On April 14, 2020 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the first quarter of fiscal year 2020 and withdrew its 2020 guidance (Press release, Illumina, APR 14, 2020, View Source [SID1234556321]).

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Subject to quarter-end closing adjustments, the Company expects to report first quarter revenue of approximately $858 million, compared to $846 million in the first quarter of 2019. Strong sequencing consumable revenue more than offset the impact of COVID-19 including disrupted system sales in the closing weeks of the quarter.

"Our priority in the midst of this global pandemic is the safety of our employees, partners and customers," said Francis deSouza, President and CEO. "We are also committed to ensuring continuity of supply for our customers, many of whom are performing critical clinical testing for patients. We share the commitment of the scientific community to do everything we can to fight COVID-19, and are supporting researchers using sequencing to track transmission, study the evolution of the virus’ genome and how it could impact the effectiveness of diagnostics and therapies, or explore how surveillance could be adopted to reduce the impact of future outbreaks of new infectious diseases."

"While our preliminary first quarter results were strong overall, we expect the second quarter to be significantly impacted by COVID-19 related disruption," said Sam Samad, Illumina’s Chief Financial Officer. "We are confident that this is a temporary disruption that in no way alters the long-term trajectory of sequencing adoption and demand. That said, it is not possible at this time to forecast the severity and duration of this outbreak. As a result, we believe it is prudent at this time to withdraw our 2020 revenue and earnings per share guidance."

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, April 30, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597, or 1 (647) 689-6853 outside North America, both with conference ID 9492366.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On April 14, 2020 NOXXON Pharma N.V. (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that its poster titled "Phase 1/2 study with CXCL12 inhibitor NOX-A12 and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer" has been selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting 2020 (Press release, NOXXON, APR 14, 2020, View Source [SID1234556320]). The presentation will include a short video and commentary by the first author, Dr. Niels Halama, from National Center for Tumor Diseases (NCT) in Heidelberg, Germany, who will present the latest pharmacodynamic, safety, survival and more mature clinical data from the trial.

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The presentation will be freely available upon registration on the AACR (Free AACR Whitepaper) website in the Virtual Poster Session section as of Monday, April 27, 2020, 06.00 p.m. CEST. The abstract will be posted online to the AACR (Free AACR Whitepaper) website on Monday, April 27, 2020.

On April 6, 2020, the Board of Directors of the AACR (Free AACR Whitepaper) had announced that due to the COVID-19 outbreak it would not organize an in-person Annual Meeting in 2020, originally scheduled for April 24-29 in San Diego, California. Instead, the AACR (Free AACR Whitepaper) will feature selected program and presentations in Virtual Annual Meetings, on April 27-28 and June 22-24.

On April 14, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of their Pharma Research Solutions, the latest expansion of the company’s portfolio of comprehensive genomics assays and analytics (Press release, Personalis, APR 14, 2020, View Source [SID1234556319]). These solutions, which leverage Personalis’ patented ACE Technology, are designed for use in early drug discovery and preclinical studies in oncology, but also other disease areas. These offerings complement Personalis’ comprehensive immunogenomics platform, ImmunoID NeXT, which is currently used for clinical biomarker and companion diagnostic development in translational research and clinical trials by the company’s pharmaceutical partners.

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"Our Pharma Research Solutions provide our customers with access to a broad suite of both proprietary and standard assays from targeted DNA and RNA panels through to whole genome and whole exome and transcriptome services. Our expansive sample processing and sequencing capacity, combined with our experience and expertise in executing large-scale projects as part of biopharma oncology clinical trials as well as the VA Million Veterans Program, makes us the ideal partner for pharmaceutical companies aiming to harmonize their genomics strategy across all preclinical and clinical programs," said John West, CEO of Personalis. "Additionally, we have seen increasing interest amongst our pharma partners in leveraging ImmunoID NeXT and other solutions in areas such as inflammatory disease and other genetic disorders. This represents both the broad applicability of our technology and a potentially large growth opportunity for our business."

The Pharma Research Solutions integrate Personalis’ ACE Technology to improve sequencing performance in complex, difficult-to-sequence regions of the genome that are insufficiently covered by conventional NGS approaches. The assays and bioinformatics capabilities offered by Personalis’ Pharma Research Solutions can enable the identification of novel drug targets and the generation of deeper insights into drug candidates’ mechanisms of action and associated resistance mechanisms in human and non-human models — in a cost-effective and highly-scalable manner. These solutions also facilitate the company’s pursuit of new, large-scale population sequencing projects. Every step in the process from nucleic acid extraction and library preparation through to sequencing is performed in a CLIA-certified/CAP-accredited laboratory, with downstream analysis conducted using a framework of advanced algorithms.

On April 14, 2020 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company, reported its full year 2019 financial results (Press release, MEDIAN Technologies, APR 14, 2020, View Source [SID1234556318]). Median Technologies’ Board of Directors approved the consolidated 2019 financial statements on April 9, 2020.

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As of December 31, 2019, revenue reached €9m, an increase of 41% compared with 2018 revenue of €6.5m. The Company’s quarter-on-quarter revenue growth was steady across 2019, confirming the growth momentum already seen during the second half of 2018. In total, business continued to grow steadily over six quarters, with average quarterly growth of 13.8%. Company revenue was entirely generated by the iCRO business unit, which delivers solutions and services for medical image management in oncology clinical trials. The iBiopsy business unit is not generating revenue at this stage, as it currently only includes Research and Development activities.

As of December 31, 2019, the order backlog for the iCRO business unit stood at €38.3m, an increase of 24.8% compared with the order backlog as of June 30, 2019 and of 61.6% compared with the order backlog as of December 31, 2018.

Selected financial information (IFRS consolidated financial statements)

In 2019, Median’s average headcount was 87 employees, with an acceleration in the pace of recruitment during the second half of 2019: as of December 31, the Company’s headcount stood at 106 employees.

Cash and cash equivalents as of December 31, 2019 were €7.6m, versus €12.7m as of December 31, 2018. Cash expenditure was €0.4m per month for 2019 as a whole. This broke down into €0.8m per month during the first half of the year and €0.3m per month during the second half, excluding the favorable impact of the Research Tax Credit.

Taking these items into account, the Company reported a net loss of €8m, compared with €15.3m in 2018, marking a major decrease of 48%.

2019: stabilization of the iBiopsy technology and record business for the iCRO business unit

iBiopsy: in 2019, Median stepped up its Research and Development activities, with total expenditure of €4.7m, of which a significant share for its imaging phenomics platform iBiopsy. Based on the most advanced AI technology and data science, iBiopsy will, using imaging biomarkers, identify in an innovative manner the specific signatures of certain diseases for their early detection, the quantification of their severity and their monitoring.

During the year, new proprietary extraction solutions for information "hidden" in medical imaging have been developed and optimized in two indications: primary liver cancer (HCC – Hepatocellular Carcinoma), the fourth leading cause of death by cancer worldwide; and hepatic fibrosis in the clinical context of NASH (Non-alcoholic Steatohepatitis), a disease whose prevalence is significantly increasing worldwide. These results were presented during prestigious international conventions and congresses in the United States and Europe.

Median has also developed its technology base and has started to roll out its system on a large scale with a cloud architecture that allows the real-time identification of biomarkers.

A €35m financing agreement with the European Investment Bank (EIB) was signed on December 18, 2019.

Imaging solutions and services for clinical trials (iCRO): 2019 was a record year for the iCRO business unit. The iCRO activity reached breakeven at the end of the first half of 2019 and demonstrated that it is a profitable business with sustainable growth.

In 2019, the iCRO BU continued its growth in China through its WFOE (Wholly Foreign Owned Enterprise) in Shanghai, which has become an operational structure providing local services to biopharmaceutical companies. At end-2019, 56% of the order backlog related to Chinese projects, compared with 39.2% at end-2018.

Median has also largely exceeded its 2019 objectives for Europe and the United States, thanks to a specific and particularly profitable strategy of developing sales based on the recurrence of contracts. This highlights the increased trust in the execution of projects as well as the competitiveness and quality of Median’s services. Across the year as a whole, the quality of services was validated by 12 successful customer audits and one FDA (Food and Drug Administration) audit relating to a major Phase III trial of a Top 3 pharma company.

2020 outlook, excluding the impact of COVID-19

iBiopsy: the 2020 roadmap for iBiopsy will focus on the clinical development plan, product roadmap, clinical and technological strategic partnerships, supported by an intellectual property protection strategy. The first tranche of the loan (€15m of a total €35m) granted by the EIB to Median Technologies will be released before the end of the first half of 2020. In view of this secure financing by the EIB, Median started, as of the beginning of 2020, to step up its investment program and recruitment plan. In 2020, external investments will mainly relate to access to data for clinical approvals on large cohorts and the implementation of the intellectual property protection strategy.

iCRO: the iCRO business should enjoy sustained growth thanks to the conversion of its growing order backlog and its positioning on the Chinese market. The autonomy of Median’s subsidiary in China should continue to increase in 2020. The Company intends to strengthen its iCRO operational teams and sales force across the board.

A review of the COVID-19 situation

In anticipation of the lockdown measures taken by the French government on March 17, 2020 due to the COVID-19 public health crisis, Median instructed all of its French-based employees to work from home as of March 16. The Company’s business continuity has been secured since this date. Median operates globally via cloud-based infrastructures which are used daily to deliver imaging solutions (iCRO) to its customers under normal conditions; services therefore continue to be provided as usual.

iCRO: the start of the public health crisis in China led to delays in February in the reception of images from Chinese hospitals for clinical trials that were already underway. The start dates for new trials in the order backlog were also postponed, leading to a delay to inflows for the Company. The situation was almost entirely back to normal in March.

With the spread of the pandemic in March to Europe and then to the United States, the same impacts have been seen and have generated a delay to inflows since mid-March.

Revenue for the first quarter of 2020 should nonetheless improve compared with the fourth quarter of 2019. A press release announcing 2020 first quarter results will be published shortly. This press release will also provide an overview of the company’s strategy with regard to COVID-19.

Considering the uncertainty surrounding the progression of the public health crisis, it is too soon to provide revenue forecasts for the second quarter. Nevertheless, for 2020 as a whole, Median Technologies expects the impact of the COVID-19 crisis on its iCRO business to be limited.

iBiopsy: research and development activities relating to iBiopsy continue as normal thanks to the development infrastructure that has been in place for several months and which is used on a daily basis under normal conditions. The drawing down of the first tranche of the EIB’s loan shall take place, as initially planned, during the first half of the year.

"The excellent performance of Median’s iCRO business validates the strategic decisions which we made in 2018. We are thrilled to see that this business has become profitable and enjoys sustainable growth. Despite the COVID-19 situation, we expect this momentum to continue in 2020. At the same time, the volume of our order backlog makes us confident in our ability to achieve our 2020 revenue target" said Fredrik Brag, CEO and co-founder of Median Technologies. "In terms of iBiopsy, like the collaboration agreement announced with AP-HP on March 2, we expect 2020 to bring partnerships and clinical data that will enable the large-scale clinical validation of our approach for certain therapeutic indications", Fredrik Brag added.

On April 14, 2020 Lantheus Holdings, Inc. (NASDAQ: LNTH) ("Lantheus"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, and Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, reported that Lantheus has entered into a Support Agreement (the "Support Agreement") with Velan Capital ("Velan") in connection with the proposed merger of Lantheus and Progenics (Press release, Lantheus Medical Imaging, APR 14, 2020, View Source [SID1234556317]).

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Velan is a stockholder of both Progenics and Lantheus and the Support Agreement provides that Velan will vote all of its Progenics stock and Lantheus stock in favor of the proposed merger of Lantheus and Progenics on the terms set forth in the Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the "Amended Merger Agreement"). Velan has also agreed to abide by certain customary standstill provisions during the term of the Support Agreement.

In 2019, Velan led a successful consent solicitation campaign that resulted in the resignation of Progenics Chief Executive Officer Mark Baker and the seating of five new independent directors on the reconstituted seven-member Progenics Board of Directors. Progenics’ reconstituted Board evaluated both companies, the original transaction terms, and Progenics’ prospects as an independent company, and then negotiated, approved and is recommending that Progenics stockholders adopt the Amended Merger Agreement. Two of those five new independent directors, Dr. Gérard Ber and Mr. Heinz Mäusli, will serve on the Board of Directors of the combined company upon the closing of the proposed merger.

"We are very pleased that Velan has agreed to support the Progenics merger and our combined company over the next year," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "As an experienced life sciences investor, Velan sees the potential of our combined company to create a platform that leverages Lantheus’ long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics’ three leading FDA approved products, clinical pipeline and development capabilities."

"We have spent time with Mary Anne and the broader Lantheus team and are pleased with their receptivity to stockholder perspectives, operational excellence, financial prudence, and growth orientation," said Bala Venkataraman of Velan. "We trusted the reconstituted Progenics Board to evaluate the combination with Lantheus. The Progenics Board has spoken, and we applaud its ability to evaluate alternatives and ultimately secure a fair transaction that maximizes long-term value for all stockholders. In particular, we are pleased that the revised deal consideration and improved pro forma governance terms are more closely aligned with the value that Progenics brings to Lantheus. We believe that current market prices do not properly recognize the promising future of the combined company, which involves unique assets, significant synergy benefits, and enhanced leadership. We have spoken with fellow stockholders, both of Progenics and Lantheus, and are pleased to see alignment on the value of the combined company under the revised transaction. We believe this combination is in the best interests of both Lantheus’ and Progenics’ stockholders, as well as patients and physicians. We see significant upside potential from this combination over the long term."

Ann MacDougall, Interim Chairman of the Progenics Board said, "We appreciate the constructive spirit in which Lantheus conducted the negotiations of the Amended Merger Agreement as well as Velan’s support for our efforts and for the transaction."

As previously announced, Progenics and Lantheus have scheduled their respective special meetings of stockholders to vote on matters related to the proposed merger to be held on June 16, 2020. Further details about the time, location and record date for the special meetings will be announced when finalized. The proposed merger is expected to close in the second quarter of 2020, subject to approval by Lantheus and Progenics stockholders and satisfaction of other customary closing conditions.