RedHill Biopharma Reports First Quarter 2019 Financial Results and Operational Highlights
Key Highlights and Upcoming Milestones:
- NDA submitted to the
FDAfor Talicia® for H. pylori infection, with potential U.S. commercial launch in Q4/2019, assuming FDAapproval FDAmeeting planned for H2/2019 to discuss design of confirmatory Phase 3 study and path to potential approval for RHB-104 for Crohn’s disease
- Initiation of pivotal Phase 3 study expected in H2/2019 with RHB-204 for first-line treatment of pulmonary nontuberculous mycobacteria (NTM) infections
- Net revenues of
$1.7 million, an increase of 28% over previous quarter
- Debt-free balance sheet with
$45.5 millionin cash as of March 31, 2019, with quarterly cash burn at its lowest in two years
“We had a productive quarter with Talicia leading up to the NDA submission to the
Talicia (RHB-105)1- Eradication of H. pylori Infection
RedHill submitted a New Drug Application (NDA) to the
RedHill announced in
RHB-104 - Crohn’s Disease
RedHill plans to meet with the
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Infections
RedHill plans to initiate a pivotal Phase 3 study with RHB-204 for the treatment of pulmonary NTM infections in the second half of 2019, subject to completion of the ongoing supportive non-clinical program and additional input from the
BEKINDA® (RHB-102)1 - Gastroenteritis and Gastritis and Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
RedHill is currently working toward a confirmatory Phase 3 study to support a potential NDA for BEKINDA® for acute gastroenteritis and gastritis. This study follows the successful completion of a first Phase 3 study with BEKINDA for acute gastroenteritis and gastritis and guidance provided by the
RedHill held a positive end-of-Phase 2 Type B meeting with the
YELIVA® (opaganib, ABC294640)1 - Cholangiocarcinoma
The ongoing Phase 2a study evaluating the activity of orally-administered YELIVA in advanced cholangiocarcinoma (bile duct cancer) continues to enroll patients in the second stage of the two-stage study design. Enrollment of the full cohort of 39 evaluable patients is expected to be completed by the end of 2019.
RedHill is continuing its preparations for the potential U.S. launch of Talicia in the fourth quarter of 2019 with its dedicated sales force. RedHill currently commercializes and promotes several GI-specialty products in select U.S. territories, including Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)2, EnteraGam® (serum-derived bovine immunoglobulin/protein isolate SBI)3 and Mytesi® (crofelemer 125 mg delayed-release tablets)4.
Financial highlights for the quarter ended March 31, 20195
- Net Revenues of
$1.7 millionin the first quarter of 2019, an increase of 28% compared to the fourth quarter of 2018. The growth was attributable to an increase in revenues from promoted products.
- Gross Profit of
$1.3 millionin the first quarter of 2019, compared to $0.8 millionin the fourth quarter of 2018, with gross margin increased from 57% to 76%. The growth was attributable to an increase in revenues from promoted products.
- Research and Development Expenses of
$5.4 millionin the first quarter of 2019, compared to $5.8 millionin the fourth quarter of 2018, resulting from the successful finalization of the confirmatory Phase 3 study with Talicia.
- Selling, Marketing and Business Development Expenses of
$3.1 millionin the first quarter of 2019, compared to $3.2 millionin the fourth quarter of 2018.
- General and Administrative Expenses of
$2.0 millionin the first quarter of 2019, compared to $1.9 millionin the fourth quarter of 2018.
- Operating Loss of
$9.2 millionin the first quarter of 2019, compared to $10 millionin the fourth quarter of 2018. The decrease in Operating Loss was primarily due to the increase in Gross Profit and the decrease in Research and Development Expenses, as described above.
- Net Cash Used in Operating Activities of
$7.5 millionin the first quarter of 2019, compared to $8.2 millionin the fourth quarter of 2018.
- Cash Balance6 as of
March 31, 2019, was $45.5 million, compared to $53.2 millionas of December 31, 2018.
Conference Call and Webcast Information:
The Company will host a conference call today,
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call:
About RedHill Biopharma Ltd.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its therapeutic candidates; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully commercialize and promote Donnatal®, EnteraGam®, Mytesi® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the
Senior VP Business Development & Licensing
|IR contact (U.S.):
Timothy McCarthy, CFA, MBA
Managing Director, Relationship Manager
LifeSci Advisors, LLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|Three Months Ended|
|U.S. dollars in thousands|
|COST OF REVENUES||417||930|
|RESEARCH AND DEVELOPMENT EXPENSES, net||5,372||6,416|
|SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES||3,136||3,170|
|GENERAL AND ADMINISTRATIVE EXPENSES||2,025||1,924|
|FINANCIAL EXPENSES (INCOME), net||657||(60||)|
|LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD||9,870||9,935|
|LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars)||0.03||0.05|
|WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands)||283,687||213,192|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
|March 31,||December 31,|
|U.S. dollars in thousands|
|Cash and cash equivalents||23,014||29,005|
|Financial assets at fair value through profit or loss||16,374||15,909|
|Prepaid expenses and other receivables||1,243||1,876|
|Accrued expenses and other current liabilities||6,962||7,057|
|Derivative financial instruments||1,317||344|
|Additional paid-in capital||219,505||219,505|
|TOTAL LIABILITIES AND EQUITY||58,134||62,411|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
|Three Months Ended|
|U.S. dollars in thousands|
|Adjustments in respect of income and expenses not involving cash flow:|
|Share-based compensation to employees and service providers||559||806|
|Fair value adjustments on derivative financial instruments||973||(50||)|
|Fair value losses (gains) on financial assets at fair value through profit or loss||(52||)||99|
|Revaluation of bank deposits||(10||)||90|
|Exchange differences in respect of lease liabilities||5||—|
|Exchange differences in respect of cash and cash equivalents||(16||)||14|
|Changes in assets and liability items:|
|Increase in trade receivables||(461||)||(281||)|
|Decrease in prepaid expenses and other receivables||633||1,271|
|Decrease (increase) in inventory||(519||)||93|
|Increase (decrease) in accounts payable||1,089||(2,081||)|
|Increase (decrease) in accrued expenses and other current liabilities||(95||)||456|
|Net cash used in operating activities||(7,533||)||(9,496||)|
|Purchase of fixed assets||(6||)||(13||)|
|Change in investment in current bank deposits||2,131||(131||)|
|Purchase of financial assets at fair value through profit or loss||(633||)||(1,046||)|
|Proceeds from sale of financial assets at fair value through profit or loss||220||1,950|
|Net cash provided by investing activities||1,712||760|
|Exercise of options into ordinary shares||—||355|
|Principal elements of lease payments||(186||)||—|
|Repayment of payable in respect of intangible asset purchase||—||(500||)|
|Net cash used in financing activities||(186||)||(145||)|
|DECREASE IN CASH AND CASH EQUIVALENTS||(6,007||)||(8,881||)|
|EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS||16||(14||)|
|BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD||29,005||16,455|
|BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD||23,014||7,560|
|SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH||163||267|
|SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING ACTIVITIES|
|Acquisition of right-of-use assets by means of lease liabilities||1,580||—|
1 Talicia® (RHB-105), BEKINDA® (RHB-102) and YELIVA® (opaganib, ABC294640) are investigational new drugs, not available for commercial distribution.
2 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. For more information, please see the prescribing information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.
3 EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a commercially-available medical food, intended for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, which must be administered under medical supervision.
4 Mytesi® (crofelemer 125 mg delayed-release tablets) is a first-in-class anti-secretory prescription drug approved by the U.S.
5 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
6 Including cash and short-term investments (bank deposits and financial assets at fair value).
Source: RedHill Biopharma Ltd.