electroCore, Inc.
Q4 2019 Earnings Call Transcript

Published: 24 Mar 2020

[Operator:]

Greetings. Welcome to electroCore’s Fourth Quarter and Full Year 2019 Earnings Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded. I would now like to turn the conference over to your host Mr. Hans Vitzthum of LifeSci Advisors. Please go ahead.

[Hans Vitzthum:]

Thank you, operator and thank you all for participating in today’s call. Joining me are Dan Goldberger, Chief Executive Officer and Brian Posner, Chief Financial Officer. Earlier today, electroCore released results for the quarter ended December 31, 2019. A copy of the press release is available on the company’s website.Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the Federal Securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements including, without limitation, our examination of operating trends and our future financial expectations are based upon today’s current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to differ materially from those anticipated or implied by these forward-looking statements. Accordingly you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with the company’s business, please see the company’s filings with the Securities and Exchange Commission.electroCore disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements whether because of new information, future events or otherwise. This conference call contains time-sensitive information that is accurate only as of the live broadcast today, March 23, 2020.And with that, I will turn the call over to Dan.

[Dan Goldberger:]

Thanks Hans. Hello everyone and thank you for joining us today. We are all adjusting to the impact of the COVID-19 pandemic and that has affected our ability to forecast our business and things. I will begin with an operational update before turning the call over to Brian to review our financial results. You will recall that electroCore is in the early stages of commercialization of our proprietary gammaCore therapy for headache patients.Total revenue for the full year 2019 was $2.4 million, a 141% increase from $993,000 in 2018. Of course, we have made substantial changes to our go-to-market strategies over the last year. We have dramatically reduced our efforts to reach patients through commercial channels in favor of two specific opportunities where we are reliably getting paid

[Brian Posner:]

Thanks, Dan. For the quarter ended December 31, 2019, electroCore reported net sales of $675,000 compared to $683,000 in the third quarter of 2019. Revenue in the company’s channels of focus the VA and the United Kingdom increased approximately $200,000 or 45% from third quarter of 2019 levels. This increase was offset by a decrease in revenue from the U.S. commercial channel. The increase in revenue compared to the fourth quarter of 2018 reflects increased sales in the VA and the United Kingdom.Total operating expenses for the fourth quarter of 2019 were approximately $8.9 million compared to $15.9 million in the fourth quarter of 2018. The decrease was due to a reduction in SG&A expense, which declined to approximately $7.3 million in the fourth quarter of 2019 from approximately $12.4 million for the comparable period in 2018 primarily driven by a decrease in compensation and other expenses consistent with the cost reductions implemented in 2019.GAAP net loss from operations for the fourth quarter of 2019 was $8.5 million as compared to a loss of $15.3 million in the fourth quarter of 2018. Adjusted EBITDA from operations for the fourth quarter of 2019 was a loss of $6.7 million, a 54% decrease when compared to adjusted EBITDA net loss from operations of $14.5 million for the same period last year. The company defines adjusted EBITDA from operations as GAAP net loss from operations, excluding income tax expense, stock compensation expense, restructuring and other severance-related charges, legal fees associated with stockholders’ litigation and total other income and expense. A reconciliation of GAAP net loss from operations to non-GAAP adjusted EBITDA net loss from operations has been provided in the financial statement tables included in today’s press release.Now, looking at the full year, for the full year 2019, we generated revenue of $2.4 million as compared to $993,000 for the full year of 2018. The gross profit for the full year 2019 was $1.2 million as compared to $414,000 for the full year of 2018. Total operating expenses were $47.3 million for the full year 2019 as compared to $55 million for the full year of 2018. The decrease in full year operating expenses was due to significant reductions in our cost structure implemented during 2019. GAAP net loss from operations for the full year 2019 was $45.1 million as compared to $55.8 million for the full year 2018. Our adjusted EBITDA loss for the full year was $39 million as compared to $46.9 million for the full year 2018.Cash, cash equivalents and marketable securities at December 31, 2019 totaled $24.1 million as compared to $68.6 million at December 31, 2018. Net cash burn was $9.4 million for the quarter ended December 31, 2019. It should be noted that the December quarter cash burn included several non-recurring items such as previously committed purchase of the inventory as well as severance and fees related to the company’s CEO transition and costs resulting from the company’s 2019 comprehensive redeployment and cost reduction plan.Now, looking ahead, as Dan indicated, we have suspended revenue guidance for 2020. We expect to continue to reduce quarterly research and development expenses throughout 2020. We expect to continue to reduce quarterly SG&A throughout 2020. Our expected cash requirements for 2020 and beyond are based on the commercialization success of our products and our ability to reduce operating expenses. There are significant risks and uncertainties as to our ability to achieve these operating results including as a result of the potential adverse impact on our business from the ongoing COVID-19 pandemic. Due to these risks and uncertainties we may need to reduce activity significantly more than our current operating plan and cash flow projections assumed in order to fund operations to the end of 2020.And now, I will turn the call back over to Dan.

[Dan Goldberger:]

Thank you, Brian. The COVID-19 pandemic has changed our lives and our ability to plan for the coming months. electroCore employees have been asked to work from home effective Monday, March 16, 2020, but we continue to take orders and process shipments from our New Jersey facilities to provide gammaCore therapy to patients in the United States and abroad. gammaCore therapy can be dispensed virtually unlike our pharmaceutical competitors, BOTOX and CGRP antibodies which require an injection by a healthcare professional that may become yet another marketing advantage for non-invasive vagus nerve simulation. I want to take a moment to thank our employees and service providers, our physicians and their patients and our investors for your support during in this uncertain and difficult period. With that, operator, please open the call up for questions.

[Operator:]

Thank you. [Operator Instructions] Our first question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.

[Ryan Zimmerman:]

Great. Dan, Brian, can you guys hear me okay?

[Brian Posner:]

Yes, I can.

[Dan Goldberger:]

Yes. How are you doing, Ryan?

[Ryan Zimmerman:]

Good. I know these are challenging times certainly for a company your size and appreciate all the updates. Maybe Dan just to start, you alluded to potentially using telehealth to treat some of the veterans in their homes, where are you at in terms of setting that up, how long could that potentially take you? That’s – let’s start there. And then I want to ask just in terms of characterizing kind of what you are hearing from headache clinics and clinicians in those channels where you have been successful and how long you are kind of assuming for the impact in terms of modeling the slowdown and appreciate that this is a very fluid situation?

[Dan Goldberger:]

Yes. I will take the last question first. We have no idea when normalcy comes back in terms of patients visiting their physicians in the clinics. Nobody does at this point. But coming back to your opening question the VA system where we have been focusing in the United States has been migrating to telehealth solutions for quite a while, especially for, I’ll call it no more routine therapies like headache, like recurring migraine and certainly for cluster headache. In January, we started shipping our product directly to the patient’s home. And so during the first quarter, we became fully capable of a physician having a telehealth consult with a new patient or a returning patient, physician writes a prescription to the supply chain folks in the VA. They send us a PO and we ship directly to the patient. So for retuning patients they already know how to use the device. For new patients, they can first be prescribed and receive the therapy without having to leave their homes and we have a variety of video support and of course telephone support for those new patients. So call it good planning or call it just-in-time, but we have a fully serviceable telehealth solution for headache patients in the VA system as of January this year and that’s been very, very well received. As far as our run-rate, I alluded to it on the call, but the prescriptions that we are writing, that we are filling in the VA system in the United States and in the UK are on plan. We haven’t seen any drop-off. And so we are nervous about whether things will slow down but right now things are still humming.

[Ryan Zimmerman:]

That’s helpful. And then Brian just one for you, you talked about R&D coming down for the year as well as SG&A coming down for the year and obviously that’s a necessity, but if you can provide anymore color in terms of how rapid can you wrap up Premium 2 to the point where you have very little R&D costs maybe just some color there I think would be helpful for people to think about OpEx for the year?

[Brian Posner:]

Sure, Ryan. No problem. I think running it down now and so I think Q1 will still be lower than Q4 and Q2 will be lower than Q1 and so on and so forth. So R&D it will be coming at a much more manageable level for the company as the year goes on.

[Ryan Zimmerman:]

And any commentary on SG&A?

[Brian Posner:]

Yes, SG&A a function of our SG&A costs have been some of the distribution costs associated with the partners for coverage and those wrapped up pretty much in Q4 from a little bit of spillover in Q1. So we again other ways to sell our products we should see again significant reduction in G&A, SG&A as the year goes on as well, distribution costs but we are also looking at all other costs in the SG&A line.

[Ryan Zimmerman:]

Okay. I appreciate you taking the questions guys.

[Brian Posner:]

Thank you.

[Dan Goldberger:]

Yes, thanks. Stay healthy.

[Operator:]

Our next question comes from the line of Craig Bijou with Cantor Fitzgerald. Please proceed with your question.

[Craig Bijou:]

Good afternoon guys. Thanks for taking the questions. Let me start with maybe just a couple of follow-ups. So for clarification, Dan, so it sounds like you guys I guess let me ask directly, it sounds like I am not sure if you guys are seeing an impact from COVID-19, I know you said that your access has been noted, but I guess I just want to be sure has that shown up in the numbers yet or expecting it to or it’s a possibility. So I just kind of wanted to get that prescription?

[Dan Goldberger:]

Yes. And so – and I am choosing my words carefully here, Craig, but through Friday 20, prescriptions are coming in, in fact last week was a record week for prescriptions in the U.S. So I just look through March 20. We don’t see any impact in paid prescriptions in our business. That said, our sales reps are no longer traveling. The hospitals in the U.S. and in the UK no longer allow vendors to come in and then frankly even patients can’t come into the hospitals. So we are anticipating especially our ability to bring on new patients – new to the therapy we think is we expect is going to be impacted but just looking at the numbers as of last Friday you don’t see it.

[Craig Bijou:]

Got it. Thank you. Thank you for that. Maybe another follow-up on the program to deliver to veterans at home, I mean I guess what do you guys have to do either steps or maybe limitations to transition more of that business to telehealth? Obviously it sounds like you have started in January and it seems like it would be financially advantageous anyway, so maybe just talk about how much you can actually deliver through that pathway and then plans for the rest of the year even beyond the COVID-19 impact?

[Dan Goldberger:]

Yes, good question. So, we have highlighted the program in Florida and California in January and then we accelerated going in and out across the rest of the country, because it was going so well. At this point it’s purely education and making sure that our existing customers know that they have that capability and that we can provide the support directly from electroCore. As we go further into the year we had a variety of marketing programs that we have planned both for awareness of headache patients in the VA system as well as the clinical probes that we have placed all of that and hold to add better visibility on what kind of access we have post virus.

[Craig Bijou:]

Got it. Thanks. And one more and you talked about it a little bit just, but maybe more specific question on the impact of COVID-19 in the UK, I mean, is there any other, I mean, I think you talked about access being denied or restricted. So is there any other ways or channels to sell in the UK?

[Dan Goldberger:]

So, that’s a good question. We have had our success so far through the IITP program and we are loathed to try and tinker with that government funded program since we have had so much success with it. But as we have been experimenting with telehealth in the United States our colleagues in the UK are watching carefully and we maybe able to rollout some of those programs, but probably not this year.

[Craig Bijou:]

Got it. Thanks. Thanks for the color and thanks for taking the questions.

[Operator:]

Our next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Please proceed with your question.

[Swayampakula Ramakanth:]

Thank you. Good evening, Dan and Brian. Hope your families are safe and healthy during these crazy times. I have a couple of questions. In terms of current revenue or in terms of what you have seen so far, is there a way for you to qualitatively give us some kind of a color as to what percent of that revenue comes from returning patients in the sense, because your candidates [ph] electronically in the sense you can just reload the device? So, how -- what percent of that basically comes from that way of doing this?

[Dan Goldberger:]

So, RK, that’s a perfectly reasonable question. Historically, we have not given out data between new prescriptions and refills and so we are just not in a position to do that right here.

[Swayampakula Ramakanth:]

Okay, fair enough. And then say for certain areas where there is no physical access to the physician, what is a typical interaction between a physician and a patient before the script is written in the sense, is it basically face-to-face meeting and the script is written or does the physician have to do some specific lab tests on the patient before the patient has prescribed therapy through the VNS system?

[Dan Goldberger:]

Very good question, RK. So historically, patients that have been offered gammaCore therapy tend to be patients who have been to the headache clinic to the neurologists historically right there. They have some pattern with the physician that’s dealing in care. So they have had previous visits. They have tried other therapies. Going forward, we expect that, that will migrate to new patients being able to gain access to the therapy without a preexisting history, but that’s not what we have experienced so far.

[Swayampakula Ramakanth:]

And then the last question on the same way in terms of the telehealth and whatnot, so how does a physician and a patient think about gammaCore? Do they think it’s quite a bit of an innocuous therapy in the sense, okay, I can bring you in and do all the tests that I would like to do than I before I do have to give you certain medicines, pills or whatever, but this is something that you can try while we are waiting for you to come into the clinic so that I can do other tests to give you a pill? Does that started your work here or does that – has that been employed before?

[Dan Goldberger:]

So, we think that’s going to happen. Many of our most successful patients are those that have been on triptans have had some number of BOTOX treatments and finally get relief when gammaCore therapy is offered to them. Given that access direct access to the physicians is changing we think that gammaCore is going to move up towards first line therapy, because it’s so safe and because it can be delivered virtually and so proof we will see in the next 6 months, but we do think that’s going to happen.

[Swayampakula Ramakanth:]

Thank you. Thank you, Dan and good luck both of you.

[Brian Posner:]

Thank you.

[Dan Goldberger:]

Thank you. Stay healthy.

[Operator:]

[Operator instructions] Our next question comes from the line of Ahu Demir with Noble Capital. Please proceed with your question.

[Ahu Demir:]

Hi Dan. Hi, Brian. Thank you very much for taking my question. My question will also be on the COVID. So do you have enough inventories let’s say the lockdown will continue you won’t be able to manufacture, do you have enough inventory of gammaCore to deliver for the whole year?

[Brian Posner:]

It’s Brian. We have plenty of inventory, plenty of inventory.

[Ahu Demir:]

Okay.

[Dan Goldberger:]

Yes. I think we have $7 million of inventory on the balance sheet I think Brian. Is that the right number?

[Brian Posner:]

Yes, that’s the number that we are reporting about $6.9 million so that’s not something that’s keeping us [indiscernible].

[Ahu Demir:]

Okay. That’s nice to hear. My second question is on the FDA last year that you were supposed to submit early March, is it – I know things are postponed of course but I was just curious thinking actually submitting the letter for the migraine prevention so and is it on track?

[Brian Posner:]

Yes.

[Dan Goldberger:]

Yes. You will recall that the FDA sent us questions we met with the agency at the end of last year and we filed our formal response, it was February 28, February 27, we filed our official response to the FDA questions.

[Ahu Demir:]

So, we are still expecting potential clearance on that in 2020 if things go well?

[Dan Goldberger:]

Yes, who knows what’s – how the agency is staffed these days either, but my expectation is that there will be one more round of questions before we get to a final determination, but it’s very hard to figure out what the calendar looks like.

[Ahu Demir:]

Okay, thank you for that. And my last question is the Doctor LLC Group, what is the revenue on that side for the fourth quarter? Did you actually make any changes on that? Do we expect – moving forward do we expect any adoption or acceleration on that side?

[Dan Goldberger:]

So, short answer is no. Doctors Medical is setup as a distribution agreement. They buy product from us at a transfer price and then sell it into their channel for workers’ comp and personal injury practices. They made an initial purchase of 50 units in the third quarter and they continued to place those units, but I don’t think – I think they have placed less than half of the original order of 50. So we don’t – it’s a good business relationship, but we don’t anticipate any substantial reorders for the rest of the year given the slow pace at which they have been placing their original order.

[Ahu Demir:]

Okay, that’s helpful. Thank you very much. Thanks for taking my questions. I hope you stay safe.

[Dan Goldberger:]

Great. Thank you. Have a good evening.

[Operator:]

Ladies and gentlemen, there seems to be no further questions in the queue. And I would like to turn the call back over to Mr. Dan Goldberger for any closing remarks.

[Dan Goldberger:]

Thank you, operator. Thank you all for making time to hear our story. We are all hoping for the best and planning for survival. So have a good evening everybody.

[Operator:]

This concludes today’s teleconference. You may now disconnect your lines at this time. Thank you for your participation and have a wonderful day.