Catalyst Pharmaceuticals Announces Second Quarter 2019 Financial Results and Provides Corporate Update
Firdapse® Launch Momentum Continues with Second Quarter Net Revenues of
409 Adult LEMS Patients Active on Firdapse as of
Company to Host Quarterly Conference Call at
“We are very pleased with the continued strength of the commercial launch of Firdapse®, the first and only evidence-based,
Q2-19 Financial Results
- Product revenue, net in the second quarter 2019 was
- Reported net income of
$11.0 million, or $0.11per basic and $0.10per diluted share, in the second quarter of 2019, compared with a net loss of $6.0 million, or $0.06per basic and diluted share, for the second quarter of 2018.
- Selling, general and administrative expenses for the second quarter of 2019 totaled
$9.0 millionas compared to $2.6 millionin the second quarter of 2018.
- Research and development expenses for the second quarter of 2019 were
$4.6 millionas compared to $3.7 millionfor the second quarter of 2018.
June 30, 2019with $64.9 millionin cash and investments and no funded debt.
Recent Developments and Highlights
- Initiated commercial launch of Firdapse for LEMS on
January 15, 2019.
- Had 409 adult LEMS patients on Firdapse as of
June 30, 2019, compared to 337 patients on March 31, 2019.
- As of today, 138 patients previously naïve to any form of 3,4-DAP are enrolled in Catalyst Pathways.
- Amended our Firdapse license agreement to expand the commercial territory to include
- Global expansion of Firdapse for LEMS underway in
- Filed federal lawsuit against
U.S. Food and Drug Administrationchallenging the approval of RuzurgiTM for the treatment of pediatric LEMS patients (ages 6 to under 17).
- Expect to complete enrollment for the MuSK-MG trial in the second half of 2019 and to report top-line results from this trial in the first half of 2020.
- Expect top-line results from Phase 3 trial for CMS in the second half of 2019.
- Expect top-line results for SMA Type 3 proof of concept trial in the first half of 2020.
For the quarter ended
Research and development expenses for the second quarter of 2019 were
Selling, general and administrative expenses for the second quarter of 2019 totaled
Catalyst launched its first product, Firdapse, in
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 (
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, CMS, 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) whether, even if Catalyst is successful in commercializing Firdapse, Catalyst will achieve sustained profitability, (ii) the effect on Catalyst’s business and future results of operations of the recent approval by the
CATALYST PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
|For the Three Months
Ended June 30,
|For the Six Months
Ended June 30,
|Product revenue, net||$||28,837,900||$||--||$||41,286,338||$||--|
|Operating costs and expenses:|
|Cost of sales||4,261,625||--||5,973,413||--|
|Research and development||4,629,364||3,704,824||7,937,323||6,963,866|
|Selling, general and administrative||8,987,722||2,631,031||17,404,182||5,305,429|
|Total operating costs and expenses||17,878,711||6,335,855||31,314,918||12,269,295|
|Operating income (loss)||10,959,189||(6,335,855||)||9,971,420||(12,269,295||)|
|Other income, net||450,410||370,715||793,676||604,263|
|Net income (loss) before income taxes||11,409,599||(5,965,140||)||10,765,096||(11,665,032||)|
|Provision for income taxes||449,651||--||449,651||--|
|Net income (loss)||$||10,959,948||$||(5,965,140||)||$||10,315,445||$||(11,665,032||)|
|Net income (loss) per share:|
|Weighted average shares outstanding:|
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||23,417,512||$||16,559,400|
|Accounts receivable, net||10,376,427||--|
|Prepaid expenses and other current assets||1,488,603||1,649,781|
|Total current assets||72,055,863||55,187,406|
|Operating lease right-of-use asset||1,013,590||--|
|Property and equipment, net||147,619||245,425|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||10,822,803||7,173,987|
|Total current liabilities||14,151,529||9,511,354|
|Accrued expenses and other liabilities, non-current||--||154,799|
|Operating lease liability, net of current portion||801,264||--|
|Total stockholders’ equity||63,281,567||50,783,809|
|Total liabilities and stockholders’ equity||$||78,234,360||$||60,449,962|
Brian KorbSolebury Trout (646) 378-2923 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com Media Contact David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.