Photocure ASA: Results for the fourth quarter of 2020

On March 3, 2021 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 97.7 million in the fourth quarter of 2020 (Q4 2019: NOK 58.8). Product revenues increased 20% in FY2020 representing strong execution in an unprecedented year (Press release, PhotoCure, MAR 3, 2021, View Source [SID1234576046]). Due to the ongoing pandemic, the Company suspends guidance for its 2023 revenue ambition in the range of NOK 1 billion. Photocure plans to re-issue financial guidance once the impact from Covid-19 is significantly diminished and physician practices and patient flow have normalized in both the U.S. and Europe.

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"Photocure grew sales in 2020 despite the significant operational challenges during a major global pandemic," says Dan Schneider, President & Chief Executive Officer of Photocure. "Despite the limited access to hospitals and physicians due to Covid-19, we still achieved positive growth in the U.S. Key accomplishments for the year included: continuing to generate growth in Cysview product sales and installations of BLC equipment in the U.S.; successfully integrating the European Hexvix business and launching commercial operations on 1 October; generating value with our partner, Asieris, who is advancing Cevira through Phase III development, and working with our licensing partners to expand Hexvix use worldwide."

Photocure reported total group revenues of NOK 97.9 million in the fourth quarter of 2020 (NOK 115.6 million) with an EBITDA before restructuring of NOK 15.2 million (NOK 54.8 million), and where the corresponding period in 2019 included sign-on fee and milestone payments of NOK 56.5 million. Hexvix/Cysview revenues were NOK 97.7 million (NOK 58.8 million). Growth in the U.S. market continued, despite limited access to hospitals and physicians due to the Covid-19 pandemic, with in-market unit sales up 11%, while European revenues grew 83.8% following a successful launch of the Company’s commercial organization in markets previously operated by Ipsen Pharma SAS.

The installed base of cystoscopes in the U.S. was 268 at the end of the fourth quarter, an increase of 45 units or 20% since the end of 2019. Blue Light Cystoscopy (BLC) in the surveillance setting is a key priority for Photocure in the U.S. market. By the end of the fourth quarter, a total base of 38 flexible cystoscopes have been installed representing a 46% increase over the prior year, giving more patients access to blue light cystoscopy procedures with less constraints in the office-based setting.

"I am pleased with how we managed through these unprecedented times and proud of our employees for adapting to changing working conditions and continuing to serve our patients and customers. Our performance in dealing with the business volatility throughout 2020, including the rebound in the third quarter, gives me confidence in the periods ahead," Schneider adds.

The ongoing Covid-19 pandemic adds continued uncertainty to Photocure’s near-term business forecast, which impacts the reliability of financial estimates. However, the Company believes that the benefits of blue light cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. Procedures are expected to rebound back to pre-Covid-19 growth rates in the U.S. in places where bladder cancer patient care has been disrupted by Covid-19. In the newly acquired European markets, the Company also expects to see significant growth opportunities.

"Given the ongoing pandemic conditions, we have suspended our guidance for 2023 revenues in the range of NOK 1 billion. However, we plan to re-issue financial guidance once the impact of Covid-19 is significantly diminished and physician practices and patient flow have normalized in both the U.S. and Europe. Importantly, we are continuing to execute on our business plan to become a leader in the bladder cancer treatment segment, and we remain well-prepared to return to our prior growth trajectory when the pandemic is resolved," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the fourth quarter 2020 financial report on pages 26-27.

Photocure will present its fourth quarter 2020 report on Wednesday 3 March 2021 at 14:00 CET. The investor presentation will be streamed live and be hosted by Dan Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20210303_1. The presentation is scheduled to conclude at 14:45 CET.

Century Therapeutics Completes $160 Million Series C Financing to Accelerate Development of iPSC-derived Cell Therapy Pipeline

On March 3, 2021 Century Therapeutics, a leading cell therapy company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported the closing of a $160 million Series C financing (Press release, Century Therapeutics, MAR 3, 2021, View Source [SID1234576045]). The financing was led by Casdin Capital and brought together a syndicate of new investors including Fidelity Management & Research LLC, the Federated Hermes Kauffmann Funds, RA Capital, Logos Capital, OrbiMed, Marshall Wace, Qatar Investment Authority, Avidity Partners, and Octagon Capital. Founding investors Versant Ventures and Leaps by Bayer also participated. Eli Casdin, Founder and Chief Investment Officer of Casdin Capital will be joining the Century Therapeutics Board of Directors.

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"We are fortunate to be surrounded by such a top-tier group of investors, whose support will enable the acceleration of Century’s technology platform into the clinic," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "With this new investor partnership, we are well-positioned to capitalize on the tremendous potential of our integrated iPSC, cell engineering and manufacturing capabilities to develop safer, more effective and more affordable next generation allogeneic cancer therapies."

Funds raised will help advance Century’s rich pre-clinical pipeline, which includes multiple iPSC-derived CAR-iT and CAR-iNK cell products. These products are designed to resist host rejection, enhance cell persistence, and allow repeat dosing to provide durable responses in all patients. The team anticipates beginning clinical testing of its first products in 2022, as well as generating multiple INDs annually in the coming years.

"It’s a remarkable and transformative time in the field, with the ability to engineer cells for therapeutic impact now a commercial reality. At the same time, iPSC technology has matured and is now leading the transition from bespoke autologous products to off-the-shelf allogeneic ones." said Eli Casdin CIO of Casdin Capital. "We could not be more excited to partner with the expert team at Century Therapeutics and do our part to help them leverage and accelerate their deep technical expertise in cellular reprogramming, differentiation, genetic engineering and manufacturing to deliver on this next phase of cellular therapy."

Protagonist Therapeutics to Announce Fourth Quarter and Full Year 2020 Financial Results

On March 3, 2021 Protagonist Therapeutics, Inc. (Nasdaq: PTGX), reported it will host a conference call and webcast on Wednesday, March 10 at 4:30 pm ET/1:30 pm PT to discuss its fourth quarter and full year 2020 financial results (Press release, Protagonist, MAR 3, 2021, View Source [SID1234576044]).

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Conference Call and Webcast Information

To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (International) and refer to conference ID #: 7756175. A live webcast of the call will also be accessible on the Investors section of the Company’s website at www.protagonist-inc.com. The replay will be available on the Company’s website approximately two hours after the call.

I-Mab to Report Financial Results for the Full Year 2020 and Provide Corporate Update on March 29, 2021

On March 3, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it will report financial results for the full year ended December 31, 2020 before the market opens on Monday, March 29, 2021, and host a conference call to discuss the results and provide a corporate update at 8:00 a.m. ET (Press release, I-Mab Biopharma, MAR 3, 2021, View Source [SID1234576043]).

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Conference Call and Webcast Information

I-Mab will host a live conference call and webcast on March 29, 2021 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:

Registration Link:

View Source

Conference ID:

4848159

Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.

A webcast replay will be archived on the Company’s website for one year after the conclusion of the call at View Source

A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4848159.

Viracta Therapeutics to Participate at H.C. Wainwright Global Life Sciences Conference

On March 3, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that Viracta will participate at the H.C. Wainwright Global Life Sciences Conference, being held March 9-10, 2021 (Press release, Viracta Therapeutics, MAR 3, 2021, View Source [SID1234576042]). A pre-recorded presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7 a.m. ET on March 9, 2021. Viracta’s management team will also be available for one-on-one investor meetings at the conference.

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