Full Press Release Details
Catalyst Pharmaceuticals Announces Third Quarter 2020 Financial Results and Provides Business Update
- Firdapse Third Quarter Net Revenues of $29.2 Million
- Company Ends Third Quarter with $127.1 Million in Cash and Investments
- U.S. Patent Issued for Firdapse and Expires April 7, 2034
- Firdapse Approved in Canada in the Third Quarter and Recently Launched
- Company to Host Quarterly Conference Call at 8:30 am ET Tomorrow
CORAL GABLES, Fla., November 09, 2020 (GLOBE NEWSWIRE) Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a commercial-stage biopharmaceutical
company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today reported financial results for the third quarter ended September 30, 2020 and
provided a business update.
I am pleased to report on a very productive third quarter and on our continued commercial execution under challenging
conditions and remain confident that we will continue to see more success as physicians and other providers adapt to this virtual working environment. Also, we are very encouraged by the number of new LEMS patient starts that were initiated over the
past 2 months and are hopeful that this is the beginning of a trend, said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. Mr. McEnany added, Additionally, during the third quarter we were
excited to announce the issuance of our U.S. patent for Firdapse , which we believe significantly fortifies our intellectual property position. We continue to work diligently alongside
partners to protect Firdapse and to ensure that we are able to advance and make available therapeutics for patients suffering from rare neurological conditions.
Q3-20 Financial Results
Corporate Highlights and Milestones
Other Firdapse Development Programs
Balance Sheet and Key Activities in 2020
At September 30, 2020, Catalyst had cash and cash equivalents and investments of $127.1 million and no funded debt.
The Company plans to continue investing in the following key activities in 2020 and 2021:
More detailed financial information and analysis may be found in the
Company s Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission (SEC) on November 9, 2020.
Non-GAAP Financial Measures
Excluding expenses related to stock-based compensation of $1.5 million, non-GAAP1 net income for the third quarter of 2020 was $44.8 million, or $0.43 per basic and $0.42 per diluted share. This compares to non-GAAP1 net income of $14.4 million, or $0.14 per basic share and $0.13 per diluted share, excluding stock-based compensation expense of $817 thousand, for the third quarter of 2019. Excluding
expenses related to stock-based compensation of $4.8 million, non-GAAP1 net income for the nine months ended September 30, 2020 was
$68.3 million, or $0.66 per basic share and $0.64 per diluted share. This compares to a non-GAAP1 net income of $26.6 million, or $0.26 per basic
and $0.25 per diluted share, excluding stock-based compensation expense of $2.7 million, for the nine months ended September 30, 2019.
Catalyst management will host an
investment-community conference call and webcast at 8:30 a.m. ET, tomorrow, Tuesday, November 10, 2020 to discuss the financial results and provide a corporate update. Investors who wish to participate in the conference call may do so by
dialing (877) 407-8912 for domestic and Canadian callers or (201) 689-8059 for international callers. Those interested in listening to the conference call live via the
internet may do so by visiting the Investors page of the company s website at www.catalystpharma.com and clicking on the webcast link on the Investors home page. A webcast replay will be available on the Catalyst website for 30 days
following the call by visiting the Investor page of the company s website at www.catalystpharma.com.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people
with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy
(SMA) Type 3. Catalyst s new drug application for
Firdapse (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration ( FDA ), and
Firdapse is commercially available in the United States. Further, Canada s national healthcare regulatory agency, Health Canada, recently approved the use of Firdapse (amifampridine) for the treatment of patients in Canada with LEMS.
Firdapse is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 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 2020
net product revenues and on the timeline for reporting the top-line results from Catalyst s SMA Type 3 proof-of-concept
study, (ii) whether, even if Catalyst is successful in commercializing Firdapse , Catalyst will 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 FDA s approval of Ruzurgi will ultimately be successful; (v) whether Firdapse
will ever be approved for commercialization for the treatment of MuSK-MG, SMA Type 3, or any other disease, and (vi) those other factors described in Catalyst s Annual Report on Form 10-K for the fiscal year 2019 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst s filings with the SEC are available from the SEC,
may be found on Catalyst s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
CATALYST PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 29,166,658 | $ | 30,897,444 | $ | 87,907,894 | $ | 72,183,782 | ||||||||
| Revenues from collaborative arrangements | 150,000 | 150,000 | ||||||||||||||
| Total revenues | 29,316,658 | 30,897,444 | 88,057,894 | 72,183,782 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of sales | 3,878,760 | 4,387,461 | 12,169,499 | 10,360,874 | ||||||||||||
| Research and development | 3,749,233 | 4,597,039 | 12,321,687 | 12,534,362 | ||||||||||||
| Selling, general and administrative | 9,984,961 | 8,067,792 | 30,881,367 | 25,471,974 | ||||||||||||
| Total operating costs and expenses | 17,612,954 | 17,052,292 | 55,372,553 | 48,367,210 | ||||||||||||
| Operating income (loss) | 11,703,704 | 13,845,152 | 32,685,341 | 23,816,572 | ||||||||||||
| Other income, net | 33,567 | 393,415 | 481,069 | 1,187,091 | ||||||||||||
| Net income (loss) before income taxes | 11,737,271 | 14,238,567 | 33,166,410 | 25,003,663 | ||||||||||||
| Income tax provision (benefit) | (31,602,596 | ) | 608,388 | (30,379,459 | ) | 1,058,039 | ||||||||||
| Net income (loss) | $ | 43,339,867 | $ | 13,630,179 | $ | 63,545,869 | $ | 23,945,624 | ||||||||
| Net income (loss) per share: | ||||||||||||||||
| Basic | $ | 0.42 | $ | 0.13 | $ | 0.61 | $ | 0.23 | ||||||||
| Diluted | $ | 0.41 | $ | 0.13 | $ | 0.60 | $ | 0.23 | ||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 103,535,431 | 102,974,105 | 103,452,025 | 102,864,571 | ||||||||||||
| Diluted | 106,316,241 | 107,045,234 | 106,386,617 | 105,821,609 |
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2020 | December 31, 2019 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 117,105,973 | $ | 89,511,710 | ||||
| Short-term investments | 10,002,749 | 5,007,050 | ||||||
| Accounts receivable, net | 5,871,893 | 10,536,997 | ||||||
| Inventory | 4,747,538 | 1,956,792 | ||||||
| Prepaid expenses and other current assets | 5,614,052 | 4,351,074 | ||||||
| Total current assets | 143,342,205 | 111,363,623 | ||||||
| Deferred tax assets | 31,347,442 | |||||||
| Operating lease right-of-use asset | 12,167 | 793,252 | ||||||
| Property and equipment, net | 149,119 | 210,467 | ||||||
| Deposits | 8,888 | 8,888 | ||||||
| Total assets | $ | 174,859,821 | $ | 112,376,230 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,005,340 | $ | 4,117,447 | ||||
| Accrued expenses and other liabilities | 16,226,609 | 19,981,295 | ||||||
| Total current liabilities | 18,231,949 | 24,098,742 | ||||||
| Operating lease liability, net of current portion | 647,532 | |||||||
| Total liabilities | 18,231,949 | 24,746,274 | ||||||
| Total stockholders equity | 156,627,872 | 87,629,956 | ||||||
| Total liabilities and stockholders equity | $ | 174,859,821 | $ | 112,376,230 |