ALXA DD Post ($3.85)…HIGHLIGHTS of JPM Securities Conference on 5/11/10.
I added slides to highlight key points from my notes that the CEO made in his presentation.
Market Outperform w/ $12 price target
-Company is based on the Staccato Technology Broad portfolio. Staccato is an incredible inhalation technology
-Technology mimics intravenous inhalation and has proprietary technology
-All drug goes to the lungs is administered as pure drug -The dose is reliable & consistent (Example: If everyone was given Staccato then everyone would get exactly the same dose) 3 Key Points
-At 2 hours highly statistical significant findings when you compare the FDA regulatory endpoint of placebo to drug at both the 5mg & 10mg dose.
-Designed trials similar to intramuscular Zyprexa and Abilify that were developed
-Same endpoint, same population, and same level of agitation with very strong results.
-Showed 10 minute onset which is faster than injections & oral tablets in both the (bipolar & schizophrenia pts.)
-Long acting drugs so even at 24 hrs you had statistical significance. 10 min onset & 24 hrs duration. FDA Application- Initial indication is submitted to the FDA is for the “rapid treatment of agitation in pts. That have schizophrenia or bipolar disorder.
-2 market segments: Medically Supervised (doctors office, clinical setting, ER, Psychiatric ward where a clinician is around to treat a pt immediately ) and Outpaient Market (speed & predictability of injection w/ portability of an oral tablet)
Unmet Medical Need…first time ever a physician does not have to make a compromised decision. They get speed, predictability, and ease of use. PARTNERSHIP
-In Feb 2010 they formed a collaborative partnership with Biovail (BVF..NYSE) for marketing rights to AZ-004 in the U.S. & Canada. They received a 40mill upfront payment. The partnership is strong.
-ALXA is charged with clinical regulatory. The NDA approval (done) and moving into outpt setting. In charge of manufacturing. They can currently make 7 mill units/year in their Mountain View, CA, facility
-Biovail is charged with everything on the commercial side. Preparing for launch, building a sales force, marketing organization, reimbursement, pricing, and medical education (also in the future when Staccato is used for other pt populations like Alzheimer’s or Parkinson’s)
-40 mill upfront payment and 90 million additional milestones with a tiered double digit royalty based on top-line sales. 2010 MILESTONES
-Completed NDA submission. They filed one quarter ahead of schedule (Dec 09) and notified of PDUFA in Feb 2010
-Finalized a commercial strategy with Biovail. Locked down U.S. and Canada markets.
-Ongoing discussions with potential partners outside the U.S.
-PDUFA date is October 11th and Launch date is late 1st Qrtr of 2011
-Late summer pre-approval Inspection Q&A
Inhalation (Impact on Lung Function)
-Animal Studies and 3 clinical studies (normal volunteer) using 3 doses over 24-36hrs that looked at pulmonary function. There were no effects! There were also 2 reactive airway studies in pts w/ COPD & patients w/asthma. IS AN FDA PANEL ANTICIPATED? NO. Pre NDA meeting ALXA specifically asked the FDA & “suggestion was that they would not need an advisory panel. The FDA reserves the right to change their mind but unlikely change given the amount of time it takes to convene a panel and how far ahead you have to schedule to invite panel members.
A panel is convened when there is a “tight walk” b/w efficacy & safety of a clinical trial or there is a clinical endpoint that needs to be debated or clarified. Lung Function in Smokers
80% of patients in schizophrenia trials were smokers
73% of patients in bi-polar were smokers
Smoker/Non-Smoker PK Study-No difference in pharmacokinetics b/w these 2 groups Financials
Cash to run business thru 2011 without the milestones and cash to run business through 2012 w/ the milestones.