Reports
Publicerat: 2019-11-08 08:15:00
2019 THIRD QUARTER (Jul-Sep) FIRST NINE MONTHS 2019 (Jan-Sep)
From the CEO The third quarter can be described as a period of activities and events to continue building the foundation of the future Peptonic. Many long-term investments being made now are expected to pay off in the future i.e. in a few months up to a few years from now. Our vision is to develop a product portfolio with focus on women’s health and well-being. The products need to have a proven treatment effect – and this shall also apply to Peptonic’s self-care products under the banner: ‘evidence to the self-care section’. This is how Peptonic’s products will differ from competing products in this segment. The home market is important from a reference and source of experiences point of view i.e. what works well and what doesn’t work so well in the marketing of VagiVital. Clearly, we want to achieve high market shares in Sweden, but sales on other markets will be essential for the future growth of Peptonic. Hence, it is important to start selling in countries outside Sweden as soon as possible. In some countries we will appoint local distributors whereas in other countries we have decided to open our own web shops. The latter is the fastest way of entering many of the larger markets to start selling. This with the intention to expand distribution to local pharmacies or other channels /retail shops to improve the accessibility of the product as soon as possible. This is the model we have already implemented in Norway and Denmark in September and in the UK in October this year. We are also opening a web shop in Hong Kong in the near future. In Finland, Orion Pharma launched VagiVital in April under the trademark Femisan Vital. The product is sold via pharmacies and the uptake has been very good so far. Since launch, the monthly sales volume has been higher than in Sweden. An instant access to the pharmacies across the country and the deployment of a specialised sales force focusing exclusively on pharmacies would explain the successful launch. Of course, satisfied customers also contribute. Orion Pharma has ordered a new batch of product, which will be delivered before end of the year. During the period, we have informed about two distribution agreements and two launches via on-line web shops. The distribution agreement with Yuanjia Bio for PR China in July is a great success with great potential. Yuanjia Bio has initiated the registration process of VagiVital. However, it’s not clear as to how long a procedure this is, but the aim is to launch VagiVital during 2021. Initially, Yuanjia Bio will detail hospital gynaecologists through its sales force with the aim of expanding marketing to consumers at a later stage. This, however, depends on the regulatory classification of the product. The agreement with Adexilis covering Hungary, Slovakia and Croatia was signed in August. Preparations for the launch are under way and launch is expected to occur during H1 2020. Marketing and promotion of VagiVital in different media is costly, but necessary. However, by joint campaigns with the pharmacy chains and by well targeted and well timed campaigns in social media and TV, we have been able to contain costs at a reasonable level. During the first quarter of 2020, we will hire a sales force to visit and educate personnel at pharmacy retail shops carrying VagiVital. After this, we will evaluate the outcome and decide whether to continue or not. We have also increased our internal resources by the recruitment of a product manager. Her name is Nikolina Spolén and she was with Kronans Apotek for five years before joining Peptonic. Sales in Sweden is growing. The trend shows increased market sales volumes month by month. In Norway and Denmark the advertsing in social media has started. Sales volumes are still modest, but with increased advertising volumes will grow. The financial status of the company is good. Revenues increased by circa 51% compared to the previous quarter. Gross margin has decreased during the period as compared to previous quarters. This can be explained by the initial pre-payment by Yuanjia Bio in connection with the signing of the distribution agreement. Since transfer price for China is lower than that for Sweden and Finland, gross margin will decrease. This, of course, shall be compensated by much larger volumes with time. Also, during 2018, VagiVital was sold almost entirely through the on-line web shop, which means a higher gross margin. With the threat of a hard Brexit in the spring, we decided to change our Notified Body in England to one located in another EU country. We signed up with DQS Medizintechnik GmbH in June and the work with transferring the CE certification started. In September, we informed the market of the completed transfer and a renewed CE certification. This is valid until May 2024. Hence, we are well positioned to continue the roll out of VagiVital in the EU without the threat of regulatory obstacles. Before May 2024, the certificate has to be renewed according to the new European legislation. This legislation means much tougher requirements e.g. for clinical documentation of efficacy. Here VagiVital is well positioned and we estimate many of the competing products of today to disappear due to poor clinical documentation to support claims. We continue our efforts to expand the product portfolio. We are evaluating a number of interesting products and product concepts within the field of vaginal/intimate health. This to be able to capitalise on synergies with VagiVital both concerning the brand and concerning its target customer groups. Having said this, we can expect an interesting news flow during the next coming months. Johan Inborr CEO Stockholm, November 8th, 2019 IMPORTANT EVENTS DURING THE PERIOD IMPORTANT EVENTS AFTER THE END OF THE PERIOD FINANCIAL INFORMATION Costs – Costs for the third quarter were KSEK -5,684 (-3,540). The costs that have significantly increased during the quarter are costs of sold goods and the launch costs. Costs for the nine first months were KSEK -13,047 (-9,808). During the period costs of products were KSEK 1,752 and launch costs KSEK 6,587. Result – Loss before tax for the third quarter was KSEK -4,130 (-3,461). For the first nine months the loss was KSEK -13,047 (-9,808). During the period an interest-bearing loan of KSEK 10,500 incurred an interest cost of KSEK -630. The loan was repaid before the end of the half year. Equity - The company"s equity as of September 30, 2019 amounted to KSEK 75,175 (60,384), which gives a solvency ratio of 96 (93) percent. Liabilities - As of September 30, 2019, the company"s liabilities amounted to KSEK 2,988 (4,864). At year-end, the level was KSEK 13,910, the major difference being the repayment of the bridge loan of KSEK 10,500. Organization - During the period, the average number of employees was 2 (2). At the end of the period, the number of employees was 3 (2). In addition to this, from 2018 there is a marketing manager and a quality manager hired as consultants, furthermore the accounting is posted at an accounting firm. Share - The total number of shares as of September 30, 2019 was 127,128,306 (86,028,600). This interim report has not been reviewed by the Company’s auditors. The Board of Directors and the CEO certifies that the interim report gives a fair overview of the business, position and profit or loss of the Company. FINANCIAL CALENDER Year end report, 2019 February 27th 2020 Stockholm, November 8th, 2019 Hans von Celsing, Chairman 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 Mobile: +46 708 853 893 E-mail: johan.inborr@peptonicmedical.se 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 8 November 2019. 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 and has since then also been launched in Finland, Denmark, Norway and the United Kingdom (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 holds 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.spotlightstockmarket.com, ticker: PMED) in Stockholm, Sweden. For more information:www.peptonicmedical.com
Net sales – Net Sales of products for the third quarter were KSEK 1,557 (120). Other income for the first quarter were KSEK 0 (0). Net Sales of products for the first nine months were KSEK 4,073 (120), other income were KSEK 0 (66).
Financial position and liquidity – Liquid assets were KSEK 19,642 (6,005) as of September 30, 2019. During the first nine months the company received a net SEK 8,609 (0) in newly issued capital through the agreement with ReCall Capital on lending of shares and directed new issues. The cost of this has been about 6% of issued capital. In June, a major rights issue was also carried out, which resulted in net proceeds of SEK 24,362 at a cost of about 6.6%.
INCOME STATMENT
3 months
3 months
9 months
9 months
12 months
Jul-Sep
Jul-Sep
Jan-Sep
Jan-Sep
Jan-Dec
KSEK
Note
2019
2018
2019
2018
2018
Operating income
Sales of products
1,557
120
4,073
120
383
Other operating income
0
0
0
66
86
Total operating income
1,557
120
4,073
186
469
Operating expenses
Cost of goods
-841
-25
-1,752
-25
-150
Other external expenses
1
-3,544
-2,673
-11,239
-6,471
-9,544
Personnel costs
-1,299
-823
-3,496
-3,372
-4,471
DepreciationOther operating costs
-00
-190
-00
-570
-76-609
Total operating expensses
-5,684
-3,540
-16,487
-9,925
-14,850
Operating loss
-4,127
-3,420
-12,414
-9,739
-14,381
Net financial income/expense
-3
-41
-633
-69
-560
Loss before taxes
-4,130
-3,461
-13,047
-9,808
-14,941
Taxes
-
-
-
-
-
Net loss for the period
-4,130
-3,461
-13,047
-9,808
-14,941
BALANCE SHEET
Sep 30
Sep 30
Dec 31
KSEK
Note
2019
2018
2010
Assets
Non-Current assets
Intangible assets
2
56,836
58,069
56,396
Tangible assets
0
0
0
Financial assets
-
-
-
Total non-current assets
56,836
58,069
56,396
Current assets
Stock
679
525
609
Other receivbles
768
474
587
Tax receivable
-
-
-
Prepaid expenses and accrued income
238
175
204
Liquid assets
19,642
6,005
11,365
Total current assets
21,327
7,179
12,765
Total assets
78,163
65,248
69,161
Equity and liabilites
Equity
Ristricted equity
Share capital
12,713
8,603
8,603
Ongoing right issues
-
-
-
Development Cost Fund
14,538
14,124
14,538
Non- restrictes equity
Share premiun reserv non-restricted
161,105
132,744
132,244
Profit or loss brought forward
-100,134
-84,779
-85,193
Net loss for the period
-13,047
-9,808
-14,941
Total equity
75,175
60,384
55,251
Current liabilites
Trade payables
938
1,366
1,607
Interest bearing loans
0
0
10,500
Other payables
252
60
319
Prepaid income and accrued expenses
1,798
3,4388
1,484
Total current liabilites
2,988
4,864
13,910
Total equity and liabilities
3
78,163
65,248
69,161
KEY FIGURES
9 months
9 months
12 months
Jan-Sep 2019
Jan-Sep 2018
Jan-Dec 2018
Revenues, KSEK
4,073
120
383
Gross profit sales goods, KSEK
2,321
95
233
Gross margin, %
57%
79%
61%
Operating profit, KSEK
-12,414
-9,739
-14,381
Return on equity, %
-27
-22
-26
Equity ratio, %
96
93
80
Earnings per share, SEK
-0.10
-0.11
-0.17
Liquidity per share, SEK
0.15
0.07
0.13
Equity per share, SEK
0.59
0.70
0.64
Share price per closing, SEK
2.050
0.820
0.500
Share price/Shareholders’ equity per share, SEK
3.47
0.75
1.08
Number of issued shares at the end of the period
127,128,306
86,028,600
86,028,600