Provention Bio, Inc.

Good morning. My name is Raman, and I will be your conference operator for today. At this time, I would like to welcome everybody to the Prevention Value Third Quarter 2022 Financial Results Conference Call. All participants are in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Start key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press star, then 2. Please be advised that this call is being recorded at the company's request. I would now like to turn the conference over to Heidi King-Jones, Chief Legal Officer of Prevention Bio. Please go ahead.

Thank you, Operator, and thank you all for joining us. Ashley Palmer, Chief Executive Officer and co-founder of Prevention Bio, will first provide an update on our third quarter regulatory interactions and corporate progress before turning the call over to Jason Hoyt, our Chief Commercial Officer, who will highlight the status of our preparations in anticipation of teplizumab potential commercial launch, as well as our co-promotion agreement with Sanofi. Gary Chauchet, our Chief Financial Officer, will then provide a summary of our third quarter financial results, as well as an update on our strategic financing activity. Before we begin, let me remind you that the various remarks we will make today constitute forward-looking statements. These include statements about our future plans and expectations in connection with the agreements we entered into with Sanofi and the potential commercialization of teplizumab, clinical study results, regulatory and other developments, and timelines related to our product candidates, including our plans to continue working with the FDA as they review our BLA resubmission and continuing our efforts towards securing a potential FDA approval for and commercialization of teplizumab for an at-risk indication. the potential safety, efficacy, and commercial success of teplizumab and our other product candidates, financial projections, including our anticipated use of cash and our cash runway, and our business plans and prospects and projected timing for the same. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our most recently quarterly report on Form 10Q and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change, except as required by law. Therefore, you should not rely on these forward-looking statements as representing our views as of any subsequent date to today. There is more complete information regarding forward-looking statements, risks and uncertainties in prevention reports we file with the SEC. These documents are available on prevention's website at www.preventionbio.com under the Investors section. We encourage you to review these documents carefully. With that, I will now turn the call over to Ashley.

Thank you, Heidi, and good morning, everyone. Throughout the third quarter, our team has continued to interact with the FDA in support of our resubmitted breakthrough therapy-designated teplizumab BLA for the delay of clinical type 1 diabetes, or stage 3 T1D, in at-risk or stage two individuals. In the major amendment notice we received at the end of June, the FDA informed us that if no major deficiencies were identified during its review, the agency planned to communicate proposed labeling and post-marketing requirements and commitments by October 17th, 2022. I am pleased to report that we have since received both the FDA's proposed labeling and the FDA's proposed post-marketing requirements and commitments and that these are generally consistent with our expectations and public market guidance to date. Our timely receipt of the FDA's proposed labeling and post-marketing requirements and commitments is encouraging. Nevertheless, we must caution that the FDA has yet to make its final decision regarding the BLA and there is always a possibility circumstances can change as the agency continues to review our application. In parallel with our ongoing FDA interactions, we have also been collaborating closely with our co-promotion partner Sanofi in preparing for the potential US commercialization of what might soon become, if approved, the first ever disease modifying therapy for at-risk T1D individuals with stage two disease to delay the onset of clinical stage three insulin dependency. Under our agreement with Sanofi, Prevention continues to maintain control over all aspects of regulatory and commercial strategy for the potential launch of teplizumab, including labeling negotiations, packaging, distribution, and pricing. Before handing the call over to Jason to further discuss our launch planning and preparations in anticipation of teplizumab's potential approval, Let me also mention that throughout the third quarter, our team has continued to make steady progress across all our autoimmune disease-focused clinical development programs. This includes our Phase 3 PROTECT trial, evaluating teplizumab for new onset T1D, our Phase 2a PREVAIL-2 trial, evaluating PRV-3279 for systemic lupus erythematosus, and in partnership with Amgen, our Phase IIb proactive trial, evaluating our anti-IL-15 monoclonal antibody, or disecumab, for non-responsive celiac disease. We are also in discussions with prospective partners regarding the next stages of development for our polyvalent Coxsackievirus B vaccine candidate, PRV101.

With that, I would like to hand over to Jason.

Thank you, Ashley. We believe the commercialization team at Prevention Bio is well prepared for a potential FDA approval decision regarding teplizumab in stage two at-risk T1D individuals. Our Compass Navigator team will be ready to start receiving and processing enrollment forms on the day following approval. In parallel, our Field Market Access team will work with payers on getting medical policies developed in support of coverage for teplizumab, which we expect will take six to nine months. In the early days of launch, we anticipate working through the medical exception process for insurance coverage. and compliantly helping eligible, commercially insured patients get enrolled in our co-pay assistance program. We have eight therapeutic specialists on board as a part of our pilot sales team initiated more than a year ago. These team members will be in the field soon after approval to start educating physicians at major centers of excellence and responding to unsolicited requests for education from healthcare providers. As I've mentioned on previous calls, We were in excellent shape with respect to launch readiness over the summer when we received notice of the delay in FDA review. We have fully reinitiated all activities related to launch readiness and are prepared for November 17th. Educational materials, contracting with key distribution partners, core communication work streams, and hiring are on track for our FDA action date. We're pleased to announce that conditional offers to join us have been accepted by the majority of our planned sales force. and we plan to onboard them during the month of December, contingent upon FDA approval. Since our announcement on October 6th that we're combining forces with Sanofi to co-promote teflizumab if approved, the core commercial and medical affairs leadership teams from Sanofi and Prevention have been meeting to ensure that we're ready to go under the terms of the co-promotion agreement. We'll be doing some additional recruitment over the next few weeks for the remaining field-based positions and continue to be on track to deploy both our teams and our new colleagues from Sanofi in the early part of January. This planned additional headcount from Sanofi sets the stage nicely for the commercial launch of Tiplizumab, and we remain excited about our progress during this initial ramp-up. We will be conducting joint training programs with the prevention and Sanofi teams in December and expect full deployment of the entire team into the field in January. Finally, it's worth mentioning that I had a chance to attend the International Society for Pediatric and Adolescent Diabetes Conference a few weeks ago, alongside a few colleagues from prevention. And I have to say, there was palpable excitement about the potential for teplizumab among many of the healthcare providers with whom we interacted at the meeting. Our symposium at the Congress was standing room only and ran nearly 30 minutes over time with questions from the audience. We look forward to working closely with physicians, patients, advocacy organizations, and others to bring this important new treatment to market pending our potential receipt of FDA approval. I'd now like to turn the call over to Thierry to discuss our financials. Thierry?

Thank you, Jason. Before I begin discussing the third quarter financials, I would encourage you to read our thank you that was filed today. The thank you includes our financial statements risk factors, as well as management discussion and analysis of our financial condition. I would also like to call your attention to the earnings press release, which was issued prior to this call. Let me start with the P&L. We generated a net loss for the third quarter of 2022 of $28.6 billion, or $0.34 per basic and diluted share. compared to a net loss of $27 million, or $0.43 per basic and diluted share, for the first quarter of 2021. R&D expenses were $16.3 million for the third quarter of 2022, compared to $17.7 million during the same period in 2021. The decrease year-over-year was driven by lower costs for Teplizumab programs, including the PROTECT study as target enrollment was reached in August of 2021. This decrease was partially offset by increased costs associated with the enrollment of the proactive trial for odesicumab and prevailed 2A trial for PRV3279. G&A expenses were $13.5 million for the third quarter of 2022 compared to $10 million during the same period in 2021, driven by an increase in our pre-commercial activities. During the third quarter, we also recognize $0.8 million of collaboration revenue under our license agreement with Wadong. Our cash-based operating expenses for the third quarter of 2022 were $26.4 million, which excludes non-cash stock-based compensation of $3.3 million and depreciation expense of $0.1 million. This number came slightly below the lower end of our guidance, driven by our cautious approach to expenses and cash management. Turning now to our current cash position and cash projection. As of September 30th, 2022, our cash, cash equivalent and marketable securities position was $186.5 million. This includes the net proceeds of $57.2 million from our private placement completed in July, $23.7 million from the first tranche of our term loan facility with Hercules, as well as $33.6 million raised through our at-the-market program during the third quarter of 2022. We currently have just over $100 million of available capacity on our at-the-market program, and we will continue to be opportunistic regarding the use of this program. In October, under our co-promotion agreement with Sanofi, we received the $20 million non-refundable payment from Sanofi for the right of first negotiation exercisable through June 2023 to research, develop, manufacture, and commercialize teplizumab globally in T1D. This $20 million payment is not included in the cash figure as cited for September 30th and will be reflected in the fourth quarter financial results. If teplizumab is approved by the FDA under our securities purchase agreement, Sanofi will purchase $35 million of prevention common stock at a 40% premium to the five-day volume weighted average price prior to the closing date, with this closing date being at our discretion, but no later than February 16, 2023. In addition, we will have the ability to draw the next tranche under our term loan facility, totaling $40 million. Based on our current business plan, we believe that our current cash, cash equivalents, and marketable securities on hand, together with capital from Sanofi and Hercules, that is contingent on approval, enables us to support a successful commercial launch of teplizumab, if approved, and provides us with a cash runway through 2023. Please note that this guidance could be changed by the level of success of our potential commercial launch, changes to estimated cost of commercialization, including our commitments under the Sanofi Co-promotion Agreement and potential milestone payments. We continue to be prudent and gated in our spending as we work towards the potential approval of teplizumab, and we expect our cash-based operating expenses to be between $40 million and $45 million in the fourth quarter of 2022, reflecting an increase in program spend for odesicumab and PRV3079 as well as preparation for the potential commercial launch of teplizumab, assuming FDA approval in November. In a scenario where the approval for teplizumab is not obtained from the FDA in November, we estimate that our cash runway would extend through 2024, which is beyond the top-line data readout from our Phase III PROTECT trial in newly diagnosed T1D, which is currently expected in the second half of 2023, as well as after the completion of our proactive Phase IIb study in non-responsive celiac disease expected at the end of 2023. As a reminder, prevention is eligible to receive a $150 million milestone payment from Amgen within 120 days after the delivery of the final data package for the proactive trial should Amgen elect to exercise its right to assume control over all activities with respect to all the taken maps. Finally, We believe our momentum with the potential FDA approval of teplizumab in November provides us with optionality to secure additional capital, and we will continue to be both strategic and opportunistic when evaluating potential financing activities, as evidenced by our most recent transactions. With that update, I will now turn the call over to Ashley.

Thank you, Thierry.

Our corporate mission and the strategic intent of our disruptive conceptual platform and clinical stage programs remains firmly focused on catalyzing a paradigm shift in how our industry and healthcare systems manage serious life-threatening and debilitating autoimmune diseases. We hope this becomes a reality in the near future with the potential approval of teplizumab for at-risk individuals with stage 2 T1D. In closing, I would like to thank the prevention team and the FDA for all their hard work to bring teplizumab as a breakthrough designated therapy to this late stage in the agency's review process. We hope to receive a positive decision in the coming weeks and, if approved, plan to quickly and effectively bring what would then be the first ever at-risk stage two disease modifying therapy to the T1D community and the precious patients, families, caregivers, and clinicians we serve.

With that, operator, we would like to open the call for questions.

Thank you.

We will now begin the question and answer session. To ask a question, please press star, then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the key. To withdraw your question, please press star, then 2.

At this time, we will pause momentarily to assemble our roster. Our first question comes from Justin Kim with Open Timer.

Please go ahead.

Hi, good morning, and thanks for taking the questions. Great to hear that the company has conducted sort of the expected proposed labeling and post-marketing considerations associated with the filing. But, you know, just wondering, have you conducted any of the sort of discussions with payers in terms of pricing. And do you have any updates or any changes to how you've been thinking about pricing for Tefliz and that with the potential launch?

Good morning, Justin. Thank you for the question. So I'll hand that over to Jason, who has been taking full advantage of the additional review time as a result of the amendment we received at the end of June. Jason?

Yeah. Good morning, Justin. Thanks for the question. Really no change as far as we're concerned. You know, we've completed, as I've mentioned previously on calls, our pricing research. You know, we haven't set that final price yet and don't intend to until we have a final label locked. And we would anticipate announcing that final price at the time of a potential approval. You know, as I've mentioned before, though, you know, the feedback that we've been hearing from payers over the last three, nearly three years, has been really consistent. Payers have told us they anticipate covering teplizumab with a streamlined prior-off-to-label, which is precisely the strategy we're hoping to achieve.

Okay, great, great. And maybe just sort of setting aside the discussions with the FDA on post-marketing commitments, I know we've talked sort of in the past about additional studies to broaden the use of teplizumab even beyond sort of protect, and just wondering, you know, Are there specific studies that the team is sort of excited to speak more to or initiate even upon a potential approval?

Yes, thank you, Justin. So, yes, we're excited. If we're fortunate enough to get approval to focus on patients below eight years of age to expand labeling into the younger population, we're excited about the prospect of redosing studies to determine whether additional dosing, additional courses of therapy could extend the delay seen from a single course of therapy. We're excited about the prospect of co-administration of teplizumab with cellular therapies, beta cell transplantation. We're excited about the prospect of evaluating teplizumab one stage earlier than stage 2 at-risk patients, individuals at stage 1 who have just two autoantibodies. And beyond that, we're excited to explore teplizumab's potential outside of type 1 diabetes, targeting other T-cell-mediated autoimmune diseases such as celiac disease.

Great, great. Thanks so much and, you know, looking forward to continued progress later this month.

Thank you. Your next question comes from Chris Halberton with Jefferies.

Hey, good morning. Thank you so much for taking the questions and I'm very excited to hear that you have the proposed label. Um, so I guess the, the two questions that I'd have for me is, um, first, if with respect to the post-marketing requirements, um, could you give us any color on what those might be? Any additional clinical work that could be required that you're expecting? Um, that's question one. And then question two, um, we've, I've had some confusion, I think both with myself and potentially with investors in terms of. when we might get the protect data and when the period of the right of first negotiation requires, expires, excuse me. So if you could just clarify kind of how the protect data might factor into that period, that would be great. Thank you.

Thanks, Chris. Good morning. So regarding PMCs and PMRs, as I said in my script, we have received them, and they are consistent with our prior guidance to the public markets. So to clarify, our public market guidance historically has been to conduct a pediatric safety study and PKPD study in patients under eight years of age, as well as to set up a registry to evaluate long-term safety. And I think that the proposed post-marketing commitments, post-marketing requirements are consistent with that. But as I also mentioned in the opening statement, it's not final and the agency can change its mind at any time. Regarding the pro-tech study and the right of first negotiation, our guidance has been that we anticipate the top line results from the pro-tech study being available in the second half of next year. We have announced that the right of first negotiation expires in the end of June of next year. But we've also stated that Sanofi can extend that right of first negotiation based on an additional payment. And that could potentially coincide with evaluating the top line results of PROTECT.

Got it. So they essentially, just to clarify, Ashley, and I appreciate that, is that the Santa Fe could make an additional payment to extend that negotiation period, which would then encompass that you're anticipating the top line results. Do I have that correct?

That's correct.

Okay.

All right. Well, thank you very much. I appreciate you taking the questions. And again, congratulations.

Thank you, Chris.

Thank you. Your next question comes from Ram Sohoraju with HC Wainwright.

Thanks so much for taking my questions. I was just wondering if you could comment a little bit on how you see the specific marketing activities being planned out and allocated across prevention and Sanofi in preparation for the launch of Diplizumab And if you could also give us a sense of whether there have been any specific updates or revisions to this in the context of the label.

Thanks very much for the question, Ram. Good morning. So, I hand over to Jason who has been working very hard with our colleagues in Sanofi in preparation and planning. Jason.

Yeah, thanks for the question, Ram. So with respect to specific marketing activities, you know, as I mentioned in the prepared remarks, our eight therapeutic specialists that have been in the field for just over a year now, we anticipate deploying shortly after a potential approval to start educating centers of excellence and reactively responding to healthcare providers who reach out, seeking more information on the efficacy and safety of teplizumab and how to go about acquiring and infusing teplizumab. As I mentioned, the things have been progressing incredibly well with our new colleagues at Sanofi in terms of that joint deployment, the joint training that will start in early December with the anticipated deployment of both teams in the early part of January. Now, with that being said, as we mentioned when we announced the co-promotion agreement with Sanofi, they're deploying a number of dedicated account directors that will disproportionately be focusing on the adult endocrinology segment of the market, while our team disproportionately focuses on the pediatric endocrinology segment of the market. Now, with that being said, there will be some redundancy and some complex accounts in some centers of excellence, academic institutions, to raise that level of awareness. And we feel that with the nearly doubling of the field presence through our new colleagues at Sanofi, we should be able to really accelerate that level of awareness around a potential approval with the joint deployment in the early to middle part of January of the two teams. I would say that, you know, now that we've seen draft labeling from the FDA, it really only validates the approach that we're taking with Sanofi, so no changes to our anticipated deployment or marketing activities as a result of the labeling discussions that are ongoing.

Hope that answers your question, Rahm.

Yeah, very much so. Just very quickly on the 101 drug candidates. I was wondering if you had any updated thoughts regarding the overall strategic positioning of this asset in the context of the commercial availability of teplizumab and ultimately what you think would be the most beneficial or favorable strategic outcome with respect to that asset as you look to position it most appropriately.

Thanks very much, Ram. So we feel that that asset is best advanced by a party that has a vaccine franchise and will be able to do the advanced stages of development and the commercialization of that. So we're actively seeking that profile of partner. We don't really anticipate that there is any conflict between the PRV-101 asset and the positioning of teplizumab for at-risk or new-onset type 1 diabetes in the near to medium-term future.

Thank you. Thank you. Your next question comes from Thomas Smith with FDB Security.

Hey, guys. Good morning. Thanks for taking the questions, and congrats on all the progress.

Hey, just starting on the ongoing DLA review. Appreciate the comments around the proposed labeling and the post-marketing requirements. Sounds like things are progressing really nicely there. Ashley, can you just remind us whether there's anything outstanding or gating from your perspective on sort of the manufacturing or CMC side?

Yes. Good morning, Tom. Thank you. Yes. As we had indicated based on the agency's prior decision back at the original PDUFA date, there were outstanding manufacturing questions that the agency had, which we believe we've addressed in the resubmitted BLA. And we can anticipate that there will be the prospect of post-marketing commitments and requirements in regards to advancing the manufacturing process and related assays and so on in the event of a favorable decision by the agency.

Okay, got it.

And then I just want to follow up on the commercial front and the market access here. It sounds like you're expecting some of the payer policies could take some time to implement. I was wondering if, Jason, if you could just talk to sort of the tone and goals of some of your recent payer engagement. Is it possible you could have some value-based agreements already in place at the time of launch that could maybe streamline reimbursement?

Thank you, Jason. Yeah, thanks for the question, Tom. You know, what we've said previously is that given this market, we don't anticipate commercial contracting. So, you know, anytime we're launching with a medical benefit, it's going to take time to implement the medical policies across the payer audience. And so our market access directors are going to be working very closely with medical directors and payers across the board to ensure that, you putting in place medical policies to support reimbursement of teplizumab. Now, that doesn't mean that while those policies are being drafted, patients don't have access. It just means that they'll be working through the medical exception policy. And many, if not most, medical benefit products are covered by medical exception initially until a policy is put in place. It sounds like it's a big hurdle, but oftentimes this can be relatively quick and easy. Not all of the time, but You know, it just requires the physician to go through a little bit more work and write that letter of medical necessity on behalf of the patient in those early days. Six to nine months is general guidance. Some can be quicker. But generally, that's about the right timeframe for policies to officially be put in place on the payer side. I hope that answers your question, Tom.

Okay, got it. Yeah, that's super helpful. Thanks, Jason. And then just maybe... Lastly, if you could just remind us or give us an update on kind of the status of the teplizumab discussions in Europe and with the MHRA and what you think the path forward might look like in that region.

Yes, thanks, Tom. So generally, we've advised in the past that the submission in Europe and the UK is approximately 12 months or so behind an approval here in the United States. So, you know, right now our focus is on getting teplizumab through the final stages of review and hopefully approved by the FDA, launched effectively with our co-promotion partner, Sanofi. And of course, the right of first negotiation, which Sanofi has secured with us is with respect to teplizumab for type 1 diabetes on a global basis. And so we anticipate that if ongoing discussions and negotiations with Sanofi under a right of first negotiation are successful, that bringing a partner like Sanofi into play with respect to international market regulatory submissions and potential commercialization would be a very significant development.

Got it.

That makes sense. All right, guys. Appreciate the updates and congrats on the progress. Thank you. Your next question comes from with Jones Trading.

Hi, this is Prakhar from Cantor. Congratulations on getting the proposed label, Ashley and team. It's been a long road for you on the regulatory front, but it seems that you're close to the finish line, so congrats. So my first question is if you could remind us on the base case expectations around the label. What are the key points of negotiation with the FDA? And also at this stage, do you expect any kind of black box? And I had a quick follow-up. Thank you.

Thank you very much, Prakash. So, as I mentioned in the opening remarks, the proposed label from the FDA is materially consistent with that we've provided historic guidance on. Again, a reminder that historic guidance is that the label will generally follow the enrollment criteria. of the TN10 study, so that's patients with two autoantibodies, T1D autoantibodies, and dysglycemia, defining a stage 2 patient, patients who are over eight years of age. And we've guided in the past that we hope the agency does not constrain the use teplizumab to only patients with familial relatives with existing type 1 diabetes. And so, you know, my opening remarks indicated that the proposed label is consistent with that. And since the historic guidance has not been with respect to an expectation regarding a black box, then that would also be consistent with historic guidance.

Okay, thank you. And secondly, on the phase three PROTECT trial, how important is this trial readout for likely partners as they make the decision on global out licensing view? And also, if you could remind us from a regulatory standpoint, is hitting the primary endpoint enough or you have to hit on secondary endpoints as well? If yes, how many? And which ones will be the most important? Thank you and congrats again.

Thank you, Prakash. As mentioned earlier, the right of first negotiation expires in June of next year with respect to our partnership with Sanofi, but there is the prospect of Sanofi extending that right of first negotiation into the second half of 2023 when we've guided the top line results of the PROTECT study will be available. In terms of the PROTECT study readout and the primary endpoint versus secondary endpoint, we'll update the market as we get closer to the top line results and our discussions with the FDA then focus on that study. new onset patients as assuming that we have been successful in securing the approval of teplizumab for ATLAS patients.

Thank you. I appreciate the update. Thank you. Your next question comes from David Hoang with FMBC.

Hey, thanks for taking the questions and congrats on all the progress. Really great to see teflizumab be close to the finish line here and looking forward to the PDUFA date. So I just had a couple questions. Just first in terms of the early launch period, assuming we do get approval soon and you're able to meet the timelines you specified for commercial launch, Can you just talk a little bit about what types of metrics and kind of color you plan to give to help investors just gauge the progress of the early launch, whether that be patients, those sites offering treatment, just those sorts of things?

Thanks, David. So, yeah, I'll hand that question over to Jason. But as you'll appreciate, this is a nascent market and a somewhat disruptive market. therapeutic intervention into a space that has historically no therapeutic options. So, we have to be, you know, very cautious as to how we assess the progress in the early stages, but we do have, obviously, metrics that we'll be using to track. Jason?

Yeah, good morning, David. Thanks for the question. Obviously, internally, we're going to be tracking a multitude of different metrics to track launch progress and anticipated launch success. Typically, in launches, I'm always going to want to provide you guys with activity metrics that demonstrate the robust activity of the team and engaging healthcare providers and core stakeholder audiences that we know are imperative during a launch. In addition to that, You know, every launch is a bit unique. Every launch is a little bit different. And so, you know, while I can't give you the specific metrics that we'll disclose in the early phases of launch today, the reason why is because I'm not specifically sure which metrics are going to paint that picture for you of how the launch is going. And so my anticipated intent is to provide you with metrics that paint both a quantitative and qualitative picture of how the launch is going so that you can assess how we're doing in the market over time. But I can't tell you today specifically what those quantitative and qualitative metrics are that paint that picture for you of how the launch is progressing. I know that's not a specific answer to your question, but it at least provides you with the intent of how we're anticipating demonstrating launch progress.

Yeah, okay. I see. That's helpful. Thanks for that. And then I just had a question on the, you know, the coverage and reimbursement front with payers. I know, you know, you guys have been driving that process. Just curious as to whether you feel Sanofi could lend any support in terms of market access or your conversations with payers, you know, is that something they can contribute to as part of the co-promotion agreement or, you know, is that kind of well in hand? just with prevention team and your own efforts in that regard.

Jason?

Yes, absolutely, is the answer to the question, David. One of the field-based teams that is a part of the co-promotion agreement is the market access team, the values and outcomes team. And so we will actively be partnering with Sanofi on market access and field-based reimbursement as well.

Okay, that's great to hear. Thanks for taking the questions. Thank you.

Your next question comes from Gregory Urenza with RBC Capital Markets.

Hey guys, it's Anish on for Greg. First of all, congrats on the quarter and thanks for taking my question. Just wanted to get your take on the macro slash clinical landscape. From your perspective, when do you expect in-office patient visits to return to pre-pandemic levels? And with this in mind, what are your screening expectations for at-risk T1D for the TiplizMAP program? Thanks so much.

Thank you for the question. Jason, do you want to take that one?

Yeah, it's a great question. And, you know, I think in-office patient visits have already recommenced post-pandemic from what we're hearing in the field. And with respect to screening, I think it's a great question. I think there are multiple different ways that a patient can go about getting screened today. As we've mentioned during previous calls, autoantibody assays are readily available through commercial labs like LabCorp and Quest. We know through data available on LabCorp's website that 98% of patients in their database have an out-of-pocket cost associated with an autoantibody panel of $25 or less, and 65% have an out-of-pocket of zero. So not only is the test available, the test is reimbursed. There are also at-home options supported by JDRF and their T1 Detect program. So patients that are less inclined to go for an in-person physician visit can order a test kit from the comfort of their own home through T1 Detect and have an autoantibody panel conducted from the comfort of their kitchen table, which you know, against the backdrop of a global pandemic. I think JDRF launching this program nearly two years ago was really well-timed. But we anticipate patients being able to get screened and being able to get in to see their physician in person as we potentially roll this drug out in the early part of next year.

Great. Thank you so much. Congrats on all the progress.

Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Ashley Palmer for any closing remarks.

Well, thank you, operator, and thank you all for joining today. We look forward to keeping you updated in the coming weeks.

Please enjoy the rest of your day. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.