Jun 3, 2013 Qiagen N.V. (QGEN-NASDAQ) $18.50* Note to Readers: More details to come; changes are highlighted. Except where noted, and highlighted, no other section of this report has been updated. Reason for Report: 1Q13 Earnings Prev. Ed.: Apr 22, 2013: 4Q12 & FY12 Earnings (Brokers’ materials were as of Feb 8, 2013) Brokers’ Recommendations: Neutral: 75.0% (9); Positive: 25.0% (3); Negative: 0% Brokers’ Target Price: $21.17 (↓$0.05 from the last edition; 9 firms) Prev. Ed.: 4, 8, 0 Brokers’ Avg. Expected Return: 14.4% * Note: Though dated Jun 3, 2013, share price and broker material as of May 13, 2013. Note: The tables below (Revenue, Margins, and Earnings per Share) contain material from fewer brokers than in the Valuation table. The extra figures in the Valuation table come from reports that did not have accompanying spreadsheet models. Portfolio Manager Executive Summary Qiagen N.V. (QGEN) is one of the world’s leading providers of technologies and products for the separation, purification, and handling of nucleic acids DNA/RNA. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make these isolated biomolecules visible. Of the 12 firms covering the stock, 9 firms (75.0%) assigned neutral ratings and the remaining 3 firms (25.0%) provided positive ratings. None of the firms rendered the stock negative. Neutral or equivalent outlook (9/12 firms): The neutral firms are concerned over the low guidance issued by the company. The guidance falls below the expected range of the firms. They are disappointed with the company’s projection of a decline of US HPV sales and declining trend in the Pharma and Academia growth rate. Moreover, they also fear the effects of the sequestration which will likely hit the financials of the company. On a positive note, the firms are positive over acquisition of Ingenuity Systems. The firms believe that post-acquisition, the company will strengthen its position in the nextgen sequencing (NGS) data analysis. They are further encouraged by the MDx products, which accounts for one third of the revenue. However, they are on the sideline regarding HPV products as these face pricing pressure from the contracts. Additionally, taking into account Qiagen’s 80% market share in HPV space, the firms are concerned about other recent competitive product launches, which can limit its market share gains. Their views also reflect concerns based on increased pressure in key markets, budget uncertainties in the U.S, and a decline in instrument sales leading to an overall slowdown in the market. These firms assert that industry headwinds such as tough competition, pricing pressure and lower utilization rates will continue to dampen growth in the future for Qiagen as well as its th © Copyright 2013, Zacks Investment Research. All Rights Reserved. peers. However, any increase in the company’s market share might be comforting for these firms. Therefore, they believe that Qiagen’s moderate growth rate will fail to boost investor confidence. Positive or equivalent outlook (3/12 firms): In spite of the company falling marginally short of the estimates and lowering of its guidance, positive firms are encouraged by the company’s product line in future. The firms believe that the product line will act as a catalyst for the company’s growth. Additionally, they firmly believe that the latent TB testing (QuantiFERON) and QIAsymphony uptake will continue driving the company’s revenue. The firms are also positive on KRAS tests, as well as, HPV products. Though HPV products are on a declining trend in the U.S., on an international basis, the product has been performing strongly. They expect Qiagen to exhibit further growth by QIAsymphony placements and with product offerings such as the QIAensemble series in fast growing markets. They are also encouraged with the strategic acquisitions executed by Qiagen, the most recent one being Ingenuity Systems. These firms are also bullish as they expect expansion in newer markets to drive growth in the long-term. The firms believe that after a year of underperformance compared to its competitors, the company’s cost cutting initiatives along with the potential for capital deployment will improve Qiagen’s performance going ahead. Jun 3, 2013 Overview Based in Venlo, the Netherlands, Qiagen N.V. (QGEN or the company) is a leading provider of innovative technologies and products for pre-analytical sample preparation and molecular diagnostics solutions. It has developed a comprehensive portfolio of more than 500 proprietary, consumable products, and automated solutions for sample collection. The company specializes in nucleic acid and protein handling, separation, and purification. It also supplies diagnostic kits, tests, and assays for human and veterinary molecular diagnostics. The company also offers customized services such as whole genome amplification services, deoxyribonucleic acid (DNA) sequencing, and non-cGMP DNA production on a contract basis. Qiagen has subsidiaries in the U.S., Germany, U.K., Switzerland, France, Japan, China, Australia, Canada, Norway, and several other countries with good sales potential. Qiagen has established a presence in China with about 350 employees. In 2011, it created a new subsidiary in India, one of the world’s fastest-growing healthcare markets. The company derives bulk of its revenue from Europe, the U.S, and Japan. Its website is www.qiagen.com. On May 3, 2012, Qiagen acquired Boston-based privately-owned company AmniSure International. Through the acquisition, Qiagen will have access to AmniSure’s proprietary diagnostic test AmniSure assay, which determines rupture of fetal membranes (ROM) in pregnant women. Zacks Investment Research Page 2 www.zackspro.com The analysts identified the following factors for evaluating the investment merits of Qiagen: Key Positive Arguments Key Negative Arguments The firms believe that growth will be regained by positive Qiagen experiences tough competition in various key markets uptake of the QIAsymphony RGQ instrument and the from major giants like Sigma-Aldrich corporation, Roche QIAensemble series. Diagnostics GmbH and Gen-Probe Inc. All of these competitors are in continuous process of seeking regulatory approvals for their respective products, a successful execution of which may affect growth of Qiagen. Qiagen is acquiring several companies to expand its product portfolio, the latest being Ingenuity Systems. Moreover, it creates innovative technologies to address new markets with substantial potential. These new markets include functional genomics, proteomics, molecular diagnostics, and gene therapy, which are expected to grow rapidly in the future. The gradual improvement in domestic HPV testing volume even amidst a tough macro-economic scenario is encouraging The high growth in the DNA/RNA isolation and purification market attracts a number of competitors, which could be a threat to Qiagen. The company is expanding into new markets, which in turn, could lead to substantial increase in expenses and risks. Note: The company’s fiscal references coincide with the calendar year. Jun 3, 2013 Long-Term Growth The key attraction of Qiagen's business model is the impressive resilience of its organic growth. Within Qiagen's "4 P" framework (Prevention, Profiling, Point of Care and Personalized Healthcare), HPV testing belongs to the prevention category (cervical cancer). Profiling includes amongst other things, testing for infectious diseases. Point of Care testing will help to expand into less sophisticated emerging markets and includes testing of HPV and hospital acquired infections (HAI). Personalized healthcare is an area that Qiagen is currently trying to build into an industry-leading business. Qiagen has taken advantage of its almost monopolistic position in nucleic acid handling and purification domain to drive sales growth in emerging high-growth areas such as molecular diagnostics (usually pathogen testing) and applied testing (such as forensics). The molecular diagnostics market is expected to remain the major growth driver going forward. The company’s initiatives (e.g. personalized healthcare) to build on its position in the growing molecular diagnostics market, not only strengthens its market position, but also allows it to leverage its existing global sales and marketing infrastructure. However, for the past few quarters, the company has been experiencing softer growth due to budget constraints at hospitals, looming regulatory reforms, and possible business risks surrounding gene patents. In addition, recent sales results were disappointing owing to weak organic sales growth in a challenging academic environment both in North America and Europe. Yet, the firms consider these challenges to be short lived and expect the company to gain traction in the near term. Qiagen’s long-term business strategy involves entering into strategic alliances as well as marketing and distribution arrangements with academic, corporate and other partners relating to the development, commercialization, marketing and distribution of certain existing and potential products. Qiagen has historically expanded its reach and technological portfolio through acquisitions and alliances, and is looking for continued investment in the future. Its acquisition strategy remains focused and consistent, looking to add complementary technologies, new commercial capabilities and/or extend geographical reach. Additionally, Qiagen is also working on a number of partnerships with the pharmaceutical industry, particularly in the area of oncology. The firms view Qiagen as a good long-term player in genetic analysis (research and applied markets) as well as molecular diagnostics (clinical market). Jun 3, 2013 Zacks Investment Research Page 3 www.zackspro.com Target Price/Valuation Rating Distribution Positive Neutral Negative Avg. Target Price Digest High Digest Low No. of the analyst with Target Price/Total Analyst Upside from current Maximum Upside from current Minimum Downside from current 25.0%↓ 75.0%↓ 0.00% $21.17↓ $26.00 $18.00 9/12 14.4% 40.5% 2.7% Risks to attainment of the price target include softness in customer budgets (e.g. public funding, hospital capital equipment budgets), market share erosion, and less-than-anticipated penetration in the HPV market, dilutive acquisitions, integration risks, and currency fluctuations. Recent Events On Apr 29, 2013, Qiagen reported its 1Q13 results. Highlights are as follows: The company reported EPS of $0.08 in 1Q13 compared with $0.12 in 1Q12. However, adjusted EPS came in at $0.23, flat y/y. In 1Q13, revenues increased 2% y/y to $303.6 million (up 3% at constant exchange rates or CER). For 2Q13, the company expects the adjusted net sales to grow by approximately 1-2% at CER while EPS to be around $0.25. For FY13, the company projected the adjusted net sales to grow by approximately 5% CER, while the adjusted EPS to be $1.13. The guidance includes the dilution of $0.03 per share on account of Ingenuity acquisition. This guidance can be compared to previously guided EPS range of $1.16 and $1.18. Revenue In 1Q13, Qiagen reported net revenue of $303.6 million, up 2% y/y (up 3% at CER). Growth in revenue is attributable to the growth molecular diagnostics and applied testing customer classes. However, was offset by less growth in Academia and Pharma segments. Currency movement offset the sales growth by 1 percentage point. The Zacks Digest average net revenue in 1Q13 was approximately in line with the company’s report. Zacks Investment Research Page 4 www.zackspro.com Region-wise sales In 1Q13, in terms of geographic regions, sales in the Americas grew at 2% CER. Growth in the molecular diagnostics was offset by lower sales in Academia and Pharma. Net sales in the Middle East, Africa and Europe increased 4% at CER. Growth in the region is attributable to higher sales of QuantiFERON latent TB test. Contributions were seen from Germany, the U.K., Turkey and Italy. In Asia-Pacific and Japan, sales increased 3% at CER. Double-digit growth rate was witnessed in India and China; however, sales were more or less flat in South Korea. Growth in Japan was modest singledigit. Provided below is a summary of total revenue as compiled by Zacks Digest: $ in million Digest Average Digest High Digest Low YoY Growth 1Q12A 2012A 1Q13A 2Q13E 3Q13E 4Q13E 2013E 2014E 2015E $296.4 $1,254.4 $303.7 $311.1↓ $320.7 $368.3↓ $1,304.2↓ $1,382.5↓ $1,474.6 $296.4 $1,254.5 $304.0 $313.0↓ $324.0 $374.5↓ $1,314.3↓ $1,398.0↓ $1,491.3 $296.0 $1,254.0 $303.6 $308.6↓ $317.4 $353.0↓ $1,292.0↓ $1,352.0↓ $1,455.0 12.2% 7.2% 2.5% 1.3%↓ 5.4% 6.2%↓ 4.0%↓ 6.0%↑ 6.7% Outlook: For 2Q13, the company expects the adjusted net sales to grow at approximately 1% – 2% while for FY13, the company expects revenue to increase around 5% from previously provided range of 5% and 6%. The projection of 5% sales growth includes negative affect of reduced government funding. Segment Details Qiagen’s revenues can be differentiated into Consumables and Automated Instruments. Consumables (89% of total revenues in 1Q13) Qiagen continues to expand in the consumables market by offering solutions such as plasmid DNA and RNA purification and stabilizations, genomic and viral nucleic acid purification, nucleic acid transfection, polymerase chain reaction (PCR) amplification, reverse transcription, DNA cleanup after PCR and sequencing, DNA cloning and protein purification. Its largest selling consumable product is the digene HC2 HPV Test, a signal amplified test regarded as the “gold standard” in testing for high-risk strains of the HPV, the prime cause of cervical cancer in women. Qiagen is focused on developing new products for nucleic acid-based molecular diagnostics. The company’s consumable manufacturing facilities are located in Germany, China, the UK and the U.S. Currently, Qiagen offers 500 core consumable products. Revenues from consumables increased 4% y/y at CER in 1Q13. The growth in the segment was brought about by double-digit growth in Molecular Diagnostics and robust single-digit growth in Applied Testing. Automated Instruments (11% of total revenues in 1Q13) The instruments market is widely diverse and includes analytical instruments (DNA sequencers, high throughput screening systems, mass spectrometers, and chromatography equipment) and laboratory equipment (freezers, centrifuges, water purification, and automated liquid handlers). The instrumentation systems automate the use of sample and assay techniques into efficient solutions for low, medium and high throughput scale laboratories. These systems enable customers to perform Zacks Investment Research Page 5 www.zackspro.com nucleic acid sample preparation, assay setup, target detection and other laboratory tasks. Products in this segment include QIAsymphony, Rotor-Gene Q, QIAensemble, PyroMark, QIAcube, QIAxcel and ESE-Quant Tube Scanners. The company’s instrument manufacturing facilities are located in Switzerland. Qiagen focuses on four principal segments or customer classes for sample and assay technologies, which include Molecular Diagnostics, Applied Testing, Pharma/Biotech and Academia/Government. Instrumentation revenues decreased 3% y/y at CER in 1Q13. The drop in the segment’s revenues is attributable to decline in the Pharma and low Applied Testings segments. However, the weakness was partially offset by increase in Pharma. QIAsymphony automation platform continued its strong performance. Molecular Diagnostics (50% of sales): The Molecular Diagnostics segment (50% of total sales in 1Q13) registered a 11% y/y increase in sales at CER in 1Q13. Growth in this segment brought about by double-digit growth rate in consumables, however, was offset by QIAsymphony placements. Sales of QuantiFERON-TB test for latent tuberculosis (TB) grew by robust 20% at CER in U.S. and Europe. However, weakness was brought about weak sales in HPV Testing owing to pricing pressures. Sales in HPV declined by 2% at CER. Revenues from products under Profiling increased by double-digits on the back of growth in QIAsymphony automation platforms. Applied Testing (8% of sales): The Applied Testing segment consists of forensic (including bio security), food testing and veterinarian testing where Qiagen is a market leader. The Applied Testing segment contributed 8% of total sales in 1Q13. Sales derived from applied testing were up 5% y/y at CER in 1Q13 primarily driven by strong single-digit sales growth in veterinary medicine, human identification/forensics and food safety. The European horsemeat scandal provided additional growth and awareness about benefits of molecular testing capabilities by the company’s products. Pharma/Biotech (18% of sales): Qiagen is a supplier for pharmaceutical and biotechnology companies. Drug discovery and development efforts increasingly employ genomic information, both to guide research in diseases and to differentiate the patient populations most likely to respond to particular therapies. Approximately half of Qiagen’s sales in this customer class support research, while the remaining half of sales support clinical development processes, including the stratification of patient populations based on genetic information. Qiagen’s total revenues in 1Q13 declined 4% at CER. Growth in the Asia-Pacific / Japan was offset by the low earnings in the EMEA and Americas region. Restructuring activity and site consolidation resulted in the decline of revenue. Management continues to anticipate robust growth in development-related pharmaceutical sales, offset by weak demand for research-related products. In the coming years, the company expects a wave of newly discovered biomarkers and companion diagnostics to transform the treatment of an increasing number of diseases. Academia/Government (24% of sales): Qiagen provides sample and assay technologies to leading research universities worldwide. Many academic laboratories continue to utilize manual, labor intensive methods for nucleic acid separation and purification. Recognizing the opportunity to replace traditional methods with reliable, fast, highly reproducible, and high-quality nucleic acid extraction and purification technologies, Qiagen has concentrated its product development and marketing efforts toward industry and academic research markets. Zacks Investment Research Page 6 www.zackspro.com Sales to industry and academic customer groups declined 4% y/y at CER. Decline in the growth is attributable to low sales of both consumables and instruments. The instruments and consumable sales declined on the back of concerns of reduced government funding. Fears of implementation of U.S. government sequestration, which started in March, also added to the concerns. Europe and AsiaPacific/Japan, apart from China, witnessed lower sales. The company estimates that the cut in the government funding environment might adversely affect the FY13 sales by at least 1 percentage point. Recent Updates On May 24, 2013, SIP Biotech Development Co., Ltd. (BioBAY) entered into a joint venture with QIAGEN to open QIAGEN (Suzhou) Translational Medicine Center, a translational medicine R&D Corporation. This aims to create companion diagnostics, increase discovery and validate biomarkers for the Chinese markets. Ingenuity acquisition: On Apr 29, 2013, Qiagen acquired Calif.-based privately owned company, Ingenuity Systems, Inc. Through the acquisition, Qiagen will have access to Ingenuity’s proprietary Ingenuity Knowledge Base and software applications, which is an advanced knowledge system and analysis solution for complex biomedical information. However, financial terms of the deal were not disclosed. Qiagen claims that, with the Ingenuity products, the company will be able to widen its scope in the rapidly growing market of sequencing with faster and efficient data analysis. Ingenuity stated that, while an entire human genome sequence takes only 2 days to complete, the data analysis can take months and years. However, the Ingenuity product line needs some time (may be some minutes) for data interpretation. Viewing the substantial potential of the molecular diagnostic market globally, Qiagen is currently focusing on expanding its diagnostics products offering. The company currently derives around 50% of its total revenue from this segment, which is likely to increase with this acquisition. Qiagen has acquired several companies to expand its product portfolio, the significant ones are Cellestis and Ipsogen in 2011. On Mar 30, 2013, Qiagen commercially released careHPV, approved on Nov 28, 2012, can screen for high risk human papillomavirus (HPV) under low-resource clinical settings, such as electricity, water or laboratories. On Feb 13, 2013, Qiagen entered into an agreement with Eli Lilly and Company for commercialization and development of companion diagnostics along with Lilly investigational and approved medicines throughout therapeutic areas. On Jan 7, 2013, Qiagen N.V. entered into three different agreements under which it obtained rights for RET, ROS1 and DEPDC1 from Insight Genetics for lung cancer. Through this agreement, the company will also allow the biomarkers to expand its pipeline of diagnostics for Personalized Healthcare applications. Zacks Investment Research Page 7 www.zackspro.com Provided below is a summary of segment revenue as compiled by the Zacks Digest: Revenue Segments ($ in million) Total Consumables Total Instruments Others 1Q12A 2012A 1Q13A 2Q13E 3Q13E 4Q13E 2013E 2014E 2015E $259.7 $1,084.8 $268.8 $269.8↓ $278.4 $315.5↓ $1,132.5↓ $1,201.3↓ $1,281.5 $35.7 $0.9 $169.1 $1.5 $34.8 $42.1↓ $42.5 $58.8↑ $178.1↓ $188.2↓ $197.5 Provided below is the graphical presentation of segment revenue: Please refer to the Zacks Research Digest spreadsheet on Qiagen for more extensive revenue figures. Margins In 1Q13, reported gross margin increased 5.6% y/y. As a percentage of sales it was 65.9% compared with 63.9% in 1Q12. The Zacks Digest adjusted gross margin in 1Q13 was 72.0% compared with 70.7% in 1Q12. Adjusted operating income in 1Q13 was flat y/y at CER to $78.4 million. The adjusted operating margin declined 130 bps y/y to 25.8% in 1Q13. Zacks Investment Research Page 8 www.zackspro.com The Zacks Digest operating margin in 1Q13 was 25.8% compared with 27.0% in 1Q13. Outlook: For FY13, the company expects adjusted operating margin to be 29%. Ingenuity acquisition is expected to adversely affect the adjusted operating margin by about 100 bps or 1 percentage points. Provided below is a summary of margins as compiled by Zacks Digest: Margins Gross Operating Pre-tax Net 1Q12A 70.7% 27.0% 25.6% 18.4% 2012A 71.4% 28.4% 26.4% 20.8% 1Q13A 72.0% 25.8% 23.7% 18.1% 2Q13E 71.5% 27.1%↓ 24.7%↓ 19.0%↓ 3Q13E 71.9% 27.8% 25.9% 20.1% 4Q13E 72.2% 32.3%↑ 29.1%↑ 25.1%↑ 2013E 72.0%↑ 28.7%↓ 26.5%↓ 20.8%↓ 2014E 72.1% 30.3%↑ 27.9%↑ 21.8%↓ 2015E 72.3% 29.9% 28.1% 22.4% Note: As per the Zacks Digest model, on a pro forma basis cost of goods sold (COGS) on a proforma basis, is expected to increase 2.0% y/y in FY13 and 5.5% y/y in FY14; SG&A expense (excluding ESOP) is expected to increase 4.0% y/y in FY13 and 5.1% y/y in FY14; and R&D expense is expected to increase to 12.4% y/y in FY13 and increase 4.6% y/y in FY14. In comparison, revenue is expected to increase 5.3% y/y in FY13 and 5.7% y/y in FY14. Please refer to the Zacks Research Digest spreadsheet on QGEN for more extensive margin figures. Earnings per Share Qiagen’s 1Q13 EPS of $0.08 was lower than $0.12 in 1Q12. However, adjusting for certain one-time items, EPS came in at $0.23 flat y/y. The Zacks Digest average for 1Q13, EPS was in line with the company’s report. Provided below is a summary of EPS as compiled by Zacks Digest: EPS Digest Average 1Q12A 2012A 1Q13A 2Q13E 3Q13E 4Q13E 2013E 2014E 2015E $0.23 $1.08 $0.23 $0.25↓ $0.27 $0.39↑ $1.13↓ $1.25↓ $1.36 $0.27 $0.39↑ $1.13↓ $1.26↓ $1.39 $0.27 $0.38↑ $1.12↓ $1.24↓ $1.33 Digest High $0.23 $1.08 $0.23 $0.25↓ Digest Low $0.22 $1.08 $0.23 $0.25↓ Outlook: In 2Q13, the company expects adjusted EPS to be $0.25. For FY13, the company changed the adjusted EPS to $1.13 from previously guided range of $1.16 - $1.18. The guidance takes into account $0.03 for ingenuity acquisition. The previous guidance took into account $0.01 - $0.02 per share as an impact from the U.S. medical tax and high interest expenses. Please refer to the Zacks Research Digest spreadsheet on QGEN for more extensive EPS figures. Jun 3, 2013 Zacks Investment Research Page 9 www.zackspro.com StockResearchWiki.com – The Online Stock Research Community Discover what other investors are saying about Qiagen N.V. (QGEN) at: QGEN profile on StockResearchWiki.com Analyst Varun Parekh Copy Editor Anita Ganguli Content Editor No. of brokers reported/Total brokers Reason for Update Urmimala Biswas QCA Rajiv Mukherjee Lead Analyst Urmimala Biswas Zacks Investment Research 12/12 Earnings Page 10 www.zackspro.com