Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation Fourth Quarter 2008 Conference Call. At this time, all participants are in 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, February 17 of 2009. Joining us today from MannKind are Chairman and CEO, Alfred Mann; President and COO, Hakan Edstrom; and Chief Financial Officer, Matthew Pfeffer; and Chief Scientific Officer, Peter Richardson. Now I would like to turn the call over to Mr. Matthew Pfeffer, Chief Financial Officer of MannKind Corporation. Please go ahead.

Good afternoon, and thank you for participating in today’s call. I’ll first summarize our financial results for the fourth quarter of 2008 as reported earlier today. Next Hakan and Peter will provide an update on key accomplishments during the past year, and finally, Al will comment on the current situation and our outlook going forward. We’ll then open up the call to your questions. But before we proceed further, please note that comments made during this call will include forward-looking statements within the meaning of the federal securities laws. It is possible 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, February 17, 2009. 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 2008, total operating expenses were $81.8 million, compared to $79.1 million for the fourth quarter of 2007. R&D expenses were $68.8 million for the fourth quarter of 2008, compared to $66.8 million for the fourth quarter of 2007. The increase in R&D expenses was primarily due to increased manufacturing costs including clinical supplies for AFRESA, offset in part by lower purchase services and the associated clinical development programs and lower technology agreement costs in oncology research programs. General and administrative expenses were $13.0 million for the fourth quarter of 2008, compared to $12.3 million for the fourth quarter of 2007 and $13.4 million for the previous quarter of this year. G&A expenses…

Thank you, Matt and good afternoon. As you can well understand we are excited about the fact that we will submit the AFRESA NDA this month. After tremendous efforts from our people including the late-stage bioequivalent study of the commercial inhaler, compared with the clinical version and the final assembly of the NDA document, we are now in the electronic translation and hyperlinking phase. The complexity and size of the final NDA has taxed our and our vendors' resources to the maximum. However, in spite of this and our relentless quest for a quality submission, we are pleased to be able to submit the NDA this month. And while we are now readying ourselves with the interactions with the FDA, regarding PAI inspections, queries regarding our filing and the potential advisor panel meeting, we’re also devoting significant efforts towards the commercialization of AFRESA. This includes, as you well know, partnership discussions with returning as well as new partner candidates. These discussions will begin in earnest following the NDA submission later this month when we again can devote staff, time, and management focus towards these objectives. Beyond that, we do not have any further comments regarding our partnership activities at this time. We've also made significant progress during this past year constantly improving our product, considering that we already have the advantage from a high bioavailability, certainly as compared to other product candidates in this category. We had a favorable starting point. Now, having worked our key supply chain relationships and been fine-tuning our form fill and finishing processes, we are confident that we can effectively compete with both current state-of-the-art injectable insulin therapies and most oral therapies both in Europe and in the U.S. In fact, we may be in a position to share more of the progress we've made in this respect at our next earnings call. And these efforts do not include the option we have with SemBioSys’ for the plant-derived insulin, which in itself makes good strategic sense, but is a more long-term opportunity. Well with that, let me now hand the call over to Peter, who will give you an update on the status of our NDA and what we believe our label could look like considering our Phase III clinical trial data. Peter?

Thanks Hakan. I’m obviously very pleased to be able to report that the NDA is on track to submission by the end of this February. And as you know, we had a successful pre-NDA meeting held in the FDA on July the 14 of last year when the agency endorsed our position that with data generated since the end of the Phase II meeting, we’d be in a position to submit an application. Remind that the agency requested an additional bioequivalent study comparing with the marketed commercial device and with that used in the clinical program known as clinical device. Following that meeting, the trial of 84 patients was setup, conducted, and analyzed with all data available and reported by the end of January 2009. Allowing for us to maintain the submission date projected for the end month. The agency in addition have specific request for the analysis of data regarding hypoglycemia. The complexity of this analysis has been a rate-limiting factor in our ability to finalize clinical trial reports with summaries. The methodologies required to map the data collected through requested form extremely time consuming and complex. In addition, some of these significant subsets of patients not normally required in an NDA was also requested, and the prediction of these analysis that involves areas of the organization outside of the clinical development fund to logistic supported writing and quality control in excess of 1000 narratives. Indeed, although we did not get a specific letter from the agency, they asked that we conduct a special analysis of cardiovascular events pre-submission. The special pooling strategy was applied using external vendor to maintain impartiality. Following a rigorous methodology, we demonstrated no excess cardiovascular risk with Technosphere insulin compared to the comparative populations we’ve studied. Numbers fall below those triggering the need to…

Thank you, Peter. Peter has given you a brief overview of our NDA and some label expectations for AFRESA. That remarkable file over 450,000 pages is a very comprehensive compilation of the results of a large program that included extensive preclinical studies demonstrating the unique scientific advantages and clean toxicology and carcinogenicity of AFRESA and the data and the valuation over 40 clinical trials in more than 5000 people. Peter, who spent about 20 years at Novartis, describes the NDA as the most sophisticated and most positive he has ever seen. Indeed, the NDA documents, the data that I say to you confirms the extraordinary efficacy and safety of AFRESA. The data shows that AFRESA is superior to other diabetes products and several very important areas without any notable negatives. Some of you have called attention to the fact that in the key target of HbA1c, AFRESA is only comparable to rapid acting analogs, today’s gold standard for prandial glucose control. Frankly, such concerns are misplaced. AFRESA provide the most effective means for prandial glucose control today, and does not cause the frequent post-prandial hypoglycemia effects seen with rapid analog Those large and dangerous plunges below baseline, with injected insulin, lead to an equal or slightly lower average glucose excursion and thus A1C as compared to AFRESA. But AFRESA does not cause those dangerous plunges. It is difference of excursions from baseline that masks the overall superiority of AFRESA. The key to understanding the superiority is that with injectable insulin, both regular insulin and rapid analogs, there are dangerous hypo risk. So, that the fasting glucose is typically managed at dangerously high levels to minimize that serious risk. With high fasting levels and normal A1Cs are almost impossible to reach at least safely. In our trials, we do see some…

Operator?

(Operator Instructions) Our first question comes from Cory Kasimov with JPMorgan. Cory Kasimov – JPMorgan: Hey, good afternoon guys. Thanks for taking the questions. Actually, my clinical questions are basically answered last week at your Breakfast, but some financial ones here. First of all, can you discuss the plans to draw down the remaining loan from Al, would you do this all at once, or is this going to be gradually throughout the year as needed?

It would be gradually throughout the year as needed. You know we get keeps it from having to draw it all at once and frankly what the interest on money we don’t need before we need it. Cory Kasimov – JPMorgan: Okay, so all right. And then in terms of R&D budgeting for 2009, Matt, do you said that you expect the burn to decline by 30% to 40%, but could you give us a little bit more clarity in terms of the contribution from a manufacturing scale up and how that may contribute to R&D spending? And I mean, so you think in the fourth quarters as a decent run rate going forward?

It’s just going to be a little lumpy, but that’s not a bad estimate I think you‘ve seen most of the ramp up in the manufacturing are already built in. We should be able to see reductions pretty much in all areas, but yeah the manufacturing will stay more stable. Cory Kasimov – JPMorgan: Okay and then lastly, as it relates to Hakan’s comment on the cost efficiency of AFRESA, can you guys talk at all about where you expect the gross margins for the product ultimately come out, maybe how you are thinking about pricing at this point and given that you are maybe just about a year away from commercialization? Thanks.

Well we have during actually 2008, met with managed care companies that was responsible really for about 30% of covered labs in the U.S. and what I can tell you at this point in time is knowing what the reimbursement is in terms of tearing and also in terms of the cost did by rapid acting insulins. We feel that we are able to successfully compete in the space where rapid acting insulins are at this point in time from a cost point of view and the reimbursements. Cory Kasimov – JPMorgan: Okay. All right thank you.

(Operator Instructions) Our next question comes from Tom Russo with Baird. Thomas Russo – Robert W. Baird: Good afternoon. Peter, I just wanted to clarify your comment on the cardiovascular profile and I think the analysis that you’ve run suggests that there may not be a post-marketing cardiovascular outcomes trial required. Can you confirm whether that is your actual expectation or not but there would be one or would not be one, post-marketing?

I can confirm that, we have no expectations of that, based on the numbers that we have now run, we don’t show any excess concerns of cardiovascular morbidity or mortality across the program and we’ve had discussions with the agency in terms of where we should go with this they’ve asked us to conduct that but as you know they issued a specific guidance where they gave the levels which may trigger specific a request for the cardiovascular studies post approval. We don’t approach those numbers the natural fact our relative risk is essentially one it’s just over that. So we compare very with controls and we have no expectations that would do that given the profile of that we’ve seen from our studies. Thomas Russo – Robert W. Baird: Okay and then only other question I wanted to clarify was with regard to pulmonary function testing not being required to monitor that do you or do you not anticipate having that test being required upfront before a patient would start a therapy? Thanks.

Well, our position is that we see no basis in which that actually helps in terms of the management of patients that will be taking AFRESA. And our analysis around the pulmonary function have been very reassuring, in terms of there being no generation of a safety signal or there being anything that indicates that there is in pulmonary function testing, either at baseline or subsequently. Of course, this will be this will be a matter of considerable discussion with the Agency. And I’m sure that we will have appropriate discussion around how best to manage patients and insure their safety which is paramount importance. Thomas Russo – Robert W. Baird: Okay, thank you very much.

Our next question comes from Michael Tong with Wachovia Capital Markets. Michael Tong – Wachovia Capital Markets: Hi, thanks for taking my question. Just some thoughts around a partnership, I remember in the past you talked about the preference for a global partner, is that still the case and can you also give some color as to your current thoughts about the regulatory process in the international area in terms of timing and how much behind or not behind the U.S., they are?

We have expressed the desire for global partnership, but we are not sure that we want to define a global partnership as everyplace in the world. Certainly, we would prefer to have a partner that would be responsible for the major markets that exist today. But, we’re flexible on the subject. As far as the regulatory program is concerned, we have planned to work on the filing for the European Union later this year and planning to file it sometime later this year. And we are also talking with the couple of other countries about the regulatory program. And those others are early stages so we are not sure how that’s going to evolve. Michael Tong – Wachovia Capital Markets: And just to clarify on the EU filing plans. Do you believe, you have all the studies in hand right now, that you don’t need additional studies for that filing?

We don’t need additional studies. We will be taking some information from one of our on going studies, which is with Study 117, where we have included the couple of additional end points and which I think will be helpful in the filing. And we would like to include that in the European filing Michael Tong – Wachovia Capital Markets: Great, thank you very much.

(Operator Instructions) Our next question comes from Elizabeth Naldi with Piper Jaffray. Your line is open. Elizabeth Naldi – Piper Jaffray: Hi, thanks for taking my question. I just wondering if you have any pre-launch activities planned for 2009. And if you are going to conduct any further market research in preparation for the launch?

Market research, we have not discussed any specific or recurrence of the reputation of some of these studies we’ve done. We’ve done a number of them and we are not sure that we see any great benefit of doing further ones. We haven’t really discussed that in detail, we might consider doing a study later, when we have more clarity on what the label will actually be.

Yes, that the plan as we said right now is that some of the status that we present for the American market. We are taking those as certainly what Al said, with now a great understanding also what we would expect our future label to be into the European arena, so that that is on our schedule for 2009.

In terms of some of the activities you can expect this year, one of the things that kept us very busy over the holiday period was the production of abstracts for ADA and I was very pleased by these numbers and quality of abstracts that we have been able to submit.

At this time there are no other questions. I would like to turn the call back over to Mr. Al Mann

Well thank you all for joining us today. We are pleased that we seem to have answered your questions, but we look forward to updating you at our next quarterly call.

Thank you, for your participation. You may disconnect at this time.