Amarin Corporation PLC (AMRN) 2014 Q2 法說會逐字稿

Greetings and welcome to the Amarin Corporation's second quarter 2014 results conference call. (Operator Instructions). I would now like to turn the conference over to your host, Mr. Mike Farrell, Controller and Senior Director of Investor Relations. Thank you. You may begin.

Welcome and thank you for joining us today.

Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include but are not limited to our current expectations regarding our commercial and financial performance, including levels of Vascepa sales, revenues and other commercial metrics, expenditures, supply-related activities and the adequacy of our financial resources, our current expectations regarding regulatory filings, government agency decisions and potential label expansion, our current expectations regarding our cardiovascular outcomes study such as enrolment and the potential implications on such study of our regulatory process, our plans to protect the commercial potential of our product candidates and approved products through patents, regulatory exclusivity, trade secrets and manufacturing barriers to entry, and our current expectations regarding the effect of our new co-promotion agreement on our business.

These statements are based on information available to us today, August 7, 2014. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into such as mergers, acquisitions, dispositions, joint ventures or any material agreement that we may enter into, amend or terminate.

For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statements section in today's press release and the risk factors section of our quarterly report on Form 10-Q for the three and six months ended June 30, 2014. These documents have been filed with the SEC and are available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents.

The call is intended for investors in Amarin and is not intended to promote the use of Vascepa outside of its approved indication. Finally, an archive of this call will be posted to the Amarin website in the Investor Relations section.

In addition to myself, on today's call from Amarin are John Thero, our President and Chief Executive Officer, Steve Ketchum, our President of R&D, Joe Kennedy, our Senior Vice President and General Counsel, and Aaron Berg, our Senior Vice President of Marketing and Sales. I will now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Good afternoon. Thank you for joining us today. On today's call we'll discuss Amarin's recent commercial, operational and financial performance, update our SPA rescission appeal status for the FDA, and then take questions from analysts and investors.

In Q2 2014 we experienced further Vascepa prescription and revenue growth. Net product revenues for the three months ended June 30, 2014 were $12.6m, representing a 129% increase over net revenues of $5.5m reported for the same period a year ago and a 15% increase over net revenues of $11m reported for the first quarter of this year. Underlying this growth are broader productivity increases as we achieved this growth with lower SG&A costs than a year ago.

Our net cash burn dropped to $13.8m in Q2, 2014 resulting in year-to-date net cash burn through June 30 of $41m. These results put us on track to achieve our previously-stated target of full-year 2014 net cash outflow of not more than $80m, and reflect a pattern of significant cash flow improvement over the past several quarters. In comparison, our net cash burn in Q2, 2013 of $52.4m was more than three times higher than Q2 of this year.

Our prescription and revenue growth in Q2 was led by the focus of our sales team on educating the highest prescribers of competitive therapies on the benefits of Vascepa. Our growth came primarily from these targets, which is important because these targets also hold the potential for significant future growth.

As described previously, to reach positions that our sales team does not have the bandwidth to address, we entered into a co-promotion agreement with Kowa Pharmaceuticals America, under which Kowa will be promoting Vascepa to more than twice the number of physicians being called on by the Amarin sales team.

Kowa's co-promotion efforts commenced in May and further accelerated in June. While, as we've guided in the past, enough time has not yet past for such expanded promotional efforts to take root, the Kowa sales team is now actively and enthusiastically promoting Vascepa to physicians, many of whom are being detailed for the first time on the benefits of Vascepa. We anticipate that Kowa's co-promotion efforts of Vascepa will be one of the key drivers of further Vascepa sales growth later this year and beyond.

Aaron and Mike will provide additional comments on our operational and financial performance. I now turn the call over to Aaron Berg, our Senior Vice president of Marketing and Sales, for a commercial update. Aaron.

Thank you John. During the second quarter we witnessed an increase in the rate of Vascepa prescription growth. Normalized prescriptions for the quarter ended June 30, 2014, as estimated based on data from Symphony Health Solutions and IMS Health, totaled approximately 110,000 and 93,000 respectively and grew approximately 18% and 19% respectively over prescriptions during the first quarter 2014. Such prescription growth was primarily driven from higher decile physicians targeted by Amarin sales representatives.

We've also grown Vascepa total prescription market share in the prescription omega-3 market from 6% in March to 8% in June, despite the availability of generic Lovaza. As was true in Q1, in Q2 the strongest-performing group of targets were the highest-decile physicians which we target with our sales force. I will talk in a moment about the recently commenced co-promotion efforts by Kowa which are now introducing Vascepa to a larger audience of physicians.

We know that Vascepa usage is impacted by sale detailing. In the highest value group or the highest decile prescription omega-3 prescribing physicians, those in deciles 8 to 10 as targeted by Amarin's direct sales force, overall Vascepa new prescription share rose to 16% in June from 14% at the end of Q1.

We regularly hear overwhelmingly positive feedback from clinicians regarding their patients' favorable treatment responses to Vascepa. This includes comments regarding the safety and tolerability of Vascepa and consistent physician feedback regarding the positive effect on patient lipid management and inflammatory parameters. We also continue to hear stories of patients being switched to Vascepa from other triglyceride-lowering therapies and witnessing notable improvement, particularly with respect to attaining desired triglyceride reduction without increasing LDL cholesterol.

Some of these physicians have begun publishing their clinical experiences. One of the physicians who began prescribing Vascepa a year ago is Dr. Richard Castaldo who practices medicine in upstate New York.

Dr. Castaldo took this feedback to a higher level with a hypothesis-generating publication titled, A Retrospective Case Series of the Lipid Effects of Switching from omega-3 Fatty Acid Ethyl Esters to Icosapent Ethyl in Hyperlipidemic Patients. In this publication 14 patient cases were reviewed for hyperlipidemic patients who switched to treatment with Vascepa from the first-approved prescription omega-3 therapy, a mixture which contained DHA in addition to other components. As documented in the publication, most of the switched patients experienced improvements in triglycerides and low-density lipoprotein cholesterol levels.

During the second quarter of 2014 we continued to make progress in executing our commercialization strategy, which should result in additional future revenue growth. The addition of the Kowa sales force to our existing Amarin sales force more than doubles our Vascepa detailing levels, resulting in a significant increase in reach and frequency of Vascepa promotion to high-value target physicians. Prescription data continues to confirm that increased frequency of quality calls to high-decile prescribers will generate increases in prescription growth.

Amarin has approximately 130 sales representatives directly promoting Vascepa. Kowa recently began deploying their approximately 250 sales representatives to promote Vascepa. Our product is one of the two products their representatives promote. With the required minimum level of physician one and physician two sales calls under our agreement, we anticipate that the Vascepa detailing efforts to primary care physicians and cardiologists by Kowa sales representatives will more than double Amarin's current sale detail frequency and result in our combined efforts reaching more than twice the number of target physicians that Amarin was reaching on its own.

June was the first full month that the Kowa sales force was promoting Vascepa. The Kowa sales team is leveraging their established relationships to introduce Vascepa to many physicians on whom we've never called. While very early, the anecdotal feedback regarding Kowa's initial experience with Vascepa has been extremely positive. And we look forward to seeing the impact on prescriptions later in 2014. Typically it takes approximately six months for a co-promotion relationship to begin showing significant impact, particularly when the drug being marketed is for treatment of a chronic condition.

We're very pleased with the addition of Kowa to co-promote Vascepa as well as the continued progress by our own team throughout Q2. We're convinced that Vascepa is well positioned for future revenue growth moving forward.

We've spoken in the past about the important label clinical differentiation between Vascepa and Lovaza, including that Vascepa has demonstrated that it does not increase LDL cholesterol in its approved indication compared to placebo, while trials for Lovaza for this indication showed median increases in LDL-C, bad cholesterol, of 49% relative to placebo as per the FDA-approved label for Lovaza.

In April Lovaza went generic and much of the prescription volume for Lovaza switched from branded to generic. Vascepa prescriptions continued to grow despite the launch of generic Lovaza. In Q2 we did not witness any significant switching of patients from Vascepa to generic Lovaza. And we continued to witness formulary coverage growth and tier two coverage growth for Vascepa after the launch of generic Lovaza.

This may be because payers, clinicians and patients, see the clinical value in Vascepa. And it could also be that this is not a typical generic market. The available generic Lovaza products is priced such that it is more expensive than Vascepa. The wholesale price for 120 capsules or one month's supply of Vascepa is $195.04, which is less than the price of the currently marketed generic Lovaza, which is priced at $198.50, and considerably less than branded Lovaza at $229.75.

A second generic Lovaza product was approved in June. It has a published wholesale price of $183.8. This product which has not yet been launched, while its wholesale price is slightly lower than Vascepa, is more expensive than Vascepa for most payers after adjustment for co-payment and rebate differences between a branded and generic product. Accordingly in addition to the clinical advantages of Vascepa, there is not a financial incentive for payers or pharmacies to switch patients to the generic Lovaza.

Furthermore, it's important to remember that Vascepa is not AB-rated to Lovaza, is not substitutable and provides patients with unique clinical attributes. As a reminder, branded and generic Lovaza are comprised of approximately 37.5% DHA plus approximately 46.5% EPA with the balance comprised of a mixture of other components, whereas Vascepa is over 96% EPA.

From a patient perspective, the clinical differentiation between Vascepa and Lovaza holds whether or not Lovaza is branded or generic. And from a cost perspective, our $9 co-pay card is approximately the same as, and in some cases less than the co-pay cost for generic Lovaza.

Speaking of clinical differentiation between Vascepa and Lovaza, we've commented in the past that Lovaza was approved on data from over a decade ago in small studies of patients, few if any of whom were on a statin therapy and which, as a group, had median baseline triglyceride levels above 800 milligrams per deciliter in the Lovaza arm.

It's been shown that the higher the baseline level of triglycerides, the greater the potential for reduction through therapy. During Q2 results were made available from a more recent, larger study in which median baseline triglyceride levels were in the 600s for the Lovaza arm, which is more analogous to the levels studied for other approved therapies for lowering very high triglycerides. In this broader study the triglyceride reduction from Lovaza was only 14% relative to placebo, as compared to the higher reduction seen in the older study when patients had higher baseline triglyceride levels.

For the convenience of Amarin's investors we've summarized the results of clinical studies for these competitive products in the Investor Relations section of Amarin's website at www.amarincorp.com. The data presented on our website are taken directly from the labels of the omega-3 products approved for treatment of very high triglycerides.

Thus far only one of those competitive products, all of which are mixtures of EPA and DHA, has launched, which is Lovaza. No head-to-head study has been conducted between Vascepa and these other products although, as mentioned earlier and as documented by Dr. Castaldo, there are reasons to believe that Vascepa is well differentiated from products that are mixtures of EPA and DHA, including because of the propensity for the DHA component to increase LDL cholesterol.

During Q2 we launched several marketing programs to support Vascepa sales. These include some targeted programs aimed at pulling through our managed care progress to solidify physicians' awareness of Vascepa's positive formulary coverage, and a broader celebrity campaign we announced in June, in which Amarin is partnering with Rick Harrison, star of the number one History Channel hit television show Pawn Stars, to raise awareness of very high triglycerides and treating the condition with Vascepa.

Rick is a very high triglyceride patient and speaks passionately about the importance of talking to your doctor, the need to avoid dietary supplement omega-3 products to treat this disease and why EPA-only Vascepa works for him. In the three weeks following our June one-day test we saw an immediate spike in consumer online engagement with our website, LowerMyTrigs.com. We're planning events with Rick in the months ahead and are using his image and story in some of our educational materials.

We strongly believe that Vascepa is the best product for treating patients with very high triglycerides. It's important to remember, as reflected in its current approved labeling, Vascepa not only significantly lowered triglycerides in patients with very high triglycerides, but also demonstrated a positive impact on a broad spectrum of other lipid parameters, including total cholesterol, non-HDL cholesterol, VLDL cholesterol and apoB.

Vascepa reduced triglycerides without increasing LDL cholesterol and displayed a safety and tolerability profile similar to placebo, with no adverse events occurring at the typical label cut-off of greater than 3% and greater than placebo, and only one labeled adverse event, arthralgia, occurring at a rate greater than 2% and greater than placebo. No other approved therapy for severe hypertriglyceridemia can make these claims, as only Vascepa has such a clinical profile.

As always, it's the benefit to patients and the efficacy and safety of a product that are first and foremost when marketing a pharmaceutical agent. And that's why we believe we can and will be successful in selling Vascepa.

With that, I welcome Mike Farrell, Amarin's Controller, to comment on Amarin's second quarter 2014 financial results. Mike.

Thank you Aaron. Well, I'll provide some comments regarding our recent financial results. You will find a more detailed discussion of our results in our 10-Q and press release issued earlier today.

In Q2, 2014 we recognized $12.6m in net revenues, representing an increase as compared to $5.5m in Q2, 2013 and as compared to $11m in net revenues in the first quarter of 2014. You may recall, as discussed last quarter, the Q1, 2014 results included approximately $1m in revenues resulting from a change in accounting method.

The 129% increase in Q2 revenues over a year ago also reflects increased productivity as it was achieved with SG&A expenses which were 38% lower than the same period a year ago.

On a year-to-date basis we recognized $23.6m in revenues through June 30, 2014, as compared to $7.8m in the same period in 2013. Our average price per capsule sold in Q2, 2014 approximated the average price in Q1, 2014. Cash collections from the sales of Vascepa in the six months ended June 30, 2014 were approximately $26.4m, and all our customers are current in their payments.

Gross margin during the quarter ended June 30, 2014 was 60% as compared to 48% in Q2, 2013. Gross margin for the six months ended June 30, 2014 was 61% as compared to 47% for the same period in 2013. While our gross margin may fluctuate from quarter to quarter, overall we expect our gross margin percentage to improve further beyond 2014 as we increase purchase volumes and source lower-cost API.

Our SG&A expenses in Q2, 2014 were $21.1m as compared to $34m in Q2, 2013, reflecting an intentional reduction in expenditures. SG&A expenses in the six months ended June 30, 2014 were $41.7m as compared to $73.2m for the same period in 2013. The decrease in SG&A expenses was primarily driven by a decrease in sales force staffing, marketing program spend and other general and administrative costs associated with the commercialization of Vascepa. 2013 was the year in which we commenced selling Vascepa and as such includes certain launching-related costs.

Our R&D expenses in Q2, 2014 were $11.7m as compared to $17.5m in Q2, 2013 and were $23.4m in the six months ended June 30, 2014 as compared to $39.3m for the same period in 2013. The decrease was primarily driven by a decrease in REDUCE-IT expenses, reflecting quarterly variability as the trial is now fully operational across all countries and sites, as well as lower pre-commercial inventory supply purchases and reduced staffing and overhead costs in 2014.

Under US GAAP we reported net income of $15.3m in the second quarter of 2014, or basic and diluted earnings per share of $0.09 and $0.08 respectively. This net income included $2.4m in non-cash, share-based compensation expenses, $0.1m in non-cash warrant compensation income, a $3m gain on the change in fair value of derivatives and a $38m non-cash gain on extinguishment of debt.

We reported a net loss of $10.7m for the six months ended June 30, 2014 or basic and diluted loss per share of $0.06 and $0.07 respectively. This net loss included $4.4m in non-cash share-based compensation expense, $0.2m in non-cash warrant compensation income, a $7.4m gain on the change in fair value of derivatives and a $38m non-cash gain on the extinguishment of debt.

We reported cash and cash equivalents of $150.5m as of June 30, 2014, representing a net decrease of $13.8m from reported cash and cash equivalents of $164.3m as of March 31, 2014 and a net decrease of $41m from reported cash and cash equivalents of $191.5m as of December 31, 2013. The improvement in net cash outflow to $13.8m in Q2, 2014 as compared to $52.4m in Q2, 2013 and $27.2m in Q1, 2014 reflects our focus on cash preservation and targeting spend efficiently in order to maximize Vascepa revenues and minimize cash burn.

It is anticipated that we will experience fluctuations in quarterly net cash outflows from operations. As a result of the timing of certain items, including interest payments and supply purchases, we anticipate that Q3 net cash outflows from operations will exceed Q2 net cash outflows. However, we continue to estimate that during 2014 as a whole net cash outflows will be less than $80m.

In May 2014, as previously announced, we closed on the exchange of approximately $118.7m of our outstanding senior secured convertible notes. The terms of the exchange delayed by two years the first put date on the newly-issued notes to January of 2019 and added a provision under which Amarin can trigger a change of this debt into equity if the price of Amarin's shares trades above $2.86 per share for a period of time.

Importantly, this two-year delay on the put date defers the date on which we could be forced to repay this debt until after which we expect to have completed the REDUCE-IT study. The two-year deferral also mitigates the pressure that was otherwise mounting, which could have caused the need for additional financing which we are seeking to avoid.

As previously discussed, it is good corporate governance for qualifying public companies to have an effective shelf registration statement. Amarin has had a shelf registration statement in place for years, but it has recently expired. As such, concurrent with today's 10-Q filing, the Company also filed a new shelf registration with the SEC.

With that I will now turn the call back to John Thero. John.

Thank you Aaron and Mike. Regarding REDUCE-IT, we now have over 7,000 of the targeted 8,000 patients enrolled. It is important to note that we remain scientifically committed to the REDUCE-IT trial. And thus far we have not made any change to the progress or design of REDUCE-IT as a result of the FDA's unwillingness thus far to approve the ANCHOR indication. However, as previously discussed, if we do not receive approval for the ANCHOR indication, we will be forced to reconsider whether to continue the REDUCE-IT study in its current form.

We continued to pursue FDA approval of label expansion for Vascepa for the ANCHOR indication, with an effort that includes continuing to appeal the FDA rescission of our ANCHOR SPA agreement and working towards label expansion for both an ANCHOR indication and ANCHOR data in the label.

With respect to the status of our appeal, we previously expected, based on FDA's dispute resolution timing guidance, that we would receive a determination from the FDA's Office of New Drugs in late July or early August. However, we were recently notified by the FDA that they require additional time prior to providing us with a determination. Based upon our communications with the FDA, we now anticipate a substantive response to our appeal to Dr. Jenkins in the Office of New Drugs by mid-September.

Dr. Jenkins informed us that before reaching a determination on our appeal, he has opted to seek advice from the CDER Medical Policy Council. As you may know, CDER is an acronym for the FDA's Center for Drug Evaluation and Research. The CDER Medical Policy Council, which includes doctors Janet Woodcock and Robert Temple, and other senior FDA officials, provides a senior level forum to establish medical policy to ensure it's implemented in a consistent manner throughout the center.

Given ongoing dialogue with the FDA, we have no further substantive updates on the SPA appeal at this time. We repeat that while we believe that approval of the ANCHOR indication is in the best interests of patient care in that we have strong legal, regulatory and clinical arguments for reinstating the SPA for the ANCHOR indication, existing levels within the FDA have not agreed. And there can be no assurance that the pending response from the FDA will be any different. We continue to see this effort as an uphill battle.

We know that the FDA is aware of the two genetic studies published in the New England Journal of Medicine in June. We do not know if those studies will have a meaningful impact on the FDA's evaluation of the ANCHOR indication.

For those of you who are not aware of those genetic studies, one was conducted by a group in Denmark and the other was independently conducted by a US-led multinational group. Both studies suggested there is a correlation between reduced triglyceride levels and reduced cardiovascular risk based on patients with genetic traits that cause individuals to have low triglyceride levels. Interestingly, genetic studies have shown a similar link for LDL cholesterol and cardiovascular health, but have not shown a correlation for HDL cholesterol.

As we've discussed, Amarin is making progress on many fronts operationally and financially. We are pleased that the unique profile of Vascepa is resulting in its increased prescription levels and we look forward to the contribution that Kowa is expected to make from its recently commenced promotion of Vascepa. We believe in Vascepa, both for its current indication and for its potential to positively support health concerns of broader indications. We will continue to push for expanded use of Vascepa based upon its already presented favorable results of the MARINE and ANCHOR studies.

With that, I would like to open the line to some questions. Operator?

Thank you. (Operator Instructions). Yi Chen, Aegis Capital.

Hi. Thank you for taking my question. I'd like to know whether you have a plan to invoke the First Amendment in marketing or promoting Vascepa off-label for treatment of mixed dyslipidemia.

So I thank you for the question. I know this is a busy time of year and earnings season, and we're competing with I guess several calls tonight so I appreciate your question. Yes, right now we're pursuing avenues with the FDA and we feel as though we need to exhaust those avenues before we can consider other alternatives. If we do not receive a more favorable decision from the FDA, we will consider other alternatives and, as we've expressed in the past, one of those possibilities is the First Amendment, but we need to exhaust our possibilities with the FDA first.

Thanks. Second question is could you give us some color regarding how much Amarin has paid to Kowa under the co-promotion?

Our royalty under that agreement is in the single digits here. In the first year I think some of the analysts have estimated it to be in the 7% to 9% range of revenues. They came on in the middle of the second quarter so it's not a whole lot that we've paid to them at this juncture. And it's a percent and I give you that percentage, it's off of gross margin as opposed to off of revenues, so it's a lower percentage if you calculate it off of revenue. So really, while we are very pleased with the enthusiasm and getting out and making calls on their accounts, they're just getting started so the [co-op] impact from them in the second quarter, as expected, was fairly limited.

Thank you.

Heather Roberts, 11.11 Capital.

Hi. Would you raise money at current levels with your $300m shelf that you just filed?

So concurrent with today's 10-Q filing, we did file a shelf registration statement. We had had a shelf registration statement in place for the last three years. It recently expired. On our last quarterly investor call, we had indicated that we planned to replace that shelf. There wasn't a particular rush to do that so we did it here concurrently with the 10-Q.

Our primary goals for this year were and remain to increase revenues based upon our current indication, to pursue expanded indication for Vascepa and to preserve our cash. We think that we're executing on all three of those at this point in time. I've been on record for many years talking about it being good governance to have a shelf registration statement in place for any public company. And our filing of that shelf today is consistent with that prior guidance.

Thank you.

Jon LeCroy, MKM Partners.

Thanks for taking my call. So you've had some time now to think about what you guys will do with the ANCHOR program �- I'm sorry, the REDUCE-IT program if the FDA does reject your appeal. Can you talk a little bit about what you're planning on that?

So you are correct that we've had a lot of time to think about it. We are still waiting for a response from the policy level within the FDA, as described in this call. We don't have that response yet and it's being considered at an even higher level within the agency. Until we hear that response it's impossible for us to formalize our decision relative to the REDUCE-IT study.

We remain scientifically committed to the study. We think it's important for patient care. We think that the trial represents a very significant potential opportunity for Amarin shareholders. We think that the trial is positioned to be successful. But it has a lot of costs remaining to it and it needs to be clear to us that if we are to continue this study in its current form that it will result in appropriate approvals based upon the success of that study.

And until we've had further clarity from the policy level within the FDA, we're holding off on making a decision there. The choices are -- the choices range everything from continuing the study in its current form, to stopping the study to modifying the study in some way that potentially, for example, could lead to a result perhaps earlier. But amongst that spectrum, which is quite broad, we aren't going to make that decision until we have greater clarity from the FDA.

Okay. Thanks. And then can you just briefly run through the Paragraph IV filings you guys received and where those stand?

I'll ask Joe Kennedy, our General Counsel, to weigh in on that one. Joe.

Sure. We're at the early stages of the Paragraph IV litigation related to potential generic competition for Vascepa. That process is a process that plays out over years and we're not yet at a stage where we've seen anything that troubles us in any shape or form. I remind the group that we have about 40 patents now that cover Vascepa in its various uses and those are patents that have gone through a long patent prosecution effort with the US PTO that many of you have paid attention to during that process and we feel very good about those patents.

And so we look forward to litigating those patents and seeing that litigation progress. And of course anyone who is interested in following that litigation is welcome to follow that litigation through the public filing system with the US court system.

And so have you filed a suit against anyone filing a Paragraph IV?

We have filed a suit against everyone who has filed a Paragraph IV.

Okay. And then is there a 30-months stay date or is the FDA not -- has it not gone that far yet?

So the 30-month stay date, as we disclosed in our last quarterly filing, is in September 2015.

Okay. Thank you.

[David Yucall], [Bandwidth Capital].

Yes, two questions. Have you predicted what your sales have to go to, to breakeven?

We have not given guidance on that at this juncture. There's too many variables involved, including the conduct of the REDUCE-IT study, for example.

And while if your ANCHOR study doesn't go through and you decide to pull out of the REDUCE-IT study, does your burn drop in half?

We are currently spending on the REDUCE-IT study between $30m and $40m per year. That's during the enrolment phase of the study. And it does vary obviously from quarter to quarter. Were we to curtail the REDUCE-IT study, that number obviously is savings, not immediately, but would be savings as the trial would wind down. As to whether that represents -- what fraction of our expenses that represents, I'll let you calculate.

Thank you. And ladies and gentlemen, there are no further questions at this time. I will turn the conference back to management for closing remarks. Thank you.

Thank you everybody for joining us here today. We appreciate the interest and support and we look forward to further updates with you as we progress this year. Thank you and good day.

Thank you. All parties may disconnect. Have a great day.