Q3 2020 Protalix Biotherapeutics Inc Earnings Call

Greetings and welcome to the protest bio Pharmaceuticals third quarter 2020 financial results and business update at this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone.

Keypad as a reminder, this conference is being recorded its now my pleasure to introduce your host Investor Relations truck put dollar. Thank you Chuck you may begin.

Thank you Paul well.

Welcome to the metallic side with the pure third quarter 2020 for next Roosevelt's and business update conference call.

With me today are George for Sean for tablets, President and CEO.

I all Rubin metallic CFO.

A press release announcing results and the updates was issued yesterday morning, EPS is now available for Calix website.

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

The earnings release and the 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 that could cause actual results to differ are described in disclaimer and then foretell filing with the U.S. Securities and Exchange Commission.

I will turn the call over to Mr. drew arbitrage sure.

Thank you John and welcome everyone to the company, so what people Twentytwenty financial results and business update.

Before we start I would like to thank everyone for making themselves available for today's call since we had.

The schedule due to some technical difficulties affecting their conference call provider hosting the call yesterday, So we apologize for the inconvenience and as always we appreciate your time and support for Fox.

During the school, we provide an overview of the progress if all clinical program.

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Following my remarks, our Chief Financial Officer told me. So Yeah, we'll do you review the company's financial results before we open the lines for questions.

So we have accomplished a lot over the last several months importantly, we have announced if you accepted the BLE filing the Rx one or two full fabry disease.

So.

A couple of the date of January 27, and 2021.

The last patient.

[noise] completed treatment you know he's three bites bright stuff and.

We expect to report topline data from this study.

So in the first quarter sales went to 21.

We do good though with all the development and commercialization path Nokia globally, where this launch.

Launched an expanded access program in the U.S. and we and this will help us to continue indeed.

Yeah, our clinical data sets.

Finally, we're regaining the New York stock Exchange compliant in early September and unknowns and entry into it said the median at the market equity offering program with Bank of America Securities.

Clearly it was a highly productive well three no commitment to advancing go fight like Hell.

Programs and achieving progress.

The treatment.

These are just that you could use all the subjects for <unk>.

Now let me review our recent highlights in more detail Oh lead piping accommodating the human guys, who does I'm, sorry, Oh, well be fine yeah makes one or two which you've been through appointed.

Titan candidate for the treatment of disease.

In may of Twentytwenty.

Does it go but were diseases. These old corporations that needed to be related to the U.S. If you do an accelerated approval.

In August of this year, we have been known to be yes. It accepted the beauty and granted they play only to review designation. The FDA also indicated the beauty filing communication in the beauty finding communication nature and it is not currently planning to hold an advisory committee meeting to discuss that.

Okay Yeah.

If they said that they do for action date of January 27 to 2021.

And if there is advice that this part of the the interview process. We have to inspect though is really manufacturing facility and the facility. So it's probably probably know ours in Europe, who perform the freedom finish courses again, you've got you've got off.

Due to the Cobi 19 pandemic related to.

Actually a troubled restrictions. The EBITDA is involved is it maybe it would be unable to pull them coupon talk the inspections, probably it could be lumpy, though two week together with kids eat all in active dialogue with them and have submitted the request.

Do they have to be April a type b meeting to see 'cause your machine on this issue.

Okay, Great brand.

Brand licensing inspections of these two manufacturing facilities. Both of these fronts, we don't disagree and if they're in response to these requests.

Last week on November 20 Twond.

You know bunch of 2023, we together with gives you announced completion of the treatment period, the streets read write stuff.

Expect to release topline results from the bright spot for the first quarter looks like it went to one.

Right that'd be the 12 month study open label suite over study designed to assess the safety and the secrecy and pharmacokinetics will be at least one or two to me you're going to exceed a grump administered by intravenous infusion every four weeks.

52 weeks in patients, which probably leads pre written previously treated.

With an enzyme replacement therapy, such as far as I'm already.

The bright studies, all the second phase three trial I.

Oh, P.L. <unk> infinitely patients.

In photos the breach twine supposed to give results since we have announced LDL in may one of this year.

We anticipate results from leased from an interim analyses fall mange thought BPL takes one or two phase three head to head clinical study called the bottom stuff.

In the first half was Twentytwenty one [noise].

[noise] I'm, so grateful for the collaboration between our teams all of the patients and clinicians away being dedicated to be developing for a woman in spite of the challenges of the call. Good night.

We were pleased to announce.

We received notification from the New York Stock Exchange American New York Stock Exchange in early September and that will probably 'cause regained compliance with the owner will be continued listing standards that falls in public paying the New York Stock Exchange American Company Guy One September cool, what Publix was removed from the list of the Noncompliant.

Sure Hey on the New York Stock Exchange American website.

No. The October will unlock some kids, we announced the launch of an expanded access program.

Yeah, <unk>, the United States Hope helix, one out to you Pete allows access to figure in the country, because I've talked to a broader group of physicians and patients beyond those you know phase three program.

This need these open to patients with clinically diagnosed each fabry disease, who you don't opinions about treating physicians, there's no comparable all subjects victory until a few treatment options. We currently available vehicles Philippine spoke about.

We have three full decoupling, you're only took one provide access.

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To this important therapy option for his many eligible patients as possible more details regarding each program can be viewed on the clinical trials of Gol website [noise].

Finally.

I would like to ensure that we continue to focus on all bought on street in coffee cost structure to ensure we have missed this necessary resources to Pittsburgh.

Full of potential commercial launch in early 20, Twond Twentytwenty, one and to move our other development program called in early October we aren't going to be.

At the market equity offering sales agreement with Bank of America Securities isn't agent disagreement neighbors I'll still say from time to time ups to aggregate to filter media U.S. dollars.

[laughter] diesel bunk of America in terms and conditions to closing in these sales agreement. These.

These financing arrangements provided the company with great to copy for raising flexibility as we execute our commercialization and development.

Before we turn the call over to one object on different options I would like once again to thank all employees for their professionalism collaborations and pilots in full during these challenging times so 2020.

Then he continues to impact our business isn't on lives and he's running globally and we know it is not easy to stay focused imports.

Continued continuing to operate very worried as a team and we are very much in college bold exciting period ahead of us.

With that I will now turn the call over to a young who an overview alternators yuppies.

Thank you George and thank you everyone again for joining today's call and despite being convenience Oh, the rescheduling Yeah, Let me review, our third quarter 2020 financials.

For the three months ended September Thirtyth 2020 recorded revenues from selling goods of 3.3 million compared to revenues of 5.1 for the same period of 2019.

Degrees resulted primarily from the timing difference in sales to be really 2020 compared to 2019 why in 2018. The shipments were scheduled for the third quarter. This year. They are scheduled for the fourth quarter and this is the timing difference, which was partially offset by an increase in sales to Pfizer.

Revenue from license and R&D services for the three months ended September Thirtyth 30, 2020 were 7.5 million compared to 9.1.

For the same period over 2019.

Revenue from license and R&D services are comprised primarily of revenues, we recognized in connection with our license and supply agreement with kids.

The decrease is primarily due to the completion of two out of the three phase three clinical trials as well as more cost related to the balance study, which need obviously to a lower revenue that we record based on U.S. GAAP.

Cost of goods sold for the three months ended September Thirtyth was 2.9 million compared to 3.2 for the same period in 2018.

The decrease is primarily due to a change in our cost structure is as well as lower royalties paid to the Israeli innovation authorities.

Research and development expenses for the three months ended September Thirtyth was 7.7 million compared to 10 million for the same period of 2019. The decrease similar to what I've described in the R&D and license revenues is due to the completion of two out of the three a phase three clinical trials. If your next one or two.

And reduce cost related to the balance study as well as a decrease in cost related to manufacturing of our drug development. If some of those that affect your drug product and related cost could be recorded as inventories.

Selling and general administrative expenses were 2.8 million for the few months ended September thirtyth compared to 2.6 for the same period in 2019.

Fashion that expenses were 1.9 for the three months ended September Thirtyth 2020, compared to 2 million for the same period in 2019.

At September Thirtyth, 2020, or cash cash equivalents and short term bank deposits were approximately 41.3 million compared to approximately 18 million.

At December 31st 2019.

I will now turn the call back to drawer.

Thank you read on sales.

So as you have heard waver very productive.

Twentytwenty. So far we are looking forward for another productive quarter looking.

Looking forward also another productive year in Twentytwenty, one clearly the mix to a clique, we'll do it at all.

We could go to cope with Polycom, well very much optimistic I had two follow.

Hey, potentially approve on an opening game.

The results of the different studies during Twentytwenty, one and they of course, improving whole pipeline and frankly, that's like the pipeline going forward based on our unique to cool.

Thank you very much and stay where it is.

Okay.

Thank you we 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 a.

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You May press Star 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 star keys, one moment, please while the whole for questions.

Thank you. Our first question comes from Rahm Selvaraju from H.C. Wainwright. Please proceed with your question.

Hi, This is bill Baldwin dialing in for Ron Silver Roger can you hear me okay.

Yes, we do.

Okay, great I'll feel pleasure.

So for us to start up.

Really how many you watch on the European patients diagnosed with Fabrizio says Oh doing 2019, and what percentage of these patients actually to the standard of care operators.

Well I think it's actually I believe the billion dollar question, how many patients they seemed a couple of calls with each of the continent.

Mhm, though many diagnose patients is where do you are you.

Fumed go about three to four.

Thousand patients in each of the components today.

And the reason.

No way.

Probably a bigger number.

Which almost on frequent as we speak.

Hey can you be ask again on your second question about existing therapies.

So what percentage of these patients are treated but fabrazyme.

Some of them I believe holds the majority of the market.

How about the same as it was worldwide. So I think they have like.

Close to 90% in the U.S. and the rest is got a whole you say well what medication equals there's another another enzyme replacement therapy by child care, that's because it's not gonna would use multiple give viewers. However, because it will actually well talk to us so that outside the U.S. from one of my main plug the two year old to use share.

No my boat, so declined 40% Beach and gone up what holds in Europe, something like 20%.

We will take them that we can seek them on Bailey coal sales are they still this year.

And so as you can understand troubles army the Golden Star They'll do find me daily people, both on new years and okay.

Okay, Great with respect your expanded access program in the United States for parents bonds in October.

How many patients are expected to be treated overall do you plan to use this data with your ongoing spaced pretty pretty a future marketing activities.

Oh they separate.

In the expanded access program.

He he like there's nothing about the part of the phase three.

It's actually.

If you can.

And then the opportunity for patients, while we don't tolerate to I'm not satisfied with the calling treatment treatments to move into all four though.

I attribute side of the phase three which are ongoing the buttons, which isn't going to burn study.

How many patients I don't know, we just started about a month ago I hope there will be as many as book. It's possible you know any number would be just misleading.

Mm.

And your fingers.

He will just last week, we dealt with it.

So.

And then moving on.

You mean PLX ones, though too is up so doing only 2021.

What factors could potentially drive democracy penetration during only a lot of factors might slow down the market penetration.

So I think a first getting approval on litigation, we suppose you'd expect it to be told publication.

JV eggs, we Fabrazyme, Oh, Oh, right drugs, and we really understand it you really should get the dramatic study who potentially to be beast product would be a pooky.

I mean, I think that the outcomes of our phase one to the breach study and hopefully positive outcomes will fall once in four weeks, we choose a decent alleging making clearly a significant improvement hope all the relevant patient he's a very nice between 12 hour launching in Q1 was 2021.

Hey, this is on the positive side I think a real supposed to.

Publish results opening Truman obviously football balance study, which means all the patients up to 12 month leases for the old peanuts only to even be told Mickey. This is clearly a very nice day.

Finally, the Queen fall launch of the U.S. and then we would proceed of course.

Submission into the European authorities and if we do not be positive. These would slow down there I assume once we know that they would not be a big win for the launch. However, if the product is in the outcome. So far from the phase one two degrees and you'd be through the specifics to talk to people being accumulated into tissues the outs.

I'm from the switch over from with regard to our drug.

Hopefully you good results.

And then your regimens launching four weeks should be a very good support these big Greenfield to go into these products.

Great and I'm glad you mentioned about really optimistic.

Yeah, Okay, Yeah I think.

Thank you.

Yeah, and the next one you mentioned about the pediatric population and I really want to talk radio talk show on on that so from a clinical standpoint.

The similarities and differences between I don't hobby precious and pediatric how many patients and I would just like to beginning clinical trials do you have a timeline in mind and do you plan to use the same endpoints.

For the pediatric study that there are you how does clinical trials.

So I don't have the unfold I don't have the political in front of my eyes, and I can I can look and get back to you with regard to the endpoint.

Okay.

As far as I understand troubles I'm easy pool for kids, a whole children its called it up to 18 years old.

Bob that gets you can see the other dogs.

Good evening.

And we are planning to launch this thing study in order to be able to expand the old Navy also too.

Children, who suffer from severe disease to enable them to potential new.

I tell my people in the markets.

Okay, I'm really important.

Oh, Yeah I feel this is important just to maybe due to explain there is another today. The rebel two approved medications you probably want these troubles unfold probably patients.

In one easy Galafold, which is we say shuttling technology and therefore, we treat stu.

A portion of the probably population.

30% genetic wise it would be a genetic feet and you you can also see from that from that market share. So having another enzyme hopefully any boardwalk after shall we go schools.

Yeah on the market.

Yeah, I think there's a new hope for these patients and their families any too bold and play boastful adoption also piece of course.

Okay.

Last one from me do you plan to incur additional collaborations.

Platform over the next six to 12 months.

I for some reason your voice became a low can you weeks can you pretty you reask.

Yeah deal right. So.

Additional details.

On your platform over the next six to 12 months.

We we show will walking on that if we read these costs.

With multiple parties.

He boasts a licensing oh, though these let's.

Let's say based on our platform and also licensing eating all kinds of technologies.

Well ideas that can be also implemented without technology. So I hope within the next six to 12 months, we really maybe a bit too.

A two at the date of calls and to strengthen the pipeline, which is very much important.

Okay, all right that's it from me thanks, so much.

Thank you.

As a reminder, if he would like to ask a question. Please press star one on your telephone keypad, a confirmation tone on the K. Your line and then the question queue. You May press star two feel we'd like to remove your question from the Q.

At this time there are no further questions I would like to turn the floor back over to management for any closing comments.

Well. This is all speaking and I wish everybody to two continuing to be weird and thank you for the time and then I encourage everybody who has any questions or willing to approach us directly via email or phone numbers that tetra and we'd be happy to answer and thank you very much again.

This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.

I have a great though.

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