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NanoString Highlights Groundbreaking Spatial Genomics Research Using Expanding Portfolio of GeoMx High-Plex RNA Atlas Products at 2020 Advances in Genome Biology and Technology (AGBT) Conference

On February 20, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported ten scientific studies utilizing the GeoMx Digital Spatial Profiler (DSP) that will be showcased at the 2020 Advances in the Genome Biology and Technology (AGBT) conference being held at the JW Marriott in Marco Island, Florida (Press release, NanoString Technologies, FEB 20, 2020, View Source [SID1234554572]). These studies span cancer translational research to neuroscience discovery applications, illustrating the platform’s flexibility and opportunity to spatially map distinct cell types and quantitate biological activity. NanoString will also be hosting the 2nd Annual Spatial Genomics Summit on Sunday, February 23rd from 12 – 4pm ET. Attendees do not need to be registered for AGBT to attend the Summit.

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The GeoMx Digital Spatial Profiler provides researchers high throughput, high multi-plex, spatial profiling of RNA and protein targets in a variety of sample types, including both fresh frozen and formalin-fixed, paraffin-embedded (FFPE) tissue sections. GeoMx DSP is currently available for read-out using NanoString’s nCounter Analysis System, allowing analysis of up to 96 proteins and 96 RNA targets. Beginning mid-2020, GeoMx DSP will be enabled to read-out on Illumina’s Next Generation Sequencers (NGS), which will increase the number of RNA targets that can be analyze by approximately twenty-fold. First NGS-enabled assay will be Cancer Transcriptome Atlas for human samples, which profiles more than 1,800 genes within oncology and immune pathways. This will be followed in 2021 with launch of the Whole Transcriptome Atlases for human and mouse.

"As one of the first labs in the world to have acquired the GeoMx DSP platform, we are enthusiastic about the potential to discover novel biology with the system," said Alex Swarbrick Ph.D., Garvan Institute of Medical Research, Sydney, Australia. "We used the GeoMx Whole Transcriptome Atlas to spatially characterize distinct cell types in triple negative breast cancer. These data allowed us to track the spatial heterogeneity of cancer signaling pathways and of T cell subsets, leading to insights inaccessible to bulk or single-cell RNA sequencing."

"2020 is shaping up to be the breakthrough year for spatial biology," said Brad Gray, president and CEO of NanoString. "At the AGBT conference, researchers will highlight the powerful new capabilities that will be unlocked using NGS read-out, including our Cancer Transcriptome and Whole Transcriptome Atlases. I’d like to thank all of our customers and collaborators that have worked so diligently to make such groundbreaking research a reality."

At AGBT 2020, studies performed by leading academic researcher centers demonstrate three major applications for GeoMx DSP:

Discovering novel spatial biomarkers that are not readily detectable by traditional bulk profiling

Spatial landscape of the immune microenvironment in metastatic prostate cancer using GeoMx Digital Spatial Profiler
Pete Nelson, MD, et al., Fred Hutchinson Cancer Research Center, Seattle, WA USA
Used GeoMx DSP Cancer Transcriptome Atlas to interrogate tissue microarrays of metastatic prostate cancer samples and characterize immune responses. Spatial analysis revealed intra-patient heterogeneity that would not have been readily apparent from bulk RNA profiling experiments.

Spatial proteomic characterization of the tumor and immune microenvironment reveals features associated with response to neoadjuvant HER2-targeted therapy
Katherine McNamara et al., Stanford University, Palo Alto, CA, USA
Used spatial proteomic analysis of biopsies from on-treatment HER2+ breast cancer patients to stratify responders v. non-responders early during a course of neoadjuvant HER2-targeted therapy. GeoMx analysis allowed unique segmentation of cell populations to provide insight into the effect of innate immune markers, ER status, and PAM50 subtype on treatment response.

Identification of cell type-specific RNA biomarker candidates in melanocytic tumors using GeoMx Digital Spatial Profiling
Maija Kiuru, MD, Ph.D., University of California, Davis, CA, USA
GeoMx Cancer Transcriptome Atlas analysis revealed microenvironment-specific expression of a novel cell-type specific biomarker, DAMP, in response to early melanoma development. This marker may allow for more sensitive detection of melanoma via patch biopsy.

Single-nucleus RNA-seq reveals distinct intratumoral transcriptomic heterogeneity in treatment-naïve and chemoradiotherapy-treated primary pancreatic ductal adenocarcinoma
William Hwang, MD, Ph.D., et al. et al., Broad Institute, Cambridge, MA, USA
GeoMx Cancer Transcriptome Atlas and Whole Transcriptome Atlas applications were used to profile tumor, fibroblast, and immune compartments in Pancreatic ductal adenocarcinoma (PDAC) samples from twelve patients. Differential gene expression was measured in tumor and fibroblast compartments between treatment groups and by levels of immune infiltration.

Spatial Profiling of the Immune Landscape of Solid Tumors Treated with Low Dose Radiation and Immunotherapy Using High Plex RNA Profiling with the GeoMx Platform
Krisztian Homicsko, MD, Ph.D., et al., Ludwig Institute for Cancer Research, Lausanne, Switzerland
This project interrogated gene expression changes associated with low-dose radiation immunogenic induction therapy in ovarian cancer. GeoMx Cancer Transcriptome Atlas analysis revealed a pretreatment microenvironment associated with favorable response to therapy, and allowed in depth analysis of needle core biopsies, providing important spatial information in samples that would not have been ideal for bulk transcriptomic assays.

Localizing and quantifying the immune contexture of human glioma with GeoMx high -plex RNA profiling
Troy McEachron, MD, et al., University of Southern California, Los Angeles, CA, USA
Combined single cell RNA sequencing with GeoMx Cancer Transcriptome Atlas analysis to characterize immune cell distribution in glioma samples. GeoMx DSP demonstrates that synchronizing digital pathology and bioinformatics provides layers of insight that conventional methods couldn’t.

Spatial mapping of the whole transcriptome in FFPE tissue

Neural stem cell differentiation trajectories in the developing human brain revealed by whole-transcriptome in situ spatial profiling
Kenny Roberts, MD, Ph.D., et al. et al., Sanger Institute, Cambridge, UK
GeoMx DSP Whole Transcriptome Atlas was used to distinguish the transcriptomic profiles of neural stem cells, intermediate progenitors and neurons in the fetal human cerebral cortex at 14 and 19 post-conception weeks. This study examined cell type specific gene expression programs throughout the cortical germinal zones, subplate and the maturing cortical plate and identified spatiotemporal gene expression correlated with neural stem cell self-renewal and differentiation.

Single Cell Programs of Immune Activation in Human MSI vs MSS Colorectal Carcinoma
Jonathan Chen, MD, Ph.D., et al. et al., Broad Institute, Cambridge, MA, USA
GeoMx DSP Cancer Transcriptome Atlas and Whole Transcriptome Atlas were used to interrogate how tumor and microenvironment interactions vary spatially within colorectal cancers, allowing spatial mapping of signatures linked to single cell RNA sequencing. This study highlights the capacity of GeoMx to identify locations of specific cell populations distributed across tissues.

Measuring the Spatial Whole Transcriptome and High-Plex Proteins on FFPE samples from Glioblastoma Multiforme Immunotherapy Clinical Trials Using Digital Spatial Profiling

Yue Lu Ph.D., et al., Institute Systems Biology, Seattle, WA, USA
GeoMx Cancer Transcriptome Atlas analysis of glioblastoma multiforme (GBM) samples generated a high-resolution spatial map of the tumor microenvironment and provided the framework for creating a GBM tumor atlas. Use of whole transcriptome sequencing combined with spatial analysis provides the potential to discover the biology underpinning response to new immunotherapy treatment for glioblastoma.

Phenotyping of single cells through spatial profiling algorithms

Mapping intratumoural heterogeneity of triple negative breast cancer through integrated single cell RNA-Sequencing and whole transcriptome Digital Spatial Profiling
Alex Swarbrick Ph.D. et al., Garvan Institute of Medical Research, Sydney, Australia
Primary, untreated, triple negative breast cancer (TNBC) was profiled using GeoMx DSP whole transcriptome. Segmentation was performed based on visual markers characterize immune and stromal cells in the invasive edge, tumor core, and distant stromal regions with the goal of discovering novel therapeutic targets in TNBC.

Updating immune cell deconvolution for the spatial genomics era
Danaher Ph.D. et al., NanoString Technologies, Seattle, WA USA
GeoMx DSP Cancer Transcriptome Atlas was used to estimate abundance of different immune cell types using novel computational methods. This allows researchers to study how immune cells interact spatially in different regions of a tissue.

Enabling pathway analysis of RNA expression in formalin-fixed paraffin embedded tissues with the GeoMx DSP Platform.
Boykin et al., NanoString Technologies, Seattle, WA USA
GeoMx Cancer Transcriptome Atlas, bulk RNA sequencing, and NanoString nCounter analysis was used to profile the same samples. This project demonstrates how GeoMx analysis can be expanded beyond single gene analysis to understand how biological pathways vary spatially in different regions of a tissue.

NanoString is currently accepting applications to a Technology Access Program for its Cancer Transcriptome Atlas using the DSP technology at [email protected].

To learn more about GeoMx DSP, please visit View Source

HARPOON THERAPEUTICS TO PARTICIPATE IN TWO UPCOMING INVESTOR CONFERENCES

On February 20, 2020 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that Gerald McMahon, Ph.D., President and Chief Executive Officer, will participate in two upcoming investor conferences (Press release, Harpoon Therapeutics, FEB 20, 2020, View Source [SID1234554570]):

A fireside chat at the SVB Leerink 9th Annual Global Healthcare Conference in New York on February 26, 2020 at 1 p.m. ET / 10 a.m. PT; and

A presentation at the Cowen and Company 40th Annual Health Care Conference in Boston on March 2, 2020 at 1:30 p.m. ET / 10:30 a.m. PT.
A live audio webcast of the fireside chat and presentation will be available in the Investors section of Harpoon Therapeutics’ website at www.harpoontx.com.

argenx to report full year 2019 financial results and fourth quarter business update on February 27, 2020

On February 20, 2020 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that it will host a conference call and audio webcast on Thursday, February 27, 2020 at 3:00 pm CET (9:00 am ET) to discuss its 2019 financial results and provide a fourth quarter business update (Press release, argenx, FEB 20, 2020, View Source [SID1234554569]).

To participate in the conference call, please select your phone number below and use the confirmation code 2484158. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

A replay of the webcast will also be available at the argenx website.

Reata Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2019 Financials and Provides an Update on Development Programs

On February 20, 2020 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and full year ended December 31, 2019, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, FEB 20, 2020, View Source;source=gmail&ust=1582354855075000&usg=AFQjCNHkerl-gpEGVj67JhlxLel2BJQtHw [SID1234554566]).

"In 2019, we made significant progress toward our goal of becoming a global, fully-integrated biopharmaceutical company," said Warren Huff, Reata’s Chief Executive Officer and President. "We announced positive, pivotal data from our lead franchises, chronic kidney disease (CKD) and neurology, and are actively preparing for commercial launch in the United States and abroad for bardoxolone methyl (bardoxolone) in CKD caused by Alport syndrome, and omaveloxolone in Friedreich’s ataxia, two severe and life-threatening diseases without approved therapies. We also successfully capitalized the Company to fund the development of our pipeline assets and advance our lead drug candidates and early-stage drug candidates into new indications with high unmet need."

Reata 2019 Pipeline Highlights

Reported positive data from the pivotal part 2 portion of the Phase 2 MOXIe study of omaveloxolone in patients with Friedreich’s ataxia.
Reported positive data from year one of the pivotal Phase 3 portion of the CARDINAL study of bardoxolone in patients with CKD caused by Alport syndrome.
Launched the pivotal, global Phase 3 FALCON study of bardoxolone in patients with CKD caused by autosomal dominant polycystic kidney disease (ADPKD).
Completed enrollment in the pivotal Phase 3 CATALYST study of bardoxolone in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH).
Reata 2019 Corporate Highlights

Reacquired the development, manufacturing, and commercialization rights concerning our proprietary Nrf2 activator product platform, including bardoxolone and omaveloxolone, originally licensed to AbbVie, Inc. (AbbVie) for territories outside of the United States and excluding, for bardoxolone, certain Asian countries previously licensed to Kyowa Kirin Co., Ltd. (KKC).
Completed an underwritten public offering of 2,760,000 shares of Class A common stock at a price to the public of $183.00 per share, resulting in gross proceeds of $505 million.
Fourth Quarter Financial Highlights

Cash and Cash Equivalents

At December 31, 2019, we had cash and cash equivalents of $664.3 million, as compared to $337.8 million at December 31, 2018.

GAAP and Non-GAAP Net Loss

The net loss according to generally accepted accounting principles in the U.S. (GAAP) for the fourth quarter of 2019 was $186.9 million, or $5.91 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $25.6 million, $0.86 per share, on both a basic and diluted basis, for the same period of the year prior. For the twelve months ended December 31, 2019, the GAAP net loss was $290.2 million, or $9.54 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $80.5 million, or $2.91 per share, on both a basic and diluted basis, for the same period of the year prior.

The increase in GAAP net loss is driven primarily by a Reacquired license right expense of $124.4 million related to the amended and restated license agreement we entered into with AbbVie in October 2019 (Reacquisition Agreement) to reacquire the development, manufacturing, and commercialization rights concerning our proprietary Nrf2 activator product platform, as well as increases in stock based compensation expense related to the growth of our personnel.

The non-GAAP net loss for the fourth quarter of 2019 was $50.3 million, or $1.59 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $22.8 million, $0.77 per share, on both a basic and diluted basis, for the same period of the year prior. For the twelve months ended December 31, 2019, the non-GAAP net loss was $139.4 million, or $4.58 per share, on both a basic and diluted basis, as compared to a non-GAAP net loss of $70.0 million, or $2.53 per share, on both a basic and diluted basis, for the same period of the year prior.

The non-GAAP net loss excludes stock-based compensation and reacquired license rights expense. See "Use of Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP net loss appearing later in the press release.

Revenue

Revenue was $2.7 million in the fourth quarter of 2019, as compared $8.5 million for the same period of the year prior. Revenue for the fourth quarter of 2019 included $0.7 million from the AbbVie collaboration agreement, $1.2 million from the KKC license agreement, and $0.8 million from other sources. Revenue was $26.5 million for the twelve months ended December 31, 2019, as compared to $53.6 million, for the same period of the year prior. Revenue for the twelve months ended December 31, 2019 included $20.6 million from the AbbVie collaboration agreement, $4.7 million from the KKC license agreement, and $1.2 million from other sources.

GAAP and Non-GAAP Research and Development (R&D) Expenses

GAAP R&D expenses were $40.2 million for the fourth quarter of 2019, as compared to $25.3 million, for the same period of the year prior. GAAP R&D expenses were $128.1 million for the twelve months ended December 31, 2019, as compared to $97.3 million, for the same period of the year prior.

Non-GAAP R&D expenses were $36.7 million for the fourth quarter of 2019, as compared to $24.3 million, for the same period of the year prior. Non-GAAP R&D expenses were $119.4 million for the twelve months ended December 31, 2019, as compared to $93.3 million, for the same period of the year prior.

The non-GAAP R&D expenses exclude stock-based compensation expense. See "Use of Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses appearing later in the press release.

GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $22.3 million for the fourth quarter of 2019, as compared to $7.9 million, for the same period of the year prior. GAAP G&A expenses were $58.3 million for the twelve months ended December 31, 2019, as compared to $32.7 million, for the same period of the year prior.

Non-GAAP G&A expenses were $13.4 million for the fourth quarter of 2019, as compared to $6.2 million, for the same period of the year prior. Non-GAAP G&A expenses were $40.6 million for the twelve months ended December 31, 2019, as compared to $26.1 million, for the same period of the year prior.

The non-GAAP G&A expenses excludes stock-based compensation expense. See "Use of Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP G&A expenses appearing later in the press release.

Operating Capital Requirements

We believe our existing cash and cash equivalents will be sufficient to enable us to fund our operations through the end of 2021.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The Company defines non-GAAP R&D expenses as GAAP R&D expenses less stock-based compensation expense, non-GAAP G&A expenses as GAAP G&A expenses less stock-based compensation expense, non-GAAP operating expenses as GAAP operating expenses less stock-based compensation expense and reacquired license rights expense, non-GAAP net loss as GAAP net loss plus stock-based compensation expense and reacquired license rights expense and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted plus stock-based compensation expense and reacquired license rights expense. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of reacquired license rights expense because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods.

Because management believes certain items such as stock-based compensation expense and reacquired license rights expense can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.

The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

Bavarian Nordic Announces Annual Report 2019

On February 20, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its Annual Report for 2019 (Press release, Bavarian Nordic, FEB 20, 2020, View Source [SID1234554565]). Below is a summary of business progress, financial performance for the year and financial outlook for 2020. The full report is attached as a PDF file and can be found on the company’s website, www.bavarian-nordic.com.

A year of transformation
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "2019 was a decisive year for Bavarian Nordic with several important events that have reshaped the Company towards fulfilling our vision. In particular, the FDA approval of JYNNEOS and our acquisition of Rabipur/RabAvert and Encepur from GlaxoSmithKline were two significant game-changers for us as we are now transitioning into a commercial vaccine company with a solid cash flow generation, allowing us to continue investments in our pipeline to bring additional life-saving products to the market. By establishing commercial operations, we will become a full-fledged company leveraging our existing strengths in R&D and manufacturing with an ambition to deliver sustainable profitability. To succeed in this endeavor, we have strengthened our leadership team with experienced people in commercial and R&D and will also be inviting many new colleagues to join us on this exciting journey."

Important events after the balance sheet date

In January 2020, we completed the sale of the Priority Review Voucher, granted by the FDA in connection with the approval of JYNNEOS in 2019. Net proceeds from the sale were DKK 620 million.
In November 2019, we strengthened our leadership team with the appointment of Jean-Christophe (JC) May as Executive Vice President and Chief Commercial Officer, who took up his position in January 2020. Based in a newly established office in Zug, Switzerland, he is heading our commercial organization, which is being ramped up to secure a successful transition of sales and marketing responsibilities for the acquired vaccines, as well to grow the market for our monkeypox vaccine.
Our leadership team was further strengthened with the appointment in January 2020 of Laurence De Moerlooze as Executive Vice President and Chief Medical Officer, who will take up her position in April 2020. She is joining the Company from Takeda Vaccines where she currently serves as Vice President and Global Program Lead for vaccines against Zika virus and Norovirus and has previously worked at GSK for more than 15 years, holding various leading roles in medical affairs and vaccine development working with numerous life-saving vaccines including Rabipur/RabAvert and Encepur.
During the first quarter of 2020, we will transfer our headquarters to Hellerup near Copenhagen in order to allow for the further expansion of the manufacturing facility in Kvistgaard, as we scale up and expand our manufacturing activities to incorporate the acquired vaccines, as well as launch our new fill and finish facility.
Strategy and short-term goals
By 2025, we aspire to be one of the largest pure play vaccines companies, improving and saving lives by excelling in R&D innovation, manufacturing and commercialization. To drive forward our ambitions for growth, we have outlined the following three strategic pillars along with our mid- to long-term goals in the annual report:

A company driven by Commercial excellence
Develop Innovative and lifesaving vaccines
Best-in-class vaccine Manufacturer
The key strategic activities and milestones in 2020 for each strategic area include:

A company driven by Commercial excellence

Assume full sales and marketing responsibility for Rabipur/RabAvert and Encepur from GlaxoSmithKline
Establish a full commercial organization to support Rabipur/RabAvert, Encepur and JYNNEOS for the monkeypox indication
Take over physical distribution of Rabipur/RabAvert and Encepur in selected markets
Increase awareness and establish a new market for the monkeypox indication
Develop Innovative and lifesaving vaccines

Continue preparations for initiation of the Phase 3 trial of MVA-BN RSV in the elderly in 2021
Advance the Phase 3 trial of smallpox MVA-BN freeze-dried formulation
Obtain successful marketing authorization of Ebola vaccine MVA-BN Filo in the EEA (partnered with Janssen)
Establish proof-of-concept for BN-Brachyury in chordoma
Explore intra-tumoral/intravenous administration within immunotherapy
Best-in-class vaccine Manufacturer

Complete the qualification and validation of the newly built fill and finish facility
Commence investment in expansion of vaccine bulk manufacturing
Commence the manufacturing technology transfer of Rabipur/RabAvert and Encepur
Financial performance
Bavarian Nordic achieved its planned goals for 2019 and outperformed compared to guidance on revenue and earnings before interest and tax (EBIT).

Revenues were DKK 662 million, compared to a guidance of DKK 600 million as more revenue was recognized on the BARDA funding to support qualification and validation of the new fill and finish facility. Revenue from product sales was DKK 324 million and revenue from ongoing development contracts was DKK 338 million.

The result before interest and tax (EBIT) was a loss of DKK 328 million, compared to a guided loss of DKK 360 million.

The cash preparedness at year-end was DKK 716 million, compared to a guidance of DKK 700 million, and was composed of DKK 472 million in cash, cash equivalents and investments in securities and DKK 244 million in undrawn credit lines.

For a detailed financial review, see the annual report.

DKK million USD million*
2019 guidance actual guidance actual
Revenue 600 662 90 99
EBIT (360) (328) (54) (49)
Cash preparedness, year-end** 700 716 105 107

* Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.68 per 1.00 USD, which was the exchange rate as of December 31, 2019.
** Cash preparedness includes cash, cash equivalents, investments in securities and the aggregate amount of undrawn credit lines.

Outlook for 2020
The acquisition of Rabipur/RabAvert and Encepur will have a significant positive impact on Bavarian Nordic’s revenue, as the vaccines will become the primary revenue driver. In 2019, GlaxoSmithKline posted revenues of approximately DKK 1,490 million from combined sales of the vaccines, compared to Bavarian Nordic’s estimate of approximately DKK 1,300 million. The higher revenue is primarily ascribed to better performance for Rabipur/RabAvert, which has benefitted from competitor stock-outs during 2019 and is not considered to reoccur in the short term. Bavarian Nordic does not anticipate stock-outs to affect the sales in 2020 and thus maintain expectations to grow combined sales of the new products by a low-to-mid single digit rate annually from the previous estimated 2019 level.

2020E (all numbers are approximate) DKK million USD million
Revenue 1,900 288
EBITDA 675 102
Cash and cash equivalents, year-end 1,350 205
In addition to sales from Rabipur/RabAvert and Encepur the guidance also assumes revenue from our smallpox vaccine business, a milestone payment from Janssen related to expected EMA approval of the Ebola vaccine and other revenue from contract work. The smallpox revenue mainly relates to sales from uncommitted contracts, but also includes committed contract work related to the ongoing Phase 3 study of the freeze-dried smallpox vaccine and validation of the new fill and finish facility. The revenue assumptions are based on currency exchange rates of DKK 6.60 per 1 USD and DKK 7.45 per 1 EUR.

Net proceeds of DKK 620 million from the sale of the Priority Review Voucher, granted to the Company by the FDA in connection with the approval of JYNNEOS in 2019, were received in January 2020 and will be recognized as other operating income in the consolidated financial statements for 2020.

Research and development costs of approximately DKK 500 million are expected for 2020, of which approximately DKK 150 million are expected to be recognized as production costs as the investment is deployed towards contract work.

See the annual report for a full description of assumptions for the 2020 guidance.

Rights issue in first half 2020
To support the acquisition of Rabipur/RabAvert and Encepur, including repayment of the bridge financing provided by Citi and Nordea, the Company is planning a rights issue on Nasdaq Copenhagen in the first half of 2020. The rights issue, which has been approved by the Company’s shareholders, is fully underwritten by Citi and Nordea as Joint Global Coordinators.

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) to present the annual results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 9168708.