Photocure ASA

Earnings Release • Nov 7, 2019

Photocure ASA: Results for the third quarter of 2019

Photocure ASA: Results for the third quarter of 2019

Oslo, Norway, 7 November 2019: Photocure ASA (OSE:PHO), today reported a revenue

growth of 42% in local currency for the U.S. market in the third quarter of

2019, contributing to Hexvix/Cysview revenues of NOK 51.1 million (Q3 2018: NOK

43.5) and an EBITDA of NOK 8.3 million (NOK -3.1 million). The company entered

into a license agreement with Asieris for the global commercialization of

Cevira® and reiterates the significant revenue growth and profit opportunities

in the U.S. market.

"The third quarter was a busy period for Photocure with continued strong growth

in the important U.S market and an increase in the installed base of blue light

cystoscopes to 211 at the end of the quarter. This development provides a solid

platform for further growth in 2020 and beyond, as we see a large untapped

potential in the U.S.  We will continue to develop the significant commercial

opportunities in the U.S. in order to achieve our ambition to make Cysview the

standard of care for bladder cancer patients," says Daniel Schneider, President

& Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 60.8 million in the third quarter

of 2019 (NOK 44.4 million), with an EBITDA of NOK 8.3 million (NOK -3.1

million). Net result was NOK -0.6 million (NOK -4.8 million), while the cash

position ended at NOK 95.9 million. The sales development in the U.S. was strong

with an accelerated unit sales increase of 34% in the quarter. The revenues in

the Nordics declined 7% to NOK 9.9 million (NOK 10.6 million) in the third

quarter. EBITDA for the Hexvix/Cysview commercial franchise ended at NOK 2.6

million in the third quarter of 2019. At the end of the period, the total

installed base of permanent blue light cystoscopes (BLCs) in was 189 the U.S. In

addition, 22 flexible cystoscopes for the surveillance setting have been

installed, which represents an increase of 8 in the quarter.

Photocure has built considerable experience in the bladder cancer market through

its Hexvix/Cysview franchise and sees significant long-term value creation

potential in this market segment. The company aims to capitalize on a number of

factors including inclusion in the AUA-SUO guidelines, increased patient

awareness and the improved reimbursement of Cysview from 2020. These drivers

will significantly increase penetration in the U.S. market. Furthermore, with

the approval of Cysview to be used with flexible cystoscopes, a significant

market opportunity has opened in the surveillance segment.

Given the large untapped market opportunities, the company has invested in the

U.S. commercial and medical infrastructure. October 1, Geoffrey Coy joined

Photocure as Vice President and General Manager of U.S. operations to strengthen

the growth initiatives further. The company has a 2020 forecasted revenue range

of USD 20-25 million in the U.S., up from USD 7.8 million in 2018, and sees

significant continued revenue growth and profit opportunities in the U.S. market

beyond 2020. The company is fully funded for this strategy.

During the third quarter, Photocure entered into a license agreement providing

Asieris Meditech Co., Ltd (Asieris) with a world-wide license to develop and

commercialize Cevira® for the treatment of HPV induced cervical precancerous

lesions.

Asieris plans to launch a global clinical development program with an initial

focus on the China market based on Photocure's Phase 2b data and the Phase 3

study design elements agreed with the U.S. FDA. The development for the US and

EU markets will follow when clinical data from the China focused Phase 3 study

confirms the safety and efficacy, estimated to be finished in 2022. Asieris will

assume responsibility for the manufacture of the Cevira® product while Photocure

retains responsibility for the manufacture of the active pharmaceutical

ingredient. Under the License Agreement, Photocure will receive a total signing

fee of USD 5 million within 6 months after signing. In addition, the company may

receive a total of USD 18 million based upon achievement of certain clinical and

regulatory milestones in China and up to USD 36 million for certain clinical and

regulatory milestones in USA and EU. Approval of a second indication in China,

the US and the EU would result in payments of up to USD 14 million.

Additionally, sales milestones and royalties of 10% to 20% will apply in all

markets.

"We were proud to announce the agreement with Asieris during the quarter. Aseris

will have the world-wide license to develop and commercialize Cevira for the

treatment of HPV induced cervical precancerous lesions. Under the agreement,

Photocure will receive signing fees, and potentially development and approval

milestones and sales milestones in total up to USD 250 million, in addition to

sales royalties. The Cevira deal is in line with our strategy of divest and

maximize the value of products that do not fit our strategic focus, and to build

the Bladder Cancer Company," Schneider concludes.

Please find the full financial report and presentation enclosed.

Photocure will present its third quarter report on Thursday 7 November 2019 at

Hotel Continental, Oslo, Norway. The presentation will begin at 08:30 (CET) and

representatives from the company will be Daniel Schneider, President & CEO and

Erik Dahl, CFO. The presentation will be held in English.

It will be possible to follow the presentation through

https://webtv.hegnar.no/presentation.php?webcastId=9816440

A light snack will be served from 08:00 (CET). The presentation is scheduled to

conclude at 09:15 (CET).

For further information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Tel: + 1-609 759-6515

Email: ds@photocure.com

Erik Dahl

Chief Financial Officer

Tel: +47 450 55 000

Email: ed@photocure.no

About Photocure ASA

Photocure, The Bladder Cancer Company, delivers transformative solutions to

improve the lives of bladder cancer patients. Our unique technology, which makes

cancer cells glow bright pink, has led to better health outcomes for patients

worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo

Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in

Princeton, New Jersey. For more information, please visit us at

www.photocure.com, www.hexvix.com or www.cysview.com