Nicox to Present at the H.C. Wainwright Virtual BioConnect Conference

On January 7, 2021 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported that Michele Garufi, Chairman and Chief Executive Officer of Nicox, will present in a fireside chat at the H.C. Wainwright BioConnect Conference being held virtually on January 11-14, 2021 (Press release, NicOx, JAN 7, 2021, https://www.nicox.com/news-media/nicox-to-present-at-the-h-c-wainwright-virtual-bioconnect-conference/ [SID1234573630]).

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A video webcast of Nicox’s presentation will be available on-demand from Monday January 11 at 6:00 a.m. EST for one week by clicking here and accessible on Nicox’s website (www.nicox.com) in the "Presentations & Events" section. The video webcast will be available for 90 days.

AngioDynamics Reports Fiscal 2021 Second Quarter Financial Results

On January 7, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the second quarter of fiscal year 2021, which ended November 30, 2020 (Press release, AngioDynamics, JAN 7, 2021, View Source [SID1234573652]).

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"I am very pleased with our performance in the second quarter, as sales execution and continued expense management drove strong revenue and positive earnings," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "AngioVac and Auryon performed well during the quarter, as we continue to focus on growing our key technology platforms while managing expenses throughout the business. In the second half of the year, we expect ongoing COVID-related headwinds as well as typical third-quarter seasonality, which is contemplated in our full-year guidance. We are excited about the planned launch of our multi-purpose mechanical aspiration thrombectomy device in calendar 2021, as this new member of the AngioVac platform family will position us to serve the much larger addressable market of moderately complex thrombectomy cases, while AngioVac and Uni-Fuse continue to address the complex and simple ends of the spectrum, respectively."

Second Quarter 2021 Financial Results

Net sales for the second quarter of fiscal 2021 were $72.8 million, an increase of 4.0% compared to the prior-year quarter. Net sales in the second quarter continued to be impacted by the disruption to procedure volumes resulting from the COVID-19 global pandemic. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Vascular Interventions and Therapies ("VIT") net sales were $33.9 million, an increase of 8.8%, compared to $31.2 million a year ago. Growth was driven by increased AngioVac sales over the previous year, partially offset by a decline in sales of Venous products resulting from lower elective procedure volumes. Auryon sales during the quarter were $2.1 million.
Oncology net sales were $14.9 million, a decrease of 7.0% from $16.0 million a year ago. The year-over-year decline was primarily attributable to lower capital sales, which were somewhat offset by strong growth in sales of NanoKnife disposables, particularly in the United States.
Vascular Access net sales were $23.9 million, an increase of 5.0% from $22.8 million a year ago.
U.S. net sales in the second quarter of fiscal 2021 were $60.7 million, an increase of 9.2% from $55.6 million a year ago. International net sales were $12.1 million in the second quarter of fiscal 2021, a decrease of 16.3% from $14.4 million a year ago.

Gross margin for the second quarter of fiscal 2021 was 55.2%, a decline of 410 basis points compared to the second quarter of fiscal 2020. The gross margin decline was primarily attributable to the Company’s previously discussed COVID-related operating plan. This plan included under-absorption of the Company’s manufacturing facilities related to additional COVID-related operating protocols designed to ensure supply-chain security and employee safety. Additionally, during the second quarter, inventory was reduced by $3.2 million when compared to inventory levels on August 31, 2020. Since year end, inventory levels have been reduced by $10.3 million.

The Company recorded a net loss of $4.3 million, or loss per share of $0.11, in the second quarter of fiscal 2021. This compares to net loss of approximately $2.7 million, or loss per share of $0.07, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the second quarter of fiscal 2021 was $0.6 million or adjusted earnings of $0.01 per share, compared to adjusted net income of $2.2 million, or adjusted earnings per share of $0.06, in the second quarter of fiscal 2020.

Adjusted EBITDA in the second quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $5.2 million, compared to $6.4 million in the second quarter of fiscal 2020.

In the second quarter of fiscal 2021, the Company generated $11.5 million in operating cash and had capital expenditures of $1.4 million. As of November 30, 2020, the Company had $58.0 million in cash and cash equivalents compared to $47.9 million in cash and cash equivalents on August 31, 2020. As of November 30, 2020, the Company had $40.0 million in debt outstanding, consistent with its debt balance on August 31, 2020. Subsequent to quarter end, the Company repaid $10 million of its outstanding debt. Management remains focused on cash preservation amid the current environment.

Six Months Financial Results

For the six months ended November 30, 2020:

Net sales were $143.0 million, an increase of 5.1%, compared to $136.0 million for the same period a year ago.
The Company’s net loss was $9.0 million, or a loss of $0.22 per share, compared to a net loss of $4.0 million, or a loss of $0.11 per share, a year ago.
Gross margin decreased 550 basis points to 53.1% from 58.6% a year ago due to the Company’s previously discussed COVID-related operating plan.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.2 million, or $0.03 per share, compared to adjusted net income of $5.3 million, or $0.14 per share, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $9.6 million, compared to $13.7 million for the same period a year ago.
Fiscal Year 2021 Financial Guidance

The Company continues to expect fiscal year 2021 net sales in the range of $278 to $284 million and fiscal year 2021 adjusted earnings per share in the range of $0.00 to $0.05.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2021 second quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13714154.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, January 7, 2021, until 11:59 p.m. ET on Thursday, January 14, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13714154.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

TLC to Attend 39th Annual JP Morgan Healthcare Conference

On January 7, 2021 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, reported that it has been invited to attend the 39th annual JP Morgan Healthcare Conference, scheduled to take place January 10-14, 2021 (Press release, Taiwan Liposome Company, JAN 7, 2021, View Source [SID1234573669]).

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JP Morgan Healthcare Conference has been and is the largest and most information healthcare investment symposium in the industry, with attendance of over 8,000 participants each year. This year, the conference will be conducted entirely virtually over the internet instead of physically taking place at the Westin St. Francis Hotel in San Francisco as per tradition, in an effort to impede the spread of COVID-19.

TLC will be attending the conference for the seventh year in a row at the invitation-only event. Members of TLC’s management team will provide updates on the status of the Company’s innovative product candidates, including TLC599 and TLC590, which are non-opioids with the potential to provide extended relief of osteoarthritis pain and postsurgical pain, respectively.

Infinity Pharmaceuticals Provides Update for Eganelisib in Patients with Metastatic Urothelial Cancer

On January 6, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported an update on MARIO-275, the Company’s randomized, placebo controlled Phase 2 study evaluating the benefit of adding eganelisib to nivolumab (Opdivo) in platinum-refractory, I/O naïve patients with advanced, metastatic urothelial cancer (mUC) over nivolumab monotherapy which is approved in this setting (Press release, Infinity Pharmaceuticals, JAN 6, 2021, View Source [SID1234573541]).

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"The MARIO-275 study provided Infinity with important insights to shape the future of eganelisib in urothelial cancer," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "The data from the 49 patients enrolled in the study are very encouraging. The combination was well tolerated at the 30 mg dose of eganelisib and provided patient benefit relative to the placebo controlled arm on important response rate and progression free survival measures, particularly in urothelial cancer patients with low levels of PD-L1 expression who respond poorly to checkpoint inhibitors alone. We are leveraging the clinical and translational learnings from MARIO-275 in planning a new, registration-enabling study of eganelisib in patients with advanced urothelial cancer. We look forward to presenting our data from MARIO-275, which support our clinical strategy, at a major medical meeting in Q1 2021, with details for our new, planned trial to follow in the coming months after discussions with regulatory authorities."

Encouraging data including in post-CPI progression and PD-L1 low patients was presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November and the San Antonio Breast Cancer Symposium (SABCS) in Q4 2020.

Program Updates and Guidance:

MARIO-275

The MARIO-275 Independent Data Monitoring Committee (IDMC) determined that there was a favorable risk/benefit for patients after the successful implementation of a dose reduction from 40mg QD to 30mg QD to reduce the reversible liver enzyme elevations that were reported after the first scheduled MARIO-275 IDMC meeting.
Infinity has completed the evaluation of the 49 patients enrolled in the study with encouraging safety, response rate and progression free survival (PFS) data, including in patients with low levels of PD-L1 expression.
Infinity will be presenting the MARIO-275 data at a major medical meeting in Q1 2021.
As a result of the encouraging data, the Company is planning a new registration-enabling study and will not re-open enrollment in MARIO-275.
MARIO-3

Data was presented at SABCS in December which showed the benefit of adding eganelisib to standard of care Tecentriq and Abraxane therapy for front-line TNBC patients.
Progression-free survival and updated overall response rate data for TNBC will be presented in 1H and 2H of 2021.
Renal cell carcinoma data to be presented in 1H 2022.
2021 Financial Guidance

Infinity ended 2020 with approximately $34.1 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2020 financial results in March. The Company expects to have cash through 2021 based on its current operating plans, which excludes additional financing or business activities, and excludes a potential $5 million milestone payment from BVF for positive Phase 3 patidegib data and any milestones from, or the sale of the Company’s equity interest in, PellePharm.

PACIRA BIOSCIENCES TO PRESENT AT THE 39TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

On January 6, 2021 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will present at the 39th Annual J.P. Morgan Healthcare Conference at 7:30 AM ET on Wednesday, January 13, 2021 (Press release, Pacira Pharmaceuticals, JAN 6, 2021, View Source [SID1234573561]). Live audio of the virtual event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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