Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation fourth quarter 2013 conference call. [Operator instructions.] Joining us today from MannKind are Chairman and CEO Alfred Mann, President and COO Hakan Edstrom and Chief Financial Advisor Matthew Pfeffer. I would now like to turn the call over to Matthew Pfeffer, chief financial officer of MannKind Corporation. Please go ahead.

Good afternoon and thank you for participating in today's call. I will discuss very briefly our financial results for the fourth quarter and full year 2013, as reported this morning. and then turn the call over to Hakan. Before we proceed any 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 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 and is accurate only as of the date of this live broadcast, February 18, 2014. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Turning now to the financials, the net loss applicable to common stockholders for 2013 was $191.5 million, or $0.64 per share, based on 299.6 million weighted average shares outstanding compared with a net loss applicable to common stockholders of $159.4 million, or $0.94 per share, based on 180.9 million weighted average shares outstanding for 2012. The primary factors resulting in this change were an increase in research and development expenses due to an increase in noncash compensation expense, partially offset by decreased clinical trial related costs resulting from the completion of the Affinity studies. Also affecting this outcome was an increase in general and administrative expense, due primarily to increased stock compensation expense and professional, legal, and financing fees in 2013, partially offset by the nonrecurrence of the litigation settlement accrual made in 2012. Financing activities in the fourth quarter of 2013, as previously announced, included the receipt of $45…

Thank you, Matt. Good afternoon. Today my comments are going to be relatively brief. In summary, the regulatory process is proceeding as anticipated. Our interaction has been the usual Q&A with some follow-up questions to our submission. We are also well underway in our preparation for the AdCom committee meeting on April 1, guided by a reputable consulting company with extensive experience on guiding companies through AdCom sessions and with the support of select experts and potential areas of AdCom interest. The PDUFA date of April 15 still stands, and no indication has been received from the FDA that would alter that target date for approval. Our manufacturing operation in Danbury is ready for any and all inspections that the agency may consider, and this includes our staff also working closely with our vendors, providing us with the inhalers, the cartridges, and the FDKP vehicle. Beyond manufacturing inspection readiness for regulatory purposes, we are also actively building commercial manufacturing readiness. Upon approval and partnership agreement, we want to be able to support a commercial launch within six months of those events. Thus, we are in the process of ongoing facility configuration to accommodate two more filling lines, and up to a 375 million unit cartridge capacity early in 2015. Regarding the partnership process, I will only say at this time that we are pleased with the support from Greenhill and Company and with the progress that we have made toward securing a partnership. And with those short comments, I will hand the commentary over to Al for some remarks.

Thank you, Hakan, and good afternoon, ladies and gentlemen. As Hakan noted, the FDA’s review of the AFREZZA NDA seems to be proceeding well. We’ve had a number of questions from the agency and have been able to provide responses to all of them in a timely fashion. So, the FDA review appears to be on course for the April 15 PDUFA date. An advisory committee meeting has been tentatively scheduled for April 1, and our preparations for that important step are well underway. So why is there to be an advisory committee meeting? There’s actually FDA guidance which states that first-in-class medical projects should be referred to an advisory committee, and we are asking the FDA to approve something that we believe will be the very first ultrafast-acting insulin. After all, AFREZZA, which peaks in 12 to 15 minutes and is almost gone in 2.5 to 3 hours, is very different from current prandial insulin, and over time, the use of such ultrarapid action should evolve into a new standard for diabetes therapy. Those rapid kinetics much more closely mimic natural physiologic pancreatic insulin. They do not have the delayed activity and the late persistent hyperinsulinemia of current prandial insulins. AFREZZA does enable substantial lowering of prandial glucose elevations, and also safely lowering fasting glucose levels without having the disadvantages of the risk of hypoglycemia, weight gain, and need for dosing about 15 minutes or so before eating that is present with these current rapid-acting analogs. An ultrarapid insulin without the late hyperinsulinemia after the meal is digested should thus reduce the hypoglycemic risk that today is responsible for requiring fasting glucose to be maintained at abnormally high levels, thereby contributing to serious long-term diabetic complications. The significance of AFREZZA, as a more physiologic prandial insulin, was actually shown…

[Operator instructions] And our first question is going to come from Simos from Cowen & Company. Simos Simeonidis - Cowen & Company : In your discussions with FDA right now, are any of them related to the AdCom? And is there any way to help us narrow down what the focus of the AdCom may be other than saying efficacy and safety of the product?

The discussions with FDA at this point in time is purely focused on the submission. We will really not know where the FDA will be coming from in terms of their questions until the briefing document becomes available. So, we do not know yet what the focus of the AdCom committee will be, and that’s why we have to prepare ourselves for a broad range of questions across both efficacy and safety of the product. Simos Simeonidis - Cowen & Company : Given that in the past we have not expected to have an outcome, and now there is kind of a change in thinking at the FDA, can you help us understand, maybe from your interactions with them, and I know there’s been a change of leadership of that section of the FDA, how that came about? What are they communicating with you in terms of why now they wanted to do an AdCom, where in the past they had not requested one?

First of all, as you noted, there was a change in leadership of the division that’s responsible in the bureau. But the second point is that we’re asking the FDA to approve a new class of product, and there’s an FDA guidance that requires that. Simos Simeonidis - Cowen & Company : But that had been the case in the past, and we’ve heard you and the rest of the management team say that there’s no reason to expect one.

Well, the prior leadership didn’t think she needed one, but I’m not sure there was any focus on the new class of product. Simos Simeonidis - Cowen & Company : And then in terms of your thoughts about timing of European submissions, I guess we’ll wait for potential approval in the U.S. first, before we get there or is this something you may want to do with a partner?

Certainly, if this is appropriate, depending on the partner that we end up with, certainly we would rely on them to do so. However, I would say that we ourselves, in preparation for submission to the European community, if need be, but that certainly would follow after U.S. approval because our resources are really tapped out right now in preparation for the FDA review and subsequent approval. Simos Simeonidis - Cowen & Company : In terms of potential commercial effort that may be needed further in the U.S., can you give us an idea of what types of size of sales forces and marketing help you would need, the type of things that you’re talking with your partners about, and would you want to keep, for example, U.S. copromotion rights or would you want to just outlicence AFREZZA to the partner?

If you look at, say, the size of the sales forces, I would say in general to cover the entire markets, [unintelligible] four through 10 and endocrinologists. You’re probably looking, I would say, in the thousand range in terms of sales reps and regional support people and managed care, so that’s probably a guideline number. In regards to copromotion rights, at this point in time, where we stand, I prefer not to comment on that.

And our next question is going to come from Cory Kasimov of JPMorgan.

First of all, just a follow up on what Simos was asking. Has the FDA specifically told you that they consider AFREZZA a new class, when they said they did not in the past?

They didn’t say they did not in the past, we just never focused on that subject.

And then regarding your prior regulatory interactions with the FDA under prior NDAs, how much label discussion took place then? So if you were to have a clean panel on April 1, how much additional label negotiation do you think you would have to still work through to get a decision done within two weeks?

I hate to speculate. I know that we initially had planned that, really during the course of a week, you can accomplish that. So that is still our working assumption. But again, that’s a guesstimate from our side.

And then lastly, just wondering how much partnership discussions, broadly speaking, have changed, if at all, since the announcement of a panel meeting.

Again, I think as in my answer to Simos, I would not comment on that at this point in time.

And our next question is going to come from Steve Byrne of Bank of America.

Hakan, you mentioned a little bit about an expansion in the manufacturing process. Can you just reiterate that? I didn’t quite catch it all. You have three lines fully operational by April, and then what are your expansion plans beyond that?

No, what we do have right now, we have one commercial line in operation. We are in the process of reconfiguring some space and installation of the second and third lines. In early 2015, we should have a capacity up to 375 million cartridges.

With respect to the 175 trial, where the glucose monitoring, at least you hypothesized, affect patient behaviors, do you have thoughts on how to redesign such a study, perhaps as a phase IV study? And is that something that you would want to undertake soon, or wait until you had a partner on board?

I would say at this time, certainly it would be, if anything, a phase IV study. And right now, we are certainly at capacity in terms of utilizing our clinical and regulatory people. So it would most likely be also a discussion with a potential partner to make sure that we accommodate insights and input from a partners. So I would say look at that post-approval.

That is, as you commented, a very significant opportunity to move prandial insulin into early stage type 2, which has never been done because of the limitations of current prandial insulins. And in fact, with the growing skepticism about the safety of even some of the popular alternative antiglycemics, something like AFREZZA, which mimics natural physiologic [unintelligible] insulin, ought to be something to receive some clear attention.

And assuming that prospective partners would have some concerns about the AdCom and the pending label, would you anticipate formalizing the partnering process with deadlines, if you didn’t have a partner by approval?

That’s a hard question.

I mean, could a partnership be in place in terms of tentative agreement and become effective upon approval? That is certainly an option. I didn’t grasp exactly what you were thinking, if this were to be beyond the approval of the product?

That is what I meant. If you don’t have a partner by approval, at that point, would you change the partnering discussions to formalize it in a way that you had specific deadlines to conclude the deal?

Quite honestly, I wouldn’t see a significant difference in our approach from where we are right now. We certainly also have deadlines like performance target dates, so I don’t see a significant change in our process.

And just one last one. What do you anticipate, the majority of patients to use some combination of the three and six unit dose, or just one of those in particular?

My recollection is that most patients will get away with, say, using one dose, then of course you have a combination where you can combine the 10 and the 20. And we will cover up to 80% of patients’ needs with one, two, or a maximum of three cartridges. And that does not seem to be a problem from a patient compliance point of view.

Of course, we want to pursue, as quickly as we can, the nine and 12-unit equivalent cartridges. And we actually have another process that takes us up to very high dose levels, but that’s not ready for submission yet.

And our next question is going to come from Keith Markey with Griffin Securities.

I was just wondering if you could tell us a little bit about the partnering negotiations themselves, just simply, for instance, have you received term sheets, or are you beyond that?

Quite honestly, the only thing I’m able to comment on at this point in time is that we are pleased in terms of our interactions with Greenhill and we are pleased with the progress we’re making together with any partnership discussions. At this point in time, it’s not appropriate for me to make any further statements.

Okay. I’m not sure if I should ask this, but I’ll give it a shot. I just wondered whether pricing has come up in your talks so far, and what your feeling is. In the past, you’ve talked about a small premium to some of the short-acting insulin analog prices for AFREZZA. Is that still reasonable to think of that holding true?

If you remember what we stated was that we do see a price parity with pens, insulin pens, and those are already at about a 20% premium over, say, regular injected insulin. So that is a working assumption that you could count on.

Our next question is going to come from Graig Suvannavejh from MLV & Company. Graig Suvannavejh - MLV & Company: As you think about getting near the advisory panel meeting, is there an expectation we should have that you will host a conference call one way or the other, depending on the outcome of the advisory panel meeting?

We haven’t really actually discussed that. I’d say it’s quite possible. But of course the outcome of the meeting will be immediately known. So it’s not like we’re going to have to announce that information. But depending on how that comes out, it’s quite possible we will. Stay tuned. We’ll let you know. Graig Suvannavejh - MLV & Company : Follow up question, then, would be just I know you’ve done some recent market research work with PCPs and endocrinologists. Is there anything new that you can add in terms of work that you might be doing with payers and potential reimbursement? Or is it still too early in the process for you?

We had meetings with our payers over a year ago, and they were very supportive. But we’ve only talked individually with them since.

I have to say that we worked also extensively with Kantar Health, as a consultant, advisor, to us, where they have represented us and the opportunity, and actually with another outfit as well that unfortunately I don’t remember the name right now. So I would say that we’ve spent considerable time in assessing the pricing, rebates, and the commercial aspects of our product. So I feel that we are well informed and it’s certainly reflected in discussions with potential partners.

And our objective is to try to get into tier 2 as quickly as we can, and that’s why we’ve targeted where we are. Graig Suvannavejh - MLV & Company : I know you mentioned for the first time, at least to me, that you’ve got this Cricket inhaler. So maybe thinking a little further out, maybe it’s premature to do so, but let’s assume that the product gets approved, let’s assume you get a partner. What are the next pipeline priorities for MannKind?

I would say that the next pipeline, other than getting the 9 and 12-unit cartridges approved, would be the revised process that we’ve been working on, which is a much larger range of dose sizes, with single cartridge, and some other very, very significant advantages that we don’t talk about yet.

Let me also say, and make a quick correction to what Al said before, in terms of the Cricket will be used for people who will be in acute pain, not chronic pain. So that would be an opportunity where we would have a disposable device, like the Cricket.

I said it was a disposable device, only for acute pain. It’s not for diabetes.

And Our next question is going to come from Christopher James from Brinson Patrick Securities.

I just have one quick follow up regarding the advisory panel. I guess from your ongoing discussions with FDA, do you anticipate that partners outside of, let’s say, metabolic and endocrine, will be involved? For example, do you anticipate FDA would want individuals from pulmonary devices and pediatrics to bless it?

Yes, while the meeting is run by the one division, we do expect that other divisions certainly will be involved since they’ve been intimately involved in the overall review of the submission.

There are no additional questions at this time, so I’d like to turn the call over to Mr. Mann.