Acquisition and Merger - The company completed the acquisition of Spectrum Pharmaceuticals on July 31, 2023, under a merger agreement, enhancing its portfolio in oncology products [116]. - Each share of Spectrum common stock was converted into the right to receive 0.1783 shares of the company's common stock and a contingent value right worth up to $0.20 per share based on future sales of ROLVEDON [117][119]. - The company anticipates that the results of Spectrum will be included in its consolidated financial statements from the effective date of the merger [119]. Financial Performance - Total revenues for the three months ended June 30, 2023, were $40.99 million, an increase of 2.4% from $35.13 million in the same period of 2022 [130]. - Total product sales, net, for the six months ended June 30, 2023, were $81.85 million, an increase of 15.4% from $70.98 million in the same period of 2022 [130]. - For the six months ended June 30, 2023, net income was $5.0 million, a decrease from $16.9 million for the same period in 2022 [166]. - Cash provided by operating activities was $41.3 million for the six months ended June 30, 2023, compared to $41.9 million in the same period in 2022 [165]. - Cash used in investing activities for the six months ended June 30, 2023, was $0.8 million, significantly lower than $16.5 million in the same period in 2022 [167]. - Cash used in financing activities for the six months ended June 30, 2023, was $35.3 million, compared to $9.9 million in the same period in 2022 [168]. Product Sales and Market Competition - INDOCIN net product sales increased by $5.2 million to $28.1 million for the three months ended June 30, 2023, compared to $22.8 million in 2022, driven by favorable net pricing despite a decrease in volume [132]. - Otrexup net product sales rose by $1.0 million to $3.6 million for the three months ended June 30, 2023, compared to $2.6 million in 2022, primarily due to higher volume [133]. - CAMBIA net product sales decreased by $4.4 million to $1.8 million for the three months ended June 30, 2023, compared to $6.2 million in 2022, mainly due to lower volume from generic competition [134]. - A generic version of INDOCIN Suppositories received FDA approval in August 2023, which may impact future sales and market competition [121][124]. - The company is focused on maintaining its market position despite the entry of generics and is developing strategies to enhance sales and marketing efforts [123][124]. Expenses and Financial Management - Selling, general, and administrative expenses increased by $6.2 million to $16.8 million for the three months ended June 30, 2023, primarily due to costs associated with the Spectrum Merger and higher marketing expenses [142]. - Research and development expenses were $0.5 million for both the three and six months ended June 30, 2023, representing costs associated with the proposed clinical trial for INDOCIN suppositories [141]. - Amortization of intangible assets decreased to $6.28 million for the three months ended June 30, 2023, from $7.97 million in 2022, primarily due to the full amortization of CAMBIA and Zipsor intangible assets [146]. - Other expense decreased from $2.36 million to $0.09 million for the three months ended June 30, 2023, primarily due to lower interest expenses [147]. - Debt-related expenses for the six months ended June 30, 2023, included an induced conversion expense of approximately $8.8 million related to a $30.0 million transaction [148]. - For the three and six months ended June 30, 2023, total interest expense decreased by $1.5 million and $2.7 million, respectively, compared to the same period in 2022, primarily due to lower interest incurred on outstanding debt [150]. Future Outlook and Strategy - The company expects potential future payments from the contingent value rights based on achieving specific sales targets for ROLVEDON, with $175 million in sales expected for 2024 and $225 million for 2025 [119]. - The company is committed to executing its business strategy, including product acquisitions and partnerships, to drive future growth [124]. - The company expects existing cash to be sufficient to fund operations and required payments under debt agreements for the next twelve months [159]. Tax and Financing Activities - The company recorded an income tax expense of $3.9 million for the three months ended June 30, 2023, representing an effective tax rate of 31.3% [152]. - The company completed a Convertible Note Exchange, exchanging $30.0 million principal amount of 2027 Convertible Notes for 6,990,000 shares of common stock and $10.5 million in cash [157]. - The company issued $70.0 million in aggregate principal amount of 2027 Convertible Notes, which are expected to reduce future cash interest expenses [156]. - The company has an ATM offering program with an aggregate offering price of up to $25.0 million, which was suspended following the issuance of the 2027 Convertible Notes [159]. Risks and Challenges - The company faces risks related to litigation, regulatory compliance, and market conditions that could affect its financial performance and operational results [126][127].

Assertio Holdings Inc. (NASDAQ:ASRT) Q2 2023 Earnings Call Transcript August 3, 2023 4:30 PM ET Company Participants Matt Kreps - Investor Relations Dan Peisert - President and CEO Paul Schwichtenberg - Senior Vice President and CFO Tom Riga - Outgoing CEO of Spectrum Pharmaceuticals Conference Call Participants Thomas Flaten - Lake Street Capital Markets Hamed Khorsand - BWS Financial Inc Jim Sidoti - SIDOTI & Company Scott Henry - Roth Capital Operator Good morning, and welcome to the Assertio Holdings In ...

Assertio Holdings, Inc. (NASDAQ:ASRT) Q4 2022 Earnings Conference Call March 8, 2023 4:30 PM ET Company Participants Matt Kreps - Darrow Associates, Investor Relations Dan Peisert - President & Chief Executive Officer Paul Schwichtenberg - Senior Vice President & Chief Financial Officer Conference Call Participants Thomas Flaten - Lake Street Scott Henry - ROTH Capital Hamed Khorsand - BWS Financial Mitra Ramgopal - Sidoti Operator Good afternoon and welcome to the Assertio Holdings' Fourth Quarter and Full ...

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, 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 001-39294 ASSERTIO HOLDINGS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) Delaware 85-0598378 (STATE OR OTHER JURISDICTION OF (I ...

Assertio Holdings, Inc. Q4 2022 Financial Results -ASSERTIO= About This Presentation Statements in this communication that are not statements of historical fact are forward-looking statements that reflect Assertio's current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on 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 ...

Financial Reporting and Estimates - The preparation of financial statements requires management to make estimates and assumptions that could lead to material differences in actual results [180]. Drug Development Risks - The development of drug candidates is inherently difficult and uncertain, with significant risks of delays and failures in clinical trials [182]. - Regulatory approval processes are expensive and time-consuming, and delays could impair the ability to commercialize future products [189]. - The company relies on third-party organizations for clinical trials, which may affect the timing and success of obtaining regulatory approvals [185]. - Any significant delays in the governmental approval process could adversely impact the company's financial condition and results of operations [184]. - The company may need to perform additional clinical studies to support changes from approved products, which could further delay commercialization [191]. - The entry of generic competitors could significantly affect the market success of the company's products [193]. Market and Stock Performance - The trading price of the company's common stock has historically been volatile, influenced by various external factors [191]. - The company is currently in compliance with the Nasdaq's Bid Price Rule, which requires a minimum bid price of at least $1.00 per share [198]. - A failure to comply with the Bid Price Rule in the future could lead to delisting from the Nasdaq Capital Market, adversely affecting market liquidity and stock price [199]. - The company has previously required a grace period and implemented a one-for-four reverse stock split to maintain compliance with Nasdaq listing standards [198]. - The company is classified as a "smaller reporting company," which allows it to take advantage of reduced disclosure requirements, potentially making its stock less attractive to investors [200]. Corporate Governance and Shareholder Relations - The company may face significant costs and management distractions from potential proxy contests initiated by activist shareholders [201]. - The company is subject to risks related to unsolicited takeover attempts, which could disrupt business operations and financial results [202]. - The company may encounter difficulties in obtaining shareholder approval for significant corporate actions due to its retail investor base [199]. Legal and Financial Obligations - Legal and regulatory developments, including litigation and investigations, could impact the company's operations and financial performance [195]. - The company must generate sufficient cash flow to fund operations and meet its debt obligations [195]. - Variations in revenues from commercialization agreements and other contract revenues could affect financial metrics and projections [195].

Financial Data and Key Metrics Changes - Net product sales for Q3 2022 were $34.3 million, up from $26 million in the prior year quarter and down from $35.4 million in the previous quarter [20] - Adjusted EBITDA for Q3 2022 was $21.4 million, compared to $22.9 million last quarter and $15.8 million in the prior year quarter [24] - Net income for Q3 2022 was $4.2 million, compared to $7.8 million last quarter and $3.7 million in the prior year quarter [26] - Gross margin for Q3 2022 was 88.3%, with a slight adjustment due to a one-time returns accrual benefit [23] Business Line Data and Key Metrics Changes - INDOCIN family net sales increased by $7.3 million year-over-year, primarily due to higher net pricing [21] - Otrexup net sales for Q3 2022 were $3 million, up from $2.6 million in the prior quarter [21] - CAMBIA net sales decreased by $400,000 compared to the prior year quarter due to lower volume [22] Market Data and Key Metrics Changes - The company exited the Medicaid drug rebate program, which is expected to increase annual net revenue and profit by $6 million [12][14] - The acquisition of Sympazan is projected to add between $4 million to $4.5 million in annual adjusted EBITDA [15] Company Strategy and Development Direction - The company has pivoted towards growth after restructuring and improving profitability [7] - Key priorities include retaining employees, proving the efficacy of the new commercial model, reducing concentration in INDOCIN, and improving the balance sheet [8][10] - The company aims to diversify its business and has a robust M&A pipeline, with a goal of acquiring products that bring an additional $50 million in gross profit by 2024 [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand from the 340B hospital segment despite limited data [36] - The company is confident in its ability to grow and meet its goals, with a favorable M&A environment and capabilities to evaluate multiple transactions simultaneously [60] - The company expects to see a return to normal channel inventory levels, which should positively impact net product sales for INDOCIN [32] Other Important Information - The company raised its guidance for 2022, expecting product net sales to exceed $141 million and adjusted EBITDA to be greater than $86 million [31] - The company has successfully extended its debt maturity and reduced its cost of debt capital from 13% to 6.5% [7][10] Q&A Session Summary Question: Insights into demand from the 340B hospital segment - Management indicated limited insight due to data lag but remains optimistic about future demand [36] Question: Status of Otrexup sampling - Management confirmed that deliveries are on schedule and manufacturing timelines are being met [38] Question: Details on the pre-IND meeting with the FDA - Management stated that a single-arm trial is proposed, with specifics pending FDA feedback [40] Question: Impact of exiting the 340B program on revenues - Management clarified that exiting the program will save costs as previous sales were unprofitable [44] Question: Comfort level with returning to R&D - Management is actively recruiting for a Head of Medical to support clinical programs and is confident in the approach [47] Question: Long-term sales expectations for Otrexup - Management believes reaching a $4 million quarterly run rate is achievable [50] Question: Amortization expense for Sympazan - Management confirmed an amortization of $1.6 million per year over 10 years [52] Question: Expectations for Sympazan's growth - Management plans to integrate existing payer contracts and is optimistic about the asset's performance [66] Question: Overall growth expectations for 2023 - Management aims for growth in 2023 but did not provide specific guidance [68]

Financial Performance - Q4 2021 - Net product sales increased to $32152 thousand, a 24% increase compared to Q3 2021 and a 7% increase compared to Q4 2020[5] - Adjusted EBITDA reached $17827 thousand, a 13% increase compared to Q3 2021 and a significant 118% increase compared to Q4 2020[6] Financial Performance - Full Year 2021 - Net product sales reached $109420 thousand, a 19% increase compared to 2020[7] - Adjusted EBITDA reached $48830 thousand, a substantial 200% increase compared to 2020[7] Cost Savings - Adjusted SG&A expenses decreased by $24923 thousand, a 34% reduction compared to 2020[10] - Adjusted SG&A expenses excluding one-time legal matters were $42554 thousand, reflecting approximately $45 million of savings versus the annualized second half run rate in 2020[10] Cash Balance & Debt - Cash and cash equivalents were $36810 thousand[12] - Net debt was $33940 thousand[12] - Net debt to Adjusted EBITDA ratio improved to 0.70 in 2021 from 3.65 in 2020[13] 2022 Guidance - Net product sales are projected to be between $126 million and $136 million[14] - Adjusted EBITDA is projected to be between $64 million and $72 million[14]

Spectrum Pharmaceuticals, Inc. (SPPI) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Joseph Turgeon - President and Chief Executive Officer Kurt Gustafson - Executive Vice President and Chief Financial Officer Francois Lebel - Executive Vice President and Chief Medical Officer Conference Call Participants Alethia Young - Cantor Fitzgerald Maury Raycroft - Jefferies Ed White - HC Wainwright & Co. Mayank Mamtani - B. Riley Securities Reni Benjamin - JMP Securities Operator ...

Study Objective and Design - The ZENITH20 study is a Phase 2, open-label, multi-cohort, multi-center trial evaluating poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations[3] - Cohort 5 of ZENITH20 randomizes patients to different arms with varying doses of poziotinib: 10, 12, and 16 mg QD or 6 and 8 mg BID[3] Safety and Tolerability - Poziotinib demonstrates improved tolerability with BID dosing compared to QD dosing at both 8mg and 6mg BID[16] - The incidence of ≥Grade 3 related Adverse Events (AEs) was lower in the 8mg BID group (26%) compared to the 16mg QD group (50%)[8] - Drug interruption was less frequent in the 6mg BID group (50%) compared to the 16mg QD group (82%)[9] - Dose reduction was less frequent in the 10mg QD group (34%) compared to the 16mg QD group (59%)[9] Efficacy - Preliminary response data suggests improved anti-tumor activity with 8mg BID dosing compared to 10, 12, 16mg QD or 6mg BID[17] - The Overall Response Rate (ORR) in the 8mg BID group was 316% compared to 158% in the 16mg QD and 12mg QD groups, and 53% in the 6mg BID and 10mg QD groups[10] - The Disease Control Rate (DCR) in the 8mg BID group was 684% compared to 526% in the 16mg QD group[10]