SmithKline Beecham Ltd.

Serial Entrepreneurs Dale Pfost and David Weiner Bring Broad Expertise as AxoSim Expands Its Leadership in Human Organoid Technologies Designed to Make Neurological R&D Faster, More Efficient and More SuccessfulNEW ORLEANS, Feb. 28, 2024 (GLOBE NEWSWIRE) -- AxoSim, Inc., a leader in the development and application of 3D organoid neurodiscovery platforms, today announced that current directors Dale Pfost, PhD, and David Weiner, MD, have been appointed as Co-Chairs of AxoSim’s Board of Directors. Dr. Pfost and Dr. Weiner have decades of experience in building successful biotechnology companies spanning therapeutics, diagnostics and life science tools and technologies. “Our recent acquisition of a third platform technology positions AxoSim for growth, and we are fortunate to have these two talented industry veterans assuming key leadership roles,” said Lowry Curley, PhD, co-founder and Chief Executive Officer of AxoSim. “Dale and Dave bring successful track records in building life sciences businesses, with broad and complementary skill sets. Dale’s work in life science tools and venture finance is highly relevant, as is Dave’s expertise in leading neurological drug discovery and clinical development. Both have founded new enterprises, spearheaded major financings, served as CEOs and managed M&A activities. As active participants in the New Orleans healthcare ecosystem, they know us well, and we are delighted to welcome them to the senior team.” Dr. Pfost noted, “AxoSim embodies the entrepreneur’s sweet spot--when market need, technological innovation, timing and team all align. The growing prevalence of neurological diseases places enormous burdens on patients, their families and society. Yet despite billions in investment, neurology R&D continues to disappoint. AxoSim’s transformational approach addresses a key contributor to these failures—the lack of relevant disease models—by providing functional human data from its microphysiological system (MPS) organoid technologies early in the process. AxoSim aims to become an industry leader in helping to deliver urgently needed new drugs and I welcome the opportunity to contribute to its success.” Dr. Pfost has served as CEO of six biotechnology companies, three of which became publicly traded with valuations exceeding $2 billion. Recently, he retired as CEO of Chemomab Therapeutics, after serving as CEO of Lodo Therapeutics until its acquisition. Earlier, he was founding CEO of gene-silencing innovator Acuity Pharmaceuticals, which merged to form OPKO Health. Dr. Pfost was founding CEO of Oxford GlycoSciences and genomics pioneer Orchid BioSciences, and as CEO led cancer company Receptor BioLogix to a successful acquisition. As a student he founded a company acquired by SmithKline Beckman that produced the Biomek, a leading laboratory automation system still in use today. Dr. Pfost was a General Partner at venture capital firm Advent Life Sciences and acting CEO of MicroBiome Therapeutics, which he co-founded. He earned a BS degree from the University of California, Santa Barbara, and a PhD in physics from Brown University. Dr. Pfost is the co-author of 10 scientific papers and an inventor on 10 patents. Dr. Weiner commented, “Having experienced first-hand the unmet patient need in neurology and the frustration of the many failed R&D efforts in the field, I wholeheartedly support AxoSim’s mission of harnessing advances in MPS technologies that allow researchers to obtain functional human data much earlier in the R&D process. This allows researchers to assess investigational drugs in the lab, rather than spending many years and millions of dollars to identify successes or failures in the clinic. Neurology is poised to achieve the type of progress we have recently seen in oncology, and I look forward to working with the AxoSim team to advance this important technology.” David Weiner has 30 years’ experience in the discovery and development of novel therapeutics. He is currently Chief Medical Officer of Swan Therapeutics and a co-founder of Bend Therapeutics. Previously he served in multiple leadership roles in neurology and rare disease-focused biotechnology companies, including Chief Executive Officer of Amathus Therapeutics and Chief Medical Officer at Lumos Pharma, aTyr Pharma and Proteostasis Therapeutics. Earlier in his career, Dr. Weiner held key drug development roles at EMD/Merck Serono and spent a decade in discovery research and clinical development at Acadia Pharmaceuticals. Dr. Weiner received a BA degree cum laude with highest honors from Brandeis University and an MD degree from the School of Medicine and Biomedical Sciences, SUNY Buffalo. He did a post-doctoral fellowship in neuropharmacology at the University of Vermont and was a Howard Hughes Medical Institute Research Scholar. Dr. Weiner has co-authored over 30 scientific publications and multiple patents. He serves as a director, consultant and scientific and clinical advisory board member to biotechnology companies and foundations, including the Michael J. Fox Foundation for Parkinson’s Research. AxoSim’s NerveSim®, BrainSim® and microBrain™ platforms use human induced pluripotent stem cells (iPSCs) to develop 3D biomimetic models of human brains and nerves, also known as microphysiological systems or organoids. With NerveSim®, AxoSim can study whole nerve conduction to support drug discovery efforts in chronic pain, neurotoxicity, and peripheral neuropathy, while BrainSim® includes key brain cell types for the study of myelination-related conditions such as multiple sclerosis. The recent addition of the microBrain™ technology, with its ability to chart electrical activity in the brain, supports research efforts in disorders such as epilepsy, Rett Syndrome and Parkinson’s disease. About AxoSimAxoSim empowers advancements in human neuroscience and is mission-driven to advance 3-D organoid neurodiscovery models, also known as microphysiological systems, with the potential to jumpstart the discovery and development of breakthrough therapies. It partners with biopharma companies to facilitate therapeutic innovation by empowering drug developers to obtain relevant human data early in the R&D process, reducing the time and cost of drug discovery and increasing the probabilities of success. The company’s proprietary drug discovery platforms NerveSim®, BrainSim® and microBrainTM deliver clinically relevant functional data enabling selection of better lead candidates with phenotypically accurate assays. AxoSim's platforms currently have applications in peripheral neuropathy and neuropathic pain, multiple sclerosis, seizure disorders, neurotoxicology and other diseases. For more information, visit www.axosim.com. Contacts: AxoSim Corporate AxoSim MediaGina JacksonBarbara LindheimDirector of Special ProjectsBLL Partners for AxoSimGina.jackson@axosim.comBarbara.lindheim@axosim.com954 292-6608917 355-9234 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9cc75eed-0e97-4523-8f30-60d15acbd62c

Realized Third Quarter Double-Digit Gross Profit, Operating Income and EPS Growth Year-Over-Year Delivered Third Quarter Gross Margin and Operating Margin Expansion Year-Over-Year and Sequentially Achieved Fifth Consecutive Quarter of Double-Digit Adjusted Gross Profit, Adjusted Operating Income and Adjusted EPS Growth Year-Over-Year DUBLIN, Nov. 7, 2023 /PRNewswire/ -- Third Quarter 2023 Highlights: Third quarter net sales of $1.1 billion grew 2.2% versus the prior year quarter. Organic1 net sales decreased 1.2%, including -2.8 percentage points from purposeful SKU prioritization actions to enhance margins as part of the Company's Supply Chain Reinvention Program and the HRA Pharma ("HRA") distributor transitions. Consumer Self-Care International ("CSCI") net sales increased 11.2% compared to the prior year quarter and organic net sales increased 6.2%, including -1.4 percentage points impact from the HRA distributor transition. Consumer Self-Care Americas ("CSCA") net sales decreased 2.6% compared to the prior year quarter, including -3.6 percentage points from purposeful SKU prioritization actions. Third quarter GAAP ("reported") gross margin was 36.6%, a 360 basis points improvement compared to the prior year quarter. Non-GAAP ("adjusted") gross margin was 39.5%, a 300 basis points improvement compared to the prior year quarter, and an 80 basis points improvement compared to the second quarter of 2023. Third quarter reported earnings per share ("EPS") was $0.11, compared to a loss of $(0.39) in the prior year quarter. Adjusted diluted EPS was $0.64, compared to $0.56 in the prior year quarter, an increase of 14.3%. Adjusted diluted EPS included an unfavorable impact of $0.03 from the HRA distributor transition as part of the integration plan to capture synergies. Third quarter operating cash flow was $125 million, leading to an operating cash flow conversion2 of 143%, and cash and cash equivalents on the balance sheet closed at $598 million. Company updates its fiscal 2023 organic net sales and total net sales growth outlook range to 1.0%-3.0% and 4.0%-6.0%, respectively, versus the prior year. The Company also updates its adjusted diluted EPS range outlook to $2.50-$2.60 (see Fiscal 2023 Outlook section below). Year-to-Date 2023 Highlights: Year-to-date 2023 net sales were $3.5 billion, an increase of 6.1% versus the prior year period. Organic net sales increased 2.4%, including -1.9 percentage points from purposeful SKU prioritization actions and the HRA distributor transitions. CSCI year-to-date net sales of $1.3 billion grew 12.7% versus the prior year period, with organic growth of 8.6%. CSCA year-to-date net sales of $2.2 billion grew 2.7% compared to the prior year period, while organic net sales decreased 1.0%, including -2.6 percentage points from purposeful SKU prioritization actions. Year-to-date GAAP ("reported") gross margin was 35.8%, a 330 basis points improvement compared to the prior year period. Non-GAAP ("adjusted") gross margin was 38.5%, a 300 basis points improvement compared to the prior year period. Year-to-date reported EPS was $0.17, as compared to a loss of $(0.88) in the prior year period. Year-to-date adjusted diluted EPS was $1.72, as compared to $1.32 in the prior year period, an increase of 30.3%. Adjusted diluted EPS included an unfavorable impact of $0.14 from the HRA distributor transition as part of the integration plan to capture synergies. /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, today announced financial results from continuing operations for the third quarter ended September 30, 2023. All comparisons are against the prior year fiscal third quarter, unless otherwise noted. President and CEO, Patrick Lockwood-Taylor commented, "I have immersed myself in all facets of our global business since becoming CEO four months ago and remain excited about our opportunities ahead. We have created a 'One Perrigo' blueprint that will guide us to build an operating model where our portfolio, operating systems and behaviors will be simplified, standardized and scaled. This will position us to win in self-care through the creation of a sustainable and value accretive growth engine that will drive Perrigo for the long-term." Lockwood-Taylor concluded, "The Perrigo team delivered third quarter double-digit gross profit, operating income and EPS growth year-over-year led by strong business fundamentals across the global portfolio, which more than offset continued volatility in infant formula. While we have updated our expectations for infant formula and the adverse impact from currency translation, the strength of our diversified portfolio, greater than originally anticipated margin expansion and a lower expected adjusted tax rate allows us to maintain the mid-to-lower end of our original 2023 EPS guidance range." Refer to Tables I through VIII at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company's reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows. Third Quarter Perrigo 2023 Results from Continuing Operations Reported net sales of $1.1 billion increased $24 million, or 2.2%, driven primarily by 1) +2.5 percentage points from the acquisition of the Gateway infant formula facility and the U.S. and Canadian Good Start® infant formula brand ("Gateway"), and 2) +2.1 percentage points from foreign currency translation. This growth was partially offset by a decrease in organic net sales of 1.2% including a -2.8 percentage points impact from SKU prioritization actions and the HRA distributor transitions. Organic net sales were driven primarily by strategic pricing actions of +4.7 percentage points and new products sales. This growth was more than offset by 1) -2.3 percentage points from purposeful SKU prioritization actions, 2) lower net sales in legacy U.S. Nutrition due primarily to lower manufacturing productivity stemming from the U.S. Food and Drug Administration's ("FDA") evolving industry guidelines on infant formula manufacturing, and 3) -0.5 percentage points related to HRA distributor transitions as part of the integration plan to capture synergies. Reported gross margin was 36.6%, a 360 basis points increase versus the prior year quarter. Adjusted gross margin expanded 300 basis points to 39.5% driven by strategic pricing actions, benefits from purposeful SKU prioritization actions and higher margin new products. These positive initiatives were partially offset by higher cost of goods sold inflation in CSCI and lower manufacturing productivity in U.S. Nutrition. These same factors drove gross profit growth versus the prior year quarter. Reported operating income was $62 million compared to $33 million in the prior year period. Adjusted operating income grew $17 million, or 13.0%, to $150 million driven by gross profit flow-through described above, in addition to favorable currency translation and lower distribution expenses. These benefits were partially offset by higher operating expenses, driven primarily by the addition of Gateway. Reported net income was $15 million, or $0.11 per diluted share, compared to a reported net loss of $52 million, or ($0.39) per diluted share, in the prior year. Excluding certain charges as outlined in Table I, third quarter 2023 adjusted net income was $87 million, or $0.64 per diluted share, compared to $76 million, or $0.56 per diluted share, in the prior year. Third quarter adjusted EPS included an unfavorable impact of $0.03 due to the HRA distributor transitions. Third Quarter 2023 Business Segment Results from Continuing Operations Consumer Self-Care Americas Segment CSCA reported net sales of $704 million decreased 2.6%, including +3.8 percentage points from the addition of Gateway. Organic net sales decreased 5.1% as strategic pricing actions and new product sales were more than offset by 1) -3.6 percentage points due to purposeful SKU prioritization actions to enhance margins as part of the Company's Supply Chain Reinvention Program, 2) lower net sales in legacy U.S. Nutrition due primarily to lower manufacturing productivity, and 3) lower net sales of branded OTC products. Primary category drivers are provided below. Nutrition Net sales of $131 million increased 5.1% due primarily to the Gateway acquisition. This benefit was partially offset by lower net sales in legacy infant formula due to lower manufacturing productivity stemming from the FDA's evolving industry guidelines on infant formula manufacturing and exited product lines. Upper Respiratory Net sales of $130 million decreased 1.5% due primarily to the launch and channel fill of Nasonex® in the prior year quarter and exited product lines, partially offset by higher net sales of cough cold products, led by store brand Guaifenesin-based offerings, and the new product launch of store brand Cough Relief Liquid Honey. Digestive Health Net sales of $117 million decreased 2.1% due primarily to lower net sales of store brand Proton Pump Inhibitors, partially offset by higher net sales of store brand laxatives, including Polyethylene Glycol 3350 Orange. Pain & Sleep-Aids Net sales of $94 million decreased 9.5% due primarily to purposeful SKU prioritization actions in adult analgesic offerings to focus capacity on higher margin products, partially offset by sales of new products, including store brand Dual Action Acetaminophen 250mg and Ibuprofen 125mg Tablets, and higher demand for children's analgesics products. Healthy Lifestyle Net sales of $79 million increased 7.6% due primarily to higher volumes and market share gains in smoking cessation products. Oral Care Net sales of $77 million decreased 8.5% due primarily to purposeful SKU prioritization actions and timing of promotions compared to the prior year quarter, partially offset by higher net sales of store brand teeth whitening products and power toothbrush handles. Skin Care Net sales of $48 million decreased 2.7% due primarily to exited product lines, partially offset by strong performance of Mederma®. Women's Health Net sales of $10 million decreased 17.7% due primarily to purposeful SKU prioritization actions in feminine hygiene. Vitamins, Minerals, and Supplements ("VMS") and Other Net sales of $18 million decreased 24.4% due primarily to purposeful SKU prioritization actions. Reported gross margin was 31.8%, a 550 basis points increase versus the prior year quarter. Adjusted gross margin expanded 430 basis points to 32.5% driven by 1) strategic pricing actions, 2) productivity savings in U.S. OTC and U.S. Oral Care, 3) benefits from SKU prioritization actions and exited product lines, and 4) the addition of the higher margin Gateway acquisition. These benefits were partially offset by lower manufacturing productivity in U.S. Nutrition. Reported operating income was $91 million compared to $75 million in the prior year quarter. Adjusted operating income increased $4 million, or 3.5%, to $108 million driven by gross profit flow-through resulting from strategic pricing actions, productivity savings in U.S. OTC and U.S. Oral Care, and the addition of Gateway. These benefits were partially offset by higher operating expenses, driven primarily by the addition of operating expenses related to Gateway, lower manufacturing productivity in U.S. Nutrition and Opill® pre-launch investments. Consumer Self-Care International Segment CSCI reported net sales increased 11.2% and constant currency net sales increased 5.2%. Reported net sales growth included a favorable impact of +6.0 percentage points related to foreign currency translation and an unfavorable impact of -1.4 percentage points related to HRA distributor transitions. Organic net sales increased 6.2% driven by strategic pricing actions and new products. Primary category drivers are provided below. Skin Care Net sales of $87 million increased 6.9%, or an increase of 4.4% excluding the impact of currency, driven primarily by the Sebamed and ACO brands, partially offset by lower net sales in wound care products. Upper Respiratory Net sales of $78 million increased 13.0%, or 5.1% excluding the impact of currency, due primarily to higher demand for cough cold products, including Coldrex and Bronchostop. Net sales of U.K. store brand cough cold products were also higher compared to the prior year period. Pain & Sleep-Aids Net sales of $61 million increased 32.5%, or an increase of 23.0% excluding the impact of currency, due primarily to quarterly phasing of Solpadeine, higher net sales in store brands and increased demand for Nytol. Healthy Lifestyle Net sales of $52 million increased 10.1%, or 4.4% excluding the impact of currency, due primarily to higher net sales of anti-parasite offerings that continue to outpace strong category growth and higher demand for smoking cessation products. This growth was partially offset by lower category consumption in weight loss, impacting XLS Medical. VMS Net sales of $46 million decreased 0.6%, or 7.5% excluding the impact of currency, due primarily to lower category consumption, impacting sales of Davitamon and Abtei. Women's Health Net sales of $29 million decreased 0.7%, or 7.0% excluding the impact of currency, due primarily to lower net sales in contraceptive products, which were primarily impacted by distributor transitions. Oral Care Net sales of $25 million increased 14.3%, or 6.5% excluding the impact of currency, due primarily to higher net sales of power toothbrush handles, Plackers® and improved service levels compared to the prior year. Digestive Health and Other Net sales of $43 million increased 14.6%, or 10.8% excluding the impact of currency, due primarily to higher net sales of store brand digestive health products and distribution brands. Reported gross margin was 44.5%, a decrease of 120 basis points compared to the prior year quarter. Adjusted gross margin decreased 120 basis points to 51.2% as strategic pricing actions and higher margin new products were more than offset by less favorable product mix and higher cost of goods sold inflation. Reported operating income was $14 million for the quarter compared to $1 million in the prior year. Adjusted operating income increased $18 million, or 28.2%, to $80 million due primarily to the same factors as the adjusted gross margin, in addition to favorable currency translation and lower advertising and promotion investments. These benefits were partially offset by higher administrative expenses. Fiscal 2023 Outlook The Company's fiscal year 2023 updated outlook is provided below: Reported net sales growth of 4.0% to 6.0% compared to the prior year, versus the previous range of 7.0% to 11.0%, Organic net sales growth of 1.0% to 3.0% compared to the prior year, versus the previous range of 3.0% to 6.0%, Interest expense of approximately $180 million, Full year adjusted tax rate of approximately ~14.0%, versus the previous expectation of ~17.0%, Adjusted diluted EPS range of between $2.50 to $2.60 versus the previous range of $2.50 to $2.70, and Operating cash flow conversion (operating cash flow as a percentage of adjusted net income) of approximately 100%. About Perrigo Perrigo Company plc (NYSE: PRGO) is a leading provider of Consumer Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at . Webcast and Conference Call Information The earnings conference call will be available live on Tuesday, November 7, 2023 at 8:30 A.M. (EST) via webcast to interested parties in the investor relations section of the Perrigo website at or by phone at 888-317-6003, International 412-317-6061, and reference ID # 0043209. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EST) Tuesday, November 7, until midnight Tuesday, November 14, 2023. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 7630596. Forward-Looking Statements Certain statements in this press release are "forward-looking statements." These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "forecast," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control, including: supply chain impacts on the Company's business, including those caused or exacerbated by armed conflict, trade and other economic sanctions and/or disease; general economic, credit, and market conditions; the impact of the war in Ukraine and any escalation thereof, including the effects of economic and political sanctions imposed by the United States, United Kingdom, European Union, and other countries related thereto; the outbreak or escalation of conflict in other regions where we do business; future impairment charges, if we determine that the carrying amount of specific assets may not be recoverable from the expected future cash flows of such assets; customer acceptance of new products; competition from other industry participants, some of whom have greater marketing resources or larger market shares in certain product categories than the Company does; pricing pressures from customers and consumers; resolution of uncertain tax positions and any litigation relating thereto, ongoing or future government investigations and regulatory initiatives; uncertainty regarding the Company's ability to obtain and maintain its regulatory approvals; potential costs and reputational impact of product recalls or sales halts; potential adverse changes to U.S. and foreign tax, healthcare and other government policy; the effect of the coronavirus (COVID-19) pandemic and its variants; the timing, amount and cost of any share repurchases (or the absence thereof); fluctuations in currency exchange rates and interest rates; the Company's ability to achieve the benefits expected from the sale of its Rx business and the risk that potential costs or liabilities incurred or retained in connection with that transaction may exceed the Company's estimates or adversely affect the Company's business or operations; the Company's ability to achieve the benefits expected from the acquisitions of Héra SAS ("HRA Pharma") and Nestlé's Gateway infant formula plant along with the U.S. and Canadian rights to the GoodStart® infant formula brand and other related formula brands ("Gateway") and/or the risks that the Company's synergy estimates are inaccurate or that the Company faces higher than anticipated integration or other costs in connection with the acquisitions; risks associated with the integration of HRA Pharma and Gateway, including the risk that growth rates are adversely affected by any delay in the integration of sales and distribution networks; the consummation and success of other announced and unannounced acquisitions or dispositions, and the Company's ability to realize the desired benefits thereof; and the Company's ability to execute and achieve the desired benefits of announced cost-reduction efforts and other strategic initiatives and investments, including the Company's ability to achieve the expected benefits from its Supply Chain Reinvention Program. Adverse results with respect to pending litigation could have a material adverse impact on the Company's operating results, cash flows and liquidity, and could ultimately require the use of corporate assets to pay damages, reducing assets that would otherwise be available for other corporate purposes. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2022, as well as the Company's subsequent filings with the United States Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Non-GAAP Measures This press release contains certain non-GAAP measures. A "non-GAAP financial measure" is defined as a numerical measure of a company's financial performance that excludes or includes amounts different from the most directly comparable measure calculated and presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP) in the statements of operations, balance sheets or statements of cash flows of the Company. Pursuant to the requirements of the U.S. Securities and Exchange Commission, the Company has provided reconciliations to the most directly comparable U.S. GAAP measures for the following non-GAAP financial measures referred to in this press release: net sales growth on an organic basis, which excludes acquisitions, divested businesses, and the impact of currency, adjusted gross profit, adjusted net income, adjusted operating income, adjusted diluted earnings per share, constant currency net sales growth, adjusted operating income and adjusted diluted earnings per share, adjusted gross margin, and adjusted operating margin. These non-GAAP financial measures should be considered as supplements to the GAAP reported measures, should not be considered replacements for, or superior to the GAAP measures and may not be comparable to similarly named measures used by other companies. The Company presents these non-GAAP financial measures in order to provide transparency to our investors because they are measures that management uses to assess both management performance and the financial performance of our operations and to allocate resources. In addition, management believes that these measures may assist investors with understanding and evaluating our initiatives to drive improved financial performance and enables investors to supplementally compare our operating performance with the operating performance of our competitors including with those of our competitors having different capital structures. While we have excluded certain of these items from historical non-GAAP financial measures, there is no guarantee that the items excluded from non-GAAP financial measures will not continue into future periods. For instance, we expect to continue to experience charges for facility exit and impairment charges and inventory write-downs related to store closures as the Company continues to complete a multi-year strategic initiative designed to improve overall performance. We also expect to continue to experience and report restructuring-related charges associated with continued execution of our strategic initiatives. The Company provides non-GAAP financial measures as additional information that it believes is useful to investors and analysts in evaluating the performance of the Company's ongoing operating trends, facilitating comparability between periods and, where applicable, with companies in similar industries and assessing the Company's prospects for future performance. These non-GAAP financial measures exclude items, such as impairment charges, restructuring charges, and acquisition and integration-related charges, that by their nature affect comparability of operational performance or that we believe obscure underlying business operational trends. The intangible asset amortization excluded from these non-GAAP financial measure represents the entire amount recorded within the Company's GAAP financial statements and is excluded because the amortization, unlike the related revenue, is not affected by operations of any particular period unless an intangible asset becomes impaired or the estimated useful life of an intangible asset is revised. The revenue generated by the associated intangible assets has not been excluded from the related non-GAAP financial measure. The non-GAAP measures the Company provides are consistent with how management analyzes and assesses the operating performance of the Company, and disclosing them provides investor insight into management's view of the business. Management uses these adjusted financial measures for planning and forecasting in future periods, and evaluating segment and overall operating performance. In addition, management uses certain of the profit measures as factors in determining compensation. Non-GAAP measures related to profit measurements, which include adjusted gross profit, adjusted net income, adjusted diluted EPS, constant currency adjusted diluted EPS, constant currency adjusted operating income, adjusted gross margin and adjusted operating margin are useful to investors as they provide them with supplemental information to enhance their understanding of the Company's underlying business performance and trends, and enhance the ability of investors and analysts to compare the Company's period-to-period financial results. Management believes that adjusted gross margin and adjusted operating margin are useful to investors, in addition to the reasons discussed above, by allowing them to more easily compare and analyze trends in the Company's peer business group and assisting them in comparing the Company's overall performance to that of its competitors. The Company also discloses net sales growth excluding the impact of currency on an organic basis. The Company believes these supplemental financial measures provide investors with consistency in financial reporting, enabling meaningful comparisons of past and present underlying operating results, and also facilitate analysis of the Company's operating performance and acquisition and divestiture trends. A copy of this press release, including the reconciliations, is available on the Company's website at . SOURCE Perrigo Company plc

Achieved Year-Over-Year and Sequential Gross and Operating Margin Expansion Delivered Strong Operating Income and EPS Growth Reaffirming 2023 Outlook DUBLIN, Aug. 8, 2023 /PRNewswire/ -- Second Quarter 2023 Highlights: Second quarter net sales of $1.2 billion grew 6.4%, or 6.6% on a constant currency1 basis, versus the prior year quarter. Organic2 net sales grew 0.8%, including -2.7 percentage points from purposeful SKU prioritization actions to enhance margins as part of the Company's Supply Chain Reinvention Program. Consumer Self-Care Americas ("CSCA") net sales grew 3.1%, including -4.1 percentage points from purposeful SKU prioritization actions. Consumer Self-Care International ("CSCI") net sales grew 12.4% compared to the prior year quarter, while organic net sales increased 7.1%. Second quarter GAAP ("reported") gross margin was 35.9%, a 270 basis points improvement compared to the prior year quarter. Non-GAAP ("adjusted") gross margin was 38.7%, a 220 basis points improvement compared to the prior year quarter, and a 120 basis points improvement sequentially compared to the first quarter of 2023. Second quarter reported earnings per share ("EPS") was $0.06, compared to a loss of $(0.48) in the prior year quarter. Adjusted diluted EPS was $0.63, compared to $0.43 in the prior year quarter, an increase of 46.5%. Adjusted EPS included a favorable discrete tax benefit of $0.08 from the resolution of various tax matters related to prior years and an unfavorable impact of $0.05 due to HRA Pharma ("HRA") distributor transition sales returns as part of the integration plan to capture synergies. Second quarter operating cash flow was $53 million, leading to cash and cash equivalents on the balance sheet of $555 million as of second quarter end. Perrigo reaffirms its fiscal 2023 organic net sales and total net sales growth outlook range of 3.0%-6.0% and 7.0%-11.0%, respectively, versus the prior year, and adjusted diluted EPS range outlook of $2.50-$2.70. On June 30, 2023, Patrick Lockwood-Taylor began his tenure as Perrigo President, CEO and member of the Board of Directors. On July 13, 2023, Perrigo announced that the U.S. Food and Drug Administration ("FDA") approved Opill®, the first ever daily birth control pill available over-the-counter ("OTC") for all ages, in the United States. First Half 2023 Highlights: Net sales for the first half of 2023 were $2.4 billion, an increase of 8.1%, or 9.7% on a constant currency basis, versus the prior year period. Organic net sales increased 3.5%, including -1.4 percentage points from purposeful SKU prioritization actions. CSCA first half net sales of $1.5 billion grew 5.3% compared to the prior year period, with organic growth of 0.6%, including -2.0 percentage points from purposeful SKU prioritization actions. CSCI first half net sales of $860 million grew 13.5%, or 18.0% on a constant currency basis, versus the prior year period, with organic growth of 9.0%. Reported EPS for the first half of 2023 was $0.06, as compared to a loss of $(0.49) in the prior year period. Adjusted diluted EPS for the first half of 2023 was $1.08, as compared to $0.76 in the prior year period, an increase of 42.1%. Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, today announced financial results from continuing operations for the second quarter ended July 1, 2023. All comparisons are against the prior year fiscal second quarter, unless otherwise noted. President and CEO, Patrick Lockwood-Taylor commented, "Perrigo is well positioned in the consumer self-care industry with tremendous manufacturing scale in the U.S. and strong customer relationships across the U.S. and Europe. The Company has an expansive product portfolio, with many opportunities to differentiate against competition and win with consumers. After nearly 40 days as CEO, I remain extremely excited about the long-term potential for our business. There has been a lot of work accomplished over the past five years to position Perrigo for success, but there is still a lot of work to be done to build out our framework for sustainable growth and consistently win with consumers and customers." Lockwood-Taylor continued, "Our second quarter earnings results reflect the dedication and hard work of the entire Perrigo team, who also continued to make meaningful progress against key operational initiatives, including our Supply Chain Reinvention Program, and integrating and synergizing both the HRA and infant formula acquisitions." "Our second quarter performance underscores the strength in our global self-care categories as we delivered solid financial results," commented Eduardo Bezerra, Executive Vice President and CFO. "Importantly, margins expanded compared to the prior year and sequentially, and both adjusted operating income growth and cash on the balance sheet were strong. As global consumer consumption is normalizing and despite adding pre-launch investments for Opill® into our plans for the second half of 2023, we are reaffirming our 2023 adjusted EPS outlook range." Refer to Tables I through VI at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company's reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows. Second Quarter Perrigo 2023 Results from Continuing Operations Reported net sales of $1.2 billion increased $71 million, or 6.4%, and constant currency net sales increased 6.6%. Reported net sales growth was driven by 1) +4.0 percentage points from the acquisition of the Gateway infant formula facility and U.S. & Canadian Good Start® infant formula brand ("Gateway"), 2) +2.3 percentage points of growth from the acquisition of HRA, including an unfavorable impact of -0.9 percentage points related to distributor transition sales returns as part of the integration plan to capture synergies, and 3) -0.2 percentage points from foreign currency translation. Organic net sales growth of 0.8% was driven primarily by 1) +4.8 percentage points from strategic pricing actions, and 2) new products sales and growth in e-commerce. This growth was partially offset by 1) -2.7 percentage points from purposeful SKU prioritization actions to enhance margins as part of the Company's Supply Chain Reinvention Program, and 2) -1.1 percentage points from a weaker allergy season in the U.S. compared to the prior year. Reported gross margin was 35.9%, a 270 basis point increase versus the prior year quarter. Adjusted gross margin expanded 220 basis points to 38.7% driven by higher margin acquisitions, strategic pricing actions and benefits from the purposeful SKU prioritization actions noted above. These positive factors were partially offset by the impacts from inflation and lower manufacturing productivity in the U.S. Nutrition business stemming from the FDA's evolving regulations on infant formula manufacturing. Reported operating income was $57 million compared to a loss of $7 million in the prior year period. Adjusted operating income grew $21 million, or 17.9%, to $137 million driven by higher gross profit flow-through from acquisitions and strategic pricing actions. These increases were partially offset by 1) higher operating expenses, driven primarily by the addition of HRA and Gateway, 2) the unfavorable impact from inflation, 3) lower manufacturing productivity in the U.S. Nutrition business, and 4) $9 million from the HRA distributor transition sales returns. Reported net income was $9 million, or $0.06 per diluted share, compared to a reported net loss of $65 million, or ($0.48) per diluted share, in the prior year. Excluding certain charges as outlined in Table I, second quarter 2023 adjusted net income was $87 million, or $0.63 per diluted share, compared to $59 million, or $0.43 per diluted share, in the prior year. Second quarter adjusted EPS included a discrete tax benefit of $0.08 from the resolution of various tax matters related to prior years and an unfavorable impact of $0.05 due to the HRA distributor transition sales returns. Second Quarter 2023 Business Segment Results from Continuing Operations Consumer Self-Care Americas Segment CSCA reported net sales increased 3.1% to $751 million. Reported net sales growth was driven by +6.2 percentage points from the addition of Gateway. Organic net sales decreased 2.7% as strategic pricing actions and new product sales were more than offset by 1) -4.1 percentage points due to purposeful SKU prioritization actions to enhance margins as part of the Company's Supply Chain Reinvention Program, 2) a weaker allergy season compared to the prior year adversely impacting net sales by -1.8 percentage points, and 3) lower sales volumes in contract manufacturing. Primary category drivers are provided below. Nutrition Net sales of $165 million increased 31.7% due primarily to the Gateway acquisition and growth in legacy infant formula products. This growth was partially offset by lower net sales in store brand oral electrolytes and the discontinuation of nutritional drinks. Upper Respiratory Net sales of $138 million decreased 5.6% due primarily to lower net sales of allergy products driven by a weaker allergy season compared to the prior year. This headwind was partially offset by higher net sales of cough cold products, including store brand Cough DM and Guaifenesin-based offerings. Digestive Health Net sales of $127 million increased 1.3% due primarily to higher net sales of store brand Omeprazole and new products, including Polyethylene Glycol 3350 Orange, which were partially offset by lower net sales from contract manufacturing. Pain & Sleep-Aids Net sales of $97 million decreased 5.1% due primarily to purposeful SKU prioritization in adult analgesic offerings to focus capacity on higher margin products, partially offset by higher demand for children's analgesics products. Oral Care Net sales of $77 million increased 0.4% due primarily to higher net sales of Plackers® and store brand teeth whitening products, which were mostly offset by lower sales of manual toothbrushes, including branded Firefly® and REACH®, and store brand offerings. Healthy Lifestyle Net sales of $67 million were flat due primarily to increased consumer demand for store brand smoking cessation products being offset by lost distribution at a specific customer. Skin Care Net sales of $51 million increased 4.5% due primarily to the addition of HRA brands, including Mederma® and Compeed®. Women's Health Net sales of $13 million increased 4.2% due primarily to the addition of HRA brands, including ella®. Vitamins, Minerals, and Supplements ("VMS") and Other Net sales of $17 million decreased 32.7% due primarily to purposeful SKU prioritization actions. Reported gross margin was 29.9%, a 350 basis points increase versus the prior year quarter. Adjusted gross margin expanded 260 basis points versus the prior year quarter to 30.5% as strategic pricing actions, higher margin acquisitions and benefits from SKU prioritization actions more than offset lower manufacturing productivity in the U.S. Nutrition business and an unfavorable impact from inflation. Reported operating income was $98 million compared to $86 million in the prior year quarter. Adjusted operating income increased $9 million, or 9.0%, to $114 million as gross profit flow-through and lower distribution costs were partially offset by higher operating expenses, driven primarily by the addition of Gateway. Consumer Self-Care International Segment CSCI reported net sales increased 12.4% and constant currency net sales increased 12.8%. Reported net sales growth benefited from +5.7 percentage points from the acquisition of HRA, including an unfavorable impact of -2.7 percentage points related to distributor transition sales returns, and -0.4 percentage points related to foreign currency translation. Organic net sales increased 7.1% driven by strategic pricing actions and favorable volume/mix, including benefits from new products. Primary category drivers are provided below. Skin Care Net sales of $123 million increased 20.0%, or an increase of 23.3% excluding the impact of currency, driven primarily by the brands Sebamed and Biodermal, and the addition of HRA brands, including Compeed®. Upper Respiratory Net sales of $65 million increased 10.4%, or 9.4% excluding the impact of currency, due primarily to higher demand for cough cold products, including Bronchostop and Coldrex. Net sales of the U.K. allergy brand Beconase were also higher compared to the prior year period. Healthy Lifestyle Net sales of $61 million increased 2.5%, or 1.9% excluding the impact of currency, due primarily to higher net sales of anti-parasite offerings that continue to outpace strong category growth. This growth was partially offset by lower category consumption in weight loss, impacting XLS Medical. Pain & Sleep-Aids Net sales of $53 million increased 7.5%, or an increase of 6.9% excluding the impact of currency, due primarily to higher demand for Solpadeine and Nytol. VMS Net sales of $42 million decreased 1.9%, or 3.5% excluding the impact of currency, due primarily to lower category consumption, impacting sales of Davitamon and Abtei. Women's Health Net sales of $32 million increased 36.9%, or 35.2% excluding the impact of currency, due primarily to the addition of HRA brands, including ellaOne® and NorLevo®. Oral Care Net sales of $22 million increased 4.9%, or 4.4% excluding the impact of currency, due primarily to higher category consumption, improved product mix and new products. Digestive Health and Other Net sales of $46 million increased 21.3%, or 23.2% excluding the impact of currency, due primarily to the addition of the HRA Rare Diseases portfolio in the Other category. Reported gross margin was 46.0%, an increase of 30 basis points compared to the prior year quarter. Adjusted gross margin expanded 30 basis points versus the prior year quarter to 52.6% due primarily to strategic pricing actions, the higher margin HRA acquisition and favorable volume/mix. These drivers were partially offset by cost of goods sold inflation . Reported operating income was $9 million for the quarter compared to $2 million in the prior year. Adjusted operating income increased $16 million, or 29.7%, to $70 million due primarily to strategic pricing actions, the addition of HRA and favorable volume/mix. This growth was partially offset by cost of goods sold inflation and increased operating expenses, primarily driven by the inclusion of HRA. Fiscal 2023 Outlook The Company's fiscal year 2023 outlook is provided below: Reported net sales growth of 7.0% to 11.0% compared to the prior year, Organic net sales growth of 3.0% to 6.0% compared to the prior year, Interest expense of approximately $180 million, Adjusted tax rate for the second half of 2023 is expected to be approximately 19.5%, leading to a full year adjusted tax rate for 2023 of 17.0%, which includes the second quarter adjusted EPS discrete tax benefit of $0.08, Adjusted diluted EPS range of between $2.50 to $2.70, including pre-launch investments for Opill® following FDA approval, and Operating cash flow conversion (operating cash flow as a percentage of adjusted net income) of approximately 100%. About Perrigo Perrigo Company plc (NYSE: PRGO) is a leading provider of Consumer Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at . Webcast and Conference Call Information The earnings conference call will be available live on Tuesday August 8, 2023 at 8:30 A.M. (EST) via webcast to interested parties in the investor relations section of the Perrigo website at or by phone at 888-317-6003, International 412-317-6061, and reference ID # 6916237. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EST) Tuesday, August 8, until midnight Tuesday, August 15, 2023. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 4782572. Forward-Looking Statements Certain statements in this press release are "forward-looking statements." These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "forecast," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control, including: supply chain impacts on the Company's business, including those caused or exacerbated by armed conflict, trade and other economic sanctions and/or disease; general economic, credit, and market conditions; the impact of the war in Ukraine and any escalation thereof, including the effects of economic and political sanctions imposed by the United States, United Kingdom, European Union, and other countries related thereto; the outbreak or escalation of conflict in other regions where we do business; future impairment charges, if we determine that the carrying amount of specific assets may not be recoverable from the expected future cash flows of such assets; customer acceptance of new products; competition from other industry participants, some of whom have greater marketing resources or larger market shares in certain product categories than the Company does; pricing pressures from customers and consumers; resolution of uncertain tax positions and any litigation relating thereto, ongoing or future government investigations and regulatory initiatives; uncertainty regarding the Company's ability to obtain and maintain its regulatory approvals; potential costs and reputational impact of product recalls or sales halts; potential adverse changes to U.S. and foreign tax, healthcare and other government policy; the effect of the coronavirus (COVID-19) pandemic and its variants; the timing, amount and cost of any share repurchases (or the absence thereof); fluctuations in currency exchange rates and interest rates; the Company's ability to achieve the benefits expected from the sale of its Rx business and the risk that potential costs or liabilities incurred or retained in connection with that transaction may exceed the Company's estimates or adversely affect the Company's business or operations; the Company's ability to achieve the benefits expected from the acquisitions of Héra SAS ("HRA Pharma") and Nestlé's Gateway infant formula plant along with the U.S. and Canadian rights to the GoodStart® infant formula brand and other related formula brands ("Gateway") and/or the risks that the Company's synergy estimates are inaccurate or that the Company faces higher than anticipated integration or other costs in connection with the acquisitions; risks associated with the integration of HRA Pharma and Gateway, including the risk that growth rates are adversely affected by any delay in the integration of sales and distribution networks; the consummation and success of other announced and unannounced acquisitions or dispositions, and the Company's ability to realize the desired benefits thereof; and the Company's ability to execute and achieve the desired benefits of announced cost-reduction efforts and other strategic initiatives and investments, including the Company's ability to achieve the expected benefits from its Supply Chain Reinvention Program. Adverse results with respect to pending litigation could have a material adverse impact on the Company's operating results, cash flows and liquidity, and could ultimately require the use of corporate assets to pay damages, reducing assets that would otherwise be available for other corporate purposes. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2022, as well as the Company's subsequent filings with the United States Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Non-GAAP Measures This press release contains certain non-GAAP measures. A "non-GAAP financial measure" is defined as a numerical measure of a company's financial performance that excludes or includes amounts different from the most directly comparable measure calculated and presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP) in the statements of operations, balance sheets or statements of cash flows of the Company. Pursuant to the requirements of the U.S. Securities and Exchange Commission, the Company has provided reconciliations to the most directly comparable U.S. GAAP measures for the following non-GAAP financial measures referred to in this press release: net sales growth on an organic basis, which excludes acquisitions, divested businesses, and the impact of currency, adjusted gross profit, adjusted net income, adjusted operating income, adjusted diluted earnings per share, constant currency net sales growth, adjusted operating income and adjusted diluted earnings per share, adjusted gross margin, and adjusted operating margin. These non-GAAP financial measures should be considered as supplements to the GAAP reported measures, should not be considered replacements for, or superior to the GAAP measures and may not be comparable to similarly named measures used by other companies. The Company provides non-GAAP financial measures as additional information that it believes is useful to investors and analysts in evaluating the performance of the Company's ongoing operating trends, facilitating comparability between periods and, where applicable, with companies in similar industries and assessing the Company's prospects for future performance. These non-GAAP financial measures exclude items, such as impairment charges, restructuring charges, and acquisition and integration-related charges, that by their nature affect comparability of operational performance or that we believe obscure underlying business operational trends. The intangible asset amortization excluded from these non-GAAP financial measure represents the entire amount recorded within the Company's GAAP financial statements and is excluded because the amortization, unlike the related revenue, is not affected by operations of any particular period unless an intangible asset becomes impaired or the estimated useful life of an intangible asset is revised. The revenue generated by the associated intangible assets has not been excluded from the related non-GAAP financial measure. The non-GAAP measures the Company provides are consistent with how management analyzes and assesses the operating performance of the Company, and disclosing them provides investor insight into management's view of the business. Management uses these adjusted financial measures for planning and forecasting in future periods, and evaluating segment and overall operating performance. In addition, management uses certain of the profit measures as factors in determining compensation. Non-GAAP measures related to profit measurements, which include adjusted gross profit, adjusted net income, adjusted diluted EPS, constant currency adjusted diluted EPS, constant currency adjusted operating income, adjusted gross margin and adjusted operating margin are useful to investors as they provide them with supplemental information to enhance their understanding of the Company's underlying business performance and trends, and enhance the ability of investors and analysts to compare the Company's period-to-period financial results. Management believes that adjusted gross margin and adjusted operating margin are useful to investors, in addition to the reasons discussed above, by allowing them to more easily compare and analyze trends in the Company's peer business group and assisting them in comparing the Company's overall performance to that of its competitors. The Company also discloses net sales growth excluding the impact of currency on an organic basis. The Company believes these supplemental financial measures provide investors with consistency in financial reporting, enabling meaningful comparisons of past and present underlying operating results, and also facilitate analysis of the Company's operating performance and acquisition and divestiture trends. A copy of this press release, including the reconciliations, is available on the Company's website at . Sequential Comparison SOURCE Perrigo Company plc