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BioLineRx Reports Third Quarter 2016 Financial Results

TEL AVIV, Israel, Nov. 22, 2016 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, today reports its financial results for the third quarter ended September 30, 2016.

Highlights and achievements during third quarter of 2016 and to date:

  • Signing of significant immuno-oncology collaboration with Genentech, a member of the Roche Group, for several Phase 1b studies for BL-8040 in combination with Genentech's Atezolizumab, in multiple solid tumor indications and AML
  • Steady progress in existing immuno-oncology collaboration with MSD (known as Merck in the US and Canada), with initiation of a Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA®
  • Signing of immuno-oncology collaboration with MD Anderson Cancer Center for additional Phase 2a combination study in pancreatic cancer, as part of strategic clinical research immunotherapy collaboration between MSD and MD Anderson Cancer Center
  • In-licensing of three new projects under strategic collaboration with Novartis, including two novel liver fibrosis/failure projects, and a novel anti-inflammatory treatment for dry eye syndrome
  • Presentation of growing body of clinical evidence surrounding BL-8040 at leading medical and scientific conferences, including an oral presentation at the upcoming ASH 2016
  • Expanded geographic reach with new joint venture in China for development of novel drug candidates

Expected upcoming significant milestones for 2017:

  • Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by Q1 2017
  • Partial results in immuno-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA® expected by H2 2017 
  • Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech's Atezolizumab, in multiple solid tumor indications and AML, expected to commence during 2017

Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "The third quarter of 2016 demonstrated our continued ability to leverage our leading BL-8040 oncology platform, as well as our access to cutting edge technologies. In particular, our immunotherapy collaboration efforts continued to bear fruit, with the signing of a significant agreement with Genentech to carry out multiple clinical trials in a variety of oncology indications, as well as a collaboration agreement with MD Anderson Cancer Center.  Meanwhile, our immunotherapy collaboration with Merck, announced earlier in the year, steadily progressed, with our Phase 2a clinical trial in pancreatic cancer now in active enrollment.  Further, following extensive due diligence, we are now pleased to roll out three programs under our Novartis collaboration, including two in the exciting field of liver fibrosis. We expect a number of additional novel assets to enter our pipeline in 2017, including several within the framework of the Novartis collaboration. Finally, we continue to highlight growing clinical evidence supporting our lead oncology program, BL-8040, which is regularly featured at leading medical and scientific conferences."

"We are excited about our prospects ahead and are focused on achieving our expected milestones for 2017 and beyond. With $39 million of cash on hand, we remain well positioned to carry out our operational plans for the next few years," Mr. Serlin concluded.

Financial Results for the Third Quarter Ended September 30, 2016

Research and development expenses for the three months ended September 30, 2016 were $3.0 million, an increase of $0.4 million, or 14.7%, compared to $2.6 million for the comparable period in 2015. The increase resulted primarily from spending on new projects and from increased spending on BL-8040 in the 2016 period. Research and development expenses for the nine months ended September 30, 2016 were $8.2 million, a decrease of $0.4 million, or 5.1%, compared to $8.7 million for the comparable period in 2015. The decrease resulted primarily from lower expenditures for BL-7010 during the 2016 period and conclusion of one of the clinical trials for BL-8040 in 2015, partially offset by increased spending on a new project.

Sales and marketing expenses for the three months ended September 30, 2016 were $0.41 million, an increase of $0.14 million, or 54.3%, compared to $0.27 million for the comparable period in 2015. The increase resulted primarily from consultancy and legal expenses related to increased business development activity in the 2016 period. Sales and marketing expenses for the nine months ended September 30, 2016 were $0.9 million, an increase of $0.1 million, or 12.6%, compared to $0.8 million for the nine months ended September 30, 2015. The reason for the increase is similar to the one discussed above in the three-month comparison.

General and administrative expenses for the three months ended September 30, 2016 were $1.1 million, an increase of $0.4 million, or 47.6%, compared to $0.8 million for the comparable period in 2015. The increase resulted primarily from an increase in non-cash share-based compensation. General and administrative expenses for the nine months ended September 30, 2016 were $3.0 million, an increase of $0.4 million, or 14.4%, compared to $2.6 million for the nine months ended September 30, 2015. The reason for the increase is similar to the one discussed above in the three-month comparison.

The Company's operating loss for the three months ended September 30, 2016 amounted to $4.5 million, compared with an operating loss of $3.6 million for the corresponding 2015 period. The Company's operating loss for the nine months ended September 30, 2016 amounted to $12.1 million, similar to the comparable period in 2015.

Non-operating income (expenses) for the three and nine months ended September 30, 2016 and 2015 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet. These fair-value adjustments, which were material in the 2015 periods, but not material in the 2016 periods, are highly influenced by the Company's share price at each period end (revaluation date).

Net financial income (expenses) for the three and nine months ended September 30, 2016 and 2015 primarily relate to investment income earned on bank deposits, as well as banking fees.

The Company's net loss for the three months ended September 30, 2016 amounted to $4.3 million, compared with a net loss of $1.6 million for the corresponding 2015 period. The Company's net loss for the nine months ended September 30, 2016 amounted to $11.6 million, compared with a net loss of $10.7 million for the corresponding 2015 period.

The Company held $38.9 million in cash, cash equivalents and short-term bank deposits as of September 30, 2016.

Net cash used in operating activities was $10.4 million for the nine months ended September 30, 2016, compared with net cash used in operating activities of $11.0 million for the comparable period in 2015. The $0.6 million decrease in net cash used was primarily the result of an increase in other receivables.

Net cash provided by investing activities for the nine months ended September 30, 2016 was $7.3 million, compared to net cash used in investing activities of $18.7 million for the comparable period in 2015. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the nine months ended September 30, 2016 was $1.5 million, compared to net cash provided by financing activities of $29.3 million for the comparable period in 2015. The decrease in cash flows from financing activities reflects the underwritten public offering which was completed in March 2015.

Conference Call and Webcast Information

BioLineRx will hold a conference call to discuss its third quarter end September 30, 2016 results today, November 22, 2016, at 10:00 a.m. EST. To access the conference call, please dial 1-866-744-5399 from the US, or +972-3-918-0692 internationally. The call will also be available via live webcast through BioLineRx's website, www.biolinerx.com. A replay of the conference call will be available approximately two hours after completion of the live conference call. To access the replay, please dial 1-866-276-1485 from the US or +972-3-925-5944 internationally. The replay will be available through November 25, 2016.

(Tables follow)

 About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds, primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment, and has recently initiated a Phase 2 study in stem cell mobilization for allogeneic transplantation; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada) to run a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck's KEYTRUDA®; and has recently signed a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's Atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML.

For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2016. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

 

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)






December 31,


September 30,


2015


2016


in USD thousands

Assets




CURRENT ASSETS




Cash and cash equivalents

5,544


4,014

Short-term bank deposits

42,119


34,894

Prepaid expenses

229


203

Other receivables

291


303

          Total current assets

48,183


39,414





NON-CURRENT ASSETS




Long-term prepaid expenses

58


54

Property and equipment, net

2,909


2,654

Intangible assets, net

152


155

          Total non-current assets

3,119


2,863

          Total assets

51,302


42,277





Liabilities and equity




CURRENT LIABILITIES




Current maturities of long-term bank loan

93


93

Accounts payable and accruals:




     Trade

1,910


2,274

     Other

1,137


1,000

          Total current liabilities

3,140


3,367

NON-CURRENT LIABILITIES




Long-term bank loan, net of current maturities

344


272

Warrants

208


29

          Total non-current liabilities

552


301

COMMITMENTS AND CONTINGENT LIABILITIES




     Total liabilities

3,692


3,668





EQUITY




Ordinary shares

1,455


1,460

Share premium

196,201


198,380

Other comprehensive loss

(1,416)


(1,416)

Capital reserve

10,735


11,106

Accumulated deficit

(159,365)


(170,921)

          Total equity

47,610


38,609

          Total liabilities and equity

51,302


42,277

 


 


BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)



Three months ended
September 30,

Nine months ended
September 30,


2015



2016


2015


2016


in USD thousands

in USD thousands

RESEARCH AND DEVELOPMENT EXPENSES, NET

(2,576)


(2,954)


(8,678)


(8,233)

SALES AND MARKETING EXPENSES

(265)


(409)


(824)


(928)

GENERAL AND ADMINISTRATIVE EXPENSES

(762)


(1,125)


(2,594)


(2,968)

OPERATING LOSS

(3,603)


(4,488)


(12,096)


(12,129)

NON-OPERATING INCOME (EXPENSES), NET

1,983


(14)


1,096


182

FINANCIAL INCOME

85


172


363


403

FINANCIAL EXPENSES

(91)


(4)


(111)


(12)









NET LOSS AND COMPREHENSIVE LOSS

(1,626)


(4,334)


(10,748)


(11,556)




in USD

in USD

LOSS PER ORDINARY SHARE - BASIC AND DILUTED

(0.03)


(0.08)


(0.21)


(0.21)









WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE

54,632,788


56,426,202


50,306,892


55,912,486


 

 

BioLineRx Ltd.

CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)



Ordinary shares


Share premium


Other
comprehensive
loss


Capital reserve


Accumulated deficit


Total


in USD thousands

BALANCE AT JANUARY 1, 2015

1,055


167,331


(1,416)


9,800


(144,965)


31,805

CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2015:












Issuance of share capital, net

395


28,449


-


-


-


28,844

Employee stock options forfeited and expired



170




(170)




-

Share-based compensation              

-


-


-


770


-


770

Comprehensive loss for the period

-


-


-


-


(10,748)


(10,748)

BALANCE AT SEPTEMBER 30, 2015

1,450


195,950


(1,416)


10,400


(155,713)


50,671


























Ordinary shares


Share premium


Other
comprehensive
loss


Capital reserve


Accumulated deficit


Total


in USD thousands

BALANCE AT JANUARY 1, 2016

1,455


196,201


(1,416)


10,735


(159,365)


47,610

CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2016:












Issuance of share capital, net

4


1,591


-


-


-


1,595

Employee stock options exercised

1


128


-


(128)


-


1

Employee stock options forfeited and expired

-


460


-


(460)


-


-

Share-based compensation              

-


-


-


959


-


959

Comprehensive loss for the period

-


-


-


-


(11,556)


(11,556)

BALANCE AT SEPTEMBER 30, 2016

1,460


198,380


(1,416)


11,106


(170,921)


38,609













 

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)



Nine months ended

September 30,


2015

2016


in USD thousands




CASH FLOWS - OPERATING ACTIVITIES



Comprehensive loss for the period

(10,748)

(11,556)

Adjustments required to reflect net cash used in operating activities (see
appendix below)

(232)

1,128

Net cash used in operating activities

(10,980)

(10,428)




CASH FLOWS - INVESTING ACTIVITIES



Investments in short-term deposits

(51,262)

(28,978)

Maturities of short-term deposits

34,878

36,480

Maturities of restricted deposits

166

-

Purchase of property and equipment

(2,466)

(164)

Purchase of intangible assets

(22)

(24)

Net cash provided by (used in) investing activities

(18,706)

7,314




CASH FLOWS - FINANCING ACTIVITIES



Issuances of share capital, net

28,844

1,595

Proceeds of bank loan

467

-

Repayments of bank loan

(8)

(72)

Proceeds from exercise of employee stock options

-

1

Net cash provided by financing activities

29,303

1,524




DECREASE IN CASH AND CASH EQUIVALENTS

(383)

(1,590)

CASH AND CASH EQUIVALENTS – BEGINNING

   OF PERIOD

5,790

5,544

EXCHANGE DIFFERENCES ON CASH AND CASH
EQUIVALENTS

(87)

60

CASH AND CASH EQUIVALENTS - END OF PERIOD

5,320

4,014




 

 

BioLineRx Ltd.

APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)



Nine months ended
September 30,


2015


2016


in USD thousands









Adjustments required to reflect net cash used in operating activities:




Income and expenses not involving cash flows:




Depreciation and amortization

322


368

Long-term prepaid expenses

(7)


4

Interest and exchange rate differences on short-term deposits

(113)


(277)

Share-based compensation

770


959

Exchange differences on cash and cash equivalents

87


(60)

Gain on adjustment of warrants to fair value

(1,096)


(179)


(37)


815





Changes in operating asset and liability items:




Decrease (Increase) in prepaid expenses and other receivables

(700)


14

Increase in accounts payable and accruals

505


299


(195)


313


(232)


1,128





Supplementary information on investing activities not

    involving cash flows:




    Property and equipment acquired on supplier trade credit

228


-





Supplementary information on interest received in cash

105


310





 

Contact:
PCG Advisory
Vivian Cervantes
Investor Relations
212-554-5482
vivian@pcgadvisory.com

or

Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/biolinerx-reports-third-quarter-2016-financial-results-300367271.html

SOURCE BioLineRx Ltd.


Interview with Philip Serlin, CEO
December 2016