Q1 2021 Protalix Biotherapeutics Inc Earnings Call
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And I'm wondering ladies and gentlemen, and welcome to the Photonics Bio Therapeutics first quarter of 2021 financial and business results Conference call.
As a reminder of this conference call is being recorded.
I will now turn the conference over to our host Mr. Chuck <unk> of lifestyle of advisors of Investor Relations.
You may now begin the presentation.
Thank you, Rob and welcome everyone to the hotel expiry is due to the buyer.
First quarter, 'twenty, 'twenty, one and financial results and business update conference call.
With me today and Mr. Dror, Bashan, President and CEO of <unk> and Mr. IOL Rubin Chief Financial Officer.
The press release announcing the results and the update was issued this morning and is now available on the <unk> website.
Please take a moment to read the disclaimer about the forward looking statements and the press release the <unk>.
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 cause actual results to differ are described in the disclaimer and the <unk> filings with the U S Securities and Exchange Commission I will now turn the call over to Mr drove the Sean sure.
Thank you Chuck and welcome everyone on to the company's first quarter of 2021 financial results and business update you on.
And the call today, and we review the progress of our key clinical programs and updates on the roadmap of our upcoming strategic milestones.
Following my remarks, our Chief Financial Officer, and we got Rubin will review the company's financial results before we open the lines for questions.
We were obviously disappointed with the recent receipt of the complete response letter from the FDA last month.
And you are encouraged that the FDA did not report any concerns relating to.
And the safety and the efficacy of be Alex one of them. We are working closely with the agency and the anticipated the required of the inspection and subsequent assessment with the.
The completed once the agency travel and restrictions are lifted and we'll provide more detailed comments on the Seattle and shortly.
We are continuing to advance on earlier stage pipeline. Additionally, we strengthened our balance sheet during the quarter, we the public offering generating $40 million and gross proceeds.
And feel confident about our ability to continue to fund our clinical programs.
And as we prepare for the potential commercial launch of <unk> one of them.
Now let me provide.
Provides more details of both low quarter in late April we and all of development and commercialization partner, the TSV seem to and from the U S. FDA.
The average one or two for the treatment for adult patients with fabry disease and the CRA. The FDA noted the requirement to inspect for colleagues manufacturing facility in Colombia.
In Israel.
And the due to travel and restrictions as a result of the COVID-19 pandemic. It was unable to conduct the inspection during the review of cycle.
The FDA explain that it will continue to monitor all of the public health situation as well as travel restrictions and execute and he's walking the SKU.
And that outstanding inspections.
So all of the third party feed and finished facility for P of Exxonmobil in Europe due to the COVID-19. The FDA review of drink holds under section seven full a full of the federal food drug and cosmetic Act in New York and pre.
Pre licensing and inspection the FDA stated.
And the team will communicate and your remaining issues related to the facility and in order to seek prompt resolution for any pending items.
Third party feed and finished facility received the FDA com and just few days ago and share them with US together. We are reviewing these comments closely and quality with quality and regulatory consulting.
The last significant point, well highlighted by FDA and the luxury the summer zone was recently converted to a full approval of this new development and we need to be addressed in the context of any potential resubmission seeking accelerated approval of your average level.
Once again, why do we all of disappointing tourists and the CRA and we intend to collaborate and agree with the AP with the if the.
And on resolving the issues these issues and moving forward on the next steps we are walking on the scheduling of type a and of the review meeting with the EBITDA, which we plan to request from the FDA by the end of July and should take place approximately 30 days of.
From our request.
Our objective for the meeting.
Better understand the issues raised and the CRA and work with the FDA of and the plan and resolve these issues. We are confident in the overall and clinical profile. We have assembled swallow the development program and we believe parents, one or two would bring important valued the different patients with unmet clinical needs and we intend to update you on new developments and so as soon as feasible.
During the quarter and we continue to build the clinical profile of the 414 P of Rx one of them too.
We released positive top line results from the Phase III Bright study, which was designed to evaluate the safety and efficacy and pharmacokinetics of free of Rx, one or two treatment two milligrams per kilogram heavily at four weeks and up to 30 patients with fabry disease previously treated with commercially available enzyme replacement therapy topline result.
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Of Parex, one O two administered by intravenous infusion every four weeks was found to be well tolerated among the.
Treated patients and stable clinical presentation was maintaining the adult atopic patients our results demonstrate the potential for a more convenient and therapy option for patients without compromising safety and efficacy.
We expect to receive full interim results from our phase III balance drawn and the coming weeks and goodbye.
And the strategy of the double blind head to head and 24 months trial evaluating the safety and because you'll figure and they go and see the alpha one milligram per kilogram dosed every two weeks of your fabry patients with declining renal function versus some of them and the interim results are anticipated to sell of us.
To serve as a basis for the European EMA filing together with additional dock on the various clinical trials.
Subject to the results of the.
Balance trial, we could potentially have the commercial launch in Europe in the first half 2020 three.
We announced in February and exclusive partnership with Cellcom and USA for the worldwide development and commercialization of all of you go on these alcohol opioids 110 for the use and the treatment of any human respiratory disease or condition, including but not limited to South Korea. Those these preliminary free bros. These and other related diseases.
Hey, the delivery turning to our balance sheet.
We ended the quarter with 70 points for millions of dollars in cash which includes the proceeds from the public offering before I'll come on top of your February and the yard will provide more details around both financially and the moment we.
I'm confident the ball of financial position and our ability to fund our development loans for the year.
Before we turn to you on I would like to recognize again.
What the challenging time has been for all of us and emphasize to our team how proud of the whole proud day and of their focus and readiness.
This has been challenging challenging week for us.
Our local employees and he's run and we wish for imminent the peace and stability for a while now turning to of young for review of all pointing on shops.
Yes. Please.
Thank you George and thank you everyone for joining our call today, let.
Let me and review, our first quarter, 2020 one financials.
For the quarter ended March 31, 2021, and we recorded revenue from selling the of goods of $4 5 million compared to revenue of $5 million for the same period of 2020.
Revenues from license and R&D services for the quarter ended March 31st two on the 'twenty, one was $6 8 million compared to $16 6 million for the quarter ended March 31st 2020.
Revenues from the license agreements represent of the revenues we recognized in conjunction with the clear the agreement. The decrease is primarily due to revenue is recognized in the first quarter of the 2020 and connection with and updated cost escalation as well as completion of two.
Out of the three phase three clinical trials of tier one or two.
Cost of goods sold was $4 8 million for the three months ended March 31st 2021, and increase of $1 4 million of 41% from cost of goods sold all of the three and $4 million for the same period.
Last year we.
Increase and cost of goods sold was primarily the result of higher manufacturing costs.
R&D expenses for the corner of ended March 31st 2021 was $7 1 million compared to $10 3 million for the three months ended March characterize 2020.
This was primarily due to the completion of the two out of the three phase two clinical trials and.
As well as reduced cost related to the balance study.
SG&A expenses were $3 1 million for the three months ended March the first one and 21 compared to the three to four.
For the same period last year.
Financial net expenses were one 8 million for the three months ended March the first 2021 compared to $3 million for the three months ended March 31st 2000, and twin the decrease was primarily due to a decrease in expense is related to the outstanding convertible notes equal to one point.
$3 million.
As of March 31st 2021, as Jordan mentioned, our cash cash equivalents and short term bank deposits of approximately $74 million.
During the first quarter of 2021, and you raised gross proceeds of equaled $8 million from the sale of common stock under our ATM program and gross proceeds of 42.
Public offering of our own stock.
Net loss for the three months ended March 31st 2021 was $5 5 million or <unk> 13.
Per share basic and diluted compared to the net gain of $1 7 million or 10 cents per share basic and diluted and diluted for the same period of 2020.
I'll now turn the call back to you.
Thank you Adrian.
And we look forward to working closely with the EBITDA on the first of all of the fill rates of one or two for a guidance property of patients to be able to bring this important drug to commercialization.
The bulk of the continued continuing to advance our earlier stage pipeline and continuing to build the company for the long term success. We look forward to other things you updating you as the year of Progressive and let's now take your questions. Please.
Thank you.
At this time of the conducting a question and answer session and.
I like to ask a question. Please press star one on your telephone keypad and of confirmation tone will indicate your line is and the question queue do.
You May press Star two of you would like to move your question from the queue for.
And for participants using speaker equipment and may be necessary to pick up your handset before pressing of the sarkies.
One moment. Please so we poll for questions.
Thank you.
First question is from the line of from <unk> with H C. Wainwright. Please proceed with your question.
Hi, This is the one on dialing in for Ron Paul Roger and Thanks for taking my question.
Just to clarify so if the FDA conducted the site inspection on time the Onyx.
There are two without the approved alright.
Yeah.
Yeah.
Yeah.
So.
The U S as we share the publicly.
We already included the.
Right.
The two facility because one of the drug substance and.
And the.
The other one of the freedom finish of loans and the filter of peak and these older of course.
And the fact of the trial was language for the approved and the U S. So all of these topics has to be discussed with FDA.
And we'd be raised.
And do you think the type a meeting as planned.
And will be.
And we.
It will take place of course, and the then when we get clarification and direction going forward.
Understood and so are you on that of any cases and they have D. S.
And section due to the inability to conduct sites of you on time.
Yes.
The proposal about the whole the if you'll try and inspection.
And maybe.
And maybe there is another and alternative like a record of the view inspection, but they're getting and we all know deciding for the every day weekend, we all actually.
And.
But we will raise all of these alternatives and again with the FDA and hopefully it will come to the agreed upon solution.
Okay. So you noted in your press release that you will not cause the FDA type of meeting sometime by the end of July and then.
Assuming class one of the Resubmission. So do you of any thoughts of when FDA will conduct a site and stretched on the north side of so that's the third party site.
Can you repeat the with the rest of the San Francisco and I'm sorry.
So assuming class one resubmission and when do you expect the FDA and debt.
The site inspection and Dr site as the last of the third party side.
We don't.
And I wish I knew we do not control of those schedules.
The what we meant that we have by the regulation. We have 90 days is thought of as I know to request the type.
I think my thinking on the day of request the EBITDA if agreed.
And in Turkey day, the take the type a meeting takes place.
And for the sake of all the discussion if indeed, the type a meeting with the.
Example, and will take place in July and.
And then it depends on the the discussion of the type of meeting following up and we'd be able to decide on our range pathway for resubmission.
And then when the FDA will conduct and inspection in our Israeli site and or in the French site and we wish it would it be sooner than later, but you know we don't have control of the painting.
On the third so switching gears, a little bit so far because on one of the recently converted on the full approval. So what impact would this have an extra 102 and the addition to the lane really of prop.
Yes.
Yeah.
So this is what we plan to discuss with the agency, we hope that it will not be.
Clearly there is the delay because we got the CRM.
And it's clear.
Following this is exactly what we'd be discussing the type a meeting in order to resubmit and as soon as possible.
Resubmission after receipt of our there is of six months of the view of process. The time towards submission depends on what we'd be.
Cost and decided and you saw these type of meetings.
Yes.
So one final question from me, how did cash they react to the CRM and what kind of impact with the FDA inspection side delay at.
The site inspection delay have on your commercialization activity.
So first of the.
And the kids is almost all of it clearly disappointed with the CRA and I would like to mention of the kids we are actually.
Trust very much and with the product and the potential of the Rx one or two to be a good alternative for the fabry patient community going forward both in the U S and the U S and we will closely ahead, though for the you know preparing the type of thing and.
On the EU submission, which is unchanged.
From a timetable of point of view.
Thanks, so much for the additional clarity.
Okay.
Youre welcome and thank.
Thank you.
As a reminder, you for star one to ask the question. Our next question comes from the line of Jon Vander Watson with Zacks investment Research. Please proceed with your questions.
Good afternoon jewelry all let.
Let me start off with another question on I guess the order of events.
And related to the type a meeting and the inspection or are those independent of each other or most of you hold the or is it your understanding that you must hold the type a meeting of prior to and inspection and taking place.
And you think they'll know they'll knock the dependent on the job here and the type a meeting regulatory wise has its own schedule and as I mentioned, though on the day that we received the CRA and I think I hope I'm not mistaken the us So 90 days the two.
The request it type of meeting and from the day of the request.
The day to hold of this meeting.
The.
And we would like to do at the.
Think sooner than later on but with the rights to be the one.
Once we are fully prepared.
And the inspection wise, both of the Israeli sites and the French site and.
And this is up to the FDA actually.
And this is part of the.
And if I missed the communication with them.
Okay, so that that's still being the size.
Yes, Sir it's not decided.
And then and then Oh.
The French facility I think you said that there were some issues to resolve and I guess I'm just trying to understand kind of the the bottleneck of order of events. It seems like the inspection is the kind of the main thing and then they just minor issues at the French facility is that is that your understanding at this point.
So we are not commenting on the specifics here and the day, we all call them the walking together with all of the quality on the board authority consults on them on the face forward and hope to resolve these issues with the SBA.
Okay.
And and I and again I know, it's early and you haven't had your type a meeting but is there any sense that some of the data from the bright balance of British studies might be used as part of the of ever Resubmission.
Resubmission to the F D a.
Okay.
The.
And as far as I know.
Let's put it this way the gas.
And and and portfolio sort of preparing the doctor right now and.
The the BLA that was submitted the year ago. It was based on the phase one two plus the safety data from the.
And from some of the other studies, but the smoke free coffee doctors from the other studies and I assume that we will not true.
Combined the properties.
Again, the kidney and cathartic so looking.
And very seriously and close knit together and.
And I'm thinking the if I may say the briefing book ahead of these type a meeting.
Okay, Alright, Thats all for me and thank you Dror.
Thank you.
Yeah.
And.
Thank you.
Our next question is from the John Hudson and the private Investor. Please proceed with your question.
Hello and.
My question is do you anticipate any delays.
With the F D a relative to the Palestinian attacks on Israel.
And I don't think so that's sort of I do not.
Unfortunately, the pensions the here of security concerns about the hope it will be the.
And I can't say it will be sold soon but it will be cut them down and soon and.
On the life, we'd be back to normal normally if I may say it doesn't know what the normal.
As usual.
And I certainly hope so you know.
Yes, yes.
This is the true I mean, it's nothing state and nothing's changed and always kind of go free it's very unfortunate of what's going on right now very unfortunate.
And steel and we hope for the.
You know quite of the times very very soon and then you know.
Things are back to normal fundraising.
Yeah.
Thank you.
And there's really though like I don't know 10 of 65, a day from kind of the two New York or vice versa zone.
This is not the issue.
Yes.
Yeah.
Okay.
Thank you.
Thank you.
There are no additional questions at this time I'll hand, the flow right to measure for further remarks.
Okay.
So first thank you and I.
I wish to thank everybody for the time and we will keep updating you and once we would have the right of on top of of course, and I wish everybody a and b.
Very nice weekend, and I hope for a quite old days and Israel very soon thank you very much.
Thank you and this will conclude today's conference you may disconnect. Your lines at this time of thank you for your participation.