On July 29, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that business highlights and financial results for the three months ended June 30, 2021 (Press release, Opko Health, JUL 29, 2021, View Source [SID1234585364]).

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Business Highlights

BioReference Laboratories (BRL) test volume increased 32% compared with the second quarter of 2020. During the second quarter of 2021, BRL processed approximately 2.8 million COVID-19 PCR tests and has current capacity to process more than 100,000 PCR tests per day. In addition, during the quarter BRL performed approximately 132,000 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity.

In June 2021, BRL announced a COVID-19 custom testing program for U.S.-based crew and guests who cruise with Royal Caribbean Group, helping provide a safe environment for travelers and crew members. In April 2021, BRL announced a COVID-19 testing agreement for players and staff, stadium employees and league staff for the 2021 Major League Baseball season and the renewal of a similar agreement for the 2021 Major League Soccer season and 2021-2022 National Football League season.

Also, BRL announced the appointment of Katherine Stueland as President and Chief Executive Officer of GeneDx, Inc., its global genomics subsidiary. Ms. Stueland joined GeneDx from Invitae Corporation, where she served most recently as Chief Commercial Officer.
Executed agreement with Nicoya Therapeutics for the development and commercialization of RAYALDEE in Greater China. OPKO entered into an agreement with Nicoya Macau Limited, an affiliate of Nicoya Therapeutics (Nicoya), for the development and commercialization in Greater China including mainland China, Hong Kong, Macau and Taiwan of RAYALDEE for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD). OPKO received an upfront payment of $5 million and is entitled to receive an additional $5 million payment upon the earlier of the 12-month anniversary of the agreement or Nicoya achieving a certain predetermined development milestone. In addition, OPKO will be eligible to receive up to $115 million upon the achievement of certain development, regulatory and sales-based milestones. Nicoya will pay OPKO tiered, double-digit royalties on product sales and will be responsible for regulatory approvals and commercial activities pertaining to RAYALDEE in their territory.
Executed exclusive worldwide agreement with CAMP4 Therapeutics Corporation (CAMP4) for the development, manufacture and commercialization of therapeutics utilizing the AntagoNAT technology. The AntagoNAT technology is an oligonucleotide platform developed under OPKO CURNA. CAMP4 has prioritized OPKO’s lead AntagoNAT compound to progress into clinical trials for the treatment of Dravet syndrome. Under the terms of the agreement, OPKO received an upfront cash payment and shares of privately held CAMP4. In addition, OPKO will be eligible to receive up to $93.5 million and additional shares upon the achievement of certain development and sales milestones for products developed from this technology and associated intellectual property. CAMP4 will also pay OPKO double-digit royalties on product sales.
Sale of sterile fill-and-finish manufacturing facility in Ireland. OPKO sold one of its facilities in Waterford, Ireland to Horizon Therapeutics plc for $65 million less certain assumed and accrued liabilities relating to transferred employees. The facility previously housed EirGen’s sterile fill-and-finish business.
Second Quarter Financial Results

Diagnostics: Revenue from services in the second quarter of 2021 increased to $397.2 million from $251.0 million in the prior-year period, primarily due to an increase in volume of COVID-19, clinical and genomic testing. Total costs and expenses were $367.2 million in the second quarter of 2021 compared with $216.2 million in the second quarter of 2020, resulting in operating income of $30.0 million compared with $40.9 million in the 2020 period. The decrease in operating income is primarily due to non-recurring benefits in the second quarter of 2020 including $10.9 million of revenue from the successful 4Kscore Medicare appeal and a $6.2 million grant received under the CARES Act.
Pharmaceuticals: Revenue from products in the second quarter of 2021 was $35.7 million compared with $29.3 million in the second quarter of 2020, primarily attributable to accelerating growth within OPKO’s international pharmaceutical businesses partially offset by a decline in sales of RAYALDEE. Total prescriptions for RAYALDEE in the second quarter of 2021 decreased to approximately 11,700 from approximately 18,400 in the second quarter of 2020. Revenue from sales of RAYALDEE in the second quarter of 2021 and 2020 was $5.0 million and $8.6 million, respectively. Revenue from the transfer of intellectual property was $9.5 million in the second quarter of 2021 compared with $14.7 million in the 2020 period, reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. The second quarter of 2021 included a $5.0 million upfront payment under the license agreement with Nicoya. Total costs and expenses were $58.9 million in the second quarter of 2021 compared with $50.0 million in the prior year period, primarily due to the growth of OPKO’s international pharmaceutical operations. Operating loss was $13.7 million in the second quarter of 2021 compared with an operating loss of $6.0 million in the second quarter of 2020.
Consolidated: Consolidated total revenues for the second quarter of 2021 were $442.4 million compared with $301.2 million for the comparable period of 2020. Operating income for the second quarter of 2021 was $5.6 million compared with operating income of $27.2 million for the comparable period of 2020. Net loss for the second quarter of 2021, which included an $11.1 million non-cash, non-recurring loss as a result of the issuance of shares in connection with the $55.4 million convertible notes exchange, was $16.2 million, or $0.03 per share, compared with net income of $33.7 million, or $0.05 per diluted share, for the comparable period of 2020.
Cash and equivalents: Cash, cash equivalents and marketable securities were $65.8 million as of June 30, 2021. The Company has availability under its present line of credit with JP Morgan of $64.3 million. Also, in July 2021 OPKO received gross proceeds of $65.0 million from the sale of its fill-and-finish manufacturing facility in Ireland.
Convertible notes: In May 2021, certain noteholders of the Company’s 4.50% Convertible Senior Notes due 2025 agreed to exchange $55.4 million of the outstanding notes for shares of the Company’s common stock, plus a cash payment equal to the accrued and unpaid interest on the exchanged notes.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update, discuss second quarter financial results and answer questions during a conference call and live audio webcast beginning at 4:30 p.m. Eastern time today, July 29, 2021. Participants are requested to pre-register for the conference call using the link here. Upon pre-registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call. Alternatively, please dial (888) 869-1189 or (706) 643-5902 and use conference ID 7028169

To access the live call via webcast, please click on the link OPKO 2Q21 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 2Q21 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 7028169.

On July 29, 2021 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management plans to report its second quarter 2021 financial results on Thursday, August 5, 2021, after the close of the U.S. financial markets (Press release, CTI BioPharma, JUL 29, 2021, View Source [SID1234585380]). Following the announcement, members of the management team will host a conference call and webcast to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT).

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To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 6891246. A live audio webcast of the event may also be accessed through the "Investors" section of CTI’s website at www.ctibiopharma.com. A replay of the webcast will be available for 30 days following the event.

On July 29, 2021 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), reported that it has scheduled its second quarter 2021 financial results and corporate update for Thursday, August 5, 2021 (Press release, Arbutus Biopharma, JUL 29, 2021, View Source [SID1234585397]). The schedule for the press release and conference call/webcast are as follows:

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A live webcast of the conference call can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 2719108.

On July 29, 2021 Cytocom, Inc., (NASDAQ: CBLI), a leading biopharmaceutical company developing next generation therapies that focus on immune homeostasis, reported that it has secured agreements for $90 million in committed capital (Press release, Cytocom, JUL 29, 2021, https://www.prnewswire.com/news-releases/cytocom-inc-receives-commitments-for-90-million-in-equity-and-debt-financing-301343878.html [SID1234585413]). The financing is led by a $75 million equity commitment from GEM Global Yield LLC SCS in the form of a Share Subscription Facility. Cytocom intends to draw down the first $15 million within 30 days of the closing of the recently completed merger between Cleveland BioLabs and Cytocom. A combination of debt and equity financing from Avenue Capital and Adit Ventures, totaling $17 million, will also be made available on a draw schedule. Cytocom will use the proceeds to fund operations, advance growth initiatives, and further clinical development of the company’s internal pipeline. Bridgeway Capital Partners and its affiliates served as the exclusive financial advisor and placement agent on the transaction with Covington & Burling LLP providing legal counsel.

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With access to $90 million in operating capital, subject to customary closing conditions for each draw, Cytocom will continue development of an internal pipeline that includes the company’s platform of toll-like immune receptors. Cytocom’s current clinical programs for COVID-19, Crohn’s Disease, pancreatic cancer and a growing portfolio of immune-modulating therapies under development using Cytocom’s proprietary technology platform are designed to rebalance the body’s immune system and restore homeostasis.

"Having now completed the merger between Cleveland BioLabs and Cytocom, this financing is an essential component to our growth strategy as a public company and should ensure that we have access to capital to continue advancing a cutting-edge clinical pipeline of immune-modulating therapies," stated Michael K. Handley, President and CEO of Cytocom. "Our goal as a company is to become a recognized leader in immune-modulating treatments targeting emerging viruses, including COVID-19, cancer, inflammation and autoimmune diseases. The successful merger, coupled with the acquisition of ImQuest Life Sciences and the previously announced Nasdaq listing, should set the stage for multiple catalysts that we believe will serve to showcase the power of our drug development technologies, generate shareholder value, and raise our visibility within the investor community."

"Avenue Capital is pleased to make this investment as we believe Cytocom could play an important role in developing the next generation of immune-modulating therapies," said Chad Norman, Senior Portfolio Manager for Avenue Venture Opportunities Fund. "There are few companies in the immunology space with such an advanced and differentiated pipeline as Cytocom. Furthermore, we believe the successful merger between Cleveland BioLabs and Cytocom and the acquisition of ImQuest Life Sciences will position the combined company for substantial growth in the years to come."

On July 29, 2021 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the second quarter ended June 30, 2021 (Press release, Emergent BioSolutions, JUL 29, 2021, View Source [SID1234585365]).

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"Our second quarter performance demonstrates the strength of our strategy and diversified business model," said Robert G. Kramer, president and chief executive officer of Emergent BioSolutions. "Through continued investment and innovation, we will play an important role in helping deliver solutions to the public health threats we face. We are proud to be resuming production of COVID-19 vaccine batches following additional reviews and collaboration with the Food and Drug Administration and our manufacturing partner."

Kramer added, "I am thankful for the relentless determination of our Emergent team across the globe to deliver for our patients, customers and partners."

Q2 2021 AND OTHER RECENT BUSINESS ACCOMPLISHMENTS

Announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it can resume production of Johnson & Johnson’s COVID-19 vaccine bulk drug substance at the Company’s Bayview manufacturing facility.
Supporting the U.S. government’s smallpox preparedness efforts under contract options exercised by the Department of Health and Human Services (HHS) valued at approximately $182 million and $56 million to deliver ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) and VIGIV [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV), respectively.
Supporting the Canadian government’s anthrax preparedness efforts under a new contract with the Public Health Agency Canada (PHAC) to deliver Anthrasil (Anthrax Immune Globulin Intravenous [human]) through March 2023.
Received approval from the Federal Agency for Medicines and Health Products (FAMHP) of Belgium for Trobigard Auto-injector (atropine sulfate 2mg/obidoxime chloride 220mg; solution for injection), an emergency treatment product for known or suspected exposure to nerve agents or toxic organophosphates in adults over 18 years of age.
2021 FINANCIAL PERFORMANCE (1)

Product Sales, net
NARCAN Nasal Spray
For Q2 2021, revenues from NARCAN (naloxone HCI) Nasal Spray increased $33.4 million as compared to Q2 2020. The increase is largely driven by a growth in sales to the U.S. public interest and commercial retail markets as well as an increase in sales to customer channels in Canada.

Anthrax vaccines
For Q2 2021, revenues from Anthrax vaccines decreased $80.8 million as compared to Q2 2020. The decrease is largely driven by timing of deliveries to the U.S. government.

ACAM2000
For Q2 2021, revenues from ACAM2000 decreased $70.0 million as compared to Q2 2020. The decrease is largely driven by the timing of deliveries to the U.S. government; the most recent option exercise was received in July 2021 valued at approximately $182 million, the entire amount of which is expected to be delivered in fiscal year 2021.

Other (4)
For Q2 2021, revenues from other product sales were consistent as compared to Q2 2020.

Contract Development and Manufacturing (CDMO) Services
For Q2 2021, revenue from contract development and manufacturing services increased $118.3 million, as compared to Q2 2020. The increase is due to the public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) and arrangements with pharma/biotech innovators to address the COVID-19 pandemic. These arrangements were entered into during the second and third quarters of 2020.

Contracts and Grants
For Q2 2021, revenues from contracts and grants were consistent as compared to Q2 2020.

Operating Expenses

Cost of Product Sales and CDMO Services
For Q2 2021, cost of product sales and contract development and manufacturing services increased $98.0 million as compared to Q2 2020. The increase primarily consists of an increase in costs associated with the Company’s contract development and manufacturing services due to higher volume of CDMO services, a majority of which were in support of the Company’s arrangements to address the COVID-19 pandemic. Additionally, during the quarter the Company had inventory write-offs of $41.5 million associated with raw materials and in-process batches manufactured at the Company’s Bayview facility that it plans to discard as they were deemed unusable. These increases were partially offset by decreases in the cost of product sales due to less volume.

Research and Development
For Q2 2021, research and development expenses were consistent as compared to Q2 2020.

Selling, General and Administrative
For Q2 2021, selling, general and administrative expenses increased $15.2 million as compared to Q2 2020. The increase is primarily due to an increase in costs related to defending and supporting the Company’s corporate reputation.

Additional Financial Information
Gross Margin (2)

For Q2 2021, gross margin decreased $97.0 million as compared to Q2 2020. The decrease is primarily due to the increase in the cost of product sales and CDMO services, specifically $41.5 million associated with the inventory write-offs, $43.1 million associated with product and service revenue mix which was weighted more heavily to lower margin products and services, and $12.4 million associated with costs incurred to remediate and strengthen manufacturing processes at the Company’s Bayview facility, many of which are considered temporary in nature.

For Q2 2021, CDMO services backlog decreased $245.8 million as compared to Q1 2021. The decrease is primarily due to revenue realized in the quarter of $190.9 million, $108.1 million of negative contract modifications and other adjustments offset by $53.2 million of positive new business generation during the quarter.

For Q2 2021, CDMO services opportunity funnel decreased $135.1 million as compared to Q1 2021. The decrease is primarily due to the exclusion of opportunities at the Company’s Bayview facility as all manufacturing activities at that facility are currently prioritized to support the Johnson & Johnson COVID-19 vaccine.

For Q2 2021, capital expenditures increased largely due to the Company’s continued investments associated with increased capacity and capabilities at the Company’s Rockville and Bayview facilities. The increase in gross capital expenditures was offset by reimbursements of $11.4 million related to arrangements funded by the U.S. government.

2021 FINANCIAL FORECAST

For full year 2021, the Company’s forecast includes the following financial metrics:

The Company’s financial forecast for 2021 includes the following additional considerations:

Revised Considerations

Gross margin reflects the impact of the Q2 2021 performance as well as expectations for the remainder of the year.
Unchanged Considerations

Narcan Nasal Spray revenues assume the naloxone market remains competitive and incorporates the impact of at least one new branded entrant into the market by year end, as well as that no generic entrant will enter the market prior to the anticipated appellate decision related to the pending patent litigation, which is expected in the second half of 2021.
Anthrax vaccines revenues are expected to continue to primarily reflect procurement of AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted)​ under the terms of the Company’s existing contract with BARDA at a more normalized annual level.
ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) vaccine revenues incorporate the expected full delivery of product under the $182 million option exercise received in July 2021 as well as other international sales.
CDMO services revenue reflects the successful manufacturing of Johnson & Johnson’s COVID-19 vaccine bulk drug substance. On July 29, the Company announced that it was informed by the FDA that it can resume production at its Bayview manufacturing facility.
Total revenues, specifically other product sales, are expected to be impacted due to the Company’s assumption that a new raxibacumab contract will be awarded later than previously planned.
R&D expenses are expected to reflect continued pipeline progress across the vaccines, therapeutics, and devices portfolios, including the assumption of at least one Phase 3 launch and one Biologics License Application (BLA)/Emergency Use Authorization (EUA) filing.
Capital expenditures, net of reimbursement, are expected to be in a range of 8% to 9% of total revenues, reflecting ongoing investments in capacity and capability expansions in support of the Company’s CDMO services business and product portfolio.
Q3 2021 REVENUE FORECAST

For Q3 2021, the Company expects total revenues of $400 million to $500 million.

FOOTNOTES

(1) All financial information incorporated within this release is unaudited.
(2) See "Reconciliation of Net Income to Adjusted Net Income," "Reconciliation of Net Income to Adjusted EBITDA," "Reconciliation of Gross Margin" and "Reconciliation of Net Research and Development Expenses" for a definition of terms and the reconciliation tables.
(3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts.
(4) Other can include a combination of sales of any of the following products: BAT, VIGIV, Anthrasil, raxibacumab, RSDL, Trobigard, Vivotif, and Vaxchora.
(5) CDMO backlog is defined as estimated remaining contract value as of the indicated period pursuant to signed contracts, the majority of which is expected to be recognized over the next 24 months.
(6) CDMO new business is defined as initial value of contracts secured as well as incremental value of existing contracts modified within the indicated period and is incorporated into Backlog.
(7) CDMO opportunity funnel is defined as proposal values from new work with new customers, new work with existing customers and extensions/expansions of existing contracts with existing customers that, if converted to new business, the majority of which is expected to be realized over the next 24 months. This excludes any value associated with an extension of the commercial supply agreement (CSA) with Johnson & Johnson.

CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, July 29, 2021, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company’s website or through the following: