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Q2 2018 Earnings Call· Tue, Aug 14, 2018

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Transcript

Operator

Operator

Good day, everyone, and welcome to the Precision Therapeutics Q2 2018 Business Update. Today's conference is being recorded. And at this time, I would like to turn the call over to Elizabeth Parker, Investor Relations at KCSA Strategic Communications. Please go ahead.

Elizabeth Parker

Management

Thank you all for participating in today's call to discuss Precision Therapeutics financial results for the second fiscal quarter of 2018. Joining me today are Dr. Carl Schwartz, Chief Executive Officer of Precision Therapeutics; Bob Myers, Chief Financial Officer of Precision Therapeutics; and Gerry Vardzel, Chief Executive Officer of Helomics Corporation. Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements regarding the operations and future results of Precision Therapeutics and Helomics Corporation. I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation, it's Forms 10-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. With that said, I would like to turn the call over to Dr. Carl Schwartz. Carl?

Carl Schwartz

Management

Thank you, Elizabeth and welcome to everyone who has joined us today for today's second quarter 2018 earnings call. The focus of today's call will be on exciting changes that have happened at Helomics in the recent weeks. These developments have reorganized Helomics business model and are expected to support a rapid increase in revenue generation during the second half of 2018 and beyond. Helomics is now expecting to report approximately $3 million of revenue at the second half of 2018 which if the merger is completed and Helomics is operating as a wholly-owned subsidiary of Precision Therapeutics would be recorded as revenue to Precision. Later in the call, I'll also provide an update on our Skyline Medical division which as a reminder sells our STREAMWAY System which is our fluid waste management system for the healthcare industry. But first, an update on our activity in the Precision medicine industry. Since our last earnings call, we have signed a definitive merger equipment with Helomics. On completion of the merger, our ownership will increase from 25% which is our current equity stake to 100% and Helomics will start operating as a wholly-owned subsidiary of Precision Therapeutics. In very high level terms, Helomics is a fully integrated Precision medicine company that provides both clinical testing to patients, and contract research, CRO services to pharma and diagnostic companies to improve the effectiveness of current cancer treatment and help design new therapies for the future. This merger will provide Precision Therapeutics with all access to Helomics artificial intelligence, Precision Oncology insights integrated CRO capabilities which improves patient care and advanced development, innovative clinical products and technologies for the treatment of cancer. The merger is expected to close over the next few months subject to certain closing conditions including the shareholder vote. Integrating Helomics under…

Gerry Vardzel

Management

Thank you, Carl. On our last earnings call, I discussed our unique offering which is made of three interconnected pillars, each of which generate revenues in their own right while also driving business to each other, which is expected to accelerate sales momentum in the business. As Carl mentioned, over the past several weeks Helomics business model has undergone a transformation into one that still utilizes our unique and highly sought after offering that is supported by more sustainable revenue stream. As a reminder, our three pillars are as follows; precision oncology insight, CRO services, and the dChip. dChip is an acronym for digital health insights platform which is our AI, artificial intelligence, powered by informatics engine. I'm going to start today by talking about the first pillar, the precision oncology insight business which provides a personalized roadmap for oncologists to guide therapy and positively impact patient outcomes. We recently commercially launched the precision oncology insights platform which is already generating revenues for the business and is expected to be our main revenue driver through the remainder of 2018. This unique platform has living tumor tissue from the cancer patient to determine how the tumors respond to drug. When then we combine this drug response profile with other genomic and molecular data, the results are then analyzed by our artificial intelligence knowledge base detail to generate a roadmap that provides additional context to help the patient's oncologist to personalize their treatment. Not only does this drive revenue, but when we work to create a treatment roadmap for a patient, the profile of the patient's cancer tumor is added to the detail. As our patient specimen volumes grow and the data contained in dChip expands, dChip becomes even more effective and the value of this intangible asset grows. With the commercial…

Carl Schwartz

Management

Thank you, Gerry. In the Skyline Medical Division we continue to focus our effort on growing sales of the STREAMWAY System resulting in 9 units sold in the second quarter and a further 2 sold subsequent to the quarter-end. All of these sales were to hospitals, the medical centers in The United States including 2 units in the VA in Puerto Rico which came through our alliance relationship. Sales of the disposable products grew 19.5% in the quarter two than quarter one. We expect STREAMWAY sales to be heavily weighted towards the second half of the year as both domestic and international sales ramp. We are making solid progress against our commercialization product strategy in the international market with national [ph] focus on Europe. In July we were pleased to grant a European [indiscernible] with STREAMWAY to protect our competitive positioning in the market which we see as a validation of it's one of a kind value proposition that fulfills unmet need in Europe. We also trained a distributor for Portugal during the first week of July and hired and trained a distributor for Switzerland and Austria to target brand [ph]. Furthermore, we remain committed to investing in our marketing efforts [indiscernible] in Frankfurt, November which is the largest medical trade fair in the world attracting more than 5,000 exhibitors from 70 countries, as well as the first Interventional Radiology Convention at Portugal in September, and the IFAS Healthcare Convention in Zurich to commence this October. With that, I'll now discuss the financial results for the quarter. The financial results for the fiscal quarter ended June 30, 2018 were filed with the SEC earlier this afternoon. Revenue for the quarter ended June 30, 2018 was $359,000 compared with $107,000 for the quarter ended June 30, 2017. We sold 9 STREAMWAY…

Operator

Operator

[Operator Instructions] Our first question will come from Dana Allen [ph], private investor.

Unidentified Analyst

Analyst

On the STREAMWAY sales Carl, so you see this as just a seasonal or timing issue, you're not disappointed that the sales were down slightly from the first quarter?

Carl Schwartz

Management

I'm not like disappointed but yes, it is a seasonal thing and we're advancing our sales group over - increase the size and the breadth and width, and of course Europe sold, we - it just takes time to sell our system, so as we get all this going, we're going to have a much better third and fourth quarter as we move forward. So, I'm happy with them and I'm always disappointed, I'd like to have done more.

Unidentified Analyst

Analyst

Do you still think 100 units is possible for 2018?

Carl Schwartz

Management

We maybe a little bit short of that but it will be a good year, and it will be a hell of an advancement over last year which we didn't do anything.

Unidentified Analyst

Analyst

I'm glad to see the reduction in expenses, I did try, I couldn't read the whole 10-Q because it's big. But you mentioned it had something to do with investor cost or stock compensation, can you go with it in more detail and what the primary reason was that your expenses are down?

Carl Schwartz

Management

I would ask Bob if you can go into he can go into that in a little more detail if you can Bob?

Bob Myers

Analyst

Our expenses are down because we have been very cautious of what we've been doing and we have managed to consolidate our operating expenses and keep our costs low. The only area that we've gone high is in sales because we've increased our sales staff and we have eyed increased sales, we have hired technicians. So I think that we're in very good controlled path in terms of that.

Unidentified Analyst

Analyst

But what was the thing that Carl mentioned about - something about investor cost or was that for bringing in money or what was that cost?

Bob Myers

Analyst

We are currently looking at some investment strategy partners that we would not have to go back to the market in the third quarter. And these are partners that are looking at our Helomics discovery and our AI chip or artificial intelligence dChip partnerships, and this is much like foundation medicine [indiscernible].

Unidentified Analyst

Analyst

And with Helomics in the prior Q you talked that it would be cash flow neutral or positive in the third quarter, do you still feel that way?

Carl Schwartz

Management

Yes, we do.

Unidentified Analyst

Analyst

That will be extremely impressive and I know, that - these mergers I've been through myself, do take a little bit time but do you think that we're fairly close to the Helomics deal being totally - 100% finalized?

Carl Schwartz

Management

Yes, I would say we're close. I don't see - there will always be a snake in the oil, but right now I believe we're closed.

Unidentified Analyst

Analyst

And there are certain unusual things about your stock and I'm sure you guys are 100% aware of this. Your borrow rate per short is like 99% which makes it one of the highest expensed stocks to short out there; and I was wondering if your delisting in Germany was related to that that you saw some danger in being on the German market - where was your reasoning behind asking them to take it off, the German Exchange?

Carl Schwartz

Management

I really don't want to talk about it, that particular aspect of it but it was - we were not happy with that, but that's so much of what I want to say.

Unidentified Analyst

Analyst

And then another thing is - again, on this very high borrow rate but the services like NASDAQ stays at only like 10% or 20% of your stock is short but being at it has this extreme interest rate on it. So that means that shorts this year have lost like 70% of their money even if with the stock just was level. Do you think that that is the reported short percentage is wrong or - I'm sure you guys must think about this.

Carl Schwartz

Management

No, I don't know that we do think about it that much. The shorts are going to do what the shorts are going to do, we just have to focus on our business and move forward.

Unidentified Analyst

Analyst

I think the moves you're making are very impressive and you guys have a very bright future, so I'm very enthusiastic about you. At this point, is there anything you think the stock market investors are missing and if you pick one thing that they are missing about the future value at Precision what would it be?

Carl Schwartz

Management

I don't know that to be any one thing but certainly we're on the crux [ph] of it, I think a lot of growth in an area that we are positioned very well to grow in. So I would say to keep a close eye on it, so I think we're going to look really good here coming up in the next few months.

Operator

Operator

[Operator Instructions] We'll go next to Steve [ph], he is also a private investor.

Unidentified Analyst

Analyst

Has Helomics voted on in the merger, internally?

Carl Schwartz

Management

You want to answer that Gerry?

Gerry Vardzel

Management

We still have to do a vote but we're anxious to move forward and as Carl alluded to earlier, we don't see any reason why we can't get this closed.

Unidentified Analyst

Analyst

Timeline-wise, when will the shareholders be boarding the AIPT side? Is that going to be announced soon or…

Carl Schwartz

Management

I would think that starting the next 60 days or so if not sooner. I'm not quite sure of this but - Bob, you have anything to add to that?

Bob Myers

Analyst

Yes. We will have a filing that will come out in the next couple of weeks that will have a date for the annual meeting, that will be combined with the shareholder vote, we hope to have a vote by the end of September.

Unidentified Analyst

Analyst

What were the totally fully diluted share count be post-merger?

Bob Myers

Analyst

We're not prepared to answer that question at this moment, it depends on the final negotiations of the deal. So soon as we have that we'll get that to you.

Unidentified Analyst

Analyst

Have you guys thought about testing non-approved drugs like drugs that have not even hit the FDA - they are still in the phases as far as testing against tumors and things like that and being a service that way to prospective drug companies?

Carl Schwartz

Management

Gerry, you want to answer that?

Gerry Vardzel

Management

I think with that - that's exactly what we're looking at. Of course, we're under - as a CLIA lab, we have to proceed under the regulatory rules but with the recent signing of the law of the right to try a bill, we believe Helomics is positioned on this new law and how it will impact patients, drug makers and regulators. So we are looking at that area and we are moving forward. So this is exactly the area that we want to go down in terms of moving forward. We've had some initial discussions with multiple stakeholders to be able to move this and minimize the risk for both, the pharma company and others but we've been basically doing the right to try for the past decade and this is exactly where some - where we believe we have a significant impact in Precision medicine. So that's where we're going, we're not there yet but we believe we are well positioned.

Operator

Operator

Our next question will come from Randy Savage [ph], private investor.

Unidentified Analyst

Analyst

It was announced that you got the patent in Europe but is there any other regulatory issues or anything like that holding you back from selling a unit in Europe? And if not, when could you estimate that private first unit [ph] would be sold?

Carl Schwartz

Management

We're not aware of any crump [ph] we have from a regulation standpoint, and I think we're within 30 to 60 days of starting to - with starting to place units in Europe.

Unidentified Analyst

Analyst

Is it more difficult to deal with - I guess, some place in Europe or healthcare controlled by the government versus kind of private hospitals in U.S.? And do they make their sales cycle easier or more difficult?

Carl Schwartz

Management

I don't know that it makes it more difficult; obviously, right now it appears to be that our product builds a need in Europe and we're going to - we think we'll do fairly well there. So we don't anticipate any really serious regulatory problem with anyone at any of those European countries.

Operator

Operator

Thank you. And with that ladies and gentlemen, that will conclude our question-and-answer session. I would like to turn the conference back over to Dr. Carl Schwartz for any additional or closing remarks.

Carl Schwartz

Management

Thank you operator. We are very pleased with the foundation we have laid in the first half of the year which we believe positions the company for a meaningful revenue ramp during the remainder of 2018 at both Skyline and Helomics to report sales [ph]. To recap, we expect Helomics to generate additional revenues for its CRO services business. Most importantly, Helomics is launching it's dChip offering for the pharma companies which will drive both project-based revenue and subscription payments, thereby providing revenue growth and stability for many years to come. Moreover, as the specimen volume at Helomics has access to growth, so does the number of tumor profiles that are added to dChip which in turn increases the value of Helomics by also creating a more effective platform to improve treatment options for the patients of tomorrow. According to the report in BIS Research, the global Precision medicine market is expected to reach $141 billion by the year 2026 with the oncology market segment expected to grow at a compounded annual growth rate of 10.4% from 2017 to 2026. The role of Big Data and CROs is critical to this industry and this is where Helomics has a clear competitive advantage. Moreover, with genetic data becoming an increasingly valuable resource for drug makers, we are witnessing large sums of investment going into this market. Roche, for example, has spent US$4 billion to US$4.3 billion this year buying out two specialists in the cancer field, Foundation Medicine and Flatiron Health. Despite this there are currently limited means of investing in data for healthcare business through the public market. We are therefore very excited about the prospect of including the Helomics business under the Precision Therapeutics umbrella as we believe it is truly unique opportunity for investors. This is a transitional time for the company and I would like to thank all the investors who have joined us on this call today, and are supporting us since we began this journey. With that, I'll turn the call back to the operator for closing.

Operator

Operator

Thank you. Again everyone, that will conclude today's conference. We'd like to thank you all for joining. And you may now disconnect.