RDHL (MC $150M) $60+M Cash 3 BIG Drugs with P3 data in 1H17

Thanks Jham! I bought a little. I'll probably buy some more tomorrow or Fri.

*REMINDER*

Today is the "BEKINDA DAY"


RedHill Biopharma to Host R&D Day on BEKINDA for Acute Gastroenteritis and IBS-D


The R&D Day on BEKINDA® will take place on Thursday, April 27, 2017 in NYC from 8:00-10:00 EDT; A live webcast will be available through RedHill’s website

Top-line results from a Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis are expected in Q2/2017

Top-line results from a Phase II study with BEKINDA® 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) are expected in Q3/2017


You can access the call from this page:


ir.redhillbio.com/events.cfm

Yep. Lots of good stuff from this presentation. Q&A is still ongoing, but here are a few things that stood out.

- GUARD trial investigator said they were pleasantly surprised at how many patients didn't need a second dose because their vomiting stopped after the first dose

- The market sizes for both indications (Gastroenteritis and IBS) for BEKINDA are separate and bigger than I thought (currently $1B and $1.8B respectively) and growing. In the billions for each (see slides)

- CEO said that they are in talks with several "parties" about licensing all of their programs (not only BEKINDA) outside the US. RedHill plans to go it alone in the US

- CEO said that they plan on having licensing partnerships done by the end of this year*


*I am not sure if he was referring to the two BEKINDA programs or all of their P3 programs. Need to listen again.

Here are the KOLs that spoke:


Robert A. Silverman, MD, MS
Lead Investigator, BEKINDA® Phase III Study
Emergency Medicine specialist at the Hofstra North Shore-LIJ Medical Center, Associate Professor at the Hofstra North Shore-LIJ School of Medicine in NY

M. Scott Harris, MD, MS, FACP, AGAF
Consultant to RedHill Biopharma
Member of the Executive Board of the Center for Diagnostics and Therapeutics of the American Gastroenterological Association, Professor of Clinical Pharmacology and Physiology at Georgetown University School, Principal, Middleburg Consultants

Jerry Rosenblatt, PhD
RedHill Biopharma Advisory Board
Managing Partner, Foster Rosenblatt

This is the slide that mentions the "major opportunity" for BEKINDA, that I was talking about..

OK, now I have a much better understanding about BEKINDA, and more reason to think the trial will be successful. 

Ondansetron is the number one prescribed drug in emergency departments and is the drug of choice to treat acute gastroenteritis. There have been 9 studies on the drug that have proven it significantly lowers incidence of vomiting in gastritis/IBS sufferers. It is already approved and on the market for other indications, but not for GI (gastro intestinal) indications. So, RedHill simply took Ondansetron, reformulated it, patented it, and is now trying to be the first to launch it onto the GI market. So basically, they know it is safe and they know it works (already the number one prescribed drug for GI diseases). I guess the biggest risk here is if anything changed in the re-formulation. I need to read up more about that, but I imagine they kept it virtually the same. 

The below is from the RedHill website:

 
BEKINDA® (formerly RHB-102) is a proprietary, oral, extended-release (24 hours), once-daily pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications.

Ondansetron is a 5-HT3 (serotonin) receptor antagonist which is marketed under various trade names including GSK’s Zofran®. 5-HT3 receptor antagonists are considered the most effective and significant class of drugs in prevention of nausea and vomiting.

BEKINDA® is currently the only once-daily oral formulation of ondansetron, and is likely to be the first to reach the U.S. and European market.

BEKINDA® was licensed from SCOLR Pharma, Inc. [Amex: DDD] in May 2010. RedHill secured the direct rights to the original patents from Temple University, following SCOLR’s announcement that the they had ceased their business operations.

The good news is no debt and $61M in cash. Also BEKINDA GUARD P3 study data still on schedule for release this quarter. Bad news is it looks like the interim data for P3 MAP study for Crohn's disease has been pushed back to "Mid-year", instead of Q2. Not a big deal, but I wouldn't be surprised to see a dip today because of it. Earnings call today at 9am.


www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1365&PID=0&IID=5115

RedHill Biopharma Reports 2017 First Quarter Financial Results
3 May, 2017
* RedHill maintains a debt-free balance sheet with a $61 million cash balance1 at the end of the first quarter of 2017, allowing the Company to continue to diligently execute its development and U.S. commercialization plans
 
Select recent milestones include:
* Exclusive U.S. co-promotion agreement for commercial GI drug Donnatal®2


* Exclusive license agreement for commercial GI product EnteraGam®3


* Completion of patient enrollment and treatment in the Phase III GUARD study with BEKINDA® (RHB-102) 24 mg for acute gastroenteritis and gastritis


* Completion of patient enrollment in the Phase II study with BEKINDA® 12 mg for IBS-D


* Initiation of an open-label extension study to the Phase III MAP US study with RHB-104 for Crohn’s disease


* FDA QIDP Fast-Track designation granted to RHB-104 for nontuberculous mycobacteria (NTM) infections


* Orphan Drug designation granted to YELIVA® (ABC294640) for the treatment of cholangiocarcinoma
 
Select potential milestones expected in the coming months:   
* Top-line results from the BEKINDA® 24 mg Phase III GUARD study for gastroenteritis and gastritis (the GUARD study) expected in Q2/2017


* Top-line results from the BEKINDA® 12 mg Phase II study for IBS-D expected in Q3/2017


* Initiation of the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection expected in Q2/2017


* Second independent DSMB meeting for the MAP US Phase III study with RHB-104 for Crohn’s disease, including an interim efficacy analysis and evaluation of an option for early stop for success for overwhelming efficacy, expected mid-year


* Initiation of U.S. promotional activities for Donnatal® and EnteraGam® expected in Q2/2017


* Initiation of additional Phase I/II studies with YELIVA® for cholangiocarcinoma, prevention of mucositis in head and neck cancer and ulcerative colitis expected in H2/2017


* Initiation of a Phase I/II study with MESUPRON in pancreatic cancer expected in H2/2017
 
TEL-AVIV, Israel, May 3, 2017 RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the 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 March 31, 2017.
The Company will host a conference call on Wednesday, May 3, 2017, at 9:00 am EDT to review the financial results and business highlights. Dial-in details are included below. 
Financial highlights for the quarter ended March 31, 20174
Research and Development Expenses for the first quarter of 2017 were $8.1 million, up 74% compared to the first quarter of 2016 and up 9% compared to the fourth quarter of 2016. The increase was mainly due to the ongoing Phase III and Phase II studies with BEKINDA® (RHB-102)5 for gastroenteritis and diarrhea-predominant irritable bowel syndrome (IBS-D), respectively, the ongoing Phase III study with RHB-104 for Crohn’s disease, ongoing studies with YELIVA® (ABC294640)6 for multiple indications and preparations for the upcoming confirmatory Phase III study with RHB-105 for H. pyloriinfection.
Selling, Marketing and Business Development Expenses for the first quarter of 2017 were $0.6 million, up 94% compared to the first quarter of 2016. The increase was mainly due to activities related to the Company’s U.S. commercial operations.
General and Administrative Expenses for the first quarter of 2017 were $1.3 million, up 44% compared to the first quarter of 2016 and up 12% compared to the fourth quarter of 2016. The increase was mainly due to expanded operations.
Operating Loss for the first quarter of 2017 was $10.1 million, up 71% compared to the first quarter of 2016 and up 12% compared to the fourth quarter of 2016. The increase was mainly due to an increase in Research and Development Expenses, as detailed above.
Financial Income, net for the first quarter of 2017 was $1.5 million, compared to $379 thousand in the first quarter of 2016. The increase was mainly due to a fair value gain on derivative financial instruments related to investors’ warrants from the December 2016 financing.
Net Cash Used in Operating Activities for the first quarter of 2017 was $10.3 million, up 107% compared to the first quarter of 2016 and up 1% compared to the fourth quarter of 2016. The increase was mainly due to the increase in Operating Loss, as detailed above.
Net Cash Used in Investment Activities for the first quarter of 2017 was $18.6 million, compared to $4.6 million in the first quarter of 2016. The increase was mainly due to investments of the cash in bank deposits and purchase of marketable securities.
Net Cash Provided by Financing Activities for the first quarter of 2017 was $4.5 million compared to an immaterial amount for the first quarter of 2016. The increase was mainly due to proceeds from the exercise of warrants and options into ordinary shares.
Cash Balance as of March 31, 2017 was $61 million, a decrease of $5 million, compared to $66 million as of December 31, 2016. The decrease was a result of cash used in operating activities and investment activities, offset by cash provided by financing activities, as described above.
Micha Ben Chorin, RedHill’s CFO, said: “We are pleased with the achievements in the first quarter of 2017, which included securing rights for two commercial GI products in the U.S. as part of RedHill’s strategic plan of becoming a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the U.S. and setting the stage for our late clinical-stage pipeline drugs, if approved. Our cash position of $61 million at the end of the first quarter should allow us to continue to execute our strategic plans for 2017 and diligently advance our late-stage clinical programs. We look forward to important events expected in the coming months, including top-line results from the Phase III GUARD study with BEKINDA®for gastroenteritis, initiation of the confirmatory Phase III study with RHB-105 for H. pylori infection, a second independent DSMB meeting for the ongoing Phase III MAP US study with RHB-104 for Crohn’s disease and the initiation of promotional activities in the U.S. with Donnatal® and EnteraGam®.”
Conference Call and Webcast Information:
The Company will host a conference call on Wednesday, May 3, 2017, at 9:00 am EDT to review the financial results and business highlights.
To participate in the conference call, please dial the following numbers 15 minutes prior to the start of the call: United States: +1-877-280-2342; International: +1-212-444-0896; and Israel: +972-3-763-0147. The access code for the call is 1922788.
The conference call will be broadcasted live and available for replay on the Company's website, 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 January 3, 2017, RedHill announced the signing of an exclusive co-promotion agreement with a subsidiary7 of Concordia International Corp. (NASDAQ: CXRX) (TSX: CXR) (“Concordia”), granting RedHill certain U.S. promotion rights for Donnatal®8, a prescription oral drug used with other drugs for the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel). Under the terms of the agreement, RedHill and Concordia will share the revenues generated from the promotion of Donnatal® by RedHill, based on an agreed upon split.


2. On January 5, 2017, RedHill announced the signing of a new collaboration agreement with the Department of Molecular Biology and Genetics of Denmark-based Aarhus University for the evaluation of RedHill’s Phase II-stage oncology drug candidate, MESUPRON (upamostat). The new research collaboration follows previous non-clinical studies conducted with Denmark’s Aarhus University and is designed to identify additional high affinity molecular targets of MESUPRON. A Phase I/II study with MESUPRON in pancreatic cancer is planned to be initiated in the second half of 2017.


3. On January 10, 2017, RedHill announced first dosing in a three-way crossover pharmacokinetic (PK) study with RHB-105 in 18 subjects (healthy volunteers), intended to evaluate the bioavailability of RHB-105 actives versus the comparator in the planned confirmatory Phase III study (dual therapy of amoxicillin and omeprazole) and a food-effect study with RHB-105. The confirmatory Phase III study with RHB-105 for pylori infection is planned to be initiated in the second quarter of 2017. Subject to a successful outcome, the confirmatory Phase III study and the supportive PK program are expected to complete the package required for a U.S. NDA for RHB-105.


4. On January 11, 2017, RedHill announced that RHB-104 had been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for the treatment of nontuberculous mycobacteria (NTM) infections. The QIDP designation was granted under the FDA's Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. Under the FDA's GAIN Act, QIDP designation allows for Fast-Track status and Priority Review, potentially leading to a shorter NDA review time by the FDA, and, if approved, an additional five years of U.S. market exclusivity on top of the standard exclusivity period. RedHill plans to consult with the FDA regarding the RHB-104 development program for NTM infections.


5. On February 21, 2017, RedHill announced that the last patient enrolled in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA®24 mg in the U.S. for the treatment of acute gastroenteritis and gastritis (the GUARD study) had completed the treatment course and observation period for the primary endpoint evaluation. The GUARD study treated 321 adults and children over the age of 12 in 29 U.S. clinical sites. Top-line results are expected in the second quarter of 2017. Furthermore, on April 18, 2017, RedHill announced that it had received notices of allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA®. Once granted, the patents are expected to be valid until at least 2034.
 
6. On March 21, 2017, RedHill announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn’s disease (the MAP US study). The open-label extension study (the MAP US2 study) is intended to assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the ongoing MAP US study and remain with active Crohn’s disease (CDAI>150); these patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label extension study.
 
7. On April 4, 2017, RedHill announced that the FDA had granted YELIVA® (ABC294640) Orphan Drug designation for the treatment of cholangiocarcinoma. Orphan Drug designation allows RedHill to benefit from a seven-year marketing exclusivity period for the indication, if approved for marketing, as well as other development incentives to develop YELIVA® for cholangiocarcinoma. A Phase IIa clinical study with YELIVA® in patients with advanced, unresectable, intrahepatic and extrahepatic cholangiocarcinoma is planned to be initiated in the third quarter of 2017. 


8. On April 5, 2017, RedHill announced the signing of an exclusive license agreement with Entera Health Inc. (“Entera Health”), granting RedHill the exclusive U.S. rights to EnteraGam®9, a commercially-available medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. Under the terms of the agreement, RedHill will pay Entera Health royalties based on net sales generated from the sale of EnteraGam® by RedHill.

9. On April 13, 2017, RedHill, together with IntelGenx Corp. (TSXV: IGX; OTCQX: IGXT) (“IntelGenx”), announced that the Ministry of Health of Luxembourg had granted national marketing authorization for RIZAPORT® (5 mg and 10 mg). The national marketing authorization was granted in Luxembourg on the basis of the European Decentralized Procedure (DCP), in which Luxembourg served as the Concerned Member State. The approval in Luxembourg marks the completion of the current marketing approval process for RIZAPORT® under the European DCP.


10. On April, 24, 2017, RedHill announced enrollment of the last patient in the Phase II study with BEKINDA® 12 mg for the treatment of IBS-D. The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA® 12 mg in 127 U.S. patients with IBS-D. Top-line results are expected in the third quarter of 2017.
 

Nothing too special on the call. It looks like the order of milestones are BEKINDA GUARD study data, BEKINDA IBS-D study data, commencement of P3 confirmatory trial for H. Pylori, MAP P3 study for CD data, launching of Donnatal/EnteraGam promotion.

Most questions in the Q&A were about Donnatal/EnteraGam. Even though Donnatal's sales have been declining, they think there is still money to be made there. They couldn't give any revenue projections, but think it will be worth it. They will have 30 sales reps and are basically all ready to go.

There was more, but that is all that stood out to me.

Thank you JHam:

About the sales reps for Donnatal ann EnteraGam, my feeling is that the real focus is not perhaps those products. It will be an added bonus if they make some money but I am not expecting any reasonable money from these. The strategy seem to be get the reps on field well ahead of the other product launches and build relationships with the doctors. That will give them a head start when the real gems which are their own products are launched. This company seem to be making all moves right.