On October 29, 2018 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results of operations for the third quarter and first nine months of 2018, making progress on goals set for 2018 while driving global expansion of its Sample to Insight portfolio of molecular testing solutions covering the continuum from basic research to clinical healthcare (Press release, Qiagen, OCT 29, 2018, View Source [SID1234530426]).
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"QIAGEN’s results for the third quarter of 2018 affirm the solid performance our teams are delivering in an exciting year of growth. We are making great progress on building a unique and differentiated portfolio of Sample to Insight molecular testing solutions across the continuum of customer needs from basic research to clinical healthcare. QIAGEN is well-positioned to achieve the goals set for 2018 and to continue our progress toward the mid-term targets set for 2020," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. "
All customer classes and regions supported growth in the third quarter, including 9% growth at constant exchange rates in the Americas region and also 9% CER growth in Molecular Diagnostics. Our QuantiFERON latent TB test grew as planned at a 14% CER pace, and we are on track for our goal of about 20% CER growth for the full year. Growth in revenues from companion diagnostic co-development projects with pharmaceutical companies also supported gains in Molecular Diagnostics, along with high-single-digit CER growth in consumables for our QIAsymphony automation platform. We were also pleased with the Academia and Pharma customer classes maintaining good momentum, supported by the expansion of our offering for customers using next-generation sequencing (NGS) technologies. The distribution agreement with NeuMoDx, announced in September, adds two fully integrated testing platforms that offer the ease of clinical chemistry testing automation to molecular diagnostics laboratories. This agreement for outside the United States is highly synergistic with our portfolio and commercial channels. We are also excited about the footprint we are establishing for the QIAstat-Dx platform in Europe, and the potential of the syndromic testing market, and look forward to expanding the test menu and entering the U.S. in 2019. QIAGEN is emerging with the leading portfolio of new molecular diagnostic platform technologies addressing very large market opportunities: QuantiFERON, QIAstat-Dx, NeuMoDx and GeneReader. We continue to execute on QIAGEN’s strategy as a global leader in the emergence of molecular testing and diagnostics for a new era of breakthroughs driven by genomic insights."
(1) Adjusted figures exclude certain charges as detailed in accompanying reconciliation tables.
(2) Weighted number of diluted shares (Q3 2018: 235.2 m, Q3 2017: 232.7 m) (9M 2018: 233.8 m, 9M 2017: 233.4 m)
(3) Net cash provided by operating activities for 9M 2018 includes $30 million payment for pre-paid royalties for Natera partnership.
CER – Constant exchange rates (Q3 2018 CER sales: $387.7 m) (9M 2018 CER sales: $1,085.5 m) Tables may have rounding differences.
Net sales by product category and customer class
(1) Includes companion diagnostic co-development revenues (Q3 2018: $17 m, +49% CER and 9M 2018: $39 m, +54% CER) and U.S. HPV sales (Q3 2018: $6 m vs. Q3 2017: $8 m and 9M 2018: $15 m vs. 9M 2017: $19 m)
Growth rates at constant exchange rates (CER), sales and sales contributions at actual FX rates. Tables may have rounding differences.
Net sales by geographic region
Growth rates at constant exchange rates (CER), sales and sales contributions at actual FX rates. Tables may have rounding differences.
Third quarter 2018 results
Total net sales grew 3.8% at actual rates to $377.9 million in the third quarter of 2018 over the year-ago period, representing 6.5% growth at constant exchange rates that was reduced by 2.7 percentage points of adverse currency movements against the U.S. dollar. As expected, sales of the QIAstat-Dx system, acquired with STAT-Dx (in April 2018), provided less than one percentage point of incremental CER growth, while the rest of the portfolio provided a solid organic performance, also considering the adverse impact of sales associated with business changes announced in the fourth quarter of 2017 (China portfolio) and the first quarter of 2018 (veterinary assays).
Both consumables and related revenues (+6% CER / 88% of sales) and instruments (+11% CER / 12% of sales) advanced at robust rates. Molecular Diagnostics (+9% CER / 50% of sales) led the performance among the customer classes, supported by ongoing double-digit CER growth for the QuantiFERON-TB test, further expansion in Personalized Healthcare and companion diagnostic co-development agreements, and high-single-digit CER growth in consumables for use on QIAsymphony automation system. The Pharma (+5% CER / 19% of sales) and Academia (+5% CER / 22% of sales) customer classes maintained solid growth rates in light of improving trends in customer funding. Applied Testing (+1% CER / 9% of sales) grew at a mid-single-digit CER pace excluding the impact of the veterinary assays divestment.
Operating income rose to $77.0 million in the third quarter of 2018 from $63.9 million in the same period of 2017. Adjusted operating income – which excludes restructuring and other items such as business integration, acquisition-related costs, litigation costs and the amortization of intangible assets acquired in business combinations – rose 8% to $105.6 million from $97.9 million in the year-ago period. The adjusted operating income margin rose to 27.9% of sales in the quarter compared to 26.9% in the same period of 2017, with results in 2018 helped by an adjusted gross margin of 71.5% and the benefits of recent efficiency initiatives, which offset significant investments in the launch of the QIAstat-Dx system.
Net income was $60.3 million, or $0.26 per diluted share (based on 235.2 million diluted shares) compared to $48.5 million, or $0.21 per diluted share (based on 232.7 million diluted shares) in the third quarter of 2017. Adjusted net income was $81.5 million, or $0.35 per diluted share ($0.36 CER), compared to $75.5 million, or $0.32 per diluted share, in the year-ago period, with an adjusted tax rate of 19.1% in the third quarter of 2018 compared to 19.4% in the same period of 2017.
First nine months 2018 results
Total net sales grew 7.6% at actual rates to $1.1 billion in the first nine months of 2018 over the year-ago period, representing 6.4% growth at constant exchange rates, with 1.2 percentage points of positive currency movements against the U.S. dollar.
Operating income rose to $178.3 million in the first nine months of 2018 from $110.0 million in the same period of 2017. Adjusted operating income – which excludes restructuring and other items such as business integration, acquisition-related costs, litigation settlements and the amortization of intangible assets acquired in business combinations – grew 14% to $283.9 million from $249.7 million in the year-ago period. The adjusted operating income margin improved 1.4 percentage points to 25.8% of sales in the first nine months of 2018 compared to 24.4% in the same period of 2017, with an adjusted gross margin of 71.1% in the 2018 period compared to 70.7% in the year-earlier period.
Net income was $129.4 million, or $0.55 per diluted share (based on 233.8 million diluted shares) compared to $80.1 million, or $0.34 per diluted share (based on 233.4 million diluted shares) in the first nine months of 2017. Adjusted net income was $218.2 million, or $0.93 per diluted share ($0.94 CER), compared to $195.0 million, or $0.84 per diluted share, in the year-ago period, with an adjusted tax rate of 19.5% in the first nine months of 2018 compared to 18.1% in the year-ago period.
Balance sheet and cash flows
At September 30, 2018, cash and cash equivalents were $599.8 million, down from $657.7 million at December 31, 2017. Net cash provided by operating activities was $249.0 million in the first nine months of 2018 compared to $210.7 million in the same period of 2017, reflecting the improving business performance and including $30.0 million of prepaid royalties in 2018 for the Natera partnership to develop genetic assays for the GeneReader NGS System. Free cash flow was $176.7 million, up 21% from $146.1 million in the first nine months of 2017 and more than offset an increase in purchases of Property, Plant and Equipment to $72.3 million in the 2018 period compared to $64.6 million in the same period of 2017. Net cash used in investing activities was $232.6 million in the first nine months of 2018 compared to $371.9 million in the year-ago period. Net cash used in financing activities was $67.5 million compared to net cash provided by financing activities of $386.0 million in the same period of 2017, which included $726.3 million from debt issuances during 2017 that was partially offset by $304.9 million of payments in connection with the capital repayment to shareholders and share repurchase programs.
"Based on the strong sales and earnings growth to date this year, we have reaffirmed our target for about 6-7% CER sales growth and raised our guidance for adjusted EPS on a full-year basis to about $1.33-1.34 per share," said Roland Sackers, Chief Financial Officer of QIAGEN N.V. "The improving profitability comes from the solid business expansion coupled with benefits from efficiency initiatives launched in 2017, which have strengthened our competitive position, especially as we make significant investments in the launch of QIAstat-Dx and the European rollout of the fully integrated NeuMoDx platforms for molecular diagnostic testing. We continue to use our healthy financial position to strengthen our business through targeted operational investments, as well as improving returns to shareholders through our current $200 million repurchase commitment."
Highlights from our Sample to Insight portfolio
QIAGEN is focused on growth opportunities for its Sample to Insight portfolio across the continuum of molecular testing from basic research to clinical healthcare. Among recent developments:
NeuMoDx has granted QIAGEN rights to a novel, disruptive and scalable platform technology for molecular testing. This technology has been applied to next-generation automation systems for PCR (polymerase chain reaction) testing which open the important fully integrated segment of molecular diagnostics to QIAGEN. In September, QIAGEN began commercialization of the NeuMoDx 288 (high-throughput) and NeuMoDx 96 (mid-throughput) in Europe and other major markets outside the United States. QIAGEN is introducing these first two platforms, which are based on the same scalable core technology along with the first two CE-IVD marked diagnostic tests in a strategic partnership with NeuMoDx Molecular, Inc. The two companies have also entered into an agreement under which QIAGEN can acquire all remaining shares of NeuMoDx for $234 million between mid-2019 and mid-2020, subject to regulatory and operational milestones. An extensive menu of tests is in development to expand the diagnostic insights offered by the NeuMoDx systems.
QuantiFERON-TB, the gold-standard blood test for latent tuberculosis (TB) infection detection, continued to grow as authorities increasingly add screening with modern, accurate blood tests such as QuantiFERON-TB Gold Plus (QFT-Plus) to strategies for fighting TB. In September, at a United Nations meeting on tuberculosis, world leaders committed to invest $13 billion a year by 2022 for TB prevention and care. Also in September, QIAGEN and DiaSorin launched an automated, CE-marked workflow for processing QFT-Plus on DiaSorin’s widely used LIAISON immunodiagnostic instruments. Co-marketing has begun in Europe. Availability is planned for the United States in 2019 and China in 2020. Together with the previously announced Hamilton collaboration for pre-analytical sample processing, the enhanced level of workflow automation makes QFT-Plus even more unique, efficient and scalable for all settings from low-throughput laboratories to very large screening programs.
QIAstat-Dx, the powerful yet simple and highly flexible, one-step automation system for multiplex PCR analysis, is rapidly establishing a footprint in the growing market for syndromic testing. QIAGEN has launched the next-generation solution for diagnosis of complex syndromes in Europe and other markets, with the first two CE-IVD marked tests offering differential diagnosis of respiratory and gastrointestinal (GI) infections. A second GI panel was recently launched which includes comprehensive viral, bacterial and parasitic coverage. QIAstat-Dx benefits patients and saves money in healthcare with easy-to-use tests that can be analyzed rapidly, delivering results in about one hour to enable quick, accurate treatment decisions in hospitals, clinics or laboratories. QIAGEN plans to complete the FDA regulatory submission by the end of 2018 as part of plans for a U.S. launch in mid-2019.
Next-generation sequencing (NGS) continues to gain momentum from QIAGEN’s universal solutions for DNA and RNA sequencing on any platform, as well as from expanding market share of the GeneReader NGS System, the world’s first truly Sample to Insight benchtop NGS automation system. QIAGEN recently launched QIAseq FastSelect RNA Removal Kits, a breakthrough technology enabling much faster, simpler library preparation to address a bottleneck in RNA sequencing on any platform. The GeneReader NGS System is growing in placements and consumable sales, while the menu has been expanded with two new QIAact panels. One panel covers a broad range of cancer-causing variants and the other panel focuses on genes tied to breast and ovarian cancers.
In Personalized Healthcare, QIAGEN expanded its presence in developing molecular tests to support immuno-oncology (I-O), launching the NGS open-platform QIAseq TMB Panel to assess biomarkers for tumor mutation burden (TMB) that influence patient response to various immunotherapy drugs. QIAGEN Clinical Insight bioinformatics software has been expanded to interpret key I-O biomarkers. QIAGEN is the leader in co-development programs with pharmaceutical companies for personalized medicine approaches to I-O therapies. Separately, QIAGEN received FDA approval in September for the therascreen EGFR RGQ PCR Kit as a companion diagnostic to help guide the use of Pfizer’s VIZIMPRO (dacomitinib) as a first-line treatment of patients with non-small cell lung cancer (NSCLC). This is QIAGEN’s first approved companion diagnostic with Pfizer.
Update on share repurchase program
As part of a commitment to return $200 million to shareholders that was announced in January 2018, a total of 2.7 million shares have been repurchased through October 2018 on the Frankfurt Stock Exchange at a volume-weighted average price of EUR 31.43 per share for EUR 85.0 million (approximately $97 million at current exchange rates). Further information is available on the QIAGEN website (www.qiagen.com).
Outlook
QIAGEN has updated its outlook for full-year 2018, raising the target for adjusted EPS to $1.33-1.34 CER per share (previously $1.31-1.33 CER), while reaffirming expectations for sales growth of about 6-7% CER. This sales outlook includes anticipated sales of about $7 million during the second half of 2018 from the acquisition of STAT-Dx (on April 27, 2018), as well as about one percentage point of headwind from reduced U.S. HPV test sales compared to 2017. These expectations do not consider any further acquisitions that could be completed in 2018.
Based on exchange rates as of October 26, 2018, currency movements for full-year 2018 against the U.S. dollar are expected to have a negative impact of about one percentage point on 2018 net sales at actual rates, and a negative impact of about $0.02 per share on adjusted diluted EPS.
For the fourth quarter of 2018, total net sales are expected to rise about 6-7% CER, which includes about $5 million of sales from the QIAstat-Dx acquisition. Adjusted diluted EPS are expected to be about $0.39-0.40 CER.
Based on exchange rates as of October 26, 2018, currency movements against the U.S. dollar are expected to have a negative impact on net sales of about four percentage points, and a negative impact of about $0.01 per share on adjusted diluted EPS.
Quarterly results presentation, conference call and webcast details
A presentation with additional information can be downloaded at View Source A conference call will be held on Tuesday October 30, 2018, at 14:00 Central European Time (CET) / 13:00 GMT / 9:00 Eastern Standard Time (EST). (Note earlier European times due to the end of European Daylight Savings Time.) A live webcast will be made available at this website, and a replay will also be made available after the event.
Use of adjusted results
QIAGEN reports adjusted results, as well as results on a constant exchange rate (CER) basis, and other non-U.S. GAAP figures (generally accepted accounting principles), to provide additional insight into its performance. These results include adjusted gross margin, adjusted operating income, adjusted operating income margin, adjusted net income, adjusted diluted EPS, adjusted tax rates and free cash flow. Adjusted results are non-GAAP financial measures that QIAGEN believes should be considered in addition to reported results prepared in accordance with GAAP, but should not be considered as a substitute. Free cash flow is calculated by deducting capital expenditures for Property, Plant and Equipment from cash flow from operating activities. QIAGEN believes certain items should be excluded from adjusted results when they are outside of ongoing core operations, vary significantly from period to period, or affect the comparability of results with competitors and its own prior periods. Furthermore, QIAGEN uses non-GAAP and constant currency financial measures internally in planning, forecasting and reporting, as well as to measure and compensate employees. QIAGEN also uses adjusted results when comparing current performance to historical operating results, which have consistently been presented on an adjusted basis. Reconciliations are included in the tables accompanying this report.