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Medicines Co (MDCO)
Q2 2019 Earnings Call
Jul 24, 2019, 8:30 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Greetings, and welcome to The Medicines Company Second Quarter 2019 Earnings Call Webcast. [Operator Instructions] As a reminder, this conference is being recorded.
I'd now like to turn the conference over to your host, Krishna Gorti, Vice President of Investor Relations. Thank you. You may begin.
Krishna Gorti -- Vice President of Investor Relations
Thank you, operator. Good morning, everyone, and welcome to The Medicines Company second quarter 2019 conference call. I'm joined today by our Chief Executive Officer, Mark Timney; our Chief Financial Officer, Christopher Visioli; and our Chief Development Officer, Peter Wijngaard.
Earlier this morning, we issued a press release reporting our second quarter 2019 financial and operating results. The press release is available in the Investor and Media Relations section of our website.
Before we begin, I'd like to remind you that our discussion during the call will include forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those indicated by those forward-looking statements. Additional information regarding these risks and uncertainties is discussed under the forward-looking statements legend in this morning's press release, as well as in our periodic reports filed with the Securities and Exchange Commission, which can be obtained from the SEC or by visiting the Investor Relations section of our website.
During today's call, we will also discuss certain financial measures that were not prepared in accordance with the US Generally Accepted Accounting Principles. Please refer to this morning's press release for a reconciliation of these non-GAAP measures to the most directly comparable GAAP financial measures.
With that, I'll now turn the call over to Mark. Mark?
Mark Timney -- Chief Executive Officer
Thank you, Krishna. Good morning, everyone, and thank you for joining us today. Before I discuss the quarter, I'd like to remind us all why we're here. The millions of people worldwide who continue to die as a result of the world's number one killer, cardiovascular disease. Atherosclerotic cardiovascular disease or ASCVD is the leading contributor to morbidity and death due to cardiovascular disease and its root cause cumulative exposure to elevated LDL cholesterol is also the most readily modifiable risk factor. Despite the widespread availability and use of proven LDL-lowering therapies, notably statins, many people with ASCVD and not meeting treatment goals. At The Medicines Company, we believe there are two critical unmet needs. First, additional LDL-C lowering is needed so that ASCVD patients consistently reach their goal and avoid cardiovascular events. Second, underlying this first need is poor patient adherence to LDL-C lowering therapy.
Entering the third quarter of this momentous year for The Medicines Company and inclisiran, we continue to make steady progress, keeping a sharp focus on highly disciplined execution. We're moving closer to our goal of realizing the intrinsic value of inclisiran, which we believe has the potential to fundamentally change the treatment of cardiovascular disease. Inclisiran is the first cholesterol-lowering therapy in the siRNA class. In phase 2 studies inclisiran has shown clinically significant LDL-C reductions greater than 50% on top of optimal background lipid-lowering therapy and has the potential to deliver durable and potent effects through a six-month of dosing interval. This unique twice a year dosing regimen administered by a healthcare professional can circumvent many of the challenges around adherence to existing therapies. The twice a year dosing also aligns well with the common physician practice of twice a year appointments with ASCVD patients. Based on the durable and potent efficacy, there is extremely high potential for significant cardiovascular outcome benefit with inclisiran, which also has multiple other advantages, such as no requirement for cold chain storage and a relatively simple, scalable, low cost manufacturing and supply chain.
Now, let me focus on the quarter, which was busy and exciting. During the second quarter, the Company launched a public offering of shares of its common stock and received net proceeds from the offering of approximately $161.6 million. We believe the net proceeds from the offering, combined with the existing cash, materially extends our cash runway well into the second half of 2020 and enhances the Company's strategic financial flexibility. Chris will go into more detail later into the call.
Now, turning to the clinical development program. We continued our strong momentum and execution during the second quarter, where we successfully advanced inclisiran in the pivotal ORION Phase 3 trials. The pivotal Phase 3 studies are ongoing and on track. We expect to communicate top line results upon completion of each trial. As previously disclosed, we expect to start reporting Phase 3 readouts in the second half of the third quarter of 2019. In line with that expectation, we submitted a promissory abstract to the European Society of Cardiology for a late breaking science session to present efficacy, tolerability and safety data from ORION-11. That abstract was accepted for presentation on Monday, September the 2nd at 9:22 AM Central European Time.
Last week, the Independent Data Monitoring Committee reviewed unblinded safety and efficacy data from the Phase 3 trials for the seventh time as planned and recommended continuation of the trials without modification of the protocols. At the time of the seventh IDMC review, substantially all randomized patients had been treated with four doses and to date more than 3,500 patient-years of inclisiran safety data had been accumulated in the ORION program.
Our ongoing review of blinded data to date from the Phase 3 trial show no material safety issues, and the emerging data are at least as favorable as those generated from the ORION-1 Phase 2 study and the ORION-3 open-label extension study. It is worth noting that the inclisiran development program is the industry's largest siRNA program, targeting atherosclerotic cardiovascular disease.
Patients who have completed their respective Phase 3 studies and now enrolling into ORION-8, an open-label, long-term extension study where patients completing ORION-9, ORION-10 and ORION-11 will receive inclisiran for three years to evaluate the efficacy, safety and tolerability of long-term dosing. Enrollment of patients into the ORION-4 cardiovascular outcomes trial is also ongoing and remains on track. As a reminder, we plan to complete enrollment within one to two years.
During the second quarter, we brought forward new data and analysis for presentation and publication at medical conferences in May. During the late-breaking clinical trial session at the National Lipid Association Scientific Sessions in Miami, we presented interim results from the ongoing ORION-3 open-label extension study, which showed that twice a year dosing with inclisiran sodium 300 milligrams resulted in consistent lowering of LDL cholesterol by more than 50%, with overall follow-up of up to three years. Inclisiran was well tolerated and no material safety issues were observed in the study.
During the 87th European Atherosclerosis Society Congress in Maastricht, Netherlands, the Company presented a combined analysis of safety and efficacy data in renal impaired patients from ORION-1 and ORION-7 during an oral abstract session. The analysis demonstrated that patients across a range of renal functional levels achieved consistent reductions in LDL cholesterol with no dose adjustment necessary for patients with renal impairment and no safety concerns with using inclisiran in patients with severe renal impairment. Importantly, this analysis allowed inclusion of such patients into ORION-10 and ORION-4.
Also, during this Congress, the Company presented as a late-breaking abstract results from the Phase 2 ORION-2 pilot study in patients with homozygous familial hypercholesterolemia, a genetic disorder characterized by very high levels of LDL-C and early onset of cardiovascular disease. Those results showed that inclisiran provided durable reductions in LDL-C levels up to day 180 without the need to increase the dose of inclisiran or change the frequency of dosing.
Our ongoing robust pre-commercialization work has further increased our excitement around inclisiran's profile and potential. The team's planning has been informed by a wealth of insight-driven analysis centered on patients, providers, health systems and payers that comprise the healthcare ecosystem. We are working with industry leading partners to conduct several rounds of qualitative and quantitative market research globally. The early feedback on the target product profile for inclisiran has been very positive across stakeholders, who see the game-changing potential for this first-in-class siRNA therapy to deliver durable and potent-lowering of LDL cholesterol.
I'll speak more about initial feedback from payers. We secured input from senior decision makers at health plans and health systems in the US, the European Big Five and Japan. There is general agreement among payers in several important areas that support inclisiran's strong value proposition for patients requiring lipid-lowering therapies. Messaging related to disease burden, as well as clinical efficacy and safety for inclisiran has resonated well with decision makers across all markets. They see how a product with inclisiran's profile can help address the overwhelming unmet needs that contribute to the world's leading cause of death. Low adherence to existing therapies is seen as a significant driver of unmet need, and inclisiran's dosing profile is viewed as a potential solution to help circumvent the challenges of treatment adherence by improving therapeutic coverage and persistence.
Looking a little deeper into what differentiates inclisiran, this important stakeholder group is twice a year dosing, healthcare practitioner administration and the ability to significantly lower LDL-C over a long period of time as core value drivers. There is strong feedback on the possibility for inclisiran to deliver a positive treatment experience through twice a year dosing, administered to the patient by a healthcare professional, which aligns with common approaches to care for patients with ASCVD, including the frequency of follow-up office visits.
And lastly, payers are receptive to our focus on patient affordability and attempts to create an environment that responsibly supports access to all patients who could benefit from inclisiran. These discussions reinforce our confidence in inclisiran is the first-in-class cholesterol-lowering siRNA, offering a vastly different value proposition compared to any other LDL-C lowering option. We'll continue to have more engagements with the full range of stakeholders and we'll continue to analyze the feedback. We look forward to providing more information about this and other pre-commercialization work as we head through the second half of 2019.
The opportunity to help people simply and dramatically lower LDL-C and therefore, live healthier lives and the magnitude of the unmet need and health challenge speaks to the potential market opportunity for inclisiran. The numbers of high-risk under-treated patients with the ASCVD and FH requiring lipid-lowering therapies is staggering. In the US alone, we believe nearly 12.7 million patients could benefit from inclisiran and on a global basis that number could double. We are confident in the promise of inclisiran to significantly lower LDL-C and address long-standing adherence challenges for millions of people.
I'll now turn the call over to our Chief Financial Officer, Chris Visiol, who will cover our financial results for the second quarter. Chris?
Christopher Visioli -- Chief Financial Officer
Thank you, Mark, and good morning, everyone. During the second quarter of 2019, we continued to execute the plan. As Mark highlighted, our recent equity offering raising proceeds of $161.6 million, we believe materially extends our cash runway well into the second half of 2020 and enhances the Company's strategic financial flexibility.
Research and development expenses were $28.1 million, including $2.4 million in stock-based compensation expense in the second quarter of 2019 compared to $30.3 million, including $1.2 million in stock-based compensation expense for the same period in 2018. R&D expenses for the quarter included continued costs associated with pivotal ORION Phase 3 clinical programs, inclisiran manufacturing development work, progression of enrollment in the ORION-4 CVOT program, the continued transition of patients from the pivotal programs into the ORION-8 extension study and headcount associated with R&D.
SG&A expense was $19.9 million, including $3.3 million in stock-based compensation expense in the second quarter of 2019 compared to $21 million, including $3.4 million in stock-based compensation expense for the same period in 2018.
Our cash and cash equivalents at the end of the second quarter was $319.3 million, which we anticipate will enable us to fund operating expenses well into the second half of 2020. We look forward to the pivotal Phase 3 data readouts that are right around the quarter.
With that, I'll turn the call back over to Mark. Mark?
Mark Timney -- Chief Executive Officer
Thanks, Chris. So in summary, the Company is going into a catalyst-rich second half of 2019, which include sequential release of top line data readouts for ORION-11, ORION-9 and ORION-10 starting in the second half of the third quarter. Submissions to Congresses and preparation of publications in peer-reviewed journals, completion of validation of manufacturing batches for commercialization in the third quarter and anticipated US NDA filing in the fourth quarter. In parallel, pre-commercialization works ongoing and affirms the highly competitive profile of inclisiran.
We believe the net proceeds from the recent public offering, combined with the existing cash, materially extends our cash runway well into the second half of 2020 and enhances the Company's strategic financial flexibility. We believe inclisiran could become a game changer in cardiovascular care and help to overcome many of the existing barriers in the fight against cardiovascular disease, the world's leading cause of death.
With that, we thank you for listening. I'll turn the call back over to Matt, the operator, so we can take some questions.
Questions and Answers:
Operator
Great. Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question is from Umer Raffat from Evercore ISI. Please go ahead.
Umer Raffat -- Evercore ISI -- Analyst
Thanks so much for taking my question. I have one and a follow up, if I may. First, in the past when you've described the blinded safety looks, you've always mentioned that it's tracking at least as favorable as the data from Phase 2. And I noticed today you've added on language to include it's tracking at least as favorable as data from Phase 2 and the ORION Phase 3 open-label extension studies. Should we be reading into that that you've expanded the scope of what you were referencing as what it's tracking favorable relative to? That's one.
And the second one is, maybe one for, Mark, when it says no material safety issues, how should we think about that as we're heading into the pressure release? Thank you very much.
Peter Wijngaard -- Chief Development Officer
Hey, Umer, this is Peter. So when we announced the ORION-3 results, we made it clear in our disclosure that the results we've seen in ORION-3 are consistent with results we've seen in ORION-1 just for the longer term follow-up of up to three years. So I don't think you need to read anything more on that, that this is consistent from ORION-1 to ORION-3, and what we're seeing in blinded review of the Phase 3 program.
Mark Timney -- Chief Executive Officer
Handle the safety -- no material safety issues as well, Peter, fairly straightforward.
Peter Wijngaard -- Chief Development Officer
Yeah. It's sort of the same things, we have established a safety profile in Phase 2 in ORION-1, it's now extended out to three years with ORION-3. Again, we look at the blinded safety information from Phase 3. So you look at the aggregate event rate that you see there and again, we are consistent with what we have seen in ORION-1 and in ORION-3 and what is sort of expected with the background of the cardiovascular disease that these patients have. So that's what define no material safety as we've said before.
Umer Raffat -- Evercore ISI -- Analyst
Got it. Thank you very much and good luck into press release.
Mark Timney -- Chief Executive Officer
Thanks, Umer.
Operator
Our next question is form Joseph Schwartz from Leerink. Please go ahead.
Dae Gon Ha -- SVB Leerink -- Analyst
Good morning. I appreciate you taking the question. This is Dae Gon dialing in for Joe. So, one question and one follow-up for me as well. Just based on our conversation with investors, there are several recurring questions that I wanted to get your take. So, first question is, on your prior call in Miami held with Dr. John Kastelein, I remember he's saying he predicted about 54% LDL reduction on Day-510 and the consequent improvement in MACE. So, since ORION-4 data aren't expected for several more years and we're expecting the sequential data in the third quarter. Wondering what is the lower bar in your view on the LDL reduction that could materialize. And what is it from the KOLs that they would like to see as a bare minimum?
And as a follow-up, we're still hearing investors cautious on the PCSK9 market. So, can you frame for us based on either commercial PCSK9 monoclonal sales or your own market research that, Mark, you alluded to in your prepared remarks? What is the industry's appetite for a six-monthly subq drug like inclisiran? Thanks.
Mark Timney -- Chief Executive Officer
Thanks, Dae Gon. I'll let Peter handle the first part and then I'll continue with the second.
Peter Wijngaard -- Chief Development Officer
Yeah. Thanks, Joe. So, if you go back to the ORION-3 data that we presented at NLA, it is sort of combined with ORION-3, six years -- three years of follow-up and up to six doses of inclisiran giving in individual patients. And what was striking of the ORION-3 data: one, we got consistently more than 50% of LDL-C reductions; and two, the LDL-C response was identical or consistent every single time you gave inclisiran. So, we anticipate that consistency is maintained over the long-term.
In the population that we had in ORION-3, we had on average of 60 milligram per deciliter of absolute reduction in LDL-C. Of course, it's different by the baseline that this patient population had. But that is -- so the number that you have to keep in mind if you want to extrapolate that to what you could expect in an outcome studies in the long-term.
Mark Timney -- Chief Executive Officer
And if I can -- Dae Gon, I'll cover the couple of questions, which are more around the commercial impact. When you think about sort of the lower bar, certainly, our -- in our research we presented a profile, which is 50% or greater in our market research in terms of LDL-C lowering. That is being received extremely positively. However, it's much more around the whole profile where we're getting feedback, the twice a year dosing, actually putting the control back into the hands of the physician is coming across is very, very positive.
And I think this speaks to the second part of your question around the six-month dosing. The beauty of this and what we're hearing in the research is that, these high-risk ASCVD patients are seeing their healthcare practitioners twice a year routinely and the majority of them anyway. And we're seeing that as very positive, not only for the physician, again, who feels that they've got control and also giving a purpose for the visit. But it's sort of guaranteed their adherence, but also for the patient that they're feeling a reassurance that they know they've got LDL-C lowering on board as they try to achieve these treatment goals also.
Dae Gon Ha -- SVB Leerink -- Analyst
Great. Thanks for taking the questions and good luck.
Mark Timney -- Chief Executive Officer
Thank you.
Operator
Our next question is from Jessica Fye from J.P. Morgan. Please go ahead.
Jessica Fye -- J.P. Morgan -- Analyst
Great. Good morning. Thanks for taking my question. Maybe building a little bit on the last topic. I know you can't comment on any ongoing discussions or strategic interest. But can you just give us a sense of the types of players who could be interested in owning this asset? And what specific attributes of inclisiran you think they might find attractive whether it'd be the revenue potential or potential COGS advantage, et cetera? Just sort of hoping you could get us -- give us a sense of whether you think there could be a competitive process to own this asset?
Mark Timney -- Chief Executive Officer
Hi, Jessica. Thanks for the question. Obviously, I can't comment on any sort of speculation. As you know, we've always said that we would seek to have strategic optionality and flexibility in whatever we're doing, and obviously, having a range of options is very important to us. What we can say is that, if you look at the profile and if you think about the profile of inclisiran, that is going to give you potency, durability sort of that consistent lowering of LDL-C. Then you have on top of that the fact that you're also going to put the control back into the hands of the healthcare practitioner, which will help, certainly, with adherence and, obviously, the reduction in the amount of times that you have to take this medication. You start to get a very different profile. Coupled with that, we're starting to have conversations, which are very different with payers that I've experienced before around an LDL-C lowering medication, where they're starting to look at specific patient types and groups of populations, which is being quite -- and this is why we talk about it being game changing because they're starting to consider it in -- around a -- the discussion turns to population health very quickly.
So, I mean, you have probably answered the question yourself, as you gave your examples. You've got a differentiated profile, you've got a very attractive COGS. And so, therefore, you've got the flexibility in how you position this, certainly from patient affordability. It's very, very exciting for, I would imagine, a range of companies.
Jessica Fye -- J.P. Morgan -- Analyst
All right. Thank you. And maybe just one follow-up on just the cadence of news flow we can think about over the back half of the year. So, based on the projected completion of these Phase 3 trials, do you anticipate all three of them will be presented at conferences by year end? Or is it possible we might have to wait until ACC, for example, to see some of the data details?
Peter Wijngaard -- Chief Development Officer
Hi, Jessica. This is Peter Wijngaard. As we have stated, the first one will be presented at ESC, the second one following 9 and 10. As you remember, enrollment was finished in this time span of the three studies of six weeks earlier last year. We anticipate those results to come out sort of the same sequence in roughly about the same time span. So they would be ready for major conferences later in the year. Obviously, we'll have to go through the process of abstract submission and acceptance. So that's the part we don't know yet.
Jessica Fye -- J.P. Morgan -- Analyst
Great. Thank you.
Operator
Our next question is from Joel Beatty from Citi. Please go ahead.
Joel Beatty -- Citigroup -- Analyst
Hi, thanks for taking the question. The first one is on the top line data from the first trial reading out at ESC. Is there any potential for top line data to come sometime before ESC?
And then, the second follow-up question is, could you discuss where you're currently at in terms of hiring for commercialization and any plans to wrap that up in the near-term? Thanks.
Mark Timney -- Chief Executive Officer
Peter, do you want to add a little bit to the timing?
Peter Wijngaard -- Chief Development Officer
Yes, I can answer the first part of your question, Joel. As we said in the call earlier, as well as previously, we will report top line data from the three studies as they come available to us. So also ORION-11 will become available before ESC. So we will do a top line announcement prior to ESC, but full results will be then disclosed at ESC in the late-breaking scientific session on Monday, September the 2nd.
Mark Timney -- Chief Executive Officer
With regards to -- Joel, thanks for the question. With regards to commercialization planning, we're about really six, seven months into it now. Everything that's ongoing is, as you would expect in a normal pharma company, we're doing extensive work around research, we're doing extensive work around the scientific platform. It really is pre-commercialization. We're very early in that process. And it's all going to plan and it's just said on the call, we're very, very excited about what's coming back in terms of our research, and it's really affirming the competitive profile that we have for inclisiran, very exciting.
Joel Beatty -- Citigroup -- Analyst
Great. Thank you.
Operator
Our next question is from Chris Shibutani from Cowen and Company. Please go ahead.
Chris Shibutani -- Cowen and Company -- Analyst
Great. Thank you very much. Two questions, if I may. On the outcome study, I think you mentioned that there was potential for a range of enrollment completion in one or two years. Can you comment upon what the rate limiting factors are for that?
And then number two, you discussed some of the feedback that you had from payers US, Europe and Japan. Can you comment about what kind of assumptions the payers were contemplating from a pricing standpoint? And as well, how they thought about the potential for patients using inclisiran either new to therapy versus the possibility of benefit of switching over patients on monoclonals, which may be more priced higher? If you could comment on the considerations that went into the thinking of the payers that you've been discussing, would that be helpful?
Mark Timney -- Chief Executive Officer
Tight. Thanks, Chris. I'll let -- Peter, will talk to you about the outcomes and then I'll take the commercial questions.
Peter Wijngaard -- Chief Development Officer
Yes. Thanks, Chris. So you probably remember that ORION-2 -- ORION-4 is being conducted in two countries, the UK and the US. We are using a streamlined approach to conduct this study. At average, we're using pre-screening methodologies to identify patients and potentially eligible for the study and then they will be going to the trial sites to be screened and ultimately, if fulfilling the inclusion and exclusion criteria, they will be involved into the study and then follow-up for the duration of the study. So there is no typical or any different rate limiting factors that you would have in any of these types of trial. It comes down to identifying the sites, which we have already done, activating them and then having the patients come to the scheduled visits for the screening procedures and if selected positively, then can be enrolled and treated in the study. So fairly standard, and that's why we based a one to two years of enrollment period on.
Mark Timney -- Chief Executive Officer
Thanks, Peter. And with regards to the commercial question, with regards to payers, Chris. As I said, we've secured the input from senior decision makers, at health plans, health systems in the US, European top five countries and also Japan. Strong general agreement among payers in several important areas that support inclisiran's strong value proposition for patients who do require this additional lipid-lowering therapy. I can say that, while we do not -- at this stage, it's very early, we do not disclose any pricing. The payers are very receptive to our focus on patient affordability. And all of our attempts really to create that environment, that responsibly supports access to all the patients who can benefit from inclisiran.
With regard to the types of patients that we would be targeting, and again, very early in our work. However, the early feedback is very clear to us, that suggests that inclisiran is essentially, it's a new product and a new class and will be a market of one. It's a highly differentiated and very clear to us that we should not just be positioned with regards to the monoclonal antibodies and that the opportunity is much greater.
Chris Shibutani -- Cowen and Company -- Analyst
Great. Thank you.
Operator
Our next question here is from Madhu Kumar from Robert W. Baird. Please go ahead.
Madhu Kumar -- Robert W. Baird -- Analyst
Yeah. Thanks for taking our questions. So we're just curious in kind of a big picture perspective, what you think oligo manufacturing capacity looks like now and over the next few years? So, recognizing maybe a long-term COGS benefit for inclisiran, do you think kind of manufacturing capacity for oligo drugs like inclisiran is opt is not for the kind of like first two years of a potential inclisiran launch?
Mark Timney -- Chief Executive Officer
Yeah. Madhu, this is Mark. Thanks for the question. We've -- obviously, by third quarter we will have our commercial scale in place. We've got a very strong partnership in place with Agilent. We've, obviously, got very clear plans and pathway to our initial launch and then to subsequent scaling. We believe we've got sufficient access and a runway for large numbers of patients, which we believe will be applicable to have access for inclisiran. We've focused very clearly on a target number of patients in these very early years, which we would like to gain access to and we've got contracts and assurances and a brand new site, which is just opened for Agilent in Frederick, Colorado, which essentially will be dedicated to our manufacturing.
Madhu Kumar -- Robert W. Baird -- Analyst
But to that end, would that kind of target number you envisioned, say, within the ballpark of where Repatha and Praluent are selling today? Or is it significantly larger than that? I mean, obviously, you can't give hard numbers, but kind of what are you thinking as an initial target number for the current rounds of manufacturing capacity?
Mark Timney -- Chief Executive Officer
Yeah. Let me answer that similar to the way I answered Chris' question. It's very clear in the feedbacks that we've got a very differentiated profile and inclisiran we will be seen as a market of one. Therefore, our numbers in terms of manufacturing capacity are substantially different as to what you would see with the antibodies.
Madhu Kumar -- Robert W. Baird -- Analyst
Okay. Thank you.
Operator
Our next question is from Paul Choi from Goldman Sachs. Please go ahead.
Paul Choi -- Goldman Sachs -- Analyst
Great. Good morning and thank you for taking our questions. Recognizing that the political landscape is shifting almost on a daily basis here. Could you maybe comment on how you're thinking about potential and theoretical exposure to Medicare, particularly in Part B exposure as you think about the dispensing and prescribing within the physician office going forward? And just how you're thinking about sort of pricing buckets for that particular population?
Mark Timney -- Chief Executive Officer
Yeah. Thanks for the question, Paul. I mean, look, obviously a very sensitive area and there are lots of moving parts in this space at the moment. The beauty for inclisiran is, it's going to be applicable for a range of different types of reimbursement and access that provides us with tremendous, tremendous flexibility. However, I would say, for us, it's very early for us to be thinking about all of the changes that are taking place in D.C. at the moment. As you know, many of these will not come to fruition and some will. We're working very closely with policy advisors down in D.C. and sort of keeping track of the changes that would affect inclisiran. But it's very early for us to be able to actually say anything, since we really are -- we're 18 months for launch and do have a high degree of flexibility to anticipate and respond to those changes. That's the beauty of being a one product Company. We can position that in however way we want as those changes unfold.
Paul Choi -- Goldman Sachs -- Analyst
Great. Thanks for that. And then as a follow-up, can you maybe just confirm for us either on the clinical or non-clinical side, whether you have any other outstanding CMC or any manufacturing validation processes or tests you need to do before you submit your NDA filing?
Mark Timney -- Chief Executive Officer
Peter?
Peter Wijngaard -- Chief Development Officer
As we've said before, so obviously we'll have a full NDA file, which includes manufacturing and non-clinical activities, including the validations you have referred to. We said before for the program to complete the NDA, the clinical program is on critical path, not the CMC part, not the non-clinical part. So we're on track for the totality of the NDA for submission -- for the NDA and the FDA by the end of the year and for the MAA for Europe in Q1 of 2020.
Paul Choi -- Goldman Sachs -- Analyst
Great. Thanks for that and good luck.
Peter Wijngaard -- Chief Development Officer
Thank you.
Mark Timney -- Chief Executive Officer
Thanks, Paul.
Operator
Our next question is from Yasmeen Rahimi from ROTH Capital Partners. Please go ahead.
Yasmeen Rahimi -- ROTH Capital Partners -- Analyst
Hi, team. Two questions for you. Question one for Peter. Peter, we know that the ORION-11 study has 12.5 patients that have high-risk equivalent. How do you think the transferability will be with that nuance from the ORION-11 data to ORION-10?
And then the follow-up is, congrats on getting into the European Society of Cardiology meeting for your presentation. Why was it so critical that you needed to really secure a presentation at this time? Deadline for AHA for late-break is August 14. So should we expect it to see all data potentially at the upcoming AHA meeting? And then, what is sort of the feedback you're getting from physicians? Is there a difference between US-based physician versus European? And thank you for taking the question.
Peter Wijngaard -- Chief Development Officer
Okay. Let me start with your middle question on AHA. You are correct, the absolute deadline is August 14. So we're working toward the abstract submissions in a similar way that we did that for ESC. But as I said before, it's dependent on whether the abstracts will be accepted by the review committee of the societies, whether we will be able to present the data at that conferences later in the year. I can't comment on that specifically. ESC is the first one after we have the first study readout as we have now disclosed, we felt that it was important to present the results as early as possible as they come known to us. That's why we executed the plan in that particular way.
With respect to your first question, so there is regulatory guidance both from FDA and from Europe with respect to the various populations. As has been done in previous lipid-lowering development programs, we essentially followed that guidance and therefore, we did the study in ORION-11 in Europe with the two populations, ASCVD and ASCVD-risk equivalent because they have essentially the same risk of cardiovascular risk and subsequent events. So that's why both populations are important. And in the US, the guidance is more focused on ASCVD, hence, we did the entirely dedicated ASCVD study in the US. It's standard procedures that we followed here. We're executing accordingly and we will make these submissions to regulators in the same standard way.
Mark Timney -- Chief Executive Officer
Hi, Yasmeen, let me sort of touch on some of that first question, then I'll go to the second part of the question. I'll just say it is fair to say that I've been highly consistent since I came into the Company that I would like to get this data out as quickly as possible. That objective has not changed. This is very important data for a very high-risk group of patients. And the sooner we can communicate that, the better.
I would say, in terms of our research that we're seeing across the US as compared to the EU and the rest of the world, the only subtle difference that we're really seeing, I mean, there's high consistency about the differentiated profile, high consistency about the value of twice a year dosing, physician administered, healthcare practitioner administered and also the adherence benefits, coupled with the durability, the ability to stay low over that six-month period, that is sort of garnering its -- the feedbacks coming back of confidence of reassurance, it's very, very reassuring.
However, I will say the subtle differences is the way that they think about their populations. The majority certainly ex-US think of population health, how does this work within, for example, our country when we've got X 100,000 or X million patients who could be applicable? How do we think about gaining access and what does that look like? And, obviously, that is much more fragmented within the US system.
Yasmeen Rahimi -- ROTH Capital Partners -- Analyst
Thank you, team and best of luck as we're getting into the data readout.
Operator
Our next question here is from Akash Tewari from Wolfe Research. Please go ahead.
Akash Tewari -- Wolfe Research -- Analyst
Hi. So can you expand a bit on the EU opportunity for inclisiran and how payers would view your asset versus the traditional PCSK9? And then, also outside of the initially high WACC [Phonetic], what other commercialization areas you feel Amgen and Regeneron made when launching their products? Thanks.
Mark Timney -- Chief Executive Officer
Thanks for the question, Akash. So, I will caveat this and it probably will form the majority of my response here. The EU and any of our commercial research is still early. The early feedback, as I said, is very positive. We haven't really dug into the size of the opportunity yet, as we're working our way through. We have payer and system research. We're very early in our physician research within the EU. But I'll just reiterate, the differentiated profiles coming out strong and that conversation quickly turns to what is that patient population? We have deeper understanding in various countries, which for competitive reasons, I will not go into. But it's -- let's just say, it's substantial opportunities that we have to try to help governments figure through for the amount of patients that they have.
In terms of the antibodies, obviously, I don't want to comment about what they did and what they did right and what they did wrong. I think for us and I want to be very clear that the feedback supports exactly our positioning that inclisiran is going to be a market of one. It's a totally different value proposition, which has advantages and can be thought about very, very differently. So, we are -- you touched on, obviously, their initial pricing, but for me, this is about -- we think about patient affordability. But then there is much more to this, you've got to be able to gain access further to the right group of patients. So there is a whole spectrum in how any company should think about launching such a product as inclisiran, which is -- this is -- you have to understand how beneficial the product could be for a large group of patients. So therefore, our launch structure is and thoughts and thinking and pre-commercialization work would be vastly different to what the antibodies would have been thinking.
Akash Tewari -- Wolfe Research -- Analyst
Got it. Thanks so much.
Operator
Our next question here is Mayank Mamtani from B. Riley FBR. Please go ahead.
Mayank Mamtani -- B. Riley FBR -- Analyst
Good morning. Thanks so much for taking my question. I have two for Peter and just one for Mark. Just a follow-up to the questions that have been asked before. Just understanding that ORION-11 top line release that precedes ESC. Is it different than the embargo rules relative to ACC or AHA, which may allow you to have more or less granularity, particularly on the baseline characteristics, if you may?
And then second, on the clinical side, as I understand, ORION-11 obviously closely mimics ORION-1 baseline, given the European side focus. But I think you made a comment that it lacks the more renally impaired group. So anything else you could comment on comparing the difference in baseline characteristics for ORION-11 relative to ORION-10 and ORION-4 in terms of underlying liver or renal disease?
And then, for Mark, I know you talked a lot about Part B versus Part D. But just on the characteristics of poorly adherent patients. Is there anything you are identifying that is maybe unique to that subgroup maybe across US and EU? And how maybe the antibodies are doing in that particular segment?
Peter Wijngaard -- Chief Development Officer
Thanks, Mayank. I'll take your first two question. So, generally, the embargo rules that the major societies has like ESC, ACC and AHA are very similar. And, obviously, they recognize the need that we are as a public and a small company, so we will be discussing with them what we can and what we cannot say in the top line results, once we have the data and then we will decide what exactly will be included. But I think you can look up the rules of the embargo because they are on the website of the societies and that will give you sort of general guidance of where they are going with what can and what cannot be said.
With respect to the baseline characteristics, the only thing that we have disclosed on that so far is pointed out by you correctly, ORION-11 is done in Europe and has ASCVD patient population and ASCVD-risk equivalent. It was similar to ORION-1. We have disclosed the baseline LDL-C level of all the Phase 3 studies in our NLA presentation in May and there was 110, 112 and 160, respectively, the larger one for ORION-9, which is the heterozygous efficacy study. They expect to have a higher baseline. So 10, and 11 are similar, even though they have slightly different patient populations. And I may point out that that baseline ORION -11 and ORION-10 is also slightly lower baseline we had in ORION-1, which was around 125 across the dosing groups that we tested in ORION-1.
The only other thing that we have disclosed to your point, and you made it a comment yourself already is that, the ORION-7 study allowed us to include severe renal impairment patients in the Phase 3 program toward the end, once ORION-7 was completed, that was not possible in ORION-1, because we didn't have the data at that point in time. That's all the things that we have sort of said publicly on the baseline characteristics of the studies.
Mark Timney -- Chief Executive Officer
Thanks, Peter, and thanks for the question. So the -- if I understand it correctly, is there anything sort of unique in patient subgroup who are non-adherent or anything that we're seeing in the US or across the rest of the world? The short answer in terms of certainly the feedback that we've received in our research from patients is very clear. They want to get to go, even the non-adherent patients, they're frustrated. They've hadn't a CV event. It's pretty clear that the majority understand the risk that they are at, but they're frustrated. They're frustrated that they can't get to go or they frustrated in terms of getting access to the right medications, and that's a real challenge. So that comes through really strongly.
Now, I'm not saying that it's all patients, because it's very clear to us in the research and we see two-thirds of patients regardless will stop taking their medication, oral medication and statins after one year. That's two-thirds of patients. That's a very, very significant number. And the research that runs beside that is that the healthcare practitioner, the fact that they are then taking control and taking this issue away from patients who are trying to do the right thing is where the benefit applies.
Mayank Mamtani -- B. Riley FBR -- Analyst
Is there anything that the payers could potentially also do in your view that could allow for maybe earlier utilization over other options? Just recognizing proactively there is a subgroup that is just going to be very poorly adherent and hence the economic burden on the system group?
Mark Timney -- Chief Executive Officer
Yeah. It's a great point. It's certainly come through in our research from payers, they identify this group regardless of really their risk profile, that there is just a group of non-adherent patients that they also want to get under control. They understand the benefit of that and they've spoken to us about it. And it's very clear that they're looking for our solution. So, I do think there is a role for all stakeholders. And that's sort of the approach that we're taking in pre-commercialization.
Mayank Mamtani -- B. Riley FBR -- Analyst
Great. Thanks for taking my question and good luck for the data release.
Operator
Our next question here is from Jay Olson from Oppenheimer. Please go ahead.
Jay Olson -- Oppenheimer & Co. -- Analyst
Good morning and thanks for taking my question. I'm curious if you saw a recent publication in AHA journals, that analyzes patients with limited access to PCSK9 therapy, it shows increased risk of cardiovascular events. And I was wondering if that type of analysis could be used to strengthen the value proposition for inclisiran and potentially help you create a more compelling argument with payers. Thank you.
Mark Timney -- Chief Executive Officer
Thanks for the question, Jay. And yes, we saw the article, very recent article. I think it was -- I think we only saw it yesterday or the day prior. Very -- I mean, for us, obviously, very timely and it obviously it dovetails so well into our existing research that's coming back. I think you answered the question yourself. I think it would -- it's certainly beneficial. However, for us, this is -- it's so important to have the understanding that this is a different product to what it termed PCSK9 inhibitors, and I -- the monoclonal antibodies have wonderful science, it's great science and it's validated and it validated the target. Inclisiran's differentiated profile is coming through, it's so different. Therefore, we are -- certainly in our research, we're picking that up. And I think access is a critical component when you have a large number of patients who could be applicable to this treatment, so we can have different discussions. But it's certainly -- the easy you make those that access or the better it can become. Then you have to solve the adherence issue. You can get a 100% access for a product but if the patients are still not going to take the product, you still don't get the benefit and that's where inclisiran comes in.
Jay Olson -- Oppenheimer & Co. -- Analyst
Great. Thanks for taking the question.
Operator
Our next question is a follow-up from Umer Raffat from Evercore ISI. Please go ahead.
Umer Raffat -- Evercore ISI -- Analyst
Hi. Thanks so much for allowing me a follow-up. My question was, I just wanted to confirm this. So, ORION-11 was -- had the last patient randomized on 29th of January. So Day-510 for that patient would have meant June 23rd for the primary endpoint. So, is it safe to assume the trial has readout internally and statisticians are working on it?
Peter Wijngaard -- Chief Development Officer
Thanks, Umer, for your math. Your math is not exactly correct. There is always a little bit of flexibility in the visit windows that you have to factor in. Then you have to factor in data base cleaning before you can lock the database and run the analysis. As we've said before, the trials are on track and are ongoing. So, we are -- where we are and we will release the data as it comes available to us in the top line and presented at Monday morning 9:22 September 2nd in Paris at ESC.
Umer Raffat -- Evercore ISI -- Analyst
Got it. But just to be clear, Peter, the trial has -- it may be in the database cleanup stage, but the trial has officially met the -- we're past the primary endpoint, correct? Meaning management is not aware, but internally there might be a cleanup going on.
Peter Wijngaard -- Chief Development Officer
As I said just before, the trial is ongoing and on track. I can't specifically comment on where we are exactly on an individual last patient [Technical Issues].
Umer Raffat -- Evercore ISI -- Analyst
Got it. Thank you very much.
Operator
This includes the question-and-answer session. I'd like to turn the floor back to management for any closing comments.
Mark Timney -- Chief Executive Officer
Okay. Thank you, Matt, and thank you all for your questions, and wish us a good luck. Inclisiran is a unique profile. It's a vast global market opportunity, coupled with The Medicines Company full unencumbered commercial rights to inclisiran in all markets and market exclusivity to mid-2034 with expected extensions into 2035, you set the stage with significant shareholder value creation. Inclisiran is moving very quickly through Phase 3 trials. We're encouraged by the emerging clinical and safety profile and expect the Phase 3 data to start reading out in the second half of the third quarter.
In parallel, our pre-commercialization work is ongoing and it affirms the highly competitive profile of inclisiran. The Board and the management team are fully aligned and committed to unlocking the value of inclisiran for its shareholders and ultimately people who would benefit from this unique therapy.
So with that, I'll close the call and I'll wish you all a very good day. Thank you.
Operator
[Operator Closing Remarks]
Duration: 59 minutes
Call participants:
Krishna Gorti -- Vice President of Investor Relations
Mark Timney -- Chief Executive Officer
Christopher Visioli -- Chief Financial Officer
Peter Wijngaard -- Chief Development Officer
Umer Raffat -- Evercore ISI -- Analyst
Dae Gon Ha -- SVB Leerink -- Analyst
Jessica Fye -- J.P. Morgan -- Analyst
Joel Beatty -- Citigroup -- Analyst
Chris Shibutani -- Cowen and Company -- Analyst
Madhu Kumar -- Robert W. Baird -- Analyst
Paul Choi -- Goldman Sachs -- Analyst
Yasmeen Rahimi -- ROTH Capital Partners -- Analyst
Akash Tewari -- Wolfe Research -- Analyst
Mayank Mamtani -- B. Riley FBR -- Analyst
Jay Olson -- Oppenheimer & Co. -- Analyst
