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

Following the latest completion of enrollment within the anti-GBM research led by principal investigator, Professor Mårten Segelmark, we anticipate asserting excessive degree knowledge within the third quarter of this 12 months. An thrilling and doubtlessly transformative 12 months lies forward of us. Nonetheless, the COVID-19 pandemic imposes sure further challenges to us as an organization. Through the previous 2 months, the corporate has taken measures to guard our colleagues and take social duty whereas making an attempt to restrict damaging results on our enterprise.

It’s now too early to totally assess the potential damaging influence that the pandemic can have on Hansa Biopharma. We do imagine, nonetheless, that we might even see potential results of COVID-19, notably with respect to recruitment time strains in AMR and GBS, the timing of the initiation of our new U.S. imlifidase trial in addition to actions associated to the potential European launch.

Now please flip to Slide 4. At Hansa Biopharma, our short-term precedence is to advance our lead drug candidate, imlifidase, to market authorization to allow kidney transplants for extremely sensitized sufferers. In Europe, the evaluation course of is on observe. On the finish of the primary quarter, the responses to the day 180 questions had been submitted, and we count on a proper adoption of excellent questions on the April CHMP session, which is ongoing as we communicate.

All through the evaluation course of, we have had optimistic and constructive discussions with EMA with frequent interactions over the previous 12 months. We’re now within the remaining technique of addressing the excellent questions, together with the fee of sufferers and design of the publish approval research. Following a remaining adoption of the record of the excellent questions, we count on a CHMP opinion popping out of the next CHMP assembly right here within the second quarter. Assuming the opinion is optimistic, a possible conditional approval by the European Fee is feasible within the third quarter. We’re very excited a couple of potential near-term approval and commercialization in Europe. We do, nonetheless, acknowledge that the potential launch could also be affected by the COVID-19 pandemic as a result of restricted alternatives to have interaction with market entry authorities. This might doubtlessly delay pricing and reimbursement discussions in a few of our early launched nations.

Our speedy purpose stays to launch imlifidase within the first (inaudible) this 12 months. As communicated beforehand, our European launch technique entails concentrating on main kidney transplantation facilities with the potential to grow to be early adopters and facilities of reference.

Now please flip to Slide 5. Within the U.S., the discussions with the FDA on the design of the brand new trial in kidney transplantation is progressing based on plan. The brand new trial is anticipated to incorporate roughly 50 sufferers with a cPRA rating of 99.9% or above; eGFR, which is a measure for kidney operate can be used as a surrogate endpoint after 12 months to display a scientific advantage of imlifidase remedy versus sufferers on the waitlist for kidney transplant. Submission of the research protocol is anticipated right here within the second quarter. The outcomes from this new scientific research may assist a BLA submitting within the U.S. by 2023 underneath the accelerated approval pathway. Clearly, we’ll do what we are able to to compress this course of and time line as a lot as potential. We intention to start recruitment in This autumn 2020, following receipt of the required moral approvals and the setting out of trial facilities within the U.S. Nonetheless, we acknowledge the danger of potential time line influence because of the COVID-19 pandemic, which is affecting precedence setting by the FDA.

Please flip to Slide 6. Past kidney transplantation, we have now made strong progress throughout our pipeline and platform actions during the last 12 months. In anti-GBM, we accomplished the enrollment in investigator-initiated Section II research run by Professor Mårten Segelmark by the top of January. A complete of 15 sufferers had been enrolled throughout 5 nations in Europe, and we count on the primary knowledge readout throughout the third quarter of 2020. Anti-GBM is an ultra-rare illness affecting roughly 1.6 in 1 million individuals globally per 12 months, the place the immune system mistakenly develops IgG antibodies leading to acute immunologic assault. As a consequence of the assault, nearly all of sufferers lose their kidney operate and find yourself in continual dialysis ready for potential kidney transplantation.

The intention of the research is to guage security and tolerability of imlifidase and assess the efficacy based mostly on renal operate at 6 months publish therapy. In acute antibody-mediated rejection, also called AMR, we have now now included Four out of 30 sufferers in our Section II research with imlifidase for the therapy of acute AMR after kidney transplantation.

Lively AMR episodes happen in 10% to 15% of kidney transplant sufferers and stay a major medical problem that may result in lack of graft operate. At this time, there is no such thing as a permitted remedy for the therapy of energetic AMR in coronary heart, lung and kidney transplants. As highlighted early on the decision, we count on that our recruitment time strains and scientific packages can be affected negatively by Three to six months because of the COVID-19 pandemic. Enrollment in AMR is now anticipated to be accomplished within the first half of 2021.

In Guillain-Barré syndrome, also called GBS, Four sufferers out of focused 30 sufferers have been enrolled in our Section II research. That is our second Section II research exterior of transplantation and marks the continued enlargement of our enzyme platform into odd ailments. Our GBS research is an open-label, single-arm multicenter trial evaluating the security, tolerability and efficacy of imlifidase together with commonplace of care IVIg. Following the influence of the COVID-19 pandemic, we now count on to finish the enrollment in GBS research within the second half of 2021, which is a 3- to 6-month delay in comparison with the time line indicated beforehand.

Now please flip to Slide 7 and a abstract overview of our pipeline. As depicted on this overview slide, due to continued progress over the previous years, we have now now developed broad scientific pipeline in each transplantation and odd ailments, and we have now thrilling preclinical tasks ongoing in most cancers and anti-drug antibodies. I’ll now hand over the decision to Donato, who will stroll us by means of the financials. Donato?

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

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Thanks, Søren. Please flip to Slide 8. The progress we made in advancing our enterprise, as Søren simply outlined, it is usually mirrored in investments in our pipeline and within the continued industrial preparations throughout the first quarter of this 12 months. Within the first quarter, our SG&A bills amounted to SEK 39 million in comparison with SEK 29 million final 12 months as we proceed to broaden our actions associated to

advertising, branding, market entry and provide chain in preparation for a possible industrial launch of imlifidase in Europe later this 12 months. Our investments in R&D amounted to SEK 53 million within the first quarter, which is up SEK 10 million from a 12 months in the past.

Progressing our R&D packages and our medical expense actions had been the primary drivers for the rise. The web loss for the primary quarter of 2020 amounted to SEK 93 million in comparison with SEK 72 million for a similar interval of final 12 months.

Please flip to Slide 9. Money move from working actions amounted to minus SEK 121 million in quarter 1 in comparison with minus SEK 102 million for a similar interval a 12 months in the past.

On the finish of March, our money place, together with short-term investments, amounted to SEK 477 million, which is equal to roughly USD 47 million. We count on this quantity to finance operations by means of mid-2021.

With this, I hand again to Søren to provide his remaining remarks.

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

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Thanks, Donato. Please flip to Slide 10. All through the previous 12 months, we continued to point out strong progress throughout each our pipeline and platform constructing actions. The group has additionally expanded as we proceed getting ready for the potential launch of imlifidase in Europe. We’re waiting for additional development with many necessary milestones in 2020 and the years to return. Assuming the MAA evaluation course of progresses as anticipated, we anticipate a CHMP opinion within the second quarter. Following a possible conditional approval by the European Fee within the third quarter, we intention to launch imlifidase within the first clinics later this 12 months.

Within the third quarter of this 12 months, we must also have the primary knowledge readout from the finished anti-GBM research. The readout from this Section II trial would be the first excessive degree set of full knowledge from a research exterior transplantation and can mark Hansa’s continued development into new indications and for essential areas past transplantation. Lastly, we have now barely revised the timelines for the completion of enrollment in each the AMR and GBS Section II trials because of the anticipated influence from the COVID-19 pandemic.

In abstract, 2020 can be an thrilling 12 months for Hansa Biopharma, and we stay up for conserving you up to date on the progress of our journey as we rework the corporate into a totally built-in, industrial stage biopharmaceutical firm that brings lifesaving and life-altering therapies to sufferers with uncommon ailments and generates long-term worth for our shareholders and society at giant.

Please flip to Slide 11. With this, we are actually able to take your questions. Operator, please start.

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Questions and Solutions

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Operator [1]

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(Operator Directions) Our first query comes from the road of Christopher Uhde of SEB.

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Christopher Winston Uhde, SEB, Analysis Division – Analyst [2]

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Nicely, it is fascinating instances, clearly, with COVID. And so I assume in the event you may give a bit extra element on precisely the way you see it impacting recruitment? I imply, there’s clearly a bunch of various ranges the place it may very well be, proper? I imply, sufferers who’re much less keen to hunt therapy, clinicians who’re much less keen to place them into trials or simply much less keen to work with sponsors typically? I imply, what are you able to inform us about that panorama proper now for you?

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

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Sure. I’d say that the primary impact the COVID-19 pandemic has on affected person recruitment, actually, is because of restricted means to work together with the trial facilities and likewise repatriations throughout the trial facilities. Clearly, they must be high of thoughts if you’re to uphold an ongoing recruitment charge. And since we have now now considerably restricted means to work together on an ongoing foundation, actually, bodily, however even nearly, that does influence, once more, the power of the facilities to enroll sufferers.

Additionally, clearly, sufferers themselves have to stay to native tips and insurance policies and rules and so forth. And so their means to truly journey to and be admitted into hospitals is being impacted by the COVID-19 pandemic and the related steps taken by totally different nations. So it is actually a combination of that.

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Christopher Winston Uhde, SEB, Analysis Division – Analyst [4]

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Sure. I imply, I assume — as a result of clearly, these are nonetheless areas of fairly excessive unmet want, proper? So then they’ll nonetheless want remedy and — sure, transplantations and so forth. I imply, what can — I imply, I assume there’s nonetheless obtained to be some will to proceed with this on the a part of the positioning. So how will you…

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

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Completely.

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Christopher Winston Uhde, SEB, Analysis Division – Analyst [6]

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How will you form of go about attempting to mitigate the consequences, as an example?

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

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Nicely, it’s to be in as shut a dialogue as potential with the trial facilities and resolution makers and influencers. And as you simply stated very rightly, the ailments that we’re investigating imlifidase for are very tough and life-threatening ailments. And in order that in itself, I believe, helps us on this scenario. However clearly, as you possibly can think about, many hospitals are underneath extreme duress throughout this primary essential part of the pandemic. And in order that has impacted, once more, the best way that they function and set priorities internally and their means to dialogue with companions exterior of the hospital. However clearly, given the truth that these are very critical ailments and that we have now good relationships we count on a brief influence, however not a long-term influence. And we’d have the ability to recoup a few of the time misplaced later.

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Christopher Winston Uhde, SEB, Analysis Division – Analyst [8]

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Okay. Nice. After which — I imply, so so far, would you say that you have already felt the influence within the AMR and GBS trials? Otherwise you assume it is extra but to return?

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

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So what usually occurs while you begin up these trials, and we’re nonetheless within the early part right here, is that it is form of a snowball impact or catch up impact, if you’ll, that it takes a short time to get going, and then you definately see a sudden uptick within the enrollment charge. And that has to do actually with this turning into high of thoughts and a part of commonplace procedures and so forth. And now you may have this sort of (inaudible), if you’ll. And so we’ve not actually seen a dramatic influence by way of the affected person numbers in comparison with the timeline. It is extra a query of now there may be this pause, if you’ll, and it’ll take a while to restart and also you do lose momentum. So that’s the essential influence.

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Christopher Winston Uhde, SEB, Analysis Division – Analyst [10]

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Okay. Acquired it. After which on the second space, it is simply on the launch. So what number of steps do you intend so as to add to the group now for the precise market entry and sure, gross sales?

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

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Sure. So that you’re speaking concerning the entrance finish personnel. So proper now, what we have now primarily is medical personnel. Now we have MSLs. Now we have a handful in Europe at this time limit. As we get nearer to the launch, we are going to add extra key account administration kind personnel. We’ll solely want to try this fairly near the launch time. As you most likely know, not numerous innovation has occurred in transplantation house and so there may be various good gifted expertise individuals on the market that we are able to onboard pretty rapidly. And so we do not want to try this nicely upfront. And general, in the event you look down the street, when we have now launched, we’re additional down within the launch path, and we have launched in a number of nations and so forth. We’re speaking low double-digit numbers. So it isn’t a excessive quantity.

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Christopher Winston Uhde, SEB, Analysis Division – Analyst [12]

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So I imply do you — I imply, do that you must get people who find themselves going to be on-site full time? I imply, will they be devoted to 1 particular web site because it’s such a restricted launch initially? And are these principally largely going to be MDs? Or is that not mandatory?

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

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So undoubtedly, we’re seeking to rent. We have already got employed fairly various glorious individuals with expertise. We’re seeking to rent individuals with excessive levels of qualification. It is a scientific launch, if you’ll, you are coping with very skilled facilities. And what we do intend to do is, as we talked to beforehand, is to go middle by middle initially, actually give attention to the early adopters and those that are most definitely to provide optimistic outcomes. And there, you possibly can form of have a job power method, if you’ll, a decent knitted group that you simply transfer from one middle to a different, even throughout borders, to a sure extent. However over time, you’ll have people who find themselves extra related to a single middle over various particular person facilities.

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Operator [14]

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Our subsequent query comes from the road of Viktor Sundberg of ABG Sundal Collier.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Analysis Division – Analysis Analyst [15]

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So that you acknowledged in at the moment’s report that you simply submitted the day 180 responses to AMR for evaluation. Does that formally imply that you simply now have left the second clock cease and that the clock is ticking, if you’ll, till you obtain opinion after 210 energetic days?

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

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Sure, that is appropriate. There’s a 1-month clock cease on the finish of day 180. And so we supplied our responses inside that clock cease window. And so now the method is working once more primarily. However then, in fact, you may have a course of ongoing, after which you may have the rapporteur and the co-rapporteur who’ve handled us initially. And now they’re getting and have been getting enter from the opposite member states, and that is all being consolidated. And as we then communicated, we count on that the record of excellent questions following our responses will now be formally adopted on the present session — CHMP session right here in April.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Analysis Division – Analysis Analyst [17]

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And will you give some extra taste what it signifies that these questions are adopted? Is that you simply imply they’re…

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

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Sure, which means that then there’s a formal record of excellent questions that ought to be addressed by the applicant. Clearly, inside an in depth dialogue with related events at EMA and inside CHMP and so forth. And so we’re broadly — we’re conscious of that, no less than on this draft setup, it needs to be formally adopted and permitted as a proper record of excellent questions that we have to reply to. And we have already commenced responding to the questions contained within the draft model.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Analysis Division – Analysis Analyst [19]

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Sure. And will you additionally remark if in case you have been requested to attend an oral clarification to handle any excellent points in entrance of the CHMP? Or has it simply been written communication?

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

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So that you at all times need to plan for that upfront. The agenda has really not been — final I checked, been confirmed by CHMP. They usually try this on the primary day, in order that ought to be at the moment, however I have never seen the ultimate agenda, so I can not say whether or not it’s on the agenda or not.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Analysis Division – Analysis Analyst [21]

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Okay. Sure. And only a remaining query. your money place, it appears that you’ve got an elevated money burn on this quarter. And it appears to be like like with that money burn, that money will run out earlier than mid-2021. So how ought to we take into consideration that damaging SEK 121 million for this quarter? And the way we should always extrapolate that going ahead?

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

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Nicely, that is a while — I am going to let Donato reply this. Donato?

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

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Sure, positive. That is Donato talking. Sure, I believe that is in accordance with our planning and the steering that we have given is correct. Should you search for instance, I do not know in the event you nonetheless have it in entrance of you, however in the event you look on Slide 9, you may also see first quarter of ’19 has a bit of a better money burn in comparison with the next quarters. I believe that is simply typical. You will have the impact from the December, earlier 12 months, which is principally solely a 2-week — months and so various funds shift into the primary quarter, after which you may have another one-off funds that you simply usually have within the first quarter the place you pay invoices, which is expounded to a full 12 months value, et cetera. In order that’s not unplanned, and it is really in step with what you may have seen previously.

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Operator [24]

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Our subsequent query comes from the road of Zoe Karamanoli of RBC Capital Markets.

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Zoe Karamanoli, RBC Capital Markets, Analysis Division – Analyst [25]

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Only one follow-up clarification on the earlier query concerning the CHMP course of. Is the choice usually introduced on the finish of the CHMP assembly instantly — like, on the same-day or it may very well be a couple of days after?

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

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So what usually occurs is the CHMP session is often a 4-day session. This time, it is a 3-day session due to the vacation. However often, it is a 4-day session, and so they introduced highlights on the Friday of that week. And the highlights solely comprise opinions, withdrawals, reexaminations and so forth, so very, very restricted. After which you may have the minutes. Clearly, they’ll solely be introduced after the next CHMP assembly on the earliest. And I believe presently, there may be really a backlog. However the important thing choices, I simply talked to which of them these are, can be introduced usually on the Friday. However once more, it actually will depend on — if there’s a vacation, I believe, this week, you may have a — it is the first of Might, which is a vacation in some nations and so forth. So I do not know particularly when.

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Zoe Karamanoli, RBC Capital Markets, Analysis Division – Analyst [27]

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Okay. That is very helpful. After which I’ve few extra questions. So going again to the COVID-19 influence, has this influence your launch preparations on the subject of your technique and which nations you’ll goal and method first?

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

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No, not likely. So we’re clearly going middle by middle. Now we have recognized the facilities which might be most definitely to grow to be early adopters. And people had been, given their competencies and assets and expertise. They’re most definitely to have or generate optimistic experiences early on. And that — we, in fact, pair with an underlying matrix of early-launch nations versus later-launch nations from a pricing and reimbursement perspective. And it is too early to say actually at this time limit whether or not there’s going to be a specific delay in anybody nation.

So we have simply stated that if we have a look at how the COVID-19 pandemic may doubtlessly influence our enterprise, clearly, there is likely to be some influence as to the timing of pricing and reimbursement choices. However we won’t say at this time limit, particularly how or even when it would have any influence in any respect.

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Zoe Karamanoli, RBC Capital Markets, Analysis Division – Analyst [29]

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

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

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Sure, we won’t apply for breakthrough remedy designation primarily at any time limit, and it is actually one thing we’re contemplating. We do have quick observe designation, and that provides us numerous the issues that you simply actually need, primarily, together with ongoing submission of software knowledge and so forth. What breakthrough remedy designation provides you is formal involvement of senior FDA personnel, which is, to a sure extent, one thing we have already got. However we’re contemplating it, whether or not it’d make sense or not and we are able to submit that software at any time limit.

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Operator [31]

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Our subsequent query comes from the road of [David Hedden] of Rx Securities.

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Unidentified Analyst, [32]

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Simply going again to the CHMP course of. Along with your responses to day 180 questions, are you able to simply give us a taste for the content material of the day 180 questions. Was there something just like the day-120 that maybe they felt wasn’t fairly addressed? After which after the day 120 questions, you stated that you simply had been happy with the responses. Once more, how assured are you in response to the day 180?

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

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Nicely, I am not going to enter the entire particulars across the questions and the responses that we supplied. As I stated, the dialogue broadly is round identification of the best sufferers, i.e., these sufferers with the very best diploma of unmet medical want who would profit probably the most from this remedy in addition to the design of the publish approval research. And as you possibly can think about, you may have a dialogue with the rapporteurs and then you definately contain a broader group of individuals and so forth. And based mostly on that, you then provide you with this remaining record. And that accommodates broadly talking, questions that we’re snug addressing. And as I stated, we’re already within the technique of addressing these questions in order that the CHMP might transfer forward throughout the timeline that we have now indicated.

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Unidentified Analyst, [34]

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Okay. Nice. After which simply on the anti-GBM research, with the outcomes — preliminary outcomes developing. I am simply questioning how we are able to discover success of that research and what you’ll count on usually within the affected person inhabitants handled with commonplace of care? What quantity of sufferers do you need to see dialysis free?

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

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Nicely, at the moment, primarily, 2 out of each Three sufferers find yourself in dialysis. Now whether or not they try this or not, will depend on various various factors, together with after they’re recognized and, in fact, the impact of remedy and so forth. I am not ready and we’ve not outlined a form of clear minimize quantity that might point out that this can be a profitable have a look at the totality of knowledge, totality of outcomes, along with the investigators, and decide what this means and what could be the subsequent steps for this potential indication.

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Operator [36]

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(Operator Directions) The following query comes from the road of Arvid Necander of Redeye.

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Arvid Necander, Redeye AB, Analysis Division – Analyst [37]

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And so taking a look at COVID from a little bit of a special angle, I assume, there’s been an increasing number of proof introduced displaying a hyperlink between COVID-19 and GBS. The article in New England Journal of Medication, obtained fairly a little bit of traction, I assume. How do you view these studies? And is that this a chance that you simply’re planning on addressing?

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

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Sure, you are appropriate. There was a report not too long ago featured in New England Journal of Medication, a report from Northern Italy on the variety of affected person instances the place clearly there’s a suspected hyperlink between the SARS-CoV-2 virus and subsequent type of GBS and that has really additionally beforehand been reported in The Lancet based mostly on some affected person knowledge in China. And it’s totally potential that there’s a hyperlink between SARS-CoV-2 and GBS. As you already know, GBS is triggered by an infection, and various viruses have been related to it, together with some with corona background. So it is actually very potential. And now what does that imply? Given the contagiousness of this explicit virus, clearly, if there may be such a connection, you’ll count on fairly various individuals to be doubtlessly uncovered, if you’ll, to the virus and doubtlessly, you would possibly see some spillover to GBS. However at this time limit, it is simply too early to invest. However clearly, it is one thing we’re taking a look at and we’re additionally contemplating the right way to talk about this with the regulatory authorities.

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Arvid Necander, Redeye AB, Analysis Division – Analyst [39]

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Okay. Sure. After which my second query is regarding the regulatory path in Europe. So contemplating you are in discussions with EMA and likewise assuming a conditional approval, are you able to say something about your expectations for the trial design within the following — within the post-approval research that can observe that? Do you count on it to have the identical — do you count on the affected person recruitment to be about the identical as within the U.S. pivotal trial? Is it potential that it may very well be a randomized trial as nicely? And sure, what are your expectations?

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

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I would wish to say, I imply, as I simply indicated, that is really being mentioned now. It is a part of our dialogue, it is likely one of the questions or various questions that we’re addressing. And so I believe we should always simply wait and see as soon as the CHMP weighs in, then we’ll have primarily the consequence. There may be various totally different trial designs that may very well be carried out. And I believe at this time limit, we should always simply wait and see what would be the remaining resolution.

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Operator [41]

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Okay. There appears to be no additional questions on the road presently, so I hand again to our audio system for the closing feedback.

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

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Nicely, thanks very a lot, everybody, to your curiosity and time at the moment. Now we have a really thrilling interval forward of us, and I look very a lot ahead to conserving you knowledgeable. So with this, thanks a lot. Bye-bye.