- Fourth Quarter 2018 Net Sales Grew to
- Full Year 2018 Net Sales Grew to
- Late Stage Pipeline Progressing with Five Clinical Programs Ongoingor Commencing in 2019
- 2019 Guidance: Net Sales
“Our team successfully executed on all three of our strategic pillars in2018. We grew NUPLAZID in Parkinson’s disease psychosis,leveraged pimavanserin in additional large market CNS indications withpositive data from our Phase 2 CLARITY study in adjunctive treatment ofmajor depressive disorder, and expanded our CNS pipeline with theacquisition of the North American rights for trofinetide,” said
Recent Highlights
- Announced positive top-line results from the Phase 2 CLARITY trial ofpimavanserin for adjunctive treatment in patients with majordepressive disorder (MDD) in
October 2018 . - Conducted an End-of-Phase 2 meeting with the
FDA confirming thedevelopment plans for pimavanserin as a potential adjunctive therapyfor MDD inFebruary 2019 . - The Company plans to initiate two Phase 3 trials for pimavanserin asan adjunctive treatment for MDD in the first half of 2019.
- The Company has confirmed its Phase 3 study design for trofinetide inRett syndrome with the
FDA and plans to initiate this trial in thesecond half of 2019. - Completed a public offering with net proceeds of approximately
$298.5million inNovember 2018 . - Appointed
Serge Stankovic , M.D., M.S.P.H., as President inNovember2018 .
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin)were
Research and Development
Research and development expensesfor the fourth quarter of 2018 were
Selling, General and Administrative
Selling, general andadministrative expenses for the fourth quarter of 2018 were
Net Loss
For the fourth quarter of 2018, ACADIA reported anet loss of
Cash and Investments
At
2019 Financial Guidance
- NUPLAZID net sales are expected to be between
$275 million and $300million . - GAAP R&D is expected to be between
$250 million and $265 million . Theincrease compared to 2018 reflects the planned progression of fivelate-stage clinical programs in 2019. - GAAP SG&A is expected to be between
$280 million and $295 million . - Non-cash stock-based compensation expense is expected to be between
$80 million and $90 million .
Conference Call and Webcast Information
ACADIA managementwill review its fourth quarter and full year 2018 financial results andoperations via conference call and webcast today at
About NUPLAZID® (pimavanserin)
NUPLAZIDis the first and only
About
ACADIA is a biopharmaceuticalcompany focused on the development and commercialization of innovativemedicines to address unmet medical needs in central nervous systemdisorders. ACADIA has developed and is commercializing the first andonly medicine approved for the treatment of hallucinations and delusionsassociated with Parkinson’s disease psychosis. In addition, ACADIA hasongoing clinical development efforts in additional areas withsignificant unmet need, including dementia-related psychosis,schizophrenia inadequate response, schizophrenia-negative symptoms,major depressive disorder, and Rett syndrome. This press release andfurther information about ACADIA can be found at: www.acadia-pharm.com.
Forward-Looking Statements
Statements in this press releasethat are not strictly historical in nature are forward-lookingstatements. These statements include, but are not limited to, statementsrelated to: the potential opportunity for future growth in sales ofNUPLAZID, including through sales of new dosages and forms; the timingof ongoing and future clinical studies for pimavanserin; the developmentand commercialization of trofinetide; and guidance for full-year 2019NUPLAZID net sales and certain expense line items. These statements areonly predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statements dueto various factors, including the uncertainty of future commercial salesand related items that would impact net sales during 2019, the risks anduncertainties inherent in drug discovery, development, approval andcommercialization, and the fact that past results of clinical trials maynot be indicative of future trial results. For a discussion of these andother factors, please refer to ACADIA’s annual report on Form 10-K forthe year ended
| ACADIA PHARMACEUTICALS INC. | ||||||||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||||||||||
| Revenues | ||||||||||||||||||||||||
| Product sales, net | $ | 59,571 | $ | 43,562 | $ | 223,807 | $ | 124,901 | ||||||||||||||||
| Total revenues | 59,571 | 43,562 | 223,807 | 124,901 | ||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||
| Cost of product sales, license fees and royalties (1) | 4,392 | 3,703 | 18,330 | 13,060 | ||||||||||||||||||||
| Research and development (1) | 48,183 | 43,179 | 187,163 | 149,189 | ||||||||||||||||||||
| Selling, general and administrative (1) | 74,271 | 66,689 | 265,758 | 255,062 | ||||||||||||||||||||
| Total operating expenses | 126,846 | 113,571 | 471,251 | 417,311 | ||||||||||||||||||||
| Loss from operations | (67,275 | ) | (70,009 | ) | (247,444 | ) | (292,410 | ) | ||||||||||||||||
| Interest income, net | 1,670 | 1,107 | 5,348 | 4,126 | ||||||||||||||||||||
| Other expense | 127 | — | (1,840 | ) | — | |||||||||||||||||||
| Loss before income taxes | (65,478 | ) | (68,902 | ) | (243,936 | ) | (288,284 | ) | ||||||||||||||||
| Income tax expense | 14 | (31 | ) | 1,256 | 1,119 | |||||||||||||||||||
| Net loss | $ | (65,492 | ) | $ | (68,871 | ) | $ | (245,192 | ) | $ | (289,403 | ) | ||||||||||||
| Net loss per common share, basic and diluted | $ | (0.50 | ) | $ | (0.55 | ) | $ | (1.94 | ) | $ | (2.36 | ) | ||||||||||||
| Weighted average common shares outstanding, basic and diluted | 131,627 | 124,117 | 126,583 | 122,600 | ||||||||||||||||||||
| (1) Includes the following share-based compensationexpense | ||||||||||||||||||||||||
| Cost of product sales, license fees and royalties | $ | 838 | $ | 719 | $ | 3,863 | $ | 3,690 | ||||||||||||||||
| Research and development | $ | 8,421 | $ | 7,887 | $ | 32,038 | $ | 26,485 | ||||||||||||||||
| Selling, general and administrative | $ | 11,142 | $ | 13,413 | $ | 45,663 | $ | 45,357 | ||||||||||||||||
| ACADIA PHARMACEUTICALS INC. | ||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
(in thousands) | ||||||||||
December 31, | December 31, | |||||||||
| (unaudited) | ||||||||||
| Assets | ||||||||||
| Cash, cash equivalents and investment securities | $ | 473,520 | $ | 341,342 | ||||||
| Accounts receivable, net | 26,090 | 17,343 | ||||||||
| Interest and other receivables | 1,699 | 1,087 | ||||||||
| Inventory | 4,070 | 5,248 | ||||||||
| Prepaid expenses | 20,727 | 8,457 | ||||||||
| Total current assets | 526,106 | 373,477 | ||||||||
| Property and equipment, net | 3,309 | 2,662 | ||||||||
| Intangible assets, net | 4,062 | 5,538 | ||||||||
| Restricted cash | 4,826 | 2,475 | ||||||||
| Other assets | 1,899 | 354 | ||||||||
| Total assets | $ | 540,202 | $ | 384,506 | ||||||
| Liabilities and stockholders’ equity | ||||||||||
| Accounts payable | $ | 3,167 | $ | 8,786 | ||||||
| Accrued liabilities | 56,398 | 40,244 | ||||||||
| Total current liabilities | 59,565 | 49,030 | ||||||||
| Long-term liabilities | 1,558 | 191 | ||||||||
| Total liabilities | 61,123 | 49,221 | ||||||||
| Total stockholders’ equity | 479,079 | 335,285 | ||||||||
| Total liabilities and stockholders’ equity | $ | 540,202 | $ | 384,506 | ||||||
Important Safety Information and Indication forNUPLAZID (pimavanserin)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS
- Elderly patients with dementia-related psychosis treated withantipsychotic drugs are at an increased risk of death.
- NUPLAZID is not approved for the treatment of patients withdementia-related psychosis unrelated to the hallucinations anddelusions associated with Parkinson’s disease psychosis.
Contraindication: NUPLAZID is contraindicated in patients with ahistory of a hypersensitivity reaction to pimavanserin or any of itscomponents. Rash, urticaria, and reactions consistent with angioedema(e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea)have been reported.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. Theuse of NUPLAZID should be avoided in patients with known QT prolongationor in combination with other drugs known to prolong QT intervalincluding Class 1A antiarrhythmics or Class 3 antiarrhythmics, certainantipsychotic medications, and certain antibiotics. NUPLAZID should alsobe avoided in patients with a history of cardiac arrhythmias, as well asother circumstances that may increase the risk of the occurrence oftorsade de pointes and/or sudden death, including symptomaticbradycardia, hypokalemia or hypomagnesemia, and presence of congenitalprolongation of the QT interval.
Adverse Reactions: The most common adverse reactions (≥2% forNUPLAZID and greater than placebo) were peripheral edema (7% vs 2%),nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
Drug Interactions: Coadministration with strong CYP3A4 inhibitors(e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID doseto 10 mg taken orally as one tablet once daily. Coadministration withstrong CYP3A4 inducers may reduce NUPLAZID exposure. Monitor patientsfor reduced efficacy and an increase in NUPLAZID dosage may be needed.
Pediatric Use: Safety and efficacy have not been established inpediatric patients.
Dosage and Administration: Recommended dose: 34 mg taken orallyonce daily, without titration.
Indication: NUPLAZID is an atypical antipsychotic indicated forthe treatment of hallucinations and delusions associated withParkinson’s disease psychosis.
You are encouraged to report negative side effects of prescription drugsto the
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please see the full Prescribing Information including Boxed WARNINGfor NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
ElenaRidloff, CFA
(858) 558-2871
ir@acadia-pharm.com
Media Contact:
ACADIA Pharmaceuticals Inc.
MaurissaMessier
(858) 768-6068
media@acadia-pharm.com