Interim / Quarterly Report • Nov 8, 2016
Interim / Quarterly Report
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| Full Year Report 2016 | 16 February 2017 |
|---|---|
| Annual Report 2016 | 30 March 2017 |
| Q1 2017 | 3 May 2017 |
| Annual General Meeting 2017 |
3 May 2017 |
"All patients completed treatment in the pivotal Phase 3 opioid dependence trial and we are excited about receiving the study results. In parallel, we are preparing for submissions of marketing approval applications in Europe and the US during $2017''$
Camurus is a Swedish research-based pharmaceutical company committed to developing and commercializing innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the proprietary FluidCrystal® drug delivery technologies and an extensive R&D expertise. The company's share is listed on Nasdaq Stockholm under the ticker "CAMX".
Good progress was made during the third quarter. All patients completed treatment in the pivotal Phase 3 opioid dependence trial and we are excited about receiving the study results. In parallel, we are preparing for submissions of marketing approval applications in Europe and the US during 2017. Another highlight during the quarter was the initiation of a new Phase 3 trial of CAM2038 for treatment of chronic pain. This is an area with an unmet need for new, effective and safe treatment solutions that have reduced risks of misuse. overdosing and diversion.
Our extensive study program on CAM2038 led to the presentation of three scientific papers at the International Society for Addiction Medicine (ISAM) meeting in Montreal, October 20-22, 2016. Professor Sharon Walsh, MD/PhD. University of Kentucky, presented new data from a pivotal Phase 2 trial showing how CAM2038 blocks subjective opioid effects of randomized hydromorphone injections and discussed the relevance of the results for clinical practice. I presented data pharmacokinetics and safety of CAM2038 from Phase 1 trials in healthy volunteers under naltrexone blockade, while study design and protocol of the ongoing Phase 3 program were presented by Assoc. Professor Michelle Lofwall. MD. Medical Director of UK College of Medicine Straus Clinic, University of Kentucky. The presentations were timely, in advance of the forthcoming topline Phase 3 results. In parallel, preparations are ongoing for submissions of marketing approval applications for CAM2038 for treatment of opioid use disorder. We have also initiated a new Phase 3 trial of CAM2038 for treatment of chronic pain and thereby taken a first step towards expanding future indication areas for the product for pain. In general, we see a
significant potential for innovative, effective and non-abusable pain treatments.
During the period, we announced positive results from a Phase 2 trial of our long-acting octreotide formulation CAM2029 for treatment of patients with neuroendocrine tumors (NET) or acromegaly. The product candidate was well tolerated and the treatment effects were comparable or better in some patients after switching from Sandostatin® LAR® to CAM2029. The results are promising and we are looking forward to Novartis initiating the Phase 3 trials in acromegaly and NET patients during 2017.
In the early pipeline, a clinical trial application has been submitted for a Phase 1 trial of three new product candidates -CAM2047, CAM2048 and CAM2058 - targeting indications of nausea and vomiting and/or postoperative pain. This study is designed to assess pharmacokinetics, pharmacodynamics and safety and will provide important insight and quidance for the further clinical development of these assets. After the period we announced the expansion of the collaboration and license agreement with Braeburn Pharmaceuticals for the further development and commercialization in North America of CAM2058, a combination product of buprenorphine and granisetron for treatment of postoperative pain, nausea and vomiting.
With regards to our ongoing early stage collaborations, we were pleased to note good progress by our partner Rhythm in relation to their development of setmelanotide for treatment of rare genetic obesity disease. In addition to the publication of promising Phase 2 data in New England Journal of Medicine, the investigational drug, setmelanotide, was during the period granted Breakthrough Therapy designation for POMS deficiency obesity and Orphan Designation for Prader-Willis Syndrome. In our collaboration of the development of a weekly semelanotide FluidCrystal®, final preparations for a first clinical study are being finalized
We have also completed the initial stage of building our own commercial organization. Key leadership roles and specialist functions are now in place and I am delighted that in a short period we have established a strong core team of internationally experienced and entrepreneurial professionals and experts. Meanwhile, our partner Braeburn Pharmaceuticals has been expanding their US commercial footprint after the recent successful market approval of Probuphine® implant by the US FDA. Together, we have built a strong foundation for the planned approvals of CAM2038 in the US and Europe during 2018.
Fredrik Tiberg, President and CEO
• Expansion of collaboration and license agreement with Braeburn Pharmaceuticals with new combination product CAM2058 for treatment of postoperative pain.
Camurus is a research-based pharmaceutical company with a focus on the development and commercialization of new and innovative pharmaceuticals for serious and chronic conditions. where there are clear medical needs and the potential to significantly improve treatment. For the development of new drug candidates Camurus utilizes its own proprietary formulation technology, for example, the long-acting injection depot FluidCrystal®. New proprietary medicines with improved properties and treatment outcomes are developed by combining the company's patented drug delivery technologies with active ingredients with documented safety and efficacy profiles. These are developed with significantly lower cost and risk, compared with the development of completely new pharmaceuticals. Camurus' development pipeline contains product candidates for treatment of cancer and the side effects of cancer treatment. endocrine diseases, pain and addiction, see figure. A summary and status update on the different projects is given below.
CAM2038 - opioid dependence
CAM2038 includes subcutaneous weekly and monthly depots of
buprenorphine, developed by Camurus and its partner Braeburn Pharmaceuticals for treatment
CINV - Chemotherapy induced nausea PONV-Postoperative nausea and vomiting
of opioid dependence. CAM2038, granted FastTrack status by US FDA, is developed to address a serious condition and key
shortcomings of currently available medications, including limited patient compliance with frequent relapses and problems of misuse, abuse and diversion of current daily medications. To date, the CAM2038 products have been evaluated in four Phase 1/2 clinical trials. Good safety profiles as well as pharmacokinetic and pharmacodynamic properties suitable for weekly and monthly dosing have been documented in the clinical trials. Three more trials, including two Phase 3 studies, are currently ongoing.
During May we announced positive results from a pivotal Phase 2 opioid challenge trial. The results show that treatment with CAM2038 effectively blocks subjective opioid effects of injected hydromorphone, which means that CAM2038 can protect patients from relapse to abuse of heroin and prescription opioids. In the ongoing pivotal Phase 3 efficacy trial of CAM2038 all patients have now completed treatment. Top level data from this randomized, double-blind, double-dummy, activecontrolled, 24-week efficacy trial is due during November. In parallel, the long-term safety Phase 3 trial of CAM2038 is also under completion with the last patients last visit meeting scheduled end of Q1 2017. Furthermore, a Phase 2 study evaluating pharmacokinetics during repeated dosing of CAM2038 is ongoing (see chronic pain section). These studies are part of the registration program, which has been discussed and alianed with both European and US regulatory authorities.
CAM2038 weekly and monthly depots are also being developed for treatment of chronic pain, with the purpose of providing round-the-clock pain relief, while decreasing the risks of respiratory depression and fatal overdoses associated with full $\mu$ -opioid agonists, such as morphine, oxycodone and fentanyl. The properties of CAM2038 conform to the quidelines and recommendations for treatments of chronic pain, i.e. the combination of stable efficacious analgesia with a reduced risk of misuse, abuse and illicit diversion.
In the ongoing Phase 2 trial of CAM2038 in patients with chronic pain, pharmacokinetics and safety after repeated dosing of the CAM2038 weekly and monthly products are being evaluated. After the period, the trial has been expanded with one further dose group in order to evaluate equilibrium kinetics and effect on pain in a higher dose. The results from the first dose group are expected in the fourth quarter 2016 and data from the new dose group is expected after year end 2016. Furthermore, a Phase 3 pivotal trial for CAM2038 for treatment of chronic lower back pain has been initiated.
CAM2029 is a subcutaneous monthly depot of octreotide under development for the treatment of patients with acromegaly or neuroendocrine tumors (NET). CAM2029 is being developed by Novartis as a potential treatment alternative to the current market leading product Sandostatin® LAR®, with global sales of USD 1.63 billion in 2015. CAM2029 is administered as a ready-touse subcutaneous injection, whereas Sandostatin® LAR® has to be prepared from a powder in a process consisting of six steps before being injected intramuscularly by a healthcare professional. CAM2029 has in clinical trials demonstrated about a 500 percent higher bioavailability of octreotide compared with Sandostatin® LAR®, which gives potential for improved treatment effects in patients who do not respond satisfactorily to current treatments
Camurus and Novartis announced positive Phase 2 trial results regarding pharmacokinetics, safety and maintenance of disease control in patients with acromegaly and NET previously treated with Sandostatin® LAR®. The disease control was evaluated by the control of carcinoid symptoms in NET patients and plasma levels of insulin growth factor-1 (IGF-1) and growth hormone (GH) in acromegaly patients. Results will be presented in a future
publication. In parallel, Novartis is completing the preparations of Phase 3 trials of CAM2029, planned to start 2017.
CAM2032 is a subcutaneous depot product that is being developed by Camurus for treatment of prostate cancer. Other possible indications include precocious puberty and endometriosis. The product is based on the active ingredient leuprolide, belonging to the class of gonadotropin releasing hormone analogs. CAM2032 is as the first product in its class developed for easy subcutaneous injection by patients themselves, in the form of a small volume injection with a duration of one month.
The positive results from the completed Phase 2 study of CAM2032 in patients with advanced metastatic prostate cancer announced in June, are being compiled for a planned publication. In parallel, discussions on potential partnerships are ongoing.
CAM4071 is a product candidate in clinical development under the option, collaboration and licensing agreement with Novartis. The product is a long-acting formulation of an undisclosed peptide based on the FluidCrystal® Injection depot.
A Phase 1 trial of pharmacokinetics and pharmacodynamics has been completed and is being reported.
Several new product candidates are being evaluated in pharmaceutical and preclinical studies, supported by initial market research. The development includes formulation optimization with respect to release performance, stability and pharmacological properties, per predefined target product profiles.
During the period, we have completed supporting toxicology studies for two product candidates. GMP manufacturing of investigational drug products of CAM2047, CAM2048, and CAM2058 is completed in preparations for a Phase 1 clinical trial that was initiated after the end of the period. These drug candidates are based on Camurus' FluidCrystal® injection depot and are being developed for treatment of chemotherapy induced nausea and vomiting (CAM2047), pain (CAM2048) and combined treatment of postoperative pain and nausea and vomiting (CAM2058). Results from the first clinical study are expected during the first quarter 2017.
Camurus is also involved in several collaboration projects with international pharmaceutical companies, where new product candidates based on Camurus' formulation technology and the partner company's patented active ingredient are evaluated. These collaborations often involve formulation development and assessments with respects to pre-specified technical and market related objectives. The time frame of these feasibility studies is typically 6-12 months. After successful evaluations, product development can continue under a license agreement, with opportunities for future development and commercial milestone payments as well as royalty on future sales.
Several project collaborations are ongoing with international pharmaceutical companies, based on Camurus' FluidCrystal® technologies and the partners' proprietary drug substance. These projects target different indications such as cancer, obesity, diabetes and viral infection. Early this year, a license agreement was signed with the Boston-based biotech company Rhythm, regarding the use of Camurus FluidCrystal® injection depot for developing a once-weekly formulation of setmelanotide (RM-493), a novel melanocortin-4 receptoragonist (MC4R) for treatment of genetic obesity. GMPmanufacturing is ongoing for the start of a clinical Phase 1 trial in 2017
episil* is a medical device for treatment of inflammatory and painful conditions in the oral cavity. The product provides effective pain relief and works by spreading and adhering to the oral mucosa as a thin bioadhesive film, which acts as a longacting protective barrier that reduces pain and protection of sore and inflamed mucosal surfaces, such as caused by oral mucositis, a common and serious side effect of cancer treatment, episif transforms into a protective layer of gel in contact with the buccal membrane, offering effective pain relief for up to 8 hours.
Camurus partner Solasia Pharma continues its market registration process for episil® in China and Japan. A new distribution and license agreement for episil® in the US was signed with Princeton based R-Pharm US in April and the product was launched in September.
Revenues during the third quarter amounted to MSEK 30.5 (37.2), generated from license agreements, project activities and product sales. License and milestone payments vary between quarters as potential new agreements may be entered and development milestones may be achieved.
Marketing, business development and distribution costs during the third quarter, were MSEK 5.8 (5.3).
Administrative expenses amounted to MSEK 4.4 (0.9). The difference compared to the same period last year is mainly related to a retroactive reallocation between administrative expenses, marketing and distribution costs and research and development (R&D) costs.
R&D costs were MSEK 36.7 (38.3), including depreciation and amortization of tangible and intangible assets.
Other operating incomes/expenses mainly consist of currency exchange gains in operational activities of a total of MSEK 0.3 (0.3).
The operating result for the third quarter, before and after items affecting comparability was MSEK-16.6 (-7.1) and MSEK-16.6 (-29.1).
Financial items for the period was MSEK-0.4 (-0.0). Tax for the quarter was MSEK 3.7 (6.4). The difference compared to the previous year is mainly attributable to deferred tax for losses during the quarter.
The result for the period was MSEK-13.2 (-22.7), corresponding to earnings per share of SEK-0,35 (-0.90) before and after dilution.
Cash flow from operating activities, before change in working capital amounted to MSEK-15.9 (-9,5).
Change in working capital was MSEK-14.1 (-14.5).
Cash flow from investing activities was MSEK-1.6 (0.0), and from finance activities to MSEK 0.9 (0.0) in relation to issuance of warrants.
The Company's cash position at the end of the quarter was MSEK 518.2 (112.3). The change relates mainly to proceeds from the listing of Camurus' shares on Nasdag, Stockholm in 2015.
There were no outstanding loans as of September 30, 2016, and no loans have been taken up since.
Consolidated equity as of September 30, 2016, was MSEK 591.5 (103.1). The change is mainly related to issued proceeds from the listing of the Company's shares on Nasdaq Stockholm in 2015.
No acquisitions or divestments have occurred during in the period.
Camurus' share is listed on Nasdag Stockholm since the December 3, 2015. At the end of the period, the total number of shares in the company was 37,281,486 (25,208,560).
In accordance with a decision by a Shareholder's General Meeting in May 2016, an incentive program (TO2016 / 2019) under which a maximum of 550,000 warrants can be issued, was introduced. The dilution of a full utilization of the program corresponds to 1.5% of the share capital and voting rights. The number of warrants that have been issued are 550,000 and which give the right to subscribe for an equal number of shares during the period May 15, 2019 - December 15, 2019. As per September 30, 2016, 383 100 warrants had been subscribed for with an increase in equity of MSEK 0.9 during the third quarter. The total impact on earnings during the period was negative MSEK 0.7 after tax, including stay-on bonuses in the program.
Revenues for the quarter amounted to MSEK 30.5 (37.2) and the result after tax was MSEK-12.8 (-22.3).
On September 30, 2016, equity in the Parent Company amounted to MSEK 574.4 (72.9). The difference compared with the year-earlier period is mainly attributed to issued proceeds from the stock market listing of the company's share.
Total assets at the end of the period was MSEK 635.0 (197.5) of which MSEK 518.2 (112.3) were cash and cash equivalents.
At the end of the period, Camurus had 58 (48) employees, of whom 42 (35) were within research and development. The full time equivalent employees (FTEs) during the quarter was 49 (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 effectrelated risks that can arise in clinical trials, regulatory risks relating to non-approval or delays of clinical trial applications and market approvals, and commercial risks relating to the sale of proprietary and competing products and their development on the market, as well as IP risks relating to approval of patent applications and patent protection. In addition, there are risks relating to the development, strategy and management decisions of Camurus' partners.
Camurus pursues operations and its business on the international market and the Company is therefore exposed to currency risks, since revenues and costs arise in different currencies, mainly SEK, EUR and USD.
The Board of Directors has not changed its outlook on future
developments in relation to their outlook published in the interim report for the second quarter 2016.
This report has been reviewed in summary by the company's auditors.
Camurus Annual General Meeting 2017 will be held on Wednesday 3 May, at 17.00 CET, at Elite Hotel Ideon, Scheelevägen 27, Ideon Science Park, 223 63 Lund.
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. November 7, 2016 Camurus AB Board of Directors
We have reviewed the condensed interim financial information (interim report) of Camurus AB (publ) as of 30 September 2016 and the nine-month period then ended. The board of directors and the CEO are responsible for the preparation and presentation of the interim financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
We conducted our review in accordance with the International Standard on Review Engagements ISRE 2410, Review of Interim Report Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing, ISA, and other generally accepted auditing standards in Sweden. The procedures performed in a Teview do not enable us to obtain assurance that we would
become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act, regarding the Group, and with the Swedish Annual Accounts Act, regarding the Parent Company.
Lund, November 7th, 2016 PricewaterhouseCoopers
Ola Bjärehäll
Authorized Public Accountant Auditor in charge
| KSEK | Note | 2016 | 2015 | 2016 | 2015 | 2015 |
|---|---|---|---|---|---|---|
| Jul-Sep | Jul-Sep | Jan - Sep | Jan – Sep | Jan - Dec | ||
| Net sales | 3 | 30,531 | 37,232 | 76,611 | 118,459 | 154,799 |
| Cost of goods sold | $-546$ | $-131$ | $-911$ | $-132$ | $-237$ | |
| Gross profit | 29,985 | 37,101 | 75,699 | 118,327 | 154,562 | |
| Marketing and distribution costs | $-5,762$ | $-5,255$ | $-15,353$ | $-12,425$ | $-19,411$ | |
| Administrative expenses | $-4,392$ | $-925$ | $-13,919$ | $-18,712$ | $-11,934$ | |
| Research and development costs | $-36,702$ | $-38,263$ | $-113,059$ | $-111,940$ | $-153,080$ | |
| Other operating income | 294 | 267 | 43 | 41 | 57 | |
| Other operating expenses | $\Omega$ | $-728$ | $-904$ | $-658$ | ||
| Operating result before items affecting comparability | 7 | $-16,577$ | -7,074 | $-67,316$ | $-25,613$ | -30,464 |
| Items affecting comparability attributable to public listing costs | $\overline{0}$ | 0 | $\overline{0}$ | 0 | $-33,970$ | |
| Items affecting comparability attributable to Share bonus program | $\circ$ | $-22,075$ | $\overline{0}$ | $-138,075$ | $-139,671$ | |
| Operating result | 6 | $-16,577$ | -29,149 | $-67,316$ | $-163,688$ | $-204,104$ |
| Finance income | 8 | |||||
| Finance expenses | $-366$ | $-4$ | $-874$ | $-21$ | $-166$ | |
| Net financial items | $-365$ | $-3$ | $-866$ | $-20$ | -164 | |
| Result before tax | $-16,942$ | -29,152 | $-68,182$ | $-163,708$ | $-204,268$ | |
| Income tax | 9 | 3,727 | 6,414 | 15,000 | 36,016 | 44,727 |
| Result for the period | $-13,215$ | -22,739 | $-53,185$ | -127,692 | -159,542 |
Total comprehensive income is the same as the result for the period, as the consolidated group contains no items that are recognized under other comprehensive income. Total comprehensive income is attributable to parent company shareholders
| SEK | 2016 | 2015 | 2016 | 2015 | 2015 |
|---|---|---|---|---|---|
| Jul-Sep | Jul-Sep | Jan - Sep | Jan – Sep | Jan - Dec | |
| Earnings per share before dilution, SEK | $-0.35$ | -0.90 | $-1.43$ | -5.07 | $-6.02$ |
| Earnings per share after dilution, SEK | $-0.35$ | -0.90 | $-1.43$ | -5.07 | -6.02 |
Since 2013, Camurus had a long-term share based incentive program in place, aimed at employees and Board members and in connection with the listing of the company's share on 3 December 2015 the programme was completed. The impact on previous year's results amounted MSEK 108.9 after tax, with a corresponding increase in equity of MSEK 108.8 and a social security fee liability of MSEK 30.8. For further information please see Note 7. Earnings per share 2015 was effected by -4.32 SEK per share before and after dilution.
| KSEK | Note | 30-09-2016 | 30-09-2015 | 31-12-2015 | KSEK | Note | 30-09-2016 | 30-09-2015 | 31-12-2015 |
|---|---|---|---|---|---|---|---|---|---|
| ASSETS Fixed assets |
EQUITY | ||||||||
| Intangible assets | Equity attributable to parent company shareholder |
||||||||
| Capitalized development expenditure | 19,262 | 21,344 | 20,823 | Share capital | 932 | 630 | 932 | ||
| Other contributed capital | 630,316 | 58,634 | 626,181 | ||||||
| Tangible assets | Retained earnings, including result for the | ||||||||
| Equipment | 7,371 | 6,566 | 6,634 | period | $-39,738$ | 43,801 | 13,444 | ||
| Financial assets | Total equity | 4, 10 | 591,510 | 103,065 | 640,557 | ||||
| Long-term receivables Group companies | $\circ$ | $\overline{0}$ | $\circ$ | ||||||
| Deferred tax receivables | 9 | 54,317 | 27,478 | 39,317 | LIABILITIES | ||||
| Total fixed assets | 80,950 | 55,388 | 66,775 | ||||||
| Long-term liabilities | |||||||||
| Current assets | Deferred tax liability | $\overline{0}$ | $\mathbf 0$ | $\circ$ | |||||
| Total long-term liabilities | $\Omega$ | $\Omega$ | $\mathbf 0$ | ||||||
| Inventories | |||||||||
| Finished goods and goods for resale | 3,957 | 2,570 | 3,241 | Short-term liabilities | |||||
| Liabilities to Group companies | $\Omega$ | 2 | $\Omega$ | ||||||
| Current receivables | Trade payables | 7,832 | 14,177 | 31,832 | |||||
| Receivables from Group companies | $\sqrt{0}$ | $\overline{0}$ | 207 | Income taxes | $\circ$ | 8,936 | 9,917 | ||
| Trade receivables | 17,408 | 27,792 | 8,917 | Other liabilities | 1,933 | 1,292 | 88,088 | ||
| Other receivables | 3,669 | 2,149 | 5,500 | ||||||
| Prepayments and accrued income | 24,740 | 9,516 | 15,613 | Accrued expenses and deferred income | 47,698 | 82,290 | 45,954 | ||
| Cash and cash equivalents | 518,248 | 112,347 | 716,096 | Total short-term liabilities | 57,462 | 106,697 | 175,791 | ||
| TOTAL EQUITY AND LIABILITIES | 648,972 | 209,762 | 816,349 | ||||||
| Total current assets | 568,022 | 154,374 | 749,574 | ||||||
| TOTAL ASSETS | 648,972 | 209,762 | 816,349 |
| Other contributed |
Retained earnings, including result for the |
Total | |||
|---|---|---|---|---|---|
| KSEK | Note | Share capital | capital | period | equity |
| Opening balance 1 January 2015 | 630 | 58,634 | 64,193 | 123,457 | |
| Result for the period and comprehensive income | $-127.692$ | $-127,692$ | |||
| Transaction with shareholders | |||||
| Share bonus program for personnel and Board members | 107,300 | 107,300 | |||
| Closing balance 30 September 2015 | 630 | 58,634 | 43,801 | 103,065 | |
| Opening balance 1 January 2015 | 630 | 58,634 | 64,193 | 123,457 | |
| Result for the period and comprehensive income | $-159,542$ | $-159,542$ | |||
| Transactions with shareholders | |||||
| Share bonus program for personnel and Board members | 47 | 108.793 | 108,840 | ||
| Direct share issue to principal owner | 11 | 23,879 | 23,890 | ||
| Direct share issue, public listing | 244 | 554,756 | 555,000 | ||
| Issuance cost, net after deferred tax | $-11,088$ | $-11,088$ | |||
| Closing balance 31 December 2015 | 932 | 626,181 | 13,444 | 640,557 | |
| Opening balance 1 January 2016 | 932 | 626,181 | 13,444 | 640,557 | |
| Result for the period and comprehensive income | $-53,182$ | $-53,182$ | |||
| Transactions with shareholders | |||||
| Warrants issued | 4,135 | 4,135 | |||
| Closing balance 30 September 2016 | 4,10 | 932 | 630,316 | $-39,738$ | 591,510 |
| KSEK Note |
2016 Jul-Sep |
2015 Jul-Sep |
2016 Jan-Sep |
2015 Jan-Sep |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating profit/loss before financial items | $-16,577$ | $-29,149$ | $-67,316$ | $-163,688$ | $-204,104$ |
| Adjustments for non-cash items | 8 993 |
19,886 | 2,679 | 109,888 | 112,345 |
| Interest received | $\Omega$ | 8 | |||
| Interest paid | $-365$ | $-4$ | $-874$ | $-21$ | $-166$ |
| Income taxes paid | $\Omega$ | $-212$ | $-9,917$ | $-664$ | 317 |
| $-15,949$ | $-9,478$ | $-75,420$ | $-54,484$ | $-91,606$ | |
| Increase/decrease in inventories | $-808$ | $-870$ | $-716$ | $-1,868$ | $-2,539$ |
| Increase/decrease in trade receivables | $-6,661$ | $-16,381$ | $-8,491$ | $-21,673$ | $-2,800$ |
| Increase/decrease in other current receivables | $-7,626$ | $-491$ | $-7,090$ | 1,143 | $-8,511$ |
| Increase/decrease in trade payables | 261 | 1,821 | $-24,000$ | 4,239 | 21,893 |
| Increase/decrease in other current operating liabilities | 775 | 1,427 | $-84,411$ | 27,448 | 77,906 |
| Cash flow from changes in working capital | $-14,059$ | $-14,494$ | $-124,708$ | 9,289 | 85,949 |
| Cash flow from operating activities | $-30,008$ | $-23,972$ | $-200,128$ | $-45,195$ | $-5,657$ |
| Investing activities | |||||
| Acquisition of intangible assets | $\mathbf 0$ | $\theta$ | 0 | $-355$ | $-355$ |
| Acquisition of tangible assets | $-1,616$ | $-363$ | $-1,855$ | $-473$ | $-984$ |
| Divestment/amortization of other financial assets | $\mathbf{0}$ | 406 | 0 | 406 | 406 |
| Increase/decrease in current financial investments | 0 | $\mathbf{0}$ | 0 | 157,908 | 157,908 |
| Cash flow from investing activities | $-1,616$ | 43 | $-1,855$ | 157,486 | 156,975 |
| Financing activities | |||||
| Increase/decrease in current financial liabilities | 0 | $\circ$ | $\mathbf 0$ | $\circ$ | $\Omega$ |
| New share issue | $\theta$ | 0 | $\Omega$ | $\Omega$ | 564,722 |
| Warrants issued | 889 | 0 | 4,135 | $\circ$ | $\Omega$ |
| Cash flow from financing activities | 889 | $\Omega$ | 4,135 | $\Omega$ | 564,722 |
| Net cash flow for the period | $-30,735$ | $-23,929$ | $-197,848$ | 112,291 | 716,040 |
| Cash and cash equivalents at beginning of period | 548,983 | 136,276 | 716,096 | 56 | 56 |
| Exchange rate differences in cash equivalents | 0 | 0 | 0 | $\Omega$ | $\Omega$ |
| Cash and cash equivalents at the end of period | 518,248 | 112,347 | 518,248 | 112,347 | 716,096 |
| KSEK | Note | 2016 Jul-Sep |
2015 Jul-Sep |
2016 Jan - Sep |
2015 Jan – Sep |
2015 Jan - Dec |
|---|---|---|---|---|---|---|
| Net sales | 30,531 | 37,232 | 76,611 | 118,459 | 154,799 | |
| Cost of goods sold | $-546$ | $-131$ | $-911$ | $-132$ | $-237$ | |
| Gross profit | 29,985 | 37,101 | 75,699 | 118,327 | 154,562 | |
| Marketing and distribution costs | $-5,762$ | $-5,255$ | $-15,353$ | $-12,425$ | $-19,411$ | |
| Administrative expenses | $-4,392$ | $-925$ | $-13,919$ | $-18,712$ | $-11,934$ | |
| Research and development costs | $-36,182$ | $-37,741$ | $-111,497$ | $-110,731$ | $-151,354$ | |
| Other operating income | 294 | 267 | 43 | 41 | 57 | |
| Other operating expenses | $\Omega$ | $\Omega$ | $-728$ | $-904$ | $-658$ | |
| Operating result before items affecting comparability | 7 | $-16,057$ | $-6,553$ | $-65,754$ | $-24,404$ | $-28,738$ |
| Items affecting comparability attributable to public listing costs | 7 | $\circ$ | $\Omega$ | 0 | $\bigcap$ | $-33,970$ |
| Items affecting comparability attributable to Share bonus program | 7 | $\Omega$ | $-22,075$ | 0 | $-138,075$ | $-139,671$ |
| Operating result | $-16,057$ | $-28,628$ | $-65,754$ | $-162,479$ | $-202,379$ | |
| Result from interests in Group companies | $\theta$ | $\theta$ | $\Omega$ | $\Omega$ | 0 | |
| Interest income and similar items | 8 | |||||
| Interest expense and similar items | $-366$ | -4 | $-874$ | $-21$ | $-166$ | |
| Result after financial items | $-16,422$ | $-28,631$ | $-66,620$ | $-162,499$ | $-202,543$ | |
| Appropriations | $\circ$ | $\overline{0}$ | 0 | $\circ$ | 15,096 | |
| Result before tax | $-16,422$ | $-28,631$ | $-66,620$ | $-162,499$ | $-187,447$ | |
| Tax on profit for the period | 9 | 3,613 | 6,299 | 14,656 | 35,750 | 41,026 |
| Result for the period | $-12,809$ | $-22,332$ | $-51,964$ | $-126,749$ | $-146,421$ |
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 | 30-09-2016 | 30-09-2015 | 31-12-2015 |
|---|---|---|---|---|
| ASSETS | ||||
| Fixed assets | ||||
| Tangible fixed assets | ||||
| Equipment | 7,371 | 6,566 | 6,634 | |
| Financial fixed assets | ||||
| Interest in Group companies | 573 | 573 | 573 | |
| Deferred tax assets | 9 | 59,047 | 35,988 | 44,391 |
| Total fixed assets | 66,991 | 43,127 | 51,598 | |
| Current assets | ||||
| Inventories | ||||
| Finished goods and goods for resale | 3,957 | 2,570 | 3,242 | |
| Current receivables | ||||
| Receivables from parent company | $\Omega$ | $\Omega$ | 207 | |
| Trade receivables | 17,408 | 27,792 | 8,917 | |
| Other receivables | 3,669 | 2,150 | 5,500 | |
| Prepayments and accrued income | 24,742 | 9,516 | 15,613 | |
| Total current receivables | 45,820 | 39,458 | 30,237 | |
| Cash and bank deposits | 518,248 | 112,347 | 716,096 | |
| Total current assets | 568,024 | 154,375 | 749,575 | |
| TOTAL ASSETS | 635,015 | 197,502 | 801,173 |
| KSEK Note |
30-09-2016 | 30-09-2015 | 31-12-2015 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| Restricted equity | |||
| Restricted equity (37 281 486 shares) | 932 630 |
932 | |
| Statutory reserve | 11,327 | 11,327 | 11,327 |
| Total restricted equity | 12,259 | 11,957 | 12,259 |
| Unrestricted equity | |||
| Retained earnings | 17,746 | 162,673 | 164,167 |
| Share premium reserve | 596,699 | 25,017 | 592,565 |
| Result for the period | $-51,964$ | $-126,749$ | $-146,421$ |
| Total unrestricted equity | 562,482 | 60,941 | 610,311 |
| TOTAL EQUITY | 574,741 | 72,898 | 622,570 |
| LIABILITIES | |||
| Untaxed reserves | |||
| Depreciation/amortization in excess of plan | 2,239 | 1,825 | 2,239 |
| Tax allocation reserve | 15,510 0 |
0 | |
| Total untaxed reserves | 2,239 | 17,335 | 2,239 |
| Long-term liabilities | |||
| Liability to subsidiaries | 573 573 |
573 | |
| Total long-term liabilities | 573 573 |
573 | |
| Short-term liabilities | |||
| Liabilities to Group companies | $\overline{2}$ 0 |
0 | |
| Trade payables | 7,832 | 14,177 | 31,832 |
| Current tax liability | 8,936 0 |
9,917 | |
| Other liabilities | 1,933 | 1,292 | 88,088 |
| Accrued expenses and deferred income | 47,698 | 82,290 | 45,954 |
| Total short-term liabilities | 57,462 | 106,697 | 175,791 |
| TOTAL EQUITY AND LIABILITIES | 635,015 | 197,502 | 801173 |
CAMURUS INTERIM REPORT THIRD QUARTER 2016 $\:$ $\,$ $\,$ $\,$ $\,$ $\,$ $\,$ $\,$ $\,$
| MSEK | 2016 Jul-Sep |
2015 Jul-Sep |
2016 Jan - Sep |
2015 Jan – Sep |
2015 Jan - Dec |
DEFINIT |
|---|---|---|---|---|---|---|
| Net revenue | 30.5 | 37.2 | 76.6 | 118.5 | 154.8 | Equity ratio, |
| Operating result before items affecting comparability |
$-16.6$ | $-7.1$ | $-67.3$ | $-25.6$ | $-30.5$ | Average nur before dilut |
| Operating result | $-16.6$ | $-29.1$ | $-67.3$ | $-163.7$ | $-204.1$ | |
| Result for the period | $-13.2$ | $-22.7$ | $-53.2$ | $-127.7$ | $-159.5$ | Average nur |
| Cash flow from operating activities | $-30.0$ | $-24.0$ | $-200.1$ | $-45.2$ | $-5.7$ | after dilutior |
| Cash and cash equivalents | 518.2 | 112.3 | 518.2 | 112.3 | 716.1 | Earnings pe |
| Equity | 591.5 | 103.1 | 591.5 | 103.1 | 640.6 | dilution, SEK |
| Equity ratio in Group, percent | 91% | 49% | 91% | 49% | 78% | Earnings pe |
| Total assets | 649.0 | 209.8 | 649.0 | 209.8 | 816.3 | dilution, SEK |
| Weighted average number of shares, before dilution |
37,281,486 | 25,208,560 | 37,281,486 | 25,208,560 | 26,497,361 | Equity per s |
| Weighted average number of shares, after dilution*) |
37,618,063 | 25,677,878 | 37,432,224 | 25,364,999 | 37,281,486 | dilution |
| Earnings per share before dilution, SEK | $-0.35$ | $-0.90$ | $-1.43$ | $-5.07$ | $-6.02$ | Equity per s |
| Earnings per share after dilution, SEK*) | $-0.35$ | $-0.90$ | $-1.43$ | $-5.07$ | $-6.02$ | |
| Equity per share before dilution, SEK | 15.87 | 4.09 | 15.87 | 4.09 | 25.41 | R&D cost as |
| Equity per share after dilution, SEK*) | 15.70 | 4.01 | 15.70 | 4.01 | 17.18 | operating e: |
| Number of employees at end of period | 58 | 48 | 58 | 48 | 48 | |
| Number of employees in R&D at end of period | 42 | 35 | 42 | 35 | 35 | |
| R&D costs as a percentage of operating expenses |
78% | 86% | 79% | 78% | 83% |
| Weighted average number of shares before adjustment for dilution effect of net shares Weighted average number of shares adjustment for the dilution effect of new shares Result divided by the weighted average number of shares outstanding before dilution |
|---|
| Result divided by the weighted average number of shares outstanding after dilution |
| Equity divided by the weighted number of shares at the period before dilution |
| Equity divided by the weighted number of shares at the end of the period after dilution |
| Research and development costs divided by operating expenses, excluding items affecting comparability (marketing and distribution costs, administrative expenses and research and development costs). |
*) The dilution effect is calculated according to IAS 33.
Camurus AB, Corp. ID no. 556667-9105 is the parent company of the Camurus Group. Up until 7 October 2015, Camurus AB's registered offices were in Malmö, Sweden. The company is now based in Lund. Sweden, at Ideon Science Park, 223 70 Lund.
Camurus AB Group's interim report for the third quarter 2016 was approved for publication in accordance with a decision from the Board on 7 November 2016.
All amounts are stated in SEK thousand (KSEK), unless otherwise indicated. Figures in brackets refer to the year-earlier period.
The consolidated financial statements for the Camurus AB Group ('Camurus') have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU, as well as the Swedish Financial Reporting Board's Recommendation RFR 1 Supplementary Accounting Rules for Groups, and the Swedish Annual Accounts Act.
This interim report has been drawn up in accordance with IAS 34, Interim Financial Reporting, the Swedish Annual Accounts Act and RFR 1 Supplementary Accounting Rules for Groups.
The parent company statements have been prepared in accordance with the Annual Accounts Act and recommendation RFR 2 Accounting for legal entities from the Swedish Financial Reporting Board. The application of RFR 2 means that the parent company in the interim report for the legal entity shall apply all EU-approved IFRS standards and statements as far as possible within the framework of the Annual Accounts Act, the Pension
Obligations Vesting Act (Tryggandelagen) and taking into consideration the relationship between accounting and taxation. The parent company's accounting policies are the same as for the Group, unless otherwise stated in Note 2.2.
The most important accounting policies that are applied in the preparation of these consolidated financial statements are detailed below
2.1.1 Changes to accounting policies and disclosures New or revised IFRS standards that have come into force have not had any material impact on the Group.
The parent company applies accounting policies that differ from those of the Group in the cases stated below.
All expenses that relate to the development of internally generated intangible assets are recognized as expenses as they arise.
Interests in subsidiaries are reported at cost, less any impairment losses. The cost includes acquisition-related expenses and any additional considerations.
When there is an indication that interests in subsidiaries have decreased in value, a calculation is made of the recoverable amount. If this amount is lower than the reported amount, an impairment is carried out. Impairment losses are recognized under the item "Result from interests in Group companies".
Group contributions paid by the parent company to subsidiaries and Group contributions received from subsidiaries by the parent company are recognized as appropriations.
IAS 39 is not applied in the parent company and financial instruments are measured at cost
Until 3 December 2015, the group had a share-based compensation plan where the regulation should be made in shares and where the company received services from employees as consideration for the Group's own equity instruments (shares). The fair value of the service, which eligible employees to the allocation of shares, was expensed and the total amount to be expensed was based on the fair value of the shares granted.
At each reporting period Camurus assessed its estimates of the number of shares expected to vest based on the non-market vesting conditions and service conditions. Any deviation from the original estimates as the review gave rise to, were recognized in the income statement and corresponding adjustments made to equity
When bonus shares were exercised, the Company issued new shares. The proceeds received net of any directly attributable transaction costs are credited to share capital (quota value) and other capital contributions. The social security contributions which arose on the allocation of the shares was regarded as an integral part of the award, and the cost was treated as a cash-settled share-based payment.
Company management have established that the Group as a whole constitutes one segment based on the information managed by the CEO, in consultation with the Board, and which is used as a basis for allocating resources and evaluating results.
To follow is a breakdown of revenues from all products and services.
| KSEK | 2016 Jul - Sep |
2015 Jul - Sep |
2016 Jan - Sep |
2015 Jan - Sep |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Sales of development related goods and services | 11,913 | 15,825 | 46.746 | 67,986 | 93,845 |
| Milestone payments | 17,220 | 21.050 | 19.518 | 42.700 | 52,850 |
| Licensing revenues | 80 | 180 | 8,425 | 7.193 | 7,238 |
| Other | 1.318 | 177 | 1.922 | 580 | 866 |
| Total | 30,531 | 37,232 | 76,611 | 118,459 | 154,799 |
Revenues from external customers is allocated by country, based on where the customers are located.
| KSEK | 2016 Jul - Sep |
2015 Jul - Sep |
2016 Jan - Sep |
2015 Jan - Sep |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Europe | 5,697 | 26.544 | 20.792 | 95.761 | 108,067 |
| (of which Sweden) | (770) | (196) | (3,661) | (1,906) | (2,275) |
| North America | 24,491 | 10.666 | 52,998 | 15.639 | 39,635 |
| Other geographical areas | 343 | 21 | 2,821 | 7,058 | 7,097 |
| Totalt | 30,351 | 37,232 | 76,611 | 118,459 | 154,799 |
Revenue during the quarter of approximately MSEK 26.6 (26.5) relates to one single external customer. All fixed assets are located in Sweden.
Earnings per share before dilution is calculated by dividing the result attributable to shareholders of the parent company by a weighted average number of ordinary shares outstanding during the period. During the period, no shares held as treasury shares by the parent company have been repurchased.
| KSEK | 2016 Jul - Sep |
2015 Jul - Sep |
2016 Jan - Sep |
2015 Jan - Sep |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders | $-13.215$ | $-22.739$ | $-53.182$ | $-127.692$ | $-159.542$ |
| Total | $-13.215$ | $-22.739$ | $-53.182$ | -127.692 | $-159.542$ |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 25,209 | 37,281 | 25,209 | 26,497 |
In order to calculate earnings per share, the number of existing ordinary shares is adjusted for the dilutive effect of the weighted average number of outstanding ordinary shares. The parent company has one category of ordinary shares with anticipated dilution effect in the form of warrants. For warrants, a calculation is made of the number of shares that could have been purchased at fair value (calculated as the average market price for the year for the parent company's shares), at an amount corresponding to the monetary value of the subscription rights linked to outstanding warrants. The number of shares calculated as above is compared to the number of shares that would have been issued assuming the warrants are exercised.
| KSEK | 2016 Jul – Sep |
2015 Jul – Sep |
2016 Jan - Sep |
2015 Jan - Sep |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders | $-13.215$ | $-22.739$ | $-53.182$ | -127.692 | $-159,542$ |
| Total | $-13,215$ | $-22,739$ | $-53,182$ | $-127.692$ | $-159,542$ |
| Weighted average number of ordinary shares outstanding (thousands) |
37,281 | 25,209 | 37,281 | 25,209 | 26,497 |
| Adjustments: | |||||
| warrants (thousands) $\sim$ |
337 | ٠ | 151 | 1,047 | |
| share issues (thousands) $\sim$ |
$\overline{\phantom{a}}$ | 469 | $\qquad \qquad -$ | 156 | 9,737 |
| Weighted average number of ordinary shares in calculation of earnings per share after dilution (thousands) |
37,618 | 25,678 | 37,432 | 25,365 | 37,281 |
All of the Group's financial instruments that are measured at amortized cost are short-term and expire within one year. The fair value of these instruments is deemed to correspond to their reported amounts, since discounting effects are minimal.
| Carrying amount, KSEK | 30-09-2016 | 30-09-2015 31-12-2015 | |
|---|---|---|---|
| Loans and receivables | |||
| Trade receivables | 17,408 | 27,792 | 8,917 |
| Receivables from Group companies | 207 | ||
| Other receivables | |||
| Cash and cash equivalents | 518,248 | 112,347 | 716,096 |
| Total | 535,656 | 140,139 | 725,220 |
| Other liabilities | |||
| Other financial liabilities | |||
| Liabilities to Group companies | |||
| Trade payables | 7,832 | 14,177 | 31,641 |
| Other current liabilities | 191 | 191 | 191 |
| Total | 8,023 | 14,368 | 31,832 |
Investor relations services have been acquired from Piir & Partners AB, whose representative is a member of the management team. Pricing is done in accordance with allocation of costs in relation to utilization rate and on market terms.
At the end of the period the company had a debt to Piir & Partner AB regarding these services that amounted to MSEK 0.3 (0.1). There were no other receivables or liabilities.
Up and until third quarter this year, no items affecting comparability have arisen.
The costs charged to the previous year's results relate to listing expenses, in connection with preparations of the public listing of the company's shares on Nasdaq, Stockholm, and to the share bonus program, implemented in 2013 and fulfilled December 3, 2015 when Camurus' shares were listed on the stock exchange.
Following below is the consolidated income statement as it would have looked had the listing expenses and the cost for the share bonus program not been separated out.
| 2016 | 2015 | 2016 | 2015 | 2015 | ||
|---|---|---|---|---|---|---|
| KSEK | Note | Jul - Sep | Jul - Sep | Jan – Sep | Jan – Sep | Jan - Dec |
| Revenues | 3 | 30,531 | 37,232 | 76,611 | 118,459 | 154,799 |
| Cost of goods sold | $-546$ | $-131$ | $-911$ | $-132$ | $-237$ | |
| Gross profit | 29,985 | 37,101 | 75,699 | 118,327 | 154,562 | |
| Marketing and distribution costs | $-5,762$ | $-4,701$ | $-15,353$ | $-23,471$ | $-31,338$ | |
| Administrative expenses | $-4,392$ | 7,862 | $-13,919$ | $-43,565$ | $-74,790$ | |
| Research and development costs | $-36,702$ | $-69,679$ | $-113,059$ | $-214,116$ | $-251,937$ | |
| Other operating income | 294 | 267 | 43 | 41 | 57 | |
| Other operating expenses | 0 | 0 | $-728$ | $-904$ | $-658$ | |
| Operating result | 6 | $-16,577$ | $-29,149$ | $-67,316$ | -163,688 | $-204,104$ |
| Finance income | 8 | 2 | ||||
| Finance expenses | $-366$ | $-4$ | $-874$ | $-21$ | $-166$ | |
| Net financial items | $-365$ | -3 | $-866$ | $-20$ | $-164$ | |
| Result before tax | $-16,942$ | $-29,152$ | $-68,182$ | $-163,708$ | $-204,268$ | |
| Income tax | 9 | 3,727 | 6,414 | 15,000 | 36,016 | 44,727 |
| Result for the period | $-13,215$ | $-22,739$ | $-53,182$ | -127,692 | -159,542 |
Adjustment for non-cash items:
| KSEK | 2016 Jul - Sep |
2015 Jul - Sep |
2016 Jan – Sep |
2015 Jan – Sep |
2015 Jan - Dec |
|---|---|---|---|---|---|
| Depreciation | 993 | 886 | 2,679 | 2,588 | 3,552 |
| Costs of share bonus program | $\Omega$ | 19.000 | 107.300 | 108,793 | |
| Total | 993 | 19,886 | 2,679 | 109,888 | 112,345 |
Tax for the quarter amounted to MSEK 3.7 (6.4), primarily attributable to the negative result.
The change in equity for the quarter is mainly attributable to the loss.
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 07.00 AM CET on 8 November 2016.
CAMURUS AB Ideon Science Park, SE-223 70 Lund, Sweden
Phone: +46 286 57 30 Fax: +46 286 57 39 E-mail: [email protected]
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