Camurus Interim Report January-September 2019

”In the third quarter, we saw a marked increase in our revenues and the number of patients treated with Buvidal^® for opioid dependence”

Summary third quarter 2019

• Net revenues in the quarter were MSEK 40.2 (19.6) and MSEK 70.6 (41.5) in January-September
• Product sales were MSEK 19.5 (0.3) for the quarter and MSEK 41.8 (6.2) in January-September
• Product sales increased by 75 percent compared to the previous quarter
• Buvidal^® was listed for price and reimbursement in Norway, Australia, Scotland, Wales and Northern Ireland
• The District Court for the District of Columbia ordered the FDA to reconsider “with deliberate speed” Braeburn’s application for final approval of Brixadi™
• All patients completed treatment with Buvidal^® in the DEBUT and UNLOC-T clinical studies in Australia
• The pivotal clinical program for CAM2029 was extended with a Phase 3 long-term safety study
• License agreement was signed with Ra Pharmaceuticals for FluidCrystal^® extended release formulation of zilucoplan

Significant event after the period

• FDA grants Braeburn’s Citizen Petition allowing Brixadi™ for treatment of opioid use disorder to be available in the US in December 2020

Financial summary third quarter 2019

• Net Revenue MSEK 40.2 (19.6)
  - whereof product sales MSEK 19.5 (0.3)
• Operating result MSEK -77.4 (-56.4)
• Result for the period MSEK -62.7 (-43.8)
• Earnings per share SEK -1.31 (-1.06), before and after dilution
• Cash position MSEK 192.3 (216.3)

CEO statement
During the third quarter we markedly increased our revenues and the number of patients in treatment with Buvidal^® in the EU and Australia. In the US, the federal district court for the District of Columbia ordered the FDA to reconsider "with deliberate speed" the application for final approval of Brixadi™. The pivotal program for CAM2029 was extended with a Phase 3 long-term safety study and in parallel an autoinjector development was started to further simplify self-administration. In addition, a license agreement was signed with Ra Pharmaceuticals for a long-acting zilucoplan to treat life-threatening blood and tissue disorders.

Market expansion and growing Buvidal^® sales
In the third quarter, we saw continued growth in sales of Buvidal^® for treatment of opioid dependence in the EU and Australia. Our revenues increased by 105 percent to 40.2 MSEK compared to the corresponding quarter 2018. Product sales increased by 73 percent to 19.5 million SEK compared to the previous quarter, while the total number of patients on Buvidal^® increased from about 1300 to 2500. Progress continued on the initial launch markets in the Nordics, Germany and the UK. In our first to launch market, Finland, we achieved an impressive market share of about 30 percent of buprenorphine treated patients and about 20 percent of all patients receiving medication assisted treatment (MAT). The corresponding patient shares in Germany were three and one percent, respectively, indicating a significant growth potential for Buvidal^®.

We delivered on the planned expansion into new geographies with the recent listings of Buvidal^® for reimbursement in Norway, Australia, Scotland, Wales and Northern Ireland. This was highlighted by the announcement in August by the Minister for Health, Greg Hunt, that the Australian government will invest 40 million dollars to give patients access to Buvidal^®, and an additional product, under a PBS listing.¹ We have already seen good initial patient uptake in Norway and Australia and expect an accelerated growth as the awareness of Buvidal^® continues to increase.

We are well advanced preparing for launches in the next wave markets that include Austria, Italy, Spain and Benelux. Importantly, the feedback from prescribers and patients continues to be very positive across all markets and we therefore look positively on the sales development in the fourth quarter and during 2020.

Positive court decision on US exclusivity
In July, Chief Judge Beryl A. Howell of the US District Court for the District of Columbia granted Braeburn’s motion for summary judgment, vacating the FDA’s decision to deny approval of Brixadi™ Monthly and remanding the case to the agency; ordering the FDA to reconsider “with deliberate speed” the application for final approval of Brixadi™, raising our hopes that Brixadi™ will soon be available to patients with opioid dependence in the US. In parallel, a Citizen Petition was conducted to revoke the orphan drug designation of Sublocade™. We are pleased with FDA’s 7 November decision to grant Braeburn’s Citizen Petition, thereby eliminating the risk of further market exclusivities blocking Brixadi™ from the US market. Braeburn can now focus on preparing for launch in 2020 – paving the way for an effective, individualized, long-acting treatment of opioid use disorder accessible to US patients. In view of the July 22 district court ruling, we are surprised by FDA’s decision to uphold the tentative approval decision to 30 November 2020. However, we do not expect that this will have a significant impact on the market potential over time. Brixadi™ has a competitive product profile and Braeburn will be well prepared for the upcoming launch.

Growing scientific evidence base for Buvidal^®
During the period, all patients completed the treatment phases in the clinical studies, DEBUT and UNLOC-T. DEBUT evaluated randomized treatment with Buvidal^® versus sublingual buprenorphine/ naloxone in 120 outpatients in community treatment. UNLOC-T compared non-randomized treatment of Buvidal^® versus methadone a total of 129 patients in eight minimum to maximum security prisons in New South Wales (NSW) and is sponsored by the NSW Ministry of Health. Based on the study experience, scale up is already initiated in NSW prisons. Results from the studies will be presented at leading conferences in early 2020, but significant interest has already been generated as the study design and background data has presented at scientific meetings and conferences. Overall, the awareness of and interest in Buvidal^® is growing. This is partly due to an increasing visibility through presentations, special symposia and plenary lectures by addiction experts at different international scientific conferences, including Lisbon Addictions.

In parallel with growing the evidence base for Buvidal^® progress, we have continued to advance our development pipeline of innovative medicines for treatment of other severe and chronic diseases.

Preparing for submission in chronic pain
We believe our long-acting buprenorphine depots, CAM2038, also has the potential to address unmet medical needs in the area of chronic pain, by combining an effective, round-the clock, long-acting pain relief with a reduced risk of misuse, illegal diversion and overdosing, During the third quarter, we have been preparing for health authority meetings to discuss the planned regulatory submissions planned in e.g. the EU during the first half of 2020.

Phase 3 program expanded for CAM2029
The pivotal Phase 3 program for our long-acting octreotide depot, CAM2029 for treatment of acromegaly, was during the quarter expanded with a 52-week Phase 3 study to assess the long-term safety of CAM2029 in both new patients and patients transferred over from the randomized 24 week efficacy study. These studies will include in total about 140 patients across about 55 clinics in the US and Europe. We currently expect recruitment to be completed during 2020, while efficacy results are expected in 2021. During quarter, we also completed design and study protocol development for the pivotal registration program of CAM2029 in patients with neuroendocrine tumors, NET, and are continuing to evaluate other potential indication areas. Third party market assessments performed during the quarter indicate a market potential for CAM2029 of up to 1,2 billion dollars per year acromegaly and NET, depending on final product presentation and supporting clinical data.² In parallel with these assessments, we have initiated the development of an autoinjector for CAM2029, as a complement to the existing prefilled syringe presentation.

Growing pipeline with own programs, ongoing partnerships and new license agreements
During the period, we also advanced early stage clinical and preclinical programs. Phase 2 preparations for the treprostinil extended release depot, CAM2043, for treatment of pulmonary arterial hypertension and Reynaud's phenomenon, is well advanced, but study starts has for internal capacity reasons been pushed to next year. In the collaboration with Rhythm, CAM4072 for the treatment of genetic obesity disorders, a Phase 2 study is currently ongoing and is expected to be completed during the first half of 2020. In August, Rhythm announced positive results from a pivotal Phase 3 study of daily dosed setmelanotide in patients with obesity caused by pro-opiomelanocortin (POMC) or leptin receptor (LEPR) deficiency. This was good news also for the weekly setmelanotide formulation, supporting both safety and efficacy.

During the quarter, we also signed a license agreement with Ra Pharmaceuticals for the development of a long-acting zilucoplan depot for treatment of generalized myasthenia gravis, immune-mediated necrotizing myopathy, and other tissue-based complement-mediated disorders. Preparations for start of clinical development during 2020 are ongoing. After the period, it was announced that the Belgian pharmaceutical company UCB has put a bid to acquire Ra Pharmaceuticals for 2.5 billion dollars.

Strong third quarter and positive outlook
During the third quarter, we continued the transformation of Camurus from a R&D focused company to a science lead pharmaceutical company with an own commercial infrastructure in the EU and Australia.

In the three quarters since the first commercial sale, I am proud of our excellent and dedicated teams and their significant achievements in establishing an efficient distribution chain and sales of Buvidal^® across our markets in the EU and the Australia. Pricing and reimbursement has been successfully secured in our first wave markets, supported by a robust and growing scientific evidence base for Buvidal^®. We have also initiated new reimbursement applications and initiated launch activities to make our innovative, long-acting treatments available to patients in the next wave markets. We have made excellent progress in our R&D programs and look forward to a strong and positive news flow during the coming quarters.

Fredrik Tiberg
President and CEO

References
1) Media Release 25 August 2019, https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/pbs-support-for-end-of-life-care-and-opioid-dependency

2) Globe Life Sciences reports 2019; data on file

For more information:
Fredrik Tiberg, President and CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com   

Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com

This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 7.00 AM CET on 8 November 2019.