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Camurus

Quarterly Report Jul 15, 2022

3021_ir_2022-07-15_774e5673-d03d-4662-bfa6-70e144beb166.pdf

Quarterly Report

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INTERIM REPORT FOR THE SECOND QUARTER 2022

Q2 "For the first time and ahead of plan, Camurus entered profitability in the second quarter"

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.

Second quarter summary

Second quarter 2022

Total revenues SEK 227 million +64%

Product sales SEK 225 million +65%

Operating result SEK 7 million +SEK 67 million

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 (PIN 6658524#): https://financialhearings.com/ event/43530

April - June

  • Total revenues amounted to SEK 227 (138) million, an increase of 64% (55% at CER1 ), whereof product sales were SEK 225 (137) million, an increase of 65% (56% at CER)
  • Operating result was SEK 7 (-60) million, an increase of SEK 67 million
  • Cash position at the end of the quarter was SEK 428 (422) million
  • Number of patients treated with Buvidal® at the end of the quarter estimated to around 30,000
  • Buvidal 160mg launched in Australia after price and reimbursement approvals
  • Phase 2b-study of CAM2029 in patients with polycystic liver disease initiated
  • Topline results from exploratory Phase 2 study of CAM2043 indicated efficacy in Raynaud's Phenomenon

January - June

  • Total revenues amounted to SEK 447 (264) million, an increase of 69% (61% at CER1 ), whereof product sales were SEK 427 (261) million, an increase of 64% (56% at CER)
  • Operating result was SEK 12 (-86) million, an increase of SEK 98 million
  • Full year operating result guidance raised from SEK -60/+10 million to SEK -20/+40 million2

Events after the quarter

• episil® oral liquid for the treatment of oral pain due to oral mucositis acquired by Solasia Pharma K.K. in Japan

1) At constant exchange rates, January 2022.

2) Excluding milestone payments related to a potential approval of Brixadi™ in the US.

MSEK 2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Total revenues 227 138 64% 447 264 69% 601
whereof product sales 225 137 65% 427 261 64% 594
OPEX 196 179 10% 384 315 22% 628
Operating result 7 -60 N/A 12 -86 N/A -111
Result for the period 8 -48 N/A 7 -70 N/A -90
Result per share after dilution, of SEK 0.14 -0.89 N/A 0.13 -1.29 N/A -1.66
Cash position 428 422 1% 428 422 1% 412

"We raised our guidance for the full year operating result"

Revenue growth and profitability in the second quarter

Our positive development continued during the second quarter with increasing Buvidal patient numbers, improved financial result, and progress in our registration and Phase 3 programs in chronic pain and rare diseases. The strong, double-digit growth of Buvidal sales resulted in a historic first profitable quarter, improved cash position, and a raised full-year result guidance. After a positive first half of the year, we are well positioned to successfully deliver on our goals for the year and the long-term strategy.

Strong financial performance and raised guidance for the full year result 2022

A productive second quarter with strong financial development followed a solid first quarter for Camurus. Our key growth driver Buvidal, weekly and monthly depots for the treatment of opioid dependence, continued to gain patient shares and bring more people into treatment as access is improving, and the treatment is increasingly known and available to address the significant medical needs of patients with opioid dependence. The positive growth-trajectory of Buvidal is reflected in our strong financial performance in the second quarter and first half of the year.

Total revenues in the second quarter increased by 64 percent versus last year to SEK 227 million with product sales growing by 65 percent to SEK 225 million. The strong sales performance led to a second quarter in a row with positive operating result of SEK 7 million. For the first time and ahead of plan, Camurus entered profitability in the second

quarter with a net result of SEK 8 million compared to last year's loss of SEK 48 million. We ended the first half of the year with a cash position of SEK 428 million and no debt, providing the financial means and flexibility to continue to invest in our R&D pipeline, develop our commercial infrastructure, and diversify through focused business development.

Based on the results for the first half year and a positive view on the future, we raised our guidance for the full year operating result from loss to profit at the midpoint (see page 16).

Increased market shares, improved access to treatment and market expansion

Product sales increased by double-digit for the 12th quarter in a row and by 11 percent compared to previous quarter.

Buvidal continued to gain market share in the second quarter, primarily driven by growth in the established markets in the Nordics, the UK and Australia, and with increasing

"We have decided on a donation, finalized manufacturing and initiated shipment of Buvidal to Ukraine"

contributions from Spain, France and the Middle East. As expected, we saw strong growth in England as funding for the Government's ambition to create a world-class treatment system started to become available to clinics and patients. In Spain more than 90 percent of patients now have access to treatment with Buvidal and we are expecting to see accelerated growth in the coming quarters. Notably, we continued to see significant growth in Finland, where Buvidal already has a very high patient share of around 70 percent. In total, we estimate that about 30,000 patients were in treatment with Buvidal at the end of the period.

Aside from our efforts to further improve access to Buvidal in existing markets, we have advanced several regulatory processes as well as pricing and reimbursement approvals, which are expected to come during the second half of the year. In Australia, we received reimbursement for the new 160 mg dose as well as direct initiation of new to treatment patients, further strengthening our leading position where we already have an 80 percent share of the long-acting treatment market for opioid dependence.

The continued positive response we receive on our different markets strengthens our positive view on the importance and future potential of Buvidal.

During the quarter, we received a request from the Ministry of Health in Ukraine to provide Buvidal as humanitarian aid for patients in need. Despite the difficult situation, the country is taking all measures to ensure patients are receiving adequate treatment. After discussions with the Ministry of Health, healthcare professionals, patient representatives and World Health Organization (WHO) we have decided on a donation, finalized manufacturing and initiated shipment of Buvidal to Ukraine.

In the US, our licensee Braeburn has informed Camurus that inspections by the FDA have been initiated at their thirdparty manufacturer for Brixadi™. Depending on the inspection outcome, Braeburn will resubmit the new drug application (NDA) as soon as practicable. Once the NDA is resubmitted, the review period is expected to be either two months for a Class 1 review, or six months if the agency decides on a Class 2 review.

Progressing pipeline with significant near-term milestones

During the second quarter, we advanced several regulatory processes and late-stage clinical programs. The review processes of our applications for extended Buvidal indication to include chronic pain progressed in the EU and Australia. In accordance with the procedure, Request for Supplementary Information has been received from the EMA's Committee for Medicinal Products for Human Use (CHMP) and a response is being prepared. CHMP Opinion is expected in the fourth quarter 2022. In Australia, questions are expected after the summer, followed by an approval decision during the first half of 2023. In parallel, we are working with pre-launch preparations and publications of data.

For our long-acting octreotide product, CAM2029, two Phase 3 studies in acromegaly continued to progress and recruitment is expected to be completed in the autumn followed by topline results from the randomized efficacy study in the first half of 2023. Our clinical team and collaborators have done a tremendous job resulting in operational milestones and activation of new clinical sites to compensate planned new recruitments in Russia, while ensuring that patients already in the studies can complete their treatment and study assessments.

Alongside finalizing the Phase 3 program in acromegaly, recruitment has continued to progress in the pivotal Phase 3 SORENTO study in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET). The study design and other information about SORENTO was presented at the European

"Significant headway on our key goals and strategy for growth and long-term profitability" Congress of Endocrinology in Milan in May, and at the ASCO Annual Meeting in Chicago in June. The primary objective of the study is to demonstrate superiority in progression-free survival with CAM2029 versus standard of care, with overall survival, quality of life and treatment satisfaction being important secondary outcomes. CAM2029 is designed for easy administration by patients using a prefilled syringe or state-of the-art pen device for improved convenience and patient autonomy.

During the period we also started recruitment of patients in a new Phase 2b study of CAM2029 for the treatment of polycystic liver disease (PLD). There is a high unmet need in PLD and no approved therapies.

We also received top-line results from an exploratory Phase 2 study of weekly subcutaneous treprostinil in patients with Raynaud's Phenomenon secondary to systemic sclerosis (scleroderma). The study did not meet the primary endpoint of statistically significant effect on finger temperatures after a cold provocation test 6 hours post dosing. However, several secondary endpoints were met, including a positive treatment difference for the primary endpoint measure 24 hours post dose and improvements of the patient reported Raynaud's Condition Score on Day 8 and 15 post dosing. There were no serious side effects in the study and the safety profile was generally comparable to that observed in our previous Phase 1 trial and reported for approved treprostinil products for subcutaneous infusion. Based on the results of the study, we will evaluate the future of the CAM2043 program in scleroderma-related Raynaud's Phenomenon together with our investigators and experts before progressing with further developments.

Regarding the ongoing development program of a weekly setmelanotide depot, recruitment continued in our partner

Rhythm Pharmaceutical's ongoing Phase 3 switch study in patients with Bardet-Biedl Syndrome (BBS) and other rare diseases of obesity. In parallel, preparations are ongoing for start of a second Phase 3 study in new to treatment patients with BBS later in the year.

After the quarter, we announced that our partner Solasia in Japan aquired our medical device product episil for the treatment of oral pain due to oral mucositis. The agreement ensures continued development and access to episil for patients. With its experience and focus on oncology and supportive cancer, Solasia is well positioned to continue to commercialize episil, while the agreement allows Camurus to focus on the development and sales of innovative pharmaceutical products in CNS and rare disease areas.

Focus on commercial execution and diversifying our business

In the second quarter, we made significant headway on our key goals and strategy for growth and long-term profitability, while investing heavily in innovation and the R&D pipeline. In parallel, we continued building the organization, preparing for expansions into new markets, and implementing our sustainability strategy across the company.

I am proud of the high engagement and excellent performance of our teams and our continued progress of the company during the second quarter. Wishing you all an enjoyable and relaxing summer.

Fredrik Tiberg, President and Chief Executive Officer

Products and Pipeline

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.

Commercial operations

Buvidal® – Treatment of opioid dependence

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 real-world 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

Status Q2 2022

Commercial development

  • Product sales of SEK 225 million, +65% vs. Q2 2021 and +11% vs. Q1 2022
  • Estimated 30,000 patients in treatment with Buvidal end of Q2 vs. 27,000 Q1
  • Strong double-digit (>20%) growth in UK, Nordics and Spain
  • Expected good progress in England, Buvidal now offered in more than 60% of municipalities
  • Completion of regional access processes in Spain and Buvidal now available for 90% of suitable patients
  • Launch of Buvidal 160mg monthly dose and treatment initiation in Australia after receiving new pricing and reimbursement approvals
  • New pre-license sales orders for Buvidal in MENA
  • Ongoing pricing and reimbursement processes in a number of countries continued to progress after delays due to the pandemic. Outcomes are expected in the coming quarters.

Medical affairs

  • Presentation of experiences by healthcare professionals and patients on Buvidal presented at IOTOD (virtual, 11-12 May), EUROPAD (Pisa, 20-22 May), Congrés de l'ALBATROS (Paris, 7-8 June) and Intedisziplinärer Kongress für Suchtmedizin (Munich, 30 June-2 July)
  • Two scientific publications of patient perspectives of Buvidal treatment from Scotland in homeless people and from Swedish patients:
    • Matheson C., et al. Long-acting depot buprenorphine in people who are homeless: Views and experiences. J Subst Abuse Treat. 2022; 139:108781.
  • Johnson B., et al. Patient perspectives on depot buprenorphine treatment for opioid addiction - a qualitative interview study. Subst Abuse Treat Prev Policy. 2022; 17: 40.
  • Buvidal nominated for the Prix Galien 2022 award6

Regulatory processes

  • Seven market authorization applications currently under review in the Middle East and North Africa region
  • Braeburn informed Camurus about initiated FDA-inspection of the company's third-party manufacturer. Depending on the inspection outcome, Braeburn intend to resubmit the new drug application (NDA) as soon as practicable.

Pipeline development

LIFE-CYCLE MANAGEMENT PROGRAMS

CAM2038 (Buvidal) – Chronic pain

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.

Status Q2 2022

  • European Medicines Agency (EMA) review of a regulatory application to extend the indication in the EU to include treatment of chronic pain progressed according to plan
  • Request for Supplementary Information from the EMA's Committee for Medicinal Products for Human Use (CHMP). Answers being prepared and CHMP opinion expected in Q4 2022.
  • Australian Therapeutic Goods Agency (TGA) review of a corresponding extension application progressing. Approval decision expected H1 2023.

PROGRESS IN KEY PIPELINE PROGRAMS

CAM2029 – Acromegaly, NET and PLD

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.7 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.8,9

Status Q2 2022

Acromegaly

  • New clinical sites activated and initiated to replace planned recruitments at sites impacted by the war on Ukraine
  • Patient recruitment in Phase 3 efficacy and long-term safety studies in final stages, and expected to be completed in early Q4 202210,11
  • Statistical Analysis Plan for the pivotal Phase 3 efficacy study agreed with the FDA in a Type C meeting

GEP-NET

  • Continued screening and enrollment of patients as well as activation of clinical sites in the SORENTO study with 50 of 95 activated in a total of 11 countries12
  • SORENTO study presented at European Congress of Endocrinology 2022 (Milan 21-24 May) and at ASCO (Chicago, 2-6 June)

PLD

• Recruitment started in Phase 2b study POSITANO (POlycystic liver Safety and effIcacy TriAl with subcutaNeous Octreotide)13

CAM4072 – Genetic obesity disorders (Rhythm Pharmaceuticals)

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.

Status Q2 2022

  • Recruitment continued in Phase 3 switch study evaluating a weekly setmelanotide formulation for the treatment of patients with the Bardet-Biedl syndrome (BBS) and other rare genetic obsesity disorders14
  • A second Phase 3 study in patients with BBS who have not previously received treatment (de novo patients) is planned to start in H2 202214

CAM2043 – Pulmonary arterial hypertension and Raynaud's phenomenon

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.

Status Q2 2022

  • Topline results of exploratory Phase 2 study of CAM2043
  • The study did not meet the primary endpoint 6 hours post dosing, but several secondary endpoints, including the primary endpoint measure at 24 hours post dose, and improvements of the patient reported Raynaud's Condition Score Day 8 and Day 15 post dosing. Safety profile comparable to that observed in previous CAM2043 Phase 1 study and for approved treprostinil products for subcutaneous infusion.
  • New patent granted in the US covering CAM2043

MEDICAL DEVICE

episil® – Oral mucositis

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.

Status Q2 2022

  • After the period, Camurus and its partner Solasia Pharma K.K. jointly announced the entering of an agreement in which Solasia has acquired episil15
  • Under the terms of the agreement, Solasia has obtained the assets and relevant licensing rights to continue developing, manufacturing and commercializing episil
  • Camurus will continue to provide certain assistance services at Solasia's request during a transition period up to May 2024

Corporate development

Targeting sustainable and profitable growth

Second quarter 2022 was the first quarter in which Camurus achieved positive half-year and quarterly results, as well as positive cashflow from operations.In parallel, the company will invest around half a billion SEK this year 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 latestage product candidates may fluctuate with time and thereby impact profitability over the next few quarters.

Sustainability

During the period Camurus continued to implement its sustainability strategy and strengthen the organization. Ongoing activities include:

  • Mapping of key suppliers to improve monitoring, oversight and reporting on environmental and social responsibilities visavi the supply chain
  • Improve the company's collection of sustainability data with special focus on environmental and climate-related data, to improve follow-up and control
  • The company supported "Take on Addiction" campaign organized by SMART Recovery International, a global community of more than 2000 mutual-support groups in over 25 countries. The campaign took place in April with the goal to help reduce stigma associated with addiction.
  • Collaboration with Ukraine's Ministry of Health regarding request for humanitarian aid supply of Buvidal for opioid dependence treatment

For more information about Camurus' sustainability goals and performance, see the sustainability chapter in Camurus' Annual Report 2021, available on www.camurus.com.

Organizational update

As of 30 June:

  • Andrew McLean has resigned his position as VP Corporate Development & Legal, Senior Counsel and member of the Executive Management Team
  • Camurus appointed Jonas Duborn as the company's Head of Compliance, Europe and Australia. The appointment further strenthens our focus on responsible business practices – one of the key pillars in Camurus' strategy and sustainability work.

References

  1. Buvidal SmPC, https://www.ema.europa.eu/en/ documents/product-information/buvidal-eparproduct-information_en.pdf 2. Walsh L, et al. JAMA Psychiatry. 2017;74(9):894-902. 3. Lintzeris N, et al. JAMA Network Open. 2021;4(5):e219041. 4. Lofwall MR, et al. JAMA Intern Med. 2018;178(6);764–773. 5. Frost M, et al. Addiction. 2019;114:1416–1426. 6. https://www.prixgalien.fr/candidats/. 7. Tiberg F, et al. Br J Clin Pharmacol. 2015;80:460-72. 8.Prescribing Information SANDOSTATIN® LAR, https://www.accessdata.fda.gov/drugsatfda_docs/ label/2021/021008s041lbl.pdf 9. Prescribing Information SOMATULINE®, https://www.accessdata.fda.gov/drugsatfda_docs/ label/2019/022074s024lbl.pdf 10. https://clinicaltrials.gov/ct2/show/NCT04125836 11. https://clinicaltrials.gov/ct2/show/NCT04076462 12. https://clinicaltrials.gov/ct2/show/NCT05050942 13. https://clinicaltrials.gov/ct2/show/NCT05281328 14. https://ir.rhythmtx.com/news-releases/newsrelease-details/rhythm-pharmaceuticals-announcesfirst-patients-dosed-daybreak

  2. https://www.camurus.com/media/press-releases/2022/ solasia-acquires-episil-oral-liquid-business-from-camurus/

Financial statements

Revenues

Total revenues during the quarter amounted to MSEK 226.7 (137.9), an increase by 64 percent (55 percent at CER1 ).

Product sales were MSEK 225.0 (136.6), corresponding to an increase of 65 percent (56 percent at CER) compared to the second quarter 2021 and 11 percent increase versus prior quarter.

Half-year total revenues were MSEK 447.0 (263.8), up 69 percent compared to the same period 2021. Product sales were MSEK 427.3 (260.9), up 64 percent. For further information, see Note 4.

Operating result

Marketing and distribution costs were MSEK 71.1 (55.5) in the quarter, and for the half-year MSEK 128.3 (100.0), 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 8.7 (6.2) and for the half-year MSEK 15.6 (16.0), basically aligned with last year as of June year to date.

R&D costs, including depreciation and amortization of tangible and intangible assets, were MSEK 115.9 (117.0) for the quarter and for the half-year MSEK 232.1 (198.9). Regarding second quarter, the slight decline is driven by one time set up fees in 2021 for GEP-NET and PLD studies summing up to MSEK 20. Year to date, the increase compared to previous year 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 6.9 (-59.8), and for the half-year MSEK 11.7 (-86.1).

Financial items and tax

Financial items in the period were MSEK -0.3 (-0.3) and MSEK -0.6 (-0.6) for the first half of the year.

Tax in the quarter was MSEK 1.6 (11.7), an income driven by tax update from Q1 and for January-June MSEK -3.6 (16.4).

Result for the period

The result for the period amounted to MSEK 8.2 (-48.4) and for the half-year MSEK 7.5 (-70.3).

Earnings per share before dilution were SEK 0.15 (-0.89) for the period and for the half-year SEK 0.14 (-1.29). Earnings per share after dilution were SEK 0.14 (-0.89) for the period and for the half-year SEK 0.13 (-1.29).

Cash flow and investment

Cash flow from operating activities, before change in working capital, amounted to MSEK 11.0 (-56.0) for the quarter and MSEK 32.5 (-80.0) for the half-year. The difference compared to previous year is driven by operating result improvement and adjusments 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 -1.4 (14.7) in the quarter and during the half-year by MSEK -30.4 (-22.0).

Cash flow from investing activities in the quarter was MSEK -0.2 (-1.3) and MSEK -1.4 (-1.6) year to date.

Cash flow from financing activities was MSEK 16.3 (38.4) in the quarter and relates to payments for the exercise of warrants in TO2019/2022. Year to date, the cash flow was MSEK 13.9 (65.3).

1) At constant exchange rates in January 2022.

Financial position

The cash position for the group as of 30 June, 2022 was MSEK 428.1 (421.9).

There were no loans as of 30 June, 2022 and no loans have been taken since this date.

Consolidated equity as of 30 June, 2022 was MSEK 887.3 (819.7). The difference 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 2021 and TO2019/2022 during 2022.

Total assets for the group were MSEK 1,132.7 (1,045.7).

Parent company

The company's total revenue in the quarter amounted to MSEK 219.6 (133.4) and in the first half year MSEK 431.7 (253.5). The result after tax in quarter was MSEK 5.0 (-51.2) and for January-June MSEK 0.9 (-76.1).

On 30 June, 2022, equity in the parent company amounted to MSEK 808.6 (757.8) and total assets to MSEK 999.8 (929.3), of which MSEK 370.8 (380.1) were cash and cash equivalents.

Acquisitions

No acquisitions or divestments have taken place during the period. See paragraph Events after the balance sheet date on page 16.

Camurus' share

Camurus' share is listed on Nasdaq Stockholm.

At the end of the period, the total number of shares and votes was 55,006,943 (54,538,571). 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-June respectively, earnings after tax were negatively impacted by MSEK 0.5 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 6.7 after tax during the quarter and MSEK 10.8 during the first half-year.

For further information about the programs, see Note 2.3.

Personnel

At the end of the period, Camurus had 157 (140) employees, of whom 88 (77) were within research and development and medical affairs, 55 (48) within business development and marketing and sales, and 13 (14) within administration. The number of employees, in terms of full-time equivalents, amounted to 148 (127) during the quarter and 145 (125) during the first six months.

Financial outlook for 20221

Following second quarter performance, the company has updated the full year 2022 guidance as shown below:

  • Product sales MSEK 875 to 925, +47 56 percent2 (reiterared)
  • Total revenue MSEK 900 to 950, +50 58 percent2 (reiterated)
  • Operating result MSEK -20 to 40 vs. prior guidance from MSEK -60 to 10, an increase of ~MSEK 35 at the mid-points of the two intervals.

1The outlook excludes milestone payments related to a potential approval of Brixadi™ in the US. 2Based on exchange rates in January 2022.

Audit

This report has not been reviewed by the company's auditor.

Forward-looking statements

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.

Events after the balance sheet date

After quarter close, on 8 July, 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.

Financial calendar 2022

Q3 Interim Report 2022 10 November, 2022

Further information

For further information, please contact: Fredrik Tiberg, President and CEO Tel. +46 46 286 46 92, e-mail: [email protected]

Lund, Sweden, 15 July, 2022 Camurus AB Board of Directors

KSEK
Note
2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Total revenue
4
226,682 137,895 446,963 263,792 600,570
Cost of goods sold -25,063 -20,592 -51,246 -36,264 -85,352
Gross profit 201,619 117,303 395,717 227,528 515,218
Marketing and distribution costs -71,128 -55,453 -128,293 -99,987 -212,248
Administrative expenses -8,744 -6,205 -15,545 -16,014 -27,563
Research and development costs -115,854 -116,957 -232,111 -198,948 -388,688
Other operating income 1,022 1,526 357 1,302 2,707
Other operating expenses -8,419
Operating result 6,915 -59,786 11,706 -86,119 -110,574
Finance income 53 43 95 85 171
Finance expenses -346 -330 -681 -662 -1,365
Net financial items -293 -287 -586 -577 -1,194
Result before tax 6,622 -60,073 11,120 -86,696 -111,768
Income tax
9
1,617 11,684 -3,633 16,433 21,322
Result for the period1)
5
8,239 -48,389 7,487 -70,263 -90,446
Other comprehensive income
Exchange-rate differences 1,465 -607 2,363 705 1,587
Comprehensive income for the period 9,704 -48,996 9,850 -69,558 -88,859

1) All attributable to parent company shareholders.

Earnings per share based on earnings attributable to parent company shareholders for the period (in SEK per share)

2022 2021 2022 2021 2021
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
Earnings per share before dilution, SEK 0.15 -0.89 0.14 -1.29 -1.66
Earnings per share after dilution, SEK 0.14 -0.89 0.13 -1.29 -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
30-06-2022 30-06-2021 31-12-2021
ASSETS
Fixed assets
Intangible assets
Capitalized development expenditure 24,489 34,980 33,713
Tangible assets
Lease assets 21,805 22,350 24,847
Equipment 10,034 8,751 9,882
Financial assets
Deferred tax receivables
9
334,577 324,909 334,153
Total fixed assets 390,905 390,990 402,595
Current assets
Inventories
Finished goods and goods for resale 87,461 58,880 53,121
Raw material 29,961 47,000 54,081
Total inventories 117,422 105,880 107,202
Current receivables
Trade receivables 151,244 101,974 135,994
Other receivables 19,658 16,345 17,887
Prepayments and accrued income 12,901 8,649 6,644
Total current receivables
6
183,803 126,968 160,525
Cash and cash equivalents 428,132 421,894 411,575
Assets held for sale
11
12,443
Total current assets 741,800 654,742 679,302
TOTAL ASSETS 1,132,705 1,045,732 1,081,897
KSEK
Note
30-06-2022 30-06-2021 31-12-2021
EQUITY AND LIABILITIES
EQUITY
Equity attributable to
parent company shareholders
Share capital 1,375 1,364 1,371
Other contributed capital 1,915,968 1,838,871 1,887,395
Retained earnings, including
comprehensive income for the period -1,030,008 -1,020,557 -1,039,858
Total equity
10
887,335 819,678 848,908
LIABILITIES
Long-term liabilities
Lease liabilities 15,600 17,836 18,925
Social security costs for employee options 4,166 326 1,019
Total long-term liabilities 19,766 18,162 19,944
Short-term liabilities
Trade payables 40,106 31,603 52,857
Lease liabilities 6,700 5,101 6,731
Income taxes 5,302 7,505 6,936
Other liabilities 32,595 17,118 20,960
Accrued expenses and deferred income 140,901 146,565 125,561
Total short-term liabilities 6 225,604 207,892 213,045
TOTAL EQUITY AND LIABILITIES 1,132,705 1,045,732 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 -69,558 -69,558
Transactions with shareholders
Exercise of warrants 8 40,681 40,689
Employee stock options program 1,262 1,262
Issuance costs, net after deferred tax -399 -399
Warrants issued 243 243
Closing balance 30 June, 2021 1,364 1,838,871 -1,020,557 819,678
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 9 850 9 850
Transactions with shareholders
Exercise of warrants 4 17,635 17,639
Employee stock options program 10,665 10,665
Issuance costs, net after deferred tax 272 272
Closing balance 30 June, 2022 10 1,375 1,915,968 -1,030,008 887,335
KSEK
Note
2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Operating activities
Operating profit/loss before financial items 6,915 -59,786 11,706 -86,119 -110,574
Adjustments for non-cash items
8
10,422 4,624 27,505 7,619 25,204
Interest received 53 43 95 85 171
Interest paid -346 -330 -681 -662 -1,365
Income taxes paid -6,060 -509 -6,112 -904 -3,540
Cashflow from operating activities before change 10,984 -55,958 32,513 -79,981 -90,104
in working capital
Increase/decrease in inventories -8,244 3,358 -14,724 5,469 4,147
Increase/decrease in trade receivables -3,838 -8,308 -13,222 -49,783 -83,803
Increase/decrease in other current receivables 4,774 -5,321 -6,343 -9,268 -8,805
Increase/decrease in trade payables 10,900 -17,549 -12,964 10,891 32,145
Increase/decrease in other current operating liabilities -4,960 42,531 16,831 20,724 2,993
Cash flow from changes in working capital -1,368 14,711 -30,422 -21,967 -53,323
Cash flow from operating activities 9,616 -41,247 2,091 -101,948 -143,427
Investing activities
Acquisition of intangible assets -296 -296 -952
Acquisition of tangible assets -232 -988 -1,432 -1,318 -3,991
Cash flow from investing activities -232 -1,284 -1,432 -1,614 -4,943
Financing activities
Amortization of lease liabilities -1,697 -1,283 -3,356 -2,551 -7,142
Share issue after issuance cost 17,982 39,714 17,982 67,617 105,803
Warrants issued 243 243
Other long-term receivables -739
Cash flow from financing activities 16,285 38,431 13,887 65,309 98,904
Net cash flow for the period 25,669 -4,100 14,546 -38,253 -49,466
Cash and cash equivalents at beginning of the period 399,850 427,822 411,575 461,793 461,793
Translation difference in cash flow and liquid assets 2,613 -1,828 2,011 -1,646 -752
Cash and cash equivalents at end of the period 428,132 421,894 428,132 421,894 411,575
KSEK
Note
2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Net sales 219,572 133,436 431,651 253,544 571,464
Cost of goods sold -30,807 -19,146 -57,034 -31,215 -76,058
Gross profit 188,765 -114,290 374,617 222,329 495,406
Marketing and distribution costs -63,484 -58,940 -119,791 -108,198 -219,635
Administrative expenses -8,807 -6,246 -15,649 -16,107 -27,853
Research and development costs -115,049 -114,816 -229,071 -194,608 -380,390
Other operating income 872 1,212 1,192 2,015
Other operating expenses -8,497
Operating result 2,297 -64,500 1,609 -95,392 -130,457
Interest income and similar items 53 43 95 85 171
Interest expense and similar items -12 -24 -31 -25 -46
Result after financial items 2,338 -64,481 1,673 -95,332 -130,332
Result before tax 2,338 -64,481 1,673 -95,332 -130,332
Tax on result for the period 2,711 13,264 -776 19,271 27,079
Result for the period 5,049 -51,217 897 -76,061 -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
30-06-2022 30-06-2021 31-12-2021
ASSETS
Fixed assets
Tangible assets
Equipment 9,924 8,615 9,766
Financial assets
Interests in group companies 9,982 3,403 6,759
Other financial assets 739
Deferred tax assets 339,533 332,468 340,380
Total fixed assets 360,178 344,486 356,905
Current assets
Inventories
Finished goods and goods for resale 72,076 51,002 46,443
Raw material 34,528 47,000 54,081
Total inventories 106,604 98,002 100,524
Current receivables
Receivables subsidiaries 18,340 6,772 9,288
Trade receivables 119,128 82,422 109,098
Other receivables 11,502 7,924 7,718
Prepayments and accrued income 13,276 9,648 7,318
Total current receivables 162,246 106,766 133,422
Cash and bank deposit 370,775 380,091 365,351
Total current assets 639,625 584,859 599,297
TOTAL ASSETS 999,803 929,345 956,202
KSEK
Note
30-06-2022 30-06-2021 31-12-2021
EQUITY AND LIABILITIES
EQUITY
Restricted equity
Share capital (55,006,943 shares) 1,375 1,364 1,371
Statutory reserve 11,327 11,327 11,327
Total restricted equity 12,702 12,691 12,698
Unrestricted equity
Retained earnings -1,087,307 -984,054 -984,054
Share premium reserve 1,882,353 1,805,257 1,853,781
Result for the period 897 -76,061 -103,253
Total unrestricted equity 795,943 745,142 766,474
Total equity
10
808,645 757,833 779,172
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
3,396 252 820
Total long-term liabilities 3,968 824 1,392
Short-term liabilities
Trade payables 35,097 25,419 47,341
Other liabilities 25,496 12,524 13,843
Accrued expenses and deferred income 123,111 129,259 110,968
Total short-term liabilities 183,704 167,202 172,152
TOTAL EQUITY AND LIABILITIES 999,803 929,345 956,202
Key figures, MSEK 2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Total revenue 227 138 447 264 601
Operating expenses -196 -179 -376 -315 -628
Operating result 7 -60 12 -86 -111
Result for the period 8 -48 7 -70 -90
Cash flow from operating activities 10 -41 2 -102 -143
Cash and cash equivalents 428 422 428 422 412
Equity 887 820 887 820 849
Equity ratio in group, percent 78% 78% 78% 78% 78%
Total assets 1,133 1,046 1,133 1,046 1,082
Weighted average number of shares, before dilution 54,892,212 54,349,123 54,860,574 54,292,362 54,450,727
Weighted average number of shares, after dilution 56,940,455 55,887,516 56,830,419 55,764,282 56,227,742
Earnings per share before dilution, SEK 0.15 -0.89 0.14 -1.29 -1.66
Earnings per share after dilution, SEK 0.14 -0.89 0.13 -1.29 -1.66
Equity per share before dilution, SEK 16.17 15.08 16.17 15.10 15.59
Equity per share after dilution, SEK 15.58 14.67 15.61 14.70 15.10
Number of employees at end of period 157 140 157 140 148
Number of employees in R&D at end of period 88 77 88 77 83
R&D costs as a percentage of operating expenses 59% 65% 62% 63% 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)

Note 1 General information

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 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.

Note 2 Summary of key accounting policies

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 camurus.com/Investors/Financial Reports.

2.1 BASIS OF PREPARATION OF REPORTS

2.1.1 Changes to accounting policies and disclosures

No new or revised IFRS standards, with any material impact on the group, have come into force.

2.1.2 Derivatives

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.

2.2 PARENT COMPANY'S ACCOUNTING POLICIES

The parent company applies accounting policies that differ from those of the group in the cases stated below.

Internally generated intangible assets

All expenses that relate to the development of internally generated intangible assets are recognized as expenses as they arise.

Interests in subsidiaries

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

Group contributions paid by the parent company to subsidiaries and group contributions received from subsidiaries by the parent company are recognized as appropriations.

Financial instruments

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.

2.3 SHARE-BASED PAYMENTS

2.3.1 Subscription warrant programs

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.

2.3.2 Employee option program

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 1,892,900 employee options have been granted since programs launch, of which 102,000 to the CEO and 369,000 to other senior executives.

Calculation of fair value of employee stock option programs

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.

Summary of ongoing incentive programs (number of shares)

Full exercise of allotted warrants and employee stock options as of 30 June, 2022 corresponds to a total of 2,512,575 shares and would result in a dilution of shareholders with 4.57 percent, for more information see the below summary.

If decided, but not yet granted employee options are fully exercised, a further total of 322,600, the total dilution of shareholders would increase to 5.15 percent.

Change in existing incentive programs Number of shares granted
instruments may entitle to
1 January, 2022 1,908,934
Change during the first quarter 2022
Returned instruments
Incentive Program 2021/2024 -68,750
Total change -68,750
Number of shares granted instruments may
entitle to as of 31 March, 2022
1,840,184
Change during the second quarter 2022
Returned instruments
Incentive Program 2021/2024
-16,500
Exercised instruments
TO2019/2022 -178,359
Granted instruments
Incentive Program 2021/2024 11,250
Incentive Program 2022/2026 856,000
Total change 672,391
Number of shares granted instruments may
entitle to as of 30 June, 2022
2,512,575
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 419,1001) 0.76%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 1,036,900 1.89% 1 Jun 2024-
16 Dec 2024
263.50 10 Jun 2021: SEK 61.18 129
ESOP2022/2026 856,000 1.56% 1 Jun 2025-
1 Mar 2026
237.40 1 Jun 2022: SEK 59.45 135
Total 2,512,575 4.57%

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.

Note 3 Significant risks and uncertainties

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 334.6 as of 30 June, 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 partner 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 first quarter 2022.

Note 4 Segment information

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.

Group-wide information

To follow is a breakdown of revenues from all products and services.

Revenues allocated by
products and services
2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Sales of development related
goods and services 1,674 1,296 10,717 2,896 6,456
Licensing revenues and
milestone payment 8,920
Product sale1) 225,008 136,599 427,326 260,896 594,114
Total 226,682 137,895 446,963 263,792 600,570
Revenues allocated by
geographical area
2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Europe 120,914 83,199 243,694 160,503 360,387
(whereof Sweden) (16,288) (9,537) (28,663) (16,885) (47,373)
North America 903 647 19,895 1,290 3,312
Asia including Oceania 104,865 54,049 183,374 101,999 236,871
Total 226,682 137,895 446,963 263,792 600,570

Revenues during the quarter of approximately MSEK 86.8 (50.2) relate to one single external customer.

99.8 (99.8) percent of the group's fixed assets are located in Sweden.

Note 5 Earnings per share

a) Before dilution

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.

b) After dilution

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
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Result attributable to parent
company shareholders
Weighted average number
8,239 -48,389 7,487 -70,263 -90,446
of ordinary shares
outstanding (thousands)
54,892 54,349 54,861 54,292 54,451
KSEK 2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Result attributable to parent
company shareholders
Weighted average number
8,239 -48,389 7,487 -70,263 -90,446
of ordinary shares
outstanding (thousands)
54,892 54,349 54,861 54,292 54,451
Adjustment for warrants
and options (thousands)
2,048 1,538 1,970 1,472 1,777
Weighted average number of
ordinary shares used in
calculation of earnings per
share after dilution (thousands)
56,940 55,888 56,830 55,764 56,228

Note 6 Financial instruments – Fair value of financial assets and liabilities

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 30-06-2022 30-06-2021 31-12-2021
Trade receivables 151,244 101,974 135,994
Derivatives - currency futures
(part of Other receivables) 1,257
Cash and cash equivalents 428,132 421,894 411,575
Total 579,376 525,125 547,569
Balance sheet liabilities, KSEK 30-06-2022 30-06-2021 31-12-2021
Trade payables 40,106 31,603 52,857
Derivatives - currency futures
(part of Other liabilities) 7,429
Other liabilities 190 190 190
Total 47,725 31,793 53,047

Note 7 Related party transaction

There were no related party transactions outside of the Camurus group during the period.

No receivables or liabilities existed as of 30 June, 2022.

Note 8 Information on cash flow

Adjustment for non-cash items:

KSEK 2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2021
Jan-Dec
Depreciation 3,127 3,036 6,264 6,031 12,681
Derivatives -
currency futures -1,290 7,429
Employee options 8,585 1,588 13,811 1,588 12,523
Total 10,422 4,624 27,504 7,619 25,204

Note 9 Tax

Tax for the quarter amounted to MSEK 1.6 (11.7), an income tax driven by Q1 tax expense update.

Note 10 Equity

The change in equity for the quarter is mainly attributable to the result during the period and first window of program TO2019/2022 which led to the issuance of 178 359 new shares.

Note 11 Assets held for sale

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.

As of end of the quarter, episil® has been reclassified into this category with the following value:

a) Inventory MSEK 5.2 and Intangible assets MSEK 7.3,

b) No liabilities exist as of the quarter related to episil.

As mentioned in the section covering Events after the balance sheet date, on 8 July, Camurus announced the acquisition of its medical device product episil for treatment of oral pain due to oral mucositis to 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.

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 15 June, 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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