Q4 2022 Moderna Inc Earnings Call
The conference will begin shortly.
Yeah.
Good morning, My name is Kevin and welcome to <unk> fourth quarter 2022 earnings call. At this time all participants are in a listen only mode. Following the formal remarks, we will open the call for your questions to ask a question during the session. Please press star one on your telephone. If your question has been answered or you wish to withdraw your question. Please press star one again, please be advised us.
Call is being recorded at this time I'd like to turn the call over to Levine to look to our head of Investor Relations at <unk>. Please proceed.
Thank you Kevin Good morning, everyone and thank you for joining us on today's call to discuss <unk> fourth.
<unk> fourth quarter and full year 2022 financial results and business update you can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investors section of our website.
On today's call are Stefan <unk>, our Chief Executive Officer, Stephen Hoge, Our President ARPA Gray, our chief commercial officer, and Jamey mock our Chief Financial Officer.
Before we begin please note that this conference call will include forward looking statements made pursuant to the safe Harbor provision of the private Securities Litigation Reform Act of $19 95. Please see slide two of the accompanying presentation and our SEC filings for important risk factors that could cause our actual.
Foreman or results to differ materially from those expressed or implied in the forward looking statements with that I will now turn the call over to Stephane.
Good morning, or good afternoon, everyone.
Come to our Q4 2022 conference call.
Today I will start with a quick review of 2022.
Stephen will then review our clinical programs before I'll start gives an update on our commercial progress and plans.
Jimmy will then present, the financial results and I will come back to share some thoughts on where we're heading.
We are pleased to report today revenues of $19 3 billion for fiscal year 2020 through gap.
GAAP net income of $8 4 billion and GAAP diluted earnings per share of <unk> 12 cents.
Cash and investments Brian fees of $18 2 billion at the end of the year.
We continued our disciplined capital allocation policy reinvesting fifth company.
In 2022, we invested $3 3 billion in R&D, our highest will available any investments ever.
We invested $1 1 million in SG&A and 400 million in capital investments.
We made the investments <unk> made meaningful access to new gene editing enzymes and carriers might in oncology.
We are not an investment in Ctrip ex an acquisition of OE zero in Japan to continue to streamline our manufacturing processes.
And just yesterday, we announced a collaboration with <unk>.
$3 $3 billion, where we tend to shareholders through a buyback of 23 million shares.
I am proud of our strong results by our team in 2022, as we made history with the number of outstanding accomplishments for patients.
In respiratory vaccines, we develop new products with remarkable speed getting them on it were $73 two one for against Omicron via one the strained recommendation by debit ratio amounted to $73 222 against Omicron EFI. This trend by the U S every year.
We develop 12, 70% of our total two in less than two months.
We're able to protect millions of people from potentially severe disease, resulting from new Colgate strengths.
Our RSV vaccine went from phase one stop two phase III data in 24 months.
Met its primary efficacy endpoint in the phase III trial.
In oncology, our personalized cancer vaccine was our first demonstration of positive results from an M&A cancer treatments in a randomized clinical trial.
In reality it is appropriately academia program showed early positive clinical results in a repeat dose chronic disease, setting and reducing metabolic decompensation event in patients.
And we announced with <unk>.
Book will become the first effective inhaled <unk> therapy in humans as a partner of ethics and fill the phase one trial music all technology in the therapy for cystic fibrosis patients will access the FTR propane.
Finally, we had our first ESG data and published our first ESG report, providing additional transparency in how we conduct our business.
I wanted to take a moment this morning to touch on physician Executive Committee.
As we announced in late 2020 to Marcello Damiani decided to retire as chief Digital officer after more than seven years with the company.
Marcelo join without before first the clinical trial.
And we are today.
Trust company as a victim of his ability to scale digital resources.
I am grateful to Marcelo for his contribution during the early years of Madonna.
I am excited to have worked already we bred mirrors since early January <unk>.
<unk> brings a wealth of enterprise solution and platform operation experienced in several of our top technology companies.
This will be instrumental as one of our scaled into a fully integrated biotechnology company.
I want to also share we viewed upon address.
Currently president of strategic partnership at the product expansion has informed me of his intention to retire and will be retiring at the end of May.
<unk> built a tremendous for oilseeds, joining without that in 2017 from Novartis, where.
He led all of our manufacturing program.
<unk> is more than our chief technology operations and quality of yourselves. When you did the manufacturing from an early stage clinical development company.
To a commercial company.
I believe <unk> is a historic job with this team in 2020.
So scalable down that for global commercial launch during a pandemic.
It is literally unbelievable that he led the team from having made across our entire portfolio less than 100000 doors in 2019.
Two more than $800 million in 2021.
All during pandemic.
We had hundreds of millions of people across the globe, who received a modern a COVID-19 vaccine Boeing one of gratitude.
I believe very few manufacturing leaders could have led to such an achievement.
Most recently, one thats focused on building out our organization to ship Baltimore that growing pipeline legal efforts in producing a personalized cancer vaccine.
Jr, who used to work for one of Novartis as joined US in early fall.
And has been leading manufacturing since then I am thankful part one was ensure a very smooth transition, helping Joe every step away.
Upon his retirement at the end of May one responsibility with tradition to Stephen Hoge President of Madonna to integrate PCV across all functions with gel is in the manufacturing of PCB for multiple phase threes and of course for getting commercial already.
On behalf of someone asking me I want to thank <unk> for his continued leadership and wish him and his wife Marina divest of a well deserved retirement.
I am deeply thankful to have constant theme for so many years as a partner with Madonna.
And more importantly, <unk> has a frame and the metal we will miss him.
The company continues to expand at a rapid pace.
Pre commercial COVID-19 vaccine products, we will for development programs in phase III, we hope to expand our commercial portfolio very soon.
Overall, we are for care programs underway, we have a team of 3900 team members.
And now present on the ground and 16 commercial subsidiary across Americas, Europe , and Asia Pacific.
18 billions of off cash balance at the end of the year is enabling us to scale across research.
Clinical development manufacturing commercial engine with that let me now talk to Steven.
Thank you Stefan good morning, or good afternoon, everyone. Today I'll review, our progress against our key clinical programs I'll.
I'll start with our respiratory vaccines, we have approved are phase III development programs against the big three respiratory viruses, COVID-19, RSV and influenza.
Some additional data on these in a moment, including some presented this morning on our older adult RSV phase III trial.
We're also advancing our portfolio of next generation programs against these viruses, including mrna 12, 83, which is a next generation COVID-19 booster that as refrigerators stable.
We also have multiple next generation flu programs will seek to increase the breadth of coverage against influenza by adding additional antigens that are not present in currently available flu vaccines.
Lastly, our respiratory portfolio includes a large number of combination vaccine to provide protection against multiple respiratory pathogens, which has advantages for many stakeholders, including health care providers payers and consumers. These include combinations of Covid flu and RSV as well as two pediatric vaccines that include additional <unk>.
Irises that are important in children, including <unk> and PIV three.
As we prepare for endemic covered in 2023 and beyond we wanted to briefly recap the recent verb Pap committee discussions and recommendations.
At the January <unk> meeting the committee voted to harmonize the primary series and booster dose vaccines, which is an important step to simplify future guidance.
FDA also indicated that it expects to convene per pack determined vaccine strain composition for the 'twenty three 'twenty four season in the second quarter of this year.
We believe that our mrna platform has demonstrated the ability to deliver variant match vaccines on accelerated time prices and we believe we are therefore, well positioned to deliver whatever composition update the FDA and other public health agencies recommend.
Now moving to RSV.
As you know we shared the topline results from our phase III RSV study in older. Adults earlier this year and today, we shared additional data that was presented this morning at RSV VW.
Topline results, we've seen are incredibly encouraging and we're grateful to the FDA for breakthrough therapy designation for mrna $13 45, which further emphasizes the significant health impact of RSV in older adults and the high unmet need.
And the topline data presented in January now more than a <unk> 45 demonstrated 83, 7% vaccine efficacy and the primary endpoint of lower respiratory tract disease with two or more symptoms.
<unk> 45 was found to be generally well tolerated.
And there were no safety concerns identified by the data and safety monitoring board.
And the data presented today at RSV VW, we confirmed that <unk> 45 was well tolerated and has an acceptable safety profile.
Solicited adverse reactions were mostly grade one or grade two and to date, most solicited adverse reactions were mild to moderate with the most common adverse reactions being injection site pain headache, My Alger and El trial Gen.
Vaccine efficacy was consistently high across all age groups and in participants with preexisting comorbidities that are at highest risk.
Please refer to the scientific and medical meetings section of them Madrone Investor Relations web site to see the full RSV VW presentation.
And we're very encouraged by these data and look to look forward to file a biologics license application with the FDA in the first half of 2023, if things proceed.
With the option of using a priority review voucher, we might see regulatory action on this filing in late 2023 early 2024.
Now moving to flu.
Last week, we shared with you data from our phase III Immunogenicity and safety study in the Southern Hemisphere study 301.
In this study are first generation vaccine mrna 10, 10 demonstrated superiority of <unk> zero conversion rates for influenza, a H <unk> III and <unk> and superiority on geometric mean titers for <unk> III and non inferiority on geometric mean titers for each one.
Hey, Ken 10 did not meet non inferiority on zero conversion or titers for the two important that these strengths.
Our separate phase III efficacy study in the Northern Hemisphere study <unk> has now accrued over 200 confirmed cases of influenza like illness.
All of which are influenzae.
Which as expected this was expected as the overwhelming majority of influenza burden in older. Adults is caused by influent bay, including over 95% of hospitalization and the most recent season.
Now based on the case accrual in Petri of two we now expect the independent SMB will review the first interim analysis of efficacy in that study in the first quarter of this year.
Now, let's take a look at our latent vaccines on slide 14.
Our CMV vaccine is in an ongoing phase III study and we've begun dosing participants in the phase one two adolescent dose ranging study.
EBV vaccine to prevent infectious mononucleosis is in phase one while our EBV vaccine to prevent long term sequela of EBV is in preclinical development.
We have two HIV phase one trial is ongoing and our HSV vaccine is in preclinical and finally, our <unk> program has begun dosing in purchase events in our phase <unk> study, which I'll discuss further on the next slide.
The <unk> study is a phase <unk> randomized safety and Immunogenicity study evaluating mrna $14 66 68 against <unk>.
This is a relatively large study enrolling 500 zero negative older adults in.
In multiple doses and dosing intervals in a 12 month study follow up.
Over 35% of participants will be 70 years and older which is in line with the largest disease burden of shingles.
Now, let's take a look at our therapeutics portfolio on slide 16.
I'll highlight a few of the programs.
We recently reported strong top line data for our personalized cancer vaccine, which I will talk to in a moment.
In immuno oncology, we are working to address disease burden beyond PCV with our checkpoint and triplet programs both of which are in phase one trials in various tumor types.
In rare diseases, our phase one two <unk> program continues to enroll patients and we're looking forward to selecting a dose expansion arm I'll provide a brief update on that in just a moment.
Earlier this year, our partner vertex announced initiation of a phase one trial in cystic fibrosis patients, which is our first inhaled pulmonary mrna therapeutic program and in cardiovascular we announced relaxin has initiated dosing in the phase one study both of these study initiations represent important milestones for <unk> as we expand our modalities and therapeutic area.
Yes.
Now in December we shared exciting topline data from our phase III personalized cancer vaccine program testing the combination of PCV and Keytruda against Keytruda alone and the setting of adjuvant melanoma Keytruda.
Keytruda is the standard of care in that setting.
In this study we showed the addition of our personalized cancer vaccine treatment in more than a $41 57 to keytruda reduced the risk of recurrence or death by 44% compared to Keytruda alone.
This was the first demonstration of efficacy for an investigational mrna cancer treatment in a randomized clinical trial and we are pleased to announce a $40 57 has received breakthrough therapy designation from the FDA.
Along with our partner Merck we are excited about these results and expect to launch multiple late stage confirmatory studies for <unk> in 2023, starting with melanoma, and then moving to non small cell lung cancer.
We are planning to explore additional indication indications for $41 57, where we believe there's a strong biologic rationale for immune stimulating approaches. These.
These include early stage in metastatic savings and will include indications, where keytruda is not yet approved.
Finally, we expect to release full data from our phase II study at an oncology meeting this spring and in an upcoming publication.
And moving to PAA since our update with our at our R&D day. The PAA Paramount study has made good progress our fourth cohort is now fully enrolled and we are currently enrolling patients in our fifth cohort, which doses at 0.9 milligrams per kilogram every two weeks.
We are encouraged that to date.
Any dose limiting toxicities and we're also encouraged that all patients and families have opted to continue treatment electively in our open label extension study across all prior dose cohorts.
Now the next step in this trial will be to review available data and determine a dose for expansion.
I'll now hand, the call over to ARPA, Gregg, who will provide an update on our commercial activities.
Okay.
Thank you Steven and good day to everyone I will start with a review of sales on slide 20.
In the fourth quarter total product sales were $4 $9 billion.
In the U S. Our sales of our $1 billion sales in Europe approximated $2 2 billion in sales in the rest of the world for $1 6 billion.
We ended the full year strong, but total product sales for 2022 of $18 4 billion.
In the U S for the full year were $4 four sales in Europe were six seven and in the rest of the world, where seven 3 billion.
We are reiterating approximately $5 billion in carpet sales for delivery in 2023 from our currently signed advanced purchase agreements and apparel.
And when do you expect additional sales from key markets, such as the U S EU and Japan.
Slide 21 summarizes the current composition of sales for 2023.
We have advanced purchase agreements from Canada, Kuwait, Switzerland, Taiwan, and the United Kingdom.
We expect these sales to be recognized upon delivery of vaccines in the second half of 2023.
Additionally, we expect further sales from deferrals from 2022 contracts.
These deferrals are from the countries listed on this slide and are expected to be mainly recognized from deliveries in the first half of 2023.
Together these advanced purchase agreements and just first half total approximately $5 billion in sales for 2023.
We do expect additional sales from key markets, including the United States, EU, and Japan, as well as Australia and other countries in Asia and Latin America.
In the U S contracting discussions with commercial customers are ongoing and we will provide visibility into expected U S sales at a future date. After we complete these discussions.
And our discussions with commercial customers in the U S. It is clear to us that our customers recognize that COVID-19 is still a substantial health burden.
Throughout 2022, Covid continuing to be a leading cause of hospitalizations and death.
If you look to the chart on the left hand side, what Youll see here is data available through September 2022.
<unk> the third leading cause of death in the United States only after heart disease and cancer.
And if you look today as for ATM side.
Four months for the fall and winter season from October one 2020.
Three hospitalizations from carbon in the U S are nearly 450000.
More than doubled since flow and nearly three times higher than RSV in that same four month period.
There continues to be a clear need to protect against and payer covenant factions and our customers recognize that.
Given this need we estimate the U S fall 2023, COVID-19 market volume to be approximately 100 million doses.
We basis assumption at Youre looking at 2020 to him vaccination rates and including potential recommendation for two dose blister series for high risk individuals.
Taken together the doses administered represent roughly 30% of the U S population.
A few factors that can impact us volume.
<unk> viral evolution regulatory recommendations as well as vaccine understanding and uptake by consumers.
Hey, Darren this commercial organization is prepared preparing for that transition to a commercial market in the U S.
Let me now take you through how we have been preparing to go to market.
First and foremost we are committed to access which I will explain in greater detail in just a moment.
To ensure coverage of our vaccine we are engaged in discussions with private customers as well as public entities, such as the VA CDC and the department of defense.
We are increasing awareness and educating consumers as well as health care providers about the benefits of booster vaccination.
Linemen with public health agencies, such as CDC and CIP.
We are reaching healthcare providers and consumers through innovative digital outreach program.
We have built the infrastructure needed to fulfill customer orders and shipments.
And our commercial and medical organizations have been scaling to execute on this plan and we are ready for the transition to a commercial market in the United States.
Very importantly, as we enter the commercial phase of the Anthemic cobot market.
I want to emphasize our commitment to vaccines access for everyone in the United States, regardless of their ability to pay for.
For all insured individuals in the United States consistent with preventative health services requirements.
Reimbursement roles will be sustained.
As an AC IP recommended vaccine <unk> kind of been vaccine will continue to be available for zero out of pocket costs for individuals with insurance.
And we are proud to say that for uninsured or underinsured people in the United States Mint Arnaud will be launching a patient assistance program that will provide COVID-19 vaccines at no cost.
Let me now summarize our content vaccine outlook.
In 2023 weeks that current sales and approximately $5 billion.
In addition, we are expecting sales from U S commercial market orders EU, Japan and other countries.
We will provide visibility into these sales after we complete ongoing discussions with governments and with customary.
We can recognize cover continues to be a burden to health care systems and this continues to be an important point as we discussed the value of booster vaccination with our customer.
In the U S. We expect commercial market volumes to be approximately 100 million doses in 2023.
<unk> commercial organization is prepared for the transition to a commercial endemic market.
Last but not least we are committed to patient access in the United States.
I now want to turn to another launch in the respiratory vaccine space that the commercial team is preparing for our RSV vaccine in 2024.
As you heard from both Stefan and Steven earlier, we are very pleased by our phase III RSV vaccine results.
Stephens organization, we will be filing for the approval soon and we expect we may be approved in late 2023 early 2024.
With the potential approval fast approaching I am very excited for the RSV vaccine launch and I want to provide additional color into the launch cloud.
The RSV launch will leverage the existing commercial infrastructure that is already in place for that and we will continue to invest to support it ensuring strong execution.
Both covenant RSV markets overlap considerably as you look at our target customers as well as potential target patients and audiences.
And we will leverage this overlap between the two markets.
We will ensure awareness of RSV disease, and the associated economic burden of RSV in older adults across key stakeholders.
Such as health care providers and payers.
Upon approval of our RSV vaccine, we will educate consumers on key attributes of our vaccine.
These planned activities will be initiated in 2023, and then full forest upon approval.
We have the added benefit of an in place commercial infrastructure built for Covid.
Many of these resources can be leveraged for flu as well into the future.
I look forward to keeping you updated on our progress throughout this year.
And with that I will turn it over to Jamie.
Thanks, Jennifer and Hello, everyone.
This morning, I will cover our 2022 financial performance and provide a framework for our 2023 financial outlook.
Moving to our fourth quarter results starting on slide 29.
Total product sales decreased by 30% year over year to $4 9 billion.
The decrease in 2022 was mainly driven by lower sales volume compared to overall higher demand in the prior year.
Cost of sales was 39% of product sales compared to 14% of product sales in 2021.
A key driver of the increase in cost of sales as a percent of product sales was a catch up royalty payment to the national institutes of health or NIH, a $400 million.
Representing 8% of product sales in the fourth quarter.
In December 2022, we entered into a non exclusive patent license agreement with the National Institute of allergy and infectious diseases and Institute or center of the NIH.
And certain patent rights concerning stabilizing pre fusion Corona virus spike proteins and.
And the resulting stabilized proteins for the use in COVID-19 vaccine products or <unk> technology.
Research and development expenses were $1.2 billion, which increased by 87% versus prior year <unk>.
The increase in R&D spend continues to be driven by our clinical trial expenses, particularly with our phase III studies for RSV seasonal flu ncnb.
The increase in R&D was also driven by the acquisition of a priority review voucher and an increase in personnel related costs due to increased head count.
Selling general and administrative expenses were $375 million also reflecting an increase of 87% year over year.
The growth in spending was primarily driven by continued investments and personnel and outside services and supportive are marketed products and company build out.
The effective tax rate was 11% compared to 10% last year.
After tax net income decreased by 70% to $1.5 billion.
Deluding earnings per share in queue for decreased by 68% to $3 and 61.
Now turning to our full year 2022 financial results on site 30.
Total product sales for the full year, 2022, or $18.4 billion, an increase of 4% year over year.
The growth was mainly attributable to customer mix in a higher average selling price in 2022 in certain markets.
Cost of sales was 29% a product sales compared to 15% of product sales last year.
The increase was driven by higher writedowns for access and obsolete inventory related to our COVID-19 vaccine.
Utilize manufacturing capacity and losses related to future purchase commitments for raw materials.
The key drivers for these charges are similar to the drivers in queue for.
Cost associated with surplus production capacity overall lower demand for the year in particular from low income countries and.
Rapid product demand shift from our original vaccine to omicron targeting COVID-19 bivalent boosters.
The previously mentioned catch up royalty payment NIH, a $400 million is also a driver of the increase year over year.
The effective tax rate was 13% compared to 8% last year. As a reminder, we had a net operating loss carryforward, a $2.3 billion at the end of 2020, which resulted in a non-recurring benefit to the reported tax rate in 2021.
After tax net income of $8.4 billion decreased 31% versus prior year.
The decrease of net income was primarily due to higher cost of sales hire other operating expenses and a higher effective tax rate.
Diluted EPS decreased 29% to $20.12.
Now turning to cash in cash deposits on slide 31.
We ended 2022 with cash and investments of $18.2 billion compared to $17 billion at the end of the third quarter.
The increase was driven by our commercial activity.
Cash deposits for future product supply reduced from $3.8 billion at the end of the third quarter to 262 $6 billion by the end of the year.
Now turning to slide 32.
I wanted to give an update on the progress we have made on our capital allocation priorities are top investment priority has been and will continue to be reinvesting in our base business across multiple areas.
Research and development spending increased 65% year over year from $2 billion in 2000 $21 billion to $3.3 billion in 2022, and we are projecting an additional increased to approximately $4 $5 billion in 2023.
The clinical data from our PCV RSC and flew trials were encouraging.
And further validate the potential of our mrna technology.
We are also investing in our digital capabilities. The commercial built out of the organization as well as expanding our manufacturing footprint, we plan to significantly accelerated our capital expenditures in 2023 as.
As we expand both our international and U S manufacturing footprint.
Our second investment priority is to seek attractive external investments in collaboration opportunities that will enable and complement our platform.
We've recently announced several new transactions and I'm happy to report that we have successfully closed our acquisition of aura Cero genomics and the first quarter of 2023.
<unk> is a great example of the companies we are evaluating to enable our mrna platform.
It will create substantial value from both the speed and cost viewpoint and impact are preclinical clinical and commercial pipeline for years to come.
Our collaboration with life at which we announced yesterday is another example of for an attractive external investment opportunity.
We believe the combination of Madonna's mrna platform with life at its proprietary Jean editing technologies, including based editing capabilities as the opportunity to advance potentially life transformative or curative therapies for some of the most challenging genetic diseases.
We are in multiple active discussions regarding additional external collaboration opportunities and we will be disciplined in our approach.
After evaluating internal and external investment opportunities, we dentist as additional users of cash and.
In 2022, we repurchased 23 million shares for $3 $3 billion at an average price of $143 per share.
And we have $2.8 billion a share repurchase authorization remaining.
Now, let's turn to our 2023 financial framework on slide 33.
As I mentioned earlier, we currently have Covid vaccine sales of $5 billion contracted for delivery in 2023.
Also we are actively working on preparing for the private market and government contracts in the U S and additional contracts for Europe , Japan and other key markets.
To help help you with your modeling purposes, we expect first half twenty-three sales to be approximately $2 billion.
Our total cost of sales includes the cost of goods manufactured third party royalties as well as logistics and warehousing costs.
We expect full year 2023 reported cost of sales to be 35% to 40% of sales.
This includes royalties of approximately 5% of sales, which are payable to upenn self scrip for modified chemistry licenses and deny add an NIH for the two P license that I mentioned earlier.
The increase in cost of sales as a percent of product sales compared to 2022 is primarily driven by presentation mix change as.
As we moved from a pandemic too endemic setting with single dose application significantly increasing in volume.
Longer term as the endemic market normalizes, and we add additional respiratory and other products. We expect our cost of sales as a percent of sales will significantly decrease in the rates were experiencing in 2000 2003.
Through R&D and SG&A, we expect full year expenses to be approximately $6 billion with approximately four $5 billion in R&D.
The increase is driven by our maturing development portfolio and the global scale up of our company.
We expect a negligible provision for income tax in 2023 and.
And finally, we expect capital expenditures of approximately $1 billion. The increase is primarily due to investments and expanding our manufacturing footprint.
This concludes my remarks concerning our financial performance and I will turn the call back over to Stefan Thank you Jamie Alpine Steven.
Let me share some thoughts with where we're heading.
I'm really excited to see him on the platform and the investments we have made in science over the last 11 years lead to sexual promising pipeline.
We anticipate a number of important developments.
Let me stop our first franchise respiratory vaccines.
And coming to boost sales were working for the switch to where U S commercial market and we anticipate being able to quickly meet the fall of 2023 market needs updated vaccines after via fax and the FDA make this transaction in the spring of 2023.
We've got to submit to always the vaccine for regulatory approval in the first half of 2023.
And is your throat mappah would be ready to launch the vaccine in late 2040 already 24.
Can you prove vaccine for one of them is fair amount <unk> face pre trial, the data and safety monitoring board is expected to completed the interim efficacy analyses in the first quarter of toys away for Ya.
While frequent franchise latent virus vaccine.
It is progressing very weird, we have broad spectrum of programs.
Large CMV phase three study, we look to complete the enrollment.
EBV HIV.
H I V and <unk> programs on Nick's My son will be phase one data.
Turning prescribed thirty-seven Jamie review the microphone for <unk> programs.
4% of cancer treatment, we expect to start of phase three study in partnership with milk and advancement on the map and we expect to rapidly expanding to additional cumulus types, including non small cell lung cancer.
Full price to data will be presented as an upcoming encore he meeting and provision of top quality medical drawn.
In PA, we plan to select those and begin the expression of a phase two study.
And I mean, we would have paid once with data.
The next milestone for heart failure, perhaps equal acting would be phase one data in patients.
<unk>, our partner of ethics expects to complete it single ascending go study in any shape or multiple has any of those studies.
To continue to be the best version of Madonna, We've established seven priorities for 2000 2003.
<unk> number one.
<unk> operational and select plan for <unk> 2000 for your project.
The number two.
And Ah revolve seasonal risk referee vaccine franchise.
The number for Ya.
Aboard campaign of cancer vaccine studies.
Right before adventure, where metabolic disease programs.
The fire driver upbeat advancements and growth of latent the vaccine portfolio.
<unk> did you ever have a next generation pipeline and platform.
As we said before this is just the beginning.
And president of a seven b, the culture of perpetual learning and strengthen our processes and ecosystem as we want to schedule a company to another level.
Oh, sorry, 39, some key dates for 2023 more than that <unk>.
Equity Levan, we'd be annual vaccine there.
September 15th annual R&D, there, where we presented development pipeline kobe's.
And instead of a seven we've just begun the ESG data.
Now that we have delivered on the promise of them on the science, we our first product lost.
Omission as equal.
Our mission is to deliver the greatest possible impact to people who are among the medicine.
We are passionate both of our ability to have a profound impact on humanity.
We believe we have a technique to eliminate awkwardly reduce human suffering caused by risk preferably Volitive later dorothy's.
<unk> <unk> and a growing list of the cities.
We believe we can have an impact on the history from us that we offer I predict Phil and then we've got clean editing programs.
This is just the beginning.
Without the Tiemannite Pete.
It will now take your questions operator.
Thank you ladies and gentlemen, if you have a question or comment at this time. Please press star one one on your telephone. If your question has been answered you wish to move yourself from the queue. Please press star wouldn't want again, one moment for our first question.
First question comes from Shelby and Richter with Goldman Sachs. Your line is open.
Good morning, Thank you for taking my question.
Speak with a regulatory strategy.
We'll get into that.
Strange.
And if you're confident in <unk>.
Awesome.
Okay.
Yeah.
And I'll take that thank you shall be for the question.
Look I understand we're still have incomplete information to provide guidance on the regulatory strategy.
At this point, we are looking to the efficacy results from the Pizza to study that I described which will guide us on on that filing strategy.
Note that advocacy ultimate demonstration of of non inter efficacy against an approved vaccine was always going to be required for full approval and that the only thing that you could do with immunogenicity, we'd be an accelerated approval path with an obligation to subsequently demonstrate efficacy.
And so right now we are actually very encouraged the data that we've seen from our Immunogenicity and safety study, which was run in the southern Hemisphere Patrial one show superiority on three out of four and points for the influenza a strains which drives the overwhelming majority of disease in the population of interest you're older adults and account for over.
99% of the cases in our efficacy study and so that first interim.
<unk> analysis that will let you know in Petri O two.
Will involve over 200 cases, and 9% of them are influenced.
And it will be our first.
A chance to really see the performance of the vaccine in terms of prevention of influenza like illness.
From <unk>.
That is the first interim analysis and so it's quite possible as you would expect in any efficacy study and we've all got some experience now with these respiratory FC studies that we may need to go to a second subsequent interim analysis and crew, even more cases to demonstrate either known inferiority or superiority in that study and.
And so what we'll do is we will wait for the results from the D. S. M B, the infinity SMP and guns from that and based on those results. Obviously, if we do see efficacy that is the gold standard for proceeding with regulatory filing in full approval if we.
We do not yet meet that threshold then we'll be looking forward to subsequent interim analyses in that study.
Alright, thank you.
One moment for our next question.
Our next question comes from gene away with Barclays. Your line is open.
Thank you just quickly follow Sammy question do you need to show superiority in order to receive approval.
Cassini study.
Quickly on the revenue.
Take out correctly.
The system Comcast 5 billion, mainly will be in the second half twenty-three if that's the case.
Fantasy that total called new revenue in 2020 <unk>.
Seven.
Regarding the 2 billion in the first half 20th see how much you will be <unk> I I would have to ask.
100 million doses.
What could be your issue.
Great I'll take the first question. Thank you Gina for that so first on superiority you do not need to demonstrate superiority to get a flu vaccine approved that's all precedented noninferior efficacy is the threshold.
Our goal, though over time is absolutely to develop a superior influenza vaccine and.
And so if we don't see it with a first generation product, which is more than a 10 10 I would note that we have for other programs flew programs in development different stages of clinical trials that are looking to do even better than perhaps a flu mrna 10, 10 and he'll go over time would be to demonstrate that we have a superior influenza vaccine.
But it is not actually required.
For approval Noninferiority should suffice.
Now turn up an art for the other questions sure Yeah I can take me a second question.
<unk> D. I total sales we are anticipating about 2 billion of the 5 billion in the first half of the year.
And none of that to billing is coming from the U S market the remaining.
<unk> purchase agreements that we have $3 billion will be coming in the second half of this year now that $5 million has just a total that we have advanced purchase agreements as long as deferrals from 2022, we do anticipate additional sales from day, you ask Japan, you in other markets and we believe.
The majority of the sales will be in the second half of 2023.
Okay. Thank your market share regarding thank you Mister <unk>.
We we continue to believe in this John differentiated profile of our product we do not have any updates on market share projections asked me are currently in discussions with customers right now for fall 2020 attorney contracting.
Okay.
One moment for next question.
Next question comes from Matthew Harrison with Morgan Stanley Line is open.
Great. Good morning, Thanks for taking my question I was hoping to ask about the regulatory strategy for Ptv and specifically, how you're thinking about the potential for filing off the phase two datasets.
As well as how you're thinking about the timelines for enrollment in the phase III program and how that may impact the timeline for potentially filing off the phase two datasets. Thanks.
Great. Thank you master the question so.
We are obviously really pleased yesterday to announce that we received at the a breakthrough designation therapy for the for the P. C. D program and what that allows us to do is very rapidly accelerate our conversations with the F D. A and other regulators on the path forward profiling 41 57.
As you noted the fees to be studied that we've run is a randomized study compared against really the standard of care, which is keytruda alone.
And has already shown a quite significant benefit that 44% reduction in the rate of occurrence and <unk>.
<unk>.
And that studies on going and so we're continuing to follow over time and conduct additional interim analyses and it's possible that those in fact, we would hope that those data mature and continue to get stronger and stronger and so it is entirely possible that in our discussions under breakthrough with the F D. A and others that we will come up with a passport.
For beginning the filing process based on that phase two and potentially proceeding with an accelerated approval now as you know in this country and I think that's where your question is coming from as well as globally. If there is a path forward. There we haven't yet engaged with the F. D. A on because the breakthrough happened yesterday, but if there if there is a path forward there.
It would require us to rapidly enroll a confirmatory phase three study and in fact, there's more and more attention on perhaps requiring that those phase III studies be enrolled prior to accelerate approval and so for that reason ourselves in mirc are working really quickly now to try and stand up that confirmatory stage three melanoma study.
Enroll as fast as possible now, we're not ready yet to guy on how quickly that will be but we're fully aware of the fact that that in fact, if there is a path forward for accelerated approval. The enrollment of that phase three may may be gaming and therefore would want to have it enrolled as quickly as possible. So at this point we we.
Received the breakthrough designation, we're engaging with regulators and we're gonna try and develop that path forward, but it is theoretically possible that there was an accelerated approval path and that we would need to enroll that phase three study based on recent regulatory guidance more generally to the industry and working hard to make sure that we can do that as fast as possible here, while continuing to conduct a desert additional letterman L.
He's and see the maturity of this data continue to proceed and hopefully the strength of the of the benefit provided by the combination to be for.
Further about it.
Okay. Thank you one moment for our next question.
The next question comes from Edwards turned off with Piper sample. Your line is often.
Great. Thank you very much and thanks for all the details on the call today [laughter]. My question <unk> go back to flu form an interest with respect to the follow on.
Candidates, including I think the one that's pentavalent Hemagglutinin and then six Hemagglutinin and then also into the neural <unk>.
The candidates have abnormal <unk>, what should be our expectation both in times of timing for data here and how do you ultimately see your seasonal flu product of offering kind of evolving. Thanks.
Thanks for the questions. So let me start with the most advanced program offices are 10, 10 program, which we've talked about and we have done a update to that vaccine that we think will increase the b immunogenicity for those populations for whom that matters and we expected development too advanced that in clinic.
Study quite quickly that in combination with the efficacy data that we were just talking about with Petri O. Two probably is the most important information for guiding our next steps on the second generation products are.
Our multiple Sarah.
[noise] hexavalent.
Vaccines as well as the 10 2010 30 programs, which include neuraminidase. As you said are all in various phase one studies and as we've shown repeatedly hopefully over the last couple of years. We can proceed very quickly into subsequent phase III and pivotal studies once we once we select one of those candidates move forward, but the really <unk>.
<unk> gaining information is understanding how is our first generation product performing in terms of efficacy as a first mrna flu vaccines and so we are waiting for that information before proceeding forward, but we do expect that at least one if not multiple of the second generation products would move into subsequent pivotal studies phase three studies.
And in those cases, because we would be looking to demonstrate.
Some form of superiority either against a broader range of influenza strains or better protection against influenza like illness. Because we've included additional antigens. We would expect those studies to include folks immunogenicity and safety and efficacy and points as we move forward in soap.
We'll make a selection of which ones we might move forward based on the ongoing interim analyses of efficacy from our 10 10 program.
We don't have an otherwise.
Good points on which one of them before.
Great. Thank you very much.
One of them before next question.
The next question comes from Michael Jeffries Your line is open.
Good morning follow up on the flu vaccines and also about piecing question for Steven I guess that could you clarify do you have a hypothesis surround y strange or not not inferior and what the ramifications are for that.
Therefore, this flu vaccine, but I'll show for them.
Infection study and what that would mean for combinations.
So first of all just clarify what is going on that with the beach trained the ramifications for flu vaccine and then my second question John P. C B.
Obviously, we're excited about the adjuvant data, there's also a competitor or read it nowadays metastatic melanoma at the summer. So I wanted to understand how we should.
Compare and contrast that and if you could walk us through how to think about metastatic and and what competitors myself.
Thank you Michael for both questions. So so first on the flu on the beach.
We're still looking into the data.
And you're going to develop.
Develop a more complete picture of what we think happened in the influence of B.
Immunogenicity study I would note a couple of things that are important. The first is these are Atkins comparator studies and so when you look at Noninferiority on Seroconversion titers, it's important to note that were going against the standard.
Standard dose influenza vaccine active comparator in between the.
Phase two study and the phase III Southern Hemisphere study there were changes in the composition of those arcade comparators in the compared to us and says that can drive some different.
The second thing I would note that they were different populations. So we went from a northern hemisphere to a southern hemisphere.
And obviously that can drive some differences in background.
History of influenza illnesses.
But the third and perhaps maybe most relevant is we did expect that the influenza be neutralizing titers were lower as you remember we shared with a phase two data about a year ago, we didn't have a lower neutralising Hai titers for the insulin to be strange and for our older adults.
Influenza vaccine, we thought that was acceptable because at the end of the day. Our goal is only to achieve noninferiority not to demonstrate superiority.
Whereas for the influenza a strange we really wanted to maximize those neutralizing titers and potential for benefit because influenza a really is what drives illness in older adults, which is our first time I was a project.
So we did focus heavily on the influence a we were aiming at noninferiority on the influenza beats and as you said, we did not make noninferiority on those and will continue to pull it apart the reason as to why but we have already identified and update.
That would allow us to improve immunogenicity against the Beast to the extent that that that is important going forward not just in younger populations, but perhaps Vermont overall regulatory perspective, and so we've moved that update we're actually going to be evolving that in the clinical study very shortly here uhm and we expect that we'll be able to address that.
Lower immune Jameson that we saw on the beach quite quickly.
But as I said, a moment ago, what really matters is efficacy and efficacy against influenza disease and in this case, we we really do see that has influenced a related for our first generation product, but we will obviously be updating.
Important to be strange for other subsequent generations of products and it's important to note that that's really important is you get into pediatric populations were important to be is a bird disease, particularly in the.
Now on the question of P. C V.
We're we're pretty encouraged by the edge of melanoma data, we do have some early metastatic data as you as you will note from our part if there's one studies.
And in the phase two there was some please towards these as well in that study we did not conducted only in first line metastatic and so we're actually looking forward to understanding the performance of a competitive product in that space because it may actually identify an opportunity for us to move into.
Liam stages of treatment.
For now our approach has been to focus on places where checkpoint, including Keytruda, our standard of care and have demonstrated a really strong signal, which is why you see us expanding from adjuvant melanoma into adjuvant non small cell and ultimately will go first into other adjuvant indications were really think there is the most immediate.
[noise] benefit or biologic rationale for potential benefits that will be looking to demonstrate but obviously as others start to move into the space. If they show benefits in other lines of therapy. We will absolutely wanted to proceed very quickly and instructions as well. So we're looking forward to those results are more obviously, a bunch of them as everyone else well.
Thank you.
One moment for our next question.
[laughter].
The next question comes from caller Van Buren was count on your line is open.
Hey, guys. Good morning, Thanks, very much for taking my question.
RSV a few years from now do you expect it to be a two three or perhaps a four player market went including J&J and how do you believe that the Tolerability profile compares to others based upon the full data presented this morning.
Sure I'd like and maybe I'll take the first portion of that question.
At this point there are.
That's obviously three companies that have right out they're faced with pickle outcome studies, we're proceeding.
Right now the filing.
I think.
I don't I don't have a specific to you one day and Jamie the Harper can offer perspectives on that but it isn't that Nevada.
Dr program and and otherwise.
Still unclear about that regulatory passport now.
On the on.
On the question of Ah Ah reacted Union city Intolerably profile.
As we presented today, whereas our collaborator presented today at RSV W. We do see we think a favourable tolerability profile grade three adverse reactions with a local or some stomach or all below two per cent for any of the individual symptoms and actually compared relatively favorably with a P.
See bowling that arm, often maybe one and a half times as frequent as what we're seeing in placebo, which we think is a compelling overall wretchedness profile. We then thank the other parts of the benefits of product or obviously efficacy were incredibly pleased but if you look at the most common definition of cases.
So are you in the.
Respiratory tract disease involving two symptoms, which.
Which has been relatively consistent across the different products, we have seen very high up cause we needed, 3%, which really think is among the best and as we presented today that advocacy actually holds up beautifully as you look at older populations those over the age of 70 as well as those with high risk Comorbidities.
That would drive the majority of the expense associated with caring for patients older adults with respiratory disease from Mercy.
So overall.
You know, it's very difficult obviously to do cross trial comparison, and ultimately it will fall for public health officials to make those decisions, but we are really encouraged by both the efficacy intolerant profiles 13, 45, and look forward to to filing and ultimately too.
To the commercialization of that product.
Or would you like to add anything in terms of your perception of the market going forward.
Sure. So I would say, we do anticipate it being at least at three player market Ah, We estimate turnout fighter and J F. K. There is a possibility of a four player market and can J has a regulatory how far up in the air and do you know that.
Hi, Maxine.
Mmk Marta out there.
Thank you one moment for our next question.
Our next question comes from just far with J P. Morgan Your line is open.
Good morning, and thanks for taking my question.
Falling upon blue.
10, 10, just to be very clear.
Noninferiority any effort.
Northern Hemisphere study.
You think that mrna 10, 10 would be approvable in spite of missing on Noninferiority on the beach strain.
And related to that would you envision the approval only being for older adults.
And on.
RSV can you comment on any expectation for guessing frequency for your RSC vaccine.
How do you think about the value and potential pricing of that vaccine, maybe benchmarking off of other vaccines for that age group. Thank you.
Yeah. Thanks for those questions Uhm, So let me take the flu stuff first so.
Again, the the full approval standard is a head head efficacy study and so if we demonstrate known if your advocacy against approved vaccine in the population, which were starting at which in this case in vitro too is 50, plus adults, we do believe that could form the basis of and approve.
<unk> at the end of the day Immunogenicity results and in particular are only surrogates.
<unk> for efficacy and ultimately ask because he is is the gold standard that's what's required for traditional approval and that's why we're running the P. Through to study. So it will depend upon how conversations with regulators around that data package, but it is certainly plausible and in fact, one might say.
You know likely that if we meet efficacy in the efficacy study, but that would be sufficient to move forward for a full approval that doesn't mean that there may not be questions about demonstrating not inferior immunogenicity with influence be strange or other things and subsequent studies, but we do believe there's a possibility there but at the end of the day it will be dependent upon data.
And discussions with regulators, including the F D a.
And so we'll wait until we have that data and have those conversations, but I think it's certainly a possibility.
Now as it relates to age upon age for approval.
We're currently studying you're more than 10 10, only an older adults and so as I said the pizzeria one with an 18 plus feature choose and 50, plus and that's really where we see the broadest recommendations for seasonal influenza vaccine.
We have been most focused initially on building out our respiratory portfolio.
We will evaluate are important that vaccines in fact, many of our restaurant vaccines in younger populations over time, but we'll have to do H D escalation dose finding and then bridge down from enemies do mystery perspective, very much like what we did with Covid and so our initial filings for approval. If they proceed based on data would be in adults.
And older adults principally.
And then eventually we would follow on with a pediatric populations and as I said, a moment ago. In response to Michael's question that may involve using updated b antigens to increase immunogenicity in that population again, that's subsequent studies that we would do.
And children.
Could you remind me of the of the second question.
For RSV, what are you thinking for dosing frequency and how do you think about value and potential pricing of that vaccine maybe benchmarking after another vaccines for that age group.
What's wrong, so I'll, let all particularly the second part of that question first one frequency. It is not yet clear on how frequently people will need an artsy vaccine seasonal viruses seasonal epidemic of disease that shows up most of us have been exposed to RSV.
Well over a dozen times over the course of our lives and what really happens from biology perspective, as as we get older our ability to maintain high neutralizing titer to protect us goes down and what we have is breakthrough disease and ultimately a disease at least a substantial cost and morbidity and even some mortality in older adults we do.
Not we have not yet [noise].
[laughter] prove vaccines and so what would we don't yet know is what's the frequency of vaccination isn't gonna be seasonal every year or is it gonna be lessened seasonal every every couple a few years, but what's pretty clear based from my perspective based on the epidemiology of RSV infection is that we do see RSP fairly regularly as adults.
And unfortunately over time with breaks through more frequency and so there probably will need to be repeated boosting to protect against RSV.
At the end of the day. The initial recommendations will come from a C. I T.
You know as well as from regulators around that frequency.
And we will have to defer to them on how they want to.
And miserable out you'll receive vaccines, whether they want to follow a flu model, which would be annual to make sure that we get the broadest amount of protection or that they Wanna initially rollout RSV vaccines and then follow over time for the durability of that advocacy at this point none of US none of the three products that have right out in phase III have a clear answer on the durable.
City of that advocacy, although we would expect it to win.
Against natural RSP infection overtime and older adults.
But do you Wanna take the next part of the character.
Yep I can take my question on pricing. So overall from a pricing philosophy per second from Internet is committed to your pricing that reflects the value of our vaccines.
And in terms of what they deliver to patients to society and the health care system.
While also ensuring full access for patients regardless of their ability to pay so with that broader principle around on pricing.
We will be looking at a full recommendations that come out of a C. I P entry they kept the filing any except pay recommendations.
Can look at what day is full value that can be provided back is based on things to escape mentioned around dosing frequency.
And the pricing model based on both value and after that I'm not able to share any additional details on what sort of range that pricing might fall into but it will be consistent with our O'brien pricing philosophy.
Thank you one moment for our next question.
Our next question comes from Elie Moreau with you'd be extra line is open.
Mmm.
So much for taking my question just a moment.
Any more details I'm in higher level.
Or when will get more details on the pattern level and then constantly think about the importance.
Having tighter.
Or the benchmark versus demonstrating noninferiority like I guess lettuce.
Vaccine patterns.
Phase III get very well.
How should we think about the application.
Thank God.
Alrighty, what that might mean from a regular occurring standpoint as long as I can.
Commercial standpoint, and her bringing 19 S. A D.
[laughter], they're all very good questions and and I think the.
The short answer is we're looking into that data right now and we will provide an update I I'm not exactly sure. When we will have that but we do have the vaccine.
Investor meeting coming up in April with the spring and then obviously be looking to publish that data and share it as it as it comes in and isn't available.
The you you highlighted one of the key challenges inactive comparator studies and influenza in particular, which is that you can see high titers, but actually because you're looking at a ratio.
Save for whatever reason, you're active comparator does really well against one of the strains that can impact your ability to achieve noninferiority statistically.
And you know at the end of the day. The challenge is even more complicated you look at the older adults where for instance, the influenza be strange or not a big driver of efficacy or disease.
And so we will look at all of that asthma regulators I would note that it is well precedented in fact, many of the currently approved influenza vaccines have in the past missed on Noninferiority for in an influenza strain and point here or there and still have received full approval or accelerate approvals.
And the reason for that is as we've said sort of throughout that at the end of the day influenza B is not a primary driver of concern and it is known to be among the the different.
Different strains of influenza in the virus.
In the vaccines.
Of of lower import for disease in older. Adults in fact, one of the four strains there had been active debates about the the I'm a goddess trained as to whether or not it's gone extinct and even should be removed from quite a bit on the vaccines in.
In many of the recent <unk> W. H O in other debates and so.
Important to be is a you know well.
Well trodden path for many of these vaccines.
As well as now for I'm on a 10 10, where there is differential performance and ultimately there is there is precedent for moving forward, where you do not technically neat noninferiority on the news you missed yourself conversion and.
<unk> and still moving forward because of the lower concerned about that disease and older. Adults. So we will look at that data we will develop our strategy. We will obviously engage with regulators with that data and ultimately determined path for the most important thing for us, though in the near term.
Is continuing with the efficacy study trying to establish whether or not we have not inferior or even superior efficacy for him on I 10, 10 in its current form against influenza, a which is really where we think payers and public health officials will have the most attention because it is prevention of that disease not be immunogenicity endpoints prevention of him.
<unk> to like illness hospitalizations that is the primary objective of the vaccine and that's where we're we're focusing our attention right now.
Mmm, great. Thanks for the car.
[noise] one moment for our next question.
Our next question comes from Joseph Stringer with Native of your line is open.
Hi, good morning, Thanks for taking my questions to from US. The first one on 4157 Keytruda combo program. Just curious if you can give us a little bit more color and how we should think about the cadence of the additional trial starts is it something that will be more step wise and measured approach or should be used by sort of the full force and a multiple trials.
Approach and then secondly on rare disease outside of your M&A TSB NPA programs. What is the next emergency disease program that we can expect us to enter into the clinic. Thank you.
Oh, Thank you a lot of questions. So.
So in 41, 67, I think I'll, just read or apologize I don't want expand it to say that we are trying to move into those pivotal studies Europe phase III chromatoid size for melanoma, and non small cell lung cancer, both arguments settings.
This year and we.
You know you can look at the history of Merck and their ability to execute those studies enrolled quite quickly and now working together with us we hope to be able to at.
At least do that well and we will look to enroll those you know at least as quickly as as other confirmatory things through studies and similar populations have been run.
Generally, but I I I don't think we're gonna provide more specific guidance on a moment of time Harvey except to say, we're going to go as fast as possible I will also clarify to that from an accelerated approval perspective is that pathway were to become available based on the current phase two data, which again is subject to future conversations with regulators that we would want to.
Have started those confirmatory studies, we wouldn't have needed to complete enrollment, but definitely we wanna be demonstrating that we're moving forward and that's confirmatory studies as quickly as possible and so we have double impetus for moving fast and enrolling them in the near term now.
In the rare disease space programs moving out of.
Out of court preclinical and clinical the the first I would say, we do have a critical program for MMA, which you reference but that emanate program is another place where we expect to see additional data following on hopefully the continued strong performance of the appropriate on in Castlevania P. A program.
And then the preclinical development space.
We have programs again O T C and pizza you uhm, so if you're sitting area and a urea cycle disorder of D. C and those are both programs that we would hope to move into clinical testing in short order, we haven't specifically got it on the timing of that yet.
Great. Thanks for taking our questions.
Ladies and gentlemen says conclude the question and answer portion of today's call like turn the call back over this stuff off for any closing remarks.
Thank you very much everybody for joining girlfriends over menu for some questions. We look forward to hosting you for vaccine they don't they're pretty living it would be like in Boston for those or you can join US and also of course will be up shortly have a great day. Thank you.
Yeah.
Ladies and gentlemen does conclude today's presentation. You may now disconnect and have a wonderful day.
The conference will begin shortly to raise and lower you'll have <unk> you can dial 911.
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