On February 6, 2020 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported that company management will participate in two upcoming conferences (Press release, Xencor, FEB 6, 2020, View Source [SID1234553958]):

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Guggenheim Healthcare Talks Forum | Oncology Day
Date: Thursday, February 13, 2020
Location: New York
Presentation Time: 9:00 a.m. EST
9th Annual SVB Leerink Global Healthcare Conference
Date: Wednesday, February 26, 2020
Location: New York
Presentation Time: 11:00 a.m. EST
Live webcasts of these presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. A replay of the events will be posted on the Xencor website approximately one hour after the live events and will be available for 30 days following the presentations.

On February 6, 2020 BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, reported quarterly revenues of $4.225 billion for the first fiscal quarter ended December 31, 2019 (Press release, BD Pharmaceutical Systems, FEB 6, 2020, View Source [SID1234553974]). This represents an increase of 1.6 percent as reported over the prior-year period, or 2.5 percent on a currency-neutral basis.

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BD also announced today that it is continuing to work with the U.S. Federal Drug Administration (FDA) on its software remediation plan for the Alaris System, which will require additional regulatory filings beyond what the company previously anticipated. The company expects to submit its comprehensive regulatory filing in the fourth quarter of fiscal year 2020. In the interim, the company will partner with the FDA and existing customers to ensure continued access to the Alaris System under medical necessity. As a result, the company is lowering its full fiscal year revenue and adjusted diluted earnings per share guidance.

"In the first quarter, the BD team delivered solid results, in line with our expectations," said Tom Polen, CEO and president. "As we look ahead to the balance of the fiscal year, we are focused on the resolution of the Alaris pump matter. We stand behind the safety of the Alaris System, which is used in the care of 70 percent of patients undergoing infusion therapy. Now, we need to take the necessary steps to meet the FDA’s expectations with respect to the Alaris System. We are committed to doing what is right for customers, patients and shareholders. You can expect that our purpose and values will always be at the core of who we are and how we work to resolve this situation moving forward."

First Quarter Fiscal 2020 Operating Results
As reported, diluted earnings per share for the first quarter were $0.87, compared with $2.05 in the prior-year period. This represents a decrease of 57.6 percent, and is primarily due to the gain on the sale of the Advanced Bioprocessing business in the prior-year period. Adjusted diluted earnings per share were $2.65, compared with $2.70 in the prior-year period. This represents a decrease in adjusted diluted earnings per share of 1.9 percent, or 0.4 percent on a currency-neutral basis.

Segment Results
In the BD Medical segment, as reported, worldwide revenues for the quarter of $2.090 billion decreased 2.1 percent from the prior-year period, or 1.1 percent on a currency-neutral basis. As anticipated, the segment’s results reflect growth in the Pharmaceutical Systems unit that was offset by declines in the Medication Management Solutions and Diabetes Care units and revenues in the Medication Delivery Solutions unit that were about flat when compared to the prior year.

In the BD Life Sciences segment, as reported, worldwide revenues for the quarter of $1.123 billion increased 6.4 percent over the prior-year period, or 7.4 percent on a currency-neutral basis. Revenue growth was driven by performance in the Biosciences and Diagnostic Systems units. BD Life Sciences’ growth was aided by flu-related revenues in the Diagnostic Systems unit as a result of a stronger flu season in comparison to the prior year.

In the BD Interventional segment, as reported, worldwide revenues for the quarter of $1.012 billion increased 4.4 percent over the prior-year period, or 5.0 percent on a currency-neutral basis. Revenue growth was driven by performance across the Surgery, Urology and Critical Care and Peripheral Intervention units.

Geographic Results
As reported, first quarter revenues in the U.S. of $2.430 billion increased 1.8 percent over the prior-year period. Growth in the U.S. was driven by performance in the Life Sciences and Interventional segments, partially offset by a decline in the Medical segment, as anticipated.

As reported, revenues outside of the U.S. of $1.795 billion increased 1.2 percent over the prior-year period, or 3.4 percent on a currency-neutral basis. International revenue growth was driven by performance in China and the Asia Pacific region.

Fiscal 2020 Outlook for Full Year
The company is lowering its full fiscal year 2020 revenue and adjusted diluted earnings per share guidance to reflect the impact of the remediation effort and anticipated loss of sales of the Alaris infusion system.

The company now expects full fiscal year 2020 revenues to increase 1.5 to 2.5 percent as reported, or 2.5 to 3.5 percent on a currency-neutral basis.

The company now expects full fiscal year 2020 adjusted diluted earnings per share to be between $11.90 and $12.10. This represents growth of approximately 4.0 to 5.5 percent on a currency-neutral basis over fiscal 2019 adjusted diluted earnings per share of $11.68, or growth of approximately 2.0 to 3.5 percent including the estimated unfavorable impact of foreign currency. Adjusted diluted earnings per share guidance includes an adverse impact of approximately 500 basis points related to the expiration of the Gore royalty.

Adjusted diluted earnings per share for fiscal 2020 excludes potential charges or gains that may be recorded during the fiscal year, such as, among other things, the non-cash amortization of intangible assets, acquisition-related charges, and certain tax matters. BD does not attempt to provide reconciliations of forward-looking non-GAAP earnings guidance to the comparable GAAP measure because the impact and timing of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of BD’s financial performance.

Conference Call Information
A conference call regarding BD’s first quarter results will be broadcast live on BD’s website, www.bd.com/investors, along with related slides, at 8:00 a.m. (ET) Thursday, February 6, 2020. The conference call will be available for replay on BD’s website, www.bd.com/investors, or at 1-800-585-8367 (domestic) and 1-404-537-3406 (international) through the close of business on Thursday, February 13, 2020, confirmation number 6886458.

On February 6, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic development and a developer of liquid biopsies reported consolidated financial results for the fiscal first quarter ended December 31, 2019 (Press release, Applied DNA Sciences, FEB 6, 2020, View Source [SID1234553927]).

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"During our fiscal first quarter, we made meaningful progress on our strategic priorities for fiscal 2020 to position the company for long-term growth while raising capital to support our growth strategy. Our revenue performance reflects a difficult comparison to the year-ago period, which included revenue related to a Department of Defense contract since completed, as well as our historical revenue pattern that troughs in the first quarter and builds over the balance of the year," stated Dr. James A. Hayward, president and CEO of Applied DNA.

"In our biotherapeutics business that utilizes our proprietary linear DNA production platform for application in adoptive cell therapies; DNA vaccines, such as cancer vaccines; CRISPR and other nucleic acid-based therapies, we continued to build proof points for a new paradigm in linear DNA production with our patented PCR processes ahead of traditional plasmids production. During the quarter, we signed an agreement with Tyme Technologies for our Vita-AssayTM invasive Circulating Tumor Cell ("iCTC") capture assay and services that enable Tyme to monitor disease progression in its pivotal trial for metastatic pancreatic cancer. In our industrials business that utilizes the same platform to illuminate supply chains in large commercial ecosystems for authenticity and traceability, the launch of Colorcon’s on-dose authentication platform powered by our taggant technology demonstrates execution of our pharmaceutical strategy to partner with Colorcon, who will be marketing the platform to its expansive customer base. Strategic progress has continued in this sector into our fiscal second quarter with our entry into the nutraceuticals market with a multi-year CertainT contract with Nutrition 21."

Concluded Dr. Hayward, "Looking ahead, we are placing greater emphasis on positioning our platform for biotherapeutic and diagnostic applications where there is a growing imperative for our capabilities while also nurturing key industrials applications to commercial-scale deployments. Our recently acquired liquid biopsy technology – the iCTC liquid biopsy platform – we believe allows us to detect primary cancer tumors often before they are visible to other diagnostic technologies, when preventive care for impending cancer may still be an option. Our iCTC platform is potentially transformative to cancer care, and our relationship with Tyme establishes a partnering model that is applicable to other companies pursuing therapies for such cancers as breast, pancreatic, ovarian, colorectal, among others, that we are actively pursuing."

Fiscal First Quarter 2020 Financial Results:

·Revenues decreased 28% for the first quarter of fiscal 2020 to $634 thousand, compared with $884 thousand reported in the same period of the prior fiscal year and decreased 62% from $1.7 million for the fourth quarter of fiscal 2019. This decrease in revenue year over year is due to a decrease of $167 thousand in service revenue and a decrease of $84 thousand in product revenues. The decrease in service revenues was primarily attributable to a decrease from a government contract award that ended during fiscal 2019. The decrease in product revenues was primarily related to a decrease of approximately $200 thousand in textiles, related to a cotton customer offset by an increase of $135 thousand in biopharmaceutical revenues.

·Total operating expenses decreased to $3.0 million for the first fiscal quarter of 2020, compared with $3.9 million in the prior fiscal year’s first quarter. This decrease was primarily attributable to an approximate $352 thousand decrease in payroll and a decrease of $93 thousand in consulting fees, which are both due to a realignment of the sales force and reductions in overall headcount. In addition, there was a decrease of $285 thousand in stock-based compensation expense and a reduction of $145 thousand in research and development expenses.

·Net loss for the quarter ended December 31, 2019 was $2.7 million, or $1.12 per share, compared with a net loss of $3.2 million, or $4.25 per share, for the quarter ended December 31, 2018, an improvement of 18%, and a net loss of $1.2 million, or $1.44 per share, for the quarter ended September 30, 2019.

·Excluding non-cash expenses, Adjusted EBITDA was negative $2.4 million and a negative $2.6 million for the quarters ended December 31, 2019 and 2018, respectively. See below for information regarding non-GAAP measures.

Select Recent Operational Highlights:

·On February 5, 2020, Applied DNA entered into an amendment to its existing joint development agreement with Takis S.R.L and Evvivax S.R.L.to include pre-clinical development of a potential linear DNA vaccine against 2019-nCoV, the new coronavirus;

·On January 27, 2020, Applied DNA bolstered its patent portfolio when the U.S. Patent and Trademark Office granted it a U.S. patent that covers methods of tagging man-made cellulosic fibers or materials during production and later authenticating the fiber or materials to confirm provenance and/or authenticity. This newly issued patent extends the Company’s addressable market within textiles to include cotton, synthetic fibers and materials, and, now, man-made cellulosic fibers and materials;

·On January 13, 2020, the Company announced a licensing agreement with LifeSensors, Inc. whereby it will incorporate LifeSensors’ high expression SUMO-fusion technologies into the Company’s linear DNA amplicons designed and produced for therapeutic applications. The Company believes that the incorporation of the SUMO-fusion technologies into Applied DNA’s linear amplicons may further optimize protein expression and deliver yet another strength to linear DNA; and

·On December 23, 2018, Colorcon, Inc., a world leader in the development and supply of film coating systems and excipients for pharmaceuticals, formally launched its On-Dose Authentication capability utilizing the Company’s technology to provide track and trace functionality for supply chain security. Applied DNA’s molecular taggants are integrated into Colorcon’s Opadry film coating system to significantly reduce the risks associated with the global problem of counterfeit and falsified medications entering the supply chain.

Fiscal First Quarter 2020 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal first quarter-end 2020 results on Thursday, February 6, 2020 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free:1-844-887-9402

·Participant Toll: 1-412-317-6798

·Please ask to be joined to the Applied DNA call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through February 7, 2020):

·Participant Toll Free: 1-877-344-7529

·Participant Toll: 1-412-317-0088

·Participant Passcode: 10138146

·Webcast replay: View Source

For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

On February 5, 2020 Genprex reported that after receiving the US Food and Drug Administration’s fast track designation last month for its immunogene therapy Oncoprex in combination with the EGFR tyrosine kinase inhibitor (TKI) osimertinib (AstraZeneca’s Tagrisso), the clinical-stage gene therapy company is prioritizing development of this therapy combination for EGFR-mutated non-small cell lung cancer and will start enrollment in Phase I/II clinical trials in mid-2020 (Press release, Genprex, FEB 5, 2020, View Source [SID1234553943]).

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Enrollment will start after the FDA accepts Genprex’s amendment to its investigational new drug application.

The company also said last month that it intends to start a new Phase I clinical trial investigating Oncoprex in combination with a checkpoint inhibitor. This is supported by preclinical studies indicating that TUSC2 increases the effectiveness of anti-PD1 checkpoint blockade combined with chemotherapy for lung metastases with KRAS and LKB1 mutations in mice.

Oncoprex is Genprex’s lead product candidate and it uses the active agent TUSC2 (Tumor Suppressor Candidate 2) gene combined with a lipid nanovesicle. TUSC2 has been shown to disrupt replication and proliferation of cancer cells, re-establish programmed cell death, as well as modulate the immune response against cancer cells. It’s also been observed to block mechanisms that create drug resistance.

Additionally, the company is putting its current Phase I/II trial investigating Oncoprex in combination with EGFR inhibitor erlotinib (Genentech/Roche’s Tarceva) ─ which provided support for the fast track designation ─ on hold, citing the reason that osimertinib is now considered the new standard of care of NSCLC patients with an EGFR mutation. Genprex has treated more than 50 lung cancer patients with Oncoprex in Phase I/II trials.

On February 6, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Seattle Genetics, FEB 6, 2020, View Source [SID1234553959]). The Company also highlighted ADCETRIS (brentuximab vedotin) and PADCEV (enfortumab vedotin-ejfv) commercial, regulatory and clinical development accomplishments and progress with its clinical programs for cancer, including tucatinib.

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"At the end of 2019, we became a multi-product oncology company following the rapid FDA approval of PADCEV for previously treated metastatic urothelial cancer patients, expanding our commercial portfolio into solid tumors," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "In addition, in collaboration with Takeda, global sales of ADCETRIS exceeded $1 billion in 2019, underscoring its importance in the treatment of multiple lymphomas. As we look ahead, subject to regulatory reviews, we are well positioned to bring a third product to market with the tucatinib marketing applications in the United States, Europe and other countries for patients with metastatic HER2-positive breast cancer. Importantly, across PADCEV, tucatinib and ADCETRIS, we are advancing broad clinical development programs intended to fully explore their potential. We are executing on our mission to develop transformative cancer therapies that make a meaningful difference in people’s lives."

ADCETRIS Program Highlights

Achieved ADCETRIS Sales Milestone: Seattle Genetics achieved a one-time $40 million milestone payment triggered by its collaborator Takeda surpassing annual net sales of $400 million in its territory during 2019. The milestone was recognized as royalty revenue in the fourth quarter of 2019.
Received New Indication in Canada: Health Canada approved ADCETRIS in combination with chemotherapy as frontline treatment for certain types of CD30-expressing peripheral T-cell lymphomas based on results of the phase 3 ECHELON-2 clinical trial.
Presented Fifteen Abstracts at ASH (Free ASH Whitepaper): ADCETRIS was featured in 15 data presentations at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting from both corporate and investigator-led clinical trials. A four-year update of the phase 3 ECHELON-1 clinical trial in advanced Hodgkin lymphoma demonstrated a sustained progression-free survival benefit for ADCETRIS in combination with AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) when compared to ABVD, which includes bleomycin. The presentations also highlighted data on ADCETRIS as monotherapy and as part of combination regimens in a range of CD30-expressing lymphomas.
PADCEV Program Highlights

Received FDA Approval for PADCEV: In December 2019, PADCEV received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. It is the first FDA-approved treatment for these patients. Seattle Genetics and Astellas are jointly commercializing PADCEV in the United States.
Completed Enrollment in Phase 3 EV-301 Clinical Trial: In January 2020, enrollment was completed in the phase 3 EV-301 clinical trial in metastatic urothelial cancer patients who previously received both platinum chemotherapy and a PD-1/L1 inhibitor. EV-301 is intended to serve as a confirmatory trial in the United States and support global marketing applications.
Initiated Phase 3 Clinical Trial in First-line Metastatic Urothelial Cancer: In January 2020, Seattle Genetics in collaboration with Astellas and Merck initiated the phase 3 EV-302 clinical trial evaluating the combination of PADCEV and Keytruda (pembrolizumab) with or without chemotherapy versus chemotherapy alone in patients with previously untreated locally advanced or metastatic urothelial cancer. The trial is expected to enroll 1,095 patients and the dual primary endpoints are progression-free survival and overall survival. The trial was initiated based on positive preliminary results from the phase 1 EV-103 clinical trial.
Initiated Phase 2 Clinical Trial in Solid Tumors: In January 2020, Seattle Genetics and Astellas initiated the phase 2 EV-202 clinical trial to evaluate single-agent PADCEV in a range of solid tumors, including non-small cell lung, head and neck, gastric/esophageal and breast cancers.
Tucatinib Program Highlights

Presented and Published HER2CLIMB Data: In December 2019, results were presented from the HER2CLIMB pivotal trial, which demonstrated that the combination of tucatinib with trastuzumab and capecitabine was superior to trastuzumab and capecitabine alone in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The trial met the primary endpoint of progression-free survival (PFS) and all secondary endpoints, including improvement in overall survival and improvement in PFS for patients with brain metastases at baseline. The tucatinib regimen was generally well-tolerated with a manageable safety profile. The results were presented at the 2019 San Antonio Breast Cancer Symposium and simultaneously published in the New England Journal of Medicine.
Received Breakthrough Therapy Designation: In December 2019, the FDA granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1 (ado-trastuzumab emtansine, Kadcyla). The designation was based on results from the HER2CLIMB pivotal trial.
Submitted Multiple Applications for Approval: In December 2019, Seattle Genetics completed its New Drug Application submission to the FDA under the Real Time Oncology Review (RTOR) pilot program. In January 2020, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and the submission was recently validated by the EMA. In addition, applications were recently submitted to regulators in Australia, Canada, Singapore and Switzerland under the FDA’s Project Orbis pilot program. The applications request approval of tucatinib based on positive results of the HER2CLIMB clinical trial.
Initiated Phase 3 HER2CLIMB-02 Clinical Trial: In October 2019, Seattle Genetics initiated the phase 3 HER2CLIMB-02 clinical trial of tucatinib versus placebo in combination with T-DM1 for patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab. HER2CLIMB-02 could support applications for potential approval in first- or second-line metastatic breast cancer.
Expanded MOUNTAINEER Clinical Trial: Seattle Genetics expanded the phase 2 MOUNTAINEER trial of tucatinib in combination with trastuzumab in metastatic colorectal cancer (CRC) to enroll up to approximately 110 patients to support potential accelerated approval of tucatinib in HER2-positive CRC.
Tisotumab Vedotin Program Highlights

Tisotumab Vedotin innovaTV 204 Pivotal Trial Data Expected in 2020: Seattle Genetics and Genmab expect to report topline data in the first half of 2020 from the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard-of-care treatment.
Other Recent Activities

ADC Collaborators Clinical and Regulatory Progress:
In January 2020, Roche received conditional marketing authorization from the European Commission for Polivy (polatuzumab vedotin) to treat patients with relapsed or refractory diffuse large B-cell lymphoma. Polivy utilizes Seattle Genetics’ proprietary antibody-drug conjugate (ADC) technology and as a result Seattle Genetics will receive a milestone payment from Roche. Seattle Genetics also receives royalties on global sales of Polivy.
In January 2020, GlaxoSmithKline (GSK) was granted priority review by the FDA for its Biologics License Application (BLA) and in February 2020 the EMA validated its MAA for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma. Belantamab mafodotin utilizes Seattle Genetics’ ADC technology. Additionally, GSK initiated a phase 3 clinical trial of belantamab mafodotin, triggering a development milestone payment to Seattle Genetics that was recognized as collaboration revenues in the fourth quarter of 2019.
Entered into License Agreement with BeiGene: Under the terms of the license agreement, BeiGene was granted exclusive rights to develop and commercialize a product candidate in Asia (except Japan) and the rest of the world. Seattle Genetics retained rights to the product candidate in the Americas, Europe and Japan. Seattle Genetics received a $20 million upfront payment and is eligible to receive progress-dependent milestones for a total potential deal value of up to $160 million and tiered royalties on any product sales.

FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS

Revenues: Total revenues in the fourth quarter and year ended December 31, 2019 increased to $289.8 million and $916.7 million, respectively, compared to $174.5 million and $654.7 million for the same periods in 2018. Revenues are comprised of the following three components:

Product Revenues: ADCETRIS net sales in the U.S. and Canada for the fourth quarter were $166.2 million, a 26 percent increase over net sales of $132.1 million in the fourth quarter of 2018. ADCETRIS net sales in the U.S. and Canada were $627.7 million for the full year in 2019, a 32 percent increase over net sales of $476.9 million in 2018. Growth over 2018 reflected ADCETRIS label expansions in 2018, which led to increased use primarily in frontline CD30-expressing PTCL following approval in November 2018. PADCEV was approved in the U.S. in late December 2019 and net sales for the fourth quarter were $0.2 million.
Royalty Revenues: Royalty revenues in the fourth quarter were $72.3 million, compared to $24.6 million in the fourth quarter of 2018. The fourth quarter of 2019 included a $40 million milestone from Takeda triggered by annual net sales exceeding $400 million in Takeda’s territory during 2019. Royalty revenues were $138.5 million for the full year in 2019, compared to $83.4 million in 2018. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser extent, sales of Polivy by Roche.
Collaboration and License Agreement Revenues: Amounts earned under the Company’s collaboration and license agreements were $51.1 million in the fourth quarter and $150.2 million for the full year in 2019, compared to $17.8 million and $94.4 million, respectively, for the same periods in 2018. In the fourth quarter of 2019, the Company recognized a milestone payment under its ADC collaboration with GSK and an upfront payment from BeiGene upon entering into a product licensing agreement.
Research and Development (R&D) Expenses: R&D expenses in the fourth quarter were $201.1 million, compared to $149.8 million in the fourth quarter of 2018. R&D expenses were $719.4 million for the full year in 2019, compared to $565.3 million in 2018. The increase in 2019 primarily reflected increased investment in the Company’s late-stage pipeline.

Selling, general and administrative (SG&A) Expenses: SG&A expenses in the fourth quarter were $115.2 million, compared to $79.5 million in the fourth quarter of 2018. SG&A expenses were $373.9 million for the full year in 2019, compared to $261.1 million for the same period in 2018. The increases were primarily attributed to costs to support commercialization efforts related to ADCETRIS frontline indications, launch preparation for PADCEV and tucatinib, as well as higher infrastructure costs to support the Company’s continued growth.

Cost of Sales: Cost of sales in the fourth quarter were $9.6 million, compared to $30.2 million in the fourth quarter of 2018. Cost of sales were $34.9 million for the full year in 2019, compared to $66.1 million for the same period in 2018. The 2018 periods reflected an inventory write-off of $18.1 million recorded in the fourth quarter of 2018 related to ADCETRIS in-process production that did not meet manufacturing specifications, as well as a reduction in amounts owed to certain third-party technology licensors.

Non-cash, share-based compensation cost for the full year in 2019 was $127.3 million, compared to $78.9 million for the same period in 2018.

Net Income / Loss: Net income for the fourth quarter of 2019 was $25.8 million, or $0.14 per diluted share, compared to a net loss of $119.8 million, or $0.75 per diluted share, for the fourth quarter of 2018. Net income in the fourth quarter of 2019 included net investment income of $64.2 million primarily associated with Seattle Genetics’ common stock holdings in Immunomedics, which are marked-to-market. For the full year in 2019, net loss was $158.7 million, or $0.96 per share, compared to a net loss of $222.7 million, or $1.41 per share, for the year in 2018. Net loss for the full year in 2019 included net investment income of $61.9 million primarily associated with Seattle Genetics’ common stock holdings in Immunomedics. Net loss for both the fourth quarter and the full year in 2018 included a non-cash income tax benefit of $23.7 million related to acquired intangible assets as part of the acquisition of Cascadian Therapeutics.

Cash and Investments: As of December 31, 2019, Seattle Genetics had $868.3 million in cash and investments. In addition, the Company held stock investments, primarily in Immunomedics common stock, valued at $163.9 million.

2020 FINANCIAL OUTLOOK

Seattle Genetics anticipates 2020 revenues, operating expenses and other costs to be in the ranges shown in the table below.

ADCETRIS net product sales

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast with supporting slides to discuss its fourth quarter and full year 2019 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event and supporting slides will be simultaneously webcast on the Seattle Genetics website at www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 800-353-6461 (domestic) or 334-323-0501 (international). The conference ID is 7290215. A replay of the live event and supporting slides will be available starting on February 6, 2020 on the Seattle Genetics website at www.seattlegenetics.com, under the Investors section, for at least 30 days. A replay of the audio only will be available by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 7290215. The telephone replay will be available until 5:00 p.m. PT on February 9, 2020.