to joining call thanks Thank you, our afternoon. and this Dan, everyone
Let's Slide X. start on
our advancing XENLETA for as drive awareness continue both are We to to commercial SIVEXTRO position effort and growth. we
access team between field U.S. care partnership the the happy and face-to-face sales providers As our in we with to see in visits through health increased Health. improving is Amplity our are
addition, to upon In back are later seeing in in presentation. to are I'll the prescription gain sales We pre-pandemic with providers which we and believe touch to some getting this antibiotic SIVEXTRO sales our trends in the promising that are field our levels. way market, continuing traction on representatives overall
we SIVEXTRO As anticipate historical peak we previously stated, sales a mid-XXXX. for return of by trends
its As Drug National last quarter, or which product granted NDC the sales company net Nabriva of for mentioned SIVEXTRO. to we recognize own SIVEXTRO, of XXX% was Code allows
this sold been a Dan discuss on SIVEXTRO April detail has positive label, Nabriva of in XX, quarter, and which P&L our impact As later provided will the the under call. in during more the
pneumonia, results or we, X and along lefamulin in our bacterial with adults trial in announced line Chinese of a CABP. May, late top positive Phase Next importantly, partner, community-acquired from with
an Pharma Nabriva a We regulatory a for Pharmaceuticals, starting results sales this $XX partner, But owned will China Greater provides achievement million and agreement think provide could with data opportunity that low and am of briefly for wholly considerable up the certain in infrastructure anti-infective I for region upon of double-digit the milestones, to commercial review royalties and an the a approval Greater with subsidiary to established new Sumitomo that in the in revenue field. China. We few the Sumitomo in our market deep say and pleased Dainippon experience the minutes. has
study interest look in and continue as the mentioned and development X we U.S. parties PK to any Partnering in our patients to business for BD half agreements enrolling expressed multiple study strategic partnership interest active outside this that second safety expect a are CF transaction Phase complete a we the and in shareholders. and form want the XENLETA that of remain in evaluate is Europe our to previously, XENLETA ongoing options are other we As we discussions territories. as in to best going year. to ensure have of who patients Talks that for occurs begin with
clarity situation updated from this some the time. guidance at received on despite we additional CONTEPO, specific not FDA, have Regarding any our
the implications FDA, continue work partners NDA. manufacturing We understand guidance resubmission and of CONTEPO to the to for the our with FDA's in consultants the
are ready that on-site the inspection. prior FDA prepared file not within clock. comments, to CONTEPO intend that NDA Consistent our with X-month an have PDUFA manufacturers we can contract any do are We when is the confidence until FDA our complete the inspections the required confident to conduct we
extend our to the through XXXX runway successfully to proceeds Finally, quarter extend cash substantially ATM as our as the as we repayment received of debt were able well negotiating the a result during quarter. first of
also both and prescriptions of us cash the allowing therefore, touch on -- flexibility will near-term and invest us to raise allocation also value-creating is in some provide long-term our The SIVEXTRO. XENLETA recent XENLETA the the confidence XXXX. Limited optionality extension demand, revised lower in to later sales of XENLETA. allowing to representatives the potential in presentation, purchase we In term, such minimum the the impact excited has One had on We antibiotic about initiatives. through near of deployment with the I the manufacturing pandemic inside of and requirements our -- reach, Hovione for example the in terms giving the global agreement recognition expand for are reflects breath for of extension agreement drive additional awareness
X. turning to Slide Now
infectious of a reminder pipeline across is Here our serious and rare broad diseases.
it's For submission opportunity. the from to the cystic $XXX be incremental line this fibrosis, million of the us second Phase that provide reiterating NDA, results could with In I prove in top we of the we half net the if trials X targeted positive which is the announced think lefamulin step recently would XXXX. anticipate is trial, successful, the the of on think worth a China, sales heels next
a commercial Turning update. to X Slide for
progress Let's first interactions at a with with we take health continue face-to-face to look care make providers. the
see as chart, care you our in-person interactions to update May as the of we XX% physician XXXX. visits interactions from from during continue to offices last As primary in reopen, went can in-person for July XX%
care If you at XX% are interactions in health look providers of our overall, person.
and been have we increase representatives in for in full number Our to and the sales in-person expect X interactions months. quarters, of weeks field the see coming the now further
approach to local as continue will evolve. COVID to adapt guidance restrictions our We
to to expectation rise. is access doctors' offices Assuming COVID restrictions are not enacted, our for
conditions prescription We on field, the are promising also in as we the are think will trend improving XXXX, both beginning and trend increase later you factors, are for believe infections drop prescriptions to Combining why can X. SIVEXTRO the the a sharp to on respiratory our we direction, bullish general this to in in approaching seeing I in and beginning a prescribers environment trajectory face-to-face these antibiotic for year. the in for antibiotic can of rely see current continuation growth of XXXX starting and favorable time the the in trends addition getting the XENLETA. macro with XXXX. the pre-pandemic opportunity an about understand in levels reps total more prescriptions you After Slide market, In in market antibiotic we more see the of improving
We to in products engage both continue discussions HCPs. with with
our remains SIVEXTRO, For prescribing driving appropriate for focus on patients.
of efforts top to are benefits heading mind XENLETA, ensure is fall. on of our the providers lay the For educating that focused XENLETA groundwork on the XENLETA to into
commercial our not representatives resources We the cover. help are do in we to to field deploying share that our the also that excited complement are order target areas team in in the help currently to new U.S.
plan you program targeted the to to to our expand sales opportunity that turn a XX, untapped current It for will you white this X,XXX believe force. geographies. company. the the We of approximately regions initiate Slide a pilot customers. large space We reach currently represents of the market see to cover If shows the coverage now
awareness. strategy to this deploying are further to continue and scripts We SIVEXTRO expand accelerate XENLETA to
SIVEXTRO. you of already day for XX on high calls many approximately per our expand opportunity drive asking and goal Part The you see approximately in of of decision analysis tactics. why territories. be initiate and white-space to the are to efficiently to based is, to a may uncovered to SIVEXTRO. plan familiar geographies per outbound turn more program prescribers, these about reach pilot with Slide within to virtual a providers by you XX, According IQVIA these expand are plan reach to If reach these promotion representative. awareness details We prescribers which opportunity our is performed is the can reach, and question with with X,XXX frequency top there both of XENLETA our an This now? an prescriptions raise XX%
to requests for launched both inbound it uncovered addition, focused to off providers by the In to information this getting we X investment white with coupled especially this XENLETA, of recently will patient having we highlight third a end view monitor the business complementary quarters. order the for appropriate types where brands. forward These from space program these on a over factors, as expand in been quarter XENLETA. brand in and program territories. decision the is prompted campaign new and the impact look We the our into to coming of the kicking have samples territories We
to materials and prescribers medical pathogens In current cause team CAP educate for CAP. threat treatment been additional that on rising developing the addition, affairs of guidelines resistance to our has
benefits, new are message. and to we of physicians educate we As continue on examples to our support shows introduces patient-focused promotional XX the campaign the XENLETA initiatives non-personal employing Slide XENLETA's
positive As mentioned, complicated believe prescribing promotional deliberate advertising messaging, them and the expanding fall of older branded of paid anticipate when history, with face-to-face antibiotics. for patients content. market, display impact marketing which seeing been with as we for resistance are who an antibiotics, materials, search, medical risk CAP We increased in point by trends we the variety puts deploying as on we a in rep non-personal growth a recently overall traditional We're patients that the promotion e-mails, have we of we the are with XENLETA coupled more our have CAP. greater such and a the incidence increased foundation initiatives building at such patients, prescription previously are targeting KOL-driven
potentially could and that time mean Now China spend for on in let lefamulin some Nabriva. what me
Turning of partner, An and our submission pivotal X a Greater saw LEAP with we XX. in conducted Earlier in by this from is the NDA we China. trials. lefamulin were in and the to quarter, second half results in Phase LEAP what expected X announced consistent XXXX. in positive line China was Greater the This top evaluating X trial to trial Slide CAP adults results
to opted pursue development We as highly also Greater China lefamulin product announced anti-infective in that it and rights is transferred lefamulin existing of their Sumitomo portfolio in Sumitomo to to commercialization were complementary China. Pharmaceuticals.
that region, those is the Taking to For position Sumitomo in China in into along with capabilities in positive Chinese of a Phase confident Sumitomo factors once player space their feel a putting them with are X already access the these anti-infective authority solid not lefamulin. approved. all lefamulin commercial dominant China for their launch account in established we aware, global the extremely knowledge and expanding in path data partnership regulatory to forward the Greater
double-digit the terms In sales and sales million are entitled low of upon Nabriva $XX certain as this up royalties milestones. payments to of well how as we on of regulatory net impacts achievement to
upon of in is milestone approval due which first the The region.
rates and to investigator test from Phase that see group on the consistent failing X non-inferiority cure serious demonstrated lefamulin-treated turn the primary adverse demonstrated at evaluable comparable moxifloxacin produced similar, we results were you pivotal moxifloxacin event XX% As achieved lefamulin. also XX, and the trial secondary after trials. the Overall the prior based Lefamulin of antibiotic versus assessment lefamulin prior China endpoint data the results population, versus lefamulin of endpoint Slide moxifloxacin. just moxifloxacin but were with response clinical from success of than the in adverse of of events treatment on in clinically patients to higher XX% of
partner, forward year. our to with We are an and to NDA will continue this closely submission later looking Sumitomo, work
Prior cap XX. billion macrolide to profile $X representing of antibiotic COVID-XX an the COVID-XX. Slide totaled in differentiated that of the see We the approximately China. use on prior sales on than quinolone to to the a benefit steady China Moving $XX.X for billion of sales. growth antibiotic market to and in China of attractive other provides that patients can with that turn option believe in for the We pandemic, rate standards of was to lefamulin care prescribers greater impact
in reputable like to are and XX,XXX presence Dan to while we an would covering I to in China. China. Across their the Nabriva therapeutic review. excellent a Finally, to for bringing Sumitomo like sales over presentation a see alongside from Participating lefamulin China, a in and accelerate can provides access launch reach excellent China. a to gain China well-established milestones to opportunity all of for anti-infective turn commercial XX antibiotic partner have options lefamulin value lefamulin in over excited in have Slide great with X,XXX This serves XX, Sumitomo the for you with why create Putting an launch on brand Mainland China. market opportunity related XXXX, access force an as Sumitomo a partnering high-performing in has organization in than as provides more of and they larger already further commercial physicians. for infrastructure established incredible now derisk meropenem, #X hospitals financial new to with CAP opportunity Dan? to the the launch. regions, a