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
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- 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 million for Q4-19. Total revenue, net for FY 2020 was$119.1 million , compared to$102.3 million for FY 2019, an increase of 16% year over year. - Operating income in Q4-20 was
$8.6 million , compared to$8.0 million in Q4-19. Operating income in FY-20 was$41.3 million , compared to$31.8 million in FY-19, an increase of 30% year over year. - Net income in Q4-20 was
$11.4 million , or$0.11 per basic and diluted share, compared with net income in Q4-19 of$7.9 million , or$0.08 per basic and$0.07 per diluted share. Net income in FY-20 was$75.0 million , or$0.72 per basic and$0.71 per diluted share, compared with net income in FY-19 of$31.9 million , or$0.31 per basic and$0.30 per diluted share. - Net income for FY-2020 includes
$33.1 million ($0.32 per basic and$0.31 per 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 million as compared to$6.3 million for Q4-19. Research and development expenses for FY-20 were$16.5 million as compared to$18.8 million for FY-19. - Selling, general and administrative expenses for Q4-20 were
$13.4 million , compared to$11.4 million in Q4-19. Selling, general and administrative expenses for FY-20 were$44.2 million , compared to$36.9 million in FY-19. - Ended 2020 with
$140.3 million in 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.
COVID-19 Impact
- Issued a no travel and remote work policy for all Catalyst employees on
March 16 th 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
At
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.
- Continue
Japan regulatory 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
Conference Call
Catalyst management will host an investment-community conference call and webcast at
About
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.
Forward-Looking Statements
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
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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 | ||||||||||||||
| (unaudited) For the Three Months Ended |
For the Year Ended |
|||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||
| Product revenue, net | $ | 30,832,723 | $ | 30,122,555 | $ | 118,740,617 | $ | 102,306,337 | ||||||
| Revenues from collaborative arrangements | 182,186 | -- | 332,186 | -- | ||||||||||
| Total revenues | 31,014,909 | 30,122,555 | 119,072,803 | 102,306,337 | ||||||||||
| 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: | ||||||||||||||
| Basic | $ | 0.11 | $ | 0.08 | $ | 0.72 | $ | 0.31 | ||||||
| Diluted | $ | 0.11 | $ | 0.07 | $ | 0.71 | $ | 0.30 | ||||||
| Weighted average shares outstanding: | ||||||||||||||
| Basic | 103,694,845 | 103,180,946 | 103,512,913 | 102,944,316 | ||||||||||
| Diluted | 105,838,449 | 106,567,001 | 106,242,273 | 106,020,936 | ||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
2020 |
2019 |
||||
| ASSETS | |||||
| Current Assets: | |||||
| Cash and cash equivalents | $ | 130,237,109 | $ | 89,511,710 | |
| Short-term investments | 10,041,068 | 5,007,050 | |||
| Accounts receivable, net | 5,987,426 | 10,536,997 | |||
| Inventory | 4,650,600 | 1,956,792 | |||
| 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 | -- | |||
| Deposits | 8,888 | 8,888 | |||
| Total assets | $ | 192,353,926 | $ | 112,376,230 | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current Liabilities: | |||||
| Accounts payable | $ | 4,256,020 | $ | 4,117,447 | |
| 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 liabilities | 22,756,287 | 24,746,274 | |||
| Total stockholders’ equity | 169,597,639 | 87,629,956 | |||
| Total liabilities and stockholders’ equity | $ | 192,353,926 | $ | 112,376,230 | |
Investor ContactBrian Korb Solebury Trout (646) 378-2923 bkorb@troutgroup.com Company ContactPatrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com Media ContactDavid Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com
Source: Catalyst Pharmaceuticals, Inc.