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Moberg Pharma — Interim / Quarterly Report 2015
Aug 11, 2015
3174_ir_2015-08-11_667bb570-0696-44c3-a1f7-5729fdce131b.pdf
Interim / Quarterly Report
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CONTINUED SEQUENTIAL GROWTH
"Strong performance across the board, including launches in Asia as a key driver, resulted in a second quarter with excellent topline growth and improved profitability," comments Peter Wolpert, CEO Moberg Pharma
FIRST SIX MONTHS (JAN-JUN 2015)*
- Revenue MSEK 165.3 (105.5)
- EBITDA MSEK 28.5 (14.4)
- EBITDA for Commercial Operations MSEK 41.9 (22.6)
- Operating profit (EBIT) MSEK 23.2 (10.5)
- Net profit after tax MSEK 16.4 (8.1)
- Earnings per share SEK 1.13 (0.67)
- Operating cash flow per share SEK 1.20 (0.28)
SECOND QUARTER (APR-JUN 2015)*
- Revenue MSEK 92.2 (57.7)
- EBITDA MSEK 11.1 (6.9)
- EBITDA for Commercial Operations MSEK 16.3 (10.9)
- Operating profit (EBIT) MSEK 8.3 (4.8)
- Net profit after tax MSEK 5.5 (4.1)
- Earnings per share SEK 0.38 (0.33)
- Operating cash flow per share SEK 1.52 (0.50)
*Note that the positive share-price trend during the first six months of 2015 resulted in accounting provisions related to incentive schemes being charged to earnings in the amount of MSEK 4.5 during the first six months of the year and MSEK 2.7 in the second quarter of 2015.
SIGNIFICANT EVENTS DURING THE SECOND QUARTER
- Moberg Pharma acquired product rights for Balmex® in the U.S. for MSEK 33.3 from Chattem, a subsidiary of Sanofi.
- Eurostars awarded a research grant of MSEK 8.4 for further product development and clinical study of BUPI.
- The European Patent Office issued patent number 2,777,689 for Kerasal Nail®
- The company's partner Menarini Asia-Pacific began the launch of Kerasal Nail® in China
SIGNIFICANT EVENTS AFTER THE QUARTER
• No significant events
EBITDA margin, rolling 12 months
TELEPHONE CONFERENCE
CEO Peter Wolpert will present the report at a teleconference today at 3:00 p.m. CET, August 11, 2015. Telephone: SE: +46 8 566 427 00, US: +1 855 831 59 45
CEO COMMENTARY
Strong performance across the board, including launches in Asia as a key driver, resulted in a second quarter with excellent topline growth and improved profitability. This was our 21st consecutive quarter with sequential growth. Year-on-year, net sales grew by 60% (40%, at fixed exchange rates) and EBITDA improved by 62%, representing an EBITDA margin of 12% for the quarter1 and 17% for the first six months2 of the year. The gross margin remains strong at 78% (78%). The Commercial EBITDA margin of 18% for the second quarter3 and 25% for the first six months4 reflect the seasonality in marketing spend for our brands, which is intensified during the second quarter.
Growth in U.S. direct sales
U.S. direct sales grew 76% in the second quarter (48% at fixed exchange rates). Kerasal Nail® was a key growth driver with a U.S. market share slightly increasing to 23%5 , including our two recent line extensions. However, the category for branded fungal nail OTC products declined by 11% in the second quarter, impacted by heavy consumer advertising from prescription onychomycosis drugs and the introduction of additional store brands. All in all, increased attention and rapid growth of new prescription drugs have resulted in substantial growth of the total nail fungus market during the last 12 months.
Balmex®, with products for diaper rash, was acquired at the end of April, and the brand immediately contributed to sales and earnings. The integration of Balmex® is progressing according to plan.
Asian launch strong growth driver in distributor sales
Distributor sales grew by 26% in the second quarter excluding milestone payments (23% at fixed exchange rates). As expected, the strong growth in RoW markets continues, with a significant contribution coming from Asia. Launch in China began in May and previously launched Asian markets have continued to perform well, with excellent sales in Hong Kong and Malaysia.
Sales to European distributors declined slightly in the second quarter but were up 14% for the first six months. We see further potential in some European markets. Sales and market shares in Canada remain strong. Jointflex® sales to distributors were lower in Q2, reflecting large orders delivered in Q1.
Innovation engine – Significant grant for BUPI
Our innovation engine continues to yield results. In addition to the patents granted during the first quarter, a European patent was granted in May for an improved formulation of Emtrix®/Nalox™. We were also pleased to receive a highly ranked Eurostars grant application for BUPI. The MSEK 8.4 grant provides excellent cofinancing for a future Phase III study, provided that phase II results expected in Q4 this year are positive. Partner discussions for MOB-015 are also progressing with a continued focus on retaining rights for key territories through Phase III.
Positioned to drive further growth and value creation
Our base business is profitable and growing. We continue to focus on our long-term goal of becoming the number one player in nail fungus and driving growth organically as well as through targeted acquisitions. A solid cash position, positive cash flow and low debt provide excellent opportunities to use debt as our primary financing source for additional accretive acquisitions.
Peter Wolpert, CEO Moberg Pharma
1 15% excluding accounting provisions related to incentive schemes
2 20% excluding accounting provisions related to incentive schemes
3 21% excluding accounting provisions related to incentive schemes
4 28% excluding accounting provisions related to incentive schemes
5 U.S. retail sales of nail fungus products excluding private label in Multioutlet Stores over the last 52 weeks ending June 14 , 2015 as reported by SymphonyIRI
ABOUT MOBERG PHARMA
Moberg Pharma AB (publ.) is a rapidly growing Swedish pharmaceutical company. The company develops, acquires and licenses products that are subsequently commercialized via a direct sales organization in the U.S. and through distributors in more than 40 countries. Internal product development is based on Moberg Pharma's unique expertise in using innovative pharmaceutical formulations to develop improved products based on proven compounds. This approach reduces time to market, development costs and risk.
Launched products
| PRODUCT | INDICATION | STATUS |
|---|---|---|
| Kerasal Nail® Emtrix® Nalox™ |
Damaged nails | Direct sales in the U.S. Launched by 10 partners in about 30 markets |
| Kerasal® | Dry feet and cracked heels Foot pain |
Direct sales in the U.S. Launched by 13 partners in 15 markets |
| Domeboro® | Itching and irritated skin |
Direct sales in the U.S. |
| Balmex® | Diaper rash | Direct sales in the U.S. |
| Jointflex® | Joint and muscle pain |
Direct sales in the U.S. Launched by 14 partners in 22 markets |
| Vanquish® | Headache, menstrual pain, back and muscle pain |
Direct sales in the U.S. |
| Fergon® | Iron supplement | Direct sales in the U.S. |
Nalox™/Kerasal Nail®
Clinically proven for the treatment of nail fungus. The product was launched in the Nordic region in autumn 2010 and quickly became market leader. The international launch is under way via a direct sales organization in the U.S. and ten partners that have contracted rights for more than 60 markets, including the major EU markets, Canada, China, and South East Asia. Nalox™ is a prescription-free, over the counter product sold under the names Naloc™ and Emtrix® in certain markets and Kerasal Nail® in the U.S.6 . Efficacy and safety have been documented in several clinical trials encompassing more than 600 patients. Nalox™ has a unique and rapid mechanism of action, demonstrating very competitive results, which brings visible improvements within 2-4 weeks of treatment.
Kerasal®
Kerasal® is a product line for the effective treatment of common and difficult-to-treat foot problems. Podiatrists recommend Kerasal® products for the treatment of dry feet, cracked heals and foot pain. A number of clinical studies have been published that document the efficacy of Kerasal®.
Domeboro®
Domeboro® is a topical drug for the treatment of itching and irritated skin, for example, caused by phytotoxins, insect bites or reaction from washing detergent/cosmetics. The product has a drying and astringent effect (contributes to the contraction of blood cells in the skin), which reduces inflammation.
Balmex®
Balmex® has been a well-known brand for many years, offering products for diaper rash, primarily for children. A product line for skin irritation among adults was launched in 2013. The products were acquired from Chattem (Sanofi) in April 2015.
JointFlex®
JointFlex® is a topical treatment for joint and muscle pain. The product provides long-term cooling pain relief and contains natural pain-relieving ingredients.
Vanquish®
Vanquish® is an analgesic for the treatment of headaches, menstrual pains, back and muscle aches and cold pains.
Fergon®
Fergon® is an iron supplement marketed primarily to women.
6 The Nalox™ and Naloc™ brands are owned by the company's partners and Moberg Pharma has no ownership rights in relation to these brands.
Development projects
MOB-015 - Phase III preparations under way
MOB-015 is a new topical treatment for onychomycosis with fungicidal, keratolytic and emollient properties. Moberg Pharma's patent-pending formulation technology enables the transportation of high concentrations of a fungicidal substance (terbinafine) in and through nail tissue. As MOB-015 is applied locally, the side effects associated with oral treatment are avoided. The company estimates the peak sales potential of the product to MUSD 250-500. Data from an earlier Phase II study provided crucial information for the continued development program and, in December 2012, a new Phase II study of an improved formulation of MOB-015 was initiated jointly with leading expertise from Sahlgrenska University Hospital in Gothenburg. Patients with 25-75% of a large toenail affected by nail fungus were treated for 12 months and monitored for an additional three months with respect to the endpoints that the FDA and EMA normally accept for the medical indication. Positive results from this study were reported in September 2014 and presented at the American Academy of Dermatology in March 2015. The primary treatment objective, mycological cure, was achieved in 13 of the 24 patients (54%) who participated in the study. The secondary treatment objective, mycological cure and excellent clinical improvement or cure, was achieved by seven of the 24 patients (29%). Biopsies confirmed high levels of terbinafine in the nail plate and nail bed. MOB015 also displayed a favorable sideeffect profile. This study included patients with more severe onychomycosis than recently published studies of topical treatment alternatives.
BUPI - Bupivacaine lozenge - Phase II studies under way
An innovative and patent-pending lozenge formulation of the proven compound bupivacaine for treatment of oral pain. As the initial medical indication, Moberg Pharma has chosen pain management for patients suffering from oral mucositis during cancer therapy. Promising clinical data supporting safety and efficacy has been shown in several pilot studies – most importantly that the novel lozenge formulation provides significantly longer and better pain relief than currently available non-opioid treatment alternatives for patients with oral mucositis. Moberg Pharma initiated a Phase II study of oral mucositis during the fourth quarter 2014. Moberg Pharma has also identified several additional potential indications for the product, such as Sjögren's Syndrome, Burning Mouth Syndrome, endoscopic procedures, oral intubations and longterm OTC use for sore throat. The company estimates the peak sales potential of the product to be MUSD 50- 100 assuming successful commercialization in oral mucositis and at least one additional medical indication.
BUSINESS DEVELOPMENT DURING THE FIRST SIX MONTHS OF 2015
Kerasal Nail® approved and launched in China
In January 2015, Moberg Pharma's partner, Menarini Asia-Pacific, obtained approval for Kerasal Nail® in China. The product launch in China, including television commercials and other marketing, commenced in May. Launch preparations are under way in a number of markets in the region.
Moberg Pharma and Menarini Group expanded collaboration to include Russia and Ukraine
In February 2015, Berlin-Chemie AG, part of Menarini Group, was granted exclusive rights to market and sell Emtrix® in Russia and Ukraine.
Approved patents in the U.S. and Europe
The USPTO approved U.S. patent number 8,952,070 and the EPO issued European patent number 2,672,962 applying to MOB-015, with expected patent term until 2032. The USPTO also issued a U.S. patent number 8,987,330 and the EPO also issued European patent number 2,777,689 for Kerasal Nail®, with expected patent terms until 2034.
Launch of new Kerasal® product in the U.S.
In February, deliveries to Walgreens started for Kerasal® Complete Care, a new foot care product in a duopack comprising two effective treatments that restore healthy appearance to nails suffering from nail fungus and treat athlete's foot. The product is targeted at the large group of patients who suffer from both nail fungus and athlete's foot.
Acquisition of OTC products in the U.S.
Balmex®, a well-established U.S. brand featuring a number of non-prescription products from Chattem, Inc, the Sanofi division for OTC products in the U.S., was acquired in April 2015. Sales of the constituent products exceed MUSD 4 annually. The consideration amounted to MSEK 33.3 (MUSD 3.9) and was financed by using existing funds. Balmex® has been a well-known brand for many years, offering products for diaper rash, primarily for children. A product line for skin irritation among adults was launched in 2013. Balmex is sold via Moberg's established sales channels in the U.S., via such drugstore chains as CVS, Walgreens and RiteAid and in mass retailers such as Walmart and toy stores such as Toys "R" Us and buybuyBABY.
Eurostars awarded a research grant of MSEK 8.4
Eurostars decided to award a research grant of MSEK 8.4 (MEUR 0.9) for further product development and clinical study of BUPI. The project will be led by Moberg Pharma and carried out in collaboration with six external partners in Sweden and Denmark: Oracain ApS, TFS Trial Form Support ApS, Aarhus University Hospital, Herlev Hospital, PCG Clinical Services AB and Skåne University Hospital. The grant from Eurostars will be used to co-finance the continued development of the products including a clinical Phase III study.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD
Higher number of shares
The number of shares and votes rose 39,000 to 14,001,537 in July 2015. The change was due to warrants in Moberg Pharma being exercised under the framework of the company's share-based incentive schemes.
CONSOLIDATED REVENUE AND EARNINGS
Sales
Second quarter (April-June 2015)
In the second quarter of 2015, revenue amounted to MSEK 92.2 (57.7), up 60% year-on-year. Of total product sales, revenue for Nalox™/Kerasal Nail® accounted for MSEK 60.6 (35.9), while Kerasal® and JointFlex® accounted for MSEK 9.3 (7.6) and MSEK 6.4 (7.1), respectively. Other products contributed MSEK 15.6 (7.1). The Balmex® product was acquired from Chattem, Inc, the Sanofi division for OTC products in the U.S., on April 27, 2015 and sales of Balmex are included in the income statement from this date. Other operating income primarily comprises exchange-rate fluctuations associated with operating receivables.
The company is dependent on the trend in the USD and EUR in relation to the SEK, since the USD and EUR account for the predominant portion of sales. During the second quarter of 2015, USD revenue was booked at an average exchange rate of SEK 8.37, compared with SEK 6.53 in the second quarter of 2014. During the second quarter of 2015, EUR revenue was booked at an average exchange rate of SEK 9.34, compared with SEK 8.95 in the second quarter of 2014. Accordingly, exchange rates had a positive impact on revenue. At fixed exchange rates, revenue would have risen 40% year-on-year.
Six-month period (January-June 2015)
During the January-June 2015 period, revenue amounted to MSEK 165.3 (105.5), up 57%. The majority, MSEK 101.6 (61.7), derived from product sales of Nalox™/ Kerasal Nail®. Product sales revenue amounted to MSEK 18.4 (16.7) for Kerasal®, MSEK 18.8 (12.9) for JointFlex® and MSEK 24.2 (12.3) for other products. Sales amounted to MSEK 25.9 (22.6) in Europe, MSEK 117.2 (78.4) in the U.S. and MSEK 22.2 (4.4) in the rest of the world.
| Distribution of revenue | Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year |
|---|---|---|---|---|---|
| (KSEK) | 2015 | 2014 | 2015 | 2014 | 2014 |
| Sales of products | 91,918 | 57,706 | 162,982 | 103,691 | 198,011 |
| Milestone payments | 232 | - | 2,346 | 1,762 | 2,169 |
| Revenue | 92,150 | 57,706 | 165,328 | 105,453 | 200,180 |
| Other operating income | 227 | 161 | 5,204 | 538 | 5,791 |
| Total revenue | 92,377 | 57,867 | 170,532 | 105,991 | 205,971 |
7
Revenue from product sales per quarter
| Revenue by channel | Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year |
|---|---|---|---|---|---|
| (KSEK) | 2015 | 2014 | 2015 | 2014 | 2014 |
| Direct sales | 67,060 | 38,054 | 113,809 | 71,974 | 138,918 |
| Sales of products to distributors | 24,858 | 19,652 | 49,173 | 31,717 | 59,093 |
| Milestone payments | 232 | - | 2,346 | 1,762 | 2,169 |
| TOTAL | 92,150 | 57,706 | 165,328 | 105,453 | 200,180 |
| Revenue by product category | Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year |
|---|---|---|---|---|---|
| (KSEK) | 2015 | 2014 | 2015 | 2014 | 2014 |
| Nalox/Kerasal Nail®, sales of products | 60,571 | 35,875 | 101,597 | 61,702 | 112,709 |
| Nalox/Kerasal Nail®, milestone payments | 232 | - | 2,346 | 1,762 | 2,169 |
| Kerasal® | 9,292 | 7,596 | 18,410 | 16,723 | 29,035 |
| JointFlex® | 6,420 | 7,105 | 18,768 | 12,933 | 30,908 |
| Other products | 15,635 | 7,131 | 24,207 | 12,333 | 25,359 |
| TOTAL | 92,150 | 57,706 | 165,328 | 105,453 | 200,180 |
Distribution of revenue as a percentage, January - June 2015
| Revenue by geographical market (KSEK) |
Apr-Jun 2015 |
Apr-Jun 2014 |
Jan-Jun 2015 |
Jan-Jun 2014 |
Full-year 2014 |
|---|---|---|---|---|---|
| Europe | 12,262 | 13,822 | 25,887 | 22,621 | 30,115 |
| North and South America | 67,843 | 42,829 | 117,213 | 78,428 | 148,112 |
| Rest of the world | 12,045 | 1,055 | 22,228 | 4,404 | 21,953 |
| TOTAL | 92,150 | 57,706 | 165,328 | 105,453 | 200,180 |
Earnings
Second quarter (April-June 2014)
Operating profit for the second quarter of 2015 was MSEK 8.3 (4.8). The cost of goods sold was MSEK 20.6 (12.9), corresponding to a gross margin on product sales of 78% (78%). Operating expenses, excluding cost of goods sold during the quarter, amounted to MSEK 63.5 (40.1), most of which comprised selling expenses of MSEK 47.9 (27.7).
The Group's employee stock option costs (including estimated costs for social security contributions) increased in 2015 due to the higher share price and the revaluation of estimated costs for social security contributions for employee stock options of MSEK 4.5 being charged to operating profit for January-June 2015, of which MSEK 2.7 for the second quarter.
EBITDA for the quarter amounted to 12% (12%). EBITDA was 15% excluding accounting provisions related to incentive schemes. Adjusted for R&D expenses for future products, EBITDA for the existing product portfolio was 18% (19%).
Six-month period (January-June 2014)
Operating profit for the first six months of 2015 was MSEK 23.2 (10.5). The cost of goods sold was MSEK 37.1 (22.7). Operating expenses, excluding the cost of goods sold, amounted to MSEK 110.3, compared with MSEK 72.7 in the year-earlier period.
Profit after financial items amounted to MSEK 22.8, compared with MSEK 9.6 for the January to June 2014 period. The earnings improvement was primarily due to higher sales with retained/improved margins, whereby sales revenue increased 57% during the period and the cost of goods sold rose 63%, while operating expenses increased 52% during the first six months of 2015.
Profit for the period after tax was MSEK 16.4 (8.1) and comprehensive income was MSEK 26.6 (13.2). The improvement in comprehensive income includes currency translation gains of MSEK 10.3 due to the stronger USD.
EBITDA for the first six months of 2014 amounted to 17% (14%). EBITDA was 20% excluding accounting provisions related to incentive schemes. Adjusted for R&D expenses for future products, EBITDA for the existing product portfolio was 25% (21%). The variance in EBITDA margin for the second quarter and for the first six months reflect the seasonality in marketing spend for our brands, which is intensified during the second quarter.
| EBITDA summary | Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year |
|---|---|---|---|---|---|
| (KSEK) | 2015 | 2014 | 2015 | 2014 | 2014 |
| Revenue | 92,150 | 57,706 | 165,328 | 105,453 | 200,180 |
| Cost of goods sold | -20,644 | -12,918 | -37,069 | -22,742 | -49,064 |
| Gross profit | 71,506 | 44,788 | 128,259 | 82,711 | 151,116 |
| % | 78% | 78% | 78% | 78% | 75% |
| Selling expenses | -45,338 | -26,107 | -74,788 | -45,880 | -85,648 |
| Administrative expenses | -5,323 | -6,149 | -10,341 | -10,889 | -20,622 |
| Research and development expenses - commercial operations1) |
-2,536 | -1,754 | -3,787 | -3,904 | -7,251 |
| Other operating income/operating expenses | -1,997 | 161 | 2,526 | 538 | 5,791 |
| EBITDA Commercial Operations | 16,312 | 10,939 | 41,869 | 22,577 | 43,387 |
| % | 18% | 19% | 25% | 21% | 22% |
| Research and development expenses - future products2) |
-3,493 | -2,794 | -9,971 | -5,217 | -12,283 |
| Business development expenses | -1,671 | -1,246 | -3,379 | -2,926 | -5,809 |
| EBITDA | 11,148 | 6,899 | 28,519 | 14,434 | 25,295 |
| % | 12% | 12% | 17% | 14% | 13% |
| Depreciation/amortization | -2,866 | -2,066 | -5,338 | -3,904 | -8,068 |
| Operating profit (EBIT) | 8,282 | 4,833 | 23,181 | 10,530 | 17,227 |
1) Research and development expenses – commercial operations includes R&D expenses for new product variants under existing brands, regulatory work and quality.
2) Research and development expenses - future products includes R&D expenses for new product candidates, for example, BUPI.
FINANCIAL POSITION
Cash flow
Second quarter (April-June 2015)
Cash flow from operating activities amounted to MSEK 21.9 (6.2) for the second quarter.
Six-month period (January-June 2015)
Operating cash flow before changes in working capital improved substantially during the period to MSEK 28.8 (14.2). The company has a season-related increase in tied-up capital through marketing investments and higher orders for the peak season. Cash flow from operating activities amounted to MSEK 16.9 (3.4) for the January to June 2015 period. Cash and cash equivalents were MSEK 34.6 (75.6) at the end of the period.
Capital expenditures
Capital expenditures in intangible fixed assets primarily pertain to the acquisition of product rights for MSEK 33.3 for Balmex® in April 2015.
In addition to the Balmex® acquisition, the company's investments in intangible fixed assets in the first six months of 2015 in the form of computer systems totaled MSEK 1.5 (0) and capitalized expenditure for
research and development work totaled MSEK 3.2 (2.3). In Q2, phase III preparations for MOB-015 were initiated and thus direct development expenses are capitalized starting from this quarter. Moberg Pharma also had R&D costs of MSEK 13.8 (9.5) that were expensed directly in the statement of comprehensive income, of which MSEK 10.0 (5.2) was related to future products.
Liabilities
Interest-bearing liabilities comprise a loan to Swedbank of MSEK 10.0, of which MSEK 6.6 (6.6) was amortized during the period.
Pledged assets and contingent liabilities
Moberg Pharma has no contingent liabilities. All pledged assets remain unchanged from those reported in the 2015 Annual Report.
CHANGES IN EQUITY
Disclosure of ownership
Company's largest shareholders at June 30, 2015:
| Shareholders | No. of shares | % of votes and capital |
|---|---|---|
| THE BALTIC SEA FOUNDATION | 2,274,179 | 16.3 |
| HANDELSBANKEN FONDER AB RE JPMEL | 1,236,414 | 8.9 |
| INSURANCE COMPANY, AVANZA PENSION | 1,078,893 | 7.7 |
| J P MORGAN CLEARING CORP, W9 | 725,533 | 5.2 |
| WOLCO INVEST AB7 | 600,000 | 4.3 |
| GRANDEUR PEAK INTERNATIONAL | 371,800 | 2.7 |
| SOCIETE GENERALE | 298,897 | 2.1 |
| NORDNET PENSIONSFÖRSÄKRING AB | 296,046 | 2.1 |
| BANQUE CARNEGIE LUXEMBOURG S.A, (FUNDS) | 281,494 | 2.0 |
| DEUTSCHE BANK AG, LONDON BRANCH, W-8BEN | 248,256 | 1.8 |
| GRANDEUR PEAK GLOBAL, OPPORTUNITIES | 245,880 | 1.8 |
| STATE STREET BANK & TRUST COM., BOSTON | 180,000 | 1.3 |
| ML, PIERCE, FENNER & SMITH INC | 172,414 | 1.2 |
| SYNSKADADES STIFTELSE | 172,201 | 1.2 |
| SECOND SWEDISH NATIONAL PENSION FUND | 150,000 | 1.1 |
| STATE STREET BANK & TRUST COM., BOSTON | 150,000 | 1.1 |
| LUNDMARK, ANDERS | 142,000 | 1.0 |
| MORGAN STANLEY & CO INTL PLC, W-8BEN | 121,874 | 0.9 |
| TOLVPLUS4 AB | 113,304 | 0.8 |
| GRANDEUR PEAK GLOBAL REACH, FUND | 111,100 | 0.8 |
| TOTAL, 20 LARGEST SHAREHOLDERS | 8,970,285 | 64.3 |
| Other shareholders | 4,992,252 | 35.8 |
| TOTAL | 13,962,537 | 100 |
11
7 Owned by Moberg Pharma's CEO, Peter Wolpert
Shares
At the end of the period, share capital amounted to SEK 1,396,253.70 (1,189,357.20), and the total number of shares outstanding was 13,962,537 (11,893,572) ordinary shares with a nominal value of SEK 0.10. The number of shares and votes rose 39,000 to 14,001,537 in July 2015. The change was due to warrants in Moberg Pharma being utilized under the framework of the company's share-based incentive schemes.
Stock options
On May 11, 2015, the Annual General Meeting of Moberg Pharma AB resolved to implement a private placement of 326,739 warrants (equivalent to 326,739 shares) to the company's wholly owned subsidiary Moberg Derma Incentives AB and to introduce the employee stock option scheme 2015:1. In the employee stock option scheme 2015:1, 288,500 stock options were allotted and 38,239 warrants reserved to cover future social security expenses for the employee stock options. The terms and conditions of the employee stock option scheme 2015:1 comply with the terms and conditions of the employee stock option scheme 2014:1, with the following exceptions: employee stock options in the 2015:1 scheme vest on June 30, 2018 at the earliest, the exercise price is SEK 65.47 per option and the last day for subscription is December 31, 2019. For a description of the terms and conditions of the employee stock option scheme 2014:1, refer to the 2014 Annual Report on page 48. At June 30, 2015, there were a total of 891,130 warrants outstanding. If all warrants were exercised for shares, the number of shares would increase by 1,463,724, from 13,962,537 shares at the end of the period to 15,426,261 shares.
ORGANIZATION
At June 30, 2015, the Moberg Pharma Group had 31 employees, of whom 61% were women. Of these, 21 were employed in the Parent Company, of whom 62% were women.
PARENT COMPANY
Moberg Pharma AB (Publ), Corp. Reg. No. 556697-7426, is the Parent Company of the Group. Group operations are conducted primarily in the Parent Company (in addition to the sales organization in the U.S.) and comprise research and development, sales, marketing and administrative functions. Parent Company revenue amounted to MSEK 76.9 for the period January to June 2015, compared with MSEK 55.8 in 2014. Operating expenses, excluding the cost of goods sold, amounted to MSEK 36.2 (24.0) and profit after financial items to MSEK 26.6 (17.7). Cash and cash equivalents were MSEK 13.8 (71.2) at the end of the period.
RISK FACTORS
Commercialization and development of drugs are capital-intensive activities exposed to significant risks. Risk factors considered to be of particular relevance for Moberg Pharma's future development are linked to competitors and pricing, production, partners' and distributors' performance, the results of clinical trials, regulatory actions, product liability and insurance, patents and trademarks, key personnel, sensitivity to economic fluctuations, future capital requirements and financial risk factors. A description of these risks can be found in the company's 2014 Annual Report on page 23. Over the next 12 months, the most significant risk factors for the company are deemed to be associated with market development, the development of established partnerships, integration of acquisitions and the results of clinical trials.
OUTLOOK
Moberg Pharma aims to create shareholder value and generate a solid return through a focus on profitable growth, targeting a long-term EBITDA margin of at least 25% from 2016 and onwards. The company's growth strategy includes organic sales growth, acquisitions/in-licensing of new products and commercialization of development projects.
In 2015, the focus will be on sales growth and improved earnings. Significant components are identifying further business opportunities, discussions with partners concerning development programs and supporting the company's distributors and retailers.
| (KSEK) | Apr-Jun 2015 |
Apr-Jun 2014 |
Jan-Jun 2015 |
Jan-Jun 2014 |
Full-year 2014 |
|---|---|---|---|---|---|
| Revenue | 92,150 | 57,706 | 165,328 | 105,453 | 200,180 |
| Cost of goods sold | -20,644 | -12,918 | -37,069 | -22,742 | -49,064 |
| Gross profit | 71,506 | 44,788 | 128,259 | 82,711 | 151,116 |
| Selling expenses1) | -47,887 | -27,717 | -79,578 | -48,945 | -93,198 |
| Business development and administrative expenses | -7,085 | -7,516 | -13,863 | -14,319 | -26,552 |
| Research and development expenses | -6,255 | -4,883 | -14,163 | -9,455 | -19,930 |
| Other operating income | 227 | 161 | 5,204 | 538 | 5,791 |
| Other operating expenses | -2,224 | - | -2,678 | - | - |
| Operating profit (EBIT) | 8,282 | 4,833 | 23,181 | 10,530 | 17,227 |
| Interest income and similar items | 3 | 909 | 20 | 1,042 | 905 |
| Interest expense and similar items | -179 | -1,440 | -410 | -2,022 | -1,555 |
| Profit after financial items (EBT) | 8,106 | 4,302 | 22,791 | 9,550 | 16,577 |
| Tax on profit for the period | -2,649 | -233 | -6,423 | -1,411 | -4,309 |
| PROFIT FOR THE PERIOD | 5,457 | 4,069 | 16,368 | 8,139 | 12,268 |
| Items that will be reclassified | |||||
| Translation differences of foreign operations | -9,679 | 4,161 | 10,269 | 5,052 | 33,046 |
| Other comprehensive income | -9,679 | 4,161 | 10,269 | 5,052 | 33,046 |
| COMPREHENSIVE INCOME FOR THE PERIOD | -4,222 | 8,230 | 26,637 | 13,191 | 45,314 |
| Profit for the period attributable to PC shareholders | 5,457 | 4,069 | 16,368 | 8,139 | 12,268 |
| Profit for the period attributable to non-controlling interests |
- | - | - | - | - |
| Comprehensive income/loss att. to PC shareholders | -4,222 | 8,230 | 26,637 | 13,191 | 45,314 |
| Total comprehensive income attributable to non | |||||
| controlling interests | - | - | - | - | - |
| Earnings per share before dilution | 0.39 | 0.33 | 1.17 | 0.67 | 0.96 |
| Earnings per share after dilution | 0.38 | 0.33 | 1.13 | 0.67 | 0.95 |
| 1) Of which amortization of product rights | -2,382 | -1,486 | -4,599 | -2,941 | -7,198 |
| EBITDA | 11,148 | 6,899 | 28,519 | 14,434 | 25,295 |
| Depreciation/amortization of product rights | -2,382 | -1,486 | -4,599 | -2,941 | -7,198 |
| Other depreciation/amortization | -484 | -580 | -739 | -963 | -870 |
| Operating profit (EBIT) | 8,282 | 4,833 | 23,181 | 10,530 | 17,227 |
| EBITDA excluding acquisition-related costs | 11,148 | 6,899 | 28,519 | 14,434 | 25,295 |
13
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| June 30, | June 30, | Dec 31, | |
|---|---|---|---|
| (KSEK) | 2015 | 2014 | 2014 |
| Assets | |||
| Intangible assets | 258,828 | 192,070 | 216,362 |
| Property, plant and equipment | 803 | 1,011 | 934 |
| Financial assets | 1 | 65 | 76 |
| Deferred tax assets | 18,766 | 29,059 | 24,903 |
| Total non-current assets | 278,398 | 222,205 | 242,275 |
| Inventories | 15,292 | 9,178 | 13,135 |
| Trade receivables and other receivables | 88,570 | 51,655 | 41,847 |
| Cash and bank balances | 34,613 | 75,596 | 62,463 |
| Total current assets | 138,475 | 136,429 | 117,445 |
| TOTAL ASSETS | 416,873 | 358,634 | 359,720 |
| Equity and liabilities | |||
| Equity (attributable to Parent Company shareholders) | 331,002 | 271,781 | 303,749 |
| Non-current interest-bearing liabilities | - | 10,000 | 3,333 |
| Non-current non-interest-bearing liabilities | - | 1,920 | - |
| Current interest-bearing liabilities | 10,000 | 13,333 | 13,333 |
| Current non-interest-bearing liabilities | 75,871 | 61,600 | 39,305 |
| TOTAL EQUITY AND LIABILITIES | 416,873 | 358,634 | 359,720 |
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
| (KSEK) | Apr-Jun 2015 |
Apr-Jun 2014 |
Jan-Jun 2015 |
Jan-Jun 2014 |
Full-year 2014 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating profit before financial items | 8,284 | 4,834 | 23,187 | 10,531 | 17,231 |
| Financial items, received and paid | -157 | -69 | -367 | -534 | -1,350 |
| Taxes paid | - | - | -17 | 3 | 3 |
| Adjustments for non-cash items: | |||||
| Depreciation/amortization | 2,866 | 2,066 | 5,338 | 3,904 | 8,068 |
| Employee stock option costs8 | 498 | 138 | 616 | 278 | 112 |
| Cash flow before changes in working capital | 11,491 | 6,969 | 28,757 | 14,182 | 24,064 |
| Change in working capital | |||||
| Increase (-) / Decrease (+) in inventories | 1,248 | -1,356 | -938 | -2,210 | -2,529 |
| Increase (-) / Decrease (+) in operating receivables |
-15,588 | -19,691 | -46,070 | -24,314 | -13,259 |
| Increase (+) / Decrease (-) in operating liabilities9 |
24,714 | 20,291 | 35,065 | 15,701 | 7,886 |
| CASH FLOW FROM OPERATING ACTIVITIES |
21,865 | 6,213 | 16,814 | 3,359 | 16,162 |
| Investing activities | |||||
| Net investments in intangible fixed assets | -35,863 | -2,528 | -38,045 | -4,310 | -7,230 |
| Net investments in equipment | - | - | -58 | - | -42 |
| Net investments in subsidiaries | - | - | - | - | -17,225 |
| CASH FLOW FROM INVESTING ACTIVITIES | -35,863 | -2,528 | -38,103 | -4,310 | -24,497 |
| Financing activities | |||||
| Borrowings (+) / Repayment of loans (-) | -3,334 | -3,334 | -6,667 | -6,667 | -13,333 |
| New share issue after transaction costs | - | 55,937 | - | 55,937 | 55,937 |
| CASH FLOW FROM FINANCING ACTIVITIES | -3,334 | 52,603 | -6,667 | 49,270 | 42,604 |
| Change in cash and cash equivalents | -17,332 | 56,288 | -27,956 | 48,319 | 34,269 |
| Cash and cash equivalents at the start of the period |
52,655 | 19,227 | 62,463 | 27,138 | 27,138 |
| Exchange-rate difference in cash and cash equivalents |
-710 | 81 | 106 | 139 | 1,056 |
| Cash and cash equivalents at the end of the period |
34,613 | 75,596 | 34,613 | 75,596 | 62,463 |
8 Note that revaluation of estimated costs for social security contributions for employee stock options is reported in change in operating liabilities
9 Revaluation of estimated costs for social security contributions for employee stock options increases operating liabilities with MSEK 2.7 (0.1) for Q2 and MSEK 4.5 (decrease with 0.1) for the half year period
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
| Share capital |
Other capital contributions |
Translation reserve |
Accumulated deficit |
Total equity |
|
|---|---|---|---|---|---|
| (KSEK) | |||||
| January 1, 2015 - June 30, 2015 | |||||
| Opening balance, January 1, 2015 | 1,396 | 357,305 | 29,490 | -84,442 | 303,749 |
| Comprehensive income | |||||
| Results for the period | 16,368 | 16,368 | |||
| Other comprehensive income - translation differences on translation of foreign operations |
10,269 | 10,269 | |||
| Transactions with shareholders | |||||
| Employee stock options | 616 | 616 | |||
| CLOSING BALANCE, JUNE 30, 2015 | 1,396 | 357,921 | 39,759 | -68,074 | 331,002 |
| January 1, 2014 - June 30, 2014 | |||||
| Opening balance, January 1, 2014 | 1,189 | 300,569 | -3,554 | -96,710 | 201,494 |
| Comprehensive income | |||||
| Results for the period | 8,139 | 8,139 | |||
| Other comprehensive income - translation | |||||
| differences on translation of foreign operations |
5,052 | 5,052 | |||
| Transactions with shareholders | |||||
| New share issue | 207 | 59,793 | 60,000 | ||
| Transaction costs, new share issue | -3,169 | -3,169 | |||
| Employee stock options | 265 | 265 | |||
| CLOSING BALANCE, JUNE 30, 2014 | 1,396 | 357,458 | 1,498 | -88,571 | 271,781 |
| January 1, 2013 – December 31, 2014 | |||||
| Opening balance, January 1, 2014 | 1,189 | 300,569 | -3,554 | -96,710 | 201,494 |
| Comprehensive income | |||||
| Results for the period | 12,268 | 12,268 | |||
| Other comprehensive income – translation | |||||
| differences attributable to translation of |
33,044 | 33,044 | |||
| foreign operations Transactions with shareholders |
|||||
| New share issue | 207 | 59,793 | 60,000 | ||
| Transaction costs, new share issue | -3,169 | -3,169 | |||
| Employee stock options | 112 | 112 | |||
| CLOSING BALANCE, DECEMBER 31, 2014 | 1,396 | 357,305 | 29,490 | -84,442 | 303,749 |
KEY FIGURES FOR THE GROUP
| (KSEK) | Apr-Jun 2015 |
Apr-Jun 2014 |
Jan-Jun 2015 |
Jan-Jun 2014 |
Full-year 2014 |
|---|---|---|---|---|---|
| Revenue | 92,150 | 57,706 | 165,328 | 105,453 | 200,180 |
| Gross margin, % | 78% | 78% | 78% | 78% | 75% |
| Gross margin on product sales, % excluding acquisition-related costs and items affecting comparability |
78% | 78% | 77% | 78% | 75% |
| EBITDA excluding acquisition-related costs | 11,148 | 6,899 | 28,519 | 14,434 | 25,295 |
| EBITDA % excluding acquisition-related costs | 12% | 12% | 17% | 14% | 13% |
| EBITDA | 11,148 | 6,899 | 28,519 | 14,434 | 25,295 |
| Operating profit (EBIT) | 8,282 | 4,833 | 23,181 | 10,530 | 17,227 |
| Profit after tax | 5,457 | 4,069 | 16,368 | 8,139 | 12,268 |
| Profit margin, % | 6% | 7% | 10% | 8% | 6% |
| Total assets | 416,873 | 358,634 | 416,873 | 358,634 | 359,720 |
| Net receivables | 24,613 | 52,263 | 24,613 | 52,263 | 45,797 |
| Debt/equity ratio | 3% | 9% | 3% | 9% | 5% |
| Equity/assets ratio | 79% | 76% | 79% | 76% | 84% |
| Return on equity | 2% | 1% | 5% | 3% | 4% |
| Earnings per share, SEK | 0.38 | 0.33 | 1.13 | 0.67 | 0.95 |
| Operating cash flow per share, SEK | 1.52 | 0.50 | 1.20 | 0.28 | 1.27 |
| Equity per share, SEK | 23.71 | 19.47 | 23.71 | 19.47 | 21.75 |
| Average number of shares before dilution | 13,962,537 | 12,280,082 | 13,962,537 | 12,087,895 | 12,719,642 |
| Average number of shares after dilution | 14,416,208 | 12,420,506 | 14,465,025 | 12,228,582 | 12,859,499 |
| Number of shares at end of period | 13,962,537 | 13,962,537 | 13,962,537 | 13,962,537 | 13,962,537 |
| Share price on the closing date, SEK | 62.75 | 29.40 | 62.75 | 29.40 | 38.00 |
| Market capitalization on the closing date, MSEK |
876 | 410 | 876 | 410 | 531 |
Definitions of key figures
| Net receivables | Cash and cash equivalents less interest-bearing liabilities |
|---|---|
| Debt/equity ratio | Interest-bearing liabilities in relation to equity |
| Equity/assets ratio | Equity at year-end in relation to total assets |
| Return on equity | Profit/loss for the period divided by equity |
| Earnings per share* | Profit after tax divided by the average number of shares outstanding after dilution |
| Operating cash flow per share* | Cash flow from operating activities divided by the average number of shares outstanding after dilution |
| Equity per share | Equity divided by the number of shares outstanding at the end of the period |
* In periods during which the Group reported a loss, no dilution effect has occurred. This is because dilution is recognized only when a potential conversion to ordinary shares would mean that earnings per share would be lower.
| (KSEK) | Apr-Jun 2015 |
Apr-Jun 2014 |
Jan-Jun 2015 |
Jan-Jun 2014 |
Full-year 2014 |
|---|---|---|---|---|---|
| Revenue | 34,258 | 33,269 | 76,942 | 55,750 | 93,775 |
| Cost of goods sold | -9,779 | -8,367 | -19,429 | -14,310 | -29,322 |
| Gross profit | 24,479 | 24,902 | 57,513 | 41,440 | 64,453 |
| Selling expenses | -4,620 | -2,677 | -8,177 | -5,076 | -13,293 |
| Business development and administrative expenses |
-6,101 | -5,075 | -11,710 | -9,479 | -16,746 |
| Research and development expenses | -5,867 | -4,883 | -13,602 | -9,455 | -19,930 |
| Other operating income | 314 | 161 | 5,166 | 538 | 5,791 |
| Other operating expenses | -2,219 | - | -2,673 | - | - |
| Operating profit | 5,986 | 12,428 | 26,517 | 17,968 | 20,275 |
| Interest income | 143 | 796 | 516 | 1,209 | 2,122 |
| Interest expense | -180 | -942 | -402 | -1,520 | -1,546 |
| Profit after financial items | 5,949 | 12,282 | 26,631 | 17,657 | 20,851 |
| Tax on profit for the period | -1,945 | -2,655 | -6,920 | -3,908 | -4,822 |
| PROFIT | 4,004 | 9,627 | 19,711 | 13,749 | 16,029 |
CONDENSED PARENT COMPANY BALANCE SHEET
| (KSEK) | June 30, 2015 | June 30, 2014 | Dec 31, 2014 |
|---|---|---|---|
| Assets | |||
| Intangible assets | 79,578 | 40,854 | 42,966 |
| Property, plant and equipment | 404 | 541 | 470 |
| Financial assets | 178,107 | 178,107 | 178,107 |
| Deferred tax assets | 10,939 | 18,772 | 17,859 |
| Total non-current assets | 269,028 | 238,274 | 239,402 |
| Inventories | 2,097 | - | 155 |
| Trade receivables and other receivables | 30,938 | 25,891 | 20,047 |
| Receivables to Group companies | 42,794 | 25,790 | 23,914 |
| Cash and bank balances | 13,777 | 71,208 | 56,062 |
| Total current assets | 89,606 | 122,889 | 100,178 |
| TOTAL ASSETS | 358,634 | 361,163 | 339,580 |
| Equity and liabilities | |||
| Shareholders' equity | 318,848 | 295,796 | 298,283 |
| Non-current interest-bearing liabilities | - | 10,000 | 3,333 |
| Current interest-bearing liabilities | 10,000 | 13,333 | 13,333 |
| Current non-interest-bearing liabilities | 29,786 | 42,034 | 24,631 |
| TOTAL EQUITY AND LIABILITIES | 358,634 | 361,163 | 339,580 |
CONDENSED PARENT COMPANY CASH-FLOW STATEMENT
| (KSEK) | Apr-Jun 2015 |
Apr-Jun 2014 |
Jan-Jun 2015 |
Jan-Jun 2014 |
Full-year 2014 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating profit before financial items | 5,986 | 12,428 | 26,517 | 17,968 | 20,275 |
| Financial items, received and paid | -158 | -69 | -369 | -534 | -123 |
| Taxes paid | - | - | - | - | - |
| Adjustments for non-cash items: | |||||
| Depreciation/amortization | 966 | 578 | 1,557 | 957 | 1,878 |
| Employee stock option costs | 188 | 19 | 285 | 60 | 267 |
| Cash flow before changes in working capital |
6,982 | 12,956 | 27,990 | 18,451 | 22,297 |
| Change in working capital | |||||
| Increase (-) / Decrease (+) in inventories | -1,892 | - | -1,942 | - | -155 |
| Increase (-) / Decrease (+) in operating receivables |
1,903 | -6,028 | -28,673 | -19,955 | -12,394 |
| Increase (+) / Decrease (-) in operating liabilities |
5,216 | 4,638 | 5,110 | 5,508 | 5,963 |
| CASH FLOW FROM OPERATING ACTIVITIES |
12,209 | 11,566 | 2,485 | 4,004 | 15,711 |
| Investing activities | |||||
| Net investments in intangible assets | -35,863 | -2,528 | -38,045 | -4,310 | -7,230 |
| Net investments in equipment | - | - | -58 | - | -42 |
| Net investments in subsidiaries | - | - | - | - | -17,225 |
| CASH FLOW FROM INVESTING ACTIVITIES | -35,863 | -2,528 | -38,103 | -4,310 | -24,497 |
| Financing activities | |||||
| Borrowings (+) / Repayment of loans (-) | -3,334 | -3,334 | -6,667 | -6,667 | -13,333 |
| New share issue after transaction costs | - | 55,937 | - | 55,937 | 55,937 |
| CASH FLOW FROM FINANCING ACTIVITIES |
-3,334 | 52,603 | -6,667 | 49,270 | 42,604 |
| Change in cash and cash equivalents | -26,988 | 61,641 | -42,285 | 48,964 | 33,818 |
| Cash and cash equivalents at the start of | 40,765 | 9,567 | 56,062 | 22,244 | 22,244 |
| the period | |||||
| Cash and cash equivalents at the end of the period |
13,777 | 71,208 | 13,777 | 71,208 | 56,062 |
ACCOUNTING AND VALUATION POLICIES
This interim report has been prepared in accordance with IAS 34 and the Swedish Annual Accounts Act. The consolidated financial statements have, in common with the annual accounts for 2014, been prepared in accordance with the International Financial Reporting Standards (IFRS) as adopted by the EU, and the Swedish Annual Accounts Act. The Parent Company accounts have been prepared in accordance with the Annual Accounts Act and the Swedish Financial Reporting Board's recommendation RFR 2 Accounting for Legal Entities.
The Group applies the same accounting policies and calculation methods as described in the 2014 Annual Report. A number of new or revised standards, interpretations and improvements have been adopted by the EU and are to be applied from January 1, 2015. These changes have not had any significant effect on the Group.
Amounts are expressed in SEK rounded to the nearest thousand unless otherwise stated. Due to the rounding component, totals may not tally. MSEK is an abbreviation of million Swedish kronor. KSEK is an abbreviation of thousand Swedish kronor. Amounts and figures in parentheses are comparative figures from the preceding year.
SEGMENT REPORTING
Since Moberg Pharma's operations comprise only one area of operation, the commercialization and development of medical products, the consolidated statement of comprehensive income and statement of financial position as a whole comprise one operating segment.
RELATED-PARTY TRANSACTIONS
No significant changes have occurred in relations and transactions with related parties.
FINANCIAL INSTRUMENTS
As on December 31, 2014, the fair value of financial instruments approximates to their carrying amount.
FUTURE REPORTING DATES
Interim report for January – September 2015 November 10, 2015
FOR MORE INFORMATION, PLEASE CONTACT
Peter Wolpert, CEO, tel. +46 (0)8-522 307 00, [email protected] Anna Ljung, CFO, tel. +46 (0)8-522 307 01, [email protected]
For more information about Moberg Pharma's operations, please visit the company's website at www.mobergpharma.com
This interim report is unaudited.
BOARD DECLARATION
The undersigned certify that the Interim Report provides a fair overview of the operations, financial position and results of the Parent Company and Group, as well as a fair description of significant risks and uncertainties faced by the Parent Company and Group companies.
Bromma, August 10, 2015
Mats Pettersson Chairman
Wenche Rolfsen Board member
Torbjörn Koivisto Board member
Thomas Thomsen Board member
Geert Cauwenbergh Board member
Thomas Eklund Board member
Mattias Klintemar Board member
Peter Wolpert CEO