Interim Report January-June 2019

”Camurus had a productive quarter with significant progress in the commercial business, start of a pivotal Phase 3 study of CAM2029, and a new FluidCrystal® partnership”

Summary second quarter 2019 

•  Net revenues in the quarter were MSEK 11.9 (7.3), whereof product sales MSEK 11.3 (2.9)
•  Half‐year net revenues were MSEK 30.4 (22.3) whereof product sales MSEK 22.3 (5.9)
•  Patients in treatment with Buvidal® increased from approximately 500 to 1,300 patients across 150 clinics
•  Buvidal® launch expanded to Australia and Norway
•  Positive pricing and reimbursement decisions achieved on key markets
•  Phase 3 study of CAM2029 in acromegaly initiated following IND acceptance by the FDA
•  GMP manufacturing of CAM2029 in final prefilled syringe presentation completed
•  Braeburn initiated court proceedings to overturn a 3‐year market exclusivity extending to 30 Nov. 2020 and seek immediate market approval of Brixadi™ (the US trade name for Buvidal®)
•  Fast track (180 days) registration procedure granted for Buvidal® in Israel
•  Clinical data for Buvidal® presented at several international conferences, including ASAM in Orlando, IOTOD in Frankfurt, Albatros in Paris, and CPDD in San Antonio, Texas
•  Positive Phase 3 results from long‐term study of Buvidal® published in the leading journal Addiction

Significant event after the period 

•  License agreement with Ra Pharmaceuticals for weekly zilucoplan FluidCrystal® injection depot

Financial summary second quarter 2019 

•  Net Revenue MSEK 11.9 (7.3)
  - whereof product sales MSEK 11.3 (2.9)
•  Operating result MSEK -109.8 (-81.2)
•  Result for the period MSEK -87.6 (-67.5)
•  Earnings per share SEK -1.83 (-1.81), before and after dilution
•  Cash position MSEK 283.1 (199.1)

CEO statement
During the second quarter we reached several important business goals. The launch of Buvidal® for the treatment of opioid dependence was expanded and pricing and reimbursement approvals were obtained in key markets in the EU and Australia. A pivotal Phase 3 study of CAM2029 octreotide SC depot was initiated after IND acceptance by the FDA. In addition, positive results in a research collaboration with Ra Pharma for a new FluidCrystal® based long‐acting formulation of zilucoplan for the treatment of life threatening blood and tissue disorders resulted in a new license agreement,

signed after the period.

Buvidal® reaching new markets
We have continued our launch efforts in the first wave markets, Finland, Sweden, Denmark, Germany and the UK. The feedback from patients and healthcare professionals continues to be positive and inspiring, with numerous reports of how Buvidal® is transforming lives of individuals and families with opioid dependence. Additionally, our initial estimates suggest that treatment retention rates on Buvidal® are high – similar or better than in the Phase 3 long‐term safety study [1]. The number of patients in treatment with Buvidal® increased during the period from about 500 to 1,300, across more than 150 clinics. In our first market, Finland, Buvidal® already has a market share of more than 20% of buprenorphine treated patients and about 15% of all treated patients. As expected, the initial uptake has not been as fast on all markets, due to extended pricing and reimbursement processes. However, we made excellent progress during the quarter and received four positive reimbursement decisions from national authorities in key markets, including in Australia and Norway. In addition, more than 30 formularies in the UK have agreed to include Buvidal® on their listings, representing about one third of all patients with opioid dependence. Sales in other geographies continue to increase, with a high interest in both community and criminal justice settings. In addition, launch preparations have also progressed in the second and third wave markets. By the end of the year, we expect Buvidal® to be available on at least 10 markets, representing almost 400,000 patients in treatment for opioid dependence.

Approval status in the US and Israel
Early in the quarter, our partner Braeburn filed an action in the United States District Court for the District of Columbia (District Court), seeking to overturn the earlier decision by the US Food and Drug Administration (FDA) awarding a three‐year period of exclusivity to Sublocade™, which blocks approval of Brixadi™ monthly until November 30, 2020. The District Court held a hearing on the proceedings on July 15th, 2019, and a decision is expected later in the third quarter. A positive outcome at the District Court could potentially give patients in the US earlier access to Brixadi™ weekly and monthly depots for treatment of opioid use disorder. In Israel, our partner Medison was granted fast track (180 days) registration procedure for Buvidal® and is now on track for late 2019 approval.

Phase 3 publication in opioid dependence
In May 2019, detailed results from the global Phase 3 longterm safety study were published online in Addiction1, showing long‐term safety, efficacy and high rates of patient satisfaction with Buvidal®. Clinical results with Buvidal® were also presented at multiple international scientific conferences: ASAM in Orlando, Florida, IOTOD in Frankfurt, Germany, Albatros Addiction Congress in Paris, France, and CPDD in San Antonio, Texas. The presentations included new analysis of Phase 3 data in patients using fentanyl, a growing problem around the world, showing improved outcomes with Buvidal® versus daily standard treatment with sublingual buprenorphine/naloxone. Additionally, two clinical studies of Buvidal® in outpatient and criminal justice settings respectively have been progressing according to plan. Initial results from both studies are expected in the fourth quarter.

Preparations for regulatory submission for CAM2038 in chronic pain
In the quarter, we also completed a 52‐week Phase 3 long‐term safety extension study of CAM2038 in patients with chronic pain. Data from the study, including pharmacokinetics, are currently being analyzed and the study report is being compiled. Pre‐submission meetings with regulatory authorities in the EU are planned during the autumn, followed by regulatory submissions in the first half of 2020. Based on the product profile and the positive results obtained in the pivotal Phase 3 study, we believe CAM2038 has a significant potential in the chronic pain area. With effective longacting pain relief and reduced risk of misuse, illegal diversion and overdosing, we believe that CAM2038 could become an effective, convenient and potentially safer treatment alternative for patients in need for strong opioid analgesics, such as morphine, oxycodone and fentanyl.

According to external assessments, one million patients in the seven largest global markets (7MM) are taking high doses of opioid analgesic drugs, morphine equivalent dose above 100 mg/day. About 2.5 million are estimated to be on doses above 50 mg/day.

Phase 3 entry with CAM2029 is a significant milestone for Camurus
Following the IND acceptance for entering Phase 3 with CAM2029 octreotide subcutaneous (SC) depot, Camurus now has two innovative product candidates in Phase 3 development, each addressing significant unmet medical needs and markets with large potential. With its ready‐for‐use design, enabling convenient once‐monthly dosing and enhanced plasma exposure, CAM2029 has an attractive target product profile with best‐in‐class potential on a global somatostatin analogue market currently worth more than $2.6 billion.

The start of the pivotal Phase 3 study of CAM2029 represents an important milestone for Camurus. We will enroll 78 patients in about 50 clinical sites in the US and Europe. The last patient in is expected mid‐2020. In parallel, we will also conduct a Phase 3 long‐term safety study in newly recruited patients and rollover patients from the pivotal study. Both studies are expected to be completed during 2021.

Progress in early pipeline and a new promising partnership with Ra Pharma
Aside from the late stage pipeline progress, we continued advancing our early stage programs, including initiating manufacturing of clinical batches of our CAM2043 weekly treprostinil depot for a planned Phase 2 start in H2 2019. Additionally, formulation optimization was performed for two new long‐acting peptide formulations targeting different endocrine disorders, which we plan to take into clinical development in 2020.

In the collaboration with Rhythm, a Phase 2 study of CAM4072, a weekly setmelanotide depot addressing rare genetic obesity disorders is ongoing, and expected to be completed by the end of the year. In parallel, manufacturing preparations are being conducted for a planned Phase 3 start in 2020.

After the quarter, following a successful feasibility study, we signed a license agreement with Ra Pharmaceuticals for a zilucoplan FluidCrystal® depot for the treatment of complement component 5 mediated disorders, including generalized myasthenia gravis and paroxysmal nocturnal hemoglobinuria. Under the agreement, Camurus will receive an upfront payment of $2 million and is eligible to receive up to $14.5 million in development milestones and other license payments, $55 million in sales milestones and a tiered single‐digit royalty on product sales related to the extended release FluidCrystal® formulation of zilucoplan.

Camurus well positioned for the second half of 2019
Camurus had a productive quarter with significant progress in the commercial business, start of a pivotal Phase 3 study of CAM2029, and a new FluidCrystal® partnership. With several positive pricing and reimbursement decisions and launch expansion to new markets, we have laid the foundation for a significantly increased patient access to Buvidal® in Europe and Australia. We see a significant commercial opportunity and an increasing external interest for CAM2029 in acromegaly, neuroendocrine tumors and other indications. In addition, we have growing pipeline of attractive product candidates in clinical development, addressing unmet needs of patients with severe and chronic disease. Together with an increasing number of products and technology partnerships, we expect a strong news flow and revenue growth in line our earlier guidance.

Fredrik Tiberg
President and CEO

References
1) Frost M, Bailey GL, Lintzeris N. et al, Long‐term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out‐patients with opioid use disorder. Addiction 2019;114(8):1416-1426

For more information:
Fredrik Tiberg, CEO and Head of Research
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 18 July 2019.