Quarterly Report • May 3, 2018
Quarterly Report
Open in ViewerOpens in native device viewer
INTERIM REPORT 2018 Q1
3 CEO statement
| Annual General Meeting 2018 |
3 May 2018 |
|---|---|
| Q2 2018 | 17 July 2018 |
| Q3 2018 | 25 October 2018 |
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® technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company's share is listed on Nasdaq Stockholm under the ticker "CAMX". For more information, visit camurus.com
"We are targeting marketing authorization approvals in all key markets in 2018"
During the first quarter of 2018, we worked intensely to address the questions raised by the FDA in the CRL issued for CAM2038 for the treatment of opioid dependence. A briefing package has been submitted to the Agency detailing key parts of the response strategy for the resubmission of the NDA. Meanwhile, the regulatory review processes for CAM2038 continued to progress in Europe and Australia, and we are targeting marketing authorization approvals in all key markets in 2018.
In January 2018, our partner Braeburn Pharmaceuticals received a complete response letter (CRL) from the US Food and Drug Administration (FDA), requesting additional information for the US marketing approval of our weekly and monthly buprenorphine depots, CAM2038, for the treatment of opioid dependence. The work to answer the Agencies questions started immediately and we expect resubmission of the new drug application (NDA) for CAM2038 in Q2 2018. In parallel, our own marketing authorization applications in Europe and Australia progressed, with anticipated approval decisions in the fourth quarter of 2018.
CAM2038 has the potential to be the first approved long-acting treatment for opioid dependence in Europe and Australia. Preparations for launch, including the establishment of regional commercial teams, continue in full force. The interest in CAM2038 among patients, prescribers, payors and authorities is very encouraging. In addition to the strong data already established in the pivotal clinical studies, we are currently advancing new innovative partnerships to further demonstrate the clinical and health economic value of CAM2038 in opioid dependence treatment.
During the first quarter of 2018, all subjects completed treatment in the randomized, controlled Phase 3 efficacy study of CAM2038 for the treatment of chronic lower back pain. Topline efficacy results from the study, which has an ongoing long-term safety extension for a broader patient population, are expected towards the end of the second quarter of 2018. Positive Phase 3 results will form the basis of the continued clinical development of CAM2048/58 for postoperative pain and nausea.
During the quarter, manufacturing preparations for Phase 3 development of CAM2029 progressed well. We received notice of allowance of new patents from the US and Australian patent offices, which can further strengthen and extend the patent protection of CAM2029 until 2032 or beyond. After the period, we announced that Camurus regains the global development and commercialization rights to CAM2029, and related assets, from Novartis. This represents an important business opportunity for Camurus, which is well aligned with our strategy of building a strong and profitable specialty pharmaceutical company.
After the completion of the initial studies of a weekly setmelanotide depot for treatment of genetic obesity disorders under development by our partner Rhythm, Camurus received notice that the first clinical milestone in the collaboration had been achieved.
Preparations for continued clinical studies in patients with rare genetic obesity disorders are ongoing.
At the end of 2017, Camurus started a clinical Phase 1 study of a promising new product candidate – a long-acting treprostinil depot, CAM2043, for the treatment of pulmonary arterial hypertension (PAH). The first single ascending dose part of the study is now completed, and repeated dosing has been initiated.
Topline pharmacokinetic and tolerability results from this study are expected in the second quarter of 2018. Further clinical development of CAM2043 is being prepared with the aim to start a pivotal registration program in 2019.
We continued to make good progress in our key development programs during the first quarter, and I anticipate a strong news flow during the remainder of the year, with results and highlights from our clinical studies, marketing authorization decisions, and potential launches of CAM2038 in key global markets.
Fredrik Tiberg, President & CEO
• Camurus regains worldwide development and commercialization rights to CAM2029 and related product candidates from Novartis
| MSEK | 2018 Jan-Mar |
2017 Jan-Mar |
|---|---|---|
| Net Sales | 14,6 | 17,2 |
| Operating result | -46,4 | -51,6 |
| Result after tax | -36,3 | -40,2 |
| Earnings per share SEK before and after dilution | -0,97 | -1,08 |
| Cash position | 266,6 | 463,8 |
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, such as 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 the treatment of cancer and the side effects of cancer treatment, endocrine diseases, pain and addiction. A summary and status update on the different projects is given below.
| PARTNER | PRODUCT | PRE-CLINICAL | PHASE 1-2 | PHASE3 | REGISTRATION | MARKET |
|---|---|---|---|---|---|---|
| camurus. b braeburn | CAM2038 q1w OPIOID DEPENDENCE | REGISTRATION | ||||
| camurus. b braeburn | CAM2038 q4w OPIOID DEPENDENCE | REGISTRATION | ||||
| camurus. b braeburn | CAM2038 q1w CHRONIC PAIN | PHASE 3 | ||||
| camurus. b braeburn | CAM2038 q4w CHRONIC PAIN | PHASE 3 | ||||
| NOVARTIS | CAM2029 NEUROENDOCRINE TUMORS | PHASE 1-2 | ||||
| NOVARTIS | CAM2029 ACROMEGALY | PHASE 1-2 | ||||
| camurus. | CAM2032 PROSTATE CANCER | PHASE 1-2 | ||||
| camurus. | CAM2047 CINV1 | PHASE 1-2 | ||||
| camurus. b braeburn | CAM2048/58 POSTOPERATIVE PAIN & PONV 2 | PHASE 1-2 | ||||
| rhýthm | CAM4072 GENETIC OBESITY | PHASE 1-2 | ||||
| NOVARTIS | CAM4071 UNDISCLOSED INDICATION | PHASE 1-2 | ||||
| camurus. | CAM2043 PAH3 | PHASE 1-2 | ||||
| 1) Chemotherapy induced nausea and vomiting, 2) Postoperative nausea and vomiting. 3) Pulmonary arterial hypertension. |
Opioid dependence is a serious, chronic, relapsing disease and a growing global health problem. Medication assisted treatment (MAT) with daily buprenorphine and methadone represents current standard of care and has been shown effective in reducing withdrawal and cravings, misuse and spreading of diseases. However, these treatments are also associated with limitations such as poor treatment adherence, misuse, medication diversion, and accidental pediatric exposure. CAM2038 includes two long-acting subcutaneous buprenorphine depots for the treatment of opioid dependence. The investigational products are based on Camurus' proprietary FluidCrystal® injection depot technology and are intended for either weekly or monthly subcutaneous administration by healthcare personnel using prefilled syringes, provided in multiple doses, to allow individualized treatment of patients with opioid dependence. In addition, patients being treated with CAM2038 are freed from the burden and stigma associated with the daily, often supervised, distribution and administration of current buprenorphine medications. Treatment with CAM2038 also has the potential to generate substantial savings for the healthcare system and society by reducing the costs of frequent supervised treatment, improving treatment compliance, and lowering diversion, misuse and abuse. CAM2038 has been studied in a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. A pivotal efficacy study met both the FDA and EMA primary efficacy endpoints (responder rate and mean percent of urines samples negative for illicit opioids). In addition, superiority of CAM2038 was demonstrated for the cumulative percentage of patients with no evidence of illicit opioid use during treatment weeks 4 to 24. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine except for mild-to-moderate injection-site adverse events.
A New Drug Application (NDA) to Pharmaceuticals to the US Food and Drug Administration (FDA) and Marketing Authorization Applications (MAAs) to European Medicines Agency (EMA) to Australian authority, Therapeutic Goods Administration (TGA) are being evaluated by respective Authority.
In January 2018 the FDA issued a complete response letter (CRL) for the CAM2038 NDA requesting additional information for completion their review. The request, issued to Camurus' partner Braeburn Pharmaceuticals, did not include any demand of additional clinical studies. All requests from FDA are being addressed and a Type A Meeting briefing package has been submitted detailing key parts of the response strategy for the resubmission of the CAM2038 NDA. Braeburn is expected to resubmit the NDA during Q2 2018. EMA and TGA MAA approval processes are ongoing and final approval decisions from both Authorities are anticipated in Q4 2018.
Chronic pain is a global health problem, and is causing deterioration in general health, reduced quality of life, decreased work capacity and dependence and misuse of strong opioids. CAM2038 is therefore being developed to provide round-the-clock pain relief, while decreasing the risk of respiratory depression and fatal overdoses associated with full µ-opioid agonists, such as morphine, oxycodone and fentanyl. The properties of CAM2038 are considered to conform the targeted properties for treatments of chronic pain, i.e. the combination of longlasting efficacious analgesia with a reduced risk of misuse, abuse and illicit diversion.
In the Phase 3 efficacy study of CAM2038 in chronic lower-back pain, all patients have been fully treated in the efficacy phase. In the following long-term safety extension study, all patients have been included and the study is continuing according to plans. Topline results from the efficacy study are expected in Q2 2018, followed by longterm safety results in Q4 2018.
CAM2029 is being developed for the treatment of acromegaly and neuroendocrine tumours (NET). CAM2029 is a ready-to-use, long-acting subcutaneous injection depot of the active substance octreotide formulated with Camurus' proprietary FluidCrystal® Injection depot technology. It provides several potential advantages compared to presently marketed product Sandostatin® LAR® by means of higher bioavailability, fast onset of effect, and potential for improved patient convenience. CAM2029 has been evaluated in four clinical Phase 1/2 studies and demonstrated positive results in a Phase 2 multicentre study in patients with acromegaly and neuroendocrine tumours.
During the quarter, we received notice of allowance from the US and Australian patent offices for new patents, which can further strengthen and extend the patent protection for CAM2029 until 2032 or beyond.
After the period, we announced that Camurus regains the global development and commercialization rights to CAM2029, and related assets, from Novartis. Camurus plans to start the pivotal clinical program for CAM2029 during the first half of 2019.
The well-established hormone therapies for prostate cancer, based on gonadotropin releasing hormone agonists such as leuprolide, aim to reduce testosterone levels and thereby impede the growth of cancer cells. CAM2032 is a long-acting subcutaneous leuprolide depot for the treatment of prostate cancer. Additional potential indications for CAM2032 include precocious puberty, and endometriosis. CAM2032 is based on Camurus' FluidCrystal® Injection depot technology for administration as a small dose volume with a prefilled syringe and is not requiring any reconstitution or temperature conditioning. Based on simplicity of its administration, CAM2032 is being developed for easy subcutaneous injections by patients themselves.
Discussions with potential development and commercialization partners are ongoing.
Several new product candidates, selected with support of market analyses, are being evaluated in pharmaceutical and pre-clinical studies. The projects comprise formulation optimization regarding release of the active substance, stability, as well as pharmacological and toxicological properties defined by the target product profiles.
CAM4071 is a product candidate in clinical development under the option, collaboration and licensing agreement between Camurus and Novartis. The product candidate is a long-acting formulation of pasireotide based on the FluidCrystal® Injection depot, which has been investigated in a completed Phase 1 trial. Results from the study will be presented in an upcoming scientific conference.
Three new investigational products based on Camurus' FluidCrystal® Injection depot, CAM2047, CAM2048 and CAM2058, are being developed for the treatment of chemotherapy induced nausea and vomiting (CAM2047), pain (CAM2048), and combined treatment of postoperative pain, nausea and vomiting (CAM2058).
A Phase 1 trial of CAM2047, CAM2048 and CAM2058 results demonstrated that all products were well tolerated locally and systemically, with pharmacokinetic profiles meeting the target specifications for these product candidates. Planning of the registration program and analysis of market potential of the product candidates are ongoing.
CAM2043 is a new long-acting subcutaneous treprostinil depot, based on Camurus' FluidCrystal® technology, and is being developed for treatment of pulmonary arterial hypertension (PAH). Recently completed preclinical data indicate that CAM2043 is well tolerated, without any significant or unexpected injection site observations, and provides dose proportional plasma exposure of treprostinil suitable for weekly dosing. During Q4 2017, an IND was approved by the FDA and all healthy volunteers have been treated with CAM2043 in the single ascending dose (SAD) Phase 1 study. Interim results from the SAD study are expected in Q2 2018, and final results are anticipated in Q3 2018. Meanwhile, a multiple ascending dose (MAD) study is being initiated in Q2 2018.
Part 1 of the Phase 1 study that was initiated in December 2017 and featured single ascending doses of CAM2043 is now completed. The study continues with repeated dose treatment and topline results from the study are expected towards the end of the second quarter of 2018. Further clinical development of CAM2043 is being prepared with the aim to start a pivotal registration study in 2019.
Setmelanotide is a novel melanocortin-4 receptor agonist (MC4R) for treatment of genetic obesity. The FDA has granted Rhythm's setmelanotide Breakthrough Therapy designation for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LepR) deficiency obesity and Orphan Designation for treatment Prader-Willis Syndrome. Results from Phase 2 clinical trials of setmelanotide demonstrated significant weight loss and substantial reductions in hunger for patients with POMC and LepR deficiency obesity. Rhythm recently initiated Phase 3 clinical trials for each of these indications. In parallel, a long-acting formulation of setmelanotide (CAM4072) is being developed, based on Camurus' FluidCrystal® technology.
During the quarter we received notice from our partner Rhythm Pharmaceuticals that the first clinical milestone regarding the development program of CAM4072 was achieved. The notice came following the successful completion of the Phase 1 studies of single and repeat doses of CAM4072. Continued clinical studies of CAM4072 in patients with rare genetic obesity disorders are currently being prepared.
episil® oral liquid is a medical device for the treatment of inflammatory and painful conditions in the oral cavity, currently being marketed in Europe, the US and other territories. The product provides fast pain relief and protection of sore and inflamed mucosal surfaces caused, for example, by oral mucositis, a common and serious side effect of cancer treatment. When in contact with the buccal membrane, episil® transforms into a thin protective layer of gel, offering effective pain relief for up to 8 hours. episil® oral liquid is based on Camurus' FluidCrystal® topical bioadhesive technology.
Preparations for launch of episil® in Japan are on-going in close collaboration between our partner Solasia Pharma and their distribution partner Meiji Seika. Reimbursement and pricing was announced by Solasia during the period.
Revenues during the quarter amounted to MSEK 14.6 (17.2), generated from license agreements, project activities and product sales.
The difference compared to the same period last year is mainly attributable to the variation in revenue streams between quarters. See also note 3.
Marketing, business development and distribution costs during the quarter, were MSEK 17.5 (7.1). The increase compared to the same period last year is mainly attributable to the expansion of the commercial organization in preparation of the planned launch of CAM2038 in Europe.
Administrative expenses amounted to MSEK 5.0 (7.4). The decrease compared to the same period last year relates mainly to that initial costs for establishing the commercial organization were included in administrative expenses during the first quarter 2017.
R&D costs, including depreciation and amortization of tangible and intangible assets were MSEK 37.5 (54.1). The decrease compared with the same period last year is primarily attributable to costs related to completing the pivotal clinical program for CAM2038 in opioid dependence.
Other operating expenses, which mainly consist of currency exchange losses in operational activities, were MSEK 0.5 (0.1).
The operating result for the quarter was MSEK -46.4 (-51.6).
Financial items for the period was MSEK 0.0 (-0.0). Tax was MSEK 10.1 (11.3) and is mainly attributable to deferred tax for the reported loss during the quarter.
The result for the period was MSEK -36.3 (-40.2), corresponding to earnings per share of SEK -0.97 (-1.08) before and after dilution.
Cash flow from operating activities, before change in working capital, was negative and amounted to MSEK -45.2 (-50.6).
Change in working capital affected the cash flow by MSEK -1.8 (7.0).
Cash flow from investing activities was MSEK -0.7 (-0.1).
The company's cash position as of March 31, 2018, was MSEK 266.6 (463.8). The difference compared to the previous year is mainly attributable to the operating result.
There were no outstanding loans as of March 31, 2018, and no loans have been taken up since.
Consolidated equity as of March 31, 2018, was MSEK 348.9 (524.2).
No acquisitions or divestments have occurred during the quarter.
Camurus' share is listed on Nasdaq Stockholm. At the end of the period, the total number of shares was 37,281,486 (37,281,486).
Camurus has two subscription warrant programs active for the company's employees.
In accordance with a decision by the Shareholder's General Meeting in May 2016, an incentive program, TO2016/2019, was introduced. 550 000 warrants were issued, which give the right to subscribe for an equal number of shares during the period May 15, 2019 – December 15, 2019. The dilution of a full utilization of the program corresponds to 1.5 % of the share capital and voting rights. 47 employees have joined the program and subscribed for 404,300 warrants. Transfer of subscription warrants to future employees was not allowed after the Annual General Meeting 2017. During the quarter, earnings after tax were negatively impacted by MSEK 0.4 related to the stay-on bonus the participants receive as part of the program.
In accordance with a decision by the Shareholder's General Meeting in May 2017, an incentive program, TO2017/2020, was introduced. 750,000 warrants were issued, which give the right to subscribe for an equal number of shares during the period May 15, 2020 – December 15, 2020. The dilution of a full utilization of the program corresponds to 2.0% of the share capital and voting rights. By end of December 2017, 44 employees had joined the program and subscribed for 658,932 warrants. No further warrants have been subscribed for thereafter. During the quarter, earnings after tax were negatively impacted by MSEK 0.8 related to the stay-on bonus the participants receive as part of the program.
Camurus regains worldwide development and commercialization rights to CAM2029 and related product candidates from Novartis.
Revenues for the quarter amounted to MSEK 17.3 (17.3) and the result after tax was MSEK -36.4 (-39.9).
On March 31, 2018, equity in the Parent Company amounted to MSEK 331.2 (507.1).
Total assets at the end of the period was MSEK 416.9 (584.6) of which MSEK 257.9 (463.6) were cash and cash equivalents.
At the end of the period, Camurus had 72 (66) employees, of whom 49 (47) were within research and development, 14 (9) within business development and marketing and sales, while 8 (7) were within administration. The full time equivalent employees (FTEs) during the quarter amounted to 65 (59).
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 effect-related risks that can arise in clinical trials, regulatory risks relating to nonapproval 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 current risks, since revenues and costs arise in different currencies, mainly SEK, EUR, GBP and USD.
The Board of Directors has not changed its outlook on future developments in relations to their outlook published in the annual report for 2017.
This report has not been reviewed by the company's auditors.
No acquisitions or divestments have occurred during the quarter.
Camurus Annual General Meeting 2018 will be held on Thursday May 3, at 17.00 CET, at Elite Hotel Ideon, Scheelevägen 27, Ideon Science Park, 223 63 Lund, Sweden.
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, Sweden, May 2, 2018 Camurus AB Board of Directors
CAMURUS INTERIM REPORT FIRST QUARTER 2018 10
| KSEK | Note | 2018 Jan-Mar |
2017 Jan-Mar |
2017 Jan-Dec |
|---|---|---|---|---|
| Net sales | 3 | 14,639 | 17,192 | 54,308 |
| Cost of goods sold | -1,547 | -32 | -1,356 | |
| Gross profit | 13,092 | 17,161 | 52,952 | |
| Marketing and distribution costs | -17,502 | -7,093 | -45,893 | |
| Administrative expenses | -4,999 | -7,412 | -26,590 | |
| Research and development costs | -37,502 | -54,143 | -222,939 | |
| Other operating income | 28 | - | 93 | |
| Other operating expenses | 454 | -101 | -1,147 | |
| Operating result | -46,429 | -51,588 | -243,524 | |
| Finance income | 40 | 1 | 174 | |
| Finance expenses | -7 | -3 | -18 | |
| Net financial items | 33 | -2 | 156 | |
| Result before tax | -46,396 | -51,590 | -243,368 | |
| Income tax | 8 | 10,127 | 11,343 | 52,794 |
| Result for the period | 4 | -36,269 | -40,247 | -190,574 |
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.
EARNINGS PER SHARE, based on earnings attributable to parent company shareholders for the period (in SEK per share)
| SEK | 2018 | 2017 | 2017 |
|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | |
| Earnings per share before dilution, SEK | -0.97 | -1.08 | -5.11 |
| Earnings per share after dilution, SEK | -0.97 | -1.08 | -5.11 |
Presently, the company has two subscription warrant programs active. For further information see page 8 Camurus' share, and page 21.
ASSETS 435,872 597,593 475,934
| KSEK | Note | 2018-03-31 | 2017-03-31 | 2017-12-31 | KSEK | Note | 2018-03-31 | 2017-03-31 | 2017-12-31 |
|---|---|---|---|---|---|---|---|---|---|
| ASSETS | EQUITY | ||||||||
| Fixed assets | |||||||||
| Equity attributable to parent company | |||||||||
| Intangible assets | shareholder | ||||||||
| Capitalized development expenditure |
16,128 | 18,219 | 16,653 | Share capital | 932 | 932 | 932 | ||
| Other contributed capital | 642,175 | 631,034 | 642,175 | ||||||
| Tangible assets | Retained earnings, including results for the period | -294,228 | -107,797 | -258,107 | |||||
| Equipment | 10,053 | 10,463 | 9,902 | Total equity | 9 | 348,879 | 524,170 | 385,000 | |
| Financial assets | LIABILITIES | ||||||||
| Deferred tax receivables | 8 | 125,296 | 73,027 | 114,997 | |||||
| Total fixed assets | 151,477 | 101,710 | 141,552 | Short-term liabilities | |||||
| Trade payables | 12,579 | 13,053 | 15,086 | ||||||
| Current assets | Income taxes | 718 | - | 517 | |||||
| Other liabilities | 7,059 | 6,225 | 2,672 | ||||||
| Inventories | Accrued expenses and deferred income | 66,637 | 54,145 | 72,659 | |||||
| Finished goods | 1,893 | 2,148 | 2,829 | Total short-term liabilities | 86,993 | 73,424 | 90,934 | ||
| Raw materials | 471 | 6,103 | 724 | TOTAL EQUITY AND LIABILITIES | 435,872 | 597,593 | 475,934 | ||
| Current receivables | |||||||||
| Trade receivables | 1,270 | 6,689 | 5,781 | ||||||
| Other receivables | 4,703 | 5,459 | 3,285 | ||||||
| Prepayments and accrued income | 9,425 | 11,681 | 7,239 | ||||||
| Total current receivables | 5 | 15,398 | 23,829 | 16,305 | |||||
| Cash and cash equivalents | |||||||||
| Total current assets | 266,633 | 463,804 | 314,524 | ||||||
| TOTAL ASSETS | 284,395 | 495,884 | 334,382 |
| Other | Retained earnings, |
||||
|---|---|---|---|---|---|
| Share | contributed | including result | |||
| KSEK | Note | capital | capital | for the period | Total equity |
| Opening balance 1 January 2017 | 932 | 631,034 | -67,549 | 564,418 | |
| Result for the period and comprehensive income | -40,248 | -40,248 | |||
| Exchange-rate differences | - | - | - | - | |
| Transactions with shareholders | |||||
| Warrants issued | - | - | - | - | |
| Closing balance 31 March 2017 | 932 | 631,034 | -107,797 | 524,170 | |
| Opening balance 1 January 2017 | 932 | 631,034 | -67,549 | 564,418 | |
| Result for the period and comprehensive income | -190,574 | -190,574 | |||
| Exchange-rate differences | - | - | 16 | 16 | |
| Transactions with shareholders | |||||
| Warrants issued |
- | 11,141 | - | 11,141 | |
| Closing balance 31 December 2017 | 932 | 642,175 | -258,107 | 385,000 | |
| Opening balance 1 January 2018 | 932 | 642,175 | -258,107 | 385,000 | |
| Result for the period and comprehensive income | -36,269 | -36,269 | |||
| Exchange-rate differences | - | - | 148 | 148 | |
| Transactions with shareholders | |||||
| Warrants issued | - | - | - | - | |
| Closing balance 31 March 2018 | 9 | 932 | 642,175 | -294,228 | 348,879 |
| KSEK | Note | 2018 Jan-Mar |
2017 Jan-Mar |
2017 Jan-Dec |
|---|---|---|---|---|
| Operating activities | ||||
| Operating result before financial items |
-46,429 | -51,588 | -243,524 | |
| Adjustment for non-cash items | 7 | 1,196 | 1,013 | 4,104 |
| Interest received | 40 | 1 | 174 | |
| Interest paid | -7 | -3 | -18 | |
| Income taxes paid | - | - | 0 | |
| -45,200 | -50,577 | -239,264 | ||
| Increase/decrease in inventories | 1,189 | 4,129 | 8,827 | |
| Increase/decrease in trade receivables | 4,511 | 1,616 | 2,523 | |
| Increase/decrease in other current receivables | -3,604 | 3,174 | 9,787 | |
| Increase/decrease in trade payables | -2,507 | -4,507 | -2,474 | |
| Increase/decrease in other current operating liabilities | -1,434 | 2,569 | 17,532 | |
| Cash flow from changes in working capital | -1,845 | 6,981 | 36,196 | |
| Cash flow from operating activities | -47,045 | -43,596 | -203,068 | |
| Investing activities | ||||
| Acquisition of tangible assets | -666 | -1,195 | -2,143 | |
| Cash flow from investing activities | -666 | -1,195 | -2,143 | |
| Financing activities | ||||
| Warrants issued | - | - | 11,141 | |
| Cash flow from financing activities | - | - | 11,141 | |
| Net cash flow for the period | -47,711 | -44,791 | -194,070 | |
| Cash and cash equivalents at beginning of period | 314,524 | 508,594 | 508,594 | |
| Translation difference in cash flow and liquid assets | -180 | - | - | |
| Cash and cash equivalents at the end of period | 266,633 | 463,804 | 314,524 |
| KSEK | Note | 2018 Jan-Mar |
2017 Jan-Mar |
2017 Jan-Dec |
|---|---|---|---|---|
| Net sales | 17,265 | 17,337 | 64,640 | |
| Cost of goods sold | -1,547 | -32 | -1,356 | |
| Gross profit | 15,718 | 17,305 | 63,284 | |
| Marketing and distribution costs | -10,273 | -7,232 | -30,234 | |
| Administrative expenses1) | -15,695 | -7,555 | -54,689 | |
| Research and development costs | -36,967 | -53,621 | -220,849 | |
| Other operating income | - | - | 61 | |
| Other operating expenses | 579 | -101 | -1,147 | |
| Operating result | -46,638 | -51,204 | -243,574 | |
| Interest income and similar items | 40 | 1 | 174 | |
| Interest expense and similar items | -7 | -3 | -18 | |
| Result after financial items | -46,605 | -51,206 | -243,418 | |
| Appropriations | - | - | - | |
| Result before tax | -46,605 | -51,206 | -243,418 | |
| Tax on profit for the period | 8 | 10,183 | 11,265 | 52,853 |
| Result for the period | -36,422 | -39,941 | -190,565 |
1) The increase in cost compared to previous year, is mainly related to group internal recharges.
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 | 2018-03-31 | 2017-03-31 | 2017-12-31 | KSEK | Note 2018-03-31 |
2017-03-31 | 2017-12-31 |
|---|---|---|---|---|---|---|---|---|
| ASSETS | EQUITY AND LIABILITES | |||||||
| Fixed assets | Restricted equity | |||||||
| Restricted equity (37 281 486 shares) | 932 | 932 | 932 | |||||
| Tangible fixed assets | Statutory reserve | 11,327 | 11,327 | 11,327 | ||||
| Equipment | 9,878 | 10,463 | 9,725 | Total restricted equity | 12,259 | 12,259 | 12,259 | |
| Financial fixed assets | Unrestricted equity | |||||||
| Interest in Group companies | 1,545 | 816 | 1,545 | Retained earnings | -253,159 | -62,594 | -62,594 | |
| Deferred tax assets | 8 | 129,610 | 77,839 | 119,426 | Share premium reserve | 608,560 | 597,418 | 608,560 |
| Total fixed assets | 141,033 | 89,118 | 130,696 | Result for the period | -36,422 | -39,941 | -190,565 | |
| Total unrestricted equity | 318,979 | 494,883 | 355,401 | |||||
| Current assets | TOTAL EQUITY | 331,238 | 507,142 | 367,660 | ||||
| Inventories | LIABILITIES | |||||||
| Finished goods | 1,893 | 2,148 | 2,829 | Untaxed reserves | ||||
| Raw materials | 471 | 6,103 | 724 | Depreciation/amortization in excess of plan | 3,486 | 3,486 | 3,486 | |
| Total untaxed reserves | 3,486 | 3,486 | 3,486 | |||||
| Current receivables | ||||||||
| Trade receivables | 1,270 | 6,689 | 5,781 | Long-term liabilities | ||||
| Other receivables | 5,244 | 5,244 | 3,040 | Liability to subsidiaries | 571 | 1,945 | 571 | |
| Prepayments and accrued income | 9,130 | 11,681 | 7,202 | Total long-term liabilities | 571 | 1,945 | 571 | |
| Total current receivables | 15,644 | 23,614 | 16,022 | |||||
| Short-term liabilities | ||||||||
| Cash and bank deposits | 257,850 | 463,566 | 309,821 | Liabilities to Group companies | 1,362 | - | 3,769 | |
| Total current assets | 275,858 | 495,431 | 329,397 | Trade payables | 12,372 | 13,053 | 14,431 | |
| TOTAL ASSETS | 416,890 | 584,549 | 460,093 | Other liabilities | 5,466 | 5,130 | 2,053 | |
| Accrued expenses and deferred income | 62,395 | 53,793 | 68,123 | |||||
| Total short-term liabilities | 81,595 | 71,976 | 88,376 |
TOTAL EQUITY AND LIABILITY 416,890 584,549 460,093
| MSEK | 2018 Jan-Mar |
2017 Jan-Mar |
2017 Jan-Dec |
|---|---|---|---|
| Net sales | 14.6 | 17.2 | 54.3 |
| Operating result | -46.3 | -51.6 | -243.5 |
| Result for the period | -36.3 | -40.2 | -190.6 |
| Cash flow from operating activities | -47.0 | -43.6 | -203.1 |
| Cash and cash equivalents | 266.6 | 463.8 | 314.5 |
| Equity | 348.9 | 524.2 | 385.0 |
| Equity ratio in Group, percent | 80% | 88% | 81% |
| Total assets | 435.9 | 597.6 | 475.9 |
| Average number of shares, before dilution | 37,281,486 | 37,281,486 | 37,281,486 |
| Average number of shares, after dilution*) | 38,344,718 | 37,685,786 | 38,058,298 |
| Earnings per share before dilution, SEK | -0.97 | -1.08 | -5.11 |
| Earnings per share after dilution, SEK*) | -0.97 | -1.08 | -5.11 |
| Equity per share before dilution, SEK | 9.36 | 14.06 | 10.33 |
| Equity per share after dilution, SEK*) | 9.10 | 13.91 | 10.12 |
| Number of employees at the end of period | 72 | 64 | 71 |
| Number of employees in R&D at the end of period | 49 | 47 | 48 |
| R&D costs as a percentage of operating expenses | 63% | 79% | 75% |
*) The dilution effect is calculated according to IAS 33
Cash and cash bank balances
Equity ratio, % Equity divided by total capital
Average number of shares, before dilution Weighted average number of shares before adjustment for dilution effect of net shares
Average number of shares, after dilution Weighted average number of shares adjustment for the dilution effect of new shares
Earnings per share before dilution, SEK Result divided by the weighted average number of shares outstanding before dilution
Earnings per share after dilution, SEK Result divided by the weighted average number of shares outstanding after dilution
Equity per share before dilution, SEK
Equity divided by the weighted number of shares at the end of the period before dilution
Equity divided by the weighted number of shares at the end of the period after dilution
Research and development costs divided by operating expenses (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. Camurus AB's registered office is based in Lund, Sweden, at Ideon Science Park, 223 70 Lund. Camurus AB Group's interim report for the first quarter 2018 was approved for publication in accordance with a decision by the Board of Directors on May 2, 2018.
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 Account 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 the 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 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 and are the same and are consistent with those used in the preparation of Annual Report 2016, see camurus.com/Investors/Financial Reports. The Group has begun its analysis of possible transition effects of IFRS 16, but these are still in the early stages. More information will be presented in future interim reports and annual reports for 2018. As previously stated, the transition to IFRS 15 and IFRS 9 has not had any impact.
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 interest 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.
Camurus has two long-term incentive programs active for the company's employees. The warrants are valued by an independent institute in accordance with Black&Scholes model and are acquired by the participants at market value. As part of the program, the participants receive a threepiece stay-on bonus from the company in form of gross salary additions equivalent to the amount paid by the participant for the subscription warrants. As the stayon bonus is conditional on continued employment, costs including social security fee, are based on how much has been earned, and are expensed over the vesting period. Expenses are recognized as personnel cost in the income statement
Maximum 550,000 warrants could be issued and the program was introduced in accordance with a decision by the Annual General Meeting in May 2016. Warrant program TO2017/2020
Maximum 750,000 warrants can be issued and the program was introduced in accordance with a decision by the Annual General Meeting in May 2017.
The highest executive decision maker is the function responsible for allocating resources and assessing the operating segments results. In the Group this function is identified as the CEO based on the information he manages. As the operations in the Group, i.e. the development of pharmaceutical products based on Camurus' technology platform, is organized as an integrated unit, with similar risks and opportunities for the products and services produced, the entire Group's business constitutes one operating segment. The operating segment is monitored in a manner consistent with the internal reporting provided to the chief operating decision maker. In the internal reporting to the CEO, only one segment is used.
To follow is a breakdown of revenues from all products and services.
| KSEK | 2018 Jan-Mar |
2017 Jan-Mar |
2017 Jan-Dec |
|---|---|---|---|
| Sales of development related goods and services | 3,831 | 13,927 | 41,394 |
| Milestone payments | 7,840 | 2,205 | 7,025 |
| Licensing revenues | - | 835 | 3,582 |
| Other | 2,968 | 225 | 2,307 |
| Total | 14,639 | 17,192 | 54,308 |
Revenues from external customers are allocated by country, based on where the customers are located.
| KSEK | 2018 Jan-Mars |
2017 Jan-Mars |
2017 Jan-Dec |
|---|---|---|---|
| Europe | 532 | 1,375 | 7,229 |
| (of which Sweden) | (121) | (59) | (239) |
| North America | 11,310 | 15,670 | 41,350 |
| Other geographical areas | 2,797 | 147 | 5,729 |
| Total | 14,639 | 17,192 | 54,308 |
Revenues during the quarter of approximately MSEK 8.4 (13.2) relate to one single external customer.
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 | 2018 Jan-Mar |
2017 Jan-Mar |
2017 Jan-Dec |
|---|---|---|---|
| Result attributable to parent company shareholders | -36,269 | -40,247 | -190,574 |
| Total | -36,269 | -40,247 | -190,574 |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 37,281 | 37,281 |
In order to calculate earnings per share after dilution, 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 are compared to the number of shares that would have been issued assuming the warrants are exercised.
| KSEK | 2018 Jan-Mar |
2017 Jan-Mar |
2017 Jan-Dec |
|---|---|---|---|
| Result attributable to parent company shareholders | -36,269 | -40,247 | -190,574 |
| Total | -36,269 | -40,247 | -190,574 |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 37,281 | 37,281 |
| Adjustments: | |||
| - Warrants (thousands) |
1,063 | 404 | 777 |
| - Share issues (thousands) |
- | - | - |
| Weighted average number of ordinary shares in calculation of earnings per share after dilution (thousands) |
38,344 | 37,688 | 38,058 |
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.
There were no related party transactions during the period.
No receivables or liabilities existed as of March 31, 2018.
| Carrying amount, KSEK | 2018-03-31 | 2017-03-31 | 2017-12-31 |
|---|---|---|---|
| Loans and receivables | |||
| Trade receivables | 1,270 | 6,689 | 5,781 |
| Receivables from Group companies | - | - | - |
| Other receivables | - | - | - |
| Cash and cash equivalents | 266,633 | 463,804 | 314,524 |
| Total | 267,903 | 470,493 | 320,305 |
| Other liabilities | |||
| Other financial liabilities | - | - | - |
| Liabilities to Group companies | - | - | - |
| Trade payables | 12,579 | 13,053 | 15,086 |
| Other current liabilities | 191 | 191 | 191 |
| Total | 12,770 | 13,244 | 15,277 |
Adjustment for non-cash items:
Tax for the quarter amounted to MSEK 10.1 (11.3), primary attributable to the negative result.
The change in equity for the quarter is mainly attributable to the loss.
| 2018 | 2017 | 2017 | |
|---|---|---|---|
| KSEK | Jan-Mar | Jan-Mar | Jan-Dec |
| Depreciation | 1,048 | 1,013 | 4,088 |
| Exchange-rate differences | 148 | - | 16 |
| Total | 1,196 | 1,013 | 4,104 |
CAMURUS AB | Ideon Science Park, SE-223 70 Lund, Sverige T +46 46 286 57 30 | F +46 46 286 57 39 | [email protected] | camurus.com
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.