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  • August 8, 2017
  • Earnings

ACADIA Pharmaceuticals Reports Second Quarter 2017 Financial Results

Second Quarter Net Sales Grew to $30.5 Million Including $3.6 MillionFrom Transition to Sell-In Method of Accounting

SAN DIEGO—(BUSINESS WIRE)—Aug. 8, 2017—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in central nervous system (CNS)disorders, today announced its unaudited financial results for thesecond quarter ended June 30, 2017.

“Our commercial efforts continue to drive strong financial performancewith solid market uptake for NUPLAZID in patients with Parkinson’sdisease psychosis,” said Steve Davis, ACADIA’s President and ChiefExecutive Officer. “Following positive data from our Phase II study inAlzheimer’s disease psychosis and recently completed End-of-Phase IImeeting with the FDA, we are excited to start our Phase III program inthe next couple of months.”

During the second quarter of 2017, ACADIA generated $30.5 million of netproduct sales of NUPLAZID, which includes the one-time recognition of$3.6 million associated with the transition to the sell-in revenuerecognition method of accounting from the sell-through method.

Starting with the second quarter of 2017, based on its determination ithad sufficient volume of activity to reasonably estimate its allowancesfor rebates and chargebacks, ACADIA began to recognize revenue at thepoint of sale to its specialty pharmacy and specialty distributorpartners, commonly referred to as the “sell-in” revenue recognitionmethod. Previously, ACADIA had deferred the recognition of revenue untilit obtained evidence that its specialty partners had dispensed theproduct to a patient or had sold the product to a government facility,long-term care pharmacy or in-patient hospital pharmacy. The $3.6million one-time adjustment was deferred revenue as of March 31, 2017and represents product held by specialty pharmacies and specialtydistributors at such date.

For comparison purposes, the following table presents NUPLAZID’s proforma quarterly net product sales under the sell-in method, if ACADIAhad been able to reasonably estimate its allowances for rebates andchargebacks from the time of launch in May 2016.

Pro Forma Reconciliation of Sell-Through to Sell-In Method

(in millions)Three Months Ended
June 30,September 30,December 31,March 31,June 30,
20162016201620172017
NUPLAZID net sales, as reported1$0.1$5.3$12.0$15.3$30.5
Difference20.41.20.51.5(3.6)

Pro forma NUPLAZID net sales, sell-in method

$0.5$6.5$12.5$16.8$26.9

1

Includes the net sales as previously reported for the quarterlyperiods through March 31, 2017 utilizing the sell-through revenuerecognition method.

2

Represents the impact of recognizing the deferred revenue atperiod-end, net of allowances for rebates and chargebacks, had thesales been recognized in the quarter which the product was deliveredto the specialty pharmacies and distributors.

Recent Highlights

Financial Results

Revenue
Net product sales of NUPLAZID, which was first madeavailable for prescription starting in May 2016, were $30.5 million forthe three months ended June 30, 2017 compared to $0.1 million for thethree months ended June 30, 2016. For the six months ended June 30, 2017and 2016, ACADIA reported NUPLAZID net product sales of $45.8 millionand $0.1 million, respectively.

Research and Development
Research and development expensesfor the three months ended June 30, 2017 were $34.2 million, compared to$20.5 million for the same period of 2016. For the six months ended June30, 2017 and 2016, research and development expenses were $69.6 millionand $43.3 million, respectively. The increase in research anddevelopment expenses during the 2017 periods as compared to 2016 wasprimarily due to increased clinical costs related to the schizophreniaand depression studies ACADIA initiated in the fourth quarter of 2016.The company also incurred additional personnel and related costsassociated with its expanded research and development organizationduring 2017 as compared to 2016.

Selling, General and Administrative
Selling, general andadministrative expenses for the three months ended June 30, 2017 were$61.5 million, compared to $50.8 million for the same period of 2016.For the six months ended June 30, 2017 and 2016, selling, general andadministrative expenses were $127.3 million and $78.3 million,respectively. The increase in selling, general and administrativeexpenses during the 2017 periods as compared to 2016 was primarily dueto costs incurred to support ACADIA’s commercial activities for NUPLAZID.

Net Loss
For the three months ended June 30, 2017, ACADIAreported a net loss of $67.4 million, or $0.55 per common share,compared to a net loss of $71.3 million, or $0.63 per common share, forthe same period in 2016. The net losses for the three months ended June30, 2017 and 2016 included $18.2 million and $13.9 million,respectively, of non-cash stock-based compensation expense. For the sixmonths ended June 30, 2017, ACADIA reported a net loss of $155.3million, or $1.27 per common share, compared to a net loss of $121.1million, or $1.08 per common share, for the same period in 2016. The netlosses for the six months ended June 30, 2017 and 2016 included $33.8million and $25.8 million, respectively, of non-cash stock-basedcompensation expense.

Cash and Investments
At June 30, 2017, ACADIA’s cash, cashequivalents, and investment securities totaled $417.3 million, comparedto $529.0 million at December 31, 2016.

2017 Financial Guidance
ACADIA expects that full-yearNUPLAZID net sales for 2017 will be between $105 million and $115million.

Conference Call and Webcast Information
ACADIA managementwill review its second quarter financial results and operations viaconference call and webcast later today at 5:00 p.m. Eastern Time. Theconference call may be accessed by dialing 844-821-1109 for participantsin the U.S. or Canada and 830-865-2550 for international callers(reference passcode 12799639). A telephone replay of the conference callmay be accessed through August 22, 2017 by dialing 855-859-2056 forcallers in the U.S. or Canada and 404-537-3406 for international callers(reference passcode 12799639). The conference call also will be webcastlive on ACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there through August22, 2017.

About NUPLAZID® (pimavanserin)
NUPLAZIDis the first and only FDA-approved treatment for hallucinations anddelusions associated with PD Psychosis. NUPLAZID is a non-dopaminergic,selective serotonin inverse agonist preferentially targeting 5-HT2A receptorsthat are thought to play an important role in PD Psychosis. NUPLAZID isan oral medicine taken once a day with a recommended dose of 34 mg (two17-mg tablets). ACADIA discovered this new chemical entity and holdsworldwide rights to develop and commercialize NUPLAZID.

About ACADIA Pharmaceuticals
ACADIA is a biopharmaceuticalcompany focused on the development and commercialization of innovativemedicines to address unmet medical needs in central nervous systemdisorders. ACADIA maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.

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 guidance for fiscal year 2017 NUPLAZID net sales; thebenefits to be derived from NUPLAZID (pimavanserin); the utility ofpimavanserin in indications other than hallucinations and delusionsassociated with PD Psychosis; and the timing or results of futurestudies involving pimavanserin. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differ materiallyfrom those projected in any of such statements due to various factors,including the uncertainty of future commercial sales and related itemsthat would impact net sales for 2017, the risks and uncertaintiesinherent in drug discovery, development, approval and commercialization,and the fact that past results of clinical trials may not be indicativeof future trial results. For a discussion of these and other factors,please refer to ACADIA’s annual report on Form 10-K for the year endedDecember 31, 2016 as well as ACADIA’s subsequent filings with theSecurities and Exchange Commission. You are cautioned not to place unduereliance on these forward-looking statements, which speak only as of thedate hereof. This caution is made under the safe harbor provisions ofthe Private Securities Litigation Reform Act of 1995. Allforward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise orupdate this press release to reflect events or circumstances after thedate hereof, except as required by law.

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(Unaudited)

Three Months Ended June 30,Six Months Ended June 30,
2017201620172016
Revenues
Product sales, net$30,475

$

97

$

45,761$97
Collaborative revenue4
Total revenues30,4759745,761101
Operating expenses
Cost of product sales2,2245264,487526
License fees and royalties9822481,657248
Research and development34,18020,47869,58943,253
Selling, general and administrative61,52350,768127,26878,259
Total operating expenses98,90972,020203,001122,286
Loss from operations(68,434)(71,923)(157,240)(122,185)
Interest income, net9936011,9561,101
Net loss$(67,441)$(71,322)$(155,284)$(121,084)
Net loss per common share, basic and diluted$(0.55)$(0.63)$(1.27)$(1.08)
Weighted average common shares outstanding, basic and diluted122,122113,308121,888112,327

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

June 30,

2017

December 31,

2016

(unaudited)
Assets
Cash, cash equivalents and investments$417,320$529,036
Accounts receivable, net11,5945,903
Interest and other receivables7841,237
Inventory6,0034,175
Prepaid expenses8,0447,546
Total current assets443,745547,897
Property and equipment, net3,2963,081
Intangible assets, net6,2777,015
Restricted cash2,4752,375
Other assets522785
Total assets$456,315$561,153
Liabilities and stockholders’ equity
Accounts payable$3,588$3,912
Accrued liabilities37,32536,029
Deferred revenue2,644
Total current liabilities40,91342,585
Long-term liabilities262157
Total liabilities41,17542,742
Total stockholders’ equity415,140518,411
Total liabilities and stockholders’ equity$456,315$561,153

Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
WARNING: INCREASEDMORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderlypatients with dementia-related psychosis treated with antipsychoticdrugs are at an increased risk of death. NUPLAZID is not approved forthe treatment of patients with dementia-related psychosis unrelated tothe hallucinations and delusions associated with Parkinson’s diseasepsychosis.

NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.

Contraindication: NUPLAZID is contraindicated in patients with a historyof hypersensitivity reaction to pimavanserin or any of its components.Reactions have included rash, urticaria, tongue swelling, circumoraledema, and throat tightness.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use ofNUPLAZID should be avoided in patients with known QT prolongation or incombination with other drugs known to prolong QT interval includingClass 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%for NUPLAZID and greater than placebo) were peripheral edema (7%vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination(5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole)increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reducedefficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed inpatients with mild to moderate renal impairment. Use of NUPLAZID is notrecommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients withhepatic impairment. NUPLAZID has not been evaluated in this patientpopulation.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated andshould therefore be used in pregnancy only if the potential benefitjustifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established inpediatric patients.

Dosage and Administration: Recommended dose: 34 mg per day, taken orallyas two 17-mg tablets once daily, without titration.

For additional Important Safety Information, including boxed warning,please see the full Prescribing Information for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.

Source: ACADIA Pharmaceuticals Inc.

Investor Contact:
ACADIA Pharmaceuticals Inc.
LisaBarthelemy, 858-558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft Communications
Bob Laverty,609-558-5570
bob@taftcommunications.com

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