Catalyst Pharmaceuticals Announces Fourth Quarter and Year-End 2020 Financial Results and Provides Corporate Update
- Firdapse® Q4-20 Net Revenues of
- GAAP Net Income of
- Company to Host Quarterly Conference Call at
“We are extremely pleased with our continued commercial execution of the Firdapse® launch during 2020. Despite the challenges of dealing with COVID-19, we were able grow our revenues 16% during 2020 over 2019. As the country and physician practices are starting to re-open as we enter a post-pandemic period, we believe that we are well positioned to accelerate our rate of growth with new patient starts and revenue as the year progresses,” said
Q4-20 and FY-20 Financial Results
- Total revenue, net in Q4-20 was
$31.0 million, compared to $30.1 millionfor Q4-19. Total revenue, net for FY 2020 was $119.1 million, compared to $102.3 millionfor FY 2019, an increase of 16% year over year.
- Operating income in Q4-20 was
$8.6 million, compared to $8.0 millionin Q4-19. Operating income in FY-20 was $41.3 million, compared to $31.8 millionin FY-19, an increase of 30% year over year.
- Net income in Q4-20 was
$11.4 million, or $0.11per basic and diluted share, compared with net income in Q4-19 of $7.9 million, or $0.08per basic and $0.07per diluted share. Net income in FY-20 was $75.0 million, or $0.72per basic and $0.71per diluted share, compared with net income in FY-19 of $31.9 million, or $0.31per basic and $0.30per diluted share.
- Net income for FY-2020 includes
$33.1 million( $0.32per basic and $0.31per diluted share) of tax benefit from recording the deferred tax asset, including the reversal of the valuation allowance in Q3-20.
- Research and development expenses for Q4-20 were
$4.2 millionas compared to $6.3 millionfor Q4-19. Research and development expenses for FY-20 were $16.5 millionas compared to $18.8 millionfor FY-19.
- Selling, general and administrative expenses for Q4-20 were
$13.4 million, compared to $11.4 millionin Q4-19. Selling, general and administrative expenses for FY-20 were $44.2 million, compared to $36.9 millionin FY-19.
- Ended 2020 with
$140.3 millionin cash and investments and no funded debt.
Corporate Highlights and Milestones
- Achieved record revenues for Firdapse® in treating adult LEMS patients.
- Initial patent was issued in the fourth quarter of 2020 for the use of 3,4-diaminopyridine (the patent expires in 2034 with four other patents pending in that estate).
- Expansion of the company's strategic focus to include acquiring or in-licensing innovative, technology platforms and earlier stage programs in other therapeutic categories outside of neuromuscular diseases.
- Commenced a national search for a key executive, a Chief Product Development Officer, to strategically develop and manage portfolio planning and R&D activities.
- Actively engaged in evaluation of potential acquisition of products or companies.
Other Firdapse® Development Programs
- Firdapse® long-acting formulation development program continues on schedule, with additional PK work expected to be conducted during 2021.
- A proof-of-concept study evaluating Firdapse® as a treatment for Hereditary Neuropathy with Liability to Pressure Palsies (HNPP) is scheduled to start in the third quarter of 2021.
- Plans to present MuSK-MG Firdapse® study hypotheses and a revised protocol to the FDA for discussion during the first half of 2021.
- Issued a no travel and remote work policy for all Catalyst employees on
March 16th of last year that has been partially rescinded on a regional basis as reopening has begun.
- Diligently working to reduce COVID-19 impact on new patient starts, enrollments and revenues.
- We believe that our current base of LEMS patients on reimbursed Firdapse® remains fairly stable and very compliant to their medication regimen.
- Have not experienced any disruptions in the supply chain or production of Firdapse® and believe the safety stock of Firdapse® is more than adequate for current anticipated needs.
- Proudly partnered with First Responder’s Children’s
Foundation/COVID-19 Emergency Response Fund, which provides emergency grants to support frontline emergency and healthcare workers and their families enduring financial hardship during this COVID-19 pandemic.
Balance Sheet and Key Activities in 2021
The Company plans to continue investing in the following key activities in 2021:
- Expansion of investments in research and development, including acquiring earlier stage rare disease opportunities and innovative technology.
- Expanding, prosecuting and protecting our portfolio of intellectual property.
- Expansion of
U.S.commercialization of Firdapse®.
- On-going development programs evaluating Firdapse® for the treatment of MuSK-MG and HNPP.
- Continue support for our Firdapse® long-acting formulation.
Japanregulatory activities to seek marketing authorization for Firdapse®.
More detailed financial information and analysis may be found in the Company's Annual Report on Form 10-K, which was filed with the
Non-GAAP Financial Measure
Excluding expenses related to stock-based compensation of
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 impact of the effects of the COVID-19 pandemic on Catalyst’s revenues and on the timeline for our trials or proof-of-concept studies, (ii) whether, even if Catalyst continues to be successful in commercializing Firdapse®, Catalyst will continue to achieve sustained positive cash flow and profitability, (iii) the effect on Catalyst’s business and future results of operations of the approval by the FDA of Ruzurgi® for the treatment of pediatric LEMS patients (ages 6 to under 17); (iv) whether Catalyst's suit against the FDA seeking to vacate the
1 Statements made in this press release include a non-GAAP financial measure. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with
|CONSOLIDATED STATEMENTS OF OPERATIONS|
For the Three Months
|For the Year
|Product revenue, net||$||30,832,723||$||30,122,555||$||118,740,617||$||102,306,337|
|Revenues from collaborative arrangements||182,186||--||332,186||--|
|Operating costs and expenses:|
|Cost of sales||4,869,658||4,398,265||17,039,157||14,759,139|
|Research and development||4,175,028||6,308,390||16,496,715||18,842,752|
|Selling, general and administrative||13,352,387||11,409,213||44,233,754||36,881,187|
|Total operating costs and expenses||22,397,073||22,115,868||77,769,626||70,483,078|
|Operating income (loss)||8,617,836||8,006,687||41,303,177||31,823,259|
|Other income, net||105,828||398,683||586,897||1,585,774|
|Net income (loss) before income taxes||8,723,664||8,405,370||41,890,074||33,409,033|
|Income tax provision (benefit)||(2,713,467||)||475,657||(33,092,926||)||1,533,696|
|Net income (loss)||$||11,437,131||$||7,929,713||$||74,983,000||$||31,875,337|
|Net income (loss) per share:|
|Weighted average shares outstanding:|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||130,237,109||$||89,511,710|
|Accounts receivable, net||5,987,426||10,536,997|
|Prepaid expenses and other current assets||8,327,771||4,351,074|
|Total current assets||159,243,974||111,363,623|
|Operating lease right-of-use asset||--||793,252|
|Property and equipment, net||129,800||210,467|
|Deferred tax assets||32,971,264||--|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||18,500,267||19,981,295|
|Total current liabilities||22,756,287||24,098,742|
|Operating lease liability, net of current portion||--||647,532|
|Total stockholders’ equity||169,597,639||87,629,956|
|Total liabilities and stockholders’ equity||$||192,353,926||$||112,376,230|
Brian KorbSolebury Trout (646) 378-2923 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com Media Contact David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.