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MannKind Corporation (MNKD)

Q1 2016 Earnings Call· Mon, May 9, 2016

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Transcript

Operator

Operator

Welcome to the MannKind Corporation 2016 First Quarter Conference Call. [Operator Instructions]. Joining us today from MannKind are Chief Executive Officer Matthew Pfeffer, and Principal Accounting Officer Rose Alinaya. I would now like to turn the call over to Ms. Rose Alinaya, Principal Accounting Officer of MannKind Corporation. Please go ahead.

Rose Alinaya

Analyst

Good afternoon, and thank you for participating in today's call. Before we proceed further, please note that comments made during this call will include forward-looking statements within the meaning of Federal Securities laws. It is possible that the actual results could differ from these stated expectations. For factors, which could cause actual results to differ from expectations, please refer to the reports filed by the company with the Securities and Exchange Commission under the Securities and Exchange Act of 1934. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast May 09, 2016. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this call. I now turn the call over to our CEO Matthew Pfeffer.

Matthew Pfeffer

Analyst

The first quarter of 2016 had many challenging transitions for the company but we believe that MannKind 2.0 strategy to commercialize ourselves and leverage our Technosphere platform for future growth is the right one to deliver long term benefit to patients and shareholders like. In the first quarter of 2016 our mission was to transition Afrezza back to MannKind while ensuring no interruption of supply to our users. We executed on that plan and we’re very happy to announce the return of Afrezza rights on April 5th. Also in the first quarter we completed our first licensing of the Technosphere platform to Receptor Life Sciences and we recognize that 250,000 signing fee, payment from them in our first quarter financial results. This first program milestone payment from [indiscernible] is expected in the fourth quarter as we complete initial product development milestones. I will now expand our blueprint for the remainder of the year. Building a commercial organization from a ground up is our main objective in the second quarter. Our commercial leadership team is now in-place Mike Castagna that’s head while his two key Vice President's. We expect to have a diabetes nurse educators deployed by the end of this month and we’re in the amidst of hiring a 60 to 70 person U.S. wide sales force which will be in the field by the end of June. On the Medical side, our Chief Medical Officer, Ray Urbanski is currently recruiting a VP of Medical Affairs who will deploy a team of geographically based medical science liaisons. These MSOs are charted with building relationships with key opinion leaders, professional organizations and patient advocacy groups within the diabetes market. Saleswork will support field sales activity and will also leverage our medical information capabilities including a professionally staffed call center which has…

Rose Alinaya

Analyst

Thank you, Matt. Turning now to the financials, the net loss applicable to common stockholders for the first quarter of 2016 declined to $24.9 million or $0.06 per share compared to the net loss applicable to common stock holders of $30.7 million or $0.06 per share for the first quarter of 2015. Research and development expenses were $5.1 million for the first quarter of 2016, a decline of 45% compared to the same quarter in 2015 largely due to the reduction in force and closure of our Paramus, New Jersey facility in 2015 and reduced development expenses as we transition to commercialization of Afrezza. General and administrative expenses were $7.4 million for the first quarter of 2016, a decline of 30% compared to the same quarter of 2015 primarily due to the risk and closure of our Paramus office in 2015 in addition to reduced professional fees related to strategic planning activities incurred in 2015 and lower non-cash, stock compensation expense. Product manufacturing expense was $7.5 million for Q1 2016 due to the underutilization of our manufacturing facility during the quarter. As a facility was nearly at idle but also included a loss from foreign currency translation of $2.4 million related to prepaid purchase commitments. For the first quarter of 2016, our portion of the loss sharing arrangement with Sanofi related to Afrezza was $5.5 million. The amount outstanding under the Sanofi loan facility is now $68.8 million which includes 2.8 million of accrued interest. Under the terms of this facility it is not due for repayment until August 2024. Cash and cash equivalents were $27.7 million at March 31, 2016 compared to 59.1 million at December 31, 2015. In the first quarter of 2016 as Matt mentioned we received a signing fee of $250,000 from Receptor Life Sciences pursuant…

Operator

Operator

[Operator Instructions]. And our first question comes from Adnan Butt from RBC Capital Markets. Please go ahead.

Adnan Butt

Analyst

I will ask two please. First, in terms of raising capital, Matt. How long do we wait for you to give us some more definitive strategy? Is it going to be equity debt partnership or some combination when do you think you'd be able to provide an update there? And then just secondly on your more detailed selling efforts could you tell us that for your targeted endocrinologist and high prescribing GP focused targets. How many prescriptions they write or how many patients do they see overall? Thanks.

MatthewPfeffer

Analyst

Okay, so let me try to answer the first part of that query real quickly. It's going to be a little bit difficult, I mean we've been pretty open that a large portion of our strategy is revolved around opening some international markets and doing deals as our first preference for raising money. That said we can't wait forever and if we need to do a small equity financing there device full time we will do that. I hope will be in a position to answer that question with more details and specifics very. Frankly I have to go to do it by now, that didn't work out quite the way I thought it would but it should be imminent I believe and all I can do is ask for your patience and hope you'll stay tuned. I have taken the liberty of well that we’re not speaking roles on this call for Mike Castagna, our Chief Commercial Officer or for that matter Ray Urbanski, our Chief Medical Officer. I did ask them to attend just in case there were questions that were more properly answered by them, so I will take advantage of that and have Mike answer your question about the prescribing patterns and support.

Mike Castagna

Analyst

On the number of targets we’re just finalizing territory alignments but we're pretty close over the next few days. It will be 5000 to 7000 Thirty targets and that’s really up to us to cover all 5000 or 7000 just depending on how many people we want to hire but the coverage is approximately 65% of the insulin market just to give you rough number and obviously depending on the type of prescriber some may see 30 patients a day, some may see 50 patients a day. The doc side that we’re in touch with are seeing 30 to 50 patients a day easy and so I think the top decile [ph] perscribers is probably what you can expect that we're looking at is somewhere between 20 and 50 patients today is what they are seeing.

Adnan Butt

Analyst

Okay and if I can just follow up in the same path, what do you find to be the hurdle from the parasite, so is it more getting doctorish to write more prescriptions or is it converting those prescriptions into something [indiscernible]?

Matthew Pfeffer

Analyst

I will try that question, a little bit, there is a couple of nuance in there, I don’t want to get into the call, but the first one is Medicare Part D contracts, as you may or may not know take 12 to 18 months in advance to secure. So we didn't have that opportunity to get the product back on April 5th to lock those in for '16 and '17, we’re working on closing that gap where we can so that that population were looking at a few different solutions on and see where we can get Medicare coverage we will, that takes a little bit of time just given all the regulations in that space, On the commercial side again we just got the product back about a month ago, we've been in touch with all the top players already, understand there are some opportunities but we're trying to do is really gauge how much of the volume can be accounted comfortably approved through prioritization process as opposed to trying to renegotiate existing contracts that are already out there for '16. So we will have updates on that over the coming quarter but I don't want to go into too much detail given there's a lot more detail in managed care and we have to cover -- not covered but we will have that in the near future. But I will answer one less thing on that one, we’re seeing roughly 7 out of 10 patients get approved through the prioritization process and I think that's a comforting statistic as we go back out there to see when doctors do [indiscernible] that they are getting approved.

Operator

Operator

And our next question is from Keith Markey from Griffin Securities. Please go ahead.

Keith Markey

Analyst

I had a question, I was wondering if you could elaborate a little bit on the use of the diabetes nurse educators for us?

Matthew Pfeffer

Analyst

Sure. I mean typically they're used to call on the centers who have nurse educators to provide them support. They can also be used for patient trainings and community seminars and they can be potentially used for depending how we go about our spirometry program, they can also be used for implementation in training around that.

Keith Markey

Analyst

So these could be events sort of event gatherings of patients who are new to Afrezza or thinking of join in you know using the drug?

Matthew Pfeffer

Analyst

Correct. It will be HIPAA so I think that's the key we're looking at making sure they can interact with health care professionals and patients at the same time.

Keith Markey

Analyst

And then I was wondering if you tell us a little bit about the timelines for development of the epinephrine product as we see it leverage as far as you can go, I would be happy. Thank you.

Mike Castagna

Analyst

So with the epinephrine program we are progressing with as Matt said with a couple of formulations that we will believe will be able to bring in through clinical testing, so we're looking at having a pre-IND meeting with the FDA sometime in the November timeframe with a IND filing sometime in January. Clinical phase activities will probably start sometime later in '17.

Operator

Operator

We have no further questions at this time. I will now turn the call to Matt Pfeffer for closing remarks. Well thank you all very much for your attention. We look forward to reporting progress on the sales front and working on other important developments including our pipeline, collaboration's and international expansion during the remainder of the year. We're preparing for our annual stockholder meeting in Danbury and look forward to seeing if you're able to attend. With that thank you once again.

Operator

Operator

Thank you ladies and gentlemen, this concludes today's conference. Thank you for participating and you may now disconnect.