Cantrixil to enter clinic in H216

Novogen 11 May 2016 ADR Update

Novogen

Cantrixil to enter clinic in H216

Clinical update

Pharma & biotech

 

11 May 2016

ADR research

 

Price

$2.09

Market cap

$36m

ADR/Ord conversion ratio 25/1

Net cash ($m) at 31 December 2015

28.6

ADRs in issue

17.2m

ADR Code

NVGN

ADR exchange

NASDAQ

Underlying exchange

ASX

Depository

BNY

ADR share price performance

52-week high/low

$6.55

$1.89

Business description

Novogen is an ASX- and NASDAQ-listed biotechnology company. Its two main drug technology platforms are super-benzopyrans (SBP) and anti-tropomyosins (ATM). SBP compounds show potent activity against cancer stem cells and are active across many different cancer types. ATMs show synergy with anti-mitotics and are active across many cancer types.

Next events

Complete Cantrixil toxicology studies

Q415

Initiate Cantrixil Phase I

H116

Initiate Anisina Phase I

H216

Analysts

Dennis Hulme

+61 (0)2 9258 1161

Christian Glennie

+44 (0)20 3077 5727

Novogen is a research client of Edison Investment Research Limited

Novogen has unwound its CanTx JV with Yale and resumed 100% ownership of its lead superbenzopyran Cantrixil, as it prepares to enter the clinic in ovarian cancer patients in Q416. Separately, its anti-tropomyosin (ATM) drug Anisina, which shows strong synergy with standard-of-care anti-mitotic drugs, is scheduled to enter the clinic in H216 or H117 (pending successful completion of toxicology studies). With $29m cash, we believe that Novogen is funded through FY18. Our valuation is virtually unchanged at $86m (vs $87m), with the benefit of resuming 100% ownership of Cantrixil offset by higher forecast G&A expenses.

Year end

Revenue (US$m)

PTP (US$m)

EPADR ($)

DPADR ($)

P/E (x)

Gross Yield (%)

06/14

0.3

(5.8)

(0.90)

0.0

N/A

N/A

06/15

1.2

(6.4)

(0.57)

0.0

N/A

N/A

06/16e

2.1

(9.6)

(0.56)

0.0

N/A

N/A

06/17e

3.7

(10.0)

(0.58)

0.0

N/A

N/A

Note: Converted at A$1/US$0.76 for the table above and throughout the note.

Cantrixil on track to enter clinic in Q416

Novogen expects to enroll the first patients in Q416 in a Phase I trial of intra-abdominal Cantrixil in ovarian cancer. It has appointed Quintiles as CRO to support execution of the study at centers in Australia and the US, and plans to submit an IND to the US FDA in August. A poster presenting the recently completed Cantrixil preclinical toxicology studies at AACR in mid-April concluded that “a dose should be tolerated in humans which is slightly higher than the efficacious dose for the three times weekly regimen in a mouse disseminated ovarian cancer model”.

Preclinical efficacy building for Anisina and Trilexium

Additional preclinical evidence presented to the Lorne Cancer Conference in February 2016 demonstrated the broad-based anti-tumor effect of pipeline drugs Anisina and Trilexium. We note that in a mouse model of prostate cancer Anisina enhanced the effect of docetaxel, a standard therapy for prostate cancer. This is further evidence that Anisina, which targets the tropomyosin component of the cell cytoskeleton, has the capacity to enhance the effect of microtubule-targeting cytotoxic drugs, including the taxanes (such as docetaxel) and vinca alkaloids.

Well-funded with cash runway to 2018

Novogen is well funded, with $28.6m cash at 31 December, which should be sufficient to fund operations through FY18. Moving its promising drugs into the clinic will be an important milestone and a potential re-rating catalyst.

Valuation: $86m or $4.97/ADR

Our risked DCF valuation is falls slightly to $86m or $4.97/ADR (undiluted, previously $87m and $5.13/ADR) and $4.35/ADR after diluting for options and convertible notes. The benefit of resuming 100% ownership of Cantrixil is offset by increased G&A expenses in response to the higher run rate in H116 (FY16 increased by $1.3m to $4.2m, with the increase flowing on to subsequent years).

Experienced pharma executive appointed as CEO

Dr James Garner commenced as CEO and MD of Novogen in February, replacing acting CEO Iain Ross. Dr Garner has extensive experience in drug development and commercialization with big pharma as well as smaller biotech companies. He was most recently head of the Unit Development Office, AP R&D with Sanofi, based in Singapore. He qualified in medicine at Imperial College, London and has worked with Biogen and Progen Pharmaceuticals in Australia, and for Quintiles and Takeda in Singapore.

Cantrixil: Preclinical tox studies complete, clinical trial Q416

Cantrixil is on track to commence first-in-man Phase I studies in Q4 CY16. Quintiles has been appointed as CRO to support execution of the trial, manufacture of the active ingredient has been completed, and formulation and stability testing of sterile GMP product for the Phase I clinical trial is expected to be completed in May.

Novogen presented the results of the recently completed preclinical GLP toxicology program on Cantrixil at the annual meeting of the American Association for Cancer Research (AACR) in April. The safety studies supported the proposed clinical used of Cantrixil using the intraperitoneal route of administration, concluding that “a dose should be tolerated in humans which is slightly higher than the efficacious dose for the three times weekly regimen in a mouse disseminated ovarian cancer model”. The major target organs for toxicity in rats and dogs were the gastrointestinal tract and male reproductive tract, which is not surprising in a drug that targets rapidly dividing cells.

Importantly, despite some preliminary signals in in vitro studies, ECG readings in a GLP-compliant electrophysiology study in dogs showed no effect of Cantrixil on QTc interval, indicating that the drug is not cardiotoxic in vivo.

The design of the Phase I study of Cantrixil to begin in Q416 has been amended to focus more specifically on patients with ovarian cancer, versus the previous plan for an all-comers trial in late-stage abdominal cancers patients with malignant ascites. The company plans to submit an Investigational New Drug (IND) application to the US FDA in August, and to recruit patients at sites in Australia and the US the IND is granted. The US FDA has granted Cantrixil Orphan Drug status for ovarian cancer.

Researchers at Yale University have shown that Cantrixil is active in a stringent, clinically relevant rodent model of human ovarian cancer. Cantrixil is the first drug to show uniformly high potency against the Yale library of ovarian cancer stem cells collected from tumors that had stopped responding to chemotherapy. Patients with ovarian cancer face a very poor prognosis, with a five-year survival rate of only 35%, so an urgent unmet clinical need remains for better treatment for ovarian cancer patients.

Cantrixil is designed to be used as an intra-peritoneal (IP) therapy delivered directly into the abdominal cavity. IP administration delivers higher concentration of the drug to the site of the tumor for longer periods, and studies of advanced ovarian cancer patients have shown a survival benefit for IP delivery compared to intravenous administration of chemotherapy drugs.

Novogen unwinds CanTx JV, resumes 100% control of Cantrixil

Up until now Cantrixil was developed by CanTx, which was established in November 2013 as a joint venture (JV) between Novogen (85%) and Yale University (15%). Novogen has disclosed that it has concluded funding to the JV and that the CanTx entity will be wound up, with all of the intellectual property licensed from Novogen to CanTx returned to Novogen. The JV has facilitated the investigation of Cantrixil in the laboratories of Professor Gil Mor, which has provided useful data to guide the development of the drug in ovarian cancer, as outlined above. Now that the decision has been made to move Cantrixil into clinical trials, Novogen has concluded that returning the licensed intellectual property to Novogen is the most effective way to move Cantrixil forward.

No details of the terms of the winding up of CanTx have been disclosed. In our valuation we assume Yale will receive compensation equivalent to 5% of the milestone and royalty revenue that Novogen receives for Cantrixil. This compares to Yale receiving a 15% share under the JV arrangement. This assumption may be revised if details of the unwinding are disclosed.

In addition, Novogen has cautioned that the unwinding of the CanTx JV may lead to the impairment of certain intercompany loans between Novogen and CanTx. We do not know the amount of the existing intercompany loans, but we note that the 2015 annual report refers to a maximum $1.5m funding commitment to CanTx. We assume that any impairment will be a non-cash item that does not affect our risk-adjusted DCF valuation.

Anisina

Anisina is a novel ATM therapy targeting the Tpm3.1 isoform of tropomyosin, which has a prominent role in cancer cells but a lesser role in normal cells. Previous preclinical studies have shown that Anisina synergistically enhances the killing effect of the widely used anti-microtubules class of chemotherapy drugs, which includes the taxanes (eg docetaxel and paclitaxel) and vinca alkaloids (eg vincristine). In some cases Novogen has shown a 20-30 fold increase in killing of cancer cells when Anisina was used in combination with microtubule targeting agents compared to either drug alone in preclinical studies.

Novogen presented additional preclinical evidence of the synergistic activity of Anisina in combination with an anti-microtubule drug at the Lorne Cancer Conference in Australia in February.

Exhibit 1 shows that Anisina at 100mg/kg and docetaxel at 3mg/kg were equally effective at inhibiting tumor growth when used as single agents. When the drugs were studied in combination they were used at half the dose used in the monotherapy arms of the study. Despite using a lower dose of each drug, the combination of Anisina and docetaxel more effectively inhibited tumor growth than either drug on its own, providing good evidence that the combination is synergistic in this model of prostate cancer.

Exhibit 1: Anisina/docetaxel combination reduced prostate tumor volumes in mice

Exhibit 2: Anisina was well tolerated and did not reduce animal weights

Source: Cooper et al poster, Lorne Cancer Conference. Note: Mean tumor volumes in mice bearing human DU145 prostate cancer tumors. Mice were treated with oral Anisina (ATM) daily, IV docetaxel (DTX) weekly, or half the concentration of ATM and DTX in combination. Day 66 tumor volume was significantly lower in the combination group than DTX alone (p<0.05).

Source: Cooper et al poster, Lorne Cancer Conference. Note: Median relative animal weights (fold change from day 1). Treatments as per Exhibit 1. At day 66 median relative weight was significantly higher in the Anisina group than docetaxel alone or vehicle control groups (p<0.05).

Exhibit 1: Anisina/docetaxel combination reduced prostate tumor volumes in mice

Source: Cooper et al poster, Lorne Cancer Conference. Note: Mean tumor volumes in mice bearing human DU145 prostate cancer tumors. Mice were treated with oral Anisina (ATM) daily, IV docetaxel (DTX) weekly, or half the concentration of ATM and DTX in combination. Day 66 tumor volume was significantly lower in the combination group than DTX alone (p<0.05).

Exhibit 2: Anisina was well tolerated and did not reduce animal weights

Source: Cooper et al poster, Lorne Cancer Conference. Note: Median relative animal weights (fold change from day 1). Treatments as per Exhibit 1. At day 66 median relative weight was significantly higher in the Anisina group than docetaxel alone or vehicle control groups (p<0.05).

Importantly, Anisina was well tolerated with no significant toxicity seen in any of the mice treated with Anisina. The low toxicity of Anisina is illustrated in Exhibit 2, which shows that mice treated with Anisina at 100mg/kg put on much more weight than those treated with docetaxel at 3mg/kg, although these two treatments were equally effective at inhibiting tumor growth. Mice treated with the lower dose of docetaxel in combination with Anisina put on significantly more weight than those treated with the higher dose of docetaxel alone, even though the combination treatment was more efficacious at reducing tumor growth. That is, the synergistic combination of Anisina plus docetaxel was both less toxic and more effective than a higher dose of docetaxel on its own. Anisina is a first-in-class drug with a novel method of action. If the synergy with the taxanes and/or vinca alkaloids seen to date in preclinical studies is confirmed in clinical trials, Anisina could potentially come to be used in a wide range of cancer types in combination with these drugs.

Anisina has already shown efficacy in animal models of prostate cancer, melanoma and neuroblastoma. We have included prostate cancer and melanoma as adult indications for Anisina and neuroblastoma as a pediatric indication in our valuation model.

Novogen anticipates taking Anisina through the clinic as an IV-delivered drug in combination with taxanes or vinca alkaloids. The Phase I trial is expected to be an all-comers trial in patients with late-stage, solid tumor cancers, which would likely include prostate cancer and melanoma. The choice of adult indication for subsequent trials will be influenced by the ongoing preclinical efficacy studies, as well as by which cancer types respond to therapy in Phase I trials. The company has confirmed that it intends to pursue a pediatric indication for Anisina in neuroblastoma.

Trilexium

Trilexium is at an earlier stage of development compared with Cantrixil and Anisina. The drug could potentially enter clinical trial in 2017 on completion of an ongoing program of drug formulation, preclinical efficacy and toxicology studies.

Trilexium has shown efficacy against cells from a wide range of cancers, including melanoma, colorectal, liver, lung, breast, prostate and brain cancers, in in vitro studies. Notably, the drug is highly cytotoxic against patient-derived explants of the childhood brain cancer known as Diffuse Intrinsic Pontine Glioma (DIPG) in in vitro studies. Trilexium also inhibits tumor growth in flank models where glioblastoma multiforme (GBM) tumors are growing under the skin of rodents.

Novogen presented additional data on Trilexium at the Lorne Cancer Conference. Trilexium inhibited tumor growth and extended survival as a monotherapy in mouse flank models of human prostate cancer and melanoma. In addition, combination therapy with Trilexium and the BRAF inhibitor dabrafenib (Tafinlar, GlaxoSmithKline) inhibited melanoma tumor growth and improved survival in mice to a significantly greater extent than dabrafenib alone (Exhibits 3, 4 and 5).

Exhibit 3: Trilexium inhibits tumor growth in two prostate cancer mouse models

Source: Ager et al poster, Lorne Cancer Conference. Note: Trilexium (TRXE-009-1) 80 mg/kg i.v. daily inhibited prostate tumor growth in two different mouse flank models (DU145 and PC3).

Exhibit 4: Trilexium inhibits tumor growth as monotherapy and in combination in mouse models of melanoma

Source: Ager et al poster, Lorne Cancer Conference. Note: Mean tumor volumes in mice bearing human melanoma tumors. Mice were treated with Trilexium (TRXE-009-1) 60 mg/kg i.v. daily, BRAF targeted therapy dabrafenib (30mg/kg daily), or a combination of the two drugs at the same concentration as monotherapy for 15 days. Tumors growth inhibition was significantly greater for the combination compared to either monotherapy.

Although Trilexium was effective at reducing tumor growth and improving survival in the mouse melanoma model, it was not as well tolerated as Anisina; mice in the Trilexium and combination treatment groups lost weight during the treatment period, then gained weight immediately on the cessation of treatment. This suggests that, in common with other cytotoxic drugs, Trilexium has toxic side effects, so selecting the appropriate dose that maximizes anticancer efficacy while minimizing side effects will be an important consideration during the drug development program.

Exhibit 5: Trilexium significantly improved survival in mouse melanoma model

Exhibit 6: Trilexium treated mice initially lost then recovered weight

Source: Ager et al poster, Lorne Cancer Conference. Note: Treatments as per Exhibit 4. Survival was significantly higher for the combination compared to either monotherapy. The monotherapy survival was significantly better than control.

Source: Ager et al poster, Lorne Cancer Conference. Note: Mice in the Trilexium and combination treatment groups initially lost weight over the treatment period, but gained weight immediately on cessation of treatment.

Exhibit 5: Trilexium significantly improved survival in mouse melanoma model

Source: Ager et al poster, Lorne Cancer Conference. Note: Treatments as per Exhibit 4. Survival was significantly higher for the combination compared to either monotherapy. The monotherapy survival was significantly better than control.

Exhibit 6: Trilexium treated mice initially lost then recovered weight

Source: Ager et al poster, Lorne Cancer Conference. Note: Mice in the Trilexium and combination treatment groups initially lost weight over the treatment period, but gained weight immediately on cessation of treatment.

Additional orthotropic animal studies are planned where the human tumor cells are growing in the same organ as the original cancer. This allows the cancer cells to interact with the surrounding organ tissue, which affects the growth, differentiation and drug sensitivity of tumor cells. Mechanism of action and biomarker studies are underway, aimed at informing patient selection for future clinical trials.

SBP patent granted, Anisina patent accepted

A patent for the SBP family has proceeded to grant in Australia, providing patent protection until 2035. The patent covers a wide range of new chemical entities, including Cantrixil and Trilexium, including composition of matter, a new abridged method of manufacture and treatment for a wide variety of cancer types.

In addition, the key patent application covering Anisina has been accepted by the Australian patent office and has now entered the standard opposition window prior to being granted.

The acceptance of these two patents by the Australian patent office confirms that the two drug classes are novel and inventive, and supports our view that the patents are likely to be granted in major markets, including in the US and Europe.

Valuation

Our valuation of Novogen has fallen slightly to $86m (previously $87m) or $4.97/ADR (undiluted, previously $5.13/ADR) and $4.35/ADR after diluting for options and convertible notes (vs $4.46/ADR), based on a risk-adjusted discounted cash flow model. Novogen’s primary listing is on the ASX under the code NRT; each NASDAQ-listed ADR represents 25 ordinary shares. Our undiluted valuation equals A$0.26 per ASX-listed ordinary share at current exchange rates.

The slightly lower valuation flowed from the benefit of resuming 100% ownership of Cantrixil being more than offset by higher forecast administration expenses. The terms of the CanTx JV winding up have not been disclosed, but we assume that Yale will receive compensation equivalent to 5% of the milestone and royalty revenue that Novogen receives for Cantrixil. This compares to Yale receiving a 15% share under the JV arrangement.

Our valuation reflects our understanding of the likely development path for Novogen’s three lead drugs Cantrixil, Anisina and Trilexium. Although we believe that our valuation model represents a likely development scenario, it should be considered as indicative because the choice of cancer indications that are eventually developed will be influenced by the ongoing preclinical efficacy studies, as well as by which patients show initial signs of efficacy in the pending Phase I trials.

Our cash flow forecasts extend out to 2035, but do not include any terminal valuation and apply a 12.5% discount rate. In calculating the diluted NPV/share, we assume that the $1.1m Triaxial convertible note is converted to 60m shares (the $1.1m convertible note was issued as part of the purchase of Triaxial and its SBP technology). The conversion of the notes is subject to achieving specified clinical milestones: 20m can be converted on IND allowance; 16m on completion of Phase I trials; and 24m on completion of Phase II trials.

Exhibit 7 shows our market assumptions for Cantrixil, Trilexium and Anisina and the contribution of product royalties and milestone payments to the rNPV. We have offset the risk-adjusted trial cost against milestone revenue for each drug, rather than against royalty revenue. This understates the contribution of the milestone payments to the rNPV and overstates the contribution of royalties.

We have explored the potential valuation uplift if each of the three drugs successfully completes preclinical development and progresses to a Phase I trial with a 15% likelihood of approval. In this scenario the overall NPV would increase by 85% to $156m ($9.12 per ADR, undiluted) from $86m under our base case.

Exhibit 7: Novogen sum-of-the-parts DCF

 

Base case likelihood (%)

rNPV ($m)

rNPV/ ADR ($)

Assumptions

Ovarian and other abdominal cancers: Cantrixil

7.5%

16.8

0.98

Global peak sales* of $680m from ovarian cancer (14,300 US deaths/yr, 30% penetration) and bowel cancer (50,300 US deaths, 25% develop malignant ascites, 20% penetration); pricing of $50k. Global sales 2x US sales; launch 2024; assume receives 15% royalty on net sales, pays away 5% of revenue to Yale.

Prostate cancer: Anisina

7.5%

20.1

1.17

Global peak sales of $880m assuming 29,500 US deaths/yr; 30% penetration; pricing of $50k. Global sales 2x US sales; launch 2025; assume receives 13% net royalty.

Melanoma: Anisina

7.5%

6.3

0.37

Global peak sales of $$300m assuming 9,700 US deaths/yr; 30% penetration; pricing of $50k. Global sales 2x US sales; launch 2025; assume receives 13% net royalty.

Pediatric neuroblastoma: Anisina

7.5%

0.5

0.03

Global peak sales of $25m assuming annual US incidence of 700 cases, 45% moderate to high risk, 80% penetration; pricing of $50k. Global sales 2x US sales; launch 2025; 13% net royalty on sales.

Melanoma: Trilexium

5.0%

4.1

0.24

Global peak sales of $$300m assuming 9,700 US deaths/yr; 30% penetration; pricing of $50k. Global sales 2x US sales; launch 2026; assume receives 15% royalty on net sales.

Brain cancer: Trilexium

5.0%

3.8

0.22

Global peak sales of $300m assuming annual US incidence of GBM of 11,500 cases, 25% penetration; DIPG US incidence 275, 80% penetration; pricing of $50k. Global sales 2x US sales; DIPG launch 2026; 15% royalty on net sales.

Cantrixil milestones

7.2

0.42

Assumes potential licensing upfronts and milestones total $140m ($23m after risk adjustment); assume 5% of upfront and milestone payment paid away to Yale.

Anisina milestones

6.0

0.35

Assumes potential licensing upfronts and milestones total $140m ($23m risk adjusted).

Trilexium milestones

2.9

0.17

Assumes potential licensing upfronts and milestones total $140m ($14m risk adjusted).

SG&A to 2020

(10.9)

(0.64)

Portfolio total

 

56.9

3.31

Cash (31 December 2015)

28.6

1.66

Enterprise total

 

85.5

4.97

Source: Edison Investment Research. Note: *Peak sales in 2015 dollars based on current addressable market. Actual peak sales forecast is higher due to market growth. We assume that the addressable markets grow at 5% per year.

Sensitivities

Our valuation includes revenues from the development of three drugs in five disease indications, as well as (risk-adjusted) upfront and milestone payments for three licensing deals. While each of these targeted indications is supported by the current preclinical efficacy studies, the company may not ultimately pursue development of the drugs for all of these indications. On the other hand, ongoing preclinical efficacy studies could identify additional disease indications that should be investigated in clinical trials. While we believe that the drug development timelines used in our forecasts are achievable, at this early stage it is hard to accurately predict how long it will take to get the drugs to market.

Financials: Funded for three years of operations

H116 results (ended 31 December) showed a net loss of $2.9m, 57% larger than the previous corresponding period (pcp). R&D expense was $3.8m compared to $1.6m in H115, reflecting the ramp-up of R&D activities, including preparations for the planned Cantrixil clinical trial. Administration expenses were $2.4m vs $1.1m pcp. We have updated our financial forecasts post the H116 results to reflect the higher administration expenses run rate, increasing forecast administration expenses by 44% for FY16 onwards

Cash at 31 December was $28.6m. We estimate that Novogen has sufficient funds to support operations to the end of FY18 if all three of Cantrixil, Trilexium and Anisina progress to clinical trials. Note that we include unrisked clinical trial costs in our financial forecasts to show the potential funding requirement if the clinical trial program is conducted in line with our expectations (trial costs risk-adjusted for NPV calculation).

Exhibit 8: Financial summary

 

US$000s

2013

2014

2015e

2016e

2017e

2018e

Year end 30 June

AASB

AASB

AASB

AASB

AASB

AASB

PROFIT & LOSS

Sales, royalties, milestones

811

0

0

0

0

0

Other (includes R&D tax rebate)

470

260

1,244

2,128

3,724

3,488

Revenue

 

 

1,281

260

1,244

2,128

3,724

3,488

R&D expenses

(195)

(1,882)

(4,511)

(8,360)

(9,880)

(12,160)

SG&A expenses

(1,922)

(2,808)

(2,484)

(4,213)

(4,437)

(4,671)

Other

0

0

0

0

0

0

EBITDA

 

 

(835)

(4,430)

(5,751)

(10,445)

(10,593)

(13,343)

Operating Profit (before GW and except.)

 

 

(1,387)

(4,021)

(4,906)

(10,458)

(10,610)

(13,362)

Intangible Amortization

(243)

(433)

(433)

(106)

(95)

(86)

Exceptionals

1,100

0

0

0

0

0

Operating Profit

(530)

(4,454)

(5,340)

(10,564)

(10,705)

(13,448)

Net Interest

(66)

(477)

(213)

1,012

728

431

Profit Before Tax (norm)

 

 

(1,146)

(5,752)

(6,401)

(9,552)

(9,977)

(13,017)

Profit Before Tax (reported)

 

 

(596)

(5,752)

(5,553)

(9,552)

(9,977)

(13,017)

Tax benefit

0

0

0

0

0

0

Profit After Tax (norm)

(1,146)

(5,752)

(6,401)

(9,552)

(9,977)

(13,017)

Profit After Tax (reported)

(596)

(5,752)

(5,553)

(9,552)

(9,977)

(13,017)

Average Number of Shares Outstanding (m)

114.7

156.7

238.4

426.4

429.7

429.7

Average Number of ADRs Outstanding (m)

4.6

6.3

9.5

17.1

17.2

17.2

EPS - normalized (c)

 

 

(0.68)

(3.62)

(2.28)

(2.24)

(2.32)

(3.03)

EPS - diluted

 

 

(0.68)

(3.62)

(2.28)

(2.24)

(2.32)

(3.03)

Dividend per share (c)

0.0

0.0

0.0

0.0

0.0

0.0

Earnings per ADR - normalized (c)

(17.1)

(90.4)

(56.9)

(56.0)

(58.0)

(75.7)

Earnings per ADR - diluted (c)

(17.1)

(90.4)

(56.9)

(56.0)

(58.0)

(75.7)

Dividend per ADR (c)

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,976

1,536

1,133

1,045

964

889

Intangible Assets

1,923

1,490

1,056

951

856

770

Tangible Assets

9

10

65

82

96

107

Investments

45

36

12

12

12

12

Current Assets

 

 

2,392

2,005

33,933

24,469

14,573

1,631

Stocks

0

0

0

0

0

0

Debtors

311

50

114

114

114

114

Cash

2,081

1,902

33,722

24,258

14,362

1,420

Other

0

53

96

96

96

96

Current Liabilities

 

 

(1,298)

(2,468)

(1,351)

(1,351)

(1,351)

(1,351)

Creditors

(201)

(197)

(1,230)

(1,230)

(1,230)

(1,230)

Short term borrowings

(1,076)

(2,057)

0

0

0

0

Other

(21)

(214)

(121)

(121)

(121)

(121)

Long Term Liabilities

 

 

0

0

0

0

0

0

Long term borrowings

0

0

0

0

0

0

Other long term liabilities

0

0

0

0

0

0

Net Assets

 

 

3,071

1,073

33,715

24,163

14,186

1,169

CASH FLOW

Operating Cash Flow

 

 

(6,683)

(4,339)

(4,377)

(10,445)

(10,593)

(13,343)

Net Interest

0

0

0

1,012

728

431

Tax

0

0

0

0

0

0

Capex

(8)

(21)

(74)

(30)

(30)

(30)

Acquisitions/disposals

138

0

6

0

0

0

Equity Financing

2,290

2,123

36,035

0

0

0

Dividends

0

0

0

0

0

0

Other

0

0

0

0

0

0

Net Cash Flow

(4,263)

(2,237)

31,590

(9,464)

(9,896)

(12,942)

Opening net debt/(cash)

 

 

(6,344)

(1,005)

156

(33,722)

(24,258)

(14,362)

HP finance leases initiated

0

0

0

0

0

0

Other

(1,076)

1,076

2,288

0

0

0

Closing net debt/(cash)

 

 

(1,005)

156

(33,722)

(24,258)

(14,362)

(1,420)

Source: Novogen accounts, Edison Investment Research. Note: Solely for the convenience of the reader the financial summary table has been converted at a rate of US$0.76 to A$1. Novogen reports statutory accounts in Australian dollars. These translations should not be considered representations that any such amounts have been or could be converted into US dollars at the assumed conversion rate.

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. Edison is authorised and regulated by the Financial Conduct Authority (www.fsa.gov.uk/register/firmBasicDetails.do?sid=181584). 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 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Novogen 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 Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. 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 2016. “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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Share this with friends and colleagues