Camurus Interim Report January-March 2016

Business highlights first quarter 2016

• Recruitment goals reached in two Phase 3 trials of CAM2038 for opioid dependence treatment.
• Start of Phase 2 study of CAM2038 in patients with chronic pain.
• Completion of Phase 2 study of CAM2029 in two patient groups with acromegaly or neuroendocrine tumors.
• Completion of Phase 1 study of CAM4071 in healthy volunteers.
• Clinical development supporting toxicology studies initiated for two new product candidates after completed formulation development and assessment
• License agreement signed with Rhythm Inc. for long-acting FluidCrystal® setmelanotide under development for rare genetic obesity disorders.

Significant events after the reporting period

• Positive results from a Phase 2 study of the blockade of opioid effects by CAM2038 in patients with opioid dependence.

Financial summary first quarter 2016

• Revenues MSEK 20.2 (58.6).
• Operating result MSEK -24.9 (13.1).
• Result after tax MSEK -19.4 (10.2).
• Earnings per share SEK -0.52 (0.41).
• Cash position MSEK 571.9 (116.4).

CEO comments
We have had strong start of the year with positive preclinical assessments of new promising drug candidates, initiation of the build-up of our commercial organization in Europe, and completed recruitment of more than 600 patients in two ongoing Phase 3 trials of our long-acting buprenorphine products for treatment of opioid dependence.

The development of CAM2038 is well-timed, as problems associated with opioid dependence continue to mount. In the US, opioid dependence has reached epidemic proportions. Its’ devastating consequences are getting high attention with daily news headlines and commentaries by leading politicians. The situation is serious and untenable from both humanitarian and socioeconomic perspectives. There is consensus about the need to reduce the stigma of opioid addiction and recognize this condition as a chronic disease that must be treated using evidence based approaches.

Our success in enrolling more than 600 patients in two Phase 3 trials in the US, Europe and Australia in just three months, speaks to the high unmet need in this underserved patient population. With this positive progress, we are looking forward to completing the ongoing trials and receiving Phase 3 efficacy results in Q4 2016. In this context, the recently announced positive results from our Phase 2 opioid challenge study and the continued successful collaboration with Braeburn Pharmaceuticals is noteworthy.

Besides opioid dependence, CAM2038 is also being developed for the treatment of chronic pain. During Q1, we initiated a Phase 2 study in patients with chronic pain, set to deliver results in Q4 2016. We are enthusiastic about the prospects of CAM2038 for treatment of chronic pain, with the potential for round-the-clock pain relief combined with minimal risks of misuse, abuse and diversion.

In our partnership with Novartis, we recently completed a Phase 2 trial of our long-acting octreotide product, CAM2029, in patients with acromegaly and neuroendocrine tumors. Results are expected late Q2 2016. The partnership with Novartis continues to develop well, with high activity in preparing the start of Phase 3 trials.

In the late stage pipeline, we have also recently completed a Phase 2 study of product candidate CAM2032 for treatment of prostate cancer. Top-line results from this trial are expected during the Q2 2016.

We are also progressing with promising new product developments and bridging toxicology studies with two promising candidates were recently initiated. Clinical development of a first prioritized product candidate is planned to start during Q4 2016.

Several collaborations projects are also ongoing with international pharmaceutical and biotech companies. As an example, a new license agreement was signed with the US biotech Rhythm Inc. in January for the development and commercialization of a once-weekly formulation of setmelanotide for treatment of genetic obesity disorders. Shortly after the agreement, Rhythm received a Breakthrough Therapy designation for setmelanotide by US FDA.

We are in a strong growth phase and on track to deliver on all key objectives for this year:

1. Carry through the clinical registration program for CAM2038 for treatment of opioid dependence.
2. Initiate the build-up of our European commercial organization for the marketing of CAM2038.
3. Continue the pivotal clinical program for CAM2038 in the second indication, chronic pain.
4. Complete the preparations of Phase 3 trials of CAM2029.
5. Expand our pipeline with a new drug candidate in clinical development.

I look forward to an exciting and productive first year as a publicly listed company, creating significant value growth through our business operations and in our development pipeline.

Fredrik Tiberg
President and CEO

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

Rein Piir, VP Investor Relations
Tel. +46 (0)70 853 72 92
ir@camurus.com

The information in this press release is disclosed by Camurus AB in accordance with the Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The information was submitted for publication at 07.00 a.m. on 17 May 2016.