Third quarter 2015
- Net sales SEK 37.2 million (34.0).
- Operating profit/loss before items affecting comparability SEK -7.1 million (-1.9).
- Profit/loss after tax SEK -22.7 million (-1.6), including a charge of SEK 17.2 million (0) for a share-related bonus program.
- Earnings per share before and after dilution SEK -3.61 (-0.27).
- Cash flow from operating activities SEK -24.0 million (-24.4).
- Cash and cash equivalents SEK 112.3 million (0.0).
- A development-related milestone payment of USD 2.5 million has been reached in the collaboration with Novartis regarding CAM2029 for treatment of acromegaly and neuroendocrine tumors.
- CAM2038 has been granted Fast Track designation by the US Food and Drug Administration (FDA) for treatment of opioid dependence.
- The FDA has approved the start of two clinical trials, a Phase III and a Phase II trial, forming the basis of the registration of CAM2038 for treatment of opioid dependence.
- Clinical trial applications for a Phase III trial of CAM2038 for treatment of opioid dependence have been submitted to national agencies in the EU and Australia.
- The Board of Camurus has been strengthened with two new members: Kerstin Valinder Strinnholm and Marianne Dicander Alexandersson.
- Preparation for a possible public listing of Camurus on the Nasdaq Stockholm exchange progresses. Costs relating to this have been charged to operating earnings in the amount of SEK 5.1 million.
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CEO statement on the third quarter
Following a period of intensive planning, preparations and dialogue with the US and European regulatory authorities, we and our partner Braeburn Pharmaceuticals are now ready to start clinical Phase III trials which will form the basis for the registration of CAM2038 (weekly and monthly products). CAM2038 has the potential to transform the treatment of opioid dependence by increasing patient compliance and relieving the burden of having to administer medication daily, while on the same time virtually eliminating the risks of diversion, abuse, misuse, and accidental pediatric exposure associated with current daily medications. Granting fast track to the CAM2038 development program demonstrates the FDA’s recognition of the unmet need in this area, and may also contribute to a shorter development time to market approval.
Recruitment of patients to the Phase II and Phase III trials of CAM2038 for treatment of opioid dependence will begin in the US in the fourth quarter. Meanwhile, an additional Phase III trial of CAM2038 for treatment of opioid dependence is being started in Europe and Australia. We are also working with our partner Braeburn Pharmaceuticals on the preparations of clinical trials of CAM2038 for treatment of chronic pain.
Production preparations are under way with Novartis prior to the forthcoming start of Phase III trials of CAM2029 for treatment of acromegaly and neuroendocrine tumors (NET). Alongside this, a Phase II pilot study in two patient groups; acromegaly and NET, is being concluded. In addition, Camurus and Novartis are conducting a dose escalation Phase I trial of another drug candidate, CAM4071, a long-acting peptide (undisclosed ingredient) based on Camurus’ FluidCrystal®injection depot.
A Phase II trial of CAM2032 for treatment of prostate cancer will also be finalized over the next few months. Top-line results from this trial will be available at the beginning of 2016.
In addition to the activities and progress in the clinical project portfolio, preclinical evaluations of a number of new drug candidates are being completed. These include both in-house development projects and several project collaborations with international biotech and pharmaceutical companies. Camurus aims at taking one of the product candidates into clinical development during 2016.
In anticipation of a future marketing approval of CAM2038 (weekly and monthly products) in Europe, we have also recently initiated a process to develop and strengthen our commercial organization for launching CAM2038 on selected European markets. The product is deemed to have significant market potential for treatment of opioid dependence and has a concentrated and familiar target group of prescribing physicians.
In the third quarter, our net sales amounted to SEK 37.2 million (34.0), with an operating profit/loss before items affecting comparability of SEK -7.1 million (-1.9), of which SEK 5.1 million relates to costs incurred for preparations for a possible public listing of the Company. Profit/loss after tax totaled SEK -22.7 million (-1.6), of which SEK 17.2 million represents the cost of a share based bonus program, issued to the employees and Board members of Camurus
In order to realize our strategy and goals of growing and advancing the clinical portfolio and, in parallel, establishing an effective commercial organization for the marketing and sales of CAM2038 in Europe, and other complimentary products, we are now preparing the company for a public listing on the Nasdaq OMX Stockholm exchange.
We look forward to a successful fourth quarter, with considerable opportunities, including the start of our two Phase III trials for CAM2038 to treat opioid dependence together with our US partner Braeburn Pharmaceuticals.
Chief Executive Officer
Upcoming reporting dates
The year-end report and interim report for the fourth quarter 2015 will be published on 17 February 2016.
The annual report for 2015 will be published during the third week of March 2016.
For further information, please contact:
Fredrik Tiberg, Chief Executive Officer
Tel: +46 46 286 46 92, e-mail: firstname.lastname@example.org.
Camurus is a Swedish pharmaceutical company committed to developing and commercializing innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the proprietary nanoscale FluidCrystal® drug delivery technologies and an extensive R&D expertise. Camurus’ clinical pipeline includes products for treatment of cancer, endocrine diseases, pain and addiction, developed in-house and in collaboration with global and specialty pharmaceutical companies. Camurus is a Sandberg Development group company. For more information, please visit www.camurus.com.