Year End Report

Period from January to December 2018

Peptonic Medical AB (publ) org nr 556776-3064

(www.aktietorget.se,  ticker: PMED)

2018 FOURTH QUARTER (Oct-Dec)

• Net sales of products KSEK 263 (0)
• Gross profit KSEK 137 (0), Gross margin 52% (0%)
• Incoming purchase orders KSEK 1 431 (0)
• Operating loss KSEK -4,572 (-4,753) 

• Loss per share SEK -0.06 (-0.11)

FULL YEAR 2018 (Jan-Dec)

• Net sales of products KSEK 383 (0)
• Gross profit KSEK 232 (0), Gross margin 61% (0%)
• Incoming purchase orders KSEK 1 551 (0)
• Operating loss KSEK 14,311 (-12,962)

• Loss per share SEK -0.17 (-0.30)

From the CEO

The year started with full focus on obtaining the CE mark and on the preparations for the launch of VagiVital. The CE mark was awarded the product in May and already in July VagiVital was launched via its own webshop (www.vagivital.com). The reception of the product was better than we could have hoped for. Feedback from the customers has been very positive. This was confirmed in a customer survey in December. Among those women that had used VagiVital for more than two months, 89 percent reported significant symptom relief. These results are well in line with those obtained in the clinical study, which is very satisfying.

Thanks to a well executed marketing campaign, the interest for VagiVital among the pharmacy chains and on-line purchasing sites has grown quickly. Today VagiVital can be purchased from the following outlets/sites: Apoteket AB’s thirty largest retail shops across Sweden and its webshop, Apoteket Hjärtat’s webshop, Apoteksgruppen’s forty franchise pharmacies (on order), Apotea.se, Apohem.se, Apotek365.se, Meds.se, iApotek.se och Netoteket.se. The work to further broaden the distribution continues with highest priority.

In June, an agreement was signed with Orion Pharma concerning the distribution of VagiVital in Finland. The product will be marketed under Orion Pharma’s trademark Femisan Vital. In October, Peptonic received the first product order from Orion Pharma. The launch has been delayed due to strategic considerations, but it will soon happen. The order will be delivered to Orion during the first quarter 2019.

To secure distribution of VagiVital in other markets is of high importance to us. Hence, we have increased our business development resources to find distributors. Due to the CE mark, our main focus is on Europe, but other markets are of course of interest, too. One such market is USA for which a 510k registration is required. The process of obtaining the 510k registration has started and all required documentation is expected to be submitted by end of 2019. The US vaginal atrophy/dryness market is dominated by hormone-based products and is estimated to over 1.3 billion Euros. The majority of women suffering from these symptoms are looking for hormone-free treatments (Peptonic/TEFEN, 2016). Currently, we are in discussions with a number of distributor candidates and hope to close a few deals by the end of this year. The successful launch and our experiences from the Swedish market are very useful in these discussions.

One particular patient group with a high incidence and prevalence of vaginal atrophy are women that have undergone cancer treatment and are taking post treatment aromatase inhibitors. These women are contraindicated for treatment with hormones, such as estrogen. Here VagiVital® offers an excellent hormone-free alternative. To confirm this and to increase the awareness of VagiVital® among health care providers, a prospective clinical study will be performed with this patient group. Preparations are well under way and we expect the first patient to enter the study in April this year. Results of the study are expected during Q1 2020.

Marketing and promotion require capital. This has been obtained through a rights issue in June and through a so called ‘on tap’ financing arrangement with Recall Capital. The rights issue (with preferential rights) was over-subscribed and resulted in a 10 MSEK injection (after costs). The ‘on tap’ financing arrangement means that Recall Capital borrows shares from Peptonic shareholders. The shares are then sold on the market and the proceeds are transferred to Peptonic. Recall Capital will then be issued the same number of shares by means of a directed rights issue. This model is a relatively inexpensive way of financing and has generated proceeds of 2.7 MSEK during 2019 so far. The company intends to use this financing option also during the current year. In addition to the capital raised as described above, the company also obtained a bridging loan from Formue Nord of 10.5 MSEK, the loan is to be repaid latest by July 31st2019. Thanks to the above capital injections our cash position is solid and means that we can go forward according to our marketing and development plans.

Operating profit of the year was -14.3 MSEK. Product sales were 469 TSEK (exclusive of the Orion Pharma order). Marketing, manufacturing, transport and distribution costs have increased considerably in 2018, not surprisingly, and were 4.0 MSEK. Costs of obtaining the CE mark, implementing the ISO quality system and scaling up manufacturing were 2.8 MSEK. Immaterial assets were reduced by 1.2 MSEK (from 57.6 MSEK to 56.4 MSEK) on the balance sheet.

Our ambition is to continue developing Peptonic to become a fully fledged women’s health company by offering additional products backed by clinical evidence of efficacy. This can be achieved either through in-house development, in-licensing or distributorships. We are in discussions with a number of companies with the aim of launching new products on the Nordic market.

Having said all this, I can conclude that Peptonic is in an exciting development stage, and the current year will be at least as exciting as last year. I want to express my sincere gratitude to the shareholders, to the Board members and advisors for all support and trust. I also want to thank my close colleagues for their massively valuable efforts during the year.

Stockholm, February 27th, 2019

Johan Inborr

CEO, Peptonic Medical

FINANCIAL INFORMATION

Net sales – Net Sales of products for the fourth quarter were KSEK 263 (0). Net sales of products for the full year were KSEK 383 (0). Other income for the fourth quarter were KSEK 20 (169) and for full year KSEK 86 (169).

Costs – Costs for the fourth quarter were KSEK -4,855 (-4,922). Costs for the full year were KSEK

-14,871 (-13,131).

Result – Loss before tax for the fourth quarter was KSEK -5,063 (-4,730). Loss before tax for the full year was KSEK -14,871 (-12,973).

Financial position and liquidity – Liquid assets were KSEK 11,365 (7,054) as of December 31, 2018. During the full year the company received KSEK 10,898 (11,024) in new share issues. The company did also take a bridge loan on KSEK 10,500 (0).

Equity – PEPTONIC medical AB´s equity amounted to KSEK 55,321 (59,694) as of December 31, 2018, resulting in a solidity of 80 (91) percent.

Organization – The average number of employees during the period was 2 (2). At the end of the year the number of employees was 2 (2).

Share – Total numbers of shares in the company amounted to 86,028,600 as of December 31, 2018.

NOTE

Accounting principles 

This interim report has been prepared in accordance with the Annual Accounts Act (Chapter 9. Interim Report) and the Swedish Accounting Standards Board’s general advice, BFNAR 2012:1 Annual Report and consolidated (K3-rules).

Note 1 – Related-party transactions

During the year companies represented by members of the Board of Directors have been contracted as consultants. Total compensation for consultancy services amounted to KSEK 125 (996) excl. of VAT, and is mainly related to Business Development services. All transactions between related parties are based on market conditions. No other key executives or their immediate family members have been directly or indirectly involved in any business transaction with the Company that is or was unusual in its character or terms and conditions during the year.

Note 2 – Intangible assets

Capitalized patent and development costs are estimated to result in future revenues for the company. Patent and development costs are stated at acquisition value in the balance sheets.

Note 3 – Equity and liabilites

Interest-bearing liabilities amount to KSEK 10,500 (0). A bridge loan was raised in the fourth quarter of 2018. The loan has to be paid back in July 2019. The Danish asset management firm Formue Nord was the lender.

Dividend

The Board of Directors proposes that no dividend is paid for the fiscal year 2018.

Annual Report 

Complete Annual Report for 2018 can be ordered from the company’s office or be downloaded from the webpage from the date of 18th of April 2019. It will be written in Swedish.

Annual General Meeting 

The AGM will be held in Stockholm on the 19th of June 2019.

This interim report has not been reviewed by the Company’s auditors.  

The Board of Directors and the CEO certify that the interim report gives a fair overview of the business, position and profit or loss of the Company.

FINANCIAL CALENDER

Annual report 2018                                                                                                                      April 18th 2019

Quarterly report, 1                                                                                                                       May 15th 2019

Quarterly report, 2                                                                                                                        August 16th 2019

Quarterly report, 3                                                                                                                        November 8th 2019

Year end report, 2019                                                                                                                  February 27th 2020

Stockholm, February 27th, 2019

Hans von Celsing, Chairman of the Board                                                   Arne Ferstad, Board member

Marianne Östlund, Board member                                                               Leni Ekendahl, Board member

Johan Inborr, CEO

Note: This document has been prepared in both Swedish and English. The Swedish version shall govern in case of differences between the two documents. The document contains certain statements about the Company’s operating environment and future performance. These statements should only be regarded as reflective of prevailing interpretations. No guarantees can be made that these statements are free from errors.

This information is information that Peptonic Medical 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 person set out above, at 27th February 2019.

Johan Inborr, CEO

Mobile: + 46 708 853 893

E-mail: johan.inborr@peptonicmedical.se

About VagiVital®

VagiVital®is a patent pending hormone free self-care product for the treatment of vaginal atrophy and vaginal dryness. The product has been tested in randomised clinical studies (vaginal atrophy) with very positive results both for objective (vaginal pH and proportion of superficial cells in the vaginal mucosa) and subjective (most bothersome symptoms, such as vaginal dryness, vaginal irritation/itching, dyspareunia and dysuria) parameters. The magnitude of symptom relief is on par with that demonstrated with e.g. prescription estrogen based products on the market today. It was very well tolerated and caused no serious adverse effects. 

VagiVital®was launched in Sweden as a non-prescription self-care product in July 2018 (see www.vagivital.com). 

About Peptonic Medical

Peptonic Medical is an innovative Swedish medical development company. Its vision is to offer safe and effective treatments and relief for women specific diseases and medical conditions.

VagiVital®is a registered trademark of Peptonic Medical. The product is hormone free and is being commercialised for the non-prescription use for the treatment of vaginal atrophy (VA) and vaginal dryness. The pipeline of Peptonic Medical also includes Vagitocin®, which is an oxytocin-based vaginal gel for the treatment of VA. This product candidate is in clinical development phase 2. The development of Vagitocin® is on hold pending additional data on i.a. the mechanism of action.

Since July 2014, the Peptonic Medical share has been traded on the Spotlight Stock Exchange (www.spotlight.se, ticker: PMED) in Stockholm, Sweden. 

For more information:www.peptonicmedical.com