JPM $ACAD ACADIA Pharmaceuticals (ACAD
US)
Takeaways from our Fall CEO Conference Call Series
Yesterday, as part of our 2016 Fall Biotech Conference Call Series, we hosted a call with ACAD’s CEO
Stephen Davis and CCO Terry Moore. The discussion focused on the company’s newly launched Nuplazid in
Parkinson’s disease psychosis as well as potential expansion indications, including Alzheimer’s disease
psychosis and agitation. Below, we provide some highlights and we will send a transcript shortly. A replay of
the call is also available through October 26 with the following dial-in info: 866-431-2903 (US); +1-203-369-
0952 (outside US); Passcode: 1926.
Nuplazid in PDP
 With 90 business days into launch of Nuplazid, everything is going “according to plan.”
 Payer access update: Patients on gov’t plans have access as expected given that this is a protected class.
Overall, Medicare represents two-thirds of the target market…with half of that being low income subsidy
(LIS). On the commercial side, ~one-third of plans are on-line with the rest expected to come on-line over the
next 6-9 months. Roughly three-fourths of these plans only require a simple confirmation of diagnosis; the
other one-fourth require step edits through clozapine. Overall, payer interactions have been in line with
expectations from market research.
 Anecdotal doc feedback has been “very positive” and “entirely consistent” with what was observed in clinical
trials – full responses and remissions seen in some patients; drug has a strong anti-psychotic effect; and safety
has been “very favorable.”
 133 sales reps are out in the field targeting 12,000 physicians (specialists are the top priority, followed by
general neurologists and psychiatrists). ACAD has now contacted all 12,000 at least once. Precedent is that it
can take seven to eight visits to change docs prescribing behavior.
 There are 150,000 PDP patients who are disruptive enough to receive treatment, a majority of whom are on
low dose Seroquel. Many are not satisfied with what they experience on Seroquel and are willing to switch.
 The commercialization strategy is three-fold – increase disease awareness, increase brand awareness and
differentiate Nuplazid from currently used anti-psychotics.
 NuplazidConnect has received positive feedback with no wrinkles or impediments seen.
 ACAD’s sampling strategy is two-pronged – docs can opt for a 30-day free trial (on average delivery occurs
five- to six days after receiving the form) or a sales rep can leave one-week samples in the physician’s office.
ACAD has had success with both sampling in office as well as the 30-day free trial. Management highlighted
that the most important thing is laying out the foundation in the medical community and assuring access to the
drug. The company noted that there are no sampling restrictions.
 For commercial patients, ACAD covers all out-of-pocket costs. For gov’t payors, a foundation provides outof-
pocket assistance, not ACAD. As indicated, two-thirds of the business is Medicare, with half of those
comprised of low income subsidies with a small copay (<$7).
 ACAD does not expect to guide on top or bottom line in the near term. During the upcoming earnings call,
management is not promising that they will discuss launch metrics. When the launch reaches a point where

and would be counterproductive to understanding the business. We note that this has recently been a point of
contention for investors.
 On the MAA filing, ACAD has submitted a new pediatric plan (the cycle takes a few months). Clarity is
expected soon and if it is sufficient, ACAD is ready to move ahead with the MAA filing; it will get resolved
but will take time.
 On the international strategy, ACAD remains non-committal regarding a possible OUS partnership(s). The
company doesn’t plan to launch independently in Japan. The MAA filing would be followed by a period of six
to eight months before market authorization and then even more time for pricing to come on line so there’s
time. Additional considerations for the timing of a potential partnership include the imminent Phase 2 ADP
data.
Nuplazid in ADP
 By the end of this year, ACAD expects to release Phase 2 data in ADP (in addition to initiating a trial in
Alzheimer’s disease agitation and unveiling new studies in additional indications).
 On the rationale for the single-center Phase 2 ADP study, at the time it was designed, the goal was to
incorporate centralized readers (if it’s too small the results could be skewed and if it’s too large there could be
a high degree of variability). Also at the time, there was a relative lack of nursing home sites that could
conduct the study, so the Kings College network was preferred. While this is technically a single site, the
network includes 130 nursing homes.
 On the upcoming Phase 2 proof-of-concept data in ADP, ACAD indicated that it will pressure test the data, no
matter what the outcome is. If highly stat sig, it will make sure to understand every element of the data. If the
trial isn’t stat sig but there is a signal in a certain patient population or on a certain endpoint, the company
could adjust potential future trials accordingly. It is an early exploratory POC trial, so it is important to look at
the data and determine what to do next.
 ADP vs. PDP: a robust effect was seen in PDP and schizophrenia (two very different disorders). The goal is to
treat the symptoms which are not identical but are similar. Have more faith in clinical results than
biochemistry (biochemistry is important too but it’s more directional).
 On the pending Alzheimer’s disease agitation trial, there are no gating items to get the study up and running.
Rather it is just processing through logistics; the trial is expected to begin by YE16. ACAD does not know
how long the trial will take at this point – it will need to see how enrollment progresses to get a better sense
(these kinds of studies could take a couple of years

Reply · Report Post