RedHill Biopharma Reports 2016 Third Quarter Financial Results
GlobeNewswire•November 14, 2016
RedHill maintains a debt-free balance sheet with $40.5 million in cash at the end of the third quarter, allowing the Company to continue to diligently execute its three ongoing Phase III gastrointestinal disease programs and other clinical-stage programs
Recent key milestones include:
Enhancement of the RHB-104 Phase III Crohn’s disease program, including the introduction of an option for early stop for success for overwhelming efficacy, expected in Q2/2017
Initiation of Phase II studies with YELIVA™ for multiple myeloma and hepatocellular carcinoma
Signing of an exclusive license agreement with Grupo JUSTE for the commercialization in Spain of RIZAPORT® oral thin-film migraine drug and filing of a national Marketing Authorization Application in Spain by Grupo JUSTE
Signing of a binding term sheet with Pharmatronic Co. for the commercialization of RIZAPORT® in South Korea
Enhancement of the RHB-104 Phase III Crohn’s disease program, including the introduction of an option for early stop for success for overwhelming efficacy, expected in Q2/2017
Initiation of Phase II studies with YELIVA™ for multiple myeloma and hepatocellular carcinoma
Signing of an exclusive license agreement with Grupo JUSTE for the commercialization in Spain of RIZAPORT® oral thin-film migraine drug and filing of a national Marketing Authorization Application in Spain by Grupo JUSTE
Signing of a binding term sheet with Pharmatronic Co. for the commercialization of RIZAPORT® in South Korea
Potential milestones expected in the coming year include:
Q4/2016 - Safety-focused independent data and safety monitoring board (DSMB) meeting for the MAP US Phase III study with RHB-104 for Crohn’s disease
Q4/2016 - Top-line final results from the ongoing Phase IIa CEASE-MS study with RHB-104 for multiple sclerosis
Q2/2017 - Independent DSMB evaluation of the MAP US Phase III study with RHB-104 for Crohn’s disease, including option for early stop for success for overwhelming efficacy
H1/2017 - Initiation of a confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection
Mid-2017 - Top-line results from the ongoing Phase III study with BEKINDA® for gastroenteritis and gastritis in the U.S. (the GUARD study)
Mid-2017 - Top-line results from the ongoing Phase II study with BEKINDA® for diarrhea-predominant irritable bowel syndrome (IBS-D) in the U.S.
H1/ 2017 - Re-submission of the RIZAPORT® U.S. NDA to the FDA
Q4/2016 - Safety-focused independent data and safety monitoring board (DSMB) meeting for the MAP US Phase III study with RHB-104 for Crohn’s disease
Q4/2016 - Top-line final results from the ongoing Phase IIa CEASE-MS study with RHB-104 for multiple sclerosis
Q2/2017 - Independent DSMB evaluation of the MAP US Phase III study with RHB-104 for Crohn’s disease, including option for early stop for success for overwhelming efficacy
H1/2017 - Initiation of a confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection
Mid-2017 - Top-line results from the ongoing Phase III study with BEKINDA® for gastroenteritis and gastritis in the U.S. (the GUARD study)
Mid-2017 - Top-line results from the ongoing Phase II study with BEKINDA® for diarrhea-predominant irritable bowel syndrome (IBS-D) in the U.S.
H1/ 2017 - Re-submission of the RIZAPORT® U.S. NDA to the FDA
TEL-AVIV, Israel, Nov. 14, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (RDHL) (RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today reported its financial results for the quarter ended September 30, 2016.
The Company will host a conference call on Monday, November 14, 2016, at 9:00 am EST to review the financial results and business highlights, dial-in details are included below.
Financial highlights for the quarter ended September 30, 20161
Research and Development Expenses for the third quarter of 2016 were $7.0 million, an increase of $3.1 million, compared to $3.9 million in the third quarter of 2015 and an increase of $1.0 million, compared to $6.0 million in the second quarter of 2016. Research and Development Expenses for the nine months ended September 30, 2016 were $17.7 million, an increase of $4.9 million, compared to $12.8 million in the comparable period of 2015. The increase in 2016 resulted primarily from the ongoing Phase III MAP US study with RHB-104 (Crohn's disease), the ongoing Phase II and Phase III studies with BEKINDA® (IBS-D and gastroenteritis, respectively) and from preparations for several Phase I/II studies with YELIVA™ for multiple indications.
General, Administrative and Business Development Expenses in the third quarter of 2016 were $1.4 million, an increase of $0.7 million, compared to $0.7 million in the third quarter of 2015 and an increase of $0.2 million, compared to $1.2 million in the second quarter of 2016. General, Administrative and Business Development Expenses for the nine months ended September 30, 2016 were $3.8 million, an increase of $1.4 million, compared to $2.4 million in the comparable period of 2015. The increase was mainly due to enhanced business development and investor relations activities.
Operating Loss in the third quarter of 2016 was $8.5 million, an increase of $3.9 million, compared to $4.6 million in the third quarter of 2015 and an increase of $1.3 million, compared to $7.2 million in the second quarter of 2016. Operating Loss for the nine months ended September 30, 2016 were $21.6 million, an increase of $6.4 million, compared to $15.2 million in the comparable period of 2015. The increase was mainly due to increases in Research and Development Expenses, as detailed above.
Net Cash Used in Operating Activities in the third quarter of 2016 was $7.4 million, an increase of $3.7 million, compared to $3.7 million in the third quarter of 2015 and an increase of $1.7 million, compared to $5.7 million in the second quarter of 2016. Net Cash Used in Operating Activities for the nine months ended September 30, 2016 was $18.1 million, an increase of $6.3 million, compared to $11.8 million in the comparable period of 2015. The increase mainly reflects the increase in Operating Loss, as detailed above.
Net Cash Used in Investment Activities in the third quarter of 2016 was $10.7 million, compared to Net Cash Used in Investment Activities of $2.4 million in the third quarter of 2015. Net Cash Used in Investment Activities for the nine months ended September 30, 2016 was $3.2 million, an increase of $4.3 million, compared to Net Cash Provided by Investment Activities of $1.1 million in the comparable period of 2015. The increase in Net Cash Used in Investment Activities was due to an increase in bank deposits and marketable securities in 2016.
Cash Balance2 as of September 30, 2016 was $40.5 million, a decrease of $17.6 million, compared to $58.1 million as of December 31, 2015. The decrease was a result of the ongoing operations, mainly related to research and development activities.
“We are very pleased with the important operational milestones achieved during this quarter, including the significant enhancements to the RHB-104 Phase III development program for Crohn’s disease and the initiation of several clinical studies with our novel Phase II oncology drug YELIVA™” said Mr. Micha Ben Chorin, RedHill’s CFO. “We maintained a debt-free balance sheet and a cash position of $40.5 million at the end of the third quarter of 2016 as we continue to advance several Phase III and Phase II gastrointestinal programs toward important data points in the coming months. We also continue to advance our strategic plan to build a U.S. specialty GI pharmaceutical company.”
