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Edited Transcript of HMED.ST earnings conference call or presentation 28-Apr-20 12:00pm GMT

Q1 2020 Hansa Biopharma AB Earnings Call

May 6, 2020 (Thomson StreetEvents) -- Edited Transcript of Hansa Biopharma AB earnings conference call or presentation Tuesday, April 28, 2020 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Donato Spota

Hansa Biopharma AB (publ) - CFO & Senior VP

* Søren Tulstrup

Hansa Biopharma AB (publ) - CEO

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Conference Call Participants

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* Arvid Necander

Redeye AB, Research Division - Analyst

* Christopher Winston Uhde

SEB, Research Division - Analyst

* Viktor Sundberg

ABG Sundal Collier Holding ASA, Research Division - Research Analyst

* Zoe Karamanoli

RBC Capital Markets, Research Division - Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, welcome to the Hansa Biopharma AB Interim Report for January through March 2020. (Operator Instructions) Today, I am pleased to present CEO, Søren Tulstrup. Speakers, please begin.

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [2]

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Thank you, operator. Good afternoon to those of you in Europe and good morning to those in the U.S. Welcome to the Hansa Biopharma Conference Call to discuss the first quarter results for 2020. I'm Søren Tulstrup, CEO of Hansa Biopharma. With me today, I have our CFO, Donato Spota; as well as our Head of Investor Relations, Klaus Sindahl. Today, we'll review the overall progress and highlights of the business as well as the near-term milestones. Our presentation should take about 15 minutes. And after that, we'll take your questions.

Now please turn to Slide 2. Please allow me to draw your attention to our forward-looking statements, which apply to this presentation.

Please turn to Slide 3. Hansa Biopharma's strategy to transform the organization into a fully integrated, commercial-stage global biopharmaceutical company continues according to plan. Our top priority is to get our lead compound, imlifidase, to market to enable lifesaving kidney transplants for highly sensitized patients, who are unable to access the standard-of-care treatment.

In Europe, the review process by the EMA is progressing according to plan and an opinion from the CHMP is expected in the second quarter, as previously guided. Assuming this opinion is positive, we anticipate a formal decision to be adopted by the European Commission in the third quarter of 2020. If approved, imlifidase for kidney transplantation will be the first of the drug candidates in our internal pipeline addressing conditions with high unmet medical need to receive regulatory approval, enabling the company to transform itself into a commercial-stage biopharmaceutical company.

In the U.S., we are currently in close discussions with the FDA on the design of the randomized control trial for kidney transplantation. The interaction with the FDA is progressing according to plan and we expect to submit the study protocol in the second quarter. Once the protocol is formally approved, we expect to set up the specific trial centers in the U.S. and apply for the necessary ethical approvals. Recruitment of the (inaudible) targeted for the fourth quarter of this year. Back in March, at the Cutting Edge of Transplantation Summit in Phoenix, Arizona, Hansa Biopharma presented long-term follow-up data, demonstrating a 2-year graft survival rate of 89% after imlifidase treatment and transplantation in 27 patients from the Phase II trials.

We're very encouraged by the long-term follow-up data in these highly sensitized patients, which mirrors the outcome in the broader transplantation patient population that includes less challenging-to-treat patients. We continue to advance our pipeline across our clinical programs, having completed enrollment in our anti-GBM Phase II study and continuing enrollment of patients in our Phase II AMR and GBS studies.

Following the recent completion of enrollment in the anti-GBM study led by principal investigator, professor Mårten Segelmark, we anticipate announcing high level data in the third quarter of this year. An exciting and potentially transformative year lies ahead of us. However, the COVID-19 pandemic imposes certain additional challenges to us as a company. During the past 2 months, the company has taken measures to protect our colleagues and take social responsibility while attempting to limit negative effects on our business.

It is now too early to fully assess the potential negative impact that the pandemic will have on Hansa Biopharma. We do believe, however, that we may see potential effects of COVID-19, particularly with respect to recruitment timelines in AMR and GBS, the timing of the initiation of our new U.S. imlifidase trial as well as activities related to the potential European launch.

Now please turn to Slide 4. At Hansa Biopharma, our short-term priority is to advance our lead drug candidate, imlifidase, to market authorization to enable kidney transplants for highly sensitized patients. In Europe, the review process is on track. At the end of the first quarter, the responses to the day 180 questions were submitted, and we expect a formal adoption of outstanding questions at the April CHMP session, which is ongoing as we speak.

Throughout the review process, we've had positive and constructive discussions with EMA with frequent interactions over the past year. We're now in the final process of addressing the outstanding questions, including the commission of patients and design of the post-approval study. Following a final adoption of the list of the outstanding questions, we expect a CHMP opinion coming out of the subsequent CHMP meeting here in the second quarter. Assuming the opinion is positive, a potential conditional approval by the European Commission is possible in the third quarter. We're very excited about a potential near-term approval and commercialization in Europe. We do, however, acknowledge that the potential launch may be affected by the COVID-19 pandemic due to limited opportunities to engage with market access authorities. This could potentially delay pricing and reimbursement discussions in some of our early-launch countries.

Our immediate goal remains to launch imlifidase in the first clinics this year. As communicated previously, our European launch strategy involves targeting leading kidney transplantation centers with the potential to become early adopters and centers of reference.

Now please turn to Slide 5. In the U.S., the discussions with the FDA on the design of the new trial in kidney transplantation is progressing according to plan. The new trial is expected to include approximately 50 patients with a cPRA score of 99.9% or above. eGFR, which is a measure for kidney function, will be used as a surrogate endpoint after 12 months to demonstrate a clinical benefit of imlifidase therapy versus patients on the waitlist for kidney transplant.

Submission of the study protocol is expected here in the second quarter. The results from this new clinical study could support BLA filing in the U.S. by 2023 under the accelerated approval pathway. Obviously, we'll do what we can to compress this process and timeline as much as possible. We aim to commence recruitment in Q4 2020, following receipt of the necessary ethical approvals and the setting up of trial centers in the U.S. However, we acknowledge the risk of potential timeline impact due to the COVID-19 pandemic, which is affecting priority setting by the FDA.

Please turn to Slide 6. Beyond kidney transplantation, we have made solid progress across our pipeline and platform activities over the last 12 months. In anti-GBM, we completed the enrollment in investigator-initiated Phase II study run by professor Mårten Segelmark by the end of January. A total of 15 patients were enrolled across 5 countries in Europe, and we expect the first data readout during the third quarter of 2020. Anti-GBM is an ultra-rare disease affecting approximately 1.6 in 1 million people globally per year, where the immune system mistakenly develops IgG antibodies resulting in acute immunologic attack. As a consequence of the attack, the majority of patients lose their kidney function and end up in chronic dialysis, waiting for potential kidney transplantation.

The aim of the study is to evaluate safety and tolerability of imlifidase and assess the efficacy based on renal function at 6 months post-treatment. In acute antibody-mediated rejection, also known as AMR, we have now included 4 out of 30 patients in our Phase II study with imlifidase for the treatment of acute AMR after kidney transplantation.

Active AMR episodes occur in 10% to 15% of kidney transplant patients and remain a significant medical challenge that can lead to loss of graft function. Today, there is no approved therapy for the treatment of active AMR in heart, lung and kidney transplants. As highlighted early on the call, we expect that our recruitment timelines and clinical programs will be affected negatively by 3 to 6 months due to the COVID-19 pandemic. Enrollment in AMR is now expected to be completed in the first half of 2021.

In Guillain-Barré syndrome, also known as GBS, 4 patients out of targeted 30 patients have been enrolled in our Phase II study. This is our second Phase II study outside of transplantation and marks the continued expansion of our enzyme platform into autoimmune diseases. Our GBS study is an open-label, single-arm multicenter trial evaluating the safety, tolerability and efficacy of imlifidase in combination with standard of care IVIg. Following the impact of the COVID-19 pandemic, we now expect to complete the enrollment in GBS study in the second half of 2021, which is a 3- to 6-month delay compared to the timeline indicated previously.

Now please turn to Slide 7 and a summary overview of our pipeline. As depicted on this overview slide, thanks to continued progress over the past years, we have now developed broad clinical pipeline in both transplantation and autoimmune diseases, and we have exciting preclinical projects ongoing in cancer and anti-drug antibodies.

I will now hand over the call to Donato, who will walk us through the financials. Donato?

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Donato Spota, Hansa Biopharma AB (publ) - CFO & Senior VP [3]

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Thank you, Søren. Please turn to Slide 8. The progress we made in advancing our business, as Søren just outlined, it is also reflected in the investments in our pipeline and in the continued commercial preparations during the first quarter of this year. In the first quarter, our SG&A expenses amounted to SEK 39 million compared to SEK 29 million of last year, as we continue to expand our activities related to marketing, branding, market access and supply chain in preparation for a potential commercial launch of imlifidase in Europe later this year. Our investments in R&D amounted to SEK 53 million in the first quarter, which is up SEK 10 million from a year ago.

Progressing our R&D programs and our medical expense activities were the main drivers for the increase. The net loss for the first quarter of 2020 amounted to SEK 93 million compared to SEK 72 million for the same period of last year.

Please turn to Slide 9. Cash flow from operating activities amounted to minus SEK 121 million in quarter 1 compared to minus SEK 102 million for the same period a year ago.

At the end of March, our cash position, including short-term investments, amounted to SEK 477 million, which is equivalent to approximately USD 47 million. We expect this amount to finance operations through mid-2021.

With this, I hand back to Søren to give his final remarks.

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [4]

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Thank you, Donato. Please turn to Slide 10. Throughout the past year, we continued to show solid progress across both our pipeline and platform-building activities. The organization has also expanded as we continue preparing for the potential launch of imlifidase in Europe. We're looking ahead to further advancement with many important milestones in 2020 and the years to come. Assuming the EMA review process progresses as expected, we anticipate a CHMP opinion in the second quarter. Following a potential conditional approval by the European Commission in the third quarter, we aim to launch imlifidase in the first clinics later this year.

In the third quarter of this year, we should also have the first data readout from the completed anti-GBM study. The readout from this Phase II trial will be the first high-level set of complete data from a study outside transplantation and will mark Hansa's continued advancement into new indications and for critical areas beyond transplantation. Lastly, we have slightly revised the timelines for the completion of enrollment in both the AMR and GBS Phase II trials due to the expected impact from the COVID-19 pandemic.

In summary, 2020 will be an exciting year for Hansa Biopharma, and we look forward to keeping you updated on the progress of our journey as we transform the company into a fully integrated, commercial stage biopharmaceutical company that brings lifesaving and life-altering therapies to patients with rare diseases and generates long-term value to our shareholders and society at large.

Please turn to Slide 11. With this, we are now ready to take your questions. Operator, please begin.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Christopher Uhde of SEB.

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Christopher Winston Uhde, SEB, Research Division - Analyst [2]

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Well, it's interesting times, obviously, with COVID. And so I guess if you could give a bit more detail on exactly how you see it impacting recruitment? I mean, there's obviously a bunch of different levels where it could be, right? I mean, patients who are less willing to seek treatment, clinicians who are less willing to put them into trials or just less willing to work with sponsors in general? I mean, what can you tell us about that landscape right now for you?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [3]

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Yes. I would say that the main effect the COVID-19 pandemic has on patient recruitment, really, is due to limited ability to interact with the trial centers and also reprioritizations within the trial centers. Clearly, they need to be top of mind if you are to uphold an ongoing recruitment rate. And since we have now somewhat limited ability to interact on an ongoing basis, certainly, physically, but even virtually, that does impact, again, the ability of the centers to enroll patients.

Also, clearly, patients themselves have to stick to local guidelines and policies and regulations and so on. And so their ability to actually travel to and be admitted into hospitals is being impacted by the COVID-19 pandemic and the associated steps taken by different countries. So it's really a mixture of that.

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Christopher Winston Uhde, SEB, Research Division - Analyst [4]

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Yes. I mean, I guess -- because obviously, these are still areas of pretty high unmet need, right? So then they will still need therapy and -- yes, transplantations and so on. I mean, what can -- I mean, I guess there's still got to be some will to continue with this on the part of the site. So how can you...

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [5]

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Absolutely.

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Christopher Winston Uhde, SEB, Research Division - Analyst [6]

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How can you kind of go about trying to mitigate the effects, let's say?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [7]

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Well, it is to be in as close a dialogue as possible with the trial centers and decision makers and influencers. And as you just said very rightly, the diseases that we're investigating imlifidase for are very difficult and life-threatening diseases. And so that in itself, I think, helps us in this situation. But clearly, as you can imagine, many hospitals are under severe duress during this first critical phase of the pandemic. And so that has impacted, again, the way that they operate and set priorities internally and then their ability to dialogue with partners outside of the hospital. But clearly, given the fact that these are very serious diseases and that we have good relationships, we expect a temporary impact, but not a long-term impact. And we might be able to recoup some of the time lost later.

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Christopher Winston Uhde, SEB, Research Division - Analyst [8]

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Okay. Great. And then -- I mean, so to date, would you say that you've already felt the impact in the AMR and GBS trials? Or you think it's more yet to come?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [9]

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So what typically happens when you start up these trials, and we're still in the early phase here, is that it's kind of a snowball effect or catch up effect, if you will, that it takes a little while to get going, and then you see a sudden uptick in the enrollment rate. And that has to do really with this becoming top of mind and part of standard procedures and so on. And now you have this kind of [insulation], or pause, if you will. And so we haven't really seen a dramatic impact in terms of the patient numbers compared to the timeline. It's more a question of now there is this pause, if you will, and it will take some time to restart and you do lose momentum. So that is the critical impact.

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Christopher Winston Uhde, SEB, Research Division - Analyst [10]

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Okay. Got it. And then on the second area, it's just on the launch. So how many staff do you plan to add to the team now for the actual market access, and yes, sales?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [11]

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Yes. So you're talking about the front-end personnel. So right now, what we have essentially is medical personnel. We have MSLs. We have a handful in Europe at this point in time. As we get closer to the launch, we will add more key account management-type personnel. We will only need to do that pretty close to the launch time. As you probably know, not a lot of innovation has happened in transplantation space and so there is quite a lot of good, talented experience people out there that we can onboard fairly quickly. And so we don't need to do that well in advance. And overall, if you look down the road, when we have launched, we're further down in the launch path, and we've launched in several countries and so on. We're talking low double-digit numbers. So it's not a high number.

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Christopher Winston Uhde, SEB, Research Division - Analyst [12]

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So I mean do you -- I mean, do you need to get people who are going to be on-site full time? I mean, will they be dedicated to one specific site since it's such a limited launch initially? And are these basically mostly going to be MDs? Or is that not necessary?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [13]

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So definitely, we're looking to hire. We already have hired quite a number of excellent people with experience. We're looking to hire people with high degrees of qualification. This is a scientific launch, if you will. You're dealing with very experienced centers. And what we do intend to do is, as we talked to previously, is to go center-by-center initially, really focus on the early adopters and those who are most likely to produce positive outcomes. And there, you can kind of have a task force approach, if you will, a tight-knitted group that you move from one center to another, even across borders, to a certain extent. But over time, you will have people who are more associated with a single center or a number of individual centers.

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Operator [14]

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Our next question comes from the line of Viktor Sundberg of ABG Sundal Collier.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Research Division - Research Analyst [15]

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So you stated in today's report that you submitted the day 180 responses to EMA for review. Does that formally mean that you now have left the second clock stop and that the clock is ticking, if you will, until you receive opinion after 210 active days?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [16]

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Yes, that's correct. There is a 1-month clock stop at the end of day 180. And so we provided our responses within that clock-stop window. And so now the process is running again essentially. But then, of course, you have a process ongoing, and then you have the rapporteur and the co-rapporteur who have dealt with us initially. And now they're getting and have been getting input from the other member states, and that's all being consolidated. And as we then communicated, we expect that the list of outstanding questions following our responses will now be formally adopted at the current session -- CHMP session here in April.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Research Division - Research Analyst [17]

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And could you give some more flavor what it means that these questions are adopted? Is that you mean they are...

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [18]

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Yes, this means that then there is a formal list of outstanding questions that should be addressed by the applicant. Obviously, within close dialogue with relevant parties at EMA and within CHMP and so on. And so we're broadly -- we're aware of that. At least, this draft setup, it has to be formally adopted and approved as a formal list of outstanding questions that we need to respond to. And we've already commenced responding to the questions contained in the draft version.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Research Division - Research Analyst [19]

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Yes. And could you also comment if you have been requested to attend an oral explanation to address any outstanding issues in front of the CHMP? Or has it just been written communication?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [20]

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So you always have to plan for that in advance. The agenda has actually not been, last I checked, confirmed by CHMP. They typically do that on the first day, so that should be today, but I haven't seen the final agenda. So I can't say whether it is on the agenda or not.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Research Division - Research Analyst [21]

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Okay. Yes. And just a final question. Looking at your cash position, it seems that you have an increased cash burn in this quarter. And it looks like with that cash burn, that cash will run out before mid-2021. So how should we think about that negative SEK 121 million for this quarter? And how we should extrapolate that going forward?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [22]

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Well, there's some time. I'll let Donato answer this. Donato?

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Donato Spota, Hansa Biopharma AB (publ) - CFO & Senior VP [23]

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Yes, sure. This is Donato speaking. Yes, I think this is in accordance with our planning, and the guidance that we've given is accurate. If you look, for example -- I don't know if you still have it in front of you -- but if you look on Slide 9, you can also see first quarter of '19 has a bit of a higher cash burn compared to the following quarters. I think that's just typical. You have the effect from the December on previous year, which is basically only a 2-week -- months and so a number of payments shift into the first quarter, and then you have some other one-off payments that you typically have in the first quarter where you pay invoices, which is related to a full year cost, et cetera. So that's not unplanned, and it's actually in line with what you have seen in the past.

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Operator [24]

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Our next question comes from the line of Zoe Karamanoli of RBC Capital Markets.

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Zoe Karamanoli, RBC Capital Markets, Research Division - Analyst [25]

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Just one follow-up clarification on the previous question about the CHMP process. Is the decision typically announced at the end of the CHMP meeting immediately, like, on the same-day or it could be a few days after?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [26]

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So what typically happens is the CHMP session is usually a 4-day session. This time, it's a 3-day session because of the holiday. But usually, it's a 4-day session, and they announced highlights on the Friday of that week. And the highlights only contain opinions, withdrawals, reexaminations, and so on; so very, very limited. And then you have the minutes. Obviously, they will only be announced after the subsequent CHMP meeting at the earliest. And I think currently, there is actually a backlog. But the key decisions, I just talked to which ones those are, will be announced typically on the Friday. But again, it really depends on -- if there is a holiday, I think, this week, you have a -- it's the 1st of May, which is a holiday in some countries and so on, so I don't know specifically when.

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Zoe Karamanoli, RBC Capital Markets, Research Division - Analyst [27]

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Okay. That's very useful. And then I have few more questions. So going back to the COVID-19 impact, has this impact your launch preparations with regards to your strategy and which countries you will target and approach first?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [28]

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No, not really. So we are clearly going center-by-center. We have identified the centers that are most likely to become early adopters. And those were -- given their competencies and resources and experience -- they are most likely to have or generate positive experiences early on. And that -- we, of course, pair with an underlying matrix of early-launch countries versus later-launch countries from a pricing and reimbursement perspective. And it's too early to say really at this point in time whether there's going to be a particular delay in any one country.

So we've just said that if we look at how the COVID-19 pandemic could potentially impact our business, clearly, there might be some impact as to the timing of pricing and reimbursement decisions. But we can't say at this point in time, specifically how or even if it will have any impact at all.

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Zoe Karamanoli, RBC Capital Markets, Research Division - Analyst [29]

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Okay. And my second question is about the U.S. trial and the regulatory pathway. Do you have any plans? Or are you allowed to file for a breakthrough therapy designation?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [30]

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Yes, we can apply for breakthrough therapy designation essentially at any point in time, and it's certainly something we are considering. We do have fast-track designation, and that gives us a lot of the things that you really want, essentially, including ongoing submission of application, data and so on. What breakthrough therapy designation gives you is formal involvement of senior FDA personnel, which is, to a certain extent, something we already have. But we are considering it, whether it might make sense or not; and we can submit that application at any point in time.

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Operator [31]

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Our next question comes from the line of [David Hedden] of Rx Securities.

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Unidentified Analyst [32]

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Just going back to the CHMP process. With your responses to day 180 questions, can you just give us a flavor for the content of the day 180 questions. Was there anything similar to the day-120 that perhaps they felt wasn't quite addressed? And then after the day 120 questions, you said you were satisfied with the responses. Again, how confident are you in response to the day 180?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [33]

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Well, I'm not going to go into all of the details around the questions and the responses that we provided. As I said, the dialogue broadly is around identification of the ideal patients, i.e., those patients with the highest degree of unmet medical need who would benefit the most from this therapy; as well as the design of the post-approval study. And as you can imagine, you have a dialogue with the rapporteurs and then you involve a broader group of people and so on. And based on that, you then come up with this final list. And that contains, broadly speaking, questions that we're comfortable addressing. And as I said, we are already in the process of addressing these questions so that the CHMP may move ahead within the timeline that we have indicated.

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Unidentified Analyst [34]

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Okay. Great. And then just on the anti-GBM study, with the results -- initial results coming up. I'm just wondering how we can find success of that study and what you would expect typically in the patient population treated with standard of care? What proportion of patients do you want to see dialysis-free?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [35]

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Well, today, essentially, 2 out of every 3 patients end up in dialysis. Now whether they do that or not, depends on a number of different factors, including when they're diagnosed, and of course, the effect of therapy and so on. I'm not in a position and we haven't defined a kind of clear cut number that would indicate that this is a successful look at the totality of data, totality of results, together with the investigators, and determine what this indicates and what would be the next steps for this potential indication.

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Operator [36]

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(Operator Instructions) The next question comes from the line of Arvid Necander of Redeye.

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Arvid Necander, Redeye AB, Research Division - Analyst [37]

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And so looking at COVID from a bit of a different angle, I guess, there's been more and more evidence presented showing a link between COVID-19 and GBS. The article in New England Journal of Medicine received quite a bit of traction, I guess. How do you view these reports? And is this an opportunity that you're planning on addressing?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [38]

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Yes, you're correct. There has been a report recently featured in New England Journal of Medicine, a report from Northern Italy on the number of patient cases where clearly there is a suspected link between the SARS-CoV-2 virus and subsequent sort of GBS. And that has actually also previously been reported in The Lancet based on some patient data in China. And it's very possible that there is a link between SARS-CoV-2 and GBS. As you know, GBS is triggered by an infection, and a number of viruses have been associated with it, including some with corona background, so it's certainly very possible.

And now what does that mean? Given the contagiousness of this particular virus, clearly, if there is such a connection, you would expect quite a number of people to be potentially exposed, if you will, to the virus and potentially, you might see some spillover to GBS. But at this point in time, it's just too early to speculate. But clearly, it's something we're looking at, and we are also considering how to discuss this with the regulatory authorities.

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Arvid Necander, Redeye AB, Research Division - Analyst [39]

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Okay. Yes. And then my second question concerns the regulatory path in Europe. So considering you're in discussions with EMA and also assuming a conditional approval, can you say anything about your expectations for the trial design in the following -- in the post-approval study that will follow that? Do you expect it to have the same -- do you expect the patient recruitment to be about the same as in the U.S. pivotal trial? Is it possible that it could be a randomized trial as well? And yes, what are your expectations?

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [40]

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I'd like to say, I mean, as I just indicated, this is actually being discussed now. It's part of our dialogue, it is one of the questions or a number of questions that we're addressing. And so I think we should just wait and see once the CHMP weighs in, then we'll have essentially the result. There is a number of different trial designs that could be implemented. And I think at this point in time, we should just wait and see what will be the final decision.

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Operator [41]

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Okay. There seems to be no further questions on the line at this time, so I hand back to our speakers for the closing comments.

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Søren Tulstrup, Hansa Biopharma AB (publ) - CEO [42]

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Well, thank you very much, everyone, for your interest and time today. We have a very exciting period ahead of us, and I look very much forward to keeping you informed. So with this, thank you so much. Bye-bye.