Provention Bio, Inc. (NASDAQ:PRVB) Q3 2022 Results Conference Call November 3, 2022 8:00 AM ET
Company Participants
Heidy King-Jones – Chief Legal Officer
Ashleigh Palmer – CEO and Co-Founder
Jason Hoitt – Chief Commercial Officer
Thierry Chauche – CFO
Conference Call Participants
Justin Kim – Oppenheimer
Chris Howerton – Jefferies
Ram Selvaraju – H.C. Wainwright
Thomas Smith – SVB Securities
Prakhar Agrawal – Cantor Fitzgerald
David Hoang – SMBC
Operator
Good morning. My name is Brandon, and I will be your conference operator for today. At this time, I would like to welcome everybody to the Provention Bio Third Quarter 2022 Financial Results Conference Call. [Operator Instructions]
I would now like to turn the conference over to Heidy King-Jones, Chief Legal Officer of Provention Bio. Please go ahead.
Heidy King-Jones
Thank you, operator, and thank you all for joining us. Ashleigh 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 Hoitt, our Chief Commercial Officer, who will highlight the status of our preparations in anticipation of teplizumab’s potential commercial launch as well as our co-promotion agreement with Sanofi. Thierry Chauche, 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 time lines 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 Factors section of our most recently quarterly report on Form 10-Q 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 and prevention reports we file with the SEC. These documents are available on Provention’s website at www.proventionbio.com under the Investors section. We encourage you to review these documents carefully.
With that, I will now turn the call over to Ashleigh.
Ashleigh Palmer
Thank you, Heidy, 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 III T1D in at-risk or Stage 2 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 17, 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 U.S. commercialization of what might soon become, if approved, the first ever disease-modifying therapy for at-risk T1D individuals with Stage 2 disease to delay the onset of clinical stage III 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 III PROTECT trial, evaluating teplizumab for new onset T1D our Phase IIa PREVAIL II 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 ordesekimab for nonresponsive celiac disease. We are also in discussions with prospective partners regarding the next stages of development for our polyvalent coxsackievirus B vaccine candidate, PRV-101.
With that, I would like to hand over to Jason.
Jason Hoitt
Thank you, Ashleigh We believe the commercialization team at Prevention Bio is well prepared for a potential FDA approval decision regarding teplizumab in Stage 2 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 6 to 9 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 to get enrolled in our co-pay assistance program. We have 8 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 health care 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 17. 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 6, that we’re combining forces with Sanofi to co-promote teplizumab, if approved, the core commercial and medical affairs leadership teams from Sanofi and Provention have been meeting to ensure that we’re ready to go under the terms of the co-promotion agreement. We will 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 team 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 teplizumab, 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 of Pediatric and Adolescent diabetes conference a few weeks ago, alongside a few colleagues from Provention. And I have to say there was palpable excitement about the potential for teplizumab among many of the health care 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?
Thierry Chauche
Thank you, Jason. Before I begin discussing the third quarter financials, I would encourage you to read our 10-Q that was filed today. The 10-Q includes our financial statements, risk factors as well as management’s 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 million 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 third quarter of 2021.
Our 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 cost for teplizumab program, 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 ordesekimab and PREVAIL IIa trial for PRV-3279. 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 recognized $0.8 million of collaboration revenue under our license agreement with Huadong, our cash-based operating expenses for the first quarter of 2022 were $26.4 million, which excludes noncash 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 30, 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 nonrefundable 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 30 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 14% premium to the 5-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 ordesekimab and PRV379 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 will 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 nonresponsive celiac disease expected at the end of 2023.
As a reminder, Provention 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 overall activity with respect to ordesekimab. Finally, we believe our momentum with a potential FDA approval of teplizumab in November provides us with optionality to take care of 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 Ashleigh.
Ashleigh Palmer
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 health care 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 Provention 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 2 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.
Question-and-Answer Session
Operator
[Operator Instructions] Our first question comes from Justin Kim with Oppenheimer.
Justin Kim
Great to hear that the company has conducted sort of the expected proposed labeling and post-marketing considerations associated with the filing. But 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 teplizumab with the potential launch?
Ashleigh Palmer
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?
Jason Hoitt
Yes. Justin, thanks for the question. Really no change as far as we’re concerned. We’ve completed, as I’ve mentioned previously on calls, our pricing research. 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 our potential approval. As I’ve mentioned before, though, the feedback that we’ve been hearing from payers over the last 3 nearly 3 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.
Justin Kim
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. I’m just wondering, are there specific studies that the team is sort of excited to maybe speak more to or initiate even upon a potential approval?
Thierry Chauche
Yes. Thank you, Justin. So yes, we are excited if we’re fortunate enough to get approval to focus on patients below 8 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, B2 cell transplantation.
We’re excited about the prospect of evaluating teplizumab on stage earlier than Stage 2 at-risk patients, individuals at Stage 1 who have just 2 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.
Operator
Your next question comes from Chris Howerton with Jefferies.
Chris Howerton
I’m very excited to hear that you have the proposed label. So I guess the 2 questions that I have for me is, first, with respect to the post-marketing requirements, could you give us any color on what those might be, any additional clinical work that could be required that you’re expecting? That’s question one.
And then question two, 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.
Ashleigh Palmer
Thanks, Chris. 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 PK/PD study in patients under 8 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 PROTECT study and the right of first negotiation, our guidance has been that we anticipate the top line results from the PROTECT 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.
Chris Howerton
Got it. So they essentially, just to clarify, Ashleigh and I appreciate that, is that the Sanofi 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?
Ashleigh Palmer
That’s correct.
Chris Howerton
Again, congratulations.
Ashleigh Palmer
Thank you, Chris.
Operator
Your next question comes from Ram Selvaraju with H.C. Wainwright.
Ram Selvaraju
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 Provention and Sanofi in preparation for the launch of teplizumab. And if you could also give us a sense of whether there has been any specific updates or revisions to this in the context of the label?
Ashleigh Palmer
Thanks very much for the question, Ram. So I hand over to Jason, who has been working very hard with our colleagues in Sanofi in preparation and planning. Jason?
Jason Hoitt
Yes. Thanks for the question, Ram. So with respect to specific marketing activities, as I mentioned in the prepared remarks, our 8 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 health care 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 RTM disproportionately focuses on the pediatric endocrinology segment of the market.
Now with that being said, there will be some redundancy in some complex accounts and some centers of excellent 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 2 teams. I would say that now that we have 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. I hope that answers your question, Ram.
Ram Selvaraju
Yes, very much. So just very quickly on the 101 drug candidate. 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.
Jason Hoitt
Thanks very much Ram. So we feel that, that asset is best advanced by a party that has a vaccine franchise, and we’ll be able to do the advanced stages of development and the commercialization of that. So we’re actively seeking that profile of a 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.
Operator
Your next question comes from Thomas Smith with SVB Securities.
Thomas Smith
Congrats on all the progress. Maybe just starting on the ongoing BLA review. I appreciate the comments around the proposed labeling and the post-marketing requirements. It sounds like things are progressing really nicely there. Actually, can you just remind us whether there’s anything outstanding you’re gaining from your perspective on sort of the manufacturing or CMC side?
Ashleigh Palmer
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.
Thomas Smith
Okay. Got it. And then 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? Don’t you, Jason?
Jason Hoitt
Yes. Thanks for the question, Tom. What we’ve said previously is that given this market, we don’t anticipate commercial contracting. So any time we’re launching with a medical benefit, it’s going to take time to implement those 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 they’re 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 it just requires a 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.
6 to 9 months is general guidance, some can be quicker. But generally, that’s about the right time frame for policies to officially be put in place on the payer side. I hope that answers your question, Tom.
Thomas Smith
Okay. Got it. Yes, that’s super helpful. 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?
Ashleigh Palmer
Yes. Thanks, Tom. So generally, we’ve advised in the past that the submission in Europe and the U.K. is approximately 12 months or so behind an approval here in the United States. So 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 have secured with us is with respect to teplizumab for type 1 diabetes on a global basis. And so we anticipate that these 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.
Thomas Smith
Congrats on the progress.
Operator
Your next question comes from Prakhar Agrawal with Jones Trading.
Prakhar Agrawal
This is Prakhar from Cantor. Congratulations on getting the proposed label, Ashleigh 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.
Ashleigh Palmer
Thank you very much, Prakhar 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 patients with 2 autoantibodies T1D autoantibodies and dysglycemia defining a Stage 3 patient.
Patients who are over 8 years of age. And we’ve prided in the past that we hope the agency does not constrain the use of teplizumab to only patients with familial relatives with existing type 1 diabetes. And so 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.
Prakhar Agrawal
Okay. And secondly, on the Phase III PROTECT trial, how important is this trial readout for likely partners as they make the decision on global out-licensing deal? 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? Congratulations.
Ashleigh Palmer
Thank you, Prakhar. So as mentioned earlier, the right assess negotiation expires in June of next year with respect to 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 that 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 and new onset patients of assuming that we have been successful in securing the approval of teplizumab for at-risk patients.
Operator
Your next question comes from David Hoang with SMBC.
David Hoang
Congrats on all the progress. Really great to see teplizumab be close to the finish line here and looking forward to the PDUFA date. So I just had a couple of questions. Just first, in terms of the early launch period, thing we do get approval soon and you’re able to meet the time lines 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 dosed site offering treatment just those sorts of things.
Ashleigh Palmer
Thanks, David. So yes, I’ll hand that question over to Jason. But as you’ll appreciate, this is a nascent market and a somewhat disruptive therapeutic intervention into a space that has historically no therapeutic options. So we have to be very cautious as to how we assess the progress in the early stages, but we do have, obviously, metrics that we will be using to track, Jason?
Jason Hoitt
Thanks for the question. So obviously, internally, we’re going to be tracking a multitude of different metrics to track launch progress and anticipate 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 health care providers and core stakeholder audiences that we know are imperative during the launch. In addition to that, every launch is a bit unique. Every launch is a little bit different.
And so 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 at demonstrating launch progress.
David Hoang
Yes. Okay, I see. That’s helpful. And then I just had a question on the coverage and reimbursement front with payers. I 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? Is that something they can contribute to as part of the co-promotion agreement? Or is that kind of well in hand just with prevention scheme and your own efforts in that regard?
Ashleigh Palmer
Jason?
Jason Hoitt
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.
Operator
Your next question comes from Gregory Renza with RBC Capital Markets.
Unidentified Analyst
It’s Anish [ph] on for Greg. First of all, congrats on the quarter. Just wanted to get your take on the macro/clinical landscape. From your perspective, when do you expect in-office patient visits to return to prepandemic levels? And with this in mind, what are your screening expectations for at-risk to UMB for the teplizumab program?
Ashleigh Palmer
Thank you for the question. Jason, do you want to take that one?
Jason Hoitt
Yes, it’s a great question. And 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, auto antibody assays are readily available through commercial labs like LabCorp and Quest. We know through data available on Quest Labs or I’m sorry, 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 0.
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 against the backdrop of a global pandemic, I think JDRF launching this program nearly 2 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.
Operator
Ladies and gentlemen, this concludes our question-and-answer question. I would like to turn the conference back over to Ashleigh Palmer for any closing remarks.
Ashleigh Palmer
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.
Operator
The conference has now concluded. Thank you for joining today’s presentation. You may now disconnect.
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