WAKIX® (pitolisant) Preliminary Net
Revenue of ~$168 Million for Fourth
Quarter and ~$582 Million for Full
Year 2023; Representing Growth of ~31% and ~33%,
Respectively
Average Number of Patients on WAKIX
Increased to ~6,150
2024 Net Product Revenue Projected Between
$700 -$720
Million
$50 Million
Common Stock Repurchase in Fourth Quarter Bringing 2023 Total to
$100 Million; Expect to Continue
Opportunistic Share Repurchases in 2024
PLYMOUTH
MEETING, Pa., Jan. 8, 2024
/PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY)
today reported preliminary, unaudited fourth quarter and full year
2023 net product revenue growth of more than 30 percent.
The company also provided 2024 net product revenue guidance of
$700 to $720
million and outlined key priorities in advance of its
presentation at the 42nd Annual J.P. Morgan Healthcare
Conference on Wednesday, January 10,
2024 at 5:15 p.m. PT /
8:15 p.m. ET.
"In 2023, Harmony advanced our clinical development programs and
diversified our portfolio while achieving net revenue of
approximately $582 million," said
Jeffrey M. Dayno, M.D., Harmony President and CEO. "We enter 2024 poised
to generate up to $720 million in net
revenue and are well on our way toward a one
billion dollar plus opportunity for WAKIX in adult
narcolepsy alone. Leveraging our strong cash position, as well as
our expertise in clinical development and commercial execution, we
will continue to advance our growth strategy by adding new products
to build out a robust pipeline."
Fourth Quarter and Full Year 2023 Net Product Revenue
(Preliminary and Unaudited)
- Preliminary, unaudited net product revenue for the quarter
ended December 31, 2023, was
approximately $168 million, compared
to $128.3 million for the same period
in 2022, representing ~31% growth
- Preliminary, unaudited net product revenue for the full year
ended December 31, 2023, was
approximately $582 million, compared
to $437.9 million for the same period
in 2022, representing ~33% growth
- The average number of patients on WAKIX increased by
approximately 350 sequentially to approximately 6,150 for the
quarter ended December 31, 2023
2024 Key Priorities
- Continued Strong Growth for WAKIX in Adult
Narcolepsy
Drive commercial strategy to achieve
Net Revenue >$700 million
Grow average number of patients on
WAKIX to ~7,000
Increase educational outreach to
drive continued growth in depth and breadth
of
prescriber base and patient interest in WAKIX
- Advance and Expand the Pipeline
Report pharmacokinetic (PK) data on
new pitolisant-based formulations in 1H
2024
Drive patient enrollment in the Phase
3 pivotal RECONNECT trial for Fragile X
syndrome
Initiate Phase 3 TEMPO study in
Prader-Willi syndrome in Q1 2024
FDA meeting request submitted to
discuss Idiopathic Hypersomnia path
forward; anticipate meeting in
Q1 2024
Complete review of positive Myotonic
Dystrophy Type 1 Phase 2 POC data in
EDS and fatigue; assess
opportunity
- Disciplined Capital Allocation to Maximize Shareholder
Value
Actively pursue business development
opportunities to expand our pipeline
and diversify our portfolio
Continued opportunistic execution of
share repurchase program
2024 Net Product Revenue Guidance
- Expect full year 2024 net product revenue of $700 million to $720
million
Share Repurchase Program
- Repurchased ~1.8 million shares of common stock for
$50 million in fourth quarter
2023
- Repurchased ~3.2 million shares of common stock for
$100 million in full year 2023
- Remaining share repurchase program authorization of
$150 million. Expect to continue
opportunistic repurchase of shares.
The financial information included in this press release is
preliminary, unaudited, and subject to change. It does not present
all the information necessary for an understanding of the company's
financial results for the fourth quarter or full year 2023.
About WAKIX® (pitolisant) Tablets
WAKIX, a
first-in-class medication, is approved by the U.S. Food and Drug
Administration for the treatment of excessive daytime sleepiness or
cataplexy in adult patients with narcolepsy and has been
commercially available in the U.S. since Q4 2019. It was
granted orphan drug designation for the treatment of narcolepsy in
2010, and breakthrough therapy designation for the treatment of
cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor
antagonist/inverse agonist. The mechanism of action of WAKIX is
unclear; however, its efficacy could be mediated through its
activity at H₃ receptors, thereby increasing the synthesis and
release of histamine, a wake promoting neurotransmitter. WAKIX was
designed and developed by Bioprojet (France). Harmony has an exclusive license from
Bioprojet to develop, manufacture and commercialize pitolisant in
the United States.
Indications and Usage
WAKIX is indicated for the
treatment of excessive daytime sleepiness or cataplexy in adult
patients with narcolepsy.
Important Safety Information
Contraindications
WAKIX is contraindicated in patients
with known hypersensitivity to pitolisant or any component of the
formulation. Anaphylaxis has been reported. WAKIX is also
contraindicated in patients with severe hepatic impairment.
Warnings and Precautions
WAKIX prolongs the QT
interval; avoid use of WAKIX in patients with known QT prolongation
or in combination with other drugs known to prolong the QT
interval. Avoid use in patients with a history of cardiac
arrhythmias, as well as other circumstances that may increase the
risk of the occurrence of torsade de pointes or sudden death,
including symptomatic bradycardia, hypokalemia or hypomagnesemia,
and the presence of congenital prolongation of the QT
interval.
The risk of QT prolongation may be greater in patients with
hepatic or renal impairment due to higher concentrations of
pitolisant; monitor these patients for increased QTc. Dosage
modification is recommended in patients with moderate hepatic
impairment and moderate or severe renal impairment (see full
prescribing information). WAKIX is not recommended in patients with
end-stage renal disease (ESRD).
Adverse Reactions
In the placebo-controlled clinical
trials conducted in patients with narcolepsy with or without
cataplexy, the most common adverse reactions (≥5% and at least
twice placebo) for WAKIX were insomnia (6%), nausea (6%), and
anxiety (5%). Other adverse reactions that occurred at ≥2% and more
frequently than in patients treated with placebo included headache,
upper respiratory tract infection, musculoskeletal pain, heart rate
increased, hallucinations, irritability, abdominal pain, sleep
disturbance, decreased appetite, cataplexy, dry mouth, and
rash.
Drug Interactions
Concomitant administration of WAKIX
with strong CYP2D6 inhibitors increases pitolisant exposure by
2.2-fold. Reduce the dose of WAKIX by half.
Concomitant use of WAKIX with strong CYP3A4 inducers decreases
exposure of pitolisant by 50%. Dosage adjustments may be required
(see full prescribing information).
H1 receptor antagonists that cross the blood-brain barrier may
reduce the effectiveness of WAKIX. Patients should avoid centrally
acting H1 receptor antagonists.
WAKIX is a borderline/weak inducer of CYP3A4. Therefore, reduced
effectiveness of sensitive CYP3A4 substrates may occur when used
concomitantly with WAKIX. The effectiveness of hormonal
contraceptives may be reduced when used with WAKIX and
effectiveness may be reduced for 21 days after discontinuation of
therapy.
Use in Specific Populations
WAKIX may reduce the
effectiveness of hormonal contraceptives. Patients using hormonal
contraception should be advised to use an alternative non-hormonal
contraceptive method during treatment with WAKIX and for at least
21 days after discontinuing treatment.
There is a pregnancy exposure registry that monitors pregnancy
outcomes in women who are exposed to WAKIX during pregnancy.
Patients should be encouraged to enroll in the WAKIX pregnancy
registry if they become pregnant. To enroll or obtain information
from the registry, patients can call 1-800-833-7460. The
safety and effectiveness of WAKIX have not been established in
patients less than 18 years of age.
WAKIX is extensively metabolized by the liver. WAKIX is
contraindicated in patients with severe hepatic impairment. Dosage
adjustment is required in patients with moderate hepatic
impairment.
WAKIX is not recommended in patients with end-stage renal
disease. Dosage adjustment of WAKIX is recommended in patients with
moderate or severe renal impairment.
Dosage reduction is recommended in patients known to be poor
CYP2D6 metabolizers; these patients have higher concentrations of
WAKIX than normal CYP2D6 metabolizers.
Please see the Full Prescribing Information for
WAKIX for more information.
To report suspected adverse reactions, contact Harmony
Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
About Harmony Biosciences
At Harmony Biosciences, we
specialize in developing and delivering treatments for rare
neurological diseases that others often overlook. We believe that
where empathy and innovation meet, a better life can begin for
people living with neurological diseases. Established by Paragon
Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, PA, our team of experts from
a wide variety of disciplines and experiences is driven by our
shared conviction that innovative science translates into
therapeutic possibilities for our patients, who are at the heart of
everything we do. For more information, please visit
www.harmonybiosciences.com.
Forward-Looking Statements
This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including statements regarding our product WAKIX and our future
capabilities following the acquisition of Zynerba. These statements
are neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, the following: our commercialization efforts
and strategy for WAKIX; the rate and degree of market acceptance
and clinical utility of WAKIX, pitolisant in additional
indications, if approved, and any other product candidates we may
develop or acquire, if approved; our research and development
plans, including our development activities with Bioprojet, and
plans to explore the therapeutic potential of pitolisant in
additional indications; our ongoing and planned clinical trials;
the availability of favorable insurance coverage and reimbursement
for WAKIX; the timing of and our ability to obtain regulatory
approvals for pitolisant for other indications as well as any of
our product candidates, including those we are developing with
Bioprojet; our failure to achieve the potential benefits of the
2022 LCA with Bioprojet; our ability to recognize the intended
benefits of our acquisition of Zynerba Pharmaceuticals; our
estimates regarding expenses, future revenue, capital requirements
and needs for additional financing; our ability to identify
additional products or product candidates with significant
commercial potential that are consistent with our commercial
objectives; our commercialization, marketing and manufacturing
capabilities and strategy; significant competition in our industry;
our intellectual property position; loss or retirement of key
members of management; failure to successfully execute our growth
strategy, including any delays in our planned future growth; our
failure to maintain effective internal controls; the impact of
government laws and regulations; volatility and fluctuations in the
price of our common stock; the significant costs and required
management time as a result of operating as a public company; the
fact that the price of Harmony's common stock may be volatile and
fluctuate substantially; statements related to our intended share
repurchases and repurchase timeframe and the significant costs and
required management time as a result of operating as a public
company. These and other important factors discussed under the
caption "Risk Factors" in our Annual Report on Form 10-K filed with
the Securities and Exchange Commission (the "SEC") on February 21, 2023, and our other filings with the
SEC could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management's
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, we disclaim any obligation to do so, even if subsequent
events cause our views to change.
Harmony Biosciences Investor Contact:
Luis Sanay, CFA
445-235-8386
lsanay@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/harmony-biosciences-preliminary-unaudited-fourth-quarter-and-full-year-2023-net-product-revenue-increases-more-than-30-percent-provides-2024-net-product-revenue-guidance-302027856.html
SOURCE Harmony Biosciences