Hansa Biopharma AB (publ) (OTC:HNSBF) This autumn 2021 Earnings Convention Name February 3, 2022 8:00 AM ET

Firm Members

Søren Tulstrup – President & CEO

Donato Spota – CFO

Klaus Sindahl – IR

Convention Name Members

Christopher Uhde – SEB

Adam Karlsson – ABG Sundal Collier

Johan Unnerus – Redeye

Zoe Karamanoli – RBC Capital Markets

Dominic Rose – Intron Well being

Douglas Tsao – H.C. Wainwright

Operator

Hell, everybody, and welcome to the Hansa Biopharma year-end report for January by way of December 2021. For the primary a part of this name, all members can be in listen-only mode, and afterwards there can be a question-and-answer session. Right now, I am happy to current CEO, Søren Tulstrup. Audio system, please start.

Søren Tulstrup

Thanks, operator. Good afternoon, good morning, and welcome to the Hansa Biopharma convention name reporting the year-end outcomes for 2021. I am Søren Tulstrup, CEO of Hansa Biopharma. With me right now, I’ve our CFO, Donato Spota, in addition to our Head of Investor Relations, Klaus Sindahl. Right now, we’ll evaluation the general progress and highlights of our enterprise in the newest quarter, and supply a preview of our near-term milestones. Our presentation ought to take roughly 20 minutes, and after that, we’ll take your questions.

Now, please flip to Slide 2. Please permit me to attract your consideration to the truth that I will be making forward-looking statements throughout this presentation, and you must due to this fact apply applicable warning.

On the operational aspect, we have seen stable execution in increasing our market entry and geographical footprint in Europe. Pricing and reimbursement have been secured in 4 nations now, together with Sweden and the Netherlands, as on a person hospital foundation in Finland and Greece. Market entry procedures are at the moment ongoing in 14 nations following the submission in January this 12 months of an HTA file in Spain. By this, we now have now accomplished submission of HTA dossiers in every of the 5 largest markets in Europe. This can be a nice achievement by our market entry staff, establishing an vital basis for Hansa’s business rollout of Idefirix, and serving to to carry hope to the 1000’s of Extremely Sensitized Sufferers throughout the continent who’re at the moment ready for a appropriate kidney transplant.

Trying past the early launch nations, I used to be additionally happy that we might announce a multi-regional commercialization partnership in December of final 12 months with Medison Pharma, for Idefirix, in central and Japanese Europe and Israel. Medison is a extremely acknowledged world pharma firm targeted on offering entry to modern therapies in worldwide markets, and this business partnership represents the primary milestone for Hansa, as we proceed to broaden entry to IDEFIRIX past core markets. Within the US, we introduced that the primary sufferers in our pivotal ConfIdeS Trial in kidney transplantation, had been enrolled on the Columbia College Medical Heart in New York. The ConfIdeS research is evaluating imlifidase as a possible desensitization remedy to allow kidney transplants in extremely sensitized sufferers ready for a deceased donor kidney by way of the US kidney allocation system. We anticipate to enroll sufferers at 12 to fifteen main transplant facilities throughout the US, with the intention of finishing enrollment by the tip of this 12 months. The US trial will generate each vital knowledge and beneficial expertise at these key facilities.

In gene remedy, we’re happy to announce an settlement with AskBio, a subsidiary of Bayer, to judge the feasibility of imlifidase as pre-treatment forward of gene remedy in Pompe illness in sufferers with too excessive titers of neutralizing antibodies towards the AAV that’s used. This new collaboration with AskBio marks one other vital step within the implementation of our partnership technique within the gene remedy area, the place neutralizing antibodies towards the adeno-associated virus generally used as a vector in gene therapies, characterize a significant problem and the place we see vital potential for our antibody treating enzyme expertise to assist overcome this barrier.

Turning now to our ongoing Part 2 applications for GBS and AMR, as of February 2, we now have enrolled 23 out of a goal of 30 sufferers within the AMR research, whereas 15 out of a goal of 30 sufferers have been enrolled within the GBS research. In anti GBM, also referred to as Goodpasture illness, we not too long ago introduced plans to provoke a Part 3 research of imlifidase, following a profitable pre-IND assembly with the US FDA. The pivotal Part 3 medical research is anticipated to enroll roughly 50 sufferers throughout the US and Europe, with the primary affected person anticipated to be enrolled in 2022. As a part of Hansa Biopharma’s platform technique and our efforts to broaden the applying of imlifidase as potential remedy to alter the course of IgG mediated in neurological ailments, we are literally exploring new indications with a excessive unmet want. One such indication into account is allogeneic hematopoietic stem cell transplantation, also referred to as bone marrow transplantation. Desensitization remedy of sufferers with excessive ranges of donor-specific antibodies previous to allogeneic stem cell transplantation, is a problem. And at the moment, there aren’t any accredited medication for managing these sufferers. We imagine that imlifidase could have the potential to remodel the usual of care in these sufferers, by enabling clinicians to inactivate preexisting donor-specific antibodies previous to transplantation, thus enabling a profitable transplantation. We’ll get again to those thrilling alternatives later within the presentation.

Now, please flip to Slide 4. As I mentioned upfront, Hansa Biopharma’s business launch actions are progressing as deliberate. Our objective is to have a optimistic impression on sufferers as we work carefully with the transplant group to reshape the world of desensitization and combine Idefirix into medical follow as a brand new normal of care. Idefirix is the primary and solely accredited drug to allow kidney transplants in extremely sensitized sufferers in EU, who’re incompatible with a deceased donor, and the long-term market uptake of this modern product, is clearly depending on profitable early experiences in key early adopter clinics. As we mentioned on the third quarter name final 12 months, we measure our launch progress utilizing a set of key commercialization metrics, which straight impression future adoption and gross sales of Idefirix as a brand new transformative remedy. One such metric is our means to safe pricing and reimbursement on the proper value and on label, which clearly can be of key significance for the rollout of and uptake of Idefirix available in the market.

As indicated earlier, we on monitor to safe entry and funding market by market in Europe, with reimbursement now secured in Sweden and the Netherlands, in addition to on a person hospital foundation in Finland and Greece. Moreover, we now have ongoing market entry procedures in 14 nations. In the course of the fourth quarter, particularly, we initiated processes in France, Belgium, and Greece. Furthermore, a well being expertise evaluation file for Spain was submitted final month, which completes HTA filings in every of the 5 largest markets in Europe. On the medical aspect, we proceed to work with a lot of precedence facilities to make sure and optimize their medical readiness, as a lot of incompatible sufferers are being recognized and prioritized for kidney transplantations within the coming months. To this point, 10 clinics are thought-about clinically able to tackle extremely sensitized sufferers for incompatible kidney transplant, and we proceed to work carefully with extra facilities throughout Europe on their preparedness by way of coaching, to enroll engagement, protocol drafting, and logistics. In relation to the notice and curiosity metrics, we see intensive engagement with greater than 30 specialists committing to operationalizing HLA incompatible kidney transplants for a few of their extremely sensitized sufferers.

As highlighted at our final convention name, one of many key outcomes from the European Society for Organ Transplantation Congress in Milan final summer season, was the formation of a brand new workstream with main transplantation KOLs to arrange medical pointers for incompatible kidney transplant sufferers. This new ESOT workstream is anticipated to be a key driver for harmonization of approaches throughout Europe to transplanting extremely sensitized sufferers, and making certain optimistic outcomes for sufferers in transplant applications. As doubtlessly a transformative modern new drug, Idefirix remains to be thought-about experimental by many within the area, and the ESOT pointers additionally serve to obviously articulate the necessity to transplant these sufferers, who at the moment sometimes wait longer for a transplant, or most often by no means obtain one. The primary part of the ESOT pointers is geared toward offering an proof evaluation of the literature, with clearly articulated suggestions and statements of the problems for incompatible kidney transplant sufferers. The second part will concentrate on the use and affected person outcomes because the expertise with imlifidase grows throughout the transplant group.

Now, please flip to Slide 5. As highlighted at first of the decision, we not too long ago introduced a brand new multi-regional commercialization partnership in kidney transplantation with Medison Pharma, masking Israel and main nations within the central, Japanese European area, resembling Poland, Croatia, Hungary, and Slovenia. This is a crucial milestone for Hansa, because it helps increasing entry to Idefirix for extremely sensitized sufferers awaiting kidney transplants in markets past the early launch nations. The commercialization is predicated on the present conditional advertising and marketing authorization for Europe, and pending advertising and marketing authorization by Israel’s Ministry of Well being. An utility for advertising and marketing authorization for desensitization remedy in kidney transplant, was filed in Israel in June of final 12 months. If granted, Israel would be the first market outdoors of Europe the place Idefirix is commercialized. Hansa and Medison will collaborate on acquiring pricing and reimbursement in 5 nations which are scoped throughout the commercialization settlement.

Now, please flip to Slide 6. On January 3 this 12 months, we introduced a collaboration settlement with AskBio, a subsidiary of Bayer AG, and a totally built-in AAV gene remedy firm devoted to creating medicines that enhance the standard of life for sufferers with genetic ailments. The collaboration will consider the potential use of imlifidase as a pre-treatment previous to the administration of AskBio’s gene remedy in Pompe illness in a preclinical and medical feasibility program for sufferers with pre-existing neutralizing antibodies to adeno-associated virus. Underneath the phrases of the settlement, Hansa acquired a $5 million US payment upon execution of the settlement, and AskBio has a proper of first negotiation for a full growth and commercialization settlement following analysis of the outcomes from an preliminary Part 1/2 research. This collaboration with AskBio, marks one other vital step to the implementation of Hansa’s partnership technique within the gene remedy area the place neutralizing antibodies towards AAV vectors utilized in a broad vary of investigational gene therapies, stay a significant problem.

Please flip to Slide 7. A part of Hansa Biopharma’s platform technique consists of broadening the applying of imlifidase as a possible remedy to alter the course of IgG mediated in neurological ailments and circumstances. Towards that finish, the corporate is exploring new indications with a excessive unmet want. As famous earlier, one of many indications Hansa is at the moment exploring, is allogeneic hematopoietic stem cell transplantation, also referred to as bone marrow transplantation. These stem cell transplantations are sometimes acutely wanted in a variety of most cancers sufferers, with little or no time to search out an adequately matched donor. If we have a look at hematopoietic stem cell transplantation, we are able to distinguish between autologous and allogeneic transplantation. Autologous transplantations clearly do not characterize points as bone marrow cells are transplanted from the affected person’s personal physique to interchange the deceased bone marrow. In allogeneic stem cell transplantation, nonetheless, the scenario might be totally different. In lots of instances, haploidentical donors are sometimes obtainable to sufferers sourcing by way of mother and father, kids, or siblings, during which case the general transplant consequence is usually good.

Nevertheless, the presence of donor-specific antibodies or DSAs, can have a damaging impression on transplant consequence and the prevalence of DSAs in allogeneic hematopoietic unfold stem cell transplantation, is often between 10% and 21%. Specifically, the presence of those antibodies can lead to main graft failure, and can be linked to a considerably worse survival consequence for the affected person. There are at the moment no accredited medication to handle the sufferers with excessive ranges of DSAs, and present desensitization strategies are thought-about insufficient, thus stopping sufferers from having a doubtlessly lifesaving process. We imagine imlifidase could have the potential to remodel the usual of care by enabling clinicians join with DSAs previous to transplantation. And we’ve due to this fact determined that it is a precedence indication for Hansa to additional discover.

Please begin to Slide 8. Turning now to our two ongoing medical applications in antibody mediated rejection, AMR, and Guillian-Barré syndrome, GBS. In AMR Part 2 program, 23 out of a goal of 30 sufferers have now been enrolled, and we’re on monitor to finish enrollment within the first half of 2022, as beforehand guided. We additionally anticipate to announce a primary knowledge readout from the AMR Part 2 research within the second half of this 12 months, as beforehand guided. Within the GBS Part 2 program, we now have now enrolled 15 sufferers out of a goal of 30 sufferers. On this trial, we nonetheless have the impression of the persistent COVID-19 pandemic and the current emergence of the Omicron variants, resulting in an escalation in variety of infections and introduction of recent quarantine guidelines, have affected the supply of workers throughout a lot of our trial facilities. Moreover, the pandemic has led to a scarcity of IVIg, affecting the enrollment charge in this system at a subset of collaborating hospitals.

To be able to assist mitigate these hurdles and enhance the enrollment charge, Hansa has not too long ago simplified the research protocol, and we’re additionally actively supporting the hiring of extra workers at sure clinics, in addition to including two websites for the recruitment of sufferers within the UK and the Netherlands. Given the issue of predicting the near-term impression of each the Omicron surge and the results of the not too long ago applied remedial motion to extend enrollment charge, we’ll revisit our steerage for completion of enrollment in reference to the publication of our Q1 report in April.

In anti-GBM illness, also referred to as Goodpasture illness, we not too long ago introduced plans to provoke a pivotal Part 3 research for imlifidase, following a profitable pre-IND assembly with the US FDA. The deliberate research is anticipated to enroll 50 sufferers throughout roughly 25 facilities within the US and Europe, with the primary sufferers anticipated to be enrolled this 12 months. In kidney transplantation, we now have now enrolled the primary sufferers in our pivotal US trial, generally known as the ConfIdeS as trial. The primary two sufferers had been not too long ago enrolled on the Columbia College Medical Heart in New York, and we at the moment have 5 facilities open for recruitment. The ConfIdeS research is evaluating imlifidase as a possible desensitization remedy to allow kidney transplants to extremely sensitized sufferers ready for a deceased donor kidney by way of the US kidney allocation system. The US trial will goal 64 extremely sensitized sufferers with a CPRA rating of 99.9% and above, representing the group of sufferers with the best normal medical want. We anticipate to enroll sufferers at 12 to fifteen main transplantation facilities throughout the US, and intention to finish enrollment by the tip of this 12 months. This randomized management trial will generate each beneficial knowledge and vital expertise at a number of the key transplant facilities within the US. As beforehand communicated, we anticipate to finish enrollment within the ConfIdeS research within the second half of 2022, with a 12 months follow-up on EGFF accomplished by second half of 2023. Outcomes from the trial are anticipated to help a BLA and the accelerated approval pathway within the first half of 2024.

Now, please flip to Slide 9, and a abstract evaluation of our pipeline. As depicted on this slide, because of the continued progress over the previous few years, we now have developed a broad medical pipeline in each transplantation and autoimmune ailments. As well as, we now have thrilling preclinical tasks ongoing in most cancers and anti-drug antibodies, in addition to within the very promising area of gene remedy, the place, as mentioned, we now have two ongoing collaborations with Sarepta Therapeutics and AskBio. The intention in each collaborations is to evaluate imlifidase as a pre-treatment forward of gene remedy, with Sarepta investigating this method in Duchenne girdle muscular dystrophy. And within the case of the AskBio collaboration, it focuses on Pompe illness. The preclinical growth with Sarepta is progressing based on plan, whereas this system with AskBio has simply commenced. Upon profitable completion of those preclinical applications, we anticipate imlifidase to maneuver into medical trials. Past the gene remedy area, Hansa has additionally engaged in preclinical collaboration with Argenx, which is shifting ahead based on plan. The main focus of this collaboration is to evaluate the potential advantages of mixing imlifidase with efgartigimod, Argenx’s FcRn inhibitor.

With this overview, I now of hand over the decision to Donato, who will take us by way of a high-level evaluation of the 2021 financials. please.

Donato Spota

Thanks, Søren. Please flip to Slide 10. As Søren outlined, we achieved stable execution all through 2021 on our key priorities, together with assembly vital R&D, business, and organizational targets for the 12 months. Income for the complete 12 months of 2021 grew to 34 million krona, together with 15 million krona in product gross sales, whereas the remaining 19 million primarily stemmed from income recognition from the upfront cost the corporate acquired beneath the Sarepta settlement.

Please flip to Slide 11. We proceed to spend money on the Idefirix launch and our pipeline in accordance with our strategic operational and monetary plans. For the complete 12 months of 2021, SG&A bills amounted to 328 million krona, in comparison with 203 million krona for 2020. The rise in bills is in keeping with our targets to develop Hansa as a totally built-in business stage biopharma companies firm, and as such, displays our increasing business footprint and elevated actions, together with investments within the territories, advertising and marketing, market entry, and provide chain actions associated to the launch of Idefirix. Our investments in R&D amounted to 231 million Swedish krona for the complete 12 months 2021, which was roughly on par with our R&D bills for 2020. Investing in R&D and our pipeline actions throughout all of our 4 strategic pillars, stays a key precedence for Hansa, because it helps the long-term worth creation for the shareholders of the corporate. The web loss for the complete 12 months of 2021 was 548 million krona, in comparison with 423 million krona for 2020. The rise was primarily pushed by ramp-up of our business actions.

Please flip to Slide 12. Cashflow from working actions amounted to minus 481 million krona for 2021, which compares to minus 290 million krona for 2020. The rise in comparison with 2020 is pushed by our development on the business entrance, and the non-recurring 10 million US Sarepta upfront cost acquired in July of 2020. As of December thirty first, 2021, Hansa’s money place, together with short-term investments, amounted to $889 million Swedish krona, equivalent to roughly $95 million US. With our present money place and projected burn charge, we anticipate Hansa to be financed into 2023 as beforehand guided. I’ll now hand again to Søren to present the ultimate remarks.

Søren Tulstrup

Thanks, Donato. Please flip to Slide 13. Hansa Biopharma’s transformation into a totally built-in business stage biopharmaceutical firm, turned a actuality in 2021, and we proceed to exhibit stable progress in executing on our company technique, together with making vital headway in our efforts to construct an advance pipeline of beneficial drug candidates for uncommon immunologic ailments. Trying on the milestones forward, we anticipate to finish the enrollment in our Part 2 program AMR within the first half of this 12 months, with the primary knowledge readout within the second half of the 12 months, as beforehand guided. This steerage assumes no additional escalation of the COVID-19 pandemic. As regards to our GBS program, as we mentioned, it’s too early for us to judge the impression of current measures taken to extend the enrollment charge, in addition to the near-term impression of the current surge in Omicron infections throughout Europe. So, we’ll revisit our steerage for completion of enrollment after we announce our Q1 ends in April.

In anti-GBM, we anticipate to start a brand new Part 3 research, with the primary affected person enrolled in 2022. So far as NiceR is anxious, our next-generation enzyme program for repeat dosing eventualities, we anticipate IND-enabling tox research to be accomplished in 2022. Upon profitable completion of those research, we anticipate to advance the NiceR program into medical research. In our US ConfIdeS trial in kidney transplant, we not too long ago enrolled the primary sufferers, and anticipate to finish enrollment by the tip of this 12 months, topic to any potential impression by the COVID-19 pandemic. We look ahead to holding you up to date on our progress in advancing our mission to carry lifesaving and life-altering therapies to sufferers with critical, uncommon ailments, whereas producing long-term worth for our shareholders and society at massive.

Please flip to Slide 14. With this, we’re now able to take your questions. So, I hand over to you, operator. Please start.

Query-and-Reply Session

Operator

Thanks. [Operator Instructions] Our first query comes from Christopher Uhde with SEB. Please go forward.

Christopher Uhde

Hello there and thanks for taking my questions there, targeted on the medical program. So, I suppose my first query is, are you able to simply element the protocol change for addressing COVID that you simply talked about? After which, are you able to additionally inform us a bit of bit concerning the design of the anti-GBM trial? When do you anticipate to determine on a medical – sure, the precise medical technique for the (LOSTP) is my third query. Thanks.

Søren Tulstrup

Sure. So, first, so far as the element protocol adjustments, I do not assume that is the time to undergo the precise particulars. It is typically round some logistics round what must be performed particularly across the consumption of a affected person, one thing round weekdays. And so, our staff has been working with the clinics to make it possible for the very best circumstances are there for the clinics to truly settle for these sufferers. The principle problem actually is, as you may think about, the truth that they’re brief on workers, the truth that initially we had most of our facilities in only one nation, that was France, closely impacted by measures taken, quarantine workers, et cetera. And we have additionally seen, as I outlined, points round provide of IVIg. So, we’re doing what we are able to to make it possible for the very best circumstances are in place for the facilities to simply accept sufferers. And as I additionally detailed, we now have expanded a lot of facilities and likewise expanded the geographical footprint. So, we’ll get again to the place we stand and after we anticipate this research to be absolutely enrolled. It is simply not possible at this cut-off date, however actually, we hope this may occur in close to time period with the measures that we have taken.

On the second query was the precise design of the anti-GMB. So, we now have aligned with the FDA on the design of the research. We’re additionally, after all, consulting with EMA. We would like this to be a world trial, and the general scope we have mentioned can be 50 sufferers. We anticipate roughly 25 facilities. This can be a managed trial, and it is not one that will result in conditional approval however doubtlessly could be pivoting right into a full approval. The second query was particularly round hematopoietic stem cell transplantation. This can be a area that we, as I indicated, assume may be very fascinating.

Clearly in our dialogues with key opinion leaders, after which additionally the regulatory authorities, particularly primarily the US FDA, we do see a transparent unmet want in these instances. Initially, we need to concentrate on the malignant most cancers sorts, the place there’s, after all, a really critical scenario. This can be a pretty uncommon type of scenario to happen, however clearly, for those who have a look at the broader area, stem cell transplantation has actually seen vital progress and donor-specific antibodies do current an issue throughout a lot of totally different ailments. So, we’re excited by the chance, and we’re persevering with our dialogue with the FDA and regulatory authorities and specialists. it is too early for us to present a suggestion round, or steerage round after we would provoke a trial, however actually, we’re wanting into getting ready the protocol and getting the mandatory approvals and we’ll replace you as quickly as we are able to.

Christopher Uhde

Okay. Thanks very a lot.

Operator

Our subsequent query comes from Adam Karlsson with ABG. Please go forward.

Adam Karlsson

Hello. Thanks for taking my questions. First one on form of expectations for 2022, because it pertains to gross sales and variety of handled sufferers. you have apparent not supplied any exact steerage within the report. I used to be questioning whether or not you could possibly give any form of indication on both of those parameters gross sales or variety of handled sufferers. I think about – I imply, given the coordinate launcher you are pursuing, presumably you will have a reasonably good concept the place you may find yourself. Or if not, what are the elements, I suppose, past timing of reimbursing choices that might form of materially sway gross sales in 2022?

Søren Tulstrup

Sure. So, thanks for the query. we have mentioned this up to now additionally. Proper now, it will not be useful for us to attempt to present steerage round gross sales and sufferers. That is actually the early days of launching this transformative remedy. There’s a whole lot of shifting elements. And so, what we’re targeted on is basically seeing whether or not we have to hold or whether or not we see progress based on the important thing commercialization metrics that I mentioned earlier. Particularly, getting reimbursement on the proper value and on-label, seeing clinics getting clinically able to deal with these sufferers, having native protocols in place, having workers that has been skilled, et cetera. We’re clearly publication of pointers and so forth. And as I mentioned, we anticipate the ESOT pointers to be printed very quickly, which can be fairly useful wanting on the broader European area. We’re additionally curiosity and consciousness and help from key opinion leaders, et cetera, measuring that clearly. And we see very good progress. So, I have been concerned in fairly a lot of launches of transformative new therapies, and I am very inspired by what I’ve seen thus far. We’re primarily checking all these containers, and naturally, as quickly as we now have much less volatility and extra predictability, we’ll begin offering steerage, however at this cut-off date, it is simply too early.

Adam Karlsson

Acquired you. Thanks. And I suppose on that time of form of early key commercialization metrics, are you able to give any form of commentary on the expertise that early launch clinics have had thus far with imlifidase anecdotally then? And have any clinics began to deal with a couple of sufferers and second sufferers or so?

Søren Tulstrup

So, I can’t now and never throughout the coming calls, particularly. I imply, you may think about, a few of our only a few facilities and only a few sufferers, begin commenting on the result of what’s occurring in particular clinics and so forth. That can be fully inappropriate. What I can say is that clearly we now have excellent knowledge from our Part 2 trials, exhibiting 100% success charge in enabling transplantation, excellent graph survival outcomes. We comply with these sufferers for a few years. We’ve got good knowledge all the way in which now by way of 12 months three, 4, and into 12 months 5. And so, all of this and what we’re seeing available in the market right now, once more, as I mentioned, brings consolation to me that we’re on monitor, that it is a product that over time will hopefully allow a broader vary of sufferers to profit from lifesaving kidney transplant. And clearly, we’ll see knowledge be reported. I anticipate clinics to begin speaking about particular person affected person experiences in related scientific for a, et cetera. So that can come, but it surely’s simply not for me to touch upon every particular particular person experiences.

Adam Karlsson

Nice. Thanks. I am going to soar again into the queue.

Operator

Our subsequent comes from Johan Unnerus with Redeye. Please go forward.

Johan Unnerus

Thanks. Thanks for taking our questions right now. Just some complementary questions. What about funding for sufferers? Might you elaborate a bit extra particulars how that performs out? Presumably it’s essential forward of reimbursement and pointers.

Søren Tulstrup

Sure. So, funding for sufferers clearly occurs at a number of ranges, if you’ll. there is a nationwide degree. And in some instances, like in Sweden, it is a advice, after which it needs to be approached down by way of the areas, and the hospitals then should additionally negotiate getting a funds and so forth, so forth. In different nations just like the Netherlands, it is extra of a nationwide determination that’s robotically reimbursed and it is primarily applied. After which you will have – along with this, you will have particular conditions the place hospitals can apply for particular person sufferers to get particular person sufferers reimbursed and/or get the hospital reimbursed for bills related to treating particular person sufferers. That is what’s the case in Finland, as an example. In Greece, you even have at the moment permission for a lot of sufferers and funding in place for this. Along with these type of normal choices and particular person hospital-based choices, we’re additionally early entry applications in nations like France, the place there not too long ago have been adjustments making this a potential route for us. And we have a look at related forms of applications in different key nations in Europe. So, total, very proud of the progress. We hope to have choices from the German authorities and the UK sooner or later throughout the first half of this 12 months. As I mentioned, we now have ongoing processes in the entire high 5 nations in Europe. So, we’re on monitor and we see stable progress.

Johan Unnerus

There appears to be relatively pragmatic method, the totally different nations. And what – how usually are these opinions? Presumably, there can be a lot extra affected person suggestions from main middle publication, as you alluded to earlier within the name, and knowledge and through conferences, is one thing that might result in revisions within the agency forward of formal reimbursement?

Søren Tulstrup

So, once more, that is regular. I imply, you all the time have type of authorities knowledge as a product is being launched. What we now have gotten right here, I imply, you will have quite a lot of type of programs in particular person nations. In sure nations, you additionally negotiate volumes and all types of issues that may impression downstream uptake and so forth. However thus far, as I mentioned, we now have very stable help, and we now have optimistic conclusions. And importantly, we now have optimistic conclusions on the HTA dossiers that we now have submitted with the worth proposition, like in Sweden, the place it has been concluded that by the unbiased board reviewing the associated fee effectiveness, value profit of recent therapies, that imlifidase, on the value degree in Sweden, is just not solely value efficient, however it might even be a value saver for the system, relying on varied assumptions for dialysis prices and outcomes. And that’s truly one thing you see very hardly ever for these orphan docs. So, we’re very comfy with, once more, the worth proposition that we now have, and the response and the continued interactions with payers throughout Europe.

Johan Unnerus

Wonderful. And on a distinct, fully totally different manner, Israel is within the partnership with Medison. Is Israel first in queue?

Søren Tulstrup

If it is first in queue in what sense?

Johan Unnerus

Sure. I imply, this collaboration covers a number of nations, central, Japanese Europe, and Israel course. Which nation has spot on, most – has perceived longest on this? The place can we anticipate the gross sales actions or remedies and gene therapies mentioned? Is that Israel?

Søren Tulstrup

Inconceivable to foretell. In Israel, we now have this utility with the Israeli Ministry of Well being. And clearly, first we have to get native regulatory approval in Israel. Within the Japanese European nations, we’re leveraging the EU approval primarily. So, that is extra a query of getting pricing and reimbursement in place and so forth. So, it is two totally different as you already know. I can not predict particularly the place you will see uptake first. However that is vital. I imply, clearly this is only one settlement, proper? However for those who have a look at the broader geography of the group, there are lots of nations with vital alternatives, excessive volumes of kidney transplants, and clearly the identical points with sensitized sufferers. So, we do see this as a primary step in rolling out Idefirix to different key areas and nations. And we’re fairly inspired by the dialogues we’re having.

Johan Unnerus

Sure. And we are able to see that you simply broaden what might be known as the platform method in several collaborations. Are you able to say one thing concerning the prospects and pipeline, each concerning gene remedy and different business collaborations to seize different areas other than central Europe and Israel?

Søren Tulstrup

Properly, so two various things, proper? So, one, partnering effort is round making certain launch of Idefirix throughout the globe, primarily. So, that is one effort. And as I mentioned, we have taken a very good first step right here with the drugs settlement masking primarily Japanese European nations and Israel. Then clearly we additionally produce other forms of partnerships within the gene remedy area. We’ve introduced now two collaborative agreements with AskBio and Sarepta. And what we’re targeted on right here is basically producing knowledge with quite a lot of AAV vectors and in quite a lot of particular indications. Clearly, over time, we do see – it is our imaginative and prescient to see imlifidase and different enzymes getting used fairly broadly within the area. And our key prior is to make it possible for knowledge are generated now with, as I mentioned, number of vectors and gene therapies and in several indications.

And so, that is our key focus. We might even see extra exercise within the gene remedy area serving to furthering our agenda there. However proper now, we’re fairly proud of the setup we now have and the collaboration and the progress made. Clearly, within the autoimmune illness area, we now have an ongoing analysis collaboration with Argenx. That is additionally progressing very nicely. We’re wanting on the potential mixture of efgartigimod and imlifidase. We expect there’s a good case for utilizing this mixture within the rights settings we’re producing by way of medical knowledge. And as soon as we now have that knowledge set, we’ll talk about the subsequent steps with Argenx.

Within the autoimmune illness area, clearly there is a excessive variety of IgG mediated ailments with unmet medical wants. And clearly, we’re how we are able to greatest develop drug candidates on our personal, and potential in partnership with others. Within the oncology area, and I discussed this earlier within the name, we’re hematopoietic stem cell transplantation, however we actually additionally see a possible use in imlifidase as a strategy to primarily potentiate the efficacy of immuno-oncology therapies, like rituximab. We hope to have proof of mechanism sooner or later throughout this 12 months. After which, we’ll actually have a look at what the perfect method is. total, the oncology area, given the complexities and the associated fee related to working in that area, is a partnering area for us. So, clearly, we’re evaluating at what time level and in what manner we might provoke partnering within the oncology area.

Johan Unnerus

With that, can I anticipate extra actions than collaborations within the oncology area as nicely?

Søren Tulstrup

Definitely, a risk. It is a fourth leg for us. We actually see fairly some potential on this area. It is a very aggressive space, and there clearly some gamers on the market the place it might make sense to have conversations sooner or later, however that is not the place we’re at this level.

Johan Unnerus

Wonderful. Thanks a lot.

Operator

Our subsequent query comes from Zoe Karamanoli with RBC Capital Markets. Please go forward.

Zoe Karamanoli

Hello. Thanks for taking the questions. Two questions if I could. The primary one, you talked about that imlifidase gross sales can be sluggish and prolonged on a quarter-to-quarter foundation, but when we search for the complete 12 months 2022, within the presentation, you talked about that you’ve 10 precedence facilities able to tackle sufferers. So, do you assume it is life like to imagine that every of those facilities will deal with a minimal of two sufferers in 2022? And if not, I can be eager to grasp the way you assume this and what are the challenges. After which I’ve a follow-up query. Thanks.

Søren Tulstrup

Sure. So, thanks for the query, and I can’t present steerage on affected person numbers, however you are proper. We’ve got 10 facilities prepared, clinically prepared. In addition they must be commercially prepared, have particular, not simply reimbursement, however funding in place, et cetera. And they should, after all, establish the sufferers after which get the sufferers that have to have organs allotted to those particular sufferers. So, there’s a whole lot of shifting elements, and it is simply not possible for me to present you any particular indication of affected person numbers. However clearly, we anticipate this quantity, the ten facilities, to extend over the 12 months. We anticipate that – clearly, we all know that fairly a lot of these facilities have recognized sufferers already. Then, relying on organ availability, et cetera, we additionally anticipate them to have first affected person after which we’ll consider the result on that first affected person first earlier than initiating or doing a second affected person. What number of sufferers that can all add as much as, I simply can’t and won’t provide you with a steerage on this name. However I perceive that you simply’re making your calculations.

Zoe Karamanoli

Okay. Thanks. And simply as a comply with up, do you will have some targets as to what number of facilities you need to have energetic by the tip of 2022? And can you will have activated all of your tier one facilities, and the place is the most important alternative you see in Europe?

Søren Tulstrup

Sure. So, so far as the goal for facilities is anxious, it’s, as I mentioned, we now have 10 now, and I anticipate greater than 20 facilities to be clinically prepared, actually by the tip of the 12 months. We’ve got good traction throughout a lot of nations and with a lot of totally different clinics. The place will we see the most important alternatives? Properly, clearly, the amount is within the bigger nations, proper? However a few of them will take a while earlier than you get full entry. Once more, for those who have a look at a rustic like France, there’s a vital alternative. Probably, you may unlock a part of that already this 12 months with early entry program. Spain is a big total alternative, very robust curiosity from some gamers which are once more, will necessitate us getting particular entry. Clearly the UK and Germany are subsequent in line of the big nations for entry. We’ve got some very fascinating and facilities in each nations. So, I might anticipate each of those nations to be proportionally vital alternatives for us. After which, after all, you will have the early launch nations just like the Netherlands. We’ve got seven clinics which are primarily collaborating now, a few of whom are fairly prepared and really desperate to provoke and transfer additional. So, I believe I believe there’s alternative in quite a lot of nations.

Zoe Karamanoli

Thanks very a lot.

Operator

Our subsequent query comes from Dominic Rose with Intron Well being. Please go forward.

Dominic Rose

Hello. That is Dominic from Intron Well being. Thanks for taking my questions. I’ve received two. Query one is on imlifidase in bone marrow transplant. It could be a bit of early to say, however what are your present timeline expectations on this? And is there any manner you may form of speed up this system? I perceive that there are a whole lot of totally different stuff you’re doing, and it will not be a high precedence, however something you may say about what you are pondering of round that will be useful. Query two is solely how a lot of the AskBio upfront funds do you anticipate to ebook in 2022? Thanks.

Søren Tulstrup

Thanks for these two questions. So, first on the marrow transplantation, the place we’re proper now could be that we now have had dialogues with key specialists within the area, primarily within the US, but in addition in Europe. We’ve had recommendation conferences. We’ve got consulted with the FDA. There’s a lot of issues that wants additional exploration earlier than you may design type of the optimum protocol. Clearly, as I mentioned, we see vital potential total within the stem cell transplantation area. Initially, we need to concentrate on sure very critical ailments. It is also a query of managing danger and ensuring that you’ve the fitting protocol in place. And so, that is what we’re proper now. And I can’t provide you with a timeline, apart from hopefully, we’ll have the ability to, throughout this 12 months, align round a protocol after which we’ll actually – as quickly as we’re there, we’ll present additional steerage.

Dominic Rose

Second query.

Donato Spota

Sure, for the second.

Søren Tulstrup

Sure. And I am going to hand over to you, Donato. That was across the $5 million upfront.

Donato Spota

Sure. It is truly a pleasant manner of asking across the AskBio timelines, however possibly what I can say is that we anticipate to document greater than 50% this 12 months, or no less than 50% this 12 months, after which the remainder we’ll see.

Dominic Rose

Okay, effective.

Operator

Our subsequent query comes from Douglas Tsao with H.C. Wainwright. Please go forward.

Douglas Tsao

Hello. Good morning. Thanks for taking the questions and congrats on the progress, Søren. Simply possibly as a place to begin, you will have market entry procedures ongoing in, I believe you mentioned 14 nations. I am simply curious, throughout the 5 largest markets or the large 5, what number of do you assume – is it life like to assume that you simply may have the ability to launch or form of roll out commercialization in any of these markets this 12 months and what number of?

Søren Tulstrup

Sure. So, we actually hope that we’ll have optimistic outcomes within the UK and Germany. The method is shifting ahead. And as I mentioned, doubtlessly, we might have a call right here within the first half of this 12 months, enabling a launch later this 12 months. Then you will have nations like France, the place we’re actually wanting into potentialities for using the early entry program in that nation. Similar, we’re doing in another nations. However I believe full reimbursement for each Italy, Spain, and France, will seemingly come at a later stage, however clearly, you will see vital progress hopefully this 12 months, and we’ll have ongoing dialogue. So, as quickly as we’re prepared to supply extra steerage on that, we’ll try this.

Douglas Tsao

After which simply by way of – a pair questions on the pipeline. by way of the US trial inside imlifidase for kidney transplant, are you counting – I believe you indicated there are two sufferers have been enrolled within the research. Does that imply they have been transplanted or they’ve simply merely been recognized, enrolled within the research, and doubtlessly awaiting transplantation within the close to future?

Søren Tulstrup

Sure. So, what we report is after they’re enrolled, that means that we now have affected person consent they usually’ve primarily been enrolled into the research, does not imply that they’ve been transplanted. So, that is what we’ll do going ahead as nicely.

Douglas Tsao

And sometimes, what is the timeline or your expertise from the opposite trials, is that form of time between from after they enroll to truly are literally transplanted?

Søren Tulstrup

Properly, it is very tough to present you particular steerage on that. Clearly, an organ has to change into obtainable by way of the kidney allocation system. After which they’re randomized if there’s not a match. So, I can not provide you with particular knowledge there. What I can say then, we anticipate to have full enrolls by the tip of the 12 months, and that we might have knowledge by the tip of 2023. And this steerage is predicated on all of the interactions we have had with the clinics and different gamers on this area within the US.

Douglas Tsao

Okay. After which only one fast query on the NiceR program. I do know you indicated full GLP process research this 12 months, going into presumably a Part 1 research subsequent 12 months. Would you anticipate that to be a wholesome volunteer research, or simply given the character of remedy, you’d doubtlessly go into sufferers for the Idefirix Part 1b research?

Søren Tulstrup

It actually relies on the precise indication. So, I can not say at this cut-off date. So – however clearly, we have to generate sure knowledge with a brand new molecule. But it surely actually relies on the precise indication. We’re a number of indications at this cut-off date.

Douglas Tsao

And have you learnt while you’ll decide a sign for prioritized sufferers?

Søren Tulstrup

Sure. So, as soon as we now have the complete datasets and we make the evaluation, actually that is after we’ll take the precise indication. And there is a vary of areas and particular indications the place this may – or may make a whole lot of sense.

Douglas Tsao

Okay, nice. Thanks a lot.

Operator

For our subsequent query, we now have a comply with up query from Adam Karlsson with ABG. Please go forward.

Adam Karlsson

Hello. Thanks for taking my comply with. Only a query on the Genovis-Selecta announcement final quarter. I can respect you could be restricted by way of what you may say publicly right here or so. However have there been any form of formal authorized developments or escalations of that scenario? Something that you could share on that entrance could be appreciated. Thanks.

Søren Tulstrup

As you indicated your self, I imply, you will not remark particularly on anybody scenario. What I can say is that clearly, wanting on the total gene remedy area, in addition to the opposite areas we’re in, we’re very comfy with our IP place and all of the agreements we now have with varied gamers. And we’re additionally very comfy with the knowhow on the merchandise and the information and every part. So, we now have a robust place. And to the extent that that motion is critical in different fronts, that clearly will occur. And to the extent that we’ll report that’s as a result of it is related and needed. So, that is what I can let you know.

Adam Karlsson

Acquired you. Thanks.

Operator

We’ve got no additional questions. I’ll now hand again to our audio system for a closing comment.

Søren Tulstrup

Thanks very a lot, Operator. And thank everybody on your time this morning, this afternoon. Very a lot respect it. It is a very thrilling time for Hansa Biopharma. And as I mentioned, we look ahead to holding you up to date on progress. And with this, as soon as once more, thanks on your time.

Operator

Thanks. Girls and gents, this concludes the convention name. Thanks all on your participation. You might now disconnect your traces.