10-KPeriod: FY2016

GILEAD SCIENCES, INC. Annual Report, Year Ended Dec 31, 2016

Filed February 27, 2017For Securities:GILD

Summary

Gilead Sciences, Inc. reported total revenues of $30.4 billion for the year ended December 31, 2016, a decrease of 7% compared to the prior year, primarily driven by a decline in Hepatitis C (HCV) product sales. Despite this, the company saw growth in its HIV franchise, largely due to the uptake of its new tenofovir alafenamide (TAF)-based regimens. Gilead also made significant progress in its R&D pipeline, advancing multiple candidates across its key therapeutic areas, including HIV, liver diseases, hematology/oncology, and inflammation/respiratory. The company ended 2016 with a strong balance sheet, holding $32.4 billion in cash, cash equivalents, and marketable securities. Gilead continued its commitment to returning capital to shareholders through significant share repurchases totaling $11.0 billion and dividend payments of $2.5 billion. However, the company faces increasing competition in the HCV market and potential headwinds from upcoming generic competition for its TDF-based HIV products. Significant litigation, particularly related to sofosbuvir, also presents a material risk, with potential damages estimated up to $8.5 billion if adverse outcomes are upheld on appeal.

Financial Highlights

56 data points
Beta

Revenue

$30.39B

86.0% Gross Margin

Net Income

$13.50B

44.4% Net Margin

EPS (Diluted)

$9.94

Total Assets

$56.98B

Cash & Equivalents

$8.23B

Free Cash Flow

$17.05B

Financial Statements
Beta
Revenue$30.39B
Cost of Revenue$4.26B
Gross Profit$26.13B
R&D Expenses$5.10B
SG&A Expenses$3.40B
Operating Expenses$12.76B
Operating Income$17.63B
Interest Expense$964.00M
Net Income$13.50B
EPS (Basic)$10.08
EPS (Diluted)$9.94
Shares Outstanding (Basic)1.34B
Shares Outstanding (Diluted)1.36B

Key Highlights

  • 1Total revenues decreased by 7% to $30.4 billion in 2016, primarily due to lower sales of HCV products Harvoni and Sovaldi, although this was partially offset by strong growth in HIV products, notably the TAF-based regimens.
  • 2The company launched new TAF-based HIV regimens (Genvoya, Descovy, Odefsey) and the pan-genotypic HCV treatment Epclusa in 2016, expanding its product portfolio.
  • 3Research and Development (R&D) expenses increased significantly by 69% to $5.1 billion in 2016, driven by clinical study progression, milestone payments, and strategic collaborations like the one with Galapagos for filgotinib.
  • 4Gilead reported strong operating cash flow of $16.7 billion in 2016 and maintained a robust cash position of $32.4 billion.
  • 5The company returned significant capital to shareholders through $11.0 billion in share repurchases and $2.5 billion in dividends paid in 2016.
  • 6The company faces ongoing and substantial legal proceedings, most notably a patent litigation case related to sofosbuvir where a jury awarded $2.54 billion in past damages, with potential total losses estimated between $0 and $8.5 billion if appeals are unsuccessful.
  • 7Gilead anticipates continued revenue pressure in the HCV market due to declining patient starts and increased competition, and expects generic competition for TDF-based products to impact HIV sales in 2017.

Frequently Asked Questions

In 2016, Gilead's primary revenue drivers were its antiviral products, which include HIV and Hepatitis C (HCV) treatments. Antiviral product sales generated $27.7 billion, with HIV and other antivirals contributing $12.9 billion and HCV products contributing $14.8 billion. The company saw growth in its HIV franchise driven by new TAF-based products. However, HCV product sales declined due to lower sales of Harvoni and Sovaldi. Gilead anticipates a decline in HCV revenues in 2017 due to fewer patient starts and increased competition, while expecting continued growth in HIV, albeit with potential impacts from upcoming generic competition for TDF-based products.

Gilead is involved in significant legal proceedings, most notably concerning its hepatitis C drug, Sovaldi. A jury found Gilead willfully infringed a patent owned by Merck's Idenix subsidiary, awarding $2.54 billion in past damages. Gilead estimates a potential total loss range of $0 to $8.5 billion if this verdict is upheld on appeal, which could materially impact its financial results. The company is also facing other patent litigations and investigations that contribute to increased expenses and potential future liabilities.

Gilead significantly increased its R&D expenses by 69% to $5.1 billion in 2016. This increase was driven by the progression of clinical studies, milestone payments, the purchase of an FDA priority review voucher, and upfront costs for collaborations, such as the agreement with Galapagos for filgotinib. The company is focused on advancing its pipeline across key therapeutic areas, including NASH with selonsertib and various inflammatory diseases with filgotinib, and aims to strategically invest in external licensing and acquisition opportunities to further develop its product portfolio.

Gilead ended 2016 with a strong financial position, reporting $32.4 billion in cash, cash equivalents, and marketable securities. The company generated $16.7 billion in operating cash flow in 2016. Gilead's capital allocation strategy includes substantial investments in R&D, significant share repurchases totaling $11.0 billion in 2016, and dividend payments amounting to $2.5 billion in 2016. This demonstrates a commitment to returning value to shareholders while continuing to invest in future growth.