Nuplazid Priced at $23,400 / Year

Based on the Acadia Pharmaceuticals first quarter conference call, pricing for the recently approved Nuplazid for Parkinson's Disease Psychosis (PDP), will be around $23,400 per year, wholesale acquisition cost (WAC), much higher than we anticipated.  We previously relied on company information of around $13,000 per year for Nuplazid. The adjustment higher makes a large valuation difference, and puts the recent price of ($27.50) rather cheap based on a potential buyout scenario. 

1,000,000 With Parkinson's in US.
30% develop PDP or Parkinson's Disease Psychosis at some point.
300,000 total patients with PDP.
50% penetration rate of those with the psychosis.
150,000 the actual number treated for PDP with Nuplazid out of 1 million Parkinson's total victims.
$65.00 = WAC price per tablet per day of treatment.  Equates to around $23,400 per year. 
$32.50 = Sales to Acadia per 34 mg tablet after discounts various distributors.
$11,700 = Per patient ACAD annual revenue, ($32.50 per day * 30 days * 12 months)

$1.755 billion = Total peak revenue to ACAD, (150,000 patients * $11,700 annual revenue to ACAD) U.S. Parkinson's Disease Psychosis only.  If applying a buyout scenario of four times peak revenue = $1.755 x 4 = $7.020b valuation / 130k (shares outstanding) = $ 54.00 share price.  It would take 85,470 (PDP) patients treated with Nuplazid to achieve $1 billion in revenue.  Acadia did pre-marketing, and estimated around 11,000 Parkinson's Disease doctors in the U.S.  Each doctor would have to treat 7.77 (PDP) patients with Nuplazid to achieve the $1b in revenue.

Thank you for reading.
 

ACAD: Fourth Quarter Conference Call ($37.78)

The company reiterated their timeline for filing the new drug application (NDA), with the FDA, for the indication of Parkinson's Disease Psychosis, in the first quarter of 2015.  The company also gave more confidence in starting a phase 2 clinical study for patients with Parkinson's Disease who have experienced sleep disturbances. That trial is expected to start in the first half of 2015.  The currently running phase 2 Alzheimer's Disease Psychosis (ADP) trial is expected to complete, and announce data mid year 2016.  The timeline to announce that data has been steadily pushed back in time, previously stated as a two year trial (November 2013 - November 2015) to around two and a half years now. The company has stated that patient selection for the study is a critical process for trial success.  The stock is trading near all-time highs, with a market cap of approximately $3.8 billion. Below is a daily chart.  Thank you for reading.

 

ACAD: Third Quarter Conference Call ($28.21)

There was good and somewhat bad news that ACAD announced today. First the somewhat bad news. The company is delaying the filing of their new drug application with the FDA to the first quarter of 2015, from previously the end of 2014.  They stressed that the delay is not an FDA issue, but more an internal issue of gathering all the pieces, for a well planned filing.  So the company is losing about three months by delaying this filing, not a big picture game changer...

The new information that we have not heard before, was the marketing research the company has been working on over the last year.  The research is below.

• 11,000 U.S. PDP treating physicians, mostly Neurologist
• 1 million Parkinson's Disease patients
• 400,000 thousand patients with PDP
• 50% have disruptive disturbances, (think sleep, or agitation/aggression (my notes)
• Reimbursement Payee is positive on the drug, (commercial, medicaid)
• Pricing of Nuplazid similar to Abilify 20 mg at $13,000 / Wholesale Acquisition Cost (WAC) annually.

 Thank you for reading.

ACAD: Second Quarter Conference Call ($20.77)

The Acadia 2nd quarter conference call went extremely well.  The company still targets the end of the year to file the NDA for PDP. What's even more important is they plan to file an application in the EU for Parkinson's Disease Psychosis six to nine months after filing the NDA with the FDA here in the U.S.  The EU filing has been an overhang on the stock for some time now.  If the company had to run another Phase 3 trial in the EU for PDP, it could take up to another three years and a huge cash drain for that trial.

Future Trials:
Sleep disturbance trial (2014-2015) for Parkinson's patients.  Trial is currently being designed.
Schizophrenia (2015) as Mono-therapy for maintenance stage and symptom control.  Patients cannot tolerate staying on the current approved drugs for an extended period of time.

Safety Stats:
250 patients have been on Pima for one year or longer, 100 patients at least two years or longer, with the longest single patient exposure exceeding eight years.

Bottom Line:  The new information learned today from the company, was related to the potential filing of a marketing authorization application (MAA)  in the EU 6-9 months after filing the new drug application with the FDA.  In other words, they are using the NDA as a fore runner for filing the MAA in the EU. The company is in a very strategic position with patent expiration until 2028, and the company holds worldwide rights to Pimavanserin.  Thank you for reading.

ACAD: Fourth Quarter Conference Call ($28.30)

Acadia held their 4th quarter conference call on Thursday after hours.  A brief of what I found interesting is below.

• The company keyed on the potential for Pimavanserin to be used for schizophrenia patients (in addition to Parkinson's and Alzheimer's patients), both as an add to with a low dose of Resperidone, and as a single therapy for a younger demographic patient.  The company expects to share new information regarding a schizophrenia trial later in 2014.
• The side effects induced by the atypical agents for schizophrenic patients may include weight gain, non-insulin dependent (type II) diabetes, cardiovascular side effects, sleep disturbances, and motor disturbances. The company believes that these side effects generally arise either from non-essential receptor interactions or from excessive dopamine blockade.
• In the released 10-K, it states "Parkinson's disease psychosis is a debilitating disease that occurs up to 60% of patients with Parkinson's disease."   
• The company believes that psychosis from Alzheimer's disease occurs in approximately 25%-50% of patients.
• The company has hired 14 new employees for the commercial launch of Pimavanserin, which I believe could occur in the first quarter of 2015.
• The company is pleased with all the pre-filing testing requirements that has occurred to date, and plans on meeting with the FDA for pre-NDA direction in the spring.

Bottom Line:  The highlight of ACAD's fourth quarter conference call pertains to the positive comments regarding Pimavanserin for schizophrenia patients and the two potential paths for trials they can focus on for this indication in the future. Also, the company is pleased with all required NDA filing testing to date, and will meet with the FDA in the spring. It was a solid conference call from Acadia's management again.  Thanks for reading.

ACAD: Third Quarter Conference Call ($21.00)

It was a positive 3rd quarter conference call from ACAD after hours today. The main points to consider are listed below.

A)  The company will start a phase 2 Alzheimer's trial in November with Pimavanserin for patients with (ADP) Alzheimer's Disease Psychosis.
B)  Three month stability testing has been completed in October.  Typically the FDA would like to see 12 month stability testing when submitting a new drug application.  Perhaps they can submit while continuing additional stability testing in progress.
C)  They will have 75 sales representatives in the US to sell Pimavanserin for PDP, and more than likely partner outside of U.S.
D)  Regarding the EU approval process for PDP.  ACAD will talk with the EU in the fall of 2013.
E)  Currently 200 patients have been taking Pima for over one year, and 100 patients over two years.  The longest patient has been taking Pima for eight years.  More proof of solid safety data that Pimavanserin offers that other atypical drugs do not.

Bottom Line:  ACAD is doing everything right by preparing to start the Alzheimer's phase 2 trial in November, and at the same time is readying data for FDA approval for PDP by the end of 2014.  The stock has come down considerably making the price today a good area to start a position. Thank you for reading.

ACAD: First Quarter Conference Call ($12.03)

Since ACAD is a emerging biotech, there is not much to read into the financial part of the news release, other than what their cash on hand and expected year end cash will be.
-ACAD currently has $101.5 million in cash and expects to end 2013 with around $78 million.
-With their impressive phase III results for Pimavanserin for Parkinsons disease psychosis (PDP), they are planning an expedited path to an NDA (new drug application) filing expected mid 2014.
-Plan on initiating a phase II study with their lead drug Pima for Alzheimer's disease end of 2013.
-During the conference call today the CEO also stated that the FDA has not approved any drug for the treatment for PDP, and that there is no current drug to effectively treat Alzheimer's (ADP) either.

The stock on a weekly basis above, is still overbought despite the pullback from the high upper 13.00 level.  Overall, the stock has held up quite well since doubling in price over the last few months.  

Bottom Line:  ACAD is in a very good position with plenty of cash for now, a long patent life to 2028, and a single, safe and effective drug for PDP and potentially Alzheimer's.  Thank you for reading.