Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a
commercial-stage biopharmaceutical company focused on developing
and commercializing innovative therapies for people with rare
debilitating, chronic neuromuscular and neurological diseases,
today provided an update on certain impacts of COVID-19 on its
business operations.
“We are committed to protecting the safety and
well-being of our personnel, the entire LEMS community, healthcare
providers, patients in clinical trials, and clinical trial site
employees, and this will remain our priority throughout these
challenging times,” said Patrick J. McEnany, Chairman and Chief
Executive Officer of Catalyst Pharmaceuticals. Mr. McEnany
continued, “Additionally, well before the COVID-19 pandemic, we had
worked diligently to establish our supply chain to ensure that LEMS
patients would have access to Firdapse® without interruption, no
matter the circumstances.”
Protecting Catalyst Team and
Communities
On March 16th, Catalyst implemented a number of
safety related initiatives among its employees, including a travel
ban and a work from home policy for all employees. This included
Catalyst’s customer-facing employees, who are working remotely and
utilizing telephone and web-based technologies to provide support
to patients and their healthcare providers.
Catalyst is following the guidance from the U.S.
Centers for Disease Control and Prevention (CDC) and will continue
to assess when it is appropriate for our team to return to normal
work practices.
Corporate Partnership with First
Responders Children’s Foundation to Support COVID-19 Emergency
Response Fund
Catalyst announced today a corporate partnership
with First Responders Children’s Foundation to support the COVID-19
Emergency Response Fund. The Foundation has established this fund
to provide emergency grants to first responder families enduring
financial hardship due to the COVID-19 pandemic. For the past 20
years, First Responders Children's Foundation has been providing
college scholarships to children of first responders who have lost
a parent in the line of duty.
"First Responders Children's Foundation would
like to thank Catalyst for supporting the Foundation and for the
company's contribution to the COVID-19 Emergency Response Fund,"
said Jillian Crane, President of First Responders Children's
Foundation. "The support of Catalyst has allowed the Foundation to
provide much needed financial assistance to first responders on the
front lines during these challenging times."
Firdapse Manufacturing and
Supply
Our Firdapse supply chain remains robust and
ready for any contingencies that arise due to the COVID-19
outbreak, and thus far we have observed no disruptions in the
production of Firdapse. We reiterate that we are committed to
providing patients with the ability to obtain an uninterrupted
supply of Firdapse. As we reported on our fourth quarter and year
end conference call a few weeks ago, we have an adequate supply of
Firdapse to address patients’ needs through December and are
pleased to report that we have just completed a manufacturing
campaign that will provide an additional six months of inventory
beyond December. Like Catalyst, our U.S. manufacturing partners
have implemented contingency plans to remain in operation, and we
are confident in their ability to continue to produce domestically
our active ingredient and finished Firdapse product. We are
committed to meeting our patients needs for Firdapse and believe
that our supply chain will remain solid and uninterrupted through
the current COVID-19 outbreak and beyond.
Financial Outlook
On our March 16th fourth quarter and year end
conference call, we reported full-year 2019 net revenues of $102
million and reiterated our net revenue guidance in the range of
$135 to $155 million for full-year 2020. We continue to assess the
potential impact that COVID-19 could have on our revenue and expect
to provide an update during our first quarter 2020 results call
next month. Thus far the impact that we have seen has been minimal,
but we will continue to evaluate our yearly guidance based on this
dynamic environment.
Catalyst ended 2019 in a strong financial
position. The Company reported that it had $94.5 million of cash
and investments as of December 31, 2019 and that it had increased
its cash and investments by approximately $36 million during full
year 2019. Also, as of today, Catalyst continues to have no
funded debt.
Clinical Development
Timelines
At this time, we continue to believe that we
will report top-line results from our Phase 3 trial for MuSK-MG in
the current quarter, but the worldwide travel restrictions and
social distancing requirements of the COVID-19 pandemic have put a
strain on clinical trial staff and their availability for study
close-out activities. Catalyst is continuing to monitor sites
through remote means in accordance with guidance recently provided
by the FDA and is working with sites remotely on data entry and
data checking, to the extent that sites will allow and study
coordinators are able. Catalyst is fortunate that enrollment had
been completed, and the trial was nearly finished, before the
advent of the COVID-19 health emergency. However, many
activities at trial sites need to occur before our study can be
unblinded. Assuming this trial is successful, we hope to submit an
sNDA for Firdapse for MuSK-MG by the end of this year. We expect
that we will be able to provide more current information on our
clinical programs during our first quarter earnings call that is
scheduled for next month.
In addition, we had planned to report top-line
results from our SMA Type 3 proof-of-concept trial in the current
quarter. However, the Serbian government has recently imposed
temporary new regulations for clinical trials requiring all
clinical activities not needed for patient safety to be
halted. Although fully recruited, screened, and ready to
start, our SMA trial subjects in Serbia were not yet initiated when
the pandemic began, and, due to this recent decision by the Serbian
government, they are not permitted to start. In light of
these regulations, we now know that it will not be possible for us
to report top-line results from this trial before the end of this
quarter.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for people with rare debilitating, chronic
neuromuscular and neurological diseases, including Lambert-Eaton
myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia
gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3.
Catalyst's new drug application for Firdapse® (amifampridine) 10 mg
tablets for the treatment of adults with LEMS was approved in
November 2018 by the U.S. Food & Drug
Administration ("FDA"), and Firdapse is now commercially
available in the United States. Prior to its approval,
Firdapse for LEMS had received breakthrough therapy designation and
orphan drug designation from the FDA.
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.
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
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 U.S.
Securities and Exchange Commission (SEC), could adversely
affect Catalyst. Copies of Catalyst's filings with
the SEC are available from the SEC, may be found on
Catalyst's website, or may be obtained upon request from Catalyst.
Catalyst does not undertake any obligation to update the
information contained herein, which speaks only as of this
date.
Investor Contact
Brian Korb
Solebury Trout
(646) 378-2923
bkorb@troutgroup.com
Company Contact
Patrick J. McEnany
Catalyst Pharmaceuticals
Chief Executive Officer
(305) 420-3200
pmcenany@catalystpharma.com
Media Contact
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
Catalyst Pharmaceuticals (NASDAQ:CPRX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Catalyst Pharmaceuticals (NASDAQ:CPRX)
Historical Stock Chart
From Apr 2023 to Apr 2024