Bio-Techne (TECH) 10-K risk factor changes: FY2019 vs FY2018
The 2019-06-30 10-K against the 2018-06-30 one, compared heading by heading and sentence by sentence. One of these filings carries no fiscal year tag, so its year is the calendar year of the period end.
Item 1A19 rewritten37 added5 removed193 unchanged
All filing items884 rewritten622 added413 removed1,003 unchanged
Summary
counted, not written
- Item 1A lists 26 risk factor headings: 3 new, 2 reworded and 21 unchanged since FY2018. 0 headings from FY2018 no longer appear.
- Sentence by sentence, 622 added, 413 removed, 884 rewritten and 1,003 unchanged across 18 items that differ.
New Item 1A headings (3)
- The Company could face significant monetary damages and penalties and/or exclusion from government programs if its Exosome Diagnostics’ EPI business violates federal, state, local or international laws including, but not limited to, anti-fraud and abuse laws.
- The Company’s Exosome Diagnostics EPI business could be harmed from the loss or suspension of a license or imposition of a fine or penalties under, or future changes in, or interpretations of, the law or regulations of the Clinical Laboratory Improvement Act of 1967, and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), or those of Medicare, Medicaid or government agencies where the Company operates its laboratory.
- Failure to comply with privacy and security laws and regulations could result in fines, penalties and damage to the Company’s reputation and have a material adverse effect upon the Company’s business, a risk that has been elevated with the acquisition of Exosome Diagnostics, whose laboratory testing service is a healthcare provider that obtains and uses protected health information.
Removed Item 1A headings (0)
Every FY2018 risk factor heading is still here, word for word or reworded.
Reworded Item 1A headings (2)
[removed: Over the past two][added: Several] years [added: ago] we identified and remediated material weaknesses in our internal control over financial reporting which, if recurring, could harm our operating results or cause us to fail to meet our reporting obligations.- Cyber security risks and the failure to maintain the confidentiality, integrity, and availability of our computer hardware, software, and Internet applications and related tools and
[removed: functions][added: functions,] could result in damage to our[removed: reputation][added: reputation, data integrity] and/or subject us to costs, fines, or[removed: lawsuits.][added: lawsuits under data privacy or other laws or contractual requirements.]
A heading is new when no FY2018 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
22 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2019; struck-through words were in FY2018. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS
19 rewritten, 37 added, 5 removed, 193 unchanged
It may be difficult for us to implement our strategies [removed: for revenue growth in] [added: for revenue growth in] light of competitive [removed: challenges.][added: challenges.]
Our acquisition growth strategy [removed: poses financial,] [added: poses financial,] management and other risks and challenges.
We routinely explore acquiring other businesses and assets, and have completed [removed: fifteen] [added: sixteen] acquisitions and several investments in the last [removed: six] [added: seven] years.
Further, we may not be able to integrate acquired businesses successfully into our existing businesses, make such businesses profitable, or realize anticipated cost savings or synergies, if any, from these acquisitions, which could adversely affect our [added: overall] business.
For example, the Company has an approximate [removed: 8%] [added: 7%] equity investment in publicly traded ChemoCentryx, Inc. (Nasdaq: CCXI) that is valued at [removed: $54.3] [added: $38.2] million as of June 30, [removed: 2018.][added: 2019.]
In fiscal 2018, Astute was acquired by a third party and we realized a [removed: loss] $16.2 million [added: loss] on our investment.
The U.S. administration has called for substantial changes to trade [removed: agreements, such as the North American Free Trade Agreement (NAFTA),] [added: agreements] and [removed: has imposed] [added: is imposing] significant increases on tariffs on goods imported into the United States, particularly from China.
The [added: U.S.] administration has also indicated an intention to ask Congress to make significant changes, replacement or elimination of the Patient Protection and Affordable Care Act, and government negotiation/regulation of drug prices paid by government programs.
We engage in business globally, with approximately [removed: 46%] [added: 45%] of our sales revenue in fiscal [removed: 2018] [added: 2019] coming from outside the U.S. In addition, one of our strategies is to expand geographically, particularly in China, India and in developing countries, both through distribution and through direct operations.
Our [removed: biotechnology and protein platforms] [added: Protein Sciences segment] products are sold primarily to research scientists at pharmaceutical and biotechnology companies and at university and government research institutions.
[removed: Over the past two] [added: Several] years [added: ago] we identified and remediated material weaknesses in our internal control over financial reporting which, if recurring, could harm our operating results or cause us to fail to meet our reporting obligations.
[removed: At the beginning of] [added: During] fiscal [removed: 2017] [added: 2016,] management identified material weaknesses in our internal control over financial reporting.
Cyber security risks and the failure to maintain the confidentiality, integrity, and availability of our computer hardware, software, and Internet applications and related tools and [removed: functions] [added: functions,] could result in damage to our [removed: reputation] [added: reputation, data integrity] and/or subject us to costs, fines, or [removed: lawsuits.][added: lawsuits under data privacy or other laws or contractual requirements.]
Although our computer and communications hardware are protected through physical and software safeguards, [removed: it is] [added: they are] still vulnerable to fire, storm, flood, power loss, earthquakes, telecommunications failures, physical or software break-ins, software viruses, and similar events.
As of June 30, [removed: 2018,] [added: 2019,] we owned or exclusively licensed [removed: 152] [added: over 400] granted [removed: U.S.] patents and [removed: approximately 82] pending patent applications.
In addition, certain provisions of the Tax Act including the Base Erosion Anti-abuse Tax (BEAT) and the provision designed to tax currently global intangible low-tax income (GILTI) [removed: are] [added: were] effective for the Company in the year beginning July 1, 2018.
In addition, [added: the Company anticipates] changes in interpretations, assumptions and guidance regarding the Tax [removed: Act, as well as] [added: Act to be issued by] the [removed: potential for technical corrections,] [added: U.S. Treasury Department, which] could have a material impact on our effective tax rate in future periods.
In fiscal [removed: 2018,] [added: 2019,] currency translation had [removed: a favorable] [added: an unfavorable] effect of [removed: $12.7] [added: $9.2] million on revenues due to the [removed: weakening] [added: strengthening] of the U.S. dollar relative to other currencies in which the company sells products and services.
As of August [removed: 24, 2018,] [added: 22, 2019,] the Company had drawn $330 million under the Credit Agreement.
Other countries have responded similarly, with tariffs on goods entering their countries.
This referendum has created political and economic uncertainty, particularly in the United Kingdom and the EU, and this uncertainty may last for years.
Our business could be affected during this period of uncertainty, and perhaps longer, by the impact of the United Kingdom’s referendum.
In addition, our business could be negatively affected by new trade agreements between the United Kingdom and other countries, including the United States, and by the possible imposition of trade or other regulatory barriers in the United Kingdom.
If we are unable to maintain reliable information technology systems and appropriate controls with respect to global data privacy and security requirements and prevent data breaches, we may suffer regulatory consequences in addition to business consequences.
As a global organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal and/or sensitive data in the course of our business.
For example, in the United States, individual states regulate data breach and security requirements and multiple governmental bodies assert authority over aspects of the protection of personal privacy.
European laws require us to have an approved legal mechanism to transfer personal data out of Europe, and the recently-enacted EU General Data Protection Regulation, which took effect in May 2018, imposes significantly stricter requirements in how we collect and process personal data.
Several countries, such as China and Russia, have passed laws that require personal data relating to their citizens to be maintained on local servers and impose additional data transfer restrictions.
Government enforcement actions can be costly and interrupt the regular operation of our business, and data breaches or violations of data privacy laws can result in fines, reputational damage and civil lawsuits, any of which may adversely affect our business, reputation and financial statements.
Our ExoDx _Prostate(IntelliScore),_ or EPI test, may not receive or maintain government or private reimbursement coverage for clinical laboratory testing as planned, which may have a material adverse effect upon the revenue and profits for this product line.
In August 2018, we acquired Exosome Diagnostics, which sells the EPI test, a non-invasive urine test that predicts the aggressiveness of prostate cancer.
We are currently seeking coverage decisions regarding reimbursement from both public and private payers.
However, the process and timeline for obtaining coverage decisions is uncertain and difficult to predict.
Moreover, federal and state government payers, such as Medicare and Medicaid, as well as insurers, including managed care organizations, continue to increase their efforts to control the cost, utilization and delivery of healthcare services.
From time to time, Congress considers and implements changes in Medicare fee schedules affecting reimbursement rates in conjunction with budgetary legislation.
Further, reimbursement reductions due to changes in policy regarding coverage of tests or other requirements for payment (such as prior authorization, diagnosis code and other claims edits, or a physician or qualified practitioner’s signature on test requisitions) may be implemented from time to time.
Still further, changes in third-party payer regulations, policies, or laboratory benefit or utilization management programs, as well as actions by federal and state agencies regulating insurance, including healthcare exchanges, or changes in other laws, regulations, or policies, may have a material adverse effect on revenue and earnings associated with Exosome Diagnostics’ EPI product.
The Company could face significant monetary damages and penalties and/or exclusion from government programs if its Exosome Diagnostics’ EPI business violates federal, state, local or international laws including, but not limited to, anti-fraud and abuse laws.
As a healthcare provider, the Company’s Exosome Diagnostics’ EPI business is subject to extensive regulation at the federal, state, and local levels in the U.S. and other countries where it operates.
The Company’s failure to meet governmental requirements under these regulations, including those relating to billing practices and financial relationships with physicians, hospitals, and health systems, could lead to civil and criminal penalties, exclusion from participation in Medicare and Medicaid, and possibly prohibitions or restrictions on the use of its laboratories.
While the Company believes that it is in material compliance with all statutory and regulatory requirements, there is a risk that government authorities might take a contrary position.
Such occurrences, regardless of their outcome, could damage the Company’s reputation and adversely affect important business relationships it has with third parties.
The Company’s Exosome Diagnostics EPI business could be harmed from the loss or suspension of a license or imposition of a fine or penalties under, or future changes in, or interpretations of, the law or regulations of the Clinical Laboratory Improvement Act of 1967, and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), or those of Medicare, Medicaid or government agencies where the Company operates its laboratory.
The commercial laboratory testing industry is subject to extensive U.S. regulation, and many of these statutes and regulations have not been interpreted by the courts.
CLIA extends federal oversight to virtually all clinical laboratories operating in the U.S. by requiring that they be certified by the federal government or by a federally approved accreditation agency.
The sanction for failure to comply with CLIA requirements may be suspension, revocation or limitation of a laboratory’s CLIA certificate, which is necessary to conduct business, as well as significant fines and/or criminal penalties.
In addition, the Company’s EPI business is subject to regulation under state law.
State laws may require that laboratories and/or laboratory personnel meet certain qualifications, specify certain quality controls or require maintenance of certain records.
Applicable statutes and regulations could be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that would adversely affect the Company's EPI business.
Potential sanctions for violation of these statutes and regulations include significant fines and the suspension or loss of various licenses, certificates and authorizations, which could have a material adverse effect on the Company’s EPI business.
In addition, compliance with future legislation could impose additional requirements on the Company, which may be costly.
Failure to comply with privacy and security laws and regulations could result in fines, penalties and damage to the Company’s reputation and have a material adverse effect upon the Company’s business, a risk that has been elevated with the acquisition of Exosome Diagnostics, whose laboratory testing service is a healthcare provider that obtains and uses protected health information.
If the Company does not comply with existing or new laws and regulations related to protecting the privacy and security of personal or health information, it could be subject to monetary fines, civil penalties or criminal sanctions.
In the U.S., the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security regulations, including the expanded requirements under U.S. Health Information Technology for Economic and Clinical Health Act (HITECH), establish comprehensive standards with respect to the use and disclosure of protected health information (PHI) by covered entities, in addition to setting standards to protect the confidentiality, integrity and security of PHI.
HIPAA restricts the Company’s ability to use or disclose PHI, without patient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policy purposes and other permitted purposes outlined in the privacy regulations.
If the laboratory operations for the Company’s EPI business use or disclose PHI improperly under these privacy regulations, they may incur significant fines and other penalties for wrongful use or disclosure of PHI in violation of the privacy and security regulations, including potential civil and criminal fines and penalties
| --- | --- | --- |
Subsequently, on March 29, 2017, the UK invoked Article 50 of the Lisbon Treaty to formally begin the withdrawal process.
The impact of this action has caused and may continue to cause global economic uncertainty and currency exchange rate fluctuations.
Although it is unknown what the terms of the UK’s future relationship with the EU will be, it is possible that there will be disruption to the UK and EU economies, as well as greater restrictions on imports and exports between the UK and the EU and increased regulatory and tax complexities.
We are still analyzing certain aspects of the Tax Act and refining our calculations, which could potentially affect the measurement of our deferred tax balances and the amount of the repatriation toll charge liability, and ultimately cause us to revise our initial estimates in future periods.
Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
102 rewritten, 74 added, 82 removed, 184 unchanged
Bio-Techne develops, manufactures and sells [removed: biotechnology products] [added: life science reagents, instruments] and [added: services for the research and] clinical diagnostic [removed: controls] [added: markets] worldwide.
[removed: After adjusting for the impacts of the Trevigen, Atlanta Biologicals and Eurocell acquisitions in fiscal 2018, as well as foreign currency fluctuations, organic] [added: Organic] sales for the year increased 9% with currency translation contributing 2% and acquisitions contributing 3%.
For fiscal [removed: 2017,] [added: 2019,] consolidated net sales increased [removed: 13%] [added: 11%] as compared to fiscal [removed: 2016.][added: 2018.]
[removed: After adjusting] [added: Organic growth] for the [removed: impacts of the Space and Advanced Cell Diagnostics (ACD) acquisitions in fiscal 2017, as well as foreign currency fluctuations, organic sales] [added: segment was 13%] for the [removed: year increased 6%] [added: fiscal year,] with [added: acquisitions contributing 2% and foreign] currency translation having [removed: a negative] [added: an unfavorable] impact of [removed: 1% and acquisitions contributing 8%.][added: 2%.]
Consolidated GAAP net earnings decreased [removed: 27%] [added: 24%] for fiscal [removed: 2017] [added: 2019] as compared to fiscal [removed: 2016.][added: 2018.]
After adjusting for acquisition related costs, stock-based compensation, and certain income tax items in both years, adjusted net earnings increased [removed: 4%] [added: 2%] in fiscal [removed: 2017] [added: 2019] as compared to fiscal [removed: 2016.][added: 2018.]
Adjusted earnings growth was driven by [removed: strong] volume leverage, which was [added: partially] offset by negative [removed: mix and a negative impact from foreign currency translation.][added: margin acquisitions.]
| Organic sales growth | | | [removed: 9] [added: 10] | % | | | [removed: 6] [added: 9] | % | | | 6 | % |
| Acquisitions sales growth | | | [removed: 3] [added: 2] | % | | | [removed: 8] [added: 3] | % | | | [removed: 6] [added: 8] | % |
| Impact of foreign currency fluctuations | | | [removed: 2] [added: (1] | [removed: %] [added: )%] | | | [removed: (1] [added: 2] | [removed: )%] [added: %] | | | [removed: (2] [added: (1] | )% |
| Consolidated net sales growth | | | [removed: 14] [added: 11] | % | | | [removed: 13] [added: 14] | % | | | [removed: 10] [added: 13] | % |
| | | [removed: __201__8__] [added: __201__9__] | | | | [removed: __2017__] [added: __201__8__] | | | | [removed: __201__6__] [added: __201__7__] | | |
| Intersegment | | | [removed: (536] [added: (827] | ) | | | [removed: (104] [added: (536] | ) | | | [removed: (125] [added: (104] | ) |
| Consolidated net sales | | $ | [removed: 642,993] [added: 714,006] | | | $ | [removed: 563,003] [added: 642,993] | | | $ | [removed: 499,023] [added: 563,003] | |
In fiscal 2018, [removed: Biotechnology] [added: Protein Sciences] segment net sales increased [removed: 16%] [added: 15%] compared to fiscal 2017.
Organic growth for the segment was [removed: 9%] [added: 10%] for the fiscal year, with acquisitions contributing [removed: 4%] [added: 2%] and foreign currency translation [removed: having a favorable impact of] [added: contributing] 3%.
In fiscal 2018, [removed: the Protein Platforms] [added: Diagnostics & Genomics] segment net sales increased [removed: 22%] [added: 12%] compared to fiscal 2017.
Organic growth for the [removed: segment] [added: year] was [removed: 20%] [added: 10%] with [removed: foreign] currency translation having [removed: a favorable] [added: an unfavorable] impact of [added: 1% and acquisitions contributing] 2%.
In fiscal [removed: 2018,] [added: 2019, the] Diagnostics [added: and Genomics] segment net sales increased [removed: 3%] [added: 7%] compared to fiscal [removed: 2017.][added: 2018.]
Organic growth for the segment was [removed: 1%] [added: 4%] with acquisitions contributing [removed: 2%.][added: 3%.]
In fiscal [removed: 2017, Biotechnology] [added: 2019, Protein Sciences] segment net sales increased [removed: 15%] [added: 13%] compared to fiscal [removed: 2016.][added: 2018.]
Consolidated gross margins were [added: 66.3%,] 67.2%, [removed: 66.5%] and [removed: 67.5%] [added: 66.5%] in fiscal [removed: 2018, 2017] [added: 2019, 2018] and [removed: 2016,] [added: 2017,] respectively.
Consolidated gross margins were negatively impacted as a result of purchase accounting related to inventory and intangible assets acquired during fiscal [added: 2019,] 2018, [removed: 2017, 2016] [added: 2017] and prior years.
Excluding the impact of acquired inventory sold and amortization of intangibles, adjusted gross margins were 71.5%, [removed: 71.2%] [added: 71.5%,] and [removed: 70.8%] [added: 71.2%] in fiscal [removed: 2018, 2017] [added: 2019, 2018] and [removed: 2016,] [added: 2017,] respectively.
| Consolidated gross margin percentage | | | [removed: 67.2] [added: 66.3] | % | | | [removed: 66.5] [added: 67.2] | % | | | [removed: 67.5] [added: 66.5] | % |
| Costs recognized upon sale of acquired inventory | | | [removed: 0.4] [added: 0.5] | % | | | [removed: 0.6] [added: 0.4] | % | | | [removed: 1.1] [added: 0.6] | % |
| Amortization of intangibles | | | [removed: 3.9] [added: 4.7] | % | | | [removed: 4.1] [added: 3.9] | % | | | [removed: 2.2] [added: 4.1] | % |
| Non-GAAP adjusted gross margin percentage | | | 71.5 | % | | | [removed: 71.2] [added: 71.5] | % | | | [removed: 70.8] [added: 71.2] | % |
Management uses adjusted operating results to monitor and evaluate performance of the Company’s [removed: three business] [added: two] segments.
The [added: small] decrease in the [removed: Biotechnology] [added: Protein Sciences] segment’s gross margin percentage for fiscal [removed: 2018] [added: 2019] was primarily attributable to mix of product sales made in this segment.
The [removed: improvements in the Protein Platforms and] Diagnostics [added: and Genomics segment] gross margin percentages for fiscal 2018 as compared to fiscal 2017 were [removed: due to] [added: positively impacted by] higher volume leverage and operational productivity.
Selling, general and administrative expenses increased [removed: $40.2] [added: $23.7] million [removed: (20%)] [added: (10%)] and [removed: $59.6] [added: $40.2] million [removed: (42%)] [added: (20%)] in fiscal [removed: 2018] [added: 2019] and [removed: 2017,] [added: 2018,] respectively.
| | | [removed: __2018__] [added: __201__9__] | | | | [removed: __201__7__] [added: __201__8__] | | | | [removed: __201__6__] [added: __201__7__] | | |
| Total segment expenses | | | [removed: 159,904] [added: 197,159] | | | | [removed: 133,743] [added: 159,904] | | | | [removed: 105,381] [added: 133,743] | |
| Amortization of intangibles | | | [removed: 21,650] [added: 25,210] | | | | [removed: 21,328] [added: 21,650] | | | | [removed: 18,300] [added: 21,328] | |
| Acquisition related expenses | | | [removed: 24,429] [added: 2,282] | | | | [removed: 25,789] [added: 24,429] | | | | [removed: 2,761] [added: 25,789] | |
| Restructuring costs | | | [removed: 376] [added: \-] | | | | [removed: \-] [added: 376] | | | | \- | |
| Stock-based compensation | | | [removed: 28,240] [added: 33,057] | | | | [removed: 14,631] [added: 28,240] | | | | [removed: 9,430] [added: 14,631] | |
| Corporate selling, general and administrative expenses | | | [removed: 6,037] [added: 6,651] | | | | [removed: 4,952] [added: 6,037] | | | | [removed: 5,007] [added: 4,952] | |
| Total selling, general and administrative expenses | | $ | [removed: 240,636] [added: 264,359] | | | $ | [removed: 200,443] [added: 240,636] | | | $ | [removed: 140,879] [added: 200,443] | |
With our deep product portfolio and application expertise, we sell integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression of specific diseases.
Our products aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses.
During our fiscal year 2019, we operated with two reporting segments – our Protein Sciences segment and our Diagnostics and Genomics segment.
Our Protein Sciences segment is a leading developer and manufacturer of high-quality purified proteins and reagent solutions, most notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents and T-Cell activation technologies.
This segment also includes protein analysis solutions that offer researchers efficient and streamlined options for automated western blot and multiplexed ELISA workflow.
Our Genomics and Diagnostics segment develops and manufactures diagnostic products, including FDA-regulated controls, calibrators, blood gas and clinical chemistry controls and other reagents for OEM and clinical customers, as well as a portfolio of clinical molecular diagnostic oncology assays, including the ExoDx®_Prostate(IntelliScore)_ test (EPI) for prostate cancer diagnosis.
This segment also manufactures and sells advanced tissue-based in-situ hybridization assays (ISH) for research and clinical use.
The organic growth was broad-based with double digit organic growth in the United States, high single digit organic growth in Europe, and over 25% organic growth in China.
| Protein Sciences | | $ | 543,159 | | | $ | 482,378 | | | $ | 419,365 | |
| Diagnostics and Genomics | | | 171,674 | | | | 161,151 | | | | 143,742 | |
Growth was broad-based and especially strong in the antibodies and cell therapy consumables as well as the Simple Western and Simple Plex instrument product categories.
Growth in this segment was primarily driven by strong RNAscope product sales.
Organic growth was 9% with acquisitions and foreign currency impacting revenue by 2% and 1%, respectively.
| | | __201__9__ | | | | __201__8__ | | | | __201__7__ | | |
| | | __201__9__ | | | | __201__8__ | | | | __201__7__ | | |
| Protein Sciences | | | 73.9 | % | | | 74.1 | % | | | 75.4 | % |
| Diagnostics and Genomics | | | 41.8 | % | | | 46.3 | % | | | 40.6 | % |
The decrease in the Diagnostics and Genomics gross margin percentages for fiscal 2019 as compared to fiscal 2018 were due to negative gross margins for acquisitions made in the segment, namely ExosomeDx.
The Protein Sciences segment decrease for fiscal 2018 as compared to fiscal 2017 was primarily attributable to mix of product sales made in this segment.
The increase in fiscal 2019 was primarily driven by an additional cost base from our fiscal 2019 acquisitions, additional stock-based compensation expense, and additional amortization expense associated with intangible assets recorded from our fiscal 2019 acquisitions.
These increases were partially offset by a reduction in acquisition related expenses.
| | | __201__9__ | | | | __201__8__ | | | | __201__7__ | | |
| Protein Sciences | | $ | 135,513 | | | $ | 119,649 | | | $ | 100,881 | |
| Diagnostics and Genomics | | | 61,646 | | | | 40,255 | | | | 32,862 | |
The increase in research and development expense in fiscal 2019 as compared to fiscal 2018 was primarily attributable to our ExosomeDx acquisition.
| | | __201__9__ | | | | __201__8__ | | | | __201__7__ | | |
| Protein Sciences | | $ | 40,735 | | | $ | 40,996 | | | $ | 41,334 | |
| Diagnostics and Genomics | | | 21,678 | | | | 14,095 | | | | 12,180 | |
Net interest expense in fiscal 2019 increased due to a change in our average long-term debt outstanding for fiscal 2019.
| | | __201__9__ | | | | __201__8__ | | | | __201__7__ | | |
During fiscal 2019, the company recognized losses of $16.1 million related to unrealized changes in fair value related to changes in the stock price of our ChemoCentryx, Inc. (CCXI) investment, which were partially offset by a $3.7 million gain realized upon acquisition from our historical investment in B-MoGen.
The change in the effective tax rate was driven by discrete tax items.
The Company's discrete tax benefits in fiscal 2019 primarily related to share-based compensation excess tax benefits of $7.2 million, $3.2 million related to deductible acquisition payments made to employees and third parties, and 2.0 million for tax refunds relating to certain state apportionments.
In fiscal 2018, the Company recognized net discrete tax benefits of $34.4 million.
The primary driver in fiscal 2018 discrete tax benefits was a discrete net tax benefit of $33.0 million related to the Tax Act (as described in Note 11).
The Company's effective income tax rate was (0.2%) in fiscal 2018 compared to 32.0% in fiscal 2017.
The primary driver of discrete items was the net tax benefit of $33.0 million related to the Tax Act discussed above recorded in fiscal 2018.
| | | __201__9__ | | | | __201__8__ | | | | __201__7__ | | |
| Restructuring costs | | | | | | | 376 | | | | \- | |
| Stock-based compensation | | | 33,057 | | | | 28,240 | | | | 14,631 | |
With our deep product portfolio and application expertise, Bio-Techne is a leader in providing specialized proteins, including cytokines and growth factors, and related immunoassays, small molecules and other reagents to the research, diagnostics and clinical controls markets.
Bio-Techne operates worldwide with three reportable business segments, Biotechnology, Protein Platforms, and Diagnostics, all of which service the life science and diagnostics markets.
The Biotechnology reporting segment provides consumables used for conducting laboratory experiments by both industry and academic scientists within the biotechnology and biomedical life science fields including proteins, antibodies, immunoassays, flow cytometry products, intracellular signaling products, and biologically active chemical compounds.
The Protein Platforms reporting segment develops and commercializes proprietary systems and consumables for protein analysis.
The Diagnostics reporting segment reporting segment provides a range of controls and calibrators used with diagnostic equipment and as proficiency testing tools, as well as other reagents incorporated into diagnostic kits.
The organic growth was broad-based, with the Company achieving growth in all three of its reporting segments.
A strong Bio-Pharma end-market in the US and Europe and additional market demand for Protein Platforms instruments were the biggest contributing factors to organic growth.
| | | __2018__ | | | | __2017__ | | | | __2016__ | | |
| | | | | | | | | | | | | |
| Biotechnology | | $ | 421,536 | | | $ | 364,504 | | | $ | 317,340 | |
| Protein Platforms | | | 111,885 | | | | 91,464 | | | | 77,324 | |
| Diagnostics | | | 110,108 | | | | 107,139 | | | | 104,484 | |
Continued strength from ACD, a fiscal 2017 acquisition, and the proteins and assays product categories drove growth.
Growth was broad-based and led by continued market demand for Simple Western (Wes) instruments and consumables and the Simple Plex (Ella) product lines.
Organic growth for the segment was 4% for the fiscal year, with acquisitions contributing 13% and foreign currency translation having an unfavorable impact of 2%.
In fiscal 2017, the Protein Platforms segment net sales increased 18% compared to fiscal 2016.
Organic growth for the segment was 19% with acquisitions contributing 1% and foreign currency translation having an unfavorable impact of 2%.
Growth was broad-based and led by additional market demand for Simple Western (Wes) instruments and consumables, and the Simple Plex (Ella) and Biologics (Maurice) product lines.
In fiscal 2017, Diagnostics segment net sales increased 3% compared to fiscal 2016.
All results for fiscal 2017 were organic.
Timing of OEM orders had a negative impact on fiscal 2017 results.
Mid-single digit sales growth in blood and glucose-based controls was partially offset by the timing of OEM shipments from the diagnostic assay and reagent product lines.
| Biotechnology | | | 79.4 | % | | | 80.5 | % | | | 80.0 | % |
| Protein Platforms | | | 69.6 | % | | | 67.6 | % | | | 67.8 | % |
| Diagnostics | | | 43.5 | % | | | 42.3 | % | | | 44.8 | % |
The Biotechnology improvement for fiscal 2017 as compared to fiscal 2016 was primarily attributable to higher volume leverage and operational productivity.
The Diagnostics and Protein Platforms segment gross margin percentages for fiscal 2017 as compared to fiscal 2016 were negatively impacted by lower volume leverage and margin mix of product sales.
The increase in fiscal 2017 was driven by additional expenses associated with the Space, ACD and Zephyrus acquisitions including $21.1 million of selling, general and administrative expenses, a $3.0 million increase in acquisition intangible amortization, a $18.4 million change in the fair value of contingent consideration and a $4.6 million increase in other acquisition related costs.
The remaining increase in selling, general and administrative expenses in fiscal 2017 was primarily due to additional investments in global commercial resources, administrative infrastructure, including increased stock compensation, and annual wage, salary and benefit increases.
| Biotechnology | | $ | 99,655 | | | $ | 82,801 | | | $ | 58,414 | |
| Protein Platforms | | | 44,475 | | | | 37,735 | | | | 34,186 | |
| Diagnostics | | | 15,774 | | | | 13,207 | | | | 12,781 | |
| | | __2018__ | | | | __201__7__ | | | | __2016__ | | |
| Biotechnology | | $ | 35,895 | | | $ | 35,507 | | | $ | 26,981 | |
| Protein Platforms | | | 15,348 | | | | 14,424 | | | | 14,610 | |
| Diagnostics | | | 3,848 | | | | 3,583 | | | | 3,596 | |
Net interest expense in fiscal 2017 increased due to the new revolving credit facility the Company entered into in July 2016 to help fund the acquisition of ACD.
The effective rate for June 30, 2018 decreased by 32.2% compared to the prior year.
This net tax benefit consisted of $36.5 million due to the re-measurement of the Company’s deferred tax accounts to reflect the U.S. federal corporate tax rate reduction impact to our net deferred tax balances offset by expense for the repatriation tax of $3.3 million.
The effective rate for June 30, 2017 increased by 2.8% compared to the prior year.
An excerpt. Shown here: 40 of 102 rewritten, 40 of 74 added and 40 of 82 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL in the FY2019 filing and the FY2018 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES
16 rewritten, 1 added, 1 removed, 16 unchanged
Approximately [removed: 28%] [added: 27%] of the Company's consolidated net sales in fiscal [removed: 2018] [added: 2019] were made in foreign currencies, including [removed: 15%] [added: 13%] in euro, [removed: 5%] [added: 4%] in British pound sterling, [removed: 3%] [added: 4%] in Chinese yuan and the remaining [removed: 5%] [added: 6%] in other currencies.
| High | | $ | [removed: 1.24] [added: 1.17] | | | $ | [removed: 1.14] [added: 1.24] | | | $ | [removed: 1.13] [added: 1.14] | |
| Low | | | [removed: 1.16] [added: 1.12] | | | | [removed: 1.05] [added: 1.16] | | | | [removed: 1.10] [added: 1.05] | |
| Average | | | [removed: 1.20] [added: 1.14] | | | | [removed: 1.09] [added: 1.20] | | | | [removed: 1.12] [added: 1.09] | |
| High | | $ | [removed: 1.42] [added: 1.32] | | | $ | [removed: 1.32] [added: 1.42] | | | $ | [removed: 1.48] [added: 1.32] | |
| Low | | | [removed: 1.29] [added: 1.27] | | | | [removed: 1.22] [added: 1.29] | | | | [removed: 1.33] [added: 1.22] | |
| Average | | | [removed: 1.35] [added: 1.29] | | | | [removed: 1.27] [added: 1.35] | | | | [removed: 1.42] [added: 1.27] | |
| High | | $ | [removed: 0.16] [added: 0.15] | | | $ | [removed: 0.15] [added: 0.16] | | | $ | 0.15 | |
| Low | | | [removed: 0.15] [added: 0.14] | | | | [removed: 0.14] [added: 0.15] | | | | [removed: 0.15] [added: 0.14] | |
| High | | $ | [removed: 0.81] [added: 0.77] | | | $ | [removed: 0.77] [added: 0.81] | | | $ | [removed: 0.78] [added: 0.77] | |
| Low | | | [removed: 0.76] [added: 0.74] | | | | [removed: 0.73] [added: 0.76] | | | | [removed: 0.71] [added: 0.73] | |
| Average | | | [removed: 0.79] [added: 0.76] | | | | [removed: 0.75] [added: 0.79] | | | | [removed: 0.76] [added: 0.75] | |
The effects of a hypothetical simultaneous 10% appreciation in the U.S. dollar from June 30, [removed: 2018] [added: 2019] levels against the euro, British pound sterling, Chinese yuan and Canadian dollar are as follows (in thousands):
| Decrease in translation of [removed: 2018] [added: 2019] earnings into U.S. dollars | | $ | [removed: 3,750] [added: 3,810] | |
| Decrease in translation of net assets of foreign subsidiaries | | | [removed: 40,782] [added: 43,242] | |
| Additional transaction losses | | | [removed: 1,928] [added: 4,484] | |
| | | __201__9__ | | | | __201__8__ | | | | __201__7__ | | |
| | | __2018__ | | | | __2017__ | | | | __201__6__ | | |
Item 1. BUSINESS
91 rewritten, 47 added, 45 removed, 106 unchanged
Bio-Techne and its subsidiaries, collectively doing business as Bio-Techne Corporation (Bio-Techne, we, our, us or the [removed: Company)] [added: Company),] develop, manufacture and sell [removed: biotechnology] [added: life science] reagents, instruments and services for the research and clinical diagnostic markets worldwide.
During our fiscal year [removed: 2018,] [added: 2019,] we operated with [removed: three] [added: two] reporting segments – our [removed: Biotechnology,] Protein [removed: Platforms] [added: Sciences segment] and [added: our] Diagnostics [removed: Divisions.][added: and Genomics segment.]
We [removed: originally] were founded over forty years ago, in 1976, as Research and Diagnostic Systems, Inc. We became a publicly traded company in 1985 through a merger with Techne Corporation, now Bio-Techne Corporation.
Our common stock is listed on the NASDAQ under the symbol “TECH.” We operate globally, with offices in [removed: multiple] [added: many] locations [removed: in the United States, Europe,] [added: throughout North America, Europe] and Asia.
[removed: Beginning in 2012, and accelerating over] [added: Over] the last [removed: three] [added: six] years, we implemented a [added: disciplined] strategy to accelerate growth in part by acquiring businesses and product portfolios that leveraged and diversified our existing product lines, filled portfolio gaps with differentiated high growth businesses, and expanded our geographic scope.
Recognizing the importance of an integrated, global approach to meeting our mission and accomplishing our strategies, we have [removed: over] [added: maintained many of] the [removed: past several years unified our] brands [removed: and recent acquisitions] [added: of the companies we have acquired, but unified] under a single global [removed: brand,] [added: brand --] Bio-Techne.
[removed: _Continued_ _innovation_ _in_ _core_ _products._] [added: _Continued innovation in core products._] Through collaborations with key opinion leaders, participation in scientific discussions and societies, and leveraging our internal [removed: talent] [added: talent,] we expect to be able to convert our continued significant investment in our research and development activities to be first-to-market with quality products that are at the leading edge of life science researchers’ [removed: needs.][added: needs, including expansion of our assay portfolios and products for cancer diagnostics and therapeutics.]
_Market [removed: and_ _geographic_ _expansion__._] [added: and geographic expansion._] We will continue to expand our sales staff and distribution channels globally in order to increase our global presence and make it easier for customers to transact with us.
We will also leverage our existing portfolio to expand our product offerings into novel research fields and further into diagnostics and therapeutics [removed: markets.][added: markets, including in cell and gene therapy.]
[removed: _Talent_ _recruit__m__ent_ _and_ _retention._] We strive to recruit, train and retain the most talented [removed: staff to] [added: staff, who will live out those epic ideals and] implement [removed: all of] our strategies effectively.
_Targeted acquisitions and investments._ We will continue to leverage our strong balance sheet to gain access to new [added: and differentiated] technologies and products that improve our competitiveness in the current market, meet customers’ expanding work flow needs and allow us to enter adjacent [added: markets, and to make investments in key technologies and product lines such as the manufacture of GMP grade reagents to support rapidly expanding immunotherapy] markets.
In fiscal [removed: 2018,] [added: 2019,] net sales from Bio-Techne’s [removed: Biotechnology,] Protein [removed: Platforms] [added: Sciences] and Diagnostics [added: and Genomics] segments represented [removed: 66%, 17%,] [added: 76%] and [removed: 17%] [added: 24%] of consolidated net sales, respectively.
Financial information relating to Bio-Techne’s segments is incorporated herein by reference to Note [removed: 11] [added: 12] to the Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.
[removed: _Biotechnology Segment_ _Products_][added: _Protein Sciences Segment Products_]
Our combined chemical and biological reagents portfolio provides high quality tools [removed: which] [added: that] customers can use in solving the [removed: complexity of important] [added: complex] biological pathways and glean knowledge that may lead to a more complete understanding of biological processes, and, ultimately, to the development of novel [added: therapeutic] strategies to address different pathologies.
[removed: Additionally, a] [added: A] number of our products have [added: been demonstrated to have] the potential to serve as predictive biomarkers and therapeutic targets for a variety of human diseases and conditions including cancer, autoimmunity, diabetes, hypertension, obesity, inflammation, neurological disorders, and kidney failure.
In addition to being useful research tools, our RNA _in situ_ hybridization assays have diagnostics applications as well, and several are currently [removed: being cleared with] [added: under review by] the FDA in partnership with diagnostics instrument manufacturers and pharmaceutical companies.
[removed: _Biotechnology Segment_ _Customers] [added: _Protein Sciences_ _Segment Customers] and Distribution Methods_
We sell our [removed: Biotechnology] products directly to customers who are primarily located in North America, Europe and China.
Our sales are widely distributed, and no single end-user customer accounted for more than 10% of [removed: Biotechnology's] [added: the Protein Sciences segment's] net sales during fiscal [removed: 2018, 2017] [added: 2019, 2018] or [removed: 2016.][added: 2017.]
[removed: _Biotechnology Segment_ _Competitors_][added: _Protein Sciences Segment Competitors_]
[removed: A] [added: With respect to the Reagent Solutions division of this segment, a] number of [added: large] companies supply the worldwide market for protein-related and chemically-based research and diagnostic reagents, including [removed: GE Healthcare Life Sciences,] BD Biosciences, Merck KGaA/EMD Chemicals, Inc., PeproTech, Inc., Abcam plc., and Thermo Fisher Scientific, [removed: Inc. Market success is primarily dependent upon product quality, selection, price and reputation.][added: Inc, as well as a number of smaller, niche competitors.]
We further believe that the expansion of our product offering, the recognized quality of our products, and the [removed: continued demand for protein-related] [added: ability to continue to bring novel, cutting edge products] and [removed: chemically-based research reagents] [added: solutions to the market] will allow us to remain competitive in the growing biotechnology [removed: research] [added: research, diagnostic,] and [removed: diagnostic] [added: therapeutics] markets.
We are not dependent on key or sole source suppliers for most of our products in the [removed: Biotechnology] [added: Protein Sciences] segment.
Our [removed: _in situ_ hybridization and] chemical-based small molecule products are synthesized from widely available products.
We typically have several outside sources for all critical raw materials necessary for the manufacture of our [removed: products.][added: products in this division.]
The majority of our [removed: Biotechnology] [added: Reagent Solutions division] products are shipped within one day of receipt of the customers' [removed: orders.][added: orders, while most of our Analytical Solutions products are shipped within one to two weeks of receipt of an order.]
[removed: Consequently, we had] [added: There was] no significant backlog of orders for our [removed: Biotechnology] [added: Protein Sciences] segment products as of the date of this Annual Report on Form 10-K or as of a comparable date for fiscal [removed: 2017.][added: 2018.]
_Protein [removed: Platforms Segment_][added: Sciences_ _Segment_]
[removed: Our] [added: The] customers for [removed: this segment] [added: the ACD research products] include researchers in academia as well as [removed: by] investigators in [removed: industry, such as] pharmaceutical and biotech companies.
Our biologics line of products [added: in the Analytical Solutions division] is used primarily by production and quality control departments at biotech and pharmaceutical companies.
We sell our [removed: Protein Platforms] products directly to [added: those] customers who are primarily located in North America, [removed: western] Europe and [removed: Japan.][added: China, and through distributors elsewhere.]
Our Simple Western platform is a complete replacement for the traditional manual Western [removed: blot.][added: blotting technique.]
These competitors include Bio-Rad Laboratories, [removed: GE Healthcare,] Merck KGaA, PerkinElmer and Thermo Fisher Scientific.
[removed: Similarly, our SimplePlex platform replaces the traditional manual ELISA assay as well as some flow cytometry-based multiplex immunoassays; competitors] [added: Competitors] include those who supply instruments and reagents for ELISAs, including Meso Scale Discovery, PerkinElmer, Thermo Fisher, Luminex, Millipore, Molecular Devices, Tecan BioTek, [added: Quanterix] and Bio-Rad Laboratories.
[removed: _Protein_ _Platforms] [added: _Protein Sciences] Segment Manufacturing_
We manufacture our [added: Analytical Solutions division instrumentation] products for this [removed: division] [added: segment] at various locations in the United States and Canada.
[removed: We] [added: As with other products sold in this segment, we] are not dependent on any one supplier and are not required to carry significant amounts of inventory to assure ourselves of a continuous allotment of goods from suppliers.
There was no significant backlog of orders for our [removed: Protein Platforms products] [added: Diagnostics and Genomics segment] as of the date of this Annual Report on Form 10-K or as of a comparable date for fiscal [removed: 2017.][added: 2018.]
[removed: _Diagnostics Segment_][added: _Diagnostics and Genomics Segment Products_]
With our deep product portfolio and application expertise, we sell integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression of specific diseases.
Our products aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses.
Our Protein Sciences segment is a leading developer and manufacturer of high-quality purified proteins and reagent solutions, most notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents and T-Cell activation technologies.
This segment also includes protein analysis solutions that offer researchers efficient and streamlined options for automated western blot and multiplexed ELISA workflow.
Our Genomics and Diagnostics segment develops and manufactures diagnostic products, including FDA-regulated controls, calibrators, blood gas and clinical chemistry controls and other reagents for OEM and clinical customers, as well as a portfolio of clinical molecular diagnostic oncology assays, including the ExoDx®_Prostate(IntelliScore)_ test (EPI) for prostate cancer diagnosis.
This segment also manufactures and sells advanced tissue-based in-situ hybridization assays (ISH) for research and clinical use.
Today, our product line extends to over 300,000 products, most of which we manufacture ourselves in multiple locations in North America, England and China.
From fiscal years 2013 through 2019 we have acquired fifteen companies that have expanded the product offerings and geographic footprint of both reporting segments.
_Culture development and talent recruitment and retention._ As we continue to grow both organically and through acquisition, we are intentionally fostering an “epic” culture based on the ideals of empowerment, passion, innovation and collaboration.
The Protein Sciences segment is comprised of divisions with complementary product offerings serving many of the same customers – the Reagent Solutions division and the Analytical Solutions division.
The Reagents Solutions division consists of specialized proteins, such as cytokines and growth factors, antibodies, small molecules, tissue culture sera and cell selection technologies traditionally used by researchers to further their life science experimental activities and by companies developing next generation diagnostics and therapeutics, especially companies developing cell and gene-based therapeutics.
Key product brands include R&D Systems, Tocris Biosciences, Novus Biologicals, Atlanta Biologicals and Quad Technologies.
Most recently, we acquired B-MoGen Technologies, which has a non-viral, transposon-based technology for gene editing, a key technology targeted for the cell and gene therapy market.
The Analytical Solutions division includes manual and automated protein analysis instruments and immunoassays that are used in quantifying proteins in a variety of biological fluids.
Products in this division include traditional manual plate-based immunoassays, fully automated multiplex immunoassays on various instrument platforms, and automated western blotting and isoelectric focusing analysis of complex protein samples.
Key product brands include R&D Systems and ProteinSimple.
Our customers for this segment include researchers in academia & government and industry (chiefly pharmaceutical and biotech companies) as well as Diagnostic/Companion Diagnostic and Therapeutic customers, especially customers engaged in the development of cell & gene based therapies.
Market success is primarily dependent upon product innovation and quality, selection of products, price and reputation.
Our Analytical Solutions division has a number of similar competitors.
Similarly, our SimplePlex platform replaces the traditional manual ELISA assay and introduces an automated multiplex immunoassay feature.
All of our Protein Sciences Segment manufacturing sites are ISO 9001 or ISO 13485 certified or are in the process of being ISO certified.
_Diagnostic__s and Genomics_ _Segment_
The Diagnostics and Genomics segment also includes two divisions focused primarily in the diagnostics market – the Diagnostics division and the Genomics division.
The Diagnostic division consists of regulated products traditionally used as calibrators and controls in the clinical setting.
Also included are instrument and process control products for hematology, blood chemistry, blood gases, coagulation controls and reagents used in various diagnostic applications.
Most of these products are sold on an Original Equipment Manufacturer (OEM) basis to instrument manufacturers with most products being FDA-cleared products.
The Genomics division includes products aimed at nucleic acid (RNA or DNA) analysis that can be used for diagnostic or research applications.
Key product brands include Advanced Cell Diagnostics, or ACD, and Exosome Diagnostics.
ACD products are aimed at RNA analysis of tissue while Exosome Diagnostics focuses on exosome-based liquid biopsy techniques that analyze genes or their transcripts.
The first commercialized test from Exosome Diagnostics is a non-invasive urine-based assay for prostate cancer used as an aid in deciding the need for an initial biopsy.
We offer test services using our non-invasive urine-based assays for prostate cancer detection in the United States through a diagnostic laboratory regulated under the Clinical Laboratory Improvement Amendments, or CLIA.
Customers are patients prescribed such tests by their physicians.
In the Diagnostics division, the competitors for our hematology controls product line include Danaher Beckman Coulter and Streck.
Competitors in the Genomics division are varied, depending on the product line.
While there are not any direct competitors for the RNA-based _in situ_ hybridization products sold under the ACD brand, they are intended to be an alternative to immunohistochemistry assays and PCR-based diagnostic tests in certain circumstances.
The non-invasive urine-based assay offered under our Exosome Diagnostics brand and used for prostate cancer biopsy decisions is supplemental to blood-based prostate-specific antigen (PSA) tests, and is competitive with some other smaller companies that offer liquid biopsy-based alternatives such as 4kscore offered by Opko Health and SelectMDx offered by MDxHealth.
Our Genomics division products and services are all synthesized from widely available products.
| | | __2019__ | | | | __2018__ | | |
| Protein Sciences Segment | | | 40,735 | | | | 40,996 | | | | 41,334 | |
| Diagnostics & Genomics Segment | | | 21,678 | | | | 14,095 | | | | 12,180 | |
With our deep product portfolio and application expertise, we strive to provide the life sciences community with innovative, high-quality scientific tools to better understand biological processes and drive discovery of diagnostic and therapeutic products.
Our Biotechnology Division is a leader in providing high quality consumables and services used for conducting laboratory experiments by both industry and academic scientists within the biotechnology and biomedical life sciences fields, all under the primary brands of R&D Systems, Novus Biologicals, Tocris Bioscience, Atlanta Biologicals, Trevigen, and Advanced Cell Diagnostics.
Our Protein Platforms Division focuses on developing and supplying instrumentation and related consumables designed to simplify protein analysis processes along with single cell protein analysis, all under the ProteinSimple brand.
Through our Diagnostics Division, we serve the clinical markets with regulated products such as controls, calibrators, reagents and immunoassays intended for diagnostic uses.
Today, our product line extends to over 300,000 manufactured products in state of the art facilities to accommodate many of our manufacturing needs.
From 2012 through August 27, 2018 we have acquired 15 companies, eight of which expanded our Biotechnology segment both geographically and through product diversification, three that formed our Protein Platforms segment, and four of which expanded the reach of our Diagnostics segment.
_Operational excellence__._ In recognition of the increased size and scale of the organization, we continue to redesign our development and operational processes to effectively and efficiently support our expanding businesses.
_Biotechnology Segment_
Through our Biotechnology segment, we are one of the world's leading suppliers of specialized proteins, such as cytokines and growth factors, immunoassays, antibodies and related reagents, to the biotechnology research community.
We also sell _in situ_ hybridization, media and other cell culture products and reagents.
_Biotechnology_ _Manufacturing_
Proteins are important for understanding disease because they are the functional units that carry out specific tasks in every cell.
Altered levels of certain proteins can prevent the cell from performing its intended function, produce the energy it requires, maintain its morphology or survive within the tissue.
However, protein analysis is complex given the varied and unique three-dimensional structure of the many proteins of interest.
Our Protein Platforms segment develops, manufactures and sells tools to simplify protein analysis while at the same time achieving more quantitative and reproducible results.
_Protein Platforms Segment Products_
Our Protein Platforms business has an array of platforms useful in various areas of protein analysis.
Developers of biologics-based drugs are required by regulatory agencies, such as FDA, to develop robust processes to ensure that the specific biologic of interest can be identified and characterized accurately and then consistently and reliably produced.
Our Biologics tools help researchers interrogate protein purity and identify contaminants during the development and production of biologics by measuring some elements of protein identity, purity and heterogeneity.
The Western blot, or Western, is one of the most widely-used assays for protein analysis and identification today, and is used by molecular biologists, biochemists and clinicians to determine if a specific protein is present in a sample.
Our Simple Western platform is a fully-automated Western blot analytical technique that can identify and quantify a protein of interest in a more sensitive, automated and less time-intensive manner.
A common assay used in research and clinical diagnostics is the ELISA, or enzyme-linked immunosorbent assay.
The SimplePlex platform is a transformative immunoassay technology which integrates an innovatively designed microfluidic cartridge with a state-of-the-art analyzer to deliver a bench-top immunoassay system that is more sensitive than a manual multi-well place based ELISA with none of the traditional challenges of assay design or repeatability.
The Single Cell Western platform and related reagents perform western blot assays on individual cells versus an entire cell population.
With this tool, customers can elucidate the properties of individual cells to better understand cell behavior that can shape the overall cell population response in a disease or normal state.
_Protein Platforms Segment Cus__tomers and Distribution Methods_
We also sell through third party distributors in China, southern Europe and the rest of the world.
Our sales are widely distributed, and no single end-user customer accounted for more than 10% of Protein Platforms' net sales during fiscal 2018, 2017 or 2016.
_Protein Platforms Segment Competitors_
_Diagnostics Segment Products_
This segment includes blood chemistry and blood gas quality controls, hematology instrument controls, diagnostic immunoassays, and other bulk and custom reagents for the _in vitro_ diagnostic market worldwide.
In fiscal 2018, 2017 and 2016, OEM agreements accounted for $62.8 million, $60.7 million, and $54.2 million, or 57%, 57%, and 52% of division net sales in each fiscal year, respectively.
One OEM customer accounted for approximately 12% of the Diagnostics Division's net sales during fiscal year 2017.
This customer did not amount to 10% or more of the Company's consolidated net sales during fiscal year 2017.
There was no significant backlog of orders for our Diagnostics products as of the date of this Annual Report on Form 10-K or as of a comparable date for fiscal 2017.
| | | __2018__ | | | | __2017__ | | | | __2016__ | | |
| Biotechnology | | $ | 35,895 | | | $ | 35,507 | | | $ | 26,981 | |
| Protein Platforms | | | 15,348 | | | | 14,424 | | | | 14,610 | |
| Diagnostics | | | 3,848 | | | | 3,583 | | | | 3,596 | |
| Corporate | | | 238 | | | | \- | | | | \- | |
An excerpt. Shown here: 40 of 91 rewritten, 40 of 47 added and 40 of 45 removed. The counts are complete. For every sentence, read Item 1. BUSINESS in the FY2019 filing and the FY2018 filing.
Item 3. LEGAL PROCEEDINGS
1 rewritten, 0 added, 0 removed, 0 unchanged
As of August [removed: 27, 2018,] [added: 28, 2019,] the Company is not a party to any legal proceedings that, individually or in the aggregate, are reasonably expected to have a material adverse effect on the Company's business, results of operations, financial condition or cash flows.
Cover and table of contents
34 rewritten, 2 added, 1 removed, 70 unchanged
10-K 1 [removed: tech20180630_10k.htm] [added: tech20190630_10k.htm] FORM 10-K
For the fiscal year ended June 30, [removed: 2018,] [added: 2019,] or
| Title of each class | [added: Trading Symbol(s)] | Name of each exchange on which registered |
| Common Stock, $0.01 par value | [added: TECH] | The NASDAQ Stock Market LLC |
[removed: Securities registered pursuant to Section 12(g) of the Act: None][added: Securities registered pursuant to Section 12(g) of the Act: None]
Indicate by check mark whether the registrant has submitted electronically [removed: and posted on its corporate website, if any,] every Interactive Data File required to be submitted [removed: and posted] pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit [removed: and post] such files).
As of December 31, [removed: 2017] [added: 2018] the aggregate market value of the Common Stock held by non-affiliates of the Registrant was [removed: $3.4] [added: $5.5] billion based upon the closing sale price as reported on The Nasdaq Stock Market [removed: ($129.55] [added: ($144.72] per share).
As of August [removed: 23, 2018, 37,731,348] [added: 26, 2019, 38,063,504] shares of the Company’s Common Stock ($0.01 par value) were outstanding.
Portions of the Company’s Proxy Statement for its [removed: 2018] [added: 2019] Annual Meeting of Shareholders are incorporated by reference into Part III.
| [PART [removed: I](#p1)] [added: I](#part1)] | | |
| Item 1. | [removed: [Business](#i1)] [added: [Business](#item1)] | 1 |
| Item 1A. | [Risk [removed: Factors](#i1a)] [added: Factors](#item1a)] | 10 |
| Item 1B. | [Unresolved Staff [removed: Comments](#i1b)] [added: Comments](#item1b)] | [removed: 18] [added: 19] |
| Item 2. | [removed: [Properties](#i2)] [added: [Properties](#item2)] | [removed: 18] [added: 19] |
| Item 3. | [Legal [removed: Proceedings](#i3)] [added: Proceedings](#item3)] | [removed: 18] [added: 19] |
| Item 4. | [Mine Safety [removed: Disclosures](#i4)] [added: Disclosures](#item4)] | [removed: 18] [added: 19] |
| [PART [removed: II](#p2)] [added: II](#part2)] | | |
| Item 5. | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i5)] [added: Securities](#item5)] | [removed: 19] [added: 20] |
| Item 6. | [Selected Financial [removed: Data](#i6)] [added: Data](#item6)] | [removed: 21] [added: 22] |
| Item 7. | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i7)] [added: Operations](#item7)] | [removed: 22] [added: 23] |
| Item 7A. | [Quantitative and Qualitative Disclosures about Market [removed: Risk](#i7a)] [added: Risk](#item7a)] | [removed: 34] [added: 35] |
| Item 8. | [Financial Statements and Supplementary [removed: Data](#i8)] [added: Data](#item8)] | [removed: 35] [added: 36] |
| Item 9. | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i9)] [added: Disclosure](#item9)] | [removed: 67] [added: 72] |
| Item 9A. | [Controls and [removed: Procedures](#i9a)] [added: Procedures](#item9a)] | [removed: 67] [added: 73] |
| Item 9B. | [Other [removed: Information](#i9b)] [added: Information](#item9b)] | [removed: 68] [added: 74] |
| [PART [removed: III](#p3)] [added: III](#part3)] | | |
| Item 10. | [Directors, Executive [removed: Officers](#i10)] [added: Officers](#item10)] | [removed: 69] [added: 75] |
| Item 11. | [Executive [removed: Compensation](#i11)] [added: Compensation](#item11)] | [removed: 69] [added: 75] |
| Item 12. | [Security Ownership of Certain Beneficial Owners and Management and Related Shareholder [removed: Matters](#i12)] [added: Matters](#item12)] | [removed: 69] [added: 75] |
| Item 13. | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i13)] [added: Independence](#item13)] | [removed: 69] [added: 75] |
| Item 14. | [Principal Accounting Fees and [removed: Services](#i14)] [added: Services](#item14)] | [removed: 69] [added: 75] |
| [PART [removed: IV](#p4)] [added: IV](#part4)] | | |
| Item 15. | [Exhibits, Financial Statement [removed: Schedules](#i15)] [added: Schedules](#item15)] | [removed: 70] [added: 76] |
| | [removed: [SIGNATURES](#sigs)] [added: [SIGNATURES](#signatures)] | [removed: 71] [added: 78] |
DOCUMENTS INCORPORATED BY REFERENCE
i.
DOCUMENTS INCORPORATED BY REFERENCE
Item 2. PROPERTIES
5 rewritten, 1 added, 0 removed, 23 unchanged
The Minneapolis facilities are utilized by both the Company's [removed: Biotechnology] [added: Protein Sciences] and Diagnostics [added: and Genomics] segments.
The Company is currently leasing [removed: or plans to lease] the remaining space in the complex as retail and office space.
This facility is utilized by the Company's [removed: Biotechnology and] Protein [removed: Platforms] [added: Sciences and Diagnostics and Genomics] segments.
This facility is utilized by the Company’s [removed: Biotechnology segment.][added: Protein Sciences.]
The Company leases the following material facilities, all of which are primarily utilized by the Company's [removed: Biotechnology] [added: Protein Sciences] segment with the exception of the locations used by the Company's ProteinSimple and CyVek subsidiaries, which support [added: both] the Protein [removed: Platforms] [added: Sciences] segment and the [removed: Bionostics, Cliniqa and Exosome] Diagnostics [removed: subsidiaries (Diagnostics] [added: & Genomics] segment).
| Exosome Diagnostics | | Waltham, Massachusetts | | Office/manufacturing/warehouse | | 28,000 | |
Item 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED SHAREHOLDER
5 rewritten, 10 added, 16 removed, 8 unchanged
As of August [removed: 17, 2018,] [added: 26, 2019,] there were over [removed: 40,000] [added: 43,000] beneficial shareholders of the Company's common stock and over [removed: 425] [added: 150] shareholders of record.
The Company paid [removed: quarterly] [added: annual] cash dividends totaling [added: $48.4 million,] $48.0 million, [removed: $47.7 million] and [removed: $47.6] [added: $47.7] million in fiscal [removed: 2018, 2017] [added: 2019, 2018] and [removed: 2016,] [added: 2017,] respectively.
As of June 30, 2018, the maximum approximate dollar value of shares that [removed: may yet be] [added: could have been] purchased under the Company's [added: then] existing stock repurchase plan [removed: is] [added: was] approximately $125 [removed: million.][added: million, with no specified end period.]
The following chart compares the cumulative total shareholder return on the Company's common stock with the S&P Midcap 400 [removed: Index, the S&P 400 Biotechnology Index,] [added: Index] and the S&P 400 MidCap Life Sciences Tools and Services [removed: Index.][added: Index.The comparison assumes $100 was invested on the last trading day before July 1, 2014 in the Company's common stock and in each of the foregoing indices and assumes reinvestment of dividends.]
[removed: ][added: | |  | |]
The Company repurchased 95,000 shares during fiscal 2019 for $15.4 million at an average share price of $162.15.
The Company did not repurchase any shares in fiscal 2018 or 2017.
During fiscal 2019, the Board rescinded the existing stock repurchase plan and implemented a new repurchase plan, which grants management the discretion to mitigate the dilutive effect of stock option exercises by authorizing repurchase of shares up to the amount of stock returned to the corporation through stock option exercises of $19.2 million, the dilutive effect of stock option exercises in fiscal 2018, which is then adjusted for the dilutive effect of additional stock option exercises occurring subsequent to June 30, 2018.
As of June 30, 2019, we have authorization of approximately $42 million that may yet be used to purchase additional shares under the newly implemented stock repurchase program.
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among Bio-Techne Corporation, the S&P Midcap 400 Index,
and S&P 400 Mid-Cap Life Sciences Tools and Services Index
| --- | --- | --- |
| | | |
| | *$100 invested on 6/30/14 in stock or index, including reinvestment of dividends. Fiscal year ending June 30. Copyright© 2019 Standard & Poor's, a division of S&P Global. All rights reserved. | |
_Market Price of Common Stock_
The Company's common stock trades on the NASDAQ Global Select Market under the symbol "TECH." The following table sets forth for the periods indicated the high and low sales price per share for the Company's common stock as reported by the NASDAQ Global Select Market.
| | | __Fiscal 201__8_ _Price__ | | | | | | | | __Fiscal 201__7_ _Price__ | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | __High__ | | | | __Low__ | | | | __High__ | | | | __Low__ | | |
| | | | | | | | | | | | | | | | | |
| First Quarter | | $ | 124.00 | | | $ | 112.33 | | | $ | 117.42 | | | $ | 103.99 | |
| Second Quarter | | | 136.39 | | | | 120.61 | | | | 112.20 | | | | 98.92 | |
| Third Quarter | | | 151.89 | | | | 128.06 | | | | 108.58 | | | | 95.68 | |
| Fourth Quarter | | | 166.81 | | | | 142.66 | | | | 119.98 | | | | 98.22 | |
The Company entered into a revolving line of credit in July 2016, which would prohibit payment of dividends to Company shareholders in the event of a default thereunder.
The Credit Agreement that governs the revolving line of credit contains customary events of default.
There was no share repurchase activity by the Company in fiscal 2018.
The plan does not have an expiration date.
We have included in the chart the S&P 400 MidCap Life Sciences Tools and Services Index, which we expect will replace the S&P 400 Biotechnology Index in our chart in future years as this index now only includes one company.
The comparison assumes $100 was invested on the last trading day before July 1, 2013 in the Company's common stock and in each of the foregoing indices and assumes reinvestment of dividends.
Item 6. SELECTED FINANCIAL DATA
23 rewritten, 0 added, 2 removed, 14 unchanged
| _Income and Share Data:_ | | [removed: __2018__(1)__] [added: _2019(1)_] | | | | [removed: __2017__(2)__] [added: _2018(2)_] | | | | [removed: __2016__(3)__] [added: _2017(3)_] | | | | [removed: __2015__(4)__] [added: _2016(4)_] | | | | [removed: __2014__(5)__] [added: _2015(5)_] | | |
| Net sales | | $ | [removed: 642,993] [added: 714,006] | | | $ | [removed: 563,003] [added: 642,993] | | | $ | [removed: 499,023] [added: 563,003] | | | $ | [removed: 452,246] [added: 499,023] | | | $ | [removed: 357,763] [added: 452,246] | |
| Operating income | | | [removed: 136,178] [added: 146,719] | | | | [removed: 120,584] [added: 136,178] | | | | [removed: 150,593] [added: 120,584] | | | | [removed: 147,023] [added: 150,593] | | | | [removed: 159,750] [added: 147,023] | |
| Earnings before income taxes (6) | | | [removed: 125,952] [added: 112,015] | | | | [removed: 111,961] [added: 125,952] | | | | [removed: 147,481] [added: 111,961] | | | | [removed: 154,162] [added: 147,481] | | | | [removed: 161,392] [added: 154,162] | |
| Net earnings | | | [removed: 126,150] [added: 96,072] | | | | [removed: 76,086] [added: 126,150] | | | | [removed: 104,476] [added: 76,086] | | | | [removed: 107,735] [added: 104,476] | | | | [removed: 110,948] [added: 107,735] | |
| Diluted earnings per share | | | [removed: 3.31] [added: 2.47] | | | | [removed: 2.03] [added: 3.31] | | | | [removed: 2.80] [added: 2.03] | | | | [removed: 2.89] [added: 2.80] | | | | [removed: 3.00] [added: 2.89] | |
| Average common and common equivalent shares - diluted (in thousands) | | | [removed: 38,055] [added: 38,892] | | | | [removed: 37,500] [added: 38,055] | | | | [removed: 37,326] [added: 37,500] | | | | [removed: 37,231] [added: 37,326] | | | | [removed: 37,005] [added: 37,231] | |
| _Balance Sheet Data as of June 30:_ | | [removed: __2018__] [added: __2019__] | | | | [removed: __2017__] [added: __2018__] | | | | [removed: __2016__] [added: __2017__] | | | | [removed: __2015__] [added: __2016__] | | | | [removed: __2014__] [added: __2015__] | | |
| Cash, cash equivalents and short-term available-for-sale investments | | [added: $] | [removed: 181,754] [added: 166,033] | | | $ | [removed: 157,714] [added: 181,754] | | | $ | [removed: 95,835] [added: 157,714] | | | $ | [removed: 110,921] [added: 95,835] | | | $ | [removed: 363,354] [added: 110,921] | |
| Working capital | | | [removed: 318,856] [added: 310,622] | | | | [removed: 212,503] [added: 318,856] | | | | [removed: 199,744] [added: 212,503] | | | | [removed: 208,515] [added: 199,744] | | | | [removed: 443,022] [added: 208,515] | |
| Total assets | | | [removed: 1,593,202] [added: 1,884,410] | | | | [removed: 1,558,219] [added: 1,593,202] | | | | [removed: 1,129,581] [added: 1,558,219] | | | | [removed: 1,063,360] [added: 1,129,581] | | | | [removed: 862,491] [added: 1,063,360] | |
| Total shareholders' equity | | | [removed: 1,079,061] [added: 1,165,589] | | | | [removed: 949,627] [added: 1,079,061] | | | | [removed: 879,280] [added: 949,627] | | | | [removed: 846,935] [added: 879,280] | | | | [removed: 795,265] [added: 846,935] | |
| _Cash Flow Data:_ | | [removed: __2018__] [added: __2019__] | | | | [removed: __2017__] [added: __2018__] | | | | [removed: __2016__] [added: __2017__] | | | | [removed: __2015__] [added: __2016__] | | | | [removed: __2014__] [added: __2015__] | | |
| Net cash provided by operating activities | | [removed: $] | [removed: 170,367] [added: 181,619] | | | $ | [removed: 143,721] [added: 170,367] | | | $ | [removed: 144,157] [added: 143,721] | | | $ | [removed: 139,359] [added: 144,157] | | | $ | [removed: 136,762] [added: 139,359] | |
| Capital expenditures | | | [removed: 20,934] [added: 25,411] | | | | [removed: 15,179] [added: 20,934] | | | | [removed: 16,898] [added: 15,179] | | | | [removed: 19,905] [added: 16,898] | | | | [removed: 13,821] [added: 19,905] | |
| Cash dividends declared per share | | | 1.28 | | | | 1.28 | | | | 1.28 | | | | [removed: 1.27] [added: 1.28] | | | | [removed: 1.23] [added: 1.27] | |
| _Employee Data as of June 30:_ | | [removed: __2018__] [added: __2019__] | | | | [removed: __2017__] [added: __2018__] | | | | [removed: __2016__] [added: __2017__] | | | | [removed: __2015__] [added: __2016__] | | | | [removed: __2014__] [added: __2015__] | | |
| Employees | | | [removed: 1,943] [added: 2,255] | | | | [removed: 1,789] [added: 1,943] | | | | [removed: 1,560] [added: 1,789] | | | | [removed: 1,356] [added: 1,560] | | | | [removed: 967] [added: 1,356] | |
| (1) [added: (2)] | The Company acquired [added: Quad Technologies on July 2, 2018, Exosome Diagnostics on August 1, 2018 and B-Mogen on June 4, 2019. The Company acquired] Trevigen on September 5, 2017, Atlanta Biologicals on January 2, 2018, and Eurocell Diagnostics on February 1, 2018. |
| [removed: (2)] [added: (3)] | The Company acquired Space on July 1, 2016, and Advanced Cell Diagnostics on August 1, 2016. |
| [removed: (3)] [added: (4)] | The Company acquired Cliniqa on July 8, 2015, and Zephyrus on March 21, 2016. |
| [removed: (4)] [added: (5)] | The Company acquired Novus Biologicals on July 2, 2014, ProteinSimple on July 31, 2014, and CyVek on November 3, 2014. |
| (6) | Earnings before income taxes included acquisition related expenses related to amortization of intangibles, costs recognized on sale of acquired inventories and professional fees associated with acquisition activity, as follows: [added: 2019 - $64.9 million;] 2018 - $74.2 million; 2017 - $73.2 million; 2016 - $37.6 million; 2015 - $37.6 [removed: million; 2014 - $20.0] million. |
| --- | --- |
| (5) | The Company acquired Bionostics on July 22, 2013, and PrimeGene on April 30, 2014. |
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
561 rewritten, 387 added, 210 removed, 316 unchanged
| | | [removed: __201__8__ | | | | __2017__] [added: _2017_] | | | | [removed: __2016__] [added: _2016_] | | |
| Net sales | | $ | [removed: _642,993_] [added: 714,006] | | | $ | [removed: _563,003_] [added: 642,993] | | | $ | [removed: _499,023_] [added: 563,003] | |
| Cost of sales | | | [removed: _210,850_] [added: 240,515] | | | | [removed: _188,462_] [added: 210,850] | | | | [removed: _162,364_] [added: 188,462] | |
| Gross margin | | | [removed: _432,143_] [added: 473,491] | | | | [removed: _374,541_] [added: 432,143] | | | | [removed: _336,659_] [added: 374,541] | |
| Selling, general and administrative | | | [removed: _240,636_] [added: 264,359] | | | | [removed: _200,443_] [added: 240,636] | | | | [removed: _140,879_] [added: 200,443] | |
| Research and development | | | [removed: _55,329_] [added: 62,413] | | | | [removed: _53,514_] [added: 55,329] | | | | [removed: _45,187_] [added: 53,514] | |
| Total operating expenses | | | [removed: _295,965_] [added: 326,772] | | | | [removed: _253,957_] [added: 295,965] | | | | [removed: _186,066_] [added: 253,957] | |
| Operating income | | | [removed: _136,178_] [added: 146,719] | | | | [removed: _120,584_] [added: 136,178] | | | | [removed: _150,593_] [added: 120,584] | |
| Interest expense | | | [removed: _(10,188_] [added: (21,705] | ) | | | [removed: _(7,361_] [added: (10,188] | ) | | | [removed: _(1,748_] [added: (7,361] | ) |
| Interest income | | | [removed: _409_] [added: 569] | | | | [removed: _304_] [added: 409] | | | | [removed: _249_] [added: 304] | |
| Other non-operating income (expense), net | | | [removed: _(447_] [added: (13,568] | ) | | | [removed: _(1,566_] [added: (447] | ) | | | [removed: _(1,613_] [added: (1,566] | ) |
| Total other income [removed: (expense)] [added: (expense), net] | | | [removed: _(10,226_] [added: (34,704] | ) | | | [removed: _(8,623_] [added: (10,226] | ) | | | [removed: _(3,112_] [added: (8,623] | ) |
| Earnings before income taxes | | | [removed: _125,952_] [added: 112,015] | | | | [removed: _111,961_] [added: 125,952] | | | | [removed: _147,481_] [added: 111,961] | |
| Income taxes [added: (benefit)] | | | [removed: _(198_] [added: 15,943] | [removed: )] | | | [removed: _35,875_] [added: (198)] | | | | [removed: _43,005_] [added: 35,875] | |
| Net earnings | | | [removed: _126,150_] [added: 96,072] | | | | [removed: _76,086_] [added: 126,150] | | | | [removed: _104,476_] [added: 76,086] | |
| Foreign currency translation adjustments | | | [removed: _(1,572_] [added: (4,487] | ) | | | [removed: _(3,061_] [added: (1,572] | ) | | | [removed: _(19,888_] [added: (3,061] | ) |
| Unrealized gains (losses) on available-for-sale investments, net of tax of [removed: $398, $(6,501),] [added: $398 in FY18] and [removed: $3,794, respectively] [added: $(6,501) in FY17] | | | [removed: _5,693_] [added: \-] | | | | [removed: _24,531_] [added: 5,693] | | | | [removed: _(19,924_] [added: 24,531] | [removed: )] |
| Other comprehensive income (loss) | | | [removed: _4,121_] [added: (14,024] | [added: )] | | | [removed: _21,470_] [added: 4,121] | | | | [removed: _(39,812_] [added: 21,470] | [removed: )] |
| Comprehensive income | | $ | [removed: _130,271_] [added: 82,048] | | | [removed: $] | [removed: _97,556_] [added: 130,271] | | | $ | [removed: _64,664_] [added: 97,556] | |
| Basic | | $ | [removed: _3.36_] [added: 2.54] | | | $ | [removed: _2.04_] [added: 3.36] | | | $ | [removed: _2.81_] [added: 2.04] | |
| Diluted | | $ | [removed: _3.31_] [added: 2.47] | | | $ | [removed: _2.03_] [added: 3.31] | | | $ | [removed: _2.80_] [added: 2.03] | |
| Basic | | | [removed: _37,476_] [added: 37,781] | | | | [removed: _37,313_] [added: 37,476] | | | | [removed: _37,194_] [added: 37,313] | |
| Diluted | | | [removed: _38,055_] [added: 38,892] | | | | [removed: _37,500_] [added: 38,055] | | | | [removed: _37,326_] [added: 37,500] | |
| | | [removed: __June 30,__] [added: _June 30,_] | | | | | | |
| | | [removed: __2018__] [added: ___2019___] | | | | [removed: __2017__] [added: ___2018___] | | | [added: | _2017_ | | |]
| Cash and cash equivalents [added: at beginning of year] | | [removed: $] | [removed: _121,990_] [added: 121,990] | | | [removed: $] | [removed: _91,612_] [added: 91,612] | | [added: | | 64,237 | |]
| Short-term available-for-sale investments | | | [removed: _59,764_] [added: 65,147] | | | | [removed: _66,102_] [added: 59,764] | |
| Accounts receivable, less allowance for doubtful accounts of [removed: $839] [added: $980] and [removed: $696,] [added: $839,] respectively | | | [removed: _120,296_] [added: 137,466] | | | | [removed: _116,830_] [added: 120,296] | |
| Inventories | | | [removed: _85,648_] [added: 91,050] | | | | [removed: _60,151_] [added: 85,648] | |
| Other current assets | | | [removed: _10,668_] [added: 18,058] | | | | [removed: _13,330_] [added: 10,668] | |
| Total current assets | | | [removed: _398,366_] [added: 412,607] | | | | [removed: _348,025_] [added: 398,366] | |
| Property and equipment, net | | | [removed: _145,348_] [added: 154,039] | | | | [removed: _135,124_] [added: 145,348] | |
| Goodwill | | | [removed: _597,890_] [added: 732,667] | | | | [removed: _579,026_] [added: 597,890] | |
| Intangible assets, net | | | [removed: _446,332_] [added: 579,429] | | | | [removed: _452,042_] [added: 446,332] | |
| Other assets | | | [removed: _5,266_] [added: 5,668] | | | | [removed: _44,002_] [added: 5,266] | |
| Total assets | | $ | [removed: _1,593,202_] [added: 1,884,410] | | | $ | [removed: _1,558,219_] [added: 1,593,202] | |
| Trade accounts payable | | $ | [removed: _18,452_] [added: 16,210] | | | $ | [removed: _16,856_] [added: 18,452] | |
| Salaries, wages and related accruals | | | [removed: _23,710_] [added: 28,638] | | | | [removed: _26,602_] [added: 23,710] | |
| Income taxes payable | | | [removed: _8,878_] [added: 5,764] | | | | [removed: _2,478_] [added: 8,878] | |
| Contingent consideration payable | | | [removed: _\-_] [added: 3,400] | | | | [removed: _65,100_] [added: \-] | |
| Unrealized gains (losses) on derivative instruments - cash flow hedges, net of tax of $2,921 in FY19 | | | (9,537 | ) | | | \- | | | | \- | |
| Cash and cash equivalents | | $ | 100,886 | | | $ | 121,990 | |
| Accrued expenses | | | 26,389 | | | | 20,361 | |
| Contract liabilities | | | 9,084 | | | | 8,109 | |
| Current portion of long-term debt obligations | | | 12,500 | | | | \- | |
| Cumulative effect adjustments due to adoption of new accounting standards and other | | | | | | | | | | | | | | | 25,276 | | | | (24,682 | ) | | | 594 | |
| Share repurchases | | | (95 | ) | | | (1 | ) | | | | | | | (15,404 | ) | | | | | | | (15,405 | ) |
| Cash dividends | | | | | | | | | | | | | | | (48,366 | ) | | | | | | | (48,364 | ) |
| Balances at June 30, 2019 | | | 37,934 | | | $ | 379 | | | $ | 316,797 | | | $ | 931,934 | | | $ | (83,521 | ) | | $ | 1,165,589 | |
| Fair value adjustment on available for sale investments | | | 16,067 | | | | \- | | | | \- | |
| Re-purchases of common stock | | | (15,405 | ) | | | \- | | | | \- | |
With our deep product portfolio and application expertise, we sell integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression of specific diseases.
Our products aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses.
_Revenue recognition:_ The Company adopted _ASC 606_ \- _Revenue from Contracts with Customers_ on July 1, 2018 using the modified retrospective transition approach.
The core principle of ASC 606 is that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.
Refer to the _Recently Adopted Accounting Pronouncements_ section of Note 1 for additional information regarding our adoption of ASC 606 and and Note 2 for additional information regarding our revenue recognition policy under _ASC 606_.
Unrealized gains and losses on available-for-sale securities are included within other income (expense) in fiscal 2019 as the Company adopted ASU 2018-02 on July 1, 2018, as further described in the _Recently Adopted Accounting Pronouncements_ section of Note 1.
Unrealized gains or losses on available-for-sale securities were recorded within comprehensive income in fiscal years 2018 and 2017.
For certain proteins, antibodies, and chemically based manufactured products, the Company produces larger batches of established products than current sales requirements due to economies of scale through a highly controlled manufacturing process.
The Company forecasts usage for its products based on several factors including historical demand, current market dynamics, and technological advances.
The Company forecasts product usage on an individual product level for a period that is consistent with our ability to reasonably forecast inventory usage for that product.
There have been no material changes to the Company’s estimates of the net realizable value for excess and obsolete inventory or other types of inventory reserve and inventory cost adjustments in the fiscal years presented.
Additionally, current and historical reserves recorded to reduce the cost of inventory to its net realizable value become part of the new cost basis for the inventory item in accordance with _ASC 330 - Inventory_.
_Contingent Consideration:_ Contingent Consideration relates to the potential payment for an acquisition that is contingent upon the achievement of the acquired business meeting certain product development milestones and/or certain financial performance milestones.
The Company records contingent consideration at fair value at the date of acquisition based on the consideration expected to be transferred.
For potential payments related to financial performance milestones, we use a real option model in calculating the fair value of the contingent consideration liabilities.
The assumptions utilized in the calculation based on financial performance milestones include projected revenue and/or EBITDA amounts, volatility and discount rates.
For potential payments related to product development milestones, we estimated the fair value based on the probability of achievement of such milestones.
The assumptions utilized in the calculation of the acquisition date fair value include probability of success and the discount rates.
Contingent consideration involves certain assumptions requiring significant judgment and actual results may differ from assumed and estimated amounts.
Contingent consideration is remeasured each reporting period, and subsequent changes in fair value, including accretion for the passage of time, are recognized within selling, general and administrative in the consolidated statement of earnings and comprehensive income
2019 _Goodwill Impairment Analyses_
At the beginning of the quarter ended March 31, 2019, the Company realigned the management of certain business processes between reporting units within the same reportable segment.
A goodwill allocation was performed between the impacted reporting units based on the relative fair value of the processes realigned.
In conjunction with the realignment, a quantitative goodwill impairment assessment was performed both prior to and subsequent to the realignment.
The quantitative assessment indicated that all of the impacted reporting units had substantial headroom both prior to and subsequent to the realignment.
The quantitative assessments completed as of January 1, 2019 indicated that all tested reporting units had a substantial amount of headroom.
The Company has elected April 1 as our annual goodwill impairment date for the Exosome reporting unit.
The Company has historically completed our goodwill impairment assessment of our legacy reporting units as of June 30.
To better align with our annual internal planning and operating cycle and the underlying changes in our organizational model and business, we changed our annual goodwill impairment assessment for all legacy reporting units to be as of April 1.
| | | | | | | | | | | | | |
| Cash dividends per common share: | | $ | _1.28_ | | | $ | _1.28_ | | | $ | _1.28_ | |
| | | | | | | | | |
| Accrued expenses | | | _21,403_ | | | | _18,518_ | |
| Deferred revenue, current | | | _7,067_ | | | | _5,968_ | |
| Balances at June 30, 2015 | | | _37,153_ | | | $ | _371_ | | | $ | _163,306_ | | | $ | _713,851_ | | | $ | _(30,593_ | ) | | $ | _846,935_ | |
| Surrender and retirement of stock to exercise options | | | _(3_ | ) | | | _\-_ | | | | _(275_ | ) | | | | | | | | | | | _(275_ | ) |
| Cash dividends | | | _(47,973_ | ) | | | _(47,325_ | ) | | | _(47,607_ | ) |
| Excess tax benefit from stock option exercises | | | _\-_ | | | | _514_ | | | | _566_ | |
| Cash and cash equivalents at beginning of year | | | _91,612_ | | | | _64,237_ | | | | _54,532_ | |
With its deep product portfolio and application expertise, Bio-Techne is a leader in providing specialized proteins, including cytokines and growth factors, and related immunoassays, small molecules and other reagents to the research and diagnostics markets.
_Revenue recognition:_ The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured.
Freight charges billed to end-users are included in net sales and freight costs are included in cost of sales.
Freight charges on shipments to distributors are paid directly by the distributor.
Sales, use, value-added and other excise taxes are _not_ included in revenue.
The primary method used to estimate standalone selling price is the list price of each distinct product or service as this represents the best estimate of selling price.
Unrealized gains and losses on available-for-sale securities are excluded from income, but are included, net of taxes, in other comprehensive income.
If an "other-than-temporary" impairment is determined to exist, the difference between the value of the investment security recorded in the financial statements and the Company's current estimate of the fair value is recognized as a charge to earnings in the period in which the impairment is determined.
To meet strict customer quality standards, the Company has established a highly controlled manufacturing process for proteins, antibodies and its chemically-based products.
These products require the initial manufacture of multiple batches to determine if quality standards can be consistently met.
In addition, the Company will produce larger batches of established products than current sales requirements due to economies of scale.
The Company values its manufactured protein and antibody inventory based on a _two_\-year forecast and its chemically-based products on a _five_\-year forecast.
Inventory quantities in excess of the forecast are _not_ valued due to uncertainty over salability.
The company records a lower of cost or net realizable value adjustment to cost of sales for those quantities that are in excess of the manufactured protein and antibody _two_\-year forecast and the chemically-based products _five_ year forecast.
For the years ended _June 30, 2018,_ _2017,_ and _2016_ the amount recognized in net sales of inventory sold that was _not_ valued is _not_ material.
__2016_ Goodwill Impairment Analysis_
The Company used a qualitative test for all reporting units during the _fourth_ quarter for fiscal year _2016_.
The company elected to utilize a quantitative test for the Protein Platforms reporting unit for fiscal year _2016_ using the previously described income approach given that this is a newer reporting unit created primarily through acquisitions.
The qualitative analyses for our other reporting units completed during _2016_ evaluated factors including, but _not_ limited to, economic, market and industry conditions, cost factors and the overall financial performance of the reporting units.
Based on the testing performed for the Protein Platforms reporting unit, fair value exceeded carrying value by a substantial amount and _no_ adjustment to the carrying value of goodwill was necessary.
In _July 2015,_ the FASB issued ASU _2015_\-_11,_ _Simplifying the Measurement of Inventory_.
This provision would require inventory that was previously recorded using _first_\-in, _first_\-out (“FIFO”) to be recorded at lower of cost or net realizable value.
Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.
In _March 2016,_ the FASB issued ASU _2016_\-_09,_ _Improvements to Employee Share-Based Payment Accounting_.
This standard includes provisions intended to simplify various aspects related to how share-based payments are accounted for and presented in the financial statements.
We adopted this standard on _July 1, 2017._ The Company expects its reported provision for income taxes to become more volatile, dependent upon market prices and volume of share-based compensation exercises and vesting of options.
The standard added to the FASB Codification the guidance provided by the SEC in _December 2017_ regarding the accounting for the Tax Cuts and Jobs Act ("Tax Act").
We complied with SAB _No._ _118_ when preparing our annual consolidated financial statements for the year ended _June 30, 2018._ Reasonable estimates were used in determining several of the components of the impact of the Tax Act, including our fiscal _2018_ deferred income tax activity and the amount of post-_1986_ foreign deferred earnings subject to the repatriation transition tax.
We are still analyzing certain aspects of the Tax Act and refining our calculations, which could potentially affect the measurement of our deferred tax balances and the amount of the repatriation toll charge liability, and ultimately cause us to revise our initial estimates in future periods.
In addition, changes in interpretations, assumptions and guidance regarding the Tax Act, as well as the potential for technical corrections, could have a material impact on our effective tax rate in future periods.
An excerpt. Shown here: 40 of 561 rewritten, 40 of 387 added and 40 of 210 removed. The counts are complete. For every sentence, read Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA in the FY2019 filing and the FY2018 filing.
Item 9A. CONTROLS AND PROCEDURES
7 rewritten, 4 added, 11 removed, 23 unchanged
Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, [removed: 2018,] [added: 2019,] our disclosure controls and procedures were effective.
We acquired Trevigen Inc (Trevigen) on September 5, 2017, Atlanta Biologicals (Atlanta) on January 2, 2018, and Eurocell Diagnostics SAS (Eurocell) on February 1, [removed: 2018.][added: 2018, and we have implemented our internal control structure over these and incorporated its operations into our assessment of internal control over financial reporting as of June 30, 2019.]
[removed: Trevigen, Atlanta,] [added: Quad, Exosome,] and [removed: Eurocell] [added: B-Mogen] represented approximately [removed: 5.3%] [added: 17.2%] of our total assets and [removed: 1.7%] [added: 0.5%] of our total revenues as of and for the year ended June 30, [removed: 2018.][added: 2019.]
We excluded internal control over financial reporting associated with [removed: Trevigen, Atlanta,] [added: Quad, Exosome,] and [removed: Eurocell] [added: B-Mogen] from our assessment of the effectiveness of our internal control over financial reporting as of June 30, [removed: 2018.][added: 2019.]
Based on our assessment and those criteria, our Chief Executive Officer and Chief Financial Officer concluded that our internal control over financial reporting was effective as of June 30, [removed: 2018][added: 2019.]
| (c) | [removed: Remediation of Material Weaknesses] [added: Changes] in Internal Control Over Financial Reporting |
[removed: Other than the acquisitions discussed above and the actions described under "Remediation of Material Weakness in Internal Control Over Financial Reporting," there] [added: There] were no other changes in the Company's internal control over financial reporting during [removed: the fourth quarter of] fiscal year [removed: 2018] [added: 2019] that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.
We acquired QT Holding Corporation (Quad) on July 2, 2018, Exosome Diagnostics Inc. (Exosome) on August 1, 2018, and BMG Merger Sub, Inc (B-Mogen) on June 4, 2019 .
As previously announced, we acquired Quad on July 2, 2018, Exosome on August 1, 2018, and B-Mogen on June 4, 2019.
We have not fully evaluated any changes in internal control over financial reporting associated with these acquisitions and therefore any material changes that may result from these acquisitions have not been disclosed in this report.
We intend to disclose all material changes resulting from these acquisitions within or prior to the time of our first annual assessment of internal control over financial reporting that is required to include these entities.
| --- | --- |
As previously disclosed in Item 9A of Part II of our Annual Report on Form 10-K for fiscal year 2017, management determined that our internal control over financial reporting was not effective as of June 30, 2017 due to material weaknesses over monitoring and information and communication with respect to General Information Technology Controls (GITCs) for certain of our information technology platforms and flow of information from the component locations to allow for effective monitoring.
As a consequence, we did not have effective control activities over the establishment of GITCs for certain Information Technology (IT) platforms primarily at recently acquired locations, and which impacted manual controls that rely on data produced by or maintained within these IT system applications were also ineffective.
To remediate the material weaknesses in our internal control over financial reporting described in Item 9A of Part II of our Annual Report on Form 10-K for fiscal year 2017, we performed a comprehensive review of procedures and related controls.
We hired a new Internal Audit Director and expanded the existing Internal Audit to improve our monitoring processes.
We conducted various trainings and meetings to ensure there was clear flow of information from subsidiaries to the corporate headquarters.
As a result of our procedures, new process controls were designed and implemented during fiscal year 2018.
In addition, management focused on frequent testing of Information Technology General Controls to validate continued operating effectiveness.
Management has determined that the remediation actions discussed above were effectively designed and demonstrated effective operation for a sufficient period of time to enable us to conclude that the material weaknesses related to our monitoring and information and communication processes as well as the aforementioned internal control activities have been remediated as of June 30, 2018.
| (d) | Changes in Internal Control Over Financial Reporting |
We acquired Space Import-Export, Srl (“Space”) on July 1, 2016 and Advanced Cell Diagnostics (“ACD” on August 1, 2016, and we have implemented our internal control structure over these and incorporated its operations into our assessment of internal control over financial reporting as of June 30, 2018.
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
1 rewritten, 0 added, 0 removed, 0 unchanged
Other than "Executive Officers of the Registrant" which is set forth at the end of Item 1 in Part I of this report, the information required by Item 10 is incorporated herein by reference to the sections entitled "Election of Directors," "Principle Shareholders" and "Additional Corporate Governance Matters" in the Company's Proxy Statement for its [removed: 2018] [added: 2019] Annual Meeting of Shareholders which will be filed with the Securities and Exchange Commission pursuant to Regulation 14A within 120 days after the close of the fiscal year for which this report is filed.
Item 11. EXECUTIVE COMPENSATION
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by Item 11 is incorporated herein by reference to the sections entitled "Election of Directors" and "Executive Compensation" in the Company's Proxy Statement for its [removed: 2018] [added: 2019] Annual Meeting of Shareholders which will be filed with the Securities and Exchange Commission pursuant to Regulation 14A within 120 days after the close of the fiscal year for which this report is filed.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
1 rewritten, 0 added, 0 removed, 1 unchanged
The information required by Item 12 is incorporated by reference to the sections entitled "Principal Shareholders" and "Management Shareholdings" in the Company's Proxy Statement for its [removed: 2018] [added: 2019] Annual Meeting of Shareholders which will be filed with the Securities and Exchange Commission pursuant to Regulation 14A within 120 days after the close of the fiscal year for which this report is filed.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by Item 13 is incorporated by reference to the sections entitled "Election of Directors" and "Additional Corporate Governance Matters" in the Company's Proxy Statement for its [removed: 2018] [added: 2019] Annual Meeting of Shareholders which will be filed with the Securities and Exchange Commission pursuant to Regulation 14A within 120 days after the close of the fiscal year for which this report is filed.
Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
1 rewritten, 0 added, 0 removed, 1 unchanged
The information required by Item 14 is incorporated herein by reference to the section entitled "Audit Matters" in the Company's Proxy Statement for its [removed: 2018] [added: 2019] Annual Meeting of Shareholders which will be filed with the Securities and Exchange Commission pursuant to Regulation 14A within 120 days after the close of the fiscal year for which this report is filed.
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
5 rewritten, 57 added, 1 removed, 9 unchanged
Consolidated Statements of Earnings and Comprehensive Income for the Years Ended June 30, [added: 2019,] 2018, [removed: 2017,] and [removed: 2016][added: 2017]
Consolidated Balance Sheets as of June 30, [removed: 2018] [added: 2019] and [removed: 2017][added: 2018]
Consolidated Statements of Shareholders' Equity for the Years Ended June 30, [added: 2019,] 2018, [removed: 2017,] and [removed: 2016][added: 2017]
Consolidated Statements of Cash Flows for the Years Ended June 30, [added: 2019,] 2018, [removed: 2017,] and [removed: 2016][added: 2017]
Notes to Consolidated Financial Statements for the Years Ended June 30, [added: 2019,] 2018, [removed: 2017,] and [removed: 2016][added: 2017]
EXHIBIT INDEX
for Form 10-K for the 2019 Fiscal Year
| Exhibit Number | Description |
| --- | --- |
| 3.1 | [Amended and Restated Articles of Incorporation of the Company--incorporated by reference to Exhibit 3.1 of the Company's Form 10-Q dated February 9, 2015*](http://www.sec.gov/Archives/edgar/data/842023/000143774915002131/ex3-1.htm) |
| | |
| 3.2 | [Third Amended and Restated Bylaws of the Company--incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K dated February 1, 2018*](http://www.sec.gov/Archives/edgar/data/842023/000143774918001755/ex_104373.htm) |
| | |
| 10.1 | [Management Incentive Plan--incorporated by reference to Exhibit 10.13 of the Company's Form 10-K for the year ended June 30, 2013*](http://www.sec.gov/Archives/edgar/data/842023/000119312513351961/d545574dex1013.htm) |
| | |
| 10.2 | [Second Amended and Restated 2010 Equity Incentive Plan--incorporated by reference to Exhibit 10.1 of the Company's Form 8-K dated October 26, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917017673/ex_97613.htm) |
| | |
| 10.3 | [Form of Restricted Stock Award Agreement for Second Amended and Restated 2010 Equity Incentive Plan--incorporated by reference to Exhibit 10.6 of the Company's Form 8-K dated October 26, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917017673/ex_97618.htm) |
| | |
| 10.4 | [Form of Restricted Stock Unit Award Agreement for Second Amended and Restated 2010 Equity Incentive Plan attached as Exhibit 10.4 hereto](https://www.sec.gov/Archives/edgar/data/842023/000143774919017565/ex_156203.htm) |
| | |
| 10.5 | [Form of the Performance Unit Award Agreement for Second Amended and Restated 2010 Equity Incentive Plan attached as Exhibit 10.5 hereto](https://www.sec.gov/Archives/edgar/data/842023/000143774919017565/ex_156204.htm) |
| | |
| 10.6 | [Form of Incentive Stock Option Agreement for Second Amended and Restated 2010 Equity Incentive Plan--attached as Exhibit 10.6 hereto.](https://www.sec.gov/Archives/edgar/data/842023/000143774919017565/ex_156205.htm) |
| | |
| 10.7 | [Form of Employee Non-Qualified Stock Option Agreement for Second Amended and Restated 2010 Equity Incentive Plan--attached as Exhibit 10.7 hereto.](https://www.sec.gov/Archives/edgar/data/842023/000143774919017565/ex_156206.htm) |
| | |
| 10.8 | [Form of Director Non-Qualified Stock Option Agreement for Second Amended and Restated 2010 Equity Incentive Plan--incorporated by reference to Exhibit 10.2 of the Company's Form 8-K dated October 26, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917017673/ex_97614.htm) |
| | |
| 10.9 | [Employment Agreement by and between the Company and Charles Kummeth--incorporated by reference to Exhibit 10.11 of the Company's Form 10-K dated September 7, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917015711/ex10-11.htm) |
| Exhibit Number | Description |
| --- | --- |
| 10.10 | [Form of Employment Agreement by and between the Company and Executive Officers of the Company other than the CEO--incorporated by reference to Exhibit 10.12 of the Company's Form 10-K dated September 7, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917015711/ex10-12.htm) |
| | |
| 10.11 | [Credit Agreement by and among the Company, the Guarantors party thereto, the Lenders party thereto, and BMO Harris Bank N.A., as Administrative Agent, dated August 1, 2018--incorporated by reference to Exhibit 10.1 of the Company's Form 8-K dated August 2, 2018*](http://www.sec.gov/Archives/edgar/data/842023/000143774918014310/ex_119784.htm) |
| | |
| 10.12 | [Form of Indemnification Agreement entered into with each director and executive officer of the Company--incorporated by reference to Exhibit 10.1 of the Company's Form 10-Q dated February 8, 2018*](http://www.sec.gov/Archives/edgar/data/842023/000143774918001995/ex_104397.htm) |
| | |
| 10.13 | [Agreement and Plan of Merger by and among the Company, Aero Merger Sub Inc., Advanced Cell Diagnostics, Inc. and Fortis Advisors, LLC as the Securityholders’ Representative, dated July 6, 2016--incorporated by reference to Exhibit 2.1 of the Company's Form 8-K dated July 7, 2016*](http://www.sec.gov/Archives/edgar/data/842023/000143774916034990/ex2-1.htm) |
| | |
| 10.14 | [Agreement and Plan of Merger between the Company, Enzo Merger Sub. Inc., Exosome Diagnostics, Inc. and The Securityholders Representative, dated July 25, 2018--incorporated by reference to Exhibit 2.1 of the Company's Form 8-K dated June 25, 2018*](http://www.sec.gov/Archives/edgar/data/842023/000143774918012358/ex_116925.htm) |
| | |
| 21 | [Subsidiaries of the Company](https://www.sec.gov/Archives/edgar/data/842023/000143774919017565/ex_156245.htm) |
| --- | --- |
| | |
See "Exhibit Index" immediately following signature page.
An excerpt. Shown here: all 5 rewritten, 40 of 57 added and all 1 removed. The counts are complete. For every sentence, read Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES in the FY2019 filing and the FY2018 filing.
Item 16. FORM 10-K SUMMARY
10 rewritten, 2 added, 39 removed, 33 unchanged
| Date: August [removed: 27, 2018] [added: 28, 2019] | | /s/ Charles Kummeth | |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ Robert V. Baumgartner |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ Joseph Keegan, Ph.D. |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ John L. Higgins |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ Roeland Nusse, Ph.D. |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ Alpna Seth, Ph.D. |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ Randolph C. Steer, Ph.D., M.D. |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ Harold J. Wiens |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ Charles Kummeth |
| August [removed: 27, 2018] [added: 28, 2019] | /s/ James Hippel |
| August 28, 2019 | /s/ Rupert Vessey |
| | Dr. Rupert Vessey, Director |
| --- | --- |
| | |
| August 27, 2018 | /s/ Charles A. Dinarello, M.D. |
| | Dr. Charles A. Dinarello, Director |
EXHIBIT INDEX
for Form 10-K for the 2018 Fiscal Year
| Exhibit Number | Description |
| 3.1 | [Amended and Restated Articles of Incorporation of the Company--incorporated by reference to Exhibit 3.1 of the Company's Form 10-Q dated February 9, 2015*](http://www.sec.gov/Archives/edgar/data/842023/000143774915002131/ex3-1.htm) |
| 3.2 | [Third Amended and Restated Bylaws of the Company--incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K dated February 1, 2018*](http://www.sec.gov/Archives/edgar/data/842023/000143774918001755/ex_104373.htm) |
| 10.1 | [1998 Nonqualified Stock Option Plan--incorporated by reference to Exhibit 10.1 of the Company's Form 10-Q for the quarter ended September 30, 1998*](http://www.sec.gov/Archives/edgar/data/842023/0000842023-98-000006.txt) |
| 10.2 | [Form of Stock Option Agreement for 1998 Nonqualified Stock Option Plan--incorporated by reference to Exhibit 10.2 of the Company's Form 10-Q for the quarter ended September 30, 1998*](http://www.sec.gov/Archives/edgar/data/842023/0000842023-98-000006.txt) |
| 10.3 | [Management Incentive Plan--incorporated by reference to Exhibit 10.13 of the Company's Form 10-K for the year ended June 30, 2013*](http://www.sec.gov/Archives/edgar/data/842023/000119312513351961/d545574dex1013.htm) |
| 10.4 | [Second Amended and Restated 2010 Equity Incentive Plan--incorporated by reference to Exhibit 10.1 of the Company's Form 8-K dated October 26, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917017673/ex_97613.htm) |
| 10.5 | [Form of Restricted Stock Award Agreement for Second Amended and Restated 2010 Equity Incentive Plan--incorporated by reference to Exhibit 10.6 of the Company's Form 8-K dated October 26, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917017673/ex_97618.htm) |
| 10.6 | [Form of Restricted Stock Unit Award Agreement for Second Amended and Restated 2010 Equity Incentive Plan--incorporated by reference to Exhibit 10.7 of the Company's Form 8-K dated October 26, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917017673/ex_97619.htm) |
| 10.7 | [Form of the Performance Unit Award Agreement for Second Amended and Restated 2010 Equity Incentive Plan--incorporated by reference to Exhibit 10.5 of the Company's Form 8-K dated October 26, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917017673/ex_97617.htm) |
| 10.8 | [Form of Incentive Stock Option Agreement for Second Amended and Restated 2010 Equity Incentive Plan--attached as Exhibit 10.8 hereto.](https://www.sec.gov/Archives/edgar/data/842023/000143774918016190/ex_122658.htm) |
| 10.9 | [Form of Employee Non-Qualified Stock Option Agreement for Second Amended and Restated 2010 Equity Incentive Plan--attached as Exhibit 10.9 hereto.](https://www.sec.gov/Archives/edgar/data/842023/000143774918016190/ex_122659.htm) |
| 10.10 | [Form of Director Non-Qualified Stock Option Agreement for Second Amended and Restated 2010 Equity Incentive Plan--incorporated by reference to Exhibit 10.2 of the Company's Form 8-K dated October 26, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917017673/ex_97614.htm) |
| 10.11 | [Employment Agreement by and between the Company and Charles Kummeth--incorporated by reference to Exhibit 10.11 of the Company's Form 10-K dated September 7, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917015711/ex10-11.htm) |
| 10.12 | [Form of Employment Agreement by and between the Company and Executive Officers of the Company other than the CEO--incorporated by reference to Exhibit 10.12 of the Company's Form 10-K dated September 7, 2017*](http://www.sec.gov/Archives/edgar/data/842023/000143774917015711/ex10-12.htm) |
| 10.13 | [Agreement of Investment and Merger between the Company, Research and Diagnostics Systems, Inc., Cayenne Merger Sub, Inc., CyVek, Inc. and Citron Capital Limited dated April 1, 2014--incorporated by reference to Exhibit 10.22 of the Company's Form 10-K dated August 29, 2014*](http://www.sec.gov/Archives/edgar/data/842023/000119312514327566/d744730dex1022.htm) |
| 10.14 | [Credit Agreement by and among the Company, the Guarantors party thereto, the Lenders party thereto, and BMO Harris Bank N.A., as Administrative Agent, dated August 1, 2018--incorporated by reference to Exhibit 10.1 of the Company's Form 8-K dated August 2, 2018*](http://www.sec.gov/Archives/edgar/data/842023/000143774918014310/ex_119784.htm) |
| 10.15 | [Form of Indemnification Agreement entered into with each director and executive officer of the Company--incorporated by reference to Exhibit 10.1 of the Company's Form 10-Q dated February 8, 2018*](http://www.sec.gov/Archives/edgar/data/842023/000143774918001995/ex_104397.htm) |
| 10.16 | [Agreement and Plan of Merger by and among the Company, Aero Merger Sub Inc., Advanced Cell Diagnostics, Inc. and Fortis Advisors, LLC as the Securityholders’ Representative, dated July 6, 2016--incorporated by reference to Exhibit 2.1 of the Company's Form 8-K dated July 7, 2016*](http://www.sec.gov/Archives/edgar/data/842023/000143774916034990/ex2-1.htm) |
| 10.17 | [Agreement and Plan of Merger between the Company, Enzo Merger Sub. Inc., Exosome Diagnostics, Inc. and The Securityholders Representative, dated July 25, 2018--incorporated by reference to Exhibit 2.1 of the Company's Form 8-K dated June 25, 2018*](http://www.sec.gov/Archives/edgar/data/842023/000143774918012358/ex_116925.htm) |
| 21 | [Subsidiaries of the Company](https://www.sec.gov/Archives/edgar/data/842023/000143774918016190/ex_122876.htm) |
| 23 | [Consent of KPMG LLP, Independent Registered Public Accounting Firm](https://www.sec.gov/Archives/edgar/data/842023/000143774918016190/ex_122660.htm) |
| 31.1 | [Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002](https://www.sec.gov/Archives/edgar/data/842023/000143774918016190/ex_122661.htm) |
| 31.2 | [Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002](https://www.sec.gov/Archives/edgar/data/842023/000143774918016190/ex_122662.htm) |
| 32.1 | [Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002](https://www.sec.gov/Archives/edgar/data/842023/000143774918016190/ex_122663.htm) |
| 32.2 | [Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002](https://www.sec.gov/Archives/edgar/data/842023/000143774918016190/ex_122664.htm) |
| 101 | The following financial statements from the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2018, formatted in Extensible Business Reporting Language (XBRL): (i) the Consolidated Statements of Earnings and Comprehensive Income, (ii) the Consolidated Balance Sheets, (iii) the Consolidated Statements of Shareholders' Equity, (iv) the Consolidated Statements of Cash Flows, and (v) Notes to the Consolidated Financial Statements. |
\-------------
* Incorporated by reference; SEC File No. 000-17272
Management contract or compensatory plan or arrangement
Exhibits for Form 10-K have not been included in this report.
Exhibits have been filed with the Securities and Exchange Commission.
Upon request to the Investor Relations Department, Bio-Techne Corporation will furnish, without charge, any such exhibits as well as copies of periodic reports filed with the Securities and Exchange Commission.