Salix Pharmaceuticals, Ltd. Q4 2008 Earnings Call Transcript

| About: Salix Pharmaceuticals, (SLXP)

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP)

Q4 2008 Earnings Call Transcript

March 10, 2009 5:00 pm ET


Michael Freeman – Associate Vice President of Investor Relations and Corporate Communications

Carolyn Logan – President and Chief Executive Officer

Adam Derbyshire – Chief Financial Officer

Bill Forbes – Vice President of Research and Development


Michael Tong – Wachovia Capital

Scott Hirsch – Credit Suisse


Welcome to the Salix Pharmaceuticals fourth quarter 2008 earnings release conference call. Today's conference is being recorded. At this time, I'd like to turn things over to Mr. Michael Freeman, Associate Vice President of Investor Relations and Corporate Communications.

Michael Freeman

Thank you. Good afternoon. Thank you for joining us today. I am Mike Freeman, Associate Vice President of Investor Relations and Corporate Communications for Salix Pharmaceuticals. With me today are Carolyn Logan, our President and Chief Executive Officer, and Adam Derbyshire, our Senior Vice President and Chief Financial Officer.

Adam will begin the presentation with a review of the financial results for the fourth quarter and full year 2008. Carolyn then will review operations to complete the foremost segment of today's call. At the conclusion of these comments, management will respond to appropriate questions.

Various remarks that management might make during this conference call about future expectations, plans, and prospects for the company constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results might differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our press releases and SEC filings, including our Form 10-K for 2007. Specifically, the information in this conference call related to projections, development plans, and other forward-looking statements is subject to this Safe Harbor.

I now will turn the call over to Adam Derbyshire, our Chief Financial Officer.

Adam Derbyshire

Total product revenue was $60.6 million for the fourth quarter of 2008 compared to $39.1 million for the fourth quarter of 2007. Total product revenue for the full year of 2008 was $178.8 million compared to $232.9 million for the full year of 2007. The decrease in total product revenue for the full year was due to the genericization of COLAZAL on December 28, 2007.

XIFAXAN revenue for the third quarter of 2008 was $23.8 million, a 40% increase compared to the fourth quarter of 2007. XIFAXAN revenue for the full year of 2008 was $79.9 million compared to $64.3 million for the full year of 2007, an increase of 24%.

MOVIPREP, OSMOPREP and VISICOL, which comprise of our bowel cleansing product line, generated revenue of $21.4 million for the fourth quarter of 2008, compared to $13.1 million for the fourth quarter of 2007, a 63% increase. Total product revenue for our bowel cleansing product line was $62.9 million for the full year of 2008 compared to $47.7 million for the full year of 2007, a 32% increase. Total product revenue for the fourth quarter and full year of 2008 includes the initial stocking of APRISO in the amount of $9.1 million.

Total cost of products sold was $14.6 million for the fourth quarter and $36.7 million for the full year of 2008. Gross margin on total product revenue was 75.9% for the fourth quarter of 2008 compared to 56.7% for the fourth quarter of 2007 and 79.5% for the full year 2008, compared to 76.4% for the full year of 2007. Lower gross margin in the fourth quarter and full year of 2007 is a result of the return reserve recorded in the fourth quarter of 2007 for COLAZAL due to the approval of three generic balsalazide capsule products.

Research and development expenses were $20.9 million for the fourth quarter of 2008 and $76.6 million for the full year 2008, compared to $15.1 million and $71.9 million, respectively, for the prior year periods. Selling, general, and administrative expenses were $27.5 million for the fourth quarter of 2008, compared to $22.4 million for the fourth quarter of 2007, and these expenses were $95.1 million and $86.5 million for the full year 2008 and 2007, respectively.

The company reported a net loss of $10.5 million, or $0.22 per share, fully diluted, for the fourth quarter of 2008, including a $5 million up-front payment to Napo Pharmaceuticals for the acquisition of crofelemer. The net loss for the full year 2008 was $47.0 million, or $0.98 per share, fully diluted, including the Napo payment. The loss of $0.98 per share for the year is in line with our previously stated guidance of a loss of approximately $1.00 per share, including the Napo payment. Excluding the Napo payment, the non-GAAP loss for the full year was $0.88 per share fully diluted. This non-GAAP loss of $0.88 is slightly ahead of analysts’ consensus of a loss of $0.91 and our previously stated guidance of a non-GAAP loss of $0.90.

In August 2008, the company closed a $60 million convertible note offering. This funding should facilitate our ability to finance development and licensing activities and acquisitions in a timely fashion. Cash and cash equivalents were $120.2 million on December 31, 2008.

We are extremely pleased with the continuing robust growth of XIFAXIN, our most compelling long term opportunity and our bowel cleansing franchise. Combined product revenue from XIFAXIN and our bowel-cleansing products achieved a year over year growth of 50% for the fourth quarter of 2008 and 28% for the full year. This strong fourth quarter growth was driven primarily by the outstanding performance of our bowel-cleansing products subsequent to the withdrawal from the market of a competitive over-the-counter product in mid December 2008. Market research suggests that the withdrawal of this competitive OTC product could expand the overall prescription market as much as $3 million uses or an additional $150 million. So we anticipate that our bowel cleaning franchise should grow significantly during 2009.

We continue to believe several factors should contribute to an increase in product revenue over the coming years, namely the continued growth of our currently marketed products including our most recent addition APRISO, the launch of our new product candidates currently undergoing FDA review if approved, the expanded contribution of Rifaximin if additional indications are approved, and further expansion of our product portfolio via development activities, licensing, and acquisitions.

We believe total company product revenue for 2009 will be $230 million to $235 million, not including revenue from METOXOLV orally disintegrating tablets or ODT, which is still under FDA review. This 2009 revenue guidance represents 30% growth over 2008 revenue. The current annualized run rates, based on dollarizing the latest prescription data for XIFAXAN, our bowel cleansing product line, and our other products excluding Apriso are approximately $100 million, $78 million, and $36 million respectively.

Salix is committed to building on its core business and leveraging its leadership position in gastroenterology to continue to create the leading U.S. specialty pharmaceutical company focused on gastrointestinal disorders. To that end, during 2008 the company invested $76.6 million, or 43% of revenue, in research and development efforts, including the completion of our Phase 3 trial of rifaximin for the treatment of hepatic encephalopathy or HE and initiation of Phase 3 trials of rifaximin for the treatment of non-constipation irritable bowel syndrome or non-C IBS.

During 2009 we intend to continue our research and development efforts, specifically the submission of a New Drug Application for rifaximin in HE, the completion of our Phase 3 trials of rifaximin in the treatment of non-C IBS and the ongoing development of budesonide and crofelemer. We anticipate that our investment in these projects and other research and development activities should require approximately $99 million, or 43% of the midpoint of revenue guidance for 2009.

During 2008, selling, general, and administrative expenses totaled $95.1 million, or 53% of revenue. Selling, general and administrative expense for 2009 should be approximately $111 million, or 48% of the midpoint of revenue guidance. We anticipate generating a loss of approximately $0.75 per share to $0.65 per share, fully diluted, for the year ending December 31, 2009.

Based on the full year 2009 guidance provided above, for the first quarter of 2009 we anticipate total company product revenue will be approximately $46 million to $47 million and will generate a loss of approximately $0.38 per share to $0.37 per share, fully diluted.

We continue working with the FDA to expedite the approval of METOZOLV ODT. We will update 2009 revenue and loss per share guidance if METOZOLV ODT is approved and launched to physicians. The update to 2009 revenue guidance will include the 2009 initial distribution and the 2009 prescription pull-through for METOZOLV ODT. The update to loss per share will include the change in revenue as well as expenses for launching METOZOLV ODT.

We anticipate that 2009 should be a year of unprecedented commercial activity and success for Salix. We continue to execute a commercial strategy to ensure that as our product portfolio expands, each of our products is given the attention and support required to achieve success. We have stated previously that we would approximately double our sales force upon the approval of rifaximin for non-C IBS. However, if METOZOLV ODT is approved in 2009, we have determined that we can better position the company to continue the launch of APRISO, launch METOZOLV ODT, and capitalize on the opportunity to expand our bowel cleansing business by accelerating a portion of our sales force expansion with the anticipated addition of 64 sales representatives.

We are in the very fortunate position of having more product offerings to present to physicians than we can optimally present during a single sales call. The planned expansion of our sales force during 2009 should allow our specialty sales representatives to communicate focused selling messages highlighting targeted products to a more strategically defined audience of physicians. Our strengthened position in the marketplace should translate into an increase in share of voice for all of our products and an increase in our ability to communicate more effectively to our targeted physicians and other healthcare professionals. We believe the benefit and potential of this expanded sales force should generate increased incremental revenue during 2009, as well as over the long term, and should substantially outweigh the costs associated with this next step required to grow the company’s sales capability.

I now will turn the call over to Carolyn Logan, our President and Chief Executive Officer.

Carolyn Logan

2008 was another productive year for Salix as we continued to move forward on many fronts, including the growth of our proprietary products. Prescription demand for XIFAXAN grew 10% and 9%, respectively, for the fourth quarter and full year of 2008 compared to the corresponding periods of 2007. Prescription demand for our bowel cleansing products grew 17% and 16% respectively, for the fourth quarter and full year 2008 compared to the corresponding periods of 2007.

XIFAXAN sales continued to increase during the fourth quarter of 2008. December was a record month both in terms of number of prescriptions and tablets with more than 38,400 prescriptions being written totaling almost 2 million tablets. Currently XIFAXAN is approved and marketed for the treatment of travelers’ diarrhea. We are committed to maximizing the commercial potential of this non-absorbed, gut-selective antibiotic and to that end we are working diligently to expedite the development of XIFAXAN for the treatment of hepatic encephalopathy and non-constipation irritable bowel syndrome. XIFAXAN was approved in the United States for travelers’ diarrhea in May 2004 and also has been used for approximately 23 years in a variety of indications in over 25 countries. We look forward to expanding the reach of this nonsystemic antibiotic in the United States market potentially beyond the treatment of travelers’ diarrhea to bring relief to patients suffering from other bacterial complications of the gut.

The bowel cleansing market is proving to be a dynamic and growing opportunity for Salix. As we expected, our ability to provide both a tablet agent, OSMOPREP, and a two-liter polyethylene glycol or PEG agent with ascorbic acid, MOVIPREP, creates distinct advantages in the marketplace and has provided an unprecedented opportunity for Salix to establish a leadership position. At the end of 2008, our products commanded a 25% share of the prescription market.

The prescription bowel cleansing market has experienced 17% compounded annual growth in terms of prescriptions over the past five years. During 2008 we estimate that approximately 12-13 million bowel cleansing procedures were conducted in the United States. According to our estimates, approximately 50% of these procedures utilized a prescription bowel cleansing product and approximately 50% utilized an over-the-counter product. The prescription market should experience significant additional expansion during 2009 as a result of the removal of the leading non-prescription or OTC bowel cleansing product from the marketplace in December 2008. We anticipate that the removal of the leading non-prescription product could expand the prescription market by as many as 3 million uses, or an additional $150 million.

I am pleased to report that for the first two months of 2009, our MOVIPREP business increased more than 80% in terms of prescriptions compared to the first two months of 2008. Our sales force is focused on capitalizing on the current market dynamic with the goal of significantly expanding our business in this growing market.

Additionally, our sales force began promoting APRISO during the last week of February and is focused on introducing this new solution for the management of ulcerative colitis. APRISO is the first and only once-daily 5-ASA or mesalamine product to offer both once-a-day dosing for the indication of maintenance of remission as well as being the only product to offer combination delivery in the form of delayed and extended release for the successful management of ulcerative colitis.

APRISO is the only pH-dependent, delayed release 5-ASA product that initiates the release of the active ingredient at a pH of 6. This is an important distinction in the marketplace. Competitive pH-dependent products initiate the release of their active ingredient at a pH of 7, and research indicates a pH of 6 is frequently achieved in the GI tract with approximately 90% of subjects achieving a pH of 6. Comparatively, a pH of 7 is less readily achieved in the GI tract, with approximately 25% of subjects never reaching a pH of 7. Consequently, APRISO’s delayed-release technology may offer a more reliable delivery of mesalamine throughout the colon. The extended-release profile of APRISO offers 24-hour protection from flares. APRISO’s extended-release technology facilitates mesalamine release over a sustained time frame and delivers the active ingredient throughout the entire colon. We believe APRISO’s ability to provide extended release of 5-ASA may provide patients with extended relief.

Two exciting and significant product development achievements for the year were the completion of our pivotal Phase 3 trial to evaluate the efficacy, safety, and tolerability of rifaximin in preventing recurrent, overt hepatic encephalopathy, or HE, and the initiation of enrollment in our two pivotal Phase 3 trials to evaluate the efficacy, safety and tolerability of rifaximin in the treatment of non-constipation irritable bowel syndrome, or non-C IBS as we refer to it.

In October 2008, we announced that the hepatic encephalopathy study demonstrated that a 6-month course of rifaximin dosed at 550 mg twice daily provides a highly statistically significant result in preventing HE, compared to placebo. In December 2008, our development team met with the FDA to discuss how to proceed with preparing and submitting a New Drug Application. Based on feedback provided by the FDA, the company agreed to continue the open label arm of the study in order to obtain additional 6- and 12-month safety data on study subjects.

Based on current timelines, we are targeting to submit the hepatic encephalopathy NDA during the second quarter of 2009. Rifaximin has been granted orphan drug designation by the United States Food and Drug Administration for use in hepatic encephalopathy. We believe that this designation will provide seven years of marketing exclusivity in the United States if rifaximin gains approval from the FDA for HE.

On June 30, 2008, we initiated enrollment in TARGET 1 and TARGET 2, our two 600-subject trials to assess the efficacy, safety, and tolerability of rifaximin 550 mg dosed three times daily in the treatment of subjects with non-constipation irritable bowel syndrome. Enrollment has progressed ahead of schedule in the approximately 190 sites across the United States. We originally had targeted completion of enrollment by the end of 2009; however, based on the accelerated rate of enrollment, we now anticipate completing enrollment by June 30, 2009. Currently, we expect top-line data on the trial should be available during the fourth quarter of 2009, and we are targeting to submit the non-C IBS NDA during the first half of 2010.

Support for the utilization of rifaximin in its currently-approved indication, travelers’ diarrhea, continues to increase. During the second quarter of 2008 the United Nations Medical Services Department revised their international travel guidelines to include XIFAXAN and began including XIFAXAN in travel kits dispensed by this organization.

In addition, recognition of the potential use of rifaximin in the treatment of hepatic encephalopathy and non-C IBS also continues to increase. The American College of Gastroenterology published treatment guidelines for IBS in the January 2009 American Journal of Gastroenterology which include a recommendation for the use of antibiotics, notably the non-absorbed agent rifaximin. The Annual Meeting of the European Association for the Study of the Liver or EASL, being held April 22-26, 2009 and Digestive Disease Week or DDW, being held May 30-June 4, 2009 should serve as high-profile venues for the release of the results of our pivotal Phase 3 study of rifaximin in the prevention of hepatic encephalopathy.

We are extremely pleased to announce that Dr. Nathan Bass, Professor of Medicine, Medical Director, Liver Transplantation Program, University of California San Francisco Medical Center, one of the investigators in the study, will make an oral presentation of the results of the hepatic encephalopathy study at EASL. Additionally, three posters providing data on the study will be presented by other investigators.

Then, at DDW, Dr. Guy Neff, Medical Director, Associate Professor of Clinical Medicine, Medical Director of Transplant at the University of Cincinnati College of Medicine, and Dr. Samuel Sigal from Cornell where he is assistant professor, Department of Medicine, both lead investigators in the study, will make oral presentations of the results of the study. Additionally, numerous posters will be presented at DDW providing data on studies with various Salix products and indications including the use of APRISO in ulcerative colitis and the use of rifaximin in IBS. We look forward with great anticipation to the release of these data.

The irritable bowel syndrome and hepatic encephalopathy indications present significant potential for the future growth of Salix. Currently, we estimate the aggregate commercial opportunity represented by these markets combined is approximately $2.8 billion.

Our business development activities continued in 2008, as evidenced by our acquisitions of a family of budesonide products and crofelemer. In March, we acquired a budesonide rectal foam and a budesonide gastro-resistant capsule from Dr. Falk Pharma. Dr. Falk markets these products in Europe, and we intend to develop these products for commercialization in the United States. Currently, there is no budesonide foam product available in the approximately $200 million rectal ulcerative colitis market in the United States. Efforts are underway to initiate late-stage clinical development of our budesonide foam product candidate during mid 2009.

In December 2008, we acquired crofelemer from Napo Pharmaceuticals. Currently crofelemer is being investigated in a Phase 3 study as an anti-secretory, anti-diarrheal agent for the treatment of chronic diarrhea in people living with HIV, or HIV-associated diarrhea. We expect to complete the Phase 3 study and submit an NDA to the FDA during 2010.

In addition, we consider intellectual property protection as an essential component of our product life cycle management strategy. In November, we announced that the United States Patent and Trademark Office issued a potential Orange Book patent relating to rifaximin for treating IBS caused by small bacterial overgrowth. This use patent provides protection until August 2019. Also during the year, we reported that we had received a notice of Paragraph IV Certification on behalf of Novel Laboratories advising of the submission of Abbreviated New Drug Applications for OSMOPREP and MOVIPREP. Salix has full confidence in the intellectual property rights that protect these products and intends to use all commercially reasonable means to continue to vigorously defend and enforce the intellectual property rights protecting its products.

The FDA issued complete response letters regarding the balsalazide tablet and METOZOLV ODT New Drug Applications on December 29, 2008, and February 26, 2009, respectively. With regard to the balsalazide tablet NDA, we have a Type A meeting scheduled with the Division of Gastroenterology Products to discuss the agency’s response. W hope that the issues raised by the agency can be resolved and the product can be approved for marketing.

With regard to the METOZOLV ODT NDA, I am pleased to announce that earlier today, a complete response including the newly-required Risk Evaluation and Mitigation Strategy, also referred to as REMS, the agency requested on February 26, 2009, was submitted to the FDA. This rapid response by the company again demonstrates the commitment and dedication of our development team, and I would like to take this opportunity to recognize their efforts and thank them for their efforts to expedite the approval of METOZOLV ODT.

We look forward to continued growth and expansion during 2009 and beyond. We plan to continue to execute our business strategy by in-licensing late-stage and marketed products, developing the products in our pipeline, and ensuring that our marketed products are provided with the attention and support required to achieve success.

This completes my comments. Thank you for your participation in today's call, and now I will learn the call over to the operator to begin the question-and-answer session.

Question-and-Answer Session


(Operator instructions). We will go first to Michael Tong with Wachovia Capital.

Michael Tong – Wachovia Capital

Adam, just a couple of P&L questions. I noticed the gross margin in the fourth quarter was a little bit below where the company was trending in the previous quarters. Can you comment on that, and is that the level that that we can expect going forward?

Adam Derbyshire

No, we would expect it to go back up to where it was before. What happened in the fourth quarters, we did have a slight write-down related to COLAZAL that went through COGS that brought gross margins down, and that was actually related to us continuing to do mail order business and having to adjust our price to keep the mail order business, so that was the charge that went through COGS in the fourth quarter.

Michael Tong – Wachovia Capital

Is it something that you can quantify? Excluding that charge, what would gross margin have been?

Adam Derbyshire

The charge was roughly $1.2 million.

Michael Tong – Wachovia Capital

With your respect to your R&D and SG&A guidance for ’09, how should we think about quarterly progression in terms of both line items?

Adam Derbyshire

It’s going to be spread pretty evenly throughout the year. There might be a little heavier in the front part of the year on R&D. SG&A, I would say again is pretty smooth, although you know around DDW and ACG, we have small spikes and then obviously once METOZOLV gets approved and launched, there will be some dollars related to that, and once we get more visibility on that, we’ll update our guidance obviously.

Michael Tong – Wachovia Capital

As it relates to XIFAXAN and OSMOPREP and MOVIPREP, what kind of net pricing should be assuming in our model?

Adam Derbyshire

For 2009?

Michael Tong – Wachovia Capital


Adam Derbyshire

Well, for XIFAXAN we are typically doing mid single-digit price increases, so you can expect that in 2009. The same with our bowel cleansing products, and then the other products, 10 to be double digit price increases, 10% to 15% on an annual basis.


Your next question comes from the line of Scott Hirsch with Credit Suisse.

Scott Hirsch – Credit Suisse

Where was the Napo $5 million charge? Was that in SG&A?

Adam Derbyshire

No. That’s actually under the license fees and costs related to collaborative agreements.

Scott Hirsch – Credit Suisse

So the run rate for SG&A here could go forward. If not, it’s not less because of that charge?

Adam Derbyshire


Scott Hirsch – Credit Suisse

Can you give us some clue as to what the requirements for REMS were? You obviously turned around a response pretty quickly, so my sense is that they weren’t that prohibitive.

Carolyn Logan

We have our vice president of R&D and our chief development officer here, so we are going to let him respond. As many of you probably know, the REMS program is relatively new, and there are variations of it, and so I’ll turn this over to Bill.

Bill Forbes

Really the heart of this particular REMS, and as you probably know, no two REMS seem to be the same, but the heart of this REMS is really medication guide and medication guide only, so under FDAAA which was enacted last year, when the agency requires a medication guide, they have to also do the risk evaluation and mitigation strategy along with it, and so turning the medication guide around and making the changes in the label was something that we could do very quickly.

Scott Hirsch – Credit Suisse

So it was just changing the label? You don’t have to set up any patient registries or anything like that?

Bill Forbes

No. No patient registries.

Scott Hirsch – Credit Suisse

I know you mentioned the stocking on APRISO. Do you have any indication or early indication of demand or anything like that?

Bill Forbes

No. As Carolyn stated, our representatives started calling all physicians the last week in February, so we just have a very early preliminary data at this point.

Carolyn Logan

The anecdotal feedback from sales has been very positive, and we’ve even had some feedback from one patient that was also a big success story, but it really is just, I think, a little soon to make any broad sweeping comments on that.

Scott Hirsch – Credit Suisse

Early signs are good, but no real comparative?

Carolyn Logan

Well, no. I guess the only comparative could be our first full week of data versus their full week of data. As best our data tells us, we were about the same.


(Operator Instructions). Your next question comes from the line of Michael Tong with Wachovia Capital.

Michael Tong – Wachovia Capital

Just a couple a quick ones on the EPS guidance, Adam. With respect to your EPS guidance, does that include or exclude the the new convertible accounting treatment?

Adam Derbyshire

It includes that.

Michael Tong – Wachovia Capital

As far as your SG&A and EPS guidance, how much of the sales force expansion or potential sales force expansion have you built in?

Adam Derbyshire

The guidance we provided on this call did not include any expansion, didn’t include any revenue associated with METOZOLV ODT nor did it include any expansion, and once METOZOLV ODT is approved and launched to physicians, we will update both revenue and EPS guidance when that happens.


This does conclude today’s question-and-answer portion of today’s call. At this time, I’ll turn it back over to Carolyn Logan for additional or closing remarks.

Carolyn Logan

I’d like to thank our stockholders, our employees, and other supporters for their continued confidence, and I look forward to speaking with you in the future.

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