Q1 2020 Protalix Biotherapeutics Inc Earnings Call

Greetings.

First quarter.

Hi.

At this time.

[music].

Operator.

Please press star.

This conference is.

Sure.

Oh.

<unk>.

He said.

Thank you operator, Hello, everyone and welcome to pellets Bio Therapeutics first quarter 2024, Naturals Hilton business update conference call with me today, Mr., <unk>, President and CEO, Metallic's and ill Rubin Senior Vice President and Chief Financial Officer.

A press release announcing results and the uptake is available for Calix website.

Please take a moment to read the disclaimer about forward looking statements in the press release.

Earnings release, and there and this teleconference include forward looking statements.

These forward looking statements are subject to known and unknown risks and uncertainties that may cause.

It may cause actual results could differ materially from the statements made factors that could cause actual results to differ are described in the disclaimer and in our filings with the U.S.

Securities Exchange Commission.

Now turn the call over to Mr. draw the sharp.

Thank you good morning, and think it will join US today to review the company's first quarter Twentytwenty operations in recent highlights during this call will provide an update on all cleanly Cardin corporate progress and then I would ask I'll see if all the other will be to review the Companys financial results before opening the lines for questions.

The first of all those Twentytwenty is being sold in the transformation I was hoping colleagues. Despite the coffee 19, Pandemics that's affected global markets I'm proud to say that despite the pandemic for thought it was able to keep the company running smoothly and adapt quickly.

To that changing environment.

It's been anticipated last week dogs to get it was all development and commercialization bought two kids eat global <unk> disease the unique.

The mother company Kids eat submitted the biological license application to the U.S. 58, Sofia rigs one is too.

Hey via the FDIC accelerated approval pathway.

Right. So I don't know tools granted fast track designation by the FDA in January 2018.

Yeah. They submission includes a comprehensive set of preclinical and clinical and manufacturing data compiled from all completed phase one two clinical flight spirits, one or two including the related extension studies exceeding the phase one two clinical trial spirits, one or two.

Entering clinical data from all phase three breach switch over study is weighted safety data from our ongoing clinical studies will be our rigs one or two including extension studies.

On the B. I know your full one if approved provides would be eligible to receive milestone payments from Q.

It was really Maui in May we have announced open Oh positive topline results from the completion of the phase three breach clinical trials Prs one or two these open label switch over study met its main objective for safety and the secrecy and indicate this substantial improvement in renal function in patients switched from Brooklyn, I've got to be I was wondering.

[noise] imports. This important it's called east confirms our belief that be Rx rental tool can be an important <unk> enzyme replacement therapy, and the new treatment option for fabry disease.

To give that we sold two ongoing fully enrolling phase three clinical trials the bonds in the bright studies. We believe we have the most comprehensive comprehensive in a robust phase three clinical programs. So fabry disease. Currently enforce Additionally in February of this year, we have announced together was also developing in commercialization partner.

Good lead.

And there was heats up an agreement let alone the FDIC before they need to drink study Planful Prs one do outlining an agreed upon approach to address the needs of the dramatic fabry patients is way.

Well now sixteens up this year, we have announced an agreement to conduct feasibility study, we skewing holdings company to evaluate the production will fund noble complex brought on using prosthetics.

And the company receiving nonrefundable payment of 1 billion dollar and Cameron has agreed to provide research funding for Platonic scientists to conduct Sedline engineering and protein expression studies on the dog and Pony.

We'll now turn over the call to a young our CFO to review all financials.

Thank you George and thank you everyone for joining today's cool.

So as we previously announced in March for data center it into securities purchase agreement with certain existing and new institutional.

And all their E S accredited investors in a private placement in connection with the private placement, we issued approximately 17.6 lean unregistered shares or common stock at a purchase price of 2.4 or $5 per share and warrants to purchase an additional approximately 17.6 million shares of common stock.

It's an exercise price of 2.3 $6 per share in exchange for getting that committed proceeds equals to approximately $41.3 million net proceeds from the financing are being used to advance our clinical program.

And commercialization of pure it's one of them too for the treatment of fabry disease as well as to further develop or early stage pipeline of therapeutics and for general corporate purposes.

And now for the numbers for the three months ending March 31st 2020, cutouts recorded revenues from selling goods a $5 million.

An increase of 1.5 million were 43% compared to revenues of 3.5 million for the same period of 2019.

The increase is older primarily from an increase of 1.8 million since drug product to Brazil, as one of the increased $1.7 million in sales or drug substance to fight.

Revenue from licensing E and research and development for three months ended March 31st 2020 were 616.6 million increase of 9.7 million, 440% compared to revenues of 6.9 million for the same period those 2019.

The revenues from license eight agreements represent a revenues Rick recognized in connection with the previously announced agreement when kids.

Cost of goods sold was three point Fourmillion for the three months ended March 31st 2020, an increase of 1.4 million or 68% from the color was sold off 2 million for the same period all 2019.

R&D expenses were 10.3 million for a few months ended March 31st 2020 decreased a 1.4 million for 12% compared to 11.7 million of R&D expenses for the same period all the 2090.

As you any expenses were 3.2 million for the three months ended March 31st 2020, an increase a million dollars, 43% compared to 2.2 million for the same period of 2019.

And finally net income for the year three month ended March 31st when it when he was roughly 7 million war profit of 10 cents per share basic and diluted compared to a net loss of seven point threemillion or point.

$5.50 per share basic and diluted loss for the same period of 2019 and now I'll turn the call back to you George. Thank you are ya during the last quarter, we were able to close to 43.7 million private placement. Furthermore, the topline results from a phase III breached study and the subsequent.

Really submission recently for pediatric swung to which we are announcing may show different techniques is actually gained momentum by linking by leaning into an precedent challenge.

[noise] I'm convinced now more than ever that our team is positioned for long term success and look forward to continuing on momentum through the rest of this year in into 2021 into my team and to our many investors partners and colleagues I think you any appreciate these are.

With that I will now turn the call back to the operator, we'll open the call for questions from the audience.

Thank you we will not be conducting any question and answers fashion. If he would like to ask a question. Please press star one on your telephone keypad.

Information from the indicate that your line is my question Q you made fresh start to if you were like your move your question from the Q.

Participants using speaker equipment and baby necessary to pick up your handset before pressing the star teens.

Our first question comes from the line of Ron So for watching what H.C. Wainwright. Please proceed with your question.

Hi, This is bollen dialing in for wrong for Roger Thanks for taking my question.

It's one how long is it likely to fix what do you have today to render a decision on whether or not.

Really far P. Rx ones, they don't do for reveal.

[noise], so I'm, sorry, but I do not understand the question we have submitted the fund the wheel waiting for there to be side or on the PDUFA date.

So yeah I'm sure I'm, just wondering how long would it take note of doing or hear from Oh.

Oh, I'm, sorry, I missed that I'm, sorry, so it depends upon devotees that'd be a decision. If you can see they'll do gives a but you only deal. If you will not take between two month to month unfolding days two months in else heats up on there okay.

Okay, I'm sorry on the so.

Yes, my resolves all.

Yeah.

With respect to the P. Rx one zero so will it be manufactured so early in its rare or are you planning dramatic departure of the drug at an alternate inside.

So the drug substance is the current to manufacture in Israel and the final product activities being manufactured outside the fees right. If the we'd be any decision to aid the side, we will update of course it president these are the situation.

Okay understood.

So how do you see the planning to handle marker boxes on reimbursement and what kind of experience does your partner how in this area in the context of orphan drugs within the U.S. Margaret.

So generally the extensively beating their busy disease business globally.

He is based in both stone that both couple of process already and they have teams on the ground.

Okay. Both in the U.S. any in Europe, I think the vast majority of the themes.

Hey, probably all of them Oh, we sat extensive experience in Drake Brickell. The road disease menu of then come from specific rather these companies X genzyme and others. So in this respect I believe that they will do a very good job and so what city, we if we come they hate to fight.

Let me say so they have probably thousands of years of experience combining both continents already.

And there they'll actually strengthen the opposite ends of the.

You know hopefully approval and launch and next year.

Great <unk> quoted 19 had any impact on analyzed snow.

Brazil.

So what did we quantified.

So its president I want to be careful its presence.

Thanks for the first off we don't see any influence and I hope this will continue into the second half of it twentytwenty and so currently not.

Okay, Great and one final question are you, making any progress on identifying potential licensees bar Opie Rx ones, They don't Fracs and the Rx boardwalk at all on that in my recent developments all these from.

So we all walking on the potential collaborations if once that we'd be something three bolt of course, we live in both the Golden.

Okay. That's it from me thank you for watch.

Thank you.

Thank you know once again, ladies and gentlemen kick you a question at this time. Please press star one on your telephone keypad.

Our next question comes from the line of Silicon Gardiner with Jefferies. Please proceed with your question.

Hi, there I'm just two questions for me, possibly too early to say, but I was just wondering I'm like to have a NSPI Advisory committee meeting its possible that routine.

The regulatory submission and then my second question was just I get a manufacturing I think you know he is the product cart you'd be made up let's see that's already being inspected. So do you think that the FDA review will require not the inspection facility or how do you get the FDA my handle that bank.

<unk>.

So I was told me the second question, because I didn't know I apologize, but they do not understand the first along the line was not a clear with regard to the first question our side was.

All these doesn't inspected in July 2019 successfully with no 43.

This thing we already saw another really inspection if a we'd happen again I don't know if you do they.

Hey, Colby 19 needs, we have been but clearly we already there was no issues that but if you don't mind to repeat deal. So your first question.

Yeah. It was just what the hook I'd be an advisory Committee meeting its Paul says that the <unk>.

I mean do you know the being able to submit then they will follow the regular procedure. So we're supposed to get the PDUFA date, and then to review cycle and as part of it the probably I'm I don't know what we had been due to the koby 19, but we expect a.

You know inspection by the F.D.A.M. there was a view on that.

That's.

Clearly a discussion.

Okay. Thank you.

Thank you.

Thank you and the final reminder, ladies and gentlemen, if he would like to ask a question at this time. Please press star one on your telephone keypad. Please hold while we pull for any additional questions.

Thank you we've received a question from a line of lots are called <unk>, a private investor. Please proceed with your question.

Oh, the them wanting gentlemen, congratulations on your progress.

Oh, I have a portable questions or how many warrants have been exercise.

Since a financing.

Yeah.

I'll I'll take a a the question the worst than not exercisable there are blocked for six months I. According to the deal. So none of them were exercised at this point.

Okay. Thank you.

Oh are you aware of the.

Company called Kentucky Bioprocessing.

That works with the tobacco protein and what they're doing with that product line.

I'm not aware room.

Probably my team is aware of this is all speaking.

Right.

Okay.

What is the plant protein a behind the lump so product.

They laser product these carrots and the Uh huh.

The rest are always be way too we jumped the buses.

Okay, when well, one though to be a given a marketing name.

And who do that.

This is a good question. So it's a it's up to p. as it would be so I could do they can sotheby's else about these kids he's a decision and I hope so.

It's something that they propose namely least listening to the FDIC I believe and then they get approval.

I see okay.

Oh, Thank you very much.

Congratulations on the progress.

Thank you Sir.

[noise]. Thank you. It appears we have no additional questions at this time, so I'd like to pass the floor back over to management for any additional closing comments.

[noise] so thank you.

Oh, thank everybody for the time and a game.

I wish all across a good Henderson to continue we see.

Improvement in Maine, Protonix. So thank you very much.

Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation and you may disconnect your lines at this time.