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`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 1 of 5 PagelD #: 12600
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`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 2 of 5 PageID #: 12601
`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 2 of 5 PagelD #: 12601
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`REFINITIV STREETEVENTS
`EDITED TRANSCRIPT
`MRNA.OQ - Moderna Inc Corporate Analyst Meeting
`
`EVENT DATE/TIME: SEPTEMBER 17, 2020 / 12:00PM GMT
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`REFINITIV [~
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`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 3 of 5 PageID #: 12602
`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 3 of 5 PagelD #: 12602
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`SEPTEMBER 17, 2020 / 12:00PM, MRNA.OQ - Moderna Inc Corporate Analyst Meeting
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`That review by FDAis also an independentregulatory review, and they themselvesalso seek independentadvice from a committee called VRBPAC
`or the Vaccines and Related Biological Products Advisory Committee. So the point | would like to underscoreis that throughoutthis process, there
`are independentreviewsof data, both in an ongoing way and oncethe analyses have been concluded. And that independentreview really gives
`confidence that the data generatedin this trial are representative and can be relied upon to give confidence to implementation of a vaccine
`program.
`
`So let's moveto the next slide, where I'm going to speak a little bit more about the DSMB monitoring of the primary efficacy endpointin a bit more
`detail. And I'm going to take a couple of minutes with this slide becauseit is a bit complicated. I'd like to start the graph on theright.
`
`So whatthe graph onthe right showsyouis the cumulative boundary crossing probability on the y axis as a function of vaccine efficacy on the x
`axis. In any efficacy trial, the likelihood of meeting your endpointsis really based on 3 factors: the overall efficacy of the vaccine; secondly, the
`samplesize, so larger sample sizes lead to closer refinements of point estimates to the actual efficacy; and then third, the random distribution of
`events as you go through a trial. So in any giventrial, you don't necessarily receive cases that occur in the vaccine group andcontrol group in an
`alternating fashion. They comeinto thetrial and are reported randomly.
`
`So how doesthis graph help us understand howlikely we are at various interim analyses to meetthestatistical criteria? Well, if we move to the
`next slide, what wesee is a vaccineefficacy highlighted in blue at 60%. Andthis is important because 60% is the conservative assumption that we
`used when wedesignedthetrial. Obviously, we are quite hopeful that the true vaccine efficacy will be higher. And what you see on the left-hand
`side of the grid is that thefirst efficacy interim analysis will be performed when 53 cases are accumulated. That's shownin the fine dotted line
`labeled interim analysis 1 on the graph. At interim analysis 1, if the vaccine efficacy is 60%, there's a 10% probability that we are able to meet the
`statistical criteria successfully.
`
`But as we capture morecases, on the next slide, so now we're talking about the secondinterim analysis, where there are 106 cases accumulated,
`you see that with the higher samplesize, the likelihood of meeting our statistical criteria increases to 65%. And bythe time wereachthefinal
`analysis on Slide 136, at 151 cases accumulated, we have a 90% probability of successfully meeting that statistical criterion. And that's really what
`we're speaking about whenwerefer to a study having 90% power.
`
`So the study wasreally designed to look at 151 cases, but because webelieve that our vaccine may be moreefficacious than 60%, we've designed
`theseinterim analysis to allow ourselves the opportunity to investigate the data and potentially concludethetrial earlier based on meeting those
`criteria.
`
`So if we go to the next slide, now we're going to go through the same3 different analyses, but see what happens when weland at 75% efficacy.
`So if we moveto Slide 138, what you can seeis with just a 15% increasein efficacy, at the first interim analysis, there's now a 50% probability of
`successfully meeting our statistical criteria.
`
`Onthe next slide, 139, you see that once you get to then the second interim analysis or 106 cases of COVID-19 accumulated, the likelihood of
`meetingstatistical criteria exceeds 95%. So | hope that that helps demystify a bit how wewill be monitoring the safety and the efficacy of our data
`while we go through the study. And wereally look forward to bringing you more updatesof these data as they occur.
`
`I'll conclude my presentation, and I'm going to hand over to mycolleague, Juan Andres, who will speak to you about the manufacturing and
`distribution of the COVID-19 vaccine.
`
`Juan Andres - Moderna, Inc. - Chief Technical Operations & Quality Officer
`
`Thank you,Jackie. Good morning, good afternoon or good evening. My nameis Juan Andres, and | have responsibility for clinical development,
`manufacturing and quality in Moderna.
`
`Slide 141, please. As we discussed in previous meetings, weare a platform, which in manufacturing terms mean thatall our products are madein
`a very similar way.This allows that any learning and improvements that we have had overthe years can be applied acrossour pipeline.
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`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 4 of 5 PageID #: 12603
`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 4 of 5 PagelD #: 12603
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`SEPTEMBER 17, 2020 / 12:00PM, MRNA.OQ - Moderna Inc Corporate Analyst Meeting
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`Next slide. Because we know the importance of improving our platform, it has been a top companypriority to invest in CM and C, chemistry,
`manufacturing and controls. The fundamental product understanding has allowed us to make tremendousprogressin shelflife, storage temperature,
`safety andtolerability, potency and consistency of manufacture.
`
`Next slide. Specifically, mRNA-1273, our COVID vaccine candidate, benefits from the progress we have made withall the other vaccines in the
`pipeline. On the left-hand side, you can see 3 different graphs. Each graph representsa critical quality attribute for the product. Each dotin its
`graphrepresents a real GMP batch manufactured during the developmentof 1273. The values show very high consistency, and you would not be
`able to differentiate that there are 3 different scales in each graph, small, medium andlarge.Thislevel of consistency is what you wantto see during
`the scale-up of a product.
`
`Next, please. We presented extensively in March our manufacturing site in Massachusetts. We wantedit fully integrated, end-to-end, to ensure we
`masteredall parts of our process. In addition, we designed a plan with a high degree of automation and digital integration to allow rapid growth
`andscale.Little we knew then that this thinking was goingto be essential for scaling up COVID mRNA-1273. Having produced here over 100 GMP
`batches, in addition to thousandsof preclinical and development batches, give us a good and tremendousconfidencethat we can deliver on our
`mission to manufacture high quantities of mRNA-1273 COVID vaccine.
`
`Next slide. As a reminder, our processis not a traditional biotech monoclonal antibody that requires huge bioreactors. We do not needcells to
`produce mRNA.No needfor product-dedicated plant. Having our manufacturing plant and being an [ancillary] cell-free process allows us to scale
`very fast.
`
`Next. Now we are producing a commercial engine. Andthis is in addition to the ones we have before and wewill be able to produce hundredsof
`millions of dosesin this infrastructure. Also importantly, this capacity can be used beyond the COVID vaccinefor other products that we commercialize
`afterit. We believe this experience is a competitive advantage.
`
`Next slide. So how are wescaling up? Once wedecidedin our industrial scale, we are replicating units of the same equipmentinside our plant and
`thoseof our partners. Having the samekit allows for easier replication, faster technical transfer and a much reducedrisk of surprises among[different]
`plants.
`
`Next. We have designed2 different supply chains using this concept. One in the U.S.for the U.S. and another onein Europe for international markets.
`The magnitudeofthis effort required us to partner with very reliable companies. So let me expand aboutthemin the next slide. So these companies
`have -- are very experienced commercial manufacturers,all with extensive experience launching and supplying medicines worldwide.
`
`Lonza. Lonza will help Moderna to produceactive ingredients, both in the U.S. and in Switzerland. Lonza has an impressivetrack record of healthy
`pharmaceutical companies with more than 45 BLAs, MAAsto market, commercializing in more than 80 countries and with many expedited review
`designations.
`
`Catalent; for formulation,fill and finish in the U S., definitely, one of the top aseptic manufacturing companies producingvials with isolated
`technology.
`
`ROVIfor formulation,fill and finish for international countries. Experienced in 65 markets including the U S. and with a lot of vaccine experience.
`Weare alsofinalizing agreements with other partners. | cannot thank enough our manufacturing partners. | have not seen in my career such a
`tremendouscollaboration and purpose from employeesofdifferent companies.
`
`Next slide. So how are we designing the productto be in the market? Wewill have multi-dose vials with 10 dosesin eachvial. 10 vials will go into
`a carton,cartonswill go into a case andcasesinto pallets. The pallet will be stored at negative 20 degrees Celsius or negative 4 Fahrenheit, which
`is the normal, a standard freezing temperature. Frozen food and freezers at hometarget the same temperature. Weall are familiar with it.
`
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`©2020 Refinitiv. All rights reserved. Republicationorredistribution of Refinitivcontent, including by framing orsimilarmeans,is prohibited withoutthepriorwritten
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`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 5 of 5 PageID #: 12604
`Case 1:22-cv-00252-MSG Document 193-6 Filed 01/16/24 Page 5 of 5 PagelD #: 12604
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`SEPTEMBER 17, 2020 / 12:00PM, MRNA.OQ - Moderna Inc Corporate Analyst Meeting
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`Next slide. We are designing the supply chain for COVID mRNA-1273to befully flexible. We expect the product to be stored at minus 20 degrees
`Celsius for a minimum of 6 months. As we get morereal-timestability information, we may go beyond 6 months.In addition, the product can be
`up to 7 daysin the refrigerator at positive 2 to 8 degrees Celsius. Again, this could be longer once we have morereal-time stability.
`
`In addition, the product can be up to 1 day at room temperature during administration.All of this allows to use existing market infrastructure.
`Finally, the productis ready-to-useas is. No dilution or special handling is required.
`
`Next slide. By using existing infrastructure, there is flexibility to send different quantities to the different needed locations, bigger quantities to
`large immunization centers, or for instance, a single pack to a small nursing homeor doctor'soffice. For immunization, just draw 0 5 mL andinject.
`
`Next slide. COVID mRNA-1273is a liquid vial. The other vaccinesin our pipeline are designed to be lyophilized or freeze dried as you referto call
`it, which could allow for 18 months or moreofrefrigerated conditions, positive 2 to 8 degrees Celsius. For instance, our CMV vaccine candidateis,
`as you can seealreadyin lyo form.
`
`You maybeasking yourselves why wedidn't go lyo for COVID 1273. While there is not enough lyo capacity in the world for a global pandemic of
`this nature to be producedin lyo.| can alsotell you that we have an active technical development program,intended to havea stable to 2 to 8
`degreeliquid formulation.
`
`Next slide. Our CM and C readinessis well advanced for a BLA and emergency use authorization.First, we count with a very experienced management
`team with an impressive track record in product development, BLA preparation and launch and running commercial operations. As discussed
`before, we are privileged to have second to nonepartnersto help usin our mission. Third, we have validated our first commercial scale, and the
`next scale is well in progress.
`
`Our manufacturing plant has produced above 100 GMP mRNAbatches. Andfinally, we are having real-time and constructive dialogue with
`regulators.In the right-handside, you can see a picture of real COVID mRNA-1273vials intended to go to market.| have personally brought numerous
`products to marketin my 30-year career. And I'm very confident to make this one happen,too.
`
`Next slide. We are on target. We are bringing togetherthe infrastructure to produce 500 million to 1 billion doses per year. We are alreadyactively
`manufacturing for market use, andsofar, our scale-up and documentationis on track to deliver.
`
`Next slide. Before | hand it over to Stephen, | want to sincerely thank employees, manufacturing partners, supplier partners and regulators and
`governmentagenciesfor an incredible collaboration andtireless effort. This is indeed unprecedented. Stephen?
`
`Stephen Hoge- Moderna, Inc. - President
`
`Thank you very much,Juan. SoI'd like to take the closing few minutes of our prepared remarks today and update on a couple ofactivities in the
`new research and developmentspace.
`
`I'll remind you that we generally do nottalk aboutall of our preclinical research and our extensive investments there, but we have a longstanding
`and major strategic commitmentto continue to push the boundaries of how weuse our MRNAtechnologies and to create an expanding pipeline
`in all of our core and noncore therapeutic areas. But we do regularly update when wedo deals. Andin this case, in particular, we announced 2
`partnerships today that we wantedto provide a little more context onit.
`
`So the first on Slide 158 is a new partnership with Vertex, expanding on our multiyear collaboration with them in the field of cystic fibrosis. This
`new announcementthat was made yesterdayis aimed at expanding into gene editing and gene therapy technologiesas an alternative approach
`to treatmentofcystic fibrosis. AndI'll provide in just a minute,a little more context of how these2 different approachesto addressing this disease
`will operate in parallel and the difference in to doit [personally].
`
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`©2020 Refinitiv. All rights reserved. Republicationorredistribution of Refinitivcontent, including by framing orsimilarmeans,is prohibited withoutthepriorwritten
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