Interim / Quarterly Report • Jul 16, 2021
Interim / Quarterly Report
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INTERIM REPORT FOR THE SECOND QUARTER 2021
"Significant progress on key objectives with increasing revenues, new regulatory approvals, and a potential US market authorization in 2021"
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 unique 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' share is listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit camurus.com
1) At constant exchange rates in January 2021.
2) Excluding US\$35 million milestone payment on approval of Brixadi™ in the US.
| MSEK | 2021 Apr-Jun |
2020 Apr-Jun |
% ∆ | 2021 Jan-Jun |
2020 Jan-Jun |
% ∆ | 2020 Jan-Dec |
|---|---|---|---|---|---|---|---|
| Total revenue | 138 | 81 | 71% | 264 | 130 | 103% | 336 |
| whereof product sales | 137 | 76 | 80% | 261 | 124 | 110% | 323 |
| OPEX | 179 | 102 | 75% | 315 | 219 | 44% | 508 |
| Operating result | -60 | -23 | -156% | -86 | -100 | 14% | -205 |
| Result for the period | -48 | -20 | -142% | -70 | -82 | 14% | -167 |
| Result per share, before and after dilution, of SEK | -0.89 | -0.39 | -130% | -1.29 | -1.58 | 18% | -3.18 |
| Cash position | 422 | 222 | 90% | 422 | 222 | 90% | 462 |
Total revenue SEK 138 million +71%
Product sales SEK 137 million +80%
Operating result SEK -60 million -156%
Financial analysts, investors and media are invited to attend a telephone conference and presentation of the 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/13366

Camurus had a productive second quarter with increasing revenues, new regulatory approvals, progress in the development portfolio, and the publication of strong data in leading scientific journals. Product sales increased by 80% compared to the same quarter in 2020, and 10% compared to the first quarter of this year. The increase was weaker than expected, due to the continued impact of the COVID-19 pandemic on our markets in Europe and Australia. We expect to return to planned growth in the second half of the year as restrictions ease and Buvidal is launched in new markets. In the US, we are now looking forward to the possibility of Brixadi becoming available to US patients by the end of the year after the FDA set a target date for approval to December 15, 2021.

Camurus' total revenues during the second quarter increased to SEK 138 million and operating result was SEK -60 million. Operating expenses increased with 75% compared to previous year, linked to the progress of our registration programs of CAM2029 in acromegaly, neuroendocrine tumors and polycystic liver disease. For the interim period January-June, revenues amounted to SEK 264 million and operating result to SEK -86 million, an improvement of 14% compared to 2020.
With increasing product sales and further significant revenue opportunities in the near future, as well as a cash balance of SEK 422 million, we have a strong base to achieve our strategic goals for growth and to bring new drug candidates in our research portfolio to the market.
Product sales during the second quarter were SEK 137 million, an increase of 80% compared with a strong second quarter in 2020.
During the second quarter, we saw good sales growth in established markets that were spared from significant consequences of the COVID-19 pandemic, while a temporary slowdown was seen in markets where closures and restrictions hindered direct contacts with prescribers and healthcare professionals, and patients access to clinics for new initiations were limited. The pandemic has also led to protracted processes for pricing and reimbursement and the granting of various approvals, which has pushed
launches for example in the Netherlands and Switzerland from the second to the third quarter.
With over 19,000 patients estimated in treatment with Buvidal at the end of the quarter, we have established a leading market position among long-term buprenorphine treatments in just over 2 years. The average market share of total number of patients in opioid dependence treatment in our existing markets is about 5%, ranging from approximately 2% in Germany and the UK, to between 10-20% in Scandinavia and Australia. In Finland, the patient share is now over 60% and more patients are getting access to treatment, driven by Buvidal.
In addition, during the quarter we prepared for launch of Buvidal in further seven European markets, including France, Switzerland and Benelux, which together have around 220,000 patients in opioid dependence treatment.1
During the quarter, we continued our efforts to establish Buvidal as evidence-based first choice for individualized treatment of opioid dependence. We received market approval for a higher 160mg dose of Buvidal in Australia, the EU and UK, which will start to be introduced on our markets during the third quarter. In Australia, an extension of the indication for Buvidal was also approved which allows direct initiation of treatment with Buvidal without the need for stabilization with daily dosed sublingual buprenorphine – as it is currently indicated in the EU.
The scientific evidence base for Buvidal was further strengthened with new publications in leading scientific journals. Results from the randomized, controlled DEBUT study published in JAMA Network Open showed significantly higher patient-reported satisfaction and quality of life with Buvidal compared to standard daily treatment. The UNLOC-T study, which was published in the leading addiction journal Addiction, showed positive treatment results and the benefits of using Buvidal in custodial setting.2,3
We have seen growing interest in Buvidal from governments, policy makers and media resulting in new initiatives and increased funding for innovative and "game-changing" treatments for opioid dependence. These have received wide coverage in published reports and in national and regional news.
Important and welcome news during the quarter was the announcement that our US licensee Braeburn has submitted an updated New Drug Application (NDA) for market approval for Brixadi (the US tradename for Buvidal) to the Food and Drug Administration (FDA). The authority announced shortly afterwards that the filing had been accepted with a Prescription Drug User Fee Act (PDUFA) set for December 15, 2021.
In addition to the NDA review process, several investigator-lead clinical trials are also underway in the US, which together will include over 2,000 patients and contribute to an increased knowledge of the value of our treatment in various clinical applications.
With an estimated two million individuals diagnosed with opioid dependence, approximately ten million people misusing opioids, and 60,000 annual overdose deaths related to opioides, there is an urgent need for effective opioid treatment in the US.4 The opioid crisis has escalated during the COVID-19 pandemic and the Biden Government has taken important initiatives to curb the crisis, including allocating USD 1.5 billion for the prevention and treatment of opioid dependence.
"The scientific evidence base for Buvidal was further strengthened with new publications in leading scientific journals"
It is very gratifying that US patients, upon approval, will have access to a new effective treatment for opioid dependence which offers flexible weekly and monthly dosing that can be easily adapted to the individual's own needs. Based on our experience from Europe and Australia and interactions with experts in the US, we believe that Brixadi has the potential to gain a significant share of the opioid dependence market in the US.
During the quarter, we continued to prepare the application for market authorization of CAM2038 for the treatment of chronic pain. The goal is to submit the application to the European Medicines Agency (EMA) in the fourth quarter with the possibility of market approval during the second half of 2022.
In parallel, patient recruitment and treatment continued in our two Phase 3 studies of octreotide subcutaneous depot, CAM2029, in patients with acromegaly. Topline results from both studies are expected in 2022.
Preparations were also completed for start of a pivotal Phase 3 study of CAM2029 for the treatment of neuroendocrine tumors, where we expect the first patients to be enrolled and start treatment after the summer.
In addition, we are in the process of completing a bridging pharmacokinetic study of CAM2029 which characterizes pharmacokinetics, pharmacodynamics, and tolerability when dosing with our newly developed injection pen (autoinjector) and the prefilled syringe. Topline results from the single-dose part of the study are expected in then second half of 2021.
The recruitment of patients in the Phase 2 study of CAM2043 for treatment of Raynaud's phenomenon, expected to be completed later in the year, was also resumed.
Collaborative development projects, among others with Rhythm and UCB, continued to progress and we look forward to the start of the pivotal phase 3 program for setmelanotide weekly depot, CAM4072, for the treatment of patients with genetically determined obesity during the second half of the year.
In the second quarter, Camurus made significant progress on key objectives with increasing revenues, new regulatory approvals, and a potential US market authorization in 2021.
Considering the challenging conditions in many of our markets , I am pleased with the results and proud of the commitment and goal-focused work done by our employees and partners to increase access to Buvidal. We are positive about the continued development and opportunity for accelerated growth during the second half of the year as we expect the impact of the pandemic to wane.
In addition, there are further significant opportunities for Buvidal in chronic pain, in our broad development portfolio and different partnerships.
The work of building Camurus' organization continues and during the quarter we had the pleasure of welcoming new skilled and experienced employees to the company, including Arnaud Vesin as general manager for France and Mozhgan Dorkhan as medical director for endocrinology. Furthermore, receiving the Carnegie Sustainability Award was a positive recognition of our joint long-term commitment to patients and society.
Fredrik Tiberg, President and Chief Executive Officer
"We are positive about the continued development and opportunity for accelerated growth during the second half of the year as we expect the impact of the pandemic to wane"
European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), European Drug Report 2021: Trends and Developments. Accessible on: https:// www.emcdda.europa.eu/system/files/publications/ 13838/TDAT21001ENN.pdf
Lintzeris, N., et al. Patient-Reported Outcomes of Treatment of Opioid Dependence With Weekly and Monthly Subcutaneous Depot vs Daily Sublingual Buprenorphine. A Randomized Clinical Trial. JAMA Network Open. 2021;4(5):e219041. Doi:10.1001/ jamanetworkopen.2021.9041. Accessible on: https:// jamanetwork.com/journals/jamanetworkopen/ fullarticle/2779751.
Dunlop, A.J., et al. Treatment of opioid dependence with depot buprenorphine (CAM2038) in custodial settings. Addiction. 2021 Jun 29. doi: 10.1111/add.15627. Online ahead of print.
CDC, Centers for Disease Control and Prevention, Provisional Drug Overdose Death Counts. https:// www.cdc.gov/nchs/nvss/vsrr/drug-overdosedata.htm.
Camurus has a broad and diversified product and pipeline portfolio of innovative medicines from earlystage development to marketed products. For the development of new drug candidates we combine our injection depot technology, FluidCrystal®, with active substances with clinically documented efficacy and safety profiles. As a result, new proprietary medicines with improved treatment outcomes and patient benefits can be developed both in a shorter time and to a lower costs, as well as with lower risk compared to the development of new chemical substances. The aim is to bring forward new treatments that make a real difference to patients, care givers, healthcare systems and society by contributing to substantial improvements in treatment outcomes, increased quality of life and effective utilization of healthcare resources. Focus is on the three disease areas i) opioid dependence and chronic pain, ii) rare diseases and iii) oncology and supportive care.

Opioid dependence is a serious, chronic, relapsing disease and a growing global health problem. Pharmacological treatment is often daily buprenorphine or methadone and whilst effective, these treatments have significant limitations, such as poor treatment adherence, misuse, medication diversion and accidental pediatric exposure.
Buvidal (buprenorphine) injection depot is used for the treatment of opioid dependence in adults and adolescents aged 16 years and over, within a framework of medical, social and psychological treatment. The long-acting subcutaneous treatment is available both as weekly and monthly formulations as well as in multiple dose options, offering flexibility and enables treatment to be modified to each patient's specific needs and circumstances. Buvidal gives both a fast onset and a long-acting effect, effectively reducing patients' withdrawal symptoms and cravings, and by blocking the effect of other opioids, has potential to protect against overdose.
The extensive clinical development programs leading to market approval demonstrated a significant improved treatment effect with Buvidal compared to daily administrated sublingual buprenorphine and also a favorable safety profile. Also, clinical studies have shown high patient satisfaction, treatment retention and a good safety profile similar to established profile for buprenorphine products, apart from mild to moderate injection site reactions.

The strong performance with Buvidal continued with further growth in established markets and new regulatory approvals of the 160mg monthly dose and direct treatment initiation on Buvidal in Australia, as well as approval of the 160mg monthly dose in the EU by the European Commission and approval in the UK. In the US, Camurus' licensee Braeburn resubmitted the New Drug Application (NDA) for Brixadi™* (buprenorphine) extended-release weekly and monthly injections to the US Food and Drug Administration (FDA), which was in response to the Complete Response Letter (CRL) received in December 2020. The NDA was accepted and the Prescription Drug User Fee Act (PDUFA) action date is set for 15 December 2021.
In addition, during the quarter the scientific evidence for Buvidal further strengthened with publication in the JAMA Network Open of the 24-week, randomized, controlled DEBUT study, showing superior patient reported treatment satisfaction as well as statistically reduced treatment burden and improved quality of life with Buvidal versus treatment with daily sublingual buprenorphine. Furthermore, the UNLOC-T study was published in Addiction, showing positive treatment results for Buvidal when used within custodial setting.
* Brixadi™ is the US trade name for Camurus' product Buvidal®

CAM2038 is being developed to provide round-the-clock pain relief. While decreasing the risk of respiratory depression and fatal overdoses associated with full l u-opioid agonists, CAM2038 has at the same time the potential to protect against misuse, abuse and diversion. CAM2038 is primarily addressing needs for opioid experienced 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 pivotal Phase 3 study in opioid experienced patients with chronic low-back pain, in which the study met both the primary and first secondary endpoints. The subsequant long-term safety study also included patients with other chronic pain conditions. Study results demonstrated a safety profile of CAM2038 generally consistent with the known safety profile of buprenorphine and no unexpected adverse events were observed.
Preparation of the regulatory application in the EU is continued with planned submission to EMA in the second half of 2021.
CAM2029 is a long-acting subcutaneous depot of octreotide in late-stage development for the treatment of acromegaly and neuroendocrine tumors (NET). CAM2029 provides significantly higher octreotide bioavailability and octreotide exposure with the potential for improved treatment efficacy, compared to current market leading product. CAM2029 is developed to enable easy self-administration by patients, using a prefilled syringe with automatic needle cap or a prefilled pen device.

CAM2029 has been studied in four Phase 1 and 2 studies, in acromegaly and NET patients as well as in healthy volunteers, with positive results. Two pivotal Phase 3 studies in patients with acromegaly are currently ongoing and an additional Phase 3 study for the treatment of neuroendocrine tumors has recently been initiated.
Recruitment and treatment of patients in the two ongoing Phase 3 studies for the treatment of acromegaly continued during the quarter. Overall results from the pivotal efficacy study and the safety study are expected in 2022.
Earlier this year, FDA issued a IND Safe to Proceed Letter for start of a pivotal Phase 3 study of CAM2029 for the treatment of NET. The preparations for the start of the study have now been completed. Randomization and treatment of patients in the Phase 3 study is expected to start after the summer of 2021.
An IND application for a Phase 2/3 study for the treatment of polycystic liver disease (PLD) has been submitted to the FDA.

CAM2043 is a long-acting subcutaneous treprostinil formulation developed as a patient-friendly and effective treatment option for people with pulmonary arterial hypertension (PAH) or Raynaud's phenomenon (RP). Besides providing less frequent administration and avoid the need for continuous infusion, CAM2043 can reduce the risks associated with current parenteral products for PAH, such as infusion related reactions, or the limitations caused by continuously having to carry an infusion pump. CAM2043 has been investigated in a completed open-label Phase 1 trial.
The Phase 2 clinical study of CAM2043 for the treatment of Raynaud's phenomenon was reinitiated after being temporarily stalled due to the COVID-19 lockdown in the UK. The study recruitment is ongoing and the study is expected to be completed within 2021. In parallel, planning and preparation for further clinical development of CAM2043 in RP and PAH indications is ongoing.
CAM4072 is a weekly formulation of the MC-4 agonist setmelanotide, developed together with our partner Rhythm Pharmaceuticals for the treatment of a range of rare genetic disorders of obesity. During the summer 2020, positive results were reported from a Phase 2 study for CAM4072. Study results in healthy volunteers with severe obesity demonstrated that treatment effect with the weekly formulation were comparable to the effect achieved with daily injections of setmelanotid.
Rhythms' short-acting formulation of setmelanotide, Imcivree™, was approved by the FDA in November 2020 for the treatment of rare obesity disorders related to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. This was followed by positive CHMP opinion end May 2021, recommending marketing authorization approval within the EU for setmelanotide for treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiency.
Rhythm is preparing for start of the pivotal Phase 3 clinical program for CAM4072 during the second half of 2021.
CAM2032 is a long-acting subcutaneous leuprolide depot candidate 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. During the quarter, a collaborative project was initiated with a partner for evaluation and possible furthter development of the product candidate.
CAM2047 is being developed as a long-acting subcutaneous granisetron depot for the treatment of both acute and delayed chemotherapy-induced nausea and vomiting (CINV), a side effect experienced by a large number of cancer patients. CAM2047 has been successfully evaluated in a completed Phase 1 trial.
CAM2048 is a buprenorphine depot formulation for the treatment of postoperative pain providing rapid onset of action and therapeutic levels of buprenorphine over a couple of days. CAM2048 is being developed in collaboration with Braeburn Pharmaceuticals and has been evaluated in a completed Phase 1 trial.
CAM4071 is a long-acting formulation of pasireotide, a substance currently approved for the treatment of Cushing's syndrome and acromegaly as a second line treatment. CAM4071 has been studied in a completed dose escalating Phase 1 study, which evalutated pharmacokinetics, pharmacodynamics and safety in healthy volunteers.
During the second quarter, we completed the formulation optimization of CAM4071 in regards to long-term stability and now have a fomulation for continued clinical development.
CAM4083 is a long-acting formulation of the complement protein C5-inhibitor zilucoplan, which is being developed by our partner UCB for the treatment of generalized myasthenia gravis and other serious tissue-based complementmediated disorders. During the quarter, preparations for the start of the clinical development program continued.
episil® oral liquid is used for the treatment of inflammatory and painful conditions in the oral cavity, such as oral mucositis (OM) - a common 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, and the UK, and through distribution partners in other countries, including Japan, China, South Korea and Australia.
In May 2021, Camurus' partner Solasia Pharma K.K announced that episil has been included in the first OM guidelines released in China. In the guidelines, developed by the Chinese Society of Clinical Oncology (CSCO), episil is recommended as standard treatment for OM.


Total revenues during the quarter amounted to MSEK 137.9 (80.9), an increase by 71 percent (72 percent at CER1 ).
Product sales were MSEK 136,6 (75.8), corresponding to an increase of 80 percent (82 percent at CER) compared to Q2 2020 and an increase by 10 percent (10 percent at CER) compared to the previous quarter.
Half-year total revenues were MSEK 263.8 (130.2), up 103 percent compared to the same period 2020. Product sales were MSEK 260,9 (124.4), up 110 percent. For further information, see Note 4.
Marketing and distribution costs in the quarter were MSEK 55.5 (41.9), and for the half-year MSEK 100.0 (84.1), an increase primarily linked to launches and product sales of Buvidal® in Europe and Australia as well as expansion to new markets.
Administrative expenses for the quarter were MSEK 6.2 (9.9) and for the halfyear MSEK 16.0 (16.3).
R&D costs, including depreciation and amortization of tangible and intangible assets, were MSEK 117.0 (50.2) and for the half-year MSEK 198.9 (118.9). The increase compared to previous year is mainly linked to the progress in the three ongoing pivotal Phase 3 programs of CAM2029 for the treatment of acromegaly, neuroendochrine tumors and polycystic liver disease.
As an effect of the increased costs, primarily within R&D, the operating result for the quarter amounted to MSEK -59.8 (-23.3), and for the half-year MSEK -86.1 (-100.3).
Financial items in the period were MSEK -0.3 (-0.3) and MSEK -0.6 (-0.7) for the first half of the year.
Tax in the quarter was MSEK 11.7 (3.7) and for January-June MSEK 16.4 (19.4), an income mainly representing deferred tax for the reported loss during the period.
The result for the period amounted to MSEK -48.4 (-20.0) and for the half-year MSEK -70.3 (-81.5). Earnings per share, before and after dilution, were SEK -0.89 (-0.39) and for the the half-year SEK -1.29 (-1.58).
Cash flow from operating activities, before change in working capital, amounted to MSEK -56.0 (-22.2) and MSEK -80.0 (-97.4) for the half-year.
The change in working capital affected the cash flow by MSEK 14.7 (-44.0) in the quarter and during the half-year by MSEK -22.0 (-34.5).
Cash flow from investing activities in the quarter was MSEK -1.3 (-0.7) and MSEK -1.6 (-1.3) year to date.
From financing activities cash flow was MSEK 38.4 (-1.1) in the quarter which mainly relates to exercise of warrants in TO2018/2021. During the half-year it was MSEK 65.3 (-2.2) and relates both to exercise of warrants in TO2018/2021 and to payments for exercise of TO2017/2020 in December 2020, which were received by the company during the first quarter 2021.
The cash position for the group as of 30 June, 2021 was MSEK 421.9 (222.0). There were no loans as of 30 June, 2021 and no loans have been taken up since.
Consolidated equity as of 30 June, 2021 was MSEK 819.7 (549.6). The difference compared to last year is due to the result for the period, the directed share issue in July 2020, and the exercise of warrants in the warrant programs TO2017/2020 and TO2018/2021.
Total assets for the group were MSEK 1,046 (723).
The company's total revenue in the quarter amounted to MSEK 133.4 (82.6) and in the first half year MSEK 253.5 (135.1). The result after tax in the quarter was MSEK -51.2 (-20.8) and for January-June MSEK -76.1 (-85.8).
On 30 June, 2021, equity in the parent company amounted to MSEK 757.8 (499.5) and total assets to MSEK 929.3 (629.4), of which MSEK 380.1 (190.0) were cash and cash equivalents.
During the quarter a wholly owned subsidiary was established in Austria.
Camurus' share is listed on Nasdaq Stockholm.
At the end of the period, the total number of shares and votes was 54,538,571 (51,636,858). The difference compared to last year relates to the directed share issue completed in July 2020 and new shares issued through exercise of warrants in the subscription warrant program TO2017/2020 during fourth quarter 2020 and TO2018/2021 during the second quarter 2021.
Currently Camurus has four long-term share-based incentive programs ongoing for the company's employees; three subscription warrant programs and one employee option program which was launched 10 June, 2021. During the quarter and January-June, earnings after tax was negatively impacted by MSEK 0.9 and MSEK 2.5 after tax respectively related to the stay-on bonus the participants receive as part of the subscription warrant program. Corresponding impact, without any cash flow effect, for the employee option program was MSEK 1.6 during both the quarter and the first half-year. For further information about the programs, see Note 2.3.
At the end of the period, Camurus had 140 (132) employees, of whom 77 (77) were within research and development and medical affairs, 48 (43) within business development and marketing and sales, while 14 (11) were within administration. The number of employees, in terms of full-time equivalents, amounted to 127 (118) during the quarter and 125 (115) during the first six months.
The financial outlook for 2021 is maintained based on the expected product sales and revenue growth in the second half of the year as the impacts of COVID-19 continue to wane: Total revenue SEK 680 – 750 million, whereof product sales SEK 620 – 680 million, and an operating result SEK -120 – 0 million.
The outlook is based on exchange rates in January 2021 and excludes milestone payments related to the approval of Brixadi™ in the United States.
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.
Q3 2021 4 November, 2021
For further information, please contact: Fredrik Tiberg, President and CEO Tel. +46 46 286 46 92, e-mail: [email protected]
The Board of Directors and the CEO certify that this interim report gives a true and fair view of the company's and groups' operations, financial position and results and describes significant risks and uncertainties that the company and the subsidiaries included in the group face.
Lund, Sweden, 14 July, 2021
Camurus AB
Per-Olof Wallström Chairman of the Board
Hege Hellström Board Member
Kerstin Valinder Strinnholm Board Member
Behshad Sheldon Board Member
Jakob Lindberg Board Member
Ole Vahlgren Board Member Fredrik Tiberg President and CEO, Board Member
This interim report has not been reviewed by the company's auditors.
| KSEK Note |
2021 Apr-Jun |
2020 Apr-Jun |
2021 Jan-Jun |
2020 Jan-Jun |
2020 Jan-Dec |
|---|---|---|---|---|---|
| Total revenue 4 |
137,895 | 80,872 | 263,792 | 130,168 | 335,997 |
| Cost of goods sold | -20,592 | -4,376 | -36,264 | -12,156 | -35,284 |
| Gross profit | 117,303 | 76,496 | 227,528 | 118,012 | 300,713 |
| Operating expenses | |||||
| Marketing and distribution costs Administrative expenses |
-55,453 -6,205 |
-41,948 -9,861 |
-99,987 -16,014 |
-84,123 -16,324 |
-171,821 -97,581 |
| Research and development costs | -116,957 | -50,249 | -198,948 | -118,905 | -238,678 |
| Other operating income | 1,526 | 2,240 | 1,302 | 1,090 | 2,135 |
| Operating result | -59,786 | -23,322 | -86,119 | -100,250 | -205,232 |
| Finance income | 43 | 55 | 85 | 109 | 194 |
| Finance expenses | -330 | -371 | -662 | -763 | -1,541 |
| Net financial items | -287 | -316 | -577 | -654 | -1,347 |
| Result before tax | -60,073 | -23,638 | -86,696 | -100,904 | -206,579 |
| Income tax 9 |
11,684 | 3,678 | 16,433 | 19,392 | 39,314 |
| Result for the period1) 5 |
-48,389 | -19,960 | -70,263 | -81,512 | -167,265 |
| Other comprehensive income | |||||
| Exchange-rate differences | -607 | -920 | 705 | -480 | -1,390 |
| Comprehensive income for the period | -48,996 | -20,880 | -69,558 | -81,992 | -168,655 |
1) All attributable to parent company shareholders.
| 2021 | 2020 | 2021 | 2020 | 2020 | |
|---|---|---|---|---|---|
| Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Jan-Dec | |
| Earnings per share before dilution, SEK | -0.89 | -0.39 | -1.29 | -1.58 | -3.18 |
| Earnings per share after dilution, SEK | -0.89 | -0.39 | -1.29 | -1.58 | -3.18 |
For more information about calculation of earnings per share, see Note 5.
Presently, the company has four long-term share-based incentive programs active.
For further information see page 15 Camurus' share, and Note 2.3.
| KSEK Note |
30-06-2021 | 30-06-2020 | 31-12-2020 |
|---|---|---|---|
| ASSETS Fixed assets |
|||
| Intangible assets | |||
| Capitalized development expenditure | 34,980 | 36,798 | 36,597 |
| Tangible assets | |||
| Lease assets | 22,350 | 25,264 | 25,094 |
| Equipment | 8,751 | 9,930 | 8,805 |
| Financial assets | |||
| Deferred tax receivables | 9 324,909 |
278,376 | 305,116 |
| Total fixed assets | 390,990 | 350,368 | 375,612 |
| Current assets | |||
| Inventories | |||
| Finished goods and goods for resale | 58,880 | 54,023 | 69,345 |
| Raw material | 47,000 | 28,230 | 42,004 |
| Total inventories | 105,880 | 82,253 | 111,349 |
| Current receivables | |||
| Trade receivables | 101,974 | 46,438 | 52,191 |
| Other receivables | 16,345 | 13,834 | 35,490 |
| Prepayments and accrued income | 8,649 | 8,482 | 7,663 |
| Total current receivables | 6 126,968 |
68,754 | 95,344 |
| Cash and cash equivalents | 421,894 | 222,004 | 461,793 |
| Total current assets | 654,742 | 373,011 | 668,486 |
| TOTAL ASSETS | 1,045,732 | 723,379 | 1,044,098 |
| KSEK Note |
30-06-2021 | 30-06-2020 | 31-12-2020 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| EQUITY | |||
| Equity attributable to | |||
| parent company shareholders | |||
| Share capital | 1,364 | 1,291 | 1,356 |
| Other contributed capital | 1,838,871 | 1,412,659 | 1,797,084 |
| Retained earnings, including | |||
| comprehensive income for the period | -1,020,557 | -864,336 | -950,999 |
| Total equity 10 |
819,678 | 549,614 | 847,441 |
| LIABILITIES | |||
| Long-term liabilities | |||
| Lease liabilities | 17,836 | 20,705 | 20,387 |
| Social security costs for employee options | 326 | – | – |
| Total long-term liabilities | 18,162 | 20,705 | 20,387 |
| Short-term liabilities | |||
| Trade payables | 31,603 | 31,366 | 20,712 |
| Lease liabilities | 5,101 | 4,444 | 5,094 |
| Income taxes | 7,505 | 4,807 | 2,839 |
| Other liabilities | 17,118 | 8,831 | 11,219 |
| Accrued expenses and deferred income | 146,565 | 103,612 | 136,406 |
| Total short-term liabilities 6 |
207,892 | 153,060 | 176,270 |
| TOTAL EQUITY AND LIABILITIES | 1,045,732 | 723,379 | 1,044,098 |
| Share | Other contri buted |
Retained earnings, inc. compr. inc. for |
Total | ||
|---|---|---|---|---|---|
| KSEK | Note | capital | capital | the period | equity |
| Opening balance 1 January, 2020 | 1,291 | 1,412,687 | -782,344 | 631,634 | |
| Comprehensive income for the period | – | – | -81,992 | -81,992 | |
| Transactions with shareholders | |||||
| Warrants issued | – | -28 | – | -28 | |
| Closing balance 30 June, 2020 | 1,291 | 1,412,659 | -864,336 | 549,614 | |
| Opening balance 1 January, 2020 | 1,291 | 1,412,687 | -782,344 | 631,634 | |
| Comprehensive income for the period | – | – | -168,655 | -168,655 | |
| Transactions with shareholders | |||||
| Directed share issue | 50 | 299,950 | – | 300,000 | |
| Exercise of warrants TO2017/2020 | 15 | 91,850 | – | 91,865 | |
| Issuance costs, net after deferred tax | – | -16,163 | – | -16,163 | |
| Warrants issued | – | 8,761 | – | 8,761 | |
| Closing balance 31 December, 2020 | 1,356 | 1,797,084 | -950,999 | 847,441 | |
| Opening balance 1 January, 2021 | 1,356 | 1,797,084 | -950,999 | 847,441 | |
| Comprehensive income for the period | – | – | -69,558 | -69,558 | |
| Transactions with shareholders | |||||
| Exercise of warrants | 8 | 40,681 | – | 40,689 | |
| Employee share options program | – | 1,262 | – | 1,262 | |
| Issuance costs, net after deferred tax | – | -399 | – | -399 | |
| Warrants issued | – | 243 | – | 243 | |
| Closing balance 30 June, 2021 | 10 | 1,364 | 1,838,871 | -1,020,557 | 819,678 |
| KSEK Note |
2021 Apr-Jun |
2020 Apr-Jun |
2021 Jan-Jun |
2020 Jan-Jun |
2020 Jan-Dec |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating profit/loss before financial items | -59,786 | -23,322 | -86,119 | -100,250 | -205,232 |
| Adjustments for non-cash items 8 |
4,624 | 2,585 | 7,619 | 5,054 | 11,551 |
| Interest received | 43 | 55 | 85 | 109 | 194 |
| Interest paid | -330 | -371 | -662 | -763 | -1,541 |
| Income taxes paid | -509 | -1,165 | -904 | -1,575 | -3,580 |
| Cashflow from operating activities before change | -55,958 | -22,218 | -79,981 | -97,425 | -198,608 |
| in working capital | |||||
| Increase/decrease in inventories | 3,358 | -45,200 | 5,469 | -49,161 | -78,257 |
| Increase/decrease in trade receivables | -8,308 | -4,841 | -49,783 | -11,647 | -17,400 |
| Increase/decrease in other current receivables | -5,321 | -9,001 | -9,268 | -9,253 | -2,663 |
| Increase/decrease in trade payables | -17,549 | 10,398 | 10,891 | 13,979 | 3,325 |
| Increase/decrease in other current operating liabilities | 42,531 | 4,645 | 20,724 | 21,557 | 54,771 |
| Cash flow from changes in working capital | 14,711 | -43,999 | -21,967 | -34,525 | -40,224 |
| Cash flow from operating activities | -41,247 | -66,217 | -101,948 | -131,950 | -238,832 |
| Investing activities | |||||
| Acquisition of intangible assets | -296 | -241 | -296 | -652 | -2,358 |
| Acquisition of tangible assets | -988 | -430 | -1,318 | -658 | -968 |
| Cash flow from investing activities | -1,284 | -671 | -1,614 | -1,310 | -3,326 |
| Financing activities Amortization of lease liabilities |
-1,283 | -1,105 | -2,551 | -2,181 | -4,782 |
| Share issue after issuance cost | 39,714 | – | 67,617 | – | 343,873 |
| Warrants issued | – | -28 | 243 | -28 | 8,761 |
| Cash flow from financing activities | 38,431 | -1,133 | 65,309 | -2,209 | 347,852 |
| Net cash flow for the period | -4,100 | -68,021 | -38,253 | -135,469 | 105,694 |
| Cash and cash equivalents at beginning of the period | 427,822 | 291,301 | 461,793 | 358,744 | 358,744 |
| Translation difference in cash flow and liquid assets | -1,828 | -1,276 | -1,646 | -1,271 | -2,645 |
| Cash and cash equivalents at end of the period | 421,894 | 222,004 | 421,894 | 222,004 | 461,793 |
| KSEK Note |
2021 Apr-Jun |
2020 Apr-Jun |
2021 Jan-Jun |
2020 Jan-Jun |
2020 Jan-Dec |
|---|---|---|---|---|---|
| Net sales | 133,436 | 82,587 | 253,544 | 135,161 | 337,004 |
| Cost of goods sold | -19,146 | -5,657 | -31,215 | -16,451 | -42,107 |
| Gross profit | 114,290 | 76,930 | 222,329 | 118,710 | 294,897 |
| Operating expenses | |||||
| Marketing and distribution costs | -58,940 | -45,231 | -108,198 | -92,708 | -186,937 |
| Administrative expenses | -6,246 | -9,911 | -16,107 | -16,320 | -97,946 |
| Research and development costs | -114,816 | -49,442 | -194,608 | -117,454 | -232,394 |
| Other operating income | 1,212 | 1,753 | 1,192 | 347 | 1,037 |
| Operating result | -64,500 | -25,901 | -95,392 | -107,425 | -221,343 |
| Interest income and similar items | 43 | 55 | 85 | 109 | 193 |
| Interest expense and similar items | -24 | -8 | -25 | -11 | -15 |
| Result after financial items | -64,481 | -25,854 | -95,332 | -107,327 | -221,165 |
| Result before tax | -64,481 | -25,854 | -95,332 | -107,327 | -221,165 |
| Tax on result for the period 9 |
13,264 | 5,086 | 19,271 | 21,564 | 43,543 |
| Result for the period | -51,217 | -20,768 | -76,061 | -85,763 | -177,622 |
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 |
30-06-2021 | 30-06-2020 | 31-12-2020 | |
|---|---|---|---|---|
| ASSETS | ||||
| Fixed assets | ||||
| Tangible assets | ||||
| Equipment | 8,615 | 9,759 | 8,661 | |
| Financial assets | ||||
| Interests in group companies | 3,403 | 2,317 | 2,577 | |
| Deferred tax assets | 9 | 332,468 | 286,716 | 313,096 |
| Total fixed assets | 344,486 | 298,792 | 324,334 | |
| Current assets | ||||
| Inventories | ||||
| Finished goods and goods for resale | 51,002 | 47,671 | 58,947 | |
| Raw material | 47,000 | 28,230 | 42,004 | |
| Total inventories | 98,002 | 75,901 | 100,951 | |
| Current receivables | ||||
| Receivables subsidiaries | 6,772 | 10,472 | 10,256 | |
| Trade receivables | 82,422 | 36,060 | 36,247 | |
| Other receivables | 7,924 | 8,780 | 32,413 | |
| Prepayments and accrued income | 9,648 | 9,414 | 8,663 | |
| Total current receivables | 106,766 | 64,726 | 87,579 | |
| Cash and bank deposit | 380,091 | 190,004 | 429,290 | |
| Total current assets | 584,859 | 330,631 | 617,820 | |
| TOTAL ASSETS | 929,345 | 629,423 | 942,154 |
| KSEK Note |
30-06-2021 | 30-06-2020 | 31-12-2020 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| EQUITY | |||
| Restricted equity | |||
| Share capital (54,538,571 shares) | 1,364 | 1,291 | 1,356 |
| Statutory reserve | 11,327 | 11,327 | 11,327 |
| Total restricted equity | 12,691 | 12,618 | 12,683 |
| Unrestricted equity | |||
| Retained earnings | -984,054 | -806,432 | -806,432 |
| Share premium reserve | 1,805,257 | 1,379,045 | 1,763,470 |
| Result for the period | -76,061 | -85,763 | -177,622 |
| Total unrestricted equity | 745,142 | 486,850 | 779,416 |
| Total equity 10 |
757,833 | 499,468 | 792,099 |
| 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 |
| Social security fees employee share | |||
| options program | 252 | – | – |
| Total long-term liabilities | 824 | 572 | 572 |
| Short-term liabilities | |||
| Trade payables | 25,419 | 29,011 | 16,628 |
| Other liabilities | 12,524 | 5,825 | 6,120 |
| Accrued expenses and deferred income | 129,259 | 91,061 | 123,249 |
| Total short-term liabilities | 167,202 | 125,897 | 145,997 |
| TOTAL EQUITY AND LIABILITIES | 929,345 | 629,423 | 942,154 |
| Key figures, MSEK | 2021 Apr-Jun |
2020 Apr-Jun |
2021 Jan-Jun |
2020 Jan-Jun |
2020 Jan-Dec |
|---|---|---|---|---|---|
| Total revenue | 138 | 81 | 264 | 130 | 336 |
| Operating expenses | -179 | -102 | -315 | -219 | -508 |
| Operating result | -60 | -23 | -86 | -100 | -205 |
| Result for the period | -48 | -20 | -70 | -82 | -167 |
| Cash flow from operating activities | -41 | -66 | -102 | -132 | -239 |
| Cash and cash equivalents | 422 | 222 | 422 | 222 | 462 |
| Equity | 820 | 550 | 820 | 550 | 847 |
| Equity ratio in group, percent | 78% | 76% | 78% | 76% | 81% |
| Total assets | 1,046 | 723 | 1,046 | 723 | 1,044 |
| Weighted average number of shares, before dilution | 54,349,123 | 51,636,858 | 54,292,362 | 51,636,858 | 52,678,479 |
| Weighted average number of shares, after dilution | 55,887,516 | 53,557,081 | 55,764,282 | 53,557,616 | 54,615,059 |
| Earnings per share before dilution, SEK | -0.89 | -0.39 | -1.29 | -1.58 | -3.18 |
| Earnings per share after dilution, SEK | -0.89 | -0.39 | -1.29 | -1.58 | -3.18 |
| Equity per share before dilution, SEK | 15.08 | 10.64 | 15.10 | 10.64 | 16.09 |
| Equity per share after dilution, SEK | 14.67 | 10.26 | 14.70 | 10.26 | 15.52 |
| Number of employees at end of period | 140 | 132 | 140 | 132 | 134 |
| Number of employees in R&D at end of period | 77 | 77 | 77 | 77 | 77 |
| R&D costs as a percentage of operating expenses | 65% | 49% | 63% | 54% | 47% |
Cash and cash equivalents Cash and cash bank balances
Equity ratio, percent Equity divided by total capital
Weighted average number of shares, before dilution Weighted average number of shares before adjustment for dilution effect of new shares
Weighted average number of shares, after dilution Weighted average number of shares adjusted for the dilution effect of new shares
Earnings per share before dilution, SEK Result divided by the weighted average number of shares outstanding before dilution Earnings per share after dilution, SEK Result divided by the weighted average number of shares outstanding after dilution
Equity per share before dilution, SEK Equity divided by the weighted average number of shares at the end of the period before dilution
Equity per share after dilution, SEK Equity divided by the weighted average number of shares at the end of the period after dilution
R&D costs as a percentage of operating expenses Research and development costs divided by operating expenses, excluding items affecting comparability (marketing and distribution costs, administrative expenses and research and development costs)
Camurus AB, corp. ID No. 556667-9105 is the parent company of the Camurus group and has its registered office based in Lund, Sweden, at Ideon Science Park, 223 70 Lund. Camurus AB group's interim report for the second quarter 2021 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 2020, see camurus.com/Investors/Financial Reports.
As of this report, IFRS 2 is applied to the employee stock option program decided on by the Annual General Meeting on May 6, 2021, see Note 2.3.
No new or revised IFRS standards, with any material impact on the group, have come into force.
Derivatives are reported in the balance sheet on the transaction day and are valued at fair value, both initially and in subsequent revaluations at the end of each reporting period. The group does not apply hedge accounting and all changes in the fair value of derivative instruments are reported directly in the income statement as Other operating income or Other operating expenses. Derivatives are reported in the balance sheet as Other receivables and Other liabilities.
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.
Derivatives with a negative fair value are reported in the balance sheet as Other liabilities and changes in the fair value of derivative instruments are reported directly in the income statement on the line Other operating income or Other operating expenses. Derivatives with a positive fair value are reported at the lower of acquisition value and fair value.
Camurus has three long-term incentive programs active for the company's employees. The programs were adopted by the Annual General Meeting (AGM) in 2018, 2019 and 2020.
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.
At the Annual General Meeting on 6 May, 2021, it was decided to implement Incentive Program 2021/2024 based on employee stock options for the company's employees. The options are granted free of charge and have a term of approximately 3
years from the grant date. Once vested, the options can be exercised during the period 1 June - 16 December, 2024 (exercise period) provided that the participant is still employed. Each vested option gives the holder the right to acquire one share in Camurus at a pre-defined price corresponding to 130 percent of the volume-weighted average price for the company's share on Nasdaq Stockholm during the ten trading days immediately following the company's AGM 2021 whereby the price was set at SEK 263.50. The incentive program comprises a maximum of 1,215,500 employee stock options.
The fair value of the service that entitles to the allotment of options through the program is reported as a personnel cost with a corresponding increase in equity. The total amount to be expensed is based on the fair value of the employee stock options granted, including the share target price, and that the employee remains in the company's service during the exercise period. The total cost is reported over the vesting period. At the end of each reporting period, the company reconsiders its assessment of how many options are expected to be exercised and the difference is reported in the income statement and a corresponding adjustment is made in equity. As a basis for allocating social security contributions, a revaluation of fair value is continuously made for the employee stock options earned at the end of each reporting period. Social security contributions are reported as personnel costs and the corresponding provision is made under long- or short-term liabilities depending on the remaining term.
In June, a total of 1,069,150 employee options were granted, of which 60,000 to the CEO, 225,000 other senior executives and 784,150 other employees.
The fair value of the option when implementing the program has been calculated using Black & Scholes' valuation model, which takes into account the exercise price, the term of the option, the share price on the allotment date and the expected volatility in the share price and risk-free interest for the option. The fair value of the employee stock option was set at SEK 61.18 in connection with the implementation of the program on 10 June, 2021.
For further information about this program, see the minutes from the 2021 Annual General Meeting published on the company's website, www.camurus.com.
Below is a summary of the total number of shares that granted subscription warrants and employee options may entitle to as of 30 June, 2021. Full exercise of allotted warrants and employee stock options as of 30 June, 2021 corresponding to a total of 2,171,368 shares would result in a dilution of shareholders with 3.98 percent. If decided, but not granted employee options, a further total of 146,350, are fully exercised, it would result in a total dilution of shareholders of 4.25 percent.
| Change in existing incentive programs | Number of shares granted instruments may entitle to |
|---|---|
| 1 January, 2021 | 1,404,599 |
| Granted instrument | |
| TO2020/2023 | 1,000 |
| 31 March, 2021 | 1,405,599 |
| Change during the seccond quarter 2021 | |
| Granted instruments | |
| Incentive Program 2021/2024 | 1,069,150 |
| Exercised instruments | |
| TO2018/2021 | -303,381 |
| Total change | 765,769 |
| Number of shares granted instruments may | 2,171,368 |
| entitle to as of 30 June, 2021 |
| Program | Number of shares subscribed warrants entitles to |
Potential dilution of the sub scribed warrants and options |
Subscription period |
Strike price SEK, for sub scription of shares upon exercise |
Market value3) | Number of employees partici pating in the program |
|---|---|---|---|---|---|---|
| TO2018/2021 | 304,1841,2) | 0.56%1,2) 15 May 2021- 15 Dec 2021 |
133.401) 14 May 2018: 12.83 SEK 20 Aug 2018: 9.94 SEK |
46 | ||
| TO2019/2022 | 597,4592) | 1.10%2) 15 May 2022- 15 Dec 2022 |
98.90 | 3 Jun 2019: 11.10 SEK | 63 | |
| TO2020/2023 | 200,5752) | 0.37%2) 15 May 2023- 15 Dec 2023 |
169.50 | 17 Aug 2020: 44.70 SEK 14 Dec 2020: 50.70 SEK 10 Mar 2021: 75.50 SEK |
40 | |
| TO2021/2024 | 1,069,150 | 1.96% | 1 Jun 2024- 16 Dec 2024 |
263.50 | 10 Jun 2021: 61.18 SEK | 129 |
| Total | 2,171,368 | 3.98% |
1) After recalculation of the warrants in TO2018/2021 (after exercise in May 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 2,146,251, corresponding to a dilution effect of 3.94 percent.
2) No further allocation can be made.
3) Market valuation 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. There is also a risk that differences of opinion will arise between Camurus and its partners or that such partners do not meet their contructual commitments.
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, NOK, SEK and USD. As of 30 June, 2021, Camurus has managed part of the risk with currency derivatives forward contracts.
The group reports a deferred tax asset of MSEK 324.9 as of 30 June, 2021. 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. The company sees the European Commission and Australian TGA's approvals of Buvidal® for treatment of opioid dependence in November 2018 and the launch and ongoing sale of Buvidal in EU and Australia as further validation of FluidCrystal injection depot, and are events that confirm the likelihood assessments made by the company when determening the amount of the deferred tax asset. The fact that the company's partner Braeburn received a Complete Response Letter from the FDA for Brixadi™ in December 2020, does not change the assessment. During the quarter, Braeburn submitted the updated NDA application and FDA announced that PDUFA action date is set to 15 December, 2021.
Future revenues will mainly be generated from Camurus' own sales organization in markets where Camurus have own commercialization capabilities, and through partnerships for markets where Camurus has outlicensed 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 2020 (The Director's Report).
The Board of Directors has not changed its outlook on future developments in relations to their outlook published in the interim report for the first quarter 2021.
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 |
2021 Apr-Jun |
2020 Apr-Jun |
2021 Jan-Jun |
2020 Jan-Jun |
2020 Jan-Dec |
|---|---|---|---|---|---|
| Sales of development related | |||||
| goods and services | 1,296 | 5,117 | 2,896 | 5,736 | 9,036 |
| Licensing revenues and | |||||
| milestone payment | – | – | – | 63 | 4,428 |
| Product sale1) | 136,599 | 75,755 | 260,896 | 124,369 | 322,533 |
| Total | 137,895 | 80,872 | 263,792 | 130,168 | 335,997 |
| Revenues allocated by geographical area |
2021 Apr-Jun |
2020 Apr-Jun |
2021 Jan-Jun |
2020 Jan-Jun |
2020 Jan-Dec |
| Europe | 83,199 | 50,279 | 160,503 | 82,246 | 205,768 |
| (whereof Sweden) | (9,537) | (2,828) | (16,885) | (5,227) | (14,389) |
| North America | 647 | 5,043 | 1,290 | 5,721 | 13,224 |
| Asia including Oceania | 54,049 | 25,550 | 101,999 | 42,201 | 117,005 |
| Total | 137,895 | 80,872 | 263,792 | 130,168 | 335,997 |
Revenues during the quarter of approximately MSEK 50.2 (23.0) relate to one single external customer.
99.8 (99.8) 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 and options. For this category, 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 and options. The number of shares calculated as above are compared to the number of shares that would have been issued assuming the warrants and options are exercised.
| KSEK | 2021 Apr-Jun |
2020 Apr-Jun |
2021 Jan-Jun |
2020 Jan-Jun |
2020 Jan-Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders Weighted average number |
-48,389 | -19,960 | -70,263 | -81,512 | -167,265 |
| of ordinary shares outstanding (thousands) |
54,349 | 51,637 | 54,292 | 51,637 | 52,678 |
| KSEK | 2021 Apr-Jun |
2020 Apr-Jun |
2021 Jan-Jun |
2020 Jan-Jun |
2020 Jan-Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders |
-48,389 | -19,960 | -70,263 | -81,512 | -167,265 |
| Weighted average number of ordinary shares |
|||||
| outstanding (thousands) | 54,349 | 51,637 | 54,292 | 51,637 | 52,678 |
| Adjustment for warrants | |||||
| and options (thousands) | 1,538 | 1,920 | 1,472 | 1,921 | 1,937 |
| Weighted average number of | 55,888 | 53,557 | 55,764 | 53,558 | 54,615 |
| ordinary shares used in | |||||
| calculation of earnings per | |||||
| share after dilution (thousands) |
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.
Financial assets and liabilities in the group that are reported at fair value consist of derivatives (currency futures). All derivatives are included in level 2 when valuing at fair value, which means that fair value is determined using valuation techniques that are based on market information as much as possible, while company-specific information is used as little as possible. All significant input data required for the fair value measurement of an instrument is observable. The fair value of forward exchange contracts is determined as the present value of future cash flows based on exchange rates for forward exchange contracts on the balance sheet date.
| Balance sheet assets, KSEK | 30-06-2021 | 30-06-2020 | 31-12-2020 |
|---|---|---|---|
| Trade receivables | 101,974 | 46,438 | 52,191 |
| Payment not yet received regarding | |||
| exercise of warrants | – | – | 27,427 |
| Derivatives - currency futures | |||
| (part of Other receivables) | 1,257 | – | – |
| Cash and cash equivalents | 421,894 | 222,004 | 461,793 |
| Total | 525,125 | 268,442 | 541,411 |
| Balance sheet liabilities, KSEK | 30-06-2021 | 30-06-2020 | 31-12-2020 |
| Trade payables | 31,603 | 31,366 | 20,712 |
| Other liabilities | 190 | 190 | 190 |
| Total | 31,793 | 31,556 | 20,902 |
There were no related party transactions outside of the Camurus group during the period.
No receivables or liabilities existed as of 30 June, 2021.
2021 Apr-Jun
2020 Apr-Jun
Depreciation 3,036 2,585 6,031 5,054 11,551 Employee options 1,588 – 1,588 – – Total 4,624 2,585 7,619 5,054 11,551
2021 Jan-Jun
2020 Jan-Jun
2020 Jan-Dec
Adjustment for non-cash items:
KSEK
| Note 9 | Tax |
|---|---|
| -------- | ----- |
Tax income for the quarter amounted to MSEK 11.7 (3.7), primary attributable to the negative result.
The change in equity for the quarter is mainly attributable to the loss during the period and the subscription of new shares through the warrant program TO2018/2021.
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and to the Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 07.00 AM (CET) on 15 July, 2021.

Camurus AB | Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 | F +46 46 286 57 39 | [email protected] | camurus.com
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