Paion AG

Paion AG

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Q4 FY2019 · Earnings Call TranscriptMarch 26, 2020

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Operator

Good afternoon, ladies and gentlemen and welcome to the Paion AG conference call hosted by Dr. Jim Phillips and Abdelghani Omari.

For the duration of the call, you will be on listen-only. However, at the end of the call, you will have the opportunity to ask questions.

[Operator Instructions]. I am now handing you over to Ralf Penner to begin today's conference.

Please go ahead.

Ralf Penner

Thank you very much for your kind introduction. Ladies and gentlemen, I hope everybody is well and thank you very much for joining us for Paion's earnings call on the financial results of 2019.

My name is Ralf Penner. I am Paion's Vice President, Investor Relations and I will be moderating today's call.

I am joined by Jim Phillips, Paion's CEO, as well as Abdelghani Omari, our Chief Financial Officer. Within the next half hour, we are going to highlight some of the 2019 achievements, give details on the financial results, highlight the most important events and provide a pipeline and strategy update and financial outlook.

After this initial presentation, we will be happy to take your questions. I would like to point out that the slides for the presentation can be accessed by webcast in parallel to this conference call.

The webcast details has been posted on our website and were also given in today's press release. If you have not already opened the webcast link, you may want to do so now.

This conference call is being recorded and the replay will be available later today and will be posted on our website. Before we get started, I would like to remind that today's call may include forward-looking statements and that actual results may vary from Paion's current anticipations.

I would also like to refer to the disclaimer included in the presentation slides. After these initial remarks, I believe that we should now start right on with the presentation.

Jim, please go ahead.

Jim Phillips

Good afternoon or good morning, if you are outside of Europe, to everyone. My name is Jim Phillips and I joined Paion in October as the new Chief Executive Officer with a view really to put into place a strategy to grow revenue, become a revenue based business and commercialize remimazolam through our partners and in certain territories potentially on our own.

We will take you though the corporate update and then the financials and come back to kind of some of our thoughts and plans for the next year. Next slide please.

So just to remind you, we are an emerging specialty pharmaceutical company and our focus is anesthesia, our first core product and critical care. So these are products used around the operating theatre and intensive care settings.

Remimazolam is our lead candidate. It has its first approval post the end of last year in Japan and further marketing authorizations are underway across the world.

We have commercial partners already in the U.S., China, South Korea, across Asia, Canada, Russia and the old Commonwealth of Independent States, also across Turkey, Middle East, North Africa, Japan. So pretty much across Europe and South America and Australia, the world's commercialization process is covered through our partners.

Most importantly, I think given the Coronavirus situation and the impact on capital market, our current cash at the end of last year was €18.8 million. That was more than it was at the end of 2018 and we are looking at the year in which we have access to a lot of cash, as you will see, in terms of projected revenues, the European Investment Bank loan facility and our current cash, which means that we have no immediate needs to look to the market and the capital markets to raise money.

So we all very well capitalized and we have access to the cash that we need for three years or even more if we need to. Supervisory Board, no changes there in the last month.

This Board has been in place for some years. Markus Leyck Dieken was our most recent joiner.

And it's a Supervisory Board that fulfills all of its obligations with due process. Okay.

Next slide please. So our strategy is becoming very clear now, I hope.

We are bringing remimazolam as a product to market over the next two years with the first launch we anticipate in Japan in the coming months, then the U.S. and then other markets.

So over the next two years, there will be multiple launches of the products. What we also want to do is, build our own commercial capability in certain geographies.

We are still working on which of those geographies we are going to take up on our own to build that focus in anesthesia and critical care. But launching one product on its own and building sales forces around that is not necessarily the most cost-effective way to sell a product.

So we are also looking at opportunities to bring in other complementary medications to enable us to leverage our sales force and to grow revenue faster. And the ultimate output of that is that we plan to become a profitable business, certainly within the next five years, maybe quite a bit sooner than that and also become a leader in our field with fast revenue growth.

Next slide please, Ralf. Management board, we are will here on this call.

So myself and then my background for those who don't know, originally a physician. I took an MBA in London many years ago.

And I hold another non-executive position outside of Paion in Finland with a publicly listed company there called Herantis Pharma. Abdel, who is on the call, has been our CFO for a number of years now.

Six years, in fact and as you know, done a very good job in steering the company's expenditure over that time. And Jürgen, who is also in on the call and may answer some of the questions at the end depending on what they are, has been our Chief Development Officer for the last three years, but has also been working with the company for longer than that.

So that's our Management Board for you. Next slide please.

In terms of the listing, we have clearly been affected by the current market situation which is essentially Coronavirus derived stock market fold. If you look at our comparisons, we are very much not adversely affected any more than the rest of the market and particular the biotech and specialty pharmaceuticals market.

Market cap today, actually looking just before the call, we were more like €117 million €118 million. And so I think my message to investors and analysts is that we think we are very undervalued, particularly in the current market, but also with the cash resources and the access to cash that we have, we have no need to expand our facilities and to go to the market for cash in the coming years.

So here we have a company that is doing well, has enough cash to take it forward through its commercialization process without an immediate need to come to the market in these difficult times. Okay.

Next slide. So to remind everyone, remimazolam is indicated for potentially three different uses.

The first on the slide is for general anesthesia. The second is for procedural sedation, so things like colonoscopies and endoscopies in patients.

And the third, which is earlier stage for us, is intensive care use for sedation which you might think is possibly what's needed today in the current environment with so many people needing respirators. But of course, this is not an approved indication for us anywhere in the world yet.

But it certainly demonstrates the need for good new anesthetics in the future. Thank you.

Next slide. So what do we see about remimazolam drug compared with things that are on the market today?

So propofol and midazolam are the two compounds that are used in most instances. And propofol has some negatives.

It basically can cause cardiovascular and respiratory depression. There is no way to reverse it.

And there is some pain on injection. And with midazolam, the variability around the sedation that causes can be a big problem.

There is also risk of re-sedation and it has a relatively slow onset of action. So when you look at remimazolam, the things we see as our benefit, so there we have a rapid onset and offset, very predictable recovery time.

There should be less need for supervision after procedures. We see lower potential safety issues.

We have also a very simple to use reversal agent. So if you need to bring somebody out of sedation or after anesthesia, it's relatively easy to do.

And then during procedures, again, the supervision levels can be less. So therefore, remimazolam represents an opportunity to basically be able to substitute both of these other drugs in a way that brings benefits to the market.

Next slide please. Okay.

So next one. So in terms of what we just described, of course, safety is a really important thing in anesthetics and particularly amongst anesthetics, as you will see in the next couple of slides.

The avoidance of cardiovascular effect is something that we are looking at remimazolam as potentially helping doctors in treating their patients by, when they are under anesthetic, reducing the instance of hypotension and improving their hemodynamic stability, which can be very helpful in the morbidity post-operatively or post-procedural. There is also quite a lot of evidence from our Phase 3 study in the U.S.

that predictability of overall procedure time and the improved patient throughput by time-saving brings efficiency to healthcare provider. And then across patient experience in cost savings, we see the ability for hospitals or clinics to treat more patients because of the on/off effects that's faster, the reduction in resources required and that patients are back to normal faster.

So therefore, it's easier and you get patients through and out of the clinics faster. Okay.

Next slide please. So just to remind again of the compound itself.

So it's intravenously given benzodiazepine-based sedative and anesthetic. The intellectual property, the patents run through between 2031 and 2033.

We are still working on trying to expand the patent portfolio at the present. In terms of safety, there is more than 2,500 patients and volunteers being treated to-date.

So there is an extensive safety database now. And the indications are well underway now.

So general anesthesia is approved in Japan. Procedural sedation, we are looking to, we hope to get the FDA approval in the next four months.

And we have the potential to take this product though intensive care unit sedation too. But we have not yet started that work.

So there is a large market for these indications and we are looking to capitalize on that market and the relative lack of innovation in that market the last 30 years. So what we have seen to-date, the solid efficacy and safety, there is rapid onset and offset of action, what seems to be an appropriate depth of sedation and a good hemodynamic response which may be a big advantage for us, particularly in general anesthesia.

Okay. Next slide please.

So in the U.S., which is obviously one of the largest market, there are more than 20 million procedures per annum in procedural sedation in the area that we are particularly looking at and that is a market that is really attractive, both in terms of what we can show for doctors and patients and in terms of the financial and revenue potential for the U.S. market.

Next slide please. So procedural trials were run in the U.S.

and you can really see here the dark blue on each of the graphs in each of the studies, essentially showing remimazolam having highest successes in procedures than either placebo, as you would expect or midazolam as comparator. So these studies are very important in that they show that across three different types of procedure and patient groups that remimazolam increases the output of the clinic in terms of their ability to complete procedures.

Next slide please. In terms of the colonoscopy study in the U.S., this really talks to the U.S.

market where you can see that two key premises in terms of time-saving in the clinic where remimazolam had a faster onset and a faster offset of action reducing the time of the whole procedure by around 22 minutes which, if you think, the average endoscopist or colonoscopist is doing roughly 10 a day, then they would, on the aspect of 22 minutes times 10 patients, you are looking at 220 minutes. So potentially three to four more patients being able to be served a day which is a big increase in efficiency for those units which are paid by procedure.

Okay. Next slide.

So the U.S. launch plan.

The FDA, as I think everyone is aware, extended the PDUFA date and this was extended to July. Basically what happened was there was some additional data which was asked for and submitted in January and February and the FDA, particularly in the current environment with this Coronavirus epidemic, are taking their time and need to take their time to review that thoroughly.

So we do not see any particular negative connotations from this extension and we are reasonably confident that we are looking at an approvable product over the next few months. No further clinical data has been requested and everything the FDA has requested has been supplied by us.

On the assumption that we get green lights before July or early July, then we would anticipate that our partner, Cosmo and their sublicense, Acacia Pharma, will be launching the product in the second half of the year. We are working closely with both of them as Acacia undertakes their own sales force sizing targeting.

Clearly, there are two core targets in the U.S., the gastro physicians, working mainly outside the hospital setting and the anesthesiologists who work in a combination in and outside. Next slide please.

So in Europe, we have also submitted our dossier for procedural sedation in November, post the approval of the pediatric plan that you have to have in Europe. And what we are looking at in Europe is potentially building up our own distribution structure in certain markets but we need to extend our portfolio.

So I am not really saying that we are going to launch remimazolam alone. We want to be able to launch other products alongside it so the sales force is effectively used.

We will also be considering and are looking at options for finding partners and outlicensing remimazolam as an alternative, which may be in certain territories and could be eventually, if we don't find out products, could be through a complete licensing out. So that's what is ongoing and of course we will keep the market updated as to how that develops.

Next slide please. There, general anesthesia, okay.

So again, GA, I think we talked to most of this slide but really one of the key things is that as many of the current population undergoing general anesthesia and surgery stay are elderly and there is increasing evidence that post-operative complications are related to intra-operative hypotension, so low blood pressure. It's a very strong predictor of myocardial necrosis and post-surgical mortality and acute kidney disease, myocardial injury and other cardiac complications are raised, where there it seemed to be intra-operative hypotension.

So that leads to a 30 day mortality rate but is seen to be higher. So therefore, we see that with remimazolam so far in the studies we have completed, there is a lower instance of hypotension compared to propofol and that could be a really significant advantage because that potentially could lead to less of these very serious long term and short term consequences of the operative procedure.

So there is an opportunity for us for remimazolam to be a really big improvement in the treatment of patients on the general anesthesia and impacting the patient care and their outcomes. Next slide please.

So just to build on that myocardial injury. So that's not quite the same as infarction but it's similar.

It's basically any event that can damage the heart muscle. It's often silent.

It's particularly around operative surgery. It's relatively common and it also can be very deadly.

So more than eight million people have silent myocardial injury worldwide. Most of them have no symptoms.

There is 4% mortality at 30 days and 8.5% of these have an MI and the cardiac arrest when they die. So it's an important part of thinking about patients holistically before they have surgery, during surgery and after surgery.

Next slide please. And this slide just points to a very important paper that was published last year about post-operative delirium and also one of the unexpected findings in this study was really that the mortality was lower in guided group and reduction of hypotension related myocardial injury was concluded to be something that would save many lives.

So there is an increasing body of evidence that hypotension has a very poor outcome predictor in anesthesia and therefore a product like remimazolam that may be less hypotension would be a significant improvement over existing products. Next slide please.

So we have a Phase 3 study going on in Europe for general anesthesia. This is now in second year.

It would be reaching its second anniversary in July. Multicenter, randomized, active-controlled study in around 500 patients.

Essentially Coronavirus had an effect on this study. So as of yesterday, we had 424 patients recruited to this study and essentially most sites because of the intensive care needs and the resources that are being diverted to Coronavirus has now stopped recruitment for the time being.

Next slide please. So our plan would be that as the pandemic cools off and hospitals and society returns to normal, we will talk to regulators and discuss about whether we should and whether we need to and when the hospitals have the capacity to recruit the rest of the study.

We are at a point where, subject to those discussions, we have the potential where we need to be able to continue the study or stop the study and still file with the current number of patients for the general anesthesia indication. So that will be the subject of discussions with the regulators over the coming months and as this Coronavirus pandemic plays itself out in the world.

Okay. Next slide please.

So this is just a summary of some of the data that supports our hypothesis that remimazolam maybe a safer product to use and regarding the hypotension and myocardial and consequences. So you can see remimazolam in blue and the comparator propofol in gray were both around hypotension.

The need for vasopressors which are drugs that increase your blood pressure, you see that remimazolam has a lower incidence of both hypotension, it's almost half that of propofol and certainly much reduced need for the drugs to put the blood pressure back on. So these are post hoc analysis.

But this work and our analysis of all the data in all our studies will continue. So we hope we will continue to see this improvement in patient's blood pressure during operative surgery and the beneficial consequences of that can be attributed to using remimazolam.

Next slide please. In terms of the European target population in anesthesia, this is restricted to high-risk patients.

So there are more than 70 million procedures on the general anesthesia and the high-risk patients are around 14 million of those patients. And it's that area around the general anesthetic population as opposed to all anesthesia that remimazolam will be focused on.

And the number of high-risk patients seems to be increasing as the population ages and people go into hospital for surgery with more co-morbidities alongside the thing that they are in for the surgery for. Next slide please.

Just a little review, again, of our commercial partners. So all of those blue areas in the world, apart from Europe, which currently is reserved for Paion to commercialize, are partners.

So you see the gaps are essentially South and Central America, Australasia, Southern part of the Indian subcontinent and Africa. We are working on Latin America, Central America, Australasia and those are our focuses in terms of potential new partnerships going forward.

Next slide please. So just to remind you, some of the core partners at the moment.

So Japan, we have Mundipharma K.K., where the product was approved in January. Currently there are discussions with the authorities over pricing and we would hope to see a launch there in the middle of the year, certainly in late Q2 to Q3 would be the timeframe and that's Coronavirus permitting.

At the moment, most pharmaceutical companies do not have sales reps out selling products for obvious reasons. So that would be a proviso around any launch over the next six months, which is somewhat dependent on the Coronavirus situation.

To the right, South Korea and Southeast Asia, Hana Pharm. So they have filed in South Korea for general anesthesia.

Hana Pharm also extended their license territory by adding Southeast Asia earlier this year. So it's a very positive development for us.

And they are looking for market approval in Korea in the second half of the year. In China, Yichang Humanwell have filed a marketing approval just well a year-and-a-half ago now and they are looking for an approval.

They hope to get in the middle of the year. So that would be potentially a second or third approval with the U.S.

coming soon as well. R-Pharm in Russia, Turkey and Middle East essentially are preparing for filing.

But really what happens there is that they are basing their filings on other approvals. So we are in a position where we are essentially waiting for the filings to take place.

Same in Canada where Pharmascience would use the U.S. dossier as the basis for filing for approval in Canada.

Next slide please. In terms of the milestones and revenues that are expected, I think that it's fair to say that this last year was a good year in terms of milestone based revenue at $7.5 million coming in from Cosmo and further $0.5 million from R-Pharm.

But we expect 2022 to do far better than that. We already have significant income this year from milestone payments.

There is a €15 million payment that would come from Cosmo on approval in the U.S. And essentially those payments are what are guiding our forecast for this year.

So there are plenty of royalty based payments and milestones due in 2020. And from 2021, we will be looking forward more to royalties rather than milestones so that revenue will become less lumpy, but we hope it will be fast growth and more predictable.

Next slide please. So now I am going to hand to Abdel.

He is going to through the financials.

Abdelghani Omari

Thank you Jim. Good afternoon everyone.

I will now guide you through the financial key figures for 2019 compared with the previous year and also give a financial outlook for this year. But first of all, I would like to summarize the two financing agreements that we signed in 2019.

In June 2019, we signed an agreement with the European Investment Bank for an unsecured loan of up to €20 million. The loan is available until June 2021 and can be drawn in three tranches.

For each of the transfer, specific conditions must be met. The first tranche of €5 million is available but we have not drawn it yet.

The second financing agreement is for the issue of unsecured convertible notes with a nominal amount of up to €15 million in up to three tranches. The issue price is 95% of the nominal amount.

And the first tranche of €5 million was issued in September 2019 and exclusion of preemptive rights. To-date, convertible notes with a nominal amount of €2.9 million have been converted into 1.4 million Paion shares in total.

The notes don't have a coupon and are due by the end of this year but we can extend the maturity by 12 or 24 months against a cash fee, if we decide to do so. Finally, we are not planning to issue additional tranches of convertible notes under this agreement.

Let me now move to the P&L. Next slide please.

Revenues amounted to €8 million, of which €7.5 million relate to the milestone payment from Cosmo for NDA filing in the U.S. and €0.5 million relate to the transfer of the Japanese filing dossier to R-Pharm.

Revenues of €2.8 million in 2018 were mainly realized in connection with the license agreement for Japan, South Korea and China. On the upper right-hand side, you can see that research and development expenses amounted to €13.1 million, which is an increase of €4.9 million compared to 2018.

The R&D expense is mainly related to the European Phase 3 study in general anesthesia and the validation of commercial scale production. The increase compared to the prior year mainly results from higher expenses for the ongoing Phase 3 study.

General, administrative and selling expenses amounted to €5 million and increased by €1.6 million compared to the previous year. This results from an increase of both general administrative as well as selling expenses.

General admin expenses increased by €0.4 million to €3.4 million, mainly in connection with the two financing agreements that I just outlined. And selling expenses increased by €1.2 million to €1.6 million.

This increase mainly results from pre-commercial activities and work related to the supply chain for remimazolam. In total, a net loss of €7 million was incurred compared to a net loss of €9.9 million in 2018.

Now let's move to the balance sheet and an overview of headcount on the next slide. Total assets increased by €0.6 million compared to end of 2018.

While the trade receivables are €1 million lower than end of 2018, cash and cash equivalents increased by €1.6 million compared to end of 2018. As you can see on the upper right-hand side, this increase stems especially from negative cash flows from operating activities of €2.8 million on the one hand and positive cash flows from financing activities of €4.4 million on the other hand.

Cash flows from financing activities mainly results from the net proceeds of the convertible notes that we issued in September 2019. As you can see on the lower left-hand side, equity decreased by €6.1 million to €14.7 million end of 2019.

This change mainly results from the net loss of year and the conversion of convertible note into equity. The equity ratio was 59% at the end of 2019.

The staff development is illustrated on the lower right-hand side. Compared to an average number of 39 employees in 2018, we had 44 employees on average in 2019.

At the end of 2019, we had 45 employees. Finally, I would like to give an outlook for 2020 on the next slide.

This year, our focus is on the completion of the ongoing Phase 3 in Europe, market approval process in the U.S. Europe and other regions, the build-up of supply chain and commercial manufacture of remimazolam as well as the market preparation and start of commercialization of remimazolam in different territories.

We expect revenues of approximately €20 million. They are up €15 million in connection with expected market approval in the U.S., further revenues related to the market approval in Japan, our license extension with Hana Pharm to include additional countries in Southeast Asia and potential market approval in further regions.

Royalties from commercialization of remimazolam in the U.S. and Japan are expected in a small amount of less than €1 million.

Given the ongoing development activities, including the European Phase 3 study and the start of the pediatric development, we expect R&D expenses to come in at a range of about €10 million to €12 million. SG&A expenses will increase to approximately €7 million to €9 million, mainly because of pre-commercial and supply chain activities for remimazolam.

Due to changed tax legislation in the U.K., calculation and capping rules for R&D tax credits have changed. Therefore and based on the expected revenues in 2020, we only expect tax income from U.K.

tax credit in the minor amount which is therefore not included in our forecast. In total, we expect the net result in the amount of approximately minus €1 million to approximately plus €3 million in 2020.

Regarding our liquidity, Jim has also pointed out, cash at hand plus the expected milestone and royalty payments secured cash bridge into the second half of 2021 based on current planning. And with this, I hand back to you, Jim.

Jim Phillips

Thank you. Next slide please, Ralf.

So in 2020, there is a lot of things that's going to happen for Paion which we see as positive things. So the completion of Phase 3 study, we still expect to complete this year, one way or the other.

Commercial launch in Japan is coming. And then the potential market approval in the U.S.

from the FDA. We are expecting further filings by licensees and further potential market approvals in China, Europe and South Korea towards the end of the year.

And then of course, the most important events, single event in the year would be post an approval in the U.S., the U.S. market launch through Acacia, the commercializing partner there.

So there is an awful lot of positive triggers and positive signals that we should be able to bring to your attention over the coming nine months and we see 2020 as a really important and pivotal full year for the company as we turn from being an R&D focused and spending company into a company that's got real revenue, royalty based streams of revenue and has the potential to launch itself through commercial infrastructure in Europe too. Next slide please.

So I think now we are going to move to the Q&A session. So I hand back to you Ralf or am I just holding here.

Ralf Penner

No. That's fine.

Thank you very much Jim and Abdel for the presentation. And now, as Jim suggested, I would like to as the moderator that to start the Q&A session.

Operator

[Operator Instructions]. The first question comes from the line of Simon Scholes, calling from First Berlin.

Please go ahead.

Simon Scholes

Yes. Good afternoon.

I have two questions. The first is whether there is any possibility at all that given the diverging of resources of the FDA to Coronavirus, there could be a further extension of the PDUFA date?

And the second one is, I was wondering if you could enlarge on your current thinking on remimazolam and the intensive care unit?

Jim Phillips

Okay. Thanks for the question.

Regarding the FDA and further extensions, I would hope not. We are in effect in the FDA's hand and I can understand and be very sympathetic to the refocusing of all their efforts towards approving Coronavirus tests and potentially vaccine trials, et cetera.

However the FDA has a divisional structure and our division, I would not think would be that affected because of the specialized nature of the way in which the FDA operates. I think it would be unlikely but I wouldn't count it out completely that there could be a further extension because of the Coronavirus situation.

It also, of course, depends on staff availability and staff who might themselves be affected by the shutdown, self isolation, et cetera. So I think the message is, we hope not but the uncertain world in which we live in at the moment means that there is a risk.

Simon Scholes

Okay. Thanks.

Jim Phillips

Second question around remimazolam and ICU. I think we are doing some work at the moment in the company and we are doing two things.

We are looking at the investment to bring remimazolam through to an approval in ICU, intensive care unit sedation and the potential returns from that investment. And the things that affect that potential, the investment is relatively fair but the returns are affected by pricing, uptake, potential uptake and the time of market exclusivity.

So we are still doing that work and we will be making a decision before the end of this year and informing the market accordingly as to whether we are going to proceed with the indication or not.

Simon Scholes

Okay. Thanks very much.

Operator

The next question comes from the line of Christian Ehmann, calling from FMR Research. Please go ahead.

Christian Ehmann

Hello. Thanks for taking my question.

I hope everyone is well. I will ask two questions, if I may.

So first, regarding the possible EU entry. Could you give us a little more estimate on the delay regarding the supply chain and the application in light of the current delay which was caused by the Coronavirus?

And second of all, can you give us a little more insight and the more details on plans regarding possible add-on products? You talked about this a lot already.

So are there any, can you give us more detailed explanations? Thanks.

Jim Phillips

Okay. I am going to answer the second one and then I will give you part of an answer to the first and maybe I will hand to Jürgen Beck just to cover the rest of the first question about the European Union GA study and the EMA situation.

Christian Ehmann

Thank you.

Jim Phillips

So in terms of add-on product. We are continuously screening the market.

We are not looking to bring in any old low value product. We are looking at higher value products which have high growth potential.

So these are few and far between and of course we will inform the market as soon as we have something that is becoming reasonably certain. But let's just say that it is a very path of my and the business development teams work currently.

In terms of your first question about the European study and EMA delay, I will hand it to Jürgen in a second. But just from my perspective, I think it is reasonable that if we get the procedural sedation indication approved in Europe at the end of this year, early next year that we will still be in a position to potentially file around the same time as we intended to for general anesthesia.

But let me hand to you, Jürgen. May be you want to pick up from that.

Jürgen Beck

Yes. Thank you Jim for giving me the opportunity to comment on that question.

Yes, in fact, at this point in time, with all the caveat which is necessary in the times of Corona, we believe that there will be no major delays because we think that we have built in enough room for maneuver to keep the timelines we have thought off before the Coronavirus spread out. Also as Jim as mentioned before, we might come to a conclusion with regulators that what we already have in the Phase 3 study might be sufficient.

Then there would be no foreseeable risk that we would not go in with GA as planned. However, it is very hard to make predictions, anticipation in these days.

So I want to ask you for your understanding that that is just the guess of the moment which might change if the Coronavirus crisis deepens and more restrictions are put in place and if, for example, also the healthcare authorities, EMA and the national authorities which work with EMA are hit by the disease itself and don't have their efficiency.

Christian Ehmann

Of course. It is so difficult times in these times to give accurate prediction.

Operator

[Operator Instructions]. The next question comes from the line of John Savin, calling from Edison.

Please go ahead.

John Savin

Hello. Thank you.

I just wondered if you could clarify how many sites you have on the GA trial? I can't seem to find that figure anywhere.

Jim Phillips

Jürgen, would you like to answer that?

Jürgen Beck

Yes. That were 21 before the Corona crisis.

Currently, we have 16 who have told us that they don't see some person in position to recruit anymore. So the overall number is 21.

John Savin

So it was 21. It's come down to 5?

Is that right?

Jürgen Beck

Yes. That is right, yes.

John Savin

Yes. Okay.

I have couple of follow ups. You are expecting now the CHMP to make a recommendation in 2021.

Is that right? Or would you expect a recommendation this year and a commission sign off in 2021?

Or are you not clear either way, if yet?

Jim Phillips

Jürgen, would you like to take that?

Jürgen Beck

Yes. What do you call a recommendation.

A recommendation with regards to what's going to happen with 2022, said Jim.

John Savin

A recommendation from the EMA that the commission should approve it and then the commission will issue a formal approval, is it, 67 days later?

Jürgen Beck

You are talking about the approval of general anesthesia?

John Savin

Yes. Or rather the PS, it seems to me, PS.

Jürgen Beck

Of PS, yes. We would expect that either in the late months of this year or very early in the first quarter next year.

John Savin

So it would be the CHMP opinion in that time period, okay. And how long do you think the GA abbreviated application will take with the EMA?

Jürgen Beck

Well, that is usually about six to nine months.

John Savin

Okay. That's great.

Thank you. Okay.

Thank you very much.

Operator

We have no further questions. So I will now hand you back to Ralf Penner.

Please go ahead.

Ralf Penner

Yes. Thank you very much everybody for asking your questions and for joining us for Paion's earnings call on the financial results of 2019.

I hope that we have been able to answer your questions. But of course, please feel free to give me a call afterwards.

If you would like to listen to this call again, please visit our website where the replay MP3 will be posted later today. For now, I say goodbye.

Thank you very much for your continued interest in Paion and most important, stay healthy. Thank you very much.

Operator

Thank you for joining today's call. You may now disconnect your lines.

Hosts, please stay connected.