On October 22, 2020 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported its financial results for the third quarter ended September 30, 2020 and provided a business update (Press release, argenx, OCT 22, 2020, View Source [SID1234568796]).

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"It has been an important year for argenx, marked by a number of significant achievements that position us to file our first BLA for efgartigimod as a new treatment for gMG by year-end. We remain focused on both the BLA filing and commercial preparations as we work to bring efgartigimod to patients as soon as possible," said Tim Van Hauwermeiren, CEO of argenx. "We have built an exceptional team, established our global supply chain and connected with physicians, payors and patient advocacy groups – all critical elements for a successful commercial launch."

"We are building a broad FcRn antagonist program by leveraging the potential of efgartigimod across a number of important indications where there is a high unmet need for innovation. Our global Phase 3 ADDRESS trial in pemphigus is on track to start soon and, as we did with the ADAPT trial in MG, we have carefully designed the trial alongside patients and physicians to best address the complex challenges presented by this serious disease. We continue to ground our pipeline expansion strategy in biology, working from the science to address severe autoimmune diseases and advance our ‘argenx 2021’ vision across our emerging franchises," continued Mr. Van Hauwermeiren.

THIRD QUARTER 2020 AND RECENT BUSINESS UPDATE

Preparations underway to support potential approval and launch of FcRn antagonist, efgartigimod, in gMG in U.S., Japan and EU

BLA on track to be filed with the FDA by the end of 2020 with an expected U.S. commercial launch in 2021
Japanese Marketing Authorization Application (J-MAA) expected to be filed with the Pharmaceuticals and Medical Devices Agency (PMDA) in the first half of 2021 with an anticipated Japan commercial launch in 2022
Regulatory filing in the EU to follow filing in Japan
Pre-commercial launch activities underway, including global supply chain creation, and physician, payor and patient advocacy engagement
Presented supportive data from global Phase 3 ADAPT trial of efgartigimod in gMG at recent medical meetings, showing rapid and clinically meaningful responses to efgartigimod and a safety profile comparable to placebo

Results from Phase 3 ADAPT trial presented at Myasthenia Gravis Foundation of America (MGFA) 2020 Virtual Scientific Session and American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2020 Virtual Annual Meeting were consistent with previously announced positive topline results
New data analyses presented on significant magnitude and repeatability of response, clinical benefit in antibody-negative patients and validation of proposed mechanism of action, with notable reductions in total IgG and pathogenic autoantibody levels
Broad efgartigimod development plan progressing with Phase 2 trial of fifth indication expected to start in mid-2021

Within neuromuscular franchise, efgartigimod is being developed for gMG and CIDP
FDA discussions to occur by end of 2020 to inform bridging strategy for SC efgartigimod for the treatment of gMG
Path forward to be communicated after alignment with FDA
Phase 2 ADHERE trial of SC efgartigimod for the treatment of CIDP is ongoing
Decision to expand trial after analysis of first 30 patients now expected in first half of 2021 due to enrollment delays caused by COVID-19
Within hematology franchise, efgartigimod is being developed for primary immune thrombocytopenia (ITP)
Communication with FDA planned to discuss development of SC efgartigimod
Updated plan for registration program to include two trials to run concurrently
ADVANCE trial ongoing in up to 156 patients treated with IV efgartigimod
ADVANCE-SC trial expected to start by end of 2020 in up to 156 patients treated with SC efgartigimod
argenx is advancing development of efgartigimod for pemphigus (vulgaris and foliaceus)
Global Phase 3 ADDRESS trial evaluating SC efgartigimod in up to 150 pemphigus patients to initiate by end of 2020
Trial to evaluate efficacy and safety, including potential to drive fast onset of disease control and complete remission and the ability to taper corticosteroids
Preparations underway to initiate Phase 2 trial in fifth rare disease indication by mid-2021
Indication details, including on biology rationale, Phase 2 trial design and commercial opportunity, to be shared during investor event in first half of 2021
Development of cusatuzumab ongoing as potential treatment for acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (MDS) as part of global collaboration and licensing agreement with Cilag GmbH International, an affiliate of Janssen

Ongoing trials under collaboration include:
Phase 2 CULMINATE trial of cusatuzumab in combination with azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy
Phase 1b ELEVATE trial of cusatuzumab in combination with venetoclax +/- azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy
Phase 1 trial in Japan of cusatuzumab in combination with azacitidine evaluating newly diagnosed, elderly AML patients who are ineligible for intensive chemotherapy
Topline data from CULMINATE trial are anticipated to be reported in early 2021
Initiated Phase 1 healthy volunteer study of IV and SC ARGX-117 targeting complement C2

Data from Phase 1 healthy volunteer study expected in mid-2021
Following analysis of Phase 1 data, argenx plans to launch Phase 2 proof-of-concept trials in severe autoimmune diseases, including multifocal motor neuropathy (MMN)
Single-center Phase 1 trial remains open for enrollment to evaluate ARGX-117 as a potential treatment for acute respiratory distress syndrome (ARDS), a frequent and serious complication associated with COVID-19

Continued investment in Immunology Innovation Program to build pipeline of first-in-class antibodies against immunologic targets

New partnerships announced with Chugai and the Clayton Foundation to expand argenx’s access to innovative antibody engineering technologies and to enhance its capabilities to build future antibody candidates with sweeping and half-life extending characteristics
Collaboration with Halozyme for ENHANZE drug delivery technology expanded to include three additional exclusive targets upon nomination bringing the total to six potential targets
DETAILS OF THE FINANCIAL RESULTS

Cash, cash equivalents and current financial assets totaled €1,804.0 million on September 30, 2020, compared to €1,335.8 million on December 31, 2019. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering, including a U.S. offering and a European private placement, which resulted in the receipt of €730.7 million in net proceeds in June 2020, and net cash flows used in operating activities.

Total operating income decreased by €18.6 million for the nine months ended September 30, 2020 to €42.6 million, compared to €61.2 million for the nine months ended September 30, 2019. The decrease was due to the milestone payments following the first-in-human clinical trial with ABBV-115 under the AbbVie collaboration which was achieved in the nine months ended September 30, 2019. This was partly offset by higher revenue recognition of the transaction price related to the Janssen collaboration and the increase in other income driven by higher payroll tax rebates for employing certain research and development personnel.

Research and development expenses increased by €123.5 million for the nine months ended September 30, 2020 to €246.3 million, compared to €122.8 million for the nine months ended September 30, 2019. The increase in the first nine months of 2020 resulted primarily from higher external research and development expenses, primarily related to the efgartigimod program in various indications, the cusatuzumab program and other clinical and preclinical programs. Furthermore, the personnel expenses increased due to a planned increase in headcount.

Selling, general and administrative expenses totaled €100.4 million for the nine months ended September 30, 2020, compared to €41.7 million for the nine months ended September 30, 2019. The increase resulted primarily from higher personnel expenses and consulting fees related to the preparation of a possible future commercialization of argenx’s lead product candidate efgartigimod.

For the nine months ended September 30, 2020, financial expenses, which primarily relate to interest received and changes in fair value of current financial assets, amounted to €1.7 million, compared to a financial income of €10.8 million for the nine months ended September 30, 2019. Financial expenses corresponded mainly to a decrease in net asset value of current financial assets following the impact of the COVID-19 outbreak on the financial markets.

Exchange losses totaled €55.9 million for the nine months ended September 30, 2020, compared to an exchange gain of €26.9 million for the nine months ended September 30, 2019. The change is mainly attributable to unrealized exchange rate losses on the cash, cash equivalents and current financial asset position in U.S. dollars.

EXPECTED 2021 FINANCIAL CALENDAR:

March 4, 2021: FY 2020 financial results and business update
May 13, 2021: Q1 2021 financial results and business update
July 29, 2021: HY 2021 financial results and business update
October 28, 2021: Q3 2021 financial results and business update
CONFERENCE CALL DETAILS
The third quarter 2020 results and business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.

On October 22, 2020 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2020 and updated full-year 2020 financial guidance (Press release, West Pharmaceutical Services, OCT 22, 2020, View Source [SID1234568795]).

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Third-Quarter 2020 Summary (comparisons to prior-year period)

Net sales of $548.0 million grew 20.1%; organic sales growth was 18.2%.
Reported-diluted EPS of $1.09 increased 45%.
Adjusted-diluted EPS of $1.15 increased 46%.
Company is raising full-year 2020 net sales guidance to a new range of $2.10 billion and $2.11 billion.
Company is raising full-year 2020 adjusted-diluted EPS guidance to a new range of $4.50 and $4.55.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"Third-quarter results were robust across the entire business, led by High-Value Products (HVP) and Biologics. Additionally, we benefited from incremental sales related to the COVID-19 pandemic including components used with treatments and supporting therapies as well as potential vaccines currently in clinical trials," said Eric M. Green, President and Chief Executive Officer. "I am proud of our team members for their relentless passion and sense of urgency to help our customers and the patients we jointly serve. Continued excellence in executing our market-led strategy and our global operations position us well for the remainder of the year and into 2021."

Proprietary Products Segment
Net sales grew by 22.1% to $421.5 million. Organic sales growth was 20.3%, with currency translation increasing sales growth by 180 basis points. HVP components represented over 65% of segment sales and generated double-digit organic sales growth.

Our Biologics market unit had strong double-digit organic sales growth, led by Flurotec, Daikyo and NovaPure film-coated components, as well as Westar and Envision components. Our Generics market unit posted high single-digit organic sales growth, and our Pharma market unit grew organic sales by mid-single digits. Both Generics and Pharma market units were led by sales of film-coated and Westar components.

Contract-Manufactured Products Segment
Net sales grew by 14.0% to $126.6 million. Organic sales growth was 11.7% with currency translation increasing sales growth by 230 basis points. Segment performance was led by strong sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first nine months of 2020)
Operating cash flow was $323.8 million, an increase of 24.2%. Capital expenditures were $116.7 million. Free cash flow (operating cash flow minus capital expenditures) was $207.1 million, an increase of 20.4%.

Full-Year 2020 Financial Guidance
Full-year 2020 net sales guidance is expected to be in a range of $2.10 billion and $2.11 billion, compared to a prior range of $2.035 billion and $2.055 billion.

Organic sales growth is expected to be approximately 14% to 15%, compared to a prior guidance of 12%.
Net sales guidance includes an estimated full-year headwind of $4 million for the full-year 2020 based on current foreign exchange rates, compared to prior guidance of a headwind of $26 million.
Full-year 2020 adjusted-diluted EPS is expected to be in a range of $4.50 and $4.55, compared to a prior range of $4.15 and $4.25.
Full-year adjusted-diluted EPS guidance includes an estimated headwind of approximately $0.02 based on current foreign currency exchange rates, compared to prior guidance of a headwind of $0.07.
The revised guidance includes an $0.18 EPS impact from tax benefits from stock-based compensation in the first nine months of 2020.
For the remainder of the year, our EPS guidance range assumes a tax rate of 24% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first nine months of 2020 would provide a positive adjustment to our full-year EPS guidance.
Third-Quarter 2020 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 7564183.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, October 29, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 7564183.

On October 22, 2020 STORM Therapeutics, the leading biotechnology company focused on the discovery and development of small molecule therapies modulating RNA epigenetics, reported that STC-15, its first-in-class drug candidate targeting METTL3, has been selected for development towards first in human clinical studies (Press release, STORM Therapeutics, OCT 22, 2020, View Source [SID1234568794]). The Company intends to submit an IND application in 2021.

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STC-15 is an orally bioavailable, small molecule METTL3 inhibitor targeting an entirely new mechanism of action (modulation of RNA epigenetics) to treat acute myeloid leukaemia (AML) and other solid and haematological cancers.

Clinical candidate selection demonstrates STORM’s ground-breaking work on targeting RNA modifying enzymes for the development of new anti-cancer therapeutics. STORM has used state-of-the-art drug discovery capabilities, combined with unique analytical technologies specifically developed to target RNA epigenetics, to generate highly potent selective and orally bioavailable, small molecule inhibitors of METTL3 and other RNA modifying enzymes.

Keith Blundy, CEO of STORM Therapeutics, said: "STC-15, a highly potent and selective METTL3 inhibitor, is effective in leukaemia cells refractory to chemotherapy treatment. This patient population will be incorporated into the initial clinical trials aiming to accelerate clinical proof of concept for patients with limited other options in addition to exploring combinations with standard of care.

STORM leads the global field of RNA modulation having demonstrated in vivo proof of concept activity of the first RNA methyltransferase inhibitor in relevant animal models for myeloid and solid tumours. METTL3 is one of two programmes from the STORM platform to show in vivo activity, with others to follow."

STORM showcased the activity of first-in-class METTL3 inhibitors in a range of solid tumours, (building on prior POC data in AML from 2019) at two scientific conferences in July 2020.

On October 22, 2020 Targovax ASA (OSE:TRVX) ("Targovax" or the "Company"), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumor, on 14 October 2020, reported a successfully completed private placement of new shares in the Company (the "Private Placement") (Press release, Targovax, OCT 22, 2020, View Source [SID1234568792]).

The NOK 1,034,482.80 share capital increase pertaining to the Private Placement has now been registered with the Norwegian Register of Business Enterprises. The new share capital of the Company is NOK 8,652,059.20, divided into 86,520,592 shares, each with a par value of NOK 0.10.

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The new shares issued in the Private Placement will be listed on the Oslo Stock Exchange today.

On October 22, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the third quarter of fiscal year 2020 (Press release, Chugai, OCT 22, 2020, View Source [SID1234568791]).

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"As in the second quarter, strong growth in exports and royalty revenue far outpaced the decline in domestic product sales, helping Chugai to maintain high growth in the third quarter. The launch of the first recycling antibody Enspryng in Japan and the United States was a major milestone. In terms of research and development, in-house projects that will come after Enspryng are progressing well as crovalimab and SPYK04 have advanced to new development stages. We will continue pursuing innovation based on our unique strength in science and technology to satisfy unmet medical needs and increase corporate value continuously," said Tatsuro Kosaka, Chugai’s Chairman and CEO.

[Third quarter results for 2020]
Despite domestic sales decreased by about 7% affected by the NHI drug price revisions and the market penetration of generic drugs, Chugai reported a double-digit growth year-on-year in both revenues and operating profit for the third quarter (Core-basis), driven by increases in overseas sales, and royalties and other operating income by approximately 40% and 60%, respectively.

Revenues increased by 13.3%. Among sales, domestic sales decreased by 6.5% since sales of mainstay products in the Oncology, Bone and joint diseases, and Renal diseases areas decreased continuously from the second quarter. This resulted from the NHI drug price revisions in April this year and the market penetration of generic drugs. Domestic sales of Enspryng, a neuromyelitis optica spectrum disorder treatment newly launched in August were ¥300 million. On the other hand, overseas sales increased by 39.3% due to an increase in export of Actemra to Roche, including those for clinical trials for COVID-19 pneumonia, and export of Hemlibra, a treatment for hemophilia A, to Roche at a regular shipment price. Royalties and other operating income increased by 63.3% due to a significant increase in royalties for Hemlibra and its profit-sharing income as well as an increase in other operating income resulting from one-time income.

Cost to sales ratio improved by 2.6 percentage points at 43.1% despite the NHI price revisions mainly due to a larger proportion of in-house products including Hemlibra in the total product mix. Operating expenses increased by 5.7% in total. Marketing and distribution expenses and general and administration expenses decreased due to lower business activities caused by the spread of COVID-19. Research and development expenses recorded a double-digit increase with the projects progressing well. Operating profit increased by 35.5% due to the strong increase in revenues and a better cost to sales ratio.

The Company also made good progress in research and development. As the main progress, Chugai submitted a regulatory application in Japan for the SMN2 splicing modifier risdiplam for the treatment of spinal muscular atrophy in October. Progresses in in-house projects included the start of a phase III clinical trial of an anti-C5 recycling antibody crovalimab in paroxysmal nocturnal hemoglobinuria, and the start of clinical development of a small molecule anticancer agent SPYK04. For nemolizumab, an anti-IL-31 receptor A humanized monoclonal antibody created by Chugai, a regulatory application was filed in Japan for the treatment of atopic dermatitis by Maruho Co., Ltd., the licensee in Japan. As for the line extensions of existing products, anti-PD-L1 humanized monoclonal antibody Tecentriq and anti-VEGF humanized monoclonal antibody Avastin have been approved for hepatocellular carcinoma and anti-HER2 antibody-tuberin polymerization inhibitor conjugate Kadcyla has been approved for postoperative adjuvant therapy of HER2-positive early breast cancer.

[Initiatives for COVID-19 and impact on performance]
Regarding the impact of COVID-19 on performance during the nine months under review, there were no major negative impacts on revenues and profits. However, the pandemic has been affecting the progress of certain business activities as described below.

Product supply system maintained stable by taking measures to prevent infection of employees and business partners. No impacts on the product supply have been seen both in Japan and overseas up to now.
Delay of the introduction of new products and those with additional indications, such as Tecentriq and Hemlibra, in the domestic market due to various reasons including restrained sales activities and decrease in the number of hospitalizations and outpatients.
Continuous increase in export of Hemlibra to Roche.
Significant increase in export of Actemra to Roche, including those for clinical trials for COVID-19 pneumonia.
Some expenses were curbed mainly due to cancellation of overseas travels and restrained sales activities in Japan.
No major impacts on the timing of regulatory filing or approval.
Some delays in the initiation and progress of clinical trials for projects under development. These delays are expected to be resolved in time.
No delays in drug discovery activities for high-priority projects.
Construction for Chugai Life Science Park Yokohama temporarily suspended. All construction resumed with limited impacts on the overall construction schedule.
A domestic phase III clinical trial of Actemra for COVID-19 is currently being conducted, and its impact on performance is unclear at this point.