10-QPeriod: Q3 FY2018

VERTEX PHARMACEUTICALS INC / MA Quarterly Report for Q3 Ended Sep 30, 2018

Filed October 25, 2018For Securities:VRTX

Summary

Vertex Pharmaceuticals Inc. reported a strong financial performance for the nine months ended September 30, 2018, with net income attributable to Vertex of $546.4 million, a significant increase from $162.8 million in the same period of 2017. This growth was primarily driven by a substantial increase in product revenues, particularly from their cystic fibrosis (CF) therapies, which rose by 41% to $2.17 billion. The launch of SYMDEKO and continued growth of KALYDECO were key contributors, partially offset by a decline in ORKAMBI revenues as patients transitioned to newer treatments. The company also benefited from a significant decrease in operating costs and expenses, largely due to the absence of one-time charges that impacted the prior year's results, such as the intangible asset impairment and acquisition costs. The company's financial position strengthened, with cash, cash equivalents, and marketable securities increasing to $3.1 billion, and working capital growing to $2.7 billion. Vertex continues to invest heavily in research and development, with a robust pipeline focused on advancing next-generation CFTR corrector compounds and exploring other therapeutic areas. The company is well-positioned to fund its ongoing operations and R&D initiatives, with management expecting current cash flows and existing resources to be sufficient for at least the next twelve months.

Financial Statements
Beta
Revenue$784.53M
Cost of Revenue$111.25M
Gross Profit$673.28M
R&D Expenses$330.51M
SG&A Expenses$137.29M
Operating Expenses$578.89M
Operating Income$205.65M
Interest Expense$18.69M
Net Income$128.75M
EPS (Basic)$0.51
EPS (Diluted)$0.50
Shares Outstanding (Basic)254.91M
Shares Outstanding (Diluted)259.79M

Key Highlights

  • 1Strong revenue growth driven by CF therapies: Total revenues increased by 19% to $2.18 billion for the nine months ended September 30, 2018, primarily due to a 41% surge in product revenues to $2.17 billion, largely from KALYDECO and the newly launched SYMDEKO.
  • 2Improved profitability: Net income attributable to Vertex more than tripled to $546.4 million for the nine months ended September 30, 2018, compared to $162.8 million in the prior year, reflecting strong revenue growth and reduced operating expenses.
  • 3Significant reduction in operating expenses: Total costs and expenses decreased by 9% to $1.67 billion for the nine months ended September 30, 2018, mainly due to the absence of large one-time charges, such as the $255.3 million intangible asset impairment and $160.0 million asset acquisition cost incurred in the prior year.
  • 4Strengthened balance sheet: Cash, cash equivalents, and marketable securities increased by 46% to $3.06 billion as of September 30, 2018, providing ample liquidity.
  • 5Advancement of CF pipeline: Vertex is progressing with Phase 3 trials for next-generation CFTR corrector compounds (VX-659 and VX-445) in triple combination regimens, potentially expanding treatment options to a broader CF patient population.
  • 6Successful product launches and label expansions: The launch of SYMDEKO and recent FDA approvals for KALYDECO and ORKAMBI in younger age groups indicate continued efforts to broaden market access for their CF treatments.
  • 7Strategic investments impact on earnings: The adoption of new accounting guidance resulted in changes in fair value of equity investments being recognized in net income, contributing to the fluctuation in 'Other items, net'.

Frequently Asked Questions

The substantial increase in net income to $546.4 million from $162.8 million in the prior year was primarily driven by a robust 41% increase in product revenues, reaching $2.17 billion, fueled by the launch of SYMDEKO and growth in KALYDECO sales. Additionally, operating costs and expenses decreased by 9%, largely due to the absence of significant one-time charges recorded in the prior year, such as the intangible asset impairment and asset acquisition costs.

KALYDECO and the newly launched SYMDEKO showed strong performance, with KALYDECO revenues increasing and SYMDEKO contributing significantly post-launch. ORKAMBI revenues experienced a decline, which is attributed to patients switching to SYMDEKO. Vertex is also advancing next-generation CFTR corrector compounds (VX-659 and VX-445) in Phase 3 trials, aiming to offer new treatment options for a larger segment of CF patients, potentially including those with F508del/Min mutations. The company expects approval for SYMKEVI in the EU in Q4 2018.

Vertex maintains a strong liquidity position, with cash, cash equivalents, and marketable securities increasing to $3.06 billion as of September 30, 2018, and working capital at $2.7 billion. The company expects its current cash flows from product sales, along with existing cash reserves, to be sufficient to fund operations for at least the next twelve months. Future funding will be supported by ongoing product revenues, potential milestone payments from collaborations, and its existing revolving credit facility.

Vertex adopted new revenue recognition guidance (ASC 606) in early 2018, which impacted revenue recognition for early access programs in France. Additionally, a new standard related to equity investments means that changes in the fair value of equity investments (like their investment in CRISPR) are now recognized in net income, leading to increased volatility in 'Other income (expense), net'.