DGAP-News: RedHill Biopharma Ltd. / Key word(s): Quarter Results
RedHill Biopharma Ltd.: RedHill Biopharma Reports 2016 First Quarter
Financial Results
02.05.2016 / 10:00
The issuer is solely responsible for the content of this announcement.
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Press Release
RedHill Biopharma Reports 2016 First Quarter Financial Results
- RedHill maintains a strong and debt-free balance sheet with
approximately $53 million in cash at the end of the first quarter,
allowing the Company to continue to diligently execute its strategic
and operational plans, including its three ongoing Phase III
gastrointestinal disease programs in the U.S.
- Key milestones in the first quarter of 2016 include:
- Initiation of a Phase II study with BEKINDA(TM) for
diarrhea-predominant irritable bowel syndrome (IBS-D)
- Receipt of encouraging top-line interim results from a Phase IIa
study with RHB-104 for multiple sclerosis
- Receipt of final results from the successful first Phase III study
with RHB-105 for treatment of H. pylori infection
- A binding commercialization term-sheet for RIZAPORT(TM) for
migraines in Spain
- Upcoming milestones expected in the second half of 2016 include:
- Initiation of a confirmatory Phase III study with RHB-105 for
treatment of H. pylori infection following a positive meeting with
the FDA, announced earlier this week
- Top-line results from the ongoing Phase III study with BEKINDA(TM)
for gastroenteritis
- Interim DSMB analysis of the RHB-104 ongoing Phase III study for
Crohn's disease
TEL-AVIV, Israel, May 02, 2016 RedHill Biopharma Ltd. (NASDAQ; RDHL)
(TASE: 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
inflammatory and gastrointestinal diseases, including cancer, today
reported its financial results for the quarter ended March 31, 2016.
Financial highlights for the quarter ended March 31, 2016:
Research and Development Expenses in the first quarter of 2016 were
approximately $4.7 million, an increase of approximately $0.9 million,
compared to approximately $3.8 million in the first quarter of 2015. The
increase resulted primarily from clinical trial costs related to the
ongoing Phase III MAP US clinical study with RHB-104 (Crohn's disease) and
the preparations for several Phase II studies with YELIVA(TM) for multiple
oncology, inflammatory and gastrointestinal indications.
General and Administrative Expenses in the first quarter of 2016 were
approximately $1.2 million, an increase of approximately $0.3 million,
compared to approximately $0.9 million in the first quarter of 2015. The
increase was mainly due to professional fees associated with business
development activities, intellectual property costs and share-based
compensation costs.
Operating Loss in the first quarter of 2016 was approximately $5.9 million,
an increase of approximately $1.1 million, compared to approximately $4.8
million in the first quarter of 2015. The increase was mainly in Research
and Development Expenses and General and Administrative Expenses.
Net Cash Used in Operating Activities in the first quarter of 2016 was
approximately $5.0 million, an increase of approximately $1.6 million,
compared to approximately $3.4 million in the first quarter of 2015. The
increase was mainly a result of an increase in research and development
activities.
Net Cash Used in Investment Activities in the first quarter of 2016 was
approximately $4.6 million, a decrease of approximately $2.5 million,
compared to approximately $7.1 million in the first quarter of 2015. The
decrease was mainly in bank deposit investments.
Cash Provided by Financing Activities in the first quarter of 2016 was
immaterial, compared to approximately $13.2 million in the first quarter of
2015, resulting from a public offering in February 2015 in the U.S.
Cash Balance as of March 31, 2016 was approximately $53.4 million, a
decrease of approximately $5 million, compared to approximately $58.4
million as of December 31, 2015. The decrease was a result of the ongoing
operations, mainly related to research and development activities.
Micha Ben Chorin, RedHill's CFO, said: "We made significant progress with
our advanced clinical programs during the first quarter of 2016 and are
excited about the potential milestones expected during the second half of
2016, including the interim DSMB analysis of the RHB-104 Phase III MAP US
study for Crohn's disease, top-line results from the BEKINDA(TM) Phase III
GUARD study for gastroenteritis and the initiation of a confirmatory Phase
III study with RHB-105 for the treatment of H. pylori infection. With a
strong cash position of approximately $53 million at the end of the first
quarter, we are well-positioned to execute our strategic and operational
plans for 2016."
Conference Call and Webcast Information:
The Company will host a conference call on Wednesday, April 20, 2016, at
9:00 am EST to review the financial results and business highlights.
To participate in the conference call, please dial the following numbers
five to ten minutes prior to the start of the call: United States:
+1-877-280-1254; International: +1-212-444-0481; and Israel:
+972-3-763-0147. The access code for the call is 8920444.
The conference call will be broadcasted simultaneously and available for
replay on the Company's website, http://ir.redhillbio.com/events.cfm, for
30 days. Please access the Company's website at least 15 minutes ahead of
the conference to register, download, and install any necessary audio
software.
Recent operational highlights:
1. On February 8, 2016, RedHill announced a research collaboration with
Leipzig-based Fraunhofer Institute for Cell Therapy and Immunology
(IZI), a research unit of the Fraunhofer Society, one of the largest
and most prominent applied research organizations in the world, for the
evaluation of RedHill's Phase II-stage oncology drug candidate, RP101.
The research collaboration tests RP101 in pre-clinical oncology models,
including pancreatic cancer, in combination with standard-of-care
chemotherapies to support existing Phase I and Phase II clinical data.
Results from the studies are expected during the second quarter of
2016.
2. On February 10, 2016, RedHill announced that it had received a Notice
of Allowance from the United States Patent and Trademark Office (USPTO)
for a new patent covering RHB-104. The patent, entitled "Compositions
Comprising Rifabutin, Clarithromycin, and Clofazamine and Uses Therof"
has since been issued and is valid through 2029. RedHill currently
holds five U.S. patents and multiple international patents for RHB-104.
3. On March 1, 2016, RedHill announced that it had completed enrollment of
over half of the planned 270 patients in the Phase III MAP US study for
Crohn's disease in the U.S. and additional countries. Interim DSMB
analysis of the study is expected in the second half of 2016.
4. On March 10, 2016, RedHill announced the publication of an article
evaluating the therapeutic potential of YELIVA(TM) (ABC294640), the
Company's orally-administered first-in-class Sphingosine kinase-2 (SK2)
selective inhibitor, for the treatment of cholangiocarcinoma (bile duct
cancer). The article, describing non-clinical studies conducted with
YELIVA(TM), was authored by scientists from the Mayo Clinic Cancer
Center, the Hollings Cancer Center at the Medical University of South
Carolina and Apogee Biotechnology Corporation. The authors concluded
that these findings provide preliminary insight into the possible use
of YELIVA(TM) as an anticancer drug for cholangiocarcinoma treatment,
as well as novel evidence that SK2 may be a rational therapeutic target
in the treatment of this cancer.
5. On March 29, 2016, RedHill and its co-development partner for RIZAPORT,
IntelGenx Corp., announced that they had entered into a binding term
sheet with Grupo JUSTE S.A.Q.F ("Grupo JUSTE") granting Grupo JUSTE the
exclusive license to commercialize RIZAPORT(TM) in Spain and a right of
first refusal for additional territories. Under the term sheet, subject
to remaining conditions, a definitive agreement is planned to be
entered into within 60 days of the execution of the term sheet. Under
the term sheet, RedHill and IntelGenx Corp. will receive an upfront
payment and will be eligible to receive additional milestone payments
upon achievement of certain predefined regulatory and commercial
targets, as well as tiered royalties. Commercial launch in Spain is
estimated to take place in the second half of 2017. RedHill also
reported that a new U.S. formulation patent covering RIZAPORT(TM) was
issued by the USPTO on April 5, 2016. The patent is valid until 2034.
6. On March 31, 2016, RedHill announced encouraging top-line interim
results from its ongoing CEASE-MS Phase IIa proof-of-concept (PoC)
clinical study evaluating fixed oral dose RHB-104 in patients treated
for relapsing-remitting multiple sclerosis (RRMS). The ongoing
CEASE-MS, single-arm, open-label study was designed with a series of
exploratory endpoints to evaluate the safety and potential efficacy of
fixed oral dose RHB-104 as an add-on therapy to interferon beta-1a in
18 patients treated for RRMS. Interim results after completion of the
24-week treatment period of the study demonstrated positive safety and
clinical signals and support further clinical development based on
encouraging preliminary data. Additional data reads are due at week 48
following a 24-week follow-up treatment period with interferon beta-1a,
without RHB-104 add-on. The top-line interim results demonstrated an
annualized relapse rate (ARR) at 24 weeks of 0.288 in the modified
intent-to-treat (mITT) population and 0.0 in the per-protocol (PP)
population, comparing favorably with previously reported pivotal
studies of interferon beta-1a therapies Avonex(R) (0.67) and Rebif(R)
(0.87-0.91) . 88% of the mITT patient population and 100% of the PP
patient population were relapse free at 24 weeks, comparing favorably
with previously reported pivotal data on the use of Rebif(R) (75%) in
comparison with Avonex(R) (63%) as standalone first line therapies ; No
patients in the CEASE-MS study relapsed after week 8 of treatment. With
only a single active T1 post gadolinium lesion noted among all patients
followed, combined unique active lesions (CUAs) - the primary outcome
measure in the study - were almost entirely MRI T2 lesions; Although
not powered for efficacy, a reduction in total MRI T2 lesion volume was
observed at 24 weeks as compared to baseline, suggesting a decreased
burden of disease and comparing favorably with previously reported
Avonex(R) and Rebif(R) data.
7. On April 11, 2016, RedHill announced that it had initiated a
randomized, double-blind, placebo-controlled, 2-arm parallel group
Phase II clinical study in the U.S. evaluating the safety and efficacy
of BEKINDA(TM) 12 mg in patients with diarrhea-predominant irritable
bowel syndrome (IBS-D). The study is expected to be conducted in 12
clinical sites in the U.S. and to enroll 120 patients who will be
randomized 60:40 to receive either BEKINDA(TM) 12 mg or a placebo, once
daily, for a period of eight weeks. The primary endpoint for the study
is the proportion of patients in each treatment group with response in
stool consistency as compared to baseline, per FDA guidance definition.
Secondary endpoints include the proportion of patients in each
treatment group who are pain responders and the proportion of patients
in each treatment group who are responders to the combined endpoints of
stool consistency and pain, per FDA guidance definition.
8. On April 18, 2016, RedHill announced that it had concluded a positive
Type B Meeting with the U.S. Food and Drug Administration (FDA)
regarding the path to marketing approval of RHB-105 and the planned
confirmatory Phase III study for the treatment of H. pylori infection.
The FDA confirmed, subject to final minutes of the meeting, the planned
two-arm, randomized, double-blind, active comparator design of the
confirmatory Phase III study with RHB-105 for the treatment of H.
pylori infection, expected to be initiated in the second half of 2016.
Based on FDA feedback, and subject to successful completion, the
planned confirmatory Phase III study, along with the successfully
completed first Phase III study and data from a supportive PK program,
are expected to support a U.S. New Drug Application (NDA) for RHB-105.
The announcement followed the successful final results from the first
Phase III clinical study with RHB-105 for the eradication of H. pylori
(the ERADICATE Hp study) reported on March 8, 2016. The Phase III
Clinical Study Report (CSR) confirmed the positive top-line results.
The study successfully met its primary endpoint of superiority over
historical standard-of-care (SoC) eradication rate levels of 70%, with
high statistical significance (p< 0.001). The final results emonstrated
89.4% efficacy in eradicating H. pylori infection with RHB-105. RHB-105
has been granted Qualifying Infectious Disease Product (QIDP)
designation by the FDA, providing a Fast-Track development pathway, as
well as Priority Review status, potentially leading to a shorter review
time by the FDA of a NDA, if filed. If approved, RHB-105 will also
receive an additional five years of U.S. market exclusivity, in
addition to the standard exclusivity period, for a total of 8 years of
market exclusivity.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is a biopharmaceutical company
headquartered in Israel, primarily focused on the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for the treatment of inflammatory and gastrointestinal
diseases, including cancer. RedHill's current pipeline of proprietary
products includes: (i) RHB-105 - an oral combination therapy for the
treatment of Helicobacter pylori infection with successful results from a
first Phase III study; (ii) RHB-104 - an oral combination therapy for the
treatment of Crohn's disease with an ongoing first Phase III study and an
ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii)
BEKINDA(TM) (RHB-102) - a once-daily oral pill formulation of ondansetron
with an ongoing Phase III study in the U.S. for acute gastroenteritis and
gastritis and a Phase II study for IBS-D; (iv) RHB-106 - an encapsulated
bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA(TM)
(ABC294640) - an orally-administered first-in-class SK2 selective inhibitor
targeting multiple oncology, inflammatory and gastrointestinal indications
with a Phase I/II study initiated for refractory/relapsed diffuse large
B-cell lymphoma (DLBCL); (vi) MESUPRON(R) - a Phase II-stage first-in-class
uPA inhibitor, administered by oral capsule, targeting gastrointestinal and
other solid tumors; (vii) RP101 - currently subject to an option-to-acquire
by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor,
administered by oral tablet, targeting pancreatic and other
gastrointestinal cancers; (viii) RIZAPORT(TM) (RHB-103) - an oral thin film
formulation of rizatriptan for acute migraines, with a U.S. NDA currently
under discussion with the FDA and marketing authorization received in
Germany in October 2015; and (ix) RHB-101 - a once-daily oral pill
formulation of the cardio drug carvedilol.
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; (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 establish
and maintain corporate collaborations; (vi) 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;
(vii) the interpretation of the properties and characteristics of the
Company's therapeutic candidates and of the results obtained with its
therapeutic candidates in research, preclinical studies or clinical trials;
(viii) the implementation of the Company's business model, strategic plans
for its business and therapeutic candidates; (ix) 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; (x)
parties from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; (xi) estimates of the Company's
expenses, future revenues capital requirements and the Company's needs for
additional financing; (xii) competitive companies and technologies within
the Company's industry; and (xiii) the impact of the political and security
situation in Israel on the Company's business. 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
Securities and Exchange Commission (SEC), including the Company's Annual
Report on Form 20-F filed with the SEC on February 25, 2016. All
forward-looking statements included in this Press Release are made only as
of the date of this Press Release. We assume no obligation to update any
written or oral forward-looking statement unless required by law.
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
<pre>
Three months ended March 31
2016 2015
U.S. dollars
in thousands
REVENUES - 1
RESEARCH AND DEVELOPMENT EXPENSES, net 4,676 3,829
GENERAL AND ADMINISTRATIVE EXPENSES 1,227 927
OPERATING LOSS 5,903 4,755
FINANCIAL INCOME 380 286
FINANCIAL EXPENSES 1 173
FINANCIAL INCOME, net 379 113
LOSS AND COMPREHENSIVE LOSS 5,524 4,642
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars) 0.04 0.05
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES (in thousands) 127,129 93,678
</pre>
The accompanying notes are an integral part of these financial statements.
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
<pre>
March 31 December 31
2016 2015
U.S. dollars
in thousands
CURRENT ASSETS:
Cash and cash equivalents 12,026 21,516
Bank deposits 34,674 36,622
Financial assets at fair value through profit or loss 6,580 -
Prepaid expenses and receivables 1,932 2,372
55,212 60,510
NON-CURRENT ASSETS:
Bank deposits 140 134
Fixed assets 143 124
Intangible assets 6,060 6,060
6,343 6,318
TOTAL ASSETS 61,555 66,828
CURRENT LIABILITIES:
Accounts payable and accrued expenses 3,582 3,514
Payable in respect of intangible asset purchase 2,000 2,000
5,582 5,514
NON-CURRENT LIABILITIES:
Derivative financial instruments 1,036 1,237
TOTAL LIABILITIES 6,618 6,751
EQUITY:
Ordinary shares 343 343
Additional paid-in capital 120,631 120,621
Warrants 1,057 1,057
Accumulated deficit (67,094) (61,944)
TOTAL EQUITY 54,937 60,077
TOTAL LIABILITIES AND EQUITY 61,555 66,828
</pre>
The accompanying notes are an integral part of these financial statements.
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
<pre>
Three months
ended March 31
2016 2015
U.S. dollars
in thousands
CASH FLOWS FROM OPERATING ACTIVITIES:
Comprehensive loss (5,524) (4,642)
Adjustments in respect of income and expenses not
involving cash flow:
Share-based compensation to employees and service
providers 374 322
Depreciation 10 9
Unrealized gain on derivative financial instruments (201) (248)
Fair value gains on financial assets at fair value
through profit or loss (8)
Revaluation of bank deposits (58) (4)
Exchange differences in respect of cash and cash
equivalents (82) 167
Changes in assets and liability items:
Decrease in prepaid expenses and receivables 440 706
Increase in accounts payable and accrued expenses 68 318
543 1,270
Net cash used in operating activities (4,981) (3,372)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of fixed assets (29) (2)
Purchase of intangible assets - (75)
Purchase of financial assets at fair value through
profit or loss (6,572) -
Change in investment in current bank deposits 2,000 (7,000)
Net cash used in investing activities (4,601) (7,077)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of ordinary shares, net of
expenses - 13,198
Exercise of options into ordinary shares 10 -
Net cash provided by financing activities 10 13,198
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (9,572) 2,749
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS 82 (167)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD 21,516 5,892
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD 12,026 8,474
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH 94 26
SUPPLEMENTARY INFORMATION ON INVESTING ACTIVITIES NOT
INVOLVING CASH FLOWS:
Purchase of intangible assets - 3,425
</pre>
The accompanying notes are an integral part of these financial statements.
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459687 02.05.2016
DGAP-News: RedHill Biopharma Ltd.: RedHill Biopharma Reports 2016 First Quarter Financial Results
| Source: EQS Group AG