Early Access

10-KPeriod: FY2018

VERTEX PHARMACEUTICALS INC / MA Annual Report, Year Ended Dec 31, 2018

Filed February 13, 2019For Securities:VRTX

Summary

Vertex Pharmaceuticals Incorporated's (VRTX) 2018 10-K filing highlights a year of significant growth driven by its cystic fibrosis (CF) franchise. The company's core CF medicines – KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI – are now approved for approximately half of the estimated 75,000 CF patients in North America, Europe, and Australia. A key focus for investors is Vertex's progress in developing next-generation triple combination therapies (VX-659 and VX-445 with tezacaftor and ivacaftor), which have the potential to treat approximately 90% of all CF patients. Positive Phase 3 data for the VX-659 combination was reported, and the company anticipates reporting data for the VX-445 combination in early 2019, with a potential New Drug Application (NDA) submission by mid-2019. Financially, Vertex reported substantial revenue growth, with total revenues increasing by 22% to $3.05 billion. Net income saw a dramatic rise to $2.10 billion, largely influenced by a significant one-time tax benefit from releasing a valuation allowance. The company maintained a strong balance sheet with $3.17 billion in cash, cash equivalents, and marketable securities as of year-end 2018. Beyond CF, Vertex is advancing pipeline programs in pain, sickle cell disease, beta-thalassemia, and alpha-1 antitrypsin deficiency, demonstrating a strategy to diversify its therapeutic focus.

Financial Statements
Beta
Revenue$3.05B
Cost of Revenue$409.54M
Gross Profit$2.64B
R&D Expenses$1.42B
SG&A Expenses$557.62M
Operating Expenses$2.41B
Operating Income$635.15M
Interest Expense$72.47M
Net Income$2.10B
EPS (Basic)$8.24
EPS (Diluted)$8.09
Shares Outstanding (Basic)254.29M
Shares Outstanding (Diluted)259.19M

Key Highlights

  • 1Vertex's CF medicines (KALYDECO, ORKAMBI, SYMDEKO/SYMKEVI) now cover approximately half of the estimated 75,000 CF patients in key markets, with significant revenue growth driven by SYMDEKO/SYMKEVI.
  • 2Positive Phase 3 data for the VX-659 triple combination therapy has been announced, with an anticipated NDA submission for a triple combination regimen by mid-2019.
  • 3Total revenues increased 22% to $3.05 billion in 2018, primarily driven by a 40% increase in CF product revenues.
  • 4Net income surged to $2.10 billion, significantly boosted by a $1.56 billion one-time tax benefit related to the release of a valuation allowance.
  • 5The company ended 2018 with a strong cash position of $3.17 billion, indicating financial flexibility for R&D and business development.
  • 6Vertex is actively expanding its pipeline beyond CF, with promising early-stage development in pain (VX-150), sickle cell disease/beta-thalassemia (CTX001 via collaboration with CRISPR Therapeutics), and alpha-1 antitrypsin deficiency.

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