Annual Report • Feb 15, 2018
Annual Report
Open in ViewerOpens in native device viewer
FULL YEAR REPORT 2017
| Annual Report 2017 | 22 March 2018 |
|---|---|
| Q1 2018 | 3 May 2018, 13.00 |
| Annual General Meeting 2018 | 3 May 2018 |
| Q2 2018 | 17 July 2018 |
| Q3 2018 | 25 October 2018 |
"We are fully dedicated to achieving approvals for CAM2038 in Europe, Australia and the US during 2018, and the launch preparations for this much-needed treatment of opioid dependence are progressing according to plan."
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.
Highlights from the last quarter of 2017 include the FDA Advisory Committee recommendation for approval of CAM2038 for opioid dependence and the start of a new clinical program for treatment of pulmonary arterial hypertension.
Listening to the testimonies of patients that participated in our clinical studies of CAM2038 was a touching experience for me at the Advisory Committee meeting. Their stories of how CAM2038 had contributed to their recovery, and improved their self-esteem, without the stigma and disease reminders associated with daily sublingual medication, was a firm acknowledgement that we have developed a treatment with the potential to significantly improve lives. The positive response from so many patients and study investigators spurs us in our quest to make CAM2038 available on the market as quickly as possible.
During the final quarter of 2017 we were delighted to receive a positive FDA Advisory Committee recommendation for CAM2038. However, on the 19 January 2018, Braeburn Pharmaceuticals, our US partner for CAM2038, received a complete response letter from the FDA, requiring further information to the New Drug Application (NDA) for CAM2038. No additional clinical studies are required, and we are working with Braeburn to address the FDA's questions. While the complete response letter for CAM2038 was unexpected and disappointing, we do not believe this delay will significantly impact the future market potential for CAM2038.
Approval of CAM2038 in other markets progressed according to plan. The CAM2038 market approval application (MAA) submitted to the Australian Therapeutic Goods Administration (TGA) was accepted for review and is being processed alongside the European MAA. An opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use is expected in Q3 2018, and final approval decisions from both the EMA and TGA are anticipated in Q4 2018.
In preparation for the commercial launch of CAM2038, we are continuing to add experts to our regional teams in the UK, Germany, France, and the Nordics. In parallel, we are engaging with key opinion leaders and payors to demonstrate the value CAM2038 will bring to health economies and the wider society.
During Q4, Phase 3 results from our comprehensive clinical study program for CAM2038 for opioid dependence were presented by our study investigators at several leading international addiction conferences and regional meetings: ISAM Annual Meeting in Abu Dhabi, AAAP in San Diego, APSAD in Melbourne, ATHS in Biarritz, and SSA in Newcastle.
Aside from scientific and regulatory progress in the opioid dependence area, we also made progress with other important programs in Q4:
PAH is a rare and severe chronic disease of the heart and lungs. The current PAH market exceeds USD 5 billion globally, of which almost one quarter is treprostinil sales. A weekly subcutaneous depot could provide important patient benefits compared to current infusion products, which are associated with risks of serious infections, severe infusion site pain and which require a complex extracorporeal pump system.
Looking ahead, we can expect an exciting year as we and our partners continue to move our clinical pipeline forward. We are fully dedicated to achieving approvals for CAM2038 in Europe, Australia and the US during 2018, and the launch preparations for this much-needed treatment for opioid dependence are progressing according to plan. We are also anticipating positive Phase 3 results for a second indication of chronic pain, which, like opioid dependence, is an area with high unmet medical needs and significant market potential. In addition, results from several of our other clinical programs and collaborations are expected during the year, with the potential for further value creation and company growth.
Fredrik Tiberg, President & CEO
• Braeburn Pharmaceuticals received a complete response letter from the FDA, requiring additional information to the new drug application (NDA) for CAM2038
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 project is given below.
| PARTNER | PRODUCT | PRE-CLINICAL | PHASE 1-2 | PHASE 3 | REGISTRATIO |
|---|---|---|---|---|---|
| camurus. b braeburn | CAM2038 q1w OPIOID DEPENDENCE | REGISTRATION | |||
| camurus. b braeburn | CAM2038 q4w OPIOID DEPENDENCE | REGISTRATION | |||
| camurus. b braeburn | CAM2038 q1w CHRONIC PAIN | PHASE3 | |||
| camurus. b braeburn | CAM2038 q4w CHRONIC PAIN | PHASE3 | |||
| NOVARTIS | CAM2029 NEUROENDOCRINE TUMORS | PHASE 1-2 | |||
| NOVARTIS | CAM2029 ACROMEGALY | PHASE 1-2 | |||
| camurus. | CAM2032 PROSTATE CANCER | PHASE 1-2 | |||
| camurus. | CAM2047 CINV 1 | PHASE 1-2 | |||
| camurus. b braeburn | CAM2048/58 POSTOPERATIVE PAIN & PONV2 | PHASE 1-2 | |||
| $r$ hýthm | CAM4072 GENETIC OBESITY | PHASE 1-2 | |||
| NOVARTIS | CAM4071 UNDISCLOSED INDICATION | PHASE 1-2 | |||
| camurus. | CAM2043 PAH3 | PHASE 1-2 |
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.
A New Drug Application (NDA) for CAM2038 in opioid use disorder was submitted by our partner Braeburn Pharmaceuticals to the US Food and Drug Administration (FDA) during Q3 2017. Later in Q3, the FDA informed that they accepted the NDA and granted a Priority Review with a PDUFA date set for 19 January 2018. In parallel, during Q3 2017, a Marketing Authorization Application (MAA) was submitted and validated by the European Medicines Agency (EMA). In Q4 2017, an MAA to the Australian authority, Therapeutic Goods Administration (TGA), was
accepted for evaluation. These submissions were supported by a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. A core component of the submissions was the positive results from a randomized, double-blind, doubledummy study of weekly and monthly CAM2038 depot injections versus daily treatment with sublingual buprenorphine/naloxone in 428 adult patients with opioid use disorder. The study met both the FDA and EMA primary endpoints for responder rate and mean percent of urines samples negative for illicit opioids. Superiority 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.
On November 1, the FDA Advisory Committee for Psychopharmacologic Drugs and Drug Safety and Risk Management voted 17-3 recommending approval of CAM2038. After the period, in January 2018 the FDA issued a complete response letter (CRL) for the CAM2038 NDA requesting additional information to complete the review. The request, issued to Camurus' partner Braeburn Pharmaceuticals, did not request new clinical studies and the Agency's requests will be addressed in a timely manner.
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.
The Phase 3 efficacy study of CAM2038 in chronic lowerback pain is being completed and we have initiated a longterm safety extension study. Recruitment was completed during the quarter. Topline results from the efficacy study are expected in Q2 2018, followed by long-term 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 Sandostatine® LAR® by means of higher bioavailability, fast onset of effect, and improved dosing; a prefilled syringe with a thin needle. CAM2029 has been evaluated in four clinical Phase 1/2 studies and demonstrated positive results in a Phase 2 multicenter study in patients with acromegaly and neuroendocrine tumours. CAM2029 is being developed by Novartis under licence from Camurus.
Our collaboration with Novartis is continuing with full force and we plan in mid-2018 to communicate updated project time-lines for the start of the Phase 3 program.
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 regional development and commercialization partners are currently 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 with regard to release of the active substance, stability, and as well as pharmacological and toxicological properties defined by the target product profiles.
CAM4071 is a product candidate in clinical development under an option, collaboration and licensing agreement with Novartis. The product candidate is a long-acting formulation of an undisclosed peptide and based on the FluidCrystal® Injection depot. A Phase 1 trial of pharmacokinetics and pharmacodynamics, performed together with Novartis, has been completed and reported.
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 was completed in Q3 2017. Results from the study demonstrated that all products were well tolerated locally and systemically, with pharmacokinetic profiles meeting the target specifications for these product candidates. Next steps comprise in depth analysis of clinical registration programs and market potentials of the different product candidates.
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 the first cohort of healthy volunteers was treated in a dose escalating Phase 1 study with CAM2043. Interim results from the study are expected in Q2 2018, and final results are anticipated in Q3 2018.
Setmelanotide is a novel melanocortin-4 receptor agonist (MC4R) for treatment of genetic obesity. The FDA granted Rhythm's setmelanotide Breakthrough Therapy designation for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LepR) deficiency obesity. 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, which has demonstrated positive pharmacokinetic and pharmacodynamic results in preclinical studies. Statistically significant decreases in body weight as well as food intake have also been demonstrated.
Following the completion of a single-dose study, Rhythm recently completed a multi-dose clinical Phase 1 study evaluating the long-acting, once-weekly formulation of setmelanotide, CAM4072. The study demonstrated tolerability and pharmacokinetics that support further clinical development. According to Rhythm, a NDA could be ready for submission at earliest in 2019.
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. episil® received marketing approval in Japan by the Japanese Ministry of Health, Labour and Welfare in June 2018. Reimbursement and pricing was recently announced by Solasia.
Revenues during the quarter amounted to MSEK 5.5 (37.1), 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.
According to plan, the main cost drivers are the completion of the comprehensive pivotal clinical program of CAM2038 in opioid dependence, the continuous development of the early project pipeline and the expansion of the commercial organization in preparation of the planned launch of CAM2038 in Europe.
Marketing, business development and distribution costs during the quarter, were MSEK 11.3 (9.4).
Administrative expenses amounted to MSEK 11.1 (4.1).
R&D costs, including depreciation and amortization of tangible and intangible assets were MSEK 48.1 (59.0).
Other operating expenses, which mainly consist of currency exchange losses in operational activities, were MSEK -0.2 (1.4).
The operating result for the quarter was MSEK -66.1 (-35.1).
Financial items for the period was MSEK 0.0 (-0.0). Tax was MSEK 13.8 (7.4) and is mainly attributable to deferred tax losses during the quarter.
The result for the period was MSEK -52.2 (-27.8), corresponding to earnings per share of SEK -1.40 (-0.75) before and after dilution.
Cash flow from operating activities, before change in working capital, was negative and amounted to MSEK -65.0 (-34.3).
Change in working capital affected the cash flow by MSEK 10.0 (26.7).
Cash flow from investing activities was MSEK -0.6 (-2.7) and from the financing activities MSEK 0.3 (0.7) related to issuance of warrants.
The company's cash position as of December 31, 2017, was MSEK 314.5 (508.6). The difference compared to the previous year is mainly attributable to the operating result.
There were no outstanding loans as of December 31, 2017, and no loans have been taken up since.
Consolidated equity as of December 31, 2017, was MSEK 385.0 (564.4)
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, TO2017/2020, 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. Transfer of subscription warrants to future employees may not occur after the Annual General Meeting 2017. As per December 31, 2016, 47 employees had chosen to participate in TO2016/2019 and subscribed for 404,300 warrants. No further warrants have been subscribed for thereafter. During the year, earnings after tax were negatively impacted by MSEK 1.7 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, 658,932 warrants had been subscribed for and equity increased with MSEK 11.1. Earnings after tax were negatively impacted by MSEK 5.4 related to the stay-on bonus the participants receive as part of the program.
On the 19th of January, our partner Braeburn Pharmaceuticals received a complete response letter from the US Food and Drug Administration (FDA), requiring additional information to the new drug application (NDA) for CAM2038. No additional clinical studies are required.
Revenues for the quarter amounted to MSEK 10.6 (37.1) and the result after tax was MSEK -62.6 (-28.4).
On December 31, 2017, equity in the Parent Company amounted to MSEK 367.7 (547.1).
Total assets at the end of the period was MSEK 460.1 (626.5) of which MSEK 309.8 (508.6) were cash and cash equivalents.
At the end of the period, Camurus had 71 (62) employees, of whom 48 (44) were within research and development. The full time equivalent employees (FTEs) during the quarter amounted to 64 (56).
As we entered 2018, a minor structural change of the company's executive management group was implemented.
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 interim report for the third quarter 2017.
This report has not been reviewed by the company's auditors.
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.
In accordance with the dividend policy adopted by the Board, no dividend is proposed for the financial year 2017.
The Annual Report for 2017 will be published on the company's website, camurus.com on March 22, 2018. It will also be available from Camurus AB's headquarters in Lund.
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, February 14, 2018 Camurus AB Board of Directors
CAMURUS FULL YEAR REPORT 2017 10
| 2017 | 2016 | 2017 | 2016 | ||
|---|---|---|---|---|---|
| KSEK | Note | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| Net sales | 3 | 5,458 | 37,126 | 54,308 | 113,737 |
| Cost of goods sold | -754 | -1,229 | -1,356 | -2,140 | |
| Gross profit | 4,704 | 35,897 | 52,952 | 111,597 | |
| Marketing and distribution costs | -11,347 | -9,385 | -45,893 | -24,738 | |
| Administrative expenses | -11,055 | -4,067 | -26,590 | -17,985 | |
| Research and development costs | -48,142 | -59,017 | -222,939 | -172,077 | |
| Other operating income | 34 | 1,436 | 93 | 751 | |
| Other operating expenses | -269 | - | -1,147 | - | |
| Operating result | -66,075 | -35,136 | -243,524 | -102,452 | |
| Finance income | 51 | 87 | 174 | 95 | |
| Finance expenses | -3 | -128 | -18 | -1,002 | |
| Net financial items | 48 | -41 | 156 | -907 | |
| Result before tax | -66,026 | -35,178 | -243,368 | -103,359 | |
| Income tax | 8 | 13,836 | 7,367 | 52,794 | 22,367 |
| Result for the period | 4 | -52,190 | -27,811 | -190,574 | -80,993 |
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 | 2017 Oct-Dec |
2016 Oct-Dec |
2017 Jan-Dec |
2016 Jan-Dec |
|---|---|---|---|---|
| Earnings per share before dilution, SEK |
-1.40 | -0.75 | -5.11 | -2.17 |
| Earnings per share after dilution, SEK | -1.40 | -0.75 | -5.11 | -2.17 |
Presently, the company has two subscription warrant programs active. For further information see page 8, Camurus' share and page 20.
Total current assets 334,382 549,592 TOTAL ASSETS 475,934 639,776
| KSEK | Note | 31-12-2017 | 31-12-2016 | KSEK Note |
31-12-2017 | 31-12-2016 |
|---|---|---|---|---|---|---|
| ASSETS | EQUITY | |||||
| Fixed assets | ||||||
| Equity attributable to parent company | ||||||
| Intangible assets | shareholder | |||||
| Capitalized development expenditure | 16,653 | 18,741 | Share capital | 932 932 |
||
| Other contributed capital | 642,175 | 631,034 | ||||
| Tangible assets | Retained earnings, including results for the period | -258,107 | -67,549 | |||
| Equipment | 9,902 | 9,759 | Total equity | 9 385,000 |
564,418 | |
| Financial assets | LIABILITIES | |||||
| Deferred tax receivables | 8 | 114,997 | 61,685 | |||
| Total fixed assets | 141,552 | 90,185 | Short-term liabilities | |||
| Trade payables | 15,086 | 17,560 | ||||
| Current assetts | Income taxes | 517 - |
||||
| Other liabilities | 2,672 | 2,571 | ||||
| Inventories | Accrued expenses and deferred income | 72,659 | 55,228 | |||
| Finished goods | 724 | 300 | Total short-term liabilities | 90,934 | 73,358 | |
| Raw materials | 2,829 | 12,080 | TOTAL EQUITY AND LIABILITIES | 475,934 | 639,776 | |
| Current receivables | ||||||
| Trade receivables | 5,781 | 8,304 | ||||
| Other receivables | 3,285 | 3,855 | ||||
| Prepayments and accrued income | 7,239 | 16,459 | ||||
| Total current receivables | 5 | 16,305 | 28,618 | |||
| Cash and cash equivalents | 314,524 | 508,594 |
| Other | Retained earnings, |
||||
|---|---|---|---|---|---|
| KSEK | Note | Share capital | contributed capital |
including result for the period |
Total equity |
| 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 | 932 | 631,034 | -67,549 | 564,418 | |
| 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 |
9 | 932 | 642,175 | -258,107 | 385,000 |
| KSEK Note |
2017 Oct-Dec |
2016 Oct-Dec |
2017 Jan-Dec |
2016 Jan-Dec |
|---|---|---|---|---|
| Operating activities | ||||
| Operating result before financial items |
-66,083 | -35,136 | -243,524 | -102,452 |
| Adjustment for non-cash items 7 |
1,042 | 845 | 4,104 | 3,524 |
| Interest received | 51 | 87 | 174 | 95 |
| Interest paid | -3 | -128 | -18 | -1,002 |
| Income taxes paid | 0 | 0 | 0 | -9,917 |
| -64,993 | -34,332 | -239,264 | -109,752 | |
| Increase/decrease in inventories | -439 | -8,423 | 8,827 | -9,139 |
| Increase/decrease in trade receivables | 1,981 | 9,104 | 2,523 | 613 |
| Increase/decrease in other current receivables | 1,268 | 8,095 | 9,788 | 1,005 |
| Increase/decrease in trade payables | -2,697 | 9,728 | -2,474 | -14,272 |
| Increase/decrease in other current operating liabilities | 9,928 | 8,167 | 17,532 | -76,243 |
| Cash flow from changes in working capital | 10,041 | 26,672 | 36,196 | -98,036 |
| Cash flow from operating activities | -54,952 | -7,660 | -203,068 | -207,788 |
| Investing activities | ||||
| Acquisition of tangible assets | -607 | -2,712 | -2,143 | -4,567 |
| Cash flow from investing activities | -607 | -2,712 | -2,143 | -4,567 |
| Financing activities | ||||
| Warrants issued | 335 | 718 | 11,141 | 4,853 |
| Cash flow from financing activities | 335 | 718 | 11,141 | 4,853 |
| Net cash flow for the period | -55,224 | -9,654 | -194,070 | -207,502 |
| Cash and cash equivalents at beginning of period | 369,748 | 518,248 | 508,594 | 716,096 |
| Cash and cash equivalents at the end of period | 314,524 | 508,594 | 314,524 | 508,594 |
| KSEK Note |
2017 Oct-Dec |
2016 Oct-Dec |
2017 Jan-Dec |
2016 Jan-Dec |
|---|---|---|---|---|
| Net sales1) | 10,552 | 37,126 | 64,640 | 113,737 |
| Cost of goods sold |
-754 | -1,229 | -1,356 | -2,140 |
| Gross profit | 9,798 | 35,897 | 63,284 | 111,597 |
| Marketing and distribution costs | -9,602 | -9,385 | -30,234 | -24,738 |
| Administrative expenses2) | -18,164 | -4,067 | -54,689 | -17,985 |
| Research and development costs | -47,618 | -58,497 | -220,849 | -169,994 |
| Other operating income | -343 | 1,436 | 61 | 751 |
| Other operating expenses | -276 | - | -1,147 | - |
| Operating result |
-66,205 | -34,615 | -243,574 | -100,370 |
| Interest income and similar items | 51 | 87 | 174 | 95 |
| Interest expense and similar items | -3 | -128 | -18 | -1,002 |
| Result after financial items | -66,157 | -34,657 | -243,418 | -101,277 |
| Appropriations | 0 | -1,246 | 0 | -1,246 |
| Result before tax | -66,157 | -35,903 | -243,418 | -102,523 |
| Tax on profit for the period 8 |
13,855 | 7,526 | 52,853 | 22,183 |
| Result for the period | -52,302 | -28,377 | -190,565 | -80,340 |
1) In the fourth quarter the group internal sales have been reclassified from Other operating income to Net sales.
2) 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 | 31-12-2017 | 31-12-2016 | KSEK | Note | 31-12-2017 | 31-12-2016 |
|---|---|---|---|---|---|---|---|
| ASSETS | EQUITY AND LIABILITES | ||||||
| Fixed assets | Restricted equity | ||||||
| Restricted equity (37 281 486 shares) | 932 | 932 | |||||
| Tangible fixed assets | Statutory reserve | 11,327 | 11,327 | ||||
| Equipment | 9,725 | 9,759 | Total restricted equity | 12,259 | 12,259 | ||
| Financial fixed assets | Unrestricted equity | ||||||
| Interest in Group companies | 1,545 | 816 | Retained earnings | -62,594 | 17,746 | ||
| Deferred tax assets | 8 | 119,426 | 66,574 | Share premium reserve | 608,560 | 597,418 | |
| Total fixed assets | 130,696 | 77,149 | Result for the period | -190,565 | -80,340 | ||
| Total unrestricted equity | 355,401 | 534,823 | |||||
| Current assets | TOTAL EQUITY | 367,660 | 547,083 | ||||
| Inventories | LIABILITIES | ||||||
| Finished goods | 724 | 300 | Untaxed reserves | ||||
| Raw materials | 2,829 | 12,080 | Depreciation/amortization in excess of plan |
3,486 | 3,486 | ||
| Total untaxed reserves | 3 486 | 3,486 | |||||
| Current receivables | |||||||
| Trade receivables | 5,781 | 8,304 | Long-term liabilities | ||||
| Other receivables | 3,040 | 3,855 | Liability to subsidiaries | 571 | 573 | ||
| Prepayments and accrued income | 7,202 | 16,459 | Total long-term liabilities | 571 | 573 | ||
| Total current receivables | 16,022 | 28,618 | |||||
| Short-term liabilities | |||||||
| Cash and bank deposits | 309,821 | 508,351 | Liabilities to Group companies | 3,769 | - | ||
| Total current assets | 329,397 | 549,351 | Trade payables | 14,431 | 17,560 | ||
| TOTAL ASSETS | 460,093 | 626,499 | Other liabilities | 2,053 | 2,571 | ||
| Accrued expenses and deferred income | 68,123 | 55,227 | |||||
| Total short-term liabilities | 88,376 | 75,358 |
TOTAL EQUITY AND LIABILITY 460,093 626,499
| MSEK | 2017 Oct-Dec |
2016 Oct-Dec |
2017 Jan-Dec |
2016 Jan-Dec |
|---|---|---|---|---|
| Net revenues | 5.5 | 37.1 | 54.3 | 113.7 |
| Operating result | -66.1 | -35.1 | -243.5 | -102.5 |
| Result for the period | -52.2 | -27.8 | -190.6 | -81.0 |
| Cash flow from operating activities | -55.0 | -7.7 | -203.1 | -207.8 |
| Cash and cash equivalents | 314.5 | 508.6 | 314.5 | 508.6 |
| Equity | 385.0 | 564.4 | 385.0 | 564.4 |
| Equity ratio in Group, percent | 81% | 88% | 81% | 88% |
| Total assets | 475.9 | 639.8 | 475.9 | 639.8 |
| Average number of shares, before dilution | 37,281,486 | 37,281,486 | 37,281,486 | 37,281,486 |
| Average number of shares, after dilution*) | 38,344,718 | 37,667,121 | 38,058,298 | 37,487,937 |
| Earnings per share before dilution, SEK | -1.40 | -0.75 | -5.11 | -2.17 |
| Earnings per share after dilution, SEK*) | -1.40 | -0.75 | -5.11 | -2.17 |
| Equity per share before dilution, SEK | 10.33 | 15.14 | 10.33 | 15.14 |
| Equity per share after dilution, SEK*) | 10.04 | 14.98 | 10.12 | 15.06 |
| Number of employees at the end of period | 71 | 62 | 71 | 62 |
| Number of employees in R&D at the end of period |
48 | 44 | 48 | 44 |
| R&D costs as a percentage of operating expenses | 68% | 81% | 75% | 80% |
*) The dilution effect is calculated according to IAS 33
Cash and cash equivalent
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 fourth quarter 2017 was approved for publication in accordance with a decision by the Board of Directors on February 14, 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. No revised assessment regarding the impact from the coming IFRS standards, IFRS 15 and IFRS 9, has been made, i.e. the assessment that the standards will not have significant impact remains.
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 stay-on 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 Warrant program TO2016/2019
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 | 2017 Oct-Dec |
2016 Oct-Dec |
2017 Jan-Dec |
2016 Jan-Dec |
|---|---|---|---|---|
| Sales of development related goods and services | 4,728 | 21,366 | 41,394 | 68,112 |
| Milestone payments | 0 | 14,699 | 7,025 | 34,217 |
| Licensing revenues | 387 | 60 | 3,582 | 8,485 |
| Other | 343 | 1,001 | 2,307 | 2,923 |
| Total | 5,458 | 37,126 | 54,308 | 113,737 |
Revenues from external customers are allocated by country, based on where the customers are located.
| KSEK | 2017 Oct-Dec |
2016 Oct-Dec |
2017 Jan-Dec |
2016 Jan-Dec |
|---|---|---|---|---|
| Europe | 256 | 2,127 | 7,229 | 22,921 |
| (of which Sweden) | (55) | (67) | (239) | (3,727) |
| North America | 5,202 | 34,362 | 41,350 | 87,359 |
| Other geographical areas | 0 | 637 | 5,729 | 3,457 |
| Total | 5,458 | 37,126 | 54,308 | 113,737 |
Revenues during the quarter of approximately MSEK 5,0 (50,9) relate 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 | 2017 Oct-Dec |
2016 Oct-Dec |
2017 Jan-Dec |
2016 Jan-Dec |
|---|---|---|---|---|
| Result attributable to parent company shareholders | -52,190 | -27,811 | -190,574 | -80,993 |
| Total | -52,190 | -27,811 | -190,574 | -80,993 |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 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 | 2017 Oct-Dec |
2016 Oct-Dec |
2017 Jan-Dec |
2016 Jan-Dec |
|---|---|---|---|---|
| Result attributable to parent company shareholders | -52,190 | -27,811 | -190,574 | -80,993 |
| Total | -52,190 | -27,811 | -190,574 | -80,993 |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 37,281 | 37,281 | 37,281 |
| Adjustments: | ||||
| - Warrants (thousands) |
1,064 | 386 | 777 | 207 |
| - Share issues (thousands) |
- | - | - | - |
| Weighted average number of ordinary shares in calculation of earnings per share after dilution (thousands) |
38,345 | 37,667 | 38,058 | 37,488 |
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.
Investor relations services have been acquired from Piir & Partners AB, whose representative was a member of the management team. Pricing is done in accordance with market terms and costs are expensed in relation to utilization rate. During the period the company has purchased services from Piir & Partner AB to a value of MSEK 0,1 (0,3). At the end of the period the company had a debt to Piir & Partner AB regarding these services that amounted to MSEK 0,0 (0,3). No other receivables or liabilities existed.
| Carrying amount, KSEK | 31-12-2017 | 31-12-2016 |
|---|---|---|
| Loans and receivables | ||
| Trade receivables | 5,781 | 8,304 |
| Receivables from Group companies | - | - |
| Other receivables | - | - |
| Cash and cash equivalents | 314,524 | 508,594 |
| Total | 320,305 | 516,898 |
| Other liabilities | ||
| Other financial liabilities | - | - |
| Liabilities to Group companies | - | - |
| Trade payables | 15,086 | 17,560 |
| Other current liabilities | 191 | 191 |
| Total | 15,277 | 17,751 |
Adjustment for non-cash items:
Tax for the quarter amounted to MSEK 13.8 (7.4), primary attributable to the negative result.
The change in equity for the quarter is mainly attributable to the loss.
| 2017 | 2016 | 2017 | 2016 | |
|---|---|---|---|---|
| KSEK | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| Depreciation | 1,037 | 845 | 4,088 | 3,524 |
| Exchange-rate differences | 5 | - | 16 | - |
| Total | 1,042 | 845 | 4,104 | 3,524 |
CAMURUS AB | Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 | F +46 46 286 57 39 | [email protected] | camurus.com
CAMURUS FULL YEAR REPORT 2017 24
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.