Gilead Sciences : First Quarter 2025 Summary of Remarks

Published: 2025-04-24 17:08:13 ET GILD

GILD Q125 Summary of Prepared Remarks

($ in millions, except percentages)

Q125

Yr/Yr

Qtr/Qtr

Management Commentary

HIV

$4,587

(16)%

- YoY driven by higher average realized price and

demand.

- QoQ consistent with our guidance, reflects normal

first quarter seasonality, including lower average

realized price and volume following a particularly

strong Q424, as well as Medicare Part D redesign.

- Treatment market continues to grow in-line with

expectations of +2-3% YoY.

- Biktarvy sales of $3.1B, +7% YoY, driven by higher

demand. Biktarvy U.S. market share increased to

51% and remains regimen of choice in G9 markets.

- U.S. PrEP market +16% YoY, driven by broader

Includes Atripla, Biktarvy,

awareness, growing unrestricted access and

Complera/Eviplera, Descovy,

associated pricing favorability, as well as

Emtriva, Genvoya, Odefsey,

contribution from our focused commercial

Stribild, revenue share Symtuza,

execution.

Truvada, Sunlenca and Tybost.

Revenue share Symtuza represents

- Descovy sales of $586M, grew 38% YoY, driven by

Gilead's revenue from cobicistat

higher realized price and higher demand. HIV PrEP

(C), FTC and TAF in Symtuza

(darunavir / C / FTC / TAF), a fixed

represents significant majority of Descovy sales.

dose combination product

Descovy maintains >40% U.S. PrEP market share

commercialized by Janssen

(+>2pp YoY).

Liver Disease

$758

- YoY driven by increased demand across PBC, HBV,

and HDV, partially offset by lower average realized

price for HCV products in U.S.

- QoQ driven by increased demand and inventory

dynamics, partially offset by lower average

realized price.

- In second full quarter, Livdelzi sales were $40M

(vs. $30M in Q424), driven by continued early

momentum in PBC.

- Recently launched Livdelzi in Germany, and expect

to expand into other major European markets in

the coming months.

($ in millions, except percentages)

Q125

Yr/Yr

Qtr/Qtr

Management Commentary (continued)

Oncology

$757

(4)%

(10)%

Cell Therapy

$464

(3)%

(5)%

- YoY and QoQ reflect accelerating headwinds,

notably outside the U.S. and more broadly in

Tecartus.

- Yescarta sales of $386M, +2% YoY, driven by

higher average realized price and increased RoW

demand, partially offset by lower demand in U.S.

- Tecartus sales of $78M, -22% YoY, due to

increased in- and out-of-class competition.

Includes Yescarta and Tecartus

- >29K patients treated to date and >550 ATCs

globally.

Trodelvy

$293

(5)%

(17)%

- YoY driven by inventory dynamics and lower

average realized price, partially offset by higher

demand.

- QoQ reflects inventory dynamics and lower

demand.

- SoC in 2L mTNBC in U.S. and Europe. Stable share

in pre-treated HR+/HER2- mBC.

Other

$209

(7)%

13%

Includes AmBisome, Cayston,

Jyseleca, Letairis, Zydelig

Product sales excluding

$6,311

(12)%

- YoY primarily driven by HIV and Liver disease,

Veklury

partially offset by lower Oncology sales.

- As expected, QoQ decline driven by inventory

dynamics, partially offset by higher sales in Liver

Disease.

Veklury

$302

(45)%

(10)%

- YoY and QoQ reflect lower rates of COVID-19

hospitalizations due to a milder winter season.

- Veklury used in >60% of U.S. hospitalized patients treated for COVID-19. Remains standard-of-care, particularly for patients with renal and hepatic impairment.

Product sales

$6,613

(1)%

(12)%

Royalty, contract and

$54

37%

61%

other

Total revenues

$6,667

(12)%

Q125 Key Portfolio Highlights

Management Commentary

Virology

Lenacapavir

- Submitted NDA, MAA, and EU Medicines 4 all applications for lenacapavir for

PrEP with FDA and EMA. Recently submitted filings in South Africa and Brazil.

- As of 24 April 2025, we have not experienced any disruptions in our

interactions with FDA and continue to expect a regulatory decision for

lenacapavir for PrEP by our PDUFA date of 19 June, 2025.

- Presented 20 abstracts at CROI, including Phase 1 once-yearly lenacapavir for

PrEP and Phase 2 twice-yearly lenacapavir plus two bNAbs for HIV treatment.

Expect to initiate Phase 3 trial for once-yearly lenacapavir for PrEP in 2H25.

- Continue to expect up to 9 new HIV product launches before the end of 2033.

Liver Disease

Livdelzi (U.S.)/Lyvdelzi (EU)

- European Commission granted conditional marketing authorization for Lyvdelzi

for the treatment of PBC.

Oncology

Trodelvy

- Trodelvy + pembrolizumab demonstrated highly statistically significant and

clinically meaningful progression-free survival benefit over standard-of-care in

the Phase 3 ASCENT-04 trial in 1L PD-L1+ (CPS≥10) mTNBC patients.

- The 2030 U.S., U.K, and EU4 total addressable population is estimated ~25K for

1L mTNBC, of which ~40% is PD-L1+ (CPS≥10).

- Detailed ASCENT-04 data expected at future medical congress and engaging

with global regulators as quickly as possible.

- Phase 3 ASCENT-03 update expected later this quarter.

Cell Therapy

- Titles have been announced for ASCO 2025, where we will share an update on

our Phase 1 KITE-363 (CD19/CD20 bicistronic CAR T) and EGFR/IL13Ra2

bicistronic CAR T data in R/R LBCL and glioblastoma, respectively.

- Phase 3 iMMagine-3 protocol amended to include minimal residual disease

negativity as a dual primary endpoint, in addition to progression-free survival.

Q125 Other Commentary

Management Commentary

Macro & Policy

Tariffs & U.S. Footprint

2025 Anticipated Milestones

Program

Trial

Indication

Update

Status

Virology

Lenacapavir

PURPOSE 1 & 2

Q6M LAI HIV PrEP

FDA decision

2H25 (PDUFA: June 19, 2025)

EMA decision

2H25

Q12M Study

Q12M LAI HIV PrEP

Ph3 FPI

2H25

BIC/LEN

ARTISTRY-1

QD Oral HIV Tx

Ph3 update

2H25

GS-1720/GS-4182

WONDERS-1

QW LAO HIV Tx

Ph2 update

1H25

Oncology

Trodelvy

ASCENT-03

1L mTNBC (PD-L1-)

Ph3 update

1H25

ASCENT-04

1L mTNBC (PD-L1+)

Ph3 update

Complete

EVOKE-SCLC

ES-SCLC

Ph3 FPI

Complete

Anito-cel

iMMagine-1

4L+ R/R MM

Ph2 update

2H25

Inflammation

Livdelzi

RESPONSE

PBC

EC decision

Complete

Q125 Balance Sheet and Cash Flow

(in millions)

Q125

Yr/Yr

Qtr/Qtr

Net cash provided by operating activities

$1,757

(21)%

(41)%

Less: Purchases of property, plant and equipment

$(104)

(1)%

(29)%

Free cash flow(1)

$1,653

(22)%

(42)%

Cash, cash equivalents and marketable debt securities

$7,926

68%

(21)%

Debt repaid

$(1,762)

Cash dividends paid

$(1,010)

Share repurchases

$(730)

82%

Q125 Product Sales by Region

(in millions, except percentages)

Q125

Yr/Yr

Qtr/Qtr

Total product sales - U.S.

$4,631

(17)%

Total product sales - Europe

$1,073

(6)%

(7)%

Total product sales - Rest of World

$909

10%

Total product sales

$6,613

(1)%

(12)%

Q125 Non-GAAP Financial Highlights

You are encouraged to review the GAAP reconciliation of the following non-GAAP measures at the end of this summary.

(in millions, except percentages)

Q125

Yr/Yr

Qtr/Qtr

Management Commentary

Cost of goods sold

$961

(1)%

(4)%

Product gross margin

85%

12 bps

-123 bps

- In-line with our FY25 guidance expectations of

85-86%.

Research and

$1,338

(5)%

(17)%

- YoY due to lower clinical manufacturing

development expenses

activities.

- QoQ due to lower development and clinical

manufacturing activities.

Acquired IPR&D

$253

(94)%

- Primarily the LEO Pharma STAT 6 collaboration

expenses(1)(2)

announced in Jan 2025.

Selling, general and

$1,222

(6)%

(34)%

- YoY reflects lower corporate expenses,

administrative expenses

partially offset by incremental selling and

marketing spend in the U.S.

- QoQ due to seasonality of promotional spend

and lower corporate expenses.

Total operating expenses

$2,814

(59)%

(19)%

Operating income

$2,893

(7)%

Operating margin

43.4%

224 bps

- Q125 margin reflects our ongoing commitment

to continued operating expense discipline and

top-quartile margins.

- Compared to -16.7% for Q124. Excluding

CymaBay acquired IPR&D charge, Q124

operating margin would have been ~42%.

Effective tax rate

16.3%

-283 bps

- Slightly below historical average, largely driven

by tax benefits from stock-based

compensation.

Net income attributable

$2,285

(4)%

to Gilead

Diluted earnings (loss)

$1.81

(4)%

- Compared to -$1.32 per share for Q124.

per share attributable to

Excluding expenses related to CymaBay

Gilead

acquisition, Q124 non-GAAP EPS would have

been $1.82.

Shares used in diluted

1,259

earnings (loss) per share

attributable to Gilead

calculation

NM - Not Meaningful

2025 Guidance

You are encouraged to review the GAAP reconciliation of the following non-GAAP measures at the end of this summary.

(in millions, except percentages

FY25

Management Commentary

and per share amounts)

Total product sales

$28.2 billion - $28.6 billion

No change.

Veklury

~ $1.4 billion

- No change. Consistent with approach in FY24, no

update to Veklury guidance until Q325.

No change.

Total product sales

$26.8 billion - $27.2 billion

- No change to FY25 HIV sales guidance; expected

excluding Veklury

to be ~ flat compared to FY24, with demand-

driven growth offset by the impact of Medicare

Part D Redesign.

Non-GAAP

Product gross margin

85.0% - 86.0%

No change.

R&D

~ Flat

No change.

Acquired IPR&D

$0.4 billion

No change.

SG&A

High-single digit % decline

No change.

Operating income

$12.7 billion - $13.2 billion

No change.

Effective tax rate

~ 19%

No change.

Diluted EPS

$7.70 - $8.10

No change.

- Reflects $0.30 adjustment to fair value of equities

GAAP Diluted EPS

$5.65 - $6.05

securities, excluded from non-GAAP EPS.

Was $5.95 - $6.35.

Certain amounts and percentages in this document may not sum or recalculate due to rounding.

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

Three Months Ended

March 31,

(in millions, except per share amounts)

2025

2024

Revenues:

Product sales

6,613

6,647

Royalty, contract and other revenues

Total revenues

6,667

6,686

Costs and expenses:

Cost of goods sold

1,540

1,552

Research and development expenses

1,379

1,520

Acquired in-process research and development expenses

253

4,131

In-process research and development impairments

2,430

Selling, general and administrative expenses

1,258

1,375

Total costs and expenses

4,430

11,008

Operating income (loss)

2,237

(4,322)

Interest expense

260

254

Other (income) expense, net

328

(91)

Income (loss) before income taxes

1,649

(4,486)

Income tax expense (benefit)

334

(315)

Net income (loss)

1,315

(4,170)

Net income attributable to noncontrolling interest

Net income (loss) attributable to Gilead

1,315

(4,170)

Basic earnings (loss) per share attributable to Gilead

1.06

(3.34)

Diluted earnings (loss) per share attributable to Gilead

1.04

(3.34)

Shares used in basic earnings (loss) per share attributable to Gilead calculation

1,246

1,247

Shares used in diluted earnings (loss) per share attributable to Gilead calculation

1,259

1,247

Supplemental Information:

Cash dividends declared per share Product gross margin

Research and development expenses as a % of revenues Selling, general and administrative expenses as a % of revenues Operating margin

Effective tax rate

GILEAD SCIENCES, INC.

TOTAL REVENUE SUMMARY

(unaudited)

Three Months Ended

March 31,

(in millions, except percentages)

2025

2024

Change

Product sales:

HIV

4,587

4,342

Liver Disease

758

737

Oncology

757

789

(4)%

Other

209

224

(7)%

Total product sales excluding Veklury

6,311

6,092

Veklury

302

555

(45)%

Total product sales

6,613

6,647

(1)%

Royalty, contract and other revenues

37%

Total revenues

6,667

6,686

GILEAD SCIENCES, INC.

NON-GAAP FINANCIAL INFORMATION(1)

(unaudited)

Three Months Ended

March 31,

(in millions, except percentages)

2025

2024

Change

Non-GAAP:

Cost of goods sold

961

974

(1)%

Research and development expenses

1,338

1,403

(5)%

Acquired IPR&D expenses(2)

253

4,131

(94)%

Selling, general and administrative expenses

1,222

1,295

(6)%

Other (income) expense, net

(98)

(104)

(6)%

Diluted earnings (loss) per share attributable to Gilead

1.81

(1.32)

Shares used in non-GAAP diluted earnings (loss) per share attributable to Gilead

calculation

1,259

1,247

Product gross margin

85.5 %

85.4 %

12 bps

Research and development expenses as a % of revenues

20.1 %

21.0 %

-91 bps

Selling, general and administrative expenses as a % of revenues

18.3 %

19.4 %

-104 bps

Operating margin

43.4 %

(16.7)%

Effective tax rate

16.3 %

(29.8)%

________________________________

NM - Not Meaningful

GILEAD SCIENCES, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION

(unaudited)

Three Months Ended

(in millions, except percentages and per share amounts)

March 31,

2025

2024

Cost of goods sold reconciliation:

1,540

1,552

GAAP cost of goods sold

Acquisition-related - amortization(1)

(579)

Non-GAAP cost of goods sold

961

974

Product gross margin reconciliation:

76.7 %

76.6 %

GAAP product gross margin

Acquisition-related - amortization(1)

8.8 %

8.7 %

Non-GAAP product gross margin

85.5 %

85.4 %

Research and development expenses reconciliation:

1,379

1,520

GAAP research and development expenses

Acquisition-related - other costs(2)

(2)

(66)

Restructuring

(38)

(50)

Non-GAAP research and development expenses

1,338

1,403

IPR&D impairment reconciliation:

2,430

GAAP IPR&D impairment

IPR&D impairment

(2,430)

Non-GAAP IPR&D impairment

Selling, general and administrative expenses reconciliation:

1,258

1,375

GAAP selling, general and administrative expenses

Acquisition-related - other costs(2)

(67)

Restructuring

(36)

(13)

Non-GAAP selling, general and administrative expenses

1,222

1,295

Operating income (loss) reconciliation:

2,237

(4,322)

GAAP operating income (loss)

Acquisition-related - amortization(1)

579

Acquisition-related - other costs(2)

133

Restructuring

IPR&D impairment

2,430

Non-GAAP operating income (loss)

2,893

(1,117)

Operating margin reconciliation:

33.6 %

(64.6)%

GAAP operating margin

Acquisition-related - amortization(1)

8.7 %

Acquisition-related - other costs(2)

- %

2.0 %

Restructuring

1.1 %

0.9 %

IPR&D impairment

- %

36.3 %

Non-GAAP operating margin

43.4 %

(16.7)%

Other (income) expense, net reconciliation:

GAAP other (income) expense, net

328

(91)

Loss from equity securities, net

(426)

(14)

Non-GAAP other (income) expense, net

(98)

(104)

Income (loss) before income taxes reconciliation:

GAAP income (loss) before income taxes

1,649

(4,486)

Acquisition-related - amortization(1)

579

Acquisition-related - other costs(2)

133

Restructuring

IPR&D impairment

2,430

Loss from equity securities, net

426

Non-GAAP income (loss) before income taxes

2,731

(1,267)

Disclaimer

Gilead Sciences Inc. published this content on April 24, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 24, 2025 at 21:07 UTC.