Financial Data and Key Metrics Changes - The company reported revenues of $69.4 million for Q3 2019, reflecting a growth of 42% at constant currency and 28% organic growth [30][31] - Adjusted operating income increased by 34% year-over-year to $15.1 million, with adjusted EPS rising 44% to $0.26 per fully diluted share [30][42] - The company raised its full-year revenue guidance to $267 million to $270 million, indicating growth of 38% to 39% [11][46] Business Line Data and Key Metrics Changes - Direct filtration and chromatography businesses experienced organic growth of over 40% for both the quarter and year-to-date [19][31] - C Technologies contributed approximately $7 million in revenue for Q3 and is on track to meet its target of $16 million to $17 million for the partial year [14][11] - The proteins business is expected to achieve over 15% growth for the year, marking the first such growth since 2015 [20][54] Market Data and Key Metrics Changes - North America accounted for 52% of direct product revenue year-to-date, with Asia Pacific growing at 44% and Europe at 26% [31] - Gene therapy represented 13% to 15% of total revenue, with expectations for growth as the market matures [64][88] Company Strategy and Development Direction - The company is focused on integrating C Technologies and expanding manufacturing capacity for filtration and chromatography products [12][15] - New product launches, particularly the TFDF technology, are seen as significant innovations in harvest clarification [17][76] - The company aims to maintain a long-term organic growth target of 10% to 15% [74] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving strong performance in Q4 despite tough comparisons from the previous year [72] - The company is optimistic about the gene therapy market's growth potential, although it remains cautious about specific growth rates for 2020 [66][74] - The integration of C Technologies is progressing well, with a dedicated sales team being established [99][100] Other Important Information - The company generated free cash flow of $33.5 million year-to-date, with cash and cash equivalents totaling $513.5 million as of September 30, 2019 [43][42] - Adjusted gross margin for Q3 was 56.1%, with expectations for modestly lower margins in Q4 due to strategic investments [34][35] Q&A Session Summary Question: Dynamics of the protein business and lower ligands demand - Management noted strong growth in growth factors offsetting lower ligands demand, with confidence in achieving 15% organic growth for proteins [54] Question: Cross-selling opportunities with C Technologies - A dedicated sales team for C Technologies is being built to drive process analytics sales, with expectations for close collaboration with the existing sales force [56][58] Question: Overall market growth and share taking - The company has maintained a high growth rate, particularly in filtration and chromatography, with strong order demand [60][61] Question: Sustainability of gene therapy revenue - Gene therapy currently accounts for 13% to 15% of total revenue, with potential for growth as the market matures [64][66] Question: Integration progress of C Technologies - The integration is focused on building out the commercial organization, with no immediate revenue synergies expected in 2019 [100][101] Question: Capacity build-out priorities - The company is prioritizing capacity build-out for OPUS, ATF, and Spectrum businesses to meet strong demand [110][111]

[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section presents the unaudited interim financial statements and management's analysis of Repligen Corporation's financial condition and operational results [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements%20(interim%20periods%20unaudited)) Interim unaudited financial statements for Q3 and YTD 2019 show significant growth in assets, liabilities, and equity, driven by acquisitions and financing activities [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets%20as%20of%20September%2030%2C%202019%20and%20December%2031%2C%202018) The balance sheets reflect significant increases in total assets, liabilities, and stockholders' equity from December 2018 to September 2019 Consolidated Balance Sheet Summary (in thousands) | Metric | September 30, 2019 (in thousands) | December 31, 2018 (in thousands) | | :--------------------------------- | :-------------------------------- | :--------------------------------- | | Total Assets | $1,378,708 | $774,621 | | Cash and cash equivalents | $513,454 | $193,822 | | Accounts receivable, net | $41,968 | $33,015 | | Inventories, net | $51,579 | $42,263 | | Property, plant and equipment, net | $43,034 | $32,180 | | Intangible assets, net | $216,289 | $135,438 | | Goodwill | $468,845 | $326,735 | | Total Liabilities | $333,590 | $159,053 | | Total Stockholders' Equity | $1,045,118 | $615,568 | [Consolidated Statements of Comprehensive Income (Loss)](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income%20(Loss)%20for%20the%20Three%20and%20Nine%20Months%20Ended%20September%2030%2C%202019%20and%202018) Revenue increased significantly for both the three and nine months ended September 30, 2019, with mixed net income performance Comprehensive Income (Loss) Summary (in thousands) | Metric (in thousands) | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total Revenue | $69,445 | $49,529 | $200,771 | $142,090 | | Income from operations| $7,964 | $7,886 | $30,189 | $18,135 | | Net Income | $1,659 | $4,794 | $17,807 | $10,979 | | Basic EPS | $0.03 | $0.11 | $0.38 | $0.25 | | Diluted EPS | $0.03 | $0.10 | $0.37 | $0.24 | - Net income for the three months ended September 30, 2019, **decreased to $1,659k** from $4,794k in the prior year, while for the nine months ended September 30, 2019, it **increased to $17,807k** from $10,979k[12](index=12&type=chunk) [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20and%20Nine%20Months%20Ended%20September%2030%2C%202019%20and%202018) Stockholders' equity substantially increased, driven by net income, stock issuances for acquisitions, and convertible notes - Total stockholders' equity **increased significantly from $615,568k** at December 31, 2018, to **$1,045,118k** at September 30, 2019[15](index=15&type=chunk) - Key drivers include net income, issuance of common stock for debt conversion, issuance of common stock for the C Technologies acquisition, the equity component of 0.375% senior convertible notes, and proceeds from common stock issuance[15](index=15&type=chunk) Change in Stockholders' Equity (Nine Months Ended Sep 30, 2019, in thousands) | Change in Stockholders' Equity (Nine Months Ended Sep 30, 2019, in thousands) | Amount | | :---------------------------------------------------------------- | :----- | | Balance at December 31, 2018 | $615,568 | | Net income | $17,807 | | Issuance of common stock for debt conversion | $198,757 | | Issuance of common stock for C Technologies, Inc. acquisition | $53,938 | | Equity component of 0.375% senior convertible notes, net of tax | $38,088 | | Proceeds from issuance of common stock, net | $320,713 | | Balance as of September 30, 2019 | $1,045,118 | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Nine%20Months%20Ended%20September%2030%2C%202019%20and%202018) Cash flows show significant increases from financing activities, largely due to new debt and equity, while investing activities reflect acquisition outlays Cash Flow Activity (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity (Nine Months Ended Sep 30, in thousands) | 2019 | 2018 | | :------------------------------------------ | :----------- | :---------- | | Operating activities | $49,542 | $27,215 | | Investing activities | $(198,197) | $(8,580) | | Financing activities | $485,047 | $2,363 | | Effect of exchange rate changes | $(7,785) | $(4,453) | | Net increase in cash, cash equivalents and restricted cash | $328,607 | $16,545 | - Investing activities in 2019 were significantly impacted by the **$182.2 million cash outlay** for the C Technologies, Inc. acquisition[20](index=20&type=chunk) - Financing activities saw a substantial increase due to **$278.6 million from new convertible debt** and **$320.7 million from common stock issuance**, partially offset by **$115.0 million for the repayment** of senior convertible notes[20](index=20&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) These notes provide detailed context on accounting policies, fair value measurements, acquisitions, revenue, leases, and other financial statement items [Note 1. Basis of Presentation](index=9&type=section&id=1.%20Basis%20of%20Presentation) The financial statements adhere to GAAP and SEC rules, consolidating subsidiaries and adopting new lease accounting standards - The consolidated financial statements are prepared in accordance with GAAP and SEC rules for Form 10-Q, including the accounts of Repligen and its wholly-owned subsidiaries, such as C Technologies, Inc. (acquired May 31, 2019)[22](index=22&type=chunk)[24](index=24&type=chunk) - The company adopted ASU 2016-02 (ASC 842) on Leases on January 1, 2019, recognizing operating lease Right-of-Use (ROU) assets of **$17.0 million** and lease liabilities of **$21.0 million**[31](index=31&type=chunk) [Note 2. Fair Value Measurements](index=10&type=section&id=2.%20Fair%20Value%20Measurements) The company utilizes a three-level fair value hierarchy, with significant cash and convertible notes valued using Level 1 inputs - The company uses a three-level fair value hierarchy for assets and liabilities[32](index=32&type=chunk) - As of September 30, 2019, cash and cash equivalents included **$414.7 million in money market accounts**, valued using Level 1 inputs[33](index=33&type=chunk)[35](index=35&type=chunk) - The fair value of the 0.375% Convertible Senior Notes due 2024 was **$287.9 million** as of September 30, 2019, determined by a Level 1 valuation based on recent trade activity[36](index=36&type=chunk) [Note 3. Acquisition of C Technologies, Inc.](index=11&type=section&id=3.%20Acquisition%20of%20C%20Technologies%2C%20Inc.) Details the acquisition of C Technologies for $239.9 million, resulting in significant goodwill and intangible assets - Repligen acquired C Technologies, Inc. on May 31, 2019, for a total purchase price of **$239.9 million**, consisting of **$186.0 million in cash** and **779,221 unregistered shares of common stock valued at $53.9 million**[40](index=40&type=chunk)[42](index=42&type=chunk) - The acquisition resulted in an estimated **$142.9 million in goodwill** and **$90.8 million in identifiable intangible assets**, including customer relationships (**$59.7M**) and developed technology (**$28.9M**)[40](index=40&type=chunk)[43](index=43&type=chunk)[46](index=46&type=chunk) - C Technologies contributed **$7.0 million in revenue** and a **net loss of $1.2 million** for the three months ended September 30, 2019[47](index=47&type=chunk) [Note 4. Revenue Recognition](index=13&type=section&id=4.%20Revenue%20Recognition) Revenue primarily from product sales, with contributions from C Technologies and significant customers like MilliporeSigma and GE Healthcare Revenue Summary (in thousands) | Revenue (in thousands) | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :--------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Product revenue | $69,419 | $49,500 | $200,701 | $142,042 | | Royalty and other | $26 | $29 | $70 | $48 | | Total revenue | $69,445 | $49,529 | $200,771 | $142,090 | Revenue from Significant Customers (in thousands) | Revenue from Significant Customers (in thousands) | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :------------------------------------------------ | :-------------------------- | :-------------------------- | | GE Healthcare | $23,759 | $22,253 | | MilliporeSigma | $28,354 | $24,181 | - The acquisition of C Technologies added a new Process Analytics product line, including SoloVPE and FlowVPE systems, which complement existing Filtration, Chromatography, and Proteins franchises by enabling in-line protein concentration measurements[61](index=61&type=chunk) [Note 5. Leases](index=16&type=section&id=5.%20Leases) Adoption of ASC 842 led to recognition of operating lease ROU assets and liabilities, increasing due to facility expansion - Upon adopting ASC 842 on January 1, 2019, Repligen recognized operating lease ROU assets of **$17.0 million** and operating lease liabilities of **$21.0 million**[70](index=70&type=chunk) - As of September 30, 2019, these balances increased to **$24.8 million** and **$29.1 million**, respectively, partly due to new leases for facility expansion[73](index=73&type=chunk) Lease Cost (in thousands) | Lease Cost (in thousands) | 3 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2019 | | :------------------------ | :-------------------------- | :-------------------------- | | Operating lease cost | $1,207 | $3,119 | | Variable operating lease cost | $242 | $902 | | Total lease cost | $1,449 | $4,021 | [Note 6. Goodwill and Other Intangible Assets](index=18&type=section&id=6.%20Goodwill%20and%20Other%20Intangible%20Assets) Goodwill and intangible assets significantly increased due to the C Technologies acquisition, with associated amortization expense - Goodwill increased from **$326,735k** at December 31, 2018, to **$468,845k** at September 30, 2019, primarily due to the **$142,903k goodwill** recognized from the C Technologies acquisition[76](index=76&type=chunk) - Net intangible assets increased from **$135,438k** at December 31, 2018, to **$216,289k** at September 30, 2019, also driven by the C Technologies acquisition[79](index=79&type=chunk) - Amortization expense for finite-lived intangible assets was **$9.6 million** for the nine months ended September 30, 2019[80](index=80&type=chunk) [Note 7. Consolidated Balance Sheet Detail](index=20&type=section&id=7.%20Consolidated%20Balance%20Sheet%20Detail) Provides detailed breakdowns of inventories, property, plant and equipment, and accrued liabilities, including construction in progress Balance Sheet Item Detail (in thousands) | Balance Sheet Item (in thousands) | September 30, 2019 | December 31, 2018 | | :-------------------------------- | :----------------- | :---------------- | | Inventories, net | $51,579 | $42,263 | | Property, plant and equipment, net| $43,034 | $32,180 | | Accrued liabilities | $25,770 | $15,865 | - Construction in progress as of September 30, 2019, includes **$4.9 million** primarily for manufacturing expansion projects at Waltham, MA, and Rancho Dominguez, CA facilities[82](index=82&type=chunk) [Note 8. Convertible Senior Notes](index=21&type=section&id=8.%20Convertible%20Senior%20Notes) Details the issuance of new 0.375% Convertible Senior Notes due 2024 and the settlement of prior 2.125% notes - In July 2019, Repligen issued **$287.5 million** aggregate principal amount of 0.375% Convertible Senior Notes due 2024 (2019 Notes), generating net proceeds of approximately **$278.6 million**[85](index=85&type=chunk) - The company settled its outstanding 2.125% Convertible Senior Notes due 2021 (2016 Notes) during Q3 2019, resulting in a **$5.6 million loss on extinguishment of debt**[93](index=93&type=chunk)[94](index=94&type=chunk) - As of September 30, 2019, the 2019 Notes had a carrying value of **$230.2 million** and a fair value of **$287.9 million**, classified as a long-term liability[91](index=91&type=chunk)[92](index=92&type=chunk) [Note 9. Stockholders' Equity](index=23&type=section&id=9.%20Stockholders'%20Equity) Highlights public offerings of common stock, stock-based compensation expense, and shares available for future grants - Repligen completed public offerings in May and July 2019, raising approximately **$189.6 million** and **$131.1 million**, respectively, from the issuance of common stock[99](index=99&type=chunk)[100](index=100&type=chunk) Stock-Based Compensation Expense (in thousands) | Stock-Based Compensation Expense (in thousands) | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :---------------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total stock-based compensation | $3,175 | $2,779 | $9,459 | $7,672 | - As of September 30, 2019, **2,571,611 shares** were available for future grant under the 2018 Stock Option and Incentive Plan[101](index=101&type=chunk) [Note 10. Commitments and Contingencies](index=25&type=section&id=10.%20Commitments%20and%20Contingencies) Outlines facility lease expansions and strategic collaboration agreements with Sartorius Stedim Biotech and Navigo - The company expanded its Waltham, Massachusetts facility lease by approximately **32,000 square feet**, with full occupancy expected by Q3 2020[109](index=109&type=chunk) - Repligen entered a collaboration agreement with Sartorius Stedim Biotech to integrate XCell™ ATF cell retention control technology into bioreactors for continuous bioprocessing[111](index=111&type=chunk) - An agreement with Navigo for co-development of affinity ligands and a long-term supply agreement with Purolite for NGL-Impact™ A support the proteins business[112](index=112&type=chunk) [Note 11. Accumulated Other Comprehensive Loss](index=25&type=section&id=11.%20Accumulated%20Other%20Comprehensive%20Loss) Accumulated other comprehensive loss increased, primarily due to foreign currency translation adjustments - Accumulated other comprehensive loss increased from **$(11,893)k** at December 31, 2018, to **$(21,794)k** at September 30, 2019, primarily due to foreign currency translation adjustments[113](index=113&type=chunk) [Note 12. Income Taxes](index=25&type=section&id=12.%20Income%20Taxes) The effective tax rate decreased in Q3 2019 due to windfall benefits from stock option exercises and RSU vesting Effective Tax Rate | Effective Tax Rate | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :----------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Effective Tax Rate | 0.7% | 27.6% | 18.3% | 24.6% | - The lower effective tax rate in 2019 was primarily due to windfall benefits from stock option exercises and the vesting of restricted stock units[115](index=115&type=chunk) - The company adopted ASU 2016-16 in Q1 2018, which impacted deferred tax assets/liabilities and accumulated deficit[116](index=116&type=chunk) [Note 13. Earnings Per Share](index=26&type=section&id=13.%20Earnings%20Per%20Share) Basic and diluted EPS figures are presented, alongside an increase in weighted average diluted shares outstanding EPS Metric | EPS Metric | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :--------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Basic EPS | $0.03 | $0.11 | $0.38 | $0.25 | | Diluted EPS| $0.03 | $0.10 | $0.37 | $0.24 | - Weighted average diluted shares outstanding increased to **51,809k** for the three months ended September 30, 2019, from 45,828k in the prior year[126](index=126&type=chunk) [Note 14. Related Party Transactions](index=27&type=section&id=14.%20Related%20Party%20Transactions) Details rent expense incurred for facilities leased from a former owner of Spectrum LifeSciences, LLC - Repligen incurred **$0.4 million in rent expense** for the nine months ended September 30, 2019, related to facilities leased from a former owner of Spectrum LifeSciences, LLC[130](index=130&type=chunk) [Note 15. Segment Reporting](index=28&type=section&id=15.%20Segment%20Reporting) The company operates as a single segment, with revenue disaggregated by geographic region and significant customers - The company operates as one operating segment, with revenue disaggregated by geographic region and significant customers[133](index=133&type=chunk) Revenue by Geographic Location | Revenue by Geographic Location | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :----------------------------- | :-------------------------- | :-------------------------- | | North America | 51% | 47% | | Europe | 37% | 41% | | APAC | 12% | 12% | Revenue from Significant Customers (% of Total Revenue) | Revenue from Significant Customers (% of Total Revenue) | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :------------------------------------------------------ | :-------------------------- | :-------------------------- | | GE Healthcare | 12% | 16% | | MilliporeSigma | 14% | 17% | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong revenue growth from bioprocessing products and the C Technologies acquisition, alongside increased operating expenses and financing activities [Overview](index=29&type=section&id=Overview) Repligen is a leading provider of advanced bioprocessing technologies, offering solutions to enhance manufacturing efficiencies for biologic drugs - Repligen is a leading provider of advanced bioprocessing technologies and solutions, focused on increasing manufacturing efficiencies and flexibility for biologic drugs[138](index=138&type=chunk) - Key product lines include OPUS® pre-packed chromatography columns, XCell ATF™ systems, TangenX flat-sheet filters, Spectrum filtration brands (KrosFlo®, ProConnex®), Protein A ligands, and growth factors[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) [C Technologies Acquisition](index=29&type=section&id=C%20Technologies%20Acquisition) The acquisition of C Technologies, Inc. for $239.9 million enhances bioprocessing with real-time protein concentration measurement platforms - The acquisition of C Technologies, Inc. was consummated on May 31, 2019, for a total purchase price of **$239.9 million**[143](index=143&type=chunk)[146](index=146&type=chunk) - C Technologies provides SoloVPE and FlowVPE instrument platforms for measuring protein concentration using Slope Spectroscopy, enabling real-time process monitoring in bioprocessing[144](index=144&type=chunk) [Critical Accounting Policies and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company refers to its Annual Report on Form 10-K for a detailed description of its critical accounting policies and estimates - The company refers to its Annual Report on Form 10-K for the year ended December 31, 2018, for a description of its critical accounting policies and estimates[147](index=147&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Analysis of revenue, costs, operating expenses, and other income/expenses for the three and nine months ended September 30, 2019 [Revenues](index=30&type=section&id=Revenues) Product revenue experienced significant growth, driven by increased adoption of chromatography and filtration products and the C Technologies acquisition Revenue Summary (in thousands) | Revenue (in thousands) | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | % Change | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | % Change | | :--------------------- | :-------------------------- | :-------------------------- | :------- | :-------------------------- | :-------------------------- | :------- | | Products | $69,419 | $49,500 | 40.2% | $200,701 | $142,042 | 41.3% | | Total revenue | $69,445 | $49,529 | 40.2% | $200,771 | $142,090 | 41.3% | - Product revenue growth was driven by increased adoption of chromatography and filtration products and contributions from C Technologies (**$7.0 million for Q3 2019** and **$9.1 million for YTD 2019**)[152](index=152&type=chunk) - Direct sales accounted for approximately **80% of product revenue in Q3 2019** and **75% for YTD 2019**, with an expectation for this trend to continue[150](index=150&type=chunk) [Costs and operating expenses](index=31&type=section&id=Costs%20and%20operating%20expenses) Cost of product revenue, R&D, and SG&A all increased, influenced by the C Technologies acquisition and operational expansion Costs and Operating Expenses (in thousands) | Expense (in thousands) | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | % Change | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | % Change | | :--------------------- | :-------------------------- | :-------------------------- | :------- | :-------------------------- | :-------------------------- | :------- | | Cost of product revenue| $31,425 | $22,183 | 41.7% | $88,978 | $62,939 | 41.4% | | Research and development| $5,427 | $3,601 | 50.7% | $14,278 | $12,669 | 12.7% | | Selling, general and administrative | $24,629 | $15,859 | 55.3% | $67,326 | $48,347 | 39.3% | | Total costs and operating expenses | $61,481 | $41,643 | 47.6% | $170,582 | $123,955 | 37.6% | - Gross margins were **54.7% for Q3 2019** and **55.7% for YTD 2019**, or **55.2% and 56.4% respectively**, excluding **$0.3 million (Q3)** and **$1.5 million (YTD)** of inventory step-up amortization from the C Technologies acquisition[157](index=157&type=chunk) - SG&A costs increased due to the C Technologies acquisition (**$4.7 million for Q3** and **$6.2 million for YTD**), expansion of customer-facing activities, administrative infrastructure buildout, and **$4.0 million in acquisition-related transaction fees (YTD)**[162](index=162&type=chunk)[163](index=163&type=chunk) [Other expenses, net](index=32&type=section&id=Other%20expenses%2C%20net) Investment income increased, but a significant loss on debt extinguishment and higher interest expense led to increased net other expenses Other Expenses, Net (in thousands) | Other Expenses, Net (in thousands) | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | % Change | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | % Change | | :--------------------------------- | :-------------------------- | :-------------------------- | :------- | :-------------------------- | :-------------------------- | :------- | | Investment income | $1,898 | $558 | 240.1% | $3,616 | $1,251 | 189.0% | | Loss on extinguishment of debt | $(5,650) | — | 100.0% | $(5,650) | — | 100.0% | | Interest expense | $(2,857) | $(1,687) | 69.4% | $(6,326) | $(5,008) | 26.3% | | Total other expense, net | $(6,293) | $(1,263) | 398.3% | $(8,383) | $(3,570) | 134.8% | - Investment income increased due to higher average invested cash balances and interest rates[165](index=165&type=chunk) - A **$5.6 million loss on extinguishment of debt** resulted from settling the 2016 Convertible Senior Notes[166](index=166&type=chunk) - Interest expense rose due to the issuance of the 2019 Convertible Senior Notes and related amortization, partially offset by the settlement of the 2016 Notes[167](index=167&type=chunk)[168](index=168&type=chunk) [Income tax provision](index=33&type=section&id=Income%20tax%20provision) The income tax provision and effective tax rate were significantly lower in Q3 2019 due to windfall benefits from stock-based compensation Income Tax Metric | Income Tax Metric | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | % Change | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | % Change | | :---------------- | :-------------------------- | :-------------------------- | :------- | :-------------------------- | :-------------------------- | :------- | | Income tax provision | $12 | $1,829 | (99.3%) | $3,999 | $3,586 | 11.5% | | Effective tax rate| 0.7% | 27.6% | | 18.3% | 24.6% | | - The effective tax rate for Q3 2019 was significantly lower (**0.7%**) compared to Q3 2018 (**27.6%**), primarily due to windfall benefits from stock option exercises and RSU vesting[171](index=171&type=chunk) [Non-GAAP Financial Measures](index=33&type=section&id=Non-GAAP%20Financial%20Measures) Presents adjusted income from operations, net income, and EBITDA, excluding specific non-recurring and non-cash items for operational clarity Non-GAAP Metric (in thousands) | Non-GAAP Metric (in thousands) | 3 Months Ended Sep 30, 2019 | 3 Months Ended Sep 30, 2018 | 9 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2018 | | :----------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Adjusted income from operations| $15,131 | $11,299 | $50,807 | $28,354 | | Adjusted net income | $13,326 | $8,215 | $41,697 | $21,187 | | Adjusted EBITDA | $17,285 | $12,438 | $56,514 | $32,412 | - Non-GAAP measures exclude acquisition and integration costs, intangible amortization, inventory step-up charges, loss on extinguishment of debt, non-cash interest expense, and their tax effects to provide a more accurate comparison of ongoing operational performance[173](index=173&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and working capital significantly increased, providing adequate liquidity for at least the next 24 months, excluding potential acquisitions - Non-restricted cash and cash equivalents increased to **$513.5 million** at September 30, 2019, from **$193.8 million** at December 31, 2018[179](index=179&type=chunk) - Working capital increased by approximately **$436.9 million** to **$582.8 million** at September 30, 2019, from **$145.9 million** at December 31, 2018[191](index=191&type=chunk) - The company believes current cash balances are adequate for at least the next 24 months, absent acquisitions, and expects increased operating expenses for new product development and commercial capabilities[192](index=192&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=37&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) Highlights various risks and uncertainties associated with forward-looking statements, including collaborations, acquisitions, and market acceptance - The report contains forward-looking statements subject to various risks and uncertainties, including the success of collaborations, ability to grow the bioprocessing business (including acquisitions), regulatory approvals, intellectual property, manufacturing capabilities, market acceptance, competition, and ability to raise additional capital[197](index=197&type=chunk)[198](index=198&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company assesses market risks, primarily interest rate and foreign exchange, with no direct interest rate exposure and unhedged foreign currency exposures [Interest Rate Risk](index=38&type=section&id=Interest%20Rate%20Risk) The company has no direct interest rate exposure due to the absence of investments in interest-sensitive securities - As of September 30, 2019, the company held no investments in commercial paper, U.S. Government/agency securities, or corporate bonds, resulting in no direct interest rate exposure[199](index=199&type=chunk) - A hypothetical **100 basis point increase** in interest rates would have no effect on the company's cash position[199](index=199&type=chunk) [Foreign Exchange Risk](index=38&type=section&id=Foreign%20Exchange%20Risk) Primary foreign currency exposures include the Swedish kronor, Euro, and British pound, which are currently unhedged - The company's primary foreign currency exposures are the Swedish kronor, Euro, and British pound[201](index=201&type=chunk) - Fluctuations in exchange rates may adversely affect results of operations, financial position, and cash flows, but the company does not currently hedge this exposure[201](index=201&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were effective, with internal control assessment excluding C Technologies and new ERP system implementation modifying controls [Disclosure Controls and Procedures](index=38&type=section&id=Disclosure%20Controls%20and%20Procedures) Management affirmed the effectiveness of the company's disclosure controls and procedures as of September 30, 2019 - Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2019[202](index=202&type=chunk) [Changes in Internal Control](index=39&type=section&id=Changes%20in%20Internal%20Control) Internal control assessment excluded C Technologies, and a new ERP system implementation led to control modifications - The assessment of internal control over financial reporting excluded the C Technologies business, acquired on May 31, 2019, in accordance with SEC guidance for newly acquired businesses[204](index=204&type=chunk) - The company initiated the phased implementation of a new ERP system, which resulted in modifications to existing internal controls and implementation of new controls over financial reporting as of September 30, 2019[205](index=205&type=chunk) [PART II—OTHER INFORMATION](index=40&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, and other miscellaneous information [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently aware of any legal proceedings or claims that are expected to have a material adverse effect on its business, financial condition, or results of operations - The company is not currently aware of any material adverse legal proceedings or claims[208](index=208&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) There are no material changes to the risk factors previously described in the company's Quarterly Report on Form 10-Q for the period ended March 31, 2019 - No material changes to the risk factors described in the Quarterly Report on Form 10-Q for the period ended March 31, 2019[209](index=209&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported unregistered sales of equity securities related to the acquisition of C Technologies and the exchange and redemption of its 2016 Convertible Senior Notes [C Technologies Acquisition](index=40&type=section&id=C%20Technologies%20Acquisition%20(Item%202)) Unregistered shares were issued as part of the C Technologies acquisition consideration, relying on Rule 506(b) of Regulation D - On May 31, 2019, the company issued **779,221 unregistered shares of common stock**, valued at **$53.9 million**, as part of the consideration for the C Technologies acquisition, in reliance upon Rule 506(b) of Regulation D[210](index=210&type=chunk) [Exchange and Redemption of 2016 Notes](index=40&type=section&id=Exchange%20and%20Redemption%20of%202016%20Notes) The company exchanged and settled its 2016 Convertible Senior Notes for cash and common stock in private transactions - The company exchanged **$92.0 million** aggregate principal amount of its 2016 Convertible Senior Notes for cash and **1,850,155 shares of common stock** in private placement transactions[211](index=211&type=chunk)[213](index=213&type=chunk) - The remaining 2016 Notes were settled for **$23.0 million in cash** and **466,045 shares of common stock**[213](index=213&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[214](index=214&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[215](index=215&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No other information to report - None[216](index=216&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including organizational documents, indentures for convertible notes, and certifications - Key exhibits include the Restated Certificate of Incorporation, Second Amended and Restated Bylaws, Base Indenture and First Supplemental Indenture for the 0.375% Convertible Senior Notes due 2024, and Rule 13a-14(a)/15d-14(a) Certifications[218](index=218&type=chunk) [Signatures](index=42&type=section&id=Signatures) The report was officially signed by the President and CEO, and the Chief Financial Officer on October 31, 2019 - The report was signed by Tony J. Hunt, President and Chief Executive Officer, and Jon Snodgres, Chief Financial Officer, on October 31, 2019[222](index=222&type=chunk)

Repligen Corporation (NASDAQ:RGEN) Q2 2019 Results Conference Call August 1, 2019 8:30 AM ET Company Participants Sondra Newman - Global Head of Investor Relations Tony Hunt - President and Chief Executive Officer Jon Snodgres - Chief Financial Officer Conference Call Participants Tycho Peterson - JPMorgan John Kreger - William Blair Matt Hewitt - Craig-Hallum Brandon Couillard - Jefferies Paul Knight - Janney, Montgomery, Scott Steve Schwartz - First Analysis Edward White - HC Wainwright Operator Good day ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 000-14656 REPLIGEN CORPORATION (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organizat ...

Repligen Corporation Investor Presentation P REPLIGEN May 21, 2019 2 Safe Harbor This presentation contains forward looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are subject to risks and uncertainties which may cause our plans to change or actual results to differ materially from those anticipated. In particular, unforeseen events outside o ...

Financial Data and Key Metrics Changes - The company reported record revenues of $60.6 million for Q1 2019, reflecting a 37% year-over-year organic growth, despite a 1.5% headwind from foreign exchange [30][31] - Adjusted operating income increased by 68% year-over-year to $15.6 million, with adjusted operating margins improving by 500 basis points to 25.7% [31][37] - Adjusted EPS rose by 66% year-over-year to $0.28 per fully diluted share [38] Business Line Data and Key Metrics Changes - The filtration business saw a record quarter with ATF product line sales up over 50% year-over-year, and single-use XCell ATF sales increased over 100% year-on-year [12][13] - Chromatography, particularly the OPUS pre-pack column business, delivered over 40% growth year-on-year, driven by demand for larger diameter columns [15] - The proteins business grew over 25% organically, with strong demand for growth factors and ligands [16][37] Market Data and Key Metrics Changes - Direct product revenue growth was strong across regions: Asia up 72%, North America up 42%, and Europe up 23% [32] - North America accounted for 54% of direct product revenue, Europe 28%, and Asia 18% [32] Company Strategy and Development Direction - The acquisition of C Technologies is expected to add a new franchise in process analytics, enhancing the product portfolio and expanding the addressable market [9][10] - The company is focused on commercial execution, M&A, strategic partnerships, and high-impact product launches from R&D [10][11] - Plans include launching new TFF and ATF controller products in the second half of the year and increasing operational capacity to meet demand [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the performance for the year, raising revenue and adjusted EPS guidance by $16.5 million and $0.035 respectively [8][41] - The company anticipates that the first half of the year will be stronger than the second half in terms of revenue and organic growth percentage [33] - Management expects continued strong demand for growth factors and a healthy pipeline of opportunities in Asia [53][54] Other Important Information - The company raised its full-year revenue guidance to $235 million to $241 million, reflecting growth of 21% to 24% [41] - Adjusted net income guidance was increased to a range of $41 million to $44 million, with adjusted EBITDA also raised to $60 million to $63 million [44] Q&A Session Summary Question: What drove the strong growth in the growth factor business? - Management indicated that increased usage in clinical pipelines and strong partnerships contributed to the growth, with a current market share of approximately 15% to 20% [50][53] Question: What is the underlying market growth in Asia? - Management noted that the strong performance in Asia is due to the technology standard of their products and a healthy pipeline of opportunities [54] Question: What is the outlook for gross margins? - Management expects gross margins to remain in the range of 56% to 57%, with potential for annual expansion of 20 to 40 basis points [56][57] Question: What is the status of revenue synergy capture from Spectrum? - Management reported $2.5 million of revenue synergies captured in Q1, on track to meet the target of $5 million to $7 million for 2019 [63] Question: Are there any production constraints? - Management confirmed that they are meeting customer demands but are focused on increasing production capacity, particularly in the large-scale OPUS business [90]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 000-14656 REPLIGEN CORPORATION (Exact Name of Registrant as Specified in its Charter) Delaware 04-2729386 (State or Other Jur ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 Commission File Number 000-14656 REPLIGEN CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 41 Seyon Street, Bldg. 1, Suite 100 Waltham, MA 02453 (Address of principal executive offices) (Zip Code) OR ...

Financial Data and Key Metrics Changes - The company reported a record quarter with revenues of $51.9 million for Q4 2018 and $194 million for the full year 2018, reflecting organic revenue growth of 25% in Q4 and 17% for the year [28][29] - Adjusted operating income increased by 31% year-over-year in Q4, and by 25% for the full year [29][39] - Adjusted net income for Q4 was $9.8 million, a 12% increase compared to the same period in 2017, while full year adjusted net income was $33.3 million, a 23% increase [39][40] Business Line Data and Key Metrics Changes - Filtration and chromatography product lines grew over 30% organically in Q4, with the ATF product line up over 60% year-over-year [17][20] - The Spectrum portfolio had a good quarter, up 14% to 15%, with full year sales up 24% on a pro forma basis [19] - The OEM proteins business was flat for the full year, with expectations for a decline of 5% in 2019 due to GE transitioning to in-house manufacturing [23][44] Market Data and Key Metrics Changes - Direct revenue growth in Q4 was strongest in Asia and North America, up over 47% and 38% respectively [32] - For the full year, direct products in Asia, Europe, and North America accounted for approximately 16%, 29%, and 55% of sales respectively [32] - The company expects its direct to customer filtration and chromatography businesses to grow at 20% to 25% in 2019 [44] Company Strategy and Development Direction - The company aims to build out a systems team focused on TFF solutions and to win market share in perfusion and clarification applications [24] - Continued investment in R&D is planned to develop disruptive technologies across three franchises [24] - The company is actively evaluating M&A opportunities to supplement organic growth [70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to gain market share as the industry pivots towards flexible solutions and continuous processing [11] - The company anticipates a strong start to 2019, supported by a robust order demand and the opening of the Marlborough facility [18][19] - Management expects the first half of 2019 to be stronger than the second half, particularly for the proteins business [90] Other Important Information - The company increased its R&D spend to 8% of revenue in 2018, reflecting a commitment to innovation [15] - Adjusted gross margin for Q4 was 55.9%, down from 57.1% in the same period in 2017, while full year adjusted gross margin improved to 56.1% [33][34] - The company expects 2019 adjusted gross margin to be in the range of 56% to 57% [45] Q&A Session Summary Question: Can you break down the moving pieces between the GE transition in-house versus the growth factor in the protein business? - Management expects a strong first half for proteins, with ligands expected to decline while growth factors show reasonable growth. GE's transition will impact future volumes [51][52] Question: What revenue expectations do you have for TangenX and TFF this year? - The filtration portfolio is expected to see strong demand, with new products stimulating growth [54] Question: Can you provide an update on current capacity utilization and future investments? - The company has been diligent in capacity investments, with the Marlborough facility adding significant capacity. Future investments will focus on manpower rather than space [56][57] Question: What are the expectations for gene therapy in 2019 and 2020? - Management is enthusiastic about gene therapy, seeing demand for various products in this area [66] Question: What are the synergies expected from the Spectrum acquisition in 2019? - The target for 2019 is $5 million to $7 million in synergies, with a focus on cross-selling and geographic expansion [68][69] Question: How is the field service and applications team expected to impact revenue? - The field service team is growing rapidly, providing essential support and potentially impacting top-line growth [74] Question: What is the outlook for the OPUS product line? - The OPUS product line is expected to expand into larger commercial processes, benefiting from recent integrations and new product offerings [77] Question: How is the company addressing the growth of perfusion in the market? - Perfusion is growing, now accounting for about 25% of the market, with increasing applications in fed-batch processes [84] Question: What is the long-term outlook for the protein business? - The protein business is expected to remain flat to down 5% in 2019, with potential for recovery depending on new product introductions [92]