Anika Therapeutics
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Anika Therapeutics(ANIK) - 2022 Q4 - Annual Report
2023-03-15 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ 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 001-14027 Anika Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware (State or Other Jurisdiction of Incorpor ...
Anika Therapeutics(ANIK) - 2022 Q4 - Earnings Call Presentation
2023-03-07 00:54
Q4 AND YEAR-END 2022 EARNINGS CALL MARCH 6, 2023 ANIKA. RESTORE ACTIVE LIVING.™ SAFE HARBOR STATEMENTS Cautionary Note on Forward-looking Statements The statements made in, and during the course of, this presentation that are not statements of historical fact, including those related to the Company's commercial capabilities, initiatives and production, its product pipeline and associated timelines, its upcoming corporate milestones, and its growth strategy and projections, are forward looking statements wit ...
Anika Therapeutics(ANIK) - 2022 Q4 - Earnings Call Transcript
2023-03-07 00:48
Anika Therapeutics, Inc. (NASDAQ:ANIK) Q4 2022 Earnings Conference Call March 6, 2023 5:00 PM ET Company Participants Mark Namaroff - VP, IR, ESG and Corporate Communications Cheryl Blanchard - President & CEO Mike Levitz - EVP & CFO Conference Call Participants George Sellers - Stephens Jim Sidoti - Sidoti & Company Mike Petusky - Barrington Research Operator Greetings, and welcome to Anika's Fourth Quarter and Year-End 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode ...
Anika Therapeutics(ANIK) - 2022 Q3 - Earnings Call Transcript
2022-11-09 01:31
Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was $40.3 million, an increase of 2% year-over-year, driven by joint preservation and restoration, and last time buys in non-orthopedic sales [33] - Revenue in the OA Pain Management segment decreased by 2% to $25.7 million due to ordering patterns from J&J Mitek [33] - Adjusted gross margin was 67%, up from 66% in the previous year [34] - Net loss for the quarter was $4.2 million or $0.29 per share, compared to net income of $600,000 or $0.04 per share in Q3 2021 [36] - Adjusted EBITDA was $4.1 million, down from $5.7 million in the same quarter last year [37] Business Line Data and Key Metrics Changes - Joint preservation and restoration revenue increased by 6% to $11.8 million, limited by market dynamics and supply chain challenges [33] - Non-orthopedic revenue increased to $2.8 million compared to $2.2 million last year due to last time buys for certain legacy products [34] - The company continues to benefit from newer products like Tactoset and market-leading HA-based OA pain management solutions [10] Market Data and Key Metrics Changes - The joint preservation market is expected to grow significantly, with the rotator cuff repair market alone valued at nearly $600 million [20] - The company has seen strong international sales, particularly in viscosupplements, which have continued to perform well [10][33] - The overall market dynamics have been impacted by supply chain issues and the recovery of elective procedures, with hip and knee surgeries recovering faster than sports extremity and trauma segments [49] Company Strategy and Development Direction - The company aims to become a global leader in joint preservation, leveraging its OA Pain Management franchise to invest in adjacent high-growth markets [12] - A transformational strategy has expanded the market opportunity from $1 billion to over $8 billion [28] - The company is focused on launching multiple new products, including X-Twist, to drive growth in the joint preservation market [22][43] Management's Comments on Operating Environment and Future Outlook - Management acknowledges ongoing supply chain challenges but expects some relief as they move towards the full release of X-Twist in early 2023 [49] - The company remains optimistic about the joint preservation business despite adjusting growth expectations due to supply chain issues [51] - Management is confident in the differentiated clinical benefits of CINGAL and plans to engage with the FDA regarding U.S. regulatory approval [18][73] Other Important Information - The company has a strong cash position of $87.8 million and no outstanding debt [38] - The company is actively investing in R&D and commercial transformation to support growth objectives [42] - The company has received positive feedback from surgeons regarding new product launches, indicating strong demand [51] Q&A Session Summary Question: What are the underlying macro conditions and supply chain improvements? - Management noted that supply chain issues are prevalent across the market, but they expect some relief as they approach the full release of X-Twist in early 2023 [48] Question: What is the outlook for joint preservation growth? - Management expressed optimism about the joint preservation business, attributing current growth limitations to supply chain issues and indicating strong demand for X-Twist [51] Question: Is there a timetable for meeting with the FDA regarding CINGAL? - Management expects to meet with the FDA in the next few months to discuss the data package for CINGAL [58] Question: Are there mitigation efforts for supply chain issues? - Management confirmed that they are actively working to manage supply chain issues and are confident in meeting demand for the full launch of X-Twist [60] Question: What is the long-term growth outlook for joint preservation? - Management believes that joint preservation can achieve double-digit growth in the long term, supported by new product launches and market opportunities [63]
Anika Therapeutics(ANIK) - 2022 Q3 - Quarterly Report
2022-11-08 16:00
[Part I Financial Information](index=3&type=section&id=Part%20I%20Financial%20Information) This section details the unaudited condensed consolidated financial statements and management's analysis of financial condition and operations [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) The unaudited condensed consolidated financial statements for the period ended September 30, 2022, show a net loss primarily due to increased operating expenses, despite modest revenue growth, resulting in decreased cash and cash equivalents [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2022, total assets marginally increased to $347.7 million, while cash and cash equivalents decreased, and total liabilities rose due to higher lease liabilities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $87,777 | $94,386 | | Total current assets | $167,761 | $168,528 | | Total assets | $347,746 | $347,535 | | **Liabilities & Equity** | | | | Total current liabilities | $26,352 | $29,795 | | Total liabilities | $62,809 | $58,050 | | Total stockholders' equity | $284,937 | $287,085 | [Consolidated Statements of Operations and Comprehensive Income](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income) The company reported a net loss for both the third quarter and nine-month period of 2022, primarily due to increased operating expenses and the absence of a significant gain from contingent consideration recognized in the prior year Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $40,264 | $39,536 | $116,614 | $111,973 | | Gross Profit | $22,779 | $23,023 | $69,445 | $64,809 | | (Loss) income from operations | $(5,798) | $1,300 | $(12,733) | $11,738 | | Net (loss) income | $(4,175) | $558 | $(9,951) | $9,927 | | Diluted (loss) income per share | $(0.29) | $0.04 | $(0.68) | $0.68 | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities remained stable, but increased investing activities and financing outflows led to an overall decrease in cash and cash equivalents for the nine-month period Consolidated Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash provided by operating activities | $3,928 | $3,925 | | Net cash used in investing activities | $(4,957) | $(1,878) | | Net cash used in financing activities | $(5,519) | $(6,839) | | **Decrease in cash and cash equivalents** | **$(6,609)** | **$(4,841)** | [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) These notes detail the company's business, acquisitions, and revenue recognition, highlighting the final contingent consideration payment, segment revenue contributions, and significant customer concentration - The company is a global joint preservation company that expanded its platform through the 2020 acquisitions of Parcus Medical and Arthrosurface[19](index=19&type=chunk)[20](index=20&type=chunk) - In Q3 2022, the company paid the final contingent consideration of **$4.3 million** related to the Parcus Medical acquisition. As of September 30, 2022, the contingent consideration liability for all acquisitions is **zero**[30](index=30&type=chunk)[48](index=48&type=chunk) Revenue by Product Family (in thousands) | Product Family | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | OA Pain Management | $25,665 | $26,153 | $74,139 | $69,790 | | Joint Preservation and Restoration | $11,821 | $11,193 | $36,055 | $35,296 | | Non-Orthopedics | $2,778 | $2,190 | $6,420 | $6,887 | | **Total** | **$40,264** | **$39,536** | **$116,614** | **$111,973** | - A single customer, DePuy Synthes Mitek Sports Medicine (Mitek), accounted for **45%** of total revenue for the three months ended September 30, 2022, down from **51%** in the prior-year period[63](index=63&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transformation, ongoing COVID-19 challenges, and the Q3 2022 net loss driven by increased operating expenses and declining gross margin, alongside a decrease in non-GAAP adjusted EBITDA and net income [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Q3 2022 revenue increased by 2%, but a decline in gross margin due to inventory reserves and a 22% rise in SG&A expenses, coupled with the absence of a prior-year gain, resulted in a net loss Revenue by Product Family - Q3 YoY Change (in thousands) | Product Family | Q3 2022 | Q3 2021 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | OA Pain Management | $25,665 | $26,153 | $(488) | (2%) | | Joint Preservation and Restoration | $11,821 | $11,193 | $628 | 6% | | Non-Orthopedic | $2,778 | $2,190 | $588 | 27% | | **Total** | **$40,264** | **$39,536** | **$728** | **2%** | - Gross profit decreased slightly in Q3 2022, with gross margin falling to **57%** from **58%** in Q3 2021. The decline was primarily due to a **$2.6 million** inventory reserve for certain legacy Non-Orthopedic products[116](index=116&type=chunk)[117](index=117&type=chunk) - SG&A expenses increased by **$3.8 million (22%)** in Q3 2022 compared to Q3 2021, driven by the expansion of U.S. commercial capabilities, increased marketing activities, and higher stock-based compensation[119](index=119&type=chunk) - The company reported a net loss of **$4.2 million** in Q3 2022, a significant decrease from the **$0.6 million** net income in Q3 2021. This was primarily due to the absence of a **$3.5 million** gain from the change in fair value of contingent consideration recorded in Q3 2021 and higher operating expenses[120](index=120&type=chunk)[123](index=123&type=chunk) [Non-GAAP Financial Measures](index=28&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP metrics show an increase in Adjusted Gross Margin but a decrease in Adjusted EBITDA and a shift to Adjusted Net Loss in Q3 2022, driven by higher manufacturing costs and increased commercial spending Reconciliation of Net (Loss) Income to Adjusted EBITDA (in thousands) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Net (loss) income | $(4,175) | $558 | $(9,951) | $9,927 | | Adjustments... | ... | ... | ... | ... | | **Adjusted EBITDA** | **$4,050** | **$5,747** | **$10,746** | **$16,631** | Reconciliation of Net (Loss) Income to Adjusted Net (Loss) Income (in thousands) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Net (loss) income | $(4,175) | $558 | $(9,951) | $9,927 | | Adjustments... | ... | ... | ... | ... | | **Adjusted net (loss) income** | **$(725)** | **$774** | **$(4,044)** | **$2,889** | [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and cash equivalents decreased to $87.8 million, while working capital remained strong at $141.4 million, with an undrawn $75.0 million revolving line of credit available - Cash, cash equivalents, and investments totaled **$87.8 million** at September 30, 2022, a decrease from **$94.4 million** at December 31, 2021[140](index=140&type=chunk) - The company has a **$75.0 million** senior revolving line of credit with no outstanding borrowings as of September 30, 2022[142](index=142&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes to its market risks or the management of such risks since its Annual Report on Form 10-K for the year ended December 31, 2021 - There have been no material changes in the first nine months of 2022 to the company's market risks or its management of such risks[153](index=153&type=chunk) [Item 4. Controls and Procedures](index=33&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 September 30, 2022 - The CEO and CFO concluded that the company's disclosure controls and procedures are **effective**[155](index=155&type=chunk) - No material changes were made to the internal control over financial reporting during the quarter ended September 30, 2022[156](index=156&type=chunk) [Part II Other Information](index=35&type=section&id=Part%20II%20Other%20Information) This section presents other information including legal proceedings, risk factors, equity sales, and a list of exhibits [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material changes to the legal proceedings disclosed in its 2021 Annual Report - There have been no material changes to the information on legal proceedings since the 2021 Form 10-K[158](index=158&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company highlights key risk factors including inflation, reliance on limited suppliers, and ongoing supply chain disruptions, which have impacted revenue and are expected to continue - Inflation is identified as a risk that could increase overall costs and potentially curtail elective orthopedic procedures[160](index=160&type=chunk) - The company relies on a small number of suppliers for key raw materials, including a single third-party contract manufacturer for bone preserving joint technologies, creating a risk of supply interruption[161](index=161&type=chunk)[162](index=162&type=chunk) - Global supply chain challenges related to COVID-19 have caused disruptions and are expected to continue, potentially impacting the company's ability to generate revenue. These disruptions impacted revenue during the first nine months of 2022[163](index=163&type=chunk)[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company has a share repurchase program with $20.0 million remaining for open market repurchases - The company has a **$50.0 million** share repurchase program with **$20.0 million** remaining available for open market repurchases[167](index=167&type=chunk) - No open market repurchases were made during the nine-month period ended September 30, 2022[167](index=167&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the CEO and CFO and interactive data files (XBRL)
Anika Therapeutics(ANIK) - 2022 Q2 - Earnings Call Transcript
2022-08-06 08:40
Anika Therapeutics, Inc. (NASDAQ:ANIK) Q2 2022 Earnings Conference Call August 3, 2022 5:00 PM ET Company Participants Mark Namaroff - Vice President, Investor Relations, ESG and Corporate Communications Cheryl Blanchard - President and Chief Executive Officer Michael Levitz - Executive Vice President, Chief Financial Officer and Treasurer Conference Call Participants James Sidoti - Sidoti & Company Michael Petusky - Barrington Research Operator Good evening, ladies and gentlemen, and welcome to Anika's Sec ...
Anika Therapeutics(ANIK) - 2022 Q2 - Earnings Call Presentation
2022-08-06 07:09
Financial Performance - Total revenue increased by 4% to $39.7 million[29] - OA Pain Management revenue increased by 6% to $25.7 million[29] - Joint Preservation and Restoration revenue increased by 2% to $12.1 million[29] - Non-Orthopedic revenue decreased by 6% to $1.8 million[29] - Gross margin was 63%, including $1.6 million of non-cash acquisition-related expenses; adjusted gross margin was 67%[29] - Net loss was ($2.8) million, or ($0.20) per share; adjusted net loss was ($1.6) million, or ($0.12) per share[29] - Adjusted EBITDA was $4.4 million[29] - Cash balance as of June 30, 2022, was $91.4 million[29] Business Highlights - Received 510(k) clearance for X-Twist™ fixation system, with limited market release planned for 2H 2022[5] - Continuing to ramp up Joint Preservation medical education activities, with 270 surgeons trained YTD[5] - Tactoset® received an ACE award for innovation at the American Orthopaedic Society for Sports Medicine (AOSSM) meeting[5] - Completed last patient follow-up in Cingal® pilot study, with data read-out planned for Fall 2022[5]
Anika Therapeutics(ANIK) - 2022 Q1 - Earnings Call Transcript
2022-05-07 10:36
Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $36.7 million, an increase of 7% compared to the prior year [21] - Gross margin was 59%, with an adjusted gross margin of 64% after excluding noncash acquisition-related expenses [22] - Net loss for the quarter was $2.9 million, or $0.20 per share, compared to net income of $2.8 million, or $0.20 per diluted share in Q1 2021 [23] - Adjusted EBITDA was $2.6 million, down from $4.8 million in the same quarter last year [24] Business Line Data and Key Metrics Changes - OA pain management revenue increased by 18% to $22.7 million, driven by favorable order timing [21] - Joint preservation and restoration revenue decreased by 1% from $12.2 million to $12.1 million, showing some recovery after early quarter COVID headwinds [22] - Nonorthopedic revenue was $1.8 million, down 34% from the previous year due to higher revenues from last time buys of legacy products [22] Market Data and Key Metrics Changes - The company noted that the macroeconomic effects of staffing shortages and supply chain issues could remain as headwinds for the industry [10] - The healthcare environment appears to be improving, which is expected to positively impact market conditions [42] Company Strategy and Development Direction - The company is focused on becoming a leading provider of early intervention and joint preservation solutions, with several new product launches planned in the shoulder and foot and ankle spaces within the next six to 24 months [14][20] - The addition of Rob Delp as Vice President of U.S. Sales is expected to enhance commercial strategy execution [13] - The company aims for mid-teens revenue growth and an adjusted gross margin of 70% over the long term, despite being behind its original five-year target due to COVID impacts [28] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism for market improvement through the year as COVID-related impacts abate [10] - The company reiterated its full-year 2022 total revenue outlook of low to mid-single-digit percentage growth over 2021, with expectations for joint preservation and restoration to be the fastest-growing product family [25][26] - Adjusted EBITDA margin is expected to be in the low to mid-single digits due to targeted spending investments and ongoing supply chain challenges [28] Other Important Information - The company has ramped up medical education efforts, training over 140 surgeons to date [11] - The company is investing in commercial capabilities and product development to support growth objectives [27] Q&A Session Summary Question: Inquiry about OA pain management growth assumptions - Management indicated that the OA pain management market is expected to grow at about 1%, with the company aiming to grow ahead of the market [33] Question: Update on CINGAL pilot trial timeline - Management confirmed that data readout for the CINGAL pilot trial is expected in the fall, with updates to be provided at that time [36] Question: Clarification on OA pain management business strength - Management noted that the strong performance was due to favorable timing in international markets and veterinary products, but they did not change their full-year guidance [38] Question: Joint preservation revenue decline and future expectations - Management acknowledged a tough January due to Omicron but expects recovery and growth catalysts to drive improvement in the coming quarters [41]
Anika Therapeutics(ANIK) - 2022 Q1 - Earnings Call Presentation
2022-05-06 16:46
Financial Performance - Total revenue increased by 7% to $36.7 million[32] - OA Pain Management revenue increased by 18% to $22.7 million, primarily due to favorable order timing[32] - Joint Preservation and Restoration revenue decreased by 1% to $12.1 million due to early quarter COVID headwinds[32] - Non-Orthopedic revenue decreased by 34% to $1.8 million due to last time buys in Q1'21[32] - Gross margin was 59%, including $1.6 million of non-cash acquisition related expenses; Adjusted gross margin was 64%[32] - Net loss was ($2.9) million, or ($0.20) per share; Adjusted net loss was ($1.6) million, or ($0.11) per share[32] - Adjusted EBITDA was $2.6 million[32] - The company's cash balance as of March 31, 2022, was $90.3 million[32] Strategic Focus - Anika is focused on becoming the leader in joint preservation[44] - 2022 is a foundational year for executing on the product pipeline and commercial strategy to deliver targeted value to Ambulatory Surgery Centers (ASC)[44] - The company aims to emerge with a broad, differentiated product portfolio and a commercial team focused on the joint preservation continuum of care[44] Future Growth - The company is positioning to accelerate revenue growth coming out of 2022, growing both EBITDA margin and cash flows[44] - The company is targeting adjusted gross margin of 70%+ and adjusted EBITDA margin of 20%+ with $230M+ revenue on mid-teens CAGR[42]