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 millioncompared to $28.8for the second quarter 2019.
- Reported net income of
$9.8 million, or $0.09per basic and diluted share, in the second quarter of 2020, compared with net income of $11.0 million, or $0.11per basic and $0.10per diluted share, for the second quarter of 2019.
- Research and development expenses for the second quarter of 2020 were
$4.3 millionas compared to $4.6 millionfor the second quarter of 2019.
- Selling, general and administrative expenses for the second quarter of 2020 totaled
$10.8 millionas compared to $9.0 millionin the second quarter of 2019.
- The Company’s total operating expenses for the second quarter 2020 were
June 30, 2020with $115.1 millionin cash and investments and no funded debt.
Corporate Highlights and Milestones
- Announced receipt of marketing authorization from
Health Canadafor Firdapse® for the treatment of patients in Canadawith LEMS.
Jeffrey Del Carmenpromotion 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.
- Issued a no travel and remote work policy for all Catalyst employees on
- 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
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.
Canadapre-commercialization activities for Firdapse®.
Japanregulatory 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
Catalyst management will host an investment-community conference call and webcast at
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.
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
|For the Six Months
|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||$||10,315,445|
|Net income (loss) per share:|
|Weighted average shares outstanding:|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||115,052,248||$||89,511,710|
|Accounts receivable, net||6,762,262||10,536,997|
|Prepaid expenses and other current assets||7,521,253||4,351,074|
|Total current assets||131,163,687||111,363,623|
|Operating lease right-of-use asset||71,711||793,252|
|Property and equipment, net||167,514||210,467|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||14,405,597||19,981,295|
|Total current liabilities||20,210,375||24,098,742|
|Operating lease liability, net of current portion||--||647,532|
|Total stockholders’ equity||111,201,425||87,629,956|
|Total liabilities and stockholders’ equity||$||131,411,800||$||112,376,230|
Brian KorbSolebury Trout (646) 378-2923 email@example.com Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 firstname.lastname@example.org Media Contact David Schull Russo Partners(212) 845-4271 email@example.com
Source: Catalyst Pharmaceuticals, Inc.