On February 27, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Crinetics Pharmaceuticals, FEB 27, 2025, View Source [SID1234650699]).

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"2024 was a year of significant progress and execution across all fronts," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "The acceptance of our NDA for paltusotine in acromegaly was a key achievement, and under the leadership of our new chief commercial officer, Isabel Kalofonos, our commercial team is preparing for the expected launch, which will be a truly significant milestone for the company. Our ongoing clinical programs continue to yield promising results, paving the way to initiate four late-stage trials this year. We’re also advancing four new candidates toward IND filing, underscoring the power of our internal research and development engine. Our balance sheet empowers us to execute our strategic vision over the next several years, and we are excited to bring on board a new chief financial officer, Toby Schilke, to provide financial leadership during this next stage of growth. Building on the strong foundation we’ve established, 2025 is positioned to be a transformative year for Crinetics."

Full Year 2024 and Recent Highlights:

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Strengthened leadership team with key appointments across finance, commercial, medical and clinical development to strengthen organization ahead of launch. In February 2025, Crinetics appointed Tobin "Toby" Schilke as Chief Financial Officer. In December 2024, Crinetics appointed Isabel Kalofonos as Chief Commercial Officer. In April 2024, Crinetics appointed Lise Kjems, M.D., Ph.D. as Senior Vice President of Endocrinology Clinical Research, and in October 2024, appointed Bin Zhang, M.D., M.Sc. as Senior Vice President of Oncology Clinical Development. In May 2024, Crinetics appointed Robert M. Cuddihy, M.D., as Senior Vice President of Medical Affairs.
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New Drug Application (NDA) for paltusotine for the treatment of acromegaly filed and accepted for review by U.S. Food and Drug Administration (FDA). This submission was based on positive topline results from the PATHFNDR-1 trial reported in September 2023 and from the PATHFNDR-2 trial reported in March 2024.
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European Medicines Agency (EMA) granted paltusotine Orphan Drug Designation (ODD) for the treatment of acromegaly. Designation was given following a positive recommendation from the EMA Committee for Orphan Medicinal Products, highlighting the potential impact of paltusotine for acromegaly patients in the EU.
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Phase 2 open-label study of paltusotine in carcinoid syndrome reported positive results. In March 2024, Crinetics reported positive topline results; paltusotine was shown to result in rapid and sustained reductions in frequency and severity of flushing episodes and bowel movements.

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Phase 2 TouCAHn open-label study of atumelnant in congenital adrenal hyperplasia (CAH) reported positive results. In January 2025, Crinetics reported positive topline results. Atumelnant administration was shown to result in rapid, substantial and sustained statistically significant reduction in A4 levels, the key biomarker for disease control. Atumelnant was well-tolerated and treatment with atumelnant was associated with significant clinical improvements.
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Debut of novel Nonpeptide Drug Conjugate (NDC) platform. Presented data from CRN09682 at the North American Neuroendocrine Tumor Society (NANETS) Annual Meeting in November 2024.
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Development candidates nominated in multiple programs. Crinetics has identified an oral thyroid stimulating hormone (TSH) receptor antagonist development candidate for the potential treatment of Graves’ disease, including hyperthyroidism and thyroid eye disease (TED); an oral parathyroid hormone (PTH) antagonist development candidate for the treatment of hyperparathyroidism; and an SST3 agonist development candidate for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
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Strengthened balance sheet. Current cash position of $1.4B is expected to support our business activities into 2029.

Key Upcoming Milestones:

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FDA Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025 for paltusotine NDA for the treatment and maintenance therapy of acromegaly.
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Enrollment of the first patient in the pivotal Phase 3 trial of paltusotine in carcinoid syndrome is anticipated in the second quarter of 2025.
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Crinetics expects to begin enrollment of patients in two pivotal studies of atumelnant in CAH: Phase 3 in adults and Phase 2b/3 in pediatrics.
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Crinetics is also planning a study of atumelnant in Cushing’s disease. Enrollment of patients is expected to begin in late 2025 or early 2026.
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Four novel IND filings expected in 2025 for the development candidates nominated in 2024.

Fourth Quarter and Full Year 2024 Financial Results:

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Research and development expenses were $66.6 million and $240.2 million for the three months and full year ended December 31, 2024, compared to $45.6 million and $168.5 million for the same periods in 2023. The increases were primarily attributable to an increase in personnel costs of $12.6 million for the quarter ended December 31, 2024 and $43.4 million for the year ended December 31, 2024, and increased clinical and preclinical development activities of $5.1 million and $10.2 million for the quarter and year ended December 31, 2024, respectively.
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General and administrative expenses were $28.2 million and $99.7 million for the three months and full year months ended December 31, 2024, compared to $17.1 million and $58.1 million for the same periods in 2023. The increases were primarily driven by an increase in personnel costs of $5.4 million for the quarter ended December 31, 2024 and $23.8 million for the year ended December 31, 2024.
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Net loss for the three months ended December 31, 2024, was $80.6 million, compared to a net loss of $60.1 million for the same period in 2023. For the year ended December 31, 2024, the company’s net loss was $298.4 million compared to a net loss of $214.5 million for the year ended December 31, 2023.
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There were no revenues for the three months ended December 31, 2024 or 2023. Revenues were $1.0 million for the full year ended December 31, 2024, compared to $4.0 million for the same period in 2023. Revenues for 2024 were primarily derived from the paltusotine licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. License revenues for 2023 were derived from licensing agreements with Sanwa Kagaku Kenkyusho Co., Ltd. and Cellular Longevity, Inc.
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Cash, cash equivalents, and investments totaled $1.4 billion as of December 31, 2024, compared to $558.6 million as of December 31, 2023. This includes gross proceeds of $350 million from the February 2024 private placement equity financing and $575 million from the October 2024 public offering. Based on current projections, Crinetics expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2029. For 2025, we anticipate our cash used in operations to be between $340 and $380 million.

Conference Call and Webcast Details

Management will hold a live conference call and webcast today, Thursday, February 27 at 4:30 p.m. ET. To participate, please dial 1-800-267-6316 (domestic) or 1-203-518-9783 (international) and refer to Conference ID CRNXQ4. To access the webcast, the direct link (HERE) or visit the Events section of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

On February 27, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2024 (Press release, Puma Biotechnology, FEB 27, 2025, View Source [SID1234650717]). Unless otherwise stated, all comparisons are for the fourth quarter and full year 2024 compared to the fourth quarter and full year 2023.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net for the fourth quarter of 2024 was $54.4 million, compared to $53.2 million in the fourth quarter of 2023. Product revenue, net for the full year 2024 was $195.2 million, compared to $203.1 million in 2023.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $19.3 million, or $0.39 per basic and diluted share, for the fourth quarter of 2024, compared to net income of $12.3 million, or $0.26 per basic and diluted share, for the fourth quarter of 2023. Net income for full year 2024 was $30.3 million, or $0.62 per basic and diluted share, compared to net income of $21.6 million, or $0.46 per basic share and $0.45 per diluted share, for full year 2023.

The fourth quarter 2024 net income of $19.3 million, or $0.39 per basic and diluted share includes a partial release of our valuation allowance that favorably impacted net income by $7.1 million and favorably impacted earnings per share by $0.15 per basic and diluted share. This compares to net income in the third quarter 2024 of $20.3 million, or $0.41 per basic and diluted share.

Non-GAAP adjusted net income was $21.1 million, or $0.43 per basic and diluted share, for the fourth quarter of 2024, compared to non-GAAP adjusted net income of $14.8 million, or $0.31 per basic and diluted share, for the fourth quarter of 2023. Non-GAAP adjusted net income for full year 2024 was $38.5 million, or $0.79 per basic and $0.78 per diluted share, compared to non-GAAP adjusted net income of $31.8 million, or $0.68 per basic share and $0.67 per diluted share, for full year 2023. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the fourth quarter of 2024 was $15.6 million, compared to net cash provided by operating activities of $10.5 million for the fourth quarter of 2023. Net cash provided by operating activities for full year 2024 was $38.9 million, compared to net cash provided by operating activities of $27.0 million for full year 2023. At December 31, 2024, Puma had cash, cash equivalents, and marketable securities of approximately $101 million, compared to cash, cash equivalents, and marketable securities of $96 million at December 31, 2023.

"We are very pleased with our financial results for the fourth quarter of 2024, as well as for the full year 2024, and we are very pleased to be able to report positive net income for the third consecutive year, reflecting our strong execution and disciplined financial management," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "This execution was driven by both our continued commercial performance in the United States and abroad, as well as effective implementation of our planned initiatives to raise patient awareness and expand access channels. In addition, we are pleased to be able to initiate the ALI-1201/ALISCA-Breast1 Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in November, which is a significant step in our clinical development plan for alisertib."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from the Phase I trial of neratinib given in combination with trastuzumab deruxtecan in solid tumors with HER2 alterations (H1 2025); (ii) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (2025); and (iii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (2025).

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the fourth quarter of 2024, total revenue was $59.1 million, of which $54.4 million was product revenue, net and $4.7 million was royalty revenue. This compares to total revenue of $72.2 million for the fourth quarter of 2023, of which $53.2 million was product revenue, net and $19.0 million was royalty revenue. For the year ended December 31, 2024, total revenue was $230.5 million, of which $195.2 million was product revenue, net and $35.3 million was royalty revenue. This compares to total revenue in 2023 of $235.6 million, of which $203.1 million was product revenue, net and $32.5 million was royalty revenue. Puma reported no license revenue for the years ended December 31, 2024 and 2023.

Operating Costs and Expenses

Total operating costs and expenses were $45.7 million for the fourth quarter of 2024, compared to $57.4 million for the fourth quarter of 2023. Total operating costs and expenses were $199.5 million for full year 2024, compared to $203.0 million for full year 2023.

Cost of Sales

Cost of sales was $13.9 million for the fourth quarter of 2024, compared to $24.3 million for the fourth quarter of 2023. Cost of sales was $64.4 million for full year 2024, compared to cost of sales of $62.7 million for full year 2023. The $1.7 million increase in full year 2024 was primarily due to the increase of product unit sales to our sub-licensees and the related cost of sales (primarily sales in China), partially offset by lower domestic sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $16.6 million for the fourth quarter of 2024, compared to $20.2 million for the fourth quarter of 2023. SG&A expenses for full year 2024 were $80.2 million, compared to $89.9 million for full year 2023. The $9.7 million decrease in SG&A expenses for full year 2024 compared to 2023 resulted primarily from a decrease in professional fees and expenses of approximately $4.1 million, primarily due to a decrease in consultant and contractor expenses (primarily marketing related) of approximately $2.7 million, a decrease in legal fees of approximately $1.0 million, and a decrease in insurance and other expense of approximately $0.4 million; a decrease in payroll and related costs of approximately $1.9 million, primarily due to lower headcount, partially offset by annual salary increases; a decrease in provision for credit loss (recovery) of approximately $1.4 million, due to an overdue receivable as of December 31, 2023 that was collected in 2024; a decrease in stock-based compensation expense of approximately $1.3 million, primarily due to lower fair value on equity grants as a result of a lower market price for our common stock; and a decrease in loss on impairment of asset expense of $0.6 million in connection with our decision to sublease a portion of our leased office space in 2023, which was recorded as an operating asset in accordance with ASC 842.

Research and Development Expenses

Research and development (R&D) expenses were $15.2 million for the fourth quarter of 2024, compared to $12.9 million for the fourth quarter of 2023. R&D expenses for full year 2024 were $54.9 million, compared to $50.4 million for full year 2023. The $4.5 million increase in R&D expenses during full year 2024 compared to full year 2023 resulted from an increase in clinical trial expense of approximately $3.5 million, primarily due to the procurement of our alisertib drug product, as well as increased alisertib study activity, partially offset by the achievement of fewer clinical milestones; an increase in internal R&D of approximately $1.5 million, primarily due to higher compensation related to achieving company goals and one-time payroll and severance-related expenses; partially offset by a decrease in stock-based compensation of approximately $0.7 million, primarily due to lower fair value on equity grants as a result of a lower market price for our common stock.

Total Other Income (Expenses)

Total other expenses were $1.1 million for the fourth quarter of 2024, compared to total other expenses of $2.0 million for the fourth quarter of 2023. Total other expenses were $6.9 million for full year 2024, compared to $9.9 million for full year 2023. The $3.0 million decrease in other expenses in full year 2024 resulted primarily from a $2.1 million increase in interest income, which reflected higher balances in cash equivalents and marketable securities, and a $0.9 million decrease in interest expense, which was due to the pay down of debt in 2024, as well as ending imputed interest on $8.0 million related to the final installment payment of the Eshelman litigation settlement paid in October 2024.

Deferred Income Tax Benefit

In the fourth quarter of 2024, Puma released a portion of its valuation allowance resulting in a non-cash, deferred tax income benefit of $7.1 million. The valuation allowance was established to offset Puma’s deferred tax assets, which are primarily related to its historical losses. This significantly increased Puma’s net income for the fourth quarter and full year 2024.

First Quarter 2025 and Full Year 2025 Financial Outlook

First Quarter 2025

Full Year 2025

Net Product Revenue

$41–$43 million

$192–$198 million

Royalty Revenue

$1.5–$2.5 million

$20–$24 million

License Revenue

$0 million

$0 million

Net Income/(Loss)*

$(2)–$0 million

$23–$28 million

Gross to Net Adjustment

22.5%–23.5%

20.5%–21.5%

*There are no tax valuation allowance adjustments included in the outlook above.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2024 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, February 27, 2025. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On February 27, 2025 Oncopeptides reported year end report (Presentation, Oncopeptides, FEB 27, 2025, View Source [SID1234654165]).

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On February 27, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Cullinan Oncology, FEB 27, 2025, View Source [SID1234650700]).

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"Building on our execution throughout 2024, we are positioned to again deliver meaningful catalysts in 2025, starting with key updates for CLN-978 and zipalertinib," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "We have established an important competitive advantage in the immunology space as CLN-978 remains the first and only development-stage CD19 T cell engager with U.S. Food and Drug Administration (FDA) IND clearance in autoimmune diseases. We are further strengthening our leadership position by rapidly expanding our site footprint and preparing to deliver initial clinical data in SLE in the fourth quarter of 2025. For zipalertinib, we recently announced that the pivotal Phase 2b portion of the REZILIENT1 study met the primary endpoint of overall response rate. This milestone marks a significant achievement for Cullinan, our partner, Taiho, and most importantly, patients with EGFR exon20 insertion mutation NSCLC who have received prior therapy. Together with Taiho, we look forward to discussing next steps with the U.S. FDA and expect to submit an NDA in the second half of 2025. We look forward to continuing to progress these programs along with the rest of our pipeline."

Portfolio Highlights

Immunology

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CLN-978 (CD19xCD3 T cell engager): Systemic lupus erythematosus and rheumatoid arthritis
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The global Phase 1 study in moderate to severe SLE is ongoing with site expansion in the United States, Europe and Australia, and the Company plans to share initial clinical data in the fourth quarter of 2025.

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The Company remains on track to initiate a Phase 1 study in rheumatoid arthritis (RA) in the second quarter of 2025. The company-sponsored trial will be designed and executed in collaboration with FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Italy.
Oncology

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CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors and hematological malignancies
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The Company continues enrollment of disease-specific expansion cohorts of its Phase 1 study. Cullinan remains on track to report initial data for endometrial and cervical cancers in the second quarter of 2025.
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Enrollment continues in the ongoing Phase 1 study of CLN-619 in patients with relapsed/refractory multiple myeloma.
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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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In January 2025, Cullinan announced that the pivotal Phase 2b portion of REZILIENT1 met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The full results will be submitted for presentation at an upcoming international medical conference and shared mid-year 2025. Pending discussions with the U.S. FDA, Taiho and Cullinan plan to submit for U.S. regulatory approval in the second half of 2025. Taiho continues enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC.
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CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
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Enrollment continues in the ongoing Phase 1 study in patients with relapsed/refractory AML or MDS, and in the ongoing Phase 1 study in patients with measurable residual disease (MRD) in AML.
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CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
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Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.
Fourth Quarter and Full Year 2024 Financial Results

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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $606.9 million as of December 31, 2024. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.

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R&D Expenses: Research and development expenses were $40.5 million for the fourth quarter of 2024, compared to $34.8 million for the same period in 2023, and $142.9 million for the full year 2024, compared to $148.2 million for the full year 2023.
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G&A Expenses: General and administrative expenses were $14.6 million for the fourth quarter of 2024, compared to $10.6 million for the same period in 2023, and $54.0 million for the full year 2024, compared to $42.5 million for the full year 2023.
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Net Loss: Net loss attributable to Cullinan was $47.6 million for the fourth quarter of 2024, compared to $23.8 million for the same period in 2023, and $167.4 million for the full year 2024, compared to $153.2 million for the full year 2023.

On February 27, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 11:10 a.m. ET in Boston, Mass (Press release, Supernus, FEB 27, 2025, View Source [SID1234650718]).

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Investors interested in arranging a meeting with company management during the conference should contact the TD Cowen conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.