Epigenomics AG (ECX) Earnings Call Transcript & Summary
August 11, 2021
Earnings Call Speaker Segments
Operator
operatorGood afternoon, ladies and gentlemen, and welcome to the Epigenomics AG conference call regarding the half year results 2021. [Operator Instructions] Let me now turn the floor over to Frederic Hilke.
Frederic Hilke
executiveThank you very much, Chris. Hello, and welcome to Epigenomics investor conference call. My name is Frederic Hilke. I'm the Investor Relations Manager for Epigenomics . With me on the phone is the CEO of Epigenomics AG, Greg Hamilton. On today's call, we will be discussing first half 2021 results. This call is being webcast for anyone who would like to follow the presentation. The link can be found on the Epigenomics website in the Investors section. Before I hand over the presentation to Greg, let me point out some of the usual legal information. The following presentation will contain expressly or implicitly certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Please find some of these factors described in the safe harbor statement. And now I would like to hand you over to CEO, Greg Hamilton, who will continue with the presentation.
Gregory Hamilton
executiveThanks, Frederic. Good morning, everyone, and thank you for joining our first half 2021 earnings call. The company continues to advance our efforts to achieve Medicare reimbursement for Epi proColon via legislation. The Donald Payne Sr. Colorectal Cancer Detection Act now has 63 cosponsors supporting the bill because this legislation addresses racial disparity and the COVID-19 pandemic as it is a tangible method to increase screen rates among the unscreened population in the United States. The current legislative focus of the Biden administration is physical infrastructure such as roads and bridges. Most experts expect health care and racial equity legislation to be addressed by the Biden administration as part of the budget/reconciliation process still within this year. We will continue to actively pursue inclusion of our legislation as part of this process. The company intends to focus on a legislative path at this time prior to filing an appeal with CMS. If the legislative solution does not materialize within the remainder of the year, we will then look to pursue the appeal process. Epigenomics completed 2 capital raises in the first half of 2021. That generated gross proceeds of approximately EUR 7.5 million. In addition, the company has announced the issuance of convertible bonds that will raise up to EUR 18 million in gross proceeds. This placement is backstopped by our largest shareholder, Deutsche Balaton. As disclosed previously, the company is also in the process of evaluating strategic alternatives, including the sale of the company and/or assets. Due to disclosure requirements, all we can say at this time is the process is ongoing, and we will update everyone at the appropriate time. In order to maximize shareholder value, the company is focused on 3 critical activities for the remainder of the year. First, we continue to actively pursue Medicare reimbursement for Epi proColon via legislation. We believe our efforts in this area have advanced, and our opportunity for success resides in this year. Second, we are preparing for initiation of the clinical trial for Epi proColon Next-Gen in the first half of 2022. It is imperative that the company continues to move forward and create value via continued development of cutting-edge products. In order to accomplish this work, the company must be appropriately funded. Thus, our third area of focus is to close the offering for the convertible bonds in the current quarter. The financial results for the first half of 2021 were within the company's latest estimates. Revenue for the first 6 months was EUR 223,000 compared to EUR 322,000 in the first half of 2020. The adjusted EBITDA improved by approximately EUR 2.5 million, from negative EUR 5.7 million to negative EUR 3.2 million because of continued cost-cutting measures. Liquidity at the end of June was EUR 6.9 million. Our 2022 financial -- 2021 financial outlook remains unchanged at EUR 400,000 to EUR 1 million of revenue, and adjusted EBITDA and cash burn of negative EUR 7 million to negative EUR 9 million. We are focused on accomplishing our 3 key goals for the remainder of 2021. Achieving Medicare reimbursement, preparing for the Next-Gen clinical trial and completing our capital raise. We look forward to future updates this year. Thank you for joining our first half 2021 earnings call. I will now open the call for questions
Operator
operator[Operator Instructions] First question comes from Ulrich Huwald from Warburg Research.
Ulrich Huwald
analystIt's Ulrich. I've got a question. You mentioned that the evaluating all options, plan still underway. And does it also include still perhaps the license agreement or a sale of parts of the technology, perhaps for other cancer types. Could you evaluate a little bit on this. And clearly, we've seen still slow sales due to the missing reimbursement and I guess a fewer doctor visits due to the pandemic. Do you expect some improvement in the second half of the year in the U.S.?
Gregory Hamilton
executiveThanks, Ulrich. In regards to some of the options we're looking at, we really can't discuss anything more at this time. All we said is all options were on the table on -- so we continue to move that forward. As soon as we have an announcement, we will let you know. In regards to sales, we're right where we anticipated to be. Regretfully, we don't see a significant increase in screening rates right now in the United States in the second half of the year. COVID is continuing to spike in the United States again as I think it is in the rest of the world. So we continue to see more and more people not getting screened due to the pandemic. So we expect that to kind of continue between now and the end of the year.
Operator
operatorThe next question comes from Dennis Berzhanin from Pareto.
Dennis Berzhanin
analystDennis Berzhanin from Pareto. My first question was just a follow-up to the recent question about the strategic options. And I understand you can't talk too much about what's going on. But usually in the press release, there are some confirmation of the ongoing process of evaluating strategic options in a sale. But this time around, there wasn't much. So I was just wondering if you could confirm that this process is still ongoing and that has not ended. And then the second question related to reimbursement for Epi proColon. You mentioned that currently, the legislative option is the preferred or the most, I guess the way to interpret it is the most probable success of pathway. I'm just wondering what -- about the second option with NCD appeal process. I remember that the biggest thing last time with that, there was a change of leadership in the regulatory agency and we needed to wait and see once that resolves, we can go ahead with appeal process. I was just wondering if you could update us on how that's going? And if there is a progress made there? And if not, what are the challenges right now with the NCD appeal process?
Gregory Hamilton
executiveAll right. Thanks, Dennis. I appreciate the questions. We can confirm that the strategic analysis for alternatives is ongoing. So again, I really can't say anything more than that right now, but it is ongoing, and we are working on that. In regards to reimbursement, we are focused on the legislation much more so than the appeal to 2 main reasons. Number 1 is we really have advanced the legislative path since our last earnings call. The bill has also been introduced in the United States Senate, again, bipartisan introduction by both Republicans and Democrats. And we continue to raise the number of co-sponsors in the House. And ultimately, we believe of our 2 options for reimbursement legislation is our more likely path. And the reason is, is that, ultimately, this test really helps address 2 of the biggest issues of the current administration, like we've talked about racial disparity and the COVID-19 pandemic and the lower screen rates. So it is the only FDA-approved blood-based test. So with reimbursement, we think it is a viable solution to increase screen rates during COVID-19. And then from a racial equity side, I mean, clearly, the data is irrefutable that the screening rates are lower for people of color and that they -- these -- all people in the United States that are eligible should have the option of getting the blood test to improve screening rates and reduce cancer. So we do think the legislative path is more viable at this time. So we're really focusing our efforts there. Then as that relates to the appeal at CMS, we don't want to divert focus from the legislation to an appeal. And so at this time, it is better for us to focus on the legislation. And then -- but it is a finite window, and that window really, we believe, is this year. So we are focusing all our efforts in that area.
Operator
operatorThere is 1 follow-up question from Ulrich Huwald from Warburg Research.
Ulrich Huwald
analystPerhaps regarding the legislative efforts. I remember you said in the call earlier that it is possible that we will see an outcome end of Q3, early Q4. Is it still valid? Or what is your expectation in regard of this legislative process?
Gregory Hamilton
executiveYes. That could be a reality. It could also be by the end of the year. Or -- right now, the real issue is at what point does the U.S. Congress and House of Representatives address health care. So in Germany, I'm not so sure if you've been able to see, but basically the focus of current administration right now is on infrastructure and passing the bill for roads and bridges, concrete and gravel, and that has become closer. But what is now taking center stage is the budget/reconciliation process will have quite a bit of focus on racial disparity in health care is our understanding. So it really comes down to timing on when does Congress address health care legislation. It has less to do specifically with us and more to do with a macro view of at what point does Congress address that, and then that would be our opportunity for the legislation.
Operator
operatorAt the moment, there seem to be no further questions. [Operator Instructions] There are no further questions.
Gregory Hamilton
executiveOkay. Thank you, everyone, for joining our first half 2021 earnings call. We look forward to providing future updates. Thank you, and have a great afternoon. Bye.
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