Inspire Pharmaceuticals, Q2 2008 Earnings Call Transcript

Inspire Pharmaceuticals, (NASDAQ:ISPH)

Q2 2008 Earnings Call Transcript

August 11, 2008 10:00 am ET

Executives

Jenny Kobin - VP of IR and Corporate Communications

Thomas Staab - CFO and Treasurer

Christy Shaffer - President and CEO

Analysts

Joseph Schwartz - Leerink Swann

Duane Nash - Pacific Growth Equities

Dave - Morgan Stanley

Serge Belanger - Susquehanna Financial Group

Operator

Good morning. My name is Nicole, and I will be your conference operator today. At this time I would like to welcome everyone to the Inspire Pharmaceuticals Second Quarter 2008 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer period.

(Operator Instructions) As a reminder, ladies and gentlemen, this call is being recorded today, Monday, August 11th 2008. Thank you.

I would now like to introduce Ms. Jenny Kobin, Vice President of Investor Relations and Corporate Communications. Ms. Kobin, you may begin your conference.

Jenny Kobin

Good morning, and thank you for joining Inspire Pharmaceuticals’ second quarter 2008 financial results conference call.

We will begin by reminding you that the forward-looking statements in this conference call are based on preliminary information and management assumptions. These forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those related to product commercialization; product development, revenue; expense and earnings expectations; competitive products; adverse litigation and regulatory development; results of clinical trials; the need for additional research and testing; funding; and the timing and content of decisions made by regulatory authorities, including the US Food and Drug Administration and the Securities and Exchange Commission.

Further information regarding factors that could affect our results is included in our press releases and in filings with the Securities and Exchange Commission, including our most recent 10-K, 10-Q and 8-K. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements.

On today's conference call we have President and CEO, Dr. Christy Shaffer, and CFO and Treasurer, Tom Staab. For today's call, Tom will begin with a review of our second quarter 2008 financial results, and then Christy will provide an update on our key commercial and clinical programs.

I would now like to turn the call over to Tom.

Thomas Staab

Thank you, Jenny and good morning, everyone. I am pleased to provide you with an overview of our second quarter 2008 financial results, as well as to reaffirm our previously disclosed 2008 operating results guidance. In summary, we are pleased with our second quarter results, and have closed a successful quarter. Specifically, some highlights from the quarter were one, we had strong revenue performance with continued double-digit revenue growth, with revenue increasing 43% over the second quarter of 2007. Two, we increased AzaSite revenue, with product sales increasing 79% from the first quarter of 2008, and three, we maintained tight management of our operating expenses and cash utilization, for which both measures decreased 22% and 52% respectively as compared to the first quarter of this year.

For the quarter ended June 30, 2008, we incurred a net loss of $6.4 million or $0.11 per share, as compared to a net loss of $5.9 million or $0.14 per share for the second quarter of 2007. Total revenue for the second quarter of 2008 was $22 million compared to $15.4 million for the second quarter of 2007, representing a 43% increase in aggregate revenue as I mentioned earlier. When breaking down revenue into its individual components, AzaSite had strong quarterly performance with revenues increasing 79% and prescriptions increasing 59%, both measures as compared to the first quarter 2008 levels. AzaSite has achieved 2% aggregate market share of all branded and generic bacterial conjunctivitis prescriptions, and 5% market share in eye care specialists or opthalmologists and optometrists, where we focus the majority of our time.

All measures mentioned are based upon weekly IMS data for the week ending June 27, 2008. As we look at the aggregate bacterial conjunctivitis market for 2008, total year-to-date volume of prescriptions has decreased approximately 2% as compared to the first six months of 2007. During the second quarter of 2008, we recorded $4.1 million in AzaSite revenue as compared to no revenue in the second quarter of 2007. We are pleased to see the increase in prescriptions, as it is gratifying to see physicians' understanding of AzaSite's unique product profile and their appreciation of the distinguishing qualities of the product compared to other antibiotics. In a minute, Christy will provide a more in-depth discussion of our recently completed Phase 4 AzaSite studies, which represents a glimpse of the product's unique profile.

Moving on, our aggregate co-promotion revenue increased 8% to $16.7 million as compared to $15.4 million for the second quarter of 2007. We recorded $8.9 million of co-promotion revenue from the sales of Restasis, and $7.8 million of co-promotion revenues from sales of Elestat in the second quarter of 2008. Consistent with the situation in the first quarter, we are working to satisfy our 2008 annual contractual minimum, and have deferred $2.6 million of our entitled Elestat revenue from the first six months of the year. As we make progress towards achieving the 2008 minimum, we record Elestat revenue at an escalating rate until we achieve the annual sales minimum. Since we are on track to achieve the sales minimum, we expect to recognize all currently deferred Elestat revenue before the end of the year.

Moving on to a more detailed discussion of the individual products, we continue to be extremely pleased with the growth of Restasis, with prescriptions continuing to grow quarter-over-quarter and increasing 12% in 2008 as compared to the second quarter of 2007. In the second quarter of 2008, Allergan reported $121 million of revenue from Restasis, reflecting a 55% increase over the second quarter of 2007. This growth is fueled by both increased numbers of prescriptions as well as prescribers, and Restasis is now the second-largest opthalmic pharmaceutical in the United States as measured in dollars.

Importantly, Allergan has amended and increased their 2008 revenue expectation for Restasis, with a new expected range of $420 million to $440 million, reflecting a substantial increase from the previous range of $375 million to $405 million. Based upon the geographic mix of Restasis sales and our contractual co-promotion rates, we expect to report revenue of approximately 7% of aggregate 2008 Restasis revenue, and would expect this percentage to remain the same in the future. Restasis continues to be an important product for us, and is expected to represent the largest revenue stream of our three products in 2008.

Elestat is considered a mature product in terms of its product life cycle, but continues to be a reliable contributor to our co-promotion revenue. Accordingly, we expect Elestat to remain at 7% to 8% market share in 2008. As discussed in previous calls, we do not expect a generic entrant to the marketplace right way, although the timing of Elestat's exclusivity is somewhat difficult to predict, and is dependent on the timing of a generic application and the length of FDA review of this application.

As you compare 2008 performance to 2007, you will notice our Elestat revenue has been impacted by a weaker allergy season through the second quarter, with the prescription allergic conjunctivitis market decreasing a little over 10% compared to the halfway mark of 2007.

The final component of our revenue which was previously announced in June was $1.25 million of collaborative research and development revenue received from our Asian region diquafosol partner, Santen. If Santen's diquafosol product is approved, we will receive royalties on net sales of diquafosol in Japan. Now let's move down the income statement for a discussion of our operating expenses.

In the second quarter of 2008, operating expenses increased to $27.9 million from $21.4 million in the second quarter of 2007. This increase was slightly below the increase in revenues, and primarily represents increased development spending and commercial expenditures. The increase in commercial spending is largely associated with expanding the size of our commercial organization to approximately 100 sales representatives, and other promotion activities necessary to commercialize AzaSite. Our development spending was heavily focused on our Denufosol and Prolacria programs, for which Christy will give an update shortly.

Focusing on the balance sheet, we ended the quarter with $94 million in cash and investments and working capital of $73 million. Our net cash burn for the second quarter of 2008 was approximately $15 million, and reflected a $16 million decrease from our first quarter burn, as we narrowed our development spend and achieved greater revenue volume. Finally, as mentioned at the onset of the call, we would like to reaffirm our 2008 financial outlook which is detailed in our press release, and remains the same as the guidance originally presented in February of this year.

Now I would like to turn the call over to Christy for a detailed program update.

Christy Shaffer

Thank you, Tom, and good morning, everyone. The second quarter proved to be quite productive for us resulting in multiple positive events to report, as outlined in our press release this morning. Those included the positive Phase 3 study results in our CF program; a regulatory filing in Japan by our Asian dry eye partner, Santen; a series of positive Phase 4 studies with AzaSite, and as you have just heard from Tom, growing product revenue.

This morning I will first provide you with an update on the Denufosol program, which has been very exciting given the announcement of positive results from our first pivotal trial, TIGER-1, in June. As a product candidate that emanated from our own internal R&D efforts, we currently have worldwide rights for Denufosol, which has a novel mechanism of action and an extensive intellectual property position. I will begin with the high-level overview of our previous announcement regarding the TIGER-1 results, and then provide you with more details on our current plan for the program.

As you are all aware, we announced that the TIGER-1 clinical trial, which enrolled 352 patients with CF lung disease, met its primary efficacy endpoint, which was a change from baseline in FEV1 in liters at the 24-week trial endpoint.

The availability of the extensive data set from TIGER-1 provided us with an excellent opportunity to optimize the design of the second ongoing trial referred to as TIGER-2. Based on review of the data with key experts, including representatives from the CF Foundation, the therapeutic development network and several clinical investigators, we determined that a longer treatment period of 48 weeks was the appropriate length for the TIGER-2 trial. This was based on the observation that there were progressive improvements from baseline in FEV1 of certain patients who received Denufosol in both the 24-week placebo-controlled period as well as the 24-week open label safety extension in TIGER-1.

Of note, is that further analysis of preliminary data available in July of this year from patients who received Denufosol for the full 48 weeks, the main change from baseline in FEV1 more than doubled when compared with the 24-week trial endpoint. We use this information, combined with conservative assumptions regarding the expected standard deviation around FEV1 and a potential dropout rate for a longer trial of 48 weeks, to determine the updated trial size of 450 patients. The decisions regarding protocol modifications to TIGER-2 were balanced from the perspective of increasing the trial's likelihood for success, while moving the program forward as expeditiously as possible.

Our strategy to achieve rapid enrollment in TIGER-2 includes the following steps. First, we held a clinical investigators meeting this past weekend to review the amended protocol in detail. Second, we are working closely with all sites to assist in the timely IRD review and approval of the amended protocol. At this point, we expect the majority of the 90 clinical sites to be able to enroll patients in TIGER-2 by the end of this year. Third, although there is no specific regulatory requirement to do so, we plan to offer patients completing TIGER-2 an option to receive Denufosol through participation in a subsequent open label trial.

And finally, we continue to work very closely with our colleagues at the CF Foundation to create strong interest in TIGER-2 and awareness of the opportunity to enroll in this trial. Thus, I believe we have made excellent progress with regard to optimizing the design and moving forward with enrollment in TIGER-2.

However, at this point in the process it is premature to make definitive timing projections. But based on the changes in the protocol, the availability of TIGER-2 results will be highly dependent on the rate of enrollment in trial, but will likely follow receipt of the final study report of the ongoing required two-year carcinogenicity study in rodents. That final carcinogenicity study report is expected to be available in the second half of 2009, as we have stated previously. We will, of course, be providing you with periodic updates as we proceed with the enrollment process in TIGER-2.

As previously announced, we believe it is important to have a detailed results from the TIGER-1 trial presented in a proper scientific forum, which will be the North American CF Conference scheduled for October 23rd to the 25th in Orlando. I am pleased to confirm today that the TIGER-1 results will be highlighted in the plenary session given by Dr. Preston Campbell, Executive Vice President of Medical Affairs at the CF Foundation, on Friday, October 24th, and will be presented in more detail on Saturday, October 25th by Dr. Frank Accurso, Pediatric CF Center Director at Denver Children's Hospital, and a lead PI of TIGER-1. We also announced last week that a summary of the clinical work with Denufosol that led up to the Phase 3 program was recently published in the August issue of the peer-reviewed journal Pulmonary Pharmacology and Therapeutics.

Now I will move on to Inspire's dry eye clinical program. The continued success and growth of Restasis reinforces the large potential of this market. Both Inspire and our dry eye partner, Allergan, are committed to being leaders in this area and continue to believe it is worthwhile to pursue Prolacria as a potential new treatment for the disease. Like Denufosol, Prolacria came from our own internal R&D efforts and has an extensive intellectual property position.

As you know, we have taken a step-wise and methodical approach in conducting preliminary clinical work to define appropriate primary endpoint and trial design to be used in an additional pivotal Phase 3 study with Prolacria. During the first half of this year, we conducted a pilot clinical trial evaluating Prolacria to gain additional information, and we are now in the process of analyzing data from this pilot trial, and are on track to provide an update on this program by the end of the third quarter of 2008.

In addition to our dry eye program here in the United States, I would also like to remind you of the significant progress being made on the development of a formulation of the same molecule, diquafosol tetrasodium, in Asia. Our partner, Santen Pharmaceutical Company, is responsible for developing, gaining regulatory approval and commercializing diquafosol, which they refer to as DE-089, for dry eye disease in Japan and nine other Asian countries including China, South Korea, the Philippines, Thailand, Vietnam, Taiwan, Singapore, Malaysia, and Indonesia.

In May of this year, Santen completed its Phase 3 clinical trials of DE-089, and as Tom mentioned, we received a related milestone payment. Importantly, Santen filed an application for marketing approval of DE-089 with regulators in Japan on May 30th of this year.

The Japanese equivalent of the FDA, the Ministry of Health, Labor and Welfare, has a review process which is typically 18 to 24 months. Santen stated in their recent investor meeting that it expects to launch this potential dry eye product in its fiscal year 2010, which is between April of 2010 and March of 2011.

Santen, a premiere opthalmic company in Japan with an excellent track record in developing and commercializing opthalmic products, commands a very impressive 80% share of the current Japanese dry eye market. According to Santen, dry eye disease is quite prevalent in the Asian population, with 8 million dry eye patients in Japan alone.

Finally, I would like to take the opportunity to provide you with an update on our AzaSite Phase 4 program. Our opthalmic R&D team has been diligently pursuing work that will substantially expand the scientific database on AzaSite through a comprehensive series of Phase 4 studies. These studies are aimed at further evaluating a profile of the azithromycin molecule, as well as the safety and efficacy of AzaSite in other ocular indications such as lid margin disease, which includes meibomian gland disease and blepharitis.

We have recently received positive results from three additional Phase 4 studies, with additional studies underway. First, I would like to discuss the results from the pharmacokinetic study evaluating the concentration of AzaSite following a full nine-drop course of treatment.

In this open-label study involving 127 patients, conjunctival concentrations were high and sustained, even several days following the last dose of AzaSite. This trial provided further evidence of the very unique PK profile of azithromycin in the DuraSite formulation.

Second, a multi-center open-label trial evaluated the efficacy of AzaSite in treating the signs and symptoms of 26 patients with both meibomian gland disease and anterior blepharitis. In this trial, both the signs of lid margin disease, such as eyelid margin redness and plugging of the meibomian gland disease and the symptoms such as itching, foreign body sensation, ocular dryness and burning, and swollen eyelids all showed statistically significant improvements from baseline after four weeks of treatment with AzaSite.

Further, a single-center open-label study in 21 patients demonstrated that AzaSite combined with a standard treatment regimen involving warm compresses brought a statistically significant improvement in various signs and symptoms when compared to that standard regimen alone in patients with meibomian gland disease, also known as posterior blepharitis, following only two weeks of treatments.

The latter two Phase 4 studies were small and not placebo controlled. Therefore, additional studies are needed to confirm and extend these preliminary findings. Manuscripts for the three studies described are being prepared and will be submitted for publication as soon as possible.

In summary, we have made progress in the second quarter in a number of our programs, addressing unmet medical needs. First, we are moving forward aggressively with our plans to maximize the potential of denufosol for CF following the positive results from the first Phase 3 trial.

Second, we are in the process of conducting our analysis to determine the optimal clinical path forward for Prolacria for the treatment of dry eye disease in the United States. And three, we are expanding on the scientific data of AzaSite through a series of Phase 4 studies to better understand the full product profile.

That concludes our formal remarks this morning, and we will now open the call for questions.

Question-and-Answer Session

Operator

(Operator Instructions). Your first question comes from the line of Joseph Schwartz with Leerink Swann.

Joseph Schwartz - Leerink Swann

Hi. Good morning. Congratulations on all the progress. I was wondering, first on denufosol, did you actually hold a meeting with the FDA and discuss whether the second confirmatory trial would be necessary, given the unmet medical need in this area? It would seem like with such strong results from TIGER-1, you could potentially almost file on just that first study.

Christy Shaffer

Thank you, Joe. I appreciate the question, and I appreciate your positive view of the data, which of course is certainly true. However, I think that our understanding of what’s s required from an FDA perspective is two trials, and again we are required to complete two-year inhalation carcinogenicity study in rodents as well. So, our plan is to conduct the two trials, and we think that will give a very robust package for an NDA submission.

Joseph Schwartz - Leerink Swann

Okay. So then next on AzaSite and blepharitis, we’ve definitely sensed some excitement from the community and some increasing use even before this data is potentially on the label. Do you have any plans to submit it and have it be approved for an indication officially?

Christy Shaffer

Joe, that’s another excellent question. We are continuing to explore studies for AzaSite, and I should again reiterate that the studies we have conducted to date and others have conducted to date, there are some independent studies that have already been completed as well and some have appeared in the Ophthalmology Times. Those are non-placebo controlled trials.

So, as we begin to gather more information, we have a few studies ongoing, we will be looking at that data. We will be assessing the potential market for blepharitis, which is a recurrent, largely a recurrent condition. And we would obviously need to have discussion with the FDA regarding what pathway might be available for an indication. There are no currently approved agents for various forms of blepharitis. So, it’s an interesting area to explore, but we need a bit more data.

Joseph Schwartz - Leerink Swann

Okay, great. That’s very helpful. I’ll get back in the queue. Thank you.

Operator

Your next question comes from the line of Duane Nash with Pacific Growth Equities.

Duane Nash - Pacific Growth Equities

Hi, Christy. Congratulations on the progress.

Christy Shaffer

Thank you.

Duane Nash - Pacific Growth Equities

Two accounting related questions. The first is the $2.6 million in deferred Elestat revenue. I was wondering if you could disclose how much of that was booked in the current quarter.

Christy Shaffer

Thank you very much, Duane. I’m going to ask Tom Staab to address that question.

Tom Staab

Hi, Duane. One question, I didn’t get the very tail end of that question. You were talking about the $2.6 million deferred Elestat. What was the question?

Duane Nash - Pacific Growth Equities

Can you disclose how much of that was booked in current quarter – I’m sorry, Q2?

Tom Staab

Yes, we do not disclose that amount. It’s very difficult to do, because as we get closer to the annual minimum it escalates up. And so it becomes a pretty problematic conversation, or calculation to do. But there is, part of the 2.6 is from the first quarter and part of it is from the second quarter.

Duane Nash - Pacific Growth Equities

Okay, thanks. Second question is about inventory levels of AzaSite. The sales you reported were very strong, in fact, quite stronger than we ourselves had predicted. We were wondering what level inventory could play in that very strong result?

Tom Staab

Sure. We too were pleased with AzaSite performance in the second quarter. We’ve had a lot of a formulary wins. There are more physicians prescribing AzaSite. And specifically, in response to your question on inventory levels, we did have an increase based on inventory levels that we look at very carefully; not only in the wholesaler pipeline but also in the retailer.

Now, I’ll say that we’re able to monitor the wholesaler, and it increased about 30%. But those wholesale levels are still running under three weeks, which we think is a very reasonable level. And so, there was some contribution to revenue from inventory billed, but it only is in proportion to the increase in script levels.

Duane Nash - Pacific Growth Equities

Great. Well, thank you very much.

Operator

(Operator Instructions). Your next question comes from the line of Sapna Srivastava with Morgan Stanley.

Dave - Morgan Stanley

Hi. It’s Dave calling in for Sapna. Just a quick question, on the cost of goods. It looks like the cost of goods as a percent of AzaSite sales have been fluctuating a little bit. I was wondering if you could just comment on what’s causing some of the changes as a percent of the sales, and where you think a reasonable settling point is for this drug?

Christy Shaffer

Thanks for the question. Tom will address that one.

Tom Staab

Sure, Dave. Actually, the cost of goods sold hasn’t been fluctuating too much. It’s been running around 40%. And if you remember, there is two things that are in there. One is the actual royalty that we owe InSite Vision, which is currently at 20%, as well as the amortization of the approval milestone, which is amortized over the patent life of the product.

So as AzaSite revenue increases, we would expect the cost of goods sold to come down for two reasons. One, because the amortization of that milestone is spread over a larger revenue base; and two, the overheads that we charge in the cost of goods sold for managing the supply chain would not be variable to the dollars. And as the dollars increase that proportion of cost of goods sold would decrease.

Now with all that said, our royalty rate will go up to 25% to InSite Vision, and so you’ll have to factor that in your calculation.

Dave - Morgan Stanley

Okay. Great, thank you.

Operator

Your next question comes from the line of Joseph Schwartz with Leerink Swann.

Joseph Schwartz - Leerink Swann

Hi. Thanks for taking the follow-up. I was just curious now on diquafosol and the ongoing pilot study, if you could talk about that a little bit more and give us some insight into what the potential scenarios could be, since that is a pretty large study and it’s randomized, placebo-controlled, and you have all the other data in the past, that would seem in a representative patient group. Is there any way that if those results were extremely strong that you could see yourselves filing on that data, or under what scenario? What would you have for that to happen versus to run another Phase 3? Thanks.

Christy Shaffer

Okay. Thank you, Joe, an excellent question. First of all, just to reiterate that that the study that we’re doing in this chamber model is - we’d have always described as a pilot study. And it was a lot of information that we wanted – there were a lot of things we wanted to explore in that study in terms of understanding the effect that we would have in the central corneal region. That’s the area that we’re focusing in terms of a future pivotal trial and endpoint.

I think that the data would have to be extremely strong and hit high statistical significance in order to assume we could file on it. So, we’ve always assumed that’s going to be a study that would provide us with the necessary information to figure out the next steps forward.

Joseph Schwartz - Leerink Swann

Okay, great. Thanks.

Operator

Your next question comes from the line of Angela Larson with SIG.

Serge Belanger - SIG

Good morning. This is actually Serge Belanger for Angela. On the CF program, what kind of data can we expect from the TIGER-1 study at the medical meeting in October? And also, are you planning to present any results from this safety extension study?

Christy Shaffer

Yes. Thank you very much for that question. We do plan on presenting information regarding the safety extension. So, we have not planned a full presentation at this point. We’re going to be working with both, doctors Campbell and Accurso on those presentations in the coming months. But, we believe it’s very important, in particular, obviously in addition to showing the safety data, to describe and show you the efficacy data, not only in the 24 weeks randomized portion of the trials, but the data that we would have up to that point in terms of the safety extension, because there you can see the very nice progressive improvements that we’ve seen in terms of a change in baseline in FEV1, and can provide I think a very good visual for why we decided to extend TIGER-2 to 48 weeks.

Serge Belanger - SIG

And will the safety extension study be almost completed by that time?

Christy Shaffer

Jenny?

Jenny Kobin

Yes, that will be completed in October.

Serge Belanger - SIG

Okay.

Jenny Kobin

Completed enrollment a year ago in October.

Serge Belanger - SIG

Okay. Thank you.

Operator

(Operator Instructions). There are no further questions at this time. Dr. Shaffer, do you have any closing remarks?

Christy Shaffer

Well, thank you very much for your continued interest in Inspire and your participation on the call today. We remain very excited about our innovative programs that we think will make a meaningful difference to patients and provide significant upside to investors as we progress them. And we’ll certainly be providing you with any substantive updates when they become available. Have a great week.

Operator

Thank you for participating in today’s Inspire Pharmaceuticals second quarter 2008 financial results conference call. You may now disconnect.

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