Harmony Biosciences Reports Third Quarter 2020 Financial Results and Business Updates
WAKIX® (pitolisant) Total Revenue of
Differentiated Product Profile Aligns with Unmet Medical Need
On Track to Initiate Phase 2 Trial in Patients with Prader-Willi Syndrome by Year End
Conference Call and Webcast to be held today at 8:30 a.m. Eastern Time
“Harmony experienced another productive quarter with continued WAKIX revenue growth and meaningful advancement of our key clinical programs,” commented
Third Quarter 2020 Financial Highlights:
- Net product revenue was
$45.6 millionfor the third quarter ended September 30, 2020.
- Research and development expenses were
$4.2 millionfor the third quarter of 2020 compared with $4.3 millionfor the third quarter of 2019.
- Sales and marketing expenses were
$12.6 millionfor the third quarter of 2020 compared with $12.9 millionfor the third quarter of 2019.
- General and administrative expenses were
$10.5 millionfor the third quarter of 2020 compared with $12.6 millionfor the third quarter of 2019.
- Net income was
$1.9 millionfor the third quarter of 2020 compared with a net loss of $31.9 millionfor the third quarter of 2019.
- Cash and cash equivalents as of
September 30, 2020was $221.7 million.
Harmony Founder and Chairman, and Paragon Biosciences Chairman and CEO,
Recent Program Highlights and Updates:
WAKIX® (pitolisant) in Narcolepsy
October 13, 2020, the U.S. Food and Drug Administration(FDA) approved WAKIX for the treatment of cataplexy in adult patients with narcolepsy. This approval expands the label for WAKIX and broadens its clinical utility for healthcare professionals managing adult patients living with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness (EDS) or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration(DEA).
Pitolisant in Patients with Prader-Willi Syndrome (PWS) and Myotonic Dystrophy (DM)
- PWS and DM are rare, genetic multi-system diseases for which there are no approved treatments for many of the symptoms, resulting in significant unmet medical needs.
• For PWS, clinical sites are being activated to conduct a Phase 2 randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of pitolisant in patients with PWS, with the primary endpoint being EDS. We are on-track to initiate this trial this year.
• For DM, we are on-track to submit an IND by year end with the plan to initiate a Phase 2 clinical trial in the first half of 2021.
Recent Business Updates:
August 21, 2020we successfully completed our upsized IPO of 6,151,162 shares of common stock at a public offering price of $24.00per share, including an exercise in full of the underwriters’ option to purchase additional shares. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $147.6 million.
- In November, we expanded the depth and breadth of our Board of Directors with the addition of
Mark Grafand Eric Motley.
Conference Call Today at
We are hosting our third quarter 2020 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 page of our website at https://ir.harmonybiosciences.com/. To participate in the live call by phone, dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 7489154. A replay will be accessible until November 19, 2020 by dialing (855) 859-2056 (domestic) or +1 (404) 537-3406 (international).
About WAKIX® (pitolisant) Tablets
WAKIX, a first-in-class medication, is approved by the
Indications and Usage
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.
Important Safety Information
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).
In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash.
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
About Harmony Biosciences
Forward Looking Statement
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 plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreement with
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands except share and per share data)
|Three Months Ended
||Nine Months Ended
|Net product revenues||$||45,609||$||—||$||103,454||$||—|
|Cost of product sold||7,890||—||17,820||—|
|Research and development||4,230||4,336||11,829||62,319|
|Sales and marketing||12,601||12,908||38,297||27,477|
|General and administrative||10,508||12,560||26,280||22,415|
|Total operating expenses||27,339||29,804||76,406||112,211|
|Operating income (loss)||10,380||(29,804||)||9,228||(112,211||)|
|Loss on debt extinguishment||—||—||(22,639||)||—|
|Other expense, net||(1,525||)||—||(3,071||)||—|
|Interest expense, net||(6,946||)||(2,095||)||(20,254||)||(3,326||)|
|Income (loss) before income taxes||1,909||(31,899||)||(36,736||)||(115,537||)|
|Net income (loss) and comprehensive loss||$||1,909||$||(31,899||)||$||(36,736||)||$||(115,537||)|
|Accumulation of dividends on preferred stock||(6,013||)||(9,027||)||(26,904||)||(25,656||)|
|Net loss available to common stockholders||$||(4,104||)||$||(40,926||)||$||(63,640||)||$||(141,193||)|
|NET LOSS PER SHARE:|
|Weighted average number of shares of common stock - basic||30,212,959||7,777,100||15,324,362||7,777,100|
|Weighted average number of shares of common stock - diluted||30,212,959||7,777,100||15,324,362||7,777,100|
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands except share and per share data)
|Cash and cash equivalents||$||221,740||$||24,457|
|Trade receivables, net||16,326||4,255|
|Other current assets||5,625||261|
|Total current assets||250,242||31,497|
|Property and equipment, net||1,038||1,330|
|Intangible asset, net||66,625||72,185|
|Other noncurrent assets||1,418||941|
|Total noncurrent assets||69,831||75,206|
|LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Other current liabilities||—||115|
|Total current liabilities||31,790||19,892|
|Long term debt, net||192,858||97,946|
|Other noncurrent liabilities||571||163|
|Total noncurrent liabilities||193,734||98,396|
|COMMITMENTS AND CONTINGENCIES (Note 9)|
|CONVERTIBLE PREFERRED STOCK|
|Convertible preferred stock, net of placement costs|
|Series A convertible preferred stock -
|Series B convertible preferred stock -
|Series C convertible preferred stock -
|STOCKHOLDERS' EQUITY (DEFICIT):|
|Preferred stock -
|Common stock -
|Additional paid in capital||582,535||—|
|TOTAL STOCKHOLDERS' EQUITY (DEFICIT)||94,549||(422,862||)|
|TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT)||$||320,073||$||106,703|
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Source: Harmony Biosciences