Catalyst Pharmaceuticals Announces Second Quarter 2020 Financial Results and Provides Business Update
- Firdapse® Second Quarter Net Revenues of
- Health Canada Approves Marketing Authorization for Firdapse® for Treating LEMS Patients
- MuSK-MG Phase 3 Trial did not Achieve Statistical Significance for Primary or Secondary Endpoints
- Company to Host Quarterly Conference Call at
“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
Q2-20 Financial Results
- Product revenue, net in the second quarter 2020 was
$29.6 million compared to$28.8 for the second quarter 2019. - Reported net income of
$9.8 million , or$0.09 per basic and diluted share, in the second quarter of 2020, compared with net income of$11.0 million , or$0.11 per basic and$0.10 per diluted share, for the second quarter of 2019. - Research and development expenses for the second quarter of 2020 were
$4.3 million as compared to$4.6 million for the second quarter of 2019. - Selling, general and administrative expenses for the second quarter of 2020 totaled
$10.8 million as compared to$9.0 million in the second quarter of 2019. - The Company’s total operating expenses for the second quarter 2020 were
$19.3 million . - Ended
June 30, 2020 with$115.1 million in cash and investments and no funded debt.
Corporate Highlights and Milestones
- Announced receipt of marketing authorization from
Health Canada for Firdapse® for the treatment of patients inCanada with LEMS. - Announced
Jeffrey Del Carmen promotion to Chief Commercial Officer. - Recently met with the Japanese PMDA and believe we have reached a tentative agreement for an acceptable and efficient regulatory plan.
- Continued on-going evaluation of potential acquisition of products or companies.
MuSK-MG Phase 3 Study Results
- Firdapse® was safe and well tolerated during the MSK-002 study and demonstrated a safety profile similar to that seen for Firdapse® in the treatment of LEMS.
- The primary endpoint, the Myasthenia Gravis Activities of Daily Living (MG-ADL) assessment, did not achieve statistical significance (p=0.2196).
- The secondary endpoint, the Quantitative Myasthenia Gravis (QMG) assessment, did not achieve statistical significance (p=0.3736).
- We plan to complete the full analysis of data and findings and to meet with our neuromuscular advisors to decide our path forward for the MuSK-MG indication.
- Detailed results of this study will be made available in a future scientific forum.
Other Firdapse® Development Programs
- Enrollment in proof-of-concept spinal muscular atrophy type-3 study has been completed and we expect to report top-line data before year-end.
- Firdapse® long-acting formulation development program continues on schedule.
- Investigator studies for two additional neuromuscular indications are expected to commence later this year.
COVID-19 Impact
- Issued a no travel and remote work policy for all Catalyst employees on
March 16th . - Diligently working to reduce COVID-19 impact on new enrollments and revenues.
- We believe that our current base of LEMS patients on reimbursed Firdapse® is 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 2020
At
The Company plans to continue investing in the following key activities in 2020:
- Expansion of
U.S. commercialization of Firdapse®. - On-going development programs evaluating Firdapse® for the treatment of MuSK-MG and SMA Type 3, and our Expanded Access Program for Firdapse®.
- Continue support for our Firdapse® long acting formulation and other development programs.
- Support
Canada pre-commercialization activities for Firdapse®. - Continue
Japan regulatory activities to seek marketing authorization for Firdapse®.
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
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 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
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 Six Months Ended |
|||||||||||
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 | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS
2020 |
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 |
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.