Two new cannabinoid programs

Therapix Biosciences 17 November 2017 Update
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Therapix Bioscience

Two new cannabinoid programs

Earnings update

Pharma & biotech

17 November 2017

Price

US$4.84

Market cap

US$17m

NIS3.49/US$

Net cash ($m) at 30 September 2017

10.7

ADSs in issue

3.5m

Free float

30%

Code

TRPX

Primary exchange

TASE

Secondary exchange

NASDAQ

Share price performance

%

1m

3m

12m

Abs

(12.8)

(10.2)

(39.7)

Rel (local)

(13.7)

(14.3)

(49.2)

52-week high/low

US$10.1

US$4.5

Business description

Therapix Biosciences is an Israeli pharmaceutical company developing cannabinoids for several distinct indications. It is in currently in Phase IIa for Tourette syndrome, entering Phase I for mild cognitive impairment, has initiated Phase IIa for obstructive sleep apnea (OSA), and is beginning preclinical development for infectious diseases and pain.

Next events

THX-TS01 Phase IIa complete

H118

THX-ULD01 Phase I initiation

Q118

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Therapix Biosciences is a research client of Edison Investment Research Limited

Therapix is expanding its cannabinoid-based clinical pipeline beyond neurological disorders to potentially treat obstructive sleep apnea (OSA), a chronic sleep disorder. The company is investigating the efficacy of THX-OSA01, an oral THC/PEA formulation, for the treatment of OSA in a 30-patient Phase IIa trial. In addition, Therapix is exploring the potential of a cannabinoid composition containing an antibacterial agent for the treatment of infectious diseases in preclinical trials. The company reported that the Phase IIa Tourette’s study will read out in H118 and the Phase I for mild cognitive impairment will begin in Q118.

Year end

Revenue ($m)

PBT*
($m)

EPADS*
($)

DPADS
($)

P/E
(x)

Yield
(%)

12/16

0.0

(1.7)

(1.80)

0.0

N/A

N/A

12/17e

0.0

(4.3)

(1.18)

0.0

N/A

N/A

12/18e

0.0

(7.7)

(2.00)

0.0

N/A

N/A

12/19e

0.0

(12.8)

(3.16)

0.0

N/A

N/A

Note: *PBT and EPADS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.

THX-OSA01: A potential pharmacologic for OSA

Partnered with the Assuta Medical Center in Israel, the Phase IIa program is evaluating the efficacy of THX-OSA01 in 30 patients with confirmed OSA for one month. The primary efficacy endpoint is a significant decrease in the Apnea-Hypopnea Index (AHI), a metric for diagnosing and measuring OSA severity that represents the average number of breathing disturbances per one hour of sleep.

OSA is an unmet medical need

An estimated 5.9 million US adults are diagnosed with OSA and currently there are no pharmacotherapies available for treatment. Primary treatment includes positive airway pressure (PAP) devices, oral appliances, and surgery. However, inadequate compliance and efficacy rates have been reported. There is a significant need for therapeutic agents to reduce morbidity associated with OSA such as daytime fatigue, morning headaches, loud snoring and respiratory related arousals.

THX-150: A cannabinoid antibacterial program

The antibacterial properties of THC and other common cannabinoids have been investigated since the 1970s. Therapix is investigating the potential efficacy of THX-150, a drug candidate composed of THC, PEA and an antibacterial agent for the treatment of infectious diseases in a preclinical program in collaboration with the Weizmann Institute of Science and the Tel Aviv Sourasky Medical Center.

Valuation: Increased to $82.7m or $23.66 per ADS

We have increased our valuation to $82.7m or $23.66 per ADS, from $41.9m or $11.98 per ADS. This change was largely driven by the addition of THX-OSA01 to our model and rolling forward our NPVs, but was mitigated by a lower cash balance. We expect the OSA program to launch in 2022 and achieve peak sales of $754m. Our expected financing requirement for 2018 is $12m with a further $15m to reach profitability in 2021.

THX-OSA01 for obstructive sleep apnea

Therapix is currently developing THX-OSA01 for the treatment of obstructive sleep apnea (OSA). THX-OSA01 combines tetrahydrocannabinol (THC), the active constituent of cannabis, and palmitoylethanolamide (PEA), a generally regarded as safe (GRAS) lipid with cannabinoid properties. The company recently initiated a Phase IIa program to evaluate the efficacy of THX-OSA01 in 30 patients with confirmed OSA. The primary efficacy endpoint is a significant decrease in AHI after treatment.

OSA is a chronic sleep disorder characterized by recurring episodes of partial (hypopnea: decrease in air flow lasting 10 seconds or more with 30% oxygen reduction) or complete (apnea: cessation of air flow for 10 seconds or more) obstruction of airway passages during sleep causing respiratory-related arousals.1 OSA occurs when the throat muscles that support the soft palate, uvula, tonsils, side walls of the throat and tongue relax during sleep causing the airway to narrow or close. Signs and symptoms of OSA include daytime fatigue, difficulty concentrating, morning headaches, mood swings and depression, loud snoring, sudden arousals from sleep due to gasping or choking, and high blood pressure. Additionally, OSA is associated with several comorbidities including hypertension, congestive heart failure, obesity and diabetes.

Senaratna CV, et al. (2016), Prevalence of Obstructive Sleep Apnea in the general population: A systematic review, Sleep Medicine Reviews.

The gold standard diagnostic test for OSA is an overnight polysomnogram, or sleep study, which involves the simultaneous recording of physiologic signals including brain activity, muscle tissue activity, eye movement, breathing patterns and blood-oxygen levels. OSA severity is measured quantitatively using the Apnea-Hypopnea Index (AHI), or the average number of breathing disturbances per one hour of sleep in addition to average oxyhemoglobin desaturation and frequency of arousals from sleep. AHI scores of 0-4, 5-14, 15-30, and >30 correspond to normal, mild, moderate, and severe sleep apnea, respectively.

An estimated 5.9 million2 adults in the US are diagnosed with OSA while only 54%3 of those patients diagnosed are actively treated for the condition. Studies suggest that approximately 75%4 to 80%5 of severe cases remain undiagnosed, which leads to some variance in estimates of OSA disease prevalence. In addition, the prevalence of OSA is expected to rise along with the ageing population and obesity epidemic. Prevalence estimates from Europe, Australia and Asia are comparable to that of the US.6

Frost & Sullivan, (2016), American Academy of Sleep Medicine. Hidden health crisis costing America billions: underdiagnosing and undertreating obstructive sleep apnea draining health care system.

Russell, J. O., Gales, J., Bae, C., & Kominsky, A. (2015). Referral Patterns and Positive Airway Pressure Adherence upon Diagnosis of Obstructive Sleep Apnea. Otolaryngology-Head and Neck Surgery, 153(5), 881-887.

Maurer, J.T., (2008). Early Diagnosis of sleep related breathing disorders. GMS Curr Top Otorhinolaryngol Head Neck Surg.

Frost & Sullivan, (2016).

Punjabi, N. M. (2008). The Epidemiology of Adult Obstructive Sleep Apnea. Proceedings of the American Thoracic Society, 5(2), 136-143.

Treatment options for OSA

Primary treatment options for OSA include positive airway pressure (PAP) devices, oral appliances, and surgery. PAP devices moderately blow pressurized air through the airway at a pressure high enough to keep the throat open and can be delivered through three modes including continuous (CPAP), bilevel (BPAP), and autotitrating (APAP).7 CPAP is the most effective therapy and has shown to improve quality of life; however, approximately 8.2% to 9.2% of newly diagnosed patients refuse CPAP therapy and compliance rates range from 67% to 96%.8 Oral appliances are recommended to those who are either unable to tolerate CPAP therapy or refuse it. According to the American Sleep Apnea Association, over 100 different devices are FDA approved for the treatment of snoring and OSA. The devices are designed to hold the lower jaw forward to keep the airway open and prevent the tongue and upper airway muscles from collapsing. Efficacy of oral appliance therapy is 52%.9 Surgical treatment includes a variety of upper airway reconstructive or bypass procedures such as a tonsillectomy and/or adenoidectomy, tongue reduction or stabilization, nasal valve surgery and tracheotomy.10 Adjunctive to first-line therapies, weight loss, positional therapy and supplemental oxygen are also recommended to relieve symptoms of OSA.

Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. (2010). Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults. Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine5(3), 263–276.

Abad, V., & Guilleminault, C. (2011). Pharmacological treatment of obstructive sleep apnea. Current Pharmaceutical Design, 17, 1418-1425.

Abad, V., & Guilleminault, C. (2011).

Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. (2010).

A number of pharmacotherapies have been investigated for OSA management. However, no pharmacologic agent has demonstrated comparable efficacy to PAP. This is a difficult indication to drug because of the multifaceted nature of the neurochemical control and neuromodulation of the central respiratory drive and upper airway motor output.11 Drugs used to supplement OSA treatment target the reduction or modification of OSA risk factors (nasal congestion, reduced estrogen/testosterone levels), underlying metabolic diseases (thyroid disease, obesity), daytime sleepiness, hypertension and lipid disorders.12 According to clinical guidelines for the management of OSA in adults, the use of several pharmacotherapies such as methylxanthine derivatives, selective serotonergic reuptake inhibitors (SSRIs), protriptyline and estrogen therapy are generally not recommended for treatment (Exhibit 1). Furthermore, short-acting nasal decongestant sprays do not improve OSA and are not recommended due to concerns with rebound nasal congestion brought about by chronic use. Adjunct topical nasal corticosteroids have been shown to decrease AHI in patients with OSA.13 There is significant opportunity in this space for a product that can effectively manipulate the respiratory control system to improve OSA.

Prasad, B.et al. (2013). Proof of concept trial of dronabinol in obstructive sleep apnea. Frontiers in Psychiatry.

Abad, V., & Guilleminault, C. (2011).

Abad, V., & Guilleminault, C. (2011).

Exhibit 1: Brief summary of ineffective pharmacologic treatment for OSA

Drug

Notes

Recommendation

Methylxanthine derivatives

Stimulate ventilation by blocking adenosine receptors. IV aminophylline and theophylline studies showed no significant change in AHI, worsening of sleep quality and efficiency.

No.

Opioid antagonists

Stimulate ventilation by blocking endorphins that inhibit respiration or stimulating the cortex. Naloxone study did not improve AHI, minimally reduced oxygen desaturation index, and decreased total sleep time.

No.

Doxapram

Stimulates chemoreceptors of carotid arteries to stimulate respiration. Doxapram study improved blood-oxygen desaturation, decreased apnea length, but did not decrease the frequency of apneas.

No.

Nicotinic agents

Nicotinic acetylcholine receptor modulates excitatory inputs to hypoglossal motor neurons (extrinsic and intrinsic muscles of the tongue) and increases diaphragm activity. Studies have shown reduced sleep efficiency, impaired sleep, and variable AHI reduction.

No.

Carbonic anhydrase inhibitor

Stimulates ventilation by inducing metabolic acidosis. Acetazolamide studies showed decreases in AHI, excessive daytime fatigue, and frequent side effects such as burning/tingling sensations, ringing in the ears, nausea, etc.

No.

Paroxetine

SSRI agent to regulate upper airway dilator muscles. Studies showed reduction in AHI during NREM sleep, but not during REM sleep. No improvement in daytime fatigue, morning headaches, depression, or concentration.

No.

Protriptyline

TCA to reduce apnea episodes and increase daytime alertness. Studies have shown mixed results. Two studies showed no AHI or blood-oxygen level improvement. Another study showed reduced AHI during NREM sleep, improved oxygen desaturation and anticholinergic side effects.

No.

Clonidine

Stimulates alpha-adrenoceptors, which reduces sympathetic outflow from the central nervous system, decreases peripheral resistance, renal vascular resistance, heart rate and blood pressure. Studies showed complete REM sleep suppression and reduced time spent in REM sleep. In studies with OSA patients undergoing surgery, an opioid sparing effect was found.

Not for primary treatment, potential for perioperative management.

Mirtazapine

Enhances central respiratory drive by the de-inhibition of the vagal nucleus solitary input. Studies have shown mirtazapine increases sleep continuity and reduces AHI. Side effects include weight gain and increased sedation effects.

No.

Physostigmine

Increases sympathetic autonomic activity. Study demonstrated reduction in AHI during REM sleep. More studies are needed.

Potential for REM-related OSA.

Estrogen and progesterone

Enhance respiratory chemo-sensitivity. Two studies using both estrogen and progesterone showed decreased AHI and shorter hypopneas. In another study, estrogen alone reduced AHI, and progesterone weakened the effects. A progesterone study did not show any AHI improvement. Several risks are associated with hormone replacement therapy including venous thromboembolism, ischemic stroke and breast cancer.

No.

Thyroid replacement

Hypothyroid treatment has ambiguous effects on OSA.

Adjuvant to CPAP.

Source: Adopted from Abad, V., & Guilleminault, C. (2011). Note: SSRI = selective serotonin reuptake inhibitor, NREM = Non-REM, TCA = tricyclic antidepressant.

THC as a vagal afferent modulator for OSA

Several studies have highlighted the role of endocannabinoids as a neuromodulator of cardio-respiratory functions as well as interactions with neurotransmitters related to sleep-wake behaviors. Comparable factors have been shown in animal studies demonstrating respiratory stability improvement with cannabinoid agonists.14 Increased activity of vagus nerves, peripheral components of respiratory control including respiratory frequency, reduces upper airway activation or openness and therefore may predispose an individual to OSA. The nodose ganglia of the vagus nerves contain receptors for neurochemicals that can modulate vagal afferent activity. Studies have shown that vagal afferent nerves are inhibited by the injection of dronabinol, a non-selective cannabinoid (CB) 1 and CB2 agonist, into the nodose ganglia and the attenuation of nerve activity causes an increase in upper airway activity.15

Prasad, B.et al. (2013).

Calik, M.W., & Carley, D.W. (2014) Cannabinoid type 1 and type 2 receptor antagonists prevent attenuation of serotonin-induced reflex apneas by dronabinol in sprague-dawley rats. PLoS ONE, 9(10).

Two small-scale, randomized controlled clinical studies have been performed by RespireRx Pharmaceuticals examining THC for the treatment of obstructive sleep apnea. The company licensed exclusive worldwide rights to develop and commercialize cannabinoids for the treatment of breathing-related sleep disorders from the University of Illinois at Chicago. The first study was a 21-day randomized, placebo controlled, dose escalation (2.5mg, 5mg, 10mg) Phase IIa trial of dronabinol (generic THC) in 22 patients with OSA and it showed a significant decrease (32%) in AHI (events/hour) compared to baseline. 2.5mg (p= 0.007) and 10mg (p=0.036) doses of dronabinol significantly reduced AHI scores compared to baseline. The second study examined 56 patients with moderate to severe OSA in placebo and dose escalation cohorts (2.5mg and 10mg of dronabinol per day at night) over six weeks. It reached similar results, showing significant improvement in AHI scores at 2.5mg (p<0.02) and 10mg (p<0.001) and overall patient satisfaction (10mg, p<0.02). THC caused mild side effects including dry mouth, fatigue, headache, increased appetite, dizziness and sleepiness. RespireRx’s dronabinol for OSA program is Phase III ready.

Unlike previous attempts at targeting OSA using THC, Therapix’s THX-OSA01 is a co-formulation of THC with PEA, a lipid amide present in food that shares significant structural similarity to endocannabinoids. PEA has been approved for use as a health supplement in some parts of Europe and Canada because small-scale clinical studies,16 as well as case studies,17 indicate some benefit for the treatment of chronic inflammation and chronic pain, as well as little to no side effects. The Phase IIa trial will investigate doses up to 10mg THC and 800mg PEA. According to the company, the trial will cost approximately $0.5m and it expects a readout by mid-2018. Therapix believes that the “entourage effect” will enable PEA to enhance the potency of THC and improve its formulation’s overall efficacy, although this is by no means guaranteed.

Gabrielsson L, et al. (2016) Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy. Brit. J. Clin. Pharm. 82, 932-942.

Keppel J M, et al. (2012) Therapeutic utility of palmitoylethanolamide in the treatment of neuropathic pain associated with various pathological conditions: a case series. J. Pain. Res. 5, 437–442.

In parallel, Therapix entered into a product development agreement with Cure Pharmaceutical, a US drug delivery company, to develop a THC/PEA formulation on Cure’s buccal multilayer oral thin film (OTF), called CureFilm, to determine the most effective drug delivery mechanism for the THC/PEA formulation in an effort to increase drug bioavailability and half-life as well as stimulate rapid onset. Cure is developing a combination of 2.5mg of THS with 200mg PEA on its OTF technology.

THX-150: Antibiotic activity of THC

Therapix is developing THX-150, a drug candidate composed of THC, PEA, and an antibacterial agent for the treatment of infectious diseases. In collaboration with the Weizmann Institute of Science and the Tel Aviv Sourasky Medical Center in Israel, the company is initiating a preclinical program to investigate the potential efficacy of THX-150. According to Dr Itamar Shalit, Professor of Pediatrics at Tel Aviv University, early preclinical trials of THX-150 (with gentamicin as the selected antibacterial agent) were more effective in eliminating resistant bacterial strains than antibiotic controls.

Studies dating back to 1975 have demonstrated the antibacterial properties of THC and other common cannabinoids.18 However, the action of THC on CB2, primarily expressed on cells of immune system, induces T cell and B cell apoptosis and therefore demonstrates immunosuppressive effects.19 Today, there are significant challenges facing the treatment of infections caused by multidrug-resistant (MDR) bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and drug-resistant mycobacterium tuberculosis XDR-TB. Antibiotic activity is often measured by the minimum inhibitory concentration (MIC) number, which is the lowest concentration (in µg/mL) of an antibiotic that inhibits the growth of a strain of bacteria. MIC is a measure of susceptibility and is used to determine which class of antibiotic will be most effective for a particular strain of bacteria. The antibiotic activity of THC compares positively to common antibiotics in several drug-resistant strains of Staphylococcus aureus (Exhibit 2) and demonstrates the potential for THC as an antibacterial agent.20 It is important to note that the reported data are preclinical and that further clinical trials are needed to support the use of THC for this indication.

Van Klingeren, B. & Ten Ham, M. (1975) Antibacterial activity of Δ9-tetrahydrocannabinol and cannabidiol. Antoine van Leeuwenhock 42: 9-12

Lombard, C., et al. (2007). CB2 cannabinoid receptor agonist, JWH-015, triggers apoptosis in immune cells: Potential role for CB2-selective ligands as immunosuppressive agents. Clinical Immunology, 122(3), 259-270.

Appendino, G., et al. (2008) Antibacterial cannabinoids from Cannabis sativa: A structure-activity study. Journal of Natural Products, 71(8), 1427-1430.

Exhibit 2: MIC values of THC and antibiotics toward strains of Staphylococcus aureus

Compound

SA-1199B

RN-4220

XU212

ATCC25923

EMRSA-15

EMRSA-16

THC

2

1

1

1

2

0.5

norfloxacin

32

1

4

1

0.5

128

erthromycin

0.25

64

128

0.25

128

128

tetracycline

0.25

0.25

128

0.25

0.125

0.125

oxacillin

0.25

0.25

128

0.125

32

128

Source: Adopted from Appendino, G., et al. (2008). Notes: MIC = minimum inhibitory concentration (µg/mL); SA-1199B = fluoroquinolone-resistant strain also characterized as an antibiotic efflux pump; RN-4220 = macrolide-resistant strain; XU212 = tetracycline-resistant strain; ATCC25923 = standard laboratory strain; EMRSA-15 and EMRSA-16 = epidemic MRSA strains occurring in UK hospitals.

THX-TS01 and THX-ULD01 program updates

Therapix announced with its Q317 financial report that the ongoing Phase IIa trial at Yale University examining THX-TS01 for Tourette’s is scheduled to complete enrolment by the end of November 2017 and a readout is expected in H118. Seventeen of the total of 18 patients have been enrolled in the study and there have been no reported safety issues to date, which is consistent with the known profile of cannabinoids. The company also provided an update on the planned placebo-controlled, Phase IIb 13-week trial, which will now be conducted as an investigator-sponsored trial at the Hannover Medical School in Germany, instead of in the US, as the company previously stated. Additionally, Therapix expects to submit the Investigational Medicinal Product Dossier for this trial by year-end 2017.

The company also provided updates regarding the mild cognitive impairment program, which remains focused on traumatic brain injury (TBI). Therapix completed the development of the sublingual ultra-low dose formulation (0.4mg of THC) and plans to initiate the Phase I pharmacokinetics (PK) study in Q118. Following the PK study, which will take approximately one month, the company will be initiating a proof-of-concept (POC) study enrolling patients in the acute phase of TBI, which are typically patients as they are admitted to the emergency room. The primary endpoint of the POC study is a measure of cognitive functions post injury.

Valuation

We have increased our valuation to $82.7m or $23.66 per ADS, from $41.9m or $11.98 per ADS. We have added the OSA program to our valuation and determined a risk-adjusted NPV of $40.8m for the program. This is based on a 5% probability of success, which is due to its early stage and lack of clarity on portfolio prioritization, although we will likely increase this as the trial progresses. We assume the target market will be approximately 1.7 million and 2.9 million patients in the US and in Europe, respectively, who are diagnosed with severe OSA and receive treatment for their symptoms. We assume a (WAC) pricing of $3,500 in the US and $2,500 in Europe. The pricing is approximately at parity with the cost of renting a CPAP machine ($250/month). We also assume 30% discounts on the gross price in both territories. COGS are predicted at 13%, which includes an 8% royalty due to Dekel for the THC/PEA combination technology. We forecast that the company will have exclusivity through the 2035 expiration of its patents.

Other changes to our valuation include lower net cash and advancing our NPVs to the current period. Additionally, the company is working to establish a pain program partnered with Yissum, the tech-transfer company of the Hebrew University of Jerusalem. This opioid-sparing program, which is scheduled to begin during Q417, will evaluate the use of synthetic cannabinoids in combination with opioids in a preclinical rat model to allow for reduced opioid doses without changing analgesic efficacy. We expect to update our valuation with the release of interim data from the THX-TS01 Phase IIa trial expected during H118 and also with the antibacterial program and opioid-sparing program if they enter the clinic, along with any further clarity as to which of these relatively early stage programs will be prioritized.

Exhibit 3: Valuation of Therapix

Development program

Region

Prob. of success

Launch year

Peak sales ($m)

Margin

rNPV ($m)

THX-TS01

US

10%

2021

177

55%

15.49

THX-TS01

Europe

10%

2021

120

55%

15.03

THX-TS01

Development costs

(2.48)

THX-ULD01

US

5%

2022

69

50%

2.80

THX-ULD01

Europe

5%

2022

106

57%

4.69

THX-ULD01

Development costs

(2.02)

THX-OSA01

US

5%

2022

347

55%

21.80

THX-OSA01

Europe

5%

2022

407

49%

21.37

THX-OSA01

Development costs

(1.75)

Unallocated costs

(2.92)

Total

 

 

 

 

 

$72.0

Net cash and equivalents (Q317) ($m)

$10.7

Total firm value ($m)

$82.7

Total ADS (m)

3.5

Value per ADS ($)

$23.66

Source: Edison Investment Research, Therapix reports

Financials

Therapix reported a loss of $1.03m for Q317 attributed to R&D ($0.34m) and SG&A ($0.77m) expenditure. The company expects the current cash balance of $10.7m will be sufficient to fund current operations into Q318. We have increased our SG&A estimates for 2017 and 2018 by around $0.2m each year, due to increased spending on business development. Also, we have increased our R&D estimates by $0.3m in 2017 and $0.6m in 2018 due mainly to the addition of the Phase IIa OSA program. We expect the company to spend a total of $4.4m, including R&D and SG&A, in 2017.

Exhibit 4: Financial summary

$'000s

2016

2017e

2018e

2019e

31-December

IFRS

IFRS

IFRS

IFRS

INCOME STATEMENT

Revenue

 

 

0

0

0

0

Cost of Sales

0

0

0

0

Gross Profit

0

0

0

0

R&D

739

1,413

5,082

10,110

SG&A

1,267

2,939

2,998

3,058

EBITDA

 

 

(1,675)

(3,993)

(7,721)

(12,809)

Normalized operating profit

 

 

(1,679)

(3,997)

(7,725)

(12,813)

Amortization of acquired intangibles

0

0

0

0

Exceptionals

7

0

0

0

Share-based payments

(327)

(355)

(355)

(355)

Reported operating profit

(1,999)

(4,352)

(8,080)

(13,168)

Net Interest

(6)

(349)

9

13

Joint ventures & associates (post tax)

0

0

0

0

Exceptionals

0

0

0

0

Profit Before Tax (norm)

 

 

(1,685)

(4,346)

(7,717)

(12,800)

Profit Before Tax (reported)

 

 

(2,005)

(4,701)

(8,072)

(13,155)

Reported tax

0

0

0

0

Profit After Tax (norm)

(1,685)

(4,346)

(7,717)

(12,800)

Profit After Tax (reported)

(2,005)

(4,701)

(8,072)

(13,155)

Minority interests

0

0

0

0

Discontinued operations

0

0

0

0

Net income (normalized)

(1,685)

(4,346)

(7,717)

(12,800)

Net income (reported)

(2,005)

(4,701)

(8,072)

(13,155)

Basic average number of ADS outstanding (m)

1

4

4

4

EPS - normalized (c)

 

 

(179.9)

(118.4)

(200.1)

(316.2)

EPADS - diluted normalized ($)

 

 

(1.80)

(1.18)

(2.00)

(3.16)

EPADS - basic reported ($)

 

 

(2.14)

(1.28)

(2.09)

(3.25)

DPADS (c)

0.00

0.00

0.00

0.00

BALANCE SHEET

Fixed Assets

 

 

441

31

31

31

Intangible Assets

0

0

0

0

Tangible Assets

11

31

31

31

Investments & other

430

0

0

0

Current Assets

 

 

804

9,996

14,896

2,937

Stocks

0

0

0

0

Debtors

117

188

0

0

Cash & cash equivalents

676

9,773

14,861

2,902

Other

11

35

35

35

Current Liabilities

 

 

(672)

(656)

(1,269)

(2,106)

Creditors

(672)

(656)

(1,269)

(2,106)

Tax and social security

0

0

0

0

Short term borrowings

0

0

0

0

Other

0

0

0

0

Long Term Liabilities

 

 

0

0

(12,000)

(12,000)

Long term borrowings

0

0

(12,000)

(12,000)

Other long term liabilities

0

0

0

0

Net Assets

 

 

573

9,371

1,658

(11,138)

Minority interests

0

0

0

0

Shareholders' equity

 

 

573

9,371

1,658

(11,138)

CASH FLOW

Op Cash Flow before WC and tax

(1,675)

(3,993)

(7,721)

(12,809)

Working capital

233

(87)

801

836

Exceptional & other

(38)

14

0

0

Tax

0

0

0

0

Net operating cash flow

 

 

(1,480)

(4,066)

(6,920)

(11,973)

Capex

(4)

(22)

0

0

Acquisitions/disposals

0

0

0

0

Net interest

0

0

9

13

Equity financing

913

12,900

0

0

Dividends

0

0

0

0

Other

(349)

(22)

0

0

Net Cash Flow

(920)

8,790

(6,912)

(11,960)

Opening net debt/(cash)

 

 

(1,596)

(676)

(9,773)

(2,861)

FX

0

307

0

0

Other non-cash movements

0

0

0

0

Closing net debt/(cash)

 

 

(676)

(9,773)

(2,861)

9,098

Source: Edison Investment Research, Therapix Biosciences 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. Edison 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 Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Therapix Bioscience and 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 Investments Pty Ltd (Corporate Authorised Representative (ACH 161 453 872) 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 2017. “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.

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United Kingdom

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US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

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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 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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. Edison 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 Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Therapix Bioscience and 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 Investments Pty Ltd (Corporate Authorised Representative (ACH 161 453 872) 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 2017. “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 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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