Quarterly Report • May 17, 2016
Quarterly Report
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INNOVATIVE NANOSCALE THERAPEUTICS
Financial notes "We are in a strong growth phase and on track to deliver on all our key objectives for this year."
| Q2 2016 | 14 July 2016 |
|---|---|
| Q3 2016 | 8 November 2016 |
| Full Year Report 2016 | 16 February 2017 |
| Annual Report 2016 | 30 March 2017 |
| Q1 2017 | 3 May 2017 |
| Annual General Meeting | 3 May 2017 |
| 2017 |
Camurus is a Swedish research-based pharmaceutical company committed to developing and commercializing innovative and differentiated medicines for the treatment of severe and chronic conditions. The company's share is listed on Nasdaq Stockholm under the ticker "CAMX".
CAMURUS INTERIM REPORT FIRST QUARTER 2016 2
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:
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
• Positive results from a Phase 2 study of the blockade of opioid effects by CAM2038 in patients with opioid dependence.
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.
CAM2029 is a subcutaneous depot of octreotide, being developed for treatment of patients with acromegaly or neuroendocrine tumors (NET). CAM2029 is being developed by Novartis, as a new treatment alternative to the current marketleading product Sandostatin® LAR® , with global sales of USD 1.63 billion in 2015. CAM2029 is provided ready-for-use in prefilled syringe and is administered as a simple subcutaneous injection, 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 may contribute to improved treatment effects in patients who do not respond satisfactorily to current treatments.
Camurus and Novartis have during the period completed a Phase 2 study of CAM2029 in two patient groups with acromegaly and neuroendocrine tumors. Results from the study are expected towards the end of Q2 2016. Novartis and Camurus are in parallel continuing manufacturing preparations for the upcoming Phase 3 trials of CAM2029.
CAM2038 includes subcutaneous weekly and monthly depots of buprenorphine, developed by Camurus and its partner Braeburn Pharmaceuticals for treatment of opioid dependence on painkillers or heroin. The CAM2038 products address a number of shortcomings of currently available medications, including a limited patient compliance with frequent relapses and problems associated with misuse abuse and diversion of current daily medications. To date, the CAM2038 products have been evaluated in three Phase 1/2 clinical trials, which evaluated the safety and tolerability as well as pharmacokinetic and pharmacodynamic properties of the products in a total of
176 individuals (opioid-dependent patients and healthy volunteers under naltrexone blockage). Four more trials, including two Phase 3 studies, are currently ongoing. Good safety profiles and pharmacokinetic and pharmacodynamic properties suitable for weekly and monthly dosing, respectively, have been demonstrated in all completed clinical trials.
Two Phase 3 studies are ongoing to document efficacy and long-term safety of CAM2038 in patients with opioid use disorder: a Phase 3 randomized, double-blind, doubledummy, active-controlled, 24-week efficacy trial and a Phase 3 open-label, 48-week safety study. Patient recruitment goals for both Phase 3 studies have been accomplished. Phase 3 efficacy results are expected in Q4, 2016. After the period, positive top-line results were reported from a pivotal Phase 2 opioid challenge study evaluating the blockade of subjective opioid effects by CAM2038.
In addition to treatment of opioid dependence, CAM2038, weekly and monthly depots, are also being developed for treatment of chronic pain. CAM2038 provide rapid and prolonged exposure to buprenorphine, with potential for round-the-clock pain relief, while decreasing the risks of respiratory depression and fatal overdoses associated with full mu-opioid agonists such as morphine, oxycodone and fentanyl. The properties of CAM2038 conform to the guidelines and recommendations for treatments of chronic pain, i.e. combining of stable efficacious plasma levels with a reduced risk of misuse, abuse and illicit diversion.
A Phase 2 study was initiated in opioid dependent patients with chronic pain. The study is designed to assess pharmacokinetics, pain and safety after repeated dosing of the CAM2038 weekly and monthly products.
CAM2032 is a new subcutaneous depot product that is being developed by Camurus for treatment of prostate cancer. Other possible indications include premature sexual maturation and endometriosis. The product is based on the active ingredient leuprolide, belonging to the class of gonadotropin releasing hormones. CAM2032 is, as the first product in its class, being developed for easy subcutaneous injection, also by patients themselves, in the form of a small volume injection with a duration of one month.
CAM2032 has been studied in a recently completed repeat dose Phase 2 study in patients with advanced metastatic prostate cancer. The data base has been locked during the period and study results are expected by end of Q2 2016.
Several new product candidates are being evaluated in pharmaceutical and preclinical studies, supported by initial market research. The development includes formulation optimization with respect to release performance, stability and pharmacological properties, according to predefined target product profiles.
During the period, we have evaluated new product candidates with positive outcomes from stability, pharmacokinetic and safety studies. Target indications for these candidates include diabetes, pain and cancer supportive care. Following the initial evaluations, supporting toxicology studies have been initiated for two product candidates with the aim to initiate clinical development in Q4 2016.
Camurus is also a number of collaboration projects with international pharmaceutical companies where new product candidates based on Camurus' formulation technology and the partner company's patented active ingredient are evaluated. These collaborations often involve formulation development and assessments with respects to pre-specified technical and market related objectives. The time frame of these feasibility studies is typically 6–12 months. After successful evaluations, 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 ongoing with international pharmaceutical companies, based on Camurus' FluidCrystal® technologies and the partners' proprietary drug substance. These projects target different indications such as cancer, obesity, diabetes and viral infection. During the first quarter, a license agreement was signed with the Boston-based biotech company Rhythm, regarding the use of Camurus FluidCrystal® injection depot for developing a once-weekly formulation of setmelanotide (RM-493), a novel melanocortin-4 receptoragonist (MC4R) for treatment of genetic obesity. According to the agreement, Rhythm obtains global rights to use, manufacture and commercialise a subcutaneous formulation of setmelanotide for once-weekly dosing. Rhythm is currently preparing GMP-manufacturing of the once-weekly setmelanotide FluidCrystal® formulation for the start of a clinical Phase 1 trial.
episil® is a medical device for treatment of inflammatory and painful conditions in the oral cavity. The product provides effective pain relief and works by spreading and adhering to the oral mucosa as a thin bioadhesive film, which acts as a longacting protective barrier that reduces pain and protection of sore and inflamed mucosal surfaces, such as caused by oral mucositis, a common and serious side effect of cancer treatment. episil® transforms into a protective layer of gel in contact with the buccal membrane, offering effective pain relief for up to 8 hours.
Camurus partner Solasia Pharma has initiated the market registration process for episil® in China and Japan. After the period, a distribution agreement was signed with R-Pharm US for the distribution of episil® on the US market.
Revenues during the first quarter amounted to MSEK 20,2 (58,6). A significant part of Camurus' income come from signing fees and milestone payments from our partners and license agreements. These events vary between quarters. Additional revenues come from project activities and product sales.
Marketing, business development and distribution costs in the first quarter were MSEK 4.3 (2.9).
Administrative expenses amounted to MSEK 3.7 (5.6). 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 costs.
Research and development costs in the first quarter amounted to MSEK 35.4 (37.4), including depreciation and amortization of tangible and intangible assets.
Other operating incomes/expenses mainly consist of currency exchange losses in operational activities of a total of MSEK -1.6 (0.5), as a result of fluctuations in the Swedish krona against the euro and the US dollar.
Depreciation and amortization during the first quarter amounted to MSEK 0.8 (0.8).
The operating result for the first quarter was MSEK -24.9 (13.1).
Financial items for the period amounted to MSEK -0,0 (-0,0). Tax for the quarter was MSEK 5.5 (-2.9). The difference compared to the previous year is mainly attributable to deferred tax for losses during the quarter.
The result for the period was MSEK -19.4 (10.2), corresponding to an earnings per share of SEK -0.52 (0.41) before and after dilution.
Cash flow from operating activities, before change in working capital, was negative for the first quarter and amounted to MSEK -34.0 (13.7).
Working capital affected the cash flow with MSEK -110,1 (-54,9), related to a payments of withheld tax and social security costs for the share-based bonus program, which was effectuated in connection with the listing of the Company's shares on Nasdaq Stockholm.
Cash flow from investing activities amounted to MSEK -0.1 (157.5). The difference compared with the year-earlier period mainly relates to the separation of the company's cashpool from the Sandberg Development group account.
The Company's cash position at the end of the quarter was MSEK 571.9 (116.4). The difference compared with the year before is mainly attributable to the proceeds from the listing of Camurus' shares on Nasdaq, Stockholm.
There were no outstanding loans as of March 31, 2016, and no loans have been taken up since.
Consolidated equity as of March 31, 2016, was MSEK 621.1 (133.7). The increase in equity compared to the same date last year relates mainly to the issued proceeds in conjunction with the listing of the Company's shares on Nasdaq Stockholm on December 3, 2015.
No acquisitions or divestments have occurred during the quarter.
Camurus' share is listed on Nasdaq Stockholm since the December 3, 2015. At the end of the period, the total number of shares in the company was 37,281,486 (25,208,560).
.
Revenues for the first quarter amounted to MSEK 20.2 (58.6) and the result after tax was MSEK -19.0 (10.3).
On March 31, 2016, equity in the Parent Company amounted to MSEK 603.6 (102.7). The difference compared with the yearearlier period is mainly attributable to the issued proceeds in connection with the stock market listing of the company's share.
Total assets at the end of the period was MSEK 661.4 (190.4), of which cash and cash equivalents constituted MSEK 571.9 (116.4).
At the end of the period, Camurus had 49 (45) employees, of whom 36 (34) were within research and development. The average number of employees during the quarter was 48 (40).
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.
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 applications for approval of clinical trials and market approval, 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 yearend report for 2015
AUDIT
This report has not been reviewed by the company's auditors.
For further information, please contact: Fredrik Tiberg, Chief Executive Officer Tel.: +46 46 286 46 92, e-mail: [email protected].
Lund, May 17, 2016 Camurus AB Board of Directors
| 2016 | 2015 | 2015 | ||
|---|---|---|---|---|
| KSEK | Note | Jan – Mar |
Jan – Mar |
Jan - Dec |
| Net sales | 3 | 20,246 | 58,568 | 154,799 |
| Cost of goods sold | -63 | -28 | -237 | |
| Gross profit | 20,183 | 58,540 | 154,562 | |
| Marketing and distribution costs | -4,298 | -2,930 | -19,411 | |
| Administrative expenses | -3,715 | -5,641 | -11,934 | |
| Research and development costs | -35,394 | -37,368 | -153,080 | |
| Other operating income | 16 | 506 | 57 | |
| Other operating expenses | -1,650 | 0 | -658 | |
| Operating result before items affecting comparability |
7 | -24,857 | 13,106 | -30,464 |
| Items affecting comparability attributable to public listing costs | 7 | 0 | 0 | -33,970 |
| Items affecting comparability attributable to Share bonus program | 7 | 0 | 0 | -139,671 |
| Operating result | 6 | -24,857 | 13,106 | -204,104 |
| Finance income | 2 | 0 | 2 | |
| Finance expenses | -37 | -8 | -166 | |
| Net financial items | -35 | -8 | -164 | |
| Result before tax | -24,893 | 13,098 | -204,268 | |
| Income tax | 9 | 5,476 | -2,882 | 44,727 |
| Result for the period | -19,416 | 10,217 | -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.
| 2016 | 2015 | 2015 | |
|---|---|---|---|
| SEK | Jan – Mar |
Jan – Mar |
Jan - Dec |
| Earnings per share before dilution, SEK | -0.52 | 0.41 | -6.33 |
| Earnings per share after dilution, SEK | -0.52 | 0.41 | -6.33 |
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 program had no impact on revenue and earnings in the first quarter 2015. However the impact on the 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 | 31-03-2016 | 31-03-2015 | 31-12-2015 | KSEK | Note | 31-03-2016 | 31-03-2015 | 31-12-2015 |
|---|---|---|---|---|---|---|---|---|---|
| ASSETS | EQUITY | ||||||||
| Fixed assets | |||||||||
| Intangible assets | Equity attributable to parent company shareholder |
||||||||
| Capitalized development expenditure | 20,303 | 22,385 | 20,823 | Share capital | 932 | 630 | 932 | ||
| Tangible assets | Other contributed capital | 626,181 | 58,634 | 626,181 | |||||
| Equipment | 6,450 | 6,816 | 6,634 | Retained earnings, including result for the period | -5,972 | 74,409 | 13,444 | ||
| Total equity | 4, 10 | 621,141 | 133,673 | 640,557 | |||||
| Financial assets | |||||||||
| Long-term receivables Group companies |
0 | 406 | 0 | LIABILITIES | |||||
| Deferred tax receivables | 9 | 44,794 | 0 | 39,317 | |||||
| Total fixed assets | 71,546 | 29,607 | 66,775 | Long-term liabilities | |||||
| Deferred tax liability | 0 | 8,501 | 0 | ||||||
| Current assets | Total long-term liabilities | 0 | 8,501 | 0 | |||||
| Inventories Finished goods and goods for resale |
3,157 | 798 | 3,241 | Short-term liabilities | |||||
| Liabilities to Group companies | 0 | 229 | 0 | ||||||
| Current receivables | |||||||||
| Receivables from Group companies | 0 | 0 | 207 | Trade payables |
7,566 | 7,057 | 31,832 | ||
| Trade receivables | 14,170 | 55,006 | 8,917 | Income taxes | 0 | 12,278 | 9,917 | ||
| Other receivables | 6,015 | 961 | 5,500 | Other liabilities | 3,890 | 3,749 | 88,088 | ||
| Prepayments and accrued income | 9,381 | 9,598 | 15,613 | Accrued expenses and deferred income |
43,589 | 46,895 | 45,954 | ||
| Total short-term liabilities | 55,045 | 70,208 | 175,791 | ||||||
| Cash and cash equivalents | 571,916 | 116,412 | 716,096 | TOTAL EQUITY AND LIABILITIES | 676,186 | 212,382 | 816,349 | ||
| Total current assets | 604,640 | 182,775 | 749,574 | ||||||
| TOTAL ASSETS | 676,186 | 212,382 | 816,349 |
| Other | Retained earnings, | ||||
|---|---|---|---|---|---|
| KSEK | Note | Share capital |
contributed capital |
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 | 10,217 | 10,217 | |||
| Transaction with shareholders | - | - | - | - | |
| Closing balance 31 March 2015 | 630 | 58,634 | 74,409 | 133,673 | |
| 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 |
4,10 | 932 | 626,181 | 13,444 | 640,557 |
| Opening balance 1 januari 2016 | 932 | 626,181 | 13,444 | 640,557 | |
| Result for the period and comprehensive income |
-19,416 | -19,416 | |||
| Transactions with shareholders | - | - | - | - | |
| Closing balance 31 March 2016 | 932 | 626,181 | -5,973 | 621,141 |
| KSEK | Note | 2016 Jan - Mar |
2015 Jan - Mar |
2015 Jan - Dec |
|---|---|---|---|---|
| Operating activities | ||||
| Operating profit/loss before financial items | -24,857 | 13,106 | -204,104 | |
| Adjustments for non-cash items | 8 | 840 | 849 | 112,345 |
| Interest received | 2 | 0 | 2 | |
| Interest paid | -37 | -8 | -166 | |
| Income taxes paid | -9,917 | -240 | 317 | |
| -33,969 | 13,707 | -91,606 | ||
| Increase/decrease in inventories | 84 | -96 | -2,539 | |
| Increase/decrease in trade receivables | -5,253 | -48,888 | -2,800 | |
| Increase/decrease in other current receivables | 5,923 | 2,249 | -8,511 | |
| Increase/decrease in trade payables | -24,266 | -2,881 | 21,893 | |
| Increase/decrease in other current operating liabilities | -86,564 | -5,263 | 77,906 | |
| Cash flow from changes in working capital | -110,076 | -54,879 | 85,949 | |
| Cash flow from operating activities | -144,045 | -41,172 | -5,657 | |
| Investing activities | ||||
| Acquisition of intangible assets | 0 | -355 | -355 | |
| Acquisition of tangible assets | -135 | -25 | -984 | |
| Divestment/amortization of other financial assets | 0 | 0 | 406 | |
| Increase/decrease in current financial investments | 0 | 157,908 | 157,908 | |
| Cash flow from investing activities | -135 | 157,528 | 156,975 | |
| Financing activities | ||||
| Increase/decrease in current financial liabilities | 0 | 0 | 0 | |
| New share issue | 0 | 0 | 564,722 | |
| Paid/received group contribution | 0 | 0 | 0 | |
| Cash flow from financing activities | 0 | 0 | 564,722 | |
| Net cash flow for the period | -144,180 | 116,356 | 716,040 | |
| Cash and cash equivalents at beginning of period | 716,096 | 56 | 56 | |
| Exchange rate differences in cash equivalents | 0 | 0 | 0 | |
| Cash and cash equivalents at the end of period | 571,916 | 116,412 | 716,096 |
CAMURUS INTERIM REPORT FIRST QUARTER 2016 14
| 2016 | 2015 | 2015 | ||
|---|---|---|---|---|
| KSEK | Note | Jan - Mar |
Jan - Mar |
Jan - Dec |
| Net sales | 20,246 | 58,568 | 154,799 | |
| Cost of goods sold | -63 | -28 | -237 | |
| Gross profit | 20,183 | 58,540 | 154,562 | |
| Marketing and distribution costs | -4,298 | -2,930 | -19,411 | |
| Administrative expenses | -3,715 | -5,641 | -11,934 | |
| Research and development costs | -34,873 | -37,203 | -151,354 | |
| Other operating income | 16 | 506 | 57 | |
| Other operating expenses | -1,650 | 0 | -658 | |
| Operating result before items affecting comparability | 7 | -24,337 | 13,272 | -28,738 |
| Items affecting comparability attributable to public listing costs | 7 | - | - | -33,970 |
| Items affecting comparability attributable to Share bonus program | 7 | - | - | -139,671 |
| Operating result | -24,337 | 13,272 | -202,379 | |
| Result from interests in Group companies |
0 | 0 | 0 | |
| Interest income and similar items | 2 | 0 | 2 | |
| Interest expense and similar items | -37 | -8 | -166 | |
| Result after financial items | -24,372 | 13,264 | -202,543 | |
| Appropriations | 0 | 0 | 15,096 | |
| Result before tax | -24,372 | 13,264 | -187,447 | |
| Tax on profit for the period | 9 | 5,362 | -2,918 | 41,026 |
| Result for the period | -19,010 | 10,346 | -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 | 31-03-2016 | 31-03-2015 | 31-12-2015 |
|---|---|---|---|---|
| ASSETS | ||||
| Fixed assets | ||||
| Tangible fixed assets |
||||
| Equipment | 6,450 | 6,816 | 6,634 | |
| Financial fixed assets | ||||
| Interest in Group companies | 573 | 573 | 573 | |
| Deferred tax assets | 9 | 49,753 | 238 | 44,391 |
| Total fixed assets | 56,775 | 7,627 | 51,598 | |
| Current assets | ||||
| Inventories | ||||
| Finished goods and goods for resale | 3,157 | 798 | 3,242 | |
| Current receivables | ||||
| Receivables from parent company | 0 | 0 | 207 | |
| Trade receivables | 14,170 | 55,006 | 8,917 | |
| Other receivables | 6,015 | 962 | 5,500 | |
| Prepayments and accrued income | 9,383 | 9,598 | 15,613 | |
| Total current receivables | 29,568 | 65,566 | 30,237 | |
| Cash and bank deposits | 571,916 | 116,411 | 716,096 | |
| Total current assets | 604,642 | 182,774 | 749,575 | |
| TOTAL ASSETS | 661,417 | 190,402 | 801,173 |
| KSEK Note |
31-03-2016 | 31-03-2015 | 31-12-2015 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity (37 281 486 shares) |
932 | 630 | 932 |
| Statutory reserve | 11,327 | 11,327 | 11,327 |
| Total restricted equity | 12,259 | 11,957 | 12,259 |
| Unrestricted equity | |||
| Retained earnings | 17,746 | 55,373 | 164,167 |
| Share premium reserve | 592,565 | 25,017 | 592,565 |
| Result for the period |
-19,010 | 10,346 | -146,421 |
| Total unrestricted equity | 591,300 | 90,736 | 610,311 |
| Total equity | 603,560 | 102,693 | 622,570 |
| LIABILITIES | |||
| Untaxed reserves | |||
| Depreciation/amortization in excess of plan | 2,239 | 1,825 | 2,239 |
| Tax allocation reserve | 0 | 15,510 | 0 |
| Total untaxed reserves | 2,239 | 17,335 | 2,239 |
| Long-term liabilities | |||
| Liability to subsidiaries | 573 | 166 | 573 |
| Short-term liabilities | |||
| Liabilities to Group companies | 0 | 229 | 0 |
| Trade payables | 7,566 | 7,057 | 31,832 |
| Current tax liability | 0 | 12,278 | 9,917 |
| Other liabilities | 3,890 | 3,749 | 88,088 |
| Accrued expenses and deferred income | 43,589 | 46,895 | 45,954 |
| Total short-term liabilities | 57,858 | 70,208 | 175,791 |
| TOTAL EQUITY AND LIABILITIES | 661 417 | 190 402 | 801 173 |
CAMURUS INTERIM REPORT FIRST QUARTER 2016 16
| MSEK | 2016 Jan - Mar |
2015 Jan - Mar |
2015 Jan - Dec |
|---|---|---|---|
| Net revenue | 20,2 | 58,6 | 154,8 |
| Operating result before items affecting comparability |
-24,9 | 13,1 | -30,5 |
| Operating result | -24,9 | 13,1 | -204,1 |
| Result for the period |
-19,4 | 10,2 | -159,5 |
| Cash flow from operating activities | -144,0 | -41,2 | -5,7 |
| Cash and cash equivalents | 571,9 | 116,4 | 716,1 |
| Equity | 621,1 | 133,7 | 640,6 |
| Equity ratio in Group, percent | 92% | 63% | 78% |
| Total assets | 676,2 | 212,4 | 816,3 |
| Average number of shares, before dilution | 37 281 486 |
25 208 560 |
25 208 560 |
| Average number of shares, after dilution | 37 281 486 |
25 208 560 |
26 497 361 |
| Earnings per share before dilution, SEK | -0,52 | 0,41 | -6,33 |
| Earnings per share after dilution, SEK | -0,52 | 0,41 | -6,33 |
| Equity per share before dilution, SEK | 16,66 | 5,30 | 25,41 |
| Equity per share after dilution, SEK | 16,66 | 5,30 | 17,18 |
| Number of employees at end of period | 49 | 45 | 48 |
| Number of employees in R&D at end of period | 36 | 34 | 35 |
| R&D costs as a percentage of operating expenses | 82% | 81% | 83% |
| Equity ratio, % | Equity divided by total capital |
|---|---|
| Average number of shares, before dilution |
Average number of shares before adjustment for the dilution effect of new shares |
| Average number of shares, after dilution | Average number of shares adjusted for the dilution effect of new shares |
| Earnings per share before dilution, SEK | Result divided by the average number of shares outstanding before dilution |
| Earnings per share after dilution, SEK | Result divided by the average number of shares outstanding after dilution |
| Equity per share before dilution | Equity divided by the number of shares at the end of the period before dilution |
| Equity per share after dilution | Equity divided by the number of shares at the end of the period after dilution |
| R&D costs 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). |
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 first quarter 2016 was approved for publication in accordance with a decision from the Board on 16 May 2016.
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 Jan - Mar |
2015 Jan - Mar |
2015 Jan - Dec |
|---|---|---|---|
| Sales of development related goods and services | 15,971 | 29,858 | 93,845 |
| Milestone payments | 0 | 21,650 | 52,850 |
| Licensing revenues | 4,275 | 7,013 | 7,238 |
| Other | 0 | 47 | 866 |
| Total | 20,246 | 58,568 | 154,799 |
Revenues from external customers is allocated by country, based on where the customers are located.
| 2016 | 2015 | 2015 | |
|---|---|---|---|
| KSEK | Jan - Mar |
Jan - Mar |
Jan - Dec |
| Europe | 7,549 | 51,487 | 108,067 |
| (of which Sweden) | (1,673) | (267) | (2,275) |
| North America | 12,572 | 49 | 39,635 |
| Other geographical areas | 125 | 7,032 | 7,097 |
| Totalt | 20,246 | 58,568 | 154,799 |
Revenue during first quarter of approximately MSEK 7.9 (31.4) 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 Jan - Mar |
2015 Jan - Mar |
2015 Jan - Dec |
|---|---|---|---|
| Result attributable to parent company shareholders | -19,146 | 10,217 | -159,542 |
| Total | -19,146 | 10,217 | -159,542 |
| Weighted average number of ordinary shares outstanding (thousands) | 37,281 | 25,209 | 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 Jan - Mar |
2015 Jan - Mar |
2015 Jan - Dec |
|---|---|---|---|
| Result attributable to parent company shareholders |
-19,146 | 10,217 | -159,542 |
| Total | -19,146 | 10,217 | -159,542 |
| Weighted average number of ordinary shares outstanding (thousands) | 37,281 | 25,209 | 26,497 |
| Adjustments: | |||
| - warrants (thousands) |
1,047 | ||
| - Share issues (thousands) |
9,037 | ||
| Weighted average number of ordinary shares in calculation of earnings per share | |||
| after dilution (thousands) |
37,281 | 25,209 | 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 | 31-03-2016 | 31-03-2015 | 31-12-2015 |
|---|---|---|---|
| Loans and receivables | |||
| Trade receivables | 14,170 | 55,066 | 8,917 |
| Receivables from Group companies | - | - | 207 |
| Other receivables | - | - | - |
| Cash and cash equivalents | 571,916 | 116,412 | 716,096 |
| Total | 586,086 | 171,418 | 725,220 |
| Other liabilities | |||
| Other financial liabilities | - | - | - |
| Liabilities to Group companies | - | 229 | - |
| Trade payables | 7,566 | 7,057 | 31,641 |
| Other current liabilities | 191 | 191 | 191 |
| Total | 7,757 | 7,477 | 31,832 |
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 dept to Piir och
Partner AB regarding these services that amounted to MSEK 0.2 (0). There were no other receivables or liabilities.
Up until first quarter this year, no items affecting comparability have 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.
| KSEK | Note | 2016 Jan – Mar |
2015 Jan – Mar |
2015 Jan - Dec |
|---|---|---|---|---|
| Revenues | 3 | 20 246 | 58 568 | 154 799 |
| Cost of goods sold | -63 | -28 | -237 | |
| Gross profit | 20 183 | 58 540 | 154 562 | |
| Marketing and distribution costs | -4 298 | -2 930 | -31 338 | |
| Administrative expenses | -3 715 | -5 641 | -74 790 | |
| Research and development costs | -35 394 | -37 368 | -251 937 | |
| Other operating income | 16 | 506 | 57 | |
| Other operating expenses | -1 650 | 0 | -658 | |
| Operating result | 6 | -24 857 | 13 106 | -204 104 |
| Result from financial items | ||||
| Finance income | 2 | 0 | 2 | |
| Finance expenses | -37 | -8 | -166 | |
| Net financial items | -35 | -8 | -164 | |
| Result before tax | -24 893 | 13 098 | -204 268 | |
| Income tax | 9 | 5 476 | -2 882 | 44 727 |
| Result for the period | -19 416 | 10 217 | -159 542 |
Adjustment for non-cash items:
| KSEK | 2016 Jan – Mar |
2015 Jan – Mar |
2015 Jan - Dec |
|---|---|---|---|
| Depreciation | 840 | 849 | 3 552 |
| Costs of share bonus program | - | - | 108 793 |
| Total | 840 | 849 | 112 345 |
Tax for the period amounted to MSEK 5.5 (-2.9), primarily attributable to the negative result for the period. The difference compared to the year earlier period is that the company reported a profit at that time.
The change in equity for the first quarter is attributable to the loss for the period.
The information in this report comprises the information that Camurus is obliged to disclose under the provisions of the Swedish Securities Markets Act. This information was released for publication at 07.00 AM CET on 17 May 2016.
________________________________________________
CAMURUS INTERIM REPORT FIRST QUARTER 2016 23
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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