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Fortress Biotech, Inc. (FBIO)

Q3 2012 Earnings Call· Wed, Nov 14, 2012

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Coronado Biosciences’ Third Quarter 2012 Results. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at time. (Operator Instructions) As a reminder, today’s conference call is being recorded. I’d now like to turn the conference over to your host, Dr. Lucy Lu, Chief Financial Officer. Please go ahead.

Dr. Lucy Lu

Management

Great. Thank you. Good morning, everyone. Thank you for joining us. This is Lucy Lu, Chief Financial Officer for Coronado Biosciences. Thank you and welcome to our third quarter 2012 financial results conference call. Before we begin, I’d like to remind everyone, that various remarks that we make on this call will contain forward-looking statements, including those regarding the timing of clinical trial initiation, enrollment and results, potential future clinical trials, the therapeutic and commercial potential of our product candidates and their regulatory pathway, intellectual property position, our manufacturing, supply and other collaborative arrangements and the sufficiency of our cash resources. Forward-looking statements involve risks and uncertainties that could cause our actual results to differ significantly from those projected. Additional information concerning these risks and uncertainties is contained in the Risk Factor section of our quarterly report on Form 10-Q for the third quarter ended September 30, 2012 and in the company’s other filings with SEC. With that, I’d like to turn the call to Dr. Bobby Sandage, President and CEO, who will begin the presentation. After which I’ll provide you with the summary of the financial results for the company. Bobby?

Dr. Bobby Sandage

Management

Thank you, Lucy. Thank all of you for joining us this morning for Coronado Biosciences earnings call to discuss the financial results for the third quarter 2012 and I’ll also provide an update on the development of our various programs. With me on the call today in addition to Dr. Lucy Lu is Noah Beerman, Coronado’s Chief Operating Officer; Dr. Karin Hehenberger, our Chief Medical Officer; and Dale Ritter, our Chief Accounting Officer. Our lead product TSO or you may know it is Trichuris suis ova, its currently being evaluated in two Phase 2 clinical trials for the treatment of Crohn’s disease. One of these trials which we refer to is TRUST-I is being conducted by us here in United States and other one TRUST-II is being conducted in Europe by our development partner, Dr. Falk Pharma Company. In addition, we are supporting a selected number of investigators conducting studies in other autoimmune diseases. Our other product CNDO-109 is an immunotherapeutic product for the treatment of cancer and our initial focus is on the acute treatment of acute myeloid leukemia or AML. During the third quarter we continued to improve the financial position of the company. In August, we completed a $15 million debt financing deal with Hercules Technology Growth Capital and in few minutes, Lucy will review the terms of that deal and the impact of this additional cash to our balance sheet. In past quarter, we also welcome Dr. Harlan Weisman y to our Board. Dr. Weisman brings over 20 years of experience as a Senior Healthcare Executive and position responsible for the development, regulatory approval and launch of innovative biopharmaceutical medical device and diagnostic products. Dr. Weisman is the former Chief Science and Technology Officer for the J&J Medical Devices and Diagnostics Group, as well as the…

Dr. Lucy Lu

Management

Great. Thank you, Bobby. During the third quarter, we secured a $15 million loan from Hercules Technology Growth Capital. The loan was fully funded at closing and provides us with additional capital to support our clinical program. The loan carries an interest rate of approximately 9.25% and is due payable in installments over 42 months, including an initial 12 months interest-only period. We ended the quarter with $47.5 million in cash where we believe we will be sufficient to fund our operations into the first quarter of 2014. I’d like to now turn to our P&L. Our net loss in the third quarter ended September 30, 2012 was $5.9 million, compared to the net loss of $3.4 million in the third quarter ended September 30, 2011. This increase is primarily due to the increased in research and development expenses associated with our increased clinical trial activity. R&D expenses were $3.8 million versus $1.8 million for third quarter 2011, primarily related to our TSO program. G&A was $2.1 million this quarter, up from $1.8 million for the 2011 third quarter, primarily due to increased staff and related costs. Our net loss in the nine-month period ended September 30, 2012 was $19 million, compared to a net loss of $29.6 million in the same period ended September 30, 2011, a decrease of $10.7 million or 36%. Included in the 2011 net loss was $20.7 million charge for in-process R&D related to our acquisition of TSO. Excluding this expense, our loss in the nine-month period ended September 30, 2011 was $8.9 million, which consisted almost entirely of R&D and G&A expense. Our net loss in the nine-month period ended September 30, 2012 is $10 million. We’re 112% greater than our loss in nine months period ended September 30, 2011 excluding the in-process R&D expense. R&D increased $7.8 million consistent with the change between the three months period. This increase is primarily due to increase TSO development process, which included a $3.4 million payment to Dr. Falk Pharma. G&A was up $2.2 million primarily due to increase staff and related cost. We used $16.1 million of cash in operations in nine months period ended September 30, 2012, which included a $3.4 million of payments to Dr. Falk Pharma. We express our quarterly loss and quarterly cash burn to increase in the coming quarters as our clinical trials in TSO at CNDO-109 increased patient development. We filed $75 million Shelf Registration Statement in September when we became actually eligible. Included in that is the $30 million asset market issuance to our ATM facility with MLV that we intent to access only opportunistically to supplement our cash position. I will now turn the call back to Dr. Sandage for closing remarks and Q&A session.

Dr. Bobby Sandage

Management

Thank you, Lucy. So the results from the two Phase 2 Crohn’s studies and possibly those in psoriasis and autism should make and could make the second half of 2013 a daily rich time for Coronado. The recent debt deal, we have a stronger balance sheet which will help us to continue to execute on our business plan. We will have cash into the first quarter of 2014 by which time we expect to have topline results from both the phase II studies at TSO in Crohn’s disease. As you can see, ’13 been exciting time for Coronado Biosciences and we sincerely appreciate your support. Look forward to meeting with many of you in New York City during that Piper Jaffray conference in November, with our Oppenheimer Conference in December. Well, I thank you for taking the time this morning to listen to our 2012 third quarter call. Operator, I’ll now like to open it up for questions.

Operator

Operator

(Operator Instructions) Our first question comes from Joe Pantginis of Roth Capital Partners. Please go ahead.

Joe Pantginis - Roth Capital Partners

Analyst

Hi. Good morning. Thanks for taking the question and congratulations on the progress.

Dr. Bobby Sandage

Management

Thanks, Joe.

Joe Pantginis - Roth Capital Partners

Analyst

Bobby, TRUST-I started in August and you’re expecting data in second half of ‘13 topline data. So that could be considered relatively rapid. You did allude to the call that enrollment is progressing nicely. So just wondering maybe can you provide some, may site feedback or anecdotes regarding physician interest as well as garnering patient interest as well?

Dr. Bobby Sandage

Management

Yeah. It’s still early but we have over half the sites that have drug on site that are screening patients. And it’s actually been in those sites that are up and running. It’s been pretty easy to recruit the patients there. They are looking for alternatives especially with some of the more powerful immunosuppressants. So we’re getting a lot of interest from the sites and the patients because they are looking for alternatives.

Joe Pantginis - Roth Capital Partners

Analyst

Now that’s very helpful. Thank you. And then just, from a manufacturing standpoint, can you just remind us your ability to manufacture product for these studies as well as any future plans if you look to go into a pivotal studies?

Bobby Sandage

Analyst

Yeah. We have sufficient supplies to easily give us through the Phase 2 program. And we’re in the process as we speak of scaling up the manufacturing so that we will be way ahead. In fact, we’re going to be ready for Phase 3 probably six months ahead when we would actually start the Phase 3 daily. So, we are right on track and the scalar process will give us through, we believe, the first couple of years of commercialization. So, things right on schedule. We’re planning for success and there should not be any hiccups here at all.

Joe Pantginis - Roth Capital Partners

Analyst

Okay. Thanks a lot guys.

Dr. Bobby Sandage

Management

Thank you, Joe.

Operator

Operator

Our next question comes from Boris Peaker of Oppenheimer. Please go ahead.

Boris Peaker - Oppenheimer

Analyst

Good morning. Can you hear me?

Dr. Bobby Sandage

Management

Yeah. Hi, Boris. Thank you.

Boris Peaker - Oppenheimer

Analyst

Thank you for taking my question. So, my first question is what can we expect from the Dr. Falk interim analysis? Specifically, can we increase patient number or make any other adjustments to their study?

Dr. Bobby Sandage

Management

Yeah. The short answer is yeah. The independent data mark still has the same broad mandated, had at the first interim analysis. However as you know we’ve had many discussions about the assumptions that in the modeling that we get. And we believe there is a very good chance the study will stop at the -- if what they saw at the first interim continues, the study could stop at the -- this next interim analysis. But they have the -- still the broad mandate stocking for futility, changing the arms or adding patients to the study that’s all possible. Our assumption is that given the precision that was offered to the companies in their recommendation than it’s a good chance. We will stop with a positive finding.

Boris Peaker - Oppenheimer

Analyst

Okay. That’s very helpful. Now, on TSO and multiple sclerosis, I think we haven’t talk much about that in a while. I just want to know what can we expect for the buy market data from the HINT-2 study or when specifically can we expect that?

Dr. Bobby Sandage

Management

So, we understand the Dr. Falk has completed enrollment. So he has around 21 patients now total you add in the five and additional 16 approximately. We -- the patients are being treated for 10 months. So, we are expecting data sometime probably the early prog of 2014 from that trial.

Boris Peaker - Oppenheimer

Analyst

Right. And my last question I think it’s probably more directed to Lucy as you mentioned that in some of the investigator response in trial you guys give grants. I just want to get a sense of how much are we talking about here, let’s say, over the next year in 2013 or whatever reasonable time period you would like to use?

Dr. Bobby Sandage

Management

But I will take that, Boris. These are very nominal grants because most of these sites are getting outside funding. And so if they need to cover some small pieces of the cost of the study we’re offering grants to help on manage the cost of an IRB and the cost of particular tool from measurements that sort of thing. These are nominal cost. The most expensive piece which is easily managed by us is the supply of the TSO.

Boris Peaker - Oppenheimer

Analyst

Okay. You give like a cap in the period of year. It’s under $1 million or under some…

Dr. Bobby Sandage

Management

Way under a $1 million.

Boris Peaker - Oppenheimer

Analyst

Okay. Well, thank you very much for taking my questions.

Dr. Bobby Sandage

Management

Sure. Thank you, Boris.

Operator

Operator

(Operator Instructions) Our next question comes from Megan Dow of MLV & Company. Please go ahead. Megan Dow - MLV & Company: Hi, everybody and thanks for taking my questions and congratulations on moving forward.

Dr. Bobby Sandage

Management

Hi, Megan. Thank you. Megan Dow - MLV & Company: Hello. We are just -- I'm hoping that you have a little bit more CNDO-109, how you are thinking about enrollments and how the screening for these patients is going to be underway. It looks like its pretty restrictive first, how much of these characteristics these patients mean to me and now you’ve talked for some of the physicians at these places fair with their input?

Dr. Bobby Sandage

Management

Yeah. In fact, the 10 sites that we are selected to participate or selected not only for their expertise in this particular area but they have the patients that we want. We do need patients and complete remission reliant within a certain period of time. And so the recruitment is going to be a little bit tricky but preliminary feasibility work with the sides, we think that -- in fact we know from the first few sides that we ready to go. They have patients that they can start screening literally any day now as soon as we are ready to pull the trigger with the sale processing fees and it will happen before the end of this month. Megan Dow - MLV & Company: Okay.

Dr. Bobby Sandage

Management

But… Megan Dow - MLV & Company: Great. And do you have any estimates for when those some enrollment would be happening?

Dr. Bobby Sandage

Management

Well, it’s a little tricky to predict that because this is a dose escalation protocol. So you dose the first patient. You have a number of weeks that you have to wait, see how they tolerate it and you get to dose two more and if that’s tolerated and then you can go up, if you don’t then you have to expand it. So, it’s been little bit tricky. We think we’ll have some idea about the tolerability at least through the first couple of cohorts maybe our three cohorts by the middle of next summer. We will see at maybe third quarter. And… Megan Dow - MLV & Company: Okay. Perfect.

Dr. Bobby Sandage

Management

And so we will see. Megan Dow - MLV & Company: Great. Thank you.

Dr. Bobby Sandage

Management

You are welcome.

Operator

Operator

(Operator Instructions) I'm showing no further questions and I’d like to turn the conference back over to management for any closing remarks.

Dr. Bobby Sandage

Management

Thank you. And just again I want to thank everybody for participating and listening in. If you have any follow-up questions, of course, you can reach out to any of the management team here. We’ll be glad to try and answer any one-on-one. Thank you very much. Thank you, Operator.

Operator

Operator

Ladies and gentlemen, this does conclude today’s conference. You may all disconnect. And have a wonderful day.