MannKind Corp (MNKD) 2010 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation's third 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, October 29, 2010.

Joining us today from MannKind are Chairman and CEO Alfred Mann, President and C00 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.

Good morning, and thank you for participating in today's call.

I'll summarize our financial results for the third 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 (technical difficulty) the Securities and Exchange Act of 1934.

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, October 29, 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's start with the financials.

For the third quarter of 2010, total operating expenses were $42.5 million, compared to $42.8 million for the third quarter of 2009 and $37.4 million for the (technical difficulty) 2010.

Research and development expenses were $31.4 million for the third quarter of 2010 (technical difficulty) [compared to] $30.5 million for the third quarter of 2009 and $26.2 million for the second quarter of 2010.

The increase in R&D expenses for the third quarter of 2010 compared to the same quarter in 2009 was primarily due to raw material purchases in the third quarter of 2010, offset by decreased costs associated with the clinical development of AFREZZA and after the submission of its NDA in March 2009.

General and administrative expenses were $11.1 million for the third quarter of 2010, compared to $12.3 million for the third quarter of 2009 and $11.2 million for the second quarter of 2010.

The net loss applicable to common stockholders for the third quarter of 2010 was $45.3 million or $0.40 per share, compared with a net loss applicable to common stockholders of $45.6 million or $0.42 per share for the third quarter of 2009.

Our cash, cash equivalents and marketable securities at the end of the quarter totaled $98 million.

Our available financial resources, including both cash on hand and the remaining credit facility from Al, amounted to $196 million as of September 30, 2010.

Our cash burn for the quarter was essentially flat with $38.5 million spent in Q3, compared to $37.8 million in Q2.

With our cash in hand and the amount still available under the credit facility from Al, and not including any potential proceeds from future sales of equity (technical difficulty) [to] Seaside 88, we believe we will be able to fund our operations into the third quarter 2011. (technical difficulty)

We continue to assess our operational plan for the balance of 2010 in order to find ways of extending our cash runway further.

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

Thank you Matt. Good morning.

During this third quarter we have focused our (inaudible) on the progression of the NDA, interactions with potential partners (technical difficulty), preparation for commercialization, and the de-initiation of the oncology 1106 Phase 2 trial.

Regarding the NDA resubmission, we understand that the FDA is currently reviewing our submission, and as of this moment we have not received any feedback that would indicate a concern with our resubmission or the PDUFA date.

We will certainly continue to work in the FDA in a collaborative manner going forward.

Also, we get asked from time to time about the minutes from the end of the review meeting we had last June. Our understanding is that the FDA is focused on our resubmission of the NDA, so the minutes may have taken a lower priority.

With the recent CRLs to Amylin, Alexa and Arena, there seems to be concern in the industry that FDA actions are becoming less predictable.

But the CRL to Amylin regarding Bydureon was specific to a requirement of the FDA guidelines for a QT study. Apparently, Amylin did not perform the specified test, and that led to the CRL.

We do not anticipate any such issue for AFREZZA, because we did conduct the QT study following in depth discussion with the FDA on the study protocol.

Nevertheless, the unease in the industry can certainly affect [Ardea's] transaction. We believe that is prudent for us to be patient in our partnership discussion because these negotiations will probably be more productive and deal terms more favorable once AFREZZA is approved, or at least when the label is finalized.

We our therefore continuing our interactions with potential strategic marketing partners with the aim of aligning these negotiations with a PDUFA date.

And as you can appreciate, we are rapidly approaching our PDUFA date, so it would in any case be difficult to finalize a transaction before PDUFA.

We recently received a first of several packaging machines at our manufacturing facility in Danbury. It's exciting to see the Technosphere AFREZZA technology becoming a commercial (technical difficulty) byproduct opportunity and to see Danbury facility progressing towards full-scale manufacturing.

The older [scaler] (inaudible) has been very successful, and the (inaudible) activities continue.

In our continued efforts to further differentiate AFREZZA from other diabetes therapies, we have planned a few new trials. But I will hand the call over to Dr. Peter Richardson to address some of these initiatives and the start of our Phase 2 oncology trial. Peter?

Thank you Hakan and good morning.

In today's call I would like to update you on the progress in three areas over the past quarter, the ongoing FDA review of our class 2 resubmission for AFREZZA, the next steps to our [3B4] program, and the start of our Phase 2 program with MKC1106.

Our interactions with the agency have been routine to this point, and the indications are that the review is progressing normally. We're still a couple of months away from the PDUFA date, and at this point stage we do not anticipate significant discussion of the potential label.

As has been the consistent feedback from the reviewing division, we have not had any indication that there would be any plans for an advisory committee for AFREZZA. The focus seems to be getting on with the review of the data set that we have presented to address the points to the complete response letter, as indicated by the acceptance of our resubmission for review early in July.

We do not anticipate giving further updates or commentary on the progress of the review or commenting on the FDA interaction until we've received either a definitive action from FDA or a change in the timing of their response.

In the meanwhile, we've started preparation of our planned Phase 3B [fall] program and aim to support the launch of AFREZZA with additional new data from studies conducted within the anticipated label. These studies are intended to further demonstrate the significant benefits of AFREZZA.

We intend to prepare these studies and conduct them in two phases. The first phase will be a small pilot study followed by a large expansion later.

The first trial to start will be [Affinity 2], a study comparing mealtime AFREZZA head-to-head with mealtime Humalog in patients with type II diabetes requiring insulin intensification. We know this is an area of great interest to patients and physicians, who wish to apply a more physiological insulin regimen in their patients but are limited at present by the complexity and poor acceptance of regimens using the injected insulin analogues.

This trial incorporates intensive treat to target requirements that should result in getting more patients to their therapeutic goal of an HbA1c of less than 7% without dose limiting hypoglycemia.

The results in type II patients that we've presented comparing AFREZZA against pre-mixed analogues, as reported in The Lancet earlier this year, along with results in type I patients from trial MKC117 comparing AFREZZA to insulin (inaudible) allow us to design a study that should show some of the real benefits of AFREZZA in aggressive diabetes management.

Sites and patients are presently being initiated for the pilot phase of this study in anticipation of our pending action date.

Two type I studies, [Affinity 1 and as Affinity P] will be started with more aggressive treat to target algorithms in patients using basal injections and in patients using insulin pumps, respectively.

Based on our analyses of study 117, we believe there is a major opportunity for further improving on the numbers of patients able to reach near normal HbA1c levels. We expect in this new study that significantly fewer patients will experience hypoglycemia with AFREZZA than with insulin analogues, even when trying to achieve the goal of nearly normal HbA1c of 6.5% or even less.

These two type I studies will pilot using unique kinetics of AFREZZA to allow dose optimization based upon measured glucose values rather than carbohydrate counting. Such a therapy would be a paradigm changing approach in the field.

We're working through the final details of the protocol, and again, plan to start these in selected specialist diabetes centers over the next several months.

It's a key part of our strategy to work closely with opinion leaders as we move toward product launch and give hands-on experience using AFREZZA in a variety of situations where our benefits will be the most important.

Meanwhile, as we progress our launch plans, further Phase [4] activities are being planned to establish the use of AFREZZA earlier in the treatment options, but we would anticipate initiating these trials only with our partner.

With our successful financing we've been able to progress our novel cancer immunotherapy program, MKC1106. We've moved forward with our Phase 2 study based on the data from Phase 1, in which both trials met their pre-specified endpoints and demonstrated sustained immune response with excellent tolerability and evidence of sustained clinical response in a subset of patients.

For this Phase 2 study we selected a target approach in advanced melanoma patients with minimal visceral disease, where we've seen the best results to date. Indeed, we observed several patients showing sustained efficacy for over a year, with significant reductions in tumor size as judged by [rhesus] criteria.

We're using an efficient, two-stage design that will allow was to evaluate the outcome after treating up to 19 patients, and then if successful, adding a stage with up to another 25 patients. This study should provide definitive proof of concept for our intranodal approach in immunotherapy in a disease with significant unmet need.

This plan will also allow was to optimize our partnering strategy based on the size and scope of the regulatory requirements, which will depend on the robustness of the clinical response seen in this next study.

Our first patient was dosed in mid-October, and we anticipate recruitment completing the first part of the study during the first half of 2011.

And with that, let me turn the call over to Al Mann.

Thank you Peter. As Hakan and Peter have said, the FDA review of the amended AFREZZA NDA is proceeding towards a December 29 PDUFA. Let me repeat that although we cannot predict actions by the agency, we have received nothing so far that would suggest any issue that my derail or delay approval of AFREZZA beyond the scheduled action date.

We're continuing to work collaboratively with the agency to support their review of our resubmission.

Even before approval and a partnership, it is important that we began planning for commercialization of the AFREZZA system. MannKind must therefore increase that focus and begin to plan for the launch.

Our goal is to secure a global partnership with a major company, and such discussions with a number of potential partners are moving forward. However, as Hakan noted, we do not expect to reach closure until after the label is finalized.

That said, we can't comment further on a partnership until it is appropriate to announce a definitive agreement.

In the meantime, we are preparing for commercial readiness. The first of the new commercial filling and packaging machines that are to be used with the AFREZZA inhalation system was delivered to our Danbury, Connecticut factory in August.

We're in the process of qualifying that equipment, which has been in development for over a year.

This new system is something to behold. It is fully automated and truly and amazing. It's huge, about 85 feet long.

The input is Technosphere insulin powder, dose cups, cartridge covers and the packaging materials. The output is finished boxes of 90 cartridges that should be suitable for one month of therapy for most patients.

The automation includes inspection and weighing of each cartridge, and any cartridges failing inspection are replaced by the robot.

This system produces cartridges at the rate of 400 per minute. 15 completed cartridges are sealed individually in a blister package. Two of these are sealed in a foil bag, and three bags plus two inhalers and the package insert are placed in the box.

Three of the commercial systems at launch will be sufficient to serve about 400,000 patients.

When the Danbury plant is fully equipped, the capacity is expected to be sufficient to serve about 2 million people.

At the price of current rapid acting insulin analogues of equivalent dose, this capacity would potentially generate overall revenues of close to $4 billion.

You may wonder why we're already thinking about production capacity. What do we expect for early market penetration and rate of increasing penetration that would justify this?

We're confident of rapid and substantial penetration because of the many significant and unique benefits of therapy with AFREZZA for most people with diabetes.

So what are the important advantages AFREZZA that generate this confidence?

I believe that we will be able to assert -- one, simple, convenient [discrete] delivery; no need for complex titration for meals; A1C comparable, today's best standard of care; less hypoglycemic risk; lower postprandial highs; lower fasting glucose levels; less weight gain; and little need for meal time glucose measurements.

AFREZZA as well tolerated, and we have not identified any safety signals, though we will not recommended it for patients with compromised lung function.

Thus I say that AFREZZA will fill what today is a poorly met need in a burgeoning market. This advanced therapy could not be more timely.

The US Centers for Disease Control has just released a frightening prediction. By mid century the prevalence just in adults is projected to be between 21% and 33% of the US population.

As we prepare for commercialization, we want now to highlight the unique benefits of AFREZZA.

The FDA has not asked us for any new trials, but additional data could accelerate penetration after launch.

Peter describes several Phase 3B and 4 studies that are intended to enable later label expansion and to enhance the market opportunity. Those trials are being initiated as small pilot studies before a partnership. But our intention is for expansion of these studies to be funded by our partner.

The objectives are to further reinforce the benefits I just outlined and to demonstrate better A1C's and still other advantages with AFREZZA compared to the standard of care in both type I and type II basal/bolus therapy, as well as monotherapy in early-stage type II patients.

An important reason for starting these studies now before approval is to enable us to generate echo cardiac evaluations for a subgroup of patients in order to support a market authorization application with the EMA for Europe.

All of this leads me to comment on the market opportunity for AFREZZA. Based on my long experience in this field, I believe that AFREZZA has the potential to change diabetes therapy. In patients with type I diabetes AFREZZA insulin for prandial control in conjunction with an optimized, long-acting insulin may prove to be the best therapy until we can find a cure for this devastating disease.

The basal insulin can include one of the new, longer-acting insulins in development or even a basal pump. We're actually working actively with a juvenile diabetes research foundation who have funded a study to further explore the AFREZZA basal pump combination.

For type II's, based on my understanding of the mechanism of the disease, AFREZZA may play an important role early in management of the disease. After all, the underlying deficit begins with a loss of prandial glucose control. As Peter noted, we intend to study this in clinical trials now being planned.

Early use of prandial insulins in type II has not been pursued in the past, largely because of the deficiencies of current products. Yet many KOLs believe that there will be an important role for earlier use of ultra-fast acting insulins that may even contribute to preventing progression of the disease.

There was a time until recently when a few people questioned even the approvability of the AFREZZA system. Most of those doubters seem now to be shifting their question to the size of the market opportunity for AFREZZA.

This negativity seems to be based on the incredible failure of Exubera. But it is foolish to compare these two widely different products. That comparison makes no sense at all.

Interestingly, this skepticism at this time seems almost entirely to be found in the financial community. We see very little skepticism by patients or by healthcare professionals -- not by specialists, not by primary care physicians, not by nurses and not by diabetes educators.

On the contrary, we see substantially increasing interest in AFREZZA. This has been reflected in various surveys, including those done by Close Concerns at the last three ADA conventions.

In June 2008, even before completion of our Phase 3 trials and just a few weeks after the Exubera meltdown, only 28% of healthcare professionals in the Close Concerns survey said they would use AFREZZA in their practice. A year later when the professionals began to realize the features and benefits of AFREZZA, the number of AGPs that would consider such use had risen to 48%. By June of this year, with people increasingly realizing the significance of AFREZZA, the percentage of positive AGPs had driven risen to 95%.

While the Close Concerns survey is not a rigorous market evaluation, it does indicate that there currently seems to be minimal concern and rapidly growing interest in AFREZZA among diabetes professionals.

More to the point, as we reported earlier, MannKind has contracted for a number of rigorous professional market studies. We earlier described a significant study in the US and the five major markets of Europe conducted in the spring of 2009.

In that study 611 physicians, almost evenly divided between specialists and PCPs, reviewed actual patient files and concluded they would likely consider prescribing AFREZZA insulin for about 25% or more of both their type I and their type II patients. Even higher in France, Spain and Italy, though somewhat lower in Germany.

While the results of that study and others before would have to be heavily discounted creating a credible business model, they do validate that there was significant interest in AFREZZA even last year, and I'd say that interest is growing.

With just a small fraction of those projected indications, it would seem the prediction of a multibillion-dollar opportunity for AFREZZA by us and also by several of our potential partners could prove to be quite conservative.

With that, I thank you for joining us today and would like to open up the call for your questions.

Operator?

(Operator Instructions) Simos Simeonidis.

It's Simos from Rodman & Renshaw.

Hakan, you prefaced some of your remarks when you referenced the Amylin Bydureon situation, and you said basically this doesn't concern us really because they hadn't done the QT study and we have. But I was going to ask you, I think the issue, the bigger issue is not whether you've done the specific study, which you obviously have -- and you have the data -- but would you be concerned that the agency could respond to your response to the first CRL with another CRL that brings up new issues that were not discussed in the first one? -- which is basically what happened to Amylin.

Well, as I said also in my comments, there seems to be a concern of -- that some of the -- the unpredictability of FDA actions right now in the industry. So I certainly cannot feel absolutely confident that that will not happen. The only thing I can say at this point in time, we certainly have no indication in our interactions with FDA that any new issues based on the additional -- requirement for additional information or complementary information have been requested of us.

So certainly I will feel a lot more comfortable after the PDUFA date has passed and nothing has come forward. But at this point in time I have no indication of any further requirement from the FDA.

Okay. And then if you can comment on where the label discussions and their REMS program discussions are right now?

Yes. As I indicated, we're not at a stage of the review of anticipated label discussions. The REMS discussion and the good things they have before the initial CRL are outstanding, and our REMS plan has been submitted, and I anticipate the discussion of that at the end of this cycle.

As Hakan is indicating, what we're dealing with at the moment is the usual technical questions and interest of the agency in the aspects of that, and we're clearly going through a very normal process review, which I think is the way that the agency will be looking at this. It's a very separate, appropriate way of managing it from the agency's point of view.

Final question, you mentioned 60 days left until PDUFA. It's probably likely that you're not going to -- we're not going to see a partnership before then. If you were to get approved at the end of December, would you wait for a partnership to be completed? Or would you try to take advantage of the two or three months until a partnership happens and lunch on your own? What are your thoughts on that?

Well, let me say that we're not planning to launch at the beginning of the year. Our plans -- we've always said we couldn't launch before the second half of next year. We want to have three machines fully installed, validated and ready to go before we actually launch. That's our plan, and so it really is insignificant as to whether we complete the partnership in December or early in the year.

Okay, thank you.

Keith Markey.

This is Keith Markey with Griffin Securities.

I had a couple of questions about the reference to an echocardiogram that would be required or you thought might be useful for the -- for filing with the European Union, and I was wondering if you could tell us a little bit about that and whether that data would be useful for submitting to the FDA at some point.

Yes Keith. The echo data has been something the agent has requested -- the EMEA had requested in one of the discussions that we had with them.

We believe it would be useful to have those data at the time we make the filing in Europe, which we have not done.

I think as we are -- as the timing here has progressed, we're looking at being able to put a substantial data set with the new device into a submission in Europe and so generating some echo data if the subset of patients in these studies is a very appropriate thing to do.

Obviously longer-term echo data from the European point of view can be submitted later in the review cycle.

So that is our plan at the moment, and I think it makes absolute sense to take that opportunity of doing that in these 3B/4 studies.

So we should expect the echo data to be completed after you've actually already partnered?

Yes, in the longer term. I think we're doing this really just to enable us to start that filing process in Europe and have ongoing echo data available.

Okay, great. Thanks. Then one other question -- when might you provide interim data from the open label melanoma study?

Clearly we -- on completion of 19 patients, we will be having a formal look. This is an adaptive, two-stage design. So we will be announcing whether we move forward with the study and add the additional 25 patients, if it looks the appropriate thing to do at that time. So clearly in this patient population we're looking at recruiting fairly slowly and so anticipating we should complete that, first half of next year.

Great, thank you very much.

Steve Byrne.

Bank of America, Merrill.

Peter, can you talk a little bit more that that QTc study? Can you talk about the level of renal impairment that existed in subsets of the patients that you treated in that study? What were the dosing's compared to the AFREZZA dose in the new Dreamboat device?

Yes. Good questions in terms of the QTc study, as it seems that everyone is trying to become an expert on these rapidly. We had the benefits of quite an explicit interaction with the agency around this in terms of obviously as a well-recognized agent is the active ingredient in our product.

Insulin is well-known and characterized, and a QTc would not normally be a requirement there. So we were conducting a QTc study specifically to look at the novel excipients in our product, which is biologically inert FDKP. So you would have no a priori anticipation of any impact on QT changes on something that has absolutely no effect in any preclinical system or any potential to bind with any receptor that is known.

So we had originally approached this from discussion with the agency that a QTc study would not be required, but the agency was very clear in terms of this is now a standard in a New Drug Application, and we interacted over the design of this study. It led us into a (inaudible) review of the protocol.

The protocol has been conducted absolutely according to the guidance, which has been in the industry now for a while, looking at that with a positive control of a drug that does affect the QT interval, and we studied different doses of FDKP. The exposure there would be up to 8 [full A] single cartridge, the lowest dose cartridge, or fourfold, the high-dose cartridge that would be used with patients. And that margin, again, is something that was discussed with the agency in how we should approach that.

The results actually we have summarized on our website, so you can go there, but just to say that there is no indication of a QT issue with the product.

And Peter, does the FDKP accumulate in patients that are renally impaired?

Yeah, well, we've actually well characterized this in terms of mild and moderate. There's no risk of accumulation. The actual risk of the accumulation in renal impairment is to insulin. Insulin is something where you are careful in terms of the handling of insulin patients with severe renal impairment. That's well done.

But in terms of potential for FDKP, no, there's no potential for accumulation in mild/moderate. In severe renal impairment when patients have renal failure, yes, there would be, but that wouldn't be something that you would put into a QT study.

And I thought you -- one of the others that you were planning, Peter, was a repeat of 117 using the Dreamboat device. Is that also in plans?

Yes, well, not a repeat of 117. I think what we're doing is building on the learning from 117. So we've talked about the two studies Affinity 1 and Affinity P.

The one that is most comparable to 117 is Affinity 1, which is an [asyblic] group of patients, but perhaps taking those that are really trying to get closer to a more aggressive target of less than 6.5.

Remembering in 117 what we saw was that we got twice as many patients at those low levels able to get to 6.5 and below without hypoglycemia, and we really want to focus in on that group of patients in Affinity 1, using a modified algorithm as well, allowing patients to adjust dosing and compare to that actual blood glucose measured level.

One of the things that the kinetics allow us to do is be able to react very rapidly to a change, and we're piloting that and looking at how that works in these type I patients, based on our learnings from 117 as to how we can get even further improvement from that.

And just lastly, with the new filling machine, are you guys starting to build inventory?

Not really just yet. First of all, the machines are just going through qualification now, and they have to be validated, so then we'll be of course doing three production lots in the validation program. But we're not yet embarked on an inventory build.

But we will start making powder in the not-too-distant future.

Okay, thank you.

Jon LeCroy.

It's Hapoalim.

I just had a question on Affinity 2 -- how does that differ from I think it would be 014 study, which was in type II diabetics, other than the echo's?

014 was quite a small end of Phase 2, beginning of Phase 3 study. So there we were looking -- if I -- we're looking here in terms of combination with Lantus and that we have got a different algorithm in terms of that. So I think it has got some differences in terms of the 014 study from that which we had.

Okay. And then I think in the past you guys have said how many partners were still in the running. Do you have any comment on what you've narrowed it down to?

No comment at this point until we have something definitive to announce.

Okay. And then have all of the preapproval inspections for the plants in the US, international -- is all that finished at this point with the FDA?

Well, all of that was completed except that of course now that we have the new machine, which they may or may not want to evaluate.

Okay. And then with the track record of the FDA, let's say that the approval process extends beyond the third quarter and the Seaside deal may not be in effect at that point, what are your financing plans beyond the third quarter?

We haven't announced financing plans, and it's probably imprudent to do so that far out. Obviously we anticipate better news than you are anticipating here.

Okay, thanks.

Doug theater.

This is actually Anthony Esposito on behalf of Doug at Imperial Capital.

In terms of the upfront fees you can expect, is there any guidance you can give us or some indication of what kind of historical licensing agreement you're looking at to arrive at your own expectations?

I think it would be unwise to speculate as to what those agreements might look like. We can all go find examples. We don't fully think necessarily they apply. This is a very unique product with a very unique opportunity.

So let's wait and see. When we have something to, announce obviously we will.

Leah Hartman.

It's Leah Hartman with CRT Capital Group.

I did have questions on the QT study, but they've been answered, so thank you very much, Peter, for the detail on the escalated dosing relative to what we expect to be the prescription for patients.

I was wondering if someone could speak to the timing of running the plant validation and when you expect that might get concluded with approval by the FDA? On the plans, please?

Peter, do you want to answer that?

At the moment we've not got an indication that the agency will do a further -- a pre-approval inspection. The one they conducted was very comprehensive, and we're very pleased with that result.

They may come back, but there's no indication of that, and I think that it would really be as we move into the qualification. As Al said, the normal process here is to look at that when you produce commercial batches to ensure that you have met that, and that will be done in discussion with the agent, as would be normal.

Okay, great. So it looks at the moment that there has been nothing arise with respect to the actual manufacturing (multiple speakers)

Absolutely. One of our jobs is to make sure we are ready for the agency. And they of course can come without announcement at anytime, and being prepared for that is something that we ensure we are.

Do you have an update for us with respect to the EMEA filing? I think a long time ago you suggested it would probably be six months post approval in the US, but it sounds like you have a package coming together?

There is certainly a package coming together. The original NDA form is the great basis of that. I think we've taken the opportunity in terms of -- in Europe there are some additional stability requirements of new product with the device and to be able to submit with additional data on that device will be helpful.

Of course, we're really looking to making a submission with a partner, if they're appropriately able to do that.

So the two are somewhat tied, although we could make a submission. We want to do that with the best possible approach we could take.

Then my final question is on the financial side, so Matt, for you. It appears to me you have not yet tapped into that equity line of credit.

No, actually we have.

Okay.

We've done one sale so far.

Because you could start that on September 22, was that the first date?

That was the first potential date. It did not occur on that date.

Remember that we established a $6.50 floor --

Yes.

-- and we weren't above it at that time. It's (technical difficulty) based on the volume weighted average price. We weren't -- so we've only had one sale up to this point. That will be in our Q that I think is getting filed sometime today with (multiple speakers) details.

We don't typically announce each sale as it occurs. It's not required because all of the parameters are out there and public, so people can readily determine whether they occur or not. You do see them in the Q, although I will give you a clue, since Al's conversion of his note is closely linked to that deal and he does have to file that very quickly every time it happens, that will be a good clue there that it has probably occurred.

Okay, all right. And I did catch that hint in the press release that it -- his parallel transaction was being executed. I just didn't have the details of the timing.

So thank you very match.

A pleasure. Thank you.

That does conclude the Q&A portion of today's call.

Thank you very much for joining us, and we look forward to seeing you certainly in the next quarterly call and perhaps sooner. So have a good day.

That does conclude today's presentation. Thank you all for joining. You may disconnect at this time.