Catalyst Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Corporate Update
- Firdapse® Launch Momentum Continues with Q3 Net Revenues of
-Third Quarter GAAP Net Income of
-Catalyst Provides Net Revenue Guidance – Approximately
-Company to Host Quarterly Conference Call at
“We are pleased with the continued strength of our commercial launch for Firdapse® in adult LEMS patients and are very encouraged by the feedback we have received from LEMS patients, including high levels of satisfaction regarding their treatment journey through Catalyst Pathways™, our patient assistance program,” said
Q3-19 Financial Results
- Reported product revenue, net in the third quarter 2019 of
$30.9 million - Reported net income of
$13.6 million , or$0.13 per basic and diluted share, in the third quarter of 2019, compared with a net loss of$7.8 million , or$0.08 per basic and diluted share, for the third quarter of 2018 - Selling, general and administrative expenses for the third quarter of 2019 totaled
$8.1 million as compared to$3.6 million in the third quarter of 2018 - Research and development expenses for the third quarter of 2019 were
$4.6 million as compared to$4.5 million for the third quarter of 2018 - Ended
September 30, 2019 with$81.6 million in cash and investments and no funded debt
Recent Developments and Highlights
- Reported a total of 494 cumulative Firdapse unique patient enrollments at the end of the third quarter since commercial launch at beginning of year
- Reported that over 170 patients previously naïve to any form of 3,4-DAP were enrolled in Catalyst Pathways at the end of the third quarter
- Over 370 patients actively receiving an insurance-reimbursed Firdapse prescription at the end of the third quarter
- Announced top-line results from CMS-001 Phase 3 trial of Firdapse for CMS
- Continued with global expansion efforts of Firdapse for LEMS with recent meetings with Japanese regulatory authorities to discuss regulatory path forward in
Japan - Recently filed New Drug Submission (NDS) with
Health Canada for Firdapse to treat LEMS and have been granted a Priority Review
Revenue Guidance
- The Company expects full-year 2019 net revenues to be approximately
$100 million - The Company expects full-year 2020 net revenues to be in the range of
$135 million to $155 million - Both the 2019 and the 2020 net revenue forecast assume only sales of Firdapse for the treatment of adult LEMS patients
Upcoming Milestones
- Expect to meet with the
FDA before year-end to discuss CMS-001 study outcome and path forward - Expect to report top-line results from Phase 3 trial for MuSK-MG in the first half of 2020
- Expect to report top-line results from the SMA Type 3 proof of concept trial in the first half of 2020
Financial Results
For the quarter ended
Catalyst launched its first product, Firdapse, in
Research and development expenses for the third quarter of 2019 were
Selling, general and administrative expenses for the third quarter of 2019 totaled
At
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 (
Conference Call
Catalyst management will host an investment-community conference call and webcast at
About
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 CMS and myasthenia gravis. 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) whether the Company's forecast for net revenue in full year 2019 and full year 2020 will prove correct, (ii) whether Catalyst can successfully increase sales of Firdapse through expansion of its sales personnel from current levels, (iii) whether, even if Catalyst achieves its forecasted net revenue targets, it will remain profitable, (iv) whether Catalyst will be able to compete successfully for adult LEMS patients against off-label use of Ruzurgi® (which is priced lower than Firdapse), (v) whether payors will, in the future, require that patients try off-label Ruzurgi® first before such payors will approve Firdapse as a treatment for adult LEMS patients (vi) whether Catalyst’s NDS for Firdapse filed with
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
|||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||
Product revenue, net. | $ | 30,897,444 | $ | -- | $ | 72,183,782 | $ | -- | ||||||
Operating costs and expenses: | ||||||||||||||
Cost of sales | 4,387,461 | -- | 10,360,874 | -- | ||||||||||
Research and development | 4,597,039 | 4,538,369 | 12,534,362 | 11,502,235 | ||||||||||
Selling, general and administrative | 8,067,792 | 3,644,234 | 25,471,974 | 8,949,663 | ||||||||||
Total operating costs and expenses | 17,052,292 | 8,182,603 | 48,367,210 | 20,451,898 | ||||||||||
Operating income (loss) | 13,845,152 | (8,182,603 | ) | 23,816,572 | (20,451,898 | ) | ||||||||
Other income, net | 393,415 | 343,730 | 1,187,091 | 947,993 | ||||||||||
Net income (loss) before income taxes | 14,238,567 | (7,838,873 | ) | 25,003,663 | (19,503,905 | ) | ||||||||
Provision for income taxes | 608,388 | -- | 1,058,039 | -- | ||||||||||
Net income (loss) | $ | 13,630,179 | $ | (7,838,873 | ) | $ | 23,945,624 | $ | (19,503,905 | ) | ||||
Net income (loss) per share: | ||||||||||||||
Basic | $ | 0.13 | $ | (0.08 | ) | $ | 0.23 | $ | (0.19 | ) | ||||
Diluted | $ | 0.13 | $ | (0.08 | ) | $ | 0.23 | $ | (0.19 | ) | ||||
Weighted average shares outstanding: | ||||||||||||||
Basic | 102,974,105 | 102,641,504 | 102,864,571 | 102,598,740 | ||||||||||
Diluted | 107,045,234 | 102,641,504 | 105,821,609 | 102,598,740 |
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, 2019 |
December 31, 2018 |
||||
(unaudited) | |||||
ASSETS | |||||
Current Assets: | |||||
Cash and cash equivalents | $ | 44,983,218 | $ | 16,559,400 | |
Short-term investments | 31,561,673 | 36,922,213 | |||
Accounts receivable, net | 10,095,352 | -- | |||
Inventory | 599,801 | 56,012 | |||
Prepaid expenses and other current assets | 3,339,399 | 1,649,781 | |||
Total current assets | 90,579,443 | 55,187,406 | |||
Investments | 5,008,800 | 5,008,243 | |||
Operating lease right-of-use asset | 952,340 | -- | |||
Property and equipment, net | 141,088 | 245,425 | |||
Deposits | 8,888 | 8,888 | |||
Total assets | $ | 96,690,559 | $ | 60,449,962 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
Current Liabilities: | |||||
Accounts payable | $ | 4,147,029 | $ | 2,337,367 | |
Accrued expenses and other liabilities | 13,835,292 | 7,173,987 | |||
Total current liabilities | 17,982,321 | 9,511,354 | |||
Accrued expenses and other liabilities, non-current | -- | 154,799 | |||
Operating lease liability, net of current portion | 725,700 | -- | |||
Total liabilities | 18,708,021 | 9,666,153 | |||
Total stockholders’ equity | 77,982,538 | 50,783,809 | |||
Total liabilities and stockholders’ equity | $ | 96,690,559 | $ | 60,449,962 |
Investor ContactBrian Korb Solebury Trout (646) 378-2923 bkorb@troutgroup.com Media ContactDavid Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com Company ContactPatrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com
Source: Catalyst Pharmaceuticals, Inc.