Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`Q4 2011 Earnings Call
`
`Company Participants
`
`, SVP CommercialBob Terifay
`
`Leonard Schleifer
`, Founder, President, CEO
`Michael Aberman
`, VP
`, CFO
`Murray Goldberg
`
`FINAL
`
`Other Participants
`
`, AnalystBiren Amin
`
`, AnalystChris Raymond
`
`
`, AnalystGeoff Meacham
`, Analyst
`Jason Kantor
`Jim Birchenough
`, Analyst
`, AnalystJosh Schimmer
`
`, Analyst
`Phil Nadeau
`, AnalystSteve Byrne
`
`Unidentified Participant
`, AnalystYaron Werber
`
`
`Presentation
`
`Operator
`
`Good morning, ladies and gentlemen, welcome to the Regeneron Pharmaceuticals
`conference call to discuss the Fourth Quarter and full year 2011 financial results. My name
`is LaToya and I'll be your coordinator today. At this time, all participants are in a listen-only
`mode. We will conduct a question-and-answer session towards the end of the call. As a
`reminder, this call is being recorded for replay purposes.
`
`I would now like turn the call over to Dr. Aberman, Vice President of Strategy and Investor
`Relations for Regeneron. Please proceed Dr. Aberman.
`
`Michael Aberman
`
`{BIO 6989908 <GO>}
`
`Thank you, very much. Good morning, and welcome to Regeneron Pharmaceuticals
`Fourth Quarter and full year 2011 conference call. An archive of this webcast will be
`available on our website under events and presentations for 30 days. Joining me on the
`call today is Dr. Leonard Schleifer, Founder, President and Chief Executive Officer, Murray
`Goldberg, Chief Financial Officer, and Robert Terifay, Senior Vice President of
`Commercial. After our prepared remarks, we will open the call for questions and answers.
`
`Page 1 of 16
`
`Bloomberg Transcript
`
`Exhibit 2133
`Page 01 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`I would like to also remind you that remarks made on this call that are not historical nature
`may be forward-looking statements about Regeneron and are subject to a number of risks
`and uncertainties. Actual events and our actual results may differ materially. Such remarks
`may include, but are not limited to, those related to Regeneron and its products and
`business, sales forecast, development programs, collaborations, finances, regulatory
`matters, intellectual property and competition, all of which involve a number of risks and
`uncertainties.
`
`A more complete description of these and other material risks can be found in
`Regeneron's filings with the United States Security and Exchange Commission including
`its Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter ended
`September 30, 2011. Regeneron does not undertake any obligation to update publicly any
`forward-looking statement whether as a result of new information, future events or
`otherwise unless required by law.
`
`GAAP and non-GAAP measures will be discussed on today's call. Information regarding
`our use of non-GAAP financial measures and a reconciliation of these measures to GAAP
`is available in our financial results press release which can be accessed on our website.
`Once our call concludes, the IR team will be available to answer further questions. With
`that, let me turn it over to our President and Chief Executive Officer, Dr. Len Schleifer.
`
`Leonard Schleifer
`
`{BIO 1463677 <GO>}
`
`Thank you, Michael, and good morning to everyone. I apologize in advance, I have a cold
`and a cough and there's been nothing coming from the labs to deal with it. I want to state
`that this is our very First Quarterly conference call, some of you may say it's about time,
`but we think now it's time we start as we transform ourselves into a commercial Company
`to start having these calls.
`
`2011 was truly a transformational year for us. It was the year when we advanced our vision
`of becoming not only a fully integrated biopharmaceutical Company, or FIBPCO, but also
`hopefully a long-term biopharmaceutical growth Company. We submitted three BLAs in
`the US and celebrated the approval and launch of a potentially major product EYLEA.
`
`We also reported positive Phase 2 results with two antibodies in our collaboration with
`Sanofi which are now in Phase 3 testing. In a survey conducted by the General Science,
`we were voted the second best biopharmaceutical Company to work for.
`
`As we look forward to 2012, we see another exciting year ahead of us with the continued
`launch of EYLEA for wet AMD in the US and the potential for FDA approval for our
`products or product candidates in three new indications, EYLEA for central retinal vein
`occlusion, ZALTRAP for previously treated metastatic colorectal cancer and ARCALYST for
`the prevention of gout flares. Beyond the US, we see potential approvals and launches
`across the globe for both EYLEA and ZALTRAP with our partners Bayer HealthCare and
`Sanofi.
`
`FINAL
`
`Bloomberg Transcript
`
`Page 2 of 16
`
`Exhibit 2133
`Page 02 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`Turning to the launch of EYLEA for wet AMD in the US, we are pleased to report that the
`launch continues to go extraordinarily well and exceeds our expectations on many fronts.
`Only a relatively short time ago, in early January, we reported that our Fourth Quarter 2011
`EYLEA sales where $24.8 million which was many fold higher than most analysts were
`predicting for the six weeks of sales at that time. We also provided a preliminary forecast
`for 2012 EYLEA US sales of $140 million to $160 million. As we said back then, this forecast
`was based on only six weeks of sales data.
`
`With another six weeks of EYLEA sales results, we have some added confidence in the
`EYLEA sales trends. In the first six weeks of 2012 we have seen an increase in weekly
`demand from a large number of doctors and practices, good repeat ordering trends,
`favorable reimbursement trends and positive feedback from physicians.
`
`FINAL
`
`In fact, we have now shipped over 30,000 vials to physicians offices since our launch in
`November. As a result, we are increasing our 2012 EYLEA net sales forecast from $140
`million to $160 million up to $250 million to $300 million. To be clear, while we have an
`additional six weeks of information, the launch is still early and therefore there is
`significant uncertainty inherent in this forecast.
`
`The benefit of less than monthly dosing with efficacy that is clinically equivalent to
`monthly ranibizumab appears to have resonated strongly with the AMD community, as
`has our pricing. We believe that EYLEA with it's less frequent dosing offers an attractive
`new treatment option that provides an important alternative to wet AMD patients and
`physicians.
`
`With over 30,000 vials shipped to physicians, we are also gathering our post-market
`safety data to follow up our first post marketing safety report with the FDA. In doing that,
`we can report that there have been no new adverse events not seen in our clinical trials,
`described in our label or that were inconsistent with the known risks of intravitreal
`injection.
`
`As many of you know, intravitreal injections with anti-VEGF therapy are associated with
`known complications particularly ocular complications such as endophthalmitis and
`retinal detachments. Posted injection intraocular inflammation, such as sterile
`endophthalmitis, is a known risk following intravitreal injections of anti-VEGF agents and
`triamcinolone, incidence rates that report in the literature and can vary from 0.2% to 0.3%,
`and has also been reported to occur in clusters.
`
`There have been approximately 14 cases of adverse events consistent with sterile
`endophthalmitis and a single isolated case of culture positive endophthalmitis reported to
`Regeneron with the use of EYLEA since launch. This translates to a rate of 0.05% per
`injection, similar to that which was seen in our clinical trials and within the range that has
`been reported with other anti-VEGF agents.
`
`Bloomberg Transcript
`
`11 out of the 14 cases of sterile endophthalmitis were reported by a single group practice
`of six retinal specialists, and 9 of these 11 cases were accounted for by a single physician
`within the practice. The cases could not be traced to a single lot of drug nor a single
`
`Page 3 of 16
`
`Exhibit 2133
`Page 03 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`delivery of commercial vials. Vials from the same lot have been used widely throughout
`the country including the other physicians in this practice.
`
`Excluding this one practice, the rate of intraocular inflammation reported to Regeneron
`following EYLEA was approximately 0.01% or 1 in 10,000. We're working closely with the
`practice involved to better understand this cluster, and are in the process of
`disassembling the information we have learned to retinal physicians. We have informed
`the FDA, as per than normal course. To be clear, we do not believe that the data available
`indicate that EYLEA is responsible for this cluster.
`
`In terms of reimbursement, the comprehensive program that we have rolled out including
`EYLEA for you and extended commercial terms have been very well received. We have
`now received reports of reimbursement from all of the regional Medicare administrative
`contractors, giving us confidence that payers do understand the importance of EYLEA as
`an option for patients with wet AMD.
`
`We have also seen positive responses and reimbursement from many of the commercial
`payers. This is not to say that we don't have more work to do and do not face continued
`reimbursement hurdles until we receive a permit J-code, which is expected in January
`2013.
`
`While EYLEA and wet AMD is the focus in the near term, we view EYLEA as a pipeline
`within a product, and are working diligently towards advancing EYLEA in other
`indications, namely central retinal vein occlusion, where have filed a supplementary BLA
`and have been granted a PDUFA date of September 23, and diabetic macular edema,
`where we have two Phase 3 studies that are ongoing, one of which the US study is fully
`enrolled. We plan on initiating shortly a Phase 3 study in branched retinal vein occlusion.
`
`Our ex-US collaborator Bayer HealthCare has submitted regulatory applications for EYLEA
`and in wet AMD in Europe, Japan and other countries, and we expect approval in these
`territories beginning the second half of this year. Bayer has also started a Phase 3 trial in
`wet AMD in China in the Fourth Quarter of 2011. We believe that this is an important
`market as evidenced by the fact that in 2010 there were approximately 540,000 newly
`diagnosed wet AMD patients over the age of 50 in China.
`
`EYLEA is both a driver-- EYLEA is a driver both near term and long term value to the
`Company and shareholders, but Regeneron is more than just about EYLEA. We firmly
`believe that we have the key elements that are fundamental to achieving sustained long-
`term growth namely near and long-term revenue drivers, a pathway to profitability that is
`driven by the profit margins of our products and product candidates, an the attractive
`terms of our collaboration agreements, a wide, strong and rapidly advancing pipeline,
`and our solid infrastructure of people and manufacturing capabilities.
`
`Our commitment to transform science into medicine is reflected in our robust and rapidly
`advancing pipeline. In 2011, we filed a supplemental BLA for ARCALYST for prevention of
`gout flares in patients initiating uric acid-lowering therapies and have been granted a
`PDUFA date of July 30 of this year. We also initiated UPSURGE, a long-term safety study of
`
`FINAL
`
`Bloomberg Transcript
`
`Page 4 of 16
`
`Exhibit 2133
`Page 04 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`ARCALYST. We along with our partner Sanofi have submitted a BLA for ZALTRAP for
`previously treated metastatic colorectal cancer for which we expect the regulatory
`decision in 2012. Sanofi has also filed a marketing application for ZALTRAP in the EU.
`
`We also reported positive Phase 2 data from late stage-- two late stage antibodies in our
`pipeline, PCFK9 in hypercholesterolemia and Sarilumab, our IL-6 receptor in rheumatoid
`arthritis and have advanced two new antibodies into the clinic. Both the PCSK9 and the
`Sarilumab programs are continuing to advance to Phase 3 this year. Both programs
`address significant market opportunities. We look forward to presenting results from two
`of the Phase 2 PCSK9 trials at the upcoming American College of Cardiology meeting
`where one of the trials will be presented in the late breaker session.
`
`FINAL
`
`Our pipeline now has a total of 10 antibodies in the clinic, 8 of which are being developed
`in collaboration with Sanofi. At Regeneron, we've always believed that good science wins
`out and the approval of EYLEA was proof of the validity of this belief. We are well
`positioned to continue to make important advances in therapeutic areas where there is
`unmet need and significant commercial opportunity. With that, I would like to now turn
`the call over to Murray Goldberg, our Chief Financial Officer, who will review our Fourth
`Quarter and full year financial results.
`
`Murray Goldberg
`
`{BIO 1463711 <GO>}
`
`Thank you, Len, and good morning to everyone. This morning we reported total revenues
`in 2011 of about $446 million for the full year and $123 million for the Fourth Quarter. In
`the Fourth Quarter, this includes net product sales of $24.8 million for EYLEA and $5
`million for ARCALYST. Our gross to net adjustment for EYLEA was 7.3%. Cost of goods
`sold in the Fourth Quarter was $3 million, or about 10% of net product sales.
`
`This includes an accrual for royalties payable to Genentech under the license and partial
`settlement agreement that we signed in December relating to ophthalmic sales of EYLEA
`in the United States. From a cash perspective, we're not obligated to make any payments
`to Genentech until cumulative US sales reach $400 million. Then we'll make a one-time
`payment of $60 million.
`
`Thereafter, we'll pay royalties until May 7 of 2016 of 4.75% on cumulative sales between
`$400 million and $3 billion and 5.5% on cumulative sales over $3 billion. In terms of
`accounting for these payments, we are accruing royalty expense as we recognize sales of
`EYLEA using a blended mid single-digit royalty rate that reflects both the $60 million
`payment and royalty obligations based on our estimate of cumulative sales through May 7,
`2016.
`
`Non-GAAP research and development expenses rose 6.4% in 2011 to about $497 million,
`principally in connection with our Sanofi antibody collaboration. Non-GAAP SG&A
`expenses doubled in 2011 to $94 million, primarily related to the commercialization of
`EYLEA. We expect further increases in SG&A expenses in 2012 as we prepare for the
`launch of ARCALYST for the treatment of gout flares. Non-GAAP R&D and SG&A expenses
`exclude non-cash share-based compensation expense.
`
`Bloomberg Transcript
`
`Page 5 of 16
`
`Exhibit 2133
`Page 05 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`We reported and non-GAAP net loss of $34 million, or $0.37 per share for the Fourth
`Quarter, and a non-GAAP net loss of $161.7 million, or $1.79 per share for the full year 2011.
`Non-GAAP net loss excludes non-cash share-based compensation expense and non-cash
`interest expense related to our convertible senior notes.
`
`For the Fourth Quarter we reported a GAAP net loss of $53.4 million, or $0.58 per share.
`For the full year 2011, we reported a GAAP net loss of $221.8 million, or $2.45 per share,
`compared to a net loss of $104.5 million, or $1.26 per share for the full year 2010. All of
`these per share values are for both basic and diluted per share calculations.
`
`In October 2011, we completed a private offering of $400 million aggregate principal
`amount of 1.875% convertible senior notes. Following this, we ended 2011 with
`approximately $811 million in cash and securities. We believe that financially we're in a
`comfortable position to support the required investment not only for the continued
`commercial launch of EYLEA but also for the launch of ARCALYST in gout and ZALTRAP in
`colorectal cancer, as well as for advancing our pipeline and driving us toward profitability.
`
`In terms of financial guidance as you heard from Len, we're updating our EYLEA net sales
`forecast from the previous $140 million to $160 million to a new range of $250 million to
`$300 million. We continue to expect COGS for EYLEA, including royalty expense, to be
`under 10% of net sales. Thank you, and with that, I will turn the call back to Michael.
`
`Michael Aberman
`
`{BIO 6989908 <GO>}
`
`Thank you, Murray, and thank you, Len. That concludes our prepared remarks, we'd now
`like to open the call for Q&A. As we'd like to give as many people a chance to ask a
`question as possible, we request you limit yourself to one question and our team will be
`available in our office after the call for follow-up questions. Thank you, and Operator, can
`you please give instructions and open the call for questions?
`
`Questions And Answers
`
`Operator
`
`(Operator Instructions) Jim Birchenough of BMO Capital.
`
`Q - Jim Birchenough
`{BIO 5068439 <GO>}
`Hi, guys, congratulations on the strong launch. I just wanted to follow up on the sterile
`endophthalmitis clustering at that one center. Is there any working hypothesis and what
`might be underlying that and I'm interested in particular if whether these cases were in
`treatment naive patients or in switch patients and maybe just a bit more detail on that
`would be helpful? Thanks.
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`Thanks, Jim. What we know so-- there's no firm hypothesis at this point. We're looking at
`everything, we do know that these patients we believe they were switched from both of
`
`Page 6 of 16
`
`FINAL
`
`Bloomberg Transcript
`
`Exhibit 2133
`Page 06 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`that Lucentis, the doctors there are experienced so we're not sure what's different. We do
`know that they're using a different needle than the one that we supply, we don't know if
`that's the issue. Frankly, these clusters occur and sometimes you just never figure it out,
`but we're continuing to do this. They were also in naive patients and well. I'll tell you this
`and remind you that when you give 30,000 injections you expect to get some rate of
`sterile intraocular information as just a fact of intravitreal injections and these things tend
`to occur in clusters and sometimes people figure it out. You'll see in (inaudible) FDA that
`one person figured it out it was-- one group figured out it was a needle, another group
`could never figure out what it was. So we're going to continue to try and figure this one
`out as well.
`
`Q - Jim Birchenough
`Okay, thanks, Len.
`
`{BIO 5068439 <GO>}
`
`Operator
`
`Jason Kantor of RBC Capital Markets.
`
`Q - Jason Kantor
`{BIO 1957973 <GO>}
`Thank you, and congratulations as well. Just a couple questions on the launch and how
`you're tracking it. I'm wondering as you're doing your guidance, what are your
`assumptions for kind of the drop off in the rate of injections going from the once-a-month
`for three months then dropping off, are you assuming that there's a flattening or even a
`down quarter at any point this year? And I guess when you're looking at what patients are
`coming on the drug, how many of these are switching versus newly diagnosed or naive
`patients? And is the market actually going with the introduction of EYLEA because more
`people are coming back on the therapy?
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`So, Jason, thanks for your questions, you've asked all the questions that I've been asking,
`unfortunately, I haven't been getting answers because we don't really have the answers.
`We are seeing a significant amount of switching. So we don't know for those patients how
`many doses they'll actually get. We are seeing new patients. We don't know what the
`practice pattern will be out there. We have modeled this in a variety of ways and as I said,
`these forecasts have inherent uncertainty in them. I wish I could give you more specifics,
`we just don't have them.
`
`Q - Jason Kantor
`{BIO 1957973 <GO>}
`You don't have any sense of what percentage of your patients are coming from -- are
`switching from other drugs or--?
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`My guess is that the majority are coming from switches. We've heard lots of comments
`that people are switching even in more difficult patients. But we don't have any formal
`data yet.
`
`Page 7 of 16
`
`FINAL
`
`Bloomberg Transcript
`
`Exhibit 2133
`Page 07 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`Q - Jason Kantor
`Thank you.
`
`{BIO 1957973 <GO>}
`
`A - Leonard Schleifer
`Okay.
`
`{BIO 1463677 <GO>}
`
`Operator
`
`Josh Schimmer of Leerink.
`
`FINAL
`
`Q - Josh Schimmer
`{BIO 6783077 <GO>}
`HI, thanks for taking the question, congrats as well on a strong launch. Maybe you can
`give us a little bit of color in terms of the reimbursement process, what hiccups, if any, are
`out there? If you're expecting that to improve over the course of the year? And what
`feedback you have from the specialists in terms of their comfort level at this point with
`reimbursement and whether that's going to improve over the year as well?
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`Thanks for your question, Josh, I'll turn it to Bob Terifay, our Head of Commercial to
`answer that, please.
`
`A - Bob Terifay
`{BIO 4342122 <GO>}
`Yes, so as Len pointed out in the conference call, the Medicare carriers are all now
`reimbursing for EYLEA, and as you know the vast majority of these patients are covered
`by Medicare. We also do you have reports of commercial coverage. The real concern that
`offices have before they widely adopt the product is to ensure that not only is the 80%
`covered by Medicare reimbursed, but also that the patient co-pay is covered. We are
`seeing the co-pays work through although the insurers that cover co-pays don't move as
`quickly to change their system. So that is resulting in offices going slowly upfront to make
`sure that they're going to get reimbursed. And that'll be the situation over the next
`several months until all the coverage settles out.
`
`But as I say, the Medicare carriers are covering, we are seeing more and more commercial
`payers coming on board and thus far the offices are beginning to see the payments come
`in. So actually things are where we would have expected at this point in a launch with a
`temporary J-code.
`
`Q - Josh Schimmer
`{BIO 6783077 <GO>}
`And does your guidance assume growing comfort with reimbursement or are you just still
`kind of waiting to see how that goes as well?
`
`Bloomberg Transcript
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`Our guidance tries to take into account all of those factors, Josh. But as you can imagine,
`there's so many unknowns, certainly there's some impediment to this launch because of a
`
`Page 8 of 16
`
`Exhibit 2133
`Page 08 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`lack of a permanent J-code and some of these reimbursement issues, co-pays and what
`have you. Nevertheless, it launch is going pretty well. But a lot of uncertainties in terms of
`dose-- number of doses, how may people load-- are going to be loaded, will doctors
`hopefully file the label or will they do the treat and extend or some other paradigm, these
`are-- we've tried our best to model all of this, that's how we came up with the new
`guidance for you.
`
`Q - Josh Schimmer
`Thanks so much.
`
`{BIO 6783077 <GO>}
`
`FINAL
`
`A - Leonard Schleifer
`Thank you.
`
`{BIO 1463677 <GO>}
`
`Operator
`
`Robyn Karnauskas of Deutsche Bank.
`
`Q - Unidentified Participant
`Hello there, it is Olivia in for Robyn today. Congrats on a great guidance, just a couple
`questions on the specifics on EYLEA,. But the run rate looks very strong, but how
`penetrated is the drug in the community versus bigger (stars) and just similar, how big a
`factor was stocking in doctors offices and what your expectation on that?
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`So maybe I'll cover the second and Bob will cover the first. In terms of stocking, our
`estimate is the doctors don't keep much supply at all, perhaps a week at most. Of the
`distributors, maybe one to two weeks at most I would say. Now in terms of the other part
`of your question in terms of-- Bob, you want to deal with that?
`
`A - Bob Terifay
`{BIO 4342122 <GO>}
`So in terms of penetration into practices, what we do know is that approximately 38% of
`practices that by Lucentis have bought EYLEA. So we have penetrated the offices pretty
`well and we do see a good distribution of our usage across practices.
`
`Q - Unidentified Participant
`Great. Thanks.
`
`Operator
`
`Chris Raymond of Robert W. Baird.
`
`Q - Chris Raymond
`
`{BIO 4690861 <GO>}
`
`Page 9 of 16
`
`Bloomberg Transcript
`
`Exhibit 2133
`Page 09 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`Thanks for taking the question. I just wanted to make sure I understand the math a little bit
`here. So, and I jumped on a little bit late, so if you guys cover this already, but if I count
`30,000 vials that you shipped so far and you back out the first-- the last six weeks of 2011,
`are we talking 20,000 vials through mid-February, is that kind of way the math goes?
`
`A - Murray Goldberg
`{BIO 1463711 <GO>}
`Yes, 30,000 minus 10,000 is 20,000, correct. We'll go with that.
`
`Q - Chris Raymond
`{BIO 4690861 <GO>}
`And so-- thank you. And so are we thinking that, so than your numbers if you think about
`gross to net adjustments et cetera that you're talking roughly $34 million for the first six
`weeks of the year?
`
`A - Murray Goldberg
`{BIO 1463711 <GO>}
`I'll let you do the math because I don't want to be nailed down to specifics et cetera, et
`cetera, but I think you're basically on the right track.
`
`Q - Chris Raymond
`{BIO 4690861 <GO>}
`And was there any dynamic between weekly numbers beginning of the year to say mid-
`February?
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`Yes, that I can't tell you but I can tell you from the first six weeks to the last six weeks, so
`before the new year to after the new year, there was definitely a pickup after the new year.
`And not surprising because a lot of docs, first of all, it was a brand-new launch second of
`all, coverage tends to change for patients around the end of the year and so a lot of docs
`actually waited until after the new year, so once they started treatment they knew their
`coverage wouldn't be changing out from under the patient. So we definitely saw an uptick
`in increase in the rate from pre-new year to post new year.
`
`Q - Chris Raymond
`Thanks.
`
`{BIO 4690861 <GO>}
`
`Operator
`
`Steve Byrne of Bank of America.
`
`Q - Steve Byrne
`{BIO 7019262 <GO>}
`Hi, Len, you mentioned the incidence of wet AMD in China, when you consider just total
`prevalence in that country and taking into consideration government and/or private payer
`coverage in those larger cities, how would you estimate the market opportunity in China
`say versus Europe?
`
`Page 10 of 16
`
`FINAL
`
`Bloomberg Transcript
`
`Exhibit 2133
`Page 10 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`Yes, that's a great question. I don't really know how to do that one and I haven't been
`focused on it because this is something that Bayer takes the rowing oar on for us in our
`partnership. While we've split the profits 50/50 outside of the United States, and we are
`obviously very interested, they do the mechanics out there and so-- and they're much
`more in touch with these markets. We can try and ask them and get back to, Steve, I don't
`know the answer.
`
`Q - Steve Byrne
`{BIO 7019262 <GO>}
`And just to follow on to that, do you view that 300 patient study in China as being
`sufficient for approval?
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`I think also we should defer that question to Bayer, I'll find out. I think that the goal would
`be that when you combine it with our other studies and you have a Phase 3 study there
`that we would hope we could get approval.
`
`Q - Steve Byrne
`Thank you.
`
`{BIO 7019262 <GO>}
`
`Operator
`
`Biren Amin of Jefferies.
`
`Q - Biren Amin
`{BIO 7512048 <GO>}
`Yes, thanks for taking my questions and congratulations on the quarter. I was curious,
`what dynamics are driving the switching from Lucentis to EYLEA? And also has any
`Medicare plans denied reimbursement to date that you know of? Thanks.
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`Right, so as far as the switching goes, I imagine, and we've been to several of the medical
`meetings where we've heard this, that the patients who do not get what the doctors
`consider an adequate response to either Lucentis or Avastin, because there's been
`switches to both, are looking to try something that might give them the patients an
`opportunity to do better. That's fairly a typical dynamic when a new product comes to the
`marketplace. Many doctors will look at they are difficult to treat or patients they don't
`think are doing (aptly) well. And I want to say this, we see this both in Lucentis and Avastin
`patients. So I would have to say that that's the-- that dynamic is definitely at play here. But
`Bob, do you want to address the other question about reimbursement?
`
`A - Bob Terifay
`{BIO 4342122 <GO>}
`In terms of any rejections, in the presence of a miscellaneous J-code there are two
`potential codes that can be processed on the paperwork for a given insurer. And
`sometimes if somebody marks down one of them, that particular insurer will not process
`
`Page 11 of 16
`
`FINAL
`
`Bloomberg Transcript
`
`Exhibit 2133
`Page 11 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`the paperwork. So what we have seen is that claims have been sent back to offices and
`then we work through the appeals process. So it seems to be primarily paperwork
`oriented, we have had no outright rejections of EYLEA at the current time.
`
`Q - Biren Amin
`{BIO 7512048 <GO>}
`Fantastic. Thank you.
`
`Operator
`
`Monie Mohinger[ph] of ThinkEquity.
`
`FINAL
`
`Q - Unidentified Participant
`Hi, thanks for taking this call and a great first call. Quick question, I saw that you
`mentioned that you're expanding into BRVO, could you elaborate a little bit more on the
`opportunity in the BRVO market?
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`Bob, do you want to just in terms of the number of patients and things like that
`approximate, do we have that?
`
`Q - Unidentified Participant
`All Lucentis is doing there and what kind of market it opens up for you beyond wet AMD
`and the CRVO?
`
`A - Bob Terifay
`{BIO 4342122 <GO>}
`So I'll give you a broad -- the BRVO in terms of market size falls in between the size of the
`CRVO market in the AMD market. So it will add a fairly substantial additional market
`opportunity for EYLEA. As you mentioned, Lucentis is now approved in branch retinal vein
`occlusion and patients, or people have-- physicians are responding very well to the use of
`anti-VEGF in that setting.
`
`Q - Unidentified Participant
`Thank you, I'll step back in the queue.
`
`Operator
`
`Yaron Werber with Citigroup.
`
`Q - Yaron Werber
`{BIO 19486720 <GO>}
`Great, thanks so much and congrats there, nice launch. (inaudible) I'm going to sneak in
`very two quick questions, just AMD and DME, I'm not sure if you can answer at all, are you
`seeing any usage yet kind of off label in that setting? And then I had a question about
`expenses, if you don't mind.
`
`Page 12 of 16
`
`Bloomberg Transcript
`
`Exhibit 2133
`Page 12 of 16
`
`

`

`Company Name: Regeneron Pharmaceuticals Inc
`Company Ticker: REGN US Equity
`Date: 2012-02-13
`
`A - Leonard Schleifer
`{BIO 1463677 <GO>}
`As far as we know the predominant use of the product is in AMD and of course we don't
`discuss that, we don't promote it, so we really wouldn't even be in a position to get
`feedback if they were using it. But from what we hear, spontaneously at the conferences
`and what have you, the discussion is centered virtually completely around AMD as it
`should. Now I didn't hear your second question, Yaron.
`
`Q - Yaron Werber
`{BIO 19486720 <GO>}
`So I have a question on depending on what we model, I mean if you look at the model,
`the two biggest questions number one what's (inaudible), but you've given us great color
`there. So we can kind of start thinking about what are you going to record from the
`collaboration revenue with Sanofi and then kind of what your expenses are going to be,
`but I guess where I'm going with this is there any scenario by which you can be profitable
`this year?
`
`FINAL
`
`A - Leonard Schleifer
`Murray?
`
`{BIO 1463677 <GO>}
`
`A - Murray Goldberg
`{BIO 1463711 <GO>}
`Let me first comment in terms of your question about R&D, which is obviously the largest
`expense item on our income statement. For th