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AGM 2018

May 9, 2018

Speaker 1

Welcome, everyone. Relations. And I'm going to hand it over quickly to our Chairman and support, John Martin.

Speaker 2

Thank you. Good morning. I'm John Martin, Chairman of the Board of Gilead Sciences. I'm pleased to welcome you to Gilead's 2018 annual meeting of stockholders. Before I call the meeting to order, I'd like to introduce to you some of the members of the Gilead team.

Sitting up front are members of the board of directors. John Cogan, Lead Independent Director, Jacqueline Barton, Kelly Kramer, Kevin Loftin, Richard Whitley, Gail Wilson. Perworld Olsen. Nicholas Moore, who's retiring us at this meeting. Thank you, Nick.

And of course, John Milligan, board member, President and Chief Executive Officer. We also have several members of our leadership team here this morning. Robin Washington, Executive Vice President And Chief Financial Officer John McHutchison, Chief Scientific Officer And Head of Research And Development. Greg Galton, Executive Vice President, International Operations And Corporate Affairs Katie Watson, Executive Vice President, Human Resource is Brett Fletcher, Executive Vice President And General Counsel. Sung Lee, Investor Relations and Amy Flood Public Affairs.

There are a number of other Gilead employees present and they'll be available for questions after today's formal agenda is complete. I'd also like to introduce Chris Nilette from Ernst And Young, our independent officers. The meeting will now come to order. Brett Fletcher will serve as secretary for this meeting We'll first cover the formal business of the meeting as described in our proxy statement. Afterwards, we'll make a brief presentation on the company's business activities and address questions.

The meeting will run-in accordance with the agenda and procedures, set forth in the rules of conduct given to USU entered the meeting. The board of directors has appointed Christina Vico, a Vico group tax as Inspector of Election at this meeting. Ms. Vico has taken and subscribed to customary oath of office to execute her duties with strict impartiality. We will file this oath with the records of the meeting.

Her function is to determine the qualifications of voters except their votes And when balancing on all matters is completed to tally the ballots cast to each matter. The sec will will the secretary please report on the stockholders list and the mailing of the meeting notice?

Speaker 3

I have a complete list of the stockholders of record of the company's common stock on March 16, 2018. The record date for this meeting I also have an affidavit from Broadridge certifying that on March 26, 2018, a notice of annual meeting of stockholders of the company was disseminated on the record date.

Speaker 2

Will the Secretary please report on the existence of a quorum?

Speaker 3

I have been informed by the Inspector of Election that proxies have been received or 1,117,000,003,6,821 shares of the 1,303,003,001,850,000 147 shares of common stock outstanding in the record date, which represents approximately 86% of the total number of outstanding shares This constitutes a quorum for the transaction of business.

Speaker 2

I hereby declare this meeting to be duly convened and the polls open for voting and the transaction of all business.

Speaker 3

Does anyone present wish to submit proxies, whether or not they have submitted proxies to both prior to now. Anyone need to vote at this meeting? If so, you can go back and talking as Vico back in the back corner.

Speaker 2

In order to expedite the flow of business at this meeting, we intend to adhere to the following quarter of this Each of the matters to be acted on by the shareholders today will be presented in the order set forth in the agenda. After presentation of all matters, I'll open the floor for questions or comments on the items of business. In order to ensure that the business of the meeting proceeds in an orderly fashion and that stockholders who wish to speak have a fair opportunity to do so, Questions or comments shall be limited to the items of business listed on the agenda. The actual vote on each item, however, will be deferred until all of the matters to be acted upon have been discussed.

Speaker 3

The first order of business is the election of 9 directors to serve with an for the next year and Intelli's successors are elected and qualified. The board nominees are John Cogan, Jacqueline Barton, Kelly Kramer, Kevin Loftin, John Martin, John Milligan, Richard Whitley, Gail Wilson, and Perry Will Wilson, each a current director of the company. Board of Directors has recommended a vote in favor of each of the nominees. The 2nd order of business is the ratification of the selection of Ernst And Young by the Audit Committee of the Board of Directors as the independent registered public accounting firm of Gilead for the fiscal year ending December 31, 2018, Board of Directors has recommended a vote in favor of this proposal. The 3rd item of business is the approval on an advisory basis of the compensation of our named executive officers as presented in the proxy statement, the Board of Directors has recommended a vote in favor of this proposal.

The 4th item of business is consideration of a stockholder proposal requesting that the board adopted policy that the Chairman of the Board of Directors be an independent director. The Board of Directors has recommended a vote against this proposal for the reason set forth in the proxy statement. Mr. Jing Zhao will present the proposal. Mr.

Zhao, please take the podium and as the proposal is described in the proxy statement and is being duly presented at this meeting, there's no need to read the proposal. And please limit your presentation to 5 minutes. Thank you.

Speaker 4

Proposal number 4 for independent board chairman. Shareholder requests our board of directors to adopt policy and amend our recovering documents necessary to require his force as the chair of the Board of Directors whenever possible be an independent member of the board. The board would have a discretion to face in his in this policy for the next CEO's financing implemented. So it does not warrant an existing agreement. If the board determines of the, a chair who are independent, when selected, is no longer independent, the board here select a new chair who satisfies the requirements of the policy within a reasonable amount of time Conference with this policy is waived.

If no investment director is available and willing to serve our chairman, This proposal requests that all the necessary steps be taken to accomplish they are about. Caterpillar is an example of a company recently changing course and naming an independent board chairman. Computer has strongly opposed the shareholder promoter for an independent board chairman recently, it's 2016 annual meeting. Wells Fargo will change the course and then an independent board chairman 2016. It was reported that that 53 of the ship of the sender and the force 1500 firms separate these two positions, 2000 and report.

This proposal topics from 5 50% plus support even as 5 major US companies in 2013, including 73% support at the Netflix This proposal talks about 44% support at our 2017 annual meeting. This 44% support could have been higher if support shareholders had the same access to corporate governance information as large shareholders. A number of institutional investors said that a strong objective chairman, Capes, provides a nursery oversight of management that the California public employees retirement systems global principles of accountable corporate governance recommend that the company's board should be chaired by an independent director and start the cancer counter of institutional investors and independent directors serving as chairman, can help ensure the functioning of an back to you for, please go to enhance the oversight of the CEO. Thank you very much.

Speaker 3

Thank you, Mr. Dow. The board's opposition statement for the stockholder proposal has been included in the proxy statement for all stockholders to consider. The 5th item of business is consideration of a stockholder proposal that the board takes steps to permit stockholder action by written consent. The board of directors has recommended a vote against this proposal for the recent set forth in the proxy statement.

Mr. Dawa present the proposal.

Speaker 4

Thank you again. And to the proposal number 5, right to activate writing content, Shareholders request that the board of directors take such steps as may be necessary to permit writing content by shareholders entire cast the minimum number of votes that would be necessary to authorize the acting, at a meeting, at which our shareholders entitled to both their own, where present and volume. This writing content is to be assistant with giving shareholders the fullest power to act by writing content consistent with applicable law. This includes shareholder's ability to initiate any appropriate topics for writing content, shareholder rights to act by writing content and to call a special meeting are 2 complimentary ways to bring an important matter to the attention of both management and the shareholders outside the annual meeting circle. This is important because there could be more than 1 year between other meetings.

A shareholder right by to act by writing consent is one method to equalize the restricted provisions our period of time for shareholders to call a special meeting. For instance, now takes 20 percent of DVR clients' shareholders to call a special meeting where many companies allow 10% of shareholders to do so. This proposal topic while majority shareholder support of certain major companies in a single year, includes 67% support at both our state and the Sprint last year The topic 1 majority vote at Western Union, rider system, and, both weather companies. This proposal topic was a 48% of support at 2017 Gilead Science annual meeting from 46% of support in 2016. Support could have been higher.

If small shareholder has access to the same corporate governance information as large shareholders, according to proxy insight, 200 and 67 fans voted in favor. 85 are post at the 3 of change, including Landguard. We believe more funds and individual shareholders were both for This year, giving our company's continued underperformance relative to the net debt countries of major companies and labor shareholders to act by writing content, including 64% of S and T 500 and the 55 percent of the S and T 150 include shareholder value, please vote for right to act by content. Thank you very much.

Speaker 2

The board's opposition statement for a stockholder proposal has been included in the proxy statement for all shareholders to consider. Does any any stockholder have a question or comment related to the any of the proposals If so, please proceed to the microphone located in the center of the aisle and wait to be recognized. Please identify yourself by name, organization, and ask a stockholder or proxy holder, then proceed with your question or comment. As a courtesy to other stockholders present, please limit your questions or remarks to 2 minutes. The secretary will now conduct the voting.

Speaker 3

I would now report on the voting of the stockholders at this meeting. Each share of common stock is entitled to one vote. The voting was conducted by proxy and written ballot. Having earlier requested stockholders intending to vote at this meeting to register their votes with Ms. V.co at the back of the room, the polls are now closed.

The preliminary report of the Inspector of Election is as follows: The Director nominees have been elected with between 97% 99% of the shares voting in favor of each director. The selection of Ernst And Young by the Audit Committee of the Board of Directors as the independent registered public accounting of Gilead for the fiscal year ending December 31, 2018 is ratified, but approximately 97% of the shares voting in favor. The advisory vote to approve the compensation of our named executive officers as presented in the proxy statement is approved with approximately 89% of the shares voting in favor. The shareholder proposal requesting the board adopt a policy that the chairman of the board of directors being independent director was not approved. Approximately 45% of the shares voting in favor.

The stockholder proposal requesting the board to take steps to permit stockholder action by written consent was approved with approximately 51 percent of the shares voting in favor. The final results of the voting will be reported in the Form 8 K within 4 business days from today.

Speaker 2

This concludes the formal portion of our meeting. After adjourned, John Milligan, President and Chief Executive Officer will provide a presentation on Gilead and then we'll entertain relevant questions from stockholders.

Speaker 1

Good morning and welcome everybody. It's my pleasure to be able to present on Gilead Sciences and on behalf of the Board of Directors. A presentation on Gilead. I hope this will give you some idea of where the company is and where we have high expectations about where the company will be going in the future. Then we'll have question and answer at the end.

So here we go. That's me. I just want to say we will be making forward looking statements during the course of this presentation. There are many risks associated with our business. I advise each of you to read our most recently filed 10 Q for more information on those risks and our upcoming filing of our sorry, we're speaking about 10 K and our upcoming 10 Q for more information on those risks.

I think today, we can say that Gilead has had exceptional performance. We are the scientific leader in HIV, where we have brought forward the most innovative products and treat the most number of patients. About that through the courses presentation and the work we've done in HCV and now in diseases like NASH. And we've now become the leader in cell therapy through last year's acquisition Kite Therapeutics along with other technologies that we've brought forth to really push forward the most innovative and interesting technology that is now countries where we have direct representation and of course work through many, many partners globally to bring access to the remainder of the world. We treated about 1,700,000 people with HCV, the vast majority of whom have been cured by these very short term, very powerful medicines.

In terms of HIV, we continue to broaden our global presence through our partnerships with the Indian generics and with our work especially in the developing parts of the world in Sub Saharan Africa, Southeast Asia, Central And South America, where we now estimate that over 11,500,000 people have access to Gilead's, one of Gilead's H. W. Medications and take them every single day. Which is an amazing growth over the last 15 years when we started this program when fewer than 30,000 people were being treated in this part of the world. And we're positioned for growth.

We ended the year in the quarter with a very strong balance sheet with over $32,000,000,000 on our balance sheet which is well positioning us for future M and A and partnerships as we continue to broaden the categories that we'll participate in trying to reach more patients with unmet medical needs globally. 2017 was a very transformative year that we started at JP Morgan Conference earlier this year, you can see the amazing growth that has occurred between 20122017. What's left out in the middle years is the massive growth that occurred from HCV. That category is now winding down. And you can see as we go into 2018, we expect revenue to be down further.

All is a result of declining revenues associated with HCV, whereas our underlying business in HIV continues to grow very dramatically and very consistently and will be a future driver of growth, which makes this really a transformative year as we break out from the declines of HCD back into a growth phase with smaller HTV revenues, but increasing revenues associated with HIV and our future products. Over the last decade, we've had tremendous I'm sorry, over the last 5 years, we've had tremendous operational excellence with over 13 U. S. NDAs filed We have 4 of the top 10 pharmaceutical product launches of all history. We have 1, 2, 3 and number 9.

That is amazing of feet over those years. We have industry leading margins at greater than 50%. And as I mentioned in the balance sheet, we have strong cash flow to support the company. 6% of our free cash flow have been returned to shareholders. We initiated a dividend program, which we have had 3 subsequent increases in the dividend rate.

And we have reduced the share count by 14% through judicious use of stock buyback programs. Looking forward over the next 5 years, what do we see? Well, number 1, we see continued innovation and growth in HIV as our new TAP based product and new innovative products that I'll talk about in a moment come to market. We have new products for the treatment of liver disease and inflammatory diseases, a new category for us. And these are products that are moving through the pipeline I'll speak about in a moment.

As I mentioned in my first slide, we become a leader in cell therapy and continue intend to continue to build off that leadership. And we will have continued operational excellence trying to get the most out of our people and our processes for the benefit of patients. And shareholders alike. So HIV, as I mentioned, I think this is a growth story for If you think about 2000 and 1 through 2014, this was all about TDF. That's tenofovir Dysaproxal fumarate for the chemists in the audience.

It is the active ingredient. It has been one of the components of almost all our combination of almost all our HIV drugs, including all our combination movements. That led to such breakthrough product as a triplet, the first single tablet regimen and Complya and Stryville to other STRs that we've brought to market which were hugely beneficial to patients. Beginning in 2000 and 5, we began to launch TAF based products. TAFEVER alafenamide It allows low dose, a lower dose to be given to patients with the correct exposure.

This was a very difficult molecule size and scale up. It has proven to be highly effective and safer in clinical studies than in our comparison with both TDF containing regimens and other regimens. So we have a product that has a very important attribute for patients. This product has now Tarvey is a single tablet regimen containing TAF, m trisitabine also known as FTC. And then importantly, Bictegabir, which is This is the first product with our new product, Bactagavir, which is a integrase inhibitor that does not require boosting as a low dose.

And so biktarvy as an STR is the smallest pill that you can take as a single tablet regimen once daily for the of HIV. So this is a very important product, and we're very pleased with both the way the labeling has gone, the outcome of the many clinical studies that we've run, and its uptake to date. We think that innovation in HIV is not over. We're thinking about what the future might needs might be for HIV in patients including things like long acting injectables. Now with a single tablet regimen, you might think what's better than and simpler than taking one pill once a day.

But for many patients, especially patients who lead chaotic lives, they are unable to stay on regimens, even with the simplicity of a single tablet regimen. And we note that while there's a high level of treatment rates in most of the developed world, there's still a large number of people larger than there should be who don't seek therapy. And perhaps long acting injectables could be an answer for them. And we're looking at injectables that could be given once monthly, perhaps as infrequently as once every 3 months, that could serve as a way to get these patients the medicine they need, bring their virus under control, and then importantly prevent those people from spreading the virus because in many studies, we now know that treatment prevents the virus from being transmitted to other people and can stop the spread of HIV in the United States and throughout world. So we're very excited about this, and I apologize.

This is the only chemical structure I'm going to show you today. This very, very complicated molecule is something called capsid inhibitor. This is a molecule that has now gone into the clinic. It has the potential to be a very low volume injection that's important because the small volume doesn't hurt very much, is easy for a physician to administer and has the potential at least based on animal studies to be given very infrequently. It is a new category of product.

There are no capsid inhibitors currently marketed for the treatment of HIV, which means it has great flexibility in being used in patients who may have already become resistant to other patients or perhaps can be used in patients as upfront therapy or perhaps as prevention. If you can imagine the complexity of a life of somebody with HIV, the ability to infrequently inject for prevention of HIV could be substitute for vaccine and keep, again, the infection rate from spreading further than it does. We're also working on molecules for treatment resistant HIV Aptid inhibitor could be one of those. We've also entered in the clinic with a program. I'll just call GS-nine thousand one hundred and thirty one.

It is another nucleotide inhibitor versus transcriptase like TDF and TAF, but with very different characteristics, and we're now exploring its use in highly treatment resistant patient And of course, we've embarked upon a program to try to see if we can eradicate the disease through different kinds of modalities We also put grants out. We issued $20,000,000 in grants to various academic institutions over the last year, seeking new ideas and how to potentially eradicate the disease patients. In terms of thinking about TAF, we talk about Descovy based regimens, Descovy is TAF plus amtricitabine This is a product that is 2 of the 3 components. We call it the backbone of therapy because then you add a third agent such as a bactagavir on that to make the regimen that you need. So in terms of all Descovy containing regimens and they're listed down to the lower right hand side here by their trade names, We now find that whereas TDF base or Truvada based, EF base or Truvada based regimens had been the predominant of form of use in the United States.

We now see that 65% of patients have switched to 1 of the several Descovy option based options that are available. And that continues to grow very strongly. So we're very pleased with how Descovy has been used. If we think about the future world We think it's likely that discovery will be the principal backbone in all patients who treat the majority of patients who are treated for HIV, the vast majority. Outside the United States, we also see very positive signs for the uptake of Descovy based regimens in the larger European countries First time's sake, I'm just gonna highlight 2 here in France.

We see that Gen Voya, which launched couple of years ago, just over a year ago, I should say, in France, but was approved a couple of years ago in Europe has now become the number one regimen for the treatment of HIV in France. In Italy, we see Descovy itself has done extremely well, but you notice that Odepsi and Gen Boya, 2 other TAF based regimens are closely catching up with Descovy and very, very popular in Italy. So this just shows and highlights the importance of Descovy based regimens and TAF based regimens globally. In terms of biktarvy, it was just recently approved in the United States. So in February of this year, we had approval.

So it's just come to market. We anticipate in the EU will be approved in the third quarter of this year. We just had a positive CHMP opinion. It takes about 2 months from that opinion to get full easy approval, which allows us to then start to sell and negotiate prices in the European countries. We're very pleased that the USDA HHS guidelines were recently updated to include Viktarvy as an initial a recommended initial regimen for the treatment of HIV based on its benefits as in our FDA prescribing information.

And we do, again, as I said, we think this will become the number one regimen for the treatment HIV for both treatment naive. So patients new to therapy and patients who are switching other other off other regimens. We had about 6 weeks of sales in

Speaker 4

I want

Speaker 1

to talk a little bit about prep prep is pre exposure prophylaxis. So this is the ability of a person who doesn't have HIV to take a pill to try to prevent the acquisition of HIV. And this is particularly important who are and patients who are people, excuse me, not patients, but people who are at high risk of acquiring HIV. Preps should be used in combination with other protective measures such as condom use. We have found in clinical studies that the addition of Truvada this is does lower the risk of becoming HIV positive.

And this is growing in popularity in the United States and we saw at the end of the last quarter. We had about 167,000 people in the United States were using prep as part of their ways to prevent the acquisition of HIV. It's the only therapeutic that's approved for the treatment of preventing HIV It's interesting we're seeing that people take their medicines fairly regularly. It's almost on par with what you would do if you were taking HIV medications. So There is a consistency to take in the medication, which is good because if you don't take your medicine for prep, you're not protected.

It's not like a vaccine. You have to take it, when you're at risk. We're also very interested in seeing if a Descovy based regimen can also be used in prep. We're pleased to say that Descovy for Prep those aisles fully enrolled far ahead of schedule. We are running a head to head study looking at Descovy versus a Truvada based regimen to look at the benefits of Descovy and that is running ahead of schedule.

Okay. I'm going to turn my attention to liver diseases now and turn first to HCV. So As I mentioned, we've had a very complete portfolio of HCV products. It's been a very interesting adventure of serial innovation. It's very unusual for a company to invent and then replace its medicines as quickly as we have in HCV.

We brought Civaldi to market in 2013. 2014, Savaldi was one of the most was one of the best selling medicines in the United States. And of course, at the end of that year, we made it essentially obsolete by, bringing Harvoni to market, for the treatment of HCV. And then subsequently, 2 years after that brought ebbs into market for the treatment of HIV. So whereas Cevaldi was one of the best selling drugs in America in 20 in 2014.

In the first quarter of this year, its sales were negligible. So we have made it essentially obsolete by bringing newer, better medicines to market. We also recently brought BoseVI to market. BoseVI is a product that contains 3 drugs and is very useful for patients who may have become resistant or failed other therapies. Across Gilead's portfolio, we have different options of 8 weeks, 12 weeks, and options for treatment resistant patients that provide all the needs in high potential cure rates for nearly every patient out there.

So it's a very comprehensive portfolio. Well, as we mentioned earlier, we are seeing a lower yet more predictable amount of sales. Prices have come down very dramatically over the course of the years as new competition has come to market. The prices that are represented by the price, right? So probably 4 to 5 times higher than what actually a patient would have to pay or a system would have to pay.

So prices have come down dramatically. We've also seen fewer and fewer patients as you cure patients, new ones have to come into the doctor to be diagnosed and treated And so that market is becoming smaller, yet I think more stable and predictable and frankly a smaller part of our portfolio going forward. So we do see it's a more stable market dynamic going forward, which means the growth of our underlying business can shine through and not be overshadowed by HTV. I mentioned in my earlier slide, we're moving on to new targets. So we'll talk about NASH.

NASH is the disease called non alcoholic steatohepatitis. So this is a severe form of fatty liver disease. Fatty liver diseases in general are a growing problem Across the globe. There may be as many as 15,000,000 people in America who have some form of NASH or fatty liver disease and it is growing in prevalence. As a result of diet and lifestyle principally.

NASH is a result of something called hepatocyte lipotoxicity. So what does that mean? It means you have fat building up in cells that cell has untoward effects including killing off hepatocytes. That can lead to inflammation. That inflammation can lead to fibrosis which can be very difficult on the architecture of the liver and cause decreased liver function over time.

And it's a cycle that goes on getting worse and worse and worse. So patient, for example, which would have the most severe form of NASH, something called F4 NASH, F4 describes the state of fibrosis as being the worst those patients typically have a median life span of about 5 years. NASH has become the number one reason for liver displantation in the United States, replacing HCB and HBV as the cause as we have great therapies and cures for those diseases. So this is a growing importance and one that we have tackled with a number of products. We're going after hepatocyte lipotoxicity with 2 products one's called an ACC inhibitor.

This is a direct actor on the fatty acid production. We call GS-0976 And the other is a little bit of an indirect actor on fatty acid synthesis called an FXR agonist or GS9674. The most advanced program we have is really on that boundary of inflammatory disease in fibrosis. It does act on an inflammatory component. It also seems to act on the for broader component of NASH.

And that's our ASK-one inhibitor, which has now been given the generic name Soloncertib. And it's targets something that's upregulated in something called oxidative stress. So when you're in an inflamed state, you're in oxidative stress. This targets some of the signaling. It helps relieve the cell from that causing a reduction in fibrosis in clinical studies so far.

So, selonsertib is 1st in class molecule It's very active. So we can see that the targeted enzyme is very active in liver biopsies of patients with NASH and it correlates well with the fibrotic state of the patient. We had very positive data. You can see on the lower right hand side showing that fewer patients got worse. More patients got better.

To simplify this graph with increasing amounts of our ASK-one inhibitor. That led us to embark upon 2 big phase 3 studies. We call them the STELLAR studies, STELLAR3, which is an F3 patients with fibrosis and STELLAR4, which is an F4 patients with fibrosis. Those studies fully enrolled ahead of schedule, which means with the 48 week endpoint of these 2 studies, we will begin to have datasets available around the end of the year, probably announced next year into early next year. If these two studies are positive, as be predicted from the phase 2 studies.

This would allow us to file for approval and perhaps one of the first drugs to file for approval for NASH around the end of next year. So this is a very exciting program in a brand new product category where there currently aren't any treatments for disease and we could have some of the first products available. As we have with HIV and with HCV, we're satisfied with a single product and we are embarking upon combination studies of our Esco inhibitor along with several other agents. Excuse me. This looks at our Phase IIb studies of NASH.

We announced some of our 2A results at a meeting called the International Liver Conference, often known as EASL. Those data were designed to test the safety of various combinations Each of those programs is deemed to be safe enough to go into larger studies. And we did see some really interesting activity in combining 2 mechanisms. Those were studies of only 12 week duration, which is perhaps a little too short to see the real benefit of a product or combination product And as you can see here, we're embarking upon a comprehensive 350 patient study looking at various dual combinations of our products as compared with the monotherapies as compared with Placebo. So with about 70 patients in each of these arms, we should have a pretty good idea of which combination would be the best to move forward into further studies of NASH, trying to do better, more good in this field than we might be able to a looser to the loan.

So we will be pursuing this, kind of started the, started to run these studies. So I'll turn to inflammation. I mentioned this earlier in my study. We are studying a molecule called Filgotinib, This is something called the JAK1 inhibitor. It's very selective.

The JAK pathway has been known to be involved in a lot of autoimmune and inflammatory disorders. We liked the preclinical profile of this program. It became available for licensure after our partner Galapagos, which is a European company, had acquired a fairly extensive human clinical data set of about 900 patients where we felt that the safety and benefit of this program had the potential to be best in class. We have a lot of work to do to prove that, but we're very pleased with the selectivity of this versus JAK1 We like what we've seen in a lot of the preclinical models in terms of the potential toxicity. And we are now running very large studies to look at how this program could be for diseases such as rheumatoid arthritis inflammatory bowel disease, ulcerative colitis Crohn's disease.

We are currently running 3 big FINCH studies. I'll show you on the next slide. These studies, have fully enrolled with data anticipated by the end of this year. So we will, in the second half of this year, start to have data sets that show in large, well controlled, randomized, and I often active controlled studies, what this product looks like. We're also doing proof of concept studies in 5 additional disease areas that I'll show you in a little bit.

To date, we've collected about 1700 patient years of treatment experience in various studies. We do think the responses are quite durable and the safety profile is consistent with all the reported studies that we've had to date. So this just looks at the overall filgotinib clinical research program As you can see, there are 5 pivotal Phase 3 in rheumatoid arthritis as I described earlier. We have another one in ulcerative colitis will enroll 1300 patients. So that is ongoing and enrolling.

And one in Crohn's disease, that's what CD stands for. They're looking at both people who have experienced failure after going on a biologic that is used to generally something called the TNF alpha inhibitor and also patients who are naive to therapy. We're looking at other inflammatory diseases. Some of these will start to play out during the course of this year and next year. These are phase 2 studies to see if we have activity at the highest dose of filgotinib and things like psoriatic arthritis, ankylosing spondylitis, lupus, sjogren syndrome and uveitis.

So these products tend to have fairly broad activity and we will continue to explore a range of activity for both safety and efficacy as we continue this program. One thing that I learned about autoimmune and inflammatory diseases is how difficult it has been to study and how the tools over the years have been fairly inadequate at really figuring out why patients respond or they don't respond to certain therapies and importantly, why patients fail certain therapies. So the science is unbelievably complicated. We formed a recent partnership Verily because Verily had come up with something called their immunoscape platform. This is a really sophisticated way to interrogate the human immune in a way that was somewhat unimaginable because of the complexity of what they're doing and the data analysis that's required for each patient.

So they're able to segment a human, white blood cells into 24 different categories in Carrogate gene expression across 1300 genes. And then aggregate those data for each single patient. That is a terabyte of data for patients. And only companies like Verily which is part of the alphabet world has access to the kind of data crunching capability to be able to do that. They have now established a baseline for what people without disease look like.

And we are working with them to look at our various clinical samples to ask the questions, what do patients respond look like what changes in their immune system or not for patients who don't respond. What does that look like for patients who respond and then fail? What does that look like. And so we will have one of the most sophisticated data sets for really understanding what happens at the cellular level when a patient fails or responds to therapy. Think this could be useful in identifying the correct patients for coming on to therapy.

We think it could be useful for identifying which next therapy might be best for a patient. And we think it might unleash new targets that we could go after to really do what hasn't been done, which is push the boundaries even higher in rheumatoid arthritis to give more patients better remission for longer periods of time. So we're I'm clearly very excited about this. This is really if you're a geek like I am in technology, this is the bringing together high-tech biology and science in a way that was unimaginable 10 years ago. So we're very excited about this collaboration.

And then finally in oncology, let's talk about the cell therapy revolution. So this is another technology. The number of inventions and discoveries that had to come together to make possible is just unimaginable. And yet we figured out the immune system. We figured out gene engineering.

We figured out how to insert genes. We figured out how to grow up cells. Deliver them back to patients in a safe way that makes this kind of thing now possible to do on a commercial scale. So Yescarta is the 1st The second approved first for adults with diffuse large B cell lymphoma is another aggressive B cell malignancy to use a patient's own cells, genetically engineered, then put them back into the patient to fight their cancer. And they're having some really strong effects in these patients.

In Europe, this this should be the first approved product for the treatment first approved cellular therapy for the treatment of B cell lymphomas, and I think is really setting the bar for what we can do to cure cancer. In the United States, we have 40 cancer centers already authorized. This is a difficult process of training doctors, administrators, all the various people who care for patients. A very complicated process and it is a program that is difficult to administer and has some severe side effects. So we want to be very careful about how we administer this.

We're expanding our centers. And we think we'll have enough centers up and running. So about 80% of patients in America are covered by the mid year. And we'll cover the vast majority of geographies where those patients come from. I can say that this is a complicated product, new complicated products and hospitals come some reimbursement, and, challenges as it takes a while for places like CMMC, like the Center for Medicaid and Medicare services, to come up with the drug reimbursement codes necessary so that they can get the hospitals can get reimbursed for this.

We are working to that. And it's been going fairly consistent with our expectations leading to about $40,000,000 in net product revenues in the first quarter. There's a meeting called the ASH or the American Society Hematology meeting. This was in Atlanta in 2017. So this takes place in December every year.

These are just a couple of the cool headlines that came out from various articles. CAR T really took center stage at ASH There were over 300 different abstracts from various institutions on what they're doing with CAR Ts as people have really started to understand that cancer mission for a long period of time. So many good headlines about Kite and Gilead and the results that were presented there. Gilead and Kite had 97 different abstracts at ASH. So it was a really important meeting for us.

These are some of the data that came out at ASH. There was a concurrent New England Journal of Medicine that's NEGM up there publication that came out This is an updated updated data set to the data that went in for our U. S. Label. You can see that we now have longer follow-up on more patients, almost twice as long a follow-up.

In our extended group, we have an objective response rate. So a response in patients of over 80% to 80 percent. That's pretty remarkable. These are patients who have failed generally 4 different kinds of therapy before they come on to our therapy. And are in very, very bad shape.

So to have that kind of response rate is remarkable. At some point, there was a complete remission rate in 58% of patients The median duration of response has not been reached and the median survival has not been reached because the patients are still doing well. So that is really remarkable. As I mentioned, this does come with some side effects, which are considerable, including something called CRS that is a cytokine release syndrome associated with cells expanding and attacking your cancer And there are neurological toxicities generally in amnesia that occurs in patients that typically resolves with very little ongoing issues for those patients. One thing that we're proud of is that we enrolled patients, we were able to deliver were able to successfully manufacture for 99% of the patient to enrolled and 91% of the patient to enrolled were able to receive their CAR T.

I will say that some of the patients are so sick that by the time you get the cells out, manufacture them back and that takes about 17 days. Some of these patients did were not able to make it to the final infusion because their disease was so difficult and they were so late stage, which is unfortunate. I've highlighted those things in the red box already. I just wanted to show you one cool slide. This is a Kaplan Meier Curve showing overall survival And you can see that there are the long tail small numbers of patients, but there's a very long tail showing that patients who do respond and have a good response to CAR T, that that can be a very durable response.

Again, this is a single infusion of cells. So a single treatment that can persist for a very long period of time. And we're studying the persistence. Those cells can stay in your body and continue to fight cancer Some of the early studies done at the NCI, especially in pediatric patients, have many patients have evidence of the CAR T cancer fighting cells well beyond a decade. So this is now something that can fight the disease in your body for a long period of time.

And compared to historical controls, there's a 72% risk reduction reduction in the risk of death compared to controls on that astounding for such a late stage disease. We're not going to be satisfied with just these patients we think that this could be a benefit for more patients and more categories and could be a huge benefit to patients and the system by going to earlier lines of therapy. Instead of waiting for multiple lines point to Zuma-five, sorry, Zuma-seven at the bottom, that is 2nd line therapy. So we are comparing CAR T therapy to the current 2nd line standard of care, which is a bone marrow transplant. So we think there's an opportunity to perhaps have a better outcome for with a CAR T therapy versus a bone marrow transplantation.

We're exploring that in that clinical study of 350 patients. We're looking to expand our indications into different areas. So we have this as KTC19. This is our CD19 therapy with different manufacturing conditions, looking at mantle cell lymphoma and adult pediatric adult lymphocytic leukemia. We're also expanding the number of tumors we're looking at, including multiple myeloma through our KTE-five eighty five that target something BCMA and known myeloma target.

And we're starting working solid tumors with something called MAGE A386 looking at various solid tumors that expresses including non cell small lung cancer, not small cell lung cancer, melanoma and other cancers which are known to express this antigen. So this is the first indication, which a CAR T is being used against a solid tumor, not a hematological tumor such as a lymphoma. So what's next? This manufacturing process is complicated and expensive. So we're trying to increase the efficiency of our manufacturing.

We're trying to come up with cellular therapies that are safer and have greater efficacy in these patients. We're exploring different ways to do that. And we're looking at allogeneic cell therapy. So what is allogeneic cell therapy? Well, currently today we do something called autologous That means we take your cells, we modify them, grow them back up and put them back into you.

So your body won't reject them because they're your own cells. Allogeneic is when a male transplant comes from one donor to the next. So there are risks of rejection and something called graft versus host disease. We're trying to figure out if we can't come up with a way to have healthy volunteers donate their cells, engineer out the components that would cause graft versus host disease or rejection, put them back into patients and have more of an off the shelf product. There'd be greater manufacturing efficiency.

So it could be done much more cheaply. We can deliver it to patients much more quickly. So those patients who are severely ill would have a chance to get CAR T before it's too late. And so this could be a really important manufacturing process. Improvement for patients.

We're accelerating this work through an acquisition and a collaboration. The acquisition with cell design labs that gives us some optionality on how to control cells. For example, we can now design CAR Ts that have to target 2 different things before they would attack that cell. We also have a way to turn a switch on or off to turn off the CAR T cell in case of untoward side effects. We also did collaboration with Sangamo.

Sangamo was one of the first gene editing companies. It has a different kind of technology, but it's analogous to what you might have heard about with CRISPR Cas9. It's the ability to vary a efficiently and effectively target certain genes either to knock them out or to introduce new gene sequences that could be useful and we're collaborating with them. Trying to come up with ways to come up with an allogeneic strategy for not only CD19, but for a variety of different cancers and we have 10 different product categories we're looking at with Sangamo. So we're continuing to bring a technology that will help us in CAR T.

So finally, just some closing thoughts on Gilead and then I have a couple of other slides. We're positioned as a leader across our core therapeutic areas with the current product and our emerging products. We have the financial strength to continue to build our pipeline, both internally, also through acquisitions and through partnerships, which we've shown that we will do. We continue to have a science focused culture that fosters waves of innovation last night's board dinner with all about continued innovation into the future. And we have a continued focus on operational excellence and try to remain as lean a company as we can to do the things that we want to do for patients.

We take our corporate social responsibility very seriously. This is the cover of our 2017 year end review. I urge you to go to our website to read it. It is a nice collection of the data and the stories about the work that we do around the globe, including the $400,000,000 we donated in 2017 to more than 20 sorry, 2000 non profit organizations. We launched a pledge.

It's called our Compass program, which is redirecting and more specifically targeting the American south of the HIV epidemic is growing at an alarmingly high rate. We continue push our medicines into low income companies, not only our TAF based regimens, but now our TAF based regimens and our HV regimens targeting 130 low income country across the globe. We've been supporting worldwide efforts to try to eliminate HCV. We had a really nice map at our booth at the International Conference On Liver Diseases. Showing eradication programs around the globe and the effect they're having in some of our demonstration projects such as Iceland program and the Republic of Georgia, our program in Pakistan Egypt where the diseases have the highest prevalence and are hitting those societies the hardest.

And so we also in 2017, more than 40,000 people are received, sustainability programs. It's 2 numerous to go in here. I urge you to read our 62 page report on all the different things that we're doing across sustainability, across employing engagement across diversity and importantly all the things we do for patients globally. So I was just going to finish up with a picture of 2 of our workers at our El Segundo, California facility. If you wonder what it looks like to manufacture CAR Ts, it's a lot of tanks of liquid nitrogen where we store cells.

It's a lot of hoods where technicians and quality control people are very carefully

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