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.

Frequently Asked Questions

Vertex's primary focus is on developing and commercializing transformative medicines for people with serious diseases, with a strong emphasis on cystic fibrosis (CF). Its key products for CF are KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI.

The triple combination therapies, combining next-generation correctors with tezacaftor and ivacaftor, represent a significant growth opportunity for Vertex. These regimens have the potential to treat approximately 90% of all CF patients, vastly expanding the eligible patient population compared to current treatments. Positive clinical trial data has been reported, and the company is progressing towards regulatory submission, which could substantially increase future revenues.

In 2018, Vertex reported a 22% increase in total revenues to $3.05 billion, largely due to strong performance in its CF product sales, which grew by 40%. Net income increased dramatically to $2.10 billion, primarily driven by a one-time $1.56 billion tax benefit from releasing a valuation allowance. The company also maintained a robust cash position of $3.17 billion.

Beyond cystic fibrosis, Vertex is actively developing drug candidates for other serious diseases. These include treatments for pain (VX-150), sickle cell disease and beta-thalassemia (through a collaboration with CRISPR Therapeutics), and alpha-1 antitrypsin deficiency.