BioLife Solutions (BLFS) 2020年年度報告「NASDAQ」.pdf

《BioLife Solutions (BLFS) 2020年年度報告「NASDAQ」.pdf》由會員分享，可在線閱讀，更多相關《BioLife Solutions (BLFS) 2020年年度報告「NASDAQ」.pdf（240頁珍藏版）》請在三個皮匠報告上搜索。

1、 Table of ContentsUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,DC 20549 FORM 10-K (Mark One)ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934For the year ended December 31,2020 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE

2、ACT OF 1934For the transition period from to Commission File Number 001-36362 BioLife Solutions,Inc.(Exact name of registrant as specified in its charter)Delaware94-3076866(State or other jurisdiction ofincorporation or organization)(IRS EmployerIdentification No.)3303 Monte Villa Parkway,Suite 310,

3、Bothell,Washington,98021(Address of registrants principal executive offices,Zip Code)(425)402-1400(Telephone number,including area code)Securities registered pursuant to Section 12(b)of the Act:Title of each classTrading symbol($)Name of exchange on which registeredCommon Stock,par value$0.01 per sh

4、areBLFSNASDAQ Capital Market Securities registered pursuant to Section 12(g)of the Act:None Indicate by check mark whether the registrant is a well-known seasoned issuer,as defined in Rule 405 of the Securities Act.Yes No Indicate by check mark whether the registrant is not required to file reports

5、pursuant to Section 13 or Section 15(d)of the Act.Yes No Indicate by check mark whether the registrant(1)has filed all reports required to be filed by Section 13 or 15(d)of the Securities Exchange Act of 1934 during thepreceding 12 months(or for such shorter period that the registrant was required t

6、o file such reports),and(2)has been subject to such filing requirements for the past90 days.Yes No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(S232.405 of this chapter)during th

7、e preceding 12 months(or for such shorter period that the Registrant was required to submit such said files).Yes No Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,a smaller reporting company or an emerginggrowth company.See the

8、 definitions of“large accelerated filer,”“accelerated filer,”“smaller reporting company,”and“emerging growth company”in Rule 12b-2 ofthe Exchange Act.Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company Emerging Growth Company If an emerging growth company,indica

9、te by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mark whether the registrant has filed a report on and attestation to it

10、s managements assessment of the effectiveness of its internal control overfinancial reporting under Section 404(b)of the Sarbanes-Oxley Act(15 U.S.C.7262(b)by the registered public accounting firm that prepared or issued its auditreport.Indicate by check mark whether the registrant is a shell compan

11、y(as defined in Rule 12b-2 of the Act).Yes No As of the registrants most recently completed second fiscal quarter,the aggregate market value of common equity(based on closing price on June 30,2020 of$16.35per share)held by non-affiliates was approximately$263 million.As of March 19,2021,33,401,359 s

12、hares of the registrants common stock were outstanding.Table of Contents Table of Contents Page No.PART I ITEM 1.BUSINESS4ITEM 1A.RISK FACTORS11ITEM 1B.UNRESOLVED STAFF COMMENTS21ITEM 2.PROPERTIES22ITEM 3.LEGAL PROCEEDINGS22ITEM 4.MINE SAFETY DISCLOSURES22 PART II ITEM 5.MARKET FOR REGISTRANTS COMMO

13、N EQUITY,RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OFEQUITY SECURITIES22ITEM 6.SELECTED CONSOLIDATED FINANCIAL DATA22ITEM 7.MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS23ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK33ITEM 8.CONSOLIDA

14、TED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA34 INDEX TO FINANCIAL STATEMENTS34 REPORTS OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS35ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE71ITEM 9A.CONTROLS AND PROCEDURES71ITEM 9B.OTHER INFORMATION72 PART

15、III ITEM 10.DIRECTORS,EXECUTIVE OFFICERS,AND CORPORATE GOVERNANCE73ITEM 11.EXECUTIVE COMPENSATION77ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDERMATTERS83ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE85ITEM 14.PRINCIPA

16、L ACCOUNTING FEES AND SERVICES85 PART IV ITEM 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES87ITEM 16.FORM 10-K SUMMARY88SIGNATURES89 2Table of Contents FORWARD LOOKING STATEMENTS This Annual Report on Form 10-K(“Form 10-K”or“Annual Report”)contains forward-looking statements which are made pursuant

17、to the safe harbor provisions ofSection 27A of the Securities Act of 1933,as amended,and Section 21E of the Securities Exchange Act of 1934,as amended(the“Exchange Act”).The forward-looking statements in this Form 10-K do not constitute guarantees of future performance and actual results could diffe

18、r materially from those contained in the forward-looking statements.These statements are based on current expectations of future events.Such statements include,but are not limited to,statements about our products,including our newly acquired products,customers,regulatory approvals,the potential util

19、ity of and market for our products and services,our ability to implement ourbusiness strategy and anticipated business and operations,in particular following our 2019 and 2020 acquisitions,future financial and operational performance,ouranticipated future growth strategy,including the closing of our

20、 merger with Global Cooling,Inc.and the acquisition of other synergistic cell and gene therapymanufacturing tools and services or technologies or other companies or technologies,capital requirements,intellectual property,suppliers,joint venture partners,future financial and operating results,the imp

21、act of the COVID-19 pandemic,plans,objectives,expectations and intentions,revenues,costs and expenses,interestrates,outcome of contingencies,business strategies,regulatory filings and requirements,the estimated potential size of markets,capital requirements,the terms of anycapital financing agreemen

22、ts and other statements that are not historical facts.You can find many of these statements by looking for words like“believes,”“expects,”“anticipates,”“estimates,”“may,”“should,”“will,”“could,”“plan,”“intend,”or similar expressions in this Form 10-K.We intend that such forward-lookingstatements be

23、subject to the safe harbors created thereby.These forward-looking statements are based on the current beliefs and expectations of our management and are subject to significant risks and uncertainties.Ifunderlying assumptions prove inaccurate or unknown risks or uncertainties materialize,actual resul

24、ts may differ materially from current expectations and projections.Factors that might cause such a difference include those discussed under“Risk Factors,”as well as those discussed elsewhere in the Form 10-K.You are cautioned not to place undue reliance on these forward-looking statements,which spea

25、k only as of the date of this Form 10-K or,in the case of documentsreferred to or incorporated by reference,the date of those documents.All subsequent written or oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by thecaut

26、ionary statements contained or referred to in this section.We do not undertake any obligation to release publicly any revisions to these forward-looking statementsto reflect events or circumstances after the date of this Form 10-K or to reflect the occurrence of unanticipated events,except as may be

27、 required under applicable U.S.securities law.If we do update one or more forward-looking statements,no inference should be drawn that we will make additional updates with respect to those orother forward-looking statements.References throughout this Form 10-K to“BioLife Solutions,Inc.”,“BioLife”,“w

28、e”,“us”,“our”,or the“Company”refer to BioLife Solutions,Inc.and its subsidiaries,taken as a whole,unless the context otherwise indicates.3Table of Contents PART I ITEM 1.BUSINESS The following discussion of our business contains forward-looking statements that involve risks and uncertainties(see the

29、 section entitled“Forward LookingStatements”herein).Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors,including thosefactors set forth under“Risk Factors”and elsewhere in this Form 10-K.Overview We develop,manufacture

30、,and market bioproduction tools and services to the cell and gene therapy(“CGT”)industry,which are designed to improve quality and de-risk biologic manufacturing and delivery.We also provide biological and pharmaceutical storage services to the CGT industry.Our products are used in basic andapplied

31、research,and commercial manufacturing of biologic-based therapies.Customers use our products to maintain the health and function of biologic materialduring sourcing,manufacturing,storage,and distribution of cells and tissues.We currently operate as one bioproduction tools and services business with

32、product lines that support several steps in the biologic material manufacturing and deliveryprocess.We have a diversified portfolio of tools and services that focus on biopreservation,frozen storage,and thawing of biologic materials.We have in-houseexpertise in cryobiology and continue to capitalize

33、 on opportunities to maximize the value of our product platform for our extensive customer base through bothorganic growth innovations and acquisitions.COVID-19 Considerations In March 2020,the World Health Organization declared the COVID-19 outbreak to be a pandemic.During 2020,we believe our quart

34、erly revenues were affected byCOVID-19.During the first quarter,our biopreservation media product lines benefited due to what we believe was safety stock purchasing by our customers due toCOVID-19.In the second and third quarters,we believe that revenues were negatively impacted by a reduction in cl

35、inical trial progression and temporary halts.Wethen noticed an increase of purchasing in biopreservation media in the fourth quarter as clinical trials and research lab activity resumed with reduced restrictions.Ourbiological and pharmaceutical services business that we acquired in the fourth quarte

36、r was in-line with expectations and we expect increased demand for biologicalmaterial storage with the reduction of COVID-19 restrictions.Our 2020 revenue was negatively affected for our automated thawing devices,cloud connected“smart”shipping containers,and freezer and storage technology lines of b

37、usiness by the COVID-19 pandemic due to restrictions on in-person selling,customer budget cuts forcapital equipment and lack of personnel at our customer sites to receive capital equipment.We have tried and,to date,have been successful in mitigating any supplychain problems.However,we cannot provide

38、 any assurance that a continued or prolonged global pandemic will not have a negative impact on our manufacturing andshipping processes or our product costs.The extent to which the COVID-19 pandemic affects our future financial results and operations will depend on futuredevelopments which are highl

39、y uncertain and cannot be predicted,including the recurrence,severity and/or duration of the ongoing pandemic,and current or futuredomestic and international actions to contain and treat COVID-19.We are following public and private sector policies and initiatives to reduce the transmission of COVID-

40、19,such as the imposition of travel restrictions and thepromotion of social distancing and work-from-home arrangements.We are taking a variety of measures to ensure the availability and functioning of our criticalinfrastructure,to promote the safety and security of our employees and to support the c

41、ommunities in which we operate.These measures include increasing our rawmaterials,manufacturing safety stock inventory for our biopreservation media and expanding availability of our biological and pharmaceutical storage,requiringremote working arrangements for employees who are not integral to phys

42、ically making and shipping our products or who do not need specialized equipment toperform their work,restricting on-site visits by non-employees and implementing social distancing protocols,and investing in personal protective equipment.Beginning April 2,2020 face masks were required to be worn by

43、all employees and contractors at all sites.Effective May 11,2020,temperature screening wasrequired upon entering our facilities where mandated by state law.Starting on May 11,2020,our employees were required to complete daily COVID-19 exposure andsymptom questionnaires where mandated,with the requir

44、ement rolling out companywide on October 13,2020 for all locations.For further discussion of the risks relating to COVID-19,see“Our financial condition and results of operations may be adversely affected by the COVID-19pandemic”in Item 1A.“Risk Factors”,below.Our Products Our bioproduction tools and

45、 services are comprised of five main offerings Biopreservation media Automated thawing devices Cloud connected“smart”shipping containers Freezer and storage technology and related components Biological and pharmaceutical material storage 4Table of Contents Biopreservation Media Our proprietary biopr

46、eservation media products,HypoThermosol FRS and CryoStor,are formulated to mitigate preservation-induced,delayed-onset cell damageand death,which result when cells and tissues are subjected to reduced temperatures.Our technology can provide our CGT customers with significant shelf lifeextension of b

47、iologic source material and final cell products,and can also greatly improve post-preservation cell and tissue viability and function.Our biopreservationmedia is serum-free,protein-free,fully defined,and manufactured under current Good Manufacturing Practices(cGMP).We strive to source wherever possi

48、ble,thehighest available grade,multi-compendium raw materials.We estimate our media products have been incorporated in over 450 customer clinical applications,including numerous chimeric antigen receptor(CAR)T cell and other cell types.Stability(i.e.shelf-life)and functional recovery are crucial asp

49、ects of academic research and clinical practice in the biopreservation of biologic-based source material,intermediate derivatives,and isolated/derived/expanded cellular products and therapies.Limited stability is especially critical in the CGT field,where harvested cellsand tissues will lose viabili

50、ty over time,if not maintained appropriately at normothermic body temperature(37C)or stored in a hypothermic state in an effectivepreservation medium.Chilling(hypothermia)is used to reduce metabolism and delay degradation of harvested cells and tissues.However,subjecting biologic materialto hypother

51、mic environments induces damaging molecular stress and structural changes.Although cooling successfully reduces metabolism(i.e.,lowers demand forenergy),various levels of cellular damage and death occur when using suboptimal methods.Traditional biopreservation media range from simple“balanced salt”(

52、electrolyte)formulations to complex mixtures of electrolytes,energy substrates such as sugars,osmotic buffering agents and antibiotics.The limited stability,whichresults from the use of these traditional biopreservation media formulations,is a significant shortcoming that our optimized proprietary p

53、roducts address with greatsuccess.Our scientific research activities over the last 20+years enabled a detailed understanding of the molecular basis for the hypothermic and cryogenic(low-temperatureinduced)damage/destruction of cells through apoptosis and necrosis.This research led directly to the de

54、velopment of our HypoThermosol FRS and CryoStortechnologies.Our proprietary biopreservation media products are specifically formulated to:Minimize cell and tissue swelling Reduce free radical levels upon formation Maintain appropriate low temperature ionic balances Provide regenerative,high energy s

55、ubstrates to stimulate recovery upon warming Avoid the creation of an acidic state(acidosis)Inhibit the onset of apoptosis and necrosis A key feature of our biopreservation media products is their“fully-defined”profile.All of our cGMP products are serum-free,protein-free and are formulated andfilled

56、 using aseptic processing.We strive to use USP/Multicompendial grade or the highest quality available synthetic components.All of these features benefitprospective customers by facilitating the qualification process required to incorporate our products into their regulatory filings.The results of in

57、dependent testing demonstrate that our biopreservation media products significantly extend shelf-life and improve cell and tissue post-thaw viabilityand function.Our products have demonstrated improved biopreservation outcomes,including greatly extended shelf-life and post-thaw viability,across a br

58、oad arrayof cell and tissue types.Competing biopreservation media products are often formulated with simple isotonic media cocktails,animal serum,potentially a single sugar or human protein.Akey differentiator of our proprietary HypoThermosol FRS formulation is the engineered optimization of the key

59、 ionic component concentrations for low temperatureenvironments,as opposed to normothermic body temperature around 37C,as found in culture media or saline-based isotonic formulas.Competing cryopreservationfreeze media is often comprised of a single permeating cryoprotectant such as dimethyl sulfoxid

60、e(“DMSO”).Our CryoStor formulations incorporate multiplepermeating and non-permeating cryoprotectant agents which allow for multiple mechanisms of protection and reduces the dependence on a single cryoprotectant.Webelieve that our products offer significant advantages over in-house formulations,or c

61、ommercial“generic”preservation media,including,time saving,improvedquality of components,more rigorous quality control release testing,more cost effective and improved preservation efficacy.We estimate that annual revenue from each customer commercial application in which our products are used could

62、 range from$500,000 to$2.0 million,if suchapplication is approved and our customer commences large scale commercial manufacturing of the biologic based therapy.5Table of Contents Automated,Water-Free Thawing Products In April 2019,we acquired Astero Bio Corporation(“Astero”),to expand our bioprocess

63、ing tools portfolio and diversify our revenue streams.The AsteroThawSTAR line includes automated vial and cryobag thawing products that control the heat and timing of the thawing process of biologic material.Ourcustomizable,automated,water-free thawing products uses algorithmic programmed,heating pl

64、ates to consistently bring biologic material from a frozen state to aliquid state in a controlled and consistent manner.This helps reduce damage during the temperature transition.The ThawSTAR products can reduce risks ofcontamination versus using a traditional water bath.evo Cloud Connected Shipping

65、 Containers In August 2019,we acquired the remaining shares of SAVSU Technologies,Inc.(“SAVSU”)we did not previously own.SAVSU is a leading developer and supplierof next generation cold chain management tools for cell and gene therapies.The evo.is cloud app allows biologic products to be traced and

66、tracked in real time.Ourevo platform consists of rentable cloud-connected shippers and include technologies that enable tracking software provides real-time information on geolocation,payload temperature,ambient temperature,tilt of shipper,humidity,altitude,and real-time alerts when a shipper has be

67、en opened.Our internally developed evo.issoftware allows customers to customize alert notifications both in data measurements and user requirements.The evo Dry Vapor Shipper(“DVS”)is specificallymarketed to cell and gene therapies.The evo DVS has improved form factor and ergonomics over the traditio

68、nal dewar,including extended thermal performance,reduced liquid nitrogen recharge time,improved payload extractors and ability to maintain temperature for longer periods on its side.We utilize couriers who already have established logistic channels and distribution centers.Our strategy greatly reduc

69、es the cash need to build out specialized facilitiesaround the world.Our partnerships with several white glove couriers allow us to scale our sales and marketing effort by utilizing their salesforce.Our courierpartnerships market our evo platform to their existing cell and gene therapy customers as

70、a cost effective and innovative solution.We also market directly to ourexisting and prospective customers who can utilize the evo platform through our courier partnerships.Liquid Nitrogen Freezer and Storage Devices In November 2019,we acquired Custom Biogenic Systems,Inc.(“CBS”)a global leader in t

71、he design and manufacture of state-of-the-art liquid nitrogen laboratoryfreezers,cryogenic equipment and accessories.The addition of CBS allows for product line growth,diversification of revenue and the potential for reduction of supplychain costs for our evo dry vapor shippers.Included in CBSs prod

72、uct line of liquid nitrogen freezers are the Isothermal LN2 freezers,constructed with a patented system which stores liquid nitrogen in ajacketed space in the walls of the freezer.This dry storage method eliminates liquid nitrogen contact with stored specimens,reduces the risk of cross-contamination

73、and provides increased user safety in a laboratory setting.To accommodate customer requirements,we offer customizable features including wide bodied andextended height.To accompany the offerings of cryogenic freezer equipment,we supply equipment for storing critically important biological materials.

74、This storage equipmentincludes upright freezer racks,chest freezer racks,liquid nitrogen freezer racks,canisters/cassettes and frames as well as laboratory boxes and dividers.Due to ouronsite design and manufacturing capability,racks and canisters can be customized to address customers varying requi

75、rements.In order to provide customers with a proactive approach to safety and monitoring of equipment containing liquefied gas,CBS offers Versalert,a patented wirelessremote asset monitoring system that can monitor and record temperatures.Versalert has an intelligent mesh network system that enables

76、 customers to view currentequipment conditions and receive alarm notification on smartphones,tablets or personal computers and maintain permanent electronic records for regulatorycompliance and legal verification.Biological and Pharmaceutical Storage In October 2020,we acquired SciSafe Holdings,Inc.

77、(“SciSafe”),a premier provider of biological and pharmaceutical storage.In addition to providing storageservices,SciSafe provides cold chain logistics that ensures materials are kept at target temperatures from the moment that the materials leave the customers premisesto their ultimate return.State-

78、of-the-art monitoring systems employed by SciSafe allow for customers to monitor the storage temperatures of their materials throughoutthe entire logistics chain.We operate four storage facilities in the USA.6Table of Contents Our Market Opportunity The CGT market has been rapidly expanding,treating

79、 diseases once thought incurable.According to the Alliance for Regenerative Medicine(“ARM”)there were over1,100 ongoing clinical trials utilizing regenerative medicine at the end of 2020.ARM also states there were over$19.9 billion in total global financings in theregenerative market in 2020.The FDA

80、 predicts ten to twenty cell and gene therapies per year will be approved by 2025.These technologies change the way physicians treat patients.The manufacturing,distribution and the delivery process is significantly different from many other typesof medicines and therapies.We believe we are well posi

81、tioned to address many of the manufacturing difficulties in the process of producing cell and gene therapies.The Bioproduction Process Our products currently fulfill several steps in the bioproduction process for cell and gene therapies.See the diagram below from an illustration of this process and

82、ourproduct roles.We now offer products that integrate into the critical steps of preservation,thawing,fixed storage,and transportable storage under controlled conditions.Complementary Products PortfolioExpanding Participation in Customers Workflow Our Strategy We aggressively leverage our numerous r

83、elationships with the leading cell and gene therapy companies that use our expanded product portfolio of bioproduction toolsto cross-sell our portfolio of products and services.Over the last several years,we have built a strong reputation as a trusted supplier of critical tools used in cell andgene

84、therapy manufacturing.We believe that our relationships and reputation could enable us to drive incremental revenue growth through the sale of additionalproducts to a captive customer base.Our products are designed to increase our customers product yield and functionality,and we are committed to sup

85、porting ourcustomers with strong customer service and our expertise associated with the clinical applications of our products.7Table of Contents Business Operations Research and Development Our research and development activity is focused on evaluating new potential disruptive technologies which may

86、 be applicable throughout the cell and gene therapymanufacturing workflow.We routinely assess and analyze the strengths and weaknesses of competitive products and are typically engaged in business developmentdiscussions on an ongoing basis.We strive to continue to introduce differentiated and high-q

87、uality products that address specific difficulties in the biologic storagepreservation and thawing process.Sales and Marketing We market and sell our products through direct sales and third-party distribution.We have experienced field-based sales employees who market our growing product portfolio on

88、 a direct basis.Over time,we anticipate expanding our sales team.Ourtechnical applications engineers and customer care support teams have extensive experience in cell processing,biopreservation,freezing and thawing.In the years ended December 31,2020 and 2019,we derived approximately 13%of our reven

89、ue from one customer and approximately 15%of our revenue from onecustomer,respectively.Our products are marketed and distributed by STEMCELL Technologies,MilliporeSigma,VWR,Thermo Fisher and several other regional distributors under non-exclusive agreements.In 2020,sales to third party distributors

90、accounted for 45%of our revenue compared to 46%in 2019.The following table represents the Companys total revenue by geographic area(based on the location of the customer):Year Ended December 31,Revenue by customers geographic locations 2020 2019 United States 73%69%Canada 13%16%Europe,Middle East,Af

91、rica(EMEA)12%14%Other 2%1%Total revenue 100%100%Manufacturing Biopreservation Media-We maintain and operate two independent cGMP clean room production suites for manufacturing sterile biopreservation media products inBothell,Washington.Our quality management system(“QMS”)is certified to the ISO 1348

92、5:2016 standard.Our QMS is aligned with applicable sections of 21 CFRPart 820-Quality System Regulation for Good Manufacturing Practice of medical devices,21 CFR Parts 210 and 211-cGMP for Finished Pharmaceuticals,FDAGuidance-Sterile Drug Products,Volume 4,EU Guidelines Annex 1-Manufacture of Steril

93、e Medicinal Products,ISO 13408-Aseptic Processing of HealthcareProducts,and ISO 14644-Clean Rooms and Associated Controlled Environments.We seek to manage single-source supplier risk by regularly assessing the qualityand capacity of our suppliers,implementing supply and quality agreements where appr

94、opriate and actively managing lead times and inventory levels of sourcedcomponents.Pursuant to our supply agreements,we are required to notify customers of any changes to our raw materials.For certain components in which we do nothave a secondary supplier,we estimate that it would take up to six mon

95、ths to find and qualify a second source.Order quantities and lead times for externally sourcedcomponents are based on our forecasts,which are derived from historical demand and anticipated future demand.Lead times for components may vary depending onthe size of the order,specific supplier requiremen

96、ts and current market demand for the materials and parts.Due to COVID-19,we have seen increased lead times forcertain raw materials,particularly personal protective equipment used in our clean rooms and certain form factors of bottles and vials used in our finished products.Todate,we have not experi

97、enced significant difficulties in obtaining raw materials for the manufacture of our biopreservation media products.Automated Thawing Our ThawSTAR automated,water-free thawing products are produced by a contract manufacturing organization(“CMO”)based in the UnitedStates.We believe this CMO has the s

98、kills,experience and capacity needed to meet our quality standards and demand expectations for the product line.Due toCOVID-19,we have seen increased lead times from our CMO due to increased lead times from our CMOs suppliers.We estimate that it would take up to six monthsto find and qualify an alte

99、rnative CMO.To date,we have not experienced significant difficulties in obtaining our automated thaw products from our CMO.evo Cold Chain Products Production of our evo cold chain management hardware products is performed by external CMOs and by personnel in our Albuquerque,New Mexico facility.Our Q

100、MS is certified to the ISO 9001:2015 standard.Due to COVID-19,we have seen increased lead times for certain raw materials andcomponents from our suppliers.To date,we have not experienced significant difficulties in obtaining raw materials for the manufacture of our evo cold chain products.8Table of

101、Contents Freezer and Storage The majority of our CBS freezers and related accessories are manufactured in our facility in Bruce Township,Michigan.We are reliant oncertain critical suppliers for some components.Due to COVID-19,we have seen increased lead times for certain raw materials and components

102、 from our suppliers aswell as increased costs on certain raw materials.To date,we have not experienced significant difficulties in obtaining raw materials for the manufacture of our freezerand storage products.We practice continuous improvement based on routine internal audits as well as external fe

103、edback and audits performed by our partners and customers.In addition,wemaintain a business continuity management system that focuses on key areas such as contingency planning,security stocks and off-site storage of raw materials andfinished goods to ensure continuous supply of our products.Biologic

104、al storage Biological and Pharmaceutical Storage SciSafe operates three cGMP compliant storage facilities and two other state-of-the-art facilities in the United States.Twofacilities are certified to the ISO 20387:2018 standard.We rely on outside suppliers for the build out of our cold-storage chamb

105、ers and stand-alone freezers.Due toCOVID-19,we have experienced increased lead times in acquiring stand-alone freezers,which we use to store customers biologic materials.Product Regulatory Status Our media,thawing,freezer,and evo products are not subject to any specific United States Food and Drug A

106、dministration(“FDA”)or other international marketingregulations for drugs,devices,or biologics.We are not required to sponsor formal prospective,controlled clinical trials in order to establish safety and efficacy.However,to support our current and prospective clinical customers,we manufacture and r

107、elease our products in compliance with cGMP and other relevant qualitystandards.To assist customers with their regulatory applications,we maintain Type II Master Files at the FDA for CryoStor,HypoThermosol FRS,BloodStor 27,and our CellThawing Media products,which provide the FDA with information reg

108、arding our manufacturing facility and process,our quality system,stability and safety,and anyadditional testing that has been performed.Customers engaged in clinical and commercial applications may notify the FDA of their intention to use our products intheir product development and manufacturing pr

109、ocess by requesting a cross-reference to our master files.One freezer in our Customer Biogenic Systems product line is currently regulated as a Class 2 medical device in the EU.Intellectual Property The following table lists our granted and pending patents.We have also obtained certain trademarks an

110、d tradenames for our products to distinguish our genuineproducts from our competitors products and we maintain certain details about our processes,products,and strategies as trade secrets.While we believe that theprotection of patents and trademarks is important to our business,we also rely on a com

111、bination of trade secrets,nondisclosure and confidentiality agreements,scientific expertise and continuing technological innovation to maintain our competitive position.Despite these precautions,it may be possible for unauthorized thirdparties to copy certain aspects of our products and/or to obtain

112、 and use information that we regard as proprietary(see“Item 1A.Risk Factors”of this Annual Reportfor additional details).The laws of some foreign countries in which we may sell our products do not protect our proprietary rights to the same extent as do the laws ofthe United States.Issued PatentsPate

113、nts Applied ForRegistered TrademarksMedia and thaw313217evo cold chain1166Freezers and accessories136Storage services-1Total434130 Competition Our bioproduction products and services compete on the basis of value proposition,performance,quality,cost effectiveness,and application suitability with num

114、erousestablished technologies.Additional products using new technologies that may be competitive with our products may also be introduced.Many of the companiesselling or developing competitive products have greater financial and human resources,R&D,manufacturing and marketing experience than we do.T

115、hey mayundertake their own development of products that are substantially similar to or compete with our products and they may succeed in developing products that are moreeffective or less costly than any that we may develop.These competitors may also prove to be more successful in their production,

116、marketing and commercializationactivities.We cannot be certain that the research,development and commercialization efforts of our competitors will not render any of our existing or potentialproducts obsolete.9Table of Contents Recent Developments On March 19,2021,we entered into an Agreement and Pla

117、n of Merger(the“Merger Agreement”)by and between us,BLFS Merger Subsidiary,Inc.,our wholly-owned subsidiary(“Merger Sub”),and Global Cooling,Inc.(“Global Cooling”)pursuant to which Merger Sub will merge with and into Global Cooling,with GlobalCooling continuing as the surviving entity and a wholly-o

118、wned subsidiary of the Company(the“GCI Merger”).The total consideration to be paid by us to thestockholders of Global Cooling at the closing will be 6,646,870 shares of our common stock(representing 19.9%of the number of our shares of common stock issuedand outstanding immediately prior to the date

119、of the execution of the Merger Agreement),a portion of which will be held in two segregated escrow accounts to serveas the sole source of payment for post-closing indemnification claims.The Merger Agreement provides for mutual indemnification,subject,in certain instances,to abasket and cap.The closi

120、ng of the GCI Merger is subject to various customary closing conditions,including the approval of Global Coolings stockholders,and maybe terminated by mutual agreement,for the other partys uncured material breach,or if there is a government order preventing the closing,among other reasons.Thereis no

121、 assurance that the GCI Merger will close or that,if the GCI Merger does close,it will be successful or that Global Cooling will be,or will remain,profitable.Formore information regarding the GCI Merger,please see our Current Report on Form 8-K filed on March 25,2021.For further discussion of the ri

122、sks relating to theGCI Merger,see“Risks Related to our Acquisition Strategy”in Item 1A.“Risk Factors”,below.Human Capital We view our employees and our culture as key to our success.As of December 31,2020,we had 193 full time employees and 6 part-time employees.Our employeesare not covered by any co

123、llective bargaining agreement.We consider relations with our employees to be good.Corporate History We were incorporated in Delaware in 1987 under the name Trans Time Medical Products,Inc.In 2002,the Company,then known as Cryomedical Sciences,Inc.wasengaged in manufacturing and marketing cryosurgica

124、l products.The entity was merged with our wholly-owned subsidiary,BioLife Solutions,Inc.,which was engagedas a developer and marketer of biopreservation media products for cells and tissues.Following the merger,we changed our name to BioLife Solutions,Inc.Principal Offices;Available Information Our

125、principal executive offices are located at 3303 Monte Villa Parkway,Suite 310,Bothell,Washington 98021 and the telephone number is(425)402-1400.Wemaintain a website at .The information contained on or accessible through our website is not part of this Annual Report on Form 10-K andis not incorporate

126、d in any manner into this Annual Report.Our Annual Report on Form 10-K,Quarterly Reports on Form 10-Q,Current Reports on Form 8-K andamendments to reports filed or furnished pursuant to Sections 13(a)and 15(d)of the Securities Exchange Act of 1934(the“Exchange Act”),are available free ofcharge on ou

127、r website as soon as reasonably practicable after we electronically file such reports with,or furnish those reports to,the Securities and ExchangeCommission(the“SEC”).The SEC also maintains an Internet site that contains reports,proxy and information statements,and other information regarding issuer

128、s thatfile electronically with the SEC at http:/www.sec.gov.10Table of Contents ITEM 1A.RISK FACTORS Investing in our common stock involves a high degree of risk.You should carefully consider the risks and uncertainties described below,together with all of the otherinformation contained in this Annu

129、al Report,before deciding to invest in our common stock.If any of the following risks materialize,our business,financial condition,results of operation and prospects will likely be materially and adversely affected.In that event,the market price of our common stock could decline and you couldlose al

130、l or part of your investment.Risks Related to our Financial Condition The majority of our net product revenue come from a relatively small number of customers and products in a limited number of market sectors;if we lose any ofthese customers or if there are problems in those market sectors,particul

131、arly as a result of the COVID-19 pandemic,our net product revenue and operatingresults could decline significantly.In the years ended December 31,2020 and 2019,we derived approximately 13%and 15%of our revenue from one customer,respectively.No other customeraccounted for more than 10%of revenue in t

132、he years ended December 31,2020 or 2019.In the years ended December 31,2020 and 2019,we derived approximately60%and 74%of our revenue from CryoStor products,respectively.Due to our acquisitions in 2020 and 2019,and our expected merger with Global Cooling in 2021,we expect both our revenue concentrat

133、ion related to CryoStor,and our customer concentration to be reduced for the year ending December 31,2021.Our principalcustomers may vary from period to period and such customers may not continue to purchase products from us at current levels or at all(particularly as a result of theCOVID-19 pandemi

134、c).Further,the inability of some of our customers to consummate anticipated purchases of our products due to changes in end-user demand,andother unpredictable factors that may affect customer ordering patterns could lead to significant reductions in net product revenue which could harm our business.

135、Because our revenue and operating results are difficult to predict(particularly as a result of the COVID-19 pandemic),we believe that period-to-period comparisons ofour results of operations are not a good indicator of our future performance.Additionally,if revenue declines in a quarter,whether due

136、to a delay in recognizingexpected revenue,adverse economic conditions,the COVID-19 pandemic or otherwise,our results of operations will be harmed because many of our expenses arerelatively fixed.In particular,a large portion of our manufacturing costs,our research and development,sales and marketing

137、 and general and administrative expensesare not significantly affected by variations in revenue.Further,our cost of product revenue is dependent on product mix.If our quarterly operating results fail to meetinvestor expectations,the price of our common stock may decline.We expect our operating resul

138、ts to fluctuate significantly from period to period.Following our acquisitions in 2020 and 2019,we have increased our fixed costs and now sell products having higher costs of product revenue than our biopreservationmedia products.We expect that the result of these acquisitions will make it more diff

139、icult to predict our revenue and operating results from period-to-period and that,as a result,comparisons of our results of operations are not currently and will not be for the foreseeable future a good indicator of our future performance.Forexample,if revenue declines in a quarter,whether due to a

140、delay in recognizing expected revenue,adverse economic conditions,the COVID-19 pandemic orotherwise,our results of operations in such period will be harmed because many of our expenses are now relatively fixed.In particular,a large portion of ourmanufacturing costs,research and development expenses,

141、sales and marketing expenses and general and administrative expenses are not significantly affected byvariations in revenue.Further,a shift in product revenue concentration away from our CryoStor products and towards our new products with higher costs of productrevenue will adversely affect our oper

142、ating margin.If our quarterly operating results fail to meet investor expectations,the price of our common stock may decline.Risks Related to our Acquisition Strategy and the GCI Merger We may engage in future acquisitions or strategic transactions which may require us to seek additional financing o

143、r financial commitments,increase ourexpenses and/or present significant distractions to our management.In fiscal 2020 and 2019,we acquired four companies and made investments in three other companies(including a follow-on investment in one company).Additionally,on March 19,2021,we entered into an ag

144、reement and plan of merger with Global Cooling to acquire all of the shares of Global Cooling,which weexpect to close,subject to receipt of approval from the stockholders of Global Cooling and certain regulatory approvals,on or prior to May 1,2021.We are continuingto actively evaluate opportunities

145、to grow our portfolio of cell and gene therapy tools.In the event we engage in an acquisition or strategic transaction,including bymaking an investment in another company,we may need to acquire additional financing.Obtaining financing through the issuance or sale of additional equity and/ordebt secu

146、rities,if possible,may not be at favorable terms and may result in additional dilution to our current stockholders.Additionally,any such transaction mayrequire us to incur non-recurring or other charges,may increase our near and long-term expenditures and may pose significant integration challenges

147、or disrupt ourmanagement or business,which could adversely affect our operations and financial results.For example,an acquisition or strategic transaction,including the mergerwith Global Cooling,may entail numerous operational and financial risks,including the risks outlined above and additionally:e

148、xposure to unknown liabilities;disruption of our business and diversion of our managements time and attention in order to develop acquired products or technologies;higher than expected acquisition and integration costs;write-downs of assets or goodwill or impairment charges;increased amortization ex

149、penses;difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership;and inability to retain key employees of

150、 any acquired businesses.11Table of Contents Accordingly,although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above,including the GlobalCooling transaction,any transactions that we do complete could have a material adverse effect

151、 on our business,results of operations,financial condition and prospects.If intangible assets and goodwill that we recorded in connection with our acquisitions become impaired,we may have to take significant charges against earnings.In connection with the accounting for our completed acquisitions in

152、 2020 and 2019,we recorded a significant amount of intangible assets,including developedtechnology and customer relationships relating to the acquired product lines,and goodwill.Under U.S.GAAP,we must assess,at least annually and potentially morefrequently,whether the value of intangible assets and

153、goodwill has been impaired.Intangible assets and goodwill will be assessed for impairment in the event of animpairment indicator.Any reduction or impairment of the value of intangible assets and goodwill will result in a charge against earnings,which could materiallyadversely affect our results of o

154、perations and shareholders equity in future periods.Our acquisitions expose us to risks that could adversely affect our business,and we may not achieve the anticipated benefits of acquisitions of businesses ortechnologies.As a part of our growth strategy,we have made and may continue to make selecte

155、d acquisitions of complementary products and/or businesses,including the expectedmerger with Global Cooling.Any acquisition involves numerous risks and operational,financial,and managerial challenges,including the following,any of whichcould adversely affect our business,financial condition,or resul

156、ts of operations:difficulties in integrating new operations,technologies,products,and personnel;problems maintaining uniform procedures,controls and policies with respect to our financial accounting systems;lack of synergies or the inability to realize expected synergies and cost-savings;difficultie

157、s in managing geographically dispersed operations,including risks associated with entering foreign markets in which we have no or limited priorexperience;underperformance of any acquired technology,product,or business relative to our expectations and the price we paid;negative near-term impacts on f

158、inancial results after an acquisition,including acquisition-related earnings charges;the potential loss of key employees,customers,and strategic partners of acquired companies;claims by terminated employees and shareholders of acquired companies or other third parties related to the transaction;the

159、assumption or incurrence of additional debt obligations or expenses,or use of substantial portions of our cash;the issuance of equity securities to finance or as consideration for any acquisitions that dilute the ownership of our stockholders(which in the case ofGlobal Cooling,is significant);the is

160、suance of equity securities to finance or as consideration for any acquisitions may not be an option if the price of our common stock is low or volatilewhich could preclude us from completing any such acquisitions;diversion of managements attention and company resources from existing operations of t

161、he business;inconsistencies in standards,controls,procedures,and policies;the impairment of intangible assets as a result of technological advancements,or worse-than-expected performance of acquired companies;assumption of,or exposure to,historical liabilities of the acquired business,including unkn

162、own contingent or similar liabilities that are difficult to identifyor accurately quantify;and risks associated with acquiring intellectual property,including potential disputes regarding acquired companies intellectual property.12Table of Contents In addition,the successful integration of acquired

163、businesses requires significant efforts and expense across all operational areas,including sales and marketing,research and development,manufacturing,finance,legal,and information technologies.There can be no assurance that any of the acquisitions we may make will besuccessful or will be,or will rem

164、ain,profitable.Our failure to successfully address the foregoing risks may prevent us from achieving the anticipated benefits from anyacquisition in a reasonable time frame,or at all.The closing of the GCI Merger is subject to various closing conditions,including the receipt of stockholder approval

165、from the Global Cooling Stockholders,and ifthese conditions are not met or waived,we will not be able to close the GCI Merger which may adversely affect our business,financial results and stock price.The Merger Agreement provides that various closing conditions must be met before the GCI Merger will

166、 close including,but not limited to,receipt of stockholderapproval from the Global Cooling stockholders and receipt of certain regulatory approvals.If these closing conditions are not met or waived,if permissible,we willnot be able to close the GCI Merger.If the GCI Merger is not completed,our ongoi

167、ng business may be adversely affected and we could see an impact on our financialresults and stock price.The integration of Global Cooling after the GCI Merger may result in significant accounting charges that adversely affect the announced results of our company.The financial results of our company

168、 may be adversely affected by cash expenses and non-cash accounting charges incurred in connection with the GCI Merger.Inaddition to the anticipated cash charges,costs associated with the amortization of intangible assets are expected.The parties are in the process of preparing pro formafinancial st

169、atements that reflect the effects of the GCI Merger and,accordingly,the amount and timing of these possible charges are not yet known.The price of ourcommon stock could decline to the extent our financial results are materially affected by the foregoing charges or if the foregoing charges are larger

170、 than anticipated.The announcement and pendency of the GCI Merger could cause disruptions in the businesses of our company and Global Cooling which could have an adverseeffect on our and their business and financial results both prior to and after the closing of the GCI Merger.Each party has operate

171、d and,until the completion of the GCI Merger,will continue to operate independently.Uncertainty about the effect of the GCI Merger onemployees,customers,distributors and suppliers may have an adverse effect on us and Global Cooling both prior to and following closing of the GCI Merger.Theseuncertain

172、ties may impair each parties ability to retain and motivate key personnel and could cause customers,distributors,suppliers and others with whom eachcompany deals to seek to change existing business relationships which may materially and adversely affect their respective businesses.Due to the materia

173、litystandards agreed to by the parties in the Merger Agreement,each party may be obligated to consummate the GCI Merger in spite of the adverse effects resulting fromthe disruption of our and Global Coolings ongoing businesses.Furthermore,this disruption could adversely affect our ability to maintai

174、n relationships with our andtheir customers,distributors,suppliers and employees after the GCI Merger or to achieve the anticipated benefits of the GCI Merger.Moreover,integration effortsbetween the two companies will also divert management attention and resources.These integration matters could hav

175、e an adverse effect on each party.Each of theseevents could adversely affect us,in the near term and,if the GCI Merger is completed,thereafter.The regulatory approvals required to close the GCI Merger may not be obtained or may contain materially burdensome conditions.Completion of the GCI Merger is

176、 conditioned upon the receipt of certain governmental approvals,including the expiration or termination of the applicable antitrustwaiting periods,and any extension of the waiting periods.Although the parties have agreed in the Merger Agreement to use their best efforts to obtain the requisitegovern

177、mental approvals,there can be no assurance that these approvals will be obtained.In addition,the governmental entities from which these approvals arerequired may impose conditions on the completion of the GCI Merger or require changes to the terms of the GCI Merger.While the parties do not currently

178、 expect thatany such conditions or changes would be imposed,there can be no assurance that they will not be,and such conditions or changes could have the effect ofjeopardizing or delaying completion of the GCI Merger or reducing the anticipated benefits of the GCI Merger.If either party agrees to an

179、y material conditions inorder to obtain any approvals required to complete the GCI Merger,the business and results of operations of the combined company may be adversely affected.13Table of Contents The GCI Merger may result in unexpected consequences to our business and results of operations.Althou

180、gh Global Coolings business will generally be subject to risks similar to those to which we are subject to in our existing operations,we may not havediscovered all risks applicable to Global Coolings business during the due diligence process and such risks may not be discovered prior to closing.Some

181、 of theserisks could produce unexpected and unwanted consequences for us.Undiscovered risks may result in us incurring financial liabilities,which could be material andhave a negative impact on our business operations.Failure to realize the benefits expected from the GCI Merger could adversely affec

182、t the value of our common stock.The success of the GCI Merger will depend,in part,on our ability to:capitalize on our cross-selling opportunities by leveraging our extensive relationships with cell and gene therapy companies to drive sales of GlobalCoolings freezers and leveraging Global Coolings re

183、lationships with its customers to offer them our full portfolio of bioproduction tools and services;realize the anticipated cost savings from vertical integration of our synergies including lower capital costs in deploying Global Coolings freezers inSciSafe global biorepositories,expanding manufactu

184、ring capacity for Global Coolings freezers at our CBS facilities and expanding the reach of the GlobalCooling sales team and distributors to provide access to our entire portfolio of bioproduction tools and services offered to the cell and gene therapy andbiopharma markets;and realize cost savings f

185、rom reduced back-office and infrastructure expenses,elimination of duplicative company and management structure costs,andimproved purchasing power through greater scale.However,to realize the anticipated benefits of the GCI Merger we must successfully integrate the business of Global Cooling in a ma

186、nner that permits those benefitsand cost savings to be realized.Although we expect significant benefits to result from the GCI Merger,there can be no assurance that we will be able to successfullyrealize these benefits.The challenges involved in this integration,which will be complex and time consum

187、ing.If we do not successfully manage these and relatedissues and challenges,we may not achieve the anticipated benefits of the GCI Merger and our revenue,expenses,operating results,financial condition and stock pricecould be materially adversely affected.Risks Related to our Business and Operations

188、Healthcare reform measures could adversely affect our business.The efforts of governmental and third-party payors to contain or reduce the costs of healthcare may adversely affect the business and financial condition ofpharmaceutical and biotechnology companies,including ours.Specifically,in both th

189、e United States and some foreign jurisdictions,there have been a number oflegislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.Efforts by governments andother third-party payors to contain or reduce the costs of he

190、althcare through various means may limit our commercial opportunities and adversely affect our operatingresults and result in a decrease in the price of our common stock or limit our ability to raise capital.If our products do not perform as expected or the reliability of the technology on which our

191、 products are based is questioned,we could experience lost revenue,delayed or reduced market acceptance of our products,increased costs and damage to our reputation.Our success depends on the markets confidence that we can provide reliable,high-quality products to our customers.We believe that custo

192、mers in our target marketsare likely to be particularly sensitive to product defects and errors.Our reputation and the public image of our products and technologies may be impaired if ourproducts fail to perform as expected.Although our products are tested prior to shipment,defects or errors could n

193、onetheless occur in our products.In the future,if ourproducts experience,or are perceived to experience,a material defect or error,this could result in loss or delay of revenues,delayed market acceptance,damagedreputation,diversion of development resources,legal claims,increased insurance costs or i

194、ncreased service and warranty costs,any of which could harm our business.Such defects or errors could also narrow the scope of the use of our products,which could hinder our success in the market.Even after any underlying concerns orproblems are resolved,any lingering concerns in our target market r

195、egarding our technology or any manufacturing defects or performance errors in our products couldcontinue to result in lost revenue,delayed market acceptance,damaged reputation,increased service and warranty costs and claims against us.We face significant competition.The life sciences industry is hig

196、hly competitive.We anticipate that we will continue to face increased competition as existing companies may choose to develop newor improved products and as new companies could enter the market with new technologies,any of which could compete with our product or even render our productsobsolete.Many

197、 of our competitors are significantly larger than us and have greater financial,technical,research,marketing,sales,distribution and other resources thanus.There can be no assurance that our competitors will not succeed in developing or marketing technologies and products that are more effective or c

198、ommerciallyattractive than any that are being developed or marketed by us,or that such competitors will not succeed in obtaining regulatory approval,or introducing orcommercializing any such products,prior to us.Such developments could have a material adverse effect on our business,financial conditi

199、on and results of operations.Also,even if we can compete successfully,there can be no assurance that we can continue do so in a profitable manner.14Table of Contents We are dependent on outside suppliers for all our manufacturing supplies.We rely on outside suppliers for all our manufacturing suppli

200、es,parts and components.Although we believe we could develop alternative sources of supply for mostof these components within a reasonable period of time,there can be no assurance that,in the future,our current or alternative sources will be able to meet all ourdemands on a timely basis,particularly

201、 given the uncertainty surrounding the COVID-19 pandemic.Unavailability of necessary components could require us to re-engineer our products to accommodate available substitutions,which could increase costs to us and/or have a material adverse effect on manufacturing schedules,products performance a

202、nd market acceptance.In addition,an uncorrected defect or suppliers variation in a component or raw material,either unknown to us orincompatible with our manufacturing process,could harm our ability to manufacture products.We might not be able to find a sufficient alternative supplier in areasonable

203、 amount of time,or on commercially reasonable terms,if at all.If we fail to obtain a supplier for the components of our products,our operations could bedisrupted.Our success will depend on our ability to attract and retain key personnel.In order to execute our business plan,we must attract,retain an

204、d motivate highly qualified managerial,scientific,manufacturing,and sales personnel.If we fail toattract and retain skilled scientific and sales personnel,our sales efforts will be hindered.Our future success depends to a significant degree upon the continuedservices of key scientific and technical

205、personnel.If we do not attract and retain qualified personnel,we will not be able to achieve our growth objectives.Difficulties in manufacturing could have an adverse effect upon our expenses and our product revenues.We currently manufacture all of our biopreservation media products,freezer products

206、 and related components.We currently outsource most of the manufacturing ofour ThawSTAR and evo products.The manufacturing of our products is difficult and complex.To support our current and prospective clinical customers,we complywith and intend to continue to comply with cGMP in the manufacture of

207、 our products.Our ability to adequately manufacture and supply our products in a timelymatter is dependent on the uninterrupted and efficient operation of our facilities and those of third-parties producing raw materials and supplies upon which we rely inour manufacturing.The manufacture of our prod

208、ucts may be impacted by:availability or contamination of raw materials and components used in the manufacturing process,particularly those for which we have no other sourceor supplier;the ongoing capacity of our facilities;our ability to comply with new regulatory requirements,including our ability

209、to comply with cGMP;inclement weather and natural disasters;changes in forecasts of future demand for product components;potential facility contamination by microorganisms or viruses;updating of manufacturing specifications;product quality success rates and yields;and global viruses and pandemics,in

210、cluding the current COVID-19 pandemic.If efficient manufacture and supply of our products is interrupted,we may experience delayed shipments or supply constraints.If we are at any time unable to providean uninterrupted supply of our products to customers,our customers may be unable to supply their e

211、nd-products incorporating our products to their patients and othercustomers,which could materially and adversely affect our product revenue and results of operations.While we are not currently subject to FDA or other regulatory approvals on our products,if we become subject to regulatory requirement

212、s,the manufacture andsale of our products may be delayed or prevented,or we may become subject to increased expenses.None of our products are subject to FDA.In particular,we are not required to sponsor formal prospective,controlled clinical-trials to establish safety and efficacy.Additionally,we com

213、ply with cGMP requirements.This is done solely to support our current and prospective clinical customers.However,there can be no assurancethat we will not be required to obtain approval from the FDA,or foreign regulatory authorities,as applicable,prior to marketing any of our products in the future.

214、Anysuch requirements could delay or prevent the sale of our products or may subject us to additional expenses.15Table of Contents We are and may become the subject of various claims,litigation or investigations which could have a material adverse effect on our business,financial condition,results of

215、 operations or price of our common stock.We are and may become subject to various claims(including“whistleblower”complaints),litigation or investigations,including commercial disputes and employeeclaims,and from time to time may be involved in governmental or regulatory investigations or similar mat

216、ters.Any claims asserted against us or our management,regardless of merit or eventual outcome,could harm our reputation and have an adverse impact on our relationship with our clients,distribution partners and otherthird parties and could lead to additional related claims.Furthermore,there is no gua

217、rantee that we will be successful in defending ourselves in pending or futurelitigation or similar matters under various laws.Any judgments or settlements in any pending litigation or future claims,litigation or investigation could have amaterial adverse effect on our business,financial condition,re

218、sults of operations and price of our common stock.Risks Related to our Intellectual Property and Cyber Security Expiration of our patents may subject us to increased competition and reduce our opportunity to generate product revenue.The patents for our products have varying expiration dates and,when

219、 these patents expire,we may be subject to increased competition and we may not be able torecover our development costs.In some of the larger economic territories,such as the United States and Europe,patent term extension/restoration may be available.We cannot,however,be certain that an extension wi

220、ll be granted or,if granted,what the applicable time or the scope of patent protection afforded during any extendedperiod will be.If we are unable to obtain patent term extension/restoration or some other exclusivity,we could be subject to increased competition and our opportunityto establish or mai

221、ntain product revenue could be substantially reduced or eliminated.Furthermore,we may not have sufficient time to recover our development costsprior to the expiration of our U.S.and non-U.S.patents.Our proprietary rights may not adequately protect our technologies and products.Our commercial success

222、 will depend on our ability to obtain patents and/or regulatory exclusivity and maintain adequate protection for our technologies and productsin the United States and other countries.We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our

223、proprietarytechnologies and products are covered by valid and enforceable patents or are effectively maintained as trade secrets.We intend to apply for additional patents covering both our technologies and products,as we deem appropriate.We may,however,fail to apply for patents onimportant technolog

224、ies or products in a timely fashion,if at all.Our existing patents and any future patents we obtain may not be sufficiently broad to prevent othersfrom practicing our technologies or from developing competing products and technologies.In addition,the patent positions of life science industry compani

225、es arehighly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.As a result,the validity and enforceability ofour patents cannot be predicted with certainty.In addition,we cannot guarantee that:we were the first to make the inventions cov

226、ered by each of our issued patents and pending patent applications;we were the first to file patent applications for these inventions;others will not independently develop similar or alternative technologies or duplicate any of our technologies;any of our pending patent applications will result in i

227、ssued patents;any of our patents will be valid or enforceable;any patents issued to us will provide us with any competitive advantages,or will not be challenged by third parties;and we will develop additional proprietary technologies that are patentable,or the patents of others will not have an adve

228、rse effect on our business.The actual protection afforded by a patent varies on a product-by-product basis,from country to country and depends on many factors,including the type of patent,thescope of its coverage,the availability of regulatory related extensions,the availability of legal remedies in

229、 a particular country and the validity and enforceability ofthe patents.Our ability to maintain and solidify our proprietary position for our products will depend on our success in obtaining effective claims and enforcing thoseclaims once granted.Our issued patents and those that may be issued in th

230、e future,or those licensed to us,may be challenged,invalidated,unenforceable orcircumvented,and the rights granted under any issued patents may not provide us with proprietary protection or competitive advantages against competitors withsimilar products.We also rely on trade secrets to protect some

231、of our technology,especially where it is believed that patent protection is inappropriate or unobtainable.However,trade secrets are difficult to maintain.While we use reasonable efforts to protect our trade secrets,our employees,consultants,contractors or scientific andother advisors may unintention

232、ally or willfully disclose our proprietary information to competitors.Enforcement of claims that a third party has illegally obtained andis using trade secrets is expensive,time consuming and uncertain.In addition,non-U.S.courts are sometimes less willing than U.S.courts to protect trade secrets.Ifo

233、ur competitors independently develop equivalent knowledge,methods and know-how,we would not be able to assert our trade secrets against them and our businesscould be harmed.16Table of Contents We may not be able to protect our intellectual property rights throughout the world.Filing,prosecuting and

234、defending patents on all our products in every jurisdiction would be prohibitively expensive.Competitors may use our technologies injurisdictions where we have not obtained patent protection to develop their own products.These products may compete with our products and may not be covered byany paten

235、t claims or other intellectual property rights.The laws of some non-U.S.countries do not protect intellectual property rights to the same extent as the laws of the United States,and many companies haveencountered significant problems in protecting and defending such rights in foreign jurisdictions.T

236、he legal systems of certain countries,particularly certaindeveloping countries,do not favor the enforcement of patents and other intellectual property protection,particularly those relating to biotechnology,which could makeit difficult for us to stop the infringement of our patents.Proceedings to en

237、force our patent rights in foreign jurisdictions could result in substantial cost and divert ourefforts and attention from other aspects of our business.If we fail to protect our intellectual property rights,our competitors may take advantage of our ideas and compete directly against us.Our success

238、will depend to a significant degree on our ability to secure and protect intellectual property rights and enforce patent and trademark protections relating toour technology.While we believe that the protection of patents and trademarks is important to our business,we also rely on a combination of co

239、pyright,trade secret,nondisclosure and confidentiality agreements,know-how and continuing technological innovation to maintain our competitive position.From time to time,litigationmay be advisable to protect our intellectual property position.However,these legal means afford only limited protection

240、and may not adequately protect our rights orpermit us to gain or keep any competitive advantage.Any litigation in this regard could be costly,and it is possible that we will not have sufficient resources to fullypursue litigation or to protect our intellectual property rights.This could result in th

241、e rejection or invalidation of our existing and future patents.Any adverse outcomein litigation relating to the validity of our patents,or any failure to pursue litigation or otherwise to protect our patent position,could materially harm our business andfinancial condition.In addition,confidentialit

242、y agreements with our employees,consultants,customers,and key vendors may not prevent the unauthorized disclosureor use of our technology.It is possible that these agreements will be breached or that they will not be enforceable in every instance,and that we will not have adequateremedies for any su

243、ch breach.Enforcement of these agreements may be costly and time consuming.Furthermore,the laws of foreign countries may not protect ourintellectual property rights to the same extent as the laws of the United States.We may incur substantial costs as a result of litigation or other proceedings relat

244、ing to patent and other intellectual property rights and we may be unable toprotect our rights to,or use of,our technology.If we choose to go to court to stop someone else from using the inventions claimed in our patents or our licensed patents,that individual or company has the right toask the cour

245、t to rule that these patents are invalid and/or should not be enforced against that third party.These lawsuits are expensive and would consume time andother resources even if we were successful in stopping the infringement of these patents.In addition,there is a risk that the court will decide that

246、these patents areinvalid or unenforceable and that we do not have the right to stop the other party from using the inventions.There is also the risk that,even if the validity orenforceability of these patents is upheld,the court will refuse to stop the other party on the grounds that such other part

247、ys activities do not infringe our rights.If we wish to use the technology claimed in issued and unexpired patents owned by others,we will need to obtain a license from the owner,enter into litigation tochallenge the validity or enforceability of the patents or incur the risk of litigation in the eve

248、nt that the owner asserts that we infringed its patents.The failure to obtaina license to technology or the failure to challenge an issued patent that we may require to discover,develop or commercialize our products may have a materialadverse effect on us.If a third party asserts that we infringed i

249、ts patents or other proprietary rights,we could face a number of risks that could seriously harm our results of operations,financial condition and competitive position,including:patent infringement and other intellectual property claims,which would be costly and time consuming to defend,whether or n

250、ot the claims have merit,and which could delay a product and divert managements attention from our business;substantial damages for past infringement,which we may have to pay if a court determines that our product or technologies infringe a competitors patentor other proprietary rights;a court prohi

251、biting us from selling or licensing our technologies unless the third party licenses its patents or other proprietary rights to us oncommercially reasonable terms,which it is not required to do;and if a license is available from a third party,we may have to pay substantial royalties or lump-sum paym

252、ents or grant cross licenses to our patents or otherproprietary rights to obtain that license.17Table of Contents The biotechnology industry has produced a proliferation of patents,and it is not always clear to industry participants,including us,which patents cover various typesof products or method

253、s of use.The coverage of patents is subject to interpretation by the courts,and the interpretation is not always uniform.If we are sued for patentinfringement,we would need to demonstrate that our products or methods of use either do not infringe the patent claims of the relevant patent,and/or that

254、the patentclaims are invalid,and/or that the patent is unenforceable,and we may not be able to do this.Proving invalidity,in particular,is difficult since it requires a showing ofclear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.U.S.patent laws as well a

255、s the laws of some foreign jurisdictions provide for provisional rights in published patent applications beginning on the date of publication,including the right to obtain reasonable royalties,if a patent subsequently issues and certain other conditions are met.Because some patent applications in th

256、e United States may be maintained in secrecy until the patents are issued,because patent applications in the United States andmany foreign jurisdictions are typically not published until 18 months after filing,and because publications in the scientific literature often lag behind actualdiscoveries,w

257、e cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications,or that wewere the first to invent the technology.Patent applications filed by third parties that cover technology similar to ours may have priority over our pa

258、tent applications and could further require us to obtainrights to issued patents covering such technologies.If another party files a U.S.patent application on an invention similar to ours,we may elect to participate in or bedrawn into an interference proceeding declared by the U.S.Patent and Tradema

259、rk Office to determine priority of invention in the United States.The costs of theseproceedings could be substantial,and it is possible that such efforts would be unsuccessful,resulting in a loss of our U.S.patent position with respect to suchinventions.Some of our competitors may be able to sustain

260、 the costs of complex patent litigation more effectively than we can because they have substantially greaterresources.In addition,any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise thefunds necessary to cont

261、inue our operations.We cannot predict whether third parties will assert these claims against us,or whether those claims will harm our business.If we are forced to defend against these claims,whether they are with or without any merit and whether they are resolved in favor of or against us,we may fac

262、e costlylitigation and diversion of managements attention and resources.As a result of these disputes,we may have to develop costly non-infringing technology,or enter intolicensing agreements.These agreements,if necessary,may be unavailable on terms acceptable to us,if at all,which could seriously h

263、arm our business or financialcondition.Our inability to protect our systems and data from continually evolving cybersecurity risks or other technological risks,including as a result of breaches of ourassociated third parties,could affect our ability to conduct our business.In conducting our business

264、,we process,transmit and store sensitive business information and personal information about our customers,vendors,and other parties.This information may include account access credentials,credit and debit card numbers,bank account numbers,social security numbers,drivers license numbers,names and ad

265、dresses and other types of sensitive business or personal information.Some of this information is also processed and stored by our third-party serviceproviders to whom we outsource certain functions and other agents,including our customers,which we refer to collectively as our associated third parti

266、es.We are a regular target of malicious third-party attempts to identify and exploit system vulnerabilities,and/or penetrate or bypass our security measures,in order togain unauthorized access to our networks and systems or those of our associated third parties.Such access could lead to the compromi

267、se of sensitive,business,personal or confidential information.As a result,we proactively employ multiple methods at different layers of our systems to defend our systems against intrusionand attack and to protect the data we collect.However,we cannot be certain that these measures will be successful

268、 and will be sufficient to counter all current andemerging technology threats that are designed to breach our systems in order to gain access to confidential information.Our computer systems and our associated third parties computer systems could be in the future,subject to breach,and our data prote

269、ction measures may not preventunauthorized access.The techniques used to obtain unauthorized access,disable or degrade service,or sabotage systems change frequently and are often difficult todetect.Threats to our systems and our associated third parties systems can derive from human error,fraud or m

270、alice on the part of employees or third parties,or mayresult from accidental technological failure.Computer viruses and other malware can be distributed and could infiltrate our systems or those of our associated thirdparties.In addition,denial of service or other attacks could be launched against u

271、s for a variety of purposes,including to interfere with our services or create adiversion for other malicious activities.Our defensive measures may not prevent downtime,unauthorized access or use of sensitive data.Further,while we select ourthird party service providers carefully,and we seek to ensu

272、re that our customers adequately protect their systems and data,we do not control their actions and are notable to oversee their processes.Any problems experienced by our associated third parties,including those resulting from breakdowns or other disruptions in theservices provided by such parties o

273、r cyber-attacks and security breaches,could adversely affect our ability to conduct our business and our financial condition.We could also be subject to liability for claims relating to misuse of personal information,such as violation of data privacy laws.We cannot provide assurance that thecontract

274、ual requirements related to security and privacy that we impose on our service providers who have access to customer data will be followed or will beadequate to prevent the unauthorized use or disclosure of data.Any failure to adequately enforce or provide these protective measures could result in l

275、iability,protracted and costly litigation,governmental intervention and fines.18Table of Contents Risks Related to our Common Stock Our stock price may be volatile,and purchasers of our securities could incur substantial losses.Our common stock,traded on the NASDAQ Capital Market,may be volatile and

276、 has experienced price and volume fluctuations.For example,in the year endedDecember 31,2020,the highest intra-day sale price of our common stock on Nasdaq was$47.22 per share and the lowest intra-day sale price of our common stock onNASDAQ was$7.37 per share.We may continue to incur substantial inc

277、reases or decreases in our stock price in the foreseeable future.Our stock price and the market prices of many publicly traded companies,including emerging companies in the life sciences industry,have been,and can be expectedto be,highly volatile.The future market price of our common stock could be

278、significantly impacted by numerous factors,including,but not limited to:Future sales of our common stock or other fundraising events;Sales of our common stock by existing shareholders;Changes in our capital structure,including stock splits or reverse stock splits;Announcements of technological innov

279、ations for new commercial products by our present or potential competitors;Developments concerning proprietary rights;Adverse results in our field or with clinical tests of our products in customer applications;Adverse litigation;Unfavorable legislation or regulatory decisions;Public concerns regard

280、ing our products;Variations in quarterly operating results;General trends in the health care industry;Global viruses,epidemics and pandemics,including the current COVID-19 pandemic;and Other factors outside of our control,including significant market fluctuations.A significant percentage of our outs

281、tanding common stock is held by two stockholders,and these stockholders therefore have significant influence on us and ourcorporate actions.As of December 31,2020,based on our review of public filings and the Companys records,two of our existing stockholders,(i)WAVI Holdings AG and(ii)CasdinCapital,

282、LLC(“Casdin”),owned,collectively,11.1 million shares of our common stock,representing 34%of the issued and outstanding shares of common stock.Accordingly,these stockholders have had,and will continue to have,significant influence in determining the outcome of any corporate transaction or other matte

283、rsubmitted to the stockholders for approval,including mergers,consolidations and the sale of all or substantially all our assets,election of directors and othersignificant corporate actions.In addition,without the consent of these stockholders,we could be prevented from entering into transactions th

284、at could be beneficial tous.Any future sales of our securities in the public markets or any future securities issuances in connection with our acquisition strategy,including with respect to theexpected merger with Global Cooling,may cause the trading price of our common stock to decline and could im

285、pair our ability to raise capital through futureequity offerings.Sales of a substantial number of shares of our common stock or other securities in the public markets,or the perception that these sales may occur,could cause themarket price of our common stock or other securities to decline and could

286、 materially impair our ability to raise capital through the sale of additional securities.If weissue additional securities in a public offering or a private placement,such sales or any resales of such securities could further adversely affect the market price of ourcommon stock.The sale of a large n

287、umber of shares of our common stock or other securities also might make it more difficult for us to sell equity or equity-relatedsecurities in the future at a time and at the prices that we deem appropriate.We do not anticipate declaring any cash dividends on our common stock.We have never declared

288、or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future.Our current policy is to retain allfunds and earnings for use in the operation and expansion of our business.19Table of Contents Risks Related to Accounting Matters Changes in accounting standards

289、 and subjective assumptions,estimates,and judgments by management related to complex accounting matters could significantlyaffect our financial results or financial condition.Generally accepted accounting principles and related accounting pronouncements,implementation guidelines,and interpretations

290、with regard to a wide range ofmatters that are relevant to our business,such as revenue recognition,asset impairment and fair value determinations,inventories,business combinations andintangible asset valuations,leases,and litigation,are highly complex and involve many subjective assumptions,estimat

291、es,and judgments.Changes in these rules ortheir interpretation or changes in underlying assumptions,estimates,or judgments could significantly change our reported or expected financial performance orfinancial condition and could require us to restate our prior financial statements and issue a non-re

292、liance statement regarding our prior financial disclosures.Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the InternalRevenue Code,and it is possible that certain transactions or a combination o

293、f certain transactions may result in material additional limitations on our ability touse our net operating loss and tax credit carryforwards.Section 382 and 383 of the Internal Revenue Code of 1986,as amended,contain rules that limit the ability of a company that undergoes an ownership change,which

294、 isgenerally any change in ownership of more than 50%of its stock over a three-year period,to utilize its net operating loss and tax credit carryforwards and certainbuilt-in losses recognized in years after the ownership change.These rules generally operate by focusing on ownership changes involving

295、 stockholders owning directlyor indirectly 5%or more of the stock of a company and any change in ownership arising from a new issuance of stock by the company.Generally,if an ownershipchange occurs,the yearly taxable income limitation on the use of net operating loss and tax credit carryforwards and

296、 certain built-in losses is equal to the product ofthe applicable long-term,tax-exempt rate and the value of the companys stock immediately before the ownership change.We may be unable to offset our taxableincome with losses,or our tax liability with credits,before such losses and credits expire and

297、 therefore would incur larger federal income tax liability.If we fail to maintain an effective system of internal controls,we may not be able to accurately report financial results or prevent fraud.If we identify a materialweakness in our internal control over financial reporting,our ability to meet

298、 our reporting obligations and the trading price of our stock could be negativelyaffected.As described in Item 9A Controls and Procedures and elsewhere in this Form 10-K,management identified a material weakness in our internal control overfinancial reporting for the fiscal years ended December 31,2

299、020 and 2019.In the course of making our assessment of the effectiveness of internal control over financial reporting as of December 31,2019,we identified a material weakness inour internal control over financial reporting with regard to our controls over the accounting for financial instruments con

300、taining characteristics of both liabilities andequity.Although substantial progress has been made in remediating this material weakness,it has not been fully remediated as of December 31,2020,and thereforethis control deficiency continues to constitute a material weakness.Specifically,due to insuffi

301、cient technical resources,the Companys controls were not operatingeffectively to allow management to timely identify errors related to the recording of certain transactions involving financial instruments as previously described.Effective internal controls are necessary to provide reliable financial

302、 reports and to assist in the effective prevention of fraud.Any inability to provide reliable financialreports or prevent fraud could harm our business.We regularly review and update our internal controls,disclosure controls and procedures,and corporate governancepolicies.In addition,we are required

303、 under the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting.Any system of internalcontrols,however well designed and operated,is based in part on certain assumptions and can provide only reasonable,not absolute,assurances that the objectives ofthe system

304、 are met.A material weakness is a deficiency,or a combination of deficiencies,in internal control over financial reporting,such that there is a reasonablepossibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.Accordi

305、ngly,a materialweakness increases the risk that the financial information we report contains material errors.While we are in the process of addressing our material weakness as disclosed herein,elements of our remediation plan can only be accomplished over time and we canoffer no assurance that these

306、 initiatives will ultimately have the intended effects.Any failure to maintain such internal controls could adversely impact our ability toreport our financial results on a timely and accurate basis.If our financial statements are not accurate,investors may not have a complete understanding of ourop

307、erations or may lose confidence in our reported financial information.Likewise,if our financial statements are not filed on a timely basis as required by the SECand The Nasdaq Stock Market,we could face severe consequences from those authorities.In either case,it could result in a material adverse e

308、ffect on our business orhave a negative effect on the trading price of our common stock.Further,if we fail to remedy this deficiency(or any other future deficiencies)or maintain theadequacy of our internal controls,we could be subject to regulatory scrutiny,civil or criminal penalties or shareholder

309、 litigation.We can give no assurance that themeasures we have taken and plan to take in the future will remediate the material weakness identified or that any additional material weaknesses or restatements of ourfinancial statements will not arise in the future due to a failure to implement and main

310、tain adequate internal control over financial reporting or circumvention of thosecontrols.Further,in the future,if we cannot conclude that we have effective internal control over our financial reporting,or if our independent registered public accounting firmis unable to provide an unqualified opinio

311、n regarding the effectiveness of our internal control over financial reporting,investors could lose confidence in the reliabilityof our financial statements,which could lead to a decline in our stock price.Failure to comply with reporting requirements could also subject us to sanctions and/orinvesti

312、gations by the SEC,The Nasdaq Stock Market or other regulatory authorities.20Table of Contents Risks Related to COVID-19 and Other Disruptive Events Our financial condition and results of operations may be adversely affected by the COVID-19 pandemic.We continue to closely monitor the impact of the C

313、OVID-19 global pandemic on all aspects of our business and geographies,including how it has and will impact ourcustomers,team members,suppliers,vendors,business partners and distribution channels.The COVID-19 global pandemic has created significant volatility,uncertainty and economic disruption,whic

314、h may continue to affect our business operations and may materially and adversely affect our results of operations,cashflows and financial position.We are currently following the recommendations of local health authorities to minimize exposure risk for our team members and visitors.While we have imp

315、lementedspecific business continuity plans to reduce the impact of COVID-19 and believe that we have sufficient inventory to meet forecasted demand for the next six to ninemonths,there is no guarantee that our continuity plan will be successful or that our inventory will meet forecasted or actual de

316、mand.Disruptions may occur for ourcustomers or suppliers that may materially affect our ability to obtain supplies or other components for our products,produce our products or deliver inventory in atimely manner.This would result in lost product revenue,additional costs,or penalties,or damage our re

317、putation.Similarly,COVID-19 could impact our customersand/or suppliers as a result of a health epidemic or other outbreak occurring in other locations which could reduce their demand for our products or their ability todeliver needed supplies for the production of our products.We cannot predict at t

318、his time the full extent to which the COVID-19 pandemic will impact our business,results,and financial condition,which will depend on manyfactors that are not known at this time,as the situation is unprecedented and continues to evolve.These include,among others,the extent of harm to public health,i

319、ncluding the duration of the pandemic,any potential subsequent waves of COVID-19 infection,the emergence of new variants of COVID-19,some of which may bemore transmissible or virulent than the initial strain,and the availability and distribution of effective vaccines and medical treatments,further d

320、isruption to themanufacturing of and demand for our products,our ability to effectively manage inventory levels and adjust our production schedules to align with demand,impairments and other charges,the impact of the global business and economic environment on liquidity and the availability of capit

321、al,the costs incurred to keep ouremployees safe while maintaining continued operations,and our ability to effectively motivate and retain the necessary workforce.We are staying in closecommunication with our manufacturing facilities,employees,customers,and suppliers,and acting to mitigate the impact

322、 of this dynamic and evolving situationthrough a variety of measures,which may not be successful and are subject to the factors described above,many of which are uncertain or outside of our control.Evenafter the COVID-19 pandemic has subsided,we may continue to experience impacts to our business as

323、a result of its global economic impact.Natural disasters,geopolitical unrest,war,terrorism,public health issues or other catastrophic events could disrupt the supply,delivery or demand of products,which could negatively affect our operations and performance.We are subject to the risk of disruption b

324、y earthquakes,floods and other natural disasters,fire,power shortages,geopolitical unrest,war,terrorist attacks and otherhostile acts,public health issues,epidemics or pandemics and other events beyond our control and the control of the third parties on which we depend.Any of thesecatastrophic event

325、s,whether in the United States or abroad,may have a strong negative impact on the global economy,our employees,facilities,partners,suppliers,distributors or customers,and could decrease demand for our products,create delays and inefficiencies in our supply chain and make it difficult or impossible f

326、or us todeliver products to our customers.A catastrophic event that results in the destruction or disruption of our data centers or our critical business or informationtechnology systems would severely affect our ability to conduct normal business operations and,as a result,our operating results wou

327、ld be adversely affected.ITEM 1B.UNRESOLVED STAFF COMMENTS None.21Table of Contents ITEM 2.PROPERTIES Our material office and manufacturing leases are detailed below:Location Square Feet Principal Use Lease ExpirationBothell,WA 32,106 Corporate headquarters,manufacturing,research and development,mar

328、keting and administrative offices July 2031Menlo Park,CA 3,460 Research and development,and administrative offices December 2021Albuquerque,NM 9,932 Manufacturing,research and development,and administrative offices December 2021Bruce Township,MI 106,998 Manufacturing,research and development,and adm

329、inistrative offices Month to MonthUnited States 12,500 Biological and pharmaceutical specimen storage January 2023United States 20,000 Biological and pharmaceutical specimen storage March 2024United States 16,153 Biological and pharmaceutical specimen storage June 2024United States 16,800 Biological

330、 and pharmaceutical specimen storage February 2026United States 26,800 Biological and pharmaceutical specimen storage November 2031 We consider the facilities to be in a condition suitable for their current uses.Because of anticipated growth in the business and due to the increasing requirements ofc

331、ustomers or regulatory agencies,we may need to acquire additional space or upgrade and enhance existing space.We believe that adequate facilities will be availableupon the conclusion of our leases.ITEM 3.LEGAL PROCEEDINGS From time to time,we may be subject to legal proceedings and claims in the ord

332、inary course of business.We are not currently aware of any such proceedings or claimsthat we believe will have,individually or in the aggregate,a material adverse effect on our business,financial condition or results of operations.ITEM 4.MINE SAFETY DISCLOSURES Not applicable.PART II ITEM 5.MARKET F

333、OR REGISTRANTS COMMON EQUITY,RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITYSECURITIES Market Information for Common Stock Our common stock is traded on the NASDAQ Capital Market exchange under the ticker symbol“BLFS.”Stockholders and Dividends As of March 19,2021,there were approximately 169 holders of record of our common stock.We have never paid cash dividends on our common stock and