Edited Transcript of HMED.ST earnings conference call or presentation 16-Jul-20 12:00pm GMT

Whereas we now have, total, been capable of preserve a excessive stage of productiveness regardless of the impression from the COVID-19 pandemic, affected person recruitment into the continuing AMR and GBS Section II research has been delayed, as the choice was taken to briefly droop recruitment and no sufferers had been thus enrolled through the second quarter. As communicated earlier, the impression from the pandemic is due to this fact anticipated to increase recruitment time traces by Three to six months. At the moment, we count on to reinitiate enrollment in each research through the third quarter. Within the anti-GBM Section II examine, we accomplished enrollment within the investigator sponsored program again in January this 12 months, and we count on the primary information readout within the third quarter, as indicated earlier.

Lastly, I additionally need to spotlight how we proceed to construct a high-performance group, whereas including each capability and new competencies. In June, we introduced the recruitment of Professor Achim Kaufhold, as Chief Medical Officer. Professor Kaufhold brings in depth expertise as a senior chief in immunology, infectious ailments and oncology and can assist the corporate’s growth outdoors transplantation. This morning, we additionally introduced the appointment of Katja Margell, as our new Head of Company Communications. Katja brings in depth expertise from strategic, company and capital markets communication for main communications businesses and corporations and will likely be an ideal addition to the Hansa workforce. Katja will assume her new position efficient instantly.

Now please flip to Slide 4. As I stated earlier, we’re very excited to have obtained a optimistic opinion from the CHMP. This brings hope to 1000’s of extremely sensitized sufferers throughout Europe, ready for a life-saving kidney transplant and takes Hansa Biopharma one necessary step nearer to changing into a commercial-stage biopharmaceutical firm. The choice by the CHMP additional served to validate the potential of Hansa Biopharma’s proprietary drug growth engine to develop approvable immunomodulatory drug candidates for uncommon and severe ailments and comes at a time after we are considerably increasing our actions into autoimmune ailments, gene remedy and oncology.

Extra particularly, CHMP recommends conditional approval of imlifidase for the desensitization therapy of extremely sensitized, grownup kidney transplant sufferers with a optimistic cross-match in opposition to an accessible illness donor. The optimistic opinion from the CHMP comes on the again of a 16-month repeat course of by EMA, and the advice is predicated on information from Four accomplished Section II research with imlifidase and kidney transplantation throughout Sweden, France and the U.S. All through the assessment course of, imlifidase was supported by EMA’s Precedence Medicines Scheme, which supplies early and enhanced scientific and regulatory assist to medicines which have a specific potential to handle sufferers’ unmet medical wants. Adoption of the optimistic opinion by the European Fee is predicted within the third quarter of 2020. As communicated earlier, our instant purpose stays to launch imlifidase within the first clinics within the fourth quarter of this 12 months.

Our launch technique will likely be centered on main kidney transplantation facilities with the potential to turn out to be early adopters and facilities of reference. A post-approval examine will run in parallel with the launch and will likely be an extra method for key clinics to get expertise with imlifidase.

Please flip to Slide 5. Within the U.S., we submitted the proposed examine protocol for the randomized managed examine with imlifidase in kidney transplant to the FDA on June 17. We intention to begin recruitment in This fall 2020, following receipt of the required approvals and the initiation of trial facilities within the U.S. Nevertheless, we acknowledge the chance of a possible timeline impression as a result of COVID-19 pandemic, which is affecting precedence setting by the FDA in clinics. The proposed new trial would come with 45 sufferers with a cPRA rating of 99.9% or above at 10 to 15 facilities within the U.S. eGFR, which is a measure for kidney perform, will likely be used as a circuit endpoint after 12 months to display a medical advantage of imlifidase remedy versus sufferers being waitlisted.

The outcomes from this new medical examine may assist a BLA submitting within the U.S. by 2023 underneath the accelerated approval pathway as communicated earlier. Clearly, we’ll do what we will to compress the method and timeline as a lot as attainable.

Please flip to Slide 6. If we glance past transplantation, affected person recruitment into the continuing AMR and GBS Section II research has been negatively impacted by the COVID-19 pandemic, attributable to a brief suspension of affected person recruitment. No sufferers had been concerned through the second quarter. Finish of the second quarter, Four of the focused 30 sufferers have been enrolled in every of the respective research. As communicated earlier, the impression from the pandemic is predicted to delay recruitment timelines for these research by Three to six months. We count on to reinitiate enrollment in each research within the third quarter this 12 months, and enrollment within the AMR and GBS research is now anticipated to be accomplished within the first and second half of 2021, respectively. Within the anti-GBM Section II examine, we accomplished enrollment within the investigator sponsored program, again in January this 12 months, and we count on the primary information readout within the third quarter, as acknowledged beforehand.

Please flip to Slide 7 and a abstract overview of our pipeline. As depicted on this overview slide, because of the continued progress over the previous years, we now have now developed a broad medical pipeline in each transplantation and autoimmune ailments, and we now have thrilling preclinical initiatives ongoing in most cancers and antidrug antibodies, augmented shortly by the initiation of preclinical actions in gene remedy by our accomplice Sarepta.

I’ll now hand over the decision to Donato, who will take us by means of the just lately introduced unique partnership settlement with Sarepta Therapeutics in gene remedy in addition to the financials. Donato, please?

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

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Thanks, Sam. Please flip to Slide 8. As highlighted by Soren, the Sarepta settlement was the primary partnership in gene remedy for Hansa Biopharma and serves as a landmark milestone for the corporate, as we increase our enzyme know-how past transplantation and autoimmune ailments. It is a distinctive alternative for each corporations to mix efforts and use Hansa’s antibody-cleaving enzyme, imlifidase, to doubtlessly allow it to entry to gene remedy for a wider vary of sufferers, whereas unlocking vital extra potential worth. It’s estimated that 15% to 20% of sufferers in every of the two related indications have preexisting neutralizing antibodies to AAV-based gene remedy, which prevents the sufferers from being handled.

Underneath the settlement, Hansa grants Sarepta an unique license to develop and promote imlifidase as a possible pretreatment previous to the administration of gene remedy in sufferers with neutralizing antibodies to AAV vectors in Duchenne muscular dystrophy and limb-girdle muscular dystrophy. Sarepta will likely be answerable for conducting and financing all preclinical and medical research to develop imlifidase as a pretreatment to Sarepta’s gene therapies in addition to any potential subsequent regulatory approvals. Hansa will assist the event program with know-how, current information and regulatory belongings, in addition to by supplying imlifidase for growth functions freed from cost.

The numerous potential worth of the partnership can also be mirrored within the economics. Underneath the phrases of the license, Hansa obtained USD 10 million upfront and will likely be eligible for as much as USD 397.5 million in funds upon achievement of sure predefined growth, regulatory and gross sales milestones, with gross sales milestones accounting for almost all of such potential funds. As well as, Hansa will ebook all gross sales of imlifidase and earn excessive single-digit to mid-teens royalties on Sarepta’s incremental gene remedy gross sales and treating Nabs-positive sufferers, enabled by means of pretreatment with imlifidase.

Please flip to Slide 9. With the persevering with developments we now have made throughout our operations, we now have additionally seen investments growing through the first half of this 12 months with regard to our pipeline in addition to associated to the business preparations, as we’re on the point of launch. For the primary half of 2020, our SG&A bills amounted to SEK 88 million, in comparison with SEK 68 million in the identical interval 2019.

Our investments in R&D amounted to SEK 106 million for the primary half of 2020, which is up SEK 18 million in comparison with the primary half of 2019. Investing in R&D and our medical affairs actions stay a continuing precedence for short-, mid- and long-term worth creation. The web loss for the primary half of 2020 amounted to SEK 193 million, in comparison with SEK 155 million for a similar interval 2019.

Please flip to Slide 10. Money move from working actions amounted to minus SEK 199 million for the primary half, in comparison with minus SEK 180 million for a similar interval a 12 months in the past. On the finish of June, our money place, together with short-term investments, amounted to SEK 400 million, which is equal to roughly USD 40 million. Starting of July, we considerably strengthened our money place by profitable completion of SEK 1.1 billion direct placement of 4.Four million newly issued shares. The position was oversubscribed a number of occasions and included vital participation from main life science traders within the U.S. and Europe. The web proceeds of the inserting will likely be used to proceed to develop and increase Hansa’s R&D pipeline in addition to to fund potential launch and commercialization of imlifidase in kidney transplantation. Extra particularly, the proceeds will allow us to fund the continued growth of imlifidase for added indications similar to AMR, GBS and anti-GBM in addition to our ongoing business buildup in preparation for the anticipated upcoming launch in Europe. And we plan to speculate additional within the firm’s growth of next-generation IgG-eliminating enzymes for repeat dosing in addition to fund working capital wants and basic functions. With the numerous capital injection, we count on our operations to be financed into 2023.

With this, I hand again to Soren to offer his last remarks.

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

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Thanks, Donato. Now please flip to Slide 11. Over the previous 12 months, we have made vital progress throughout our enterprise and pipeline growth operations. Our group has additionally expanded as we proceed to strengthen our R&D workforce and put together for the launch of imlifidase in Europe, anticipated later this 12 months. We’re looking forward to additional worth creation with many necessary milestones in 2020 and the years to come back. Following the optimistic opinion finish of June, we count on formal adoption by the European Fee and conditional approval within the third quarter. Assuming the approval is obtained, as anticipated, we intention to launch imlifidase within the first clinics within the fourth quarter. Within the third quarter this 12 months, we also needs to have the primary information readout from the finished anti-GBM examine. The readout from this Section II trial would be the first high-level set of full information from a Section II examine outdoors transplantation and can mark Hansa’s continued development into new indications and therapeutic areas past transplantation. Within the U.S., our imlifidase kidney transplant trial is predicted to be initiated in This fall this 12 months, following the required protocol and moral approvals. As highlighted earlier, the brand new examine would enroll 45 extremely sensitized sufferers at 10 to 15 facilities within the U.S.

In abstract, 2020 has already been very eventful and can proceed to be an thrilling 12 months for Hansa Biopharma. We stay up for protecting you up to date on the progress of our journey as we rework the corporate into a completely built-in, commercial-stage biopharmaceutical firm that brings life-saving and life-altering therapies to sufferers with uncommon ailments and generate long-term worth to our shareholders and society at giant.

Please flip to Slide 11. Earlier than we enter the Q&A session, I wished to deliver to your consideration that we intend to prepare a Capital Markets Day later this fall. Additional particulars on the format and content material will comply with shortly, however already now, we’d encourage institutional traders, analysts and media to save lots of the date for the occasion, which is predicted to happen October 29, 2020. With this, we’re now 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 Zoe Karamanoli from RBC.

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Zoe Karamanoli, RBC Capital Markets, Analysis Division – Analyst [2]

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Two questions from me, please. The primary one, given the latest take care of Sarepta, I’m wondering in case you may give us somewhat bit extra concerning the discussions with different gene remedy gamers, and any shade you’ve gotten almost about the variety of corporations you’re in dialogue in the meanwhile, if this quantity has elevated put up the announcement of the deal? And any indication as to how superior are these discussions and whether or not we ought to be considering one other potential deal because the near- or longer-term occasion?

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

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Effectively, thanks, Zoe, for that query. So clearly, we’re in discussions with various main gamers within the discipline. Clearly, the problem that Sarepta is encountering and seeing is one which different corporations is coping with as effectively. And so we now have had these discussions ongoing for some time. They proceed. At what level they are going to result in the following deal to be introduced, I simply can’t predict. There may be clearly quite a lot of curiosity and so we’re persevering with the discussions. I am unable to offer you any particular quantity as to what number of we’re speaking to. However clearly, there’s various corporations on the market which have vital challenges with neutralizing antibodies. In order you’ll be able to think about, it is actually an inexpensive quantity. So I suppose that was the query or did I reply it conceptually.

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Zoe Karamanoli, RBC Capital Markets, Analysis Division – Analyst [4]

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Sure. That is positive. I perceive if you cannot give extra particulars. After which the second query, from a medical growth perspective and following the latest capital increase, what are your priorities for creating imlifidase in different indications? Is the present indication the principle focus? Or we should always count on to listen to extra in extra indication? And any shade you may give on the timing of this?

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

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So we’re very privileged to have a platform that, to this point, has generated very, superb leads to various totally different areas, and we’re pushing forward as quick as we will now with extra capital readily available to develop imlifidase for a spread of indications. Clearly, inside the transplant area, kidney will not be the one organ, the place you’d need to allow a transplant. So we’re taking a look at different organs there. However importantly, we’re wanting on the autoimmune illness area as a really thrilling and promising area to additional develop imlifidase. As you understand, we now have 2 ongoing trials there, anti-GBM and Guillain-Barre syndrome, however there are actually different ailments, the place you’ve gotten very sturdy upfront acute assaults, the place coping with that assault will likely be critically necessary. So we’re taking a look at what may be finished there with imlifidase, clearly, in gene remedy area that we’re taking a look at, as we simply mentioned. After which we now have preclinical actions within the oncology area. Now imlifidase will not be the one molecule in growth. We’ve the next-generation of enzymes additionally in preclinical growth, the place we try to develop them for repeat dosing. And that clearly, if profitable, would open up a universe of ailments the place repeat dosing is extremely related.

Within the autoimmune illness area, there’s various very severe ailments, persistent autoimmune ailments, the place you’ve gotten pretty speedy illness development, after which you’ve gotten flares and the place you’d need to take care of these flares in a short time. And so if we may efficiently develop a molecule that would do this to take care of these gamers then that can deliver quite a lot of worth, I believe, to the sufferers. In order that’s actually an space that we’re taking a look at as effectively. As you understand, we now have our lead candidates presently preparing for IND-enabling tox research, and we’re hoping that we will take it into the clinic within the foreseeable future.

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Operator [6]

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And the following query comes from the road of Ingrid Gafanhao from Kempen.

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Ingrid Gafanhão, Kempen & Co. N.V., Analysis Division – Analysis Analyst [7]

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In order you talked about, you simply obtained the CHMP optimistic opinion for Idefirix in kidney transplantation in Europe. And we all know that that is going by means of a conditional approval course of. So have you ever gotten already any perception from the EMA on how the confirmatory trial ought to appear like? Or is that one thing that you simply count on to get when the formal approval comes alongside?

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Søren Tulstrup, Hansa Biopharma AB (publ) – President & CEO [8]

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So it actually has been a part of the dialogue with the CHMP, what would be the design of a put up approval examine. So that’s a part of the choice that CHMP has made, and that can then be formally endorsed by — hopefully by the fee comparatively quickly. And so what we total are saying is that this will likely be a examine that’s designed to supply extra of the identical, proper? So it is going to be a examine the place we’ll take a look at the efficacy of Idefirix to allow kidney transplants in extremely sensitized sufferers. And the particular design, we’ll get again to the weather at a later stage. However this clearly will likely be an necessary half additionally of the general launch efforts as a result of it is a wonderful method to truly generate expertise in related facilities in Europe.

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Operator [9]

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(Operator Directions) Our subsequent query comes from the road of Maneka Mirchandaney from Evercore.

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Maneka Mirchandaney, Evercore ISI Institutional Equities, Analysis Division – Analyst [10]

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I simply had a pair on the anti-GBM outcomes arising. Are you able to discuss a bit concerning the anticipated pure historical past for these sufferers over 6 months? And what you are hoping to see on the first endpoint? Is it the stopping of development of sufferers to dialysis? Or do you suppose there is a potential to see some reversion on want for dialysis as effectively? After which given the rarity of the illness, what have been your conversations with regulatory businesses on the trail ahead to registration after the information as effectively?

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

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Thanks, Maneka, for these questions. So in case you take a look at pure historical past, what sometimes occurs to those sufferers is that 2 out of three, roughly, will find yourself shedding kidney perform altogether and occurs very, in a short time following the assault. So what we’re in search of actually on this examine is peer alerts that you may produce a greater end result in case you deal with with imlifidase in these sufferers. Probably, you would additionally see a reversal, a slight reversal in these sufferers ending up in dialysis. However the important thing parameter actually is can we forestall sufferers shedding the kidney perform and ending up in dialysis. So that’s what we’re taking a look at. And you then’re proper, I imply, that is actually an ultra-rare illness affecting roughly one in one million. So it’s important to suppose lengthy and onerous about the way to design a subsequent examine. We’ve not had in depth dialogue with the regulatory authorities but on this. Clearly, we have had some when designing the continuing examine. However as soon as we now have the readout from that examine, we’ll interact extra broadly with regulatory authorities to debate the trail ahead.

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Operator [12]

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We’ve a follow-up query from the road of Zoe Karamanoli.

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Zoe Karamanoli, RBC Capital Markets, Analysis Division – Analyst [13]

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Only one extra query relating to the trial recruitment. I do know you talked about that there was a delay attributable to COVID for the GBS and AMR trial. I am questioning given the uncertainty additionally sooner or later about how COVID disaster will evolve, is there you’ve gotten otherwise you’re planning to have any mitigation technique almost about how we will enhance trial recruitment price?

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Søren Tulstrup, Hansa Biopharma AB (publ) – President & CEO [14]

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Thanks, Zoe, for that follow-up query. Sure, we do count on a delay as a result of, as I stated, we now have carried out a brief suspension of recruitment to protect information integrity and in addition for logistical causes. However we do count on to have the ability to reinitiate affected person enrollment now. Primarily, we now have remained in ongoing contact with the trial facilities, and so we ought to be able to reinitiate very shortly. Clearly, we missed some alternatives, and also you do must form of get this again high of thoughts in facilities. However when you’re there, we’re hopeful that, because of the catch-up impact, we’ll see a speedy uptake in some unspecified time in the future, and we should always then be capable to, once more, full enrollment with a delay of most Three to six months, doubtlessly much less. Probably, we’ll be capable to catch up, however I am unable to predict that at this level.

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Zoe Karamanoli, RBC Capital Markets, Analysis Division – Analyst [15]

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You are planning to provoke on extra websites as effectively, proper?

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

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We’re actually taking a look at that, sure. That is one mitigation technique, sure.

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Operator [17]

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We’ve 1 extra query from the road of Viktor Sundberg from ABG.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Analysis Division – Analysis Analyst [18]

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So on gene remedy, there’s quite a lot of applied sciences on the market making an attempt to sort out the difficulty with antibodies. Are you able to maybe give us some extra taste of the benefit of imlifidase in decreasing antibodies in comparison with different applied sciences on the market similar to, I do not know, lipid (inaudible) engineered caplets, immunomodulatory medicine together with gene remedy and so forth? And would you say that you are the most superior know-how for tackling this downside, on condition that you have already got medical information out of your transplant trial?

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Søren Tulstrup, Hansa Biopharma AB (publ) – President & CEO [19]

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So I am not going to touch upon every of the totally different approaches. There’s fairly a broad vary of various approaches taken, together with some new ones in each. However I might say, total, what is kind of distinctive and noteworthy about imlifidase is the truth that you’ve gotten this very speedy and whole impact, proper? Inside a few hours from a 15-minute infusion primarily simply knock down IgG, which is a essential part and the principle form of driver of the neutralizing antibody downside. And so that’s fairly distinctive. I am actually not conscious of something in competing pipelines or current form of approaches additionally in plasma alternate and so forth, what has been tried by the businesses. That has — that may produce an analogous outcome, proper? So we actually suppose that it is a doubtlessly very, very proactive strategy to take, and we’re very inspired by the preclinical information that has been produced to this point, together with information in nonhuman primates displaying not simply that neutralizing antibodies may be taken out of the equation, if you’ll, but in addition that this results in elevated gene expression.

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Viktor Sundberg, ABG Sundal Collier Holding ASA, Analysis Division – Analysis Analyst [20]

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Okay. And a follow-up. So will your gene — or will your — or will imlifidase be utilized in Sarepta’s pivotal trials? Or will this be investigated in a separate trial with Sarepta after which utilized in mixture with the product as soon as it is launched?

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Søren Tulstrup, Hansa Biopharma AB (publ) – President & CEO [21]

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How particularly it is going to be carried out by Sarepta, I imply, we’re taking a look at this at this time limit. However clearly, they’ve trials ongoing they usually have carried out the trial exercise they usually’ve encountered these points. So there’s a pretty, form of, easy method to proceed from that foundation. However how particularly that will likely be finished, we’re discussing. We’ll must see.

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Operator [22]

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As there are not any additional questions, I will hand it again to you, Sam.

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Søren Tulstrup, Hansa Biopharma AB (publ) – President & CEO [23]

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Okay. Effectively, thanks a lot, operator. And thanks, everybody, in your curiosity in the present day. As I stated, this has been a really thrilling first half of 2020, and we stay up for continued progress within the second half and in addition protecting you up to date. So keep tuned, and I hope to see fairly a lot of you at our Capital Markets Day, in October. All one of the best. Bye-bye.