Quarterly Report • May 7, 2020
Quarterly Report
Open in ViewerOpens in native device viewer

INTERIM REPORT FOR THE FIRST QUARTER 2020
Camurus is an international science-led biopharmaceutical company committed to developing and commercializing innovative medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the Company's proprietary FluidCrystal® drug delivery technologies and its extensive R&D and sales expertise. Camurus' clinical pipeline includes product candidates for the treatment of cancer, endocrine diseases, pain and addiction, which are developed in-house and in collaboration with international pharmaceutical companies. Camurus' shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit camurus.com
• Camurus announces strong first quarter demand for Buvidal and reiterates the financial outlook for 2020 with expected revenues in the higher interval

| MSEK | 2020 Jan-Mar |
2019 Jan-Mar |
% ∆ | 2019 Jan-Dec |
to Brixadi™ in the US |
|---|---|---|---|---|---|
| Total revenues whereof product sales OPEX |
49.3 48.6 117.3 |
18.5 11.0 99.4 |
167% 343% 18% |
105.6 72.1 443.2 |
|
| Operating result Result for the period Result per share, before and after dilution, of SEK Cash position |
-76.9 -61.6 -1.19 291.3 |
-84.4 -67.6 -1.62 406.6 |
9% 9% 27% -28% |
-360.0 -289.9 -6.23 358.7 |

Product sales SEK 48.6 million +343%
OPEX SEK 117.3 million +18%
Expected net revenues* SEK 290 - 330 M whereof product sales of SEK 240 - 280 M Expected full year OPEX SEK 570 - 610 M
*excl milestone payments relating
Financial analysts, investors and media are invited to attend a telephone conference and presentation of the first quarter results today at 2 pm (CET).
The conference call can also be followed by a link on camurus.com or via external link: https://financialhearings.com/event/12772
Camurus started 2020 with strong growth in revenue driven by increasing demand for weekly and monthly Buvidal. We saw a 90 percent increase in the number of patients receiving treatment in the quarter. Buvidal is now the market leader in both Finland and Norway, with the strongest growth occurring in Australia. This positive trend in all markets was partly catalyzed by the ongoing Covid-19 pandemic, as treatment providers recognized the benefits Buvidal offers in terms of reducing the treatment burden for both patients and healthcare professionals in a hard-pressed healthcare sector. During this quarter, we continued to improve the availability of Buvidal in our markets. The Australian regulatory agency extended access, allowing GPs – who treat the majority of patients with opioid dependence – to prescribe Buvidal. In Germany and Austria, renumeration and legislative changes were put forward to facilitate access to long-acting medications.

Camurus started 2020 with a 60% increase in product sales compared to previous quarters – and a 340% increase compared to the first quarter of 2019. Sales of Buvidal in the first quarter of 2020 were SEK 48.6 million with total revenue of SEK 49.3 million. Less than a year after launch, sales are on a positive upward trend in all launch markets in Europe, and Buvidal is the market leader in both Finland and Norway. Australia is currently the fastest growing market with approximately 3,000 patients in treatment with Buvidal 6 months after its launch. This success has been driven by our skilled commercial and medical teams, together with the positive results and experiences from research collaborations and
clinical studies conducted in partnership with clinical experts and authorities in Australia. In total, more than 7,500 patients were treated with Buvidal at the end of the quarter – which is nearly a 90% increase over the fourth quarter of 2019. Our flexible manufacturing operation has adapted quickly to the increasing demand for Buvidal ensuring appropriate licenses and deliveries are in place without any major disruption to supply in our markets. In the beginning of April, we announced high demand for Buvidal and that we expect revenues to reach the higher end of guidance.
During the quarter, we continued to work to improve access to Buvidal. In Australia, the results from a 6-month trial period of Buvidal in commercial use was reported by
the pharmaceutical authority, the Therapeutic Goods Administration (TGA), and the authority extended prescribing from opioid dependence specialists to also include general practitioners, who treat the majority of Australia's patients with opioid dependence. In Germany, as of 1 April 2020, the remuneration system for physicians has been modified to improve access to new treatment options, including long-acting injectables. In Austria, a change in legislation is ongoing that will allow Buvidal to be available to patients in Q2 2020. With approximately 18,000 people in treatment for opioid dependence, Austria has as many patients in treatment as in all the Scandinavian countries together. In the UK, the Health Minister in Wales expressed support for the treatment of opioid dependent patients with long-acting buprenorphine during the ongoing Covid-19 crisis. In Norway, clinics have established outreach services to allow access to Buvidal for patients faced with the risk of coronavirus infection if attending the clinics on public transport. In this context, long-term injections offer benefits for both patients and healthcare professionals. Finally, in different parts of Europe and Australia, important initiatives have been taken to improve access to treatment for vulnerable patient groups, including the homeless and patients in the criminal justice system.
During the first quarter, a market authorization application for Buvidal was submitted to the Swiss Agency for Therapeutic Products (Swissmedic).
The DEBUT and UNLOC-T study reports were completed during the quarter. DEBUT is the first randomized open label
trial comparing patient-reported outcomes for a long-acting buprenorphine injection with daily sublingual buprenorphine standard of care. As previously announced, the study demonstrated statistically improved treatment effect, meeting the primary and several secondary patient reported endpoints, which further strengthen the scientific evidence base for Buvidal to become the future standard of care for patients with opioid dependence. The UNLOC-T study evaluated treatment with Buvidal compared to methadone in seven prisons in New South Wales, Australia. During the quarter, the results from both studies have been accepted for presentation at the leading addiction meeting, the College on Problems of Drug Dependence (CPDD), to be held virtually in June 2020.
An investigator initiated, prospective, observational study (ARIDE) began during the quarter. ARIDE will evaluate treatment with Buvidal compared to daily buprenorphine or methadone standard of care. The study will be coordinated by scientists at the Center of Interdisciplinary Addiction Research at Hamburg University, Germany. The study is expected to run for 2 years and recruit 426 outpatients, with results adding to the already extensive scientific evidence base for Buvidal.
Preparations for the registration of weekly and monthly CAM2038 for the treatment of chronic pain in Europe continued.
In the US, we look forward to a final market approval of Brixadi™ (the US trade name for Buvidal) 1 December 2020. The need for new effective treatments is immense in the US, with nearly 50,000 annual deaths caused by opioid overdose – the major
"Treatment providers recognized the benefits Buvidal offers in terms of reducing the treatment burden for both patients and healthcare professionals"
cause of death in people under 50 years old.1 With more than two million people diagnosed with opioid dependence, the US represents the largest single market for opioid dependence in the world.2 Our partner Braeburn is preparing for the launch of Brixadi shortly after market approval. In the Middle East the first patients started treatment during the quarter, and we are now working with our partner NewBridge Pharmaceuticals to increase availability of Buvidal in the region.
CAM2029 is a long-acting subcutaneous octreotide injection designed for easy self-administration, for the treatment of acromegaly and neuroendocrine tumors. During the quarter the ongoing Phase 3 studies in patients with acromegaly continued. However, due to Covid-19, the recruitment of new patients has temporarily stalled, which most likely will result in a delayed completion of enrollment in the ongoing studies. In mitigation, we have shifted our focus to other time critical activities – primarily the development of the CAM2029 autoinjector. Overall, we assess that Covid-19 will affect the acromegaly program timelines, but that this will be limited and clinical costs for the acromegaly program will shift forward.
During the period, we completed market assessments for potential additional indications of CAM2029. The results of these assessments are very positive and point to considerable medical needs and a significant sales potential for CAM2029 outside the prioritized areas in acromegaly and neuroendocrine tumors. Preparations for the start of pivotal studies of CAM2029 in one of these new indications, as well as in neuroendocrine tumors, are ongoing.
During the first quarter, our clinical trial application was granted for a Phase 2a study of our treprostinil weekly depot, CAM2043, in patients with Raynaud's phenomenon; a rare and serious condition characterized by episodes of pallor followed by cyanosis of fingers or toes, which can be very painful and cause digital ulcers and dry necrosis. The study was expected to start during the second quarter of 2020 but, due to Covid-19, study initiation has been moved to the second half of 2020.
In collaboration with Rhythm Pharmaceuticals, a Phase 2 study of weekly setmelanotide, CAM4072, for the treatment of genetic obesity disorders, is under completion. The study, which has recruited more than 70 participants with obesity, is designed to evaluate the pharmacokinetics, pharmacodynamics and safety of CAM4072 after 3 months of treatment. Results are expected later in 2020. Manufacturing preparations for the start of the pivotal study program are ongoing.
During the quarter, preparations continued for the start of the clinical development of long-acting zilucoplan, CAM4083, developed in collaboration with our partner Ra Pharmaceuticals, for the treatment of complement C5 mediated diseases. In April 2020, the Belgian pharmaceutical company UCB completed the acquisition of Ra Pharmaceuticals.
In addition to collaborations with Rhythm and Ra Pharmaceuticals, we initiated two new research collaborations with international pharmaceutical companies. These collaborations will be communicated when we enter into relevant clinical development programs or with the announcement of license agreements.
"We initiated two new research collaborations with international pharmaceutical companies"
We assess that the increasing demand for Buvidal in the EU and Australia in the first quarter will continue during the second quarter, supported by regulatory, renumeration, and legal changes, and our expansion into new markets. Due to Covid-19, this trend is reinforced by the need to decrease non-essential clinic visits and optimize the use of resources in strained healthcare systems. Covid-19 has presented us with significant challenges to ensure product supply and medical support for healthcare providers and patients. It is very gratifying to see how well our commercial and medical teams, and our robust and streamlined manufacturing and supply chain, has handled the situation.
For people suffering from chronic conditions, for whom lifelong medication has become a reality, there is much to be gained from improving treatments – in terms of efficacy and quality of life, but also in terms of how the treatments are administered – and this coronavirus pandemic has further highlighted the benefits of such long-acting treatments.
Overall, Camurus stands strong at a challenging and uncertain time.
Fredrik Tiberg, President and Chief Executive Officer
"The increasing demand for Buvidal in the EU and Australia is expected to continue in the second quarter, supported by regulatory, remuneration, and legal changes, and our expansion to new markets."
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.
Buvidal® Opioid dependence
Brixadi™ Opioid dependence1) CAM2038 Chronic pain1) CAM2029 Acromegaly CAM2029 Neuroendocrine tumors CAM2032 Prostate cancer CAM4072 Genetic obesity disorders2) CAM2043 Pulmonary arterial hypertension CAM2043 Raynaud's phenomenon CAM4071 Endocrine disorders CAM2047 CINV3) CAM2048 Postoperative Pain1)
episil® Oral liquid

Opioid dependence is a serious, chronic, relapsing disease and a growing global health problem. Pharmacological treatment with daily buprenorphine and methadone is the current medical standard of care, effectively reducing withdrawal and cravings, and the risk of overdoses. However, these treatments are also associated with limitations such as poor treatment adherence, misuse, medication diversion, and accidental pediatric exposure.
Buvidal®, long-acting subcutaneous buprenorphine, provides the opportunity for patients and healthcare professionals to focus on recovery instead of spending time and resources on supervised medication. With the availability of both weekly and monthly formulations as well as multiple dose options, treatment can be tailored to each patient's specific needs and circumstances. Buvidal gives both a fast onset and a long-acting effect and effectively reduces withdrawal symptoms and cravings for opioids. Should the patient temporarily relapse and take heroin or other opioids, Buvidal blocks the opioid effect and could protect against overdose.
Buvidal has been studied in an extensive clinical development program consiting of seven studies, including two Phase 3 studies. In addition to demonstrating non-inferior and superior treatment effect in reducing patients' use of illicit opioids compared to daily sublingual buprenorphine, studies have shown a high satisfaction, treatment retention and a good safety profile. Patients can begin medical treatment of opioid dependence with Buvidal from day 1, or switch from their current daily standard therapy with sublingual buprenorphine directly onto Buvidal, according to a dose conversion table. It is also possible for patients previously treated with methadone to switch to Buvidal. Buvidal is available for patients in Finland, Sweden, Denmark, Norway, Germany, the UK and Australia since 2019.
The clinical study reports for the clinical studies DEBUT and UNLOC-T, which have compared Buvidal with standard of care treatment in community and prison settings in Australia, were finished during the quarter. DEBUT showed superior patient reported treatment satisfaction as well as statistically reduced treatment burden and improved quality of life with Buvidal versus buprenorphine standard of care. UNLOC-T also met both primary and secondary endpoints. Results from both studies have been accepted for presentation at the College on Problems of Drug Dependence conference in June. In Germany a new investigator sponsored observational study called ARIDE comparing Buvidal with treatment with daily buprenorphine or methadone with regards to quality of life and other patient reported outcomes. Alongside the progress of clinical studies, an application for market approval was sent to the Swiss agency for therapeutic products.

CAM2038 is being developed to provide round-the-clock pain relief, while decreasing the risk of respiratory depression and fatal overdoses associated with full mu-opioid agonists, and at the same time protect against misuse, abuse and illicit diversion. CAM2038 is primarily addressing needs for patients on high doses – there are currently more than 1 million patients in the US, Europe and Japan on daily opioid doses of 99 mg morphine equivalents or more. CAM2038 has been evaluated in a Phase 3 pivotal Phase 3 study in opioid experienced patients with chronic low-back pain. The study met both the primary and secondary endpoints. In addition, CAM2038 was studied in a Phase 3 extension study in patients with chronic, non-cancer pain.
During the quarter a scientific advisory board was held in the US. In the EU, preparations for a marketing authorization application progressed, towards a planned submission in the third quarter of 2020.
CAM2029 is a ready-to-use long-acting subcutaneous depot of the active substance octreotide, used for the treatment of acromegaly and neuroendocrine tumors. Somatostatin analogues, including octreotide, today represent pharmacological standard of care with annual sales of more than 2.8 billion USD in 2019.
CAM2029 is designed for easy self-administration by patients themselves using a prefilled syringe or an autoinjector offering the potential for improved patient convenience. In addition, CAM2029 provides higher bioavailability of octreotide in comparison to the current market leading product Sandostatin LAR, which may improve treatment efficacy for patients not responding satisfactory to current therapies.
In 2019, two Phase 3 studies of CAM2029 for the treatment of acromegaly were initiated.
Recruitment to the two phase 3 studies is ongoing. The studies were expected to be fully recruited during 2020 with results delivered in 2021, however delays are to be expected due to the Covid-19 pandemic.
CAM2043 is a long-acting subcutaneous treprostinil formulation developed as a patient-friendly and effective treatment option for pulmonary arterial hypertension (PAH) and Raynaud's phenomenon (RP). Annual sales of current treprostinil products amount to more than 1 billion USD, the majority being parenteral treprostinil. Besides providing less frequent administration, CAM2043 can reduce the risks associated with current parenteral products for PAH, such as infusion related reactions, or the need to continuously carry an infusion pump. CAM2043 has been investigated in a completed open-label Phase 1 trial.
Preparations for Phase 2 studies of CAM2043 for the treatment of PAH and RP are ongoing. A clinical trial application for Phase 2 study in Raynaud's phenomenon has been granted by MHRA in UK. The study is expected to be initiated in H2 2020.
CAM4072 is a weekly formulation of the MC4 agonist setmelanotide developed together with our partner Rhythm Pharmaceuticals for the treatment of rare genetic obesity disorders. The product candidate is currently being studied in a Phase 2a study in participants with obesity, which is expected to be completed in 2020.
CAM4083 is a long-acting formulation of the complement component C5 inhibitor zilucoplan, which is being developed together with our partner Ra Pharmaceuticals for the treatment of generalized myasthenia gravis and other serious tissue-based complement-mediated disorders.
CAM4071 is a long-acting formulation of pasireotide. Pasireotide is currently approved for the treatment of Cushing's syndrome and acromegaly as a secondline treatment. CAM4071 has completed a dose escalating Phase 1 study of pharmacokinetics, pharmacodynamics and safety in healthy volunteers.
CAM2032 is a long-acting subcutaneous leuprolide depot for the treatment of prostate cancer. It is developed for convenient self-administration by patients and has been successfully evaluated in two Phase 2 studies in prostate cancer. Additional potential indications for CAM2032 include endometriosis and precocious puberty. Discussions with potential development and commercialization partners are ongoing.
CAM2047 is a long-acting subcutaneous granisetron depot in development for the treatment of acute and delayed chemotherapy-induced nausea and vomiting, a side effect experienced by the majority of cancer patients undergoing chemotherapy treatment. CAM2047 has been successfully evaluated in a completed Phase 1 trial. Partnering discussions are ongoing.
CAM2048 is a buprenorphine depot formulation for the treatment of postoperative pain providing rapid onset of action and therapeutic buprenorphine plasma levels over a couple of days. CAM2048 is being developed in collaboration with Braeburn Pharmaceuticals and has been successfully evaluated in a completed Phase 1 trial. Partnering discussions are ongoing.
episil® oral liquid is a medical device for the treatment of inflammatory and painful conditions in the oral cavity. The product provides fast pain relief and protection of sore and inflamed mucosal surfaces caused, for example, by oral mucositis, a common and serious side effect of cancer treatment. When in contact with the buccal membrane, episil transforms into a thin protective layer of gel, offering effective pain relief for up to 8 hours. episil oral liquid is based on Camurus' FluidCrystal® topical bioadhesive technology.
Sales and distribution of episil are conducted via in-house marketing in Sweden, Finland, Denmark, Norway, and the UK, and through distribution partners in other countries like Japan, China and Australia.

The revenues during the quarter amounted to MSEK 49.3 (18.5), an increase by 167 percent. Product sales were MSEK 48.6 (11.0), corresponding to an increase of 343 percent compared to Q1 2019 and an increase by 60 percent compared to the previous quarter.
For further information, see Note 4.
Marketing and distribution costs amounted to MSEK 42.2 (37.8), an increase linked to ongoing launches of Buvidal in Europe and Australia as well as expansion to new markets.
Administrative expenses for the quarter were MSEK 6.5 (6.9).
R&D costs, including depreciation and amortization of tangible and intangible assets were MSEK 68.7 (54.6). The increase compared to previous year is primarily related to the ongoing pivotal Phase 3 program for CAM2029, for treatment of acromegaly.
The operating result for the quarter was MSEK -76.9 (-84.4).
Financial items in the period were MSEK -0.3 (-0.4).
Tax in the quarter was MSEK 15.7 (17.2), a tax income mainly representing deferred tax for the reported loss during the period.
The result for the period amounted to MSEK -61.6 (-67.6), an improvement attributable to the increased product sales. Earnings per share, before and after dilution, were SEK -1.19 (-1.62).
Cash flow from operating activities, before change in working capital, amounted to MSEK -75.2 (-82.7).
Cash flow from investing activities was MSEK -0.6 (-4.8) and relates to investments in ongoing clinical trials for Buvidal.
From financing activities cash flow was MSEK -1.1 (368.1). The difference compared to the same quarter last year mainly relates to proceeds from the rights issue in March 2019.
The Company's cash position as of 31 March, 2020 was MSEK 291.3 (406.6).
The Company had no loans as of 31 March, 2020 and no loans have been taken up since.
Consolidated equity as of 31 March, 2020 was MSEK 570.5 (561.2).
Revenues amounted to MSEK 52.6 (24.1) and the result after tax was MSEK -65.0 (-73.6).
On 31 March 2020, equity in the Parent company amounted to MSEK 520.3 (533.5) and total assets to MSEK 639.2 (646.1), of which MSEK 260.8 (394.4) were cash and cash equivalents.
No acquisitions or divestments have taken place during the period.
Camurus' share is listed on Nasdaq Stockholm.
At the end of the period, the total number of shares and votes was 51,636,858 (47,976,858) and the difference compared to last year relates to the directed share issue completed in December 2019.
Currently Camurus has three subscription warrant programs active for the Company's employees. During the quarter, earnings after tax were negatively impacted by MSEK 1.3 related to the stay-on bonus the participants receive as part of the programs. More information about the programs are found in Note 2.3.
On 2 April, Camurus announced strong Buvidal sales, and reiterated the financial outlook for 2020 with expected revenues at the higher end of previously communicated guidance.
At the end of the period, Camurus had 127 (103) employees, of whom 74 (62) were within research and development, 42 (32) within business development and marketing and sales, while 10 (8) were within administration. The number of employees, in terms of full-time equivalents, amounted to 115 (92) during the quarter.
Camurus is expecting revenues for the full year to be between MSEK 290 – 330, excluding milestone payments relating to Brixadi™ in the US. Product sales are expected to be between MSEK 240 – 280. Full year OPEX (operating expenses) is expected to be in the range of MSEK 570-610.
The outlook is based on exchange rates in December 2019.
Camurus Annual General Meeting will be held on Thursday 7 May, 2020, at 17.00 CET, at Elite hotel Ideon, Sceelevägen 27, Ideon Science Park, 223 63 Lund, Sweden.
The 2019 annual report was published on 8 April 2020 and is available at Camurus website www.camurus.com.
This report has not been reviewed by the Company's auditor.
This report includes forward-looking statements about expected and assumed future events, such as start of new development programs and regulatory approvals, and financial performance. These events are subject to risks, uncertainties and assumptions, which may cause actual results to differ materially from previous judgements.
| AGM 2020 | 7 May, 2020 at 5 pm CET |
|---|---|
| Q2 2020 | 16 July, 2020 |
| Q3 2020 | 5 November, 2020 |
For further information, please contact: Fredrik Tiberg, President and CEO Tel. +46 46 286 46 92, e-mail: [email protected]
Lund, Sweden, 7 May, 2020 Camurus AB Board of Directors
| KSEK Note |
2020 Jan-Mar |
2019 Jan-Mar |
2019 Jan-Dec |
|---|---|---|---|
| Net revenues 4 |
49,296 | 18,494 | 105,605 |
| Cost of goods sold | -7,780 | -2,997 | -23,287 |
| Gross profit | 41,516 | 15,497 | 82,318 |
| Operating expenses | |||
| Marketing and distribution costs | -42,175 | -37,779 | -170,540 |
| Administrative expenses | -6,463 | -6,934 | -23,468 |
| Research and development costs | -68,656 | -54,647 | -249,226 |
| Other operating income | 230 | 191 | 894 |
| Other operating expenses | -1,380 | -758 | – |
| Operating result | -76,928 | -84,430 | -360,022 |
| Finance income | 54 | 22 | 43 |
| Finance expenses | -392 | -406 | -1,585 |
| Net financial items | -338 | -384 | -1,542 |
| Result before tax | -77,266 | -84,814 | -361,564 |
| Income tax 9 |
15,714 | 17,188 | 71,699 |
| Result for the period1) 5 |
-61,552 | -67,626 | -289,865 |
| Other comprehensive income | |||
| Exchange-rate differences | 440 | 259 | 258 |
| Comprehensive income for the period | -61,112 | -67,367 | -289,607 |
1) All attributable to Parent Company shareholders.
| 2020 Jan-Mar |
2019 Jan-Mar |
2019 Jan-Dec |
|
|---|---|---|---|
| Earnings per share before dilution, SEK | -1.19 | -1.62 | -6.23 |
| Earnings per share after dilution, SEK | -1.19 | -1.62 | -6.23 |
For more information about calculation of earnings per share, see Note 5. Presently, the Company has three subscription warrant programs active. For further information see page 13 Camurus' share, and Note 2.3.
| KSEK | Note | 31-03-2020 | 31-03-2019 | 31-12-2019 |
|---|---|---|---|---|
| ASSETS | ||||
| Fixed assets | ||||
| Intangible assets | ||||
| Capitalized development expenditure | 37,221 | 19,975 | 37,335 | |
| Tangible assets | ||||
| Lease assets | 26,502 | 28,779 | 27,722 | |
| Equipment | 10,191 | 10,592 | 10,662 | |
| Financial assets | ||||
| Deferred tax receivables | 9 | 273,171 | 196,284 | 256,637 |
| Total fixed assets | 347,085 | 255,630 | 332,356 | |
| Current assets | ||||
| Inventories | ||||
| Finished goods and goods for resale | 16,819 | 10,078 | 14,243 | |
| Raw material | 20,234 | 6,109 | 18,849 | |
| Total inventories | 37,053 | 16,187 | 33,092 | |
| Current receivables | ||||
| Trade receivables | 41,597 | 5,452 | 34,791 | |
| Other receivables | 5,203 | 7,505 | 5,197 | |
| Prepayments and accrued income | 8,112 | 12,010 | 7,866 | |
| Total current receivables | 6 | 54,912 | 24,967 | 47,854 |
| Cash and cash equivalents | 291,301 | 406,622 | 358,744 | |
| Total current assets | 383,266 | 447,776 | 439,690 | |
| TOTAL ASSETS | 730,351 | 703,406 | 772,046 |
| KSEK Note |
31-03-2020 | 31-03-2019 | 31-12-2019 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| EQUITY | |||
| Equity attributable to | |||
| Parent Company shareholders | |||
| Share capital | 1,291 | 1,199 | 1,291 |
| Other contributed capital | 1,412,687 | 1,120,115 | 1,412,687 |
| Retained earnings, including | |||
| result for the period | -843,456 | -560,104 | -782,344 |
| Total equity 10 |
570,522 | 561,210 | 631,634 |
| LIABILITIES Long-term liabilities |
|||
| Lease liabilities | 21,837 | 24,456 | 22,938 |
| Total long-term liabilities | 21,837 | 24,456 | 22,938 |
| Short-term liabilities | |||
| Trade payables | 20,968 | 16,837 | 17,387 |
| Lease liabilities | 4,419 | 3,399 | 4,394 |
| Income taxes | 2,092 | 2,636 | 1,687 |
| Other liabilities | 14,899 | 11,368 | 5,806 |
| Accrued expenses and deferred income | 95,614 | 83,500 | 88,200 |
| Total short-term liabilities 6 |
137,992 | 117,740 | 117,474 |
| TOTAL EQUITY AND LIABILITIES | 730,351 | 703,406 | 772,046 |
| Share | Other contri buted |
Retained earnings, including result for |
Total | |||
|---|---|---|---|---|---|---|
| KSEK | Note | capital | capital | the period | equity | |
| Opening balance 1 January, 2019 | 960 | 744,101 | -492,737 | 252,324 | ||
| Comprehensive income for the period | – | -67,367 | -67,367 | |||
| Transactions with shareholders | ||||||
| Rights issue | 239 | 402,766 | – | 403,005 | ||
| Issuance costs, net after deferred tax | – | -26,752 | – | -26,752 | ||
| Closing balance 31 March, 2019 | 1,199 | 1,120,115 | -560,104 | 561,210 | ||
| Opening balance 1 January, 2019 | 960 | 744,101 | -492,737 | 252,324 | ||
| Comprehensive income for the period | – | – | -289,607 | -289,607 | ||
| Transactions with shareholders | ||||||
| Share issues1) | 331 | 702,794 | – | 703,125 | ||
| Issuance costs, net after deferred tax | – | -40,815 | – | -40,815 | ||
| Warrants issued | – | 6,607 | – | 6,607 | ||
| Closing balance 31 December, 2019 | 1,291 | 1,412,687 | -782,344 | 631,634 | ||
| Opening balance 1 January, 2020 | 1,291 | 1,412,687 | -782,344 | 631,634 | ||
| Comprehensive income for the period | – | – | -61,112 | -61,112 | ||
| Closing balance 31 March, 2020 | 10 | 1,291 | 1,412,687 | -843,456 | 570,522 |
1) Rights issue in March and directed share issue in December.
| KSEK Note |
2020 Jan-Mar |
2019 Jan-Mar |
2019 Jan-Dec |
|---|---|---|---|
| Operating activities | |||
| Operating profit/loss before financial items | -76,928 | -84,430 | -360,022 |
| Adjustments for non-cash items 8 |
2,469 | 2,156 | 9,014 |
| Interest received | 54 | 22 | 43 |
| Interest paid | -392 | -406 | -1,585 |
| Income taxes paid | -410 | 7 | -2,962 |
| -75,207 | -82,651 | -355,512 | |
| Increase/decrease in inventories | -3,961 | -6,357 | -23,262 |
| Increase/decrease in trade receivables | -6,806 | -3,172 | -32,511 |
| Increase/decrease in other current receivables | -252 | -211 | 6,241 |
| Increase/decrease in trade payables | 3,581 | -18,944 | -18,394 |
| Increase/decrease in other current operating liabilities | 16,912 | 20,885 | 19,074 |
| Cash flow from changes in working capital | 9,474 | -7,799 | -48,852 |
| Cash flow from operating activities | -65,733 | -90,450 | -404,364 |
| Investing activities | |||
| Acquisition of intangible assets | -411 | -4,525 | -23,442 |
| Acquisition of tangible assets | -228 | -318 | -2,462 |
| Cash flow from investing activities | -639 | -4,843 | -25,904 |
| Financing activities | |||
| Amortization of lease liabilities | -1,076 | -821 | -3,513 |
| Share issue after issuance costs | – | 368,970 | 651,197 |
| Warrants issued | – | – | 6,607 |
| Cash flow from financing activities | -1,076 | 368,149 | 654,291 |
| Net cash flow for the period | -67,448 | 272,856 | 224,023 |
| Cash and cash equivalents at beginning of the period | 358,744 | 134,377 | 134,377 |
| Translation difference in cash flow and liquid assets | 5 | -611 | 344 |
| Cash and cash equivalents at end of the period | 291,301 | 406,622 | 358,744 |
| KSEK Note |
2020 Jan-Mar |
2019 Jan-Mar |
2019 Jan-Dec |
|---|---|---|---|
| Net sales | 52,574 | 24,057 | 123,042 |
| Cost of goods sold | -10,794 | -2,997 | -22,965 |
| Gross profit | 41,780 | 21,060 | 100,077 |
| Operating expenses | |||
| Marketing and distribution costs | -47,477 | -53,768 | -201,261 |
| Administrative expenses | -6,409 | -1,445 | -23,560 |
| Research and development costs | -68,012 | -57,669 | -269,325 |
| Other operating income | 4 | 14 | 567 |
| Other operating expenses | -1,410 | -466 | – |
| Operating result | -81,524 | -92,274 | -393,502 |
| Interest income and similar items | 54 | 22 | 43 |
| Interest expense and similar items | -3 | -12 | -33 |
| Result after financial items | -81,473 | -92,264 | -393,492 |
| Result before tax | -81,473 | -92,264 | -393,492 |
| Tax on result for the period 9 |
16,478 | 18,622 | 78,983 |
| Result for the period | -64,995 | -73,642 | -314,509 |
Total comprehensive income is the same as result for the period, as the Parent Company contains no items that are recognized under other comprehensive income.
| KSEK Note |
31-03-2020 | 31-03-2019 | 31-12-2019 | |
|---|---|---|---|---|
| ASSETS | ||||
| Fixed assets | ||||
| Tangible assets | ||||
| Equipment | 10,024 | 10,387 | 10,479 | |
| Financial assets | ||||
| Interests in Group companies | 2,317 | 1,800 | 2,317 | |
| Deferred tax assets | 9 | 281,630 | 200,962 | 265,152 |
| Total fixed assets | 293,971 | 213,149 | 277,948 | |
| Current assets | ||||
| Inventories | ||||
| Finished goods and goods for resale | 12,354 | 10,078 | 13,579 | |
| Raw material | 20,234 | 6,109 | 18,849 | |
| Total inventories | 32,588 | 16,187 | 32,428 | |
| Current receivables | ||||
| Receivables subsidiaries | 10,806 | – | – | |
| Trade receivables | 30,129 | 5,452 | 31,777 | |
| Other receivables | 1,913 | 3,760 | 2,356 | |
| Prepayments and accrued income | 8,963 | 13,107 | 8,619 | |
| Total current receivables | 51,811 | 22,319 | 42,752 | |
| Cash and bank deposit | 260,789 | 394,446 | 332,607 | |
| Total current assets | 345,188 | 432,952 | 407,787 | |
| TOTAL ASSETS | 639,159 | 646,101 | 685,735 |
| KSEK Note |
31-03-2020 | 31-03-2019 | 31-12-2019 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| EQUITY | |||
| Restricted equity | |||
| Share capital (51,636,858 shares) | 1,291 | 1,199 | 1,291 |
| Statutory reserve | 11,327 | 11,327 | 11,327 |
| Total restricted equity | 12,618 | 12,526 | 12,618 |
| Unrestricted equity | |||
| Retained earnings | -806,432 | -491,923 | -491,923 |
| Share premium reserve | 1,379,073 | 1,086,501 | 1,379,073 |
| Result for the period | -64,995 | -73,642 | -314,509 |
| Total unrestricted equity | 507,646 | 520,936 | 572,641 |
| Total equity 10 |
520,264 | 533,462 | 585,259 |
| LIABILITIES | |||
| Untaxed reserves | |||
| Depreciation/amortization in excess of plan | 3,486 | 3,486 | 3,486 |
| Total untaxed reserves | 3,486 | 3,486 | 3,486 |
| Long-term liabilities | |||
| Liabilities to subsidiaries | 572 | 572 | 572 |
| Total long-term liabilities | 572 | 572 | 572 |
| Short-term liabilities | |||
| Liabilities to subsidiaries | – | 9,296 | 639 |
| Trade payables | 18,809 | 15,119 | 13,906 |
| Other liabilities | 10,431 | 8,296 | 3,576 |
| Accrued expenses and deferred income | 85,597 | 75,870 | 78,297 |
| Total short-term liabilities | 114,837 | 108,581 | 96,418 |
| TOTAL EQUITY AND LIABILITIES | 639,159 | 646,101 | 685,735 |
| Cash and cash equivalents Cash and cash bank balances |
Key figures, MSEK | 2020 Jan-Mar |
2019 Jan-Mar |
2019 Jan-Dec |
|---|---|---|---|---|
| Equity ratio, percent | ||||
| Equity divided by total capital | Net revenues | 49.3 | 18.5 | 105.6 |
| Weighted average number of shares, before dilution Weighted average number of shares before adjustment for dilution effect of net shares |
Operating expenses | -117.3 | -99.4 | -443.2 |
| Operating result Result for the period |
-76.9 -61.6 |
-84.4 -67.6 |
-360.0 -289.9 |
|
| Cash flow from operating activities | -65.7 | -90.5 | -404.4 | |
| Weighted average number of shares, after dilution | Cash and cash equivalents | 291.3 | 406.6 | 358.7 |
| Weighted average number of shares adjusted for the dilution | Equity | 570.5 | 561.2 | 631.6 |
| effect of new shares | Equity ratio in Group, percent | 78% | 80% | 82% |
| Earnings per share before dilution, SEK | Total assets | 730.4 | 703.4 | 772.0 |
| Result divided by the weighted average number of shares | Weighted average number of shares, before dilution*) | 51,636,858 | 41,824,062 | 46,496,256 |
| outstanding before dilution | Weighted average number of shares, after dilution*) | 53,558,152 | 43,457,433 | 48,601,481 |
| Earnings per share before dilution, SEK*) | -1.19 | -1.62 | -6.23 | |
| Earnings per share after dilution, SEK | Earnings per share after dilution, SEK*) | -1.19 | -1.62 | -6.23 |
| Result divided by the weighted average number of shares | Equity per share before dilution, SEK*) | 11.05 | 13.42 | 13.58 |
| outstanding after dilution | Equity per share after dilution, SEK*) | 10.65 | 12.91 | 13.00 |
| Equity per share before dilution, SEK | Number of employees at end of period | 127 | 103 | 120 |
| Equity divided by the weighted average number of shares at | Number of employees in R&D at end of period | 74 | 62 | 67 |
| the period before dilution | R&D costs as a percentage of operating expenses | 59% | 55% | 56% |
| Equity per share after dilution, SEK | ||||
Equity divided by the weighted average 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, regarding 2019, is calculated according to IAS 33
Camurus AB, Corp. ID No. 556667-9105 is the parent company of the Camurus Group and has its registered office based in Lund, Sweden, at Ideon Science Park, 223 70 Lund. Camurus AB Group's interim report for the first quarter 2020 has been approved for publication by the Board of Directors and the chief executive officer.
All amounts are stated in SEK thousands (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 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 for the Group, unless otherwise stated in Note 2.2.
The most important accounting policies that are applied in the preparation of these consolidated financial statements are detailed below and are the same and consistent with those used in the preparation of Annual Report 2019, see camurus.com/Investors/Financial Reports.
No new or revised IFRS standards, with any material impact on the Group, have come into force.
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.
IFRS 9 "Financial instruments" addresses the classification, measurement and recognition of financial assets and liabilities and is applied with the exceptions that RFR2 allows, i.e. at amortized cost.
Camurus has three 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. The stay-on bonus is conditional on continued employment. Costs including social security fee, are based on how much has been earned, and are expensed over the vesting period. Expenses are recognized as personnel cost in the income statement. The programs were adopted by the Annual General Meeting in 2017, 2018 and 2019.
| Program | Number of sub scribed warrants |
Potential dilution of the sub scribed warrants |
Subscription period |
Strike price SEK, for sub scription of shares upon exercise |
Market value3) | Number of employees partici pating in the program |
|---|---|---|---|---|---|---|
| TO2017/2020 | 715,8161,2) 1.39%1,2) 15 May 2020- | 153.911) 15 May 2017: 17.00 SEK | 44 | |||
| 15 Dec 2020 | 19 Sep 2017: 15.60 SEK | |||||
| TO2018/2021 | 605,5191,2) | 1.17%1,2) 15 May 2021- | 133.391) 14 May 2018: 12.83 SEK | 46 | ||
| 15 Dec 2021 | 20 Aug 2018: 9.94 SEK | |||||
| TO2019/2022 | 599,9592) | 1.16%2) 15 May 2022- | 98.90 | 3 Jun 2019: 11.10 SEK | 64 | |
| 15 Dec 2022 | ||||||
| Totalt | 1,921,294 | 3.72% |
1) After recalculation of TO2017/2020 and TO2018/2021, which was called for in accordance with the terms of the programs due to the rights issue in March 2019. Prior to recalculation, the total number was 1,816,291, corresponding to a dilution effect of 3.52 percent.
2) No further allocation can be made.
3) The warrants were valued by in accordance with the Black&Scholes model. Data used in the valuation are volatility in the share, dilution effect, subscription price at exercise, interest rate and the term for the warrants.
The Company management makes estimates and assumptions about the future. Such estimates can deviate considerably from the actual outcome, since they are based on various assumptions and experiences.
The estimates and assumptions that may lead to the risk of significant adjustments to reported amounts for assets and liabilities relate mainly to measurement and allocation of revenues and costs in connection with licensing agreements and deferred tax receivables. Risks in ongoing development projects comprise technical and manufacturing related risks (including products failing to meet set specifications post manufacturing), safety and effect-related risks that can arise in clinical trials, regulatory risks relating to non-approval or delays of clinical trial applications and market approvals, and commercial risks relating to the sale of proprietary and competing products and their development on the market, as well as IP risks relating to approval of patent applications and patent protection. In addition, there are risks relating to the development, strategy and management decisions of Camurus' partners. Camurus pursues operations and its business on the international market and the Company is therefore exposed to currency risks, since revenues and costs arise in different currencies, mainly AUD, EUR, GBP, SEK and USD.
The Group reports a deferred tax asset of MSEK273.2 MSEK as of 31 March, 2020. The deferred tax asset is calculated on the basis that Camurus AB's entire losses carried forward will be utilized against taxable surpluses in the future. The basic circumstance leading the Company to make this assessment is that the Company, for the development of new drug candidates, utilizes its own proprietary and regulatory validated long-acting FluidCrystal® injection depot. By combining this technology with already existing active drug substances whose efficacy and safety profile previously has been documented, new proprietary drugs with improved properties and treatment results can be developed in shorter time, at a lower cost and risk compared to the development of completely new drugs.
Accounting for deferred tax assets according to IFRS requires that it is probable that taxable surpluses will be generated in the future which the losses carried forward can be used against. In addition, a company that has reported losses in recent periods must be able to demonstrate convincing factors that taxable
profits will be generated. The progress made in the development of CAM2038 for the treatment of opioid dependence (Phase 3 studies and regulatory approvals) and success in previous projects using FluidCrystal injection depot is what convincingly suggests that the Company will be able to utilize its losses carried forward. The fact that the Company has reported losses is natural in an industry where it takes considerable time to develop and launch new products, even when these are based on a proven technology and substances that are well-proven. We see the European Commission approval of Buvidal® for treatment of opioid dependence on November 22, 2018, Australian TGA's approval on November 28, 2018, the launch of Buvidal in EU and Australia, and the FDA's tentative approval for Brixadi™, weekly and monthly depot on December 21, 2018 (meaning that Brixadi has met all regulatory requirements but that a final approval of Brixadi (monthly depot) is dependent on the expiry of an exclusivity period which may not last longer than until November 2020), as further validation of our formulation technology FluidCrystal, and are events that confirm the likelihood assessments made by the Company when calculating the amount of the deferred tax asset.
Future revenues will be generated from Camurus' own sales organization in markets where Camurus have own commercialization capabilities to sell pharmaceuticals and through partnerships for markets where Camurus has out-licensed FluidCrystal and/or product candidates or products such as Buvidal.
Losses carried forward are only reported in Sweden and without any due dates based on current tax legislation in Sweden.
A more detailed description of the Group's risk exposure is included in Camurus Annual Report 2019 (The Director's Report).
The Board of Directors has not changed its outlook on future developments in relations to their outlook published in the Annual Report 2019.
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.
| Revenues allocated by products and services |
2020 Jan-Mar |
2019 Jan-Mar |
2019 Jan-Dec |
|---|---|---|---|
| Sales of development related goods and services | 619 | 1,661 | 7,001 |
| Licensing revenues and milestone payment | 63 | 5,865 | 26,520 |
| Product sale1) | 48,614 | 10,968 | 72,084 |
| Total | 49,296 | 18,494 | 105,605 |
| 1) Related to Buvidal and episil | |||
| Revenues allocated by geographical area |
2020 Jan-Mar |
2019 Jan-Mar |
2019 Jan-Dec |
Europe 31,967 11,313 61,426 (whereof Sweden) (2,399) (259) (4,028) North America 678 1,309 24,803 Asia including Oceania 16,651 5,872 19,376 Total 49,296 18,494 105,605
Revenues during the quarter of approximately MSEK 23.9 (10.5) relate to one single external customer.
99.8 (99.7) percent of the Group's 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.
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 | 2020 | 2019 | 2019 |
|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | |
| Result attributable to Parent Company shareholders Weighted average number of ordinary shares outstanding (thousands) |
-61,552 51,637 |
-67,626 38,915 |
-289,865 45,950 |
| KSEK | 2020 Jan-Mar |
2019 Jan-Mar |
2019 Jan-Dec |
|---|---|---|---|
| Result attributable to Parent | |||
| Company shareholders | -61,552 | -67,626 | -289,865 |
| Weighted average number of | |||
| ordinary shares outstanding (thousands) | 51,637 | 38,915 | 45,950 |
| Adjustment for fund issue | |||
| element1) (thousands) | – | 2,909 | 546 |
| Weighted average number of | |||
| ordinary shares outstanding (thousands) | 51,637 | 41,824 | 46,496 |
| Adjustment for | |||
| warrants (thousands) | 1,921 | 1,633 | 2,105 |
| Weighted average number of | 53,558 | 43,457 | 48,601 |
| ordinary shares used in calculation of | |||
| earnings per share after dilution (thousands) |
1) The number of shares has been recalculated according to the so-called fund issue element in accordance with IAS 33, p. 26 and 64
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 outside of the Camurus Group during the period.
No receivables or liabilities existed as of 31 March, 2020.
| Balance sheet assets, KSEK | 31-03-2020 | 31-03-2019 | 31-12-2019 |
|---|---|---|---|
| Trade receivables | 41,597 | 5,452 | 34,791 |
| Cash and cash equivalents | 291,301 | 406,622 | 358,744 |
| Total | 332,898 | 412,074 | 393,535 |
| Balance sheet liabilities, KSEK | |||
| Trade payables | 20,968 | 16,837 | 17,387 |
| Other liabilities | 190 | 190 | 190 |
| Total | 21,158 | 17,027 | 17,577 |
Adjustment for non-cash items:
KSEK
Tax income for the quarter amounted to MSEK 15.7 (17.2), primary attributable to the negative result.
| Note 10 | Equity |
|---|---|
| --------- | -------- |
The change in equity for the quarter is mainly attributable to the loss during the period.
2020 Jan-Mar
Depreciation 2,469 2,156 9,014 Total 2,469 2,156 9,014
2019 Jan-Mar
2019 Jan-Dec
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, 1.00 PM (CET) on 7 May, 2020.

Camurus AB | Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 | F +46 46 286 57 39 | [email protected] | camurus.com
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.