Piedmont Lithium Executive Leadership to Share Company Developments at June Industry Conferences

Piedmont Lithium Executive Leadership to Share Company Developments at June Industry Conferences

BELMONT, N.C.–(BUSINESS WIRE)–Piedmont Lithium Inc. (“Piedmont” or “Company”) (Nasdaq:PLL; ASX:PLL), a developer of lithium resources critical to the U.S. electric vehicle supply chain, today announced executive participation in the following industry conferences in June:

  • KeyBanc 2023 Industrials & Basic Materials Conference – Boston, MA, June 1
  • TD Cowen Sustainability Week – virtual, June 6
  • Clarksons Battery Value Chain Conference – virtual, June 6
  • Benchmark Battery Gigafactories USA – Washington, D.C., June 8-9
  • Bank of America Virtual Lithium Day – virtual, June 13
  • Evercore ISI Global Clean Energy & Transition Technologies Summit – New York, NY, June 15-16
  • Fastmarkets Lithium Supply and Battery Raw Materials Americas – Las Vegas, NV, June 20-22
  • J.P. Morgan Energy, Power & Renewables Conference – New York, NY, June 21-22
  • TD Cowen NDR Europe – London, Paris, Switzerland, June 27-29
  • Canaccord Toronto Lithium Day – Toronto, Canada, June 27

“We are advancing across our global portfolio of projects to supply critical lithium resources to the U.S. battery and manufacturing supply chains, and we are looking forward to sharing our progress with the industry and investors this month,” said Piedmont Chief Executive Officer Keith Phillips. “First commercial shipments and revenue generation from North American Lithium are nearing, as is a DFS for the Ewoyaa Lithium Project. Meanwhile, permitting is progressing at both Tennessee Lithium and Carolina Lithium.”

Piedmont’s global portfolio of projects includes the following targets, subject to permitting, approvals, and financing:

  • Quebec: first commercial shipment of spodumene concentrate from Sayona Quebec’s North American Lithium – Q3 2023
  • Ghana: spodumene concentrate production at Atlantic Lithium’s Ewoyaa Lithium Project – 2025
  • Tennessee Lithium: lithium hydroxide production from spodumene concentrate sourced from our international investments – 2026
  • Carolina Lithium: integrated spodumene concentrate and lithium hydroxide production – 2027

About Piedmont Lithium

Piedmont Lithium (Nasdaq:PLL; ASX:PLL) is developing a world-class, multi-asset, integrated lithium business focused on enabling the transition to a net zero world and the creation of a clean energy economy in North America. Our goal is to become one of the largest lithium hydroxide producers in North America by processing spodumene concentrate produced from assets where we hold an economic interest. Our projects include our Carolina Lithium and Tennessee Lithium projects in the United States and partnerships in Quebec with Sayona Mining (ASX:SYA) and in Ghana with Atlantic Lithium (AIM:ALL; ASX:A11). These geographically diversified operations will enable us to play a pivotal role in supporting America’s move toward energy independence and the electrification of transportation and energy storage. For more information, follow us on Twitter @PiedmontLithium and visit www.piedmontlithium.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of or as described in securities legislation in the United States and Australia, including statements regarding exploration, development, and construction activities of Sayona Mining, Atlantic Lithium and Piedmont; current plans for Piedmont’s mineral and chemical processing projects; strategy; and strategy. Such forward-looking statements involve substantial and known and unknown risks, uncertainties, and other risk factors, many of which are beyond our control, and which may cause actual timing of events, results, performance or achievements and other factors to be materially different from the future timing of events, results, performance, or achievements expressed or implied by the forward-looking statements. Such risk factors include, among others: (i) that Piedmont, Sayona Mining, or Atlantic Lithium will be unable to commercially extract mineral deposits, (ii) that Piedmont’s, Sayona Mining’s or Atlantic Lithium’s properties may not contain expected reserves, (iii) risks and hazards inherent in the mining business (including risks inherent in exploring, developing, constructing and operating mining projects, environmental hazards, industrial accidents, weather or geologically related conditions), (iv) uncertainty about Piedmont’s ability to obtain required capital to execute its business plan, (v) Piedmont’s ability to hire and retain required personnel, (vi) changes in the market prices of lithium and lithium products, (vii) changes in technology or the development of substitute products, (viii) the uncertainties inherent in exploratory, developmental and production activities, including risks relating to permitting, zoning and regulatory delays related to our projects as well as the projects of our partners in Quebec and Ghana, (ix) uncertainties inherent in the estimation of lithium resources, (x) risks related to competition, (xi) risks related to the information, data and projections related to Sayona Mining or Atlantic Lithium, (xii) occurrences and outcomes of claims, litigation and regulatory actions, investigations and proceedings, (xiii) risks regarding our ability to achieve profitability, enter into and deliver product under supply agreements on favorable terms, our ability to obtain sufficient financing to develop and construct our projects, our ability to comply with governmental regulations and our ability to obtain necessary permits, and (xiv) other uncertainties and risk factors set out in filings made from time to time with the U.S. Securities and Exchange Commission (“SEC”) and the Australian Securities Exchange, including Piedmont’s most recent filings with the SEC. The forward-looking statements, projections and estimates are given only as of the date of this press release and actual events, results, performance, and achievements could vary significantly from the forward-looking statements, projections and estimates presented in this press release. Readers are cautioned not to put undue reliance on forward-looking statements. Piedmont disclaims any intent or obligation to update publicly such forward-looking statements, projections, and estimates, whether as a result of new information, future events or otherwise. Additionally, Piedmont, except as required by applicable law, undertakes no obligation to comment on analyses, expectations or statements made by third parties in respect of Piedmont, its financial or operating results or its securities.

For further information:

Erin Sanders

SVP, Corporate Communications &

Investor Relations

T: +1 704 575 2549

E: [email protected]

Christian Healy/Jeff Siegel

Media Inquiries

E: [email protected]

E: [email protected]

KEYWORDS: North Carolina Ireland Australia/Oceania United States United Kingdom North America Australia Europe

INDUSTRY KEYWORDS: Automotive Technology Chemicals/Plastics Sustainability Manufacturing General Automotive Environment Public Relations/Investor Relations Other Energy Other Transport Batteries Communications Green Technology Alternative Energy Energy Transport Other Natural Resources Mining/Minerals EV/Electric Vehicles Natural Resources

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The Buckle, Inc. Reports May 2023 Net Sales

The Buckle, Inc. Reports May 2023 Net Sales

KEARNEY, Neb.–(BUSINESS WIRE)–
The Buckle, Inc. (NYSE: BKE) announced today that comparable store net sales, for stores open at least one year, for the 4-week period ended May 27, 2023 decreased 6.4 percent from comparable store net sales for the 4-week period ended May 28, 2022. Net sales for the 4-week fiscal month ended May 27, 2023 decreased 5.3 percent to $89.3 million from net sales of $94.3 million for the prior year 4-week fiscal month ended May 28, 2022.

Comparable store net sales year-to-date for the 17-week period ended May 27, 2023 decreased 8.6 percent from comparable store net sales for the 17-week period ended May 28, 2022. Net sales for the 17-week fiscal period ended May 27, 2023 decreased 7.7 percent to $372.1 million compared to net sales of $403.4 million for the prior year 17-week fiscal period ended May 28, 2022.

About Buckle

Offering a unique mix of high-quality, on-trend apparel, accessories, and footwear, Buckle caters to fashion-conscious young men and women. Known as a denim destination, each store carries a wide selection of fits, styles, and finishes from leading denim brands, including the Company’s exclusive brand, BKE. Headquartered in Kearney, Nebraska, Buckle currently operates 440 retail stores in 42 states. The Company operated 440 stores in 42 states as of June 1, 2022. To listen to the Company’s recorded monthly sales commentary, please call (308) 238-2500.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: All forward-looking statements made by the Company involve material risks and uncertainties and are subject to change based on factors which may be beyond the Company’s control. Accordingly, the Company’s future performance and financial results may differ materially from those expressed or implied in any such forward-looking statements. Such factors include, but are not limited to, those described in the Company’s filings with the Securities and Exchange Commission. The Company does not undertake to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized.

News releases and other information on The Buckle, Inc.

can be accessed at www.buckle.com.

Thomas B. Heacock, Chief Financial Officer

The Buckle, Inc.

(308) 236-8491

KEYWORDS: Nebraska United States North America

INDUSTRY KEYWORDS: Footwear Fashion Retail Consumer Women Teens Men

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NuScale Power to Participate in June 2023 Investor Conferences

NuScale Power to Participate in June 2023 Investor Conferences

PORTLAND, Ore.–(BUSINESS WIRE)–
NuScale Power Corporation (NYSE: SMR), the industry-leading provider of proprietary and innovative advanced small modular reactor nuclear technology, today announced that its management is scheduled to conduct one-on-one and small group meetings with institutional investors at several conferences in June 2023. Attendance at these conferences is by invitation only for clients of each respective firm. Interested investors should contact their respective sales representative to register and, for one-on-one meetings, secure a time.

  • June 6, 2023: TD Cowen Sustainability Week (Virtual)

  • June 7, 2023: Stifel Cross Sector Insight Conference in Boston, MA

  • June 15, 2023: Cantor Fitzgerald Technology Conference in New York, NY

  • June 22, 2023: JP Morgan Energy, Power & Renewables Conference in New York, NY

Please join the fireside webcast chats from TD Cowen Sustainability Week on June 6 at 1:45 p.m. ET and the JP Morgan Energy, Power & Renewables Conference on June 22 at 10:20 a.m. ET.

Access NuScale’s Events & Presentations page for webcast links to the fireside chats along with a complete list of conferences.

About NuScale Power

NuScale Power Corporation (NYSE: SMR) is the industry-leading provider of proprietary and innovative advanced small modular reactor nuclear technology, with a mission to help power the global energy transition by delivering safe, scalable, and reliable carbon-free energy. The company’s groundbreaking VOYGR™ SMR plants are powered by the NuScale Power Module™, a small, safe, pressurized water reactor that can each generate 77 megawatts of electricity (MWe) or 250 megawatts thermal (gross), and can be scaled to meet customer needs through an array of flexible configurations up to 924 MWe (12 modules) of output.

As the first and only SMR to have its design certified by the U.S. Nuclear Regulatory Commission, NuScale is well-positioned to serve diverse customers across the world by supplying nuclear energy for electrical generation, district heating, desalination, commercial-scale hydrogen production, and other process heat applications.

Founded in 2007, NuScale is headquartered in Portland, Ore. To learn more, visit NuScale Power’s website or follow us on Twitter, Facebook, LinkedIn, Instagramand YouTube.

Investor contact

Scott Kozak, Director, Investor Relations

[email protected]

Media contact

Diane Hughes, Vice President, Marketing & Communications

[email protected]

KEYWORDS: United States North America Massachusetts New York Oregon

INDUSTRY KEYWORDS: Nuclear Energy

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Ferguson plc (“Company”): Total Voting Rights

Ferguson plc (“Company”): Total Voting Rights

WOKINGHAM, England–(BUSINESS WIRE)–NOTIFICATION OF TOTAL VOTING RIGHTS AND CAPITAL IN THE COMPANY

In accordance with DTR 5.6.1, the Company hereby notifies the following:

The Company’s issued share capital as at May 31, 2023 consisted of 232,171,182 ordinary shares of 10 pence each (“Ordinary Shares”), of which 27,385,265 Ordinary Shares were held in treasury as at the date of this disclosure. The voting rights of treasury shares are automatically suspended.

Therefore, the total voting rights in the Company is 204,785,917. This figure may be used by shareholders as the denominator for the calculations by which to determine if they are required to notify their interest in, or a change to their interest in, the Company under the FCA’s Disclosure Guidance and Transparency Rules and the Company’s Articles of Association.

June 1, 2023

Enquiries:

Kate McCormick, Company Secretary

(0118 927 3827)

KEYWORDS: United Kingdom Europe

INDUSTRY KEYWORDS: Other Construction & Property Construction & Property Professional Services Finance

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FDA Approves LYNPARZA® (olaparib)Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

FDA Approves LYNPARZA® (olaparib)Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

LYNPARZA combination showed a clinically meaningful reduction in risk of disease progression or death in these patients in the Phase 3 PROpel trial

First approval of a PARP inhibitor in combination with a new hormonal agent in mCRPC

RAHWAY, N.J.–(BUSINESS WIRE)–
AstraZeneca and Merck (NYSE: MRK),known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59]) versus abi/pred alone in patients with BRCAm mCRPC. In the BRCAm subgroup (n=85), the median rPFS and OS were not reached (NR) in those receiving LYNPARZA plus abi/pred (95% CI, NR-NR for both rPFS and OS), compared to a median of eight months rPFS (95% CI, 6-15) and 23 months OS (95% CI, 18-34) in those receiving placebo plus abi/pred. As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796). Based on exploratory analyses of rPFS and OS in the BRCAm and non-BRCAm subgroups (non-BRCA subgroup rPFS HR=0.77 [95% CI, 0.63-0.96]; non-BRCA subgroup OS HR=0.92 [95% CI, 0.74-1.14]), the FDA concluded that the improvement in the ITT population was primarily attributed to the results seen in the subgroup of patients with BRCAm.

In the ITT population, the most common adverse reactions (ARs) in patients who received LYNPARZA plus abi/pred (≥10%) were anemia (48%), fatigue (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia and dizziness (14% each) and abdominal pain (13%). Among patients who received LYNPARZA in combination with abi/pred, 16% permanently discontinued treatment with LYNPARZA due to an AR, 48% had a dosage interruption of LYNPARZA and 21% had their dose of LYNPARZA reduced.

In the U.S., prostate cancer is the second most common cancer in men, and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low.Many patients with mCRPC are only able to receive one line of therapy, as the disease can progress quickly. Approximately 10% of patients with mCRPC will have BRCA mutations, which are associated with a poor prognosis and worse outcomes.

Andrew Armstrong, MD, ScM, Duke Cancer Institute, Durham, N.C. and an investigator in the trial, said, “Preventing or delaying radiographic progression is an important clinical endpoint in assessing cancer treatment and is very important to patients, their caregivers and their families. The PROpel results showed the LYNPARZA combination demonstrated a notable clinically meaningful benefit that should rapidly be considered as the standard of care treatment for patients with BRCAm mCRPC.”

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “There is a critical unmet need for new first-line treatment options for patients with BRCAm mCRPC, and this approval underscores the importance of BRCA testing at metastatic diagnosis. We look forward to bringing the benefit of this LYNPARZA combination to patients earlier in their treatment.”

Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “It is imperative that we create new ways to treat advanced cancers and help improve patient outcomes by building on the current standard of care. In PROpel, the LYNPARZA combination improved rPFS and OS for the subgroup of patients with BRCAm mCRPC. This approval reinforces the importance of routine testing for genetic mutations at metastatic diagnosis to help guide clinical decisions.”

The rPFS results from the ITT population of the Phase 3 PROpel trial were published in NEJM Evidence in June 2022.

LYNPARZA plus abi/pred is approved in several other countries for the treatment of appropriate adult patients with mCRPC based on the PROpel trial. In the European Union (EU), LYNPARZA plus abi/pred is approved for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated, regardless of biomarker status.

In the U.S., LYNPARZA was previously approved for patients with homologous recombination repair gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone, and in the EU, Japan and China for patients with BRCAm mCRPC who have progressed following prior therapy that included a new hormonal agent (NHA). These approvals were based on the data from the Phase 3 PROfound trial. For the U.S. indication, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

About PROpel

PROpel (ClinicalTrials.gov, NCT03732820) is a randomized, double-blind Phase 3 trial testing the efficacy, safety and tolerability of LYNPARZAversus placebo when given in addition to abi/pred in 796 patients with mCRPC who had not received prior chemotherapy or NHAs in the mCRPC setting. The major efficacy outcome was rPFS as assessed by investigator per RECIST v1.1 and Prostate Cancer Working Group (bone) criteria. Overall survival was an additional efficacy outcome measure. Exploratory subgroup analyses were subsequently conducted to assess efficacy in patients with BRCAm (n=85) and patients without identified BRCAm (n=711). BRCA-mutated status was assessed after randomization and before primary analysis by both next generation sequencing-based tumor tissue and circulating tumor DNA tests. BRCA-mutated classification criteria in line with the FDA-approved assays were used to determine the deleterious and suspected deleterious somatic or germline mutation status of patients. BRCA was not a stratification factor in PROpel, and the BRCAm and non-BRCAm subgroup analyses were not controlled for Type 1 error.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS/AML was 2 years (range: <6 months to >10 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Venous Thromboembolism (VTE): Including severe or fatal pulmonary embolism (PE) occurred in patients treated with LYNPARZA. In the combined data of two randomized, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%. In the control arms, VTE occurred in 2.5%, including pulmonary embolism in 1.5%. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab and at a ≥5% frequency compared to placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).

ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%).

ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in >25% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

ADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA/abiraterone with a difference of ≥5% compared to placebo for PROpel were: anemia (48%), fatigue (including asthenia) (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia (14%), dizziness (14%), and abdominal pain (13%). Most common laboratory abnormalities (Grades 1-4) in ≥20% of patients who received LYNPARZA/abiraterone for PROpel were: decrease in hemoglobin (97%), decrease in lymphocytes (70%), decrease in platelets (23%), and decrease in absolute neutrophil count (23%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:

  • a deleterious or suspected deleterious BRCA mutation, and/or

  • genomic instability

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Maintenance Recurrent Ovarian Cancer

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

gBRCAm, HER2-Negative Metastatic Breast Cancer

For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

BRCAm Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

In combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please see complete Prescribing Information, including Medication Guide.

Financial considerations

Under the oncology collaboration with AstraZeneca and following this new approval for LYNPARZA, AstraZeneca will receive a regulatory milestone payment from Merck.

AboutLYNPARZA® (olaparib)

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

About metastatic castration-resistant prostate cancer

Prostate cancer is the second most common cancer in male patients globally and is associated with a significant mortality rate. Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. In patients with mCRPC, their prostate cancer grows and spreads to other parts of the body, despite the use of androgen-deprivation therapy to block the action of male sex hormones.Approximately 10-20% of patients with prostate cancer are estimated to develop castration-resistant prostate cancer (CRPC) within five years, with at least 84% of these patients presenting with metastases at the time of CRPC diagnosis.Of patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years.

About BRCA mutations

BRCA1 and BRCA2 (breast cancer susceptibility genes 1/2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells. When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

Approximately 10% of patients with mCRPC will have BRCA mutations, which are associated with a poor prognosis and worse outcomes.

About the AstraZeneca and Merck strategic oncology collaboration

In July 2017, AstraZeneca and Merck, known as MSD outside of the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize certain oncology products including LYNPARZA, the world’s first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.

Merck’s focus on cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media:

Julie Cunningham, (617) 519-6264

Chrissy Trank, (640) 650-0694

Investor:

Peter Dannenbaum, (732) 594-1579

Damini Chokshi, (732) 594-1577

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Biotechnology General Health FDA Health Pharmaceutical

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TELUS International Appoints Jose-Luis Garcia as Chief Operating Officer to Lead Global Service Delivery Operations

TELUS International Appoints Jose-Luis Garcia as Chief Operating Officer to Lead Global Service Delivery Operations

Jose-Luis brings 30 years of experience leading service delivery operations in telecommunications, digital IT and tech sectors

Demonstrated excellence and focused expertise overseeing end-to-end digital transformations for complex, global enterprises

New COO will play a key role to further advance and evolve TELUS International’s global operational delivery model

VANCOUVER, British Columbia–(BUSINESS WIRE)–TELUS International,a leading digital customer experience (CX) innovator that designs, builds and delivers next-generation solutions, including artificial intelligence (AI) and content moderation, for global and disruptive brands, today announced the appointment of Jose-Luis Garcia as the company’s Chief Operating Officer (COO), effective today.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230601005344/en/

TELUS International appoints Jose-Luis Garcia as Chief Operating Officer to Lead Global Service Delivery Operations (Photo: Business Wire)

TELUS International appoints Jose-Luis Garcia as Chief Operating Officer to Lead Global Service Delivery Operations (Photo: Business Wire)

“On behalf of our more than 75,000 team members around the world, I am very pleased to welcome Jose-Luis to TELUS International at an exciting juncture in our company’s 18-year journey as we further integrate our operations on a global scale in order to best support our clients as they implement digital transformation initiatives, including through the provision of digital CX, generative AI and trust & safety services and solutions,” said Jeff Puritt, President and CEO, TELUS International. “Indeed, Jose-Luis’ proven track record as a successful global transformation agent for large, complex enterprises, his ability to connect science, technology and business, his long-standing passion and education in AI, and his strong operational and consulting background afford him a unique holistic view that will help us shape transformational outcomes customized to our clients’ needs. Additionally, his ability to lead high-performing teams through his commitment to team member engagement, training and reskilling, and learning and development is complementary to our organization’s foundational caring culture and values.”

“I am excited to be joining TELUS International and look forward to working with my new colleagues to support and further empower our global team to deliver exceptional solutions for our clients in their digital transformation evolutions as we continue to leverage the latest technologies to solve their pressing issues,” said Jose-Luis Garcia, Chief Operating Officer, TELUS International. “Together, we will unlock new opportunities, drive synergies and further strengthen our position in the marketplace through continuous innovation at speed, larger scale and a value driven growth mindset while maintaining our caring culture and empathy in everything we do. TELUS International’s dedication to making a positive impact in the regions where it operates also reflects the values I hold dear. I am proud to be part of an organization that recognizes the importance of community engagement and ESG initiatives, including volunteering and giving back where team members live and work.”

Jose-Luis has lived and worked around the world across five continents in various senior executive and partner roles with well-known technology, telecommunications and strategy and consulting firms. Now based in Madrid, Spain, Jose-Luis will lead TELUS International’s global operations in 32 countries across North America, Central America, Europe, Africa and Asia-Pacific.

About TELUS International

TELUS International (NYSE & TSX: TIXT) designs, builds and delivers next-generation digital solutions to enhance the customer experience (CX) for global and disruptive brands. The company’s services support the full lifecycle of its clients’ digital transformation journeys, enabling them to more quickly embrace next-generation digital technologies to deliver better business outcomes. TELUS International’s integrated solutions span digital strategy, innovation, consulting and design, IT lifecycle including managed solutions, intelligent automation and end-to-end AI data solutions including computer vision capabilities, as well as omnichannel CX and trust and safety solutions including content moderation. Fueling all stages of company growth, TELUS International partners with brands across strategic industry verticals, including tech and games, communications and media, eCommerce and fintech, banking, financial services and insurance, healthcare, and others.

TELUS International’s unique caring culture promotes diversity and inclusivity through its policies, team member resource groups and workshops, and equal employment opportunity hiring practices across the regions where it operates. Since 2007, the company has positively impacted the lives of more than 1.2 million citizens around the world, building stronger communities and helping those in need through large-scale volunteer events and charitable giving. Five TELUS International Community Boards have provided $5.2 million in funding to grassroots charitable organizations since 2011. Learn more at: telusinternational.com.

TELUS International Media Relations:

Ali Wilson

(604) 328-7093

[email protected]

TELUS International Investor Relations:

Jason Mayr

(604) 695-3455

[email protected]

KEYWORDS: United States North America Canada

INDUSTRY KEYWORDS: Software Consulting Artificial Intelligence Data Management Professional Services Technology Apps/Applications Other Technology

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TELUS International appoints Jose-Luis Garcia as Chief Operating Officer to Lead Global Service Delivery Operations (Photo: Business Wire)

WEX to Host Benefits Investor Event Today

WEX to Host Benefits Investor Event Today

PORTLAND, Maine–(BUSINESS WIRE)–WEX (NYSE: WEX), the global commerce platform that simplifies the business of running a business, will host its previously announced Benefits Investor Event today beginning at 3:30 p.m. ET and concluding at approximately 4:30 p.m. ET. Melissa Smith, WEX’s Chair, Chief Executive Officer, and President, and other members of the WEX leadership team will provide an in-depth review of the Benefits segment, including the product set, growth drivers, and financial profile.

Webcast Details

Investors and other interested parties can register to attend virtually at https://wex-benefits-ir-event-virtual.open-exchange.net/registration. The accompanying slide presentation will be accessible by visiting the Investor Relations section of the WEX website at https://ir.wexinc.com approximately one hour prior to the event. A replay will also be available on the WEX website following the event for no fewer than three months.

About WEX

WEX (NYSE: WEX) is the global commerce platform that simplifies the business of running a business. WEX has created a powerful ecosystem that offers seamlessly embedded, personalized solutions for its customers around the world. Through its rich data and specialized expertise in simplifying benefits, reimagining mobility and paying and getting paid, WEX aims to make it easy for companies to overcome complexity and reach their full potential. For more information, please visit www.wexinc.com.

News media:

WEX

Julie Lydon, 415-816-9397

[email protected]

Investor:

WEX

Steve Elder, 207-523-7769

[email protected]

KEYWORDS: Maine United States North America

INDUSTRY KEYWORDS: Technology Electronic Commerce Professional Services Business

MEDIA:

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Maritime Cleantech Company Selects Spire Global to Provide Ship-Tracking Data

Maritime Cleantech Company Selects Spire Global to Provide Ship-Tracking Data

VIENNA, Va.–(BUSINESS WIRE)–Spire Global, Inc. (NYSE: SPIR) (“Spire” or “the Company”), a global provider of space-based data, analytics and space services, was selected by Navidium, an innovative software company active in the maritime industry, to provide real-time automatic identification system (AIS) vessel-tracking data.

Navidium will integrate the data into its Voyage Optimization & Environmental Compliance products to help users track vessel position along a route, reoptimize routes based on various conditions and automatically record environmental compliance data, such as Carbon Intensity Indicator (CII). This product supports crew onboard a vessel, along with fleet managers on shore who need to be aware of their fleet’s current position and progress through a planned journey.

Navidium is also leveraging Spire’s historical and real-time AIS data to train machine learning algorithms that provide users with insights to augment decision making and optimize their vessels for safety, emissions and performance, giving them an edge in a highly competitive environment.

“Working with a flexible solution provider like Spire allows us to adjust quickly to our customers’ needs and gather very meaningful data that we can use to bring a lot of value to our customers,” said Marty Cochrane, Navidium CTO.

Navidium is part of over 1,000 SME and start-up companies in the maritime space, a number that has been growing steadily in the double digits.

About Spire Global, Inc.

Spire (NYSE: SPIR) is a global provider of space-based data, analytics and space services, offering unique datasets and powerful insights about Earth so that organizations can make decisions with confidence in a rapidly changing world. Spire builds, owns, and operates a fully deployed satellite constellation that observes the Earth in real time using radio frequency technology. The data acquired by Spire’s satellites provides global weather intelligence, ship and plane movements, and spoofing and jamming detection to better predict how their patterns impact economies, global security, business operations, and the environment. Spire also offers Space as a Service solutions that empower customers to leverage its established infrastructure to put their business in space. Spire has eight offices across the U.S., Canada, UK, Luxembourg and Singapore. To learn more, visit spire.com.

For Media:

Kristina Spychalski

Director of Communications

[email protected]

For Investors:

Benjamin Hackman

Head of Investor Relations

[email protected]

KEYWORDS: United States North America Virginia

INDUSTRY KEYWORDS: Data Management Technology Professional Services Maritime Transport Satellite Green Technology Data Analytics Software Artificial Intelligence Environment

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Caleres Reports First Quarter 2023 Results

Caleres Reports First Quarter 2023 Results

  • Delivers $0.97 in earnings per share, the upper end of previous guidance
  • Generates record quarterly operating earnings and operating margin in the Brand Portfolio segment
  • Reiterates full year fiscal 2023 adjusted earnings per share guidance
  • Reduces revolving credit facility borrowings by $16 million from fiscal year-end 2022
  • Announces strategic expense reduction initiatives

ST. LOUIS–(BUSINESS WIRE)–
Caleres (NYSE: CAL), a diverse portfolio of consumer-driven footwear brands, today reported financial results for the first quarter of 2023, and reiterated its full year fiscal 2023 earnings per share outlook.

“The Caleres team delivered a solid financial performance at the upper end of our earnings per share guidance driven by record quarterly profit from the Brand Portfolio and despite a challenging operating environment at Famous Footwear,” said Jay Schmidt, president and chief executive officer. “These first quarter results underscore the value of our diversified structure, the strength of our omnichannel capabilities and the power of our portfolio.”

First Quarter 2023 Results

(13-weeks ended April 29, 2023, compared to 13-weeks ended April 30, 2022)

  • Net sales were $662.7 million, down 9.8 percent from the first quarter of 2022;

    • Famous Footwear segment sales declined 9.2 percent, with comparable sales down 8.5 percent, due to soft consumer demand in shoe chains.

    • Brand Portfolio segment sales decreased 11.0 percent, in-line with expectations and primarily due to the timing of wholesale shipments in the Brand Portfolio in first quarter of 2022 to satisfy customer restocking efforts.

    • Direct-to-consumer sales represented approximately 68 percent of total net sales.

  • Gross profit was $302.7 million, while gross margin was 45.7 percent;

    • Famous Footwear segment gross margin of 45.6 percent

    • Brand Portfolio segment gross margin of 44.2 percent

  • SG&A as a percentage of net sales was 38.2 percent;

  • Net earnings of $34.7 million, or earnings per diluted share of $0.97, compared to net earnings of $50.5 million, or earnings per diluted share of $1.32 in the first quarter of 2022;

  • Earnings before interest, taxes, depreciation, and amortization (EBITDA) of $63.7 million, or 9.6 percent of sales;

  • Inventory was down 13.1 percent compared to first quarter of 2022, reflecting the company’s disciplined approach to inventory management and lower in-transit inventory; and

  • Borrowings under the asset-based revolving credit facility were $291.5 million at the end of the quarter.

Capital Allocation Update

In line with its capital allocation priorities, Caleres continued to reduce the borrowings under its asset-based revolving credit facility, paying down $16 million during the first quarter of 2023. The company also invested $6.5 million in capital expenditures and returned $2.5 million to shareholders through its quarterly dividend. The Caleres board of directors recently approved its next quarterly dividend, which will be paid on June 28, 2023, to shareholders of record as of June 9, 2023.

Fiscal 2023 Outlook:

“Looking ahead, we are encouraged by the increased financial contribution from the Brand Portfolio and the strong momentum in our lead brands – Sam Edelman, Vionic, Naturalizer and Allen Edmonds,” said Schmidt. “While we expect near-term pressure to persist at Famous Footwear, we are highly confident in our ability to remain the leader in footwear for the family, which we believe plays an essential role in the footwear sector overall.”

As a result of the more challenging operating environment, Caleres has taken several steps to reduce expenses across its business. These actions include eliminating open corporate positions, reducing non-merchandise procurement costs, realizing additional Brand Portfolio synergies, and lowering depreciation expense, and are expected to result in $20 million of in-year savings. The company also anticipates better-than-expected freight costs, which is expected to be an additional $10 million in savings. These cost savings are versus prior guidance assumptions, some of which were realized in the first quarter. Caleres anticipates a one-time cash charge of approximately $4 million in the second quarter of 2023 associated with these actions. Additionally, the company anticipates gross margin strength in the Brand Portfolio segment for the balance of the year.

For fiscal 2023, the company is expecting full year diluted earnings per share of $4.02 to $4.22, inclusive of the $4 million one-time charge associated with expense reduction actions in the second quarter. The company is reiterating its full year diluted adjusted earnings per share range of $4.10 to $4.30 and updating its consolidated net sales range to be down 3 percent to down 5 percent. This topline adjustment reflects the company’s revised sales expectations at Famous Footwear.

In addition, Caleres now expects:

  • Consolidated operating margin of 7.3 percent to 7.5 percent, versus previous guidance of 7.1 percent to 7.3 percent;

  • Interest expense of $17 million to $19 million, versus previous guidance of $18 million to $20 million; and

  • Capital expenditures of $55 million to $65 million, versus previous guidance of $60 million to $70 million.

The company still expects an effective tax rate of about 25 percent and weighted average shares outstanding of 34.3 million.

For second quarter of 2023 the company expects:

  • Consolidated net sales down 4 percent to 5 percent;

  • Diluted earnings per share of $0.79 to $0.84; and

  • Adjusted diluted earnings per share of $0.87 to $0.92.

“As we progress through 2023, we are focused on tightly managing our expenses, investing in value-enhancing opportunities, and maximizing our capabilities to position the organization for growth,” said Schmidt. “We believe we have the right foundation and strategic initiatives in place to consistently deliver annual earnings per share of more than $4.00 as we generate strong levels of free cash flow and create value for our shareholders.”

Investor Conference Call

Caleres will host a conference call at 10:00 a.m. ET today, Thursday, June 1. The webcast and associated slides will be available at investor.caleres.com/news/events. A live conference call will be available at (877) 704-4453 for North America participants or (201) 389-0920 for international participants, no passcode necessary. A replay will be also available at investor.caleres.com/news/events/archive for a limited period. Investors may also access the replay by dialing (844) 512-2921 in North America or (412) 317-6671 internationally and using the conference pin 13738707.

Definitions

All references in this press release, outside of the condensed consolidated financial statements that follow, unless otherwise noted, related to net earnings attributable to Caleres, Inc. and diluted earnings per common share attributable to Caleres, Inc. shareholders, are presented as net earnings and earnings per diluted share, respectively.

Non-GAAP Financial Measures

In this press release, the company’s financial results are provided both in accordance with generally accepted accounting principles (GAAP) and using certain non-GAAP financial measures. In particular, the company provides earnings before interest, taxes, depreciation and amortization, and estimated future earnings per diluted share adjusted to exclude certain gains, charges, and recoveries, which are non-GAAP financial measures. These results are included as a complement to results provided in accordance with GAAP because management believes these non-GAAP financial measures help identify underlying trends in the company’s business and provide useful information to both management and investors by excluding certain items that may not be indicative of the company’s core operating results. These measures should not be considered a substitute for or superior to GAAP results.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995

This press release contains certain forward-looking statements and expectations regarding the company’s future performance and the performance of its brands. Such statements are subject to various risks and uncertainties that could cause actual results to differ materially. These risks include (i) inflationary pressures; (ii) supply chain disruptions (iii) changing consumer demands, which may be influenced by general economic conditions and other factors; (iv) rapidly changing consumer preferences and purchasing patterns and fashion trends; (v) customer concentration and increased consolidation in the retail industry; (vi) intense competition within the footwear industry; (vii) foreign currency fluctuations; (viii) political and economic conditions or other threats to the continued and uninterrupted flow of inventory from China and other countries, where the company relies heavily on third-party manufacturing facilities for a significant amount of its inventory; (ix) cybersecurity threats or other major disruption to the company’s information technology systems; (x) the ability to accurately forecast sales and manage inventory levels; (xi) a disruption in the company’s distribution centers; (xii) the ability to recruit and retain senior management and other key associates; (xiii) the ability to secure/exit leases on favorable terms; (xiv) the ability to maintain relationships with current suppliers; (xv) transitional challenges with acquisitions and divestitures; (xvi) changes to tax laws, policies and treaties; (xvii) our commitments and shareholder expectations related to environmental, social and governance considerations; (xviii) compliance with applicable laws and standards with respect to labor, trade and product safety issues; and (xix) the ability to attract, retain, and maintain good relationships with licensors and protect our intellectual property rights. The company’s reports to the Securities and Exchange Commission contain detailed information relating to such factors, including, without limitation, the information under the caption Risk Factors in Item 1A of the company’s Annual Report on Form 10-K for the year ended January 28, 2023, which information is incorporated by reference herein and updated by the company’s Quarterly Reports on Form 10-Q. The company does not undertake any obligation or plan to update these forward-looking statements, even though its situation may change.

 

SCHEDULE 1

 

CALERES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

Thirteen Weeks Ended

($ thousands, except per share data)

 

April 29, 2023

 

April 30, 2022

Net sales

 

$

662,734

 

 

$

735,116

 

Cost of goods sold

 

 

360,052

 

 

 

408,122

 

Gross profit

 

 

302,682

 

 

 

326,994

 

Selling and administrative expenses

 

 

253,095

 

 

 

260,799

 

Operating earnings

 

 

49,587

 

 

 

66,195

 

Interest expense, net

 

 

(5,623

)

 

 

(2,299

)

Other income, net

 

 

1,492

 

 

 

3,422

 

Earnings before income taxes

 

 

45,456

 

 

 

67,318

 

Income tax provision

 

 

(10,664

)

 

 

(17,333

)

Net earnings

 

 

34,792

 

 

 

49,985

 

Net earnings (loss) attributable to noncontrolling interests

 

 

65

 

 

 

(524

)

Net earnings attributable to Caleres, Inc.

 

$

34,727

 

 

$

50,509

 

 

 

 

 

 

 

 

Basic earnings per common share attributable to Caleres, Inc. shareholders

 

$

0.97

 

 

$

1.34

 

 

 

 

 

 

 

 

Diluted earnings per common share attributable to Caleres, Inc. shareholders

 

$

0.97

 

 

$

1.32

 

SCHEDULE 2

 

CALERES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

 

 

 

 

 

 

(Unaudited)

($ thousands)

 

April 29, 2023

 

April 30, 2022

ASSETS

 

 

 

 

 

 

Cash and cash equivalents

 

$

36,151

 

$

33,717

Receivables, net

 

 

148,068

 

 

181,551

Inventories, net

 

 

559,467

 

 

643,527

Property and equipment, held for sale

 

 

16,777

 

 

16,777

Prepaid expenses and other current assets

 

 

60,417

 

 

58,069

Total current assets

 

 

820,880

 

 

933,641

 

 

 

 

 

 

 

Lease right-of-use assets

 

 

513,817

 

 

503,393

Property and equipment, net

 

 

157,730

 

 

137,600

Goodwill and intangible assets, net

 

 

212,353

 

 

224,475

Other assets

 

 

113,303

 

 

129,189

Total assets

 

$

1,818,083

 

$

1,928,298

 

 

 

 

 

 

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

Borrowings under revolving credit agreement

 

$

291,500

 

$

305,000

Trade accounts payable

 

 

261,753

 

 

386,821

Lease obligations

 

 

136,297

 

 

118,692

Other accrued expenses

 

 

189,727

 

 

259,374

Total current liabilities

 

 

879,277

 

 

1,069,887

 

 

 

 

 

 

 

Noncurrent lease obligations

 

 

437,171

 

 

452,742

Other liabilities

 

 

49,754

 

 

47,641

Total other liabilities

 

 

486,925

 

 

500,383

 

 

 

 

 

 

 

Total Caleres, Inc. shareholders’ equity

 

 

446,317

 

 

352,236

Noncontrolling interests

 

 

5,564

 

 

5,792

Total equity

 

 

451,881

 

 

358,028

Total liabilities and equity

 

$

1,818,083

 

$

1,928,298

SCHEDULE 3

 

CALERES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

Thirteen Weeks Ended

($ thousands)

 

April 29, 2023

 

April 30, 2022

OPERATING ACTIVITIES:

 

 

 

 

 

 

Net cash provided by operating activities

 

$

37,497

 

 

$

19,686

 

 

 

 

 

 

 

 

INVESTING ACTIVITIES:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(5,750

)

 

 

(9,305

)

Capitalized software

 

 

(798

)

 

 

(2,345

)

Net cash used for investing activities

 

 

(6,548

)

 

 

(11,650

)

 

 

 

 

 

 

 

FINANCING ACTIVITIES:

 

 

 

 

 

 

Borrowings under revolving credit agreement

 

 

126,000

 

 

 

205,000

 

Repayments under revolving credit agreement

 

 

(142,000

)

 

 

(190,000

)

Dividends paid

 

 

(2,482

)

 

 

(2,648

)

Acquisition of treasury stock

 

 

 

 

 

(14,673

)

Issuance of common stock under share-based plans, net

 

 

(10,006

)

 

 

(3,599

)

Contributions by noncontrolling interests

 

 

 

 

 

1,500

 

Net cash used for financing activities

 

 

(28,488

)

 

 

(4,420

)

Effect of exchange rate changes on cash and cash equivalents

 

 

(10

)

 

 

(14

)

Increase in cash and cash equivalents

 

 

2,451

 

 

 

3,602

 

Cash and cash equivalents at beginning of period

 

 

33,700

 

 

 

30,115

 

Cash and cash equivalents at end of period

 

$

36,151

 

 

$

33,717

 

 

SCHEDULE 4

 

 

 

 

 

 

 

 

 

CALERES, INC.

SUMMARY FINANCIAL RESULTS BY SEGMENT

 

 

 

 

 

 

 

 

 

SUMMARY FINANCIAL RESULTS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

Thirteen Weeks Ended

 

 

Famous Footwear

Brand Portfolio

Eliminations and Other

Consolidated

 

 

April 29,

April 30,

April 29,

April 30,

April 29,

April 30,

April 29,

April 30,

($ thousands)

 

2023

2022

2023

2022

2023

2022

2023

2022

Net sales

 

$

349,158

 

$

384,502

 

$

325,516

 

$

365,740

 

$

(11,940

)

$

(15,126

)

$

662,734

 

$

735,116

 

Gross profit

 

 

159,133

 

 

189,234

 

 

143,858

 

 

139,299

 

 

(309

)

 

(1,539

)

 

302,682

 

 

326,994

 

Gross margin

 

 

45.6

%

 

49.2

%

 

44.2

%

 

38.1

%

 

2.6

%

 

10.2

%

 

45.7

%

 

44.5

%

Operating earnings (loss)

 

 

17,056

 

 

49,688

 

 

42,669

 

 

41,349

 

 

(10,138

)

 

(24,842

)

 

49,587

 

 

66,195

 

Operating margin

 

 

4.9

%

 

12.9

%

 

13.1

%

 

11.3

%

 

n/m

%

 

n/m

%

 

7.5

%

 

9.0

%

Comparable sales % (on a 13-week basis)

 

 

(8.5

)%

 

(4.0

)%

 

9.4

%

 

66.0

%

 

%

 

%

 

%

 

%

Number of stores

 

 

866

 

 

887

 

 

93

 

 

83

 

 

 

 

 

 

959

 

 

970

 

 

n/m – Not meaningful

SCHEDULE 5

 

CALERES, INC.

BASIC AND DILUTED EARNINGS PER SHARE RECONCILIATION

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

Thirteen Weeks Ended

 

 

April 29,

 

April 30,

 

 

2023

 

2022

($ thousands, except per share data)

 

 

 

 

 

 

Net earnings attributable to Caleres, Inc.:

 

 

 

 

 

 

Net earnings

 

$

34,792

 

 

$

49,985

 

Net (earnings) loss attributable to noncontrolling interests

 

 

(65

)

 

 

524

 

Net earnings attributable to Caleres, Inc.

 

 

34,727

 

 

 

50,509

 

Net earnings allocated to participating securities

 

 

(1,478

)

 

 

(2,017

)

Net earnings attributable to Caleres, Inc. after allocation of earnings to participating securities

 

$

33,249

 

 

$

48,492

 

 

 

 

 

 

 

 

Basic and diluted common shares attributable to Caleres, Inc.:

 

 

 

 

 

 

Basic common shares

 

 

34,407

 

 

 

36,209

 

Dilutive effect of share-based awards

 

 

 

 

 

467

 

Diluted common shares attributable to Caleres, Inc.

 

 

34,407

 

 

 

36,676

 

 

 

 

 

 

 

 

Basic earnings per common share attributable to Caleres, Inc. shareholders

 

$

0.97

 

 

$

1.34

 

 

 

 

 

 

 

 

Diluted earnings per common share attributable to Caleres, Inc. shareholders

 

$

0.97

 

 

$

1.32

 

SCHEDULE 6

 

CALERES, INC.

CALCULATION OF EBITDA (NON-GAAP METRIC)

 

 

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

Thirteen Weeks Ended

($ thousands)

 

April 29, 2023

 

April 30, 2022

EBITDA:

 

 

 

 

 

 

 

 

Net earnings attributable to Caleres, Inc.

 

$

34,727

 

 

$

50,509

 

Income tax provision

 

 

10,664

 

 

 

17,333

 

Interest expense, net

 

 

5,623

 

 

 

2,299

 

Depreciation and amortization (1)

 

 

12,714

 

 

 

12,357

 

EBITDA

 

$

63,728

 

 

$

82,498

 

 

 

 

 

 

 

 

 

 

EBITDA margin

 

 

9.6

%

 

 

11.2

%

__________________________

 (1)

Includes depreciation and amortization of capitalized software and intangible assets.

SCHEDULE 7

 

CALERES, INC.

RECONCILIATION OF DILUTED EARNINGS PER SHARE (GAAP BASIS) TO ADJUSTED DILUTED EARNINGS PER SHARE (NON-GAAP BASIS) – SECOND QUARTER AND FISCAL 2023 GUIDANCE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

Second Quarter 2023 Guidance

 

Fiscal 2023 Guidance

 

 

Low

 

High

 

Low

 

High

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP diluted earnings per share

 

$

0.79

 

$

0.84

 

$

4.02

 

$

4.22

Charges/other items:

 

 

 

 

 

 

 

 

 

 

 

 

Expense reduction initiatives

 

 

0.08

 

 

0.08

 

 

0.08

 

 

0.08

Adjusted diluted earnings per share

 

$

0.87

 

$

0.92

 

$

4.10

 

$

4.30

 

Investor Contact:

Logan Bonacorsi

[email protected]

KEYWORDS: Missouri United States North America

INDUSTRY KEYWORDS: Footwear Fashion Online Retail Retail Department Stores Manufacturing Textiles

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Air Lease Corporation Announces Lease Placement of Four New Airbus A220 Aircraft with Czech Airlines

Air Lease Corporation Announces Lease Placement of Four New Airbus A220 Aircraft with Czech Airlines

LOS ANGELES–(BUSINESS WIRE)–
Today Air Lease Corporation (NYSE: AL) announced long-term lease placements for four new Airbus A220-300 aircraft with Czech Airlines. All four aircraft are scheduled to deliver to the European airline in 2024 from ALC’s order book with Airbus.

“We are pleased to announce this lease placement for four new Airbus A220 aircraft with Czech Airlines,” said Steven Udvar-Házy, Executive Chairman of Air Lease Corporation. “As the first to introduce the A220 to the airline, ALC looks forward to working with Czech Airlines long-term to modernize and enhance the airline’s fleet with the most technologically advanced and fuel-efficient new aircraft.”

Petr Kudela, Chairman of the Board of Directors, Czech Airlines, added: “These ALC A220s will greatly enhance our airline’s operational strength as we modernize our fleet with highly efficient and environmentally friendly single-aisle aircraft. Czech Airlines is pleased to launch the cooperation with the ALC team at the time we celebrate our 100th anniversary in October 2023. Thanks to a brand-new cabin configuration, the aircraft offers best in class comfort for short- and medium-haul flights. I am, therefore, convinced that this step will be appreciated particularly by our customers.”

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including expected delivery dates. Such statements are based on current expectations and projections about our future results, prospects and opportunities and are not guarantees of future performance. Such statements will not be updated unless required by law. Actual results and performance may differ materially from those expressed or forecasted in forward-looking statements due to a number of factors, including those discussed in our filings with the Securities and Exchange Commission.

About Air Lease Corporation (NYSE: AL)

Air Lease Corporation is a leading global aircraft leasing company based in Los Angeles, California that has airline customers throughout the world. ALC and its team of dedicated and experienced professionals are principally engaged in purchasing new commercial aircraft and leasing them to its airline customers worldwide through customized aircraft leasing and financing solutions. The company routinely posts information that may be important to investors in the “Investors” section of its website at www.airleasecorp.com. Investors and potential investors are encouraged to consult Air Lease Corporation’s website regularly for important information. The information contained on, or that may be accessed through, ALC’s website is not incorporated by reference into, and is not a part of, this press release.

About Czech Airlines

Czech Airlines is the Czech Republic’s flag carrier. Founded in 1923, it ranks among the five oldest airlines in the world. The Company specializes in regular passenger air transport, focusing primarily on direct scheduled connections between Prague and important destinations in Europe. Being a member of the SkyTeam global airline alliance and cooperating with its partner airlines, Czech Airlines offers its customers a wide range of destinations, daily frequencies and connecting services around the world.

Investors:

Jason Arnold

Vice President, Investor Relations

Email: [email protected]

Media:

Laura Woeste

Senior Manager, Media and Investor Relations

Email: [email protected]

Ashley Arnold

Manager, Media and Investor Relations

Email: [email protected]

KEYWORDS: California Europe Czech Republic United States North America

INDUSTRY KEYWORDS: Professional Services Air Transport Aerospace Manufacturing Finance

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