EX-99.2 3 dp136489_ex9902.htm EXHIBIT 99.2

 

Exhibit 99.2

 

 

 

Page 1

 

1

 

2

 

3

 

4

 

5

 

6

 

7

 

8**************************************

 

9AUDIO TRANSCRIPTION OF

 

10GILEAD SCIENCES

 

11CONFERENCE CALL

 

12GILEAD TO ACQUIRE IMMUNOMEDICS

 

13SEPTEMBER 13, 2020

 

14**************************************

 

15

 

16

 

17

 

18

 

19

 

20

 

21

 

22

 

23

 

24

 

25

 

 

 

 

 

 

Page 2

 

1MALE SPEAKER: Ladies and gentlemen, thank

 

2you for standing by and welcome to the Gilead Sciences

 

3conference call. At this time all participants are on

 

4the listen only mode. After the speaker presentation

 

5there will be a question-and-answer session. To ask a

 

6question during the session, you would need to press

 

7star 1 on your telephone. Please be advised that

 

8today's conference is being recorded. If you require

 

9any further assistance, please press star 0. I would

 

10now like to hand the conference over to your speaker

 

11today to Douglas Maffei, Senior Director Investor

 

12Relations. Thank you, please go ahead.

 

13MR. MAFFEI: Thank you Dalim (phonetic).

 

14We appreciate everyone joining us on short notice for

 

15today's call to discuss the exciting acquisition of

 

16Immunomedics announced earlier today. The speakers on

 

17today's call will be Daniel O'Day, Chairman and Chief

 

18Executive Officer; Merdad Parsey, Chief Medical Officer;

 

19Johanna Mercier, Chief Commercial Officer, and Andrew

 

20Dickinson, Chief Financial Officer.

 

21Before we begin, let me remind you that we

 

22will be making forward-looking statements that are

 

23subject to risks, uncertainties and other factors that

 

24could cause actual results to differ materially from

 

25those referred to in any forward-looking statements.

 

 

 

 

 

 

1These risks and uncertainties are contained within our

 

Page 3

 

 

2joint press release, presentation and latest SEC filings

 

3of each company. I will now turn the call over to Dan.

 

4MR. O'DAY: Thank you, Doug, very much and

 

5good afternoon everyone. Really, thank you for joining

 

6the call, especially on a Sunday. We are -- I speak on

 

7behalf of the entire leadership team, we are very

 

8excited to share this news with you today. It really is

 

9a transformational acquisition that gives us tremendous

 

10potential to help patients with cancer and generate

 

11significant value.

 

12So on today's call we wanted to articulate

 

13the why behind the acquisition for Gilead and provide,

 

14obviously, the opportunity for any questions that you

 

15may have. So I'll start out and then I'll pass the

 

16baton over to Merdad to talk about the potential of

 

17Trodelvy. Johanna will then offer some insight from a

 

18commercial perspective. And then, finally, Andy will

 

19speak to the structure and the financial terms of the

 

20transaction.

 

21So as all of you know, we set a strategic

 

22ambition at the start of this year to deliver more than

 

2310 transformative medicines and therapies to patients in

 

24areas of high unmet medical needs. And as part of those

 

25efforts we've been building a robust and diverse

 

 

 

 

 

Page 4

 

1oncology portfolio. In fact, we'd already completed 12

 

2key deals in oncology in the last two years including

 

3the acquisition of Forty Seven.

 

4Now, upon closing our acquisition of

 

5Immunomedics, we are fastforwarding our plan to build a

 

6substantial oncology business with significant

 

7potential. I mean, really, the shape of the portfolio

 

8changes really significantly with this acquisition.

 

9Trodelvy has tremendous potential and we

 

10saw some of that in the standout data for triple-

 

11negative breast cancer that led to the accelerated

 

12approval. This medicine is highly innovative. It's an

 

13antibody drug conjugate that has shown really

 

14demonstrable efficacy in the area of very high unmet

 

15medical needs.

 

16In particular, the top line results that

 

17Immunomedics shared in July from its phase 3-ASCENT

 

18study provided significant evidence of clinical benefits

 

19and confirmed findings from previous studies around the

 

20safety and efficacy of Trodelvy. Trodelvy met the

 

21primary endpoint of progression of pre-survival.

 

22Trodelvy also met the key secondary endpoints including

 

23most notably, overall survival as well as objective

 

24response rate. But also highlight that we have reviewed

 

25significantly more clinical data on the product over the

 

 

 

 

 

 

Page 5

 

1past several months that gives us greater confidence in

 

2the clinical benefit Trodelvy can provide. Some of that

 

3data you'll be seeing at the upcoming ESMO conference

 

4this coming weekend, and I know that Immunomedics looks

 

5forward to sharing that with you.

 

6On the commercial side, although the launch

 

7is still early, the response from physicians and

 

8patients has been very encouraging in triple-negative

 

9breast cancer. We expect increased uptake among this

 

10group of patients who are in dire need of new treatment

 

11options. While it is already begun to play an important

 

12role in triple-negative breast cancer today, we also

 

13recognize the promise that Trodelvy potentially offers

 

14for many other groups of patients.

 

15We'll work with Immunomedics to continue to

 

16explore its potential in earlier lines of therapy and in

 

17other solid tumors, both as a monotherapy and in

 

18combination. I mean, it's really a pipeline in a

 

19product when we think about this from an oncology

 

20perspective. If we look at Trodelvy in the context of

 

21our overall oncology portfolio after closing the

 

22transaction, we'll be adding a transformative

 

23cornerstone therapy that gives us an immediate presence

 

24in solid tumors. We are gaining the considerable

 

25talented expertise that Immunomedics has in this field

 

 

 

 

 

Page 6

 

1and a first-in-class marketed product. This accelerates

 

2our expansion into solid tumors and builds on our

 

3existing strengths in hematologic cancers to our

 

4combined Kite and Gilead pipeline.

 

5From a financial perspective, following the

 

6closing of the transaction, Trodelvy will immediately

 

7contribute revenue and will significantly enhance our

 

8growth prospects in the near term and longer term. We

 

9expect the acquisition to create significant value for

 

10our shareholders. The transaction reflects the

 

11potential value as well as its synergy that it brings to

 

12our existing platform and our future pipeline.

 

13And finally, let me say that we're looking

 

14forward to welcoming the team from Immunomedics to the

 

15Gilead Family. The kind of achievements that they have

 

16made with Trodelvy are only possible when you have

 

17really talented individuals in place with strong

 

18expertise and commitment. We feel very fortunate that

 

19we'll have the opportunity to benefit from their talent

 

20and expertise at Gilead as we continue to build a strong

 

21presence in oncology and work to make a positive impact

 

22on the treatment of cancer.

 

23Finally, I want to thank all the talented

 

24Gilead and Kite teams for their critical work on

 

25advancing our pipeline of medicine in oncology and in

 

 

 

 

 

 

1virology and inflammation. I'm proud of our momentum,

 

Page 7

 

 

2proud to be a part of the team, which I now look forward

 

3to building on with today's acquisition.

 

4So with that, let me turn the call over to

 

5Merdad. Over to you, Merdad.

 

6DR. PARSEY: Thanks Dan. And I want to

 

7start by saying that I'm also -- it's been very

 

8impressive to see the growing body of data both

 

9scientifically and clinically supporting the use of

 

10Trodelvy. You know, the phase 3 data from ASCENT really

 

11reinforced the premise of Trodelvy's unique ADC

 

12technology and validates the promise of the TROP-2

 

13targeting therapy. Clearly, this groundbreaking

 

14medicine, and in particular, in an area of high unmet

 

15need that represents a new standard of care in this

 

16disease.

 

17In following this closely, it gives us the

 

18foundation we need to build a presence and a pipeline in

 

19solid tumor cancer. The importance of this agent is

 

20further reflected in its targeting of TROP-2 which has

 

21shown overexpression in multiple tumor types, including

 

22non-small cell lung cancer, urothelial cancer, hormone

 

23receptor positive for 2-negative breast cancer and

 

24others.

 

25Let me specifically pick up on one of the

 

 

 

 

 

 

1themes that Dan mentioned around unmet need. Despite

 

2available therapies, triple-negative breast cancer

 

3remains a difficult to treat tumor that

 

4disproportionately affects younger women and has poor

 

5outcome. The transformative nature of Trodelvy is

 

6reflected in the FDA accelerated approval based on the

 

Page 8

 

 

7phase 1-2 trial. And in that study we saw an impressive

 

833 percent overall response rate compared to the

 

9standard of care chemotherapy response rate if it were

 

10less than 20 percent.

 

11The confirmatory randomized phase 3 ASCENT

 

12study in TNBC patients, who were patients who had

 

13received two or more prior therapies for metastatic

 

14disease, further demonstrated the benefit of the drug.

 

15In particular, it's notable that this study was stopped

 

16early due to the compelling efficacy seen with the

 

17progression pre-survival signal of 5.8 months compared

 

18with the control arm of chemotherapy of 1.7 months.

 

19This had a P value of less than point 0001.

 

20Importantly, Trodelvy was generally well

 

21tolerated in this study with the most common adverse

 

22events being neutropenia and diarrhea. Additional data,

 

23including the overall survival data that we've had the

 

24opportunity to review during our diligence will be

 

25available at ESMO this coming week.

 

 

 

 

 

 

Page 9

 

1The data for Trodelvy suggests that it's a

 

2potentially transformative therapy in the treatment of

 

3triple-negative breast cancer. Importantly, upcoming

 

4clinical trials will also explore the potential benefit

 

5across a range of expanded tumor types in earlier lines

 

6of therapy. With potential breadth of Trodelvy in solid

 

7tumors is a really compelling prospect for us in terms

 

8of expanding the benefit to other patient groups.

 

9Importantly, this includes a pivotal phase 2 study

 

10called TROPHY U-01 in patients with metastatic

 

11urothelial cancer following prior treatment with

 

12platinum-based chemotherapy.

 

13We look forward to multiple presentations

 

14at the upcoming ESMO Conference, and this will highlight

 

15some of this work as well as other work exploring

 

16special combinations with PARP inhibitors and checkpoint

 

17inhibitors. Let me hand off the call now to Johanna.

 

18MS. MERCIER: Thanks, Merdad. So I really

 

19echo the excitement around this acquisition as well,

 

20especially from a patient need perspective. There's

 

21clearly a very significant unmet need for new treatment

 

22options in metastatic triple-negative breast cancer that

 

23improves survival for patients. Later line

 

24triple-negative breast cancer currently primarily

 

25treated with conventional chemotherapy and outcomes are

 

 

 

 

 

Page 10

 

1poor as Merdad was mentioning. The remarkable top line

 

2results from the ASCENT study in third-line patients has

 

3understandably generated significant enthusiasm by both

 

4physicians and patients. Full results will be shared

 

5later this week at ESMO and this enthusiasm should only

 

6continue.

 

7Trodelvy's strong efficacy profile has led

 

8to early adoption in both academic and community

 

9settings since its commercial launch in late April with

 

1020 million net sales in the first two months of launch.

 

11Its rapid launch uptake in the challenging environment

 

12of a pandemic speaks to the strong science and the

 

13flawless execution of the team. The field force has

 

14been very focussed in its early efforts on the top 150

 

15breast cancer accounts in the U.S. in which penetration

 

16has exceeded 80 percent and continues to grow.

 

17We really look forward to supporting and

 

18expanding the successful launch in triple-negative

 

19breast cancer, preparing for an imminent launch in

 

20Europe and maximizing Trodelvy's potential across

 

21multiple solid tumor types and establishing a global

 

22footprint. So with that, I'll turn it over to Andy for

 

23the quote.

 

24MR. DICKINSON: Thank you, Johanna. I will

 

25briefly review the financial terms of the transaction

 

 

 

 

 

Page 11

 

1and then we will turn to questions. As indicated in our

 

2joint press release, Gilead and Immunomedics have

 

3entered into an agreement pursuant to which Gilead will

 

4acquire Immunomedics for $88 per share for a total

 

5purchase price of approximately $21 billion. We expect

 

6to commence a tender offer to acquire all of the

 

7outstanding shares of Immunomedics' common stock in the

 

8next two weeks.

 

9The tender offer is not subject to a

 

10financing condition, and we expect to fund the

 

11acquisition with approximately 15 billion of existing

 

12cash and approximately 6 billion in newly-issued debt.

 

13We expect to retain an investment-grade credit rating

 

14following the transaction. The transaction does not

 

15alter our stated capital allocation strategy, including

 

16our commitment to further develop our internal and

 

17external pipeline, as well as our commitment to maintain

 

18and grow our dividend over time.

 

19Once completed, we expect that the

 

20acquisition will substantially accelerate our revenue

 

21growth through the mid-2030s. We also expect that the

 

22transaction will be neutral to accretive to our non-GAAP

 

23EPS in 2023 and significantly accretive thereafter.

 

24Finally, we plan to update our financial

 

25guidance after the closing, which we expect to occur in

 

 

 

 

 

Page 12

 

1       the fourth quarter subject to regulatory approvals and

 

2 customary closing conditions. We will now open the call
3 to questions.  
4MALE SPEAKER: Thank you, sir. As a

 

5reminder, to ask a question you would need to press star

 

61 on your telephone. To withdraw your question, please

 

7 press the pound key. Please standby while we compile
8 the Q and A roster.  
9     I show our first question comes from the
10line of Geoffrey Porges from SVB Leerink. Please go

 

11ahead.

 

12DR. PORGES: Thank you very much and

 

13congratulations on the transaction. A couple of

 

14questions for you, Andy. Andy, looks as though

 

15consensus has full -- Trodelvy is heading towards

 

16$4 billion. What revenue do you think is sort of a

 

17good, break-even hurdle for the 21 billion purchase

 

18price? And then could you advise us on what sort of

 

19cost of capital you think is appropriate for a

 

20transaction such as this with an approved product in the

 

21current economic climate? Obviously, you have terrific

 

22access to the capital markets. And then, lastly,

 

23Merdad, could you talk a little bit more about the

 

24combination opportunities? For example, the PD-1, are

 

25you going to study it within the PD-1 from Arcus, and

 

 

 

 

 

 

Page 13

 

1then do you have plans to study it in combination with

 

2the CDK-46, and then have you had any discussions about

 

3our particular candidates? Thanks.

 

4MR. DICKINSON: Thanks, Geoff. As for the

 

5revenue opportunity, you know, we agree that this is a

 

6very substantial opportunity across, not only breast

 

7cancer, but other solid tumor indications over time.

 

8We're not providing specific revenue guidance as you

 

9would expect, but you know, we see a very significant

 

10opportunity in a number of ways when, as you heard from

 

11Dan earlier, and we're happy to talk about in greater

 

12detail.

 

13On the cost of capital, we look at the cost

 

14of capital in the same way as other companies of our

 

15size. We look -- in a transaction of this nature, we

 

16look at the transaction across a range of discount

 

17rates, we look at our cost of capital, which you know,

 

18hovers somewhere around 6 percent or below today. But

 

19you know, our hurdle rate is higher than that, Geoff,

 

20even though we don't provide specific guidance.

 

21We also look at transactions, as you know,

 

22based on the target assets weighted average cost of

 

23capital. In looking at it in any way, you know, we get

 

24to a place on intrinsic value where we're very

 

25comfortable with this acquisition and believe that it

 

 

 

 

 

 

Page 14

 

1will deliver substantial value for our shareholders over

 

2time.

 

3DR. PORGES: Thank you.

 

4MR. DICKINSON: with that, maybe I'll hand

 

5it off of Merdad.

 

6DR. PARSEY: Yeah, Geoffrey. Thank you for

 

7the question. And you're right, I think we do believe

 

8that there's a lot of potential here for combination.

 

9And I would think about combinations very broadly here.

 

10Depending on the tumor type and the stage of therapy, I

 

11think it's important that to note that that would

 

12probably entail different sorts of combinations in those

 

13settings.

 

14Having said that, the data for combinations

 

15with checkpoint inhibitors as well as for PARP

 

16inhibitors are very interesting to us and certainly

 

17having ZIM (phonetic) provides us a lot more flexibility

 

18in terms of designing studies we can to look at

 

19combinations across tumor types. So without a doubt,

 

20we'll be looking at that. Again, a lot of that is going

 

21to be driven by the tolerability profile that Trodelvy,

 

22and we think that really lends itself to those sorts of

 

23combinations, which is something we're excited about.

 

24DR. PORGES: Right. Thanks very much.

 

25MALE SPEAKER: Thank you. I show our next

 

 

 

 

 

 

1question comes from Michael Yi (phonetic), from

 

2Jeffrey's. Please go ahead.

 

Page 15

 

 

3MR. YI: Hey, thanks and good afternoon.

 

4Two questions. Can you maybe talk about your

 

5assumptions or thinking or confidence levels around the

 

6major indications that you ascribe in your thinking

 

7about the valuation in the 21 billion; breast, bladder,

 

8et cetera, et cetera?

 

9And then related to that, you made a

 

10comment about having seen additional data that the

 

11street hasn't seen. So could you just talk to that

 

12particularly as it relates to that HR positive phase 3

 

13breast cancer study and anything in the basket study?

 

14Thank you so much.

 

15MR. O'DAY: Yeah, Michael, why don't I

 

16start and then I'll quickly turn it over to Merdad. But

 

17I think, you know, in terms of the assumptions around

 

18the major indications, and Merdad can color this a

 

19little bit, I think it also gets back to the previous

 

20question around, you know, the multiple opportunity to

 

21have benefit for patients and also for revenue and

 

22shareholders. Clearly, the near term opportunities --

 

23well, the opportunity in our hand today is, of course,

 

24triple-negative breast cancer and the ability to move up

 

25in lines of therapy there, but then closely behind that

 

 

 

 

 

 

1is both bladder cancer data that you'll see at ESMO, and

 

2then also the hormone receptor positive data that, you

 

3know, is underway right now. And then one step maybe

 

4slightly, you know, at the next step up from those three

 

5indications is lung cancer and then beyond.

 

6So I would just say that, you know, in

 

7terms of our assumption base, there's obviously lots of

 

8assumptions that you can get into by looking at the

 

9early data and try to project that to the later data,

 

10but we also know in oncology that particularly sometimes

 

11those play out and sometimes those don't play out. So I

 

12just want to make sure that you understand that we --

 

13we've looked at this in binary scenarios by indication

 

14as we looked at intrinsic value as well and, obviously,

 

15moving up to earlier lines of therapy.

 

16I'll let Merdad speak a little bit more

 

17about -- you can fill in on the assumption side if you

 

18like, Merdad, or also the additional data.

 

19DR. PARSEY: Yeah, Michael. You know, I

 

20think Dan pretty much said everything I was going to

 

21say. I think our -- obviously triple-negative being

 

22with the accelerated approval is at the highest part of

 

23our confidence level. I think breast cancer more

 

24broadly speaking also as we see the data, we're very

 

25excited about and I think we have -- could really impact

 

 

 

 

 

 

1some patient care there. And so those are at our

 

2highest list. I think for the urothelial cancer as

 

Page 17

 

 

3well, we've seen really promising data, and as you get

 

4farther down into like non-small cell, there's less

 

5data, of course, and -- but we're impressed by all of it

 

6across the board and we think there's promise there.

 

7I can't speak obviously to the embargo data

 

8that will show at ESMO this week, but I think as you see

 

9those data and you see the combination data as well, I

 

10think you'll start to see sort of where our excitement

 

11comes from in terms of building this, the base for this

 

12molecule.

 

13MR. O'DAY: And Michael, not to be

 

14specific, but obviously we've seen data beyond the data

 

15that we've presented at ESMO that maybe presented at

 

16future conferences as well. And as you can imagine, we

 

17can't tip our hat to that at this stage, but you know,

 

18we had a really good thorough look at this. It's

 

19important to note that we started this partnering

 

20process almost six months ago and, of course, we've

 

21developed a really nice relationship with Immunomedics

 

22over that period of time. And data has become available

 

23over those six months that we've been able to be exposed

 

24to under diligence and confidentiality. And that's

 

25only, you know, increased our enthusiasm around the

 

 

 

 

 

1potential here.

 

Page 18

 

 

2MR. YI: Yeah, that's what I mean, thank

 

3you.

 

4MALE SPEAKER: Thank you. Our next

 

5question comes from the line of Evan Seigerman from

 

6Credit Suisse. Please go ahead.

 

7MR. SEIGERMAN: Hi all. Thank you so much

 

8for taking my question and congrats on the transaction.

 

9So with this relatively large scale transaction, Andy,

 

10could you kind of quantify how much more capacity you

 

11have for additional business development, and can you

 

12specify to whether or not this one's on your radar,

 

13ahead or after the CRL for filgotinib? I'm just trying

 

14to get a sense as to how this fits in strategically.

 

15Thank you.

 

16MR. O'DAY: Yeah, let me just take the

 

17second question while Andy, you take the first. I think

 

18it's really important to note that there was no

 

19connection between this and the CRL with filgotinib.

 

20But let me first address this CRL with filgotinib by

 

21saying that, you know, clearly, as often happens you see

 

22regulatory authorities in different countries taking

 

23different accessions (phonetic) on filgotinib and CRL

 

24and, you know, we're fully committed to continuing to

 

25explore and understand better the CRL with FDA and see

 

 

 

 

 

1where that leads us, but that has nothing to do, of

 

Page 19

 

 

2course, with our desire to expand our transformational

 

3medicines either, you know, continuing in inflammatory

 

4(unintelligible) virology nor oncology.

 

5So this was part of our broader objective

 

6to deliver more than 10 transformative medicines over

 

7the next 10 years. And what started, as I said, well

 

8before we actually knew the regulatory cost of

 

9filgotinib, but was started the discussions -- well, we

 

10knew of this agent, of course, quite long ago. And the

 

11discussions started, as I said, many months ago as well.

 

12Andy, over to you for the deck capacity.

 

13MR. DICKINSON: Great. Hey, Evan, thanks

 

14for joining the call. You know, prior to the

 

15transaction if you look at most analyst assumptions

 

16which were generally consistent with our internal model,

 

17we had well over $40 billion of total fire power with

 

18the cash and the financing capacity that we had. So

 

19we're using a reasonable chunk of that here, but we have

 

20significant fire power going forward. I mean, the other

 

21thing I would highlight is you don't do a $21 billion

 

22deal every year, right?

 

23So we absolutely have the capacity to

 

24continue to do ordinary course business development

 

25transactions, transactions similar to the Forty Seven

 

 

 

 

 

 

1transaction. We have plenty of cash to support and grow

 

2our dividend over time which is really important to us

 

3as well. So we're very comfortable with where we are on

 

4a pro forma basis after closing of this transaction.

 

5Thank you.

 

6MR. SEIGERMAN: Thank you.

 

7MALE SPEAKER: Thank you. Our next

 

8question comes from Robin Conoscos (phonetic) from

 

9Truist. Please go ahead.

 

10MS. AHN: Hi, and good afternoon. This is

 

11Nicole Ahn (phonetic) for Robin form Truist. And

 

12congrats on the deal as well and thanks for taking our

 

13question. So on the slide deck on the guidance and the

 

14accretive impact, is this assuming filgotinib is

 

15factored in or without it? And I apologize if this has

 

16already been mentioned.

 

17MR. DICKINSON: Yeah the EPS -- you know,

 

18being EPS neutral is looking at a pro forma basis with

 

19the impact of this, right. So it's separate and apart

 

20from filgotinib, which we'll provide updated thoughts on

 

21where we -- where we see filgotinib going in the coming

 

22months and quarters as we finish our discussions with

 

23our partner and with regulators. So on a standalone

 

24basis as you fold this in, we expect this to be neutral

 

25to accretive in 2023 and significantly accretive

 

 

 

 

 

 

1 thereafter.  
2   MS. AHN: Okay, great, thanks so much.
3   MR. DICKINSON: Thank you.
4   MALE SPEAKER: Thank you. Our next
5question comes from Alethia Young from Cantor

 

6Fitzgerald. Please go ahead.

 

7MS. YOUNG: Hey guys, thanks for taking my

 

8question. Congrats on the deal. I guess, the question

 

9for me is obviously this is a pretty large scale deal

 

10that we've seen in the history of Gilead. So I guess

 

11I'm just trying to understand, are you making a core

 

12investment in hematology, oncology -- sorry, my dog

 

13likes your deal, too -- and you know, how (inaudible)

 

14five years from now --

 

15MR. O'DAY: Good taste, good taste that

 

16dog. Alethia, can you repeat the end of your question?

 

17MS. YOUNG: Just obviously looking at Gil'

 

18five years from now, is hematology oncology accompanied

 

19with HIV, or are you going to diversify beyond that, you

 

20think?

 

21MR. O'DAY: Oh, okay. Look, I think you

 

22know, it's really important that you understand that

 

23we're following our strategy which has two elements to

 

24it as its core. Number one, you know, we believe that

 

25we want to continue building on our scientific base we

 

 

 

 

 

1have in the area of virology and also inflammatory

 

Page 22

 

 

2disorders as immunomodulatory disorders and that lends

 

3itself to cancer and inflammation. And I think we'll

 

4follow the science. In other words, what's most

 

5important to us is that we can make a transformational

 

6 difference of patients and that's really what we're
7 driven by.  
8   So personally, I think, you know, that the
9 three pillars we have in our business, you know, we're
10certainly not -- let me just say, we're certainly not

 

11done with HIV, right? I mean, we have more to do there,

 

12we're excited about the capsid inhibitor, we have lots

 

13of research activities going on there in virology and

 

14beyond that. Of course, you've seen the benefit of that

 

15for emerging viruses with the medicine like remdesivir.

 

16Likewise, in inflammatory disorders we have a large

 

17investment both in house with our partners like

 

18Galapagos that we're firmly committed to.

 

19And then finally now, this gives us a third

 

20leg in oncology and hematology. It'd be hard for me to

 

21imagine or to project in five years or ten years, you

 

22know, the size of any one of those pillars, because that

 

23will be driven by the uncertainties of science and how

 

24we're going after the unmet medical needs. But it's

 

25really important that you know that we're firmly

 

 

 

 

 

 

1committed to all three of those areas, which is why the

 

2previous question on acquisition capacity and our

 

3ability to continue to flush out those areas as the

 

4science evolves.

 

5It's important we'll remain focussed on

 

6that and very importantly, bringing in the best talent

 

7from outside into our company to be able to make those

 

8decisions. And maybe I'll just finalize on that talent

 

9equation, because in addition to, of course, the great

 

10colleagues we have at Kite and Gilead in oncology,

 

11welcoming the Immunomedics talent to our family and the

 

12opportunity that Trodelvy brings, I think that also

 

13becomes a talent attraction and a talent magnet for

 

14people that want to really make a difference for cancer

 

15patients.

 

16They want to come to companies that have

 

17unmarked products that are near term, plus highly

 

18innovative things that are earlier term. And with this

 

19portfolio I think that gets us a great human capital

 

20attraction as well, but all three areas we need that

 

21human capital in.

 

22MS. YOUNG: Awesome, thank you. Congrats.

 

23MR. O'DAY: Thanks, Alethia.

 

24MALE SPEAKER: Thank you. Our next

 

25question comes from the line of Carter Gould from

 

 

 

 

 

1Barclay's. Please go ahead.

 

Page 24

 

 

2MR. GOULD: Good afternoon, guys. Congrats

 

3on the deal. I guess two -- I guess, first off, can you

 

4just comment for, I guess, first around sort of the

 

5level of comfort with the competitive environment and

 

6your internal assumptions around how you see that sort

 

7of playing out? Obviously, Immunomedics has (inaudible)

 

8first-mover advantage but there our competitors there.

 

9And then secondly, just now, how you view sort of the

 

10split in terms of R&D focus between hem-onc and solid

 

11tumors and if this is closer to serve your target

 

12balance? Any color there would be appreciated. Thank

 

13you.

 

14MR. O'DAY: So maybe I'll start on the

 

15second question and turn the first question over to

 

16Merdad. And Merdad, you can also -- but I think on this

 

17balance between investment and hem-onc versus solid

 

18tumors, again, you should hear directly from Merdad on

 

19this, but I think the point is we'll follow the science.

 

20So I think wherever we think we could have the biggest

 

21impact on patients is where our investments will go.

 

22And Merdad is putting together, you know, a portfolio

 

23group and committee and decisionmaking process of Gilead

 

24that's complimentary to the one at Kite that allows us

 

25to kind of make those investment decisions based upon

 

 

 

 

 

 

1data. And so you know, I think it'd be hard to predict

 

2what the split will be between those two.

 

3But of course, we've been heavier on

 

4hematology side because of Kite and the recent

 

5acquisition of Forty Seven in terms of late stage. And

 

6now, this kind of fast forwards it for solid tumors, so

 

7it certainly brings forward the immediate opportunity in

 

8a much bigger way for solid tumors which we're excited

 

9about. Merdad?

 

10DR. PARSEY: Yeah. The only thing I'd add

 

11to that is, you know, I think to embellish on what Dan

 

12said, you know, we are focussed on making an impact and

 

13having an impact on patients. And rather than sort of

 

14saying we want a certain percent team or a certain

 

15percent solid tumor, as Dan said, we'll follow the

 

16science and go after the place where we think we can

 

17have the biggest impact. So we don't have a quota we're

 

18trying to fill or anything like that.

 

19In terms of competition, I think it's safe

 

20to assume that in oncology there's always competition

 

21and, you know, we think about both the in-class and the

 

22broader competitive space within each of the therapeutic

 

23areas that we're interested in. Certainly for the in-

 

24class competition we're excited that we're out ahead,

 

25you know, and we're farther along and obviously approved

 

 

 

 

 

 

1with the accelerated approval. I don't think we can be

 

2complacent about that and we'll have to continue to

 

3explore the molecule as aggressively as possible to show

 

4the benefit of Trodelvy in various patient populations.

 

5And then, you know, more broadly in

 

6different tumor types, you know, I think what we can

 

7bring is a orthogonal approach to some of the other

 

8approaches people are taking in those tumors and

 

9hopefully add to them and hopefully move up in lines of

 

10therapy so that we can look at unique combinations as

 

11we've mentioned, things like PARP inhibitors in some

 

12tumor types, maybe IO in other tumor types. And I think

 

13that allows us to move up into earlier lines of therapy.

 

14So we'll be looking at that very broadly in order to

 

15maintain our competitive edge, both in class and outside

 

16of class.

 

17MR. GOULD: Thank you.

 

18MALE SPEAKER: Thank you. Our next

 

19question comes from Phil Nadeau from Cowen and Company.

 

20MR. NADEAU: Good afternoon. Let me add my

 

21congratulations on the deal. Couple questions from me

 

22on the upcoming data events. So it sounds like you've

 

23been able to see and fully review the urothelial data

 

24that we're going to see next weekend at ESMO. I'm

 

25curious, what does your due diligence say about the

 

 

 

 

 

 

1ability of that single-arm face to support an FDA filing

 

2and approval?

 

3And then second, there has been some

 

4controversy among Immunomedics investors about the

 

5timing of the interim analysis in the ER positive/HER2

 

6negative breast cancer study. What does your diligence

 

7say about the timing of that analysis, and certainly, do

 

8you think that that analysis will support an FDA filing?

 

9DR. PARSEY: Andy, do you want me to take

 

10that?

 

11MR. DICKINSON: Sure, yes.

 

12DR. PARSEY: Yeah, okay, happy to take it.

 

13So we do think that, obviously, we're optimistic about

 

14the ability to file triple-negative this year. When we

 

15look forward in triple-negative we think that we'll be

 

16able to continue to expand in the EU. And then we are

 

17optimistic about our chances to be filing for urothelial

 

18hopefully for accelerated approval based on the data as

 

19we think about 2021 and beyond.

 

20After that, it obviously becomes a little

 

21bit more grey, but we do hope for, you know, as the data

 

22emerged that we do see the possibility of multiple

 

23additional sBLAs coming up in the next few years.

 

24MR. O'DAY: And the other question was the

 

25timing of the in interim on the arm receptor positive.

 

 

 

 

 

 

1Merdad?

 

2DR. PARSEY: Oh, yeah, sorry. And that

 

Page 28

 

 

3should be next year. That should be next year. We're

 

4looking at sort of the second half of next year for

 

5those data. Sorry.

 

6MR. NADEAU: And do you think that'll

 

7support an FDA filing?

 

8DR. PARSEY: It's possible. I think we're

 

9kind of thinking about that's -- the potential for that

 

10would be obviously in 2022 and beyond, depending on the

 

11outcome. That's possible that we could have that, but

 

12obviously, we haven't seen those interim data, right?

 

13So that's speculation. But hopefully, we'll do the

 

14interim and if it does support it we would go for a

 

15filing in 2022.

 

16

 

17 questions and congrats again 18     MR. DICKINSON: 19     MALE SPEAKER:  

MR. NADEAU: Great. Thanks for taking my on the deal.

 

Thanks, Phil.

 

Thank you. Our next

 

20question comes from Brian Abrahams from RBC Capital

 

21Markets. Please go ahead.

 

22MR. ABRAHAMS: Hey guys, thanks for taking

 

23my questions and my congrats on the deal as well. How

 

24are you thinking about the launch ramp for Trodelvy and

 

25the potential for commercial synergies there? And then

 

 

 

 

 

 

1can you talk about the long-term leveragability of their

 

2ADC technology? Thanks.

 

3MR. O'DAY: Johanna, do you want to take

 

4the launch one?

 

5MS. MERCIER: Yep, sure. So Brian, I think

 

6what we've seen so far is, obviously, the first two

 

7months that Immunomedics have spoken to about in their

 

8earnings call this summer, and obviously a very strong

 

9start, we've also seen some pretty powerful data around

 

10not only the awareness of Trodelvy in the marketplace

 

11with oncologist that treat breast cancer, but also their

 

12intent to prescribe. And I think what we're seeing is a

 

13really nice ramp up and that's really kudos to the

 

14Immunomedics team for making sure that happens in such a

 

15quick time, both from a physician education standpoint

 

16but also from an access standpoint in making sure that

 

17there's no barriers for patients.

 

18So I think they're off to a very strong

 

19start. I think the opportunity is, obviously, to

 

20continue to grow that and potentially expand even the

 

21footprint as we think about moving it forward, not only

 

22in triple-negative breast cancer but other areas as

 

23well. So I think we're excited about that, let alone

 

24the fact that, you know, the intent is to file a

 

25submission in Europe early next year, and obviously

 

 

 

 

 

 

1follow up very quickly in Europe and beyond that to

 

Page 30

 

 

2really maximize the opportunity with a global footprint

 

3that Gilead already has. So I do think that the

 

4opportunity from a launch uptake over the next 18 to 24

 

5months are quite large.

 

6MR. O'DAY: Thanks. And long-term

 

7potential on the ADC, I mean, Merdad, of course, you may

 

8have some insights there.

 

9DR. PARSEY: You know, I think that

 

10certainly what's -- I think a lot of people have been

 

11struggling with ADCs for a long time and what we're

 

12excited about, what we're seeing on the therapeutic

 

13potential here of this platform, so it's definitely

 

14something that we will consider as we get into that.

 

15Certainly, the ability to deliver the payload here with

 

16this particularly linker is promising in

 

17triple-negative, so we have to think about what other

 

18antibodies and antigens we can go after to try to expand

 

19the utility. So we'll definitely be considering those

 

20going forward.

 

21MR. ABRAHAMS: Got it. Thanks again.

 

22MR. O'DAY: Thanks, Brian.

 

23MALE SPEAKER: Thank you. Our next

 

24question comes from Matthew Harrison from Morgan

 

25Stanley. Please go ahead.

 

 

 

 

 

1MR. HARRISON: Great, good afternoon,

 

2thanks for taking the question. I guess two for me.

 

3One, can you just talk about your view on competitive

 

Page 31

 

 

4differentiation versus passive. And then secondly, just

 

5from a strategic standpoint, I think previously you've

 

6talked about for oncology pursuing what I call more IO

 

7adjacencies in IO type products, and it seems more like

 

8a more traditional solid tumor product, so should we

 

9think about you expanding the breadth of the kinds of

 

10product you'd like to bring in? Thanks.

 

11MR. O'DAY: Yeah, let me -- thanks Matthew

 

12for the thoughtful question and I'll let Merdad speak

 

13about your first one on the competitive differentiation

 

14of padsil (phonetic). But I think on the second one,

 

15and I'll give you my viewpoint and Merdad as well can

 

16give you his. I think, you know, of course, we continue

 

17to remain interested on the cutting edge aspect of

 

18oncology and a great deal that is immuno-oncology today

 

19which has been our focus based upon, you know, some of

 

20our scientific background in immunomodulation, which

 

21adds some links back into virology and other scientific

 

22foundations we have in the company.

 

23Having said that, we've always said that we

 

24would remain opportunistic on adjacencies. And I think

 

25this is very connected mechanism versus IO in our

 

 

 

 

 

1opinion. Scientifically, of course, it's targeted

 

2towards TROP-2 expression, it's broadly applicable to

 

Page 32

 

 

3solid tumors, and because of its profile, we think it's

 

4combinable, of course, not just with IO but could very

 

5well be, you know, one of the biggest opportunities

 

6could be combinability with IO.

 

7So I think it really fits into our

 

8strategy, number one, but number two to our point, you

 

9know, it could have us alter our strategy, right? The

 

10strategy should never be set in stone, and a lot of our

 

11experiences, many of us have decades of experience in

 

12oncology strategy, one thing you know is you've gotta

 

13stay nimble and ready to kind of move and rotate.

 

14It reminds me of the old ADC days that

 

15Genetech and Roshrem (phonetic) we had, you know, dozens

 

16of ADCs that we thought after concile were just going to

 

17come pouring out. And the story there was that it

 

18wasn't quite as easy to get an antibody linker and toxin

 

19to be -- to hit that sweet spot of efficacy and safety.

 

20And that's why we're so impressed by the way -- what

 

21Immunomedics has done with Trodelvy.

 

22So I think the bottom line is that, yes,

 

23we'll continue to focus on IO, yes we have great

 

24modalities and housed some cell therapy and non-cell

 

25therapy and those are building. And I think, you know,

 

 

 

 

 

1this may have us rethink how we are inclusive in

 

2oncology strategy, you know, of other modalities and

 

3other mechanisms. So stay tuned on that. I mean,

 

4clearly with this being such a potential foundational

 

Page 33

 

 

5molecule for lots of tumor types, not only within Gilead

 

6but also outside of Gilead, you know, we'll continue to

 

7look for partnership opportunities. And certainly,

 

8Immunomedics already has, you know, a line of folks that

 

9are interested in looking at combinability of their

 

10agents with Trodelvy and nothing on that will change as

 

11we go into the next phase of Trodelvy's growth.

 

12Merdad, please.

 

13DR. PARSEY: Yeah, yeah. And ongoing --

 

14just to finish that point, you know, and emphasize is

 

15ongoing combination trials with molecules from other

 

16companies. And we'll continue to do that and look to

 

17those readouts because I think they'll be very

 

18important. As far as the comparison that

 

19(unintelligible), I think certainly the data continued

 

20to evolve. What we are excited about is that Trodelvy

 

21brings a very different safety profile as well as

 

22efficacy, right, so I think it's important to look at

 

23both sides of that.

 

24And so we're fairly confident as the data

 

25mature that there will be a role for Trodelvy that will

 

 

 

 

 

Page 34

 

1be complimentary to that for the competitor molecules in

 

2this space primarily because of the difference in

 

3tolerability. I think there's -- it's a very different

 

4profile and I think in this -- there's specific things

 

5about some of the more frail patients and urothelial

 

6cancer, that difference in the adverse event profile may

 

7afford patients a really great choice in terms of

 

8treatment options there. So we think there's a

 

9differentiating effect there from the safety standpoint

 

10as well as efficacy.

 

11MALE SPEAKER: Thank you. I show our next

 

12question comes from Terence Flynn from Goldman Sachs.

 

13Please go ahead.

 

14MR. FLYNN: Hi. Thanks for taking the

 

15questions and appreciate all the color. Just had a few.

 

16Was wondering what you guys were assuming for Trodelvy

 

17IP particularly given it's an ADC that goes out longer.

 

18And then on the sales force side, can you just provide

 

19any detail there in terms of the size of the current

 

20sales force, plans for Europe, and then any leverage

 

21opportunity with your current sales force? And then on

 

22the drug pricing side, you know, obviously, there's some

 

23uncertainty into the U.S. election, just wondering as

 

24you thought about your models here, with respect to

 

25longer-term pricing dynamics anything of note, or did

 

 

 

 

 

1you already factor in a pretty conservative pricing

 

Page 35

 

2outlook? Would just be curious to get some color there.

 

3Thank you.

 

4MR. O'DAY: Andy, do you want to do the IP

 

5and then Johanna, you can do some of the sales force and

 

6a bit of pricing. I could also do some pricing, too, if

 

7you like.

 

8MR. DICKSON: Yeah, I'd be happy to start.

 

9I think -- Terence, thanks for the questions. At a high

 

10level, I think we're not providing specific guidance.

 

11What we'd say is we're very comfortable with the IP

 

12estate well into the 2030s. Obviously, anti body drug

 

13conjugates are unique and have multiple layers of patent

 

14estates, but we're very comfortable that this asset will

 

15have IP protection well into the 2030s. Johanna?

 

16MS. MERCIER: Yeah, thanks, Andy. And so

 

17maybe going on first to the field force coverage that

 

18you're referring to, I think two things. I think

 

19Immunomedics has a good coverage today across the United

 

20States. I think there might be some opportunities

 

21potentially expand and even leverage some of the work

 

22that's going on with Kite as well, since Kite is very

 

23well established in the academic setting. And so the

 

24interplay between academia and community is going to be

 

25very important. And right now, the split is about

 

 

 

 

 

170/30; 70 community, 30 academic is where they're

 

Page 36

 

2looking at their current business. And I think there's

 

3probably an opportunity to continue to evolve that.

 

4I think to your question to Europe,

 

5obviously, that's something we're going to take on

 

6pretty quickly. I do think we have previous models of

 

7what an oncology footprint would look like in Europe,

 

8and it's a little bit of a different setting than in the

 

9U.S., but I think we feel confident that we can ramp it

 

10up pretty quickly over the next few months as we look at

 

11the model and the timing, of course, both for regulatory

 

12approval, but as you know, reimbursement takes a little

 

13bit longer in many markets.

 

14And then the last piece of the puzzle about

 

15drug pricing, obviously, this is a market-approved

 

16product, so the U.S. pricing assumptions were a little

 

17bit easier and, of course, as we look at the outlook,

 

18we've been just as conservative about our outlook as we

 

19look at our own product portfolio and applied similar

 

20assumptions, similar within the U.S. and also outside of

 

21the U.S. as we think about Europe, for example.

 

22Hopefully that addresses -- I don't know,

 

23Dan do you want to add anything to that?

 

24MR. O'DAY: No, not really, Terence, I

 

25mean, I think that's exactly what I wanted to say is

 

 

 

 

 

1that we're always quite conservative when we do these

 

Page 37

 

2types of modelings around both the continued decline in

 

3Europe and somewhat stable in the United States. Having

 

4said that, have we factored it in every scenario in the

 

5U.S. for any of our products? No. I remain convinced

 

6that, A, we need reform on drug pricing in the United

 

7States. And B, we have to make sure that patients' out-

 

8of-pocket costs are the things we target, and that we

 

9most importantly, see reward innovation.

 

10And I remain convinced that we'll get to

 

11those types of policies. We've been rolling our sleeves

 

12up and we'll get there. But for medicines like this

 

13that have such a dramatic impact I think these are

 

14largely, you know, not the medicines and the focus, and

 

15I think one has to have a high differentiation on any

 

16environment that we're going to go into around the world

 

17in terms of drug pricing. And I, for one, really like

 

18the profile of this medicine as we approach whatever

 

19reforms may happen, not only in the United States, but

 

20everywhere in the world, because this really does have a

 

21very significant impact on patients. So that's -- the

 

22most important thing is to keep the bar high on

 

23innovation.

 

24MR. DICKINSON: Terence, one more point on

 

25your question. The regulatory and statutory exclusivity

 

 

 

 

 

1in the U.S. is also important as you think about the

 

Page 38

 

2exclusivity period around this antibodies in particular

 

3in the U.S.

 

4MALE SPEAKER: Thank you. I show our next

 

5question comes from the line of Jim Berkanoff (phonetic)

 

6from Wells Fargo. Please go ahead.

 

7MR. BERKANOFF: (Inaudible) Thanks for

 

8taking our questions and congratulations on the deal.

 

9Our first question is on manufacturing of the antibody.

 

10Obviously, Immunomedics is planning on using Samsung

 

11Biologics for expanded commercial supply. What is your

 

12strategy to maintain a tight constant grips on the

 

13antibody? And a second question is whether

 

14(unintelligible) interest in the Koch Organization, how

 

15you feel about ADC, the ADC platform and cell therapy as

 

16part of an integrated option for a specific target.

 

17Thank you.

 

18MR. O'DAY: Thanks. Maybe Andy and Merdad?

 

19MR. DICKINSON: Yeah, I'll start on the

 

20manufacturing side. As you'd expect, I mean, there's a

 

21lot of history here on the manufacturing side with our

 

22CMC team has spent a lot of time with the Immunomedics

 

23team looking at this. It's a relatively complex

 

24manufacturing network relative to others given that you

 

25have either from parties toxin (phonetic) and the linker

 

 

 

 

 

1and the antibody and then pulling it all together.

 

2We're very comfortable with what they've done. They

 

3have a great team, we think they've done a great job.

 

4We're comfortable with our ability to scale it up.

 

Page 39

 

5Obviously getting Samsung in place was an important step

 

6for them as well, it gives us a lot of comfort.

 

7So we -- you know, the cost of goods here

 

8specifically to your question, are entirely in line with

 

9the rest of our portfolio at scale including, you know,

 

10standard kind of antibody and small molecule cost of

 

11goods. So there's nothing unique here other than you

 

12know with slightly different than your standard

 

13antibody, but that scale, we see every opportunity to

 

14get to a really attractive cost of goods. Merdad?

 

15DR. PARSEY: Yeah, and what I would say in

 

16terms of the cell therapy, potential cell therapy, we

 

17are very much focussed I would say primarily on the

 

18solid tumor area right now making sure that we keep our

 

19eye focussed on being successful and our core

 

20indications. Having said that, we always -- we're very

 

21close with our colleagues at Kite and always look at

 

22opportunities more broadly and will -- this would go

 

23into that bucket of we certainly consider potential

 

24synergies between cell therapy and TROP-2 targeted

 

25therapy.

 

 

 

 

 

1MALE SPEAKER: Thank you. Our next

 

Page 40

 

2question comes from the line of Mohib Bencil (phonetic)

 

3from Citi. Please go ahead.

 

4MR. BENCIL: Great, thanks for taking my

 

5question and congrats on the deal. Quick question. So

 

6communications -- I mean the goal was to bring the

 

7by-plane that some small (unintelligible) and this seems

 

8a little bit bigger than that, we just wanted to get

 

9your thoughts on what changed the thought process here

 

10and had it anything to do with the filgotinib action by

 

11that? Thank you.

 

12MR. O'DAY: Hey, Mohib. Yeah, Dan O'Day

 

13here. So the answer to the question is no, it had

 

14nothing to do with filgotinib. And what I would say is

 

15that, you know, I think this is very consistent with the

 

16strategy we laid out when I came in about a year and a

 

17half ago with the team here, which is, you know, to be

 

18disciplined about our scientific areas of strength and

 

19where we're going to play and where we're not going to

 

20play. And then secondarily, to do that with small to

 

21medium-sized bolt-on acquisitions. So I mean, given our

 

22market cap and ability, I think this clearly falls

 

23sweetly into the medium-sized bolt-on. It's

 

24particularly important, you know, because it's derisked

 

25from the standpoint of having, you know, on-market and

 

 

 

 

 

1approval to regulatory so that's obviously why it

 

Page 41

 

2becomes more of a mid-size bolt-on, but strategically as

 

3we talked about before, very much in line with our

 

4strategy. And I think you can expect us to do more of

 

5this.

 

6Now as Andy says, it's not every day we're

 

7going to do a $20 billion acquisition. We do have

 

8sufficient fire power still to put to work and we'll

 

9keep the threshold high on innovation.

 

10The other thing we'll do is we'll continue

 

11to be creative in terms of transaction structure. I

 

12think Andy and his team have been real creative about,

 

13you know, finding ways to partner with companies that

 

14allow each party to share the risk more fully until you

 

15get data, particularly on the earlier stage compounds,

 

16or some of the innovative type structures we've created

 

17that are very long-term research based and development

 

18based initiatives like we've done with Galapagos on a

 

19very sizable basis or ARCAS recently on the oncology

 

20basis.

 

21So I think making sure that we continue to

 

22pivot and have a really fit-for-purpose approach on our

 

23strategy as we think about small, medium-sized

 

24partnership acquisitions you'll continue to see us do

 

25that. And that's -- I think that takes a lot of work,

 

 

 

 

 

1it takes relationships, it takes knowledge, it takes

 

2know how, but at the end of the day I think it's the

 

Page 42

 

3best way to make sure that you're -- whatever, whoever

 

4your partnering with are acquiring but the innovation

 

5stays intact and complete, because at the end of the day

 

6it's about people, it's about getting them motivated,

 

7and different structures are required to get us there.

 

8So this is -- this is a medium-sized and it's

 

9transformational for our oncology business, but I think

 

10what you've seen in the past you can continue to expect

 

11to see in the future.

 

12MR. BENCIL: Very helpful, thank you.

 

13MALE SPEAKER: Thank you. Our last

 

14question comes from the line of Umer Raffat from

 

15Evercore. Please go ahead.

 

16MR. RAFFAT: Hi guys, thank you for taking

 

17my question. I have a few today, if I may, and I would

 

18appreciate you bearing with me on these. First Dan, I

 

19don't think anyone will question the quality of the

 

20asset or the strength of clinical data for Trodelvy, but

 

21the same asset with much of the same clinical data

 

22across indications was trading at less than 20 percent

 

23of the acquisition price during most of 2019. So how

 

24should we think about that especially also from a

 

25capital allocation perspective from Gilead, number one.

 

 

 

 

 

Page 43

 

1Merdad, a couple for you. I'm curious what

 

2do you think about Dychee's (phonetic), TROP-2 ADC,

 

3especially since it only needs one infusion per cycle,

 

4not two. And also, if you could speak to the response

 

5rate and know or low TROP-2 expressors both in UC and HR

 

6positive breast, and what percent (unintelligible) is

 

7that? Thank you very much.

 

8MR. O'DAY: Sure Umer, we always appreciate

 

9your questions and happy to take them. So on the first

 

10one, just to put your question into context and I think

 

11it's not uncommon to see share prices drop when you have

 

12remarkable clinical data, but in particularly in the ADC

 

13space, given what I said before about, you know, the

 

14halls of many companies and academic that have been

 

15littered with ADC that didn't show their promise, you

 

16know, it's not uncommon to be skeptical until you see

 

17clinical data.

 

18At the end of the day clinical data trumps

 

19I think everything. And so, of course, we saw an

 

20appreciation of the share price based upon the clinical

 

21data that's been publically made available so far. And

 

22then to remind you from what Andy said before, we look

 

23at this intrinsic value basis, a premium can often get

 

24confused and particularly in this one, I think the

 

25premiums are conflated by the fact that we have

 

 

 

 

 

Page 44

 

1information that the public doesn't have yet, given the

 

2upcoming ESMO meeting that you'll see next week. And

 

3clearly, you know, it's our assumption that the share

 

4price of Immunomedics also would have appreciated as a

 

5result of the ESMO data as well.

 

6So you take that into account when you look

 

7at the entirety of the premium, but all of that

 

8fundamentally is based on the clinical data both in

 

9triple-negative breast cancer and the early clinical

 

10data other indications that we talk about on this call,

 

11as well as some of the data that you'll see at ESMO

 

12around the early combinability. So that's really where

 

13the intrinsic value comes from and I'd much rather look

 

14at from that than where the share price was trading six

 

15months, nine months, 12 months ago.

16Merdad?

17DR. PARSEY: Yeah, I don't have -- in terms

18of the TROP-2 expression and I'd say it's really early

19days we -- I think we need to understand our

20relationship better that Immunomedics medics team has

21done a great job of looking at that. And I would say

22you know, the early data really intriguing in terms of

23the relationship between TROP-2 expression and response.

24But it'll take a lot more data for us to identify a cut

25point, what it looks like in different tumor types, what

 

 

 

 

 

Page 45

 

1it looks like in various lines of therapy. So I'd say

2it's really too early to draw too many conclusions

3there, but we'll have to gather more data to look at

4that. But certainly, I feel that it looks as though

5that higher levels of TROP-2 expression certainly seem

6to have better responses in the general sense. But

7we'll have to see how that evolves over time.

8And then in terms of comparison to

9(unintelligible) again, as I said earlier, I think it's

10hard to compare it, because they're at different stages

11of development in different patient populations with

12different background therapy. Having said that, one of

13the things that we like about, obviously, the

14Immunomedics molecule is not only its efficacy but also

15its safety profile. And as you've seen with the

16(unintelligible) molecule, they do see some interstitial

17lung disease that develops, and we haven't seen any

18evidence of that with the Immunomedics molecule.

19A lot of caveats around that, but we're

20heartened by the fact that the tolerability profile

21molecules needs to be really good and allows us to think

22about earlier lines of therapy and accommodations in

23ways that I think, you know, other molecules it would be

24harder to think about in that way.

25Hope that helps.

 

 

 

 

 

1                                    MR. RAFFAT: Thank you very much, guys.

Page 46

2MALE SPEAKER: Thank you. This includes

3our Q-and-A session. At this time I'd like to send the

4call back over to Mr. Douglas Maffei, Senior Director

5Investor Relations for closing remarks. Please go

6ahead.

7MR. MAFFEI: Thank you, Dalim (phonetic),

8and thank you all for joining us today. We appreciate

9your continued interest in Gilead and the team here

10looks forward to providing you with updates on our

11future programs.

12MALE SPEAKER: Ladies and gentlemen, this

13concludes today's conference call. Thank you for

14participating. You may now disconnect.

15                                    (End of audio file) 16

17

18

19

20

21

22

23

24

25

 

 

 

 

 

1       CERTIFICATION

2

3

4

5

6

7

Page 47

8                I, Carmel Martinez, TX CSR No. 8128, FPR No. 1065,

9do certify that I was authorized to and did listen to

10and transcribe the foregoing recorded proceedings and

11that the transcript is a true record to the best of my

12     ability. 13

14       Dated this 14th day of September, 2020. 15

16

17

18

19Carmel Martinez,

20TX CSR No. 8128

21FL FPR No. 1065

22

23

24

25

 

 

 TP

FORWARD-LOOKING STATEMENTS

 

This communication contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Immunomedics and the acquisition of Immunomedics by Gilead that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies’ and members of their senior management team. Forward-looking statements include, without limitation, statements regarding the business combination and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the ability of Gilead to advance Immunomedics’ product pipeline and successfully commercialize Trodelvy; expectations for achieving full U.S. Food and Drug Administration approval based on Immunomedics’ confirmatory data for Trodelvy and Immunomedics’ development of Trodelvy for additional indications; clinical trials (including the anticipated timing of clinical data; the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs); the possibility of unfavorable results from clinical trials; regulatory applications and related timelines, including the filing and approval timelines for Biologics License Applications and supplements; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Immunomedics’ stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; Immunomedics’ ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on Immunomedics’ products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory approval for Immunomedics’ products due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; adverse impacts on business, operating results or financial condition in the future due to pandemics, epidemics or outbreaks, such as COVID-19; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Immunomedics and the Schedule TO and related tender offer documents to be filed by Gilead and [Merger Sub], a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead and Immunomedics, and Gilead and Immunomedics assume no obligation and disclaim any intent to update any such forward-looking statements.

 

ADDITIONAL INFORMATION AND WHERE TO FIND IT 

 

The tender offer described in this document has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Immunomedics, nor is it a substitute for any tender offer materials that Gilead, Maui Merger Sub, Inc. or Immunomedics will file with the SEC. A solicitation and an offer to buy shares of Immunomedics will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Immunomedics will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. IMMUNOMEDICS’ STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be sent to all stockholders of Immunomedics at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Immunomedics. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement. Copies of the documents filed with the SEC by Immunomedics will be available free of charge under the “Investors” section of Immunomedics’ internet website at Immunomedics.com.

 

In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Immunomedics file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Immunomedics’ filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.