Start Time: 08:30 January 1, 0000 9:37 AM ET Repligen Corporation (NASDAQ:RGEN) Q4 2022 Earnings Conference Call February 22, 2023, 08:30 AM ET Company Participants Tony Hunt - President and CEO Jon Snodgres - CFO Sondra Newman - Head, IR Conference Call Participants Jacob Johnson - Stephens Dan Arias - Stifel Puneet Souda - SVB Securities Elizabeth Garcia - UBS Matt Larew - William Blair Brandon Couillard - Jefferies Matt Hewitt - Craig-Hallum Conor McNamara - RBC Capital Markets Operator Good day, ladies ...

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 REPLIGEN CORPORATION (Exact Name of Registrant as Specified in its Charter) Delaware 04-2729386 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) 41 Seyon Street, Bldg. 1, Suite 100 Waltham, MA 02453 (Address of Principal Executive Offices) (Zip Code) For the quarterly period ended September ...

Financial Data and Key Metrics Changes - Quarterly revenue reached $201 million, despite $11 million in foreign exchange headwinds and a decline in COVID-related revenue [10][27] - Revenue for the first nine months was $615 million, reflecting a 28% organic growth, accounting for a 9% decline in COVID revenue and 5 points of FX headwinds [10][27] - Adjusted net income for Q3 was $44.4 million, a slight decrease of $0.3 million compared to the same period in 2021, with adjusted EPS at $0.77 per fully diluted share [40][41] Business Line Data and Key Metrics Changes - Filtration and chromatography businesses were the main growth drivers, with filtration up 15% organically and chromatography up over 35% [19][21] - Gene therapy revenue growth exceeded 50% year-to-date, with over 20 accounts generating more than $1 million annually, a 70% increase from the previous year [11][29] - The proteins business remained flat for the quarter, with expectations of a 10% decline for the year [22] Market Data and Key Metrics Changes - Cell and gene therapy accounts represented 14% of year-to-date reported revenue, with significant growth in approvals contributing to market optimism [30][88] - Asia/rest of world growth led at 78%, while North America grew at 10% and Europe declined by 7% [35] Company Strategy and Development Direction - The company entered two strategic collaborations to enhance its analytics and proteins franchises, including a 15-year agreement with DRS Daylight Solutions [15][16] - The company is focusing on expanding its filtration systems business, particularly for gene therapy and mRNA applications [20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a transition in the industry post-COVID, with changes in order patterns and inventory levels [52][56] - The company anticipates a modest growth rate for the base business in 2023, projecting a range of 15% to 20% [61][62] Other Important Information - The company tightened its full-year revenue guidance to $795 million to $805 million, reflecting a 19% to 20% growth [43][44] - Adjusted operating income guidance was slightly lowered to a range of $231 million to $235 million [46] Q&A Session Summary Question: Impact of destocking in the bioprocessing industry - Management noted that destocking is occurring primarily in COVID accounts, with a shift in order patterns observed [52][56] Question: Guidance for base business strength in 2023 - Management indicated that while COVID-related revenue is decreasing, the base business is expected to grow modestly, aligning with historical growth rates [61][62] Question: Fungibility of product portfolio between COVID and non-COVID work - Management clarified that while there are pockets of inventory, the product lines are not strictly dedicated to COVID, allowing flexibility in usage [82] Question: Chromatography resin availability for 2023 - Management reported improvements in resin availability, with expectations for full capacity by the second half of next year [68][69] Question: Pricing environment and inflationary pressures - Management has implemented price increases to offset inflation, with expectations for net achievable price increases above 5% [105] Question: Long-term partnerships and expansion into mAb fragments - Management expressed confidence in the long-term partnership with Purolite, emphasizing the strategic importance of expanding into mAb fragments [111][112]

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the company's unaudited consolidated financial statements, management's discussion, market risk, and internal controls assessment [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Repligen's unaudited consolidated financial statements, including balance sheets, income, and cash flows, detailing financial position and performance [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2022, total assets increased to $2.44 billion, liabilities to $639.6 million, and stockholders' equity to $1.81 billion Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Total current assets** | $975,995 | $931,677 | | **Total assets** | **$2,444,916** | **$2,358,354** | | **Total current liabilities** | $423,522 | $375,262 | | **Total liabilities** | **$639,552** | **$608,287** | | **Total stockholders' equity** | **$1,805,364** | **$1,750,067** | [Consolidated Statements of Comprehensive Income](index=4&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income) For Q2 2022, revenue grew 27.4% to $207.6 million with $49.9 million net income, and six-month revenue rose 35.4% to $414.0 million Financial Performance (in thousands, except per share data) | Metric | Q2 2022 | Q2 2021 | YTD 2022 | YTD 2021 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $207,633 | $162,960 | $414,033 | $305,797 | | **Income from Operations** | $63,168 | $48,240 | $123,168 | $84,623 | | **Net Income** | $49,861 | $36,233 | $96,825 | $65,683 | | **Diluted EPS** | $0.88 | $0.64 | $1.68 | $1.16 | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities was $68.8 million for the six months ended June 30, 2022, with investing activities using $54.4 million, leading to a $7.3 million cash decrease Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | $68,834 | $46,913 | | **Net cash used in investing activities** | ($54,434) | ($26,198) | | **Net cash (used in) provided by financing activities** | ($14,314) | $852 | | **Net (decrease) increase in cash** | **($7,302)** | **$17,035** | [Notes to Unaudited Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) The notes detail accounting policies, 2021 acquisitions, revenue by geography, goodwill, intangibles, convertible notes, and stock-based compensation - Effective January 1, 2022, the company adopted ASU 2020-06, which simplified accounting for convertible debt, resulting in material adjustments of **$39.1 million** to additional paid-in capital and **$17.3 million** to retained earnings[23](index=23&type=chunk) - The company details the 2021 acquisitions of Bio-Flex/NTM and Avitide, with the Avitide acquisition including up to **$125.0 million** in contingent consideration[36](index=36&type=chunk)[49](index=49&type=chunk) - The 0.375% Convertible Senior Notes due 2024 became convertible at the option of holders during Q3 2022, as the stock price condition was met, and their carrying value is classified as a current liability[84](index=84&type=chunk) Revenue by Geography (Six Months Ended June 30) | Region | 2022 (%) | 2021 (%) | | :--- | :--- | :--- | | North America | 43 | 42 | | Europe | 39 | 39 | | APAC/Other | 18 | 19 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, highlighting revenue growth, gross margin trends, and strong liquidity with $596.5 million in cash [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Total revenue for the six months ended June 30, 2022, increased 35.4% to $414.0 million, with a slight gross margin decrease and rising operating expenses Revenue Comparison (in thousands) | Period | 2022 | 2021 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Three Months Ended June 30** | $207,633 | $162,960 | $44,673 | 27.4% | | **Six Months Ended June 30** | $414,033 | $305,797 | $108,236 | 35.4% | - Product revenue growth was driven by robust demand for filtration, chromatography, and process analytics products, continued adoption by key customers, and contributions from 2021 acquisitions[139](index=139&type=chunk) - Gross margin for the six months ended June 30, 2022, decreased to **59.3%** from **60.2%** in 2021, primarily due to increased employee-related costs, higher occupancy costs from capacity expansion, and increased depreciation expense[144](index=144&type=chunk) - R&D expenses for the six months ended June 30, 2022, increased by **41.2%** to **$22.6 million**, driven by spending on new product development and investments in newly acquired businesses[146](index=146&type=chunk) [Non-GAAP Financial Measures](index=32&type=section&id=Non-GAAP%20Financial%20Measures) The company provides non-GAAP financial measures, with adjusted income from operations at $132.9 million and adjusted EBITDA at $139.9 million for the six months ended June 30, 2022 Reconciliation of GAAP Net Income to Adjusted EBITDA (Six Months Ended June 30, in thousands) | Description | 2022 | 2021 | | :--- | :--- | :--- | | **GAAP net income** | **$96,825** | **$65,683** | | EBITDA Adjustments | $46,478 | $35,368 | | **EBITDA** | **$143,303** | **$101,051** | | Other non-GAAP adjustments | ($3,404) | $7,371 | | **Adjusted EBITDA** | **$139,899** | **$108,422** | Reconciliation of GAAP to Non-GAAP Adjusted Net Income (Six Months Ended June 30, in thousands) | Description | 2022 | 2021 | | :--- | :--- | :--- | | **GAAP net income** | **$96,825** | **$65,683** | | Non-GAAP adjustments | $8,307 | $17,947 | | **Non-GAAP adjusted net income** | **$105,132** | **$83,630** | [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2022, Repligen had $596.5 million in cash, with $68.8 million from operating activities, deemed sufficient for at least 24 months - The company ended the quarter with **$596.5 million** in cash and cash equivalents[168](index=168&type=chunk) - Cash from operating activities for the six months ended June 30, 2022, was **$68.8 million**, an increase of **$21.9 million** from the prior year, driven by higher net income[170](index=170&type=chunk)[171](index=171&type=chunk) - Investing activities used **$54.4 million**, mainly for capital expenditures to increase manufacturing capacity[173](index=173&type=chunk) - Management believes current cash balances are adequate to meet cash needs for at least the next **24 months**[177](index=177&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks, primarily interest rate and foreign exchange, with no current hedging of foreign currency exposure - The company's primary market risks are interest rate and foreign exchange risk[183](index=183&type=chunk)[185](index=185&type=chunk) - As of June 30, 2022, the company had no investments subject to interest rate risk[183](index=183&type=chunk) - The company does not currently hedge its exposure to foreign currency fluctuations, with primary exposures in the Swedish krona, Euro, and British pound[185](index=185&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal controls - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2022[186](index=186&type=chunk) - No material changes to internal control over financial reporting occurred during the three months ended June 30, 2022[187](index=187&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section details legal proceedings, risk factor updates, unregistered equity sales, and a list of filed exhibits [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings or claims that would adversely affect its business or financial condition - The company reports no material legal proceedings[189](index=189&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K have been reported - No material changes to the risk factors described in the Form 10-K for the period ended December 31, 2021, have been reported[190](index=190&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None[191](index=191&type=chunk) [Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents and required certifications - Lists exhibits filed with the report, including certifications by the CEO and CFO[196](index=196&type=chunk)

Repligen Corporation (NASDAQ:RGEN) Q2 2022 Earnings Conference Call August 2, 2022 8:30 AM ET Company Participants Sondra Newman – Head-Investor Relations Tony Hunt – President and Chief Executive Officer Jon Snodgres – Chief Financial Officer Conference Call Participants Dan Arias – Stifel Julia Qin – J.P. Morgan Jacob Johnson – Stephens Lisa Garcia – UBS Matt Larew – William Blair Paul Knight – KeyBanc Matt Hewitt – Craig-Hallum Capital Group Puneet Souda – SVB Securities Operator Good morning and welcome ...

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, 2022 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 Jurisdiction of Incorpora ...

Financial Data and Key Metrics Changes - The company reported record revenue of $206.4 million for Q1 2022, representing a 45% increase year-over-year [36][43] - Adjusted net income for Q1 2022 was $53.7 million, a 39% increase compared to Q1 2021 [51] - Adjusted EPS increased to $0.92 per fully diluted share, up 34% from $0.68 in the prior year [51] - Adjusted gross margin improved to 60.4%, up from 59.3% in the same period last year [46] Business Line Data and Key Metrics Changes - The base business grew by 37% year-over-year, with core monoclonal antibody markets and gene therapy contributing significantly [10][36] - Gene therapy revenue grew over 100% year-over-year, accounting for 14% of total revenue in Q1 2022 [27][36] - The filtration business saw over 50% growth compared to Q1 2021, driven by strong demand in mAbs, biosimilars, and gene therapy [29] - The chromatography segment is expected to grow by 25% to 30% [31] Market Data and Key Metrics Changes - Revenue from Asia/rest of the world increased by 27%, Europe grew by 63%, and North America grew by 35% in Q1 2022 [45] - COVID-related revenues were approximately $50 million, representing 26% of total revenue for the quarter [14][37] - The company expects COVID revenues for the full year 2022 to decline by about 20% compared to last year, projecting around $150 million [16][55] Company Strategy and Development Direction - The company is focused on expanding manufacturing capacity and reducing lead times, with a goal to bring new facilities online in the next few months [21][42] - Key priorities for 2022 include supporting acquisitions, developing new products, and penetrating cell and gene therapy accounts [19][20] - The company aims to achieve $1 billion in revenue by 2024, with a projected growth rate of 20% to 25% for non-COVID business [35][82] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the base business, projecting growth of 24% to 31% for 2022 [18][55] - The company anticipates that COVID demand will normalize, but expects meaningful revenues from COVID-related products for the foreseeable future [34][91] - Management highlighted the importance of new product launches and the robust bioprocessing market as key drivers for future growth [87][90] Other Important Information - The company plans to invest approximately $70 million in capital expenditures in 2022 [41][58] - Adjusted operating income for Q1 2022 was $67.4 million, reflecting a 47% increase year-over-year [49] Q&A Session Summary Question: Can you discuss the cadence for COVID revenues throughout the year? - Management indicated that approximately 65% of COVID revenues are expected in the first half of the year and 35% in the second half, with a cautious outlook for 2023 [62][63] Question: How has market share changed over the last couple of years? - Management attributed market share gains to a strong and differentiated product portfolio, successful M&A, and new product introductions [64][66] Question: What are the biggest opportunities in the gene therapy market? - The filtration portfolio is seen as a key area for growth, with expectations of significant contributions from new products and technologies [70][72] Question: How does the company plan to manage inflation and supply chain challenges? - The company is passing along price increases to customers and is seeing some improvement in resin availability, although challenges remain [98][110] Question: What is the outlook for the Asia-Pacific region? - Filtration products are performing well in Asia-Pacific, with expectations for continued growth, contingent on the reopening of markets like China [106][108]

Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION | 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 jurisdiction of (I.R.S. Employer | | incorporation or organization) Identification No.) | | 41 Seyon Street, Bldg. 1, S ...

Financial Data and Key Metrics Changes - The company reported record revenue of $186.5 million for Q4 2021, representing a 72% increase year-over-year, and $670.5 million for the full year, reflecting an 83% growth [32][35] - Adjusted net income for Q4 2021 was $46.9 million, a 64% increase compared to Q4 2020, and for the full year, it was $175.3 million, up 97% from 2020 [42] - Adjusted EPS for Q4 2021 increased to $0.81, a 56% rise from $0.52 in Q4 2020, while the full year adjusted EPS was $3.06, an 85% increase from $1.65 in 2020 [42] Business Line Data and Key Metrics Changes - The filtration franchise was the major growth driver, with over 100% growth in Q4 and over 130% for the full year [26] - Gene therapy revenues increased by 85% in Q4 and approximately 40% for the year, indicating strong market traction [20] - The chromatography business grew by 29% for the year, with OPUS revenues increasing by 22% [24] Market Data and Key Metrics Changes - Revenue from Asia-rest of world increased by 136%, Europe grew by 94%, and North America grew at 58% for the full year 2021 [37] - COVID-related revenues accounted for 33% of total revenue in Q4 and 28% for the full year, with expectations of $200 million to $220 million in COVID revenues for 2022 [21][45] Company Strategy and Development Direction - The company aims to build out capacity to support growth, integrate recent acquisitions, launch new products, and continue traction in cell and gene therapy [28] - The total addressable market (TAM) increased from $3.7 billion to over $8 billion, largely due to COVID impacts and strategic acquisitions [11][63] - The company is focused on sustainability initiatives, including a commitment to renewable energy and diversity and inclusion [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the bioprocessing market and expects to achieve revenue guidance of $800 million to $830 million for 2022, representing growth of 19% to 24% [45][70] - The order book for cell and gene therapy remains robust, with no observed slowdown, indicating a healthy pipeline [60][71] Other Important Information - The company spent approximately $71 million in capital expenditures in 2021, with 80% allocated to capacity investments [33] - Adjusted gross margin for the full year 2021 was 58.9%, a 120 basis point improvement year-over-year [38] Q&A Session Summary Question: Outlook for filtration growth - Management expects filtration growth of 25% to 35% in 2022, driven by traction in flat sheet cassettes and ATF technology [51][52] Question: Growth in cell and gene therapy - The company anticipates adding new customers at a similar pace as in 2021, with a focus on late-stage approvals to drive momentum [56][58] Question: Impact of market volatility on pipeline - Management noted that the impact is more on early-stage research, with solid order activity observed in the base business [70] Question: Inventory levels in the channel - The company acknowledged a trend of slowing inventory build, which may not significantly impact operations until the second half of the year [73] Question: Capacity expansion details - The average capacity increase across product lines is estimated to be around 4x, with significant increases in hollow fiber capacity [76][77] Question: Initial response to new resin products - The response to new AAV manufacturing resin products has been positive, with expectations for customer evaluations to lead to orders in the future [84][86]

PART I - FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Unaudited interim financial statements show significant growth in assets, revenue, and net income, with strong operational cash flow despite cash used for acquisitions [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to $2.24 billion as of September 30, 2021, driven by acquisitions, with a corresponding rise in liabilities and stockholders' equity Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | **$2,241,397** | **$1,902,887** | | Cash and cash equivalents | $621,098 | $717,292 | | Inventories, net | $156,163 | $95,025 | | Intangible assets, net | $340,163 | $287,100 | | Goodwill | $833,559 | $618,305 | | **Total Liabilities** | **$526,132** | **$373,737** | | Noncurrent contingent consideration | $79,962 | $0 | | **Total stockholders' equity** | **$1,715,265** | **$1,529,150** | [Consolidated Statements of Comprehensive Income](index=6&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income) The company reported significant year-over-year growth in revenue and profitability for both the quarter and nine-month period ended September 30, 2021 Financial Performance (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | % Change | Nine Months 2021 | Nine Months 2020 | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $178,216 | $94,060 | 89.5% | $484,013 | $257,612 | 87.9% | | Income from Operations | $45,194 | $20,961 | 115.6% | $129,817 | $52,404 | 147.7% | | Net Income | $33,498 | $14,552 | 129.9% | $99,181 | $40,228 | 146.5% | | Diluted EPS | $0.58 | $0.27 | 114.8% | $1.74 | $0.75 | 132.0% | [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity increased to $1.72 billion, primarily driven by net income and common stock issuance for the Avitide acquisition - Key drivers for the increase in stockholders' equity during the first nine months of 2021 were net income of **$99.2 million** and stock-based compensation of **$20.5 million**[15](index=15&type=chunk) - The company issued **271,096** shares of common stock valued at **$77.6 million** as part of the consideration for the acquisition of Avitide Inc[15](index=15&type=chunk) [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operations increased, but significant cash used in investing activities, primarily for acquisitions, led to an overall decrease in cash and cash equivalents Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash provided by operating activities | $69,396 | $47,754 | | Net cash used in investing activities | ($158,893) | ($43,097) | | Net cash provided by financing activities | $730 | $7,078 | | **Net (decrease) increase in cash** | **($96,194)** | **$15,895** | - Cash used for acquisitions, net of cash acquired, was **$121.0 million** in the first nine months of 2021, a significant increase from **$28.4 million** in the same period of 2020[18](index=18&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) The notes provide detailed disclosures on accounting policies, recent acquisitions, asset composition, convertible notes, and segment reporting [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes strong financial performance to robust demand and strategic acquisitions, maintaining a strong liquidity position despite significant investment outflows [Acquisitions](index=36&type=section&id=Acquisitions) Repligen completed key acquisitions of Avitide and Polymem in 2021, expanding capabilities in affinity ligand development and hollow fiber manufacturing - **Avitide, Inc. Acquisition (Sep 2021):** Acquired for its leading technology in affinity ligand discovery and development, aiming to expand Repligen's proteins franchise to address purification needs of gene therapies and other emerging modalities[133](index=133&type=chunk)[134](index=134&type=chunk) - **Polymem S.A. Acquisition (Jul 2021):** Acquired to expand the portfolio of hollow fiber systems and consumables, substantially increasing membrane and module manufacturing capacity and establishing a center of excellence in Europe[135](index=135&type=chunk)[136](index=136&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Revenue for the nine months increased by 87.9% to $484.0 million, driven by strong product demand, while operating expenses also rose significantly Revenue Breakdown (in thousands) | Period | Product Revenue | % Change YoY | Total Revenue | % Change YoY | | :--- | :--- | :--- | :--- | :--- | | **Q3 2021** | $178,177 | 89.5% | $178,216 | 89.5% | | **Nine Months 2021** | $483,834 | 87.9% | $484,013 | 87.9% | - Product revenue growth was driven by robust demand for filtration and proteins products, accelerated demand related to COVID-19 vaccines and therapeutics, and increased demand for gene therapy and monoclonal antibody manufacturing[147](index=147&type=chunk) Operating Expense Changes (Nine Months 2021 vs 2020) | Expense Category | % Change YoY | | :--- | :--- | | Cost of product revenue | 81.8% | | Research and development | 86.9% | | Selling, general and administrative | 58.3% | [Non-GAAP Financial Measures](index=41&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP financial measures are provided to offer a clearer view of operational performance by excluding specific non-recurring or non-cash items Reconciliation of GAAP to Non-GAAP Adjusted Net Income (Nine Months Ended Sep 30, 2021) | Description | Amount (in thousands) | Per Share | | :--- | :--- | :--- | | **GAAP net income** | **$99,181** | **$1.74** | | Inventory step-up charges | $1,868 | $0.03 | | Acquisition and integration costs | $11,593 | $0.20 | | Intangible amortization | $16,001 | $0.28 | | Non-cash interest expense | $8,592 | $0.15 | | Tax effect of non-GAAP charges | ($8,904) | ($0.16) | | **Non-GAAP adjusted net income** | **$128,337** | **$2.25** | Adjusted EBITDA (in thousands) | Period | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | **Adjusted EBITDA** | **$60,516** | **$29,416** | **$168,939** | **$78,032** | [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains a strong liquidity position with $621.1 million in cash, sufficient for future needs despite significant cash outflows for acquisitions - The company held **$621.1 million** in cash and cash equivalents at September 30, 2021, down from **$717.3 million** at December 31, 2020[172](index=172&type=chunk) Cash Flow Summary (Nine Months Ended Sep 30, 2021, in thousands) | Activity | Cash Flow | | :--- | :--- | | Operating activities | $69,396 | | Investing activities | ($158,893) | | Financing activities | $730 | - The company believes its current cash balances are adequate to meet cash needs for at least the next **24 months**, absent further acquisitions[187](index=187&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rates and foreign currency exchange, with no hedging currently employed for foreign currency exposure - The company has no investments in commercial paper, government securities, or corporate bonds as of September 30, 2021, thus a hypothetical **100 basis point** interest rate increase would have no effect on its cash position[195](index=195&type=chunk) - Primary foreign currency exposures include the Swedish krona, Euro, and British pound. The company does not currently use hedging instruments to manage this risk[197](index=197&type=chunk) [Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, with the assessment of internal controls excluding recently acquired businesses - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of the end of the quarter[198](index=198&type=chunk) - The scope of the assessment of internal control over financial reporting for Q3 2021 does not include the recently acquired Polymem and Avitide businesses[199](index=199&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings or claims that would adversely affect its operations or financial condition - As of the filing date, the company reports no **material** legal proceedings[201](index=201&type=chunk) [Risk Factors](index=50&type=page&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors from the annual report are reported - No **material** changes to risk factors from the Form 10-K for the period ended December 31, 2020 are reported[202](index=202&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=50&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued unregistered common stock valued at $77.6 million for the Avitide acquisition, exempt under Rule 506(b) of Regulation D - As part of the Avitide acquisition, the company issued **271,096** unregistered shares of common stock valued at **$77.6 million**[203](index=203&type=chunk) [Exhibits](index=51&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including certifications and XBRL data files [Signatures](index=52&type=page&id=Signatures) The report is duly signed by the President and CEO, and the CFO, on October 28, 2021