Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”)
(Nasdaq: HRMY), a pharmaceutical company dedicated to developing
and commercializing innovative therapies for patients with rare
neurological diseases, today reported financial results and
business updates for the quarter ended September 30, 2023.
“We continue to demonstrate very strong growth in our commercial
business, with WAKIX in narcolepsy delivering the strongest revenue
quarter in Harmony's history,” stated Jeffrey M. Dayno, M.D.,
President and Chief Executive Officer of Harmony. “In addition, we
advanced our pitolisant pipeline programs, and expanded our
pipeline with the addition of Zygel through the closing of the
Zynerba acquisition.”
“Given our continued confidence in the underlying strength of
the business and our conviction in the growth potential for the
company, we are announcing a new share repurchase program of $200
million.”
Third Quarter 2023 Financial Results
Net product revenues for the quarter ended September 30, 2023
were $160.3 million, compared to $117.2 million for the same period
in 2022. The 37% 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
United States). The average number of patients on WAKIX increased
by approximately 350 sequentially to approximately 5,800 for the
quarter ended September 30, 2023.
GAAP net income for the quarter ended September 30, 2023 was
$38.5 million, or $0.63 earnings per diluted share, compared to
GAAP net income of $87.9 million, or $1.44 earnings per diluted
share, for the same period in 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 quarter ended September 30, 2022, partially
offset by a $30.0 million initial licensing fee as part of the 2022
Licensing and Commercialization Agreement with Bioprojet (the “2022
LCA”). For the quarter ended September 30, 2023, we also incurred a
$9.8 million loss on debt extinguishment. Non-GAAP adjusted net
income was $58.8 million, or $0.97 earnings per diluted share, for
the quarter ended September 30, 2023, compared to Non-GAAP adjusted
net income of $58.1 million, or $0.95 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 $17.5 million in the
third quarter of 2023, as compared to $40.5 million for the same
quarter in 2022, representing a 57% decrease, driven by a $30.0
million licensing fee as part of the 2022 LCA incurred during the
third quarter of 2022;
- Sales and Marketing expenses were $23.4 million in the third
quarter of 2023, as compared to $20.5 million for the same quarter
in 2022, representing a 14% increase;
- General and Administrative expenses were $22.5 million in the
third quarter of 2023, as compared to $21.3 million for the same
quarter in 2022, representing a 6% increase; and
- Total Operating Expenses were $63.5 million in the third
quarter of 2023, as compared to $82.3 million for the same quarter
in 2022, representing a 23% decrease.
As of September 30, 2023, Harmony had cash, cash equivalents and
investment securities of $438.4 million, compared to $345.7 million
as of December 31, 2022.
Company Updates
- Reported topline results from the Phase 3 INTUNE study in adult
patients with idiopathic hypersomnia (IH). While the primary
endpoint did not reach statistical significance during the
randomized withdrawal phase, a robust clinical effect was
demonstrated in the open label phase of the study. Based on the
totality of the data, the company remains committed and continues
to pursue an indication for pitolisant in IH. Next step is to meet
with the FDA informed by the review of the full data
set.
- Received FDA alignment on the protocol for the Phase 3 TEMPO
study in patients with Prader-Willi syndrome (PWS) which will
satisfy the requirements for both the registrational trial and now
pediatric exclusivity as well. We expect to initiate the study in
the first quarter of 2024.
- On track for topline data from the Myotonic Dystrophy (DM1)
Phase 2 proof-of-concept signal detection trial in the fourth
quarter of 2023.
- On track to submit a supplemental new drug application (sNDA)
for a pediatric narcolepsy indication to the FDA in the fourth
quarter of 2023.
- Advancing new pitolisant based formulations into the clinic in
the fourth quarter of 2023. Anticipate data in the first half of
2024.
- Expanded and diversified our pipeline with the acquisition of
Zynerba Pharmaceuticals. Zygel is in a Pivotal Phase 3 trial for
Fragile X syndrome (FXS).
- During the third quarter of 2023, the company repurchased
1,439,792 shares of common stock at an aggregate cost of $50
million, as part of the prior $125 million share repurchase
program, which we closed.
- Our Board of Directors authorized a new $200 million share
repurchase program.
Conference Call Today at 8:30 a.m. ET We are
hosting our third quarter 2023 financial results conference call
and webcast today, beginning 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) 245-3047 (domestic) or +1 (203) 518-9765
(international), and reference passcode HRMYQ323.
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 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 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 165,000 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 Zygel™
Zygel is the first and only pharmaceutically manufactured,
synthetic cannabidiol, non-euphoric cannabinoid, formulated as a
patent-protected permeation-enhanced gel for transdermal delivery
through the skin and into the circulatory system. Zygel is
manufactured through a synthetic process in a cGMP facility and is
not extracted from the cannabis plant. Therefore, it is devoid of
THC, which is what causes the euphoric effect of cannabis, and has
the potential to be a nonscheduled product if approved.
Cannabidiol, the active ingredient in Zygel, has been granted
orphan drug designation by the FDA and the EMA for the treatment of
FXS and for the treatment of 22q11.2 deletion syndrome (22q).
Additionally, Zygel 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, affecting 1 in 3,600 to 4,000 males and 1 in 4,000 to
6,000 females. 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. There are approximately 80,000 people
in the U.S. and approximately 121,000 people in the European Union
and UK living with FXS. 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 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 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 HOLDINGS, INC. AND
SUBSIDIARY CONSOLIDATEDSTATEMENTS
OF OPERATIONS AND COMPREHENSIVE INCOME (In
thousands, except share and per share data) |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Net product revenues |
|
$ |
160,268 |
|
$ |
117,206 |
|
$ |
413,610 |
|
$ |
309,547 |
Cost of product sold |
|
|
32,296 |
|
|
22,959 |
|
|
78,084 |
|
|
56,596 |
Gross profit |
|
|
127,972 |
|
|
94,247 |
|
|
335,526 |
|
|
252,951 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
17,499 |
|
|
40,548 |
|
|
45,757 |
|
|
60,794 |
Sales and marketing |
|
|
23,418 |
|
|
20,467 |
|
|
70,518 |
|
|
58,210 |
General and administrative |
|
|
22,546 |
|
|
21,331 |
|
|
67,417 |
|
|
61,374 |
Total operating expenses |
|
|
63,463 |
|
|
82,346 |
|
|
183,692 |
|
|
180,378 |
Operating income |
|
|
64,509 |
|
|
11,901 |
|
|
151,834 |
|
|
72,573 |
Loss on debt
extinguishment |
|
|
(9,766) |
|
|
— |
|
|
(9,766) |
|
|
— |
Other (expense) income,
net |
|
|
(5) |
|
|
56 |
|
|
(34) |
|
|
96 |
Interest expense, net |
|
|
(2,906) |
|
|
(3,990) |
|
|
(8,327) |
|
|
(12,086) |
Income before income
taxes |
|
|
51,832 |
|
|
7,967 |
|
|
133,707 |
|
|
60,583 |
Income tax (expense)
benefit |
|
|
(13,371) |
|
|
79,976 |
|
|
(31,461) |
|
|
72,376 |
Net income |
|
$ |
38,461 |
|
$ |
87,943 |
|
$ |
102,246 |
|
$ |
132,959 |
Unrealized income (loss) on
investments |
|
|
6 |
|
|
(149) |
|
|
(365) |
|
|
(178) |
Comprehensive income |
|
$ |
38,467 |
|
$ |
87,794 |
|
$ |
101,881 |
|
$ |
132,781 |
EARNINGS PER SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.64 |
|
$ |
1.48 |
|
$ |
1.71 |
|
$ |
2.25 |
Diluted |
|
$ |
0.63 |
|
$ |
1.44 |
|
$ |
1.68 |
|
$ |
2.18 |
Weighted average number of shares of common stock - basic |
|
|
59,863,102 |
|
|
59,234,720 |
|
|
59,856,941 |
|
|
59,070,063 |
Weighted average number of shares of common stock - diluted |
|
|
60,681,676 |
|
|
61,207,625 |
|
|
60,892,992 |
|
|
60,921,482 |
HARMONY BIOSCIENCES HOLDINGS,
INC.CONSOLIDATED BALANCE
SHEETS(In thousands except share and per share
data) |
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
324,603 |
|
|
$ |
243,784 |
|
Investments, short-term |
|
|
46,071 |
|
|
|
79,331 |
|
Trade receivables, net |
|
|
67,264 |
|
|
|
54,740 |
|
Inventory, net |
|
|
5,087 |
|
|
|
4,297 |
|
Prepaid expenses |
|
|
14,269 |
|
|
|
9,347 |
|
Other current assets |
|
|
5,704 |
|
|
|
8,786 |
|
Total current assets |
|
|
462,998 |
|
|
|
400,285 |
|
NONCURRENT ASSETS: |
|
|
|
|
|
|
Property and equipment, net |
|
|
428 |
|
|
|
573 |
|
Restricted cash |
|
|
250 |
|
|
|
750 |
|
Investments, long-term |
|
|
67,700 |
|
|
|
22,568 |
|
Intangible assets, net |
|
|
143,069 |
|
|
|
160,953 |
|
Deferred tax asset |
|
|
100,485 |
|
|
|
85,943 |
|
Other noncurrent assets |
|
|
2,836 |
|
|
|
2,798 |
|
Total noncurrent assets |
|
|
314,768 |
|
|
|
273,585 |
|
TOTAL ASSETS |
|
$ |
777,766 |
|
|
$ |
673,870 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Trade payables |
|
$ |
6,539 |
|
|
$ |
3,786 |
|
Accrued compensation |
|
|
10,322 |
|
|
|
11,532 |
|
Accrued expenses |
|
|
72,761 |
|
|
|
59,942 |
|
Current portion of long-term debt |
|
|
15,000 |
|
|
|
2,000 |
|
Other current liabilities |
|
|
7,786 |
|
|
|
1,624 |
|
Total current liabilities |
|
|
112,408 |
|
|
|
78,884 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
|
Long-term debt, net |
|
|
182,131 |
|
|
|
189,647 |
|
Other noncurrent liabilities |
|
|
1,895 |
|
|
|
2,501 |
|
Total noncurrent liabilities |
|
|
184,026 |
|
|
|
192,148 |
|
TOTAL LIABILITIES |
|
|
296,434 |
|
|
|
271,032 |
|
COMMITMENTS AND CONTINGENCIES (Note 12) |
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
Common stock—$0.00001 par value; 500,000,000 shares authorized at
September 30, 2023 and December 31, 2022,
respectively; 58,571,944 shares and 59,615,731 issued and
outstanding at September 30, 2023 and
December 31, 2022, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid in capital |
|
|
651,731 |
|
|
|
675,118 |
|
Accumulated other comprehensive (loss) income |
|
|
(516 |
) |
|
|
(151 |
) |
Accumulated deficit |
|
|
(169,884 |
) |
|
|
(272,130 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
|
481,332 |
|
|
|
402,838 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
777,766 |
|
|
$ |
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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
September 30, |
|
September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
GAAP net income |
|
$ |
38,461 |
|
|
$ |
87,943 |
|
|
$ |
102,246 |
|
|
$ |
132,959 |
|
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash interest expense (1) |
|
|
2,221 |
|
|
|
418 |
|
|
|
3,061 |
|
|
|
1,241 |
|
Depreciation |
|
|
144 |
|
|
|
101 |
|
|
|
350 |
|
|
|
312 |
|
Amortization (2) |
|
|
5,962 |
|
|
|
5,962 |
|
|
|
17,884 |
|
|
|
17,005 |
|
Stock-based compensation expense |
|
|
7,957 |
|
|
|
6,967 |
|
|
|
22,311 |
|
|
|
19,234 |
|
Licensing fee (3) |
|
|
- |
|
|
|
30,000 |
|
|
|
- |
|
|
|
30,000 |
|
Loss on debt extinguishment |
|
|
9,766 |
|
|
|
- |
|
|
|
9,766 |
|
|
|
- |
|
Valuation allowance release |
|
|
- |
|
|
|
(74,474 |
) |
|
|
- |
|
|
|
(74,474 |
) |
Income tax effect related to non-GAAP adjustments (4) |
|
|
(5,723 |
) |
|
|
1,175 |
|
|
|
(10,835 |
) |
|
|
(2,341 |
) |
Non-GAAP adjusted net income |
|
$ |
58,788 |
|
|
$ |
58,092 |
|
|
$ |
144,783 |
|
|
$ |
123,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP reported net
income per diluted share |
|
$ |
0.63 |
|
|
$ |
1.44 |
|
|
$ |
1.68 |
|
|
$ |
2.18 |
|
Non-GAAP adjusted net income
per diluted share |
|
$ |
0.97 |
|
|
$ |
0.95 |
|
|
$ |
2.38 |
|
|
$ |
2.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock used in non-GAAP diluted per share |
|
|
60,681,676 |
|
|
|
61,207,625 |
|
|
|
60,892,992 |
|
|
|
60,921,482 |
|
(1) Includes amortization of deferred finance charges(2)
Includes amortization of intangible asset related to WAKIX (3)
Amount represents upfront licensing fee incurred upon closing the
2022 Licensing and Commercialization Agreement with Bioprojet.(4)
Calculated using the reported effective tax rate for the periods
presented less impact of discrete items
Harmony Biosciences Investor Contact:Luis
Sanay, CFA445-235-8386lsanay@harmonybiosciences.com
Harmony Biosciences Media Contact:Cate
McCanless202-641-6086cmccanless@harmonybiosciences.com
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