Full Press Release Details
Catalyst Pharmaceuticals Reports Third Quarter 2021 Financial Results
Continued Strong Financial and Operational Performance in the Third Quarter 2021
FIRDAPSE Revenue of $35.9 Million Increased 23.1% Compared to Third Quarter
Plans to Seek to Expand the U.S. Approval of FIRDAPSE To Include Pediatric LEMS Patients
Strong Cash Position $174.8 Million Supports Long-term Growth Strategy
Company to Host Quarterly Conference Call on November 10, 2021, at 8:30 AM ET
CORAL GABLES, Fla., November 9, 2021 Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a
commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported
financial results for the third quarter ended September 30, 2021, and provided a corporate update.
We delivered another quarter of strong
financial results while making important progress on all fronts, said Patrick J. McEnany, Chairman and CEO of Catalyst. We reported a record quarter for net sales for FIRDAPSE ,
further underscoring the strength of our commercial capabilities while advancing our efforts in support of the orphan drug exclusivity of FIRDAPSE for the treatment of LEMS. We continued to execute on all key growth initiatives, including plans to
expand the label for FIRDAPSE to include all LEMS patients, including the very few pediatric patients diagnosed with LEMS. Our quarterly achievements demonstrate continued performance excellence supported by several key strategic decisions that have
positioned Catalyst firmly for the future. In saying that, we are excited about the path ahead as we continue to execute across all fronts to drive sustainable growth for the long term.
Operational Highlights
Third Quarter 2021 Financial Results
Non-GAAP Financial Measures
Non-GAAP1 net income for
Q3-21 was $15.6 million ($0.15 per basic and $0.14 per diluted share), which excludes from GAAP net income of $10.3 million (i) stock-based compensation expense of $1.5 million,
(ii) depreciation of $31 thousand, and (iii) the provision for income taxes of $3.7 million. This compares to non-GAAP1 net income for Q3-20 of $13.2 million ($0.13 per basic and $0.12 per diluted share), which excludes from GAAP net income of $43.3 million (i) stock-based compensation expense of $1.5 million,
(ii) depreciation of $30 thousand, and (iii) a benefit for income taxes of $31.6 million, as the Company recorded the deferred tax asset during Q3-20. A tabular presentation of non-GAAP1 net income for the three months and nine months ended September 30, 2021 and 2020 is included below.
The non-GAAP financial measures in this press release exclude from the calculation of net income (i) the expense
associated with non-cash stock-based compensation, (ii) depreciation expense, and (iii) the (benefit) provision for income taxes. Non-GAAP income per share is
calculated by dividing non-GAAP income by the weighted average common shares outstanding.
More detailed financial
information and analysis can 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, 2021.
Catalyst management will host a
conference call and webcast on Wednesday, November 10, 2021, at 8:30 AM ET to discuss the financial results and provide a corporate update.
To access the call, please dial 877-407-8912 for the United States and Canada
or 201-689-8059 for International. A webcast of the call will be available on the Investors section of the Company s website at www.catalystpharma.com.
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, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare
diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for rare diseases.
Catalyst s New Drug Application for FIRDAPSE (amifampridine) Tablets 10 mg for the treatment of adults with LEMS was approved in 2018 by the U.S. Food & Drug
Administration ( FDA ), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. Further, Canada s national healthcare regulatory agency, Health Canada, approved the use
of FIRDAPSE (amifampridine) for the treatment of adult patients in Canada 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 continuing effect of the COVID-19 pandemic on Catalyst s net
product revenues and net income, (ii) Catalyst s ability to locate and acquire new product candidates through acquisition or in-licensing, (iii) Catalyst s ability to successfully develop
any new product candidates acquired or in-licensed, (iv) Catalyst s ability to successfully develop and commercialize a long-acting formulation of FIRDAPSE, and (v) those factors described in
Catalyst s Annual Report on Form 10-K for the fiscal year 2020 and Catalyst s 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)
(in thousands, except share data)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Product revenue, net | $ | 35,890 | $ | 29,167 | $ | 99,731 | $ | 87,908 | ||||||||
| License and other revenue | 64 | 150 | 2,793 | 150 | ||||||||||||
| Total revenues | 35,954 | 29,317 | 102,524 | 88,058 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of sales | 5,310 | 3,879 | 14,536 | 12,170 | ||||||||||||
| Research and development | 4,487 | 3,749 | 11,944 | 12,322 | ||||||||||||
| Selling, general and administrative | 12,153 | 9,985 | 36,401 | 30,881 | ||||||||||||
| Total operating costs and expenses | 21,950 | 17,613 | 62,881 | 55,373 | ||||||||||||
| Operating income | 14,004 | 11,704 | 39,643 | 32,685 | ||||||||||||
| Other income, net | 68 | 33 | 211 | 481 | ||||||||||||
| Net income before income taxes | 14,072 | 11,737 | 39,854 | 33,166 | ||||||||||||
| Income tax provision (benefit) | 3,743 | (31,603 | ) | 9,681 | (30,380 | ) | ||||||||||
| Net income | $ | 10,329 | $ | 43,340 | $ | 30,173 | $ | 63,546 | ||||||||
| Net income per share: | ||||||||||||||||
| Basic | $ | 0.10 | $ | 0.42 | $ | 0.29 | $ | 0.61 | ||||||||
| Diluted | $ | 0.10 | $ | 0.41 | $ | 0.28 | $ | 0.60 | ||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 103,196,550 | 103,535,431 | 103,470,762 | 103,452,025 | ||||||||||||
| Diluted | 107,843,196 | 106,316,241 | 107,476,175 | 106,386,617 |
CATALYST PHARMACEUTICALS, INC.
RECONCILIATION OF NON-GAAP METRICS (unaudited)
(in thousands, except share data)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| GAAP net income | $ | 10,329 | $ | 43,340 | $ | 30,173 | $ | 63,546 | ||||||||
| Non-GAAP adjustments: | ||||||||||||||||
| Stock-based compensation expense | 1,512 | 1,478 | 4,601 | 4,792 | ||||||||||||
| Depreciation | 31 | 30 | 159 | 73 | ||||||||||||
| Income tax provision (benefit) | 3,743 | (31,603 | ) | 9,681 | (30,380 | ) | ||||||||||
| Non-GAAP net income | $ | 15,615 | $ | 13,245 | $ | 44,614 | $ | 38,031 | ||||||||
| Non-GAAP net income per share: | ||||||||||||||||
| Basic | $ | 0.15 | $ | 0.13 | $ | 0.43 | $ | 0.37 | ||||||||
| Diluted | $ | 0.14 | $ | 0.12 | $ | 0.42 | $ | 0.36 | ||||||||
| Weighted average shares outstanding basic | 103,196,550 | 103,535,431 | 103,470,762 | 103,452,025 | ||||||||||||
| Weighted average shares outstanding diluted | 107,843,196 | 106,316,241 | 107,476,175 | 106,386,617 |
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2021 | December 31, 2020 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 154,836 | $ | 130,237 | ||||
| Short-term investments | 19,956 | 10,041 | ||||||
| Accounts receivable, net | 6,625 | 5,987 | ||||||
| Inventory | 6,950 | 4,651 | ||||||
| Prepaid expenses and other current assets | 4,428 | 8,328 | ||||||
| Total current assets | 192,795 | 159,244 | ||||||
| Operating lease right-of-use asset | 3,093 | |||||||
| Property and equipment, net | 951 | 130 | ||||||
| Deferred tax assets | 26,400 | 32,971 | ||||||
| Deposits | 9 | 9 | ||||||
| Total assets | $ | 223,248 | $ | 192,354 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,752 | $ | 4,256 | ||||
| Accrued expenses and other liabilities | 17,862 | 18,500 | ||||||
| Total current liabilities | 20,614 | 22,756 | ||||||
| Operating lease liability, net of current portion | 3,973 | |||||||
| Total liabilities | 24,587 | 22,756 | ||||||
| Total stockholders equity | 198,661 | 169,598 | ||||||
| Total liabilities and stockholders equity | $ | 223,248 | $ | 192,354 |