Q3 2020 MorphoSys AG Earnings Call
Please note.
But for a duration of the presentation or participants will be listed on the mode and a conference is being recorded after presentation. That was an opportunity to ask questions. Please note that we should only take your questions. If you have registered by name should anyone need assistance during the conference call they may speak to the pressing star and zero on the telephone now, I would like to turn the conference over. We are not go ahead ladies and gentlemen. Good morning. Good afternoon. Good morning. My name is Yolanda Guevara direct investor relations of my fuses and it's my pleasure to welcome you to our third or the 2020 Financial results and operational update conference call.
Joining me on the call today are shown plug 50000 miles of research and development officer. And Chief Operating Officer wage release was issued yesterday without a third quarter 2020 Financial results and business update. This can be found on our website along with the presentation for today's webcast.
Well, we begin I'd like to remind even slide to that some of the statements made during the call today are forward-looking statements including statements regarding our expectations for the commercialization of our products and our development plans off the impact of COVID-19 on our business and expectations for the compound pipeline as well as the development plans of our collaboration Partners. These forward-looking statements are subject to a number of risks and uncertainties says my make also actual results to differ materially including those described in before this twenty F and and report all for the year ended December Thirty One twenty nineteen thousand from time to time in other SEC documents of Moses. It is important to keep in mind that our statements on this webcast big as of today.
Once like three you find the agenda for today's call. So I'm probably begin with an overview of corporate highlights from the third quarter followed by rule and who will provide a commercial update then multiple R&D activities before training the quality ends for summary or third quarter and nine months and after results following these prepared remarks. We will open the call for your questions wage. I know handle the call over to Sean Paul.
Thank you, Julia. Good day everyone and thank you for joining us to discuss the considerable progress. We have made over the past months as we transition to commercial company with sizable clinical development Pipeline and multiple Partnerships worldwide.
In the third quarter of 2020 we achieved great progress in all operational areas.
Ranging from commercial to clinical development to research the approval of Mondovi marked transformation into a fully integrated biopharma company page to master every step of the value chain.
I am also very excited about two deals that will enhance our clinical development and our research capabilities.
Agreement with with them car ads to our backbone strategy while the in licensing of an Innovative technology from Cherry biolabs compliments our research portfolio.
moving to slide six
third quarter of 2020 was highlighted by the FDA accelerated approval of Manju V as a treatment for non transplant eligible relapsed of factory diffuse large b-cell lymphoma or dlbcl which represents the fda's first approval for second-line treatment in this indication off.
In Sapulpa, I will teams have been laser-focused to bring mongeau V2 patients suffering with this deadly cancer who have limited treatment options.
We are very pleased by mongeau earliest from momentum and initial uptake despite the challenge we faced with a marketing solution during the COVID-19 pandemic.
Our lunch is fully on track and has generated revenue of 5 million dollars or four point four million euro in the first seven weeks of lunch break during our cable event in September. We provided an initial guidance front estimating the peak potential of Monroeville in relapsed of faith in the US to be between $500 and $750 US dollars.
Even the patient population and the duration of therapy.
Hold on, we'll provide more color on the lunch and the accelerated momentum we have seen since module is approval We Believe mongiovi has the potential to come back from the standard of care in dlbcl given its approved indication can be nobility and accessibility.
Lately, our aim is to improve cure rates in first-line Deal vcl knowing that each year. Approximately 30,000 patients are diagnosed with in the us alone.
This is just the beginning for taffeta as a backbone in dlbcl. And we believe it offers significant opportunities as a planning a product and for growth into additional indications.
Speaking to other recent news yesterday. We announced that we sign an agreement with them car to develop deficit in combination with Claim by specific cd23 antibody play Moto map.
executive on our back
Phone strategy disagreements ship box our ongoing efforts to expand the use of taffeta map into new treatment lines and indications including Frontline dlbcl as well as her lymphoma.
I will aim is to establish the file system as the combination partner of choice in Hematology Oncology and we have further interest from other companies want to combine deficit with their assets.
Moving now to slide seven on the progress. We have made with our broader pipeline.
We continue to advance the development of sales. Our cities of antibody in an auto even indication called autoimmune. Membranous nephropathy.
Patience with this diagnosis of the high unmet medical need could develop end-stage renal disease and ultimately require dialysis or kidney transplant.
With an auntie series of antibody we specifically Target plasma cells the source of the alternative of these and therefore potentially provides the target to the treatment for patients.
Multiple will provide additional details on this program later in the call.
Moving now to trim fire which continues to provide an increasing royalty stream.
Tremfya was approved for the treatment of adult patients with active psoriatic arthritis in the US and Canada earlier this year and in October, Johnson announced the positive opinion from the chmp recommending the expanded use of tremfya for the treatment of adult patients with active psoriatic arthritis in the European Union.
We are very encouraged by Johnson's commitment to broadly develop tremfya Beyond rheumatoid arthritis, or are a into other indications off just recently presented interim data from the Galaxy one study which showed encouraging results in patients with crohn's disease.
Tell me now to GSK has resumed the enrollment of patients into the contrast program after it had also been paused due to the fact in nineteen pandemic.
As a reminder contrast is a phase 3 Program evaluating in patients with moderate-to-severe RA in three people.
GSK is also conducting clinical trials building on our research strengths and adding a new Innovative technology to our portfolio.
Yesterday as well. We announced licensing agreement with cherry biolabs, which gives us access to the technology for the development of the Next Generation T-cell engage or molecules.
building Upon Our psychic platform
We are excited to build one of our new next success stories on the basis of this pioneering technology.
The game will provide more details later in the call.
Riemann with cherry by elapsed since all Innovative technology portfolio and our new collaboration with Van car and just cause our confidence in life back bone for new combinations and the potential new standard of caring dlbcl.
With these advances in multiple come we are at the beginning of a new phase investing in new technologies adding to our portfolio and establishing stuff as long as the combination partner of choice.
And finally, we reported strong financial results in the third quarter with group Revenue increasing 76% to 22 million-euro. This solid performance was the results of growing revenues primarily from property development and supported by the revenues from the initial seven weeks of the module long with royalty income from our past programs such as as trim fire importantly. We have a strong balance sheet from which to invest into the broad development of deficit in our Diversified pipeline in order to enhance all the shareholder value.
With that I will now turn the call over to hold on for a commercial update on mongiovi. Hold on, please.
Thank you, Sean Paul. And hello everyone. It's good to be speaking with you today. This is the first time we're sharing module earnings with you and I'll be talking about the strong momentum with building a market with our remote will be launched together with our partner inside. We have delivered on a rapid speed to Market. Our teams have been laser-focused with a singular mission to bring my jewelry to patients and we are pleased with what we are seeing.
Moving to page nine to take a look at the indication maju V in combination with lenalidomide was approved for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma. Not otherwise specified including dlbcl arising from low-grade lymphoma and who are not eligible for autologous stem cell transplant.
Speaking to efficacy module produces a meaningful and durable response to treatment FDA approval was based on data from our ailments study took best overall response rate of 55% complete response rate of 37% and the median duration of response of 21.7 months note. This duration of response is based on the November 2018 data and as multiple highlight in his part this duration of response is further extended with our longer-term data off.
as we have to share
Before with you AR Rahman to be labeled translates into a set of important takeaways in our conversations with Physicians mongiovi is the first and only second line therapy resulting in a high number of complete and durable responses across subgroups.
To combine safety and tolerability profile supports a paradigm shift towards treating patients to progression potentially allowing for long-term Disease Control and Juliet with the patients in both Community Care and academic settings as an off-the-shelf product administered by a standard IV infusion that is easy to administer and does not require hospitalization or heavy monitoring.
We are hearing consistently from Physicians that module is accessibility is a strong Advantage, especially in Community Care settings.
Moving to slide number ten as Sean Paul shared net sales were five million dollars and fully in line with our launch expectations. As you know module. We received a call that FDA approval on July 31st, and the first patient was infused on August 13th, the 5 million dollars in net sales reflect orders from 140 sides of money from that time through the end of September confirming the early momentum in the marketplace as you look at the sales figure, please keep in mind that our treatment approach is different from other treatments in a space patients who are being infused with module V will be treated through progression compared to all the deal TCL treatments that are front-loaded.
RL my data indicates how many of the patients starting Friedman in Q3 will be able to potentially continue to benefit from into the coming quarters and years.
Moving to slide eleven and looking Beyond September. We have seen momentum and account up take further accelerate in October by the end of October and 250 sites of care have ordered and eighty percent of these accounts have already reordered.
Looking at the account Dynamics in more detail. We saw strong early uptake in leading academic centers right from launch as a matter of fact more than 90% of NCC and institutions Home Improvement jewelry for use and place an order.
Momentum is now shifting more to Community Care As We Came breath and key networks with approx 65% of accounts in October coming from Community Care in line with our expectations. This speaks to the broth accessibility of module be in both academic and Community settings.
Overall as we look at our account Dynamics, we are on track and field encouraged by the early adoption and continued interest in the market.
Moving to slide number 12. We've also had Google mental on the payer and reimbursement front-page coverage has been rapid and robust our teams early efforts set us up to receive the first pair of confirmation for coverage to label within two weeks from lunch since then. We have seen Universal coverage from on chovi within both commercial and government channels off and have not heard of any cases where coverage from has been denied for clinical reasons. In fact, we expect the vast majority of life's to be covered in the first year of launch.
looking at Key prescriber
Accounts which include larger Health Systems and community and quality groups. We've made significant progress achieving nearly 90% formulary approval so far in our top 30 accounts. They suck lights the hi. I'm at need and what's aided by the early inclusion of my jewelry in the nccn guidelines?
Also More than 70% of EMR order sets were added in top 30 accounts supporting pull through to enable broader of take across Networks.
In addition to pay an account coverage. We understand how important is to help remove barriers to Patient Care at Moss's. We are committed to supporting appropriate patients throughout the the access and treatment Journeys and together with our colleagues at inside. We launched the robust patient support program called my mission support.
This program offers numerous services and resources to additional patients who are prescribed and their caregivers.
During these unprecedented Kobe times. We know patients may need extra support for this reason our my mission support patient support program has launched a new initiative that supplies protective equipment of module patients in need and provides them with helpful resources to receive the treatments without interruption during the pandemic. This program is one small part of our commitment to patients are always at the center of what we do since launch. We've had close to two hundred patients and caregivers reach out to us to benefit from the valuable support resources off my mission support.
Moving to slide 13 because of COVID-19. We all Now operate in a different reality and during these unprecedented times the inspection Forces teams continue to successfully adapt and overcome, Turtles using digital Technologies to meet Healthcare professionals where they are and drive individual and peer-to-peer engagement.
Well cool with impacts the absolute number of health professional engagements. Our teams have we are extremely pleased to see the traction we have built across all channels to create strong awareness package interest from positions at levels that exceeded our expectations during the pandemic.
As we look at these last weeks, we see that our efforts to continue to engage with hcps are effective and resulting sustained leadership and share of voice with greater than 50% from module. Well ahead of other treatment options in this space. This shows the positions want to hear about my juvie and it's a testament to the team's ability to get to Physicians and get our message across
And we just like fourteen during interactions that we have with Healthcare professionals. We continue to hear that they are excited about this important new treatment option on behalf of patients specifically they are telling us that they are appreciating the overall response rate and the duration of response the value the total ability and safety profile that will truly provides the patience and the appreciate the accessibility and ease-of-use of maneuvering community and academic settings, especially during the Corvette and Eric.
We are certainly still early in the law.
Lunch and recent court Dynamics a degree of uncertainty for the winter months for all of us.
But our teams remain laser-focused to continue driving awareness of module be with Healthcare professionals, and we continue to be encouraged by the strong optic and increasing momentum. We are seeing after our first month in the market. It shows us just how strong the ultimate need from Julie is and the promise it brings the patients and with that. I'll turn the call over to Malta.
Thank you Roland in addition to the successful launch of Mondovi. We continue to expand the clinical development of table seating map.
Our ambition is to improve curates India BCL in all treatment lines and bring this medicine to as many patients as we can and as soon as we can.
It's John Paul noted Manju V is the only FDA-approved second-line treatment for patients with relapsed or refractory PCL who are not eligible for stem cell transplantation.
We believe that based on the clinical data complemented by its safety profile and accessibility Mondovi is well positioned to become a preferred treatment option for second-line patience with their beauty.
No, these are part of the MAA their European. Which was validated.
earlier this year
to come to complement this data. We initiated a new real-world data study called remind to
This study is collecting data. Not only from the patients treated with lenalidomide alone, but also from their patients being treated with other regimens.
We're also developing toughest as a first-line treatment for CLL and we have completed enrollment of our phase 1B to study one month ahead of schedule which shows the great interest of the community in this potential treatment option.
We represent initial data from this first mind study at the upcoming conference later this year.
Data from this study is the basis for our pivotal phase 3 study front mind.
There's a high unmet need for the patience in the first line setting especially for high-risk patients.
Usually diagnosed dlbcl patience with an IP. I score of 325 are considered high risk.
For these patients the chances of cure which are chop alone are less than 50%
front mind will enroll up to 900 patients and we'll evaluate the toughest then a little might combination in addition to our top compared to our Chopper loan.
We are on track to start this study early next year.
Donkey the next indication. We are exploring in a pivotal trial is relapsed or refractory follicular lymphoma.
We expect to enroll approximately 500 patients into this randomized phase 3 study and expect to initiate the study in the early part of next year.
We are confident to achieve our goal of developing cafecito as the backbone for the treatment of deer vcl across all therapeutic lines.
Our agreement with Denker is another step towards establishing toughest as the combination partner of choice for dlbcl and Beyond.
We are excited to evaluate the combination of deficit a map with then caused by specific cd23 antibody Plum Autumn up in patients where Los less refractory deal but also in patients with Frontline till BCL and relaxed or refractory follicular lymphoma.
It's John Paul mentioned earlier. We are in discussions to evaluate further opportunities for combination treatment of taffeta map. Our goal is to bring cafecito map to more hematologic cancer indications where cd19 is associated with a mode of action of the disease.
This year's bash meeting will feature several abstracts providing insights into our scientific and clinical activities to evaluate the efficacy and safety of them up in V cell lymphoma. I already mentioned the publication of initial data from our first month study in front line.
Also present additional data from the airline study that supports the remarkable durability of responses.
And for the first time we will report on cd19 expression analyzed into more biopsies of dlbcl patients before and after treatment was tougher system up.
Now moving on to our other pipeline assets where we are very pleased with the progress we have made to date in 2020.
His bottom up 3800 body previously known as more to our tool is currently being evaluated in the employ a study in patients with autoimmune. Membranous nephropathy.
we have resumed the enrollment of patients into the study after past due to the COVID-19 pandemic and are about to complete the safety running phase after completing the safety run in phase we expect that enrollment speed will significantly increase
We will share data from this study at one of the upcoming medical conferences.
Also, our partners IMAP is developing says that a map for the treatment of multiple myeloma and is currently running two pivotal trials.
It's so important upon this week. We announced the licensing agreement with cherry by Olaf.
This agreement gives more focused access to Cherry biolabs Innovative. Hemi body technology.
This technology could strongly increased specificity and selectivity of tumor targeting and enable a substantially enlarged therapeutic window off. The core of this technology is a diesel engaging molecule that is split into two complimentary fragments.
We use CD3 clinically well-established Target for the engagement of T cells.
This is combined with a concept of dual Tuma targeting one fragment of the split-season engage refused to 1 to antigens targeting antibody the birth of fragment to a different amount adjourn targeting antibody.
These two molecules called anybody's circulate freely in the bloodstream and activate T-cells only once they bind to the antigen combination expressed Council says both antigens have to have to be present on the tumor cells surface for the TCL engaged to become functional and to activate the key cell.
This licensing agreement is part of our strategy to enhance our research efforts and to focus on next-generation modalities for the treatment of cancer and autoimmune disorders.
With that I know and the call over to him for a review of our financial results thinking about it.
The third quarter was yet, another very successful quote from all sources as we posted strong Revenue growth and maintained a strong balance sheet while supporting a robust clinical development pipeline. Let's turn now to slide twenty-one.
Group revenues and the third quarter of 2020 amounted to million euros containing for the first time revenues of five million dollars or four point four million euros from the sale of module.
Revenues also include success-based payments of 10.2 million euros primarily from Jensen.
As in previous quarters the contractual royalty reporting from Genesis 4:25 has not been received yet transfer all these soft until 3:20 estimated based on the public page and change.
Final numbers can still slightly very due to the foreign exchange rate affect.
In addition to maneuver revenues the companies have been able to generate revenues from different collaborations such as inside as well as I'm a police Informer.
looking at expenses our total operating expenses in order of 2020 increased to eighty four million euros, the strong increase reflects our investments in the expense of mahfouz, if you have think the launch of Mondovi as well as the expanded clinical development for coffee table and says automatic
the expenses for research and development Rose to 34.2 million euros largely driven by expenses for external laboratory services and Personnel selling expenses increased to thirty six point nine million euros and general and administrative expenses to 15.3 million euros, both driven by higher personal expenses and expenses for external services in association with amateur we launch
Selling expenses also comprised expenses for services rendered by inside in connection with the joint activities as we report all commercial costs for the sale of majority in our Penal.
And makes before interest in Texas De mounted to -61.7 million euros as a result of the higher expenses across or categories.
Our Consolidated net loss after taxes amounted to -65.3 million year olds and third quarter of 2020 earnings per share worth -2 euros.
It's like twenty-two and presents a summary of our segment reporting for Q3 2020. As you can see in our priority development segment of forces reaches and researches and develops. Its own drug candidates focusing on cancer inflammation.
And curiously twenty-twenty the second recorded revenues of 10.5 million euros for this one point four million rows for the previous year. The increase primarily reflects product sales from juvie name is further revenues related to the inside calibration.
operating
Expenses in the proprietary development segment amount to 72.3 million euros as compared to thirty two million euros in Q3 of last year.
The elevated expenses reflect our higher Investments for the development of our proprietary programs. Hence the evil of our property development segment amounts to -61.7 million euros.
In the part that Discovery segment maphosa supplies its proprietary technology to discover new drug candidates for pharmaceutical companies and as participates in its hardness development advancements for research and development funding licensing fees, success-based Milestone payments and royalties.
Revenues in the part of Discovery II amount of 211.5 million euros and carefully twenty-twenty the ebit and our part and Discovery II Rose to an Apple 3 million euros.
Please now move to slide $23 for the key financial for the first nine months of 2020.
Food revenues through 4/4 to 291.7 million from 60.7 million euros in the first nine months of 2019. The increase was mainly driven off of operation licensing agreement with Insight in the first quarter of this year to further develop and commercialize deficit Em Up globally.
Part of the 750 million u.s. Dollar up-front payment end of the $58 premium was accounted for as revenues and 320 representing its share for the name is part of the transaction research and development expenses amount of 86.6 million euros vs. 75.3 million for the same time period of last year.
Selling expenses for the first nine months increased from 9.3 million euros in 2019 275 million euros in 20 20 in general and administrative expenses from 22.5 million to 37.2 million euros.
The even strongly increased to 101.8 million euros compared to -56.3 million euros in the first nine months of 2019.
Moving on to the balance sheet on flight 24, you see that as of September 30th 2020. We recorded total assets of approximately 1.38 billion euros versus four hundred ninety six point four million euros at the end of 2019.
Our liquidity position amounted to 987.2 million euros compared to three hundred fifty Seven point four million euros as of December 31st, 2019.
this liquidity position is reported on the balance sheet under the items cash and cash equivalents Financial assets at fair value for profit or loss and current and non-current other Financial assets that Armitage
not included on our Q3 reporting the proceeds from the convertible Bond issued shortly after the end of the third quarter as you can see on slide twenty-five.
Hello.
October 13th, 2020 we successfully placed unsubordinated unsecured convertible bonds due in 2025 and an aggregate principal amount of 325 million euros the bondage convertible into new Endor existing. No, no power ordinary Bureau shares of muscles has the convertible one will be issued at 100% of their principal amount unless previously converted redeemed or repurchase against the convertible bonds will be redeemed at the principal amount of October 16th 2025.
Because the ones who have price with a coupon 4.625 per cent per annum version price was set at 131.29 Euros representing a conversion premium 50% above the reference yet with this multiple times oversubscribed transaction. We have secured financing a very attractive conditions.
More than 130 new and existing workforces investors participated underpinning the high level of trust in and the continued appeal of a muffled.
The proceeds further strengthen our cash position which allows us to execute our ambitious growth strategy.
For the financial guidance for the full year twenty-twenty, please move to slide twenty-six.
On October 27th, we increased our financial guidance for twenty twenty and are now expecting revenues in the range of 317 to $320 billion euros, and then even in the range of + 10 + 2 + 20 million rows our guidance our R&D expenses remains unchanged in the range of 130 to 140 million euros off the updated guidance reflect higher revenues from participation in collaborations. And Trump fire royalties are expected to be at the upper end of the guidance in addition. If not also includes read news from product sales of Mondovi following it approval and subsequent launch in the u.s. In the first half of August.
This guidance is based on constant currency exchange rate and does not include any effects and potential in licensing or Career Development deals for new development candidates.
The operational and financial guidance might potentially be impacted by ongoing the ongoing Global COVID-19 crisis on muscles. This is operations, including but not limited to the company supply chain clinical trial call log as well as Timeless for Regulatory and Commercial execution ladies and gentlemen at the end of my section. Let me finish with a short personal statement.
After close to ten years with my phone, since this is my last conference call. I see if all the company before I had over to John Paul. I want to thank you all for the collaborations the trust the good dialogues we have three of those fetus has undergone a tremendous Journey since I joined when I know the part was Manju V and trample on the market and number of further development candidates and phase two and three jobs. Well as Innovative research platforms, I leave the company in very good conditions, but forces is known to have a large portfolio of proprietary important components, and it's financially stronger than ever walk along the company to grow and create further value in the years to come thanks to all of you and with this I will now turn the call over back to jump off. Thank you.
Thank you. Yes, I would like to take the opportunity to thank you for
His dedication to more for this or the last years and the great collaboration against it has been a true pleasure to work with you and I wish you all the best for your future and I'm moving to slide twenty-eight for wrap up. The third quarter was a period of significant milestones and achievements from office. We are supposed to fully making strong progress across all dimensions of our business from commercial to late-stage development to research and Innovative new collaborations.
We executed on the strong launch of mongiovi in the US fully in line with our lungs targets generated strong early momentum in the market and we continue to be encouraged by The Accelerated momentum and enhanced adoption. We are creating which will further grow mongiovi revenues and broaden our impact patients in need of new Therapies.
At the same time we continue to live in boost the current and potential future quality stream from our collaborations from the success of our partners with their respective or correct to trim file or web.
And we are on track with our goal to reach increase Financial guidance for 2020.
Ultimately, we are driven to transform the standard of care and improve cure rates in dlbcl by leveraging and unlocking cafecito Maps full potential. We have a bold Vision to establish stuff at it as a backbone therapeutic in other indication and the combination partner of choice in him oncology off.
I will think of collaboration is all first step and we will continue to share our progress with you in the months ahead. In addition. We are progressing. I mean indications and are expanding our strong R&D portfolio to create long-term success or the company and shareholder value.
With that we will now open up the line for your questions. Thank you. Okay later, ladies and gentlemen, we will now begin the question-and-answer. If you would like to ask a question, please press zero and one on your telephone keypad. Now, you will be advised when to ask your question. If you change your mind and wish to withdraw your question, please press zero six participants are requested to use only headsets while asking a question.
The first question is from Jeffery portraits of s during your line is not open.
Thank you very much for the questions and congratulations on all the progress first on the city twenty collaboration. Could you talk about whether you're free to partner with other City twenty antibodies specific since it's going to be a lot of development and secondly, do you anticipate that that in order to administer? The combination patients will have to be hospitalized and then ends are just want to congratulate you on bringing morphosis to its current very favorable position and you've guided to profitability this year. Are you confident that morphosis can maintain profitability going forward? Thanks.
Thanks for your question. I'll answer the first one multi will answer the second one and the third one. Yes. We are free to partner with any other companies having a buy specific. It was very important for us beyond the fact that we actually see a lot of value in this partnership with clean car. If we have a long-term relationship with them. This is obviously guaranteeing great Effectiveness in our collaboration for this we have promising I'll just stays data on the asset and the conventional is is very strong between mongiovi and and any City 20 City 3 which would add another layer of Effectiveness with their T. Sell engagement capability. So yes, we are free to operate with any other ones but we stop this one is actually a very very meaningful for us.
On that multiple. Can you answer the question on the hospitalization or not? Yeah. Sure. Yeah. Hi Jeff. It's so the the initial clinical study that we're certainly or car in on the hospitalization conditions come as you would normally do this interface one besetting. Remember the the two compounds have never been a combine. So in the initial stages of course patients would come to the hospitals and the phase one we conditions and then depending on the safety signal bulb we would observe you can then determine of how the continuous treatment where will occur and if this combination treatment would be appropriate to be administered in and outpatients or in a community hospital setting.
Great again, and then Jeff, first of all, thanks very much for the nice words regarding profitability indeed. You know, we we turn profitable this year. You might remember many years. He's he is back up and profitable for quite a long time actually and then decided to invest in the assets that we have in our portfolio given that we have mongiovi now in various clinical trials on going to make that compound really a big one not only relapse reflected dlbcl, but in other settings as well in another indications short-term, I would not expect despite the fact that there are increasing revenues, of course that we expect coming in that we that we will turn profitable in in the short-term frame. So we also see it as you know on Earth quite some cash with the intention to to broaden our portfolio and and therefore I think that reminds another sort of reason why you should not expect wage.
Short-term profitable profitable company right? Thank graduations again. Next question, please.
The next question is from James Garden of JPMorgan your line is not open.
Hello, this is James Corden from JPMorgan tax taking the questions one question on the on the convertible please to start with so could you just talk about your intended use of Pharmacy? And if that's your business development is later feature. What's the focus of wish list in terms of targets to become it just now also about maybe broaden the portfolio. So that's the first question. And the second question is about Q35 using the full year twenty-twenty Revenue guidance. So you upgraded for your 20 minutes by by 37 million euros in terms of revenues. How much of the of the upgrade was Manju be sales-related versus other factors between 12:30 and what all the other contribute to them and also could you help us a break him down the temperate climate in Euros of proprietary revenues you had this quarter. So the 4.4 million is going to be sales rep think you said the majority was the rest is coming from inside, but if you could clarify exactly what what are inside paying you for and how do you think this is going to evolve same Q4 and let's just finally, when do you can you tell us how many patients are dead?
The product promotion, please.
James thank you for your question. I'll handle the the first one then James will cancel the the the next one and hold on my typing for the Monroeville a question regarding the convert and aim for the convert. You know, we wanted to be in the position to have the capital and means to invest dead when first of all our internal portfolio, we you probably understand that we have a lot of opportunities ahead of us together with inside will also be on inside home and and we are actively looking at opportunities. We just executed on on to that we are announced today, but at the same time we are looking at all they're closed abilities to continue to diversify Pipeline and we thought it was the right time to to do this move to be ready to act on potential opportunities.
The guidance so James, thanks very much for the for the questions. So maybe in terms of a little bit support here as you've seen we we close at two hundred ninety-two million euros to give or take guidance is 317 to $327. So you talked about twenty-five to thirty-five million euros that we would expect Q4. If you take into account the trim fire half a certain contribution. We we booked a bit more than thirty million for the first three quarters to cure for we would expect given, you know, whether further approval to radical Fridays and so on. The number is of ten million on average is the minimum but rather a lower one, we came to the conclusion that would think that overall the translator guidance ends at the upper end of the range that we have given thirty seven to forty two million. So you have to take this number into account and deduct it from the twenty-five to thirty-five Million Dead.
So there the rest.
Is all kinds of other stuff in the first and foremost moduli contribution from the sales of the product in the US. The other parts are the usual couple of thousand miles on payments that you know from from partners that move compounds into phase one two, or three like we've seen it and now with Novartis as we announced and there are dead ft. There is FTE funding from collaborations that we have and first and foremost area. There are some Revenue contribution from the inside collaboration in that respect that contributes to a few million and similarly you have a little bit from from our other collaborations as well. So that's why and that explains more or less the three question of the ten and a half million questions because as you've seen four point four million you made the math is for the revenues from juvie, but you know, the remainder is from Milestone payments msde funding out of the collaborations.
I hope that helped and then I'll change. This is Roland regarding new patients from this of course is off that our teams are closely looking at it's also a number. However that requires triangulation at this moment in the launch given our weight-based dosing and different different timing radio station. So do we do know provide a precise number at this moment in time having said that the number of sites of care that we disclosed in the caller. I think a good reference point of a kind of interest and of the kind of magnitude that you know, we see in terms of new patients initiation.
Thanks. Next question, please. The next question is from Jason Butler of JMP Securities. The alarm is not open.
Hi, it's Roy in for Jason. Thanks for taking our questions. Just a couple of quick ones. So you you're at over 250 treatment sites at the end of October. Can you remind us the number of Target sites that you have for the US and Arthur's head of your initial expectations to achieve a given number orders at the sites and then 1:00 on uh-uh more 2024 membranous nephropathy how many pages on the US and the EU and how many progressed to ESRD? Thanks.
Thanks, Ryan. How long will take the first part of your question and probably mailed to the second part.
Yes, thank you. Sean Paul Ryan as we disclosed earlier. We are looking at about 11,000 Healthcare professionals that we have in our Target and these are this way it's over over thousands of sites of care that we have in the states. Our main focus is of course on on those top 30 top 100 top three hundred accounts where we have the highest highest number of patients and we are very pleased with the optic that we saw on the orders with received from these top accounts. We've also seen more from the periphery in the tail from smaller account to order come in as Physicians have a patient in front and and where they consider module V and great efforts just through the channels that module is available. And so I also Thursday we see that we are on a good track to actually get both the demand that we want from our most important top accounts as well as have the bottom Optimum.
in the periphery that we expected to see
yeah.
Thanks. I think we we are thinking of all we are envisaging around 10,000 patients with autoimmune membrane is primarily in the United States and all and please try me know correct me if my if my memory is incorrect, but I think this is what we what we have as an assumption for the u.s. Population.
Okay, great progress to ESRD.
Yes.
Okay, thank you, you know Ryan just two compliments on that this these patients are mostly treated by all the therapies all immunosuppressant very top off drugs some ways. We seemed ab and many actually and end up in ESRD or even you know transplant.
So there is a very high admit need.
Thank you.
Sure, next question, please. The next question is from the route. We're taking a question. Congrats on the progress. I guess. Just wanted to know if we could see skinny initial efficacy data particularly in the patients that were sort of IPI three and four in the covert that should be presenting and then secondly, just wondered if you had any or in your your partner sort of ran any preclinical studies on on the edge of the optimal combination and just wondered to what extent you you are your partners have tested the CD 2019 KO expression rational with with with your combinations. Thank you.
Thank you. Mr. Walter will handle your question. So the the data that we presented regarding first mind with a primarily focus on the safety profile of the two arms. I'm combining arch up with stuff alone as opposed to our shop with a map and then LED light bulbs and we are in the sort of final stages of evaluating the data and depending on how far we get. We may present some very high-level efficacy data off. But remember it's uh quite early in the conduct of the study and patients have not been observed long enough to give a reliable estimate on the crn pra. So we are we are looking at this right now and depending on what we can say, we will say but the main focus is really wage.
Be safety for this for this conference.
and on the on the CD 3 3 2019 rational
Oh, okay. Sorry. I didn't catch the question. Can you can you repeat please the question? Yeah, just wondered if if you were Partners have tested sort of June 19th for expression rationale with with your own sort of the combination of of mine through the inflow modem app or you sort of just you know, kind of looked at the literature. There is some law students write for for for combining those two molecules. It just wondered if you had any sort of preclinical experience yourself.
We have some experience regarding cd19 and cd20. And in fact, it actually will present some data showing a synergistic activity combining cafecito map and we took him up looking at these two Targets, but we have not of course looked at CD twenty years in combination with his 1953, but on on the on the Mystic potential of naked antecedent 9020 antibodies, we have generated some data in the laboratory and we will show some details also attached this year.
Really important. It's during the addition to the decision just a sec and a TCP pathway of Manju V plus the TCL engagement Palm City twenty-three extremely compelling. Thank you next Thursday. The next question is from Quick batch of context. The line is not open.
Okay, great. Thank you for taking my questions. Good afternoon. Good morning. And Jen's just want to thank you for your efforts and best wishes on your next Endeavors as well a couple of questions just on T 3 CD twenty so long when looking at the demographic could you maybe describe kind of um, your your initial thoughts around what you're seeing on the efficacy and safety of that agent as a as a as a stand-alone. We've we've looked at some of the data and how it Compares with the other CD three-cd twenties, you know, the efficacy seems a little bit modest and and and maybe there's some you know, CRM is the big issue for all of these compounds that you could you just give us your high-level view on how you think this asset compares to the others and in the setting of combining with my govt. Is it really more do you think the ability to differentiate will be more on the tolerability side or or really more the efficacy side and then a follow-up just around the questions on the Zen core asset, um dead.
Two questions 1 just on Mon Juve. Are there any thoughts on perhaps pursuing a subcutaneous formulation of
Of Manju V especially in the context of the gender a bad V assets, um that is going into a phase 3 trial and relapsed and refractory dlbcl. They're they're anti CD3 anti cd20 Sub-Q to just any thoughts on on some banks month.
Greg thank you. Multi will address the first one and potentially the second one.
Yeah, so we we have of course studied the existing cd23 by specific molecules into a pretty good detail wage. Um, I think they are my my personal take is that the differences in efficacy at this moment. I'll probably not very high wage. I think there are nuances between the between the various modalities. We are we are quite encouraged of what we see regarding the edge of the sink or activity also with respect to the efficacy and safety profile of the molecule. We will see a little bit more data at upcoming conferences. So I think overall we think that the single molecule is on par with you know with with the other molecules that wage
Are currently being developed with respect to your maybe once a month. But yeah, one comment on that drag, um, I mean beyond the asset itself and the comparison a potential of their assets that by the way, we could still partner with as we said earlier because we are non-exclusive agreement with with 10, It's important to remember that was not driving so fucking was them go is all long-term relationship with them. We know them. Well, they know as well. There is a trust slash Effectiveness Factor here which will make things much easier in the implementation of the development plan. I mean partnering with another company for development is always a challenge and with exam, we are in known territory. And as you know, very well money on jewelry comes from the Glencoe bench sell there is kind of a familiarity here, which is a big factor in addition to the strength of the asset.
No, no, thanks for the addition with respect to the subcutaneous development. I would say we are we are considering various option regarding a different schedules and modes of application of Mondovi going forward and at this moment. I'll be a little early to to say what we will do as a long-term strategy, but it's on our radar screen. It's part of our life cycle management strategy and we would we would probably be able to speak to this in the next coming months, but it's clear that we took thinking about life cycle management strategies for mongiovi. This includes subcutaneous formulation, but potentially also other options to facilitate wage.
administration of mongiovi
Thank you. One last question. Maybe the last question is from of birnberg Yolanda open.
Thanks very much for taking my questions and congrats on the progress. Two questions, please first is a early-stage acid more to 10. I think your partner release them quite exciting pretty clean with data as to see if I recall correctly you retain the rights in the US. Just wondering if you have any plans to to further develop that asset in a college setting and then also secondly on the one of the ash presentation you present some preclinical data combining tough and the city 47,000 wondering if that's something you are looking at giving you a partner IMAP has a city 47 anybody just want to get out there. Thanks very much.
Thank thank you for the question. I'll give a shot answer and multi will elaborate obviously very excited by 2:10 and and obviously progress. Partner here and and 4:47. It's as I mentioned earlier in calls there are we've been looking at 47 as well in addition to City twenty six threes. So this is something we have in the radar, but obviously we have to see if it makes sense in terms of capital allocation versus the by specifics. But yes, we have it in the wrong method. You want to speak about 2:10?
Yeah, very quickly. We have a good relationship and partnership with IMAP to whom our 210 molecule is licensed at the moment. We are looking at the data on a continuous basis and then the contractual situation enables us to project the assess the data and to decide whether we want to opt back in and participate in the future stages of development. So that's that's a good situation. We are we are really pleased with them how I map is pursuing this and we will we will stay tuned and update you. Of course, of course any progress and on the 47th, I think Jean Paul answered it where it's part of our backbone strategy to evaluate transfer off.
As a potential combination partner with multiple modalities being used in lymphoma treatment and that of course includes anti-city 47,000 molecules and Jean-Paul said, we it's at the back of the back of our mind and we will continue to evaluate opportunities here.
That's helpful. Thank you very much. Thank you.
Very turned back to you.
I think you can put the cold. Yes, so I was just sent back to you to wrap up. Today's call.
Ladies and gentlemen, this concludes today's conference call. If any of you would like to follow up. The investor relations team of my food is available for the remainder of the day. Once again, thank you for joining our call. Have a great date and goodbye.
Ladies and gentlemen, the conference is now concluded and you may disconnect your telephone. Thank you for joining and have a pleasant day. Goodbye.
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