On August 5, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the second quarter ended June 30, 2021, and provided a corporate update (Press release, Lipocine, AUG 5, 2021, View Source [SID1234586034]).

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Recent Corporate Highlights

Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects
36-week biopsy data from the LiFT clinical study are expected in August 2021
Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144
Clinical data from the LiFT clinical study were presented at The International Liver Congress 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, which took place June 23-26, 2021
Results from the LiFT clinical study showed that LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects
Data from the LiFT clinical study showed high prevalence of low normal or overtly hypogonadal levels of testosterone in histologically established NASH subjects
LPCN 1144 was shown to improve body composition in biopsy-confirmed NASH patients
The U.S. Food and Drug Administration ("FDA") cleared the Company’s Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults
Top-line results from an ongoing pharmacokinetic ("PK") study to assess dose proportionality are expected in the third quarter of 2021
Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to begin in the fourth quarter of 2021
Entered into a global settlement agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between Lipocine and Clarus, as well as the on-going interference proceeding between the two companies
Continued business development activities surrounding TLANDO related to the commercialization of TLANDO upon approval by the FDA
Expect the first subject will be dosed in the proof-of-concept Phase 2 study in male cirrhotic subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhotic subjects in the fourth quarter of 2021
Second Quarter Ended June 30, 2021 Financial Results
Lipocine reported a net loss of $6.8 million, or ($0.08) per diluted share, for the second quarter ended June 30, 2021, compared with a net loss of $6.4 million, or ($0.13) per diluted share, for the second quarter ended June 30, 2020.

Research and development expenses were $1.5 million for the second quarter ended June 30 2021, compared with $2.3 million for the second quarter ended June 30, 2020. The decrease was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a decrease in personnel expense, which was mainly due to a decrease in stock compensation and bonus expense. These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

General and administrative expenses were $1.5 million for the second quarter ended June 30, 2021, compared with $2.0 million for the second quarter ended June 30, 2020. The decrease in general and administrative was primarily related to a decrease in personnel costs, which was mainly due to a decrease in stock compensation and bonus expense, and a decrease in legal expenses. These decreases were offset by increases in corporate insurance and other general and administrative expenses.

As of June 30, 2021, the Company had $46.6 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

Six Months Ended June 30, 2021 Financial Results
Lipocine reported a net loss of $10.2 million, or ($0.12) per diluted share, for the six months ended June 30, 2021, compared with a net loss of $12.1 million, or ($0.27) per diluted share, for the six months ended June 30, 2020.

Research and development expenses were $3.0 million for the six months ended June 30, 2021, compared with $4.8 million for the six months ended June 30, 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a net decrease in personnel expense, which was mainly due to a decrease in stock compensation expense offset by increases in salaries. These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

General and administrative expenses were $3.1 million for the six months ended June 30, 2021, compared with $4.0 million for the six months ended June 30, 2020. The decrease in general and administrative expenses was primarily due to a decrease in legal costs and a decrease in personnel costs, mainly due a reduction in stock compensation expense. These decreases were offset by an increase in corporate insurance expenses and an increase in other general and administrative expenses.

On August 5, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-US) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Operating Officer, is scheduled to present at Canaccord Genuity 41st Annual Growth Conference on Wednesday, August 11, 2021 at 3:00 pm ET, that will be held virtually (Press release, Knight Therapeutics, AUG 5, 2021, View Source [SID1234586050]). A copy of the investor presentation will be available at www.gud-knight.com.

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On August 5, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported its financial results for the second quarter of fiscal year 2021 (Press release, Certara, AUG 5, 2021, View Source [SID1234586604]).

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Highlights:
Revenue was $70.1 million, representing growth of 15% over the second quarter of 2020
Net loss was ($2.9) million, compared to a net income of $2.8 million in the second quarter of 2020
Adjusted EBITDA was $25.5 million, representing growth of 1% over the second quarter of 2020
Announced agreement to acquire Pinnacle 21, a leader in data standardization software for pharmaceutical clinical data, for $310 million in cash and stock, with a closing expected in early Q4 of 2021
Raised 2021 guidance from $283 million to $289 million of revenue, $101 million to $103 million of Adjusted EBITDA, and $0.21 to $0.25 of Adjusted Diluted Earnings Per Share. Updated guidance does not include the impact of the Pinnacle 21 acquisition
"Our second quarter results reflect continued momentum from increased adoption of our proprietary end-to-end platform and the launch of new software capabilities to expand use cases of biosimulation worldwide," said William F. Feehery, Chief Executive Officer of Certara. "Earlier today, we announced the strategic and accretive deal to acquire Pinnacle 21, our largest to date. This expansion of Certara’s quantitative tools and solutions will further help researchers and regulators answer critical questions throughout the drug development life cycle."

Second Quarter 2021 Results
"In the second quarter, Certara’s differentiated portfolio of software and technology-driven services delivered strong financial performance. Looking forward, we remain well-positioned to achieve our stated long-term goals of mid-teens revenue growth and Adjusted EBITDA margin expansion. With reported trailing twelve-month bookings growth of 26%, we have a high level of visibility towards realizing our business and financial plans for the year," said Andrew Schemick, Chief Financial Officer.

Total revenue for the second quarter of 2021 was $70.1 million, representing year-over-year growth of 15%. The revenue growth was driven by both technology-driven services and software licenses and subscriptions.

Total cost of revenue for the second quarter of 2021 was $27.5 million, an increase from $20.6 million in the second quarter of 2020, primarily due to a $3.9 million increase in employee related costs and a $1.4 million increase in stock-based compensation costs.

Total operating expenses for the second quarter of 2021 were $37.3 million, an increase from $26.9 million in the second quarter of 2020, primarily due to a $5.6 million increase in stock-based compensation expense and a $2.1 million increase in employee related costs. The remaining increases were due to increases in refinancing costs, acquisition related costs and D&O insurance costs.

Net loss for the second quarter of 2021 was ($2.9) million, compared to a net income of $2.8 million in the second quarter of 2020. The loss was primarily due to a $7.0 million increase in stock-based compensation expense.

Diluted Earnings Per Share for the second quarter 2021 were ($0.02), as compared to $0.02 in the second quarter of 2020.

Adjusted EBITDA for the second quarter of 2021 was $25.5 million compared to $25.3 million for the second quarter of 2020, representing 1% growth. Adjusted EBITDA for the second quarter of 2020 included the benefit of the completion of high margin projects and lower SG&A costs during the start of the pandemic, which when combined with public company costs incurred in 2021, led to a challenging comparison in the quarter. See note (1) in the section A Note on Non-GAAP Financial Measures, below, for more information on Adjusted EBITDA. Adjusted Net Income for the second quarter of 2021 was $5.6 million compared to $3.8 million for the second quarter of 2020. Adjusted Diluted Earnings Per Share for the second quarter 2021 was $0.03 compared to $0.02 for the second quarter of 2020. See note (2) in the section A Note on Non-GAAP Financial Measures, below, for more information on Adjusted Net Income and Adjusted Diluted Earnings Per Share.

2021 Financial Outlook
Certara is updating its previously reported guidance for full year 2021, not including the impact of the Pinnacle 21 acquisition, by raising the ranges for revenue, Adjusted EBITDA and Adjusted Diluted Earnings Per Share. We expect the following:

Full year 2021 revenue to be in the range of $283 million to $289 million;

Full year 2021 Adjusted EBITDA to be in the range of $101 million to $103 million;

Full year 2021 Adjusted Diluted Earnings Per Share is expected to be in the range of $0.21 to $0.25;

Fully diluted shares for 2021 will be 153 million to 155 million; and

Effective annual tax rate for 2021 will be in the range of 40% to 45%.

Webcast and Conference Call Details
Certara will host a conference call today, August 5, 2021, at 5:00 p.m. ET to discuss its second quarter 2021 financial results and the impact of the Pinnacle 21 acquisition. The dial-in numbers are (833) 360-0946 for domestic callers or (914) 987-7661 for international callers, followed by Conference ID: 2728807. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for approximately one year.

On August 5, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics, will present a Company overview during the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12th at 4:30 p.m. ET (Press release, Cytori Therapeutics, AUG 5, 2021, View Source [SID1234585800]).

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Investors interested in arranging a meeting with the Company’s management should contact the Canaccord Genuity conference coordinator.

A webcast of the conference presentation will be available under the ‘Events’ tab of the Investor Relations section of the Plus Therapeutics website at www.plustherapeutics.com.

On August 5, 2021 Kureha Corporation reported that it FY2021 1Q Results (Press release, Kureha Corporation, AUG 5, 2021, View Source [SID1234585847])

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Revenue recovered in Advanced Materials after the pandemic-related slump
• Higher core operating profit supported by Advanced Materials, Specialty Plastics and Other Operations
• Operating profit improved as a result of higher core operating profit
• Profit attributable to the Company increased as a result of higher profit before taxes

Advanced plastics Operating profit improved on higher sales volumes of PVDF, PPS and PGA: continued strong demand for PVDF binder in the automobile LiB market; enhanced production for PPS at a new facility; and PGA frac plugs sales steadily recovering in the post-pandemic shale oil and gas market Carbon products Operating profit remained flat despite higher sales volumes of carbon fiber insulation products for industrial high-heat furnacesAgrochemicals & Pharmaceuticals Sales volume growth of Kremezin, a therapeutic agent for chronic kidney failures, more than offset by a volume decline in agrochemical fungicides, together yielding lower operating profit Industrial chemicals Operating profit improved on higher sales volumes of organic chemicals

Home products / Fiber products Operating profit growth driven by higher ‘NEW Krewrap’ home products and ‘Seaguar’ fishing lines volumes Packaging materials Profit decreased due to higher raw materials cost despite improved revenue from heatshrink multilayer film, etc.

• The shale oil and gas market is gradually recovering as economic activity returns with rising oil prices
• Expanded the adaptation of PGA frac plugs in entire horizontal wells (full-bore use) at major customers by offering flexible volume price discounts since fall 2020
• Continues to promote the full-bore use and expand Kureha’s market share in high-/mid-temperature oilfields via flexible pricing and product design improvements, while developing improved PGA frac plugs for very low-temperature wells
• Aims to generate profit in the PGA business in FY2023 0 25 50 75 LiB binder application Other applications
• Robust PVDF sales continues on strong demand in the automobile LiB market since 3Q FY2020, driven by nations’ environment initiatives and subsidy policies promoting electric vehicles • Price negotiations underway to reflect rising raw materials cost
• Plans to increase the production of PVDF binder for automobile LiB applications at the Iwaki Factory, starting from February 2022
• Announces the decision to build a new PVDF plant (10,000tps) in Changshu, China on July 20, 2021