Biogen Inc. (IDP.DE) Q3 2007 Earnings Call Transcript
Published at 2007-10-23 13:25:51
: Jim Mullen - CEO Bob Hamm - EVP Cecil Pickett andPresident of R&D Paul Clancy - CFO
Geoff Meacham - J.P. Morgan Mark Schoenebaum - Bear Stearns Joel Sendek - Lazard CapitalMarkets Jim Birchenough - Lehman Brothers Eric Schmidt - Cowen and Company Bill Tanner - Leerink Swann May-Kin Ho - Goldman Sachs Steve Harr - Morgan Stanley Mike King - Rodman & Renshaw Michael Aberman - Credit Suisse Ian Somaiya - Thomas WeiselPartners Maged Shenouda - UBS
Good morning, my name is Raginaand I will be your conference operator today. At this time I would like towelcome everyone to the Third Quarter 2007 Earnings Call. All lines have beenplaced on mute to prevent any background noise. After the speakers' remarks,there will be a question-and-answer session. (Operator Instructions). Thankyou. Mr. Keith Regnante, Director of Investor Relations, you may begin yourconference.
Thank you. Thank you and welcometo Biogen Idec's earnings conference call for the third quarter of 2007. Beforewe begin I would encourage everyone to go to the Investor Relations section ofour website biogenidec.com, to print out the press release and relatedfinancial tables. You will find these particularlyuseful when our CFO, Paul Clancy, reviews the financial results and thereconciliation to non-GAAP financial measures discussed today. We have alsoposted slides on our website that outline the topics discussed on today's call. As usual, we will start with the Safe Harborstatement. Comments made on this conference call include forward-lookingstatements about the company's expectations regarding future financial results,including our 2007 financial guidance, our longer term operational andfinancial goals, the sales potential of TYSABRI and RITUXAN, and plans forexternal growth and pipeline advancements. Such statements are subject to risksand uncertainties which could cause actual results to differ materially fromexpectations. In particular, careful consideration should be given to the risksand uncertainties that are described in our earnings release and in Item 1A ofthe company's quarterly reports on Form 10-Q and in other periodic and currentreports Biogen Idec files with the SEC. The company does not undertake anyobligation to publicly update or -- any forward-looking statements. Today on the call I'm joined byJim Mullen, CEO of Biogen Idec, Bob Hamm, Executive Vice President, CecilPickett, President of R&D, and Paul Clancy, our CFO and Executive VicePresident of Finance Now I will turn the call over toJim Mullen.
Thank you, Keith, good morningeveryone. We have had an eventful few weeks at Biogen Idec, we will use thiscall to take you through the details of our quarter, as well as touch on someof the larger topics. I will mention just a few highlights before I turn thecall over to Bob, Cecil, and Paul. To start, our business plan isworking; we're making progress on our goals for the year. Specifically we aredriving continued revenue growth, successfully expanding TYSABRI use in both US andinternationally and the pipeline is progressing well. We closed another business developmentdeal with Cardiokine for the end of Phase II lixivaptan program. The upfrontfee was $50 million, which we told you about on the last call, and that was$0.11 for the quarter. The major disappointment in my view was the AVONEXsales, which were weak in August in both the US and some of our foreign tendermarkets but has rebounded nicely in September. Overall the year is unfolding asplanned and we are on track to meet our full year 2007 financial guidance,which we raised last quarter. Further, we remain confident, we are wellpositioned to meet our long term goals out to 2010, which include delivering onthe strong revenue growth, specifically this means 15% top line growth drivenin part by the 100,000 patients on TYSABRI by year end 2010. We also expect to see 40% of the company'srevenue coming from the international business. So that is up from 30%,approximately 30% today. The next goal is building, continuing to build arobust pipeline and executing on the clinical development. We are well on ourway towards achieving this goal with 15 product candidates in Phase II clinicaltrials or beyond and at least 10 data readouts through the end of 2008. The goal by 2010 is to file atleast two additional indications for the CD20 franchise, and have two newproducts or major indications launched. You will hear more on the pipeline fromCecil on this call. Additionally, we're aiming forstrong financial performance. This means leverage the top line growth anddeliver 20% non-GAAP EPS compounded annual growth rate from '07 through 2010. Now, as I am sure you are awarewe have started a process to explore a possible sale of the company. Let mayremind you that both management and the Board are confident that the businessoutlook for Biogen Idec as a stand-alone company will result in attractivevalue for shareholders and we believe our strategy is working and has beengenerating and will generate strong operating and financial performance. But wedo operate in a larger environment with large multinational pharmaceuticalcompanies and after several expressions of interest, including by Mr. Icahn,the Board has authorized management to explore whether a potential sale to athird-party might result in superior value to shareholders at this time. Whilewe cannot provide many details beyond what was in the October 12 press releasewe will say that a process like this typically takes a number of months to playout, and we will work to get through this process as quickly as is reasonable. Finally, it's important to remindeverybody that there is no guarantee that an acquisition of the company willoccur at the end of this process. With that said we will spend the remainder ofour time walking through our Q3 performance, as well as, providing a bit moredetail on our 2010 operating and financial goals. And I will now hand the call overto Bob Hamm.
Thanks, Jim. Let me start off byreminding everyone of what we have reminded people of in the past but it bearsrepeating, at Biogen Idec we have the number one prescribed MS therapy today inAVONEX. Two, we have the product to establish a new level of efficacy, TYSABRI,which has been shown to delay the progression of the disease and reducerelapses by two-thirds. And finally, we have the best and broadest pipeline ofMS compounds for the future. As Jim has mentioned, our goal isto generate revenue growth at a 15% compound annual growth rate and non-GAAPEPS at a 20% compounded annual growth rate from 2007 through 2010. Clearly theneurology business, which currently has a run rate of over $2 billion in annualrevenue is a key contributor to that goal. Specifically, I would like tocomment on three of the key drivers. First, continued solid performance ofAVONEX, the world's leading MS treatment. In May, AVONEX celebrated its 11thanniversary and remains the world's most prescribed therapy with over 135,000patients worldwide. It remains the foundation of our global MS business, whichhad $518 million in revenue this quarter, growing 12% year-over-year. Combinedmarket share of AVONEX and TYSABRI is approximately 40% in the US andis expected to grow. Second achieving the milestone of100,000 patients on TYSABRI by year end 2010, TYSABRI has now been on themarket in the USfor almost 15 months and is available in many European and other countries.Another significant milestone has recently been achieved with over 17,000patients on therapy worldwide in the commercial and clinical settings and over2,100 physicians prescribing in the US alone, including 94 of the top100 based on IMA volume. Momentum continues to build withmore and more patients starting therapy, and more and more physiciansprescribing everyday. We are confident that TYSABRI will achieve the goal of100,000 patients on the therapy by year end 2010. Finally, continued geographicdiversification of its revenue base with more than 40% of revenue frominternational business by 2010. Our neurology business already derives asignificant portion of revenues from outside the US with international revenuesrepresenting over 40% of the total. We will continue to rapidly expand ourglobal footprint and drive results, beyond 2010. We are currently the leader inMS, and we will extend our leadership position into 2010 and beyond with ourrobust pipeline that has four products in Phase II or beyond, those beingBG-12, RITUXAN 2H7, oral VLA-4 and daclizumab. Turning to TYSABRI andsummarizing the results; TYSABRI continues to build momentum, as many of youare aware we had a significant presence at ECTRIMS this year, where weannounced that as of the end of September there are over 17,000 patients ontherapy globally, including 10,500 in the US, 5,500 in EU, and around 1,000in clinical trials. As anticipated summer was slower in Europe,we will continue to accelerate uptake as the number of prescribing physiciansand the number of countries with reimbursement increases throughout theremainder of 2007. We now have the over 2,000patients on therapy for longer than one year and no new reports of confirmedcase of PML as of mid-September. The AFFIRM study showed that 64.3% ofTYSABRI-treated patients were disease-free or without relapses and disabilityprogression. And 36.7% had no relapses, disability progression, or MRIactivity. Additionally, results from the PLEX study suggest that plasmaexchange may be an effective means of accelerating the removal of TYSABRI fromthe blood serum. We are also moving forward withclinical trials to support the TYSABRI marketing effort. In order to definitivelyshow the efficacy of TYSABRI compared to marketed competitors, we're planninghead-to-head switching trials. Additionally, we're concerned that patients maybe experiencing delays before moving to the most effective therapy and we aredesigning trials to potentially address this. We plan to initiate thesehead-to-head switching trials in early 2008. It is clear that neurologists andpatients are increasingly choosing TYSABRI given its significant impact onclinically meaningful and relevant endpoints, including relapses and disabilityprogression. Turning to the US and the source of patients in the US, four out offive patients prescribed TYSABRI are new to the Biogen Idec franchise.One-third of TYSABRI patients are returning quitters and naive patients, whichis expanding the market. As we have reported in previous earnings calls,glatiramer acetate, with its 365 injections per year, continues to be thesingle largest source of TYSABRI patients year-to-date. Internationally, about 5,500patients were on therapy in Europe as of theend of September. Germany, France, Italy,and Greececontinue to provide the majority of new patients being dosed with TYSABRI. Asof the end of August, we estimate TYSABRI to achieve a 4.4% MS market share inGermany, 7% in Sweden, 6.4% in Denmark, 6% in Ireland, 6% in Greece, and in acouple of months 2% in France. It is expected that the momentumin international markets will continue to accelerate throughout the year,driven by France,which launched in early June. It is the second largest MS market in Europe and is currently our number two market in terms ofTYSABRI-treated patients. In the UK, the National Institute forHealth and Clinical Excellence has recommended the use of TYSABRI to treatpeople with highly active relapsing-remitting MS in recognition of its superiorcost and efficacy benefits. Reimbursement has been approved on a national levelalthough widespread reimbursement availability will likely start in Q4. TYSABRIis the first treatment for MS to be recommended for use by NICE. Since the last earnings callTYSABRI has received approval in New Zealandand reimbursement in the UKand Belgium.Czech Republicand Sloveniaare expected to launch in Q4 '07 with reimbursement expected in early '08. Theinternational rollout is expected to continue throughout 2007 and into 2008with 23 countries expected to have launched by the end of this year. Key launch countries in 2008should include several of our distributor markets in Latin America and theMiddle East, as well as, Australia.On slide 16, we show the TYSABRI end user sales. We're making solid progress inboth the USand international, as you can see from the ramp of in-market or end user salesin MS. Turning to Crohn's, as weannounced last week Biogen Idec and our partner on TYSABRI Crohn's, Elan, havebeen informed by the FDA that the agency requires additional time to reviewinformation regarding the proposed TYSABRI risk management for Crohn's disease.Under this revised timeline the companies anticipate action from FDA on orbefore January 13, 2008. Approximately 1 million people worldwide have Crohn'sdisease, a chronic and progressive inflammatory disease of the gastrointestinaltract which commonly affects both men and women. Currently there is no medicalor surgical cure for Crohn's disease, many patients fail to respond to currenttherapies including biologic therapies such as the TNF alphas. Due to this failure of currenttherapies in CD, therapies such as TYSABRI that have novel biological targetsare required. In addition we continue to work on other indications for TYSABRIincluding exploring potential applications in oncology. Moving over to AVONEX, AVONEXremains the most prescribed therapy worldwide and the number one therapy in theUSfor more than 10 years. Although we saw a slight dip in the current quarterleading to a drop in the AVONEX US revenue of 0.7% year-over-year, market sharein the UShas remained extremely stable for the past 12 months. We're beginning to see the impactof TYSABRI on the ABCR market in the US, which is now flat to decliningon a year-over-year basis. Internationally AVONEX revenue grew at 7% in Q3 '07year-over-year, with its long-term efficacy profile including many years ofexperience in the physician and patient communities and its number oneposition, AVONEX remains the product to start with. Of course, for those whoneed more efficacy TYSABRI is the appropriate choice. With the number one prescribed MStherapy today in AVONEX, a product that has established a new level of efficacyin TYSABRI, and the best and broadest pipeline of MS compounds for the future,we are the leaders in MS. We continue to recognize MS patients need moreoptions since they will have this disease for decades and it is unlikely onlyone drug will be appropriate over the course of their disease. From diagnosisto disease resolution we're amassing the highest quality portfolio of compoundsto address the unmet needs of people with MS to 2010 and beyond. I will now hand the call over toDr. Cecil Pickett, our President of R&D.
Thank you, Bob. This quartermarks my one-year anniversary with Biogen Idec and I continue to be impressedby the caliber of our R&D team. I also feel good about the strength,continued progression, and balance of our pipeline, which includes both lineextensions and novel molecules addressing potentially large markets. Today, I would like to report onour recent accomplishments and upcoming data readouts. First I will provide anupdate on some of our R&D accomplishments for the quarter, then, from amongthe 15 programs we have in late-stage development, I will summarize twonear-term data readouts. Specifically, I will focus on the daclizumab Phase IICHOICE data that was recently presented at the ECTRIMS meeting and theLT-beta-R-Fc Phase IIa data which will be presented at the American Collegeof Rheumatology meeting in November. Finally I will close by reminding you ofthe several upcoming data readouts, which we're expecting by the end of 2008. Starting with our R&Daccomplishments for the quarter; we at Biogen Idec continue to make strongprogress on enriching and advancing our pipeline. We continue to advance anddevelop our clinical pipeline. We continue to accrue patients in ourregistration stage programs of lumiliximab in CLL, volociximab in NHL, andBG-12 in relapsing-remitting MS. We also achieved first-patient-in milestonesfor several programs, including a BIIB14 Phase IIa trial in Parkinson's;voluciximab or M200 Phase II ovarian cancer trial, and LT-beta-R-Fc Phase IIbprogram. In addition we filed IND applications for ourneublastin and Factor IX programs. We believe we have a solid pipeline that isprogressing well with a good balance of both risk and potential returnrepresented. We also published a paper on our LINGOprogram in an animal model of multiple sclerosis which is highlighted on thecover of the October issue of Nature Medicine. We showed that anti-LINGO-1antibody can promote spinal cord remyelination and axonal integrity. Whilestill early in development we believe our LINGO program has the potential forbroad application and significant benefit to patients with MS and otherneurodegenerative disorders. We also continued to successfullyexecute our external growth strategy. In early July we announced an agreementwith Cardiokine to jointly develop lixivaptan, an oral vasopressin receptorantagonist expected to enter Phase III clinical trials this year for thepotential treatment of hyponatremia in patients with congestive heart failure. Now, let me move on to two veryimportant near-term data readouts; starting with daclizumab, which we co-developedwith our partner, PDL BioPharma, for relapsing-remitting MS. As you may haveseen the Phase II data from the CHOICE trial of daclizumab inrelapsing-remitting MS was recently presented at a platform session at ECTRIMS.This randomized placebo-controlled trial looked at daclizumab added on standardinterferon beta therapy in 230 patients. We examined two doses ofdaclizumab and the higher 2 milligram per kilogram dose every other weekreduced new or enlarging gadolinium-enhancing lesions between weeks 8 and 24 by72% compared to interferon alone with a P value of 0.004, thus meeting theprimary endpoint. While not powered to show significance for the secondaryendpoint of reduction in relapse rate both doses showed a trend towards a 34%reduction in annualized relapse rate. Keep in mind, these efficacy results wereon top of background interferon therapy. The safety we saw also supportedmoving forward into the Phase IIb clinical studies. We have said we expect toinitiate the second Phase II SELECT trial looking at daclizumab as monotherapyby year-end 2007. Moving to LT-beta-R-Fc; as wehave indicated, we accelerated the clinical development of LT-beta-R-Fc inrheumatoid arthritis and are actively enrolling patients in a robust Phase IIbprogram. We plan to enroll a total of 500 patients across two trials generatingrandomized efficacy data in both DMARD inadequate responders and TNF inadequateresponders. The primary endpoint in both trials is ACR 50 at three months. Wealso expect to identify the correct dose, potentially a once-a-monthsubcutaneous injection. We will present the Phase IIadata that encouraged us to accelerate into Phase IIb development at the American College of Rheumatology Meeting in aposter presentation on November 9. The abstract is available online at the ACRwebsite. We examined standard components of the ACR scoring system, such astender and swollen joint count, at one month and explored multiple doses. Theabstract indicates 48 patients with moderate to severe RA and inadequateresponse to DMARD continued methotrexate and received subcutaneous LTBR-Fc atone of six doses or placebo once weekly for 4 weeks, followed by 8 weeks ofobservation. The interim results showed that at day 35, swollen joint count wasreduced by a median 61% from baseline in LT-beta-R-Fc patients versus 0% inplacebo patients with similar patterns in tender joint count and other ACR coreset measures. We will provide an update at the poster session, which Iencourage you to attend. Now I will touch on data readoutsin 2008. We are expecting to see data from at least 10 clinical trials by theend of 2008. These include readouts in additional indications for RITUXAN suchas DMARD inadequate responders in RA, primary progressive MS, lupus, and CLL.We will also see readouts from novel programs such as the heat-shock protein 90inhibitor and volociximab in solid tumors, the Phase IIb data on LT-beta-R-Fcin RA, CDP323 in relapsing-remitting MS, long-acting Factor IX in hemophilia B,and BIIB14 for Parkinson's disease. In closing, as I outlined duringour R&D day last spring, 2007 is very much a year of execution while 2008is poised to be a year of results. I hope you come away with some of the sameexcitement we have for the pipeline. With that I will hand the call over toPaul Clancy, our CFO.
Thank you, Cecil. As usual, Iwould like to use this call to review our quarterly financial performance. TheGAAP financials are provided in Tables 1 and 2 of the earnings release. Table 3is a reconciliation of the GAAP to non-GAAP financial results. So let's beginwith our GAAP to non-GAAP reconciliation. In accordance with Regulation G wehave provided Table 3, which breaks out the reconciling items by major driver.The main items excluded from the operating non-GAAP P&L in Q3 were; First,we adjusted $96 million in purchase accounting charges for the amortization ofintangibles in in-process R&D expense. These include charges related to theBiogen Idec merger as well as the Conforma, Syntonix, Fumapharm, and Cardiokinetransactions. Second, we adjusted $38 millionfor the consolidation of Cardiokine and again on the sale of certain long-livedassets. Third, we adjusted $9 million in pre-tax employee stock optionexpenses. $6 million of this adjustment is in SG&A, while the remaining $3million is in R&D. Fourth, we had $17 million of tax impact of the items Ijust mentioned. Now, I will move on to thenon-GAAP P&L operating performance. We believe it is important to sharethis non-GAAP P&L with shareholders because it better represents theongoing economics of our business. It reflects how we manage the businessinternally and it forms the basis of our management incentive programs. In Q3while we delivered $0.41 diluted EPS on the GAAP P&L, after the adjustmentsshown on Table 3, our non-GAAP diluted EPS was $0.58. Now let's move through the thirdquarter non-GAAP P&L results in a bit more detail. Q3 total revenue was$789 million, which represents 12% growth over the same period last year.Revenue for the first nine months of the year totaled approximately $2.28billion, representing a 15% growth over the same period last year. Key driversof this year-over-year increase, include the continued growth of theinternational AVONEX business, the reintroduction and increasing penetration ofthe TYSABRI business, and the continued growth of the RITUXAN franchise. For the third quarter, BiogenIdec's MS franchise grew by 12% since last year. With the launch of TYSABRI wecontinue to grow the MS market, as new patients and former quitters join themarket. Going through our productrevenues, I will begin with AVONEX, the number one worldwide MS product. Youmay recall, Q3 last year, was a very strong quarter for the worldwide AVONEXbusiness. Thus, I think it is useful to mention both a quarterly andyear-to-date growth rate when discussing AVONEX's performance. Q3, AVONEXworldwide product revenue was $455 million, which represents a 2% increase overthe same period last year. Revenue for the first nine months of the yeartotaled approximately $1.37 billion, which represents an 8% increase over thesame period last year. Q3, US AVONEX product revenue was$266 million, representing a 1% decrease over the same period last year.Revenue for the first nine months for US AVONEX totaled $806 million,representing a 6% increase over the same period last year. Q3, internationalAVONEX product revenue was $189 million, representing an increase of 7% on ayear-on-year basis. Revenue for the first nine months for AVONEX internationaltotaled $559 million, representing a 10% increase over the same period lastyear. The quarterly increase for AVONEX international was driven by, favorableforeign exchange rates. Direct and JV markets continue to perform well, asrevenue increased in these markets by over 9%, of which approximately,one-third was due to volume and two-thirds due to foreign exchange rates. Now moving to TYSABRIperformance, Q3, TYSABRI worldwide product sales for Biogen Idec were $63million. As Bob highlighted, TYSABRI continues to make strong progress. TYSABRIend-patient revenue totaled $93 million. In the US, end-user or in-market TYSABRIsales totaled $59 million, which represents a 25% quarter-over-quarterincrease. Biogen Idec booked $28 million of this amount. Internationally, end-user orin-market TYSABRI sales totaled $35 million, which is a 38% increase from theprior quarter. Additionally, you will note that our collaborationprofit-sharing line has become positive, this quarter. This line representsBiogen Idec's payment of 50% of profits outside the USto Elan and the reimbursement of third-party royalties, incurred by Elanoutside the US.We expect this number to continue to grow in the coming quarters, reflectingthe growing profitability of our international TYSABRI business. Moving now to other productrevenue, Q3, ZEVALIN product sales were $4 million. We signed an agreement withCell Therapeutics, who will acquire ZEVALIN. In August, Cell Therapeuticsannounced that it would pay Biogen Idec, $10 million in upfront cash, up to anadditional $20 million in future milestone payments and ongoing royalties, onsales. The $10 million upfront payment will be recognized in our operatingresults over the term of our supply agreement. We anticipate the sale willclose in the fourth quarter of 2007. FUMADERM revenue was $7 million.As we mentioned in our last earnings call, we took over distribution ofFUMADERM in early May, and at that point we began shipping inventory andrecognizing revenue. Q3 is the first quarter that we recognized, three fullmonths of revenue. Now moving on, to the RITUXANcollaboration revenues, which is referred to as revenue from unconsolidatedjoint business. We recorded $235 million in revenue, representing an increase a15% on a year-over-year basis. As we always discuss, this number has severalelements. First, we receive our share of the US RITUXAN profits. As reported byour partner Genentech, US RITUXAN sales were $572 millionin the third quarter; and our Q3 profit share, from that business was $156million, up 13% versus prior year. Second, we receive royaltyrevenue on sales of rituximab outside the US; and in Q3 this was $63 million,up 22% versus prior year. Third, we were reimbursed $15 million for selling anddevelopment costs, incurred related to RITUXAN. Finishing our revenueperformance, third quarter royalties were $24 million. Now turning to the expense lineson the non-GAAP P&L, Q3 cost of goods sold, were $82 million. Thisrepresents 10% of revenue. Q3 R&D were $282 million, this represents 36% ofrevenues. I should note that this R&D spend includes $50 million upfrontpayment to Cardiokine for the recent transaction, relating to the late-stagelixivaptan program. This $50 million payment equates to $0.11 diluted earningsper share. Adjusting for this upfront payment, R&D as a percent of revenuewould be approximately 29%. I do think it is useful toreiterate that our pipeline continues to grow and advance. We currently have 15programs in Phase II or beyond, and we expect at least 10 data readouts in thenext 14 to 15 months. Q3, SG&A were $185 million, this represents 23% ofrevenues in 11% year-over-year increase. You'll notice that there was a slightdecline in SG&A as a percentage of revenue in Q3, when compared to lastquarter. As we mentioned during the last earnings call, we're in the midst of amajor TYSABRI marketing effort in the US,as well as a country-by-country rollout in Europe. These launch activities haverequired us to significantly increase, our SG&A investments over the lastquarters. However, as revenue has continued to grow, we're benefiting fromincreased leverage from these investments. Q3, other income and expense was $7million. The most significant change to our OIE line since, last quarter is theimpact of our $3 billion share repurchase. Specifically, this line has beenimpacted by the loss of interest income on $1.5 billion in cash and theinterest expense on $1.5 billion in debt. I should also note that the OIE lineincludes a gain of $11 million from the sale of certain equity investments. Moving to our Q3 tax rate, thenon-GAAP Q3 tax rate was 29.6%, which is consistent with the guidance we issuedduring our previous call, where we mentioned that we expect the balance of yeareffective non-GAAP tax rate, to be in the 28% to 30% range. Our year-to-datenon-GAAP tax rate is 27.1%. This rate is lower than our Q3 tax rate, driven bya couple of factors. First, the IRS completed its audit for fiscal years 2003and 2004, leading us to record an immediate $15 million reduction in taxliabilities in the second quarter. Second, we continued to benefitfrom an increasing ratio of international income, including the impact of ourrecent capital restructuring. After adjusting for the impact of the IRS audit,our year-to-date non-GAAP tax rate is 28.4%. This brings us to our Q3 non-GAAPdiluted EPS of $0.58. So in conclusion, our top-line revenue growth was 12% ona year-over-year basis. We continue to increase the worldwide penetration ofTYSABRI, and we continue to progress our pipeline both internally as well asthrough our external growth strategy, as evidenced by the recent Cardiokinetransaction. I would like to close byreiterating our 2007 non-GAAP P&L financial guidance. As we mentioned onour last call, we expect annual revenue growth in the 16% to 18% range and abottom-line EPS growth rate in the 16% to 20% range. We expect a 2007 non-GAAPdiluted EPS in the range of $2.60 to $2.70. On a GAAP basis, this translates2007 diluted EPS in the range of $1.84 to $1.94, excluding any futureacquisitions or other transactions. We are excited about thecontinued growth prospects for Biogen Idec, driven by the continued success ofour commercial products. In advancing the pipeline we believe that we willcontinue to generate strong top-line and bottom-line growth. Now I will handthe call over to Jim for his closing comments.
Thank you, Paul. In summary, theyear is unfolding as planned and we are well on track to hitting our 2007financial guidance, which I will remind you we revised upward earlier thissummer. The underlying business remains strong. We have made good progress withboth TYSABRI and the pipeline and I think that really is the key takeaway. Thetop-line remains strong, and we are making good progress on TYSABRI, and thepipeline progress has been excellent. So underlying this, we do remainfocused on bringing meaningful therapies to patients in need and, at the sametime, delivering value to our shareholders. Just before I hand the call back toKeith for questions-and-answers, let me touch one last time on the process we havebegun to explore a potential sale of the company. I know this is an uncertain timefor employees and investors alike and that there is a great thirst for anyrelated information. However, I am sure you can understand this is a sensitiveissue on a number of fronts. I have gone as far as I am able, on this topic. Atthis point, it would be inappropriate for any of us to discuss additionaldetails. And I think we make better use of our limited time inquestions-and-answers with questions about the quarter than in pursuing thelanguage of our October 12th press release. So with that, Keith, let's open itup to Q&A.
Thank you, Jim. Operator, we are now ready to open up thecall for Q&A. We do ask the participants on the call to please limitthemselves to one question and then please reenter the queue to ask follow-upquestions. Also, please state your name and your company affiliation. Operator,we will now take the first question.
(Operator Instructions). Your first question comes fromGeoff Meacham of J.P. Morgan.
Hi, guys. A quick question for you on your most recentpatient numbers for TYSABRI. It looks like the new starts in US have picked up.Can you give us a sense for -- have you seen an increase in the number ofpatients on TYSABRI in existing tech centers? Or have you also seen an increasein the number of tech centers and sort of new doc's prescribing TYSABRI? J.P. Morgan: Hi, guys. A quick question for you on your most recentpatient numbers for TYSABRI. It looks like the new starts in US have picked up.Can you give us a sense for -- have you seen an increase in the number ofpatients on TYSABRI in existing tech centers? Or have you also seen an increasein the number of tech centers and sort of new doc's prescribing TYSABRI?
Thanks Geoff, this is Bob Hamm. Yes, in fact, both. It'syes, to both questions. We continue to see a weekly increase in new prescriberscoming on. I would also add that since July we have seen about 25% increasesustained in new tech starts coming in. And the fact remains that getting thephysicians started, getting them used to the program, allows them to getcomfortable with it. The more they use the product -- the more they use theproduct is kind of what we are saying and we would expect that evolution tocontinue.
Just a quick follow-up if I can on that same patient numberfrom Europe. It looks like in your last datacut the European new starts look a little bit weak in August. Have you guysseen -- that is not a surprise, I guess, given the vacation season. Have youguys seen a pickup in September in some of the new geographies that you havelaunched? J.P. Morgan: Just a quick follow-up if I can on that same patient numberfrom Europe. It looks like in your last datacut the European new starts look a little bit weak in August. Have you guysseen -- that is not a surprise, I guess, given the vacation season. Have youguys seen a pickup in September in some of the new geographies that you havelaunched?
This is Bob. I think as you know, the European numbers inseveral countries are very sketchy. You have to extrapolate from wholesalerdata and whatnot, so it is not that reliable. Yes, after the summer ends, withincreasing countries that we said and increasing physician prescriber base, wewould expect the growth to continue.
All right. Thanks. J.P. Morgan: All right. Thanks.
Your next question comes from Mark Schoenebaum of BearStearns. Mark Schoenebaum -Bear Stearns: Hi, Jim, I don't know if you want to answer this question,but I just got to ask. Can you maybe talk to us a little bit about why you guysmade the decision to go public with the announcement, rather than keep thatprivate? And if you won't answer that, I have a quarter question.
This is an either-or, is it, Mark? Well, yes, I can addressthe first one. I think, there was, a couple of issues. One, I don't think it isreally even possible to run a process very quietly behind the scenes and alsoexplore broadly all the parties that could be interested. So that was a verypragmatic view. And secondly, I felt we had a need to be able to talk asdirectly as possible to both the shareholders as well as the employees aboutwhat was going on. And then lastly, this allows us, to keep this process asshort as humanly possible because as you can appreciate, going through a periodlike this creates a lot of uncertainty in the company among employees. It isjust unsettling. It is not different here than anywhere else, and I would liketo get that past us as quickly as possible. Mark Schoenebaum -Bear Stearns: May I ask my quarterly question?
Okay. Mark Schoenebaum - BearStearns: Okay, is very simple, actually, maybe for Bob. Can you justgo over -- can you give us your share for AVONEX in the US and the year-over-yearcomparison in the same for international? If you don't mind, patient share andI really appreciate you answering both questions.
Sure, Mark. The issue in Europe,as I said, is difficult to assess. The fact is AVONEX has been the number oneproduct for many years. And as I reported, the ABCR segment is decliningyear-over-year, but the AVONEX share remains very stable with its leadershipposition throughout the world. Mark Schoenebaum -Bear Stearns: In US?
Your next question comes from Joel Sendek of Lazard CapitalMarkets.
Thanks. I have a question on the revenue guidance. If youlook at the numbers your revenue growth is up 15% year-to-date and only 12% inthe third quarter. So, I am wondering why -- what you are seeing in the fourthquarter to reiterate the 16% to 18% growth? Because as I do the math it lookslike you are predicting pretty strong revenues in the fourth quarter. Lazard Capital Markets: Thanks. I have a question on the revenue guidance. If youlook at the numbers your revenue growth is up 15% year-to-date and only 12% inthe third quarter. So, I am wondering why -- what you are seeing in the fourthquarter to reiterate the 16% to 18% growth? Because as I do the math it lookslike you are predicting pretty strong revenues in the fourth quarter.
Yes, Joel, so I would say we are expecting a bit of anacceleration versus what we have today, right now and included in that is a pickupof the TYSABRI which is -- we are seeing on a sequential quarter basis and Iwould say that is probably the biggest driver for the fourth quarterexpectation.
Thank you. Lazard Capital Markets: Thank you.
The next question comes from Jim Birchenough of LehmanBrothers.
Yes, hi guys. Just wanted totouch on your guidance -- long term guidance and it seems central to that isAVONEX maintaining patient share. And I'm just wondering if you could commenton some of the challenges to that including the impact you have described onthe ABCR drugs, the sequential decline, and potential competitors? We areseeing a fair amount of data from compounds like Campath and FTY720. What givesyou the confidence in the long term sustainability of AVONEX trends? LehmanBrothers: Yes, hi guys. Just wanted totouch on your guidance -- long term guidance and it seems central to that isAVONEX maintaining patient share. And I'm just wondering if you could commenton some of the challenges to that including the impact you have described onthe ABCR drugs, the sequential decline, and potential competitors? We areseeing a fair amount of data from compounds like Campath and FTY720. What givesyou the confidence in the long term sustainability of AVONEX trends?
Yes, this is Jim, let me take acrack at that. So, I think what I have said to people as we have been out toall the investors that we have been at over the last six weeks is, ourexpectation in the USis that it, on an absolute basis, is sort of flat to a little bit down. Outsidethe USit will be modestly increasing, in part that is driven because we are taking onsome new markets here and incorporating sales that we didn't have before bygoing direct in some of these markets. So, you look at Brazil, Argentina,Japan,etcetera. So, you get some growth out of new geographies even though the, ifyou will, the more mature geographies are going to be relatively flat or evenpossibly modestly declining. But with the TYSABRI we are alsobringing in a pretty big chunk of new patients back into the market. So, athird of these patients are patients that have fallen through the differenttherapies. So, I think that is the offset that we see as you sort of balanceall this out. The more mature geographies will be challenged and a lot of thegrowth is going to go to TYSABRI but we still have some new geographies thatare relatively unpenetrated that will show up as new sales for us.
And just a -- just a follow-up,how do you see the competitive landscape playing out when you look at some ofthe emerging therapies and also if you could just touch on consideration forpotential generic entrants, what the timing of that might be? LehmanBrothers: And just a -- just a follow-up,how do you see the competitive landscape playing out when you look at some ofthe emerging therapies and also if you could just touch on consideration forpotential generic entrants, what the timing of that might be?
Yes, well, we have assumed thatFTY720 would come to the market; we have assumed that Campath will come to themarket. As a purely practical matter that is at the tail end of this sort oftimeframe of '07 or '10. So those would, you know, might get into themarketplace in the last -- in the 2010. So, the impact in the near term isrelatively modest to very little. Relative to the genericcompetition, in Europe there is anothercompetitor that will probably come to market that is the BioPartner’s productbut that is not truly a biogeneric that will have been a full developmentprogram, others may come, but there are still some patents out there. It reallyis product-by-product dependent on whether some of these remaining patents willblock new entrants. So, the closer they are to an identical to Interferonbeta-1a, I think the more difficulty they're going to have getting to themarketplace.
Thanks for taking the question. LehmanBrothers: Thanks for taking the question.
Your next question comes fromEric Schmidt of Cowen and Company.
Good morning, question about theTYSABRI guidance for 100,000 patients on drug by the end of 2010. I'm justwondering what kind of assumption or expectation for the incidence of PML underliesthat guidance. Cowen andCompany: Good morning, question about theTYSABRI guidance for 100,000 patients on drug by the end of 2010. I'm justwondering what kind of assumption or expectation for the incidence of PML underliesthat guidance.
Well, the expectation for the PMLis what we have in the label and the market research would indicate that mostof the physicians, they believe that that is either the actual incidence orgiven the current safety experience in the commercial setting that perhaps itis a bit lower than that. So -- our expectation is that we will see someinstance of PML similar to the label. And just to add a couple morethings, you know, one of the things that makes the difference when people sortof sit back and think about it is, is our expectation is that something over50% maybe approaching 60% of the TYSABRI sales will ultimately be ex-US marketsand of course the balance in the US market and we are expecting some modestcontribution to that 100,000 from Crohn's.
Thanks, Jim. Cowen andCompany: Thanks, Jim.
(Operator Instructions). Yournext question comes from Bill Tanner of Leerink Swann.
Thanks for taking the question. Aquestion maybe for you, Bob, or a couple of them, you did mention doing somehead-to-head studies, TYSABRI with some of the other drugs and you also, Ithink I heard you say that there has been a delay in switching patients. I amcurious, a couple of things, one is the delay, is that just the absence ofdata, or is that some negative detailing? And secondly then, on thehead-to-head, would you contemplate just needing relapse reduction or going atleast a couple years and looking at changes in disability? Thanks. Leerink Swann: Thanks for taking the question. Aquestion maybe for you, Bob, or a couple of them, you did mention doing somehead-to-head studies, TYSABRI with some of the other drugs and you also, Ithink I heard you say that there has been a delay in switching patients. I amcurious, a couple of things, one is the delay, is that just the absence ofdata, or is that some negative detailing? And secondly then, on thehead-to-head, would you contemplate just needing relapse reduction or going atleast a couple years and looking at changes in disability? Thanks.
Okay Bill, on the head-to-headtrial basis I think it is important to look out to the future and where themarket will be, and how payers will make decisions in the future. Therefore,robust head-to-head trials, we haven't seen many of these but it would make abig difference in the way certain groups look at this situation. In terms ofswitching patients, just get back to the fact that four out of the fivepatients who are coming to TYSABRI are new to Biogen Idec that means they areeither switching or coming from the quitter-naive pool that Jim mentioned, andtherefore, it is a matter of going after some physicians who may want to seemore clinical evidence in certain quarters. But already we are seeing that fourout of five patients are coming from the other products and the othercategories.
Okay, thanks. Leerink Swann: Okay, thanks.
Your next question comes fromMay-Kin Ho of Goldman Sachs. May-Kin Ho: Can you refresh our memory, whatkind of manufacturing capacity do you have at this point and what would that beby 2010? And then lastly just a quick question on the quarter, can you breakout for us the interest income versus interest expense? Goldman Sachs: Can you refresh our memory, whatkind of manufacturing capacity do you have at this point and what would that beby 2010? And then lastly just a quick question on the quarter, can you breakout for us the interest income versus interest expense?
Interest income versus -- okay, Iwill turn that one to Paul in a second, manufacturing capacity I assume you aretalking about for TYSABRI. May-Kin Ho: No, for the company. Goldman Sachs: No, for the company.
For the company? Yes, we havelicensed in North Carolina90,000 liters of large-scale capacity in two purification suites; in additionthere are three trains at the 2,000 liter capacity that run independently ofthat. In Cambridge-- and so both of these products are licensed multi-product facilities. In Cambridge, we have fivetrains that we can run and we run them in combinations of clinical, as well as,commercial material. And the Danish facility is another 90,000 liters oflarge-scale capacity that will come online approximately this time next yearand then go through the licensure process and that would be online for commercialproduct somewhere in 2009. May-Kin Ho: Can you put it in context for us,what is this in context of the worldwide capacity? Goldman Sachs: Can you put it in context for us,what is this in context of the worldwide capacity?
Worldwide capacity of what, whatis the denominator I am trying to work with here? You mean biologics? May-Kin Ho: Yes, biological mammalian. Goldman Sachs: Yes, biological mammalian.
I don't know, I would think thisprobably puts us about number three in the world around -- if you look atWyeth's capacity and Genentech's, I think we may be the next one behind that,it could be BI is a little bit around that but we are certainly in the topfive. May-Kin Ho: Okay, thank you. Goldman Sachs: Okay, thank you.
Your next question comes fromSteve Harr of Morgan Stanley.
Just a little more granularity onthe AVONEX franchise, if you take out currency and price increases, could youjust give us your year-over-year volume trends in the US and Europe? And thenfollow that up with just -- should we expect going forward that with your100,000 patient goal that you would see 20% of those patients leaving AVONEX?So, we would have potentially 20,000 patients in declining volume over the nextseveral years. Morgan Stanley: Just a little more granularity onthe AVONEX franchise, if you take out currency and price increases, could youjust give us your year-over-year volume trends in the US and Europe? And thenfollow that up with just -- should we expect going forward that with your100,000 patient goal that you would see 20% of those patients leaving AVONEX?So, we would have potentially 20,000 patients in declining volume over the nextseveral years.
Yes, I would say just to addressthe last question, there was some interference there, but as I understood it --what we would expect to see is the ABCRs obviously being affected, as we haveseen in the first year and a half of TYSABRI activity but that AVONEX sharewould remain stable within that group and therefore we would see it relativelyflat going forward with the growth in the overall market and whatnot.
Did you want to go back toMay-Kin Ho's question on the interest?
May-Kin, this is Paul. I will go back to -- you had aquestion on the interest income and interest expense, those numbers wereroughly -- interest income being right around $15 million, interest expensebeing right around $20 million. And as I had mentioned in the OIE line we didhave a gain on an equity investment of $11 million.
Could you follow up and answer the volume question as wellthere? Morgan Stanley: Could you follow up and answer the volume question as wellthere?
Steve, I would say, for the given quarter our unit trendsboth in US and EU are pretty close to flat. I would reiterate one of the pointsI had made that we were comparing against a pretty strong quarter in Q3 '06.
Your next question comes from Mike King of Rodman &Renshaw.
Thank you for taking my question. Can you hear me? Rodman & Renshaw: Thank you for taking my question. Can you hear me?
I just wanted to see if you could -- maybe Bob could commentabout sort of -- where do you think you need to get in the TYSABRI relaunchwhere neurologists feel comfortable, to get that inflection that hockey stickthat everybody seems to be talking about but nobody seems to be able to puttheir finger on? Rodman & Renshaw: I just wanted to see if you could -- maybe Bob could commentabout sort of -- where do you think you need to get in the TYSABRI relaunchwhere neurologists feel comfortable, to get that inflection that hockey stickthat everybody seems to be talking about but nobody seems to be able to puttheir finger on?
Well, can I -- I am going to let Bob address part of thatbut let me take the first, which is -- our 100,000 projection does not assumesome big inflection, while a lot of people are talking about an inflection andone can imagine that occurring that is not what the assumption is as we buildto 100,000. So, you can get to the 100,000 number with some continued modestacceleration. So, increasing breadth and depth along the same lines that wehave seen in the US; andsimilarly increasing breadth and depth outside the US, as well as, the additionalimpact of new markets as those come online. And you sort of roll up all thatinformation and you will get to the 100,000. Relative to the inflection point, if you will, to the extentthat that’s -- that prescribing behavior is limited by fear of PML, theoutstanding question is, does the risk of PML accumulate with exposure toTYSABRI? I think the people that are worrying about that are looking kind of tothe two-year point where you have a sufficient number of patients that havebeen on continuously for two years to come to some kind of statisticalconclusion of whether the experience is going to be the same as the label,better than the label, worse than the label. That takes you out about this timenext year you will have a few thousand patients that have been well over twoyears. Bob, do you have any --?
No, I wouldn't add much to that, other than that we knowthere are 450,000 patients, more or less, being treated worldwide today. So ifyou look at the numbers and the growth in the market, again, we would notexpect to see a hockey stick, it is just the evolution of the increasingcountries, increasing prescribers, week-over-week, month-over-month,year-over-year.
Okay and just a quick follow-up. Do most centers that can doinfusions have a capability to do plasmapheresis as well or would that have tobe referred out? Rodman & Renshaw: Okay and just a quick follow-up. Do most centers that can doinfusions have a capability to do plasmapheresis as well or would that have tobe referred out?
I think all the major centers certainly would, beyond that Ithink we would have to do more looking at that situation.
Okay, thanks very much. Rodman & Renshaw: Okay, thanks very much.
Your next question comes from Michael Aberman of CreditSuisse.
A question on the RITUXAN change of control, the documentsare public, somewhat confusing, I just want to clarify, if Genentech exercisesthe option to select and to buy back, even if they lose that, does the otherparty get to buy back the CD20 or is it automatic -- the second and thirdgeneration or does it automatically switch to a royalty rate? And any idea asto clarity as to how much lower that royalty rate is than the profit share? Credit Suisse: A question on the RITUXAN change of control, the documentsare public, somewhat confusing, I just want to clarify, if Genentech exercisesthe option to select and to buy back, even if they lose that, does the otherparty get to buy back the CD20 or is it automatic -- the second and thirdgeneration or does it automatically switch to a royalty rate? And any idea asto clarity as to how much lower that royalty rate is than the profit share?
The answer is, the change of control, Genentech has theability to name a price for all the marketed CD20 products, at this point intime that only includes RITUXAN. The counterparty decides whether they are abuyer or a seller, the unmarketed products revert to a royalty and the rates onthat are undisclosed and unfortunately subject to confidentiality betweenGenentech and ourselves.
Okay. Taking the pattern here without Elizabeth on, can I follow up with a quickquestion on TYSABRI? There was some data on rebound, I know it was a small dataset, have you seen any patients come off TYSABRI and will we see further datain terms of what happens to the MRIs and disability when patients arediscontinued from TYSABRI? Credit Suisse: Okay. Taking the pattern here without Elizabeth on, can I follow up with a quickquestion on TYSABRI? There was some data on rebound, I know it was a small dataset, have you seen any patients come off TYSABRI and will we see further datain terms of what happens to the MRIs and disability when patients arediscontinued from TYSABRI?
Hi, this is Bob, again. From our clinical experience we havenot seen that and in our current practice in the commercial organization andtracking the patients we have not seen that to date. I guess, there has beensome anecdotal information but the plural of anecdote, a wise person said, isnot data. So we will have to -- but there is no evidence to date that we haveseen.
Will you be collecting that data in touch and presenting itat all at any point? Credit Suisse: Will you be collecting that data in touch and presenting itat all at any point?
Well, we collect all sorts of data, as you know, in [touch].What is relevant to the patient and physician community we will certainly sharein a transparent fashion, if we have any such information.
Okay, thanks, guys. Credit Suisse: Okay, thanks, guys.
Operator, I think we have time for one or two morequestions.
Okay. Your next question comes from Ian Somaiya of ThomasWeisel Partners.
Thanks for taking my question. Just a question onseasonality and -- as it relates to TYSABRI and AVONEX and whether it playedany roles in third quarter numbers? And is there anything unique to theEuropean reimbursement process which would lead to an increase in new patientstarts in the fourth quarter? Thomas Weisel Partners: Thanks for taking my question. Just a question onseasonality and -- as it relates to TYSABRI and AVONEX and whether it playedany roles in third quarter numbers? And is there anything unique to theEuropean reimbursement process which would lead to an increase in new patientstarts in the fourth quarter?
I will take about one, Ian. Seasonality, I mean, it is justthe fact that you see it in the summer, there's just fewer new starts, that hasalways been typical. It probably is more evident as the market growth overallslows down, you can see that more clearly through the data at least for youguys. You also see some softness in the starts once you get in and around theChristmas season, that is not a popular time for people to start new therapies.Sorry, Ian, what was the second part of your question?
On the European side -- Thomas Weisel Partners: On the European side --
The European reimbursement system, the only thing that isspecial there is that you're doing a country-by-country rollout and each one ofthese European markets has a different reimbursement system. You're typicallynegotiating with the government regulators and you need to establish areimbursement rate really before you can practically sell. That is why thesemarkets rollout over a period of 18 months because they all have a differentkind of process. So, for example, we really haven't seen the contribution inany significant degree of France,which is one of our major markets, Spain, which is a relatively newentrant. So, you will start to see some of these bigger markets start tocontribute patients here in the fourth quarter, in the tail end of the thirdquarter, that were not present in the first half of the year. So, it is notmore complicated than bringing on new countries one at a time.
All right, I guess my question related to more, what pharmaceuticalcompanies claim, which is in the fourth quarter they see a surge in salescoming out of Europe. So, I guess you are notexpecting that in the fourth quarter. Thomas Weisel Partners: All right, I guess my question related to more, what pharmaceuticalcompanies claim, which is in the fourth quarter they see a surge in salescoming out of Europe. So, I guess you are notexpecting that in the fourth quarter.
We have not -- that has not been a typical experience for usin the kind of markets we have been in.
Okay, thank you. Thomas Weisel Partners: Okay, thank you.
Your last question comes from Maged Shenouda of UBS.
Hi, thanks for taking my question. Can you outline yourdiscussions with Carl Icahn since you announced that you were putting thecompany up for sale? UBS: Hi, thanks for taking my question. Can you outline yourdiscussions with Carl Icahn since you announced that you were putting thecompany up for sale?
Okay. Just one follow-up then on the quarter, how should wethink about the R&D run rate? Is this quarter's spend a reasonable runrate? UBS: Okay. Just one follow-up then on the quarter, how should wethink about the R&D run rate? Is this quarter's spend a reasonable runrate?
I will give that to Paul.
Yes, I would say that it is very unusual with respect to theupfront for Cardiokine, so that was a big lump. If you take that out, we hadrun R&D at 29% of sales. I would say that that will come down as our sales numberscome up a bit. So there will be -- I think the run rate on a raw dollar basisis probably reflective, if you take the Cardiokine upfront payment out.
Okay, thank you. UBS: Okay, thank you.
Great, well, that was our last question. We thank you foryour participation in today's call. You may now disconnect.