CREATING A FOOTPRINT IN UNDERSERVED NICHES

Presentation at BioEurope, Köln

November 7-9, 2016

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Moberg Pharma’s results could be materially affected.

The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research and product development, manufacturing and commercialization, the impact of competitive products, patents, legal challenges, government regulation and approval, Moberg Pharma’s ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in Moberg Pharma AB’s interim or annual reports, prospectuses or press releases.

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Disclaimer

• Founded 2006, 35 employees, offices in Stockholm & New Jersey

• Net Sales grew to 276 MSEK ($35m), trending to ca $55m after Q316 deal

– U.S. OTC Sales operations

– Products sold in 40+ countries

• Focus in OTC/Dermatology/Topicals

– Leading U.S. OTC SKU in Nail Fungus

– MOB015 in Phase 3, BUPI in Ph 3 prep

• 6 M&A transactions in last 4 years

• Partnered with 3 top 50 Global Pharma co’sKerasal Nail/Emtrix

• Market Cap ~ 700MSEK (OMX:MOB)

In a nutshell

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Moberg Pharma

Net Sales, MSEK

Launches in Asia drive RoW product sales

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Majority of revenue from direct OTC sales

Channel Product Geographies

Distribution of revenue, January – June 2016

RoW17%

Europe 9%

Americas 74%

Other31%

Nalox / Kerasal Nail58%

Divested products

12%Sales via distributors

27%

Direct OTC Sales 73%

• MOB-015 – Phase 3 enrollment starts Q3 2016

– IND approved by the FDA and CTA by Health Canada and in Europe (Germany and Poland)

– Patent granted in multiple territories, incl U.S., EU, Japan and Canada

• BUPI – Phase 3 preparations ongoing

– Positive Phase 2 results for BUPI in Q116

– License/Dev Agreement with Cadila. Cadila conducts a Phase 3 trial in India, rights in India/Africa

– Moberg sponsors one Phase 3 trial in Europe, co-financed by Eurostars grant

– Building on Topical drug delivery know how

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Pipeline assets – target leadership in two niches

Pipeline Asset Indication Status

Peak sales potential, m$ USP

MOB-015 Onychomycosis Phase 3 250-500 Topical terbinafine with fast visible improvement and superior cure rates

BUPI Oral Mucositis and oral pain

Phase 3 preparation

50-100 Lozenge formulation with effective pain relief for 2-3 hrs (vs 0,5 hrs for competition)

MOB-015

Medical need

• Common disease, affecting approximately 10% of the population

• Large unmet need for an efficacious and safe topical treatment of onychomycosis, current products have insufficient efficacy (topicals) or safety issues (orals)

Moberg Pharma Invention

• Patented terbinafine formulation with excellent penetration ability through human nail

Expected benefits

• Superior mycological and clinical cure rates compared to other topical treatments

• Early visible improvement of nail appearance due to keratolytic and humectant properties of the vehicle

• Excellent safety profile

MOB-015

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Meeting the medical need in Onychomycosis

Indication Distal Subungual Onychomycosis without matrix involvement.

Product/IP Topical solution of terbinafine with high capacity to penetrate nailPatents granted in all major territories, term to 2032

Dosing Once daily for 48w– no filing needed, simple applicationPotential to reduce to 24-36w

Target USPs

Superior cure rates – Mycological and Clinical

First visible improvement within 2-4 weeks

Shorter treatment time – potentially 6 months

MOB-015

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Product profile

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Ex vivo results, in vivo results are also available

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MOB-015 generates high terbinafine concentrations in nails

* Hui, Maibach et al, Drug Development and Industrial Pharmacy, 2012; Franz cell experiments withhuman nail; Amount TBF in the deeper part of the nail plate

** Schatz F, et al; Clin Exp Dermatol, 1995 Sep;20(5):377-83

Terbinafine concentration in human nail in vitro, µg/g nail

0,5

> 613

Oral terbinafine therapy**MOB-015*

LION study demonstrated 40% mycological cure after 6 months

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Today’s golden standard is oral terbinafine

Source: Double blind, randomized study of continous terbinafine compared with intermittent itraconazole in the treatment of toenail Onychomycosis, BMJ 1999

MOB015 Phase 2 results

• Open, single-centre, phase 2 study of topical MOB015B treatment in patients with distal subungual onychomycosis (DSO).

• Patients with clinically suspected DSO (25-75% disease involvement) of at least one great toenail were screened.

• Diagnosis was confirmed through positive culture for dermatophytes.

• An affected great toenail was selected as target nail for all subsequent assessments. However, the IMP was applied to all affected finger- and /or toenails once daily at bedtime.

• Terbinafine concentration in plasma was measured after 4 weeks and in nail and nail bed tissue after 24 weeks (n=8)

• Patients applied treatment once daily during 48 weeks after which a follow-up and wash-out period without treatment of 12 weeks ensued.

• The primary efficacy variable was the proportion of patients with mycological cure defined as negative culture and negative direct microscopy at 60 weeks.

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Study design/Methods

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Treatment administered

MOB015 is a moderately viscous solution containing 10% terbinafine

MOB015 was applied to affected nails by covering each nail with a thin layer of solution once daily at bedtime. The solution should also be applied under the free edge of the nail. After application, the nails were to be allowed to dry for approximately 5 minutes but not washed until earliest next morning.

All patients received prophylactic treatment of the feet with terbinafine 1% cream applied once daily for 7 days starting from the baseline visit. The patients were instructed to avoid apply the cream on the nails.

• Proportion of patients with mycological cure of the target nail, defined as negative fungal culture and negative direct microscopy, at 60 weeks

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Efficacy variables

Primary efficacy variable

Secondaryefficacy variables

• Mycological cure of the target nail at 12, 24 and 36 weeks

• Negative fungal culture of the target nail at 12, 24, 36 and 60 weeks

• Negative direct microscopy of the target nail at 12, 24, 36 and 60 weeks

• Negative PCR at 12, 24, 36 and 48 weeks

• Complete cure (negative fungal culture, negative direct KOH microscopy and physician’s Global Evaluation Score=5) at 12, 24, 36 and 60 weeks

• Negative culture and microscopy and physician’s GES =4 or 5 at 12, 24, 36 and 60 weeks

• Patient’s subjective score at 4, 12, 24, 36, 48 and 60 weeks

• Physician’s Global Evaluation Score at 4, 12, 24, 36, 48 and 60 weeks

• Terbinafine concentration in the nail and nail bed at 24 weeks

Screened 37

Included 25

Applied IMP at least once 25 (100.0%)

Completed 24 (96.0%)

Withdrawn 1 (4.0%)

Full analysis set (FAS) 25 (100.0%)

Per protocol analysis set (PPAS) 20 (80.0%)

Safety analysis set 25 (100.0%)

Percentages are based on the number of included patients.

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Disposition of patients

NUMBER OF PATIENTS

NUMBER OF PATIENTS IN EACH ANALYSIS SET

MOB-015

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Phase 2 results demonstrates efficacy and safety

Source: Moberg Pharma data on file, MOB-015 phase II study

* 54% of patients completing the treatment (13 of 24), 52% of FAS (13 of 25) and 60% of PPAS** Means 10% or less clinical involvement*** Post-hoc analysis

MYCOLOGICAL CURE AT 60 WEEKS*

MYC CURE AT 24 WEEKS

NEGATIVE CULTURE AT 60 WEEKS

MYC CURE AND ALMOST CURED OR CURED**

CLEAR NAIL GROWTH***

TBF IN NAIL BED (MEDIAN) 40X ORAL

TBF IN NAIL (MEDIAN) 1000x ORAL

54%

40%

100%

29%

>4.5 mm

45 µg/g

1610 µg/g

Target nail photos from MOB-015 phase 2– Examples of successfulresults (Visit 8 is at 60 weeks)

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Example of successful treatment with MOB-015

Before After

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Example of successful treatment with MOB-015

Before After

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Example of successful treatment with MOB-015

Before After

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Example of successful treatment with MOB-015

Before After

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Example of successful treatment with MOB-015

Before After

Pat nr 1011

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Example of severe nail in Phase 2

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Phase 2 results indicate that MOB015 has potential to become Best-in-Class

Mycological cure

Active Product Company Form at 6 months at 52/60 weeks Comment

Terbinafine MOB-015 Moberg Pharma Topical 40%1) 54% 25-75% affected*

Ciclopirox Penlac Valeant Topical - 29-36%2) 20-65% affected

Tavaborole Kerydin Anacor Topical - 31-36% 20-60% affected

Efinaconazole Jublia Valeant Topical - 54% 20-50% affected**

Amorolfin Loceryl Galderma Topical - n/a3)

Terbinafine Lamisil Novartis Oral 40%4) 75%4)

Itraconazole Sporanox J&J Oral 25-30%4) 40-50%4)

Source: 1)Moberg Pharma Phase 2 data, AAD poster 2015; 2) Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment oftoenail onychomycosis. J Am Acad Dermatol 43(4 Suppl):S70-80 (2000 Oct); 3) Mycological cure rates have not been published for Loceryl using the standard definition, which is the combination of negative fungal culture and KOH microscopy; 4) Double blind, randomized study of continous terbinafinecompared with intermittent itraconazole in the treatment of toenail Onychomycosis, BMJ 1999;

*Mean involvement was ca 60%**Mean involvement was 36%

Phase 3 and Regulatory

• 54% mycological cure, in severe nails (60% mean involvement)

• Excellent clinical improvement and significant clear nail growth (photo documentation)

• High terbinafine levels in patients:- In nail bed: 45 µg/g (median value) 40x Oral TBF - In nail: 1610 µg/g (median value) 1000x Oral TBF

• Safe – low plasma levels of TBF 1/1000 Oral TBF

• Including mild/moderate patients in Phase 3 (only 20-50% nail involvement), will increase cure rates, supported by:

– K101 (Nalox) Phase 3 (n=493): 40% higher mycological cure rate in stratum with 25-50% affected nail area (27,1%) vs stratum with 50-75% affected nail area (19,1%)

– In MOB-015 Phase 2: 70% mycological cure in 10 patients with <60% affected nail area

– Jublia Phase 3: Significantly higher cure rates in 25-40% vs 40-50% affected nails

– High mycological cure rate and significant clear nail growth in severe nails Complete cure will be achieved in milder nails

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Rationale for the superiority of MOB-015

Target Product Profile for mild-moderate nails vs Jublia- Jublia reached $400m sales in 18 months after launch

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Myc. Cure Complete cure Visual improvement

24W 52W 52W 4W

MOB-015Target

>50% 60-70% 20-30% >50%

Jublia - 54% 15-18% N/A

Current OTCs* Ca 30% 6-8% or less N/A

Superior Cure Rates

Rapid Visible Improvement

Potential for Shorter Treatment* Refers to ciclopirox and amorolfine. Most OTC products have not conducted full 52w trials

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Phase 3 program for MOB015

• EU study with active comparator arm (N=400)

• North American study with vehicle comparison (N=350)

• 48 weeks treatment + 4 weeks F/U

• Primary endpoint: Complete Cure

• Meetings held: FDA (USA) pre-IND, BfArM (DE), MHRA (UK), MPA (SWE)

• IND/Phase 3 applications approved by FDA, Health Canada, BfArM (DE), and Polish regulator

• Expected Rx Markets: US, Canada & Japan

• Expected OTC markets: Remaining, some may require limited post-MA usage before OTC

Regulatory

Enrollment to twophase 3 started in September 2016

Deal opportunity and structureMOB-015

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• Moberg Pharma will provide exclusive rights to MOB015 to partners with strong commercialization capabilities

• Moberg Pharma finances the two Phase 3 trials Co-development/Co-marketing could be considered for certain territories.

• Manufacturing at Moberg’s CMO in Germany

• Deal structure:

– Upfront payment at signing

– Development and regulatory milestones

– Transfer price on finished product

– Supply agreement

• Initial feedback should clarify territory (-ies) of interest

BUPI

Product & Indication• Lozenge formulation of bupivacaine for providing

oral pain relief (mouth and throat)• First indication is pain due to Oral Mucositis (OM)

in cancer patients. Large market potential.• Other indications/syndromes where a local

anesthetic effect is desired are potential uses, incl.– Burning Mouth syndrome, – Sjögren’s syndrome, – Procedures such as upper gastrointestinal

endoscopy.

– Dental applications– Other oral pain OTC indications (longer term)

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BUPI - Providing better pain relief in the oral cavity

Status and Next steps• Phase 2 completed

• Phase 3 in preparation on Oral Mucositis in cancer patients

Note: Several scoring system exist, but the WHO scale is the most frequently used (as shown above)

• There is a high unmet medical need in providing pain relief for patients with Oral Mucositis. It is advantageous to treat the pain locally rather than systemically due to fewer side effects.

• Peak Sales potential estimated to $50-100m (whereof OM $20-25m)

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BUPI – Oral Mucositis as first indication

Unmet medical need

High incidence of mucositis in cancer patients

• Very common side effect of cancer treatment with chemo/radiotherapy

– Radiotherapy for head and neck cancer: 85-100% of which 25-45% are grade 3-4

– Stem-cell transplantation: 75-100% of which 25-60% are grade 3-4

– Solid tumors with myelosuppression: 5-40% of which 5-15% are grade 3-4

• Oral Mucositis is caused by damage of the mucosa in the oral cavity and the pharynx, which induces severe oral pain and swallowing problems.

• Oral Mucositis has been identified by patients as the most debilitating adverse effect associated with their cancer treatment as it induces severe problems with eating, drinking and speaking.

• Presently no effective pain treatment without considerable side effects exists.

USP: ” BUPI provides longer and better oral pain relief” Target product profile

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• Self administration on an “as-needed” basis: 1 lozenge every 3 hours when required for pain relief

• Rapid onset of action (within minutes),

• Provides up to 3 hours of pain relief (clinically significant downward shift on VAS pain scale)

• Stimulates salivation ( patients at risk of xerostomia)

• Easy to use to improve compliance (in self-care setting)

• Safe (no systemic mode of action, no significant side effects)

• Can be made available in several different flavors; i.e. liquorice, menthol…

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Proven bupivacaine in a new topical form

An innovative patented lozenge

Patents

A well known molecule

• Bupivacaine is a local anaesthetic of the amide type which has been used in many licensed medicinal products for years, including epidural infusions and solutions for injections.

• The mode of action and pharmacological properties of local anaesthetics including bupivacaine are well established.

• Substantial data and information on efficacy and general safety of bupivacaine is widely available in the literature.

• BUPI is a compressed tablet with a target weight of 800 mg containing bupivacaine hydrochloride corresponding to 25 mg bupivacaine

• Patent granted in Europe (Patent No. 2701681)– The new patent covers 1) pharmaceutical compositions comprising a local anesthetic, such as

bupivacaine, for local administration to the mouth or throat and 2) lozenge formulations of a local anesthetic for use in the treatment of oral mucositis in cancer patients. This patent is expected to provide coverage through at least 2031.

• Patent process ongoing in US and Canada.

• An open, randomized, controlled study, where head and neck cancer patients with OM were followed for 7 days after they had scored pain of ≥ 40mm on a visual analogue scale (VAS) in oral cavity or pharynx.

– Treatment group: Bupivacaine lozenges 25 mg + systemic pain therapy as needed. One lozenge every twohours, maximum 8 lozenges per day or,

– Control group: Standard pain therapy consisting of lidocaine viscous oral gel + systemic pain therapy as needed

• Efficacy

– Primary endpoint:

• Average of the highest VAS scores in the mouth or pharynx measured 60 minutes after administration of a bupivacaine lozenge for the patients in the lozenge group and the highest VAS scores in the mouth or pharynx measured every two hours for the patients in the control group.

– Secondary endpoints

• Morphine consumption, various VAS pain assessments in mouth and pharynx before/after administration

• Safety

– Adverse events

– Plasma concentrations of bupivacaine ( 10 patients)

• In total 39 head and neck cancer patients completed the study

Design

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Phase 2 Randomized Controlled Trial

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Phase 2 – Significantly lower pain levels in BUPI group

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10

20

30

40

50

60

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BUPI Control

baseline average max VAS

• Primary endpoint: 31% less pain in BUPI group (Highest VAS score in mouth/pharynx, p=0,0032)• In Mouth only: 50% less pain in BUPI group (p=0,0002)

0

5

10

15

20

25

30

35

40

BUPI Control

baseline average max VAS

VAS Score (Highest of Mouth/Pharynx) VAS Score in Mouth only

Primary endpoint

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Phase 2 – Rapid and significant pain relief

Source: Poster presentation at International Association for the Study of Pain (IASP), Japan, September 2016.

Efficacy

• Statistically significant difference in pain, 60 minutes after dosing, compared to standard treatment

– Mouth or pharynx : 31% less pain in BUPI group ( highest VAS score 35mm vs 51mm for control group, p=0,0032)

– Mouth : 50% less pain in BUPI group (VAS score 18mm vs 36mm for control group, p=0,0002)

– Pharynx : trend but not statistically significant (VAS score BUPI 37mm vs 48mm for control group, p=0,0630)

• Effect shown in both the mouth and throat

• Statistically significant difference in pain (intake of lozenge next dose) compared to standard treatment. On average, patients used 3-4 lozenges per day.

• Treatment with BUPI did not affect need for morphine

Safety

• No serious adverse reactions associated with BUPI

• Plasma concentrations of bupivacaine below toxic levels

• 2 patients withdrew due to treatment related adverse events (pain/stinging in mouth)

Phase 2 - Summary of results

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Phase 3 and Regulatory

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Phase 3 program to serve worldwide registration

• Open, multicenter, randomized, controlled study in Europe

• Local pain management in head and neck cancer patients with oral mucositis

• Approximately 150 patients

• First patient inclusion in Q2 2017, study completion Q3 2018

• Second Phase 3 study with similar design to be conducted in India by Cadila

• Expected Rx status in most territories

• Scientific Advice Meetings EU Q1 2017

• Evaluate PIP plan Q1 2017

• EU registration Q4 2019

• Submit US Orphan Drug application Q2 2017

Regulatory

Two Phase 3 studies to start in Q2 2017

Licensing & Next Steps

Deal opportunity and structureBUPI

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• Moberg Pharma will provide exclusive rights to BUPI to partners with strong commercialization and development capabilities

• Two Phase 3 trials are financed by Moberg and a partner.

• Manufacturing established at Moberg’s CMO and at Cadila

• Licensing Deal structure:

– Upfront payment at signing

– Development and regulatory milestones

– Transfer Price/Royalties on end-sales

– Supply agreement – subject to deal structure/negotiations

• Initial feedback should clarify territory (-ies) of interest

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Contacts

Peter Wolpert, CEO

+46 8 522 307 08, peter.wolpert@mobergpharma.se

Francis Lambert, Business Development Director

+46 8 522 807 42, francis.lambert@mobergpharma.se

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Moberg Pharma AB (Publ)Gustavslundsvägen 42, 5 tr.

167 51 Bromma

mobergpharma.se