PharmaMar — Aplidin and Zepsyre milestones coming up

PharmaMar — Aplidin and Zepsyre milestones coming up

PharmaMar investors await two key events that are expected in the next few months. The European Committee for Medicinal Products for Human Use (CHMP) should announce a recommendation regarding Aplidin’s marketing application in the EU for refractory multiple myeloma in combination with dexamethasone by the end of the year. Also, Phase III results from the 443-patient CORAIL study studying Zepsyre® in platinum-resistant ovarian cancer patients is expected early next year.

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PharmaMar

Aplidin and Zepsyre milestones coming up

Financial update

Pharma & biotech

3 November 2017

Price

€3.24

Market cap

€720m

$1.17/€

Net debt (€m) at end September 2017

66.4

Shares in issue

222.2m

Free float

73%

Code

PHM

Primary exchange

BME

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

1.9

(14.7)

33.3

Rel (local)

(0.1)

(14.3)

13.1

52-week high/low

€4.2

€2.3

Business description

PharmaMar is a Spanish biopharmaceutical company with a core focus on the development of marine-based drugs for cancer. Yondelis is approved in the US, EU and Japan, and is partnered with Janssen (J&J) in the US and Taiho in Japan. The group also has consumer chemicals, molecular diagnostics and RNAi operations.

Next events

Aplidin CHMP decision

Q417

Zepsyre® ovarian Phase III results

Q118

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

PharmaMar is a research client of Edison Investment Research Limited

PharmaMar investors await two key events that are expected in the next few months. The European Committee for Medicinal Products for Human Use (CHMP) should announce a recommendation regarding Aplidin’s marketing application in the EU for refractory multiple myeloma in combination with dexamethasone by the end of the year. Also, Phase III results from the 443-patient CORAIL study studying Zepsyre® in platinum-resistant ovarian cancer patients is expected early next year.

Year
end

Sales revenue (€m)

PBT*
(€m)

EPS*
(c)

DPS
(c)

P/E
(x)

Yield
(%)

12/15

162.0

5.9

3.0

0.0

108.0

N/A

12/16

164.0

(24.7)

(10.8)

0.0

N/A

N/A

12/17e

171.2

(11.1)

(5.0)

0.0

N/A

N/A

12/18e

191.6

27.2

12.2

0.0

26.6

N/A

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

Aplidin CHMP recommendation by year-end

Aplidin (plitidepsin) is a first-in-class marine derived drug targeting eFF1A2, a proto-oncogene over-expressed in multiple myeloma. In the 255-patient Phase III ADMYRE trial, Aplidin was able to show a highly statistically significant (p=0.0062) progression-free survival (PFS) benefit, the primary endpoint of the trial. We expect Aplidin to reach global peak sales of US$300m, including US$115m in Europe.

Phase III CORAIL study is key

PharmaMar is studying Zepsyre (lurbinectedin) in multiple indications including ovarian, breast and small cell lung cancer (SCLC). The 443-patient CORAIL study in platinum-resistant ovarian cancer will be the first Phase III readout for the drug. PFS is the primary endpoint and in a previous Phase II trial comparing Zepsyre to Topotecan, the drug showed a statistically significant PFS benefit in platinum-resistant cancer patients (5.7 months versus 1.7 months, p=0.005) in the randomised-controlled stage of the trial.

SCLC data promising

PharmaMar recently presented promising data of Zepsyre in SCLC patients at the European Society for Medical Oncology (ESMO). In combination and monotherapy cohorts, the therapy had an overall response rate of 36-37%, higher than the 13-24% response rate historically seen with the current standard of care, Topotecan. The 600-patient Phase III ATLANTIS study in relapsed SCLC patients is ongoing.

Valuation: Increased to €1.84bn or €8.28 per share

We are increasing our valuation from €1.68bn or €7.56/share to €1.84bn or €8.28/share, mainly due to upgrading our estimates for the consumer chemicals business and rolling forward our NPV. We have also made relatively minor adjustments to Yondelis revenues and operating expenses. We will review our valuation further following the CHMP decision on Aplidin and the Zepsyre Phase III data in ovarian cancer.

Aplidin decision coming up

In September 2016, PharmaMar filed for approval to market Aplidin to treat relapsed/refractory multiple myeloma in Europe. A decision by the CHMP regarding Aplidin is expected by year-end. Aplidin has orphan drug designation in Europe and the US.

In March 2016, the company announced positive top-line results from the 255-patient ADMYRE Phase III trial of Aplidin plus dexamethasone versus dexamethasone alone in relapsed/refractory multiple myeloma. The trial met its primary endpoint, showing a statistically significant 35% reduction in the risk of disease progression or death. Additional data were recently released as part of the abstracts for the American Society of Hematology (ASH) 2017 Annual Meeting (Atlanta, 9-12 December 2017). According to the independent review committee (IRC), the median PFS was 2.6 months in the treatment arm compared to just 1.7 months in the control arm (HR=0.65, p=0.0062). Median PFS by investigator’s assessment was 3.8 months in the treatment arm and 1.9 months in the control arm (HR=0.611, p=0.0048). While the medians themselves differ, the hazard ratios and p-values are very similar, indicating that the data are largely consistent.

In this Phase III, patients in the control arm were able to cross over into the treatment arm following progression, confounding the overall survival results (the patients in the control arm were not true control patients as they also received therapy, although later when prognosis would likely be poorer). However, strong trends were still seen, although these were not statistically significant. Median overall survival was 11.6 months in the treatment arm versus 8.9 months in the control arm (HR=0.797, p=0.1273). Using an analysis that allows for the crossover, the overall survival data become significant with median overall survival of 11.6 months in the treatment arm versus 6.7 months in control (HR=0.667, p=0.0069).

Exhibit 1: Aplidin (plitidepsin) Phase III ADMYRE data

Arm A (treatment): plitidepsin 5mg/m2 D1 + D15 plus DXM 40mg, D1 + D8 + D15 + D22 (n=171)

Arm B (control): DXM 40mg, D1 + D8 + D15 + D22 (n=84)

p-value

Objective response rate (%)

13.8%

1.7%

N/A

Duration of response (months)

12.0

1.8

N/A

PFS according to IRC assessment (months)

2.6

1.7

0.0062

PFS according to investigator's assessment (months)

3.8

1.9

0.0048

Overall survival-unadjusted (months)

11.6

8.9

0.1273

Overall survival-adjusted for crossover (months)

11.6

6.7

0.0069

Source: ASH 2017 abstracts

Multiple myeloma accounts for 10% of all haematological malignancies. It is caused by malignant plasma cells that multiply very rapidly. According to the National Cancer Institute, 30,280 new cases are expected to be diagnosed in the US in 2017, with 12,590 dying of this disease. In Europe, the incidence is 4.5-6.0 out of every 100,000 people each year. We expect Aplidin to reach global peak sales of US$300m, including US$115m in Europe.

PharmaMar continues to recruit patients in multiple trials of Aplidin including a Phase II in combination with bortezomib and dexamethasone in double refractory multiple myeloma patients. It is continuing to recruit patients for a Phase I trial in the expansion phase of Aplidin in combination with bortezomib and dexamethasone in relapsed/refractory multiple myeloma following promising results that were presented at ASCO in 2016. It has also begun a new Phase I trial of Aplidin in combination with bortezomib, pomalidomide and dexamethasone in multiple myeloma patients exposed to proteasome inhibitors and refractory to lenalidomide.

PharmaMar has an Aplidin co-promotion agreement with Chugai Pharma Europe covering certain European countries (France, Germany, the UK, Benelux, Ireland and Austria). PharmaMar earned a €4m milestone from Chugai for filing the Marketing Authorisation Application to the European Medicines Agency.

PharmaMar has also licensed marketing rights to Specialised Therapeutics Australia covering Australia, New Zealand and certain Asian countries, and to TTY Biopharm in Taiwan. It retains commercialisation rights in several key European territories, including Spain, Italy and Northern Europe, where we assume it will market Aplidin using its existing salesforce. PharmaMar also retains production rights and will supply Aplidin to its partners for sale in the licensed regions. There is potential for further licensing newsflow with Aplidin as the regulatory dossier for European approval will also be valid for more than 40 additional ex-EU countries.

The Phase III CORAIL study

PharmaMar initiated its Phase III CORAIL study in June 2015. Patient recruitment was completed in October 2016 and data is expected by early 2018. It has enrolled 443 patients across 113 sites in North America and Europe. It is testing 3.2mg/m2 of Zepsyre given intravenously every three weeks compared to Topotecan given daily for five days every three weeks intravenously and pegylated liposomal doxorubicin (PLD) given once every four weeks intravenously. The primary endpoint is PFS. The study was designed to detect a hazard ratio (HR) of 0.7 with 90% power, though the company believes it can achieve statistical significance with an HR of 0.8.

PharmaMar ran an 81-patient, two-stage, controlled Phase II trial in platinum-resistant/refractory ovarian cancer patients. The first stage was exploratory and included 22 patients who received 7mg of Zepsyre every three weeks. The second stage compared the same dose of Zepsyre (30 patients) with either daily or weekly Topotecan regimens (29 patients). Across all patients and both stages, Zepsyre demonstrated a 23% response rate compared to 0% in patients receiving Topotecan (p=0.0033). Among those with platinum-resistant disease, the drug achieved a 30% response rate (those with refractory disease, who by definition are difficult to treat, had a 10.5% response rate).

Exhibit 2: Phase II data

ORR (%) –
all patients

ORR (%) – platinum-resistant

PFS (months) –
all patients

PFS (months) – platinum-resistant

Overall survival (months) –
all patients

Overall survival (months) – platinum-resistant

Zepsyre – both stages

23%

30%

4.0

5.0

10.6

13.5

Zepsyre – second stage

17%

24%

3.9

5.7

9.7

15.6

Topotecan – second stage

0%

0%

2.0

1.7

8.5

8.7

Source: PharmaMar, Poveda et al., Phase II randomized study of PM01183 versus topotecan in patients with platinum-resistant/refractory advanced ovarian cancer. Annals of Oncology. 2017 June; 28(6):1280-1287.
Note: The trial as a whole had 52 patients who received Zepsyre (30 in the second stage of the study) and 29 who received Topotecan. There were 17 platinum-resistant patients who received Zepsyre in the second stage and 16 who received Topotecan.

PFS, the primary endpoint of the upcoming CORAIL study, was a relatively modest 4.0 months in the 52 patients who received Zepsyre in both stages and was 3.9 months in the 30 patients receiving the drug in the second stage, though that compares favourably to the 2.0 months seen in the 29 patients who received Topotecan (p=0.0067). Also, the PFS in all patients who received Zepsyre was skewed by the platinum-refractory patients, who progressed relatively quickly (2.9 months in the first stage and 1.4 months in the second stage according to the original abstract1). Among platinum-resistant patients, PFS in those who received Zepsyre was 5.0 months for the trial as a whole and 5.7 months in the second stage of the trial, a significant improvement over the 1.7 months seen in patients receiving Topotecan (p=0.005).

  Poveda et al., Lurbinectedin (PM01183), an active compound in platinum-resistant/refractory ovarian cancer (PRROC) patients. Journal of Clinical Oncology 32, no. 15_supple (May 2014) 5505.

Exhibit 3: Platinum-resistant patient PFS data from the second stage of the Phase II

Source: PharmaMar, ASCO 2014

There were trends towards an overall survival benefit. Median overall survival was 10.6 months for all patients who received Zepsyre, 9.7 months for patients in the second stage vs 8.5 months for Topotecan patients (p=0.2871). Including only platinum-resistant patients, the median overall survival improves to 13.5 months for Zepsyre patients (15.6 months for those in the second stage vs 8.7 months for Topotecan patients). One caveat when trying to interpret the survival data is that 52% of the patients in the control arm crossed over to Zepsyre following disease progression, which could have affected the results in the control arm’s favour.

Exhibit 4: Platinum-resistant patient OS data from the second stage of the Phase II, as of ASCO 2014

Source: PharmaMar, ASCO 2014. Note: The survival data has since been updated so that median survival in the Zepsyre arm is currently reported as 15.6 months versus 8.7 months for Topotecan among patients in the second stage of the trial.

There are a few important changes in the design of the Phase III trial compared to the Phase II. First, the trial is focusing on platinum-resistant patients rather than both resistant and refractory. Second, the comparator arm is different as it now includes both Topotecan and PLD. Initially, the Phase II trial was supposed to have PLD as a comparator but due to a worldwide shortage at the time, it was switched to Topotecan. Additionally, in the Phase III, patients who receive Topotecan will only be receiving the standard, five-day regimen rather than the weekly regimen. In the Phase II, patients could receive both and 21 of the 29 Topotecan patients were on the weekly regimen. In a previous trial comparing the two Topotecan regimens in platinum-resistant ovarian cancer patients, there were trends favouring the five-day regimen in both response rate (15% vs 4%) and PFS (4.3 months vs 3.0 months), though neither difference was significant.2 This makes it likely that the control arm in the Phase III will have stronger results than in the Phase II (the company is assuming a PFS in the control arm of 3.5 months, higher than the Phase II results and comparable to historical data).

  Sehouli et al., Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer. Journal of Clinical Oncology 29, no. 2 (January 2011) 242-248.

Another key change is that the company amended the Zepsyre dosing regimen. It was a flat dose of 7mg given every three weeks in the Phase II, but is now based on body surface area. At a dose of 3.2mg/m2 and an average body surface area of around 1.7 for women with ovarian cancer,3 the average dose should be approximately 5.4mg, somewhat lower than the previous dose. The main reason for the change was the high level of neutropenia found in the Phase II (85% grade 3/4, 64% grade 4) especially in those with low body surface area. Neutropenia is a fairly common toxicity of chemotherapy (the rate of grade 4 neutropenia in the five-day Topotecan regimen was 88% in the Phase II) that increases the risk of infection. It can be managed with granulocyte-colony stimulating factor (G-CSF) as well as antibiotics.

  Sacco et al., The Average Body Surface Area of Adult Cancer Patients in the UK. PLoS One. 2010; 5(1): e8933

Based on pharmacokinetic (PK) modelling, the 3.2mg/m2 is expected to still be above the efficacy threshold (the PK profile in the Phase II indicated patients were well above the efficacy threshold at the 7mg flat dose) while lowering grade 4 neutropenia by at least 20%4 (it is expected to also reduce the incidence of grade 3/4 hematologic and biochemical abnormalities, gastrointestinal disorders and fatigue). However, we will not know for sure until we see the data and this change in dosing regimen between trials increases the risk that the results will not be statistically significant (though based on the Phase II data, there is a cushion).

  Fernandez-Teruel et al., Lurbinectedin (PM1183) efficacy in platinum resistant/refractory ovarian cancer (PRROC) patients correlates with drug exposure using pharmacokinetic/pharmacodynamic (PK/PD) modelling. International Journal of Gynecologic Cancer 2015; 25: 433 (Abs N_ ESGO-0843).

SCLC data at ESMO

PharmaMar recently presented promising updated data of Zepsyre in SCLC patients at the European Society for Medical Oncology (ESMO) in Madrid. The company had previously released data from Cohort A and combination data with paclitaxel (TAX). The new data includes Cohort B, which had a body surface area based dose of Zepsyre (2mg/m2) in combination with 40mg/m2 of doxorubicin (DOX), as well as a single agent arm with Zepsyre at a 3.2mg/m2 body surface area based dose. In both the new arms, the response rate is much higher than the response rate typically seen with Topotecan (13-24%5). Importantly, in Cohort B, which has the same dose as what is being used in the Phase III trial, PFS was 5.3 months, which is higher than the 3-4 months typically seen with Topotecan.

  Garst et al., Topotecan: An evolving option in the treatment of relapsed small cell lung cancer. Therapeutics and Clinical Risk Management 2007:3(6) 1087-1095.

Exhibit 5: Zepsyre in SCLC

Lurbinectedin + DOX (q3wk)

Lurbinectedin + TAX (q3wk)

Lurbinectedin single agent (q3wk)

Cohort A L 3-5mg FD D1 + DOX 50mg/m2 D1 (n=21)

Cohort B L 2mg/m2 D1 + DOX 40mg/m2 D1 (n=27)

L 2.2mg/m2 D1 + TAX 80mg/m2 D1 & D8 (n=7)

L 3.2mg/m2 D1
(n=36)

Complete response rate (%)

10%

4%

14%

0%

Partial response rate (%)

57%

33%

57%

36%

Objective response rate (%)

67%

37%

71%

36%

Stable disease (%)

14%

33%

0%

39%

Progressive disease (%)

19%

30%

29%

25%

Disease control rate (%)

81%

70%

71%

75%

Duration of response (months)

4.5

5.2

2.3

6.2+

Progression free survival (months) - patients with chemotherapy free interval of >30 days

4.7

5.3

3.9

3.1+

Progression free survival (months) - platinum sensitive patients

5.8

6.2

3.9

4.6+

Source: PharmaMar, ESMO 2017. Note: L = lurbinectedin, DOX = doxorubicin, TAX = paclitaxel.

In August 2016, PharmaMar initiated the ATLANTIS trial, which is a multicentre, open-label, randomised Phase III trial in 600 patients with relapsed (second-line) SCLC following platinum-containing therapy. The primary endpoint is progression free survival (PFS) comparing patients treated with the combination of Zepsyre and doxorubicin to the control arm where patients are treated with either Topotecan or the CAV regimen, a combination of cyclophosphamide, adriamycin (the brand name for doxorubicin) and vincristine. Data from the ATLANTIS trial is expected in 2019.

PM14

PharmaMar has also announced that it has enrolled the first patient into a new development program for the PM14 molecule. The trial is expected to enrol approximately 50 patients with advanced solid tumours. We will include PM14 in our valuation once we receive more information on the program, such as data and focus.

Valuation

We are increasing our valuation from €1.68bn or €7.56/share to €1.84bn or €8.28/share, mainly due to upgrading our estimates for the consumer chemicals business (owing to higher expectations for revenues and lower expectations for expenses which has a magnified impact on profit) and rolling forward our NPV (which had an especially high impact on our value for Zepsyre as it is a pipeline product with meaningful sales in later years). We have also made relatively minor adjustments to Yondelis revenues and operating expenses. We will review our valuation further following the CHMP decision on Aplidin and the Zepsyre Phase III data in ovarian cancer.

Exhibit 6: PharmaMar sum-of-the-parts DCF

Product

rNPV (€m)

rNPV/

share (€)

Assumptions

Chemicals business FCF

131.2

0.59

7.5% WACC, 3% growth rate from 2019 onwards, accounts for 45% of group capex.

Yondelis (Europe)

578.6

2.60

Second-line soft-tissue sarcoma (STS) peak sales of €87m with 40% penetration; third-line ovarian cancer peak sales of €37m with 8% penetration into addressable platinum sensitive market. First potential generics in 2024. 10% WACC.

Yondelis (US)

146.6

0.66

STS (second-line) peak sales of $130m, launched 2016; peak sales in platinum-sensitive ovarian cancer of $50m, 65% risk adjustment, 2020 launch; both assume 15% royalty from J&J.

Yondelis (Japan)

24.1

0.11

STS only: peak sales of €34m; 15% royalty from Taiho. 10% WACC.

Aplidin (multiple myeloma)

200.3

0.90

Global peak sales of $300m assuming 40% of MM patients ultimately receive fourth-line therapy and 25% penetration; pricing of $25k in EU with 25% US premium; 90% success probability in Europe, 65% in the US; launch 2018 in Europe, 2021 in the US; sold by Chugai in eight European territories (assume effective royalty of 25%) and direct in other EU regions, assume 25% royalty in US; includes €20m of near-term regulatory milestones out of €30m total Chugai milestones. No milestones included for other territories at this stage.

Zepsyre (resistant ovarian cancer)

346.1

1.56

Second-line, platinum-resistant ovarian cancer: peak sales of €193m; US and EU: 65% success probability, 2019 launch – sold direct in Europe and the US; Japan: 50% success probability, 2021 launch, 20% royalty.

Zepsyre (SCLC)

691.8

3.11

Peak sales of €680m; US and EU: 65% success probability, 2020 launch sold direct in Europe and US; Japan: 50% success probability, 2022 launch, 20% royalty.

Zepsyre (breast – BRCA2 mutated)

136.8

0.62

Peak sales of €250m; 45% success probability; US and EU: 2021 launch – sold direct in Europe and US; Japan: 50% success probability, 2023 launch, 20% royalty.

Zepsyre (endometrial cancer)

211.6

0.95

Peak sales of €198m; US and EU: 65% success probability, 2022 launch sold direct in Europe and US; Japan: 50% success probability, 2023 launch, 20% royalty.

Zepsyre upfront and milestones

47.7

0.21

Chugai upfront €30m, plus Chugai Japan development milestones assumed to be €35m of ~€70m total potential Chugai milestone payments (assumed to average €7m/year over 2017-21), risked at 50-90%; no Chugai sales-based milestones or milestones for other territories included in our forecasts at this stage.

Sylentis

7.0

0.03

Cumulative peak sales of $200m, with 20% probability of success, potential launch 2021, 10% royalty.

Genomica

57.7

0.26

Conservative 2% growth rate.

R&D

(354.2)

(1.59)

12.5% WACC.

SG&A

(302.2)

(1.36)

10% WACC.

Capex

(17.6)

(0.08)

55% of group capex for biopharma business.

Net cash/(debt)

(66.4)

(0.30)

At Q317

Total

1,839.2

8.28

Source: Edison Investment Research. Note: WACC of 12.5% used except where indicated otherwise.

Financials

PharmaMar reported that total sales rose by 0.6% to €139.6m through Q317. Sales in the biopharmaceutical area fell 4.1% to €69m, mainly due to Yondelis price erosion in some European countries. Sales in the consumer chemical segment grew by 2.1% to €60.4m thanks mainly to chalky-finish paints and other Rust-Oleum products. We have lowered our total revenue estimate by €2.8m for 2017 and by €1.1m for 2018. We adjusted Yondelis slightly downward, which was mitigated in part by increasing estimates for the consumer chemical segment.

R&D expenditure fell in the first nine months of the year by 3% to €55.7m driven mainly by the completion of clinical trials that were ongoing in 2016. As we had expected high growth in R&D spend this year, we have reduced our estimates by €11.6m for the year but by less than a million in 2018 due to new Phase III trials ramping up.

Adjusted EBITDA for the group was a loss of €3.7m through the first nine months compared to a loss of €5.6m in the same period last year. The improvement is due to revenue growth and containment of commercial (including reduced promotional expenses for the chemicals business) and R&D expenses. We have decreased our EBITDA estimate for 2017 but increased it for 2018 due to an expected delay in the milestone payments (risk-adjusted) on the launch of Aplidin (we had originally expected approval sometime in H217 and we think the milestones will most likely be received next year even with a positive CHMP decision this year).

Exhibit 7: Financial summary

€'000s

2014

2015

2016

2017e

2018e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

149,652

161,992

164,035

171,235

191,586

Cost of Sales

(40,765)

(45,705)

(43,971)

(47,461)

(50,001)

Gross Profit

108,887

116,287

120,064

123,774

141,585

R&D Expenses (gross)

(52,456)

(63,549)

(79,780)

(76,797)

(78,615)

Capitalised in-house R&D

5,979

3,258

1,357

1,753

1,800

Sales, General and Administrative Expenses

(57,043)

(74,067)

(71,550)

(64,346)

(60,320)

Other (milestones and royalties)

28,060

31,825

16,913

22,563

41,210

EBITDA

 

 

25,704

17,578

(11,463)

924

39,576

Operating Profit (before GW and except.)

22,095

11,297

(18,706)

(6,536)

31,892

Depreciation & Amortisation

(5,467)

(6,281)

(7,243)

(7,460)

(7,684)

Exceptionals

0

0

0

0

0

Operating Profit

20,237

11,297

(18,706)

(6,536)

31,892

Net Interest

(5,762)

(5,388)

(5,993)

(4,576)

(4,734)

Other

0

0

0

0

0

Profit Before Tax (norm)

 

 

16,333

5,909

(24,699)

(11,112)

27,158

Profit Before Tax (as reported)

 

 

14,475

5,909

(24,699)

(11,112)

27,158

Tax

(1,304)

654

592

0

0

Deferred tax

0

0

0

0

0

Profit After Tax (norm)

15,029

6,563

(24,107)

(11,112)

27,158

Profit After Tax (FRS 3)

13,171

6,563

(24,107)

(11,112)

27,158

Minority interests

20

25

25

0

0

Discontinued operations

(76)

0

0

(48)

0

Net income (normalised)

 

 

15,049

6,588

(24,082)

(11,112)

27,158

Net income (FRS3)

 

 

13,115

6,588

(24,082)

(11,160)

27,158

Average Number of Shares Outstanding (m)

222.2

222.2

222.2

222.2

222.2

EPS - normalised (c)

 

 

6.8

3.0

(10.8)

(5.0)

12.2

EPS - FRS 3 (c)

 

 

0.06

0.03

(0.11)

(0.05)

0.12

Dividend per share (c)

0.00

0.00

0.00

0.00

0.00

Gross Margin (%)

72.8%

71.8%

73.2%

72.3%

73.9%

EBITDA Margin (%)

17.2%

10.9%

-7.0%

0.5%

20.7%

Operating Margin (before GW and except.) (%)

14.8%

7.0%

-11.4%

-3.8%

16.6%

BALANCE SHEET

Fixed Assets

 

 

99,473

99,804

100,145

98,411

96,167

Intangible Assets

28,836

29,377

27,448

25,691

27,491

Tangible Assets

29,218

30,624

31,141

30,978

26,934

Other

41,419

39,803

41,556

41,742

41,742

Current Assets

 

 

101,916

112,135

120,992

108,114

122,487

Stocks

24,404

22,990

22,158

23,144

27,398

Debtors

36,989

40,200

62,652

44,259

44,616

Cash and current financial assets

35,511

45,625

32,367

35,357

45,119

Other

5,012

3,320

3,815

5,354

5,354

Current Liabilities

 

 

(82,626)

(70,623)

(87,164)

(84,697)

(80,214)

Creditors

(38,160)

(41,994)

(59,258)

(57,444)

(52,961)

Short term borrowings

(44,466)

(28,629)

(27,906)

(27,253)

(27,253)

Long Term Liabilities

 

 

(58,694)

(68,280)

(85,478)

(82,783)

(72,493)

Long term borrowings

(47,003)

(64,973)

(67,583)

(71,678)

(71,678)

Other long term liabilities

(11,691)

(3,307)

(17,895)

(11,105)

(815)

Net Assets

 

 

60,069

73,036

48,495

39,045

65,947

CASH FLOW

Operating Cash Flow

 

 

23,475

10,195

(3,040)

11,562

19,937

Net Interest

(1,000)

252

(5,000)

(4,576)

(4,734)

Tax

(366)

654

(374)

0

0

Capex

(10,179)

(9,221)

(6,093)

(6,193)

(5,440)

Acquisitions/disposals

4

0

129

0

0

Financing

(2,905)

6,169

(632)

(979)

0

Other

0

0

0

0

0

Net Cash Flow

9,029

8,049

(15,010)

(187)

9,763

Opening net debt/(cash)

 

 

64,585

54,886

46,910

61,984

62,550

Exchange rate movements

0

0

0

0

0

Other

670

(73)

-64

-379

0

Closing net debt/(cash)

 

 

54,886

46,910

61,984

62,550

52,788

Source: PharmaMar accounts, Edison Investment Research

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

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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

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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 PharmaMar 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 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

SNP Schneider-Neureither & Partner — Positioning the business for growth

2017 has been a year of major change for SNP, including two major acquisitions, debt and equity capital raisings, corporate restructurings, new product offerings launched and new training centres established. This has involved significant cost in both financial terms and management time. There has been €4m in one off costs, and management expects to report break-even at the EBIT level in FY17. Excluding one-off costs, the FY17 EBIT margin is expected be c 3.3%. Following the acquisitions, the group now has a presence in most major regions globally. Hence, SNP now looks better positioned to deliver on its goal to be the global leader in software-based transformation projects. Following the recent correction, we believe the shares look increasingly attractive on c 18x our FY19e EPS.

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