Onxeo — Update 23 August 2016

Healthcare

Onxeo

Key catalyst approaching

Company update

Pharma & biotech

23 August 2016

Price	€3.11
Market cap	€129m

Net cash (€m) at end H116		19.5

Shares in issue	41.5m
Free float	85%
Code	ONXEO

Primary exchange	Euronext Paris
Secondary exchange	OMX Copenhagen

Share price performance

%	1m	3m	12m
Abs	0.3	(1.6)	(21.3)
Rel (local)	(0.4)	(2.6)	(17.9)

52-week high/low

€4.5

€2.3

Business description

Onxeo is focused on orphan cancer and has three late-stage orphan oncology assets it could commercialise alone in Europe (Livatag, Beleodaq and Validive). Royalty-earning Beleodaq (belinostat) is launched in the US, along with two non-core, partnered, specialty products. Recent acquisition of DNA Therapeutics adds a Phase I stage asset in DNA repair field to Onxeo’s pipeline.

Next events

Start of Phase III Beleodaq combo trial	End-2016
Preclinical data from ongoing Livatag and Beleodaq collaborations	H216
AsiDNA preclinical data	H216/H117
Livatag Phase III data	Mid-2017

Analysts

Jonas Peciulis	+44 (0)20 3077 5728
Lala Gregorek	+44 (0)20 3681 2527

healthcare@edisongroup.com

Edison profile page

Onxeo is a research client of Edison Investment Research Limited

With its H116 results, Onxeo reported that R&D is progressing according to plan. Preliminary data from the Phase III ReLive trial with Livatag are due around mid-2017, which is the main catalyst in the next 12 months. Update on the newly acquired DNA repair asset, AsiDNA, revealed that the project could enter the clinic already next year. Although sales of Onxeo’s third product Beleodaq somewhat lagged our expectations, H116 operating costs were managed well, suggesting that the key catalysts are achievable with current cash.

Year end	Revenue (€m)	PBT* (€m)	EPS* (€)	DPS (€)	P/E (x)	Yield (%)
12/14	22.1	0.2	(0.05)	0.0	N/A	N/A
12/15	3.5	(20.0)	(0.44)	0.0	N/A	N/A
12/16e	3.5	(21.5)	(0.52)	0.0	N/A	N/A
12/17e	8.7	(16.8)	(0.41)	0.0	N/A	N/A

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

H116 results: Sales somewhat behind, costs in line

Onxeo reported H116 results, with recurring sales of its marketed products somewhat below our expectations but still representing 50% growth year-on-year, although from a low base of €1.2m in H115 to €1.8m in H116. The company mentioned that its partners Spectrum Pharmaceuticals and Cipher, which market Beleodaq (HDAC inhibitor for peripheral T-cell lymphoma, PTCL) and Sitavig (mucoadhesive formulation of acyclovir for herpes labialis) respectively, continue with intensive marketing efforts. Operating expenses were well in line with our expectations.

R&D progress according to plan

The development plan for AsiDNA, announced at the end of June, was a major R&D update, which provided more granularity about what lies ahead for the recently acquired first-in-class asset in the DNA repair field. Development progress with Beleodaq and Livatag is on track. The preparations for Beleodaq’s label-expansion Phase III trial in first-line PTCL are ongoing, in partnership with Spectrum and scheduled to start around end-2016. Of the planned 400 patients, 80% are now recruited in Livatag’s Phase III trial ReLive, with the first results expected in mid-2017, as guided previously.

Valuation: €339m or €8.2/share

Our valuation of Onxeo is largely unchanged at €339m or €8.2/share (from €343m or €8.3/share). The main adjustments include somewhat slower than expected Beleodaq sales uptake and a lower net cash position, partially offset by moving our model forward in time. Livatag Phase III preliminary data and results from preclinical studies with Beleodaq and Livatag in combination with other undisclosed anti-cancer compounds are the key catalysts within the next 12 months and achievable with current cash.

Update on AsiDNA: likely to move into clinic in 2017

According to the update on the development plans for AsiDNA, preclinical pharmacokinetic/ pharmacodynamic profile data after the intravenous administration should be obtained later this year, which will allow the project to progress into Phase I in 2017. Onxeo acquired AsiDNA, together with its original developer DNA Therapeutics, earlier this year. The compound has already been tested in Phase I DRIIM trial with 23 skin melanoma patients, where it was injected intratumourally or peritumourally alongside the radiation therapy. Onxeo’s plan is to expand AsiDNA’s potential by changing the administration route to intravenous administration.

Onxeo is able to leverage the existing clinical data from melanoma patients. Among other findings, lesions that were not injected with AsiDNA also demonstrated a response, indicating AsiDNA’s ability to circulate and potentially provide a systemic effect. Together with a good safety profile, this allowed for testing systemic delivery of AsiDNA (oral or intravascular), which in turn opens up possibilities for developing the drug in a variety of tumours and expanding product potential. Onxeo has not yet disclosed the first indication for AsiDNA, but the two likely indications are triple-negative breast cancer (TNBC) and platinum-resistant ovarian cancer, which we discuss in detail in our previous report.

First-in-class AsiDNA is based on signal-interfering DNA technology which, if introduced into a cell, acts as a signal mimicking the damage of the cell’s own DNA. AsiDNA then activates a cascade of repair proteins, which are recruited to ‘repair the damage’, as a result of which the actual damage of a cell’s DNA (such as from radiotherapy or chemotherapy) remains unrepaired, leading to cell death.

Beleodaq’s commercialisation and new R&D initiatives

In June Onxeo announced the first steps of an R&D initiative to develop belinostat in oral formulation. The newly obtained preclinical pharmacokinetic data on belinostat’s bioavailability in an oral formulation were positive. The oral formulation could open several opportunities for belinostat. This would be a competitive advantage compared to other PTCL treatments (more convenient administration than injectibles, likely better patient compliance, pain-free). Oral formulation would also allow for more flexibility in expanding to other indications and developing the drug in combination with other medicines. While still an early initiative and potential clinical development timelines are yet to be clarified, as a next step Onxeo plans to conduct preclinical in vivo efficacy studies.

With another new R&D initiative announced in July, Onxeo, together with the Royal College of Surgeons in Ireland (RCSI), will explore derivatives of belinostat (Beleodaq) with the goal of optimising the pharmacokinetic profile, which could lead to new IP. Research costs will be shared between the partners and Onxeo will have an option to license RCSI’s patents. Results are expected in 2017.

On the commercialisation front, Onxeo also released news about the addition of a new distributor, Pint Pharma, which will cover seven South American countries. The data filed with the NDA will most likely be sufficient to register Beleodaq in the same indication – second-line PTCL. Onxeo will receive an upfront payment, milestone payments and double-digit royalties for Beleodaq with a total deal value of $20m. While the timing for the registration remains somewhat undefined, Pint Pharma plans to establish an early access programme by end-2016.

Financials

Onxeo’s total revenues for H116 were €1.9m, of which €54k were non-recurring related to licensing agreements. Our focus was on recurrent sales, which totalled €1.8m. Onxeo does not provide a split per product, but breaks down sales into oncology products and other products. Consequently, the former category represents Beleodaq (€964k, up 48% y-o-y) and the latter Loramyc/Oravig and Sitavig (together €914k, up 4% y-o-y). Beleodaq grew substantially y-o-y, although from a low base and below our expectations, hence we have revised our sales ramp-up expectations downwards somewhat. Nevertheless, Beleodaq is the most advanced of Onxeo’s products, relatively recently marketed in the US by Spectrum since July 2014 and with at least another 10 years of IP protection, which provides leeway for market penetration. The drug is currently approved for second-line treatment of PTCL, but could also be developed for first-line treatment with the Phase III trial of Beleodaq in combination with standard-of-care chemotherapy to start around end 2016 (positive Phase I data released in December 2015).

Total H116 operating costs were in line with our expectations and came in at €13.0m versus €13.5m in H115. The only change to our cost estimates is the delay in sales and marketing costs related to Livatag, which we initially included in 2017, but now postpone to 2018. This allows time for Onxeo to deliver both preliminary (mid-2017) and full data readout from the ReLive Phase III study and file for regulatory approval in the case of a positive outcome. Following these changes, we have decreased our 2016 EPS estimate from -€0.48 to -€0.52, and increased our 2017 estimate from
-€0.46 to -€0.41.

Onxeo reported cash and equivalents at end-H116 of €19.6m (net cash €19.5m). In line with the company’s guidance, we believe this should be sufficient to fund operations well into 2017, likely until Q417.

Exhibit 1: Key changes to our financial forecasts

€m	2015	2016e			2017e
€m	Actual	Old	New	Change (%)	Old	New	Change (%)
Revenue	3.482	5.260	3.483	(34)	11.339	8.697	(23)
Operating profit (reported)	(22.334)	(21.707)	(23.614)	9	(20.878)	(18.682)	(11)
Profit before tax (reported)	(19.972)	(19.614)	(21.521)	10	(19.018)	(16.822)	(12)
Profit after tax (reported)	(17.648)	(19.614)	(21.354)	9	(19.018)	(16.822)	(12)
EPS (norm, €)	(0.44)	(0.48)	(0.52)	8	(0.46)	(0.41)	(12)

Source: Onxeo accounts, Edison Investment Research

Valuation

Our valuation of Onxeo is largely unchanged at €339m or €8.2/share from €343m or €8.3/share. The main adjustments include a somewhat slower than expected Belodaq’s sales uptake, although we have not changed our peak sales assumption. Together with the lower net cash position (H116), this was partially offset by moving our model forward in time. Our other assumptions remain unchanged, including the recently added TNBC indication with AsiDNA. AsiDNA has clearly added value to Onxeo’s R&D pipeline and, to capture that, we have focused on TNBC, although the company has not revealed the precise indication for this asset. TNBC has a significant unmet need with no novel targeted treatment approved (see our previous report for more details).

Preliminary data from the c 400-patient, 80%-recruited ReLive Phase III trial with Livatag for liver cancer patients (hepatocellular carcinoma) are due in mid-2017 and represent the main catalyst for the company in the near term, which is reachable with current cash. In preclinical studies Onxeo is also exploring both Livatag and Beleodaq in combination with other undisclosed anti-cancer compounds, which may also deliver interesting feasibility data in the coming months.

Exhibit 2: Onxeo rNPV valuation

Product	Indication	Launch	Peak sales (€m)	NPV (€m)	Probability (%)	rNPV (€m)	NPV/share (€/share)
Validive	Oral mucositis (H&N cancer)	2021	200	67.7	50%	33.3	0.8
Livatag	Liver cancer	2018	250	183.7	40%	70.4	1.7
Beleodaq US	PTCL	2014	80	40.0	100%	40.0	1.0
Beleodaq EU	PTCL	2020	60	65.3	70%	44.0	1.1
AsiDNA	TNBC	2024	1,110	179.6	15%	35.5	0.9
Loramyc/Oravig	Oropharyngeal candidiasis	2007	50	26.1	100%	26.1	0.6
Sitavig	Recurrent herpes labialis	2014	110	70.5	100%	70.5	1.7
Net cash (at end H116)				19.5	100%	19.5	0.5
Valuation				652.4		339.3	8.2

Source: Edison Investment Research. Note: Specialty products shaded. PTCL = peripheral T-cell lymphoma, TNBC = triple negative breast cancer.

Exhibit 3: Financial summary

	€000s	2010	2011	2012	2013	2014	2015	2016e	2017e
Year-end December		IFRS	IFRS	IFRS	IFRS	IFRS	IFRS	IFRS	IFRS
PROFIT & LOSS
Revenue		22,532	3,231	4,028	1,467	22,081	3,482	3,483	8,697
Cost of Sales		(859)	(750)	(375)	(264)	(249)	(337)	(453)	(453)
Gross Profit		21,673	2,481	3,653	1,202	21,832	3,145	3,030	8,244
EBITDA		3,065	(14,429)	(11,300)	(15,189)	(4,505)	(20,355)	(21,605)	(16,638)
Operating Profit (before amort. and except.)		2,698	(14,841)	(11,506)	(15,412)	184	(20,574)	(22,009)	(17,058)
Intangible Amortisation		(105)	(97)	(9)	(10)	(800)	(1,600)	(1,605)	(1,624)
Exceptionals		0	0	0	0	(4,861)	(160)	0	0
Operating Profit		2,593	(14,938)	(11,515)	(15,422)	(5,477)	(22,334)	(23,614)	(18,682)
Other		0	0	0	(29)	(77)	(29)	0	0
Net Interest		217	316	(33)	126	5	602	488	236
Profit Before Tax (norm)		2,914	(14,525)	(11,539)	(15,286)	189	(19,972)	(21,521)	(16,822)
Profit Before Tax (reported)		2,809	(14,622)	(11,548)	(15,325)	(5,549)	(21,761)	(23,126)	(18,446)
Tax		(0)	0	0	0	(2,150)	2,353	167	0
Profit After Tax (norm)		2,914	(14,525)	(11,539)	(15,315)	(2,038)	(17,648)	(21,354)	(16,822)
Profit After Tax (reported)		2,809	(14,622)	(11,548)	(15,325)	(7,699)	(19,408)	(22,959)	(18,446)

Average Number of Shares Outstanding (m)		13.6	17.7	17.7	20.7	40.5	40.5	41.0	41.5
EPS - normalised (€)		0.21	(0.82)	(0.65)	(0.74)	(0.05)	(0.44)	(0.52)	(0.41)
EPS - normalised and fully diluted (€)		0.21	(0.82)	(0.65)	(0.74)	(0.05)	(0.44)	(0.52)	(0.41)
EPS - (reported) (€)		0.21	(0.83)	(0.65)	(0.74)	(0.19)	(0.48)	(0.56)	(0.44)
Dividend per share (€)		0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0

Gross Margin (%)		96.2	76.8	90.7	82.0	98.9	90.3	87.0	94.8
EBITDA Margin (%)		13.6	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Operating Margin (before GW and except.) (%)		12.0	N/A	N/A	N/A	0.8	N/A	N/A	N/A

BALANCE SHEET
Fixed Assets		2,083	1,793	1,540	1,300	89,052	87,539	87,371	85,761
Intangible Assets		117	27	33	23	87,932	86,367	86,429	84,805
Tangible Assets		1,632	1,401	1,086	908	711	841	611	625
Investments		334	366	422	369	409	331	331	331
Current Assets		24,251	32,288	20,581	16,432	62,946	41,697	22,974	10,492
Stocks		38	1	3	3	65	106	142	142
Debtors		243	456	2,089	338	582	1,036	1,036	2,588
Cash		20,947	28,666	14,503	11,329	57,227	33,793	15,033	1,000
Other		3,023	3,164	3,986	4,762	5,073	6,762	6,762	6,762
Current Liabilities		(5,737)	(7,051)	(6,147)	(6,357)	(12,919)	(10,606)	(11,621)	(11,732)
Creditors		(5,680)	(6,881)	(6,090)	(6,266)	(11,290)	(10,537)	(11,552)	(11,663)
Short term borrowings		(57)	(170)	(57)	(91)	(1,630)	(69)	(69)	(69)
Long Term Liabilities		(1,745)	(4,128)	(4,231)	(3,487)	(17,108)	(15,831)	(15,831)	(20,690)
Long term borrowings		(1,131)	(2,237)	(511)	(303)	(138)	0	0	(4,859)
Other long term liabilities		(614)	(1,891)	(3,720)	(3,185)	(16,970)	(15,831)	(15,831)	(15,831)
Net Assets		18,852	22,902	11,742	7,888	121,971	102,799	82,892	63,831

CASH FLOW
Operating Cash Flow		3,492	(11,614)	(14,076)	(14,020)	(7,733)	(20,067)	(20,788)	(17,736)
Net Interest		(61)	(1,106)	1,837	333	843	579	489	236
Tax		0	0	0	0	0	(2,448)	714	42
Capex		(108)	(148)	(39)	(119)	(2)	(410)	(174)	(435)
Acquisitions/disposals		0	0	0	0	14,208	0	0	(1,000)
Financing		2,867	19,367	(46)	10,807	37,207	611	1,000	0
Dividends		0	0	0	0	0	0	0	0
Net Cash Flow		6,191	6,499	(12,324)	(3,000)	44,524	(21,735)	(18,760)	(18,893)
Opening net debt/(cash)		(13,569)	(19,760)	(26,259)	(13,935)	(10,935)	(55,459)	(33,724)	(14,964)
HP finance leases initiated		0	0	0	0	0	0	0	0
Other		0	0	0	(0)	0	0	0	0
Closing net debt/(cash)		(19,760)	(26,259)	(13,935)	(10,935)	(55,459)	(33,724)	(14,964)	3,928

Source: Edison Investment Research, Onxeo accounts. Note: Historic financials display standalone data only, with Topotarget consolidated from H214.

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