Orexo Interim Report Q2 2019

Improving all fundamentals

UPPSALA, Sweden, July 11, 2019 /PRNewswire/ --

Q2 2019 highlights

• Total net revenues of SEK 201.2 million (199.7), up 0.8 percent and 19.1 percent when excluding ex-US milestone payment of SEK 30.8 million in Q2 2018
• Zubsolv US net revenues of SEK 184.4 million (158.4), up 16.4 percent in SEK and 6.7 percent in local currency
• EBITDA of SEK 60.4 million (50.6), up 19.4 percent
• US EBIT of SEK 87.5 million (55.5), up 57.6 percent
• Cash flow from operating activities of SEK 46.1 million (39.0), building a cash balance of SEK 697.0 million (494.8)
• Net earnings of SEK 54.6 million (50.1), up 9.0 percent

Important events after the end of the period

• Signed license and supply agreement for Zubsolv in Australia and New Zealand with Mundipharma Pty Ltd.
• SEK 32.5 million (10 percent) of the total corporate bond loan will be prepaid in August 2019

SEK m, unless otherwise stated	2019 Apr-Jun	2018 Apr-Jun	2019 Jan-Jun	2018 Jan-Jun	12 mth Jul 2018- Jun 2019	12 mth Jul 2017- Jun 2018
Net revenues	201.2	199.7	375.5	339.4	819.2	696.7
whereof Zubsolv US net revenues	184.4	158.4	346.1	289.5	678.2	537.1
Cost of goods sold	-31.3	-37.6	-56.6	-86.0	-142.4	-168.4
Operating expenses	-117.1	-116.7	-265.1	-229.9	-550.8	-433.7
EBIT	52.8	45.4	53.8	23.5	126.0	94.5
EBIT margin, %	26.2	22.7	14.3	6.9	15.4	13.6
US EBIT	87.5	55.5	159.4	80.8	276.7	132.4
US EBIT margin, %	47.4	35.0	46.1	27.9	40.8	24.6
EBITDA	60.4	50.6	72.3	33.7	155.0	115.2
Earnings per share, before dilution, SEK	1.54	1.45	1.93	0.70	5.1	2.29
Earnings per share, after dilution, SEK	1.51	1.45	1.90	0.70	5.0	2.28
Cash flow from operating activities	46.1	39.0	97.1	144.9	193.3	214.6
Cash and cash equivalents	697.0	494.8	697.0	494.8	697.0	494.8

Unless otherwise stated in this report, all data refers to the Group, and numbers relate to the actual quarter while numbers in parentheses relate to the corresponding period in 2018.

Strong fundamentals fueling business development and pipeline progress

Following a strong first quarter, I am pleased to report that the second quarter has continued on the same positive trajectory. Zubsolv remains the core driver of Orexo's strong financial performance and record-high profitability. Zubsolv continues to demonstrate resilience to increased competition and with greater profit contribution from our US operations, we remain focused on expanding our pipeline and product portfolio with new assets.

Strengthened financial performance - EBITDA reached SEK 60.4 million
The second quarter of 2019 marks the first quarter in many years where our legal expenses are immaterial, and where the full impact of revenue growth and efficiency improvements are reflected in the financial health of the business. The second quarter has been the strongest financial period for the company to date, when excluding milestone payments. Isolating the financial performance of US operations, the EBIT margin reached 47 percent and contributed to our overall profitability with SEK 87.5 million (USD 9.2 million), a significant improvement of 58 percent in SEK from last year. With a cash position of SEK 697 million, our main focus is to expand our pipeline and to identify commercially attractive assets to drive future growth.

Business development gaining traction
Today, Orexo is in a strong position to engage in partnering and new business activities, thanks to our commercial platform in the US, a profitable business with strong patent protection for Zubsolv, and a solid cash position. We are actively engaged in new business and partnering discussions to ensure the longer-term growth of the business and we are an increasingly attractive partner in the opioid addiction market and its adjacents treatment areas. We are currently in negotiations for the rights to new and existing products. Assuming the negotiations materialize, we would expect to present our first agreement in the second half of 2019.

Development programs making good progress
Our three most advanced internal projects continue to progress as planned. The next significant milestone will be the phase I study of OX338, a sublingual formulation with ketorolac for the treatment of pain, planned for Q4 this year. For OX338, OX124 and OX125 we feel confident in the clinical development risk profile of these programs and continue to work towards realizing their commercial potential. From an external development perspective, we are also pleased to see our partner, Gesynta Pharma AB, progress OX-MPI (microvascular disease) into a phase I clinical trial.

Market Dynamics - Market access is key
The current trend in the addiction market is for payers to provide more product choice to patients. This would benefit Orexo in fast-growing public markets where Zubsolv currently has fewer reimbursement agreements. However, it also poses a risk in the form of greater competition when it comes to signing and keeping exclusive contracts for Zubsolv. We expect United Health Group will start reimbursing generic products later this year, but will also maintain Zubsolv in the current position as a preferred formula with unrestricted reimbursement. We have recently seen a similar change with Humana, where we lost some percentage points in market share, but our sales volumes have remained resilient and we have seen the Zubsolv demand increase by 3 percent since last quarter, despite increased generic competition. This demonstrates our competitive edge when patients and clinicians are aware of the benefits of Zubsolv over generic products.

Summary and outlook
2019 is on track to be Orexo's strongest year to date, both financially and operationally. Zubsolv remains a key driver of growth for the business, while management intend to build on the progress made to ensure the longer-term health of the company. To this end we will continue to expand our pipeline and product portfolio to offer best in class treatment options where they are needed most.

Uppsala, Sweden, July 11, 2019
Nikolaj Sørensen
President and CEO

For further information, please contact
Nikolaj Sørensen, CEO and President, Joseph DeFeo, EVP and CFO or Lena Wange, IR & Communications Manager
Tel: [phone] Email: [e-mail]

Presentation
At 2.00 pm CET, the same day as the announcement of the report, Orexo invites analysts, investors and media to attend an audiocast with a web presentation where Nikolaj Sørensen, CEO, and Joseph DeFeo, CFO, will present the report. After the presentation a Q&A will be held. Questions can also be sent in advance to [e-mail], no later than 11.00 am CET. Please view the instructions below on how to participate.
Internet: https://tv.streamfabriken.com/orexo-q2-2019
Telephone: SE: [phone] UK: [phone] US: [phone]
The presentation material will be available on Orexo's website prior to the audiocast.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 am CET on July 11, 2019.

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Orexo Q2 2019 Interim Report published July 11 2019