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Sarepta Therapeutics (NASDAQ: SRPT)
Q1 2023 Earnings Name
Could 02, 2023, 4:30 p.m. ET
Contents:
- Ready Remarks
- Questions and Solutions
- Name Members
Ready Remarks:
Operator
Good afternoon and welcome to the Sarepta Therapeutics first-quarter 2023earnings name Right now, all members are in a listening mode. After the speaker’s presentation, there will probably be a question-and-answer session. [Operator instructions] Once more, as a reminder, at present’s program is being recorded.
Right now, I will flip the decision over to Mary Jenkins, affiliate director, investor relations. Please go forward.
Mary Jenkins — Affiliate Director, Investor Relations
Thanks, Shannon, and thanks all for becoming a member of at present’s name. Earlier this afternoon, we launched our monetary outcomes for the first-quarter 2023. The press launch is offered on our web site at sarepta.com, and our 10-Q was filed with the Securities and Trade Fee this afternoon. Becoming a member of us on the decision at present are Doug Ingram, Ian Estepan, Dallan Murray, and Dr.
Louise Rodino-Klapac. After our formal remarks, we’ll open the decision for Q&A. I might like to notice that in this name, we’ll be making numerous forward-looking statements. Please take a second to assessment our slide on the webcast which incorporates our forward-looking statements.
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These forward-looking statements contain dangers and uncertainties, a lot of that are past Sarepta’s management. Precise outcomes may differ from these forward-looking statements and any such dangers can materially and adversely have an effect on the enterprise, the outcomes of operations, and buying and selling costs for Sarepta widespread inventory. For an in depth description of relevant dangers and uncertainties, we encourage you to assessment the corporate’s most up-to-date quarterly report on Kind 10-Ok filed with the SEC, in addition to the corporate’s different SEC filings. The corporate doesn’t undertake any obligation to publicly replace its forward-looking statements, together with any monetary projections supplied at present based mostly on subsequent occasions or circumstances.
And now I will flip the decision over to our president and CEO, Doug Ingram, who will present an summary of our current progress. Doug.
Doug Ingram — Chief Government Officer
Thanks, Mary. Good afternoon and thanks for becoming a member of Sarepta Therapeutics’ first-quarter 2023 monetary outcomes convention name. Maybe you will notice this as a break from the previous, however I intend to maintain my remarks this night transient. As you realize, in a mere 10 days from now, we will probably be attending and presenting on the FDA advisory panel for SRP-9001, our gene remedy meant for the therapy of Duchenne muscular dystrophy.
We imagine that the first areas of debate on the advisory committee will probably be these: whether or not the totality of proof helps the conclusion that SRP-9001 dystrophin protein on the ranges expressed by this remedy within reason more likely to predict medical profit. The totality of the proof will embody pure historical past, the preclinical knowledge, biomarker outcomes, and the useful outcomes from our medical trials. The panel will even deal with the risk-benefit evaluation related to the administration of SRP-9001 for the therapy of ambulatory sufferers with DMD within the context of accelerated approval. And eventually, an evaluation of the flexibility to carry to conclusion EMBARK, or research 301, the proposed post-marketing confirmatory trials to help the accelerated approval of SRP-9001 within the occasion that accelerated approval is granted.
The crew is nicely ready and excited to share with the advisory committee the wealth of compelling proof supporting the conclusion that SRP-9001 dystrophin protein within the quantities expressed by that remedy within reason more likely to predict medical profit. So, to set expectations for this name, we intend to debate first-quarter efficiency, and Dr. Louise Rodino-Klapac will present a pipeline replace. However to respect the method and in gentle of how quickly the assembly will happen, we is not going to talk about or entertain questions on regulatory issues pertaining to SRP-9001 or the upcoming advisory committee assembly till it is concluded on Could twelfth.
Transferring now to the quarter, I’m very happy to announce one other robust quarter of efficiency. First-quarter whole income got here in at $253.5 million. Internet product income got here in at $231.5 million, that is a 23% enhance over the identical quarter of the prior yr and exceeding analyst consensus. It’s this very affected person oriented execution that we intend to use to SRP-9001 if accredited.
We proceed to progress our necessary post-marketing commitments for our three accredited PMO therapies. We have now already accomplished 11 of our post-marketing commitments. With respect to ESSENCE, which is our two-year blinded placebo-controlled research for Vyondys and Amondys, we had been absolutely enrolled final yr, and that trial is continuing. With respect to MIS51ON, which is our dose-ranging post-marketing dedication for Exondys, half 2 of that research is considerably enrolled and progressing.
Because it pertains to SRP-9001, along with making ready for the Could twelfth advisory committee and prosecuting the BLA with the Could twenty ninth PDUFA date in thoughts, we’re making certain that we are going to be ready to efficiently launch 9001 and serve the group if and when accredited. By now, we’ve efficiently concluded all FDA inspections that features three GMP inspections and two GCP inspections. With our associate, Catalent, we’re producing materials to efficiently launch 9001 upon approval, and we’re finalizing our launch readiness work. And we’re finalizing our plans to start the research essential to increase the 9001 label to the broadest inhabitants supported by the science, together with our graduation of our non-ambulatory research, ENVISION Examine 303, and our a number of research to discover the removing of neutralizing antibodies to rAAVrh74.
Past that, we have been advancing our broader pipeline, and Dr. Rodino-Klapac will present an replace on our pipeline momentarily. Now the approaching weeks and months are monumentally necessary to the sufferers that we serve. As I’ve mentioned many occasions by now, we stand at a bellwether second with the best evidence-based hope but in historical past to carry a greater life to households at present residing with and, sadly, at present, dying from Duchenne muscular dystrophy.
And we’re additionally nicely conscious that this BLA stands as a bellwether check for gene remedy itself and for the flexibility to successfully lean in and use the instruments obtainable to us to translate groundbreaking genetic science to medication that may prolong and enhance sufferers’ lives now, not merely at some theoretical level sooner or later. We really feel an infinite obligation to the sufferers that we serve, and our each choice and motion is taken and executed with that obligation entrance of thoughts. And with that, let me flip the decision over to our Head of R&D and Chief Scientific Officer Dr. Louise Rodino-Klapac.
Louise?
Louise Rodino-Klapac — Government Vice President, Chief Scientific Officer
Thanks, Doug. Good afternoon. As we look ahead to the weeks and months forward, we stay resolute in our conviction and our values to observe the science and current the target proof that helps SRP-9001’s capacity to vary the trajectory of Duchenne muscular dystrophy. Our purpose with SRP-9001 is to change the course of this deadly illness by treating the underlying reason for Duchenne with a one-time gene remedy that delivers useful dystrophin to the muscle tissue.
Sarepta generated essentially the most compelling preclinical biomarker and medical useful outcomes thus far, greater than every other gene remedy in improvement for Duchenne. We have been in a position to exhibit based mostly on the robust scientific underpinning of our assemble that early SRP-9001 knowledge supplied read-through for our constructive medical expertise with the remedy. After years of analysis, we recognized an optimum gene cassette in a position to retain essentially the most crucial, protecting, and useful components and match inside AAV, thereby enabling its supply. This gene cassette was packaged into our AAV of selection, rAAVrh74, and we selected MHCK7 as our promoter.
The early knowledge confirmed strong expression throughout skeletal, diaphragm, and cardiac muscle. And on account of that expression in addition to the dystrophin protein demonstrating useful advantages, we noticed medical advantage of the goal dose in sufferers with Duchenne. I’ll clarify in a bit extra element. People with Duchenne haven’t got a functioning dystrophin-associated protein complicated for that state.
Understanding this, after we inserted a useful dystrophin protein, we noticed upregulation of DAPC in animal fashions. Extra particularly, we noticed an nearly one for one upregulation of the DAPC when there was expression of the SRP-9001 dystrophin, confirming the protecting properties of the protein. Additional, we noticed important discount in creatine kinase, or CK. CK is an enzyme related to muscle injury.
The rejection of CK supplied additional proof that SRP-9001 was fairly more likely to predict medical profit. Since 2018 and throughout a number of research who does the biggest variety of Duchenne sufferers greater than every other gene remedy in improvement for this illness, and the medical outcomes have surpassed our expectations. In abstract, SRP-9001 demonstrated strong expression of dystrophin, far above what literature would recommend is important to be protecting of the muscle. All of it’s correctly localized on the muscle membrane, or sarcolemma, the place it acts as a shock absorber.
We developed a cell-based efficiency assay that exhibits that SRP-9001 is lively, useful, and protecting on the muscle membrane and as in animal fashions with strong expression of SRP-9001 with important discount of CK. Lastly, expression of SRP-9001 in sufferers results in upregulation of the DAPC. Along with all of this compelling proof, we had been in a position to present useful advantages versus what pure historical past would predict on NSAA, or the North Star Ambulatory Evaluation, which is our main useful endpoint. We noticed profit throughout one, two, and four-year time factors.
Based mostly on the totality of the information, we imagine that SRP-9001 qualifies as a disease-modifying agent as on the ranges of dystrophin expressed are fairly more likely to predict medical profit in sufferers with Duchenne. Now transferring to limb-girdle muscular dystrophy, or LGMD. We stay dedicated to advancing our LGMD portfolio throughout a wide range of subtypes. I look ahead to offering updates on these necessary applications within the months forward.
At present, we’re making wonderful progress on Journey, our LGMD pure historical past research; and in VOYAGENE, our section 1 research evaluating SRP-9003 for the limb-girdle muscular dystrophy Kind 2E in ambulant grownup sufferers and non-ambulant sufferers inside medical course of SRP-9003. Mixed with constructive expression and useful knowledge shared from our preliminary research, SRP-9003-101, we imagine the information from VOYAGENE will give us insights right into a broader affected person inhabitants. Our subsequent milestones for VOYAGENE embody finishing enrollment within the second half of the yr and starting our section 3 research utilizing commercially consultant processed supplies later within the yr. Lastly, we’re on observe to start a systemic pilot research for SRP-606-004 dual-vector rh74-mediated gene remedy to deal with LGMD 2B characterised by the absence of the proteins [Inaudible].
Turning now to the progress we made with our RNA platform. We’re happy to finish enrollment within the first quarter of 2023 for our MOMENTUM research for SRP-5051. And we stay on observe to announce knowledge from the research within the again half of 2023. In regard to our post-marketing research for the PMOs, as talked about final quarter, we accomplished enrollment within the ESSENCE trials for post-marketing requirement for [Inaudible] market.
We proceed to make good progress with our MIS51ON research, which is on observe to be absolutely enrolled this yr. In closing, we’re trying ahead to the advisory committee assembly on Friday, Could twelfth, as it would present us the chance to share the science and the information in help of SRP-9001. I might wish to take this chance to thank our Sarepta crew who’ve been diligently working these previous months. I will now flip the decision over to Dallan for an replace on our industrial actions.
Dallan.
Dallan Murray — Senior Vice President, Chief Industrial Officer
Thanks, Louise, and good afternoon. Within the first quarter of 2023, the crew executed on our core RNA enterprise and delivered one other robust efficiency throughout all three of our RNA-based PMO therapies. As Doug talked about, we delivered $231.5 million in internet product income within the first quarter, representing nicely over 20% development over the primary quarter of 2022. Notably, Q1 of 2023 exceeded our expectations and represented essentially the most profitable first quarter within the historical past of our marketed therapies.
In Q1, we’ve traditionally seen an influence within the U.S. resulting from anticipated insurance coverage adjustments to start with of every yr. As a result of extraordinary efforts of the crew in navigating these entry headwinds, we noticed higher-than-expected income within the U.S. within the first quarter.
Annually, our crew is ready for these challenges, and I am very happy with their steadfast dedication and sense of urgency with which they serve [Inaudible] group. They know that each minute issues for every one of many sufferers we serve. Complete ex-U.S. internet product income within the first quarter was roughly $31 million.
This represented a lower over the prior quarter, which was anticipated and absolutely mirrored in our annual steering forecast. As mentioned on final quarter’s name, we count on to see continued fluctuations in ex-U.S. order issues for the quarter. Total, the basics of the enterprise popping out of Q1 are fully in keeping with what we anticipated at this level within the yr.
And we reiterate our full-year steering upgraded to 925 million in internet product income for our PMO therapies. This steering displays all the components that we navigate and monitor in supporting sufferers globally. With this growing international income base, we’ll proceed to see fluctuations within the internet product income recorded within the quarter. Importantly as nicely within the U.S.
market, we’ve now hit a mature section with all three merchandise, and as such, we count on extra modest development and new affected person begins within the coming quarters for the PMO enterprise. Turning now to particular person internet product revenues for the primary quarter of 2023 for our three accredited RNA-based chemotherapies. Exondys 51 totaled $132.6 million, representing greater than 13% development over Q1 of 2022. Our Vyondys 53 gross sales had been $33 million, rising roughly 18% over the primary quarter of 2022.
And our Amondys 45 gross sales totaled $65.9 million, representing greater than 50% development versus Q1 of 2022. Along with the robust efficiency in our core enterprise, the crew has been concurrently making ready and laying the groundwork for the SP-9001 launch. The complete crew is in place, being rigorously educated as we converse, and I can say with confidence that they’re able to execute if SP-9001 is accredited. This launch will signify a historic second not just for Sarepta however for the Duchenne group and for genetic medication.
The extent of enthusiasm and confidence of the crew is at an all-time excessive, and they’re looking forward to this chance to exhibit what we’re able to and what can be our fourth launch within the Duchenne market. Over the previous a number of months, our subject groups and Sarepta management have meaningfully engaged with roughly 75 websites of care on strategic and operational web site readiness issues. These necessary interactions are to make sure that the websites are able to effectively, safely present SRP-9001 gene remedy to sufferers as quickly as potential. We have additionally been working carefully with websites to supply schooling and coaching in addition to making certain that they’ve the mandatory gear and assets to ship the remedy to sufferers.
Along with web site readiness, we all know from our expertise with PMO therapies that entry and reimbursement are essential to efficiently delivering SRP-9001 to sufferers. We’re dedicated to making sure that our gene remedy for Duchenne is accessible to all sufferers who want it, and we acknowledge that meaningfully participating with payers is a crucial a part of attaining that purpose. We discovered that the payers are asking necessary questions pertaining to the SRP-9001 medical knowledge, potential affected person inhabitants dimension, launch timing, and infusion websites. We’re inspired by the constructive response we obtained up to now and are happy on the progress we’ve made in participating with each industrial and Medicaid payers.
If accredited, 9001 will carry forth the doubtless transformative remedy to sufferers who’ve been ready for much too lengthy. The crew has executed an amazing job, making ready for what would be the largest gene remedy launch thus far if SRP-9001 is accredited. I might wish to take this chance to personally thank the entire group who should not solely executing to help the 30% of sufferers on our [Inaudible] at present however have additionally risen to the event in order that we will be prepared as a crew for this paradigm-shifting second. And now I will flip the decision over to Ian for an replace on our financials.
Ian.
Ian Estepan — Chief Monetary Officer
Thanks, Dallan, and whats up, all. This afternoon’s monetary outcomes press launch supplied particulars for the primary quarter of 2023 on a non-GAAP foundation in addition to a GAAP foundation. Please check with the press launch obtainable on Sarepta’s web site for a full reconciliation of GAAP to non-GAAP monetary outcomes. For the three months ended March thirty first, 2023, the corporate recorded whole revenues of $253.5 million, which include internet product revenues and collaboration revenues, in comparison with revenues of $210.8 million for a similar interval of 2022, a rise of $42.7 million.
Internet product income for the primary quarter of 2023 from our PPMO exon skipping franchise was $231.5 million, in comparison with $188.8 million for a similar interval of 2022. The rise in internet product income primarily displays growing demand of our merchandise. In every of the quarter ended March thirty first, 2023 and 2022, we acknowledged $22 million of collaboration income which pertains to our collaboration association with Roche. The reimbursable co-development prices underneath the Roche settlement totaled $20.3 million for the primary quarter of 2023, in comparison with $17.7 million for a similar interval of 2022.
On a GAAP foundation, we reported a internet lack of $516.8 million, or $5.86, and $105 million, or $1.20 per primary and diluted share, for the primary quarter of 2023 and 2022, respectively. This modification is primarily because of the loss on debt extinguishment of $387.3 million, a noncash expense incurred within the three months ended March thirty first, 2023 with no related exercise for a similar interval of 2022. We reported a non-GAAP internet lack of $85.5 million, or $0.97 per primary and diluted share, within the first quarter of 2023, in comparison with a non-GAAP internet lack of $48.6 million, or $0.56 per primary and diluted share, within the first quarter of 2022. Within the first quarter of 2023, we recorded roughly $35 million in value of gross sales, in comparison with $31.4 million in the identical interval of 2022.
The rise in value of gross sales is primarily resulting from an growing demand for our merchandise in addition to proper off of sure batches of our merchandise not assembly the standard specs for the three months ended March thirty first, 2023 with no related exercise in the identical interval of 2022, partially offset by a lower within the royalty funds throughout the three months ended March thirty first, 2023 resulting from adjustments within the BioMarin royalty time period. On a GAAP foundation, we recorded $245.7 million and $194.3 million in R&D bills for the primary quarter of 2023 and 2022, respectively, a year-over-year enhance of $51.4 million. The rise is primarily resulting from a rise in our manufacturing bills. On a non-GAAP foundation, R&D bills had been $220.7 million for the primary quarter of 2023, in comparison with $173.2 million for a similar interval of 2022, a rise of $47.5 million.
Now turning to CIGNA,SG&A. On a GAAP foundation, we recorded roughly $110.7 million and $71.8 million for bills for the primary quarter of 2023 and 2022, respectively, a rise of $38.9 million. The rise was pushed primarily by a rise in skilled service bills to arrange for a possible launch of SRP-9001. On a non-GAAP foundation, the SG&A bills had been $83.3 million for the primary quarter of 2023, in comparison with $53.2 million for a similar interval of 2022, a rise of $30.1 million.
We count on that our R&D and SG&A expense will enhance subsequent quarter as we proceed to arrange for a possible launch of SRP-9001. On a GAAP foundation, we recorded $12.7 million in different revenue, internet, for the primary quarter of 2023, in comparison with $17.3 million in different expense, internet, for a similar interval of 2022. The change is primarily resulting from a rise in curiosity revenue and accretion of funding low cost because of the funding mixture of our funding portfolio in addition to a discount of curiosity expense incurred on account of the compensation of our December 2019 time period mortgage throughout 2022. Within the first quarter, we exchanged a portion of our 2024 notes with an mixture principal worth of $313.5 million and issued roughly 4.5 million shares of our widespread inventory.
We accounted for the change of the debt extinguishment recognizing the distinction of the honest worth of the shares of widespread inventory transferred on the change date and the web carrying quantity of the extinguished debt as a lack of $387.3 million, inclusive of the $6.9 million of third-party debt conversion prices, simply, once more, to reiterate this can be a noncash expense. We had roughly $1.9 billion in money, money equivalents, and investments and long-term restricted money as of March thirty first, 2023. We stay nicely capitalized to execute on our targets for the yr and help our transition to profitability assuming approval of SRP-9001. And with that, I will flip the decision again over for Doug to start out the Q&A.
Doug?
Doug Ingram — Chief Government Officer
Thanks, Ian. Now earlier than we start the Q&A, let me reiterate and in gentle of — and in respect of the approaching FDA advisory committee, we is not going to be entertaining questions on the regulatory course of for the upcoming advisory committee assembly for SRP-9001 tonight. I do look ahead to discussing these issues with you as soon as the Could twelfth advisory committee assembly has concluded. And with that, Shannon, let’s open the road for questions.
Questions & Solutions:
Operator
Thanks. [Operator instructions] Our first query comes from the road of Colin Bristow with UBS. Your line is now open.
Colin Bristow — UBS — Analyst
Hey, good afternoon. And, you realize, simply congrats on being on the cusp of this approval. So, in your provide at launch, are you able to discuss concerning the capability and skill to satisfy demand? I am simply asking in gentle of the very fact of — or among the feedback out of your associate round a slower-than-expected manufacturing ramp on the Maryland web site. After which, simply kind of inside this, by way of affected person logistics, are you able to discuss your expectations for the preliminary timelines from a doctor prescribing 9001 to a affected person receiving the remedy given the necessity for antibody testing and different potential labeling necessities? Thanks.
Doug Ingram — Chief Government Officer
Yeah, thanks very a lot for that, Colin. So, on the primary a part of the query, as we have mentioned, our purpose — and we’ll meet that purpose — is to have the ability to absolutely launch and provide the group assuming that we’re in a position to get an approval. After all, our purpose proper now could be to get an approval on the PDUFA date, which is Could twenty ninth. We have now seen the feedback made by Catalent that we’re very clear that these feedback and the problems that they had been discussing don’t play any function in or have any impact on our plans or our manufacturing plans within the slightest.
So, we must be in good condition there. With respect to the launch, you realize, our purpose is to launch this remedy as quickly as potential. And I believe we’ve confirmed ourselves over the previous couple of years very able to doing precisely that. With that mentioned, the 9001 gene remedy has its personal specific issues.
You have obtained it, as an illustration, along with not merely having a starch type for that. You going to do numerous different issues together with getting a pre-infusion antibody check that is sufficiently near the infusion, that it is legitimate. After which, after all, they don’t seem to be — they usually — you need to — must work by means of entry to reimbursement and codes and the like. So, from a planning perspective, whereas we’ll be launching this quickly, one ought to anticipate actually seeing, you realize, 1 / 4 or two earlier than we actually begin seeing a big ramp.
Operator
Thanks. Our subsequent query comes from the road of Gena Wang with Barclays. Your line is now open.
Gena Wang — Barclays — Analyst
Thanks. I additionally needed to ask one industrial query. What’s your estimate affected person numbers for preliminary indications within the U.S.? And likewise, relating to the manufacturing capability, any main growth you should do as a way to provide affected person for the preliminary indication within the U.S.?
Doug Ingram — Chief Government Officer
Let me reply the second half first. The answer is no. There aren’t any main capital expenditures or extra growth that’s required to launch this remedy and serve the group at launch. On the addressable affected person inhabitants, I can provide the broadest of strokes.
They’re someplace within the 12,000, 10,000 to fifteen,000 sufferers in the US. Our purpose — once more, assuming that we’re accredited at a PDUFA date, the purpose is to serve all ambulatory sufferers. The ambulant sufferers are about 50%, so it is roughly 50% ambulant, 50% non-ambulant. We will probably be protecting the ambulant inhabitants, after which, there will probably be, after all, sufferers that may be excluded as a result of they’ve preexisting neutralizing antibodies.
Based mostly on our most up-to-date knowledge, that is about 13.5% of sufferers can be at present excluded on the idea of getting preexisting antibodies to binding antibodies to rh74. After which, there’s a subset of sufferers who would have a few of these earlier mutations in a variety — in a area that will have a danger of an innate immune response. That’ll be lower than 5% of sufferers. So, that the rest is the addressable affected person inhabitants at launch.
Now, with that mentioned, I will go forward and offer you our plans for the long run as nicely as a result of, you realize, very quickly we will be beginning numerous research in an effort to completely construct out the addressable affected person inhabitants to the extent that science permits us to. We’re fairly assured about that. In order that the most important alternative clearly is to get to the nonambulant sufferers. That’s terribly necessary to us and to them.
Nonambulant sufferers haven’t got the luxurious of time, so we have got to maneuver as quick as potential. We’re beginning our research 303 for the nonambulant inhabitants very quickly. The purpose is to have enough security and expression knowledge from that research to hunt an replace to our label early subsequent yr to get nonambulant sufferers within the label so we will start to dose them. And we’re beginning as nicely two extra research for 2 various approaches to clear preexisting neutralizing antibodies.
And if we’re able to doing that, then that may additionally carry again into to border for the flexibility to dose sufferers which can be at present excluded as a result of they’ve — they’ve one thing that reacts and is a preexisting neutralizing antibody. That is an awfully necessary problem as nicely. , oftentimes, you will — once you discuss to sufferers and their households, dad and mom will say that the worst day of their lives was getting the information that their little one had Duchenne muscular dystrophy and that the second worst day of their lives was discovering out that their youngsters are one in every of these, you realize, uncommon youngsters, about 13% of youngsters who’ve examined constructive for preexisting neutralizing antibodies. So, we have to transfer quick to attempt to resolve that problem for them.
Thanks for these questions, Gena.
Operator
Thanks. Our subsequent query comes from the road of Brian Abrahams with RBC Capital Markets. Your line is now open.
Brian Abrahams — RBC Capital Markets — Analyst
Hello, good afternoon. Thanks for taking my query. Are you able to increase on what you’ve got been listening to in your preliminary conversations with payers? Is your sense that they’d be open to paying for 9001 underneath accelerated approval or would favor to attend for full approval? And will we count on kind of an analogous combine as with the exon skippers close to the proportion of sufferers initially receiving entry? Thanks.
Doug Ingram — Chief Government Officer
I wish to say the broadest of strokes and you’ll observe up on lacking something. To begin with, the conversations have gone very nicely. We have been in dialogue with payers relating to the potential for SRP-9001 for a few years now. And I can — you realize, going again so far as mid-2018, Dallan, myself, and others had been assembly with payers.
The — our accident reimbursement crew have been assembly with payers considerably. The quantity of proof that we’ve that helps the conclusion that 9001 is a useful remedy for teenagers and goes to do quite a lot of good may be very, very strong. So, these discussions have gone very nicely. With that mentioned, let me be very clear, after all, you realize, as is the case with uncommon illness therapies proper now, truly, reimbursement is a sophisticated and difficult factor.
The excellent news for all of us is that 9001 goes to be launched by Sarepta. And, you realize, on the danger of sounding a bit conceited, for my part, there isn’t a crew higher than this Sarepta crew to serve these sufferers, work intelligently with payers, and acquire entry for this remedy for these youngsters as quickly as potential. And I’m fairly assured that is going to happen. I am fairly assured payers are going to do the suitable factor, and definitely I imagine that they are going to do the suitable factor within the context of accelerated approval, which is, from our perspective, the strategy that — that one must be taking with respect to 9001 given the information that we’ve in entrance of us.
Dallan Murray — Senior Vice President, Chief Industrial Officer
Yeah, and I believe — I believe Doug’s actually coated it. There are, as we mentioned in — within the opening remarks, actually constructive, nice dialogue happening with the payers. And proper now, we’re — you realize, we’re — we’re — previous to launch, they’re asking nice questions on timing and the affected person inhabitants. And I believe, extra particularly, Colin, to your query, no matter when the insurance policies are put in place, the payers are going to have a look at every affected person on a case-by-case foundation.
And so, the crew, as Doug mentioned, is able to handle — able to handle that proper from day one.
Doug Ingram — Chief Government Officer
We’re skilled and battle-hardened crew.
Operator
Thanks. Our subsequent query comes from the road of Judah Frommer with Credit score Suisse. Your line is now open.
Judah Frommer — Credit score Suisse — Analyst
Hello, thanks for taking the query. One other one kind of from the payer angle. Any thought if there could possibly be form of a distinction in RAM for sufferers which can be, you realize, I assume, naïve to RNA therapies versus these which can be — which can be on the PMOs gaining entry? After which, any indications round potential value-based funds, given such as you mentioned, that is going to be the most important gene remedy launch ever? So, from a value perspective, may there be any, I assume, attention-grabbing dynamics to — to the time of funds? Thanks.
Doug Ingram — Chief Government Officer
Yeah, because it pertains to the primary query, I do not assume there’s going to be a distinction in RAM. I believe that is — for many who are amenable to this remedy, which at launch we’re profitable, our BLA can be ambulant sufferers, excluding a really slender vary of mutations who’re rh74 unfavorable. I believe this remedy goes to be terribly necessary. And I believe that there is going to be an equal ramp, whether or not you are naïve or not naïve to — to the PMO.
And in reality, we’ve dosed sufferers which have been on the PMO and remained on the PMO post-dose. So, we’ve good knowledge that helps that. On value-based agreements and the like, I am not at a spot proper now the place we will talk about these points but. I’ll inform you that we’ve executed an infinite quantity of labor, about which I’m extraordinarily impressed and proud to border the worth proposition and the pharmacoeconomic mannequin for one-time therapies like SRP-9001.
And our strategy to the payer group pricing value-based agreements and the like will probably be contained in the body of that worth framework itself. And the one factor I’ll inform you, qualitatively not less than, and can on the proper time discuss quantitatively, is that the worth that this remedy will carry to Duchenne sufferers goes to be considerably better than the price of this remedy to the healthcare system, which is what all of us ought to need.
Operator
Thanks. Our subsequent query comes from the road of Salveen Richter with Goldman Sachs. Your line is now open.
Salveen Richter — Goldman Sachs — Analyst
Good afternoon. Thanks for taking my query. With regard to manufacturing, are you able to simply present us with some particulars of the place you stand on stock as you look to this launch, after which, the breadth of your manufacturing relationships as a way to deal with the availability that is required over not less than the primary yr or second — or first two years of launch right here?
Doug Ingram — Chief Government Officer
Positive, so we’re constructing stock, as we converse, to be prepared for launch. So, that is clearly an ongoing exercise with Catalent. It is a excessive precedence for us and, luckily, additionally a excessive precedence for Catalent, so we’re in nice form there. And that is nice for launch and we’re in nice form there.
Should you look down the highway long term, after all, we even have our relationship with Thermo Fisher. We have now a complete stand-alone web site with Thermo Fisher. One of many selections we made in reference to our BLA submission was to not attempt to get two websites accredited on the similar time. The complexity related to that may have created a big danger of delay.
And, you realize, I believe, as we have mentioned one million occasions, you realize, delay isn’t one thing that sufferers with Duchenne can — can have. So, what we’ll do post-launch is figure with the division to get the Thermo Fisher web site up and operating and certified as nicely. The excellent news is at launch, this our — our web site with Catalent and our suites with Catalent is enough to — to launch the remedy and serve the group.
Operator
Thanks. Our subsequent query comes from the road of Gil Blum with Needham and Firm. Your line is now open.
Gil Blum — Needham and Firm — Analyst
Good afternoon, everybody, and thanks for taking our query. Doug, in your earlier feedback, you talked about that the corporate is planning to start out among the different research together with on nonambulatory sufferers and the clearing of antibody research. What about planning a research in youthful sufferers? I am assuming that, you realize, as with all gene remedy, youthful is normally higher. Thanks.
Doug Ingram — Chief Government Officer
Yeah, nicely, let me — let me touch upon that final piece first. This can be very necessary that we get to youthful sufferers as nicely, I wish to be very clear. However I wish to be additionally clear that, from our perspective, there isn’t a place throughout this journey of Duchenne the place the intervention of a remedy, like 9 years or one, that may restore useful dystrophin to sufferers, will not be useful. There isn’t any — there is no little one that is past worth, that is necessary to recollect.
So, in the event you’re 19 years previous and you have been in a wheelchair for 5 years, you might be as invaluable to us as a really younger little one. So, that is — in order that’s why we’re very targeted on the nonambulant aspect, however we’re targeted on the very younger as nicely. We have already dosed youngsters which can be down to a few years previous. Louise would possibly wish to touch upon different plans.
We have now that a lot youthful youngsters as nicely.
Louise Rodino-Klapac — Government Vice President, Chief Scientific Officer
Yeah. We have three-year-olds in our 103 research. After which, we’re additionally planning an extra research together with Roche to dose even youthful than the three-year-olds, and that may start briefly time period.
Operator
Thanks. Our subsequent query comes from the road of Tazeen Ahmad with Financial institution of America. Your line is now open.
Tazeen Ahmad — Financial institution of America Merrill Lynch — Analyst
Hello, good afternoon. Thanks for taking my questions. I assume, Ian, I simply needed to make clear a remark that you simply made relating to write-offs of sure batches of the corporate’s merchandise that weren’t assembly high quality specs. Which merchandise had been they, are you able to share? And have you ever resolved that problem? After which, additionally, perhaps simply to observe up on feedback that Doug made relating to inspections being accomplished, are you able to additionally affirm whether or not or not FDA has any feedback on the inspection? And if they’ve, have they been resolved? Thanks.
Ian Estepan — Chief Monetary Officer
Positive, I will take the primary one first, that was relating to the PMO. That is simply a part of our regular manufacturing course of. Should you look again over a number of quarters, that is occurred. So, you realize, that is simply one thing that is a part of the conventional manufacturing course of.
And, you realize, there’s some batches that do not meet specs and we’ve to jot down it off however nothing to be involved and must be anticipated to proceed to go far.
Doug Ingram — Chief Government Officer
After which, because it pertains to the second query, all the inspections are accomplished, and any of the observations have been solely glad. So, we’re in nice form from an inspection perspective.
Operator
Thanks. Our subsequent query comes from the road of Danielle Brill with Raymond James. Your line is now open.
Danielle Brill — Raymond James — Analyst
Hello, guys, thanks — thanks a lot. I even have a few questions on EMBARK. Curious what % of sufferers have accomplished that trial, simply attempting to gauge how back-end load an enrollment was. After which, additionally, how often do you measure NSA? And the way are lacking knowledge imputed? Thanks.
Doug Ingram — Chief Government Officer
I will take the final half however the first half, of the sufferers.
Louise Rodino-Klapac — Government Vice President, Chief Scientific Officer
Yeah. So, the research was fully enrolled final fall by way of the — so we will count on the one-year endpoint to shut out this fall with the — the research report early subsequent yr. The NSA — these are the first endpoint for the NSA is at one yr. However we measure it at intervals previous to that, definitely, previous to once you’re at endpoint.
Doug Ingram — Chief Government Officer
One factor on the workers plan after we announce the outcomes.
Operator
Thanks. Our subsequent query comes from the road of Mike Ulz with Morgan Stanley. Your line is now open.
Mike Ulz — Morgan Stanley — Analyst
Hey, guys, thanks for taking the query. Simply one other one on the 9001 launch, do you’ve got a way of what number of sufferers would possibly wish to swap from a few of your PMO therapies, and the way do you intend to handle that? Thanks.
Doug Ingram — Chief Government Officer
So, let me say two issues. First, we do not anticipate at launch a big influence on our present PMO income from a income perspective. In the long term, one would possibly — one ought to assume some important cannibalization. It will not occur early on.
To the extent {that a} affected person needs to change from PMO to have entry to the gene remedy, we’ll embrace that and be, you realize — I am excited for that.
Operator
Thanks. Our subsequent query comes from the road of Neena Bitritto-Garg with Citi. Your line is now open.
Neena Bitritto-Garg — Citi — Analyst
Hey, guys, thanks for taking my query. I simply needed to return to among the questions on the payer dialog to this point. Are you able to simply inform us just a little bit about whether or not any of your conversations to this point have urged that payers could wait to really problem protection determinations till they see the EMBARK knowledge? And if that’s the case, how they might take into consideration, you realize, form of restrictions and the protection coverage post-EMBARK? Thanks.
Doug Ingram — Chief Government Officer
We intend to launch this remedy and work with payers to get entry to this remedy instantly. I might remind people that we’ve three accredited therapies at present, Exondys, Vyondys, and Amondys. All of them had been accredited for the accelerated approval pathway. And the crew has executed, for my part, a completely sensible job of working with payers to make sure fast entry for sufferers who’re amenable to these three therapies.
We’ll take that very same execution focus. We’ll apply it to 9001. And we anticipate that payers are going to reply nicely given the robustness of our knowledge and are going to have entry instantly.
Operator
Thanks. Our subsequent query comes from the road of Tim Lugo with William Blair. Your line is now open.
Tim Lugo — William Blair and Firm — Analyst
Yeah, thanks for taking the query. Better of luck, clearly. Are you able to discuss the way you view capital deployment in a post-approval function? You clearly have quite a lot of research we have talked about; you need to construct the label out your self, these in limb-girdle. And I imagine your pipeline is described as 40-compound deep.
So, that feels like quite a lot of R&Ds. And I might love to listen to your ideas round that, which might be cash extraordinarily nicely spent however perhaps if that additionally influences your ideas round pricing of 9001.
Doug Ingram — Chief Government Officer
Properly, I will say two issues. I need to flip this to Ian who can remark about capital deployment in additional basic sense. And let’s first — we’re going to considerably deal with analysis and improvement and the like, after all. And we’ll proceed to do this deep into the long run.
That however, we’ll — our present plans, assuming that we’re accredited and our plans come to fruition, would have us being worthwhile subsequent yr. Because it pertains to the pricing for 9001, the pricing of 9001 will happen within the context of the — within the pharmacoeconomic fashions we use to make sure that the worth is acceptable for that remedy and that — as I mentioned earlier than, that the worth delivered to the sufferers and their lives from this remedy is far better than the fee to the healthcare system. However past that, Ian, you wish to touch upon the capital deployment plans?
Ian Estepan — Chief Monetary Officer
Yeah, no, I believe you are precisely proper, we’re clearly going to proceed to put money into R&D, however we’re additionally going to be targeted on profitability and observe metrics that may — will information that and guarantee returns for our shareholders. However clearly, as you realize, investing in our R&D goes to result in continued development. And we will be targeted on transferring applications ahead which have excessive chance of success based mostly on the information which we generate. We additionally assume the market situations proper now lend itself to, you realize, being able to associate or purchase applied sciences that we predict are scientific breakthroughs as we proceed to construct out our pipeline.
So, we will be very in line with the strategy that we have used beforehand. It is clearly put us able the place we’re one of many main rising biotech firms, and we’re not going to stray from that.
Operator
Thanks. Our subsequent query comes from the road of Kristen Kluska with Cantor Fitzgerald. Your line is now open.
Kristen Kluska — Cantor Fitzgerald — Analyst
Hello, good afternoon, and finest needs to your crew this month. Are you able to discuss concerning the newest because it pertains to taking a look at among the methods you are trying to deal with pretreatments for these with preexisting antibodies to AAV? I noticed that you simply’re presenting with Hansa some preclinical knowledge at AACT. And the agenda was actually simply launched about an hour in the past. So are you able to discuss a few of these efforts, please?
Doug Ingram — Chief Government Officer
Yeah, so there are two approaches, and if there’s extra to say past this, we will have a look. Broadly, there are two approaches that we’re taking proper now. One is, after all, with our associate, Hansa, in imlifidase to cleave and due to this fact take away antibodies that stand in the best way of a kid getting 9001. And the opposite is utilizing apheresis to clear antibodies.
So, something you wish to add to that, Louise?
Louise Rodino-Klapac — Government Vice President, Chief Scientific Officer
We have now robust preclinical knowledge with each approaches. And as Doug talked about, we’re planning to start out two medical research on each approaches. So, this has been necessary to us to make it possible for we will serve your entire group.
Operator
Thanks. Our subsequent query comes from Hartaj Singh with Oppenheimer and Firm. Your line is now open.
Hartaj Singh — Oppenheimer and Firm — Analyst
Nice, thanks. Thanks for the query. I simply obtained a fast query on — on the VOYAGENE research in LGMD. , assuming you get that section 3 began with commercially consultant materials by the tip of the yr, how a lot perception will the section 2 and the section 3 offer you into the opposite LGMDs? I imply, may you progress sooner? , may regulators be amenable to taking a look at them holistically versus, you realize, very individually? After which, how simple will or not it’s to scale the manufacturing for all of the others? Thanks for the query.
Doug Ingram — Chief Government Officer
, after I say broadly, you realize — one’s seen public displays from Dr. Peter Marks, you will know that his — his final purpose, his long-term purpose is to get to a spot the place you may construct remedy upon remedy. And notably, in the event you’re utilizing the identical passage which we’re in reference to the LGMDs that try to be studying from every after which with the ability to drastically shorten the timeline. I believe {that a} type of that may happen with our limb girdles, however we’re within the early days of limb girdles, so it will not be absolutely fashioned like that, as we’re — you realize, we’re transferring by means of.
We do get important worth and studying from every of those applications that we apply to the following one. The limb girdles are benefiting enormously from 9001. Keep in mind, most of our limb girdles, the bulk not less than, use the identical promoter as 9001, and so they all use the identical capsid, rh74. So, there may be this virtuous cycle the place we ought to have the ability to begin transferring sooner and sooner over time.
It should take a while to do this. I might say — and eventually, I might say on manufacturing, we positively profit from prior information as we transfer ahead. However every of those applications is its personal program and requires some bespoke components, together with, as an illustration, a lot of the assay work. Among the asset work will be very translatable.
However quite a lot of this assay work is bespoke from — from program to program. And so, that does take a while, and it’ll take a while with respect to a few of these girdles.
Operator
Thanks. Our subsequent query comes from the road of Debjit Chattopadhyay with Guggenheim. Your line is now open.
Debjit Chattopadhyay — Guggenheim Companions — Analyst
Hey, good afternoon and thanks for taking my query. Doug, I simply needed to make clear one of many feedback you made in your ready remarks. You introduced up EMBARK within the context of the end result. May you make clear and body that query once more?
Doug Ingram — Chief Government Officer
Oh, I believe — oh, sure, one of many — the problems that we simply must — to debate on the advisory committee is that — EMBARK, which is our proposed confirmatory trial and clearly wants to finish and full on time. And so, one of many, clearly, affordable questions one would pose is, you realize, are you assured that if we offer you an approval now and on an accelerated foundation that EMBARK will, actually, full, that there will not be one thing concerning the approval of this remedy that may one way or the other affect the flexibility to efficiently full EMBARK. As you realize, EMBARK truly was absolutely enrolled as of final yr — September of final yr. So, I believe relative to different accelerated approval therapies, we’re in a very advantageous, sensible place with respect to the completion of our confirmatory trial.
Operator
Thanks. Our subsequent query comes from the road of Joseph Schwartz with SVB Securities. Your line is now open.
Joseph Schwartz — SVB Securities — Analyst
Hello, everybody. Thanks very a lot. Since we’re so near the panel, I used to be questioning if in case you have seen the FDA’s briefing paperwork at this level and in the event you may give us your gestalt about their tone in order that we will be extra ready for what to anticipate.
Doug Ingram — Chief Government Officer
As I mentioned, we’re 10 days away and counting from the advisory committee assembly. I wish to be very clear about this. What we’re all doing collectively proper now could be terribly severe. It is necessary to us and it is necessary to our buyers, however it’s vastly extra severe and necessary to the sufferers residing with Duchenne muscular dystrophy.
That is actually a possible life-or-death problem for them. So, in regard to that, we’re going to be mission-driven, and what which means to us is we will keep very targeted on prosecuting our BLA, making ready for our adcom. We’re not going to debate the end result or the briefing books or the regulatory course of proper now. We will do a — we will prepare for and, in my humble opinion, we will do an excellent job.
So, I am placing quite a lot of stress on you, Louise. We will do an excellent job of presenting what I imagine to be the wealth of proof that helps the conclusion that 9001 and the quantities made by this remedy within reason more likely to predict medical profit. So, in gentle of that and with all respect and apologies for not answering the query, I am not going to reply questions concerning the regulatory course of by means of the advisory — advisory committee till after Could twelfth. After which, we will all come collectively, and I will be thrilled to speak about all of those points with you.
Operator
Thanks. Our subsequent query comes from the road of Zhi Shu with Berenberg. Your line is now open.
Shu Zhiqiang — Berenberg Capital Markets — Analyst
Good afternoon. Thanks for taking my questions. Perhaps going again to the manufacturing ramp. Doug, are you able to set some expectations on what number of sufferers do you intend to deal with for 9001? And secondly, on 9003 limb girdle program, clearly, you commented the section 3 will begin within the second half of the yr.
Is there any risk for accelerated approval pathway for this program as nicely? Thanks very a lot.
Doug Ingram — Chief Government Officer
So, answering the second query first. In the end, we — we’ll suggest a type of accelerated approval for 9003. That is an extremely, ultra-rare illness. We’re — the 9003 makes non-native protein, the absence of which is the only real and unique reason for the demise and in the end the loss of life of sufferers that undergo from 9003.
So, definitely, if we see nice ends in the confirmatory trial within the section 3 that we’re beginning, we’re going to suggest an accelerated approval pathway. As to the primary query, I am not going to supply numbers on — numbers of sufferers aside from to say our purpose is to deal with each affected person that is amenable to this remedy as rapidly as fairly potential. And so, we’re making ready ourselves to have a sturdy launch.
Operator
Thanks. Our subsequent query comes from the road of Gavin Clark-Gartner with Evercore ISI. Your line is now open.
Gavin Clark-Gartner — Evercore ISI — Analyst
Hey, thanks for becoming me in. Simply to observe up on the LGMD2E query, what’s your base case assumption for the section 3 main endpoint and trial design? When will you align with the FDA on this?
Doug Ingram — Chief Government Officer
So, the brief reply is we will begin that research earlier than the tip of this yr. We’ll align with the company on that alongside the best way. We have work to do there. Clearly, we have been prioritizing 9001 proper now.
The useful endpoint would possible be a type of NSAA, if I am not mistaken, it has been tailored for limb-girdle. However we’ll clearly even be taking a look at expression and security with respect to 9003.
Operator
Thanks. Our subsequent query comes from the road of Ritu Baral with TD Cowen. Your line is now open.
Unknown speaker
Hello, guys. That is [Inaudible] on for Ritu at present. Are you able to affirm the timing of EMBARK top-line knowledge? Have there be any adjustments to that? After which, any updates to your long-term income steering of $4 billion in 2025? How will you be revising this if 9001 is accredited this month?
Doug Ingram — Chief Government Officer
Our — our forecast assume approval this month. So, the reply with the primary query was —
Louise Rodino-Klapac — Government Vice President, Chief Scientific Officer
So far as the readout.
Doug Ingram — Chief Government Officer
There’s been no change within the EMBARK readout. The EMBARK was absolutely enrolled as of September of final yr. It is going swimmingly. It is clearly blinded.
So, it is being executed swimmingly and we anticipate high line actually on the finish of this yr, early subsequent yr.
Operator
Thanks. Our subsequent query comes from the road of Brian Skorney with Baird. Your line is open.
Brian Skorney — Robert W. Baird and Firm — Analyst
Hey, good afternoon. Thanks for taking my query. I assume form of leaping off on among the questions across the capacity to efficiently conclude EMBARK that you simply talked about, are you able to simply discuss to us about research conduct? And is there any danger that an accelerated approval may — may put research conduct in danger? , I believe you’ve got mentioned earlier than that the majority U.S. sufferers have truly had their final go to.
So, may you simply form of assessment what you’ll say to somebody questioning whether or not or not you had been going to have the ability to efficiently preserve research conduct on EMBARK upon getting commercially obtainable 9001 underneath AA?
Doug Ingram — Chief Government Officer
There isn’t any danger. Zero. The research was enrolled — absolutely enrolled September of final yr. The entire youngsters partially 1 of the research have obtained their doses.
The children on crossover are being dosed whilst we converse. Any child that has but to be dosed will probably be dosed within the subsequent few months, most. So, the march goes very nicely. We’ll learn out on time no matter whether or not we obtain accelerated approval.
There isn’t any — there is no affordable danger to that research.
Operator
Thanks. Our subsequent query comes from the road of Anupam Rama with J.P. Morgan. Your line is now open.
Anupam Rama — JPMorgan Chase and Firm — Analyst
Hey, guys, thanks a lot for taking a query. On SRP-9003, may you see any parts of the VOYAGENE knowledge this yr could also be beginning forward of the industrial materials section 3? I believe the PR solely dedicated to, like, enrollment completion however not knowledge itself doubtlessly, however simply questioning if we may see one thing this yr.
Doug Ingram — Chief Government Officer
Yeah, I am sorry — I am sorry for leaping in there, Anupam. We — it is not clear whether or not we would have knowledge this yr, so we’ll — we’ll replace you later within the yr on that.
Operator
Thanks. I might now like handy the convention again over to Doug Ingram for closing remarks.
Doug Ingram — Chief Government Officer
Properly, thanks, all, very a lot for becoming a member of us this night. And thanks on your questions and thanks for accommodating, you realize, my request that we not discuss concerning the regulatory course of or the advisory committee as a lot as you wish to ask questions on that and as a lot as I wish to reply questions on that if I will be sincere and direct with you. I look ahead to — clearly, all of us look ahead to Could 12. That advisory committee assembly is an unbelievably necessary second for sufferers residing with Duchenne.
I am terribly assured within the capacity of this crew to current the information nicely and to border it brilliantly, as I mentioned earlier than. After which I look ahead to coming again collectively thereafter and discussing the place we’re and the trail ahead. So, thanks, all. Have a beautiful night.
Operator
[Operator signoff]
Length: 0 minutes
Name members:
Mary Jenkins — Affiliate Director, Investor Relations
Doug Ingram — Chief Government Officer
Louise Rodino-Klapac — Government Vice President, Chief Scientific Officer
Dallan Murray — Senior Vice President, Chief Industrial Officer
Ian Estepan — Chief Monetary Officer
Colin Bristow — UBS — Analyst
Gena Wang — Barclays — Analyst
Brian Abrahams — RBC Capital Markets — Analyst
Judah Frommer — Credit score Suisse — Analyst
Salveen Richter — Goldman Sachs — Analyst
Gil Blum — Needham and Firm — Analyst
Tazeen Ahmad — Financial institution of America Merrill Lynch — Analyst
Danielle Brill — Raymond James — Analyst
Mike Ulz — Morgan Stanley — Analyst
Neena Bitritto-Garg — Citi — Analyst
Tim Lugo — William Blair and Firm — Analyst
Kristen Kluska — Cantor Fitzgerald — Analyst
Hartaj Singh — Oppenheimer and Firm — Analyst
Debjit Chattopadhyay — Guggenheim Companions — Analyst
Joseph Schwartz — SVB Securities — Analyst
Shu Zhiqiang — Berenberg Capital Markets — Analyst
Gavin Clark-Gartner — Evercore ISI — Analyst
Unknown speaker
Brian Skorney — Robert W. Baird and Firm — Analyst
Anupam Rama — JPMorgan Chase and Firm — Analyst
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