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Protalix BioTherapeutics Inc

Protalix BioTherapeutics Inc (PLX)

1.395
-0.005
(-0.36%)
1.39
-0.005
(-0.36%)

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Key stats and details

Current Price
1.39
Bid
-
Ask
-
Volume
772,581
1.34 Day's Range 1.44
0.8214 52 Week Range 3.10
Market Cap
Previous Close
1.40
Open
1.43
Last Trade
11047
@
1.4
Last Trade Time
Financial Volume
$ 1,061,852
VWAP
1.3744
Average Volume (3m)
914,681
Shares Outstanding
79,607,115
Dividend Yield
-
PE Ratio
37.77
Earnings Per Share (EPS)
0.04
Revenue
53.4M
Net Profit
2.93M

About Protalix BioTherapeutics Inc

Protalix BioTherapeutics Inc is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system or ProCellEx. It has developed taliglucerase alfa for the treatment of Gaucher disease. The co... Protalix BioTherapeutics Inc is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system or ProCellEx. It has developed taliglucerase alfa for the treatment of Gaucher disease. The company's products also treat diseases like Fabry disease and cystic fibrosis.The company's primary sources of revenues include its sales of taliglucerase alfa in Brazil and of drug substance to Pfizer under its Amended Pfizer Agreement. Show more

Sector
Biological Pds,ex Diagnstics
Industry
Management Services
Website
Headquarters
Wilmington, Delaware, USA
Founded
2007
Protalix BioTherapeutics Inc is listed in the Biological Pds,ex Diagnstics sector of the American Stock Exchange with ticker PLX. The last closing price for Protalix BioTherapeutics was $1.40. Over the last year, Protalix BioTherapeutics shares have traded in a share price range of $ 0.8214 to $ 3.10.

Protalix BioTherapeutics currently has 79,607,115 shares outstanding. The market capitalization of Protalix BioTherapeutics is $111.45 million. Protalix BioTherapeutics has a price to earnings ratio (PE ratio) of 37.77.

PLX Latest News

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.13-8.552631578951.521.561.375600511.42078853CS
4-0.26-15.75757575761.651.681.376307611.5439148CS
12-1.2-46.3320463322.593.11.379146812.04622231CS
26-0.3-17.75147928991.693.11.377784662.17980791CS
520.2319.82758620691.163.10.82145259821.93508128CS
1560.3229.90654205611.073.550.82146079811.95024271CS
260-2.65-65.59405940594.047.020.78300222.09705988CS

PLX - Frequently Asked Questions (FAQ)

What is the current Protalix BioTherapeutics share price?
The current share price of Protalix BioTherapeutics is $ 1.39
How many Protalix BioTherapeutics shares are in issue?
Protalix BioTherapeutics has 79,607,115 shares in issue
What is the market cap of Protalix BioTherapeutics?
The market capitalisation of Protalix BioTherapeutics is USD 111.45M
What is the 1 year trading range for Protalix BioTherapeutics share price?
Protalix BioTherapeutics has traded in the range of $ 0.8214 to $ 3.10 during the past year
What is the PE ratio of Protalix BioTherapeutics?
The price to earnings ratio of Protalix BioTherapeutics is 37.77
What is the cash to sales ratio of Protalix BioTherapeutics?
The cash to sales ratio of Protalix BioTherapeutics is 2.07
What is the reporting currency for Protalix BioTherapeutics?
Protalix BioTherapeutics reports financial results in USD
What is the latest annual turnover for Protalix BioTherapeutics?
The latest annual turnover of Protalix BioTherapeutics is USD 53.4M
What is the latest annual profit for Protalix BioTherapeutics?
The latest annual profit of Protalix BioTherapeutics is USD 2.93M
What is the registered address of Protalix BioTherapeutics?
The registered address for Protalix BioTherapeutics is 108 W. 13TH STREET, SUITE 100, WILMINGTON, DELAWARE, 19801
What is the Protalix BioTherapeutics website address?
The website address for Protalix BioTherapeutics is protalix.com
Which industry sector does Protalix BioTherapeutics operate in?
Protalix BioTherapeutics operates in the MANAGEMENT SERVICES sector

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PLX Discussion

View Posts
BooDog BooDog 1 month ago
Triggered a stop loss at 1.49 yesterday for a chunk. I hate bleeders. And of course this puppy bounced. Still closed that position green but only by a few %. I took a bunch off around the $3 but still.

No matter how long I'm at this I can STILL make the wrong call.
👍️ 1
midastouch017 midastouch017 1 month ago
Oy-Vey!
👍️ 1
Monksdream Monksdream 1 month ago
PLX 10 day chart
👍️0
midastouch017 midastouch017 1 month ago
Best of luck to you mate, i am still here
due to academic reasons only, no
financial interest here.
👍️ 1
BooDog BooDog 1 month ago
Yeah, I'm thinking we're in good shape here. I'm still thinking there's merge potential as well.

To date, we have successfully developed two commercial products, both of which are enzyme replacement therapies (ERTs): Elfabrio® (pegunigalsidase alfa) for the treatment of adult patients with a confirmed diagnosis of Fabry disease and Elelyso® (taliglucerase alfa) for the treatment of adult patients with Gaucher disease. Elelyso was first approved by the FDA in May 2012 and is now approved for marketing in 23 markets including Brazil, Israel and others. Elfabrio, which we referred to as PRX-102 during its development stage, has been approved for marketing in the United States, the European Union, Great Britain, Switzerland, Peru, Israel, Russia and Singapore. We have licensed the rights to commercialize Elelyso worldwide (other than Brazil) to Pfizer, and in Brazil to Fiocruz. Elelyso is marketed as BioManguinhos alfataliglicerase in Brazil. We have partnered with Chiesi for the development and commercialization of Elfabrio.

In addition, we are developing PEGylated uricase, or PRX-115, for the treatment of uncontrolled gout, Long Acting (LA) DNase I, or PRX-119, for the treatment of NETs-related diseases, and a number of other technologies and preclinical assets. We have completed a phase I First-in-Human clinical trial of PRX-115 and we are currently in the advance stages of preparations for a phase II clinical trial of PRX-115 which we expect to commence in the second half of 2025.

Pipeline
👍️0
midastouch017 midastouch017 1 month ago
Wait till they announce the price
of the offering at $1.50 or so.
Beware!
👍️0
BooDog BooDog 1 month ago
Earnings were good and the future looks good too imo. Way over reaction here. Typical manipulation triggering stop losses all over the place.
👍️0
midastouch017 midastouch017 1 month ago
No doubt. @$1.72, a bargain price
👍️0
BooDog BooDog 1 month ago
Reloaded here. 1.80. Support right at 1.72 imo. See if it holds.
👍️0
midastouch017 midastouch017 1 month ago
Small wonder the CFO took off,
he saw the downfall a-coming!
👍️0
midastouch017 midastouch017 1 month ago
Protalix BioTherapeutics GAAP EPS of -$0.05 misses by $0.13, revenue of $10.11M misses by $11.49M

May 09, 2025 6:56 AM ETProtalix BioTherapeutics, Inc. (PLX) Stock

By: Meghavi Singh, SA News Editor

Protalix BioTherapeutics press release (NYSE:PLX): Q1 GAAP
EPS of -$0.05 misses by $0.13.

Revenue of $10.11M (+169.6% Y/Y) misses by $11.49M.

Cash, cash equivalents and short term bank deposits were approximately $34.7 million at March 31, 2025.
👍️0
BooDog BooDog 2 months ago
I was thinking that too. Still, this is an excellent swing stock imo. Still watching the reset.
👍️ 1
midastouch017 midastouch017 2 months ago
The market fears the offering price to be
announced, hence the decline.
That's the immediate news you will get.
👍️0
BooDog BooDog 2 months ago
That's a sweet looking chart. Like to see that here too!

RGLS

PLX
👍️0
Stumblebum Stumblebum 2 months ago
Hopefully something on the order that RGLS got today
👍️0
BooDog BooDog 2 months ago
Over $3. See what news we get.
👍️0
BooDog BooDog 2 months ago
Needs to get over $4 to get back under.

This puppy has been a great swing stock. Thinking $2.50's for a fair reset. Will be watching. Keeping a fair position for now as well.

Cheers
👍️0
Monksdream Monksdream 2 months ago
PLX, under $4
👍️0
downthehatch downthehatch 2 months ago
+$3 is coming..... maybe before Q1 report?
👍️0
BooDog BooDog 2 months ago
I've been looking for this to break out for over a month. At least to get over $3
👍️0
Monksdream Monksdream 2 months ago
PLX, new 52 week high
👍️0
BooDog BooDog 2 months ago
Very good look to it now. Potential blue skies. I've been playing this one for a while.

52W Range 0.82 - 2.76
👍️0
Monksdream Monksdream 2 months ago
PLX, off the 52 week low
👍️0
BooDog BooDog 3 months ago
Nice indicators on the charts imo. See if it can break through to $3.

PLX daily
👍️0
BooDog BooDog 3 months ago
52W high 2.76 Breakout potential

Daily...

PLX

Blue sky ppotential.
👍️0
Monksdream Monksdream 4 months ago
PLX, buy the dip?
👍️0
BooDog BooDog 6 months ago
Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfa

https://www.prnewswire.com/news-releases/chiesi-global-rare-diseases-and-protalix-biotherapeutics-announce-validation-of-variation-submission-by-european-medicines-agency-for-pegunigalsidase-alfa-302325589.html
👍️0
TrendTrade2016 TrendTrade2016 7 months ago
PLX BIO BEAST READ TO BEAST
👍️0
Rein07 Rein07 7 months ago
on approval it reached $3.4 - now that they are cash positive for the first quarter, we might watch that earlier then thought. Our target in 12m is $14+
👍 1
BooDog BooDog 9 months ago
Form 4...

https://ih.advfn.com/stock-market/AMEX/protalix-biotherapeutics-PLX/stock-news/94604993/form-4-statement-of-changes-in-beneficial-owners


1. Represents fully-vested restricted shares of common stock of Protalix BioTherapeutics, Inc., awarded to the Reporting Person under the Amended and Restated Protalix BioTherapeutics, Inc. 2006 Stock Incentive Plan, as amended.
👍️0
midastouch017 midastouch017 10 months ago
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® plant cell-based protein expression system, today announced that it has repaid in full all of the outstanding principal and interest payable under its 7.50% Senior Secured Convertible Promissory Notes. The repayment of the convertible notes at maturity was financed entirely with available cash.

"Repayment of our convertible notes is a significant milestone for our company as we are now debt-free and have eliminated the potential equity overhang presented by the notes," said Dror Bashan, Protalix's President and Chief Executive Officer. "Over the last decade, our company has been financed in part through the issuance of convertible notes, the total outstanding principal amount of which reached $78.0 million at its highest. Given this repayment, our financial discipline has resulted in a strong balance sheet that is sufficient to support our planned ongoing operations."

https://www.streetinsider.com/Corporate+News/Protalix+BioTherapeutics+%28PLX%29+Repays+Outstanding+Senior+Secured+Convertible+Promissory+Notes/23677145.html
👍️0
BooDog BooDog 10 months ago
Over the $
👍️0
jcon777 jcon777 10 months ago
I am not very confident how reliable this is for predicting PLX earnings.
https://www.earningswhispers.com/stocks/PLX
👍️0
Monksdream Monksdream 11 months ago
PLX under $2
👍️0
Monksdream Monksdream 11 months ago
PLX under $2
👍️0
Monksdream Monksdream 11 months ago
PLX under $2
👍️0
BooDog BooDog 12 months ago
I don't think so. Idiots they are. Float is so tiny. Yet, I have seen stupid shit like that happen. Ridiculous. MILLIONS and I could give a hoot for my position. But really!? Is this THAT far fetched it doesn't have a chance?

Sweating my ass off here. Pool time.
👍️0
king oil king oil 12 months ago
It wants to go below $1 so they can RS yet again. Happy days for Dror.
👍️0
BooDog BooDog 12 months ago
New 52 WK low. See if it holds the $..

PLX daily
👍️0
BooDog BooDog 1 year ago
Roll this puppy on up!
👍️0
king oil king oil 1 year ago
Because there weren’t any
👍️0
jcon777 jcon777 1 year ago
Anyone have any ideas why we did not hear any good discussions or questions about more Elfabrio sales?
👍️0
Monksdream Monksdream 1 year ago
PLX new 52 week low
👍️0
BooDog BooDog 1 year ago
Thinking this may see under the $. I'm keeping this on the radar and have already started accumulating again.
👍️0
Monksdream Monksdream 1 year ago
PLX under $2
👍️0
king oil king oil 1 year ago
It’s unlikely with the current incompetent management.
👍️0
jcon777 jcon777 1 year ago
So we wait again for 3 more months.
Maybe the elfabrio sales in 3 months will finally get the stock to go up and stay up, and by the end of the year (just 9 months) we finally see this as the winner that we hoped for.
👍️0
king oil king oil 1 year ago
That was one of the worst earnings call ever.
👍️0
midastouch017 midastouch017 1 year ago
Protalix BioTherapeutics, Inc. (PLX) Q4 2023 Earnings Call Transcript

Mar. 14, 2024 1:02 PM ETProtalix BioTherapeutics, Inc. (PLX) Stock

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q4 2023 Earnings Conference Call March 14, 2024 8:30 AM ET

Company Participants

Lauren Merrick - Investor Relations

Dror Bashan - President and Chief Executive Officer

Eyal Rubin - Senior Vice President and Chief Financial Officer

Conference Call Participants

John Vandermosten - Zacks

Operator

Good morning, ladies and gentlemen and welcome to the Protalix BioTherapeutics Fiscal Year 2023 Financial and Business Results Conference Call. As a reminder, this conference call is being recorded. I’ll now turn the conference over to our host, Ms. Lauren Merrick [ph] of LifeSci Advisors, Investor Relations for Protalix. You may now begin.

Lauren Merrick

Thank you, Rob and welcome to the Protalix BioTherapeutics fiscal year 2023 financial results and business update conference call. With me today are Dror Bashan, President and CEO of Protalix; and Eyal Rubin, Senior Vice President and Chief Financial Officer.

A press release announcing the results and the update was issued this morning and is available now on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Protalix’s filings with the U.S. Securities and Exchange Commission.

I will now turn the call over to Mr. Dror Bashan. Dror?

Dror Bashan

Thank you, Lauren and welcome everyone to our fiscal year 2023 financial results and business update call. I will begin by reviewing our accomplishments over the past year and recent progress. Following my remarks, Eyal will provide a more detailed review of our financial results. We will then open the line for questions.

2023 marks a significant year for Protalix as we received regulatory approval for our second drug Elfabrio, for the treatment of adult patients with Fabry disease. In May of 2023, both the FDA and the EMA approved Elfabrio for the treatment of adult patients with Fabry disease. Since then, Elfabrio has been granted additional regulatory approvals in other markets like UK, Sweden and the most recently in Israel as well. Our commercial partner, Chiesi global rare diseases remains focused on the commercial launches, which are underway in the United States, in the European Union, in the UK and additional markets where approvals are granted. We are confident that Chiesi will continue to position Elfabrio for success, and we look forward to continued growth of our Elfabrio franchise. Elfabrio is now the second approved drug expressed via our propriety plant, coal-based protein expression system, Protalix, which further highlights the success of our unique platform with these significant milestones behind us and while we are supporting Chiesi’s operations.

We are continuing to focus on building our – the development of our pipeline of innovative assets for the treatment of genetic and non-genetic rare diseases. Our next clinical development candidate is PRX-115, which is being developed for the potential treatment of severe gout. PRX-115 is a recombinant pegylated uricase product candidate that is also produced using our Protalix platform. In March of 2023, we have initiated a Phase 1 first in human clinical trial of PRX-115 to evaluate its safety, pharmacokinetics, pharmacodynamics and immunogenicity. This is a double-blind placebo-controlled single ascending dose study being conducted in New Zealand in approximately 56 patients with elevated uric acid levels. We are pleased to announce that the trial is now fully enrolled, and we expect to report preliminary results from this study in the second quarter of 2024. Our next pipeline of candidate also being expressed for Protalix is PRS-119. PRX-119 is a pegylated recombinant human DNS1 candidate in developing for the potential treatment of diseases associated with neutrophil extracellular scraps or NES. Additional preclinicals are ongoing, and we will update you accordingly, of course.

In addition to PRX-115 and PRX-119, we have multiple preclinical programs in progress, and we look forward to providing you with the updates on these potential development candidates as they become more mature. On the corporate side, in 2023, we welcome Dr. Eliott Foster as Chairman of our Board of Directors and a member of our nominating committee. Dr. Foster succeeded [indiscernible] who retired and we are grateful to the very dedication and leadership since the founding of Protalix. And we are grateful for Eliot’s contribution thus far as we prepare for an exciting phase of development of the company.

Finally, and before turning the call over to Eyal, I want to note that our strong balance sheet provides us with sufficient cash runway to support our operations and in addition, as Eyal will discuss, sales of Elfabrio to Chiesi increased after regulatory approval of Elfabrio, while Chiesi builds its inventories to support a successful launch. We expect sales to clearly – to gradually continue as they anticipate future approvals and launches in additional countries throughout the world.

With that, it is now my pleasure to turn the call over to Eyal for a review of our financials. And Eyal, please go ahead.

Eyal Rubin

Thank you, Dror. And thank you everyone for joining todays call. Let me review our fiscal year 2023 financials. We recorded revenues from selling goods of $40.4 million for the year ended December 31, 2023, an increase of $15.1 million or 60% compared to revenues of $25.3 million for the year ended December 31, 2022. The increase resulted primarily from an increase of $14.1 million in sales of Elfabrio drug product to Chiesi following the approval by the FDA and the EMA of Elfabrio as Dror described, an increase of $0.1 million in sales to Pfizer and of $0.9 million in sales to Brazil.

We recorded revenues from license and R&D services of $25.1 million for the year ended December 31, 2023, an increase of $2.8 million or 13% compared to revenues of $22.3 million for the year ended December 31, 2022. The increase resulted from the $20 million regulatory milestone payment from Chiesi in connection with the FDA approval of Elfabrio, which was partially offset by a decrease of $17.2 million in revenues recognized in connection with the R&D performance obligation under the Chiesi agreement as the company has completed the Phase 3 clinical program thereunder.

Revenues from license and R&D services represent primarily the revenues the company recognized for services provided under the Chiesi agreement. Cost of goods sold was $23 million for the year ended December 31, 2023, an increase of $3.4 million or 17% compared to cost of goods sold of $19.6 million for the year ended December 31, 2022. The increase in cost of goods sold was primarily the result of increase in sales of goods per for Chiesi Brazil and Pfizer. Sales to Chiesi included certain drug substance costs, which had already been recognized as research and development expenses as it was produced as part of the research and development activities.

Accordingly, the related cost of goods sold does not include the cost of subs. For the year ended December 31, 2023, the company total research and development expenses were approximately $17.1 million, comprised of approximately $6.3 million subcontractor related expenses, approximately $7.8 million of salary-related expenses, approximately $0.6 million of material-related expenses and approximately $2.4 million of other expenses. For the year ended December 31, 2022, the company’s total research and development expenses were approximately $29.3 million, comprised of approximately $17.8 million in sub-contractor related expenses, approximately $7.3 million of salary and related expenses, approximately $1.4 billion of material-related expenses and approximately $2.8 million of other expenses.

The decrease in research and development expenses was $12.2 million or 42% for the year ended December 31, 2023, compared to the year ended December 31, 2022. The decrease in issues and development expenses resulted primarily from $11.5 million decrease in subcontractor-related expenses in connection with the PRX-102 clinical trials and a $0.8 million decrease in materials related expenses.

Selling, general and administrative expenses were $15 million for the year ended December 31, 2023, an increase of $3.3 million or 28% from $11.7 million for the year ended December 31, 2022. The increase resulted primarily from an increase of approximately $2.3 million in one-time cash bonuses, share-based compensation and salary and related expenses as well as an increase of $0.3 million in travel conferences and employee training expenses. Financial expenses net was $1.9 million for the year ended December 31, 2023, an increase of $0.5 million or 36% compared to financial expenses of $1.4 million for the year ended December 31, 2022. The increase was primarily due to a decrease of $0.9 million in income related to exchange rates as well as an increase in interest expenses of $0.7 million which was partially offset by a gain recognized due to the conversion of a portion of the 2024 notes of $0.4 million and $0.6 million increase in interest income.

For the year ended December 31, 2023, we recorded income taxes of approximately $0.3 million, a decrease of $0.2 million or 40% compared to tax expenses of $0.5 million for the year ended December 31, 2022. The income taxes resulted primarily from the provision for current taxes and income mainly derived from U.S. taxable global intangible low tax income duty, mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over 5 years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States rather than deducting such costs in the current year.

The net income taxes gives effect to a valuation allowance release equal to approximately $3.1 million. Cash and cash equivalents and short-term bank deposits were approximately $44.6 million at December 31, 2023. Net income for the year ended December 31, 2023, was approximately $8.3 million or $0.12 per share basic and $0.09 per share diluted compared to a net loss of $14.9 million or $0.31 per share basic and diluted for the same period in 2022.

I will now turn the call back to you, Dror.

Dror Bashan

Thank you, Eyal. I would like to conclude by expressing how pride we are on of all that Protalix has accomplished throughout 2023. With two drugs expressed via our proven platform are now approved, we are continuing to build our expertise to develop a type of assets to potentially transform the treatment of rare disease. I am grateful for a world-class team who constantly demonstrate unwavering commitment to our mission. We look forward to updating you on our progress as we continue to drive innovation and create long-term value for the patients and stockholders.

Now, I would like to ask the operator to open the call for questions.

Question-and-Answer Session

Operator

[Operator Instructions] And our first question comes from the line of John Vandermosten with Zacks. Please proceed with your question.

John Vandermosten

Great. Thank you and good afternoon Dror and Eyal. If I start off with a question about some of the PRX-102 studies that are going on, I noticed you had one in Japan and one in the United States for pediatric. Can you give us a timeline on how long those might take and what the next steps would be there to get approvals for Japan and for pediatric indication?

Dror Bashan

So, thank you, John. Actually, this study, this is – and are conducted by Chiesi and this is their responsibility. So, I don’t have the timeline in front of me, of course. And this is for them actually to address that. But you can understand that they put a lot of attention and resources into expanding if I may say the franchise, this is clear.

John Vandermosten

Yes. Great. It sounds like they have a lot of opportunities out there. And also, you may not have gotten a lot of information from Chiesi on this, but when you look at your revenues and kind of expenditures for the year, how should we think of those balancing out in terms of free cash flow on the bottom line? Are they going to be pretty equal based on the view right now? Is that how you are planning going forward?

Eyal Rubin

Hey. Thanks for the question, John. So, I don’t know what equal means. But as Dror mentioned, gradually, we expect the sales obviously to grow. And in terms of the free cash flow, it depends how much money you are going to invest in the early stage and the later stage R&D. As I mentioned in previous calls, the sales to Chiesi are comprised of an inventory buildup as well as obviously, commercial sales to the enrolled commercial patients. We expect that these sales are going to eventually grow and gradually, we will get to the place, as we indicated in our presentation, that we believe that Chiesi with a good job can they take in the market.

John Vandermosten

Got it. And then looking at PRX-115, you had mentioned that there is going to be results from that, it seems like in the next couple of weeks. What – assuming those are positive, what are the next steps for that program? Is that Phase 2, or might there be some other pursuit there?

Dror Bashan

So, if indeed, we continue to go forward, of course, when we move into a Phase 2, yes.

John Vandermosten

Okay. And would that be before the end of this year that you would start that Phase 2?

Dror Bashan

This depends – I think it will be between the end to the first half of next year, yes.

John Vandermosten

The first half of next year, okay. Got it. And then last question on PRX-119. What are the next steps for that? Is that something you might put into the clinic this year?

Dror Bashan

Not yet. We are looking into the right indication to continue with. I think this will take further a bit more to decide.

John Vandermosten

Okay. And then any other milestones on the R&D side that we should think about as we progress through 2024?

Dror Bashan

Once there will be something to update, we will update, of course. We are not exactly sitting on our hands. Well, I think we will pretty much, I would say, even intensively in order to make sure that we can add the additional early-stage assets. It is just – we take our time, and I hope we will cut the right move, but will make sense.

John Vandermosten

Okay. Alright. Thank you, Dror. Thank you, Eyal for your answers.

Dror Bashan

You’re welcome.

Operator

[Operator Instructions] Thank you. At this time, there are no additional questions. Gentlemen, would you want to make some further remarks.

Dror Bashan

So, this is to Dror speaking. I just would like to thank everybody again for the time, and again, to thank our shareholders and our employees for supporting us and moving on with our commitment. And we will – of course, we will update you accordingly on any sort of development, and we will meet in the next earnings update. Thank you.

Operator

This will conclude today’s conference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.

Eyal Rubin

Thank you.
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midastouch017 midastouch017 1 year ago
Protalix BioTherapeutics Reports Fiscal Year 2023 Financial and Business Results

https://finance.yahoo.com/news/protalix-biotherapeutics-reports-fiscal-2023-105000190.html


Company to host conference call and webcast today at 8:30 a.m. EDT

CARMIEL, Israel, March 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® plant cell-based protein expression system, today reported financial results for the fiscal year ended December 31, 2023, and provided a business update.

"2023 was a significant year for Protalix, as we received regulatory approvals of Elfabrio for the treatment of adult patients with Fabry disease and advanced our growing pipeline," said Dror Bashan, Protalix's President and Chief Executive Officer. "As the second drug produced through our proven protein expression platform, Elfabrio's approval is a welcome milestone for Fabry disease patients and their families. Our commercial partner Chiesi Global Rare Diseases is continuing to position Elfabrio for global success, with launches underway in the United States, the European Union, the UK and additional markets where approvals were granted. As we continue to provide Chiesi with operational support for its activities, we have turned our attention to developing our innovative pipeline. For example, PRX-115, our proprietary recombinant PEGylated uricase for the treatment of severe gout, is currently being studied in a first-in-human phase I clinical trial. We anticipate that results from the trial will be published in the second quarter of 2024. As a company powered by a professional team and solid financials, and with the potential for revenue growth, we are poised for an exciting future and look forward to making a positive impact on patients' lives and delivering long-term value to our stockholders."

Fiscal Year 2023 and Recent Business Highlights

Regulatory and Commercial Advancements

The Company, together with its development and commercialization partner, Chiesi Global Rare Diseases (Chiesi), a business unit of the Chiesi Group, gained marketing authorizations in the United States, the European Union, the UK, Switzerland and Israel for Elfabrio® (pegunigalsidase alfa), a PEGylated recombinant human a-Galactosidase-A enzyme, for the treatment of adult patients with confirmed Fabry disease. Elfabrio is administered via intravenous infusion at a dose of 1 mg/kg every two weeks.

On May 5, 2023, the Company announced that the European Commission (EC) granted marketing authorization to Elfabrio in the European Union for the treatment of adult patients with Fabry disease.

On May 10, 2023, the Company announced that the U.S. Food and Drug Administration (FDA) approved Elfabrio in the United States for the treatment of adult patients with Fabry disease.

On August 15, 2023, Chiesi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Elfabrio in Great Britain for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.

On September 11, 2023, Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland, announced the approval of Elfabrio in Switzerland for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.

In January 2024, the Israeli Ministry of Health granted principle approval of Elfabrio for adult patients with a confirmed diagnosis of Fabry disease.

The FDA approval triggered a $20.0 million milestone payment from Chiesi. In addition, the Company generated $17.5 million from sales of Elfabrio to Chiesi during 2023 post-regulatory approval, as Chiesi is building its inventory and recruiting commercial patients in the United States and Europe.

Clinical Developments

In March 2023, the first patient was dosed in the Company's First in Human (FIH) Phase I clinical trial of PRX–115, a recombinant PEGylated uricase product candidate under development as a potential treatment for severe gout. The FIH trial is a double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX–115 in approximately 56 patients with elevated uric acid levels (>6.0 mg/dL) and no previous exposure to PEGylated uricase. The study, which is fully-enrolled, is being conducted at the New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines. The Company anticipates that preliminary results from the study will be published in the second quarter of 2024.

Corporate Developments

On September 14, 2023, Eliot Richard Forster, Ph.D. began his tenure as Chairman of the Board of Directors, replacing former Chairman Zeev Bronfeld, who retired for personal reasons.

Fiscal Year 2023 Financial Highlights

The Company recorded revenues from selling goods of $40.4 million for the year ended December 31, 2023, an increase of $15.1 million, or 60%, compared to revenues of $25.3 million for the year ended December 31, 2022. The increase resulted primarily from an increase of $14.1 million in sales of Elfabrio drug product to Chiesi, following the approvals by the FDA and the European Medicines Agency (EMA) of Elfabrio, an increase of $0.1 million in sales to Pfizer Inc., or Pfizer, and of $0.9 million in sales to Brazil, resulting from timing differences.

The Company recorded revenues from license and R&D services of $25.1 million for the year ended December 31, 2023, an increase of $2.8 million, or 13%, compared to revenues of $22.3 million for the year ended December 31, 2022. The increase resulted from the $20.0 million regulatory milestone payment from Chiesi in connection with the FDA approval of Elfabrio which was partially offset by a decrease of $17.2 million in revenues recognized in connection with the R&D performance obligation under the Chiesi Agreements as the Company has completed the phase III clinical program thereunder. Revenues from license and R&D services represent primarily the revenues the Company recognized for services provided under the Chiesi Agreements.

Cost of goods sold was $23.0 million for the year ended December 31, 2023, an increase of $3.4 million, or 17%, compared to cost of goods sold of $19.6 million for the year ended December 31, 2022. The increase in cost of goods sold was primarily the result of the increase in sales of goods to Chiesi, Brazil and to Pfizer. Sales to Chiesi included certain drug substance costs which had already been recognized as research and development expenses as it was produced as part of research and development activities. Accordingly, the related cost of goods sold does not include the costs of such drug substance.

For the year ended December 31, 2023, the Company's total research and development expenses were approximately $17.1 million, comprised of approximately $6.3 million in subcontractor-related expenses, approximately $7.8 million of salary and related expenses, approximately $0.6 million of materials-related expenses and approximately $2.4 million of other expenses. For the year ended December 31, 2022, the Company's total research and development expenses were approximately $29.3 million, comprised of approximately $17.8 million in subcontractor-related expenses, approximately $7.3 million of salary and related expenses, approximately $1.4 million of materials-related expenses and approximately $2.8 million of other expenses. Total decrease in research and developments expenses was $12.2 million, or 42%, for the year ended December 31, 2023 compared to the year ended December 31, 2022. The decrease in research and development expenses resulted primarily from a $11.5 million decrease in subcontractor-related expenses in connection with the PRX-102 clinical trials, and a $0.8 million decrease in materials-related expenses.

Selling, general and administrative expenses were $15.0 million for the year ended December 31, 2023, an increase of $3.3 million, or 28%, from $11.7 million for the year ended December 31, 2022. The increase resulted primarily from an increase of approximately $2.3 million in one-time cash bonuses, share-based compensation and salary and salary-related expenses, as well as an increase of $0.3 million in travel, conferences and employee training expenses.

Financial expense, net was $1.9 million for the year ended December 31, 2023, an increase of $0.5 million, or 36%, compared to financial expenses of $1.4 million for the year ended December 31, 2022. The increase was primarily due to a decrease of $0.9 million in income related to exchange rates as well as an increase in interest expenses of $0.7 million which was partially offset by a gain recognized due to conversions of a portion of the 2024 Notes of $0.4 million and a $0.6 million increase in interest income.

For the year ended December 31, 2023, the Company recorded income taxes of approximately $0.3 million, a decrease of $0.2 million, or 40%, compared to tax expenses of $0.5 million for the year ended December 31, 2022. The income taxes resulted primarily from the provision for current taxes on income mainly derived from U.S. taxable global intangible low-taxed income (GILTI) mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act (the "TCJA"). Effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over five years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States rather than deducting such costs in the current year. The net income taxes gives effect to a valuation allowance release equal to approximately $3.1 million.

Cash, cash equivalents and short-term bank deposits were approximately $44.6 million at December 31, 2023.

Net income for the year ended December 31, 2023 was approximately $8.3 million, or $0.12 per share, basic, and $0.09 per share, diluted, compared to a net loss of $14.9 million, or $0.31 per share, basic and diluted, for the same period in 2022.

Conference Call and Webcast Information

The Company will host a conference call today, March 14, 2024 at 8:30 am EDT, 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, March 14, 2024
Time: 8:30 a.m. Eastern Daylight Time (EDT)
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Israeli Toll Free: 1-809-406-247
Conference ID: 13744193
Call me™: https://tinyurl.com/4pkhcxcj

The Call me™ 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:

The conference will be webcast live from the Company's website and will be available via the following links:

Company Link: https://protalixbiotherapeutics.gcs-web.com/events0
Webcast Link: https://tinyurl.com/mumnf9da
Conference ID: 13744193

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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