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Radius Health Reports First Quarter 2018 Financial and Operating Results and Provides Business Update

On May 10, 2018 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), reported its financial results for the first quarter ended March 31, 2018 and provided a business update (Press release, Radius, MAY 10, 2018, View Source [SID1234526493]).

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"The Company’s first quarter results highlight the strong performance of TYMLOS in the U.S. anabolic osteoporosis market, having captured one third of new patient starts with bone building anabolic therapy within less than a year of our commercial launch," said Jesper Hoeiland, President and Chief Executive Officer of Radius. "We remain focused on further increasing our market penetration and are committed to achieving leadership in the anabolic market with our differentiated and responsibly priced drug."

"I’m also very pleased that we made significant progress in advancing our clinical pipeline. Having finalized our development pathways for elacestrant and abaloparatide-patch, we remain on track with our preparations to launch these global pivotal studies," Mr. Hoeiland concluded.

TYMLOS (abaloparatide) injection

First quarter 2018 sales of TYMLOS in the U.S. were $14.5 million, an increase of 90% from the fourth quarter of 2017. TYMLOS prescriptions reached 31% of new anabolic patient starts (based on New Patients to Brand, NBRx PMOT) and 13% of the total U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) in the first quarter of 2018.

Less than a year after launch, TYMLOS has surpassed the level of U.S. commercial market access for the competing anabolic product, with 95% coverage in commercial plans. TYMLOS coverage in Medicare Part D plans has also increased to 43%. 263 million lives now have access to TYMLOS representing 88% of the total insured US population.

At the Academy of Managed Care Pharmacy (AMCP) Annual Meeting on April 25th, Radius presented two posters in support of the clinical and cost-effective value of treating earlier with TYMLOS to build bone followed by antiresorptive maintenance treatments. The findings demonstrate that sequential therapy of TYMLOS followed by generic alendronate was shown to improve outcomes at a lower total cost of care compared to teriparatide followed by generic alendronate for the treatment of US women at high risk for fracture. Further, sequential therapy with TYMLOS followed by generic alendronate was shown to improve outcomes at a lower total cost of care compared to starting with generic alendronate for women at high risk of fracture.

There was a 103% increase in the total number of U.S. physicians prescribing TYMLOS in the first quarter of 2018 versus the previous quarter. TYMLOS’ share of the total anabolic volume written by these physicians increased from 20% in the fourth quarter of 2017 to 38% in the first quarter of 2018. TYMLOS’ share of new prescriptions written by these physicians increased from 32% in the fourth quarter of 2017 to 49% in the first quarter of 2018.

The Company’s Awareness Trial and Usage Survey in the first quarter of 2018 showed TYMLOS reaching 80% of aided awareness, and a high intention by physicians to treat with TYMLOS, surpassing the competing anabolic product in the market.

Radius expects TYMLOS to capture on average 19-21% of the U.S. anabolic osteoporosis market in 2018 and that the U.S. anabolic market will continue its positive growth trajectory since TYMLOS was launched in May 2017, with an expected 5-7% volume increase.

A 5.9% price increase for TYMLOS took effect on February 22, 2018.
Pipeline Highlights

Abaloparatide -Transdermal Patch (abaloparatide-patch)

In Q1 2018, Radius finalized a development pathway for abaloparatide-patch after regulatory alignment with the FDA and entered into a scale-up and commercial supply agreement with 3M Company (3M).

The Company is on track with its ongoing efforts with partner 3M to increase manufacturing capacity to support the pivotal study and for clinical and non-clinical studies that will be included in a future New Drug Application (NDA) submission. The Phase 3 study of abaloparatide-patch is planned to start in mid-2019.
Abaloparatide – Subcutaneous (SC)

European MAA
In March 2018, Radius announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a negative opinion on the Company’s marketing authorization application (MAA) for abaloparatide-SC for the treatment of osteoporosis in postmenopausal women at increased risk for fracture. In April 2018, Radius submitted a request for re-examination of the CHMP’s opinion.
Male Osteoporosis Trial

In March 2018 Radius initiated the Phase 3 ATOM (Abaloparatide Treatment for Osteoporosis in Males) study of abaloparatide-SC for the treatment of osteoporosis in men, which, if successful, will form the basis of a supplemental NDA seeking to expand TYMLOS’ label. The study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 225 men with osteoporosis at high risk of fracture. The study will include a primary endpoint of change in lumbar spine bone mineral density ("BMD") at 12 months versus placebo, and specialized high-resolution imaging of bone structure in a subset of the study participants.

Male osteoporosis is estimated to account for approximately 10% of the total treated osteoporotic patient population.
Elacestrant (RAD1901)

Based on EMA and FDA feedback, Radius announced in March 2018 that it will conduct a single, randomized, comparator controlled Phase 3 trial of elacestrant as a third-line monotherapy in approximately 300 patients with ER positive/HER2 negative advanced/metastatic breast cancer. Depending on the results, this study is expected to support applications for global marketing approvals for elacestrant. Patients in the study would be randomized to receive either elacestrant or an investigator’s choice of an approved hormonal agent and the primary endpoint of the study will be progression-free survival (PFS). Start-up activities for the randomized study are well underway and Radius will provide further study details when the Phase 3 trial is initiated, which the Company expects will be in the second half of 2018.
RAD140

Patient enrollment is ongoing in the Phase 1 study evaluating the safety and maximum tolerated dose of RAD140, a nonsteroidal selective androgen receptor modulator (SARM), in patients with hormone receptor-positive, locally advanced or metastatic breast cancer. The Company expects to provide an update on the RAD140 development program by the end of 2018.
Operational Activities

In March 2018, the Company consolidated operations in its headquarters in Waltham, Massachusetts and office in Wayne, Pennsylvania. As part of this consolidation, Radius’ Parsippany, New Jersey office will be closed.
Anticipated Upcoming Milestones

Elacestrant
Initiate a Phase 3 clinical trial as third-line monotherapy in advanced/metastatic ER-positive/HER2-negative breast cancer patients in the second half of 2018
Collaboration agreement for elacestrant combination therapy
RAD140
Continue enrollment in the Phase 1 study and provide a program update by the end of 2018

Abaloparatide
Initiate clinical bone histomorphometry study in the first half of 2018
Publication of ACTIVExtend Phase 3 data
Enter into a partnership for the potential commercialization of abaloparatide-SC outside the US and Japan
Expected Radius Presentations at Upcoming Conferences in 2Q 2018

On May 15-17, the Company will present and host one-on-one meetings at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas, Nevada.
On June 12-14, the Company will present and host one-on-one meetings at the Goldman Sachs Global Healthcare Conference in Palos Verdes, California.
First Quarter 2018 Financial Results

For the three months ended March 31, 2018, Radius reported a net loss of $61.6 million, or $1.37 per share, compared to a net loss of $56.9 million, or $1.32 per share, for the three months ended March 31, 2017.

For the three months ended March 31, 2018, Radius reported TYMLOS net product revenues of $14.5 million compared to zero TYMLOS revenue in the three months ended March 31, 2017.

Research and development expense for the three months ended March 31, 2018, was $22.9 million compared to $19.5 million for the three months ended March 31, 2017, an increase of $3.4 million, or 17%. This increase was primarily driven by a $2.5 million increase in abaloparatide-SC project costs, a $0.6 million increase in elacestrant project costs, a $0.3 million increase in RAD140 project costs, and a $0.1 million increase in abaloparatide-patch project costs. These increases were partially offset by a $0.9 million decrease in vasomotor project related spending. Additionally, there was an increase in headcount from 111 research and development employees as of March 31, 2017 to 131 research and development employees as of March 31, 2018.

For the three months ended March 31, 2018, selling, general and administrative expense was $48.0 million compared to $38.1 million for the three months ended March 31, 2017, an increase of $9.9 million, or 26%. This increase was primarily the result of a $6.6 million and $2.3 million increase in compensation and travel related expenses, respectively, due to an increase in headcount from 363 selling, general and administrative employees as of March 31, 2017 to 405 selling, general and administrative employees as of March 31, 2018.

As of March 31, 2018, Radius had $367.3 million in cash, cash equivalents and marketable securities. Based upon the Company’s cash, cash equivalents and marketable securities balance as of March 31, 2018, the Company believes that, prior to the consideration of proceeds from partnering and/or collaboration activities, it has sufficient capital to fund its development plans, U.S. commercial and other operational activities for not less than twelve months from the date of this press release.

Novelion Therapeutics Reports First Quarter 2018
Financial Results

On May 10, 2018 Novelion Therapeutics Inc. (NASDAQ: NVLN), a biopharmaceutical company dedicated to developing and commercializing therapies for individuals living with rare diseases ("Novelion" or the "Company"), reported financial results for the first quarter ended March 31, 2018 and provided an overview of business activities (Press release, QLT, MAY 10, 2018, View Source [SID1234526492]).

Chief Operating Officer Jeff Hackman said, "Thus far in 2018 we have executed a number of important initiatives, including finalizing the settlements with the DOJ, reducing costs, strengthening our balance sheet with a $20 million term loan, and reviewing our holding and capital structure with a goal of optimizing our assets for shareholders. We have a strong rare disease product portfolio that carries the opportunity to expand metreleptin into new disease areas, and which we believe will deliver meaningful future sales growth. We remain focused on continuing to market important therapies that will bring value to our patients."

Business Update

JUXTAPID: Novelion reported net revenues of JUXTAPID of $13.4 million in the first quarter of 2018, $8.6 million, or 64%, of which were from prescriptions written in the U.S.

MYALEPT: Novelion reported net revenues of MYALEPT of $14.1 million in the first quarter of 2018, $9.8 million, or 69%, of which were from prescriptions written in the U.S.

Novelion reported total consolidated net revenues of $27.5 million in the first quarter of 2018.

Novelion ended the first quarter of 2018 with $52.0 million in unrestricted cash, compared with $55.4 million at the end of 2017. The $52.0 million includes proceeds from a $20.0 million term loan to Aegerion Pharmaceuticals, Inc. ("Aegerion") provided by affiliates of Sarissa Capital Management and Broadfin Capital LLC, as announced in March 2018.

The Company expects the opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use ("CHMP") on the metreleptin marketing authorization application in the second quarter of 2018, followed by a mid-2018 European Commission approval decision.

Novelion announced that a poster describing the results of a metreleptin study for weight loss in overweight and obese adults with low leptin levels will be presented at the American Diabetes Association’s 78th Annual Scientific Sessions which is being held from June 22 to June 26, 2018 in Orlando, Florida.

First Quarter 2018 Financial Results

GAAP total net revenues for the first quarter of 2018 were $27.5 million compared to $30.0 million for the same period of 2017. GAAP net revenues for JUXTAPID in the first quarter of 2018 were $13.4 million compared to $16.0 million for the same period in 2017. GAAP net revenues for MYALEPT in the first quarter of 2018 were $14.1 million compared to $14.0 million for the same period in 2017.

GAAP total operating expenses for the first quarter of 2018 were $35.5 million compared to total operating expenses of $35.2 million for the same period in 2017. GAAP SG&A expenses were $23.7 million in the first quarter of 2018 compared to $24.5 million for the same period in 2017. GAAP R&D expenses were $11.8 million in the first quarter of 2018 compared to $9.3 million for the same period in 2017.

On a pro forma basis, during the first quarter of 2018, SG&A expenses were $21.6 million compared to $23.0 million for the same period in 2017. The decrease in pro forma SG&A expenses in the first quarter of 2018 compared with the same period in 2017 was primarily related to a reduction in headcount and legal and consulting fees.

On a pro forma basis, during the first quarter of 2018, R&D expenses were $11.6 million compared to $9.0 million for the same period in 2017. The increase in pro forma R&D expenses in the first quarter of 2018 compared with the same period in 2017 was primarily related to additional spending in certain clinical activities.

GAAP net loss in the first quarter of 2018 was $32.8 million compared to GAAP net loss of $31.0 million during the same period in 2017.

On a pro forma basis, net loss in the first quarter of 2018 was $13.5 million, compared to a loss of $8.7 million for the same period in 2017.

As of March 31, 2018, the Company’s consolidated unrestricted cash balance was $52.0 million, compared to $55.4 million at December 31, 2017. As of March 31, 2018, there were18.7 million shares outstanding. Convertible debt principal is $325.0 million, reflecting the amount of convertible debt, before discount, issued by subsidiary Aegerion. In addition, as described above, in March 2018, Novelion’s subsidiary, Aegerion, entered into a secured financing facility with affiliates of Sarissa Capital Management and Broadfin Capital LLC providing for a $20.0 million term loan to Aegerion.

Polaris Signs Collaboration Agreement with MD Anderson Cancer Center to Join its Immunotherapy Platform for Clinical Trials and Preclinical Research

On May 10, 2018 Polaris Group reported that it has signed a multiyear strategic Collaboration Agreement with MD Anderson Cancer Center to utilize its Immunotherapy Platform, led by world-renowned immunotherapy pioneer Dr. James Allison, Dr. Padmanee Sharma, and Dr. Patrick Hwu, to design clinical studies and monitor biomarkers in immune functions associated with the therapies (Press release, Polaris Pharmaceuticals, MAY 10, 2018, View Source [SID1234526491]).

As one of the ten research platforms that support the Cancer Moon Shots ProgramTM, MD Anderson’s Immunotherapy Platform conducts preclinical research to assess feasibility and efficacy of new treatments; it also monitors immune function changes as a result of clinical therapies through cellular and molecular analysis of patient samples in hope of discovering biomarkers for personalized medicine.

"We are very excited to join MD Anderson’s Immunotherapy Platform and be part of its cutting-edge pre-clinical and clinical research programs in the immunotherapy area," said Dr. Bor-Wen Wu, CEO of Polaris Group. "We believe the unique mechanism of action of ADI‑PEG 20 may complement that of the existing immunotherapy drugs, hence potentially achieve higher overall efficacy as combination therapy. We look forward to having a fruitful collaboration on our journey to develop more effective treatments, and the exploration of other immunotherapy targets."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20

Pfenex Reports First Quarter 2018 Results and Provides Business Update

On May 10, 2018 Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology to improve protein therapies for unmet patient needs, reported financial results for the first quarter ended March 31, 2018 and provided a business update (Press release, Pfenex, MAY 10, 2018, View Source [SID1234526490]).

"We are on track to report topline results from our PF708-301 Phase 3 trial in the second quarter. This study compares PF708, a therapeutic equivalent to Forteo, to Forteo after 24 weeks of daily treatment in osteoporosis patients. If the data from the trial are in line with our expectations, this will be a significant milestone for our lead program. Assuming sufficiently positive results from our PF708-301 Phase 3 trial, we plan to submit the NDA for PF708-301 to the FDA in the third quarter," stated Eef Schimmelpennink, chief executive officer of Pfenex. "I am a strong believer in the value of leveraging key competencies different parties may have, and to that extent we continue to evaluate commercial partnership opportunities for PF708, in parallel to planning and preparing to potentially bring the product to the market ourselves. Importantly, we will always focus on the pathway that creates the most value for our stockholders. To that end, we recently entered into a development and license agreement with NT Pharma for our PF708 product, through which they will oversee the regulatory and commercialization activities for the product in Mainland China, Hong Kong, Singapore, Malaysia and Thailand. NT Pharma’s demonstrated experience in the orthopedic space makes them a valuable partner in this territory."

"Beyond advancing our current pipeline, our development partnerships with Jazz, NT Pharma, BARDA and CRM197, our long-term strategy is to fill out our pre-clinical and clinical pipelines with new programs created through our Pfēnex Expression Technology Platform. We look forward to leveraging the platform’s high rate of success in developing complex therapeutic proteins, our experienced clinical research team and our network of development and commercialization partners. This strategy strengthens the business through a more diversified pipeline to build stockholder value," concluded Schimmelpennink.

Business Review and Update

PF708 therapeutic equivalent to Forteo (teriparatide)

In April, Pfenex entered an agreement under which Pfenex granted NT Pharma non-exclusive development and exclusive commercialization rights to PF708 in Mainland China, Hong Kong, Singapore, Malaysia and Thailand. In accordance with the agreement, Pfenex may be eligible to receive up to $25 million in payments based on the achievement of certain development, regulatory and sales-related milestones. In addition, Pfenex is eligible to receive double-digit royalties on any future net product sales. NT Pharma will be responsible for any further development required to achieve regulatory approval as well as commercialization activities in the applicable territories.

In February 2018, Pfenex completed the last patient visit for its on-going PF708-301 trial. The trial compares PF708 and Forteo after 24 weeks of daily treatment in osteoporosis patients. Pfenex expects top-line immunogenicity data results in the second quarter of 2018. Pfenex believes that results from its PF708-301 trial, if sufficiently positive, along with the previously-announced bioequivalence findings from its Study PF708-101 in healthy subjects will support submitting a New Drug Application (NDA) for PF708 in the United States. Assuming sufficiently positive results from its PF708-301 trial, Pfenex expects to submit an NDA to the U.S. Food and Drug Administration (FDA) in the third quarter of 2018, with a potential commercial launch possible in the United States as early as the third quarter of 2019, subject to receipt of FDA marketing authorization.

Jazz Collaboration Agreement

Pfenex and Jazz Pharmaceuticals are collaboratively developing certain hematology/oncology products, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology. Jazz will have the exclusive right to manufacture and commercialize such products throughout the world. Under the agreement with Jazz, Pfenex will be eligible to receive up to $224.5 million in total value of payments and potential payments associated with the collaboration. To date, Pfenex has received $35.2 million through this agreement. Pfenex may also be eligible to receive tiered royalties on worldwide sales of any products resulting from the collaboration.

Px563L and RPA563

The development of Pfenex’s novel anthrax vaccine candidates is funded through an advanced development contract with the Department of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA) valued at up to approximately $143.5 million. Potential next milestones in 2018 are triggering of analytical and non-clinical animal study options leading to a potential Phase 2 study in 2019, subject in each case to continued funding by BARDA.

CRM197

Pfenex provided an update on a legacy program, CRM197, for which Pfenex has several development and commercial partnerships in place. CRM197 is a non-toxic mutant of diphtheria toxin. It is a well characterized protein and functions as a carrier for polysaccharides and haptens making them immunogenic. In the early days of its existence, Pfenex developed a unique CRM197 based on its Pfēnex Expression Technology platform and sells non-GMP and cGMP CRM197 to mostly vaccine development focused pharmaceutical partners. As a result of those efforts, Pfenex previously entered into commercial licenses for production strains capable of producing CRM197 with both Merck and Serum Institute of India. Pfenex’s CRM197 is currently being used or planned to be used in multiple late-stage clinical trials for such diseases as pneumococcal and meningitis bacterial infections.

Financial Highlights for the First Quarter 2018

Total Revenue increased to $3.7 million in the three-month period ended March 31, 2018, compared to $2.8 million in the same period in 2017. The increase in revenue was due to additional activity related to development of Pfenex’s Px563L product candidate under its government contract, as two options were exercised by the government in 2017. Minimal activity related to planning and start-up activities for the new options occurred in early 2017, progressing to increased development activities later in the year and into 2018. Reagent protein product sales also increased. In addition, as a result of an amended license agreement with Jazz signed in December 2017, license revenue increased in the first quarter of 2018.

Cost of revenue increased to $1.5 million in the three-month period ended March 31, 2018, compared to $0.8 million in the same period in 2017. The increase was primarily due to greater costs for Pfenex’s Px563L product candidate under its government contract, resulting from increased activity under this contract during the first quarter of 2018, as well as additional sales of reagent protein product.

Research and development expenses increased to $8.8 million in the three-month period ended March 31, 2018, compared to $6.4 million in same period in 2017. This was primarily due to increased activity for PF708 to satisfy the clinical filing requirements for an NDA, which Pfenex expects to submit to the FDA in the third quarter of 2018, assuming sufficiently positive results from its Study PF708-301. These costs were offset by a decrease in expenses due to Pfenex’s decision to pause its development activities on certain product candidates in 2017.

Selling, general and administrative expenses decreased to $4.5 million in the three-month period ended March 31, 2018, compared to $5.7 million in the same period in 2017. The decrease was primarily due to costs incurred in the first quarter of 2017 for the change in senior management.

Cash and cash equivalents as of March 31, 2018 was $47.1 million. Pfenex believes it has sufficient cash to meet its anticipated cash needs for at least the next 12 months. Assuming sufficiently positive results from its PF708-301 study, Pfenex also believes it has sufficient cash resources to fund all necessary activities leading up to and including the expected submission of an NDA for PF708 to the FDA

Omeros Corporation Reports First Quarter 2018 Financial Results

On May 10, 2018 Omeros Corporation (NASDAQ: OMER) reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2018, which include (Press release, Omeros, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348558 [SID1234526489]):

1Q 2018 total and OMIDRIA revenues were $1.6 million, compared to $12.3 million in 1Q 2017; the decrease is the result of the scheduled expiration of OMIDRIA pass-through reimbursement status on January 1, 2018.
The Consolidated Appropriations Act, signed into law in March 2018, includes a provision granting a two-year pass-through extension, beginning on October 1, 2018, for a small number of drugs including OMIDRIA.
Net loss in 1Q 2018 was $30.1 million, or $0.62 per share. Non-cash expenses for 1Q 2018 were $4.3 million, or $0.09 per share. Overall decrease in cash, cash equivalents and short-term investments for the quarter was $10.9 million.
At March 31, 2018, the company had cash, cash equivalents and short-term investments available for operations of $72.8 million. An additional $45.0 million available under the company’s existing credit facility is expected to fund on May 18, 2018.
Patient enrollment began in the OMS721 Phase 3 clinical trial (known as ARTEMIS-IGAN) in patients with Immunoglobulin A (IgA) nephropathy.
OMS721 was granted breakthrough therapy designation for treatment of patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who have persistent TMA despite modification of immunosuppressive therapy.
Following recent interactions with FDA, Omeros believes that it has a clear path to approval for OMS721 in high-risk HSCT-TMA, intends to continue working closely with FDA to achieve this objective and has begun preparations to submit a Biologics License Application (BLA).
OMIDRIA was added to the Veterans Health Administration National Formulary in April 2018.
"During the first quarter of 2018, we made tremendous progress in our MASP-2 program," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We believe that we now have clear paths to accelerated approval for OMS721 in both stem-cell TMA and IgA nephropathy. With breakthrough therapy designations in both of these indications, we look forward to continuing to work closely with FDA and, for stem-cell TMA, we have initiated preparations for a BLA submission. Our PDE7 inhibitor OMS527 is poised to enter the clinic in mid-year and, in late 2019 through 2020, we expect to begin clinical trials for our MASP-3 antibody OMS906 and for our small-molecule MASP-2 inhibitors. A number of our GPCR programs are also moving toward the clinic, providing the potential for wholly new mechanisms for the treatment of a broad range of diseases and disorders, including cancers. With the Omeros team and the reinstatement of CMS separate payment for OMIDRIA, we believe that we will have the resources to deliver on the immense promise of these programs to benefit patients, many of whom have conditions for which there are no treatments."

First Quarter and Recent Developments

Developments regarding OMS721, Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) programs for the treatment of HSCT-TMA, IgA nephropathy, and atypical hemolytic uremic syndrome (aHUS), include:
Omeros announced in April 2018 that the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk HSCT-TMA, specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy designation for OMS721, which last year received the designation from FDA for the treatment of IgA nephropathy.
Omeros recently met with FDA to discuss requirements for approval of OMS721 in high-risk HSCT-TMA. Based on that meeting, Omeros believes that it has clear paths to both accelerated and full approval of OMS721 in this indication. In addition to the data provided to FDA, the Agency requested that the company further characterize the patients treated with OMS721 – all of whom had high-risk TMA – and compile and submit additional information on the historical control population for the purpose of further comparing outcomes across corresponding patients. FDA also requested an analysis plan to assess the company’s biomarker data. Should FDA grant OMS721 accelerated approval for the treatment of high-risk stem cell-TMA patients, the drug would be made commercially available for stem-cell patients with this highly lethal disorder. Concurrently, Omeros would conduct a confirmatory trial for subsequent full approval. Omeros intends to continue working closely with FDA as the company further compiles all required information with the objective of initiating a rolling BLA submission later this year. In Europe, the company is scheduling meetings with regulatory authorities to discuss plans for submission of an application for conditional marketing authorization for OMS721 in HSCT-TMA.
In February and April 2018, Omeros reported new results in patients with HSCT-TMA from the ongoing Phase 2 study. The estimated median survival for OMS721-treated patients was an order of magnitude greater than that for a matched historical control (p<0.0001). After study patients had reached an adequate duration of follow-up, further data analysis examined 100-day mortality, an important measure previously used as an approval endpoint in HSCT. That analysis also showed that OMS721-treated patients had improved survival relative to the historical control (53 percent vs 10 percent; p = 0.0002). Biomarkers of disease (i.e., mean platelet count and mean levels of lactate dehydrogenase and haptoglobin), demonstrated statistically significant improvement. Study patients also showed substantial improvement in red blood cell and platelet transfusion requirements.
In February 2018, the EMA granted OMS721 orphan drug designation in the treatment of IgA nephropathy. Enrollment in the Phase 3 clinical trial ARTEMIS-IGAN is ongoing.
Recent developments regarding OMIDRIA include:
In March 2018, the Consolidated Appropriations Act, 2018 (Consolidated Appropriations Act) was signed into law and included a two-year extension of pass-through reimbursement status for OMIDRIA and a small number of other drugs used during procedures performed on Medicare Part B fee-for-service patients. As a result, OMIDRIA will receive a reinstatement of separate payment beginning October 1, 2018 through September 30, 2020.
OMIDRIA was added to the Veterans Health Administration (VA) National Formulary in April 2018. With its addition to the formulary, the drug is now available in all VA facilities that perform ophthalmic procedures. The initial recommendation is that OMIDRIA be limited to use in high-risk patients as determined by each VA ophthalmic surgeon at his or her discretion.
In April 2018, Omeros announced that the results of four "real-world" clinical studies were presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting held in Washington, D.C. The studies demonstrate significant benefits of OMIDRIA to both patients and surgeons across routine and complex cataract surgery cases performed in high-volume surgery centers, with and without femtosecond laser.
In April 2018, the company’s credit facility with CRG was amended to eliminate the revenue and market capitalization covenants with respect to the twelve-month period ending on December 31, 2018 and to reduce the market capitalization threshold for future periods to three times the aggregate principal amount of loans outstanding (excluding any payment-in-kind loans) on the applicable determination date. Omeros issued five-year warrants to the lenders for up to 200,000 shares of the company’s common stock at an exercise price per share of $23.00, which represents approximately a 70-percent premium to the closing price of Omeros’ common stock at that time. In addition, the company has requested the $45.0 million currently available under the CRG credit facility and expects funding to occur on May 18, 2018.
Financial Results

For the quarter ended March 31, 2018, revenues were $1.6 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $12.3 million for the same period in 2017. On a sequential quarter-over-quarter basis, OMIDRIA revenues decreased $12.2 million, which is attributable to reduced ASC and hospital purchasing following the scheduled loss of pass-through reimbursement status as of January 1, 2018. As part of the Consolidated Appropriations Act, pass-through status for OMIDRIA was reinstated for a two-year period, effective October 1, 2018 through September 30, 2020.

Total costs and expenses for the three months ended March 31, 2018 were $29.3 million compared to $25.0 million for the same period in 2017. The increase in the current year quarter was primarily due to higher manufacturing scale-up costs for the OMS721 programs as Omeros continues to increase production capacity to meet anticipated clinical and commercial requirements as well as to incremental costs associated with initiating the OMS721 IgA nephropathy Phase 3 clinical trial.

For the three months ended March 31, 2018, Omeros reported a net loss of $30.1 million, or $0.62 per share, which included non-cash expenses of $4.3 million ($0.09 per share). In comparison, for the prior year’s first quarter Omeros reported a net loss of $15.1 million, or $0.34 per share including non-cash expenses of $4.4 million ($0.10 per share).

As of March 31, 2018, the company had $72.8 million of cash, cash equivalents and short-term investments available for operations and another $5.8 million in restricted investments. In addition, the company has requested $45.0 million currently available under the company’s existing credit facility and expects funding to occur on May 18, 2018.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 8579459. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 8579459.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.