- 2Q20 Net Sales of $110.1 Million, a 32%
Increase Over 2Q19
- FDA filed the supplemental NDA for
pimavanserin for the treatment of dementia-related psychosis with a
PDUFA action date set for April 3, 2021
- Initiated ADVANCE-2, a Phase 3 study
evaluating pimavanserin for the treatment of the negative symptoms
of schizophrenia
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in central
nervous system disorders, today announced its financial results for
the second quarter ended June 30, 2020.
“In the first half of 2020 we drove robust growth of NUPLAZID®.
With the FDA filing of our sNDA for dementia-related psychosis we
are one step closer to potentially delivering the first and only
approved treatment for this devastating condition,” said Steve
Davis, ACADIA’s Chief Executive Officer. “Building upon the
successful development of our PDP and DRP programs, our clinical
team is focused on advancing our innovative early- and late-stage
pipeline.”
Company Updates
- The U.S. Food and Drug Administration (FDA) filed the
supplemental NDA for pimavanserin for the treatment of the
hallucinations and delusions associated with dementia-related
psychosis (DRP). The FDA has assigned a PDUFA (Prescription Drug
User Fee Act) action date of April 3, 2021.
- ACADIA announced top-line results from the Phase 3 CLARITY
study of pimavanserin for adjunctive treatment in patients with
major depressive disorder. The study did not achieve statistical
significance on the primary endpoint which was the 17-item Hamilton
Depression Rating Scale (HAMD-17) total score.
- ACADIA initiated its second pivotal study, ADVANCE-2, a
26-week, placebo-controlled, 386 patient Phase 3 study designed to
evaluate the efficacy and safety of the 34 mg dose of pimavanserin
for the treatment of the negative symptoms of schizophrenia.
- ACADIA presented important clinical data at recent virtual
medical congresses:
- In May, at the 2020 American Society of Clinical
Psychopharmacology virtual annual meeting, ACADIA presented six
posters and an oral presentation on the positive pivotal ADVANCE
study results, titled ADVANCE: Phase 2, Randomized, Double-Blind,
Placebo-Controlled Study of Adjunctive Pimavanserin in Patients
with Negative Symptoms of Schizophrenia.
- In July, at the 2020 Alzheimer’s Association International
Conference virtual event, ACADIA presented nine posters and an oral
presentation on the positive findings from the open-label portion
of the HARMONY study, titled HARMONY: Response to Pimavanserin in
the 12-Week, Open-label Treatment Phase.
- ACADIA appointed Mark Schneyer as Senior Vice President,
Business Development and Chief Business Officer and appointed
Spyros Papapetropoulos, M.D., Ph.D., as Senior Vice President, Head
of Clinical Development.
Financial Results
Revenue
Net sales of NUPLAZID (pimavanserin) were $110.1 million for the
three months ended June 30, 2020, an increase of 32% as compared to
$83.2 million reported for the three months ended June 30, 2019.
For the six months ended June 30, 2020 and 2019, ACADIA reported
net product sales of $200.2 million and $146.2 million,
respectively.
Research and Development
Research and development expenses for the three months ended
June 30, 2020 were $64.3 million, compared to $67.3 million for the
same period of 2019. The decrease in the three month period ending
June 2020 compared to June 2019 was primarily due to lower
development costs for pimavanserin in schizophrenia and DRP. For
the six months ended June 30, 2020 and 2019, research and
development expenses were $136.9 million and $120.2 million,
respectively. The increase during the six month period ending June
2020 compared to June 2019 was primarily due to an upfront payment
of $10.0 million to Vanderbilt University for the M1 PAM program
and increased development costs associated with trofinetide, offset
by decreased development costs for pimavanserin in schizophrenia
and DRP.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended June 30, 2020 were $84.3 million, compared to $68.0
million for the same period of 2019. For the six months ended June
30, 2020 and 2019, selling, general and administrative expenses
were $186.3 million and $161.1 million, respectively. The increase
during the 2020 periods as compared to 2019 was primarily due to
increased advertising and promotional costs as well as an increase
in personnel and related costs.
Net Loss
For the three months ended June 30, 2020, ACADIA reported a net
loss of $42.1 million, or $0.27 per common share, compared to a net
loss of $54.9 million, or $0.38 per common share, for the same
period in 2019. The net losses for the three months ended June 30,
2020 and 2019 included $19.5 million and $20.4 million,
respectively, of non-cash stock-based compensation expense. For the
six months ended June 30, 2020, ACADIA reported a net loss of
$130.2 million, or $0.83 per common share, compared to a net loss
of $140.2 million, or $0.97 per common share, for the same period
in 2019. The net losses for the six months ended June 30, 2020 and
2019 included $41.9 million and $40.3 million, respectively, of
non-cash stock-based compensation expense.
Cash and Investments
At June 30, 2020, ACADIA’s cash, cash equivalents, and
investment securities totaled $658.6 million, compared to $697.4
million at December 31, 2019.
2020 Financial Guidance
- NUPLAZID net sales guidance is updated to $430 to $450 million
from the previous range of $420 to $450 million.
- GAAP R&D guidance is decreased to $265 to $280 million from
the previous range of $270 to $285 million.
- GAAP SG&A guidance is decreased to $400 to $420 million
from the previous range of $425 to $445 million.
- Non-cash stock-based compensation expense guidance of $90 to
$100 million is unchanged compared to prior guidance.
- 2020 year-end cash, cash equivalents, and investment securities
is expected to be $570 to $590 million from a previous range of
$470 to $500 million.
Conference Call and Webcast
Information
ACADIA management will review its
second quarter financial results and operations via conference call
and webcast today at 4:30 p.m. Eastern Time. The conference call
may be accessed by dialing 855-638-4820 for participants in the
United States or Canada and 443-877-4067 for international callers
(reference passcode 9828845). A telephone replay of the conference
call may be accessed through August 19, 2020 by dialing
855-859-2056 for callers in the United States or Canada and
404-537-3406 for international callers (reference passcode
9828845). The conference call also will be webcast live on ACADIA’s
website, www.acadia-pharm.com, under the investors section and will
be archived there until September 2, 2020.
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only FDA-approved treatment for
hallucinations and delusions associated with Parkinson’s disease
psychosis. NUPLAZID is a selective serotonin inverse
agonist/antagonist preferentially targeting 5-HT2A receptors that
are thought to play an important role in Parkinson’s disease
psychosis. NUPLAZID is an oral medicine taken once a day with a
recommended dose of 34 mg. NUPLAZID is not FDA-approved for any
other neuropsychiatric disorders. ACADIA discovered and developed
this new chemical entity and holds worldwide rights to develop and
commercialize NUPLAZID.
About Trofinetide
Trofinetide is an investigational drug. It is a novel synthetic
analog of the amino‐terminal tripeptide of IGF-1 designed to treat
the core symptoms of Rett syndrome by potentially reducing
neuroinflammation and supporting synaptic function. In the central
nervous system, IGF-1 is produced by both of the major types of
brain cells – neurons and glia. IGF-1 in the brain is critical for
both normal development and for response to injury and disease.
Trofinetide has been granted Fast Track Status and Orphan Drug
Designation in the U.S. and Orphan Drug Designation in Europe for
both Rett syndrome and Fragile X syndrome.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development
and commercialization of innovative medicines to address unmet
medical needs in central nervous system disorders. ACADIA has
developed and commercialized the first and only medicine approved
for the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis. ACADIA’s development efforts are
focused on pimavanserin for additional neuropsychiatric conditions,
trofinetide for Rett syndrome, and an early-stage muscarinic
receptor program. This press release and further information about
ACADIA can be found at: www.acadia-pharm.com.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These
statements include, but are not limited to, statements related to:
the potential opportunity for future growth in sales of NUPLAZID;
the timing of ongoing and future clinical studies for pimavanserin;
the development and commercialization of trofinetide; unanticipated
impacts of COVID-19 on ACADIA’s business, including its commercial
sales operations, current and planned clinical trials, supply
chain, and guidance for full-year 2020 NUPLAZID net sales and
certain expense line items. These statements are only predictions
based on current information and expectations and involve a number
of risks and uncertainties. Actual events or results may differ
materially from those projected in any of such statements due to
various factors, including the uncertainty of future commercial
sales and related items that would impact net sales during 2020,
the risks and uncertainties inherent in drug development, approval
and commercialization, and the fact that past results of clinical
trials may not be indicative of 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 ended December 31, 2019 as
well as ACADIA’s subsequent filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof. This caution is made under the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date 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,
2020
2019
2020
2019
Revenues
Product sales, net
$
110,103
$
83,205
$
200,171
$
146,164
Total revenues
110,103
83,205
200,171
146,164
Operating expenses
Cost of product sales, license fees and
royalties (1)
5,474
4,995
10,448
9,575
Research and development (1)
64,295
67,320
136,931
120,243
Selling, general and administrative
(1)
84,344
67,981
186,317
161,071
Total operating expenses
154,113
140,296
333,696
290,889
Loss from operations
(44,010
)
(57,091
)
(133,525
)
(144,725
)
Interest income, net
1,825
2,527
4,814
5,461
Other income (expense)
437
(12
)
(1,060
)
(241
)
Loss before income taxes
(41,748
)
(54,576
)
(129,771
)
(139,505
)
Income tax expense
393
365
393
740
Net loss
$
(42,141
)
$
(54,941
)
$
(130,164
)
$
(140,245
)
Net loss per common share, basic and
diluted
$
(0.27
)
$
(0.38
)
$
(0.83
)
$
(0.97
)
Weighted average common shares
outstanding, basic and diluted
156,535
144,314
155,951
144,148
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
743
$
803
$
1,592
$
1,798
Research and development
$
7,235
$
7,901
$
15,692
$
15,781
Selling, general and administrative
$
11,529
$
11,718
$
24,571
$
22,726
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
June 30,
2020
December 31,
2019
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
658,551
$
697,429
Accounts receivable, net
43,785
35,781
Interest and other receivables
2,343
2,093
Inventory
6,210
6,341
Prepaid expenses
24,846
18,606
Total current assets
735,735
760,250
Property and equipment, net
6,687
3,180
Operating lease right-of-use assets
7,880
9,524
Intangible assets, net
1,846
2,585
Restricted cash
5,770
4,787
Other assets
1,731
2,857
Total assets
$
759,649
$
783,183
Liabilities and stockholders’
equity
Accounts payable
$
6,466
$
7,222
Accrued liabilities
79,956
67,604
Total current liabilities
86,422
74,826
Operating lease liabilities
5,669
6,361
Other long-term liabilities
4,545
2,861
Total liabilities
96,636
84,048
Total stockholders’ equity
663,013
699,135
Total liabilities and stockholders’
equity
$
759,649
$
783,183
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200805005935/en/
Media Contact: ACADIA Pharmaceuticals Inc. Stephanie Fagan (858)
212-0534 media@acadia-pharm.com
Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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