: Earnings Call Transcript auf Seeking Alpha
Frederic Hilke - Investor Relations
Greg Hamilton - Chief Executive Officer
Conference Call Participants
Dennis Berzhanin - Pareto
Simon Scholes - First Berlin
Bruce Jackson - Benchmark Company
Good afternoon, ladies and gentlemen. Welcome to the Epigenomics AG Conference Call regarding results Q2 2019. The floor will be opened for questions following the presentation. Let me now turn the floor over to your host, Mr. Frederic Hilke.
Thank you very much, Hanna. Hello and welcome to the conference call for the financial results of the first 6 months of 2019. My name is Frederic Hilke, I am the Investor Relations Manager for Epigenomics. With me on the phone is the CEO of Epigenomics AG, Greg Hamilton.
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.
Thanks, Frederic. Good afternoon, everyone and thank you for joining our first half 2019 earnings call. The operational highlights for the first half of 2019 includes CMS? acceptance of Epi proColon?s NCD application, the submission of the microsimulation model for publication, multiple positive peer-reviewed publications and the reintroduction of the bipartisan Donald Payne Sr. Colorectal Cancer Detection Act into the U.S. House of Representatives. We are still awaiting the opening of the NCD by CMS. We have been in communication with CMS. However, as per their policy, they won?t provide a definitive date on the opening of the NCD due to the limitations of CMS? available resources. We will issue a release as soon as the NCD is opened.
In regards to legislation, the approval of the U.S. budget was the major focus of the Senate and was approved in the last day of the session prior to the August recess. Thus, we expect the reintroduction of the Senate bill when the Senate reconvenes this quarter. Both the NCD and the legislative tracks are still viable means for achieving Medicare reimbursements, and we still believe we are on track to achieve this goal. s part of the reimbursement process, scientific publications about the clinical utility, health economics and the clinical reach of the product play an important role in building a body of evidence for the adoption of a new technology such as Epi proColon. In the first half of 2019, we have had numerous positive publications supporting Epi proColon. In March, the authors of the MISCAN microsimulation model presented a new microsimulation model that included for the first time Septin9. The conclusion of the authors was that Septin9 used annually reduce the incidence and mortality of colon cancer equivalent to FIT and more than Cologuard. This is an important finding as the MISCAN group is one of the key modeling groups contracted by the United States Preventive Services Task Force for the upcoming update to the USPSTF guidelines.
In Q2, authors from the Fred Hutchinson cancer institute published a health economics paper with two key findings: one, annual testing with Septin9 identified more cancers than FIT and Cologuard and two, Septin9 is cost effective for private payers. Additionally, in Q2, Henry Lynch and others published a paper on Septin9 in Lynch syndrome documenting the potential performance of Septin9 in this high-risk population as a potential future clinical expansion for the product. Epi does not have any current plans to invest into this area until after large-scale commercialization of Epi proColon in the average risk population. With the major microsimulation model, as we announced previously, the results are positive for Epi proColon in line with the recent modeling work just mentioned. The timing of the publication by peer-reviewed journal is beyond our direct control.
And as such, we are awaiting publication. We will alert the market as soon as the publication is released. In July, the Chinese IP authority issued a ruling that Septin9 for the detection of colorectal cancer was valid out of tissue, cell lines, etcetera, but not out of blood as someone skilled in the art at the time would not have reasonably anticipated blood as a possible sample type. Because the Septin9 product is a blood-based product, this effectively negates our licensing opportunity for now. We will appeal this decision as we believe the ruling is incorrect and inconsistent with more mature IP jurisdictions. Ultimately, this decision is a skillful way for the Chinese IP authority to recognize the validity of the IP, while at the same time effectively limiting it so that Chinese manufacturers can sell the product without paying the rightful developer and owner of the technology.
There is no formal appeal timeline. However, we do expect the process to exceed 1 year. As we have already disclosed, we did not include any Chinese licensing revenue in our 2019 forecast. We will update the market in the future regarding the outcome of the appeal. In the first half of 2019, product revenue increased by 84% year-on-year to ?660,000. Total revenue decreased from ?771,000 to ?679,000 compared to the same period in the prior year due to lower Chinese licensing revenue, as discussed earlier.
Our adjusted EBITDA was negative ?7.2 million compared to negative ?5.4 million, and the net result was negative ?7.4 million compared to negative ?5.8 million for the same period the prior year, mainly due to increased R&D expenditure for the post-approval and HCC studies and increased sales and marketing expense, but these expenses were lower than anticipated. The cash consumption in the first half was ?7.8 million versus ?4.2 million due to the higher operating cash outflows from previous year-end liabilities.
Epigenomics ended Q2 with ?9.1 million in cash and marketable securities. Our cash consumption is within our guidance, and we have sufficient funds to continue operations into 2020. As previously discussed, we will need to raise growth capital in the second half of 2019. We are currently evaluating the appropriate mechanism for the capital increase, and we will make the necessary disclosures at the required time. We continue to enroll patients into our U.S. cross-sectional liver cancer study. We remain on track to initiate the prospective FDA trial by the end of 2019.
We are updating the 2019 financial outlook with a revenue range of ?2 million to ?4 million and adjusted EBITDA of negative ?12.5 million to negative ?14 million and a cash utilization of negative ?13.5 million to negative ?15 million. Despite year-to-date 84% product revenue growth, larger commercial adoption is still hampered by lack of Medicare reimbursements and the fact that we are still awaiting publication of the microsimulation model. Medicare coverage is the #1 goal of Epigenomics, and this is the most important milestone for our future success. With the acceptance of the NCD, we know that we will get a review and a decision on our FDA-approved product. We are doing everything within our control to accelerate this process as much as possible. We continue to see test volume growth year-over-year. However, large-scale adoption is still dependent upon reimbursement. We also remain on track to initiate a prospective FDA trial for liver cancer by year-end. In order to position the company for success in 2020, we estimate the company will require additional growth capital in the second half of the year and we are currently identifying the best mechanism for this.
Thank you for joining our first half 2019 earnings call. I will now open the call for questions.
[Operator Instructions] The first question is from Dennis Berzhanin of Pareto.
Hi, this is Dennis Berzhanin from Pareto Securities. My first question is just to follow-up on the NCD process and your communication with CMS. I know you mentioned that CMS has not given you a date where they can open the application, but in your estimation, is this something that could take a few weeks or could this possibly drag on for many months or more? And the second part of the question is you didn?t seem to speak with CMS, have they given you any other feedback or communication related to this process? Thank you.
Thanks, Dennis. In regards to our communication with CMS, they will not give us a definitive date. That said, we do not expect this to take 6 months from now or something like that. We do expect it to be a much shorter timeline. I would love for them to call us tomorrow and say they are going to open it tomorrow, but we don?t know if that will happen, but they have given us an indication that while they have been busy in the spring and summer, they do expect to open our NCD what they call as timely, but again, they will not give us a definitive date.
Okay. And the second question I had was related to the China patent infringement case. But I just wanted to dig deeper a little bit and try to understand, there was a high degree of confidence earlier in this case. And given how the case ended, what do you think exactly happened and how do you think ? what has to be different for you to win the appeal? And what are the expenses associated with going through the deal process? Thank you.
Thanks. So in regards to the China IP, we still believe our IP is very strong. But ultimately, China IP interpretation is very different than the interpretation of IP in the United States and Europe. Ultimately, what happened is the Chinese IP authority made a decision that technically our IP was sound. We can detect colorectal cancer via Septin9. But in essence, they found a clever way to, in essence, say that the IP is valid, but the use for the product out of blood is invalid, thus allowing the Chinese manufacturers to sell the product without paying a royalty. We do believe we have a very strong case in appeal. The appeal does not go to the Chinese IP authority. It actually goes to the Chinese Supreme Court. So we actually have a more, what I would say legal-based opinion available to us in the appeal. So we feel very confident in the appeal. The challenge is it just takes time. So as we said, it will be at least a year before we hear anything on the appeal. So as we have said previously, we did not include any 2019 revenue in our estimate for China. And so basically, the Chinese market will be on hold for us until we get that appeal decision in the future.
Perfect. And could you give us a rough estimate of how much the expenses you think will be just going through this process of appeals?
They are fairly negligible. It?s not like the United States or Europe where that process can be expensive. Those numbers are already incorporated in what we will spend in our guidance this year and it won?t materially affect our guidance at all next year.
Excellent. Thank you.
The next question is from Engle Thomas. The floor is yours, sir.
This is Engle Thomas. I was asking you at the on the 15 of March about your opinion, how much you will make, and you said it?s about ?3 million to ?6 million. And today, they?re ?2 to ?4 million in cash. What I want to know is what happened, what because you said last time that is without reimbursement. So, what changed the amount of the forecast?
Yes. So, when we said that, we were very clear that we anticipated that to be back-end loaded in the second half of 2019. We had anticipated, as we said, the microsimulation model to be published already, which we could use then to help market the product because we believe that the data out of that microsimulation model is very strongly supports the adoption of Epi proColon not only for reimbursement but for medical guidelines. And therefore, labs would start adopting the product at a rapid rate in the second half of 2019. One of the decisions that we did make in regards to the microsimulation model based upon management decision and feedback from many investors is we have submitted the publication to very a very reputable journal. And regretfully, with the reputation comes time lines that at times can be longer than we would like. And so, we do want to make sure this paper is published in a reputable journal. We have it at a reputable journal. And because of that, the timing did not happen in the first half. We?re about a month over that time line right now, but that does affect what we do believe is going to be the adoption rate in the second half. Thus, we?ve updated our guidance accordingly.
Okay. And one more question to the microsimulation model because do you think that it?s normal that there?s whatever normal means in that way, that the publication is it?s like looking in the glass bowl? They said they don?t have enough personnel or staff to work on it, really. I mean is it tactics? Or what do you think is behind that? Because I think you don?t keep it or you don?t think that it?s normal at all that the publication is so long in the future, and they don?t know, and they haven?t got people to do this. I mean every shareholder is looking, and we are very surprised that nothing is really going on in this because it?s positive. It might be negative. But you said and everybody said it?s positive. So, we need this, the positive news as well for Epi in general and the CMS.
Yes. So just to be clear, two separate milestones, okay. So, CMS is the one who does not have the available resources to open the National Coverage Determination review, okay? That?s a government agency. And they are they have a very small group that runs coverage and analysis. These are the people who evaluate the NCDs, and we do know that they have multiple NCDs on their list that they are reviewing and in the queue. So that?s a separate group. So that is what it is, and that has been confirmed by others, and we know that there are multiple NCDs in front of CMS right now. And they have been issuing NCD decisions recently. In regards to the publication, that?s a separate process where we submit a manuscript to a particular journal. The higher-end journals have review times that can run longer, and the process is not always consistent. By that, I mean they can take many months to do certain items. For instance, we?ve had previous publications that have been accepted and not been released for 3 months after they have been accepted. And that?s purely their journal?s decision. And so, when you submit for a publication, you?re under a publication embargo. We can?t say anything about the publication other than we have submitted. And so that?s just the reality of peer-reviewed publications, and that?s where we are at. So, trust me, we would love to be having to head out in the market already. But at the end of the day, we do not directly control that; the publication does. So, but we remain extremely confident. We know the data is good. We feel very, very good that we?ve had 2 recent publications, one by the MISCAN group and another by out of the Fred Hutchinson that have various microsimulation models, and all of them point to the direction that Septin9 is a very effective tool in colon cancer screening. So, we are very positive that all of this data is aligning in the right direction.
Yes. But you know every shareholder and I think you as well, everybody in your team and the shareholders, we?re looking forward. And we see, okay, we?re running out of money, we?re pressured on time. And regarding the today?s how do you say cost, the share cost is running low, minus 20%. I mean everybody seems to get in panic, so because...
Yes. And we believe that I mean first of all, the company is significantly undervalued, and that is clearly, we believe, an overreaction from the market. The reality is we are in a good position and that the product works. We have data that?s already come out that says the product works, and we have a major publication coming out that is going to support that, we believe, in a very significant way. And we?ve always been very clear that we needed to raise money in the second half of 2020 under all circumstances. Even if the publication was already out, we know we need to raise money. So, we believe we?re in a very strong position going into 2020. We are extremely optimistic about this product and what it will do for the marketplace. Regretfully, timing has not been on our side. But as a management team and the Supervisory Board, we continue to push forward with all of our effort, such that we will be very successful in the future.
Thank you very much. Greeting to Greg and the team.
Thank you, so much.
The next question is from Simon Scholes of First Berlin. The floor is yours sir.
Yes, good afternoon. About a couple of weeks ago, you published an article from the American Health & Drug Benefits publication, which also features a simulation model. I was wondering what commonality there is between the results featured in this model and what might be upcoming in your microsimulation model.
Yes. So, Simon, we want to be careful because we?re under publication embargo, so we can?t disclose what the data specifically is in the upcoming publication. But we have publicly said that the results align with the previous publications: one being the publication you just referenced, which was out of the Fred Hutchinson cancer institute; and also, the MISCAN presentation at DDW. And basically, what they say is that Septin9 used annually reduces the incidence and mortality of cancer, either equivalent to or greater than FIT and Cologuard. So those are very positive and very powerful statements that ultimately, we believe, will affect the adoption of our product. And to date, we really haven?t had that data out in the marketplace showing the clinical utility of the product. So, having those 2 other publications that align with the big one we have coming out we view is very positive.
Okay thanks very much.
[Operator Instructions] The next question is from Bruce Jackson of Benchmark Company. The floor is yours sir.
Hi good morning. While you?re waiting for the all of these different things to run their course, are there any other activities you can do to help prepare for launch? And maybe you could tell us about that.
Yes, Bruce. So, we are doing that. We are doing a both a public relations campaign relative to the microsimulation and a physician education campaign we are working on as well because we clearly want to be able to take these publications and explain to the GI community, specifically key opinion leaders, what the data means and how it will impact, we believe, the screening rates in the United States. And ultimately, that?s going to be the benefit of the product, which is we know that it works. It works well. And because it?s the only product out of blood, we do believe that for the first time ever, the United States is going to have the opportunity to get the screening rates above 65%, which would be a major victory in this space. So, we are actively preparing those campaigns right now. So, when the publication does come out and then the NCD is under review, and we believe we would get a positive coverage decision, we can hit the ground running.
Okay, great. And then the other thing I wanted to ask you about was the U.S. Preventive Services Task Force. So, the last time they went through this process, they didn?t seem to be particularly interested in the cost effectiveness of screening. It seems like this time around they?re taking a slightly different approach. I was wondering if you could sorry, for the background noise. I was wondering if you could talk about the change in the approach and how that might help you with U.S. Preventive Services Task Force this time around?
Yes. I mean, Bruce, it?s a great question. No one really knows to what extent the USPSTF and the modeling group that they?ve contracted with, for example, MISCAN, are going to really incorporate cost effectiveness. Historically, they?ve shied away from that and only focused on the clinical utility. However, if you look at the research plan that got approved for the upcoming guideline review, you?ll notice that they plan on evaluating Cologuard with and without FIT. And that?s a pretty significant nuance because why would you do that, right? At the end of the day, Cologuard?s approval is as a product that incorporates it. There is no Cologuard without FIT. But the fact of the matter is the USPSTF is going to evaluate that product with and without FIT. And one could only assume it?s because of the health economics, i.e., what incremental value are their DNA markers adding relative to the FIT component of their test. So that?s the big unknown. For us, we think it?s a non-issue. I mean as you saw, we just published a paper on health economics. We know ours is very consistent. We know what the rate is, and we believe we will come out on top. I mean actually, the MISCAN group, the publication they did at DDW did include a cost effectiveness model. And in that model, they said that Septin9 was the most cost effective. Now we we?re not sure of all the numbers they used in there. And we once they go through and do it for USPSTF, we?re not sure what the final number is going to be, but we do believe that Septin9 is going to come up favorably in that analysis as well.
Alright. That was really helpful. Thank you and congratulations on all of the progress you made during the quarter.
Alright. Thanks a lot Bruce.
[Operator Instructions] There are currently no further questions in the queue.
Thank you everyone for participating in our first half 2019 conference call, and we look forward to giving you further updates in the near future. Thank you so much. Bye.
es stellt sich die Frage, wieso der zeitliche Rahmen für die fehlenden Ressourcen jetzt erst und nur nach Nachfrage bekannt gegeben wurden....auf einer PowerPoint-Präsi hatte GH beispielsweise den 01.07. reingeschrieben, wohlwissend dass es im Sommer nichts mehr damit wird.
Und wenn ich die Aussage jetzt so interpretiere, dass es im Herbst soweit sein wird, so kann es theoretisch auch Ende November sein (dann ist immer noch Herbst).
Alles Spekulation. Es weiß einfach niemand außer den Nasen bei der CMS selbst. GH weiß genau so viel wie wir. Und in der Präsentation musste er einfach mal was annehmen um den ganzen Prozess aufzuzeigen.
Vielleicht habe ich es falsch verstanden....aber aus dem Earnings Call Transcript geht doch hervor, dass gegenüber Epi die Aussage getätigt wurde, dass man bei CMS im Frühling und Sommer ausgelastet sei. Das ist doch ein ungefährer Zeitraum. Dann weiß ich doch zumindest, dass es nicht zum 1.7. oder zum 1.8. startet. Wir wurden was den Zeitraum betrifft völlig im Dunkeln gelassen.
und meine annahme herbst und der offizielle herbstbeginn, ist doch nur wieder reine spekulation...... die ressourcen können auch schon morgen frei werden oder erst übermorgen oder nächste woche oder nächsten monat.
mogli und guru schreiben es zum x ten mal richtig, hamilton weiss es auch nicht und würde es uns auch gerne verkünden 10.08.2019 geht es mit prüfung los oder 15.08.2019 wird ms veröffentlicht.
warum sollte er es auch nicht wollen???
nenne mir nur einen vernünftigen grund , warum er uns die daten (wenn er könnte und dürfte) verheimlichen sollte.
glaubt denn einer wirklich, dass ein ceo positive news seiner firma zurückhält?????
bei aller meinungsfreiheit geht mir manchmal einiges zu weit.....
Genau. Von Sommer oder Herbst wurde nie geredet. Es hieß immer ? Zur Zeit keine Ressourcen?!! Natürlich war bei einer Meldung im Mai der Sommer naheliegend. Die Leute bei der CMS- einer Behörde- haben wie in den USA üblich ca 2 Wochen Ferien im Jahr. Die haben also keine Sommerpause oder so was. Anfangen können die also jeden Tag oder auch nicht.
Epi-Pressemitteilung vom 03.05.19: Sobald die CMS ausreichend Kapazitäten zur Verfügung haben, wird die NCD mit einer 30-tägigen Periode zur öffentlichen Kommentierung ?eröffnet?. Anschließend müssen die CMS per Statut innerhalb von sechs Monaten einen Entscheidungsvorschlag bekannt geben. Wenn dieser Vorschlag positiv ist, folgt eine weitere 30-tägige Kommentierungsfrist. Eine endgültige Entscheidung über die Erstattungsübernahme wird die CMS dann innerhalb von 90 Tagen nach dem ersten Entscheidungsvorschlag veröffentlichen.
Danke für Deine Mühe und Deine Zusammenstellung !!!
Nenn mich Korinthenkacker, aber ich "spinne" jetzt mal Deinen Text noch optimal zusammen :D (ich gehe von 1 Monat = 30 Tage aus)
kürzeste Zeit wäre aber dann :
30 Tage (1 Monat) Kommentierungsfrist 1 Tag (optimal innerhalb von 6 Monaten; sagen wir, weil die MS so aussagekräftig ist, dass jeder instant überzeugt ist) 30 Tage (1 Monat) Kommentierungsfrist welche zu den max. 90 Tagen der Entscheidung gerechnet werden, optimaler weise dann 31 Tage
kürzest wäre dann 2 Monate uind 2 Tage :D
30 Tage Kommentierungsfrist 6 Monaten 90 Tage (die 30 Tage der zweiten Kommentarfrist eingerechnet)
d.h. 10 Monate
Beginn 1.9.2019 Ende 30.06.2020 (also 1 Monat später als in Deinen Beispielen)
" aufgrund begrenzter kapazitäten haben die cms aktuell noch nicht mit der überprüfung begonnen. wir hoffen aber, dass es bald soweit sein wird, so dass wir einen festen zeitrahmen haben, an dessen ende klarheit über die erstattung von epi procolon herrschen wird. "
meine anmerkung: klarheit besteht lediglich hinsichtlich einer maximalen zeitdauer, also 9 monaten. es könnte aber durchaus sein, dass eine geringere zeitspanne benötigt wird.
dies ist jedoch zur zeit lediglich eine spekulation.
wie Du schon geschrieben hast : " allerdings sind die cms verpflichtet, innerhalb von maximal neun monaten nach beginn des prüfungsprozesses zu einer endgültigen erstattungsentscheidung zu gelangen . "
Stellt sich die Frage, beginnt der Prüfungsprozess vor den ersten Einwendungen oder erst danach ? Ich würde mal sagen, erst nach den Einwendungen danach, also doch 10 Monate.
Sie können ja erst mit dem Prüfen anfangen, wenn alle Einwände auf dem Tisch liegen