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Protalix BioTherapeutics Inc (PLX) Q4 2024 Earnings Call Highlights: Record Revenue Growth ...

Protalix BioTherapeutics Inc (PLX) Q4 2024 Earnings Call Highlights: Record Revenue Growth ...

Yahoo18-03-2025

Revenue from Selling Goods: $53 million for the year ended December 31, 2024, an increase of 31% from $40.4 million in 2023.
Revenue from License and R&D Services: $0.4 million for 2024, a decrease of 98% from $25.1 million in 2023.
Cost of Goods Sold: $24.3 million for 2024, an increase of 6% from $23 million in 2023.
Research and Development Expenses: $13 million for 2024, a decrease of 24% from $17.1 million in 2023.
Selling, General and Administrative Expenses: $12.2 million for 2024, a decrease of 19% from $15 million in 2023.
Financial Income, Net: $0.2 million for 2024, compared to financial expenses, net of $1.9 million in 2023.
Income Taxes: $1.2 million for 2024, an increase of 300% from $0.3 million in 2023.
Cash, Cash Equivalents, and Short-term Bank Deposits: Approximately $34.8 million as of December 31, 2024.
Net Income: $2.9 million for 2024, or $0.04 per share, compared to $8.3 million or $0.12 per share basic and $0.09 per share diluted in 2023.
Warning! GuruFocus has detected 4 Warning Signs with PLX.
Release Date: March 17, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Protalix BioTherapeutics Inc (PLX) achieved record revenues in 2024, driven by increased sales to partners like Chiesi and Pfizer.
The company fully repaid its outstanding debt, strengthening its balance sheet.
Protalix is advancing its R&D efforts, particularly with PRX-115, which completed a successful Phase 1 trial and is preparing for Phase 2.
The European Medicines Agency validated a new dosing regimen for Elfabrio, potentially expanding its market in the EU.
Protalix's collaboration with Chiesi is progressing well, with expectations of significant revenue growth from royalties by 2030.
Revenues from license and R&D services decreased by 98% due to the completion of the Elfabrio program.
The company expects minimal future revenues from license and R&D services, aside from potential milestone payments.
Net income decreased from $8.3 million in 2023 to $2.9 million in 2024, indicating a decline in profitability.
Research and development expenses decreased by 24%, which may impact the pace of new product development.
Protalix did not provide specific revenue guidance for 2025, creating uncertainty about future financial performance.
Q: When do you expect to provide revenue guidance, particularly regarding the royalty stream from Elfabrio, and what can you disclose about its progress? A: Chiesi, being a private company, does not disclose patient numbers or estimated revenues. However, they are adding patients globally to Elfabrio, and we anticipate revenues north of $100 million from Chiesi by 2030. Most revenues will be royalty-based, offering higher margins. We cannot provide guidance for 2025 due to inventory sales, but Chiesi's performance is promising, and our collaboration is strategic for Protalix. - Dror Bashan, President and CEO
Q: Can you explain the differences between PRX-119 and the historical PRX-110 program, and provide insights into the market opportunity for PRX-119? A: PRX-119 is a long-acting DNase, whereas PRX-110 was an acute one. We are finalizing indication selection and will update the market soon. Once the indication is finalized, we can provide potential market size details. - Dror Bashan, President and CEO
Q: What are the expected costs and timeline for the PRX-115 Phase 2 study, and will you seek a partner for further development? A: We plan to finance the Phase 2 study with current resources, estimating costs north of $20 million for third-party expenses. Topline results are expected in about two years, depending on enrollment pace. If results are positive, we will likely seek a commercial partner. - Dror Bashan, President and CEO
Q: Can you elaborate on the mechanism of action for PRX-115 and its impact on urate crystals in gout treatment? A: PRX-115 uses a uricase from a different source than KRYSTEXXA, with a specific peg covering the enzyme. In Phase 1, it reduced uric acid levels quickly and maintained low levels for extended periods. Further results in patients with severe gout will provide more insights. - Dror Bashan, President and CEO
Q: Do you have the 4Q Elfabrio revenue number available? A: The 10-K has been filed, which includes the 4Q Elfabrio revenue details. - Eyal Rubin, CFO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.

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Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma in Ongoing Multicenter Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma in Ongoing Multicenter Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

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time7 days ago

  • Business Wire

Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma in Ongoing Multicenter Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced initial Phase 1 safety and efficacy data from the Phase 1/2 Agni-01 multicenter study of OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma (NCT06060613). These data, summarized below, will be presented in a rapid oral presentation (abstract 9517) delivered by Jason A. Chesney, M.D., Ph.D., Director and Chief Administrative Officer of UofL Health – Brown Cancer Center/Oncology Service Line at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Obsidian is also presenting a poster for abstract 9519 summarizing translational data from the Phase 1 first-in-human single-center study of OBX-115 (NCT05470283, enrollment completed) in ICI-resistant advanced melanoma. Summary of OBX-115 Safety and Efficacy Data (March 26, 2025 data cutoff): Advancing a More Patient-centric TIL Cell Therapy Regimen in Heavily Pre-treated Advanced Melanoma Patient Population Patients had disease that was predominantly ICI primary-resistant, with a median of 4 (range, 1–6) lines of prior systemic therapy, including a median of 2 (1–5) lines of prior ICI therapy (n=11). 10 patients received low-dose lymphodepletion (approximately 50% less Cyclophosphamide relative to non-engineered TIL), including 1 in the outpatient setting. Acetazolamide (ACZ) redosing following initial OBX-115 infusion to drive re-activation of OBX-115 cells was tolerable and safe enough to administer at home. OBX-115 Continues to Deliver Positively Differentiated Safety Profile Relative to Non-engineered TIL; No IL2, No Treatment-related Mortality: No dose-limiting toxicities were observed at any dose level. No Grade 4 or higher nonhematologic treatment-related adverse events (TRAEs) were reported; 5 patients experienced limited Grade 3 nonhematologic TRAEs. No confirmed events of cytokine release syndrome or infusion-related reaction higher than Grade 2; no capillary leak syndrome or immune effector cell-associated neurotoxicity syndrome were reported. No treatment-related ICU transfer, no treatment-related mortality. OBX-115 Maintains Consistent Efficacy Profile Without IL2 and With Low-dose Lymphodepletion in Anti-PD-1-resistant Advanced Melanoma; Dose Level 3 (RP2D) To Be Further Explored in Phase 2 Encouraging efficacy profile observed at the RP2D (n=6) 66.7% ORR, including 1 confirmed CR and 3 confirmed PRs (investigator-assessed RECIST 1.1 criteria) Durable clinical benefit, including 3 of 4 responses ongoing at week 24 / data cutoff (median duration of response not reached) 100% disease control rate, defined as stable disease or better for ≥12 weeks post-infusion 36.4% objective response rate (ORR) across all dose levels (n=11) Majority had reduction in tumor burden reduction: 83% at RP2D; 73% across all dose levels. Dr. Chesney commented, 'It is very encouraging to see the promising safety and efficacy profile for OBX-115, now observed in the Agni-01 multicenter study. 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'Listen to the people. That's your job'; Council torn, residents upset with new city manager hire
'Listen to the people. That's your job'; Council torn, residents upset with new city manager hire

Yahoo

time28-05-2025

  • Yahoo

'Listen to the people. That's your job'; Council torn, residents upset with new city manager hire

SPRINGFIELD, Mo. — Residents like Angela Pryor didn't mince words about her frustrations with Springfield City Council Tuesday afternoon. 'The Council has circumvented the process of making this very, very important decision for the entire city,' Pryor said. 'It was confirmed that a number of people did come forward in the last few days and have tried to make their truth known and that the truth from this from the citizens is overwhelmingly in disagreement with this decision, the process and the person, and that we wanted them to restart the search process, especially in light of the fact that the salary of the city manager will now be the highest in the state of Missouri, and we deserve a more experienced city manager.' Springfield City Council voted 5-4 to approve a contract to essentially hire David Cameron as the new city manager, months after the announced departure of Jason Gage. Councilmembers Craig Hosmer, Bruce Adib-Yazdi, Monica Horton, and Brandon Jenson all voted no on Cameron's approval. Councilmembers Callie Carroll, Abe McGull, Derek Lee and Heather Hardinger voted yes. Newly elected Mayor Jeff Schrag broke the tie, voting yes. 'Listen to the people. That's your job. I think our new manager and our new mayor has really, really ignored the process for the people and the voice of the people, and it's not a great start for [Schrag's] term,' Pryor said. 'I think [Schrag's] leadership is at question.' The meeting started with a reading from Mayor Schrag, explaining the process behind the vote being on Tuesday, rather than the next scheduled city council meeting on June 9. 'We will not have a full council present on June 9. The next council meeting after June nine is Monday, June 23, only two weeks weeks prior to the start date outlined in Council Bill 2025-115. I do not think there is enough time between the official vote and the start date. Therefore, I have deemed the vote to be time sensitive,' Schrag said in the meeting. Councilman Hosmer immediately called for a vote to table the issue until a later meeting. 'I'd like to know why we're fast tracking this bill. It is not emergency. It's not time sensitive, and nothing in the contract requires us to have the bill [voted on] before the start date on July 7,' Hosmer said. 'This is a departure from the precedent that the city council is operating under for at least the 12 years that I've been on council. This, again, is not a normal city council meeting where the public can tune in, listen and watch, and even find out what happens. We've been very deliberate in our process so far in this candidate's selection. We have consistently, as a council said, we're not going to rush the process, and so the question I have today is why are we rushing the process now?' Hosmer continued to give advice to those about to vote. 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I will be voting against the bill, but I am going to be supportive of the city manager if it is the council's choice to do so.' Hosmer was not alone with concerns. 'I just wanted to acknowledge the fact that I figured that we would have a latent response from the public. We did have a latent response from the public over the last three days. I know I've received over 70 pieces of feedback, emails, phone calls and face to face from the public,' Councilwoman Monica Horton said. 'I feel as though that that particular set of information to the city council is something that we need to take into consideration, and what I've heard over the past three days in terms of just summing up is that, number one, they wanted us to table. That failed. Number two, they certainly wanted us to start this search over for reasons that in the previous council meeting, Councilman Jenson, he went over a whole litany of issues, and for the reasons that Councilman Hosmer is laying out today. 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He brings people to the table, he's solutions-oriented and he also holds himself and others accountable, and that's what I want in a city manager,' Carroll said. 'I would have had concern if this would have been our public hearing. We had our public hearing last Monday night where people could come and people did come and voice their concerns, voiced their support. We heard that us as councilmembers. We also spoke after that meeting. During that meeting, we spoke, and we've heard all of these things. Today was just the procedural part of the vote. So it was put out many weeks in advance that this would be what would happen. I do think it's the right choice, especially considering we would have had to push it to the end of the month with council members being absent for the next meeting. I do think it was the right thing to move forward with this. We haven't had a city manager for seven months. It's time to move forward.' 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While I won't be present for the official announcement due to a previously scheduled mental health retreat, I want to express my deep appreciation for the trust the Mayor, City Council, and community extended to me,' Cameron said. Cameron continued, 'This is not about one individual; it's about what we can accomplish together in Springfield, across the region, and throughout Missouri. I understand this decision was not unanimous, and I respect those who voted differently. Their commitment to public service is evident, and I look forward to earning their trust through our shared work ahead.' 'I want to sincerely thank the City of Republic, Mayor Franklin, City Council, dedicated staff, and the incredible community for allowing me to come back home and serve over the past nine years,' Cameron said. 'We built something special together, and I carry that same regional mindset with me into this next chapter.' 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Jefferies Downgrades Prothena Corporation (PRTA) After Negative Trial Results
Jefferies Downgrades Prothena Corporation (PRTA) After Negative Trial Results

Yahoo

time27-05-2025

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Jefferies Downgrades Prothena Corporation (PRTA) After Negative Trial Results

On May 27, Jefferies downgraded Prothena Corporation plc (NASDAQ:PRTA) to Hold from Buy and slashed the price target to $6 from $32. The considerable price target reduction followed the company's announcement regarding the discontinuation of its Phase 3 AFFIRM-AL clinical trial for Birtamimab in AL Amyloidosis patients, as it could not meet the primary and secondary endpoints. A biopharmaceutical research lab with a team of scientists working on immunomodulatory therapies. The analyst told investors in a research note that Prothena Corporation's (NASDAQ:PRTA) Phase III study in light-chain amyloidosis has failed for the second time, which is why it is discontinuing the study and reducing opex related to birtamimab. While more updates are expected in June, the next investor focus is on PRX-012 Phase I/II for Alzheimer's. Data for PRX-012 Phase I/II is expected to roll out by August. However, Jeffries expressed caution regarding the results, as they may not show significant efficacy. Prothena Corporation (NASDAQ:PRTA) is a clinical-stage neuroscience company that discovers and develops novel therapies for serious diseases. Its clinical pipeline includes both partnered and wholly owned therapies for AL amyloidosis, Alzheimer's disease, ATTR amyloidosis, Parkinson's disease, and other neurodegenerative diseases. While we acknowledge the potential of TGT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than TGT and that has 100x upside potential, check out our report about the . READ NEXT: and . Disclosure: None.

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