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MannKind Corporation (NASDAQ:MNKD)

Q2 2012 Earnings Call

August 7, 2012 9:00 am ET

Executives

Matthew J. Pfeffer – Chief Financial Officer and Corporate Vice President

Hakan S. Edstrom – President, Chief Operating Officer and Director

Alfred E. Mann – Chairman and Chief Executive Officer

Analysts

Seamus Fernandez – Leerink Swann LLC

Matthew J. Lowe – JPMorgan Securities LLC

Keith A. Markey – Griffin Securities, Inc.

Tazeen Ahmad – Merrill Lynch, Pierce, Fenner & Smith, Inc.

Tom J. Russo – Robert W. Baird & Co.

Operator

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the MannKind Corporation’s Second Quarter 2012 Conference Call. My name is John and I'll be your operator for today’s 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 August 7, 2012.

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

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

Matthew J. Pfeffer

Good morning and thank you for participating in today’s call. I will summarize our financial results for the second quarter of 2012 as reported earlier today, Hakan will then discuss our current operations and Al will conclude with an overview, before we 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’s 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’s accurate only as of the date of this live broadcast, August 7, 2012. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

For the second quarter of 2012, total operating expenses were $44.1 million compared to $33.9 million in the first quarter of 2012, and $39.2 million in the second quarter of 2011. R&D expenses were $26.6 million for the second quarter of 2012 compared to $24.2 million for the first quarter of 2012 and $30.3 million for the second quarter of 2011.

The decrease in R&D expenses for the second quarter of 2012 compared to the same quarter in 2011 was primarily due to the settlement of the terminated insulin supply agreement in the second quarter of 2011, partially offset by an increased clinical trial related activities in 2012, which also resulted in increased R&D expenses this quarter compared to last quarter.

General and administrative expenses were $17.1 million for the second quarter of 2012 compared to $9.8 million for the first quarter of 2012 and $8.9 million for the second quarter of the previous year. General and administrative expenses increased this quarter primarily due to $7.7 million litigation settlement accrual related to securities and derivative actions, which I will describe shortly.

The net loss applicable to common stockholders for the second quarter of 2012 was $36.6 million or $0.23 per share based on a weighted average of 159.9 million shares outstanding, compared to a net loss applicable to common stockholders of $44.5 million or $0.37 per share on 121.7 million in weighted average shares outstanding for the second quarter of 2011.

Our cash, cash equivalents and marketable securities at the end of the second quarter of 2012 totaled $32 million. Natural resources including the remaining credit facility from Al amounted to $58.9 million as of June 30, 2012.

Our cash burn decreased from $33.3 million spent in Q1 2012 to $24.7 million in the second quarter of 2012. We expect though that our spending will accelerate through the end of 2012 as we complete the trials and approach commercialization.

With our cash on hand and the amount available under the credit facility from Al, we believe we'll be able to fund our operations comfortably into the fourth quarter of 2012. We continue to pursue additional funding opportunities to extend our cash runway, but I cannot comment further until we have something definitive to announce.

It’s also worth noting that the company recently settled the securities class action and derivative litigation pending against it in Federal and State Court. Specifically, on July 26, 2012, we announced that the company and other named defendants had entered into a stipulation of settlement to resolve the Federal Securities class action in the Central District of California. Pursuant to that stipulation in an exchange for release of all claims and dismissal of the action with prejudice, the company's insurers agreed to pay $16 million and MannKind agreed to issue approximately 2.8 million shares to the class members.

On August 6, 2012, we announced that the company had entered into a stipulation of settlement to also resolve the derivative lawsuits pending in Federal Court in the Central District of California and in State Court, Los Angeles.

Pursuant to the stipulation in an exchange for release of all claims and dismissal of the derivative actions with prejudice, the company agreed to adopt certain corporate governance measures as insurers agreed to pay $800,000 to plaintiffs’ attorney and MannKind agreed to issue 225,000 shares to plaintiffs’ attorneys. Both settlements are subject to court approval in notice to MannKind stockholders.

By entering into these stipulations of settlement, defendants in the company did not and do not in any admit fault or reliability and continue to deny any and all allegations of wrongdoing arising out of the litigation. A copy of the stipulation of settlement in these matter is attached to the company’s previously filed forms 8-K announcing the settlement.

Another item to note this quarter is $10.3 million included in other income related to the change in fair value of a forward purchase contract, which met the definition of a derivative instrument. As we disclosed last quarter, we did not have sufficient available shares to complete the Mann Group common stock purchase agreement pending approval by our stockholders.

Once our stockholders approve the increase the authorized number of shares on May 17, we will require to account for the change in fair value of the derivative instrument and we’re no longer required to reflect changes in the fair value of this derivative instrument in our operating statement.

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

Hakan S. Edstrom

Thank you, Matt. Good morning. We continue to progress the combat of the clinical trials required for resubmission. We have now screened more than 87% of the patients required for Study 171 and we have screened 83% for study 175.

As we explained at the last earnings call, we have seen a higher-than-expected screen failure rate in these trials. So we’ve had to screen significantly more patient in both trials. Nonetheless, we expect screening in both studies to be completed next month.

In addition to presume the two affinitive trials, we recently locked the database for Study 176, a study that examine the dose proportionality of AFREZZA up to a maximum dose of 80 units. We also completed dosing in Study 177 in which we compare the pharmacokinetics over AFREZZA and the rapid acting insulin analog.

Furthermore, we are in the final planning phases for human factors validation study for the Dreamboat inhaler. This study will demonstrate the ability of patients to utilize AFREZZA appropriately and we expect this study to complete well in advance of the resubmission.

We recognize that the timeline for the resubmission has been under pressure and are focusing resources on completion of all preparatory work, such as statistical programming, expanding the prepared shelf for a submission document as much as possible and establishing a dedicated team for each key document.

During the development of AFREZZA and our second generation inhaler Dreamboat, we have been gaining considerable experience with powder formulation and delivery systems. Representations at scientific meetings and in other industry events, we’re now on the rage of a number of countries and have begun to explore the feasibility of delivering a number of APIs using our technology.

While these activities are in early stages we are pleased with the interest we have seen in the pharmaceutical biotech industry and see it as of the recognition of the value of our technology.

Concluding my section, we are proud to announce the issuance of a new patent with claims covering optimal Technosphere Microparticles as well as methods of making such compositions and methods of treating endocrine-related diseases including diabetes using these microparticles. These patent extends our matter-based patent protection for AFREZZA until 2031, a significant added value to the AFREZZA IP state.

And with that, let me hand the meeting over to Al. Al please go ahead.

Alfred E. Mann

Thank you, Hakan, and good morning, ladies and gentlemen. As you've heard from Hakan, we’re making excellent progress enrolling patients in the clinical MKC-171 trial and also in the 175 trial. As we’ve disclosed a couple of months ago, for these trials we’re needed to screen far more patients than we had earlier planned.

Our original estimate for 171 had been to screen 942 patients to end up with 471 randomized patients and 399 finishing. But even though the trials require only non-inferiority for approval, the FDA wants us to include patients with high starting HbA1c, so that the average will be close to 8.5%. That should enable us to show substantial lowering of A1cs even for those poorly controlled patients.

To achieve such an average, it is necessary to have a fair number of patients at the upper end of the range. That is between 9% and 10%. The problem was that at premiere clinics where we are conducting the trials, there are very few patients that are so poorly controlled. Thus for the 171 trial instead of screening about 942 patients have been planned, we are screening almost 1,300 type 1 diabetics. As we had early reported, this increase led to a delay and we are pleased to say that we are now on track as we had last reported. We expect this process to be completed next month.

The last patient first visit for the 175 trial is also on track with the revised schedule, thus both trials are expected to be completed in the second quarter of next year with resubmission of the NDA in Q3.

As Matt noted, the remainder of my $350 million credit lines with the Company will not carry us through the end of this year. We are therefore considering several financing arrangements to provide the needed additional funding going forward.

Partnership and financing discussions are moving along with some very interesting development, but while you no doubt want clarification nothing is firm yet, so there is nothing that can be discussed at this time. With resubmission of the AFREZZA NDA insight, we are moving forward with plans for commercializing this product.

Surely, you are aware that I believe AFREZZA will become a major weapon in the battle against the diabetes pandemic. AFREZZA is very significant because it addresses the glycemic problem in the most natural way, providing the very same needed regular human insulin with the PK/PD profile that mimics natural physiology.

Moreover, by mimicking natural physiologic gluconeogenesis, the relative insulin affect and this is not much less than from injected rapid acting analog. That is new information that is very important, and our delivery is so very simple, so very convenient and so very cost effective.

I find it strange there are still some people describing AFREZZA as just another inhaled insulin. All the other programs for inhalation of insulin were simply directed to eliminating prandial injections. Their clinical benefits were not even as good as those of current prandial insulin product, but AFREZZA is not just a means of eliminating prandial injections, it offers so much more. Those people describing AFREZZA as just another inhaled insulin are missing the point.

AFREZZA will be the first ultra-fast acting prandial insulin. It is a kinetic dynamic profile of AFREZZA that is so unique and so important. It is a powder and thus we've elected to deliver it by inhalation and we do it with our Dreamboat inhaler, which is so very small, so very convenient, so very discrete and so very easy for the patients. But the delivery mode is truly not the most significant feature. Our patients do love the inhalation delivery that eliminates prandial injection.

What will be most significant about AFREZZA, as a commercial product is that it’s not just a prandial insulin for basal/bolus therapy and Type 1 and late Type 2 patients. I am convinced that it will become an effective tool throughout the entire diabetes spectrum. This separate diabetes segments are not precisely quantified, but in the U.S. Type 1 patients comprise only about 5% to 6% of the total number of diabetics, gestational patients another couple of percent and the Type 2 market about 92% or so of the total.

In the dominant Type 2 market only about 30% today use any insulin at all, and those usually start with a basal insulin. Soon after most of those late Type 2 do progress and need to use prandial insulin as well. Thus there in indeed a huge number of diabetes patients using prandial insulin's today.

However, the major opportunity would be even much greater if we were treating the 70% of Type 2 that today do not use any insulin at all. Most of that large pre-insulin Type 2 population today uses oral pills or injected GLP-1 analog. All those alternative Type 2 drugs are directed to accelerating or increasing the remaining pancreatic insulin release, reducing insulin resistance, modifying glycemic metabolism or other means of enhancing the patient's remaining pancreatic insulin function, but almost all the alternative anti-glycemic drugs have side effects, generally have limited effectiveness, and are ever safety concerns for some.

Frankly, the commercial viability of those drugs is largely because today there is no truly faith and convenient prandial insulin. Moreover, with these alternative anti-glycemics most patients are still unable to achieve adequate control.

Indeed, the American Diabetes Association recently changed its recommendation for Type 2 diabetes, proposing an insulin be started in early stage disease as second line therapy just after metformin.

The FDA approves to be in agreement with the ADA in guiding MannKind regarding the MKC175 trial. That study is evaluating AFREZZA in pre-insulin using Type 2 disease. This trial is designed to demonstrate superiority with the addition of AFREZZA. I expect that in these patients, we will see significant reductions HbA1c and I'm thus confident of success in this trial.

Yet as with the MKC171, the agency guidance has directed us to include patients who is starting A1Cs up to 10%. The objective is again for the average to be close to 8.5%. That ought to enable us to demonstrate substantial drops in HbA1c with AFREZZA and that would be very valuable.

However, for a patient to have an A1C of 10%, the fasting blood glucose level would likely be substantially over 200 milligrams per deciliter. Those patients will not be what I would call early stage Type 2s. They should have long ago started basal/bolus insulin therapy.

For patients in this study with fasting levels are nearby 140 milligrams or 150 milligrams per deciliter, which will be more appropriately described as, relatively early stage Type 2s. I am confident of very impressive benefits with AFREZZA. I expect that for these earlier stage Type 2 patients, this trial will show that most compliant patients will reach A1Cs below the ADA target of 7%, mainly below the endocrinologist target of 6.5% and quite a few even under 6% and with very little risk of severe hypos.

To show this we will separately review the results of this trial for those early stage patients.

Remember that in MKC119, we show that type 2 patients could achieve control within the ADA guidelines, no matter what level of carbohydrates is ingested up to over 100 grams and even for a no food at all. A simple relation for each meal in early Type 2s should enable most patients to reach those impressive A1C goals. To be sure, we much await the results of the current trials to make any claims, but I am confident the results will be significant.

Of course, registration trials are complex and there are always risks, but in the real world of diabetes therapy, I have no doubt that the AFREZZA to be far more effective than just a better prandial insulin in basal/bolus therapy.

As said, I predict it will become a major therapy, not only for today's insulin using diabetics, but also for the enormous population of earlier stage diabetic that today do not use any insulin at all. Such a change in direction is consistent with what the ADA and key opinion leaders are recommending. They are saying that insulin should be the second line therapy after metformin that is also consistent with what the FDA has guided to show in MKC175.

Key opinion leaders are even suggesting that by reducing pancreatic stress, AFREZZA may slow and perhaps even soft progression of this disease. Wouldn't that be great? Indeed, I believe so and that is why I have already personally provided about $900 million of the funding for MannKind and AFREZZA.

Thank you. Now, we’ll take your questions.

Question-and-Answer Session

Operator

Thank you. And I’ll begin the question-and-answer session. (Operator Instructions) And our first question from Seamus Fernandez, please go ahead.

Seamus Fernandez – Leerink Swann LLC

Good morning guys, thank you for taking the questions. Just to clarify on a thing what Hakan said, in 2Q are we expecting to see the data or did you say that's the time when you expect to complete enrollment?

Hakan S. Edstrom

We expect to complete enrollment next month.

Seamus Fernandez – Leerink Swann LLC

Okay, so in 2Q you expect to have the top line data?

Hakan S. Edstrom

2013?

Seamus Fernandez – Leerink Swann LLC

Yes.

Hakan S. Edstrom

Yes.

Seamus Fernandez – Leerink Swann LLC

Okay. Then Hakan you also spoke about the – you walk us through the numbers, you had the screen randomizing and what you think will finish the trial. Can you update us – actually first of all, do you think now you have a pretty decent handle on the ratio of patients screened versus the ones who will be treated? And can you tell us – can you disclose how many people have been treated so far in each trial?

Alfred E. Mann

15 patients have already completed the trial.

Seamus Fernandez – Leerink Swann LLC

You said 15% or 15 patients?

Alfred E. Mann

15 patients have completed the trial. But we're on course as Hakan said, we have 86% of the 171 trial already completed and ready and they're not all fully enrolled yet, but they will be shortly and the balance will be done in the next few weeks.

Seamus Fernandez – Leerink Swann LLC

And Al, the 15 number you said it's for 171, correct?

Alfred E. Mann

Yes, that's right. The 175 started later and it’s a faster trail, it won't take it long.

Seamus Fernandez – Leerink Swann LLC

And then the just to clarify again the average starting HbA1c, it was 8.5 for 175, was it the same for 171, was it the same for 175?

Alfred E. Mann

Yes, that's right. It's close to 175, which is I pointed out in my remarks, highly defines early stage type 2, but we will separately evaluate those in the lower part of the A1c range, so that we can show, what I believe will be as enormous opportunity to be able to control people in early stage without all of the issues with alternative therapies, and frankly, in a way which will produce excellent control with virtually no risk of hypos, but of course, we have to wait till we do that before we can make any claims.

Seamus Fernandez – Leerink Swann LLC

A final question and then I'll jump back in the queue, your current thinking about European submission, are you going to wait for potentially a partner to do this or are you in discussions with EMA right now?

Hakan S. Edstrom

We are not in discussions with EMA as we speak, however, as we are preparing the documents for the U.S. submission, we certainly are keeping EMEA submission in mind whether if we sign on the partner early enough certainly we would utilize their resources for application for the European submission as well.

Seamus Fernandez – Leerink Swann LLC

Okay, great. Thank you for taking the questions.

Operator

And our next question is from Cory Kasimov. Please go ahead.

Matthew J. Lowe – JPMorgan Securities LLC

Hi, it's actually Matt Lowe in for Cory today. Just a quick question as most of my questions were answered, but in terms of when you think you might be able to re-file the NDA, was that 3Q, 2013, did I catch that correctly?

Hakan S. Edstrom

Yes. That's correct.

Matthew J. Lowe – JPMorgan Securities LLC

Okay, that’s right. Thank you.

Operator

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

Keith A. Markey – Griffin Securities, Inc.

All right, thank you taking my question. I was wondering if you could give us an update on what your cash burn rate will be for this year, since it's taking a little longer than you had expected to enroll, and also can you give us an estimate for next year?

Matthew J. Pfeffer

Sure, Keith, I'll try to do that. You probably remember in my last call, I think I said we would probably likely be in the 10 to 12 months range, that's the guidance I have been giving pretty much for the whole of this year, obviously we came in at a fair amount below that this quarter, delays and partly because some of these invoicing is a little hard to predict. But I think that's still reasonable guidance, it's just shifting out a little bit further. So I think the burn is likely to peak right around this next third quarter is the likely event. Our trial is fully enrolled, but not as many people have rolled up the back end, and then it's going to trickle back down. I would think that by the time the trial is done early next year or coming to a close early next year, you'll see the burn rates backed down in the more or like the range we’re in for this quarter or if you go back to the fourth quarter of last year before the trial is really got series underway. We are doing about seven a month. This month we did about eight a month and it's going to be somewhere in that neighborhood once the trials wind down. The confounding things will be the speed which we gear up for commercialization that may offset those decreases, but I think that's still a comfortable range.

Keith A. Markey – Griffin Securities, Inc.

Okay, thanks. And kind of a housekeeping question. Can you tell us what the accounts payable were at the end of the quarter?

Matthew J. Pfeffer

I don't have a breakdown in front of me. They were quite high because we had, you remember, this is sort of an accounting anomaly. In the litigation settlement, we showed both the crud payments and a receivable from the insurers because that’s how you have to record it, even though we don't expect to payout any cash related to that litigation settlement. That's all covered by D&O insurance, which is why we have that kind of insurance. Sitting in our tables at the end of the quarter, I think that's a little misleading though because there is an offsetting receivable.

Keith A. Markey – Griffin Securities, Inc.

Yeah, okay great and if I could ask one other question, I was just wondering, has the data since you have some patients that have begun to be treated in the type 1 trial, has the data monitoring committee shown any concerns about hypoglycemia?

Alfred E. Mann

Bob?

Hakan S. Edstrom

We have Bob Baughman here that is responsible for our clinical trials. So, Bob, we've heard any concern regarding hypoglycemia and type 1 trials?

Robert Baughman

No, Hakan, we haven't. There have been no signals at all.

Keith A. Markey – Griffin Securities, Inc.

Okay, great. Thank you.

Operator

Next question is from Tazeen Ahmad. Please go ahead.

Tazeen Ahmad – Merrill Lynch, Pierce, Fenner & Smith, Inc.

Hi, guys thanks for taking my question, just a couple of top level view questions, how long of review period do you expect AFREZZA to have once you respond to the CRL in 3Q of next year. Second question is in terms of the type of partner that you think would be ideal for AFREZZA, are you still thinking that you would like to have a partner who already has a footprint in the diabetes market or are you looking more towards any type of company that has a primary care sales force? Thanks.

Alfred E. Mann

Well, number one is that we still expect a review period of six month with the FDA and that's pretty much set in stone. In regards to partner, I would say they do not necessarily have to be in diabetes. They probably should have some type of endocrine metabolic disease knowledge and presence in terms of their sale forces and yes, we believe that access to the general care physician is an important component, but other than that, we are pretty open-minded in looking at what type of partners we will consider.

Tazeen Ahmad – Merrill Lynch, Pierce, Fenner & Smith, Inc.

Is it your primary focus to secure a partner for the U.S. territories before any other regions or are you looking at all worldwide territories at the same time?

Alfred E. Mann

Well, what we've said is that we are looking for a global partner, so that certainly been part I'll say the search criteria. However, there are a number of strong regional partners that have they come to our knowledge and approached us, so we haven't certainly not excluded that as an option, but obviously based on the regulatory approval. The U.S. will be the more significant market early on.

Tazeen Ahmad – Merrill Lynch, Pierce, Fenner & Smith, Inc.

Okay, thanks.

Operator

(Operator Instructions) And we do have a question from Tom Russo. Please go ahead.

Tom J. Russo – Robert W. Baird & Co.

Good morning and thanks for taking the question. I just had a multi-part question on the type 2 trial. Can you remind us, have you mentioned before the FDA's request for an average 8.5 starting A1C and if not, why are you highlighting that now? And then in the past you've been very bullish on this design versus placebo, because it could help marketing for earlier stage patients, but now kind of highlighting cuts of the data rather than I guess the full data from the trial. So, I was just hoping you could put this on the context and maybe just remind us again who suggested this trial and maybe what you expect the indication and labeling to have further type 2 population?

Hakan S. Edstrom

First, let me say that this was guidance from the FDA itself. They suggested this will be a very valuable trial for us. As far as where we started with the A1C average that I'm not sure, I think we disclosed that earlier, but we never really highlighted it, but as we start to review the details, it seems that the high 1Cs are not really early stage diabetic and what’s happened recently the American Diabetes Association is now recommending insulin use as in early stage type 2. So, if, with that in mind, as we look at the 175 protocol it's clear that the people in the upper end of the range of that trial are really not early stage type 2. They may be non-insulin using, but when you got a fasting glucose level of 200 to 250, you're no longer an early stage type 2. So, the intention that we have now is to look at the early stage type 2s separately out of that trial and because there I think we will show amazing benefits for those patients. So, that's why we want to look at that group separately.

Tom J. Russo – Robert W. Baird & Co.

Okay and just to clarify that the design of this trial this was FDA's preferred design as opposed to an alternative?

Hakan S. Edstrom

Absolutely they suggested the trial.

Alfred E. Mann

That is correct.

Tom J. Russo – Robert W. Baird & Co.

Okay, thank you.

Hakan S. Edstrom

They actually even said that they would approve AFREZZA without a type 2 trial, but they recommended this as being a very significant need and asset to do this trial.

Tom J. Russo – Robert W. Baird & Co.

Okay, thank you.

Operator

And that was our last question. I'll turn it back over to you Mr. Mann, if you have any closing remarks.

Alfred E. Mann

Well, it's been an interesting quarter, lots going on although not a lot we can talk about except for the trials, and we are making good progress and we are looking forward to seeing you all again, and speaking with you at the next quarterly conference call, and probably at some interim information that will be released in the interim. Thank you again for joining us today.

Operator

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

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