Good afternoon. My name is Ashley, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Idec’s first quarter earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. (Operator Instructions)
Ms. Woo, you may begin your conference.
Welcome to Biogen Idec’s earnings conference call for the first quarter 2009. Before we begin, I’d encourage everyone to go to the Investor Relations section of our website, www.biogenidec.com and print out the press release and related financial table. You’ll find these are particularly helpful when our CFO, Paul Clancy reviews the financial results and the reconciliation to non-GAAP measures discussed today. We have also posted the slides on our website that outline the topics discussed on today’s call.
We’ll start with the Safe Harbor statement. Comments made in this conference call include forward-looking statements about our expected future results, including our 2009 financial guidance, our longer-term operational and financial goals, the sales potential of TYSABRI and other products and pipeline advancements.
These statements are subject to risks and uncertainties which could cause actual results to differ materially from expectations. You should carefully review the risks and uncertainties that are described in our earnings release, and in Item 1A of our most recent annual and quarterly reports filed with the SEC. We do not undertake any obligation to publicly update any forward-looking statements.
In addition, we have filed a preliminary proxy statement with the SEC for our 2009 annual meeting of stockholders. Before making any voting decision about our annual meeting proposals, you should carefully review our definitive proxy statement and related material, which will be available free of charge at our website or the SEC’s website.
On today’s call, I’m joined by Jim Mullen, CEO of Biogen Idec; Bill Sibold, Senior Vice President, U.S Commercial; Dr. Al Sandrock, Senior Vice President Neurology R&D; Paul Clancy, CFO and EVP Finance.
I’ll now turn the call over to Jim.
Thank you, Elizabeth. Good afternoon, everyone. The first quarter 2009 results were in line with our expectations, and consistent with full year 2009 guidance we provided in February.
Revenue grew 10% year-over-year to more than $1 billion. Non-GAAP earnings per share grew by 27%. In the face of a more challenging macro environment and foreign exchange unfavorability, we saw revenue growth of all three of our marketed products and signs of strengthening TYSABRI trends in the back end of the quarter.
We are controlling expenses aggressively, while at the same time investing in and advancing the pipeline that we highlighted at our R&D day in March. We have 20 programs in Phase II trials and beyond, and aim to have nine registrational programs ongoing by the end of the year.
Our marketed products posted strong business performance in the first quarter. Total revenues grew 10% year-over-year, and the franchises remain strong. AVONEX remains the global market leader, and success is driven by the long-term safety and efficacy profile.
The number of patients on TYSABRI continues to grow steadily. Approximately 2,400 patients were added in Q1 for a net total of 40,000 patients on therapy. We have reoriented the marketing and sales efforts in TYSABRI and are back to talking about the benefit risk profile. We have seen early signs of success in turning TYSABRI around.
Leading indicators have been positive in the second half of the quarter compared to the first half, the hopeful sign for continued strength and acceleration of patient additions as we move past the mid-year in January and early February and just this week, we received FDA approval for the high titer manufacturing process and that follows European approval for the process in December.
Revenue for RITUXAN and consolidated joint business grew 13% to over 279 million. RITUXAN is on track to achieve two additional indications. The first is the RA DMARD inadequate responder. The file was submitted last year with the summer 2009 PDUFA date.
Also the Image data announced in Q4 should strengthen the competitive profile for RITUXAN and RA. Secondly, we and our partners plan to expand the label in CLL by filing the CLL-8 and REACH data in both U.S. and Europe later this year. Bill Sibold, the SVP, U.S. Commercial will take you through an updated commercial franchises in a few moments.
As you have heard from other companies that have reported recently, the impact on the economic downturn is becoming more measurable and we’ve been monitoring the business closely. We face many of the same issues as others, but believe we have been buffered somewhat from the macro environment because of the severity of our diseases, that’s our products treat as well as the expansion of our global footprint in recent years.
With that said, we have seen signs of modest impact in our business from the downturn, such as increased requests for free and subsidized products and financial stress of a few of our supply chain partners. Paul, will provide a few details for you.
In the current environment we believe it is prudent to exercise some discipline and protect both the bottom line and the balance sheet, and we’ve been working successfully toward that end. Strategically, our pipeline is focused on first in class or best in class specialty products and diseases with high-end that need a global application. We presented many of our pipeline programs in great detail at our R&D day in March.
We provided unprecedented detail on some programs as well as access to people driving the pipeline forward. From the feedback we’ve heard, like many of you better understand the excitement we have for our pipeline, and those of you who attended witnessed firsthand the excitement and passion of our scientific leaders.
We’ll begin with some installed potential for the peginterferon to extend our AVONEX brand. We will have additional peginterferon data at AAN later this month. In a few minutes, Dr. Al Sandrock will highlight the neurology franchise and pipeline presentation that we will be making at the upcoming AAN meeting.
In addition to the positive feedback on R&D day, we recently received independent validation of the quality of our pipeline from Moody’s. Among 12 large U.S.-based pharmaceutical and biotech companies, Biogen Idec ranked highest on late-stage pipeline quality, and in the top third on pipeline diversity.
Finally, with respect to performance, our goal for 2007 to 2010 is to deliver 15 to 20 top and bottom line compounded annual growth rate. With five strong quarters in the books we are on track to achieve these financial goals.
We continue to expect 2009 non-GAAP earnings per share above $4, and we expect cash flow to exceed earnings. Three variables that may have impact on 2009 include the pace and timing of TYSABRI growth, the speed of advancement of late stage clinical trials, and the impact of the ongoing economic downturn.
In conclusion, the quarter turned out as we expected consistent with full-year 2009 guidance. We managed through some challenges and worked to deliver bottom-line performance and enhanced balance sheet. With strong franchises, cash flows, and balance sheet, we ended the quarter with approximately $2.5 billion in cash and marketable securities. We continue to focus on products pipeline and performance as the drivers of long-term shareholder value creation.
I’ll now turn the call over to Bill Sibold, the Head of the U.S. Commercial Business. Bill?
Thanks, Jim. In the first quarter our global neurology business delivered approximately $720 million in revenue. This is up 11% versus Q1 of 2008, driven primarily by the growth of TYSABRI over the last year.
AVONEX’s $555 million in global revenue in Q1 was up 4% year-over-year. This over $2 billion annual run rate reflects the strength of AVONEX’s market leading position with approximately 135,000 patients on therapy worldwide.
TYSABRI had end market revenue of $227 million in the first quarter, a 42% increase compared to the prior year, keeping it on a growth trajectory comparable to other biologics that became blockbusters such as Enbrel and Remicade.
As you can see from the press release, we continue to increase the number of patients on TYSABRI in the U.S. and internationally. We now have over 40,000 patients on commercial and clinical therapy and approximately 6,800 patients have been on therapy for over two years.
Now a little bit about AVONEX and TYSABRI in 2009. AVONEX will celebrate its 13th year on the market this year. We continue to be excited about the new data that is coming out about AVONEX. Specifically, I am referring to two significant studies.
First, the assurance data that was released at ECTRIMS showed that patients who remained on AVONEX for up to 15 years since the original pivotal trial had reduced disability progressions, greater quality of life, and significantly greater sense of independence and self-care versus those patients who had either switched to another therapy or discontinued therapy.
Second, data from the 10-year CHAMPIONS extension trial will be released at AAN later this month. This is the first trial looking at the long-term impact of treatment in early MS patients. AVONEX is the only product with this type of proven long-term efficacy which we know is very important in this market.
The combination of AVONEX’s proven efficacy and best-in-class compliance is why it is the number one MS therapy in the world. AVONEX disrupts the disease, not patients’ lives, and has demonstrated that it has the power to work early and keep patients active longer.
Turning to TYSABRI; as you may recall at the beginning of the year, I had said that we have three key objectives for TYSABRI in 2009. First, refocus communications on TYSABRI’s unprecedented efficacy. Second, help physicians increase their comfort in diagnosing and managing PML. Third, translate resulting improvement in TYSABRI’s benefit risk perception into increased and sustained use.
Progress against the first objective has been encouraging. The percent of MS-prescribing physicians who believe that the benefits of TYSABRI outweigh the risks has remained very high since December, and is in-line with pre-July 31, 2008, levels.
We believe that this is a result of our significant efforts and the expanding efficacy picture for TYSABRI. While the other MS therapies discuss efficacy in terms of decreasing relapses and slowing disabilities, TYSABRI has been able to demonstrate that in some patients the disease activity halts, and in other patients physical disability associated with MS improved.
On the second objective, through the early part of this year, we increased the level of education above PML and clinical vigilance to increase prescriber’s awareness and comfort in diagnosing and managing the disease.
We have also launched a number of other promotional initiatives to assist physician in discussing TYSABRI with their patients and to encourage patient to have open conversations about their therapy needs with their physician. We are looking forward to the upcoming AAN meeting where an update on TYSABRI safety and utilization will occur
With respect to TYSABRI trends, we continue to closely monitor international and TOUCH data to understand trends in TYSABRI prescribing patterns with obviously the most detail available for the U.S. As you are aware, there was moderation in patient growth in Q3 that was driven by both the slowdown in the rate of new patient ads as well as an increase in discontinuations and that trend stabilized in Q4.
Q1 appears consistent with Q4. However, in the last two months, February and March, we have seen further improvement in the trends for both new patient starts as well as discontinuations. We are optimistic that this trend will continue. The type of patients coming to TYSABRI appears to be unchanged based on both their times since diagnosis with MS and their prior therapy.
COPAXONE is still the largest source of switchers. Additionally, we continue to see about 4% to 5% of TYSABRI patients naive to therapy. We are actively engaging multiple channels to gain insight into the markets, feedback from our customers, and to promote TYSABRI. We create touch-points with not only physicians and patients, but also payers, regulators, and patient associations.
Specifically on the promotional front, we optimize our reaching frequency of messaging to physicians and patients. We do so through our sales force and patient services group, as well as numerous live peer-to-peer and patient programs, direct mail, and e-mail.
In conclusion, we remain excited about the remainder of the year and the future. The new data on AVONEX extend beyond that of any of its competitors in the ABCR market, and further reinforces that it is the right product to start with and stay with for the long-term. TYSABRI’s emerging efficacy profile continues to impress and reinforce its positioning, as the product for patients that need more efficacies.
Finally, our deep and broad MS pipeline positions us well to drive strong performance in the future. Nobody is doing more for MS than Biogen Idec. I will now hand the call to Dr. Al Sandrock, Senior Vice President, Neurology R&D. Al?
Thank you, Bill. As Jim noted, we provided a thorough update of our development pipeline less than a month ago at R&D day, and the slides are up on our website. On today’s call, I would like to highlight our activities at the upcoming American Academy of Neurology meeting, which will occur later this month in Seattle.
The AAN meeting is an important venue for us to exchange ideas and information with our neurology colleagues and interact with the MS community. There will be 25 company-sponsored platform and poster presentations at AAN, covering the five compounds that are marketed or in the later stages of development. These include AVONEX, TYSABRI, BG-12, PEGylated interferon beta-1a, and Daclizumab.
Biogen Idec is a leader in advancing therapeutics for multiple sclerosis and has already redefining success for patients living with MS. For example, with TYSABRI we are moving beyond slowing the progression of the disease. And as some patients may become free from disease activity or even experience reversal of physical disability during treatment. And if our preclinical experiments are any indication, we may one day even be able to repair the central nervous system that has been damaged by the disease.
The AAN will demonstrate that we have one of the most robust MS pipelines in the industry with drugs targeting the multiple biological pathways thought to be critical for disease onset and progression. To date, many of these programs have shown compelling results in clinical trials, and we look forward to their continued development.
One poster will show that Daclizumab, which was shown to reduce MS lesions visualized by MRI scans in the randomized double-blind, placebo-controlled Phase II CHOICE trial, appears to reduce T-cell activation during treatment.
There will be two BG-12 posters of the Congress, which will provide further evidence of a potential dual anti-inflammatory and neuroprotective mechanism of action for this oral therapy. I want to note here that during the quarter, we completed enrollment in the defined Phase III trial of BG-12, a trial with over 1200 patients randomized, the 200 clinical centers around the globe, and the second Phase III trial confirmed is expected to complete enrollment later this year.
There will be two company-sponsored posters on PEGylated interferon beta-1a at the AAN. One on safety and tolerability, and the other on the PK/PD profile of the drug as observed in the Phase I trials. These data support the advancement of the PEGylated interferon beta-1a into a registrational trial, which we expect to commence within a few months. This trial which will enroll over 1200 patients will test two subcutaneous dosing regimens, once every two weeks and once every four weeks.
As I have already noted, we will also be showing new data on our marketed products, AVONEX and TYSABRI at the AAN. There will be six company-sponsored posters and presentations on AVONEX, including one on the CHAMPIONS 10-year extension study, which followed patients for decade after starting AVONEX therapy just after the first demyelinating clinical event that heralded the onset of MS.
There will also be 14 company-sponsored TYSABRI posters and presentations in Seattle. Among these will be a poster on the post-talk analysis of the Phase III AFFIRM trial, which showed that a substantial proportion of patients realized an improvement of physical function, as measured by sustained decreases in EDSS over the course of the two-year trial. Another poster will show data that indicates that TYSABRI treatment may promote remyelination in MS patients, as assessed by novel imaging technique.
Finally, as we have been doing at the major neurology meetings, there will be a platform presentation that will provide updated TYSABRI safety and utilization information. All in all, we believe that our activities at AAN will highlight our extensive efforts in MS research and development and will underscore Biogen Idec’s commitment to improving the lives of patients living with MS.
With that, I’ll now hand it over to our CFO, Paul Clancy.
Thanks, Al. Our Q1 financial results were right on track with our business plan. We achieved 10% top line growth and 27% non-GAAP earnings per share growth on a year-over-year basis. The GAAP financials are provided in tables 1 and 2 of the earnings release. Table 3, you’ll find a reconciliation of GAAP to non-GAAP results.
Our GAAP diluted EPS was $0.84 in Q1. The primary differences between our GAAP and non-GAAP results for the quarter were 89 million related to the amortization of intangible assets, 7 million for pre-tax employee stock option expense, and 35 million tax impact related to these items.
Now I’ll move on to the non-GAAP P&L operating performance of Biogen Idec, which we believe better represents the ongoing economics of our business and reflects how we manage the business internally and set operational goals. Our non-GAAP diluted EPS was $1.05 for Q1. Q1 total revenue was 1.036 billion, representing a 10% growth over the same period last year.
Going through our product revenues, I’ll start with AVONEX. Q1 AVONEX worldwide product revenue was 555 million, representing 4% increase over the same period last year. Q1 U.S. AVONEX product revenue was 340 million, which represents a 10% increase over the same period last year.
On a sequential basis, U.S. AVONEX revenues were essentially flat as price increases offset a 4% unit decline. We had approximately one less shipping week in the quarter versus Q4, which was offset by inventory in the channel modestly up to 2.4 weeks. Q1 international AVONEX product revenues were $215 million, representing a decrease of 5% on a year-over-year basis. This decrease was primarily due to unfavorable foreign exchange, as the dollar to euro exchange rate strengthened from on average 151 in Q1 2008 to 131 in Q1 2009.
This FX movement had approximately $30 million impact to AVONEX international sales. Units were flat versus prior year as an increase in our direct markets was offset by a decline in our distributor markets. The decline in the distributor markets was attributed to our tender business.
Q1 TYSABRI worldwide Biogen Idec product sales were 165 million, a 44%increase versus Q1 2008. U.S. end user TYSABRI sales totaled $116 million, of which Biogen Idec booked $54 million of this amount. U.S. channel inventory ended modestly lower in Q4 2008. International end user TYSABRI sales totaled $111 million.
Before I move on to RITUXAN, I’d like to briefly touch on the current economic environment and its impact to the MS franchise. As Jim noted, MS is a severe disease and our business so far has been modestly impacted by the current economic downturn.
Our international business is somewhat buffered from the economic downturn in the short run, as most drugs are essentially reimbursed. Nevertheless, in the U.S. we have seen an increase in the number of patients, who are receiving free supply of TYSABRI and AVONEX.
We’ve also noticed the co-pay assistance has increased. Specifically, the number of patients on free drug has trended up very much in line with the U.S. unemployment rate. For the quarter, we estimate that this had approximately $6 million to $10 million impact on the top line. We’ll continue to monitor this on our business. It’s important also to note that foreign exchange impact on our product sales including what I had mentioned AVONEX international was approximately $40 million in total or 4% to our top line for the first quarter compared to prior year.
Now moving on to the RITUXAN collaboration revenues referred to as revenue from unconsolidated joint business. We recorded $279 million of revenue for the quarter, representing an increase of 13% on a year-over-year basis. Our RITUXAN revenues are broken into three components:
First, our share of the U.S. RITUXAN profits. Net U.S. RITUXAN sales were $642 million in the first quarter, up 6% versus prior year. And our Q1 profit share from that business was $180 million, up 14% versus prior year. The year-over-year increase benefited from price increases taken during 2008 and lower operating expenses in the collaboration.
Second, we received revenue on sales of rituximab outside the U.S. and in Q1 this was $84 million, up 10% versus prior year. And last, we were reimbursed $15 million for selling and development costs incurred related to RITUXAN. Q1 royalties were $24 million for the quarter. The decrease on a sequential basis was primarily due to the step down royalty tier on Angiomax.
Now turning to the expense lines in the P&L, which includes the non-GAAP adjustments that I described earlier, Q1cogs were $98 million or 9% of revenues. Cogs on a year-over-year basis modestly benefited from an expiration of a third-party royalty on AVONEX.
Q1 R&D expense was $275 million, which is approximately 26% of revenues. R&D expenses increased 8% on a year-over-year basis driven by our continued advancement of the pipeline. Included in Q1 were milestones paid to Aveo, the oncology antibody licensing agreement, and to Neuroimmune in the aggregate of $10 million.
Q1 SG&A expenses were $217 million, representing 21% of revenues and representing a 2% year-over-year increase. SG&A benefited from FX for the quarter as compared to prior year. Continuing down P&L are collaboration profit sharing line totaled $43 million in expense for the quarter. This represents our payment of 50% of profits on TYSABRI out the U.S. to Elan, and a reimbursement of third-party royalties incurred by Elan outside the United States.
Other income and expense for the quarter was a gain of approximately $7 million, which was $4 million favorable on a year-over-year basis. We ended the quarter with a strong cash marketable securities position of $2.5 billion generated interest income of $15 million, which was offset by interest expense of approximately $10 million.
We repurchased 1.2 million shares under our shares stabilization program in Q1. Our Q1 non-GAAP tax rate was approximately 24.5% much lower than our normal tax rate. The effective tax rate for the quarter was favorably impacted by a one time discreet item related to recently enacted state legislation. This will allow us to utilize certain R&D investment tax credits.
We expect our non-GAAP tax rate for the remaining quarters in 2009 to be between 28% and 30% and likely be at the lower end of this range for the full-year. This brings us to our Q1 non-GAAP diluted earnings per share of a $1.05 representing a 27% increase over the same period last year. We’re confirming our full-year 2009 guidance outlined in February. Top line growth in a high single digits, and non-GAAP earnings per share above $4.
Additionally I’d like to just add some perspective on cash flow. We’re also targeting to increase free cash flow growth over the rate of EPS growth. So our business plan is to achieve leverage from the top line to the earnings line, and further leverage in the free cash flow growth.
Q1 was a solid quarter for Biogen Idec. We’re increasing our efforts in educating the physician and patient community on the benefits of TYSABRI. We’re progressing and investing in our pipeline. Our EPS growth was impressive as we continued to exercise discipline, and we continue to generate significant operating cash flow and have a strong balance sheet.
I’ll turn the call over to Jim for his closing comments.
Thank you, Paul. In summary, business performance for the quarter was as expected in line with our full-year guidance. We continue to look for the best ways to maximize value for the shareholders whether through investment or returning cash to shareholders.
In our discussions with numerous shareholders, some see current asset values as buying opportunities while others see share buybacks as the best use of cash. We’re carefully evaluating both ends of that spectrum, as well as all of the options in between.
While we face some challenges in the remainder of 2009. I believe strong fundamentals of the business across all products and geographies will continue to deliver robust results and create significant value for our shareholders.
With that Elizabeth, let’s open it up for Q&A.
Great, thanks, Jim. Joining us on the call for the Q&A session is Dr. Cecil Pickett, our President of Research and Development. So Ashley, we’re ready to open up the call and we’d ask the participants on the call to limit themselves to one question and then re-enter the queue for follow-up questions to allow most people to get their questions in. And please state the name and company affiliation. So Ashley, we can take the first question now.
Our first question comes from Jason Kantor - RBC Capital Markets.
Jason Kantor - RBC Capital Markets
Could you be more specific exactly what are you tracking in the TYSABRI numbers that you’re saying you’re seeing an uptick in and what gives you confidence that these are getting better? And how sensitive are these leading metrics to, for example, another case of PML should it occur?
Sure. This is Jim. Why don’t I ask Paul to make a couple comments as well as Bill on that?
Well, our practice has been to provide the patient data on a quarterly basis. And we’ll kind of continue that pattern. So we won’t be giving detailed monthly or weekly data, but Bill can provide some additional color on the recent trends we’ve been seeing.
Thank you. Well, while the quarter as a whole saw steady patient growth, we saw signs of strength more recently and looking back over the last few months, we see that the December and January net patient ads were very soft, but we were moderately higher than that in the backend of the quarter.
More specifically, March was the highest month of net patient ads of the past five months in both the U.S. and in international. And in addition, we are seeing some hopeful signs from leading indicators such as TOUCH forms in the U.S., and finally discontinuations have started to return to pre-PML levels from what we can see.
So just to finish off the question, so the measurement is obviously more accurate in the U.S. where we have the TOUCH program than it is internationally, where it’s a little bit of triangulation.
Relative to the sensitivity to another case of PML, I think we’ve been through all that and not much has changed with the last couple of cases of PML. So, presuming that the rate stays more or less where it is, I don’t think there is a lot of sensitivity to a case or two of PML.
Our next question comes from Geoffrey Porges - Bernstein
Geoffrey Porges - Sanford Bernstein
Thanks very much for taking the question and just if I could follow-up with something that you mentioned on the call, I think you said there was one less shipping week in Q1 and Q4, and there was some changes in inventory that also affected you in Q1 versus Q4.
Could you give us a little bit more color on that and whether I misheard you or not? With that I think just talk us through what the actual changes in inventory were and also the shipping days Q-over-Q and year-over-year?
Yes. So Geoff, this is Paul. What I’ve referred to, you picked it up spot on. What I refer to is AVONEX. And, I think the way to think about it, there was an extra week in Q4 as opposed to Q1. We’re back to a normalized kind of quarter of essentially 13 weeks of shipping in Q1.
So, I think you just want to be mindful of that when you look at sequential, but not when you look at overlapping on a year-to-year basis. We have distributor relationships in the United States on AVONEX, and a couple of the relationships had asked for additional as they had changed their distribution locations, and asked for additional weeks in the channel.
As a result, AVONEX channel, weeks in the channel have moved up from roughly about 2.1 to roughly about 2.4 weeks in the channel for AVONEX. That’s a permanent change. So I don’t think you’ll see that wiggle and waggle around over the next couple of quarters. And then, to some extent that increase was offset by, we actually saw a decline a little bit on the TYSABRI business.
Our next question comes from Michael Aberman - Credit Suisse.
Michael Aberman - Credit Suisse
I have a question about TYSABRI. I start off with that but haven’t got to do the math. It looks like you’ve had another sequential increase in patient numbers and a 3% price increase at the end of fourth quarter, yet the end user sales aren’t up enough to really account for that.
Even looking back, third quarter and fourth quarter, you had a similar situation with the number of patient’s net ads increasing, but the actual revenue not tracking with that. Can you help me understand, what’s happening there in terms of doses per quarter and how that might be playing a role in the revenue, and you think that’s going to change?
Yes. This is Paul. Michael thanks for the question. I think this provide two dynamics that we are looking at and pointing to. One is kind of this in essence the macro trend and the increase in free goods, if you will and as a result of the patients for both AVONEX and TYSABRI. That is certainly pronounced in TYSABRI given the uptick curve.
Then the other trend that we’re seeing is a very modest decline on a quarter-to-quarter basis in terms of infusions per patients over the course of a quarter. It’s not anything that we see as alarming. We saw this actually early in the AVONEX days, in the launch days years ago. So I think it’s nothing that we see alarming. Obviously, you know people are mindful of thinking about it as drug holiday, but we certainly aren’t pointing towards that way in regard.
Our next question comes from Geoff Meacham – JP Morgan.
Geoff Meacham – JP Morgan
I just want to ask a question here, sort of bigger picture on TYSABRI. You know as you guys accumulate PML cases over the next few years, how do you see it playing out commercially? Do you think docs will look the common features such as duration of therapy or baseline disability to manage patients, and how will that kind of work you think in practice?
Yes, this is Bill. You know, I think as we look at the evolving landscape, if you look into the pipelines of any of the products which are going to be launching in the coming years, there each certainly appears to have its own benefit and risk profile associated with it.
Part of what we are seeing is we expect that the neurology community will evolve in its approach to benefit risk as they have more products to that they have to make that evaluation; just to draw a comparison to rheumatology, where you’ve got, three blockbuster anti-TNFs. For years before the TNF launched, rheumatologists had the opportunity to get comfortable with benefit-risk with methotrexate.
You can see also that TYSABRI tracking in the period post-launch very well with those products. So, we think that there’s going to be kind of an evolution of the specialty feeling more comfortable with benefit-risk. And I think certainly with PML, they will become more comfortable with that. And, certainly it will depend upon what happens from here and what the outcomes of the cases are.
Our next question comes from May-Kin Ho - Goldman Sachs.
May-Kin Ho - Goldman Sachs
Can you just talk a little bit about AVONEX in terms of reimbursement or insurance coverage? How many percent of the patients have commercial insurance? How much of that is pharmacy benefit? What kind of tier it is?
I heard you mentioned that there is some in essence drug holidays for TYSABRI patients, which you saw before, but we all know that the current economic condition is quite different than what we saw previously. So, do you expect to have more patients basically stretching all the time, maybe thinking what drug holidays and I do see delays in patient starts because of the economic conditions?
May-Kin, we’re going to forget all of the questions that were embedded in it, but you did it in one sentence though, we’ll give you credit. Let me start with the last one because I think Bill is actually trying to see if he can dig out some of the perplexed data that you asked for on the first.
We are seeing patient requests for free goods or subsidized goods, track more or less with our employment. You can probably infer some of that into people thinking about how to stretch their budgets, too. So you might see a little bit more of that stretch out as we go through and bottom out here on employment numbers.
It’s very hard to predict, but we can see a few percent impact on the business there. In terms of some of the other questions, Bill, do you have the directional answers, or are we going to have to….
Yes. We can get a little bit more specific, but to start off with, AVONEX is in a very favorable position from a reimbursement perspective. In most of the plans, it enjoys just very good positioning, and we have seen that not be a barrier to getting use of the product.
The vast majority of the patients have a fixed co-pay along the lines of $20 to $30 a month. And a small number have co-insurance which would be typically in that 20% cost. So it is covered under pharmacy benefit, it has got great positioning, and we feel very comfortable with AVONEX.
Our next question comes from Joel Sendek - Lazard.
Joel Sendek - Lazard
I have a question about the high titer process. Will that have any kind of material impact on the gross margin, and if so, when?
Yes, Joel. The answer is it will have an impact on the gross margin. You’re not really going to see much of that this year as we work through the various stages of inventory we have and as you can probably appreciate, we have got to build some inventory here before we want to move that one into the market, as well. I don’t really think you’re going to see much of it this year.
When you look at the gross margin, we will get some pick up there, but a lot of what’s in the gross margin are third party royalty payments to other people. So that’s a pretty good chunk of what’s in our cost of goods now. So a little pick up, but I think of it as a percent or two maybe.
Joel, this is Paul. I just add the way it comes. I think Jim talked about that as it relates to kind of from a TYSABRI collaboration point of view. The way it comes into our P&L is slightly different than just kind of a normal into the gross margin or cost of goods line. Most pointedly would be in the U.S. and the purchase price economic.
Our next question comes from Jim Birchenough - Barclays Capital.
Jim Birchenough – Barclays Capital
I am just trying to understand better the impact of your education program around PML risk, and with better surveillance we’ve seen better outcomes, but I’m just wondering what the result of that has been in terms of suspected cases coming to you guys. Are you seeing physicians, more an expert at teasing out what’s a real high risk for PML case or are you seeing just a lower sensitivity to suspected cases being reported to you guys? Just wondering what trend we’re seeing there?
Yes. I think what we’re seeing is that patients are being picked up earlier. I don’t think that we’re getting a big change in terms of suspected cases. What we’re seeing is earlier recognition and earlier use of some of the tools that we’ve provided in terms of managing the cases.
Our next question comes from Yaron Werber - Citi.
Yaron Werber - Citi
I have two questions for you. One, can you just help us understand a little bit the TYSABRI draw down in inventory that happened in Q4? I don’t know if you can quantify that in days or in millions.
Then the second question, just help us understand the tax rate a little bit more. I’m sorry if I missed why it was so low in the quarter, and you’re guiding it sounds like to the lower end of your range. So help us understand how would the tax rate slowly ramp up in the year?
Yes. So let’s take the first one, TYSABRI. What I had referenced was Q1 versus Q4, so not that it was drawn down in Fourth quarter; just the quarter-to-quarter change on weeks of inventory in the United States is modestly down. And we’re talking in the less than a week and so half a week type of down on weeks in channel.
In terms of the tax rate, we benefited from a discreet item a one time. There was a change in state legislation tax law. We set up what we call FIN 48 reserves. We set up reserves over the long haul as it relates to our taxes, and embedded in those reserves is legislation. The legislation change which gives us high probability and certainty that we will be able to capture reserves for a number of the years in certain states, that’s a one-time benefit, it’s not sustainable.
So all I was pointing to in terms for the balance year is that we drive back up to our normal rate. Without that discreet item, when you combine three quarters of a normal rate with one quarter with a kind of depressed rate, it’s likely at the lower end of the tax range.
Basically, allows us to capture some R&D tax credits that were otherwise hung up.
Our next question comes from Eric Schmidt - Cowen & Co.
Eric Schmidt - Cowen & Co.
A couple financial questions for Paul; first is the gross margin in Q1 a real number that we can use going forward for the year? Second, your EPS guidance remains kind of open ended for 2009. Do you expect to grow the bottom line over the subsequent three quarters?
So gross margin is what we are looking at now is probably indicative of the balance of the year plus or minus. In terms of earnings per share, I go back to Jim’s point in opening; the kind of three big variables will be rate of uptick on TYSABRI. The macro environment that, we are not terribly concerned about, don’t want to kind of get that point across, but we’re being mindful about, and then the rate of acceleration of the R&D business.
We had a good quarter on the bottom line this quarter. I mean, you can all do the math. Obviously, we want to grow the earnings for the balance of the year. But we just want to try to make sure that we’re still definitely being able to achieve our full year earnings per share target.
Our next question comes from Mark Schoenebaum - Deutsche Bank.
Mark Schoenebaum - Deutsche Bank
Okay, on TYSABRI, should we model the dollars per patient calculation that this quarter’s results would spit out. You said you weren’t alarmed by the misconfusions, but what I’m trying to understand is this a run rate that we should use going forward in our models when we think about modeling TYSABRI revenue from our patient add calculation? Then just to be clear for this one less shipping week was that only for AVONEX or did that also apply to TYSABRI?
Let me take in the reverse. It actually also applied to TYSABRI, and then with respect to TYSABRI, and keep in mind, I think it’s twofold of what’s going on including the impact of, additional pre-patients in the TYSABRI business. So, that one for me is, likely harder to predict and who knows, it could go up or could come right back down, but both of those effects are affecting the revenue per patient on the TYSABRI business, but absent that, that dynamic, it’s probably not a bad thing to model.
Our next question comes from Jason Zhang - BMO Capital Markets.
Jason Zhang - BMO Capital Markets
Thanks. The question is on the economic impact you mentioned that patients on free drug are increased. There are also more patients probably need to get co-pay assistance. I’m wondering for co-pay assistance, how is that affecting revenue? Is that because of delayed of reimbursement or delayed infusion? How is that?
Actually you gave us number about free drugs, the impact that could be in the $6 million to $10 million. Can you actually quantify the impact of co-pay assistance? Also, whether you think this is going to get worse or you think this is mostly going to be a Q1 phenomenon?
So, this is Bill. With co-pay assistance, that’s something which actually is programmed which were for AVONEX launch last year and TYSABRI really this year. We certainly have made provisions in planning, thinking that it’s going to be a program that will be utilized this year and so far, we’re still in the early stages of it and the feedback has been very positive. We’ll continue to track it as the quarters go on and compare it to the economic environment.
Our next question comes from Maged Shenouda - UBS.
Maged Shenouda - UBS
How much more pricing leverage do you think you have for AVONEX, and also should we start thinking about aggressive price increases for TYSABRI?
Magi, we actually don’t comment on our forward-looking pricing. So best thing I can share with you is that we don’t build it into our business plans, the price increases that we’ve seen.
On the TYSABRI, keep in mind that one is going to be ASP plus six kind of pricing, so you really have to be careful about pricing increases there, the frequency and the amount or you can put the physicians under water.
(Operator Instructions) Your next question comes from Chris Raymond - Robert W. Baird.
Chris Raymond - Robert W. Baird
I know you guys have answered this question on prior conference calls, but can you walk through actually the mechanism. I think you mentioned before you have some natural hedge of sorts, against FX fluctuations. But you mentioned $30 million of AVONEX FX impact. Could you maybe also reiterate what the TYSABRI FX impact was and then also maybe describe what that hedge is, thanks.
Yes, okay. So in total it was about $40 million as that was $30 million for AVONEX international, the balance of $10 million or $11 million for TYSABRI international was the impact on a quarter 2009 versus quarter 2008 essentially going from 1 51 on average U.S. to Euro to 1.31 in average in Q1, 2009.
Generally speaking we hedge the annual plan. We generally do that as we get conclusion on our annual plan. So it’s usually late in one year will go out in hedge, the following year and we buy contracts that essentially try to hedge the cash flow impact to the business.
So it wouldn’t hedge of the natural hedge. The natural hedge that we have is essentially our sales in marketing, in G&A, infrastructure that’s in Europe and other parts of the world in some modest amount of our R&D business. The impact in 2009 versus Q1 2008 that we benefited was roughly less than half of the amount that was detrimental to us on a quarter-to-quarter basis on the top-line.
So, in essence we picked up price $15 million or $17 million on a quarter-to-quarter basis in operating expenses. As a result, the difference between the two is what? From an earnings per share that $0.04, $0.03 or $0.04 is what the impact was on a quarter-to-quarter basis earnings per share.
All of the hedge gains and losses are netted against the AVONEX international business. So, there are quarters where we have a hedge gain. If we had locked in numbers that were above or below and vice-versa that we have hedge losses. In Q1 2009, it was essentially de minimis. Hope that helps.
Your next question comes from Michael Aberman - Credit Suisse.
Michael Aberman - Credit Suisse
I have a housekeeping question on the other income, and maybe this has already been addressed, but you had some losses over the past few quarters.
Michael Aberman - Credit Suisse
Do you have any benefit this quarter, can you explain to us where that’s coming from. What we should expect going forward? What’s happening there?
Yes. I think the run-rate that we saw in this quarter is a little bit high. And it was a $7 million benefit OIE. I would expect that to be down a little bit for Q2, 3, and 4 and not because of any meaningful write-offs, just because we picked up a little bit on some stuff that’s outside of interest income and interest expense, just a couple million dollars.
Our portfolio is in a very conservative position right now. Of $2.5 billion of cash and marketable securities, close to 85% of that is in government agency backed or cash and money market accounts. We are now down at the end of the first quarter to $22 million in non-agency mortgage backed securities and have a commitment to our company and our board to kind of get out of that in an orderly fashion.
So, what we saw in the back half of the year we are hopeful that we won’t see anything of any kind of meaningful difference going forward. The only caution I point out is that we do have strategic investments in public and private biotech companies that we do for strategic reasons and those can ebb and flow over the course of multiple years.
Your next question comes from Geoff Meacham – JP Morgan.
Geoff Meacham – JP Morgan
The question for you on TYSABRI, when you guys give the net ads, obviously it new starts minus discontinuations and I’m wondering, how you classify discontinuation versus a simple dose skip. Is there a certain amount of doses that a patient must be charged against the net add number?
Geoff Meacham – JP Morgan
Did I stop you guys?
Yes, we got it.
Yes and this is again very specific to the U.S. with TOUCH, because we have obviously greater insight with the data we received through that program. If a patient has missed a certain number of days from their expected infusion at the 30-day mark where we would expect them, if it extends out beyond that to beyond 45, 60 days and beyond, we start to classify that as a potential that they aren’t coming back.
What we do, though, is that through the TOUCH program, we do reach out and we look for confirmation and a discontinuation form is actually sent in. And that is truly what we ultimately measure.
Jeff, I’d just add we also kind of triangulate on the question you’re asking. But we also look at the average time of the whole patient database between doses. And that has not sub shown a meaningful change. So that would show a meaningful change, if we’ve got patients in our database that really aren’t patients anymore I think is what you get in that.
On the international front, we use a combination of patient registries where we can get them and then looking at shipping data into physicians where we obviously have it, and build our patient database and our patient expectations based on that. That actually as a result winds very much up with shipments. So, it’s not going to be suspect to kind of this type of issue that we’re talking about.
Your next question comes from Mark Schoenebaum - Deutsche Bank.
Mark Schoenebaum - Deutsche Bank
On Europe, the ex-U.S. AVONEX number, a little below consensus and you mentioned the effects. I am just wondering now if you could comment on price. Novartis launched a new version of an old beta interferon over there. Has there been any change in net price across the big European markets?
No. In fact Mark, we’ve actually seen the price advances in Germany, and we’ve managed over the last, let’s probably call it 18 months to realize price advances from trying to control some parallel trade between a couple of the countries.
Now over the next couple of years, I’d say that we’re watching it as each country, in different times, in different stages actually comes up for renewal on the reimbursement front. So, we are watching that.
Related to the competitive threat of Extavia, we have our ear to the ground. Sales people are very focused on it, but it has not had a meaningful impact yet.
Your next question comes from May-Kin Ho - Goldman Sachs.
May-Kin Ho - Goldman Sachs
I don’t know whether I heard correctly, did you say that you are actually going to file the FDA application on lumiliximab?
No, we were talking about REACH and CLL-8, for RITUXAN.
Your final question comes from Yaron Werber - Citi.
Yaron Werber - Citi
Yes, hi. You’ve talked over time to show operating leverage, help us understand a little bit the SG&A line? I mean, what I understand, your business pretty much is fully scaled up from an expense perspective, so you can just lever that up from now on. So can you just help us understand how is that going to flow over on a quarterly progression sort of showing synergies there or showing improvements there? I’m referring to the SG&A spending.
Yes. This is Jim. So the SG&A spending, we expect to get some modest leverage on that of course, as the sales increase. I think the caution on that, of course, is we also have to be very careful that we may maintain a strong competitive position on share of voice, because we know share of voice moves market around overtime.
So sometimes we’ll be doing some modest adjustments to the resource levels, as we look to just to meet whatever the new competitive framework might be. But, we would seem to get modest leverage there overtime. I wouldn’t expect to see dramatic leverage though. I guess is what I would say. Paul, do you have…
Well, thank you everyone. It was nice to be able to take so many questions on the call today, and we’ll see you on our next earnings call. Thank you.
This concludes today’s conference call. You may now disconnect.
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