YEAR END REPORT
Period from January to December 2017
Peptonic Medical AB (publ) org nr 556776-3064
(www.aktietorget.se, ticker: PMED)
2017 FOURTH QUARTER (Oct-Dec)
FULL YEAR 2017 (Jan-Dec)
IMPORTANT EVENTS DURING THE PERIOD
IMPORTANT EVENTS AFTER THE END OF THE PERIOD
From the CEO
The outcome of the clinical phase 2b study that ended in March 2017 lead to a change of the Company’s product strategy. Because the preset clinical endpoints weren’t achieved, the road to a registration of a product based on oxytocin was closed. But instead, a new avenue towards a product launch was opened. Namely, the data from the clinical study showed a surprisingly good treatment effect of the placebo gel (no oxytocin) on the symptoms associated with Vaginal Atrophy. Based on these strong results, the Board of Peptonic Medical decided to change the product strategy of the company and launch the oxytocin-free gel as a non-prescription self care product under the tradename VagiVital®.
To launch VagiVital® it has to be CE –marked. The work to obtain the CE mark started without delay in May with the aim of being completed by the end of Q1 2018. So far, the work has progressed entirely according to plan and all required documents and material have been submitted to the Notified Body for final review and approval.
The preparations for the launch of VagiVital® are now well underway. A technology transfer agreement has been signed with Orion Corporation (Finland) for the manufacture of the product. Orion Corporation is a competent and experienced manufacturer of pharmaceutical and self care products. We consider the terms of the agreement to be very competitive and we can expect to have a product of highest quality for the market.
In connection with starting the CE mark project, a rights issue was launched in May/June. This rights issue with preferential rights was over-subscribed and rendered in proceeds of 12.3 MSEK before issue costs. In addition, the Board exercised a proxy for an additional rights issue, which brought an additional 1.1 MSEK to the company. The proceeds of these rights issues shall be used for obtaining the CE mark and for the preparations of the launch of VagiVital®. So far, we have managed to keep expenditure well within the budget, which resulted in more cash in bank than expected by the end of the year. We will of course continue to keep close control of our expenses and use our capital wisely.
Loss for the year was 12.9 MSEK. This must be regarded as a good financial outcome and proof of controlled cost containment considering that a large clinical study (with over 200 randomised patients) was conducted. In the balance sheet this year, we have made depreciations for patents and balanced development costs related to patents for which we do not see a commercial potential.
With the launch of VagiVital® in 2018, this year will be an exciting and historical year for Peptonic Medical. We also have our eyes on markets outside Sweden and discussions are underway with potential partners and distributors. A successful launch in Sweden will clearly be beneficial for going forward with these discussions.
I want to take this opportunity to thank the shareholders, the Board, the clinical study investigators and suppliers for your support and trust, and my closest staff for their invaluable contributions during the year.
Stockholm, February 27th, 2018
VD, Peptonic Medical AB
Peptonic Medical AB (publ) is an innovative Swedish biopharma company developing medicinal products within the field of Women’s Health. Our vision is to offer safe and effective treatments to women suffering from women specific diseases and conditions. The Company’s first product - VagiVital® - has been developed for the treatment of Vaginal Atrophy (VA), a disease affecting approximately fifty per cent of women in menopause and after. VagiVital® is a trademark of Peptonic Medical.
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.
In July 2014, Peptonic Medical was listed on the AktieTorget stock exchange (www.aktietorget.se, ticker: PMED) in Stockholm.
For more information: www.peptonicmedical.com
VagiVital® is a 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. estrogen based products on the market today. It was very well tolerated and caused no serious adverse effects.
PEPTONIC Medical plans to launch VagiVital® as a non-prescription self-care product in 2018.
Net sales – During the fourth quarter the Company recorded sales (other income) of KSEK 169 (0). Other income for the full year were KSEK 169 (0).
Costs – Costs for the fourth quarter were KSEK -4,922 (-3,016). Costs for the full year were KSEK
Result – Loss before tax for the fourth quarter was KSEK -4,730 (-2,964). Loss before tax for the full year was KSEK -12,973 (-11,258).
Financial position and liquidity – Liquid assets was KSEK 7,054 (12,169) as of December 31, 2017. During the full year the company received KSEK 11,024 (5,386) in new share issues.
Equity – PEPTONIC medical AB´s equity amounted to KSEK 59,694 (61,643) as of December 31, 2017, resulting in a solidity of 91 (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 43,014,300 as of December 31, 2017.INCOME STATMENT 3 months 3 months 12 months 12 months Oct-Dec Oct-Dec Jan-Dec Jan-Dec KSEK Note 2017 2016 2017 2016 Operating income Other operating income 169 - 169 - Total operating income 169 - 169 - Operating expenses Other external expenses 1 -1,514 -973 -6,029 -5,709 Personnel costs -1,170 -982 -4,854 -4,541 Depreciation -76 -3 -86 -12 Other operating costs -2,162 -1,058 -2,162 -1,058 Total operating expensses -4,922 -3,016 -13,131 -11,320 Operating loss -4,753 -3,016 -12,962 -11,320 Net financial income/expense 23 52 -11 62 Loss before taxes -4,730 -2,964 -12,973 -11,258 Taxes - - - - Net loss for the period -4,730 -2,964 -12,973 -11,258 BALANCE SHEET Dec 31 Dec 31 KSEK Note 2017 2016 Assets Non-Current assets Intangeble assets 2 57 604 54,995 Tangeble assets 0 10 Financial assets - - Total non-current assets 57,604 55,005 Current assets Raw materials and consumables - - Other receivbles 467 649 Tax receivable - - Prepaid expenses and accrued income 258 111 Liquid assets 7,054 12,169 Total current assets 7,779 12,929 Total assets 65,383 67,934 Equity and liabilites Equity Ristricted equity Share capital 4,301 2,060 Ongoing right issues 0 0 Development Cost Fund 14,033 9,767 Non- restrictes equity Share premium reserv non-restricted 126,048 117,265 Profit or loss brought forward -71,715 -56,191 Net loss for the period -12,973 -11,258 Total equity 59,694 61,643 Current liabilites Trade payables 683 1,708 Other payables 442 434 Prepaid income and accrued expenses 4,564 4,149 Total current liabilites 5,689 6,291 Total equity and liabilities 3 65,383 67 934
STATMENT OF CASH FLOW
CASH FLOW FROM OPERATIONS BEFORE CHANGES IN WORKING CAPITAL
Non-cash flow items
NET CASH FLOW FROM OPERATING ACTIVITIES BEFORE CHANGES IN WORKING CAPITAL
Increase (-) decrease (+) inventory
Increase (-) decrease (+) receivables
Increase (-) decrease (+) liabilities
NET CASH FLOW FROM OPERATING ACTIVITIES
CASH FLOW FROM INVESTING ACTIVITIES
Investment in immaterial and material assets, net
Investment in financial assets
Divestment / reduction of financial assets
NET CASH FLOW FROM INVESTING ACTIVITIES
CASH FLOW FROM FINANCING ACTIVITIES
NET CASH FLOW FROM FINANCING ACTIVITIES
TOTAL CASH FLOW FOR THE YEAR
Cash and cash equivalents at beginning of period
CASH AND CASH EQUIVALENTS AT END OF THE YEAR
CHANGES IN EQUITY
Develop-ment cost fund
Ongoing right issue
Share Premium reserven-rest
Total shareholders equity
Opening balance January 1, 2016
Net loss for the year
Transfering fundRegistered rights last year
Closing balance December 31, 2016
Opening balance January 1, 2017
Net loss for the year
Transfering fundRight issue
Closing balance December 31, 2017
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 996 (1,340) excl. of VAT, and is mainly related to R&D and 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.2017 2016 KSEK Jan-Dec Jan-Dec Consulting fees Board of Directors 996 1,340 Total 996 1,340
Note 2 – Intangible assets
Patents and development costs are capitalized and amortized over five years after the first income has been acquired. 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.Dec 31 Dec 31 Capitalized development costs 2017 2016 Accumulated acquisition value Opening balance 47,659 37,892 Sold out and Other disposals -1,965 0 Capitalizations during the period 4,414 9,767 50,108 47,659 No depreciation has been made as no income has been acquired - - Net booked amount at end of year 50,108 47,659 Patents och licenses Accumulated acquisition value Opening balance 7,336 7,515 Sold out and Other disposals -197 -1,058 Capitalizations during the period 433 879 7,572 7,336 Depreciation - closed down of patent families, because of short of time to end of patent -76 0 Net booked amount at end of period 7,496 7,336 Total intangible assets 57,604 54,995
Note 3 – Equity and liabilites
All of the Company’s debts are non-interest bearing.KEY FIGURES 12 months 12 months Jan-Dec Jan-Dec 2017 2016 Operating loss, KSEK -12,962 -11,320 Return on equity, % -21.4 -17.4 Solidity, % 91 91 Earnings per share, SEK -0.3 -0.6 Liquid assets per share, SEK 0.2 0.6 Shareholders’ equity per share , SEK 1.39 2.99 Share price per closing, SEK 0.635 6.45 Share price/Shareholders’ equity per share,SEK 0.46 2.16 Number of share per closing 43,014,300 20,602,984
The Board of Directors proposes that no dividend is paid for the fiscal year 2017.
Complete Annual Report for 2017 can be ordered from the company’s office or be downloaded from the webpage from the date of 7th of March 2018. It will be written in Swedish.
Annual General Meeting
The AGM will be held in Stockholm on the 28th of March 2018.
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.
Annual report 2017 March 7th 2018
Quarterly report, 1 May 15th 2018
Quarterly report, 2 August 17th 2018
Quarterly report, 3 November 9th 2018
Year end report, 2017 February 27th 2019
Stockholm, February 27th, 2018
Hans von Celsing, Chairmen of the Board Arne Ferstad, Board member
Marianne Östlund, Board member Leni Ekendahl, Board member
Johan Inborr, CEO
For more information please contact:
Johan Inborr, CEO PEPTONIC medical AB. Phone: +46 708 853 893
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 2018.