Q3 2023 Protalix BioTherapeutics Inc Earnings Call
[music].
Speaker 1: Good morning ladies and gentlemen.
Good morning, ladies and gentlemen, and welcome to the Photonics Biotherapeutics third quarter 2023 financial and business results Conference call. As a reminder, this conference call is being of the closet.
Speaker 1: Welcome to the POTALIC by a therapeutic third quarter, 2023, financial and business results conference call. As a reminder, this conference call is being recorded.
Now turn the conference over to our host Mr. Chuck Bottler of life Science Advisors Investor Relations for Photonics. If you may begin your conference.
Speaker 1: Chuck Paddala of Lifesight Advisors in the Relations for Protallics.
Thank you operator, and welcome to the <unk> Biotherapeutics third quarter 2023 financial results and business update conference call.
Speaker 2: Thank you operator and welcome to the portalics bio therapeutics third quarter 2023 financial results and business update conference.
Speaker 2: With me today are Dror Prashanth, President and CEO of Prophallix and Eyal Rubin, Senior Vice President and Chief Financial Officer.
With me today are dwarfed, Sean President and CEO for Calix, and how Y'all Rubin Senior Vice President and Chief Financial Officer.
Speaker 2: A press release announcing the results and the update was issued this morning and is available now on the Pertalix website. Please take a moment to read the disclaimer about forward looking statements in the press release.
A press release announcing the results and the update.
The update was issued this morning and is available now on the <unk> website.
Please take a moment to read the disclaimer about forward looking statements in the press release.
The earnings release and this teleconference teleconference include forward looking statements.
Speaker 2: The earnings release and this telecom, telecoms includes forward-looking state.
Speaker 2: 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.
These forward looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially.
Okay.
Speaker 2: Factors that could cause actual results to differ are described in the disclaimer and in portalix's filing with the U.S. Securities and Exchange Commission.
Factors that could cause actual results to differ are described in the disclaimer and the ports Alex's filing with the U S Securities and Exchange Commission.
Speaker 2: I will now turn the call over to Mr. Drobachan. Draw.
I will now turn the call over to Mr drove a shot dror.
Speaker 3: Thank you, Chuck. And welcome everyone to our third quarter 2023 financial results and business update call. Before we begin, I would like to take a moment to acknowledge the situation here in Israel. We at Protalix are horrified by the devastating events that have been taking place in recent...
Thank you Chuck and welcome everyone to our third quarter 2023 financial results and business update call.
<unk>, we begin I would like to take a moment to acknowledge the situation here in Israel, we are properly horrified by the devastating events that have been taken place in recent weeks.
Speaker 3: It is an extremely challenging time and we are heartbroken for the victims, families, friends and loved ones. Many of us being personally impacted.
He is an extremely challenging time and we all heard broken for the victims families friends and loved ones many of us being personally impacted.
Speaker 3: Our hearts and prayers go out to all those affected, and we remain dedicated to the safety and well-being of our people.
Our hearts and prayers go out to all those affected and we remain dedicated to the safety and wellbeing of our team. We are committed to provide all somebody's friends and colleagues.
Speaker 3: We are committed to provide our families, friends and colleagues any and all support they need.
Any and all support they need the destocking.
At the same time, we want to reassure you that we are continuing to operate as usual.
Speaker 3: We want to reassure you that we are continuing to operate as usual.
Speaker 3: There have been no disruptions to our facilities, and we do not currently anticipate any interruption to the supply of our products, Elfabri and Elilazzo. We appreciate all those who have been reached out to prosthetics to express their concern and support, and we thank you for joining us today. I will now review our recent.
There has been no disruptions to our facilities and we do not currently anticipate any interruption to the supply of our products and probably when they realize though we appreciate all of those we've reached out to provide leads to express their concern and support and we thank you for joining us today.
I will now review, our recent progress and accomplishments.
Speaker 3: Following my remarks, Eyal will provide a more detailed review of our financial results. And then, of course, we will open the line for questions. Let me now turn...
Following my remarks, John will provide a more detailed review of our financial results and then of course, we would open the line for questions.
Let me now turn to our accomplishments this quarter since receiving FDA and EMA approval in February.
Speaker 3: Since receiving FDA and EMA approval for El Fabrio, our commercial partner Kiesi has focused on commercial launch in both the United States and European Union.
Commercial partner give you had focused on commercial launch in both United States and the European Union.
Speaker 3: We are also pleased that El Fabrio has been granted additional regulatory approvals outside the EU like in Great Britain and Switzerland. And we look forward to continued global growth of El Fabrio.
We are also pleased that there's probably always been granted additional regulatory approvals outside the U like in Great Britain in Switzerland, and we look forward to continued global growth softened slightly.
Speaker 3: Having now secured the approval of two drug products, Elfabio and Elilizer, we are now focusing our attention to develop our pipeline assets with the potential to address high unmet needs for patients with limited therapeutic options.
Having secured the approval of two drugs drug products Theres, probably when they realize that we are now focusing our attention to develop our pipeline all suites with the potential to address high.
Unmet needs for patients with limited two or three quarters.
Speaker 3: Our most advanced development candidate is PRX115 for the potential treatment of severe gout. We are currently sponsoring a phase one first in human clinical trial of PRX115 to evaluate its safety, pharmacokinetics, pharmacodynamics, and immunogenicity. It is a double-blind placebo-controlled single ascending dose trial of up to 56 participants.
Most of the ones developing candidate <unk> 115 for the potential treatment of female golfer.
We are currently sponsoring a phase one first in human clinical trial of <unk>, one five to evaluate the safety pharmacokinetics pharmacodynamics anyone with Jason It is a double blind placebo controlled single ascending dose trial.
Up to 56 participants.
Speaker 3: 42 participants have been dosed to date in this first in-human trial. We expect to announce top-line result from this study in mid-2020.
42, part D C. The participants have been dosed to date.
This first in human trial, we expect to announce top line results from this study in meat 'twenty 'twenty four we believe PRA 115 is potentially a good candidate to target the smoke.
Speaker 3: We believe PR8-115 is potentially a good candidate to target this model.
Speaker 3: Our next pipeline candidate is PRX119 for the potential treatment of NETs related diseases.
Our next pipeline candidate <unk> 119 for the <unk>.
So treatment of mix related diseases net.
Speaker 3: NETs are web-like structures released by activated neutrophils that trap and kill a variety of microorganisms. Excessive formation or ineffective clearance of NETs can result in different pathological effects and has been observed in various autoimmune, inflammatory and fibrotic conditions.
Net a web like structured released biopsy vacate neutral freeze the trapped and killed in a variety of micro organisms excessive formation arena effective clearance of Mexican resulting different pathological effects and has been observed info rays ultra immune inflammatory and fibrotic conditions.
Speaker 3: We look forward to providing with updates on these programs as they progress.
We look forward to providing you with updates on these programs as they progress.
Speaker 3: There are currently several other preclinical programs and we will update regarding these programs once a...
There are currently several of other preclinical programs and we will update regarding these programs once applicable.
Speaker 3: On the corporate side, we welcome Dr. Elliott Foser as chairman of our Board of Directors, succeeding Mr. S. Bollfeld, who retired from his position on ob...
On the corporate side, we welcome Dr. Edward full serve as chairman of our board of directors, succeeding Mr has borne fruit who retired from his position on our board as an independent director of Doctor Wholesale was also appointed 12 nominating Committee.
Speaker 3: As an independent director, Dr. Foster was also appointed to our nominating committee.
Speaker 3: Elliot's reputation in management and leadership in the life science field speaks for itself. And he has a record of success in the United States, the European Union, and Asia.
Adios reputation and management and leadership in the life Science field.
Speaks for itself and.
He has a record of success in United States European Union in Asia, We are grateful to Dan for his dedication and leadership since the founding of Protonix. Many many years ago, and we look forward to working with endeavor.
Speaker 3: We are grateful to the FOE's dedication and leadership since the founding of Pratalix many, many years ago. And we look forward to working with Elliot and leveraging his expertise as we enter this exciting phase of development for this group.
Leveraging his expertise as we entered this exciting phase of development for this company before.
Speaker 3: Before turning the call to over to Ayal, I want to know that our strong balance sheet provides us with sufficient cash runway to maintain current operations without the need for near-term capital infusion.
Before turning the call over to Jan I want to know that our strong balance sheet provides us with sufficient catchweight cash runway to maintain current operations without the need for neogen copies in the future.
Speaker 3: With that, it is now my pleasure to turn the call over to Ayal to review our finances. Ayal.
With that he sees no my pleasure to turn the call over to Jan to review our financials.
Speaker 4: Thank you, George. And thank you everyone for joining today's call. Let me review our third quarter 2023 financial...
Thank you Josh and thank you everyone for joining todays call well review, our third quarter 2023 financials.
We recorded revenues from selling goods of $10 2 million. During the three months ended September 32023, an increase of one 4 million or 16% compared to revenues of $8 8 million for the three months ended September 32022.
Speaker 4: We recorded revenues from selling loads of 10.2 million during the three months and the September 30th, 2023, an increase of 1.4 million or 16% compared to revenues of 8.8 million for the three months and the September 30th, 2022.
Speaker 4: The increase resulted from early from an increase of 3 million in sales to KSZ, following the approval of the FDA and the EMA as Ro mentioned of the public.
The increase resulted primarily from an increase of $3 million incentive to kidney following the approval by the FDA and EMA as Joel mentioned the hobby.
Speaker 4: and of 0.6 million in sales to Brazil, partially offset by 2.2 million decrease in sales to Pfizer.
Point $6 million and tends to Brazil, partially offset by $2 2 million decrease in sales to fight.
We recorded revenues from licensing R&D services of <unk> 2 million for the three months ended September 30 of 2023.
Speaker 4: We quoted reviews from licensed and R&D services of 0.2 million for three months and the September 30th, 2023. And decreased of 5.2 million or 96 percent compared to reviews of 5.4 million for the three months and the September 30th, 2020.
We sold $5 2 million or <unk> 96 per cent compared to revenues of five 4 million.
For the three months ended September 32020.
Speaker 4: Remuners for licensed and R&D services are comprised primarily of revenue we recognize in connection with the QIA's A-group.
And as for licensing and R&D services are comprised primarily of revenue recognized in connection with the kids Equiavlent.
Speaker 4: As of March 1, 2020, sponsorship of the Extension Studies was transferred to Kiezi, and Kiezi is now illustrating all open-level extensions.
As of March 1st 2023 sponsorship of the extension studies was transferred to kids and kids. He's now administrating all open label extension studies.
Cost of goods sold was $4 9 million for the three months ended September 32023, a decrease of $2 2 million or 31%.
Speaker 4: Cost of goods sold was 4.9 million for the three months ended September 30th, 2023. A decrease of 2.2 million for 31%.
Speaker 4: From cost of goods sold of 7.1 million for the few months and the September 30th, 2020
From cost of goods sold of $7 1 million for the three months ended September 32022.
Speaker 4: The decreasing cost of goods sold was primarily the result of decreasing sales to Pfizer, partially offset by the increase in sales of Alfavorio to Chiesi and of El Aliso to Brazil.
The decrease in cost of goods sold was primarily the result of a decrease in sales to Pfizer, partially offset by increased concern over the fact that scares me.
And over the Liza two building.
For the three months ended September 32023, total research and development expenses were.
Speaker 4: For the few months and the September 30th, 2023, our full research and development expenses were approximately 3.7 million, comprised of approximately 1 million for subcontractor and related expenses, approximately 1.9 million of salary and related expenses, approximately 2 million of material related expenses, and approximately 0.6 million of other expenses.
Approximately $3 $7 million comprised of approximately $1 million for subcontractor related expenses, approximately $1.9 billion of salary and related expenses.
Approximately $22 million of material related expenses and approximately <unk> 6 million of other expenses.
Speaker 4: For the three months ended September 30, 2022, at all research and development expenses were approximately 7.4 million, comprised of approximately 4.9 million subcontractory-lead-in expenses.
For the three months ended September 32022, total research and development expenses were approximately $7 4 million comprised of approximately $4 9 million subcontractor you made an extension.
Approximately $1 7 million of salaries and related expenses, approximately <unk> 2 million of material related expenses and approximately <unk> 6 million of other expenses.
Speaker 4: approximately 1.7 million of salary and related expenses, approximately 2 million of material related expenses, and approximately 0.6 million of other...
Speaker 4: 12 decrease in research in development expenses were 3.7 million or 50 percent compared to 3 months and the September 30th 2020.
The decrease in research and development expenses were three 7 million or 50% instead of the three months ended September 32022.
Speaker 4: The decrease in research and development expenses primarily resulted from a completion of our FABRI clinical program and the regulatory process related to the BLA and the MAA review over the February of the applicable regulatory.
Decrease in research and development expenses, primarily resulted from the completion of all from preclinical program and the regulatory process made it to the BLA and MAA review over the property away the applicable regulatory agencies.
Speaker 4: Telling gel hours and administrative expenses were 3.7 million for the three months ended September 30th, 2023, an increase of 0.9 million or 32% compared to 2.8 million for the three months and the September 30th, 2022.
Selling general and administrative expenses were $3 17 for the three months ended September 32023, an increase of 9 million or 32% compared to $2 8 million for the three months ended September 32022.
Speaker 4: The increased result of primarily from an increase of approximately 0.6 million salary and related expenses due to one-time cash bonus and an increasing share-based compensation.
The increase resulted primarily from an increase of approximately <unk> 6 million in salary and related expenses due to one time cash bonus and an increasing share based compensation.
Speaker 4: Financial income net were $0.2 million for the three months ended September 30, 2023, compared to financial expenses net of $0.4 million for the three months ended September 30, 2022. The change resulted primarily from an increase of $0.3 million in interest.
Financial income net were <unk> 2 million for the three months ended September 32023, compared to financial expenses net of <unk> 4 million for the three months ended September 32022.
This change resulted primarily from an increase of <unk> 3 million in interest income.
Speaker 4: In the three months ended September 30, 2023, we recorded income taxes of approximately 0.1 million, which were primarily the result of the provision for current taxes in respect to Section 174 of the U.S. Tax Cuts and Jobs Act, which was enacted in December 2017.
In the three months ended September 30 of 2023, we recorded the income taxes of approximately $21 million, which were primarily the result of the provision for current taxes irrespective section 174 in the U S tax cuts.
And jobs Act, which was enacted in December 2017.
Speaker 4: Caching, cash engines and short-term bank deposits were approximately $41 million at 10 minute 30st by 20 cloud homes.
Cash and cash equivalents and short term bank deposits were approximately $41 million timber 30 of 2022.
Net loss for the three months ended September 32023 was approximately $1 9 million or 0.0 $3 per share basic and 0.0 $4 per share diluted compared to a net loss of $3 6 million or $7 per share basic and diluted for the same periods in 2022.
Speaker 4: NELOS for the 3 months and the September 30th, 2023 was approximately 1.9 million or 0.03 dollars per share, basic and 0.04 dollars per share, they needed compared to NELOS of 3.6 million or 0.7 dollars to share basic and they needed for the same period in 2022.
I will now turn the call back to Dror.
Speaker 3: Thank you, Ayal. In concluding this earnings call, I would like to know that we are pro-Talics are proud of our accomplishments. We have a proven platform technology. We have two approved therapeutics driving a region, sustainable pipeline of us.
Thank you Ian.
Concluding these earnings call I would like to know that weird photonics, all proud of our accomplishments we have a proven platform technology with two approved therapeutics driving to reach a sustainable pipeline of Boston.
Speaker 3: A world-class team, a strong balance sheet supporting our strategic planes, and a strategic vision to creating a long-term value for our stockholders. We look forward to updating you in the future on our program.
Class team, a strong balance sheet supporting those strategic plans and our strategic vision to creating long term value for stockholders. We look forward to updating you in the future on our progress before we start taking questions I would I would like to note.
Speaker 3: Before we start taking questions, I would like to know...
Speaker 3: that we are praying for our friends and family, during this charging time. One that is filled with pain. I'm grateful for our entire Potalic team. They're enduring commitment and resolve at this time as we develop a portfolio for patients with unmet medical needs is not worth.
That will frame for friends and family families. During these challenging times, one that is filled with pain.
I'm grateful for all entitled Photonics team their enduring commitment and resolve of Destocking as we develop a portfolio for patients with unmet medical needs is noteworthy.
Speaker 3: Now I would like to ask the operator to open the call for questions please.
Now I would like to ask to ask the operator to open the call for questions. Please.
Speaker 1: Thank you. We will now be conducting a question and answer session.
Thank you.
He will now be conducting a question and answer session.
If you would like to ask a question. Please press star one on your telephone keypad.
Speaker 5: If you would like to ask a question, please press star 1 on your telephone.
Speaker 5: A confirmation tone will indicate your line is in the question.
A confirmation tone will indicate your line is in the question queue.
Speaker 5: You may press star 2 if you would like to remove your questions from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
I stopped to if you would like to remove your questions from the queue.
Lots of things using speaker equipment, it may be necessary to pick up your handset before pressing the stock each one.
One moment please poll for questions.
The first question comes from the line of.
Well Balan.
But etsy being placed please go ahead.
Speaker 6: Hi, this is Bhubalan. Sorry for the voice. I'm still recovering from sore throat. So thanks for taking our questions. Firstly, with respect to revenue from selling goods, I see that the revenue dropped from 15 million in second quarter to 10 million in the third quarter. Can you discuss the underlying factors for this drop in revenue? And also, what are your expectations for revenue in the fourth quarter?
Hi, This is Bob Allen I'm, sorry for the Y sand cintra coloring from salt drought. So thanks for taking our questions firstly with respect to revenue from selling goods.
So I'd say that the revenue dropped from 15 million in second quarter to 10 million in the third quarter. So can you discuss the underlying factor for this drop in revenue and also what are your expectations for revenue.
For the fourth quarter.
Speaker 4: Thank you, Bovalan, for the question. So in terms of the decrease, part of the decrease is decrease in sales to Pfizer, and part of it is decrease in sales to KSV. As I mentioned in the previous call, the sales to KSV are basically their inventory buildup. At this point, the sales to KSV are not indicative of the penetration of sales in the market. So obviously, as they build their inventory, there's going to be fluctuation in the next year and a half, or even two.
Thank you for that answer the question so in terms of the decrease.
Part of the decrease is decrease in sales to Pfizer and part of it is decreasing sales two P. M D. As I mentioned in the previous call.
The sales the kids they are basically the inventory buildup. This fall in the sale of two kids are not indicative of the penetration of sales in the market. So obviously as they build inventory was going to be fluctuation in the next year and a half or even two.
Speaker 4: During the term that they're building the inventory and so you were truly also penetrating the market and building the peasant
Hey, yeah during the terms that they're building the inventory and slowly materially also penetrating the market and building the presence in the markets.
Speaker 4: Yeah, with respect to the second question about guidance on the revenue for the fourth quarter, we usually don't provide guidance for revenue, especially.
Yeah with respect to your second question about the guidance on the revenue for the fourth quarter, we usually don't provide guidance where revenue, especially <unk>.
Speaker 4: since the P.O.s from Q.A.Z. and from Brazil and China are dynamic, especially at this point, where Q.A.Z. is the majority of the sales and they are building up their presence in the market. So I guess that it's gonna take time till we'll be able to share forecasts and so comfortable giving those forwarding takes.
Since they are you know the.
He owns from kids, he and from Brazil and size, our dynamic, especially at this point.
The majority of the sales and they are building up the there their presence in the market. So I get that it's going to take time to be able to share forecast I'm still comfortable.
Given those forward looking statements.
Okay Fair enough and then congrats on meeting FDA regulatory approval in UK and Switzerland. So I was wondering if you could provide or maybe are the high level discuss.
Speaker 6: Okay, fair enough. And then, congrats on meeting FDA, sorry, the regulatory approval in UK and Switzerland. So, I was wondering if you could provide or maybe at a high level, discuss the poverty-disease market opportunity in the UK and Switzerland. And also, which countries can we expect to approve El Fabrio in the upcoming quarter?
Ravi this is market opportunity in the UK and Switzerland, and also about which countries can we expect a pill approval if I build in the upcoming quarter.
Okay.
Speaker 3: So, actually, you know, the drug was approved already in most of the, if I may say,
So actually even though the drug was approved they already in most of the if I can say.
Speaker 3: Western country in Europe , so you know the United Kingdom is not part of the EU but it's certainly an important market.
Western country in Europe. So you know the United Kingdom is not part of the EU, but it's certainly an important market.
Speaker 3: And also in Switzerland it was approved. And the idea is indeed to move on to other markets outside the EU, including Japan, where KFZ initiated the deal.
And also in Switzerland, and it was approved.
Idea is indeed to move on to other markets outside the U include engage upon will gives you initiated the.
Speaker 3: study in order to register the drug later on and in other markets as well. As for the...
The study in order to register the drug later on.
In other markets as well as well as for the.
The specific size of the fabry market in the U K I don't have it in front of me and also this is a you know kids these and if I may say, yes.
Speaker 3: specific size of the fabric market in the UK. I don't have it in front of me. And also, this is, you know, Kiez's, if I may say,
Speaker 3: Role right now. So once we will have more data or case you will release more data. We will be able to share it
All right now so once we will have more that all kids you will release more data, we we'd be able to share it with you.
Speaker 3: But it's, but certainly the UK is a very important market in the, in Europe .
But it's but.
Certainly the U K the he's a very important market indeed.
Let's put it this way.
Yes.
Okay. Thanks for the color, let's switch gears and discuss our clinical programs, especially parex one on file.
Speaker 6: Okay, thanks for the color. Let's switch gears and discuss your clinical programs, especially PRX-1 on 5, the ongoing Facebook study. So I'd like to get some additional color on some of the items that you listed in the exclusion criteria. So I was looking at the clinicaltrials.gov.
The ongoing phase one study so I'd like to get some additional color on some of the items that you listed in the exclusion criteria. So I was looking at the clinical trials that go lets say.
And some of that.
Speaker 6: and some of the criteria, especially the students criteria.
Criteria, especially the exclusion criteria.
Speaker 6: So it says you're excluding patients with one or more gout flare in the last one year and those with subcutaneous DOFI or those with advanced renal diseases, they're also excluded. So I'm trying to understand is the strategy to target mild or moderate
So it says you're exploring patients with one or more gout flare the last one year and those with subcutaneous dose fie are those that are advanced renal diseases.
I'm trying to understand is the strategy to target my.
Eldar moderate forms of college.
Speaker 6: without the brain or complication if I may. So you can clarify more on.
Without complication.
If I may so you can try to find more of them.
Speaker 3: Yes, sure, thank you for that. So actually, you know, it's a phase one study. It's a single dose, so it's the first time we actually infuse it to participants. The participants are actually volunteers with hyperuricemia. And the idea is first to check safety.
Yes sure. Thank you for that so they actually you know what you said.
One study is a single dose so it's the first time, we actually infuse it too.
Two participants the participants I actually when it deals with hyper you receive your they'll not so.
And the idea is first to check safety of course, and then to see if indeed, we reduced the hyper you'll receive me onto a normal levers all acceptable levels and then take it throws out so we measure multiple aspects in order to be able to move on of course subject to safety.
Speaker 3: and then to see if indeed we reduce the hyperuricemia to normal levels or acceptable levels and then take it further. So we measure multiple aspects in order to be able to move on, of course subject to safety, to a multiple ascending dose later on in 2024.
To a multiple to like him and multiple ascending dose later on in 2024.
So it does not indicate right now.
Speaker 3: So it does not indicate right now the idea is not to indicate for mild patients at all, actually it for severe gut patients.
Idea as Milton indicated for my patients at all extra leads for severe adult patients.
Okay. Thank you for the color one last question if I may so again with respect to our PR excellent on five.
Speaker 7: Okay, thank you for the color. One last question if I may. So again, with respect to PIR X1 on 5, I know you're collecting immunogenicity data and blood uric acid levels as well. So I'm curious like, what do you expect to see in these two data, especially is phase one study? What are your expectations? So again, we would...
So I know youre collecting you mean like Genesis data and black uric acid levels I thought so I'm curious like what are your what do you expect to see you know they still data, especially it's a phase one study well what are your expectations.
So again, we would like to see.
Safety for sure and then we will analyze for me PK P D point of view.
Speaker 3: safety for sure. And then we will analyze from a PKPD point of view, you know, additional measurements to see if we have in indications for reduction of cause of the hyper-yorecymia and other parameters in order, again, to see frequency of those in and other signals that will enable us, if I may say, to take further steps or more calculated steps for the next study.
Yeah, you know additional measurements to see if we're having in indications for reduction of causal the hypoglycemia and other parameters in order again to see frequency of dosing.
Yeah.
In other signals that we enable us if I may say to take you know fill those six or more calculated steps for the next study.
Speaker 3: Okay, thank you for taking all my questions. Yes, and again, just to make sure we, the intent at least is to enroll up to 56 subjects. So I think it's enough of a number to, we hope it's enough of a number to get enough information to move on, you know.
Okay. Thank you for taking all my questions and again just to make sure. We the intended leases to enroll up to 56 subjects. So.
I think it's enough of a novel too.
We hope it's enough of and number two to get enough information to move on.
You know I.
Speaker 3: I won't they minimize the risk, but you know, with less risk of course.
I wouldn't say minimize the reasonable you know.
With less risk of course say.
Safety for sure, but more than that.
Speaker 5: Thank you. Next question comes from the line of John van der Mosten with Zax. Please go ahead.
Thank you.
Next question comes from the line of Jon Vander, Boston, but sacks. Please go ahead.
Alright, Thank you and George Yeah, I'll get back in the queue.
Oh beyond Paul how much of your expense structure is oriented towards that.
Speaker 8: Beyond Paul's, how much of your expense structure is oriented towards the alfabria business model?
Yeah.
Okay can you repeat the question I can hardly hear you I'm sorry.
Speaker 8: I'm sorry. The oncologist, how much of your expense structure is oriented towards the outfabricated?
I'm sorry, the encore how much of your expense structure is oriented towards the battery.
Yeah.
Speaker 4: There are the interiors of cross structure, other than the manufacture.
And then in terms of cost structure other than in a section.
Speaker 4: which takes something like three to four months a year. And the production of three to four months a year is sufficient to supply and provide half of the patient population worldwide. We're not investing at present in alfabric.
Which takes a something like a three to four months of the year.
And the production on three to four months a year is sufficient to supply.
Supply and provide half of the patient population worldwide.
We're not investing at present.
Pardon me.
Okay.
Speaker 8: And how do you see your capital structure changing now that you have two revenue generating products and then also, you know, keeping in mind that is the convertible that on the on the balance sheet.
And how do you see your capital structure changing now that you have two revenue generating products and then also you know keeping in mind the.
Convertible debt.
Debt on the balance sheet.
Yeah.
Speaker 4: That's a good question. A, that's true that we have two J, you know, we're having a generic, thinking product out there. And since we are not doing anything in the equity capital markets, so obviously I guess it's gradually slowly, but truly, revenue is gonna sput the wind up.
That's a good question, Hey, that's really weird to Jay.
In January to getting product out there.
Since we are not doing anything in the equity capital markets, obviously, I guess gradually slowly but surely.
Revenues are going to start to ramp up.
Speaker 4: The big boys are going to join the party and we're going to see that we have the stable stream line of revenues and we are accumulating cash.
The Big boys, they're going to join the party and you're going to see that we have the stable streamline of revenues and we're accumulating cash.
Speaker 4: And so it's a different company. It's not a biotech, a typical biotech company in the development stage. At present, we don't see this change. As we said, the company at this point is still sustained. We don't see any need to raise money in the foreseeable future for the ongoing operations. So I guess that's going to take time. What we're talking about is that the capital should be...
So it's a different company not a a you know a biotech typical.
Biotech company in the development stage.
At present, we don't see this change.
As we said the company at this point, it's still something we don't see any need to.
To raise money in the foreseeable future. So the ongoing operations, so I get that.
That's that's going to take time, all the time I get that.
Capital structure is going to change.
Speaker 8: Okay, and I think they're coming to do next year in the body.
Okay.
I think they are coming due next year next year.
Speaker 8: And then, quarterly cash flow, can you give us some help on how to forecast that going forward? I noticed it was a little bit greater than net income for the quarter, and I just wanted to see if you could help us understand how that might flow through for the next several quarters.
And then quarterly cash burn.
Can you give us some help on how to forecast that going forward I noticed there was a.
A little bit greater than net income for the quarter and I just wanted to see if you could help us understand how that might flow through the next several quarters.
Speaker 4: Yeah, so I think that I responded to this one previously to Google on. Things were just the end of the revenue ramp up and kids just starting to penetrate the market and building the president. So, but surely I guess that they, that's going to fluctuate. So, you will only come to this point sharing the forecast for the next couple of quarters.
Yeah. So I think that they are responding to this one previously to be built.
And it seems we're just the NFA the revenue ramp up in kids, they're just starting to penetrate the market.
Building the presence and.
Sony, but surely I guess that.
That's going to fluctuate. So you don't feel comfortable at this point sharing do you forecast for the next couple of quarters.
Speaker 4: I think it's very, very, very, very, very fluctuative. I can decide that they are pulling two batches, one batch for even technical reason, you know, delaying one. So I think I think at this point, it would be responsible to share targets for the short term. Long term, as I said in the next day, you're gonna have to, that's gonna be mostly an inventory build up.
So it's a very very very fluctuating.
They can decide that they are they're pulling two batches one batch.
For technical reason delaying one.
So I think yeah, I think at this point wouldn't be responsible to share yet for gets for them for the short term long term as I said in the next day, you're going to have to yes, that's gonna be mostly an inventory buildup.
Speaker 4: a run rate that will ramp up, I'm talking about sales.
With a run rate that will ramp up probably about sales obviously.
Speaker 9: We ramp over over, you know, over time.
It will ramp over or you know overtime.
Speaker 8: Okay. And then shifting to a Fiora X115 and assuming that top line comes out as expected, they're better in the middle of next year. What is an excess there? Would that be a phase two or, I guess I'm just wondering what we should expect to see from that development program?
Okay.
And then shifting to a pure X 115, and assuming that the top line comes out as expected or better.
In the middle of next year, what what are the next steps there would that would it be a phase two or.
I guess I'm just wondering what we should expect to see from that development program.
Speaker 3: So we intend to do a multiple...
So we intend to do it multiple.
Yeah.
Does the following the single dose that we do know and then you'll know once we ever which means.
Speaker 3: dose following the single dose that we do now and then you know once we have which is actually a phase two and then we will continue from there
Extra of your phase III.
And then we will continue from there.
Okay.
Speaker 10: Okay. And just one last one on 119. What are the next steps for that program?
Just one last one on the 119.
What what what are the next steps for that program.
Speaker 11: So we thank you for that. So we will gather information in the near future, if I may say from the different preclinical studies and other data that we have. And we'll go for, if I may say, kind of a protocol, no go meeting. And if indeed we decide to go ahead, we will share and continue to toxicology and phase one.
So we right now.
And thank you for that so we will go there.
The information in the next.
And then if you were to if I may say from the different preclinical studies in other doctors that we have and we'd go for.
I think I know for Paul toward a go no go with meeting and if indeed, we decided to go ahead to where we were sharing and continue.
The toxicology in phase one.
Okay I appreciate it thank you.
Thank you.
This concludes today's question and answer session I would now like to come to floor over to dwell question for closing comments.
Speaker 3: So thank you. So thank you everybody for your participation. And I appreciate the time. And we look forward to picking with you on our next call for 2023 results. And I hope with a...
Thank you.
So thank you everybody for your participation.
And I appreciate the time and we look forward to speaking with you. All know next scornful 2023 results and I hope with ER.
A more peaceful time for us here in Israel. Thank you all.
Speaker 5: Thank you. This concludes today's teleconference. You might disconnect your lines at this time. Thank you for it.
Thank you. This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.
Thank you.
Speaker 12: Thank you.
Yeah.
Uh huh.
[music].
Yeah.
Sure.
[music].
Yeah.
Yes.
Yeah.
Uh huh.
Okay.
Yeah.
Okay.
Yeah.
[music].