Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today reported
net revenue growth of more than 30% for the fourth quarter and full
year ended December 31, 2023.
“Harmony delivered another year of outstanding performance in
2023, with continued strong growth for WAKIX, demonstrating its
durability going into year five on the market,” stated Jeffrey M.
Dayno, M.D., President and Chief Executive Officer of Harmony. “In
addition to our strong commercial execution, we advanced all our
clinical development programs for pitolisant, moved the
Next-Generation formulations of pitolisant into the clinic,
expanded our pipeline and diversified our portfolio with the
acquisition of Zynerba and the ongoing Phase 3 trial in Fragile X
syndrome. Harmony continues to be a growth story and we look
forward to continued strong execution in 2024.”
Key Business Updates
- FDA granted priority review of supplemental new drug
application (sNDA) for WAKIX in pediatric narcolepsy; PDUFA date of
June 21, 2024
- Meeting with the FDA to discuss Idiopathic Hypersomnia (IH)
development program scheduled for March 2024
- FDA granted Orphan Drug designation to pitolisant for the
treatment of Prader-Willi syndrome (PWS); on track to initiate the
Phase 3 TEMPO study in patients with PWS in the first quarter of
2024
- Reported positive Phase 2 proof-of-concept (POC) data in EDS
and fatigue in Myotonic Dystrophy Type 1 (DM1) in the fourth
quarter of 2023
- On track to report pharmacokinetic (PK) data on next-gen
pitolisant-based formulations in the first half of 2024
- Expect 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
- On track to report pre-clinical POC data for HBS-102 in PWS in
the first half of 2024
- Repurchased approximately 3.2 million shares of common stock
for $100 million in full-year 2023 and expect to continue the
opportunistic repurchase of shares under the remaining share
repurchase program authorization of $150 million.
Fourth Quarter 2023 Financial Results
Net product revenue for the quarter ended December 31, 2023 was
$168.4 million, compared to $128.3 million for the same period in
2022. The 31% growth versus the same period in 2022 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 350 sequentially to approximately 6,150 for the
quarter ended December 31, 2023.
GAAP net income for the quarter ended December 31, 2023, was
$26.6 million, or $0.45 per diluted share, compared to GAAP net
income of $48.5 million, or $0.79 per diluted share, for the same
period in 2022. Non-GAAP adjusted net income was $42.8 million, or
$0.73 per diluted share, for the quarter ended December 31, 2023,
compared to Non-GAAP adjusted net income of $61.9 million, or $1.01
per diluted share, for the same period in 2022.
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 $30.3 million in the
fourth quarter of 2023, as compared to $10.1 million for the same
quarter in 2022, representing a 200% increase. Expenses in the
fourth quarter of 2023 included one-time Zynerba transaction
related costs of $6.0 million;
- Sales and Marketing expenses were $26.9 million in the fourth
quarter of 2023, as compared to $21.1 million for the same quarter
in 2022, representing a 28% increase;
- General and Administrative expenses were $27.9 million in the
fourth quarter of 2023, as compared to $22.6 million for the same
quarter in 2022, representing a 23% increase. Expenses in the
fourth quarter of 2023 included one-time Zynerba transaction
related costs of $3.8 million; and
- Total Operating Expenses were $85.1 million in the fourth
quarter of 2023, as compared to $53.8 million for the same quarter
in 2022, representing a 58% increase. Total Operating Expenses in
the fourth quarter of 2023 included one-time Zynerba transaction
related costs of $9.8 million.
Full Year 2023 Financial Results
Net product revenue for the year ended December 31, 2023 was
$582.0 million, compared to $437.9 million for 2022. The 33% growth
versus the same period in 2022 is primarily attributed to strong
commercial sales of WAKIX driven by continued organic demand
tapping into a large market opportunity.
GAAP net income for the year ended December 31, 2023, was $128.9
million, or $2.13 per diluted share, compared to GAAP net income of
$181.5 million, or $2.97 per diluted share, for 2022. The decrease
in GAAP net income was primarily driven by the release of the
valuation allowance on our deferred tax assets, which resulted in a
$74.5 million income tax benefit for the year ended December 31,
2022. Non-GAAP adjusted net income was $188.4 million, or $3.12 per
diluted share, for the year ended December 31, 2023, compared to
Non-GAAP adjusted net income of $183.5 million, or $3.00 per
diluted share, for 2022.
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 $76.1 million for the
year ended December 31, 2023, as compared to $70.9 million for the
prior year, representing a 7% increase. Expenses in 2023 included
one-time Zynerba transaction related costs of $6.0 million;
- Sales and Marketing expenses were $97.4 million for the year
ended December 31, 2023, as compared to $79.3 million for the prior
year, representing a 23% increase;
- General and Administrative expenses were $95.3 million for the
year ended December 31, 2023, as compared to $84.0 million for the
prior year, representing a 13% increase. Expenses in 2023 included
one-time Zynerba transaction related costs of $3.8 million;
and
- Total Operating Expenses were $268.8 million for the year ended
December 31, 2023, as compared to $234.2 million for the prior
year, representing a 15% increase. Total Operating Expenses in 2023
included one-time Zynerba transaction related costs of $9.8
million.
As of December 31, 2023, Harmony had cash, cash equivalents and
investment securities of $425.6 million, compared to $345.7 million
on December 31, 2022.
2024 Net Product Revenue Guidance
Expect full year 2024 net product revenue of $700 million to
$720 million.
Conference Call Today at 8:30 a.m. ET We are
hosting our fourth quarter and full year 2023 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 HRMYQ423.
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 Myotonic Dystrophy Type 1
Myotonic dystrophy Type 1 (DM1) is the most common form of
adult-onset muscular dystrophy. It is a genetic disorder inherited
in an autosomal-dominant pattern. Latest estimates suggest a
prevalence of about one per 2,100 people with the genetic defect
for DM1. This equates to about 150,000 people in the U.S. with the
genetic defect for DM1. Estimates suggest there are 40,000 people
currently diagnosed with DM1 in the U.S., with up to 90% of them
reporting EDS and fatigue and over 60% of them experiencing
cognitive dysfunction.
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 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 HBS-102HBS-102, an investigational
compound, is a melanin-concentrating hormone (MCH) receptor 1
(MCHR1) antagonist that targets MCH neurons in the brain. It has
the potential to be a first-in-class molecule with a novel
mechanism of action that could offer a new approach to the
treatment of a variety of rare neurological diseases.
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 StatementsThis 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 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 SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS) (In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net product revenue |
$ |
168,412 |
|
|
$ |
128,308 |
|
|
$ |
582,022 |
|
|
$ |
437,855 |
|
Cost of product sold |
|
43,152 |
|
|
|
26,885 |
|
|
|
121,236 |
|
|
|
83,481 |
|
Gross profit |
|
125,260 |
|
|
|
101,423 |
|
|
|
460,786 |
|
|
|
354,374 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
30,306 |
|
|
|
10,092 |
|
|
|
76,063 |
|
|
|
70,886 |
|
Sales and marketing |
|
26,886 |
|
|
|
21,075 |
|
|
|
97,404 |
|
|
|
79,285 |
|
General and administrative |
|
27,872 |
|
|
|
22,643 |
|
|
|
95,289 |
|
|
|
84,017 |
|
Total operating expenses |
|
85,064 |
|
|
|
53,810 |
|
|
|
268,756 |
|
|
|
234,188 |
|
Operating income |
|
40,196 |
|
|
|
47,613 |
|
|
|
192,030 |
|
|
|
120,186 |
|
Loss on debt
extinguishment |
|
— |
|
|
|
— |
|
|
|
(9,766 |
) |
|
|
— |
|
Other expense (income),
net |
|
193 |
|
|
|
73 |
|
|
|
159 |
|
|
|
169 |
|
Interest expense |
|
(4,796 |
) |
|
|
(5,444 |
) |
|
|
(23,757 |
) |
|
|
(18,795 |
) |
Interest income |
|
4,096 |
|
|
|
1,861 |
|
|
|
14,730 |
|
|
|
3,126 |
|
Income before income
taxes |
|
39,689 |
|
|
|
44,103 |
|
|
|
173,396 |
|
|
|
104,686 |
|
Income tax benefit
(expense) |
|
(13,082 |
) |
|
|
4,406 |
|
|
|
(44,543 |
) |
|
|
76,782 |
|
Net income |
$ |
26,607 |
|
|
$ |
48,509 |
|
|
$ |
128,853 |
|
|
$ |
181,468 |
|
EARNINGS PER SHARE: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.46 |
|
|
$ |
0.82 |
|
|
$ |
2.17 |
|
|
$ |
3.07 |
|
Diluted |
$ |
0.45 |
|
|
$ |
0.79 |
|
|
$ |
2.13 |
|
|
$ |
2.97 |
|
Weighted average number of shares of common stock - basic |
|
58,320,400 |
|
|
|
59,478,933 |
|
|
|
59,469,648 |
|
|
|
59,173,121 |
|
Weighted average number of shares of common stock - diluted |
|
58,853,292 |
|
|
|
61,620,712 |
|
|
|
60,372,397 |
|
|
|
61,097,045 |
|
HARMONY BIOSCIENCES HOLDINGS, INC. AND
SUBSIDIARYCONSOLIDATED BALANCE
SHEETS(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
ASSETS |
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
311,660 |
|
|
$ |
243,784 |
|
Investments, short-term |
|
41,800 |
|
|
|
79,331 |
|
Trade receivables, net |
|
74,140 |
|
|
|
54,740 |
|
Inventory, net |
|
5,363 |
|
|
|
4,297 |
|
Prepaid expenses |
|
12,570 |
|
|
|
9,347 |
|
Other current assets |
|
5,537 |
|
|
|
8,786 |
|
Total current assets |
|
451,070 |
|
|
|
400,285 |
|
NONCURRENT ASSETS: |
|
|
|
|
|
Property and equipment, net |
|
371 |
|
|
|
573 |
|
Restricted cash |
|
270 |
|
|
|
750 |
|
Investments, long-term |
|
72,169 |
|
|
|
22,568 |
|
Intangible assets, net |
|
137,108 |
|
|
|
160,953 |
|
Deferred tax asset |
|
144,162 |
|
|
|
85,943 |
|
Other noncurrent assets |
|
6,298 |
|
|
|
2,798 |
|
Total noncurrent assets |
|
360,378 |
|
|
|
273,585 |
|
TOTAL ASSETS |
$ |
811,448 |
|
|
$ |
673,870 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Trade payables |
$ |
17,730 |
|
|
$ |
3,786 |
|
Accrued compensation |
|
23,747 |
|
|
|
11,532 |
|
Accrued expenses |
|
99,494 |
|
|
|
59,942 |
|
Current portion of long-term debt |
|
15,000 |
|
|
|
2,000 |
|
Other current liabilities |
|
7,810 |
|
|
|
1,624 |
|
Total current liabilities |
|
163,781 |
|
|
|
78,884 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
Long-term debt, net |
|
178,566 |
|
|
|
189,647 |
|
Other noncurrent liabilities |
|
2,109 |
|
|
|
2,501 |
|
Total noncurrent liabilities |
|
180,675 |
|
|
|
192,148 |
|
TOTAL LIABILITIES |
|
344,456 |
|
|
|
271,032 |
|
COMMITMENTS AND CONTINGENCIES (Note 13) |
|
|
|
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
Common stock—$0.00001 par value; 500,000,000 shares authorized at
December 31, 2023 and December 31, 2022,
respectively; - shares 56,769,081 and 59,615,731 issued and
outstanding at December 31, 2023 and
December 31, 2022, respectively |
|
1 |
|
|
|
1 |
|
Additional paid in capital |
|
610,266 |
|
|
|
675,118 |
|
Accumulated other comprehensive (loss) income |
|
2 |
|
|
|
(151 |
) |
Accumulated deficit |
|
(143,277 |
) |
|
|
(272,130 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
466,992 |
|
|
|
402,838 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
811,448 |
|
|
$ |
673,870 |
|
HARMONY BIOSCIENCES HOLDINGS,
INC.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL
RESULTS(In thousands except share and per share
data) |
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP net
income |
$ |
26,607 |
|
|
$ |
48,509 |
|
|
$ |
128,853 |
|
|
$ |
181,468 |
|
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash interest expense (1) |
|
185 |
|
|
|
422 |
|
|
|
3,246 |
|
|
|
1,663 |
|
Depreciation |
|
164 |
|
|
|
107 |
|
|
|
514 |
|
|
|
419 |
|
Amortization (2) |
|
5,961 |
|
|
|
5,961 |
|
|
|
23,845 |
|
|
|
22,966 |
|
Stock-based compensation expense |
|
8,894 |
|
|
|
7,671 |
|
|
|
31,205 |
|
|
|
26,905 |
|
Transaction related costs (3) |
|
9,804 |
|
|
|
- |
|
|
|
9,804 |
|
|
|
- |
|
Loss on debt extinguishment |
|
- |
|
|
|
- |
|
|
|
9,766 |
|
|
|
- |
|
Licensing fees and milestone payments (4) |
|
- |
|
|
|
- |
|
|
|
750 |
|
|
|
30,000 |
|
Valuation allowance release |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(74,474 |
) |
Income tax effect related to non-GAAP adjustments (5) |
|
(8,789 |
) |
|
|
(731 |
) |
|
|
(19,624 |
) |
|
|
(5,409 |
) |
Non-GAAP adjusted net income |
$ |
42,826 |
|
|
$ |
61,939 |
|
|
$ |
188,359 |
|
|
$ |
183,538 |
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP reported net
income per diluted share |
$ |
0.45 |
|
|
$ |
0.79 |
|
|
$ |
2.13 |
|
|
$ |
2.97 |
|
Non-GAAP adjusted net income
per diluted share |
$ |
0.73 |
|
|
$ |
1.01 |
|
|
$ |
3.12 |
|
|
$ |
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock used in non-GAAP diluted per share |
|
58,853,292 |
|
|
|
61,620,712 |
|
|
|
60,372,397 |
|
|
|
61,097,045 |
|
(1) Includes amortization of deferred finance charges.(2)
Includes amortization of intangible asset related to WAKIX.(3)
Includes costs associated with the acquisition of Zynerba in
October 2023. There were $2.3M of IPR&D charges and $3.7M of
severance recorded in research and development expenses and $3.8M
of severance recorded in general and administrative expenses. (4)
Includes a $0.8M milestone payment related to HBS-102 preclinical
milestone in March 2023 and $30M licensing fee incurred upon
closing the 2022 Licensing and Commercialization Agreement with
Bioprojet in August 2022. (5) 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)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Harmony Biosciences (NASDAQ:HRMY)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024