Annual Report • Feb 16, 2017
Annual Report
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| Annual Report 2016 | 30 March 2017 |
|---|---|
| Q1 2017 | 3 May 2017, at 13.00 |
| Annual General Meeting | 3 May 2017 |
| O 2 2017 | 13 July 2017 |
| O 3 2017 | 26 October 2017 |
| Full Year Report 2017 | 15 February 2018 |
| Annual Report 2017 | 22 March 2018 |
"Results from our Phase 3 study of CAM2038 in opioid dependence demonstrated significantly better treatment effect with our long-acting depots versus standard of care with daily sublingual tablets."
Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company's share is listed on Nasdag Stockholm under the ticker "CAMX".
The final quarter of 2016 saw us achieve a major milestone for Camurus. Results from our completed Phase 3 study of CAM2038 in opioid dependence demonstrated significantly better treatment effect with our long-acting depots versus standard of care with daily sublingual tablets. With this achievement, we now initiated the work on the market approval applications for both the EMA and FDA.
Our long-acting buprenorphine depots, CAM2038, for treatment of opioid dependence, clearly fulfilled efficacy primary endpoints agreed with the European Medicines Agency (EMA) as well as US Food and Drug Administration (FDA). Additionally, secondary analyses demonstrated superior efficacy versus daily sublingual buprenorphine/naloxone tablets. These clear-cut, positive Phase 3 results are particularly impressive in the light of the randomized, controlled double blind, double dummy design, and with regard to the complex patient population that was included directly from the active opioid misuse. Approximately 70% of the 428 study participants were using heroin and more than half of them were injection opioid users. Most of them also used other illicit drugs, including cocaine, amphetamine and marijuana This group is representative of patients starting their treatment of opioid dependency both in EU and the US.
Present daily treatment with buprenorphine or methadone has been clearly demonstrated to be effective in decreasing opioid misuse, reducing mortality and the spreading of infectious diseases. Unfortunately, these treatments have some significant limitations. These include poor treatment adherence, costs and stigma in connection to need of frequent clinic visits and supervised dosing, overdosing, as well as diversion and misuse.
Using long-acting medications, these limitations can be significantly reduced, or even eliminated, as pointed out by Prof. Edward Nunes MD, PhD, Columbia University Medical School during his presentation at Camurus' first Capital Markets and R&D Day in Stockholm, December 14, 2016. Combined with the documented treatment efficacy and favorable safety profile, our long-acting depot products have the potential to transform the treatment of opioid dependence and provide improvement to patients, healthcare providers and society. Process of filing market authorization and new drug applications for CAM2038 to the EMA and FDA mid 2017 are on track.
During the period, important advances were also made regarding commercial manufacturing as well as establishment of our commercial organization and operational structure in front of the planned launching of CAM2038 in Europe during 2018. We have been working closely with experts and stakeholders within the various national health systems, as well as performing health economic analyses and modelling. Initial results will be presented at the AMCP Managed Care Specialty Pharmacy Annual Meeting i Denver, Colorado in March 2017.
In our collaboration with Novartis, following the announcement of positive Phase 2 results for our subcutaneous long-acting octreotide depot. CAM2029, for treatment of acromegaly and neuroendocrine tumours (NET), a clinical study report has been completed during the quarter. Results will be presented at several conferences during the spring, including ENETS, Barcelona in March and at ENDO, Orlando in April. After completed preparations for GMP-manufacturing of the product during the quarter, GMP manufacturing is now initiated ahead of planned Phase 3 start later in the year.
In the collaboration with Rhythm regarding weekly setmelanotide FluidCrystal® investigational product for treatment of genetic obesity disease, GMP-manufacturing was successfully completed and preparations of a clinical trial are ongoing ahead of the start during 2017.
In our early development pipeline, we initiated a clinical pharmacokinetic study of new product candidates for treatment of pain as well as nausea and vomiting. Two of the programs are
conducted with our US partner Braeburn Pharmaceuticals, after having expanded our license agreement during the period.
A new exciting program in our pipeline is a subcutaneous depot of treprostinil, CAM2043, for treatment of pulmonary arterial hypertension. PAH is a rare progressive lung and heart disease with a poor life expectancy of less than 3 years, if left untreated. Based on our preclinical results, we believe that CAM2043 has potential to significantly improve treatment versus available treatments. Presently treprostinil is administrated using continuous infusion, a complex procedure associated with significant and treatment limiting side-effects such as pain and serious infections. The PAH market exceeded USD 4 billion 2015. with treprostinil representing about 25%.
Our strong results delivered during the past year have resulted in an increased interest in Camurus and contributed to a positive development of the company value. Behind the success is our team of fantastic coworkers, dedicated partners and clinical investigators, as well as their study teams. Warm thanks to you all!
Fredrik Tiberg, President and CEO
Camurus is a research-based pharmaceutical company with a focus on the development and commercialization of new and innovative pharmaceuticals for serious and chronic conditions. where there are clear medical needs and the potential to significantly improve treatment. For the development of new drug candidates Camurus utilizes its own proprietary formulation technology, for example, the long-acting injection depot FluidCrystal®. New proprietary medicines with improved properties and treatment outcomes are developed by combining the company's patented drug delivery technologies with active ingredients with documented safety and efficacy profiles. These are developed with significantly lower cost and risk, compared with the development of completely new pharmaceuticals. Camurus' development pipeline contains product candidates for treatment of cancer and the side effects of cancer treatment. endocrine diseases, pain and addiction, see figure. A summary and status update on the different projects is given below.
NFT-Neuroendocrine tumors CINV - Chemotherapy induced nausea PONV-Postoperative nausea and vomiting
CAM2038 includes subcutaneous weekly and monthly depots of buprenorphine, being developed by Camurus and our partner Braeburn Pharmaceuticals for treatment of opioid dependence. The products, granted FastTrack status by US FDA, are developed to address a serious condition and several shortcomings of currently available medications for daily medication, including limited treatment compliance, misuse, abuse, diversion of current daily medications, and frequent relapses to misuse. To date, the CAM2038 products have been evaluated in four Phase 1/2 clinical trials and one Phase 3 efficacy trial. In all these trials. CAM2038 has demonstrated good safety as well as targeted pharmacological and pharmacodynamic profiles suitable for weekly and monthly dosing. Two additional studies, a Phase 2 and a Phase 3 trial, are currently being completed.
In November, we announced positive results from a pivotal, randomized, double-blind, double-dummy, active-controlled, 24 weeks, efficacy Phase 3 trial of CAM2038. In the trial treatment effect of CAM2038 was compared with daily sublingual buprenorphine/naloxone (SL BPN/NX) which is the current Standard of Care. The results demonstrated that CAM2038 met both primary and secondary endpoints in terms of non-inferior respectively superior efficacy of CAM2038 versus SL BPN/NX. In parallel, the long-term safety Phase 3 trial of CAM2038 is being completed and will be reported by second quarter 2017. During May, we announced positive results from a pivotal Phase 2 trial of opioid blocking efficacy of CAM2038. The results show that CAM2038 treatment effectively blocks subjective opioid effects of injected hydromorphone, which means that CAM2038 can potentially protect patients from relapse to abuse of heroin and prescription opioids. Furthermore, a Phase 2 study evaluating pharmacokinetics of CAM2038 during repeated dosing is ongoing (see chronic pain section). These studies are part of the registration program, which has been agreed with both FDA and FMA
CAM2038 weekly and monthly depots are also being developed for treatment of chronic pain. These products are aimed for providing round-the-clock pain relief, while decreasing the risks of respiratory depression and fatal overdoses associated with full u-opioid agonists, such as morphine, oxycodone and fentanyl. The properties of CAM2038 are considered to conform to the targeted properties and to the quidelines and recommendations for treatments of chronic pain, i.e. the combination of long lasting efficacious analgesia with a reduced risk of misuse, abuse and illicit diversion.
During the quarter, two patient cohorts were completed in the Phase 2 trial of CAM2038 assessing pharmacokinetics, analgesia and safety profiles of repeat doses of weekly and monthly CAM2038. During this period, additional cohort, dosed with 160 mg monthly CAM2038, was included. Results are expected in the second quarter 2017. In parallel, a Phase 3 pivotal trial of CAM2038 assessing efficacy in patients with moderate to severe chronic lower back pain is ongoing.
CAM2029 is a subcutaneous monthly depot of octreotide under development for the treatment of patients with acromegaly or NET. CAM2029 is being developed by Novartis and Camurus as an alternative to the current market leading product Sandostatin® LAR®, with global sales of USD 1.63 billion in 2015. CAM2029 is administered as a simple subcutaneous injection with pre-filled syringe, whereas Sandostatin® LAR® has to be prepared from a powder in a process consisting of six steps before being injected intramuscularly by a healthcare professional. CAM2029 has in clinical trials demonstrated about a 500 percent higher bioavailability of octreotide compared with Sandostatin® LAR®, which gives potential for improved treatment effects in patients who do not respond satisfactorily to current treatments
The completed Phase 2 trial of CAM2029 demonstrated longacting octreotide release with well-maintained control of symptoms and disease biomarkers after switching from Sandostatin® LAR®. The efficacy was based on evaluation of the control of symptoms in NET patients and plasma levels of insulin arowth factor-1 and growth hormone in acromegaly patients. The results will be presented in March at European Neuroendocrine Tumor Society 2017 in Barcelona, Spain, and in April at the Endocrine Society Annual Meeting, ENDO 2017, Orlando, Florida. Full publication is being compiled. In parallel, Novartis, in collaboration with Camurus, is completing the preparations of Phase 3 trials of CAM2029, planned to start 2017.
CAM2032 is a subcutaneous depot product that is being developed by Camurus for treatment of prostate cancer. Other potential indications include precocious puberty (pubertas proecox), gender identity disorders, and endometriosis. The product is based on the active ingredient leuprolide, belonging to the class of gonadotropin releasing hormone analogs. CAM2032 is, being developed as the first product in its class, for easy subcutaneous injection by patients themselves, in the form of a small volume injection with a duration of one month.
Discussions with potential partners for further clinical development are ongoing.
CAM4071 is a product candidate in clinical development under the option, collaboration and licensing agreement with Novartis. The product is a long-acting formulation of an undisclosed peptide based on the FluidCrystal® Injection depot.
A Phase 1 trial of pharmacokinetics and pharmacodynamics. performed together with Novartis, has been completed and is being reported.
Several new product candidates, selected using initial market research, are being evaluated in pharmaceutical and preclinical studies. The development includes formulation optimization with respect to release performance, stability and pharmacological, as well as toxicological and safety related properties in relation to defined target product profiles.
During the period, a Phase 1 clinical trial of three investigational drug products, CAM2047, CAM2048, and CAM2058 was initiated. These drug candidates are based on Camurus' FluidCrystal® injection depot and are being developed for treatment of chemotherapy induced nausea and vomiting (CAM2047), pain (CAM2048) and combined treatment of postoperative pain, nausea and vomiting (CAM2058). Results from the clinical study are expected during the second quarter 2017. During the period, we completed a preclinical evaluation of a new long-acting subcutaneous treprostinil depot, CAM2043, for treatment of pulmonary arterial hypertension. Data from the preclinical program show promising plasma exposure with treprostinil, comparable with those reported in infusion studies, and no significant reactions at the injection site. In parallel, a potential clinical development program is being evaluated for a possible start during the second half-year of 2017.
Camurus is also involved in several collaboration projects with international pharmaceutical companies, where new product candidates are based on Camurus' formulation technology and the partner company's patented active ingredient. These projects involve formulation development and optimization as well as assessments of various pharmacological properties with regard to pre-specified product and market related objectives. The time frame of these initial product evaluations (feasibility studies) is approximately 6-12 months. After positive results, product development can continue under a license agreement. with opportunities for future development and commercial milestone payments as well as royalty on future sales.
Several project collaborations are presently ongoing with international pharmaceutical and biotech companies, with a focus on cancer, obesity, diabetes and HIV. In January 2016, a license agreement was signed with the Boston-based biotech company Rhythm, regarding the use of Camurus' FluidCrystal® injection depot for setmelanotide (RM-493), a novel melanocortin-4 receptor-agonist for treatment of genetic obesity. GMP-manufacturing of clinical supply was completed during the quarter ahead of start of a clinical trial in 2017.
episil® is a medical device for treatment of inflammatory and painful conditions in the oral cavity. The product provides fast pain relief and protection of sore and inflamed mucosal surfaces. as well as severe inflammation caused by e.g. oral mucositis, a common and serious side effect of cancer treatment. In contact with the buccal membrane, episil transforms into a thin protective layer of gel, offering effective pain relief for up to 8 hours.
In December, Camurus' partner Solasia Pharma signed an agreement with Meiji Seika Pharma for commercialisation of episil® in Japan. Market registration processes are ongoing in Japan and China. During the period, episil® was granted marketing approval in Taiwan. In the US, Camurus partner, R-Pharm continues launching of episil®, with initial focus on breast cancer patients.
Revenues during the fourth quarter amounted to MSEK 37.1 (36.3), generated from license agreements, project activities and product sales.
Marketing, business development and distribution costs during the fourth quarter, were MSEK 9.4 (7.0).
Administrative expenses amounted to MSEK 4.1 (+6.8). The difference compared to the same period last year is mainly related to a retroactive reallocation between administrative expenses, marketing and distribution costs and research and development (R&D) costs.
R&D costs were MSEK 59.0 (41.1), including depreciation and amortization of tangible and intangible assets.
Other operating incomes/expenses mainly consist of currency exchange gains in operational activities of a total of MSFK 1.4 (0.3).
The operating result for the fourth quarter, before and after items affecting comparability was MSEK-35.1 (-4.9) and MSEK-35.1 (-40.4).
Financial items for the period was MSFK-0.0 (-0.1).
Tax for the quarter was MSEK 7.4 (8.7) and is mainly attributable to deferred tax for losses during the quarter.
The result for the period was MSEK-27.8 (-31.9), corresponding
to earnings per share of SEK-0.75 (-1.05) before and after dilution.
Cash flow from operating activities, before change in working capital, was negative and amounted to MSEK-34.3 (-37.1).
Change in working capital was affected the cash flow positively by MSEK 26.7 (76.7).
Cash flow from investing activities was MSEK-2.7 (-0.5), and from finance activities MSEK 0.7 (564.7) related to issuance of subscription warrants.
The Company's cash position as of 31:st of December 2016 was MSEK 508.6 (716.1). The change compared to previous year relates mainly to the operating result and the change in working capital related to social security and withholding tax of MSEK 86.6 paid in January 2016, for the participants in the company's share bonus program that was executed in connection to the listing in December 2015.
There were no outstanding loans as of December 31, 2016, and no loans have been taken up since.
Consolidated equity as of December 31, 2016, was MSFK 564.4 (640.6).
As a part of the establishment of the European commercial organization, a shelf company has been acquired in Germany during the fourth quarter and after the period a company has been set up in UK. Both companies are wholly owned subsidiaries to Camurus AB.
Camurus' share is listed on Nasdag Stockholm since the December 3, 2015. At the end of the period, the total number of shares in the company was 37,281,486 (37,281,486).
In accordance with a decision by a Shareholder's General Meeting in May 2016, an incentive program (TO2016 / 2019) under which a maximum of 550,000 warrants can be issued, was introduced. The dilution of a full utilization of the program corresponds to 1.5% of the share capital and voting rights. The number of warrants that have been issued are 550,000 and which give the right to subscribe for an equal number of shares during the period May 15, 2019 - December 15, 2019. As per December 31, 2016, 404, 300 warrants had been subscribed for with. During the quarter equity increased with MSEK 0,7 and earnings were negatively impacted by MSEK 0.7, after tax, related to the stay-on bonus in the program.
Revenues for the quarter amounted to MSEK 37.1 (36.3) and the result after tax was MSEK-28.4 (-19.7).
On December 31, 2016, equity in the Parent Company amounted to MSEK 547.1 (622.6).
Total assets at the end of the period was MSEK 626.5 (801.2) of which MSEK 508.4 (716.1) were cash and cash equivalents.
At the end of the period, Camurus had 62 (48) employees, of whom 44 (35) were within research and development. The full time equivalent employees (FTEs) during the quarter was 56 (48).
The company management makes estimates and assumptions about the future. Such estimates can deviate considerably from the actual outcome, since they are based on various assumptions and experiences.
The estimates and assumptions that may lead to the risk of significant adjustments to reported amounts for assets and liabilities relate mainly to measurement and allocation of revenues and costs in connection with licensing agreements and deferred tax receivables
Risks in ongoing development projects comprise technical and manufacturing related risks (including products failing to meet set specifications post manufacturing), safety and effectrelated risks that can arise in clinical trials, regulatory risks relating to non-approval or delays of clinical trial applications and market approvals, and commercial risks relating to the sale of proprietary and competing products and their development on the market. as well as IP risks relating to approval of patent applications and
patent protection. In addition, there are risks relating to the development, strategy and management decisions of Camurus' partners.
Camurus pursues operations and its business on the international market and the Company is therefore exposed to currency risks, since revenues and costs arise in different currencies, mainly SEK, EUR and USD.
The Board of Directors has not changed its outlook on future developments in relation to their outlook published in the interim report for the third quarter 2016.
Camurus Annual General Meeting 2017 will be held on Wednesday 3 May, at 17.00 CET, at Elite Hotel Ideon, Scheelevägen 27, Ideon Science Park, 223 63 Lund.
In accordance with the dividend policy adopted by the Board, no dividend is proposed for the financial year 2016.
The Annual Report for 2016 will be published on www.camurus.com on March 30, 2017. It will also be available from Camurus AB's headquarters in Lund
This report has not been reviewed by the company's auditors.
For further information, please contact: Fredrik Tiberg, Chief Executive Officer Rein Piir, VP Investor Relations Tel.: +46 46 286 46 92, e-mail: [email protected].
Lund, February 15, 2017 Camurus AB Board of Directors
| KSEK | Note | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Net sales | 3 | 37,126 | 36,340 | 113,737 | 154,799 |
| Cost of goods sold | $-1,229$ | $-105$ | $-2,140$ | $-237$ | |
| Gross profit | 35,587 | 36,235 | 111,597 | 154,562 | |
| 0 | |||||
| Marketing and distribution costs | $-9,385$ | $-6,986$ | $-24,738$ | $-19,411$ | |
| Administrative expenses | $-4,067$ | 6,778 | $-17,985$ | $-11,934$ | |
| Research and development costs | $-59,017$ | $-41,140$ | $-172,077$ | $-153,080$ | |
| Other operating income | 1,436 | 262 | 751 | 57 | |
| Other operating expenses | $-658$ | ||||
| Operating result before items affecting comparability | 7 | $-35,136$ | -4,850 | $-102,452$ | $-30,464$ |
| Items affecting comparability attributable to public listing costs | 7 | $-33,970$ | $-33,970$ | ||
| Items affecting comparability attributable to Share bonus program | $-1,596$ | $-139,671$ | |||
| Operating result | 6 | $-35,136$ | $-40,415$ | $-102,452$ | $-204,104$ |
| Finance income | 87 | 95 | 2 | ||
| Finance expenses | $-128$ | $-145$ | $-1,002$ | $-166$ | |
| Net financial items | $-41$ | $-144$ | $-907$ | $-164$ | |
| 0 | |||||
| Result before tax | $-35,178$ | $-40,560$ | $-103,359$ | $-204,268$ | |
| 0 | |||||
| Income tax | 9 | 7,367 | 8,711 | 22,367 | 44,727 |
| Result for the period | $-27,811$ | $-31,850$ | $-80,993$ | $-159,542$ |
Total comprehensive income is the same as the result for the period, as the consolidated group contains no items that are recognized under other comprehensive income. Total comprehensive income is attributable to parent company shareholders
| SEK | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|
| Earnings per share before dilution, SEK | $-0.75$ | $-1.05$ | $-2.17$ | $-6.02$ |
| Earnings per share after dilution, SEK | $-0.75$ | $-1.05$ | $-2.17$ | $-6.02$ |
Presently, the company has one subscription warrant program active. For further information see page 8, Camurus' share.
Since 2013, Camurus had a long-term share based incentive program in place, aimed at employees and Board members and in connection with the listing of the company's share on 3 December 2015 the programme was completed. The impact on previous year's results amounted MSEK 108.9 after tax, with a corresponding increase in equity of MSEK 108.8 and a social security fee liability of MSEK 30.8. For further information please see Note 7. Earnings per share 2015 was effected by -4.32 SEK per share before and after dilution.
| KSEK | Note | 31-12-2016 | 31-12-2015 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible assets Capitalized development expenditure |
18,741 | 20,823 | |
| Tangible assets | |||
| Equipment | 9,759 | 6,634 | |
| Financial assets | |||
| Long-term receivables Group companies | 0 | 0 | |
| Deferred tax receivables | 9 | 61,685 | 39,317 |
| Total fixed assets | 90,185 | 66,775 | |
| Current assets | |||
| Inventories | |||
| Finished goods and goods for resale | 12,380 | 3,241 | |
| Current receivables | |||
| Receivables from Group companies | 0 | 207 | |
| Trade receivables | 8,304 | 8,917 | |
| Other receivables | 3,855 | 5,500 | |
| Prepayments and accrued income | 16,459 | 15,613 | |
| Total current receivables | 5 | 28,618 | 30,237 |
| Cash and cash equivalents | 508,594 | 716,096 | |
| Total current assets | 549,592 | 749,574 | |
| TOTAL ASSETS | 639,776 | 816,349 |
| KSEK | Note | 31-12-2016 | 31-12-2015 |
|---|---|---|---|
| EQUITY | |||
| Equity attributable to parent company shareholder |
|||
| Share capital | 932 | 932 | |
| Other contributed capital | 631,034 | 626,181 | |
| Retained earnings, including result for the period |
$-67,549$ | 13,444 | |
| Total equity | 4,10 | 564,418 | 640,557 |
| LIABILITIES | |||
| Long-term liabilities | |||
| Deferred tax liability | |||
| Total long-term liabilities | |||
| Short-term liabilities | |||
| Liabilities to Group companies | $\Omega$ | $\Omega$ | |
| Trade payables | 17,560 | 31,832 | |
| Income taxes | $\Omega$ | 9,917 | |
| Other liabilities | 2,571 | 88,088 | |
| Accrued expenses and deferred income | 55,228 | 45,954 | |
| Total short-term liabilities | 75,358 | 175,791 | |
| TOTAL EQUITY AND LIABILITIES | 639,776 | 816,349 |
| KSEK | Note | Share capital | Other contributed capital |
Retained earnings, including result for the period |
Total equity |
|---|---|---|---|---|---|
| Opening balance 1 January 2015 | 630 | 58,634 | 64,193 | 123,457 | |
| Result for the period and comprehensive income | $-159,542$ | $-159,542$ | |||
| Transactions with shareholders | |||||
| Share bonus program for personnel and Board members | 47 | 108,793 | 108,840 | ||
| Direct share issue to principal owner | 11 | 23,879 | 23,890 | ||
| Direct share issue, public listing | 244 | 554,756 | 555,000 | ||
| Issuance cost, net after deferred tax | $-11,088$ | $-11,088$ | |||
| Closing balance 31 December 2015 | 932 | 626,181 | 13,444 | 640,557 | |
| Opening balance 1 January 2016 | 932 | 626,181 | 13,444 | 640,557 | |
| Result for the period and comprehensive income | $-80,993$ | $-80,993$ | |||
| Transactions with shareholders | |||||
| Warrants issued | 4,853 | 4,853 | |||
| Closing balance 31 December 2016 | 4,10 | 932 | 631,034 | $-67,549$ | 564,418 |
| KSEK | Note | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating profit/loss before financial items | $-35,136$ | $-40,416$ | $-102,452$ | $-204,104$ | |
| Adjustments for non-cash items | 8 | 845 | 2,457 | 3,524 | 112,345 |
| Interest received | 87 | $\mathbf{0}$ | 95 | ||
| Interest paid | $-128$ | $-145$ | $-1,002$ | $-166$ | |
| Income taxes paid | $\Omega$ | 981 | $-9,917$ | 317 | |
| $-34,332$ | $-37,123$ | $-109,752$ | $-91,606$ | ||
| Increase/decrease in inventories | $-8,423$ | $-671$ | $-9,139$ | $-2,539$ | |
| Increase/decrease in trade receivables | 9,104 | 18,873 | 613 | $-2,800$ | |
| Increase/decrease in other current receivables | 8,095 | $-9,654$ | 1,005 | $-8,511$ | |
| Increase/decrease in trade payables | 9,728 | 17,655 | $-14,272$ | 21,893 | |
| Increase/decrease in other current operating liabilities | 8,167 | 50,458 | $-76,242$ | 77,906 | |
| Cash flow from changes in working capital | 26,672 | 76,661 | $-98,036$ | 85,949 | |
| Cash flow from operating activities | $-7,660$ | 39,538 | $-207,788$ | $-5,657$ | |
| Investing activities | |||||
| Acquisition of intangible assets | $\circ$ | $\mathbf{0}$ | $\overline{0}$ | $-355$ | |
| Acquisition of tangible assets | $-2,712$ | $-511$ | $-4,567$ | $-984$ | |
| Divestment/amortization of other financial assets | $\theta$ | $\Omega$ | 0 | 406 | |
| Increase/decrease in current financial investments | $\Omega$ | $\Omega$ | $\Omega$ | 157,908 | |
| Cash flow from investing activities | $-2,712$ | $-511$ | $-4,567$ | 156,975 | |
| Financing activities | |||||
| Increase/decrease in current financial liabilities | $\theta$ | $\Omega$ | 0 | $\Omega$ | |
| New share issue | $\theta$ | 564,722 | 0 | 564,722 | |
| Warrants issued | 718 | 4,853 | $\Omega$ | ||
| Cash flow from financing activities | 718 | 564,722 | 4,853 | 564,722 | |
| Net cash flow for the period | $-9,654$ | 603,749 | $-207,502$ | 716,040 | |
| Cash and cash equivalents at beginning of period | 518,248 | 112,347 | 716,096 | 56 | |
| Exchange rate differences in cash equivalents | 0 | $\mathbf{0}$ | 0 | $\Omega$ | |
| Cash and cash equivalents at the end of period | 508,594 | 716,096 | 508,594 | 716,096 |
| KSEK | Note | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Net sales | 37,126 | 36,340 | 113,737 | 154,799 | |
| Cost of goods sold | $-1,229$ | $-105$ | $-2,140$ | $-237$ | |
| Gross profit | 35,897 | 36,235 | 111,597 | 154,562 | |
| Marketing and distribution costs | $-9,385$ | $-6,986$ | $-24,738$ | $-19,411$ | |
| Administrative expenses | $-4,067$ | 6,778 | $-17,985$ | $-11,934$ | |
| Research and development costs | $-58,497$ | $-40,621$ | $-169,994$ | $-151,354$ | |
| Other operating income | 1,436 | 262 | 751 | 57 | |
| Other operating expenses | 0 | 0 | 0 | $-658$ | |
| Operating result before items affecting comparability | 7 | $-34,615$ | $-4,331$ | $-100,370$ | $-28,738$ |
| Items affecting comparability attributable to public listing costs | 7 | $-33,970$ | $-33,970$ | ||
| Items affecting comparability attributable to Share bonus program | $\overline{7}$ | $-1,596$ | $-139,671$ | ||
| Operating result | $-34,615$ | $-39,898$ | $-100,370$ | $-202,379$ | |
| Result from interests in Group companies | |||||
| Interest income and similar items | 87 | 95 | $\overline{2}$ | ||
| Interest expense and similar items | $-128$ | $-146$ | $-1,002$ | $-166$ | |
| Result after financial items | $-34,657$ | $-40,043$ | $-101,277$ | $-202,543$ | |
| Appropriations | $-1,246$ | 15,096 | $-1,246$ | 15,096 | |
| Result before tax | $-35,903$ | $-24,948$ | $-102,523$ | $-187,447$ | |
| Tax on profit for the period | 9 | 7,526 | 5,276 | 22,183 | 41,026 |
| Result for the period | $-28,377$ | $-19,672$ | $-80,340$ | $-146,421$ |
Total comprehensive income is the same as profit/loss for the period, as the parent company contains no items that are recognized under other comprehensive income.
| KSEK | Note | 31-12-2016 | 31-12-2015 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Tangible fixed assets | |||
| Equipment | 9,759 | 6,634 | |
| Financial fixed assets | |||
| Interest in Group companies | 816 | 573 | |
| Deferred tax assets | 9 | 66,574 | 44,391 |
| Total fixed assets | 77,148 | 51,598 | |
| Current assets | |||
| Inventories | |||
| Finished goods and goods for resale | 12,380 | 3,242 | |
| Current receivables | |||
| Receivables from parent company | $\Omega$ | 207 | |
| Trade receivables | 8,304 | 8,917 | |
| Other receivables | 3,855 | 5,500 | |
| Prepayments and accrued income | 16,461 | 15,613 | |
| Total current receivables | 28,619 | 30,237 | |
| Cash and bank deposits | 508,351 | 716,096 | |
| Total current assets | 549,351 | 749,575 | |
| TOTAL ASSETS | 626,499 | 801,173 |
| KSEK | Note | 31-12-2016 | 31-12-2015 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| Restricted equity | |||
| Restricted equity (37 281 486 shares) | 932 | 932 | |
| Statutory reserve | 11,327 | 11,327 | |
| Total restricted equity | 12,259 | 12,259 | |
| Unrestricted equity | |||
| Retained earnings | 17,746 | 164,167 | |
| Share premium reserve | 597,418 | 592,565 | |
| Result for the period | $-80,340$ | $-146,421$ | |
| Total unrestricted equity | 534,823 | 610,311 | |
| TOTAL EQUITY | 547,083 | 622,570 | |
| LIABILITIES | |||
| Untaxed reserves | |||
| Depreciation/amortization in excess of plan | 3,486 | 2,239 | |
| Tax allocation reserve | |||
| Total untaxed reserves | 3,486 | 2,239 | |
| Long-term liabilities | |||
| Liability to subsidiaries | 573 | 573 | |
| Total long-term liabilities | 573 | 573 | |
| Short-term liabilities | |||
| Liabilities to Group companies | |||
| Trade payables | 17,560 | 31,832 | |
| Current tax liability | 9,917 | ||
| Other liabilities | 2,571 | 88,088 | |
| Accrued expenses and deferred income | 55,228 | 45,954 | |
| Total short-term liabilities | 75,358 | 175,791 | |
| TOTAL EQUITY AND LIABILITIES | 626,499 | 801,173 |
| MSEK | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|
| Net revenue | 37.1 | 36.3 | 113.7 | 154.8 |
| Operating result before items affecting comparability | $-35.1$ | $-4.9$ | $-102.5$ | $-30.5$ |
| Operating result | $-35.1$ | $-40.4$ | $-102.5$ | $-204.1$ |
| Result for the period | $-27.8$ | $-31.9$ | $-81.0$ | $-159.5$ |
| Cash flow from operating activities | $-7.7$ | 39.5 | $-207.8$ | $-5.7$ |
| Cash and cash equivalents | 508.6 | 716.1 | 508.6 | 716.1 |
| Equity | 564.4 | 640.6 | 564.4 | 640.6 |
| Equity ratio in Group, percent | 88% | 78% | 88% | 78% |
| Total assets | 639.8 | 816.3 | 639.8 | 816.3 |
| Weighted average number of shares, before dilution | 37,281,486 | 30,322,000 | 37,281,486 | 26,497,361 |
| Weighted average number of shares, after dilution*) | 37,667,121 | 37,281,486 | 37,487,937 | 37,281,486 |
| Earnings per share before dilution, SEK | $-0.75$ | $-1.05$ | $-2.17$ | $-6.02$ |
| Earnings per share after dilution, SEK*) | $-0.75$ | $-1.05$ | $-2.17$ | $-6.02$ |
| Equity per share before dilution, SEK | 15.14 | 21.13 | 15.14 | 24,17 |
| Equity per share after dilution, SEK*) | 14.98 | 17.18 | 15.06 | 17.18 |
| Number of employees at end of period | 62 | 48 | 62 | 48 |
| Number of employees in R&D at end of period | 44 | 35 | 44 | 35 |
| R&D costs as a percentage of operating expenses | 81% | 99% | 80% | 83% |
| Equity ratio, % | Equity divided by total capital |
|---|---|
| Average number of shares, | Weighted average number of shares before |
| before dilution | adjustment for dilution effect of net shares |
| Average number of shares, | Weighted average number of shares adjustment |
| after dilution | for the dilution effect of new shares |
| Earnings per share before | Result divided by the weighted average number |
| dilution, SEK | of shares outstanding before dilution |
| Earnings per share after | Result divided by the weighted average number |
| dilution, SEK | of shares outstanding after dilution |
| Equity per share before | Equity divided by the weighted number of shares |
| dilution, SEK | at the period before dilution |
| Equity per share after | Equity divided by the weighted number of shares |
| dilution, SEK | at the end of the period after dilution |
| R&D cost as a percentage of operating expenses |
Research and development costs divided by operating expenses, excluding items affecting comparability (marketing and distribution costs, administrative expenses and research and development costs) |
*) The dilution effect is calculated according to IAS 33.
Camurus AB, Corp. ID no. 556667-9105 is the parent company of the Camurus Group. Up until 7 October 2015, Camurus AB's registered offices were in Malmö, Sweden. The company is now based in Lund. Sweden, at Ideon Science Park, 223 70 Lund.
Camurus AB Group's interim report for the fourth quarter 2016 was approved for publication in accordance with a decision from the Board on 15 February, 2017.
All amounts are stated in SEK thousand (KSEK), unless otherwise indicated. Figures in brackets refer to the year-earlier period.
The consolidated financial statements for the Camurus AB Group ('Camurus') have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU, as well as the Swedish Financial Reporting Board's Recommendation RFR 1 Supplementary Accounting Rules for Groups, and the Swedish Annual Accounts Act.
This interim report has been drawn up in accordance with IAS 34, Interim Financial Reporting, the Swedish Annual Accounts Act and RFR 1 Supplementary Accounting Rules for Groups.
The parent company statements have been prepared in accordance with the Annual Accounts Act and recommendation RFR 2 Accounting for legal entities from the Swedish Financial Reporting Board. The application of RFR 2 means that the parent company in the interim report for the legal entity shall apply all EU-approved IFRS standards and statements as far as possible within the framework of the Annual Accounts Act, the Pension Obligations Vesting Act (Tryggandelagen) and taking into
consideration the relationship between accounting and taxation. The parent company's accounting policies are the same as for the Group, unless otherwise stated in Note 2.2.
The most important accounting policies that are applied in the preparation of these consolidated financial statements are detailed below
2.1.1 Changes to accounting policies and disclosures New or revised IFRS standards that have come into force have not had any material impact on the Group.
The parent company applies accounting policies that differ from those of the Group in the cases stated below.
All expenses that relate to the development of internally generated intangible assets are recognized as expenses as they arise.
Interests in subsidiaries are reported at cost, less any impairment losses. The cost includes acquisition-related expenses and any additional considerations.
When there is an indication that interests in subsidiaries have decreased in value, a calculation is made of the recoverable amount. If this amount is lower than the reported amount, an impairment is carried out. Impairment losses are recognized under the item "Result from interests in Group companies".
Group contributions paid by the parent company to subsidiaries and Group contributions received from subsidiaries by the parent company are recognized as appropriations.
IAS 39 is not applied in the parent company and financial instruments are measured at cost
Until 3 December 2015, the group had a share-based compensation plan where the regulation should be made in shares and where the company received services from employees as consideration for the Group's own equity instruments (shares). The fair value of the service, which eligible employees to the allocation of shares, was expensed and the total amount to be expensed was based on the fair value of the shares granted.
At each reporting period Camurus assessed its estimates of the number of shares expected to vest based on the non-market vesting conditions and service conditions. Any deviation from the original estimates as the review gave rise to, were recognized in the income statement and corresponding adjustments made to equity
When bonus shares were exercised, the Company issued new shares. The proceeds received net of any directly attributable transaction costs are credited to share capital (quota value) and other capital contributions. The social security contributions which arose on the allocation of the shares was regarded as an integral part of the award, and the cost was treated as a cash-settled share-based payment.
Company management have established that the Group as a whole constitutes one segment based on the information managed by the CEO, in consultation with the Board, and which is used as a basis for allocating resources and evaluating results.
To follow is a breakdown of revenues from all products and services.
| KSEK | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|
| Sales of development related goods and services | 21,336 | 25,859 | 68.112 | 93,845 |
| Milestone payments | 14,699 | 10,150 | 34,217 | 52,850 |
| Licensing revenues | 60 | 45 | 8,485 | 7,238 |
| Other | 1.001 | 286 | 2.923 | 866 |
| Total | 37,126 | 36,340 | 113,737 | 154,799 |
Revenues from external customers is allocated by country, based on where the customers are located.
| KSEK | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|
| Europé | 2,127 | 12,306 | 22,921 | 108,067 |
| (of which Sweden) | (67) | (369) | (3,727) | (2,275) |
| North America | 34,362 | 23.996 | 87,359 | 39,635 |
| Other geographical areas | 637 | 38 | 3.457 | 7,097 |
| Totalt | 37,126 | 36,340 | 113,737 | 154,799 |
Revenue during the fourth quarter of approximately MSEK 50.9 (35.1) relates to one single external customer.
All fixed assets are located in Sweden.
Earnings per share before dilution is calculated by dividing the result attributable to shareholders of the parent company by a weighted average number of ordinary shares outstanding during the period. During the period, no shares held as treasury shares by the parent company have been repurchased.
| KSEK | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|
| Result attributable to parent company shareholders | $-27.811$ | $-31.850$ | $-80.993$ | $-159.542$ |
| Total | $-27.811$ | -31.850 | $-80.993$ | $-159.542$ |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 25,209 | 37,281 | 26,497 |
In order to calculate earnings per share, the number of existing ordinary shares is adjusted for the dilutive effect of the weighted average number of outstanding ordinary shares. The parent company has one category of ordinary shares with anticipated dilution effect in the form of warrants. For warrants, a calculation is made of the number of shares that could have been purchased at fair value (calculated as the average market price for the year for the parent company's shares), at an amount corresponding to the monetary value of the subscription rights linked to outstanding warrants. The number of shares calculated as above is compared to the number of shares that would have been issued assuming the warrants are exercised.
| KSEK | 2016 Oct-Dec |
2015 Oct-Dec |
2016 Jan - Dec |
2015 Jan - Dec |
|---|---|---|---|---|
| Result attributable to parent company shareholders | $-27.811$ | -31.850 | $-80.993$ | $-159,542$ |
| Total | $-27,811$ | $-31.850$ | $-80.993$ | $-159.542$ |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 30,322 | 37,281 | 26,497 |
| Adjustments: | ||||
| warrants (thousands) $\sim$ |
386 | 207 | 1.047 | |
| share issues (thousands) $\sim$ |
6.959 | 9,737 | ||
| Weighted average number of ordinary shares in calculation of earnings per share after dilution (thousands) |
37,667 | 37,281 | 37,488 | 37,281 |
All of the Group's financial instruments that are measured at amortized cost are short-term and expire within one year. The fair value of these instruments is deemed to correspond to their reported amounts, since discounting effects are minimal.
| Carrying amount, KSEK | 31-12-2016 31-12-2015 | |
|---|---|---|
| Loans and receivables | ||
| Trade receivables | 8,304 | 8,917 |
| Receivables from Group companies | 207 | |
| Other receivables | ||
| Cash and cash equivalents | 508,594 | 716,096 |
| Total | 516,898 | 725,220 |
| Other liabilities | ||
| Other financial liabilities | ||
| Liabilities to Group companies | ||
| Trade payables | 17,560 | 31,832 |
| Other current liabilities | 191 | 191 |
| Total | 17,751 | 32,023 |
Investor relations services have been acquired from Piir & Partners AB, whose representative is a member of the management team. Pricing is done in accordance with allocation of costs in relation to utilization rate and on market terms.
At the end of the period the company had a debt to Piir & Partner AB regarding these services that amounted to MSEK 0.3 (0.2). There were no other receivables or liabilities.
Up and until fourth quarter this year, no items affecting comparability has arisen.
The costs charged to the previous year's results relate to listing expenses, in connection with preparations of the public listing of the company's shares on Nasdaq, Stockholm, and to the share bonus program, implemented in 2013 and fulfilled December 3, 2015 when Camurus' shares were listed on the stock exchange.
Following below is the consolidated income statement as it would have looked had the listing expenses and the cost for the share bonus program not been separated out.
| 2016 | 2015 | 2016 | 2015 | ||
|---|---|---|---|---|---|
| KSEK | Note | Oct-Dec | Oct-Dec | Jan-Dec | Jan - Dec |
| Revenues | 3 | 37,126 | 36,340 | 113,737 | 154,799 |
| Cost of goods sold | $-1,229$ | $-105$ | $-2,140$ | $-237$ | |
| Gross profit | 35,897 | 36,235 | 111,597 | 154,562 | |
| Marketing and distribution costs | $-9,385$ | $-7,867$ | $-24,738$ | $-31,338$ | |
| Administrative expenses | $-4,067$ | $-31,226$ | $-17,985$ | $-74,790$ | |
| Research and development costs | $-59,017$ | $-37,821$ | $-172,077$ | $-251,937$ | |
| Other operating income | 1,436 | 262 | 751 | -57 | |
| Other operating expenses | $-658$ | ||||
| Operating result | 6 | $-35,136$ | $-40,416$ | $-102,452$ | $-204,104$ |
| Finance income | 87 | 1 | 95 | $\overline{2}$ | |
| Finance expenses | $-128$ | $-145$ | $-1,002$ | $-166$ | |
| Net financial items | $-41$ | $-144$ | $-907$ | $-164$ | |
| Result before tax | $-35,178$ | -40,560 | $-103,359$ | $-204,268$ | |
| Income tax | 9 | 7,367 | 8,711 | 22,367 | 44,727 |
| Result for the period | $-27,811$ | $-31,850$ | $-80,993$ | $-159,542$ |
Adjustment for non-cash items:
| 2016 | 2015 | 2016 | 2015 | |
|---|---|---|---|---|
| KSEK | Oct-Dec | Oct-Dec | Jan – Dec | Jan - Dec |
| Depreciation | 845 | 964 | 3,524 | 3.552 |
| Costs of share bonus program | $\overline{0}$ | 1.493 | 0 | 108,793 |
| Total | 845 | 2,457 | 3,524 | 112,345 |
Tax for the quarter amounted to MSEK 7.4 (8.7), primarily attributable to the negative result.
The change in equity for the quarter is mainly attributable to the loss.
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 16 February, 2017.
CAMURUS AB Ideon Science Park, SE-223 70 Lund, Sweden
Phone: +46 286 57 30 Fax: +46 286 57 39 E-mail: [email protected]
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