Vertex Reports Second-Quarter 2021 Financial Results

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31/07/2021 13:02
- Product revenues of $1.79 billion, an 18% increase compared to Q2 2020 -

- Company raises full-year 2021 guidance for product revenues to $7.2 to $7.4B -

- Phase 3 study of next-in-class triple combination for CF to begin in the second half of 2021; multiple additional clinical milestones across the pipeline expected in the next 6 to 9 months -

BOSTON--(BUSINESS WIRE)--Jul. 29, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the second quarter ended June 30, 2021 and raised full-year 2021 guidance for product revenues to $7.2 to $7.4B.

"In the second quarter of 2021, we saw continued, significant growth and strong business performance in our cystic fibrosis franchise. We have now secured reimbursement agreements for the triple combination in more than 15 countries outside the U.S. and started expansion into younger age groups with the U.S. approval in patients 6 to 11 years of age last month. With these advancements, we are poised to reach more patients in 2021 than previously forecasted and are therefore raising our 2021 revenue guidance. Looking forward, we continue to see significant growth ahead in CF, with more than 30,000 CF patients who may benefit from the triple combination but who are not yet treated," said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex.

"We also made important progress with our pipeline programs in the first half of this year. Our pipeline programs are advancing quickly, with five programs in mid- or late-stage clinical trials. We continue to see impressive clinical results with CTX001, our most advanced program outside of CF, in which we have now dosed more than 45 patients. Our pre-commercial efforts for this program are underway, as we prepare to serve patients with sickle cell disease and beta thalassemia and address the significant market opportunity. We look forward to multiple R&D milestones and data readouts in the coming 6 to 9 months," said Dr. Kewalramani.

Second-Quarter 2021 Financial Highlights
Three Months Ended June 30, %
2021 2020 Change
(in millions, except per share amounts)
Product revenues, net $ 1,793 $ 1,524 18%

TRIKAFTA/KAFTRIO $ 1,256 $ 918
ORKAMBI $ 221 $ 232

KALYDECO $ 183 $ 203
GAAP operating (loss) income $ (38) $ 718 N/A
Non-GAAP operating income $ 1,029 $ 874 18%
GAAP net income $ 67 $ 837 (92)%
Non-GAAP net income $ 811 $ 687 18%
GAAP net income per share - diluted $ 0.26 $ 3.18 (92)%
Non-GAAP net income per share - diluted $ 3.11 $ 2.61 19%

Product revenues increased 18% compared to the second quarter of 2020, primarily driven by the uptake of KAFTRIO in Europe and continued strong performance of TRIKAFTA in the U.S. Net product revenues in the second quarter of 2021 increased 4% to $1.26 billion in the U.S. and increased 71% to $536 million outside the U.S., compared to the second quarter of 2020.

GAAP net income decreased compared to the second quarter of 2020, primarily due to a $900 million payment in connection with the amendment of Vertex's collaboration with CRISPR Therapeutics that was recorded as a GAAP R&D expense in the second quarter of 2021.

Non-GAAP net income increased compared to the second quarter of 2020, largely driven by strong growth in product revenues.

Cash, cash equivalents and marketable securities were $6.71 billion, an increase of $49 million compared to $6.66 billion as of December 31, 2020, primarily driven by strong operating cash flow from Vertex's revenue growth and profitability, and offset by the $900 million payment to CRISPR and repurchases of our common stock authorized under our 2020 share repurchase program.

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