Catalyst Pharmaceuticals Announces Third Quarter 2020 Financial Results and Provides Business Update
- Firdapse® Third Quarter Net Revenues of $29.2 Million
- Company Ends Third Quarter with
- Firdapse® Approved in
- Company to Host Quarterly Conference Call at 8:30 am ET Tomorrow
“I am pleased to report on a very productive third quarter and on our continued commercial execution under challenging conditions and remain confident that we will continue to see more success as physicians and other providers adapt to this virtual working environment. Also, we are very encouraged by the number of new LEMS patient starts that were initiated over the past 2 months and are hopeful that this is the beginning of a trend,” said
Q3-20 Financial Results
- Product revenue, net in the third quarter of 2020 was
$29.2 million, compared to $30.9 millionfor the third quarter of 2019.
- Operating income for the third quarter of 2020 was
$11.7 million, compared to $13.8 millionin the third quarter of 2019.
- Reported net income of
$43.3 million, or $0.42per basic and $0.41per diluted share, in the third quarter of 2020, compared with net income of $13.6 million, or $0.13per basic and diluted share, for the third quarter of 2019.
- Net income in the third quarter of 2020 includes
$31.3 million( $0.30per basic and $0.29per diluted share) of benefit from recording of deferred tax asset, upon reversal of valuation allowance.
- Research and development expenses for the third quarter of 2020 were
$3.7 millionas compared to $4.6 millionfor the third quarter of 2019.
- Selling, general and administrative expenses for the third quarter of 2020 totaled
$10.0 millionas compared to $8.1 millionin the third quarter of 2019.
Corporate Highlights and Milestones
U.S.Patent for Firdapse® for "Methods of Administering 3,4-Diaminopyridine" issued.
- District Court’s ruling against us in our lawsuit versus the FDA.
- Appeal to the 11th
Circuit Court of Appealshas been made in lawsuit versus FDA and court has granted request for an expedited hearing.
- Executed license agreement with
KYE Pharmaceuticalsto make Firdapse® available to LEMS patients in Canada.
- Launched legal challenge to Health Canada’s decision to overlook Firdapse® data exclusivity.
- Actively engaged in evaluation of potential acquisition of products or companies.
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.
- Continuing the evaluation of the data from the MuSK-MG trial to determine the future of the program.
- Firdapse® long-acting formulation development program continues on schedule.
- Proof-of-concept studies for other additional neuromuscular indications are expected to commence in the near future.
- Issued a no travel and remote work policy for all Catalyst employees on
- Diligently working to reduce COVID-19 impact on new patient starts, enrollments and revenues.
- We believe that our current base of LEMS patients on reimbursed Firdapse® remains 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 currently 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 and 2021:
- 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
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 currently 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.
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 positive cash flow and 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 September 30,
|For the Nine Months
Ended September 30,
|Product revenue, net||$||29,166,658||$||30,897,444||$||87,907,894||$||72,183,782|
|Revenues from collaborative arrangements||150,000||--||150,000||--|
|Operating costs and expenses:|
|Cost of sales||3,878,760||4,387,461||12,169,499||10,360,874|
|Research and development||3,749,233||4,597,039||12,321,687||12,534,362|
|Selling, general and administrative||9,984,961||8,067,792||30,881,367||25,471,974|
|Total operating costs and expenses||17,612,954||17,052,292||55,372,553||48,367,210|
|Operating income (loss)||11,703,704||13,845,152||32,685,341||23,816,572|
|Other income, net||33,567||393,415||481,069||1,187,091|
|Net income (loss) before income taxes||11,737,271||14,238,567||33,166,410||25,003,663|
|Income tax provision (benefit)||(31,602,596||)||608,388||(30,379,459||)||1,058,039|
|Net income (loss)||$||43,339,867||$||13,630,179||$||63,545,869||$||23,945,624|
|Net income (loss) per share:|
|Weighted average shares outstanding:|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||117,105,973||$||89,511,710|
|Accounts receivable, net||5,871,893||10,536,997|
|Prepaid expenses and other current assets||5,614,052||4,351,074|
|Total current assets||143,342,205||111,363,623|
|Deferred tax assets||31,347,442||--|
|Operating lease right-of-use asset||12,167||793,252|
|Property and equipment, net||149,119||210,467|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||16,226,609||19,981,295|
|Total current liabilities||18,231,949||24,098,742|
|Operating lease liability, net of current portion||--||647,532|
|Total stockholders’ equity||156,627,872||87,629,956|
|Total liabilities and stockholders’ equity||$||174,859,821||$||112,376,230|
Brian KorbSolebury Trout (646) 378-2923 email@example.com Media Contact David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com
Source: Catalyst Pharmaceuticals, Inc.