piper 8/05: * Yesterday, August 10, after the close, ACADIA reported 2Q:05 revenues of $2.5 million, slightly higher than our $2.3 million estimate. Due to higher than expected revenues from Allergan and Sepracor, ex-potential milestone payments, we now look for total revenues to reach $9.8 million in 2005.
* ACADIA continues to invest R&D prudently to advance its clinical pipeline. 2Q:05 R&D expenses of $6.5 million were below our $7 million budget. We are reducing our forecast and look for R&D expenses of $28.2 million for the year.
* ACADIA lost $6.0 million or ($0.26) per share in 2Q:05, ($0.02) better than our ($0.28) estimate. We now look for ACADIA to lose $25.8 million or ($1.17) per share in 2005, compared to our prior ($1.29) per share forecast.
* In 1H:05, ACADIA has been very active in strengthening the balance sheet. The company raised ~$44 million and now retains a cash position of $67 million or $2.93 per share, which should last through mid-2007. ACADIA will also receive an additional $10 million in January 2006, on the one-year anniversary of the Sepracor alliance.
* In 2H:05, ACADIA will likely have significant clinical data releases, and we recommend purchase of shares ahead of these events.
* The June interim analysis of Phase II data on ACP-103 in Parkinson's disease increased our confidence in a successful outcome. We expect this trial to complete later this year with full data available late this year or early 2006. If all goes well, we believe this program could advance into Phase III trials next year.
* We look for Phase II data on ACP-103 as adjunctive therapy in schizophrenia in 2H:05. ACADIA has initiated a larger 400-patient trial with other antipsychotic agents. Recruitment is on-going in the U.S. and will begin shortly in Brazil. Look for an interim analysis for this trial in 2006.
* Lastly, ACADIA should also present interim Phase II data on ACP-104 (the major metabolite of clozapine) as a stand-alone therapy for the treatment of schizophrenia and begin a larger trial assessing cognitive benefits in schizophrenics by year-end. From To Price: $8.69 Changes (Previous) (Current) 52 Week High: $9.80 Rating -- Outperform 52 Week Low: $5.00 Price Tgt -- $13.00 Price Target: $13.00 Shares Out (mil): 23.5 Market Cap. (mil): $204.2 Avg Daily Vol (000): 60 Book Value/Share: $2.60 Cash Per Share: $2.93 Est LT EPS Growth: NM P/E to LT EPS Growth (FY06): NA Est Next Rep Date: 11/16/2005 Fiscal Year End: Dec INVESTMENT RECOMMENDATION: We reiterate our Outperform rating and $13 per share price target based on a projected enterprise value of $250 million. ACADIA expects to have significant clinical data releases in 2H:05, and we recommend purchase of shares ahead of these events. RISKS TO ACHIEVEMENT OF TARGET PRICE: Risks associated with shares of ACAD are common to all drug discovery companies, including developmental, clinical and regulatory. Drug candidates could fail in the clinic, ACADIA may not enter into new collaborations or achieve milestones in existing alliances. The company may require future capital funding and may face future unforeseen litigation. COMPANY DESCRIPTION: ACADIA Pharmaceuticals is a biopharmaceutical company developing novel small- molecule drugs to treat CNS disorders. The company's 3 lead Phase II drugs are ACP-103 for treatment-induced side-effects in Parkinson's Disease and schizophrenia and ACP-104 for schizophrenia. ACADIA has partnerships with Allergan and Sepracor. |