Interpace Biosciences, Inc.

Interpace Biosciences, Inc.

$0.9
-0.1 (-10%)
Other OTC
USD, US
Medical - Diagnostics & Research

Interpace Biosciences, Inc. (IDXG) Q4 2016 Earnings Call Transcript

Published at 2017-03-29 00:00:00
Operator
Good afternoon, everyone. Thank you for joining us for the Interpace Diagnostics conference call to review the company's financial results and operations for the fourth quarter and for the year ended December 31, 2016, as well as recent developments. The news release detailing the year end and fourth quarter results was issued just after 4:00 p.m. Eastern Time and will be available on Interpace's website at interpacediagnostics.com. -- I'm sorry, www.interpacediagnostics.com. Before we get started, during the course of this conference call, the company will make forward-looking statements. We caution you that any statement that is not a statement of historical fact is a forward-looking statement. This includes remarks about the company's financial projections, expectations, plans, beliefs and prospects. These statements are based on judgment and analysis as of the date of the conference call and are subject to numerous important risks and uncertainties. These risks and uncertainties associated with the forward-looking statements made in this conference call are described in the safe harbor statement in today's news release as well as Interpace's public periodic filings with the SEC, including the discussion in the Risk Factors section in our Form 10-K for the year ended December 31, 2016, which will be filed later this week. Investors or potential investors should read these risks. Interpace assumes no obligation to update these. In addition, to supplement the GAAP numbers, we have provided non-GAAP information. We believe that these non-GAAP numbers provide meaningful supplemental information, are helpful in assessing our historical and future performance. A table reconciling the GAAP information to non-GAAP information is included in the company's earnings release, which is available on our website. Now I would like to turn the call over to Jack Stover, President and Chief Executive Officer of Interpace.
Jack Stover
Thank you, Matt, and good afternoon to everybody. Thank you for joining us today. I think we have a record crowd for a review of our year and fourth quarter ended December 31, 2016. With me today is Jim Early, our Chief Financial Officer. This is the first conference call we have had in a while, so we have a lot to cover. I will begin the call with an update on our progress, both for the year 2016 and to date. We will then review our financial performance for the year and for the fourth quarter of 2016 compared to the prior year. And following that, we will open up the call for your questions. As I get started, let me remind you of our overall mission, and I will on all of future calls as well. We are a fully integrated commercial company that provides molecular and diagnostic tests and pathology services to evaluate the risk of cancer by leveraging the latest technology in personalized medicine for better-informed clinical decisions and improved patient management. In terms of our performance, in accordance with our mission, we made significant progress in 2016. We completed our transformation to a fully integrated commercial company, providing molecular diagnostic tests. With the sale of a majority of our assets of our contract sales organization, or CSO, at the end of 2015, we continue to run out several less profitable contracts through March of 2016. Accordingly, through June of 2016, we were managing the transfer of that business to the buyer, Publicis Healthcare Solutions (sic) [ Publicis Healthcare Communications ], while we were rightsizing our molecular diagnostic business and operations of currently 61 people, including 23 people in sales and marketing. Importantly, while going through a major transformation, including significant cost reductions across the board, our business continued to perform well. Revenues for the year grew 39% compared to the prior year, led principally by the growth in our thyroid franchise of ThyGenX, our oncogene panel assay; and ThyraMir, our microRNA-based gene expression classifier, but also supported by the consistency of PancraGen, our integrated molecular pathology assay for risk stratification of pancreatic cysts that has been our anchor and on the market for over 8 years. During 2016, we also made commercial progress by expanding our product and service offerings to better serve our customer needs. In September, we received approval from New York State Department of Health to perform ThyGenX and ThyraMir testing on samples from New York patients. Additionally, we entered into an agreement with Lab Corp to co-market both ThyGenX and now ThyraMir. We launched PanDNA for those physicians who are interested in testing for specific DNA abnormality, present cyst fluid, and we launched our AccuCEA Insights service for those customers looking for additional first-line insight before reflexing to a molecular analysis of an assay. We also expanded our outreach beyond the U.S. by entering into agreements with distributors in Israel and Canada. Importantly, in December, we announced that Aetna, the third largest health plan in the U.S., agreed to cover ThyraMir for their 46 million members nationwide. We also signed an agreement with Galaxy Health with over 3.5 million covered lives to provide coverage for all of our integrated molecular pathology tests and services. In addition to our operating performance, cost reductions and reimbursement performance, we accomplished several very important and critical financing and restructuring milestones late in the year and recently, to improve our balance sheet and accordingly, better position our company for the future. Let me go over a few of those. From December 2016 through early February 2017, we raised gross proceeds of approximately $14 million in 4 separate equity financings. Coincident with these financings, we also negotiated to reduce $2.9 million previously established severance obligation to 5 former executives, down to $1.03 million, which we paid in February 2017. In March 2017, we entered into an agreement to restructure our $9.34 million of outstanding secured debt that had quarterly remaining payments of $1.33 million beginning April 1, 2017, into 2 new secured notes acquired at 95% of face value or $8.869 million. One of the notes is convertible into shares to common stock at a fixed price of $2.44 per share. And if any portion of the notes remain either not converted or not redeemed after June 2018, then the balance must be redeemed at a 125% of face value. And we also have the right to redeem the notes prior to their maturity at prices ranging from 115% to 125% of the principal amount of the notes. Further, once 55% of each of the new note balances are either repaid or converted, then the liens existing in our assets will be lifted. In March of 2017, we also agreed to issue 5-year warrants for an aggregate of 100,000 shares of common stock at a conversion price of $4.69 a share to our former noteholders, the former RedPath equity shareholders, in exchange for termination of future royalty and milestone payments related to the sales of certain of our products relating -- arising out of our acquisition of RedPath Integrated Pathology in October of 2014. I know that's a mouthful, but what I'd like to do is I'd like to focus on this restructuring and termination of royalties and milestones for just a minute more, so that you understand why this is such an important transaction for us. First of all, the restructuring reduced our need for debt payments by $4 million in 2017 alone, including avoiding a $1.3 million payment that would have been due on April 1. Next, we entered into multiple extensions on the original note payments. And each time we did, we had to renegotiate more restrictive terms, including adding covenants of default. Those renegotiations are finished. Together with the debt conversion, we were also able to eliminate future royalty and milestone obligations in exchange for a modest warrant. Lastly, we expect to be able to remove all liens once the balance in our notes are reduced by 55%, permitting a basis for longer-term growth for our company. In 2016, we also continued to invest in development and generated supportive clinical evidence to reinforce our diagnostic assays. We published clinical utility studies in diagnostic pathology and in the Journal of Clinical Gastroenterology related to PancraGen use in over 492 patients of multiple centers. We also have 5 PancraGen-related posters that will be presented at DDW Medical Congress in May of 2017 that speak to the clinical utility and expanded use of PancraGen as an ancillary test for solid lesions of the pancreas and bile duct. Additionally, we launched the multisite study to provide further clinical evidence of ThyGenX and ThyraMir in over 1,000 patients. We announced findings of a new study published in the Journal of Pathology and have reported our clinical experience with over 5,000 patients among 200 physicians in 4 posters at USCAP meeting in March 2017. As a reminder, going backwards a little bit, we currently have 3 commercially significant diagnostic tests commercialized on the market. Starting with PancraGen, which is the first and only U.S. commercially available molecular test for evaluation of pancreatic cyst and assessments of risk of concomitant or subsequent cancer. Under the current standard of care, too many patients are ending up on the operating table despite actually having benign outcomes. PancraGen has the specificity required in a molecular diagnostic test to avoid many of those unnecessary, risky and costly surgeries, potentially resulting in substantial cost savings to the health care system and improved patient outcomes. ThyGenX is our next-generation sequencing test for cancer assessment of thyroid nodules that improves preoperative diagnostic accuracy by providing physicians with greater confidence to rule in cancer for indeterminate thyroid nodules. In April of 2015, we launched ThyraMir, which is the first microRNA gene expression classifier for thyroid nodule identification. When ThyraMir is used in combination with our ThyGenX test, the 2 tests have both high sensitivity and specificity that corresponds to clinically actionable negative predictive value of 94% to rule out benign nodules and a positive predictive value of 74% to rule in benign nodules. The combination in these 2 tests allows physicians the ability to more accurately identify and rule out thyroid cancer with a single testing service, providing what we believe is a superior solution. We estimate that we currently have over 200 million lives covered for reimbursement for ThyGenX and ThyraMir. Our fourth test, BarreGen for Barrett's esophagus, is currently being soft-launched with key opinion leaders as we gather data on this assay that will assist us in seeking reimbursement in the future. Barrett's esophagus, as you may know, is a rapidly growing diagnosis that affects over 3 million people in the U.S. and over time, can progress to esophageal cancer. BarreGen helps physicians differentiate between patients at high risk of progression from those at lower risk of progression prior to the onset of cancer and well before observable changes in the cells. We believe that BarreGen can be a significant opportunity for us to seek development and commercial partners in the U.S. and abroad. We are excited about the potential of each of our diagnostic tests. Individually, they provide physicians with the ability to identify patients that are true candidates for invasive surgeries versus those that are available for active surveillance. This can allow for more personalized patient management strategies and could lead to reduced costs in the health care system. We are especially excited about the potential that our commercial expansion and growing reimbursement, supported by unequivocal clinical evidence, can have in our future. With that, I'd like to hand the call over to Jim Early, our CFO, to discuss the financial highlights in the fourth quarter and for the year. Jim?
James Early
Thank you, Jack, and good afternoon, everyone. Today, I would like to focus on some key elements in our financial statements. Net revenue for the year and fourth quarter of 2016 was $13.1 million and $3.12 million, respectively, a 39% and 22% increase over the comparable periods of the prior year. The principal reason for our revenue growth was our thyroid franchise, both in units and reimbursement improvement. As you may know, much of our revenue, in accordance with GAAP, is accounted for in a cash basis, while we are establishing reimbursement. Our gross profit for the year and fourth quarter of 2016 was $6.4 million and $1.35 million, a 155% and 55% improvement over the prior year, principally due to increased volumes and cost controls, including efficiencies. We were able to significantly reduce our operating costs with headcount reductions, pay rate adjustments and overall managing costs appropriate for the size of a company that we are. Sales and marketing costs for the year and fourth quarter of 2016 were $5.5 million and $1.3 million as compared to $10.4 million and $2.0 million for comparable periods of the prior year. Research and development costs for the year and fourth quarter of 2016 were $1.6 million and $0.3 million as compared to $2.3 million and $0.6 million for the comparable periods of 2015. General and administrative expense for the year and fourth quarter 2016 was $10.5 million and $2.8 million as compared to $16.9 million and $6.5 million for comparable periods of the prior year. As a result of the acquisitions and disposition of businesses in prior years, we also had several significant noncash accounting charges summarized as follows: we took an asset impairment charge in the third quarter of 2016 of $3.4 million related to a decline in the market value of certain assets acquired from Asuragen. We had a $15.7 million goodwill impairment charge in the fourth quarter of 2015 related principally to the acquisition cost of RedPath in 2014. During the year and fourth quarter of 2016, we had changes in the fair value of contingent consideration of $11.9 million and $10.7 million, respectively, and $8 million for both the previous year and for the fourth quarter of 2015. These charges represent changes in our projections related to previously acquired assets and refocusing by management, and these are all noncash items. Accordingly, net income loss for the year and the fourth quarter of 2016 was a loss of $8.3 million and a gain of $6.3 million due to adjustments as compared to an $11.4 million loss and $4.4 million gain for the comparable periods of 2015. When operating the company, we also used adjusted EBITDA as an important parameter and measurement of cash spent from operations. As we noted in our earnings release, we define adjusted EBITDA, a non-GAAP financial measure, as income or loss from continuing operations, excluding interest, taxes and amortization expenses as well as costs related to the revaluing of contingent consideration, charge-off of goodwill and other noncash charges. Our calculation of adjusted EBITDA for the year and the fourth quarter of 2016 was a negative $10.5 million and a negative $2.9 million, respectively, as compared to $3.4 million and a negative $6.0 million for the same periods of 2015. Further, evaluating cash flows that the net cash used in operations for the year ended December 31, 2016, was a negative $8.9 million as compared to a negative $19.8 million in 2015. Additionally, net cash provided by financing activities was $1.2 million in 2016 as compared to $5 million of cash provided by net financing and investing activities combined in 2015. That concludes the financial section. With that, let me turn the call back to the operator for questions.
Operator
[Operator Instructions] At this time, we'll take our first question from Yi Chen with Rodman & Renshaw.
Yi Chen
The first question, could you give us some color as to your expectation whether during 2017, you will continue to see revenue growth at a trend or at a rate similar to those observed in 2016, and whether in 2017, you will continue to reduce your operating expenses?
Jack Stover
I'm sorry, Yi, what was the last question about expenses?
Yi Chen
Whether you will continue to reduce operating expenses during 2017.
Jack Stover
Yes. Yes, thank you for the question, Yi. Let me deal initially with the revenue question. And that is that, first of all, we don't give guidance in terms of revenue. And we don't give it for a couple of reasons. One of which is that a sizable part of our revenue is cash-based versus accrual. And while it's easy for us to account for units, it's not as easy for us to do the actual revenue accounting yet. As we get more experience under our belts, we'll be better at being able to provide that projection. All that being said, if you follow the positive activities that we had in 2016, most of those, including the New York State approval and the Aetna approval, the 2 biggest commercial opportunities that we had, we're really late in the year. And effectively, in 2016, we haven't really recognized much, if any, of the value of accomplishing that. Additionally, we are planning and in the process of adding incremental or additional sales reps because they've been so effective for us, especially on the thyroid side. And we've gone through a major conversion on PancraGen in terms of changing the sales management team, upgrading their incentives and restructuring their sales group. So we're very hopeful that 2017 will be as successful as 2016 was in terms of growth potential, et cetera. But again, we don't give that kind of guidance. On the cost side, certainly, what you saw was that we were able to take extraordinary costs out of the system. And part of that was the transition that we went through going from a CSO business that had a molecular business to a standalone molecular business. We will need to rebuild some costs in areas such as in the marketing area, et cetera. But if you look at our relative expectation of costs as compared to revenue on a percentage basis, I think we're going to be able to run the business on a very comparable basis. Does that answer your question?
Yi Chen
Yes. My second question is during 2017, do you expect to launch any new tests? Or you are simply focused on expanding the market adoption rates of your current tests offered?
Jack Stover
Yes, Yi. Good question. When -- certainly, our focus is principally on growing our existing molecular business. That is the most profitable part of what we've done. But if you look at, again, at the end of 2016, we believe we had 6 product offerings that were being launched and going into the market. Many of those are first-line tests that are supportive of our second-line molecular tests. And we look at them as really new products. So we're expecting to see the benefit of those products in 2017. Our primary focus in 2017, other than the expansion of those incremental tests, is also developing our BarreGen assay, which we've been talking about for the last year or 2. But we currently have resources to be able to dedicate to BarreGen, and we're very hopeful of being able to move forward with that, and we're talking with partners currently. We think it's a big-enough market opportunity that it attracts the kind of partners that we need to move quickly into the marketplace. The nice part about it is the product is fully developed, so there's no developmental risk. It's really the commercial risk associated with BarreGen.
Operator
At this time, we'll move to Lauren Chung with Maxim Group.
Haeyong Chung
I wanted to ask about ThyGenX and ThyraMir. What percentage of the customers buy both versus one or the other?
Jack Stover
Yes. It's funny. Initially, ThyGenX was the only product that we had in the marketplace. The expansion in this sector has really been a function of adding ThyraMir. And currently, in excess of 80% of our patients on ThyGenX reflex to ThyraMir. So it's a very strong percentage.
Haeyong Chung
I see. And also, can you break down in terms of what the volume has been for both of those on a quarterly basis? I understand your cash recognition that makes it harder on the revenue numbers side. But can you comment on the volume?
Jack Stover
We don't track and disclose separate volume of individual assays, for the most part, for competitive purposes. When we do track revenue, revenue is a combination of 2 things, though: units and dollars. And as we look at sort of the combined units, from 2015 into 2016, yes, the growth of the overall unit volume on a quarter-by-quarter basis is very significant. So we're continuing to recognize that. We also say that most of our volume increase has really been on our thyroid part of our business. But we really don't disclose the individual units.
Haeyong Chung
Got it. On the reimbursement side, can you comment on what your projections are for the coming year? And also, if you can comment on in-network contracts.
Jack Stover
Yes. What are you looking for in terms reimbursement for the coming year?
Haeyong Chung
Yes.
Jack Stover
What specific question do you have? What are we expecting in terms of reimbursement?
Haeyong Chung
So in terms of -- yes, first, covered lives and also a specific sort of in-network contracts.
Jack Stover
Yes. In terms of covered lives, I think we disclosed in the press release that for ThyGenX and ThyraMir, we're talking about 200 million covered lives. And I believe on the PancraGen side, we talked about I think it's 97 million covered lives is where we are with PancraGen. It's interesting. The in-network and out-of-network evaluation of those lives is very tricky and critical in that with the nature of our reimbursement. And just briefly, if you step back and you look at our PancraGen reimbursement, it's roughly around $3,000. And if you look at our combined ThyGenX and ThyraMir reimbursement, it, too, is roughly, on a combined basis, around $3,000. And managing that process for in-network and out-of-network, the success we have in some of those contracts, out-of-network, could be more expensive on an in-network basis. So it's a very carefully managed process. The good news is that we have Greg Richard, who's our Senior Vice President of Sales and Marketing. And certainly, beyond sales and marketing, Greg's expertise is in the reimbursement area. And Greg has been principally responsible for a lot of the success we've had in that space and continue to have.
James Early
Maybe I can answer in one other way. We do have -- certainly, expectations for additional reimbursement in the upcoming year, we can never guarantee it. But in fact, it's a process, and oftentimes, it goes on for not months, but years. And we can generally tell when we're getting close to the process. And also, as we follow competitors in the marketplace, as more and more competitors also gain some level of reimbursement, that gives us a lot of confidence as well.
Operator
At this time, we'll move to David Veal with Morgan Stanley.
David Veal
My question is, what is the public float on the shares? And what kind of a -- the volume has been tremendous all year long, and what is your best guess on where the buying and selling is coming from?
Jack Stover
Yes, David. Thanks for joining us. Yes, as we take a look at the float, I'll give you a sense of where is -- or where it was on a presplit basis. Before our financings and the restructuring, we had a roughly 18 million shares outstanding. And our float at that time was basically about 11 million shares. Add to that some of the financings that have taken place and changes, et cetera, but the reverse stock split was effectively a 1-for-10 reverse stock split. So we're probably somewhere in that range. But in total, our shares outstanding are really around 5 million shares. And today, I believe we traded around 2 million shares. So there's a lot of interest in the stock. Quite frankly, while I'm very interested in it, and I spend a lot of time talking to prospective investors, we don't have a lot of time to really track down the investment process as to who's in and who's out and how that activity happens. But we're certainly thrilled to see the kind of volume we have and the kind of support we have in the marketplace.
Operator
We'll now move to Suraj Singh with RedChip Companies.
Suraj Singh
Now you addressed the equity raise as $14 million. Out of that, $9.3 million has been used for restructuring the debt. Is that correct?
Jack Stover
No. No. There are 2 separate activities. The $14 million that we raised is cash, and the $9.3 million was really a restructuring of debt for convertible debt and debt for new notes. So effectively, a third-party stepped in, a sophisticated investor, and acquired the debt from the former RedPath shareholders. So that didn't cost us anything.
Suraj Singh
Okay. So how are you going to use this $14 million for 2017? Are they going to be used for operations? Or what is it going to be used for?
Jack Stover
Well, a couple of things. And one of the things we talked about in our liquidity section is that in the fourth quarter of -- well, the third quarter and the fourth quarter of 2016, we were very cautious and careful about how we spent money. And we really extended payables to provide a level of financing for ourselves at that time. Certainly, part of the proceeds have been used to pay down some of that debt. But in addition to that, the working capital that we currently have and have generated, we're looking to reinvest in our products. Certainly, the nature of this business is it requires clinical investment, and we had several clinical programs that we didn't stop, but we had them on the back burner and slowed them down. We're planning to accelerate that. That typically generates additional patient and doctor interest. And as we mentioned, we have our BarreGen product and the whole business development process of seeking partners and developing that, both in the U.S. and internationally, take some additional capital to get that accomplished. And I'd say lastly is that when we did this conversion to a molecular company from a contract sales company, we took some pretty draconian cost reductions, both in terms of personnel and other costs as well. And we need to rebuild some of that. So that $14 million that we raised is going to expand the business and continue to invest in it but also to rebuild some of the programs that we had delayed before we were raising money.
Suraj Singh
And finally, do you have any cross-selling opportunities with your current customer base?
Jack Stover
Cross-selling, it's interesting you say that. The simple answer to that is yes, I believe we do. And I'll tell you why. When we take a look at it, the nature of our sales reps are that they come in at a very high level. So a good example is -- let's look at the GI business, our GI business, where we have 8 or 10 years of experience in that space. As we're in with our PancraGen product, we're in talking, for the most part, the EUS stocks. And now with the BarreGen product, we're going to be coming in at a slightly different level. But those high-level EUS stocks, we believe, who have had some success with us, will provide us the entrée to be able to commercialize and promote our BarreGen product. So the answer is yes. That's on the molecular level. But beyond that, there's been some interesting successes with companies that have been able to expand because they have access to the suite, in our case, the Endo suite and the GI suite, with a variety of different products. And I would tell you that we certainly have been talking to a number of potential companies that believe we have a strong pathway into those commercial opportunities.
Operator
And we'll move now to with [Daniel Schuz ] with Interpace.
Unknown Analyst
I had a question about, where do you guys see outlook on, if you can comment, on R&D? Where do you see yourself expanding into other areas of cancer for diagnostic assay?
Jack Stover
Sure. There's a variety of opportunities. But the focal point that we have is typically in areas of cancer where there are indeterminate evaluations. Meaning that there's a large number of cases in biopsies where physicians are not able to make a clear determination. We are certainly looking at plenty of opportunities in colon cancer, especially as it relates to our CLIA lab opportunity, working with an FDA-approved product that might provide a unique opportunity into that marketplace. I would say that with the products that we currently have, they keep us extremely busy, especially as we expand those products. But we are seeing lots of different opportunities, just with the base or the core technology that we have with our PathFinder technology.
Operator
And now move to [ Timothy Reib ] with -- sorry, a private investor.
Unknown Attendee
I was just curious as to the EU patent that was granted today for the microRNAs. And if you could comment on that as all as well as how that might affect future business development.
Jack Stover
Yes. Thank you for your question. Unfortunately, we've been tied up all day. I have not seen the patent that you're referring to. Can you give us a little more insight?
Unknown Attendee
Yes, it was on the European patent website.
Jack Stover
EU patent for microRNAs is biomarkers for...
James Early
[indiscernible]
Jack Stover
What's that?
James Early
[indiscernible] have to look at it.
Jack Stover
Yes. I just don't have any feedback for you. I'm looking at what you're looking at basically on the FDA website?
Unknown Attendee
No, it's the European Patent Office.
Jack Stover
Yes. That's where I'm looking at. But it says, Interpace receives EU, European Union, patent for use of microRNA biomarkers for distinguishing benign from malignant thyroid neoplasms. I just don't have an answer for you right now. I would say, overall, it's good news. But as you might imagine, we've been tied up in here all day preparing for the call and getting ready to file our financial statements.
Operator
The final question in queue will be from Sagar Rastogi with Crédit Suisse.
Sagar Rastogi
The question was just covered by [ Tim Reib ].
Jack Stover
Okay. Thank you. Sorry, we don't have any information on it. But as I said, it sounds like good news. And as we're sitting here, we're pulling it up and looking at it with you. So it sounds like it's just real time.
Operator
At this time, I will turn the call back over to management for any additional or closing remarks.
Jack Stover
Thanks, Matt, and thanks to all of you for joining us. 2016 was a solid and transformational year for Interpace. We hope to have many exciting developments over the next months, and look forward to updating you on our progress. Thank you all for your continued support, and thanks for joining us on the call.
Operator
And again, that does conclude today's conference call. Thank you all for your participation.