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Executives

Ted Schroeder – President and CEO

Jim Breitmeyer – Executive Vice President and CMF

Scott Byrd – Senior Vice President and CCO

Bill LaRue – Senior Vice President and CFO.

Analysts

Charles Duncan – JMP Securities

Eric Schmidt – Cowen and Company

Adam Cutler – Canaccord Genuity

Joseph Schwartz – Leerink Swann

Irina Rivkind – Duncan Williams

Richard Lau – Wedbush Securities

Cadence Pharmaceuticals Inc. (CADX) Q3 2010 Earnings Call November 5, 2010 8:30 AM ET

Operator

Good morning. And welcome to the Cadence Pharmaceuticals Third Quarter 2010 Financial Results Conference Call. On the call today are Ted Schroeder, President and CEO; Jim Breitmeyer, Executive Vice President and Chief Medical Officer; Scott Byrd, Senior Vice President and Chief Commercial Officer; and Bill LaRue, Senior Vice President and Chief Financial Officer.

At this time, I would like to inform you that this conference is being recorded and that all participants are in a listen-only mode. At the request of the company we will open the conference for question-and-answer after the management presentation. (Operator Instructions)

Our first speaker is Bill LaRue. Please go ahead, sir.

Bill LaRue

Thank you. Good morning, everyone. Before we get started today, I’d like to remind you that statements included in this conference call that are not a description of historical facts are forward-looking statements. Such forward-looking statements include statements regarding our readiness for and anticipated timing for the planned commercial launch of OFIRMEV, OFIRMEV’s market potential and ability to fulfill unmet medical needs, our beliefs that pharmacoeconomic issues will not be a significant barrier to formulary approvals, the sufficiency of our company’s capital resources to fund our operations through the launch of OFIRMEV and our financial estimates or projections.

Our actual results may differ materially from those discussed during this conference call due to the risks and uncertainties inherent in our business which include, our dependence on the successful commercialization of OFIRMEV, the potential that will require substantial additional funding in order to effectively commercialize OFIRMEV, and the risk that we may not be able to raise sufficient capital when needed or at all, the risk that delays in commercially launching OFIRMEV would enable competitors to further entrench their existing products or develop and bring new products to market before OFIRMEV, our ability to ensure an adequate and continued supply of OFIRMEV, and our ability to comply with the terms of and draw down additional amounts under a loan agreement, and the potential for an event of default under a loan agreement, the impact of healthcare reform legislation and our ability to timely complete a required post-marketing efficacy study of OFIRMEV in infants and neonates.

These and other risks are detailed in our prior press releases and periodic public filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements and we undertake no obligation to revise or update such statements. All forward looking-statements are qualified by this cautionary statement.

This caution is made under the Safe Harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. If anyone has not seen our press release issued earlier today, you can access it on our website at www.cadencepharm.com. Additionally, this conference call is being webcast through the company’s website and will be archived there for future reference. Ted?

Ted Schroeder

Thank you, Bill. Good morning, everyone, and thank you for joining us today. I’ll start by discussing the recent FDA approval of OFIRMEV and our ongoing preparations to launch the product. Next Bill will provide an overview of our third quarter and year-to-date financial results, and then we’ll open the call to your questions.

As you know, on November 2nd Cadence achieved a significant milestone with the approval by the FDA of OFIRMEV, a proprietary intravenous formulation of IV acetaminophen for the management of mild to moderate pain. The management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever, OFIRMEV is the first and only form of IV acetaminophen to be approved in the U.S.

In our pivotal clinical trials in patients undergoing hip or knee surgery, OFIRMEV resulted in significantly decreased pain intensity and reduced opioid consumption, as well as improved patient satisfaction when compared to placebo.

We firmly believe that OFIRMEV may benefit hospitalized patients by offering physicians a new non-opioid, non-NSAIDs treatment option for the management of pain and fever.

Our commercial leadership team led by Scott Byrd, our Chief Commercial Officer, and Randy St. Laurent, our VP of Sales, is excited about the positive feedback we’ve received about OFIRMEV from thought leaders across the country, as well as from our market research.

For example, surgeons and anesthesiologists surveyed in 2009 indicated that they would prescribe IV acetaminophen for more than 70% of patients experiencing post-operative pain.

As we have stated previously, we believe that OFIRMEV will achieve robust formulary adoption on the basis of its potential to fill unmet medical needs. In circumstances in which hospitals closely consider pharmacoeconomic benefits, we believe OFIRMEV’s value will be reinforced.

In particular, we’re encouraged by the potential to provide hospital formulary committees with published studies of IV acetaminophen that have demonstrated a reduction in opioid consumption, as well as decreased PACU time, post-surgical ambulation time and time to extubation in the ICU.

Our preparations for the launch of OFIRMEV early in the first quarter of 2010 are well underway. As we shared with you on Tuesday, immediately following the approval of OFIRMEV we initiated the process of hiring our sales team.

By end of day yesterday over 130 hospital sales specialists with an average of 10 years of hospital sales experience accepted employment offers with our company. Most of these individuals are currently working as hospital sales specialists with leading pharma and biotech companies. Our medical affairs Department has received a similar acceptance rate from candidates for our field-based [NFL] team.

We are very pleased by this vote of confidence in OFIRMEV and our company and are very excited about having such an experienced and accomplished team of sales and medical professionals join our team at Cadence.

With that, I’ll turn the call over to Bill who will review our financial results in detail.

Bill LaRue

Thanks Ted. During the third quarter of 2010, we reported a net loss of $11.7 million, compared to $11.4 million for the third quarter of 2009. For the nine months ended September 30, 2010, we reported a net loss of $37.9 million, compared to a net loss of $30.2 million for the first nine months of 2009.

These increases in our net loss during 2010 were primarily due to a significant increase in our sales and marketing expenditures, as a result of our preparations for the commercialization of OFIRMEV. These preparations included adding employees in the sales and marketing area where the headcount was increased from two at the beginning of 2009 to 37 today. As a result our sales and marketing personnel costs increased significantly in 2010.

In addition, we incurred a $1.5 million charge during the first nine months of 2010 related to the partial cancellation of a capital equipment order. Partially offsetting these increases was a decrease in our research and development expenses in 2010 as compared to 2009.

This reduction was primarily due to a decline in expenses related to the discontinuation of our omiganan development program in the first quarter of last year combined with the completion of our clinical development program for OFIRMEV in May 2009. As of September 30, 2010 we held approximately $60 million in cash, cash equivalents and short-term investments.

I’ll not turn the call back over to Ted for his closing remarks.

Ted Schroeder

Thank you, Bill. I’d like to conclude our prepared remarks by once again thanking you for your continued support of Cadence.

We’ll now open the call to your questions. Operator?

Question-and-Answer Session

Operator

Thank you, Mr. Schroeder. (Operator Instructions) Our first question comes from Charles Duncan with JMP Securities.

Charles Duncan – JMP Securities

Hi, guys. Thanks for taking the call. My first question is regarding the pharmacoeconomic analysis that you said that you’re going to be able to provide P&T committees. If you provide us a little bit more color on call it the dollars and cents or the magnitude of I presume a cost savings so that we can evaluate how much flex there’s going to be or interest there’s going to be in the program?

Scott Byrd

Hi Charles. This is Scott. I can give you a little bit of more color, I’m not sure, I’m going to be just the appropriate time to get into the details of the economic modeling. But what we can share is that there are several studies out there that, as Ted mentioned that have demonstrated that there are opportunities to improve resource utilization with the reduction of opioids, with the reduction of PACU time, ambulation time, et cetera.

So, in that context the cost of PACU time to the extent that it’s been published, is around $250 per hour. So, even very modest reductions in the time in the PACU can have pretty substantial offsets in the cost to the hospital relative to the pricing that we’ve talked about previously. Similarly, we have talked a lot about the reduction in opioids and there is a plethora of data that have been published previously on the value of reducing opioids.

Much of this data has been in the context of the previously available therapies of course here in the U.S. like ketorolac and in those studies there was a reduction in cost for hospitals ranging, depending upon the surgical procedure and the patient type about $300 all the way up through $2000 per patient.

So, again without getting into the specifics of applying this to an individual hospital or individual patient, those give you some feel for the magnitude of the impact that has been published for OFIRMEV and then also some of the relative values that have been published in some other studies with the benefits that have been demonstrated for our product.

Charles Duncan – JMP Securities

Okay, Scott. And since I’ve got you, perhaps, you’ve been, I can ask you, you’ve been pretty busy it seems like for the last few months working with or prospective customers. Do you know or do you believe that there are P&T committee meetings that can be had over the course of the first couple of quarters that could enable decisions in the first half of next year?

Scott Byrd

Of course. Yeah. I mean, there’s already we’re aware of some institutions that have begun the process. So, certainly we expect that there will be hospitals making decisions over the next couple of quarters. Again, what we’ve talked about previously is that most hospitals will move through their structured processes, it will be a six to nine months process for most institutions. But we’re absolutely anticipating that some institutions are going to be moving much, much more quickly. And as I think we shared on our last call, it’s our intent to provide some guidance on that at a later point in time and then provide you updates on our performance along the way.

Charles Duncan – JMP Securities

Thanks for the added color.

Scott Byrd

My pleasure.

Operator

Our next question comes from Eric Schmidt from Cowen and Company.

Eric Schmidt – Cowen and Company

Good morning. It sounds like you have a plethora of pharmacoeconomic data to share these P&T committees. Is there anything else that you can imagine they’re going to need to see before you gain formulary clearance?

Scott Byrd

Well, I think, it’s going to be a pretty straightforward process. We’ve spent a lot of time engaging pharmacists, physicians that are members of P&T committees, doing a lot of research with, if you will, mark P&T committees early on and as we’ve gone through that process, we continue to hear very, very consistent feedback. And Ted’s comments were really spot on in his opening remarks.

The primary data and evidence that the formulary committees were expecting them to use are the clinical data. And the reason that I really focus on that is because this is really the first time they’ve had in decades to have a truly new class of IV analgesic to put on their formulary and fill of these unmet needs that they’ve been struggling with.

So that’s really going to be the compelling decision for pharmacies. To the extent that they do want to have some discussion around the economics we feel comfortable that we’ve got sufficient data to provide there. We do have, as again I think we talked about on our call earlier in the week, an AMCP dossier that’s available through our Medical Affairs Department which provides quite a robust review of the clinical data that are available for OFIRMEV, as well as, some of the pharmacoeconomic evaluations that I referenced in the previous answer.

Eric Schmidt – Cowen and Company

What about working with various physician organizations to change guidelines in the post-operative setting for pain management, is that on your agenda?

Scott Byrd

Well, we are expecting that there will be new guidelines that are going to be published. This is, as you I think well know, this is the process that’s run and needs to be run very much by the medical organizations themselves. But it’s our understanding that they’re working on new guidelines, the timing of which we certainly can’t predict. But I feel good given the data that we have available and our interactions with thought leaders around the country that this is a product that they’re going to want to include in those guidelines.

And as you might already know, there are guidelines that exist today through multiple organizations that emphasize the use of a multi-modal approach to pain management. And specifically mention the use of acetaminophen in those guidelines. So, I don’t know that there’s a need to substantially change that guidance but certainly providing some more specificity with the use of IV drug specifically OFIRMEV would be a good thing. It -- we’ll provide updates to you along the way as those institutions and the different health organizations publish their guidance, hopefully in the near-term.

Eric Schmidt – Cowen and Company

And then Ted mentioned 130 acceptances on your sales force, I guess, all over the last two or three days here. That’s good progress. Are you still waiting for others to respond or do you have a few holes to fill?

Scott Byrd

Well, we’ve got just a couple holes or open territories that we need to fill. We have had very, very few folks that have decided that this is not going to be the right opportunity for them mostly because they’ve had their great promotions and career opportunities in their current role.

So, we have -- I think now even north of 130 folks that have accepted, we have less than a handful of territories that we anticipate will be open. And we fully expect to have a full sales force coming into our lunch period. As usual, there might always be one or two territories that are open along the way at any given point during the year. But we, particularly with this information, are feeling really confident about having our full team onboard and ready to launch early next year.

Eric Schmidt – Cowen and Company

Thanks for taking the questions.

Scott Byrd

My pleasure.

Operator

Our next question comes from Adam Cutler with Canaccord Genuity.

Adam Cutler – Canaccord Genuity

Hi. Good morning, guys. Thanks for taking the question. Just wondering, if you can talk a little bit about some of the competitive dynamics in the marketplace and I think there are a lot of investors who have looked at the sales trajectory of Caldolor, for instance and wondered why OFIRMEV could or should do better. And so, I think there are some reasons, but I’m wondering if you could just remind us and kind of give us your perspective on that?

Scott Byrd

Well, this is not a story that’s changed from our perspective since even prior to the approval and launch of Caldolor. And I think as many of the folks probably on the phone know, we’ve talked about how we believe hospitals are going to review and evaluate the product and I think that, in fact, it’s played out very much like our research would have suggested even two years ago.

The economic value of products in today’s environment are evaluated in the context of their therapeutic equivalent, the other options that hospitals have to use. For Caldolor, that product is ketorolac. It’s a very well established and entrenched NSAIDs. Physicians and hospitals have a lot of experience with that product. And it’s our view that physicians just don’t believe that there’s clinical data that offers any differentiating efficacy or safety from ketorolac and remember, this is a product that also carries a black box warning. And that’s something that, again in the context of having to make a decision to bring a new product on to one’s formulary, they are going to evaluate very carefully at a price differential that’s eight to nine times the generic with little differentiation.

I don’t think it’s really a surprise that there’s been a struggle to penetrate the formulary process there. The reason, of course, that we feel comfortable with the approach that we’re taking in OFIRMEV is because, as I mentioned in the last couple of questions, OFIRMEV is highly differentiated from the current products on the market. It’s a non-opioid, non- NSAIDs, carries no black box warning. We think that that will position it quite well to meet unmet needs in the hospitals and be able to allow hospitals and physicians to treat patients where they might otherwise not be able to with the available therapies today.

And certainly the benefit/risk ratio or assessment of OFIRMEV is one that we think provides quite a different opportunity for physicians to consider treating patients across the spectrum of different surgical procedures and that’s something that we believe will have strong support from physicians on. And in our interactions previously through the market research, we’ve gained some confidence that the formulary process will be a positive one for OFIRMEV.

Ted Schroeder

Adam, and I would add that one of the unusual things that we have available to us to benchmark is that we have the performance of IV acetaminophen in Europe in markets where often there are multiple NSAIDs available. And in every one of those markets, OFIRMEV continues to perform in a very robust way. In fact, as you know, IV acetaminophen, it’s not OFIRMEV in Europe.

But IV acetaminophen is the leading IV analgesic in Europe, maintains the dominant unit share and that’s true in countries that are -- where physicians predominantly prescribe NSAIDs, that’s true in countries like the U.K. where physicians predominately prescribe narcotics. In fact, in the U.K., a market that’s very similar to the U.S. where narcotics dominate, there are limited numbers of NSAIDs including diclofenac and ketorolac, but those are the only two available. IV acetaminophen commands a 35% market share of the IV analgesic units in the United Kingdom.

If that was translated into U.S. pricing and U.S. market opportunity that would be a product that would be in excess of $1.5 billion. So I’m not giving guidance to that number, but I’m just pointing out that the physician adoption of the product in markets that mirror the U.S. or in markets that are heavily dominated by NSAIDs seems to be unaffected. It’s the benefits that Scott has outlined of the drug that physicians find compelling for the opportunity to deliver better pain control with reduced opioid consumption.

Scott Byrd

Adam, I’d add one last thing to that and certainly, we believe that OFIRMEV stands alone in its value proposition and that will be the primary reason for a differential launch. However, we have shared multiple times our excitement and really our -- how thrilled we are with the hospital sales team that we’ve been able to build to help launch OFIRMEV. And I think that’s also a differential factor that will help us with the launch of this product.

Again, I’ll just remind you that we’re going to have a substantially higher number of folks promoting this product than that that launched Caldolor and maybe even more importantly, these are folks that have arguably some of the highest average experience in hospital sales of most any other sales force out there at 10 years average sales experience. So these are folks that understand these hospitals extremely well. They’re very well-versed in the hospital formulary process and negotiating through the unique needs of pharmacy, administration, physicians and nurses. And I think that experience as well will certainly benefit us relative to some of the recent launches.

Adam Cutler – Canaccord Genuity

Okay. That’s very helpful. Thanks a lot, guys.

Ted Schroeder

Thanks, Adam.

Operator

Our next question comes from Joseph Schwartz with Leerink Swann.

Joseph Schwartz – Leerink Swann

Hi. Thanks for taking the question. I was wondering if you could remind us of your market research that suggested a price range of $8 to $10 a dose and how that might square with some of the pharmacoeconomic benefits that you can provide customers.

Ted Schroeder

Yeah. So, Joseph, we’ve been throughout the last few years extensively studying the pricing dynamics in the United States and so we’re comfortable with the $8 to $10 price range that seems to be in the proper range. Keep in mind that the average post surgical patients will receive six IV doses over 48 hours. So you’re not looking at a tremendous incremental cost.

I would also remind everyone listening to the call today that in the hospital setting, these types of drugs are managed under a DRG. It is a capitated system. So it’s not a system where you have to seek individual pricing authorization or -- there’s no tiered pricing schedule like you’d see in an outpatient managed-care environment. This is a different -- it’s a capitated environment. So the costs are really from the cost savings that come from the pharmacoeconomics that Scott was talking about earlier.

So you put all that together, let say, you deliver better pain control, better patient satisfaction, which are clearly outcomes that hospitals are focused on. You’re reducing narcotic exposure in patients that’s clearly a benefit and leads to better pain control and better satisfaction.

And evidence of substantial pharmacoeconomic benefits, we think it lines up into all the categories that both clinicians and hospital pharmacy are looking for, so we’re confident in the positioning and as we move forward to the announced price.

Joseph Schwartz – Leerink Swann

Great. Thanks. That’s helpful. Can you give us a sense of which surgery settings you think are most likely to see adoption come first versus later? And are there accounts that view the drug as a line extension since obviously the drug is pretty extensively used elsewhere in their clinics?

Ted Schroeder

Yeah. I’ll answer the last question first. Certainly, there are hospitals that consider it a line extension. And you’re right, they have oral acetaminophen formulary, they have rectal acetaminophen on the formulary. So this is just another dosage form of the same molecule.

So yeah, there are hospitals that will look at it that way. I would say that’s not the majority. I think the particularly larger institutions it will be a formulary review process. And so, that will help to -- as we move through the process. And I’m sorry, Joseph, the second part of your question?

Joseph Schwartz – Leerink Swann

I was just curious which surgery settings you think might be early versus later adopters?

Ted Schroeder

Yeah. So they’re -- we have a broad number of studies -- there are to date 62 randomized controlled trials published with IV acetaminophen, many of those are in surgical settings. So there is evidence of efficacy in abdominal surgeries, in gynecologic surgeries, open-heart surgeries, tonsillectomies, et cetera. And so there’s a really broad range of surgical procedures.

And so, I guess it’s a little hard to predict, but the majority of procedures tend to be abdominal and orthopedic. And those are the areas that have been studied the most widely. So I wouldn’t think it unreasonable to see the earliest adoption in those -- after those types of procedures.

Joseph Schwartz – Leerink Swann

Makes sense. Thank you.

Operator

Our next question comes from Irina Rivkind with Duncan Williams.

Irina Rivkind – Duncan Williams

Hi. Thanks for taking the call. I wanted to explore the formulary profiling a little bit more that you guys have done. I was just wondering if you’ve earned -- just about general hospital scheduling, or if you actually talked to them a little bit about the product and got some indication of willingness to put it on the formulary.

Scott Byrd

Yeah. Irina, of course in a pre-approval situation, we weren’t able to talk specifically about the product. We focus mostly on the processes of the hospital as they make formulary decisions. We did gain a lot of insights into differences from hospital–to-hospital, not only in just the overall formulary process, but the formulary process as it applies to the treatment of acute pain.

And of course there’s a lot of variability from institution to institution and that insights is really going to be pivotal for us as we initiate the launch. So we have, at least in about 900 to 1,000 accounts, very, very deep insights into the structure of their processes, the key members that are involved in the decision-making.

And in many cases of course the folks that are most likely to be champions for the product through that process and the timelines with which we’re anticipating each one of the institutions to move through the process. So all of those details and how we intend to take advantage of them will be the topic of conversation as we get a little bit closer to launch and we’ll provide some more granularity and guidance on that.

Scott Byrd

Yeah. Go ahead.

Irina Rivkind – Duncan Williams

Okay. Go ahead.

Scott Byrd

I was just going to add that the insights we have about willingness to adopt the product come exclusively from market research and we’ve done a lot of market research over the years and it’s remarkably consistent from study to study both here and in Europe. And so the U.S. physician’s perception of efficacy and the utility of OFIRMEV are nearly identical to that European physician’s assessment of its utility.

And I think that’s an important insight that they’re do not seem to be, at least from the extensive market research we’ve done, any significant cultural differences between the continents. In fact, what physicians are looking for is they’re looking for a product that can be used as a foundation of a multimodal approach that will allow them to deliver better pain control while reducing opioid use.

And with that profile we have a number of studies that show that physicians are willing to indicate or indicate that they would place 70% of their postsurgical patients on IV acetaminophen to manage postsurgical pain. That’s a remarkable statistic. It tracks very nicely to the current European use, which is 80% of postsurgical patients receive some doses of IV acetaminophen in the postsurgical setting.

So it’s a product that physicians well understand, it’s the leading -- the leading combination for treating outpatient pain is a combination of acetaminophen and a narcotic. There are 14.4 billion outpatient doses of outpatient narcotics, 75% of those doses are in combination with acetaminophen. And so physicians already recognize the utility of an acetaminophen narcotic combination. In the hospital when patients are unable to take medication by mouth, they now have the opportunity to deliver that same effective approach that they use every day in their hospitalized patients.

Irina Rivkind – Duncan Williams

Great. And, can you provide a little color as to what your reps will be doing while the formulary decisions are underway? Are they going to be talking to physicians on the floors or what are -- what are they going to be doing?

Scott Byrd

Yeah. I’d be happy to share some more about that. This is something where we’ve had conversations before around the -- how one launches a product in the hospital setting. And the answer to that is it will vary from hospital to hospital, of course. There are some institutions that have very specific rules and guidelines about the timing in which representatives can be inside the hospitals and promoting the product and we’re going to adhere to those expectations and guidelines with hospitals.

But all in all I am quite confident that our representatives will be able to advance both the formulary process and the pull-through for demand. In fact, these processes really go hand in hand and are part of the same conversation. So, I don’t really envision this, as others have discussed in other firms, that this is a two-step process where you can only discuss formulary for some period of time and then you move on to discussing the product’s use and pulling through on demand.

This is an approach that’s really is just part of a larger selling cycle. And the representatives are going to be selling the product in hospitals while they’re helping the physicians and pharmacists move OFIRMEV through the formulary process.

Irina Rivkind – Duncan Williams

Great. I just have a quick housekeeping question in terms of expenses for the next quarter. Should we be expecting a manufacturing start or any charges on the COGS line or significant increases in SG&A in the fourth quarter?

Bill LaRue

You will see an increase in SG&A in particular, as we hire the sales force. So, yeah, you will see a ramp there in terms of the expenses. As we build some supply going into next year in terms of product we’ll have some inventory, not a significant number, but we’ll have some inventory on the balance sheet. So you will start to see those changes in the fourth quarter.

Irina Rivkind – Duncan Williams

Thank you.

Operator

Our next question comes from Richard Lau with Wedbush Securities.

Richard Lau – Wedbush Securities

Hi, guys. Thanks for taking my question. Just a quick one for you. Can you guys tell us what medical conferences over the next year or so that you plan on being at?

Scott Byrd

Some of those details for the launch and our promotional plans we can share a little bit more as we get closer to the launch period and share the details and provide the guidance on our launch activities. I think that probably would be the best time to get into some of those details. And if you’ll hang in there with us for just a few more weeks as we head into that stage early next year, we can provide some of those specifics.

Richard Lau – Wedbush Securities

All right. Sure. Thanks, guys.

Operator

At this time, there are no further questions, so I’ll turn the call back over to Mr. Schroeder.

Ted Schroeder

Well, thank you, everyone. Thank you for joining the call today. Your continued -- and thank you for your continued support and interest in Cadence.

Operator

Ladies and gentlemen, this concludes our conference. All parties may now disconnect.

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