Eco Animal Health Share Discussion Threads

[audigger] 09/8/2011 13:08

Well these are suddenly cheaper. Have added albeit not many as ain't got much spare cash at the moment. If these get to around 190, then I'll be selling some other shares to buy more as, market chaos aside, these are looking a very attractive prospect once FDA approval is granted

[ltinvestor] 25/7/2011 09:03

..... and what about the anti viral potential of Aivlosin.Research is continuing in 3 countries on this possibility and a positive outcome will have a major impact on the value of EAH.£6min without this according to Cenkos.What price with it?????

[roverite12] 24/7/2011 14:09

It's almost inevitable IMO that a takeover bid will occur after Aivlosin's full potential becomes apparent in the coming months .

[topvest] 23/7/2011 17:15

Interesting...particularly this bit...

The broker pointed out that ECO's business model uses third-party distributors who earn up to 50 per cent margins. If the company was acquired by a multinational animal health business, with its own sales force, then the gross profit contribution that could be achieved would be nearly treble that currently produced by ECO.

[roverite12] 23/7/2011 14:51

PROACTIVE article - dated 4pm 22 JULY

Shares in ECO Animal Health Group (LON:EAH) were higher by 6.6 per cent at 235 pence each by 1pm today, after the company said its current financial year had started well and reported a strong increase in profit and revenue for the 12 months to 31 March.

ECO, which makes environmentally-friendly drugs for livestock, said it had seen positive trends in many of its key markets. Demand from China, its largest market, is strong and it continues to build a presence there and in other important territories. The firm added that it was optimistic that it would soon receive clearance from the US Food and Drug Administration to begin sales of Aivlosin – its flagship drug that is used to provide control of major respiratory and enteric diseases in both pigs and poultry – in that country.

Today's results showed that the group increased its turnover for the year to 31 March by 24.4 per cent to £27.1 million (2010: £21.7 million), while its profit – before non-cash charges such as tax, depreciation and amortisation – improved by more than 16 per cent to £6.4 million.

On average margins were slightly lower, restrained by currency movements such as last year's strength of sterling against the US dollar as well as by the regional mix of Aivlosin sales and an aggressive local pricing policy to secure large tender business in Brazil.

But sales growth in key markets was strong. China, India and Japan posted growth in excess of 40 per cent, while Latin America and South East Asia saw growth exceeding 25 per cent. Sales from ECO's Chinese subsidiary Zhejiang ECO Biok Animal Health Products were greater by nearly 30 per cent in the local currency (and by close to 35 per cent in sterling).

ECO said it believes that China remains the market with the greatest potential for its products and it is continuing to seek further opportunities in the country. After China, the US – a market that represents about one third of global demand for animal health drugs – is the next major market that the company is targeting and it expects to launch there soon.

The US FDA is still studying ECO's most-recent dossier submission to allow the firm to obtain its first Aivlosin marketing authorisation for a pig claim, while more work is being carried out so that further claims for Aivlosin in the US can be added in the near future.

ECO's Japanese subsidiary, ECOpharma, exceeded expectations during its first full year of trading. Following the earthquake in Japan in March 2011, the business's staff and customers remained safe from danger and business returned to normal quickly, ECO said.

Europe was broadly flat during the year, reflecting challenging economic conditions in the region. But the firm added that the UK was a notable exception with ECO's new direct-to-market strategy, together with the launch of Aivlosin for 'bulgy eye' – a respiratory disease of pheasants caused by mycoplasma – being well received, delivering sales growth of more than 40 per cent.

Cash generation at ECO continued to be strong during the year, with £8.5 million generated compared with £3.3 million in 2010. The firm said that this was achieved thanks to the ongoing implementation of its aggressive stock and debtor management policies

ECO has declared a dividend of three pence per share for the year – an increase of 30 per cent over the 2.3 pence it declared for 2010.

"ECO Animal Health Group has delivered another strong set of results for the year ended 31 March 2011 and the current year has started well," said Peter Lawrence, ECO's executive chairman. "Overall, ECO is well positioned with an excellent product range, exciting growth opportunities and potentially very important new products in the development phase. The company is poised to accelerate its growth and continue to deliver value to its shareholders."

Cenkos Securities, ECO's house broker, believes the group is close to receiving marketing authorisation for Aivlosin in the US. "This represents a huge opportunity for the group although the timeline (which is outside of ECO's control) has lengthened beyond our original expectations," it said.

Cenkos forecasts revenues for the current financial year to 31 March 2012 at £30 million, with adjusted pre-tax profits of £3.1 million (translating to earnings per share of 4.2 pence).

The broker pointed out that ECO's business model uses third-party distributors who earn up to 50 per cent margins. If the company was acquired by a multinational animal health business, with its own sales force, then the gross profit contribution that could be achieved would be nearly treble that currently produced by ECO.

For this reason, Cenkos believes that ECO could be worth 600 pence per share.

[audigger] 22/7/2011 13:39

I think the company were asked to provide FDA with additional information and/or clarify questions they had as ECO refer to thier most recent dossier submission "The Food and Drug Administration (FDA) in America is still studying our most recent dossier submission to allow ECO to obtain its first Aivlosin® marketing authorisation for a pig claim. Concurrently, more work is being carried out so that further claims for Aivlosin® in the USA can be added in the near future. Timelines continue to be extended and, as ever, this is completely out of our control". This is all part of the normal proceedings for a new registration but is unfortunately very time consuming.

[topvest] 22/7/2011 10:33

Yes, all very positive. Are the FDA the slowest organisation or what!? Patience needed, but expect they will get the approval soon.

[ltinvestor] 22/7/2011 09:08

I am just looking at my portfolio to see what I can sell in order to increase my already substantial holding!!

[audigger] 22/7/2011 07:59

And a reasonable 3p divi

[audigger] 22/7/2011 07:42

Wasn't expecting the results until Monday, looks like they are out early. This is an impressive set of results and interesting that they are taking steps to increase liquidity. Canadian approval is always a good benchmark of what may come from FDA so I truly beleive FDA approval will happen this year. I'm also impressed with their approach to currency movements. Looks like a very well run company. Given that this is positive across the board and that it is likely to be a blue day all round I'm expecting a big (circa 20 p) jump today....

[topvest] 06/7/2011 20:28

Yes, so am I - could take a few years though. Patience required but should be a good reward eventually.

[ltinvestor] 06/7/2011 09:19

I agree Topvest that the FDA approval is so material to the company that it will need to be announced once known.We should at least receive an update on progress on the 25th unless, of course, it has been granted prior.I am still confident that a takeout in excess of £5 per share will be achieved and note the activity at Axis Shield today.

[topvest] 04/7/2011 21:21

Yes, sounds good. The FDA approval would need to be announced once it is known rather than waiting for the results though. Patience required, but no doubt it will be granted at some point.... maybe in a few weeks, months or years!

[audigger] 04/7/2011 10:27

A bit of news at last and a hint that things are going well. May we finally get news of FDA approval on 25th?

[audigger] 15/6/2011 15:55

In the meantime, the company has to wait to get full value for its IP. FDA should compensate!

[ltinvestor] 13/6/2011 07:58

The delay just goes to show how difficult it is to obtain FDA approval for a drug which is already approved and being used in many countries globally.It also shows how valuable this drug will be once approved. I look forward to the day!

[audigger] 27/5/2011 21:45

Have been trawling FDA's website in search of any clues as to pending US approval for aivlosin. One intersting point I noted was that EAH appear to have a lead regulatory person in the USA by the name of Dr Robert Dodemaide (Director, Regulatory Affairs & Compliance at ECO Animal Health). I was able to find some transcripts from some generic discussions involving FDA and insustry in which DR Dodemaide features. I've copied some of this below. Most of the subject matter is irrelelevant to Aivlosin approval in the USA but, as is the way of things with chemical approvals, he is likely to be the key interface between EAH and FDA in terms of securing FDA approval of aivlosin.

DR. DODEMAIDE: Good afternoon. My name is Robert Dodemaide. I work for Eco Animal Health, and my office is located in Princeton, New Jersey. Headquarters is in London, UK. Comments on two different subjects. Firstly about what should be the title of the person who could be Steve Sundlof in the EU, and the title suggested was a MUMS Czar. My suggestion is Big MUMA.
(Laughter.)

DR. CRAIGMILL: You might be earning yourself 10. Keep going.
(Laughter.)

DR. DODEMAIDE: My second subject is about MUMS and I have sort of entitled it data package transfer from jurisdictions where a use is a major use to a jurisdiction where a use is a minor use. There have been several examples shown during the course of the day. For example, sheep is a major use in the UK; sheep is a minor use in the US. Turkeys is a major use in the US, but a minor use in Europe. So I will just read some comments that I jotted down, and I will give these to the recorder over there when I'm finished if that makes it easy.

All regulators want products which are safe and effective, and to insure that we have VICH guidelines, we have Codex procedures, we have JECFA to make various determinations to insure that this happens more or less on a global and a harmonized scope. Products for major uses go through a rigorous review process for quality, safety, and efficacy. We all know that. Major uses in one country may only be a minor use in another, and I gave a couple of examples of that. Turkeys in the US, major, minor in Europe. Sheep in the UK are major, minor in the US.

A data package from a major-use country should be accepted in a minor-use country. I think really accepted in fact because this package which has come from a major-use country has gone through a rigorous review process. I am using those two examples of sheep in the UK and turkeys in the US for those products that have an approval where they are a major use. They have gone through a very rigorous process, and I think the package should be able to simply be transferred post-approval in the major-use jurisdiction to the jurisdiction where it is a minor use.

I think this system would provide a package of data that is of good quality data that might otherwise not be available in a minor-use jurisdiction. So for example, if we ignored what happened in Europe and wanted a sheep approval, you would have to go through the MUMS procedure here and perhaps generate data which are not complete in the normal sense. Whereas in the UK, there would be a complete data package available for say an anti-parasitic drug for use in sheep. So under this proposal I would say the quality and safety should not be a problem. The manufacturing of this product would already be underway in the country where it is a major use beyond the CGMP, and that probably could be exported to the country where it is a minor-use jurisdiction. Safety should not be a problem because in the major-use jurisdiction it has gone through this rigorous process. There has been an ADI, a safe concentration, safe MRL, et cetera, and really what is acceptable in one jurisdiction where it has a rigorous review process I think should be accepted without too much question where the minor-use is proposed.

There might be some problems with it, but I think the quality of the data generated under this sort of a standard would be far superior to that which might be generated under the MUMS proposals that we have been sort of talking about today. I think a sheep anti-parasitic drug efficacy package generated in the UK would be a rigorous package which would cover several species, and it would be a much more complete and thorough package than might be generated in the US under the MUMS procedure.

I think my final bullet point here would be the label for a drug approved under this data transfer, data package transfer scheme, could be a new label if it was the first time the product had been approved, or it could be added to a current label. I am not sure if that would raise any legal questions, but perhaps it could read "approved, FDA in parens, MUMS" or something like that, just to show to the consumer that the full safety and efficacy package was not generated in the minor-use jurisdiction. All that data came from overseas. So that is just my thought on a data package transfer from a major-use jurisdiction to a minor-use jurisdiction.

DR. CRAIGMILL: Okay. Thank you very much, and you also have the opportunity to participate in the discussion with respect to all the other things. Was there anyone else who wishes a public comment? We have two, so what is our time? I guess we will have to give you each three minutes this time. Roz? Sandy, would you set it for three?

[audigger] 11/5/2011 15:04

And an share price of >500! That would be nice.

[ltinvestor] 11/5/2011 08:35

>Audigger.Once FDA approval is received they will be knocking quite loudly on Eco's door.I think that £300m would be achievable.

[audigger] 11/5/2011 08:27

All quiet on the EAH front. I thought this FT article was intesting in that there are two companies actively seeking acquisitions on the animal health front:

Sanofi to expand animal health business
//10 May 2011
Sanofi-Aventis plans to cut costs and expand its animal health business through acquisitions as it fully integrates Merial after the collapse of its longstanding joint venture with Merck of the US, The Financial Times writes
As of Friday May 6, Sanofi-Aventis shareholders approved a name change. From now on the company is known as Sanofi.
Chris Viehbacher, chief executive of the French pharmaceutical group, told the Financial Times there was scope for "synergy" in back office operations, manufacturing, marketing, and research and development.
He said the failure of the partnership meant Sanofi-Aventis would seek new takeover targets in animal health and plan to grow, notably in emerging markets where animal health sales contributed a smaller proportion than other divisions in the group.
Failure reasons
In the first detailed comments by either company on the reasons for the failure, Viehbacher said that the failure to recombine the two companies' animal health divisions was caused by difficulties in clearly defining market share and concentration in a way that permitted international regulatory approvals.
The process led to repeated delays and Viehbacher said that one cannot put a business on hold, stressing that both companies would have preferred to maintain the joint venture.
The current structure allows Sanofi-Aventis to fully consolidate its animal health operations.
Seeking acquisitions
He said Merial was likely to seek acquisitions "probably not of significant size" as it expanded, stressing that it generated only a fifth of its sales in emerging markets compared with a third for the group overall. It would also seek closer links to joint development of human and animal treatments.

[audigger] 06/4/2011 17:46

I have more experience with EPA aprpovals than FDA. EPA now operate a fee-paying system which places an obligation on them to evaluate new applications within a defined timeframe. That said if the agency rules the database incomplete the onus is back on the registrant to address the data gaps and timelines change. I'm not sure if FDA had open questions on Eco's data that needed to be addressed by the company or if the delay was purely down to FDA struggling to meet its work load. If its the latter, you would hope that ECO aren't punished in terms of time to off-patent. I'm working on the premise that approval will be granted this year, but have no insight as to when

[ltinvestor] 06/4/2011 15:51

Tightly held stock, mm's short and news around the corner.I have no doubt that Aivlosin will receive FDA approval but when I can't be sure, although I suspect sooner rather than later.The fact that the company haven't put a news release out recently indicates to me that they must be very close to achieving approval.

[joeblogg2] 06/4/2011 15:36

Au. I thought we would have FDA news by now??

[audigger] 06/4/2011 15:34

Nice to see this gaining some upward momentum again after the drift down. Will be interesting to see if it can get to 280 again even without FDA news. With FDA news it could go 300+ very quickly