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United States Securities and Exchange Commission Form
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) February 5, 2020 Merck & Co., Inc. (Exact name of registrant as specified in its charter) New Jersey 1-6571 22-1918501 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 2000 Galloping Hill Road, Kenilworth, NJ 07033 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code (908) 740-4000 Not Applicable (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. -
Merck & Co., Inc
As filed with the Securities and Exchange Commission on February 25, 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2020 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth New Jersey 07033 (908) 740-4000 New Jersey 22-1918501 (State or other jurisdiction of incorporation) (I.R.S Employer Identification No.) Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2021: 2,530,315,668. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2020 based on closing price on June 30, 2020: $195,461,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. -
Merck & Co., Inc
As filed with the Securities and Exchange Commission on February 26, 2020 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2019 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth New Jersey 07033 (908) 740-4000 New Jersey 22-1918501 (State or other jurisdiction of incorporation) (I.R.S Employer Identification No.) Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2020: 2,536,268,760. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2019 based on closing price on June 30, 2019: $215,106,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. -
2018 Medicines in Development for Skin Diseases
2018 Medicines in Development for Skin Diseases Acne Drug Name Sponsor Indication Development Phase ADPS topical Taro Pharmaceuticals USA acne vulgaris Phase II completed Hawthorne, NY www.taro.com AOB101 AOBiome acne vulgaris Phase II (topical ammonia oxidizing bacteria) Cambridge, MA www.aobiome.com ASC-J9 AndroScience acne vulgaris Phase II (androgen receptor degradation Solana Beach, CA www.androscience.com enhancer) BLI1100 Braintree Laboratories acne vulgaris Phase II completed Braintree, MA www.braintreelabs.com BPX-01 BioPharmX acne vulgaris Phase II (minocycline topical) Menlo Park, CA www.biopharmx.com BTX1503 Botanix Pharmaceuticals moderate to severe acne vulgaris Phase II (cannabidiol) Plymouth Meeting, PA www.botanixpharma.com CJM112 Novartis Pharmaceuticals acne vulgaris Phase II (IL-17A protein inhibitor) East Hanover, NJ www.novartis.com clascoterone Cassiopea acne vulgaris Phase III (androgen receptor antagonist) Lainate, Italy www.cassiopea.com Medicines in Development: Skin Diseases ǀ 2018 Update 1 Acne Drug Name Sponsor Indication Development Phase CLS001 Cutanea acne vulgaris Phase II (omiganan) Wayne, PA www.cutanea.com DFD-03 Promius Pharma acne vulgaris Phase III (tazarotene topical) Princeton, NJ www.promiuspharma.com DMT310 Dermata Therapeutics moderate to severe acne vulgaris Phase II (freshwater sponge-derived) San Diego, CA www.dermatarx.com finasteride Elorac severe nodulocystic acne Phase II (cholestenone 5-alpha Vernon Hills, IL www.eloracpharma.com reductase inhibitor) FMX101 Foamix moderate to severe -
Merck & Co., Inc
As filed with the Securities and Exchange Commission on February 27, 2018 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2017 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth, N. J. 07033 (908) 740-4000 Incorporated in New Jersey I.R.S. Employer Identification No. 22-1918501 Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Name of Each Exchange on which Registered Common Stock ($0.50 par value) New York Stock Exchange 1.125% Notes due 2021 New York Stock Exchange 0.500% Notes due 2024 New York Stock Exchange 1.875% Notes due 2026 New York Stock Exchange 2.500% Notes due 2034 New York Stock Exchange 1.375% Notes due 2036 New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2018 : 2,696,190,502. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2017 based on closing price on June 30, 2017: $174,700,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. -
Viralytics Presents New CAVATAK® Data at the 11Th International Oncolytic Virus Conference
ASX and Media Release Viralytics Presents New CAVATAK® Data at the 11th International Oncolytic Virus Conference 11 April 2018, Sydney, Australia: Viralytics Limited (ASX: VLA, OTCQX: VRACY) today reported updated positive clinical trial results for CAVATAK®, an oncolytic virus and the company’s lead investigational product, at the 11th International Oncolytic Virus Conference (OVC) in Oxford, UK. The new data represent progress in the ongoing CAPRA, MITCI and KEYNOTE-200 clinical studies assessing CAVATAK in combination with leading cancer immunotherapy agents. The oral presentation was given by Professor Hardev Pandha MB ChB FRCP FRACP PhD FRSB from the Royal Surrey County Hospital (UK), who is currently participating in the KEYNOTE-200 study. Regarding the trial data, outlined in more detail below, Professor Pandha said “The data from all the CAVATAK/checkpoint combination studies, although in a relatively small number of patients, is impressive. The low incidence and low grade of adverse events are encouraging. For KEYNOTE-200, in particular, there are encouraging signals for this study, however, the data needs to mature and I look forward to seeing the updated information as it becomes available.” CAVATAK Clinical Trial Update In the OVC presentation entitled Clinical evaluation of a novel oncolytic immunotherapy agent, CAVATAK® in combination with immune checkpoint therapy in advanced cancer patients, Professor Pandha highlighted CAVATAK as a very promising oncolytic virus which is backed by a growing body of clinical evidence. Professor Pandha gave an overview of updated results from the Phase 1b CAPRA1 clinical trial, in late-stage melanoma patients being treated with a combination of intralesional CAVATAK and KEYTRUDA®2 (pembrolizumab). -
Merck & Co., Inc
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File No. 1-6571 Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth, N.J. 07033 (908) 740-4000 Incorporated in New Jersey I.R.S. Employer Identification No. 22-1918501 The number of shares of common stock outstanding as of the close of business on July 31, 2018: 2,659,525,311 Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. -
News Release
News Release ____________________________________________________________________________ FOR IMMEDIATE RELEASE Media Contact: Claire Gillespie Investor Contacts: Teri Loxam (267) 305-0932 (908) 740-1986 Michael DeCarbo (908) 740-1807 Merck Announces Third-Quarter 2018 Financial Results Third-Quarter 2018 Worldwide Sales Were $10.8 Billion Third-Quarter 2018 GAAP EPS was $0.73, Third-Quarter Non-GAAP EPS was $1.19 Company Narrows 2018 Full-Year Revenue Range to be Between $42.1 Billion and $42.7 Billion, Including a Minimal Impact from Foreign Exchange Company Narrows and Lowers 2018 Full-Year GAAP EPS Range to be Between $2.41 and $2.47; Narrows and Raises 2018 Full-Year Non-GAAP EPS Range to be Between $4.30 and $4.36, Including an Approximately 1 Percent Negative Impact from Foreign Exchange Results from KEYNOTE-426 Studying KEYTRUDA in Combination with Axitinib as First- line Treatment for Advanced or Metastatic Renal Cell Carcinoma Met Primary Endpoints of Overall Survival and Progression-Free Survival Company Announces 15 Percent Increase to Quarterly Dividend to 55 Cents Per Outstanding Share and Authorizes an Additional $10 Billion Share Repurchase, Including a $5 Billion Accelerated Share Repurchase Program KENILWORTH, N.J., Oct. 25, 2018 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2018. “We built on our strong momentum during the quarter and believe that Merck is well- positioned to continue creating sustainable value for shareholders and patients,” said Kenneth C. Frazier, Merck Chairman and CEO. “Our focused execution is driving our operational results, with KEYTRUDA making a difference to cancer patients around the world. -
Merck & Co., Inc
As filed with the Securities and Exchange Commission on February 27, 2019 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2018 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth, N. J. 07033 (908) 740-4000 Incorporated in New Jersey I.R.S. Employer Identification No. 22-1918501 Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Name of Each Exchange on which Registered Common Stock ($0.50 par value) New York Stock Exchange 1.125% Notes due 2021 New York Stock Exchange 0.500% Notes due 2024 New York Stock Exchange 1.875% Notes due 2026 New York Stock Exchange 2.500% Notes due 2034 New York Stock Exchange 1.375% Notes due 2036 New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2019: 2,581,220,308. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2018 based on closing price on June 30, 2018: $161,991,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. -
Viral Targeting of Non-Muscle Invasive Bladder Cancer and Priming of Anti-Tumour Immunity Following Intravesical Coxsackievirus A21
Author Manuscript Published OnlineFirst on July 4, 2019; DOI: 10.1158/1078-0432.CCR-18-4022 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Title: Viral targeting of non-muscle invasive bladder cancer and priming of anti-tumour immunity following intravesical Coxsackievirus A21 Running Title: Viral targeting of non-muscle invasive bladder cancer. Authors: Nicola E. Annels1+, David Mansfield2+, Mehreen Arif1, Carmen Ballesteros-Merino3, Guy R. Simpson1, Mick Denyer1, Sarbjinder S. Sandhu4, Alan A. Melcher2, Kevin J. Harrington2, Bronwyn Davies5, Gough Au5, Mark Grose5, Izhar Bagwan1, Bernard Fox3, Richard Vile6, Hugh Mostafid1, Darren Shafren5, Hardev S. Pandha1*. Affiliations: 1Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK 2Targeted Therapy Group, Institute of Cancer Research, London, UK 3Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute, Portland, Oregon, USA. 4Kingston Hospital NHS Foundation Trust, Galsworthy Road, Kingston upon Thames, Surrey KT2 7QB 5Viralytics, Sydney, Australia. 6Mayo Clinic, 200 First St. SW Rochester, MN 55905 + Joint first authors *To whom correspondence should be addressed to: Hardev Pandha - Targeted Cancer Therapy, Leggett Building, Daphne Jackson Road, University of Surrey, Guildford, Surrey, UK, GU2 7WG. [email protected] 1 Downloaded from clincancerres.aacrjournals.org on September 30, 2021. © 2019 American Association for Cancer Research. Author Manuscript Published OnlineFirst on July 4, 2019; DOI: 10.1158/1078-0432.CCR-18-4022 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Keywords: Non-muscle, bladder, cancer, oncolytic, virus, Funding: Viralytics Ltd funded this study, Conflict of interest: HP previously received research funding from Viralytics. -
Merck & Co., Inc
As filed with the Securities and Exchange Commission on February 26, 2020 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2019 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth New Jersey 07033 (908) 740-4000 New Jersey 22-1918501 (State or other jurisdiction of incorporation) (I.R.S Employer Identification No.) Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2020: 2,536,268,760. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2019 based on closing price on June 30, 2019: $215,106,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. -
Immutep (IMM) 22 April 2020 Speculative Investment
Dr DENNIS HULME [email protected] +612 9377 1500 www.taylorcollison.com.au Immutep (IMM) 22 April 2020 Speculative Investment Leading not LAGging Recommendation: Outperform Summary (AUD) Our View Market Capitalisation $59M Immutep is developing therapies based on LAG-3 through in-house programs Share price $0.15 and licensing deals with big pharma. Its share price fell last month when the 52 week low $0.11 progression free survival benefit from adding its antigen presenting cell activator 52 week high $0.49 ‘efti’ to chemo in the AIPAC Phase IIb breast cancer study failed to reach Cash as at 31 March 2020 $16.1m statistical significance. However, the higher tumour response rate in AIPAC (48% vs 38%) indicates that efti activates the immune system. We view this as a strong positive indicator for the continued success of ongoing studies of efti plus Share price graph (AUD) the immune checkpoint inhibitors (ICI) Keytruda and Bavencio – response rates 0.500.60 IMM CGSASX Small Ords for melanoma, lung and head and neck cancers have been at least 50% higher 0.45 than the rates reported for Keytruda alone. ICI combos are where the real value 0.50 0.40 in efti lies, in our view. IMM’s value is further supported by Phase II LAG-3 0.35 programs out-licensed to Novartis and GSK. We initiate coverage with a risk 0.40 0.30 adjusted DCF valuation of A$327m or $0.53/sh fully diluted ($0.83/sh undiluted). 0.250.30 Key Points 0.20 0.20 0.15 Efti plus chemo not sufficiently active in metastatic breast cancer – 0.10 Immutep’s lead in-house product, efti, delivered only modest, non-significant 0.10 0.05 improvements in tumour response rates and progression free survival when to 0.00 chemotherapy in breast cancer patients in AIPAC.