8-KRegulation FD

VERTEX PHARMACEUTICALS INC / MA 8-K Report, Regulation FD Disclosure (Feb 12, 2018)

Filed February 12, 2018For Securities:VRTX

Summary

Vertex Pharmaceuticals announced a significant development on February 12, 2018, with the U.S. Food and Drug Administration's (FDA) approval of SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor). This new treatment is approved for cystic fibrosis (CF) patients aged twelve and older who have specific genetic mutations (two copies of the F508del mutation or at least one mutation responsive to tezacaftor/ivacaftor). The company has set a wholesale acquisition cost of $292,000 annually for SYMDEKO in the U.S. Vertex also provided updated financial guidance for the full year 2018, projecting total CF net product revenues between $2.65 billion and $2.80 billion. This growth is expected to be driven by an increased patient base across their CF portfolio, including the U.S. launch of SYMDEKO and wider adoption of ORKAMBI outside the U.S. The company reiterated its previously announced expense guidance for 2018, with combined GAAP R&D and SG&A expenses projected between $1.80 billion and $1.95 billion, and non-GAAP expenses between $1.50 billion and $1.55 billion.

Key Highlights

  • 1FDA approval of SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for a specific subset of cystic fibrosis patients aged 12 and older.
  • 2SYMDEKO™ targets patients with two copies of the F508del mutation or at least one mutation responsive to tezacaftor/ivacaftor.
  • 3Annual wholesale acquisition cost for SYMDEKO™ in the U.S. is set at $292,000.
  • 4Full-year 2018 total CF net product revenue guidance reiterated at $2.65 billion to $2.80 billion.
  • 5Revenue growth expected from increased patient uptake of Vertex's CF medicines, including the U.S. launch of SYMDEKO™ and increased ORKAMBI use internationally.
  • 6Reiteration of 2018 combined GAAP R&D and SG&A expenses guidance ($1.80B - $1.95B) and non-GAAP guidance ($1.50B - $1.55B).

Frequently Asked Questions

SYMDEKO™ is a combination of tezacaftor/ivacaftor and ivacaftor. It was approved by the FDA for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation in their CFTR gene, or at least one mutation that is responsive to tezacaftor/ivacaftor.

Vertex Pharmaceuticals anticipates that SYMDEKO™, along with its existing CF medicines KALYDECO and ORKAMBI, will drive total CF net product revenues to between $2.65 billion and $2.80 billion for the full year 2018. The launch of SYMDEKO™ in the U.S. is a key factor in this revenue growth projection.

The wholesale acquisition cost for SYMDEKO™ in the United States has been established at $292,000 on an annual basis.

Vertex provides financial guidance on both Generally Accepted Accounting Principles (GAAP) and non-GAAP bases. Non-GAAP measures exclude items such as stock-based compensation, business development transaction expenses, and expenses related to variable interest entities, which management believes provide a clearer view of underlying business trends and aid in comparisons with prior periods.