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Portfolio progress continues

Clal Biotechnology Industries 6 June 2018 Update (1-4pgs)
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Clal Biotechnology Industries

Portfolio progress continues

Financial update

Pharma & biotech

6 June 2018

Price*

NIS2.93

Market cap

NIS459m

*Priced at 31 May 2018

NIS3.56/US$

Net cash ($m, unconsolidated) at 31 March 2018

4.3

Shares in issue

156.5m

Free float

35.3%

Code

CBI

Primary exchange

TASE

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

6.1

(7.6)

(31.8)

Rel (local)

3.2

(7.8)

(35.2)

52-week high/low

NIS4.2

NIS2.7

Business description

Clal Biotechnology Industries is a healthcare investment company focused on investing in a variety of therapeutic, diagnostic and medical device companies covering a full range of development phases from preclinical to post-market. The company holds 10 direct investments, with interests ranging between 5% and 70%. It also has five indirect investments through its 50% stake in the Anatomy Fund, which it manages.

Next events

Gamida Cell IPO

H218

MediWound NexoBrid Phase III results

YE18

MediWound EscharEx Phase III initiation

YE18

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Clal Biotechnology Industries’ (CBI) portfolio of investments continues to demonstrate forward-looking business development and clinical progress. Notably, MediWound announced in May that it is now in discussions with multiple third parties interested in a strategic transaction. Still, the nature of these approaches remains unclear. Also, BioCanCell announced a $23m private equity investment and plans to use the proceeds to initiate two studies for its lead programme. Lastly, Neon filed a prospectus with the SEC detailing an IPO expected to raise ~$100m on NASDAQ.

Year end

Revenue (NISm)

PBT* (NISm)

EPS* (NIS)

DPS (NIS)

P/E (x)

Yield (%)

12/15

55.8

(209.4)

(1.44)

0.0

N/A

N/A

12/16

30.5

(454.1)

(2.89)

0.0

N/A

N/A

12/17

73.6

(54.2)

(0.15)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Multiple potential suitors for MediWound

MediWound (35% owned by CBI) recently announced its Q118 results. Revenues, which are based on NexoBrid sales in the EU, were $0.5m, which is in line with the same period in 2017. The company announced that it has received additional offers from multiple third parties interested in a strategic transaction and it is now in discussions with various parties. The exact nature of the proposed transactions remains unclear, but could include a sale or an out-licensing agreement.

BioCanCell announces $23m private equity financing

BioCanCell announced the signing of a $22.9m private equity investment and intends to use these funds to initiate two registrational studies. To meet TASE regulations, CBI sold approximately 7.5m shares (~NIS8m) in BioCanCell to an Israeli institutional investor, thus decreasing CBI’s ownership of BioCanCell to 36% (from 44%). CBI provided the company with a $3m bridge loan to be repaid when the transaction closes. It is likely that CBI’s stake will decrease to 30% at closing.

Clinical progress at Biokine

Biokine’s (27% owned by CBI) partner BioLineRx reported top-line results from two of its trials: its 24-donor/recipient patient pair single-arm Phase II trial to evaluate BKT-140/BL-8040 as monotherapy for mobilisation of hematopoietic stem and progenitor cells (HSPCs) and its 42-patient, single-arm, Phase IIa clinical trial evaluating BL-8040 in combination with high-dose cytarabine (HiDAC) in patients with relapsed/refractory acute myeloid leukaemia (AML). The data will be presented at the European Hematology Association (EHA) annual meeting in June.

Valuation: NIS958m or NIS6.13 per share

We have adjusted our valuation to NIS958m or NIS6.13 per share from NIS1,011m or NIS6.46 per share. This was mainly due to decreasing the value of CBI’s BioCanCell stake due to dilution from the financing round, as well as the decrease in CBI’s cash balance at the corporate level.

Business development and clinical progress

In May, MediWound announced that it is now engaged in discussions with multiple third parties interested in a strategic transaction. According to the company, these additional approaches are preliminary, while advanced discussions and mutual due diligence are ongoing with the initial third party, which approached in March. Again, the exact nature of these proposed transactions was not disclosed, but could include anything from a product out-licensing to the acquisition of all of MediWound. If it does involve licensing the rights to a MediWound product, we believe it would likely be for EscharEx, which has a larger addressable market than NexoBrid. It is important to note that we do not currently include any upfront or milestone payments in our EscharEx model, so a licensing agreement could have significant impact on our valuation of the product. Discounting any additional interest, MediWound expects to provide more details regarding the path forward in the coming months. We will update our model once an agreement, if any, is finalised.

In terms of the underlying business, MediWound recently reported its Q118 results. Revenues, which are based on NexoBrid sales in the EU were $0.5m, in line with Q117. According to the company, all clinical development will continue to progress independently of such strategic discussions. The 175-patient US NexoBrid Phase III trial is likely to complete enrolment by mid-2018 with top-line results expected around year-end. The company plans to file a BLA in H219 with these data and further supplement the application with 12-month follow-up data during FDA review. Additionally, the company expects to initiate enrolment for the 160-paedatric patient Phase III NexoBrid study in the US following IRB approval, which is expected in Q218. In June, MediWound received authorisation from South Korea’s Ministry of Health to market and distribute NexoBrid via the BL&H Company as an exclusive distributor. The company intends to launch NexoBrid in South Korea in H218.

With regards to EscharEx, the company expects to submit the Phase III protocol to the FDA in H218, with the actual initiation of the study likely sometime around the end of 2018 or the beginning of 2019. Also, the company announced that after speaking with regulatory experts, it believes the Phase III programme might only need 500 patients across two studies (250 each study), 200 fewer than the previous expectations of 700 (350 each study). If the FDA agrees, this could lead to significant R&D cost savings for the EscharEx programme.

Furthermore, the company announced the opening of a new NexoBrid development programme for the treatment of skin injuries caused by chemical warfare agents, such as sulphur mustard. Exposure to sulphur mustard liquid can cause skin blistering as well as second- and third-degree burns.1 Preliminary results from porcine studies were presented at the European Burn Association Congress in September 2017. This product will likely be developed via the FDA animal rule, which allows for approval based on animal studies for conditions that cannot feasibly be studied in human clinical trials. The company expects to solidify a development plan following FDA guidance and we will update our model to include this programme at that time.

  CDC.

BioCanCell private equity investment

In April, BioCanCell announced the signing of a $22.9m private equity investment in the company. The financing was led by Shavit Capital, an Israeli private equity fund, and was joined by CBI ($3.0m) as well as other new and existing US and Israeli investors. In order to meet TASE regulations, CBI sold approximately 7.5m shares in BioCanCell for NIS8m to Yelin Lapidot, an Israeli institutional investor. Following this transaction, CBI’s ownership of BioCanCell has decreased to 36% (from 44%). CBI also provided BioCanCell with a $3m bridge loan to be repaid when the deal closes. Furthermore, CBI will invest $5m in the private equity investment and upon completion CBI’s ownership will fall to 30%. BioCanCell intends to use these funds to initiate two registrational studies for its lead programme, BC-819 in non-muscle invasive bladder cancer (NMIBC).

As a reminder, BioCanCell plans to initiate two pivotal clinical trials in 2018. BC-204 will be an open-label, Phase II single-arm trial in 140 patients who are unresponsive to Bacillus Calmette-Guerin (BCG) therapy and the primary end point is durable response rate (either partial or complete) at 12 months. It is expected to begin in H118. BC-301 will be an open-label, Phase III trial in approximately 495 patients of BC-819 in combination with BCG versus BCG alone and is expected to begin in H218. The BC-301 trial has been granted a special protocol assessment by the FDA and the primary end point is median time to recurrence. The BC-301 trial will be the first comparative study and we expect the results to elucidate the clinical value of BC-819 for NMIBC.

Biokine clinical progress

In May, Biokine’s (27%-owned by CBI) partner, BioLineRx, reported partial results from its 24-donor/recipient patient pair single-arm Phase II trial to evaluate BKT-140/BL-8040 as monotherapy for mobilisation of HSPCs for allogenic transplantation. For the first part of the study, HLA-identical donors received a single dose of 1 mg/kg of BL-8040. Of the 21 evaluable donors that have been enrolled to date, 11 out of 13 donors achieved the primary end point, which was HSPC collection of ≥2×106 CD34 cells/kg of recipient weight in up to two leukapheresis sessions. For the second half of the study, which remains ongoing and includes HLA-identical pairs as well as haploidentical pairs (ie not fully matched), donors were treated with 1.25 mg/kg of BL-8040. Eight out of 8 donors reached the primary end point and this part of the trial remains ongoing. In both cases, BL-8040 was determined to be safe and well tolerated, while adverse events included injection site reactions and transient systemic reactions, which have since been resolved. Thirteen of the 19 successful transplanted recipients reached the secondary end point, which was 100 days post-transplant. The company expects to report on the full effect of BL-8040 on graft-versus-host disease (GVHD) when the data become available at a later date.

BioLineRx also reported top-line results from its 42-patient single-arm Phase IIa clinical trial evaluating BL-8040 in combination with HiDAC in patients with relapsed/refractory AML. The study was divided into a dose-escalation cohort (0.5–2.0 mg/kg) and a dose-expansion cohort (1.5mg/kg) and patients were treated with BL-8040 monotherapy for two days followed by combination BL-8040 and HiDAC therapy (select end points illustrated in Exhibit 1). These early data will also support its ongoing Phase I/IIa trial collaboration with Genentech, investigating the combination of BL-8040 with Tecentriq (atezolizumab), the anti-PDL1 immunotherapy for AML. BioLineRx will present data from the two studies at a European medical conference in June.

Exhibit 1: Select end points from Phase IIa evaluation of BL-8040 with HiDAC

All doses tested (n=42)

Dose-expansion cohort (n=23)

Response rate

29%

39%

Median overall survival

9.1 months

9.2 months

1-year survival rate

N/A

31.6%

2-year survival rate

N/A

21.1%

Source: BioLineRx. Notes: Response rate= complete response/incomplete hematologic recovery.

Clinical progress and a NASDAQ IPO filing for NEON

Neon (5% owned by CBI) released interim results from the NT-001 trial, a single-arm Phase Ib trial investigating the safety and immunogenicity of NEO-PV-01, a personalised cancer vaccine, in combination with Bristol-Myers Squibb’s Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, for the treatment of metastatic melanoma, non-small cell lung cancer (NSCLC) and bladder cancer. Neon has reduced target enrolment to 45 patients (from 90 patients) and expects more than half to be melanoma patients. As a reminder, patients will be administered Opdivo at a dose of 240mg by intravenous infusion over 30 minutes every two weeks for 12 weeks. Regardless of disease status, all patients will receive NEO-PV-01 + adjuvant administered subcutaneously in up to four sites (extremity or flanks) while continuing with Opdivo treatment, again for 12 weeks, after which Opdivo therapy will continue until disease progression. As of 31 March 2018, NEO-PV-01 dosing has been initiated in 31 patients and no serious adverse events were observed. Of the 19 patients who have completed the full vaccination course, 10 patients (eight melanoma, one NSCLC, and one bladder cancer) had partial response and three patients (melanoma) achieved stable disease (RECIST criteria). In all three tumour types, administration of NEO-PV-01 was associated with de novo immune responses to approximately 60% of immunising peptides. Additionally, in seven of the 11 patients where biopsies were available, no histologic evidence of tumour was observed in post-vaccine biopsies. The company expects to report one-year follow-up results in H119.

Neon also announced that it has initiated a 15-patient, open-label single-arm Phase Ib for NEO-PV-01 in combination with Merck’s KEYTRUDA (pembrolizumab), a PD-1 immune checkpoint modulator in patients with previously untreated or advanced non-squamous non-small cell lung cancer. One-year follow-up results are expected in H219. The company also plans to initiate the Phase Ib trial investigating NEO-PV-01 in combination with Apexigen’s anti-CD40 antibody (APX005M) or a CTLA-4 antagonist in patients with metastatic melanoma in H218.

Furthermore, the company plans to file an application in Europe in H119 to conduct a trial in patients with solid tumours with their T-cell based therapy, NEO-PTC-01. Additionally, Neon expects to file an IND in H119 to investigate NEO-SV-01, an off-the-shelf peptide vaccine, in the treatment of oestrogen-receptor positive (ER+) breast cancer in the US. And lastly on 31 May 2018, Neon filed a draft prospectus with the SEC detailing an IPO expected to raise ~$100m on the NASDAQ under the symbol NTGN. Morgan Stanley, Bank of America/Merrill Lynch and Mizuho are acting as joint book-running managers.

Update on rest of portfolio

In March, Gamida Cell (18% owned by CBI) presented data on immune reconstitution (IR) from a random cohort of 22 patients (median age 41.5 years) with hematologic malignancies from its Phase I/II study of NiCord as a graft after myeloablative chemotherapy at the meeting of the European Society for Blood and Marrow Transplantation. Delayed IR following cord blood transplantation is associated with significant morbidity (ie increased risks of infections, relapse, development of secondary malignancies) and mortality.2, 3 IR is affected by human leukocyte antigen (HLA) discrepancy between donor and host, GVHD, preparative radiation/chemotherapy regimens and age-related thymic involution.4 Data from this cohort were compared to subgroups of patients with hematologic malignancies receiving non-manipulated cord blood transplantation (n=27, median age 15.4 years) and T-cell-replete, unrelated bone marrow transplantation (n=20, median age 14.3 years). More than 90% of the patients achieved the primary end point, which was defined as successful CD4+ IR (>50×106/L) within the first 100 days following NiCord transplantation. The secondary end points were IR of CD4+, CD8+, natural killer (NK) cells, B-cells and monocytes during the first year after transplantation. The study found that IR of NK cells (p<0.001), B-cells (p=0.026) and monocytes (p<0.001) after NiCord transplantation was faster in comparison to the other subgroups.

  M. R. M. Van Den Brink, Velardi, E., & Perales, M. (2015). Immune reconstitution following stem cell transplantation. Hematology,2015(1), 215-219.

  Komanduri, K. V., et al. (2007). Delayed immune reconstitution after cord blood transplantation is characterized by impaired thymopoiesis and late memory T-cell skewing. Blood,110(13), 4543-4551.

  Lucchini, G., Perales, M., & Veys, P. (2015). Immune reconstitution after cord blood transplantation: Peculiarities, clinical implications and management strategies. Cytotherapy,17(6), 711-722.

Furthermore, Pi-Cardia recently announced the initiation of its first in-human study with its lead product, Leaflex. The device is a low-profile catheter to treat aortic stenosis without replacing the valve that uses mechanical energy to create fractures in valve calcifications. thereby increasing the orifice area.

Exhibit 2: CBI’s key investments

Investment

Technology

% held

Founded

Status

Advantages

Targets

MediWound*

Enzyme technology for severe burns and chronic wounds

35%

2001

NexoBrid: launched in Europe; in Phase III development in the US EscharEx: Phase II complete

Reduces time to successful eschar removal, reduces need for surgery and need for grafting

NexoBrid Phase III study readout YE18; EscharEx Phase III trial initiation in end of 2018 or beginning of 2019

Gamida Cell*

Cord stem cell transplant for hematologic diseases

18%

1998

NiCord: enrolling Phase III; CordIn: two ongoing Phase I/II trials; NK cells: initiated Phase I

UCB for transplantation only requires partial matching and nicotinamide technology increases the limited population and quality of stem and progenitor cells. NiCord received FDA breakthrough therapy designation

Enrolment is underway for a Phase III study of NiCord; NASDAQ listing targeted for H218

BioCanCell

BC-819 is a DNA plasmid for non-muscle invasive bladder cancer

36%

2004

Ongoing Phase II BC-819 and BCG combination trial

BC-819 is a 4.5 kb recombinant DNA plasmid containing H19 regulatory sequences that drives expression of the potent diphtheria toxin A and inhibits protein translation in malignant bladder cells. Monotherapy clinical studies demonstrated promising efficacy rates

Initiate two (monotherapy and combination therapy) pivotal clinical trials in 2018. NASDAQ listing targeted for H218

Biokine

Cyclic peptide inhibitor of CXCR4 for AML and other malignancies

27%

2000

Phase III in stem cell mobilisation. Phase II in relapsed/ refractory AML with BioLineRx; Phase Ib/II: collaboration with Genentech, combination BKT-140/BL-8040 and Tecentriq (atezolizumab) for multiple oncology indications

Phase I/II trials showed vigorous mobilisation of CD34+ stem and progenitor cells from the bone marrow, inducing cell death and sensitising the malignant cells to anti-cancer therapies

Phase II mobilisation results for BL-8040 in H118. Phase II pancreatic results in H218

Source: Clal Biotechnology Industries. Notes: *Material assets according to CBI. All key investments included in our rNPV.

Exhibit 3: CBI’s direct holdings

Investment

Technology

% held

Founded

Status

Advantages

Targets

eXIthera

Factor XIa inhibition to prevent thrombosis and stroke

54%

2012

Phase I: Safety, tolerability, PK, PD of parenteral EP-7041

Positive Phase I dose escalation readout showed EP-7041 was safe and well tolerated in healthy volunteers and also demonstrated positive PK and PD data

Potential licensing deal for EP-7041 in H118. Phase II initiation in H218. Selection of oral candidate expected in coming months

Vedantra

Cancer and infectious disease immunotherapy

66%

2011

Preclinical

Engineering a molecular vaccine that possesses both hydrophilic and hydrophobic properties (amph-vaccine) to exploit albumin to transport small payloads to the lymph node to initiate effective T- and B-cell responses

Amphiphile technology-based HPV vaccine for the treatment of HPV-related head and neck malignancies expected in the clinic in H118

Neon

Personalised neoantigen therapeutics for cancer

5%

2015

Phase I: NEO-PV-01 and OPDIVO combination therapy

Phase I: NEO-PV-01 and combination with KEYTRUDA and chemotherapy

Initial results published in Nature. Several collaborations in the pipeline with large pharma, academic institutions, and other clinical stage biopharmaceutical companies. Recently completed a $106m crossover Series B financing

Potential NASDAQ listing in H218; NEO-PV-01 and OPDIVO combination results expected H119; NEO-PV-01 and KEYTRUDA combination results expected H119

Cadent

Treatment of CNS disorders by targeting calcium-sensitive potassium (SK) channels

24%

2010

Phase I: NMDAR2B NAM molecule for treatment of treatment-resistant depression out-licensed to Novartis

Phase I: CD-1883 for spinocerebellar ataxia and essential tremor.

CD-1883 increases the sensitivity of SK channels that play an essential role in regular neuronal firing with the intent to restore regularity and improve motor function

Potential NASDAQ listing in H218

Source: Clal Biotechnology Industries. Notes: DIPG = diffuse intrinsic pontine glioma, CXCR4 = CXC- chemokine receptor-4 pathway, AML = acute myeloid leukaemia, NMDAR = N-methyl-D-aspartate receptor subtype 2B; NAM= negative allosteric modulator.

Exhibit 4: CBI’s indirect holdings through 50% stake in Anatomy

Investment

Technology

Anatomy investments at fair value to CBI ($m)

Founded

Status

Advantages

Targets

FDNA

Genetic disease diagnostics with facial recognition

1.1

2011

Market

Combines computer vision, machine learning and artificial intelligence to analyse facial features, genomic data, and patient symptoms

Innovation needs to be linked to clinical outcomes

Sight Diagnostics

Computer vision point-of-care blood diagnostics system

1.0

2011

Parasight: Market; OLO: Pivotal trial

Point-of-care full complete blood count system

OLO: Clinical validation and commercial test development. FDA approval

Colospan

Developing bypass device (CG-100) for colorectal surgery

1.6

2010

CE approved in Europe.

Prevents life threatening leakage and makes it possible to cut down the use of stomas. Positive initial clinical results

CG-100: Soft launch in Europe in 2018 for market feasibility. Recruiting approximately 137 patients to participate in the safety and efficacy trial through H219 and expects to file for FDA marketing approval following trial results

MinInvasive

Device for arthroscopic rotator cuff repair

1.6

2011

Market

Needle-based shoulder tendon repair device that eliminates the need for suture anchors

MicroPort granted exclusive rights to distribute device in China. FDA cleared and anticipating US launch

Pi-Cardia*

Non-implant based technology for aortic valve stenosis

1.6

2009

Clinical

Developed a low profile catheter to treat aortic stenosis without replacing the valve

Clinical validation

Total, including $1.5m in additional investments

8.5**

Source: Clal Biotechnology Industries. Note: *as of year-end 2017. **Pi-Cardia is also held directly (21% stake includes direct costs of CBI and 50% stake in Anatomy).

 

Valuation

We are decreasing our valuation to NIS958m or NIS6.13 per share from NIS1,011m or NIS6.46 per share. This was mainly due to the lower value of the BioCanCell stake (from 44% to 36%), which fell from $62.4m to $51.1m following the April 2018 private equity investment in the company and the decrease in CBI’s cash position at the corporate level. We expect to update our valuation of MediWound further once we get more information about the discussions with the potential strategic partners. We also note that our valuation may change as a result of CBI’s potential participation in future tranches of BioCanCell’s ongoing funding round.

Exhibit 5: CBI valuation breakdown

Product

Setting

Status

Launch

Peak sales ($m)

Probability of success

Royalty rate

rNPV ($m)

% owned by Clal B

Clal B rNPV ($m)

MediWound

Burns

Market and Phase III ready

Nexobrid: Market, EscharEx: Phase III

375

Nexobrid US 80%, Europe 100%, EscharEx 50%

Nexobrid: 100% EscharEx: 20%

207

35%

72.4

Gamida Cell

Leukaemia (AML, ALL, CML, CLL)

Phase III

2020

437

50%

100%

423

18%

76.1

Biokine

AML

Phase II

2023

1,286

30%

40% of what BioLineRx receives from a sublicense (assume 20%)

43

27%

11.6

BioCanCell

Bladder cancer

Phase II and Phase III ready

2022

530

30%

100%

142

36%

51.1

Neon

5%

12.4

Vedantra

66%

9.1

ExlThera

54%

10.3

Cadent

24%

18.0

Anatomy portfolio

8.5

Portfolio total ($m)

269

Cash, unconsolidated (As of 31 March 2018) ($m)

4

Overall valuation

285

Shekel/dollar conversion rate

3.5

Overall valuation in shekels (NISm)

958

Shares outstanding (m)

156.5

Per share (NIS)

6.13

Source: Edison Investment Research, Clal Biotechnology Industries reports

Financials

As a reminder, due to significant ownership stakes, CBI consolidates the financials of several of its investments (MediWound, Vedantra, CureTech and the Anatomy fund) and on this basis, it had NIS140.1m ($40.0) in cash, cash equivalents and bank deposits as of Q118. CBI’s cash position at the corporate level (excluding consolidation) was NIS15.2m ($4.3m) at 31 March 2018. We also note that CBI provided BioCanCell with a $3m bridge loan ($2m paid by 31 March 2018), which will be repaid at the closing of the private equity transaction.

Total consolidated revenues of NIS2.2m ($0.6m) were generated through the sales of MediWound’s NexoBrid in Europe, Israel and Argentina, licensing agreements and rent, in addition to NIS1.6m ($0.5m) from the decrease of equity interest in associates in Q118.

Substantial investment was made into the development of underlying technologies and products of CBI’s material assets, as indicated by R&D spend of NIS7.6m ($2.2m), which is down from NIS11.6m ($3.3m) for the same period in 2017. For the period, general and admin costs, which include payroll and related expenses, management fees, and marketing and advertising expenses on a consolidated basis, were NIS17.5m ($5.0m).

We outline historical financials in Exhibit 6; however, we are not providing forecasts at this time.

Exhibit 6: Financial summary

NIS000s

2015

2016

2017

Year-end 31 December

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

55,759

30,484

73,635

Cost of Sales

(42,549)

(46,967)

(32,433)

Gross Profit

13,210

(16,483)

41,202

R&D expenses

(54,094)

(42,011)

(32,644)

SG&A expenses

(82,747)

(81,107)

(61,679)

EBITDA

 

 

(175,382)

(434,812)

(103,330)

Operating Profit (before amort. and except.)

 

(179,999)

(451,764)

(103,633)

Intangible Amortisation

0

0

0

Exceptionals

0

0

0

Operating Profit

(179,999)

(451,764)

(103,633)

Other

(35,553)

(11,850)

(31,078)

Net Interest

6,197

9,510

80,478

Profit Before Tax (norm)

 

 

(209,355)

(454,104)

(54,233)

Profit Before Tax (FRS 3)

 

 

(209,355)

(454,104)

(54,233)

Tax

14,023

60,104

31,795

Profit After Tax (norm)

(195,332)

(394,000)

(22,438)

Profit After Tax (FRS 3)

(195,332)

(394,000)

(22,438)

Average Number of Shares Outstanding (m)

135.8

136.2

149.4

EPS - normalised (NIS)

 

 

(1.44)

(2.89)

(0.15)

EPS - FRS 3 (NIS)

 

 

(1.44)

(2.89)

(0.15)

Dividend per share (NIS)

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,225,127

927,359

849,112

Intangible Assets

1,035,753

741,543

626,342

Tangible Assets

17,077

16,536

14,854

Other

172,297

169,280

207,916

Current Assets

 

 

307,645

191,351

185,228

Stocks

6,691

3,248

6,539

Debtors

18,784

16,415

13,612

Cash

256,105

171,022

165,077

Other

26,065

666

0

Current Liabilities

 

 

(66,785)

(68,277)

(31,182)

Creditors

(14,782)

(8,507)

(7,975)

Short term borrowings

0

0

0

Short term leases

0

0

0

Other

(52,003)

(59,770)

(23,207)

Long Term Liabilities

 

 

(373,520)

(297,938)

(194,962)

Long term borrowings

0

0

0

Long term leases

0

0

0

Other long term liabilities

(373,520)

(297,938)

(194,962)

Net Assets

 

 

1,092,467

752,495

808,196

CASH FLOW

Operating Cash Flow

 

 

(156,274)

(52,529)

(59,400)

Net Interest

23,298

0

0

Tax

(14,023)

(60,104)

(32,005)

Capex

0

0

0

Acquisitions/disposals

27,971

(395)

(3,876)

Financing

22,499

23,123

80,611

Dividends

0

0

0

Other

146,116

5,447

72,644

Net Cash Flow

49,587

(84,458)

57,974

Opening net debt/(cash)

 

 

(207,517)

(256,105)

(171,022)

HP finance leases initiated

0

0

0

Other

(999)

(625)

(10,253)

Closing net debt/(cash)

 

 

(256,105)

(171,022)

(218,743)

Source: Edison Investment Research, Clal Biotechnology Industries reports

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Pty Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

EDISON ISRAEL DISCLAIMER

Disclosure regarding the scheme to enhance the awareness of investors to public companies in the technology and biomed sectors that are listed on the Tel Aviv Stock Exchange and participate in the scheme (hereinafter respectively “the Scheme”, “TASE”, “Participant” and/or “Participants”). Edison Investment Research (Israel) Ltd, the Israeli subsidiary of Edison Investment Research Ltd (hereinafter respectively “Edison Israel” and “Edison”), has entered into an agreement with the TASE for the purpose of providing research analysis (hereinafter “the Agreement”), regarding the Participants and according to the Scheme (hereinafter “the Analysis” or “Analyses”). The Analysis will be distributed and published on the TASE website (Maya), Israel Security Authority (hereinafter “the ISA”) website (Magna), and through various other distribution channels. The Analysis for each participant will be published at least four times a year, after publication of quarterly or annual financial reports, and shall be updated as necessary after publication of an immediate report with respect to the occurrence of a material event regarding a Participant. As set forth in the Agreement, Edison Israel is entitled to fees for providing its investment research services. The fees shall be paid by the Participants directly to the TASE, and TASE shall pay the fees directly to Edison. Subject to the terms and principals of the Agreement, the Annual fees that Edison Israel shall be entitled to for each Participant shall be in the range of $35,000-50,000. As set forth in the Agreement and subject to its terms, the Analyses shall include a description of the Participant and its business activities, which shall inter alia relate to matters such as: shareholders; management; products; relevant intellectual property; the business environment in which the Participant operates; the Participant's standing in such an environment including current and forecasted trends; a description of past and current financial positions of the Participant; and a forecast regarding future developments in and of such a position and any other matter which in the professional view of the Edison (as defined below) should be addressed in a research report (of the nature published) and which may affect the decision of a reasonable investor contemplating an investment in the Participant's securities. To the extent it is relevant, the Analysis shall include a schedule of scientific analysis of an expert in the field of life sciences. An "equity research abstract" shall accompany each Equity Research Report, describing the main points addressed. The full scope reports and reports where the investment case has materially changed will include a thorough analysis and discussion. Short update notes, where the investment case has not materially changed, will include a summary valuation discussion. The Agreement with TASE regarding the participation of Edison in the scheme for the research analysis of public companies does not and shall not constitute an approval or consent on the part of TASE or the ISA or any other exchange on which securities of the Company are listed, or any other securities’ regulatory authority which regulates the issuance of securities by the Company to the content of the Report or to the recommendation contained therein. A summary of this report is also published in the Hebrew language. In the event of any contradiction, inconsistency, discrepancy, ambiguity or variance between the English Report and the Hebrew summary of said Report, the English version shall prevail; and a note to this effect shall appear in any Hebrew summary of a Report. Edison is regulated by the Financial Conduct Authority. According to Article 12.3.2, Chapter 12 of the Conduct of Business Sourcebook, Edison, which produces or disseminates non-independent research, must ensure that it: 1) is clearly identified as a marketing communication; and 2) contains a clear and prominent statement that (or, in the case of an oral recommendation, to the effect that) it: a) has not been prepared in accordance with legal requirements designed to promote the independence of investment research; and b) is not subject to any prohibition on dealing ahead of the dissemination of investment research. The financial promotion rules apply to non-independent research as though it were a marketing communication.

EDISON INVESTMENT RESEARCH DISCLAIMER

Copyright 2018 Edison Investment Research Limited. All rights reserved. This report has been prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Investment Research Pty Limited (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research. Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2018. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Tel Aviv +44 (0)20 3734 1007 Medinat Hayehudim 60

Herzilya Pituach, 46766

Israel

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Tel Aviv +44 (0)20 3734 1007 Medinat Hayehudim 60

Herzilya Pituach, 46766

Israel

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Pty Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

EDISON ISRAEL DISCLAIMER

Disclosure regarding the scheme to enhance the awareness of investors to public companies in the technology and biomed sectors that are listed on the Tel Aviv Stock Exchange and participate in the scheme (hereinafter respectively “the Scheme”, “TASE”, “Participant” and/or “Participants”). Edison Investment Research (Israel) Ltd, the Israeli subsidiary of Edison Investment Research Ltd (hereinafter respectively “Edison Israel” and “Edison”), has entered into an agreement with the TASE for the purpose of providing research analysis (hereinafter “the Agreement”), regarding the Participants and according to the Scheme (hereinafter “the Analysis” or “Analyses”). The Analysis will be distributed and published on the TASE website (Maya), Israel Security Authority (hereinafter “the ISA”) website (Magna), and through various other distribution channels. The Analysis for each participant will be published at least four times a year, after publication of quarterly or annual financial reports, and shall be updated as necessary after publication of an immediate report with respect to the occurrence of a material event regarding a Participant. As set forth in the Agreement, Edison Israel is entitled to fees for providing its investment research services. The fees shall be paid by the Participants directly to the TASE, and TASE shall pay the fees directly to Edison. Subject to the terms and principals of the Agreement, the Annual fees that Edison Israel shall be entitled to for each Participant shall be in the range of $35,000-50,000. As set forth in the Agreement and subject to its terms, the Analyses shall include a description of the Participant and its business activities, which shall inter alia relate to matters such as: shareholders; management; products; relevant intellectual property; the business environment in which the Participant operates; the Participant's standing in such an environment including current and forecasted trends; a description of past and current financial positions of the Participant; and a forecast regarding future developments in and of such a position and any other matter which in the professional view of the Edison (as defined below) should be addressed in a research report (of the nature published) and which may affect the decision of a reasonable investor contemplating an investment in the Participant's securities. To the extent it is relevant, the Analysis shall include a schedule of scientific analysis of an expert in the field of life sciences. An "equity research abstract" shall accompany each Equity Research Report, describing the main points addressed. The full scope reports and reports where the investment case has materially changed will include a thorough analysis and discussion. Short update notes, where the investment case has not materially changed, will include a summary valuation discussion. The Agreement with TASE regarding the participation of Edison in the scheme for the research analysis of public companies does not and shall not constitute an approval or consent on the part of TASE or the ISA or any other exchange on which securities of the Company are listed, or any other securities’ regulatory authority which regulates the issuance of securities by the Company to the content of the Report or to the recommendation contained therein. A summary of this report is also published in the Hebrew language. In the event of any contradiction, inconsistency, discrepancy, ambiguity or variance between the English Report and the Hebrew summary of said Report, the English version shall prevail; and a note to this effect shall appear in any Hebrew summary of a Report. Edison is regulated by the Financial Conduct Authority. According to Article 12.3.2, Chapter 12 of the Conduct of Business Sourcebook, Edison, which produces or disseminates non-independent research, must ensure that it: 1) is clearly identified as a marketing communication; and 2) contains a clear and prominent statement that (or, in the case of an oral recommendation, to the effect that) it: a) has not been prepared in accordance with legal requirements designed to promote the independence of investment research; and b) is not subject to any prohibition on dealing ahead of the dissemination of investment research. The financial promotion rules apply to non-independent research as though it were a marketing communication.

EDISON INVESTMENT RESEARCH DISCLAIMER

Copyright 2018 Edison Investment Research Limited. All rights reserved. This report has been prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Investment Research Pty Limited (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research. Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2018. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Tel Aviv +44 (0)20 3734 1007 Medinat Hayehudim 60

Herzilya Pituach, 46766

Israel

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Tel Aviv +44 (0)20 3734 1007 Medinat Hayehudim 60

Herzilya Pituach, 46766

Israel

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