Protalix BioTherapeutics Reports Third Quarter 2024 Financial and Business Results
PR Newswire
CARMIEL, Israel, Nov. 14, 2024
Company to host conference call and webcast today at 8:30 a.m. EST
CARMIEL, Israel, Nov. 14, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx$(R)$ plant cell-based protein expression system, today reported financial results for the quarter ended September 30, 2024, and provided a business and clinical update.
"We are pleased to report that all eight cohorts of our phase I first-in-human study of PRX-115, our recombinant uricase candidate being developed for the treatment of uncontrolled gout, are now complete," said Dror Bashan, Protalix's President and Chief Executive Officer. "Preliminary results from this study, being presented today and this week in a late-breaking poster at ACR Convergence 2024, are encouraging and demonstrate the potential of PRX-115 to be a promising uric-acid lowering treatment option for individuals with gout. We are actively planning a phase II clinical trial of PRX-115 in gout patients and expect to initiate the study in the second half of 2025."
Third Quarter 2024 and Recent Business Highlights
Pipeline Developments
The Company's PRX--115 trial is a double blind, placebo-controlled, single ascending dose (SAD), First-in-Human phase I clinical trial evaluating PRX--115 for the potential treatment of gout. The study is designed to evaluate the safety, pharmacokinetics $(PK)$ and pharmacodynamics (PD; reduction of uric acid) following a single dose of PRX-115 in subjects with elevated uric acid levels. In the study, 64 randomized subjects were enrolled across eight cohorts, each composed of eight subjects (six active and two placebo). All of the subjects completed the study. At this time, the data is locked and is currently being analyzed.
Preliminary results from the full study are as follows:
-- Exposure to PRX-115 increased in a dose-dependent manner. PRX-115 levels
were observed in plasma for up to 12 weeks from subjects in cohorts 6, 7
and 8.
-- In all tested doses, a single dose of PRX-115 rapidly reduced plasma uric
acid levels. The effect and duration of response were found to be dose
dependent. Following a single dose, mean plasma uric acid levels remained
below 6.0 mg/dL for up to 12 weeks at the highest dose levels.
-- PRX--115 was found to be well-tolerated with only 25% of the subjects
treated with PRX--115 in the study (12/48) having reported study
drug-related adverse events, the majority of which were mild to moderate
and transient in nature. One subject experienced an anaphylactic reaction
immediately following the start of infusion that was resolved completely.
No other serious adverse events were reported in the study.
The preliminary results demonstrate that PRX-115 may offer an effective uric acid-lowering treatment with an added benefit of a potentially wide dosing interval, which may enhance patient compliance and treatment flexibility. Further studies are needed to confirm the long-term safety and efficacy of PRX-115 in the gout patient population.
These preliminary results are being presented in a late-breaking poster at the American College of Rheumatology $(ACR)$ Convergence 2024, being held November 14-19, 2024 at the Walter E. Washington Convention Center in Washington, D.C. The accepted abstract can be accessed on the ACR Convergence 2024 website at https://acrabstracts.org/abstract/prolonged-plasma-urate-lowering-after-a-single-intravenous-administration-of-prx-115-a-novel-pegylated-uricase-in-participants-with-elevated-urate-levels/. A copy of the poster will be made available on the Protalix website.
Corporate Developments
-- In September 2024, the Company repaid in full all of the outstanding
principal and interest payable under its 7.50% Senior Secured Convertible
Promissory Notes due September 2024. The repayment of the convertible
notes at maturity was financed entirely with available cash.
Third Quarter 2024 Financial Highlights
-- The Company recorded revenues from selling goods of $17.8 million during
the three months ended September 30, 2024, an increase of $7.6 million,
or 75%, compared to revenues of $10.2 million for the three months ended
September 30, 2023. The increase resulted primarily from an increase of
$6.8 million in sales to Chiesi Farmaceutici S.p.A. ("Chiesi"), and an
increase of $1.1 million in sales to Pfizer Inc. ("Pfizer"), partially
offset by a decrease of $0.3 million in sales to Brazil.
-- The Company recorded revenues from license and R&D services of $0.1
million for the three months ended September 30, 2024, a decrease of $0.1
million, or 50%, compared to revenues of $0.2 million for the three
months ended September 30, 2023. Revenues from license and R&D services
are comprised primarily of revenues we recognized in connection with our
license agreements with Chiesi.
-- Cost of goods sold was $8.4 million for the three months ended September
30, 2024, an increase of $3.5 million, or 71%, from cost of goods sold of
$4.9 million for the three months ended September 30, 2023. The increase
in cost of goods sold was primarily the result of an increase in sales to
Chiesi and Pfizer.
-- For the three months ended September 30, 2024, our total research and
development expenses were approximately $3.0 million comprised of
approximately $0.6 million in subcontractor-related expenses,
approximately $1.6 million of salary and related expenses, approximately
$0.2 million of materials-related expenses and approximately $0.6 million
of other expenses. For the three months ended September 30, 2023, our
total research and development expenses were approximately $3.7 million
comprised of approximately $1.0 million of subcontractor-related expenses,
approximately $1.9 million of salary and related expenses, approximately
$0.2 million of materials-related expenses and approximately $0.6 million
of other expenses.Total decrease in research and developments expenses
for the three months ended September 30, 2024 was $0.7 million, or 19%,
compared to the three months ended September 30, 2023. The decrease in
research and development expenses resulted primarily from the completion
of our Fabry clinical program and the regulatory processes related to the
review of the Elfabrio Biologics License Application $(BLA.AU)$ in the United
States and the Marketing Authorization Application $(MAA)$ in the European
Union by the applicable regulatory agencies.
-- Selling, general and administrative expenses were $2.6 million for the
three months ended September 30, 2024, a decrease of $1.1 million, or 30%,
compared to $3.7 million for the three months ended September 30, 2023.
The decrease resulted primarily from a decrease of $0.5 million in salary
and related expenses and a decrease of $0.4 million in professional fees.
-- Financial expenses, net was $0.1 million for the three months ended
September 30, 2024, compared to financial income, net of $0.2 million for
the three months ended September 30, 2023. The difference resulted
primarily from lower interest income on bank deposits, higher exchange
rate costs partially offset by lower notes interest expenses due to the
September 2024 repayment in full of all the outstanding principal and
interest payable under the 2024 Notes.
-- For the three months ended September 30, 2024, we recorded income taxes
of approximately $0.6 million, compared to income taxes of $0.1 million
for the three months ended September 30, 2023. Income taxes recorded are
primarily the result of tax expenses in respect of Section 174 of the
U.S. Tax Cuts and Jobs Act, which was enacted in December 2017.
-- Cash and cash equivalents were approximately $27.4 million at September
30, 2024.
-- Net income for the three months ended September 30, 2024 was
approximately $3.2 million, or $0.04 per share, basic, and $0.03 per
share, diluted, compared to a net loss of $1.9 million, or $0.03 per
share, basic, and $0.04 per share, diluted, for the same period in 2023.
-- Since the end of the quarter ended September 30, 2024, the Company
collected approximately $3.9 million from sales to Chiesi.
Conference Call and Webcast Information
The Company will host a conference call today, November 14, 2024 at 8:30 a.m. EST, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date: Thursday, November 14, 2024
Time: 8:30 a.m. Eastern Standard Time $(EST.UK)$
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Israeli Toll Free: 1-809-406-247
Conference ID: 13749493
Call me$(TM)$: https://tinyurl.com/2n9fhumh
The Call me(TM) feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away.
Webcast Details:
Company Link: https://ir.protalix.com/news-events/events
Webcast Link: https://tinyurl.com/3be68pkw
Conference ID: 13749493
Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software. A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.
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