Q4 2020 Protalix Biotherapeutics Inc Earnings Call
Okay.
Yes.
Good morning, ladies and gentlemen, and welcome to Proteolix Biotherapeutics fiscal year 'twenty 'twenty earnings Conference call. As a reminder, this conference call is being recorded I would now turn the conference over to our host Mr. David Holmes of lifestyle adviser Investor Relations you May begin your conference Sir. Please proceed.
Thank you operator.
Welcome to for college Biotherapeutics for fiscal year, 'twenty, one financial results and business update.
Conference call.
With me today are go on for Shaun.
Executive Officer for Telus and you all know the Chief Financial Officer.
Press release announcing our results for the update was issued this morning and is available now on the photonics website.
Bob if I 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 statements made factors that could cause.
Actual results to differ are described in the disclaimer.
Its filings with the U S Securities and Exchange Commission.
I will now turn the call over to Mr. Tomorrow for sure.
Sure.
Thank you David.
Welcome everyone to the companies year end of 2020 financial results.
During today's call I will review the progress of all key clinical programs and lay out the roadmap with our upcoming strategic milestones. Following my remarks, Paul Rubin, who will review our financial results.
And then open the line for questions.
Yeah.
For many challenges including of course, the unexpected global pumping.
However, we have achieved many significant accomplishments throughout all the states.
And we have continued that positive momentum.
And the first part of 2021 together with all development and commercialization pulp a POC, we submitted to the U S. F D. A BLA for per rigs one two for the treatment.
Patients with Fabry disease.
We look forward for the Fda's response.
We continue to be.
Oh, the clinical profile for PRA, its one or two we've released skewed that's off from the breach in the bright phase III study and we look forward to seeing interest from the button and studies during the second quarter of this year.
We further advanced our earlier stage pipeline of candidates for use for our per Se lakes are appropriate at the plant.
Satan based protein expression system and earlier this year, we strengthened our balance sheet for its public offering and through the stages of Sir shares under our ATM program overall I'm very proud of all employees and I'll extend my partners for their unwavering commitment to advance our mission to bring deferring.
Critics to the market.
Address unmet medical needs.
Please let me now provide some more details regarding the old P achievement in upcoming anticipated milestones.
Our lead pipeline candidate is pegged give me going to bode well for them.
Okay, Alex one or two which is a terrific growth.
On the bridge for the treatment for pretty busy for me the road genetic diseases with a cozy one early cold calling people and most experts agree the Dell mainly I'm, Doug most patients suffering from this disease.
The current therapeutic market for for brain disease competes consists mainly of enzyme replacement therapy.
And is forecasted to be around $1 9 billion target in 2021 and continued to grow with the cage or a per.
<unk> nine and a half questions.
As I mentioned earlier for the FDA accepted the BLA filing for PRA for no tool for the preclinical for grade disease and granted the BLA priority review the original Purdue per action day January 'twenty seven 'twenty 'twenty. One was subsequently adjusted EBITDA to April April 'twenty, seven 2021.
We in kids, we have remained in active dialogue with the FDA and as indicated in the PMA filing communication that led to a loss for the FDA does not plan to hold an advisory committee meeting to discuss the application.
If indeed, we receive an approval letter for colleagues and kidney ready for commercial launch of generics one O two.
Later this year we.
We continue to build low clinical profile for one or two as a result are released from our comprehensive phase III clinical program, which is composed of three studies the bridge the bright and the bottom studies last December we released final results for the 12 months brings afraid three open label single arm switch over trial.
Up to 22 for brief patients who were previously treated with a gotcha.
I'll start with Cologuard.
The data shows substantial improvement in renal function as measured by mean.
Annualized Egfr.
In both male and female patients who were switched from a galaxy Alpha Craig even goes on for us.
The final results from the breach draw and represent in greater detail in the annual World Symposium. This past February.
Last month, we announced positive top line results from the bright phase III 12 months open label switch over study designed to evaluate the safety efficacy and pharmacokinetics or per unit. Once he does all from two milligrams per kilogram administered every four weeks for the treatment of fabry disease and for brief patients.
He did with commercially available enzyme replacement therapies for at least three years and on a stable dose administered every two weeks.
Applying results, indicating two milligrams per kilogram per rigs one or two administered by intravenous infusion every four weeks was found to be well tolerated amongst treated patients and stable clinical presentation was maintained for adult <unk> patients. Following the 12 months' political period.
Presenting potential.
For an additional treatment regimens, one day is considerably more convenient for patients without compromising safety and efficacy.
The lead study in our Phase III program is abundance right, which is the 24 months try to evaluate the safety and if he could feel figure. Indeed go cheap that's all from one milligram per kilogram dose every two weeks in assessing its effect in fabry patients declining renal function versus the current used and then replacement therapy from Brazil.
Yeah.
We expect to receive income results.
From the drive in the next quarter.
Then serve as the basis for the European MAA filing.
Yes.
Try and resolves all pose it to you there is a potential for a commercial launch in Europe in the late 'twenty 'twenty two for the first half of 2023.
Turning to our early pipeline programs, we continue to what we saw from with U S. A to develop an enormous alcohol opioids, one thing which is produce viable for sonic system.
For the us.
Yeah.
In the treatment of any human respiratory disease or condition, including but not limited to so called doses put them on all the proposals and other related diseases via inhaled did equally well.
We recently announced an exclusive partnership with Cellcom would you say for a button with the hope would be candidates for these disease areas.
Hey, Bill easily.
We look forward to continuing to develop this partnership when we update you on our clinical plans.
Well for performing preclinical testing of peer range 115 hour plane sales express for Comping, a pegylated jewelry cars.
It chemically modified and volume under development for the potential treatment of refractory gout.
<unk> is the most common implement tori.
Yeah.
Yeah I'll try this in the United States affecting an estimated $9 2 million adults and estimated approximately two per cent of the golf population is supposed to have chronic refractory disease.
Do you recall, and then converts uric assets too and the nation, which is easily eliminated through you're right you're right. However, the root cause and then does not exist for the industry.
Yeah.
We use prosthetics for express and optimize recombinant jewelry cause enzyme under development for the <unk>.
Potential treatment of refractory gout, which we are designing to have an improved half life, reducing engineers, who can potentially longer term fix.
We have also began developing well developed peer rates 119 old plane sales Express Pegylated recombinant human DNA was one product candidate, which we are designing to have.
Hey, no elongated half life in the circulation.
For the potential treatment for net related.
Next for neutral from an extra cellular traps are weighted like structure released bio activated macrophage the truck and Keene, if a variety of microorganisms.
According to scientific literature animal studies have demonstrated the DNS one treatment reduces net okay.
Oh for the modified deem as one may potentially enable effective treatment of acute and chronic conditions where.
We are planning to commence phase one clinical trials of both Spirit's one day 15 PM breaks 119 throughout 2022.
Turning to our balance sheet, we ended the year with 38.5 years out of minions from cash cash it could be billions in short term bank deposits and we raised an additional approximately $40 million gross proceeds in a public equity offering in the first quarter of 2021.
We also raised $8 eight millions.
Through the sale of common stock under our ATM program during the first quarter of 2021, but yeah, we'll provide more commentary regarding our cash flow claims, but I would like to add that we feel confident about our balance sheet and I'll. Appreciate the support we've received from our existing and you added.
Institutional stockholders.
Before I turn it for young I, just wish to recognize what the challenging time this world for all of us.
And restate how proud I am.
For the team for their focus and commitment.
We did not allow this global pandemic to have a material adverse effect on our operations. We are looking for to an exciting year ahead of photonics and all of our.
Teammates and partners net.
Me, Tony Toyota for a review of her own credit options. Thank you.
Thank you Dror and thank everyone for joining today's call.
Yeah, Let me review, our full year 2020 financials for.
For the year ended December 31st 2020, we recorded revenues from selling goods of $16 2 million compared to revenues of $15 8 million for the same period of 2019.
Revenues from license and R&D services for the year ended.
<unk> 30 for 2020 or $46 7 million compared to $38 8 million for the year ended December 31st 2019.
Revenues from license agreements represent a revenue range, New York denied in conjunction with the <unk> agreement.
The increase is primarily due to the revenue recognized in connection with an updated cost estimation of the two completed phase III clinical trials per extra non too as Dror mentioned previously.
Cost of goods sold was $10 9 million for the years ended December 31st 2020 and 2019.
Research and development expenses net for the year ended December 31st 2020, with $38 2 million compared to $44 6 million for the year ended December 31st 2019.
The decrease is primarily due to the completion of two out of the three phase III clinical trials of pure external true and.
And reduced costs related to the phase three balance study as well as a decrease in costs related to manufacturing of our drug in development and some of them in fact for drug products and related costs have been recorded as inventory.
We expect research and development expenses to continue to be our primary.
Hence as we enter into a more advanced stage of preclinical and clinical trials for certain of our product candidates and for described previously.
Selling general and administrative expenses were $11 1 million for the year ended December 31st 2020, and increase versus $9 9 million for the year ended December 31st 2019. The injuries resulted primarily from an increase in share based compensation costs.
Financing that expenses were $9 2 million for the year ended December 31st 2020, compared to $7 6 million for the same periods in 2019 for.
Primarily related to the costs in connection with the senior secured notes.
As of December 31st 2020, our cash cash equivalents and short term bank deposits for approximately $38 5 million compared to approximately $18 million on December 31st two.
2019.
In March 2020, as you probably all remember, we completed $42 7 million private placement offering of common stock and warrants. This past February we raised an additional approximately $40 million in gross proceeds via an equity offering and raised an additional $8 8 million through our ATM during the first quarter for <unk>.
2021.
There are 58 million of convertible notes on our balance sheet that could potentially be redeemed. This November we believe that our current financial position provides us sufficient cash runway through the second quarter of 'twenty 'twenty two.
I will now turn the call back to usual.
Thanks for yield.
We believe we are well positioned for success and as we look ahead towards an anticipated commercial product launch with a so so financial base to support growth in the pipe and the pipeline of potential opportunities.
Look forward to updating you as the year progresses, and let's now please take all questions.
Thank you at this time, we will conduct a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he 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 just darkies once again Thats star one to ask a question at this time.
One moment, while we poll for our first question.
Our first question comes from Ron sounds your room with H C. Wainwright. Please proceed.
Hi, This is Bob Allen dialing in for Ron from Rajiv and thanks for taking my question, So I'd like to first.
What are your thoughts on Ela license sales performance in 2020, and what are your expectations for 2021.
We also would like to take it.
Sure.
So via sales that appears on our financials are mostly related to the Elisa and we talked about the $16 million in connection with their sales both to Pfizer and in Brazil.
We believe that they are 2021 is gonna be approximately in the same neighborhood.
Yeah, maybe a little bit or a little better a little stronger but day, yeah, given the pandemic in Brazil, we expect that day. The number is going to remain a quietly the same and the same for a pfizer.
Alright, great. So with respect to ones that are too I believe that beautiful day. It is approaching so what are your expectations on that and if the drug is approved by the FDA what elements could feature messaging to patients and physicians.
For us as far as we know if things are progressing as we.
<unk> updated our current per BOE per day. These April of 'twenty savings and hopefully.
Once we get approval.
We launched relaunched share shortly after.
I hope that they would be able to release in the next few weeks or few months.
Final results of the.
The bright study the one thing for weeks.
Clearly to publish the.
It comes from the interim analysis during Q2 over the balance study, which really hopefully supposedly we paved the way for submission for European Mi.
And the Union.
Adam.
Hi can you hear me.
Yes of course.
Right. Okay I thought the line went up a little bit on what can you comment on regarding the launch preparation activities for <unk> 102, and when can we learn more about the pricing information do you think there are X one day or two will be price premium well for farmers aren't.
But I used to just wait until we have approval and then we will discuss it with our partner and share with the market post approval.
I can assure you the preparations already.
Everything is set and we're ready to go.
Including the team the marketing sales medical et cetera and of course the.
Final product for the market.
Alright, one final from me can you comment on the market opportunity for moderate to severe pulmonary sarcoidosis.
So Wayne.
This is day one.
Very interesting indication.
And there is unmet need and you know, it's a not too many drugs.
Right no developed or approved for this specific indication. So if indeed things and we can go away and indeed this product will be further developed and its approval and we estimate that we estimate a big market.
Rich.
We will consists of many hundreds of millions of dollars book speak about.
You know years ahead, so it's difficult to two.
Two for coffee for Sweden Cross the billion downloads don't know right now.
That's it from me. Thanks, so much for your time.
Youre welcome.
Once again, ladies and gentlemen to ask a question. Please press star one on your telephone keypad. Our next question comes from John mentor Muslin with Zacks investments. Please proceed.
Hello, everyone and thanks for taking my question, let me start off with just a question on on the implications of the bright study.
Does that how might you go about modifying our talking for the F. D. A about modifying the label for for a different dosing periodicity for that is that something that you are planning or how how how should we think about that opportunity.
So the outcomes of the bright study.
Bright studies, most part of the B a day that was submitted.
So post approval and we really we plan to submit the clinical supplement.
Okay.
Very good and do you know what what might the timing be on that would it be in the next six months or so assuming a favorable april 27th outcome.
You know I go.
Want to commit I hope it will be on TD, you're in but I don't control the timetable weighted more so.
Okay.
I'm, assuming we'd be wiser range you know.
Both amounts owed to them for them to me.
Okay and for per ask 110, inhaled delivery seems like a very interesting approach and I'm wondering if there are other opportunities for inhaled delivery, perhaps nasal administration or something like that that that has some benefits for us for certain indications is that something that you might pursue.
At present, all inherited indications always for sarcoma coffee, Alex one thing I want to be very careful.
So you know this is the situation right now we are developing.
And a low gate then.
Vietnam is one.
For full mix related diseases as I mentioned.
But this is a different thing.
Different category, you probably may see.
Okay, Yeah, it seems like an interesting opportunity, but obviously, we're kind of in the early stages for that last.
Last question for me is on the on the F. D. A and I think you've made a mention of this just the U S. FDA inspections I've been trying to get a sense of how those have been going in and wondered if you had any anecdotal observations on the FTAA inspecting anywhere even in United States or just how that that is going along because I know that.
That's a that's a key issue for them.
For everyone pretty much yours, who's waiting on a per day per day.
So indeed, its a key I don't have it.
We're generally view on what's going on in the U S. A.
There's one thing we have officially updates moving to share with the market of course.
Okay. Thank you I appreciate it.
Youre welcome.
Once again, ladies and gentlemen to ask a question Thats star one on your telephone keypad.
There are no further questions in queue at this time I would like to turn the call back over to management for closing comments.
So between both speaking of just us to thank everybody for the time and participation participation in this call and I wish everybody right.
And you know to be healthy and safe.
Good luck, thank you very much.
Thank you ladies and gentlemen, this does conclude today's teleconference. You may disconnect. Your lines at this time and have a great day.