Earnings Release • Nov 10, 2022
Earnings Release
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INTERIM REPORT FOR THE THIRD QUARTER 2022
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.
• Recruitment completed in Phase 3 randomized control efficacy study of CAM2029 in acromegaly
• Operating result guidance raised from SEK -20 to 40 million to SEK 40 to 70 million2
1) At constant exchange rates, January 2022.
2) Excluding milestone payments related to a potential approval of Brixadi™ in the US.
| MSEK | 2022 Jul-Sep |
2021 Jul-Sep |
∆ | 2022 Jan-Sep |
2021 Jan-Sep |
∆ | 2021 Jan-Dec |
|---|---|---|---|---|---|---|---|
| Total revenues | 241 | 154 | 57% | 688 | 418 | 65% | 601 |
| whereof product sales | 241 | 152 | 58% | 668 | 413 | 62% | 594 |
| OPEX | 184 | 139 | 32% | 560 | 454 | 23% | 628 |
| Operating result | 41 | -6 | 48 | 53 | -92 | 146 | -111 |
| Result for the period | 35 | -6 | 41 | 42 | -76 | 119 | -90 |
| Result per share after dilution, SEK | 0.61 | -0.11 | 0.72 | 0.74 | -1.41 | 2.13 | -1.66 |
| Cash position | 520 | 426 | 22% | 520 | 426 | 22% | 412 |
Third quarter 2022
+57%
Product sales SEK 241 million +58%
Operating result SEK 41 million +SEK 48 million
Financial analysts, investors and media are invited to attend a telephone conference and presentation of the results on 10 November 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/43985
Camurus on-track to sustainable profitability
In the third quarter 2022, we continued the path to sustainable profitability through growing Buvidal® sales and an increased positive operating result, which further consolidated our financial position. We continued the market expansion through new Buvidal regulatory and pricing approvals and advanced our registration and Phase 3 programs in chronic pain and rare diseases. The development programs were presented at our Capital Markets and R&D Day in September along with a five-year vision for growth and innovation.
The third quarter was financially Camurus' best quarter to date with growing net revenues and a positive operating result of SEK 41 million. Year to date the operating result was SEK 53 million compared to SEK -92 million last year, an increase of SEK 146 million. Our cash position increased by SEK 93 million over the quarter to SEK 520 million. As a result of the continued positive result in the quarter, we have raised the 2022 Full Year guidance by 45 million at the midpoint of the interval to between SEK 40 and 70 million in operating result.
Third quarter sales of Buvidal weekly and monthly depots grew at a rate of 58 percent compared to last year, and 7 percent versus previous quarter. We saw an expected slow-down during the European vacation period in July and August with
fewer initiations of new patients, followed by an accelerated uptake in September. The total estimated number of patients in treatment with Buvidal increased to above 32,000 in the quarter and the sales of Buvidal passed one million units since launch. This milestone reflects our development and commerical successes with Buvidal, and is an important validation of our FluidCrystal® technology, used in several in-house and partner development programs.
During the quarter, Buvidal market penetration continued with notable growth in the larger markets including the Nordics, Germany, and the UK. In England, we started to see positive effects of the Government's investment in opioid dependence treatment, and that new fundings started to reach the treatment clinics. In Australia we continued to build our leadership within the long-acting segment and Buvidal reached an estimated market share of over 20 percent of all patients in opioid dependence treatment. To further strengthen the access to
"Sales of Buvidal passed one million units since launch"
treatment with Buvidal, new measures are being explored to enhance patient pathways and allow for easier transfers between specialist and general practice settings.
Our market expansion efforts continued during the quarter. In Belgium the scope of reimbursement was expanded through a new approval, and Buvidal is since 1 October available across treatment settings. Buvidal received regulatory and price approvals in key MENA countries, Egypt and Saudi Arabia, after priority reviews. Buvidal is the first approved maintenance treatment of opioid dependence in these countries and launches are expected during the fourth quarter. Furthermore, five applications are currently being evaluated in other MENA countries with outcomes expected in 2023.
In the US, we were recently informed by our licensee Braeburn that inspections of their third-party manufacturer by the US Food and Drug Administration (FDA) are expected to be formally completed soon. We are currently waiting for Braeburn to provide details about the inspection outcomes and their anticipated resubmission timing to the FDA of the new drug application (NDA) for BrixadiTM. The review period after NDA submission is nominally two months if the agency decides on a Class 1 review, or six months if the agency decides on a Class 2 review.
In addition to geographic expansion, reviews of our applications in the EU and Australia for extending the Buvidal indication to include chronic pain continued to progress. An opinion by the EMA's Committee for Medicinal Products for Human Use, CHMP, is expected in the fourth quarter or in the first quarter 2023. A review process by the Australian Therapeutic Goods Administration is progressing in parallel with an approval decision expected in the first half of 2023.
Our acromegaly Phase 3 ACROINNOVA program for CAM2029, octreotide subcutaneous depot, continued to progress. Patient recruitment has been completed in the first Phase 3 study of CAM2029 and results are expected mid-2023. We are grateful to all investigators, clinical staff, and participating patients for their critical contributions to this milestone. The covid pandemic and the war in Ukraine have been significant recruitment challenges and I am pleased to note that we are on track to complete this important study in the first half of 2023. Furthermore, we reached the enrollment target of new patients in the Phase 3 long-term safety study, in addition to roll-over patients from the randomized study. In response to physician and patient requests, the long-term safety study is being extended to allow treatment and assessment of patients for a further 12-month period. Submission of the first regulatory application for CAM2029 for the treatment of acromegaly is planned around year-end 2023/24.
CAM2029 is also under development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NET). Patient recruitment has continued and reached 25 percent of target 302 patients in the SORENTO Phase 3 study, which main objective is to assess the superiority in progression free survival of CAM2029 versus standard of care. The SORENTO study was recently the topic of a satellite symposium at the North American Neuroendocrine Tumor Society in Washington DC, 27-29 October 2022.
Finally, in our third clinical program with CAM2029, the first patient was dosed in the POSITANO Phase 2b study of CAM2029 for the treatment of polycystic liver disease (PLD). PLD is a serious and burdensome disease with currently no approved treatments and thus therefore is a high unmet medical need. Growing scientific evidence shows, that somatostatin analogues like octreotide, may be effective in treating PLD.1,2 The objective of the POSITANO study is to assess the efficacy of CAM2029 in reducing and controlling the liver size as well as improving disease symptoms in PLD patients.
"Patient recruitment has been completed in the first Phase 3 study of CAM2029 and results are expected mid-2023"
In the third quarter, we completed the clinical study report for the Phase 2a study of weekly subcutaneous treprostinil in patients with Raynaud's Phenomenon secondary to systemic sclerosis (scleroderma). The study did not meet the primary endpoint at 6 hours but met important secondary endpoints, including a clinically and statistically significant treatment difference in patient reported Raynaud's Condition Score up to 15 days post CAM2043 dosing. A publication of the results from the study is being prepared.
Based on the completed Phase 2a study results, discussions with clinical experts, and market research update, we are planning for further clinical study to assess CAM2043 in 2023. Currently, there is a lack of effective treatments for secondary Raynaud's phenomenon, and CAM2043, if approved, could fill an important unmet medical need for patients with systemic sclerosis and Raynaud's phenomenon.
Adding to the progress of our own programs, our partner Rhythm Pharmaceuticals continued their Phase 3 switch study of weekly subcutaneous setmelanotide depot in patients with Bardet-Biedl Syndrome (BBS) and other rare genetic diseases of obesity. Results are expected in 2023 along with the start of a new phase 3 study in new to treatment patients.
I am pleased with the performance and significant progress Camurus has made during the period with growing revenues and positive operating result for the third consecutive quarter, while making significant investments in our late-stage pipeline of rare disease treatments, including two Phase 3 programs. We are expecting to comfortably reach profitability for the full year and have raised our guidance for operating result.
At our Capital Markets and R&D Day we launched our fiveyear vision for growth and innovation. The vision includes a
five-times growth of topline revenues and reaching an operating margin of around 50 percent by 2027. This will be driven by market penetration and expansion in the opioid dependence area and by diversifying our product portfolio through lifecycle management, new product approvals and commercial launches. In addition, we will actively pursue inorganic growth opportunities that are synergistic to our business and can be value adding in the near or mid-term perspective. Thanks to all participants for making this such a successful event, with a special thanks to our external guest speakers.
To meet the requirements of our growing business, we have continued to build our organization, adding new and promoting in-house talents in our company. Markus Johnsson, previously holding the position as responsible for portfolio and project management, was appointed SVP R&D and member of our Executive Team.
Finally, after two years of Covid restrictions and lockdowns, all employees were able to meet face to face in Helsingborg, Sweden, get familiarized and energized, share successes and challenges, and align on the values, strategy, and vision of the company.
To sum up, we had a good third quarter and are committed to continue creating sustainable value to our stakeholders by developing new effective medications and making these accessible to patients with severe and chronic diseases.
Thank you for your interest and continued support.
Fredrik Tiberg, President and Chief Executive Officer
"Positive operating result for the third consecutive quarter"
1. Gevers TJ, et al. Curr Opin Gastroenterol. 2011;27:294–300. 2. Garofalo C., et al. Sci Rep. 2021 Dec 6;11(1):23500.
Camurus has a broad and diversified product and pipeline portfolio of innovative medicines from early-stage 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 cost, 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 areas i) central nervous system (CNS), ii) rare diseases and iii) oncology and supportive care.
Buvidal (buprenorphine) prolonged-release solution for injection is used for the treatment of opioid dependence within a framework of medical, social and psychological treatment, in adults and adolescents aged 16 years and over.1 Buvidal is available as weekly and monthly formulations in multiple dose options, offering the flexibility to tailor treatment to individual patient needs. Buvidal provides fast onset and a long-acting release of buprenorphine, resulting in effective reduction of illicit opioid use, withdrawal and craving over the weekly or monthly dosing periods. Buvidal has been demonstrated to block effects of other opioids and thereby has the potential to reduce the risk of relapse and overdose.2 Clinical studies and realworld experience have demonstrated superiority in reduction of illicit opioid use and treatment satisfaction outcomes, reduced treatment burden, and improved quality of life for patients with Buvidal compared to standard treatment with daily sublingual buprenorphine.3-5
– In England, new funding started to become available through the Government's initiative to create a world-class treatment system
In addition to the approved indication for treatment of opioid dependence, CAM2038 is being developed for the treatment of chronic pain. Applications for regulatory approval of CAM2038 in chronic pain are currently under review by the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA). There is a high unmet medical need in chronic pain, particularly among patients who have or who are at risk of developing dependency on opioids. If approved, Buvidal could become an important therapeutic option for the management of chronic pain, adding to the current indication of treatment of opioid dependence.
CAM2029 is a novel subcutaneous octreotide depot under development for the treatment of three rare diseases: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD). Studies completed to date demonstrate that CAM2029 provides significantly higher octreotide bioavailability and enhanced octreotide exposure, with the potential for improved efficacy, compared to current standard treatments.6 In addition, CAM2029 is designed to enable convenient self-administration in a home-setting, using a pre-filled syringe with safety device or state-of-the-art pre-filled pen. Current acromegaly and GEP-NET treatments with first-generation somatostatin analogues require complex handling in several steps, including reconstitution and/or conditioning, and intramuscular or deep subcutaneous administration by a trained healthcare professional.7,8
• Patient recruitment countined in the ongoing SORENTO (Subcutaneous Octreotide Randomized Efficacy in Neuroendocrine TumOrs) Phase 3 study. More than 25 percent of the total planned number of patients in the study have now been randomized and dosed.11
• Dosing initiated in Phase 2b study POSITANO (POlycystic liver Safety and effIcacy TriAl with subcutaNeous Octreotide)12
CAM2043 is a long-acting subcutaneous treprostinil formulation developed as a patient-friendly and effective treatment option for people with pulmonary arterial hypertension and Raynaud's phenomenon, secondary to systemic sclerosis.
CAM4072 is a weekly formulation of the MC-4 agonist setmelanotide, developed by Camurus' partner Rhythm Pharmaceuticals for the treatment of a range of rare genetic disorders of obesity. The product candidate is based on Camurus' FluidCrystal injection depot and is being developed to offer patients a simpler and more convenient dosing regimen with the possibility of improved treatment adherence.
episil is a medical device product based on Camurus' FluidCrystal topical bioadhesive technology. episil oral liquid is used for the treatment of inflammatory and painful conditions in the oral cavity, such as oral mucositis - 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.
Third quarter 2022 solidified the company's path to sustainable profitable growth, delivering 35 MSEK profit after taxes in the quarter and 42 MSEK Year To Date. Cashflow was positive with our cash position reaching 520 MSEK, driven by profitable operations, a second window of Camurus' TO 2019/2022 program and partial payment for Solasia's acquisition of episil.
Camurus will continue investing in R&D to take new innovative medicinal products for the treatment of patients with severe and chronic CNS conditions and rare diseases to the market. The investments in CAM2029 and other late-stage product candidates may vary over time and thereby impact profitability over the next few quarters.
During the period Camurus continued to strengthen the company's sustainability work:
Mapping of sustainability aspects for Camurus manufacturing suppliers finalized and sustainability mapping ongoing of transports and wholesalers
For the fifth year in a row, Camurus supported the organizers of the International Overdose Awareness Day (IOAD) which took place on 31 August. The global campaign aims to raise awareness around overdose, reduce stigma and convey the message that overdose deaths incidences can be prevented and treated.
For more information about Camurus' sustainability work see: www.camurus.com.
• Markus Johnsson, previously Senior Director for Camurus' Project and Portfolio management, was appointed Senior VP R&D and new member of the Executive Management Team
Total revenues during the quarter amounted to MSEK 241.4 (154.0), an increase by 57 percent (45 percent at CER1 ).
Product sales were MSEK 240.5 (152.0), corresponding to an increase of 58 percent (47 percent at CER) compared to the third quarter 2021 and 7 percent increase versus prior quarter.
During January-September period, total revenues were MSEK 688.3 (417.8), up 65 percent compared to the same period 2021. Product sales were MSEK 667.8 (412.9), up 62 percent.
For further information, see Note 4.
Marketing and distribution costs were MSEK 67.0 (50.6) in the quarter, and for January-September period MSEK 195.3 (150.5), an increase driven by commercial acceleration of Buvidal® in Europe and Australia as well as expansion to new markets.
Administrative expenses for the quarter were MSEK 10.5 (5.3) and for the first nince months MSEK 26.0 (21.3), aligned with Corporate evolution to substantiate company development. Global company meeting was held in September.
R&D costs, including depreciation and amortization of tangible and intangible assets, were MSEK 106.6 (83.5) for the quarter and MSEK 338.7 (282.4) year to date. The increase compared to previous year and quarter is mainly linked to the continued progress in the three ongoing pivotal Phase 3 programs of CAM2029 for the treatment of acromegaly, neuroendochrine tumors and polycystic liver disease.
The operating result for the quarter was MSEK 41.4 (-6.3) while the operating result in the first nine months was MSEK 53.1 (-92.4).
1) At constant exchange rates in January 2022.
Financial items in the period were MSEK 0.1 (-0.3) and MSEK -0.4 (-0.9) for the first nine months of the year.
Tax in the quarter was MSEK -6.5 (0.5) while MSEK -10.1 (16.9) for the period January-September 2022 driven by company development to profitability status. Additionally, episil® divestiture in July 2022 provided a taxable profit of MSEK 6.5.
The result for the period amounted to MSEK 35.0 (-6.2) and MSEK 42.5 (-76.4) year to date.
Earnings per share before dilution were SEK 0.63 (-0.11) for the period and for the nine months SEK 0.77 (-1.41). Earnings per share after dilution were SEK 0.61 (-0.11) for the period and for the January-September period SEK 0.74 (-1.41).
Cash flow from operating activities, before change in working capital, amounted to MSEK 54.8 (-0.5) for the quarter and year to date MSEK 87.3 (-80.5). The difference compared to previous year is driven by operating result improvement, episil divestiture (see Note 11) and adjustments for non cash items (depreciation, derivatives and employee options as shown in Note 8).
The change in working capital affected the cash flow by MSEK -0.8 (-3.2) in the quarter and during January-September by MSEK -31.2 (-25.2).
Cash flow from investing activities in the quarter was MSEK 7.1 (-0.4) and MSEK 5.7 (-2.1) year to date driven by episil acquisition by Solasia (see Note 11).
Cash flow from financing activities was MSEK 28.6 (7.0) in the quarter and relates to payments for the exercise of warrants in TO2019/2022. Year to date, the cash flow was MSEK 42.5 (72.3).
The cash position for the group as of 30 September, 2022 was MSEK 519.5 (426.5).
There were no loans as of 30 September, 2022 and no loans have been taken since this date.
Consolidated equity as of 30 September, 2022 was MSEK 968.4 (827.5). The dif ference compared to last year mainly relates to the year to date result for 2022 and the exercise of warrants in the warrant program TO2018/2021 during the last quarter 2021 and TO2019/2022 during 2022.
Total assets for the group were MSEK 1,233.6 (1,046.0).
The company's total revenue in the quarter amounted to MSEK 222.4 (145.9) and year to date MSEK 654.0 (399.5). The result after tax in quarter was MSEK 30.1 (-9.1) and for January-September MSEK 31.0 (-85.2).
On 30 September, 2022, equity in the parent company amounted to MSEK 883.8 (762.6) and total assets to MSEK 1,076.1 (926.5), of which MSEK 426.0 (372.7) were cash and cash equivalents.
On 8 July, 2022, Camurus announced the acquisition of its medical device product episil for treatment of oral pain due to oral mucositis by current partner Solasia Pharma K.K. in Japan. Camurus will receive a consideration of MEUR 1.8 plus a 20 percent royalty up to a maximum of MEUR 1.3 in exchange of the episil asset transfer.
Camurus' share is listed on Nasdaq Stockholm.
At the end of the period, the total number of shares and votes was 55,383,447 (54,602,227). The difference compared to last year mainly relates to new shares through the exercise of warrants in TO2018/2021 and TO2019/2022 programs.
Currently, Camurus has four long-term share-based incentive programs ongoing for the company's employees, two subscription warrant programs, and two employee option programs. During the quarter and January-September respectively, earnings after tax were negatively impacted by MSEK 0.0 and MSEK 1.1 related to the stay-on bonus the participants receive as part of the subscription warrant programs. Corresponding impact, without any cash flow effect, for the employee option programs was MSEK 10.8 after tax during the quarter and MSEK 21.6 year to date.
For further information about the programs, see Note 2.3.
At the end of the period, Camurus had 170 (146) employees, of whom 93 (83) were within research and development and medical affairs, 62 (48) within business development and marketing and sales, and 14 (14) within administration. The number of employees, in terms of full-time equivalents, amounted to 157 (132) during the quarter and 149 (129) during the first nine months.
Camurus full year 2022 guidance updated in Q3 interim report:
1The outlook excludes milestone payments related to a potential approval of Brixadi™ in the US. 2Based on exchange rates in January 2022.
Camurus Annual General Meeting will be held on Wednesday 10 May 2023, at 5 pm CET, at Elite Hotel Ideon, Scheelevägen 27, 223 63 Lund, Sweden.
This report has been reviewed in summary 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.
| Presentation Q3 2022 | 10 November, 2022, at 2 pm CET |
|---|---|
| Full Year Report 2022 | 14 February, 2023 |
| Annual Report 2022 | 30 March, 2023 |
| Q1 Interim Report 2023 | 10 May, 2023 |
| AGM 2023 | 10 May, 2023, at 5 pm CET |
| Q2 Interim Report 2023 | 18 July, 2023 |
| Q3 Interim Report 2023 | 9 November, 2023 |
For further information, please contact: Fredrik Tiberg, President and CEO Tel. +46 46 286 46 92, e-mail: [email protected]
Lund, Sweden, 10 November, 2022 Camurus AB Board of Directors
We have reviewed the condensed interim financial information (interim report) of Camurus AB as of 30 September 2022 and the nine-month period then ended. The board of directors and the CEO are responsible for the preparation and presentation of the interim financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
We conducted our review in accordance with the International Standard on Review Engagements ISRE 2410, Review of Interim Report Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing, ISA, and other generally accepted auditing standards in Sweden. The procedures performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act, regarding the group, and with the Swedish Annual Accounts Act, regarding the parent company.
Stockholm, 10 November 2022
PricewaterhouseCoopers AB
Lisa Albertsson Authorized Public Accountant Auditor in charge
| KSEK Note |
2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Jan-Dec |
|---|---|---|---|---|---|
| Total revenue 4 |
241,362 | 153,984 | 688,325 | 417,776 | 600,570 |
| Cost of goods sold | -24,027 | -20,927 | -75,273 | -57,191 | -85,352 |
| Gross profit | 217,335 | 133,057 | 613,052 | 360,585 | 515,218 |
| Marketing and distribution costs | -67,035 | -50,557 | -195,328 | -150,544 | -212,248 |
| Administrative expenses | -10,468 | -5,296 | -26,013 | -21,310 | -27,563 |
| Research and development costs | -106,565 | -83,452 | -338,676 | -282,400 | -388,688 |
| Other operating income 11 |
8,104 | 214 | 7,029 | 1,245 | 2,707 |
| Other operating expenses | – | -271 | -6,987 | – | – |
| Operating result | 41,371 | -6,305 | 53,077 | -92,424 | -110,574 |
| Finance income | 472 | 43 | 567 | 128 | 171 |
| Finance expenses | -331 | -367 | -1,012 | -1,029 | -1,365 |
| Net financial items | 141 | -324 | -445 | -901 | -1,194 |
| Result before tax | 41,512 | -6,629 | 52,632 | -93,325 | -111,768 |
| Income tax 9 |
-6,513 | 462 | -10,146 | 16,895 | 21,322 |
| Result for the period1) 5 |
34,999 | -6,167 | 42,486 | -76,430 | -90,446 |
| Other comprehensive income | |||||
| Exchange-rate differences | 1,060 | 95 | 3,423 | 800 | 1,587 |
| Comprehensive income for the period | 36,059 | -6,072 | 45,909 | -75,630 | -88,859 |
1) All attributable to parent company shareholders.
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan-Dec | |
| Earnings per share before dilution, SEK | 0.63 | -0.11 | 0.77 | -1.41 | -1.66 |
| Earnings per share after dilution, SEK | 0.61 | -0.11 | 0.74 | -1.41 | -1.66 |
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 16 Camurus' share, and Note 2.3.
| KSEK | Note | 30-09-2022 | 30-09-2021 | 31-12-2021 |
|---|---|---|---|---|
| ASSETS Fixed assets |
||||
| Intangible assets | ||||
| Capitalized development expenditure | 24,043 | 33,859 | 33,713 | |
| Tangible assets | ||||
| Lease assets | 24,749 | 25,468 | 24,847 | |
| Equipment | 9,585 | 8,620 | 9,882 | |
| Financial assets | ||||
| Deferred tax receivables | 9 | 328,709 | 327,149 | 334,153 |
| Other long-term receivables | 11 | 6,983 | – | – |
| Total fixed assets | 394,069 | 395,096 | 402,595 | |
| Current assets | ||||
| Inventories | ||||
| Finished goods and goods for resale | 85,384 | 55,396 | 53,121 | |
| Raw material | 32,009 | 49,197 | 54,081 | |
| Total inventories | 117,393 | 104,593 | 107,202 | |
| Current receivables Trade receivables |
169,338 | 94,947 | 135,994 | |
| Other receivables | 19,073 | 17,361 | 17,887 | |
| Prepayments and accrued income | 11 | 14,141 | 7,533 | 6,644 |
| Total current receivables | 6 | 202,552 | 119,841 | 160,525 |
| Cash and cash equivalents | 519,541 | 426,477 | 411,575 | |
| Total current assets | 839,486 | 650,911 | 679,302 | |
| TOTAL ASSETS | 1,233,555 | 1,046,007 | 1,081,897 |
| KSEK Note |
30-09-2022 | 30-09-2021 | 31-12-2021 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| EQUITY | |||
| Equity attributable to | |||
| parent company shareholders | |||
| Share capital | 1,385 | 1,365 | 1,371 |
| Other contributed capital | 1,961,010 | 1,852,732 | 1,887,395 |
| Retained earnings, including | |||
| comprehensive income for the period | -993,949 | -1,026,629 | -1,039,858 |
| Total equity 10 |
968,446 | 827,468 | 848,908 |
| LIABILITIES | |||
| Long-term liabilities | |||
| Lease liabilities | 17,360 | 19,892 | 18,925 |
| Social security costs for employee options | 9,802 | 942 | 1,019 |
| Total long-term liabilities | 27,162 | 20,834 | 19,944 |
| Short-term liabilities | |||
| Trade payables | 46,467 | 31,598 | 52,857 |
| Lease liabilities | 7,772 | 6,556 | 6,731 |
| Income taxes | 5,883 | 6,258 | 6,936 |
| Other liabilities | 39,714 | 16,252 | 20,960 |
| Accrued expenses and deferred income | 138,111 | 137,041 | 125,561 |
| Total short-term liabilities 6 |
237,947 | 197,705 | 213,045 |
| TOTAL EQUITY AND LIABILITIES | 1,233,555 | 1,046,007 | 1,081,897 |
| Share | Other contri buted |
Retained earnings, incl. compr. income for |
Total | ||
|---|---|---|---|---|---|
| KSEK | Note | capital | capital | the period | equity |
| Opening balance 1 January, 2021 | 1,356 | 1,797,084 | -950,999 | 847,441 | |
| Comprehensive income for the period | – | – | -75,630 | -75,630 | |
| Transactions with shareholders | |||||
| Exercise of warrants | 9 | 49,171 | – | 49,180 | |
| Employee stock options program | – | 6,794 | – | 6,794 | |
| Issuance costs, net after deferred tax | – | -560 | – | -560 | |
| Warrants issued | – | 243 | – | 243 | |
| Closing balance 30 September, 2021 | 1,365 | 1,852,732 | -1,026,629 | 827,468 | |
| Opening balance 1 January, 2021 | 1,356 | 1,797,084 | -950,999 | 847,441 | |
| Comprehensive income for the period | – | – | -88,859 | -88,859 | |
| Transactions with shareholders | |||||
| Exercise of warrants | 15 | 79,361 | – | 79,376 | |
| Employee stock options program | – | 11,504 | – | 11,504 | |
| Issuance costs, net after deferred tax | – | -797 | – | -797 | |
| Warrants issued | – | 243 | – | 243 | |
| Closing balance 31 December, 2021 | 1,371 | 1,887,395 | -1,039,858 | 848,908 | |
| Opening balance 1 January, 2022 | 1,371 | 1,887,395 | -1,039,858 | 848,908 | |
| Comprehensive income for the period | – | – | 45,909 | 45,909 | |
| Transactions with shareholders | |||||
| Exercise of warrants | 14 | 54,862 | – | 54,876 | |
| Employee stock options program | – | 18,805 | – | 18,805 | |
| Issuance costs, net after deferred tax | – | -51 | – | -51 | |
| Closing balance 30 September, 2022 | 10 | 1,385 | 1,961,010 | -993,949 | 968,446 |
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| KSEK Note |
Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan-Dec |
| Operating activities | |||||
| Operating profit/loss before financial items | 41,371 | -6,305 | 53,077 | -92,424 | -110,574 |
| Adjustments for non-cash items 8 |
13,452 | 9,530 | 40,957 | 17,149 | 25,204 |
| Interest received | 472 | 43 | 567 | 128 | 171 |
| Interest paid | -331 | -367 | -1,012 | -1,029 | -1,365 |
| Income taxes paid | -153 | -3,391 | -6,265 | -4,295 | -3,540 |
| Cashflow from operating activities before change | 54,811 | -490 | 87,324 | -80,471 | -90,104 |
| in working capital | |||||
| Increase/decrease in inventories | 5,508 | 1,287 | -9,216 | 6,756 | 4,147 |
| Increase/decrease in trade receivables | -17,150 | 7,027 | -30,372 | -42,756 | -83,803 |
| Increase/decrease in other current receivables | -1,019 | 100 | -7,362 | -9,168 | -8,805 |
| Increase/decrease in trade payables | 6,235 | -5 | -6,729 | 10,886 | 32,145 |
| Increase/decrease in other current operating liabilities | 5,619 | -11,637 | 22,450 | 9,087 | 2,993 |
| Cash flow from changes in working capital | -807 | -3,228 | -31,229 | -25,195 | -53,323 |
| Cash flow from operating activities | 54,004 | -3,718 | 56,095 | -105,666 | -143,427 |
| Investing activities | |||||
| Acquisition/divestiture of intangible assets 11 |
7,287 | 164 | 7,287 | -132 | -952 |
| Acquisition of tangible assets | -172 | -600 | -1,604 | -1,918 | -3,991 |
| Cash flow from investing activities | 7,115 | -436 | 5,683 | -2,050 | -4,943 |
| Financing activities | |||||
| Amortization of lease liabilities | -1,953 | -1,290 | -5,309 | -3,841 | -7,142 |
| Share issue after issuance cost | 36,829 | 8,288 | 54,811 | 75,905 | 105,803 |
| Warrants issued | – | – | – | 243 | 243 |
| Other long-term receivables 11 |
-6,248 | – | -6,987 | – | – |
| Cash flow from financing activities | 28,628 | 6,998 | 42,515 | 72,307 | 98,904 |
| Net cash flow for the period | 89,747 | 2,844 | 104,293 | -35,409 | -49,466 |
| Cash and cash equivalents at beginning of the period | 428,132 | 421,894 | 411,575 | 461,793 | 461,793 |
| Translation difference in cash flow and liquid assets | 1,662 | 1,739 | 3,673 | 93 | -752 |
| Cash and cash equivalents at end of the period | 519,541 | 426,477 | 519,541 | 426,477 | 411,575 |
| KSEK Note |
2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Jan-Dec |
|---|---|---|---|---|---|
| Net sales | 222,397 | 145,908 | 654,048 | 399,452 | 571,464 |
| Cost of goods sold | -21,811 | -19,646 | -78,845 | -50,861 | -76,058 |
| Gross profit | 200,586 | 126,262 | 575,203 | 348,591 | 495,406 |
| Marketing and distribution costs | -61,697 | -50,626 | -181,488 | -158,824 | -219,635 |
| Administrative expenses | -10,648 | -5,382 | -26,297 | -21,489 | -27,853 |
| Research and development costs | -105,742 | -81,196 | -334,813 | -275,804 | -380,390 |
| Other operating income 11 |
15,326 | – | 13,756 | 1,077 | 2,015 |
| Other operating expenses | – | -115 | -6,927 | – | – |
| Operating result | 37,825 | -11,057 | 39,434 | -106,449 | -130,457 |
| Interest income and similar items | 460 | 43 | 555 | 128 | 171 |
| Interest expense and similar items | -2 | -4 | -33 | -29 | -46 |
| Result after financial items | 38,283 | -11,018 | 39,956 | -106,350 | -130,332 |
| Result before tax | 38,283 | -11,018 | 39,956 | -106,350 | -130,332 |
| Tax on result for the period | -8,184 | 1,885 | -8,960 | 21,156 | 27,079 |
| Result for the period | 30,099 | -9,133 | 30,996 | -85,194 | -103,253 |
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 | 30-09-2022 | 30-09-2021 | 31-12-2021 |
|---|---|---|---|---|
| ASSETS | ||||
| Fixed assets | ||||
| Tangible assets | ||||
| Equipment | 9,483 | 8,504 | 9,766 | |
| Financial assets | ||||
| Interests in group companies | 11,762 | 5,471 | 6,759 | |
| Deferred tax assets | 331,433 | 334,395 | 340,380 | |
| Other financial assets | 11 | 6,991 | – | – |
| Total fixed assets | 359,669 | 348,370 | 356,905 | |
| Current assets | ||||
| Inventories | ||||
| Finished goods and goods for resale | 69,412 | 47,293 | 46,443 | |
| Raw material | 32,009 | 49,197 | 54,081 | |
| Total inventories | 101,421 | 96,490 | 100,524 | |
| Current receivables | ||||
| Receivables subsidiaries | 29,458 | 19,086 | 9,288 | |
| Trade receivables | 135,125 | 72,313 | 109,098 | |
| Other receivables | 9,807 | 8,820 | 7,718 | |
| Prepayments and accrued income | 11 | 14,601 | 8,763 | 7,318 |
| Total current receivables | 188,991 | 108,982 | 133,422 | |
| Cash and bank deposit | 425,997 | 372,677 | 365,351 | |
| Total current assets | 716,409 | 578,149 | 599,297 | |
| TOTAL ASSETS | 1,076,078 | 926,519 | 956,202 |
| KSEK Note |
30-09-2022 | 30-09-2021 | 31-12-2021 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| EQUITY | |||
| Restricted equity | |||
| Share capital (55,383,447 shares) | 1,385 | 1,365 | 1,371 |
| Statutory reserve | 11,327 | 11,327 | 11,327 |
| Total restricted equity | 12,712 | 12,692 | 12,698 |
| Unrestricted equity | |||
| Retained earnings | -1,087,307 | -984,054 | -984,054 |
| Share premium reserve | 1,927,396 | 1,819,118 | 1,853,781 |
| Result for the period | 30,996 | -85,194 | -103,253 |
| Total unrestricted equity | 871,085 | 749,870 | 766,474 |
| Total equity 10 |
883,797 | 762,562 | 779,172 |
| 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 stock | |||
| options program | 8,168 | 727 | 820 |
| Total long-term liabilities | 8,740 | 1,299 | 1,392 |
| Short-term liabilities | |||
| Trade payables | 37,923 | 26,046 | 47,341 |
| Other liabilities | 23,064 | 11,765 | 13,843 |
| Accrued expenses and deferred income | 119,068 | 121,361 | 110,968 |
| Total short-term liabilities | 180,055 | 159,172 | 172,152 |
| TOTAL EQUITY AND LIABILITIES | 1,076,078 | 926,519 | 956,202 |
| Key figures, MSEK | 2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Jan-Dec |
|---|---|---|---|---|---|
| Total revenue | 241 | 154 | 688 | 418 | 601 |
| Operating expenses | -184 | -139 | -560 | -454 | -628 |
| Operating result | 41 | -6 | 53 | -92 | -111 |
| Result for the period | 35 | -6 | 42 | -76 | -90 |
| Cash flow from operating activities | 54 | -4 | 56 | -106 | -143 |
| Cash and cash equivalents | 520 | 426 | 520 | 426 | 412 |
| Equity | 968 | 827 | 968 | 827 | 849 |
| Equity ratio in group, percent | 79% | 79% | 79% | 79% | 78% |
| Total assets | 1,234 | 1,046 | 1,234 | 1,046 | 1,082 |
| Weighted average number of shares, before dilution | 55,331,648 | 54,558,321 | 54,959,218 | 54,381,989 | 54,450,727 |
| Weighted average number of shares, after dilution | 57,663,176 | 56,709,939 | 57,032,020 | 56,082,965 | 56,227,742 |
| Earnings per share before dilution, SEK | 0.63 | -0.11 | 0.77 | -1.41 | -1.66 |
| Earnings per share after dilution, SEK | 0.61 | -0.11 | 0.74 | -1.41 | -1.66 |
| Equity per share before dilution, SEK | 17.50 | 15.17 | 17.62 | 15.22 | 15.59 |
| Equity per share after dilution, SEK | 16.79 | 14.59 | 16.98 | 14.75 | 15.10 |
| Number of employees at end of period | 170 | 146 | 170 | 146 | 148 |
| Number of employees in R&D at end of period | 93 | 83 | 93 | 83 | 83 |
| R&D costs as a percentage of operating expenses | 58% | 60% | 60% | 62% | 62% |
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 third quarter 2022 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 as for the group, unless otherwise stated in Note 2.2.
The most important accounting policies that are applied in the preparation of these consolidated financial statements are detailed below and are the same and consistent with those used in the preparation of Annual Report 2021, see www.camurus.com/investors/financial-reports.
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 RFR 2 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 two subscription warrant programs (TO) active for the company's employees. The programs were adopted by the Annual General Meeting (AGM) in 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.
Camurus has two Employee Stock Options Programs (ESOP) active for the company´s employees. The programs were adopted by the Annual General Meeting (AGM) in 2021 and 2022.
The options are granted free of charge and have a term approximately between three and almost four years from the grant date. Once vested, the options can be exercised during the 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 respective company's AGM in which the program was approved. ESOP 2021/2024 program comprises a maximum of 1,215,500 employee stock options while ESOP 2022/2026 a maximum of 1,000,000 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 total 1,846,400 employee options have been granted since programs launch, of which 102,000 to the CEO and 346,500 to other senior executives.
The fair value of the options when implementing the program have 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.
For further information about those programs, see the minutes from the 2021 and 2022 Annual General Meetings published on the company's website www.camurus.com.
Full exercise of allotted warrants and employee stock options as of 30 September, 2022 corresponds to a total of 2,089,571 shares and would result in a dilution of shareholders with 3.77 percent, for more information see the below summary.
If decided, but not yet granted employee options are fully exercised, a further total of 369,100, the total dilution of shareholders would increase to 4.44 percent.
| Change in existing incentive programs | Number of shares granted instruments may entitle to |
|---|---|
| 1 January, 2022 | 1,908,934 |
| Change during the January-June period 2022 Returned instruments |
|
| Incentive Program 2021/2024 | -85,250 |
| Exercised instruments | |
| TO2019/2022 | -178,359 |
| Granted instruments | |
| Incentive Program 2021/2024 | 11,250 |
| Incentive Program 2022/2026 | 856,000 |
| Total change | 603,641 |
| Number of shares granted instruments may entitle to as of 30 June, 2022 |
2,512,575 |
| Change during the third quarter 2022 Returned instruments |
|
| Incentive Program 2021/2024 | -46,500 |
| Exercised instruments | |
| TO2019/2022 | -376,504 |
| Total change | -423,004 |
| Number of shares granted instruments may entitle to as of 30 September, 2022 |
2,089,571 |
| Program | Number of shares subscribed warrants and options entitles to |
Potential dilution of the sub scribed warrants and options |
Subscription period |
Strike price SEK, for sub scription of shares upon exercise |
Market value2) | Number of employees partici pating in the program |
|---|---|---|---|---|---|---|
| TO2019/2022 | 42,5961) | 0.08%1) 15 May 2022- 15 Dec 2022 |
98.90 | 3 Jun 2019: SEK 11.10 | 63 | |
| TO2020/2023 | 200,5751) | 0.36%1) 15 May 2023- 15 Dec 2023 |
169.50 | 17 Aug 2020: SEK 44.70 14 Dec 2020: SEK 50.70 10 Mar 2021: SEK 75.50 |
40 | |
| ESOP2021/2024 | 990,400 | 1.79% | 1 Jun 2024- 16 Dec 2024 |
263.50 | 10 Jun 2021: SEK 61.18 | 123 |
| ESOP2022/2026 | 856,000 | 1.55% | 1 Jun 2025- 1 Mar 2026 |
237.40 | 1 Jun 2022: SEK 59.45 | 135 |
| Total | 2,089,571 | 3.77% |
1) No further allocation can be made.
2) 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.
The group reports a deferred tax asset of MSEK 328.7 as of 30 September, 2022. 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 licensee Braeburn received a Complete Response Letter from the FDA for Brixadi™ in December 2021, does not change the assessment.
Future revenues will mainly be generated from Camurus' own sales organization in markets where Camurus has 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 2021 (The Director's Report).
The Board of Directors has not changed its outlook about future risk and uncertainties development in relation to their outlook published in the interim report for the second quarter 2022.
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 |
2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Jan-Dec |
|---|---|---|---|---|---|
| Sales of development related | |||||
| goods and services | 862 | 1,951 | 11,579 | 4,847 | 6,456 |
| Licensing revenues and | |||||
| milestone payment | – | – | 8,920 | – | – |
| Product sale1) | 240,500 | 152,033 | 667,826 | 412,929 | 594,114 |
| 688,325 | 417,776 | 600,570 | |||
| Total 1) Related to Buvidal and episil |
241,362 | 153,984 | |||
| Revenues allocated by | 2022 | 2021 | 2022 | 2021 | 2021 |
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan-Dec | |
| 148,129 (15,450) |
91,679 (9,726) |
391,823 (44,113) |
252,182 (26,611) |
360,387 (47,373) |
|
| geographical area Europe (whereof Sweden) North America |
194 | 1,041 | 20,089 | 2,331 | 3,312 |
| Asia including Oceania | 93,039 | 61,264 | 276,413 | 163,263 | 236,871 |
Revenues during the quarter of approximately MSEK 91.8 (60.9) 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 | 2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Jan-Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders Weighted average number |
34,999 | -6,167 | 42,486 | -76,430 | -90,446 |
| of ordinary shares outstanding (thousands) |
55,332 | 54,558 | 54,959 | 54,382 | 54,451 |
| KSEK | 2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Jan-Dec |
|---|---|---|---|---|---|
| Result attributable to parent company shareholders Weighted average number of ordinary shares |
34,999 | -6,167 | 42,486 | -76,430 | -90,446 |
| outstanding (thousands) | 55,332 | 54,558 | 54,959 | 54,382 | 54,451 |
| Adjustment for warrants and options (thousands) |
2,332 | 2,152 | 2,073 | 1,701 | 1,777 |
| Weighted average number of ordinary shares used in calculation of earnings per share after dilution (thousands) |
57,663 | 56,710 | 57,032 | 56,083 | 56,228 |
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 | 30-09-2022 | 30-09-2021 | 31-12-2021 |
|---|---|---|---|
| Trade receivables | 169,338 | 94,947 | 135,994 |
| Derivatives - currency futures | |||
| (part of Other receivables) | – | 936 | – |
| Cash and cash equivalents | 519,541 | 426,477 | 411,575 |
| Total | 688,879 | 522,360 | 547,569 |
| Balance sheet liabilities, KSEK | 30-09-2022 | 30-09-2021 | 31-12-2021 |
| Trade payables | 46,467 | 31,598 | 52,857 |
| Derivatives - currency futures | |||
| (part of Other liabilities) | 4,195 | – | – |
| Other liabilities | 190 | 190 | 190 |
There were no related party transactions outside of the Camurus group during the period.
No receivables or liabilities existed as of 30 September, 2022.
Adjustment for non-cash items:
| KSEK | 2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Jan-Dec |
|---|---|---|---|---|---|
| Depreciation | 2,910 | 3,382 | 9,174 | 9,413 | 12,681 |
| Derivatives - | |||||
| currency futures | -3,234 | – | 4,195 | – | – |
| Employee options | 13,776 | 6,148 | 27,588 | 7,736 | 12,523 |
| Total | 13,452 | 9,530 | 40,957 | 17,149 | 25,204 |
Tax for the quarter amounted to MSEK -6.5 (0.5), an income tax driven by the positive result.
The change in equity is mainly attributable to the result during the period and the first and second exercise windows of program TO2019/2022 which led to the issuance of 554 863 new shares.
Following IFRS 5, Assets held for sale contains assets whose carrying amount will be recovered principally through a sale transaction instead of through continuing use and are measured at the lower of the carrying amount and fair value less costs to sell. Depreciation of such asset will cease when held for sale. At the end of Q2 (prior quarter), episil had been reclassified into this category with the following value:
Inventory MSEK 5.2 and Intangible assets MSEK 7.3.
On 8 July, 2022, Camurus announced the acquisition of its medical device product episil for treatment of oral pain due to oral mucositis by current partner Solasia in Japan. Camurus will receive a consideration of MEUR 1.8 plus a 20 percent royalty up to a maximum of MEUR 1.3 in exchange of the episil asset transfer. As a consequence of that transaction:
a) Asset held for sale amount reported in Q2 has been credited.
b) Profit from transaction is MSEK 6.5 and it is reported in the "Other operating income" line.
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the chief executive officer, 07.00 AM (CET) on 10 November, 2022.
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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