Q4 2022 Protalix Biotherapeutics Inc Earnings Call
Good morning, ladies and gentlemen, welcome to the probiotic food year 2022 earnings call.
Minder This conference being recorded I would now turn the conference over to your host Monique coffee of lifestyle adviser Investor Relations for <unk>. Thank you you may begin.
Thank you operator, and welcome to the Metallics <unk> Therapeutics fiscal year 2022 financial results and business update conference call.
With me today, or tomorrow, Vishal, President and CEO for Calix.
I'll 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 Calix website.
Take a moment to read the disclaimer about forward looking statements in the press release.
The earnings release and this teleconference includes 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 input Alex's filings with the U S Securities and Exchange Commission.
I will now turn the call over to Mr. Jarvis shot.
Sure.
Thank you Monique and welcome everyone to our fiscal year 2022 financial results and business update call.
I will begin by reviewing our progress and accomplishments over the last over the past year.
Along with our plans for the coming months following my remarks.
We'll provide a more detailed review of our financial results.
And we will then open the line for questions.
So 2022 was a strong year for botox and over the last year, we made significant progress on multiple fronts I would like to begin by highlighting the most recent achievements together with all development and commercialization path of TLC global root diseases.
We are pleased very pleased that the European Medicine Agency committee for medicinal products for human use or <unk> <unk>.
<unk> positive opinion and recommended marketing authorization of <unk> 102 for the treatment of adults with fabry disease.
This is a significant step towards the potential approval of PRA, its one or two in Europe and brings us closer to delivering reached treatment option to fabry patients around the world.
The final decision is now referred to the European Commission, which is expected to provide a decision marketing authorization in early may of this year.
Not only we are approaching potential approval in Europe , but we also look forward to potential approval in the United States as previously announced the U S. FDA accepted our resubmit the biologic license application for <unk> for review in December .
It was resubmitted already in November <unk>.
These we receive this acknowledgment acknowledgment letter on December 9th in our assigned a <unk> target action date of May nine 2023 and is quickly approaching.
Yes.
Including in these regulatory submission to the EMA and FDA with a comprehensive results from our phase III clinical program as well as long term data from our ongoing open label extension studies final results from our phase III bright imbalance drives were completed and announced earlier this year and both studies met their it.
Respective efficacy on safety objectives.
This robust set of data represents hundreds of years of patient exposure to periods, one or two and we believe provides a compelling case to the regulators to consider these important potential treatment option.
Four it does affected by Fabry disease.
We look forward to providing you with updates as we approach potential approval in the EU and the U S. If approved Pra's, one or two will be a second approved drug from all proposed the protein expression system called prosthetics, providing even further validation of this unique and innovative platform.
As we enter into what we would be an exciting year for photonics, we would like to.
To reiterate our appreciation for his partnership and dedication to this program and we think both proteomics and <unk> teams for all their efforts to deliver this potential new treatment to patients with fabry disease.
Turning to our early stage pipeline and we are continuing to develop promising candidates expressed dwell prosthetics protein expression system.
<unk> is a novel Pegylated Youll recall in development for the treatment of severe gout final results from the first stage of one months multiple dosing.
[noise] toxicity studies.
<unk> hundred 16 in two species to support the phase one study showed no indication of safety concerns.
Our current development plan goal is to initiate a phase one clinical trial in the next couple of weeks.
In addition, we continue to make progress on Prs, one nine a pegylated recombinant human DNA was one protein design to elongate the half life in circulation for the treatment of <unk>.
<unk> related diseases.
We have conducted preclinical studies to demonstrate the feasibility of periods 119, and we look forward to providing updates on this program as well.
Throughout this year.
Finally, our balance sheet provides us with sufficient cash runway through the first quarter of 2020 for supporting the company.
The potential improvement in addition to continuing developing our early stage pipeline programs as I mentioned.
Now before I turn to you all.
For a review of our financials.
I would like to say that with regard to the process filed earlier. This morning, I asked to clarify that the principal side with connection to the ATM program in the company I have to emphasize this is not an announcement of a fundraising.
Now I'll turn to IL IL. Please.
Thank you Dror and funds.
One for joining.
The information I'll review our two.
2022 financials.
The company recorded revenues from selling goods of $25 3 million for the year ended December 31, 2022, an increase of $8 6 million or 61% compared to revenues of $16 7 million for the year ended December 31 2021.
The increase resulted from an increase of $2 2 million in sales to Pfizer and increase of $3 1 million in sales to Brazil, and an increase of $3 3 million in sales to key.
Revenue from license and R&D services for the year ended December 31 2022.
Were $22 3 million, an increase of <unk> 7 million or 3% compared to revenues of $21 6 million for the year ended December 31 2021.
Revenue from license and R&D services represent mainly the revenues we recognized in connection with the TSA agreements.
Cost of goods sold for the year ended December 31, 2022 was $19 6 million, an increase of $3 3 million or 20% compared to the cost of goods sold of $16 3 million for the year ended December 31 2021.
The increasing in cost of goods sold was primarily the result of an increase in sales of goods.
Total research and development expenses for the year ended December 31st 2022 were approximately $29 3 million comprised of approximately $17 8 million in subcontractor related expenses approximately.
Approximately seven $3 million of salary and related expenses.
Approximately $1 4 million of material related expenses and approximately $2 8 million of other expenses.
For the year ended December 31, 2021, our total research and development expenses were approximately $29 $7 million comprised of approximately $18 $4 million in subcontractor related expenses.
Nearly seven $4 million of salary and related expenses, approximately $1 2 million of material related expenses and approximately $2 7 million of other expenses.
Increase in research and development expenses of $4 million or 1% for the year ended December 31, 2022 compared to the year ended December 31st 2021 resulted primarily from <unk> 6 million decrease in subcontractor related expenses in connection with our pure X one or two clinical trials.
Can you offset by point 2 million increase in materials related expenses.
Selling general and administrative expenses were $11 7 million for the year ended December 31st 2022, a decrease of $1 million or 8% from $12 7 million for the year ended December 31, 2021. The decrease resulted primarily from a decrease in professional fees and salary related expenses.
Casualty expenses net was $1 4 million for the year ended December 31st 2022, a decrease of $5 7 million or 80% compared to financial expenses.
Seven 1 million for the year ended December 31st 2021.
Increase resulted primarily or interest debt amortization costs.
The decrease in our outstanding aggregate principal amount of it.
$92 million or.
22.
So in aggregate principal amount of $28 $75 million of 2024 notes.
An increase in exchange rate of news are in shekel for U S dollars over the periods.
For the year ended December 31st 2022, we recorded income taxes of approximately $530000 we.
We didnt record income taxes for the year ended December 31st 2021. The income taxes were recorded for 2022 and certain section regarding deductibility of research and development expenses of the U S tax cuts and jobs Act of 2017 went into effect on January 1st 2022.
Cash cash equivalents and short term bank deposits were approximately $22 2 million as of December 31st 2022, I will now turn the call back to you Dror.
Thank you.
Thank you everyone for joining us on today's call. We are excited for the year ahead.
As we await potential approval of <unk> for adult patients with Fabry disease, and we continue to work towards our mission of delivering new medicines to patients with high unmet needs.
Now I will turn the call back to the operator to open the line for questions. Please.
Thank you we will now conduct a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Permission tone will indicate your line is in the question queue you May press.
Our two if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the snarky once again Thats star one to ask a question at this time one moment, while we profile first question.
Our first question comes from <unk>, <unk> and <unk>.
Wainwright. Please proceed.
Hi can you hear me okay.
Yes, Sir.
Alright, great Congrats on the progress and few questions from our end. So many kids it makes launch decision for <unk>, but from your perspective.
How early could rugby launched in order for you our shareholders.
Some of that.
Okay.
So firstly thank you for the question, though this is a question to kenzie.
As far as we understand once we get approved there will be.
A couple of months I assume.
To finalize reimbursement schemes or programs with the relevant insurers in the different <unk>.
Countries in Europe and of course in call It I hope.
And then it will be.
Would it be valid commercially.
But again this is a good question too crazy, but I assume this is the plan.
Okay.
In your view, what's the general physician ever Nashville, BRL, one two in the European Union.
Okay can you repeat the question I could not understand it I'm sorry.
I'm trying to understand the general physician awareness of Parex 102 in European Union.
So thank you I think there is a high awareness.
This program is.
If I may say.
So the clinical program is eight nine years old and the program itself is even earlier.
We work with.
<unk>.
First the gateways and physicians throughout the World we had.
Clinical sites, both in Europe , and in the U S as well as Australia and other places so as time goes by and when we mentioned in a couple of times that we have one hundreds of years of patients accumulated exposure.
Clearly a significant portion is also in Europe . So I hope this answers your question.
Okay clear.
Can you can you frame fabry disease market opportunity in the European Union and can you discuss any progress or any gating steps to securing reimbursement in European Union.
So I know the <unk>.
Program first again this is a question to <unk>.
The indication is about.
Between two $2 $1 billion very wise.
It grows.
Globally.
I hope that and we believe that for care as we know it will be a very high priority and I'm sure that will apply.
You know the best effort on the commercial program.
And then we'd have to position this drug well.
And thats it for specific details with regard to their.
Reimbursement efforts I suggest you will ask it directly.
Okay.
And then switching gears thinking about EUR 115 Gulf program.
Then last call you mentioned that they will be submitted in the first quarter. So can you clarify the IMD has already been submitted and you are ready to launch phase one.
So we are ready to launch phase one the phase one will be conducted outside the U S.
In the center of Excellence in New Zealand.
I assume that once it hopefully.
We will.
Finalize the phase one successfully.
We will prepare Meanwhile, and we will discuss also with FDA recently global Phase II one day.
Next steps.
Okay.
So it does speak to one once again, how many healthy volunteers or patients I'm not sure, which one you are going to.
We are going to target, but how many initial data set patients you need in order to move forward.
To get closer to the proof of concept studies.
Yeah.
But what we are planning at all is the first in human Phase one study.
And we will publish everything once we publish the protocol. So we you will see all the details.
Yeah.
Okay, and maybe one final question, how long do you expect to run the phase <unk> study.
And maybe when you're ideally, we'd like to see the data.
Yeah.
We study I'm, sorry, I could not understand.
So I'm just curious how long do you expect to run one on 115.
So we expect to run it until.
At the end of this year.
So I hope, we will be able to finalize the CSR by the beginning of next year.
Great. Thanks, so much for taking my questions of course.
Once again, ladies and gentlemen to ask a question. Please press <unk>.
One on your telephone keypad.
Our next question comes from John's been there most of them, but Sir Please proceed.
Thank you and good afternoon Dror anyhow.
Let me start out with a question on just milestones that we expect after Meg is supposed to be a big months with both EMA and FDA I expected, but after that what should we look for on the horizon in terms of milestones for.
For the company.
Yes. Please.
I think Jon you're referring clinical EMR right not financial ones.
Oh, well just any any major events I mean, you had the other two programs, which drove I talked about this a little bit on 'twenty. One five in terms of that phase one, but just anything else, we should keep an eye out for.
On the horizon.
Not at this point as Jordan mentioned, we are.
So our first in human next couple of weeks on the periods 2015.
And then finish it by the end of this year.
Possibly potentially we're going to be with.
Early next year the first.
Yeah main major milestones that we can foresee.
The current package.
Okay. Thank you al and.
In terms of the financial cash flows and everything thats related to.
<unk>.
102.
When do we expect assuming that sales are made in the second quarter or even the third quarter when might those cash flows be recognized are received and when might they be recognized on the financial statements.
Hello.
Section with the.
Approvals.
We received within 60 days.
And.
Obviously, they're going to be recorded.
We get them from from.
Well the street, they along with the financials.
Okay, very good and IC.
I saw that you mentioned in the K and we've talked about this before but you mentioned the case. This time that the <unk> is no longer has a specific EU and a lifestyle is marketed globally. What does this mean for future revenues.
Same for <unk>.
So since we don't the commercialized analyzer.
Market and commercialized by Pfizer.
Alright, whether to start marketing in Europe .
Ah.
Alright, serving them.
Okay.
Based on the deals we received from them.
Yeah, they'll have to rethink internally.
Wanted to penetrate.
We're calling it the EU.
At the end of the day, it's a market by market.
They have struggled so they'll have.
We will be.
Sure.
Okay, great and I assume that you have regular conversations with them on kind of how things are going with the product sales.
You guys, obviously have to plan production and everything like that so I assume that you have conversations with them right.
Yes, that's correct.
Question for David.
The commercial rights.
Got it got it.
Last one from me is also saw that you your agreement with GAC for fill finish activities and just was wondering what the geographic location of that since youre going to be producing.
Drug product in Israel, and then I guess, where is it going to be shipped for the further disposition.
And it's going to be shipped to parmer.
<unk> pharma.
Yeah.
<unk> delivered.
Yeah.
Great Alright, well. Thank you yair, Thank you dror, our pleasure to speak with you.
Thank you Jim.
Thank you at this time I would like to turn the floor back over to management for closing comments.
So I have to thank everybody very much for your time today.
We are really happy with the recommendation.
This can be.
And we look forward to providing you with further good news down the road. Thank you very much have a nicely.
Thank you. This does conclude today's teleconference. You may disconnect. Your lines at this time and thank you for your participation and have a great day.
Thank you.
Okay.
Okay.