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MannKind Corporation (MNKD)

Q4 2007 Earnings Call· Mon, Mar 24, 2008

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Transcript

Analysts

Management

Cory Kasimov – JPMorgan Annable Saminy – UBS Thomas Russo – Robert W. Baird Michael Tong – Wachovia Securities Analyst for Salveen Kochnover – Jeffries & Co. Elizabeth [inaudible] – Piper Jaffray

Operator

Operator

Welcome to the MannKind Corporation fourth quarter 2007 conference call. (Operator Instructions) Joining us today from MannKind are Chairman and CEO, Alfred Mann; President and COO, Hakan Edstrom; the Chief Financial Officer, Dick Anderson; and the Chief Scientific Officer, Peter Richardson. I would now like to turn the call over to Dick Anderson, Chief Financial Officer of the MannKind Corporation.

Richard L. Anderson

Management

I will summarize our financial results for the fourth quarter of 2007 as reported earlier today. Next, Hakan and Peter will provide an update on key accomplishments during the past year. Finally, Al will comment on the current situation and our outlook going forward. We will then open up the call to your questions. 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 actual results could differ from these stated expectations. For factors which could cause actual results to different from expectations please refer to the reports filed by the company, with the Securities and Exchange Commission, of the Securities Exchange Act of 1934. This conference call contains time sensitive information which is accurate only as of the date of this live broadcast, March 4, 2008. MannKind’s management undertakes no obligation to revise or update any statements to reflect events and circumstances after the date of this call. Let’s start with the financials. For the fourth quarter of 2007, total operating expenses were $79.1 million compared to $79.8 million for the fourth quarter of 2006, and $75.6 million for the third quarter of this year. R&D expenses were $66.8 million for the fourth quarter of 2007 compared to $59.7 million for fourth quarter of 2006 and $64.8 million for the third quarter this year. The increase in R&D expenses was primarily due to increased manufacturing costs, including clinical supplies for Technosphere Insulin offset in part by lower purchase services in the associated clinical development program. General and administrative expenses were $12.3 million for the quarter, compared to $12.1 million for the fourth quarter of 2006, and $10.7 million for the previous quarter. G&A expenses increased for the fourth quarter of 2007,…

Hakan Edstrom

COO

We previously said that 2007 was going to be a quiet year in terms of outward signs of progress but not in terms of actual accomplishments. From my vantage point, I believe that MannKind’s performance this past year was extraordinary. I am very proud of the many significant accomplishments achieved by employees during 2007 and let me share some of these highlights. We executed a large and challenging Phase 3 clinical program for TI involving over 300 sites in dozens of countries, with many hundreds of physicians. Our pivotal trials remain on schedule for completion later this year and I will ask Peter to provide more information about this program in a moment. We initiated our first clinical trial program for Technosphere GLP-1, our second program candidate for the treatment of diabetes. In this study we observed a format of kinetic profile for GLP-1 that suggests our platform also may have broad applicability to a variety of signaling hormones. We completed two carcinogenicity studies Technosphere Insulin and RFTK carrier that delivered clean results. And these studies will also support fully our own Technosphere platform products. We funded a second R& D for cancer and immunotherapy product and trials should get underway this summer. We moved forward with ambitious construction project in Danbury, Connecticut. The expansion of the manufacturing facility is scheduled for completion this summer. The project is on time and below budget. And we put in place a long-term agreement with a supplier of insulin. Our Danbury call to management systems have been certified as compliant ISO9001 and ISO13485. We raised $250 million through an equity financing, we also put in place a $350 million credit facility that would fund us through the end of 2009, and we secured external funding to help support our drug discovery programs that…

Peter C. Richardson

Management

As we have highlighted, we expect to announce later this year the results from our three critical TI trials as well as the Study 103. I will now provide an overview of the several trial designs starting with the pivotal efficacy trial consisting of the 009 and 102 trials. Our [inaudible] program is well designed to support the use of TI in a broad patient population comprising type 1 and type 2 diabetics. In comparison to the use of TI in cranular insulin and top base background insulin, such as rapid acting analogs in type 1 and fixed mixtures in patients with type 2. Turning endpoint in the pivotal efficacy studies of 109 and 102 is non-inferiority in changes in HbA1c baseline. The second endpoint looking at postprandial glycemic excursion [7.03] profile is well within the assessments of hypoglycemia. In addition, we’ve incorporated studies to evaluate the number of quality of life measures into this program. The other pivotal trial is the 030 trial which is two-year pulmonary safety trial. The primary endpoint to this is change in FCD1. The second endpoint is changes in SBC total lung capacity and DLC0 change in L1C from baseline as well as hypertensive hypoglycemia and other useful safety metrics. The 09 Interferon Trial have been conducted under special protocols assessments with the FDA and the Y2 objectives is virtually identical to 09 so we don’t anticipate further requirements from the agency. Moreover, all of our pivotal trial designs are in line with [inaudible] FDA guidelines, which are at issue recently. Studies 1 and 3 and 09 will be completed by midyear in some patients in both of these will be answering our follow-up observational study after treatment study 126. Pulmonary function will be evaluated in patients in both these studies and will releasing…

Hakan Edstrom

COO

I now want to provide some additional details regarding our manufacturing expansion product and our commercial readiness activities. We are approaching an inflection point in 2008, when our corporate efforts will transition from supporting the development of TI to supporting the commercialization of TI. And in order to make this transition we must implement a number of new business processes, systems and supplier relationships. The $250,000 expansion of our TI commercial manufacturing facility is progressing according to plan and our experienced team in Danbury is expecting a physical completion in the third quarter of 2008. Currently the project is transitioning from construction to commissioning and scale up which will take place in the second quarter of 2008. Preparations for the FDA pre-approval inspections are ongoing. One example of our progress in this area was our ISO9001 and ISO13485 certifications in October of last year. Additionally our compliance order group is working closely with key suppliers to ensure their readiness with commercialization and pre-approval inspection. Based on rigorous manufacturability assessments we have finalized the commercial version of our inhaler which offers functional ease and benefits to our patients. It is suitable for automated assembly and effectively manages supply costs. And most recently we initiated a technology review as part of our lifecycle management effort to identify cost reduction opportunities to be implemented after product approval. And finally, with regard to our partnership activities, we are already in discussions with potential partners with the goal of reaching a collaboration agreement for TI with a partner who shares all commitment and vision for improving the lives of patients with diabetes. We remain focused on selecting the right partner who can provide the key elements that will set TI apart from other forms of diabetes therapy on the market today. With that review I now would like to turn the floor to Al Mann, our Chairman and Chief Executive Officer.

Alfred E. Mann

Management

I am certainly pleased with our continuing progress with TI and with our readiness plan for commercial operations. As Hakan discussed 2008 is becoming a very important and exciting year for MannKind as we begin to see the results of our Phase 3 trials and prepare to submit our NDA. Dick reported that our October financing package will now provide funding through the end of 2009 which is one quarter longer than previously indicated. Our commercialization operations are moving forward and remain on schedule. We continue to execute according to plan. Now I would like to comment on our strategy going forward. We are committed to establishing Technosphere Insulin as the preferred real time therapy within the broad population of people with diabetes. Let me say once again that I believe that Technosphere Insulin is the most effective means ever created to control cranial glucose excursions and to do it safely. We believe these vantages that I have repeatedly described in terms of safety, efficacy and convenience of the Technosphere Insulin system as compared to other therapies will enable us to significantly penetrate the broad diabetes population not just the insulin using market. Importantly, Technosphere Insulin has the potential to prove really valuable in treating type 1 and the entire spectrum of type 2 diabetes, even pre-diabetes. Our target markets include type 2 patients who are currently using conventional therapies other than insulin, even including those currently using diet and exercise therapies but who are having difficulty achieving proper blood glucose control. Indeed, key opinion leaders have hypothesized that Technosphere Insulin’s unique kinetics that used in pre-diabetes metabolic syndrome could even prevent or at least significantly delay disease progression. It is thus our intention eventually to target people even before they would have started oral medications as well as patients…

Operator

Operator

(Operator Instructions) You have a question from [inaudible] - Bank of America. [inaudible] – Bank of America: On the guidance that was released a few days ago, how long is your wash out period for key trials and second are you accepting or open to relative rates of common morbidity? And then they outlined a number of lung functions that and then on that side they also mentioned about the need potentially for high-resolution temography and I was just wondering if you are utilizing that technology?

Peter C. Richardson

Management

Yes, to answer your last question, we have used high resolution CT in the studies and I believe that we are in keeping with the guidelines on all of these aspects. In terms of the wash out, my reading of that, I think you are reading in the specifics wash outs of the Phase 2 programs where we did do wash out, we have a short wash out period followed for [inaudible]. But if you look at that guidance the difficulty of washing out patients are requiring insulin is I don’t think the guidance is there. Carefully in terms of that which is applicable to insulin and that which would be more appropriate for oral hypoglycemics and those where you wash outs. So at least be careful interpreting that. [inaudible] – Bank of America: Are you assessing relative risks?

Peter C. Richardson

Management

Yes, again, that aspect we have in the program comprising over 3,000 patients, we will be looking at the [inaudible] safety readout not pre–specified co-morbidity and again if you are looking at that section of the guidance I believe that would give you indications where you are looking at claims around convention of the morbidity. [inaudible] – Bank of America: You also mentioned about special population and do you think that it is now going to be required those trials that you are running as part of the NDA?

Peter C. Richardson

Management

We have already indicated that we have a comprehensive program of Phase 1 and of Phase 3 studies in special population by treating asthma and objective airway disease as well as in terms of capacity [inaudible]. Those are all underway. We will have them ongoing and if you actually read the guidance again on those I think that the wording has been a little looser in terms of we will have patients on those treatments with those indications in RNDA at the time that we make.

Operator

Operator

The next question comes from [inaudible] – Rodman & Renshaw. Why the slightly unusual data release for the 030 data why wouldn’t press release that. What’s the thought process between holding that until you or really never making it public until approval?

Peter C. Richardson

Management

Are you talking about the 030 or the 103? I think the big long; I think you said the two-year trial would release data on submission of the NDA.

Peter C. Richardson

Management

I think there is basically timing of that will be our last is a critical [inaudible] study with 3,000 patients where we will be doing a complex database lot that first week of September through to filing the NDA in December. I’d like to concentrate in making sure the data in the NDA and the effect of the release of that information will be at the time that we are putting the entire package. I think that is why you are looking at it in those terms. [inaudible] – Rodman & Renshaw It’s just a rate-limiting step. You are not treating that data any differently is what you are telling me?

Alfred E. Mann

Management

No, no, no, it’s purely timing, Tom. You know what we have been saying all along, Tom. [inaudible] – Rodman & Renshaw I’ve very glad to see the 117 study Al and thank you for your impassioned account of it. Do you think you need those data to launch, what is really the difference between what everyone else has failed on and where you can succeed? Is that now part of the NDA? How does the timing of that come relative to a launch?

Peter C. Richardson

Management

We’ve always planned on to be available after launch. Clearly it’s not the study that will complete the timing to make the NDA submission. But now we are moving into really what I think is the very exciting part of the program which is executing some really challenging 3B and some 4 studies, this is the first of them. It’s a very aggressive design; its one which I think is really important in the position of TI and our plan is to absolutely have this available at the time of launch to support our message around that. but we have done this during time that we have had terms of executing the Phase 3 program, really so we can focus on making the NDA at the time that we said and then having this data to support launch and I think that is the optimal way of managing it. The lay of the land right now, although its very different is that pushing diabetics to normal HbA1c levels is dangerous but I understand it was attempted in a very different way, but does that color your ability to get this trial started and when I think it leaves Al’s explicit goal is to get them to normal levels. Am I clear on what I am asking?

Alfred E. Mann

Management

Yes, but I think you have to be very careful. You are referring to families to these [inaudible] studies and that study could never have produced good control. The problem that exists today is there is absolutely no way to get truly normal glucose control to any current diabetes products. Unless you can address both prandial and basal levels or fasting levels, separately, independently, you just cannot do it. And so the [inaudible] study really has some faulty conclusions. And in the fact all of the people that I have talked to, the KOLs who will look at this say that they don’t really understand or are not paying much attention to that because frankly the implications are just not supportable. So you have seen no indication that IRVs are missing at this point, they are all aware that it is very different?

Peter C. Richardson

Management

I think that we are discussing with IRV and we are moving soon and that we have a very good set of answers to those questions. You are obviously very aware in terms of the surprise factor of that year round we have a lot of discussion with opinionated in the field and I think that until we see the published results of that we have more questions than we have answers. You are absolutely right in terms of potentially this is an opportunity for us in terms of looking and saying we are sensing that exclusion in terms of optimizing the rapid, short acting prandial insulin that we will have a tool and we hope we will be able to use that. I think the 4T study as well, in demonstrating the difficulty in getting HbA1c down with conventional with rapid acting analogs again, helps us in terms of where we have to go in terms of picking our product to demonstrate the benefit.

Operator

Operator

Your next question comes from Cory Kasimov - JPMorgan. Cory Kasimov – JPMorgan: I will start with a partnership question and try to get some more clarity there and the status of ongoing discussions with pivotal TI results now just about six months away, at this point, should we be assuming that a partnership is not going to be signed until at least the initial results are available given the potential value inflection data you have provided?

Hakan Edstrom

COO

No, you cannot make that assumption. These discussions have been ongoing for some time and they certainly come with regards to evidence in regards to what they see in terms of the differentiated benefits of our product. So while certainly there are important data they are not kind of driving the pace of the discussions at this point in time. Cory Kasimov – JPMorgan: So you don’t think that you think you would get more in return if you held out and waited six months or so, until at least the initial pivotal efficacy figures are out.

Hakan Edstrom

COO

I would say that no that we have not had that indication that the results of our clinical trials from that point of view would drive a different outcome. Cory Kasimov – JPMorgan: With regard to the 103 Metformin study, this is the trial that I remember was originally supposed to have data by the second quarter and given its complexity that’s been pushed back a little bit, can you just review what is so complex about that particular study and more importantly what you hope to learn from it.

Peter C. Richardson

Management

It’s not just the complexity of the study. It’s actually the fact that these patients we have continued into the offset study and we want to look at the data in terms of the entire [inaudible] when we have the offset study complete as well. Cory Kasimov – JPMorgan: With regard to TI, Al again gave a very impassioned speech about moving this much earlier not just a big plan deal established there with type of insulin but moving this ahead into even pre-diabetic populations and I realize its very early now but in thinking about that designing long-term strategies there what type of long term outcome studies do you think you would need to design and conduct in order to actually get patients at that stage to use a therapy like this?

Peter C. Richardson

Management

Well for the pre-diabetic population I would refer you actually to the recent issued guidance which actually gives some help in terms of this first time that we have seen an approach being recommended in terms of the outcomes that we can measure and look at in there and I think that is encouraging in terms that we do have a path forward which we could start to follow. Cory Kasimov – JPMorgan: Did you submit the Phase 1 GLP-1 data for presentation of NDA?

Peter C. Richardson

Management

Yes.

Operator

Operator

Your next question comes from Annable Saminy – UBS. Annable Saminy – UBS: On the guidelines again, was there I think that I remember seeing some kind of mention that might require a very long term study of co-morbidity for these patients and can you give a little bit more color on that and if the FDA is going to come back and say we want to see longer studies.

Richard L. Anderson

Management

My reading of the guidance there is that if there is safety signals that emerges then maybe that requirement or if you are going to specific [inaudible]. Clearly as the safety data evolve any signals that would normally be expected about direct with this [inaudible] requirements for studies. I have no indication of that being the case at present time but I think that is what the guidance would show something. Annable Saminy – UBS: Are you actually measuring the co-morbidities?

Richard L. Anderson

Management

In terms of the safety outcomes as would be known for this. Annable Saminy – UBS: On the data with the special populations, are we going to be seeing any of the data releases over the course of the year before it is included in the NDA package?

Richard L. Anderson

Management

The Phase 1 data as it becomes available but I haven’t got specific guidance on the timing when that will be available its going to the cost of this year. Annable Saminy – UBS: On the GLP-1, I think I remember in the last call you had mentioned that the GLP-1 is a native GLP-1 rather than an analog. I just wanted to understand specifically what the importance of that is versus an analog,

Richard L. Anderson

Management

Yes, it is a native GLP-1 and the advantages of that are that is the naturally occurring peptide and which I think from that basis [inaudible] immensely attractive. What we are exploring is the difference, again, just as we are seeing with the Technosphere Insulin with the characteristics of the peptide action can be changed by that time action giving it a very rapid delivery by the lung enables you to do something different in terms of signaling and the clinical effects that you see because of that change in the pharmacokinetics. Now the previous thinking with GLP-1 and I believe most other companies and developments in this area extend the action profile just as with insulin the first many years we tried to extend the insulin action. Looking at those effects in terms of having the very rapid, short PK and the looking of what that will do in terms of, glycemic control and I think that you will look forward to seeing the data as related to [inaudible].

Operator

Operator

Your next question comes from Thomas Russo – Robert W. Baird. Thomas Russo – Robert W. Baird : I was wondering if you could elaborate on whether you have had any interactions with payers yet, I know you have [inaudible] program taking off and I was just wondering if you interaction with those up to this point?

Hakan Edstrom

COO

Well, yes, we certainly have a consulting group that has been working with us and looking into all of the aspects of reimbursements both in the United States and in the European arena. I couldn’t tell you specifically whom they have spoken to at this point in time but actually in about two to three weeks from now we will have their first report based on what they learn and what they have seen. So it’s certainly on our agenda to make sure that we are fully aware of requirements that they might have. Thomas Russo – Robert W. Baird : I think you mentioned earlier interest in moving another module into the Technosphere system and I was wondering if basal insulin is an application that would be of interest to MannKind.

Richard L. Anderson

Management

Yes, but that doesn’t mean that is going to be the next one going through. Thomas Russo – Robert W. Baird : Just in terms of the Danbury facility when in the process do you expect the FDA inspection to occur?

Hakan Edstrom

COO

Our preparation is such that we expect to be ready within 90 days of the findings. Our expectations is probably somewhere around May of 2009 we would expect the FDA in our facilities.

Operator

Operator

Your next question comes from Michael Tong – Wachovia Securities. Michael Tong – Wachovia Securities: On the Phase 3 and Phase 4 studies [inaudible] Humalog, how big is that study going to be and how long do you think patient enrollment will take?

Richard L. Anderson

Management

Roughly every 100 patients, its 300 in enrollment we are planning to have this study completed in time for supporting the NDA filing. We have a lot to do in terms of enrolling and I think this is a very attractive study. Michael Tong – Wachovia Securities: You are going to have it completed by the time of filing the NDA.

Richard L. Anderson

Management

By the time we launch.

Operator

Operator

Your next question comes from Salveen Kochnover – Jeffries & Co. Analyst for Salveen Kochnover – Jeffries & Co. : Has there been a common concern in your discussions with potential partners on enrollment issue in terms of a major hurdle for partnership and if so, how do we get over this hurdle? Has there been a common concern from potential partners in terms of signing partnerships?

Hakan Edstrom

COO

No I cannot say that that has been anything in common. There have been unique situations either on their side or our assessment whether they are the right partner to take us forward phase of marketing to [inaudible] partnership.

Operator

Operator

Our last question comes from Elizabeth [inaudible] – Piper Jaffray. Elizabeth [inaudible] – Piper Jaffray : On the preclinical program, first do you feel comfortable your preclinical program will meet the requirements set forth in the [inaudible] documents and then second are you going to release data from the six-month transgenic [inaudible] study?

Richard L. Anderson

Management

Yes to the first and we will have some further work on the histology and details on transgenic and when we have that we will put that into the appropriate earnings call.

Operator

Operator

There are no further questions at this time.

Hakan Edstrom

COO

Ladies and gentlemen we are grateful to all of you for your ongoing support and commitment as we pursue our mission and try to reach and exceed our goals. Thank you all for joining us today. We look forward to updating you at our next quarterly call.