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 May 2, 2023, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 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 May 2, 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.
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: May 2, 2023 | By: | /s/ Sandip Kapadia |
Sandip Kapadia | ||
Chief Financial Officer | ||
HARMONY BIOSCIENCES REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATES
WAKIX® (pitolisant) Net Revenue Increased ~40% Year-over-Year to $119.1 Million for First Quarter 2023
Average Number of Patients on WAKIX Increased ~1,200 Year-over-Year to ~5,100 for First Quarter 2023
Exited First Quarter 2023 With ~5,200 Patients on WAKIX
WAKIX Surpassed $1 Billion in Cumulative Net Revenue Since Launch
Anticipate Topline Data in Fourth Quarter 2023 in Phase 3 Idiopathic Hypersomnia (“IH”) INTUNE Study Given Continued Strong Momentum
Conference Call and Webcast to be Held Today at 8:30 a.m. ET
PLYMOUTH MEETING, Pa., May 2, 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 March 31, 2023.
“We are pleased to report another quarter of strong performance and operational excellence across our business. We saw continued momentum in our commercial business for WAKIX, as well as in the advancement of our clinical development programs for pitolisant,” stated Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony.
“WAKIX commercial performance reflects its unique and meaningfully differentiated product profile, allowing us to reach an important milestone of surpassing $1 billion in cumulative net revenue within the first three and half years since launch, one of the
most successful launches ever for a rare disease company. We have demonstrated strong and continued growth since the launch of WAKIX and remain a growth story, given the vast opportunity that remains in the narcolepsy market, the potential of our current life cycle management programs, new formulations of pitolisant that are being developed, and growth through business development.”
First Quarter 2023 Financial Results
Net product revenues for the quarter ended March 31, 2023 were $119.1 million, compared to $85.3 million for the same period in 2022. The 39.6% growth versus the same period in 2022 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand. The average number of patients on WAKIX increased by approximately 1,200 patients from the quarter ended March 31, 2022 to approximately 5,100 as of the quarter ended March 31, 2023. Exited the quarter ended March 31, 2023, with approximately 5,200 patients on WAKIX.
GAAP net income for the quarter ended March 31, 2023, was $29.5 million, or $0.48 earnings per diluted share, compared to GAAP net income of $21.5 million, or $0.35 earnings per diluted share, for the same period in 2022. Non-GAAP adjusted net income was $40.1 million, or $0.66 earnings per diluted share, for the quarter ended March 31, 2023, compared to Non-GAAP adjusted net income of $31.1 million, or $0.51 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 $13.3 million in the first quarter of 2023, as compared to $7.6 million for the same quarter in 2022, representing a 75.4% increase; |
| ● | Sales and Marketing expenses were $22.6 million in the first quarter of 2023, as compared to $17.6 million for the same quarter in 2022, representing a 28.4% increase; |
| ● | General and Administrative expenses were $22.1 million in the first quarter of 2023, as compared to $17.9 million for the same quarter in 2022, representing a 23.4% increase; and |
| ● | Total Operating Expenses were $57.9 million in the first quarter of 2023, as compared to $43.0 million for the same quarter in 2022, representing a 34.6% increase. |
As of March 31, 2023, Harmony had cash, cash equivalents and investment securities of $392.4 million, compared to $345.7 million as of December 31, 2022.
Company Updates
| ● | Jeffrey M. Dayno, MD, was appointed President and Chief Executive Officer in April 2023. Dr. Dayno was also elected to join as a member of Harmony’s Board of Directors. |
| ● | Kumar Budur, MD, MS, was appointed Chief Medical Officer in May 2023. Dr. Budur most recently served as Senior Vice President and Head of Clinical Development for Harmony. |
| ● | Continued strong momentum in the Phase 3 registrational trial (INTUNE Study) in adult patients with IH, with topline data anticipated in the fourth quarter of 2023. |
| ● | End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) scheduled for late second quarter of 2023 to discuss the Prader-Willi Syndrome (“PWS”) Phase 2 proof-of-concept study results and a proposed Phase 3 trial in patients with PWS. |
| ● | Enrollment continues in our Myotonic Dystrophy (“DM1”) study. We anticipate topline data from this Phase 2 proof-of-concept trial in the fourth quarter of 2023. |
| ● | On March 15, 2023, our partner Bioprojet received approval of a pediatric narcolepsy indication from the European Medicines Agency. We are working with Bioprojet on the submission to FDA of a supplemental new drug application for pediatric narcolepsy. |
| ● | Regarding pediatric exclusivity, we are working with FDA to gain alignment in pursuit of pediatric exclusivity for WAKIX. |
Conference Call Today at 8:30 a.m. ET
We are hosting our first quarter 2023 financial results conference call and webcast today, beginning 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) 343-4136 (domestic) or +1 (203) 518-9843 (international), and reference passcode HRMYQ123.
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 impact of the COVID-19 pandemic, including any current and future variants; 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; 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 March 31, | ||||
|
| 2023 |
| 2022 | ||
Net product revenues | | $ | 119,126 | | $ | 85,313 |
Cost of product sold | |
| 20,780 | |
| 14,716 |
Gross profit | |
| 98,346 | |
| 70,597 |
Operating expenses: | |
|
| |
|
|
Research and development | |
| 13,289 | |
| 7,578 |
Sales and marketing | |
| 22,572 | |
| 17,583 |
General and administrative | |
| 22,062 | |
| 17,880 |
Total operating expenses | |
| 57,923 | |
| 43,041 |
Operating income | |
| 40,423 | |
| 27,556 |
Other income (expense), net | |
| 2 | |
| (2) |
Interest expense, net | |
| (2,645) | |
| (4,169) |
Income before income taxes | |
| 37,780 | |
| 23,385 |
Income tax expense | |
| (8,295) | |
| (1,900) |
Net income | | $ | 29,485 | | $ | 21,485 |
Unrealized gain on investments | |
| 120 | |
| — |
Comprehensive income | | $ | 29,605 | | $ | 21,485 |
EARNINGS PER SHARE: | |
|
| |
|
|
Basic | | $ | 0.49 | | $ | 0.36 |
Diluted | | $ | 0.48 | | $ | 0.35 |
Weighted average number of shares of common stock - basic | |
| 59,732,157 | |
| 58,908,526 |
Weighted average number of shares of common stock - diluted | |
| 61,221,511 | |
| 60,586,875 |
| | | | | | |
HARMONY BIOSCIENCES HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands except share and per share data)
|
| March 31, |
| December 31, | ||
|
| 2023 |
| 2022 | ||
ASSETS |
| |
|
| |
|
CURRENT ASSETS: |
| |
|
| |
|
Cash and cash equivalents | | $ | 287,962 | | $ | 243,784 |
Investments, short-term | | | 55,916 | | | 79,331 |
Trade receivables, net | |
| 52,575 | |
| 54,740 |
Inventory, net | |
| 4,090 | |
| 4,297 |
Prepaid expenses | |
| 11,399 | |
| 9,347 |
Other current assets | |
| 6,145 | |
| 8,786 |
Total current assets | |
| 418,087 | |
| 400,285 |
NONCURRENT ASSETS: | |
|
| |
|
|
Property and equipment, net | |
| 470 | |
| 573 |
Restricted cash | |
| 750 | |
| 750 |
Investments, long-term | | | 48,538 | | | 22,568 |
Intangible assets, net | |
| 154,992 | |
| 160,953 |
Deferred tax asset | | | 89,385 | | | 85,943 |
Other noncurrent assets | |
| 2,870 | |
| 2,798 |
Total noncurrent assets | |
| 297,005 | |
| 273,585 |
TOTAL ASSETS | | $ | 715,092 | | $ | 673,870 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
|
| |
|
|
CURRENT LIABILITIES: | |
|
| |
|
|
Trade payables | | $ | 6,414 | | $ | 3,786 |
Accrued compensation | |
| 5,691 | |
| 11,532 |
Accrued expenses | |
| 56,810 | |
| 59,942 |
Current portion of long-term debt | | | 6,500 | | | 2,000 |
Other current liabilities | |
| 9,948 | |
| 1,624 |
Total current liabilities | |
| 85,363 | |
| 78,884 |
NONCURRENT LIABILITIES: | |
|
| |
|
|
Long-term debt, net | |
| 185,063 | |
| 189,647 |
Other noncurrent liabilities | |
| 1,625 | |
| 2,501 |
Total noncurrent liabilities | |
| 186,688 | |
| 192,148 |
TOTAL LIABILITIES | |
| 272,051 | |
| 271,032 |
COMMITMENTS AND CONTINGENCIES (Note 12) | |
|
| |
|
|
STOCKHOLDERS’ EQUITY: | |
|
| |
|
|
Common stock—$0.00001 par value; 500,000,000 shares authorized at March 31, 2023 and December 31, 2022, respectively; 59,954,618 shares and 59,615,731 issued and outstanding at March 31, 2023 and December 31, 2022, respectively | |
| 1 | |
| 1 |
Additional paid in capital | |
| 685,716 | |
| 675,118 |
Accumulated other comprehensive income (loss) | | | (31) | | | (151) |
Accumulated deficit | |
| (242,645) | |
| (272,130) |
TOTAL STOCKHOLDERS’ EQUITY | |
| 443,041 | |
| 402,838 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 715,092 | | $ | 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 | | ||||
| | March 31, | | March 31, | | ||
| | 2023 | | 2022 | | ||
GAAP net income | | $ | 29,485 | | $ | 21,485 | |
Non-GAAP Adjustments: | |
|
| |
|
| |
Non-cash interest expense (1) | |
| 416 | |
| 412 | |
Depreciation | |
| 103 | |
| 117 | |
Amortization (2) | |
| 5,961 | |
| 5,082 | |
Stock-based compensation expense | |
| 6,561 | |
| 4,896 | |
Income tax effect related to non-GAAP adjustments (3) | |
| (2,400) | |
| (854) | |
Non-GAAP adjusted net income | | $ | 40,126 | | $ | 31,138 | |
| | | | | | | |
GAAP reported net income per diluted share | | $ | 0.48 | | $ | 0.35 | |
Non-GAAP adjusted net income per diluted share | | $ | 0.66 | | $ | 0.51 | |
| | | | | | | |
Weighted average number of shares of common stock used in non-GAAP diluted per share | |
| 61,221,511 | |
| 60,586,875 | |
(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
| Q1 2023 Financial and Business Update May 2, 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. |
| DESIGNED TO SUPPORT LONG TERM SUSTAINABLE GROWTH Our Corporate Growth Strategy Optimize WAKIX® Performance Expand Clinical Utility of Pitolisant 3 Acquire New Assets |
| WAKIX® Net Revenue Performance $6.0 $19.8 $38.0 $45.6 $56.3 $59.7 $73.8 $80.7 $91.2 $85.3 $107.0 $117.2 $128.4 $119.1 Q4 19 Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 4 WAKIX QUARTERLY NET REVENUE ($M) CONFIDENT IN WAKIX BECOMING A POTENTIAL $1B+ NARCOLEPSY OPPORTUNITY, WITH THE POTENTIAL TO CONTRIBUTE UP TO AN ADDITIONAL $1B, IF APPROVED IN IDIOPATHIC HYPERSOMNIA AND OTHER CURRENT LIFECYCLE MANAGEMENT PROGRAMS 40% HIGHLIGHTS ▪ Strong revenue growth of 40% vs. Q1 22 ▪ WAKIX Surpassed $1 Billion in Cumulative Net Revenue Since Launch ▪ March 2023, the highest month of top-line prescription demand for WAKIX in over three years and the strongest month of new patient starts in a year |
| U.S. Covered Lives With Formulary Access >80% Average # of Patients on WAKIX ~5,100 Continued Growth in Depth & Breadth of Prescriber Base ~85% In-Person Access to HCPs Driving Growth Through Strong Commercialization of WAKIX® Q1 2023 Performance 5 |
| Product / Indication Pre-IND Phase 1 Phase 2 Phase 3 Regulatory Filing1 Marketed Product Milestone Pitolisant Topline data 4Q2023 1. Includes New Drug Applications and supplemental New Drug Applications. 2. 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 Narcolepsy2 EMA Approval 1Q2023 Preclinical POC study initiated 3Q2022 Development Pipeline New Pitolisant Assets 6 New Bioprojet Agreement Closed 3Q2022 FDA EoP2 Meeting Late 2Q2023 |
| $224.5 $258.9 $316.0 $345.7 $392.4 Mar 31 '22 Jun 30 '22 Sep 30 '22 Dec 31 '22 Mar 31 '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) 7 Cash, Cash Equivalents & Investment Securities Non-GAAP Adjusted Net Income(1) $85.3 $119.1 Q1 2022 Q1 2023 $31.1 $40.1 Q1 2022 Q1 2023 40% Net Product Revenues 29% |
| (In millions, USD) Three Months Ended March 31, % Change 2023 2022 Net Product Revenues $119.1 $85.3 40% Cost of Product Sold 20.8 14.7 41% Total Operating Expenses $57.9 $43.0 35% R&D Expense 13.3 7.6 75% S&M Expense 22.6 17.6 28% G&A Expense 22.1 17.9 23% Net Income $29.5 $21.5 37% Cash, cash equivalents & investment securities $392.4 Financial Summary Totals may not foot due to rounding 8 |
| (In millions, USD) Three Months Ended March 31, 2023 2022 GAAP net income $29.5 $21.5 Non-cash interest expense(1) 0.4 0.4 Depreciation 0.1 0.1 Amortization(2) 6.0 5.1 Stock-based compensation expense 6.6 4.9 Income tax effect related to Non-GAAP adjustments(3) (2.4) (0.9) Non-GAAP adjusted net income $40.1 $31.1 GAAP net income per diluted share $0.48 $0.35 Non-GAAP adjusted net income per diluted share $0.66 $0.51 Weighted average number of shares of common stock used in non-GAAP diluted per share 61,221,511 60,586,875 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 valuation allowance release and discrete items Totals may not foot due to rounding 9 |
| Strong Commercial Performance & Future Growth of WAKIX in Narcolepsy New Development Programs to Expand Portfolio, Treatment Options Talented Team & Solid Balance Sheet Positioned for Next Level of Growth Harmony Continues To Be A Growth Story Poised to Extend Pitolisant Value Proposition Beyond Narcolepsy with IH, PWS & DM 10 |
| Thank You |
