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REG - Oxford Biomedica PLC - PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DEC 2016 <Origin Href="QuoteRef">OXB.L</Origin> - Part 2

- Part 2: For the preceding part double click  ID:nRSP6201Za 

                                            
 Loss for the year                                       -                -                      -               -                 -               (13,019)            (13,019)      
 Total comprehensive expense for the year                -                -                      -               -                 -               (13,019)            (13,019)      
 Transactions with owners:Share options                                                                                                                                              
 Proceeds from shares issued                             82               62                     -               -                 -               -                   144           
 Value of employee services                              -                -                      -               -                 -               730                 730           
 Vesting of deferred share             award             -                -                      -               124               -               (124)               -             
 Liquidation of BioMedica inc.                           -                -                      -               -                 682             (682)               -             
 At 31 December 2015                                     25,741           141,677                2,291           (102)             -               (158,713)           10,894        
                                                                                                                                                                                     
 Year ended 31 December 2016:                                                                                                                                                        
 Loss for the year                                       -                -                      -               -                 -               (16,641)            (16,641)      
 Total comprehensive expense for the year                -                -                      -               -                 -               (16,641)            (16,641)      
 Transactions with owners:Share options                                                                                                                                              
 Proceeds from shares     issued                         20               39                     -               -                 -               -                   59            
 Value of employee     services                          -                -                      -               -                 -               865                 865           
 Issue of shares excluding               options         5,118            14,445                 -               -                 -               -                   19,563        
 Cost of share issues                                    -                (2,125)                -               -                 -               -                   (2,125)       
 At 31 December 2016                                     30,879           154,036                2,291           (102)             -               (174,489)           12,615        
                                                                                                                                                                                     
 
 
The notes on pages 19 to 25 form part of this preliminary information. 
 
NOTES TO THE PRELIMINARY FINANCIAL INFORMATION 
 
for the year ended 31 December 2016 
 
1   Basis of preparation 
 
This financial information, for the years ended 31 December 2016 and 31
December 2015, does not constitute the statutory financial statements for the
respective years, and is an extract from the financial statements. It is based
on, and is consistent with, that in the Group's statutory accounts for the
year ended 31 December 2016 and those financial statements will be delivered
to the Registrar of Companies following the Company's Annual General Meeting.
Financial statements for the year ended 31 December 2015 have been delivered
to the Registrar of Companies. The auditors' reports on the financial
statements for the years ended 31 December 2016 and 31 December 2015 were
unqualified and did not contain statements under section 498 of the Companies
Act 2006. The financial information in this report does not constitute a
statutory financial statement within the meaning of sections 434-436 of the
Companies Act 2006. 
 
The financial statements have been prepared in accordance with IFRIC
interpretations, as applicable to companies using International Financial
Reporting Standards ('IFRS') as adopted by the European Union and with the
Companies Act 2006 under the historic cost convention.  Whilst the financial
information included in this preliminary announcement has been prepared in
accordance with IFRSs adopted for use in the European Union, this announcement
does not itself contain sufficient information to comply with IFRSs. 
 
Copies of this announcement are available from the Company Secretary, and are
on the Group's website. The audited statutory financial statements for the
year ended 31 December 2016 are expected to be distributed to shareholders by
27 April 2017 and will be available at the registered office of the Company,
Windrush Court, Transport Way, Oxford, OX4 6LT. Details can also be found on
the Group's website at: www.oxfordbiomedica.co.uk. 
 
This announcement was approved by the Board of Oxford BioMedica plc on 15
March 2017. 
 
Going concern 
 
The Group held £15.3 million of cash at the end of 2016 and £15.2 million at
28 February 2017. During 2016 the cash burn was significantly reduced as a
result of improved cash flow from operations and reduced capital expenditure
and the directors expect further progress in 2017.  Taking this into account,
in conjunction with currently known and probable cash flows, the Directors
consider that the Group has sufficient cash resources and cash inflows to
continue its activities for not less than twelve months from the date of these
financial statements and have therefore prepared the financial statements on a
going concern basis. 
 
2   Critical accounting judgements and estimates 
 
In applying the Group's accounting policies, management is required to make
judgements and assumptions concerning the future in a number of areas. Actual
results may be different from those estimated using these judgements and
assumptions. The key sources of estimation uncertainty and critical accounting
judgements that have a significant risk of causing a material adjustment to
the carrying amounts of assets and liabilities within the next financial year
are discussed below. 
 
Revenue recognition 
 
In October 2014, the Group entered into a series of contractual arrangements
with Novartis, including a licence over the Group's existing LentiVector®
platform, a production and clinical supply agreement and an agreement covering
process development. 
 
Under these arrangements, the Group received $9.7m (£6.1m) in upfront payments
of which $7.7m (£4.8m) was received in respect of a non-exclusive worldwide
development and commercialisation licence in oncology under the Group's
existing LentiVector® intellectual property gene delivery platform. 
 
Management judged that this amount should be recognised as a separate
deliverable in 2014 discrete from amounts to be recognised over the period of
the three year production contract. This judgement was based on management
being satisfied that the customer was able and intended to realise value from
this licence independently from any further intellectual property generated in
the collaboration and that its fair value is sufficiently reliable. In
reaching this judgement management had regard to several considerations
including: 
 
-     The existing intellectual property covered by the licence is sufficient
to allow the vector for CTL019 to be bioprocessed for commercial use, and any
intellectual property that might arise from the process development under the
contract is not a pre-requisite for its commercial manufacture 
 
-     The licence allows Novartis to use the existing intellectual property
for other oncology products apart from CTL019 
 
-     The other elements of the arrangements have an appropriate price and
fair value (the residual elements) 
 
-     The $7.7m fee is comparable with similar transactions with third parties
that the Group has previously contracted, taking into account the stage of
development and the market potential of the product 
 
This judgement reflects both the separability of the licence for the existing
intellectual property and the assessment of the fair values of each of the
components of the Novartis agreements. 
 
The remaining $2.0m of the $9.7m upfront payments are dependent on certain
events and activities over the 3 year period. As at 31 December 2016, $1.2m
had been recognised as revenue (2015: $0.4m). 
 
Under the October 2014 contract, management judged that $1.2m of a $2m
incentive payment for provision of source documentation to support a proposed
BLA submission by Novartis should be recognised at year end on the basis that,
based on the level of work performed, it is certain that the economic benefits
of the transaction will flow to the entity, and the revenue and related costs
can be measured reliably. 
 
In 2016 the Group received £1.4m in one-off payments related to IP licences.
Since these payments are non-refundable and there is no ongoing commitment
from the Group, the amounts received have been recognised as revenue in the
year. £657,000 of these items was received in the form of shares in a partner
company. These have been recognised at fair value. 
 
Intangible asset impairment 
 
The Group has intangible assets arising from purchases of intellectual
property rights and in-process R&D. Amortisation is charged over the assets'
patent life on a straight line basis from the date that the asset becomes
available for use. When there is an indicator of a significant and permanent
reduction in the value of intangible assets, an impairment review is carried
out. The impairment analysis is principally based on estimated discounted
future cash flows. Actual outcomes could vary significantly from such
estimates of discounted future cash flows due to the sensitivity of the
assessment to the assumptions used. The determination of the assumptions is
subjective and requires the exercise of considerable judgement. Any changes in
key assumptions about the Group's business and prospects, or changes in market
conditions affecting the Group, or its development partners, could materially
affect whether an impairment exists. This risk is now concentrated on
purchased patent rights which have been sublicensed to collaborative partners.
At 31 December 2016 the book value of intangible assets was £1.3 million of
which £1.1 million related to PrimeBoost technology. 
 
Going concern 
 
Management and the Directors have had to make estimates and important
judgements when assessing the going concern status of the Group.  Going
concern is as stated in Note 1 and the Financial review. 
 
3   Taxation 
 
The Group is entitled to claim tax credits in the United Kingdom for certain
research and development expenditure. The amount included in the statement of
comprehensive income for the year ended 31 December 2016 comprises the credit
receivable by the Group for the year, less overseas tax paid in the year. The
United Kingdom corporation tax research and development credit is paid in
arrears once tax returns have been filed and agreed. The tax credit recognised
in the financial statements, but not yet received, is included in current
assets in the balance sheet. The amounts for 2016 have not yet been agreed
with the relevant tax authorities. 
 
                                                                 2016     2015     
                                                                 £'000    £'000    
 Current tax                                                                       
 United Kingdom corporation tax research and development credit  (3,000)  (2,721)  
 Overseas taxation                                               50       5        
                                                                 (2,950)  (2,716)  
 Adjustments in respect of prior periods                                           
 United Kingdom corporation tax research and development credit  (716)    (1,247)  
 Taxation credit                                                 (3,666)  (3,963)  
 
 
4   Basic loss and diluted loss per ordinary share 
 
The basic loss per share of 0.60p (2015:0.51p) has been calculated by dividing
the loss for the year by the weighted average number of shares in issue during
the year ended 31 December 2016 (2,778,182,534: 2015: 2,570,202,150). 
 
As the Group is loss-making, there were no potentially dilutive options in
either year. There is therefore no difference between the basic loss per
ordinary share and the diluted loss per ordinary share. 
 
5   Intangible assets 
 
Intangible assets comprise Intellectual Property rights. 
 
                                            2016   2015   
                                            £'000  £'000  
 At 1 January and 31 December               5,591  5,591  
                                                          
 Accumulated amortisation and impairment                  
 At 1 January                               3,848  3,485  
 Amortisation charge for the year           335    363    
 Impairment charge for the year             78     -      
 At 31 December                             4,261  3,848  
 Net book amount at 31 December             1,330  1,743  
 
 
For intangible assets regarded as having a finite useful life, amortisation
commences when products underpinned by the intellectual property rights become
available for use. Amortisation is calculated on a straight line basis over
the remaining patent life of the asset. Amortisation of £335,000 (2015:
£363,000) is included in 'Research, development and bioprocessing' in the
statement of comprehensive income. 
 
6   Property, plant and equipment 
 
                                      Freehold property  Shortleasehold  improve-ments  Office equipment and computers  Manufac-turing and Laboratory equipment  Assets under constru-ction1  Total    
                                      £'000              £'000                          £'000                           £'000                                    £'000                        £'000    
 Cost                                                                                                                                                                                                  
 At 1 January 2016                    6,938              7,397                          1,374                           7,574                                    9,744                        33,027   
 Additions at cost                    -                  206                            506                             1,526                                    4,220                        6,458    
 Reclassifications                    13,964             -                              -                               -                                        (13,964)                     -        
 Disposals                            -                  (633)                          (229)                           (2,612)                                  -                            (3,474)  
 At 31 December 2016                  20,902             6,970                          1,651                           6,488                                    -                            36,011   
                                                                                                                                                                                                       
 Accumulated depreciation                                                                                                                                                                              
 At 1 January 2016                    921                2,909                          753                             4,048                                    -                            8,631    
 Charge for the year                  1,385              522                            353                             1,080                                    -                            3,340    
 Disposals                            -                  (633)                          (229)                           (2,612)                                  -                            (3,474)  
 At 31 December 2016                  2,306              2,798                          877                             2,516                                    -                            8,497    
 Net book amount at 31 December 2016  18,596             4,172                          774                             3,972                                    -                            27,514   
 
 
                                      Freehold property  Shortleasehold  improve-ments  Office equipment and computers  Manufac-turing and Laboratory equipment  Assets under constru-ction1  Total   
                                      £'000              £'000                          £'000                           £'000                                    £'000                        £'000   
 Cost                                                                                                                                                                                                 
 At 1 January 2015                    6,887              2,623                          820                             5,335                                    646                          16,311  
 Additions at cost                    51                 863                            554                             2,239                                    13,009                       16,716  
 Disposals                            -                  3,911                          -                               -                                        (3,911)                      -       
 At 31 December 2015                  6,938              7,397                          1,374                           7,574                                    9,744                        33,027  
                                                                                                                                                                                                      
 Accumulated depreciation                                                                                                                                                                             
 At 1 January 2015                    698                2,579                          595                             3,495                                    -                            7,367   
 Charge for the year                  223                330                            158                             553                                      -                            1,264   
 At 31 December 2015                  921                2,909                          753                             4,048                                    -                            8,631   
 Net book amount at 31 December 2015  6,017              4,488                          621                             3,526                                    9,744                        24,396  
 
 
1      Assets under construction represent the capitalisation of construction
works at the Harrow House and Yarnton manufacturing facilities, and the
Windrush Court laboratories. 
 
7   Investments 
 
On 29 November 2016, as part of a strategic alliance with Orchard
Therapeutics, the Group received a 1.95 % equity stake in Orchard. This
investment has been classified at fair value through the profit & loss (2016:
£657,000; 2015: £nil). As Orchard Therapeutics is a private company, the
equity investment has not been valued based on observable market data. 
 
8   Inventories 
 
                   2016   2015   
                   £'000  £'000  
 Raw Materials     2,120  2,217  
 Work in progress  82     489    
 Total inventory   2,202  2,706  
 
 
Inventories constitute raw materials held for commercial bioprocessing
purposes, and work-in-progress inventory related to contractual bioprocessing
obligations. 
 
During 2016, the Group wrote down £29,000 of inventory which is not expected
to be used in production or sold onwards. 
 
9   Trade and other receivables 
 
                                        2016   2015    
                                        £'000  £'000   
 Trade receivables                      1,969  7,374   
 Accrued income                         2,919  1,155   
 Other receivables                      238    31      
 Other tax receivable                   1,330  1,522   
 Prepayments                            448    848     
 Total trade and other receivables      6,904  10,930  
 
 
The fair value of trade and other receivables are the current book values. 
 
Included in the Group's trade receivable balance are debtors with a carrying
amount of £47,000 (2015: £826,000) which were past due at the reporting date,
all of which have since been received. 
 
10 Trade and other payables 
 
                                         2016   2015   
                                         £'000  £'000  
 Trade payables                          1,576  3,588  
 Other taxation and social security      442    384    
 Accruals                                3,985  5,314  
 Total trade and other payables          6,003  9,286  
 
 
11 Deferred income 
 
Deferred income arises when the Group has received payment for services in
excess of the stage of completion of the service being provided. 
 
12 Loans 
 
In May 2015, the Group entered into the $50 million Oberland Facility. The
Group has used $40 million (£26.1 million) of the facility to finance the
Group's expansion of its bioprocessing and laboratory capacity in order to
enable it to deliver on commitments under its bioprocessing agreement with
Novartis. The Group drew down $25 million (£16.3 million) of the loan in May
2015 and a further $15 million (£9.8 million) in September 2015 to ensure
adequate finance for the ongoing capacity expansion programme. The remaining
funds under the Oberland Facility are available to be drawn down in minimum
tranches of $5 million at the Group's option prior to 31 March 2017 and the
proceeds of such drawdowns may be used only for certain permitted acquisitions
and licensing activities as approved by Oberland in its sole discretion. The
Oberland Facility is repayable not later than 1 May 2022 and may be prepaid at
any time. Over the course of the loan term, interest is payable quarterly at
an annual interest rate of 9.5 per cent. plus the greater of 1 per cent. and
three month LIBOR. Under the terms of the Oberland Facility, loans are issued
at an original discount of 2.5 per cent. In addition to interest, a repayment
fee is also payable upon any repayment including on exit. Oxford BioMedica
will also pay an additional amount of 0.35 per cent. of its annual worldwide
net revenue, as calculated from the Group's financial statements, from 1 April
2017 to 31 December 2025 for each $5 million of loan drawn down over $30
million. This revenue participation may be retired at any time upon payment of
an exit fee. In the event that the loan is repaid after the second anniversary
there may be a true-up payment payable to Oberland in the event that the
aggregate of the interest payments, revenue participation payments and exit
fee do not in aggregate provide a return of 15 per cent. per annum to
Oberland. The outstanding balance at year end is £34.4 million (2015: £27.3
million). 
 
The Group is required to maintain a cash balance not less than $10 million
(approximately £8.1 million) while the Oberland Facility is outstanding. The
Oberland Facility is secured by a pledge over substantially all of the Group's
assets. Drawdowns of additional tranches are subject to certification by
Oxford BioMedica that representations and warranties under the Oberland
Facility agreement remain true and correct as of the drawdown date, and
certifications relating to no default or material adverse effect. 
 
In 2013, the Group was awarded a funding package of £7.1 million under the UK
Government's Advanced Manufacturing Supply Chain Initiative. Of this package,
£5.3 million was a loan facility bearing interest at 6 per cent., and £1.8
million was in the form of grant finance. In April 2014, the Group drew down
£1 million from the AMSCI facility. In March 2015, the Group drew down a
further £2 million from the AMSCI facility. During May 2015, the loan facility
was terminated and the outstanding balance was repaid. 
 
13 Provisions 
 
                                      Dilapidations£'000  
 At 1 January 2016                    1,371               
 Unwinding of discount                5                   
 Utilisation of provision             (833)               
 Additional provision recognised      79                  
 At 31 December 2016                  622                 
                                                          
 At 1 January 2015                    535                 
 Unwinding of discount                3                   
 Additional provision recognised      833                 
 At 31 December 2015                  1,371               
 
 
The dilapidations provision relates to anticipated costs of restoring the
leasehold Medawar and Yarnton properties in Oxford, UK to their original
condition at the end of leases in 2016 and 2024 respectively, discounted using
the rate per the Bank of England nominal yield curve. The equivalent rate was
used in 2015. The provisions will be utilised at the end of the leases if they
are not renewed, and for that reason, the provision in respect of the Medawar
Centre was released in 2016 at the end of the lease. 
 
14 Cash flows from operating activities 
 
Reconciliation of loss before tax to net cash used in operations: 
 
                                                           2016      2015      
                                                           £'000     £'000     
 Continuing operations                                                         
 Operating loss                                            (11,313)  (14,083)  
 Adjustment for:                                                               
 Depreciation                                              3,340     1,264     
 Amortisation of intangible assets                         335       363       
 Charge for impairment                                     78        -         
 Charge in relation to employee share schemes              865       730       
 Non-cash revenues                                         (657)     -         
 Changes in working capital:                                                   
 Decrease / (increase) in trade and other receivables      4,026     (5,777)   
 (Decrease) / increase in trade and other payables         (3,283)   2,982     
 Increase in deferred income                               268       118       
 (Decrease) / increase in provisions                       (749)     836       
 Increase in investments                                   657       -         
 Decrease / (Increase) in inventory                        504       (1,299)   
 Net cash used in operations                               (5,929)   (14,866)  
 
 
This information is provided by RNS
The company news service from the London Stock Exchange

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