSA) and Enterococcal (VRE).
These exciting new results will be presented by Alchemia on October 27th at
the major US Biotechnology Conference hosted by Rodman and Renshaw in
New York.
ENDS
tommy
21-10-2004, 05:26 PM
Just sold my entire holdings @0.77, was too good to let this pass[:p]
Will get back into this company again when it gets cheaper in the future, as biotechs tend to be quite price volatile.
Happy trading all:D
tommy
21-10-2004, 06:09 PM
UP 64.15%....WTF?!
Think I sold mine too early[V]
tommy
21-10-2004, 07:30 PM
Closed at $0.830, a 56.60% increase today.
Was anyone following this stock today?
ABN AMRO has 12 month target price of $1.15 in an old report dated 17 June 2004 as posted on Alchemia's website at
http://www.alchemia.com.au/media/ABNAMROReport_17June2004.pdf
but now it looks a bit overvalued for a company with no cashflow... I suppose that's the nature of bubbly biotechs? Does anyone have any insight into ACL? I'm no biotech expert so I assumed I was going to take a long-term investment approach but the trade off is opportunity cost... IMHO, I think this is a company with great potential in a few years time but I would like to hear what others think!
All positive and negative opinions welcome:)
tommy
14-02-2005, 06:50 PM
Haven't been any interesting news from ACL of late, and understandably the share price is starting to fall due to impatience on the part of holders (now below 70c)... not worth holding on to this HIGH RISK stock for months consdering the opportunity costs in the current market, I suppose!
Having said that, I personally think this is a stock worth keeping an eye on to buy on the cheap if you like bubbly biotechs, especially if it hits below 60c, preferably in mid-50s. Hoping for a further price fall to reenter soon:)
Of note,ABN Amro still has price target of $1.15 accoridng to Dec 2004 report.
http://www.alchemia.com.au/media/ABNAMROReport_10Dec2004.pdf
Am I the only one interested in this lemon here? Your thoughts will be appreciated;)
tommy
01-04-2005, 01:19 PM
Damn,was waiting for ACL to drop to $0.55 to buy in again but bounced subsequent to following announcement yesterday...
____________
31 March 2005
ASX / MEDIA ANNOUNCEMENT
Alchemia awarded $7.8 million Australian Government GranAlchemia Grant
Australian biotechnology company Alchemia Limited (ASX: ACL) today announced it had been notified of its successful application for a $7.8 million research and development (R&D) grant under the Federal Government’s Pharmaceutical Partnerships Program (P3 Scheme).
The P3 grant entitles Alchemia to funding of up to approximately $7.8 million over three years starting from 1 July 2005 to support a number of its drug development
projects, dependent on the company meeting forecast R&D expenditure for the period.
Alchemia Chief Executive Officer Dr Tracie Ramsdale said the P3 grant was a major boost for the company, providing additional funding for the company’s planned R&D
activities for its advanced and early-stage drug discovery programs over the coming three years.
“This is the fourth Australian Government grant awarded to Alchemia since the company’s inception in 1995. We are enormously grateful for the strong support of the Australian Government and for the continued recognition of our promising drug development programs,” she said.
Alchemia drug development and commercialisation projects that are covered by the
P3 grant include:
Anti-cancer program — formal preclinical studies of Alchemia's novel angiogenesis inhibitor ACL 16907 required for an Investigational New Drug (IND) application planned by the end 2005 and subsequent Phase I/II clinical trials
Antibacterial program — optimisation of a series of novel antibacterial agents shown to be highly active against multi-drug resistant bacteria in vitro, establishing efficacy in suitable animal models of infection and formal preclinical
studies in order to start Phase I clinic l trials
Identification and evaluation of preclinical development candidates in other therapeutic areas arising from Alchemia’s VAST#63195; drug discovery platform
including Age-related Macular Degeneration (somatostatin agonists), Chronic pain (mu-opioids) and Obesity (melanocortins, MCH).
Alchemia was awarded the grant under the second round of the P3 scheme, under which $150 million has been provided on a competitive basis to companies undertaking pharmaceutical R&D activity in Australia.
ENQUIRIES: RELEASED BY:
Dr. Tracie Ramsdale Ms Josie Brophy
Alchemia Limited Phillips Group
Chief Executive Officer Tel: 61-7-3230-5000
Tel: 61-7-3340-0200
About Alchemia
Alchemia is a drug discovery company with a novel carbohydrate platform technology focused on the development of a generic Synthetic Heparin and on discovering a pipeline of oncology and antibiotic therapeutics. Alchemia has leveraged its carbohydrate chemistry expertise to develop a more efficient,
economical manufacturing process which Alchemia believes will ensure its generic Synthetic Heparin will be cost competitive with Arixtra® and other heparin-related drugs, providing Alchemia with a potentially significant market share of the
$US3 billion worldwide heparin market.
Alchemia’s generic synthetic heparin is being developed in collaboration with manufacturing partner, The Dow Chemical Company and marketing partner, American Pharmaceutical Partners and is expected to be launched in the US in 2008.
For further information on Alchemia’s drug discovery projects please refer to the company’s 2004/05 half yearly report available at www.alchemia.com.au
utedog
04-04-2005, 01:26 PM
I've been watching this one also tommy and was waiting for the drop from the highs of last year. I'm no expert but I like this one and what they are doing. Good value below 65c i think. Have a look at BDM also, they are cheap at the moment.
regards
utedog
tommy
04-04-2005, 02:44 PM
Hi Utedog,
I'm waiting to re-enter ACL below 60c, I think the opportunity will arise soon in the current climate considering this is an easily-battered stock when the bear is on the rise... cheers for info on BDM, will do some research on this too, looks interesting!
tommy
07-04-2005, 12:15 AM
Up 8.93% today, missed the boat to buy ACL in mid 50s:( but managed to buy more MAL instead in mid-50s so not complaining:D
tommy
31-05-2005, 01:16 PM
ACL up 8.33% after announcement, gee this biotech likes to go up and down like a yo-yo;)
____________
31 May 2005
ASX / MEDIA ANNOUNCEMENT
Alchemia’s Synthetic Heparin market potential boosted by additional FDAlchemia’s FDA approval for Arixtra
Australian drug development company Alchemia Limited (ASX: ACL) today announced its generic Synthetic Heparin drug had significantly increased market potential following recent approval by the United States Food and Drug Administration (FDA) to extend current applications of GlaxoSmithKline’s (GSK) branded synthetic heparin drug Arixtra.
Alchemia Managing Director Dr Tracie Ramsdale said the approval paved the way for Alchemia’s Synthetic Heparin product — a generic version of Arixtra® — to tap a more extensive heparin market when it was launched in 2008.
“GSK has flagged its intent to file for the additional approvals required for Arixtra® to obtain all heparin indications by the end of 2006, which highlights the excellent
commercial prospects of Alchemia’s Synthetic Heparin,” she said.
The recent additional indication — approval to use the drug in patients undergoing abdominal surgery — is one of two applications submitted to the FDA by GSK to increase Arixtra®’s coverage of the heparin market.
In February this year GSK was granted approval from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) in favour of extending the use of Arixtra® in preventing venous thromboembolic events in
medical patients who are judged to be at high risk of thromboembolic complications — the company’s second application currently before the FDA.
Alchemia’s Synthetic Heparin is currently progressing through the necessary scaleup and regulatory processes to enable its US marketing partner American Pharmaceutical Partners (APP) to file an abbreviated new drug application (ANDA) for Synthetic Heparin in 2006, shortly after the FDA clinical exclusivity period expires on Arixtra®.
The total market for heparin-related drugs in 2004 exceeded $US3.5 billion.
Dr Ramsdale said Alchemia expected its Synthetic Heparin to capture a significant portion of this growing market in a relatively short period of time.
“Historically, generic drugs have been proven to capture up to 90% of market share from their branded counterparts upon introduction to those markets,” she said.
“We anticipate our product will have significant cost advantages over Arixtra due to the improved manufacturing technology developed by Alchemia. We have the support of APP, who has considerable experience and success in selling generic
drugs to the US hospital market.”
The FDA approval to expand Arixtra®’s indication is based on the results of a recent study which demonstrated the drug was at least as effective as low molecular weight heparin (dalteparin) in reducing the risk of venous thromboembolism (VTE). In the study, 4.6% of patients receiving Arixtra® experienced a VTE incident compared to 6.1% of patients on dalteparin.
Arixtra® is already approved in Australia, the United States and Europe for the prevention of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients undergoing surgery for hip fracture, knee replacement and
hip replacement.
About Alchemia
Alchemia is a drug discovery company with a novel carbohydrate platform technology focused on the development of a generic Synthetic Heparin and on discovering a pipeline of oncology and antibiotic therapeutics. Alchemia has leveraged its carbohydrate chemistry expertise to develop a more efficient,
economical manufacturing process which Alchemia believes will ensure its generic Synthetic Heparin will be cost competitive with Arixtra® and other heparin-related drugs, providing Alchemia with a potentially significant market share of the $US3.5 billion worldwide heparin market.
Alchemia’s generic Synthetic Heparin is being developed in collaboration with manufacturing partner, The Dow Chemical Company and marketing partner, American Pharmaceutical Partner
tommy
15-09-2005, 09:29 PM
Ready to hit the $1 mark since the recent announcement of positive safety results from Arixtra trial (http://stocknessmonster.com/news-item?S=ACL&E=ASX&N=170444)
I had never expected ACL to bounce back more quickly than MAL :( (I was juggling between the two and opted for MAL(Damn!)[xx(]), good luck to holders and enjoy the ride[}:)]
http://asx.netquote.com.au/charts.asp?code=ACL
tommy
28-09-2005, 08:45 PM
Now AMP is a substantial holder
http://imagesignal.comsec.com.au/asxdata/20050928/pdf/00552111.pdf
tommy
30-09-2005, 03:26 PM
Annual report out:
http://stocknessmonster.com/news-item?S=ACL&E=ASX&N=171156
And announcement (pasted below):
http://stocknessmonster.com/news-item?S=ACL&E=ASX&N=171175
This IMHO significantly reduces the risk for ACL, I am watching this stock VERY CLOSELY.
http://asx.netquote.com.au/charts.asp?code=ACL
______________
30 September 2005
ASX / MEDIA ANNOUNCEMENT
Update on progress of Synthetic Heparin pilot scale manufacture
Australian drug development company Alchemia Limited (ASX: ACL) today updated the market on the status of the pilot scale manufacture of its generic anti-blood clot drug Synthetic Heparin.
The commercial cGMP scale up of 500-grams of Synthetic Heparin is nearing completion at the United States facilities of Alchemia's manufacturing partner The Dow Chemical Company (Dow), with over 95% of the steps having successfully
progressed through the pilot plant.
Alchemia Managing Director Tracie Ramsdale said the chemistry had translated very well, with excellent results achieved in terms of product yields and quality.
"Yields from this process have been at least as good, and in some cases better, than those achieved in the laboratory scale-up at Alchemia's Brisbane site, thanks to the expertise of our partners at Dow,” she said.
Alchemia targeted completion of the commercial scale-up campaign by the end of the September quarter. The process is now at the penultimate step which will enable Dow to evaluate two alternative purification processes for the final product.
Both of these processes are viable for commercial scale production and an evaluation and comparison will be undertaken over the next two weeks in order to select the best
option. Once that decision has been made the first batch of commercial material is expected to be out of the plant in October.
Dr Ramsdale said the development process to date had demonstrated Synthetic Heparin could be successfully scaled up from laboratory to pilot scale with consistent product quality.
“We are confident the completion of the pilot scale campaign will result in a robust, commercially viable production process,” she said.
“Successful completion of the pilot scale manufacture will represent the most important milestone to date for the Synthetic Heparin program, resulting in a significant reduction in the overall project risk.”
Dr Ramsdale said following completion of the pilot scale manufacture the regulatory and market launch costs of Synthetic Heparin would be the responsibility of
Alchemia's marketing partner American Pharmaceutical Partners (APP).
"After the scale up APP will undertake the formulation and stability process required to lodge an Abbreviated New Drug Application (ANDA). The ANDA will be filed with the FDA in December 2006, shortly after the FDA market exclusivity period expires on branded synthetic heparin drug Arixtra®," she said.
"The regulatory approval process for a generic drug is significantly shorter and less costly than that required for a new drug, enabling an anticipated 2008 market launch for our generic Synthetic Heparin.
"As the only known generic competition for Arixtra®, Alchemia will be well positioned to capture an attractive market share upon the launch of our product.
The total market for heparin-related drugs in 2004 exceeded $US3.5 billion."
The commercial scale-up campaign, based on the culmination of more than five years of internal R&D, commenced in February 2004 and involves the scale-up and optimisation of one of the most complex proprietary syntheses in the pharmaceutical
arena.
Arixtra® is currently approved in Australia, the United States and Europe for the prevention of venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients undergoing surgery for hip
fracture, knee replacement and hip replacement.
tommy
03-10-2005, 09:05 PM
ACL up 27%, sell side still thin. Looks like its overbought but doesn't seem to stop[:o)]
tommy
04-11-2005, 02:47 PM
Another piece of good news, despite capital raising at $1.10.
Lack of interest in ACL at this forum has been quite surprising, considering the massive gains over the past few months (I no longer hold but will get back in on any weakness!)
http://asx.netquote.com.au/charts.asp?code=acl&x=0&y=0
_________
http://stocknessmonster.com/news-item?S=ACL&E=ASX&N=172326
3 November 2005 ASX ANNOUNCEMENT
Alchemia granted US Patent for key carbohydrate building block technology Australian biotechnology company Alchemia Limited (ASX: ACL) today announced it had been granted a key patent by the US Patent and Trademark Office.
The patent, entitled “Protecting Groups for Carbohydrate Synthesis” (US 6,953,850) protects many of the building blocks used in the development of VAST™ discovery libraries, and provides a significant barrier to entry for others wishing to prepare similar compounds.
It covers the ability to use common intermediates to build desirable compounds in a rapid and cost effective manner, providing an advantage in the drug discovery process.
Alchemia Limited wholly owns this US patent, which expires on January 18th, 2020. The same patent had previously been granted in Australia (771,708), and is pending in other major jurisdictions including Europe, Japan, and China.
This information is reported in voluntary compliance with the ASX/AusBiotech Code of Best Practice for Reporting by Life Science Companies.
Christopher Neal Company Secretary
tommy
08-02-2006, 04:28 PM
Alchemia’s Synthetic Heparin successfully completes pilot scale campaign:
http://stocknessmonster.com/news-item?S=ACL&E=ASX&N=174427
Risks substantially lower now. Stock to watch!
tommy
27-02-2006, 04:34 PM
ACL creeping up again too, bouncing back from capital raising at $1.10.
Reports six months of solid achievement
http://stocknessmonster.com/news-item?S=ACL&E=ASX&N=174792
Half Yearly Report & Half Year Accounts to 31 Dec 2005
http://stocknessmonster.com/news-item?S=ACL&E=ASX&N=174793
Chart:
http://asx.netquote.com.au/charts.asp?code=acl&x=0&y=0
gambier33
20-01-2008, 12:46 PM
Hi Tommy
Do you still follow this stock? I still have my holding - I purchased it for my SMSF as the 1% high risk component I'm comfortable with (all the rest a blue chip) and have been happy to sit on it. This year is meant to be the big one for the herapin product but the steady fall in ACL over the last few months has surprised me.
Regards
anyone still in ACL? it's had a strong run of late, but still at basement prices. ANDA submitted to FDA and should be given the green light in six months. cash on hand is enough to see it through to first revenues and there is no problem with debt. it has a very good producer/distributor partner in Dr Reddy and looks ripe for great things. it's lead compound Fondaparinux will only compete with one other drug, which brought in $315m in sales in 2008 (and have been steadily increasing each year, and are predicted to continue to do so). ACL market cap is just $40m so a small percentage of the market share will have a massive impact on the sp. moreover, it's oncology drug currently in stage II trials looks very promising. this looks like a gift. jdg is in.
-j
floyd
26-03-2009, 11:12 AM
yeah im in, was lucky enough to pick all my shares up at 12.5c... next 6 months should be interesting waiting for the green light to be givem from the fda
great! i thought i might have to be speaking to myself. pleased to have at least someone else keeping an eye on this one.
i think the next 12 months will be interesting. if the FDA maintain their policy of getting first generics approved within six months, we should see Fondaparinux launched in the fourth quarter. that will means a big re-rating of the sp. on average first generic gains 40% market share. even though we are only open to the US market (until 2012, when Europe opens up), that is big revenues for ACL. if US sales for Arixtra (the existing synthetic drug) are around $200m pa that should mean $80m pa for Fondaparinux, of which ACL get at least half and up to 60%. current market cap is $40m.
moreover, other competition is unlikely, and even if it occurs is some time away. also, the market share of Arixtra is ever increasing as it's safety and efficacy are greater than the 'naturally' derived alternative. this looks as though it will be a massive cash cow.
added to all this is the other technologies the company is developing. the pipeline looks great.
-j
in my only bit of TA knowledge (thank you , Phaedrus) i notice a double top has appeared. a bearish sign i am reliably informed. it will be interesting to see where she goes from here. i'm looking to buy a few more on any pullback. the FDA make an initial assessment on the ANDA after about 45 days, so that's later this month. the sp will go very quickly in either direction on positive or negative news. i'm backing that it will be positive given the time the application has taken (read care in getting it right) and the fact the Dr Reddy has huge experience in this area. this is a risky play, but i very much like the odds.
-j
ahem, i have just been told on another forum that it is in fact not a double top. my one foray into TA and i show a pair of twos!
right, best i stick to talking about what i know best, which means i should stay right away from anything to do with technical analysis, golf, or marriage.
as you were.
-j
ACL is still on the the rise. currently up 13% today to 34c. the FDA should give its initial assesment before the month is out. if all goes well, that should put a rocket under the sp. this is a high risk play, but with that comes the big rewards. i'm feeling very good about this one.
-j
STRAT
15-04-2009, 08:03 PM
ACL is still on the the rise. currently up 13% today to 34c. the FDA should give its initial assesment before the month is out. if all goes well, that should put a rocket under the sp. this is a high risk play, but with that comes the big rewards. i'm feeling very good about this one.
-jAaah, the good ol FDA. Like waiting for moss to grow, that lot. :D and not remotely biased :rolleyes:
yeah, strat, i'm hearing you. what gives me greater confidence in this instance is the fact that Dr Reddy is doing the paper work and that company has such vast experience in this area. their proven track record gives me confidence.
also, the ANDA took an age to compile, and from this i take they really made sure it was spot on. one broker report, however, did say that the FDA are experiencing delays currently, but a few weeks either way is of little consequence so long as we get GIVE status - meaning a target sign off of six months.
don't get me wrong, there are still a few fish hooks along the way and many things could trip us up, but if this goes to plan and Fondaparinux is launched at the end of the year (or even the beginning of next), this thing will sale north like a rocket ship.
moreover, there is the ongoing possibility to get a deal surrounding ha-irinotecan to conduct stage III trials - that would give even greater fuel to the ACL rocket...!
but first we'll see if the sp can maintain it's momentum from yesterday.
-j
this baby just keeps on heading north. up another 6 percent to .435c on a very down day. this stock is going places and it's waiting for no one. floyd, you've got to be smiling, but i'm surprised no other members here are in. i'll just keep on talking to myself...
-j
STRAT
21-04-2009, 01:54 PM
this baby just keeps on heading north. up another 6 percent to .435c on a very down day. this stock is going places and it's waiting for no one. floyd, you've got to be smiling, but i'm surprised no other members here are in. i'll just keep on talking to myself...
-jHi J,
It sure is going strong. I was tempted but think I missed it. Its a bit frightening trying to jump on a fast moving train :eek:
Volume is slowing and I still have the scares from being wounded by biotechs in the past lol
i've got my share of battle scars too. i took a hammering on AVX that i won't forget in a while, but ACL is so well set with a great production/marketing partner, a good chance of product launch at the end of this year (though more likely the beginning of next, i suspect), and a promising oncology treatment ready for stage III trials.
first news out of FDA is due some time around the end of this month. if that is positive then this ride will continue long and hard. but as we both know, mate, with biotechs, there remains a high degree of risk. but with that risk comes reward.
i hope you're making heaps on your investments, Strat, but i also hope you look back on ACL at 40 odd cents and think, 'damn, that was cheap!' (and draw a graph with a smiling jdg lighting cigars with 100 dollar bills).
-j
floyd
21-04-2009, 04:52 PM
still smiling jdg.... hope that news from the fda is positive
me too - on both counts.
-j
a pullback was perhaps inevitable, but the rush to sell a few minutes ago (on pretty modest volumes) surprised me. i couldn't resist the temptation to pick up a few more at 33 cents. that's now my fill. from here on i'm happy to sit back and see what cards the FDA deals me.
-j
ACL is bouncing back strongly today. currently up 19% to 38 cents. a post on another forum put this rise into perspective, though, by looking back at the ACL IPO in 2003. i hope dannylee won't mind me posting it below:
[STARTS]
it's the fundamentals
Alchemia's market cap at $70 million, with 160 million shares at 43.5c, is back to what it was at IPO at the end of 2003, when there were 100 million shares at 70c.
What's changed in the last five and a half years?
Fondaparinux market launch is maybe a year and a half behind schedule, but is now due in six to twelve months instead of four to five years -- and with commercial scale production achieved and the drug application filed, a lot of the risks have gone.
At IPO Arixtra sales were only $10 million per year, so the prediction of $360 million sales in 2008 was quite speculative -- but it has turned out to be only slightly overoptimistic. A huge uncertainty here has been resolved.
And along the way Alchemia has picked up the entire HyACT cancer drug development pipeline, with the lead candidate now in Phase III trials.
Of course the investment climate was very different in 2003, and it's arguable that Alchemia was overvalued at IPO. But it's still easy enough to generate company valuations around $500 million without making any extraordinary assumptions.
[ENDS]
$500m seems a bit excessive to me at the moment, and we’d need a licensing agreement for HyAct to get near it - although i've seen valuations from a couple of years ago that agree with him. but i certainly concur that a current market cap of less than $60m seems like bargain (if all goes to plan).
i believe the FDA will give its initial assessment of the ANDA between 45 and 60 days. the filing was announced on March 13, so there should be news due some time between now and a couple of weeks. while i expect the stock to leap on any positive news (and, of course, reverse if the news is bad), there may well be a few traders who are buying the rumour and will sell on the news. either way, i'm unconcerned. if the FDA gives this its initial tick, we are on path for revenues to begin late this year or early next. yip, we'll take a good chunk of Arixtra sales - probably around 40+% of the $200m in US sales - but if we can get even a smidgen - just a slither - of the billions of dollars of Lovenox sales...well, you'll hear jdg laughing from wherever you are in the country. once again, i’d be pleased to hear from anyone who’s having a look at ACL. it could well be that i’ve got all of this horribly wrong – it’s happened before.
-j
gambier33
02-05-2009, 06:50 PM
I've stuck with ACL since the float and through the long and slow price slide. I have continued to pick up stock when I had the spare cash. I'm a buy and hold sort of person and I have a lot of faith in Alchemia to deliver! On Aussie Stocks Forum I have recently posted my interpretation of what I think the "Investor Presentation" ACL released on 17 March 2009 means in terms of future free cash flows and EPS for ACL when FDA approval to sell fondaparinux comes through. I'll revise it and post it here soon given there's probably more life in this Sharetrader ACL discussion than on the former.
I notice that in the last week or so the share price and daily volume has tended to ease. This doesn't surprise me at all and it certainly doesn't diminish my enthusiasm for the stock. To the contrary, I'll buy more on retreats. A stock like this needs news to create jumps in interest. ACL also have around only 166 million shares on issue and I suspect here are a few diehards out there like me who have bought and held. So the liquid portion is probably quite small.
A successful ANDA has to have an enormous impact on ACL's share price. The daily sales volume should increase significantly and with that so should the price. I believe the cash flows then will support a share price around $2. With a successful product in the market place you'd have to think ACL would be put into takeover territory.
hey gambier33, i'd be very keen to hear your thoughts. i look forward to your next post.
-j
gambier33
03-05-2009, 06:31 PM
Hello jdg, here's my analysis using only the information in Alchemia's 17 March Investor Presentation which was released to the market. As Alchemia is Australian based (as I am) I have ultimately converted USD infromation to AUD:
1. It is estimated that the Innovator drug, GSK's Arixtra, will have USD250 to $300 Million sales in CY 2009.
2. The first generic (e.g. ACL's Fondaparinux) typically gets 40 to 50% of market at a 20% discount.
3. Using USD250M and 40% of market and applying the 20% discount gives Fondaparinux sale revenue of US $80 mill to divide between Alchemia and Dr Reddy's.
4. Alchemia's share of profit is expected to be between 30% and 35% of generic sales which, if you take 30%, equates to US $24 million = Aus $34million (0.70 exchange rate).
All based on the conservative figure of the ranges given.
5. The number of shares and options on issue - 166 million.
6. Therefore potential annual earnings per share = 34/166 = 20.5 cents (AUS) per share based on this conservative case scenario.
7. That 20.5 cents is pretty much without any "cost-of-sales" (almost all profit to ACL) as that is incurred by Dr Reddy's.
8. Using a middle of the road scenario, which is probably more realistic, the annual EPS from Fondaparinux would be 27.7 cents
The risks:
1. FDA knocks back the ANDA (why did APP pull out to be replaced by Dr Reddy - investors don't really know).
2. FDA delays the OK. ACL have taken their cash burn pretty much to the brink and need cash inflow by the end of this year to avoid raising more - not a good market to be doing that!
3. Another generic could enter the competition - however, ACL seem to think that's unlikely due to the synthesis complexity and their patent protection.
Upside:
1. Sales for low molecular weight synthetic heparin (GSK's Arixtra) are increasing all the time. 2010 sales will be better than 2009s.
2. ACL has other blue sky IP in the pipeline
3. Cash from Fondaparinux sales will give them huge cash resources to further exploit their VAST system.
If there is a "pay day" for investment in Alchemia, it's probably not far off. They could end up one of those rare biotechs that pays dividends to shareholders!
cheers, gambier33, it certainly is a good looking story. i'm a bit busy to reply more thoroughly, but i have one quick query and one point to add.
the question is: are you sure ACL doesn't contribute to the costs of manufacture? i'd be a bit surprised by that. i do remember seeing in one of ACL's presentations that Dr Reddy was paying costs - but i assumed that was the costs associated with the FDA submissions etc.
the point i would add is this: while it appears likely ACL will capture the percentage of Arixtra (based on similar scenarios and averages), there is the much bigger market to consider - that being non-synthetic heparin market dominated by Lovenox. most commentators were expecting Arixtra to take much, much more of the market off Lovenox than they have - given it has proven to be safer (and, i think, a once vs. twice daily treatment). that market exists for ACL's drug and if Dr Reddy can take greater bites into it then the sky's the limit.
also, it looks like the market is currently waiting for the FDA to give its initial review. ACL turnover has dried right up. shouldn’t have to wait too long. fingers crossed the news is good…
cheers, mate.
-j
well, we got the news we were wanting for; one more risk removed. a couple of posts ago i raised the possibility that some people may sell the news, and that looks to have been the case - it only had a modest rise on much higher than normal turnover. today's trading will be interesting.
-j
gambier33
12-05-2009, 08:27 PM
jdg, I think we are both right.
The arrangement with Dr Reddy is that the profit is shared equally (50%). This is mentioned in the CEO's presentation to the AGM on 21 Nov 2008. So you are right when you recall that ACL contributes to the manufacturing costs. Under certain conditions (I think it is connected to the total revenues for Arixtra in the year Fondaparinux is released to the market) ACL's share of profit can be as high as 60%.
In the 17 Mar 2009 Investor Presentation, ACL advise that their share of profit will be between 30% and 35% of sales. So I read that as 30% of sales equates to 50% of profit. The balance must be the cost of sales manufacturing and marketing. During the 2007 AGM (23 Nov) the CEO said in her address that the cost of manufacture had exceeded ACL's most optimistic forecasts and that would feed through to greater profits for Alchemia. I used the 30 to 35% figure in my analysis, so it still holds true.
I tried to be conservative in my analysis. I agree, however, that there is a lot of upside as Lovenox gets displaced more and more by the synthetic, Arixtra. Its market share is certainly climbing and events like the reported contamination in animal derived heparin last year must have been good for Atrixtra sales and would continue to be so (as Alchemia said in a release at the time).
The news yesterday of the acceptance of the ANDA by the FDA was certainly positive with another of the risks (a minor one) removed. I believe the FDA can be ruthless if the documentation submitted doesn't meet their high standards. ACL are still on their timeline.
The price movement today was better (I think you were expecting that jdg), as investors had digested the good news, though I expect price and volume will wane again until the next announcement and the final ANDA tick comes through. cheers
hey gambier, i was wondering what had happened to you - i didn't realise you had replied until i looked just now.
yeah, i was expecting the sp to firm a bit the day after the announcement - it did that but, as you predicted, the price has since drifted. i must admit i thought it would run on official ANDA filing. given it hasn't, i tend to agree that it will continue to drift or gently track up until we hear from the FDA. the wildcard, though, is an announcement regarding the HyAct technology and more specifically stage three trials for ha-irinotecan. a partnership there would put ACL into orbit i'm picking.
thanks for sharing your research and opinions, i appreciate them. ACL has treated me well and if all goes to plan i believe it has got a lot more giving left.
-j
gambier33
16-05-2009, 02:31 PM
jdg,
I can be slow to reply as I don't have the time to contribute regularly, but I'll check out Sharetrader once or twice a week. For stocks I follow I like to see what others have gleaned and reported. The quid pro quo of that is, of course, to put ones own thoughts into the melting pot. By posting I am not wanting to "convert" someone to the stock I mention, but am hoping the feedback helps me improve my understanding of the company and make better informed investment decisions. For example, your comment on my ACL post made me take the time to make sure I understood the profit share mechanism between ACL and Dr Reddys. I didn't have it clear in my head but do now. It has a very direct bearing on the current value of ACL.
So far I have focused exclusively on the Fondaparinux side of Alchemia. You have now given me the heads up that some of the HyAct stuff is advanced enough for Phase III trails. I'll look more closely. I agree that that the right partnership announcement would give ACL's sp a good jog along. These partnerships with the majors often come with annual licence fees, even in the early days, lump sums on milestones, such as successful completion of P3 trials, and then regular royalties on commercialisation. Given irinotecan is either off patent or about to be, I did think that the original owner of its IP would be the ideal partner - surely it's a way for them to extend the exclusivity of their compound. I guess negotiation of partnerships is all about what a company like ACL wants in return for giving access to IP to the other party. If you have terminal cash burn you'll roll over at a lower price. I suspect that ACL is better waiting until they have the royalty income from Fondaparinux coming in and then negotiating without the cash burn gun held to their head.
hey Gambier, your thoughts on the forum mirror mine.
longer term the HyAct technology has the potential to be worth much, much more than generic Fondaparinux (if it can fulfil the potential it has shown thus far). currently the market has ignored it because the cost of the trial - about $20m - means it's been put on the backburner as ACL has cut costs to avoid capital raisings. current reserves should be sufficient to see us through to revenues - at which point, if no partnership has been entered into, we'll run the stage three trial.
although self funding the trial would allow ACL to keep a greater percentage of future commercialisation profits, i'd prefer they gave up some of this by gaining a partnership asap. firstly, the quicker we get started the quicker we get to the finish line. secondly, if a large pharma pays for the costs then that's money we don't risk. thirdly, if a drug was to be commercialised that countered colon cancer there would be more than enough profit to share. from memory irinotecan earns $300m+ per annum (but my memory's not flash, i'll check and get back to you on that.) moreover, that's only one application... it has the potential to be massive.
i wonder if they've been in talks with Dr Reddy?
-j
hey gambier, i just had a look for Camptosar (branded irintecan) sales and found they were US$556m in the US alone for the 12 months ended 2007 (best figures i could find on my quick search). it's off patent now, but that offers some indication of the potential of an improved form of irintecan (using HyAct technology). i note that ACL say in their last presentation that they are targeting CY09 for phase III trials, so let's hope they have something up their sleeve that would get this oncology arm of the company really moving.
-j
a nice rise yesterday on good volume and it's holding its own so far today. this stock has become like a jack in the box - each day is a turn of the crank and it's unclear when the next bit of news will jump out.
-j
i've been travelling around europe for the past few weeks and haven't been keeping much of an eye on the markets (yip, that was largely just an excuse to boast), but i am very pleased to see ACL spiking up. with the possibility of FDA approval in the near future this one has the potential to really take off (all reliant on good news, of course). floyd, gambier, you both still in this one?
-j
gambier33
29-08-2009, 06:41 PM
Hi jdg
Definitely still in. Have a portfolio dangerously skewed to ACL but, even then, most of my thoughts are on averaging up rather than taking any profits now. "Buy on the rumour, sell on the fact."
Daily share trade volume has also been on the up with the rising price. I reckon there's some stake building going on in anticipation of FDA approval of Fondaparinux.
I understand that once sales of fondaparinux start, it will be around 3 quarters before first royalty/licence money is received by ACL. Due to that delay in actual cash inflow, I reckon that after FDA approval the share price will ease from its announcement high until ACL are close to receiving payments from Dr Reddy. Should then climb again. My SP pick is then about $1.80, but hoping for $2.00!
hey gambier, the sp dropped back a bit after the pre- final report dampened speculation that the FDA may give word shortly. it sounded to me like late this year or early next - but who knows. either way, the sp has firmed in recent days. it will be interesting to read their presentation notes to the rodman and renshaw conference. the great news from the announcement was that only one stage three trial is needed for HA Irinotecan. that's only $20m - and could well prove to be the best $20m ever spent... it really does look a good one.
-j
a nice wee rise in the last week and the sell side is incredibly thin. we may see the sp continue to go up. still, it's all a bit academic at the moment. the FDA will determine the story's end. i noticed in the last presentation that ACL was still forecasting a decision by year's end. let's hope that decision is both timely and positive.
-j
gambier33
26-09-2009, 05:20 PM
How's it going J? This little investment just keeps on going to plan. Closed on ASX at 57.5 cents on Friday 25/9/09 but has been at 60 cents in recent times.
ACL have now indicated twice that they hope for FDA approval this year. They also supported that with the way ongoing communication with the FDA on the ANDA is going.
I keep pinching myself on this one - is it too good to be true? I reckon $1 (AUD) in the New Year. Cheers
yeah, it's looking pretty good, gambier. i'm not too sure what to make of GSK and Dr Reddy looking to position themselves closer (in whatever way transpires). I don't much like our partner and our competitor getting into bed.
nevertheless, i think ACL will certainly be around the $1 mark if/when we get FDA approval.
initial net profit should be at least $30m and that's without europe, which opens up in 2012. what's more, we have the HyAct technology ready to be tested by stage three trials next year, and that should spark more interest in the company. i still think ACL is very cheap.
things are looking good, but let's hope that the FDA doesn't spoil the party...
-j
it seems to be a bit of a stand off in recent times. perhaps we'll have to wait for the FDA announcement to get some real movement now.
in an email Pete Smith (who, to his credit, is really good with investor questions) told me that the FDA doesn't provide data on the average time from submission to decision but he said that they (the FDA) are struggling to meet their six month timeframe. he estimated that 8-9 months is realistic and so ACL are giving them a bit more breathing room and saying 'end of year', which is ten months.
these delays are costing us a great deal of money (and frustrating investors). still, i'll be more than happy if we hear in the next couple of months and the decision is in the affirmative.
i was also pleased to note on another forum (thanks TDA) that GSK are conducting a large trial with Arixtra - obviously more applications would be brilliant for ACL.
-j
"these delays are costing us a great deal of money"
Hows that?
I don't understand investors logic on this stock, everyone keeps going on about its value post FDA, and seem assured it will get that FDA.
If so why not take advantage of this stand off and accumulate at what could be half the ACL's SP come Xmas?
Or wait for a/the correction where nothing at all would have changed Re FDA process, and not enough depth for any accurate TA - but ACL could all of a sudden be up for grabs in the 40-50c range..
Summary - I'm bullish on ACL, but am taking advantage of this delay and accumulating.
"these delays are costing us a great deal of money"
Hows that?
perhaps i didn't make myself clear. the company would be making money if we had eariler approval - hence the 'cost' to the company.
i have filled my boots with ACL, but that doesn't mean i can't lament delays by the FDA.
-j
gambier33
24-10-2009, 11:42 AM
Hi buns, nice to find another person interested in this stock.
I see it much as jde does and lament any delay by the FDA. It's a cliche, but as well as its cash value, "money" also has a time cost. A dollar today is worth more than a dollar in 6 months time.
Until Dr Reddy and ACL get FDA approval for Fondaparinux, and sales revenue coming in, ACL is still on a cash burn pathway. I noticed in yesterday's 4C announcement they are down to the last $6.7 million. It costs them around $1.5 million per Q to operate, even after their downsize a year or so ago. The quicker they get the revenue stream the better.
Like jdg I've also "filled my boots" with ACL. I've significantly topped up in the last year so that now I'm to close to my "can-sleep-at-night-without worrying" level . However, it's a risk/reward situation, and even though my heart is very optimistic about a company making FDA decision, my head tells me that it's not guaranteed until the fat lady sings.
gambier I should thank you for first as this thread is what opened my eyes to ACL. Since then I've gone on and researched this puppy and jumped on board. Ha I'm hoping it's still a thank you come Dec/Jan...
I suppose I'm in the other boat. I still have a little room in my boots and enjoy topping up every now and then from weekly earnings. I’m not sure which party you are talking about Re ‘time value of money’, if its yourself I’m assuming you are in ACL short, if you mean the company itself I don’t think a few months delayed earnings will mean to much to the SP once they finally get approved. As its anyone’s guess to what that SP could go to..
Up 9c.....
the big news or reactions to reports/articles?
gambier33
26-10-2009, 06:11 PM
Hi buns, ACL hasn't been a big reactor to reports or articles in the past. Volume of 1.2 million today is very unusual (large). On the ASX they got up to a peak of AU $0.64 during the day but look like closing at $0.585, still up by 8.33% from Friday's price. Might trigger an ASX speeding ticket, but the answers to those never seem to explain much!
Inside knowledge or a bigger than the usual two-bit player (a major pharma?) starting to build a stake? Now's the time for both to make their move. Might be an interesting week. I wish I had the play-money to buy more!
COLIN
26-10-2009, 10:21 PM
I have read somewhere in the last day or two that there is some important conference in Australia this week, at which important biotech investors from the US will be present. The article also mentioned that Australian biotech companies in the development stages are selling for only about a third of similar companies on the Nasdaq, on a comparable basis, hence there is likely to be heightened interest in what Australia has to offer, particularly those that are at Phase III stages.
Perhaps this is why ACL jumped today? Also OBJ? And BTA, which is the only one I hold in this field - so far!
nice pick with BTA, Colin, there's been a bundle to be made on that one.
for today, i'll be pleased to see ACL hold over 60c. the volumes are encouraging in the last few days.
it's good to see a bit more interest in this one on sharetrader too. gambier and i have been by ourselves for a while now. it should make for bigger celebration when we hit $1…
-j
COLIN
28-10-2009, 03:53 PM
nice pick with BTA, Colin, there's been a bundle to be made on that one.
for today, i'll be pleased to see ACL hold over 60c. the volumes are encouraging in the last few days.
it's good to see a bit more interest in this one on sharetrader too. gambier and i have been by ourselves for a while now. it should make for bigger celebration when we hit $1…
-j
Tossed up between ACL and ACR, and ACR won. This whole biotech/pharmaceutical area is not one that I have much knowledge of, but having seen a few encouraging reports lately, I'm prepared to put a bit of the "high risk" portion of my portfolio in that direction.
selfishly, colin, i hope you made the wrong choice... but let's hope they both run in the right direction. best of luck.
i was very pleased to see ACL hold above 60c. it has been above that in intra-day trade a few times recently, so it's nice to settle there. even better to see increasing interest ahead of the FDA decision.
-j
COLIN
28-10-2009, 11:28 PM
selfishly, colin, i hope you made the wrong choice... but let's hope they both run in the right direction. best of luck.
i was very pleased to see ACL hold above 60c. it has been above that in intra-day trade a few times recently, so it's nice to settle there. even better to see increasing interest ahead of the FDA decision.
-j
Some good news, jdg: I am fast becoming a biotech junkie and today purchased some ACL - as well as some CXS. So, I now have ACL, ACR, BTA, and CXS. Trouble is that by trying to spread my risk in this manner I am probably spreading myself too thinly, but I am a "belt and braces" sort of fellow. May become a bit bolder as my confidence develops with these types of businesses.
i'm up to my eyeballs in ACL and CXS so you'll have my company in the times ahead. both have short timeframes to show their hands, so we'll soon know whether to toast our genius or curse our gross misfortune...
i'm pretty comfortable holding both at the moment, particularly ACL as it carries the least risk. as i've noted on the CXS thread, i want them partnered by year's end - then i'll relax a little more. the potential upside to CXS is perhaps higher than ACL, however.
one thing is certain: it's not going to be a dull ride on either.
-j
yogi-in-oz
29-10-2009, 11:33 AM
:)
Hi folks,
ACL ..... expecting November 2009 to be a choppy month for
the share price, as per time cycles ahead:
05-06112009 ..... negative spotlight on ACL to bring negative news
16-18112009 ..... positive cycle in play for a couple of days
19112009 ..... negativity returns ... finance-related ???
24-25112009 ..... positive news expected here
04-07122009 ..... positive light on ACL ... :)
11-14122009 ..... positive move expected ... finance-related ?
..... more later.
have a great day
paul
:)
=====
whoa, even the heavens are now taking note of ACL...
i'm not a believer, Paul, but thanks so much for your input (and i look forward to more). if nothing else, you've given me something to keep an eye on while waiting on the FDA.
cheers, yogi, and good luck with it.
-j
ACL is a green buoy in a sea of red today. it would be nice to see it hold onto its gains.
-j
i'd be surprised if we don't see a speeding ticket shortly...
floyd
01-11-2009, 04:17 PM
i was wondering if we would see a speeding ticket as well jdg, surprised there has'nt been one already. now if only that fda approval would show its head........ there would be no need
hey floyd, it has been a while. i wondered if you were still on board. hasn't it been a nice little run? much more to come if/when the FDA give us the nod. but i'd be very surprised if we don't have a reasonable sized pullback tomorrow. i think it's going to be one of those days.
good to hear from ya.
-j
:)
Hi folks,
ACL ..... expecting November 2009 to be a choppy month for
the share price, as per time cycles ahead:
05-06112009 ..... negative spotlight on ACL to bring negative news
16-18112009 ..... positive cycle in play for a couple of days
19112009 ..... negativity returns ... finance-related ???
24-25112009 ..... positive news expected here
04-07122009 ..... positive light on ACL ... :)
11-14122009 ..... positive move expected ... finance-related ?
..... more later.
have a great day
paul
:)
=====
not too much negativity on the 5th and 6th, yogi, but the 16th has started positively...
we have just passed the 8 month mark since submission, remembering that the guideline for ANDA priority review under the GIVE initiative is six months. we can't be too far away now...
-j
well, yogi, so far the stars haven't treated us too well. maybe we need to try the large hadron collider...?
however, all will be forgiven if we get the promised positive news today/tomorrow.
i hope all is well with you. and just as much i hope all is well with our ANDA application.
-j
floyd
24-11-2009, 10:53 AM
surely the fda decision cannot be too far away, one thing with biotechs ... you certainly learn patience
surely the fda decision cannot be too far away, one thing with biotechs ... you certainly learn patience
isn't that the truth. i know buns is happily accumulating - and good on him -, but i really would like to get this show on the road. not least so we can advance HyAct stage three trials.
here's some text of an email from pete smith, i mentioned a few posts back. it was received in early october:
The clock starts from the time of filing but,
in reality, the FDA is struggling to meet its six month objectives. The
FDA itself does not have any published data on its performance regarding
time to first review (we've asked for this) and, from what we can tell,
8-9 months appears to be more realistic - hence our 'by the end of the
year' prediction which would be 10 months from filing by the end of Dec,
so hopefully will prove to be a prudent forecast. Hopefully the FDA will
do better than that and any review and ultimate approval could be
sooner, but it is entirely out of our hands. Fingers crossed!
Best regards
Pete
technically, it's not ten months by the end of december - but it's close.
-j
floyd
24-11-2009, 12:06 PM
cheers for that jdg...
a rights issue...? i didn't see that coming. i'm happy to take them up. it's good to see them wanting to get the Hyact trial up and running. it certainly ramps up the gamble on getting a positive nod from the FDA.
-j
one point of significance out of the rights issue document is the fact they are going to attempt to produce an oral application of generic fondaparinux. that would be a fantastic breakthrough.
-j
COLIN
25-11-2009, 03:07 PM
a rights issue...? i didn't see that coming. i'm happy to take them up. it's good to see them wanting to get the Hyact trial up and running. it certainly ramps up the gamble on getting a positive nod from the FDA.
-j
Intend to take up mine, too. Its a bit annoying with these Aussy issues, though, that there is often a very short time between despatch of the offer documents and the closing date of the issue (in this case, between 9 and 23 December - when the mails are clogged and delayed with Christmas material). I use BPay but you still need the distinctive number on the relative application form.
My, the Chairman is positively ecstatic about the Company's future!
My, the Chairman is positively ecstatic about the Company's future!
agreed, i thought both his and Pete Smith's presentations were really encouraging. it really does look good as we move forward.
-j
with thanks to TDA
http://www.biotechnologynews.net/storyview.asp?storyid=1039257§ionsource=s0
HyAct really does have the potential to be a massive earner for ACL. if the stage three trial results come up trumps, it will dwarf generic fondaparinux.
-j
COLIN
04-12-2009, 04:31 PM
Its encouraging to see the keen interest in the rights, with very few sellers.
i was hoping to see approval before the rights were due. a few sold for 20 cents, which must be a bit painful for the buyers...
still, i've taken mine and have faith that, in their own good time, the FDA will come to the party.
nevertheless, given i have now invested more that i ideally wanted, the stakes of the gamble have become higher. i'm now quite sure i disagree with Oscar Wilde when he said, 'the suspense is terrible, i hope it lasts'.
he got the first part right, at least.
having lost faith in a satirist, i'm now pinning my hopes to a fat man in a red suit. if there's still no word in two days, i'm not ruling out a trip to the mall to have a word in his ear.
-j
COLIN
21-12-2009, 11:59 PM
i was hoping to see approval before the rights were due. a few sold for 20 cents, which must be a bit painful for the buyers...
still, i've taken mine and have faith that, in their own good time, the FDA will come to the party.
nevertheless, given i have now invested more that i ideally wanted, the stakes of the gamble have become higher. i'm now quite sure i disagree with Oscar Wilde when he said, 'the suspense is terrible, i hope it lasts'.
he got the first part right, at least.
having lost faith in a satirist, i'm now pinning my hopes to a fat man in a red suit. if there's still no word in two days, i'm not ruling out a trip to the mall to have a word in his ear.
-j
jdg: I take it that you have not subscribed for any "top-ups"? I haven't, either, but there is probably a bit of pocket money to be made in the short term there.
hey Colin,
i didn't apply for any top ups. a combination on no more available funds, and the fact that i think the chance of top ups being available is very slim. i can't see too many people letting the rights lapse given the 8 cent (15%) premium on offer. just imagine what it would have been if the FDA had come back during the offer period? it would have been pocket money for very big pockets... we still have a few days left in the year - let's hope the FDA come to the new year's party.
-j
well, Colin, there were a few tops ups. still, 19c for free on every share is not a bad result. i'm pleased the price has held up well and nobody is flicking them on for a quick buck. the extra shares on issue may mean a bit of selling after the fact, regarding the nod from the FDA, but i’m still expecting a great rise on that news (if there are no problems, of course). I must say that the length of time in making a decision is making me just a little jumpy.
-j
hey colin, i saw your note on CXS. the little rise keeps going for ACL. i'm a little surprised given i thought it would be stalemate before we hear from the FDA. still, if the news comes in (and in our favour) those buying today should be handsomely rewarded. anyone else still in this, floyd, gambier, buns, anyone?
-j
that 'little rise' is getting bigger and bigger. now at .78, which is a 12 month high. can it really break out from here? sell side certainly isn't stacked. let's see...
-j
COLIN
14-01-2010, 02:52 PM
that 'little rise' is getting bigger and bigger. now at .78, which is a 12 month high. can it really break out from here? sell side certainly is stacked. let's see...
-j
Exciting, eh! I think I need one of Dr. Reddy's Pink Pills for Pale People!
Oh I'm hoping that purchase that saw us hit 78 was the mail man or someone seeing the FDA approval letter..
Pete said within 2009! It has to be so close now...
gambier33
14-01-2010, 08:43 PM
hi jdg (and COLIN, buns and others for that matter). Yep, I'm still in ACL. I've always been in for the long haul. As a BTC holder, I got my first lot in the IPO float. Not to healthy on that lot but have purchased some much large tranches last year at 18 cents each, so weighed avg is good. Might review what I hold when $2 is hit.
Still a few nagging doubts but this is a glory or bust one for me so i'll hang in. FDA ain't a rubber stamp - they might knock them back. Stupid if we don't always entertain that possibilty. Other thing that troubles me is the research project ACL announced on looking at an oral form vs current injectible form. Why? I know most would prefer anything but an injection, but if its the only option you just have to lump it. Is there an oral heparin competitor on the way?
hey gambier, good to hear from you.
yip, there is an oral heparin on the way. from memory - don't quote me - it's in stage III trials so still a wee way away. also, i believe that oral and injectable are slightly different markets, for reasons that escape me (i'll look up the details over the weekend, if i get a chance). but one is that just before an operation until just after, oral is no good (empty stomach, unconscious etc). however, if we have both we should considerably expand our market. i think it's a tremendous development.
a prudent reminder also that FDA approval is no given. it's a high stakes game alright...that's what makes it fun - and hopefully very rewarding. i hope you have the drinks cabinet well stocked for the decision. either way we'll need it.
-j
floyd
15-01-2010, 12:05 PM
nice start to the day sofar.... some king of response from the fda must be close
good to see you still on board, floyd. you got into this before i did. it's been a long wait, but hopefully we can't be too far away. it's been a funny old run in the last couple of days. i hope those buyers know something we don't.
-j
gambier33
15-01-2010, 03:05 PM
I see ACL have touched 80 cents Aus on ASX today. Hearsay (HotCopper) is that there is broker coverage in Aus (RBS Morgan) and they have recently upgraded target price again to 98 cents and 90% for FDA approval odds. I assume they could be pricing it like an option to some extent (Black-Scholes model) and as the odds of FDA approval increase the traget price is increased as well. Haven't seen the report personally though and cannot access - you need to be a client.
I don't know how much influence that broker advice has on volume and price, but I reckon it's got to have some when there's a big gap between a broker's target price and the actual price. It also exposes the Alchemia name to a wider audience, which has to be good for volume as well.
I hope all the ACL staff with options that could be about to make make them very rich don't lose their drive after fondaparinux is done and dusted. Role on HyAct.
gambier33
15-01-2010, 03:10 PM
Just found the latest RBS Morgan report (publ date 14 January 2010) on Alchemia's website in the "Investor Centre/Analyst Reports" section:
http://www.alchemia.com.au/IRM/Company/ShowPage.aspx?CPID=1482&EID=11379096&PageName=RBS Morgans
cheers, gambier, and an exta 10c if we get approval through. also, it's great to see how even small increases in market share make a big difference to the bottom line. moreover, the pipeline just looks great. i look forward to the time we are taking fonda for granted and can focus on HyAct. c'mon FDA! still, i'm enjoying this rise in the sp. ACL has been very good to us in the past 9 months, but heaps more to come if all goes well.
-j
gambier33
11-03-2010, 04:57 PM
The FDA's Office of Generic Drugs is taking a while to give an approval to ACL's generic Fondaparinux, but it is hard to see any reason for concern. The OGD are currently flooded with applications and are under funded (to quote the Generic Pharmaceutical Association - http://www.gphaonline.org/issues/ogd-funding).
GPhA state that the average approval time is out to nearly 21 months. That would put Fonda's approval out to the end of this year, assuming that the waiting time was 21 months when its application was lodged a year ago:
Given the critical mission of the FDA to protect the public health, GPhA has been a strong advocate of adequate funding for the Agency to fulfill its mission. GPhA supports providing the Office of Generic Drugs (OGD) an additional $14 million for the specific purpose of reviewing and approving generic drug applications which would ultimately result in greater cost savings for consumers and state and federal governments. This increase would bring total OGD appropriations to approximately $54 million.
Key Points
The number of generic drug applications -- Abbreviated New Drug Applications (ANDAs) -- submitted to the FDA each year for review and approval has more than doubled over the past six years, from 361 in 2002 to 830 in 2008.
This influx of generic drug applications has resulted in an accumulation of about 1,400 unapproved filings, which now are awaiting action by the FDA's Office of Generic Drugs. Median review and approval time for ANDAs has swelled to nearly 21 months – more than a year longer than the statutory six-month review period allowed by federal regulations.
This situation could worsen over the next five years as patents expire on brand-name drugs totaling more than $100 billion in sales, resulting in a surge in submissions of generic drug applications.
The FY2009 budget for the Office of Generic Drugs is approximately $41 million. Over the past eight years, OGD has seen only very minimal increases in funding, and in some years was flat-funded. This has occurred even with a staggering three-fold increase in the OGD workload.
The lack of adequate funding has resulted in delayed approval of new generic drugs, which in turn has cost the government billion of dollars in lost savings. Because generics cost 30% to 80% less than brands, a one percent increase in generic utilization nationwide equates to approximately $4 billion dollars in annual savings.
pleased to see you're still about, gambier.
this wait has been painful, but i'm still in this one big time. i've given up saying (and hoping) that approval must be soon... although i feel certain that one day we will be rewarded...
-j
gambier33
12-03-2010, 03:52 PM
I'll wait it out, -j, but this paint is taking a long time to dry. Nice 5% jump currently today (13:45 ESDT) though. Volume up as well. Smart time to come in for newcomers as they don't need to be as patient as you and others have been. Although I'm not a TA person, I think the trend may have turned and is slowly up again. Here's hoping we don't have to wait much longer. Cheers
after such a long wait i find it impossible to consider jumping ship now. i am pleased by the oral fonda partnership. it's great to see the co is not sitting on its hands while the FDA deliberate. if that comes off it could be a tremendous development.
-j
gambier33
09-04-2010, 01:16 PM
Hi jdg, I'm like you - been in ACL so long now, that waiting it out is the best option for me. Impatience would probably be my undoing! FDA announcement has to be in the next month or two! I check the FDA ANDA site (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu) every morning, hoping to get an early preview of the fonda approval, but no luck so far. Cheers.
floyd
10-04-2010, 12:41 PM
im stil here too guys.... its been a bit of a wait so far
gambier33
10-04-2010, 06:25 PM
im stil here too guys.... its been a bit of a wait so far
Hi Floyd, great to see you're still in the wait. It'll be a day/week of celebration for me when FDA approval arrives.
Anna Naum
26-08-2010, 01:36 PM
Hi Floyd, great to see you're still in the wait. It'll be a day/week of celebration for me when FDA approval arrives.
RBS Morgans research report suggesting the wait is nearly over. Get your dancing shoes out.
floyd
26-08-2010, 01:46 PM
and heres the report..... bring on the expected approval
http://www.alchemia.com.au/irm/Company/ShowPage.aspx?CPID=1568&EID=82409122
Nice find. These reports coming out are all the same, as nothing as changed in there business. It's just about waiting for this FDA..
2 months over the average approval period now, surely it can't be far away!
gambier33
27-08-2010, 11:04 AM
I'm still in. What a wait!
Anna Naum
11-09-2010, 10:06 AM
Why are we still waiting....good because it is bigger than expected or FDA deal is dead?
gambier33
11-09-2010, 11:52 AM
Anna, I reckon it's slightly bad. Not because it won't be approved by the FDA but, because of the time cost of money, revenue delayed is a loss of value.
I don't think it can be much bigger than expected, apart from the organic growth in the innovator drug's market (Arixtra) means the market for the first generic fondaparinux (ACL's product) will be that much bigger. Down side to that is another company has also claimed to have lodged a FDA ANDA, and if they do get it to market, two generics get a much lower price for their product than just one fondaparinux having the generic market to itself. It will be priced almost at the level of Arixtra.
ACL still has a pipeline of projects and, although many, me included, have all tended to focus on the FDA/fondaparinux story, these have value that's probably not reflected in the current share price. I reckon fonda will be approved within the next couple of months (FDA is now starting to approve other ANDAs within the same application number range and the fond ANDA is getting close to what the FDA currently advises is the approval time for first generics). The de-risking that FDA approval gives ACL and the guaranteed revenues/end of cash burn should see a major jump in share price which is currently around AU$0.49. Of course I want that new level to be around $2.00 ;-), but when I hose myself down and cool off, and put brain into gear, I think a new level around AU$0.75 is more likely. I'll be happy with that! I've been in for a long time (some shares picked up in the float!) and my weighted average entry price is below 20 cents (Aus). Revenue allows ACL to crank up development of their other pharma targets.
Anna Naum
11-09-2010, 12:21 PM
Thanks gambier33, well considered thoughts. I think these guys have an interesting development pipeline and getting this approved as you note, allows them to invest in the business. 75c would make me happy as well.
Anna Naum
14-10-2010, 02:54 PM
14 October 2010 ASX / MEDIA ANNOUNCEMENT
Fondaparinux Update
Alchemia Limited (ASX: ACL) (Alchemia) has been informed that the facility in which syringes are filled with fondaparinux will be inspected by the FDA in November. This facility is currently FDA approved and fill/finishes a number of marketed products for the US market. The examination of the data on fondaparinux is part of a routine periodic inspection that will also include other drug products. Whilst not always required, FDA inspections regularly take place prior to the approval of products.
Peter Smith, CEO of Alchemia, said “whilst we can’t predict the timing of final approval, we are encouraged by the progress of the ANDA for fondaparinux at the FDA.”
Great news. Ok it's another month but at least we know what is up.
You can bet the FDA would not be sending this off for needle inspection unless the product has met the test. I'll be researching this non stop in the mean time, as if it is definatly the case, I'm filling my boots.
This will be a $1 before xmas, it hit 80c+ on speculation of approval, and this note here could well be an approval..
So many generics who submitted after ACL have been approved, this is our time!
if nothing else it's nice to hear from the company. while the wait has been rather painful in its duration, i have been accumulating of late as approval can't be too far away and the sp will skyrocket when the FDA give it the thumbs up. let's hope this inspection is linked and approval arrives in december. i think we will see $1 on the news. moreover, i agree with gambier in that currently ACL's pipeline is not factoring in the sp, but when the risk for fonda is removed, eyes will turn to this - and , in particular, HA-irinotecan. there's a long way to go for HA-irinotecan, but if the next stage of testing confirms its efficacy, the market is massive and its value to ACL will dwarf that of fonda. we also have VAST to consider and oral fonda as well. in both the short and medium terms, this is hands down my favourite stock.
risks exist, of course, but given reedys experience with ANDAs and generic drugs, i think these are minimal.
i've filled my boots with ACL and i sleep like a baby. i think this one is a real gem.
-j
gambier33
14-10-2010, 08:41 PM
i've filled my boots with ACL and i sleep like a baby. i think this one is a real gem.-j
I couldn't have described my own situation any better than you have with that quote. November for approval!
COLIN
14-10-2010, 11:05 PM
My experiences with bio-techs haven't been all that encouraging but, following the fillip in July, I decided that ACL might just be the exception. Today's announcement gives me hope.
Colin I think your comment is well timed. It is tempting to 'fill your boots' on this.
Everything I hear on ACL is no risk, $$$! But I've never held a Bio tech for any long period of time, or at all through and FDA process. This and some storys I've heard from other Bio techs has held me back a tad.
Still - love this stock! Very interested to see how this will trade early November. If the DOW holds up through this time, I think this could get back to it's 80c pre approval price..
she's very quietly moving up. given the fact that approval appears to be close (both on average time taken and the fact the facility is being inspected), i may have expected a slightly quicker rerate, but perhaps that's coming. either way, she'll find fair value once the decision is made. next month may well be it.
-j
Anna Naum
04-11-2010, 01:27 PM
Announcement from the company with RBS research report (BUY).
Alchemia Light at the end of the tunnel
In a recent interview, Dr Reddy's targeted 4QCY10 as a potential approval point for fondaparinux. GSK has also reported solid 3Q10 sales numbers for Arixtra, recording US$67m in sales in the US market. The next major catalyst is the approval of ACL's generic fondaparinux, Buy maintained.
www.alchemia.com.au/irm/Company/ShowPage.aspx?CPID=1611&EID=64823075
nice bounce today. a sign of things to come!
-j
COLIN
08-11-2010, 09:42 PM
nice bounce today. a sign of things to come!
-j
And I'm still there with you, jdg - in case you're feeling lonely!
ACR still running with the bulls, too.
gambier33
09-11-2010, 12:32 AM
Hi jdg and Colin, you won't be lonely in following ACL! Does three make a crowd? I'm still with you on this one. Cheers.
Anna Naum
09-11-2010, 07:50 AM
Hi jdg and Colin, you won't be lonely in following ACL! Does three make a crowd? I'm still with you on this one. Cheers.
Make that four, I have not been in it as long as some of you, bounce yesterday was interesting and on reasonable volume for ACL.
i'd bet a dollar that floyd is still with us too.
it will be interesting to see if we see a pull back today or if it continues to surge.
after such a long wait, it's just starting to get a bit exciting again. the finish line seems so very close. although, when you're running a race in the dark it's impossible to know... (i was expecting approval this time last year!). still, given the plant inspection, and the average approval time for ANDAs, there is reason to currently feel confident of a near term resolution.
-j
floyd
09-11-2010, 11:14 AM
your on to it jdg, im still here....... id bet a dollar on approval eh
making a few dollars in the meantime, floyd, as ACL continues to move up in anticipation. pleasing to see.
i'm keen to get fonda out of the way so we can concentrate on HA. management is pretty bullish on its prospects by all accounts.
-j
Yep, not sure if you guys are following some of TDA's comments on HC, put word is Peter said the inspection tests are going well, and have passed everything so far with one small final check left. Also that this is the last step, and FDA will be given after it.
But the AGM preso, and last investor pack has really suprised me around the potenial in HA - I invested in this company soley for Fonda, then was going to exit around $1 on approval. Sounds like Fona is merley a stepping stone to better things, and HA is going to be the true earner.
Exciting times!!
well, with November over we can assume the inspection has been done and therefore there should be no further impediments to approval.
it's time to do what ACL holders have learned to do best - wait.
that and perhaps wonder what size bounce we'll get on approval. in recent times i have predicted $1 (which seem to be a nice round number and is a common guess among many ACL punters). I’ll stick with that, but it may prove to be on the high side if people choose to sell the news. it may take a week or two to find its true level.
let's hope we find out this side of christmas.
-j
Yep sounds like there was 2 inspections, pete at the AGM stated the first went fine, and the second was underway. With the AGM being over a week ago, we have to assume this has gone well. He also said FDA would come through after that.. It must be in the final stages, maybe the FDA fax machine is broken? I don't know.. Like you said, ACL holders are use to this and will cope..
Below are some notes taken by someone who attended this AGM - which by all parts sounded very bullish, more so than what we read in any investor preso's
======================
Here are a few things I found interesting and I suggest everyone go over the presentations because there is a lot of new info in there and is rather comprehensive.
My notes (I?ll try to keep most of what?s in the presentations out):
VAST Technology ? Due to the size and scope of staffing needed to progress this in-house the company has decided to try and realize this technology through collaboration instead, they have been very busy this year signing several deals with major pharma companies and smaller ones as well. This in turn may return a lot of capital to the company so they can progress with and concentrate more on the commercial opportunities we have with Fonda (including Oral) and the HyACT platform (including the phase 3 HA-Irinotecan trial for colorectal cancer and phase 2 HA-Irinotecan trial for small cell lung cancer). Watch this space, they wont be vocal about it but there could potentially be one big or many smaller deals done here.
HA-Irinotecan ? The trial will now cost $25m instead of the stated $20m due to the change in Protocol and in turn the need for more patients, going from 330 to 390. They wish to make sure they capture all data needed hence the increase in patients. This was referred to as ?our phase 3 asset? many times and Pete Smith believes that the market will add significant value to it (shareprice) once the FDA approve Fonda, they seem more excited about HA-Irinotecan than they do Fonda, it was mentioned again that this has the potential to earn ACL 100?s of $millions and we are clinically further advanced than the competitors (eg PEG ? years ahead). They may start a partnering campaign early next year once the trials have started, P.S said again though that they don?t need it and if they were to partner it would have to be a deal they couldn?t refuse, he is really bullish on this one.
Fondaparinux ? Well we all know what we are waiting for and jeez it sounds very close. Pete said that FDA actually had 2 inspections to do and that the first one was done and the second was to be within days. The clincher, he mentioned that they expect it to be a matter of only weeks after this, but wait there?s more:
They were told by the FDA that there are NO further questions to answer and that the inspection is the only thing left!!
Pete expects a rapid take up of Generic Fonda and mentioned the Generic Enoxaparin (same space) stealing 45% of sales in the first 9 weeks, he said it is a simple economic switch by patients and hospitals to the cheaper alternative.
For Tewk, we can submit for European approval by the end of this year, ready for sales in 2012, Reddy?s will be doing this.
============================
gambier33
30-12-2010, 05:46 PM
Looks like 2011 now for fonda FDA approval. It's a cracked record, but: "what a wait!"
Looks like 2011 now for fonda FDA approval.
it better be!
the price is pushing up in anticipation, but i've given up thinking it's ever close. what a wait, indeed.
-j
71c (11%) on huge volumes, is it this week??!
another good day, fill and finish inspection completed....i refuse to think this could be it... but it is looking tidy.
-j
COLIN
11-01-2011, 04:51 PM
Holding and hoping.
For those who loaded up in July-Sep (35c low) this one should be approaching a multi bagger
We have gone on a few runs like this in anticipation, or following a bullish preso, and going by them they usually last for about a week. This run has a pretty good chance to carry on. But, we also know with no news this quickly fades back..
Well, I'm hoping the run gets interrupted by a nice FDA announcement which will make the 14% of the last 2 days look pitiful. Hoping for $1 plus
well, i'm pleased it has held 70c after the post xmas surge. we now have a reasonable launch pad.
perhaps the quarterly will shed some light on where we are at with the FDA.
-j
For those who loaded up in July-Sep (35c low) this one should be approaching a multi bagger
We have gone on a few runs like this in anticipation, or following a bullish preso, and going by them they usually last for about a week. This run has a pretty good chance to carry on. But, we also know with no news this quickly fades back..
Well, I'm hoping the run gets interrupted by a nice FDA announcement which will make the 14% of the last 2 days look pitiful. Hoping for $1 plus
Well that 'fade' back has happened, as it's done about 4 or 5 times following these little bursts of excitment.
This is my first ever entry into bio techs, and has probably scared me off any other investing opps. The wait has just been crazy.
Now today, pretty big drop as the CFO and coy sec resign. A pretty funny time to call it quits in my books, would these guys have been in line for some kind of bonus at 30 june for any fonda sales? After years and years of working on a project like this I thought you would want to stick in for a little longer and see it through. Is it now more than a little longer???...
The market dosen't like it anyway, down strong.
damn, this wait has become excruciating.
ex-bloody-cruciating.
i think if i meet anybody who works for the FDA i'll beat them half to death.
even if they are only employed to answer the phones.
i need to find an ACL support group.
i have found that liquor helps, though.
ask charlie sheen. a big ACL holder.
-j
Director buying at 74c
This agonising FDA wait has had me thinking of all possibilities. But a director buying on market re assures us ACL is in the same boat as us, and just waiting for approval, not knowing much else...
A director selling right now – that would scare the pants off me..
From todays update..
"Alchemia anticipates the next communication from the FDA to be the product approval itself"
And boy this need this soon as cash is getting tight..
I haven't posted in a while, but I just gave comment to OEL and thought I'd pass my sympathies on to holders of another stock that has been waiting for news for FAR too long. I'm picking there are a few stayers here; good god this stock and the FDA are driving me crazy. If I get an ulcer, it'll have nothing to do with the Christchurch earthquakes....
Let's hope we're nearly there.
Good luck, and I hope you're all well.
-j
floyd
10-05-2011, 08:07 PM
still here as well jdg... fda is certainly trying on the old patience
was in chch last night, that 5.3 was a bit of an early wake up call... heard the bugger coming
Same here.
I'm now finding the wait pretty easy, as it has been so long I've got to the point where I forget I even hold ACL as there is nothing to check up on.
I am well over exposed to this stock.
And I worry the longer this goes on, the closer we get to the next announcement being another capital raising. I would prefer them to use debt if possible as the $$ could come in quick fast in just a few months following it, but then again, what if it doesn’t??
Great value now though - for those who are unaware this has passed every test in the book. The plant inspections were told to be the final test, which came back good. The next comms are stated to be FDA approval itself. The Fonda market is just growing crazy:
FY10 totals (FY11 sales so far up big on FY10):
US = US$274m, Europe = US$154m, ROW = US$39m
ACL should get 1/2 of the USA minimum instantly, and then apply for Euro and ROW as those patents expire very soon. On top of this, ACL is working on an oral formula, a world first.
On top of this is another drug at phase 3 stated to have value which make fonda look like petty cash, and another one behind that.
Buns, i was always of the mind that we should have moved on HyAct stage III earlier rather than waiting; either through a cap raising or a partnership. we are just in limbo at the moment and at the mercy of an overworked agency. i think managment have made an error here.
good see you still about, floyds. as for the earthquakes, i think i enjoy them more than ACL at the moment.
regards,
-j
In hindsight I think you are correct.
However ACL had no idea the fonda approval would stretch out this long (when it last did a CR), they would have expected cash flow quite some time ago.
Tough one to get right
drillfix
11-05-2011, 02:48 PM
I'm now finding the wait pretty easy, as it has been so long I've got to the point where I forget I even hold ACL as there is nothing to check up on.
I am well over exposed to this stock.
Sheezus Buns, how long have you held for? Not sure how anybody can be over exposed to such a stock and then just pretend you dont own it or forget about it? lol
Ever think about swapping some or half of your position into another same priced stock perhaps moving in your favour or another sector?
Just some thoughts that's all~!
that was a big day's volume for ACL and it was heavily down (on an up day for the market). i don't like the look of that at all. smart money leaving? no news is starting to feel like bad news. i still hold (big time), but with a shakey hand.
-j
Smart money leaving? Nope smart money was entering! Have a look at the director buying announcment.
I'm not sure what happened there, possibly stop losses being triggered
gambier33
07-07-2011, 03:58 PM
ACL missed another of their approval estimates with the passing of 30 June.
trading halt for ACL. could this be it?
-j
Surely?!!
Or a capital raising?
They have cash to last untill Xmas and a heap of ADNA approvals submitted at the same time of them have been accepted of late..
This is worth over $2+ on approval.
in other raisings ACL has mntioned this purpose when requesting a trading halt.
on that basis, i think a CR is perhaps unlikely (although they can't be too far away from needing one).
i'm crossing my fingers this is approval. but it's been such a long wait i can't muster any excitement as yet.
should shoot up to around $1 if it is the news we want (although a climb to $2 over coming weeks/months is certainly a possibility).
let's hope she's about to come good.
-j
i'm already up to my ears in this one... but if approval comes through $1 looks cheap. once revenues start to flow the market will wake up to ACL. also, when that happens, value will begin to be placed on the substantial pipeline.
i note that Southern Cross Equities recently valued ACL between $1.96 and $3.26
-j
how come you removed your post, buns?
-j
Dr Reddys have started trading in India - no ann there or here. it suddenly doesn't look like approval....
-j
IT'S APPROVED!
Wow, great stuff. Now let's see how the market reacts.
-j
IT'S APPROVED!
Wow, great stuff. Now let's see how the market reacts.
-j
3 years I've been waiting for this
:) :) :)
you aren't alone, mate. there will be a few of us celebrating this news. where's floyd and gambier?
also, as i noted in an earlier post, i think this signals the beginning of a rise oover several weeks/months as the market wakes up to the potential. it's going to be great!
-j
Maybe those guys are off drinking cheap beers on the couch like I have been?
Today was a relief on many levels:
a) A reward for my 3 years of patience and accumulating in the 40c range whilst not taking my eye of the end prize
b) It spells the end of a large speculative share in my portfolio
c) I got a tad lucky I suppose..
As I said, I bought ACL years ago and since then have learnt so much more about investing to the point where I would never buy an 'ACL' in it's pre FDA state again. I made my mind up on this kind of thing a while ago, and then the PXS disaster happened and I was very close to cashing up my ACL shares. If I could have found some undervalued stocks in the market, ACL would have got the nudge a while ago, but I couldn't then today happened.
Now? ACL ticks all my boxes. It is a well-managed company with a huge economic moat which will produce rising profits for quite some years. Hence I'm holding this one for a long time (assuming they maintain these qualities).
Well done to the others who did well on this, BUT don't let it get to your head in the future and go trigger happy on bio-tech's or spec investments.
well, after a 30% rise on day one, we are now dropping back. in fact we are at levels we have been at pre approval. huh?
here i was waiting for a spectacular rise, when it seems i was in fact waiting for godot. bloody hell.
we must be a takeover target at these prices. surely?
back in to the bottom drawer they go.
-j
floyd
25-07-2011, 11:23 AM
im still around, just been indisposed for a couple of months
bit surprised by the price action, be interesting to see what happens over the next few months
Anna Naum
25-07-2011, 11:26 AM
1/4ly out today looks to me like there is a need for a CR very soon
steve fleming
09-08-2011, 08:39 PM
Not very good news that there is a generic coming out.
Biotech's hold far too much risk for me - i stay right away from them for reasons like today.
It's not great news, but not the worst.
The generic is just another product spin from within GSK. I don't know game theory to well but GSK must be assuming they can make more money from Product 1 and 2 v ACL compared to just product 1 v ACL. I'm assuming they know the fonda clients pretty well and expect take up for Arixtra to carry on for a while with their new generic being priced cheaper to harm Alchemia a tad in the short term in places they don't have relationships. Sounds like a viable strategy. i.e instead of competing 1 for 1 and losing 50%, with 3 they may only lose 33%
Alchemia (Actually DrReddys) will have to price cheaper to get decent market share. The thing is, they have priced this generic at 8% less than Arixtra! Hardly anythiing, everyone assumed Dr Reddys would near the 15-20% discount to Arixtra. Well they could essentially still do this and their longterm sales of fonda would probably be the same assuming demand for the expensive Arixtra (only product everyones aware of) reduces.
Speculating a tad, but this news is no where near as bad as the headline. Another real generic would take 5 years or so to hit the market, and if Arixtra does hang around grabbing market share possibly this will scare off a 4th product from entering all together?
There are 2 larger problems here:
1. ACL has no cash
2. Fonda is not the greatest
1. Pretty simple really, they need cash to fund there flagship HyACT programme which from all accounts is the goods. Success with this will put 2 zero's in front of the SP, and it wasnt so long ago a similar technology was sold for around $600m I think. Anyway, cash again... The intention was US debt.. chances of that are iffy now, even at 70c Pete stated he does not want to CR at those prices, but his hand may be forced now. Also with GSK putting out this cheaper generic they will probably downgrade their 2012 cash flow forecast hence need more than they thought a month ago.
2. This is just from reading around and talking to people in the know. Not many like the drug, not many want to use it and it does nothing to special. Fonda from all accounts probably will not be around for a long long period of time, and when it does stop, it will be like a stick in your spokes for ACL if they have nothing else.
The thing is, ACL does have something else. ACL will never be a single drug bio-tech, instead they are all about there HyACT formulations, a technology which is typically bought very quickly by a major.
All in all, I would rather not own ACL, but it is for none of the main reasons you see on these boards. It is because I don't know what they will look like in that 5-10 year window. Turning back to my 1-2 year horizon, ACL is stupidly cheap.
floyd
28-09-2011, 11:10 AM
here we are vegemites, a bit of positive news .... well maybe a bit more
http://au.news.yahoo.com/nsw/latest/a/-/newshome/10354286/treatment-gives-cancer-patients-hope/
floyd
28-09-2011, 03:30 PM
old news.....????
it was meleased last night and on the asx this morning
Hyact has proven large reductions in tumours for quite some time, and Pete has mentioned it multiple times in presentations.
Today the media got onto it and put some faces and real stories on top of the facts.
So nothing new overall, but good to see the results continuing in this new test environment.
The bigger issue right now is funding – this may help them raise debt or even attract a buy in partner. However, I’m starting to think (probably wishful), the more this is delayed, the better chance fonda sales have been high year to date. The announcement of fonda funding Hyact would be huge.
These revenues will be out in a matter of weeks
Joshuatree
03-10-2012, 01:56 PM
Likewise to WDS is ACL .Piefunds expecting even bigger gains shortly with little downside. Certainly PIE have a great track record.
Powered by vBulletin® Version 4.2.5 Copyright © 2024 vBulletin Solutions Inc. All rights reserved.