Quarterly Report • May 3, 2017
Quarterly Report
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INTERIM REPORT 2017 Q1
| Annual General Meeting 3 |
May 2017 |
|---|---|
| Q2 2017 |
13 July 2017 |
| Q3 2017 |
26 October 2017 |
| Full Year Report 2017 |
15 February 2018 |
| Annual Report 2017 |
22 March 2018 |
"New top-line Phase 3 results support the longterm safety and efficacy of CAM2038 in patients with opioid dependence. After completing presubmission meetings with EMA and FDA, market approval applications for CAM2038 are now FINANCIAL CALENDAR being finalized."
Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company's share is listed on Nasdaq Stockholm under the ticker "CAMX". For more information, visit camurus.com
We had a busy and productive first quarter with five ongoing clinical trials and several studies under initiation.The last patients completed treatment in the Phase 3 long-term safety study of CAM2038, weekly and monthly buprenorphine depots. New top-line Phase 3 results support the long-term safety and efficacy of CAM2038 in patients with opioid dependence. Having concluded pre-submission meetings with EMA and FDA, market approval applications for CAM2038 are now being finalized.
During the first quarter, we completed treatment of all patients in the open-label, long-term safety Phase 3 study of our weekly and monthly depots of buprenorphine together with our US partner Braeburn Pharmaceuticals. 228 patients in Europe, the U.S. and Australia were randomized in the study. Topline results demonstrated that the CAM2038 weekly and monthly depots were well tolerated and provided continuous treatment effect across the 48-week treatment period. Study retention was high, with 71% of patients completing the 48-week study treatment period.
After positive pre-submission meetings with the regulatory authorities (EMA and FDA), we are together with Braeburn Pharmaceuticals finalizing our market marketing authorization application and new drug applications (MAA and NDA) for submissions in mid-2017. The preparations for our anticipated 2018 launch of CAM2038 in Europe is well on-track, with the aim to
provide patients rapid access to a new treatment alternative with the potential to improve both treatment outcomes and quality of life.
We are also working to expand the future indications for CAM2038 to treatment of chronic pain and expect to complete the ongoing pivotal Phase 3-study in patients with chronic low-back pain before the end of the year. During the period, a meeting was held with FDA regarding the product registration for chronic pain. There is a significant unmet medical need for new therapeutic options for treating chronic pain, highlighted by the current opioid crisis and issues of diversion, misuse, dependence and overdoses relating to the use of prescription opioids. CAM2038 may effectively address these problems and become an important treatment alternative, including for patients in need for higher doses of opioid analgesics and risks of dependence, and may also provide effective and long-acting pain relief.
In our collaboration with Novartis for our long-acting octreotide depot, CAM2029, for treatment of acromegaly and neuroendocrine tumours, GMP-manufacturing was performed during the period for Novartis' planned start of Phase 3 studies later this year. Results from our previous Phase 2 study of CAM2029 in acromegaly and NET patients were presented at two scientific conferences; ENETS 2017 in Barcelona and ENDO 2017 in Orlando.
In the early clinical pipeline, treatment of the last cohorts is ongoing in the Phase 1 study of CAM2047 for treatment of chemotherapy-induced nausea and vomiting (CINV), and CAM2048 and CAM2058 for treatment of pain, nausea and vomiting. Study results are expected third quarter 2017. We are also preparing the start of the first clinical trial of our sub-
cutaneous treprostinil depot, CAM2043, aiming at the development of a new treatment alternative for pulmonary arterial hypertension (PAH); a rare, serious and life-threatening condition affecting the lungs and heart.
Camurus is expanding with good prospects of further growth and continued value creation. This is reflected by an increasing interest from both pharmaceutical companies and the international investor community, for instance, in connection with our presentations and at J.P. Morgan and Cowen and Co. Annual Health Care Conferences earlier in the year.
In parallel with the advances in our product pipeline, we are also building our commercial organization for the anticipated launch of CAM2038 in 2018. To support the business expansion, we have strengthened the management team and organization with new functions and expertise. Urban Paulsson, with broad and international expertise from the pharmaceutical industry, was recently appointed as VP Corporate Development & General Counsel, and Cecilia Callmer, previously at Novo Nordisk and Ferring Pharmaceuticals, has taken the position as VP Human Resources.
We have had a good start of the year, with the recent announcement of positive Phase 3 results, and are now about to enter the registration phase with CAM2038. We are also having good progress in other clinical programs and look forward to a continued positive news flow during the year.
Fredrik Tiberg President & CEO
• Positive topline Phase 3 results from long-term safety study of CAM2038 for 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.
| PARTNER | PRODUCT | PRE-CLINICAL | PHASE 1-2 | PHASE 3 | REGISTRATION |
|---|---|---|---|---|---|
| CAM2038 q1w OPIOID DEPENDENCE | PHASE 3 | ||||
| CAM2038 q4w OPIOID DEPENDENCE | PHASE 3 | ||||
| CAM2038 q1w CHRONIC PAIN | PHASE 3 | ||||
| CAM2038 q4w CHRONIC PAIN | PHASE 3 | ||||
| CAM2029 NEUROENDOCRINE TUMORS | PHASE 1-2 | ||||
| CAM2029 ACROMEGALY | PHASE 1-2 | ||||
| CAM2032 PROSTATE CANCER | PHASE 1-2 | ||||
| CAM4071 UNDISCLOSED INDICATION | PHASE 1-2 | ||||
| CAM2047 CINV1 | PHASE 1-2 | ||||
| CAM2048 POSTOPERATIVE PAIN | PHASE 1-2 | ||||
| CAM2058 POSTOPERATIVE PAIN & PONV2 | PHASE 1-2 | ||||
| CAM4072 GENETIC OBESITY | |||||
| CAM2043 PAH3 | |||||
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 treatment of opioid dependence. The products are based on Camurus' proprietary FluidCrystal® Injection depot technology and are intended for either weekly (q1w) or monthly (q4w) administration by healthcare personnel using prefilled syringes, provided with multiple doses, to allow individualized treatment of patients with opioid dependence. Patients being treated with CAM2038 are freed from the burden and stigma associated with the daily, often supervised, distribution and administration of present buprenorphine medications. CAM2038 also has the potential to generate substantial savings for healthcare and society by reducing costs of frequent supervised treatment, improving treatment compliance and lowering diversion, misuse and abuse.
In November 2016, we announced positive results from a pivotal, randomized, double-blind, double-dummy, active-controlled, 24 weeks, efficacy Phase 3 trial of CAM2038. The results demonstrated that CAM2038 met both primary and secondary endpoints in terms of non-inferior respectively superior efficacy of CAM2038 versus daily sublingual buprenorphine/naloxone which is the current Standard of Care. In the first quarter, we completed treatment of opioid patients in the second Phase 3 trial of CAM2038; an open-label, long-term safety study in patients with opioid use disorder. Positive topline results from this study were reported in May 2, 2017.
Furthermore, a Phase 2 study evaluating pharmacokinetics of CAM2038 during repeated dosing is being completed (see chronic pain section). These studies are part of the registration program, which has been agreed with both FDA and EMA. CAM2038 has previously been granted Fast Track status for the treatment of opioid dependence by the FDA, and applications for marketing approvals in the US and Europe are planned to be submitted in mid-2017.
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 being developed to provide round-theclock pain relief, while decreasing the risks 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 to the targeted properties for treatments of chronic pain, i.e. the combination of long lasting efficacious analgesia with a reduced risk of misuse, abuse and illicit diversion.
In patients with chronic pain and opioid dependence, the Phase 2 trial of CAM2038 assessing pharmacokinetics, analgesia and safety profiles of repeat doses of weekly and monthly CAM2038 is progressing; two dose groups have been completed and an additional dose group has been included. The study is presently being finalized and results are expected in the second quarter 2017. In parallel, a Phase 3 pivotal trial assessing efficacy of CAM2038 in patients with moderate to severe chronic lower back pain is ongoing.
CAM2029 is being developed by Novartis, with support from Camurus, for the treatment of acromegaly and neuroendocrine tumors. The product offers important potential advantages over current marketed products, including easy administration, significantly increased bioavailability of octreotide, and potential for enhanced treatment efficacy in patients for whom current treatments provide only suboptimal treatment effects. 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 is provided in a prefilled syringe, thus not requiring any preparations or temperature conditioning prior to administration. Due to the superior ease of handling and administration, CAM2029 can be conveniently administered by the patients' themselves.
The recently completed Phase 2 trial of CAM2029 demonstrated long-acting octreotide release with well-maintained control of symptoms and disease biomarkers after switching patients from the current market leading product Sandostatin® LAR®. The efficacy evaluation was based on assessment of the control of symptoms in NET patients and plasma levels of insulin growth factor-1 and growth hormone in acromegaly patients. The results were presented in March at European Neuroendocrine Tumor Society 2017 in Barcelona, Spain, and in April at the Endocrine Society Annual Meeting, ENDO 2017, Orlando, Florida. Full publication is being compiled. Furthermore, Novartis, in collaboration with Camurus, is completing GMP manufacturing and other preparations of Phase 3 trials of CAM2029, planned to start in 2017.
The well established hormone therapies for prostate cancer based on using gonadotropinreleasing hormone agonists such as leuprolide, are aiming at reduction of the testosterone level and thereby impeding the growth of cancer cells. CAM2032 is a long-acting subcutaneous leuprolide depot for treatment of prostate cancer. Additional potential indications for CAM2032 include precocious puberty, gender identity disorders, and endometriosis. This monthly depot is based on Camurus' FluidCrystal® Injection depot technology and will be provided as a small dose volume in a prefilled syringe requiring no reconstitution or conditioning. CAM2032 is being developed for easy subcutaneous injections by patients themselves.
Discussions with potential partners for further clinical development are ongoing.
At Camurus, we continuously assess new opportunities where our drug delivery technologies effectively can be used to develop differentiated products. Our new pipeline projects are generated in-house as well as in partnership with international biotech and pharmaceutical companies
CAM4071 is a product candidate in clinical development under the option, collaboration and licensing agreement with Novartis. The product is a long-acting formulation of an undisclosed peptide based on the FluidCrystal® Injection depot. A Phase 1 trial of pharmacokinetics and pharmacodynamics, performed together with Novartis, has been completed and is being reported.
CAM2047, CAM2048, and CAM2058 are three investigational drug products based on Camurus' FluidCrystal® Injection depot and are currently evaluated in a Phase 1 trial. These investigational products are being developed for treatment of chemotherapy induced nausea and vomiting (CAM2047), pain (CAM2048) and combined treatment of postoperative pain, nausea and vomiting (CAM2058). Results from the clinical study are expected during the third quarter 2017.
CAM2043 is a new long-acting subcutaneous treprostinil depot, based on Camurus' FluidCrystal® injection depot, being developed for treatment of pulmonary arterial hypertension (PAH). Data from the recently completed preclinical program show promising plasma exposure with treprostinil, comparable with those reported in infusion studies, and no significant reactions at the injection site. A potential clinical development program is being evaluated for a possible start during the second half-year of 2017.
episil® oral liquid is a medical device for treatment of inflammatory and painful conditions in the oral cavity. The product provides fast pain relief and protection of sore and inflamed mucosal surfaces, caused by e.g. oral mucositis, a common and serious side effect of cancer treatment. In contact with the buccal membrane, episil® transforms into a thin protective layer of gel, offering effective pain relief for up to 8 hours. episil® oral liquid is based on Camurus' FluidCrystal® topical bioadhesive technology.
In December, Camurus' partner Solasia Pharma signed an agreement with Meiji Seika Pharma for commercialization of episil® in Japan. Market registration processes are ongoing in Japan and China. During the period, Camurus signed an agreement with Ethypharm for the distribution of episil® in France. In the US, Camurus partner, R-Pharm continues launching of episil®, with initial focus on breast cancer patients.
Revenues during the quarter amounted to MSEK 17.2 (20.2), generated from license agreements, project activities and product sales.
Marketing, business development and distribution costs during the quarter, were MSEK 7.1 (4.3).
Administrative expenses amounted to MSEK 4.4 (3.7). R&D costs, including depreciation and amortization of tangible and intangible assets were MSEK 54.1 (35.4).
Other operating expenses mainly consist of currency exchange losses in operational activities, were MSEK 0.1 (1.7). The operating result for the quarter was MSEK -51.6 (-24.9).
Financial items for the period was MSEK -0.0 (-0.0). Tax was MSEK 11.3 (5.5) and is mainly attributable to deferred tax for losses during the quarter.
The result for the period was MSEK -40.2 (-19.4), corresponding to earnings per share of SEK -1.08 (-0.52) before and after dilution.
Cash flow from operating activities, before change in working capital, was negative and amounted to MSEK -50.6 (-34.0).
Change in working capital affected the cash flow positively by MSEK 7.0 (-110.1) and the difference relates to the payment in January 2016 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 in December 2015.
Cash flow from investing activities was MSEK -1.2 (-0.1).
The Company's cash position as of March 31, 2017, was MSEK 463.8 (571.9). The difference compared to previous year is mainly attributable to the operating result.
There were no outstanding loans as of March 31, 2017, and no loans have been taken up since.
Consolidated equity as of March 31, 20167 was MSEK 524.2 (621.1).
As a part of the establishment of the European commercial organization, a wholly owned subsidiary has been set up in UK.
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 (37,281,486).
In accordance with a decision by a Shareholder's General Meeting in May 2016, an incentive program (TO2016 / 2019) under which a maximum of 550 000 warrants can be issued, was introduced. The dilution of a full utilization of the program corresponds to 1.5% of the share capital and voting rights. The number of warrants that have been issued are 550 000 and which give the right to subscribe for an equal number of shares during the period May 15, 2019 - December 15, 2019. During the quarter, no warrants have been subscribed for and as by end of March 31, 2017, 404 300 warrants had been subscribed for in total.
Revenues for the quarter amounted to MSEK 17.3 (20.0) and the result after tax was MSEK -39.9 (-19.0).
On March 31, 2017, equity in the Parent Company amounted to MSEK 507.1 (603.6).
Total assets at the end of the period was MSEK 584.6 (661.4) of which MSEK 463.6 (571.9) were cash and cash equivalents.
At the end of the period, Camurus had 64 (49) employees, of whom 47 (36) were within research and development. The full time equivalent employees (FTEs) during the quarter was 59 (48).
The company management makes estimates and assumptions about the future. Such estimates can deviate considerably from the actual outcome, since they are based on various assumptions and experiences.
The estimates and assumptions that may lead to the risk of significant adjustments to reported amounts for assets and liabilities relate mainly to measurement and allocation of revenues and costs in connection with licensing agreements and deferred tax receivables.
Risks in ongoing development projects comprise technical and manufacturing related risks (including products failing to meet set specifications post manufacturing), safety and effect-related risks that can arise in clinical trials, regulatory risks relating to non-approval or delays of clinical trial applications and market approvals, and commercial risks relating to the sale of proprietary and competing products and their development on the market, as well as IP risks relating to approval of patent applications and patent protection. In addition, there are risks relating to the development, strategy and management decisions of Camurus' partners. Camurus pursues operations and its business on the international market and the Company is therefore exposed to currency risks, since revenues and costs arise in different currencies, mainly SEK, EUR and USD.
The Board of Directors has not changed its outlook on future developments in relation to their outlook published in the annual report for 2016.
Camurus Annual General Meeting 2017 will be held on Wednesday 3 May, at 17.00 CET, at Elite Hotel Ideon, Scheelevägen 27, Ideon Science Park, 223 63 Lund.
This report has not been reviewed by the company's auditors.
For further information, please contact: Fredrik Tiberg, Chief Executive Officer Rein Piir, VP Investor Relations Tel.: +46 46 286 46 92, e-mail: [email protected].
Lund, May 3, 2017 Camurus AB Board of Directors
| KSEK Note |
2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Net sales 3 |
17,192 | 20,246 | 113,737 |
| Cost of goods sold |
-32 | -63 | -2,140 |
| Gross profit | 17,161 | 20,183 | 111,597 |
| Marketing and distribution costs |
-7,093 | -4,298 | -24,738 |
| Administrative expenses |
-7,412 | -3,715 | -17,985 |
| Research and development costs |
-54,143 | -35,394 | -172,077 |
| Other operating income |
– | 16 | 751 |
| Other operating expenses |
-101 | -1,650 | – |
| Operating result | -51,588 | -24,857 | -102,452 |
| Finance income |
1 | 2 | 95 |
| Finance expenses |
-3 | -37 | -1,002 |
| Net financial items | -2 | -35 | -907 |
| Result before tax | -51,590 | -24,893 | -103,359 |
| Income tax 8 |
11,343 | 5,476 | 22,367 |
| Result for the period | -40,247 | -19,416 | -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
| SEK | 2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Earnings per share before dilution, SEK Earnings per share after dilution, SEK |
-1,08 -1,08 |
-0,52 -0,52 |
-2,17 -2,17 |
Presently, the company has one subscription warrant program active. For further information see page 8, Camurus' share.
| KSEK | Note 31-03-2017 |
31-03-2016 | 31-12-2016 | KSEK Note |
31-03-2017 | 31-03-2016 | 31-12-2016 |
|---|---|---|---|---|---|---|---|
| ASSETS | EQUITY | ||||||
| Fixed assets | Equity attributable to parent company | ||||||
| shareholder | |||||||
| Intangible assets | Share capital |
932 | 932 | 932 | |||
| Capitalized development expenditure |
18,219 | 20,303 | 18,741 | Other contributed capital |
631,034 | 626,181 | 631,034 |
| Retained earnings, including result for the period |
-107,797 | -5,972 | -67,549 | ||||
| Tangible assets | Total equity | 9 524,170 |
621,141 | 564,418 | |||
| Equipment | 10,463 | 6,450 | 9,759 | ||||
| LIABILITIES | |||||||
| Financial assets | Long-term liabilities | ||||||
| Long-term receivables Group companies |
– | – | – | Deferred tax liability |
– | – | – |
| Deferred tax receivables |
8 73,027 |
44,794 | 61,685 | Total long-term liabilities | – | – | – |
| Total fixed assets | 101,710 | 71,546 | 90,185 | ||||
| Short-term liabilities | |||||||
| Current assets | Liabilities to Group companies |
– | – | – | |||
| Trade payables |
13,053 | 7,566 | 17,560 | ||||
| Inventories | Income taxes |
– | – | – | |||
| Finished goods, raw materials and products in work |
8,251 | 3,157 | 12,380 | Other liabilities |
6,225 | 3,890 | 2,571 |
| Current receivables | Accrued expenses and deferred income |
54,145 | 43,589 | 55,228 | |||
| Receivables from Group companies |
– | – | – | Total short-term liabilities | 73,424 | 55,045 | 75,358 |
| Trade receivables |
6,689 | 14,170 | 8,304 | TOTAL EQUITY AND LIABILITIES | 597,593 | 676,186 | 639,776 |
| Other receivables |
5,459 | 6,015 | 3,855 | ||||
| Prepayments and accrued income |
11,681 | 9,381 | 16,459 | ||||
| Total current receivables | 5 23,829 |
29,566 | 28,618 | ||||
| Cash and cash equivalents | 463,804 | 571,916 | 508,594 | ||||
| Total current assets | 495,884 | 604,640 | 549,592 | ||||
| TOTAL ASSETS | 597,593 | 676,186 | 639,776 |
| KSEK | Note | Share capital |
Other contributed capital |
Retained earnings, including result for the period |
Total equity |
|---|---|---|---|---|---|
| Opening balance 1 January 2016 Result for the period and comprehensive income |
932 | 626,181 | 13,444 -19,416 |
640,557 -19,416 |
|
| Transactions with shareholders | – | – | – | – | |
| Closing balance 31 Mars 2016 | 932 | 626,181 | -5,972 | 621,141 | |
| 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 |
-40,248 | -40,248 | |||
| Transactions with shareholders | |||||
| Warrants issued |
– | – | – | – | |
| Closing balance 31 March 2017 | 9 | 932 | 631,034 | -107,797 | 524,170 |
| KSEK | Note | 2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|---|
| Operating activities | ||||
| Operating profit/loss before financial items |
-51,588 | -24,857 | -102,452 | |
| Adjustments for non-cash items |
7 | 1,013 | 840 | 3,524 |
| Interest received |
1 | 2 | 95 | |
| Interest paid |
-3 | -37 | -1,002 | |
| Income taxes paid |
– | -9,917 | -9,917 | |
| -50,577 | -33,969 | -109,752 | ||
| Increase/decrease in inventories |
4,129 | 84 | -9,139 | |
| Increase/decrease in trade receivables |
1,616 | -5,253 | 613 | |
| Increase/decrease in other current receivables |
3,174 | 5,923 | 1,005 | |
| Increase/decrease in trade payables |
-4,507 | -24,266 | -14,272 | |
| Increase/decrease in other current operating liabilities |
2,569 | -86,564 | -76,243 | |
| Cash flow from changes in working capital | 6,981 | -110,076 | -98,036 | |
| Cash flow from operating activities | -43,596 | -144,045 | -207,788 | |
| Investing activities | ||||
| Acquisition of intangible assets |
– | – | – | |
| Acquisition of tangible assets |
-1,195 | -135 | -4,567 | |
| Divestment/amortization of other financial assets |
– | – | – | |
| Increase/decrease in current financial investments |
– | – | – | |
| Cash flow from investing activities | -1,195 | -135 | -4,567 | |
| Financing activities | ||||
| Increase/decrease in current financial liabilities |
– | – | – | |
| Warrants issued |
– | – | 4,853 | |
| Cash flow from financing activities | – | – | 4,853 | |
| Net cash flow for the period | -44,791 | -144,180 | -207,502 | |
| Cash and cash equivalents at beginning of period |
508,594 | 716,096 | 716,096 | |
| Exchange rate differences in cash equivalents |
– | – | – | |
| Cash and cash equivalents at the end of period | 463,804 | 571,916 | 508,594 |
| KSEK Note |
2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Net sales |
17,337 | 20,246 | 113,737 |
| Cost of goods sold |
-32 | -63 | -2,140 |
| Gross profit | 17,305 | 20,183 | 111,597 |
| Marketing and distribution costs |
-7,232 | -4,298 | -24,738 |
| Administrative expenses |
-7,555 | -3,715 | -17,985 |
| Research and development costs |
-53,621 | -34,873 | -169,994 |
| Other operating income |
– | 16 | 751 |
| Other operating expenses |
-101 | -1,650 | – |
| Operating result before items affecting comparability | -51,204 | -24,337 | -100,370 |
| Result from interests in Group companies |
– | – | – |
| Interest income and similar items |
1 | 2 | 95 |
| Interest expense and similar items |
-3 | -37 | -1,002 |
| Result after financial items | -51,206 | -24,372 | -101,277 |
| Appropriations | – | – | -1,246 |
| Result before tax | -51,206 | -24,372 | -102,523 |
| Tax on profit for the period 8 |
11,265 | 5,362 | 22,183 |
| Result for the period | -39,941 | -19,010 | -80,340 |
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 |
31-03-2017 | 31-03-2016 | 31-12-2016 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Tangible fixed assets | |||
| Equipment | 10,463 | 6,450 | 9,759 |
| Financial fixed assets | |||
| Interest in Group companies |
816 | 573 | 816 |
| Deferred tax assets |
8 77,839 |
49,753 | 66,574 |
| Total fixed assets | 89,118 | 56,775 | 77,149 |
| Current assets | |||
| Inventories | |||
| work Finished goods, raw materials and products in |
8,251 | 3,157 | 12,380 |
| Current receivables | |||
| Receivables from parent company |
– | – | – |
| Trade receivables |
6,689 | 14,170 | 8,304 |
| Other receivables |
5,244 | 6,015 | 3,855 |
| Prepayments and accrued income |
11,681 | 9,383 | 16,459 |
| Total current receivables | 23,614 | 29,568 | 28,618 |
| Cash and bank deposits | 463,566 | 571,916 | 508,351 |
| Total current assets | 495,431 | 604,642 | 549,351 |
| TOTAL ASSETS | 584,549 | 661,417 | 626,499 |
| KSEK | Note | 31-03-2017 | 31-03-2016 | 31-12-2016 |
|---|---|---|---|---|
| EQUITY AND LIABILITIES Restricted equity |
||||
| Restricted equity (37 281 486 shares) |
932 | 932 | 932 | |
| Statutory reserve |
11,327 | 11,327 | 11,327 | |
| Total restricted equity | 12,259 | 12,259 | 12,259 | |
| Unrestricted equity | ||||
| Retained earnings |
-62,595 | 17,746 | 17,746 | |
| Share premium reserve |
597,418 | 592,565 | 597,418 | |
| Result for the period |
-39,941 | -19,010 | -80,340 | |
| Total unrestricted equity | 494,883 | 591,300 | 534,823 | |
| TOTAL EQUITY | 507,142 | 603,560 | 547,083 | |
| LIABILITIES | ||||
| Untaxed reservesr | ||||
| Depreciation/amortization in excess of plan |
3,486 | 2,239 | 3,486 | |
| Total untaxed reserves | 3,486 | 2,239 | 3,486 | |
| Long-term liabilities | ||||
| Liability to subsidiaries |
1,945 | 573 | 573 | |
| Total long-term liabilities | 1,945 | 573 | 573 | |
| Short-term liabilities | ||||
| Liabilities to Group companies |
– | – | – | |
| Trade payables |
13,053 | 7,566 | 17,560 | |
| Current tax liability |
– | – | – | |
| Other liabilities |
5,130 | 3,890 | 2,571 | |
| Accrued expenses and deferred income |
53,793 | 43,589 | 55,227 | |
| Total short-term liabilities | 71,976 | 55,045 | 75,358 | |
| TOTAL EQUITY AND LIABILITIES | 584,549 | 661,417 | 626,499 |
| Key figures, MSEK | 2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Net revenues |
17,2 | 20,2 | 113,7 |
| Operating result |
-51,6 | -24,9 | -102,5 |
| Result for the period | -40,2 | -19,4 | -81,0 |
| Cash flow from operating activities |
-43,6 | -144,0 | -207,8 |
| Cash and cash equivalents |
463,8 | 571,9 | 508,6 |
| Equity | 524,2 | 621,1 | 564,4 |
| Equity ratio in Group, percent |
88% | 92% | 88% |
| Total assets |
597,6 | 676,2 | 639,8 |
| Average number of shares, before dilution |
37 281 486 |
37 281 486 |
26 281 486 |
| Average number of shares, after dilution*) |
37 685 786 |
37 281 486 |
37 487 937 |
| Earnings per share before dilution, SEK |
-1,08 | -0,52 | -2,17 |
| Earnings per share after dilution, SEK*) |
-1,08 | -0,52 | -2,17 |
| Equity per share before dilution, SEK |
14,06 | 16,66 | 15,14 |
| Equity per share after dilution, SEK*) |
13,91 | 16,66 | 15,06 |
| Number of employees at end of period |
64 | 49 | 62 |
| Number of employees in R&D at end of period |
47 | 36 | 44 |
| R&D costs as a percentage of operating expenses |
79% | 82% | 80% |
*) The dilution effect is calculated according to IAS 33
Cash and cash bank balances
Equity ratio, % Equity divided by total capital
Weighted average number of shares before adjustment for dilution effect of net shares
Weighted average number of shares adjustment for the dilution effect of new shares
Result divided by the weighted average number of shares outstanding before dilution
Result divided by the weighted average number of shares outstanding after dilution
Equity divided by the weighted number of shares at 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, 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. Camurus AB's registered offices is based in Lund, Sweden, at Ideon Science Park, 223 70 Lund. Camurus AB Group's interim report for the first quarter 2017 was approved for publication in accordance with a decision from the Board on May 3, 2017.
All amounts are stated in SEK thousand (KSEK), unless otherwise indicated. Figures in brackets refer to the year-earlier period.
The consolidated financial statements for the Camurus AB Group ('Camurus') have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU, as well as the Swedish Financial Reporting Board's Recommendation RFR 1 Supplementary Accounting Rules for Groups, and the Swedish Annual Accounts Act.
This interim report has been drawn up in accordance with IAS 34, Interim Financial Reporting, the Swedish Annual Accounts Act and RFR 1 Supplementary Accounting Rules for Groups.
The parent company statements have been prepared in accordance with the Annual Accounts Act and recommendation RFR 2 Accounting for legal entities from the Swedish Financial Reporting Board. The application of RFR 2 means that the parent company in the interim report for the legal entity shall apply all EU-approved IFRS standards and statements as far as possible within the framework of the Annual Accounts Act, the Pension Obligations Vesting Act (Tryggandelagen) and taking into consideration the relationship
between accounting and taxation. The parent company's accounting policies are the same as for the Group, unless otherwise stated in Note 2.2.
The most important accounting policies that are applied in the preparation of these consolidated financial statements are detailed below.
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.
Warrant program TO2016/2019
Presently Camurus has one long-term incentive program active. In accordance with a decision by the Annual General Meeting in May 2016, an incentive program, TO2016 / 2019, for the company's employees, under which a maximum of 550,000 warrants can be issued, was introduced. The warrants were valued by an independent institute in accordance with the Black&Scholes model and were acquired by the participants at market value. As part of the program, the participants receive a threepiece stay-on bonus in the form of gross salary addition from the company, equivalent to the amount paid by the participant for its subscription warrants. As the stay-on bonus is conditional on continued employment costs, including social security cost, are expensed over the vesting period and a liability is calculated at each balance sheet date based on how much has been earned. Expenses are recognized as personnel expense in the income statements. -based payment
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 handles. As the business, i.e. the development of pharmaceutical products based on Camurus' technology platform, the Group 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 are 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. results.
To follow is a breakdown of revenues from all products and services.
| KSEK | 2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Sales of development related goods and services |
13,927 | 15,971 | 68,112 |
| Milestone payments |
2,205 | – | 34,217 |
| Licensing revenues |
835 | 4,275 | 8,485 |
| Other | 225 | – | 2,923 |
| Total | 17,192 | 20,246 | 113,737 |
Revenues from external customers is allocated by country, based on where the customers are located.
| KSEK | 2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Europé | 1,375 | 7,549 | 22,921 |
| (of which Sweden) |
(59) | (1,673) | (3,727) |
| North America |
15,670 | 12,572 | 87,359 |
| Other geographical areas |
147 | 125 | 3,457 |
| Total | 17,192 | 20,246 | 113,737 |
Revenue during the quarter of approximately MSEK 13.2 (7.9) 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 | 2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Result attributable to parent company shareholders |
-40,247 | -19,416 | -80,993 |
| Total | -40,247 | -19,416 | -80,993 |
| Weighted average number of ordinary shares outstanding (thousands) | 37,281 | 37,281 | 37,281 |
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 | 2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Result attributable to parent company shareholders |
-40,247 | -19,416 | -80,993 |
| Total | -40,247 | -19,416 | -80,993 |
| Weighted average number of ordinary shares outstanding (thousands) | 37,281 | 37,281 | 37,281 |
| Adjustments: | |||
| – warrants (thousands) |
404 | – | 207 |
| – share issues (thousands) |
– | – | – |
| Weighted average number of ordinary shares in calculation of earnings per share after dilution (thousands) |
37,688 | 37,281 | 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.
| Carrying amount, KSEK | 31-03-2017 | 31-03-2016 | 31-12-2016 |
|---|---|---|---|
| Loans and receivables | |||
| Trade receivables |
6,689 | 14,170 | 8,304 |
| Receivables from Group companies |
– | – | – |
| Other receivables |
– | – | – |
| Cash and cash equivalents |
463,804 | 571,916 | 508,594 |
| Total | 470,493 | 586,086 | 516,898 |
| Other liabilities | |||
| Other financial liabilities |
– | – | – |
| Liabilities to Group companies |
– | – | – |
| Trade payables |
13,053 | 7,566 | 17,560 |
| Other current liabilities |
191 | 191 | 191 |
| Total | 13,244 | 7,757 | 17,751 |
Investor relations services have been acquired from Piir & Partners AB, whose representative is a member of the management team. Pricing is done in accordance with allocation of costs in relation to utilization rate and on market terms. At the end of the period the company had a debt to Piir & Partner AB regarding these services that amounted to MSEK 0.3 (0.2).
Adjustment for non-cash items:
| KSEK | 2017 Jan – March |
2016 Jan – March |
2016 Jan – Dec |
|---|---|---|---|
| Depreciation | 1,013 | 840 | 3,524 |
| Total | 1,013 | 840 | 3,524 |
Tax for the quarter amounted to MSEK 11.3 (5.5), primarily attributable to the negative result.
The change in equity for the quarter is mainly attributable to the loss.
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 13.00 PM CET on May 3, 2017.
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
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