Catalyst Pharmaceuticals Announces Second Quarter 2021 Financial Results and Provides Corporate Update
-Q2 2021 Total Net Revenues of
-Q2 2021 GAAP Net Income of
-Catalyst to Host Quarterly Conference Call at
“I am very pleased that our operational plan for 2021 and year to date financial results continue to deliver as originally planned, despite not yet being back to pre-Covid conditions. I believe that this portends well for the balance of the year, as we anticipate that patient access to physician practices will continue to improve. This should lead to abbreviated diagnostic times for new Lambert-Eaton Myasthenic Syndrome (LEMS) patients, which will mean that these patients will have access to Firdapse® much sooner,” said
Q2-21 Financial Results
- Total revenues in Q2 2021 were
$36.4 million, a 23% increase from $29.6 millionfor Q2 2020.
- Total Firdapse® product revenue, net in Q2 2021 was
$33.6 million, a 14% increase from $29.6 million, net for Q2 2020.
- Operating income in Q2 2021 was
$15.8 million, up from $10.3 millionin Q2 2020.
- GAAP net income in Q2 2021 was
$12.2 million, or $0.12per basic and $0.11per diluted share, compared with GAAP net income in Q2 2020 of $9.8 million, or $0.09per basic and diluted share.
- Research and development expenses were
$4.5 millionfor Q2 2021 compared to $4.4 millionfor Q2 2020.
- Selling, general and administrative expenses for Q2 2021 totaled
$11.5 millioncompared to $10.8 millionfor Q2 2020.
- During Q2 2021, repurchased 732,951 shares of the Company’s common stock for approximately
- Ended Q2 2021 with
$155.3 millionin cash and investments and no funded debt.
- Announced exclusive license and supply agreement with DyDo Pharma for the development and commercialization of Firdapse® in
July 2021, strengthened our senior leadership team with onboarding of Dr. Preethi Sundaramas Chief Product Development Officer, who will lead our product portfolio development and management.
- Expanded our strategic focus to include acquiring or in-licensing innovative, technology platforms and earlier stage programs in all therapeutic categories with the exclusion of oncology.
- Actively engaged in evaluation of potential acquisitions and partnerships of innovative products or companies.
- Second Firdapse® patent issued, further strengthening our intellectual property portfolio.
Molly Harper, a seasoned pharmaceutical executive, to our board of directors.
- Hired a new Vice President to lead investor relations. This executive will join us on
August 16, 2021.
Balance Sheet and Key Activities in 2021
The Company plans to continue investing in the following key activities in 2021:
- Expansion of
U.S.commercialization of Firdapse®.
- Continue support for our Firdapse® long-acting formulation and other development programs.
- Expanding, prosecuting and protecting our portfolio of intellectual property.
- Expansion of investments in research and development, including acquiring earlier stage rare disease opportunities and innovative technology.
More detailed financial information and analysis can be found in the Company's Quarterly Report on Form 10-Q, which was filed with the
Non-GAAP Financial Measures
Non-GAAP1 net income for Q2-21 was
1 Statements made in this press release include non-GAAP financial measures. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with
The non-GAAP financial measures in this press release exclude from the calculation of net income (i) the expense associated with non-cash stock-based compensation, (ii) depreciation expense, and (iii) the provision for income taxes. Non-GAAP income per share is calculated by dividing non-GAAP income by the weighted average common shares outstanding.
Catalyst management will host an investment-community conference call and webcast at
Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and has received Orphan Drug Designation from the FDA for myasthenia gravis.
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) the continuing effect of the COVID-19 pandemic on Catalyst's net product revenues and net income, (ii) Catalyst’s ability to locate and acquire new product candidates through acquisition or in-licensing, (iii) Catalyst’s ability to successfully develop any new product candidates acquired or in-licensed, (iv) Catalyst’s ability to successfully develop Firdapse® for other indications and to successfully develop and commercialize a long acting formulation of Firdapse®, and (v) those factors described in Catalyst's Annual Report on Form 10-K for fiscal year 2020 and Catalyst's other filings with the
|CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)|
|(in thousands, except share data)|
|For the Three Months
|For the Six Months
|Product revenue, net||$||33,636||$||29,605||$||63,841||$||58,741|
|License and other revenue||2,729||--||2,729||--|
|Operating costs and expenses:|
|Cost of sales||4,545||4,140||9,226||8,291|
|Research and development||4,450||4,350||7,457||8,573|
|Selling, general and administrative||11,532||10,833||24,248||20,896|
|Total operating costs and expenses||20,527||19,323||40,931||37,760|
|Other income, net||62||111||143||448|
|Net income before income taxes||15,900||10,393||25,782||21,429|
|Provision for income taxes||3,719||613||5,938||1,223|
|Net income per share:|
|Weighted average shares outstanding:|
RECONCILIATION OF NON-GAAP METRICS (unaudited)
|(in thousands, except share data)|
|For the Three Months
||For the Six Months|
|GAAP net income||$||12,181||$||9,780||$||19,844||$||20,206|
|Stock-based compensation expense||1,518||1,794||3,089||3,314|
|Income tax provision||3,719||613||5,938||1,223|
|Non-GAAP net income||$||17,449||$||12,216||$||28,999||$||24,786|
|Non-GAAP net income per share:|
|Weighted average shares outstanding – basic||103,407,803||103,414,523||103,610,138||103,410,881|
|Weighted average shares outstanding – diluted||107,734,924||106,730,423||107,299,262||106,433,862|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||135,295||$||130,237|
|Accounts receivable, net||6,292||5,987|
|Prepaid expenses and other current assets||7,641||8,328|
|Total current assets||176,305||159,244|
|Operating lease right-of-use asset||3,201||--|
|Property and equipment, net||914||130|
|Deferred tax assets||28,701||32,971|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||13,211||18,500|
|Total current liabilities||16,135||22,756|
|Operating lease liability, net of current portion||4,051||--|
|Total stockholders’ equity||188,944||169,598|
|Total liabilities and stockholders’ equity||$||209,130||$||192,354|
David Schull Russo Partners(212) 845-4271 email@example.com Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.