On July 29, 2021 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has priced its previously announced underwritten public offering of $1,800,000,000 aggregate principal amount of senior notes (Press release, Centene , JUL 29, 2021, View Source [SID1234585408]). The $1,800,000,000 offering of senior notes will include $500,000,000 aggregate principal amount of additional 2.450% senior notes due 2028 (the "Additional 2028 Notes") at a premium to yield 2.31% and $1,300,000,000 aggregate principal amount of new 2.625% senior notes due 2031 (together with the Additional 2028 Notes, the "Notes"). The Additional 2028 Notes will have the same terms as the Company’s existing 2.450% senior notes due 2028 (the "Existing 2028 Notes"), other than the issue date and the issue price. The offering is expected to close on or about August 12, 2021, subject to customary closing conditions.

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Centene intends to use the net proceeds from the offering of the Notes, together with a portion of the proceeds of certain term loans under the Company’s proposed amended and restated credit agreement and cash on hand to redeem all of its outstanding 5.375% senior notes due 2026 and all of WellCare Health Plans, Inc.’s, a Delaware corporation and a wholly-owned subsidiary of the Company, outstanding 5.375% senior notes due 2026 (together, the "Note Redemptions"), including all premiums, accrued interest and costs and expenses related to the Note Redemptions. Pending the application of the net proceeds of the offering for the foregoing purposes, net proceeds may be temporarily used for general corporate purposes. The foregoing does not constitute a notice of redemption or an obligation to issue a notice of redemption for the outstanding notes of any series.

The Notes will be senior unsecured obligations of the Company and will be equal in right of payment with all of the Company’s existing and future senior indebtedness and will be senior in right of payment to all of the Company’s existing and future subordinated debt. The Notes will not be guaranteed by any of the Company’s subsidiaries.

J.P. Morgan, Barclays, BofA Securities, Truist Securities and Wells Fargo Securities are acting as joint book-running managers for the offering of the Notes.

This offering is being made pursuant to an effective shelf registration statement and prospectus and a related preliminary prospectus supplement filed by the Company with the Securities and Exchange Commission (the "SEC"). Before you invest, you should read the prospectus and the related preliminary prospectus supplement, the registration statement and other documents that Centene has filed with the SEC for more complete information about Centene and this offering.

Copies of the prospectus supplement and related prospectuses for this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling +1 (866) 803-9204; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by calling (888) 603-5847; from BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; from Truist Securities by email at [email protected]; and from Wells Fargo Securities, LLC, 550 S. Tryon Street, 5th Floor, Charlotte, North Carolina 28202, Attention: Leveraged Syndicate.

This press release is neither an offer to purchase nor a solicitation of an offer to buy any securities, including the Notes. There shall not be any sale of the securities described herein in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On July 29, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported the publication of data from its Phase 1b OVATION 1 Study with GEN-1 in combination with neoadjuvant chemotherapy (NACT) in patients with advanced ovarian cancer in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Celsion, JUL 29, 2021, View Source [SID1234585425]). The study, authored by Premel H. Thaker, et al. is titled "GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-Escalation Study." The publication is available here.

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GEN-1 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in Phase I/II clinical development for the localized treatment of advanced ovarian cancer (the OVATION 2 Study). GEN-1 is an immunotherapy that produces safe and durable local levels of IL-12, a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 gene and a synthetic polymer facilitating plasmid delivery vector. Premal H. Thaker, M.D., M.S., Professor of Gynecologic Oncology and Director of Gynecologic Oncology Clinical Research at the Washington University School of Medicine at Washington University Medical Center in St. Louis, is the study chair for the OVATION program.

The OVATION 1 Study enrolled 18 patients with newly diagnosed stage IIIC and IV epithelial ovarian cancer in a standard 3+3 dose-escalation design testing four GEN-1 doses (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79mg/m2) in combination with NACT (carboplatin-paclitaxel). There were 15 patients evaluable for safety, and 14 underwent interval debulking and were evaluable for Response Evaluation Criteria in Solid Tumors (RECIST).

As previously reported, there were no dose-limiting toxicities. As shown in the chart below, in the two highest doses of GEN-1 the objective response rate was 100% and the R0 resection rate was 88%. Newly published data show the chemotherapy response score (CRS), which is analyzed in this paper for the first time, was 50% in the two highest doses of GEN-1, compared with 28% from a major publication evaluating CRS scoring. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental examination. Like R0 resection rates, CRS 3 response is believed to be a predictor of progression-free survival.

Clinical Responses: Tumor Response, Surgical Outcome, Pathological Response and Chemotherapy Response Score with NAC/GEN-1 escalating doses

Radiographic Response Total (n) Cohort 1
36 mg/m2 Cohort 2
47 mg/m2 Cohort 3
61 mg/m2 Cohort 4
79 mg/m2
Tumor Response

CR 2 1 0 0 1
PR 10 0 3 3 4
SD 2 2 0 0 0
Objective Response Rate 67 % 100 %
Surgical Outcome

R0 9 2 0 2 5
R1 3 1 2 0 0
R2 2 0 1 1 0
R0 Resection Rate 33 % 88 %
Pathological Response

cPR 1 1 0 0 0
Micro 8 1 2 1 4
Macro 5 1 1 2 1
cPR/Micro Rate 60 % 63 %
Chemotherapy
Response
Score

CRS 3 5 1 0 2 2
CRS 2 5 2 1 0 2
CRS 1 4 0 2 1 1
CRS 3 Rate 17 % 50 %
Commenting on the abstract, Dr. Thaker said, "My colleagues and I are very encouraged by the data generated from the OVATION 1 Study, which is informing the ongoing Phase I/II OVATION 2 Study. Importantly, the repeated durable increase in lL-12 and IFN-γ levels at the tumor site for an eight-week treatment period provides for a pharmacologic remodeling of the tumor microenvironment. These immunomodulatory effects of GEN-1 may result in an increased sensitivity of tumor microenvironment to other anticancer agents including cytotoxic drugs and immunotherapies such as checkpoint inhibitors and adaptive T cell therapies. The OVATION 2 Study of concurrent GEN-1 at a dose of 100 mg/m2 weekly for up to 17 doses administered during chemotherapy is actively recruiting."

Translational Responses: IL-12 and IFN-γ Levels, Response to Immune-Suppressive Agents; Ratio of CD8+ cells to Immune Suppressive Agents

Results from translational studies show the following:

A dose-dependent increase in immunostimulatory cytokines IL-12 and its downstream cytokine IFN-γ in ascitic fluid. The anticancer effects of these cytokines are widely recognized in human malignancies.
The proportion of myeloid dendritic cells in the peritoneal fluid trended higher (3.1-fold) accompanied by a similar 3.0-fold rise in CD8+ cells.
GEN-1 appeared to reduce four immunosuppressive signals (Foxp3, IDO1, PD-1 and PD-L1) within the tumor microenvironment, a trend not seen with NAC therapy alone.
GEN-1 also appeared to stimulate the body’s immune system through the production of CD4 and CD8 cells.
GEN-1 gene therapy was associated with an apparent increase in the cytotoxic state of T cells within the tumor microenvironment as indicated by the increases in the ratios of CD8+/CD4+ and CD8+/Treg cells. Indeed, higher CD8+/CD4+ T cell and CD8+/Treg ratios are considered prognostic for prolonged survival.
Junko Matsuzaki, Ph.D., Director of the Immune Analysis Facility at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y. and a study author, said, "The results from our translational studies show the activation of a multitude of immune responses following GEN-1 + NAC treatment. The multifactorial nature of GEN-1 immune response built on a durable local production of IL-12 may be activating the innate and adaptive immune system creating a unique microenvironment potentially favorable to anti-tumor responses and also conducive to other therapeutic drugs that may be suboptimal as single agents due to the highly immunosuppressive tumor microenvironment in ovarian cancer. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation."

Nicholas Borys, M.D., Chief Medical Officer of Celsion, said, "We are delighted that our OVATION 1 Study has been published in the Journal of Clinical Cancer Research. As patients with advanced ovarian cancer have a poor prognosis, these data are particularly encouraging. We believe this publication will create additional awareness of the work we are doing to treat these patients and provide them with new hope. While we know that R0 resection scores are important to survival and that GEN-1 has exhibited impressive R0 scores, its ability to improve CRS is also compelling. Adding GEN-1 to standard neoadjuvant chemotherapy is safe, appears to be clinically active with translational data suggesting a positive impact on the tumor microenvironment."

About the Journal of Clinical Cancer Research

The Journal of Clinical Cancer Research is a publication of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). It publishes innovative clinical and translational cancer research studies that bridge the laboratory and the clinic. The Journal is especially interested in clinical trials evaluating new treatments, accompanied by research on pharmacology, and molecular alterations or biomarkers that predict response or resistance to treatment. The Journal also prioritizes laboratory and animal studies of new drugs and molecule-targeted agents with the potential to lead to clinical trials, and studies of targetable mechanisms of oncogenesis, progression of the malignant phenotype and metastatic disease.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the 5th deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced stages III and IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, stage III and IV) after surgery and chemotherapy. Since the 5-year survival rates of patients with stages III and IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for regional approach to immune modulation.

On July 29, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company, leader in red blood-cell based cancer therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted eryaspase Fast Track designation for the treatment of acute lymphocytic leukemia (ALL) patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase (PEG-ASNase) (Press release, ERYtech Pharma, JUL 29, 2021, View Source [SID1234585452]).

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On July 29, 2021 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2021 (Press release, MacroGenics, JUL 29, 2021, View Source [SID1234585360]).

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"In June, we presented encouraging data from a Phase 1 study of MGC018 at ASCO (Free ASCO Whitepaper). We look forward to providing further updates on this compound and margetuximab in gastric cancer at ESMO (Free ESMO Whitepaper) in September. Beyond these two programs, we continue to progress our growing pipeline of investigational therapeutics for the potential treatment of cancer as well as to execute on the recent launch and commercialization of MARGENZA with our partner, EVERSANA," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Also in June, we announced our broad strategic collaboration with Zai Lab to develop and commercialize preclinical bispecific antibodies in oncology. We’re very pleased to have entered this second collaboration with Zai Lab."

Key Updates on Proprietary Programs

Recent progress and anticipated events in 2021 related to MacroGenics’ approved product, MARGENZA, and its investigational product candidates in clinical development are highlighted below.

Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.
MARGENZA (margetuximab-cmkb) commercial launch. In March 2021, MacroGenics and its commercial partner, EVERSANA, launched MARGENZA for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Based on the accrued overall survival (OS) events in the SOPHIA metastatic breast cancer Phase 3 study, the Company expects to complete and share top-line results from the final analysis of OS data, based on 385 OS events by the end of the third quarter of 2021.
Phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer. All 40 patients have been enrolled in the first part of Module A of the MAHOGANY study, which is evaluating margetuximab in combination with retifanlimab, an anti-PD-1 molecule the Company licensed to Incyte Corporation in 2017. The Company plans to report interim safety and efficacy data on these patients at ESMO (Free ESMO Whitepaper) in September 2021.
Flotetuzumab is a bispecific CD123 × CD3 DART molecule being evaluated in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) acute myeloid leukemia (AML). MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER6 AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in late 2021.
MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. In June 2021, MacroGenics presented updated clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating anti-tumor activity in patients with melanoma and metastatic castration-resistant prostate cancer (mCRPC). Preliminary results in the mCRPC cohort expansion showed 11 of 22 patients (50%) had a PSA reduction of 50% or greater, with anti-tumor activity observed in four of seven patients with measurable disease who had their first 9-week imaging results available, including one unconfirmed partial response. Anti-tumor activity was also reported in all three melanoma patients who received 4 mg/kg in dose escalation, with one patient achieving a confirmed partial response. MGC018 trial cohorts are ongoing for mCRPC, melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN) and triple negative breast cancer (TNBC). MacroGenics will provide an update of clinical data at ESMO (Free ESMO Whitepaper) in September.
Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 mAb. MacroGenics continues to recruit its Phase 2 study of enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative. The Company has recently activated clinical trial sites in Europe to advance enrollment of the study.
Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. MacroGenics is evaluating the molecule in patients as both monotherapy as well as in combination with other agents. The Company’s partner in Greater China, Zai Lab, is evaluating tebotelimab as monotherapy in patients with hepatocellular carcinoma and melanoma as well as in combination with niraparib in a variety of advanced or metastatic solid tumors. MacroGenics expects to provide an update on the next stage of development for tebotelimab later this year.
MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is conducting a Phase 1 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), checkpoint-naïve NSCLC, mCRPC and melanoma.
IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in patients with select cancers and have indicated they anticipate disclosing initial data in early 2022.
MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development. The molecule incorporates a CD3 component designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, along with an Fc domain to permit intermittent dosing through a longer half-life. The Company expects to submit an Investigational New Drug (IND) application to the FDA in the fourth quarter of 2021.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2021 were $297.3 million, compared to $272.5 million as of December 31, 2020. This does not include $55 million in consideration (consisting of a $25 million upfront payment and a $30 million equity investment) received from Zai Lab in July 2021, which related to the execution of the collaboration agreement that was announced on June 16, 2021.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $30.8 million for the quarter ended June 30, 2021, including $3.2 million net sales of MARGENZA, compared to total revenue of $20.3 million for the quarter ended June 30, 2020. This increase was primarily due to the recognition of $14.4 million of revenue from Zai Lab related to the recent June 2021 collaboration announcement and recognition of a $5 million milestone from Incyte Corporation.

R&D Expenses: Research and development expenses were $55.8 million for the quarter ended June 30, 2021, compared to $57.4 million for the quarter ended June 30, 2020.

SG&A Expenses: Selling, general and administrative expenses were $15.2 million for the quarter ended June 30, 2021, compared to $10.2 million for the quarter ended June 30, 2020. This increase was primarily related to MARGENZA launch costs.
Net Loss: Net loss was $39.9 million for the quarter ended June 30, 2021, compared to net loss of $46.9 million for the quarter ended June 30, 2020.

Shares Outstanding: Shares outstanding as of June 30, 2021 were 60,133,447, which excluded 958,467 shares issued to Zai Lab in July as part of the recently announced collaboration.

Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of June 30, 2021, plus consideration received from Zai Lab in July 2021, as well as anticipated and potential collaboration payments, should enable it to fund its operations through 2023, assuming the Company’s programs and collaborations advance as currently contemplated.
Conference Call Information
MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended June 30, 2021 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 7983402.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On July 29, 2021 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the second-quarter 2021 and updated full-year 2021 financial guidance (Press release, West Pharmaceutical Services, JUL 29, 2021, View Source [SID1234585376]).

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Second-Quarter 2021 Summary (comparisons to prior-year period)

Net sales of $723.6 million grew 37.3%; organic sales growth was 30.6%.
Reported-diluted EPS of $2.47 increased 104%.
Adjusted-diluted EPS of $2.46 increased 97%.
Company is raising full-year 2021 net sales guidance to a new range of $2.760 billion to $2.785 billion, compared to a prior range of $2.630 billion to $2.655 billion.
Company is raising full-year 2021 adjusted-diluted EPS guidance to a new range of $8.05 to $8.20, compared to a prior range of $6.95 to $7.10.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"Our strong second quarter performance was driven by continued momentum in organic sales growth in both our base business as well as increased demand for our products associated with COVID-19 vaccines," said Eric M. Green, President and Chief Executive Officer. "Guided by our mission, our dedicated team members remain focused on meeting the increased demand for our high-value product (HVP) components. Our market-led strategy coupled with our scientific leadership and regulatory insights in primary packaging and delivery of injectable drugs have resonated with our customers, resulting in a high participation rate on newly approved molecular entities, especially large molecule therapies. Over the past year and half, we have accelerated capital spending and expanded global HVP manufacturing capacity. Based on growing future demand from our customers, we are announcing another tranche of capital spending to expand HVP capacity that we expect will be ready for production in 2022. Given the strong first half of the year, we are raising our full-year financial guidance."

Proprietary Products Segment

Net sales grew by 47.0% to $587.3 million. Organic sales growth was 39.3%, with currency translation increasing sales growth by 770 basis points. HVP sales represented over 70% of segment sales and generated double-digit organic sales growth, led by customer demand for Westar, NovaPure, FluroTec, Daikyo and Envision components.

The Biologics and Pharma market units had strong double-digit organic sales growth, and the Generics market unit had low-single digit organic sales growth.

Contract-Manufactured Products Segment

Net sales grew by 6.7% to $136.4 million. Organic sales growth was 3.2% with currency translation increasing sales growth by 350 basis points. Segment performance was led by sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first six months of 2021)

Operating cash flow was $233.1 million, an increase of 13.6%. Capital expenditures were $111.6 million, an increase of 61% over the same period last year. Free cash flow (operating cash flow minus capital expenditures) was $121.5 million, a decrease of 10.7%.

During the first-half 2021, the Company repurchased 479,000 shares for $137.1 million at an average share price of $286.23 under its share repurchase program.

Our capital and financial resources, including overall liquidity, remain strong. We believe that cash on hand and cash generated from operations, together with availability under our $300.0 million multi-currency revolving credit facility, will be adequate to address our foreseeable liquidity needs based on our current expectations of our business operations, capital expenditures and scheduled payments of debt obligations.

Full-Year 2021 Financial Guidance

Full-year 2021 net sales are expected to be in a range of $2.760 billion to $2.785 billion, compared to a prior guidance range of $2.630 billion to $2.655 billion.
Organic sales growth is expected to be in a range of 24% to 25%, compared to a prior range of 19% to 20%.
Net sales guidance includes an estimated full-year 2021 benefit of $80 million based on current foreign exchange rates, compared to a prior estimated benefit of $75 million.
Full-year 2021 adjusted-diluted EPS is expected to be in a range of $8.05 to $8.20, compared to a prior range of $6.95 to $7.10.
Full-year adjusted-diluted EPS guidance range includes an estimated benefit of approximately $0.27 based on current foreign currency exchange rates, compared to a prior estimated benefit of $0.23.
The revised guidance includes a $0.24 EPS positive impact from first-half 2021 tax benefits from stock-based compensation.
For the remainder of the year, our EPS guidance range assumes a tax rate of 23% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first-half 2021 would provide a positive adjustment to our full-year EPS guidance.
Second-Quarter 2021 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 3089097.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, August 5, 2021, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 3089097.