Interim / Quarterly Report • Jul 13, 2017
Interim / Quarterly Report
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INTERIM REPORT Q2 2017
Q3 2017 26 October 2017 Full Year Report 2017 15 February 2018 Annual Report 2017 22 March 2018
"Our comprehensive clinical program has been completed, demonstrating robust efficacy and good safety profile of CAM2038 in opioid dependent individuals."
Camurus is committed to developing and commercializing and long-term 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 ad resources utilization. The company's share is listed on Nasdaq Stockholm under the ticker "CAMX". For more information, visit camurus.com.
Several important milestones were achieved during the second quarter. Our comprehensive clinical program has been completed, demonstrating robust efficacy and good safety profile of CAM2038 in opioid dependent individuals. Results from clinical studies were published in scientific journals and featured in four presentations at the College on Problem Drugs and Dependence 79th Annual Meeting held in Montreal in June.
In the completed 48-week Phase 3 safety study, 227 opioid dependent participants were dosed with CAM2038 across Europe, Australia, and the US. The study included both treatment seeking individuals and patients transferred from standard daily treatment with sublingual buprenorphine medications to CAM2038. The safety profile was good with no drug related serious or unexpected adverse events. Treatment effectiveness, as measured by the percentage illicit opioid-free patients and retention in treatment, was noticeable in both populations across the study. For treatment seeking individuals, the percentage of opioid-free patients increased by more than 60%. Clinically observed withdrawal symptom scores were insignificant in both groups (less than 2, scale 0-48) after the first treatment month. Patient satisfaction with the CAM2038 treatment was high, also compared to the pre-study treatment with daily sublingual buprenorphine.
The evidence base for weekly and monthly CAM2038 as a potential new safe and effective treatment for opioid dependence has continued to grow. The interest from physicians and other stakeholders is noticeable; as reflected by the positive response to the four presentations of CAM2038 given at the College on Problem Drugs and Dependence in Montreal, June 17-22. Results from our
opioid-blocking study were published in JAMA Psychiatry, the leading journal within Psychiatry. The study demonstrated rapid and effective blockade of opioid effects and suppression of withdrawal by CAM2038 from the first administered dose as well as during continued treatment. Thus, supporting the positioning of CAM2038 as stand-alone treatment, without the need for daily medications that may be diverted, misused and accidentally ingested by children.
With the successful completion of the clinical registration program, we now proceed to submitting our market approval applications to EMA and FDA per plan. Camurus is preparing for launch after an anticipated European approval mid-2018. We have continued to strengthen our European commercial organization with regional leadership, market access and medical affairs functions. Braeburn Pharmaceuticals is getting ready for an expected FDA approval and launch of CAM2038 in the first half of 2018.
In parallel, we and Braeburn Pharmaceuticals are working to expand the utility of CAM2038 to the treatment of chronic pain. A Phase 2 pharmacokinetic study in opioid dependent with chronic pain patients was just completed. The study demonstrated that repeated doses of weekly and monthly CAM2038 provided therapeutic buprenorphine plasma concentrations across the dosing intervals. Pain and withdrawal scores were both well maintained compared to pre-treatment with sublingual buprenorphine. A randomized pivotal Phase 3 study in opioid experienced patients with chronic low back pain is progressing, with study results expected early 2018. Results from a pharmacokinetic study of additional product candidates (CAM2047, CAM2048 and CAM2058) for treatment of nausea and post-operative pain, respectively, are expected the third quarter 2017.
During the period, positive initial results were a from a Phase 1a single ascending dose study of a weekly setmelanotide FluidCrystal® depot under development for treatment of rare genetic obesity disorders by our partner Rhythm. The results were
impressive according to Rhythm, meeting their criteria pharmacokinetics and tolerability for a weekly product. In the collaboration with Novartis for a long-acting octreotide (CAM2029) for treatment of acromegaly and neuroendocrine tumors, preparations for Phase 3 is progressing.
During the quarter, we strengthened our research and development team through the appointment of Maarten de Chateau, MD, PhD, as VP Medical Strategy & Innovation, with responsibility for expanding the early development pipeline.
We have had a productive first half of 2017 with important advances in several areas. Positive Phase 3 results and the successful completion of our clinical registration program for CAM2038 were important highlights. We are nearing the realization of our ambition to bring a new important treatment option for those patients suffering from the consequences of opioid dependence. I recognize the dedication and commitment of all our colleagues, investigators, and partners that enables us to achieve this.
Fredrik Tiberg President & CEO
Camurus is a research-based pharmaceutical company with a focus on the development and commercialization of new and innovative pharmaceuticals for serious and chronic conditions, where there are clear medical needs and the potential to significant 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 significant lower cost and risk, compared with development of completely new pharmaceuticals. Camurus' development pipeline contains products candidates for 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 |
|---|---|---|---|---|---|
| B camurus. |
CAM2038 q1w OPIOID DEPENDENCE | PHASE3 | |||
| $B$ raeburn * camurus. |
CAM2038 q4w OPIOID DEPENDENCE | PHASE3 | |||
| B camurus. |
CAM2038 q1w CHRONIC PAIN | PHASE3 | |||
| camurus. $\mathbb{E}{\mathsf{Bra}^{\text{obust}}{\text{polar}}}$ | CAM2038 q4w CHRONIC PAIN | PHASE3 | |||
| U NOVARTIS | CAM2029 NEUROENDOCRINE TUMORS | PHASE 1-2 | |||
| U NOVARTIS | CAM2029 ACROMEGALY | PHASE 1-2 | |||
| camurus. | CAM2032 PROSTATE CANCER | PHASE 1-2 | |||
| U NOVARTIS | CAM4071 UNDISCLOSED INDICATION | PHASE 1-2 | |||
| camurus. | CAM2047 CINV1 | PHASE 1-2 | |||
| æ camurus. Braeburn * |
CAM2048 POSTOPERATIVE PAIN | PHASE 1-2 | |||
| B camurus. |
CAM2058 POSTOPERATIVE PAIN & PONV 2 | PHASE 1-2 | |||
| rhýthm | CAM4072 GENETIC OBESITY | PHASE 1-2 | |||
| camurus. | CAM2043 PAH3 |
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 investigational products are based on Camurus' proprietary FluidCrystal® injection depot technology and are intended for either weekly or monthly administration by healthcare personnel using prefilled syringes, provided in 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 May 2017, positive results from a long-term Phase 3 trial confirming the safety profile and efficacy of CAM2038 in both new-to-treatment patients and patients on maintenance treatment with daily sublingual buprenorphine were announced. During the quarter, new study data from the clinical development program of CAM2038 were presented at the annual meeting of The College on Problems of Drug Dependence in Montreal, Canada, including Phase 3 efficacy results, Phase 2 data of opioid blockade and withdrawal suppression of CAM2038 as well as pharmacokinetic and
pharmacodynamic evaluations of opioid blockade by CAM2038. Results for CAM2038 was published in JAMA Psychiatry and Journal of Substance Abuse Therapy. The clinical program of CAM2038 in opioid dependent individuals was completed as planned and demonstrate robust efficacy and good safety profile. Applications for marketing approvals in the US and Europe are progressing according to plan. CAM2038 has previously been granted Fast Track status for the treatment of opioid dependence in the US, which allows for Priority Review by the FDA.
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-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 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.
The Phase 2 trial of CAM2038 assessing pharmacokinetics, analgesia and safety profiles of repeat doses of weekly and monthly CAM2038 in patients with chronic pain and opioid dependence was recently completed. The study demonstrated that repeated doses of weekly and monthly CAM2038 provided therapeutic buprenorphine plasma concentrations across the dosing intervals and that pain and withdrawal scores were both well maintained compared to pre-treatment with sublingual buprenorphine. The ongoing Phase 3 pivotal trial assessing efficacy of CAM2038 in patients with moderate
to severe chronic lower back pain is progressing and results are expected beginning of 2018.
CAM2029 is being developed by Novartis, with support from Camurus, for the treatment of acromegaly and neuroendocrine tumours.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 superior ease of handling and administration, CAM2029 can be conveniently administrated by the patients' themselves.
The Phase 2 trial of CAM2029 that was completed last year 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 of NET patients and plasma levels of insulin growth factor-1 and growth hormone in acromegaly patients. The results have been presented at ENETS, ENDO and 2017. Preparations for start of Phase 3 studies for treatment of acromegaly and neuroendocrine tumours are proceeding.
The well-established hormone therapies for prostate cancer based on gonadotropin releasing 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 still 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 candidate 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 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 is being evaluated.
Under a license agreement, Rhythm is developing a onceweekly formulation of setmelanotide (RM-493) based on Camurus' FluidCrystal® technology. Setmelanotide is a novel melanocortin-4 receptor agonist (MC4R) for
treatment of genetic obesity. In June, positive initial results from an ongoing Phase 1a clinical trial evaluating the pharmacokinetics and tolerability of CAM4072 were announced.
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.
Preparations for the commercialization of episil® in Japan are on-going in tight collaboration with our partner Solasia Pharma and their local distribution partner Meiji Seika. In July, after the reporting period, Solasia announced that episil® has been approved for marketing in Japan by the Japanese Ministry of Health, Labour and Welfare. On other markets the work of establishing episil® is ongoing. In China, registration work is ongoing and in France, our distribution partner Ethypharm has recently launched the product.
Revenues during the quarter amounted to MSEK 19,1 (25,8), generated from license agreements, project activities and product sales.
Revenues are generated from license agreements, project activities and product sales. The difference compared to the same period last year is mainly attributable to that the revenue streams vary between quarters.
According to plan, the main cost drivers are the completion of the clinical registration 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 anticipated launch of CAM2038 in Europe.
Marketing, business development and distribution costs during the quarter, were MSEK 14,6 (5,3).
Administrative expenses amounted to MSEK 2,6 (5,8). The difference compared to the same period last year relates to redistribution of costs between administration and marketing and sales cost. Had this redistribution not been made, administration costs in the quarter would amount to 5.5 MSEK.
R&D costs, including depreciation and amortization of tangible and intangible assets were MSEK 59,0 (41,0).
Other operating expenses mainly consists of currency exchange losses in operational activities, were MSEK -0,6 (0,7).
The operating result for the quarter was MSEK -58,7 (-25,9).
Financial items for the period was MSEK -0,0 (-0,5). Tax was MSEK 12,9 (5,8) and is mainly attributable to deferred tax losses during the quarter.
The result for the period was MSEK -45,8 (-20,6), corresponding to earnings per share of SEK -1,23 (-0,55) before and after dilution.
Cash flow from operating activities, before change in working capital, was negative and amounted to MSEK -57,7 (-25,5).
Change in working capital affected the cash flow by MSEK -2,9 (-0,6).
Cash flow from investing activities was MSEK -0,3 (-0,1) and from the financing activities MSEK 10,5 (3,2) related to issuance of warrants.
The Company's cash position as of June 30, 2017, was MSEK 413,4 (549,0). The difference compared to previous year is mainly attributable to the operating result.
There were no outstanding loans as of June 30, 2017, and no loans have been taken up since.
Consolidated equity as of June 30, 2017, was MSEK 488,9 (603,8)
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. Warrant program TP2016/2016
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, and 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 1,5.0% 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.
Warrant program TO2017/2020
In accordance with a decision by the Shareholder's General Meeting in May 2017, an incentive program, TO2017/2020, was introduced. 750 000 warrants are issued, and which give the right to subscribe for an equal number of shares during the period May 15, 2020 – December 2020. The dilution of a full utilization of the program corresponds to 2.0% of the share capital and voting rights. By end of June 2017, 617 132 warrants had been subscribed for. During the quarter equity increased with MSEK 10.5 and earnings after tax were negatively impacted by MSEK 3,6 related to the stay-on bonus the participants receive as part of the program.
Revenues for the quarter amounted to MSEK 19,4 (25,8) and the result after tax was MSEK -45,3 (-20,1).
On June 30, 2017, equity in the Parent Company amounted to MSEK 472,3 (586,7).
Total assets at the end of the period was MSEK 557,7 (645,9) of which MSEK 413,2 (549,0) were cash and cash equivalents.
At the end of the period, Camurus had 66 (52) employees, of whom 47 (38) were within research and development. The full time equivalent employees (FTEs) during the quarter was 62 (49).
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 first quarter 2017.
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, July 12, 2017 Camurus AB Board of Directors
The Board of Directors and the CEO certify that this interim report gives a true and fair view of the company's and Groups' operations, financial position and results and describes significant risks and uncertainties that the Company and the companies included in the Group face.
Lund, July 12 2017
Camurus AB
Per-Olof Wallström Chairman of the Board Per-Anders Abrahamsson Board Member
Martin Jonsson Board Member
Svein Mathisen Board Member
Kerstin Valinder Strinnholm Board Member
This interim report has not been reviewed by the company's auditors.
Marianne Dicander Alexandersson Board Member
Fredrik Tiberg President and CEO, Board Member
CAMURUS INTERIM REPORT SECOND QUARTER 2017 11
| KSEK | Note | 2017 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|---|
| Net sales | 3 | 19,138 | 25,834 | 36,330 | 46,080 | 113,737 |
| Cost of goods sold |
-1,101 | -303 | -1,132 | -366 | -2,140 | |
| Gross profit | 18,037 | 25,531 | 35,198 | 45,714 | 111,597 | |
| Marketing and distribution costs | -14,577 | -5,293 | -21,557 | -9,591 | -24,738 | |
| Administrative expenses | -2,558 | -5,812 | -9,997 | -9,526 | -17,985 | |
| Research and development costs | -59,026 | -40,963 | -113,255 | -76,357 | -172,077 | |
| Other operating income | 40 | 655 | 40 | 32 | 751 | |
| Other operating expenses | -638 | - | -739 | -1,011 | - | |
| Operating result | -58,722 | -25,881 | -110,310 | -50,739 | -102,452 | |
| Finance income | 0 | 6 | 1 | 8 | 95 | |
| Finance expenses | -8 | -471 | -11 | -508 | -1,002 | |
| Net financial items | -8 | -465 | -10 | -501 | -907 | |
| Result before tax |
-58,730 | -26,347 | -110,320 | -51,240 | -103,359 | |
| Income tax | 8 | 12,927 | 5,796 | 24,270 | 11,273 | 22,367 |
| Result for the period | 4 | -45,803 | -20,551 | -86,050 | -39,967 | -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 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|
| Earnings per share before dilution, SEK | -1,23 | -0,55 | -2,31 | -1,07 | -2,17 |
| Earnings per share after dilution, SEK | -1,23 | -0,55 | -2,31 | -1,07 | -2,17 |
Presently, the company has two subscription warrant programs active. For further information see page 8, Camurus' share and page 20.
| KSEK | Note | 30-06-2017 | 30-06-2016 | 31-12-2016 | KSEK | Note | 30-06-2017 | 30-06-2016 | 31-12-2016 |
|---|---|---|---|---|---|---|---|---|---|
| ASSETS | EQUITY | ||||||||
| Fixed assets | |||||||||
| Equity attributable to parent company | |||||||||
| Intangible assets | shareholder | ||||||||
| Capitalized development expenditure | 17,697 | 19,782 | 18,741 | Share capital | 932 | 932 | 932 | ||
| Other contributed capital | 641,524 | 629,428 | 631,034 | ||||||
| Tangible assets | Retained earnings, including results for the period | -153,597 | -26,523 | -67,549 | |||||
| Equipment | 10,259 | 6,229 | 9,759 | Total equity | 9 | 488,860 | 603,837 | 564,418 | |
| Financial assets | LIABILITIES | ||||||||
| Long-term receivables Group companies | - | - | - | Long-term liabilites | |||||
| Deferred tax receivables | 8 | 85,954 | 50,589 | 61,685 | Deferred tax liability | - | - | - | |
| Total fixed assets | 113,910 | 76,600 | 90,185 | Total long-term liabilities | - | - | |||
| Current assetts | Short-term liabilities | ||||||||
| Liabilities to Group companies | - | - | - | ||||||
| Inventories | Trade payables | 17,133 | 7,571 | 17,560 | |||||
| Finished goods, raw materials and products in work |
14,048 | 3,149 | 12,380 | Income taxes | - | - | - | ||
| Other liabilities | 4,668 | 3,549 | 2,571 | ||||||
| Current receivables | Accrued expenses and deferred income | 59,742 | 45,305 | 55,228 | |||||
| Receivables from Group companies | - | - | - | Total short-term liabilities | 81,543 | 56,425 | 73,358 | ||
| Trade receivables | 12,010 | 10,747 | 8,304 | TOTAL EQUITY AND LIABILITIES | 570,403 | 660,261 | 639,776 | ||
| Other receivables | 6,230 | 3,092 | 3,855 | ||||||
| Prepayments and accrued income | 10,845 | 17,691 | 16,459 | ||||||
| Total current receivables | 5 | 43,133 | 31,530 | 28,618 | |||||
| Cash and cash equivalents | 413,360 | 548,983 | 508,594 | ||||||
| Total current assets | 456,493 | 583,661 | 549,592 | ||||||
| TOTAL ASSETS | 570,403 | 660,261 | 639,776 |
| Other | Retained earnings, |
||||
|---|---|---|---|---|---|
| contributed | including result | ||||
| KSEK | Note | Share capital | capital | for the period | Total equity |
| Opening balance 1 January 2016 | 932 | 626,181 | 13,444 | 640,557 | |
| Result for the period and comprehensive income | -39,967 | -39,967 | |||
| Transactions with shareholders | |||||
| Warrants issued | - | 3,247 | - | 3,247 | |
| Closing balance 30 June 2016 |
932 | 629,428 | -26,523 | 603,837 | |
| 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 | -86,050 | -86,050 | |||
| Exchange-rate differences | 2 | 2 | |||
| Transactions with shareholders | |||||
| Warrants issued |
- | 10,490 | - | 10,490 | |
| Closing balance 30 June 2017 | 9 | 932 | 641,524 | -153,597 | 488,860 |
| KSEK Note |
2017 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating result before financial items |
-58,722 | -25,882 | -110,310 | -50,739 | -102,452 |
| Adjustment for non-cash items 7 |
1,025 | 846 | 2,038 | 1,686 | 3,524 |
| Interest received | - | 6 | 1 | 8 | 95 |
| Interest paid | -8 | -472 | -11 | -509 | -1,002 |
| Income taxes paid | - | - | - | -9,917 | -9,917 |
| -57,705 | -25,502 | -108,282 | -59,471 | -109,752 | |
| Increase/decrease in inventories | -5,796 | 8 | -1,667 | 92 | -9,139 |
| Increase/decrease in trade receivables | -5,322 | 3,423 | -3,706 | -1,830 | 613 |
| Increase/decrease in other current receivables | 65 | -5,387 | 3,239 | 536 | 1,005 |
| Increase/decrease in trade payables | 4,081 | 5 | -426 | -24,261 | -14,272 |
| Increase/decrease in other current operating liabilities | 4,043 | 1,378 | 6,612 | -85,187 | -76,243 |
| Cash flow from changes in working capital | -2,929 | -573 | 4,052 | -110,650 | -98,036 |
| Cash flow from operating activities | -60,634 | -26,075 | -104,230 | -170,121 | -207,788 |
| Investing activities | |||||
| Acquisition of intangible assets | - | - | - | - | - |
| Acquisition of tangible assets | -299 | -104 | -1,494 | -239 | -4,567 |
| Divestment/amortization of other financial assets | - | - | - | - | - |
| Increase/decrease in current financial investments | - | - | - | - | - |
| Cash flow from investing activities | -299 | -104 | -1,494 | -239 | -4,567 |
| Financing activities | |||||
| Increase/Decrease in current financial liabilities | - | - | - | - | |
| Warrants issued |
10,490 | 3,247 | 10,490 | 3,247 | 4,853 |
| Cash flow from financing activities | 10,490 | 3,247 | 10,490 | 3,247 | 4,853 |
| Net cash flow for the period | -50,443 | -22,933 | -95,234 | -167,113 | -207,502 |
| Cash and cash equivalents at beginning of period | 463,804 | 571,916 | 508,594 | 716,096 | 716,096 |
| Exchange rate difference in cash equivalents | - | - | - | - | - |
| Cash and cash equivalents at the end of period | 413,360 | 548,983 | 413,360 | 548,983 | 508,594 |
| 2017 | 2016 | 2017 | 2016 | 2016 | |
|---|---|---|---|---|---|
| KSEK Note |
Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Jan-Dec |
| Net sales | 19,423 | 25,834 | 36,760 | 46,080 | 113,737 |
| Cost of goods sold | -1,100 | -303 | -1,132 | -366 | -2,140 |
| Gross profit | 18,323 | 25,531 | 35,628 | 45,714 | 111,597 |
| Marketing and distribution costs | -7,670 | -5,293 | -14,789 | -9,591 | -24,738 |
| Administrative expenses | -9,601 | -5,812 | -17,183 | -9,526 | -17,985 |
| Research and development costs | -58,504 | -40,443 | -112,211 | -75,316 | -169,994 |
| Other operating income | 30 | 655 | 30 | 32 | 751 |
| Other operating expenses | -637 | - | -739 | -1,011 | - |
| Operating result |
-58,061 | -25,361 | -109,265 | -49,698 | -100,370 |
| Result from interests in Group companies |
- | - | - | - | - |
| Interest income and similar items | - | 6 | 1 | 8 | 95 |
| Interest expense and similar items | -7 | -471 | -11 | -508 | -1,002 |
| Result after financial items | -58,068 | -25,826 | -109,274 | -50,198 | -101,277 |
| Appropriations | - | - | - | - | -1,246 |
| Result before tax | -58,068 | -25,826 | -109,274 | -50,198 | -102,523 |
| Tax on profit for the period 8 |
12,775 | 5,682 | 24,040 | 11,044 | 22,183 |
| Result for the period |
-45,293 | -20,145 | -85,234 | -39,155 | -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 | 30-06-2017 | 30-06-2016 | 31-12-2016 | KSEK | Note | 30-06-2017 | 30-06-2016 | 31-12-2016 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | 10,259 | 6,229 | 9,759 | Total restricted equity | 12,259 | 12,259 | 12,259 | ||
| Financial fixed assets | Unrestricted equity | ||||||||
| Interest in Group companies |
816 | 573 | 816 | Retained earnings | -62,595 | 17,746 | 17,746 | ||
| Deferred tax assets | 8 | 90,614 | 55,434 | 66,574 | Share premium reserve | 607,908 | 595,811 | 597,418 | |
| Total fixed assets | 101,689 | 62,236 | 77,149 | Result for the period | -85,234 | -39,155 | -80,340 | ||
| Total unrestricted equity | 460,080 | 574,402 | 534,823 | ||||||
| Current assets | TOTAL EQUITY | 472,339 | 586,661 | 547,083 | |||||
| Inventories | LIABILITIES | ||||||||
| Finished goods, raw materials and products in work |
14,048 | 3,149 | 12,380 | Untaxed reserves | |||||
| Depreciation/amortization in excess of plan |
3,486 | 2,239 | 3,486 | ||||||
| Current receivables | Total untaxed reserves | 3,486 | 2,239 | 3 ,86 | |||||
| Receivables from parent company | - | - | - | ||||||
| Trade receivables | 12,010 | 10,747 | 8,304 | Long-term liabilities | |||||
| Other receivables | 6,000 | 3,092 | 3,855 | Liability to subsidiaries | 571 | 573 | 573 | ||
| Prepayments and accrued income | 10,807 | 17,692 | 16,459 | Total long-term liabilities | 571 | 573 | 573 | ||
| Total current receivables | 28,817 | 31,530 | 28,618 | ||||||
| Short-term liabilities | |||||||||
| Cash and bank deposits |
413,170 | 548,983 | 508,351 | Liabilities to Group companies | 309 | - | - | ||
| Total current assets | 456,035 | 583,662 | 549,351 | Trade payables | 16,721 | 7,571 | 17,560 | ||
| TOTAL ASSETS | 557,724 | 645,898 | 626,499 | Current tax liability | - | - | - | ||
| Other liabilities | 4,668 | 3,549 | 2,571 | ||||||
| Accrued expenses and deferred income | 59,630 | 45,305 | 55,227 | ||||||
| Total short-term liabilities | 81,328 | 56,425 | 73,358 |
TOATAL EQUITY AND LIABILITY 557,724 645,898 626,499
| MSEK | 2017 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|
| Net revenues | 19,1 | 25,8 | 36,3 | 46,1 | 113,7 |
| Operating result | -58,7 | -25,9 | -110,3 | -50,7 | -102,5 |
| Result for the period | -45,8 | -20,6 | -86,0 | -40,0 | -81,0 |
| Cash flow from operating activities | -60,6 | -26,1 | -104,2 | -170,1 | -207,8 |
| Cash and cash equivalents | 413,4 | 549,0 | 413,4 | 549,0 | 508,6 |
| Equity | 488,9 | 603,8 | 488,9 | 603,8 | 564,4 |
| Equity ratio in Group, percent | 86% | 91% | 86% | 91% | 88% |
| Total assets | 570,4 | 660,3 | 570,4 | 660,3 | 639,8 |
| Average number of shares, before dilution | 37,281,486 | 37,281,486 | 37,281,486 | 37,281,486 | 37,281,486 |
| Average number of shares, after dilution*) | 37,882,454 | 37,358,426 | 37,784,664 | 37,319,956 | 37,487,937 |
| Earnings per share before dilution, SEK | -1,23 | -0,55 | -2,31 | -1,07 | -2,17 |
| Earnings per share after dilution, SEK*) | -1,23 | -0,55 | -2,31 | -1,07 | -2,17 |
| Equity per share before dilution, SEK | 13,11 | 16,20 | 13,11 | 16,20 | 15,14 |
| Equity per share after dilution, SEK*) | 12,90 | 16,16 | 12,94 | 16,18 | 15,06 |
| Number of employees at the end of period | 66 | 52 | 66 | 52 | 62 |
| Number of employees in R&D at the end of period |
47 | 38 | 47 | 38 | 44 |
| R&D costs as a percentage of operating expenses | 78% | 79% | 78% | 80% | 80% |
*) 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 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 second quarter 2017 was approved for publication in accordance with a decision by the Board of Directors on July 12, 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 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 has been made.
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 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|
| Sales of development related goods and services | 14,747 | 19,452 | 28,675 | 35,423 | 68,112 |
| Milestone payments | 0 | 2,298 | 2,205 | 2,298 | 34,217 |
| Licensing revenues | 3,079 | 4,070 | 3,914 | 8,345 | 8,485 |
| Other | 1,312 | 14 | 1,536 | 14 | 2,923 |
| Total | 19,138 | 25,834 | 36,330 | 46,080 | 113,737 |
Revenues from external customers are allocated by country, based on where the customers are located.
| KSEK | 2017 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|
| Europe | 5,702 | 7,546 | 7,076 | 15,095 | 22,921 |
| (of which Sweden) | (9) | (1,218) | (68) | (2,891) | (3,727) |
| North America | 12,989 | 15,935 | 28,659 | 28,507 | 87,359 |
| Other geographical areas | 447 | 2,353 | 595 | 2,478 | 3,457 |
| Total | 19,138 | 25,834 | 36,330 | 46,080 | 113,737 |
Revenues during the quarter of approximately MSEK 13,4 (11,5) 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 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders |
-45,803 | -20,551 | -86,050 | -39,967 | -80,993 |
| Total | -45,803 | -20,551 | -86,050 | -39,967 | -80,993 |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 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 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders |
-45,803 | -20,551 | -86,050 | -39,967 | -80,993 |
| Total | -45,803 | -20,551 | -86,050 | -39,967 | -80,993 |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 37,281 | 37,281 | 37,281 | 37,281 |
| Adjustments: | |||||
| - Warrants (thousands) |
601 | 77 | 504 | 38 | 207 |
| - Share issues (thousands) |
- | - | - | - | - |
| Weighted average number of ordinary shares in calculation of earnings per share after dilution (thousands) |
37,882 | 37,358 | 37,785 | 37,319 | 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 is a member of the management team. Pricing is done in accordance with market terms and costs are expensed in relation to utilization rate. At the end of the period the company had a debt to Piir & Partner AB regarding these services that amounted to MSEK 0,2 (0,3).
| Carrying amount, KSEK | 30-06-2017 | 30-06-2016 | 31-12-2016 |
|---|---|---|---|
| Loans and receivables | |||
| Trade receivables | 12,010 | 10,747 | 8,304 |
| Receivables from Group companies | - | - | - |
| Other receivables | - | - | - |
| Cash and cash equivalents | 413,360 | 548,983 | 508,594 |
| Total | 425,370 | 559,729 | 516,898 |
| Other liabilities | |||
| Other financial liabilities | - | - | - |
| Liabilities to Group companies | - | - | - |
| Trade payables | 17,133 | 7,571 | 17,560 |
| Other current liabilities | 191 | 191 | 191 |
| Total | 17,324 | 7,762 | 17,751 |
Adjustment for non-cash items:
| KSEK | 2017 Apr-Jun |
2016 Apr-Jun |
2017 Jan-Jun |
2016 Jan-Jun |
2016 Jan-Dec |
|---|---|---|---|---|---|
| Depreciation | 1,025 | 846 | 2,038 | 1,686 | 3,524 |
| Total | 1,025 | 846 | 2,038 | 1,686 | 3,524 |
Tax for the quarter amounted to MSEK 24,3 (5,8), primary attributable to the negative result.
The change in equity for the quarter is mainly attributable to the loss.
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 07.00 AM (CET) on July 13, 2017.
CAMURUS AB | Ideon Park, SE-223 70 Lund, Sweden P +46 286 57 30 | F +46 286 57 39 | [email protected] | camurus.com
CAMURUS INTERIM REPORT SECOND QUARTER 2017 25
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