On October 28, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the third quarter 2020 (Press release, Gilead Sciences, OCT 28, 2020, View Source,Financial%20Results,the%20same%20period%20in%202019. [SID1234569226]).
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"The recent acquisition of Immunomedics has effectively transformed Gilead’s growth story. Building on the foundation of our strong core business, which proved its durability once again this quarter, we have now significant opportunity to drive additional growth at an accelerated pace," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Trodelvy, an approved medicine with extensive potential for patients with a range of tumor types, adds to our growing portfolio of transformational medicines. By following the strategy we laid out at the start of this year, we have significantly improved Gilead’s near and long-term growth potential."
Financial Results
Total revenues for the third quarter 2020 were $6.6 billion, up 17%, compared to $5.6 billion, for the same period in 2019.
Product sales, excluding Veklury (remdesivir), increased 2% year-over-year to $5.6 billion for the third quarter 2020 primarily due to Gilead’s core HIV products driven by higher volume as channel inventory continues to normalize in the United States as well as stronger patient demand. The increase was partially offset by lower sales volume of Truvada (emtricitabine ("FTC") and tenofovir disoproxil fumarate ("TDF"))-based products and lower sales of hepatitis C virus ("HCV") products.
Veklury revenues were $873 million for the third quarter 2020.
GAAP net income and diluted earnings per share for the third quarter 2020 were $360 million and $0.29, respectively, compared to net loss and diluted loss per share of $(1.2) billion and $(0.92), respectively, for the same period in 2019.
GAAP results for the third quarter 2020 included acquired in-process research and development ("IPR&D") charges totaling $1.2 billion related to collaborations and other investments Gilead entered into during the current quarter as well as a $923 million unrealized loss from changes in the fair value of Gilead’s equity investments in Galapagos NV ("Galapagos").
GAAP results for the third quarter 2019 included $4.0 billion acquired IPR&D charges primarily related to Gilead’s global research and development collaboration agreement with Galapagos.
Non-GAAP net income and diluted EPS for the third quarter 2020 were $2.7 billion and $2.11, respectively, compared to $2.1 billion and $1.64, respectively, for the same period in 2019.
As expected, the third quarter 2020 revenues reflect the continued impact from the COVID-19 pandemic on HCV and pre-exposure prophylaxis ("PrEP"). However, Gilead continued to see signs of recovery in Europe and the United States during the third quarter 2020.
(1) Beginning in 2020, Gilead no longer regularly excludes share-based compensation expense from its non-GAAP financial information. To conform to this change, the prior period non-GAAP financial information has been recast to include share-based compensation expense. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 14 – 16.
The following tables summarize significant items that impacted the comparability of GAAP net income (loss) attributable to Gilead and diluted EPS impact for the periods presented:
(1) All items presented were excluded from non-GAAP net income and non-GAAP diluted earnings per share. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 14 – 16.
Total product sales increased 18% to $6.5 billion for the third quarter 2020, compared to $5.5 billion for the same period in 2019, primarily due to sales of Veklury and Gilead’s core HIV products driven by higher volume and stronger patient demand.
For the third quarter 2020, product sales in the United States, Europe and other international locations were $5.1 billion, $877 million and $540 million, respectively. For the third quarter 2019, product sales in the United States, Europe and other international locations were $4.2 billion, $804 million and $513 million, respectively.
The growth of Gilead’s product sales excluding Veklury was primarily due to the following:
Gilead’s core HIV business driven by higher volume as channel inventory continues to normalize in the United States as well as stronger patient demand; and
Continued patient uptake of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg).
The increase was partially offset by:
Lower sales volume of Truvada (FTC/TDF)-based products; and
Lower HCV sales volume due to the COVID-19 pandemic and lower average HCV net selling price.
HIV product sales increased 8% to $4.5 billion for the third quarter 2020, compared to $4.2 billion for the same period in 2019, primarily due to the underlying strength of the HIV franchise. Biktarvy share continues to grow in the United States.
The increase was primarily driven by:
Gilead’s core HIV business driven by higher volume as channel inventory continues to normalize in the United States following the second quarter consumption of the stockpiling from the first quarter 2020 as well as stronger patient demand; and
Continued patient uptake of Biktarvy and growth of Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP ("Descovy for PrEP").
The increase was partially offset by:
Lower sales volume of Truvada (FTC/TDF)-based products. Gilead expects a significant decline in Truvada sales as the first generic version of Truvada became available in the United States on October 2, 2020;
Lower average net selling price, including the effect of unfavorable payer mix; and
Lower PrEP sales volume due to the COVID-19 pandemic.
HCV product sales decreased 31% to $464 million for the third quarter 2020, compared to $674 million for the same period in 2019. The HCV business continues to recover from the delayed patient starts due to the COVID-19 pandemic.
The decrease was primarily due to:
Lower sales volume driven by lower patient starts in the United States and Europe attributable to a decrease in healthcare provider visits and lower screenings due to the COVID-19 pandemic; and
Lower average net selling price.
Sequentially, HCV sales volume increased in Europe due to higher patient starts.
Cell Therapy product sales, which includeYescarta (axicabtagene ciloleucel) and TecartusTM (brexucabtagene autoleucel), increased 25% to $147 million for the third quarter 2020, compared to $118 million for the same period in 2019. The increase was primarily driven by the continued uptake and expansion of Yescarta in Europe. Tecartus was approved by the United States Food and Drug Administration ("FDA") during the third quarter 2020.
Veklury generated $873 million in sales primarily in the United States during the third quarter 2020. Veklury revenue is generated in a highly dynamic and complex global health environment, which continues to evolve. As a result, Veklury revenue is subject to significant volatility and uncertainly.
Other product sales, which include Vemlidy (tenofovir alafenamide 25 mg), Viread (tenofovir disoproxil fumarate 300mg), Letairis (ambrisentan 5 mg and 10 mg), Ranexa (ranolazine 500 mg and 1000 mg), Zydelig (idelalisib 150 mg), AmBisome (amphotericin b liposome for injection 50 mg/vial) and Cayston (aztreonam for inhalation solution 75 mg/vial), decreased 11% to $462 million for the third quarter 2020, compared to $522 million for the same period in 2019, primarily due to the expected declines in sales of Letairis and Ranexa after generic entries in the first half of 2019.
(1) Beginning in the second quarter 2020, Acquired IPR&D expenses were reported separately from R&D expenses in Gilead’s Condensed Consolidated Statements of Operations to provide additional information. Acquired IPR&D expenses reflect IPR&D impairments as well as the initial costs of externally developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront payments related to various collaborations and the initial costs of rights to IPR&D projects. The amounts for prior periods have been reclassified to conform to the current period presentation. Acquired IPR&D expenses have been historically excluded from Gilead’s non-GAAP financial information.
During the third quarter 2020, compared to the same period in 2019:
R&D expenses and non-GAAP R&D expenses increased primarily due to higher clinical trial expenses related to remdesivir and higher investments in oncology programs including magrolimab, partially offset by lower costs as a result of Gilead’s pause or postponement of certain clinical trials due to the COVID-19 pandemic.
Acquired IPR&D expenses of $4.0 billion for the third quarter 2019 were primarily related to Gilead’s global research and development collaboration agreement with Galapagos. Acquired IPR&D expenses of $1.2 billion for the third quarter 2020 were related to collaborations and other investments Gilead entered into during the current quarter, separately with Arcus Biosciences, Inc. ("Arcus"), Pionyr Immunotherapeutics, Inc. ("Pionyr"), Tango Therapeutics ("Tango") and Tizona Therapeutics, Inc. ("Tizona").
SG&A expenses and non-GAAP SG&A expenses for the third quarter 2020 increased primarily due to higher expenses driven by headcount growth, partially offset by lower marketing and other spend due to the COVID-19 pandemic.
During the third quarter 2020, compared to the same period in 2019:
Other income (expense), net decreased primarily due to unfavorable changes in the fair value of Gilead’s equity securities largely driven by a $923 million unrealized loss relating to Gilead’s investments in Galapagos and lower interest income.
Non-GAAP Other income (expense), net decreased by 82% primarily due to lower interest income.
Effective Tax Rate
The GAAP effective tax rate ("ETR") and non-GAAP ETR for the third quarter 2020 were 57.2% and 18.4%, respectively, compared to 22.2% and 22.1% for the same period in 2019, respectively. The year-over-year increase in GAAP ETR is primarily due to the above-mentioned unrealized loss on Gilead’s equity investments in Galapagos, as well as certain third quarter 2020 acquired IPR&D charges that are non-deductible for income tax purposes. The GAAP and non-GAAP ETR for the third quarter 2020 reflects a $91 million net discrete tax benefit related to a settlement with a taxing authority.
Cash, Cash Equivalents and Marketable Debt Securities
As of September 30, 2020, Gilead had $26.0 billion of cash, cash equivalents and marketable debt securities, compared to $25.8 billion as of December 31, 2019. During the third quarter 2020, Gilead generated $2.3 billion in operating cash flow, issued senior unsecured notes in an aggregate principal amount of $7.25 billion, repaid $2.0 billion of debt that matured during the third quarter 2020, utilized $1.0 billion on acquisitions, net of cash acquired (including IPR&D), paid cash dividends of $861 million and utilized $201 million on stock repurchases. In an event subsequent to the third quarter 2020, on October 23, 2020, Gilead completed the acquisition of Immunomedics, Inc ("Immunomedics"), which was financed with the majority of the proceeds from the September 2020 senior unsecured notes offering, an additional $1.0 billion from a new senior unsecured term loan facility and the balance with cash on hand.
Updated Full Year 2020 Guidance
Gilead’s 2020 guidance has been updated to reflect the continued global progression of the COVID-19 pandemic, including infection rates, hospitalization rates and broad commercial availability of Veklury, resulting in a tightening of the estimated revenue range. As mentioned elsewhere, Veklury generates revenue within a highly dynamic and complex global health environment, which continues to evolve.
Outlook
The COVID-19 pandemic continues to impact Gilead’s business and broader market dynamics, including HCV and PrEP market volume. Gilead expects its core business will continue to gradually recover in the fourth quarter 2020 and into the first half of 2021. Gilead expects that the company’s HIV treatment business will continue to remain largely unaffected and that by the first quarter of 2021, patients with HCV will begin to initiate treatment. The acquisition of Immunomedics will immediately contribute to Gilead’s revenue growth and is expected to be neutral to accretive to Gilead’s non-GAAP EPS in 2023 and significantly accretive thereafter. The fundamentals of Gilead’s business and long-term outlook remain strong.
Business Highlights
During the third quarter 2020, Gilead made important strides in advancing work across each of the three long-term ambitions laid out in its corporate strategy: (i) to bring 10+ transformative therapies to patients by 2030; (ii) to be the biotech employer and partner of choice; and (iii) to deliver shareholder value in a sustainable and responsible manner. This progress occurred as Gilead continued efforts to enhance its understanding of remdesivir’s role in treating COVID-19 and rapidly expand access for patients worldwide.
Corporate Development:
Gilead significantly accelerated the buildout of its oncology portfolio and expertise in the third quarter 2020 by announcing the acquisition of Immunomedics. This transaction, Gilead’s thirteenth in oncology in the last two years, brings a foundational product to Gilead’s oncology franchise, broadening and deepening the company’s solid tumor pipeline and building on current marketed products and late-stage clinical candidates for patients with hematologic malignances.
In September, Gilead agreed to acquire Immunomedics for approximately $21 billion. In an event subsequent to the third quarter 2020, in October, Gilead closed the transaction and gained Trodelvy (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate. Trodelvy was granted accelerated approval by FDA in April for the treatment of adult patients with metastatic triple-negative breast cancer ("mTNBC") who have received at least two prior therapies for metastatic disease. Beyond mTNBC, Trodelvy is being studied as a monotherapy and combination agent for additional tumor types, including HR+/HER2- breast cancer, bladder cancer, non-small cell lung cancer and other solid tumors. At the ESMO (Free ESMO Whitepaper) Virtual Congress 2020, Immunomedics presented new data on Trodelvy, including detailed results from the Phase 3 ASCENT study in mTNBC and additional clinical data in bladder cancer and other solid tumors.
In the third quarter 2020, Gilead also entered into several additional agreements to advance its emerging and complementary oncology portfolio:
Gilead completed its transaction with Arcus to enter into a 10-year partnership. Gilead and Arcus will co-develop and co-commercialize next generation cancer immunotherapies, including investigational products that target important mechanisms involved in tumor evasion of the immune system and cell-intrinsic pathways important for cancer growth and metastasis.
Kite Pharma Inc. ("Kite"), a Gilead Company, entered into a two-year research collaboration and license agreement with HiFiBiO Therapeutics ("HiFiBiO"). HiFiBiO will use its proprietary technology platforms to identify novel acute myeloid leukemia ("AML") targets and anti-AML specific antibodies for Kite’s use in cell therapies, and Kite will have an exclusive option to opt in on any targets discovered through the collaboration.
Gilead announced an agreement with Jounce Therapeutics, Inc. ("Jounce") to exclusively license JTX-1811, Jounce’s monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. Jounce will lead development of JTX-1811 through investigational new drug clearance, and thereafter, Gilead will have the sole right to develop the compound. In an event subsequent to the third quarter 2020, in October, this transaction was completed.
Gilead acquired a 49.9% equity interest in Pionyr, as well as an exclusive option to acquire the remainder of Pionyr following the readout of a Phase 1b study of Pionyr’s investigational antibodies, PY314 and PY159, or earlier. Pionyr’s Myeloid Tuning therapies have the potential to treat patients who currently do not benefit from checkpoint inhibitor therapies. PY314 and PY159 are first-in-class antibodies designed to remove or reprogram, respectively, the immune suppressive cells in the tumor microenvironment and thereby enhance anti-tumor immunity.
Gilead acquired a 49.9% equity interest in Tizona, as well as an exclusive option to acquire the remainder of Tizona following the readout of a Phase 1b study of Tizona’s investigational antibody, TTX-080, or earlier. TTX-080 is a potential first-in-class medicine that targets HLA-G, a novel and emerging immune checkpoint expressed across multiple tumor types.
Gilead expanded its multi-year collaboration with Tango. Tango will continue to leverage its proprietary, CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets. The number of targets covered will expand from five to 15.
Remdesivir and Gilead’s Ongoing COVID-19 Pandemic Response:
Ensuring Broader Access to Veklury:
During the third quarter of 2020, additional regulatory authorizations for the treatment of COVID-19 facilitated broader access to Veklury. Additionally, Gilead continued to collaborate with industry partners and thought leaders to support efforts to systematically address the impact of COVID-19 on minority communities and ensure affordable supply of therapy for people worldwide.
In October and July, Veklury became the first approved treatment for COVID-19 in the United States and European Union, respectively. FDA granted full approval to Veklury for the treatment of patients with COVID-19, and the European Commission ("EC") granted conditional Marketing Authorization for the treatment of COVID-19.
As previously discussed in Gilead’s second quarter 2020 earnings press release, Gilead executed process improvements to shorten the manufacturing time and expanded its manufacturing capacity globally to supply remdesivir broadly. As a result, Gilead has been meeting real-time patient demand for Veklury in the United States since the beginning of October and now meets global patient demand for Veklury, even in the event of potential future surges of COVID-19.
In October, Gilead began distributing Veklury in the United States upon conclusion of the previous distribution agreement with the U.S. Federal government. To ensure stable management of drug supply in the near-term, AmerisourceBergen will continue to serve as the sole U.S. distributor of Veklury through the end of 2020 and will sell the product directly to hospitals. This distribution model closely reflects the traditional model hospitals use to procure medicines. Hospitals will control the quantity of Veklury that they order, enabling them to have a predictable supply of Veklury.
In October, Gilead and the EC signed a joint procurement agreement ("JPA") that will enable rapid and equitable access to Veklury. The JPA enables participating countries in the European Union and the European Economic Area and the United Kingdom to purchase Veklury for both real-time patient demand and stockpiling needs, coordinated by the EC. The agreement covers purchases of Veklury for a six-month period and has the option to be extended.
Advancing Remdesivir Clinical Development:
Gilead continues to make rapid progress advancing remdesivir as a treatment for COVID-19. During the third quarter 2020, additional data were released that further enhance the understanding of remdesivir and point to its important role in treating patients with COVID-19, and new clinical trials were initiated to assess remdesivir’s safety and efficacy in additional patient populations.
In July, Gilead presented new data at the 23rd International AIDS Conference, including a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective of a cohort of patients with severe COVID-19. The analysis demonstrated that remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with the standard of care. Separate subgroup analyses from the Phase 3 SIMPLE-severe trial found that traditionally marginalized racial or ethnic groups treated with remdesivir experienced similar clinical outcomes as the overall patient population in the study.
In July, Gilead announced the initiation of a Phase 1a clinical study to evaluate the safety, tolerability and pharmacokinetics of an investigational, inhaled solution of remdesivir in healthy volunteers. Gilead also announced plans for trials using intravenous infusions in outpatient settings such as infusion centers and nursing homes, trials evaluating remdesivir in combination with the JAK inhibitor, baricitinib, and the IL-6 receptor antagonist tocilizumab; and trials including vulnerable patient populations, such as children, pregnant women, and patients with end-stage renal disease.
In October, the New England Journal of Medicine ("NEJM") published the final results from the National Institute of Allergy and Infectious Diseases’ ("NIAID") Phase 3 ACTT-1 trial in adults hospitalized with mild-moderate or severe COVID-19. The final ACTT-1 study results showed that treatment with Veklury resulted in consistent, clinically meaningful improvements across multiple outcome assessments compared with placebo in COVID-19 patients. The final results also demonstrate that treatment with Veklury resulted in a faster time to recovery than previously reported. Overall, treatment with Veklury resulted in five days faster recovery and reduced disease progression compared with placebo. Veklury reduced mortality by 70 percent at day 29 in patients on low-flow oxygen at baseline in a post-hoc analysis.
Other Pipeline Updates:
Viral Diseases:
In July, new data across Gilead’s HIV franchise were presented at the 23rd International AIDS Conference. The presentations included a new clinical study data for a sustained-delivery subcutaneous formulation of Gilead’s novel investigational HIV-1 capsid inhibitor lenacapavir; additional data evaluating the safety and efficacy of Biktarvy as a treatment for HIV in adults aged 65 or older; data from the DISCOVER trial indicating no increase in sexual health risk behavior among those taking Descovy for PrEP or Truvada for PrEP, and an update on Gilead’s cure research strategy through data on dose-dependent immune responses with vesatolimod, an investigational toll-like receptor 7 ("TL7R") agonist.
In August, the China National Medical Products Administration approved a PrEP indication for Truvada. Truvada is the first medicine approved for HIV prevention in China.
In August, new data showcasing the breadth of Gilead’s research in viral hepatitis were presented at the Digital International Liver Congress 2020. The presentations included data reinforcing the effectiveness of Epclusa for HCV in key underserved populations, as well as new data demonstrating the durable renal and bone safety benefit of Vemlidy for hepatitis B virus ("HBV") and supporting the further evaluation of selgantolimod as part of a combination approach to a functional cure for HBV.
In October, new data for Biktarvy were presented at HIV Glasgow 2020. The presentations included long-term study results from multiple switch studies, in which treatment with Biktarvy continued to demonstrate durable efficacy with an established safety profile in a broad range of people living with HIV, as well as data from the observational, real-world, global BICSTaR study, which showed consistent therapeutic effectiveness and long-term safety in real-world practice settings.
Inflammatory Diseases:
In August, new data highlighting Gilead’s research in nonalcoholic steatohepatitis ("NASH") and primary sclerosing cholangitis ("PSC") were presented at the Digital International Liver Congress 2020. The presentations included the full results from the Phase 2 ATLAS study, which demonstrate the potential for combination approaches for the treatment of people with advanced fibrosis due to NASH, as well as new data describing the utility of machine learning approaches to evaluate liver histology, identify histologic features associated with disease progression in NASH and PSC, and assess the impact of treatment with TDF in chronic HBV.
In September, Gilead and Eisai Co., Ltd., announced that the Japanese Ministry of Health, Labour and Welfare granted regulatory approval of Jyseleca (filgotinib 200 mg and 100 mg tablets) for the treatment of rheumatoid arthritis ("RA") in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.
In September, Gilead and Galapagos announced that EC granted marketing authorization for Jyseleca for the treatment of adults with moderate to severe active RA who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs. Under the marketing authorization, Jyseleca may be used as monotherapy or in combination with methotrexate. The EC’s decision follows a positive opinion from the European Medicines Agency’s ("EMA") Committee for Medicine Products for Human Use ("CHMP"), which was announced in July.
In October, Gilead and Galapagos presented new data at the 2020 United European Gastroenterology Week Virtual Meeting, including late-breaking data from the Phase 2b/3 SELECTION trial evaluating filgotinib for the treatment of moderately to severely active ulcerative colitis ("UC"). The data showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58. In addition, significantly more patients achieved six-month corticosteroid-free remission.
Oncology:
In July, FDA granted accelerated approval to Tecartus, the first and only approved chimeric antigen receptor ("CAR") T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
In September, Kite announced the submission of a supplemental Biologics License Application to FDA for Yescarta for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy. If approved, Yescarta would be the first CAR T cell therapy approved for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma.
In September, Gilead announced that FDA granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational, monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome ("MDS"). The Breakthrough Therapy designation was based on positive results from the ongoing Phase 1b study evaluating magrolimab in combination with azacitidine in previously untreated intermediate, high and very high-risk MDS.
In October, Kite announced that the EMA Committee for CHMP has issued a positive opinion on its Marketing Authorization Application for KTE-X19, a CAR T cell therapy, for the treatment of relapsed or refractory mantle cell lymphoma. In recognition of its potential to benefit patients with significant unmet medical need, KTE-X19 was granted Priority Medicines designation by the EMA.
Senior Unsecured Notes Offering: In September, Gilead issued $7.25 billion aggregate principal amount of senior unsecured notes, in an underwritten, registered public offering, consisting of seven tranches.
Term Loan Facility: In an event subsequent to the third quarter of 2020, in October, Gilead entered into a three-year term loan facility credit agreement with a group of institutional lenders and borrowed an aggregate principal amount of $1.0 billion.
Board Appointment: In October 2020, Anthony Welters, who retired in 2016 as Senior Adviser to the Office of the Chief Executive Officer of UnitedHealth Group Inc., joined Gilead’s Board of Directors. With his extensive experience in the health insurance and managed care industry, Mr. Welters will bring important perspective to the Board as Gilead continues its work to deliver transformational medicines to patients.
Non-GAAP Financial Information
The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information excludes acquisition-related expenses including amortization, acquired IPR&D expenses including the initial costs of externally developed IPR&D with no alternative future use, upfront collaboration and licensing expenses and IPR&D impairments, and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation.Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the tables on pages 14 through 16.
Conference Call
At 4:30 p.m. Eastern Time today, Gilead’s management will host a conference call to discuss the company’s third quarter 2020 financial results and will provide a business update. The live webcast of the call can be accessed at Gilead’s Investors page at View Source Please connect to the website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 6986657 to access the call. Telephone replay will be available approximately two hours after the call through 11:59 p.m. Eastern Time, October 30, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 6986657. The webcast will be archived on www.gilead.com for one year.