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Gilead Sciences, Inc. (GILD) CEO Daniel

O'Day on Q4 2021 Results - Earnings Call
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Feb. 01, 2022 8:02 PM ET | Gilead Sciences, Inc. (GILD)

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Gilead Sciences, Inc. (NASDAQ:GILD) Q4 2021 Results Conference Call February 1,

2022 4:30 PM ET

Company Participants

Jacquie Ross - VP, IR

Daniel O’Day - Chairman and CEO

Johanna Mercier - Chief Commercial Officer

Merdad Parsey - Chief Medical Officer

Andrew Dickinson - CFO

Christi Shaw - CEO, Kite

Conference Call Participants

Geoff Meacham - Bank of America

Mohit Bansal - Wells Fargo

Cory Kasimov - JP Morgan

Brian Abrahams - RBC Capital Markets

Salveen Richter - Goldman Sachs

Michael Yee - Jefferies

Ronny Gal - Bernstein

Colin Bristow - UBS

Hartaj Singh - Oppenheimer

Carter Gould - Barclays

Matthew Harrison - Morgan Stanley

Operator

Good day, and thank you for standing by. Welcome to the Gilead Fourth Quarter and
Full Year 2021 Earnings Conference Call. At this time, all participants are in a listen-
only mode. After the speakers’ presentation, there will be a question-and-answer
session. [Operator Instructions] Please be advised that today’s conference is being
recorded. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Jacquie Ross, VP
of Investor Relations. Please go ahead.

Jacquie Ross

Thank you, Gigi, and good afternoon, everyone.

Just after market close today, we issued a press release with earnings results for the
fourth quarter and full year 2021. The press release, slides, and supplementary data
are available on the Investors section of our website at gilead.com.
The speakers on today’s call will be our Chairman and Chief Executive Officer, Daniel
O’Day, our Chief Commercial Officer, Johanna Mercier, our Chief Medical Officer,
Merdad Parsey, and our Chief Financial Officer, Andrew Dickinson. After that, we’ll
open up the call to Q&A, where the team will be joined by Christi Shaw, the Chief
Executive Officer of Kite.

Before we get started, let me remind you that we will be making forward-looking
statements, including those related to the impact of the COVID-19 pandemic on
Gilead’s business, financial condition and results of operations; plans and expectations
with respect to products, product candidates, corporate strategy, business and
operations, financial projections and the use of capital; and 2022 financial guidance, all
of these involve certain assumptions, risks and uncertainties that are beyond our
control and could cause actual results to differ materially from these statements. A
description of these risks can be found in the earnings press release and our latest
SEC disclosure documents. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to update any such
forward-looking statements.

Non-GAAP financial measures will be used to help you understand the Company’s
underlying business performance. The GAAP to non-GAAP reconciliations are provided
in the earnings press release available on the Gilead website.

With that, I’ll turn the call over to Dan.

Daniel O’Day

Thank you, Jacquie. And good afternoon, everybody.

As we head into 2022, Gilead is coming off a year of positive clinical momentum and
strong financial performance, mitigating the impact of the pandemic on some parts of
our business. Higher sales of Veklury more than offset the impact of COVID-19 on HIV
and HCV. Veklury continues to play a critical role in helping to treat people with COVID-
19, with continued activity against the Omicron variant. The FDA recently expanded its
use beyond the hospital for patients at high risk of disease progression. In addition, we
just initiated a Phase 1 trial of GS-5245, a novel oral COVID19 nucleoside, that once
metabolized, works in the same way as remdesivir.
Our full year revenue for 2021 was 11% higher than the midpoint of our initial guidance
in February of 2021. It was also an important year for our transformation to becoming a
business that is based on diverse, sustainable growth.

In 2021, we received 7 approvals or accelerated approvals in the U.S. and Europe, and
submitted an additional 6 filings. Our approvals included: three for Trodelvy, with FDA
and MAA approval in second-line triple-negative breast cancer as well as an
accelerated approval from FDA for metastatic bladder cancer; two for cell therapy, with
Yescarta receiving accelerated approval in relapsed or refractory follicular lymphoma
and Tecartus receiving full approval in adult acute lymphoblastic leukemia; and two
expanded labels in virology, one for a pediatric label for Biktarvy in the U.S. and an
expanded label for Veklury in the E.U. for adults not requiring supplemental oxygen.

Our 2022 plans include a significant increase in clinical development studies across our
novel oncology portfolio. We are planning at least 20 additional trials, including 7 Phase
3 trials for Trodelvy. And these include: the ASCENT-03 trial, which is evaluating
Trodelvy in the front-line triple-negative breast cancer in the PDL1 negative population;
the ASCENT-04, in collaboration with Merck, to evaluate Trodelvy and Keytruda in
front-line triple-negative breast cancer population in the PDL1 positive population; and
the EVOKE-03, which will be led by Merck, to evaluate Trodelvy and Keytruda in non-
small cell lung cancer.

You will also see ongoing momentum in our virology portfolio as we continue to expand
our leadership in antiviral therapies. We are advancing our longer-acting HIV options
with lenacapavir as the foundation and look forward to potential regulatory decisions in
2022. If approved, lenacapavir would be the only HIV treatment option administered
twice yearly. In addition, we’ll continue to drive progress across our broader virology
portfolio, including hepatitis, COVID-19, and other emerging viruses.

This is a really important time in Gilead’s transformation journey. After the consistent
work to execute on our strategy and expand our portfolio over the last two years, you
will increasingly start to see this play out in tangible results. We’re confident that Gilead
has all the elements in place for a strong year and a strong decade.
Johanna, and Merdad and Andy will now take you through the details of our progress
and our plans. And let me hand first to Johanna to talk about our commercial
performance in the fourth quarter and the full year. And I’ll be back to you in the Q&A.
Johanna?

Johanna Mercier

Thanks, Dan. Good afternoon, everyone.

As you can see on slide 7, we had a strong end to the year with Q4 total product sales,
excluding Veklury, of $5.8 billion, up 7% quarter-over-quarter, driven by favorable
pricing and inventory dynamics. This also represented 8% growth year-over-year,
driven by continued recovery in the HIV treatment market and favorable pricing
dynamics. Veklury sales were higher than expected in Q4 reflecting the start of the
Omicron surge, but lower than both the prior quarter and prior year, and contributing to
total product sales of $7.2 billion for the quarter.

Moving to slide 8, total fourth quarter Veklury sales were $1.4 billion, bringing total
sales for 2021 to $5.6 billion. Gilead is proud of the role that Veklury continues to play
in this pandemic. Veklury has demonstrated activity against the Omicron variant and
has helped many patients with COVID-19 in the most recent surge. Although symptoms
have generally been less severe, the volume of overall cases has meaningfully
increased since the emergence of Omicron, and we have seen the total number of
hospitalizations increase as well. While we would all prefer to put this pandemic behind
us, we expect Veklury to continue to play a critical role in 2022 and beyond. As you
would expect, hospitalizations remain a key indicator for in-patient Veklury sales, and
we are seeing higher hospitalizations in geographies with lower vaccination adoption,
including certain parts of the U.S. as well as Eastern Europe. Additionally, I’m very
pleased to highlight that the FDA recently approved the sNDA filing for the use of
Veklury in the outpatient setting for patients at high risk of disease progression. This
approval was based on data generated in the Phase 3 PINETREE study, further
solidifying the credibility, importance and role of Veklury. Now Veklury will be available
to help even more patients earlier and reduce risk of hospitalization for COVID-19.
Next, as shown on slide 9, total HIV sales were $4.5 billion in the quarter, up 8%
sequentially driven by favorable inventory and pricing dynamics as well as changes to
our gross to net estimates in Q4 2021. For the full year, total HIV sales were $16.3
billion, down 4% year-over-year, primarily due to the Truvada and Atripla LOE, in
addition to pandemic-related impacts and pricing dynamics. The expected impact from
the LOEs, which amounted to $1.3 billion, was offset by continued Biktarvy growth.
Excluding the sizeable LOE impact, HIV total product sales for the full year grew 4%
compared to 2020 despite the ongoing pandemic headwinds. We now expect the
Truvada and Atripla loss of exclusivity impact to be minimal going forward as the
headwind dissipates starting in Q2 of this year.

In HIV treatment, we continue to see signs of market recovery although the U.S. market
declined 1% sequentially in Q4 following two quarters of sequential growth. On a year-
over-year basis, the overall market in Q4 was up 1.5% in both the U.S. as well as the
EU5, despite screening and diagnosis rates still below pre-pandemic levels. As you
know, favorable dynamics play out in the fourth quarter of every year in HIV, and 2021
was no different with some year-end inventory stocking and favorable seasonal pricing
as well as changes in our gross to net estimates in Q4 2021. As you think about 2022,
I’ll remind you of the normal HIV inventory build-up in Q4 and the New Year reset for
patient copays and donut hole payments. Given these factors, along with the favorable
pricing dynamics I just mentioned, we expect the sequential decline in Q1 ‘22 to be
greater than Q1 ‘21. Nonetheless, we expect a strong year overall in HIV and expect
continued growth in subsequent quarters.

Back to Q4, Biktarvy had another record quarter with sales of $2.5 billion, up 11%
sequentially and 22% year-over-year. On slide 10, you can see that Biktarvy U.S.
treatment market share has increased over 5 share points in 2021, reaching 42%,
which is the highest share that any complete regimen has ever achieved in this market.
For the full year, Biktarvy sales were $8.6 billion, growing 19% from 2020, and Biktarvy
remains the leading prescribed treatment for naïve and switch patients in the U.S. as
well as number 1 in naïve in EU5.
Descovy revenue for the fourth quarter was $473 million, up 9% quarter-over-quarter
primarily as a result of favorable seasonal pricing and inventory dynamics as well as
continued demand. We expect Descovy revenue to continue to be driven by PrEP as
Descovy has maintained about 45% of overall PrEP market prescriptions in the U.S.
We will continue to ensure access to support physician choice, and expect growing
demand and market expansion to offset the impact of increased commercial
contracting.

Overall, while near term growth continues to be impacted by local pandemic-related

social restrictions, we are encouraged by the growing PrEP market. In Q4, the overall
PrEP market grew 4% quarter-over-quarter, and 31% year-over-year. Looking forward,
we believe lenacapavir, our investigational longer-acting PrEP offering, could potentially
catalyze the market well beyond the 25% penetration rate in PrEP that we see today.

Moving to slide 11, it’s clear that HCV continues to be the part of our portfolio most
impacted by the pandemic. Although there was some slight quarter-over-quarter
recovery in market starts in the EU5, U.S. market starts declined, resulting in flat total
starts overall. While Gilead market share increased modestly on a sequential basis in
both the U.S. and the EU, this was more than offset by unfavorable pricing dynamics,
resulting in Q4 total sales of $393 million, down 8% sequentially and 7% year-over-
year.

As you can see on slide 12, our HBV and HDV franchise reported record quarterly
revenues of $265 million, up 7% sequentially due to seasonal inventory and favorable
pricing. The 9% year-over-year growth was primarily driven by Vemlidy demand. Total
fiscal year sales for this franchise were $969 million, up 13% year-over-year.

Hepcludex reported $12 million of sales in Q4 in Europe, with $37 million in 2021 sales
since our acquisition in late first quarter. Hepcludex is currently available in Germany
and France, in addition to a number of early access programs in countries such as
Austria, Italy, and Greece. In 2022, and as part of our comprehensive
commercialization plan, we expect to finalize reimbursement for launch in a number of
major European markets. In the U.S., we filed a BLA in November and FDA granted
priority review for accelerated approval, with a PDUFA date set for the third quarter and
an Advisory Committee meeting that will be scheduled in the coming months.
Moving to oncology, first with Trodelvy on slide 13, global sales were $118 million in the
fourth quarter, up 17% sequentially and up 84% year-over-year compared to full Q4
2020 sales. This reflects growing adoption of the second line metastatic TNBC triple-
negative breast cancer indication, which was noted as a preferred regimen in the
NCCN Breast Guidelines updated in September. We are also starting to see stronger,
unaided brand awareness which is resulting in continued market share growth.

In second-line TNBC, Trodelvy now captures approximately 1 in 4 new starts in the

U.S. We have expanded our oncology footprint globally, including tripling our U.S.
headcount to further accelerate penetration of Trodelvy and prepare for our potential
HR positive and HER2 negative launches. Additionally, EU approval for Trodelvy was
granted in late November 2021 and we have already seen strong momentum in France
and Germany since their launch. We plan to launch in a number of new countries
following key reimbursement decisions this year.

Now, on slide 14, on behalf of Christi and the Kite team, cell therapy Q4 sales of $239
million reflected 47% year-over-year growth, an 8% increase sequentially. For the
quarter, Yescarta sales of $182 million were up 41% year-over-year driven by continued
demand in relapsed or refractory large B-cell lymphoma and follicular lymphoma.
Tecartus sales of $57 million in the quarter reflected 68% year-over-year growth based
on growing global demand for relapsed or refractory mantle cell lymphoma and early
contribution from adult acute lymphoblastic leukemia in the U.S.

As a reminder, FDA granted Tecartus approval in adult ALL in October and in just the
first few months of launch, there has already been strong demand that we expect to
continue in the coming quarters given the high unmet need. Full year cell therapy sales
of $871 million reflected 43% year-over-year growth driven by continued LBCL and
MCL demand globally as well as the new launches. The strong growth we’ve seen with
these recent launches reinforces our belief that cell therapy adoption will continue its
positive momentum as more physicians understand the benefits for appropriate
patients and therefore increase referral rates to treatment centers.
Merdad will elaborate later, so I’ll just quickly mention the impressive data Kite
presented at ASH in December, 43% overall survival rate after five years in third line
LBCL patients. The Yescarta data at ASH not only highlighted the long-term real-world
safety and efficacy profile in third line LBCL, but also in earlier lines of therapy. For
ZUMA-7 data in second-line LBCL, FDA has set a PDUFA date of April 1st when we
hope Yescarta will be granted approval. In the meantime, the Kite team is ramping up
manufacturing capacity to meet the anticipated demand. Kite expects the new
Maryland facility to begin commercial operations by Q2. Combined with the Amsterdam
and El Segundo facilities, we expect to increase operational capacity by up to 50% by
the end of this year. Christi is here with the team and available to take questions on cell
therapy during our Q&A.

In closing, our oncology sales were $1.25 billion in 2021 and we expect robust growth
in the coming years. With that, I’ll hand it over to Merdad for pipeline updates.

Merdad Parsey

Thanks, Johanna. Good afternoon, everyone.

Building on what both Johanna and Dan have said, the Gilead team rounded out a very
strong 2021 with further progress across our portfolio. In 2021 alone, we began
enrolling patients in 13 oncology, 13 virology, and 4 inflammation trials, and we have
recently shared the initial details of the ambitious development programs we are
targeting for 2022. As we look forward, we are confident that we have the foundation to
continue to build a robust, diverse portfolio across our three focus therapeutic areas.
First, on slide 16, Veklury continues to play a vital role in the fight against COVID-19.
Veklury was the first approved treatment for patients hospitalized with COVID-19. We
have received expanded indication labels in the U.S. and EU. In December, the
European Commission approved a variation to the Conditional Marketing Authorization
for Veklury for the treatment of COVID-19 in adults not on supplemental oxygen. And
last month, based on data from the Phase 3 PINETREE study, the FDA expanded the
approval of Veklury to include non-hospitalized patients at high risk for COVID-19
disease progression. These expanded indications speak to the activity of Veklury
against the coronavirus variants we have seen so far, including Omicron. We believe
there will continue to be a need for Veklury delivered intravenously, especially for
higher risk patients. The potential for continued COVID-19 variants and infections
highlight the need for more convenient oral formulations to expand the options for
outpatients. As such, we have just initiated a Phase 1 trial of GS-5245, a novel oral
COVID-19 nucleoside, that once metabolized, works in the same way as remdesivir.
Pending data, the evolving pandemic landscape, and discussions with regulatory
agencies, we are hoping to initiate a registrational trial before the end of the year.

Moving to HIV on slide 17, we shared an overview of some of our long-acting

development activities a few weeks ago, to highlight the diversity of our portfolio and
how it targets the entire HIV life cycle. We continue to believe that our investigational
agent lenacapavir is a unique and foundational asset, given its potential for extended
dosing, in addition to the compelling efficacy and safety profile highlighted in the
CAPELLA and CALIBRATE studies.

Next, on slide 18, you can see our current clinical efforts with long-acting HIV
therapeutics. As previously announced, the Phase 2 study evaluating the oral
combination of lenacapavir with Merck’s islatravir is on partial clinical hold, and Merck
remains in discussions with FDA on next steps islatravir. In the meantime, we at Gilead
continue to develop a number of other potential partner agents for lenacapavir in HIV
treatment and look forward to sharing some more detail on these programs at our
Virology Deep Dive later this month.
We remain confident and excited about lenacapavir’s future potential to deliver options
for people living with HIV or those who could benefit from PrEP. I want to be very clear
that the recent clinical hold for the lenacapavir trials, which the FDA initiated in
December, is not associated with the lenacapavir molecule itself. Rather, the hold
reflects concern about the compatibility of certain vials with the lenacapavir solution.
We continue to work with the FDA to remediate the concern and to agree on a path to
resume these trials. We are hopeful this can be achieved quickly. As such, we continue
to expect an FDA decision for lenacapavir in heavily treatment experienced individuals
in the first half of 2022. If successful, lenacapavir will become the first available six-
month, long-acting subcutaneous injection for the treatment of HIV.

Next, moving to Trodelvy on slide 18, I’m pleased to confirm that we now expect to
share both top-line progression-free survival data as well as the first planned interim
analysis of overall survival from TROPiCS-02 in March. There’s been a convergence of
events for PFS and OS such that we will be able to conduct and report a single
analysis of these outcomes rather than have two analyses separated by a short
interval. Gilead remains blinded to the data, and we are excited to be able to share this
more complete view later this quarter.

We are targeting an sBLA filing in the second half of 2022, depending, of course, on
the readout. If the data are positive, we believe that Trodelvy could represent a very
important treatment option for HR+/HER2- patients who are hormone refractory and
have very limited options. Reflecting our confidence in Trodelvy overall, we are
expanding the number of clinical programs in 2022 to evaluate effectiveness in breast,
lung and bladder cancers, with plans to initiate study start-up activities for at least 7
Phase 3 trials. Three of these are expected to enroll their first patients in 2022,
including two in front line metastatic TNBC and another in front-line non-small cell lung
cancer study that will be led by Merck. Going forward, we will separately disclose trial
start up activities versus FPI milestones.

Additionally, in the first half of this year, we plan to add a combination of Trodelvy with
other Gilead portfolio assets as a study or an additional cohort in an existing study. We
look forward to sharing more details at our upcoming Oncology Deep Dive in April. This
is another example of the versatility and tremendous potential that Trodelvy, along with
the growing oncology portfolio, can generate.
Next slide, onto magrolimab. Early last week, the FDA placed a partial clinical hold
pausing enrollment and screening in trials and cohorts in the U.S. evaluating
magrolimab in combination with azacitidine following review of a preliminary data set
suggesting an apparent imbalance in investigator reported SUSARs, or suspected
unexpected serious adverse reactions, between treatment groups in our ongoing
Phase 3 trial in high-risk MDS. A subsequent partial clinical hold has been placed on
the Phase 2 multiple myeloma study and the fully enrolled Phase 2 DLBCL study.
Importantly, patients currently enrolled in our magrolimab studies can continue
treatment and our compassionate use programs remain open.

We are working with FDA to take a comprehensive look at the safety data, and we will
share the outcome as quickly as we can. In the meantime, we remain committed to the
magrolimab development program and believe that it has the potential to address an
important unmet medical need in these seriously ill patients. As you know, the patients
in our ENHANCE Phase 3 trial have a very high unmet need, with a median overall
survival of only 1 to 3 years on the current standard of care.

Separate and prior to the partial clinical hold, our Phase 1b single arm study in higher
risk MDS no longer has a viable path to submission based on regulatory feedback. As
such, we will remain focused on our Phase 3 ENHANCE study and look forward to
sharing the 1b data at an upcoming scientific meeting.

Next, moving to cell therapy on slide 21, on behalf of Christi and the Kite team, I will
share a brief update on the impressive data Kite presented at ASH last December.
First, as you may recall, in 2020 we shared that Yescarta had a four-year overall
survival rate of 44% in third-line LBCL patients. At ASH in December, we presented
five-year data from ZUMA-1 in third-line LBCL patients showing Yescarta demonstrated
a remarkable and durable 43% overall survival rate, stable since our four-year update.
Additionally, 92% of the patients who remained alive at five years have not needed any
additional cancer treatment since their one-time infusion of Yescarta. It’s truly inspiring
to see this type of durability for CAR T cell therapies.
As announced yesterday, the FDA approved a label update for Yescarta to include use
of prophylactic corticosteroids across all approved indications. Adding prophylactic
steroid use can improve the management of certain side effects without compromising
the activity of Yescarta. For example, the FDA label now shows no grade 3 or greater
cytokine release syndrome events occurred using the Cohort 6 protocol, as compared
to 13% in the original label. This label update complements data published in 2021
showing 68% of patients had no CRS or neurologic events within 72 hours of Yescarta
infusion.

As we look to earlier lines of treatment, the landmark ZUMA-7 trial evaluating Yescarta
in second-line relapsed/refractory LBCL demonstrated a greater than 4-fold increase in
median event free survival, or EFS, compared to standard of care through two years of
follow-up. As you can see on the slide, the EFS curve for Yescarta is compelling. The
sBLA was filed last quarter and we expect an FDA decision by April of this year. In
terms of the first-line LBCL data, Yescarta demonstrated 89% overall response rate in
high-risk patients, and 78% complete response with a median follow-up of 15.9 months.
Given these encouraging data, the Kite team is in discussions with regulatory
authorities on a potential path forward in front line LBCL.

And finally, on slide 22, we highlight key 2022 catalysts across the portfolio, many of
which I have just mentioned. I’d also like to take a moment to highlight the three Arcus
milestones in second half of this year.

Last quarter, Gilead opted in to the three Arcus programs, which added four assets to
our portfolio: domvanalimab, an Fc silent anti-TIGIT antibody; AB308, an Fc active anti-
TIGIT antibody; etrumadenant, an adenosine receptor antagonist; and quemliclustat, a
small molecule CD73 inhibitor. Together with Arcus, we expect to share ARC-7 Phase 2
PFS data in the second half of 2022, which will include data for the zimberelimab
monotherapy, zim and dom doublet, as well as the zim, dom and etruma triplet arm. We
look forward to sharing data when available and are very excited to collaborate more
closely with Arcus to accelerate future development plans.
On slide 23, you can see that Gilead’s portfolio now encompasses 55 clinical stage
programs, nearly doubling since 2019. Given the exciting potential of our portfolio
across virology, oncology, and even early stage inflammation assets, this is just the
beginning. Our teams are committed to advancing the most promising programs that
will help transform patient outcomes, and we look forward to sharing our progress with
you over the coming quarters and years.

With that, I’ll hand it over to Andy.

Andrew Dickinson

Thank you, Merdad, and good afternoon, everyone.

It was a strong close to 2021, driven primarily by strong HIV and Veklury revenue in the
fourth quarter. For the full year, and excluding the impact of the LOEs, HIV grew 4%
year-over-year, driven by the continued outperformance of Biktarvy, which achieved
record U.S. market share of 42%, and sales of $8.6 billion, up 19% from 2020.
Oncology was another highlight from both a pipeline and revenue perspective, with full
year cell therapy sales of $871 million growing 43% from 2020, and Trodelvy sales of
$380 million in its first full year. By 2030, we anticipate our oncology franchise will
represent at least a third of our total revenue.

Before I get into the normal P&L review and 2022 guidance, I want to address the EPS
results for this quarter upfront. Slide 25 highlights two sizeable expenses that occurred
after we gave our last guidance in October. First, and subsequent to the exercise of
Gilead’s opt-in to four Arcus assets in December, our fourth quarter results reflect a net
charge of $625 million, recorded in R&D. This charge reflects our $725 million option
payment recognized in Q4 less $100 million that was previously accrued. This
impacted our EPS by about $0.38 in Q4 and for the full year.

Second, and as part of a legal settlement with ViiV and related parties, we have agreed
to make a one-time $1.25 billion payment, in addition to an ongoing 3% royalty for
future sales of Biktarvy and the bictegravir component of bictegravir-containing
products in the United States. This royalty extends until October 5 of 2027. The $1.25
billion payment is recorded in our fourth quarter results and reflected in our cost of
goods sold.
This charge constituted an approximately 17% impact to gross margin in the fourth
quarter, and it impacted our EPS by $0.80 for Q4 2021 and the full year. Going forward,
we expect the impact of this new royalty to be approximately 1% on our gross margin,
starting in the first quarter of 2022. Excluding these items, and their combined $1.18
impact, our full year non-GAAP EPS would have exceeded the guidance range that we
set back in October, helped by stronger than expected Veklury sales.

Moving back to our quarterly review on slide 26, fourth quarter revenue in our base
business included HIV product sales growth of 7% year-over-year and 8% sequentially.
Veklury sales were higher than expected due to start of the Omicron surge. Non-GAAP
product gross margin was 70.5%, impacted by the legal settlement that I referenced
earlier, and non-GAAP R&D was impacted by the Arcus opt-in, resulting in non-GAAP
EPS of $0.69 per share.

Our non-GAAP effective tax rate for the fourth quarter was 32.2%, reflecting tax
expense related to uncertain tax positions, an increase in valuation allowance, as well
as the impact of discrete tax benefits related to legal settlements with tax authorities in
2020 that did not recur this year.

For the full year, on slide 27, total product sales of $27 billion grew 11% driven by
Veklury. Excluding Veklury, total product sales were roughly flat at $21.4 billion as
growth in Biktarvy and oncology offset the $1.3 billion impact of the Truvada and Atripla
LOEs in the United States.

I touched on the main P&L impacts in the fourth quarter discussion, but will highlight
that our non-GAAP effective tax rate for 2021 was 20.4%, despite the higher effective
tax rate in the fourth quarter.
Moving now to slide 28. Our 2022 guidance assumes that the recent Omicron surge
represents the only major COVID-19 wave for 2022, and that our HIV business will
continue to recover from the pandemic. With that in mind, we expect Product Sales in
the range of $23.8 billion to $24.3 billion. Excluding Veklury, we expect product sales in
the range of $21.8 billion to $22.3 billion, representing growth of 2% to 4% for our base
business year-over-year. Relative to Q1, I’ll remind you to expect HIV revenue to
decline sequentially. This is a normal dynamic for HIV due to inventory and seasonal
pricing impacts, and you’ll recall last year HIV revenue declined 14% sequentially in Q1
‘21 from Q4 of 2020. For Q122, we expect a larger sequential decline, given the
favorable Q4 ‘21 changes to gross to net estimates that Johanna mentioned earlier.
Nonetheless, we expect a strong year overall for our HIV business and continued
growth in the subsequent quarters.

Looking beyond Q1, we expect the impact of the Truvada and Atripla LOEs will be
largely behind us starting in Q2, and we look forward to accelerating growth in our HIV
business during the remainder of the year.

For the full year 2022, we expect Veklury sales of approximately $2 billion. This
assumes, as I previously indicated, that Omicron will represent the only major surge for
the year, with Veklury revenue heavily weighted in the first quarter. That said, the
pandemic continues to be dynamic, and we will update you on our Veklury expectations
on a quarterly basis, consistent with our recent practice.

Moving to the rest of the P&L. We expect our non-GAAP product gross margin to be
approximately 85% to 86%, consistent with our historic guidance and allowing for the
3% royalty associated with the legal settlement.

For non-GAAP operating expenses, we expect R&D to decrease by a mid-single digit

percentage compared to 2021 levels. This decline is driven by the net $625 million
charge related to the Arcus opt-in in the fourth quarter of 2021. Excluding this, we
expect full year R&D expense to increase by a mid-to-high single digit percentage
compared to 2021 levels.
We expect SG&A to be approximately flat on a dollar basis compared to 2021. Our
non-GAAP effective tax rate is expected to be approximately 20% this year. Finally, we
expect our non-GAAP diluted EPS to be between $6.20 and $6.70 for the full-year, and
GAAP diluted EPS to be between $4.70 and $5.20.

On capital allocation, our priorities have not changed. We continued to invest in our
business while, at the same time, we returned over $4 billion in 2021 to our
shareholders, through dividends and share repurchases. In addition, we repaid $4.75
billion of debt in 2021. For 2022, we plan to repay $1.5 billion of debt, of which, we
repaid $500 million this morning.

With that, I will invite the operator to begin the Q&A. Thank you.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Geoff Meacham from
Bank of America.

Geoff Meacham

Dan or Andy, maybe a higher level strategic question. I wanted to ask about your
comments regarding long-term oncology sales. And the question is, are you
comfortable with the aggregate assets in the portfolio? Do you think you’ll need to be
more aggressive on BD either to drive more near-term growth or looking longer term to
have higher impact assets?

Daniel O’Day
Thanks, Jeff. Thanks for the question and teaming. I’ll start and then hand it over to
Andy. So, yes, I mean, the guide that we gave at JP Morgan was that we are confident
in our ability to grow and to also have oncology by 2030 be at least a third of our overall
revenue on top of a solid HIV business and virology business overall. I think, the
answer to the question, Geoff, is we believe we have everything in-house to be able to
fulfill on that commitment today. I mean, the number of options that we have with
Trodelvy, with magrolimab, with the Arcus assets and with Cell Therapy from an
oncology base provides tremendous opportunity for us to look alone and in combination
of that portfolio in the coming years.

And that specifically leads to the more than 30 clinical trials we have ongoing right now
in our oncology portfolio. And our guide that this year will start at least another 20 in the
oncology space. So really, that’s the armamentarium behind our commitment and our
growth. Of course, we’ll continue to be opportunistic around business development and
look for supplemental options out there that can complement this portfolio as a course
of normal business as any healthy company should.

Having said that, we really do have enough in-house to be able to fill up on that
commitment. So, with that, Andy, I may have stolen all your thunder, but I’m sure you’ll
have some additional perspectives.

Andrew Dickinson

Yes. Geoff, thank you for the question. I think it’s an important question, especially in
the context of the magrolimab clinical hold that maybe underpinning the question
specifically. But the answer is relatively simple. We have a very strong set of assets
already. The guidance that we provided at JP Morgan does not actually include all of
the assets or all the indications for all the assets. So, there’s a lot of ways for us to get
there. We have complete confidence in where we’re going, and we don’t expect to
change our BD strategy as a result of any of the recent developments.
We’re actually really excited about where we are. And there’s a lot of upside to that of
other assets, whether it’s some of the earlier Arcus assets or the Tizona or Pionyr
assets, as examples, provide additional options for patients. So, when you talk about
high-impact assets, I would just summarize by saying, we already think that we have a
great portfolio of high-impact assets in oncology, we’re incredibly pleased with what
we’ve put together and nothing that’s happened recently has changed that in any way.
So, thanks for the question.

Operator

Our next question comes from the line of Mohit Bansal from Wells Fargo.

Mohit Bansal

Maybe a question for Merdad. So, in the light of new data that are emerging in HR
positive and HER2-negative breast cancer, do you have any updated thoughts on how
to think about overall survival in the treatment and control arms for TROPiCS-02 vis-à-
vis the expectation or the assumptions in clinical trials, which I think, if I’m not mistaken,
12 months for the control and 16.5 months for the treatment? So, how should we think
about OS? Thank you.

Daniel O’Day

Thanks, Mohit. Directly over to you, Merdad.

Merdad Parsey

Yes. Thanks, Mohit. It’s a great question. And I think as I mentioned in my call, I think
we’re excited that we’re going to be able to share the first interim analysis from the OS
as well when we do the readout here for the PFS. So, I do think we’ll look at both at the
same time. You’re absolutely right that there are developments in the HR-positive
space, but I continue to believe, and I think that the impact on both PFS -- on PFS in
particular here, but also OS continues to be, I think, if we see something in the ballpark
of what you just described, we’re confident that that remains incredibly clinically
relevant for people suffering with HR-positive HER2-negative.

It is, as you state, an increasingly competitive area, but we do think that that remains a
key milestone for patients if we can achieve that.
Operator

Our next question comes from the line of Cory Kasimov from JP Morgan.

Cory Kasimov

I wanted to follow up as well on the TROPiCS-02 study. And maybe, Merdad, can you
talk about how you see the potential significance of this convergence of events that you
alluded to when thinking about both progression-free survival and overall survival? Did
you see any implications from this, or is this kind of moving along the lines as you
would have expected it to?

Merdad Parsey

Yes. Great question, and thanks for asking it. I think I’m very reassured I would not read
anything into this other than the fact that we’ve been, as you can imagine, keeping
track of the PFS events and the OS events all along. And we’ve now gotten to the point
where those OS events have occurred in a time frame that allows us to look at both of
these events at the same time.

I don’t think it really says anything about -- I think what you’re getting at is does it have
any implications for the underlying positive or negative or anything like that. And I really
don’t think there’s any way to interpret that right now. It would be pure speculation to
think that there’s some underlying driver of bringing those endpoints together. And
actually, it’s not that unexpected. It’s a little bit closer than we thought it would be, but
not by that much. So, I wouldn’t read too much into it. I’m just excited we’ll be able to
do it. It will be a more robust look.

And I think as I’ve said before, we think the regulators are going to want to see those
robust looks at the OS to help them with sort of, in a sense, supporting the PFS
endpoint.

Operator

Our next question comes from the line of Brian Abrahams from RBC Capital Markets.

Brian Abrahams
I wanted to better understand the potential signals from magrolimab. I think you guys
have said that you haven’t observed any clear AE trend. I was curious, where is the
disconnect versus what the FDA and investigator concerns are here? And maybe talk a
little bit about the potential path to resolution, what additional safety data would be
needed and your level of confidence you will reach a resolution? Thanks.

Daniel O’Day

That’s great. Thanks, Brian.

Merdad Parsey

Thanks, Cory. Yes. So look, I think the way to think about it is some of -- there have
been a couple of events that the agency wants to make sure that they have a chance to
look at the overall safety profile. I remain blinded to the safety data. So, what is going
on is we are gathering the safety data, and we’re going to share it with the FDA and
with the data monitoring committee. I can tell you that we feel that these are temporary
challenges right now and we’re going to work through resolving it as quickly as
possible. I don’t think these challenges really shake our confidence for the portfolio
overall and our overall strategy hasn’t changed. We’re really committed to the macro
development program, and we think that it really continues to have the potential to
really address -- an important unmet medical need.

The only thing I’d add is, remember, these are very generally pretty sick patients. And
with that underlying illness, I think it’s appropriate to be cautious to make sure that
we’re striking the right balance as we go forward. But we’ll work through it by looking at
the overall safety at the overall safety profile, Brian, and make sure that we are able to
resolve those issues with the FDA.

Daniel O’Day

And Brian, we’ll keep you informed as that evolves. We have obviously a lot of patients
on magrolimab that continue to be served by magrolimab. So, we have a sense of
urgency in working with the agency around this.

Operator

Our next question comes from the line of Salveen Richter from Goldman Sachs.
Salveen Richter

You referred to the Arcus portfolio. Can you just comment on what you’re most excited
about outside of TIGIT and when you might start the triplet study?

Daniel O’Day

Sure. Merdad, why don’t you start on that?

Merdad Parsey

Sure. I think in addition to the TIGIT asset, as you know, the adenosine portfolio, if you
will, the 2 molecules, the 2 inhibitors of adenosine, both in terms of the synthesis
inhibitor, CD73, as well as the receptor blocker are really interesting to us. They’re early
programs, but we think that there is a real potential for those assets to provide
significant upside to treatment, both in terms of where -- in lung cancer, where we think
there’s some -- the trial that’s ongoing that is looking at the addition of adenosine
inhibition to TIGIT plus PD-1 as well as in some of the indications that Arcus is
evaluating with monotherapy in particular, pancreatic cancer.

So, I think for us, there are a number of opportunities there and the broad potential of
adenosine inhibitors to add on to immuno-oncology in general and TIGIT plus PD-1 in
particular really strike us is a really great opportunity that hopefully as the data mature,
we’ll be able to share more and really underpin the optimism we have around where
those programs are headed.

Daniel O’Day

Right. And I think there was a question around when to start the...

Merdad Parsey
And then the triplet study, yes, we’ll -- we haven’t announced that yet. We need to work
through some details. Thanks for reminding me, Dan. We’re working through some
approach. Really, the question here for us is how to go from the doublet, where we’re
really looking at a TIGIT inhibitor being an unapproved agent, right, and then potentially
bringing in a second unapproved agent. So we have to work through in a sense, the
regulatory complications of how we have to sequence and stage those studies to allow
us to assess the contribution of components such that we can move forward
aggressively.

So, we’re working really closely with our adenosine colleague -- our adenosine
colleagues, our Arcus colleagues, and we’ll work through the regulatory pathways to
make sure that we can get to a robust base Phase 3 trials with those. So, as we do so,
we’ll certainly share the timing in the pathway.

Daniel O’Day

And Salveen, the only thing I’d add on top of Merdad’s eloquent response is the
potential to combine this attractive portfolio for markets with other medicines that we
have within Gilead, including Trodelvy and possibly magrolimab and others, so his
combination of having access to a PD-1 2 TIGIT compounds to adenosine combined
with Trodelvy provides a rich opportunity to look at rational-based combinations. And
we’ll be getting more into that as we do a deeper dive in oncology as a starting point in
April. And then obviously, throughout the year, we’ll continue to update you on that. And
it’s one of the major reasons why opting in early was important to us because we can
work really fluidly now across a very rich portfolio. And with the additional expertise and
colleagues from Arcus, it really expands all of our potential and clinical science and
beyond.

Operator

Our next question comes from the line of Michael Yee from Jefferies.

Michael Yee
Maybe back to Merdad on Trodelvy, appreciating that I know there’s a lot of focus on
this interim OS. I would love to give you the opportunity to perhaps frame expectations
at an interim. Interims have different connotations and there’s different interims at
different percent of events that have accrued. So, could you just explain what percent
of events this interim is based on? Do you actually expect to hit stat significant, or do
you just expecting a trend of a few months? Maybe just talk to that a bit, because I
think there’s different implications of just an interim.

Daniel O’Day

Yes. Thanks, Michael. And maybe just a suggestion, as you answer, Michael’s specific
question, it might be helpful for the whole audience to hear again kind of your overall
view of the potential success of this indication.

Merdad Parsey

Yes. Michael, it’s a great question. And I think, thank you for asking it. So, as a
reminder, I think from a PFS standpoint, the primary endpoint of the study, we believe
we’re really well powered to detect a difference there. And as I’ll remind folks, we did
redesign the study a year ago in order to power the study adequately for OS as well.

I would -- I think as excited as I am that we will be able to report out that first interim
analysis, Michael, you’re absolutely right on that. I would not expect statistical
significance at this first interim because it is relatively early in the time frame that we’re
seeing. So, my expectation is that again, pending a positive outcome that we are well
powered to see a PFS improvement at a statistically significant level. And the OS will
be supportive data at that point that will give us directionality as to where we’re headed.
And then hopefully, subsequent to that as the events accrue, we’ll see where we’re
headed with OS and down the road. It’s a great question.

Operator

Our next question comes from the line of Ronny Gal from Bernstein.

Ronny Gal
Switching over to talk a little bit about Yescarta. Can you tell us if there’s already
impact, the use of Yescarta in second line, or is it still ahead of us? And you’ve
mentioned you’re increasing your capacity by 50%. Are you currently capacity-
constrained or demand-constrained? Essentially, will all that demand be used if it
comes on line?

Daniel O’Day

Yes. Thanks, Ronny. And as I turn it over to Christi, let me just say how many patients
we’ve been able to impact with cell therapy in 2021, and that being just the beginning, I
think, of our promise for the future. We certainly invested in the manufacturing capacity
to anticipate demand and success in the second-line, and Christi can go into the details
with you. Christi, over to you.

Christi Shaw

Thanks, Dan. Thanks for the question. Yes, we’re very excited about not only the
second-line, which is the most important to help the most patients, but the continued
success of third line plus with the five-year data that was presented at ASH where year
four, you saw 43% of patients still alive, and at -- 44% of the patients still on life of four
years and 43% at five years, which I think you heard Merdad say. So, based on those
as well as new indications coming out, we’re really seeing an increase in demand.

Our capacity, we’re well positioned. We have the El Segundo manufacturing site here in
California. Amsterdam was approved during COVID and with up to its capacity by the
end of last year. And now, we have the Maryland site, which will be going online in the
first half of this year where you’ll see our automation as well. So, not only increasing
capacity, but also the ability to reduce costs.

So, things are coming along nicely in terms of our ability to deliver, and we still have
that reliability of 97% success when we give the cells back, which is so critically
important to patients. So, not a capacity issue. We had a transparency, a couple of
issues last year where we had a scheduling issue where physicians were asking for the
exact same slot all at the same time. And we quickly addressed that and no longer
have that concern. So, we’re doing well and preparing for, hopefully, what we’ll see is
helping a lot more patients stay live a lot longer.
Daniel O’Day

Thanks so much, Christi. And overall, Ronny, we’re expecting about a 50% increase in
capacity over the course of 2022, so continued investment there.

Operator

Our next question comes from the line of Colin Bristow from UBS.

Colin Bristow

On magrolimab, maybe could you explain why the multiple myeloma and DLBCL trials
were also on hold given they’re not in combination with aza? And then, just somewhat
related to that, the $1.50 in acquisition-related expenses in the ‘22 guide, is there any
component of that, that’s related to the Forty Seven acquisition.

Daniel O’Day

Great. So I’ll have Andy answer the second. Maybe you want to touch base on the first,
Merdad, also telling about the stage of those 2 trials.

Merdad Parsey

Yes, it’s really important to -- I think this may have not been entirely clear. First of all, I
think -- look, I think whenever there’s a safety question, the agency is going to err on
the side of being cautious. And so we’ll work through with them on how to go forward.
And I agree in those studies, we are not combining with azacitidine. So again, I think as
we share the data and the analysis with the agency, hopefully, we can come to
resolution sooner than later.

And it’s important to note that for the multiple myeloma study, we actually hadn’t really
started enrolling patients at that point. So I think that was one consideration. And by
contrast for the DLBCL study, that is completely enrolled. So, the partial hold there
actually doesn’t have much of a practical impact on that study because we’re going to
continue dosing the patients who are already enrolled in that study.
So, I think -- remember that the way it works is maybe the context here, the holds are
placed on an IND, not on a study-by-study basis, generally. So, this was a hold to the
IND. And so, that’s sort of the context to think about it. I’ll hand it off to Andy to answer
the second part of the question.

Andrew Dickinson

I’m not sure that I fully understood the question, but what I can tell you is none of the --
none of the updates that we provided in terms of the onetime fourth quarter expenses
nor none of our 2022 guidance has anything to do with expenses. So you and I can
maybe talk separately to understand what your question is specifically, but there’s
nothing related to or the Forty Seven acquisition that was either part of our fourth
quarter update, year-end update or part of the 2022 guide specifically.

Daniel O’Day

Thanks, Colin. Happy to take that up separately, too.

Operator

Our next question comes from the line of Hartaj Singh from Oppenheimer.

Hartaj Singh

This is just a question on Veklury. You’re starting to get a pretty consistent franchise
there. I mean, unfortunately, COVID-19 is still out there. Various experts have indicated
and even some of the companies we cover, we’re going from a pandemic to an
endemic kind of state over this year into next year. How do we -- how do you think of
Veklury going forward? I know it’s difficult to give guidance there, but you’ve got a year
and a half worth of data underneath your belt. How are you thinking of hospitalizations
going forward, whether that’s through breakthrough infections, or do you see as
unvaccinated individuals get less and less that hospitalization will concomitantly
decrease? Any thoughts there? And then, assuming the oral program gets approved,
how do you see remdesivir IV and then the oral option working together going forward?
And again, thanks for the questions, and a really nice quarter.

Daniel O’Day
Thanks, Hartaj. So, I think Johanna can start with some of the pandemic -- endemic
and then Merdad could also comment a little bit on the forward portfolio. But please,
Johanna, over to you.

Johanna Mercier

Thanks, Hartaj, for the question. Basically, what we’ve seen since the very beginning is
how that Veklury sales truly track to the hospitalizations. And we’ve seen that most
recently again with the Omicron surge. What we did see as well is the fact that --
despite the fact that Omicron seemed to may be less severe impact, unfortunately, the
number of cases were much greater and therefore just the pure absolute numbers of
hospitalizations went up.

And so, we’ve tracked every single time pretty much in line, parallel to the
hospitalization rates. And we assume that will continue. We do think the
hospitalizations will get impacted by some of the oral compounds, even some of the
outpatient use of Veklury, but also neutralizing antibodies as well as the oral treatments
as well like the PI from Pfizer. And so, we do think that will decrease hospitalizations
over time.

The one thing we had assumed maybe about a year ago is we really thought the
vaccination rates would continue to rise and they didn’t. They basically stabilize at
around the 60%, 65% rate. And of course, there are variances across the country. So,
what we’ve seen is the use of different treatments as well as the vaccinations -- the
vaccination rates are really dictating a little bit kind of the hospitalizations and therefore,
the Veklury usage. And yet again, in the December, January time frame, we’ve really
seen Veklury play a critical role here for these hospitalizations, also having to do with
the fact that many of the other previous agents that were on the market were no longer
effective against the Omicron variant. And we haven’t seen any of that. We’ve seen
very strong efficacy with Veklury, which has also helped that.
I think most recently, the outpatient data that’s just come out in addition to the indication
really plays a critical role when there are surges and hospitals are overcapacity, so that
they really can look at outpatient setting with Veklury, and we think that will just kind of
play hand in hand. And I would propose, as I turn it over to Merdad to address the oral
piece of the puzzle, I actually think you need both. I think you need the oral setting, so
more players in the oral setting is critical and you still need hospitalizations because,
unfortunately, as this -- if it does become endemic, I do think you’ll see a steady rate of
hospitalizations as we go through, and that’s where Veklury plays a critical role.
Merdad?

Merdad Parsey

Yes. Thanks. And I guess, I’d make two points. The first is, is very early days with the
oral program. And so, I would keep that in mind. We just started Phase 1. So, a lot of
things can happen. And so I would just keep that in mind. Obviously, if things go well,
we’ll move as aggressively as possible. And I agree with Johanna. I think that there will
always be a role for both oral and IV therapies. There will be a -- what we’re seeing
now, I think, in terms of how folks are approaching it is that as availability of oral
therapies becomes broader, they’re used relatively early in the course of disease.

Many people may progress and/or not get treated early enough and end up in the
hospital. And at that point, I think that’s where that hospitalized or carry hospitalization
more severe disease is where the role of IV therapies is going to come in, Veklury in
particular is going to come in. So, I have too much to add to what Johanna said, but I
do think there’ll be a role for both in the long run.

Daniel O’Day
Hartaj, just to complement what Johanna and Merdad said, I think we clearly see that
as this becomes endemic that there’ll be potentially a need for multiple mechanisms in
the outpatient setting. So, that’s one of the reasons why approaching it from a
preliminary standpoint as well as to a protease standpoint, we think could make sense
over the long term for resistance patterns. And the last thing I’ll say is I think what
we’ve seen this, whether it’s pandemic or endemic, remdesivir is going to firmly trench
now as a standard of care in the hospital setting. And so, as goes hospitalization, so
will go remdesivir over time, and we think that’s going to be an important part of our
ongoing business and our benefit to patients.

Operator

Our next question comes from the line of Carter Gould from Barclays.

Carter Gould

I wanted to come back to Trodelvy but a little bit more from the commercial and
strategic angle and wanted to -- just sort of the decision to triple the sales force at this
point, ahead of TROPiCS-02, is that decision dependent upon positive data from
TROPiCS-02, or could that potentially be revisited, depending on that outcome?

And then, specifically around sort of what you’re seeing in -- with the sales, it seems
like the growth on an absolute basis quarter-on-quarter does seem to be sort of slowing
a bit. Can you maybe just talk about how the real-world duration of use has maybe
evolved, and if that’s sort of in line with what you saw in the studies -- in the pivotal
studies? Thank you.

Daniel O’Day

Thanks, Carter. Right over to Johanna, please.

Johanna Mercier
Sure, Carter. Thanks for the question. Just a couple of things. One is the footprint, the
geographic footprint that we’ve just initiated and that ramp-up and the tripling. It has
really maybe three objectives. One is to further support our initial launches of both
metastatic TNBC triple-negative breast cancer as well as bladder. So, that’s definitely
number one, and that is here and now. the potential to support a potential indication in
HR positive, which is what you were referring to. And the third one is also setting up for
the future success of our total oncology portfolio.

So, assuming positive data, of course, is what we’ve decided to go for, but having said
that, even if that didn’t play out, this is the right team for the future for Gilead Oncology.
So that was the first part of your question.

The second part of your question about the growth slowing, I actually think we’re quite
pleased, actually, as we got into Q4, what we’ve seen is the share really drive up post
NCCN breast guidelines update in September. And so, we had good data point of
share. The last data point we have is October, and that’s the 1 in 4 that you heard me
talk about earlier. And so, that’s doubling from where we were in April. So, we were at
about half of that share in second line. And now we’re at about 24%, 25% share in
second line. So, a real nice growth on that front and definitely more to come. I think
there’s an incredible opportunity for Trodelvy in this patient setting, especially with the
high unmet medical need and the incredible OS data that we have with Trodelvy. So
more to come on that.

Daniel O’Day

Terrific. Thank you so much, Carter. We can take one last question, everybody. Thank
you.

Operator

Thank you. Our last question comes from the line of Matthew Harrison from Morgan
Stanley.

Matthew Harrison
Just one clarification and one question. So, for Merdad, can you just clarify, it was
unclear to me from your comments whether the FDA had asked for the OS data, and
that’s why you were including this interim now for the filing or if that had been your plan
all along. So, if you could just clarify that would be great. And then, second, any
comments you can make specifically around the stocking tailwind as well as the gross
to net tailwind that you have from HIV in the fourth quarter? Thanks.

Daniel O’Day

Thanks a lot, Matthew. We’ll go to Merdad and then Johanna.

Merdad Parsey

Yes, very quickly. I think as I mentioned, we did upsize the study last year for OS
because we’ve always believed, especially in HR-positive that having OS data are
going to be important to support a file. It’s not the primary endpoint, and we think it’s
going to be important supportive data to go. So, that didn’t really have much to do with
this confluence of events here. It’s a fortuitous event in terms of timing here that will
support our data. So hopefully, that answers...

Daniel O’Day

The FDA did not ask for it.

Merdad Parsey

The FDA didn’t specifically ask us for it. No. It’s always -- we’re always going to take a
look at OS with the first PFS data cut at this point in order -- instead of doing a look and
then an interim, we’re just going to do the PFS and the interim at the same time.

Daniel O’Day

Thanks, Matthew. Johanna?

Johanna Mercier
And Matthew, the second part of your question around the Q4 piece of the puzzle. So,
as you well know, right, as you go into Q4, you usually have a bit of a seasonal
inventory build in the subchannel play. And then, of course, that bleeds out in Q1. So,
that’s one piece of the puzzle. In Q1, the other difference is, of course, you increased
your co-pay support, your donut hole coverage and so all those pieces and your payer
mix kind of changes in your first quarter.

Having said that, in addition to that, there was some favorability in Q4 of 2021 from a
gross-to-net standpoint, which will then create an even bigger kind of decline in Q1,
and that’s what we were referring to. So, hopefully, that helps a little bit. It’s a onetime
thing in Q4. And it’s just more around the comparison versus Q1 over Q4 as we get
through the first quarter, and that’s what I was trying to signal.

Daniel O’Day

Great, Matthew. And I just want to, before I turn it over to Jacquie, thank all of you for
joining from our perspective. We are really excited about the build that we’ve had at
Gilead over the past two years and the team and the people that we have on board.
We’ve got a lot to do this year, and we’re really teed up for a good strong year and a
strong decade ahead with this portfolio.

With that, Jacquie, over to you, please.

Jacquie Ross

Thank you, Dan, and thanks to our operator, Gigi, for your help today, and indeed to all
of you for joining us. We appreciate your continued interest in Gilead and hope that you
can join us for our Virology Deep Dive scheduled for Thursday, the 17th of February.
Thank you.

Operator

This concludes today’s conference call. Thank you for participating. You may now
disconnect.

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