Full year report January-December 2015

IPO and start of global Phase III trials for CAM2038

Fourth quarter 2015

• Net revenue MSEK 36.3 (144.9).
• Operating result before items affecting comparability MSEK -4.9 (96.6).
• Operating result after items affecting comparability MSEK -40.4 (96.6).
• Result after tax MSEK -31.8 (74.9), including items affecting comparability of MSEK 27.7 (0).
• Earnings per share before dilution SEK -1.05 (3.14) and after dilution SEK -1.05 (2.97).
• Cash flow from operations MSEK 39.5 (146.7).
• Cash and cash equivalents MSEK 716.1 (0.0).
• First patient dosed in a pivotal Phase II trial of the opioid blocking effect of CAM2038.
• First patients dosed in two Phase III trials of CAM2038 for treatment of opioid dependence.
• Treatment completed of all patients in Phase II study of CAM2032 for treatment of prostate cancer.
• Richard Jameson appointed as Chief Commercial Officer and Member of Camurus’ Executive Team.
• Camurus’ share listed on Nasdaq Stockholm on 3rd December.

January – December 2015

• Net revenue MSEK 154.8 (208.2).
• Operating result before items affecting comparability MSEK -30.5 (62.3).
• Operating result after items affecting comparability MSEK -204.1 (62.3).
• Result after tax MSEK -159.5 (48.3), including items affecting comparability of MSEK 135.4.
• Earnings per share before dilution SEK -6.33 (2.06) and after dilution SEK -6.33 (1.92).
• Cash flow from operations MSEK -5.7 (69.4).
• Positive results from two clinical Phase I trials of CAM2038 (subcutaneous once-weekly and once-monthly buprenorphine) versus daily sublingual buprenorphine (Subutex®).
• Fast Track granted by FDA for CAM2038 for treatment of opioid dependence.
• First patients included in pivotal Phase II and Phase III registration trials of CAM2038.
• Completion of Phase II trial of CAM2032 for treatment of prostate cancer.
• Two development milestones with total payments of 5 MUSD received from Novartis regarding CAM2029.
• Two new collaboration projects initiated with international pharmaceutical corporations.
• License- and distribution agreement signed with Solasia Pharma regarding episil® in Japan and China.
• Camurus’ share listed on Nasdaq Stockholm.

Significant events after the end of the period

• License agreement signed with Rhythm Inc. for extended release FluidCrystal® setmelanotide for treatment of genetic obesity.

CEO comments on fourth quarter

The fourth quarter was exciting. Important Company highlights was the IPO on Nasdaq Stockholm and the start of two Phase III trials of CAM2038 for treatment of opioid dependence. The recruitment of Richard Jameson as Chief Commercial Officer, with the responsibility to lead our commercial organization in Europe, was another key event.

The development of CAM2038, weekly and monthly subcutaneous buprenorfine injections, for treatment of opioid dependence, and collaboration with our U.S. partner Braeburn Pharmaceuticals, has continued to develop very positively during the fourth quarter. After discussions and alignment with both the European and US healthcare agencies (EMA and FDA) the pivotal clinical program for marketing approval of CAM2038 was initiated with the start of two Phase III and one Phase II trial in opioid dependent patients.

There is a large medical need for new treatment alternatives against opioid dependence that can improve treatment outcomes and on the same time reduce the risks of diversion, abuse, misuse, and accidental pediatric exposure that are associated with current daily products. Opioid addiction has become an epidemic in the U.S., yet it is under-recognized and few medicines are in development for its treatment. A chronic, relapsing disease, opioid addiction can lead to overdose and death. According to the Center for Disease Control and Prevention, opioid-related overdose deaths hit a record high in the U.S. of nearly 29,000 in 2014, corresponding to almost 80 deaths each day. The number of heroin related overdose deaths have quadrupled in only five years. Camurus and Braeburn are firmly committed to reducing the negative impacts of opioid addiction on individuals and society by developing best-in-class long-acting treatment alternatives. We aim to complete the ongoing Phase III efficacy trial in 2016 and submit marketing approvals applications in Europe and U.S. during 2017.

CAM2038 is also being developed for treatment of pain. A first Phase II study in opioid dependent patients with chronic pain is planned to start during the first quarter of 2016.

Together with our partner Novartis, we are in the process of completing a Phase II study of our long-acting octreotide product, CAM2029, in two patient groups with acromegaly and neuroendocrine tumours, respectively. Results are expected during the second quarter 2016. In parallel, manufacturing preparations are ongoing for the planned start of two pivotal Phase III registration trials.

During the fourth quarter, treatment of the last patients were completed in the Phase II trial of our product CAM2032 for advanced prostate cancer. Results are expected during the second quarter of 2016. 

Several other promising drug product candidates are also being assessed in preclinical studies by our capable research and development teams. We are planning to take at least one of these products into clinical development during 2016. In addition, we have a number of very exciting collaboration projects with international pharmaceutical and biotech companies, including the collaboration with the U.S.-based company Rhythm on a long-acting peptide product for treatment of genetic obesity, which resulted in a new license agreement in the start of 2016.

To prepare for the launch of CAM2038, we have begun the process of building a commercial organization with initial focus on the opioid addiction market in Europe. In December, we announced the appointment of Richard Jameson to the position as Chief Commercial Officer with the responsibility for leading this strategic endeavor. Richard has broad experience from different senior commercial roles across a number of specialty pharmaceutical companies and markets. Most recently, he was responsible for leading a commercial organization across Europe, the Middle-East and Africa focused on the opioid dependence field.

Following our successful IPO, we have built a solid platform enabling an effective execution of all parts of our strategy: expanding our product pipeline, advancing new products to the market and preparing the launch of CAM2038 in Europe. We will also continue our significant investments in research, innovation and development of our world-leading technologies.

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   

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 February 2016.