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Executives

Faith Pomeroy-Ward - Executive Director, IR & Corporate Communications

John Thievon - President and CEO

Dave Becker - EVP and CFO

Analysts

Richard Silver - Barclays Capital

MiddleBrook Pharmaceuticals, Inc. (MBRK) Q2 2009 Earnings Call August 6, 2009 9:00 AM ET

Operator

Good morning. My name is Sarah, and I will be your conference operator today. At this time, I would like to welcome everyone to the MiddleBrook second quarter 2009 results conference call. (Operator instructions).

Faith, you may begin your conference.

Faith Pomeroy-Ward

Thank you, Sarah, and good morning everyone. Before we begin our call, I would like to remind you that this call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Such as, statements about our strategies for the commercial of MOXATAG and improving its market position, the success and financial impact of the $20 max copay program for MOXATAG, the future of the KEFLEX PULSYS products development, our growth strategies, our future financial performance and our potential need for additional capital.

These statements are based on our current expectations and belief, and are subject to a number of risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statement.

Additional information about risks that could cause actual results to differ materially from those in the forward-looking statements made today maybe found under the heading Risk Factors in our annual report on form 10-K for the year ended December 31, 2008, which has been filed with the SEC.

We undertake no obligation to update any of the forward-looking statements made during this call, whether as a result of new information, future developments or otherwise.

This morning, I am joined by President and CEO, John Thievon, and our Executive Vice President and CFO, Dave Becker. We expect today's call to last no more than 30 minutes, including Q&A.

I will turn the call over to John.

John Thievon

Thank you, Faith, and good morning everyone. Welcome to our second quarter call. Our agenda for today's call is as follows. First, I'll provide a business update, then Dave will review our second quarter financial results and provide our business outlook, which will followed by Q&A. After Q&A, I will conclude the call with some brief closing remarks.

As announced in this morning's press release, we achieved our second quarter revenue goal, but more importantly, the first full quarter of our MOXATAG launch to healthcare professionals nationwide. Everyone at MiddleBrook has been focused on the execution of our strategy to commercialize MOXATAG since its March, 16 launch.

While we have produced steady month-over-month prescription gains, we recognized that we've launched into a challenging market, and we have recently taken several steps to accelerate our prescription growth. The most observable of which is our $20 maximum copay program for MOXATAG, which we announced and implemented on July, 15.

We have been monitoring field's feedback regularly to indentify ways to improve our results. We found that physicians readily understood the features and benefits of MOXATAG, and generally they consider MOXATAG an attractive treatment option for strep throat, increasing convenience and compliance relative to conventional therapy. Their primary objection has been cost.

The healthcare industry has been characterized as recession proof for many years, but that seems to have changed with the current economic environment. During this downturn, many retailers have been aggressively marketing and expanding their low priced or free generic antibiotic programs in an effort to draw patients to their stores. Although there is no AB-rated generic equivalent to MOXATAG, we believe that the availability of free and low cost generic amoxicillin has influenced MOXATAG prescription uptake.

Prescribers have long been sensitive to patient copays, and we think the economic environment has heightened their concern, making cost to the patient a stronger factor in prescribing decisions, such that, patient costs competes with clinical benefits.

Our new $20 max copay program for MOXATAG helps address pricing pressure at every decision point in the prescription process. The average copay for MOXATAG is about $45, with copay, it's generally ranging between $20 and $60. Physicians while aware of copay do not typically know individual patient copay amounts. Our $20 max copay program eliminates any guess work on the part of the physician, because commercially insured patients pay only $20 regardless of their copay amount.

To give you a sense of our managed care coverage, MOXATAG is widely available through insurance providers, and we have achieved coverage for approximately 93% of covered commercial lives in the US at Tier III status for both pharmacy benefit managers and managed care organizations.

MOXATAG is currently covered in the third tier with a prior authorization on less than 1% of all commercialized coverage. MOXATAG is also currently covered by Medicaid in more than 45 states. We will continue working to expand our managed care and Medicaid coverage, and we expect our coverage to continue to increase over time.

While the $20 max copay program is the highest profile step taken to accelerate our results, we have other initiatives that will support the work of our field force. In addition to field feedback regarding cost to the patient, we have also gained insight into what healthcare professionals value most about MOXATAG.

Accordingly, our sales methods has evolved as we reply to the prescriber and pharmacist feedback from the field to new and compelling detail pieces that drive home the message points that resonate most with healthcare professionals. We believe these new [sell ways] will help our field generate prescription growth.

For example, as you know, MOXATAG competes in a large market with over 16 million prescriptions filled in 2008 for pharyngitis or strep throat. There is significant use of the macrolide antibiotics, azithromycin or Z-Pak, which is not approved as first-line therapy for our indication, pharyngitis, tonsillitis secondary to strep pyogenes.

In fact, according to IMS Health about five million prescriptions, representing about 30% of the strep throat prescriptions in 2008 were filled with azithromycin. This is likely to due to its convenient dosing and for previous position detailing when azithromycin was available as a branded product. However, macrolide resistant strains of strep pyogenes, the underlying cause of bacterial pharyngitis have been reported, and are increasing.

Healthcare professionals known that judicious use of antibiotics is critical to limit antibiotic resistance, and our sales reps will be using a new [sell way] that emphasizes the importance of a appropriate antibiotic selection in the treatment of strep throat and talking to prescribers about how choosing MOXATAG over macrolide for strep throat is a better choice for therapy, and can help limit resistance.

We're also driving support for MOXATAG at the pharmacy. During the second quarter, we embarked on a major pharmacy initiative to drive awareness of MOXATAG, and compel retailers to stock MOXATAG, including placement on Pharmacy Choice website, the number one site used by pharmacist, pharmacy managers and pharmacy technicians. We've also created a comprehensive pharmacy strep throat guide, which will have broad application now and throughout the strep throat season. Additionally, we are working with chain drug retailers, to help them disseminate MOXATAG for $20 or less, and other MOXATAG marketing communications from their corporate offices. We are also planning a direct mail communication to pharmacists, which will include copay vouchers for use of their customers, just in time for the strep throat season.

MOXATAG distribution improved throughout the second quarter. Another major retailer recently agreed to order ship MOXATAG to its high volume stores, which means that all three top chain drug stores have now initiated order ship programs to their highest volume stores.

Pharmacy detailing of our sales reps confirms that pharmacy stocking has improved to about 70% in our sales territory since launch. We will continue to drive expanded distribution from MOXATAG through trade calls, trade advertising, marketing programs and pharmacy detailing by our 300 sales reps and managers, and most importantly, through MOXATAG prescription generation.

Our trade, marketing and sales teams also increased awareness of MOXATAG through attendance at multiple medical conferences during the second quarter, including the Urgent Care Association of America, the American Academy of Physician Assistance in May and the American Academy of Nurse Practitioners in June. We just participated in the Retail Clinician Education Congress in Florida.

Upcoming physician conferences include the American Academy of Family Physicians in October, and the American Osteopathic Association in November.

To-date, over 21,000 prescriptions has been filled from MOXATAG, and although we only have data covering the first week and half of our new $20 maximum copay program, we're already seeing an increase in prescriptions. Right now, we are still setting the table for the strep season, and we're confident that our field force is making good progress with prescribers.

In fact, we're seeing steady weekly growth in unique MOXATAG prescribers which illustrates that our message is resonating with physicians, and that, they see the value of MOXATAG and the benefits it delivers to patients.

Before I move on to KEFLEX, I want to say that we believe our strategy to commercialize MOXATAG will be successful despite a slower than expected prescription growth rate in the second quarter. Our new $20 maximum copay program addresses cost concerns at the physician, pharmacist and patients levels, and should increase the momentum of prescription growth for MOXATAG.

We'll be making our $20 max copay program card vouchers available for download at MOXATAG.com later this month, which will also help make MOXATAG widely available to commercially insured patients all across the country for no more than $20.

Most importantly, we are executing our multi-tactic promotional strategy, which features face-to-face healthcare professional detailing and sampling by our 300 sales reps and managers in a robust print campaign.

We have expanded distribution significantly, and we successfully increase our managed care coverage over the past few months. Accordingly, we believe we are operating from position of strength as the season for pharyngitis and tonsillitis approaches.

Dave will walk you through our KEFLEX number shortly, but I want to announce our new tele-detailing program for KEFLEX 750. The physicians' targets for MOXATAG and KEFLEX details are not identical due to the products different indications.

Our sale territories are strategically aligned to maximize MOXATAG's market potential. This new KEFLEX tele-detailing program is designed to expand our reach with high prescribers not currently in range for a face-to-face detail.

Tele-detailing agents will detail specialty physicians such as surgeons' dermatologists by phone on KEFLEX 750, and provide the opportunity for these prescribers to receive samples and product information. Outbound calling began last week of July, and we will be monitoring this program over the next few months to assess its effectiveness.

Regarding KEFLEX PULSYS. MiddleBrook previously announced that it had plans to start its Phase III clinical trial for its KEFLEX PULSYS product candidate in 2010, contingent upon the success of MOXATAG launch and FDA's agreement with MiddleBrook's clinical protocol.

You may recall that a couple of years ago, we had gained tentative agreement with FDA regarding our clinical approach to develop a PULSYS-based KEFLEX product. More recently, in November 2008, FDA held an Anti-Infective Drugs Advisory Committee meeting. At that meeting, the panel made recommendations to the FDA that potentially had implications for the development of our KEFLEX product candidate.

Additionally, news guidance regarding the development and approval of anti-bacterial drugs for the treatment of skin infection was anticipated as a result of the advisory committee meeting. Accordingly, in early June, we sought the FDA's re-approval of our non-inferiority approach through the submission of a Special Protocol Assessment for our proposed KEFLEX Phase III study.

As a noted in this morning press release, the FDA responded to MiddleBrook's Special Protocol Assessment on July 30, 2009. This time, MiddleBrook has not gained agreement with FDA regarding the non-inferiority design and planed analysis of the study as outlined in MiddleBrook's Special Protocol Assessment.

Accordingly, MiddleBrook is delaying the development of its KEFLEX PULSYS product candidate. Any future development is contingent upon the successful commercialization of MOXATAG, adequate financial resources, and the FDA's agreement with the revised study design.

Before I turn the call over to Dave, let me provide a brief business development update. The FDA's response to our Special Protocol Assessment has elevated business development as a priority for the company. We have evaluated multiple opportunities since our May, 7 earnings conference call, and we are continuing to aggressively seek opportunities to in-license, co-promote or acquire products to more effectively utilize our sales force, and create value for the company and its stakeholders.

I will now turn the call over to Dave for a review of our financial results and our business outlook.

Dave Becker

Thanks, John, and good morning to everyone. For the second quarter of 2009, our total net revenues were $2.1 million, compared to $2.5 million for the same quarter last year. Net sales of MOXATAG for the second quarter of 2009 totaled $400,000, while net sales for the KEFLEX franchise totaled $1.7 million. In the prior year period, 100% of net sales were related to the KEFLEX franchise.

For the 2009 second quarter, total MOXATAG prescriptions were about 14,500 compared to 900 prescriptions for the quarter ended March 31, 2009. Through the 19 weeks ended, July 24, the latest data point available from IMS Health, cumulative prescriptions for MOXATAG totaled just over 21,000. On a cumulative basis, we are running at a rate of approximately 60% of our prescription forecast that underlies our revenue estimates.

We believe that the number one objection that we have faced has been the out-of-pocket cost to the patient, and to address this, we implemented the $20 max copay program for MOXATAG on July 15.

This program is designed such that patients with insurance would pay $20 or less for the MOXATAG prescriptions. For the week ended July 24, which was the first complete week of the program, we generated 2,048 prescriptions, representing a 30% increase over the prior week.

At this point, with only one full week of data, it is difficult to project a longer term impact of this new program, but we are hopeful that it will effectively support our field forces efforts to increase the number of MOXATAG prescriptions. The maximum copay program will have net revenue and therefore gross margin implications for 2009, and I will address that momentarily.

KEFLEX prescriptions for the second quarter of 2009 were about 42,500 compared to 46,000 for the March quarter, representing a decrease of about 8%. We believe this decline continues to be the result of reduction in promotion that started back in November of 2007, and while we have considerably more sales representatives today, those reps are primarily focused on MOXATAG details to physicians, pharmacy education and stocking initiatives.

Additionally, as John mentioned earlier, our sales territories are strategically aligned to maximize MOXATAG's market potential, which what prompted us to implement the tele-detailing program for the KEFLEX 750 mg product.

Gross margin on sales was sales was $1.9 million or 87% of net sales for the 2009 second quarter. During the prior year quarter, the gross margin was $2.1 million or 85% of net sales.

The improvement in gross margin percentage reflects the higher overall gross margin rate on MOXATAG as compared to our KEFLEX products. Keep in mind that our $20 max copay program was introduced during the third quarter, so there was no accounting impact during the second quarter.

For the third quarter, we expect that we will need to reduce our net sales as a result of the implementation of the more expensive max copay program, and I will address that momentarily.

Research and development expenses were $1.5 million for the 2009 second quarter, compared to $3.6 million for the same quarter last year. The decrease in R&D expenses over the prior year quarter is primarily driven by reduction in direct project and personnel related expenses.

Selling, general and administrative expense for the 2009 second quarter was $20 million versus $3.9 million in the prior year quarter. The $16.1 million increase in SG&A expense over the prior quarter primarily relates to our increased sales force, managed headcount and MOXATAG marketing programs.

The final result is a net loss for the 2009 second quarter of $19.6 million or $0.23 per common share. This compares to a net loss of $3.7 million or $0.07 per common share during the prior year quarter. For the quarter there were 86.5 million shares used in the EPS calculation. In the prior year quarter there were 56 million shares outstanding.

We started the second quarter with a combined cash and marketable securities balance of $55.4 million, and ended with $44.5 million at June 30, 2009. The decrease is primarily due to an increase in selling, general and administrative expenses as discussed previous, which was partially offset by the collection of the $9.5 million of accounts receivable balance related to the MOXATAG launch that existed at March 31, 2009.

That concludes my review of the second quarter financial results. At this point, I will provide our business outlook for 2009.

As I noted earlier, MOXATAG prescriptions through the week ended July 24, represent about 60% of our cumulative prescription forecast. That prescription forecast was the basis of our previous guidance of $40 million of net revenue for both MOXATAG and KEFLEX.

The most recent data point for the week ended July 24, reflected 2,048 MOXATAG prescriptions, a 30% increase versus the prior week. However, that represents about 60% of our initial forecast for that week.

Additionally, the MOXTAG $20 max copay program results in MiddleBrook effectively reducing its net selling price. Compared to our $15 copay check program for MOXATAG, the initial data suggest that this program may reduce the net sales per prescription by up to an additional $12. Potentially, this results in a net sales amount of $45 per MOXATAG prescription, and a gross margin of $40 per prescription or about an 88% gross margin.

With this in mind, we believe the prudent course of action is to reduce our combined net sale forecast for 2009 to less than $25 million.

Now, on the expense side of the equation, we've made some positive improvements. We had previously estimated that our total operating expense would range between $93 million and a $100 million. We now believe we can control such expenses within the range of $83 million to $88 million. As mentioned in our press release this morning, we've intensified our business development efforts, and at this point, we now anticipate that additional financing may be necessary to pursue such opportunities and/or fund operations.

That concludes our 2009 business outlook, and at this point, I'll open the call up for questions.

Question-and-Answer Session

Operator

(Operator Instructions). Your first question comes from the line of Richard Silver from Barclays Capital. Your line is now open.

Richard Silver - Barclays Capital

Yes. Thank you. A couple of questions. On the operating expense reductions, can you give us a sense of qualitatively what spending is being cut where?

Dave Becker

Yes, Rich. This is Dave. I would say when you look at SG&A and research and development, I would say, it's across the board. I would say keep in mind that the second quarter is the first full quarter with the entire expense structure in place, and when we build the initial estimates, it was an organization of about 30 people projecting to be a 350 person organization. So, in terms of the slant, in terms of estimating, we would have estimated at the high end of that expense range, and based on our actual experience, we've been able to recoup some saving based just off the actual experience.

On product development, as John pointed out, we are currently anticipating a delay in the development KEFLEX PULSYS program. There is at least couple million dollars there, but as you pointed out, we'll need to evaluate how we proceed with that program once we have more information.

Richard Silver - Barclays Capital

Okay. Just on the SPA, can you perhaps elaborate on what it is that you think will be required now in order to get the program back on track?

John Thievon

Yes, this is John. We really are in the evaluation stage of the response from FDA. Certainly, we have seen that the non-inferiority approach, we did not reach agreement with them on their response back to us, but we really are in the early stages of reviewing what our options would be, and how would we proceed relative to success of MOXATAG as well as business development opportunities. So, we really aren't prepared to talk about the different options.

Richard Silver - Barclays Capital

Then on MOXATAG price per script and gross margin. You said 45 and 40 respectively, what was it previously?

Dave Becker

It was about 57 under the old program. The old program being the $15 point-of-sale check program that we launched MOXATAG with. There is still some distribution on the $15 coupon program. Obviously, we've had the max copay program out for, at this point, a little over two weeks, and we have only have data on one complete week. Ultimately, it will come down to the level of utilization or redemption rate. It's probably a little too early to predict exactly what that would be, but the early indication is that, it would be up to an incremental $12 per script, and that's how we got to the $45.

Richard Silver - Barclays Capital

What about the gross margin on the 57?

Dave Becker

As you can see, we've reflected about a $5 cost of goods per prescription. The $5 would not be impacted.

Richard Silver - Barclays Capital

Okay. Maybe you discussed this at the beginning of the call. I apologize I came on late, but what you expect to change with MOXATAG marketing to hopefully get this on a higher trajectory?

John Thievon

Rich, this is John. We've implemented the most visible, the maximum, the $20 maximum copay program which would allow people with insurance, which is the majority of the marketplace, that they would pay no more than $20 per prescription of MOXATAG. We have some early information on that, which looks very promising. Dave indicated a 30% increase in the most current week of prescriptions. We've been receiving some pretty positive feedback from the field, again, very early into the program.

We've really intensified our efforts at the pharmacy level from both the individual retail pharmacies as well as our calls to the headquarter, and we recently announced that we have added the third top chain out there, into an auto distribution to their top amoxicillin, store so that gives us, all three of the majors have MOXATAG on the shelve, in their top stores which was a big win for us.

Our goal is to have bottle of MOXATAG in every shelf where we have sales representative where a prescriptions could potentially land, and we are making some good progress along that way.

Richard Silver - Barclays Capital

On the business development front, which you said, you're going to have to step up your activities there, what sort of products and product categories would you be targeting to complement MOXATAG?

John Thievon

It's a good question. Given that we are a primary care sales force, and we're reaching doctors that prescribe a wide variety of products, the opportunities are in a sense limitless relative to primary care. If a primary care physician has the ability or rights in a therapeutic class, that is certainly something we could look at for either an in-license or co-promote or an acquisition. So, being a primary care sales force opens up a lot of different opportunities and different therapeutic classes given the nature of our (inaudible) universe.

Richard Silver - Barclays Capital

On the last conference call, you talked about the pharmacy awareness, and that there was an opportunity to improve the awareness and therefore improve stocking of the product, no commentary on that this call. What's changed if anything on that front?

John Thievon

Actually, when we talked about the multi-pronged marketing approach, we talked about Pharmacy Choice website, which is really the resource for pharmacist, pharmacy techs, pharmacy managers to get information. We've assumed a position there. We are continuing to do direct mail, e-mail blast, fax blast to retail pharmacies.

Since the last call, we've significantly increased that. We've refocused some of our marketing dollars more to the retail pharmacist. We implemented a strep throat guide which is an agreement with one of the trade publications. It's a guide that talks about strep throat, treatment of it, and that's going to be going out to 100,000 pharmacist and pharmacy techs over the next couple months. Obviously, it is branded piece that talks about MOXATAG being a very good choice for strep throat

The fact that we field over 20,000 prescriptions now and our trade advertising has reached a lot more people. When you talk about MOXATAG in a retail pharmacy, there is a lot more awareness of it, and we are able to get into some deeper discussion at the sales rep level, but we are just going to continue to blast the retailers with MOXATAG information, and most importantly, send prescription to the store to get filled.

As that's continues to happen, the awareness increases, and their ability to bring not only may be one bottle on the shelf but multiple bottle as we enter the strep season. That is the goal, and that's kind of where it's headed. The prescription growth has been a little slower than expected, but we are building nicely, and we feel we were in a good position to execute going into the season, keeping in mind that nobody is going in after us and counter detailing MOXATAG. So, we think that will have impact over time.

We just have to get in front of the doctors more times, we've only been out there a few months, but we are starting to really have some impact, and we are adding unique prescribers each week. In another words; different doctors are jumping on board, and that really will be what will drive business moving forward.

The more doctors writing prescription of MOXATAG over time, the more successful we are going to be. We are currently seeing a very good trend there.

Richard Silver - Barclays Capital

On the doctors, you did also comment on that before that, they were prescribing, the patients won't necessarily filling because of cost or physicians not prescribing, again, knowing the cost. Any update on that front?

John Thievon

It's across the chain. It's really across the channel. The thing that gives me the greatest confidence in the product and the future of MOXATAG is that the healthcare community sees the value in MOXATAG. Upfront, obviously, they would write a prescription and potentially it wasn't at the retail shelf for example. We've addressed the lot of those issues as I mentioned.

We are in the top three chains as well as a lot of regional chains, and a lot of independents. So we are starting to overcome that obstacle. Number two then was, a patient would get there and their copay was a little bit higher than they were comfortable with. We addressed that first with first with the $15 copay point-of-sale program. We've improved that now being able to say to physicians that, none of your patients will pay more than $20 for this prescription, and we think that has really ignited physicians to jump onboard. Again, we only have some early data, but the early data suggest that that has been positively received.

It's also been positively received at the retail point-of-sale because retailers do not want to get into discussions with patients relative to cost. They want to fill the prescription and get the patient out of the store, and with $20 for once-a-day extended release antibiotic that's the best choice for strep, we feel we're in a very good position to minimize those discussions, and most importantly, those walk away.

So, Rich, it's across the board, more awareness for calling on a physician. We are reaching our physicians probably for the sixth and seventh times in the high volume offices. The distribution at the national level is significantly better with those order ship programs. Then we are generating more prescriptions, so people are more aware of the product.

So, it's a process, and we feel we are making good progress on that front. We mentioned it's a little slower than we would have expected. However, as we go into the season, we feel like we are in good position to execute and significantly increase prescriptions.

Richard Silver - Barclays Capital

One more on financing. You say that you may to do a financing. How would you not need to do a financing I guess is the question?

Dave Becker

Let's take an account of where we are at today. 60% of our prescription forecast underlie in the original guidance. When you break that down into absolute numbers, it's about 12,000 prescriptions that we would behind forecast on. Not an insurmountable number, particularly as we move into the season. So, there is still a potential that we get this thing back on track, get up to the market share that we'd like to be at the year.

I think in terms of expediting or putting a little more emphasis on business development, we would recognize that, to get something done there would most likely require some type of additional financing.

Richard Silver - Barclays Capital

Do you hope to have some business development deals announced before the end of the year?

John Thievon

We would hope to. Obviously, that very difficult to predict, nothing to report at this point other than we've been very active.

Richard Silver - Barclays Capital

That would be the goal?

John Thievon

That certainly would be a goal. Yes.

Richard Silver - Barclays Capital

Okay. Thank you.

Operator

(Operator Instructions) There are no further questions at this time.

John Thievon

Thank you for participating in today's call. Our second quarter was a productive one in which we demonstrate strong execution capabilities in a challenging market environment. We produced steady month-over-month gains in MOXATAG prescription volume, and we implemented our patient-centric $20 maximum copay programs to increase our prescription growth rate with positive initial results.

We secured a $10 million working capital line of credit, and reduced our expense estimate for the year, which demonstrates our ability and continued commitments to preserve cash.

Our focus for the remainder of the year is to successfully commercialize MOXATAG, continue to manage our financial resources carefully, and intensify our business development activities. We believe that MOXATAG has long-term value, and it will be successful because MOXATAG meets a real need in the market.

We believe it's an excellent first line choice for treating strep throat, and that we can capture meaningful market share in the upcoming strep season. We appreciate your time today and your interest in MiddleBrook. Thank you very much.

Operator

This does conclude today's conference call. You may now disconnect.

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Source: MiddleBrook Pharmaceuticals, Inc. Q2 2009 Earnings Call Transcript
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