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A licensing deal for MediWound

Clal Biotechnology Industries 19 June 2019 Update
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Clal Biotechnology Industries

A licensing deal for MediWound

Development update

Pharma & biotech

19 June 2019

Price*

NIS2.26

Market cap

NIS364m

*Priced at 17 June 2019

NIS3.62/US$

Net debt (NISm, unconsolidated) at
31 March 2019

12.3

Shares in issue

161.2m

Free float

37.2%

Code

CBI

Primary exchange

TASE

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(11.2)

(20.9)

(32.0)

Rel (local)

(10.2)

(21.4)

(34.1)

52-week high/low

NIS3.7

NIS2.3

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 nine direct investments, with interests ranging between 4% and 54%. It also has five indirect investments through its 50% stake in the Anatomy Fund, which it manages.

Next events

MediWound to file BLA for NexoBrid

Q419

Gamida Cell NiCord Phase III top-line data

H120

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Clal Biotechnology Industries (CBI) recently published its first quarter update. Notably, MediWound has licensed North American commercialisation rights for NexoBrid to Vericel for $17.5m upfront, with an additional $132.5m in potential milestones. Also, Gamida Cell is on track to complete enrolment for its Phase III trial of NiCord (now called omidubicel) in haematological malignancies in H219 with data expected in H120. In addition, Cadent received a $15m milestone payment from Novartis as MIJ821 (CAD-9271) for treatment-resistant depression entered Phase II.

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

12/18

85.3

(40.9)

(0.18)

0.0

N/A

N/A

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

MediWound licenses NexoBrid

In May, MediWound (35% owned by CBI) announced it has licensed the North American commercialisation rights of NexoBrid to Vericel for $17.5m upfront and a total of $132.5m in potential milestones including $7.5m upon FDA approval. Royalties will range from single digits to low double digits (we are modelling 8–12% royalties). The company expects to file for approval in Q419. MediWound also announced that it will continue to seek partners outside of North America for NexoBrid, which could provide some additional funding.

BARDA commits an additional $21m for NexoBrid

Also in May, MediWound announced that the US Biomedical Advanced Research and Development Authority (BARDA) upsized its awarded contract with the company by $21m to initiate a NexoBrid expanded access treatment protocol (NEXT) in burn patients. Total non-dilutive funding from BARDA can now total up to $196m, with $31m provided as of the end of Q119.

Gamida Cell Phase III data next year

Gamida Cell (12% owned by CBI) is on track to complete enrolment for its Phase III trial of NiCord (now called omidubicel) in haematological malignancies in H219 with data expected in H120. If these Phase III data are positive, Gamida Cell plans to submit a biologic licence application (BLA) filing for omidubicel in H220.

Valuation: NIS736m or NIS4.56 per share

We have decreased our valuation of CBI from NIS850m or NIS5.27 per share to NIS736m or NIS4.56 per share, primarily as a result of adjusting our NexoBrid model for the terms of the licensing deal. We have also lowered the value of the Neon asset due to its recent stock performance.

NexoBrid licence deal

In May, MediWound announced it has licensed the North American commercialisation rights of NexoBrid to Vericel, which manufactures and commercialises advanced cell therapies for the sports medicine and severe burn care markets. Vericel (Nasdaq: VCEL) markets an autologous cellularised scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults and a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns. Total net sales for both products were $90.9m in 2018.

The terms of the agreement are for a $17.5m upfront and a total of $132.5m in potential milestones including $7.5m upon FDA approval and $125m in sales-related milestones to be paid by Vericel to MediWound. The first sales milestone of $7.5m will be triggered at an annual net sales level in North America of $75m, a relatively high threshold as we model $91m in peak sales for the product in the United States. Royalties will range from single digits to low double digits (we are modelling 8–12% royalties), which we view as relatively low for a product with positive Phase III data. The company also entered into a supply agreement with MediWound where Vericel will pay MediWound to manufacture NexoBrid on a cost plus fixed percentage basis. In addition, as BARDA has committed to procure NexoBrid (pending FDA authorisation), Vericel will pay a percentage of gross profits on initial committed amounts and a royalty on any additional BARDA purchases of NexoBrid beyond the initial committed amount.

With regards to BARDA, in late May, the organisation upsized its awarded contract with MediWound by $21m to initiate a NexoBrid expanded access treatment protocol (NEXT) in burn patients. Total non-dilutive funding from BARDA can now total up to $196m (with $31m provided so far) and has several components. BARDA is providing technical assistance and a total amount of $77m (which includes the $21m that was just announced) in funding for NexoBrid development activities towards FDA approval. BARDA also maintains $16.5m for the procurement of NexoBrid contingent on FDA emergency use authorisation and/or FDA marketing authorisation, a $10m option to fund development of other potential NexoBrid indications and an option to fund up to $50m for additional NexoBrid procurement. BARDA is also supporting the development of NexoBrid as a debridement product to treat sulfur mustard injuries, providing $12m in funding to support research and development activities up to pivotal studies in animals with options for additional funding of up to $31m for additional development activities through BLA submission to the FDA.

As a reminder, on 22 January 2019, MediWound announced positive top-line results from its US NexoBrid Phase III (DETECT) trial at 44 burn centres. 175 patients with deep partial thickness (DPT) and full thickness (FT) thermal burns were randomised to receive either NexoBrid, SOC or gel vehicle (placebo) at a ratio of 3:3:1, respectively. The study achieved the primary endpoint, which was incidence of complete debridement, with statistical significance, as well as several secondary endpoints (Exhibit 1). Additionally, the trial reached its safety endpoint with statistical significance, which was non-inferior time to complete wound closure with NexoBrid versus SOC.

Exhibit 1: Phase III DETECT study results

NexoBrid

Placebo

SOC

p-value

Primary endpoint

Incidence of complete debridement

93% (70/75)

4% (1/25)

N/A

P<0.0001

Secondary endpoints

Incidence of surgical eschar removal

4% (3/75)

N/A

72% (54/75)

P<0.0001

Time to achieve complete eschar removal (median)

1.0 days

N/A

3.8 days

P<0.0001

Blood loss (mean volume)

14.2ml

N/A

814.5ml

P<0.0001

Safety endpoint

Non-inferiority in time to complete wound closure

N/A

P=0.0003

Source: MediWound

MediWound plans to have a pre-BLA meeting with the FDA to request submission of the BLA based on these acute primary, secondary and safety data and then further supplement the application with 12-month follow-up data during FDA review. If the meeting goes according to plan, the company expects to file a BLA in Q419, which would imply an approval in H220. However, if the FDA does not permit BLA submission with only acute data, the company expects its timelines to be delayed by about three to four quarters (to allow the firm to collect and submit 12-month data).

Also, MediWound reported Q119 results. Revenues, which are based on NexoBrid sales in the EU, were $0.5m, down 11% from Q118. The company is working on accelerating these sales and we expect it to announce a plan around the next earnings call. The company reported a post-tax loss of $4.1m in Q119, which is down 10% from the same quarter a year ago. As of 31 March 2019, the company had $21.5m in cash (including equivalents and short-term deposits) which subsequent to quarter-end was increased by the $17.5m upfront from the licensing agreement. According to the company, it plans to concentrate these resources on progressing the EscharEx development programme while NexoBrid becomes a self-funded product via BARDA backing.

Gamida Cell Phase III to complete enrolment in H219

Gamida Cell’s 120-patient Phase III study of omidubicel (formerly NiCord) in patients with haematological malignancies is ongoing. Omidubicel, which is the company’s lead asset, expands umbilical cord blood (UCB) cell graft ex vivo and enriches the specific subpopulation of stem and progenitor cells to treat haematological malignancies such as leukaemia and lymphoma. Essentially, CD133+ cells selected from a single unit of UCB are cultured for 21 days in nicotinamide resulting in a c 100-fold expansion of dose stem and progenitor cells, which are then cryopreserved until they are transplanted into the intended patients. This expansion is expected to provide a substantial advantage over a single UCB graft. The use of UCB for bone marrow transplantation (BMT) is limited by the minimal number of stem and progenitor cells. The omidubicel process seeks to provide a more viable alternative to BMT in cancer patients and only partial genetic matching is needed (ie a minimum requirement of four out of six human leukocyte antigen biomarkers). The registrational trial is investigating the ability of omidubicel to provide a graft with an ample number of cells that have fast and vigorous in vivo neutrophil- and platelet-producing potential to improve transplantation outcomes (as low cell dose is associated with delayed engraftment and poor outcomes). The primary endpoint for the trial is time to neutrophil engraftment following transplantation (on or before the 42nd day post-transplant) compared to a non-manipulated cord blood unit. Enrolment is on track for completion in H219 with top-line data expected in H120. Provided that these Phase III data are positive, Gamida Cell plans to submit a BLA filing for omidubicel for the treatment of haematological malignancies in H220.

As a reminder, in data from a Phase I/II trial from 36 evaluable patients with acute leukaemia, myelodysplastic syndrome (MDS) and lymphoid malignancies (most recently presented at the International Society for Cell and Gene Therapy [ISCT] 2019 Annual Meeting in May), omidubicel demonstrated a median time to neutrophil engraftment of 11.5 days and a median time to platelet engraftment of 34 days. According to case-matched data from the Center for International Blood and Marrow Transplant Research, standard UCB treatment results in a median time to neutrophil engraftment of 21 days and a median time to platelet engraftment of 46 days. These data indicate that omidubicel has the potential to be the graft of choice for patients without a matched donor.

The company ended Q119 with $50.3m in cash and has guided for $35–40m in cash outflow for operating activities over 2019, which should be able to fund the company until around when the Phase III data are expected in H120.

Cadent receives milestone from Novartis

Cadent (16% owned by CBI) announced in May that it had received a $15m milestone payment from Novartis as MIJ821 (CAD-9271) for treatment-resistant depression entered Phase II. Cadent and Novartis entered into a licence and collaboration agreement in 2015 to advance their subtype selective negative allosteric NR2B-containing N-Methyl-D-aspartate (NMDA) receptor modulators to treat depression. NMDA receptors are glutamate-gated ion channels and are critical to central nervous system development, the production of rhythms for breathing and locomotion, and underlying synaptic plasticity, cognition and memory.1 Hyperactivity or hypofunction of the NMDA receptor system, which is the primary receptor for all excitatory neurotransmission that exists as multiple subunits with distinct properties, contributes to nervous system disorder pathophysiology such as depression, schizophrenia, pain and chronic neurodegenerative diseases.2

  Blanke, M. L., & VanDongen, A. M. (2009). NCBI. Boca Raton, FL: CRC Press/ Taylor & Francis.

  Zhou, Q., & Sheng, M. (2013). NMDA receptors in nervous system diseases. Neuropharmacology, 74, 69-75.

Under the financial terms of the agreement with Novartis, Cadent received a $6m upfront payment and is entitled to receive up to a total of $180m for development milestones, up to a total of $200m for sales milestones and royalties of up to 10% of total annual sales.

Cadent also announced that it received orphan drug designation from the FDA for CAD-1883 in spinocerebellar ataxia. CAD-1883 is a positive allosteric modulator of calcium-sensitive potassium (SK) channels. CAD-1883 increases the sensitivity of SK channels, which play an essential role in regular cerebellar neuronal firing, with the intent to restore regularity and improve motor function for the potential treatment of spinocerebellar ataxia, an orphan genetic disorder characterised by cerebellum dysfunction or degeneration that causes difficulty coordinating movements, and essential tremor, a neurological disorder characterised by involuntary and rhythmic shaking, most commonly of the hands and forearms. It is estimated to affect 11,000 people in the US and an additional 15,500 people in the EU5 and Japan. The company intends to initiate two Phase II trials in essential tremor and spinocerebellar ataxia.

Updates from other investments

Sight Diagnostics (owned by CBI via its 50% stake in the Anatomy Fund), which is developing a point-of-care full complete blood count (CBC) system, announced in April that it had completed its pivotal trial. According to clinicaltrials.gov, the trial had 700 participants across five sites in Israel and the US.

Pi-Cardia (21% held by CBI through direct investment and its 50% stake in the Anatomy Fund) announced in May the successful completion of the first in-human study for its Leaflex Performer catheter. Leaflex is a low-profile catheter intended to treat aortic stenosis without replacing the valve and can be implanted in a procedure that takes less than 20 minutes. The study was in 16 transfermoral cases and demonstrated that the use of Leaflex was both safe and feasible. Hemodynamic improvement was reported to be significant and greater than previously reported with balloon valvuloplasty. The company announced it will be moving Leaflex forward in clinical development.

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. Positive Phase III results.

File a BLA in Q419.

Gamida Cell*

Cord stem cell transplant for haematologic diseases

12

1998

Omidubicel : enrolling Phase III for haematological malignancies and two ongoing Phase I/II trials;
GDA-201 (formerly: NAM NK): initiated Phase I.

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

Enrolment underway for a Phase III study of omidubicel and on track for completion in H219 with top-line results expected in H120 and BLA filing in H220.

Anchiano Therapeutics*

Inodiftagene vixteplasmid is a DNA plasmid for non-muscle invasive bladder cancer

19

2004

Initiated inodiftagene vixteplasmid pivotal trial (Codex) in Q418.

Inodiftagene vixteplasmid is a 4.5kb recombinant DNA plasmid containing H19 regulatory sequences that drive expression of the potent diphtheria toxin A and inhibit protein translation in malignant bladder cells. Monotherapy clinical studies demonstrated promising efficacy rates.

Interim analysis on the first 35 patients from the Codex trial is expected in Q419.

Initiate second (in combination with BCG) pivotal clinical trial in 2020.

Biokine

Cyclic peptide inhibitor of CXCR4 for AML and other malignancies

26

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.

Positive engraftment data from the lead-in period of Phase III GENESIS trial.

Top line Phase II readout of BL-8040 + Keytruda in Pancreatic cancer, H219. Survival results mid-2020.

Source: Clal Biotechnology Industries. Notes: *Material assets according to CBI. All key investments included in our rNPV; BCG= Bacillus Calmette-Guerin; SAA= severe aplastic anaemia.

Exhibit 3: CBI’s direct holdings

Investment

Technology

% held

Founded

Status

Advantages

Targets

eXIthera

Factor XIa inhibition to prevent thrombosis and stroke

45

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.

Phase II initiation in early 2020. In process of selecting an oral candidate.

Elicio (Formerly Vedantra)

Cancer and infectious disease immunotherapy

35

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 vaccines targeting mutant KRAS oncogenes for the treatment of pancreatic cancer expected in the clinic in 2020.

Neon

Personalised neoantigen therapeutics for cancer

4

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.

NEO-PV-01 and OPDIVO combination results expected July 2019; NEO-PV-01 and KEYTRUDA combination results expected Q320.

Cadent

Treatment of CNS disorders by targeting calcium-sensitive SK channels and NMDA receptor modulation

16

2010

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

Phase II: CD-1883 for spinocerebellar ataxia and essential tremor – trial ongoing

CAD-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 2019. Initiate additional Phase II trial in spinocerebellar ataxia.

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 Fund

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: CE mark, pivotal trial in US completed

Point-of-care full complete blood count system. Completed $28m financing.

OLO: 510k approval late-2019.

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.

GC-100 FDA approval H220

MinInvasive

Device for arthroscopic rotator cuff repair

1.6

2011

MicroPort was granted with exclusive rights to distribute device in China

Needle-based shoulder tendon repair device that eliminates the need for suture anchors. FDA cleared - initiated limited/soft launch in the US.

Strategic partner for the US market

Pi-Cardia*

Non-implant based technology for aortic valve stenosis

1.6

2009

Leaflex: First in-human study shows significant improvement in aortic valve function

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

Additional clinical data for Leaflex, early 2020.

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 Fund).

Valuation

We have decreased our valuation of CBI from NIS850m or NIS5.27 per share to NIS736m or NIS4.56 per share, primarily as a result of adjusting our NexoBrid model for the terms of the licensing deal (we had previously modelled as if it was going to market NexoBrid itself, and assumed an NPV neutral licensing deal). The upfront payment was of a decent size ($17.5m), but the $125m in sales milestones only start being paid out once sales hit $75m in North America (with a $7.5m payment), which leads us to believe few of those will be paid out as our peak annual sales estimate in the region is $91m. Also, we would have expected a larger royalty rate for a product with positive Phase III trial data. The company disclosed tiered royalties that range from single digits to low double digits and we model 8–12%. Our sales estimates for NexoBrid are unchanged.

We have also lowered the value of the Neon asset due to the recent stock performance as that valuation is based on the value of the publicly traded shares.

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: 8-12% EscharEx: 20%

171

35%

59.8

Gamida Cell

Leukemia (AML, ALL, CML, CLL)

Phase III

2020

437

50%

100%

477

12%

57.3

Biokine

AML

Phase II

2023

1,286

30%

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

48

26%

12.6

Anchiano Therapeutics

Bladder cancer

Phase II and Phase III ready

2022

530

30%

100%

169

19%

32.0

Neon

145

4%

5.1

Elicio

35%

9.1

ExlThera

45%

10.3

Cadent

16%

12.0

Anatomy portfolio ($m)

8.5

Portfolio total ($m)

207

Net debt, unconsolidated (as of 31 March 2019) ($m)

(3.4)

Overall valuation ($m)

203

Shekel/dollar conversion rate

3.6

Overall valuation in Shekels (NISm)

736

Shares outstanding (m)

161.2

Per share (NIS)

4.56

Source: Company reports, Edison Investment Research

Financials

Due to significant ownership stakes, CBI consolidates the financials of several of its investments (MediWound, CureTech and the Anatomy Fund) and, on this basis, it had NIS94.7m in cash, cash equivalents and bank deposits as of 31 March 2019. CBI’s cash position at the corporate level (excluding consolidation) was NIS13.3m at the end of the quarter, with NIS25.6m in debt attributed to loans from a controlling shareholder (due in 2025).

Total consolidated revenues of NIS1.8m in the quarter were primarily generated through the sales of MediWound’s NexoBrid in Europe, Israel and Argentina for the year, which is down roughly 21% from Q118. The company also reported NIS16.1m in revenue as a realised gain from the decrease in equity interest of associates during the quarter.

Total consolidated R&D spend was NIS4.7m for the quarter, down 38% compared to the same quarter last year. General and administrative costs, which include payroll and related expenses, management fees, and marketing and advertising expenses on a consolidated basis were NIS13.8m, down 21% compared to Q118.

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

Exhibit 6: Financial summary

NIS'000s

2015

2016

2017

2018

Year end 31 December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

55,759

30,484

73,635

85,318

Cost of Sales

(42,549)

(46,967)

(32,433)

(17,600)

Gross Profit

13,210

(16,483)

41,202

67,718

R&D expenses

(42,011)

(9,954)

(32,644)

(26,218)

SG&A expenses

(81,107)

(13,525)

(61,679)

(54,369)

EBITDA

 

 

(175,382)

(434,812)

(103,330)

(54,021)

Operating Profit (before amort. and except.)

 

(179,999)

(451,764)

(103,633)

(54,318)

Intangible Amortisation

0

0

0

0

Exceptionals

0

0

0

0

Operating Profit

(179,999)

(451,764)

(103,633)

(54,318)

Other

(35,553)

(11,850)

(31,078)

(36,546)

Net Interest

6,197

9,510

80,478

49,997

Profit Before Tax (norm)

 

 

(209,355)

(454,104)

(54,233)

(40,867)

Profit Before Tax (FRS 3)

 

 

(209,355)

(454,104)

(54,233)

(40,867)

Tax

14,023

60,104

31,795

12,001

Profit After Tax (norm)

(195,332)

(394,000)

(22,438)

(28,866)

Profit After Tax (FRS 3)

(195,332)

(394,000)

(22,438)

(28,866)

Average Number of Shares Outstanding (m)

135.8

136.2

149.4

158.5

EPS- normalised (NIS) (attributable to shareholders of the company)

(-0.87)

(-1.57)

(-0.19)

(-0.28)

EPS - normalised (NIS)

 

 

(143.87)

(289.34)

(15.02)

(18.21)

EPS - FRS 3 (NIS)

 

 

(1.44)

(2.89)

(0.15)

(0.18)

Dividend per share (NIS)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,225,127

927,359

849,112

876,968

Intangible Assets

1,035,753

741,543

626,342

641,062

Tangible Assets

17,077

16,536

14,854

7,786

Other

172,297

169,280

207,916

228,120

Current Assets

 

 

307,645

191,351

185,228

139,113

Stocks

6,691

3,248

6,539

6,307

Debtors

18,784

16,415

13,612

29,036

Cash

256,105

171,022

165,077

103,770

Other

26,065

666

0

0

Current Liabilities

 

 

(66,785)

(68,277)

(31,182)

(23,681)

Creditors

(14,782)

(8,507)

(7,975)

(10,567)

Short term borrowings

0

0

0

0

Short term leases

0

0

0

0

Other

(52,003)

(59,770)

(23,207)

(13,114)

Long Term Liabilities

 

 

(373,520)

(297,938)

(194,962)

(124,781)

Long term borrowings

0

0

0

0

Long term leases

0

0

0

0

Other long term liabilities

(373,520)

(297,938)

(194,962)

(124,781)

Net Assets

 

 

1,092,467

752,495

808,196

867,619

CASH FLOW

Operating Cash Flow

 

 

(156,274)

(52,529)

(59,400)

(74,980)

Net Interest

23,298

0

0

0

Tax

(14,023)

(60,104)

(32,005)

(12,001)

Capex

0

0

0

0

Acquisitions/disposals

27,971

(395)

(3,876)

(47,298)

Financing

22,499

23,123

80,611

15,953

Dividends

0

0

0

0

Other

146,116

5,447

18,978

54,671

Net Cash Flow

49,587

(84,458)

4,308

(63,655)

Opening net debt/(cash)

 

 

(207,517)

(256,105)

(171,022)

(165,077)

HP finance leases initiated

0

0

0

0

Other

(999)

(625)

(10,253)

2,348

Closing net debt/(cash)

 

 

(256,105)

(171,022)

(165,077)

(103,770)

Source: Clal Biotechnology Industries reports

General disclaimer and copyright

This report has been commissioned by TASE and prepared and issued by Edison, in consideration of a fee payable by TASE. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, 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 securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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.

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd who holds an Australian Financial Services Licence (Number: 427484). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison 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. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Israel

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.

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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

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

General disclaimer and copyright

This report has been commissioned by TASE and prepared and issued by Edison, in consideration of a fee payable by TASE. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, 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 securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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.

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd who holds an Australian Financial Services Licence (Number: 427484). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison 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. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Israel

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.

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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

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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