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Medicines Co (MDCO)
Q1 2019 Earnings Call
April 25, 2019, 8:30 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Greetings, and welcome to The Medicines Company's First Quarter 2019 Earnings Call Webcast. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce Krishna Gorti, Vice President of Investor Relations. Thank you, Mr. Gorti. You may begin.
Krishna Gorti -- Vice President of Investor Relations
Thank you, Sherri. Good morning to everyone, and welcome to The Medicines Company's First 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 first 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 mornings 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 the 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, Director
Thank you, Krishna. Good morning, everyone, and thank you for joining us today. Before I begin a review of the quarter, I'd just like to remind us all why we're here. Cardiovascular disease remains the world's #1 cause of death, accounting for 17.3 million deaths a year globally and 1 in every 3 deaths in the United States. Atherosclerotic cardiovascular disease, or ASCVD, is the leading cause of CVD morbidity and death. Cumulative exposure to LDL cholesterol, also known as the LDL-C or bad cholesterol, is its most readily modifiable risk factor.
Despite the widespread availability and use of proven LDL-lowering therapies, notably statins, many people with ASCVD are not meeting treatment goals primarily due to lack of adherence. At The Medicines Company, we believe there are 2 critical unmet needs. First, additional LDL-C lowering is needed so that ASCVD patients consistently reach their goal and avoid a cardiovascular event. Second, underlying this first need is poor patient adherence to LDL-C lowering therapy. Leading authorities in cardiovascular medicine continue to point to these same unmet needs. Earlier this year, the American Heart Association Call to Action report cited large missed opportunities at every step in the prevention and treatment of cardiovascular disease. Nearly 2/3 of patients are not adhering to statins after 1 year. 20% to 40% of heart attacks occur on undiagnosed cardiovascular disease patients with 30% of heart attacks in undiagnosed high cholesterol patients.
And earlier this month, a study in the journal Heart found that half of patients prescribed statins in primary care failed to reach healthy cholesterol levels after 2 years of treatment with these drugs. In that paper, research has highlighted the need for personalized medicine and improved adherence to tackle high cholesterol and lower the significantly increased risks of future heart disease and stroke. Our company's purpose is to address this enormous unmet need and to hold the deadly progression of atherosclerosis and the cardiovascular risk created by high levels of LDL-C.
We aim to achieve this purpose by developing inclisiran. Inclisiran is the first cholesterol-lowering therapy in the small interfering RNA class. It provides significantly -- clinically significant LDL-C reductions greater than 50% on top of optimal background lipid-lowering therapy and has the potential to deliver potent, durable and consistent effect through a 6-month dosing interval. Its twice-a-year dosing regimen 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 these patients.
We believe inclisiran has the potential to fundamentally change the treatment of ASCVD based on the durable and consistent efficacy with minimal variability around the LDL-C lowering the potential for significant cardiovascular outcome benefit with inclisiran is extremely high. It 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 turning to the clinical development program. We continued our strong momentum and execution during the first quarter. We successfully advanced inclisiran in the pivotal ORION Phase III trials during this quarter. Last week, the independent data monitoring committee reviewed unblinded safety and efficacy data from the Phase III trials for the sixth time as planned and recommended continuation of the trials without modification of the protocols.
At the time of the sixth IDMC review, substantially all randomized patients had been treated with 3 doses and completed a follow-up visit 60 days after the third dose of study medication, and more than 1,600 subjects had received the fourth dose of the drug. To date, more than 3,000 patient years of inclisiran safety data have been accumulated in the ORION program. Our ongoing review of blinded data to date from the Phase III trials as well as data from the ORION-1 Phase II extension trial show no material safety issues, and data there that are at least as favorable as those generated and published from the ORION-1 Phase II trial. While the independent data monitoring committee sets its own schedule, we do anticipate further reviews in 2019 as we continue to accrue inclisiran safety data at the rate of 5 patient years today.
The inclisiran development program is the industry's largest small interfering RNA program targeting atherosclerotic cardiovascular disease. Inclisiran has to be -- has the potential to be the leader in lowering LDL-C in high-risk ASCVD patients. It is moving quickly through Phase III trials, and we're encouraged by the overall clinical safety profile and expect Phase III data readouts in the third quarter. In parallel, pre commercialization work is ongoing and affirms the highly competitive profile of inclisiran.
As our clinical development program advances, so too does our ability to bring forward new data and analyses for presentation and publication. Enrollment of patients into the ORION-4 cardiovascular outcomes trial is ongoing and remains on track. As a reminder, we plan to complete enrollment within 1 to 2 years. ORION-8 is an open label long-term extension study where patients completing ORION-9, ORION-10 and 11 will receive inclisiran for 3 years to evaluate the efficacy, safety and tolerability of long-term dosing of inclisiran. The first patients who have completed the follow-up in the Phase III trials have started the ORION-8 Phase III long-term extension study.
We will present interim results on long-term safety and efficacy of inclisiran from the ongoing ORION-3 study during a late-breaking clinical trial session at the National Lipid Association scientific sessions in Miami, Florida on May 18, 2019. Subjects who completed the ORION 1 Phase II study and met all inclusion and exclusion criteria enrolled into 2 groups into the ORION-3 study. The ORION-3 primary endpoint is mean percent change in LDL-C from the ORION-1 baseline value measured at the Day 210 of the ORION-3 study in group one only.
The group one included subjects previously treated with any inclisiran dose in ORION-1, which is a total of 290 subjects were enrolled. These subjects received twice-a-year injections of 300 milligrams of inclisiran sodium. The interim analysis that will be reported at NLA will include safety and efficacy data of inclisiran from group one only. The group two included subjects previously treated with placebo in ORION-1, a total of 92 subjects were enrolled. These subjects received 1 year of treatment with evolocumab and followed by 3 years of treatment with 300 milligrams of inclisiran sodium, given on Day 360 and 450 and every 6 months thereafter. The group two safety and efficacy of switching from evolocumab to inclisiran will be assessed in an exploratory manner. Follow-up is ongoing and, therefore, is not part of the interim analysis that will be presented at the NLA.
ORION-7 is a Phase I single-dose, open label trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of inclisiran in participants with mild, moderate and severe renal impairment compared to participants with normal renal function. ORION-2 is a Phase II pilot study to assess the safety, tolerability and efficacy of inclisiran in participants with homozygous familial hypercholesterolemia. On May 27, during the 87th European Atherosclerosis Society Congress in Maastricht, Netherlands, the company will present a combined analysis of safety and efficacy data in renal-impaired patients from ORION-1 and ORION-7 during an oral abstract session. Data on homozygous familial hypercholesterolemia patients from ORION-2 will also be presented during a late-breaking abstract session.
So the opportunity to help people simply and dramatically lower LDL-C and live healthier lives and the magnitude of the unmet need and health challenge speaks to the potential market opportunity for inclisiran. The numbers for high-risk undertreated patients with ASCVD and FH requiring lipid-lowering therapies is staggering. In the U.S. alone, we believe nearly 12.7 million patients could benefit from inclisiran and on a global basis, it could be nearly double. Our ongoing robust pre-commercialization work has further increased our excitement about inclisiran's profile and potential. We're 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 Visioli, who will cover our financial results for the first quarter. Chris?
Chris Visioli -- Chief Financial Officer
Thank you, Mark, and good morning, everyone. During the first quarter of 2019, we continue to make significant progress in advancing inclisiran through clinical development, key manufacturing activities and preparation for NDA MAA filing. Research and development expenses were $27 million, including $700,000 in stock-based compensation expense in the first quarter of 2019 compared to $40.4 million, including $1 million in stock-based compensation expense for the same period in 2018.
R&D expenses for the quarter included continued cost associated with the pivotal ORION Phase III clinical programs, inclisiran manufacturing development work, the start-up activities and enrollment in the ORION-4 CVOT program, the start-up in transition of patients from the pivotal programs into the ORION-8 extension study and head count associated with R&D.
SG&A expense was $17 million including $3.8 million in stock-based compensation expense in the first quarter of 2019 compared to $29 million, including $3.4 million in stock-based compensation expense for the same period in 2018. On an adjusted basis, SG&A for the quarter was $13.1 million, down 27% from adjusted SG&A during the first quarter of 2018 on a comparable continuing operations basis.
Our cash and cash equivalents at the end of the first quarter was 20 -- was $199.7 million. We continue to anticipate that our existing cash will enable us to fund operating expenses into 2020, allowing for data readout of pivotal Phase III programs, continuation of the Phase II and III extension studies, manufacturing validation, pre-commercial planning work and filing of our NDA and MAA to their respective agencies. We look forward to the pivotal Phase III data readout in Q3.
With that, I'll turn the call back over to Mark. Mark?
Mark Timney -- Chief Executive Officer, Director
Thanks, Chris. So in summary, 2019 is a momentous year for inclisiran, which is moving quickly through Phase III trials. We're encouraged by the overall clinical safety profile and expect Phase III data to read out in the third quarter. In parallel, pre-commercialization work is ongoing and affirms the highly competitive profile of the product. 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.
The Medicines Company has full unincumbered commercial rights to inclisiran in all markets and market exclusivity to mid-2034 with expected extension into 2035. We continue to anticipate our existing cash will enable us to fund operating expenses into 2020, and 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, I want to thank you for your listening, turn the call back over to the operator so we can take some questions.
Questions and Answers:
Operator
(Operator Instructions) Our first question is from Paul Choi with Goldman Sachs. Please proceed.
Paul Choi -- Goldman Sachs -- Analyst
Thank you. Good morning and thanks for taking our question. I had a maybe a 2-part question on the ORION-8 trial. And I guess the first part is how do you think about what potential, either efficacy or safety claims, do you think you can gather from the extension data? And how do you think about that potentially being integrated into the label in the future ahead of the cardiovascular outcomes data. And secondly, in the interim ahead of the CVOT data, how do you think about incorporating this data from a promotional or commercial perspective as you market inclisiran going forward? Thanks
Mark Timney -- Chief Executive Officer, Director
Thanks for your question, Paul. As we've got Peter here, and I'll ask him to take that question.
Peter Wijngaard -- Chief Development Officer
Thanks, Mark. So ORION-8 just started. As patients finished ORION Phase III program individual studies, we will be collecting long-term safety and efficacy data for ORION-8 with an overall follow of up to 3 years in addition to the duration that were in the Phase III program. That long-term efficacy and safety data kind of will ultimately be used later on in potential language in the label in the clinical trial sections, but it's a bit too early to speculate what exactly that would lead to in terms of claims at this point in time.
Mark Timney -- Chief Executive Officer, Director
And I think, Paul, to the second part, it's a little bit too early to understand what those data would look like and how we would build it into any labeling going forward. Obviously, as we collect those type of data, that will be important to us. We do believe our label launch will allow significant opportunity for the patients who need to get access to this product.
Paul Choi -- Goldman Sachs -- Analyst
Great. Thanks for taking our questions.
Operator
Our next question is from Tazeen Ahmad with Bank of America. Please proceed.
Tazeen Ahmad -- Bank of America -- Analyst
Hi good morning. Thanks for taking my questions. Maybe I could ask a couple on your pre-commercial efforts under way. Assuming that the data is positive later this year, how are you envisioning timelines for example to apply and for example what size sales force you think you would need for your targeted patient population? And when do you foresee starting to hire all those people in.
Mark Timney -- Chief Executive Officer, Director
Thanks for the question, Tazeen. It's very early for us still with our commercialization activities, and it's difficult for us to say, to talk about current sizing. We are undertaking a number of pre-commercialization activities that would be important to enabling a successful launch with the same level of robustness that a large pharmaceutical company would exercise. So with that, that allows us to keep optionality on the table in an ever-changing landscape, but it is very early for us to be thinking about sizing just yet.
Operator
Our next question is from Jessica Fye with JPMorgan. Please proceed.
Jessica Macomber Fye -- JP Morgan Chase & Co -- Analyst
Great. Good morning guys. Thanks for taking the questions. Maybe just on the ORION-3 update coming up at the Lipid meeting. It seems like you could have provided this interim data sort of any time, so why now?
Peter Wijngaard -- Chief Development Officer
Thank you, Jessica, for the questions. This is Peter. We provided the data for the NDA actually as we have past the time point of follow-up that allows to present data from efficacy and safety from the group one patients. And these were the patients that transitioned over from ORION-1 had received any dose of inclisiran in the ORION-1 Phase II study and continue to receive inclisiran in ORION-3 on the 6 monthly dosing schedule. The primary endpoint for that group and the [final end] of the study was day 210 of ORION-3, and we are now beyond that time point for all patients.
Jessica Macomber Fye -- JP Morgan Chase & Co -- Analyst
Great. And how many patients will we see from group one?
Peter Wijngaard -- Chief Development Officer
290 were and we'll move into the ORION-3 in group one.
Jessica Macomber Fye -- JP Morgan Chase & Co -- Analyst
Great. And with the sixth DSMB update now cleared, should we expect anymore DSMB updates prior to the full Phase III results.
Peter Wijngaard -- Chief Development Officer
As we said in the script, the DSMB set their own schedules for subsequent meetings, but they happen on a regular frequency in the past 6 events, and we do expect that further DSMB reviews, they'll be conducted before completion of the overall Phase III program.
Jessica Macomber Fye -- JP Morgan Chase & Co -- Analyst
Thank you.
Operator
Our next question is from Umer Raffat with Evercore ISI. Please proceed.
Umer Raffat -- Evercore ISI -- Analyst
Hi. Thanks so much for taking my question. I just wanted to really zoom in on safety and mainly just everything you've said and everything you know to date on safety, and I want to touch on 4 different things within that. First, you've said several times now in the last few months emerging data is at least as favorable. Can you sort of describe for us what is it that you're seeing, what exactly is the genesis behind that specific sentence, number one? Number two, I noticed you've also said no reports of study-related LFTs. Is that still consistent as of latest DSMB looks unblinded data. Can you confirm that? Third, you've also mentioned no material safety to date. Can you just comment on what you're referring to, which isn't material, just injection site reactions. And finally, if you could and it's really helpful for everyone, if you could just recap for us those patients from Phase II, which had abnormal preteen kinase increases and what was the fate there and was drug related or not.
Mark Timney -- Chief Executive Officer, Director
Thanks, Umer. We'll -- I'll pass those questions straight to Peter because he lives this every day.
Peter Wijngaard -- Chief Development Officer
Yes. And I understand your questions and why you're asking them, but we can't really specifically comment at this point. And I don't have any specific data points as with the value to present the ORION-3 data at the end of a meeting so. It would be inappropriate to make specific comments at this point in time, but we invite you to listen to that presentations on May 18 when that happens. And overall, our statement on the blinded and unblinded maybe of the safety data from the Phase III trial as well as the data from the ORION Phase II extension studies have shown no material safety issues and the data are at least as favorable as those generated and published ORION-1 Phase II trial. That's all we can say at this point in time with respect to your last question on the CK elevations in ORION-1. We had few and all of them are not related to the drug as we have reported to you before.
Operator
Our next question is from Chris Shibutani with Cowen and Company.
Pam Barendt -- Cowen and Company. -- Analyst
Hi. Thanks so much for taking my question This is Pam Barendt on for Chris Shibutani. Can you help us understand your current thinking about whether you would present ORION-9, 10 and 11 together? Or if you would present them in rapid succession or metered out over time. Your current thoughts, please?
Mark Timney -- Chief Executive Officer, Director
Peter?
Peter Wijngaard -- Chief Development Officer
Yes. Thank you, Pam, I think your name was. As we said before, the studies finished enrollment in about in a 6-week sequence earlier in 2018. ORION-11 finished enrollment first on January 25, followed by ORION-9 on February 20 and ORION-10 on March 8. So the 8-month follow-up period following pretty much the same sequence. And what we have said before, we anticipate to have data, Phase III data readout in Q3, and we will provide top line results as soon as we have them in the sequence that they come to us, and we will present the results in detail at upcoming major cardiovascular conferences later in the year, but we haven't provided any more specific detail so we can't do so until we see the data.
Pam Barendt -- Cowen and Company. -- Analyst
Got it. And if I can add a follow-up question. Can you also let us know your current thoughts on cash burn and runway.
Mark Timney -- Chief Executive Officer, Director
Chris?
Chris Visioli -- Chief Financial Officer
Yes. No. Thanks. As we said, we believe we anticipate that our cash will take us into 2020 and will provide runway to get through all the key data inflection points and the filing of the NDA MAA.
Operator
Our next question is from Yasmeen Rahimi with Roth Capital Partners. Please proceed.
Yasmeen Rahimmi -- Roth Capital Partners -- Analyst
Hey. Thank you for taking my question Two, one on safety, one on commercial. Let's begin with the safety one. So everyone has a type of focus, obviously, on liver enzyme elevation. So can you tell me what in your view or at least from physician's view is a no big deal rate that we should extract [from ALCs]? And how close are do cardiologists pay attention liver enzymes in the real world? And then I have a follow-up in regards to commercial.
Peter Wijngaard -- Chief Development Officer
On the specific safety data points as we have them today, as I said before, we cannot really comment on until we presented data at the scientific sessions for ORION-3 at NLA and for the phase III studies later in the year. I think with respect to your questions on how cardiologists see liver function and liver safety in general, they are, of course, familiar with issues of LFT elevations with statins. They happen in about 1% to 3% on average in the population that we are treating here and then dealing with them as appropriately when those situations happens, and there will be the same for the trials we're doing in the Phase III with inclisiran as well as later in life once we get approved them on the market.
Yasmeen Rahimmi -- Roth Capital Partners -- Analyst
And then maybe the commercial question is I, mean, We've spoken a great deal about lack of compliance and [in a sense] a differentiation in the market place. Have you done any market analysis work where you looked at? What is the percentage of patients that are committed to actually see their cardiologist every 6 months? And what percentage, I guess, miss it? And that does those rates play into pricing and pair question.
Mark Timney -- Chief Executive Officer, Director
It's Mark. Yes, we do have some analysis on the high-risk patients that would be the target for inclisiran and their visit schedule with either a cardiologist or with a primary care physician. It is about 93% of those patients will see their physician every 6 months, which is obviously totally in line with the value proposition of inclisiran. So that's very exciting for us.
Yasmeen Rahimmi -- Roth Capital Partners -- Analyst
Thank you Mark. That's very useful information. I'll jump back in the queue.
Operator
Our next question is from Joel Beatty with Citi. Please proceed
Joel Beatty -- Citi -- Analyst
Thanks for taking the questions. The first one is on the pre-commercialization work you're doing. Could you characterize a little bit more about what you're doing and how that information could help give you confidence on how inclisiran could change the launch curve that we've been seeing from the PCSK9 antibodies.
Mark Timney -- Chief Executive Officer, Director
Thanks for the question. It's -- as I said, we're -- the pre-commercialization work is we're obviously just over 18 months, a little bit longer out from launch, so it's still very early. But we are doing work that is as robust as what you would see for a large pharma. So typical type of research that's under way whether it's demand research, co-claims type research, you could also look at payer research, which is going to be an integral part of this. We do believe and we're starting to see in early research that inclisiran's differentiated profile is very attractive to not only prescribers but also to patients. Beyond that, it is too early. And for competitive reasons, I would not like to say too much more, but be sure as we -- as this research progresses and when the timing is right, we'll share more of those results.
Joel Beatty -- Citi -- Analyst
And then one follow-up question on the outcomes trial. In the past months, the company has talked about how the company believes it can do the outcomes trial for much cheaper than is typical for these trials. Now that enrollment has been under way for several months, could you talk about those costs, and how they're tracking compared to your original projections?
Mark Timney -- Chief Executive Officer, Director
Yes. No. Good question, Joel. Tracking spot-on original projections, we have long term contracts with CROs in the academic institutions that are basically time-based payments so unless there were any substantial change to the protocol or anything we wouldn't expect any straying from our original projections where we said we could do the outcomes trial for up to $150 million total.
Joel Beatty -- Citi -- Analyst
Great, thank you.
Operator
Our next question is from Joseph Schwartz with SVB Leerink. Please proceed.
Dae Gon -- SVB Leerink -- Analyst
Hi good morning. Thanks for taking my questions. This is Dae Gon dialing in for Joe. So one question and then a follow-up. So I know it's still early days, but Mark, I guess if we look back into how you went and Repatha and their decision to lower their list prices we should be seeing a little bit of that impact since, I believe, it probably went into effect in March. So can you maybe talk about some early market dynamics since that list price has come into effect and how that gives you more confidence about the launch's trajectory for inclisiran. And then second question is on ORION-7, the renal impairment study. I do recall at the Analyst Day last year, you presented some PK/PD data. So maybe remind us what you anticipate to present. Is their material -- new information added on top of what was disclosed last year? Thanks
Mark Timney -- Chief Executive Officer, Director
Thanks, Dae Gon. I'll take the first one. I'll hand over ORION-7 to Peter. Yes, obviously, there are a lot of dynamics within the market space that we are tracking, we're watching very carefully. Obviously, for us it's still a fair way out for launch so we would expect to see further change. We have seen an uptick in new patients and also switching. And obviously, I'm sure you'll be able to get those detailed data from the relevant companies. What I will say is you will see and we expect probably until year-end, you're going to continue to see those dynamics unfolding as the contracts unwind for the various companies, but it's good to see where we're still seeing very strong, I would say, demand and recognition for PCSK9 as a target and recognition that the efficacy and safety of products that target PCSK9 is very strong from customers. So I expect that to continue and we expect that certainly with what we see in the early days that scripts will continue to improve as access improves. ORION-7?
Peter Wijngaard -- Chief Development Officer
Yes, ORION-7 and the combined analysis of ORION-1 and 7. What we will present at EAS is from ORION-7 the longer follow-up. That study's now fully completed earlier last year when we gave an update on the interim, the study was still ongoing. The longer follow-up is out to 6 months after the single dose I was giving in that study. And secondly, this is combined now with the analysis of patients with various degrees of renal impairment from the ORION-1 study, so we will provide more details on the efficacy and safety in the subgroups from the 2 studies combined.
Dae Gon -- SVB Leerink -- Analyst
Great, thanks for that.
Operator
Our next question is from Madhu Kumar with Robert W. Baird. Please proceed.
Madhu Kumar -- Robert W. Baird -- Analyst
Yes, thanks for taking my questions. So my questions are mostly around operating and expense dynamics. So how much do you think the kind of current operating and expense both on R&D and SG&A are likely to be stable over the year, particularly SG&A in the context of potential success for ORION-9 to 11, the kind of regulatory and commercialization ramp-up that would follow from that and on R&D with the kind of expansion of ORION-4 as you [recruit] that trial up.
Chris Visioli -- Chief Financial Officer
Yes. No. We provide a little bit of color. Obviously, we didn't give detailed R&D and SG&A guidance for the year. I think what we said on the last call is as we track toward the year and as we start to read out data, we'd expect modest increases on the SG&A front. On the R&D front, we would expect to continue marching toward the plans that we laid out in the beginning of last year and probably fairly consistent numbers with what you're seeing through the first quarter. I think that answers your questions.
Mark Timney -- Chief Executive Officer, Director
I think at the end of the day, Madhu, we're still very much focused on value creation fit for shareholders so there's a very -- with our focus on execution, we're also very tightly watching our finances. So anything that we're doing in terms of commercial spend is being carefully selected but is being put into best use.
Madhu Kumar -- Robert W. Baird -- Analyst
Great. And then on the ORION-3 data, so you mentioned already you're presenting group one, not group two. Is there any expectation to present group two either before ORION-9 to 11 or kind of closely after ORION-9 to 11 to kind of sort of add in the switch data for the kind of the Repatha-pretreated patients. Is there any reasons the time line works that data could come?
Mark Timney -- Chief Executive Officer, Director
We haven't given any specific guidance on that model. As we described ORION-3, it's started to when patients were finishing ORION-1, which is, to remind you, was up to 1 year of follow-up. And after they started ORION-1, there was actually a little period of a gap in between before they could start ORION-3 mainly for (inaudible) reasons, getting the sites approved and the protocol approved in the various countries, in the various sites. So in group two where they get 1 year of evolocumab and then switch over to inclisiran to receive inclisiran in the Phase III dosing regimen on the first day with the booster dose at day 90 and then every 6 months thereafter. That follow-up is still ongoing, and we can only present the data when the appropriate follow-up is complete. The overall study duration is 4 years and is expected to complete in 2022. So to be specific on your question whether we can expect data prior to Phase III, I think the answer on that one is a clear no.
Madhu Kumar -- Robert W. Baird -- Analyst
All right. Great thanks for taking my question.
Operator
Our next question is from Akash Tewari with Wolfe Research. Please proceed.
Joy Chao -- Wolfe Research -- Analyst
Hey thank you for taking my question.
Operator
Please proceed.
Joy Chao -- Wolfe Research -- Analyst
Okay. This is Joy on behalf of Akash Tewari. I only have one question. What are your expectations for renal safety for the Phase III trials? And should we expect any imbalance in serum creatine levels or the eGFR between the placebo and treatment arms?
Mark Timney -- Chief Executive Officer, Director
Thank you for the question. We can't specifically comment on Phase III in that respect because the information that we see is blinded and the studies are not completed and the follow-up is going on. But I can remind you of the overall safety data from ORION-1 with respect to renal safety and we have not observed any concerns on that front related to inclisiran or to the patient population at large.
Joy Chao -- Wolfe Research -- Analyst
Okay. Great. Thanks.
Mark Timney -- Chief Executive Officer, Director
And then maybe to follow up on that, when we present the combined analysis of ORION-1 and ORION-7 at EAS in the various patient groups with various degrees of renal function, we will be providing more details at the EAS meeting later in May.
Joy Chao -- Wolfe Research -- Analyst
OK. Looking forward to that. Thanks.
Operator
Our next question is from Jay Olson with Oppenheimer and Company. Please proceed
Jay Olson -- Oppenheimer and Company -- Analyst
Oh hey guys thanks for taking the questions. I had 2 questions. In your discussions with payers as part of the pre-commercialization work that you described earlier, how receptive are they to securing access for inclisiran? And have you had those discussions and how likely do you think you will be able to achieve that? And then I have a follow-up question.
Mark Timney -- Chief Executive Officer, Director
Jay, Thanks for the question. It's too early. It's still very early days for us with payers. We're just beginning some of those discussions. There is -- obviously with the differentiated profile of inclisiran, there's a lot of interest to better understand exactly where this fits for the patients that is applicable for. And as I said it, it's early days to see how that would have an impact on access for launch. But I could tell you it's -- there's a lot of excitement about the potential for the product.
Jay Olson -- Oppenheimer and Company -- Analyst
And then, I guess, separately, there are a number of new classes of drugs in development for the treatment of non-alcoholic fatty liver disease. And these patients typically have elevated LDL and other cardiovascular risk factors. Of the new classes of drugs that are in development for fatty liver disease, some of them increase LDL and some of them lower LDL. So I was wondering if you could share with us your thoughts about how inclisiran might be used in patients with fatty liver disease and potentially in combination with some of these new classes of drugs to treat fatty liver disease and whether or not these dynamics have entered into any potential strategic partnering discussions you may have had.
Mark Timney -- Chief Executive Officer, Director
Thanks. Thanks again for the question, Jay. The -- I'm going to hand over to Peter to comment on this. But also, I just want to point out that it's interesting with these patients and obviously, as you would imagine, we have a number of these patients in our studies. They do actually die. The majority actually die of cardiovascular disease and not fatty liver disease, which is an important point to note. Peter, would you like to comment?
Peter Wijngaard -- Chief Development Officer
Yes. Yes, just to follow up on that, Jay. As you stated yourself, many of these patients with fatty liver disease have elevated LDL-C or even have increase elevated LDL-C based on that treatment. They're getting specifically either development 12 or available products for that part of their mobility of the disease or the state that their having. Obviously, it's important in those patients to lower LDL-C. And as Mark said, we have a proportion of patients that are likely to have that liver disease in our Phase III program, so we will be able to evaluate also in our Phase III how well we -- inclisiran lowers LDL-C in those patients.
Jay Olson -- Oppenheimer and Company -- Analyst
Great thank you very much
Operator
Our next question is from Mayank Mamtani with B. Riley FBR. Please proceed
Mayank Mamtani -- B. Riley FBR -- Analyst
Good morning thanks for taking my question. Mostly, 2 follow-ups. Number one, on the payer research, I understand it's early, but could you help us connect the dots that the message around adherence and obviously the big push from PBMs and payers to be able to address that? How is that resonating in some of the early work that you're doing and given the profile of the drug, the once every 6 months, longer acting that are generally considered better compliant products. So the number one on that. And the number two, on group two on the switch. How -- just taking a step back, how -- is there like a scenario where you see an induction plus maintenance, induction being behind the word and maintenance being the once every 6 monthly dose. Just if you hold the data like 3 to 5 years, is that like a scenario you could see and maybe unless -- in a little more. And then I have a quick follow-up.
Mark Timney -- Chief Executive Officer, Director
Thanks, Mayank. Again, as I say for the payer research, all that I can really say at the moment is that there is excitement around the profile among the payer community. It really is early days as we think about this. Normally, when you think about engaging with payers you have to be somewhat closer to launch before they really engage in these meaningful discussions. However, what we have seen certainly in my experience and unparalleled interest in engaging with us. And you're correct, adherence is a major issue. We've seen how much of it an issue it is even for statins that have been the mainstay of therapy for many years, and they just -- there just are no solutions for this. I can tell you in my previous role at Merck, I've spent a lot of time and energy and resources trying to solve this particular issue without great success. So we know we have something that is meaningful to be able to contribute to this issue.
Peter Wijngaard -- Chief Development Officer
Yes. Thank you, Mayank. On your second question, ORION-3 group two was specifically designed to collect and safety tolerability and efficacy data from switching patients from evolocumab to inclisiran. That will be currently our -- are collecting. And your question specifically to whether would be a scenario that is induction of an antibody followed by inclisiran is not in our thinking for this. We want to have the ability to switch places on an antibody to inclisiran to have them continue with therapy with inclisiran. These patients are being treated for their LDL-C lowering for very livelong. So the notion of an induction therapy with a perceived rapid response with an antibody and then within an siRNA therapy thereafter is not really clinically relevant in these patient populations. And second, when you look in more detail at our data on inclisiran, particularly from ORION-1, but you will see later on when we present ORION-7 in more detail as well. The onset of action of inclisiran is happening actually quite fast. We have within 14 days of initiation of therapy. You already have more than 60% of your LDL-C lowering capacity achieved. So this notion of induction says maintenance of an antibody and then inclisiran is not really clinically relevant.
Mayank Mamtani -- B. Riley FBR -- Analyst
Okay. Great. And then just my quick follow-up was would you be open to this year contracts of value based company to some of these contracting discussions where maybe charging an upfront that is comparable to a generic price, but then obviously, once you realize some of the benefits on adherence or even outcomes longer term, would that be a potential option you'll be open to? It's actually before the outcomes trial results.
Mark Timney -- Chief Executive Officer, Director
Yes, it's obviously -- it's too early to be talking about anything that's closely related to pricing, but I would say we are going to be very open due to the differentiated profile being creative and really what it comes back to and what I'm more focused on, Mayank, is patient affordability. That is the critical piece for me. We start there, and then we work backwards with the payers to understand access. So that's the focus of the discussion.
Mayank Mamtani -- B. Riley FBR -- Analyst
Great. Thank you for taking my questions.
Operator
We have reached the end of our question-and-answer session. I would like to turn the floor back over to Mark Timney, Chief Executive Officer for The Medicines Company, for closing comments.
Mark Timney -- Chief Executive Officer, Director
Thank you very much, and thank you all for your questions this morning. Inclisiran's unique profile, its vast global market opportunity and long-dated exclusivity really set the stage for significant shareholder value creation. This is the countdown year for inclisiran. Well, as you can see we're moving very quickly through Phase III trials. We're really encouraged by the clinical and safety profile and expect the Phase III data to read out in the third quarter.
In parallel, pre-commercialization work is ongoing, and it affirms the highly competitive profile of inclisiran. The remainder of the Board and the management team are fully aligned, and we're committed to unlocking the value of inclisiran for its shareholders and ultimately, the people who would benefit from this unique therapy.
So with that, I'll close the call, and I wish you all a very good day. Thank you.
Operator
Thank you. Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.
Duration: 50 minutes
Call participants:
Krishna Gorti -- Vice President of Investor Relations
Mark Timney -- Chief Executive Officer, Director
Chris Visioli -- Chief Financial Officer
Paul Choi -- Goldman Sachs -- Analyst
Peter Wijngaard -- Chief Development Officer
Tazeen Ahmad -- Bank of America -- Analyst
Jessica Macomber Fye -- JP Morgan Chase & Co -- Analyst
Umer Raffat -- Evercore ISI -- Analyst
Pam Barendt -- Cowen and Company. -- Analyst
Yasmeen Rahimmi -- Roth Capital Partners -- Analyst
Joel Beatty -- Citi -- Analyst
Dae Gon -- SVB Leerink -- Analyst
Madhu Kumar -- Robert W. Baird -- Analyst
Joy Chao -- Wolfe Research -- Analyst
Jay Olson -- Oppenheimer and Company -- Analyst
Mayank Mamtani -- B. Riley FBR -- Analyst
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