Axsome Therapeutics, Inc. Q3 FY2021 Earnings Call

Good day, and thank you for standing by. Welcome to the Axsome Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. I would now like to hand the conference over to your speaker today, Mark Jacobson, Chief Operating Officer. Please go ahead.

Thank you, operator. Good morning, and thank you all for joining us on today's conference call. Our earnings press release, providing a corporate update and details on the company's financial results for the third quarter of 2021, crossed the wire a short time ago and is available on our website at axsome.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of our investigational agent; our clinical and non-clinical plans; our plans to present or report additional data; the anticipated conduct and the scope of future clinical trials; regulatory plans; future research and development plans; commercial plans and possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date, and the company disclaims any obligation to update such statements. Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; Dr. Kevin Laliberte, Executive Vice President, Product Strategy; Lori Englebert, Senior Vice President of Commercial and Business Development; and Dr. Amanda Jones, Senior Vice President of Clinical Development. Herriot will first provide an overview of the company and then review recent developments and upcoming milestones. Following Herriot, Lori will provide a commercial update, and then Nick will review our financial results. We will then open the line for questions. Questions will be taken in the order they are received. And with that, I will turn the call over to Herriot.

Thank you, Mark. Good morning, everyone. And thank you all for joining Axsome Therapeutics' third quarter 2021 financial results and business update conference call. Over the past several months, we have continued to advance our differentiated late-stage CNS product candidates aimed at meaningfully improving the lives of patients. I will provide an update on our development pipeline before turning it to Lori, who will provide a commercial update. Starting with our first lead product candidate, AXS-05, which is undergoing an NDA review for the treatment of major depressive disorder. The FDA did not take action on the NDA by the August 22 PDUFA date as previously disclosed, and a review of the application is ongoing. The agency recently informed us of two deficiencies related to analytical methods in the chemistry, manufacturing and controls section of the NDA, which must be addressed prior to the FDA taking action on the NDA. We believe these deficiencies are addressable and are confirming the details of the request with the FDA. AXS-05 is also being developed for the treatment of Alzheimer's disease agitation. Enrollment in the Phase III ACCORD trial for that indication is progressing. Based on current enrollment trends, we anticipate completion of the trial in the first half of 2023. With regard to the development of AXS-05 in smoking cessation, we received positive pre-IND meeting written guidance from the FDA on a proposed clinical development plan. Based on this feedback, we plan to proceed to a pivotal Phase II/III trial in this indication and expect to provide timing on initiation of that trial next year. Moving on to our second lead product candidate, AXS-07, a multi-mechanistic acute treatment for migraine. The NDA for AXS-07 was accepted for review by the FDA, with a PDUFA target action date of April 30, 2022. The FDA has also informed us that due to COVID-19 pandemic-related travel restrictions, they may be unable to complete an inspection of one of the AXS-07 manufacturing facilities prior to the PDUFA date. They will continue to monitor the public health situation, as well as travel restrictions, and we will keep you informed of any developments on this front. With two NDAs under active review, Axsome is in a position to potentially commercialize two new treatments in the near to intermediate term for patients living with depression and migraine. Lori will provide details on our commercial launch readiness for AXS-05 and our prelaunch commercial activities for AXS-07. The rest of our rich pipeline continues to advance. For AXS-12, our product candidate being developed for the treatment of narcolepsy, we initiated a SYMPHONY Phase III trial in the third quarter. Enrollment in the trial is progressing, and topline results are anticipated in the first half of 2023. For AXS-14, our product candidate for the treatment of fibromyalgia, manufacturing and other activities related to the planned submission of an NDA are ongoing. Based on the status of these activities, we now expect to submit the NDA in 2023. I will now turn the call over to Lori, who will provide a commercial update.

Thank you, Herriot. And good morning. Today, I will give you an update on our commercial activity as it relates to launch readiness for AXS-05 and prelaunch activities that are progressing for AXS-07. As Herriot stated, the commercial team has been actively preparing for the potential launch of AXS-05 and we remain incredibly excited about the opportunity to bring this product to market for the millions of patients suffering from depression. We are ready and prepared should we receive approval. The U.S. remains in the middle of a mental health crisis. Multiple studies have been released recently, noting dramatic increases in depression due to the COVID-19 pandemic. Most recently, a global study published in The Lancet showed that worldwide rates of depression climbed by 28% in 2020, showcasing a devastating ripple effect of the pandemic. Awareness of mental health issues is at an all-time high, and people are talking about mental health today more than ever. Given the personal and economic burden associated with mental health conditions, there is an undeniably urgent need to bring support to those affected. If approved, AXS-05 would be an important new treatment option for the many Americans living with depression. We are prepared and ready to bring this meaningful innovation to patients by commercializing the product soon after a potential approval. Our commercial launch strategy is innovative and purposeful with the intent to bring important new products to market in a meaningful way. We have undertaken great efforts to understand the needs of patients and the health care professionals who treat them. This information has informed our strategy. Our digital-centric commercialization or DCC technology-enabled platform, designed to increase efficiency and effectiveness of our marketing efforts, is fully implemented, tested and ready for execution. As a reminder, we have designed our DCC platform to streamline systems and digital enablement tools, combined with sophisticated data and analytics, to allow for a more effective, efficient and meaningful engagement with physicians and patients. Last quarter, I stated that our impressive field leadership team was fully staffed. Over the past several months, they have been working hard on recruiting top talent to staff our field representative positions. At this time, we have offers formally accepted for a complete sales force team. All offers are contingent upon approval. In the event of a potential approval, we anticipate having all sales representatives on board, trained and certified by launch. Our highly capable and experienced market access team continues to engage with payers in ongoing permitted discussions, ensuring awareness of Axsome, our pipeline and the clinical profile of AXS-05. We look forward to engaging with payers immediately after approval. Our marketing and patient support services teams have been working hard to ensure that our comprehensive patient support services and all marketing materials are complete, implemented and ready for execution in anticipation of a potential approval. Our launch readiness preparations have been heavily focused on AXS-05. However, we are also actively preparing for a potential subsequent launch of AXS-07 for the acute treatment of migraine, a debilitating disease that continues to have a tremendous unmet need and impacts an estimated 37 million U.S. adults. Marketing activities are well underway, along with DCC integration and initiating AXS-07 permitted payer discussions. We are enthusiastic about the potential opportunity that AXS-07 could bring to a market that still sees close to a 70% dissatisfaction rate with currently available therapies. The differentiated clinical profiles for both AXS-05 and AXS-07 have the potential to bring significant benefit to patients and the physicians who treat them. We are excited about the opportunity to potentially bring these important new products to market in an innovative and meaningful way. I will now turn it over to Nick, who will review our financials.

Thank you, Lori. And good morning, everyone. Today, I will discuss our third quarter 2021 results and provide some financial guidance. We ended the third quarter with approximately $115 million in cash compared to roughly $141 million at the end of the second quarter, a net decrease of approximately $26 million. Research and development expenses were $13.2 million for the quarter ending September 30, 2021 versus $14.8 million for the comparable period in 2020. The decrease in R&D expense was driven by the completion of NDA-enabling clinical trials that were ongoing in the prior comparable period. General and administrative expenses were $20.2 million for the quarter ending September 30, 2021 and $6.3 million for the comparable period in 2020. The increase was primarily related to pre-commercial activities and personnel expense, along with an increase in non-cash stock compensation expense. Net loss was $34.9 million or $0.93 per share for the quarter ended September 30, 2021 compared to a net loss of $22.9 million or $0.61 per share for the comparable period in 2020. We recently announced that we have expanded our term loan facility with Hercules Capital to $300 million with $100 million now available upon FDA approval of AXS-05 in MDD and access to an additional $150 million thereafter. This committed non-dilutive capital gives us additional financial flexibility through both anticipated potential commercial launches for AXS-05 and AXS-07. We believe our current cash position of $115 million, along with the remaining committed capital from our $300 million term loan facility, is sufficient to fund our anticipated operations based on our current operating plan into at least 2024. That concludes our third quarter 2021 financial review. I will now turn the call back to Mark to lead the Q&A discussion.

Thank you, Nick. Operator, may we please have our first question?

Your first question comes from Charles Duncan of Cantor Fitzgerald.

Yes, good morning. Thanks, Herriot and team, for the update and for taking our question. Regarding AXS-05 and the analytical deficiencies that were mentioned, I'm wondering if you could provide a little more color on that in terms of what would be expected to be able to address the deficiencies. Are there any additional clinical or non-clinical experiments that you need to run or do you think that you'll be able to address these with the information that you have on hand? And if so, what kind of timing are we looking at? Is it months or quarters?

Thanks, Charles, for the question. I'll turn it over to Kevin to answer that question.

Great. Many thanks for the question. We are actively working on the updates to the analytical methods that the FDA has requested, but we are still in communication with the FDA to fully understand the specifics and the process to resolve the items that they brought to our attention. I will note that these requests are manufacturing-specific based on what we understand right now. So it would be solely resolved from a manufacturing point of view, based on what we understand from the agency at this time. We expect our work to be complete on those methods in the near to intermediate term for resolution.

Okay. That's helpful. So you don't anticipate it impacting any ongoing studies with the product candidate?

We would not anticipate that that would have an impact on any ongoing studies.

Okay, super. And then my second question is maybe for Herriot or someone on the team to speak philosophically about the treatment landscape in MDD. Lori mentioned the challenges of mental health and how awareness has really increased. When you think about the daily chronic therapy paradigm historically versus, say, an intermittent treatment paradigm for more highly burdened patients, how do you think about that relative to AXS-05 and its role in the future treatment landscape?

We're excited about the potential role of AXS-05 in the treatment landscape because, as you know, the current treatment landscape leaves the vast majority of patients with inadequate responses. That is in terms of not just clinical response, meaning a reduction of 50% of symptoms, but also remission. If you look at those parameters and the studies that we have conducted with AXS-05 — multiple studies, both controlled as well as open-label in various patient populations — the product demonstrates the potential to meaningfully impact the treatment landscape and improve rates of remission as well as clinical response. We're really excited about that. As a reminder, the breadth of the types of patients that we have studied spans the gamut from treatment-naïve patients who have never been treated with an antidepressant to patients with treatment-resistant depression who have had multiple lines of treatment. The product so far appears to perform across those lines of treatment. Another notable aspect is the mechanism of action, which we think is contributing to the clinical benefit that we're seeing. As a company, we're excited to be developing a product that is needed by a large percentage of the population and which is timely given the impact of the mental health pandemic on the increased incidence of depression.

Sure, Charles. I always enjoy discussing these topics. Based on an extensive number of discussions with HCPs and the market research we perform, there is an undeniable need for a rapid onset of action in these patients. But physicians do not lose sight of the fact that rapid onset only gets you part of the way. What physicians are really concerned about is remission and durability. Given that our product has shown durability across several studies, we believe that will bode well for us.

Very good. Thanks for the added color. Look forward to the update on the analytical methods. Good day.

Your next question comes from Joseph Thome with Cowen and Company.

Hi there. Good morning and thank you for taking our questions. Maybe the first one, on the deficiencies: are these the only deficiencies that spurred the earlier letter? Or were there other deficiencies that you have since resolved with the FDA that you're aware of? And then second, on the MERIT TRD data, should AXS-05 be approved and launched, how can you best leverage some of these resistant and refractory patient data sets given that the co-label is going to be for MDD? Thank you.

Thanks for the question, Joseph. With regard to the deficiencies that we disclosed today, these are the only deficiencies that we have been made aware of. We are working with the FDA to get clarity on the exact response. That said, this does not mean that these are the only deficiencies that the FDA could request during the review — there could be more or these could be the only ones. We're not making any predictions. Regarding the TRD data that we generated, not just in the MERIT study but in other clinical trials, the indication that we have applied for and that is under review is MDD, so that's the indication. The additional data that we've generated will inform physicians and other health care professionals, because they see all kinds of patients, and it will be up to them to make decisions about how best to treat those patients. We're trying to answer practical questions about how the product may perform once available, but to be clear, the focus is the MDD indication, which is broad and encompasses a wide range of patients with MDD.

Great. Thank you.

Your next question comes from Vamil Divan with Mizuho Securities.

Great. Thanks so much for the call and for taking my questions. One more around the deficiencies the FDA mentioned: can you clarify when you found out about these? It seems like an unusual process as opposed to maybe getting a formal CRL and responding that way. Do you have any insights on why you ended up in this path? Then second, on the agitation trial, it looks like you shifted the timing a little bit. Can you give an update on exactly how far you are into enrollment in that trial and anything that has changed in terms of why the timing is taking a bit longer to complete than you previously thought? Thank you.

Thanks, Vamil. I'll start by answering the first part. In terms of the timing of when we got the communication from the FDA on these deficiencies, we recently received them at the end of October and since then we've been trying to get details so that we can respond specifically. Regarding the characterization of the process, while this is a unique situation, it is not unusual for the FDA to request additional information during an NDA review, whether in any discipline, including CMC. We do not view the information request itself as unusual. I'll turn the question about the agitation trial over to Amanda to provide color on the trial and how the design affects enrollment trends.

Great, thanks. Yes, regarding the agitation trial, this is a randomized withdrawal study, so it's a two-period study where patients are enrolled and randomized and then the trial completion is contingent upon a number of relapses occurring. Based on those variables, and how we track the study, we are anticipating the study to complete in the first half of 2023. It's a slightly complex study design, which involves different metrics related to enrollment and relapses that determine timing.

Okay. Thank you.

Your next question comes from Ram Selvaraju of H.C. Wainwright.

Thanks so much for taking my questions. To follow up, do you have clarity on whether the FDA is going to issue a CRL at some point on AXS-05? Or do you think the currently outstanding matters can be resolved without a CRL being issued? If a CRL were issued given what you currently know about the deficiencies, what would you expect resubmission of the NDA for AXS-05 to be classified as, Class I or Class II?

Thank you, Ram. Regarding whether a CRL will be issued, that would be an FDA action, and we do not determine that. The FDA has stated that these deficiencies related to analytical methods must be addressed before they can take action. An action on the NDA will come in two forms: either an approval or a CRL. The FDA has asked us to provide the information to resolve the deficiencies that must be addressed prior to them taking one of those actions. We are working to understand exactly what needs to go into that response and will do so expeditiously.

So to clarify, it remains possible that when you submit this information to the FDA, the agency may decide not to issue a CRL. Is that correct?

The reason I'm cautious is that the agency has not yet taken action on the NDA — they have neither approved nor issued a CRL. Before they make that decision, they have indicated they would like the information they requested. We are working to provide that information.

On the CMC information being requested: does this pertain to further characterization of the product as opposed to any change in the product itself? Would this affect ongoing clinical studies or require any future bridging work?

That is correct. The information relates to analytical methods and does not require changes to the product itself. It would not affect ongoing clinical studies nor require additional bridging work for other indications.

Thank you. Regarding the smoking cessation clinical program: have you received specific design parameters from the FDA regarding long-term follow-up and evidence of impact on smoking cessation, or does that remain to be determined?

The purpose of the pre-IND guidance was to obtain the agency's input on an entire clinical development plan for AXS-05 in smoking cessation — including the design of pivotal trials and the overall safety database. Coming out of that process, we do have clear guidance, which is why we stated we can proceed into a pivotal trial. We also believe we can leverage existing AXS-05 data, including long-term safety data. The Phase II/III trial would be one of the pivotal studies, and based on guidance, we believe two studies would be needed in the indication. We plan to provide timing on initiation of that trial next year.

And to clarify, the pre-IND guidance means that if the Phase II/III trial is positive, it could support a filing for approval in smoking cessation? Also, could that trial yield data before the end of 2022 or is it more likely a 2023 event?

The guidance supports proceeding to pivotal trials. Regarding timing, we will provide further guidance on the initiation timing next year. We have many programs ongoing and are scaling our capabilities to take advantage of multiple opportunities. The Phase II/III trial will be pivotal, but we are not committing to exact start or readout timing until next year.

Your next question comes from Joon Lee of Truist Securities.

Thanks for the updates. You mentioned that deficiencies could be resolved near to midterm. Can you define what that means — weeks, months, or quarters? Also, you stated that all offers have been made for the sales force but are contingent upon approval. Is there an expiration date on those offers?

I'll let Lori take the second question on offers.

The current offers are being considered through June. Depending on additional clarity from the FDA, we'll determine how to leverage the offers that are outstanding. The field candidates we've extended offers to are of high caliber, and we would like to retain them, but we need additional clarity on timing from the FDA before making a final decision.

Regarding near to midterm, that refers to weeks to months and will depend on further feedback from the FDA, which we are awaiting.

Will you press release once you have submitted those responses to the deficiencies?

We want to provide as much information as we can to investors given the unique situation, but we also need to balance that with the fact that the review is ongoing. Historically, we have not provided play-by-play details of back-and-forth with the agency during review because it is a fluid process. We intend to update the market on any definitive developments, but do not expect to provide a detailed running commentary.

Your next question comes from Marc Goodman of SVB Leerink.

Hi, Herriot. A couple of questions. If you think simplistically about an NDA with three sections — CMC, safety and efficacy — has the FDA signed off on the safety and efficacy portions, or do you not have those signed off yet?

If you think simplistically, I agree those are the main sections, but the process is not a simple one. The FDA reviews the NDA and may ask sponsors for information as part of its review. Right now, the information requested relates to CMC, and that is what we are responding to. We have not received notice from the FDA of other deficiencies in other disciplines.

Has there been interaction back and forth with the FDA on the safety data and efficacy data?

Yes, the FDA has been reviewing the application and there has been interaction across all disciplines of the NDA, as one would expect given the stage of review.

Regarding the CMC section: I thought CMC was okay. What came out that surprised us? Also, you said you're still trying to figure out exactly what the FDA needs. How can you feel comfortable saying it's weeks to months if you're still not sure what they need?

We indicated weeks to months to complete the work that we need to perform. That depends on the specificity we receive from the FDA and then the actual experiments or method updates required. Regarding the CMC review, the review is ongoing. As part of the ongoing review, it's typical for sponsors to receive information requests along the way. The timing and nature of such requests can vary with the reviewer and the rhythm of the review. Our job is to respond appropriately, which is what we're doing.

Can you help characterize what these two deficiencies are a little better? Is it an analytical method demonstrating that manufacturing is as good as it needs to be? What exactly are you talking about?

Analytical methods relate to testing of the finished drug product, our tablets. This does not relate to the manufacturing process itself. Analytical methods can be adjusted in sensitivity or range. We believe our process is robust and that these are addressable items that we can resolve.

Thanks. One quick question on migraine: did you say that one of the two manufacturing sites might not be inspected by the PDUFA date? Is one inspection enough or are both required?

Thanks for that question. There are multiple manufacturing sites involved in the process for AXS-07. The FDA notified us that one specific manufacturing location based in the United States is required to have an inspection as part of the review. They also notified us that because of COVID-related travel restrictions, that inspection may be in jeopardy of occurring before the PDUFA date. So it is this one U.S.-based manufacturer they specifically identified.

Thank you.

Your next question comes from Vikram Purohit of Morgan Stanley.

Great, good morning. Thanks for taking our questions. Two from our side. First, going back to AXS-05 for MDD: can you clarify next steps? Have you submitted clarification questions to the agency and are you waiting to hear back, or are you preparing a submission in response to the initial feedback which could take weeks to months? Second, on AXS-14 and fibromyalgia, your release mentioned NDA submission is expected in 2023. What needs to happen between now and then to enable a filing?

Yes. We have submitted clarification questions to the agency because we want to ensure that when we respond, the response is accurate and addresses exactly what they need. We do not want to rush to submit a response that may not be sufficient. Regarding AXS-14, the primary activities remaining are CMC and manufacturing. AXS-14 is a new chemical entity, so we must synthesize material and generate stability data. Most of the rate-determining work to file the NDA relates to manufacturing.

Okay, got it. Thank you.

Your next question comes from Ashwani Verma of Bank of America.

Hi. Thanks for taking our questions. I wanted to understand: can you give some confidence that your team or any external partners will be able to navigate through this? Has your team or regulatory consultants handled such a situation before? Second, on the analytical method, would you need to redo experiments or does this just need to be characterized better — would anything need to be redone?

We are working to get clarity from the FDA and that is exactly what we are doing. We believe the deficiencies are addressable and we are confident in our ability to address them. This type of request is not unusual during NDA review; the reason we're discussing it now is that we are past the original PDUFA date and want to keep stakeholders informed. The exact experiments or updates will be determined once we have specifics from the FDA.

A quick follow-up: the field force build is complete — how many reps are we talking? Are you focused on prior dextromethorphan prescribers or other prescriber segments?

I'll speak to the size of the sales force at the time of launch; I don't want to disclose the exact number right now. But I will say we plan to personally promote to what we believe will be 85% of the high-value prescribers in the marketplace. That will cover greater than 25,000 HCPs on a personal promotion basis, and additional HCPs will be targeted via non-personal promotion.

Got it. Thank you.

Your next question comes from Matt Kaplan of Ladenburg Thalmann.

Hi. Thanks for taking the question. Regarding the deficiencies and this unusual process: could your answers be deemed a major amendment and would the FDA issue a new PDUFA date? Or will you proceed without a new action date?

When the FDA misses a PDUFA date, there is no new PDUFA date automatically established. We will work with the agency to provide the requested information and await their action.

That's helpful. Second, on commercial preparation: what's your sense from potential payers about coverage and pricing?

We have had permitted payer discussions since around April, and feedback has been encouraging. We will not engage in formal pricing discussions until after approval and we have a final label. Our goal is to ensure patients receive access while capturing appropriate value for the product.

Thanks for taking my questions.

Your next question comes from Yatin Suneja of Guggenheim.

Hi. A couple of questions: could you enter into labeling discussion prior to addressing these deficiencies? Or, if the FDA is okay with the clinical section, could you enter labeling discussions earlier? Also, are you sure there is no physical inspection required at this point?

The deficiencies with regard to CMC have not been characterized by the agency as ones that would preclude labeling discussions. We will not comment on the timing of labeling discussions, but these deficiencies were not described as precluding them. Regarding inspections, we have not been made aware of inspections that need to be completed prior to approval for AXS-05.

One more: any color on payer discussions and comps for pricing modeling?

As mentioned, permitted payer discussions have been encouraging. We will not engage in formal pricing conversations until after approval and a final label. Payers recognize the unmet need and the novel mechanism of action; our approach will be to ensure access while capturing the product's value, and we will announce pricing at approval.

We do have time for two more questioners. Your next question comes from Myles Minter of William Blair.

Hi, thanks. I might have missed it, but did you say that the deficiencies discussed today do not preclude labeling discussions?

That is correct.

So the letter you received that stated deficiencies that did preclude labeling discussions — either they still exist or you're currently in labeling discussions? Could you clarify?

We disclosed the prior letter and have now disclosed additional information on deficiencies. We do not know if the current deficiencies are the same as those previously referenced or whether they are new. This is the information we have and we are providing it to you as we receive it. As a sponsor, we welcome the opportunity to address the FDA's questions to aid the review process.

Final one: does the NDA filing for AXS-07 carry the same analytical measures on the manufacturing level as 05 in the current filing?

Because the products are distinct molecules with different active components, the analytical methods would not necessarily carry over into the AXS-07 application.

Cool. Thanks, guys.

Your next question comes from Joon Lee of Truist Securities.

Thanks for taking my follow-up. I've been getting questions from investors: when you say the analytical method relates to further characterization of the product but not the product itself, can you clarify that? How can you be confident this is not related to the product itself? Also, you got the letter from the FDA about the deficiencies in August, but the nature of the deficiencies was not disclosed until late October. Is that correct?

When I said the analytical methods do not relate to the product itself, I meant the distinction between the manufacturing process and the analytical methods that test the finished goods. The analytical methods test the finished product — in our case the tablets — and are distinct from how the tablets are manufactured. Regarding timing, the characterization you described is correct.

I will now turn the conference back over to the CEO.

Well, thank you again, everyone, for joining us on the call today. With four pipeline candidates being developed in six indications, which are either under FDA review, filing, or in development, we believe that we have built the leading CNS-focused pipeline in the industry. We're working hard to bring these potentially life-changing medicines to people who live with serious CNS conditions. We look forward to keeping you updated on our continued progress. Have a great day.

Thank you for participating in today's conference call. You may now disconnect.