10-QPeriod: Q1 FY2017

VERTEX PHARMACEUTICALS INC / MA Quarterly Report for Q1 Ended Mar 31, 2017

Filed April 28, 2017For Securities:VRTX

Summary

Vertex Pharmaceuticals Inc. reported a significant turnaround in its financial performance for the first quarter of 2017 compared to the same period in 2016. The company achieved a net income of $247.8 million, a substantial improvement from a net loss of $41.6 million in Q1 2016. This turnaround was driven by a nearly 80% increase in total revenues, reaching $714.7 million, largely fueled by a substantial $232.5 million in collaborative revenues from a new agreement with Merck KGaA, alongside a 22% growth in net product revenues from its key cystic fibrosis (CF) drugs, ORKAMBI and KALYDECO. Key drivers for the revenue growth include strong product sales from ORKAMBI, which increased by 32%, and KALYDECO, up 9%. The company also announced positive Phase 3 clinical trial results for tezacaftor in combination with ivacaftor, paving the way for potential regulatory submissions. Despite increased operating expenses, primarily in research and development and restructuring, Vertex demonstrated robust profitability. The company maintained a healthy liquidity position with over $1.4 billion in cash, cash equivalents, and marketable securities, positioning it well to fund ongoing operations and development programs, including a pending acquisition of CTP-656.

Financial Statements
Beta

Key Highlights

  • 1Reported a significant net income of $247.8 million, a substantial improvement from a net loss of $41.6 million in the prior year's quarter.
  • 2Total revenues surged by 80% year-over-year to $714.7 million, primarily driven by a $232.5 million upfront payment from a new collaboration with Merck KGaA.
  • 3Net product revenues increased by 22% to $480.6 million, with ORKAMBI sales growing 32% to $294.9 million and KALYDECO sales growing 9% to $185.7 million.
  • 4Announced positive Phase 3 clinical trial results for tezacaftor in combination with ivacaftor, with plans to submit regulatory applications in the US and Europe in Q3 2017.
  • 5Operating expenses increased by 8% to $443.9 million, driven by higher R&D and SG&A costs, alongside increased restructuring expenses.
  • 6Maintained strong liquidity with $1.41 billion in cash, cash equivalents, and marketable securities as of March 31, 2017.
  • 7Entered into an asset purchase agreement to acquire CTP-656 from Concert Pharmaceuticals for $160 million, subject to closing conditions.

Frequently Asked Questions

The primary driver for the significant revenue increase was a $232.5 million upfront payment received from Merck KGaA related to a new strategic collaboration and license agreement for four oncology programs. This significantly boosted collaborative revenues.

Sales for ORKAMBI increased by 32% to $294.9 million, and sales for KALYDECO increased by 9% to $185.7 million. These products continue to be major revenue contributors for Vertex.

Vertex reported positive results from two Phase 3 clinical trials for tezacaftor in combination with ivacaftor, showing statistically significant improvements in lung function. The company plans to submit New Drug Applications (NDAs) to the U.S. FDA and Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) in the third quarter of 2017.

Vertex maintained a strong liquidity position with over $1.4 billion in cash, cash equivalents, and marketable securities as of March 31, 2017. The company expects that its existing cash, coupled with product sales, will be sufficient to fund operations for at least the next twelve months. Future capital needs will be met through existing cash flows, potential new collaborations, and possibly debt or equity offerings.