On July 28, 2021 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2021 and provided updated financial expectations for full-year 2021 (Press release, Alkermes, JUL 28, 2021, View Source [SID1234585269]).

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"Alkermes’ strong performance in the second quarter was driven by commercial execution and our focus on profitability. VIVITROL and ARISTADA demonstrated robust sequential and year-over-year growth and VUMERITY continued on an encouraging launch trajectory," commented Iain Brown, Chief Financial Officer of Alkermes. "Today, we are raising our financial expectations for full-year 2021 to reflect this performance and anticipated continued strength in the business. We believe that we are in a sound financial position to execute on our business strategy and efficiently invest in our future potential growth drivers."

Quarter Ended June 30, 2021 Financial Results

Revenues

Total revenues for the quarter were $303.7 million. This compared to $247.5 million for the same period in the prior year.
Net sales of proprietary products for the quarter were $160.8 million, compared to $130.4 million for the same period in the prior year.
Net sales of VIVITROL were $88.4 million, compared to $71.6 million for the same period in the prior year, representing an increase of approximately 23%.
Net sales of ARISTADAi were $72.4 million, compared to $58.8 million for the same period in the prior year, representing an increase of approximately 23%.
Manufacturing and royalty revenues for the quarter were $142.3 million, compared to $116.5 million for the same period in the prior year.
Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $95.5 million, compared to $83.1 million for the same period in the prior year.
Manufacturing and royalty revenues from VUMERITY were $20.3 million, compared to $2.6 million for the same period in the prior year.
Costs and Expenses

Total operating expenses for the quarter were $299.3 million, compared to $281.2 million for the same period in the prior year.
Cost of Goods Manufactured and Sold were $53.1 million, compared to $45.1 million for the same period in the prior year.
Research and Development (R&D) expenses were $97.5 million, compared to $94.2 million for the same period in the prior year.
Selling, General and Administrative (SG&A) expenses were $139.2 million, compared to $132.0 million for the same period in the prior year.
Profitability

Net income according to generally accepted accounting principles in the U.S. (GAAP) was $2.4 million for the quarter, or a basic and diluted GAAP earnings per share of $0.01. This compared to GAAP net loss of $29.4 million, or a basic and diluted GAAP loss per share of $0.19, for the same period in the prior year.
Non-GAAP net income was $49.2 million for the quarter, or a non-GAAP basic earnings per share of $0.31 and a non-GAAP diluted earnings per share of $0.30. This compared to non-GAAP net income of $8.9 million, or a non-GAAP basic and diluted earnings per share of $0.06 for the same period in the prior year.
Balance Sheet

At June 30, 2021, the company recorded cash, cash equivalents and total investments of $669.4 million, compared to $627.4 million at March 31, 2021, driven primarily by the company’s operating results and changes in working capital. The company’s total debt outstanding as of June 30, 2021 was $297.1 million.
Financial Expectations for 2021

The following financial expectations for 2021 are based on recent trends and assume continued improvement in patient access to treatment providers and to the company’s commercial products in the second half of the year. If patient access does not improve as anticipated, or if new COVID-19-related disruptions emerge, the company’s ability to meet these expectations could be negatively impacted. All line items are according to GAAP, except as otherwise noted.

*R&D expense expectations for 2021 include an anticipated $25 million milestone payment in the third quarter to the former shareholders of Rodin Therapeutics, Inc. related to the expected submission of an investigational new drug application, or equivalent, for ALKS 1140, the first clinical candidate to emerge from the histone deacetylase (HDAC) inhibitor platform acquired by the company in late 2019.

+ The current 2021 per share expectations are calculated based on a weighted average basic share count of approximately 161 million shares outstanding and a weighted average diluted share count of approximately 164 million shares outstanding, as compared to prior expectations of approximately 160 million and 161 million, respectively.

"Our achievements in the second quarter demonstrated continued execution against our strategic priorities. Our strong commercial performance, the FDA approval of LYBALVI and the accumulating data and operational progress in our nemvaleukin immuno-oncology program represent important milestones for the company and provide a meaningful platform to drive future growth," said Richard Pops, Chief Executive Officer of Alkermes. "Guided by our intense focus on value creation, our objectives for the remainder of 2021 are clear: successfully launch LYBALVI; drive the growth of VIVITROL and ARISTADA; advance the clinical development program for nemvaleukin; and invest in our emerging neuroscience and oncology pipeline assets."

Recent Events:

Psychiatry

In June 2021, the company announced FDA approval of LYBALVI (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproateii. LYBALVI is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, co-formulated with samidorphan, a new chemical entity, in a single bilayer tablet.
Nemvaleukin alfa ("nemvaleukin")

In June 2021, the company presented updated data from the ARTISTRY clinical development program for nemvaleukin, the company’s novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In conjunction with the data presentation at ASCO (Free ASCO Whitepaper), the company hosted an investor webcast with ARTISTRY clinical program investigators Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator at START Madrid at Centro Integral Oncológico Clara Campal and Omid Hamid, M.D., Chief of Research and Immunotherapy at The Angeles Clinic and Research Institute.
Corporate

In May 2021, the company announced the appointment of Emily Peterson Alva to the company’s Board of Directors (the Board). Ms. Alva is an experienced public company board member and a financial, strategic and business advisor to growth companies. Ms. Alva is the fifth new, independent director to join the Board in the past two years.
In July 2021, the company awarded grants from its Alkermes Inspiration Grants program to 11 nonprofit organizations working to address the needs of people living with addiction, serious mental illness or cancer.
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 28, 2021, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

On July 28, 2021 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that it will report financial results and provide a business update for the second quarter ended June 30, 2021, after the US markets close on Monday, August 9, 2021 (Press release, Adaptimmune, JUL 28, 2021, View Source [SID1234585268]). Following the announcement, the Company will host a live teleconference and webcast at 4:30 p.m. EDT (9:30 p.m. BST) that same day (details below).

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The press release will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/3zFas59.

To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (7867634).

On July 28, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will report second quarter 2021 financial results on Wednesday, August 4, 2021, prior to the open of the market (Press release, UroGen Pharma, JUL 28, 2021, View Source [SID1234585264]). The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Audio Webcast

The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On July 28, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held on Monday, August 2, 2021 at 8:30 AM ET to discuss results for the second quarter 2021 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, JUL 28, 2021, https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-second-quarter-2021 [SID1234585262]). Michael S. Weiss, Chairman and Chief Executive Officer, will host the call.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On July 28, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported financial results for the fiscal year ended March 31, 2021 (Press release, Portage Biotech, JUL 28, 2021, View Source [SID1234585260]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Over the past year, we’ve transformed Portage, positioning the Company to capitalize on our promising portfolio of immuno-oncology platforms and assets as well as leverage our innovative drug development engine," said Dr. Ian Walters, chief executive officer of Portage Biotech. "Throughout this transformation, we’ve maintained efficiency in our capital expenditures and operations to maximize value for shareholders thanks to the support of our lean, experienced team. Our efficiency coupled with our recent financing provides us with sufficient cash runway to complete Phase 1 and Phase 2 clinical trials for our lead invariant natural killer T cell (iNKT) agonists and is our first with formal biotech institutional support. We believe iNKTs have the potential to re-sensitize PD-1 tumors and could significantly expand the PD-1 market opportunity. With sufficient resources now in place, we are poised to advance our iNKT agonists and other assets through multiple data milestones and other value-driving catalysts in the coming year."

Financial & Business Highlights from FY 2021 (April 2020 – March 2021) and Recent Weeks

Increased financial resources with over $29 million raised since fiscal year end:
Successful public offering of 1,150,000 ordinary shares with gross proceeds of $26.5 million, securing a 2-year cash runway sufficient to advance programs and enable achievement of numerous milestones.
Generation of an additional $2.6 million through the sale of approximately 91,000 shares via the Company’s At-the-Market offering as of June 7, 2021.
Improved stock liquidity:
Listing of common shares on the NASDAQ exchange and subsequent voluntary delisting from the Canadian Securities Exchange.
Inclusion in the Russell 2000 Index, bringing added visibility to the Company’s robust immuno-oncology pipeline.
Immuno-oncology focused: Divestiture of three legacy businesses (Portage Pharmaceuticals Limited, including subsidiaries Portage Glasgow Ltd. and EyGen Ltd) to Juvenescence Ltd. Through this divestiture, Portage may be entitled to share in revenues upon the achievement of certain milestones based on specified development criteria and may be eligible to receive potential royalties on net sales of products developed utilizing legacy intellectual property.
Clinical Highlights from FY 2021 (April 2020 – March 2021) and Recent Weeks

Acceleration of development programs from the Company’s first-in-class immuno-oncology asset portfolio, including milestones related to lead iNKT agonists PORT-2 and PORT-3 and intratumoral amphiphilic therapy PORT-1. Key milestones included:
Initiation of the PRECIOUS-01 Study of PORT-3 for the treatment of NY-ESO-1 positive solid tumors, the first in a comprehensive clinical development plan to evaluate the Company’s iNKT agonists (PORT-2 and PORT-3) to improve outcomes in a variety of solid tumors.
Initiation of the INVINCIBLE Trial, a Phase 2 early-stage breast cancer study of INT230-6 (PORT-1) conducted by Intensity Therapeutics.
Presentation of interim data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference from the IT-01 Phase 2 trial conducted by Intensity Therapeutics demonstrating strong safety and survival data for INT230-6 (PORT-1) as both a monotherapy and in combination with pembrolizumab or ipilimumab in solid tumors.
Financial Results FY 2021 (April 2020 – March 2021)

The Company generated a net loss of $17.2 million in fiscal year 2021, compared to a net loss of $7.2 million in fiscal year 2020, an increase in net loss of $10.0 million year over year. Operating expenses, which include research and development and general and administrative expenses, were $12.4 million in fiscal year 2021, compared to $6.0 million in fiscal year 2020, an increase of $6.4 million. Operating expenses included $8.8 million of non-cash stock-based compensation expense in fiscal year 2021, compared to $2.1 million in fiscal year 2020.

Research and development ("R&D") costs increased by $3.2 million, or approximately 78%, from $4.1 million in fiscal year 2020, to $7.3 million in fiscal year 2021. The increase was attributable to non-cash stock-based compensation expense associated with grants made under the 2021 Equity Incentive Plan of $5.1 million, partially offset by a decrease in iOx related stock-based compensation expense of $0.8 million. Finally, fiscal 2021 development was slowed by the impact of the pandemic.

General and administrative ("G&A") expenses increased by $3.2 million, from $1.9 million in fiscal year 2020, to $5.1 million in fiscal year 2021. The principal reason for the increase was the $2.8 million of non-cash stock-based compensation expense associated with the Company’s 2021 Equity Incentive Plan in fiscal 2021. Additionally, the Company incurred approximately $0.2 million relating to initiatives associated with a corporate restructuring and business development.

Other items of income and expense were substantially non-operating in nature and were $2.5 million net expense in fiscal year 2021, compared to $0.5 million net expense in fiscal year 2020. $2.0 million of the net expense in fiscal year 2021 was non-cash. Other items of income and expense included:

A loss on equity issued at a discount of $1.3 million in fiscal year 2021, representing the difference between the market price and the contractual exercise price, relating to the settlement of the SalvaRx Notes and warrants;
A loss from our equity investment in Stimunity of $0.5 million, compared to a small gain in fiscal year 2020;
A loss of $0.8 million representing the change in the fair value of the warrants issued with respect to the SalvaRx settlement;
A non-cash gain relating to the settlement of related liabilities on the disposition of PPL of $0.4 million, of which $0.2 million was recorded in operations in fiscal year 2021; and
Interest expense of $0.2 million is fiscal year 2021, compared to $0.6 million in fiscal year 2020 due to the settlement of the SalvaRx Notes. The Company also recorded a loss of $0.2 million on the early extinguishment of the SalvaRx Notes in fiscal year 2021.
Additionally, the Company reflected net deferred income tax provisions of $2.3 million and $0.7 million in the fiscal years 2021 and 2020, respectively.

As of June 30, 2021, the Company had approximately $28.6 million of cash on hand.