Quarterly Report • Aug 17, 2016
Quarterly Report
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for the Period January 1 to June 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 – June 30, 2016 2 | |
| Product Pipeline 4 | |
| Share Information 10 | |
| Statement from the Board of Directors and Corporate Management 11 | |
| Financial Statements 12 | |
Financial statements are un-audited. Comparison figures for the same period 2015 are stated in parentheses.
Revenue generated for the six months ending June 30, 2016 was DKK 139 million (DKK 624 million). Revenue was generated from the sale of IMVAMUNE, DKK 13 million (DKK 77 million), IMVAMUNE holdback, DKK 81 million (DKK 0 million) and contract work, DKK 46 million (DKK 45 million). As previously announced manufacturing and release of commercial products will primarily occur later in 2016 and thus more than 85% of the year's revenue is expected to be recognized in the second half of 2016. Revenue reported for the three months ended June 30, 2016 was DKK 116 million (DKK 389 million).
The production costs totaled DKK 47 million (DKK 202 million). Costs related directly to revenue amounted to DKK 29 million (DKK 167 million). Other production costs totaled DKK 18 million (DKK 35 million). In the second quarter of 2016, production costs were DKK 28 million (DKK 110 million).
Research and development costs totaled DKK 193 million (DKK 219 million). The decrease is mainly related to the reorganization within research and development in 2015.
Distribution costs totaled DKK 19 million (DKK 27 million) and administrative costs totaled DKK 87 million (DKK 90 million). The decrease in distribution costs compared to 2015 is mainly related to the downsizing of the Californian organization in March 2015. The decrease in administrative costs is also related to the reorganization in California, partly offset by expenses related to the planned U.S. listing, which has been withdrawn.
The income before interest and tax (EBIT) was a loss of DKK 207 million (income of DKK 85 million).
Financial items totaled a net income of DKK 2 million (net income of DKK 63 million). Net income from securities amounted to DKK 14 million (net expense of DKK 4 million) and negative exchange rate adjustments amounted to DKK 10 (positive exchange rate adjustments of DKK 69 million).
Income before company tax was a loss of DKK 204 million (income of DKK 148 million).
Tax on income was an income of DKK 50 million (expense of DKK 41 million), corresponding to an effective tax rate of 24.4%.
For the first six months of 2016, Bavarian Nordic reported a net loss of DKK 155 million (net profit of DKK 107 million), which is in line with the expectations as more than 85% of the year's revenue is expected to be recognized in the second half of 2016.
Inventories have increased by DKK 102 million compared to December 31, 2015. The increase is related to the production of Bulk Drug Substance (BDS) for the U.S. Government in the second half of 2016.
Trade receivables have decreased by DKK 82 million compared to December 31, 2015 as the revenue in the second quarter of 2016 has been low compared to the revenue in the fourth quarter of 2015.
Securities, cash and cash equivalents increased by DKK 444 million compared to December 31, 2015 as a result of the private placement in April raising a net proceeds of DKK 626.
Prepayment from customers have increased by DKK 61 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 June 30, 2016 the Group's cash preparedness was DKK 1,894 million (DKK 1,669 million), including unutilized credit lines of DKK 392 million (DKK 384 million). Cash flow spend on operating activities was DKK 144 million (contribution DKK 306 million). In first quarter 2015 the Company received prepayments 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 399 million (DKK 231 million) primarily due to a net investment in securities of DKK 352 million (DKK 210 million). Cash flow from financing activities contributed with DKK 630 million (DKK 15 million) regarding proceeds from the private placement and warrant exercise. The net change in cash and cash equivalents was DKK 87 million (DKK 90 million).
The Group's equity as of June 30, 2016 stood at DKK 1,804 million (DKK 1,349 million).
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 research and development costs of approximately DKK 550 million are expected and 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 |
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.
Our clinical 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 to the clinical pipeline, 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 1 | Bavarian Nordic |
| MVA-BN HPV | Chronic HPV Infection | Preclinical | Janssen |
| CANCER IMMUNOTHERAPY | |||
| PROSTVAC | Prostate cancer | Phase 3*** | Bristol-Myers Squibb |
| CV301 | Bladder Cancer | Phase 2 | 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 is a non-replicating smallpox vaccine distributed as a liquid-frozen formulation, suitable for use in people for whom replicating smallpox vaccines are contraindicated (e.g. people with HIV and atopic dermatitis). The vaccine 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. 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 nonreplicating smallpox vaccine to protect 66 million people, representing 132 million doses of IMVAMUNE, to address those for whom a replicating smallpox vaccine is contraindicated or who have severe immunodeficiency and who are not expected to benefit from the vaccine.
http://www.bavarian-nordic.com/pipeline/imvamune
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.
Following the announcement of positive Phase 1 results for MVA-BN RSV in May 2016, the Company intends to rapidly progress the RSV vaccine candidate into multiple Phase 1 and Phase 2 trials in elderly and at-risk populations, as well as the pediatric population.
In May, top-line results from the first Phase 1 study of MVA-BN RSV were reported. The randomized, placebo-controlled trial, evaluated the safety, tolerability and immunogenicity of MVA-BN RSV in 63 healthy adults, aged 18-65. Subjects were enrolled into three groups to receive two different dose levels of MVA-BN RSV: adults/low dose, adults/high dose and elderly/high dose. The elderly group enrolled subjects of 50-65 years of age in order to evaluate the immune responses in a population that is one of the key targets for the vaccine.
MVA-BN RSV was well tolerated, with no unexpected or serious adverse reactions. A significant boost in antibodies and T cells against RSV was measured in all groups following vaccination with MVA-BN RSV including neutralizing antibodies against both RSV subtypes A & B. In elderly subjects, there was a significant increase in both blood IgG and IgA antibodies, the latter a specialized antibody that is transported from blood to mucosal surfaces (e.g. nose, throat, lungs). T cell responses against RSV were significantly boosted in elderly subjects vaccinated, with a 3-5 fold increase observed against RSV or the 3 RSV proteins tested to date, including the RSV surface proteins F (fusion) and G (glycoprotein) and the highly conserved nucleocapsid protein (N).The broad T cell response stimulated in the majority of elderly subjects is cross reactive against both RSV subtypes.
Initiate a Phase 2 study in elderly in second half of 2016.
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 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.
Our work with NIAID to develop a multivalent prime-boost vaccine that offers broader protection against multiple filoviruses continues, and we have received USD 33 million in funding for this development to-date.
| Phase | Location | No. of subjects | Study Population | Status |
|---|---|---|---|---|
| Phase 1 | Europe | 87 | Healthy adults | Completed |
| Phase 1 | USA | 164 | Healthy adults | Enrolled |
| Phase 1 | Africa | 72 | Healthy adults | Enrolled |
| Phase 1 | Africa | 78 | Healthy adults | Enrolled |
| Phase 2 | Europe | 612 | Healthy adults | Enrolling |
| Phase 2 | Africa | 1,188 | Healthy adults, elderly & children, HIV-infected adults | Enrolling |
| Phase 2 | USA/Africa | 575 | Healthy and HIV-infected adults | Enrolling |
| Phase 3 | Africa | 728 | Healthy adults & children | Enrolling |
| Phase 3 | USA | 525 | Healthy adults | Enrolled |
| Phase 3 | USA | 329 | Healthy adults | Enrolled |
In April, results from the first Phase 1 study of the Ebola prime-boost regimen were published in JAMA: The Journal of the American Medical Association. The results show that the vaccine regimen produced an antibody response in 100 percent of healthy volunteers that was sustained 8 months following immunization, indicating potential for a durable response.
Report results of ongoing clinical studies of the prime-boost vaccine (Janssen).
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.
Initiate a Phase 1 clinical study in 2017
Under an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), Bavarian Nordic has generated an MVA-BN based vaccine candidate against yellow fever. A preclinical study sponsored by NIAID demonstrated that the vaccine candidate provided complete protection against infection with the virus. Preclinical studies have furthermore suggested that combining MVA-BN with ISA 720, an adjuvant that has been used in prior clinical trials, induced a strong immune response after a single vaccination. This potential will be further investigated as part of the Phase 1 trial.
A Phase 1 study of an MVA-BN-based vaccine against yellow fever was initiated in July by NIAID. The study will enroll 90 healthy adults in six groups: one that will receive the currently licensed yellow fever vaccine (15 participants) and five groups (15 participants each) will receive MVA-BN-YF, either with or without the ISA 720 adjuvant.
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, 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. The product candidate is currently in Phase 3 development for the treatment of patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). A robust data package has been established that includes 17 ongoing or completed clinical studies, comprising more than 2,000 patients of which more than 1,100 patients 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.
PROSTVAC is currently the subject of a global randomized, double-blind, placebo-controlled Phase 3 trial of PROSTVAC in 1,297 patients with asymptomatic or minimally symptomatic mCRPC.
The primary objective of the trial is to determine whether the overall survival 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 the administration of GM-CSF with PROSTVAC may not be required. The trial is designed to potentially rule out the need for GM-CSF.
Final study data are anticipated in 2017 upon the occurrence of 534 events (deaths) in both comparisons of treatment arms versus placebo, i.e. when at least 534 events have been recorded both in the comparison of the PROSTVAC + GM-CSF group and placebo group and in the comparison of the PROSTVAC only group and placebo group. Although the trial is powered to detect a difference in survival between active treatment and placebo at final analysis, 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 first and second interim analysis occurred after 214 and 321 events respectively, both confirming that the study should continue as planned without modification. A third interim analysis will occur at 427 events.
To leverage the full potential of PROSTVAC, Bavarian Nordic and Bristol-Myers Squibb have agreed to conduct exploratory combination studies of PROSTVAC with or without agents from Bristol-Myers Squibb's immunooncology portfolio, including ipilimumab (Yervoy® ) and nivolumab (Opdivo® ). 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.
| 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 |
Enrolling |
| PROSTVAC | Patients at risk of relapse after radical prostatectomy |
Phase 2 44 patients |
Enrolling |
| PROSTVAC + ipi | Localized prostate cancer, neoadjuvant Patients undergoing radical prostatectomy |
Phase 2 75 patients |
Planned |
| PROSTVAC + flutamide | Non-metastatic prostate cancer | Phase 2 53 patients |
Fully enrolled |
| PROSTVAC | Non-metastatic castration sensitive prostate cancer |
Phase 2 80 patients |
Enrolling |
| PROSTVAC + enza | 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 + enza | mCRPC | Phase 2 76 patients |
Enrolling |
| PROSTVAC | mCRPC | Phase 3 1,297 patients |
Fully enrolled |
ipi: ipilimumab, enza: enzalutamide, ADT: androgen-deprivation therapy
http://www.bavarian-nordic.com/pipeline/prostvac
CV301 is an immunotherapy candidate which is being developed under a CRADA with the NCI. CV301 employs two poxviruses (vaccinia and fowlpox) in a prime-boost vaccine regime which carries two tumor-associated antigens, CEA and MUC-1, which are over-expressed in major cancer types. CV301 has been tested in six NCIsponsored clinical trials in various cancers, and more than 300 patients have been treated with the product candidate. Currently, a Phase 2 clinical trial is ongoing in bladder cancer.
We have generated a new and improved vaccine construct, in which the vaccinia primer has been replaced with MVA-BN. This new version will be employed in the future development of CV301, focusing on combination treatments with checkpoint inhibitors.
While non-small cell lung cancer (NSCLC) represents the first clinical target, we plan to initiate no less than three separate randomized, placebo-controlled Phase 2 trials in NSCLC, bladder cancer and colorectal cancer, in combination with assorted checkpoint inhibitors. These studies will evaluate the efficacy of the vaccine and the checkpoint inhibitor to determine what, if any, synergy can be seen in combination. As it pertains to NSCLC, overall survival (OS) will be the primary endpoint for the study, but additional secondary endpoints such as progression free survival (PFS) and overall response rate (ORR), will be investigated. These secondary endpoints may provide a signal of activity prior to an OS endpoint.
In August, Bavarian Nordic entered a drug supply agreement with Bristol-Myers Squibb, providing OPDIVO® (nivolumab) for the upcoming clinical trial of CV301 as combination therapy in non-small cell lung cancer.
Initiate a Phase 2 study of CV301 in combination with checkpoint inhibitors in NSCLC and additional indications
http://www.bavarian-nordic.com/pipeline/cv-301
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.
Initiate NCI-sponsored Phase 2 study of MVA-BN Brachyury.
http://www.bavarian-nordic.com/pipeline/mva-bn-brachyury
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.
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. Bavarian Nordic expects to use the proceeds from the offering to accelerate its commercial vaccine pipeline, including its CV301 cancer immunotherapy and MVA-BN RSV program, as well as for potential expansion of Bavarian Nordic's existing manufacturing facility.
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.
Consequently, at June 30, 2016, the Company's share capital amounts to DKK 309,282,120, which is made up of 30,928,212 shares with a nominal value of DKK 10 each. There were 1,475,064 outstanding warrants, which entitle warrant holders to subscribe for 1,475,064 shares with a nominal value of DKK 10 each. Thus the fully diluted share capital amounted to DKK 32,403,276 at the end of first half 2016.
9 November 2016 Financial Statements for the first nine months of 2016 (Q3)
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 June 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 June 30, 2016 and the results of the group's activities and cash flows for the period January 1 to June 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, August 17, 2016
Corporate Management:
Paul Chaplin Ole Larsen
President and CEO Executive Vice President & CFO
Board of Directors:
Gerard van Odijk Anders Gersel Pedersen Claus Bræstrup Chairman of the Board Deputy Chairman
Erik G. Hansen Peter Kürstein Frank Verwiel
| DKK thousand | 1/4 - 30/6 2016 1/4 - 30/6 2015 1/1 - 30/6 2016 1/1 - 30/6 2015 1/1-31/12 2015 | ||||
|---|---|---|---|---|---|
| Income statements | |||||
| Revenue | 116,557 | 389,126 | 139,115 | 623,915 | 1,020,561 |
| Production costs | 28,310 | 110,022 | 47,207 | 202,136 | 415,138 |
| Research and development costs | 89,126 | 100,620 | 193,436 | 219,185 | 386,811 |
| Distribution costs | 11,738 | 9,998 | 18,697 | 27,425 | 42,272 |
| Administrative costs | 41,425 | 43,516 | 86,562 | 90,398 | 174,786 |
| Income before interest and taxes (EBIT) | (54,042) | 124,970 | (206,787) | 84,771 | 1,554 |
| Financial items, net | 18,869 | (40,437) | 2,380 | 62,743 | 76,075 |
| Income before company tax | (35,173) | 84,533 | (204,407) | 147,514 | 77,629 |
| Net profit for the period | (25,782) | 61,360 | (154,535) | 106,736 | 59,426 |
| Balance sheet | |||||
| Total non-current assets | 636,508 | 518,051 | 585,005 | ||
| Total current assets | 1,845,206 | 1,702,683 | 1,404,258 | ||
| Total assets | 2,481,714 | 2,220,734 | 1,989,263 | ||
| Equity | 1,804,481 | 1,348,922 | 1,342,479 | ||
| Non-current liabilities | 55,521 | 50,911 | 56,550 | ||
| Current liabilities | 621,712 | 820,901 | 590,234 | ||
| Cash flow statements | |||||
| Securities, cash and cash equivalents | 1,502,036 | 1,285,024 | 1,058,204 | ||
| Cash flow from operating activities | (144,444) | 306,314 | 105,323 | ||
| Cash flow from investment activities | (398,506) | (231,029) | (178,123) | ||
| - Investment in intangible assets | (24,818) | (14,173) | (28,269) | ||
| - Investment in property, plant and equipment | (21,691) | (6,727) | (31,652) | ||
| Cash flow from financing activities | 629,947 | 15,136 | 26,569 | ||
| Financial Ratios (DKK) 1) | |||||
| Earnings (basic) per share of DKK 10 | (5.3) | 3.8 | 2.1 | ||
| Net asset value per share | 58.3 | 48.5 | 47.9 | ||
| Share price at period-end | 233 | 312 | 358 | ||
| Share price/Net asset value per share | 4.0 | 6.4 | 7.5 | ||
| Number of outstanding shares at period-end | 30,928 | 27,812 | 28,020 | ||
| Equity share | 73% | 61% | 67% | ||
| Number of employees, converted to full-time, at period-end | 427 | 419 | 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).
(stated in the end of this document):
Significant accounting policies
| DKK thousand | Note | 1/4 - 30/6 2016 1/4 - 30/6 2015 1/1 - 30/6 2016 1/1 - 30/6 2015 1/1-31/12 2015 | ||||
|---|---|---|---|---|---|---|
| Revenue | 3 | 116,557 | 389,126 | 139,115 | 623,915 | 1,020,561 |
| Production costs | 4 | 28,310 | 110,022 | 47,207 | 202,136 | 415,138 |
| Gross profit | 88,247 | 279,104 | 91,908 | 421,779 | 605,423 | |
| Research and development costs | 5 | 89,126 | 100,620 | 193,436 | 219,185 | 386,811 |
| Distribution costs | 11,738 | 9,998 | 18,697 | 27,425 | 42,272 | |
| Administrative costs | 41,425 | 43,516 | 86,562 | 90,398 | 174,786 | |
| Total operating costs | 142,289 | 154,134 | 298,695 | 337,008 | 603,869 | |
| Income before interest and tax (EBIT) | (54,042) | 124,970 | (206,787) | 84,771 | 1,554 | |
| Financial income | 6 | 8,140 | (25,899) | 13,942 | 75,912 | 99,357 |
| Financial expenses | 7 | (10,729) | 14,538 | 11,562 | 13,169 | 23,282 |
| Income before company tax | (35,173) | 84,533 | (204,407) | 147,514 | 77,629 | |
| Tax on income for the period | (9,391) | 23,173 | (49,872) | 40,778 | 18,203 | |
| Net profit for the period | (25,782) | 61,360 | (154,535) | 106,736 | 59,426 | |
| Earnings per share (EPS) - DKK | ||||||
| Basic earnings per share of DKK 10 | (0.9) | 2.2 | (5.3) | 3.8 | 2.1 | |
| Diluted earnings per share of DKK 10 | (0.9) | 2.2 | (5.3) | 3.8 | 2.1 |
| DKK thousand | 1/4 - 30/6 2016 1/4 - 30/6 2015 1/1 - 30/6 2016 1/1 - 30/6 2015 1/1-31/12 2015 | ||||
|---|---|---|---|---|---|
| Net profit for the period | (25,782) | 61,360 | (154,535) | 106,736 | 59,426 |
| Items that might be reclassified to the income statement: |
|||||
| Exchange rate adjustments on translating | |||||
| foreign operations | (7,735) | 11,515 | 6,049 | (32,601) | (38,371) |
| Fair value of financial instruments entered | |||||
| into to hedge future cash flow: | |||||
| Fair value adjustment for the period | (5,367) | - | (5,367) | - | - |
| Tax on other comprehensive income | 1,181 | - | 1,181 | - | - |
| Other comprehensive income after tax | (11,921) | 11,515 | 1,863 | (32,601) | (38,371) |
| Total comprehensive income | (37,703) | 72,875 | (152,672) | 74,135 | 21,055 |
| DKK thousand | Note | 30/6 2016 | 30/6 2015 | 31/12 2015 |
|---|---|---|---|---|
| Assets | ||||
| Software | 5,170 | 4,093 | 3,194 | |
| IMVAMUNE development project | 114,476 | 88,244 | 100,500 | |
| Intangible assets in progress | 12,052 | 2,384 | 4,495 | |
| Intangible assets | 131,698 | 94,721 | 108,189 | |
| Land and buildings | 210,512 | 220,645 | 218,610 | |
| Leasehold improvements | 835 | 758 | 402 | |
| Plant and machinery | 62,169 | 61,839 | 53,562 | |
| Fixtures and fittings, other plant and equipment | 17,601 | 18,551 | 19,358 | |
| Assets under construction | 35,720 | 21,334 | 33,828 | |
| Property, plant and equipment | 326,837 | 323,127 | 325,760 | |
| Other receivables | 1,070 | 813 | 914 | |
| Financial assets | 1,070 | 813 | 914 | |
| Deferred tax assets | 176,903 | 99,390 | 150,142 | |
| Total non-current assets | 636,508 | 518,051 | 585,005 | |
| Development projects for sale | 70,069 | 66,931 | 70,069 | |
| Inventories | 8 | 192,676 | 140,527 | 91,002 |
| Trade receivables | 56,154 | 183,257 | 137,927 | |
| Tax receivables | 5,424 | 3,111 | 4,174 | |
| Other receivables | 9 | 12,916 | 11,093 | 19,652 |
| Prepayments | 5,931 | 12,740 | 23,230 | |
| Receivables | 80,425 | 210,201 | 184,983 | |
| Securities | 1,042,816 | 779,814 | 684,141 | |
| Cash and cash equivalents | 459,220 | 505,210 | 374,063 | |
| Securites, cash and cash equivalents | 1,502,036 | 1,285,024 | 1,058,204 | |
| Total current assets | 1,845,206 | 1,702,683 | 1,404,258 | |
| Total assets | 2,481,714 | 2,220,734 | 1,989,263 |
| DKK thousand | Note | 30/6 2016 | 30/6 2015 | 31/12 2015 |
|---|---|---|---|---|
| Equity and liabilities | ||||
| Share capital | 309,282 | 278,120 | 280,197 | |
| Treasury shares | (111) | - | - | |
| Retained earnings | 1,517,968 | 1,099,687 | 1,066,558 | |
| Other reserves | (22,658) | (28,885) | (4,276) | |
| Equity | 1,804,481 | 1,348,922 | 1,342,479 | |
| Provisions | 25,226 | 18,603 | 25,226 | |
| Debt to credit institutions | 30,295 | 32,308 | 31,324 | |
| Non-current liabilities | 55,521 | 50,911 | 56,550 | |
| Debt to credit institutions | 2,024 | 1,937 | 1,969 | |
| Prepayment from customers | 10 | 466,960 | 626,772 | 405,789 |
| Trade payables | 56,397 | 47,211 | 69,574 | |
| Company tax | 468 | 43 | 621 | |
| Provisions | - | 4,216 | 570 | |
| Other liabilities | 11 | 95,863 | 140,722 | 111,711 |
| Current liabilities | 621,712 | 820,901 | 590,234 | |
| Total liabilities | 677,233 | 871,812 | 646,784 | |
| Total equity and liabilities | 2,481,714 | 2,220,734 | 1,989,263 |
| DKK thousand | 1/1 - 30/6 2016 1/1 - 30/6 2015 1/1-31/12 2015 | ||
|---|---|---|---|
| Net profit for the period | (154,535) | 106,736 | 59,426 |
| Adjustment for non-cash items: | |||
| Financial income | (13,942) | (75,912) | (99,357) |
| Financial expenses | 11,562 | 13,169 | 23,282 |
| Tax on income for the period | (49,872) | 40,778 | 18,203 |
| Depreciation, amortization and impairment losses | 21,696 | 21,755 | 43,525 |
| Expensing (amortization) of IMVAMUNE development project | 181 | 2,690 | 2,694 |
| Share-based payment | 3,266 | 15,714 | 26,746 |
| Changes in development projects for sale | - | (40,006) | (41,656) |
| Changes in inventories | (101,674) | (18,680) | 30,845 |
| Changes in receivables | 108,339 | 229,394 | 28,017 |
| Changes in provisions | (570) | 2 | (878) |
| Changes in current liabilities | 44,944 | 2,383 | (12,470) |
| Cash flow from operations (operating activities) | (130,605) | 298,023 | 78,377 |
| Received financial income | 4,900 | 25,746 | 43,742 |
| Paid financial expenses | (15,062) | (1,524) | (2,935) |
| Paid company taxes | (3,677) | (15,931) | (13,861) |
| Cash flow from operating activities | (144,444) | 306,314 | 105,323 |
| Investments in and additions to intangible assets | (24,818) | (14,173) | (28,269) |
| Investments in property, plant and equipment | (21,691) | (6,727) | (31,652) |
| Disposal of property, plant and equipment | - | - | 1,200 |
| Investments in/disposal of financial assets | (156) | (20) | (122) |
| Investments in securities | (487,186) | (450,009) | (734,557) |
| Disposal of securities | 135,345 | 239,900 | 615,277 |
| Cash flow from investment activities | (398,506) | (231,029) | (178,123) |
| Payment on mortgage and construction loan | (974) | (933) | (1,885) |
| Proceeds from warrant programs exercised | 7,943 | 16,069 | 28,595 |
| Proceeds from private placement | 664,800 | - | - |
| Cost related to issue of new shares | (38,973) | - | (141) |
| Purchase of treasury shares | (2,849) | - | - |
| Cash flow from financing activities | 629,947 | 15,136 | 26,569 |
| Cash flow of the period | 86,997 | 90,421 | (46,231) |
| Cash as of 1 January | 374,063 | 398,357 | 398,357 |
| Currency adjustments 1 January | (1,840) | 16,432 | 21,937 |
| Cash end of period | 459,220 | 505,210 | 374,063 |
| Reserves for | |||||||
|---|---|---|---|---|---|---|---|
| Reserves for | fair value of | ||||||
| Share | Treasury | Retained | currency | financial | Share-based | ||
| DKK thousand | capital | shares | earnings | adjustment | instruments | 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 | - | - | (154,535) | - | - | - | (154,535) |
| Other comprehensive income Exchange rate adjustments on |
|||||||
| translating foreign operations | - | - | - | 6,049 | - | - | 6,049 |
| Fair value of financial instruments | - | - | - | - | (4,186) | - | (4,186) |
| Total comprehensive income for | |||||||
| the period | - | - | (154,535) | 6,049 | (4,186) | - | (152,672) |
| Transactions with owners | |||||||
| Share-based payment | - | - | - | - | - | 10,325 | 10,325 |
| Warrant program exercised | 1,385 | - | 8,428 | - | - | (1,870) | 7,943 |
| Warrant program expired | - | - | 120 | - | - | (120) | - |
| Capital increase through private | |||||||
| placement | 27,700 | - | 637,100 | - | - | - | 664,800 |
| Cost related to issue of new shares | - | - | (38,973) | - | - | - | (38,973) |
| Purchase of treasury shares | - | (111) | (730) | - | - | (2,008) | (2,849) |
| Tax related to items recognized | |||||||
| directly in equity | - | - | - | - | - | (26,572) | (26,572) |
| Total transactions with owners | 29,085 | (111) | 605,945 | - | - | (20,245) | 614,674 |
| Equity as of June 30, 2016 | 309,282 | (111) 1,517,968 | (67,507) | (4,186) | 49,035 | 1,804,481 |
| Reserves for | |||||||
|---|---|---|---|---|---|---|---|
| Reserves for | fair value of | ||||||
| Share | Treasury | Retained | currency | financial | Share-based | ||
| DKK thousand | capital | shares | earnings | adjustment | instruments | 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 | - | - | 106,736 | - | - | - | 106,736 |
| Other comprehensive income | |||||||
| Exchange rate adjustments on | |||||||
| translating foreign operations | - | - | - | (32,601) | - | - | (32,601) |
| Total comprehensive income for | |||||||
| the period | - | - | 106,736 | (32,601) | - | - | 74,135 |
| Transactions with owners | |||||||
| Share-based payment | - | - | - | - | - | 6,624 | 6,624 |
| Warrant program exercised | 1,407 | - | 20,631 | - | - | (5,969) | 16,069 |
| Total transactions with owners | 1,407 | - | 20,631 | - | - | 655 | 22,693 |
| Equity as of June 30, 2015 | 278,119 | - | 1,099,688 | (67,786) | - | 38,901 | 1,348,922 |
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.
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.
| DKK thousand | 1/4 - 30/6 2016 1/4 - 30/6 2015 1/1 - 30/6 2016 1/1 - 30/6 2015 1/1-31/12 2015 | ||||
|---|---|---|---|---|---|
| 3. Revenue | |||||
| IMVAMUNE sale | 4,939 | 12,499 | 12,783 | 77,422 | 77,813 |
| Other product sale | - | 357,020 | - | 501,300 | 762,054 |
| Sale of goods | 4,939 | 369,519 | 12,783 | 578,722 | 839,867 |
| IMVAMUNE sale, development results | 80,746 | - | 80,746 | - | - |
| Contract work | 30,872 | 19,607 | 45,586 | 45,193 | 180,694 |
| Sale of services | 111,618 | 19,607 | 126,332 | 45,193 | 180,694 |
| Revenue | 116,557 | 389,126 | 139,115 | 623,915 | 1,020,561 |
| 4. Production costs | |||||
| Cost of goods sold, IMVAMUNE sale | 168 | 1,456 | 1,801 | 20,483 | 20,511 |
| Cost of goods sold, other product sale | - | 73,863 | - | 119,297 | 171,209 |
| Contract costs | 18,146 | 17,385 | 27,317 | 27,705 | 108,678 |
| Other production costs | 9,996 | 17,318 | 18,089 | 34,651 | 114,740 |
| Production costs | 28,310 | 110,022 | 47,207 | 202,136 | 415,138 |
| 5. Research and development costs | |||||
| Research and development costs occured in | |||||
| the period | 114,213 | 123,156 | 234,728 | 256,777 | 517,632 |
| Of which: | |||||
| Contract costs recognized as production | |||||
| costs | (18,146) | (17,385) | (27,317) | (27,705) | (108,678) |
| Capitalized development costs | (6,960) | (5,329) | (14,156) | (12,577) | (24,837) |
| 89,107 | 100,442 | 193,255 | 216,495 | 384,117 | |
| Expensing (amortization) of prior-year | |||||
| costs attributable to the IMVAMUNE | |||||
| development project | 19 | 178 | 181 | 2,690 | 2,694 |
| Research and development costs | 89,126 | 100,620 | 193,436 | 219,185 | 386,811 |
| 6. Financial income | |||||
| Interest income | 252 | - | 252 | - | 38 |
| Interest income from financial assets not | |||||
| measured at fair value in the income | |||||
| statement | 252 | - | 252 | - | 38 |
| Financial income from securities | 3,752 | 4,009 | 7,014 | 7,251 | 14,959 |
| Fair value adjustments on securities | 4,136 | - | 6,676 | - | - |
| Net gains on derivative financial | |||||
| instruments at fair value in the income | |||||
| statement | - | - | - | - | 17,402 |
| Net foreign exchange gains | - | (29,908) | - | 68,661 | 66,958 |
| Financial income | 8,140 | (25,899) | 13,942 | 75,912 | 99,357 |
| DKK thousand | 1/4 - 30/6 2016 1/4 - 30/6 2015 1/1 - 30/6 2016 1/1 - 30/6 2015 1/1-31/12 2015 | ||||
|---|---|---|---|---|---|
| 7. Financial expenses | |||||
| Interest expenses on debt | 754 | 998 | 1,308 | 1,422 | 2,676 |
| Interest expenses on financial liabilities not | |||||
| measured at fair value in the income | |||||
| statement | 754 | 998 | 1,308 | 1,422 | 2,676 |
| Fair value adjustments on securities | - | 13,540 | - | 11,747 | 16,749 |
| Adjustment of net present value of | |||||
| provisions | - | - | - | - | 3,857 |
| Net foreign exchange losses | (11,483) | - | 10,254 | - | - |
| Financial expenses | (10,729) | 14,538 | 11,562 | 13,169 | 23,282 |
| DKK thousand | 30/6 2016 | 30/6 2015 | 31/12 2015 | ||
| 8. Inventories | |||||
| Raw materials and supply materials | 34,691 | 27,367 | 31,785 | ||
| Work in progress | 245,867 | 158,284 | 135,589 | ||
| Manufactured goods and commodities | 10,925 | 9,001 | 13,517 | ||
| Write-down on inventory Inventories |
(98,807) | (54,125) | (89,889) | ||
| 192,676 | 140,527 | 91,002 | |||
| Write-down on inventory 1 January | (89,889) | (45,891) | (45,891) | ||
| Write-down during the period | (9,122) | (8,234) | (46,733) | ||
| Use of write-down | - | - | 2,735 | ||
| Reversal of write-down | 204 | - | - | ||
| Write-down end of period | (98,807) | (54,125) | (89,889) | ||
| 9. Other receivables | |||||
| Receivable VAT and duties | 7,011 | 3,589 | 8,581 | ||
| Financial instruments at fair value | - | 1,263 | - | ||
| Accrued interest | 5,905 | 6,241 | 8,272 | ||
| Other receivables | - | - | 2,799 | ||
| Other receivables | 12,916 | 11,093 | 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 | 627,963 | 631,158 | ||
| Repaid during the year | - | - | (21,135) | ||
| Recognized as income during the period | (3,700) | (376,381) | (579,424) | ||
| Prepayments from customers end of period | 466,960 | 626,772 | 405,789 | ||
| 11. Other liabilities | |||||
| Financial instruments at fair value | 5,367 | - | - | ||
| Liability relating to phantom shares | 13,366 | 12,120 | 20,490 | ||
| Payable salaries, holiday accrual etc. | 50,556 | 61,480 | 56,238 | ||
| Other accrued costs | 26,574 | 67,122 | 34,983 | ||
| Other liabilities | 95,863 | 140,722 | 111,711 |
The Group has financial instruments measured at fair value at level 1 and level 2.
The portfolio of publicly traded government bonds and publicly traded mortgage bonds is valued at listed prices and price quotas.
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
| DKK thousand | Level 1 | Level 2 | Total |
|---|---|---|---|
| Securities | 1,042,816 | - | 1,042,816 |
| Financial assets measured at fair value in the income statement | 1,042,816 | - | 1,042,816 |
| Derivative financial instruments to hedge future cash flow (currency) | - | 5,367 | 5,367 |
| Financial liabilities used as hedging instruments | - | 5,367 | 5,367 |
Outstanding warrants as of June 30, 2016
| Outstanding | Addition | Outstanding | |||||
|---|---|---|---|---|---|---|---|
| as of | during | Options | Trans | as of June | |||
| January 1 | the period | exercised | Annulled Terminated | ferred | 30 | ||
| Board of Directors | 50,000 | - | (10,000) | - | - | - | 40,000 |
| Corporate Management | 269,802 | - | - | - | - | - | 269,802 |
| Other employees | 877,200 | - | (70,546) | (6,000) | - | - | 800,654 |
| Retired employees | 427,603 | - | (57,995) | - | (5,000) | - | 364,608 |
| Total | 1,624,605 | - | (138,541) | (6,000) | (5,000) | - | 1,475,064 |
| Weighted average exercise | |||||||
| price | 148 | - | 5 7 |
367 | 5 4 |
- | 156 |
| Weighted average share price | |||||||
| at exercise | - | - | 250 | - | - | - | - |
| Numbers of warrants which can be exercised as of June 30, 2016 | 174,962 | ||||||
| at a weighted average exercise price of DKK | 58 |
The total recognized cost of the warrant programs was DKK 8.2 million in the first six months of 2016 (DKK 6.6 million).
| May | Aug | Feb | Aug | Dec | Aug | Dec | |
|---|---|---|---|---|---|---|---|
| DKK | 2012 | 2012 | 2013 | 2013 | 2013 | 2014 | 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
No significant changes in contingent liabilities and other contractual obligations have occurred since December 31, 2015.
In August, Bavarian Nordic entered a drug supply agreement with Bristol-Myers Squibb, providing OPDIVO® (nivolumab) for upcoming clinical trial of CV301 as combination therapy in non-small cell lung cancer.
In July, a Phase 1 clinical study of MVA-BN YF, a new vaccine candidate generated by Bavarian Nordic, was initiated by the U.S. National Institute of Allergy and Infectious Diseases.
The unaudited condensed consolidated interim financial statements were approved by the Board of Directors and Corporate Management and authorized for issue on August 17, 2016.
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.
IMVAMUNE® , IMVANEX® , MVA-BN® and PROSTVAC® are registered trade marks owned by Bavarian Nordic.
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