On November 7, 2019 DermTech, Inc. (NASDAQ: DMTK) ("DermTech" or the "Company"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported business and financial results as of and for the quarter ended September 30, 2019 and provided a corporate update (Press release, DermTech International, NOV 7, 2019, View Source [SID1234550674]).

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Third Quarter 2019 Business Highlights:

Received Proprietary Laboratory Analyses ("PLA") code (0089U) and favorable crosswalk recommendation to code 0005U by Clinical Diagnostic Laboratory Test Committee ("CDLT")
Signed new agreements for $1.4 million of contract revenue with pharmaceutical partners with the majority of these amounts expected to be recognized as revenue in the fourth quarter
Strengthened the senior leadership team with the hiring of CFO and COO
Continued to expand the commercial team with the hiring of Sr. VP of Payer Access, Director of Managed Care and Payor Contracts and built out the direct sales force
Initiated the TRUST clinical study to further confirm the Pigmented Lesion Assay’s high negative predictive value, through repeat clinical assessment and genomic testing of suspicious lesions after up to two years follow-up
Announced the publication of consensus expert panel recommendations for use for the Pigmented Lesion Assay
Expanded patent portfolio to include PRAME, a key gene in the non-invasive assessment of melanoma using genomics
Presented 1-year Pigmented Lesion Assay real-world registry study data
Third Quarter 2019 Financial Highlights:

Closed Business Combination and PIPE financing to list on The Nasdaq Capital Market, and generated gross cash proceeds of approximately $29 million
Reported assay revenue of $0.4 million, a 20% increase compared to the third quarter of 2018
Reported billable sample volume increase of 18% to 3,596 for the third quarter of 2019 compared to 3,043 for the same period in 2018
Ended the quarter with $21.4 million in cash and cash equivalents
"We spent much of the last quarter building the foundation to scale our commercial operations around our breakthrough Pigmented Lesion Assay for enhanced early melanoma detection. Key areas of success included: completing the business combination and financing, strengthening our senior management team with seasoned executives from the life sciences industry, expanding our payor access team and direct sales force, and establishing our reimbursement code and anticipated price with Medicare. We are off to a strong start as a newly public company and I look forward to a successful year," said John Dobak, M.D., Chief Executive Officer of DermTech.

Third Quarter 2019 Financial Results

Assay revenue increased 20% to $0.4 million for the three months ended September 30, 2019, compared to $0.3 million for the same period of 2018. Total revenues were $0.6 million for each of the three months ended September 30, 2019 and 2018. Contract revenue decreased to $0.2 million for the three months ended September 30, 2019, compared to $0.3 million for the same period of 2018. Contract revenue can be highly variable as it is dependent on the pharmaceutical customers’ clinical trial progress, which can be difficult to forecast due to variability of patient enrollment, drug safety and efficacy and other factors.

Gross margin for the three months ended September 30, 2019 was (38)% compared to (7)% in the same period of 2018. The decrease in gross margin is due to the decrease in contract revenue which produces higher positive gross margins than assay revenue.

Sales and marketing expense increased $1.3 million to $2.0 million for the three months ended September 30, 2019, compared to $0.7 million for the same period of 2018. The increase was primarily attributable to sales force expansion and increased marketing investment.

Research and development expense increased $0.2 million to $0.8 million for the three months ended September 30, 2019, compared to $0.5 million for the same period of 2018. The increase was primarily attributable to higher compensation and recruiting costs related to expanding the research and development team as well as increased laboratory supplies.

General and administrative expense increased $2.4 million to $3.2 million for the three months ended September 30, 2019, compared to $0.8 million for the same period of 2018. The increase was primarily due to additional public company costs, including higher audit and legal costs related to SEC filings in connection with the Business Combination and preparing quarterly financial statements.

Loss from operations was $6.2 million for the three months ended September 30, 2019, which included $0.7 million of non-cash stock-based compensation. We incurred approximately $1.8 million in non-recurring operating costs for the three months ended September 30, 2019, predominantly related to legal fees, Registration Statement filing fees, audit fees and an acceleration of stock-based compensation expense associated with the close of the Business Combination.

Net loss for the three months ended September 30, 2019 was $5.7 million, compared to a net loss of $2.2 million for the same period of 2018.

Cash and cash equivalents totaled $21.4 million as of September 30, 2019.

Closed Business Combination

On August 29, 2019, DermTech completed its business combination with Constellation Alpha Capital Corp. ("Constellation") (the "Business Combination"), a publicly traded special purpose acquisition company prior to the Business Combination. As a result of the Business Combination, the previous DermTech stockholders own a controlling interest in the combined company (the "Company"). Shortly following the completion of the Business Combination, the Company effected a one-for-two reverse stock split of its common stock. DermTech’s Business Combination with Constellation was funded through proceeds received from a private sale of Constellation stock at a split-adjusted price of $6.50 per common share, and cash remaining in Constellation’s trust account after giving effect to stockholder redemptions. As a result of the Business Combination, the Company generated gross proceeds of approximately $29 million, which exceeded the $15 million closing cash requirement previously announced. Participating investors included experienced life sciences investors such as RTW Investments, HLM Venture Partners, Irwin and Gary Jacobs, the founding family of Qualcomm, Inc., and two institutional investors each with over $10 billion in assets under management.

PLA Code Issued

The American Medical Association ("AMA") has issued a PLA Common Procedural Terminology (CPT) code for the DermTech Pigmented Lesion Assay. This PLA code (0089U) was published online with an effective date of July 1, 2019 and is included in the CPT 2020 publication. The CDLT voted nearly unanimously to crosswalk the reimbursement of our code to a currently priced CPT code, 0005U. Final Medicare rate setting for this PLA code is currently in process, with the final fee schedule expected to be published in December 2019. We currently have a draft Local Coverage Determination ("LCD") from MolDX and anticipate that we will have the final LCD policy by year-end. These activities will enable us to establish our coding, coverage, and reimbursement for the Pigmented Lesion Assay with Medicare for dates of service in early 2020 following the receipt of the final LCD.

New Contract Revenue Agreements

During the three months ended September 30, 2019, DermTech entered into $1.4 million of new agreements with two large pharmaceutical companies to support their clinical trials. We expect the majority of these amounts will be recognized as revenue prior to year-end.

New Leadership Hires

In September, the Company announced that Kevin Sun was appointed Chief Financial Officer, Treasurer and Secretary. Mr. Sun brings nearly two decades of corporate finance experience, including debt and equity financings, acquisitions, commercial product launches and infrastructure scaling and expansion projects mostly in the medical device and diagnostic industries. From 2008 to 2018, Mr. Sun served in various executive and management roles for DexCom, Inc., a NASDAQ-listed medical device company, including most recently as Vice President, Corporate Controller and Treasury, Interim Chief Financial Officer, and Vice President, Finance. Prior to DexCom, Mr. Sun held various roles of increasing responsibility at Biosite Incorporated, a NASDAQ-listed leader in rapid point of care diagnostics. Mr. Sun holds a B.S. in Business with a dual major in Accounting and Finance, a minor in Psychology, a Masters in Strategic Management and an MBA from the Kelley School of Business at Indiana University.

In November, Claudia Ibarra started employment as the Company’s Chief Operating Officer. Ms. Ibarra has over 25 years of experience in clinical laboratory operations, in the areas of oncology, immunology and molecular biology. In her leadership roles, she grew and developed the laboratory operations of renowned diagnostic companies to a highly efficient and successful state, with high quality, service level and inspection track records. Before joining DermTech, Ms. Ibarra served as Senior Vice President, Laboratory Operations at Exagen, Director of the molecular oncology laboratory at Genoptix, Inc., where she was also the Molecular Genetic Training Program Coordinator, and other reference clinical laboratories focused on immunology and solid tumors. Ms. Ibarra holds a degree in Biochemistry with specialization in clinical laboratory science from the University of Buenos Aires, Argentina and a California License as Clinical Laboratory Scientist.

Commercial Team Expansion

In November, Dan Visage started employment as the Company’s Senior Vice President of Payor Access. Mr. Visage has over 20 years of health care leadership experience, principally in developing high-performing teams to contract and manage health plan relationships. These include, large national payors, Blues plans, and other large local payors. He has held many diverse leadership roles that give him a unique understanding of the Sales, Marketing, Sales Management, Operations, and Finance functions of a healthcare organization. He most recently was the Vice-President of Managed Care at Progenity and prior to that has held leadership positions at Bio Reference Laboratories / OPKO Health and LabCorp. In each role he has expanded covered lives and obtained coverage for several diagnostic technologies. These include, whole exome sequencing, non-invasive prenatal testing, targeted oncology genomic sequencing, expanded carrier screening genetic testing and a prostate cancer algorithmic test. He also has extensive experience working at various health plans and has held management roles at Florida Blue, Kaiser Permanente and CareCentrix. He has an Accounting degree from Cal State Sacramento, an MBA from the University of Tampa, and is a CPA (inactive).

In September, Chris Murphy started employment as the Company’s Director of Managed Care and Payor Contracting. Mr. Murphy has over 15 years of leadership experience across the legal, consulting, and healthcare industries. Within healthcare, Mr. Murphy has worked with niche-product/service providers in the areas of durable medical equipment, cardiac diagnostics, post-acute care, and home dialysis. In these roles, he has deployed effective contracting and business strategies and collaborated with large national payors, Blues plans, and other large local payors, in which he expanded market access and established mutually beneficial processes with the payor partner. Mr. Murphy also has extensive operational experience in the areas of reimbursement, compliance and sales management. Before joining DermTech, Mr. Murphy served as the Director of Revenue Cycle at Fresenius Medical Care, Director of Revenue Management at NxStage Kidney Care, and Manager, Contracts at ZOLL Services. Mr. Murphy holds a B.A. in History from the University of Wisconsin, and a J.D. from the UIC John Marshall Law School in Chicago, Illinois.

During the third quarter we continued to increase our direct sales force from 7 sales reps at the beginning of the year to 23 sales reps as of the beginning of the fourth quarter. All sales reps have significant experience direct selling and launching new products in dermatology. In preparation for our anticipated LCD from Medicare, territory locations for hiring were determined by assessing Medicare procedure volumes for melanoma surgical biopsies.

Initiated TRUST Clinical Study

The TRUST study is the first of its kind for the Company to provide repeat clinical assessments and genomic testing on pigmented lesions suspicious for melanoma that were initially tested negative with the Pigmented Lesion Assay. This study will further confirm the high negative predictive value of the Pigmented Lesion Assay (>99%), by examining the long-term clinical behavior of pigmented lesions initially determined to be negative for melanoma after testing with the Pigmented Lesion Assay. The study will perform the repeat assessment and testing 1 to 2 years following the initial test. We expect the results to be available in 2020.

Inclusion in Clinical Management Recommendations

In October, the Company announced its inclusion in Clinical Management Recommendations, "Appropriate Use Criteria for the Integration of Diagnostic and Prognostic Gene Expression Profile Assays into the Management of Cutaneous Malignant Melanoma: An Expert Panel Consensus-Based Modified Process Assessment" published in the September issue of SKIN. A panel of dermatologists and dermatopathologists with expertise in pigmented lesions, melanoma, and gene expression technology evaluated commercially available gene expression tests and recommended use of DermTech’s non-invasive Pigmented Lesion Assay, or 2-Gene Expression Profile test, in cases in which patients present with atypical lesions requiring additional assessment beyond visual inspection in order to inform the decision to surgically biopsy. This recommendation closely aligns with the previously published utility data on the Pigmented Lesion Assay (Ferris et al., Melanoma Research, 2018), which found that clinicians appropriately biopsied all Pigmented Lesion Assay positive lesions while managing 99% of Pigmented Lesion Assay negative lesions with surveillance and without surgical biopsies.

Expanded Patent Portfolio

In October, the Company announced the issuance of a patent, US 10,407,729, to further expand the Company’s intellectual property and leadership position. This patent is entitled "Diagnosis of melanoma by nucleic acid analysis" and includes claims in connection with DermTech’s technology to non-invasively obtain genomic information for characterizing skin lesions. The patent includes claims related to using expression levels of PRAME (also known as preferentially expressed antigen in melanoma, which is overexpressed in this type of cancer) to differentiate melanoma from non-melanoma skin samples obtained via the company’s adhesive patch-based sample collection platform. DermTech has discovered that PRAME is a key gene in the non-invasive assessment of melanoma using genomics.

Presentation of 1-Year Pigmented Lesion Assay Registry Study Data

In August, the Company presented 1-year Pigmented Lesion Assay registry data on 3,418 real-world cases from 53 US-based sites at the ‘Practical Symposium,’ an annual well recognized dermatology conference held in Beaver Creek, CO. The Pigmented Lesion Assay reduced avoidable biopsies by over 90%. Pigmented Lesion Assay positive cases were surgically biopsied 98% of the time and Pigmented Lesion Assay negative cases were clinically monitored and not surgically biopsied in over 99%. Clinicians follow the guidance of the Pigmented Lesion Assay.

On November 7, 2019 GenomOncology, LLC (GO) reported that it was selected by the Duke Cancer Institute to utilize GO’s Precision Oncology Platform to provide real-time therapeutic, prognostic, and clinical trial recommendations to molecular tumor board organizers and participants at Duke Cancer Institute (Press release, GenomOncology, NOV 7, 2019, View Source [SID1234550691]). Duke will leverage GenomOncology’s GO Connect product to automatically load patient, molecular, and institutional trial data into GO’s Knowledge Management System (KMS) for use by Duke in GO’s Molecular Tumor Board Application. This will include incorporating information from Duke’s clinical data warehouse, multiple Next Gen Sequencing vendors, and OnCore.

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The GO KMS enables precision health approaches by allowing physicians and researchers to aggregate and analyze biomarker-based data within a ‘genomics-aware’ framework that includes a diverse set of annotations including genes, pathways, drugs, alterations, transcripts, and diseases. GO’s KMS clinical trial database contains over 4,100 clinical trials curated by the My Cancer Genome team for comprehensive clinical reporting.

On November 7, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported its financial results for the third quarter ended September 30, 2019, and provided an update on the Company’s recent activities (Press release, Ziopharm, NOV 7, 2019, View Source [SID1234550707]).

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"Our company took dramatic steps forward in the past quarter, in particular with our TCR-T platform," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "The NCI advanced the TCR program using our Sleeping Beauty platform into a phase 2 trial and our new agreement with MD Anderson accelerates expansion of our TCR library and sets the foundation for two new clinical trials to be conducted there by Ziopharm. Our confidence surges as we have partnered with these leading institutions in tackling the massive, untapped market in solid tumors."

Program Updates

Sleeping Beauty TCR-T

The Company is using its non-viral gene transfer technology to implement personalized T-cell therapy targeting solid tumors with neoantigen-specific TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is undertaking a phase 2 clinical trial to treat patients with metastatic/advanced solid tumors using the Company’s Sleeping Beauty transposon/transposase platform to genetically modify patient-derived T cells with TCRs to target patient-specific neoantigens.

Phase 2 Sleeping Beauty TCR-T cell therapy trial at NCI: In recent weeks, the NCI has provided details of the initiated clinical trial in solid tumors to evaluate TCR T-cell therapy utilizing Ziopharm’s Sleeping Beauty platform: A Phase 2 Study Using the Administration of Autologous T-Cells Engineered Using the Sleeping Beauty Transposon/Transposase System to Express T-Cell Receptors Reactive Against Mutated Neoantigens in Patients With Metastatic Cancer (NCT0402436). Under the direction of Steven Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI, and his team, the trial will enroll patients with a range of solid cancers.

New agreement with MD Anderson Cancer Center accelerates TCR hotspot library expansion and enables future Ziopharm clinical trials: Ziopharm announced last week a new research and development agreement with MD Anderson for the Sleeping Beauty immunotherapy program to use non-viral gene transfer to stably express and clinically evaluate neoantigen-specific TCRs in T cells. This agreement will accelerate expansion of the library of TCRs against neoantigens in hotspots including mutated KRAS, TP53 and EGFR licensed from NCI earlier this year. Additionally, this agreement provides the foundation for two new Ziopharm TCR-T clinical trials to be conducted at MD Anderson: a trial for utilizing TCRs from the library targeting hotspot mutations, and a second trial for personalized TCRs targeting patient-specific neoantigens.

Sleeping Beauty CAR-T

Ziopharm is advancing the Sleeping Beauty platform for the rapid personalized manufacture (RPM) of CD19-specific CAR-T, co-expressing membrane bound IL-15 (mbIL15) with a safety switch. Per the IND, RPM produces T cells with viability of at least 70% that can be infused the day after gene transfer. This work on our third-generation Sleeping Beauty technology is undertaken in collaboration with MD Anderson Cancer Center in the United States and in Greater China through a joint venture, Eden BioCell.

FDA Cleared IND for phase 1 trial for RPM of CD19-specific CAR-T: In October, the Company announced that FDA cleared an IND for a phase 1 clinical trial to assess CD19-specific CAR-T, produced using RPM. The study will be conducted at MD Anderson as an investigator-initiated trial. Patients with CD19+ leukemias and lymphomas who have relapsed after allogeneic bone marrow transplantation will be enrolled to evaluate infusion of donor-derived RPM CAR-T.

Abstract accepted at 2019 ASH (Free ASH Whitepaper) Annual Meeting: Investigators will present preclinical data on the benefit of mbIL15 on the rapid personalized manufacture (RPM) of TCR-T at the 2019 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December.

Controlled IL-12

Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit and sustain cancer-fighting T cells within solid tumors. Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex for the treatment of recurrent glioblastoma multiforme (rGBM) as monotherapy and in combination with immune checkpoint inhibitors. In August, supportive data from the phase 1 monotherapy trial were published in Science Translational Medicine.

Enrollment completed in third cohort of combination study with OPDIVO (nivolumab): Ziopharm announced in June that it had completed enrollment in three dosing cohorts in its phase 1 study of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex in combination with OPDIVO, an immune checkpoint inhibitor against programmed death-1 (PD-1). Investigators from this multi-center trial indicated interest in expanding the study and have enrolled all 12 additional patients at the highest dosing level.

Phase 2 combination trial with Regeneron’s Libtayo (cemiplimab-rwlc) initiated in June: The Company, in collaboration with Regeneron Pharmaceuticals, initiated a phase 2 trial at the end of the second quarter to evaluate Ad-RTS-hIL-12 plus veledimex in combination with

Regeneron’s PD-1 antibody Libtayo to treat patients with rGBM. As prescribed in the study protocol, the first six patients have been dosed, and are completing the required monitoring period prior to the resumption of enrollment. The Company expects to enroll about 30 patients at approximately 10 sites.

Abstracts accepted at 2019 SNO Annual Meeting: Investigators will present data from two ongoing trials in the Controlled IL-12 platform, both as monotherapy and in combination with OPDIVO, in two posters at the 2019 Annual Meeting of the Society for Neuro-Oncology (SNO) in November.

EMA grants Orphan Drug status to Controlled IL-12 program: Ziopharm announced in August that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending Controlled IL-12 for designation as an orphan medicinal product for the treatment of glioma, which has subsequently been adopted by the European Commission.

Corporate Updates

Balance sheet strengthened: Early in the third quarter, a group of Ziopharm shareholders, led by MSD Partners, L.P., exercised their existing warrants to purchase common stock, which resulted in gross proceeds of approximately $52 million. With more than $88 million in cash at the end of the third quarter, Ziopharm has sufficient capital to fund operations into the first half of 2021 and provide visibility into important clinical data milestones for the Company’s TCR-T, CAR-T and Controlled IL-12 programs.

Expanded Ziopharm Laboratory and Office on MD Anderson Campus: Concurrent with the new R&D agreement with MD Anderson announced last week, through a new lease Ziopharm is also significantly expanding its R&D footprint on the MD Anderson campus.

Dr. Chris Bowden joins Board of Directors: In October, Ziopharm appointed Chris Bowden, M.D., an oncology drug development executive with more than 20 years leadership experience spanning pre-clinical development through commercialization, including the approval of several cancer medicines, to the Company’s Board. The addition of Dr. Bowden represents the sixth new board member for Ziopharm in the past 18 months.

Third Quarter 2019 Financial Results

The Company recorded a one-time, non-cash charge during the quarter of $60.8 million associated with the warrant exercise transaction.

Reflecting the $60.8 million, ($0.36) per share, non-cash charge, the net loss applicable to the common shareholders for the third quarter of 2019 was $74.0 million, or $(0.43) per share, compared to a net loss of $18.7 million, or $(0.13) per share, for the third quarter of 2018.

Research and development expenses were $8.6 million for the third quarter of 2019, compared to $8.3 million for the third quarter of 2018.

General and administrative expenses were $4.8 million for the third quarter of 2019, compared to $4.3 million for the third quarter of 2018.

The Company ended the quarter with unrestricted cash resources of approximately $88 million.

In addition, a prepayment of approximately $21.5 million remains for programs to be conducted by the Company at MD Anderson under the current Research and Development Agreement.

Conference Call and Webcast

Scheduled for today at 4:30 pm ET, the conference call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 8279471. To access the live webcast or the subsequent archived recording, visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.-

On November 7, 2019 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported that the requisite number of consents have been received to adopt certain proposed amendments (the "Amendments") with respect to all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc. ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (Press release, AbbVie, NOV 7, 2019, View Source [SID1234550723]). The results are based on (i) early tenders in the offers to exchange (each an Exchange Offer" and, collectively, the "Exchange Offers") any and all Allergan Notes (as defined below) for new notes to be issued by AbbVie (the "AbbVie Notes") and (ii) early delivery of consents in the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt the Amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes.

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The applicable Allergan obligors have executed a supplemental indenture with respect to each Allergan Indenture implementing the Amendments. The Amendments will become operative only upon settlement of the Exchange Offers. The settlement date is expected to occur promptly after the Expiration Date (as defined below), which is expected to be on or about the closing date of AbbVie’s previously announced proposed acquisition of Allergan (the "Acquisition").

As of 5:00 p.m., New York City time, on November 7, 2019 (the "Early Participation Date"), the principal amounts of Allergan Notes set forth in the table below were validly tendered and not validly withdrawn (and consents thereby validly given and not validly revoked). For each $1,000 principal amount of Allergan USD Notes (as defined below) or €1,000 principal amount of Allergan Euro Notes (as defined below) validly tendered and not validly withdrawn at or prior to the Early Participation Date, eligible holders will be eligible to receive an early participation payment of $1.00 or €1.00, as applicable, in cash (the "Early Participation Payment"). The Early Participation Payment will be paid on the settlement date for the Exchange Offers to the noteholder of record on the Early Participation Date, even if such noteholder is no longer the noteholder of record of such Allergan Notes on the settlement date. In addition, for each $1,000 principal amount of Allergan USD Notes or €1,000 principal amount of Allergan Euro Notes validly tendered and not validly withdrawn prior to the Expiration Date, eligible holders will be eligible to receive $1,000 principal amount of the AbbVie USD Notes of the applicable series or €1,000 principal amount of the AbbVie Euro Notes of the applicable series, as applicable (the "Exchange Consideration"). The total consideration consists of (a) the Exchange Consideration plus (b) the Early Participation Payment (collectively, the "Total Consideration").

After the Early Participation Date, tendered Allergan Notes may be withdrawn. However, to be eligible to receive the Exchange Consideration component of the Total Consideration, such withdrawn Allergan Notes must be validly re-tendered and not validly withdrawn at or prior to the Expiration Date. A valid withdrawal of the tendered Allergan Notes will not be deemed a revocation of the related consents and such consents will continue to be deemed delivered.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

Each Exchange Offer will expire at 11:59 p.m., New York City time, on November 22, 2019 (as the same may be extended, the "Expiration Date"), unless terminated. Each Consent Solicitation expired at the Early Participation Date. The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and the Expiration Date of each of the Exchange Offers is expected to be extended to occur on or about the closing date of the Acquisition, which is expected to occur in early 2020. As a result, the Expiration Date may be extended one or more times. AbbVie currently anticipates providing notice of any such extension in advance of the Expiration Date.

In this news release, references to the "Allergan Euro Notes" collectively refer to (i) the Floating Rate Notes due 2020 issued by Allergan Funding, (ii) the 0.500% Senior Notes due 2021 issued by Allergan Funding, (iii) the 1.500% Senior Notes due 2023 issued by Allergan Funding, (iv) the 1.250% Senior Notes due 2024 issued by Allergan Funding, (v) the 2.625% Senior Notes due 2028 issued by Allergan Funding and (vi) the 2.125% Senior Notes due 2029 issued by Allergan Funding. References to the "Allergan USD Notes" collectively refer to (i) the 3.375% Senior Notes due 2020 issued by Allergan Inc, (ii) the 4.875% Senior Notes due 2021 issued by Allergan Sales, (iii) the 5.000% Senior Notes due 2021 issued by Allergan Sales, (iv) the 3.450% Senior Notes due 2022 issued by Allergan Funding, (v) the 3.250% Senior Notes due 2022 issued by Allergan Finance, (vi) the 2.800% Senior Notes due 2023 issued by Allergan Inc, (vii) the 3.850% Senior Notes due 2024 issued by Allergan Funding, (viii) the 3.800% Senior Notes due 2025 issued by Allergan Funding, (ix) the 4.550% Senior Notes due 2035 issued by Allergan Funding, (x) the 4.625% Senior Notes due 2042 issued by Allergan Finance, (xi) the 4.850% Senior Notes due 2044 issued by Allergan Funding and (xii) the 4.750% senior notes due 2045 issued by Allergan Funding. The Allergan USD Notes and the Allergan Euro Notes are referred to herein collectively as the "Allergan Notes."

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Allergan Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" as defined in Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or not a "U.S. person" and outside the United States within the meaning of Regulation S under the Securities Act. The complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the Offering Documents, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-3900 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source Holders of Allergan Notes that are not eligible holders will not be able to receive such documents, but AbbVie will make alternative arrangements available, subject to applicable law. Such holders should contact Global Bondholder Services Corporation to receive information about arrangements available to them.

This news release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the Offering Documents and only to such persons and in such jurisdictions as are permitted under applicable law.

The AbbVie Notes offered in the Exchange Offers have not been registered under the Securities Act or any state securities laws. Therefore, the AbbVie Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and any applicable state securities laws.

On November 7, 2019 Mettler-Toledo International Inc. (NYSE: MTD) reported third quarter results for 2019 (Press release, Mettler-Toledo, NOV 7, 2019, View Source [SID1234550842]). Provided below are the highlights:

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Reported sales increased 3% compared with the prior year. In local currency, sales increased 4% in the quarter as currency reduced sales growth by 1%.
Net earnings per diluted share as reported (EPS) were $5.20, compared with $4.93 in the prior-year period. Adjusted EPS was $5.77, an increase of 13% over the prior-year amount of $5.12. Adjusted EPS is a non-GAAP measure, and we have included a reconciliation to EPS on the last page of the attached schedules.
Quarterly Results

Olivier Filliol, President and Chief Executive Officer, stated, "Local currency sales growth in the quarter excluding Food Retail, was 6%, with excellent growth in the Americas and solid growth in Europe and Asia/Rest of World. Despite continued challenges from the impact of adverse currency and tariff costs, we achieved strong margin improvement and earnings growth in the quarter."

GAAP Results
EPS in the quarter was $5.20, compared with the prior-year amount of $4.93.

Compared with the prior year, total reported sales increased 3% to $753.9 million. By region, reported sales increased 6% in the Americas and 2% in Asia/Rest of World. Reported sales in Europe declined by 2%. Earnings before taxes amounted to $169.4 million, compared with $160.4 million in the prior year.

Non-GAAP Results
Adjusted EPS was $5.77, an increase of 13% over the prior-year amount of $5.12.

Compared with the prior year, total sales in local currency increased 4% as currency reduced reported sales growth by 1%. By region, local currency sales increased 7% in the Americas, 2% in Europe and 4% in Asia/Rest of World. Adjusted Operating Profit amounted to $196.2 million, an 8% increase from the prior-year amount of $182.0 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Year-to-Date Results

GAAP Results
EPS was $14.67, compared with the prior-year amount of $12.81.

Compared with the prior year, total reported sales increased 2% to $2.165 billion. By region, reported sales increased 5% in the Americas and 3% in Asia/Rest of World. Reported sales in Europe declined 2%. Earnings before taxes amounted to $450.3 million, compared with $421.4 million in the prior year.

Non-GAAP Results
Adjusted EPS was $15.02, an increase of 11% over the prior-year amount of $13.50.

Compared with the prior year, total sales in local currency increased 5% as currency reduced reported sales growth by 1%. By region, local currency sales increased 5% in the Americas, 3% in Europe and 7% in Asia/Rest of World. Adjusted Operating Profit amounted to $521.8 million, a 6% increase from the prior-year amount of $490.8 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Outlook

Based on today’s assessment of market conditions, management anticipates that local currency sales growth in the fourth quarter 2019 will be approximately 3%, and Adjusted EPS is forecasted to be in the range of $7.66 to $7.71, an increase of 12% to 13%.

For the full year 2019, local currency sales growth is expected to be approximately 5%. This sales growth is expected to result in Adjusted EPS in the range of $22.65 to $22.70, an increase of 11% to 12%.

The Company said that based on its assessment of market conditions today, management anticipates local currency sales growth in 2020 will be approximately 4%. This sales growth is expected to result in Adjusted EPS in the range of $24.85 to $25.10. Using the mid-point of 2019 guidance, this would result in Adjusted EPS growth of 10% to 11%.

While the Company has provided an outlook for local currency sales growth and Adjusted EPS, it has not provided an outlook for reported sales growth or EPS as it would require an estimate of currency exchange fluctuations and non-recurring items, which are not yet known. The Company noted in making its outlook that uncertainty remains in the macroeconomic environment and market conditions are subject to change.

Conclusion

Filliol concluded, "We continue to benefit from our growth initiatives including investments in our field force, Spinnaker sales and marketing programs and new product launches. With the exception of Food Retail, demand in our markets is solid and we have generated good growth. As we look to 2020, we remain confident in the factors we can control – namely executing on our growth initiatives to continue to gain market share – but acknowledge greater uncertainty in the macroeconomic environment. We also believe that our margin and productivity initiatives will continue to yield tangible results. Based on market conditions today, we believe we can deliver strong results in 2019 and 2020."

Other Matters

The Company will host a conference call to discuss its quarterly results today (Thursday, November 7) at 5:00 p.m. Eastern Time. To hear a live webcast or replay of the call, visit the investor relations page on the Company’s website at www.mt.com/investors. The presentation referenced in the conference call will be located on the website prior to the call.