Replies to post #525 on Javelin Pharmaceuticals Inc (JAV)

[gabewhatley]

JAV is no longer a develop stage biotech, as of yesterday. they have plenty of cash. So I guess they're going to let the shorts short it back to $3.50. if you're public company, and you don't care about the stock price, there's no reason to be public

[dewophile]

speaking of cash
one analyst asked about the burn moving forward. JAV estimates that it will be about double by the end of 2008 which may have some analysts and investors concerned. otherwise I'm stupefied by the selloff today, despite what's going on in the macro market

for those who say there is no news flow to stem the bleeding, here's my outline for the next 6 months with some admittedly biased commentary:

Dyloject:

1. Launch in UK q1'08
2. Results of first ph 3 in US (could be big news if better clinical profile to toradol on bleeding (which is expected), and/or on efficacy (faster onset and at least equal efficacy/opioid sparing)) Q1'08
3. EU partnership for Dyloject (ex UK and Germany) 1H'08?
4. Complete enrollment second US ph 3 1H '08
5. Approval in Germany 1H '08
6. Initial sales for Dyloject (which in absolute terms will be small, but as a % of market share at particular hospitals where on formulary could be a true indicator of physican acceptance and future market potential) 1H '08

Currently diclofenac sells 100M in the EU, and has a 60% market share. NSAIDs are clearly superior in efficacy to IV acetaminophen, and Ketorolac is off the EU market. The company’s guidance assumes 30% market share at higher price point. This could be conservative – why would anyone still prescribe voltarol once diclofenac is on formulary – same drug, faster onset of action, same duration, and perhaps even a net savings to the system in terms of cost

Ketamine:

1. Outcome of pre-NDA meeting ( I am amazed a looming, low-risk approval in 1H ’09 for a conservative 100M annual revenue generator with promising potential for further expansion in larger markets through sNDAs doesn’t alone justify current share price) q4 '07
2. Release pK labeling studies 1H '08?
3. Complete enrollment first CA breakthrough study Q1 '08
4. Begin assembling commercial infrastructure in US and/or partnering the drug 1H '08

Rylomine:

1. announcing start of a second ph 3?
2. Clarity on development path in US and/or EU?

The wild card will be some buyout offer from a company with either a hospital presence or niche in the pain market

Valuation comparator:

CADX – 405M market cap largely based on late stage in-licensed IV acetaminophen program (without EU rights). Not as potent as NSAIDs, but will address a parenteral need for those with mild pain (a space in which dyloject can also compete), or for those patients intolerant or for whom NSAIDs are contraindicated (for acute hospital setting with limited dosing this does not represent a large subset of patients). Their second product in development is a topical antimicrobial that has relatively little value