UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02. Results of Operations and Financial Condition.
On October 31, 2023, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2023. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On October 31, 2023, the Company posted an investor presentation to its website at https://ir.harmonybiosciences.com (the “Investor Presentation”). A copy of the Investor Presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Company expects to use the Investor Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others.
The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Investor Presentation speaks only as of the date of this Current Report on Form 8-K. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Investor Presentation, although it may do so from time to time. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. In addition, the exhibit furnished herewith contains statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in such exhibit. By furnishing the information contained in the Investor Presentation, the Company makes no admission as to the materiality of any information in the Investor Presentation that is required to be disclosed solely by reason of Regulation FD.
This Current Report on Form 8-K and its contents (including Exhibits 99.1 and 99.2) are furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 8.01. Other items.
On October 27, 2023, the Company’s Board of Directors approved a repurchase program providing for the repurchase of shares of common stock in the Company at an aggregate amount of up to $200.0 million, exclusive of commissions and transaction fees. The Board of Directors simultaneously terminated its prior repurchase program, which was previously approved on August 1, 2023, and provided for the repurchase of shares of common stock in the Company at an aggregate amount of up to $125.0 million.
The repurchase program has no expiration date and will continue until otherwise suspended, terminated or modified at any time for any reason by the Board of Directors. The share repurchase program does not obligate the Company to repurchase shares of common stock and the timing and actual number of shares repurchased will depend on a variety of factors including price, market conditions, corporate and regulatory requirements, and other investment opportunities. Information regarding share repurchases will be available in the Company’s periodic reports on Form 10-Q and Form 10-K filed with the SEC as required by the applicable rules of the Exchange Act.
Note Regarding Forward-Looking Statements
Certain statements in this Current Report on Form 8-K constitute “forward-looking statements” within the meaning of the federal securities laws. These statements are based on management’s current opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results. These forward looking statements are only predictions, not historical fact, and involve certain risks and uncertainties, as well as assumptions. Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward-looking statements. While the Company believes that its assumptions are reasonable, it is very difficult to predict the impact of known factors, and, of course, it is impossible to anticipate all factors that could affect actual results. There are many risks and uncertainties that could cause actual results to differ materially from forward-looking statements made herein including the risks discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC, as well as other factors described from time to time in the Company’s filings with the SEC. Such forward-looking statements are made only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update or revise any forward-looking statement because of new information, future events or otherwise, except as otherwise required by law. If it does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
| |
No. | Description | |
99.1* | ||
99.2* | ||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* | This Exhibit is furnished herewith and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
HARMONY BIOSCIENCES HOLDINGS, INC. | ||
Date: October 31, 2023 | By: | /s/ Sandip Kapadia |
Sandip Kapadia | ||
Chief Financial Officer and Chief Administrative Officer | ||
HARMONY BIOSCIENCES REPORTS STRONG THIRD QUARTER 2023 FINANCIAL RESULTS
Continued Strong Growth with WAKIX® (pitolisant) Net Revenue of $160.3 Million for Third Quarter 2023; Increased ~37% Year-over-Year
Average Number of Patients on WAKIX Increased by ~350 Sequentially to ~5,800 for Third Quarter 2023
Remain Committed and Continue to Pursue Idiopathic Hypersomnia Indication; Next Step to Meet with FDA Informed by Review of Full Data Set
Expanded and Diversified Pipeline with Acquisition of Zynerba Pharmaceuticals; Zygel™ in Pivotal Phase 3 Trial for Fragile X syndrome
Repurchased ~1.4 Million Shares of Common Stock for $50 Million in Third Quarter 2023; Board of Directors Authorized New $200 Million Share Repurchase Program
Conference Call and Webcast to be Held Today at 8:30 a.m. ET
PLYMOUTH MEETING, PA., October 31, 2023 — 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 Measures
In 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) 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 Narcolepsy
Narcolepsy 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 Hypersomnia
Idiopathic 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 Syndrome
PWS 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 Syndrome
Fragile 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 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 HOLDINGS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS 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 itemsHarmony Biosciences Investor Contact:
Luis Sanay, CFA
445-235-8386
lsanay@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
| Q3 2023 Financial and Business Update October 31, 2023 Exhibit 99.2 |
| Forward-Looking Statements 2 This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.’s (the “Company”) future financial position, business strategy and plans and objectives of management for future operations, should be considered forward-looking statements. Forward-looking statements use words like “believes,” “plans,” “expects,” “intends,” “will,” “would,” “anticipates,” “estimates,” and similar words or expressions in discussions of the Company’s future operations, financial performance or the Company’s strategies. These statements are based on current expectations or objectives that are inherently uncertain, especially in light of the Company’s limited operating history. These and other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 21, 2023 and its other filings with the SEC could cause actual results to differ materially and adversely from those indicated by the forward-looking statements made in this presentation. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management’s understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accuracy and completeness of such information cannot be assured. Neither the Company, nor any of its respective officers, directors, managers, employees, agents, or representatives, (i) make any representations or warranties, express or implied, with respect to any of the information contained herein, including the accuracy or completeness of this presentation or any other written or oral information made available to any interested party or its advisor (and any liability therefore is expressly disclaimed), (ii) have any liability from the use of the information, including with respect to any forward-looking statements, or (iii) undertake to update any of the information contained herein or provide additional information as a result of new information or future events or developments. |
| Continued Strong Growth For WAKIX® in Adult Narcolepsy Advancing the Pipeline Strong Financial Position to Maximize Shareholder Value Strongest Revenue Quarter in Harmony's History; Advancement and Expansion of the Pipeline 3 ▪ Q3 23: WAKIX Net Revenue of $160.3M +37% Year-over-Year Growth ▪ Q3 23: ~5,800 average number of patients on WAKIX ▪ Continued strong growth in average number of patients & WAKIX prescriber base ▪ Reported topline results from Phase 3 INTUNE study; remain committed to IH patient community and actively pursuing IH indication; next step is to meet with the FDA informed by review of the full data set ▪ Received FDA feedback on study protocol for Phase 3 TEMPO study in patients with PWS; expect to initiate the study in Q1 24 ▪ On track for topline data from DM1 Phase 2 POC study in Q4 23 ▪ On track for submission of sNDA for pediatric narcolepsy indication in Q4 23 ▪ Advancing new pitolisant based formulations into the clinic in Q4 23 ▪ Expanded and diversified the pipeline with acquisition of Zynerba Pharmaceuticals; Zygel in Phase 3 pivotal trial for Fragile X syndrome ▪ Profitable, cash generating with $438.4M on the balance sheet ▪ Share repurchase program: Repurchased ~1.4M shares of common stock at an aggregate cost of $50M during Q3 23. Board of Directors authorized new $200M share repurchase program. ▪ Well positioned to execute on business development to build out robust pipeline |
| WAKIX® Net Revenue Performance $117.2 Q3 22 Q3 23 4 WAKIX QUARTERLY NET REVENUE ($M) CONFIDENT IN WAKIX BECOMING A $1B+ OPPORTUNITY IN ADULT NARCOLEPSY ALONE WITH THE POTENTIAL TO CONTRIBUTE UP TO AN ADDITIONAL $1B, IF APPROVED IN OTHER CURRENT PITOLISANT LIFECYCLE MANAGEMENT PROGRAMS 37% Q3 23 HIGHLIGHTS ▪ Q3 23 Net Revenue of $160.3M; strongest revenue quarter in Harmony's history ▪ Underlying demand drove continued double-digit revenue growth of 37% vs. Q3 22 ▪ Strong patient interest ▪ Continue to add new prescribers and grow WAKIX prescriber base $160.3 |
| 5 +300 +300 +400 +300 +300 +100 +400 +300 +300 +200 +350 2,200 ~5,800 0 1,000 2,000 3,000 4,000 5,000 6,000 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 Average # of Patients Net Patient Additions Continued Strong Growth In Average Number of Patients on WAKIX® ~Average # of Patients on WAKIX 1. Net Patient Additions based on previously disclosed quarterly average number of patients on WAKIX. ~Approximate Patient Counts 1 Q3 23 HIGHLIGHTS ▪ Average Number of Patients on WAKIX increased to ~5,800 ▪ +350 from reported in Q2 23 ▪ Continued growth in depth and breadth of prescriber base beyond HCPs enrolled in oxybate REMS program ▪ Strong payer coverage to support continued growth ~5,800 Average Number of Patients on WAKIX in Q3 23 +350 |
| Prescriber Dynamics Support Continued WAKIX® Growth in Adult Narcolepsy ~9,000 Narcolepsy Treating HCPs HCPs enrolled in oxybate REMS HCPs not enrolled in oxybates REMS WAKIX growth Depth of prescribing in oxybate REMS enrolled HCPs Breadth of prescribing in HCPs not enrolled in oxybate REMS ~4,000 ~5,000 Harmony Field Sales Team covers narcolepsy treating HCP universe Access to ~100% of diagnosed adult patient opportunity 100% of HCPs surveyed with WAKIX experience stated they would write the same/increase Rx in next 6 months.¹ >40% of HCPs surveyed who had not prescribed WAKIX to date indicated intent to Rx in next 6 months.¹ Unique feature as non-scheduled treatment is the highest performing driver and differentiator for WAKIX.¹ 1. Harmony Market Research, October 2023 6 |
| Product / Indication Pre-IND Phase 1 Phase 2 Phase 3 Regulatory Filing Marketed Product Milestone Pitolisant Topline data 4Q2023 1. Trial conducted by Bioprojet and Bioprojet submitted regulatory package to EMA. Bioprojet received EMA approval on March 15, 2023. Prader-Willi Syndrome (PWS) Myotonic Dystrophy (DM) HBS-102 EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (Adults) PWS WAKIX® Idiopathic Hypersomnia (IH) Full Dataset Review Ongoing Pediatric Narcolepsy1 Submit sNDA 4Q2023 Preclinical POC study initiated 3Q2022 Development Pipeline New Pitolisant Assets 7 Initiate Studies 4Q2023 Initiate Ph3 1Q2024 Fragile X Syndrome (FXS) Zygel™ 22q11.2 Deletion Syndrome (22q) |
| Extending the Pitolisant Franchise ▪ Opportunity: Extend franchise beyond 2040, with potential for new IP and opportunity to explore additional indications ▪ Formulation: Enhanced formulation designed to deliver an optimized PK profile and a higher dosage strength ▪ Program: Full development program ▪ Status: First-in-Human study commenced in Q4 2023 Formulation 1 ▪ Opportunity: Fast to market strategy for narcolepsy within WAKIX lifecycle ▪ Formulation: Modified formulation with potential clinical differentiation ▪ Program: Abbreviated development program ▪ Status: Phase 1 PK study expected to start in Q4 2023 Formulation 2 Anticipate Data in First Half of 2024 8 |
| $316.0 $345.7 $392.4 $429.6 $438.4 Sep 30 '22 Dec 31 '22 Mar 31 '23 Jun 30 '23 Sep 30 '23 Financial Highlights (1) Non-GAAP Adjusted Net Income= GAAP Net Income excluding non-cash interest expense, depreciation, amortization, stock-based compensation, other non-operating items and tax effect of these items. (In millions, USD) 9 Cash, Cash Equivalents & Investment Securities Non-GAAP Adjusted Net Income(1) $117.2 $160.3 Q3 2022 Q3 2023 $58.1 $58.8 Q3 2022 Q3 2023 37% Net Product Revenues 1% |
| (In millions, USD) Three Months Ended September 30, % Change 2023 2022 Net Product Revenues $160.3 $117.2 37% Cost of Product Sold 32.3 23.0 41% Total Operating Expenses $63.5 $82.3 (23%) R&D Expense 17.5 40.5 (57%) S&M Expense 23.4 20.5 14% G&A Expense 22.5 21.3 6% Net Income (1) $38.5 $87.9 (46%) Cash, cash equivalents & investment securities $438.4 Financial Summary Totals may not foot due to rounding 10 (1) Net income in Q3 2022 included a $74.5 million tax benefit related to a valuation allowance release, partially offset by a $30.0 million licensing fee incurred as R&D expense |
| (In millions, USD) Three Months Ended September 30, 2023 2022 GAAP net income $38.5 $87.9 Non-cash interest expense(1) 2.2 0.4 Depreciation 0.1 0.1 Amortization(2) 6.0 6.0 Stock-based compensation expense 7.9 7.0 Licensing fee(3) - 30.0 Loss on debt extinguishment 9.8 - Valuation allowance release - (74.5) Income tax effect related to Non-GAAP adjustments(4) (5.7) 1.2 Non-GAAP adjusted net income $58.8 $58.1 GAAP reported net income per diluted share $0.63 $1.44 Non-GAAP adjusted net income per diluted share $0.97 $0.95 Weighted average number of shares of common stock used in non-GAAP diluted per share 60,681,676 61,207,625 GAAP vs NON-GAAP Reconciliation (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 Totals may not foot due to rounding 11 |
| $1B+ Commercial Opportunity for WAKIX® in Adult Narcolepsy Expanding and Diversifying the Pipeline; Advancing New Pitolisant Assets Strong Financial Position ($438M) to Maximize Shareholder Value Executing on Our Growth Strategy Up to $1B Opportunity in Pitolisant LCM Programs (IH, PWS, DM1) 12 |
| Thank You |
