10-KPeriod: FY2013

GILEAD SCIENCES, INC. Annual Report, Year Ended Dec 31, 2013

Filed February 25, 2014For Securities:GILD

Summary

Gilead Sciences, Inc.'s (GILD) 2013 10-K filing highlights a year of significant progress, particularly in its liver diseases and HIV segments. The company achieved FDA approval for Sovaldi (sofosbuvir), a groundbreaking treatment for Hepatitis C (HCV) that offers shorter treatment durations and improved efficacy compared to existing therapies. In HIV, Gilead expanded its single-tablet regimen (STR) offerings with the European launch of Stribild and approvals for its components, Tybost and Vitekta. The company also advanced its pipeline, with over 200 active clinical studies, including more than 60 Phase 3 trials. Financially, total revenues grew 15% to $11.20 billion, driven primarily by a 15% increase in product sales, reaching $10.80 billion. This growth was largely fueled by their antiviral products, especially the single-tablet regimens for HIV, such as Stribild and Complera/Eviplera. R&D expenses increased by 20% to $2.12 billion, reflecting continued investment in pipeline development. While SG&A expenses also rose, net income increased to $3.07 billion, or $1.81 per diluted share, up from $2.59 billion, or $1.64 per diluted share, in the prior year. Gilead also continued its commitment to shareholder returns through its stock repurchase program.

Financial Highlights

57 data points
Beta

Revenue

$11.20B

74.5% Gross Margin

Net Income

$3.08B

27.5% Net Margin

EPS (Diluted)

$1.81

Total Assets

$22.58B

Cash & Equivalents

$2.11B

Free Cash Flow

$2.97B

Financial Statements
Beta
Revenue$11.20B
Cost of Revenue$2.86B
Gross Profit$8.34B
R&D Expenses$2.12B
SG&A Expenses$1.70B
Operating Expenses$6.68B
Operating Income$4.52B
Interest Expense$307.00M
Net Income$3.08B
EPS (Basic)$2.01
EPS (Diluted)$1.81
Shares Outstanding (Basic)1.53B
Shares Outstanding (Diluted)1.70B

Key Highlights

  • 1Received FDA approval for Sovaldi (sofosbuvir), a significant advancement in HCV treatment.
  • 2Expanded HIV treatment options with the European launch of Stribild and approvals for Tybost and Vitekta.
  • 3Total revenues increased by 15% to $11.20 billion, driven by strong antiviral product sales.
  • 4Product sales grew by 15% to $10.80 billion, primarily due to robust HIV STR performance.
  • 5R&D expenses increased by 20% to $2.12 billion, underscoring continued pipeline investment.
  • 6Net income rose to $3.07 billion ($1.81 per diluted share) from $2.59 billion ($1.64 per diluted share) in the prior year.
  • 7Active clinical development pipeline expanded to over 200 studies, with more than 60 in Phase 3.

Frequently Asked Questions

Gilead's revenue growth in 2013 was primarily driven by its antiviral products, particularly its single-tablet regimens (STRs) for HIV, such as Stribild and Complera/Eviplera. The company also saw contributions from its cardiovascular products, Letairis and Ranexa. The recent approval and initial sales of Sovaldi in December 2013 also contributed to revenue.

The FDA approval of Sovaldi (sofosbuvir) in December 2013 marked a significant milestone for Gilead and a major advancement in the treatment of Hepatitis C (HCV). Sovaldi offers a shorter treatment duration (as little as 12 weeks) and reduced or eliminated the need for pegylated interferon injections in certain patient populations, representing a substantial improvement over previous standards of care.

Gilead significantly increased its R&D investment in 2013, with expenses rising 20% to $2.12 billion. This increase reflects the company's ongoing commitment to advancing its robust pipeline, which included over 200 active clinical studies, with more than 60 in Phase 3 trials across key therapeutic areas like oncology, liver diseases, and HIV.

Gilead expects continued product sales growth in 2014, driven by the full-year impact of Sovaldi sales and the ongoing uptake of its HIV products. The company plans to expand its commercial infrastructure, particularly in Europe and Asia, to support Sovaldi launches and the anticipated launch of its oncology product, idelalisib. However, Gilead also anticipates potential headwinds from pricing pressures in Europe, generic competition (e.g., generic efavirenz), foreign currency volatility, and changes in the reimbursement landscape.