Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today reported
year-over-year net revenue growth of 30 percent for the quarter
ended March 31, 2024 and accelerated its growth strategy with the
addition of a rare epilepsy franchise to its expanding pipeline of
innovative, late-stage CNS assets.
"We believe Harmony is well-positioned to become
the leading patient-focused CNS biotechnology company delivering
innovative treatments to patients living with unmet medical needs.
We have transformed our business by executing a best-in-class
launch of WAKIX in narcolepsy, advancing our pipeline through life
cycle management and new indications, and diversifying our
portfolio through strategic business development, having closed
three transactions over the past eight months,” said Jeffrey M.
Dayno, M.D., President and Chief Executive Officer of Harmony. “We
now have three late-stage orphan/rare CNS franchises, each with
potential peak sales opportunities of $1B to $2B, comprised of
eight assets advancing across thirteen development programs. We
expect our pipeline to deliver at least one new product or
indication launch every year over the next five years, with
multi-billion-dollar revenue potential extending beyond 2040. In
addition, the durable commercial success of WAKIX is currently
paving the way to surpassing $1 billion in the adult narcolepsy
market alone.”
Key Franchise Highlights:
Sleep/Wake
- WAKIX Net Revenue of $154.6 million in the first quarter of
2024, representing 30% growth over the same period in 2023.
- The average number of patients on WAKIX increased by
approximately 150 patients sequentially to approximately 6,300 for
the quarter ended March 31, 2024.
- Following a March 2024 meeting with FDA, we are moving forward
with the Idiopathic Hypersomnia (IH) program and plan to submit a
supplemental new drug application (sNDA) for pitolisant in IH in
the second half of 2024.
- Reported positive pharmacokinetic (PK) data on Next-Gen
pitolisant-based formulation 1 (NG1). Pivotal bioequivalence and
dosing optimization studies will be initiated in the fourth quarter
of 2024. PDUFA date expected in 2026. Provisional patent filed with
the potential for patent protection out to 2044.
- On track to receive PK data on Next-Gen pitolisant-based
formulation 2 (NG2) in the first half of 2024.
- Pediatric narcolepsy sNDA on track for PDUFA date of June 21,
2024.
- Initiated the Phase 3 TEMPO study in patients with Prader-Willi
syndrome (PWS) in March 2024.
- On track towards gaining pediatric exclusivity to extend WAKIX
exclusivity to September 2030 based on progress in the pediatric
narcolepsy submission and advancement of the PWS Phase 3 TEMPO
study.
- Strengthened our leadership position, and created opportunity
for long-term revenue generation, in sleep medicine with an
exclusive licensing agreement with Bioprojet to develop,
manufacture and commercialize TPM-1116, a highly potent and
selective oral orexin-2 receptor agonist that will be evaluated for
the treatment of narcolepsy and other sleep-wake disorders. Expect
to file IND by mid-2025 and initiate first-in-human studies in the
second half of 2025.
Neurobehavioral
- On track to complete patient enrollment in the Phase 3 pivotal
RECONNECT trial for Fragile X syndrome (FXS) in the first quarter
of 2025 with topline data expected in mid-2025; IP protection for
ZYN002 in FXS out to 2040.
- Phase 3 preparation ongoing for ZYN002 in 22q11.2 deletion
syndrome (22q).
Rare Epilepsy
- Acquired Epygenix Therapeutics, Inc., and establishes rare
epilepsy franchise.
- Lead product, clemizole hydrochloride (EPX-100), is a potent,
oral, centrally acting serotonin (5HT2) agonist, currently in a
pivotal registrational trial for Dravet syndrome (DS) with topline
data expected in 2026.
- Phase 3 trial for Lennox-Gastaut syndrome (LGS) expected to
initiate in the second half of 2024.
- Proven mechanism of action with potential for improved
benefit/risk profile compared to current treatment options.
- EPX-100 has been granted Orphan Drug Designation (ODD) and Rare
Pediatric Disease Designation (RPDD) for both DS and LGS by
FDA.
- IP protection for EPX-100 out to 2034.
- A second investigational product, EPX-200, is a potent, oral,
centrally acting and selective 5HT2C agonist, and is currently in
IND-enabling studies.
- EPX-200 also received ODD from FDA for DS and LGS as well as
RPDD for LGS.
First Quarter 2024 Financial
Results
Net product revenue for the quarter ended March 31,
2024, was $154.6 million, compared to $119.1 million for the same
period in 2023. The 30% growth versus the same period in 2023 is
primarily attributed to strong commercial sales of WAKIX driven by
continued organic demand tapping into a large market opportunity
(approximately 80,000 patients diagnosed with narcolepsy in the
US). The average number of patients on WAKIX increased by
approximately 150 patients sequentially to approximately 6,300 for
the quarter ended March 31, 2024.
GAAP net income for the quarter ended March 31,
2024, was $38.3 million, or $0.67 per diluted share, compared to
GAAP net income of $29.5 million, or $0.48 per diluted share, for
the same period in 2023. Non-GAAP adjusted net income was $50.7
million, or $0.88 per diluted share, for the quarter ended March
31, 2024, compared to Non-GAAP adjusted net income of $40.1
million, or $0.66 per diluted share, for the same period in
2023.
Reconciliations of applicable GAAP financial
measures to Non-GAAP financial measures are included at the end of
this press release.
Harmony’s operating expenses include the
following:
- Research and Development expenses were $22.2 million in the
first quarter of 2024, as compared to $13.3 million for the same
quarter in 2023, representing a 67% increase;
- Sales and Marketing expenses were $27.2 million in the first
quarter of 2024, as compared to $22.6 million for the same quarter
in 2023, representing a 21% increase;
- General and Administrative expenses were $25.7 million in the
first quarter of 2024, as compared to $22.1 million for the same
quarter in 2023, representing a 16% increase; and
- Total Operating Expenses were $75.1 million in the first
quarter of 2024, as compared to $57.9 million for the same quarter
in 2023, representing a 30% increase.
As of March 31, 2024, Harmony had cash, cash
equivalents and investments of $453.6 million, compared
to $425.6 million as of December 31, 2023.
Reiterates 2024 Net Product Revenue
Guidance
Expect full year 2024 net product revenue of $700
million to $720 million.
Share Repurchase Program
The remaining amount of common stock authorized for
repurchases as of March 31, 2024, was $150 million.
Conference Call Today at 8:30 a.m.
ET We are hosting our first quarter 2024 financial results
conference call and webcast today at 8:30 a.m. Eastern Time. The
live and replay webcast of the call will be available on the
investor relations page of our website at
https://ir.harmonybiosciences.com/. To participate in the live call
by phone, dial (800) 579-2543 (domestic) or +1 (785) 424- 1789
(international), and reference passcode HRMYQ124.
Non-GAAP Financial MeasuresIn
addition to our GAAP results, we present certain Non-GAAP metrics
including Non-GAAP adjusted net income and Non-GAAP adjusted net
income per share, which we believe provides important supplemental
information to management and investors regarding our performance.
These measurements are not a substitute for GAAP measurements, and
the manner in which we calculate Non-GAAP adjusted net income and
Non-GAAP adjusted net income per share may not be identical to the
manner in which other companies calculate adjusted net income and
adjusted net income per share. We use these Non-GAAP measurements
as an aid in monitoring our financial performance from
quarter-to-quarter and year-to-year and for benchmarking against
comparable companies.
Non-GAAP financial measures should not be
considered in isolation or as a substitute for comparable GAAP
measures; should be read in conjunction with our consolidated
financial statements prepared in accordance with GAAP; have no
standardized meaning prescribed by GAAP; and are not prepared under
any comprehensive set of accounting rules or principles. In
addition, from time to time in the future there may be other items
that we may exclude for purposes of our Non-GAAP financial
measures; and we may in the future cease to exclude items that we
have historically excluded for purposes of our Non-GAAP financial
measures.
About WAKIX® (pitolisant)
TabletsWAKIX, 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 UsageWAKIX is
indicated for the treatment of excessive daytime sleepiness or
cataplexy in adult patients with narcolepsy.
Important Safety Information
ContraindicationsWAKIX 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 PrecautionsWAKIX
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 ReactionsIn the
placebo-controlled clinical trials conducted in patients with
narcolepsy with or without cataplexy, the most common adverse
reactions (≥5% and 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 infection,
musculoskeletal pain, heart rate increased, hallucinations,
irritability, abdominal pain, sleep disturbance, decreased
appetite, cataplexy, dry mouth, and rash.
Drug InteractionsConcomitant
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 PopulationsWAKIX
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 NarcolepsyNarcolepsy is a
rare, chronic, debilitating neurological disease of sleep-wake
state instability that impacts approximately 170,000 Americans and
is primarily characterized by excessive daytime sleepiness (EDS)
and cataplexy – its two cardinal symptoms – along with other
manifestations of REM sleep dysregulation (hallucinations and sleep
paralysis), which intrude into wakefulness. EDS is the inability to
stay awake and alert during the day and is the symptom that is
present in all people living with narcolepsy. In most patients,
narcolepsy is caused by the loss of hypocretin/orexin, a
neuropeptide in the brain that supports sleep-wake state stability.
This disease affects men and women equally, with typical symptom
onset in adolescence or young adulthood; however, it can take up to
a decade to be properly diagnosed.
About Idiopathic
HypersomniaIdiopathic Hypersomnia (IH) is a rare and
chronic neurological disease that is characterized
by excessive daytime sleepiness (EDS) despite sufficient or
even long sleep time. EDS in IH cannot be alleviated by naps,
longer sleep or more efficient sleep. People living with IH
experience significant EDS along with the symptoms of sleep inertia
(prolonged difficulty waking up from sleep) and 'brain fog'
(impaired cognition, attention, and alertness). The cause of IH is
unknown, but it is likely due to alterations in areas of
the brain that stabilize states of sleep and wakefulness.
IH is one of the central disorders of hypersomnolence and, like
narcolepsy, is a debilitating sleep disorder that can result in
significant disruption in daily functioning.
About Prader-Willi SyndromePWS is
an orphan/rare, genetic neurological disorder with many of the
symptoms resulting from hypothalamic dysfunction. The hypothalamus
is the part of the brain that controls both sleep-wake state
stability and signals that mediate the balance between hunger and
satiety, resulting in two of the main symptoms in patients with
PWS; EDS and hyperphagia (an intense persistent sensation of hunger
accompanied by food preoccupations, an extreme drive to consume
food, food-related behavior problems, and a lack of normal
satiety). Other features include low muscle tone, short stature,
behavioral problems, and cognitive impairment. Approximately 15,000
to 20,000 people in the U.S. live with PWS, and over half of them
experience EDS and the majority of them have behavioral
disturbances.
About ZYN002ZYN002 is the
first-and-only pharmaceutically manufactured synthetic cannabidiol
devoid of THC and formulated as a patent-protected
permeation-enhanced gel for transdermal delivery through the skin
and into the circulatory system. The product is manufactured
through a synthetic process in a cGMP facility and is not extracted
from the cannabis plant. ZYN002 does not contain THC, the compound
that causes the euphoric effect of cannabis, and has the potential
to be a nonscheduled product if approved. Cannabidiol, the active
ingredient in ZYN002, has been granted orphan drug designation by
the United States Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) for the treatment of FXS and for
the treatment of 22q. Additionally, ZYN002 has received FDA Fast
Track designation for the treatment of behavioral symptoms in
patients with FXS.
About Fragile X SyndromeFragile X
syndrome (FXS) is a rare genetic disorder that is the leading known
cause of both inherited intellectual disability and autism spectrum
disorder. The disorder negatively affects synaptic function,
plasticity and neuronal connections, and results in a spectrum of
intellectual disabilities and behavioral symptoms, such as social
avoidance and irritability. While the exact prevalence is unknown,
upwards of 80,000 patients in the U.S. and 121,000 patients in the
European Union and the UK are believed to have FXS, based on FXS
prevalence estimates of approximately 1 in 4,000 to 7,000 in males
and approximately 1 in 8,000 to 11,000 in females. There is a
significant unmet medical need in patients living with FXS as there
are currently no FDA approved treatments for this disorder.
FXS is caused by a mutation in FMR1, a gene which
modulates a number of systems, including the endocannabinoid
system, and most critically, codes for a protein called FMRP. The
FMR1 mutation manifests as multiple repeats of a DNA segment, known
as the CGG triplet repeat, resulting in deficiency or lack of FMRP.
FMRP helps regulate the production of other proteins and plays a
role in the development of synapses, which are critical for
relaying nerve impulses, and in regulating synaptic plasticity. In
people with full mutation of the FMR1 gene, the CGG segment is
repeated more than 200 times, and in most cases causes the gene to
not function. Methylation of the FMR1 gene also plays a role in
determining functionality of the gene. In approximately 60% of
patients with FXS, who have complete methylation of the FMR1 gene,
no FMRP is produced, resulting in dysregulation of the systems
modulated by FMRP.
About 22q11.2 Deletion
Syndrome22q11.2 deletion syndrome (22q) is a disorder
caused by a small missing piece of the 22nd chromosome. The
deletion occurs near the middle of the chromosome at a location
designated q11.2. It is considered a mid-line condition, with
physical symptoms including characteristic palate abnormalities,
heart defects, immune dysfunction, and esophageal/ GI issues, as
well as debilitating neuropsychiatric and behavioral symptoms,
including anxiety, social withdrawal, ADHD, cognitive impairment
and autism spectrum disorder. It is estimated that 22q occurs in
one in 4,000 live births, suggesting that there are approximately
80,000 people living with 22q in the U.S. and 129,000 in the
European Union and the UK. Patients with 22q deletion syndrome are
managed by multidisciplinary care providers, and there are
currently no FDA approved treatments for this disorder.
About Clemizole hydrochloride
(EPX-100)EPX-100, clemizole hydrochloride, is under
development for the treatment of Dravet syndrome (DS) and
Lennox-Gastaut syndrome (LGS). EPX-100 acts by targeting central
5-hydroxytryptamine receptors to modulate serotonin signaling. The
drug candidate is administered orally twice a day in a liquid
formulation and has been developed based on a proprietary
phenotype-based zebrafish drug screening platform.1 DS is caused by
a loss of function mutation in the SCN1A gene, and scn1 mutant
zebrafish replicate the genetic etiology and phenotype observed in
the majority of DS patients. The scn1Lab mutant zebrafish model
that expresses voltage gated sodium channels has been used for
high-throughput screening of compounds that modulate Nav1.1 in the
central nervous system.
About Dravet SyndromeDravet
syndrome (DS) is a severe and progressive epileptic encephalopathy
that begins in infancy and causes significant impact on patient
functioning. DS begins in the first year of life and is
characterized by high seizure frequency and severity, intellectual
disability, and a risk of sudden unexpected death in epilepsy.1
Approximately 85% of Dravet Syndrome cases are caused by de novo
loss-of-function (LOF) mutations in a voltage-gated sodium channel
gene, SCN1A1.2 DS has an estimated incidence rate of 1:15,700.3
About Lennox-Gastaut Syndrome
Lennox-Gastaut Syndrome (LGS) is a rare and drug-resistant
epileptic encephalopathy characterized by onset in children between
3-5 years of age. The underlying cause of LGS is unknown and can be
related to a wide range of factors including genetic differences
and structural differences in the brain.2,4 As a result, patients
experience multiple seizure types, including atonic seizures, and
developmental, cognitive, and behavioral issues.3 LGS affects
approximately 48,000 patients in the U.S. 5
(1) EpyGenix Company Presentation:
https://www.epygenix.com/news(2) EpyGenixPoster:
https://www.epygenix.com/_files/ugd/4ad619_2db63a277738444c85e70a47b816a67c.pdf (3)
Wu, E., et. al. (2015). Incidence of Dravet Syndrome in a US
Population. Pediatrics 136(5): 1310-e1315. doi:
10.1542/peds.2015-1807.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4621800/(4)
https://www.epygenix.com/rare-genetic-epilepsy(5)
https://www.lgsfoundation.org/about-lgs-2/how-many-people-have-lgs/
About Harmony BiosciencesAt
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 full year 2024 net
product revenue, expectations for the growth and value of WAKIX,
plans to submit an sNDA for pitolisant in idiopathic hypersomnia;
our future results of operations and financial position, business
strategy, products, prospective products, product approvals, the
plans and objectives of management for future operations and future
results of anticipated products. 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 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 plans to explore the therapeutic potential of pitolisant in
additional indications; our ongoing and planned clinical trials;
our ability to expand the scope of our license agreements with
Bioprojet Société Civile de Recherche (“Bioprojet”); 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 other
product candidates; our estimates regarding expenses, future
revenue, capital requirements and additional financing needs; our
ability to identify, acquire and integrate 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 22, 2024, 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 HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS) (In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
March 31, |
|
|
2024 |
|
|
2023 |
|
Net product revenue |
|
$ |
154,615 |
|
|
$ |
119,126 |
|
Cost of product sold |
|
|
27,484 |
|
|
|
20,780 |
|
Gross profit |
|
|
127,131 |
|
|
|
98,346 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
22,189 |
|
|
|
13,289 |
|
Sales and marketing |
|
|
27,233 |
|
|
|
22,572 |
|
General and administrative |
|
|
25,676 |
|
|
|
22,062 |
|
Total operating expenses |
|
|
75,098 |
|
|
|
57,923 |
|
Operating income |
|
|
52,033 |
|
|
|
40,423 |
|
Other expense (income),
net |
|
|
(141 |
) |
|
|
2 |
|
Interest expense |
|
|
(4,535 |
) |
|
|
(5,731 |
) |
Interest income |
|
|
4,428 |
|
|
|
3,086 |
|
Income before income
taxes |
|
|
51,785 |
|
|
|
37,780 |
|
Income tax benefit
(expense) |
|
|
(13,451 |
) |
|
|
(8,295 |
) |
Net income |
|
$ |
38,334 |
|
|
$ |
29,485 |
|
EARNINGS PER SHARE: |
|
|
|
|
|
|
Basic |
|
$ |
0.68 |
|
|
$ |
0.49 |
|
Diluted |
|
$ |
0.67 |
|
|
$ |
0.48 |
|
Weighted average number of shares of common stock - basic |
|
|
56,771,251 |
|
|
|
59,732,157 |
|
Weighted average number of shares of common stock - diluted |
|
|
57,597,627 |
|
|
|
61,221,511 |
|
HARMONY BIOSCIENCES HOLDINGS, INC. AND
SUBSIDIARIESCONSOLIDATED BALANCE
SHEETS(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2024 |
|
|
2023 |
|
ASSETS |
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
332,981 |
|
|
$ |
311,660 |
|
Investments, short-term |
|
39,369 |
|
|
|
41,800 |
|
Trade receivables, net |
|
79,719 |
|
|
|
74,140 |
|
Inventory, net |
|
5,857 |
|
|
|
5,363 |
|
Prepaid expenses |
|
12,894 |
|
|
|
12,570 |
|
Other current assets |
|
8,683 |
|
|
|
5,537 |
|
Total current assets |
|
479,503 |
|
|
|
451,070 |
|
NONCURRENT ASSETS: |
|
|
|
|
Property and equipment, net |
|
213 |
|
|
|
371 |
|
Restricted cash |
|
270 |
|
|
|
270 |
|
Investments, long-term |
|
81,244 |
|
|
|
72,169 |
|
Intangible assets, net |
|
131,147 |
|
|
|
137,108 |
|
Deferred tax asset |
|
147,639 |
|
|
|
144,162 |
|
Other noncurrent assets |
|
6,969 |
|
|
|
6,298 |
|
Total noncurrent assets |
|
367,482 |
|
|
|
360,378 |
|
TOTAL ASSETS |
|
846,985 |
|
|
$ |
811,448 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
Trade payables |
|
15,144 |
|
|
$ |
17,730 |
|
Accrued compensation |
|
7,317 |
|
|
|
23,747 |
|
Accrued expenses |
|
91,699 |
|
|
|
99,494 |
|
Current portion of long-term debt |
|
15,000 |
|
|
|
15,000 |
|
Other current liabilities |
|
25,093 |
|
|
|
7,810 |
|
Total current liabilities |
|
154,253 |
|
|
|
163,781 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
Long-term debt, net |
|
174,996 |
|
|
|
178,566 |
|
Other noncurrent liabilities |
|
2,342 |
|
|
|
2,109 |
|
Total noncurrent liabilities |
|
177,338 |
|
|
|
180,675 |
|
TOTAL LIABILITIES |
|
331,591 |
|
|
|
344,456 |
|
COMMITMENTS AND CONTINGENCIES (Note 13) |
|
|
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
Common stock—$0.00001 par value; 500,000,000 shares authorized at
March 31, 2024 and December 31, 2023,
respectively; 56,791,214 and 56,769,081 shares issued and
outstanding at March 31, 2024 and
December 31, 2023, respectively |
|
1 |
|
|
|
1 |
|
Additional paid in capital |
|
620,507 |
|
|
|
610,266 |
|
Accumulated other comprehensive (loss) income |
|
(171 |
) |
|
|
2 |
|
Accumulated deficit |
|
(104,943 |
) |
|
|
(143,277 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
515,394 |
|
|
|
466,992 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
846,985 |
|
|
$ |
811,448 |
|
HARMONY BIOSCIENCES HOLDINGS,
INC.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL
RESULTS(In thousands except share and per share
data) |
|
|
|
Three Months Ended |
|
|
March 31, |
|
March 31, |
|
|
2024 |
|
|
2023 |
|
GAAP net income |
|
$ |
38,334 |
|
|
$ |
29,485 |
|
Non-GAAP Adjustments: |
|
|
|
|
|
|
Non-cash interest expense (1) |
|
|
180 |
|
|
|
416 |
|
Depreciation |
|
|
163 |
|
|
|
103 |
|
Amortization (2) |
|
|
5,961 |
|
|
|
5,961 |
|
Stock-based compensation expense |
|
|
10,434 |
|
|
|
6,561 |
|
Licensing fees and milestone payments (3) |
|
|
- |
|
|
|
750 |
|
Income tax effect related to non-GAAP adjustments (4) |
|
|
(4,350 |
) |
|
|
(2,538 |
) |
Non-GAAP adjusted net income |
|
$ |
50,722 |
|
|
$ |
40,738 |
|
|
|
|
|
|
|
|
GAAP reported net
income per diluted share |
|
$ |
0.67 |
|
|
$ |
0.48 |
|
Non-GAAP adjusted net income
per diluted share |
|
$ |
0.88 |
|
|
$ |
0.67 |
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock used in non-GAAP diluted per share |
|
|
57,597,627 |
|
|
|
61,221,511 |
|
(1) Includes amortization of deferred finance charges.(2)
Includes amortization of intangible asset related to WAKIX.(3)
Includes milestone payment related to HBS102 preclinical milestone
in March 2023.(4) Calculated using the reported effective tax rate
for the periods presented less impact of valuation allowance
release and discrete items.
Harmony Biosciences Investor Contact:Luis
Sanay, CFA445-235-8386lsanay@harmonybiosciences.com
Harmony Biosciences Media Contact:Cate
McCanless202-641-6086cmccanless@harmonybiosciences.com
Harmony Biosciences (NASDAQ:HRMY)
Historical Stock Chart
From May 2024 to Jun 2024
Harmony Biosciences (NASDAQ:HRMY)
Historical Stock Chart
From Jun 2023 to Jun 2024