- Full year 2020 net sales grew to $441.8
million, a 30% increase over 2019
- Upcoming PDUFA action date of April 3, 2021
for supplemental New Drug Application for pimavanserin for the
treatment of hallucinations and delusions associated with
dementia-related psychosis
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced
financial results for the fourth quarter and full year ended
December 31, 2020.
“Acadia delivered strong financial results in the fourth quarter
and full year 2020, driven by robust sales of NUPLAZID in
Parkinson’s disease psychosis. Additionally, we made significant
advancements in two Phase 3 programs and further expanded our
pipeline in pain and neuropsychiatry through strategic business
development,” said Steve Davis, Chief Executive Officer. “In 2021,
we are focused on delivering continued growth of NUPLAZID, the
upcoming potential approval and launch of pimavanserin for
dementia-related psychosis and advancing our business development
strategy.”
Company Highlights
- Upcoming PDUFA (Prescription Drug User Fee Act) date of April
3, 2021 for supplemental New Drug Application for pimavanserin for
the treatment of hallucinations and delusions associated with
dementia-related psychosis.
- Top-line results from Phase 3 LAVENDER study evaluating
trofinetide for the treatment of Rett syndrome expected in the
fourth quarter of 2021.
- Two Phase 2 clinical studies evaluating ACP-044, a novel,
first-in-class, orally administered, non-opioid analgesic, in acute
and chronic pain to commence in first half of 2021. A bunionectomy
study is expected to initiate in the first quarter of 2021 and an
osteoarthritis study is expected to initiate in the second quarter
of 2021.
- In November 2020, the FDA approved a label update to allow the
NUPLAZID capsule to be sprinkled on certain foods. This is an
important feature for patients who take oral medications and may
have difficulty swallowing; a potential issue for Parkinson’s
disease patients and in the elderly in general.
- Kathie Bishop, Ph.D., joined Acadia as Senior Vice President,
Head of Rare Disease and Diann Potestio joined Acadia as Senior
Vice President, Market Access, Reimbursement and Channel
Strategy.
Financial Results
Revenue Net sales of NUPLAZID® (pimavanserin) were $121.0
million for the fourth quarter of 2020, an increase of 23% as
compared to $98.3 million reported for the fourth quarter of 2019.
For the years ended December 31, 2020 and 2019, Acadia reported net
product sales of $441.8 million and $339.1 million, respectively,
an increase of 30% year-over-year.
Research and Development Research and development expenses for
the fourth quarter of 2020 were $62.1 million, compared to $57.5
million for the same period of 2019. For the years ended December
31, 2020 and 2019, research and development expenses were $319.1
million and $240.4 million, respectively. The increase in full year
2020 was primarily due to the upfront expenses of $52.8 million
related to the acquisition of CerSci Therapeutics and a $10.0
million upfront payment to Vanderbilt University related to the
license agreement and collaboration for novel therapeutic programs
targeting muscarinic M1 receptors.
Selling, General and Administrative Selling, general and
administrative expenses for the fourth quarter of 2020 were $120.8
million, compared to $91.9 million for the same period of 2019. For
the years ended December 31, 2020 and 2019, selling, general and
administrative expenses were $388.7 million and $325.6 million,
respectively. This increase during the 2020 period as compared to
2019 was primarily due to increased advertising and promotional
costs, dementia-related psychosis launch preparation expenses, as
well as an increase in personnel and related costs.
Net Loss For the fourth quarter of 2020, Acadia reported a net
loss of $66.8 million, or $0.42 per common share, compared to a net
loss of $53.0 million, or $0.34 per common share, for the same
period in 2019. The net losses for the fourth quarters of 2020 and
2019 included $21.2 million and $19.8 million, respectively, of
non-cash stock-based compensation expense. For the year ended
December 31, 2020, Acadia reported a net loss of $281.6 million, or
$1.79 per common share, compared to a net loss of $235.3 million,
or $1.60 per common share, for the same period in 2019. The net
losses for the years ended December 31, 2020 and 2019 included
$84.4 million and $82.3 million, respectively, of non-cash
stock-based compensation expense.
Cash and Investments At December 31, 2020, Acadia’s cash, cash
equivalents, and investment securities totaled $632.0 million,
compared to $697.4 million at December 31, 2019.
2021 Financial Guidance
- Net sales guidance for NUPLAZID in Parkinson’s disease
psychosis (PDP) of $510 to $550 million. As this is the potential
launch year for dementia-related psychosis (DRP), the Company is
not including revenue projections for DRP in 2021 net sales
guidance.
- GAAP R&D guidance of $300 to $320 million reflects the
progression of candidates in five clinical indications this year.
This guidance includes approximately $30 million of share-based
compensation expense.
- GAAP SG&A guidance of $560 to $590 million reflects a
similar level of investment to 2020 in PDP activities, together
with additional investments associated with a potential DRP launch.
This guidance includes approximately $60 million of share-based
compensation expense.
Conference Call and Webcast
Information Acadia management will review its fourth quarter and
full year 2020 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 9576845). A telephone replay of the conference
call may be accessed through March 10, 2021 by dialing 855-859-2056
for callers in the United States or Canada and 404-537-3406 for
international callers (reference passcode 9576845). 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 24, 2021.
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 trailblazing
breakthroughs in neuroscience to elevate life. For more than 25
years we have been working at the forefront of healthcare to bring
vital solutions to people who need them most. We developed and
commercialized the first and only approved therapy for
hallucinations and delusions associated with Parkinson’s disease
psychosis. Our late-stage development efforts are focused on
dementia-related psychosis, negative symptoms of schizophrenia and
Rett syndrome, and in early-stage clinical research we are
exploring novel approaches to pain management, and cognition and
neuropsychiatric symptoms in central nervous system disorders. For
more information, visit us at www.acadia-pharm.com and follow us on
LinkedIn.
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 2021 NUPLAZID net sales for
Parkinson’s disease psychosis only 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 2021, 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 December
31,
Years Ended December
31,
2020
2019
2020
2019
Revenues
Product sales, net
$
121,007
$
98,326
$
441,755
$
339,076
Total revenues
121,007
98,326
441,755
339,076
Operating expenses
Cost of product sales, license fees and
royalties (1)
5,301
5,334
20,550
19,598
Research and development (1)
62,116
57,520
319,130
240,385
Selling, general and administrative
(1)
120,752
91,871
388,661
325,638
Total operating expenses
188,169
154,725
728,341
585,621
Loss from operations
(67,162
)
(56,399
)
(286,586
)
(246,545
)
Interest income, net
554
3,272
6,610
11,165
Other income (expense)
265
491
(997
)
997
Loss before income taxes
(66,343
)
(52,636
)
(280,973
)
(234,383
)
Income tax (benefit) expense
417
400
611
876
Net loss
$
(66,760
)
$
(53,036
)
$
(281,584
)
$
(235,259
)
Net loss per common share, basic and
diluted
$
(0.42
)
$
(0.34
)
$
(1.79
)
$
(1.60
)
Weighted average common shares
outstanding, basic and diluted
159,263
154,492
157,331
147,199
(1) Includes the following share-based
compensation expenses
Cost of product sales, license fees and
royalties
$
545
$
592
$
2,632
$
2,936
Research and development
$
7,669
$
8,072
$
31,314
$
32,533
Selling, general and administrative
$
12,981
$
11,099
$
50,476
$
46,796
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31,
2020
December 31,
2019
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
631,958
$
697,429
Accounts receivable, net
48,247
35,781
Interest and other receivables
2,035
2,093
Inventory
9,682
6,341
Prepaid expenses
25,694
18,606
Total current assets
717,616
760,250
Property and equipment, net
9,161
3,180
Operating lease right-of-use assets
47,283
9,524
Intangible assets, net
1,108
2,585
Restricted cash
5,770
4,787
Other assets
1,678
2,857
Total assets
$
782,616
$
783,183
Liabilities and stockholders’
equity
Accounts payable
$
8,493
$
7,222
Accrued liabilities
97,474
67,604
Total current liabilities
105,967
74,826
Operating lease liabilities
44,460
6,361
Long-term liabilities
5,180
2,861
Total liabilities
155,607
84,048
Total stockholders’ equity
627,009
699,135
Total liabilities and stockholders’
equity
$
782,616
$
783,183
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210224006043/en/
Media Contact: Acadia Pharmaceuticals Inc. Eric Endicott (858)
914-7161 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Sep 2023 to Sep 2024