Camurus Full year report 2019

”This was a pivotal year for Camurus and we are looking forward to a 2020 with strong growth and a positive news flow”

Business highlights fourth quarter 2019

• Total revenues of SEK 35.0 M (7.8) in Q4 and SEK 105.6 M (49.3) for the full year
• Product sales were SEK 30.3 M (4.8) in Q4 and SEK 72.1 M (11.3) for the full year
• Product sales increased by 55 percent compared to the previous quarter
• Net cash position 31 December MSEK 358.7 (134.4)
• FDA granted Citizen Petition revoking the Orphan Designation for Sublocade™, allowing Brixadi™ to be available on the US market from 1 December 2020
• Distribution agreement signed with NewBridge Pharmaceuticals for Buvidal® in 12 countries in the MENA region
• Announcement of topline DEBUT study results showing superior patient global satisfaction with Buvidal® compared to standard of care with sublingual buprenorphine
• Market authorization application submitted to health authority in New Zealand
• Completion of directed share issue with SEK 300 million in proceeds for market preparations for CAM2038 in chronic pain and performance of Phase 3 study of CAM2029 in NET
• Clinical data for Buvidal presented at Lisbon Addiction, Oct 23-25, Lisbon, Portugal and AAAP (American Academy of Addiction Psychiatry) Dec 5-8, San Diego, California

Financial summary fourth quarter 2019

• Net Revenue MSEK 35.0 (7.8)
  - whereof product sales MSEK 30.3 (5.1)
• Operating result MSEK -88.4 (-103.2)
• Result for the period MSEK -71.9 (-87.1)
• Earnings per share SEK -1.47 (-2.11), before and after dilution
• Cash position MSEK 358.7 (134.4)

Financial summary full year 2019

• Net Revenue MSEK 105.5 (49.3)
  - whereof product sales MSEK 72.1 (11.3)
• Operating result MSEK -360.0 (-287.2)
• Result for the period MSEK -289.9 (-234.7)
• Earnings per share SEK -6.23 (-5.77), before and after dilution
• Cash position MSEK 358.7 (134.4)

Financial outlook 2020

• Net revenues are expected to be in the range of MSEK 290 – 330 (excl possible milestone payments relating to Brixadi™) whereof product sales of MSEK 240 – 280
• Full year OPEX is expected to be in the range of MSEK 570 – 610

CEO comments
The successful launch of Buvidal^® in first wave markets in the EU and Australia continued during the fourth quarter, delivering strong double-digit sales growth. The very positive feedback received from patients was reflected in topline results from the DEBUT clinical study, which demonstrated superior patient reported outcomes with Buvidal compared to buprenorphine standard of care. In the US, the FDA approved a Citizen Petition which enables Brixadi™ to enter the market from 1 December 2020. Finally, we took important steps to advance our pipeline of innovative therapies and raised SEK 300 million for Phase 3 development in neuroendocrine tumors and premarketing activities in chronic pain.

Growing Buvidal sales
During the quarter, we saw a continued robust growth of Buvidal sales in the first wave launch markets in the EU and Australia. Product sales grew by 55% compared to the previous quarter to SEK 30.3 million. Full year product sales were SEK 72.1 million, meeting our 2019 guidance, although at the lower end due to unforeseen external delays in legislation changes and market access processes. Total revenues were SEK 35.0 million for the quarter and SEK 105.6 million for the year.

We are pleased with our first year as a commercial stage pharmaceutical company with an own marketing and sales organization. Buvidal was launched in seven countries and the feedback from patients and healthcare professionals have throughout been very positive, which is an important source of inspiration for all of us working at Camurus. In Finland, our first launch market, Buvidal is already the market leader with a 45% year-end share of buprenorphine patients, and 30% of all medication assisted treatment (MAT) patients. After receiving pricing and reimbursement, similar rapid growth was seen in Norway and Australia, while sales in other markets developed at more modest rates but are gaining momentum access limitations and other momentary hurdles are being addressed. At the end of the year around 4,000 patients were in treatment with Buvidal – a 60% increase compared to the end of the third quarter. In 2020, we anticipate Buvidal sales in the range of SEK 240–280 million.

During the fourth quarter we entered a strategic partnership with NewBridge Pharmaceuticals for the commercialization of Buvidal across 12 countries in the Middle East and North Africa (MENA). NewBridge has a strong presence in the region, with local and regional regulatory and medical expertise, an established marketing and sales organization, and a broad pharmaceuticals portfolio in neurology, immunology, and oncology. We look forward to a rewarding collaboration to make Buvidal available to the many patients living with opioid dependence in MENA.

Superior treatment outcomes in DEBUT study
Positive results from the DEBUT clinical study, assessing treatment with Buvidal versus daily sublingual buprenorphine in 120 Australian patients with opioid dependence, were announced during the fourth quarter. This is to our knowledge the first randomized, controlled trial comparing patient reported outcomes (PROs) between a long-acting buprenorphine injection and standard of care in a head-to-head study. Buvidal met the primary endpoint and demonstrated superior patient satisfaction and significant improvements in treatment burden, quality of life and other secondary endpoints compared to standard of care. This is in agreement with earlier published results from our Phase 3 long-term safety study and the positive anecdotal feedback from patients and physicians using Buvidal in real life clinical settings.

In parallel, the core part of the UNLOCT study, comparing weekly and monthly Buvidal to oral methadone in seven prisons in New South Wales, Australia, was completed. Positive preliminary results were presented at the Lisbon Addiction Conference in October 2019 alongside oral and plenary presentations and workshops about Buvidal in the outpatient setting. During 2020 we will continue our high activity at international conferences and publication of new study data for Buvidal in leading scientific journals.

Final approval and launch of Brixadi
The FDA’s decision on 6 November 2019 to grant Braeburn’s Citizen Petition and revoke the orphan designation for Sublocade™ removed the risk of any further exclusivity barriers and Brixadi is now on track for final NDA approval and launch in December 2020, with the possibility of an early launch of the weekly product. The market potential for Brixadi is very significant: with more than 2 million people diagnosed with opioid use disorder and about 1 million patients in MAT in the US, we estimate the US market potential for Brixadi to be approximately USD 600–1,200 million based on a 5–10% market share of buprenorphine patients.

Market authorization application and phase 3 studies
During the quarter preparations continued for the planned submission of an EU market authorization application in the second or third quarter of 2020 for CAM2038 for the treatment of chronic pain, with an anticipated approval in 2021. CAM2038 has a strong and competitive product profile and meets an important medical need for patients with chronic pain whose current treatment options are often limited to daily medication with strong opioids. We are currently conducting detailed market analysis to optimize product positioning and market access in our key markets. We estimate significant potential for CAM2038 in segments of the pain market, at the same magnitude as Buvidal for the treatment of opioid dependence.

During 2019 we started two global Phase 3 studies of our long-acting octreotide depot, CAM2029, for the treatment of acromegaly. The studies will in total include approximately 140 patients across 60 specialist clinics in the US and Europe and are expected to be fully recruited in 2020 with results in 2021. In parallel to these studies, where the investigational drug is administered as a prefilled syringe, we are developing an autoinjector to further simplify and enhance patient self-administration. A pharmacokinetic bridging study is planned to start during the year. Following the successful directed share issue in December 2019, we are also preparing for the start of the pivotal study program for CAM2029 in neuroendocrine tumors as well as in an additional indication where third-party assessments have confirmed the attractiveness and market potential of the CAM2029 product profile, which addresses significant unmet medical needs.

Early stage pipeline and partnerships
During the fourth quarter we submitted a clinical trial application for a Phase 2a study of our treprostinil weekly depot, CAM2043, in patients with Reynaud's phenomenon; a rare and serious condition characterized by episodes of pallor followed by cyanosis of fingers or toes, which can be very painful and cause digital ulcers and dry necrosis. The clinical trial application was granted in January 2020 and the study is expected to start during the second quarter of 2020. In parallel, a Phase 2 study of CAM2043 for treatment of pulmonary arterial hypertension is being planned.

In the collaboration with Rhythm Pharmaceuticals, a weekly setmelanotide depot, CAM4072, for the treatment of genetic obesity disorders is being developed. A Phase 2 study is currently ongoing with more than 70 patients with obesity recruited to date. Results from the study, which is designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of CAM4072 after 3 months treatment, are expected in 2020. In parallel, manufacturing preparations for the start of the pivotal study program are ongoing.

In our new collaboration with Ra Pharmaceuticals on the development of a long-acting zilucoplan, preparations are ongoing for the start of clinical development during 2020. During the quarter, it was announced that the Belgian pharmaceutical company UCB has bid to acquire Ra. The acquisition is expected to be approved during the first quarter of 2020.

Strong fourth quarter lays the foundation for a successful 2020
Our achievements during the fourth quarter, including strong sales growth for Buvidal, improved access for patients, and preparations for launch in new markets, lay the foundation for a successful 2020. Our strategy for Buvidal focuses on increasing our market share, expanding sales to second and third wave markets, and establishing Buvidal as the evidence-based standard of care for the treatment of opioid dependence. In addition to developments on our own markets, we are looking forward to Brixadi becoming available to US patients as well as Buvidal approvals and launches on new markets in e.g. the MENA region. This quarter we also completed a directed share issue, raising SEK 300 million to secure further investments in our late-stage pipeline projects, including chronic pain and neuroendocrine tumors, as well as prioritized early stage projects. I would like to thank existing and new shareholders for your support during 2019 and our growing number of dedicated co-workers at Camurus. This was a pivotal year for Camurus and we are looking forward to a new year with strong growth and a positive news flow

Fredrik Tiberg
President and CEO

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, 07.00 AM CET on 12 February 2020.