Full Press Release Details
Catalyst Pharmaceuticals Announces Second Quarter 2020 Financial Results and Provides Business Update
- Firdapse Second Quarter Net Revenues of $29.6 Million
- Health Canada Approves Marketing Authorization for Firdapse for Treating
- MuSK-MG Phase 3 Trial did not Achieve Statistical Significance for Primary
or Secondary Endpoints
- Company to Host Quarterly Conference Call at 8:30 am ET Tomorrow
CORAL GABLES, Fla., August 10, 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 second quarter
ended June 30, 2020 and provided a business update.
Despite operating under COVID-19 conditions, I am
quite pleased with the resiliency of our team and the operating results that were achieved during the second quarter. Additionally, as physicians practices begin to open again to in-person meetings with
patients and sales representatives, we are beginning to see an improvement in new LEMS patient enrollments in Catalyst Pathways and are hopeful that this is a start of a trend, said Patrick J. McEnany, Chairman and Chief Executive
Officer of Catalyst Pharmaceuticals. On a separate note, we are disappointed that the top-line results of our Phase 3 study for Firdapse in
anti-MuSK antibody positive myasthenia gravis patients did not replicate the robust positive results that were observed in the 2017 proof-of-concept study. We intend to
continue to analyze the data and meet with our neuromuscular key opinion leaders to decide on our path forward for this program.
Q2-20 Financial Results
Corporate Highlights and Milestones
MuSK-MG Phase 3 Study Results
Other Firdapse Development Programs
Balance Sheet and Key Activities in 2020
At June 30, 2020, Catalyst had cash and cash equivalents and investments of $115.1 million and no funded debt.
The Company plans to continue investing in the following key activities in 2020:
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 August 10, 2020.
Non-GAAP Financial Measures
Excluding expenses related to stock-based compensation of $1.8 million, non-GAAP1 net income for the second quarter of 2020 was $11.6 million, or $0.11 per basic and diluted share. This compares to a non-GAAP1 net income of $11.9 million, or $0.12 per basic share and $0.11 per diluted share, excluding stock-based compensation expense of $925 thousand, for the second quarter of 2019. Excluding
expenses related to stock-based compensation of $3.3 million, non-GAAP1 net income for the six months ended June 30, 2020 was $23.5 million,
or $0.23 per basic share and $0.22 per diluted share. This compares to a non-GAAP1 net income of $12.2 million, or $0.12 per basic and diluted share,
excluding stock-based compensation expense of $1.9 million, for the six months ended June 30, 2019.
Catalyst management will host an investment-community conference call and webcast at 8:30 a.m. ET, tomorrow, Tuesday, August 11, 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
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
now commercially available in the United States. Prior to its approval, Firdapse for LEMS had received breakthrough therapy designation and orphan drug designation from the FDA.
Firdapse is 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 and CMS. Firdapse (amifampridine) 10 mg tablets
is the first and only approved drug in Europe for the symptomatic treatment in adults with LEMS.
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 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 be successful; (v) whether Firdapse will ever be approved for
commercialization for the treatment of MuSK-MG, SMA Type 3, or any other disease; (vi) whether Catalyst can successfully commercialize Firdapse in
Canada; (vii) whether Catalyst is able to successfully complete the clinical trial required for Catalyst to seek approval to commercialize Firdapse for sale in Japan; (viii) whether
Catalyst will ever be approved for commercialization in Japan; and (ix) 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 June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Product revenue, net | $ | 29,604,764 | $ | 28,837,900 | $ | 58,741,236 | $ | 41,286,338 | ||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of sales | 4,139,873 | 4,261,625 | 8,290,739 | 5,973,413 | ||||||||||||
| Research and development | 4,349,643 | 4,629,364 | 8,572,454 | 7,937,323 | ||||||||||||
| Selling, general and administrative | 10,833,358 | 8,987,722 | 20,896,406 | 17,404,182 | ||||||||||||
| Total operating costs and expenses | 19,322,874 | 17,878,711 | 37,759,599 | 31,314,918 | ||||||||||||
| Operating income (loss) | 10,281,890 | 10,959,189 | 20,981,637 | 9,971,420 | ||||||||||||
| Other income, net | 111,269 | 450,410 | 447,502 | 793,676 | ||||||||||||
| Net income (loss) before income taxes | 10,393,159 | 11,409,599 | 21,429,139 | 10,765,096 | ||||||||||||
| Provision for income taxes | 613,172 | 449,651 | 1,223,137 | 449,651 | ||||||||||||
| Net income (loss) | $ | 9,779,987 | $ | 10,959,948 | $ | 20,206,002 | $ | 10,315,445 | ||||||||
| Net income (loss) per share: | ||||||||||||||||
| Basic | $ | 0.09 | $ | 0.11 | $ | 0.20 | $ | 0.10 | ||||||||
| Diluted | $ | 0.09 | $ | 0.10 | $ | 0.19 | $ | 0.10 | ||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 103,414,523 | 102,869,202 | 103,410,881 | 102,808,897 | ||||||||||||
| Diluted | 106,730,423 | 105,928,970 | 106,433,862 | 105,098,930 |
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2020 | December 31, 2019 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 115,052,248 | $ | 89,511,710 | ||||
| Short-term investments | 5,007,050 | |||||||
| Accounts receivable, net | 6,762,262 | 10,536,997 | ||||||
| Inventory | 1,827,924 | 1,956,792 | ||||||
| Prepaid expenses and other current assets | 7,521,253 | 4,351,074 | ||||||
| Total current assets | 131,163,687 | 111,363,623 | ||||||
| Operating lease right-of-use asset | 71,711 | 793,252 | ||||||
| Property and equipment, net | 167,514 | 210,467 | ||||||
| Deposits | 8,888 | 8,888 | ||||||
| Total assets | $ | 131,411,800 | $ | 112,376,230 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 5,804,778 | $ | 4,117,447 | ||||
| Accrued expenses and other liabilities | 14,405,597 | 19,981,295 | ||||||
| Total current liabilities | 20,210,375 | 24,098,742 | ||||||
| Operating lease liability, net of current portion | 647,532 | |||||||
| Total liabilities | 20,210,375 | 24,746,274 | ||||||
| Total stockholders equity | 111,201,425 | 87,629,956 | ||||||
| Total liabilities and stockholders equity | $ | 131,411,800 | $ | 112,376,230 |