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Medicines Co (MDCO)
Q3 2019 Earnings Call
Oct 30, 2019, 8:30 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Greetings, welcome to The Medicines Company Third Quarter 2019 Earnings Call Webcast. [Operator Instructions] A question-and-answer session will follow the formal presentation. [Operator Instructions]
At this time, I will turn the call over to Krishna Gorti, Vice President, Investor Relations. Please go ahead, Krishna.
Krishna Gorti -- Vice President of Investor Relations
Thank you, Rob. Good morning everyone and welcome to The Medicines Company's Third Quarter 2019 Earnings Conference Call. I'm joined today by our Chief Executive Officer, Mark Timney; our Chief Financial Officer, Christopher Visioli; our Chief Development Officer, Peter Wijngaard.
Earlier this morning we issued a press release reporting our third 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 U.S. 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 modern 47,000 people worldwide will guide today as a result of the world's number one cardiovascular disease. Atherosclerotic cardiovascular disease or ASCVD is the leading contributor to morbidity and death. And it's a root cause, cumulative exposure to elevated LDL cholesterol, is also the most readily modifiable risk factor. We are aligned with the increasing recognition by thought leaders of the importance of addressing cumulative exposure to LDL-C. Patient management should consider both lowering LDL-C levels and keeping them low for the remainder of one's life. Despite the widespread availability and use of proven LDL-lowering therapies notably statins, many people with ASCVD are still not meeting treatment goals. We know from our research that healthcare professionals around the world are concerned about the inability to get and maintain patients on therapy and they are seeking different ways to achieve durable and potent LDL-C reductions that address cumulative exposure to LDL-C.
As the first and only LDL-C therapy that would be administered by a healthcare professional twice yearly, we believe that inclisiran is a game changer that addresses two critical unmet needs. First, additional LDL-C lowering is needed, so that ASCVD patients consistently reach their goal, and avoid cardiovascular events. And second underlying this first need is poor patient adherence to LDL-C lowering therapy. Based on the exceptional data presented so far, we believe inclisiran is well positioned to address the significant unmet need in ASCVD, setting the stage for substantial commercial opportunity and shareholder value.
We continue to make steady progress, keeping a sharp focus on highly disciplined execution, and we believe the existing cash provides us with runway into the second half of 2020 and enable significant strategic financial flexibility. Now, let me focus on a very busy and exciting third quarter with the performance that was defined by flawless execution.
I'll begin with our clinical development program where we successfully completed inclisiran's pivotal Phase 3 LDL-C lowering trials. Each of those three studies met all primary and secondary endpoints, showing durable and potent efficacy with twice yearly dosing of inclisiran and excellent safety with no treatment related liver or renal laboratory abnormalities. At the European Society of Cardiology meeting in Paris in September, we presented the results from ORION-11. Inclisiran's first pivotal Phase 3 clinical study.
In ORION-11 twice yearly dosing with inclisiran sodium, 300 milligrams met all primary and secondary efficacy endpoints, as well -- and was well tolerated and demonstrated an excellent safety profile. For the primary endpoints inclisiran delivered a placebo adjusted LDL-C reductions of 54% at day 510 and demonstrated time-averaged placebo-adjusted LDL-C reductions of 50% from days 19 through 540. The overall adverse event profiles of the Placebo inclisiran treated groups and ORION-11 with similar with no treatment related hepatic or renal abnormalities. The results of the ORION-11 trial support the unprecedented potential of inclisiran, to deliver assurance that clinicians and patients, that LDL-C can be lowered in a sustained fashion over the long-term, with an infrequent dosing regimen and an excellent safety profile.
In addition to ORION-11, we topline the two remaining pivotal trials ORION-9 and ORION-10 in late September. Topline data for ORION-9, which is the Phase 3 clinical study in patients with heterozygous familial hypercholesterolemia or HeFH, show that the study met all primary and secondary endpoints. Inclisiran demonstrated durable and potent efficacy and was well tolerated with excellent safety, that was generally well balanced between the treatment groups with no treatment related liver or renal laboratory abnormalities.
ORION-10 at Phase 3 clinical study in patients with ASCVD mark the successful conclusion of the pivotal Phase 3 LDL-C lowering studies of Inclisiran. ORION-10 met all primary and secondary endpoints and inclisiran demonstrated efficacy and tolerability and safety that were at least as favorable as observed in ORION-11 with no treatment related liver or renal laboratory abnormalities. Detailed efficacy, tolerability and safety data from ORION-10 will be presented at a late breaking science session of the American Heart Association Annual Meeting in Philadelphia on Saturday, November 16, at 11:06 Eastern Standard Time.
The Company will also present data from the ORION-9 study in patients with HeFH, at a separate late-breaking science session of the AHA Congress on Monday, November 18, at 9:24 Eastern Standard Time. With our clinical development program is also ORION-4, our cardiovascular outcomes trial. Enrollment of patients into ORION-4 is ongoing and remains on track. We expect to complete enrollment within one to two years from the beginning of enrollment.
During the quarter we also completed manufacturing validation of inclisiran and achieve commercial scale. With this validation and the completion of the pivotal Phase 3 studies, we're progressing rapidly toward anticipated regulatory submissions. We expect to file an NDA by the end of this year and then MAA in Europe during quarter one of next year. In parallel, we continue with our robust pre-commercialization work that reinforces the transformational profile and potential of inclisiran.
Our Phase 3 data readouts further fuel our excitement in the product profile. This enthusiasm is matched by thought leaders and stakeholders keen to change the trajectory of cardiovascular disease. Our planning has been informed by a wealth of insight driven analysis centered on patients, healthcare professionals, health systems and payers that comprise the healthcare ecosystem. We've been working with industry leading partners to conduct several rounds of qualitative and quantitative market research globally.
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 cholesterol lowering small interfering RNA therapy to deliver durable and potent lowering of LDL-cholesterol and is thereby ideally suited to address the risk of cumulative exposure to LDL-C. Across all stakeholders, patients providers health plans and health systems around the world. The feedback is remarkably consistent. 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. 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.
Looking a little deeper into what differentiates inclisiran for payers, this important stakeholder group used twice a year dosing, healthcare professional administration and the ability to significantly lower LDL-C over a long period of time, as core value drivers. All stakeholders are also receptive to our focus on patient affordability and attempts to create an environment that responsibly support access to all patients who could benefit from inclisiran. These consistent and continued insights from stakeholders around the world reinforce our confidence in inclisiran, is the first in class cholesterol lowering siRNA, that offering a vastly different value proposition compared to any other LDL-C lowering option. The opportunity to help patients simply and dramatically lower LDL-C and therefore live healthier lives, and the magnitude of the unmet need and health challenges speak to the potential market opportunity for inclisiran.
The number of high-risk under-treated patients requiring lipid lowering therapies is staggering. We believe there is an opportunity for inclisiran to provide durable and potent LDL-C lowering among the more than 40 million people with ASCVD or FH across the U.S., the largest European countries, China and Japan who are currently treated with LDL-cholesterol lowering therapies but not a goal. We are confident in the promise of inclisiran is the first and only cholesterol lowering siRNA with the potential to deliver durable and potent lowering of LDL-C levels by a twice yearly dosing, that can help address the two critical unmet needs, additional LDL-C lowering and poor adherence to therapy.
I'll now turn the call over to our Chief Financial Officer, Chris Visioli, who'll cover our financial results for the quarter. Over to you, Chris.
Christopher J. Visioli -- Chief Financial Officer
Thank you, Mark, and good morning everyone. During the third quarter of 2019, we continue to execute to our operational and financial plan. Research and development expenses were $42.8 million, including $1.9 million in stock-based compensation expense and approximately $12 million related to the release of three manufacturing validation loss in the third quarter of 2019 compared to $32.7 million, including $1.4 million in stock-based compensation expense for the same period in 2018. In addition to the manufacturing validation work R&D expenses for the third quarter of 2019 included cost associated with the pivotal ORION Phase 3 clinical programs, progression of enrollment in the ORION-4 CBOT program. The continued transition of patients from the pivotal programs into the ORION-8 extension study and headcount associated with R&D.
The manufacturing validation loss will be part of our NDA filing and will be used for clinical and commercial supply pending approval. SG&A expense was $18.6 million, including $2.6 million in stock-based compensation expense in the third quarter of 2019 compared to $6.8 million including $2.7 million in stock-based compensation expense and a $7 million gain from the sale of the company's -- to branded Angiomax in the United States to Sandoz for the same period in 2018. Our cash and cash equivalents at the end of the third quarter was $255.9 million, which we anticipate will enable us to fund operating expenses into the second half of 2020.
With that, I'll turn the call back over to Mark. Mark?
Mark Timney -- Chief Executive Officer
Thanks, Chris. So in summary, The Medicines Company has entered an exciting period for inclisiran, which we believe is a class of one -- therapeutic profile that offers a vastly different value proposition compared to any other LDL-C lowering option. It is a product with substantial possibility to fundamentally reshape, the landscape of cardiovascular care.
Looking ahead to the rest of the year, we have a number of important upcoming catalysts that include ORION-9 and ORION-10 presentations at the AHA conference in November, publications of data from Phase 3 studies and pay-reviewed journals and the anticipated U.S. NDA filing in the fourth quarter.
In parallel, pre-commercialization work is ongoing and affirms the highly competitive profile of Inclisiran. The Board and the management team are fully aligned and we're committed to unlocking the full potential of interest around for its shareholders and ultimately patients who would benefit from this unique therapy. We are more confident than ever in our belief that 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 and I'll turn the call back over to Rob, so that we can take some questions.
Questions and Answers:
Operator
Thank you. We'll now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Umer Raffat with Evercore. Please proceed your question.
Umer Raffat -- Evercore ISI -- Analyst
Hi. Thanks so much for taking my questions. Mark, can you speak to any contracting work, you guys have already been doing potentially with any government agencies, U.S. or ex-U.S. what the size of that looks like? What the volume of that looks like? And what's the dollar pricing for that look like? Thank you very much.
Mark Timney -- Chief Executive Officer
Hi Umer, and thanks for the question. As you can imagine we've been in deep discussions with payers and health systems around the world, and we've tremendous optionality as we speak to them. It's too early for me to disclose any of those conversations at this point in time, they are ongoing. It's suffice to say that there is tremendous excitement around the possibility of trading large populations with a product, with the profile like inclisiran. And let me leave it there, but it's very exciting times.
Umer Raffat -- Evercore ISI -- Analyst
Thank you very much.
Operator
Our next question is from the line of Joseph Schwartz with SVB. Please proceed with your question.
Dae Gon Ha -- SVB Leerink -- Analyst
Hi, good morning. Thanks for taking my questions and congrats on all the progress. This is Dae Gon dialing-in for Joe. So Mark, two questions on the earlier payer feedback that you comment in your prepared remarks. First question is, does the potential for inclisiran to be reimbursed be Part D, Part C or population health approach has provide you with any strategic flexibility relative to the monoclonal antibodies. What are the implications for market opportunity? And second question kind of related to that perhaps more on a tangential basis is, can you share some of your market research with payers specifically where are you getting the most traction with us and what does it imply both for the potential market share of inclisiran and how inclisiran could impact the size of the overall -- the pie if you will, of the PCSK9 market? Thanks.
Mark Timney -- Chief Executive Officer
Thanks. Thanks for the question Dae Gon, let me, let me answer the second one first. Obviously payers are very important stakeholder group for us. It's very clear in the market research that we've done, that they view twice a year dosing, healthcare professional administration and the durability and the potency lowering of LDL-C is core value drivers. For them it's clear in the research that low adherence to existing therapies is seen as a significant driver of the unmet need. And inclisiran's profile is really viewed as a solution to help circumvent some of those challenges of treatment adherence. If we look a little bit deeper into some of that research, it's an important stakeholder group, but they do say that twice a year dosing is the critical piece for them.
There is really strong feedback that there is an unprompted link to improved adherence and that leads to the possibility to deliver a differentiated treatment experience, which is very exciting for them. I think finally they've also been very receptive to our focus on patient affordability and our attempts to create an environment that responsibly support access for patients. With regards to your first question, it really is our opportunity is really very broad because of our differentiated product profile. We do have a unique product and therefore we're having very different types of discussions. It's early for us to talk about those -- in greater detail, but it does leave us with optionality and great optionality and whether that's around Part B medical benefit or pharmacy benefit we have options in both, which are very exciting for us.
Dae Gon Ha -- SVB Leerink -- Analyst
Great. Thanks for taking that question.
Operator
Our next question comes from the line of Jessica Fye with JP Morgan. Please proceed with your question.
Jessica Fye -- J.P. Morgan -- Analyst
Hey guys, good morning. Thanks for taking my question. First on those commercial scale validation batches, do those now need the -- for stability or do you have stability data already?
Peter Wijngaard -- Chief Development Officer
I guess, you got it right. This is Peter. We do have stability data already because that would also be part of the file, both for the API, as well as for the drug product.
Jessica Fye -- J.P. Morgan -- Analyst
Okay, great. And then separately on the outcomes trial, which you mentioned was enrolling. I think you said it would complete enrollment one to two years from when it started. Can you remind me when that trial started enrolling? And then related to that, how much of the cost of the CVOT has already been incurred and how much still remains in front of the company?
Mark Timney -- Chief Executive Officer
So we announced the first patients enrolled in the line for late last year, I believe it was October. So the timeframe from the one to three years, has to be seen from that time point onwards. Chris, do you want to...
Christopher J. Visioli -- Chief Financial Officer
Yeah, on the cost, yes. As we stated, the total program would cost approximately $150 million and that would roll-out over four to five years of the trial, and we're tracking toward that. We said it on a fairly linear basis, so we're tracking within that range.
Jessica Fye -- J.P. Morgan -- Analyst
Thank you.
Operator
The next question is from the line of Tazeen Ahmed with Bank of America. Please proceed with your question.
Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst
Hi guys, good morning. Thanks for taking my questions. Just a couple on -- the comment that you made about your financials. So you said that you have enough cash to take you through to, I think, you said around the middle of 2020. Is that assumption inclusive of having to build out a sales force, that's question one. Question number two is, what are your thoughts about partnering the program at least on the ex-U.S. front? Is that your assumption that you will be partnered by the time you launch? Or do you have expectations that, we will at least start at the launch ex-U.S. Thanks.
Christopher J. Visioli -- Chief Financial Officer
Yeah, Taz, this is Chris. On the runway, it would include, we said that, we have cash to take into the second half of next year and it would include the work necessary to the pre-commercialization work necessary and R&D work necessary.
Mark Timney -- Chief Executive Officer
So that we -- as you think about sort of the build out of any commercial team that wouldn't really begin until the third quarter to them [Phonetic]. So I think you can factor that into what Chris was saying. With regards to partnering obviously, we are not -- if and when we have anything to announce, we'll obviously announce that at the appropriate time, all strategic optionality is in front of us and we're excited by those options.
Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst
And then just one follow-up, do you have a sense of how big of a commercial sales force you would need in the U.S.?
Mark Timney -- Chief Executive Officer
Yeah, it's a common question that I do get -- it's a little bit early for us at the moment. And the reason being is our extensive research continues. And as our discussions with payers and providers alike starts to build, it goes back to some of the earlier questions about how you actually would launch a product with such a differentiated profile. So little bit early for us to comment on that at this stage.
Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst
Okay, thanks.
Operator
The next question is from the line of Yasmeen Rahimi with Roth Capital. Please proceed with your question.
Yasmeen Rahimi -- Roth Capital Partners -- Analyst
Hi team, thank you for taking my questions. I have two for you. The first one is on -- for Peter. Peter can you walk me through what type of event rate data are you planning to share with your peers to really -- improve compliance to reduce event rate in the absence of CBOT results? And the second one is just a little bit detail in regards to inclisiran packaging, maybe remind us what the data [Technical Issue], does it require assumption? What is the volume of administration? So, that's it. Thank you.
Peter Wijngaard -- Chief Development Officer
Thanks, Yasmeen for your question. I'll start with the second question. So inclisiran is going to be administered as a subcutaneous injection of 1.5 ml [Phonetic], this will be in a prefilled syringe, that has a needle gauge of 27. So it's a very fine needle. Your first question, with the type of events around adherence, obviously we have started inclisiran so far, only in clinical trial setting. And as you probably know from the results we present before the adherence in clinical trials and is extremely high. We had 95% or more of the patients in a line 11, completing the 12, and receiving the four doses out to the 18 month situations of study. That rate of course will be very useful in those discussion you referred to. But ultimately it's more important to look at the market research we're doing, how the perception of the profile of inclisiran, the twice yearly administration and in -- administration by the healthcare provider. What I would translate into a real-world setting of adherence, which we do anticipate to be much higher than typical drugs that have administered much more frequently.
Yasmeen Rahimi -- Roth Capital Partners -- Analyst
And how aware are the [Indecipherable] of the lack of compliance, resulting in higher event rate?
Mark Timney -- Chief Executive Officer
Yeah, that's coming through very strongly in our research. Yasmeen it's clear that they understand the challenges with adherence many companies have tried to solve this, and many systems have tried to solve this over the periods of time. We're actually coming through the research, we're starting to see health systems and how much they're actually spending on, trying to solve this per patient. Which is -- it's been fairly dramatic for us to see that and the lengths that they're going to try to change adherence, because they know obviously it has such an impact on outcomes. So the awareness level is a very high, and it's fair to say this tremendous excitement around a product, which can be delivered by a healthcare practitioner which basically guarantees that the drug is on-board for a long period of time.
Yasmeen Rahimi -- Roth Capital Partners -- Analyst
Thank you, Tim. Keep up the good work.
Mark Timney -- Chief Executive Officer
Thank you.
Operator
Our next question is from the line of Paul Choi of Goldman Sachs. Please proceed with your question.
Paul Choi -- Goldman Sachs -- Analyst
Thank you, and good morning and thanks for taking our questions. My first question is on the regulatory side. And we're just wondering, what are the remaining steps that you have to do before filing the NDA? And then if you could lay out for us, what are your base case expectations with regard to the timing and potential topics for our potential advisory committee meeting for inclisiran given that it could be the first in class, siRNA for LDL management?
Mark Timney -- Chief Executive Officer
Thanks, Paul. I'll take those questions. So where we are with the NDA, we've always had the clinical program being the driver of timelines toward the NDA, as a non-clinical and CMC part is essentially finish earlier in the year. So dividing of the NDA, of that part is also very advanced. And what drives the overall timelines in terms of the final steps toward the NDA submission is dividing above the Phase 3 clinical data in the study reports in the integrated analysis. We are on track to have that completed by year-end and submission to the FDA by the same time. And with respect to your second question it's about questions of the outcome. As far as, while we don't anticipate to get an outcome at this point in time, we will be, we have performed a LDL-C loan program, which is unique in one sense, because of the profile of inclisiran. But on the other side, this is standard and has been for other LDL-C lowering programs and being held to the same standard. The decision is ultimately in the hands of the FDA, it would be speculative for us to make any statements on that. But what we know today, we don't anticipate, we will be having an outcome.
Paul Choi -- Goldman Sachs -- Analyst
Great. Thank you for that.
Operator
Our next question is from the line of Chris Shibutani with Cowen. Please proceed with your question.
Chris Shibutani -- Cowen and Company -- Analyst
Thanks very much. A couple of questions. In terms of thinking about potential commercial partners, I think we've had a discussion previously about how the current commercializing companies with the monoclonal antibody, might have a difficult time getting their heads around the idea of also having within their portfolio of product like yours. Is that something that you continue to feel that way and would you, for instance, think that there might be any antitrust related issues if one of the existing players considered partnering or commercializing or even owning the asset?
Mark Timney -- Chief Executive Officer
Good morning Chris, it's Mark. I'll answer that obviously, we can't speculate. I'll comment on any sort of potential partners. I think if you took us third-party view, I think you'd have to say -- the FTC at this point in time is making quite a strict approach to these types of, let's say closed collaborations. I think it's -- it would be difficult, certainly I would think in my mind, but that's I wouldn't want to speculate.
Chris Shibutani -- Cowen and Company -- Analyst
And then when you commercialize, potentially a group of patients would be those who are already taking the monoclonal antibodies. Can you remind us, I believe, number one, what studies, you are actually doing? I think there was a study that we're looking at transitioning patients.
Number two, would you think that you would be needing any particular data from a regulatory standpoint to have something in the label for that, and instruct physicians what to do. For instance, if you're on a monoclonal, would you need to do that initial sort of dose three months and then go to six months? And then finally, have you had any discussions with payers about what they think they need to know or understand in the situation where have a patient on a monoclonal antibody and we'd like to transition over. So it's really clinical studies, regulatory and sort of the commercial discussions with payers, so that potentially attractive subgroup of patients?
Mark Timney -- Chief Executive Officer
Yeah, let me start and I'll ask Peter to comment on ORION-3. So we expect the inclisiran label launch to be in combination with maximally tolerated statins in patients with ASCVD or HeFH. Frankly we see cardiovascular disease as our competitor. We see real opportunity at the top of the funnel, when you think about the number of more than 40 million people with ASCVD or FH across those major markets including the U.S. European countries, China, Japan that took all need additional LDL-C lowering, and then, not a goal. So it's clear to me there is a much larger opportunity out there, than just, if it's a small number of patients who are actually taking the monoclonal antibodies. So we expect to source patients from all lines of therapy and that's been consistent within our research as well, whether that's being with payers, healthcare providers and patients. But basically it's a any -- all who are in need of durable potent lowering of LDL-C and we're twice yearly dosing will improve adherence. Peter, would you like to talk about the studies?
Peter Wijngaard -- Chief Development Officer
Yes. Because the ORION-3 studies, the extension study of the Phase II ORION-1 study. We presented the data for the patients to maintain therapy on inclisiran early in the year at NLA. But the placebo patients that were in ORION-1 transitioned into ORION-3 first by a year of treatment, the evolocumab. And then they are, have been switched to inclisiran in two different ways by two different transitions mortality and concomitant administration of the last dose of a evolocumab combined with inclisiran or by an interval of two to three weeks, which is sort of typical dosing interval for the antibodies. That data will be forthcoming, and we will of course have information from that study, that will provide guidance on how to switch from a monoclonal antibody-2 inclisiran. And obviously, at the appropriate time, we will try to have the dose reflected in the label, whether that will be possible will depend on the suitability of the data that we have and the FDA's opinion on that, as well as other activators in the world. But we certainly intend to have that ultimately in the label.
Chris Shibutani -- Cowen and Company -- Analyst
Great. And then last quick detail, the previous wording in the second quarter with cash, well into the second half. This quarter you would say, into the second half, am I being too specific about -- was that a deliberate change of wording or...?
Mark Timney -- Chief Executive Officer
No, not deliberate. Yeah, you've been too specific, correct.
Chris Shibutani -- Cowen and Company -- Analyst
Looking for Q&A. Thank you. Thanks, Mark.
Mark Timney -- Chief Executive Officer
Good question. Good question.
Operator
Our next question is from the line of Mayank Mamtani with B. Riley. Please proceed with your question.
Mayank Mamtani -- B. Riley FBR -- Analyst
Good morning. Thanks for taking my question and congrats on the flawless execution to report there. Interesting to hear Amgen's management team commentary last evening on inclisiran. Mark wondering if you could comment, what you or even Diane might be hearing from your industry peers or should I say, some of them ex-colleagues in case you've had a chance to and formally review inclisiran's overall profile? Or maybe you run into some of them might be AHA, just curious from the industry side folks committed to cardiovascular what you're hearing there?
Mark Timney -- Chief Executive Officer
Thanks for the question Mayank. And obviously I can't comment on any strategic discussions or any speculation. I will say that it's well known and we saw this that AHA, there is tremendous excitement around inclisiran. And I think that's across all stakeholder groups. It's a well known product. I think the data speak for themselves and that's only built around the excitement of the product profile that is now coming to bear. So very exciting and I don't think that's changed.
Mayank Mamtani -- B. Riley FBR -- Analyst
Okay. Great. If I could do a follow-up, so now you have all the data in-house and obviously you talked about your pre-commercial plans and you think about the different patient profiles that any cholesterol lowering company considers as part of the large plan, maybe could you comment on what that ideal patient looks like for inclisiran until we have that longer-term safety exposure and of course the outcomes data, just across the different patient profiles?
Mark Timney -- Chief Executive Officer
Yeah, it's remarkably consistent with what I said. I mean, we do expect, that the label to have at launch to be with maximally tolerated statins in patients with ASCVD or HeFH. And really it is those patients who're struggling to get to go though secondary prevention high-risk patients that will really form, that the basis of the patient group that will be, what we're really benefit from inclisiran at launch. Obviously, we would have a full lifecycle management plan that will expand that patient population of the time as we learn more about it. We don't, even though we will not have outcomes, cardiovascular outcomes at launch. We don't expect that to be a barrier for any of our major stakeholder groups. The question that whenever I post this question and whether we post in an research what consistently comes back to us is, did anybody wait for outcomes when rosuvastatin launched. And the clear answer is no. PCSK9 is a well-validated target. We've got outstanding data over a long period of time. We've done some of the longest LDL-C studies in the history of cardiovascular medicine and that will support a very strong profile and it will support a strong launch.
Mayank Mamtani -- B. Riley FBR -- Analyst
Excellent. And if I can squeeze one in for Peter. Peter any color you could provide on emerging cardiovascular targets such as ANGPTL3 which according to some, again, early, but it could be a competitive threat to the PCSK9 class as a whole, any thoughts there?
Peter Wijngaard -- Chief Development Officer
Yes, because they are early programs right now, so it's hard to predict what exactly the data set will be by the end of Phase 3. But the only thing I would add to that is, that most of those opportunities do not touch the patient populations at large, that we are targeting who has ASCVD and FH with patients -- not a target goal. Most of those opportunities we are talking about either product specific sub-populations like the FH or the homozygous FH, all patients with elevated triglycerides, it's kind of come secondary to LDL-C.
Mayank Mamtani -- B. Riley FBR -- Analyst
Great. Thanks for taking my question, Tim.
Operator
The next question is from the line of Akash Tiwari with Wolfe Research. Please proceed with your question.
Akash Tiwari -- Wolfe Research -- Analyst
Hey, thanks so much. So maybe just going a bit on the Phase 3s that are going to get the full data. Can you compare and contrast like the baseline severity in CVD, burden of the ORION-9 population versus ORION-11. And have you seen any change in the net reduction of LDL-C patients baseline LDL-C increases. And it also looks like you're mentioning that Japanese and China market a bit more in your prepared comments. Is it fair to assume that those are markets you'd like to look to partner and how would you kind of characterize the size of the commercial opportunity in those markets versus let's say in U.S. Thanks a lot.
Mark Timney -- Chief Executive Officer
Peter, do you want to take the first part?
Peter Wijngaard -- Chief Development Officer
Yes, obviously I can't comment on specific data points from 9 and 10, as they will be presented at AHA on Saturday for ORION-10, and on Monday for ORION-9. But I can't speak to the difference in the patient populations of those trials. So ORION-11 was a European and South African study in ASCVD patients and ASCVD risk equivalents. We should have the same risk of cardiovascular events and need for LDL-C allowing. The ratio between the two populations in ORION-11 was approximately 85% to 15% of ASCVD and risk equivalent. If I intend -- it's a U.S. only study and only included ASCVD, so it's highly similar than ORION 11. But there were some fine difference in the exact composition of the patient population, and then of course the geography where it was discussed -- where it was conducted. And ORION-9 on the other hand is a dedicated study and heterozygous FH patients that was conducted globally.
Now heterozygous FH patient is an early manifestation of ASCVD, so patients are at risk at an earlier stage in life and largely in totality, considered to have a high risk of ASCVD because of that early manifestation, and it's all driven by the genetic background of the mutations that they carry, that causes them to have the disease of FH. So in that context, though at a higher risk over the life, of course whether they are specifically different in the risk populations in this study, we will show you that data when we -- when we get to AHA.
Mark Timney -- Chief Executive Officer
And let me just touch on the question around Japan and China, we are receiving significant interest in the profile of inclisiran within those countries whether that's with the payers or with the key opinion leaders. As you would well know, there is significant ASCVD in those regions of the world. And therefore it's incumbent on us, to ensure that there is a robust plan for how those regions would actually be accessed. We've said, and we continue to believe that if we are to do anything within Japan, we would do that with a partner and we have regulatory pathway to what type of bridging studies would need to become inducted in both markets.
Akash Tiwari -- Wolfe Research -- Analyst
Great. Thanks so much.
Operator
Next question comes from the line of Madhu Kumar with Robert W. Baird. Please proceed with your question.
Madhu Kumar -- Robert W. Baird -- Analyst
Yeah. So, thanks for taking our questions. So thinking about the MACE observation that you made guys with ORION-11 and ESC. If there weren't, I'm not saying whether there are not in the ORION-10 dataset at AHA, would that be similarly presented in the presentation or how should we think about kind of MACE observations in the U.S. ASCVD trial?
Mark Timney -- Chief Executive Officer
Thanks Madhu, ORION-9, 10, 11 for that matter, were designed with the exact same concept of the protocol. So the endpoints we collected in 11 are the same endpoints we collected in 10 and 9. 10 is about the same size as ORION-11, so yes, we will be able to provide that data in the upcoming presentations. Nine is a much smaller study, so I would not read too much in that particular endpoint for a ORION-9.
Madhu Kumar -- Robert W. Baird -- Analyst
That's it for me. Thanks very much guys.
Operator
The next question is from the line of Jay Olson with Oppenheimer. Please proceed with your questions.
Jay Olson -- Oppenheimer -- Analyst
How are you guys? Thanks for taking my questions. I wanted to ask about on your discussion with payers that you commented on earlier. I was wondering if you're considering any innovative approaches with payers such as performance-based reimbursement where payers may pay more or less depending on patients getting to goal. And then as a follow-up just wanted to circle back on some of the comments you made about Europe where I think you mentioned there all options are still on the table. I was wondering if that meant, you are in fact considering building a commercial infrastructure in Europe? Thank you.
Mark Timney -- Chief Executive Officer
Hi, Jay. Thanks for the questions. With regards to the payers, as I said, the research is very clear for us and very excited about the differentiated profile. It's fair to say for us all options is still on the table, it's very early within our research. As I say is that the data become available not only our outreach but inbound questions around inclisiran, and how best to create access, leading us to really think very carefully about that. And hence to my earlier comment that really has an impact on how we think about commercial planning and infrastructure going forward. That's not dissimilar to how we see it within Europe is a differentiated profile, you have an opportunity to do something very different, and all strategic options are still on the table for us.
Jay Olson -- Oppenheimer -- Analyst
Great. Thank you.
Operator
Our next question is from the line of Biren Amin with Jefferies. Please proceed with your question.
Biren Amin -- Jefferies -- Analyst
Yeah, hi guys. Thanks for taking my questions. Mark, I want to get your views on what you think continues to ail the PCSK9 class. Historically the criticism has been that the class is priced too high at $10,000 to $13,000. But now that the prices cut to less than $6,000. We still continue to see sales growth being flat yesterday, last night, for example, Amgen reported Repatha, it's about $80 million to $85 million, which is basically where they've been stuck at the last few quarters. So I just wanted to get your impression on what you think triggers the class and causes the trajectory that we've been expecting?
Mark Timney -- Chief Executive Officer
Yeah, thanks. Thanks for the question. I think it's, I think the issues -- around pricing a well known and not for me to comment on, I think that what was a real positive and certainly what we see, and our research in multiples is that you did here on the call that there is increasing volume certainly coming from Repatha and Amgen. And I think that only speaks to the opportunity that we certainly see in the research. I still keep anchoring back to the size of the treatment population that could benefit from a product light inclisiran, which is as I talked about in these major markets is around about 40 million patients. And therefore for us the opportunity is much larger.
I think in order to take advantage of that opportunity, you have to do a number of things, you have to be able to clearly understand the research and find and define that clear patient population that ASCVD secondary prevention population who would really benefit of getting additional LDL-C lowering. But also the patient populations, who just struggle with adherence and that just increases the risk, especially around cumulative exposure to LDL-C. No other product can do the types of studies that we've been able to do around cumulative exposure. And that for me is it's a very exciting possibility. So as I do think about it, I think you've -- it's we obviously watch, we watch closely. It's not a competitive set, that is really where we would anchor ourselves because we think out product profile is so differentiated and much more suitable to a chronic indication.
Biren Amin -- Jefferies -- Analyst
Got it. And then maybe a couple of follow-ups. I think the company has previously mentioned that you plan to target not just cardiologists, but also general practitioners. So I guess my question is, what percentage of eligible patients are treated by GPs compared to cardios? And what types of sales force would be necessary to cover GPs?
Mark Timney -- Chief Executive Officer
Yeah, it's a great question. Let me because I don't to want to get too much into what would be a potential commercial strategy here. But it's fair to say that as you think about the management of our a cardiovascular patient -- the cardiovascular patient is managed within the GP setting. There is no doubt the cardiologists have a clear and very important role to play. But that day-to-day management is clearly gone through the GP side. So there is a real blend here. And I think both stakeholder groups are very, very important.
Biren Amin -- Jefferies -- Analyst
And then I guess on the question on the sales force size that you would need to cover the GPs?
Mark Timney -- Chief Executive Officer
Yeah, that's still, we're still looking at that. It's very early for us to comment. I think in some way, shape or form we will be engaging with that important stakeholder group, but how and what that looks like it's still yet to be determined.
Biren Amin -- Jefferies -- Analyst
Great. Thank you.
Operator
The next question is from the line of Joel Beatty with Citi. Please proceed with your question.
Joel Beatty -- Citigroup -- Analyst
Hi, thanks for taking the questions. But can you go into a lot more detail on which types of healthcare providers are most likely to be administering inclisiran? And then also what types of settings administration is most likely to return?
Mark Timney -- Chief Executive Officer
Thanks for the question, Joel. We've got tremendous optionality around this. And again, it's very much part of our current work and current thinking. Obviously a healthcare practitioner comes in many, many guidance. I think the setting and our focus is making resetting the one which is most appropriate. We're obviously we have the great benefit that substantial amount of the patients are seeing their healthcare provider at least twice a year, so it's very consistent with the dosing schedule. But again, it comes back to, how do we make this as simple and is accessible as possible for the patients to get it and that's part of our planning.
Joel Beatty -- Citigroup -- Analyst
Thanks, sir. And one follow-up, could you talk about the potential timing of publications for the ORION Phase 3 data sets. And if that could come at the same time as AHA?
Mark Timney -- Chief Executive Officer
We are working together with the principal investigators in the steering committee to get the data of all the three Phase III studies published as soon as we possibly can.
Joel Beatty -- Citigroup -- Analyst
Okay. Thank you.
Operator
Thank you. We have reached the end of our question-and-answer session. I will turn the call over to management for closing remarks.
Mark Timney -- Chief Executive Officer
Okay. Thank you, Rob, and thank you all for your questions. So, we successfully completed inclisiran's pivotal Phase III trials and presented exceptional safety and efficacy data for the ORION-11 study at the ESC Conference in Paris. And we look forward to presenting ORION-9 and 10 studies at the AHA conference in November. Inclisiran's highly differentiated profile and 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 extension into 2035, sets the stage for significant shareholder value creation.
And with that, I'll close the call and wish you all a very good day. Thank you.
Operator
[Operator Closing Remarks]
Duration: 54 minutes
Call participants:
Krishna Gorti -- Vice President of Investor Relations
Mark Timney -- Chief Executive Officer
Christopher J. 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
Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst
Yasmeen Rahimi -- Roth Capital Partners -- Analyst
Paul Choi -- Goldman Sachs -- Analyst
Chris Shibutani -- Cowen and Company -- Analyst
Mayank Mamtani -- B. Riley FBR -- Analyst
Akash Tiwari -- Wolfe Research -- Analyst
Madhu Kumar -- Robert W. Baird -- Analyst
Jay Olson -- Oppenheimer -- Analyst
Biren Amin -- Jefferies -- Analyst
Joel Beatty -- Citigroup -- Analyst
