Nordic Nanovector ASA Results for the Second Quarter and First Half 2022

On August 31, 2022 Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company") reported its results for the second quarter and first half 2022 (Press release, Nordic Nanovector, AUG 31, 2022, View Source [SID1234618845]). A presentation by Nordic Nanovector’s senior management team will be held in-person today in Oslo and webcast live beginning at 8:30am CEST – details below.

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Jan H. Egberts Chairman of Nordic Nanovector, commented: "The decision to discontinue PARADIGME* has been a major disappointment for everyone involved, most particularly patients. Given the difficult financing environment and the Company’s current financial position, the responsible course of action is to conserve our resources while we explore all strategic options that may be available to us. We believe the restructuring we have announced, together with the appointment of Carnegie, a leading financial advisor in the Nordic region, will provide significant support in achieving the best possible outcome for our shareholders. We will provide further updates in a timely fashion as appropriate."

*PARADIGME is a global Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line follicular lymphoma (FL) patients, refractory to RTX/anti-CD20 based treatments.

Q2 2022 Highlights

Comprehensive review of PARADIGME implemented
Following continued slow recruitment into PARADIGME with no additional patients enrolled in May 2022 and only 2 since end February 2022
Independent data evaluation commissioned with data analysis by an independent expert panel
Post-period events

Decision made to discontinue PARADIGME
Betalutin profile does not fully meet objectives set out for the PARADIGME study with only one out of three patients responding to treatment and average duration of response of approximately six months
Profile no longer sufficiently competitive to bring Betalutin to the market in the third line relapsed/refractory FL indication within a timeframe that makes financial and commercial sense for the Company
Board implements a restructuring of the Company with the purpose of reducing costs where necessary
25 employees have been made redundant, corresponding to approx. 70% of the total staff. Leadership team has been slimmed down significantly
The costs to close PARADIGME are expected to be in the range NOK 170-200 million, which indicates a cash position of NOK 90-110 million
Carnegie appointed to explore all strategic options available to the Company
Aim to optimise shareholder value following decision to discontinue PARADIGME and implement a restructuring of the Company
Nordic Nanovector does not intend to make any further public comment regarding the review until it has been completed or the Company determines that disclosure is required or appropriate
Financial Highlights

(Figures in brackets = same period 2021 unless otherwise stated)

Revenues for the second quarter 2022 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the second quarter 2022 were NOK 102.8 million (NOK 103.9 million).
Comprehensive loss for the second quarter 2022 amounted to NOK 91.0 million (loss of NOK 101.8 million).
Cash and cash equivalents amounted to NOK 287.4 million at the end of June 2022, compared to NOK 356.3 million at the end of March 2022, and NOK 450.1 million at the end of June 2021.
Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will be held in-person and webcast live beginning at 8:30am CEST.

Venue: Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: Bjørvika
The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2022 from 7:00am CEST the same day.

Orexo to participate in Pareto Securities´ 13th Annual Healthcare Conference

On August 31, 2022 Orexo AB (Publ.), (STO:ORX) (OTCQX:ORXOY), which develops improved pharmaceuticals and evidence-based digital therapeutics primarily targeting the US market where its commercial organization is located, reported the company will participate in Pareto Securities’ 13th Annual Healthcare Conference, that takes place on September 7-8, 2022, at Sergel Hub, Sveavägen 10 A, Stockholm, Sweden (Press release, Orexo, AUG 31, 2022, View Source [SID1234618844]).

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On September 7th at 2.30 pm CET, Nikolaj Sørensen, President and CEO at Orexo, will give a company presentation. Nikolaj Sørensen and the company’s new CFO Fredrik Järrsten will also be available for 1-1 meetings during the conference.

Jazz Pharmaceuticals to Participate in Upcoming September Investor Conferences

On August 31, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will participate in the following upcoming investor conferences (Press release, Jazz Pharmaceuticals, AUG 31, 2022, View Source [SID1234618843]):

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Citi’s 17th Annual BioPharma Conference on Wednesday, September 7, 2022

The presentation is scheduled for 1:00 p.m. ET / 6:00 p.m. IST.
2022 Wells Fargo Healthcare Conference on Thursday, September 8, 2022

The presentation is scheduled for 11:00 a.m. ET / 4:00 p.m. IST.
Audio webcasts of the presentations will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Replays of the webcasts will be archived on the website for 30 days following the conferences.

Mirati Therapeutics to Participate in Two Upcoming Healthcare Conferences

On August 31, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that ir will participate in two upcoming healthcare conferences (Press release, Mirati, AUG 31, 2022, View Source [SID1234618842]).

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Wednesday, September 14 at 8:35 a.m. ET / 5:35 a.m. PT at the Morgan Stanley Healthcare Conference. Laurie Stelzer, chief financial officer, and Ben Hickey, chief commercial officer, will represent the company in a fireside chat.
Wednesday, September 14 at 2:10 p.m. BST / 9:10 a.m. ET / 6:10 a.m. PT at the Bank of America Global Healthcare Conference. David Meek, chief executive officer, will represent the company in a fireside chat.
Investors and the general public are invited to listen to a live webcast of the sessions through the "Investors and Media" section on Mirati.com. A replay of the webcast will be made available following the event.

Genscript Biotech Reports 2022 Interim Results

On August 31, 2022 GenScript Biotech, the world’s leading biotech company, reported its annual results as of June 30, 2022 (Press release, GenScript, AUG 31, 2022, View Source [SID1234618841]).

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"In the first half of 2022, GenScript Group has delivered satisfactory results across all business segments," said Dr. Patrick Liu, Rotating CEO of GenScript. "Our life science business reported steady growth while focusing on R&D innovation and leveraging superior technology platforms to get into emerging fields. Thanks to excellent market capabilities and track record, ProBio’s macromolecular CDMO and GCT CDMO business maintained strong momentum. In the future, ProBio will focus on medium-sized and large pharma and biotech customers and add value to our service projects. By improving product mix, Bestzyme improved its profitability. Bestzyme will optimize its enzyme product portfolio and industrial-grade manufacturing capability, and capture new opportunities in the synthetic biology field. Legend and its partner Janssen successfully commercialized Carvykti. As Legend moves cilta-cel into earlier line clinical trials, Carvykti will benefit more patients worldwide. 2022 marks the 20th anniversary of GenScript. GenScript has developed a diversified business portfolio over years. GenScript will stay committed to the corporate culture and mission to "make people and nature healthier through biotechnology" and create value for our shareholders and investors."

Results Analysis of the Four Business Segments

As the Group has reallocated back office administrative expenses into each business segment following the establishment of Probio legal entities in the second half of 2021, segment operating profit is not directly comparable to the same period in 2021.

Life-science Services and Products

During the Reporting Period, revenue of life-science services and products amounted to approximately US$176.0 million, representing an increase of 15.8% over the same period in 2021. The gross profit was approximately US$99.8 million during the Reporting Period, representing an increase of 8.8% as compared with approximately US$91.7 million for the same period in 2021. The gross profit margin decreased from 60.3% for the same period in 2021 to 56.7% this Reporting Period. The operating profit of life-science services and products during the Reporting Period was approximately US$26.0 million.

The increase in revenue was mainly attributable to the (i) continued growth in molecular biology, protein and antibody business, (ii) successful commercialisation of innovative platforms such as sgRNA, and partially offset by (iii) the decrease in sales in COVID-19 related products and the negative impact on sales due to pandemics in Shanghai, China. Production efficiency gains contributed positively to gross profit margin while (i) loss from overseas production during the initial capacity ramp-up, (ii) increased freight and duty costs, and (iii) decreased price and volume of COVID-19 related products all had negative impacts on gross profit margin. The operating profit was positively impacted by growth in revenue and gross profit while negatively impacted by (i) increased expenses brought by operation and depreciation of overseas production capacity, and (ii) increment in labor costs brought by research and development.

Biologics Development Services

During the Reporting Period, revenue of biologics development services amounted to approximately US$62.7 million, representing an increase of 99.0% over the same period in 2021. Total backlog for biologics development services reached US$228.0 million as at June 30, 2022. The gross profit was approximately US$16.2 million during the Reporting Period, representing an increase of 62.0% as compared with approximately US$10.0 million for the same period in 2021. Adjusted gross profit was US$23.9 million during the Reporting Period, representing an increase of 125.5% over the same period in 2021. Adjusted gross profit margin expanded from 33.7% for the same period in 2021 to 38.1% this Reporting Period. Adjusted operating profit during the Reporting Period was approximately US$3.2 million.

The growth of revenue was mainly attributable to the (i) significant increase of customer projects from overseas business, (ii) expanded capacity and productivity of pre-clinical and clinical development, and(iii) shorter delivery time for antibody discovery and process development. The adjusted gross profit and adjusted operating profit were positively impacted by higher capacity utilization and production efficiency gains.

Industrial Synthetic Biology Products

During the Reporting Period, revenue of industrial synthetic biology products amounted to approximately US$16.8 million, representing a decrease of 6.7% over the same period in 2021. The gross profit was approximately US$7.2 million, representing an increase of 41.2% as compared with approximately US$5.1 million for the same period in 2021. The gross profit margin increased from 28.3% for the same period in 2021 to 42.9% this Reporting Period. The operating profit of industrial synthetic biology products was approximately US$0.4 million during the Reporting Period, whilst the operating loss was approximately US$0.7 million for the same period in 2021.

The decrease in revenue was mainly due to the (i) active pruning of low or negative profit products, (ii) the feed industry in China downturn which led to reduction of use of feed enzymes, and (iii) the situation in Ukraine and Russia which caused the decrease of orders in Eastern Europe. The increase in both gross profit and operating profit was primarily attribute to the (i) adjustment of product portfolio and enhancement of the promotion of high-margin products, (ii) improvement of production process and workflow, and (iii) profit from the license of patents.

Cell Therapy

During the Reporting Period, revenue of cell therapy amounted to approximately US$57.1 million, representing an increase of 68.4% over the same period in 2021. The gross profit was approximately US$52.1 million during the Reporting Period, representing an increase of 53.7% as compared with approximately US$33.9 million for the same period in 2021. The operating loss of cell therapy was approximately US$180.1 million during the Reporting Period, whilst the operating loss was US$168.9 million for the same period in 2021.

The increase in both revenue and gross profit was primarily attributable to the additional milestones achieved in 2021 and 2022, and thus the further recognition of contract revenue from collaboration with Janssen on developing cilta-cel. The operating loss was primarily attributable to the (i) investment in clinical trials resulting from higher patients enrollment and more pipelines, (ii) cost for commercial preparation activities for the launch of cilta-cel, and (iii) expansion of administrative functions.

Revenue

During the Reporting Period, the Group recorded revenue of approximately US$304.7 million, representing an increase of 32.7% from approximately US$229.6 million for the same period in 2021. This is mainly attributable to (i) the continued increase of non-cell therapy products and services from major strategic customers and new competitive services and products, especially in biologics development services, and (ii) the increase of contract revenue derived from Legend’s collaboration with Janssen with new milestones achieved.

Gross profit

During the Reporting Period, the Group’s gross profit increased by 26.6% to approximately US$175.5 million from approximately US$138.6 million for the same period in 2021. This is mainly attributable to the (i) rapid growth of revenue, and (ii) operational efficiency improvement.

The increase in gross profit was partially offset by (i) increased share-based compensation expenses to production teams, particularly in biologics development services, and (ii) increased shipping cost. Adjusted gross profit increased by 31.4% over the same period in 2021.

Selling and distribution expenses

During the Reporting Period, the Group’s selling and distribution expenses increased by 49.1% to approximately US$86.9 million from approximately US$58.3 million for the same period in 2021. This increase is mainly driven by (i) more investment on talent with recruiting experienced personnel with competitive packages, (ii) increased expenses, primarily attributable to the global expansion of our business, and (iii) increased marketing expenses related to Legend’s collaboration with Janssen. Adjusted selling and distribution expenses increased 45.3% over the same period in 2021.

Administrative expenses

During the Reporting Period, the Group’s administrative expenses increased by 41.4% to approximately US$79.6 million from approximately US$56.3 million for the same period in 2021. This is mainly attributable to (i) more investment on talent with recruiting experienced personnel with competitive package and share-based compensation expenses for all business segments, and (ii) the reinforcement of some key administrative functions to support the Group’s overall business expansion and compliance. Adjusted administrative expenses increased 31.0% over the same period in 2021.

Research and development expenses

During the Reporting Period, the research and development expenses kept stable and increased by 1.3% to approximately US$177.4 million from approximately US$175.1 million for the same period in 2021. This is mainly attributable to (i) the continuous investment in talents with competitive package and share-based compensation expenses, and (ii) continuous investment in new products and services, which will significantly strengthen our competitiveness. Adjusted research and development expenses decreased by 1.4% over the same period in 2021.