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2016-05-10

Saniona: Interim Report for Saniona AB (PUBL)

Saniona made a flying start in Q1 with three new Collaborations and an
increase in revenues of 227%

Financial highlights

Q1 2016 (Q1 2015)

· Net revenues were KSEK 15,853 (4,848)
· EBIT was KSEK -1,058 (-5,103)
· Earnings per share were SEK -0.12 (-0.30)
· Diluted earnings per share were SEK -0,12 (-0.30)

Business highlights in Q1 2016

· Saniona and Upsher-Smith, through its wholly-owned UK subsidiary
Proximagen, sign collaboration agreement for the research and
development of therapeutics for neurological disorders. Proximagen is
granted exclusive worldwide rights to develop, manufacture and
commercialize medicines identified through the collaboration. Saniona
is entitled to pre-commercial milestone payments of up to US$30
million (about SEK 250 million) and tiered royalties on product
sales.

· Saniona and Medix sign a drug development and commercialization
collaboration. Medix is granted exclusive rights to develop and
commercialize tesofensine and Tesomet in Mexico and Argentina. Medix
will finance the clinical development in the two countries. Medix
intends to initiate Phase 3 clinical studies for tesofensine for
obesity later this year. Saniona retains all rights to tesofensine
and Tesomet in the rest of the world including clinical data
developed by Medix. Medix will pay Saniona an upfront payment of US$
1.25 million (about SEK 10.5 million), regulatory milestone payments,
and double-digit royalties on product sales.

· Saniona is awarded a grant of up to USD 590,700 (approximately SEK
5.1 million) by The Michael J. Fox Foundation for Parkinson's
Research to develop drug candidates for the treatment of Parkinson's
disease.

· Saniona obtains patent in the United States until 2033 for the
combination of tesofensine and metoprolol.

· Saniona appoints Laika Consulting for IR and PR support and issue
the first newsletter.

· Saniona obtains approval by BfArM to initiate Phase 2a clinical
study for Tesomet in type 2 diabetes patients.

Significant events after the reporting period

· Saniona initiates recruitment of patients in the Phase 2a clinical
studies for Tesomet in type 2 diabetes. The trial comprises a total
of 60 patients. Saniona expects to report the results from the trial
within one year.

· Saniona submits an application for trading on Nasdaq First North
Premier as a step in company's plans to list its shares on Nasdaq
Stockholm Small Cap later in 2016.

· Saniona initiates extended preclinical research studies on backup
compound to AN363; AN363 is put on hold

· Saniona invests in a new company, Initiator Pharma A/S, and spins
out three programs, which Saniona does not plan to pursue internally.

Comments from the CEO

"Saniona made a flying start in Q1 2016 where we signed three new
collaboration agreements. This had direct impact on revenues, which
increased by 227% compared to Q1 2015. After the end of the quarter
we have started a Phase 2 study for Tesomet and announced our
intention to be listed on Nasdaq First North Premier in May, a step
on the road to Nasdaq Stockholm. I see great opportunities for the
company in the future," says Jørgen Drejer, CEO of Saniona.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail:
tf@saniona.com

Letter from the CEO

"We have had a fantastic start in 2016 with three new collaboration
agreements during the first quarter. All agreements are important to
us and enable us to report significantly higher sales compared to
first quarter last year.

· The agreement with Upsher-Smith relates to one of our early stage
discovery programs which we have not discussed in public previously.
It illustrates that we are able to create significant value for our
shareholders by entering into early stage collaborations on assets
belonging to our broad pipeline of discovery programs. In the long
term, Saniona may receive up to USD 30 million (about SEK 250
million) in milestone payments plus royalties on net sales of
products coming of this collaboration.

· The agreement with Medix is highly interesting and illustrates how
Saniona may finance late stage clinical development of specific
programs. Furthermore, the collaboration takes the company a
significant step forward towards the market and potential royalty
income since Medix intends to start Phase 3 trials this year.

· The agreement with Michael J. Fox Foundation for Parkinson's
Research relates also to one of our early stage discovery programs
which we have not discussed in public previously. We are very proud
that The Michael J. Fox Foundation for Parkinson's Research supports
the development of our technology and we are pleased to be
collaborating with such a prestigious organization. Moreover, the
grant illustrates how Saniona may finance early stage programs and
still retain the commercial rights.

During the quarter, two other important achievements should be noted.
First, we obtained a patent in the United States covering the
combination of tesofensine and metoprolol, which are the active
ingredients in our internal lead candidate, Tesomet. Second, we
obtained approval by the German authorities, BfArM, to initiate Phase
2a clinical study for Tesomet in type 2 diabetes.

We have continued in high pace after the end of the quarter.

First, we started a Phase 2 clinical study for Tesomet. This is in
every way an important milestone for the company. Our vision for
Tesomet is to develop a new type of treatment for type 2 diabetes
which can bring certain groups of patients in complete remission. The
market is huge and the clinical need significant. Therefore, Tesomet
has the potential to become a blockbuster if developed successfully.

Second, we submitted an application for trading on Nasdaq First North
Premier in May as a step in company's plans to list its shares on
Nasdaq Stockholm Small Cap later this year. The aim of the Nasdaq
Stockholm listing is to make the company more visible for foreign
investors and not least institutional investors, who in most cases do
not have a mandate to invest in companies listed at AktieTorget and
First North.

Third, we decided to initiate extended non GLP preclinical studies on
a backup compound to AN363. We remain highly enthusiastic about the
concept of using GABAA ?2, ?3 subtype specific compounds for chronic
pain. However, we are still concerned about using AN363 for chronic
pain still not having a clear understanding of the observed
toxicological finding in the rat. Rather than continuing an expensive
and time consuming investigation of this finding without any
guarantee for success, we have concluded that a more constructive
path forward is to focus on a backup compound from the broad
preclinical program.

Finally, we participated in the formation of a new company, Initiator
Pharma A/S, which subsequently acquired three Saniona programs, which
we do not intend to pursue internally. Saniona commercializes its
research efforts through three different business models including
internal development in early phases of drug development, through
early stage research collaborations, and through spin-outs. The
formation of Initiator Pharma represents a variant of the third
model. The intention is that Initiator Pharma applies for listing at
AktieTorget in Sweden and that Saniona's shareholding in Initiator
Pharma is distributed to Saniona's shareholders before the listing.
We have applied for Lex ASEA in Sweden with the aim of distributing
our shareholding in Initiator Pharma as a specific dividend to our
shareholders. By pursuing this opportunity, we hope to create a new
interesting company to the benefit of patients and Saniona's
shareholders.

If I should summarize the first quarter in one word it would be
"fantastic". However, we know that superlatives of the past do not
help us in the future. We have retained a high pace after the quarter
and we intend to continue to do so in the future. We have still a lot
to do, the opportunities are significant and the future looks
bright."

Jørgen Drejer

CEO, Saniona AB

About Saniona

Saniona is a research and development company focused on drugs for
diseases of the central nervous system, autoimmune diseases,
metabolic diseases and treatment of pain. The company has a
significant portfolio of potential drug candidates at pre-clinical
and clinical stage. The research is focused on ion channels. Saniona
has ongoing collaboration agreements with Upsher-Smith Laboratories,
Inc., Productos Medix, S.A de S.V and Saniona's Boston based spinout
Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Inc.
Saniona is based in Copenhagen, Denmark, where it has a research
center of high international standard.

Vision
Saniona will be a leading biotech company within the field of ion
channel-dependent diseases.

Business idea

Saniona will discover and develop better medical treatments in areas
with significant unmet medical needs through modulation of ion
channels.

Overall objective

Saniona's overall objective is by itself and together with partners to
develop and provide new medicines for severe diseases, more
specifically diseases of the central nervous system, auto-immune
diseases, metabolic diseases and treatment of pain.

Business model

The company commercializes its research efforts through the following
3 business models:

· By internal development of selected programs through the early
phases of drug development before out-licensing to pharmaceutical
companies who will take over the further development of Saniona's
programs and typical pay upfront, milestone and royalty payments on
product sales to Saniona;

· Through early stage research and development collaboration with
pharmaceutical companies who will fund the research and development
activities and pay upfront, milestones and royalty payments on
product sales to Saniona; and

· Through joint ventures or spin-outs, where Saniona's financial
partner will obtain a share of the upside by financing the
development of one of Saniona's programs.

Project portfolio

Saniona currently has nine active programs of which five are financed
through grants, by collaborations with partners, or in joint
ventures/spin-outs. Saniona's pipeline is set in attached pdf-file.

In addition to the active pipeline shown above, Saniona has a range of
validated drug discovery assets as well as clinical stage assets
(e.g. AN788 and AN761) positioned for partnering or spin-out.

Market

Saniona's research is focused in the field of io...

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