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Salix Pharmaceuticals Ltd. (NASDAQ:SLXP)

Q3 2007 Earnings Call

November 6, 2007 5:00 pm ET

Executives

Michael Freeman - Executive Director of Investor Relations &Corporate Communications

Carolyn Logan - President and Chief Executive Officer

Analysts

Michael Tong - Wachovia Securities

Don Ellis - Thomas Weisel Partners

Angela Larson - SIG

Mitul Desai - Piper Jaffray

Robert Uhl - FBR

Greg Gust - Roth Capital Partners

Operator

Good day, everyone, and welcome to the Salix PharmaceuticalsThird Quarter 2007 Earnings Release Conference Call. Today's call is beingrecorded.

At this time I would like to turn the call over to Mr.Michael Freeman, Executive Director of Investor Relations and CorporateCommunications.

Mr. Freeman, please go ahead.

Michael Freeman

Thank you, and good afternoon. Thank you for joining ustoday. I am Mike Freeman, Executive Director of Investor Relations andCorporate Communications for Salix Pharmaceuticals.

With me today is, Carolyn Logan, our President and ChiefExecutive Officer. Carolyn will begin the presentation with a review of thefinancial results for the third quarter of 2007 and then will review operationsto complete the formal segment of today's call. At the conclusion of thesecomments management will respond to appropriate questions.

Various remarks that management might make during thisconference call about future expectations, plans and prospects for the Companyconstitute forward-looking statements for purposes of the Safe Harborprovisions under the Private Securities Litigation Reform Act of 1995.

Actual results might differ materially from those indicatedby these forward-looking statements as a result of various important factors,including those discussed in our press release and SEC filings, including ourForm 10-K for 2006.

The information in this conference call related toprojections, development plans and other forward-looking statements is subjectto this safe harbor.

I now will turn the call over to Carolyn Logan, Presidentand Chief Executive Officer.

Carolyn Logan

Thank you, Mike. Hello, everyone. Before starting today'scall I want to give you a brief update on Adam Derbyshire, our Senior VicePresident of Finance and Chief Financial Officer.

As many of you know, Adam was diagnosed with cancer back inthe summer. He has successfully completed the chemotherapy portion of histreatment, and on October 22 he underwent surgery to clean up and remove anyremaining tumor remnants.

Post surgery it is not uncommon for a few additional chemotreatments to be needed, and that's still being determined for Adam. All phasesof his treatment thus far have been very successful, and as soon as herecuperates from this recent surgery and follow-up he'll be back at work asgood as new.

Since Adam is out today, Tim Creech, our Executive Directorof Finance, will be joining Mike and me on this call and will be available forthe question-and-answer portion of the call. I'm sure each of you join all ofus here at Salix in wishing Adam a speedy recovery.

Total product revenue increased 32% year over year to $67.4million for the third quarter of 2007, compared to $51.2 million for the thirdquarter of 2006. Total product revenue for the first nine months of 2007 was$193.8 million, a year-over-year increase of 33%.

COLAZAL generated revenue of $31.1 million for the thirdquarter of 2007, compared to $27 million for the third quarter of 2006. COLAZALgenerated revenue of $92.4 million for the first nine months of 2007, comparedto $73.1 million for the first nine months of 2006.

XIFAXAN revenue for the third quarter of 2007 was $16.1million, compared to $15.9 million for the third quarter of 2006. XIFAXANrevenue for the first nine months of 2007 increased 44% compared to the firstnine months of 2006.

MOVIPREP, OSMOPREP and VISICOL, which comprise our bowelcleansing product line, generated revenue of $12.1 million for the thirdquarter of 2007, compared to $6.6 million for the third quarter of 2006.

Our bowel cleansing product line contributed $34.6 millionin product revenue for the first nine months of 2007, compared to $34 millionfor the first nine months of 2006. Our other products category generatedrevenue of $8 million and $19.6 million for the third quarter and first ninemonths of 2007, respectively; compared to $1.7 million and $6 million for thecorresponding periods of 2006.

The year-over-year increases in other products revenue forthe third quarter and first nine months of 2007 primarily reflect thecontribution of PEPCID OS, which we acquired in February 2007.

Currently, the annualized demand for COLAZAL is $115million, for XIFAXAN is $66 million and for our bowel cleansing products it's$60 million. Annualized demand is based upon an annualized run rate utilizingthe latest prescription data.

Total cost of products sold was $13.1 million for the thirdquarter and $38.1 million for the first nine months of 2007. Gross margin ontotal product revenue was 80.6% for the third quarter of 2007, compared to77.2% for the third quarter of 2006, and 80.3% for the first nine months of2007, compared to 80% for the first nine months of 2006.

Research and development expenses were $16 million for thethird quarter of 2007, compared to $10.3 million for the prior year period.Research and development expenses were $56.8 million for the first nine monthsof 2007, compared to $32.1 million for the prior year period.

Selling, general and administrative expenses were $20.9million for the third quarter of 2007 and $64.1 million for the first ninemonths of 2007, compared to $20.7 million and $63.5 million, respectively, forthe corresponding periods of 2006.

The Company reported net income of $14.2 million, or $0.29per share, fully diluted, for the third quarter of 2007, which representyear-over-year 102% and 93% increases, respectively, compared to third quarter2006 net income of $7 million and third quarter 2006 EPS of $0.15, fullydiluted.

For the first nine months of 2007 the Company reported netincome of $27.3 million, or $0.56 per share, fully diluted, which represent 55%and 51% increases, respectively, compared to first nine months of 2006 netincome of $17.6 million and first nine months of 2006 EPS of $0.37, fullydiluted.

Cash, cash equivalents and investments were $70.2 million onSeptember 30, 2007. As of October 31, 2007 cash, cash equivalents andinvestments were $118 million, including the collection of approximately $63million in accounts receivable.

Product revenue achieved $67.4 million for the third quarterof 2007, which is an all-time high level of performance for a quarter. The taxrate for third quarter 2007 was 13.4%. These factors combined to yield reportednet income of $14.2 million, or $0.29 per share, fully diluted, for the quarter.

We now believe that total product revenue for the entireyear 2007 will be approximately $262 million. We anticipate that the tax ratefor fourth quarter 2007 will be approximately 13% and the tax rate for the fullyear will be approximately 14%.

Additionally, we now expect R&D expenditures should beapproximately 26% of revenue and SG&A expenditures should be approximately33% to 34% of revenue for the entire year.

Taking these factors into consideration, based uponinformation currently available, we now believe that we will be able togenerate $0.88 in earnings per share, fully diluted, for the year endingDecember 31, 2007.

The projected 2007 EPS of $0.88 represents a 50% increase,on a tax-adjusted basis, compared to 2006 EPS of $0.65.

The Company continued to make advances during the thirdquarter in the commercialization of our existing products, the ongoingdevelopment of our product candidates and the acquisition of new products.

Our bowel cleansing products and XIFAXAN continue todemonstrate strong prescription growth trends. We reported last quarter thatduring April and May 2007 OSMOPREP and MOVIPREP respectively achieved recordlevels of prescriptions written during a single month.

I am pleased to report that OSMOPREP and MOVIPREP prescriptionswritten during August 2007 outpaced these previous record levels by 7% and 8%,respectively. Additionally, we previously reported that during May 2007 XIFAXANachieved a record high number of prescriptions written during a single month.XIFAXAN prescriptions written during August 2007 outpaced the May level by 3%.

COLAZAL prescriptions for the first nine months of 2007remained stable compared to the first nine months of 2006 commendableperformance in the highly competitive 5-ASA marketplace.

We also achieved several significant product developmentmilestones during the third quarter. On July 17th the Company submitted an NDAto the United States Food and Drug Administration seeking approval to market an1100 mg tablet formulation of balsalazide disodium designed to reduce pill anddosing burden by decreasing the number and frequency of doses needed to betaken by patients to obtain relief from their ulcerative colitis.

We completed the comparator-controlled, multi-center studyof balsalazide tablets during the period, and the trial achieved its primaryendpoint of non-inferiority. As planned, these results will be submitted to theFDA in conjunction with the four-month safety update later in November. Theapplication has been accepted for filing and is currently under review. Weanticipate receiving a response from the agency on this NDA by May 16th 2008.

In September, we announced the successful completion andoutcome of our 680-patient, multicenter Phase IIb trial to assess the efficacyand safety of rifaximin in the treatment of patients with diarrhea-associatedirritable bowel syndrome or dIBS. This 14-day course of rifaximin, dosed 550 mgtwice-a-day, provided statistically significant improvement in both adequaterelief of dIBS symptoms as well as adequate relief of the IBS-related bloating,compared to placebo.

These results provide a solid rationale and basis forfurther investigation in pursuit of marketing approval. An end-of-Phase IImeeting with the FDA has been scheduled for mid-December. We continue toanticipate initiating our Phase III trials of rifaximin in the treatment ofdIBS during the first quarter of 2008.

Also during the quarter we announced the successfulcompletion of two Phase III trials to assess the efficacy and safety of ourgranulated mesalamine for the maintenance of remission in ulcerative colitispatients.

In each of these multicenter trials a statisticallysignificantly greater portion of subjects treated once-a-day with 1.5 grams ofgranulated mesalamine remained relapse-free over six months of treatment thanpatients dosed with placebo. We currently anticipate submitting an NDA inDecember 2007 seeking to market granulated mesalamine for the maintenance ofremission of ulcerative colitis.

Granulated mesalamine is unique in that it combines anenteric pH-dependent coating, which provides for delayed release, and a polymermatrix core, which provides for extended release. The formulation is designedto provide for the distribution of the active ingredient beginning in the smallbowel and continuing throughout the colon.

Additionally, granulated mesalamine, if and when approved bythe FDA, will be the only pH-dependent product in its class that begins torelease at a pH of 6. We believe this novel, patent-protected granulatedformulation of mesalamine, if approved, should improve the convenience ofmaintenance therapy for ulcerative colitis patients and serve as an importantaddition to our 5-ASA product portfolio.

During the second half of October approximately 600 Eisaisales representatives began promoting COLAZAL as a result of our recentlyannounced balsalazide co-promotion agreement. We look forward to thecontributions their efforts should make in the near term to increase the shareof voice in the marketplace for COLAZAL, as well as in the longer term toexpedite the introduction and growth of our patent-protected balsalazide tabletproduct if approved.

We believe Eisai's primary care sales effort should captureadditional business that's available outside the scope of ourgastroenterologist-focused sales strategy. We expect this strategic agreementshould increase product revenue without incurring significant incrementalexpense.

In September, Salix acquired the exclusive, worldwide rightsto metoclopramide-Zydis. We are pleased to announce that today WilmingtonPharmaceuticals, the licensor, submitted an NDA for the product to the U.S.Food and Drug Administration.

Metoclopramide is indicated for short term therapy foradults with symptomatic, documented gastroesophageal reflux who failed torespond to conventional therapy, as well as for the relief of symptomsassociated with acute and recurrent diabetic gastric stasis.

The Zydis technology provides for a freeze dried oral soliddosage form of metoclopramide that disintegrates rapidly on the tongue and canbe taken without water. We look forward to the addition, if approved, of thispatent-protected, fast-dissolving formulation of metoclopramide to our productportfolio.

We believe that our specialized sales force is positioned toeffectively commercialize this patient-friendly formulation of this widelyprescribed agent. Additionally, in keeping with our strategy to focus on theU.S. market, during the third quarter we announced the licensing of OSMOPREPmarketing rights for France to Mayoly-Spindler.

We are extremely pleased with our accomplishments during thethird quarter of 2007, and we continue to build on our successes to expand andcommercialize our growing portfolio of innovative products to prevent or treatgastrointestinal disorders and to create exceptional value for ourstockholders. This completes my comments. Thank you for your participation intoday's call.

And now I would like to turn the call over to the operatorto begin the question-and-answer session. Thank you.

Question-and-Answer Session

Operator

(Operator Instructions) And we will take our first questionfrom Michael Tong with Wachovia Securities.

Michael Tong - Wachovia Securities

Hi. Good afternoon, Carolyn.

Carolyn Logan

Hi, Michael.

Michael Tong - Wachovia Securities

Just want to get a little bit better clarity on the, I guessthe moving around of the operating expenses. What did you see that caused theR&D to spike up relative to your previous expectations and at the same timethe SG&A to kind of come down a little bit?

Carolyn Logan

Well, they weren't huge swings. If you remember, we hadguided to 25% for R&D. But PDUFA expense went up by about $400,000. In thefiling of some of the NDAs we had to do a little additional PK work or someanalytical work that increased that a little bit.

And we were very committed to holding on our EPS commitment.So we were able to manage expenses pretty closely on some of the SG&A areasto bring those down or little less.

Michael Tong - Wachovia Securities

And just along the lines of SG&A, do you run the risk ofactually slowing prescription for XIFAXAN as well as your bowel cleansingfranchise? Because it looked like the last several weeks of prescription dataXIFAXAN has been trending just a little bit light?

Carolyn Logan

Well, as you know, with XIFAXAN we have been we've reallytaken a hard line on not being able to have any thoughts by any agency that wewere doing anything to promote the drug off label, which we have never done andnever intend to do.

So it has dropped to fourth in our bag, and we are notpaying bonus on the product at the current time. So with XIFAXAN, the salesforce still is talking about it for traveler's diarrhea. We still get questionsthat come in through Medical Affairs.

But there is not a high level of activity from our salesforce with XIFAXAN right now. Now, we are doing things through Medical Affairs,certainly answering all physician questions and sending data to them that hasbeen publicized and is appropriate to share.

We really don't think we had guided to around 35% onSG&A, so we've only trimmed that back slightly and we certainly wouldn't doanything that we thought would jeopardize prescriptions or growth.

Michael Tong - Wachovia Securities

Great. Thanks. And good to hear that Adam's doing well.

Carolyn Logan

Yes, we're very happy about his progress.

Operator

And our next question will come from Don Ellis with ThomasWeisel Partners.

Don Ellis - Thomas Weisel Partners

Thank you. Good afternoon.

Carolyn Logan

Hi, Don.

Don Ellis - Thomas Weisel Partners

Hi. A couple of questions about I'll ask them one at a time,starting with the Metoclopramide product, can you describe the intellectualproperty around that product and a little more about the market opportunity?

Carolyn Logan

I believe the intellectual property protection is to around2022. I think there may be some additional patents pending that would go out to2025. We haven't considered this to be not a several $100 million productopportunity, but we do think it's a nice addition we think our gastros willreally like this product. I think we're thinking that peak sales would possiblybe close to maybe $40 million or $50 million.

Don Ellis - Thomas Weisel Partners

Okay, great. And, next, on the co-promote, start withCOLAZAL in October with the sectional reps, can you tell us where this is? Isit position one and two, and are there a limited number, a specific number ofdetails that they have to accomplish in a month?

Carolyn Logan

The all of their sales representatives had completedtraining by the end of October. And they're very excited about the opportunityto promote COLAZAL. It is second in their bag. However, in the gastroenterologymarketplace, where they have had a proton pump inhibitor, that's the onlyproduct they've had to talk about for quite some time.

I think Eisai management as well as we believes willprobably going to get more attention than a second product detail wouldnormally get, and of course we're very happy about that.

So they're really just getting up and running, but thecommunication between both our companies has been great. Their excitement levelseems high. They have a strategic alliance manager as well as we, so there's alot of communication between the two organizations, and then that also goesdown to the field level.

Don Ellis - Thomas Weisel Partners

Okay. And last question is regarding your sales force, whereI mean, you told us where XIFAXAN is, I think you said that's number four,where is COLAZAL and OSMOPREP and MOVIPREP in your sales force's bag at thistime?

Carolyn Logan

COLAZAL is in the primary position because, as you know,Lialda has been in launch phase. And we have fought aggressively to protect ourbusiness there. And we're pretty pleased with what we've been able to do,because they've just recently gone to about a 7% market share in TRx.

And they got about 5% of that from Asacol, about 1% fromtheir own Pentasa and about 1% from us about 1.2% from us. So we think we'veheld them pretty well, and now with the addition of Eisai we expect to be ableto do an even better job of that. So COLAZAL is number one. OSMOPREP orMOVIPREP are number two or three, and then XIFAXAN.

Don Ellis - Thomas Weisel Partners

Thank you very much for taking the questions.

Carolyn Logan

Thanks.

Operator

And our next question will come from Angela Larson withSIG.

Angela Larson - SIG

Hi, Carolyn.

Carolyn Logan

Hi, Angela.

Angela Larson - SIG

I wanted to stay on granulated mesalamine for just a minute.I appreciate the detail you gave in your comments. Could you tell us a littlebit more about the number of pills a patient would be taking, and how manytimes a day, and how that compares to Lialda?

Carolyn Logan

With granulated mesalamine, they'll be taking four capsulesonce a day. With Lialda, I believe they're indicated at two to four once a day.

Angela Larson - SIG

Okay. And then as you look forward, and I'm definitely notgoing to tie you to any exact numbers here. But just conceptually, as you lookforward to launching the COLAZAL capsules and the granulated mesalamine, you'veaugmented the sales force support with the Eisai relationship, would you needto continue to expand the sales force?

Carolyn Logan

We don't have any plans to expand the sales force based onthe balsalazide tablet or granulated mesalamine approvals. As we get closer toan IBS indication, we had said that we've previously said that we would haveplans to expand our sales force at that point to some extent.

I mean, that as the great thing about our business model is whenwe talk about expanding our sales force, we aren't talking about having to add200 or 300 representatives. It would be a much smaller number.

And the other thing that could cause us to expand our salesforce would be if we acquired something that we thought we had greatopportunity or potential to grow into a meaningful product, and in most cases Ican't think of a situation that it wouldn't be a patent protected product.

Angela Larson - SIG

Great. Thank you very much for that.

Operator

We will now take a question from Mitul Desai with PiperJaffray.

Mitul Desai - Piper Jaffray

Hi. Thanks for taking the call. I just was wondering if youcould give us an update on the status of the study of XIFAXAN for theprevention of traveler's diarrhea. I believe there's a second Phase III thatit's undergoing. I was just wondering when we can expect to see some of thatdata.

Carolyn Logan

That study has completed, but it has dropped in priority forus because we were very intent on getting our balsalazide tablet filed thisyear as well as the comparator trial to that NDA as well as the four-monthsafety update.

And the comparator and safety update will be filed inNovember. We also were intent upon finishing the two Phase III granulatedmesalamine trials and getting that NDA filed by the end of this year, and ourdevelopment group is on track to do that, to get that filing in December.

And then of course we've put a lot of resources towardsgetting our large Phase IIb IBS study enrolled and completed and getting thedata crunched and requesting a meeting with the FDA for that. So, thetraveler's diarrhea prophylaxis trial, from a commercial opportunity, just hasto take a back seat to all of that.

Mitul Desai - Piper Jaffray

Okay. So it was just a more a matter of allocation ofresources and not necessarily the results of the trial, or…

Carolyn Logan

Right. The study has completed, but I don't believe all thedata has been analyzed. I have not seen top line data on it yet.

Mitul Desai - Piper Jaffray

Okay. Thanks.

Operator

Our next question comes from Robert Uhl with FBR.

Robert Uhl - FBR

Oh, thank you. Just in looking out ahead, you know, you'vesaid in the past R&D next year should be 25% and SG&A 35%. Is thatstill good, or should we alter that really to reflect more of the change you'reshowing now in the second half of this year?

Carolyn Logan

I would say stick with what we have previously said for nextyear. We will be giving guidance on our fourth quarter or year-end call.That'll be in February. So if there's any need to fine-tune anything we willgive you guidance at that time, but for right now I would just stick with that.

Robert Uhl - FBR

Okay. And then just one other thing, like for example whenyou're giving this estimated demand of COLAZAL, I think for the three quartersof the year it's declined sequentially, but yet your reported sales go up orstay flattish, and the quarterly sales numbers reflect annual run rates thatare higher than your demand estimates so, why do you think that is?

Carolyn Logan

Well, actually, for the first nine-months of '07 compared tothe first nine months of '06, we're flat in prescriptions, the same number ofprescriptions. And then as far as this recent quarter, if you dollarized ourprescriptions it's right on with what we shipped. So our inventory levelremains in that eight to ten -weeks really for all our products.

If you dollarized our scripts for COLAZAL and XIFAXAN, it'salmost identical to what we shipped. Bowel cleansing, the dollarizedprescriptions were a little over $14 million, and we shipped about $12 million,because, as you know, we got distribution on those last year, and so we wantedto get those inventory levels down to this eight to ten-week level. So all ofour products are in that level now. So…

Robert Uhl - FBR

I'm sorry. I thought you said COLAZAL was 115 million ofdemand, and divided by four that's $28.75, which is lower than what your 31.1reported sales number is. That's what I'm asking about.

Carolyn Logan

Right. Well, the annualized demand is just on the morerecent data. So if you look at the nine-month comparison, that's flat. If youlook at the most recent quarter, third quarter '06 over third quarter '07 hasdeclined by about 6 or 7% in prescriptions.

So that decline is more recent and when you annualize thatout that's why the number drops a little bit. But now with Eisai on board we'rehoping to be able to come back to flat or actually what we're hoping is forgrowth in prescriptions over the previous time period.

Robert Uhl - FBR

Okay. Thanks.

Operator

And our next question will come from Greg Gust with RothCapital Partners.

Greg Gust - Roth Capital Partners

Good afternoon.

Carolyn Logan

Hi.

Greg Gust - Roth Capital Partners

Hi. Just a really quick question, in case I missed it. Isthere any or do you have any update on when you might be releasing formally thePhase II IBS data in detail in a peer review journal or a conference orsomething?

Carolyn Logan

I don't have an exact date for you on that. Bill Forbes, ourChief Development Officer and Vice President of R&D, is here. But I believethe answer is that so much data was created from that study, we were lookingfor the top line data.

He's been preparing a briefing package for his meeting withthe FDA. I would imagine Bill, am I correct in saying some abstracts will be atDDW?

Bill Forbes

That's correct. Hi, Greg. Yes, we're planning on puttingsome abstracts into DDW and we're also working with a number of key opinionleaders right now, going through the data with them and working with them tonot only pull abstracts together but also talk to them about manuscripts.

As Carolyn alluded to, there's an awful lot of data here andthat process obviously takes a little bit of time. But we're hopeful that herein the next few weeks we'll submit to DDW and we'll also in the next few monthshave something into a peer review journal.

Carolyn Logan

And, Greg, I think you probably realize that a lot of themajor medical journals have just become so strict about what you are allowed tosay about your data and them still be interested in publishing it.

So if you have noticed over this year, we have just givenvery top line results, because, I mean, we think the main thing that you'd wantto know, we know everybody wants to get down in the data, but after allprobably the most critical piece of information is, was the study successful?

And so that's what we've been communicating. But as far asgetting into details about the data, we've been very reluctant to do that,because we don't want to burn ourselves on publication.

Greg Gust - Roth Capital Partners

Yes, I understand. Perfect. Thank you very much.

Operator

And this does conclude our question and answer session fortoday. I'd like to turn it back over to you for any closing remarks.

Carolyn Logan

Thanks. And I'd just like to thank our stockholders, ouremployees and other supporters for their continued confidence and I lookforward to speaking with all of you in the future. Thank you.

Operator

This does conclude today's audio-conference. Thank you foryour participation and have a wonderful afternoon.

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