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Moberg Pharma — Interim / Quarterly Report 2013
Aug 6, 2013
3174_ir_2013-08-06_1938eeeb-9b7c-49ad-9d4a-ae5bb7b49c97.pdf
Interim / Quarterly Report
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CONTINUED GROWTH AND INCREASED FINANCIAL STRENGTH PREPARING FOR PORTFOLIO EXPANSION
"Strong demand for our products, a larger geographical reach on the basis of new and expanded distribution agreements and a strengthened financial position provide excellent conditions for continuing to build a different kind of pharmaceutical company. We are now ready to facilitate further growth by adding several products and projects to our portfolio through acquisitions and in-licensing," comments Peter Wolpert, CEO, Moberg Pharma
FIRST SIX MONTH (JAN-JUN 2013)
- Revenue MSEK 83.4 (55.5)
- EBITDA MSEK -7.3 (9.4), loss of MSEK 4.2 excluding acquisition-related costs
- Operating loss (EBIT) MSEK 10.3 (profit: 9.3)
- Net loss after tax MSEK 7.0 (profit: 39.4)
- Loss per share SEK 0.65 (earnings: 4.33)
- Operating cash flow per share negative SEK 0.09 (pos: 0.64)
SECOND QUARTER (APR-JUN 2013)
- Revenue MSEK 44.9 (24.5)
- EBITDA MSEK -5.1 (1.4), loss of MSEK 5.1 excluding acquisition-related costs
- Operating loss (EBIT) MSEK 6.6 (profit: 1.4)
- Net loss after tax MSEK 4.3 (profit: 1.4)
- Loss per share SEK 0.39 (earnings: 0.15)
- Operating cash flow per share negative SEK 0.06 (pos: 1.71)
SIGNIFICANT EVENTS DURING THE SECOND QUARTER
- The company changed its corporate identity to Moberg Pharma
- Moberg Pharma and Paladin expanded their distribution agreement for Kerasal Nail™ to Mexico
- Patient enrollment completed in clinical study of MOB-015
SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER
- Financing of portfolio expansion secured through a private placement of MSEK 36 to Bure Equity
- Distribution agreement with Menarini for Kerasal Nail expanded to China
107% Growth in product sales in the second quarter compared with the year-earlier period
51% Growth in product sales of Nalox™/ Kerasal Nail™ in the second quarter
compared with the year-earlier period
TELEPHONE CONFERENCE
CEO Peter Wolpert will present the report at a teleconference today at 10:30 a.m. (CET) today, August 6 th , 2013. Telephone: +46 (0)8-506 26 900, and enter the code 409017
CEO COMMENTARY
Moberg Pharma is continuing to grow at a rapid pace. Product sales in the second quarter of the year rose 107 percent compared with the year-earlier period. In the U.S., sales performed better than expected and, for the first time, our proprietary sales accounted for the majority of revenue. Kerasal® Nail™ is now the bestselling product in its segment in the U.S with a market share of 19% increasing from 10% in the same period last year1 . The trend in Europe to date this year has been weaker than expected. We are achieving major successes in such key markets as France, Italy and the Netherlands, although overall growth in Europe is affected by intensifying competition. Increased share of proprietary sales improved our gross margin2 from 69% to 78% during the first six months.
Increased distribution of our current products
In the U.S., additional retailers, including national mass retailer Target, and regional retailers such as Meijer and Hannaford, have added our products to their shelves. Kerasal® Nail™ is now available at approximately 30 000 retail outlets in the U.S. With increased distribution and strong demand for Kerasal® Nail™, we have increased our marketing investments, which normally peak during the second quarter. We also continue to expand our network of distributors in other parts of the world. In recent months, we signed new distribution agreements for two important and emerging markets – China and Mexico – with our existing partners Menarini Asia-Pacific and Paladin Labs, respectively. The Chinese market for non-prescription products is growing rapidly and presents significant growth opportunities, but naturally also substantial challenges. Preparations for market approval in China have been initiated.
Pipeline progress
The ongoing clinical study of MOB-015, our drug candidate for the treatment of nail fungus, is continuing according to plan. Patient enrollment for the study was completed during the quarter. To strengthen our pipeline, we are continuously evaluating acquisition and in-licensing opportunities, focusing on OTC brands for the U.S. markets, but also on development projects and technologies.
Strengthened financing and resources for growth
In early July we strengthened our financial position through a private placement to Bure Equity, which enhances our freedom of scope for continued growth. Our organic sales growth will make us profitable, although individual quarters may result in losses, due to timing of marketing investments and large orders from customers and distributors. We are making significant growth investments – in our brands with marketing investments, mainly in Kerasal® Nail™ – but also in the planned expansion of the product portfolio with acquisitions and proprietary development projects. We retain our expectation of achieving profitability on a full-year basis and an EBITDA margin of 25 percent within two to four years.
Strong demand for our products, a larger geographical reach driven by new and expanded distribution agreements, and a strengthened financial position provide excellent conditions for continuing to build a different kind of pharmaceutical company. We are now ready to fuel our growth by adding brands, products and projects to our portfolio through acquisitions and in-licensing.
Peter Wolpert, CEO Moberg Pharma
2
1 SymphonyIRI, retail sales in food, drug, mass stores including Walmart, for 12 week period ending June 16, 2013
2 Excluding acquisition-related costs
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 proprietary 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 innovative drug delivery technologies that enable the company to improve the properties of proven compounds. This approach reduces time to market, development costs and risk.
Launched products
| PRODUCT | INDICATION | STATUS |
|---|---|---|
| 1) Nalox™ Kerasal Nail™ |
Damaged nails | Proprietary sales in the U.S. Launched by 10 partners in 25 markets |
| Kerasal® Ointment |
Dry and cracked feet | Proprietary sales in the U.S. Launched by 13 partners in 15 markets |
| Jointflex® | Joint and muscle pain | Proprietary sales in the U.S. Launched by 14 partners in 20 markets |
Nalox™ / Kerasal Nail™
Used to treat nail discoloration and damage caused by nail fungus or psoriasis. The product was launched in the Nordic region in autumn 2010 and quickly became market leader. The international launch is under way via a proprietary sales organization in the U.S. and ten partners that hold rights for 50 markets, including the major EU markets, Turkey and Russia. Nalox™ is patented and based on proven substances. 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.3 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 highly 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 cracked heals, calluses, foot pain and to soften and moisturize dry feet. Kerasal® contains salicylic acid, an effective agent for softening the stratum corneum, and urea (carbamide), which moisturizes the skin and helps to retain moisture in the new cell layers. The manufacturing process is patented. Several clinical studies have been published confirming the efficacy of Kerasal® for the treatment of extremely dry and damaged skin on the feet. The product is available for purchase in pharmacies and various retailers across the U.S. The product line also includes professional products for resale only by specialists.
3 The brands Nalox™ and Naloc™ are owned by the company's partners and Moberg Pharma has no ownership rights to these.
JointFlex®
JointFlex® is a topical treatment for joint and muscle pain. The products are produced using FUSOME™ technology, which improves the skin's absorption of the analgesic ingredients. Recently, the product line was expanded with JointFlex® ICE, a cooling lotion supplied in a roll-on product. The product provides long-term cooling pain relief and contains natural pain-relieving ingredients. JointFlex® has been evaluated in a placebocontrolled clinical trial of knee pain (osteoarthritis), which showed that patients experienced significant and rapid pain relief. The study also showed that the majority achieved long-term pain reduction. The product is available in the U.S.
Development projects
MOB-015
MOB-015 is a new topical treatment for onychomoycosis with fungicidal, keratolytic and emollient properties. Moberg Pharma's patent-pending formulation technology enables the delivery of high concentrations of a fungicidal substance (terbinafin) in and through nail tissue. Because MOB-015 is applied locally, the side effects that can be observed with oral treatment are avoided. Data from an earlier Phase II study has 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 to confirm the product concept and provide a basis for a Phase III study and out-licensing. In May 2013, patient enrollment in the study was completed. The study is conducted with leading expertise at Sahlgrenska University Hospital in Gothenburg, Sweden. Patients are treated for twelve months and followed for a total of fifteen months with respect to the endpoints that the FDA and EMA normally accept for nail fungus. The results of the study are expected in 2014.
BUSINESS DEVELOPMENT DURING THE FIRST SIX MONTHS
Moberg Derma became Moberg Pharma
In May, the company announced that the Swedish Companies Registration Office had accepted its application to change its corporate identity to Moberg Pharma AB (publ), in accordance with the resolution by the Annual General Meeting held on April 23, 2013. The reason for the change of name is that the operations had been broadened after the acquisition of Alterna LLC (which has been renamed Moberg Pharma North America LLC) and now also includes areas other than dermatology. However, dermatology and topical drug delivery technologies remain core areas of the company's operations.
Development of Limtop discontinued
It was announced in March that the company had decided to discontinue the development of Limtop – a pharmaceutical candidate for the treatment of actinic keratosis. Development was discontinued when the effect of the completed Phase II trial did not achieve the final target. Based on the data from the concluded study, the assessment was made that the project's commercial potential had declined and, accordingly, continued investments could no longer be justified.
Moberg Pharma and Paladin extended agreement for Kerasal Nail™ to Mexico
In May 2013, Paladin Labs Inc received exclusive rights to market and sell Kerasal Nail™ in Mexico. Moberg Pharma is responsible for the manufacturing and delivery of the product.
Patient enrollment completed in clinical study of MOB-015
Patient recruitment in the ongoing Phase II clinical trial of MOB-015 was completed during the quarter. MOB-015 is a topical formulation of terbinafine for the treatment of nail fungus (onychomycosis). The purpose of this study is to confirm the product concept of MOB-015 and provide a basis for a Phase III study and outlicensing.
SIGNIFICANT EVENTS AFTER THE END OF THE REPORTING PERIOD
Financing of portfolio expansion secured through private placement
Successful launches of Nalox™/Kerasal Nail™ in Europe and the U.S. and growing sales have resulted in a strengthened position for Moberg Pharma. The company is now approaching the next step in its growth strategy – to expand its product portfolio for marketing primarily through its own OTC sales channels in North America. It was against this background that the Board decided in July, pursuant to the authorization received at the 2013 Annual General Meeting, to issue 1,081,000 new shares with deviation from the shareholders' preferential rights to the Swedish institutional investor Bure Equity AB (publ). A prospectus was published on June 16th and can be found on Moberg Pharma's Swedish webpage. The private placement generated approximately MSEK 36 before issue costs, and is aimed at facilitating acquisitions and licensing of marketed products, as well as strengthening pipeline assets.
Following the new share issue, the company's share capital increased by SEK 108,100, resulting in a dilution of approximately 9.1 percent of the capital and votes in the company. After the share issue, Bure is the third largest shareholder in Moberg Pharma.
Distribution agreement for Kerasal® Nail™ with Menarini expanded to China
In June, the company announced that Menarini Asia-Pacific, part of the Menarini Group – one of the 40 largest global pharmaceutical companies – had been granted exclusive rights to market and sell Kerasal Nail™ in China. The companies now intend to apply for product approval in the Chinese market.
The expanded distribution agreement is based on an existing partnership between the two groups of companies, which resulted in the successful launch of the product in Italy. Menarini is a leading regional biopharmaceutical company in the Asia-Pacific region, with more than 3,500 employees in 13 markets and with a documented successful ability to launch and market brands in the health area. The Chinese pharmaceutical market is expected to continue to report strong growth, and is predicted to be the second largest pharmaceutical market in five years. Moberg Pharma believes that Menarini Asia-Pacific's in-depth insight into local market conditions makes it an ideal partner to manage the challenges existing in the Chinese market.
CONSOLIDATED REVENUE AND EARNINGS
Sales
Second quarter (April-June 2013)
In the second quarter of 2013, revenue amounted to MSEK 44.9 (24.5), up 83 percent compared with the second quarter of 2012. Product sales revenues amounted to MSEK 32.6 for Nalox™/Kerasal Nail®, MSEK 7.3 for Kerasal® and MSEK 5.0 for JointFlex®. Other operating income primarily comprised a research grant of MSEK 0.5 and exchange-rate gains of MSEK 0.2.
Sixth-month period (January-June 2013)
During the period January-June 2013 period, revenue amounted to MSEK 83.4 (55.5), up 50 percent. Adjusted for milestone payments, revenue increased 116 percent. The majority, MSEK 57.2 (38.4), derived from the strong sales growth for Nalox™/ Kerasal Nail®. Product sales revenues for Kerasal® amounted to MSEK 12.0 and for JointFlex® to MSEK 14.1. Product sales in Europe amounted to MSEK 29.8, in the U.S. to MSEK 47.1 and in the rest of the world MSEK 6.4.
| Distribution of operating income (KSEK) |
Apr-Jun 2013 |
Apr-Jun 2012 |
Jan-Jun 2013 |
Jan-Jun 2012 |
Full-year 2012 |
|---|---|---|---|---|---|
| Sales of products | 44,935 | 21,753 | 83,358 | 38,532 | 82,719 |
| Milestone payments | - | 2,750 | - | 17,000 | 29,750 |
| Revenue | 44,935 | 24,503 | 83,358 | 55,532 | 112,469 |
| Other operating income | 877 | 673 | 1,026 | 911 | 2,718 |
| Total operating income | 45,812 | 25,176 | 84,384 | 56,443 | 115,187 |
Revenue from product sales per quarter
| Revenue by channel | Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year |
|---|---|---|---|---|---|
| (KSEK) | 2013 | 2012 | 2013 | 2012 | 2012 |
| Proprietary sales | 29,973 | - | 45,672 | -, | 6,623 |
| Sales of products to distributors | 14,962 | 21,753 | 37,687 | 38,532 | 76,096 |
| Milestone payments | - | 2,750 | - | 17,000 | 29,750 |
| TOTAL | 44,935 | 24,503 | 83,358 | 55,532 | 112,469 |
| Revenue by product category | Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year |
|---|---|---|---|---|---|
| (KSEK) | 2013 | 2012 | 2013 | 2012 | 2012 |
| Nalox/Kerasal Nail, sales of products | 32,646 | 21,655 | 57,210 | 38,434 | 78,501 |
| Nalox/Kerasal Nail, milestone payments | - | 2,750 | - | 17,000 | 29,750 |
| Kerasal | 7,320 | - | 11,962 | - | 1,466 |
| Jointflex | 4,969 | - | 14,186 | - | 2,654 |
| Kaprolac | - | 98 | - | 98 | 98 |
| TOTAL | 44,935 | 24,503 | 83,358 | 55,532 | 112,469 |
| Revenue by geographical market (KSEK) |
Apr-Jun 2013 |
Apr-Jun 2012 |
Jan-Jun 2013 |
Jan-Jun 2012 |
Full-year 2012 |
|---|---|---|---|---|---|
| Europe | 12,203 | 19,728 | 29,847 | 47,468 | 84,102 |
| America | 30,963 | 4,361 | 47,086 | 7,650 | 20,275 |
| Rest of the world | 1,769 | 414 | 6,425 | 414 | 8,092 |
| TOTAL | 44,935 | 24,503 | 83,358 | 55,532 | 112,469 |
Distribution of revenue as a percentage, six-month period January – June 2013
Earnings
Second quarter (April-June 2013)
An operating loss of MSEK 6.6 (profit: 1.4) was reported for the second quarter of 2013. The cost of goods sold was MSEK 8.0 (6.4), leading to a gross margin on product sales 82 percent (70). Other operating expenses during the quarter amounted to MSEK 44.4 (17.4), with the majority comprised of selling expenses of MSEK 27.3 (5.5). The year-on-year cost increase was due to the company now having proprietary sales in the U.S. and increased marketing efforts following expanded distribution and a successful launch of Kerasal Nail, compared to the second quarter last year when the company only had sales via distributors. Selling expenses include costs for amortization of product rights totaling MSEK 1.5 (0).
Six-month period (January-June 2013)
An operating loss of MSEK 10.3 (profit: 9.3) was reported for the first six months of 2013. The cost of goods sold was MSEK 21.0 (12.0). Operating expenses, excluding the cost of goods sold, amounted to MSEK 73.7, compared with MSEK 35.1 in the year-earlier period. An accounting consequence of the acquisition is that the U.S. company was appreciated in the amount of MSEK 4.6 to fair value, which reduced earnings in a corresponding amount. Consolidated earnings were charged with MSEK 3.1 during the first quarter of 2013, while MSEK 1.5 was charged to earnings in the fourth quarter 2012.
The largest item in operating expenses comprised selling expenses, which amounted to MSEK 41.4 (11.4) for the period, a cost increase that in 2012 was attributable to the Company having proprietary sales in the U.S. and increased marketing efforts following expanded distribution and a successful launch of Kerasal Nail, compared to last year when the company only had sales via distributors. Selling expenses include costs for amortization of product rights totaling MSEK 2.9 (0).
The loss after financial items amounted to MSEK 11.8, compared with a profit of MSEK 10.3 for the January to June 2012 period. The decline in earnings was due to profit for the first six months of 2012 including milestone payments of MSEK 17.0, whereas no milestone payments were included in earnings for the first six months of 2013. An accounting appreciation pertaining to inventories in the acquired Moberg Pharma North America also had an adverse impact of MSEK 3.1 on Moberg Pharma's earnings during the period. Product sales revenues rose more than operating expenses, where product sales revenues increased 116 percent, while operating expenses (including cost of goods sold) increased 103 percent. The loss for the period after tax was MSEK 7.0 (profit: 39.4) and the total comprehensive loss was MSEK 1.9 (profit: 39.4).
FINANCIAL POSITION
Cash flow
Second quarter (April-June 2013)
Cash flow from operating activities amounted to a loss of MSEK 0.6 (profit: 15.5) for the second quarter.
Six-month period (January-June 2013)
Cash flow from operating activities amounted to a loss of MSEK 1.0 (profit: 5.8) for the January to June 2013 period. Cash and cash equivalents were MSEK 32.5 (79.5) at the end of the period.
Capital expenditure
Investments in subsidiaries relate to an additional consideration for the acquisition of Moberg Pharma North America, which was effected during the first quarter of 2013 and amounted to MSEK 16.7 (0). Investments in tangible fixed assets were MSEK 0.2 (0.3) during the January - June 2013 period. Moberg Pharma also has research and development costs that are expensed directly in the statement of comprehensive income.
Pledged assets and contingent liabilities
Moberg Pharma has no contingent liabilities. All pledged assets remain unchanged from those reported in the 2012 annual report and there have been no significant changes during the period in relation to equity in the subsidiary Moberg Pharma North America LLC.
CHANGES IN EQUITY
Shares
At the end of the period, share capital amounted to SEK 1,081,257.20 SEK (907,902), and the total number of outstanding shares was 10,812,572 (9,079,020) ordinary shares with a nominal value of SEK 0.10.
At the end of the period, in July 2013, the Board of Directors resolved, based on authorization from the 2013 Annual General Meeting, to by-pass the shareholders' preferential rights and issue 1,081,000 new shares to the Swedish institutional investor Bure Equity AB (publ). The private placement generated about MSEK 36 before issue expenses and is aimed at facilitating acquisitions and licensing marketed products, as well as assets that strengthen the Company's pipeline.
Stock options
On April 23, 2013, the Annual General Meeting of Moberg Derma AB resolved to implement a private placement of 77,096 warrants (equivalent to 77,096 shares) to the company's wholly owned subsidiary Moberg Derma Incentives AB and to introduce the employee stock option scheme 2013:1. In the employee stock option scheme 2013:1, 60,750 stock options were allotted and 16,345 warrants reserved to cover future
social security expenses for the employee stock options. The terms and conditions of the employee stock option scheme 2013:1 comply with the terms and conditions of the employee stock option scheme 2012:1, with the following exceptions: employee stock options in the 2013:1 scheme vest on June 30, 2016, the exercise price is SEK 36.77 per option and the last day for subscription is December 31, 2017. For a description of the terms and conditions of the employee stock option scheme 2012:1, refer to the 2012 annual report on page 56.
At June 30, 2013, there were a total of 654,779 warrants outstanding. If all warrants were exercised for shares, the number of shares would increase by 900,634, from 10,812,572 shares to 11,713,206 shares.
Disclosure of ownership
The Company's largest shareholders at June 28, 2013:
| Shareholders | No. of shares | % of votes and capital |
|---|---|---|
| The Baltic Sea Foundation | 2,274,179 | 21.0% |
| SIX SIS AG | 1,816,510 | 16.8% |
| JPM Chase NA | 825,652 | 7.6% |
| Wolco Invest AB | 600,000 | 5.5% |
| Försäkringsaktiebolaget, Avanza Pension | 585,305 | 5.4% |
| Mobederm AB | 530,341 | 4.9% |
| Third AP Fund | 486,000 | 4.5% |
| Handelsbanken Fonder AB Re Jpmel | 468,868 | 4.3% |
| Mohammed Al Amoudi | 438,870 | 4.1% |
| Synskadades Stiftelse | 172,201 | 1.6% |
| Others | 4,810,231 | 24.3% |
| Total | 10,812,572 | 100.0% |
ORGANIZATION
At June 30, 2013, the Moberg Pharma Group had 30 employees, of whom 67 percent were women. 21 were employed in the Parent Company, of whom 63 percent 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, marketing and administrative functions. Parent Company revenue amounted to MSEK 39.1 for the January to June 2013 period, compared with MSEK 55.5 for the same period in 2012. Operating expenses, excluding cost of goods sold, amounted to MSEK 37.2 (35.1) and loss after financial items was MSEK 7.9 (profit: 10.3). Cash and cash equivalents were MSEK 24.1 (79.4) at the end of the period.
RISK FACTORS
The development of new drugs up to registration approval and launch is a risky and capital-intensive process. Risk factors considered to be of particular relevance for Moberg Pharma's future development are linked to the results of clinical trials, regulator actions, competitors and pricing, production, partners and distributors, 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 2012 Annual Report on page 33.
Over the next 12 months, the most significant risk factors for the company are deemed to be associated with market development, integration and the results of clinical trials.
OUTLOOK
Moberg Pharma aims to create value and generate a solid return for shareholders through the profitable growth of the novel topical pharmaceuticals that are delivered to the global market. The ability to commercialize new products, enter into partnerships for its projects and to successfully develop the company's projects to market launch and sales is crucial to Moberg Pharma's future success. The company's financial objective is to attain an operating margin (EBITDA in relation to sales) of 25 percent within two to four years, while displaying continued strong growth.
In 2013, the focus will be on integrating the acquired U.S. operation, identifying further business opportunities and supporting the company's distributors to facilitate successful launches. The performance of the partnerships entered into will have a major impact on Moberg Pharma's income and cash flow. The company's assessment is that sales growth combined with profitability for the full year will continue.
| Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year | |
|---|---|---|---|---|---|
| (KSEK) | 2013 | 2012 | 2013 | 2012 | 2012 |
| Revenue | 44,935 | 24,503 | 83,358 | 55,532 | 112,469 |
| Cost of goods sold | -7,968 | -6,419 | -21,013 | -12,016 | -24,877 |
| Gross profit | 36,967 | 18,084 | 62,345 | 43,516 | 87,592 |
| Selling expenses1) | -27,284 | -5,511 | -41,446 | -11,397 | -21,977 |
| Business development and administrative expenses | -8,912 | -3,919 | -15,043 | -7,874 | -23,450 |
| Research and development expenses | -8,237 | -7,962 | -17,191 | -15,853 | -30,782 |
| Other operating income | 877 | 673 | 1,026 | 911 | 2,718 |
| Other operating expenses | - | - | - | - | -1,507 |
| Operating profit/loss (EBIT) | -6,588 | 1,365 | -10,308 | 9,303 | 12,594 |
| Interest income and similar items | 192 | 486 | 298 | 985 | 1,844 |
| Interest expense and similar items | -1,144 | -6 | -1,837 | -8 | 244 |
| Profit/loss after financial items (EBT) | -7,540 | 1,845 | -11,847 | 10,280 | 14,682 |
| Tax on profit for the period | 3,285 | -485 | 4,841 | 29,075 | 21,131 |
| PROFIT/LOSS FOR THE PERIOD | -4,255 | 1,360 | -7,006 | 39,355 | 35,813 |
| Items reclassified into the income statement | |||||
| Translation differences on foreign operations | 4,567 | - | 5,080 | - | -2,829 |
| Other comprehensive income/loss | 4,567 | - | 5,080 | - | -2,829 |
| COMPREHENSIVE INCOME/LOSS FOR THE PERIOD | 312 | 1,360 | -1,926 | 39,355 | 32,984 |
| Profit attributable to Parent Company shareholders | -4,255 | 1,360 | -7,006 | 39,355 | 35,813 |
| Profit/loss attributable to minority interests | - | - | - | - | - |
| Comprehensive income/loss attributable to Parent | 312 | 1,360 | -1,926 | 39,355 | 32,984 |
| Company shareholders | |||||
| Comprehensive income attributable to minority in terests |
- | - | - | - | - |
| Earnings/loss per share before dilution | -0.39 | 0.15 | -0.65 | 4.33 | 3.85 |
| Earnings per share after dilution2) | -0.39 | 0.15 | -0.65 | 4.32 | 3.68 |
| 1) Of which amortization of product rights | -1,457 | - | -2,910 | - | -477 |
| EBITDA | -5,063 | 1,424 | -7,270 | 9,414 | 13,307 |
| Depreciation/amortization of product rights | -1,457 | - | -2,910 | - | -477 |
| Other depreciation/amortization | -68 | -59 | -128 | -111 | -236 |
| Operating profit/loss (EBIT) | -6,588 | 1,365 | -10,308 | 9,303 | 12,594 |
| EBITDA excluding acquisition-related costs | -5,063 | 1,424 | -4,199 | 9,414 | 21,388 |
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
2) 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.
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| (KSEK) | June 30, 2013 |
June 30, 2012 |
December 31, 2012 |
|---|---|---|---|
| Assets | |||
| Intangible fixed assets | 157,804 | 250 | 155,970 |
| Tangible fixed assets | 1,346 | 727 | 1,336 |
| Financial fixed assets | 65 | 1 | 4 |
| Deferred tax assets | 27,151 | 29,075 | 22,196 |
| Total fixed assets | 186,366 | 30,053 | 179,506 |
| Inventories | 6,391 | 1,025 | 9,740 |
| Accounts receivable and other receivables | 39,854 | 25,305 | 38,093 |
| Cash and bank balances | 32,497 | 79,470 | 53,423 |
| Total current assets | 78,742 | 105,799 | 101,256 |
| TOTAL ASSETS | 265,108 | 135,852 | 280,762 |
| Equity and liabilities | |||
| Equity (attributable to Parent Company shareholders) | 176,691 | 116,541 | 178,234 |
| Long-term interest-bearing liabilities | 24,445 | - | 27,778 |
| Long-term non-interest-bearing liabilities | 15,578 | - | 14,492 |
| Current interest-bearing liabilities | 12,222 | 75 | 12,222 |
| Current non-interest-bearing liabilities | 36,172 | 19,236 | 48,036 |
| TOTAL EQUITY AND LIABILITIES | 265,108 | 135,852 | 280,762 |
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
| Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year | |
|---|---|---|---|---|---|
| (KSEK) | 2013 | 2012 | 2013 | 2012 | 2012 |
| Operating activities | |||||
| Operating profit/loss before financial items | -6,588 | 1,365 | -14,968 | 9,303 | 12,594 |
| Financial items, received and paid | -1,193 | 480 | -1,082 | 977 | 1,816 |
| Adjustments for non-cash items: | |||||
| Depreciation/amortization | 1,525 | 59 | 3,038 | 111 | 713 |
| Employee stock option costs | 167 | 202 | 466 | 399 | 851 |
| Cash flow before changes in working capital | -6,089 | 2,106 | -12,546 | 10,790 | 15,974 |
| Change in working capital | |||||
| Increase (-) / Decrease (+) in operating re ceivables and inventories |
5,172 | 11,646 | 7,512 | -8,682 | -4,034 |
| Increase (+) / Decrease (-) in operating liabili | |||||
| ties | 303 | 1,782 | 4,010 | 3,720 | -2,462 |
| CASH FLOW FROM OPERATING | -614 | 15,535 | -1,024 | 5,827 | 9,478 |
| ACTIVITIES | |||||
| Investing activities | |||||
| Net investments in equipment | -73 | -111 | -160 | -334 | -630 |
| Net investments in subsidiaries | - | - | -16,658 | - | -97,067 |
| CASH FLOW FROM INVESTING ACTIVITIES | -73 | -111 | -16,818 | -334 | -97,697 |
| Financing activities | |||||
| Borrowings (+) / Loan amortization (-) | -3,333 | -38 | -3,333 | -75 | 39,850 |
| Share issues or transaction costs | - | - | - | - | 27,740 |
| CASH FLOW FROM FINANCING ACTIVITIES | -3,333 | -38 | -3,333 | -75 | 67,590 |
| Change in cash and cash equivalents | -4,020 | 15,386 | -21,175 | 5,418 | -20,629 |
| Cash and cash equivalents at the start of the | 36,275 | 64,084 | 53,423 | 74,052 | 74,052 |
| period | |||||
| Exchange-rate difference in cash and cash equivalents |
242 | - | 249 | - | - |
| Cash and cash equivalents at the end of the period |
32,497 | 79,470 | 32,497 | 79,470 | 53,423 |
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
| Share capital |
Other capital contributions |
Translation reserve |
Accumulated deficit |
Total equity |
|
|---|---|---|---|---|---|
| (KSEK) | |||||
| January 1, 2013 - June 30, 2013 | |||||
| Opening balance, January 1, 2013 | 1,081 | 265,334 | -2,829 | -85,352 | 178,234 |
| Comprehensive income/loss | |||||
| Loss for the period | -7,006 | -7,006 | |||
| Other comprehensive income - translation differences on translation of foreign opera tions |
5,080 | 5,080 | |||
| Transactions with shareholders | |||||
| Employee stock options | 383 | 383 | |||
| CLOSING BALANCE, June 30, 2013 | 1,081 | 265,717 | 2,251 | -92,358 | 176,691 |
| January 1, 2012 - June 30, 2012 | |||||
| Opening balance, January 1, 2012 | 908 | 197,044 | 0 | -121,165 | 76,787 |
| Comprehensive income | |||||
| Results for the period | 39,355 | 39,355 | |||
| Transactions with shareholders | |||||
| Employee stock options | 399 | 399 | |||
| CLOSING BALANCE, JUNE 30, 2012 | 908 | 197,443 | 0 | -81,810 | 116,541 |
| January 1, 2012 – December 31, 2012 | |||||
| Opening balance, January 1, 2012 | 908 | 197,044 | 0 | -121,165 | 76,787 |
| Comprehensive income | |||||
| Profit for the period | 35,813 | 35,813 | |||
| Other comprehensive income – translation differences attributable to translation of for |
-2,829 | -2,829 | |||
| eign operations Transactions with shareholders |
|||||
| New share issue | 173 | 70,414 | 70,587 | ||
| Transaction costs, new share issue | -2,975 | -2,975 | |||
| Employee stock options | 851 | 851 | |||
| CLOSING BALANCE, DECEMBER 31, 2012 | 1,081 | 265,334 | -2,829 | -85,352 | 178,234 |
KEY FIGURES FOR THE GROUP
| Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year | |
|---|---|---|---|---|---|
| (KSEK) | 2013 | 2012 | 2013 | 2012 | 2012 |
| Revenue | 44,935 | 24,503 | 83,358 | 55,532 | 112,469 |
| Gross margin % | 82% | 74% | 75% | 78% | 78% |
| Gross margin on product sales %, exclud ing acquisition-related costs |
82% | 70% | 78% | 69% | 72% |
| EBITDA excluding acquisition-related costs | -5,063 | 1,424 | -4,199 | 9,414 | 21,388 |
| EBITDA % excluding acquisition-related costs | neg | 6% | neg | 17% | 19% |
| EBITDA | -5,063 | 1,424 | -7,270 | 9,414 | 13,307 |
| Operating profit/loss (EBIT) | -6,588 | 1,424 | -10,308 | 9,414 | 21,388 |
| Profit/loss after tax | 312 | 1,360 | -1,926 | 39,355 | 35,813 |
| Profit margin % | neg. | 6% | neg. | 71% | 32% |
| Total assets | 265,108 | 135,852 | 265,108 | 135,852 | 280,762 |
| Net receivables | -4,170 | 79,395 | -4,170 | 79,395 | 13,423 |
| Debt/equity ratio | 21% | 0% | 21% | 0% | 22% |
| Equity/assets ratio | 67% | 86% | 67% | 86% | 63% |
| Return on equity | -2% | 1% | -4% | 34% | 20% |
| Earnings per share, SEK | -0.39 | 0.15 | -0.65 | 4.32 | 3.68 |
| Operating cash flow per share, SEK | -0.06 | 1.71 | -0.09 | 0.64 | 0.97 |
| Equity per share, SEK | 16.34 | 12.84 | 16.34 | 12.84 | 16.48 |
| Average number of basic shares | 10,812,572 | 9,079,020 | 10,812,572 | 9,079,020 | 9,300,650 |
| Average number of diluted shares | 11,287,458 | 9,301,074 | 11,259,586 | 9,114,093 | 9,742,044 |
| Number of shares at end of period | 10,812,572 | 9,079,020 | 10,812,572 | 9,079,020 | 10,812,572 |
| Share price on the closing date, SEK | 33.00 | 28.00 | 33.00 | 28.00 | 37.30 |
| Market capitalization on the closing date, MSEK |
357 | 254 | 357 | 254 | 403 |
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 |
| Equity per share* | Profit/loss after tax divided by the average number of shares outstanding |
| Operating cash flow per share Cash flow from operating activities divided by number of shares outstanding at the end of period |
|
| 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.
| Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year | |
|---|---|---|---|---|---|
| (KSEK) | 2013 | 2012 | 2013 | 2012 | 2012 |
| Revenue | 17,651 | 24,503 | 39,099 | 55,532 | 109,467 |
| Cost of goods sold | -4,099 | -6,419 | -9,279 | -12,016 | -22,861 |
| Gross profit | 13,552 | 18,084 | 29,820 | 43,516 | 86,606 |
| Selling expenses | -4,399 | -5,511 | -10,025 | -11,397 | -19,708 |
| Business development and administrative ex penses |
-6,302 | -3,919 | -10,016 | -7,873 | -16,389 |
| Research and development expenses | -8,237 | -7,962 | -17,191 | -15,853 | -30,782 |
| Other operating income | 877 | 673 | 1,026 | 911 | 2,718 |
| Other operating expenses | - | - | - | - | -1,507 |
| Operating profit/loss | -4,509 | 1,365 | -6,386 | 9,304 | 20,938 |
| Interest income | 215 | 485 | 343 | 984 | 1,850 |
| Interest expense | -1,146 | -6 | -1,839 | -8 | 244 |
| Profit/loss after financial items | -5,440 | 1,844 | -7,882 | 10,280 | 23,032 |
| Tax on profit for the period | 1,234 | -485 | 1,753 | 29,075 | 20,952 |
| PROFIT/LOSS | -4,206 | 1,359 | -6,129 | 39,355 | 43,984 |
CONDENSED PARENT COMPANY BALANCE SHEET
| (KSEK) | June 30, 2013 | June 30, 2012 | December |
|---|---|---|---|
| 31, 2012 | |||
| Assets | |||
| Intangible fixed assets | 236 | 250 | 243 |
| Tangible fixed assets | 729 | 727 | 758 |
| Financial fixed assets | 178,107 | 101 | 178,107 |
| Deferred tax assets | 23,767 | 29,075 | 22,014 |
| Total fixed assets | 202,839 | 30,153 | 201,122 |
| Inventories | - | 1,025 | - |
| Accounts receivable and other receivables | 25,917 | 25,305 | 31,633 |
| Cash and bank balances | 24,051 | 79,376 | 50,838 |
| Total current assets | 49,968 | 105,706 | 82,471 |
| TOTAL ASSETS | 252,807 | 135,859 | 283,593 |
| Equity and liabilities | |||
| Equity | 183,287 | 116,548 | 189,212 |
| Long-term interest-bearing liabilities | 24,444 | - | 27,778 |
| Long-term non-interest-bearing liabilities | 16,750 | - | 16,250 |
| Current interest-bearing liabilities | 12,222 | 75 | 12,222 |
| Current non-interest-bearing liabilities | 16,104 | 19,236 | 38,131 |
| TOTAL EQUITY AND LIABILITIES | 252,807 | 135,859 | 283,593 |
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
| Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full-year | |
|---|---|---|---|---|---|
| (KSEK) | 2013 | 2012 | 2013 | 2012 | 2012 |
| Operating activities | |||||
| Operating profit/loss before financial items |
-4,509 | 1,365 | -6,386 | 9,304 | 20,938 |
| Financial items, received and paid | -1,195 | 479 | -1,072 | 976 | 1,822 |
| Adjustments for non-cash items: | |||||
| Depreciation/amortization | 62 | 59 | 122 | 111 | 233 |
| Employee stock option costs | -8 | 202 | 204 | 399 | 822 |
| Cash flow before changes in working capital |
-5,650 | 2,105 | -7,132 | 10,790 | 23,815 |
| Change in working capital | |||||
| Increase (-) / Decrease (+) in operating receivables and inventories |
1,409 | 11,646 | 5,898 | -8,683 | -13,988 |
| Increase (+) / Decrease (-) in operating liabilities |
369 | 1,782 | -5,476 | 3,720 | 5,672 |
| CASH FLOW FROM OPERATING ACTIVI TIES |
-3,872 | 15,534 | -6,710 | 5,827 | 15,499 |
| Investing activities | |||||
| Net investments in equipment | -73 | -111 | -86 | -334 | -479 |
| Net investments in subsidiaries | - | - | -16,658 | - | -105,731 |
| CASH FLOW FROM INVESTING ACTIVI TIES |
-73 | -111 | -16,744 | -334 | -106,210 |
| Financing activities | |||||
| Borrowings (+) / Loan amortization (-) | -3,333 | -38 | -3,333 | -75 | 39,850 |
| Share issues | - | - | - | - | 27,740 |
| CASH FLOW FROM FINANCING ACTIVITIES |
-3,333 | -38 | -3,333 | -75 | 67,590 |
| Change in cash and cash equivalents | -7,278 | 15,385 | -26,787 | 5,418 | -23,121 |
| Cash and cash equivalents at the start of the period |
31,329 | 63,991 | 50,838 | 73,959 | 73,959 |
| Cash and cash equivalents at the end of the period |
24,051 | 79,376 | 24,051 | 79,376 | 50,838 |
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 Year-end Report for 2012, 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.
"IFRS" in this document refers to the application of both IASs and IFRSs as interpretations of these standards as published by the IASB's Standards Interpretation Committee (SIC) and the International Financial Reporting Interpretations Committee (IFRIC).
The Group applies the same accounting principles and calculation methods as described in the 2012 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, 2013. These changes have not had any substantial 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 development and commercialization of medical products, the consolidated statement of comprehensive income and statement of financial position as a whole comprise one operating segment.
RELATED-PARTY TRANSACTIONS
The acquisition of Moberg Pharma North America includes additional purchase considerations that are triggered if revenue for the acquired company reaches a certain amount. If the established targets are achieved, an additional consideration of a maximum of MUSD 2.5 per period, a total of a maximum of MUSD 5, is to be paid to the sellers of Moberg Pharma North America. The targets for the first additional consideration were achieved and MUSD 2.5 was paid in the first quarter of 2013.
No other significant changes have occurred in relations and transactions with related parties.
FUTURE REPORTING DATES
Interim report for January – September 2013 November 5, 2013
FOR MORE INFORMATION, PLEASE CONTACT
Peter Wolpert, CEO, tel. +46 (0)8-522 307 00, [email protected]
For more information about Moberg Pharma's operations, please visit the company's website at www.mobergpharma.com
BOARD DECLARATION
This interim report is unaudited.
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 5, 2013
Mats Pettersson Chairman
Peter Wolpert CEO and Board member Torbjörn Koivisto Board member
Wenche Rolfsen Vice Chair
Geert Cauwenbergh Board member
George Aitken-Davies Board member
Peter Rothschild Board member
Gustaf Lindewald Board member