Cadence Pharmaceuticals, Incorporated Q4 2007 Earnings Call Transcript

Apr.17.08 | About: Mallinckrodt PLC (MNK)

Cadence Pharmaceuticals, Inc (CADX) Q4 2007 Earnings Call March 12, 2008 4:30 PM ET

Executives

Cam L. Garner - Chairman of the Board Officer

Theodore R. Schroeder - President, Chief Executive Officer, Director

William R. LaRue - Chief Financial Officer, Senior Vice President, Treasurer, Secretary

James B. Breitmeyer M.D., Ph.D. - Executive Vice President - Development and Chief Medical Officer

Hazel M. Aker - Senior Vice President, General Counsel, Corporate Secretary

William S. Craig Ph.D. - Senior Vice President - Pharmaceutical Development and Manufacturing

Mike A. Royal M.D. - Vice President - Clinical Development, Analgesics

Catherine J. Hardalo M.D. - Vice President - Clinical Development

Malvina Laudicina - Vice President - Regulatory Affairs and Quality Assurance Officer

David A. Socks - Vice President - Business Development

Analysts

Adam Cutler - Canaccord Adams

Charles Duncan - JMP Securities

Gregory Fraser - Merrill Lynch

Manoj Garg - American Technology Research

Leland Gershell - Cowen & Company

Angela Larson - Susquehanna Financial Group

David Steinberg - Deutsche Bank Securities

Operator

Good day everyone and welcome to the Cadence Pharmaceuticals fourth quarter and full year 2007 financial results conference call. (Operator Instructions). At this time I would like to turn the call over to Mr. Bill LaRue, Senior Vice President and Chief Financial Officer. Please go ahead, sir.

William R. LaRue

Thank you. Good afternoon everyone and thank you for joining us today to discuss our fourth quarter and full-year 2007 financial results and ongoing clinical programs. On the call with me today are Ted Schroeder, our President and CEO; and Dr. Jim Breitmeyer, our Executive Vice President and Chief Medical Officer.

Before we get started, I would like to remind everyone that statements included in this conference call that are not a description of historical facts are forward-looking statements. These include statements regarding: the timeframes in which we expect to complete enrollment and announced results of our clinical trials; the timeframes for receiving feedback from the FDA regarding our development program for Acetavance and for filing regulatory submissions for our product candidates; our expectations for the market potential of our product candidates; our projected operating expenses and cash balances; and the adequacy of our funding to advance our development programs through NDA submissions.

The inclusion of forward-looking statements should not be regarded as a representation that any of our plans will be achieved. Our actual results may differ materially from those discussed in this call due to the risks and uncertainties inherent in our business, which include, but are not limited to, the following: we are dependent on the success of our only two product candidates, which may not receive regulatory approval or become successfully commercialized; additional clinical trials may produce results that are negative inconclusive or inconsistent with previously conducted trials; we may experience delays or problems in completing our clinical trials and other product development activities; we may be required to expand or modify our clinical trials or to conduct additional clinical trials, which could result in increased costs and delays and limit our ability to obtain regulatory approval; unexpected adverse side effects or inadequate therapeutic efficacy of our product candidates could delay or prevent regulatory approval or commercialization, or result in recalls or product liability claims; the market potential for our product candidates may be less than anticipated and we may be unable to successfully compete in our target markets; we will need to obtain substantial additional funding to complete our product development plans and may not be able to raise sufficient capital when needed; other risks that are detailed in our previous press releases as well as in our periodic public filings with the Securities and Exchange Commission.

All forward-looking statements are qualified in their entirely by this cautionary statement and we undertake no obligation to revise or update the information presented today. This caution is made under the Section 21E of the Private Securities Litigation Reform Act of 1995.

If anyone has not seen a 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.

I’ll now turn the call over to Ted.

Theodore R. Schroeder

Thank you, Bill, and thanks to all of you for joining us this afternoon. On today’s call, we will review our financial results for the fourth quarter and year ended December 2007, and provide an overview of our ongoing clinical development programs for Acetavance and Omigard. Following the financial and clinical overviews, we will open the call to your questions.

In 2007, we continued to advance the clinical development programs for our two hospital-focused product candidates: Acetavance, an intravenous formulation of acetaminophen for the treatment of acute pain and fever; and Omigard, antimicrobial gel for the prevention of catheter-related infections. We believe that these two product candidates will be well positioned to address unmet medical needs of hospital-based physicians in the areas of pain management and the prevention of infections. Our continued confidence in Acetavance is supported by successful post-operative pain trials of intravenous acetaminophen conducted by our licensor BMS and the product’s strong position as the market-leading injectable analgesic in Europe where approximately 300 million doses have been sold since the product was launched there in 2002.

Recent initiatives from the centers for Medicare and Medicaid services support our view that there is also significant unmet need from Omigard. As of October 2008, CMS will no longer reimburse hospitals for preventable hospital-acquired infections, including catheter-related infections, creating a compelling economic incentive for hospitals to use all available means to reduce their overall infection rates.

During 2007, we strengthened our management team with key senior-level appointments in the areas of clinical development, regulatory and legal affairs. In addition, in February 2008, we raised gross proceeds of approximately $49.3 million in a registered direct equity offering. With this infusion of capital and the strengthened management team, we believe we now have sufficient resources to advance our two product candidates through to NDA submissions. We currently anticipate filing new drug applications for both Acetavance and Omigard in the first half of 2009.

I’ll now turn the call back to Bill for an overview of our fourth quarter and full-year 2007 financial results, and outlook for 2008.

William R. LaRue

Thank you, Ted. For the fourth quarter ended December 31, 2007, we reported a net loss of 14.2 million or $0.50 per share, compared to a net loss of 9 million or $0.53 per share for the same period in 2006. For the year ended December 31, 2007, we reported a net loss of 51.7 million or $1.81 per share, compared to a net loss of 52.2 million or $10.07 per share for the same period in 2006. The full-year 2007 results also included approximately 4.3 million in stock-based compensation expense.

As of December 31, 2007, we held cash and cash equivalents of 55.4 million. Including proceeds from the registered direct offering completed in February 2008, our cash balance as of February 29, 2008 was 98 million. Total operating expenses for the fourth quarter of 2007 were 14.6 million, compared to 9.6 million for the same period of 2006.

The increase in operating expenses in Q4 of 2007 was primarily due to increased research and development costs of 2.1 million related to our ongoing clinical trials of Acetavance and Omigard and the addition of R&D staff to support clinical and regulatory efforts for both product candidates. In addition, general and administrative costs increased 1.2 million due to stock-based compensation expenses and other personnel related charges, professional and consulting fees and costs related to operating as a public company.

Total operating expenses for the year ended December 31, 2007 were 54.2 million, compared to 53.6 million for the same period in 2006. In 2007, R&D expenses decreased 6 million to 41.8 million, compared to 47.8 million in 2006. This decrease was primarily due to a 25.3 million initial license fee and related costs for Acetavance incurred in March 2006. Excluding this license fee, R&D expenses for 2007 increased 19.3 million from 2006 primarily due to the advancements of the Acetavance and Omigard clinical development programs.

Marketing expenses increased 2.1 million in 2007 to 2.9 million, primarily due to increased market research and related costs for Acetavance and Omigard, and increased salaries and related personnel costs from the planned addition of marketing staff in 2007 as compared to 2006. In addition, general and administrative expenses increased 4.6 million in 2007 to 9.6 million primarily due to increases in salaries and related personnel costs including a 1.5 million increase in stock-based compensation charges and from the planned addition of general and administrative staff in 2007 as compared to 2006 and costs related to operating as a public company. In terms of outlook for the remainder of 2008, we currently anticipate the total operating expenses for the full year 2008 will be between 54 and 59 million including an estimated of 4 to 6 million in non-cash stock-base compensation expenses. We also expect that our cash and cash equivalents at the end of 2008 will be between 41 and 46 million.

With that, I would like to turn the call over to our Executive Vice President and Chief Medical Officer, Dr. Jim Breitmeyer for a brief overview of our clinical development programs.

James B. Breitmeyer

Thank you, Bill and good afternoon everyone. We continue to focus our efforts on applying the knowledge we’ve gained from our recently completed clinical trials of Acetavance in order to strengthen our development program for this product candidate. Accordingly, shortly following our January 11, 2008 announcement of top-line data from Study 301, which was for the treatment of pain following abdominal gynecologic surgery and Study 302 which was for treating fever in adults, we initiated discussions with the FDA regarding our ongoing clinical program for Acetavance. The agency requested or responded with the request for a written briefing package in lieu of a meeting and we have since submitted the requested information.

We continue to expect to be able to provide any updates on our clinical development program that emerge from these communications by the end of the second quarter of 2008. As you know in the fourth quarter of 2007, we also initiated Study 304 which is a Phase III clinical trial of Acetavance for the treatment of moderate pain in adults following abdominal laparoscopic surgery.

Study 304 is a randomized double-blind, placebo controlled, multi-center study of 240 patients and it is designed to evaluate the safety and efficacy of two doses of Acetavance compared to placebo that is 1000 milligrams every six hours or 650 milligrams every four hours. Based on our recent learnings, we recently implemented several design modifications to Study 304 and this is also based on a thorough review of existing clinical literature and other pain trials as well as extensive input from our clinical development team as well as outside consultants.

The study modifications included tightening of the patient eligibility criteria such as allowing fever in more standardized types of laparoscopic surgery performing more frequent pain intensity assessments throughout the 24-hour study period and increasing control of opioid rescue medications during the trial.

We believe that these modifications further enhance the design of Study 304. We currently expect to complete patient enrollment in the third quarter of 2008 and to report top-line data from the study in the second half of 2008, assuming the successful completion of our clinical development program for Acetavance. We remain unscheduled to file an NDA for this product candidate in the first half of 2009.

I’ll turn briefly now to our development program for Omigard. We are very pleased with the rate of enrollment in our ongoing Phase III clinical trial for this product candidate and we are on track to reach our enrollment goal of 1850 patients in the second quarter of 2008. As previously stated, we also expect to report top-line data from the Omigard

trial in the second half of 2008 and if the trial is successful, we submit an NDA for this product candidate in the first half of 2009.

With that, I will now turn the call back to Ted for closing remarks.

Theodore R. Schroeder

Thanks Jim. In closing, I’d like to reiterate our commitment to advancing our clinical program for Acetavance. We continue to believe this product candidate can play an important role in the treatment of acute pain and fever in the hospital setting and we will focus our efforts on applying the knowledge we’ve gained from 301 and 302 studies as well as feedback from the FDA to strengthen our ongoing development program.

With that, I’d like to turn the call back to the operator and open the line for questions. Operator?

Question-and-Answer Session

Operator

Thank you sir. (Operator Instructions). We will take our first question today from Leland Gershell with Cowen & Company.

Leland Gershell - Cowen & Company

Hi good afternoon. Thanks for taking my question.

Theodore R. Schroeder

Sure Leland.

Leland Gershell - Cowen & Company

Hi, I want to first ask in event that we get back from the FDA that there will be another self tissue trial requirement, I want to know where you guys are you with plans there and what their view is on that design?

Theodore R. Schroeder

Sure. I think it would be – I’ll let Jim discuss that.

James B. Breitmeyer

Leland, we are looking at the totality of information available with Acetavance and with other non-opioid analgesic IV for optimal study designs. We think there is more than one possibility here and need to have some specific feedback from the FDA to assist us in getting to the final design, but the intention will be to pick a model that is the most extensively validated possible and to increase the probability of technical success in the study design. We do think that the laparoscopic design is a strong one and so an additional study might involve that or it might involve soft tissue surgery that’s a little bit more extensive than that.

Leland Gershell - Cowen & Company

Okay, great. And then, one more question if I may. On the laparoscopic surgery trial so, the two part question: one, with your modifications you made in terms of tightening the eligibility criteria and so forth, how far into the trial were those changes made in terms of enrollment and were those changes responsible for the push-up in enrollment goal to Q3 from Q2?

James B. Breitmeyer M.D., Ph.D.

Yeah. So to the second question, yes we let enrollments slowdown a little bit, while we were absorbing the results of Study 301 and contemplating some improvements to the study design. And it was relatively early in enrollment. We also don’t believe that the enhancement would mean that we have to replace patients that have been enrolled so far.

Leland Gershell - Cowen & Company

Okay, great. Thanks for taking the questions.

Theodore R. Schroeder

Thank you.

Operator

We will go next to Angela Larson with SFG.

Angela Larson - Susquehanna Financial Group

Good afternoon and thanks for taking questions today.

Theodore R. Schroeder

Sure, Angela.

Angela Larson - Susquehanna Financial Group

Could you talk a little about what breathing packages with the FDA and do you need to push to continue to get a meeting or what would be the acceptable timeframe for the FDA to give you comment on the breathing package?

Theodore R. Schroeder

Sure. Again, I think probably Jim is best equipped to handle that question, Angela.

Angela Larson - Susquehanna Financial Group

Okay.

James B. Breitmeyer M.D., Ph.D.

Thanks for the question, Angela. The one thing we understand is that the FDA is not taking a lot of Type-C meetings right now and this division is doing few, if any of these kinds of scientific advice meetings. And so, what we’ve -- we sent them some potential questions, they sent back communication that said, go ahead and submit your questions with the support of information in writing and so that’s what we’ve done. The briefing package is background information plus our questions in a form where we are requesting formal FDA response to the questions. And so we actually think in some ways that this is better than the meeting, one, we can -- we got our own package together earlier and had it in FDA’s hands compared to the briefing package we would have done for a meeting and two the dialog occurs in a written form, so we have a clear record of both parties thoughts. So putting that all together we think this is a good way to exchange our thoughts and have a record of the exchange.

Angela Larson - Susquehanna Financial Group

Okay, that’s very helpful and Bill maybe a question for you, if you could give us a little color on the change in long-term debt and what kind of interest expense we might associate with that?

William R. LaRue

Sure, the long-term debt increased as a result of a $15 million draw down in December of last year. In terms of interest rates, it’s a single digit kind of high-single digit rate nominal interest rate, it’s interest-only for the first six months and then amortization over the next 30 months.

Angela Larson - Susquehanna Financial Group

Okay, great thank you.

Operator

(Operator Instructions). We will go next to Adam Cutler with Canaccord Adams.

Adam Cutler - Canaccord Adams

Hi, thanks for taking the question. I am wondering, if you can process – is there still a possibility that the FDA will not require additional studies given that the 301 study while it failed to hit the primary endpoint did demonstrate that Acetavance was safe over 48 hours and given that you have the 304 study ongoing and now you’ve just initiated another multi-day safety study? Is it possible at least that those three dynamics could help satisfy the FDA requirements.

Theodore R. Schroeder

The short answer to that is yes. We do think that there is a possibility based on the approval of other 505(b)(2) products that have actually in the analgesics that have actually been approved for single pivotal trials. So, we think there is a strong rationale and the safety data are very clean over 48 hours as well as from other trials that have been completed around the world. And I think importantly the 48-hour PK data that shows no accumulation and Jim did you have any additional color you wanted to add to that.

James B. Breitmeyer

I agree with Ted, Adam, and we are pointing out to FDA that we have two completed pivotal studies of Acetavance, one in acute pain and one in fever.

Adam Cutler - Canaccord Adams

Okay. And then on the modification to the 304 study can you give us just a little bit more detail on what types of surgeries you had previously been including and that you are now excluding and then the changes sort of from and to sort of on the frequency of measurements and then just a little bit more about what you mean in terms of tighter opioid control?

James B. Breitmeyer

Sure, the clearest example on the surgical question is that we had previously permitted people who were having exploratory laparoscopy done but didn’t have any work done while they were in there. And so what we were doing is trying to have surgeries that have both a similar amount of incision produced and that we expect will have a similar profile for the visceral pain resulting from the work that’s done, so for example, laparoscopic hysterectomies, laparoscopic appendectomies, and laparoscopic cholecystectomies are all in the permitted group. As to the frequency of measurements we are now doing pain measurements every hour for the first 24 hours and then every two hours thereafter and pain measurements every time that patient’s -- I am sorry, every hour for the first twelve, and then every two for the rest, excuse me. And then the -- and a pain measurement anytime the rescue medication is given. And your third question was?

Adam Cutler - Canaccord Adams

Well, I guess, the last reference to opioid control?

James B. Breitmeyer

Yeah, so, we have asked that every patient go on a patient controlled analgesia with morphine or a single equivalent for people who are morphine allergic prior to the study and be over there -- their overnight rest from surgery until the end of the study. And then on study we are requiring that rescue medications be given as IV boluses so that patients aren’t put on a pump and left there so that each time that they need additional pain medications they can ask for it, but then we are sure to get a pain measurement at that time.

Adam Cutler - Canaccord Adams

Okay. Great, and then one last question if I may. Given that you expect to have the Omigard study fully enrolled in the second quarter why is it that it would take until the first half of ’09 to submit the NDA?

James B. Breitmeyer

So this is Jim again, I will answer that. It’s because there is relatively large amount of data that – a processing that has to be done after the last visit. So for example, we have a 30-day follow-up period for safety. He is a pretty sick patient and so we are making sure that we understand the long-term safety for these ICU patients. And then there is a lot of microbiology work that has to be done. The cultures have to be processed and genotyped and matched up. And then the primary endpoint goes through an independent evaluation committee. And so the three outside experts have to get together and adjudicate the primary endpoint.

Adam Cutler - Canaccord Adams

Okay. So is it fair to say that it will probably be pretty early in the first half of ‘09?

James B. Breitmeyer

Well, we haven’t guided anymore specifically than that at this point.

Adam Cutler - Canaccord Adams

Okay. Thanks a lot.

Operator

Your next question comes from David Steinberg with Deutsche Bank.

David Steinberg - Deutsche Bank Securities

Thanks. If I recall the gating item for the filing previously was the CMC section for Acetavance. I am just wondering given the modification in the soft tissue pain study whether the CMC would still be the gating item or whether the study itself would go on past that? And then, secondly, if for some reason the soft tissue pain study was unsuccessful would you -- you’d indicated you are going to file in the first half of ’09 does that imply that you would still go ahead and file just on the fever indication, get it out in the market and then take the clinical program from there?

Theodore R. Schroeder

Yeah, David let me comment on that. So the -- from the time line perspective as it relates to CMC that is still the gating item with the current program moving forward. If the FDA requests an additional study then the clinical program moves slightly forward on the critical path and becomes the gating item. So, the -- I guess a clear way to say that they are re almost neck-and-neck now but CMC as we sit today would still be the right limiting step with that to have adequate stability on the new manufacturer Baxter.

Regarding the fever indication, as you know, fever, if we file for fever as the primary -indication and keep in mind that would CMC restriction that wouldn’t be until the early part of ’09 anyway. Once we file for that indication we wouldn’t not be able to file a supplemental NDA until the original NDA is approved. So, you would be baking in a year delay at least for the acute pain indication. So the only scenario that and we’ve talked about this extensively that we believe that makes business sense would be it for some reason there is a delay beyond our expectations with the requirements from the FDA. I want to be clear that we think that is a very slim, outside chance that there would be anything that would put a year delay beyond the first quarter of ’09 into filing. So, we don’t see that as very likely, but should there have been anything like that – should something like that happen, then we would hold the option open to file the fever indication.

David Steinberg - Deutsche Bank Securities

Okay. And then just a quick follow-up, could you give us the latest data that you have on how Acetavance is doing in Europe with Bristol-Myers in terms of either dollars or units, what’s the most recent data you have? And then secondly in-licensing hospital-based products is part of your – is your strategy and could you update us on how the in-licensing pipeline looks and what the probabilities maybe that you would bring in a product or two during 2008?

Theodore R. Schroeder

Sure. So, the -- from a performance standpoint in Europe, for the full-year 2007 Bristol sold about 80 million doses of Acetavance in Europe, so that’s a bit more than $200 million in sales, so continues to grow robustly in Europe, which we think is a great model for the US. It’s really - continues to grow year-over-year. And keep in mind that this took them several years to get launched in all of the big markets. So, they took nearly three years to get the product available broadly in the biggest markets. So, we have high hopes for a rapid uptake. The other thing that I can tell you and it’s in our corporate presentation is that we recently completed some market research, kind of the standard market research where you are trying to segment the market and look at the early adopters through to the laggards.

In this research we have a fairly large study speaking to a broad group of physicians, anesthesiologists and different surgical specialties, 83% of the respondents said that they would begin using the product immediately upon approval. In the 21 years or so that I have been selling and marketing in the hospital space, I’ve never seen a product that had that kind of early enthusiasm for adoption. So to me, that’s a clear indication that physicians understand the role of acetaminophen, see a place forward in the marketplace, understand where it would fit and are anxious to have it available to give them more flexibility in managing patients’ pain.

On the business development front, we’ve had a robust pipeline of products. We, actually during 2007, actually had a look at almost 70 different opportunities, that’s 7-0 opportunities. We actually took more than a dozen of those in the diligence. We ultimately decided not to move forward with any of those programs, largely because strategically they didn’t seem to fit. Some of the more exciting programs were at either a little bit earlier stage or were in therapeutic categories where we felt the execution risk was higher, particularly on the regulatory front. And so, we thought at this stage of our development that didn’t make sense. Nonetheless, moving forward into 2008, we already have a robust pipeline of opportunities, later stage products that we are excited about. I’m not going to stick a stake in the ground and say we’ll do a transaction this year, because I don’t believe we need to do one. But I do think that we’ll be opportunistic and should we advance any of the programs we will and they make sense both strategically and clinically, we will go after them aggressively.

David Steinberg - Deutsche Bank Securities

Okay. Thank you.

Theodore R. Schroeder

You bet.

Operator

(Operator Instructions). And we do have a follow-up from Angela Larson with SFG.

Angela Larson - Susquehanna Financial Group

Thank you for taking the follow-up. I was just hoping you could give us a little color as you move forward on the SG&A. I know that it -- or just the sales and marketing. It stepped up significantly in the fourth quarter. And now that you are looking at filing products in the first half of ’09, how much more should we be looking for that to step up?

Theodore R. Schroeder

Sure Angela. In terms of kind of a ratio, we are -- in ’08 it’s about 75 percentish for research and development and 25% for SG&A. We would hope to maintain a reasonable ratio in terms of the G&A. It’s really the sales and marketing that will step up over time. So, I would expect to see those -- that combined category move up into the 35% category over the next few years. But really we won’t start that until we have product approval is when you really going to start to see the significant ramp. But I think you could model in the 35% for the two categories.

William R. LaRue

And so, for 2008 though, it’s I think fair to say that our marketing expenses will not continue to grow like we may actually pull those back a little bit compared to ’07. The ramp in – it wouldn’t be fair to take the ramp from the fourth quarter and run that out for ’08 because we -- with a delayed program, we’ve certainly recognized some of that’s premature.

Angela Larson - Susquehanna Financial Group

That’s helpful. Thank you.

Theodore R. Schroeder

You bet.

Operator

There appear to be no further questions. At this time, I’d like to turn the conference back over to Mr. Schroeder for any additional or closing comments.

Theodore R. Schroeder

Thank you. I appreciate everyone joining us today and for your questions and your interests, and we’ll look forward to interacting with you in the future. Thanks and have a good afternoon.

Operator

Ladies and gentlemen, this does conclude today’s conference call. All parties may disconnect.

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