When Biotechs Run Out of Cash… Or Go At-Risk (ISTA, VNDA)

July 29, 2008 · Filed Under General · Comments Off 

Investors are in love with biotechs right now and it is hard to argue against it with the attractive pipelines that can be purchased.  Throw in a cheap US Dollar that allows foreign buyers to buy at a 25% to 35% discount, and the argument grows even stronger.

But there are many biotech zombies that have imploded to nothing but cash, a few employees, and a hope and prayer to find the next drug candidate being shopped around on the cheap.  There is a second group second group of troubled biotechs that have product candidates but are on the race to zero cash.

Enter, Ista Pharmaceuticals (NASDAQ: ISTA)…

ISTA Pharmaceuticals stock is down almost 14% today after the company shares were downgraded at Jefferies with a new UNDERPERFORM rating.  Jefferies is growing more and more concerned that ISTA is on a path that will make it run out of cash by early-2009.  The research note also notes that the holders of $40 million in convertible debt may use their rights to PUT the securities back to the company.  That would only chew up more liquidity.

ISTA isn’t a biotech zombie though.  The company has two product candidates in teh development pipeline.  In fact, Jefferies believes these could make the company attractive to a more speculative buyer.  This would likely generate higher shareholder returns rather than investing in this for looking at an independent company.

Unfortunately, the liabilities at the end of last quarter were $73.561 million versus total assets of $60.03 million (with only about $35 million available in raw cash and equivalents).  Some companies go zombie and trade at a discount to cash prices because of the cash burn rates that will take it under book value.

Vanda Pharmaceuticals (NASDAQ: VNDA) yesterday imploded to the point that it trades well under its perceived net cash value.  That is because the longer review and extra trials are likely to erode that cash faster than a lotto winner out of the trailer park.

JON OGG
JULY 29, 2008

Biotech Implosion: Vanda Pharmaceuticals (VNDA)

July 28, 2008 · Filed Under fda · Comments Off 

Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) is seeing a major implosion this morning. The company has disclosed that it received a dreaded FDA not-approvable letter on its iloperidone. This was its late-stage schizoprenia candidate as well. The drug candidate is apparently too close to other drugs already on the market and the FDA said more safety data would be required to consider another application.

Vanda shares are down 59% at $1.35, which has gone from the good to the bad to the ugly. Its prior 52-week trading range was $2.70 to $19.62. Its current market cap after the drop is about $36 million. While that is well under its cash levels on the books, it will burn through much cash to fulfill its FDA obligations to proceed.

This one isn’t a biotech zombie yet, but you’d never know it if you just looked at its stock chart.

Jon Ogg
July 28, 2008

Vanda Scores on Insomnia Phase III Trials (VNDA)

June 26, 2008 · Filed Under General · Comments Off 

Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) is seeing shares rise this morning on news that its Phase III data showed Tasimelteon significantly improves sleep in patients with chronic insomnia.  The positive top-line results from a Phase III trial showed that its investigational drug candidate, Tasimelteon, which it calls a novel melatonin agonist, met the primary endpoint of the trial and significantly improved sleep in adult patients with chronic insomnia.   This study also demonstrated that Tasimelteon was well-tolerated and exhibited a safety profile generally similar to placebo.

This was its Phase III, multi-center, placebo-controlled, 4-week trial that evaluated 322 patients with chronic primary insomnia. Patients were randomized to receive either 20 mg or 50 mg of Tasimelteon or placebo over the four weeks.

On Nights 1 and 8 of treatment, mean LPS improved by 45.0 minutes in the 20mg group (p<.001), by 46.4 minutes in the 50mg group (p<.001), and by 28.3 minutes in the placebo group. On Nights 22 and 29 of treatment, mean LPS improved by 49.4 minutes in the 20mg group (p<.001), by 45.1 minutes in the 50mg group (p=.016), and by 33.9 minutes in the placebo group.  Importantly, this effect was also seen acutely on the first night of treatment. Patients in the 20mg and 50mg groups fell asleep 22.9 minutes (p<.001) and 25.9 minutes (p<.001) faster, respectively, than those in the placebo group.

Vanda shares are indicating higher with some 2-hours to the open.  Shares closed at $4.99 and are indicated up at $5.90 in early trading (7:30 AM EST).  Its 52-week trading range is $2.70 to $21.50.  This one also has a substantial short interest so watch for that spring-loaded effect.

Jon Ogg
June 26, 2008