Good day, and thank you for standing by. Welcome to the Illumina Investor Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a Q&A session. To ask a question during the session, you'll need to press star one on your telephone. If you require any further assistance, please press star zero. Now I'd like to hand the conference over to your speaker today, Mr. Brian Blanchett, for introductory remarks.
Good afternoon, everyone. Thank you for joining on such short notice to discuss our acquisition of GRAIL. If you've not had a chance to review today's press release, it can be found in the investor relations section of our website at illumina.com. Participating for Illumina today will be Francis deSouza, President and Chief Executive Officer, Sam Samad, Chief Financial Officer, and Charles Dadswell, General Counsel. We are also pleased to welcome Hans Bishop, GRAIL's Chief Executive Officer. Each leader will share some remarks, and then we will open the call for some questions. This call is being recorded, and the audio portion will be archived in the investor section of our website. It is our intent that all forward-looking statements made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties.
Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon current available information, and Illumina assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Illumina files with the Securities and Exchange Commission, including Illumina's most recent Forms 10-Q and 10-K. With that, I now turn the call over to Francis.
Thanks, Brian Blanchett. Good afternoon, everyone, thank you for joining us on such short notice. Today, we announced that we have reacquired GRAIL. While GRAIL is now a wholly owned subsidiary of Illumina, we will hold GRAIL separate and independent until the European Commission finishes its review. We made the decision to acquire GRAIL and hold it separate until we've received regulatory approval because it's becoming clear that we will most likely not have a decision from the regulators before the agreement expires in December. The stakes here are high because, simply put, this deal saves lives, we feel a moral obligation to ensure that the deal has a full review. Cancer kills 10 million people annually worldwide and 600,000 people in the U.S. Detecting cancer earlier saves lives. Today, the majority of cancers are found too late, when outcomes are often fatal.
Current guideline-recommended screenings are critical, but in the U.S., they cover only five cancers and only screen for a single cancer at a time. Cancers responsible for nearly 71% of cancer deaths have no recommended early detection screening. GRAIL's revolutionary Galleri test has the potential to reduce cancer mortality, detecting more than 50 cancers across all stages, 45 of which don't have any recommended screening in the U.S. Because it can be cheaper and more effective to treat an early-stage cancer than a late-stage cancer, GRAIL's test can result in enormous savings in the healthcare system. Right now, GRAIL's multi-cancer early detection test is available in the U.S. to those able to pay $950 out of pocket. We want to provide the financial support, expertise, and scale to get it widely distributed and covered by insurers.
We estimate that with Illumina's acceleration, the Galleri test can conservatively save 10,000 additional lives in the U.S. and additional lives in the EU over the next nine years. Reuniting Illumina and GRAIL is the fastest way to make this test available to everyone, everywhere. We will continue to work with the regulatory bodies in the EU and the U.S. on this acquisition. In Europe, we are in a phase II review with the European Commission, we'll likely receive a decision in Q1. In addition, we are challenging the EU's jurisdiction to review the merger of these two American companies because GRAIL has no existing or firm plans for business in Europe. We look forward to receiving a decision from the General Court of the European Union in early 2022.
As proof of our commitment to and respect for the EC process, we will hold GRAIL separate and independent with no integration of operations until the EC review is completed. There is no impediment to closing in the U.S. We will continue to work with the FTC on their administrative review of this deal and any associated legal processes. Illumina scientists first discovered the potential to detect cancer from genomic signals in blood in 2013. We recognized the enormous potential this could have to save lives and staffed a team to work on it immediately. We spun GRAIL out in 2016 to raise almost $2 billion for the necessary large clinical studies. The GRAIL team, many of them former Illumina employees, succeeded beyond our expectations and commercially launched the Galleri test in June this year.
Reuniting GRAIL with Illumina now is the fastest way to make this test globally available and accessible. After integration, we will leverage Illumina's capabilities to make this test available in doctor's offices everywhere, covered by insurance. For example, GRAIL will benefit from Illumina's scale in procurement and manufacturing, large-scale genomic testing labs, commercial reach across 140 countries, and expertise in market access that has helped get coverage of genomic testing for over 1 billion people around the world. These capabilities will expedite scaling and coverage of the test. This deal has the potential to not only benefit thousands of people, but also benefit the industry as a whole. Our vertical acquisition of GRAIL is pro-competitive and will accelerate the development of all types of early cancer detection tests. GRAIL and Illumina are not competitors and have no overlap in product offerings.
We have shown that our entry into clinical testing markets like NIPT and cancer therapy selection has been pro-competitive. After we entered NIPT, for example, the number of providers increased, costs decreased, prices dropped, and reimbursement expanded. Most importantly, more families benefited from this technology. We plan to do the same thing in the multi-cancer early detection space. Our business model is successful when the industry as a whole expands. We want to increase the number of companies running genetic tests, ours and others. We have a track record of supporting competitors and selling sequencers to enable them. To that end, Illumina has made an open offer available on our website, contractually committing to continue to make all our products available to every oncology customer on the same timeline and at the same price as GRAIL. We remain committed to a fair and open cancer diagnostics marketplace.
As always, Illumina will continue to innovate in the field of genomics and develop new life-changing innovations and technologies, like those that created GRAIL years ago. Now I'll turn the call over to Chuck.
Thanks, Francis. While we respect the legal process in both the U.S. and the European Union, all companies, including Illumina, should be entitled to a timely, fair, and predictable process for potential acquisitions to be assessed on the merits of the deal. As Francis mentioned, there is no legal impediment to closing in the U.S. The FTC withdrew its request in federal court for an injunction to prevent the closing. The FTC administrative trial is scheduled to begin August 24th. We expect it to take several weeks, with a decision likely issuing in Q1 2022. We look forward to presenting our case during the FTC trial, showing that this acquisition is pro-competitive and life-saving.
Moving to Europe, on April 29th, 2021, Illumina filed a complaint in the General Court of the European Union to annul the European Commission's review of the GRAIL acquisition because neither the European Commission nor any European member state has jurisdiction to review this acquisition between two American companies. The General Court has granted Illumina's request to have the case heard on an expedited basis. We anticipate a hearing this fall with a decision by the end of the year or early in 2022. We will continue to work with the European Commission during the pendency of our court challenge. As in the U.S. process, we will present substantial evidence demonstrating that this acquisition is pro-competitive and should be approved.
The European Commission initiated its phase II review on July 22nd, 2021, and we anticipate phase II being completed in early Q1 2022. While the European Commission reviews the acquisition, Illumina and GRAIL decided that moving forward is in the best interest of patients, shareholders, and public health. Illumina is committed to cooperating with the European Commission's investigation until a final decision is reached and is holding GRAIL separate to respect the European Commission's review. Under the hold separate agreement, Illumina and GRAIL will each continue to operate as independent legal entities, and Illumina has committed not to integrate GRAIL until completion of the process ongoing in Europe. We will abide by any outcome ultimately reached by the legal process. Now I'll turn the call over to Sam.
Thank you, Chuck. I'm very excited about the future that GRAIL and Illumina can create together, and I will now highlight a few financial details regarding the acquisition. As a reminder, the merger consideration for GRAIL included stock and cash. In addition, GRAIL shareholders were given the option to elect either a contingent value right or additional shares of Illumina. Excluding Illumina's ownership and including other adjustments, we plan to issue approximately 9.8 million shares and deploy approximately $3.5 billion in cash as part of this acquisition. About half the GRAIL shareholders elected to receive contingent value rights. In addition, GRAIL's cash balance is approximately $500 million after accounting for some transaction-related costs. Please note that more details on the transaction consideration can be found in today's press release.
Going forward, and starting on our Q3 earnings call, we intend to provide full segment financial reporting for our core business and separately for GRAIL. We will also provide consolidated financial reporting for Illumina Inc. As we indicated on our Q2 earnings call, our core business is incredibly strong, and we are very confident in the Q3 and full year 2021 guidance we provided as it relates to our core Illumina business excluding GRAIL. We are not providing P&L guidance for GRAIL at this time, but intend to do so at a later date. From a cash funding standpoint for GRAIL, the $35 million continuation payments we had been previously providing them up until closing represents a rough approximation of GRAIL's expected monthly operating cash needs for the rest of 2021, and we expect this number to increase in 2022.
I will now invite Hans Bishop, the CEO of GRAIL, to say a few words before Francis shares his final comments.
Thank you, Sam. I'd like to reiterate how excited I am that Illumina has now acquired GRAIL. We at GRAIL are a mission-based company with a goal of finding cancer early when it can be cured. Joining forces with Illumina is a huge boost for our mission. It will enable us to achieve scale faster, ultimately preventing more late-stage cancers with the potential to save many more lives, both here in the U.S. and around the world.
This is an incredibly exciting time at GRAIL. Having just commercially launched our Galleri test earlier this year, we're already finding early-stage cancers that otherwise would've been missed. We expect adoption to continue increasing and look forward to leveraging Illumina's expertise to expedite regulatory approval and drive broader adoption. With that, I'll hand the call back over to Francis for his final comment.
Thanks, Hans. From helping fight the COVID pandemic to matching cancer patients to therapies, our mandate is to save lives and transform healthcare by harnessing the power of genomics. Our acquisition of GRAIL supports this mandate and is driven by our belief that life-saving cancer detection tests should be available to as many people as possible, as quickly as possible. Illumina and GRAIL are a powerful combination. We envision a future where people around the world can access the Galleri test as part of their normal annual physical examination. Just as now you're able to be tested for early-stage diabetes and high cholesterol, you will soon be able to receive multi-cancer early screening from a simple blood draw in your doctor's office. This will be nothing short of transformational for human health. Now, I'll invite the operator to open for Q&A.
As a reminder, to ask a question, you'll need to press star one on your telephone. To withdraw your question, press the pound key. Your first question comes line of Doug Schenkel with Cowen.
Hey, good afternoon, and thank you for taking my question. Acknowledging that merged regulatory matters are not my strongest area of expertise, this on the surface seems like a pretty aggressive approach. Simply put, in your prepared remarks, I didn't hear anything that suggested you've heard that the FTC will not ultimately attempt to block this transaction. To be to the point as much as possible, has the FTC agreed to stand down?
Thanks for your question, Doug. The reason we took this step today, and it's really two parts to the step we took today, first, we acquired GRAIL, and two, we're keeping separate, is because we feel the stakes in this deal are so high, specifically that over 10,000 lives could be saved by the acceleration that Illumina provides the GRAIL test in making it accessible to everyone. The stakes here are so high that we wanted to make sure this deal gets a full review. As we pointed out, the decisions we're expecting from the review come in Q1, and so would come after the deal timed out on December 20th. What this step does is it makes sure that the deal gets a full review and that we get to a decision from the two European actions that are in play.
It also respects the European regulatory process because it keeps GRAIL separate, and so we won't do any integration until then. In terms of the FTC, there is no impediment for us to closing the deal here in the U.S. right now. We are going to continue to work with the FTC on their administrative process and any follow-on process from that. There is no hurdle for us crossing right now. Again, what we wanted to do was make sure this deal got the review that it deserved, frankly, based on its merits. As we said, as always, we will abide with any outcome from the legal process.
Okay. Helpful, Francis, again, to be direct, that's not really my question. My question is, has the FTC said that you can move forward and you're in the clear? Based on your answer, I'm guessing the answer is no. Recognizing there is still FTC risk here, how do you assess, A, the risk that the FTC comes back, B, the risk that you're further damaging your relationship with the U.S. government and specifically the FTC, which could impact future strategic endeavors, which have been an area of difficulty for you over the last few years, and C, the risk that you are not just holding back GRAIL, but causing distraction and wasted efforts that are ultimately not in the best interest of Illumina shareholders?
Be very specific. There are two things that are going on with the FTC. One, the FTC has eliminated the hurdle to closing. We had a temporary restraining order, with the FTC that they went to court to petition to remove. The FTC has said there is no hurdle to closing in the U.S. right now. Specifically what the FTC has said is there is an administrative review process that starts next week. That's what the FTC has said to us, and we're still marching down that process. We are using, obviously, the full legal process here in the U.S., and again, we will work with the FTC through that process and abide with any outcome of that process. Availing ourselves of the process shouldn't necessarily damage the relationship with the FTC.
Okay. All right. Thanks, Francis.
Your next question comes from the line of Tycho Peterson with JPMorgan.
Hey, thanks. Francis, you put out an 8-K this afternoon that the European Commission is going to impose a fine up to 10% of consolidated annual turnover. Can you talk to that aspect? Is there any risk the FTC might do something similar?
Hey, Tycho. This is Charles Dadswell, General Counsel. Where we stand with the European Union is, first and foremost, we respect the processes ongoing there. We've challenged the European Union in two places. The first one is the regulatory process with DG Competition. We believe that, and we'll continue to work through that process with the European Commission. We expect, as Francis mentioned, that that process would end in Q2 of 2022, excuse me, Q1 of 2022. The second place that we've challenged them is in the General Court, in the EU. We've challenged them because we don't think they have jurisdiction over this deal. That case is, we don't have a hearing date yet. We expect a hearing date any time. We expect to have a decision from the General Court on whether or not the EU has jurisdiction over this deal sometime in Q1 of 2022 as well.
As far as the fine that you're talking about, we did put that out in our 8-K. That possibility does exist. If at the end of this conclusion, there is a decision, and we will respect that decision, that they in fact did have jurisdiction over the deal, there's the possibility that they could fine us up to 10% of one year's revenue, as we disclosed.
In terms of the FTC, again, there is no legal hurdle to us closing in the U.S. from the FTC. There's no grounds for a fine from the FTC.
Francis, the benefits of closing but not integrating, I am just curious, you could obviously have done a broader distribution agreement with GRAIL to get the product out there more broadly. What is the real advantage to having closed if you are actually not going to integrate? Could you have done broader access another way?
Yeah. The path we're on is such that the decision from the review that's happening in Europe won't happen until Q1. This acquisition contract expires in December of this year. The advantage of acquiring GRAIL is to make sure that this deal gets the full review that it deserves from the European Commission. That's the advantage of acquiring them today. To respect the European process, which we do, we want to make sure that we hold the company separate and don't do any integration until we get that decision from the European Commission.
Last one for Sam, I appreciate you're not going to give P&L guidance, but have your spending assumptions changed at all from when you first announced the deal, in terms of how we should be thinking about the burn around GRAIL in the back half of the year?
Not necessarily, Tycho. I think we're still in the same ballpark, but we are going to update these estimates. Obviously, a lot of circumstances have changed in terms of timing of the deal and our inability to integrate at this point. We will update these assumptions. I would say materially, no significant change from when we announced the deal.
Your next question comes to the line of Puneet Souda with SVB Leerink.
Hi, Francis. My first question is really, if the General Court of the European Union is positive, I think the path is obviously clear, but if that's not the case down the line, and the same applies to FTC in some ways, maybe let me ask you the first question on Europe, would you be able to sell Galleri as a test in Europe if there were some objections to the deal down the line? Would that impact your market opportunity that you have anticipated so far?
Yeah. Let me talk about the process in Europe. There are two decisions that we expect to come out from Europe, from two different bodies in Q1. One is from the General Court, where we're challenging the jurisdiction of the European Commission to review the deal. The second one is from the European Commission on the phase II review. If we are successful in either of those, we are free to integrate GRAIL into Illumina. We need one of those two decisions to be positive, we're not only closed, we can start the integration. If we don't prevail in phase II, we'll continue down sort of the legal process in Europe and appeal that decision. Right now, GRAIL has no plans to sell their test in Europe.
Even if you look at their sort of 10-year plan, they have no firm plans to launch their product into Europe. If we succeed in acquiring them and integrating, we would accelerate those plans, and we do have in our model some revenue that we'd get out from Europe from launching the GRAIL test in Europe. This is binary though. Either we are able to acquire and merge GRAIL and launch the product globally or not. It wouldn't be a case where we wouldn't launch the product in some markets.
Okay, thanks. I think the other major question really here is, this is a test that you're offering today at $950 out of pocket. We've seen, obviously, with single indication tests in the past, they will require FDA approval. This is a screening test and very likely require, obviously, Medicare and then USPSTF recommendation support. Given all of that, has your thinking changed at all in terms of the timing of obtaining that? When should we expect GRAIL to have meaningful revenue, which is very likely going to be after those USPSTF recommendations and guideline inclusions that will ultimately drive the commercial payers to pay for this test?
Yeah. Let's go through your questions. One, once we are able to integrate GRAIL, we absolutely will leverage the expertise we have in Illumina in a number of areas, but including, as you said, our regulatory expertise and very importantly, our market access team. That will accelerate the plan, in terms of making the GRAIL test accessible and reimbursed across the 50 states and around the world from their current plan, and we've shared some of those ideas with you so far. Our team has a huge amount of expertise in this area. We have helped deliver reimbursement to over 1 billion people around the world for genomic tests across the categories that we're in today. Our team has good expertise in accelerating reimbursement for genomic tests, and we'll leverage that.
In genomic testing, as you know, whether it's NIPT or cancer therapy selection, even today in the U.S., those are not cleared tests. They're still LDTs. If you look at some of the leading providers in that space. Getting clearance is not a prerequisite for reimbursement. You can get reimbursement even on LDTs, and we expect that's the path that'll probably come to fruition first for the GRAIL test.
Okay, last one, if I could squeeze in. In terms of the STRIVE trial you have, I believe the enrollment is completed there, and in the U.K. NHS trial, where you're enrolling, I believe, more than 150,000 patients, any updates that you can provide on that front? Those are large-scale trials that would be needed in order to gain, ultimately, major regulatory approvals and reimbursement. Wondering, obviously, one of the key parts of this acquisition was Illumina's presence globally and be able to drive these tests internationally, including in Europe. I'm just wondering, does this impact your position in England, U.K., specifically? Thank you.
Let's talk through those questions, Puneet. We continue to hear from the GRAIL team as they've talked externally, that there is good progress in terms of, well, obviously recruiting for the STRIVE trial, as you said, but also with the NHS. They are planning to have the tests in the first phase available to 165,000 people in the U.K., scaling up to a million by the 2023/2024 timeframe, then making it available population-wide. That's a historic deal. It's a historic deal in terms of making this multi-cancer test available to a population, and it's also historic in terms of the scale of that deal. It's really exciting to hear the positive progress coming from GRAIL with the NHS. We absolutely plan to accelerate the global deployment of GRAIL. That's true across the U.S. and leveraging our capability.
Our commercial team has a presence now in 140 countries. We place products in 140 countries around the world. That is a commercial presence that we will be leveraging for GRAIL. In addition, we have large-scale production labs that run genomic tests, and that's something we can leverage for GRAIL as well. If you look at their plan today, for the next five years, their plan was really, as an independent company, to be in the U.S., Canada, and the U.K. Our plan is to accelerate their entry into Europe, also more broadly into Asia and Africa and Latin America. That's great from, obviously, a business perspective, but it's also crucial in terms of making this life-saving test available to many, many more people around the world.
In the interest of time, we please ask that you limit yourselves to one question. Your next question comes from the line of Derik de Bruin with Bank of America.
Hi, good afternoon.
Hi, Derik.
Hey. In the event that you can't close this, if things don't go your way, can you unwind this? Are you on the hook for the whole $8 billion in that case?
The way it would work is, we'd obviously work through the appeals process, and this would take multiple years, right. You are talking about 2025-ish, and maybe even a little after, when we would be required to unwind it if we had to. At that time, we'd look at the whole spectrum of options, including an IPO. It's completely unrelated to the $8 billion. We paid those shareholders out today. We own GRAIL today. We are the shareholder of GRAIL. At that point, we'd look to maybe spin out and take public the GRAIL asset, the early screening test asset. Again, at that point, we'd assess what the best option was. An IPO seems like a good candidate.
A question for Hans, if I may. Hans, have you been successful in doing any deals with independent delivery networks, or is it still more concierge-focused in terms like this? Just sort of like, where are your current commercial opportunities and agreements?
Hey, Derik, Hans is not on the call, so you'll have to move on.
Okay.
Your next question comes from the line of Tejas Savant with Morgan Stanley.
Hi, guys. Good evening. Just a two-parter for Chuck here, if I may. Chuck, as you sort of tried to handicap the possibility of not running afoul of any gun-jumping laws, and sort of weighed that versus the possibility here that you could have extended the deal deadline beyond December 20th, how exactly did you sort of come to this decision? If you could just give us some context and background around that would be terrific.
Yeah, sure. First and foremost, our goal was to make sure that we were respecting the processes that were taking place in both the EU and in the United States. That's the reason that we put the hold separate in place. We knew the deal was going to time out on December 20th. Looking at our options at any of those venues, we didn't think that we had the runway to get past the December 20th date. With the FTC administrative trial, we didn't think we were going to get a judgment from the judge there until after December 20th.
The case in Luxembourg that we have in front of the General Court challenging jurisdiction of the European Commission, we don't have a hearing date, and we don't think that we'll get a decision until probably after the end of the year, which again, gets us past the timeout date on the agreement. With the European Commission, as we've just entered into the phase II process, we looked at that, and we don't think we have any likely chance of getting clearance through that before December 20th either. We took this kind of action, but we did it to respect the processes, and that's why we had the hold separate.
Got it. Fantastic. Thank you, guys.
Your next question comes to the line of Sung Ji Nam with BTIG.
Hi, thanks for taking the question. Would you be able to comment on whether the diagnostic aid for cancer test and the MRD test, the timeline that you guys had discussed with your initial announcement would still be on track at this point, or kind of what the new timeline might be?
Yeah, there's no new update on those two. Both the GRAIL team and us are enormously excited about the potential for GRAIL's approach to MRD, which is tumor-independent, using the same technology that they use for their screening test. We think that's a really innovative way to do MRD, and we're excited about the opportunity for the GRAIL technology in that space. Similarly, we think the DAC serves an important need in the market in terms of helping people who are symptomatic, but can't find the cancer. Again, no new update in terms of timelines there, but continue to be enormously excited about the potential to help patients and fill a big market need there.
Great. Thank you.
Your next question comes to the line of John Sourbeer with UBS.
Thanks for taking my question. My question, I guess, is for Francis or Chuck. GRAIL has made announcements on entering into the U.K. with the NHS. Have you had any discussions with the CMA there? My understanding is in the U.K. often the CMA may investigate an acquisition post-close and propose remedies. Is there any updates you can provide around that?
Yeah, John, I'll start. Right after we announced the acquisition, we got some initial inquiries from the CMA. We started a dialogue with them. We went back and forth a couple of times, and they came back to us and said, "Yeah, we don't have any further questions about what you guys are doing with GRAIL." That was the whole of the conversation we had with the CMA.
Your next question comes to the line of Patrick Donnelly with Citi.
Great. Thanks. Chuck, maybe a follow-up on one of the earlier questions as you kind of explored the different options here. Is there precedent for this kind of closing ahead of the approvals? I guess when you looked around, are there success stories that maybe you could point us towards or talk about? Just don't recall kind of seeing this before.
Yeah. What I will say is that, first and foremost, again, we wanted to respect the process that we have ongoing in the European Union. When we looked at the hold separate, we actually used a form of hold separate that is contained on the EU's website. This is not something that is completely unprecedented because we are using their form of the hold separate. That is kind of the way that we have looked at this.
Okay. Sam, maybe just a quick one. You might have mentioned, but the 10 million shares, just timing around the issuance there. I just want to make sure I'm clear on that.
Yeah. We will be working through this over the next few days, Patrick. That's part of the consideration.
Understood. Thank you.
You can assume that from a dilution standpoint, it will impact our share count for the third quarter and the fourth quarter, obviously on a weighted average basis.
Okay.
You have to calculate it.
Right. Understood. Thanks, Sam.
Your next question comes from Catherine Schulte with Baird.
Hi. Thanks for the question. I guess just with the FTC, to your point, they did withdraw their request for an injunction and restraining order to prevent the deal from closing. I believe they did so with the understanding that the EU probe would prevent the deal closure. It wasn't needed, and they had it dismissed without prejudice, meaning they could file again if the EU investigation ended. Just with that intent behind their dismissal, I'm just curious why you think this won't rub the FTC the wrong way, and are there any actions that they could take in response. Thanks.
Yeah, Catherine, you've got that exactly right. When the FTC went into court and asked for the motion to dismiss on the PI hearing, that dropped any impediment that we had over closing in the U.S. We have the hold separate in place to respect the European process, we'll continue to work through that process with them. We'll continue to work through the administrative process with the FTC. We are not sure exactly when that will land, but we think that we will probably get a decision on the FTC case sometime in the first quarter of next year.
Great. Thanks.
Your next question comes to the line of Jack Meehan with Nephron Research.
Thanks. Good afternoon. Just curious, what's changed over the last two weeks, which is leading you to close the deal today? At the time of earnings, you knew the deal was going to phase II review, and you said this was really not having the regulatory review done before the deal expires, but couldn't you just extend the deadline like you did with PacBio?
A couple of things, I'd say. Let me start with extending the deadline, right? So we had in the contract the ability to extend the deadline from September 20th to December 20th. That's what we were contemplating the whole time. What has happened over the last couple of weeks is, as we've entered phase II review in the European Commission, with some of the dates moving out, it's now become clear over the last couple of weeks that the decision from the EC is going to come after the December 20th date on both fronts, right? So we haven't yet got a date for the case in front of the European General Court. What was likely to have been a Q4 decision is now likely a Q1 decision.
Similarly, the phase II review has sort of slipped in the last couple of weeks, and it's now also looking like a Q1 decision. That's driving the timing that says, in order to make sure that this deal, which again, has such high stakes in terms of lives saved, gets its full review, it's necessary for us to acquire the company now, but to respect the process by holding the companies separate. That's the step we're taking.
Okay, and you have no further questions at this time. I'll turn it back to Brian Blanchett for any closing remarks.
Great. Thank you. As a reminder, a replay of this call will be available in the Investors section of our website, as well as through the dial-in instructions contained in today's press release. This concludes our call, and thank you for joining us today.
This concludes today's conference call. Thank you for participating, and you may now disconnect.