In several ways, Acadia Pharmaceuticals (NASDAQ:ACAD) crushed it in 2017. The launch for Nuplazid in treating Parkinson's disease (PD) psychosis went better than expected, with sales beating Wall Street estimates. Acadia moved ahead with its late-stage studies for the drug in other indications. The FDA granted breakthrough therapy designation to Nuplazid for dementia-related psychosis. Despite all of this good news, Acadia stock finished the year up only 4%.
Acadia CEO Stephen Davis didn't mention the underwhelming performance of the stock when he spoke at the J.P. Morgan Healthcare Conference on Tuesday. Instead, his focus was more on the future. Davis provided the path that Acadia intends to take to achieve greater success in 2018 and beyond. Here are three of the keys for success he identified.
1. Increase patient awareness of Nuplazid
Although Nuplazid enjoyed solid momentum in 2017, Davis acknowledged one challenge for Acadia. Although more than half of PD patients experience PD psychosis, many of them aren't aware that they do. Others realize that they experience symptoms but don't tell their healthcare providers. It's estimated that 10% to 20% of all PD patients fit one of these two categories.
Acadia's game plan, therefore, is to do all it can to increase patient and caregiver awareness of Nuplazid. Davis said the company is trying to accomplish this goal in three ways.
First, Acadia began an integrated communications campaign, which included TV commercials and a website containing doctor discussion guides, videos targeted toward caregivers and patients, and a physician finder application for patients. Davis also stated that Acadia has trained speakers to present at Parkinson's disease patient advocacy groups. Acadia's third approach for increasing patient awareness is placing media and educational tools in healthcare providers' offices.
2. Increase long-term care penetration
PD psychosis is a leading cause of nursing home admissions among patients with PD. Acadia knew even before it launched Nuvazid that targeting long-term care (LTC) would need to be a top priority. Davis stated that the results so far for this effort have been good. However, he also said Acadia needs to increase its LTC penetration.
One important factor behind the company's success so far is its sales team dedicated to the LTC market. Davis noted that this team expanded in size in April 2017.
This sales team now has a little help in its efforts. The Centers for Medicare and Medicaid Services (CMS) have pressured nursing homes to reduce the number of psychotropic drugs patients take. However, CMS provided new regulatory guidance for nursing homes that allows prescribers to continue treatment with Nuplazid as long as the patient is demonstrating a benefit from the drug.
3. Achieve positive results in clinical studies
The third key for Acadia's success is to achieve positive results in clinical studies evaluating Nuplazid in treating other indications. Acadia expects to announce results from a phase 2 study targeting major depressive disorder in the second half of 2018. There is a significant unmet medical need for this indication: Only around half of the 16 million Americans with major depressive disorder receive treatment -- and the majority of these patients don't respond to initial antidepressant therapy.
Acadia anticipates announcing results from two other studies in 2019. The company's late-stage study of Nuplazid in treating schizophrenia in patients who inadequately respond to treatment could be a big catalyst. One-third of adults treated for schizophrenia don't respond to treatment, with another third only partially responding. Data from a phase 2 study of Nuplazid as an adjunctive treatment for patients with prominent negative symptoms of schizophrenia are also expected to be released next year.
The biggie for Acadia could be its late-stage study targeting dementia-related psychosis. This indication includes psychosis associated with Alzheimer's disease and PD. There are no approved treatments right now, and current drugs used off-label for treating dementia-related psychosis come with serious side effects. This study is scheduled to conclude in 2020.
Can Acadia deliver?
These are the three things Acadia needs to do to be successful, but can the company deliver on these goals? I think so.
Of course, the first two are largely within Acadia's control. My view is that the company is on the right track in its efforts to increase patient awareness of Nuplazid and increase its LTC penetration. All Acadia needs to do now is to keep things going and execute effectively.
How well Nuplazid performs in treating additional indications is a different story. All we have to go on in judging Acadia's chances are prior clinical studies. There's certainly a significant level of risk that Nuplazid won't be effective. However, earlier studies were generally positive. My hunch is that Acadia will rack up more successes with its clinical program.
The biggest challenge for Acadia is playing the Wall Street expectations game. For example, the company reported pretty good results in the third quarter of 2017, but they weren't enough to meet analysts' estimates. Acadia stock tanked as a result.
But investors are better off focusing on the long term instead of temporary dips and fluctuations. In the PD psychosis indication alone, many expect Nuplazid to reach peak annual sales of around $1 billion by 2021. That level by itself is enough to justify Acadia's current market cap of $3.5 billion. And if Acadia's clinical studies go well, the stock should be worth a whole lot more. Acadia's success in 2018 isn't a sure thing, but I think the risk-reward proposition for the stock looks intriguing.