\nVertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the first quarter ended March 31, 2023 and reiterated full year 2023 financial guidance.<\/p>\n
\n\u201cVertex delivered a strong start to 2023, with outstanding execution across our business. We continue to reach more patients globally with our cystic fibrosis medicines and progress our broad and diverse pipeline, most notably completing the rolling BLA submissions for exa-cel in the U.S.,\u201d said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. \u201cOver the course of this year, we look forward to continuing to expand our leadership in CF; preparing for near-term launches, including exa-cel; and advancing multiple potentially transformative medicines through mid- and late-stage clinical trials.\u201d<\/p>\n
First Quarter 2023 Results<\/span><\/b><\/p>\n P<\/b>roduct revenue <\/b>increased 13% to $2.37 billion compared to the first quarter of 2022, primarily driven by the strong uptake of TRIKAFTA\/KAFTRIO in multiple countries internationally and continued performance of TRIKAFTA in the U.S. Net product revenue in the first quarter of 2023 increased 3% to $1.40 billion in the U.S. and increased 33% to $971 million outside the U.S., compared to the first quarter of 2022.<\/p>\n Combined GAAP and Non-GAAP R&D, Acquired IPR&D and SG&A expenses<\/b> were $1.3 billion and $1.2 billion, respectively, compared to $818 million and $687 million, respectively, in the first quarter of 2022. The increases were due to higher acquired IPR&D expenses, increased investment in support of multiple programs that have advanced in mid- and late-stage clinical development, and the costs to support launches of Vertex’s therapies globally.<\/p>\n GAAP effective tax rate<\/b> was 21.5% compared to 20.2% for the first quarter of 2022.<\/p>\n Non-GAAP effective tax rate<\/b> was 21.3% compared to 21.5% for the first quarter of 2022. Please refer to Note 1 for further details on our GAAP to Non-GAAP tax adjustments.<\/p>\n GAAP and Non-GAAP net income <\/b>decreased by 8% and 12%, respectively, compared to the first quarter of 2022, primarily driven by higher acquired IPR&D expenses, increased investment in our mid- and late-stage clinical pipeline, and the costs to support launches of Vertex\u2019s therapies globally, partially offset by strong revenue growth and increased interest income.<\/p>\n Cash, cash equivalents and total marketable securities<\/b> as of March 31, 2023 were $11.5 billion, compared to $10.9 billion as of December 31, 2022. The increase was primarily driven by strong revenue growth and operating cash flow, partially offset by our upfront payments to Entrada Therapeutics, CRISPR Therapeutics and other collaboration partners, repurchases of our common stock pursuant to our share repurchase program, and income tax payments.<\/p>\n Full Year 2023 Financial Guidance<\/span><\/b><\/p>\n \nVertex today reiterated its full year 2023 financial guidance, including CF product revenue guidance of $9.55 to $9.7 billion. Vertex\u2019s CF product revenue guidance includes expectations in the U.S. for continued performance of TRIKAFTA in ages 6+ and the launch of TRIKAFTA in the 2-5 age group, as well as continued uptake of KAFTRIO\/TRIKAFTA in ages 6+ in countries outside the U.S., including those with recent reimbursement agreements. This guidance includes an approximately 150-basis-point negative impact from changes in foreign currency rates, inclusive of our foreign exchange risk management program.<\/p>\n \nVertex\u2019s financial guidance is summarized below:<\/p>\n \n\u00a0<\/p>\n<\/td>\n Current FY 2023<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n Previous FY 2023<\/b><\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n CF product revenues<\/b><\/p>\n<\/td>\n \nUnchanged<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$9.55 to $9.7 billion<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n Combined GAAP R&D, Acquired IPR&D and SG&A expenses (2)<\/b><\/p>\n<\/td>\n \nUnchanged<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$4.35 to $4.6 billion<\/p>\n<\/td>\n<\/tr>\n Combined Non-GAAP R&D, Acquired IPR&D and SG&A expenses (2)<\/b><\/p>\n<\/td>\n \nUnchanged<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$3.9 to $4.0 billion<\/p>\n<\/td>\n<\/tr>\n Non-GAAP effective tax rate<\/b><\/p>\n<\/td>\n \nUnchanged<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n21% to 22%<\/p>\n<\/td>\n<\/tr>\n<\/table>\n Key Business Highlights<\/span><\/b><\/p>\n Cystic Fibrosis (CF) Marketed Products<\/span><\/i><\/p>\n \nVertex anticipates the number of CF patients taking our medicines will continue to grow, including through new approvals and reimbursement for the treatment of younger patients. Recent progress includes:<\/p>\n Potential Near-Term Launch Opportunities<\/span><\/i><\/p>\n \nVertex is preparing for the following near-term potential new product launches:<\/p>\n R&D Pipeline<\/span><\/i><\/p>\n \nVertex is delivering on a diversified pipeline of potentially transformative small molecule, mRNA, cell and genetic therapies aimed at serious diseases. Recent and anticipated progress for programs in clinical development is summarized below.<\/p>\n Cystic Fibrosis<\/i><\/b><\/p>\n \nVertex continues to pursue next-in-class, small molecule CFTR modulator therapies as well as an mRNA therapy for the approximately 5,000 patients who cannot benefit from CFTR modulators alone.<\/p>\n Beta Thalassemia and Sickle Cell Disease<\/i><\/b><\/p>\n \nExa-cel is a non-viral ex vivo<\/i> CRISPR gene-editing therapy, which is being developed as a potential functional cure for TDT and SCD. Vertex is developing exa-cel in collaboration with CRISPR Therapeutics.<\/p>\n Neuropathic Pain (NaV1.8)<\/i><\/b><\/p>\n \nVertex has discovered multiple selective small molecule inhibitors of NaV1.8 with the objective of creating a new class of pain medicines that have the potential to provide effective pain relief, without the limitations of opioids and other currently available medicines.<\/p>\n APOL1-Mediated Kidney Disease (AMKD)<\/i><\/b><\/p>\n \nVertex has discovered multiple oral, small molecule inhibitors of APOL1 function, pioneering a new class of medicines that target an underlying genetic driver of kidney disease.<\/p>\n Type 1 Diabetes (T1D)<\/i><\/b><\/p>\n \nVertex is evaluating cell therapies using stem-cell derived, fully differentiated, insulin-producing islet cells to replace the endogenous insulin-producing islet cells that are destroyed in people with T1D, with the goal of developing a potential functional cure for this disease. Vertex has three programs that use these fully differentiated cells.<\/p>\n \nIn addition, a Phase 1\/2 study of VCTX-211, a hypoimmune cell program using ViaCyte cells that originated under the CRISPR Therapeutics and ViaCyte collaboration, is active and enrolling patients.<\/p>\n Alpha-1 Antitrypsin Deficiency<\/i><\/b><\/p>\n \nVertex is working to address the underlying genetic cause of alpha-1 antitrypsin (AAT) deficiency by developing novel small molecule correctors of Z-AAT protein folding, with a goal of increasing the secretion of functional AAT into the blood and addressing both the lung and the liver aspects of AAT deficiency.<\/p>\n Additional Earlier Stage R&D Programs<\/i><\/b><\/p>\n \nConsistent with its overall strategy, Vertex takes a portfolio approach to all of its programs, with additional assets in CF, SCD, TDT, pain, AMKD, T1D and AATD in earlier stages of development.<\/p>\n \nVertex is also advancing preclinical assets in new disease areas, such as Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1). Additionally, Vertex is working on preclinical molecules with the potential to expand our leadership in existing disease areas, including assets targeting gentler conditioning for exa-cel and NaV1.7 in pain.<\/p>\n Investments in External Innovation<\/i><\/b><\/p>\n \nConsistent with its strategy to develop transformative medicines for serious diseases, in the first quarter of 2023, Vertex announced a new licensing agreement for the use of CRISPR Therapeutics\u2019 gene editing technology, known as CRISPR\/Cas9, to accelerate the development of Vertex\u2019s hypoimmune cell therapies for T1D. Under this agreement, Vertex made an upfront payment of $100 million to CRISPR in the first quarter of 2023.<\/p>\n \nIn addition, the previously announced global research collaboration with Entrada Therapeutics, focused on therapeutics for DM1, has closed. Under the terms of the agreement, upon closing, Vertex made an upfront payment of approximately $225 million to Entrada, as well as an equity investment of approximately $25 million.<\/p>\n Non-GAAP Financial Measures<\/span><\/b><\/p>\n \nIn this press release, Vertex’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial results and guidance exclude from Vertex’s pre-tax income (i) stock-based compensation expense, (ii) gains or losses related to the fair value of the company’s strategic investments, (iii) increases or decreases in the fair value of contingent consideration, (iv) acquisition-related costs, and (v) other adjustments. The company’s non-GAAP financial results also exclude from its provision for income taxes the estimated tax impact related to its non-GAAP adjustments to pre-tax income described above and certain discrete items. These results should not be viewed as a substitute for the company\u2019s GAAP results and are provided as a complement to results provided in accordance with GAAP. Management believes these non-GAAP financial measures help indicate underlying trends in the company’s business, are important in comparing current results with prior period results and provide additional information regarding the company’s financial position that the company believes is helpful to an understanding of its ongoing business. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, to manage the company’s business and to evaluate its performance. The company\u2019s calculation of non-GAAP financial measures likely differs from the calculations used by other companies. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.<\/p>\n \nThe company provides guidance regarding combined R&D, Acquired IPR&D and SG&A expenses and effective tax rate on a non-GAAP basis. Unless otherwise noted, the guidance regarding combined GAAP and non-GAAP R&D, Acquired IPR&D and SG&A expenses does not include estimates associated with any potential future business development transactions, including collaborations, asset acquisitions and\/or licensing of third-party intellectual property rights. The company does not provide guidance regarding its GAAP effective tax rate because it is unable to forecast with reasonable certainty the impact of excess tax benefits related to stock-based compensation and the possibility of certain discrete items, which could be material.<\/p>\n \n\u00a0<\/p>\n Vertex Pharmaceuticals Incorporated<\/b><\/p>\n Consolidated Statements of Income<\/b><\/p>\n \n(in millions, except per share amounts)(unaudited)<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n Three Months Ended March 31,<\/b><\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2023<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2022<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nProduct revenues, net<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2,374.8<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2,097.5<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nCosts and expenses:<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nCost of sales<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n266.9<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n245.8<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nResearch and development expenses<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n742.6<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n601.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nAcquired in-process research and development expenses<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n347.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n2.0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nSelling, general and administrative expenses<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n241.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n215.2<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nChange in fair value of contingent consideration<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(1.9<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(7.5<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nTotal costs and expenses<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,595.8<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,056.6<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nIncome from operations<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n779.0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,040.9<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nInterest income<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n122.6<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1.6<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nInterest expense<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(11.4<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(14.9<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nOther income (expense), net<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1.3<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(72.8<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nIncome before provision for income taxes<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n891.5<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n954.8<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nProvision for income taxes<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n191.7<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n192.7<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nNet income<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n699.8<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n762.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nNet income per common share:<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nBasic<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2.72<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2.99<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nDiluted<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2.69<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2.96<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nShares used in per share calculations:<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nBasic<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n257.4<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n255.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nDiluted<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n260.3<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n257.9<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0<\/p>\n Vertex Pharmaceuticals Incorporated<\/b><\/p>\n Product Revenues<\/b><\/p>\n \n(in millions)(unaudited)<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n Three Months Ended March 31,<\/b><\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2023<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2022<\/b><\/p>\n<\/td>\n<\/tr>\n \nTRIKAFTA\/KAFTRIO<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2,096.7<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n1,761.6<\/p>\n<\/td>\n<\/tr>\n \nOther CF products<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n278.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n335.9<\/p>\n<\/td>\n<\/tr>\n \nProduct revenues, net<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2,374.8<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2,097.5<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0<\/p>\n Vertex Pharmaceuticals Incorporated<\/b><\/p>\n Reconciliation of GAAP to Non-GAAP Financial Information<\/b><\/p>\n \n(in millions, except percentages)(unaudited)<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n Three Months Ended March 31,<\/b><\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2023<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2022<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n GAAP cost of sales<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n266.9<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n245.8<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nStock-based compensation expense<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(1.9<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(2.2<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n Non-GAAP cost of sales<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n265.0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n243.6<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n GAAP research and development expenses<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n742.6<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n601.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nStock-based compensation expense<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(76.3<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(80.4<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nAcquisition-related costs (3)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(2.8<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(2.8<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n Non-GAAP research and development expenses<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n663.5<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n517.9<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n Acquired in-process research and development expenses<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n347.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2.0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n GAAP selling, general and administrative expenses<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n241.1<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n215.2<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nStock-based compensation expense<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(44.2<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(47.7<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n Non-GAAP selling, general and administrative expenses<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n196.9<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n167.5<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n Combined non-GAAP R&D, Acquired IPR&D and SG&A expenses<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n1,207.5<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n687.4<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n GAAP other income (expense), net<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n1.3<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(72.8<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \n(Increase) decrease in fair value of strategic investments<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(6.4<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n75.6<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n Non-GAAP other (expense) income, net<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(5.1<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n2.8<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n GAAP provision for income taxes<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n191.7<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n192.7<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTax adjustments (1)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n22.7<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n56.2<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n Non-GAAP provision for income taxes<\/b><\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n214.4<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n248.9<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n GAAP effective tax rate<\/b><\/p>\n<\/td>\n \n21.5<\/p>\n<\/td>\n \n%<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n20.2<\/p>\n<\/td>\n \n%<\/p>\n<\/td>\n<\/tr>\n Non-GAAP effective tax rate<\/b><\/p>\n<\/td>\n \n21.3<\/p>\n<\/td>\n \n%<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n21.5<\/p>\n<\/td>\n \n%<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0<\/p>\n\n
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