Archives

Free to access research and investor meetings in a post-MiFID2 world.

This research report is intended for use only by persons who qualify as professional investors or eligible counterparties (institutional investors) in the applicable jurisdiction, and not by any private individuals or other persons who qualify as retail clients.

Published to the market and investors on 28^th March 2019 @ 12.03pm (GMT).

Epigenomics (ECX-DE): 2018 results highlight strong underlying growth momentum
Recommendation: OUTPERFORM
Target Price: EUR4.01
Current Price: EUR1.76 (CoB on 27^th March 2019)

KEY TAKEAWAY

Having reached a number of critical milestones throughout 2018, Epigenomics reported FY2018 product sales of 0.8m (47% YoY), highlighting the company’s strong underlying growth momentum. While total sales of EUR1.5m (-18% YoY) were slightly below our revenue expectations, largely due to a reduction in licensing revenue associated with a one-off patent sale in Q4/2017, product sales in Q4/2018 increased by 7% YoY. We are revising our sales forecasts for FY2019E and out-years as a result of the recently announced termination of the collaboration with Chinese licensing partner BioChain and to account for the recently published 2019E revenue guidance in the range of EUR3.0m to EUR6.0m. We continue to see the positive commercial outlook of Epigenomic’s liquid biopsy tests due to a differentiated profile, fast readouts, large target markets and a significant health-economic impact. We maintain and reiterate both our OUTPERFORM recommendation and EUR4.01 target price (“TP”).

Strong underlying growth momentum expected to carry forward into 2019E

Epigenomics has reached a number of significant milestones throughout 2018, including a final reimbursement rate for Epi proColon of $192.00, CE marking of HCCBloodTest for liver cancer as well as a successful capital increase. Reimbursement coverage remains a primary focus for the company going forward, with FDA submission for HCCBloodTest also expected later this year. Success on both fronts would represent a turning point for the company and lay a strong foundation for sustainable long-term growth.

FY2018 financial review

Epigenomics reported total revenue for FY2018 of EUR1.5m and an operating loss of EUR12.9m. The EUR2.1m increase in R&D expenditure (48% YoY) is mainly attributable to the post approval study, we therefore anticipate lower R&D expenses for 2019E. Strengthened by a recent capital increase with gross proceeds of EUR22.3m, YE2018 cash stood at EUR17.1m, which should allow the company to fund operations into 2020E.

Adjusting 2019E sales and beyond

We have updated our 2019E and out-year forecasts to reflect the recent termination of the license agreement with BioChain and to account for 2019E revenue guidance of EUR3.0m to 6.0m. We expect Epigenomics to enter a phase of rapid growth, fuelled by a positive coverage decision for Epi proColon, and believe the results of the microsimulation study will facilitate much-anticipated inclusion into the American Cancer Society (“ACS”) updated colorectal screening guidelines.

Valuation suggests ample upside

With the recent CE marking for HCCBloodTest, in our view, the key uncertainty remains medicare coverage and inclusion into medical guidelines for Epi proColon. With the new liver product de-risking the commercial outlook, Epigenomics offers a highly attractive investment opportunity with significant potential for growth. We maintain and reiterate both our OUTPERFORM recommendation and TP of EUR4.01.

Kind regards,

Martin Piehlmeier | Analyst

goetzpartners Healthcare Research Team | Research Team

goetzpartners securities Limited

The Stanley Building, 7 Pancras Square, London, N1C 4AG, England, UK.

T +44 (0) 203 859 7725 | martin.piehlmeier@goetzpartners.com / healthcareresearch@goetzpartners.com

www.goetzpartnerssecurities.com

goetzpartners securities LinkedIn page

Registered in England No. 04684144.

Managing Directors: Dr Stephan Goetz, Martin Brunninger and Ulrich Kinzel.

goetzpartners securities Limited – Team Members

Equity Research Analysts – Martin Brunninger, Brigitte de Lima, Chris Redhead and Martin Piehlmeier.

Sales / Marketing – Erland Sternby.

Corporate Finance – Ulrich Kinzel, Wolf Dornbusch, Youchen Xin and Kieron Banerjee.

Corporate Access and IR – Tanya Tracey and Bettina Ellinghorst.

Compliance – Paul W. Dunne.

Click here to see our privacy policy.

GPSL has a formal client relationship with Epigenomics AG.

GPSL publishes and distributes “Investment” Research and “Corporate Sponsored” Research. Our Corporate Sponsored Research and investor meetings (e.g. NDRs, 1 to 1 meetings) are free to access and attend and is not classified as an inducement in a post-MiFID2 world, this is because the issuer is paying GPSL. GPSL does not offer any execution or market making services. This is a marketing communication as defined by the Financial Conduct Authority (“FCA”). The information herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).

In accordance with the General Data Protection Regulation (“GDPR“) – if you would like to be removed / unsubscribed from our CRM (also please note that you are free to contact GPSL at any time in the future to have your e-mail subscription amended), please e-mail:
researchproduction@goetzpartners.com

About GPSL: goetzpartners securities Limited is a member of the goetzpartners group, and a leading pan European investment bank and research company. We bring together a wide range of expertise, insights and innovations to advance the interests of our clients around the world. The fast-changing environment brings challenges for businesses and investors. Research innovation, digital transformation and disruptive business ideas reshuffle the corporate world at a relentless pace. Our sector knowledge and our global footprint bring together corporate intelligence and a deep understanding of the industry with a wide network of top decision makers. These collective insights help our clients to stay at the leading edge of change.

This research report is intended for use only by persons who qualify as professional investors or eligible counterparties (institutional investors) in the applicable jurisdiction, and not by any private individuals or other persons who qualify as retail clients.

This communication (including any attachments) from goetzpartners securities Limited (“GPSL”) is confidential and may contain information which is proprietary, privileged or otherwise legally protected against unauthorised use or disclosure. If you receive this communication in error or are not the intended recipient of this communication, please delete and destroy all copies in your possession, notify the sender that you have received this communication, and note that any review or dissemination of, or the taking of any action in reliance on this communication is expressly prohibited. GPSL shall not be liable for the improper or incomplete transmission of the information contained in this communication nor for any delay in its receipt or damage to your system. GPSL does not guarantee that the integrity of this communication has been maintained nor that this communication is free of viruses, interceptions or interference and makes no warranties in relation to these matters. This is not an offer or a solicitation to buy or sell securities or investment products, or an official confirmation. GPSL record electronic and phone communications in accordance with FCA and MiFID2 regulations, they will be monitored for regulatory and training purposes. GPSL is authorised and regulated by the Financial Conduct Authority of the United Kingdom (Firm Reference Number: 225563).

Click on the following link for the GPSL MiFID2 Investor Guidance Notice

GPSL Equity Research publications are available on the following aggregators and via news distribution circuits (For Institutional Use Only): AlphaMetry, AlphaSense, Bloomberg (GOET), Capital IQ, EQS, FACTSET, ResearchFN, Research Tree, RNS Reach, Sentieo and Thomson Reuters.

Please copy the below link and paste it into your browser for the full pdf version of the equity research report:

https://gp.bluematrix.com/sellside/EmailDocViewer?encrypt=811c876a-dcc3-4a88-afcd-30ae5a845a2a&mime=pdf&co=gp&id=paul.dunne@goetzpartners.com&source=libraryView

Free to access research and investor meetings in a post-MiFID2 world.

This research report is intended for use only by persons who qualify as professional investors or eligible counterparties (institutional investors) in the applicable jurisdiction, and not by any private individuals or other persons who qualify as retail clients.

Epigenomics AG Reports Results for Financial Year 2018

Berlin (Germany) und San Diego, CA (U.S.A.), March 27, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”) today announced the financial results (according to IFRS) for the year ended December 31, 2018.

KEY HIGHLIGHTS

Financial

• Total revenue of EUR 1.5 million and EBITDA (before share-based payment expenses) of EUR -11.4 million (compared to 2017: EUR 1.9 million and EUR -9.4 million, respectively).
• Liquidity of EUR 17.1 million (incl. marketable securities) at year-end following a successful capital raise in October 2018 (December 31, 2017: EUR 13.7 million)

Corporate

• In December 2018, Centers for Medicare & Medicaid (CMS), the U.S. National Health Insurance, published its official Clinical Lab Fee Schedule (CLFS) 2019, which includes the final reimbursement rate of USD 192.00 for the Epi proColon blood test.
• Epigenomics AG obtains CE Mark for blood test to aid in detecting liver cancer among patients with cirrhosis, which will be commercialized under the brand name HCCBloodTest.

First quarter 2019

• On January 7, 2019, the Company announced positive results from a microsimulation model for the Epi proColon blood test. Microsimulation models are utilized by various screening guideline groups in the U.S. to aid in the development of screening recommendations.
• Reintroduction of the bi-partisan “Donald Payne Sr. Colorectal Cancer Detection Act” (HR 1765) to the U.S. House of Representatives at the end of March 2019 as a necessary step on the legislative path to reimbursement.

Greg Hamilton, Chief Executive Officer of Epigenomics AG: “In the past fiscal year, we achieved some critical milestones including the reimbursement rate for Epi proColon of USD 192.00 per test, completion of the microsimulation model, CE marking of our HCCBloodTest for liver cancer and a successful capital raise. While we did not receive Medicare coverage in 2018, we made progress on both the legislative and NCD paths. We believe we are positioned to receive a positive coverage decision in 2019, which will be a turning point for Epigenomics”.

Financial results 2018

• Total revenue was EUR 1.5 million in fiscal year 2018 (2017: EUR 1.9 million). The decrease is due to a reduction of EUR 0.6 million in licensing revenue attributed to the one-time patent sale in Q4 of 2017. This decline in licensing revenue was partly offset by an increase of 47% in product revenue.
• Operating loss (EBIT) amounted to EUR -12.9 million in 2018 (2017: EUR -10.3 million), the net loss for the year to EUR -12.7 million (2017: EUR -10.2 million). The change from 2017 was driven primarily through an increase in R&D of EUR 2.1 million attributed mainly to the post approval study. The loss per share rose to EUR -0.47 (2017: EUR -0.44).
• Cash consumption decreased to EUR 9.6 million (2017: EUR 10.1 million). With a cash inflow from financing activities of EUR 13.3 million (2017: EUR 11.5 million), net cash flow was EUR 3.6 million (2017: EUR 1.4 million).
• The Company’s liquidity (including marketable securities) increased to EUR 17.1 million at year-end 2018 (Dec. 31, 2017: EUR 13.7 million).

Outlook 2019

Revenue

• We estimate increased U.S. test volume demand based upon the new reimbursement rate of USD 192.00. As a result, the Company expects revenue in 2019 within the range of EUR 3.0 million to EUR 6.0 million even without Medicare coverage.

EBITDA

• For 2019, we expect EBITDA before share-based payment expenses to remain unchanged from the previous year’s guidance in a range of EUR -11.5 million to EUR -14.0 million.

Cash consumption

• Based on the Company’s 2019 business plan, we expect cash consumption to be in line with our EBITDA guidance (before share-based payment expenses).
• The Company’s financial position was significantly strengthened by the successful capital increase in October 2018. The 2018 financial year was concluded with cash and cash equivalents and marketable securities in the amount of EUR 17.1 million, which means that our financial resources are sufficient at our projected cash consumption rate to support the Company’s operations well into 2020.

Further information

The annual report 2018 can be downloaded from the Epigenomics Website at: https://www.epigenomics.com/news-investors/financial-reports/

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 2.30 pm (CET) / 9:30 am (EDT). The webcast can be accessed on the company’s website: https://www.epigenomics.com/news-investors/financial-reports/

The dial-in numbers for the conference call are:

Dial-in number within Germany: +49 30 8687 1728
Dial-in number within the UK: +44 1635 598 062
Dial-in number within the U.S.A.: +1 516 269 8983

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.
 

About Epigenomics
Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact:
Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-Mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-Mail: ir@epigenomics.com

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Correction of the Corporate News of March 15, 2019, 12:40 pm:

U.S. Representatives Payne and Marchant Introduce Bi-Partisan Colorectal Cancer Detection Bill

Legislation aims to provide coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests

Berlin (Germany) and San Diego, CA (U.S.A.), March 15, 2019 – Representatives Donald Payne, Jr (D-NJ) and Kenny Marchant (R-TX) today introduced the ”Donald Payne Sr. Colorectal Cancer Detection Act” (HR 1765) to the United States House of Representatives in Washington D.C. This House Bill aims to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer (CRC) screening blood-based tests.

“Screening utilizing blood testing mitigates patient barriers associated with typical colorectal cancer screening methods. The House Bill addresses the last barrier for Medicare patients – payment,” said Greg Hamilton, Chief Executive Officer of Epigenomics AG. “The passing of this bill provides millions of unscreened Americans access to CRC screening and ultimately saves thousands of lives.”

About colorectal cancer (CRC)

Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new CRC cases and about 76% of CRC deaths and the associated costs. Approximately $18 billion is spent annually on this preventable disease in the U.S. Thereof, over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed. The addition of the blood-based methods to the Medicare covered services would increase screening access in both urban and rural areas where populations are less likely to be screened.

The Payne/Marchant effort is a bipartisan effort to address appropriate use of health care resources.

About Epi proColon(R)

Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample draw as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

For more information on Epi proColon, visit www.epiprocolon.com.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

Contact Epigenomics AG
Frederic Hilke
IR.on AG
Phone +49 221 9140 970
ir@epigenomics.com

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.