Q2 2020 BioNTech SE Earnings Call
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Thank you for standing by welcome to the point in Tech second quarter 2020 operational progress I'm financial results Cool I.
At this time, all participant solving it isn't only mileage.
We'll be a presentation followed by a question announce a session I must advise you to school is being recorded today Tuesday, the 11th to focus 2020.
I would like to have the core over to the Vice President Investor Relations business drugs, Jay So combos. Please go ahead.
Thank you for joining us today held by on Craig's second quarter Twentytwenty update call.
Before we stock we encourage you to view the flight for the what caused it.
Operationally financially Besides press release issued this morning, both of which accessible on our website under Investor section.
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As shown on slide two during today's presentation will be making several for what's your PC.
These forward looking statements in cute, but they're not limited to the timing off in government initiation Competion reporting data from our clinical trials.
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The potential registrational nature of certain clinical trials.
Impact the cobot pandemic, when our business and financial outlook.
The timing for any potential emergency use authorization approved for BNP onesix too.
The potential safety and efficacy of BMT once it's too.
The ability of biotech to supply the quantities BMP onesix too to support clinical development and if approved market demand, including our production estimates put twentytwenty and Twentytwenty one.
Actual results could differ from those we currently anticipate you are therefore caution not to place.
Unknown Executive: to the response of laser linebackers. Thank you for standing by, and welcome to the BioNTech Second Quarter 2020 Operational Progress and Financial Results Call. At this time, all participants are in a listen-only mode. There will be a presentation followed by a question and answer session. I must advise you this call is being recorded today, Tuesday 11th August 2020, and I would now like to hand the call over to the Vice President, Investor Relations and Business Strategy, Silke Maas. Please go ahead.
Undue reliance on any forward looking statements, which speak only as of the date This conference call and what cost.
Speaking at the available for questions today with the with nine Chief Executive Officer Islam glad she chief Medical Officer.
All merit.
<unk> business and commercial officer.
Putting chief financial and operating officer, and find Richardson Chief strategy Officer.
I now hand, the call over with line bound picks C O.
Unknown Executive: Thank you for joining us today for BioNTech's second quarter 2020 update call. Before we start, we encourage you to view the slides for the webcast as well as the operational and financial results press release issued this morning, both of which are accessible on our website in the investor section. As shown on slide two during today's presentation, we will be making several forward-looking statements, including, but not limited to, the timing of enrollment, initiation, completion, and reporting of data from our clinical trials, the potential registrational nature of certain clinical trials, the impact of the COVID pandemic on our business and financial outlook, the timing of any potential emergency use authorizations or approvals for BNT162, the potential safety and efficacy of B However, actual results could differ from those we currently anticipate.
Thank you if they occur.
It's a pleasure to welcome you to our second quarter accented centric comfortable cost.
Unknown Executive: You are therefore cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this conference call and webcast. Speaking and available for questions today will be Ugur Sahin, Chief Executive Officer; Ozlem Tureci, Chief Medical Officer; and Jean Merritt. Chief Business and Commercial Officer, Zirk Pötting, Chief Financial and Operating Officer, and Ryan Richardson, Chief Strategy Officer. I now hand the call over to Ugur Sahin, BioNTech's CEO. Thank you, Zilke.
The last few months have been a game changing time for brown pick.
The ground breaking potential of our technologies as well so it's really too quickly respond to new challenges and execute Pos.
Has been on full display.
One key highlight is the initiation of the fuel goes straight to be greed car.
Oh, our lead <unk>.
And people on the fixed you to covert 19 vaccine candidate.
We've done a six month stocking the lot speed vaccine discovery, <unk> preclinical and clinical research poker.
In parallel to the Cobot 19 pull gunby have continued to advance the old close you pipeline.
And broaden our base or potential collaboration.
I'm happy about the accomplishments, we estimate in the second quarter and what not paying our entire team and also our partner put their tireless efforts and outstanding commitment.
So that's hard to summarize the sum of all key highlights since our last call to the uptick.
Reached a number of important milestones over the past few months.
We continue to advance our clinical stage pipeline.
And now have so you know topics in clinical testing across three o'clock losses.
That includes eight messenger on its output at pool, gump's pre antibody programs and one small molecule immune modulatory colgan.
In July we and ties a selective BMT running the 60 to be too. It's our lead cobot 19 vaccine candidate and initiated that people are close to to be.
Ugur Sahin: It's a pleasure to welcome you to our second quarter 2020 conference call. The last few months have been a game-changing time for BioNTech. The groundbreaking potential of our technologies, as well as our ability to quickly respond to new challenges and execute fast, has been on full display.
See tile.
We have made progress you know gossiping up our manufacturing capacities to support global supply.
We have fun commercial supply agreement with multiple countries onto book for more than 250 million doses and San Vicente uncertainty 21.
This also includes an option to purchase up to 500 million additional doors.
Ugur Sahin: One key highlight is the initiation of the Pivotal Phase IIb free trial of our lead BNT162 COVID-19 vaccine candidate within six months of starting the Lifespan Vaccine Discovery Preclinical and Clinical Research Program. In parallel to the COVID-19 program, we have continued to advance our oncology pipeline, and broadened our base of strategic collaboration. I'm happy about the accomplishments we have made in the second quarter and would like to thank our entire team and also our partners for their tireless efforts and outstanding commitment.
All this is subject to regulatory approval.
In parallel to our efforts to bring cobot 19 vaccine to the market as quickly as possible.
We also continued to advance our oncology pipeline.
That's really pulled out the key updates later on the call, including four I have pool gum BNP run that 22.
Well go up being too I know that 11 fix segment I know my book.
He'll be announced a new collaboration but for the agenda I want to combine <unk> BNP one of the lapping the Smith tie you and anti PD. One you know randomized phase two trial, which we believe quick has a very good place not a potential.
Ugur Sahin: Slide five summarizes some of our key highlights since our last quarterly update. We have reached a number of important milestones over the past few months, and we continue to advance our clinical stage pipeline. We now have 12 immunotherapies in clinical testing across three drug classes, that includes eight messenger antibody programs, three antibody programs, and one small molecule immune modulatory program. In July, we and Pfizer selected BNT162B2 as our lead COVID-19 vaccine candidate and initiated a pre-voter test to be a free trial. We have made progress in ramping up our manufacturing capacities to support global supply.
Ugur Sahin: We have signed commercial supply agreements with multiple countries around the world for more than 250 million doses in 2020 and 2021. This also includes an option to purchase up to 500 million additional doses. All this is subject to regulatory approval.
Moreover, we significantly from our balance sheet bring in commitments of approximately 1.1 billion in cost policies from non started that due to upfront cash payments.
Equity and debt financing commitments.
These accomplishments have price <unk>, our ability to sponsor <unk> a multiple of problems.
And deliver on our long term ambition to bring novel immuno therapies to patients across a range of diseases.
Moving to slide six.
I would like to touch on the importance of our strategic collaborations.
This is important because these collaborations continue to play a crucial in how we are building or business.
About partnerships extent, hello execution capabilities and global beat.
And in some cases pull out of that access to extend the technologies such as John that's the ore body technology, which are highly complimentary to or.
The first half authentic fenty by expanding our existing partnership this plaza.
Ugur Sahin: In parallel to our effort to bring COVID-19 vaccine to the market as quickly as possible, we also continued to advance our oncology pipeline. Ozlem will provide key updates later in the call, including for our INES program, BNT-122, and our BNT-111 six-segment melanoma program. Here we announce a new collaboration with Regeneron to combine BNT111 with Liptario and enter PD-1 in a randomized phase two trial, which we believe could have registrational potential. Moreover, we significantly strengthen our balance sheet, bringing in commitments of approximately $1.1 billion in gross proceeds from non-dilutive upfront cash payments and equity and debt financing commitments. These accomplishments have strengthened our ability to advance our pipeline on multiple fronts and deliver on our longer-term vision to bring novel immunotherapies to patients across a range of diseases. Moving to slide 6.
John you develop our core with 19 mixing poker.
In addition, do you have stepped became you'll could of course elevation, but so they turned on in the oncology field.
Important aspect here is that he has retained significant economics on our pool gum toward this critical basins.
Sean the pullback on further details on deposit collaboration data you know up prepared remarks.
The case will fill a general India. It is important to note that each party keeps on the put send off device puts all imports.
That means that biotic has kept for product commercialization rights for BMT bundled up 11 million almost exactly.
On slide seven you'll see an updated version of multi platform you know oncology strategy.
The corner Dawn off the strategy is to leverage our immuno toppy expertise this new teleported oppose just to target cancer.
And model it immune because born sooner Tennessee.
I will leave the poets you can put you was most of the.
Pasta product opportunities.
But also the and able to development of powerful combination treatment approaches, which come by Comping until the mechanisms of actions.
Ugur Sahin: I would like to touch on the importance of our strategic collaboration. This is important because these collaborations continue to play a crucial role in how we are building our business, our partnerships, extend our execution capabilities and global reach, and in some cases, provide us with access to external technologies such as GenLabs' dual-body technology, which are highly complementary to our own. In the first half of 2020, we expanded our existing partnership with Pfizer to jointly develop our COVID-19 vaccine program. In addition, we have established a new collaboration with Regeneron in the oncology field. The important aspect here is that we have retained significant economics on our programs through this collaboration. Sean will provide some further details on the Pfizer collaboration later in our prepared remarks. In the case of our general deal, it is important to note that each party keeps 100% of the rights to its own product.
Despite the challenges associated because of course 19 pandemic, we have continued to execute our immuno oncology practice you on multiple points.
We are on track to initiate mouth clear late stage classical six bucks, an honest product candidates.
Anticipating the first data update fall and next generation checkpoint Immunomodulator beyond Q3 hundred 11, a bi specific antibody targeting anti PD, one and pullback in Bebe later this year.
Furthermore, since our last earnings call or do you have initiated a phase fund to probably fall out here that seven I couldn't it's small molecule in human liver three pool gum and expect to initiate first in human cost for two novel that's out there potus in the coming much including 20, Twond that 11 and trust.
<unk> T cell therapy, and fought BMT 220 run a one neoantigen pizza toppings.
As we have done in the POS you've have continued to be data to live in how we assess each product opportunity it takes into clinical testing.
Ugur Sahin: That means that BioNTech has kept full product commercialization rights for BNP111 melanoma 6fac. On slide 7, you see an updated version of our multi-platform immuno-oncology strategy. The cornerstone of this strategy is to leverage our immunotherapy expertise with new therapeutic approaches to target cancer and modulate immune responses simultaneously. We believe this approach can produce multiple blockbuster product opportunities but also will enable the development of powerful combination treatment approaches which combine complementary mechanisms of action.
I will now turn it over to ask them to provide an update on our pool comps.
Thank you.
In the interest of time I'm going to focus my remarks.
Hi.
Nine. These include beyond do you want 11, I watch exact melanoma PNG 122, Oh, I know program Yankee Free 11, our anti PD one inch I for one BP anti body and PNG fly 11, I watch us seven.
So it's not that you can't understate. This all of that programs peace Sweet <unk> quarterly update which will be released <unk>, which was released this morning.
Ugur Sahin: Despite the challenges associated with the COVID-19 pandemic, we have continued to execute our immune oncology strategy on multiple fronts. We are on track to initiate multiple late-stage trials for six-pack and INS product candidates. We are anticipating the first data update for our Next Generation Checkpoint Immunomoderator BNT311, a bispecific antibody targeting N-type PD-L1 and 4-1BB later this year. Furthermore, since our last earnings call, we have initiated a phase 1, 2 trial for our TLR7 agonist small-molecule immune modulatory program and expect to initiate first in human trials for two novel cell therapy approaches in the coming months, including BNT211 and As we have done in the past, we will continue to be data-driven in how we assess each product opportunity we take into clinical testing. I will now turn it over to zlem to provide an update on our program. Thank you, Ugur.
Let's start on slide 10, with Yankee won 11, it along the line will not expect program.
In line yet do you want 11 is composed of flying on mutated melanoma and kitchen and white. The one major eight suite tyrosinase and another enter trends from a lot libraries keep P.T.E. injured I, we published interim phase one data in nature from <unk> ongoing Depomed Merit.
Right.
But it will never try it isn't my two cents open label dose escalation study to evaluate safety and tolerability of fixing need to patients with stage, we'd be C and stage for melanoma.
Because he was evaluated in itself, that's 42 checkpoint inhibitor experienced patients with it they have cut off injured Itwenty 19, as I reported idea. It's a day takes traction date creep patients out of 25 in the expect more Elf European <unk>.
Perion posture with Kolon 70 patients showed stable disease, and one patient show to compete metabolic clinician often that does that depletion.
Ozlem Tureci: In the interest of time, I'm going to focus my remarks on the four programs highlighted on slide 9. These include BNT1.11, our FIXAC melanoma, BNT1.22, our INAS program, BNT3.11, our ENTALPDL1, ENTAL4.1BB antibody, and BNT4.11, our TLR7. For further details on the status of other programs, please refer to our full quarterly update, which will be released this morning So let's start on slide 10 with BNT111, our melanoma FIXAC program. As a reminder, BNT111 is composed of four non-mutated melanoma antigens, NY-Ezo1, MAGE-A3, tyrosinase, and the novel antigen from our own libraries, TPTE.
Well said 17 patients treated with the combination of fix that coffee and do you want.
Anti PD one six patients showed departure was spun.
Oh, no I watch habit dose for the phase two trials of Hundredd, Michael grounds, we all stuff, that's five or 10 patients had to pachauri fun to fix that in combination with anti PD one antibody.
The publication in nature summarized on slide 11 highlighted extensive bio market and immunological data east support the mechanism of action it and the observed clinical activity or fix that alone and in combination with anti PD one impact.
Ozlem Tureci: In July, we published interim phase 1 data in Nature from our ongoing lipomeric trial, a multi-center open-label dose escalation study to evaluate safety and tolerability of vaccinated patients with stage 3bc and stage 4 melanoma. Efficacy was evaluated in a subset of 42 checkpoint inhibitor experience patients with a data cutoff in July 2019. As I reported earlier, at the data extraction date, three patients out of 25 in the FIXAC monotherapy group experienced a partial response. Seven patients showed stable disease, and one patient showed a complete metabolic remission of metastatic lesions.
Ozlem Tureci: Of the 17 patients treated with the combination of FIXAC, BNT111, and an anti-PD-1 antibody, six patients showed a partial response. Of note, at our target dose for the phase 2 trial of 100 micrograms, we observed that 5 of 10 patients had a partial response to FIXVAC in combination with N-type PD-1 therapy. The publication in Nature, summarized on slide 11, highlighted extensive biomarker and immunological data that support the mechanism of action and the observed clinical activity of FIXVAC alone and in combination with N-type PD-1. Importantly, treatment with BNT1-11 resulted in the expansion and activation of circulating tumor antigen-specific T-cells with memory function that exhibited strong cytotoxic activity against tumor cells. Furthermore, these vaccine-induced T-cells displayed a Th1 phenotype. In 20 patients tested by post-IBS interferon gamma ELI spot, all showed an immune response against at least one of the used tumor-associated antigens.
I can see treatment with BMT, one needed Avenue reside in the expansion and activation of circulating tumor antigen specific T cells with memory function that exhibited strong cytotoxic activity against two mindsets he's vaccine induced T cell.
Despite a T.H. one phenotype.
20 patients tested by post I guess, it's tougher on commodities, but also showed immune response against at least one of the used to more associated antigen. Most patients demonstrated <unk> for all concurrent TD four and see the 18th sat with sponsors.
In 50 patients tested by X evil interferon gamma bought which already captured hi magnitude twist sponsor Marvin 75% of patients showed immune responses against at least one too much associated androgen most of which well high magnitude cdeight positive.
He says.
He sets ramped up within four to eight weeks to a single digit or low double digit percentage of total circulating <unk> positive keeps it.
Monthly maintenance treatment.
The other piece that continues to slowly increase all remain table up to over one year.
Safety was assessed in 89 patients.
Overall, I expect treatment was well tolerated with no dose limiting toxicity observed most common sports events, where mild to moderate trends in flu like symptoms such as hiring in show.
As I mentioned earlier, we recently announced a strategic collaboration with Regeneron and plan to puts you wouldn't accelerated development program for the combination of six back end Regenerons anti PD, one agent that tie youre in the second line treatment setting.
For advanced melanoma patients that have progressed after probably a PD one blockade.
No. The trusts offtake agreement, we androgen around have agreed to shed development cost equally it's a pool each party will retain full commercial rights for their respective product and watch record revenues related to its own approach.
Ozlem Tureci: Most patients demonstrated CD4 or concurrent CD4 and CD8 T-cell responses. In 50 patients tested by ex vivo interferon gamma ELI spot, which only captures high-magnitude responses, more than 75% of patients showed immune responses against at least one tumor-associated androgen, most of which were high-magnitude CD8 positive T cells. T-cells ramped up within four to eight weeks to single-digit or low double-digit percentages of total circulating CD8-positive T-cells. Under monthly maintenance treatment, levels of P-cells continued to slowly increase or remain stable up to over one year. Safety was assessed in 89 patients. Overall, six-vec treatment was well-tolerated, with no dose-limiting toxicity observed. The most common adverse events were mild to moderate, transient flu-like symptoms, such as pyrexia in children.
We plan to initiate the randomized phase two trials in the fourth quarter <unk> Twentytwenty and expect to provide more details on the study and that's what quarter Twentytwenty.
Now moving to slide spreads to be Yankee Onetwenty tool a lot individualized neo antigen specific immune if you're a P. I know platform from which is part not with Roche Genentech.
Dave update for the phase one a one off your p. and one be combination with T. centric Boston trials in multiple solid. She wants was reported in June as part of the eight yeah. We're actually enjoyed meeting to business. The first time that we have shown safety and immunogenicity data across different too much.
CAD outside of melanoma.
Patient populations and these cohorts were heavily pretreated menu way for you for factory.
Entry Currentc with a high proportion of no PD, one express or.
Treatment with PNG Onetwenty to Orient in combination with Keith centric was way to tolerate it with the majority of adverse events being grade one all great too and there were no dose limiting toxicities.
Ozlem Tureci: As Ugur mentioned earlier, we recently announced a strategic collaboration with Regeneron and plan to pursue an accelerated development program for the combination of FIXVAC and Regeneron's anti-PD-1 agent, Liptayo, in the second line treatment setting for advanced melanoma patients that have progressed after prior PD-1 blockade. Under the terms of the agreement, we and Regeneron have agreed to share development costs equally If approved, each party will retain full commercial rights for their respective product and would record revenues related to its own product.
And the majority of patients treated with Yankee Onetwenty too low one and in combination with T. centric ex vivo T cell responses against nice if and neo antigens were detected the odds are detected beyond Q1, 22 induced T cells and instead trade off patients to more.
Let's take one aim welfare people portion offered try other 26 patients under went at least once you might assessment, one patient outflows, a with gastric cancer in metastatic devaluation headed Europe.
Ozlem Tureci: We plan to initiate the randomized phase 2 trial in the fourth quarter of 2020 and expect to provide more details on the study in the third quarter of 2020. Now moving to slide 12, our individualized neoantigen-specific immune therapy or INES platform program, which is partnered with Roche Genentech. A data update for the phase 1a immunotherapy and 1b combination with T-centric basket trials in multiple solid tumors was reported in June as part of the AACR virtual annual meeting 2. This is the first time that we have shown safety and immunogenicity data across different tumor types outside of melanoma. The patient populations in these cohorts were heavily pre-treated, many with refractory and recurrent disease, and a high proportion of low PD-L1 expressions. Treatment with BNT-122 alone and in combination with T-centric was well-tolerated, with the majority of adverse events being grade 1 or grade 2. And there were no dose-limiting toxicities.
Each with funds and remains on study after a one day, one and half years and threats patients had stable disease.
In the phase one deep combination portion also TRIR.
In hundreds and a patient that under event at least one to my assessment one patients had to complete response eight patients had partial responses and 53 patients had stable disease.
We continue to believe that I know, it's what she noted earlier line self European across a range of solid tumor.
We have to pick that ongoing phase two trial in first line Milano might go up and excellent clinical trials for I noticed on slide 13.
We expect to provide an enrollment updates from the randomized phase two trial Yankee won 22, plus pembrolizumab in first line melanoma in the second half of Twentytwenty and an interim data updates and to.
Anticipated in the second top of 2021.
We are going to stops.
Two studies and the at children's making.
One.
Yeah, one and then I suppose sensitive can subtype, namely evaluating the efficacy and safety or I know, that's t. centric compared with P. centric alone in patients with birdie, an extra one stage non small cell lung cancer. The second study is and then I.
Ozlem Tureci: In the majority of patients treated with BNT-122-122 alone and in combination with T-centric ex vivo T-cell responses against multiple neoantigens were detected. We also detected BNT-122-induced T-cells in infiltrates of patients' tumors. In the phase 1a immunotherapy portion of the trial, 26 patients underwent at least one tumor assessment. One patient of those with gastric cancer and metastatic liver lesions had a durable, complete response and remained on study after one and a half years, while the rest of the patients had stable disease.
Oh insensitive cans that type, namely a might decide open label phase two randomized trials to compare the efficacy of I noticed whereas the watch sweaters weighting in patients with circulating tumor DNA positive stage, two high risk and stage for you quote on cancer.
Now moving to slide 14 to that to dual body programs, we have Pos not with gen.
Ozlem Tureci: In the phase 1b combination portion of the trial, in 108 patients that underwent at least one tumor assessment, one patient had a complete response, eight patients had partial responses, and 53 patients had stable disease. We continue to believe that INEST is well suited to earlier lines of therapy across a range of solid tumors. We have depicted our ongoing Phase II trial in first-line melanoma and our planned adjuvant clinical trials for INEST on slide 13. We expect to provide an enrollment update from the randomized phase 2 trial of BNT122 plus pembrolizumab and first-line melanoma in the second half of 2020, and an interim data update is anticipated in the second half of 2021. We are going to start two phase two studies in the adjuvant lab. One is in an I.O.
On slide 15, you'll see one offs then beyond Q3 11.
Anti PD, one and type told one he buys specific anti body.
That's a.
Combine constitutive CP I located and can additional cost him the or the Atari activity a mechanism of action, which led to enhance proliferation of antigen specific activated T cells in the presence of PD, one positive says input.
We couldn't it because that.
Based on the preclinical data we have generated we believe this molecule, which we present housewares new <unk>.
<unk> aren't immune modulator with your party potential across a range of solid two most.
We expect to provide the first human data in the second top of Twentytwenty. This update would include dose escalation stage.
Ozlem Tureci: sensitive cancer type, namely evaluating the efficacy and safety of INS plus T-centric compared with T-centric alone in patients with early and adjuvant stage non-small cell lung cancer. The second study is in an I.O. insensitive cancer type, namely a multisite open-label phase 2 randomized trial to compare the efficacy of INS versus watchful weighting in patients with circulating tumor DNA positive, stage 2 high-risk, and stage 3 colon cancer. Now moving to slide 14, to the two dual body programs we have partnered with GENDER. On slide 15, you see one of them, BNT311, the anti-PD-L1, anti-4.1BB bispecific antibody that combines constitutive CPI, locate, and conditional co-stimulatory activity, a mechanism of action that led to enhanced proliferation of antigen-specific activated T cells in the presence of PD-L1 positive cells in preclinical studies. Based on the preclinical data we have generated, we believe this molecule could represent a powerful new checkpoint immune modulator with therapeutic potential across a range of solid tumors.
From the phase one to try it anymore or my chip for solid tumors.
We believe test Roche potentially in a range of solid tumors, including those where checkpoint therapy is currently established but also not just the courage to was west first generation checkpoint inhibitors have not been successfully.
China, you now turning to slide 16, Oh, we recently initiated clinical testing for again, he fought 11 or from our toll like receptor binding program. This molecule is engineered for high potency and has high selectivity fraud.
Our poverty and our seven to reach extra at this year, particularly active dose range. We expect this molecule is a two X T. They both the adaptive and innate immune system in particular in combination with cytotoxic fear views and checkpoint inhibitors three.
Clinical studies suggest a type one interferon dominated release of cytokines and Chemokines and potent denudation off enter true specific <unk> sets, but also be says and innate immune cells, such as NK cells and macrophages.
In early.
July 2020 for first patient was dosed in the Phase 128 first in human open label dose escalation trial with expansion cohorts to evaluate the safety pharmacokinetics pharmacodynamics and preliminary efficacy Yankee for 11 would be passed but as a monotherapy.
Ozlem Tureci: We expect to provide the first human data in the second half of 2020. This update will include dose escalation data from the phase 1, 2 trial in multiple solid tumors. We believe it has broad potential in a range of polytumors, including those where checkpoint therapy is currently established, but also in more difficult tumors where first-generation checkpoint inhibitors have not been as successful. Finally, now turning to slide 16, we recently initiated clinical testing for BNT411 from our toll-like receptor binding program. This molecule is engineered for high potency and has high selectivity for the TLR7 receptor at the theopoietically active dose range.
In patients with solid tumors and in combination with T sand quake cobbled gotten and the top was that in patients with chemotherapy in net east extensive stage small cell lung cancer.
No veith whereby highlights from a lot in college you programs I.
I'd now provides an update on our Cobiz 19 vaccine program.
Now moving to slide 18, which recap how far we have come in but race to develop a cobot 19 vaccine.
We began work on my concern vaccine candidates in late January following use of the current all virus outbreak in China.
Talk some at least six months later, we initiated a pivotal phase to be free trials.
Yeah, that's supporting an approval of a lot vaccine in the U.S. Our goal was five to be in a position to five fu nurturing the authorization from the F.D.A. as early as the fourth quarter of Twentytwenty, if the trial hit our enrollment topic to enroll.
Ozlem Tureci: We expect this molecule to activate both the adaptive and innate immune system, in particular in combination with cytotoxic therapy and checkpoint inhibitors. Preclinical studies suggest a type 1 interferon-dominated release of cytokines and chemokines and potent stimulation of antigen-specific CD8 T-cells but also B-cells and innate immune cells such as NK cells and macrophages. In early July 2020, the first patient was dosed in a phase 1-2a first in human open-label dose escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy. The NT4-11 will be tested as monotherapy in patients with solid tumors and in combination with t-centric carboplatin and adiposites in patients with chemotherapy-nave extensive stage small cell lung cancer.
And on target and is deemed to be successful I.
I would come back to the phase to be fleet try if you sign in a few minutes.
On slide 19, you'll see before vaccine variance, we have taken into clinical testing needs variance vary based on the type of and on a construct used and the engine talk us through also variance targets the RV deep domain and Diablo two before lengths Pike protein.
[noise] most all of the one and B two candidates have received ft, a fast track status.
In late July we along with size that selected CNG onesixty to be tool as well as each candidate for the phase two will be free trials being key onesixty to be tool and quotes for a multi tried worsen afforded by quoting and utilizes on you.
Ozlem Tureci: Now these were the highlights from our oncology programs. I'll now provide an update on our COVID-19 vaccine program. Now moving to slide 18, which recaps how far we have come in the race to develop a COVID-19 vaccine. We began work on multiple vaccine candidates in late January following news of the coronavirus outbreak in China. Approximately six months later, we initiated a pivotal phase 2B free trial aimed at supporting an approval of our vaccine in the U.S. Our goal with Pfizer is to be in a position to file for approval or emergency authorization from the FDA as early as the fourth quarter of 2020. If the trial hits our enrollment target and is deemed to be successful, I will come back to the phase 2B free trial design in a few minutes.
Closed side modified our an eight construct the decision to advise CNG onesixty to be tool was made after an extensive rev. You'll also preclinical then evasive, but syndicated data and incomes are occasion with the SD eight.
For the phase to be free trial, that's hurting me microgram dose level in the two dose regimen was chosen.
Now moving to slide 20.
Yes, you want to 60 tool deep tool vaccinated participants this stage of favor the breadth of at beetle recognized and T cell responses specific to bizarre calls to injection. The candidate also demonstrated concurrent induction of both hi magnitude see he fought and.
The 18th T cell responses.
T cell responses were observed again, bolsa RVP and the remainder also sites like glycol protein, we believe that immune recognition altamont packed. He said if he told me has the potential to generate more consistent with forms that across the world population and.
Ozlem Tureci: On slide 19, you see the four vaccine variants we have taken into clinical testing. These variants vary based on the type of mRNA construct used and the antigen target. Two of the variants target the RBD domain, and the other two target the full-length spike protein. Both our B1 and B2 candidates have received FDA fast-track approval. In late July, we, along with Pfizer, selected BNT162b2 as our lead candidate for the phase 2b3 trial. BNT162b2 encodes for a modified version of the full spike protein and utilizes our nucleoside-modified RNA concept. The decision to advance BNT162b2 was made after an extensive review of the preclinical and available clinical data and in consultation with the FDA. For the phase 2b free trial, the 13 microgram dose level in a two-dose regimen was chosen. Now, moving to slide 20.
Okay.
Preliminary data flow of Yankee won 62 will be pool suggest that it's favorable reactogenicity pool, five systemic events were generating mild to moderate and trends and staffing wanted to date events included fever, such unique and ships they have not been any serious.
I see events observed in our again he won 62 program.
They pet CT action from the phase one trials for AWS four vaccine candidates. It's continuing we plan to some data on again you on 60 to be tool for a period, you'll and potential publication in the next few weeks. We also intend to also post the men's scripts.
On the pre print server at that time.
Moving to slide 21, I'd like to spend a few minutes to outline. The design also ongoing phase to be free trial. The study is expected to enroll up to 30000 participants aged 18 to 85 years, starting in the U.S. and expanding to include approximately.
Ozlem Tureci: BNT162b2 vaccinated participants displayed a favorable breadth of epitopes recognized in T-cell responses specific to VASAR-CoV-2 antigen. The candidate also demonstrated concurrent induction of both high-magnitude CD4 and CD8 T-cell responses. These T-cell responses were observed against both the RBD and the remainder of the spike glycoprotein.
<unk> hundred 70 sites globally. Good try regions will include areas with significant anticipated so close to transmission, but safe to be free trial is a one to one vaccine candidates.
Well randomized observer blinded study to obtain the safety immune response into secrecy data needed for regulatory risk.
The primary unclaimed Preventional school with 19 and puts us at SUNS without evidence of Sop close to inspection before vaccination.
Ozlem Tureci: We believe that immune recognition of more spike T-cell epitopes may have the potential to generate more consistent responses across diverse populations and in older adults. However, preliminary data for BNT162b2 suggested a favorable reactogenicity profile. Systemic events were generally mild to moderate and transient, lasting one to two days. They included fever, fatigue, and chills. There have not been any serious adverse events observed in our BNT162 program. Data collection from the phase 1-2 trial for all four vaccine candidates is ongoing. We plan to submit data on BNT162b2 for peer review and potential publication in the next few weeks. We also intend to post the manuscript on the preprint server at that time. Moving to slide 21, I'd like to spend a few minutes outlining the design of the ongoing Phase 2b free trial. The study is expected to enroll up to 30,000 participants aged 18 to 85 years, starting in the U.S. and expanding to include approximately 120 sites globally. The trial regions will include areas with significant anticipated SARS-CoV-2 transmission.
Preventional covert 19, and put this system regardless of cycles to inspection before nation. The primarily if I can see another this would be an event driven analysis based on the non golf discipline symptomatic covert 19 disease, where they use polymerase chain react.
One quick one song infection or south coast to Suncoke energy test.
So previous exposure.
One of the secondary endpoints include prevention or severe cold with 19 disease.
The trial design allows for interim analysis and underlying to drive used by an independent external data monitoring committee.
Assuming clinical success, we along with Pfizer may potentially see Greg <unk> regulatory revenue in Q4 as early as October trend he 20.
With that I would now hand over to song to provide an overview on our commercial uptake.
Ozlem Tureci: The Phase 2b free trial is a one-to-one vaccine candidate to placebo-randomized observer-blinded study to obtain the safety, immune response, and efficacy data needed for regulatory review. The primary endpoint is prevention of COVID-19 in participants without evidence of SARS-CoV-2 infection before vaccination, as well as prevention of COVID-19 in participants regardless of SARS-CoV-2 infection before vaccination. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. We will use polymerase chain reaction to confirm infection with SARS-CoV-2 and antibody tests to confirm previous exposure.
Thank you cool I.
I will start by recapping, all commercial arrangements with B and C. One since two with Pfizer and close.
Depicted on slide 22.
Our collaboration Besides you involves co development portfolios codes that 19 vaccine candidates from a worldwide basis, excluding China.
Upon approval, we will jointly commercialize the vaccine with Pfizer.
Part of our preparation for commercialization.
Hey on Tech is basically taking steps to establish a limited commercial infrastructure in the select to several countries, while leveraging pfizer's commercial infrastructure and capabilities in the rest of the world Excluding Charnaux. So just Medicaid.
In terms of financials, our collaboration with Pfizer is based on a 50 50 partnership.
Hi, somebody shale development expenses in gross profits worldwide on a 50 50 basis, [noise], regardless of which can be distributes the vaccine in a good from country.
But at the mall capital expenditures of funded by each policy independently.
In addition to the combined upfront payments in equity investment of 195 million.
Yes dollars, which the onto it received in April.
Ozlem Tureci: One of the secondary endpoints includes prevention of severe COVID-19 disease. The trial design allows for interim analysis and unblinded reviews by an independent external data monitoring committee. Assuming clinical success, we, along with Pfizer, may potentially seek regulatory review in Q4 as early as October 2020. With that, I will now hand over to Sean to provide an overview of our commercial. Thank you, Ugur.
In fact is eligible to receive further development, so small sense of up to 563 million U.S. dollars.
If reached these my sense would come in addition to be on takes 50% share.
Gross profit is generally weak.
Our first in collaboration in China. It's also Crazy thing for me to treatment.
However, facing from some the geology of development expenses incurred in China.
But take on commercialization.
He says the vaccine is approved.
In addition to the combined upfront payment of the equity investment totaling 51 million U.S. dollars, which was a perceived in April.
Ryan Richardson: I will start by recapping our commercial arrangements for BNT162 with Pfizer and Closin, depicted on slide 22. Our collaboration with Pfizer involves co-development of a portfolio of COVID-19 vaccine candidates on a worldwide basis, excluding China. Upon approval, we would jointly commercialize the vaccine. As part of our preparation for commercialization, BioNTech is taking steps to establish a limited commercial infrastructure in a selected set of countries, while leveraging Pfizer's commercial infrastructure and capabilities in the rest of the world, excluding China, as I've just noted. In terms of finances, our collaboration with Pfizer is based on a 50-50 partnership. Both companies share development expenses and gross profits worldwide on a 50-50 basis, regardless of which company distributes the vaccine in a given country. Furthermore, capital expenditures are funded by each party independently.
They own check is eligible to receive tragedy parliament. So small stage dropped to eight useful mid U.S. donors they onto but also share gross profits on the sale of the vaccine in China.
I'll now turn to slide 23 to provide an overview of our recently announced commercial supply agreements.
From the beginning we're being very clear about our intention to make all vaccines available for Greg will supply to address the plant them. It.
We are investing at risk to scale up our manufacturing to enable us to do.
They don't take from Pfizer I have a target to manufacture up to 100 million doses by the end to two Kashi interim tree and approximately 1.3 billion doses from the end of 2022 well.
This estimate assumes a continued ramp up introduction I'll eat up overtime.
And Mike facilities in Germany, which are currently producing vaccine for clinical supply.
Ryan Richardson: In addition to the combined upfront payment and equity investment of $185 million U.S. dollars, which BioNTech received in April, BioNTech is eligible to receive further development and sales milestones of up to $563 million U.S. dollars. If reached, these milestones will come in addition to BioNTech's 50% share of gross profits generated. Our Fosun collaboration in China is also a co-development agreement.
Well said, where can you size it to activate and then pop back and production of several Pfizer side can you not you stage and one in Europe.
Well it you're still Daddy, we have announced commercial supply agreements with the government should multiple countries, who multi 250 million doses.
With an option for an additional 500 million doses.
Furthermore, weights on being a number of discussions with governments around the world in relation to further commercial supply.
Ryan Richardson: However, Fosun funds the majority of development expenses incurred in China and would take on commercialization responsibilities if the vaccine is approved. In addition to the combined upfront payment and the equity investment totaling US$51 million, which was received in April, BioNTech is eligible to receive further development and sales milestones up to US$84 million. BioNTech would also share gross profits on the sale of the vaccine in China. I will now turn to slide 23 to provide an overview of our recently announced commercial supply agreement. From the beginning, we have been very clear about our intention to make our vaccines available for global supply to address the pandemic, and we are investing at risk to scale up our manufacturing to enable us to do so.
All agreements are subject to clinical success and rectal cream, so looking back to me.
I will now handover to sell to.
To provide them updates from our financials.
Thank you Sean.
Now I would like to summarize our financial results for the quarter that are shown on slide 25.
Or total revenue, which primarily consist of revenue from all collaboration agreements.
41.8 million euros for the second quarter, Twentytwenty compared to 25.8 million Joe's for the second quarter 2019.
For the period off six month ended June Thirtyth, Twentytwenty or total revenue was 69.4 million euros compared to 51.9 million euros for the compared to prior year period.
The revenue from collaboration agreements overall increased due to the recognition of revenue from our new collaboration agreement signed with Pfizer and Fosun pharma.
Ryan Richardson: BioNTech and Pfizer have a target to manufacture up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021. This estimate assumes a continued ramp-up in production at our Ida-Oberstein and Mainz facilities in Germany, which are currently producing vaccines for clinical supply. We're also working with Pfizer to activate and ramp up vaccine production at several Pfizer sites in the United States and one in Europe. While it is still early, we have announced commercial supply agreements with the governments of multiple countries for more than 250 million doses, with an option for an additional 500 million doses. Furthermore, we are currently in a number of discussions with governments around the world in relation to further commercial supply, but all agreements are subject to clinical success and regulatory approval of the vaccine. I will now hand over to Seat to provide an update on our finances. Thank you, Sean.
The order BNP Onesix to vaccine program against Cobiz 90.
The revenues other states transactions increased due to increased orders and you could say it's off diagnostic product.
Pipe ritual viral vectors for kids, a good supply development manufacturing services sold to third party customers.
Research and development expenses were 95.2 million euros for the second quarter 2020, compared to 53.4 million euros for the second quarter 2000 bumpy.
For the six month ended June 32020, totally research and development expenses were 160.3 million euros compared to 110.6 million euros for the comparative prior year period.
The increase was mainly due to an increase going to headcount leading to higher wages benefits and social security expenses.
Well, if an increase in expenses for purchase research and development services.
Especially with respect to or being 206 two program.
In addition from the date of acquisition or New U.S. based subsidiary I don't think U.S. stink contributed 5.3 million euros to our research and development expenses.
Unknown Executive: Now I would like to summarize our financial results for the quarter, which are shown on slide 25. Our total revenue, which primarily consists of revenue from our collaboration agreements, was €41.8 million for the second quarter of 2020 compared to €25.8 million for the second quarter of 2019. For the period of six months ended June 30, 2020, our total revenue was €69.4 million, compared to €51.9 million for the comparable prior year period. The revenue from collaboration agreements overall increased due to the recognition of revenue from our new collaboration agreement signed with Pfizer and Fosun Pharma as part of our BNT162 vaccine program against COVID-19. The revenues from other sales transactions increased due to increased orders and include sales of diagnostic products, peptides, retroviral vectors for clinical supply and development, and manufacturing services sold to third-party customers.
Unknown Executive: Research and development expenses were €95.2 million for the second quarter of 2020, compared to €53.4 million for the second quarter of 2019. For the six-month end of June 30, 2020, total research and development expenses were €160.3 million, compared to €110.6 million for the comparative prior year period. The increase was mainly due to an increase in headcount, leading to higher wages, benefits, and social security expenses, as well as an increase in expenses for purchased research and development services, especially with respect to our BNT 162 program. In addition, from the date of acquisition, our new U.S.-based subsidiary, BioNTech U.S. Inc., contributed 5.3 million euros to our research and development expenses. General and administrative expenses were 18.8 million euros for the second quarter of 2020 compared to 14.6 million euros for the second quarter of 2019. For the sixth month ended June 30, 2020, total general and administrative expenses were 34.6 million euros compared to 23.9 million euros for the comparative prior year period. This increase was mainly influenced by higher expenses for purchase management consulting and legal services as well as an increase in head count leading to higher wages, benefits, and social security expenses.
General and administrative expenses were 18.8 million euros for the second quarter twin 20, compared to 14.6 billion euros for the second quarter 2019.
Unknown Executive: In addition, from the date of acquisition, our new U.S.-based subsidiary BioNTech U.S. Inc. contributed 1.6 million euros to our general and administrative expenses. Net loss was 88.3 million euros for the second quarter of 2020 compared to 50.1 million euros for the second quarter of 2019. For the six-month end of June 30, 2020, total net loss was €141.7 million, compared to €90.8 million for the comparative prior year
Well the six month ended June 30, Twentytwenty total general and administrative expenses were 34.6 billion euros compared to 23.9 million euros for the comparative prior year period.
This increase was mainly influenced by higher expenses for purchase management consulting and legal surfaces as well as an increase in headcount didnt try wages benefits in pushing security expenses.
In addition from the data acquisition, our new U.S. based subsidiary by on Pik, USA Inc. contributed 1.6 billion euros to or general and administrative expenses net loss was 88.3 million euros for the second quarter 2020, compared to 50.1 billion euros for the second quarter 2019.
For the six month ended June 32020, total net loss was 141.7 billion euros compared to 90.8 million euros for the comparative probably your period.
Turning to the balance sheet on slide 26, biotech ended the second quarter 2020 with cash cash equivalents.
Current 73 million euros was $641.6 billion.
Additionally.
We raised 680.7 billion euros or $762.2 billion in gross proceeds from a private equity placement and or follow on underwritten offering after the until the second quarter.
Considering these gross proceeds expected pro forma cash cash equivalent balance at June 30, 2020 amounts to 1.25 billion euros or $1.4 billion further we announced the debt financing of up to 100 million euros or $112 million.
From the European investment Bank in June 2020.
All financing transactions are subject to closing conditions. They were not for food before June 30, 2020, and did not have an accounting impact within the second quarter 2020.
As a result increased spending related to BNP onesix too. We now expect net cash used in operating activities for purchases of property and equipment to be between 450 million euros, and 600 million euros for the full year Twentytwenty.
We anticipate that existing cash and cash equivalent the net proceeds from the recent underwritten offering and the expected net proceeds from the private investment announced in June 2020 will enable us to fund our operating expenses in capital requirements through <unk>.
At least the next 24 month.
With that I will return the call back too high for concluding remarks, Thank you Sir.
Slide 20, southern outlines the key milestones were focused on delivering as we look to the remainder of 2020.
Unknown Executive: Turning to the balance sheet on slide 26, BioNTech ended the second quarter of 2020 with cash and cash equivalents of €573 million or $641.6 million. Additionally, we raised 680.7 million euros or 762.2 million dollars in gross proceeds from a private equity placement and our follow-on underwritten offering after the end of the second quarter. Considering these gross proceeds, the expected pro forma cash and cash equivalence balance at June 30, 2020 amounts to 1.25 billion euros or 1.4 billion dollars. In addition, we announced a debt financing of up to 100 million euros or 112 million dollars from the European Investment Bank in June 2020. All financing transactions are subject to closing conditions that were not fulfilled before June 30, 2020 and did not have an accounting impact in the second quarter of 2020.
The first relates to work over 19 vaccine program, where the next major milestone as the phase to be three trial were conducting Pfizer.
As often mentioned, we expect to be in a position to seek regulatory review as early as October 20 Twond.
In the meantime, we expect to publish phase one safety and Immunogenicity data for be into one six to be true in the next few weeks.
We also intend to published preclinical data over the same time period.
In addition, we anticipate three first in human data updates for oncology programs over the course of a year.
Including for BMT, one one for the into 131.
And our dual body program.
The M.T. three one more.
Data from our Binchy, one one for six phase one study in triple negative breast cancer has been accepted corn oil presentation that small and mid September.
The phase one study is a three arm trial as a monotherapy and in combination with honest evaluating safety and Immunogenicity.
But it would be presenter will include a preliminary analysis of immune responses and TNBC patients treated honest.
Unknown Executive: As a result of increased spending related to BNT162, we now expect net cash used in operating activities and for purchases of property and equipment to be between 450 million euros and 600 million euros for the full year 2020. We anticipate that existing cash and cash equivalents, the net proceeds from the recent underwritten offering, and the expected net proceeds from the private investment announced in June 2020 will enable us to fund our operating expenses and capital requirements for at least the next 24 months. With that, I will return the call to Ryan for his concluding remarks. Slide 27 outlines the key milestones we're focused on delivering as we look to the remainder of 2020. The first relates to our COVID-19 vaccine program, where the next major milestone is the Phase 2B3 trial we are conducting with Pfizer. As Ozlem mentioned, we expect to be in a position to seek regulatory approval as early as October 2020.
For Brinci 131, part Tomorrow night intra Tumoral immunotherapy program partner with Sanofi, We expect the data update for our phase one two trials in solid tumors in the second half of 2020.
The study as a first in human Multicenter open label Phase one dose escalation an extension trial to evaluate safety pharmacokinetics, pharmacodynamics and anti tumor activity.
Of the into 131, both as a monotherapy and combination with some diplomat in patients with certain advanced solid tumors, but.
The data to be presented will include safety Tolerability and Pharmacodynamic biomarker data.
Well updates for these programs will focus on safety and Immunogenicity, we expect that our preliminary update for be into 311 or by specific antibodies will also include topline response data from our ongoing phase one two trial.
And finally, we plan to initiate up to six additional studies from oncology pipeline over the remainder of 2020.
Include randomized phase two trials for six back in melanoma in HPV 16 positive had met cancers.
Ryan Richardson: In the meantime, we expect to publish phase one safety and immunogenicity data for BNT162b2 in the next few weeks. We also intend to publish preclinical data during the same time period. In addition, we anticipate three first-in-human data updates for our oncology programs over the course of the year, including for BNT114, BNT131, and our dual body program, BNT 311. Data from our BNT114 FIXVAC Phase 1 study in triple negative breast cancer have been accepted for an oral presentation at ESMO in mid-September. The Phase I study is a three-arm trial as monotherapy and in combination with INEST evaluating safety and immunogenicity. The data to be presented will include a preliminary analysis of immune responses in PNBC patients treated with INAH. For BNT131, our mRNA intratumoral immunotherapy program partnered with Sanofi, we expect data for our Phase 1-2 trial in solid tumors in the second half of 2020. The study is a first-in-human, multi-center, open-label, phase-one dose escalation and expansion trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of BNT131 both as monotherapy and in combination with siniplomab in patients with certain advanced solid tumors.
I noticed an argument NSCLC argument CRC cancers.
We also anticipate initiating first in human trials for our cell therapy programs, starting with our quota and six car T cell therapy.
First program to incorporate our car T amplifying marni about sheet or korba approach.
And with that I'll hand, it back over to Hoover concluding remarks.
Thank you Juan.
Part of what the half accomplish over the first half of tend to 70 and belief at commended simple Kona T. last before.
The rethink our show who doesn't partners for their trust and support.
That does open up the cost for Crescent snow.
Thank you ladies and gentlemen, we rely begin the question answer session. As a reminder, if you do wish to ask a question. Please press star one on your telephone.
What's your name to be taken by an operator.
If you wish to come see Everquest. Please press the Hush Kay.
Once again, if you wish to ask a question. Please press star one on your telephone.
Somebody while we compile the cumin eight kids this will take a few moments.
Your first question comes from the line of Caffeine Ahmed from Bank of America piece. That's your question.
Ryan Richardson: The data to be presented will include safety, tolerability, and pharmacodynamic biomarker data. While updates for these programs will focus on safety and immunogenicity, we expect that our preliminary update for BNT 3.1.1, our bispecific antibody, will also include top-line response data from our ongoing Phase 1.2 trial. And finally, we plan to initiate up to six additional studies from our oncology pipeline over the remainder of 2020. These include randomized phase two trials for FIXVAC and melanoma and HPV16 positive head and neck cancers, and for INEST and adjuvant NSCLC and adjuvant CRC cancers.
Hi, Good morning. This is bill mono for disease. So two from me.
First of all.
How do you think about distributing the initial dose is ever going to be manufactured.
Later, this year of the vaccine or the potential for vaccine assuming approval.
So the initial doses manufactured later this year in early next year.
Given that.
First manufacturing batches world.
The recover all or supply agreements and then secondly.
Ryan Richardson: We also anticipate initiating first-in-human trials for our cell therapy programs, starting with our Claudin-6 CAR-T cell therapy, the first program to incorporate our CAR-T amplifying mRNA vaccine, or CARVAC, approach. And with that, I'll hand it back over to Ugur for concluding remarks. Thank you, Ryan.
When you have to.
We pay the Pfizer upfront investment.
Out of.
Gross profit sharing can you help quantify what Pfizer is already put up in terms of upfront investment and what the pace of of.
Ugur Sahin: I'm proud of what we have accomplished over the first half of 2020 and believe a tremendous opportunity lies before us. We thank our shareholders and partners for their trust and support. Let us open the call to questions now. Thank you.
Paying that back would be out of.
Profit share and milestones.
Yeah. So I'll start with the first question. This is Ryan on the distribution side, and then turn it over to Sherk are coming on the second [noise].
So I think we're in the one fortunate position to have a.
Unknown Executive: Ladies and gentlemen, we will now begin the question and answer session. As a reminder, if you do wish to ask a question, please press star 1 on your telephone and wait for your name to be taken by an operator. If you wish to cancel your request, please press the hash key.
Considerable demand or interest in the vaccine as you can see who know support deals that we've announced so far some of those deals you call for just to be supported 2020, others in 2021.
Indicated that by 2000 into 2020, we expect to have up to 100 million doses and then expect to be able to increase our capacity pretty significantly as we head into 2021. So I think we can't get into specifics at this point, but I think safe to say that we will already with the distribution agreements that we've announced we feel confident that the doses that we can produce will be.
Unknown Executive: Once again, if you wish to ask a question, please press star 1 on your telephone. Please stand by while we compile the Q&A queue. This will take a few moments.
Well to distribute across the countries that are included in those agreements.
William Patrick Maughan: Your first question comes from the line of Tazeen Ahmad from Bank of America. Please ask your question. Hi, good morning. This is Bill Maughan on behalf of Tazeen.
I don't know sort you want to comment on the second question.
Ryan Richardson: So two from me. First of all, how do you think about distributing the initial doses that are going to be manufactured later this year of the vaccine, the potential COVID vaccine, assuming approval? So the initial doses manufactured later this year and early next year, given that the first manufacturing batches won't immediately cover all supply agreements. And then, secondly, when you have to repay the Pfizer upfront investment out of profit sharing, can you help quantify what Pfizer has already put up in terms of upfront investment and what the pace of paying that back would be out of profit share and milestones? Thank you.
Oh, yes happy to that actually so in Q2. This this was the first reconciliation that we just with with Pfizer and.
This quarter, we reconciled.
50 million as the total net net cost on the buy on that side actually this what the 50% of course share probably on the this quarter, so compared with the told a program.
So small amount because it was ramping up in April and May and June so far.
Okay do you mean was recognized as.
As a cost so far that's our share.
Okay, and I guess, how do you get to that 20 million given.
The large numbers of Pfizer as kind of put out in terms of.
What they're investing in their manufacturing.
Yes, so there's only a certain type of cross section there not everything is shaped 50 50, so investments are.
Unknown Executive: Yes, I'll start with the first question, which is Ryan on the distribution side, and then turn it over to Cirque to comment on the second. So I think we're in the fortunate position to have considerable demand or interest for the vaccine, as you can see from the supply deals that we've announced so far. Some of those deals call for doses to be supplied in 2020, others in 2021. We've indicated that by the end of 2020, we expect to have up to 100 million doses and then expect to be able to increase our capacity pretty significantly as we head into 2021. So I think we can't get into specifics at this point, but I think it's safe to say that with the distribution agreements that we've announced, we feel confident that the doses that we can produce will be able to be distributed across the countries that are included I don't know, sir; do you want to comment on the second question? Yes, I'd be happy to.
Investments into capacity is everybody's on cost and what share. They usually these development cost him at scale up. So this this is share it and this is the 20% 20 million is our.
Our part of this year and so far it's covered from our upfront that we received when signing the contract.
Okay. Thank you.
Sure.
And your next question comes from the line of Kuwait Caseloads from JP Morgan piece. That's your question.
Hey, guys. Thanks for taking my question. This is Matthew on for Corey I'm, Sorry, I was just wondering for Banshee Onesix too. If you can talk a little bit about how you maintained the integrity of a phase three blinded trial when a large proportion of being tier 162 patients are expected to get fevers another systemic age.
Unknown Executive: Yeah, actually, so in Q2, this was the first reconciliation that we did with Pfizer. And this quarter, we reconciled 20 million as the total net cost on the BioNTech side. Actually, this was 50% of the cost share for BioNTech in this quarter. So compared to the total program, still a small amount because it was ramping up in April, May, and June so far. So $20 billion was recognized as... as cost so far as our share. Okay, and I guess how do you get to that 20 million given, you know, the large numbers that Pfizer has kind of put out in terms of what they're investing in their manufacturing? Yeah, so there's only a certain type of cost share. So not everything is shared 50-50. So investments are, investments into capacity are everybody's own cost, and what's shared is basically the development cost and scale up. So this is shared, and this 20 million is our share of the investment.
And what your views on whether those could impact the ultimate how clinical trial.
Yeah. So so thanks for the Crescent vessel or.
First of all as the as they indicated in the press release.
And then we announced the selection of B and C 160 to be too.
As a.
Okay that that abbvie to them.
Significantly better, Florida, they tend to be one yeah.
Actually actually only Elizabeth section of vaccinated individuals.
FEIBA.
And as we got to the to the other symptoms.
You might have seen that even pet siebel.
Vaccinated subjects have a number that cone that concept and so we believe that that we have a very good overall situation and add to avoid any type of biased negotiated by but understanding by the understanding of the participant that he might or Shimon.
Unknown Executive: And so far, it's covered from our upfront payment that we received when signing the contract. Okay, thank you. Sure.
And well get the vaccine and not the cap table.
Okay, Great and then just wondering if you can walk us through your assumptions are essentially what needs to happen for the phase three program to get data and potential regulatory filing in October I'm, just I guess, maybe if you can you help quantify how dependent focuses on.
Matthew: And your next question comes from the line of Corey Kazimoff from J.P. Morgan. Please ask your question. Hey guys, thanks for taking my question. This is Matthew on behalf of Corey.
Ozlem Tureci: So I guess I'm just wondering for BNT162, if you can talk a little bit about how you maintain the integrity of a phase three blinded trial when a large proportion of BNT162 patients are expected to get fevers and other systemic adverse events, and what your view is on whether this could impact the ultimate outcome of the trial. Thanks for the question. First of all, as we indicated in the press release when we announced the selection of BNT162B2, we indicated that B2 is significantly better tolerated than B1. So actually, only a small fraction of vaccinated individuals have fever. And with regard to the other symptoms, you might have seen that even placebo-vaccinated subjects have a number of background symptoms. So we believe that we have a very good overall situation to avoid any type of bias mediated by the participant's understanding that he might or she might get the vaccine and not the placebo. Okay, great.
Either enrollment on infection rates or what might be the the key factor you.
In the top.
Yeah.
So [laughter] so soda, though this is this is this is as you can see time. This means that means offensive today, we are comparing the number.
Insects that.
Infections in the placebo thus in the treatment group.
We are on nine evaluated in a blind upset blended session them the safety data.
Yeah. The tide is this proceeding very though it's even more coating process and then than anticipated.
And then go over all concept is is too and to elevate the until you have a given precise number but even that of is that infections, even and then and then your do.
So evaluation, if there's significant significant difference between vaccine or placebo groups.
And the number the number that you Ben number so we will have several.
So oh option yeah.
Earlier this month, even numbers, yeah, and based on that based on the lower even nimbus you might be able to spy or that you know October yeah.
It said that they know what you've done some but do not support a filing and I'll be the left opportunity to tools to five to size for six weeks later based of costs on the assumption that the try this positive.
Ugur Sahin: And then just wondering if you can walk us through your assumptions or essentially what needs to happen for the phase three program to get data and a potential regulatory filing in October. And just, I guess, maybe if you can help quantify how dependent this is on either enrollment or infection rates or what might be the key factor and in the timeline. Yeah, so this is an efficacy trial. That means, at the end of the day, we are comparing the number of infections in the placebo group versus the treatment group. We are online evaluating safety data in a blinded session. The trial is proceeding very well. It's even recruiting faster than anticipated, and the overall concept is to wait until we have a given predefined number of events, of infection events, and then do a first evaluation if there's a significant difference between the vaccine and the placebo group.
Great. Thanks for taking my questions.
Okay.
[music].
Your next question comes from the line of Arlinda Lee from kind of core piece. That's your question.
Congrats on all the progress I.
Ugur Sahin: And the number, the event number, so we will have several, several options to evaluate different event numbers. And based on that, based on the lower event numbers, you might be able to file already in October. If the lower event numbers do not support a filing, we will have the opportunity to file four or six weeks later based, of course, on the assumption that the trial is positive. Great, thanks for taking my questions. Yeah, I'll go back.
Well she's on once it's true one can you provide an update on the enrollment of the pivotal trial into <unk>.
Yes, I heard that some of the net cost.
Trials.
Uh huh.
Good.
Sure.
The development.
Arlinda Lee: Your next question comes from Arlinda Lee from Canaccord. Please ask your question. Thank you, guys. Congratulations on all the progress. I had a couple questions on 1.5.2. One, can you provide an update on the enrollment in the pivotal trial? And two, I heard that some of the net costs for the trials have already been, We've given guidance that that was earlier.