Thursday 15 May 2014

Saturday 10 May 2014

Not So Fantastic, Mr Fox

3 years ago BOTA could have negotiated a ROW deal, or an outright sale of the company, with big pharma from a position of strength i.e the LANI compound and 230 million to throw into the bargain. That partnership would be much further along because a large organisation could move more rapidly with trials and it wouldn't have wasted a year moving stock exchanges. If BARDA had pulled funding from Daiicihi Sankyo, what impact would that have had on BOTA? Zip. The Board thought that 80% of the return for 100% of the risk seemed a good deal with the BARDA grant. But the risk calculation was wrong. BOTA's a Cessna not a Jumbo. Losing an engine, no matter how improbable, has different effects.
 
BOTA will now be negotiating with medium pharma from a position of weakness: no ability to fund and a ticking patent clock. Cap in hand. LANI must go to Phase 3 by Southern Hemisphere 2015 as planned. I know it, and any potential partner knows it. 80 million in the bank doesn't help in that context.

Phase 2 should be positive, but the results are 2 months away. Selling with Phase 2 is (a bit) better than nothing.

But if the BARDA termination has to do with a negative attitude toward NIs from FDA it's bad news from a partnering point of view. The 'best' we can hope for is that they thought the company was mishandling the grant.

BOTAs recent capital raising introduced fund managers that, after the reasons for termination are released, aren't likely to back BOTA now for full funding of Phase 3. Trying would be nuts.

The Board is meant to assist the company as well connected experts. None had any inkling of a change of heart at BARDA. And none could do anything about it. They need to do some work now.
Disparate and small Australian shareholders are easy to push around. Burning US hedge funds' cash is a little harder to hide. The Board needs to express something other than surprise.

Sadly, the only option appears to be to sell or merge the company's assets, even though those enterprise assets are currently valued at almost nothing. Only hubris can get in the way.

This is a failure to commercialise an excellent drug. It's a painful irony in the face of so many examples of successful commercialisation of worthless or dangerous drugs.

Barda was the only upside surprise this company ever delivered. It now joins the rest of the wrecks on the downside surprises.


Other notes

Barda were the ones who sought testing for an 80mg dosage - there was no need to introduce that into the clinical trial mix. Testing only 40mg would have meant an adequate number in the current Phase 2 trial.

Barda's explanation for the termination will make compelling reading.

Wednesday 7 May 2014

It's deja vu all over again

Well we've been here before so many times that it seems weirdly familiar.

BOTA back to (basically a little above) cash backing. Back to immediately pre-Nasdaq ASX dumping and shorting lows.

There might even be a few of you out there who experienced the FDA antiviral subcommittee's rejection of Relenza last century. Now that was also unexpected and the market reaction was...like re-entry into the atmosphere without the little parachute at the end. Or the water.

 Maybe this time through no fault of it's own.

Today's quarterly results and conference call were useful. Clear statements that BARDA had been kept abreast of all developments with the LANI contract as they arose, from the beginning. Amazing to learn that the scheduled management input into the IPR involved a single 45 minute presentation. A. Single. 45 minute. Talk.
This should remind you all that powerpoint can kill.

Didn't tell us if the project actually was overbudget. I doubt it. I wondered if the extension of Phase 2 required extra money.

Everything other than BARDA stopping the contract was just dandy. Cash in the bank, courtesy of less spending and more royalties. Other programs chugging along.

Phase 2 results expected out in the next quarter. If they show what's expected, we could have expected a significant SP rise.

My guess is that DS sales of Inavir in March quarter to be released on 15th May will be really good.

That would also have pushed us along.

So would the release of the new shareholders who came on board during the capital raising in January - that's due out next week.

One concern even if BARDA continue their support is that it's not clear whether any trials can get underway this Northern winter.

No word on the DS ROW negotiations.

But on that, I scratch my head. Why would DS not ignore any deal, throw in an unsolicited offer for the company and replicate its Japan earnings in the US? BOTA's valuation is just criminally low right now. Considering how DS were monumentally #%&@ed by Ranbaxy, this would be both chickenfeed and a great value adding buy.

So, we wait for others to decide our fate. That's always the case with biotech to some extent, but this is extreme.

As you all know, I would have sold the ROW rights with the BARDA cash 3 years ago. Too late for that. Let's see what BARDA/FDA dream up. Might be this week, might not be.

I hope this the price that one day the press will write about: that the stock was $3 in 2014 after the BARDA stop order, before the company was sold for ??? at that magical time in the future.