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Assertio (ASRT) - 2021 Q2 - Quarterly Report
2021-08-04 16:00
[Financial Overview](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This section provides a comprehensive overview of Assertio's financial performance, position, cash flows, and key asset and liability structures [Financial Performance (Income Statement)](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20INCOME) Assertio reported increased Q2 2021 revenues of **$25.4 million** and a narrowed net loss, with six-month revenues growing to **$52.2 million** Financial Performance Summary | Financial Metric | Three Months Ended June 30, 2021 (in thousands) | Three Months Ended June 30, 2020 (in thousands) | Six Months Ended June 30, 2021 (in thousands) | Six Months Ended June 30, 2020 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | $25,373 | $20,617 | $52,213 | $41,534 | | **Loss from Operations** | $(12,001) | $(25,752) | $(4,492) | $(42,384) | | **Net (Loss) Income** | $(14,169) | $(34,499) | $(9,625) | $6,731 | | **Diluted Net (Loss) Income per Share** | $(0.32) | $(1.40) | $(0.23) | $0.30 | [Financial Position (Balance Sheet)](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2021, Assertio's total assets were **$312.0 million**, with cash and cash equivalents significantly increasing to **$54.4 million** and total shareholders' equity improving to **$92.3 million** Balance Sheet Summary | Balance Sheet Item | June 30, 2021 (in thousands) | December 31, 2020 (in thousands) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $54,428 | $20,786 | | **Total current assets** | $119,348 | $94,254 | | **Intangible assets, net** | $186,318 | $200,082 | | **Total assets** | $312,016 | $303,274 | | **Total current liabilities** | $116,914 | $132,686 | | **Total liabilities** | $219,751 | $247,760 | | **Total shareholders' equity** | $92,265 | $55,514 | [Cash Flow Statement](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Net cash used in operating activities significantly improved to **$(3.3) million** in H1 2021, with financing activities providing **$36.9 million**, resulting in a **$33.6 million** net increase in cash Cash Flow Summary | Cash Flow Activity | Six Months Ended June 30, 2021 (in thousands) | Six Months Ended June 30, 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,262) | $(45,159) | | Net cash provided by investing activities | $0 | $512,802 | | Net cash provided by (used in) financing activities | $36,904 | $(450,347) | | **Net increase in cash and cash equivalents** | **$33,642** | **$17,296** | [Revenue Analysis](index=7&type=section&id=NOTE%202.%20REVENUE) Q2 2021 total revenue increased to **$25.4 million** driven by Zyla merger products, while H1 2021 total revenue reached **$52.2 million** with no NUCYNTA commercialization revenue Product Sales, Net | Product Sales, net | Three Months Ended June 30, 2021 (in thousands) | Three Months Ended June 30, 2020 (in thousands) | Six Months Ended June 30, 2021 (in thousands) | Six Months Ended June 30, 2020 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | INDOCIN products | $13,075 | $5,434 | $27,673 | $5,434 | | CAMBIA | $6,128 | $7,780 | $12,590 | $14,054 | | Zipsor | $2,581 | $3,535 | $4,803 | $5,866 | | SPRIX | $2,942 | $1,602 | $4,639 | $1,602 | | **Total product sales, net** | **$24,831** | **$20,165** | **$51,238** | **$29,417** | - The company began recognizing product sales for INDOCIN and SPRIX following the Zyla Merger on May 20, 2020, which is the primary driver for the year-over-year increase in product sales[27](index=27&type=chunk) - The company ceased recognizing commercialization revenue for NUCYNTA after its sale on February 13, 2020. In the first six months of 2020, this segment had generated **$11.3 million** in net revenue[29](index=29&type=chunk)[121](index=121&type=chunk) [Debt Structure](index=11&type=section&id=NOTE%209.%20DEBT) Assertio's total debt principal decreased to **$79.0 million** as of June 30, 2021, primarily comprising **$75.5 million** in 13% Senior Secured Notes due 2024 Debt Components | Debt Component | June 30, 2021 (in thousands) | December 31, 2020 (in thousands) | | :--- | :--- | :--- | | 13% Senior Secured Notes due 2024 | $75,500 | $80,250 | | Royalty rights obligation | $3,138 | $3,533 | | 2.50% Convertible Notes due 2021 | $335 | $335 | | **Total principal amount** | **$78,973** | **$84,118** | - The **13% Senior Secured Notes** require principal payments of **10% per annum**, payable semi-annually, and are secured by a lien on substantially all assets of the company[49](index=49&type=chunk)[50](index=50&type=chunk) - The company was in compliance with all debt covenants as of June 30, 2021, including a minimum liquidity requirement[52](index=52&type=chunk) [Intangible Assets](index=10&type=section&id=NOTE%206.%20INTANGIBLE%20ASSETS) Net intangible assets decreased to **$186.3 million** as of June 30, 2021 due to amortization, with INDOCIN and SPRIX product rights being the largest components Intangible Assets Net Book Value | Intangible Asset (Net Book Value) | June 30, 2021 (in thousands) | December 31, 2020 (in thousands) | | :--- | :--- | :--- | | INDOCIN | $139,867 | $146,288 | | SPRIX | $32,825 | $35,611 | | CAMBIA | $11,925 | $15,197 | | Zipsor | $1,700 | $2,869 | | **Total Intangible Assets** | **$186,318** | **$200,082** | - Amortization expense increased to **$7.2 million** in Q2 2021 from **$4.9 million** in Q2 2020, primarily due to the timing of the Zyla Merger in May 2020, which added INDOCIN and SPRIX product rights[38](index=38&type=chunk)[130](index=130&type=chunk) - The company expects to recognize **$14.4 million** in amortization expense for the remainder of 2021 and **$26.9 million** for the full year 2022[40](index=40&type=chunk) [Management's Discussion and Analysis](index=22&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on Assertio's financial condition, results of operations, and liquidity [Company Overview and COVID-19 Impact](index=25&type=section&id=COMPANY%20OVERVIEW) Assertio is a commercial pharmaceutical company focused on neurology, hospital, and pain/inflammation products, adapting its commercial approach due to COVID-19 impacts on in-person visits and elective procedures - The company's commercial portfolio focuses on three areas: neurology, hospital, and pain and inflammation[112](index=112&type=chunk) - Primary marketed products are INDOCIN, CAMBIA, SPRIX, and Zipsor[113](index=113&type=chunk) - Due to COVID-19, the company adapted its commercial approach by increasing virtual visits and experienced prescription volatility due to limitations on elective surgeries[114](index=114&type=chunk)[23](index=23&type=chunk) [Results of Operations Analysis](index=26&type=section&id=RESULTS%20OF%20OPERATIONS) Q2 2021 revenue growth was driven by Zyla-acquired products, while cost of sales decreased due to non-recurring charges, and SG&A and R&D expenses were significantly reduced - Cost of sales in Q2 2021 decreased by **$1.3 million** year-over-year, mainly because a **$2.4 million** inventory step-up expense from the Zyla Merger in Q2 2020 was not repeated[124](index=124&type=chunk)[125](index=125&type=chunk) - R&D expenses decreased to **zero** in Q2 and H1 2021, as the company completed all material research and development activities in 2020[126](index=126&type=chunk) - SG&A expenses for the six months ended June 30, 2021 decreased by **$21.5 million**, driven by the absence of 2020 one-time transaction costs, restructuring savings, and a **$5.0 million** insurance reimbursement for opioid-related expenses[127](index=127&type=chunk)[86](index=86&type=chunk) - Other (expense) income changed significantly due to large one-time events in 2020, including the gain on sale of Gralise (**$126.7 million**), loss on sale of NUCYNTA (**$(14.7) million**), and loss on extinguishment of convertible notes (**$(47.9) million**), which did not recur in 2021[134](index=134&type=chunk)[135](index=135&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Assertio significantly improved liquidity in H1 2021 through **$45.3 million** in net proceeds from stock offerings, with management confident in sufficient cash for the next twelve months - In February 2021, the company completed two registered direct offerings, raising gross proceeds of approximately **$14.0 million** and **$34.3 million**, respectively[140](index=140&type=chunk) - Management believes that existing cash will be sufficient to fund operations for the next twelve months from the filing date[141](index=141&type=chunk) - Cash used in operating activities decreased to **$3.3 million** in H1 2021 from **$45.2 million** in H1 2020, driven by favorable working capital changes and lower non-cash adjustments[144](index=144&type=chunk) [Legal and Risk Disclosures](index=31&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section details Assertio's material legal proceedings, risk factors, and the effectiveness of its internal controls and procedures [Legal Proceedings](index=15&type=section&id=ITEM%201.%20LEGAL%20PROCEEDING) The company faces ongoing Glumetza antitrust and opioid litigation, recorded an **$11.3 million** loss contingency, and settled a securities class action lawsuit in July 2021 - A loss contingency provision of **$11.3 million** was recognized in the three and six months ended June 30, 2021[74](index=74&type=chunk) - In the Glumetza antitrust litigation, the court denied all motions for summary judgment, and a trial is expected around October 2021. A liability for this matter has been recorded[76](index=76&type=chunk)[77](index=77&type=chunk) - The company reached an agreement to settle the securities class action lawsuit and related derivative actions on July 30, 2021. A liability has been recorded for these matters[78](index=78&type=chunk)[79](index=79&type=chunk) - The company is named in multidistrict and state-level opioid litigation and intends to defend itself vigorously[82](index=82&type=chunk)[83](index=83&type=chunk) [Risk Factors](index=31&type=section&id=ITEM%201A.%20RISK%20FACTORS) No material changes to risk factors since the 2020 10-K, with key forward-looking risks including COVID-19 impacts, litigation outcomes, and commercial success - There have been no material changes to risk factors since the Annual Report on Form 10-K for the year ended December 31, 2020[153](index=153&type=chunk) - Key forward-looking risks include: COVID-19 impacts, success of restructuring plans, integration of the Zyla merger, commercial success of products, outcome of opioid and antitrust litigation, and ability to manage indebtedness[108](index=108&type=chunk) [Controls and Procedures](index=31&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded disclosure controls and procedures were effective as of June 30, 2021, following the finalization of Zyla operations integration into internal controls - Management concluded that disclosure controls and procedures were effective as of the end of the quarter[149](index=149&type=chunk) - The integration of Zyla's operations into the company's internal control environment was finalized during the first quarter of 2021[151](index=151&type=chunk)
Assertio (ASRT) - 2021 Q1 - Earnings Call Transcript
2021-05-14 02:18
Spectrum Pharmaceuticals, Inc. (SPPI) Q1 2021 Earnings Conference Call May 13, 2021 4:30 PM ET Company Participants Kurt Gustafson - Chief Financial Officer Joe Turgeon - President and Chief Executive Officer Francois Lebel - Chief Medical Officer Conference Call Participants Maury Raycroft - Jefferies Ed White - H.C. Wainwright Ren Benjamin - JMP Securities Charles Zhu - Guggenheim Securities Mayank Mamtani - B. Riley Operator Good afternoon, ladies and gentlemen and welcome to the Spectrum Pharmaceuticals ...
Assertio (ASRT) - 2021 Q1 - Quarterly Report
2021-05-05 16:00
PART I — FINANCIAL INFORMATION This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited condensed consolidated financial statements and notes for Q1 2021 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and shareholders' equity at specific dates Balance Sheet Items | ASSETS/LIABILITIES | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :----------------- | :---------------------------- | :------------------------------- | | Cash and cash equivalents | $61,033 | $20,786 | | Total current assets | $124,069 | $94,254 | | Total assets | $325,424 | $303,274 | | Total current liabilities | $109,090 | $132,686 | | Total liabilities | $220,121 | $247,760 | | Shareholders' Equity | $105,303 | $55,514 | - Total assets **increased by $22.15 million** from December 31, 2020, to March 31, 2021, primarily driven by a **significant increase in cash and cash equivalents**[7](index=7&type=chunk) - Total liabilities **decreased by $27.64 million**, mainly due to a reduction in current liabilities, particularly accrued rebates, returns, and discounts, and accrued liabilities[7](index=7&type=chunk) [Condensed Consolidated Statements of Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) This section reports the company's revenues, expenses, and net income over specific periods Comprehensive Income Metrics | Metric | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :-------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Total revenues | $26,839 | $20,917 | | Total costs and expenses | $19,332 | $37,549 | | Income (Loss) from operations | $7,507 | $(16,632) | | Total other (expense) income | $(2,415) | $59,910 | | Net income and Comprehensive income | $4,544 | $41,230 | | Basic net income per share | $0.03 | $0.51 | | Diluted net income per share | $0.03 | $0.51 | - Total revenues **increased by $5.92 million** (**28.3%**) year-over-year, primarily driven by product sales from newly acquired INDOCIN and SPRIX products[10](index=10&type=chunk) - The company **swung from an operating loss of $16.63 million** in Q1 2020 to an **operating income of $7.51 million** in Q1 2021, largely due to reduced selling, general and administrative expenses[10](index=10&type=chunk) - Net income **decreased significantly** from **$41.23 million** in Q1 2020 to **$4.54 million** in Q1 2021, mainly due to a large one-time gain on the sale of Gralise in the prior year[10](index=10&type=chunk) [Condensed Consolidated Statements of Shareholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity) This section details changes in the company's equity accounts, including common stock and retained earnings Shareholders' Equity Summary | Metric | December 31, 2020 (in thousands) | March 31, 2021 (in thousands) | | :-------------------------------- | :------------------------------- | :---------------------------- | | Common Shares (in thousands) | 113,569 | 173,744 | | Stock Amount (in thousands) | $13 | $18 | | Additional Paid-In Capital (in thousands) | $483,446 | $528,686 | | Accumulated Earnings (Deficit) (in thousands) | $(427,945) | $(423,401) | | Shareholders' Equity (in thousands) | $55,514 | $105,303 | - Shareholders' equity **increased by $49.79 million** from December 31, 2020, to March 31, 2021, primarily driven by the issuance of common stock in connection with stock offerings (**$44.86 million**) and net income (**$4.54 million**)[13](index=13&type=chunk) - Common shares outstanding **increased significantly** from **113,569 thousand** to **173,744 thousand**, largely due to the issuance of **57,600 thousand** shares in stock offerings[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary | Cash Flow Activity | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :-------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net cash used in operating activities | $(4,226) | $(25,063) | | Net cash provided by investing activities | — | $449,036 | | Net cash provided by (used in) financing activities | $44,473 | $(360,107) | | Net increase in cash and cash equivalents | $40,247 | $63,866 | | Cash and cash equivalents at end of period | $61,033 | $105,973 | - Net cash used in operating activities **decreased significantly** from **$25.06 million** in Q1 2020 to **$4.23 million** in Q1 2021, primarily due to the prior year's divestitures of Gralise and NUCYNTA[17](index=17&type=chunk)[135](index=135&type=chunk) - Net cash provided by financing activities was **$44.47 million** in Q1 2021, a **substantial increase** from the **$360.11 million** used in Q1 2020, driven by proceeds from registered direct stock offerings in February 2021[17](index=17&type=chunk)[137](index=137&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of comprehensive income, statements of shareholders' equity, and statements of cash flows, along with detailed notes explaining significant accounting policies, revenue breakdown, asset and liability components, debt, equity, and commitments for the quarter ended March 31, 2021 [NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=7&type=section&id=NOTE%201.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines significant accounting policies, SEC compliance, and the impact of COVID-19 on company operations - The company adapted to COVID-19 by initiating remote work and increasing virtual visits with providers due to limitations on in-person interactions[23](index=23&type=chunk) - COVID-19 led to a decline in prescriptions associated with elective surgeries, impacting the company's product sales[23](index=23&type=chunk) [NOTE 2. REVENUE](index=7&type=section&id=NOTE%202.%20REVENUE) This note disaggregates Q1 2021 and 2020 revenue by type, highlighting Zyla Merger product sales and NUCYNTA divestiture impacts Revenue Breakdown by Type | Revenue Type | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :-------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Product sales, net | $26,405 | $9,252 | | Commercialization agreement, net | — | $11,258 | | Royalties and milestones | $434 | $407 | | Total revenues | $26,839 | $20,917 | - Product sales, net, **increased significantly** to **$26.41 million** in Q1 2021 from **$9.25 million** in Q1 2020, primarily due to the acquisition of INDOCIN Products (**$14.60 million**) and SPRIX (**$1.70 million**) from the Zyla Merger in May 2020[26](index=26&type=chunk)[27](index=27&type=chunk) - Commercialization agreement revenue **ceased** in Q1 2021, compared to **$11.26 million** in Q1 2020, following the sale of the NUCYNTA franchise in February 2020[26](index=26&type=chunk)[29](index=29&type=chunk) [NOTE 3. ACCOUNTS RECEIVABLES, NET](index=9&type=section&id=NOTE%203.%20ACCOUNTS%20RECEIVABLES,%20NET) This note details the components of accounts receivable, net, as of March 31, 2021, and December 31,
Spectrum Pharmaceuticals (SPPI) Presents At AACR Virtual Meeting 2021 - Slideshow
2021-04-12 19:49
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]
Assertio (ASRT) - 2020 Q4 - Earnings Call Transcript
2021-03-31 00:22
Spectrum Pharmaceuticals, Inc. (SPPI) Q4 2020 Earnings Conference Call March 30, 2021 4:30 PM ET Company Participants Kurt Gustafson - Chief Financial Officer Joe Turgeon - President and CEO Dr. François Lebel - Chief Medical Officer Tom Riga - Chief Operating Officer Conference Call Participants Maury Raycroft - Jefferies Emilia Falcetti - Cantor Fitzgerald Ed White - H.C. Wainwright Sahil Kazmi - B. Riley Securities Reni Benjamin - JMP Securities Operator Ladies and gentlemen, thank you for standing by. A ...
Assertio (ASRT) - 2020 Q3 - Quarterly Report
2020-11-06 17:49
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 SEPTEMBER 30, 2020 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 O ...
Assertio (ASRT) - 2020 Q3 - Earnings Call Transcript
2020-11-06 16:58
Assertio Holdings, Inc. (NASDAQ:ASRT) Q3 2020 Earnings Conference Call November 6, 2020 8:30 AM ET Company Participants Lee Roth - Burns McClellan Todd Smith - President, CEO and Director Dan Peisert - Chief Financial Officer Mark Strobeck - Chief Operating Officer Conference Call Participants Scott Henry - ROTH Capital Sally Yanchus - Brookline Capital Kevin Kedra - G.research Operator Good morning, ladies and gentleman, and welcome to the Quarter Three 2020 Assertio Therapeutics Incorporated Earnings Conf ...