UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On August 1, 2023, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 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 August 1, 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 August 1, 2023, the Company’s Board of Directors approved a repurchase program providing for the repurchase of shares of common stock in an aggregate amount of up to $125.0 million, exclusive of commissions and transaction fees.
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, 2021 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: August 1, 2023 | By: | /s/ Sandip Kapadia |
Sandip Kapadia | ||
Chief Financial Officer | ||
HARMONY BIOSCIENCES REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATES
WAKIX® (pitolisant) Net Revenue Increased ~25% Year-over-Year to $134.2 Million for Second Quarter 2023
Average Number of Patients on WAKIX Increased by ~350 Sequentially to ~5,450 for Second Quarter 2023
Exited Second Quarter 2023 With ~5,600 Patients on WAKIX
Completed Enrollment in Phase 3 Idiopathic Hypersomnia (IH) INTUNE Study; On-track for Topline Data in Fourth Quarter 2023
Plans to Initiate Prader-Willi Syndrome (PWS) Phase 3 Study in
Fourth Quarter 2023
Board of Directors Authorized $125 Million Share Repurchase Program
Conference Call and Webcast to be Held Today at 8:30 a.m. ET
PLYMOUTH MEETING, Pa., August 1, 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 June 30, 2023.
“This quarter represented the highest top line prescription demand since our first full quarter of launch in 2020 and the strongest quarter of new patient starts in our history,” said Jeffrey M. Dayno, M.D. President and Chief Executive Officer at Harmony. “This sustained momentum in our core business, driven by robust underlying demand, reinforces our confidence in WAKIX being a $1 billion plus opportunity in narcolepsy alone.”
“Our share repurchase program reflects our ongoing confidence in the strength of our core business as well as our conviction in the long-term growth potential for Harmony. Looking ahead, we made significant progress in all of our current life cycle management programs setting us up for a catalyst rich remainder of the year.”
Second Quarter 2023 Financial Results
Net product revenues for the quarter ended June 30, 2023 were $134.2 million, compared to $107.0 million for the same period in 2022. The 25% 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), partially offset by specialty pharmacy buying patterns resulting in lower trade inventory levels at the end of the quarter. The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 5,450 patients for the quarter ended June 30, 2023. We exited the quarter ended June 30, 2023, with approximately 5,600 patients on WAKIX.
GAAP net income for the quarter ended June 30, 2023, was $34.3 million, or $0.56 earnings per diluted share, compared to GAAP net income of $23.5 million, or $0.39 earnings per diluted share, for the same period in 2022. Non-GAAP adjusted net income was $45.9 million, or $0.76 earnings per diluted share, for the quarter ended June 30, 2023, compared to Non-GAAP adjusted net income of $34.7 million, or $0.57 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 $15.0 million in the second quarter of 2023, as compared to $12.7 million for the same quarter in 2022, representing a 18% increase; |
| ● | Sales and Marketing expenses were $24.5 million in the second quarter of 2023, as compared to $20.2 million for the same quarter in 2022, representing a 22% increase; |
| ● | General and Administrative expenses were $22.8 million in the second quarter of 2023, as compared to $22.2 million for the same quarter in 2022, representing a 3% increase; and |
| ● | Total Operating Expenses were $62.3 million in the second quarter of 2023, as compared to $55.0 million for the same quarter in 2022, representing a 13% increase. |
As of June 30, 2023, Harmony had cash, cash equivalents and investment securities of $429.6 million, compared to $345.7 million as of December 31, 2022.
Company Updates
| ● | Completed enrollment of Phase 3 registrational trial (INTUNE Study) in adult patients with IH, nine months ahead of plan, and on-track for topline data in the fourth quarter of 2023. |
| ● | Positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”). We plan to initiate a Phase 3 study in patients with PWS in the fourth quarter of 2023. |
| ● | On-track for topline data from the Myotonic Dystrophy (“DM1”) Phase 2 proof-of-concept signal detection trial in the fourth quarter of 2023. |
| ● | Regarding a pediatric narcolepsy indication, we are working with Bioprojet on the submission to FDA of a supplemental new drug application (“sNDA”) for pediatric narcolepsy. We expect to submit the sNDA in the fourth quarter of 2023. |
| ● | We are actively pursuing pediatric exclusivity for WAKIX and have made progress with FDA in aligning on the requirements. |
| ● | Our Board of Directors authorized a $125 million share repurchase program. |
| ● | We entered into a new $185 million term loan facility, further strengthening the balance sheet and reducing annual interest expense by approximately $6 million. Net proceeds from the new term loan facility and cash on hand were used to repay existing debt. |
Conference Call Today at 8:30 a.m. ET
We are hosting our second quarter 2023 financial results conference call and webcast today at 8:30 a.m. Eastern Time. The live and replayed 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 HRMYQ223.
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 HBS-102
HBS-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 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. 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 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 June 30, | | Six Months Ended June 30, | ||||||||
|
| 2023 |
| 2022 |
| 2023 |
| 2022 | ||||
Net product revenues | | $ | 134,216 | | $ | 107,028 | | $ | 253,342 | | $ | 192,341 |
Cost of product sold | |
| 25,008 | |
| 18,921 | |
| 45,788 | |
| 33,637 |
Gross profit | |
| 109,208 | |
| 88,107 | |
| 207,554 | |
| 158,704 |
Operating expenses: | |
|
| |
|
| |
|
| |
|
|
Research and development | |
| 14,969 | |
| 12,668 | |
| 28,258 | |
| 20,246 |
Sales and marketing | |
| 24,528 | |
| 20,160 | |
| 47,100 | |
| 37,743 |
General and administrative | |
| 22,809 | |
| 22,163 | |
| 44,871 | |
| 40,043 |
Total operating expenses | |
| 62,306 | |
| 54,991 | |
| 120,229 | |
| 98,032 |
Operating income | |
| 46,902 | |
| 33,116 | |
| 87,325 | |
| 60,672 |
Other (expense) income, net | |
| (31) | |
| 42 | |
| (29) | |
| 40 |
Interest expense, net | |
| (2,776) | |
| (3,927) | |
| (5,421) | |
| (8,096) |
Income before income taxes | |
| 44,095 | |
| 29,231 | |
| 81,875 | |
| 52,616 |
Income tax expense | |
| (9,795) | |
| (5,700) | |
| (18,090) | |
| (7,600) |
Net income | | $ | 34,300 | | $ | 23,531 | | $ | 63,785 | | $ | 45,016 |
Unrealized loss on investments | |
| (491) | |
| (29) | |
| (371) | |
| (29) |
Comprehensive income | | $ | 33,809 | | $ | 23,502 | | $ | 63,414 | | $ | 44,987 |
EARNINGS PER SHARE: | |
|
| |
|
| |
|
| |
|
|
Basic | | $ | 0.57 | | $ | 0.40 | | $ | 1.07 | | $ | 0.76 |
Diluted | | $ | 0.56 | | $ | 0.39 | | $ | 1.05 | | $ | 0.74 |
Weighted average number of shares of common stock - basic | |
| 59,974,123 | |
| 59,063,358 | |
| 59,853,808 | |
| 58,986,370 |
Weighted average number of shares of common stock - diluted | |
| 60,743,953 | |
| 60,922,672 | |
| 60,997,410 | |
| 60,759,026 |
| | | | | | | | | | | | |
HARMONY BIOSCIENCES HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands except share and per share data)
|
| June 30, |
| December 31, | ||
|
| 2023 |
| 2022 | ||
ASSETS |
| |
|
| |
|
CURRENT ASSETS: |
| |
|
| |
|
Cash and cash equivalents | | $ | 317,415 | | $ | 243,784 |
Investments, short-term | | | 53,568 | | | 79,331 |
Trade receivables, net | |
| 63,812 | |
| 54,740 |
Inventory, net | |
| 4,854 | |
| 4,297 |
Prepaid expenses | |
| 9,442 | |
| 9,347 |
Other current assets | |
| 6,550 | |
| 8,786 |
Total current assets | |
| 455,641 | |
| 400,285 |
NONCURRENT ASSETS: | |
|
| |
|
|
Property and equipment, net | |
| 572 | |
| 573 |
Restricted cash | |
| 250 | |
| 750 |
Investments, long-term | | | 58,651 | | | 22,568 |
Intangible assets, net | |
| 149,031 | |
| 160,953 |
Deferred tax asset | | | 93,578 | | | 85,943 |
Other noncurrent assets | |
| 2,460 | |
| 2,798 |
Total noncurrent assets | |
| 304,542 | |
| 273,585 |
TOTAL ASSETS | | $ | 760,183 | | $ | 673,870 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
|
| |
|
|
CURRENT LIABILITIES: | |
|
| |
|
|
Trade payables | | $ | 6,563 | | $ | 3,786 |
Accrued compensation | |
| 7,972 | |
| 11,532 |
Accrued expenses | |
| 63,563 | |
| 59,942 |
Current portion of long-term debt | | | 11,000 | | | 2,000 |
Other current liabilities | |
| 3,947 | |
| 1,624 |
Total current liabilities | |
| 93,045 | |
| 78,884 |
NONCURRENT LIABILITIES: | |
|
| |
|
|
Long-term debt, net | |
| 180,487 | |
| 189,647 |
Other noncurrent liabilities | |
| 1,479 | |
| 2,501 |
Total noncurrent liabilities | |
| 181,966 | |
| 192,148 |
TOTAL LIABILITIES | |
| 275,011 | |
| 271,032 |
COMMITMENTS AND CONTINGENCIES (Note 12) | |
|
| |
|
|
STOCKHOLDERS’ EQUITY: | |
|
| |
|
|
Common stock—$0.00001 par value; 500,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 59,999,658 shares and 59,615,731 issued and outstanding at June 30, 2023 and December 31, 2022, respectively | |
| 1 | |
| 1 |
Additional paid in capital | |
| 694,038 | |
| 675,118 |
Accumulated other comprehensive (loss) income | | | (522) | | | (151) |
Accumulated deficit | |
| (208,345) | |
| (272,130) |
TOTAL STOCKHOLDERS’ EQUITY | |
| 485,172 | |
| 402,838 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 760,183 | | $ | 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 June 30, | | Six Months Ended June 30, | ||||||||
| | 2023 |
| 2022 |
| 2023 |
| 2022 | ||||
GAAP net income | | $ | 34,300 | | $ | 23,531 | | $ | 63,785 | | $ | 45,016 |
Non-GAAP Adjustments: | |
|
| |
|
| |
|
| |
|
|
Non-cash interest expense (1) | |
| 424 | |
| 411 | |
| 840 | |
| 823 |
Depreciation | |
| 103 | |
| 94 | |
| 206 | |
| 211 |
Amortization (2) | |
| 5,961 | |
| 5,961 | |
| 11,922 | |
| 11,043 |
Stock-based compensation expense | |
| 7,793 | |
| 7,371 | |
| 14,354 | |
| 12,267 |
Income tax effect related to non-GAAP adjustments (3) | |
| (2,712) | |
| (2,662) | |
| (5,112) | |
| (3,516) |
Non-GAAP adjusted net income | | $ | 45,869 | | $ | 34,706 | | $ | 85,995 | | $ | 65,844 |
| | | | | | | | | | | | |
GAAP reported net income per diluted share | | $ | 0.56 | | $ | 0.39 | | | 1.05 | | $ | 0.74 |
Non-GAAP adjusted net income per diluted share | | $ | 0.76 | | $ | 0.57 | | | 1.41 | | $ | 1.08 |
| | | | | | | | | | | | |
Weighted average number of shares of common stock used in non-GAAP diluted per share | |
| 60,743,953 | |
| 60,922,672 | |
| 60,997,410 | |
| 60,759,026 |
(1) Includes amortization of deferred finance charges
(2) Includes amortization of intangible asset related to WAKIX
(3) Calculated using the reported effective tax rate for the periods presented less impact of discrete items
Harmony Biosciences Investor Contact:
Luis Sanay, CFA
445-235-8386
lsanay@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
| Q2 2023 Financial and Business Update August 1, 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 Growth For WAKIX® in Adult Narcolepsy Significant Progress Across Lifecycle Management Programs Strong Financial Position to Maximize Shareholder Value Harmony Continues To Be A Growth Story 3 ▪ Q2 23 WAKIX Net Revenue of $134.2M +25% Year-over-Year Growth ▪ Highest top line prescription demand since our first full quarter of launch in Q1 20 ▪ Strongest quarter of new patient starts in our history ▪ Q2 23: ~5,450 average number of patients on WAKIX; ~5,600 exiting patients on WAKIX ▪ Catalyst rich second half of 2023 ▪ Q4 23: Phase 3 Topline Data in IH (INTUNE Study) ▪ Q4 23: Submit Pediatric Narcolepsy sNDA ▪ Q4 23: Initiate Phase 3 Study in PWS ▪ Q4 23: Phase 2 POC Topline Data in DM1 ▪ 2H 23: New Pitolisant Assets Update ▪ Profitable, cash generating with $429.6M on the balance sheet ▪ Debt refinancing provides greater financial flexibility ▪ Well positioned to execute on business development to build out robust portfolio ▪ Authorized $125M share repurchase program |
| WAKIX® Net Revenue Performance $107.0 $134.2 Q2 22 Q2 23 4 WAKIX QUARTERLY NET REVENUE ($M) CONFIDENT IN WAKIX BECOMING A $1B+ OPPORTUNITY IN ADULT NARCOLEPSY, WITH THE POTENTIAL TO CONTRIBUTE UP TO AN ADDITIONAL $1B, IF APPROVED IN IDIOPATHIC HYPERSOMNIA AND OTHER CURRENT LIFECYCLE MANAGEMENT PROGRAMS 25% Q2 23 HIGHLIGHTS ▪ Q2 23 Net Revenue of $134.2M ▪ Underlying demand drove continued double-digit revenue growth of 25% vs. Q2 22 ▪ Strong patient interest ▪ Continue to add new prescribers and grow WAKIX prescriber base ▪ Q2 23 Net Revenue also reflects specialty pharmacy buying patterns resulting in lower trade inventory levels at the end of the quarter |
| 5 +300 +300 +400 +300 +300 +100 +400 +300 +300 +200 +350 2,200 ~5,450 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 Average # of Patients Net Patient Additions Strong Continued 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 Q2 23 HIGHLIGHTS ▪ Average Number of Patients on WAKIX increased to ~5,450 ▪ +350 from Q1 23 ▪ Highest top line prescription demand since first full quarter of launch in Q1 20 ▪ Highest number of new patient starts in our history ▪ Continued growth in depth and breadth of prescriber base beyond HCPs enrolled in oxybate REMS program ▪ Strong payer coverage to support continued growth ~5,450 Average Number of Patients on WAKIX in Q2 23 |
| 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, June 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 Bioprojetsubmitted 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) Topline data 4Q2023 Pediatric Narcolepsy1 Submit sNDA 4Q2023 Preclinical POC study initiated 3Q2022 Development Pipeline New Pitolisant Assets 7 New Bioprojet Agreement Closed 3Q2022 Initiate Ph3 4Q2023 |
| Advancing Our Pipeline: Catalyst Rich Second Half of 2023 Event Timing Phase 3 Topline Data in IH (INTUNE Study) Q4 23 Submit Pediatric Narcolepsy sNDA Q4 23 Initiate Phase 3 Study in PWS Q4 23 Phase 2 POC Topline Data in DM1 Q4 23 New Pitolisant Assets Update 2H 23 MULTIPLE VALUE CREATING CATALYSTS 8 |
| $258.9 $316.0 $345.7 $392.4 $429.6 Jun 30 '22 Sep 30 '22 Dec 31 '22 Mar 31 '23 Jun 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) $107.0 $134.2 Q2 2022 Q2 2023 $34.7 $45.9 Q2 2022 Q2 2023 25% Net Product Revenues 32% |
| (In millions, USD) Three Months Ended June 30, % Change 2023 2022 Net Product Revenues $134.2 $107.0 25% Cost of Product Sold 25.0 18.9 32% Total Operating Expenses $62.3 $55.0 13% R&D Expense 15.0 12.7 18% S&M Expense 24.5 20.2 22% G&A Expense 22.8 22.2 3% Net Income $34.3 $23.5 46% Cash, cash equivalents & investment securities $429.6 Financial Summary Totals may not foot due to rounding 10 |
| (In millions, USD) Three Months Ended June 30, 2023 2022 GAAP net income $34.3 $23.5 Non-cash interest expense(1) 0.4 0.4 Depreciation 0.1 0.1 Amortization(2) 6.0 6.0 Stock-based compensation expense 7.8 7.4 Income tax effect related to Non-GAAP adjustments(3) (2.7) (2.7) Non-GAAP adjusted net income $45.9 $34.7 GAAP net income per diluted share $0.56 $0.39 Non-GAAP adjusted net income per diluted share $0.76 $0.57 Weighted average number of shares of common stock used in non-GAAP diluted per share 60,743,953 60,922,672 GAAP vs NON-GAAP Reconciliation (1) Includes amortization of deferred finance charges (2) Includes amortization of intangible asset related to WAKIX (3) 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 Significant Progress Across Pitolisant LCM, New Pitolisant Assets, Catalyst Rich 2H 23 Strong Financial Position ($430M) to Maximize Shareholder Value Harmony Continues To Be A Growth Story Up to $1B Opportunity in Pitolisant LCM Programs (IH, PWS, DM1) 12 |
| Thank You |
