Q4 2019 Earnings Call
Monday
welcome to the conference center. The next available. Comfort specialist will be with you momentarily. Welcome to the vet center. The next available. Comfort specialist will be with you momentarily dead dead.
Welcome to the Vivid comfort center. The next available. Comfort specialist will be with you momentarily.
Home, welcome to the visor comfort center. The next available. Comfort specialist will be with you momentarily.
Harborcenter, can I have a first and last name, please?
Okay, and what company you calling from?
What company are you calling from?
Okay, and you're calling for protalix?
After the tone, please clearly State and spell your email address then press the pound key to continue.
Thank you.
Dead dead dead dead.
Birthday greetings and welcome to the port Alex biopharmaceuticals reports fourth-quarter and full-year 2019 financial and business results conference call at this time. All participants are in a listen-only mode a 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 page minder. This conference is being recorded. It is now my pleasure to introduce your host Monique investor relations at Life by advisors. Thank you. You may begin.
Thank you operator and welcome everyone. Thank you for joining us today for discussion of fourth-quarter and full-year 2019 Financial results leading the call today will be president and chief executive officer of Fort Alex. He will be joined by a l Ruben Chief Financial Officer of Portales before we begin I would like to remind them that very statements made during this call will include forward-looking statements for the purposes of the Safe Harbor Provisions under the private Securities litigation Reform Act of 1995. Board looking statements include those regarding the company's future plans prospects and strategy financial goals and guidance product attributes and pipeline drivers of growth expectations regarding reimbursement and other statements that are not historical facts.
Management's assumptions expectations and opinions reflected in these forward-looking statements are subject to risks and uncertainties that may cause the actual results and or performance tujhe materially from any future results performance or achievements discussed in or implied by such forward-looking statements and the company can give no Assurance. They will prove to be correct and will not provide any further guidance or updates on the company's performance during the quarter unless they do so in a public forum. Please refer to the company's March 12th, 2026 and the risk factors included in the company's filings with the SEC for discussion of important factors that may cause actual events or results to differ materially from those contained in our phone not looking statements prior to this call. The company issued a press release announcing its Financial results for the fourth quarter and full-year 2019 results a copy of the release of the sound on the phone number.
reservations page of the company
Website with that. I will now turn the call over to Georgia Vashawn president and CEO of her Palace. Thank you. So good morning. And thank you for joining us today to review the company's fourth-quarter in here and 2018 operations and recent highlights during this call. I will provide an update on a clinical and corporate progress and then I will check to see if Ruben to review the company's financials before opening the lines for questions. So 2019 has been a pivotal year for protalix as we successfully expanded on the company strong Foundation Grewal team and entered into a new phase of development as a world-class recombinant therapeutic company. We're excited to continue our forward momentum through 2026 commercialization of all for free program, and we believe protalix is positioned for both near and longer-term success. We are extremely enthusiastic about the lead program. Yep.
With three fully enrolled phase three clinical trials ongoing we believe we have a robust clinical program in the industry and for the month of February and very significantly we anticipate to find a beard a submission to the usfda for this coming quarter back further Mo we anticipate final results of our bridge and bright rise in the first and second half of 2020 respectively which will further support our portfolio and evidence around. Protalus is putting pressures and firing in all cylinders right now and the energy among the entire staff reached New Heights full mm.
2020 is shaping up to be a banner year for the company. We look forward to advancing or clinical pipeline explaining ourselves involved in Florida laser treatment for the disease in leveraging commercial opportunity to spend to expand our Global footprint in the treatment of fabry disease.
I would like to review some of our major accomplishment over the last year beginning, of course with this morning announced financing today's announcement of 46.43 point seven million dollars pipe from some of the leading investors in Israel that the US underlines prothotics commitments to bring an important commitment to the public page our ability to secure this transaction under some of the most challenging Market condition in over a decade is a strong indication for the Deep interest in our technology and platform and serves as validation that are years of work with the public Community remains significant continued importance to these patients. The additional Capital will help us to progress are multiple choice in clinical trials towards completion as well as to further develop our early-stage Pipeline and serves.
to further infos
Oh a strong Foundation as we look to another truly transformational a year for products as we announced earlier this quarter with our commercialization part of Jersey. We received an agreement letter s t a full initial periodic study plan for Paris one or two for the treatment of a disease which outlines and approached for. One or two to address the needs of patriotic for three patients Thursday. We plan to submit a beer day for parents one or two via the FDA accelerated approval pathway next month based Based on data from the completed phase 1/2 cup controls of. One or two and ongoing phase three Bridge clean contrived earlier this year. We announced positive 12 months entering in Tremont treatment. I'm in the bridge stuff this demonstrates an important Improvement for kidney in kidney function in patients will switch from regular into. Ronald to this data help to support expect wage.
Is a finding under a third approval we have completed enrollment in the balance study our head-to-head phase 3 tries of Felix one or two for the treatment for breast disease this evaluates the safety and I feel fear is one or two compared to fiber time on the renal function in fabrique patients today. It's more than sixty six patients are being treated in our extension studies after opting to continue treatment with our product three Rs. One or two. We have also completed enrollment in our face, very bright tried of. This is an open-label switch over study to assess Fabrications previously known as we either fiber has a more regular gun and preliminary data showed prs100 to administrate over every four weeks results continues active enzyme throughout the entire month. This could be a significant benefit to patients as in huge in every two weeks in the current standard in this current standard-of-care today substantial. Yep.
Patients that were rolling this study remain on the four weeks those incredible regiment and we are continue treatment under the four weeks building regiment in long-term extension study. Finally in 2018. We were able to grow a team in both significantly my own appointment to president and CEO and director of in May was followed by the appointment of mr. Rubin and Senior vice president of ho in July 2019 in shortly thereafter or both of the rectum unanimously elected their Brownfield as chairman of the board and only recently in December 2019 am edit. The accomplished pulled out and went Monica 2 outboard. I'm very proud of our entire team commitment to the potential of Protonix despite years of current wage replacement treatments There Is Still Remains an unmet medical need in the fabric patients who continue to show progression laws of kidney function and accelerated approval of PRX one or two dead.
Brings hope to these patients.
Tweaker and that is the goal. We all walked all day every day. I will now turn the code to a on to review the financials.
So thank you drawer. And the thank you everyone for joining today's call. I would like to begin a the financial update by congratulating the team on the completion of the recent filing is announcing our press release the this morning after successfully secured funding agreement to raise a 43.7 million through a pipe financed by a number of the household names leading Israel US based investors, including Sagat investment house more investment house Highbridge capital u vs. Conor Rosen Capital month in a row properties and and lodging among others a retiree capital and they get who you're lucky served as financial advisors on this page is actions.
This post is from the financing will be used to advance our clinical programs and the commercialization of Purex one or two for the treatment of disease as well as to further develop our early-stage 5 p.m. And for General Corporate purposes.
For Dodge say will issue in sales the purchase an aggregate of 17.6 unregistered shares of common stock at a price of 2.45 per share Thursday. We generate a gross profit equal to approximately 43.7 million in this private placement. Each share issues was accomplished with the warranty purchase one share of of a common stock or the one shares at the exercise price equal to 236. The final thing is further described in the form 8-k which was five earlier today a job in the Securities purchase agreement attached to the form 8-k before getting into the 2019 numbers also mentioned that they in December 2019. We announced that the photography sell the special meeting of stockholders to propose the following too critical Financial amendments, which stoeckel is ultimately approved.
Her socks, please won't for 10 and a reduction is told number of shares of the company's common stock that protects is authorized to issue from 350 million to 120 million shares. We think are stockholders for this important vote and for the continued support of protalix, despite the challenging times in the market for the year ending December thirty First Choice.
2019 Passat recorded revenue from selling a of goods of 15.9 million increase of 6.9 million or 77% compared to revenue of 9 million for the same. Back in 2018. The increase is primarily due to the highest sales of analyzer in Brazil as well as the increase in sales of drug substance to Pfizer R&D expenditures next. We're forty four point six million an increase of 11.3% or 34% compared to 33.3 million for the same period of 2018 the increase results primarily from an increase of 9.1 million of the clinical trial related costs as well as a decrease of 2.1 million in Grants received from the Israeli Innovation authorities.
Is she in?
This is one nine point nine million a decrease of a million or 9% compared to 10.9 million for the same. In 2018. The decrease result of primarily from costs related to the company's home exclusive license and supplies agreement that the company entered into in 2019 with a partner which were not incurred in 2019 net loss was 18.3 million or 1.23 dollars per share basic and diluted compared to a net loss of 26.5 million or 1.8 dollars per share name is for the same period in 2018 December 31st. The company has 17.8 million dollars in cash and cash equivalents.
I will now turn the call back to Georgia. Thanks the odd. So we continue to progress as a worldwide as a world-class company in 2018 was transformational from Puerto Rico and I have to take this moment and think the many for being patience and investigators and other states stakeholders in all three people. Trials around the world our tremendous and Thursday technical stuff for the for their dedication and efforts and I'll share holder for the patience and support thank you again with that. I will now turn the call back to the operator and we will open the call for questions from the audience.
Thank you. Ladies and gentlemen, we will now be conducting the question and answer session. If you would like to ask a question, please press star one on your telephone keypad. The confirmation total indicate that your line is in the question may you may press star to if you would like to remove your question from the Q4 participants using speaker equipment. It may be necessary to pick up your handset before pressing the star key our first question on the line of Ram selvaraju with HC Wainwright. Please proceed with your question. Hi, this is dialing in for you and thanks for taking my question. So I wanted to walk out of a little bit to get to know more about the TV experience is is he basing facing any business operation disruptions due to the fact I was in Italy.
So first, thank you for the question. I think I will take the opportunity in which everybody not only who is listening to us. But everyone, you know the best health possible of course and you know, both of those families, this is very important, you know, the coronavirus is is worldwide and there is a a pretty significant heat in Italy wage is is for Alex. We don't see any any risk because it's it is in Italy pro-choice manufacture the product prothotics runs the clinical trials. So actually I think many of the employees of crazy which of course exist and walking is a very reputable company in Italy. They I think many of them work from home. So there is no harm and ongoing discussions. So it's true that they are not coming to let's say to Tel Aviv to meet. Yep.
But we are conducting on a daily basis discussions, you know over.
Video conferences or Etc so we don't see any let's say effect on the ongoing wage DVDs of Protonix ahead of submissions or clinical trials moreover. We are looking of course to make sure and we have stocks, of course in the different sides globally, whether whether 3 clinical trials are on going to have enough material for the patience, of course to to make sure and we do anything with any effort, of course to make sure I continue as planned.
Okay, the moving on the FDA indicated to you that it will only accept the vla for review Once the bridge Topline data becomes available in mid 2028.
We expect to if I if I heard you when we expect to have the the outcomes or the top lines of the bridge twenty patients after 12 months by April of 2020, which is a month.
Okay, and to the potential launch of the United States, I'm curious. Like what is the strategy to take the market share from competitors such as Amazon and do you have any details on pricing?
So as you probably know the the sales and marketing, right? Obviously, they are a walking in the last couple of quarters to establish in already made the effort and investment, of course to establish a a sales and marketing platform on the ground balls in the US in in the you also both couple of artists in the rare disease area. I think it is, you know under their hands and if I don't want to discuss if I may say pricing because I don't have the the data right now off, you know, this is it in a nutshell. We believe that the outcomes of the bridge the bride the mechanism of action of such that if in fact we get the approval by the end of this year as planned and we get on the market next year. We will be able to start to take multi-charger, you know from birth.
Either newly diagnosed patients or from the current commercial products to tell you exactly how much market share in how exactly is going to be done and not right now. Thanks for the information if I'm missing but I can assure you that the team on the ground both in the in the U is experienced it comes from I you know, they let's say The Usual Suspects if I may say and many many hundreds of years of experience combined, of course in each of the continent to establish a very good sales and marketing team.
Understood what are the current expectations for LED light for revenue from Brazil?
Can you repeat the question? I don't I could not I don't hear you. What I'm sorry. What are the current expectations for LED lights of revenue from Brazil?
So, you know in 2018 reported nine point 1 million dollars of sales. We expect a growth of about 10 to 15% year-over-year for the next couple of years. I don't know what wage five years of calls. It would be I think less responsible to say this is by patients. We see as I mentioned I think in the previous calls. Hi alignment between the number of lies in the orders and the number of the patients. We already have something like something like around 25% of the treated patients in Brazil or treated good shape patients will we expect it to grow again about ten fifteen percent year-over-year in the next couple of years.
Understood it on the business development activities with respect to opr X10 X10.
It's present I don't have news on that. We are as I mentioned we have engaged and we actually finalizing the the project these days. We have engaged with the scientific advisory firm couple of months ago. They have reviewed the capabilities technology pipeline structure Etc. We are reviewing it with our management involved in order to if I may say read find the strategy or a way going forward for the next few years and we will come out to open it to the market soon about it as part of it will be of course. That's what we do with one of 110-106. So each of the molecules that we have in our pipeline.
Okay one final question. If I made the company made any progress in potentially monetizing the protein manufacturing technology platform.
We I mean all I can say that we are working on potential collaborations right now based on our platform this actually expressing protein. So plant cells
Okay. All right. That's it for me. Thank you so much for taking my question.
Always, thank you.
Thank you. Our next question comes from the line of Peter Wilfred with Jefferies. Please proceed with your question.
Hi, thanks for taking my questions. I've got three please and firstly just with regard to sorry to come back to this. But the Kobe situation. I appreciate it. Obviously your Manufacturing in Israelis cuz you'll be home to five days. But just from the point of view of the current trials. I guess it could you give us some sort of visibility in terms of the the patient follow-up cuz obviously all your patience are enrolled now, which is a good thing in a sense that you're not trying to get new patients. But equally I guess now therefore you've got all those patients in the study. It's important that you still able to follow those patients up and you don't have the flexibility at this point now back to change sites or reallocate clinicians. So only if you could give us something update as far as procedures, you've got in place or plans to be able to ensure follow-up can be completed so that the trials can be it can be completed successfully and secondly then just on the financials and obviously very good to be doing the capital raised and can you give us some sort of Outlook maybe for cash burn this year's
How are you to be set this source of the call or some sort of guide as to how we should be thinking about the the the Run rate of of Optics during the course of this year and then just finally then I would you tell it to the easy. Could you just outline?
For us when the first Milestone remind us rather when the first Milestone will come from t a c and what triggers that Milestone. Thank you.
So thank you. I will address the first one. The first question is started. We are working closely with a quiver which is actually our vendor to run the clinical trials in order to check to see that we prepare adequately of call to the extent possible to maintain the clinical trials and continued then it could be either by home visits. So supporting with the patience to to come to the hospital the ones in two weeks for the confusion. We hold all kinds of preparation discussions. We make sure that we have enough of course material either our drug or fabrazyme on site. So, you know, as far as we know as of today, it looks that things are going well. I assume this is if I may say a general point for all clinical trials are probably hundreds. If not thousands of clinical trials globally we do age.
Thank you. Find me the extreme measurements to to ensure to the best that we can that these clinical trial inclusive of the extensions will be continued as planned.
This is one. So I will I will take the the second question if you don't mind they are able answer you so maybe you'll take the salesman, of course, so computer for during the school with regards to the burn rate a uh, as in previous year when dissipate that at least the first half a unless something unexpected things happen. And in this crazy Market, you can never anticipate our project but they we will keep the 7 and 1/2 million net been raised for the first half of the Year. Obviously Thursday, we go deeper and deeper into the uh, trials and extensions since there are a fully funded by KIA see so are a net burn rate is going to suck so we should expect a decrease in the second half of this year with the final thing and the expected the cash flow projections We Believe
Leave that the secured financing will keep us in the for the next two years based on our internal a plans and budget.
But I would like to edit I think by securing this close to forty four million dollars with the case we have in hand as we reported back that I can I can foresee. Of course. We are we have enough cash or secured enough cash to continue in work if I may say I'm in peace if I may say until the at least the minimum without doing anything else the end and the the final results of the bottom starting which is actually faith is supposed to be by e q one I believe a 2022, you know, why assume that you do not expect me just to sit on my hands. So I hope there will be more to do. I hope we will be able to cut off in collaborate with a sales parties on our technology and do other things but this to be followed, of course.
So I just to be clear. I guess this is my third question be sufficient funds for two years, perhaps beautifully excludes a milestone from chiese, which I think we should get on Thursday evening. Happens around the end of this year or early next year.
Yeah, so with regards to your third question about the Milestones so the FDA approval Argosy triggers, the Milestone the interim analysis a month also triggers one. Obviously, we cannot disclose the other figures but as you rightfully so said a this is going to be a triggering event for a getting those Milestones from birth to Kia's.
Understood. Thank you.
Thank you. So just to emphasize maybe I did not understood fully or question even with just by the money that we have raised and we have in cash will see without these additional Milestone. Not that we are not expecting a don't get me wrong. Of course. We all secured until the end of our fabric program and I think it's achievement by its own.
Yeah. I just wanted to make sure that that was that was what you would yeah, the cash is sufficient beyond the first the first quarter 22 balance excluding any Milestones. So with the milestones and should extend that room way beyond that.
Yes, sir.
Any further questions, 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 concluding comments.
Okay. So again, thank you very much for everybody. And I wish everybody the best health and meeting you again next quarter.
Thank you. Ladies and gentlemen, this concludes today's teleconference again. We thank you for your participation. And you may disconnect your lines at this time.
Dead dead dead.