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Bavarian Nordic — Interim / Quarterly Report 2016
Nov 9, 2016
3354_rns_2016-11-09_1c6c3f93-04ce-45ab-bae0-701a1189082d.pdf
Interim / Quarterly Report
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BAVARIAN NORDIC
Interim Financial Report
for the Period January 1 to September 30, 2016
Bavarian Nordic A/S
Hejreskovvej 10A
DK-3490 Kvistgaard
Denmark
CVR-No. DK 16 27 11 87
Management’s Review ... 2
Financial Statement for the Period January 1 - September 30, 2016 ... 2
Product Pipeline ... 4
Other Developments ... 10
Share Information ... 10
Statement from the Board of Directors and Corporate Management ... 12
Financial Statements ... 13
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Management's Review
Financial Statement for the Period January 1 - September 30, 2016
Financial statements are un-audited. Comparison figures for the same period 2015 are stated in parentheses.
- Revenue generated for the nine months ending September 30, 2016 was DKK 591 million (DKK 703 million)
- The income before interest and tax (EBIT) was a loss of DKK 82 million (income of DKK 2 million).
- As of September 30, 2016 the Group's cash preparedness was DKK 1,647 million (DKK 1,618 million), including unutilized credit lines of DKK 392 million (DKK 384 million).
Revenue generated for the nine months ending September 30, 2016 was DKK 591 million (DKK 703 million, of which revenues from Ebola supply under the Janssen agreement amounted to DKK 519 million). Revenue was composed of DKK 423 million (DKK 0 million) from the sale of IMVAMUNE bulk drug substance to U.S. Government, DKK 13 million (DKK 78 million) from the sale of IMVAMUNE final drug product to other countries, DKK 81 million (DKK 0 million) from the IMVAMUNE holdback, and DKK 75 million (DKK 107 million) from contract work. Revenue reported for the three months ended September 30, 2016 was DKK 452 million (DKK 79 million).
The production costs totaled DKK 192 million (DKK 246 million). Costs related directly to revenue amounted to DKK 134 million (DKK 199 million). Other production costs totaled DKK 58 million (DKK 47 million). In the third quarter of 2016, production costs were DKK 145 million (DKK 44 million).
Research and development costs totaled DKK 324 million (DKK 297 million). The increase is mainly related to the RSV vaccine development program.
Distribution costs totaled DKK 28 million (DKK 33 million) and administrative costs totaled DKK 129 million (DKK 125 million).
The income before interest and tax (EBIT) was a loss of DKK 82 million (income of DKK 2 million).
Financial items totaled a net income of DKK 3 million (net income of DKK 58 million). Net income from securities amounted to DKK 18 million (net expense of DKK 7 million), interest expenses on debt amounted to DKK 3 million (DKK 2 million) and negative exchange rate adjustments amounted to DKK 12 million (positive exchange rate adjustments of DKK 53 million). In 2015 net gain on derivative financial instruments amounted to DKK 14 million.
Income before company tax was a loss of DKK 78 million (income of DKK 60 million).
Tax on income was an income of DKK 22 million (expense of DKK 3 million), corresponding to an effective tax rate of 27.7%.
For the first nine months of 2016, Bavarian Nordic reported a net loss of DKK 57 million (net profit of DKK 57 million), which is in line with the expectations as approximately 40% of the year's revenue is expected to be recognized in the last quarter of 2016.
Inventories have increased by DKK 62 million compared to December 31, 2015. The increase is related to the production of IMVAMUNE bulk drug substance for the U.S. Government.
Trade receivables have increased by DKK 357 million compared to December 31, 2015 as all the revenue related to sale of IMVAMUNE bulk drug substance was recognized in September and outstanding as of September 30, 2016.
Securities, cash and cash equivalents increased by DKK 196 million compared to December 31, 2015 as a result of the private placement in April raising a net proceeds of DKK 626 million.
Prepayment from customers have increased by DKK 56 million compared to December 31, 2015 as the Company received a DKK 61 million upfront payment in January related to the licensing and collaboration agreement entered in December 2015 with Janssen for MVA-BN® in the development of a therapeutic HPV vaccine. As of September 30, 2016 DKK 4 million has been recognized as revenue.
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
As of September 30, 2016 the Group's cash preparedness was DKK 1,647 million (DKK 1,618 million), including unutilized credit lines of DKK 392 million (DKK 384 million). Cash flow spend on operating activities was DKK 374 million (contribution DKK 270 million), since all the IMVAMUNE bulk drug substance revenue recognized in third quarter was outstanding as of September 30, 2016. The high cash contribution in 2015 was due to prepayments received from Janssen related to the Ebola supply agreement and upfront payments from Bristol-Myers Squibb related to the PROSTVAC option agreement. Cash flow spend on investment activities was DKK 417 million (DKK 238 million) primarily due to a net investment in securities of DKK 354 million (DKK 209 million). Cash flow from financing activities contributed with DKK 629 million (DKK 16 million) regarding proceeds from the private placement and warrant exercise. The net change in cash and cash equivalents was DKK -163 million (DKK 48 million).
The Group's equity as of September 30, 2016 stood at DKK 1,915 million (DKK 1,303 million).
Financial Expectations
The Company maintains its 2016 full-year financial expectations with revenue at the level of DKK 1,000 million and a break-even result before interest and tax (EBIT). The cash preparedness at year-end is expected to be approximately DKK 1,900 million (raised from DKK 1,300 million in April after raising DKK 665 million in a private placement). Cash preparedness includes cash, cash equivalents, investments in securities and the aggregate amount of undrawn credit lines.
Total expected research and development costs are approximately DKK 550 million, distributed as shown below.
| Research and development costs to occur | DKK | 550 | million |
|---|---|---|---|
| Of which: | |||
| Contract costs recognized as production costs | DKK | (60) | million |
| Capitalized development costs | DKK | (30) | million |
| DKK | 460 | million | |
| Expensing (amortization) of prior-year costs attributable to the IMVAMUNE development project | DKK | 50 | million |
| Research and development costs to be recognized in the income statement | DKK | 510 | million |
Significant Risks and Uncertainties
Bavarian Nordic faces a number of risks and uncertainties, common for the biotech industry. These relate to operations, research and development, manufacturing, commercial and financial activities. For further information about risks and uncertainties which Bavarian Nordic faces, refer to page 30 "Risk Management" in the 2015 annual report.
Since the publication of the 2015 annual report, the overall risk profile of the Company remains unchanged.
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 3 of 23
Product Pipeline
Our pipeline currently comprises seven product candidates which are subject to multiple ongoing clinical studies in infectious diseases and cancer. Many of our programs are supported by external funding through either private or governmental partnerships.
In addition we have ongoing contracts with the U.S. Government for the preclinical and clinical evaluation of recombinant MVA-BN vaccine candidates for selected biological threats (e.g. filoviruses, foot-and-mouth disease virus, Burkholderia, and Yellow Fever).
Detailed information on our pipeline programs is available in Bavarian Nordic's annual report or on the Company's website: www.bavarian-nordic.com.
| Product | Indication | Status | Commercial Rights |
|---|---|---|---|
| INFECTIOUS DISEASES | |||
| IMVAMUNE liquid-frozen | Smallpox | Approved in Canada and the EU* | Bavarian Nordic |
| IMVAMUNE freeze-dried | Smallpox | Phase 2 | Bavarian Nordic |
| MVA-BN Filo | Ebola/Marburg | Phase 3** | Janssen |
| MVA-BN RSV | Respiratory Syncytial Virus | Phase 2 | Bavarian Nordic |
| MVA-BN HPV | Chronic HPV Infection | Preclinical | Janssen |
| CANCER IMMUNOTHERAPY | |||
| PROSTVAC | Prostate cancer | Phase 3*** | Bristol-Myers Squibb |
| CV301 | Lung cancer (NSCLC) | Phase 1/2 starting in 2016 | Bavarian Nordic |
| MVA-BN Brachyury | Solid Tumors | Phase 1 | Bavarian Nordic |
- Approved in the European Union under the trade name IMVANEX®. Phase 3 ongoing in the U.S.
** Multiple Janssen-sponsored Phase 1, 2 and 3 clinical studies ongoing
*** Multiple NCI-sponsored Phase 2 clinical studies ongoing
IMVAMUNE®
- Non-replicating smallpox vaccine
- Approved in Canada and in the European Union (marketed under the trade name IMVANEX®)
- Available for governments for use under national emergency rules
- 28 million doses delivered to the U.S. Strategic National Stockpile (SNS) to-date
- Next-generation freeze-dried version with longer shelf life in the offing
IMVAMUNE is the only non-replicating smallpox vaccine approved in Europe for use in the general adult population. Although not yet approved in the United States, IMVAMUNE is currently stockpiled by the U.S. Government for emergency use in people for whom replicating smallpox vaccines are contraindicated (e.g. people with HIV and atopic dermatitis). Registration studies are underway to support FDA approval for use of the vaccine in the entire population.
The development of IMVAMUNE has been funded by the U.S. Government, through contracts with the National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (HHS). Contracts awarded to date for the development and supply of the vaccine exceed USD 1.3 billion, including awards to advance MVA-BN as a broad platform for the development of medical countermeasures against other potential biological threats.
Included is also a contract valued at up to USD 95 million to develop a freeze-dried formulation of IMVAMUNE with longer shelf life to fulfil the U.S. Government's long-term stated goal for stockpiling of sufficient non-replicating smallpox vaccine to protect 66 million people, representing 132 million doses of IMVAMUNE.
- A recently published article (Carlin E.P., et. al. (2016), Public Health Nurs.) shows that the potential number of immunocompromised individuals in the U.S., and their household contacts, could potentially represent upward of 120 million people, almost double the at-risk population identified in the U.S. Government goals.
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
As part of the transition to freeze-dried IMVAMUNE, BARDA has ordered bulk supplies of IMVAMUNE in 2015 and 2016 at a total value of USD 233 million. The bulk vaccine will be produced and recognized as revenue over the course of 2016 and 2017. A contract for the eventual delivery of finished product to the U.S. Government is still required prior to determining a dose price of the freeze-dried formulation.
Anticipated developments
- Finalize manufacturing activities to support transition to freeze-dried version.
- Additional orders from U.S.
- Complete enrollment of Phase 3 non-inferiority study to support U.S. approval.
Read more
http://www.bavarian-nordic.com/pipeline/imvamune
MVA-BN RSV
- Respiratory syncytial virus (RSV) vaccine candidate in Phase 2 development
- RSV represents a significant burden in infants and elderly
- Represents large commercial potential as no RSV vaccines are available
MVA-BN RSV is a product candidate in clinical development for the prevention of RSV. The vaccine has been specifically designed to target 5 different RSV proteins to ensure a broad immune response against both RSV subtypes (A & B). Extensive preclinical studies has shown that MVA-BN RSV induces a balanced immune response comprised of both antibodies and T cells, in a similar fashion to the natural response to an RSV infection.
Results from a Phase 1 study were reported in May 2016, demonstrating that MVA-BN RSV was well tolerated and induced a significant boost in antibodies and T cells in humans against both RSV subtypes. Also of note was the production of IgA, a specialized antibody that is transported from the blood to the mucosal surfaces (e.g. nose, throat, lungs) potentially allowing for protection against RSV at the point of infection/inflammation. These results provide a clear rationale for moving into larger trials, and the Company intends to rapidly progress the vaccine candidate into multiple Phase 1 and Phase 2 trials in elderly and at-risk populations, as well as the pediatric population.
Progress report for the third quarter 2016 and up to the reporting date
- In October, the first Phase 2 clinical study of MVA-BN RSV was initiated. The study, which is being conducted in USA, will enroll 400 healthy subjects, aged 55 or older who will be randomized into five groups of 80 subjects each. Subjects will receive one or two administrations four weeks apart of either a low or high dose of MVA-BN RSV or placebo, in order to identify the optimal dose and schedule for future studies.
- In September, the Phase 1 results for MVA-BN RSV in healthy adult subjects were presented at the 10th International Respiratory Syncytial Virus Symposium in Patagonia, Argentina.
Anticipated developments
- Report top-line results from Phase 2 in elderly in 2017
- Initiate a Phase 2b field efficacy study in elderly in 2017.
Read more
http://www.bavarian-nordic.com/pipeline/mva-bn-rsv
MVA-BN Filo
- Ebola and Marburg vaccine candidate in Phase 3 development
- Licensed to Janssen for use in prime-boost vaccine regimens
- 2 million doses produced and delivered as part of Janssen collaboration
MVA-BN Filo is a vaccine candidate, initially developed by Bavarian Nordic in collaboration with NIAID for protection against the filoviruses Ebola and Marburg. In 2014, MVA-BN Filo was licensed to Janssen for use in a prime-boost Ebola vaccine regimen in which a dose of Janssen's Ad26.ZEBOV is first given to prime the immune system, and then a dose of MVA-BN Filo is given at a later date to boost the immune response, with the goal of
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 5 of 23
creating stronger and longer-lasting immunity. Together with an array of consortium partners, Janssen is conducting multiple clinical Phase 1, 2 and 3 trials in healthy adults, children, elderly and immunocompromised populations across Europe, USA and Africa.
Additionally, Janssen has begun investigation of a multivalent prime-boost regimen which also employs MVA-BN Filo as booster with Ad26.Filo, with the goal of creating a vaccine that offers protection against multiple filoviruses that cause disease in humans, including the Ebola, Sudan and Marburg viruses.
Progress report for the third quarter 2016 and up to the reporting date
- In September, Janssen completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for the Ebola prime-boost vaccine regimen. The EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of treatment or prevention options. EUAL assists UN Member States and procurement agencies determine the acceptability for use of a specific vaccine in a public health emergency. The decision to grant EUAL to the investigational vaccine regimen will be based on an evaluation of available data including quality, safety, and immunogenicity, as well as a risk/benefit analysis. While EUAL potentially allows for deployment of a vaccine in an emergency, the vaccine remains investigational pending formal regulatory agency review and approval.
- In September, Janssen furthermore initiated a first-in-human Phase 1 clinical study to test a second-generation, multivalent version of the AdVac/MVA-BN vaccine regimen. The multivalent heterologous prime-boost regimen is intended to protect against multiple filoviruses, including the Ebola Zaire, Ebola Sudan and Marburg viruses. The U.S. study will test the safety, tolerability and immunogenicity of this vaccine regimen in varying dosing schedules among healthy volunteers. The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), is funding this study.
Anticipated developments
- Report results of ongoing clinical studies of the prime-boost vaccine (Janssen).
Read more
http://www.bavarian-nordic.com/pipeline/mva-bn-filo
MVA-BN HPV
- Human papillomavirus (HPV) vaccine candidate
- Preclinical stage program in collaboration with Janssen
- Novel approach for early treatment and interception of HPV-induced cancers
MVA-BN HPV is a new vaccine candidate, which was licensed to Janssen in December 2015 as the first of three potential infectious disease indications. MVA-BN HPV will be developed for use together with Janssen's adenovirus vector based technology in a prime-boost vaccine regimen targeting HPV. The long-term goal is to develop a vaccine to treat chronic HPV infections as well as prevent precancerous stages of HPV-induced cancer.
Janssen continues to retain an exclusive option to license MVA-BN for the two additional undisclosed infectious disease targets.
Anticipated developments
- Initiate a Phase 1 clinical study in 2017
PROSTVAC
- Prostate cancer immunotherapy candidate
- Collaboration with Bristol-Myers Squibb
- Demonstrated overall survival benefit in Phase 2 clinical study in patients with late-stage prostate cancer
- Potential for use in earlier disease stages and in combination with other anti-cancer agents
- Phase 3 ongoing with final data readout anticipated in 2017
PROSTVAC is a prostate specific antigen (PSA)-targeted immunotherapy candidate designed to enhance or stimulate the body's immune response, specifically T cells that will home to and kill prostate cancer cells,
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 6 of 23
altering the course of the disease and improving overall survival of patients with prostate cancer. PROSTVAC employs two poxviruses (vaccinia and fowlpox) in a prime-boost vaccine regimen. A robust data package has been established that includes 18 ongoing or completed clinical studies, comprising more than 2,000 patients, the majority of which have been actively treated with PROSTVAC, which has been generally well-tolerated.
PROSTVAC is being developed under a cooperative research and development agreement (CRADA) with the U.S. National Cancer Institute (NCI). An agreement was entered with Bristol-Myers Squibb in March 2015, providing them an exclusive option to license and commercialize PROSTVAC.
The PROSPECT study
PROSTVAC is currently the subject of a global randomized, double-blind, placebo-controlled Phase 3 trial (PROSPECT) in 1,297 patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
The primary objective of the trial is to determine whether the overall survival (OS) of patients receiving PROSTVAC in either of the treatment arms, with or without the addition of granulocyte macrophage colony-stimulating factor (GM-CSF), is superior to that of patients receiving placebo. While the prior placebo-controlled Phase 2 trial included the use of GM-CSF, additional clinical work has shown that it may not be required, and therefore the Phase 3 trial has been designed to potentially rule out the need for GM-CSF.
The study was fully enrolled in January 2015. While the recruitment of patients occurred primarily between 2012 and 2014, it is worth noting that the recruitment rate was higher toward the latter half of the study, as is common. Based on this rate, the Company anticipates that final OS analysis will occur in 2017.
Final analysis requires 534 events (deaths) in each comparison of the two treatment arms versus placebo. For the study outcome to be positive, a hazard ratio of 0.82 or less is required. The study has a power of $85\%$ and is designed to detect a difference in survival between active treatment and placebo at final analysis. However, three pre-specified interim analyses of data have been integrated into the statistical plan to evaluate whether the trial should continue as planned or potentially be stopped early for efficacy or futility. The efficacy and futility hurdles for these interim analysis are, what the Company considers to be, high, and it is the Company's continued belief that the study will continue to the final OS analysis. The first two interim analyses occurred at 214 and 321 events respectively, both confirming that the study should continue without modification as recommended by the independent Data Monitoring Committee (DMC). The third interim analysis will occur at 427 events. The company remains blinded to all data.
Exploring the full potential of PROSTVAC in combination trials
To leverage the full potential of PROSTVAC, Bavarian Nordic and its partners are conducting exploratory combination studies of PROSTVAC with or without agents from Bristol-Myers Squibb's immuno-oncology portfolio, including ipilimumab (Yervoy®) and nivolumab (Opdivo®). These studies will investigate the potential synergies of combining PROSTVAC with one or more checkpoint inhibitors in early stages of prostate cancer. In addition to a series of planned, ongoing and completed NCI-sponsored studies of PROSTVAC as single or combination therapy, these studies will add to the clinical experience, thus potentially broadening the future commercial value of PROSTVAC.
Ongoing and planned PROSTVAC studies:
| Therapy | Indication | Details | Status |
|---|---|---|---|
| PROSTVAC | Localized prostate cancer Patients undergoing active surveillance | Phase 2 150 patients | Enrolling |
| PROSTVAC | Localized prostate cancer, neoadjuvant Patients undergoing radical prostatectomy | Phase 2 27 patients | Fully enrolled |
| PROSTVAC + ipilimumab | Localized prostate cancer, neoadjuvant Patients undergoing radical prostatectomy | Phase 2 75 patients | Enrolling |
| PROSTVAC + ipilimumab + nivolumab | Localized prostate cancer, neoadjuvant Patients undergoing radical prostatectomy | Phase 2 65 patients | Planned |
| PROSTVAC | Patients at risk of relapse after radical prostatectomy | Phase 2 44 patients | Enrolling |
| PROSTVAC + flutamide | Non-metastatic prostate cancer | Phase 2 53 patients | Fully enrolled |
| PROSTVAC | Non-metastatic castration sensitive prostate cancer | Phase 2 80 patients | Enrolling |
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 8 of 23
| PROSTVAC
+ enzalutamide | Non-metastatic castration sensitive prostate cancer | Phase 2
38 patients | Fully enrolled |
| --- | --- | --- | --- |
| PROSTVAC
+ docetaxel + ADT | Metastatic castration sensitive prostate cancer | Phase 2
38 patients | Enrolling |
| PROSTVAC
+ enzalutamide | mCRPC | Phase 2
76 patients | Enrolling |
| PROSTVAC | mCRPC | Phase 3
1,297 patients | Fully enrolled |
Progress report for the third quarter 2016 and up to the reporting date
- In October, a Phase 2 clinical trial of PROSTVAC in combination treatment with ipilimumab as neoadjuvant therapy in 75 patients with localized prostate cancer was initiated. Patients are being randomized into three cohorts of 25 each to receive either PROSTVAC or ipilimumab or a combination of both. The primary endpoint of the study is to evaluate CD3+ T cell immune responses and secondary measures include immunologic infiltration, circulating effector T cells and regulatory T cells. The principal investigator of the study is Lawrence Fong, MD, Professor, Department of Medicine (Hematology/Oncology), University of California, San Francisco (UCSF) and UCSF is also sponsor of the study.
- After review of the second interim analysis of the PROSTVAC Phase 3 study in July, the Data Monitoring Committee informed Bavarian Nordic that the trial should continue without modification as planned.
Anticipated developments
- Initiate NCI-sponsored Phase 2 combination study of PROSTVAC, ipilimumab and nivolumab
- Phase 3 third interim analysis
- Phase 3 top-line data (2017)
- Report results from ongoing NCI-sponsored Phase 2 clinical trials.
Read more
http://www.bavarian-nordic.com/pipeline/prostvac
CV301
- Immunotherapy candidate for multiple cancers
- Collaboration with NCI
- Phase 1/2 trial in non-small cell lung cancer planned for initiation in 2016
CV301 targets two tumor-associated antigens, CEA and MUC-1, which are over-expressed in major cancer types, including lung, bladder and colorectal cancer. Similar to PROSTVAC, CV301 uses a prime/boost dosing schedule with MVA-BN as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules. A precursor version of CV301 has been tested in six NCI-sponsored clinical trials in various cancers, and a Phase 2 study in bladder cancer is currently ongoing. More than 300 patients have been treated with the product candidate.
As part of a refocused strategy towards developing CV301 as combination treatment with checkpoint inhibitors, a clinical trial in combining CV301 with OPDIVO® (nivolumab) from Bristol-Myers Squibb will begin in the fall of 2016. The study will enroll patients with non-small cell lung cancer (NSCLC) who have failed prior therapy.
The trial will begin with a Phase 1 safety component, enrolling up to 40 patients; the Phase 2 portion of the study will enroll 120 patients who will be randomized to receive either nivolumab (monotherapy) or a combination of CV301 and nivolumab. The study will enroll patients from up to 20 clinical sites throughout the United States. Detailed information on the trial can be found at http://clinicaltrials.gov/ct2/show/NCT02840994.
While the primary endpoint of the study is overall survival, numerous secondary endpoints including response rate, progression free survival and duration of response will be evaluated and offer the potential for an early efficacy signal, prior to an overall survival endpoint.
While NSCLC represents the first clinical target, additional Phase 2 trials are planned for evaluating CV301 in combination with checkpoint inhibitors. Both bladder cancer and colorectal cancer are currently under evaluation as potential indications.
Progress report for the third quarter 2016 and up to the reporting date
- In August, Bavarian Nordic entered a drug supply agreement with Bristol-Myers Squibb, providing nivolumab for the upcoming clinical trial of CV301 as combination therapy in non-small cell lung cancer.
Anticipated developments
- Initiate a Phase 2 study of CV301 in combination with checkpoint inhibitors in NSCLC and additional indications
Read more
http://www.bavarian-nordic.com/pipeline/cv-301
MVA-BN Brachyury
- Immunotherapy candidate for the treatment of metastatic cancer and chordoma
- Clinical development sponsored by the National Cancer Institute (NCI)
MVA-BN Brachyury is designed to induce a robust T-cell immune response against brachyury, a tumor-associated antigen that is overexpressed in major solid tumor indications. Brachyury is reported to play a key role in the metastasis and progression of tumors. Tumors that overexpress brachyury are believed to be highly resistant to current therapies and are associated with decreased survival rates.
Results from a Phase 1 trial of MVA-BN Brachyury in 38 patients with metastatic cancer or chordoma were reported in November 2015, and demonstrate for the first time that an MVA-BN based vaccine targeting brachyury can induce brachyury-specific T-cell immune responses in advanced cancer patients.
Anticipated developments
- Initiate NCI-sponsored Phase 2 study of MVA-BN Brachyury.
Read more
http://www.bavarian-nordic.com/pipeline/mva-bn-brachyury
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 9 of 23
Other Developments
Christopher R. Heery, M.D. appointed Chief Medical Officer
In September, Christopher R. Heery, M.D. was appointed Chief Medical Officer of Bavarian Nordic. In this role, Dr. Heery will oversee the clinical development of the Company's infectious disease and immuno-oncology portfolio. In conjunction with the hiring of Dr. Heery, a new office will be established on the U.S. east coast. This will position the Company's U.S. operations where most of Bavarian Nordic's collaboration partners are located. The current operations in Redwood City, CA will relocate to the new offices.
Most recently, Dr. Heery was Director of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute (NCI). He joined the NCI Medical Oncology Branch as a Medical Oncology Fellow in 2009 and also served as an Adjunct Appointment in the Genitourinary Malignancies Branch. He was also part of the larger effort of the Laboratory of Tumor Immunology and Biology to create new immunotherapies for the treatment of cancer.
Dr. Heery is board certified in Medical Oncology and Internal Medicine and received his M.D. from East Carolina University Brody School of Medicine in 2006. He completed his internal medicine residency at the University of Illinois at Chicago in 2009. Dr. Heery received his undergraduate degree from Duke University.
Dr. Heery will report to Paul Chaplin, CEO, however his appointment does not change the current composition of Bavarian's Nordic Executive Management.
Share Information
Bavarian Nordic is listed on the Nasdaq Copenhagen exchange under the symbol BAVA. Furthermore, Bavarian Nordic has established a sponsored Level 1 American Depositary Receipt (ADR) program in the U.S. Bavarian Nordic ADRs are available for trading in the U.S. over-the-counter (OTC) market under the symbol BVNRY. Three ADRs represent one Bavarian Nordic share.
Developments in the share capital
In March, the Company issued 46,041 new shares as a consequence of employees' exercise of warrants. The shares were subscribed for in cash at the following prices per share of nominally DKK 10: 6,041 shares at DKK 54.00 and 40,000 shares at DKK 55.00. The total proceeds to Bavarian Nordic amounted to DKK 2.5 million.
In April, the Company announced and completed a private placement of 2,770,000 new shares through an accelerated book-building process. The subscription price was DKK 240 per share of nominal value DKK 10 each, raising gross proceeds to Bavarian Nordic of approximately DKK 665 million.
In May, the Company issued 92,500 new shares as a consequence of employees' exercise of warrants. The shares were subscribed for in cash at the following prices per share of nominally DKK 10: 10,000 shares at DKK 54.10 and 82,500 shares at DKK 59.10. The total proceeds to Bavarian Nordic amounted to DKK 5.4 million.
In August, the Company issued 5,848 new shares as a consequence of employees' exercise of warrants. The shares were subscribed for in cash at DKK 54.00 per share of nominally DKK 10: The total proceeds to Bavarian Nordic amounted to DKK 0.3 million.
Consequently, at September 30, 2016, the Company's share capital amounts to DKK 309,340,600, which is made up of 30,934,060 shares with a nominal value of DKK 10 each. There were 1,469,216 outstanding warrants, which entitle warrant holders to subscribe for 1,469,216 shares with a nominal value of DKK 10 each. Thus the fully diluted share capital amounted to DKK 32,403,276 at September 30, 2016.
Financial calendar 2017
March 15, 2017
2016 Annual Report
April 25, 2017
Annual General Meeting
Shareholders who wish to submit a request for proposals for consideration at the Annual General Meeting must lodge this with the Company no later than Wednesday, March 15, 2017.
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
May 4, 2017
First quarterly report (Q1) for the three-month period ended 31 March 2017
August 25, 2017
Half-year report (Q2) for the six-month period ended 30 June 2017
November 8, 2017
Third quarterly report (Q3) for the nine-month period ended 30 September 2017
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 11 of 23
Statement from the Board of Directors and Corporate Management
The Board of Directors and Corporate Management have, today reviewed and approved the Bavarian Nordic A/S interim report for the period January 1 to September 30, 2016.
The interim report has been prepared in accordance with IAS 34 "Interim Financial Reporting" as adopted by the EU and additional Danish disclosure requirements for interim reports of listed companies, including those of Nasdaq Copenhagen.
In our opinion, the interim report gives a true and fair view of the group's assets and liabilities and financial position as of September 30, 2016 and the results of the group's activities and cash flows for the period January 1 to September 30, 2016.
In our opinion, the management's review provides a true and fair description of the development in the group's activities and financial affairs, the results for the period and the group's financial position as a whole as well as a description of the most important risks and uncertainty factors faced by the group.
Kvistgaard, November 9, 2016
Corporate Management:
Paul Chaplin
President and CEO
Ole Larsen
Executive Vice President & CFO
Board of Directors:
Gerard van Odijk
Chairman of the Board
Anders Gersel Pedersen
Deputy Chairman
Claus Bræstrup
Erik G. Hansen
Peter Kürstein
Frank Verwiel
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Financial Statements
Consolidated Key Figures (unaudited)
| DKK thousand | 1/7 - 30/9 2016 | 1/7 - 30/9 2015 | 1/1 - 30/9 2016 | 1/1 - 30/9 2015 | 1/1-31/12 2015 |
|---|---|---|---|---|---|
| Income statements | |||||
| Revenue | 452,297 | 79,100 | 591,412 | 703,015 | 1,020,561 |
| Production costs | 145,097 | 43,542 | 192,304 | 245,678 | 415,138 |
| Research and development costs | 130,990 | 77,663 | 324,426 | 296,848 | 386,811 |
| Distribution costs | 9,391 | 5,573 | 28,088 | 32,998 | 42,272 |
| Administrative costs | 41,985 | 34,851 | 128,547 | 125,249 | 174,786 |
| Income before interest and taxes (EBIT) | 124,834 | (82,529) | (81,953) | 2,242 | 1,554 |
| Financial items, net | 1,076 | (4,518) | 3,456 | 58,225 | 76,075 |
| Income before company tax | 125,910 | (87,047) | (78,497) | 60,467 | 77,629 |
| Net profit for the period | 97,818 | (49,625) | (56,717) | 57,111 | 59,426 |
| Balance sheet | |||||
| Total non-current assets | 584,413 | 552,743 | 585,005 | ||
| Total current assets | 1,998,508 | 1,586,396 | 1,404,258 | ||
| Total assets | 2,582,921 | 2,139,139 | 1,989,263 | ||
| Equity | 1,914,596 | 1,302,663 | 1,342,479 | ||
| Non-current liabilities | 55,605 | 49,873 | 56,550 | ||
| Current liabilities | 612,720 | 786,603 | 590,234 | ||
| Cash flow statements | |||||
| Securities, cash and cash equivalents | 1,254,523 | 1,233,914 | 1,058,204 | ||
| Cash flow from operating activities | (374,085) | 269,969 | 105,323 | ||
| Cash flow from investment activities | (417,496) | (238,467) | (178,123) | ||
| - Investment in intangible assets | (34,951) | (16,930) | (28,269) | ||
| - Investment in property, plant and equipment | (27,920) | (12,620) | (31,652) | ||
| Cash flow from financing activities | 628,864 | 16,319 | 26,569 | ||
| Financial Ratios (DKK) 1) | |||||
| Earnings (basic) per share of DKK 10 | (1.9) | 2.1 | 2.1 | ||
| Net asset value per share | 61.9 | 46.8 | 47.9 | ||
| Share price at period-end | 250 | 264 | 358 | ||
| Share price/Net asset value per share | 4.0 | 5.6 | 7.5 | ||
| Number of outstanding shares at period-end | 30,934 | 27,834 | 28,020 | ||
| Equity share | 74% | 61% | 67% | ||
| Number of employees, converted to full-time, at period-end | 437 | 408 | 409 |
1) Earnings per share (EPS) is calculated in accordance with IAS 33 "Earning per share". The financial ratios have been calculated in accordance with "Anbefalinger og Nøgletal 2015" (Recommendations and Financial ratios 2015).
Notes
(stated in the end of this document):
- Significant accounting policies
- Significant accounting estimates, assumptions and uncertainties
- Revenue
- Production costs
- Research and development costs
- Financial income
- Financial expenses
- Inventories
- Other receivables
- Prepayment from customers
- Other liabilities
- Financial instruments
- Incentive plans
- Significant changes in contingent liabilities and other contractual obligations
- Significant events after the balance sheet date
- Approval of the unaudited condensed consolidated interim financial statements
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Unaudited Condensed Consolidated Income Statements for the Periods Ended September 30, 2016 and 2015
| DKK thousand | Note | 1/7 - 30/9 2016 | 1/7 - 30/9 2015 | 1/1 - 30/9 2016 | 1/1 - 30/9 2015 | 1/1-31/12 2015 |
|---|---|---|---|---|---|---|
| Revenue | 3 | 452,297 | 79,100 | 591,412 | 703,015 | 1,020,561 |
| Production costs | 4 | 145,097 | 43,542 | 192,304 | 245,678 | 415,138 |
| Gross profit | 307,200 | 35,558 | 399,108 | 457,337 | 605,423 | |
| Research and development costs | 5 | 130,990 | 77,663 | 324,426 | 296,848 | 386,811 |
| Distribution costs | 9,391 | 5,573 | 28,088 | 32,998 | 42,272 | |
| Administrative costs | 41,985 | 34,851 | 128,547 | 125,249 | 174,786 | |
| Total operating costs | 182,366 | 118,087 | 481,061 | 455,095 | 603,869 | |
| Income before interest and tax (EBIT) | 124,834 | (82,529) | (81,953) | 2,242 | 1,554 | |
| Financial income | 6 | 4,624 | 2,941 | 18,566 | 78,853 | 99,357 |
| Financial expenses | 7 | 3,548 | 7,459 | 15,110 | 20,628 | 23,282 |
| Income before company tax | 125,910 | (87,047) | (78,497) | 60,467 | 77,629 | |
| Tax on income for the period | 28,092 | (37,422) | (21,780) | 3,356 | 18,203 | |
| Net profit for the period | 97,818 | (49,625) | (56,717) | 57,111 | 59,426 | |
| Earnings per share (EPS) - DKK | ||||||
| Basic earnings per share of DKK 10 | 3.3 | (1.8) | (1.9) | 2.1 | 2.1 | |
| Diluted earnings per share of DKK 10 | 3.2 | (1.8) | (1.9) | 2.1 | 2.1 |
Unaudited Condensed Consolidated Statements of Comprehensive Income for the Periods Ended September 30, 2016 and 2015
| DKK thousand | 1/7 - 30/9 2016 | 1/7 - 30/9 2015 | 1/1 - 30/9 2016 | 1/1 - 30/9 2015 | 1/1-31/12 2015 |
|---|---|---|---|---|---|
| Net profit for the period | 97,818 | (49,625) | (56,717) | 57,111 | 59,426 |
| Items that might be reclassified to the income statement: | |||||
| Exchange rate adjustments on translating foreign operations | 1,509 | 449 | 7,558 | (32,152) | (38,371) |
| Fair value of financial instruments entered into to hedge future cash flow: | |||||
| Fair value adjustment for the period | (15) | - | (5,382) | - | - |
| Fair value adjustment transferred to revenue | 4,667 | - | 4,667 | - | - |
| Fair value adjustment transferred to financial items | (701) | (701) | |||
| Tax on other comprehensive income | (869) | - | 312 | - | - |
| Other comprehensive income after tax | 4,591 | 449 | 6,454 | (32,152) | (38,371) |
| Total comprehensive income | 102,409 | (49,176) | (50,263) | 24,959 | 21,055 |
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 14 of 23
Unaudited Condensed Consolidated Statements of Financial Position - Assets as of September 30, 2016 and 2015 and December 31, 2015
| DKK thousand | Note | 30/9 2016 | 30/9 2015 | 31/12 2015 |
|---|---|---|---|---|
| Assets | ||||
| Software | 5,807 | 3,740 | 3,194 | |
| IMVAMUNE development project | 83,555 | 90,882 | 100,500 | |
| Intangible assets in progress | 13,736 | 2,245 | 4,495 | |
| Intangible assets | 103,098 | 96,867 | 108,189 | |
| Land and buildings | 206,579 | 217,015 | 218,610 | |
| Leasehold improvements | 756 | 678 | 402 | |
| Plant and machinery | 60,137 | 58,214 | 53,562 | |
| Fixtures and fittings, other plant and equipment | 18,463 | 17,878 | 19,358 | |
| Assets under construction | 36,577 | 24,912 | 33,828 | |
| Property, plant and equipment | 322,512 | 318,697 | 325,760 | |
| Other receivables | 1,069 | 892 | 914 | |
| Financial assets | 1,069 | 892 | 914 | |
| Deferred tax assets | 157,734 | 136,287 | 150,142 | |
| Total non-current assets | 584,413 | 552,743 | 585,005 | |
| Development projects for sale | 70,069 | 66,843 | 70,069 | |
| Inventories | 8 | 153,397 | 154,113 | 91,002 |
| Trade receivables | 495,253 | 88,900 | 137,927 | |
| Tax receivables | - | 4,499 | 4,174 | |
| Other receivables | 9 | 18,760 | 13,519 | 19,652 |
| Prepayments | 6,506 | 24,608 | 23,230 | |
| Receivables | 520,519 | 131,526 | 184,983 | |
| Securities | 1,045,190 | 771,569 | 684,141 | |
| Cash and cash equivalents | 209,333 | 462,345 | 374,063 | |
| Securities, cash and cash equivalents | 1,254,523 | 1,233,914 | 1,058,204 | |
| Total current assets | 1,998,508 | 1,586,396 | 1,404,258 | |
| Total assets | 2,582,921 | 2,139,139 | 1,989,263 |
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 15 of 23
Unaudited Condensed Consolidated Statements of Financial Position - Equity and Liabilities as of September 30, 2016 and 2015 and December 31, 2015
| DKK thousand | Note | 30/9 2016 | 30/9 2015 | 31/12 2015 |
|---|---|---|---|---|
| Equity and liabilities | ||||
| Share capital | 309,341 | 278,344 | 280,197 | |
| Treasury shares | (111) | - | - | |
| Retained earnings | 1,615,055 | 1,052,132 | 1,066,558 | |
| Other reserves | (9,689) | (27,813) | (4,276) | |
| Equity | 1,914,596 | 1,302,663 | 1,342,479 | |
| Provisions | 25,226 | 18,057 | 25,226 | |
| Debt to credit institutions | 30,379 | 31,816 | 31,324 | |
| Non-current liabilities | 55,605 | 49,873 | 56,550 | |
| Debt to credit institutions | 2,136 | 1,956 | 1,969 | |
| Prepayment from customers | 10 | 461,536 | 613,116 | 405,789 |
| Trade payables | 45,909 | 51,557 | 69,574 | |
| Company tax | 1,178 | 43 | 621 | |
| Provisions | - | 2,471 | 570 | |
| Other liabilities | 11 | 101,961 | 117,460 | 111,711 |
| Current liabilities | 612,720 | 786,603 | 590,234 | |
| Total liabilities | 668,325 | 836,476 | 646,784 | |
| Total equity and liabilities | 2,582,921 | 2,139,139 | 1,989,263 |
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 16 of 23
Unaudited Condensed Consolidated Statements of Cash Flow for the Periods Ended September 30, 2016 and 2015 and December 31, 2015
| DKK thousand | 1/1 - 30/9 2016 | 1/1 - 30/9 2015 | 1/1-31/12 2015 |
|---|---|---|---|
| Net profit for the period | (56,717) | 57,111 | 59,426 |
| Adjustment for non-cash items: | |||
| Financial income | (18,566) | (78,853) | (99,357) |
| Financial expenses | 15,110 | 20,628 | 23,282 |
| Tax on income for the period | (21,780) | 3,356 | 18,203 |
| Depreciation, amortization and impairment losses | 32,833 | 32,651 | 43,525 |
| Expensing (amortization) of IMVAMUNE development project | 38,331 | 2,692 | 2,694 |
| Share-based payment | 12,248 | 15,712 | 26,746 |
| Changes in development projects for sale | - | (39,918) | (41,656) |
| Changes in inventories | (62,395) | (32,266) | 30,845 |
| Changes in receivables | (335,569) | 49,532 | 28,017 |
| Changes in provisions | (570) | (2,140) | (878) |
| Changes in current liabilities | 34,577 | 229,004 | (12,470) |
| Cash flow from operations (operating activities) | (362,498) | 257,509 | 78,377 |
| Received financial income | 11,652 | 32,255 | 43,742 |
| Paid financial expenses | (18,772) | (2,181) | (2,935) |
| Paid company taxes | (4,467) | (17,614) | (13,861) |
| Cash flow from operating activities | (374,085) | 269,969 | 105,323 |
| Investments in and additions to intangible assets | (34,951) | (16,930) | (28,269) |
| Investments in property, plant and equipment | (27,920) | (12,620) | (31,652) |
| Disposal of property, plant and equipment | - | - | 1,200 |
| Investments in/disposal of financial assets | (155) | (100) | (122) |
| Investments in securities | (597,429) | (616,279) | (734,557) |
| Disposal of securities | 242,959 | 407,462 | 615,277 |
| Cash flow from investment activities | (417,496) | (238,467) | (178,123) |
| Payment on mortgage and construction loan | (33,824) | (1,406) | (1,885) |
| Proceeds from mortgage loan | 32,515 | - | - |
| Proceeds from warrant programs exercised | 8,259 | 17,821 | 28,595 |
| Proceeds from private placement | 664,800 | - | - |
| Cost related to issue of new shares | (40,037) | (96) | (141) |
| Purchase of treasury shares | (2,849) | - | - |
| Cash flow from financing activities | 628,864 | 16,319 | 26,569 |
| Cash flow of the period | (162,717) | 47,821 | (46,231) |
| Cash as of 1 January | 374,063 | 398,357 | 398,357 |
| Currency adjustments 1 January | (2,013) | 16,167 | 21,937 |
| Cash end of period | 209,333 | 462,345 | 374,063 |
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 17 of 23
Unaudited Condensed Consolidated Statements of Changes in Equity for the Periods Ended September 30, 2016 and 2015
| DKK thousand | Share capital | Treasury shares | Retained earnings | Reserves for currency adjustment | Reserves for fair value of financial instruments | Share-based payment | Equity |
|---|---|---|---|---|---|---|---|
| Equity as of January 1, 2016 | 280,197 | - | 1,066,558 | (73,556) | - | 69,280 | 1,342,479 |
| Comprehensive income for the period | |||||||
| Net profit | - | - | (56,717) | - | - | - | (56,717) |
| Other comprehensive income | |||||||
| Exchange rate adjustments on translating foreign operations | - | - | - | 7,558 | - | - | 7,558 |
| Fair value of financial instruments | - | - | - | - | (1,104) | - | (1,104) |
| Total comprehensive income for the period | - | - | (56,717) | 7,558 | (1,104) | - | (50,263) |
| Transactions with owners | |||||||
| Share-based payment | - | - | - | - | - | 15,863 | 15,863 |
| Warrant program exercised | 1,444 | - | 8,761 | - | - | (1,946) | 8,259 |
| Warrant program expired | - | - | 120 | - | - | (120) | - |
| Capital increase through private placement | 27,700 | - | 637,100 | - | - | - | 664,800 |
| Cost related to issue of new shares | - | - | (40,037) | - | - | - | (40,037) |
| Purchase of treasury shares | - | (111) | (730) | - | - | (2,008) | (2,849) |
| Tax related to items recognized directly in equity | - | - | - | - | - | (23,656) | (23,656) |
| Total transactions with owners | 29,144 | (111) | 605,214 | - | - | (11,867) | 622,380 |
| Equity as of September 30, 2016 | 309,341 | (111) | 1,615,055 | (65,998) | (1,104) | 57,413 | 1,914,596 |
| DKK thousand | Share capital | Treasury shares | Retained earnings | Reserves for currency adjustment | Reserves for fair value of financial instruments | Share-based payment | Equity |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Equity as of January 1, 2015 | 276,712 | - | 972,321 | (35,185) | - | 38,246 | 1,252,094 |
| Comprehensive income for the period | |||||||
| Net profit | - | - | 57,111 | - | - | - | 57,111 |
| Other comprehensive income | |||||||
| Exchange rate adjustments on translating foreign operations | - | - | - | (32,152) | - | - | (32,152) |
| Total comprehensive income for the period | - | - | 57,111 | (32,152) | - | - | 24,959 |
| Transactions with owners | |||||||
| Share-based payment | - | - | - | - | - | 7,885 | 7,885 |
| Warrant program exercised | 1,631 | - | 22,661 | - | - | (6,471) | 17,821 |
| Warrant program expired | - | - | 136 | - | - | (136) | - |
| Cost related to issue of new shares | - | - | (96) | - | - | - | (96) |
| Total transactions with owners | 1,631 | - | 22,701 | - | - | 1,278 | 25,610 |
| Equity as of September 30, 2015 | 278,343 | - | 1,052,133 | (67,337) | - | 39,524 | 1,302,663 |
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 18 of 23
Notes
1. Significant accounting policies
The interim financial statements are prepared in accordance with IAS 34, Interim Financial Reporting, as adopted by EU and the additional Danish requirements for submission of interim reports for companies listed on Nasdaq Copenhagen. The interim report has not been audited or reviewed by the company's auditors.
The interim financial statements are presented in Danish Kroner (DKK), which is considered the primary currency of the Group's activities and the functional currency of the parent company.
The accounting policies used in the interim financial statements are consistent with those used in the consolidated financial statements for 2015 and in accordance with the recognition and measurement policies in the International Financial Reporting Standards (IFRS) as adopted by EU.
2. Significant accounting estimates, assumptions and uncertainties
In the preparation of the interim financial statements according to IAS 34, Interim Financial Reporting, as adopted by the EU, Management is required to make certain estimates as many financial statement items cannot be reliably measured, but must be estimated. Such estimates comprise judgments made on the basis of the most recent information available at the reporting date. It may be necessary to change previous estimates as a result of changes to the assumptions on which the estimates were based or due to supplementary information, additional experience or subsequent events.
Similarly, the value of assets and liabilities often depends on future events that are somewhat uncertain. In that connection, it is necessary to set out e.g. a course of events that reflects Management's assessment of the most probable course of events.
Further to the significant accounting estimates, assumptions and uncertainties, which are stated in the Annual Report 2015, the Management has not changed significant estimates and judgments regarding recognition and measurement.
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 19 of 23
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 20 of 23
| DKK thousand | 1/7 - 30/9 2016 | 1/7 - 30/9 2015 | 1/1 - 30/9 2016 | 1/1 - 30/9 2015 | 1/1-31/12 2015 |
|---|---|---|---|---|---|
| 3. Revenue | |||||
| IMVAMUNE sale | 423,113 | 170 | 435,896 | 77,592 | 77,813 |
| Other product sale | - | 17,608 | - | 518,908 | 762,054 |
| Sale of goods | 423,113 | 17,778 | 435,896 | 596,500 | 839,867 |
| IMVAMUNE sale, development results | - | - | 80,746 | - | - |
| Contract work | 29,184 | 61,322 | 74,770 | 106,515 | 180,694 |
| Sale of services | 29,184 | 61,322 | 155,516 | 106,515 | 180,694 |
| Revenue | 452,297 | 79,100 | 591,412 | 703,015 | 1,020,561 |
| Total revenue includes: | |||||
| Fair value adjustment transferred from other comprehensive income concerning financial instruments entered into to hedge USD revenue from IMVAMUNE sale | - | - | (4,667) | - | - |
| 4. Production costs | |||||
| Cost of goods sold, IMVAMUNE sale | 92,627 | 14 | 94,428 | 20,497 | 20,511 |
| Cost of goods sold, other product sale | - | 3,532 | - | 122,829 | 171,209 |
| Contract costs | 12,533 | 27,975 | 39,850 | 55,680 | 108,678 |
| Other production costs | 39,937 | 12,021 | 58,026 | 46,672 | 114,740 |
| Production costs | 145,097 | 43,542 | 192,304 | 245,678 | 415,138 |
| 5. Research and development costs | |||||
| Research and development costs occured in the period | 112,602 | 108,098 | 347,330 | 365,053 | 517,632 |
| Of which: | |||||
| Contract costs recognized as production costs | (12,533) | (27,975) | (39,850) | (55,680) | (108,678) |
| Capitalized development costs | (7,229) | (2,640) | (21,385) | (15,217) | (24,837) |
| 92,840 | 77,483 | 286,095 | 294,156 | 384,117 | |
| Expensing (amortization) of prior-year costs attributable to the IMVAMUNE development project | 38,150 | 180 | 38,331 | 2,692 | 2,694 |
| Research and development costs | 130,990 | 77,663 | 324,426 | 296,848 | 386,811 |
| 6. Financial income | |||||
| Interest income | 20 | - | 272 | - | 38 |
| Interest income from financial assets not measured at fair value in the income statement | 20 | - | 272 | - | 38 |
| Financial income from securities | 4,264 | 4,172 | 11,278 | 11,423 | 14,959 |
| Fair value adjustments on securities | (361) | - | 6,315 | - | - |
| Net gains on derivative financial instruments at fair value in the income statement | 701 | (757) | 701 | 14,577 | 17,402 |
| Net foreign exchange gains | - | (474) | - | 52,853 | 66,958 |
| Financial income | 4,624 | 2,941 | 18,566 | 78,853 | 99,357 |
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 21 of 23
| DKK thousand | 1/7 - 30/9 2016 | 1/7 - 30/9 2015 | 1/1 - 30/9 2016 | 1/1 - 30/9 2015 | 1/1-31/12 2015 |
|---|---|---|---|---|---|
| 7. Financial expenses | |||||
| Interest expenses on debt | 1,401 | 577 | 2,709 | 1,999 | 2,676 |
| Interest expenses on financial liabilities not measured at fair value in the income statement | 1,401 | 577 | 2,709 | 1,999 | 2,676 |
| Fair value adjustments on securities | - | 7,031 | - | 18,778 | 16,749 |
| Adjustment of net present value of provisions | - | (149) | - | (149) | 3,857 |
| Net foreign exchange losses | 2,147 | - | 12,401 | - | - |
| Financial expenses | 3,548 | 7,459 | 15,110 | 20,628 | 23,282 |
| DKK thousand | 30/9 2016 | 30/9 2015 | 31/12 2015 | ||
| 8. Inventories | |||||
| Raw materials and supply materials | 38,481 | 29,122 | 31,785 | ||
| Work in progress | 208,140 | 168,648 | 135,589 | ||
| Manufactured goods and commodities | 10,900 | 14,011 | 13,517 | ||
| Write-down on inventory | (104,124) | (57,668) | (89,889) | ||
| Inventories | 153,397 | 154,113 | 91,002 | ||
| Write-down on inventory 1 January | (89,889) | (45,891) | (45,891) | ||
| Write-down during the period | (14,439) | (11,777) | (46,733) | ||
| Use of write-down | - | - | 2,735 | ||
| Reversal of write-down | 204 | - | - | ||
| Write-down end of period | (104,124) | (57,668) | (89,889) | ||
| 9. Other receivables | |||||
| Receivable VAT and duties | 9,873 | 4,425 | 8,581 | ||
| Accrued interest | 8,887 | 8,975 | 8,272 | ||
| Other receivables | - | 119 | 2,799 | ||
| Other receivables | 18,760 | 13,519 | 19,652 | ||
| 10. Prepayment from customers | |||||
| Prepayments from customers as of January 1 | 405,789 | 375,190 | 375,190 | ||
| Prepayments received during the period | 64,871 | 631,158 | 631,158 | ||
| Repaid during the year | - | - | (21,135) | ||
| Recognized as income during the period | (9,124) | (393,232) | (579,424) | ||
| Prepayments from customers end of period | 461,536 | 613,116 | 405,789 | ||
| 11. Other liabilities | |||||
| Financial instruments at fair value | 5,381 | - | - | ||
| Liability relating to phantom shares | 16,847 | 10,857 | 20,490 | ||
| Payable salaries, holiday accrual etc. | 53,316 | 57,513 | 56,238 | ||
| Other accrued costs | 26,417 | 49,090 | 34,983 | ||
| Other liabilities | 101,961 | 117,460 | 111,711 |
12. Financial instruments
Method and assumption to determine fair value
The Group has financial instruments measured at fair value at level 1 and level 2.
Securities (level 1)
The portfolio of publicly traded government bonds and publicly traded mortgage bonds is valued at listed prices and price quotas.
Derivative financial instruments (level 2)
Currency forward contracts, currency option contracts and currency swap contracts are valued according to generally accepted valuation methods based on relevant observable swap curves and exchange rates.
Fair value hierarchy for financial instruments measured at fair value
As of September 30, 2016
| DKK thousand | Level 1 | Level 2 | Total |
|---|---|---|---|
| Securities | 1,045,190 | - | 1,045,190 |
| Financial assets measured at fair value in the income statement | 1,045,190 | - | 1,045,190 |
| Derivative financial instruments to hedge future cash flow (currency) | - | 1,415 | 1,415 |
| Financial liabilities used as hedging instruments | - | 1,415 | 1,415 |
| Derivative financial instruments at fair value in the income statement (currency) | - | 3,966 | 3,966 |
| Financial liabilities measured at fair value in the income statement | - | 3,966 | 3,966 |
As of December 31, 2015
| DKK thousand | Level 1 | Level 2 | Total |
|---|---|---|---|
| Securities | 684,141 | - | 684,141 |
| Financial assets measured at fair value in the income statement | 684,141 | - | 684,141 |
13. Incentive plans
Outstanding warrants as of September 30, 2016
| Outstanding as of January 1 | Addition during the period | Options exercised | Annulled | Terminated | Transferred | Outstanding as of Sep-tember 30 | |
|---|---|---|---|---|---|---|---|
| Board of Directors | 50,000 | - | (10,000) | - | - | - | 40,000 |
| Corporate Management | 269,802 | - | - | - | - | - | 269,802 |
| Other employees | 877,200 | - | (70,894) | (6,000) | - | (61,000) | 739,306 |
| Retired employees | 427,603 | - | (63,495) | - | (5,000) | 61,000 | 420,108 |
| Total | 1,624,605 | - | (144,389) | (6,000) | (5,000) | - | 1,469,216 |
| Weighted average exercise price | 148 | - | 57 | 367 | 54 | - | 157 |
| Weighted average share price at exercise | - | - | 250 | - | - | - | - |
| Numbers of warrants which can be exercised as of September 30, 2016 | 169,114 | ||||||
| at a weighted average exercise price of DKK | 59 |
The total recognized cost of the warrant programs was DKK 13.7 million in the first nine months of 2016 (DKK 7.9 million).
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 22 of 23
Bavarian Nordic A/S - Financial report for the period January 1 to September 30, 2016
Page 23 of 23
Specification of parameters for Black-Scholes model
| DKK | May 2012 | Aug 2012 | Feb 2013 | Aug 2013 | Dec 2013 | Aug 2014 | Dec 2015 |
|---|---|---|---|---|---|---|---|
| Average share price | 43.30 | 52.00 | 45.50 | 68.00 | 82.00 | 117.50 | 334.00 |
| Average exercise price at grant | 54.00 | 59.10 | 55.00 | 73.90 | 96.50 | 131.40 | 366.85 |
| Expected volatility rate | 52.5% | 50.0% | 28.3% | 36.4% | 35.4% | 39.7% | 53.8% |
| Expected life (years) | 3.3 | 3.3 | 3.1 | 3.3 | 3.3 | 3.3 | 3.3 |
| Expected dividend per share | - | - | - | - | - | - | - |
| Risk-free interest rate p.a. | 0.31% | -0.09% | 0.22% | 0.78% | 0.74% | 0.63% | 0.25% |
| Fair value at grant 1) | 13 | 16 | 6 | 16 | 17 | 29 | 115 |
The expected volatility is based on the historical volatility.
1) Fair value of each warrant at grant applying the Black-Scholes model
14. Significant changes in contingent liabilities and other contractual obligations
No significant changes in contingent liabilities and other contractual obligations have occurred since December 31, 2015.
15. Significant events after the balance sheet date
In October, a Phase 2 clinical trial of MVA-BN RSV was initiated.
16. Approval of the unaudited condensed consolidated interim financial statements
The unaudited condensed consolidated interim financial statements were approved by the Board of Directors and Corporate Management and authorized for issue on November 9, 2016.
Forward-looking statement
This interim report contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section "Risk Management" in this interim report. Bavarian Nordic does not undertake any obligation to update or revise forward looking statements in this interim report nor to confirm such statements in relation to actual results, unless required by law.
Trade marks
IMVAMUNE®, IMVANEX®, MVA-BN® and PROSTVAC® are registered trade marks owned by Bavarian Nordic.