Retinopathy of Prematurity

Potential vadadustat U.S. approval on PDUFA date of March 27, 2024 Strengthened balance sheet with $55.0 million term loan financing and $26.0 million in proceeds from ATM Reported 2023 Auryxia (ferric citrate) net product revenue of $170.3 million CAMBRIDGE, Mass., March 14, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full year ended December 31, 2023 and recent business highlights. Akebia is preparing for a potential launch of vadadustat, which is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of March 27, 2024. "We are eagerly awaiting the PDUFA date for vadadustat, now within weeks, and we believe the progress we have made over the past 12 months has positioned our team to successfully launch vadadustat in the U.S., if approved," said John P. Butler, Chief Executive Officer of Akebia. "A U.S. approval for vadadustat will be transformational for Akebia and a significant step toward our goal of bettering the lives of people impacted by kidney disease. Our team remains dedicated to delivering an innovative oral therapeutic treatment for anemia due to chronic kidney disease for patients on dialysis." Fourth Quarter 2023 and Recent Business Highlights: Appointed Nicholas Grund as Chief Commercial Officer, who brings years of expertise in customer-facing roles to Akebia. Mr. Grund's operational, commercial and strategic leadership experience across renal and specialty markets will be critical as Akebia prepares for the vadadustat launch in the U.S., if approved. Introduced new pipeline programs in acute care settings, potentially for acute kidney injury or acute respiratory distress syndrome (AKB-9090) and retinopathy of prematurity in neonates (AKB-10108). Closed a new debt facility with BlackRock that provides access to up to $55.0 million in borrowing capacity and used the proceeds from the first tranche of $37.0 million to pay down principal outstanding under the then loan agreement with Pharmakon Advisors, LP. The BlackRock debt facility, which closed on January 29, 2024, also extends the interest-only period in the event of vadadustat approval in the U.S. on or prior to June 30, 2024 without requiring any principal repayment until December 31, 2026. Concluded its offering of common stock under its "at-the-market" (ATM) sales agreement. Akebia raised approximately $26.0 million in gross proceeds. Akebia reported fourth quarter 2023 Auryxia® (ferric citrate) net product revenues of $53.2 million and full year 2023 revenues of $170.3 million, within Akebia's 2023 Auryxia net product revenue guidance of $170.0 - $175.0 million. "We are approaching a potential U.S. launch of vadadustat from an extremely strong financial position. We expect Auryxia net product revenue growth in 2024, with a quarterly revenue cadence that is similar to 2023, we executed a term loan with BlackRock and implemented other financial strategies that together we believe will support our business operations for at least two years if vadadustat is approved. As we move forward, we will continue to carefully manage expenses, while investing appropriately for a successful potential launch of vadadustat," Mr. Butler added. Financial Results Revenues: Total revenues were $56.2 million for the fourth quarter of 2023 compared to $55.8 million for the fourth quarter of 2022, and $194.6 million for the full-year 2023 compared to $292.5 million for the full-year 2022. Net product revenues were $53.2 million for the fourth quarter of 2023 compared to $50.3 million for the fourth quarter of 2022, and $170.3 million for the full-year 2023 compared to $176.9 million for the full-year 2022. License, collaboration and other revenues were $3.0 million for the fourth quarter of 2023 compared to $5.5 million for the fourth quarter of 2022, and $24.3 million for the full-year 2023 compared to $115.5 million for the full-year 2022. COGS: Cost of goods sold was $18.7 million for the fourth quarter of 2023 compared to a benefit of $3.4 million for the fourth quarter of 2022, and $74.1 million for the full-year 2023 compared to $85.6 million for the full-year 2022. Akebia continues to record a non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024. R&D Expenses: Research and development expenses were $9.9 million for the fourth quarter of 2023 compared to $32.1 million for the fourth quarter of 2022, and $63.1 million for the full-year 2023 compared to $130.0 million for the full-year 2022. SG&A Expenses: Selling, general and administrative expenses were $25.4 million for the fourth quarter of 2023 compared to $29.9 million for the fourth quarter of 2022, and $100.2 million for the full-year 2023 compared to $138.6 million for the full-year 2022. Net Income / Loss: Net income was $0.6 million for the fourth quarter of 2023 compared to a net loss of $6.1 million for the fourth quarter of 2022, and $51.9 million for the full-year 2023 compared to $94.2 million for the full-year 2022. Cash Position: Cash and cash equivalents as of December 31, 2023, were approximately $42.9 million. Akebia believes its existing cash resources and the cash it expects to generate from product, royalty, supply and license revenues as well as the borrowings and potential future borrowings that are available under the BlackRock debt facility and the working capital liability are sufficient to fund our current operating plan for at least twenty-four months if vadadustat is approved. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at , which does not form a part of this release. About Vadadustat Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is not approved by the U.S. Food and Drug Administration. Vadadustat is approved in Europe and Australia for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis and in Taiwan for the treatment of anemia due to CKD in adult patients on dialysis. In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. IMPORTANT SAFETY INFORMATION FOR VAFSEO (vadadustat) For safety information, view the European Summary of Product Characteristics (SPC/SmPC) for Vafseo® (vadadustat) at , and and will be available via the Australian Therapeutic Goods Administration website. IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate) CONTRAINDICATION AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis. WARNINGS AND PRECAUTIONS Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy. Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children. ADVERSE REACTIONS Most common adverse reactions with AURYXIA were: Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%). SPECIFIC POPULATIONS Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman. To report suspected adverse reactions, contact Akebia Therapeutics at 1-844-445-3799. Please see full Prescribing Information Forward-Looking Statements Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia's financial results for the fourth quarter and full year ended December 31, 2023; the anticipated scheduled PDUFA date for vadadustat and the potential approval of vadadustat; Akebia's ability to enable a successful commercial launch of vadadustat, if approved; statements that a U.S. approval for vadadustat will be transformational for Akebia; Akebia's expectations and beliefs regarding the impact that the BlackRock debt facility will have on Akebia; Akebia's expectations for Auryxia revenue growth in 2024 and assumptions related thereto; Akebia's plans with respect to vadadustat as a treatment of anemia due to chronic kidney disease in patients on dialysis in the U.S.; Akebia's expectations with respect to Akebia's pipeline in acute care settings for acute kidney injury or acute respiratory distress syndrome (AKB-9090) and retinopathy of prematurity in neonates (AKB-10108) and market potential; and Akebia's goals, objectives and expectations with respect to its operating plan, expenses, cash resources and sources of funding for its cash runway, including its belief that its existing cash resources and the cash it expects to generate from product, royalty, supply and license revenues as well as the borrowings and potential future borrowings that are available under the BlackRock debt facility and the working capital liability are sufficient to fund our current operating plan for at least twenty-four months if vadadustat is approved. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings, including the anticipated FDA decision on the NDA for vadadustat and the potential effects of a negative decision on Akebia's cash runway; the potential therapeutic benefits, safety profile, and effectiveness of vadadustat; the results of preclinical and clinical research; the direct or indirect impact of the COVID-19 pandemic on regulators and Akebia's business, operations, and the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates. Akebia Therapeutics Contact Mercedes Carrasco [email protected] SOURCE Akebia Therapeutics, Inc.

Published results show EYLEA HD with extended 12- or 16-week dosing regimens demonstrated non-inferior vision gains to standard of care EYLEA® (aflibercept) Injection 2 mg with fixed 8-week dosing in patients with wAMD and DME in the first year EYLEA HD has shown impressive durable visual improvements and rapid and resilient fluid control with a safety profile comparable to EYLEA Extended dosing intervals with EYLEA HD have the potential to substantially reduce treatment burden for patients EYLEA HD has been approved in multiple countries including the U.S., EU and Japan TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for EYLEA® HD (aflibercept) Injection 8 mg. Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). “The publication of 48-week results from PULSAR and PHOTON in The Lancet are a recognition of the important advancement EYLEA HD has made in retinal care,” said David M. Brown, M.D., FACS, Director of Research at Retina Consultants of Texas and a trial investigator. “Less than a year after its approval, EYLEA HD has already made an impact in the treatment of wet age-related macular degeneration and diabetic macular edema. EYLEA HD has provided disease control for my tough-to-treat cases of diabetic eye disease and allowed both my diabetic and wet age-related macular degeneration patients to enjoy less frequent dosing with a similar safety profile to EYLEA.” PULSAR and PHOTON are two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA. As published in The Lancet, both PULSAR in wAMD (N=1,009) and PHOTON in DME (N=658) met their primary endpoints, with EYLEA HD demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses, compared to an EYLEA 8-week dosing regimen after initial monthly doses (3 in PULSAR and 5 in PHOTON). Furthermore, 79% and 77% of wAMD patients and 91% and 89% of DME patients, who were respectively randomized to 12- and 16-week dosing, maintained these extended dosing intervals through 48 weeks. The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage. In August 2023, EYLEA HD was approved by the U.S. Food and Drug Administration for the treatment of patients with wAMD, DME and diabetic retinopathy (DR) based on the one-year data. Two-year data were presented in 2023 for PULSAR at the EURETINA Congress and for PHOTON at the American Society of Retina Specialists annual meeting. EYLEA HD is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD (known as Eylea 8 mg outside the U.S.). Eylea 8 mg is approved in the European Union, Japan and other countries. Submissions to other regulatory authorities in additional countries have been made. About the EYLEA HD Clinical Trial Program PULSAR in wAMD and PHOTON in DME are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: EYLEA HD every 12 weeks, EYLEA HD every 16 weeks, or EYLEA every 8 weeks. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON. Patients treated with EYLEA HD in both trials had 3 initial monthly doses, and patients treated with EYLEA received 3 initial doses in PULSAR and 5 in PHOTON. In the first year, patients in the EYLEA HD groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the study. Patients in all EYLEA groups maintained a fixed 8-week dosing regimen throughout their participation in the trials. About wAMD and Diabetic Eye DiseasewAMD is a retinal disease that may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. An estimated 1.4 million Americans have wAMD. DR is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as nonproliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and into the vitreous cavity, potentially causing severe vision loss. DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 6 million people have DR without DME. About Ophthalmology at RegeneronAt Regeneron, we relentlessly pursue groundbreaking innovations in eye care science to help maintain the eye health of the millions of Americans impacted by vision-threatening conditions. Over a decade ago, our breakthrough scientific research resulted in the development of EYLEA, a vascular endothelial growth factor (VEGF) inhibitor designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye. EYLEA has since brought fundamental change to the retinal disease treatment landscape and is supported by a robust body of research that includes eight pivotal Phase 3 trials, 11 years of real-world experience, and more than 70 million EYLEA injections globally. Regeneron continues to advance our anti-angiogenesis expertise with new solutions with the aim of offering optimal flexibility for a broad group of patients and eye care professionals. This includes EYLEA HD, which has been developed with the aim of extending the time between injections, while maintaining the vision gains, anatomic benefits and safety previously observed with EYLEA. IMPORTANT SAFETY INFORMATION AND INDICATIONS INDICATIONSEYLEA® HD (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). EYLEA® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg). IMPORTANT SAFETY INFORMATION EYLEA HD and EYLEA are administered by injection into the eye. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept.Injections into the eye with EYLEA HD or EYLEA can result in an infection in the eye, retinal detachment (separation of retina from back of the eye) and, more rarely, serious inflammation of blood vessels in the retina that may include blockage. Call your doctor right away if you or your baby (if being treated with EYLEA for Retinopathy of Prematurity) experience eye pain or redness, light sensitivity, or a change in vision after an injection.In some patients, injections with EYLEA HD or EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.In infants with Retinopathy of Prematurity (ROP), treatment with EYLEA will need extended periods of ROP monitoring.There is a potential but rare risk of serious and sometimes fatal side effects, related to blood clots, leading to heart attack or stroke in patients receiving EYLEA HD or EYLEA.The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, increased pressure in the eye, eye discomfort, pain, or irritation, blurred vision, vitreous (gel-like substance) floaters, vitreous detachment, injury to the outer layer of the eye, and bleeding in the back of the eye.The most common side effects reported in patients receiving EYLEA were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye.The most common side effects reported in pre-term infants with ROP receiving EYLEA were separation of the retina from the back of the eye, increased redness in the eye, and increased pressure in the eye. Side effects that occurred in adults are considered applicable to pre-term infants with ROP, though not all were seen in clinical studies.You may experience temporary visual changes after an EYLEA HD or EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers sufficiently.For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for full Prescribing Information for EYLEA HD and EYLEA. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn. Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA® HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration and diabetic macular edema; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products (such as EYLEA HD) from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) 2 mg Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Contacts:Media RelationsMary HeatherTel: +1 914-847-8650mary.heather@regeneron.comInvestor RelationsMark HudsonTel: +1 914-847-3482mark.hudson@regeneron.com

Fourth Quarter 2023 Highlights: Consolidated revenue was $548.9 million; Healthcare revenue was $339.9 million; Non-healthcare revenue was $209.0 million; GAAP net income per diluted share of $0.63; and Non-GAAP net income per diluted share (updated definition) of $1.25. Full-Year 2023 Highlights: Consolidated revenue was $2,048.1 million; Healthcare revenue was $1,275.5 million; Non-healthcare revenue was $772.6 million. GAAP net income per diluted share of $1.51; and Non-GAAP net income per diluted share (updated definition) of $3.79. IRVINE, Calif.--(BUSINESS WIRE)-- Masimo Corporation (Nasdaq: MASI) today announced its financial results for the fourth quarter and full-year ended December 30, 2023. Fourth Quarter 2023 Results: Consolidated revenue was $548.9 million, comprised of healthcare revenue of $339.9 million and non-healthcare revenue of $209.0 million. Excluding handheld and fingertip pulse oximeters, shipments of noninvasive technology boards and instruments were 58,500. Consolidated GAAP operating income was $44.1 million. Consolidated non-GAAP operating income (prior definition) was $78.6 million. Consolidated non-GAAP operating income (updated definition) was $91.7 million. Consolidated GAAP net income was $34.0 million, or $0.63 per diluted share. Consolidated non-GAAP net income (prior definition) was $56.9 million, or $1.06 per diluted share, and consolidated non-GAAP net income (updated definition) was $66.9 million, or $1.25 per diluted share. Full-Year 2023 Results: Consolidated revenue was $2,048.1 million, consisting of healthcare revenue of $1,275.5 million and non-healthcare revenue of $772.6 million. Excluding handheld and fingertip pulse oximeters, shipments of noninvasive technology boards and instruments were 263,000. Consolidated GAAP operating income was $136.5 million. Consolidated non-GAAP operating income (prior definition) was $269.6 million. Consolidated non-GAAP operating income (updated definition) was $313.0 million. Consolidated GAAP net income was $81.5 million, or $1.51 per diluted share. Consolidated non-GAAP net income (prior definition) was $171.6 million, or $3.17 per diluted share, while consolidated non-GAAP net income (updated definition) was $204.8 million, or $3.79 per diluted share. Joe Kiani, Chairman and Chief Executive Officer of Masimo, said, “We exited 2023 with growing momentum driven by record contract wins for the year in our healthcare business, important FDA clearances for innovative new products and strong growth in our hearables business. Our ability to translate our core technologies into products that deliver better outcomes for consumers, patients, and providers continues to be the engine for our long-term growth across all our businesses. With stabilization of hospital census and operations post pandemic, our healthy contract backlog and our cutting-edge innovations in growing markets, Masimo is well-positioned for 2024.” For additional financial details, please visit the Investor Relations section of the Company’s website at investor.masimo.com to access the fourth quarter 2023 earnings presentation materials. First Quarter 2024 and Updated Full-Year 2024 Financial Guidance The Company provided the following estimates for its first quarter 2024 and full-year 2024 guidance: Q1 2024 Guidance(1) Updated Full-Year 2024 Guidance(1) (in millions, except earnings per diluted share) GAAP Non-GAAP (Updated Definition) Non-GAAP (Prior Definition) GAAP Non-GAAP (Updated Definition) Non-GAAP (Prior Definition) Consolidated revenue $476 to $501 $476 to $501 $476 to $501 $2,045 to $2,165 $2,045 to $2,165 $2,045 to $2,165 Healthcare revenue $331 to $341 $331 to $341 $331 to $341 $1,345 to $1,385 $1,345 to $1,385 $1,345 to $1,385 Non-healthcare revenue $145 to $160 $145 to $160 $145 to $160 $700 to $780 $700 to $780 $700 to $780 Consolidated operating profit $35 to $41 $63 to $69 $55 to $61 $198 to $214 $307 to $322 $275 to $290 Consolidated earnings per diluted share $0.32 to $0.40 $0.67 to $0.74 $0.56 to $0.63 $1.91 to $2.08 $3.44 to $3.60 $3.00 to $3.15 ______________ (1) Updated guidance provided February 27, 2024. Supplementary Non-GAAP Financial Information For additional non-GAAP financial details, please visit the Investor Relations section of the Company’s website at to access Supplementary Financial Information. Non-GAAP Financial Measures The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with U.S. GAAP. The non-GAAP financial measures presented exclude the items described below. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results. Furthermore, management also believes that these items are not indicative of the Company’s on-going operating performance. These non-GAAP financial measures have certain limitations in that they do not reflect all of the costs associated with the operations of the Company’s business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies. The Company has presented the following non-GAAP measures to assist investors in understanding the Company’s net operating results on an on-going basis: (i) constant currency revenue growth percentage, (ii) non-GAAP net income (prior definition and updated definition), (iii) non-GAAP (net income) earnings per diluted share (prior definition and updated definition) and (iv) non-GAAP operating income/margin (prior definition and updated definition). These non-GAAP financial measures may also assist investors in making comparisons of the Company’s operating results with those of other companies. Management believes constant currency product revenue growth, non-GAAP operating income/margin, non-GAAP net income and non-GAAP earnings per diluted share are important measures in the evaluation of the Company’s performance and uses these measures to better understand and evaluate our business. The non-GAAP financial measures reflect adjustments for the following items: Constant currency revenue adjustments Some of our sales agreements with foreign customers provide for payment in currencies other than the U.S. Dollar. These foreign currency revenues, when converted into U.S. Dollars, can vary significantly from period-to-period depending on the average and quarter-end exchange rates during a respective period. We believe that comparing these foreign currency denominated revenues by holding the exchange rates constant with the prior year period is useful to management and investors in evaluating our revenue growth rates on a period-to-period basis. We anticipate that fluctuations in foreign exchange rates and the related constant currency adjustments for calculation of our revenue growth rate will continue to occur in future periods. Acquired tangible asset amortization These transactions represent amortization expense in connection with business or assets acquisitions associated with acquired tangible assets and asset valuation step-ups. Business transition and related costs These transactions represent gains, losses, and other related costs associated with business transition plans. These items may include but are not limited to severance, relocation, consulting, leasehold exit costs, asset impairment, and other related costs to rationalize our operational footprint and optimize business results. Acquired intangible asset amortization These transactions represent amortization expense in connection with business or assets acquisitions associated with acquired intangible assets including, but not limited to customer relationships, intellectual property, trade names and non-competition agreements. Acquisition, integration and related costs These transactions represent gains, losses, and other related costs associated with acquisitions, integrations, investments, divestitures, assets impairments, and in-process research and development. Litigation related expenses and settlements (prior definition) These transactions represent gains, losses, and other related costs associated with certain litigation matters, which can vary in their characteristics, frequency and significance to our operating results. Litigation related expenses and settlements (updated definition) We have been engaged in various legal proceedings against Apple since January 2020, including various proceedings in the federal courts, various proceedings in the U.S. Patent and Trademark Office (the “PTO proceedings”), and a proceeding in the U.S. International Trade Commission (the “ITC proceeding”). Although we previously excluded only expenses relating to the ITC proceeding from the definition of “Litigation related expenses and settlements”, beginning with the first quarter of 2024, we have revised the definition of “Litigation related expenses and settlements” to exclude not only expenses relating to the ITC proceeding, but also all other Apple litigation expenses, including those relating to the federal court proceedings and the PTO proceedings. We believe all of the Apple litigation expenses are unique in nature and not indicative of the Company’s on-going operating performance, and this updated definition will provide more useful information to investors by facilitating period-to-period comparisons of our financial performance that otherwise may be obscured by the significant fluctuations in Apple-related litigation expenses. Other adjustments In the event there are gains, losses and other adjustments which impact period-to-period comparability and do not represent the underlying ongoing results of the business, the Company may choose to exclude these from non-GAAP earnings. Realized and unrealized gains or losses These transactions represent gains, losses, and other related costs associated with foreign currency denominated transactions and investments. Changes in the underlying currency rates relative to the U.S. Dollar may result in realized and unrealized foreign currency gains and losses between the time these receivables and payables arise and the time that they are settled in cash. Unrealized and realized gains and losses on investments may impact the Company’s reported results of operations for a period. These items are highly variable, difficult to predict and outside the control of those responsible for the underlying operations of the business. Other items also included here are mark-to-market gains and losses of derivative contracts that are not designated as hedging instruments or the ineffective portions of cash flow hedges. Financing related adjustments The Company may enter into various financial arrangements whereby costs are incurred and certain instrument features are valued and expensed accordingly but are not necessarily indicative of the on-going cash flow generation of the Company and therefore excludes these costs from non-GAAP earnings. For GAAP earnings per diluted share purposes, the Company cannot reflect the anti-dilutive impact, if applicable, in its diluted shares calculations. However, the Company believes that reflecting the anti-dilutive impact of these instruments in non-GAAP earnings per diluted share provides management and investors with useful information in evaluating the financial performance of the Company on a per share basis. Tax impact of non-GAAP adjustments In order to reflect the tax effected impact of the non-GAAP adjustments, the Company will adjust the non-GAAP earnings by the approximate tax impact of these adjustments. Excess tax benefits from stock-based compensation expense GAAP requires that excess tax benefits recognized on stock-based compensation expense be reflected in our provision for income taxes rather than paid-in capital. As these excess tax benefits may be highly variable from period-to-period, the Company may choose to exclude these tax benefits from non-GAAP earnings to facilitate comparability between periods and with peers. Fourth Quarter and Full-Year 2023 Actuals versus Fourth Quarter and Full-Year 2022 Actuals: RECONCILIATION OF HEALTHCARE GAAP TO NON-GAAP CONSTANT CURRENCY REVENUE(1): Three Months Ended (in millions, except percentages) December 30, 2023 December 31, 2022 GAAP healthcare revenue $ 339.9 $ 351.9 Constant currency revenue adjustments (1.1 ) N/A Non-GAAP healthcare constant currency revenue $ 338.8 $ 351.9 GAAP healthcare revenue growth percentage (3.4 )% Non-GAAP healthcare constant currency revenue growth percentage (3.7 )% __________________ (1) May not foot due to rounding. RECONCILIATION OF NON-HEALTHCARE GAAP TO NON-GAAP CONSTANT CURRENCY REVENUE(1): Three Months Ended (in millions, except percentages) December 30, 2023 December 31, 2022 GAAP non-healthcare revenue $ 209.0 $ 265.1 Constant currency revenue adjustments (3.6 ) N/A Non-GAAP non-healthcare constant currency revenue $ 205.4 $ 265.1 GAAP non-healthcare revenue growth percentage (21.2 )% Non-GAAP non-healthcare constant currency revenue growth percentage (22.5 )% __________________ (1) May not foot due to rounding. RECONCILIATION OF HEALTHCARE GAAP TO NON-GAAP CONSTANT CURRENCY REVENUE(1): Twelve Months Ended (in millions, except percentages) December 30, 2023 December 31, 2022 GAAP healthcare revenue $ 1,275.5 $ 1,340.3 Constant currency revenue adjustments 5.8 N/A Non-GAAP healthcare constant currency revenue $ 1,281.3 $ 1,340.3 GAAP healthcare revenue growth percentage (4.8 )% Non-GAAP healthcare constant currency revenue growth percentage (4.4 )% __________________ (1) May not foot due to rounding. RECONCILIATION OF GAAP TO NON-GAAP CONSOLIDATED OPERATING INCOME(1): Three Months Ended (in millions) December 30, 2023 December 31, 2022 GAAP operating income $ 44.1 $ 73.5 Non-GAAP adjustments: Acquired tangible asset amortization 0.9 2.4 Acquired intangible asset amortization 9.1 10.1 Acquisition, integration and related costs 5.1 5.8 Business transition and related costs 9.7 — Litigation related expenses, settlements and awards 9.9 12.6 Total non-GAAP adjustments 34.7 30.9 Non-GAAP operating income (prior definition) $ 78.6 $ 104.4 Litigation related expenses and settlements 13.1 7.1 Non-GAAP operating income (updated definition) $ 91.7 $ 111.6 __________________ (1) May not foot due to rounding. RECONCILIATION OF GAAP TO NON-GAAP CONSOLIDATED OPERATING INCOME(1): Twelve Months Ended (in millions) December 30, 2023 December 31, 2022 GAAP operating income $ 136.5 $ 210.0 Non-GAAP adjustments: Acquired tangible asset amortization 5.0 59.4 Acquired intangible asset amortization 38.1 25.5 Acquisition, integration and related costs 23.5 38.4 Business transition and related costs 13.9 — Litigation related expenses, settlements and awards 48.4 28.7 Other adjustments 3.9 — Total non-GAAP adjustments 132.8 152.0 Non-GAAP operating income (prior definition) $ 269.6 $ 362.2 Litigation related expenses and settlements 43.4 20.3 Non-GAAP operating income (updated definition) $ 313.0 $ 382.5 _________________ (1) May not foot due to rounding. RECONCILIATION OF GAAP TO NON-GAAP NET INCOME AND NET INCOME PER DILUTED SHARE(1): Three Months Ended December 30, 2023 December 31, 2022 (in millions, except per diluted share amounts) $ Per Diluted Share $ Per Diluted Share GAAP net income $ 34.0 $ 0.63 $ 41.1 $ 0.76 Non-GAAP adjustments: Acquired tangible asset amortization 0.9 0.02 2.4 0.04 Acquired intangible asset amortization 9.1 0.17 10.1 0.19 Acquisition, integration and related costs 5.1 0.09 5.8 0.11 Business transition and related costs 9.7 0.18 — — Litigation related expenses, settlements and awards 9.9 0.18 12.6 0.23 Realized and unrealized gains or losses 8.0 0.15 7.3 0.14 Financing related adjustments 0.5 0.01 0.5 0.01 Tax impact of non-GAAP adjustments (12.0 ) (0.22 ) (8.2 ) (0.15 ) Excess tax benefits from stock-based compensation expense 0.2 — (0.2 ) — Tax Related Adjustments (8.2 ) (0.15 ) — — Total non-GAAP adjustments 23.1 0.43 30.3 0.56 Non-GAAP net income (prior definition) $ 56.9 $ 1.06 $ 71.3 $ 1.32 Litigation related expenses and settlements 13.1 0.24 7.1 0.13 Tax impact of non-GAAP adjustments (3.1 ) (0.06 ) (1.7 ) (0.03 ) Non-GAAP net income (updated definition) $ 66.9 $ 1.25 $ 76.8 $ 1.42 Weighted average shares outstanding-diluted 53.7 54.1 __________________ (1) May not foot due to rounding. RECONCILIATION OF GAAP TO NON-GAAP NET INCOME AND NET INCOME PER DILUTED SHARE(1): Twelve Months Ended December 30, 2023 December 31, 2022 (in millions, except per diluted share amounts) $ Per Diluted Share $ Per Diluted Share GAAP net income $ 81.5 $ 1.51 $ 143.5 $ 2.60 Non-GAAP adjustments: Acquired tangible asset amortization 5.0 0.09 59.4 1.08 Acquired intangible asset amortization 38.1 0.70 25.5 0.46 Acquisition, integration and related costs 23.5 0.44 38.4 0.70 Business transition and related costs 13.9 0.26 — — Litigation related expenses, settlements and awards 48.4 0.89 28.7 0.52 Other adjustments 3.9 0.07 (0.9 ) (0.02 ) Realized and unrealized gains or losses 1.2 0.02 (5.5 ) (0.10 ) Financing related adjustments 1.9 0.03 1.5 0.03 Tax impact of non-GAAP adjustments (34.8 ) (0.64 ) (35.2 ) (0.64 ) Excess tax benefits from stock-based compensation expense (2.9 ) (0.05 ) (2.4 ) (0.04 ) Tax Related Adjustments (8.2 ) (0.15 ) — — Total non-GAAP adjustments 90.0 1.66 109.4 1.98 Non-GAAP net income (prior definition) $ 171.6 $ 3.17 $ 253.2 $ 4.59 Litigation related expenses and settlements 43.4 0.80 20.3 0.37 Tax impact of non-GAAP adjustments (10.3 ) (0.19 ) (4.8 ) (0.09 ) Non-GAAP net income (updated definition) $ 204.8 $ 3.79 $ 268.7 $ 4.87 Weighted average shares outstanding-diluted 54.1 55.2 __________________ (1) May not foot due to rounding. First Quarter 2024 and Full-Year 2024 Financial Guidance: RECONCILIATION OF GAAP TO NON-GAAP CONSOLIDATED OPERATING INCOME(1): (in millions) Q1 2024 Guidance(2) Updated Full-Year 2024 Guidance(2) GAAP operating income $35 to $41 $198 to $214 Non-GAAP adjustments: Acquired tangible asset amortization 2 6 Acquired intangible asset amortization 9 37 Acquisition, integration and related costs 2 7 Business transition and related costs 4 11 Litigation related expenses, settlements and awards 2 14 Total non-GAAP adjustments 20 75 Non-GAAP operating income (prior definition) $55 to $61 $275 to $290 Litigation related expenses and settlements 8 32 Non-GAAP operating income (updated definition) $63 to $69 $307 to $322 __________________ (1) May not foot due to rounding. (2) Updated guidance provided on February 27, 2024. RECONCILIATION OF GAAP TO NON-GAAP NET INCOME AND NET INCOME PER DILUTED SHARE(1): Q1 2024 Guidance(2) Updated Full-Year 2024 Guidance(2) (in millions, except per diluted share amounts) $ Per Diluted Share $ Per Diluted Share GAAP net income $18 to $22 $0.32 to $0.40 $105 to $115 $1.91 to $2.08 Non-GAAP adjustments: Acquired tangible asset amortization 2 0.03 6 0.12 Acquired intangible asset amortization 9 0.17 37 0.68 Acquisition, integration and related costs 2 0.04 7 0.12 Business transition and related costs 4 0.07 11 0.20 Litigation related expenses, settlements and awards 2 0.04 14 0.25 Financing related adjustments 0 0.01 2 0.03 Tax impact of non-GAAP adjustments (7 ) (0.13) to (0.14 ) (16) to (17 ) (0.30) to (0.31 ) Excess tax benefits from stock-based compensation expense (0 ) (0.01 ) (2 ) (0.03 ) Total non-GAAP adjustments 13 0.22 59 1.06 Non-GAAP net income (prior definition) $30 to $34 $0.56 to $0.63 $165 to $174 $3.00 to $3.15 Litigation related expenses and settlements 8 0.15 32 0.58 Tax impact of non-GAAP Adjustments (2 ) (0.03 ) (8 ) (0.14 ) Non-GAAP net income (Updated definition) $37 to $40 $0.67 to $0.74 $189 to $198 $3.44 to $3.60 Weighted average shares outstanding-diluted 54.6 55.1 __________________ (1) May not foot due to rounding. (2) Updated guidance provided on February 27, 2024. Conference Call: The conference call to review Masimo’s complete financial results for the fourth quarter and full-year ended December 30, 2023 will begin at 1:30 p.m. PT (4:30 p.m. ET) on February 27, 2024 and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Micah Young, Executive Vice President and Chief Financial Officer. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at . To register for the conference call and receive the dial-in number, please use the link below. Upon registering, each participant will be provided with call details and a registrant ID number. Conference Call Registration Link: A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the Company’s website. About Masimo Masimo (Nasdaq: MASI) is a global technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins®, Denon®, Marantz®, and Polk Audio®. Our mission is to improve life, improve patient outcomes and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates, improve CCHD screening in newborns, and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs. Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world, and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7®, Radius PPG® and Radius VSM™, portable devices like Rad-67®, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, iSirona™, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Its growing portfolio of health and wellness solutions includes Radius T® and Masimo W1™ watch. Additional information about Masimo and its products may be found at . Published clinical studies on Masimo products can be found at . RPVi has not received FDA 510(k) clearance and is not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. Forward-Looking Statements All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements including, in particular, the statements about our expectations for full-year 2023 financial guidance; the interest in our W1™ watch and upcoming innovations; our long-term outlook; demand for our products; anticipated revenue and earnings growth; our financial condition, results of operations and business generally; expectations regarding our ability to design and deliver innovative new noninvasive technologies and reduce the cost of care; our ability to address supply chain challenges; anticipated benefits from our acquisition of Sound United; and demand for our products and technologies; including with respect to revenue, revenue growth and constant currency revenue growth, gross margin, operating margin, GAAP earnings per diluted share, non-GAAP earnings per diluted share, estimated tax rate and year-over-year currency headwinds; our long-term outlook; our ability to continue in our leadership in delivering innovative solutions to clinicians and patients worldwide; anticipated revenue and earnings growth. These forward-looking statements are based on management’s current expectations and beliefs and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control and could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our dependence on Masimo SET® and Masimo rainbow SET™ products and technologies for substantially all of our revenue; any failure in protecting our intellectual property exposure to competitors’ assertions of intellectual property claims; the highly competitive nature of the markets in which we sell our products and technologies; any failure to continue developing innovative products and technologies; the lack of acceptance of any of our current or future products and technologies; obtaining regulatory approval of our current and future products and technologies; the risk that the implementation of our international realignment will not continue to produce anticipated operational and financial benefits, including a continued lower effective tax rate; the loss of our customers; the failure to retain and recruit senior management; product liability claims exposure; a failure to obtain expected returns from the amount of intangible assets we have recorded; the maintenance of our brand; the amount and type of equity awards that we may grant to employees and service providers in the future; our ongoing litigation and related matters; risks related to global economic and marketplace uncertainties related to the impact of the COVID-19 pandemic; and other factors discussed in the “Risk Factors” section of our most recent periodic reports filed with the Securities and Exchange Commission (“SEC”), including our most recent Form 10-K and Form 10-Q, all of which you may obtain for free on the SEC’s website at . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI and ORI are trademarks or registered trademarks of Masimo Corporation. MASIMO CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in millions) December 30, 2023 December 31, 2022 ASSETS Current assets Cash and cash equivalents $ 163.0 $ 202.9 Accounts receivable, net of allowance for credit losses 355.5 445.9 Inventories 545.0 501.0 Other current assets 168.4 158.8 Total current assets 1,231.9 1,308.6 Lease receivable, non-current 71.4 73.1 Deferred costs and other contract assets 57.3 41.9 Property and equipment, net 424.4 402.5 Customer relationships, net 177.7 201.6 Acquired technologies, net 129.4 160.1 Other intangible assets, net 112.8 98.9 Trademarks 232.4 262.0 Goodwill 407.7 445.4 Deferred tax assets 107.2 102.5 Other non-current assets 89.3 114.0 Total assets $ 3,041.5 $ 3,210.6 LIABILITIES AND EQUITY Current liabilities Accounts payable $ 251.5 $ 276.8 Accrued compensation 62.6 89.3 Deferred revenue and other contract-related liabilities, current 87.3 80.6 Other current liabilities 162.4 183.3 Total current liabilities 563.8 630.0 Long-term debt 871.7 941.6 Deferred tax liabilities 111.7 163.6 Other non-current liabilities 129.5 136.5 Total liabilities 1,676.7 1,871.7 Commitments and contingencies Stockholders’ equity Common stock 0.1 0.1 Treasury stock (1,169.2 ) (1,169.2 ) Additional paid-in capital 783.4 782.2 Accumulated other comprehensive (loss) income (45.3 ) 11.5 Retained earnings 1,795.8 1,714.3 Total stockholders’ equity 1,364.8 1,338.9 Total liabilities and stockholders’ equity $ 3,041.5 $ 3,210.6 MASIMO CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in millions, except per share amounts) Three Months Ended Twelve Months Ended December 30, 2023 December 31, 2022 December 30, 2023 December 31, 2022 Revenue $ 548.9 $ 617.0 $ 2,048.1 $ 2,035.8 Cost of goods sold 286.2 303.6 1,044.6 977.0 Gross profit 262.7 313.4 1,003.5 1,058.8 Operating expenses: Selling, general and administrative 159.8 185.6 664.0 657.4 Research and development 38.0 54.3 175.2 191.4 Litigation settlements 3.0 — 17.8 — Impairment charge 17.8 — 10.0 — Total operating expenses 218.6 239.9 867.0 848.8 Operating income 44.1 73.5 136.5 210.0 Non-operating loss (20.9 ) (17.6 ) (48.4 ) (16.6 ) Income before provision for income taxes 23.2 55.9 88.1 193.4 Provision for income taxes (10.8 ) 14.8 6.6 49.9 Net income $ 34.0 $ 41.1 $ 81.5 $ 143.5 Net income per share: Basic $ 0.64 $ 0.78 $ 1.54 $ 2.68 Diluted $ 0.63 $ 0.76 $ 1.51 $ 2.60 Weighted-average shares used in per share calculations: Basic 52.8 52.6 52.8 53.6 Diluted 53.7 54.1 54.1 55.2 The following table presents details of the stock-based compensation expense that is included in each functional line item in the consolidated statements of operations (in millions): Three Months Ended Twelve Months Ended December 30, 2023 December 31, 2022 December 30, 2023 December 31, 2022 Cost of goods sold $ 0.3 $ 0.2 $ 1.1 $ 1.0 Selling, general and administrative 5.6 7.8 (1.5 ) 32.9 Research and development 3.5 3.1 7.4 13.8 Total $ 9.4 $ 11.1 $ 7.0 $ 47.7 MASIMO CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited, in millions) Twelve Months Ended December 30, 2023 December 31, 2022 Cash flows from operating activities: Net income $ 81.5 $ 143.5 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 98.3 136.1 Stock-based compensation 7.0 47.7 Amortization of debt issuance costs 1.9 1.4 Loss on disposal of equipment, intangibles and other assets 0.8 0.5 Provision for credit losses 1.1 1.3 Benefit from deferred income taxes (43.9 ) (39.3 ) Impairment charge 10.0 — Changes in operating assets and liabilities: (Increase) decrease in trade accounts receivable 90.2 (138.5 ) (Increase) decrease in inventories (69.2 ) (155.9 ) (Increase) decrease in other current assets (8.6 ) (7.4 ) (Increase) decrease in lease receivable, net 1.7 (12.8 ) (Increase) decrease in deferred costs and other contract assets (14.4 ) (13.4 ) (Increase) decrease in other non-current assets 3.0 (4.9 ) Increase (decrease) in accounts payable (19.6 ) 60.5 Increase (decrease) in accrued compensation (26.8 ) (9.3 ) Increase (decrease) in deferred revenue and other contract-related liabilities 7.1 28.1 Increase (decrease) in income taxes payable (15.1 ) 3.8 Increase (decrease) in accrued liabilities (22.8 ) (16.1 ) Increase (decrease) in other non-current liabilities 11.9 4.1 Net cash provided by (used in) operating activities 94.1 29.4 Cash flows from investing activities: Purchases of property and equipment, net (44.0 ) (52.8 ) Increase in intangible assets (43.7 ) (3.5 ) Business combinations, net of cash acquired 7.5 (999.7 ) Other strategic investing activities (1.0 ) (1.7 ) Net cash (used in) provided by investing activities (81.2 ) (1,057.7 ) Cash flows from financing activities: Borrowings under revolving line of credit 189.0 1,083.9 Repayments under revolving line of credit (240.2 ) (135.4 ) Debt issuance costs — (9.3 ) Proceeds from issuance of common stock 7.0 8.1 Repurchases of common stock — (401.5 ) Payroll tax withholdings on behalf of employees for stock options (12.9 ) (25.4 ) Net cash (used in) provided by financing activities (57.1 ) 520.4 Effect of foreign currency exchange rates on cash 2.8 (30.9 ) Net increase in cash, cash equivalents and restricted cash (41.4 ) (538.8 ) Cash, cash equivalents and restricted cash at beginning of period 209.6 748.4 Cash, cash equivalents and restricted cash at end of period $ 168.2 $ 209.6