Redhill Biopharma's (RDHL) CEO Dror Ben Asher on Q2 2014 Results - Earnings Call Transcript

Jul.24.14 | About: Redhill Biopharma (RDHL)

Redhill Biopharma Ltd. (NASDAQ:RDHL)

Q2 2014 Earnings Conference Call

July 24, 2014 9:00 AM ET

Executives

Maurice Shani – IR

Dror Ben Asher – Chief Executive Officer

Ori Shilo – Deputy CEO, Finance and Operations

Guy Goldberg – Chief Business Officer.

Analysts

Scott Henry – Roth Capital

Operator

Good day and welcome to the Redhill Biopharma Q2 2014 Financial Results and Business Highlights Conference Call. At this time, I would like to introduce to the conference, Redhill’s CEO, Mr. Dror Ben Asher and Mr. Ori Shilo, Deputy CEO, Finance and Operations and Mr. Guy Goldberg, Chief Business Officer.

Before we begin, we will read from Redhill’s Safe Harbor statement. Please go ahead.

Maurice Shani

Thank you. This conference call may contain projections or other forward-looking statements regarding future events or the future performance of the company. These statements are only predictions and Redhill cannot guarantee that they will in fact occur. Redhill does not assume any obligation to update that information. Actual events results or achievements may differ materially from what Redhill projects today. Additional information concerning factors that could cause actual events, results or achievements to differ materially from those contained in the forward-looking statements can be found in the company’s annual report on Form 20-F and in its other filings with the Securities and Exchange Commission.

I now hand to Mr. Dror Ben Asher, Redhill’s CEO to begin.

Dror Ben Asher

Thank you, Shani and thank you Susanna and to those of you who are on our call live. Thank you for joining us. I will turn to Ori who will first discuss the financial highlights for the second quarter of 2014.

Ori Shilo

Thank you, Droh. Good morning and good afternoon everybody. We will provide a short overview of our financial results for Q2 2014 and for the first half of 2014 and we will be happy to take questions later on.

During the quarter, we did not booked meaningful revenues. For the first half of 2014 we had total revenues of $7 million, mainly from the licensing transaction of RHB-106 and related intellectual property to Salix Pharmaceuticals in February.

In terms of operational activities during the second quarter we had meaningful increase in R&D expenses to $3.2 million, compared to $1.7 million in Q1 2014. For the first half of 2014, we also saw an increase in R&D expenses to $4.9 million compared to $3.3 million in the first half of 2013.

The increase is mainly due to the ongoing Phase III 12 of our Crohn’s drug, RHB-104 and our H. pylori drug RHB-105. In preparation for the additional Phase III trial with RHB-102 plan to commence later this quarter.

G&A expenses during the quarter were approximately $1 million, which is similar to the previous quarter. Back in line we had operation loss of $4.1 million during the quarter compared to a provisional income of over $3 million in the previous quarter, mainly due to the revenues from the Salix RHB-106 outlicense transaction in the previous quarter.

In terms of cash position, we burnt about $4 million during the quarter and at the end of the quarter we had about $34 million in cash with no debt. Our cash position remains strong in the last continue with security in our extensive R&D plans and multiple late-stage clinical programs in the pipeline.

During the quarter, we also acquired the right MESUPRON, a new Phase II drug for GI cancer for which we paid in early July $1 million in cash which is now a further milestone down the road. We are also committed to pay royalties to our German partner WILEX ranging from mid-teens up to 30%. On future revenues and we will actually receive from the product later on.

At this point, I will turn the discussion back to Droh. Thank you.

Dror Ben Asher

Thank you, Ori. Today, I will review the status of our lead program as well as several selected important events that took place in the first half of the year. I would also refer to selected upcoming corporate events.

To refresh everybody’s memory, we are primarily focused on development of late-clinical stage orally administered treatment for gastrointestinal and inflammation-related diseases. That also includes GI related cancer. We are currently conducting two Phase III studies in the US with two of our lead gastrointestinal GI programs, RHB-104 for Crohn’s disease and RHB-105 for H. pylori infection.

Another third Phase III study in the US with a third lead program RHB-102 is expected to commence later this quarter in a new indication. So during the fourth quarter, the next quarter, after this one, we expect to have three Phase III studies in the US ranging with three different products in three different indications, one of which in particular RHB-105 for eradication of H-Palori infection is expected to generate top-line Phase III results during that quarter, during Q4.

To look back at the main use since the beginning of the year, very briefly, in January we completed two private-placements totaling approximately $20 million with leading US healthcare investors including OrbiMed, Broadfin and others and other strong investment institutions.

In February, we sold the rights to RHB-106 which is encapsulated bowel prep to Salix Pharmaceuticals under the terms of the life science Salix is responsible for all future developments and development costs of RHB-106.

We received $7 million in upfront payment, so we stand to receive another $5 million in milestone payments and most importantly, up to low double-digit royalties on future sales. Interestingly, Salix recently stated that they project peak sales of just under $300 million for this product if and when approved.

In March, we submitted together with our partners at IntelGenX, responsible with the FDA complete response letter regarding our new drug application of RHB-103 for migraine. As far as the US and the US market is concerned, our main focus right now is on securing an additional second FDA compliance supplier of raw material, as well as addressing the remaining FDA requests in order to receive a new PDUFA date target date for approval and subject to FDA review, hopefully eventual FDA approval.

For Europe, we remain on track to submit European marketing application with RHB-103 this quarter following another bioequivalence trial successfully completed in May earlier this year.

And after we successfully completed another bioequivalence trial with RHB-102, which is our antiemetic oncology support drug and announced that we plan to submit a European marketing application in the third quarter, this quarter and we remain on track for submitting this quarter as planned.

In May, we announced FDA clearance of the material amendment to our IND allowing the initiation of a Phase III study with RHB-102 for a new indication which is not yet disclosed.

RHB-102 is a proprietary extended relief oral pill formulation of the antiemetic drug Ondansetron. We remain on track for commencing this very important Phase III study with over 300 patients in the United States later this quarter Q3.

We estimate that if the Phase III clinical study is successful and the marketing applications are filed and approved by both the FDA and the European regulator, following the meetings that we had with both of them the new indication would significantly expand the potential market for RHB-102.

In June, we reported that we have initiated a long-term population pharmacokinetic, so-called Pop PK study as part of the ongoing RHB-104 Phase III study for the treatment of Crohn's disease.

The Prop PK study together with other supportive studies including various food effect study, a drug-drug interaction (DDI) study currently being reviewed and additional clinical and other studies are designed to satisfy various regulatory requirements for future potential marketing applications of RHB-104 for Crohn’s disease.

We further reported that over 40 clinical sites in the United States and the first site in Canada and Israel as well are actively enrolling patients for the RHB-104 Crohn’s study, the Phase III US study, and that the total number of planned clinical sites is being increased to approximately 90 sites in the U.S., Canada, Israel, and other countries.

Redhill recently became an official sponsor of the US Crohn’s and colitis transition the CCFA and our Phase III study in Crohn’s was recently featured in a recent CCFA awareness campaign addressing hundreds of thousands of Crohn’s patients across the nation. A second Phase III study with RHB-104 is planned to commence in Europe by the end of this year.

Also in June, we announce the acquisition from Germany’s WILEX of MESUPRON. MESUPRON is a proprietary orally administered uPA inhibitor primarily targeting gastrointestinal cancers. It is a substantial addition to our late-clinical stage pipeline as we continue to advance new and innovative therapeutic options for inflammatory and gastrointestinal-related diseases.

There is a lot of potential news flow during the remainder of 2014; I’ll mention some of the highlights including a top-line Phase III data from our Phase III study with RHB-105 for H-Palori infection.

The commencement on Phase III study with RHB-102 for a new indication submission of the marketing applications in the Europe with our antiemetic RHB-102 and our migraines drug RHB-103 as well as potentially a new FDA PDUFA date for RHB-103 commencement of a second Phase III study with RHB-104 for Crohn’s this one in Europe.

In addition, we continue our expensive business developments activities both in relation to partnering our existing programs and some of them in commercialization and in relation to potential acquisitions of new products that fits our therapeutic focus on developments and commercialization of late-clinical stage GI and inflammation-related conditions including cancer.

I will now turn back to Susanna and we will be happy to take questions you may have.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) We will now take our first question from Scott Henry from Roth Capital. Please go ahead sir. Your line is open.

Scott Henry – Roth Capital

Thank you and good morning. Just a couple questions, starting on the model, shares outstanding, should we expect that to jump up in the second half, I was expecting it to go up a little bit more in the second quarter.

Dror Ben Asher

Yes, we haven’t announced on any new plans or financing or anything like that. There are warrants that are in within the money and they may be exercised during this quarter but besides that currently we have no plans or we haven’t announced on any plans for increasing the amount of shares.

Scott Henry – Roth Capital

Okay, I just wanted to make sure all of your prior financings were fully reflected in the share count, it sounds like they are. And in the third quarter 2014, should we expect a $1 million R&D milestone for the MESUPRON deal?

Dror Ben Asher

Yes, it was paid in July. So by the end of Q2 it’s appearing as liability in the financial statement and it was paid during July.

Scott Henry – Roth Capital

Okay, great. Then shifting over to the pipeline, the RHB-104 trial in the US, I believe you said it’s up to 90 sites, I think prior it was 70. When should we think about data from that trial? I mean, I think the last expectations were late 2015, early 2016. Is that still a good expectation and as well, when should we think about futility analysis at the half way point?

Dror Ben Asher

Right, so, that will be a 104 Phase III Crohn’s study. We haven’t guided the market for data. What we have done was, increase the number of sites to up to 90. We also added a couple of countries. We currently have up and running and enrolling just under 50 sites. Almost all of them in the United States and we already activated a first site in Canada and Israel.

The likely timelines we will discuss in more detail I think pretty soon, the reason we haven’t guided is because we don’t know. We will know what the realistic recruitment pace much better in the next couple of months or so.

We don’t want to underestimate or overestimate our ability to recruit too early, but we will provide guidance. I would say that, we did resolve several issues that came up regarding recruitment. In the first few months of the study and we are rapidly increasing the pace of recruitment in the recent weeks. I hope this is helpful, Scott.

Scott Henry – Roth Capital

Really, thank you. And then on RHB-103, I don’t know if you hit on this in the prepared remarks, I guess, when do you expect the next data point from the FDA on that product?

Dror Ben Asher

The short answer is that we don’t know and the reason we don’t know is primarily that the main hold up price now as we previously announced is ongoing compliance discussions that are not specific to our product between the FDA and the active pharmaceutical ingredients.

The raw material manufacturer of our drug and that discussion is not specific to our drug, but affects dozens of products that are being sold into the United States and therefore the moment that these discussions are resolved, we are confident that they will be resolved satisfactorily.

But we don’t know exactly when. We hope to get a new PDUFA date. However we are not just sitting still what we are doing currently is focusing very much on securing an additional compliance manufacturer. We have made a lot of progress in that regard including a recent audit that we conducted on that manufacturer, it was a successful audit.

Therefore the moment that we have sufficient data to file with FDA and hope for a new PDUFA date immediately thereafter. Now whether this will be a PDUFA date that’s two months plus one or six months plus two, we don’t have enough information to tell, But roughly speaking, I think we are looking at potential approval, all goes well in the first half, or the second half of 2015.

Scott Henry – Roth Capital

Okay, great and a final question just back to the income statement, when we think about the R&D spend, should we think about a modest uptick in the second half versus the rate in the second quarter?

Dror Ben Asher

We are going to work, we said we are going to increase the R&D expenses mainly due to the two phase III that’s already ongoing and one that will start probably next month or so. And it’s going to be like that in the coming quarters of both in Q3, Q4 and also in early 2015.

Scott Henry – Roth Capital

Okay, great. Thank you for taking the questions.

Dror Ben Asher

Thank you, Scott.

Ori Shilo

Thank you

Operator

(Operator Instructions) We have no further questions at this time.

Dror Ben Asher

Thank you, Susanna and thank you for everybody that were listening live. We are always available and would like to see you at the upcoming conferences in which we will be presenting later this year. Thank you.

Operator

Thank you. That will conclude today’s conference call. Thank you for your participation ladies and gentlemen. You may now disconnect.

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