October 31, 2023 This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management's understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accuracy and completeness of such information cannot be assured. ...

[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited financial statements detail its financial position, performance, and cash flows as of Q3 2023 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets grew to $777.8 million, driven by increased cash, while stockholders' equity rose to $481.3 million Balance Sheet Highlights (In thousands) | Balance Sheet Highlights (In thousands) | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $324,603 | $243,784 | | Total current assets | $462,998 | $400,285 | | Total Assets | $777,766 | $673,870 | | **Liabilities & Equity** | | | | Total current liabilities | $112,408 | $78,884 | | Long-term debt, net | $182,131 | $189,647 | | Total Liabilities | $296,434 | $271,032 | | Total Stockholders' Equity | $481,332 | $402,838 | [Condensed Consolidated Statements of Operations and Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income) Q3 2023 net product revenues grew 36.7% YoY to $160.3 million, resulting in a net income of $38.5 million Income Statement Highlights (In thousands, except EPS) | Income Statement Highlights (In thousands, except EPS) | Q3 2023 | Q3 2022 | YoY Change | | :--- | :--- | :--- | :--- | | Net product revenues | $160,268 | $117,206 | +36.7% | | Gross profit | $127,972 | $94,247 | +35.8% | | Operating income | $64,509 | $11,901 | +442.0% | | Net income | $38,461 | $87,943 | -56.3% | | Diluted EPS | $0.63 | $1.44 | -56.3% | - The significant decrease in Q3 2023 net income compared to Q3 2022 is primarily due to a **one-time income tax benefit of $79.98 million in Q3 2022** related to the release of a valuation allowance on deferred tax assets[10](index=10&type=chunk)[139](index=139&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash from operations increased 21% to $142.7 million, offset by cash used for financing and investing activities Cash Flow Summary (In thousands) | Cash Flow Summary (In thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $142,722 | $117,788 | | Net cash used in investing activities | ($10,374) | ($94,937) | | Net cash (used in) provided by financing activities | ($52,029) | $4,183 | | **Net increase in cash** | **$80,319** | **$27,034** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key events include a $200 million debt refinancing, a $125 million share repurchase program, and the Zynerba acquisition - In July and September 2023, the company entered into a new five-year senior secured term loan facility for an aggregate principal amount of **$200 million**[53](index=53&type=chunk)[54](index=54&type=chunk) - The company extinguished its Blackstone Credit Agreement, resulting in a **loss on debt extinguishment of $9.8 million** for the third quarter of 2023[60](index=60&type=chunk)[137](index=137&type=chunk) - On August 1, 2023, the Board approved a **$125 million share repurchase program**, and during Q3 2023, the company repurchased 1.44 million shares for **$50.0 million**[70](index=70&type=chunk) - Subsequent to the quarter end, on October 10, 2023, the company completed the acquisition of Zynerba Pharmaceuticals for an aggregate consideration of **$60 million** plus contingent value rights (CVRs)[91](index=91&type=chunk)[92](index=92&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes strong Q3 revenue growth, clinical pipeline progress, the Zynerba acquisition, and capital allocation [Company Overview and Pipeline Development](index=33&type=section&id=Company%20Overview%20and%20Pipeline%20Development) The company advances its pipeline for rare neurological diseases through new indications for WAKIX and strategic acquisitions - The company's **Phase 3 INTUNE study** of pitolisant in adult patients with Idiopathic Hypersomnia (IH) **did not meet its primary endpoint**, but showed favorable trends[104](index=104&type=chunk) - Harmony received FDA alignment on the protocol for its **Phase 3 TEMPO study** in patients with Prader-Willi Syndrome (PWS) and expects to initiate the study in **Q1 2024**[104](index=104&type=chunk) - Topline results from the Phase 2 proof-of-concept trial of pitolisant in adult patients with Myotonic Dystrophy (DM1) are expected in **Q4 2023**[104](index=104&type=chunk) - On October 10, 2023, the company completed the acquisition of Zynerba Pharmaceuticals, adding **Zygel**, a pivotal Phase 3 candidate for Fragile X Syndrome, to its pipeline[108](index=108&type=chunk) [Commercial Performance](index=35&type=section&id=Commercial%20Performance) WAKIX commercial growth continues with an average of 5,800 patients and broad market access covering over 80% of insured lives - The average number of patients on WAKIX was approximately **5,800** for the three months ended September 30, 2023[112](index=112&type=chunk) - As of September 30, 2023, the company has secured formulary access for WAKIX for **more than 80% of all insured lives** (Commercial, Medicare, and Medicaid) in the U.S[112](index=112&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) Q3 revenue grew 36.7% from higher volume and pricing, while R&D expenses decreased due to a prior-year licensing fee Operating Results Comparison (In thousands) | Operating Results Comparison (In thousands) | Q3 2023 | Q3 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Net product revenues | $160,268 | $117,206 | +36.7% | | Cost of product sales | $32,296 | $22,959 | +40.7% | | Research and development | $17,499 | $40,548 | -56.8% | | Sales and marketing | $23,418 | $20,467 | +14.4% | | General and administrative | $22,546 | $21,331 | +5.7% | | Operating income | $64,509 | $11,901 | +442.0% | - The increase in net product revenues for Q3 2023 was primarily due to a **28.2% increase in the number of units shipped** and the net impact of a **7.0% price increase** that occurred in January 2023[131](index=131&type=chunk)[132](index=132&type=chunk) - The decrease in R&D expenses for Q3 2023 was primarily driven by a **$30 million licensing fee incurred in Q3 2022**, partially offset by increased clinical development work[134](index=134&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity at $438.6 million while executing debt refinancing and $50 million in share repurchases - The company held **$438.6 million in cash, cash equivalents, restricted cash, and investments** as of September 30, 2023[140](index=140&type=chunk) - In Q3 2023, the company entered into a new five-year TLA Credit Agreement for **$200 million** and used the proceeds to extinguish the previous Blackstone Credit Agreement[145](index=145&type=chunk)[146](index=146&type=chunk)[150](index=150&type=chunk) - During Q3 2023, the company repurchased **1,439,792 shares** of common stock for an aggregate cost of **$50.0 million**[151](index=151&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure from its investment portfolio and variable-rate debt - The company's primary market risk exposure is to interest rate fluctuations affecting its investment portfolio and its **$200.0 million in variable-rate debt** tied to Term SOFR[170](index=170&type=chunk)[171](index=171&type=chunk) - Management concluded that an immediate **10% change in market interest rates would not materially impact** the fair value of its investment portfolio or its debt-related obligations[170](index=170&type=chunk)[173](index=173&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective 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 the end of the period[176](index=176&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[177](index=177&type=chunk) [Part II. Other Information](index=53&type=section&id=Part%20II.%20Other%20Information) [Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings that would adversely affect its business - As of the filing date, management believes there are **no pending claims or actions** against the company that could have a material adverse effect on its business[180](index=180&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) This report references previously disclosed risk factors from the 2022 Form 10-K with no material updates - The company directs investors to review the risk factors detailed in its **2022 Form 10-K**, stating they could materially affect the business[181](index=181&type=chunk) [Issuer Purchases of Equity Securities](index=55&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company repurchased 1.44 million shares for $50 million in Q3 2023, with $75 million remaining under the program Share Repurchase Activity (Q3 2023) | Share Repurchase Activity (Q3 2023) | Total Shares Purchased | Weighted Avg. Price Paid | Approx. Value of Shares Purchased ($ thousands) | | :--- | :--- | :--- | :--- | | August 2023 | 764,800 | $32.81 | $25,093 | | September 2023 | 674,992 | $36.90 | $24,907 | | **Total** | **1,439,792** | **$34.73** | **$50,000** | - On August 1, 2023, the Board of Directors approved a share repurchase program for up to **$125.0 million**[185](index=185&type=chunk) - As of September 30, 2023, approximately **$75.0 million remained available** for repurchase under the program[183](index=183&type=chunk)

Q2 2023 Financial and Business Update This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.'s (the "Company") future financial position, business strategy and plans and objectives of management for future operations, should be considered forward-looking statements. Forward-looking ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q2 2023 Earnings Conference Call August 1, 2023 8:30 AM ET Company Participants Luis Sanay - Head, Investor Relations Dr. Jeffrey Dayno - President and CEO Jeffrey Dierks - Chief Commercial Officer Dr. Kumar Budur - Chief Medical Officer Sandip Kapadia - Chief Financial Officer Conference Call Participants Alex Sklar - Raymond James David Amsellem - Piper Sandler Francois Brisebois - Oppenheimer Graig Suvannavejh - Mizuho Securities Jason Gerberry - Bank of A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Table of Contents ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 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: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or othe ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q1 2023 Earnings Conference Call May 2, 2023 8:30 AM ET Company Participants Luis Sanay - Head, IR Jeffrey Dayno - President and CEO Jeffrey Dierks - CCO Sandip Kapadia - CFO Conference Call Participants Charles Duncan - Cantor Fitzgerald Francois Brisebois - Oppenheimer David Amsellem - Piper Sandler Graig Suvannavejh - Mizuho Securities Ami Fadia - Needham Corinne Jenkins - Goldman Sachs Jason Gerberry - Bank of America Danielle Brill - Raymond James Operat ...

Our Corporate Growth Strategy Acquire New Assets WAKIX® Net Revenue Performance U.S. Covered Lives With Formulary Access >80% Average # of Patients on WAKIX ~5,100 Continued Growth in Depth & Breadth of Prescriber Base ~85% In-Person Access to HCPs 1. Includes New Drug Applications and supplemental New Drug Applications. 2. Trial conducted by Bioprojet and Bioprojetsubmitted regulatory package to EMA. Bioprojet received EMA approval on March 15, 2023. | --- | --- | --- | --- | --- | --- | --- | --- | |----- ...

Part I. Financial Information [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company's financial statements for the quarter ended March 31, 2023, show total assets of $715.1 million, a significant increase in net income to $29.5 million from $21.5 million year-over-year, and positive cash flow from operations of $42.6 million, reflecting continued growth driven by WAKIX sales, a strong liquidity position, and detailed notes on key agreements and accounting policies [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28Unaudited%29) As of March 31, 2023, total assets were $715.1 million, an increase from $673.9 million at year-end 2022, primarily driven by an increase in cash and cash equivalents to $288.0 million, while total liabilities remained relatively stable at $272.1 million and total stockholders' equity grew to $443.0 million from $402.8 million, reflecting retained earnings from net income Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total Current Assets** | $418,087 | $400,285 | | Cash and cash equivalents | $287,962 | $243,784 | | Intangible assets, net | $154,992 | $160,953 | | **Total Assets** | **$715,092** | **$673,870** | | **Total Current Liabilities** | $85,363 | $78,884 | | Long-term debt, net | $185,063 | $189,647 | | **Total Liabilities** | **$272,051** | **$271,032** | | **Total Stockholders' Equity** | **$443,041** | **$402,838** | [Condensed Consolidated Statements of Operations and Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Unaudited%29) For the three months ended March 31, 2023, net product revenues grew **39.6%** year-over-year to $119.1 million, operating income increased to $40.4 million from $27.6 million in the prior-year period, and net income rose to $29.5 million, or $0.48 per diluted share, compared to $21.5 million, or $0.35 per diluted share, in Q1 2022, demonstrating strong profitability growth Q1 2023 vs Q1 2022 Performance (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | Change | | :--- | :--- | :--- | :--- | | Net product revenues | $119,126 | $85,313 | +39.6% | | Gross profit | $98,346 | $70,597 | +39.3% | | Operating income | $40,423 | $27,556 | +46.7% | | Net income | $29,485 | $21,485 | +37.2% | | Diluted EPS | $0.48 | $0.35 | +37.1% | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28Unaudited%29) For the first quarter of 2023, the company generated **$42.6 million** in cash from operating activities, a significant increase from $28.9 million in the prior-year period, driven by higher net income, while cash used in investing activities was $1.8 million, a sharp decrease from $40.0 million in Q1 2022, which included a large milestone payment, and cash provided by financing activities was $3.4 million, primarily from the exercise of stock options Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $42,559 | $28,852 | | Net cash used in investing activities | $(1,790) | $(40,045) | | Net cash provided by financing activities | $3,409 | $1,383 | | **Net Increase (Decrease) in Cash** | **$44,178** | **$(9,810)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) The notes provide critical context to the financial statements, detailing the company's focus on rare neurological diseases, significant revenue concentration with three specialty pharmacies, terms of license agreements with Bioprojet including milestone and royalty obligations, specifics of the $200 million Blackstone credit facility, and details on stock-based compensation plans - The company's revenue is highly concentrated, with three customers (Accredo, CVS Caremark, and Pantherx) accounting for **100% of gross product revenues** in Q1 2023[28](index=28&type=chunk) - The company depends on a single source supplier for its product and active pharmaceutical ingredient, representing a concentration of risk[29](index=29&type=chunk) - Intangible assets related to WAKIX® approvals total **$215 million** in gross carrying amount, with a remaining net book value of **$155.0 million** as of March 31, 2023, and a remaining useful life of **6.5 years**[39](index=39&type=chunk)[40](index=40&type=chunk)[42](index=42&type=chunk) - The company has a senior secured term loan facility with Blackstone for an original principal of **$200 million**, with an outstanding balance of **$197.0 million** as of March 31, 2023, and an additional **$100 million** delayed draw term loan available until August 9, 2023[49](index=49&type=chunk)[52](index=52&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the strong Q1 2023 performance to the continued commercial success of WAKIX, with net revenue increasing **39.6%** year-over-year to $119.1 million, driven by a growing patient base of approximately 5,100, while the company is advancing its pipeline with a Phase 3 trial for pitolisant in Idiopathic Hypersomnia (IH) expecting topline data in Q4 2023, and ongoing development for Prader-Willi Syndrome (PWS) and Myotonic Dystrophy (DM), with operating expenses increasing due to expanded clinical development, sales and marketing activities, and higher personnel costs, maintaining a strong liquidity position with $393.2 million in cash, equivalents, and investments [Company Overview and Pipeline](index=29&type=section&id=Company%20Overview%20and%20Pipeline) Harmony is a commercial-stage pharmaceutical company focused on rare neurological diseases, with its primary product being WAKIX® (pitolisant), actively pursuing lifecycle management for pitolisant with a Phase 3 trial in Idiopathic Hypersomnia (IH) and a Phase 2 trial in Myotonic Dystrophy (DM), with topline data for both expected in Q4 2023, and advancing its program in Prader-Willi Syndrome (PWS) to a Phase 3 trial, additionally developing HBS-102, a MCHR1 antagonist, for potential treatment of PWS symptoms - The average number of patients on WAKIX for Q1 2023 was approximately **5,100**[98](index=98&type=chunk) - The company has secured formulary access for WAKIX for more than **80% of all insured lives** in the United States[98](index=98&type=chunk) - Key pipeline milestones expected in 2023 include topline data from the Phase 3 INTUNE study in Idiopathic Hypersomnia (IH) and the Phase 2 trial in Myotonic Dystrophy (DM) in **Q4 2023**[90](index=90&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Comparing Q1 2023 to Q1 2022, net product revenue rose by **$33.8 million (39.6%)** due to increased WAKIX patient numbers and price increases, while operating expenses grew by **$14.9 million**, driven by a **75.4%** increase in R&D for clinical trials (IH, PWS, DM) and HBS-102 development, a **28.4%** rise in S&M for commercialization efforts, and a **23.4%** increase in G&A from higher personnel and amortization costs - Net product revenue increased by **39.6%** in Q1 2023 compared to Q1 2022, driven by growth in the average number of patients on WAKIX from **4,300 to 5,100** and price increases[122](index=122&type=chunk) - Research and development expenses increased by **75.4%** year-over-year, primarily due to increased clinical development work for IH, PWS, and DM, and an IPR&D charge for HBS-102[124](index=124&type=chunk) - Sales and marketing expenses grew **28.4%** year-over-year due to increased patient engagement, marketing activities, and sales force expansion[125](index=125&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2023, the company had a strong liquidity position with **$393.2 million** in cash, cash equivalents, restricted cash, and investments, with its primary funding sources being WAKIX sales and a **$200 million** senior secured term loan from Blackstone, of which **$197.0 million** was outstanding, and an additional **$100 million** delayed draw term loan available until August 2023, with management believing current capital is sufficient to fund operations for the next 12 months - The company holds **$393.2 million** in cash, cash equivalents, restricted cash, and investments as of March 31, 2023[129](index=129&type=chunk) - The company has a **$200 million** Initial Term Loan and access to a **$100 million** Delayed Draw Term Loan (DDTL) until August 9, 2023, under the Blackstone Credit Agreement[135](index=135&type=chunk) - Future potential payments include up to **$155.0 million** in milestones under the 2022 LCA with Bioprojet and significant development, regulatory, and sales milestones for HBS-102[138](index=138&type=chunk)[139](index=139&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to interest rate risk through its investment portfolio and its variable-rate debt under the Blackstone Credit Agreement, which is tied to LIBOR, though as of March 31, 2023, management states that a **10%** change in interest rates would not have a material impact on its financials, and exposure to foreign currency and inflation risk is currently considered not significant - The company's primary market risk is interest rate sensitivity on its investment portfolio and its **$197.0 million** in variable-rate debt tied to LIBOR[151](index=151&type=chunk)[152](index=152&type=chunk) - The company does not believe inflation had a material effect on its business for the three months ended March 31, 2023[155](index=155&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2023, to ensure timely and accurate reporting as required by the SEC, with no material changes to the internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective as of March 31, 2023[156](index=156&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[157](index=157&type=chunk) Part II. Other Information [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any material legal claims or actions that would have a material adverse effect on its financial condition or results of operations - As of the filing date, management believes there are no pending claims or actions that could have a material adverse effect on the company[160](index=160&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section refers investors to the detailed risk factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022, with no new or materially changed risk factors presented in this quarterly report - The company directs investors to review the risk factors detailed in its most recent Annual Report on Form 10-K[161](index=161&type=chunk) [Other Information](index=45&type=section&id=Item%205.%20Other%20Information) On May 1, 2023, the company's Board of Directors appointed Dr. Kumar Budur as the new Chief Medical Officer, following the appointment of Dr. Jeffrey Dayno as President and Chief Executive Officer on April 24, 2023, with Dr. Budur previously serving as the company's SVP & Head of Clinical Development since March 2022 - Dr. Kumar Budur was appointed as the company's new Chief Medical Officer on May 1, 2023, following Dr. Jeffrey Dayno's appointment to President and CEO[165](index=165&type=chunk)

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q4 2022 Earnings Conference Call February 21, 2023 8:30 AM ET Company Participants Luis Sanay - Head-Investor Relations Jeffrey Dierks - Chief Commercial Officer Jeffrey Dayno - Interm CEO & Chief Medical Officer Sandip Kapadia - Chief Financial Officer Conference Call Participants Francois Brisebois - Oppenheimer David Amsellem - Piper Sandler Chris Howerton - Jefferies Charles Duncan - Cantor Fitzgerald Corinne Jenkins - Goldman Sachs Ami Fadia - Needham Gr ...

Forward Looking Statements Our Three-Pillar Growth Strategy February 21, 2023 This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management's understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accu ...