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MannKind Corporation (NASDAQ:MNKD)

Q1 2010 Earnings Call Transcript

April 30, 2010 9:00 am ET

Executives

Matthew Pfeffer – Corporate VP & CFO

Hakan Edstrom – President & COO

Peter Richardson – Chief Scientific Officer

Alfred Mann – Chairman & CEO

Analysts

Simos Simeonidis – Rodman & Renshaw

Keith Markey – Griffin Securities

John Newman – Oppenheimer

Tom Russo – Baird

John Ledroy [ph] – Huppelin [ph]

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation first quarter 2010 conference call. At this time, all participants are in a listen-only mode. Later, instructions will be given for the question-and-answer session. (Operator instructions) As a reminder, this call is being recorded today, April 30th, 2010.

Joining us today from MannKind are Chairman and CEO, Alfred Mann; President and COO, Hakan Edstrom; Chief Financial Officer, Matthew Pfeffer; and Chief Scientific Officer, Dr. Peter Richardson.

I would now like to turn the call over to Matthew Pfeffer, Chief Financial Officer of MannKind Corporation. Please go ahead.

Matthew Pfeffer

Good afternoon and thank you for participating in today’s call. I will summarize our financial results for the first quarter of 2010, as reported earlier today. Next, Hakan and Peter will provide an update on key events. 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 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 Exchange Act of 1934.

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, April 30th, 2010. MannKind's management undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

Let us start with the financials. For the first quarter of 2010, total operating expenses were $40.6 million, compared to $57.8 million for the first quarter of 2009, $55.8 million for the fourth quarter of 2009. R&D expenses were $30.5 million for the first quarter of 2010 compared to $42.9 million for the first quarter of 2009, and $43.1 million for the fourth quarter of 2009.

The decrease in R&D expenses for the first quarter of 2010 compared to the same quarter in 2009 was primarily due to decreased costs associated with the clinical development of AFREZZA as we filed our NDA in March 2009. The decrease in R&D expenses this quarter from last quarter was primarily due to the recognition of $12.8 million loss on disposable fixed assets last quarter, fourth quarter of 2009.

General and administrative expenses were $10.1 million for the first quarter of 2010 compared to $14.9 million for the first quarter of 2009, and $12.7 million for the fourth quarter of 2009. The net loss applicable to common stockholders for the first quarter of 2010 was $44.7 million, or $0.40 per share based on a weighted average of 113.1 million shares outstanding, compared with a net loss applicable to common stockholders of $59.4 million, or $0.58 per share based on 102.0 million weighted average shares outstanding for the first quarter of 2009.

Our cash, cash equivalents and marketable securities at the end of the quarter totaled $31.5 million which compares to $32.5 million at December 31st, 2009, and $30.2 million at March 31st, 2009. Our cash on hand and remaining credit facility from Al amounted to $176.5 million as of March 31st, 2010. Our cash burn is consistent with prior quarter, with $41 million expense in Q1 compared to $39.1 million in Q4 of 2009. With our cash on hand and the $145 million still available under the credit facility from Al, we believe we will be able to fund our operations through the first quarter of 2011.

We are in the process of accessing our operational plan for the balance of 2010 in order to finalize the extending our cash runway program in 2011. One additional comment, earlier today, we filed the shelf registration covering up to $200 million worth of securities. Currently, we have no plans to do an offering. We wanted to have the estimated filing in the event that an opportunity would arise, such as financing or a strategic transaction, which would be in the company’s interest to issue debt, equity or warrants.

I would now like to turn the call over to Hakan Edstrom. Hakan?

Hakan Edstrom

Thank you Matt. Good morning. The follow-up [ph] on what you just heard from Matt is important to recognize that we have focused a lot of attention towards expanding the cash runway. The AFREZZA spending is limited to activities that will ensure a high quality of submission of the amended NDA and hopefully a recently prompt regulatory approval. We are also looking at all other programs in order to find new savings and ways of deferring expenses.

Peter will say more about the regulatory matters in a moment, but I do want to address one question that comes up from time-to-time. As you may remember, one of the items that held up the timely FDA feedback to our NDA submissions was an uncompleted inspection of the manufacturing facility in France. While I am happy to report that our supply facility has now been inspected with a successful outcome. So, please that item is now off the critical path.

While AFREZZA is the lead product for our company and the reasons for the investments community attention, we do have a couple of other projects in development with rather compelling opportunities. Both our cancer immunotherapy and cancer drug programs recently achieved significant data milestones. That encourages us to continue the development. However, given our need to see AFREZZA through the remaining period of regulatory review, we have decided to seek collaborative or partnership opportunities for our cancer programs at this time, rather than wait until a future value inflection point.

Our initial outreach efforts have demonstrated a clear interest in these programs, and we are encouraged about these potential opportunities. Also, let me make a few short comments about AFREZZA partnership activities. We are still in continuing contacts with potential global partners, some of which have been included in our preparations to meet with the FDA, but we do not expect engaging any detailed discussions or negotiations until at least after the meeting with the FDA when all parties will have a better understanding with the process and timeline going forward.

And with those few short comments, I would now like to turn the call over to Peter. Peter?

Peter Richardson

Thank you Hakan. I would like to concentrate today on giving an update on the focus we have made in preparing response to the Complete Response that we received last month. As we indicated at that time, we believe the questions raised to us by the agency can be answered based upon the data we have available and the studies that we have completed in recent months.

Shortly after the receipt of the Complete Response letter, we requested an end-of-review meeting with the FDA. The agency granted this request and has set a meeting date in June. The greeting package which will be sent to the agency in advance of the meeting almost ready to go and will present new information that’s best as the agency’s questions and that was not available at the time of the original NDA or during review. The response would be based upon our decision to launching our second-generation inhaler and the excellent results that we have seen from our test of this innovative device in the laboratory and in clinical studies

We will present very clear data from our recently conducted bioequivalent study, which compared our second-generation device which we refer to as Dreamboat with a device used in our long-term clinical studies known as Medtone Model C. In this study, we have concerns that we can achieve pharmacokinetics profile, which is essentially indistinguishable between the two devices. But using only a single inhalation with the dose, and that 30% reduction in the amount of insulin powder in the near cartridge compared with that which was necessary in the original device.

The protocol we have used is that which we had previously agreed with the agency, and we will fully address the questions raised in our Complete Response letter around the assay methodology in Study 138, the bio equivalency study that which Medtone Model D to Model C. The generation two device also allows us to address the questions of product labeling that we raised in the Complete Response letter. Specifically, the cartridges and packaging will meet the FDA’s requirements of product identification and dosing, as well as being able to label the product in insulin-equivalent doses as requested by the agency and preferred by ourselves and prescribers.

We have also completed studies with clinical experience with the second-generation product in using volunteers and in patients with diabetes that concerns the device performance well in the clinic. We have been able to examine and test several hundred devices in our laboratories following the use by patients by two weeks. Anticipated usage periods in our proposed label for the new device and without the need for cleaning of other complexities required for the first-generation inhaler, which have been proposed for use for one year.

We are available to do this because of the major improvement in the device manufacture ability and the significant reduction in the cost of goods for the inhaler. In addition to the technical questions, you will no doubt recall that we have been asked to discuss the so-called clinical utility of the product on the basis of currently available data. Because of the rather unusual wording of the request, we saw clarification in the agency and replied with the following, and I quote from the email.”We are basically asking you to clarify where AFREZZA fits in the treatment armamentarium to diabetes," language very similar to that which I use at our update last month.

In that regard, we have been following up on additional analysis with explored use of AFREZZA against other therapeutic agents. That’s just the data that was collected in our large long-term usual care study, (inaudible), which was presented in the initial NDA as primarily a safety study. The way the HPA wanted to see was follow carefully for two years in approximately 600 Type 1 patients and 1,500 Type 2. The pre-specified analysis across the groups as a whole showed comparable reductions in HbA1c dosage usual care regiments in both Type 1 and Type 2 patients, and meet the criteria for non-inferiority.

In addition, the detailed sub analysis we prepared looking at the various subgroups of therapies comprising usual care will help us in describing clinical utility. In addition, we have recently completed Study 117, and the topline results are now available. The full report will be completed into our response to the agency.

This is a four-month study in Type 1 patients, comparing mealtime AFREZZA in combination with a long-acting insulin analog versus a rapid-acting analog, again combined with a long-acting analog, widely considered to be the standard of care. The pre-specified primary endpoint of the study is to demonstrate non-inferiority and the change in HbA1c between the two groups.

In this study, we aim to ensure that fasting blood glucose was better controlled at baseline before starting treatment and our titration algorithm was more regressive than in previous studies. Based on our knowledge that we are likely to cause hyperglycemia. Although I do have the fullest analysis available, the topline data confirmed that we have met the endpoint of a non-inferior change in HbA1c and that this result is comfortably within the statistical competence interval.

We will update with full information on other endpoints when the full analysis are complete. In summary, we have been busy in preparing a response package that we believe will adequately address the questions raised by the agency and give us the opportunity to have our second-generation device reviewed expeditiously.

We would anticipate that this would be a Class IIb submission and we are still aiming to submit this response within a few weeks of the FDA meeting. I would now like to turn the call to Al. Al?

Alfred Mann

Thank you Peter, and good morning ladies and gentlemen. It is interesting how histories do often repeat itself. 20 years ago in the early days of MiniMed, Wall Street dismissed our insulin pumps in glucose sensors. Novel, Lilly and Baxter abandoned their pump programs and MiniMed was all alone. Yet we persisted, because we understood the value of that technology. In 2001, Medtronic acquired that business for about $4 billion.

Today, Medtronic Diabetes dominates a $2 billion market just for the devices. In that venture, I learnt a great deal about diabetes. And while I was certain about the MiniMed opportunity, I also recognized that the best insulins were not good enough. The persistence of the best prandial insulins, the rapid-acting analogs leads to prandial anemia and hyperglycemia. And insulin to peak sooner and with shorter, more physiologic persistence was needed.

Technosphere insulin now known as AFREZZA is just such an insulin. Its PKPD profile is certainly far more physiologic than any current prandial product. Yet the path to the market is not easy. Indeed 15 years ago, rapid-acting analogs faced this similar challenge. In the approval process, they were viewed as having no clinical advantages over regular insulin, only possible convenience because they didn’t have to be injected so long before a meal.

Yesterday, rapid-acting analog dominates the prandial insulin markets. But even so, they are still not good enough. The method of diabetes therapy is to reduce A1c. To safely reach a normal A1c, with occurring inflows, that’s an almost impossible challenge. Both prandial plunge with a current prandial product creates serious short-term risk of hyperglycemia. To minimize the risk, passing glucose is managed at excessively high levels, and those high levels match the benefits of an insulin that does not have the excessive persistence that causes the hyperglycemia.

That late post-prandial plunge offset the prandial high. So, the average can be lower than for a super ultrafast-acting insulin. After all, A1c is essentially an average of glucose levels over about three months. Only when fasting levels are reduced to near normal will have benefits when ultra rapid-acting insulin be realized, and only then will a near-normal A1c be possible to be achieved.

To demonstrate this more effectively, last year, we initiated Study 117, an efficacy study of AFREZZA arm compared to Life Pro, in which the fasting level was to be reduced to below 120 milligrams per deciliter. With the AFREZZA arm and as low would be safe with the Life Pro arm. Even though the fasting glucose levels for the AFREZZA arm in the study were substantially higher than the protocol specification, nonetheless, the A1c for the AFREZZA arm at four months clearly met the non-inferiority standard. Indeed it was actually slightly better than for the Life Pro arm.

Moreover with AFREZZA, it is possible to lower-fasting levels as well as the lower post-prandial excursion. Furthermore, there is not only less risk of hyperglycemia then with other insulin products, but there is not the weight gain there that is common with other insulins. The FDA has asked us to explain where AFREZZA fits into the armamentarium of treatment for Type 1 diabetes. Our response based in part on the news data from Study 117 will be that AFREZZA is the usual product for managing A1c and enabling lower fasting glucose levels since there is simply not the same concern about hyperglycemia as there is with other insulin products.

As you heard from Hakan and Peter, we are preparing for the meeting with the FDA regarding the Complete Response letter in early June. Our team is assembling a briefing book that will be provided shortly to the agency. Included in the response is the additional data from Study 117 as well as answers to the several other questions and observations raised in the Complete Response letter. As you may recall, our clinical trials were done with the Medtone inhaler and our plan is to launch only with the new device. Our strategy has been to obtain initial approval of the insulin platform with Medtone and soon thereafter to file a supplemental NDA with our next-generation inhalers so that approval of the launch configuration would be obtained late this year.

We sought guidance from the FDA regarding the approval path for the new device and they have reviewed and endorsed our proposed plan. All the steps and that plan have now been completed. However, given that we have received the Complete Response rather than an outright approval, we have revised our regulatory approach. Instead of the SNDA, we plan to file an amended NDA incorporating the new device soon after the forthcoming meeting with the agency.

While we cannot predict FDA actions, if it completes to review of the amended NDA and approves AFREZZA within the allotted six months, this change in strategy will still complete the regulatory review without delaying our launch that is planned for next year. However, we would not have any interim approval of AFREZZA with the Medtone inhaler. And this has several important consequences that we must now address.

First of all, as you have heard, we have instituted number of measures that cut our cash burden rates. Clinical studies of AFREZZA that’s not only critical path for regulatory approval or being postponed, we have even suspended initiation of our Phase II study of our immunotherapy regimen for the treatment of melanoma. We are continuing to look for additional areas where we can reduce the slow spending in order to extend our cash runway even longer into 2011.

Second, we are continuing to engage in partnership discussions with several pharma companies and remain open to strategic options for AFREZZA that can extend our cash position further into next year. We are exploring several additional opportunities, but there is nothing to report at this time.

Third, we have initiated an earnest effort to partner our oncology program. Because the investment community is so focused on AFREZZA, we haven’t really talked much about these programs. So, let me take you about a minute to briefly describe them to you. Our most advanced oncology program is our immunotherapy platform, MKC1106 with three therapeutic vaccines so far for the treatment of various solid tumors and melanoma. Our approach utilizes standardized off-the-shelf preparations of D&A and peptides that is designed to induce immune system to recognize and attack only tumor cells, not healthy cells.

Our compounds are aqueous sterile solutions that (inaudible) powders made using established manufacturing processes. Unlike the first-generation cancer immunotherapy products where we just approved by the FDA, MKC1106 is not custom-manufactured for each patient and does not require a complex supply chain.

The unique feature of our immunotherapy platform is that the compounds are delivered by intra-lymph node injections. The lymph node is a readily accessible deep pool of immune cells. By going straight to the source, we are able to generate a more potent and specific immune response. At this point in our clinical development program, we have administered thousands of intra-lymph node injections or infusions and consistently observed that the procedure is feasible and well-tolerated.

What gets us very excited about MKC1106 is that even in Phase I trial, we have observed significant clinical responses without the adverse consequences of today’s primary therapy. These were unexpected findings from studies designed just to evaluate safety and tolerability of the regimen. Specifically, in a study of 26 advance cancer patients to a diverse tumor types, 10 patients had a best clinical response of stable disease.

In another study, a clearly defined cohort of four of 18 patients with advanced melanoma has similarly responded with stable disease and even parts of clinical responses. At enrollment, all of these patients had essentially no hope of survival for more than two or three months. Although these are very intriguing findings, according to Conventional Wisdom, cancer therapy programs are not – I am sorry – cancer immunology programs are not partnerable into Phase III. However, our Phase I results are still very encouraging and we have already begun an outreach effort. Our goal is to perform a collaboration to fund and accelerate the Phase II and pivotal studies of MKC1106. We believe it to be an important entry in the oncology space.

Our other immunology program is MKC204, a small molecule that inhibits an enzyme known as IRE1 alpha, which plays an important role in the unfolded protein response or UPR. The UPR is an important signaling pathway that helps to restore normal function to a cell during times of cellular stress. If this stress is prolonged due to a pathological condition, the UPR trigger program cell death. There is good evidence that the UPR is inappropriately up-regulated during certain disease state such as in multiple myeloma, thereby helping the cells to survive. We have identified and compounded selectively inhibits IRE1 alpha and believe that this compound could be the basis for a new therapeutic approach for myeloma with possible further applicability and diseases related to autoimmunity, inflammation, coronary heart disease, stroke and neurological degenerative defects such as DLS, Alzheimer’s, Parkinson’s, and Huntington’s. In a gene graph model for myeloma, we have observed that our compound inhibits tumor growth.

We are now ready to initiate the toxicology and other preclinical studies that will enable us to file an IND. We appreciate the early support of this program for the Multiple Myeloma Research Foundation, which has contributed $1 million to this development effort. Although MKC204 is a very early-stage product, we are already seeing considerable interest from potential partners. We believe our progress is significantly ahead of others and also that we will have substantial patent protection.

Our goal is to collaborate on the further development of MKC204, while leveraging our considerable expertise in the UPR field to discover new opportunities to down and up-regulate this important pathway.

In summary, our R&D and business development groups are engaged in a number of exciting pipeline activities. Our immunotherapy and other pipeline products using our proprietary technology are exciting and may create significant value. However, our primary commitment continues to be for AFREZZA and the Complete Response letter has mobilized us on multiple fronts. The resulting delay in approval of AFREZZA will unfortunately forces a slow progress in our other pipeline products. But we recognize that our priority must be approval of impressive. Our clinical and regulatory teams are preparing the work with the FDA to address these questions and we believe we are well positioned to satisfy the agency.

Our entire team is confident that AFREZZA will become a major tool in the battle against the global diabetes epidemic, the most significant health challenge facing the world today. Now, let us invite your questions. Operator?

Question-and-Answer Session

Operator

(Operator instructions) Our first question comes from Simos Simeonidis with Rodman & Renshaw. Your line is open.

Simos Simeonidis – Rodman & Renshaw

Good morning. Thanks for taking the questions. I have a question about the clinical utility comment that Peter made, I am still to be honest a little confused still, where else could AFREZZA fit in the armamentarium, it’s a prandial insulin, so it would be potentially trying to replace other prandial insulins. What do you think is the confusion, is it do you think the way you propose that AFREZZA is used or is that a confusion on their end, could you help us understand that?

Hakan Edstrom

Yes, I think that we – I don’t think this is confusion, we understand well, prandial insulin should be utilized in patients with diabetes in both Type 1 and Type 2 patients. The questions really are how do we apply this, I think in Type 2 population where it would be showing the greatest benefit and the minimal risk and there we have as you know very strong data in Study 102, which is demonstrated with a more physiological insulin, such as we have. We can achieve a significant learning in HbA1C comparable to that seeing with (inaudible) significant target to actually compare again, most contents in therapies have only been able to match that and do better with significant increases in hyperglycemia, and we see all that hyperglycemia event in that study. We also see no weight gain which is the usual problem for Type 2 patients, in trying to achieve prandial therapies and using them well.

So, I think that the discussion has to be how do you use a prandial therapy and how do we take advantage of the opportunities afforded by apparently the lasts hyperglycemia and less weight gain and also how do we bring this into, the only patients with Type 1 diabetes, well as you know, in Study 9 [ph], non-inferiority. So, I think the data was not as robust as we would have want that, but Study 117 where we have really pushed more aggressively in the titration regimen, and they are very successful there, we are very pleased with the data that we are seeing, and I am encouraged, and I think that will fall a very important part of our response in terms of how this positions for patients with Type 1 and Type 2 diabetes.

Simos Simeonidis – Rodman & Renshaw

So, do you think?

Alfred Mann

Let me just add to question, a point if I may. Simos, as you are familiar with the early data that we got on the small trial of MKC119, remember that the agency is only interested in programs where we have a significant trials that can be incorporated into the label, and while we have shown that AFREZZA is very useful early in the treatment of Type 2 diabetes before insulin, the fact is that, that won’t be part of the initial label.

Simos Simeonidis – Rodman & Renshaw

I see. Okay. A question for Peter again on the 117 study, do you have the topline numbers on the primary endpoint in terms of HbA1C reduction, and confidence intervals where we use?

Peter Richardson

What I have said is that we have seen the topline data, it is actually very hot off the first, because that’s what we completed very recently. We see non-inferiority versus the prandial regimen that we compared against. Both arms had relentless insulin glargine as the background insulin. Those confidence intervals lie comfortably below the 0.4 margin and actually we are very happy with what we are seeing in terms of the HBbA1C results. We will report more as we got a bigger picture, and I think we have entitled with certain numbers, but I think that we are confident around the numbers that we have seen so far.

Simos Simeonidis – Rodman & Renshaw

And one final question, I don’t know if I heard this correctly, but are you saying now that patients will be getting a new inhaler every two weeks versus once a year?

Matthew Pfeffer

Yes indeed, that’s actually one of the major advances, a dream in our opinion. The cost reductions are very significant in terms of the simplification and manufacturing in a number of components and the markets we use. With Medtone, there was a requirement to take the mouthpiece out and wash that out. And the device Dreamboat is actually so simple, that you don’t need to do that. And most inhaler products is a little bit of devices that are usually changed around about every month. Patients really like the idea of having a device that they can use and then discard and replace with a nice clean one at that time. And that’s something that we believe is a major advantage to all the product as we move forward. And so, that again is a part of our strategy in trying to deliver about to patients.

Simos Simeonidis – Rodman & Renshaw

And you are saying that the cost is actually lower despite the fact that you will be using 24 devices a year versus one?

Matthew Pfeffer

Actually works out low, yes.

Simos Simeonidis – Rodman & Renshaw

Okay, all right. Thank you.

Operator

Keith Markey with Griffin Securities, your line is open.

Keith Markey – Griffin Securities

Good morning and thank you for taking my questions. I was wondering if you would consider partnering AFREZZA on a geographic basis, perhaps carving out the US and Europe from other regions?

Hakan Edstrom

Well, what we have said, certainly our preference is for a global partnership, but there are certainly parts of the world that may be of lesser significance overall, but still could be significant areas where diabetes is a major disease kind of playing the country. So, yes, we are not excluding those opportunities still, carving them under the purview of a global partnership.

Keith Markey – Griffin Securities

Okay. And so, you would look for a partner who is capable of carrying the data forward that you have already accumulated and perhaps adding to it on their own?

Hakan Edstrom

Yes, that could be an option.

Keith Markey – Griffin Securities

Okay. All right. I will jump back into the queue. Thank you.

Operator

John Newman with Oppenheimer, your line is open.

John Newman – Oppenheimer

Hi guys, thanks for taking the question. I am just wondering, a couple of questions. You announced that you made a shelf balance for $200 million this morning and you talked a little bit about it on the call. I am just wondering should we expect that you would effectively draw your credit line down to zero before you think about raising additional cash? I know you have talked about some cost reduction, but it looks like you have burned about $40 million in the first quarter. And in terms of conversations that you have had with the FDA regarding the REMS program, what are those, I mean like, what are the types of safety issues that the FDA wants to discuss and how do they think that those should best be approached?

Matthew Pfeffer

Let me start with the first part of your question, John, this is Matt, and I will turn the latter part over to Peter on the REMS program. Yes, we were in the process of reducing our burn to extend the cash runway and the expectation should be that we continue to draw an outline rather than to do a financing anytime soon. We did file a shelf, it’s a matter of good corporate housekeeping, but don’t have any plans to do anything with that, it’s just there. So, once the SEC completed the review which usually takes at least a month, it could be there if we needed at some point in the future, whether it be for financing or some sort of strategic transaction. So, we are just leaving our options open. But yes, you should assume we will continue to draw an outline for the foreseeable future.

But again, there has been a lot of focus on cost reduction plan, I hope you will see that continuing in the future quarters. And with that, I will turn it over to Peter.

John Newman – Oppenheimer

Okay.

Peter Richardson

John, we had two real sessions with feedback with the agency regarding the REMS program. If you remember, we had actually proactively suggested a REMS program for this at the time of the submission, I think that’s perfectly a normal thing to do with a product at this stage we try anticipating that we would have a REMS dialog with the agency. And basically at the end of last year, we have acceptance with our REMS proposal with largely an agreement without which the agency was looking for, and in the Complete Response letter again, they reiterated that the REMS discussion is not complete, that the proposals have been made, which primarily look at how do we ensure the safe use of the product using medication guide, ensure that this is prescribed appropriately. And in particular inviting those patients where we don’t want the bullet to be used, which would be those patients pre-existing with severe lung disease.

And also in terms of how we understand the longer-term pulmonary function, and the requirements of pulmonary function testing, I think that’s likely to be an area in terms of that and how we follow that out, but otherwise, there hasn’t been anything in the event of safety areas or concerns, which we found they would be ensuring.

John Newman – Oppenheimer

Okay. And just one quick follow-up, in Study 117, it looks like you were measuring the change in Hemoglobin A1c from visit 5 to 14 and that was a 16-week study. It looks like in 009 study for Type 1, you were looking at the change versus the baseline. I am just wondering why you measure the change in HbA1c beginning at visit 5 versus beginning a visit say, one or two in that study?

Peter Richardson

It’s a very good question. And it’s quite simple, in 117, we actually employed a running period. We wanted the patients to have the best fastening control. So, we are looking how we optimize the base. If you look at the FDA guidance this well-intensive, they tend to recommend (inaudible) diabetes. The 9 study which was designed actually sometime ago, I think one of the learnings was that we would have done better to how to run in period with that, and they are pleased that we chose to take our approach and that’s the reason for that comparison.

John Newman – Oppenheimer

Okay. Thanks.

Operator

Tom Russo with Baird, your line is open.

Tom Russo – Baird

Good morning. Thanks for taking the question. The first one, I just wanted to revisit the comment that you guys are filing an amended NDA versus a response to the Complete Response letter. Is that indicating any change in the approach, or is that just different ways of saying the same thing.

Matthew Pfeffer

Exactly. It’s different ways of saying the same thing. The only way you can actually submit a Complete Response is to file an amendment to the original file or file a completely new NDA. So, we are also following up in terms of the agencies now giving us a complete response of that review. So, the finality is that we now have the opportunity to have a discussion with them, with our briefing package, they will go down. We have that meeting in June, and we anticipate being able to amend our NDA. We have a date to file in-house. So, it’s not a complete review of the new dossier. Unless we said, we would anticipate that this would be a Type 2 resubmission.

Tom Russo – Baird

Okay. And then you referenced earlier an email interaction with FDA and I was wondering if those part of that or any other interaction may indicated any agreement or concurrence with the approach of changing the device at this stage of the process?

Peter Richardson

No, I mean, we haven’t indicated that.

Matthew Pfeffer

Remember that as this is a straightforward technical discussion around bio equivalence and weather the device performs technically in the same way that the Medtone did better, on a day-to-day in terms of showing that. So, we are anticipating just as we did when we talked to the Medtone to how we would make that substitution in terms of an SNDA, the vehicle should pass for this, is really quite well placed and we have the opportunity by using careful bio equivalence on the date we have talked about today showing that we demonstrated that I think very clearly we will go a long way in terms of how we can look at that. And then it’s around how we can show the technical aspects of the device performance, how it looks in clinical utility testing which we have done outperforming that. So, we have got a discussion with the agency and based on the information that we have had, previously how we make that substitution, we are confident that the agency will see that forward.

Tom Russo – Baird

Okay. And you do meet with FDA in June, is it all three divisions, or is it just the lead division that you have to meet with?

Peter Richardson

Yes, you are quite right, it involves quite a number of divisions, because we have the device, (inaudible) as well. So, yes, there is a lot of interest at the agency with this on this. I think that’s one of the challenges in terms of scheduling the meeting. We maybe anticipated a little earlier, but I think they had a lot of people pulled together for this meeting. Yet there is a lot of people we need to work with in terms of standing this, I would say a lot of interest, because the device itself is very exciting device.

Tom Russo – Baird

Okay. And then my last question, and I will hop out. Can you just I guess confirm at this stage which of the trials are going to be considered because pivotal trials, I know there has been a lot of discussion of Study 117, and then also the last time that FDA kind of reiterated its agreement that a 0.4% difference in A1c is acceptable?

Peter Richardson

Yes, the 0.4% is actually in the guidance and just in terms of the diabetes, that will be a good reference to look at in terms of where the 0.4% margin is exactly. And in terms of, the word pivotal is actually one that’s been around, I am looking adequate and one can feel that it’s here, which we have settled. Clearly, our approach is that 117 is not a good well-controlled study, which is very important in the sense of having additional data for the Type 1 indication, but also overall in terms of again showing the comparison of a prandial basal regimen in patients with diabetes, which is widely applicable. Because you have asked a question in terms of clinical utility, that gives us a great opportunity of showing some of the (inaudible) watching us – we had actually already started presenting some of these in terms of the Type 1 and Type 2 patients and the usual cast setting where we can unlock [ph] the data and exploit against various different treatment regimens and again provide some useful insight in terms about, and those will be very supportive data.

So, we have the pivotal as you said in terms of Type 3 studies and we are having additional data with the Study 117, which I think will be adequate and well controlled for purposes of evaluation and the detailed analysis that we are now able to make within the framework of the question for OPO.

Tom Russo – Baird

Okay. Thank you.

Operator

John Ledroy [ph] with Huppelin [ph], your line is open.

John Ledroy – Huppelin

All right. Thanks for taking my call. Just a couple of questions first on 117 trial. If the groups had different fasting levels on entry or at week 5, is that really an apples-to-apples comparison, and then also, are there any lessons from that trial that may be about Type 2 diabetics.

Peter Richardson

I didn’t say they have different levels of entry. And what we are interested in is trying to optimize both groups as well as you can in terms of the running period to optimize the basal insulin and then the trial compares AFREZZA, which is space short-acting compared with the rapid-acting analog. I see at the end of the study over that period one that we have on the fasting, and those will be very interesting data to see. And if our hypothesis and I think it’s one which we have seen lot of stages over the case, we should see a lower fasting at the end of the study whereas we started with maximum.

John Ledroy – Huppelin

Okay. And then in terms of the CV requirements for diabetes drugs, what was your relative risk in that pooling, maybe the upper limit there?

Peter Richardson

I can’t remember, we came well below the –

Alfred Mann

1.01, Peter, it’s 1.01.

Peter Richardson

Thank you Al. Al remembers the numbers, I just remember the importance of that, we actually came well within the, what would be something that I think we have given to that one. We have questions from the agency regarding the cardiovascular risk of insulin, which I think is not an issue.

John Ledroy – Huppelin

Okay.

Alfred Mann

I think a point – the FDA guidelines for those of you who aren’t familiar with this, the 1.3 as being acceptable, and we are at 1.01. If you are at 1.80, you have to do additional studies, but we are at 1.01 essentially no effect on cardiovascular matters.

John Ledroy – Huppelin

Okay. And then in terms of partnership, do you think that something that will need a finalized label, or you think that’s something that could happen prior to the final label?

Peter Richardson

We are in continuing discussions as I mentioned. Actually, we have collaborated with some of the key potential partners here, even with regard to our response to the Complete Response letter. So, I would say that certainly it’s an opportunity even prior to a complete label.

John Ledroy – Huppelin

Okay. Great. And then just last one, so with clinical utility, I know sometimes panel address that, for expert panels, are you guys still assured that you are not going to need a panel?

Alfred Mann

There is no panel scheduled if requested or required by the FDA.

Peter Richardson

Let me just say, John, that you are right in terms of the panel can be called at any time. We have had clear instructions from the agency, that’s not their intent. I would be delighted to have a panel to discuss the data that we have and to present that in that sort of forum [ph] would be a very exciting opportunity to give a very good overview of us and the data that we have.

John Ledroy – Huppelin

Okay. And then just one last one, do you know what you are going to present at the ADA meeting?

Peter Richardson

When the abstract of that turns out, you will see that we are busy in terms of preparing some exciting abstracts.

John Ledroy – Huppelin

Okay, great thanks.

Operator

(Operator instructions) At this time, we have no further questions. Thank you for joining us today, and I will turn the call over to Chief Executive Officer, Alfred Mann for final comments.

Alfred Mann

Thank you ladies and gentlemen for joining us today. I expect that the next announcement from us will come when we submit the amended NDA to the agency. Of course, we will also update you at our next quarterly call. Thank you again for joining us.

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Source: MannKind Corporation Q1 2010 Earnings Call Transcript
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