RedHill Biopharma Reports 2017 Third Quarter Financial Results
RedHillmaintains a debt-free balance sheet with $39.6 millionin cash1 at the end of the third quarter of 2017
- In addition, an underwritten public offering of the Company's American Depositary Shares (ADSs) is scheduled to be closed today,
November 13, 2017, subject to customary terms and conditions, for aggregate net proceeds of approximately $20.6 million, after deducting underwriting discounts and commissions and other offering expenses
- Net revenues of approximately
$1.5 millionin Q3/2017 from the promotion of three GI-specialty products in the U.S., Donnatal®, EnteraGam® (launched in June) and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg (launched mid-September)
- Decrease quarterly cash burn rate and continued revenue growth are expected in 2018
- Increased focus on partnerships and
U.S.co-promotion of select RedHilldevelopment programs
Select recent and potential milestones:
- Top-line results from the first Phase III study with RHB-104 for Crohn's disease (MAP US study) expected in mid-2018; patient enrollment completed
- Top-line results from the confirmatory Phase III study with TALICIA™ (RHB-105) (ERADICATE HP2 study) for the treatment of H. pylori infection, expected in H2/2018
- Initiation of pivotal Phase III study with RHB-104 for first line treatment of Nontuberculous Mycobacteria (NTM) infections expected in H1/2018
- Successful top-line results from the Phase II study with BEKINDA® (RHB-102) 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D)
The Company will host a conference call today,
Financial highlights for the quarter ended
Net Revenues for the third quarter of 2017 were approximately
Cost of Revenues for the third quarter of 2017 was
Gross Profit for the third quarter of 2017 was
Research and Development Expenses for the third quarter of 2017 were
General and Administrative Expenses for the third quarter of 2017 were
Selling, Marketing and Business Development Expenses for the third quarter of 2017 were
Operating Loss for the third quarter of 2017 was
Financial Expenses, net for the third quarter of 2017 was
Net Cash Provided by Investing Activities for the third quarter of 2017 was
Cash Balance7 as of
"The third quarter of 2017 was the first full quarter of revenues generation from the promotion of Donnatal® and EnteraGam®, with
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
+972-3-763-0147. The access code for the call is: 2543708.
The conference call will be broadcasted live and will be 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 call to register, download and install any necessary audio software.
Recent operational highlights:
July 31, 2017, RedHillreported, following a second pre-planned meeting by an independent Data and Safety Monitoring Board (DSMB) to assess the safety and efficacy data from its ongoing first Phase III study with RHB-104 for Crohn's disease (the MAP US study), that it had received a unanimous recommendation from the DSMB to continue the study as planned. The DSMB reviewed safety and efficacy data, of which RedHillremains blinded, from the first 222 subjects who had completed week 26 assessments in the Phase III MAP US study.
September 13, 2017, RedHillannounced that it had initiated promotion of Esomeprazole Strontium DR Capsules 49.3 mg in the U.S.Esomeprazole Strontium DR Capsules 49.3 mg is a U.S. Food and Drug Administration(FDA)-approved, proprietary, prescription proton pump inhibitor (PPI) indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions9. On August 17, 2017, RedHillannounced that it had entered into a commercialization agreement with ParaPRO LLC, an Indiana-based specialty pharmaceutical company, granting RedHillthe exclusive rights to promote Esomeprazole Strontium DR Capsules 49.3 mg to gastroenterologists in certain U.S.territories.
September 18, 2017, RedHillannounced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the use of two of RedHill's Phase II-stage proprietary investigational compounds, YELIVA® and MESUPRON (upamostat)10 in combination with a known antibiotic. Upon issuance, on top of existing intellectual property (IP) protection covering the individual compounds, the new patent will provide RedHillwith IP protection covering its combination for the potential treatment of cancer, prevention of cancer recurrence or progression and inhibition of growth and proliferation of cancer cells.
October 3, 2017, RedHillannounced positive top-line results from the Phase II study with BEKINDA® 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). The study successfully met its primary endpoint, improving primary efficacy outcome of stool consistency. RedHill plans one or more pivotal Phase III studies with BEKINDA® 12 mg in IBS-D. RedHillfurther announced that, following the positive results from its Phase III GUARD study with BEKINDA® 24 mg in acute gastroenteritis and gastritis, the Company met with the FDAto discuss the results and the clinical and regulatory path towards potential marketing approval of BEKINDA® 24 mg in the U.S.Following the positive FDAguidance meeting, the Company is currently working with the FDAto design the confirmatory Phase III study to support a New Drug Application (NDA) with BEKINDA® 24 mg for acute gastroenteritis and gastritis.
October 20, 2017, RedHillannounced that the FDAgranted MESUPRON (upamostat) Orphan Drug designation for the adjuvant treatment of pancreatic cancer. The Orphan Drug designation allows RedHillto benefit from various incentives to develop MESUPRON for this indication, including a seven-year marketing exclusivity period for the indication, if approved. Following the recent identification of a new mechanism of action for MESUPRON, inhibition of trypsin, RedHillis currently evaluating potential utilization of MESUPRON in several GI indications.
October 23, 2017, RedHillannounced that it had received a Notice of Allowance from the USPTO for a new patent covering RHB-104 for relapsing-remitting multiple sclerosis (MS), which is expected to be valid until 2032, once granted.
November 1, 2017, RedHillannounced, together with IntelGenx Corp.("IntelGenx"), that they had resubmitted the 505(b)(2) New Drug Application (NDA) for RIZAPORT® 10 mg to the FDA. If the RIZAPORT® NDA resubmission is deemed complete and permits a full review by the FDA, a Prescription Drug User Fee Act (PDUFA) date is expected to be set by the FDAfor the first half of 2018.
November 9, 2017, RedHillannounced that the last patient had been enrolled in the Phase III study with RHB-104 for Crohn's disease (MAP US study). The study enrolled 331 subjects across approximately 150 clinical sites in the U.S., Canada, Europe, Israel, Australia and New Zealand. Top-line results are expected to be announced in mid-2018. On October 2, 2017, RedHillannounced that it had curtailed the target sample size in the Phase III study with RHB-104 for Crohn's disease (MAP US study) from 410 to approximately 325 subjects, while maintaining statistical power of over 80% with a treatment effect of 15%.
About Esomeprazole Strontium Delayed-Release Capsules 49.3 mg12:
Esomeprazole Strontium Delayed-Release Capsules 49.3 mg is indicated for adults:
- for the short-term treatment (4-8 weeks) of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) and/or in healing and symptomatic resolution of erosive esophagitis (EE).
- to reduce the risk of stomach ulcers in some people taking non-steroidal anti-inflammatory drugs (NSAIDs) (controlled studies did not extend beyond 6 months).
- in combination with amoxicillin 1000 mg and clarithromycin 500 mg is indicated for the treatment of patients with a stomach infection (Helicobacter pylori) and duodenal ulcer disease.
- is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
Important Safety Information about Esomeprazole Strontium Delayed-Release Capsules 49.3 mg:
- Esomeprazole strontium is contraindicated in patients with known hypersensitivity to proton pump inhibitors. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole strontium, refer to the contraindications section of their package inserts.
- Symptomatic response to therapy does not rule out the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy.
- Acute interstitial nephritis has been observed in patients taking PPIs. Discontinue esomeprazole strontium if acute interstitial nephritis develop.
- PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. This diagnosis should be considered for diarrhea that does not improve.
- PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose (multiple daily doses) and long-term (a year or longer) therapy.
- Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole. These events included both new onset and exacerbations. If signs or symptoms consistent with CLE or SLE are noted with esomeprazole strontium, discontinue and refer the patient to a specialist. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.
- Avoid concomitant use of esomeprazole strontium with clopidogrel, due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using esomeprazole strontium consider alternative anti-platelet therapy.
- Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12). Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature.
- Hypomagnesemia has been reported rarely with prolonged treatment with PPI therapy and may require discontinuing PPI therapy.
- Concomitant use of esomeprazole strontium and St. John's wort or rifampin can substantially decrease esomeprazole strontium concentrations. Avoid concomitant use.
- Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
- Concomitant use of esomeprazole strontium and atazanavir or nelfinavir is not recommended. esomeprazole strontium is expected to increase the plasma levels of saquinavir. Consider dose reduction of saquinavir.
- Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, erlotinib, digoxin and mycophenolate mofetil).
- Esomeprazole strontium may increase systemic exposure of cilastozol and one of its active metabolites. Consider dose reduction of cilastozol.
- In adults, adverse reactions (ARs) reported at a frequency of 1% or greater with esomeprazole strontium include headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.
- Safety and effectiveness of esomeprazole strontium have not been established in pediatric patients. Not recommended for use in pediatric patients.
- Safety of esomeprazole strontium has not been studied in patients with severe renal impairment. Not recommended for use in patients with severe renal impairment.
Talk to your doctor or healthcare professional. Please see Prescribing information including Medication Guide for Esomeprazole Strontium Delayed-Release Capsules at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-
Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines. Donnatal® comes in two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a fast-acting liquid.
Important Safety Information about Donnatal®:
Donnatal® is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breastfeeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.
Further information, including prescribing information, can be found on www.donnatal.com.
Please see the following website for complete important safety information about Donnatal®:
To report suspected adverse reactions, contact
1-877-370-1142 or email: email@example.com, or the
EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision. EnteraGam® binds microbial components13, such as toxic substances released by bacteria, that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine, which may contribute to chronic diarrhea and loose stools in people who have specific intestinal disorders14.
Safety Information about EnteraGam®:
EnteraGam® contains beef protein; therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.
EnteraGam® does not contain any milk-derived ingredients such as lactose, casein or whey. EnteraGam® is gluten-free, dye-free and soy-free.
Please see full Product Information.
To report suspected adverse reactions, contact
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 successfully market Donnatal® and
EnteraGam®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
|IR contact (|
Senior Vice President
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|Three months ended||Nine months ended|
|U.S. dollars in thousands|
|COST OF REVENUES||935||—||1,207||—|
|RESEARCH AND DEVELOPMENT EXPENSES, net||8,106||7,038||24,677||17,745|
|SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES||4,189||*402||8,170||1,138|
|GENERAL AND ADMINISTRATIVE EXPENSES||2,258||*1,014||5,513||2,669|
|FINANCIAL EXPENSES (INCOME), net||1,547||490||(2,475||)||(531||)|
|LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD||15,512||8,944||35,131||21,020|
|LOSS PER ORDINARY SHARE, BASIC AND DILUTED (||0.09||0.07||0.21||0.17|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
|U.S. dollars in thousands|
|Cash and cash equivalents||18,663||53,786|
|Financial assets at fair value through profit or loss||12,645||12,313|
|Trade receivables and contract assets||1,399||*99|
|Prepaid expenses and other receivables||2,760||*1,562|
|Accrued expenses and other current liabilities||9,149||*3,296|
|Payable in respect of intangible asset purchase||1,000||2,000|
|Derivative financial instruments||4,307||6,155|
|Additional paid-in capital||156,616||150,838|
|TOTAL LIABILITIES AND EQUITY||50,299||74,212|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
|Three months ended||Nine 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||640||449||1,652||1,318|
|Write-off of intangible asset||—||—||45||—|
|Unrealized losses (gains) on derivative financial instruments||1,685||585||(1,828||)||(130||)|
|Fair value losses (gains) on financial assets at fair value through profit or loss||(12||)||(10||)||67||(72||)|
|Revaluation of bank deposits||(3||)||(108||)||(108||)||(255||)|
|Exchange differences in respect of cash and cash equivalents||46||(36||)||(315||)||(77||)|
|Changes in assets and liability items:|
|Increase in trade receivables and contract assets||(621||)||—||(1,300||)||—|
|Decrease (increase) in prepaid expenses and other receivables||336||150||(1,198||)||342|
|Decrease (increase) in inventory||389||—||(221||)||—|
|Increase (decrease) in accounts payable||737||*(417)||1,822||*(94)|
|Increase in accrued expenses||1,734||*950||5,853||*1,868|
|Net cash used in operating activities||(10,555||)||(7,370||)||(30,604||)||(18,088||)|
|Purchase of fixed assets||(41||)||(10||)||(143||)||(55||)|
|Purchase of intangible assets||(1,035||)||—||(1,035||)||—|
|Change in investment in current bank deposits||7,284||14,668||(7,976||)||14,668|
|Purchase of financial assets at fair value through profit or loss||(978||)||(3,976||)||(14,931||)||(11,456||)|
|Proceeds from sale of financial assets at fair value through profit or loss||8,685||—||14,532||—|
|Net cash provided by (used in) investing activities||13,915||10,682||(9,553||)||3,157|
|Proceeds from issuance of ordinary shares, net of expenses||—||—||1,282||—|
|Exercise of warrants and options into ordinary shares, net of expenses||30||—||3,437||110|
|Net cash provided by financing activities||30||—||4,719||110|
|DECREASE (INCREASE) IN CASH AND CASH EQUIVALENTS||3,390||3,312||(35,438||)||(14,821||)|
|EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS||(46||)||36||315||77|
|BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD||15,319||3,424||53,786||21,516|
|BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD||18,663||6,772||18,663||6,772|
|SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH||153||133||354||185|
1 Including cash, short-term investments and non-current bank deposits.
2 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
3 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.
4 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.
5 Esomeprazole Strontium Delayed-Release (DR) Capsules 49.3 mg is an
6 Esomeprazole Strontium Delayed-Release (DR) Capsules 49.3 mg is an
7 TALICIA™, BEKINDA® and YELIVA® are investigational new drugs, not available for commercial distribution.
8 Including cash and short-term investments and non-current bank deposits.
9 For more information, please see the prescribing information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display.
10 MESUPRON is an investigational new drug, not available for commercial distribution.
11 Xifaxan® (rifaximin) prescribing information: www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf; Viberzi® (eluxadoline) prescribing information: www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf; Average absolute difference from reported Phase III studies; The theoretical comparison between the BEKINDA® Phase II study results and reported data from studies of IBS-D-approved therapies serves as a general benchmark for the effect size observed with BEKINDA® and should not be construed as a direct and/or equal comparison given that the studies were not identical in design, patient population and treatment period. For example, in the Xifaxan® Phase III studies, the referenced efficacy endpoints were evaluated over a period of 4 weeks after 2 weeks of drug administration, and in the Viberzi® Phase III studies, the referenced efficacy endpoints were evaluated after the drug was administered and evaluated for 12 weeks. The studies were not conducted head-to head in the same patient population.
12 Esomeprazole Strontium Delayed-Release Capsules is also available in a 24.65 mg dose.
13 Horgan A, Maas K, Henderson A, Detzel C, Weaver E. Serum-derived bovine immunoglobulin/protein isolate binds to pathogen-associated molecular patterns. Poster presented at:
14 Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-190. Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G. New insights into the pathophysiology of IBS: intestinal microflora, gas production and gut motility. Eur Rev Med Pharmacol Sci. 2008;12 Suppl 1:111-117.Source:
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