Earnings Labs

PAVmed Inc. (PAVM)

Q1 2019 Earnings Call· Tue, May 21, 2019

$8.85

+5.36%

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Transcript

Operator

Operator

Greetings, and welcome to the PAVmed Inc. Business Update 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] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mike Havrilla, Director of Investor Relations for PAVmed. Please go ahead, sir.

Mike Havrilla

Analyst

Good afternoon, everyone. This is Mike Havrilla, PAVmed's Director of Investor Relations. Thank you all for participating in today's business update conference call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer; and Dennis McGrath, President and Chief Financial Officer. Before we begin, I'd like to caution the comments made during this conference call by management will contain forward-looking statements regarding operations and future results of PAVmed. I encourage you to review the company's filings with the Securities and Exchange Commission to identify specific factors which may cause actual results or events to differ materially from those described in the forward-looking statements. Factors that may affect the company's results include, but are not limited to, the uncertainties inherent in research and development, including the costs and time required to advance products to regulatory submission; whether and when products are cleared by regulatory authorities; market acceptance of products once cleared and commercialized; company's ability to raise additional capital; and the competitive environment. PAVmed has not yet received clearance from the FDA or other regulatory bodies to market any of it's products; new risks and uncertainties may arise from time-to-time, and are difficult to predict. All of these factors are difficult or impossible to predict accurately, many of them are beyond the company's control. For a further list and description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A entitled Risk Factors in PAVmed's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, and any subsequent updates filed in Quarterly Reports on Form 10-Q. Except as required by law, PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions or circumstances on which those expectations maybe based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. With that said, I would like to turn the call over to Lishan Aklog. Dr. Aklog?

Lishan Aklog

Analyst

Thank you, Mike. Good afternoon, everyone and thanks for joining us on this quarterly call to discuss -- to update you on our business and discuss our recent financial results. We are so fortunate have engaged shareholders who share a long-term commitment to our vision here at PAVmed. I'd like to thank all of our shareholders, especially our long-term shareholders and new shareholders for their ongoing support. We remain firmly committed to providing you with timely and robust communications on our progress. As a reminder, the best way to keep up with PAVmed news, updates and events is to sign up for our email newsletter and to follow us on Twitter, LinkedIn, YouTube, and on our website. As I stated in this morning's press release, the 4.5 months of the -- for the first 4.5 months of this year represent perhaps the most exciting period in our company's history with enormous amount of hardwork and perseverance coming to fruition on multiple fronts. These include a critical clinical milestone for CarpX, solid regulatory and reimbursement progress with EsoGuard and EsoCheck, the successful completion of important animal studies for PortIO and DisappEAR, exciting technological breakthroughs for Exelon PortIO, palpable [ph] enthusiasm for EsoGuard and EsoCheck during the major Annual GI Conference, and even some important patent allowances from the USPTO. Before Dennis provides an overview of our first quarter results, I'd like to spend the bulk of today's update on the lead products and including our portfolio, CarpX, EsoGuard and EsoCheck. These products collectively target unmet needs in millions of patients worldwide and multi-billion dollar addressable market opportunities that are central to our mission to build a valuable high growth commercial company. Here are some of the highlights that are specifically related to these key products; we successfully treated the first nine…

Dennis McGrath

Analyst

Thanks, Lishan and good afternoon, everyone. I'll be brief as our financial results for the quarter-ended March 31, 2019 were reported to the SEC on Form 10-Q this past week, and our related press release was published this morning. The Form 10-Q is available at sec.gov and on our website where we also have posted the press release. So with regard to the financial results, our research and development expense for the first quarter of 2019 were $1.45 million, about $80,000 than the fourth quarter. Consistent with the remarks we made last quarter through the end of this current quarter, R&D increased as we pushed CarpX and EsoCheck towards FDA clearance, PortIO and DisappEAR completing their animal studies, as well as milestone breakthroughs for NextFlo as Lishan explained. Third-party contract development and manufacturing expenses accounted for nearly 75% of our year-over-year increase which was around $890,000. General and administrative expenses were $1.7 million for the first quarter of 2019 compared with $1.4 million for the same period in 2018, and were lower by about $250,000 sequentially. The increases are due principally to have compensation related costs including increased headcount and stock-based compensation expense, as well as other operating costs, largely related to pre-commercial launch activities including tradeshows, travel and key opinion leader events. PAVmed reported an operating loss for the three months ended March 31, 2019 of $3.1 million, and a GAAP net loss attributable to common stockholders of $3.6 million or a loss of $0.13 per common share. The difference between the two principally reflects changes in the fair value and other related non-cash charges affecting GAAP accounting for the convertible debt and you can look to the 10-Q for a whole lot more detail in regards to that. Our press release and the 10-Q provides substantially more detail related to the non-cash charges occurring in the current and prior periods, as well as the various security exchanges undertaken in the first quarter of last year to mitigate some of those events. Also, the press release provides a table entitled non-GAAP measures, which highlight these amounts along with interest expense and other non-cash charges, which are predominantly depreciation and stock-based compensation, so that the reader might have a better understanding of the company's financial performance. We'll notice from that table that after addressing the GAAP loss by these charges, the company reported non-GAAP adjusted loss for the three months ended March 31, 2019 of $2.5 million, or $0.09 per common share. PAVmed had cash of $4.2 million as of March 31, 2019, which is a change of approximately $4 million during the first quarter. Note, that a significant part of the cash used, namely $1.3 million of the $4 million reflected a reduction of the payables and accrued liabilities. Due where after the quarter ended, we increased cash by $3.7 million which offsets the first quarter burn almost entirely. With that operator, let us open it up for questions from our audience.

Operator

Operator

[Operator Instructions] Our first question comes from the line of Anthony Vendetti with Maxim Group. Please proceed with your question.

Anthony Vendetti

Analyst

Just wanted to follow-up on CarpX first, and that -- so it sounds like the first nine patients went extremely well, no adverse events. From the fourth quarter when we talked about doing the first in human trials, we -- I think discussed doing 20 patients and I know the next group is up. Is the next group the next 11 or is it a smaller group before we get to the 20?

Lishan Aklog

Analyst

Bottom-line is we're confident on the timelines we've outlined. The actual number of patients is sort of approximately 20, it may be more but those patients are being recruited and they are going through the informed consent process and preoperative testing but we're confident that we'll complete enough patients in this next round to get us to -- through those 90 day -- through that 90-day follow-up and then submission of those results according to the schedule we are finding. We're really, fairly close to what we had talked about during our last call.

Anthony Vendetti

Analyst

Okay. So as you mentioned then on the call, Lishan, expectation is assuming this next group goes well that it is still possible to get clearance and to start commercializing it by the end of 2019?

Lishan Aklog

Analyst

Yes, that's correct.

Anthony Vendetti

Analyst

And then, I know you gave a good update on all the other products; is there anything in the timeframe that you have on the other products that has changed from the fourth quarter or as with CarpX, everything else still fairly on-track?

Lishan Aklog

Analyst

I would say things are really on-track. I think the key -- probably of all the things that I mentioned and probably worth highlighting is the fact that we used the pre-submission process with the FDA to get them to sign-off on the substantial equivalents of the data that came out of the animal study. So we did it and we did that in a way that allowed us to preserve some time on the clock which is always helpful to them and I think we'll get that wrapped up very quickly. So that's obviously good news and it's consistent with what we discussed last time and also, it was a good new to all of the gastroenterologists who came by the booth at DDW this week because there is a lot of -- as I mentioned, there is really a lot of excitement around having the opportunity to use this both, for Barrett's as well as first another condition that works for [ph].

Anthony Vendetti

Analyst

And then, as we look ahead through the remainder of this year, is the focus going to be on obviously, going forward with all these products but I know Lishan, you're always thinking of additional products. By the end of the year could there be any other products that we'll start hearing about in terms of what's in the pipeline?

Lishan Aklog

Analyst

Well, I mean I'll just say this which is that it's sort of in the DNA of this company, it's what we were founded on, to always be seeking innovations that fit within our business model and that thing that we believe will be additive to the value creation opportunity within this company and I think I'll use that -- your question to sort of highlight the story of the EsoCheck and EsoGuard technology because if we had been talking sort of Q1 of 2018, these were not even on the radar, we hadn't even been presented this technology, we were offered it in -- to look at it in January of 2018, and exactly a year ago today, this month, we consummated a licensing agreement. So there should be no more -- no stronger evidence that we're always opportunistic, we're always looking for opportunities to identify really attractive [indiscernible] that can add value to this company and I think the EsoGuard, EsoCheck story is a pretty good example of that.

Anthony Vendetti

Analyst

And then Dennis, just on the expense line; the overall expenses came in a little lighter than we were looking for. G&A was down a little bit, and then R&D was up a little up. Are those -- Dennis, are those better numbers to you as in terms of modeling going forward or should we look for something different for the rest of 2019 in terms of the cadence for G&A and R&D?

Dennis McGrath

Analyst

It's a great question because the beauty of this model is the ability to almost have the largest portion of our expenses pretty variable, right; so we can speed them up or slow them down based upon resources and opportunity and as you go through Lishan's remarks, you can see the significant advances that were made -- something like NextFlo, and it made sense to continue to invest behind in DisappEAR and PortIO and the EsoGuard technology is accelerating faster than what we initially anticipated. So the second quarter may very well look a lot like the first quarter and as we get through these heavy duty R&D expenditures to advance all these technology for instance, the New Zealand trial going on in the second quarter, then things will start to modulate depending upon what the next step is for the commercialization of some of these technologies or the outright strategic exit for some of the non-lead products.

Operator

Operator

[Operator Instructions] Our next question comes from the line of Tom [ph]. I apologise, there are no further questions at this time. Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to Dr. Lishan Aklog, CEO, for closing remarks.

Lishan Aklog

Analyst

So, thank you all for joining us this afternoon and for your question, Anthony. We look forward as always to keeping you abreast of our progress via frequent news releases and periodic conference calls such as this one. I also encourage you to contact Mike directly with any questions at jmh@pavmed.com and to contact us on the various social media sites that I had listed earlier. Everyone have a great day. Thank you.

Operator

Operator

This concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation.