Catalyst Pharmaceuticals Announces First Quarter 2020 Financial Results and Provides Corporate Update
- Firdapse® Q1 2020 Net Revenues of
- First Quarter 2020 GAAP Net Income of
- Catalyst Withdraws Previous 2020 Revenue Guidance Due to COVID-19 Uncertainties
- Catalyst to Host Quarterly Conference Call at
8:30 AM ET Tomorrow
“I am very proud of the way that the entire Catalyst team has quickly responded and adapted in these challenging and unprecedented times to ensure the safety of all employees, while still providing uninterrupted access to Firdapse® for LEMS patients and continuing our support with their healthcare providers, albeit remotely” said
Q1-20 Financial Results
- Reported net product revenue of
$29.1 millionin the first quarter 2020 compared to $12.4 millionin the first quarter of 2019, an increase of $16.7 million, or 134%.
- Reported GAAP net income of
$10.4 million, or $0.10per basic and diluted share, for the first quarter of 2020, compared with a GAAP net loss of $645 thousand, or $0.01per basic and diluted share, for the first quarter of 2019.
- Research and development expenses for the first quarter of 2020 were
$4.2 millionas compared to $3.3 millionfor the first quarter of 2019.
- Selling, general and administrative expenses for the first quarter of 2020 totaled
$10.1 millionas compared to $8.4 millionin the first quarter of 2019.
March 31, 2020with $101.8 millionin cash and investments and no funded debt.
Recent Developments and Highlights
- In the first quarter nearly doubled the size of our field sales force and contracted with a rare-disease experienced inside sales agency to support our commercial efforts.
- Increased our marketing efforts in non-personal promotion and digital communications.
- 46 new LEMS patients were prescribed Firdapse in first quarter of 2020.
Financial Highlights and Guidance
- Withdrawing previously provided 2020 revenue guidance due to the uncertainties surrounding COVID-19 disruptions to the healthcare system.
- Strong balance sheet with
$101.8 millionin cash and investments, and no funded debt.
- Focused on exercising financial discipline.
- Expect to report top-line results from Phase 3 trial for MuSK-MG in the third quarter of 2020.
- Expect to report top-line results from the SMA Type 3 proof of concept trial before the end of 2020.
- Expect potential approval of New Drug Submission (NDS) for Firdapse to treat LEMS in
Canadain the second half of 2020.
- Expect to submit a supplemental NDA for Firdapse for MuSK-MG, assuming successful completion of the MSK-002 trial, later this year or early next year.
- Issued a no travel and remote work policy for all Catalyst employees on
- Our first quarter revenues were minimally impacted by COVID-19.
- We believe that our current base of LEMS patients on reimbursed Firdapse is fairly stable and very compliant to their medication regimen.
- Top-line data for MuSK-MG trial has moved to third quarter as a result of clinical trial sites temporarily suspending trial activities.
- Have not experienced any disruptions in the supply chain or production of Firdapse.
- Completed manufacturing campaigns to provide Firdapse inventory through
June 2021, with new campaigns underway.
- 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.
For the quarter ended
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
Catalyst launched its first product, Firdapse, in
Research and development expenses for the first quarter of 2020 were
Selling, general and administrative expenses for the first quarter of 2020 totaled
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 May 11, 2020.
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 MuSK-MG trial and SMA Type 3 proof-of-concept study, and (ii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2019 and Catalyst's other filings with the
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
For the Three Months Ended
|Product revenue, net||$||29,136,472||$||12,448,438|
|Operating costs and expenses:|
|Cost of sales||4,150,866||1,711,788|
|Research and development||4,222,811||3,307,959|
|Selling, general and administrative||10,063,048||8,416,460|
|Total operating costs and expenses||18,436,725||13,436,207|
|Operating income (loss)||10,699,747||(987,769||)|
|Other income, net||336,233||343,266|
|Net income (loss) before income taxes||11,035,980||(644,503||)|
|Provision for income taxes||609,965||--|
|Net income (loss)||$||10,426,015||$||(644,503||)|
|Net income (loss) per share – basic and diluted||$||0.10||$||(0.01||)|
|Weighted average shares outstanding – basic||103,407,347||102,747,923|
|Weighted average shares outstanding – diluted||106,534,600||102,747,923|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||101,750,937||$||89,511,710|
|Accounts receivable, net||6,918,563||10,536,997|
|Prepaid expenses and other current assets||6,062,715||4,351,074|
|Total current assets||116,943,553||111,363,623|
|Operating lease right-of-use asset||730,284||793,252|
|Property and equipment, net||196,926||210,467|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||16,287,936||19,981,295|
|Total current liabilities||17,635,513||24,098,742|
|Operating lease liability, net of current portion||568,421||647,532|
|Total stockholders’ equity||99,675,717||87,629,956|
|Total liabilities and stockholders’ equity||$||117,879,651||$||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.