- Full Year 2019 Net Sales Grew to $339.1
Million, a 52% Increase over Full Year 2018
- 2020 Net Sales Guidance of $440 to $470
Million
- On-Track to Submit Supplemental New Drug
Application for Dementia-Related Psychosis in Summer 2020
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced
financial results for the fourth quarter and full year ended
December 31, 2019.
“In 2019 ACADIA demonstrated strong execution from our
commercial and R&D teams, driving the continued growth of
NUPLAZID and advancing our late-stage pipeline,” said Steve Davis,
Chief Executive Officer. “2020 will be a transformational year for
ACADIA highlighted by a potential approval in dementia-related
psychosis, additional pivotal study results in major depressive
disorder, commencement of a second pivotal study for the negative
symptoms of schizophrenia and the continued enrollment of the Phase
3 trofinetide study for Rett syndrome. This exciting momentum has
created a multi-year cadence of pivotal study readouts and
potential regulatory approvals that position the company for
long-term growth.”
Company Highlights
- Presented positive top-line results from the Phase 3 HARMONY
study of pimavanserin for the treatment of dementia-related
psychosis at the Clinical Trials on Alzheimer's Disease (CTAD)
meeting on December 4, 2019.
- The Company plans to submit a supplemental NDA for pimavanserin
for the treatment of dementia-related psychosis in the summer of
2020. Pimavanserin previously received Breakthrough Therapy
Designation for this indication.
- Announced positive top-line results from the pivotal Phase 2
ADVANCE study of pimavanserin for the negative symptoms of
schizophrenia in November 2019.
- The Company plans to initiate a second pivotal study,
ADVANCE-2, of pimavanserin for the negative symptoms of
schizophrenia during the summer of 2020.
- The Company expects to announce top-line results from its Phase
3 CLARITY-2 study of pimavanserin as an adjunctive treatment for
major depressive disorder in the fourth quarter of 2020.
- Appointed Ponni Subbiah, M.D., M.P.H., as Senior Vice
President, Global Head of Medical Affairs and Chief Medical Officer
and Stephanie Fagan as Senior Vice President, Corporate Affairs and
Chief Communications Officer.
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin) were $98.3 million for the
fourth quarter of 2019, an increase of 65% as compared to $59.6
million reported for the fourth quarter of 2018. End of fourth
quarter days-on-hand channel inventory increased relative to the
third quarter 2019, which resulted in approximately $2.5 million
increase in fourth quarter 2019 net sales. For the years ended
December 31, 2019 and 2018, ACADIA reported net product sales of
$339.1 million and $223.8 million, respectively, an increase of 52%
year-over-year.
Research and Development
Research and development expenses for the fourth quarter of 2019
were $57.5 million, compared to $48.2 million for the same period
of 2018. For the years ended December 31, 2019 and 2018, research
and development expenses were $240.4 million and $187.2 million,
respectively. The increase during the 2019 periods as compared to
2018 was primarily due to development costs associated with
trofinetide and additional clinical study costs for
pimavanserin.
Selling, General and Administrative
Selling, general and administrative expenses for the fourth
quarter of 2019 were $91.9 million, compared to $74.3 million for
the same period of 2018. For the years ended December 31, 2019 and
2018, selling, general and administrative expenses were $325.6
million and $265.8 million, respectively. This increase during the
2019 periods as compared to 2018 was primarily due to increased
general and administrative expenses including charitable
contributions and personnel costs.
Net Loss
For the fourth quarter of 2019, ACADIA reported a net loss of
$53.0 million, or $0.34 per common share, compared to a net loss of
$65.5 million, or $0.50 per common share, for the same period in
2018. The net losses for the fourth quarters of 2019 and 2018
included $19.8 million and $20.4 million, respectively, of non-cash
stock-based compensation expense. For the years ended December 31,
2019, ACADIA reported a net loss of $235.3 million, or $1.60 per
common share, compared to a net loss of $245.2 million, or $1.94
per common share, for the same period in 2018. The net losses for
the years ended December 31, 2019 and 2018 included $82.2 million
and $81.6 million, respectively, of non-cash stock-based
compensation expense.
Cash and Investments
At December 31, 2019, ACADIA’s cash, cash equivalents, and
investment securities totaled $697.4 million, compared to $473.5
million at December 31, 2018. The increase was primarily due to net
proceeds of $271.5 million from ACADIA’s September 2019 public
offering of common stock as well as additional cash proceeds from
employee option exercises of $91.6 million.
2020 Financial Guidance
ACADIA’s 2020 net sales guidance reflects annual revenue growth
of approximately 34% for NUPLAZID, at the mid-point of the range.
2020 GAAP R&D guidance reflects the progression of four phase 3
studies this year. 2020 GAAP SG&A guidance reflects a similar
level of investment to 2019 in PDP with new investments in
preparing for a launch in DRP including disease-state educational
initiatives and plans for the expansion of our commercial and
medical affairs functions.
- NUPLAZID net sales are expected to be between $440 and $470
million.
- GAAP R&D is expected to be between $270 and $285
million.
- GAAP SG&A is expected to be between $440 and $460
million.
- Non-cash stock-based compensation expense is expected to be
between $90 and $100 million.
- 2020 year-end cash, cash equivalents, and investment securities
are expected to be between $470 and $500 million.
Conference Call and Webcast
Information
ACADIA management will review its fourth quarter and full year
2019 financial results and operations via conference call and
webcast today at 5:00 p.m. Eastern Time. The conference call may be
accessed by dialing 855-638-4820 for participants in the U.S. or
Canada and 443-877-4067 for international callers (reference
passcode 6692587). A
telephone replay of the conference call may be accessed through
March 11, 2020 by dialing 855-859-2056 for callers in the U.S. or
Canada and 404-537-3406 for international callers (reference
passcode 6692587). 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 through March 26, 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
dementia-related psychosis, schizophrenia, major depressive
disorder, or depressive symptoms in patients with Parkinson’s
disease. 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 also has ongoing clinical
development efforts in additional areas with significant unmet
need, including dementia-related psychosis, the negative symptoms
of schizophrenia, major depressive disorder, and Rett syndrome.
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; 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, 2018 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 December
31,
Years Ended December
31,
2019
2018
2019
2018
Revenues
Product sales, net
$
98,326
$
59,571
$
339,076
$
223,807
Total revenues
98,326
59,571
339,076
223,807
Operating expenses
Cost of product sales, license fees and
royalties (1)
5,334
4,392
19,598
18,330
Research and development (1)
57,520
48,183
240,385
187,163
Selling, general and administrative
(1)
91,871
74,271
325,638
265,758
Total operating expenses
154,725
126,846
585,621
471,251
Loss from operations
(56,399
)
(67,275
)
(246,545
)
(247,444
)
Interest income, net
3,272
1,670
11,165
5,348
Other expense
491
127
997
(1,840
)
Loss before income taxes
(52,636
)
(65,478
)
(234,383
)
(243,936
)
Income tax expense
400
14
876
1,256
Net loss
$
(53,036
)
$
(65,492
)
$
(235,259
)
$
(245,192
)
Net loss per common share, basic and
diluted
$
(0.34
)
$
(0.50
)
$
(1.60
)
$
(1.94
)
Weighted average common shares
outstanding, basic and diluted
154,492
131,627
147,199
126,583
(1) Includes the following share-based
compensation expenses
Cost of product sales, license fees and
royalties
$
592
$
838
$
2,936
$
3,863
Research and development
$
8,072
$
8,421
$
32,533
$
32,038
Selling, general and administrative
$
11,099
$
11,142
$
46,796
$
45,663
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31,
2019
December 31,
2018
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
697,429
$
473,520
Accounts receivable, net
35,781
26,090
Interest and other receivables
2,093
1,699
Inventory
6,341
4,070
Prepaid expenses
18,606
20,727
Total current assets
760,250
526,106
Property and equipment, net
3,180
3,309
Operating lease right-of-use assets
9,524
—
Intangible assets, net
2,585
4,062
Restricted cash
4,787
4,826
Other assets
2,857
1,899
Total assets
$
783,183
$
540,202
Liabilities and stockholders’
equity
Accounts payable
$
7,222
$
3,167
Accrued liabilities
67,604
56,398
Total current liabilities
74,826
59,565
Operating lease liabilities
6,361
—
Long-term liabilities
2,861
1,558
Total liabilities
84,048
61,123
Total stockholders’ equity
699,135
479,079
Total liabilities and stockholders’
equity
$
783,183
$
540,202
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200226005906/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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