Interim / Quarterly Report • Jul 17, 2018
Interim / Quarterly Report
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INTERIM REPORT 2018 Q2
3 CEO statement
Q3 2018 25 October 2018
Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal® technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company's share is listed on Nasdaq Stockholm under the ticker "CAMX". For more information, visit camurus.com
"We made significant progress towards regulatory approvals for CAM2038 in the US, Europe and Australia"
During the second quarter, we continued to progress approval processes for our weekly and monthly buprenorphine depots, CAM2038, for the treatment of opioid dependence, and intensified our launch preparations in Europe and Australia. We regained the worldwide rights to CAM2029 octreotide depot, received positive clinical results for CAM2043, and completed a directed share issue.
During the second quarter, we made significant progress towards regulatory approvals of CAM2038 in the US, Europe and Australia. The New Drug Application (NDA) was resubmitted to the FDA by our US partner Braeburn. After the period, we were delighted to receive notice of the FDA's acceptance of the complete response together with a PDUFA goal date of December 26, 2018. Market Authorization Application (MAA) review processes in the EU and Australia continued to advance, with expected approvals on all key markets in 2018.
Results from our randomized, double-blind, double-dummy, active-controlled Phase 3 study were published in JAMA Internal Medicine, demonstrating favorable clinical outcomes for CAM2038 versus current standard treatment with daily sublingual buprenorphine/naloxone in opioid dependent patients. This represents the first publication of Phase 3 study results for a longacting buprenorphine injectable treatment. Clinical study results, including subgroup analyses of Phase 3 results in heroin and injection drug users, have also been presented at leading international scientific addiction conferences, showing statistically improved outcomes for key measures for CAM2038 versus daily sublingual buprenorphine/naloxone.
Launch preparations for CAM2038 continued to progress. In the US, Braeburn made significant advances in establishing an effective marketing, reimbursement and distribution model for CAM2038. Responses from payors and prescribers have been encouraging. In Europe, we have further strengthened our organization within marketing, medical affairs and market access, and our commercial
teams have continued to execute on the regional go-to-market plans for CAM2038. In Australia, we recruited a business unit head with experience in the opioid dependence therapy area to build the organization and prepare for launch. Additionally, we initiated the expansion of our global distribution network to ensure access to treatment for patients outside EU and Australia and signed an agreement with Medison Pharma for commercialization of CAM2038 in Israel.
A randomized, placebo-controlled Phase 3 study of CAM2038 for the treatment of chronic low back pain was concluded in May 2018. Subsequently, our study teams have been preparing for database lock and unblinding of the study. Topline efficacy results are expected in the third quarter. Meanwhile, a long-term safety extension study of CAM2038 is ongoing, which is anticipated to be clinically completed towards the end 2018.
After regaining the exclusive worldwide rights to our CAM2029 octreotide depot and related products from Novartis, we have worked diligently to ensure a smooth transfer of the project and have also started to prepare for Phase 3 registration programs for CAM2029 in acromegaly and neuroendocrine tumors (NET). During the second half of 2018, we plan to complete ongoing manufacturing preparations for Phase 3 and engage with healthcare authorities in the EU and US to align clinical registration program updates. The market for long-acting somatostatin products, Sandostatin® LAR® and Somatuline® Autogel®, has shown steady growth for the past two decades with 2017 global sales exceeding USD 2.4 billion. Based on our product design advantages and positive clinical results from Phase 1 and 2 studies, we expect that CAM2029, if approved, could gain a significant market share and become an important catalyst for future growth and value creation for Camurus.
In our early pipeline, we obtained topline results from the first clinical study of our weekly treprostinil depot, CAM2043, in development for treatment of pulmonary arterial hypertension (PAH). Based on the positive pharmacokinetic and tolerability results in healthy volunteers, we have started preparing the further clinical development of CAM2043 in collaboration with key opinion leaders and clinical experts.
To support the commercialization of CAM2038 in Australia and the initiation of clinical development programs for CAM2029 and CAM2043, a directed share issue of approximately MSEK 102 was completed in June, securing these important activities up to the expected US approval and launch of CAM2038.
The second quarter has been intense and productive, during which our dedicated teams continued to deliver on key priorities. I am proud of the commitment of my coworkers and thankful for the many positive results that they have achieved. With the approvals of CAM2038, we will have the opportunity to positively impact the lives of hundreds of thousands of patients living with opioid dependence. In the longer term we aim to address important treatment needs in other patient groups with severe and chronic diseases.
Fredrik Tiberg, President & CEO
• FDA accepts complete response and issues user fee (PDUFA) goal date of December 26, 2018
| MSEK | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
|---|---|---|---|---|
| Net Sales | 7.3 | 19.1 | 22.0 | 36.3 |
| Operating result | -81.2 | -58.7 | -127.6 | -110.3 |
| Result after tax | -67.5 | -45,8 | -103.8 | -86.1 |
| Earnings per share SEK before and after dilution | -1.81 | -1,23 | -2.78 | -2.31 |
| Cash position | 199.1 | 413.4 | 199.1 | 413.4 |
Camurus is a research-based pharmaceutical company with a focus on the development and commercialization of new and innovative pharmaceuticals for serious and chronic conditions, where there are clear medical needs and the potential to significantly improve treatment. For the development of new drug candidates Camurus utilizes its own proprietary formulation technology, such as the long-acting injection depot FluidCrystal®. New proprietary medicines with improved properties and treatment outcomes are developed by combining the company's patented drug delivery technologies with active ingredients with documented safety and efficacy profiles. These are developed with significantly lower cost and risk, compared with the development of completely new pharmaceuticals. Camurus' development pipeline contains product candidates for the treatment of cancer and the side effects of cancer treatment, endocrine diseases, pain and addiction. A summary and status update on the different projects is given below.
| PARTNER | PRODUCT | PRE-CLINICAL | PHASE 1-2 | PHASE 3 | REGISTRATION | MARKET |
|---|---|---|---|---|---|---|
| b braeburn camurus. | CAM2038 q1w OPIOID DEPENDENCE | REGISTRATION | ||||
| b braeburn camurus. | CAM2038 q4w OPIOID DEPENDENCE | REGISTRATION | ||||
| b braeburn camurus. | CAM2038 q1w CHRONIC PAIN | PHASE3 | ||||
| b braeburn camurus. | CAM2038 q4w CHRONIC PAIN | PHASE3 | ||||
| camurus. | CAM2029 NEUROENDOCRINE TUMORS | PHASE 1-2 | ||||
| camurus. | CAM2029 ACROMEGALY | PHASE 1-2 | ||||
| camurus. | CAM2032 PROSTATE CANCER | PHASE1-2 | ||||
| camurus. | CAM2047 CINV3 | PHASE 1-2 | ||||
| b braeburn camurus. | CAM2048/58 POSTOPERATIVE PAIN & PONV4 | PHASE 1-2 | ||||
| $r$ huthm 2 | CAM4072 GENETIC OBESITY | PHASE1-2 | ||||
| camurus. | CAM2043 PAH5 | 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 is the current standard of care, effectively reducing withdrawal and cravings, misuse and spread of diseases. However, these treatments are also associated with limitations such as poor treatment adherence, misuse, medication diversion, and accidental pediatric exposure. CAM2038 is being developed as both weekly and monthly long-acting subcutaneous buprenorphine depots for the treatment of opioid dependence. The investigational products are based on our proprietary FluidCrystal® injection depot technology and are intended for subcutaneous administration by healthcare professionals 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 current buprenorphine medications. Treatment with CAM2038 also has the potential to generate substantial savings for the healthcare system and society by reducing the costs of frequent supervised treatment, improving treatment compliance, and lowering diversion, misuse and abuse.
CAM2038 has been studied in a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. A pivotal efficacy study met both the FDA and EMA primary efficacy endpoints (responder rate and mean percentage of urine samples negative for illicit opioids). In addition, superiority of CAM2038 was demonstrated for the cumulative percentage of patients with no evidence of illicit opioid use during treatment weeks 4 to 24. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine except for mild-to-moderate injection-site adverse events.
Marketing Authorization Applications (MAAs) are currently being evaluated by the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA). Final approval decisions from both authorities are anticipated in Q4 2018.
In the US, our partner Braeburn resubmitted the New Drug Application (NDA) for CAM2038 weekly and monthly buprenorphine depot injections to the US Food and Drug Administration (FDA) in May, in response to the Complete Response Letter (CRL) received in January 2018. A notification by the FDA of a Prescription Drug User Fee Act (PDUFA) action date is expected shortly.
Also in May, we announced the publication of positive Phase 3 pivotal study results for CAM2038 in the Journal of the American Medical Association (JAMA). The results, supporting efficacy and potential clinical advantages of the investigational medical product for the treatment of opioid dependence, represent the first scientific publication of Phase 3 data of a long-acting buprenorphine injection.
In June, we announced a new partnership with Medison Pharma for distribution of CAM2038 in Israel. Medison will have the exclusive right to commercialize CAM2038 in all indications, including opioid dependence and chronic pain, and will also be responsible for obtaining regulatory approval in Israel.
Chronic pain is a global health problem, 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. With CAM2038 we aim to provide the
combination of long-lasting efficacious analgesia with the reduced risk of misuse, abuse and illicit diversion.
In the Phase 3 efficacy study of CAM2038 in chronic lower-back pain, all patients have been fully treated in the efficacy phase. In the following long-term safety extension study, all patients have been included and the study is continuing according to plan. Topline results from the efficacy study are expected in Q3 2018, followed by longterm safety results in Q4 2018.
CAM2029 is being developed for the treatment of acromegaly and neuroendocrine tumors (NET). CAM2029 is a ready-to-use, long-acting subcutaneous injection of the active substance octreotide formulated with our proprietary FluidCrystal® injection depot technology. It provides several potential advantages compared to the currently marketed product Sandostatin® LAR® including higher bioavailability, fast onset of effect, and the potential for improved patient convenience. 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 NET.
In May, it was announced that Camurus regained the global development and commercialization rights to CAM2029, and related assets, from Novartis. We subsequently worked closely with Novartis to secure a smooth project and knowhow transfer from Novartis to Camurus. We plan to start the pivotal clinical program for CAM2029 during the first half of 2019.
Pulmonary arterial hypertension (PAH) is a rare and severe progressive disease characterized by elevated blood pressure in the pulmonary arteries. Without therapeutic intervention, the disease progresses rapidly and the increased pulmonary vascular resistance and incremental strain on the right ventricle leads to heart failure and death, with a median survival of 2.8 years after diagnosis. Prostacyclin analogs, such as treprostinil, are known to be efficacious, and parenteral therapy with these is recommended by guidelines for patients with severe or rapidly progressing disease. However, parenteral delivery is associated with risks of serious bloodstream infections or with infusion site pain and reactions which can be intolerable.
CAM2043 is a long-acting treprostinil formulation, based on our FluidCrystal® injection depot technology, being developed as a patient-friendly treatment option for PAH. CAM2043 is a ready-to-use subcutaneous injection which is self-administered via a prefilled syringe as a small dose volume (≤1 mL), allowing dose titration for efficacy and tolerability.
In May we announced the positive results from an openlabel Phase 1 study of single and repeated dosing of CAM2043. The topline results showed that CAM2043 provided a dose-proportional treprostinil plasma exposure and release profile suitable for weekly, or less frequent, dosing. The tolerability of CAM2043 was generally good with no observations of unexpected or serious adverse events. Injection site reactions were of mild to moderate intensity and resolved over time.
Further clinical development of CAM2043 is now being prepared and the next step will include a Phase 2 proof-ofconcept study with an expected start date in early 2019.
Several new product candidates, selected with support of market analyses, are being evaluated in pharmaceutical and pre-clinical studies. The projects comprise formulation optimization regarding release of the active substance and stability, as well as pharmacological and toxicological properties defined by the target product profiles.
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. Based on our FluidCrystal® injection depot technology, CAM2032 is being developed for self-administration with a prefilled syringe as a small dose volume which does not require any reconstitution or temperature conditioning. Additional potential indications for CAM2032 include precocious puberty and endometriosis.
Discussions with potential development and commercialization partners are ongoing.
Three new investigational products, based on our FluidCrystal® injection depot technology, are being developed for the treatment of chemotherapy induced nausea and vomiting (CAM2047), pain (CAM2048), and the combined treatment of postoperative pain, nausea and vomiting (CAM2058).
Results from a Phase 1 trial of CAM2047, CAM2048 and CAM2058 demonstrated that all products were well tolerated locally and systemically, with pharmacokinetic profiles meeting the target specifications for these product candidates. Planning of the registration program and
analysis of market potential of these product candidates are ongoing.
CAM4071 is a long-acting formulation of pasireotide based on our FluidCrystal® injection depot technology, which has been investigated in a completed Phase 1 trial. The results from the study were presented at the European Congress of Endocrinology in Barcelona in May 2018.
CAM4072, based on our FluidCrystal® technology, is a weekly formulation of the MC4 agonist setmelanotide, developed by our partner Rhythm Pharmaceuticals, for the treatment of rare genetic obesity disorders. The FDA has granted Rhythm's setmelanotide Breakthrough Therapy designation for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LepR) deficiency obesity and Orphan Designation for treatment Prader-Willis Syndrome. Results from Phase 2 clinical trials of setmelanotide demonstrated significant weight loss and substantial reductions in hunger for patients with POMC and LepR deficiency obesity. Phase 3 clinical trials are ongoing for each of these indications, and in parallel the long-acting formulation of setmelanotide, CAM4072, is being developed. Rhythm has successfully completed Phase 1 studies of single and repeat doses of CAM4072 and continued clinical studies of CAM4072 in patients with rare genetic obesity disorders are currently being prepared.
episil® oral liquid is a medical device for the treatment of inflammatory and painful conditions in the oral cavity, currently being marketed in Europe, the US and other territories. The product provides fast pain relief and protection of sore and inflamed mucosal surfaces caused, for example, by oral mucositis, a common and serious side effect of cancer treatment. When in contact with the buccal membrane, episil® transforms into a thin protective layer of gel, offering effective pain relief for up to 8 hours. episil® oral liquid is based on our FluidCrystal® topical bioadhesive technology.
In May, episil® was launched in Japan by our partner Solasia Pharma's commercialization and promotion partner, Meiji Seika Pharma, after receiving reimbursement and being added to the NHI drug reimbursement price list the previous month. Solasia also progressed with a market approval application for episil® in China, where a randomized, active-controlled Phase 3 study of episil® in patients with oral mucositis was recently completed. Study results are expected to be announced during the second half of 2018.
Revenues during the quarter amounted to MSEK 7.3 (19.1), 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. See also note 3.
Marketing, business development and distribution costs during the quarter, were MSEK -24.1 (-14.6) and Administrative expenses amounted to MSEK -5.5 (-2.6). The increase compared to the same period last year is mainly attributable to the expansion of the commercial organization in preparation of the planned launch of CAM2038 in Europe.
R&D costs, including depreciation and amortization of tangible and intangible assets were MSEK -57.3 (-59.0). The decrease compared with the same period last year is primarily attributable to costs related to completing the pivotal clinical program for CAM2038 in opioid dependence.
Other operating expenses, which mainly consist of currency exchange losses in operational activities, were MSEK -0.3 (-0.6).
The operating result for the quarter was MSEK -81.2 (-58.7).
Financial items for the period was MSEK 0.0 (-0.0). Tax was MSEK 13.6 (12.9) and is mainly attributable to deferred tax for the reported loss during the quarter.
Deferred tax assets have been updated following the decision by the Swedish Parliament in June 2018 on new corporate taxation., and the effect was not significant.
The result for the period was MSEK -67.5 (-45.8), corresponding to earnings per share of SEK -1.81 (-1.23) before and after dilution.
Cash flow from operating activities, before change in working capital, was negative and amounted to MSEK -80.0 (-57.7).
Change in working capital affected the cash flow positively by MSEK 7.9 (-2.9).
Cash flow from investing activities was MSEK -1.8 (-0.3) and from financing activities MSEK 6.7 (10.5) related to issuance of warrants.
The company's cash position as of June 30, 2018, was MSEK 199.1 (413.4). The difference compared to the previous year is mainly attributable to the operating result.
In addition, the company will receive MSEK 102.3, before issue costs, from the directed new issue that was completed in June. At end of the period, the share issue was registered but not paid. Proceeds from the issue has been paid after period.
There were no outstanding loans as of June 30, 2018, and no loans have been taken up since.
Consolidated equity as of June 30, 2018, including proceeds from the directed new issue completed in June, was MSEK 383.0 (488.9).
Establishment of the European commercial organization progressed and a wholly owned subsidiary has been set up in France.
Camurus' share is listed on Nasdaq Stockholm.
In June, Camurus completed a directed share and 1,100,000 new shares were issued. At the end of the period, the total number of shares and votes was 38,381,486 (37,281,486).
Camurus has three subscription warrant programs
active for the company's employees.
In accordance with a decision by the Shareholder's General Meeting in May 2016, an incentive program, TO2016/2019, was introduced. 550 000 warrants were issued, which give the right to subscribe for an equal number of shares during the period May 15, 2019 – December 15, 2019. However, transfer of subscription warrants to future employees was not allowed after the Annual General Meeting 2017. In all 47 employees have joined the program and subscribed for 404,300 warrants. The dilution effect on a maximum utilization of subscribed warrants corresponds to 1.8% of the share capital and the voting rights. During the quarter, earnings after tax were negatively impacted by MSEK 0.4 related to the stay-on bonus the participants receive as part of the program. 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 were issued, which give the right to subscribe for an equal number of shares during the period May 15, 2020 – December 15, 2020. However, transfer of subscription warrants to future employees was not allowed after the Annual General Meeting 2018. 44 employees have joined the program and subscribed for 658,932 warrants. The dilution effect on a maximum utilization of subscribed warrants corresponds to 1.8% of the share capital and the voting rights. During the quarter, earnings after tax were negatively impacted by MSEK 0.8 related to the stay-on bonus the participants receive as part of the program. Warrant program TO2018/2021
In accordance with a decision by the Shareholder's General Meeting in May 2018, an incentive program, TO2018/2021, was introduced. 1,000,000 warrants were issued, which give the right to subscribe for an equal number of shares during the period May 15, 2021 – December 15, 2021. The dilution effect on a maximum utilization of the programs corresponds to 2.7% of the
share capital and the voting rights. As of 30 June, 2018, 42 employees had joined the program and subscribed for 523,900 warrants. During the quarter, earnings after tax were negatively impacted by MSEK 2.3 related to the stay-on bonus the participants receive as part of the program.
FDA accepts complete response and issues user fee (PDUFA) goal date of December 26, 2018.
Revenues for the quarter amounted to MSEK 11.0 (19.4) and the result after tax was MSEK -68.2 (-45,3).
On June 30, 2018, equity in the Parent Company amounted to MSEK 364.6 (472.3) including proceeds from the directed new share issue that was completed in June. At end of period the issue was registered but not paid.
Total assets at the end of the period was MSEK 469.5 (557,7) of which MSEK 189.3 (413.2) were cash and cash equivalents.
At the end of the period, Camurus had 76 (66) employees, of whom 52 (47) were within research and development, 15 (11) within business development and marketing and sales, while 8 (7) were within administration. The full time equivalent employees (FTEs) during the quarter amounted to 67 (62).
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 2018.
This report has not been reviewed by the company's auditor.
For further information, please contact: Fredrik Tiberg, President & CEO Tel.: +46 46 286 46 92, e-mail: [email protected]
Lund, Sweden, July 16, 2018 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 16, 2018
Camurus AB
Per-Olof Wallström Chairman of the Board
Martin Jonsson Board Member
Kerstin Valinder Strinnholm Board Member
Per-Anders Abrahamsson Board Member
Behshad Sheldon Board Member
Marianne Dicander Alexandersson Board Member
Fredrik Tiberg President and CEO, Board Member
This interim report has not been reviewed by the company's auditors.
CAMURUS INTERIM REPORT SECOND QUARTER 2018 12
| KSEK | Note | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|---|
| Net sales | 3 | 7,315 | 19,138 | 21,954 | 36,330 | 54,308 |
| Cost of goods sold | -1,217 | -1,101 | -2,764 | -1,132 | -1,356 | |
| Gross profit | 6,098 | 18,037 | 19,190 | 35,198 | 52,952 | |
| Marketing and distribution costs | -24,146 | -14,577 | -41,648 | -21,557 | -45,893 | |
| Administrative expenses | -5,516 | -2,558 | -10,515 | -9,997 | -26,590 | |
| Research and development costs | -57,337 | -59,026 | -94,839 | -113,255 | -222,939 | |
| Other operating income | 46 | 40 | 227 | 40 | 93 | |
| Other operating expenses | -301 | -638 | - | -739 | -1,147 | |
| Operating result | -81,156 | -58,722 | -127,585 | -110,310 | -243,524 | |
| Finance income | 37 | 0 | 77 | 1 | 174 | |
| Finance expenses | -11 | -8 | -18 | -11 | -18 | |
| Net financial items | 26 | -8 | 59 | -10 | 156 | |
| Result before tax | -81,130 | -58,730 | -127,526 | -110,320 | -243,368 | |
| Income tax | 8 | 13,622 | 12,927 | 23,749 | 24,270 | 52,794 |
| Result for the period | 4 | -67,508 | -45,803 | -103,777 | -86,050 | -190,574 |
Total comprehensive income is the same as the result for the period, as the consolidated group contains no items that are recognized under other comprehensive income. Total comprehensive income is attributable to parent company shareholders.
EARNINGS PER SHARE, based on earnings attributable to parent company shareholders for the period (in SEK per share)
| SEK | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Earnings per share before dilution, SEK | -1.81 | -1.23 | -2.78 | -2.31 | -5.11 |
| Earnings per share after dilution, SEK | -1.81 | -1.23 | -2.78 | -2.31 | -5.11 |
Presently, the company has three subscription warrant programs active. For further information see page 9 Camurus' share, and page 21.
ASSETS 490,133 570,403 475,934
| KSEK | Note | 2018-06-30 | 2017-06-30 | 2017-12-31 | KSEK | Note | 2018-06-30 | 2017-06-30 | 2017-12-31 |
|---|---|---|---|---|---|---|---|---|---|
| ASSETS | EQUITY | ||||||||
| Fixed assets | |||||||||
| Equity attributable to parent company | |||||||||
| Intangible assets | shareholder | ||||||||
| Capitalized development expenditure | 15,609 | 17,697 | 16,653 | Share capital | 960 | 932 | 932 | ||
| Other contributed capital | 741,682 | 641,524 | 642,175 | ||||||
| Tangible assets | Retained earnings, including results for the period | -359,651 | -153,597 | -258,107 | |||||
| Equipment | 11,256 | 10,259 | 9,902 | Total equity | 9 | 382,991 | 488,860 | 385,000 | |
| Financial assets | LIABILITIES | ||||||||
| Deferred tax receivables | 8 | 141,431 | 85,954 | 114,997 | |||||
| Total fixed assets | 168,296 | 113,910 | 141,552 | Short-term liabilities | |||||
| Trade payables | 29,186 | 17,133 | 15,086 | ||||||
| Current assets | Income taxes | 1,138 | - | 517 | |||||
| Other liabilities | 6,078 | 4,668 | 2,672 | ||||||
| Inventories | Accrued expenses and deferred income | 70,740 | 59,742 | 72,659 | |||||
| Finished goods | 2,317 | 1,425 | 2,829 | Total short-term liabilities | 107,142 | 81,543 | 90,934 | ||
| Raw materials | 4,004 | 12,623 | 724 | TOTAL EQUITY AND LIABILITIES | 490,133 | 570,403 | 475,934 | ||
| Total inventories | 6,321 | 14,048 | 3,553 | ||||||
| Current receivables | |||||||||
| Registered but unsettled issue payment |
9 | 94,357 | - | - | |||||
| Trade receivables | 2,430 | 12,010 | 5,781 | ||||||
| Other receivables | 6,230 | 3,285 | |||||||
| Prepayments and accrued income | 13,156 | 10,845 | 7,239 | ||||||
| Total current receivables | 5 | 116,423 | 43,133 | 16,305 | |||||
| Cash and cash equivalents | |||||||||
| Total current assets | 199,093 | 413,360 | 314,524 | ||||||
| TOTAL ASSETS | 321,837 | 456,493 | 334,382 |
| Retained | |||||
|---|---|---|---|---|---|
| Share | Other contributed |
earnings, including result |
|||
| KSEK | Note | capital | capital | for the period | Total equity |
| Opening balance 1 January 2017 | 932 | 631,034 | -67,549 | 564,418 | |
| Result for the period and comprehensive income | -86,050 | -86,050 | |||
| Exchange-rate differences | - | - | 2 | 2 | |
| Transactions with shareholders | |||||
| Warrants issued | - | 10,490 | - | 10,490 | |
| Closing balance 30 June 2017 | 932 | 641,524 | 153,597 | 488,860 | |
| Opening balance 1 January 2017 | 932 | 631,034 | -67,549 | 564,418 | |
| Result for the period and comprehensive income | -190,574 | -190,574 | |||
| Exchange-rate differences | - | - | 16 | 16 | |
| Transactions with shareholders | |||||
| Warrants issued | - | 11,141 | - | 11,141 | |
| Closing balance 31 December 2017 | 932 | 642,175 | -258,107 | 385,000 | |
| Opening balance 1 January 2018 | 932 | 642,175 | -258,107 | 385,000 | |
| Result for the period and comprehensive income | -103,777 | -103,777 | |||
| Exchange-rate differences | - | - | 197 | 197 | |
| Transactions with shareholders | |||||
| Directed share issue | 28 | 102,272 | - | 102,300 | |
| Issuance costs, net after deferred tax | - | -7,456 | - | -7,456 | |
| Warrants issued | - | 6,726 | - | 6,726 | |
| Closing balance 30 June 2018 | 9 | 960 | 743,717 | -361,687 | 382,991 |
| KSEK Note |
2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating result before financial items |
-81,156 | -58,722 | -127,585 | -110,310 | -243,524 |
| Adjustment for non-cash items 7 |
1,126 | 1,025 | 2,322 | 2,038 | 4,104 |
| Interest received | 37 | - | 77 | 1 | 174 |
| Interest paid | -11 | -8 | -18 | -11 | -18 |
| Income taxes paid | - | - | - | - | 0 |
| -80,004 | -57,705 | -125,204 | -108,282 | -239,264 | |
| Increase/decrease in inventories | -3,957 | -5,796 | -2,768 | -1,667 | 8,827 |
| Increase/decrease in trade receivables | -1,098 | -5,322 | 3,413 | -3,706 | 2,523 |
| Increase/decrease in other current receivables | -7,186 | 65 | -10,790 | 3,239 | 9,788 |
| Increase/decrease in trade payables | 16,607 | 4,081 | 14,100 | -426 | -2,474 |
| Increase/decrease in other current operating liabilities | 3,542 | 4,043 | 2,108 | 6,612 | 17,532 |
| Cash flow from changes in working capital | 7,908 | -2,929 | 6,063 | 4,052 | 36,196 |
| Cash flow from operating activities | -72,096 | -60,634 | -119,141 | -104,230 | -203,068 |
| Investing activities | |||||
| Acquisition of tangible assets | -1,758 | -299 | -2,424 | -1,494 | -2,143 |
| Cash flow from investing activities | -1,758 | -299 | -2,424 | -1,494 | -2,143 |
| Financing activities | |||||
| Warrants issued | 6,726 | 10,490 | 6,726 | 10,490 | 11,141 |
| Cash flow from financing activities | 6,726 | 10,490 | 6,726 | 10,490 | 11,141 |
| Net cash flow for the period | -67,128 | -50,443 | -114,839 | -95,234 | -194,070 |
| Cash and cash equivalents at beginning of period | 266,633 | 463,804 | 314,524 | 508,594 | 508,594 |
| Translation difference in cash flow and liquid assets | -412 | - | -592 | - | - |
| Cash and cash equivalents at the end of period | 199,093 | 413,360 | 199,093 | 413,360 | 314,524 |
| KSEK Note |
2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Net sales | 11,011 | 19,423 | 28,276 | 36,760 | 64,640 |
| Cost of goods sold | -1,217 | -1,100 | -2,764 | -1,132 | -1,356 |
| Gross profit | 9,794 | 18,323 | 25,512 | 35,628 | 63,284 |
| Marketing and distribution costs | -11,854 | -7,670 | -22,127 | -14,789 | -30,234 |
| Administrative expenses1) | -22,995 | -9,601 | -38,690 | -17,183 | -54,689 |
| Research and development costs | -56,828 | -58,504 | -93,795 | -112,211 | -220,849 |
| Other operating income | 15 | 30 | 270 | 30 | 61 |
| Other operating expenses | -324 | -637 | - | -739 | -1,147 |
| Operating result | -82,192 | -58,061 | -128,830 | -109,265 | -243,574 |
| Interest income and similar items | 37 | - | 77 | 1 | 174 |
| Interest expense and similar items | -11 | -7 | -18 | -11 | -18 |
| Result after financial items | -82,166 | -58,068 | -128,771 | -109,274 | -243,418 |
| Appropriations | - | - | - | - | - |
| Result before tax | -82,166 | -58,068 | -128,771 | -109,274 | -243,418 |
| Tax on profit for the period 8 |
13,919 | 12,775 | 24,102 | 24,040 | 52,853 |
| Result for the period | -68,247 | -45,293 | -104,669 | -85,234 | -190,565 |
1) The increase in cost compared to previous year, is mainly related to group internal recharges.
Total comprehensive income is the same as profit/loss for the period, as the parent company contains no items that are recognized under other comprehensive income.
| KSEK | Note | 2018-06-30 | 2017-06-30 | 2017-12-31 | KSEK | Note 2018-06-30 |
2017-06-30 | 2017-12-31 |
|---|---|---|---|---|---|---|---|---|
| ASSETS | EQUITY AND LIABILITES | |||||||
| Fixed assets | Restricted equity | |||||||
| Restricted equity (38 381 486 shares) |
960 | 932 | 932 | |||||
| Tangible fixed assets | Statutory reserve | 11,327 | 11,327 | 11,327 | ||||
| Equipment | 11,078 | 10,259 | 9,725 | Total restricted equity | 12,287 | 12,259 | 12,259 | |
| Financial fixed assets | Unrestricted equity | |||||||
| Interest in Group companies | 1,545 | 816 | 1,545 | Retained earnings | -253,159 | -62,595 | -62,594 | |
| Deferred tax assets | 8 | 145,631 | 90,614 | 119,426 | Share premium reserve | 708,000 | 607,908 | 608,560 |
| Total fixed assets | 158,254 | 101,689 | 130,696 | Result for the period |
-102,566 | -85,234 | -190,565 | |
| Total unrestricted equity | 352,275 | 460,080 | 355,401 | |||||
| Current assets | TOTAL EQUITY | 364,562 | 472,339 | 367,660 | ||||
| Inventories | LIABILITIES | |||||||
| Finished goods | 2,317 | 1,425 | 2,829 | Untaxed reserves | ||||
| Raw materials | 4,004 | 12,623 | 724 | Depreciation/amortization in excess of plan | 3,486 | 3,486 | 3,486 | |
| Total inventories | 6,321 | 14,048 | 3,553 | Total untaxed reserves | 3,486 | 3,486 | 3,486 | |
| Current receivables | Long-term liabilities | |||||||
| Registered but unsettled issue payment |
9 | 94,357 | - | - | Liability to subsidiaries | 571 | 571 | 571 |
| Trade receivables | 2,368 | 12,010 | 5,781 | Total long-term liabilities | 571 | 571 | 571 | |
| Other receivables | 5,894 | 6,000 | 3,040 | |||||
| Prepayments and accrued income | 12,961 | 10,807 | 7,202 | Short-term liabilities | ||||
| Total current receivables | 115,580 | 28,817 | 16,022 | Liabilities to Group companies | 2,905 | 309 | 3,769 | |
| Trade payables | 28,845 | 16,721 | 14,431 | |||||
| Cash and bank deposits | 189,302 | 413,170 | 309,821 | Other liabilities | 4,728 | 4,668 | 2,053 | |
| Total current assets | 311,203 | 456,035 | 329,397 | Accrued expenses and deferred income | 64,359 | 59,630 | 68,123 | |
| TOTAL ASSETS | 469,457 | 557,724 | 460,093 | Total short-term liabilities | 100,837 | 81,328 | 88,376 | |
| TOTAL EQUITY AND LIABILITY | 469,457 | 557,724 | 460,093 |
| MSEK | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Net sales | 7.3 | 19.1 | 22.0 | 36.3 | 54.3 |
| Operating result | -81,2 | -58.7 | -127.6 | -110.3 | -243.5 |
| Result for the period | -67.5 | -45.8 | -103.8 | -86.0 | -190.6 |
| Cash flow from operating activities | -72.1 | -60.6 | -119.1 | -104.2 | -203.1 |
| Cash and cash equivalents | 199.1 | 413.4 | 199.1 | 413.4 | 314.5 |
| Equity | 383.0 | 488.9 | 383.0 | 488.9 | 385.0 |
| Equity ratio in Group, percent | 78% | 86% | 78% | 86% | 81% |
| Total assets | 490.1 | 570.4 | 490.1 | 570.4 | 475.9 |
| Average number of shares, before dilution | 37,305,930 | 37,281,486 | 37,293,641 | 37,281,486 | 37,281,486 |
| Average number of shares, after dilution*) | 38,567,080 | 37,882,454 | 38,455,285 | 37,784,664 | 38,058,298 |
| Earnings per share before dilution, SEK | -1.81 | -1.23 | -2.78 | -2.31 | -5.11 |
| Earnings per share after dilution, SEK*) | -1.81 | -1.23 | -2.78 | -2.31 | -5.11 |
| Equity per share before dilution, SEK | 10.26 | 13.11 | 10.26 | 13.11 | 10.33 |
| Equity per share after dilution, SEK*) | 9.93 | 12.90 | 9.93 | 12.94 | 10.12 |
| Number of employees at the end of period | 76 | 66 | 76 | 66 | 71 |
| Number of employees in R&D at the end of period | 52 | 47 | 52 | 47 | 48 |
| R&D costs as a percentage of operating expenses | 66% | 78% | 65% | 78% | 75% |
*) The dilution effect is calculated according to IAS 33
Cash and cash bank balances
Equity ratio, % Equity divided by total capital
Average number of shares, before dilution Weighted average number of shares before adjustment for dilution effect of net shares
Average number of shares, after dilution Weighted average number of shares adjustment for the dilution effect of new shares
Earnings per share before dilution, SEK Result divided by the weighted average number of shares outstanding before dilution
Earnings per share after dilution, SEK Result divided by the weighted average number of shares outstanding after dilution
Equity per share before dilution, SEK
Equity divided by the weighted number of shares at the end of the period before dilution
Equity divided by the weighted number of shares at the end of the period after dilution
Research and development costs divided by operating expenses (marketing and distribution costs, administrative expenses and research and development costs)
Camurus AB, Corp. ID no. 556667-9105 is the parent company of the Camurus Group. Camurus AB's registered office is based in Lund, Sweden, at Ideon Science Park, 223 70 Lund. Camurus AB Group's interim report for the second quarter 2018 was approved for publication in accordance with a decision by the Board of Directors on July 16, 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
The most important accounting policies that are applied in the preparation of these consolidated financial statements are detailed below and are the same and consistent with those used in the preparation of Annual Report 2017, see camurus.com/Investors/Financial Reports. In addition, as of January 1, 2018 the new standards IFRS 9 and IFRS 15 entered into force. As previously mentioned, the transition has not had any effect. Neither this report or the interim period 2018 have been affected. Presentation of the Group's full accounting principles will be made in the Annual Report 2018.
The Group has begun its analysis of possible transition effects of IFRS 16, but this is still in the early stages. More information will be presented in future interim reports and annual reports for 2018.
New or revised IFRS standards that have come into force have not had any material impact on the Group.
The parent company applies accounting policies that differ from those of the Group in the cases stated below.
All expenses that relate to the development of internally generated intangible assets are recognized as expenses as they arise.
Interests in subsidiaries are reported at cost, less any impairment losses. The cost includes acquisition-related expenses and any additional considerations.
When there is an indication that interests in subsidiaries have decreased in value, a calculation is made of the recoverable amount. If this amount is lower than the reported amount, an impairment is carried out.
Impairment losses are recognized under the item "Result from interest in Group companies".
Group contributions paid by the parent company to subsidiaries and Group contributions received from subsidiaries by the parent company are recognized as appropriations.
IAS 39 is not applied in the parent company and financial instruments are measured at cost.
Camurus has two long-term incentive programs active for the company's employees. The warrants are valued by an independent institute in accordance with Black&Scholes model and are acquired by the participants at market value. As part of the program, the participants receive a threepiece stay-on bonus from the company in form of gross salary additions equivalent to the amount paid by the participant for the subscription warrants. As the stayon bonus is conditional on continued employment, costs including social security fee, are based on how much has been earned, and are expensed over the vesting period. Expenses are recognized as personnel cost in the income statement
Maximum 550,000 warrants could be issued and the program was introduced in accordance with a decision by the Annual General Meeting in May 2016. Warrant program TO2017/2020 Maximum 750,000 warrants can be issued and the program was introduced in accordance with a decision by the Annual General Meeting in May 2017. Warrant program TO2018/2021 Maximum 1,000,000 warrants can be issued and was introduced in accordance with a decision by the Annual
General Meeting in May 2018.
The highest executive decision maker is the function responsible for allocating resources and assessing the operating segments results. In the Group this function is identified as the CEO based on the information he manages. As the operations in the Group, i.e. the development of pharmaceutical products based on Camurus' technology platform, is organized as an integrated unit, with similar risks and opportunities for the products and services produced, the entire Group's business constitutes one operating segment. The operating segment is monitored in a manner consistent with the internal reporting provided to the chief operating decision maker. In the internal reporting to the CEO, only one segment is used.
To follow is a breakdown of revenues from all products and services.
| KSEK | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Sales of development related goods and services | 4,072 | 14,747 | 7,903 | 28,675 | 41,394 |
| Milestone payments | - | - | 7,840 | 2,205 | 7,025 |
| Licensing revenues | - | 3,079 | - | 3,914 | 3,582 |
| Other | 3,243 | 1,312 | 6,211 | 1,536 | 2,307 |
| Total | 7,315 | 19,138 | 21,954 | 36,330 | 54,308 |
Revenues from external customers are allocated by country, based on where the customers are located.
| KSEK | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Europe | 719 | 5,702 | 1,251 | 7,076 | 7,229 |
| (of which Sweden) | (100) | (9) | (221) | (68) | (239) |
| North America | 4,261 | 12,989 | 15,571 | 28,659 | 41,350 |
| Other geographical areas | 2,335 | 447 | 5,132 | 595 | 5,729 |
| Total | 7,315 | 19,138 | 21,954 | 36,330 | 54,308 |
Revenues during the quarter of approximately MSEK 4.1 (13.4) relate to one single external customer.
Earnings per share before dilution is calculated by dividing the result attributable to shareholders of the parent company by a weighted average number of ordinary shares outstanding during the period. During the period, no shares held as treasury shares by the parent company have been repurchased.
| KSEK | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders | -67,508 | -45,803 | -103,777 | -86,050 | -190,574 |
| Total | -67,508 | -45,803 | -103,777 | -86,050 | -190,574 |
| Weighted average number of ordinary shares outstanding (thousands) |
37,306 | 37,281 | 37,294 | 37,281 | 37,281 |
In order to calculate earnings per share after dilution, the number of existing ordinary shares is adjusted for the dilutive effect of the weighted average number of outstanding ordinary shares. The parent company has one category of ordinary shares with anticipated dilution effect in the form of warrants. For warrants, a calculation is made of the number of shares that could have been purchased at fair value (calculated as the average market price for the year for the parent company's shares), at an amount corresponding to the monetary value of the subscription rights linked to outstanding warrants. The number of shares calculated as above are compared to the number of shares that would have been issued assuming the warrants are exercised.
| KSEK | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders | -67,508 | -45,803 | -103,777 | -86,050 | -190,574 |
| Total | -67,508 | -45,803 | -103,777 | -86,050 | -190,574 |
| Weighted average number of ordinary shares outstanding (thousands) |
37,306 | 37,281 | 37,294 | 37,281 | 37,281 |
| Adjustments: | |||||
| - Warrants (thousands) |
1,261 | 601 | 1,161 | 504 | 777 |
| - Share issues (thousands) |
- | - | - | - | - |
| Weighted average number of ordinary shares in calculation of earnings per share after dilution (thousands) |
38,567 | 37,882 | 38,455 | 37,785 | 38,058 |
All of the Group's financial instruments that are measured at amortized cost are short-term and expire within one year. The fair value of these instruments is deemed to correspond to their reported amounts, since discounting effects are minimal.
There were no related party transactions during the period.
No receivables or liabilities existed as of June 30, 2018.
| Carrying amount, KSEK | 2018-06-30 | 2017-06-30 | 2017-12-31 |
|---|---|---|---|
| Loans and receivables | |||
| Trade receivables | 2,368 | 12,010 | 5,781 |
| Receivables from Group companies | - | - | - |
| Other receivables | - | - | - |
| Cash and cash equivalents | 199,093 | 413,360 | 314,524 |
| Total | 201,461 | 425,370 | 320,305 |
| Other liabilities | |||
| Other financial liabilities | - | - | - |
| Liabilities to Group companies | - | - | - |
| Trade payables | 29,186 | 17,133 | 15,086 |
| Other current liabilities | 191 | 191 | 191 |
| Total | 29,377 | 17,324 | 15,277 |
Adjustment for non-cash items:
Tax for the quarter amounted to MSEK 13.6 (24.3), primary attributable to the negative result.
The change in equity for the quarter is mainly attributable to the loss and the directed share issue completed in June.
| KSEK | 2018 Apr-Jun |
2017 Apr-Jun |
2018 Jan-Jun |
2017 Jan-Jun |
2017 Jan-Dec |
|---|---|---|---|---|---|
| Depreciation | 1,077 | 1,025 | 2,125 | 2,038 | 4,088 |
| Exchange-rate differences | 49 | - | 197 | - | 16 |
| Total | 1,126 | 1,025 | 2,322 | 2,038 | 4,104 |
CAMURUS AB | Ideon Science Park, SE-223 70 Lund, Sverige T +46 46 286 57 30 | F +46 46 286 57 39 | [email protected] | camurus.com
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