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RedHill Biopharma

Co-promotion deal and key catalysts in 2017

Update | Pharmaceuticals & healthcare | 12 Jan 2017

On 27 December the company completed a successful $38m fund-raising and announced a co-promotion deal in the US, which may turn RedHill into a commercial-stage, revenue-generating gastrointestinal specialty pharma company. In addition, the company revealed final results from the Phase IIa trial for RHB-104 in multiple sclerosis, which echoed positive interim findings earlier in 2016. Next steps will depend on further detailed analysis. Our post fund-raise valuation is NIS1.5bn ($378m) ahead of several key late-stage catalysts in 2017.

RedHill Biopharma

GI-focused pharma with multiple catalysts ahead

Initiation | Pharmaceuticals & healthcare | 24 Nov 2016

RedHill Biopharma is a biopharmaceutical company with a diversified, balanced R&D pipeline and late-stage assets focusing on gastrointestinal (GI) diseases and inflammation. The three most advanced Phase III-stage products have been significantly de-risked, target areas with high unmet need and may deliver four key readouts with the next 18 months. We initiate coverage of RedHill with a valuation of NIS1.21-1.29bn or NIS9.5-10.1/share.

RedHill Biopharma

TALICIA Ph III top-line data positive

Update | Pharmaceuticals & healthcare | 19 Dec 2018

On 3 December, RedHill announced positive top-line data for its second Phase III study for TALICIA in first-line Helicobacter pylori infection. With the focus now on final data, expected NDA submission (H119), approval and launch (potentially H219), TALICIA is one of the key value drivers for RedHill in the short term. The December share issue of $20m should ensure a smooth TALICIA launch, provide working capital for a pivotal Phase III nontuberculous mycobacteria trial, preparation for a Phase III trial in Crohn’s disease and support the commercial US organisation. Our updated valuation is $491m (NIS1.82bn), or $17.3/ADS (NIS6.4/sh).

RedHill Biopharma

Ph III with TALICIA data readout end-2018

Update | Pharmaceuticals & healthcare | 02 Oct 2018

In the past few weeks, RedHill has reached several R&D milestones: completion of enrolment for the Phase III TALICIA study for H. pylori infection (data end-2018), advancement to the second stage of the Phase IIa YELIVA study for cholangiocarcinoma, and a positive FDA meeting to discuss BEKINDA for IBS-D (now Phase III-ready). In addition, on 14 August RedHill announced a successful equity raise of $25m gross ($23.5m net), which will be used to fund the company’s ongoing R&D programmes. Our valuation is slightly higher at $432m (NIS1.5bn) but lower on a per share basis $16.9/ADS (NIS6.1/share) after the share issue.

RedHill Biopharma

RHB-104 data look good

Update | Pharmaceuticals & healthcare | 08 Aug 2018

RedHill reported top-line results from its Phase III trial with RHB-104 in Crohn’s Disease (CD). The primary endpoint was met with 37% of patients in the active arm achieving remission at week 26 compared to 23% in placebo (p=0.013). Several other key secondary endpoints also demonstrated efficacy but, judging from the share price volatility on the day of the announcement and various comments in the public space, a lot of attention was paid to the secondary endpoint dealing with isolated late induction of remission at week 52, which introduced confusion, in our view. The initial share price reaction was positive with a >60% gain, but retracted, closing down 7.2%. We note that RedHill’s share price is up by more than 40% versus the current price since May 2018 and given that the RHB-104 data readout was the single biggest catalyst in mid-2018, we believe the share price appreciation over the last few months reflects the value added by RHB-104. Our new valuation is $423m or $19.8/ADS.

RedHill Biopharma

Continued GI product growth, CD PhIII data in 3M

Update | Pharmaceuticals & healthcare | 24 May 2018

With its Q118 results, RedHill reported GI product revenues growing by 22% q-o-q to $2.4m in Q118. It also provided updates on its Phase III programmes. The last patient has been assessed against the primary endpoint in the RHB-104 first Phase III trial in Crohn's disease (CD), and top-line data are expected by August (including) this year. Additionally, more than 70% of patients have been enrolled for the TALICIA confirmatory Phase III trial in H. pylori infection. Management now expects top-line data from this trial in Q418. We value the company at $404.5m (NIS1.5bn) or $19.0/ADS (NIS6.8/share).

RedHill Biopharma

Commercial stage, GI-focused R&D pharma

Outlook | Pharmaceuticals & healthcare | 29 Mar 2018

2017 saw RedHill transformed from a pure drug developer into a commercial-stage, revenue-generating, specialty pharma company focused on gastrointestinal (GI) indications. During 2017, it began marketing three GI products in the US and we expect a rapid sales build-up. Two other important share price catalysts in 2018 will be the data readouts from two Phase III trials – RHB-104 for Crohn’s disease (CD) and TALICIA for H. pylori infection. Following several modifications to our NPV aligning with RedHill’s latest R&D update, we value the company at $410m or $19.2/ADS (vs $21.1/ADS).

RedHill Biopharma

Successful Phase II with BEKINDA for IBS-D

Update | Pharmaceuticals & healthcare | 27 Nov 2017

In October 2017, RedHill announced that one of its core assets, BEKINDA, significantly alleviated symptoms of patients with diarrhoea-predominant irritable bowel syndrome (IBS-D) in a Phase II trial. Although not comparable directly, the data look good in relation to two other recent drugs, Viberzi and Xifaxan, which had combined sales of $382m in 2016 after the launch in 2015 for this indication. We have increased our success probability for BEKINDA in IBS-D and now value RedHill at $449m or $21.1/ADS.

RedHill Biopharma

First sales of GI specialty products

Update | Pharmaceuticals & healthcare | 22 Aug 2017

RedHill’s strategy to diversify into commercial specialty pharma business has born first fruits with initial sales booked in Q217, in line with previously guided timelines to initiate the marketing activities. The US organisation is now fully set up and markets two GI products: Donnatal (co-promoted with Concordia Healthcare) and EnteraGam (exclusive licence to sell from Entera Health). We now include the two products in our RedHill valuation, which is increased to $414m or $23.4/ADS. Notably, RedHill recently added a third product, Esomeprazole Strontium, to its US portfolio, which we could potentially add to our valuation assuming successful initiation of promotional activities in coming weeks.

RedHill Biopharma

Positive Phase III with BEKINDA for gastroenteritis

Update | Pharmaceuticals & healthcare | 17 Jul 2017

RedHill BioPharma delivered a flurry of news recently, including a major R&D milestone when a Phase III trial with BEKINDA 24mg showed that the drug was beneficial to gastroenteritis/gastritis patients. There are several inflection points still to come in 2017: a data readout from the BEKINDA Phase II trial with IBS-D patients, a second DSMB review of RHB-104 Phase III in Crohn's disease trial with an early termination option, and the meeting with the FDA to decide the further strategy with BEKINDA for gastroenteritis. We have increased our valuation to $390m (NIS1.42bn).

RedHill Biopharma

Seeking recurring revenues; two readouts in 2017

Update | Pharmaceuticals & healthcare | 24 May 2017

RedHill's Q117 business update described steady progress on both fronts: the R&D pipeline and planned commercialisation of the two products for gastrointestinal (GI) diseases via co-promotion or in-licensing deals. The initiation of promotional activities is expected in Q217 and data readouts from two mid- to late-stage clinical trials in Q2/Q317 will provide inflection points this year. Our valuation is slightly higher at NIS1.40bn ($378m).

RedHill Biopharma

Second GI product added to commercial portfolio

Flash note | Pharmaceuticals & healthcare | 06 Apr 2017

Yesterday RedHill announced an agreement with US-based medical food developer and manufacturer Entera Health for exclusive rights to market EnteraGam in the US. In exchange, RedHill will pay tiered royalties, but notably no upfront or milestone payments. EnteraGam is an FDA-regulated medical food intended for the dietary management of chronic diarrhoea and has to be administered under medical supervision. This is the second product RedHill has added to its commercial portfolio after the co-promotion deal for Donnatal with Concordia Healthcare in January 2017.