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Executives

William R. LaRue – Senior Vice President, Chief Financial Officer, Treasurer and Assistant Secretary

Theodore R. Schroeder – President, Chief Executive Officer and Director

Scott A. Byrd – Senior Vice President and Chief Commercial Officer

Analysts

Eric Schmidt – Cowen & Co. LLC

Michael W. Schmidt – Leerink Swann LLC

Louise Chen – Guggenheim Securities LLC

David M. Steinberg – Deutsche Bank Securities, Inc.

Ami Fadia – UBS Securities LLC

Greg D. Fraser – Bank of America Securities/Merrill Lynch

Cadence Pharmaceuticals, Inc. (CADX) Q3 2012 Earnings Call November 5, 2012 4:30 PM ET

Operator

Good afternoon and welcome to the Cadence Pharmaceuticals’ Third Quarter 2012 Financial Results Conference Call. On the call today are Ted Schroeder, President and CEO; Bill LaRue, Senior Vice President and Chief Financial Officer and Scott Byrd, Senior Vice President and Chief Commercial 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 up for questions and answers after the management presentation.

Our first speaker is Bill LaRue. Go ahead, sir.

William R. LaRue

Thank you, good afternoon everyone. Before we begin, I would like to remind you that statements included in this conference call that are not a description of historical facts are forward-looking statements. Forward-looking statements include statements regarding financial guidance, expectations regarding sales and demand, formulary approvals, revenue growth, expenses and the market opportunity for OFIRMEV.

Our expectation that our post-approval pediatric clinical trial of OFIRMEV will increase our research and development costs in the coming quarters, while our selling, general and administrative expenses in the fourth quarter will be similar to the third quarter, and the impact of Hurricane Sandy on our business and revenues. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the day hereof.

Our actual future results may differ materially from our current expectations due to the risks and uncertainties inherent in our business. These risks are detailed under Risk Factors in our most recent Form 10-Q and elsewhere in our periodic reports and other filings made with the Securities and Exchange Commission from time-to-time. All forward-looking statements are qualified in their entirety by this cautionary statement which is made under the Safe Harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and we undertake no obligation to revise or update the information disclosed during this call to reflect events or circumstances after this call.

If anyone has not seen our press release issued earlier today, you can access it on our website at www.cadencepharm.com. We also post and maintain the current version of our corporate presentation on the Investors portion of our website under events and presentations and then corporate overview. Additionally, this conference call is being webcast through our website and will be archived there for future reference. We use the Investors portion of our website as one means of disclosing material non-public information, so we encourage you to monitor our website in addition to following our press releases, SEC filings, and public conference calls and webcasts.

Ted?

Theodore R. Schroeder

Thanks Bill. Good afternoon everyone and thank you for joining us today. I will open by providing a brief overview of the third quarter. Next, Scott will provide an update on our commercial activities for OFIRMEV and then Bill will discuss our financial results. Following our prepared remarks, we will open the call to your questions. I’m very pleased to report that OFIRMEV continued its growth trend during the third quarter. Our net product revenue increased to $13.9 million, which was in the middle of our guidance range of $13.7 million to $14.2 million. This represents an increase of $2.8 million, or 25% compared to the second quarter of 2012. In addition, our gross margin for OFIRMEV has improved to 56% in the third quarter, compared to 48% in the second quarter of this year. This improvement was a result of the economies of scale, efficiencies and a modest price increase taken in July.

In addition to the growth in our net product revenue and gross margin, we also saw a 10% increase in the customer base for OFIRMEV, as compared to the second quarter. We now have a total of nearly 3,500 unique customers and we are on formulary, at over 2,000 institutions. We believe our early efforts to secure formulary wins, and educate health care professionals, are contributing to OFIRMEV’s growing commercial success.

At this point, I would like to turn the call over to Scott, who will discuss our commercial operations and sales performance during the third quarter.

Scott A. Byrd

Thank you. We sold approximately 1.4 million vials of OFIRMEV in the third quarter of 2012. This represented an increase of nearly 225,000 vials or 20% as compared to the previous quarter. This has opened an additional market share gain in OFIRMEV’s quarterly IV analgesic unit market share with 2.35% in the third quarter, versus 1.93% in the second quarter. We believe that these trends are direct result of the growing acceptance of OFIRMEV as the foundation of a multi model approach to acute pain management.

We’ve previously discussed the three key drivers that we believe account for the growing demand for OFIRMEV, growth in the number of new customers, increasing order frequency and increasing average quantities of product ordered by our customers. We’ve made improvements in each of these areas during the third quarter.

The number of unique accounts that had ordered OFIRMEV as of September 30 of 2012 increased to nearly 3,500 accounts, which is up approximately 10% from the end of the second quarter of 2012 and nearly double the number of accounts at the end of the third quarter of 2011. OFIRMEV is now being used in nearly three out of four of the top 2,000 hospitals in the United States, and ranked by the quantity of IV analgesic products purchased.

We believe that this is indicative of physician demand for new methods to manage pain, and the recognition of the role that OFIRMEV can play in acute pain management. The number of our repeat customers also continues to climb. As of September 30, of this year, over 2,800 accounts or 81% of our customers have placed multiple orders for OFIRMEV. This represents an increase of more than 300 accounts over the previous quarter. Average order frequency for all customers grew slightly to 4.5 quarters during the third quarter, driven by a 7% increase in the order frequency by existing customers.

Finally, our average order size has continued to increase, with an increase of approximately 7% during the third quarter as compared to the second quarter.

In summary, during the third quarter, we had more hospital customers placing orders, they ordered increasingly larger quantities, and they placed more orders than in the second quarter. We are also encouraged that many of our customers appear to be shifting away from the adoption phase and toward a broader use of OFIRMEV. We believe that the positive experience that physicians are having with our products are leading them to use OFIRMEV in a wider variety of patients in surgical procedures.

As we previously reported, we announced 6% price increase for OFIRMEV in July that raised the wholesale acquisition cost to $11.40 per vial. It was the first price increase for OFIRMEV since its launch in January 2011. We believe that the timing and the amount of price increase were in line with other recent pharmaceutical product launches and reflect the value of our product to patients. After a few months of experience, the price increase seems to have been well observed in the marketplace. Our commercial team continues to deliver strong results and this was evidenced again during the third quarter. We continue to work diligently in order to establish OFIRMEV as the foundation for a multi-modal approach to acute pain management.

I will now turn the call over to Bill who will review the financial results. Thank you.

William R. LaRue

During the third quarter of 2012, we achieved net product revenue of $13.9 million, which is an increase of $2.8 million or 25% from the $11.1 million from the second quarter of 2012, an increase of $10.4 million from $3.5 million for the third quarter of 2011. For the nine months ended September 30, 2012, our net product revenue was $33 million, which is an increase of $27.4 million from the $5.6 million for the nine months ended September 30, 2011. During the third quarter of 2012, we reported a net loss of $15.9 million, or $0.19 per share, compared to a net loss of $21.8 million or $0.34 per share for the third quarter of 2011. For the nine months ended September 30, 2012, we reported a net loss of $59.6 million or $0.70 per share, compared to a net loss of $65.4 million or $1.03 per share for the comparable period in 2011.

Our cost of sales for the three months ended September 30, 2012 was $6.1 million or approximately 44% of net product revenue, which compares to 65% for the same period in 2011. The reduction in costs was mostly attributable to increased efficiencies from higher production volumes, while our net product revenue benefitted from a higher net selling price due to a price increase in July 2012.

During the 2012 period, our cost of product sales was also negatively impacted by an accrual for minimum royalty obligations. For the nine months ended September 30, 2012, our cost of product sales was $16.1 million or approximately 49% of net revenue, which compares favorable to 64% for the comparable period in 2011. This reduction in cost was mostly attributable to increased efficiencies achieved in 2012 from higher production volumes, which were partially offset by higher freight costs resulting from our temporary supply disruption during the first quarter of the year, unabsorbed manufacturing costs and an inventory write-down. These excess costs were primarily related to our previously reported suspension of production at our initial contract manufacturer’s facility.

Our research and development expenses were $2.2 million for the three months ended September 30 2012, an increase of $500,000 as compared to $1.7 million for the same period in 2011. This increase primarily resulted from severance obligations from departure of two of our officers in connection with our current focus on commercialization, rather than new product development and included approximately $300,000 of non-cash compensation expense.

For the nine months ended September 30, 2012, our research and development expenses were $5.4 million, a decrease of $1.6 million as compared to the $7 million for the comparable period in 2011. This reduction was primarily attributable to the workforce restructuring implemented in the fourth quarter of 2011, partially offset by the severance charges incurred during the third of 2012. Also during the third quarter, we began enrollment in a post-approval clinical trial of OFIRMEV in pediatric patients under two years of age. We anticipate this new study will increase our R&D costs in the coming quarters.

Our selling, general and administrative expenses increased by $100,000 to $20 million for the three months ended September 30, 2012, as compared to $19.9 million for the three months ended September 30, 2011. For the nine months ended September 30, 2012, our selling, general and administrative expenses increased by $5.8 million to $66.8 million as compared to $61 million for the comparable period in 2011. This increase was primarily attributable to legal costs that we incurred relating to our intellectual property litigation as well as to increased commissions payables to our hospital sales specialist as a result of increased revenue.

In addition, we accelerated the timing of a variety of marketing programs planned for 2012, which front loaded the expenses related to these programs to the first half of the year. As a consequence, our selling, general, administrative expenses were lower in the third quarter of 2012 and in the second quarter and we expect that SG&A expenses in the fourth will be similar to the third quarter. As of September 30, 2012, we have cash, cash equivalents and short-term investments of $74.5 million and net accounts receivable of $6.8 million.

I’ll now turn the call back over to Ted.

Theodore R. Schroeder

Thanks, Bill. The third quarter was our best commercial quarter to-date. We are seeing positive results from our sales efforts and we continue to receive enthusiastic feedback from physicians. We have a solid balance sheet with increasing revenues, and we look forward to building on OFIRMEV’s success. We are continuing to provide guidance for our net product revenue on a quarterly basis.

For the three months ending December 31, 2012, we expect that net product revenue from sales of OFIRMEV will be between $15.9 million and $16.4 million. This range includes the downside we expect to see from the disruption on elective surgical procedures in parts of the mid-Atlantic and northeast regions caused by Hurricane Sandy. I’d like to point out that our supply chain is completely in tact and there were no production issues or lost inventory as a result of the Hurricane.

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 the line of Eric Schmidt with Cowen & Co. Your line is open.

Eric Schmidt – Cowen & Co. LLC

Good afternoon and thanks for taking my questions. Ted, just on the guidance for Q4, it looks like you’re guiding to a slightly lower incremental revenue gain than you just saw in Q3, between $2 million, $2.5 million in Q4 versus the $2.8 million you just posted in the solid quarter? Is that all Hurricane Sandy impact, and can you quantify what that impact might be or what you expect it might be?

Theodore R. Schroeder

Well, it’s not all Hurricane Sandy impact. it’s looking at trend in surgical procedures as well, but there is definitely some impact particularly on elective surgical volume we expect. as we survey the area and survey the hospitals, it seems like even now, many of them are not even back to doing surgical procedure. So it’s really the ability of patients to get to the hospitals, and the ability of patients to move forward with their procedures. that’s probably of our total business somewhere in the 2% to 3% impact; let me ask Scott Byrd to comment more specifically.

Scott A. Byrd

Yeah. So, I guess, real quick as the other thing I would mention is that the Q3 over Q2 also included the benefit of the 6% price increase. so once you adjust for that, we are expecting included in the guidance, increased in unit volume, quarter-over-quarter, a little bit more than what we saw in Q3 over Q2. Now as Ted points out that also includes some downside impact from Hurricane Sandy. We obviously can’t fully and accurately predict what the full impact is going to be. we’ve got just in the areas of the country that we’re FEMA disaster areas that’s about 10% or 15% of our national business. so the effects of that haven’t certainly played out. we have begun to see some impact, but we’re just on the front-end of it.

So we could see a rebound coming out of that area depending upon how quickly the infrastructure and the systems get back up and running and people can get back to their normal lives. but I won’t be able to provide some more color on that as we get a little bit further along into the year, and see some of this in the rear view mirror.

Eric Schmidt – Cowen & Co. LLC

Okay. And then second question, do you think you can get to cash flow break-even on the current cash resources?

William R. LaRue

Yes.

Eric Schmidt – Cowen & Co. LLC

Okay, that’s easy. Third question, I didn’t hear anything about your manufacturing partner on this call, I guess that’s good news. I know, you’re not reliant on them anymore. but are there any updates that might impact you, anyway should form even any settlements?

Theodore R. Schroeder

Noting has changed with the manufacturing, they continue to investigate the root cause and until the root cause is identified, we won’t be able to initiate manufacturing at that facility. but it’s moving forward, and we’re hopeful that’s all figured out.

Eric Schmidt – Cowen & Co. LLC

Thank you.

Operator

Thank you. Our next question comes from the line of Richard Lau with Wedbush Securities. I’m sorry; our next question comes from the line of Michael Smith with Leerink Swann.

Michael W. Schmidt – Leerink Swann LLC

Hi, good evening. Just wondering on the IP lawsuits, that are now in more advanced stages and the trial is approaching next year, I was just wondering how would you think about reducing risk going into the trial while maximizing the value of the IP and the product, what’s your overall strategy on this topic?

Theodore R. Schroeder

I’m actually not exactly sure you’re asking Michael, are you asking what our legal strategy is or are you asking about our strategy with regard to settlement?

Michael W. Schmidt – Leerink Swann LLC

Right with regard to settlement, I mean on the second quarter call, I mean that was before the Markman hearing and now we have the Markman hearing pass us, and the other lawsuits were actually is doing the U.S. PTOs, I understand there was a hearing last week with these two factors combined, I was just wondering, how are you thinking is with regard to settlement or IP going forward?

Theodore R. Schroeder

Well, I think our position is that, we have extreme confidence in the strength of our intellectual property. We think that we would prevailed a trial, but we will make the right decision for shareholders based on an appropriate settlement. So we have something to announce on that, we will but we are certainly not opposed to a settlement, but our strategy is to move forward and to litigate this with an outstanding team of litigators as we move forward and as the process works out we may have updates, but nothing to update on this call.

Michael W. Schmidt – Leerink Swann LLC

Okay, great. And just wondering are you planning on giving 2013 guidance at some point later this year?

William R. LaRue

Typically what we do Michael from a guidance standpoint as we said that at the fourth quarter conference call, which is early the following year and so we are looking at that currently in terms of what our strategy will be and so in that February call we’ll actually discuss guidance for next year?

Michael W. Schmidt – Leerink Swann LLC

Okay, great, thanks a lot.

Operator

Thank you. Our next question comes from the line of Louise Chen with Guggenheim. Your line is open.

Louise Chen – Guggenheim Securities LLC

Hi, good afternoon. My first question is with respect to your business development, what are you seeing out there since you know a lot of other companies are also looking for acquisition targets, what is the valuations look like and are you seeing good strategic opportunities?

Theodore R. Schroeder

We’re seeing good strategic opportunities, I think as we’ve discussed before our business development appetitive actually falls into a range of potential transactions everything from a co-promotion, co-marketing agreements to product licensing to acquisition of products. So we have a variety of products in each of those categories where we’re advancing discussions, and there is some or more competitive than others, and I think that’s probably on the acquisitions in the licensing side, that’s probably a bit more competitive than the co-marketing type of arrangements would be, because I think folks tend to actually narrow down on their preferred partners fairly quickly in those scenarios.

so a lot to choose from doing diligence on a number of opportunities and working through the process to understand if it’s the right transaction for Cadence. And it’s really valuations are not different than they’ve been, I don’t necessarily see the valuations are going up, but I certainly don’t see them coming down anytime in the near future.

Louise Chen – Guggenheim Securities LLC

Okay. And then my second question was just a follow-up on the cash resources question someone had asked earlier. so not expecting this to happen, but if your revenues don’t come in, in line with your expectations for 2013, what kind of flexibility, do you have on the SG&A side. Is there any variable cost there?

Theodore R. Schroeder

Yeah, I think there are variable costs, and we’re committed to get the cash flow break-even with the cash we have available. so we will make the appropriate adjustments to the expense line, if we fall short on revenues, although like you said, we don’t expect that that’s going to be the case.

Louise Chen – Guggenheim Securities LLC

Okay. and then last question is, just on your R&D and gross margin, how should we think about that relative to the third quarter? What you had posted there?

Theodore R. Schroeder

Well, we have that in the pediatric trial and as we’ve previously stated that’s the trial that will cost kind of in the range of $5 million that would be over kind of 2.5 year period of time. so with the severance that we had in the third quarter, I would expect that R&D burn in the fourth quarter would be pretty comparable. and we expect to see improving gross margins with volumes. So I think you’ll see improvement on the gross margin and pretty much similar expenses, as we indicated in the fourth quarter.

Louise Chen – Guggenheim Securities LLC

Thank you.

Operator

Thank you. Our next question comes from the line of David Steinberg with Deutsche Bank. Your line is open.

David M. Steinberg – Deutsche Bank Securities, Inc.

Thank you. And thinking about the potential settlement down the road, have you actually clarified who is the first to file, is it Exela or Paddock in that way, we can better assess their individual track records in settling?

Theodore R. Schroeder

No. David, we have not clarified that, and that’s still a bit unclear who the first filer is.

David M. Steinberg – Deutsche Bank Securities, Inc.

Okay. And then you’ve had two questions about getting the cash break-even. so just to cut it a different way, so the last several quarters, you’ve averaged about close to $3 million internal revenues each quarter, and thinking about getting to break-even, are you expecting some sort of acceleration in scripts or should we think about similar type sequential gains going forward throughout next year?

Theodore R. Schroeder

Well, we haven’t provided guidance for next year, and looking at the historical trend, we’re confident about that trend in looking at ways to accelerate that trend. we do have some programs that could move that trend forward. So as we get more clarity as we go throughout the year, we’ll be prepared to and give sharper guidance on that as we get into the beginning of next year.

David M. Steinberg – Deutsche Bank Securities, Inc.

Ted, just a follow-up, could you clarify what some of those programs might be and why have you not instituted them so far?

Theodore R. Schroeder

Well, some of the programs are really as a result of getting a better understanding in what the market needs. some of them involve large costumers that have not made the move into OFIRMEV yet that we feel like we’re very close to getting that through the PMC committees and that will open up more customers with the potential to drive the business. We’re pretty well penetrated, but there are still some big customers that we’d like to have, and feel like we’re making a lot of progress.

I think the other programs that are working; it’s really an understanding of the need to get stocking at the point of care. and that’s something that we’ve talked about for a while. but I think what’s changing there is a better understanding at the account level of the pharmaco-economic impact of OFIRMEV. And recently there have been several drug reviews that have shown that in fact, others have decreased length of stay in the OFIRMEV population compared to standard of care or the opioid population. and it’s just taken a while to get those results through and understood at the hospital level, there are many more of those that are teed up to go, and are in the process of being completed. And those tend to have a real acceleration in an individual account.

So those are the kinds of things I’m talking about is really a better understanding that pharmaco-economic benefit that leaves to broader stocking in the hospital, and then the movement of some large systems that haven’t fully embraced OFIRMEV yet to put it into a preferred formulary position that they could move in the year forward.

David M. Steinberg – Deutsche Bank Securities, Inc.

Okay, thanks very much.

Theodore R. Schroeder

You bet.

Operator

Thank you. Our next question comes from the line of Ami Fadia with UBS.

Ami Fadia – UBS Securities LLC

Hi, good evening. I had two questions, firstly just a clarification from an earlier comment, could you clarify that you expect R&D and SG&A to be generally flat in the fourth quarter versus third quarter?

Theodore R. Schroeder

That is correct. yes, Ami.

Ami Fadia – UBS Securities LLC

So, fourth quarter R&D kind of will include, well, does the third quarter already reflect the spending on the pediatrics study. And then that’s what will continue into fourth quarter?

Theodore R. Schroeder

Yeah. We initiated the enrollment in the third quarter, some of the expenses associated with it. And so those expenses will increase into the fourth, but they’re offset by the severance expense associated with the departure of two of our non-clinically focused executives. So, there is kind of an offset there. So it'll be flat as I mentioned.

Ami Fadia – UBS Securities LLC

Got it, okay, got it. Now on the gross margin side, I had expected a slightly higher ramp in this quarter. So could you give us a sense on what or how I should expect that to trend up in the fourth quarter and I think down the line, we were modeling somewhere around the mid-60s range? And if you could give us a sense of when we could achieve that, and then also if you could give us a sense of your current outlook on the peak sales number for OFIRMEV. And if not that, if you could give us a sense of where you think OFIRMEV could be maybe three to five years out? that would be helpful. Thanks.

Theodore R. Schroeder

Yes, so that the peak sales we haven’t guided to specific peak sales. but I do think as you look at the consensus around the various analysts, that’s a good indication. if we look toward Europe and the penetration they achieved in the number of vials that were sold there that gives you an indication of something in the $300 million to $500 million range, kind of just, if you get kind of half of what they got. So there is clearly upside beyond that. So, I think that the peak sales were still getting clarity on that. but I think in general, the analyst consensus is a good place to look.

William R. LaRue

Ami, in terms of margins, yeah, we’re volume depended, and we’re starting to see increases, we had a nice comparison year-over-year and quarter-over-quarter. We still are burdened by some idle facility costs that we have with our production equipment in Cleveland Mississippi at the Baxter facility. So that is a drag and as we work through that, we’ll have some margin pickup there. And then with volume, yeah, we expect as we move into 2013 to see a nice increase in terms of those margins.

Ami Fadia – UBS Securities LLC

All right, thank you.

Operator

(Operator Instructions) Our next question comes from the line of Greg Fraser with Bank of America. Your line is open.

Greg D. Fraser – Bank of America Securities/Merrill Lynch

Thanks, good afternoon guys. What was the average net sales price for OFIRMEV in 3Q and what are you anticipating for the ASP in 4Q?

William R. LaRue

Net selling price was in that $10.30-ish range is what we would anticipate in the fourth quarter, it was slightly below that in the third quarter, but it’s basically in that kind of 9% to 10% discount half of our WAC, which is the $11.40.

Greg D. Fraser – Bank of America Securities/Merrill Lynch

Okay. And just a bigger picture question there, are you anticipating more of a slow steady build in OFIRMEV demand over time or do you think that you’ll reach some sort of critical masses at some point of formulary access, physician experience et cetera, after which demand will really start to pick up?

Theodore R. Schroeder

I think, we get asked that question a lot. and I do think on any individual account, you do see demand hit a point of critical mass and then an acceleration. I think there’s a lot of factors that work against that, clearly as you move up in the hierarchy of use in the hospitals, you get more and more scrutiny on that utilization. and so let’s say, reps need to continue to work to get ahead of that. So I do think you’ve seen acceleration on individual account basis, it’s harder to see that acceleration kind hitting a particular point where you see a hockey stick type of growth, because you have so many accounts around the country that it kind of washes out those differences. But I do think an individual territories and individual accounts we see that. So I don’t expect to see quarter-to-quarter dramatic bend in the curve, but I do expect to see the sales will continue to grow in a robust way for a long time.

Greg D. Fraser – Bank of America Securities/Merrill Lynch

Okay, that’s helpful. And then finally on the generic challenges, can you say whether you have already engaged in settlement discussions with other at the filers? Thank you.

Theodore R. Schroeder

We’re not going to say that.

Operator

At this time, there are no further questions. So I will turn the call back to Mr. Schroeder.

Theodore R. Schroeder

Well, thank you everyone. I appreciate your questions and your interest. I appreciate you joining the call today, and we look forward to providing updates on our commercial progress in the months to come. Have a good afternoon.

Operator

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

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