Saturday 21 December 2013

Inavir approved for use in prevention in Japan

which is nice. It took just over a year for approval. The trials supporting the application were adequate, but from memory the first trial influenza season was influenced by the low rate of influenza spread in family contacts in the controls and it had to be extended another year.

Despite the efforts of NSA, it appears odd that the announcement came after the end of trading on Friday. This is despite news wires reporting the approval  hours earlier. Maybe confirmation needed to be made in writing by a certain DS official: but hours of good frothy trading were lost.

Having said that, the approval is good news but will make little material impact on earnings. Inavir would have been bought into the Japanese stockpile in any event, but this might see it extend favoritism past Tamiflu on effectiveness and convenience. Cost remains an issue.

Again, the froth will probably be blown off the share price in short time, unless bigger players start to become interested.

Hopefully, the next BOTA announcement with Daiichi Sankyo mentioned will be the most important: the details of the ROW royalty arrangement. It is extremely important that this occurs in a timely way and on terms favourable to BOTA.

A legal case around ROW Inavir rights would be terrible.

Have a Happy Christmas. The year to come holds promise for BOTA, but I've thought that every year for the last 10.




Thursday 12 December 2013

Hunter Hall AGM video presentations

offer a valid and consistent explanation for the BOTA sell down by HH.

They have had a clear change in guidelines and direction, from major (often controlling) holders with occasionally activist involvement to passive holders with a maximum limit of 3% holding of any company's stock.

They have sold down to that level in BOTA.

They have even sold down stellar performers like Sirtex, although they are making an exception to the 3% limit for them.

As I said, if it has helped the liquidity and hasn't hurt the share price, then fine. Just seems weird strategy.


Saturday 7 December 2013

Well, that was easy

Hunter Hall sells down to 1 million shares.

Why would they sell out, having offered critical support for the company's move to Nasdaq through all it's disastrous stages for presumably the rich benefits to follow? Instead they sell at the lowest price in years.

And especially if, having a seat on the Board, they know what the next 12 months has to offer.

Mr Hill will soon vacate the Board, I suppose.

Words fail me. I guess it's all to benefit the Hunter Hall shareholder or unit holder. Somehow.

We'll discover the buyers eventually.





Thursday 5 December 2013

Some increased institutional buying reported at

 http://whalewisdom.com/stock/bota

- it's a good site for tracking institutional activity in BOTA, and as you can see there has been a significant increase in institutional buying. However, it could be just the placement of the 1 million shares last quarter. It will be interesting to eventually discover where the last 2 million went.

Blackrock have bought into BOTA.

Doesn't recognise East Hill or Hunter Hall, though.

I wish these 13F filings were easier to find and more timely - need to find a better source.

Not that the share price has reflected this: we're back to $4 after that brief uplift.

The company has announced dosing for the Northern hemisphere LANI trials. The influenza season here in Melbourne was very late: cases in late spring!


Saturday 30 November 2013

2 million shares - Thanksgiving?

Like the Pilgrims, Biota left a hostile land for the promise of the better life on distant shores. Like them, we've found hardship, and wonder if we did the right thing.

It's fair enough for hedgers to think that 2 million shares crossing in a company with only 28 million of them might mean something might happen. Like the first accumulation in a takeover bid. They have bid up the SP after the fact and we all get a little pleasant sunburst of optimism through the grey sky. Sigh.

Don't get me wrong - I have no inside knowledge. Maybe they do. But if past performance means anything, all that's happened is that we've seen Hunter Hall lighten their BOTA load again. Only they and East Hill have that kind of block to trade. And no-one ever knows what East Hill are thinking. East Hill paid way, way above these prices for their BOTA shares. Maybe they want to take Prolysis' gyrase back, and continue to play baby biotech among the spires of Oxford, and sold out of BOTA to fund it?

Nah, too Tom Clancy.

If shaking out the HH and East Hill stakes helps liquidity without dilution, I'm all for it.

Damian Lismore's year is up and he's moved onto Nexvet.

And if Hunter did sell those 2 million, I think last drinks might be called for Mr. Hill's time on the Board.









Monday 25 November 2013

Oxford is a lovely place

but Biota won't have a presence there any more.

Prolysis's gyrase program was based in Oxford, and has continued there since Biota bought it in 2010.

But no more - the company has announced it will shut it down, and presumably the whole operation in Oxford goes. Prof Errington goes from the Board to potentially no longer being with the company at all.

I don't know whether that's a reflection of the competition in gyrase programs, or an assessment of their quality. It might have to do with the purchase of a new program. But, I have a feeling it has simply to do with reducing costs. Running two labs in two relatively expensive places, and neither leveraging each other.

The unwinding of Biota's last 4 years is nearly complete.

There are a lot of senior executives who oversaw and analysed the entry into those programs who are still with the company. Prolysis, Maxthera, rhinovirus: all cost the company probably in the order of 80 million between purchase and expenditure since then (although the first two were bought with hugely overvalued Biota shares).

Some Plumb and Patti type consultants would have been useful in 2010.

Anyway, here we are. The new question becomes whether the market will value the concentration in influenza and the step progress toward registration of LANI in the US. And what and how any new program will be purchased.

Saturday 16 November 2013

Is this a crazy idea?

Before the crazy idea:

1. AGM outcome.

Probably the most sensible proposal didn't get up. Decreasing the shares on issue needed a majority of the shares issued to vote in favour (cos' it's a constitutional change).

Which got me thinking, why aren't all AGM proposals voted on that basis?


2. Swamp people

It was interesting to see Mangrove Partners poke an air breathing root into Biota.

As we all know, they led the proxy war against the hapless Biota to suck back more cash and improve the terms of the merger deal strongly back toward Nabi. They pitilessly gutted the deal. We were the first and second stupid little pigs and they were the wolf. They blew the house down.

Tried as I might, I couldn't find the previous status of their holding. So maybe that massive 167 shares are new.

If so, then maybe they see another undervalued cashbox.

3. Crazy Idea

Here's a crazy idea. What if Australian Biota shareholders established another company. Let's call it Ozbiota Pty Ltd (OZBI). It establishes a constitution designed primarily to increase shareholder value through representation.

Every share you hold in Biota entitles you to a share in OZBI. You sign over voting proxies over those shares to the new entity.

It elects a board.

The company raises enough capital to run. Might cost 10 cents per share to play.

It then becomes a significant holder in Biota Pharmaceuticals.

As a service to shareholders, it could co-ordinate and facilitate trading on Nasdaq on behalf of all Australian holders. Yes, sellers as well as buyers. It could assist in voting at future AGMs.

Would it work?

Crazy, huh?



Monday 11 November 2013

Saturday 9 November 2013

First quarter 2014

The first quarter appears to show a steady course on the good ship Biota.

The loss of just under 4 million is essentially the cost of ongoing research programs, and those have reduced recently so I'd expect to see that figure drop a little further in the future.

BARDA pays for itself and almost all of Biota's general and administrative costs from the margin. As the BARDA contract spends more, there will be more paid in the 7% margin so the next year should see revenue increase.

I voted against the increased allocation to the Equity and Incentive Plan. I don't think it should have been put to us at this stage, even if I think the current management is better than the previous management.

The initial incentives offered as part of the current executive reimbursement are generous but reasonable in the context of the task ahead. But the Board should have delivered some gains for shareholders before asking shareholders to extend the Equity Incentives, especially with the proposed significant increase in the shares of the company. There hasn't been any traction in shareprice or even turnover as yet, so I think it's not the right time to dilute the capital of the company.

Speaking of shareprice, it has drifted lower again. The Enterprise Value of BOTA is under well 60 million.

Saturday 12 October 2013

Paddling around, waiting for the dilution wave

So, all is in readiness for a 70 million capital raise.

It's pretty clear nothing will happen on the market until this is clarified. The SP has dropped to $4, and will sit there until the details are announced.

We'll see how sweet a deal is offered in return for liquidity. But, as I've mentioned, there are few champions left for Australian shareholders on this Board.





Monday 30 September 2013

Annual report

The annual report is out and makes for comprehensive reading. Nasdaq listing has that in its favour, even if some of the disclosures are a little formulaic. However, an analyst reading that annual report would have a fairly comprehensive background briefing.

A few features worth considering.

1. Biota will look to partner its HRV (vapendivir); gyrase antibiotic; and remanant Hep B compounds. Only gyrase has any potential, I think.

2. In my view, they will use a in-license purchase to achieve two goals: buy some income; and (of more relevance) raise capital to make that purchase thereby introducing more institutions onto the register and presumably more "liquidity" into the market. Whether they offer current small shareholders an opportunity to engage in that capital raise and at what price is unknown. Dilution will occur. Mr. Fox assured us that a capital raising wasn't required before the merger, but that assurance will probably go the way of other missteps in this process. The SP will probably drop again.

3. LANI patent on the chemical structure only runs to 2017. The combined entity (active drug and inhaler) has a patent till 2021. The possibility of patent extension is discussed at length and so it should, because the lack of haste in bringing this compound to market was suboptimal. That might extend the patent by another few years. Interestingly the patent on the inhaler (hovione) runs to 2029. The rest of the compounds aren't that relevant, because I doubt they will find a buyer for any of them apart from maybe Gyrase which has patent coverage to 2027.

4. The share price performance relative to Nasdaq biotech is absolutely terrible.

5. Everyone ripped cash out of NABI before the merger: its shareholders and certainly its executive officers. All paid for by Biota shareholders, at great cost.

6. There are 44 million dollars in tax credits in Australia and 23 million in UK. I am not an accountant, but that's 67 million in value gifted by Australian shareholders into the merger. It's not clear how that can be monetised. Biota should have found a way to pass that benefit to Australian shareholders before the merger. If those credits are lost, it represents further incompetence around the merger.

It's also interesting that Mr Plumb and Mr Patti didn't receive their whole bonus entitlements because they didn't achieve all their targets. In other words, they were actually set some stretch targets prospectively and judged against them. This is very unusual for we Australian shareholders, because our executives are much better  - they seem to achieve all their targets every year. Wow.

The agenda items will inevitably pass.
I was interested in the comments regarding the position of Chairman. The justification for separating the CEO and Chairman positions sounded a bit strained.

The institutions will update their holdings today, so we'll see what if any interest has occurred over the last 3 months.

In Japan, the government has passed legislation allowing the establishment of individual investment accounts where 10,000 dollar per annum per person can be invested in risk assets (i.e stocks mostly) which will be income and capital gains tax exempt for 5 years. The law will run for 5 years. Commentators suggest a surge in the otherwise dormant Japanese market. Again, I wonder if DS will find the capacity to raise capital easily and buy some businesses. Like BOTA.

Speak again soon

Wednesday 18 September 2013

Yawn, and not just because it's late

the annual results announcement and associated webcast went off with a whimper.

Let's work backwards.

Only two analysts asked questions: Guggenheim and Bioscience Managers. I think Bioscience are newish to the Biota register. But only two analysts was a bit embarrassing.

And the questions were hardly incisive. One about the risk to the trial of a slow flu season, the other about currency hedging strategies.

The Q&A session at the Melbourne shareholder update a couple of months ago was far better. The critical issue of DS royalties wasn't addressed by the analysts and it remains the single most important corporate issue facing the executive. It was addressed at the Melbourne meeting.

As for the results, there has been some deck clearing. Lots of options and shares issued (to old and new management) resulted in significant increases in general administrative expenses, and hopefully these won;t be there next FY.

The cash balance at the end of the 2014 year will be less than originally projected: around 57-62 million. Severance has affected that figure, along with Aussie dollar changes.

Clinical programs

Vapendavir will now be partnered or co-developed. All the reasons Patti raised for not proceeding with VAP were entirely predictable prior to spending 20 million on the Phase 2b:

1. HRV only causes 30% of common cold events
2. There is no simple fast POC (point of care) test for HRV so you have to enrol lots more people than are eventually included in studies.
3. That means studies have to be very large. Also means that without such a test, doctors won't use the drug.
4. As a result of 1-3, registration path extremely difficult.

In the final analysis, the decision to pursue VAP Phase 2b trial was as bad ( but slightly less expensive) as the decision to not settle litigation with GSK.

If there is no partner, it will be quietly shelved forever.

RSV

They are pursing a couple of other fusion inhibitors. They will identify a couple of lead compounds and then start preclinical work including animal and in vitro toxicology. Very very early stuff. Probably designed to just keep a couple of their better scientists in the company for a bit longer, because there is no other science happening.

No mention of gyrase tonight.

So, 2 programs (not sure if that includes VAP) other than LANI Phase 3 trials. Phase 1 LANI in children and asthmatics. Major board changes. Cash burnt a bit faster than expected.

Not sure how much visibility has increased.

Good night




Monday 16 September 2013

Viropharma probably not a buyer of BOTA anymore...

...because it's in play.

A possible trade sale to Sanofi or Shire has been raised in "confidential" talks. Obviously Goldman Sachs want as many potential bidders to know about the unsolicited approach.

The shares have risen 28% in response.

There seems to be a little excitement/cash in the biotech/pharma market at the moment. Or is that just my wishful thinking?

Meanwhile DS are having problems with its Indian generic company Ranbaxy, who keep running foul of FDA on its manufacturing standards.

Not like the nice clean factory BOTA has.


Friday 13 September 2013

Peter Cook resigns from Biota Board

Peter Cook is no longer associated with Biota except as a major personal shareholder and option holder.

His resignation from the Board was announced today.

Having an immediate ex- CEO on the Board was unusual, unless he's the owner of the company.

Mr Cook also didn't have a biotech background (apart from Biota). It's possible this was a transitional Board appointment, but my guess is it wasn't designed that way.

The Board now retains Jim Fox and Richard Hill as the sole Australian shareholders. In fact, Mr Hill (who represents Hunter Hall) is American. In essence Jim Fox is the sole representative of unaligned Australian shareholders on the Board. However, the past Board was full of Australians and they cared very little for the benefit of small, non-executive shareholders.

The vestiges of its past are being lopped back hard. We'll see from the annual report how far the total Australian operation has been pruned back.

After the pruning, we'll look for regrowth.

Wednesday 11 September 2013

Full year results next week

September 18, with a conference call.

Not much action on the share price, although volumes consistently a little higher.

It will be interesting to see if any analysts attend the conference call.

Tuesday 27 August 2013

Business case for Daiichi

Many people tell me the Japanese do business differently. Often those same people can't exactly explain why they do things the way they do, other than culture.

I can't explain why DS wouldn't have bought out Biota by now.

DS co-own LANI. They completed the clinical trials to registration and then marketed it themselves in Japan. It makes them money: maybe not a fortune, but a good revenue stream. They know the margins.

Interest rates are zero and the yen is flowing freely from the printing presses.

DS have a presence in the United States.

Biota currently holds the financial capacity to complete clinical trials in the US, and is looking to market it themselves. Biota will be coming to DS to settle a royalty deal.

And Biota have an enterprise value of about 50 million. 50. Maybe 2 bucks a share.

Why wouldn't DS buy Biota and get on with marketing the compound themselves in the US?

Why would they settle on a 10% royalty? Why would they agree to any royalty deal when for a relatively miniscule amount they get a funded and established clinical trial program for a drug they know well, a manufacturing agreement for compound and device, and a revenue stream in 3 years? They must know the company still has little profile in the market and the Aussie investors will probably take a cheque if it's reasonable.

This is a compelling business case.

At 10 per share it would cost them barely 300 million.

At 10 per share, they get 70 million in cash and the balance of 230 million grant (with a 7% administration margin). And at 10 they could claim they are paying over 100% premium to market.

And most importantly, I don't know if there would be any other buyers in the market, so no auction.

For us, 10 per share is still less than the amount the ASX listed Biota reached on the day it announced it had won the BARDA grant for LANI. Those long toothed Biota holders wouldn't see it as a win.

But that's not my point here - my point is about DS.








Saturday 17 August 2013

More Board changes

Dr Errington has resigned from the BOTA Board.

He's been replaced by a local (to Georgia) medical venture capitalist, Dr. John Richard, who's been nominated as independent.

The Board changes are interesting, but opaque to outsiders. It might have been reasonable to presume that Dr. Errington was East Hill's representative on the Board. Why East Hill would let that position lapse hard to understand, given their ongoing stake.

It's a little hard to see how a seed venture capital company will help with Biota's "liquidity" problems, but this will be revealed soon enough.

Many of you have already mentioned to me privately, and at the Melbourne shareholders' update, that the best option for improving liquidity is to create a healthy demand for the stock. In that case, more buyers from the US and more sellers (some from Australia) will meet each other.

The AGM will be in November, but the release date of the 2013 results is not yet clear.


Thursday 15 August 2013

Liquidity solution: capital raising.

In the end, not very imaginative.

The promised solution to BOTAs liquidity problem is to issue up to 75 million dollars worth of new shares (or warrants, or any other form of security).

At today's prices that's nearly 19 million new shares. Pretty big chunk.

The release to Nasdaq late yesterday outlines the company's plans. All that remains is how much, to whom, and at what price.

The invitation to share in BOTAs future growth, should it ever arrive, is never ending. If BOTA is true to form, the terms struck with the institutions will be to the disadvantage of current and small holders. It only remains to be seen how low the price will be.

Again, you will be able to judge the performance of the current independent non-executive Board members based on this deal. But remember that they don't face a vote.

The most abrasive part of this is that of all the reassurances delivered during the process of moving to Nasdaq, the loudest was that BOTA would be cashed up, and wouldn't need to capital raise. This dilution comes to a still pre-reconstruction battered share price.

Carpetbaggers will return to Georgia.


Thursday 8 August 2013

Trius

When I was at the 2012 ICAAC in San Francisco last year, Trius Pharmaceuticals had extensive presentations on their two antibiotics.

The main interest for me was that they had a Gyrase program, similar to Biota's, and they were working very hard on it based on the presentation posters. I couldn't find another gyrase program presented.


Well, Trius looks like it will be sold to Cubist for at least 13.50 a share valuing the company at about 600 million. Which is about 4 times what it was worth a year ago when I was looking at their posters. It has about the same cash in the bank as BOTA, but is spending a lot more on its clinical Phase trials. Their gyrase is in Phase 1.

Their main antibiotic is tedizolid, which is a gram positive antibiotic with MRSA coverage. Its completed some Phase 3 trials in skin infections and they are extending its clinical scope.

I think the BOTA gyrase program might be worth something.

While a swallow doesn't make it spring, there have been a couple of them in the uplift in the share price of late.





Tuesday 30 July 2013

Melbourne Biota Shareholders Briefing 30/7

This was worth attending.

Firstly the slides and the accompanying opening commentary were identical to those presented to the JMP securities meeting. You can view them on the BOTA site. There was little in the formal presentation of note.

Also, you need to note that I'm simply recollecting and interpreting the meeting.  Those safe harbour statements apply here too.

There was some initial verbal angst directed at the absent Chairman around the organisation of the NABI reverse merger and the subsequent halving of shareholder value in the process.  Russ Plumb took it on the chin. Actually, he refused to accept the invitation to apologise on the Chairman's behalf : "Give it a year".

Here are the highlights

LANI

ROW Phase 2 LANI trial results in due in a year: top line results in late June/early July 2014, probably announced a bit after that.

Start Phase 3 depends on FDA reviews through late 2014, but Phase 3 could go through to 2015-16.

LANI patent extends to 2024. Delivery device patent a little longer. They seemed unconcerned about the 7-8 years of patent life due to the requirements of generics to provide combination of delivery device and drug.

HOWEVER they have had significant discussions with DS about the ROW rights. There were two important facts revealed:

1. That they are aiming for 80-90 BOTA v 20-10 DS revenue split.
2. They are aiming for a deal that can be announced before or around the time of the Phase 2 results

This essentially supports my long held view: there is no way to assess the value of the company if the revenue split is not made clear to the market. I was convinced that they were finally engaged in delivering this important outcome.

In a year, the best outcome would be a successful Phase 2 clinical trial result, the announcement of the revenue split, and a rating of the company.

There is a long way to go to that happy day: DS have to come to the party; the trial results have to be good. The market for antivirals needs to be stable enough to assess (and although it wasn't mentioned, generic tamiflu may play a role there).

Its also possible that after Phase 3 they will keep the stockpile rights and monetize the seasonal drug with a deal, rather than employ a sales team and sell into the US market.

VAPENDAVIR

Vap is an effective antiviral.

However the management team feel that the impact of the outcomes shown in the Phase 2 trial will not result in a reimbursable product i.e no-one will pay enough for the drug to justify the expenditure in further trials and marketing. The overall benefit just wasn't strong enough. Also the need to assess whether HRV was the cause of the symptoms was too onerous, and if not the % of people with symptoms who have HRV is not high enough.

They are looking toward alternative applications and these are both hospital based (and possibly IV although we didn't specifically ask them that):

1. Severe HRV caused asthma exacerbations requiring hospital admissions
2. Viral meningitis (for which there are no current treatments, and this is often caused by enteroviruses against which Vap is active)

They are considering spending a modest amount (8 millionish) on Phase 2 trials in either of these areas. Maybe.


SHARE PERFORMANCE


They have faith in their capacity. Their Inhibitex legacy has bought them the ability to meet most US institutions who still feel warmly toward them.

They believe that institutions will support their vision for the company, especially once there is news to announce. The overseas experience of LANI and US fully funded trial components are uncommon in biopharmaceuticals.

But liquidity is a problem. Essentially, institutions can't get enough shares on market without severe distortions. There are few shares traded and tradeable.

Why?

Because 60% of the shares are still owned by 10,000 Australian shareholders who can't, or won't trade their shares on Nasdaq. A massive overhang. The only people US institutions can buy from are essentially other US institutions. Or Hunter Hall I guess.

Something that was entirely predictable from the outset.

So the company is looking at liquidity.

The obvious answer was put to them - dual listing. It was categorically ruled out. The reason: none, just ruled out.

The other obvious answer is for the share price to increase enough to shake some Ozbiotans to sell. But its chicken and egg: share price won't move unless institutions buy, and institutions won't buy if there aren't big parcels on sale.

The Board are actively considering other avenues. What other avenues are there to consider? They didn't specify, just that the Board was actively considering this issue.

My fear? And this is without any foundation at today's meeting, just my speculation: that we have been primed about the purchase of a revenue generating program. So, BOTA buys a program and raises capital from US funds at any old share price to increase liquidity. Diluting small Australian shareholders. Again.

We know that 70 million cash is a nice buffer, but won't buy much of anything. But yet even today, we are still told we don't need to raise capital.

I hope I am wrong. In which case, the experts can help me: what other strategies are there to increase liquidity?

In summary, it was a good meeting. Mr. Patti seems a tough negotiator. They both appeared genuine and knowledgeable. If a fund got that briefing they would feel pretty confident about the company's prospects.

I did, despite the pitfalls laid out clearly in front of me.

If I remember anything else I'll post it. If you were there and you disagree, post it as a comment.


Friday 26 July 2013

Hunter Hall sells down; Australian shareholder meetings

That didn't take long: Hunter Hall have sold down a substantial part of their Biota holding.

They are down to 2 million shares or just on 7% of the company.

My very rough reckoning says that they took  substantial loss on those shares.

However, it's still difficult to know what it means. In the face of a (announced) significant redemption on their funds they have been sellers of several stocks. Nevertheless, it was a big sell down.

Other issues:

What does it mean for their board representation: 7% is now hardly a key holding.

Who bought their stock? We won;t know unless it becomes a substantial holding although it looks like anything over 1% is reported in the US.


The CEO is coming to Australia. That's pleasing and he should be welcomed.

Many of us have been to these local presentations in the past. They shared very little and hardly engaged shareholders. And if we looked at the content we'd discover just how little of those presentations have subsequently resulted in anything positive for the company.

Still, nothing worse than a near empty seminar room. You can understand the message that sends to the executive team.

If you can't make it, let me know your question and I'll raise it.

And if you have time, we may get together afterwards to acquaint ourselves over a coffee nearby.


Saturday 20 July 2013

Ownership matters; and Short Game vs Long Game

There was a significant cross of 1 million shares this week, and a slight momentum in the share price followed. My bonehead analysis is that market insiders knew who the buyer was and were pleased. If not, the fact a current holder was selling a million would have caused the price to drift south. There have been 2 significant share crosses in the last weeks.

But I see no new notices regarding ownership. So, while I'm waiting, I thought I'd quickly summarise the current ownership profile to the best of my knowledge.

Hunter Hall owns 3,267,905 (11.6%)
Landon Clay and East Hill own about the same (11.3%)

For some reason neither appear in the institutional ownership summary in nasdaq

Nasdaq reports the remaining institutional holdings owning 10% between them: these include Dimensional, 683 Capital, Gabelli, Rennaisance, and Towerview in the top 5. Aside from Dimensional who have sold a few, the rest have been steady holders.

That puts significant institutional holdings at about 34%.

Problem is that almost all of those institutions hold shares as a result of their holding in the pre-merger entities: HH and East Hill in Biota, the rest in Nabi. And, if we're being accurate, East Hill came on the register via Biota's purchase of their gyrase program, although they did buy more Biota afterwards.

I guess the other issue is that these funds haven't been in the market at sub-3.50 either.

Let's wait and see who's either joined us, or left us, in the last few weeks.


LONG GAME VS SHORT GAME

Hunter Hall and East Hill have played the long game and lost. They continue to play the long game. Like most of the rest of us. But as Galbraith said "In the long run, we're all dead". Even if BOTA comes good, as we hope it does, the sunk opportunity costs have been tremendous.

If the short game is buying programs, it will be more of the same: Biota keeps buying assets that lose cash, generate no value, while the long game on influenza gets further away. Starting their Phase 2 last winter, rather than this winter, would have made a tremendous difference to the LANI program.

What Biota haven't been able to do is play the short game: sell programs or sell deals to develop their programs. That's the short game that gets investors excited and gets share prices moving. They bought the gram positive program and it's dead. They couldn't or wouldn't sell their Hep C program when it might have been worth something in the midst of the Hep C gold rush 2 or 3 years ago. They let go of influenza rapid diagnostics long ago, when that would have now been an excellent cash earning adjunct to their long game.

They have the following assets to sell while playing the long game:

Gyrase/gram negative
Rhinovirus
RSV

They should sell these programs or deal these programs, while we sit in LANI's waiting room.

And the other great short game strategy: do the Rest of World deal on LANI. Announce it. Then we can wait with some certainty about the outcome, and the analysts can do their sums on incomes.






Saturday 13 July 2013

The Voice

We all got to hear the first words from the CEO of Biota during the presentation to JMP Securities' health conference early Thursday morning. It was a relief to finally hear the crackle of etalk about our company. Go to the company site and listen. I had trouble opening it, but clicking on the adobe flash option at the bottom finally worked for me.

A few thoughts.

He sounded a bit nervous, which I wasn't expecting.

To "old" shareholders there was very little new in the presentation. In fact, very little has changed in 2 years. That's not encouraging, but is to be expected when the executives have 70 million in the bank. Where's the rush, huh?

He did talk about the seasonal influenza market, something Mr Cook (the previous CEO) rarely did. Cook felt that a stockpile order every 10 years would be somehow enough. 

He mentioned reducing cash burn to 5 million per annum, with a later goal of royalties matching expenditures. That was great news, but since royalties are lumpy, it's tough to call. The 7% margin on the BARDA contract is constant however: theoretically that's 16 million over 5 years. Nevertheless it's the first time cost control has been a focus for the executives, who liked to spend. Which is why we're in Nasdaq. Which if they didn't spend so much on the ASX, ah, chasing my tail gives me a view of my backside.

While we're on BARDA there was lots of interest in BARDA procurement and in BARDA fast tracking approval. Ultimately it's the FDA who calls those shots, and even in the case of an emergency, FDA would still be the arbiter in my view. These issues aren't worthy of including in any analysis.

Sadly, the earliest Phase 3 trials can start is the northern winter of 2015. We will hear about the Phase 2 in about a year's time. Time flies when you're on a patent clock and the disease comes around but once a year. I don't actually understand why, if Australia, Sth Africa and Sth America are all legitimate places to conduct clinical trials for the FDA, that the extensive Japanese clinical program is excluded?

Mr. Plumb spoke about looking to buy in other clinical assets, presumably ones that are in, or close to, market. But good assets are expensive, BOTA has only 60 million to spend, and the share price is too terrible to contemplate a raising.

Vapendavir is stalled while they look at other target risk markets. Which ones? Post transplant? Different diseases other than asthma?

He's right about oral versions of relenza: developers will need a complete and new clinical trials program because approvals are for the inhaled product. It will cost hundreds of millions to get approval for a molecule that is essentially generic. And you would be nuts to make a diskhaler with relenza in it. Glaxo were.

One last little point: early in the presentation he introduced the company as having a licence to develop LANI in non-Japan markets.

Um, I'm not sure that's strictly correct. BOTA are the co-owners of laninimavir with Daiichi Sankyo. There is no licence for non-Japan yet, as I understand it. And that leads me to the questions that weren't asked...

And there were plenty. This was a greenfield audience. The questions were fairly weak, and seemed to come mostly from the same one or two people. I got pretty irritated that it took so long to point out  that Phase 3 was already paid for by BARDA. They nearly didn't!

Nothing about the BOTA royalty split with DS in non-Japan.

Nothing about doing research in Australia and business in the US.

And not much for current shareholders. The US move has resulted in no other business development (obvious to the outside) for 2 years.

June 30 accounts should be out soon. There seemed nothing on the horizon that would create any value.

The analysts know that it's a 100 million dollar company with 70 million in the bank losing 5 million a year.

What did you think?



Wednesday 3 July 2013

Who's selling

An inordinate (well, about 200,000) number of shares crossed on June 28 at 3.40ish. Interesting activity over the last week to take the price down to $3 before this deal was crossed.

I've been waiting for a change in substantial holder statement to come out.

Nothing yet, but it will be interesting to see.

As you all know we shall get to see the CEO present the company to institutional investors and analysts on July 10.

We should all keep a little eye on Viropharma: watch for their announcements, any shift in strategy. I note they are presenting at the same meeting as BOTA but then they present at many such meetings. See what they have to say. BOTA has a lot of cash, just sitting there, no debt and a nice grant for 3 more years. VPHM are down to 90 million free cash (ex repayment of notes), have stopped their share buyback, and might be looking for an acquisition. Antiflu is not really the kind of disease they now concentrate on, but they have looked at anti-rhinovirus with pleconaril in the past. And they are now on the Board.





Tuesday 25 June 2013

Ozbiotans

Apologies for the delay, but the truth is there has been little to report.

In fact, nothing to report is the theme for this post.

So far, this influenza season has been very slow. This should have been expected after last year's severe season, both here and in the northern hemisphere. This means that the recently reported commencement to LANI trials have picked the wrong year. My general guess, and there's no science to this, is that the severity of the epidemic not only affects numbers of infected people, but the severity of individual cases might also be affected. This is important in the context of the outcomes of the clinical studies: LANI will show the most improvement over placebo where the disease is at its most severe. In my view, the use of neuraminidase inhibitors is at its most effective in, or just before, ICU.

By the way, what ever happened to randomised trials of neuraminidase inhibitors in patients admitted to ICU with influenza? In all likelihood it's probably an unethical study now, but it would be worthwhile addition to the evidence for NI.

So, likely less Inavir sales next winter from Japan.

Nothing to report from the company either. Commencing LANI trials is a meaningless release. Not commencing them would be news.

No news is good news? No, it isn't. The market has been savage to BOTA: it is now at it's lows, with little support. Again BOTA didn't benefit from the general uplift in stocks through Jan-May, but fell when the Nasdaq fell.

The big problem is that it starts to become what it looks like: an underpriced cashbox with a single lucrative grant for a single marketable product.

I treat my contacts with other shareholders in strict confidence. However, I think I can make an exception for non-contact. So, my recent effort to discuss Ozbiota and our company with Hunter Hall has failed to generate a response. Hunter Hall have bigger problems with a very large redemption of funds (8%) called on them. This might put some selling pressure on their stocks, although they would be taking big losses on BOTA of they tried unloading on (or off) market right now.


The point I made to them? What impressed me with the activism by NABI institutional shareholders around the reverse merger was that what was good for the big shareholders was good for small shareholders. If a big holder thinks it can make gains at the expense of their smaller holders, they can - but it shrinks the pie for everyone. Institutions will do best when they do the right thing for all shareholders.

So, let's wait for the EOFY statements. Or any other statements. Or occasional signs of life.

If you know any other BOTA shareholders, ask them to email me at: ozbiotaATgmail.com- join up.

Regards


Saturday 8 June 2013

The A$ helps our cause

Well, Ozbiotans, the only news to report is that there has been a lift in value for Australian shareholders of BOTA. The exchange rate of about 1.02 was used in the merger, and we are back at 0.96. The devaluation of the A$ has helped the valuation significantly over the last 2 weeks, and there may be a little more to come.

Although I voted against the takeover, I thought the exchange rate play was the only advantage, and Jim Fox made that point at the oddly uncontrolled last EGM. 

But, in the end it was a frankly crazy way to get exposure to a forex play. 

In the unlikely event that the Aussie dollar sinks to 50 cents US, we need another strategy. The SP is struggling at historic lows.

AAGM

The number of shares linked to Ozbiota is now well above 1%.

My intention is to hold an AAGM (Australian Alternative General Meeting) after the end year results are announced in July or early August. It will be in Melbourne. By then we should have the results, and a little more news to digest.

Between the results and the meeting I'll write to the Chairman, requesting a discussion regarding the company. 

I'll also invite along some Biota experts to the AAGM meeting to help broaden the discussions. But the meeting will rely on your participation. I know that's not why most people buy shares, but for all the reasons outlined before, it helps all of us who are long BOTA to act outside the square.

Valuation of the Company

With the strategic review done, the valuation on the company has fewer components. 

Hep C, and the gram positive program, are both valued to zero.

Relenza is dead and should be valued at zero.

Vapendavir has a significant cloud over it, and probably needs to be valued at zero for now.

The ex NABI compounds have no discernible value.


That leaves: GYRASE (gram negative program); RSV (but a new lead candidate); and LANI ROW and INAVIR in Japan. 

The gyrase progam has some legs and hopefully will produce a deal. But valuation is difficult.

The patent life left on INAVIR is maybe 8-10 years, so possibly a $20 million valuation would be reasonable.

Again, it highlights the importance of a ROW deal for LANI. The market (and we) get some idea of the value of our company. The combination of seasonal and stockpile sales could reach 50% of tamiflu's market. While that's a fair assumption, it's difficult to assume that BOTA will earn 96% of that share of the income. Margins can be calculated then.

Without that royalty figure, the valuation is open to violent after shocks. 

And I think that's why the market is avoiding it.





Thursday 30 May 2013

I'm proud to announce that Ozbiota has now gained the allegiance of 1% of the total shares on issue of BOTA.

Thank you for taking the time and effort. It is amazing to read how much in common you have with each other.

Should I call the SEC?

Get the message out there and let's recruit to the aim of 1 million shares, which is over 3% of the company.

I intend to invite members to a dinner meeting in the near future. It will be in Melbourne, and I hope most of you can make it.

Neuraminidase inhibitor treatment of influenza is one of our country's greatest scientific inventions. It's impact is greater than the cochlear implant or the HPV vaccine: two wonderful inventions that have created health benefits yet those two inventions have also generated significant returns for the shareholders who invested capital to create, test and market them.  

I think that's at the hub of small Australian shareholders' anger and frustration in BOTA.






Wednesday 29 May 2013

So, in order to focus on company communication, or lack of it, lets devise a list: the top ten questions we'd like answered by Biota management. Here's 9 to start:

1. Vapendavir has had over 20 million dollars spent on its development. You are still considering its future. Why? What are the issues that you need to clarify to determine the next step? Who is considering those issues? How long will considering those issues take? Have you had any interest in this compound? Why was a Phase 2b trial initiated? How much longer does this compound have on its patent?

2. What are the legacy issues in using Nabi as the vehicle for a reverse takeover and listing vehicle?

3. You are reassembling your team at Inhibitex. We can understand the advantages in doing that, but what are the disadvantages?

4.Why do you have so many Board members?

5. You have a significant number of Australian shareholders. Is that now irrelevant? Does that influence your communication strategy? Will you hold shareholder and analyst meetings in Australia? Is dual listing on the ASX a possibility to assist current and potential shareholders to manage their holdings from Australia?

6. The arrangement with Daiichi Sankyo for Rest of World rights and royalties to lananimavir is opaque, and may be negatively affecting the market's view and valuation of the company. When will this be finalised? Why would the company delay finalising this arrangement given the impact on the company's valuation?

7. It was the previous management's intention to take LANI to market in the ROW. What is your view?

8. There has been no positive reaction from the market to the NASDAQ listing and recent strategic review. The BOTA shareprice is poor, while the US market is reaching new highs. Why? What would be the drivers of shareprice improvement in BOTA? What would US institutional investors seek in a biotech like BOTA before investing?


Sunday 26 May 2013

A brief post: well, we've reached 6 figure support in a relatively short time.

Our new target will be 1 million shares associated with this site.

Thanks for your responses. Over the next couple of posts, we'll go through those and any news that emerges. Responses have alerted me to the initiation of some coverage of Biota by US based analysts, but we need to look at the quality of those firms and not just what they are saying. I can recall many positive analyst research reports in the past, which only hurt the company when the company's actions didn't match what it told the analysts. For example, some analysts were clearly expecting a ROW lananinavir deal many years ago.

Ozbiotans are happy for an outlet for their ideas and frustrations. In fact, the lack of communication and transparency from this company ranks highly among the issues raised with me so we'll make that a priority. Other issues are the plentiful.

I'll also allow comments on the site as a trial: please keep it clean, legal and identifiable. If it works, it stays.

The share price has seen some significant selling pressure with volumes on certain days over the week, with recovery on smaller volumes.


Tuesday 21 May 2013

Welcome.

This site is intended for Australian based shareholders of Biota Pharmaceuticals. Biota was an Australian based company for 20 years until it delisted from the ASX in November 2012 to list on Nasdaq through a reverse takeover of a cashbox shell company called Nabi Biopharmaceuticals.

Biota is now based in Atlanta, Georgia.

But most of Biota's shareholders are Australian, and most are small holders.

This site is to encourage those shareholders to form a network to exchange information and ideas.

Well, partly. It is also intended to allow shareholders to unite as a proxy voting block to gain better representation and influence.

Biota has a great Australian invention but a terrible corporate track record. In its move to the United States, its shareprice was ravaged by Nabi shareholders and by traders. The result is a company with a capitalisation little more than its cash in the bank. The company has ignored its shareholders, primarily because it can.

The destruction in capital wealth has occurred with the apparent co-operation of the 2 large shareholders who are represented on the Board. They have not been able or willing to reverse this shareholder wealth reduction even though it would seem to be in their interests to do so.

Further to its strategic review, the Board has changed 2 directors, and both new directors are US based executives. From all appearances, the new CEO has recruited his old Inhibitex team. Nothing that has occurred since the announcement of the move to the US has improved the situation for shareholders.

This leaves the average small Australian shareholder further distant from the aims, performance and outcomes of the company.

So, what to do. I have some form to disclose.

In 2008 following Biota's withdrawal from litigation against GSK, foregoing a 100 million prior offer of settlement, I ran as an independent for the Board in protest at the actions of the company.

In the course of that episode, the then Chairman wrote to shareholders informing them that undirected Chairman proxies would be voted in favour of my election. 3 days prior to the AGM, he announced to the ASX that he was reversing his direction to vote against me. This gave the average shareholder little chance to change their vote.

The action spoke to the qualities of the then Chairman and some members of the Board, and offered a glimpse into the kind of people running the company, and for whom it was run.

I lost : 6 million votes weren't enough.The Chairman and another Director left soon after.

In general, shareholder activism is frowned upon: it seems to be more acceptable to quietly lose to a group of strangers. And we all have day jobs. But, the situation of the Biota shareholder is a little different.

I would like to encourage you to join this group and think about contributing your shareholding to a voting block.

Where this goes depends on the response. Perhaps the best we'll do is meet now and then. Perhaps we'll hold 10% of the company.

The email address dedicated to this site is

ozbiotaATgmail.com

Maybe we should start with examining a position on:

dual listing
the number of Board members

Regards 

Michael Montalto