On July 28, 2021 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2021 (Press release, Integra LifeSciences, JUL 28, 2021, View Source [SID1234585256]).

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"We are pleased with second quarter results that exceeded our forecasts. Our business segments were well-positioned to capitalize on the improving demand driven by the ongoing global market recovery," said Peter Arduini, Integra’s president and chief executive officer. "We saw particularly healthy order activity in products used in neurosurgery, instruments, burn, trauma and surgical reconstruction as markets gradually recovered. Areas such as capital equipment and our international indirect markets are still early in their recovery but are reporting encouraging trends. As a result of our better than expected second quarter financial performance, we are raising our full-year revenue and EPS guidance."

Second Quarter 2021 Consolidated Performance

Total reported revenues of $390.0 million increased 50.8% on a reported basis and 48.7% on an organic basis compared to the prior year. Total reported revenues include $17.7 million from the acquisition of ACell, which was completed on January 20, 2021.

The Company reported GAAP gross margin of 61.2%, compared to 59.2% in the second quarter of 2020. Adjusted gross margin was 68.1% compared to 66.2% in the prior year.

Adjusted EBITDA for the second quarter of 2021 was $101.0 million, or 25.9% of revenue, compared to $52.8 million, or 20.4% of revenue in the prior year. Adjusted EBITDA margins benefited from higher revenue and higher adjusted gross margins, partially offset by higher operating expenses attributable to the gradual return of spending, which was reduced during the same period in the prior year in response to the global pandemic.

The Company reported GAAP net income of $35.1 million, or $0.41 per diluted share, in the second quarter of 2021, compared to a GAAP net loss of $(0.4 million), or $(0.00) per diluted share, in the prior year.

Adjusted net income for the second quarter of 2021 was $67.4 million, or $0.79 per diluted share, compared to $28.4 million, or $0.33 per diluted share, in the prior year.

Second Quarter 2021 Segment Performance

Codman Specialty Surgical (66% of Revenues)

Total revenues were $256.8 million, representing reported growth of 51.3% and organic growth of 49.5% compared to the second quarter of 2020. Broad-based strength in both neurosurgery and instruments were driven by a recovery in demand.
Tissue Technologies (34% of Revenue)

Total revenues were $133.2 million, representing reported growth of 49.8% and organic growth of 47.1% compared to the second quarter of 2020. Growth was led by strength in burn, trauma and surgical reconstruction.
Strategic Initiatives and Key Developments

Advancing key products

Cerelink – next generation intracranial pressure monitor is scheduled for a controlled market release in the third quarter.
Aurora Surgiscope in minimally invasive tumor removal procedures – a targeted phased market launch will begin in the third quarter to generate clinical evidence and gain insights for a broader commercial launch in the second half of 2022.
PriMatrix Dermal Repair Scaffold – during the second quarter, the Company completed a randomized clinical study of PriMatrix for use in the closure of Diabetic Foot Ulcers (DFUs). This multi-center study enrolled over 225 patients and found that PriMatrix demonstrated statistically and clinically significant results, healing more DFUs in 12 weeks versus standard of care, with a median number of one application. The results of this study have been published in the Journal of Wound Care.
The Company announced that Peter Arduini will step down as Chief Executive Officer at the end of 2021 to accept the role of President and Chief Executive Officer of GE Healthcare. The Board of Directors has initiated a formal search and appointed a special committee to direct the search and ensure a seamless transition of responsibilities.
Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $91.3 million in the quarter. The Company paid down $100 million of debt on its senior credit facility during the second quarter. Net debt at the end of the quarter was $1,166 million and the consolidated total leverage ratio was 2.4x, an improvement of 0.6x from December 31, 2020.

As of quarter end, the Company had total liquidity of approximately $1.7 billion, including approximately $397 million in cash and the remainder available under the revolving credit facility.

2021 Outlook

The Company is providing forward-looking guidance regarding adjusted earnings per diluted share, but is not providing a reconciliation to GAAP earnings per share, because certain GAAP expense items are highly variable and management is unable to predict them with reasonable certainty and without unreasonable effort. Specifically, the financial impact and timing of divestitures, acquisitions, integrations, structural optimization and efforts to comply with the EU Medical Device Regulation are uncertain, depend on various dynamic factors and are not reasonably ascertainable at this time. These expense items could have a material impact on GAAP results. Adjusted earnings per diluted share also excludes the impact of intangible asset amortization associated with prior business acquisitions, which we expect to be approximately $0.71 per diluted share for the full-year 2021.

In addition, the Company will continue to monitor the ongoing uncertainty around the scope and duration of the pandemic and its impact on financial performance. The Company does not expect the ongoing impact of the pandemic to be uniform across all markets and product lines. The Company’s guidance assumes a gradual improvement in surgical procedures with no further setbacks from new surges or new COVID variants.

Full-Year 2021 Outlook

The Company is raising its full-year 2021 revenue guidance by $15 million to a range of $1,540 million to $1,550 million from $1,525 million to $1,535 million. This new guidance range represents a reported growth range of 12% to 13% and an organic growth range of 13% to 14%. The Company is also raising its full-year 2021 adjusted earnings per share guidance to new range of $2.98 to $3.05, from its prior range of $2.86 to $2.93.

The Company has revised its outlook for a revenue contribution from ACell to $70 million to $74 million for the full-year 2021, from its previous range of $83 million to $88 million, due to the impact of an accelerated integration of the sales force during the pandemic. The Company remains confident in the long-term growth expectations for the ACell portfolio. Strong performance in other parts of the CSS and TT businesses more than offset the slower start in ACell and are included in the new total company revenue guidance range.

Third Quarter Outlook

For the third quarter 2021, the Company expects revenues to be in a range of $382 million to $389 million, representing reported growth of approximately 3% to 5% and organic growth of 5% to 7%. Adjusted earnings per diluted share are expected to be in a range of $0.71 to $0.74.

In the future, the Company may record, or expects to record, gains or losses, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET today, Wednesday, July 28, 2021, to discuss financial results for the second quarter. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the prepared remarks.

Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.

Access to the live call is available by dialing (800) 367-2403 and using the passcode 3706513. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available until August 7, 2021 by dialing (888) 203-1112 and using the passcode 3706513. The webcast will also be archived on the website.

On July 28, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the second quarter ended June 30, 2021, after the market close on Thursday, August 12, 2021, and will host a corporate update conference call at 4:30pm Eastern Time (Press release, CorMedix, JUL 28, 2021, View Source [SID1234585277]).

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On July 28, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported its financial results for the second quarter and the first half year of 2021 (Press release, MorphoSys, JUL 28, 2021, View Source [SID1234585294]).

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"We regained the momentum in Monjuvi sales as we exited the second quarter and are encouraged to see that momentum continuing into Q3," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are seeing the positive impact to our business from the vaccination rollout in the U.S., and remain focused on establishing tafasitamab as a standard of care in the treatment of patients with relapsed/refractory DLBCL."

"With the addition of Constellation’s clinical programs to our pipeline, we are in a great position to build a significant presence in hematology-oncology with multiple commercial opportunities."

Tafasitamab Highlights

– Monjuvi(R) (tafasitamab-cxix) U.S. net product sales of € 14.9 million (US$ 18.0 million) for the second quarter of 2021 and € 27.8 million (US$ 33.5 million) for the first half of 2021.

– On April 19, 2021, MorphoSys and Incyte announced that the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

– On May 11, 2021, MorphoSys and Incyte announced that the first patient was dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL).

– From June 4-8, 2021, MorphoSys presented new data from the tafasitamab development program at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Data from the three-year follow-up from the Phase 2 L-MIND study showed a long durability of responses and overall survival in patients with r/r DLBCL.

– On June 25, 2021, MorphoSys and Incyte announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization for tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). The Committee for Orphan Medicinal Products (COMP) has also confirmed the orphan drug designation status in mid-July.

– Together with MorphoSys, Incyte plans to start coreMIND, a pivotal Phase 2 study that will assess tafasitamab in combination with Incyte’s Pi3 kinase delta inhibitor in patients with chronic lymphocytic leukemia (CLL).

– MorphoSys will also initiate MINDway, a study that will look into finding the best treatment schedule for patients with Non-Hodgkin Lymphoma (NHL) who benefit from long-term disease-control from tafasitamab.

Acquisition of Constellation Pharmaceuticals and Strategic Funding Partnership

– On June 2, 2021, MorphoSys entered into a definitive agreement to acquire Constellation Pharmaceuticals (Constellation) for US$ 34.00 per share in cash, which represents a total equity value of US$ 1.7 billion. The transaction has been unanimously approved and subsequently was completed on July 15, 2021.

– MorphoSys gets access to mid- to late-stage product candidates: Pelabresib (CPI 0610) has the potential to be a first-in-class and best-in-class BET inhibitor that is currently being evaluated in a Phase 3 trial for the treatment of myelofibrosis. CPI-0209 is a mid-stage EZH2 inhibitor, which is currently in a Phase 2 clinical trial and has best-in-class potential for treating both hematologic and solid tumors.

– MorphoSys entered into a long-term strategic funding partnership with Royalty Pharma:

– US$ 1.425 billion upfront payment

– Up to US$ 350 million in Development Funding Bonds

– Up to US$ 150 million milestone payments

– Royalty Pharma Investments 2019 ICAV, a subsidiary of Royalty Pharma plc, purchased US$ 100 million in shares (1,337,552 shares) of MorphoSys at a price of € 63.35 per share on July 16, 2021

– MorphoSys also announced today that Jigar Raythatha, President and Chief Executive Officer of Constellation, will resign effective July 31, 2021. Barbara Krebs-Pohl, PhD, Senior Vice President, Global Head of Business Development, Licensing, and Alliance Management at MorphoSys, has been appointed as Site Head of Constellation and Chief Integration Officer.

Tremfya:

– MorphoSys to continue to record Tremfya royalties on its income statement. Royalty Pharma is entitled to receive 100 percent of Tremfya royalties starting with royalties for the second quarter of 2021.

– Tremfya royalties of € 13.7 million for the second quarter of 2021 and € 25.4 million for the first half of 2021.

Financial Results for the Second Quarter of 2021 (IFRS)
Total revenues for the second quarter of 2021 amounted to € 38.2 million (Q2 2020: € 18.4 million). The revenues include success-based payments of € 14.2 million, primarily from Janssen (Q2 2020 success-based payments: € 12.8 million).

Cost of Sales: In the second quarter of 2021, cost of sales increased to € 10.1 million (Q2 2020: income of € 7.2 million).

Research and Development (R&D) Expenses: In the second quarter of 2021, research and development expenses were € 40.5 million (Q2 2020: € 30.9 million). Growth over 2020 reflects the increased investment to support the advancement of proprietary programs and consisted primarily of expenses for external laboratory services and personnel expenses.

Selling, General and Administrative (SG&A) Expenses: Selling expenses decreased slightly in the second quarter of 2021 to € 28.5 million (Q2 2020: € 29.3 million) and general and administrative expenses amounted to € 30.5 million (Q2 2020: € 13.8 million). The increase of general and administrative expense in the second quarter was due to the transaction costs related to the Constellation and Royalty Pharma agreements.

Operating Loss: Operating loss amounted to € 71.4 million in the second quarter of 2021 (Q2 2020: operating loss of € 48.4 million).

Consolidated Net Profit / Loss: For the second quarter of 2021, consolidated net profit was € 20.9 million (Q2 2020: consolidated net loss of € 53.1 million).

Financial Results for the First 6 Months of 2021 (IFRS)

Total revenues for the first six months of 2021 amounted to € 85.4 million (H1 2020: € 269.7 million). The revenues include success-based payments of € 43.1 million, primarily from Janssen (H1 2020 success-based payments: € 23.1 million) The year-over-year decline was driven by the upfront payment of the collaboration and license agreement with Incyte in the first quarter 2020 for the out-licensing of tafasitamab outside the U.S.

Cost of Sales: In the first six months of 2021, cost of sales increased to € 15.2 million (H1 2020: income of € 4.0 million).

Research and Development (R&D) Expenses: In the first six months of 2021, research and development expenses were € 73.8 million (H1 2020: € 52.4 million). Growth over 2020 reflects the increased investment to support the advancement of proprietary programs and consisted primarily of expenses for external laboratory services and personnel expenses.

Selling, General and Administrative (SG&A) Expenses: Selling expenses increased in the first six months of 2021 to € 56.6 million (H1 2020: € 42.1 million) and general and administrative expenses amounted to € 40.8 million (H1 2020: € 23.9 million). The year-over-year increase in selling expenses was primarily driven by the full first half year 2021 impact of the expenses for services provided by Incyte as part of the joint U.S. marketing activities for Monjuvi. The year-over-year increase in general and administrative expenses was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements.

Operating Loss: Operating loss amounted to € 101.0 million in the first six months of 2021 (H1 2020: operating profit of € 155.1 million).

Consolidated Net Profit / Loss: For the first six months of 2021, consolidated net loss was € 20.7 million (H1 2020: consolidated net profit of € 179.8 million).

Cash and Investments: As of June 30, 2021, the Company had cash and investments of € 1,129.2 million compared to € 1,244.0 million on December 31, 2020. Pro forma cash after the closing of the Constellation and Royalty Pharma transactions, including the sale of ordinary shares, was € 1,168.0 million.

Number of shares: The number of shares issued totaled 32,892,540 at the end of Q2 2021 (year-end 2020: 32,890,046). After the share capital increase on July 16, 2021, to implement the purchase of 1,337,552 new ordinary shares by Royalty Pharma, the number of shares issued totaled 34,227,598.

Adjusted Financial Guidance and Operational Outlook for 2021

in € million Updated Financial Guidance 2021 Prior Financial Guidance (ex-Constellation)

*Group revenues include full year Tremfya royalties and exclude any royalties from potential tafasitamab sales outside of the U.S. as well as any significant milestones from development partners and/or licensing partnerships other than those that were already recorded in the half-year. This revenue guidance is subject to a number of uncertainties including the potential for variability from the first full year of the Monjuvi product launch, the limited visibility that MorphoSys has on the Tremfya royalty stream as well as the ongoing COVID-19 pandemic and the impact on our as well as our partner’s business operations.

**Operating expenses is comprised of R&D and SG&A, inclusive of Incyte’s share of Monjuvi selling costs in the U.S.

MorphoSys expects the following events and activities in 2021:

Tafasitamab:

– Continuation of the phase 1b trial with tafasitamab in previously untreated DLBCL (firstMIND);

– Continuation of the pivotal phase 3 frontMIND trial of tafasitamab in previously untreated DLBCL;

– Continuation of the pivotal phase 3 inMIND trial of tafasitamab in patients with relapsed or refractory follicular lymphoma (r/r FL) or marginal zone lymphoma (MZL);

– Investigation of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL, first-line DLBCL and relapsed or refractory follicular lymphoma (r/r FL) jointly with Incyte and Xencor (study start expected end of 2021/early 2022);

– Continuation of the L-MIND study of tafasitamab and evaluate the long-term efficacy and safety data;

– Continuation of the phase 3 B-MIND study of tafasitamab in combination with bendamustine for r/r DLBCL;

– Decision of the European Commission on the Marketing Authorization Application (MAA), seeking conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with r/r DLBCL which is currently under review;

– Support of Incyte in submitting marketing authorization applications in other markets for tafasitamab.

Felzartamab:

– Continuation of the M-PLACE and the NewPLACE study in patients with membranous nephropathy;

– Presentation of data from the M-PLACE study at a scientific conference in Q4 2021;

– Start of clinical study in patients with IgA nephropathy (IGNAZ study).

Constellation programs:

– Continuation of the MANIFEST phase 2 study of pelabresib in patients with myelofibrosis;

– Continuation of the MANIFEST-2 phase 3 clinical study with pelabresib in combination with ruxolitinib in patients with primary myelofibrosis;

– Continuation of a Phase 1/2 clinical trial of CPI-0209 in patients with advanced solid and hematological tumors.

MorphoSys will hold its conference call and webcast tomorrow, July 29, 2021, to present the results for the second quarter and first half year of 2021 and the further outlook for 2021.

A live webcast and slides will be made available at the Investors section under "Presentations and Conferences" on MorphoSys’ website at View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

The statement for the second quarter/first 6 months of 2021 (IFRS) is available online:
View Source/Reports

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

On July 28, 2021 PerkinElmer, Inc., a global leader committed to innovating for a healthier world, reported four new ready-to-use AlphaLISA KRAS kits, designed to help scientists better understand complex KRAS protein structures and mutations so they can more easily, quickly, and precisely identify potential new therapeutic candidates for a wide range of prevalent cancers (Press release, PerkinElmer, JUL 28, 2021, View Source [SID1234585311]). Researchers will now be able to choose between PerkinElmer’s HTRF or AlphaLISA assays to use the best methods for their individual labs.

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The Company’s AlphaLISA and HTRF kits are the first ready-to-use homogenous assays for KRAS/SOS1 inhibition analysis on the market. Prior to these offerings, labs looking to measure this inhibition in a no-wash format needed to develop their own assays, source their own proteins, and optimize assay conditions, which can be time and resource consuming. PerkinElmer’s AlphaLISA and HTRF kits streamline workflows by offering fully validated kits to identify novel KRAS inhibitors in a no-wash format with no optimization necessary, and each kit comes with recombinant proteins, detection reagents, and assay buffers.

"KRAS mutations are present in approximately 25% of tumors, making them one of the most common gene mutations linked to cancer," said Alan Fletcher, senior vice president of life sciences and technology, PerkinElmer. "Because KRAS mutations are found in numerous types of cancer, from lung to colorectal to pancreatic cancers, it’s a prime drug target. However, due to its complex protein structure, it’s been quite difficult to research for many years. We’re proud to help advance opportunities for researchers to learn more about KRAS mutations in the hopes of providing better treatment opportunities by bringing our AlphaLISA kits to market in this critical research space."

The addition of these assays further propels PerkinElmer’s ability to provide end-to-end solutions for oncology researchers, which includes early stage drug discovery with assays, cell lines, microplates and plate readers, as well as later stage research with high-content screening, image analysis and management, automated liquid handling, and more. Learn more about PerkinElmer’s cancer research solutions for genomics, cell-based assays, cellular imaging, in vivo imaging, and informatics here.

Learn more about the new AlphaLISA KRAS assay kits here and about the Company’s drug discovery technologies here.

On July 28, 2021 Nuvalent, Inc., a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the pricing of its initial public offering of 9,750,000 shares of common stock, consisting of 9,150,000 shares of Class A common stock and 600,000 shares of Class B common stock, each at a price to the public of $17.00 per share (Press release, Nuvalent, JUL 28, 2021, View Source [SID1234585328]). All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $165.75 million. The Class A common stock is expected to begin trading on The Nasdaq Global Select Market under the ticker symbol "NUVL" on July 29, 2021. The offering is expected to close on August 2, 2021, subject to the satisfaction of customary closing conditions. In addition, the underwriters have a 30-day option to purchase up to an additional 1,462,500 shares of Class A common stock at the initial public offering price less underwriting discounts and commissions.

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J.P. Morgan, Cowen and Piper Sandler are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on July 28, 2021. The offering is being made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone (866) 803-9204 or by email at [email protected]; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; and Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.